AAAHC 2020 MDS Handbook MASTER 8 31...Web: The Accreditation Handbook for Medicare Deemed Status, or parts thereof, may not be reproduced in any form or by any means, electronic or

AccreditationHandbookFor Medicare Deemed Status, v41

OUR MISSIONIMPROVING HEALTH CARE QUALITYTHROUGH ACCREDITATION

5250 Old Orchard Rd., Suite 200Skokie, IL 60077Tel: 847.853.6060 E-mail: [email protected] Web: www.aaahc.org

The Accreditation Handbook for Medicare Deemed Status, or parts thereof, may not be reproduced in any form or by any means, electronic or mechanical, including photocopy, recording or any information storage and retrieval system now known or to be invented, without written permission from AAAHC, except in the case of brief quotations embodied in critical articles or reviews. For further information, contact the President & CEO, AAAHC, at the address above.

References are made throughout this handbook to the NFPA 101R Life Safety Code®, 2012 Edition and the NFPA 99® Health Care Facilities Code®, 2012 edition. Both are registered trademarks of the National Fire Protection Association, Quincy, Massachusetts.

©2020 Accreditation Association for Ambulatory Health Care

i Accreditation Handbook for Medicare Deemed Status, v41


Foreword Thank you for choosing the Accreditation Handbook for Medicare Deemed Status, v41 as the resource for your quality improvement journey. At AAAHC, we know that those who seek recognition through our programs understand that “best” is a destination while “better” is the route traveled. For more than 40 years, AAAHC has provided facilities with relevant standards and education for improvement of their patient care environment and has conducted periodic onsite evaluations to assess your compliance. We update our Standards regularly to reflect proven developments in medicine, technology, and specialty practice. While accreditation standards may have changed over the years, our mission to improve the quality of health care through accreditation has not. As we begin our fifth decade of service to ambulatory health care centers, we continue to build on our mission and vision to improve health care one facility at a time. At the core of our mission and vision is the 1095 Strong, quality every day philosophy. 1095 Strong is a commitment to ongoing education and quality improvement, which demonstrates survey readiness not only on the day of the survey but all 1,095 days of the accreditation term. This revised edition of our handbook, the Accreditation Handbook for Medicare Deemed Status, v41, provides the most current information and guidance as it relates to the care of patients and staff within the ambulatory setting. We want to thank our accredited organizations, partner associations, committees, surveyors, staff, and other subject matter experts for the contributions they have made during the review process. AAAHC leverages this expertise to ensure we maintain relevance and bring value to your practice. For v41, the Standards are presented in a new format that includes “elements of compliance,” the presence of which can be evaluated as yes, no, or not applicable (NA). Following each Standard is a ratings chart that defines how many elements must be present to achieve specific compliance ratings, or whether the Centers for Medicare & Medicaid Services (CMS) Condition for Coverage (CfC) necessitates that all “elements of compliance” must be present to achieve compliance. The intent of these changes is to create greater transparency with regard to what AAAHC surveyors will be looking for and to allow organizations the ability to conduct a self-assessment that should align closely to that of the onsite surveyor or survey team. Following an extensive review process which included a public comment period, the 2020 Standards have not substantively changed. The handbook contains the moderate realignment of a few Standards for chapter applicability and/or cohesion. We anticipate a seamless transition for organizations to integrate policies, procedures, or programs to be compliant with the v41 changes. In late 2019, CMS released revisions to the CfC for ambulatory surgery centers regarding hospital transfer agreements and physicians with admitting privileges, the pre-surgical history and physical (H&P), and emergency preparedness plans and drills. AAAHC Standards for the Medicare Deemed Status program are required to meet the CfC, but AAAHC may also choose to exceed them. As you review the Standards in this handbook, note that AAAHC has chosen to exceed some of the revised CfC. A crosswalk of AAAHC Standards and the CfC is provided in the Resource section for your ease in locating specific CfC within the AAAHC Standards. AAAHC is confident that if we work together and are united in the mission of improving health care, we will continue to meet all challenges and opportunities that come along. A trusted and valuable resource for accreditation, AAAHC is also an accessible partner for updates, education, and guidance on industry issues that affect your organization’s business and patient care. We are here to help you stay survey-ready on every day of operation. Noel M. Adachi, MBA Ira Cheifetz, DMD President & CEO Board Chair

ii Accreditation Handbook for Medicare Deemed Status, v41 ©2020 Accreditation Association for Ambulatory Health Care

Acknowledgements We gratefully acknowledge the efforts of the AAAHC Board of Directors, the Standards Development Committee, and the AAAHC staff.

Standards Development Committee (SDC) * Frank J. Chapman, MBA, Chair Medical Group Practice Management, Ambulatory Surgery Center Administration

David M. Shapiro, MD, Vice-Chair Anesthesiology

Dennis Schultz, MD, MSPH, FACOEM, Vice-Chair Occupational Health and Primary Care

R. Bruce Cameron, MDGastroenterology

Karen W. Connolly, RN Health Plan Administration

Jan Davidson, MSN, RN, CNOR, CASC Ambulatory Surgery Center Administration

Meena Desai, MD Anesthesiology

Gerald Fleischli, MD Primary Care

Christine S. Gallagher, RN, BSN, CNOR Ambulatory Surgery Center Administration, Orthopaedics

David Gans, FACMPE Medical Group Practice Management

Susan Griffin, MSM Health Plan Administration

Margaret Haecherl, RN, MSN, CNOR, PHN Quality Adminstration

Irving Hirsch, MD Anesthesiology

Sandra Jones, LHRM, MBA, CASC Ambulatory Surgery Center Administration

Girish Joshi, MD Anesthesiology

Alyson Roby, MD Primary Care

Edwin Slade, DMD, JD Oral and Maxillofacial Surgery

Benjamin Snyder, FACMPE Medical Group Practice Management

SDC Staff Liaisons Meg Kerr, MPA Vice President, Standards Development

Tarin English Assistant Director, Regulatory Compliance

* In 2020, the Standards and Survey ProceduresCommittee was restructured and renamed to heightenfocus on Standards Development and is now namedthe Standards Development Committee.

iii Accreditation Handbook for Medicare Deemed Status, v41


Note to Readers Using this Handbook The Accreditation Handbook for Medicare Deemed Status has been developed to communicate AAAHC policies and procedures, to assist organizations in realistically assessing compliance with AAAHC Standards, and to provide tools and resources to help health care organizations improve the quality of services they provide to patients.

The Standards are presented with rating options tables to provide an easy way to track the results of your self-assessment.

Following the chapters are tools that parallel those used by surveyors while onsite, and additional resources that may be helpful.

Maintaining contact with AAAHC AAAHC frequently uses e-mail to distribute important information to accredited organizations. We rely on each accredited organization to make sure that these communications reach the relevant individual by designating a Primary Contact. If your organization changes its Primary Contact for accreditation, please follow the instructions below to be sure your organization continues to receive important and timely accreditation information.

Refer to the AAAHC website at www.aaahc.org for the Change Notification Form. Send contact information changes on facility letterhead, signed by your organization’s Administrator or Chief Medical Officer via e-mail, fax, or mail as follows:

E-mail: Corporate Quality Alliance (CQA) organizations [email protected]

Surgical organizations

EAST (of the Mississippi River) [email protected]

WEST (of the Mississippi River) [email protected]

Fax: 847.853.9028

Mail: AAAHC Accreditation Services 5250 Old Orchard Road, Ste 200 Skokie, IL 60077

Notice of a change should include the name of the new Primary Contact, his/her job title, phone number, and email address. AAAHC will not accept changes to the Primary Contact over the phone.

iv Accreditation Handbook for Medicare Deemed Status, v41


v Accreditation Handbook for Medicare Deemed Status, v41


Contents

AAAHC Policies and Procedures for Medicare Deemed Status Program ...................................................................................................................................................... 1 Introduction ................................................................................................................................................. 1 Achieving Accreditation as an ASC with Medicare Deemed Status ................................................................ 1 AAAHC Standards ....................................................................................................................................... 2

Application of the Standards .................................................................................................................. 2 Applicable version of the Standards ....................................................................................................... 2 Comments and suggestions about the Standards .................................................................................. 2 Medicare Conditions for Coverage (CfC) for ASCs ................................................................................. 2 AAAHC Physical Environment Checklist for ASCs ................................................................................. 3 Accreditation Process: Before the Survey .............................................................................................. 3

Step 1: Confirm that your organization meets survey eligibility criteria ........................................................... 3 Multisite ASCs seeking the AAAHC MDS Survey ................................................................................... 4

Step 2: Review the types of surveys available............................................................................................... 4 Additional Medicare Deemed Status survey element ..................................................................................... 6

Life Safety Code Survey® (LSC) ........................................................................................................... 6 Medicare Follow-Up Survey .................................................................................................................. 6 Interim Survey ...................................................................................................................................... 6 Random Survey .................................................................................................................................... 6 Discretionary Survey ............................................................................................................................. 6

Step 3: Apply for an onsite survey ................................................................................................................ 7 Obtaining an Application for Survey ....................................................................................................... 7 Business Associate Agreement (BAA) ................................................................................................... 8 A note about confidentiality ................................................................................................................... 8

Step 4: Complete payment and collaborate on survey scheduling ................................................................. 8 Survey fees .......................................................................................................................................... 8 Scheduling ........................................................................................................................................... 8 Accreditation fee cancellation policies .................................................................................................... 8

Step 5: Comply with presurvey responsibilities and prepare for onsite survey ................................................ 9 Responsibilities of the applicant organization ......................................................................................... 9 Public posting of Notice of Accreditation Survey ..................................................................................... 9

The Accreditation Process: During the Survey .............................................................................................. 10 AAAHC survey team ............................................................................................................................. 10 Surveyor conduct during the survey ....................................................................................................... 10 Additions to the survey team ................................................................................................................. 10 AAAHC onsite process .......................................................................................................................... 10 Concluding the survey experience ......................................................................................................... 11

The Accreditation Process: After the Survey ................................................................................................. 11 Accreditation decision and notification ............................................................................................ 11 Plan of Correction (PoC) ................................................................................................................ 11

Medicare Deficiencies .................................................................................................................................. 11 Early Option Survey (EOS) and Initial Accreditation/Initial Medicare Deemed Status Survey ............. 11

Condition-Level Deficiency..................................................................................................... 11 Standard-Level Deficiency ..................................................................................................... 12

Reaccreditation AAAHC Medicare Deemed Status Survey .............................................................. 14 Condition-Level Deficiency..................................................................................................... 14 Standard-Level Deficiency ..................................................................................................... 14

Term of Accreditation ................................................................................................................................... 15 Public Recognition of AAAHC Accreditation .................................................................................................. 15 Denial or Revocation of Accreditation ........................................................................................................... 15

Condition-Level Deficiencies Cited.................................................................................................. 15 ASCs not in compliance with AAAHC Policies and Procedures and/or AAAHC Standards ............................................................................................................... 15

Reasons for denial or revocation of accreditation .......................................................................................... 16 Appeal of accreditation decision ............................................................................................................ 16 Limitations on other rights ..................................................................................................................... 16

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Contents

Continuation of Accreditation........................................................................................................................ 16 Continuation of accreditation following a three-year term ........................................................................ 17 Continuation of accreditation following a significant change .................................................................... 17

End of Accreditation..................................................................................................................................... 17 Compliance with Omnibus Reconciliation Act of 1980 ................................................................................... 18 California State Requirements ...................................................................................................................... 19 California Outpatient Organization ................................................................................................................ 19

Definitions ............................................................................................................................................ 19 Adverse event reporting ........................................................................................................................ 20 Patient death or transfer reporting ......................................................................................................... 20 Patient transfer plan .............................................................................................................................. 20 Liability coverage .................................................................................................................................. 20 Posting the AAAHC Accreditation Certificate.......................................................................................... 20 Written discharge criteria....................................................................................................................... 21 Advanced cardiac life support (ACLS) ................................................................................................... 21 Inform patients of physician license ....................................................................................................... 21

Organization’s Right of Appeal Following Denial or Revocation of Accreditation ............................................. 22 Core Chapters 1. Patient Rights and Responsibilities ........................................................................................................... 25 2. Governance ............................................................................................................................................. 33 3. Administration .......................................................................................................................................... 51 4. Quality of Care Provided .......................................................................................................................... 57 5. Quality Management and Improvement .................................................................................................... 61 6. Clinical Records and Health Information ................................................................................................... 69 7. Infection Prevention and Control and Safety ............................................................................................. 75 8. Facilities and Environment ....................................................................................................................... 89 Adjunct Chapters 9. Anesthesia Care Services ........................................................................................................................ 103 10. Surgical and Related Services ................................................................................................................ 113 11. Pharmaceutical Services ........................................................................................................................ 133 12. Pathology and Medical Laboratory Services ............................................................................................ 141 13. Diagnostic and Other Imaging Services .................................................................................................. 147 18. Teaching and Publication Activities ......................................................................................................... 153 19. Research Activities ................................................................................................................................ 155 20. Overnight Care and Services .................................................................................................................. 157 24. Radiation Oncology Treatment Services ................................................................................................. 163 Tools AAAHC Documentation Requirements ......................................................................................................... 169 Developing Meaningful Quality Improvement Studies .................................................................................... 175 Sample Application for Privileges ................................................................................................................. 182 Credentialing Records Worksheet ................................................................................................................ 193 Clinical Records Worksheet ......................................................................................................................... 197 Personnel Records Worksheet ..................................................................................................................... 201 AAAHC Standards and CMS CfC Related to the Management of Clinical Emergencies ................................. 203 Potential Resuscitation Medications and Equipment ..................................................................................... 204 Physical Environment Checklist (PEC) Introduction ................................................................................................................................................. 205

General notes ....................................................................................................................................... 205 Acronyms ............................................................................................................................................. 206

Standards, Characteristics, and Requirements for ASCs in Conformance with CMS CIC ............................... 207 1. Facility Background Information ...................................................................................................... 207 2. Construction/General ..................................................................................................................... 208 3. Means of Egress ............................................................................................................................ 212 4. Laboratory-Related Requirements .................................................................................................. 224 5. Vertical Opening Protection ............................................................................................................ 225 6. Hazardous Area Protection............................................................................................................. 227 7. Medical Gases ............................................................................................................................... 229 8. Electrical System ........................................................................................................................... 247 9. Interior Finish ................................................................................................................................. 259

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Contents

10. Fire Alarm Systems ........................................................................................................................ 260 11. Corridor Separation ........................................................................................................................ 264 12. Smoke and Fire Protection ............................................................................................................. 265 13. Portable Fire Extinguishers............................................................................................................. 270 14. High-Rise Buildings ........................................................................................................................ 272 15. Building Services ........................................................................................................................... 273 16. Vertical Conveyors ......................................................................................................................... 275 17. Fire Emergency Plans .................................................................................................................... 276 18. Smoking ........................................................................................................................................ 277 19. Furnishings and Decorations .......................................................................................................... 278

Life Safety Code (LSC) Plan of Correction (PoC) .......................................................................................... 279 Resources Standards Revisions .................................................................................................................................... 281 Revised Rating Methodology for AAAHC Standards ..................................................................................... 286 Medicare Certification Process ..................................................................................................................... 287

855B Enrollment Process ...................................................................................................................... 289 Understanding, Planning, and Preparing for a Medicare Deemed Status Survey with AAAHC ........................ 290 1095 Learn Portfolio .................................................................................................................................... 291 Toolkit Resources Crosswalk ....................................................................................................................... 292 Glossary ...................................................................................................................................................... 293 Index .......................................................................................................................................................... 301

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Contents

ix

Accreditation Handbook for Medicare Deemed Status, v41 ©2020 Accreditation Association for Ambulatory Health Care

Acronyms

AO Accreditation Organization

ASC Ambulatory Surgery Center

CCN CMS Certification Number

CfC Conditions for Coverage

CMS Centers for Medicare/Medicaid Services

EOS Early Option Survey

FI Fiscal Intermediary

LSC Life Safety Code®

MAC Medicare Administrative Contractor

MDS Medicare Deemed Status

NFPA National Fire Protection Association

NPI National Provider Identifier Number

PEC Physical Environment Checklist

PoC Plan of Correction

RO Regional Office

SA State Agency

SOM CMS State Operations Manual

QAPI Quality Assessment and Performance Improvement

x Accreditation Handbook for Medicare Deemed Status, v41


AAAHC Policies and ProceduresAccreditation Handbook for Medicare Deemed Status, v41

I N T H I S S E C T I O N

AAAHC Policies and Procedures

Organization’s Right of Appeal Following Denial or Revocation of Accreditation

AAAHC Policies and Procedures

1


AAAHC Policies and Procedures for Medicare Deemed Status Program

Introduction

Through its accreditation programs, AAAHC promotes safe, high-quality patient care and performance measurement in organizations providing health care services in ambulatory settings.

Many types of health care organizations have found AAAHC Standards and survey procedures appropriate and helpful in improving the quality of care they provide as well as the overall effectiveness and efficiency of their operations, including:

• Ambulatory clinics • Ambulatory surgery centers • College and university health centers • Community health centers • Convenient care clinics • Correctional healthcare • Dental practices — individual and group • Diagnostic and other imaging centers • Employer-based healthcare centers • Endoscopy centers • Health plans • Indian health centers • Lithotripsy centers • Military ambulatory health care facilities • Multispecialty group practices • Non-surgical health care networks • Occupational health centers • Office based anesthesia organizations • Office based surgery centers and practices • Oral and maxillofacial surgery practices • Pain management centers • Podiatry practices • Primary care practices, including those that function

as Medical Homes • Radiation oncology centers • Single-specialty group practices • Urgent or immediate care centers • Women’s health centers

Achieving Accreditation as an Ambulatory Surgery Center (ASC) with Medicare Deemed Status In December 2018, AAAHC was granted renewal of its deemed status for Medicare by the Centers for Medicare and Medicaid Services (CMS). ASCs seeking initial Medicare certification and those currently Medicare certified are eligible for the AAAHC Medicare Deemed Status (MDS) Program to validate and recognize their achievements. ASCs seeking initial Medicare certification may use the AAAHC Medicare Deemed Status Survey to demonstrate compliance with the Medicare Conditions for Coverage (CfC) for ASCs in order to receive a Medicare provider number.

The MDS Program integrates the requirements of the Medicare CfC into the AAAHC Standards. Applicants for a MDS Survey should be prepared to demonstrate compliance with all Medicare CfC and all AAAHC Standards detailed in the applicable chapters of this handbook. Some individual AAAHC Standards may not apply depending on the services provided. Prior to submitting a formal Application for Survey, applicants should review the policies, and perform an organizational assessment of their ASC’s compliance with the Standards and requirements in this handbook and in other cited references.

For an Initial MDS Survey, the result of a successful survey is a recommendation to CMS for Medicare certification of your ASC and AAAHC accreditation. For an ASC seeking reaccreditation, the result is continued recommendation for participation with MDS and removal from annual state agency surveys for CMS. CMS retains the authority to conduct random validation surveys and complaint investigations of Medicare-certified ASCs. AAAHC accreditation is voluntary, and seeking deemed status through AAAHC is optional.

The CMS CfCs are incorporated across multiple chapters. Currently, there are 15 CfCs and each has one or more related standard(s). CMS requires Medicare certified ASCs to be in full compliance with all CMS Conditions for Coverage at all times. ASCs must review the language and fully comply with each CMS standard and condition. When there are perceived nuances within a CMS condition that are not addressed by a standard requirement, AAAHC encourages ASCs to review the CMS Interpretive Guidelines for CfCs, which are found in Appendix L of the CMS State Operations Manual:

2 Accreditation Handbook for Medicare Deemed Status, v41 ©2020 Accreditation Association for Ambulatory Health Care


https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/GuidanceforLawsAndRegulations/ASCs

This document is periodically updated by CMS as necessary; ASCs should have the most current version available to maintain compliance at all times.

AAAHC Standards The Standards in this Handbook describe characteristics that we believe to be indicative of an accreditable ambulatory health care organization. The Standards are written in general terms followed by “elements of compliance,” representing the minimum requirements to demonstrate compliance. These elements can be used to perform a pre-survey self-assessment and gap analysis. Surveyors will be looking for evidence that each element is present when performing an onsite survey.

Application of the AAAHC Standards The Standards contained in Chapters 1-11 will be applied to all organizations seeking an accreditation survey.

The Standards in Chapters 12, 13, 18, 19, 20 and 24 will be applied when relevant to the services provided by the organization. Review the introduction to each adjunct chapter to assess applicability to your organization.

Any questions about the applicability or non-applicability of this Handbook, individual chapters or Standards should be directed to the AAAHC office prior to submitting an Application for Survey.

Throughout this Handbook, reference is made to specific documents or standards published by other organizations. Subsequent editions of these publications become the authoritative reference for AAAHC only after they have been approved by the AAAHC Board of Directors or by CMS.

Applicable version of the Standards Periodically, AAAHC releases new versions of the Standards updated for changes in best practice and regulations. Contact AAAHC to determine which version of the Accreditation Handbook for Ambulatory Health Care will apply to your Survey.

Comments and suggestions about the Standards Revisions, additions, or deletions to the Standards for inclusion in the next version are subject to a public comment period of 30 calendar days. Proposed changes are posted at www.aaahc.org. AAAHC solicits and invites comments regarding the proposed changes to the Standards from interested parties.

Following the public comment period, the AAAHC Standards Development Committee submits proposed revisions, additions, and deletions to the existing Standards, all relevant public comments received, and any recommendations in response to the comments to the AAAHC Board of Directors for review, and final approval.

We also welcome comments or suggestions at any time about the relevance, reasonableness, or clarity of any of the Standards. Outside of the annual public comment period, these comments and suggestions should be sent to [email protected]. Changes to AAAHC Standards related to CMS requirements are submitted on an annual basis for CMS approval. The Conditions for Coverage (CfC) are determined by CMS. CMS requires AAAHC to survey for compliance with all CfC during a Medicare Deemed Status Survey. Comments or suggestions regarding CfC should be directed to the relevant CMS Regional Office.

Medicare Conditions for Coverage (CfC) for ASCs Ambulatory surgery centers must be in compliance with the federal requirements set forth by CMS in the Medicare CfC in order to receive Medicare/Medicaid payment. A Medicare Deemed Status Survey of an ASC determines whether it is in compliance with the definition of an ASC, ASC general conditions and requirements, and the CfC at Title 42 CFR 416 Subparts A through C.

As outlined in an ASC’s supplier agreement with CMS, the ASC must meet the CfC specified in Title 42 CFR 416.2, 416.25 and 416.40 – 416.52.

The CfC may be accessed by visiting the following:

1. Electronic Code of Federal Regulations:www.ecfr.gov

Step 1: From the drop-down box, select Title 42—Public Health, then click Go.

Step 2: Select #3 — 414–429, Centers forMedicare and Medicaid Services, Department ofHealth and Human Services.

Step 3: Select Part 416, Ambulatory SurgicalServices.

Step 4: Select Subpart B, General Conditions andRequirements.

Step 5: Scroll down to Subpart C, SpecificConditions for Coverage.

2. CMS webpage: CMS Conditions for Coverage(CfCs) & Conditions of Participation (CoPs)webpage:

https://www.cms.gov/CFCsAndCoPs/16_ASC.asp#TopOfPage.

Step 1: Select Ambulatory Surgical Centers(ASCs) on the left-hand navigation panel

https://www.cms.gov/Regulations-and-Guidance/Legislation/CFCsAndCoPs/index?redirect=/CFCsAndCoPs/16_ASC.asp%23TopOfPage


mailto:[email protected]

http://www.ecfr.gov

3 Accreditation Handbook for Medicare Deemed Status, v41



Step 2: Scroll down to Related Links for CONDITIONS FOR COVERAGE: AMBULATORY SURGERY CENTERS

ASC interpretive Guidelines are available at: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/GuidanceforLawsAndRegulations/ASCs

Evidence of ASC compliance with the regulatory requirements is demonstrated through observations, interviews, and document/record reviews. The survey process focuses on how the ASC delivers patient care, including its organizational functions and processes for the provision of care. The on-site survey is the means used to assess compliance with federal health, safety, and quality standards to ensure that patients receive safe, quality care and services.

As outlined in each chapter, all Medicare requirements are applicable and all Medicare requirements are assessed as compliant (C) or non-compliant (NC) during a Medicare Deemed Status Survey. These Medicare requirements are clearly identified throughout this handbook. Because an ASC must be in full compliance with all Medicare requirements, any such requirements scored as NC are considered a Medicare deficiency.

AAAHC Physical Environment Checklist for Ambulatory Surgical Centers AAAHC has developed a pre-survey assessment tool to assist ASCs in determining whether they meet the requirements of the Life Safety Code® (LSC) and the Health Care Facilities Code. The Physical Environment Checklist for Ambulatory Surgical Centers (PEC) (page 205) provides for schematic review of the fire and life safety issues for a surgical facility seeking certification by CMS as an ASC. It is based on the CMS-approved requirements of the applicable National Fire Protection Association (NFPA) codes and standards, as referenced from the NFPA 101® LSC, 2012 Edition. At the time of this AAAHC handbook release, the 2012 Edition is the only edition recognized by CMS. More current editions of the LSC are not yet recognized by CMS.

In addition, for a facility to operate as a Medicare-certified ASC, Life Safety Code (LSC) Chapter 20 (New Ambulatory Health Care Occupancy), or Chapter 21 (Existing Ambulatory Health Care Occupancy), will apply, regardless of the number of patients served. An ASC cannot be considered a “business occupancy” for purposes of determining LSC compliance.

At least one member of the AAAHC survey team will review and focus on compliance with all Life Safety Code® requirements during the on-site survey.

Accreditation Process: Before the Survey The following steps are intended to guide ASCs seeking Medicare certification and AAAHC accreditation. Other organizations including ASCs that do not seek payment from Medicare/Medicaid, and Medicare-certified ASCs that prefer annual state inspections for Medicare compliance, may prefer to seek only AAAHC Non-MDS Accreditation, the process for which is described in the separate AAAHC Accreditation Handbook for Ambulatory Health Care.

STEP 1: Confirm that your organization meets survey eligibility criteria Organizations are considered for survey by AAAHC on an individual basis. An organization is eligible for an accreditation survey if it meets all of the following criteria. The organization:

1. Has been providing health care services for at least six months before the onsite survey, excluding organizations seeking accreditation through an Early Option Survey (EOS)/Initial Medicare Deemed Status Survey; see page 5.

2. Is either a formally organized and legally constituted entity that primarily provides health care services, or a sub-unit that primarily provides such services within a formally organized and legally constituted entity that may be, but need not be, health related.

3. Attests to its compliance with the AAAHC Survey Eligibility Criteria and to the definition of an ASC set forth by CMS, which can be found in the Code of Federal Regulations Title 42 Chapter IV Subchapter B Part 416.2 Definitions, which states:

Ambulatory surgical center or ASC means any distinct entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization and in which the expected duration of services would not exceed 24 hours following an admission. The entity must have an agreement with CMS to participate in Medicare as an ASC, and must meet the conditions set forth in subparts B and C of this part.

ASC services means, for the period before January 1, 2008, facility services that are furnished in an ASC, and beginning January 1, 2008, means the combined facility services and covered ancillary services that are furnished in an ASC in connection with covered surgical procedures.




Covered ancillary services means items and services that are integral to a covered surgical procedure performed in an ASC as provided in §416.164(b), for which payment may be madeunder §416.171 in addition to the payment for thefacility services.

Covered surgical procedures means those surgical procedures furnished before January 1, 2008, that meet the criteria specified in §416.65 and those surgical procedures furnished on or after January 1, 2008, that meet the criteria specified in §416.166.

Facility services means for the period before January 1, 2008, services that are furnished in connection with covered surgical procedures performed in an ASC, and beginning January 1, 2008, means services that are furnished in connection with covered surgical procedures performed in an ASC as provided in §416.164(a) for which payment is included in the ASC payment established under §416.171 for the covered surgical procedure.

4. Is in compliance with applicable federal, state, andlocal laws and regulations, or, for organizationsoperating outside of the United States, allapplicable laws and regulations.

5. Is licensed by the state in which it is located, if thestate requires licensure for that organization,unless the organization is applying for a surveythat will be used to obtain licensure in a state thatrecognizes AAAHC accreditation for this purpose.

6. Provides health care services under the directionof one of the following health care professionals;(these individuals or groups of professionals mustaccept responsibility for the health care providedby the organization and must be licensed inaccordance with applicable state laws):

a. Doctor of medicine or osteopathy (MD/DO)b. Doctor of dental surgery or dental medicine

(DDS/DMD)c. Doctor of podiatric medicine (DPM)d. Doctor of optometry (OD)e. Doctor of chiropractic (DC)

7. Shares the facilities, equipment, businessmanagement, and records involved in patient careamong the members of the organization.

8. Operates in compliance with U.S. EqualEmployment Opportunity Commission laws.

9. Submits the completed, signed Application forSurvey, all supporting documents, and the non-refundable application fee in advance of thesurvey.

10. Pays the appropriate fees in accordance withAAAHC policies; see Survey Fees, page 8.

11. Acts in good faith in providing complete andaccurate information to AAAHC during theaccreditation process and throughout a term ofaccreditation.

AAAHC reserves the right to reject any application. If AAAHC determines that the Standards and CMS Conditions for Coverage (CfC) cannot be applied, a survey will not be conducted and AAAHC will inform the ASC of the reason for such a decision.

If a survey is conducted and AAAHC determines that the Standards and CMS CfC cannot be appropriately applied in order to reach an accreditation decision, the survey will be deemed a consultation and no accreditation decision will be made. Fees for such a survey will not be refunded.

Multisite ASCs seeking the AAAHC Medicare Deemed Status Survey ASCs with multiple service locations must apply for and be surveyed as separate, independent ASCs. Medicare requires each Medicare certified ASC to have its own unique CMS Certification Numbers (CCN). Multi-site ASCs applying for the AAAHC Medicare Deemed Status Survey may not use a single survey event for more than one location.

The AAAHC Medicare Deemed Status Survey may only be requested by a currently Medicare-certified ASC or one that is seeking Medicare certification. Any other associated entity must request accreditation separately from the ASC seeking Medicare Deemed Status.

STEP 2: Review the types of surveys available Use the chart on the next page to identify what kind of survey to request. All AAAHC Medicare Deemed Status Surveys are unannounced and all accreditation decisions are reported to CMS. Note: Medicare Follow-up, Random, and Discretionary Surveys are survey types scheduled by AAAHC independently of the application process followed by ASCs seeking accreditation or reaccreditation.

If you are unsure about the right survey type for your ASC, contact AAAHC Accreditation Services at 847.853.6060 or via email to [email protected]. For additional information regarding reduction in term or revocation of accreditation, see page 15.

mailto:[email protected]




Apply for one of the following: Are you…

…new to the AAAHC Medicare Deemed Status Program or has your accreditation term lapsed?

EARLY OPTION SURVEY (EOS) / INITIAL MEDICARE DEEMED STATUS SURVEY Some ASCs may have been providing services for less than six months and are seeking AAAHC Accreditation / Medicare Deemed Status for the first time. This survey may be requested by an ASC that meets all of the following criteria. The ASC:

1. Has been legally constituted.

2. Has been open and operation for six months or less.

3. Is able to adequately demonstrate compliance with AAAHC Standards including the Medicare Conditions for Coverage.

A minimum of 10 clinical records must be available for surveyor review. Surveyors must observe a surgery or procedure during the survey.

See page 287 for additional information regarding initial Medicare certification.

OR

INITIAL ACCREDITATION / INITIAL MEDICARE DEEMED STATUS SURVEY This survey is suitable for an ASC that is seeking AAAHC Accreditation and Medicare Deemed Status for the first time or for an ASC with a lapse in accreditation with Medicare Deemed Status (see Continuation of Accreditation, page 16.) The ASC may or may not be currently Medicare-certified but it is not currently accredited with the AAAHC Medicare Deemed Status Survey Program.

OR

RE-ACCREDITATION / INITIAL MEDICARE DEEMED STATUS SURVEY This survey is suitable for an ASC seeking to renew its current AAAHC accreditation and begin participation in the Medicare Deemed Status Program. The ASC may or may not be currently Medicare-certified but it is not currently participating in the AAAHC Medicare Deemed Status Survey Program.

…renewing your participation in the AAAHC Medicare Deemed Status Program?

This survey is suitable for an ASC that is currently AAAHC-accredited and is seeking to renew both its accreditation and its Medicare Deemed Status.




Additional Medicare Deemed Status survey element LIFE SAFETY CODE SURVEY® (LSC)

Except for specific follow-up surveys that do not require review of the physical plant, AAAHC will assess facility compliance with structural and operational requirements. This LSC Survey is a part of the complete Medicare Deemed Status Survey event but it may occur at a separate time. Findings from the LSC Survey will be incorporated into the final survey report. AAAHC reserves the right to determine if a LSC Survey will be conducted in conjunction with intracycle survey types, including Random Surveys (see below). Follow-up Surveys and Interim Surveys may include an assessment of Life Safety Code elements if LSC deficiencies require review.

AAAHC will schedule Interim, Random, and Discretionary Surveys independent of the application process.

MEDICARE FOLLOW-UP SURVEY

A Medicare Follow-Up Survey is required when one or more Medicare condition-level deficiencies are identified during an Intracycle/Medicare Deemed Status Survey. AAAHC conducts this type of survey following receipt of an acceptable Plan of Correction (PoC). The Medicare Follow-up Survey will focus on assessing the ASC’s current compliance with the condition-level deficiencies cited on the previous survey.

The ASC will be assessed a survey fee. See the Medicare Deficiencies section, page 11, more information.

INTERIM SURVEY

This is an unannounced survey performed during the ASC’s term of accreditation and conducted to assess sustained compliance with deficiencies identified in the prior survey.

An Interim Survey is conducted for organizations that are currently AAAHC-accredited and for which oversight is required to assess ongoing compliance with the accreditation Standards. Following the Interim Survey, the organization’s three-year term of accreditation may be maintained or revoked, or it may be determined that another Interim Survey is necessary if the organization is not in substantial compliance with AAAHC Standards. (Medicare Deficiencies, page 11.) Organizations are not eligible for a new accreditation term as a result of an Interim Survey. A survey fee is assessed for an Interim Survey. Following an Interim Survey, the organization will receive an accreditation decision letter and survey report.

RANDOM SURVEY

To support ongoing quality improvement initiatives, an accredited organization may be selected by AAAHC for a Random Survey from 9 to 30 months after an accreditation survey.

Random Surveys are unannounced. Organizations are selected on a proportionate basis across practice settings, geographic areas, and accreditation decision categories. These unannounced surveys, which are typically conducted by one surveyor and may last one full day, are a means by which AAAHC can evaluate the consistency and quality of its program, while also demonstrating to the public and regulators that accredited organizations remain committed to AAAHC Standards throughout the accreditation cycle. Random Surveys also provide AAAHC and its surveyors with opportunities to further engage with accredited organizations in the interval between regular surveys. No fee shall be charged to the organization when a Random Survey is conducted.

If, as a result of a Random Survey, AAAHC determines that the organization is not in substantial compliance with the Standards, the organization’s accreditation term may be reduced, revoked, or it may be determined that an Interim Survey is necessary. (Medicare Deficiencies, page 11.) Organizations are not eligible for a new accreditation term as a result of a Random Survey. (Refer to Denial or Revocation of Accreditation, page 15.) Following a Random Survey, the organization will receive an accreditation decision letter and a survey report.

DISCRETIONARY SURVEY

A Discretionary Survey is conducted “for cause,” when concerns have been raised about an accredited organization’s continued compliance with the Standards. An accredited organization may undergo a Discretionary Survey at any time, without advance notice, and at the discretion of AAAHC. Discretionary Surveys are unannounced. A fee may be charged to the organization when a Discretionary Survey is conducted.

Generally, complaints received by AAAHC concern specific cases or incidents that have occurred in the past. AAAHC evaluates ASCs only for their level of compliance at the time of the survey. However, if an investigation of a complaint substantiates a violation of one or more AAAHC Standards and/or CfC requirements in the past, and there is no evidence that the ASC subsequently implemented effective corrective action, then the findings substantiating the violation are documented in a formal AAAHC survey report.




If an allegation of a violation is substantiated, but the ASC subsequently implemented effective corrective action and the survey reveals no current non-compliant practices, then the ASC is in current compliance and is not cited for a deficiency based on the past non-compliance.

If, as a result of a Discretionary Survey, AAAHC determines that the organization is in violation of one or more AAAHC Standards and/or CfC requirements in the past and there is no evidence that the ASC

subsequently implemented effective corrective action, then the organization’s accreditation term may be reduced, revoked, or it may be determined that an Interim Survey is necessary. (Medicare Deficiencies, page X.) Organizations are not eligible for a new accreditation term as a result of a Discretionary Survey. (Refer to Denial or Revocation of Accreditation, page 15.) Following a Discretionary Survey, the organization will receive an accreditation decision letter and a survey report.

Initial Medicare Deemed

Status (EOS/Initial MDS, Initial/Initial

MDS, Reaccreditation/Initial MDS)

Intracycle Survey (Interim, Random,

Discretionary) Medicare Follow-Up

Less than FC ratings on AAAHC Standards

• PoC required

• Intracycle survey may be required

• PoC required


• PoC required

CMS Condition-level (CfC) deficiency(ies)

• PoC required

• Not eligible for accreditation

• Not eligible for recommendation for CMS certification

• PoC required

• Medicare Follow-up survey is required before decision can be rendered


• PoC required

• Medicare Follow-up survey is required before decision can be rendered


STEP 3: Apply for an onsite survey Any organization that meets survey eligibility criteria (see pages 3-4) may apply. The Application for Survey requires that the applicant organization attest to its compliance with these criteria.

Obtaining an Application for Survey The electronic application available at www.aaahc.org should be completed by each organization seeking a survey. Contact AAAHC if you need assistance with the application.

By submitting an Application for Survey, the ASC:

1. Attests to the accuracy and veracity of the statements therein, and of other information and documentation provided to AAAHC and to the survey team during the survey process.

2. Agrees to comply with all applicable AAAHC and CMS policies and procedures.

3. Understands that AAAHC may use the information supplied in the application and information collected during the survey for quality improvement purposes. Information will not be identified by organization. Refer to A Note About Confidentiality on page 8 for additional information regarding our reporting responsibility to CMS.

An organization must submit a completed application, required supporting documents, and non-refundable application fee before a survey will be scheduled. We recommend submitting the application no more than 150 days prior to the desired survey date or your anniversary date if you are seeking reaccreditation. AAAHC staff will review the application and may request clarification or additional information before it is accepted as complete.

After an organization submits its application and application fee, AAAHC will send an email confirmation.




A complete and accepted application is valid for six months from the date of its acceptance by AAAHC. If the application is incomplete when received, and is not considered complete by AAAHC within six months, or if the organization does not schedule a survey during the six-month period, the application will expire and the organization must submit a new Application for Survey, along with an additional non-refundable application fee.

AAAHC reserves the right to reject any application. If we determine that the Standards cannot be applied, we will not conduct a survey and we will inform the organization of the reason for this decision.

If a survey is conducted and we determine that the Standards cannot be appropriately applied in order to reach an accreditation decision, the survey will be deemed a consultation and the organization will receive a report of the survey findings. Fees for consultative surveys will not be refunded.

Business Associate Agreement (BAA) AAAHC does not maintain, retain, store, or transmit any protected health information (PHI). During the AAAHC accreditation survey process, any documents containing PHI are reviewed by our onsite survey team only to determine compliance with applicable Standards. Organizations should not submit any protected health information to AAAHC.

A Business Associate Agreement (BAA) that addresses AAAHC-specific use of PHI can be found in the Application for Survey documents. An application is not considered complete until the AAAHC BAA is uploaded into the applicant’s file or documentation from an organization describing inapplicability of this requirement is submitted.

A note about confidentiality AAAHC will maintain as confidential all information provided with respect to an ASC that is seeking or has obtained accreditation; will use such information solely for purposes of reaching an accreditation decision; and will not disclose this information to any third party except 1) on prior written authorization from the organization; 2) as otherwise provided in this handbook; or 3) as otherwise required by law or agreement with a state or federal authority. (See note below.)

In submitting its signed Application for Survey, the ASC either provides or authorizes AAAHC to obtain required official records and reports of public or publicly recognized licensing, examining, reviewing, or planning bodies.

In the event that AAAHC determines that an ASC has supplied false, misleading, or incomplete information, AAAHC reserves the right to disclose information about the ASC to obtain accurate or complete information.

Note: For example, AAAHC is required to i) provide relevant survey information to the administrator of the Centers for Medicare and Medicaid Services (CMS) as

part of the AAAHC Medicare Deemed Status accreditation process and ii) report certain negative actions or findings, such as a final determination of termination of accreditation status, to the National Practitioner Data Bank (NPDB) and some state agencies.

STEP 4: Complete payment and collaborate on survey scheduling Survey fees Each survey is tailored to the type, size, and range of services offered by the organization seeking accreditation. The length of the onsite visit and the number of surveyors AAAHC schedules are based on review of the information in the organization’s Application for Survey and supporting documents. These factors determine the survey fee.

Questions regarding the scope of a survey or the estimated survey cost should be directed to the AAAHC office before the survey.

Except where prohibited by law, the survey fee must be paid upon receipt of the survey invoice. Organizations will not receive an accreditation decision unless all survey fees are paid in full.

Note: If an Interim Survey and/or a Medicare Follow-up Survey are required, the ASC will be assessed a survey fee. Factors considered in determining these fees include the size, type, and range of services provided by the ASC, as well as the number and types of deficiencies found at the prior survey. See Interim Surveys on page 6.

Scheduling Medicare Deemed Status Surveys are conducted on an unannounced basis. The date(s) of the survey and the names of the surveyors are not disclosed to the ASC prior to the survey.

The survey must be conducted when the ASC is open for business and providing services.

Because surveyors must observe at least one surgery, current hours of ASC operation must be provided to AAAHC throughout the application and scheduling processes. If, at the time of the survey, the applicant ASC does not have a procedure scheduled or patients refuse to allow the survey team to observe, the ASC may incur the cost of an additional survey so that a surveyor may observe the procedure.

AAAHC will provide information prior to the survey regarding what an ASC may expect during and immediately following the actual on-site survey visit.

Accreditation fee cancellation policies • Accreditation application fees are non-refundable.

• A request for postponement or cancellation of a scheduled survey must be submitted in writing to AAAHC and the organization is subject to the following fees.




• If the postponement/cancellation request is received within 48 hours of survey confirmation, the ASC remains responsible for all direct and indirect, non-refundable costs associated with the cancelled survey, including, but not limited to, costs incurred for surveyor transportation and lodging.

• If the postponement/cancellation request is received more than 48 hours after the ASC has received survey confirmation, the ASC is responsible for the entire survey fee.

An ASC that is undergoing a Medicare Deemed Status Survey may not cancel only the Medicare portion of the survey during or after the conduct of that survey.

STEP 5: Comply with presurvey responsibilities and prepare for the onsite survey Responsibilities of the applicant organization The accuracy and veracity of information provided by an organization seeking accreditation or reaccreditation is critical to the integrity of our program. Such information may be derived from documents supplied by the organization, delivered verbally, or obtained through direct observation by AAAHC surveyors. AAAHC requires that each organization enter into the accreditation relationship and process in good faith.

An organization’s duty to provide complete and accurate information continues during the entire accreditation experience. If an organization experiences significant changes after it submits an Application for Survey, but before an accreditation decision is reached, the organization must notify AAAHC in writing within five business days of this change. For a list of what may constitute a significant change, see Continuation of accreditation following a significant change on page 17. Failure to notify AAAHC promptly may result in immediate termination of an application or immediate revocation of accreditation.

Failure to participate in good faith during the accreditation process and during any subsequently awarded term of accreditation, including, but not limited to, the submission of falsified, inaccurate, or incomplete documents or information, or failure to pay applicable fees, may be grounds for denial or revocation of an ASC’s accreditation status; for terminating an application or an appeal; or for ceasing to do business with the ASC. When an ASC fails to act in good faith, it forfeits its right to appeal or reconsideration of any such action by AAAHC.

In the event that an application or appeal is terminated, AAAHC is entitled to retain the application and survey fees or any other applicable fees paid by the ASC. Any actions taken by AAAHC will be reported to the CMS Regional Office and Central Office.

Public posting of the Notice of Accreditation Survey Shortly after completing the application, the applicant ASC’s primary contact person will receive a packet of information about the unannounced site visit. The packet includes a general outline of the survey event, a listing of documents surveyors may request for review, a copy of the Notice of Accreditation Survey for posting, and other survey information.

For all survey types except Random and Discretionary Surveys the notice must be posted prominently throughout the ASC for a minimum of 30 calendar days or through the end of the survey, whichever is later.

You may photocopy the notice to achieve significant visibility.

The goal of the notice is to provide an opportunity during the onsite survey for patients, staff and members of the general public to present relevant information about the organization’s provision of health care or its compliance with the AAAHC Standards and Medicare CfCs. Alternatively, individuals may present such information in writing to the AAAHC office. All information received from individuals will be considered for relevance and accuracy during the accreditation process. The findings may be included in the survey report if applicable.

The schedule for public presentation of information during the survey will be handled by AAAHC. Any such requests received by the organization should be referred to the AAAHC office.

The opportunity for individuals to present information in person is usually scheduled during the morning of the first survey day and normally does not exceed one hour. The time and length of the session should be agreeable to all parties concerned, but final authority for such matters rests with the AAAHC survey chairperson. The surveyed organization will provide reasonable accommodations for the session, which is chaired by the AAAHC surveyor. AAAHC will inform the requesting individual of the date, time, and place for the presentation of information to the survey team.

If the notice is not posted, the survey will take place, but the accreditation decision will be held until the notice has been posted for 30 calendar days. If the notice is not posted and a request to present relevant information is received by AAAHC, a surveyor may be sent, at the surveyed organization’s expense, to receive the information.




Accreditation Process: During the Survey AAAHC survey team Although an accreditation survey is evaluative, AAAHC emphasizes the educational benefits of accreditation. AAAHC uses health care professionals and administrators to conduct surveys. These dedicated individuals offer their time to train and work as surveyors and use their practical knowledge in the consistent application of the Standards.

A Medicare Deemed Status Survey of an ASC is conducted by surveyors selected by AAAHC. Surveyors are physicians, dentists, podiatrists, pharmacists, registered nurses, Life Safety Code experts, ambulatory health care facility administrators and other health care professionals who are in active practice and/or have substantial experience in ambulatory health care.

Specific survey team members are selected, to the extent possible, on the basis of their knowledge of and experience with the range of services provided by the ASC seeking accreditation. In the interest of objectivity, AAAHC cannot honor requests for specific surveyors.

Surveyor conduct during the survey Surveyors are representatives of AAAHC. Their priorities when conducting surveys are to be ambassadors of AAAHC, objective fact finders, and educators.

A surveyor may not participate in surveys of organizations that may be in direct competition with that surveyor’s business interests, or that bear any significant beneficial interest to the surveyor or the surveyor’s immediate family.

Additionally, while serving as representatives of AAAHC, surveyors may not solicit personal business or take part in any activities that appear to be in furtherance of their personal, entrepreneurial endeavors.

In support of these policies, surveyed organizations should refrain from offering consultative or other types of business to their AAAHC surveyor(s), and/or to members of the surveyors’ immediate families. Please immediately report a survey team conduct concern or question to AAAHC at 847.853.6060.

Additions to the survey team An organization that applies for a survey accepts possible additions to the survey team as determined by AAAHC, as follows:

• Observers: AAAHC staff and individuals approved by AAAHC may observe a survey as part of staff development and ongoing quality improvement of the accreditation process. Observers do not participate in the onsite survey process in any manner.

• Additional surveyors: AAAHC reserves the right to assign additional surveyors as part of ongoing

surveyor education procedures. All surveyors may actively participate in the onsite survey process.

The presence of observers or extra surveyor(s) does not result in any additional charge to the ASC. It may not serve as grounds for any challenge to the accreditation outcome.

AAAHC onsite process The survey team will be comprised of two parts. One or more surveyors will review the clinical and administrative aspects of the ASC. Typically, one additional Life Safety Code (LSC) surveyor will review the facility/physical plant to ensure compliance with 416.44 Condition for Coverage: Physical Environment. In order to facilitate the review of the facility/physical plant, the LSC surveyor will need access to areas as described in the Physical Environment Checklist.

The survey team will arrive on an unannounced basis. The LSC surveyor may arrive with the survey team or at a different day and time. Surveyors will present appropriate personal identification and will announce that the survey is to begin.

When arriving at the survey site, the surveyor/survey team will provide identification, introduce themselves, and conduct a brief orientation conference for the organization. The surveyor or the survey chair will provide an overview of the agenda, request needed documents, and ask that your team identify key personnel who will provide information and the access necessary to complete the survey. This is also a time for you to introduce leaders and staff and to ask questions about the anticipated survey activities.

You will be asked in advance to have specific documents and other information available for surveyors during the onsite visit. This allows surveyors to gather and review information with minimal disruption to the daily activities of your organization. However, surveyors may ask to see additional documents or may request additional information while onsite.

Organizations are asked to make a workspace available for surveyor use. This private or semi-private area may be used to review policies, conduct interviews, and hold survey team meetings to discuss findings.

Surveyors must observe a surgery or procedure. An organization’s failure to provide information requested by AAAHC or its surveyors, or an organization’s failure to allow surveyors to observe a surgery or procedure, may be grounds for termination of the survey or accreditation process.

Organization consultant participation in the AAAHC accreditation survey is limited to attendance at the opening conference and/or the summation conference. The AAAHC survey chairperson has the right to limit or exclude the participation of any individual(s) in any or all parts of AAAHC onsite accreditation survey activities.




Concluding the survey experience At the end of the on-site survey, the surveyors hold a formal summation conference at which they present their findings to representatives of the organization for discussion and clarification. The surveyors are “fact finders” for AAAHC and do not render the final accreditation decision, so no information regarding an accreditation decision is provided during this conference. Members of the organization’s governing body, medical staff, and administration are encouraged to take this opportunity to comment on or rebut the findings, as well as to express their perceptions of the survey.

Accreditation Process: After the Survey Organizations are encouraged to provide feedback about the entire survey process, surveyor(s), and decision release. An organization’s feedback will have no bearing on the accreditation decision.

Accreditation decision and notification Accreditation decisions are made by the AAAHC Accreditation Committee after review of the information gathered and documented during the survey, and documented in the surveyor’s report, any other applicable supporting documents, and recommendations of surveyors and AAAHC staff. All documents reflecting the opinions or deliberations of any AAAHC surveyor, staff member, committee member, or its officers or directors constitute peer review materials and will not be disclosed to the organization seeking accreditation or to any third party.

Accreditation is awarded to organizations that demonstrate substantial compliance with the applicable Standards and CfCs and adhere to AAAHC accreditation policies. Compliance with each requirement is assessed through at least one of the following means:

1. Documented evidence.

2. Answers to detailed questions concerning implementation.

3. Onsite observations and interviews by surveyors.

A surveyor, staff member, or member of the AAAHC Board of Directors who is in any way affiliated with an organization, or whose participation represents a conflict of interest, will not participate in deliberations or voting relative to the accreditation status of that organization. The organization will be notified in writing of the accreditation decision and will receive a detailed report of the survey findings.

In the event that a decision is made to deny accreditation, the organization usually has an opportunity to provide additional information before a final denial decision is rendered, and the final denial decision is subject to the organization’s right of appeal.

When the accreditation decision is based on findings from a survey, the decision is based on the organization’s compliance with the AAAHC Standards in effect at the time of the survey.

In the event that a decision is made to revoke accreditation, the organization will be notified of the revocation of accreditation, including the effective date. (See Denial or Revocation of Accreditation, page 15.)

Plan of Correction (PoC) CMS and AAAHC require that an ASC submit a Plan of Correction when deficiencies are cited. The PoC must be submitted electronically to AAAHC within 10 calendar days of receiving the formal letter of request and instructions from AAAHC. The PoC form includes:

• Standard or CfC identifier

• Survey findings

The following fields are provided for the ASC to complete corrective actions including all steps taken to bring the facility into compliance and the processes that lead to the deficiency cited.

• Title of the party responsible for PoC implementation

• Implementation timeline and completion date

• Monitoring activities to ensure that the plan of correction is effective and that the specific deficiency cited remains corrected and/or in compliance with the regulatory requirements

The next survey team will verify that the documented corrective actions were addressed in the timeframe provided by the ASC.

If an ASC fails to submit its PoC within the required timeframe, accreditation and recommendation for participation in Medicare Deemed Status may be denied. The AAAHC Medicare Deemed Status program provides a 30-day timeframe for corrections to be made. Eligible corrective actions related to physical plant compliance exceeding this timeframe may require CMS Regional Office review and approval.

Medicare Deficiencies Early Option Survey (EOS) and Initial Accreditation/ Initial Medicare Deemed Status Survey

Condition-Level Deficiency

If a Medicare CfC condition-level deficiency, or a series of standard-level deficiencies that could result in a condition- level deficiency, has been identified during this survey or identified in the survey report, then:

• AAAHC will send notification that the ASC will not be granted an accreditation term or recommended for Medicare Deemed Status.




• AAAHC will send the ASC a Medicare deficiency letter within 10 business days after the survey.

• The ASC is required to develop and submit an acceptable Plan of Correction (PoC) to AAAHC within 10 calendar days of receiving the letter.

• If the ASC disagrees with any of the survey findings, it must indicate this in the PoC, as this is the only mechanism by which a survey finding can be contested. It is acceptable to contest a finding if the ASC believes it was in compliance at the time of the survey. The ASC must provide evidence in existence at the time of survey to support its position.

Note: Corrections made during or after the survey are not sufficient to contest a survey finding.

• AAAHC will send final notification regarding receipt of an acceptable PoC, and accreditation and Deemed Status recommendation status. The ASC may immediately apply for another AAAHC Medicare Deemed Status Survey.

If applying for a subsequent Initial Accreditation/Initial Medicare Deemed Status Survey, please note:

• The existing 855B notification letter must remain valid.

• If a new 855B has been submitted, the ASC must submit the most current letter from the fiscal intermediary or carrier stating that the application has been accepted and is complete.

• New application and survey fees will apply.

Note: An ASC that has a CMS Certification Number (CCN) but is undergoing an lnitial Medicare Deemed Status Survey will not be eligible for accreditation if condition-level deficiencies are found. However, the ASC may be eligible for a focused re-survey after successful completion of the Plan of Correction. Fees for a focused re-survey will be determined by AAAHC. AAAHC does not guarantee that a focused re-survey will result in accreditation or a recommendation for certification.

Standard-Level Deficiency

If a Medicare CfC standard-level deficiency has been identified during the survey, then:

• The ASC will be eligible for an accreditation term and a recommendation for Medicare Deemed Status.

• AAAHC will send the ASC a Medicare deficiency letter within 10 business days of the survey.

• The ASC must develop and submit an acceptable PoC to AAAHC within 10 calendar days of receiving the letter. The ASC is expected to submit supporting documents for correcting its deficiencies when the PoC is submitted. Submission of the PoC without supporting documents marks the PoC as incomplete and not acceptable.

(Continues on page 14)

After the AAAHC Medicare Deemed Status Survey

No CMS CfC or accreditation deficiencies

CMS CfC condition-level

deficiencies CMS CfC standard-level deficiencies

Accreditation Standard

deficiencies Following an Initial Deemed Status Survey (ASCs not currently in the Medicare Deemed Status Program) 1. AAAHC sends PoC request

letter within 10 days of survey No Yes Yes Yes

2. PoC required and due to AAAHC within 10 days of request

No Yes Yes Yes

3. AAAHC may grant accreditation

Yes (effective date of accreditation / last day of

survey) No

Yes (effective date of acceptable PoC

receipt) Yes

4. AAAHC may recommend deemed status

Yes (effective date of accreditation/last day of

survey) No

Yes (effective date of acceptable PoC

receipt) Yes

5. Medicare Follow-up Survey NA NA NA NA 6. Recommend MDS after

Follow-up Survey, if in compliance

NA NA NA NA

7. Eligible for an Interim Survey No No Yes Yes




After the AAAHC Medicare Deemed Status Survey (cont.)

No CMS CfC or accreditation

deficiencies

CMS CfC condition-level

deficiencies CMS CfC standard-level deficiencies

Accreditation Standard

deficiencies

Following a Reaccreditation Deemed Status Survey (ASCs currently in the Medicare Deemed Status Program) 1. AAAHC sends PoC request



No Yes Yes Yes

3. AAAHC may grant continued accreditation (effective the day after current term expires)

Yes Yes Yes Yes

4. AAAHC may recommend continued deemed status Yes Yes Yes Yes

5. Medicare Follow-up Survey No Yes No No 6. Recommend MDS after


NA Yes NA NA

7. Eligible for an Interim Survey No Yes Yes Yes Following an Intracycle Deemed Status Survey (Interim, Medicare Follow-Up, Discretionary, Random) 1. AAAHC sends PoC request



No Yes Yes Yes

2. AAAHC may grant continued accreditation (not eligible for a new 3-year term)

Yes Yes Yes Yes

3. AAAHC may recommend continued deemed status

Yes Yes Yes Yes

4. Medicare Follow-up Survey No Yes No No 5. Recommend MDS after


NA Yes NA NA

6. Eligible for an Interim Survey No Yes Yes Yes

Notes Initial Deemed Status Survey If a currently Medicare certified ASC has an Initial Deemed Status Survey and is not recommended for deemed status, AAAHC will report to CMS that deemed status was not recommended. CMS forwards the information to the state agency that will be responsible for that ASC. The ASC may continue to maintain Medicare certification under the oversight of the state agency.

Reaccreditation Deemed Status or Intracycle Survey If a currently Medicare certified ASC has a Reaccreditation Deemed Status or Intracycle Survey and fails to come into compliance with a Medicare condition, it could result in termination of AAAHC accreditation and Medicare Deemed Status. AAAHC will report this termination to the CMS central office and the applicable RO.




• If the ASC disagrees with any of the survey findings it must indicate this in the PoC, as this is the only mechanism by which a survey finding can be contested. It is acceptable to contest a finding if the ASC believes it was in compliance at the time of the survey. The ASC must provide evidence to support its position.


• After submission of an acceptable PoC, the ASC will receive notification of the accreditation decision and recommendation for Medicare Deemed Status. The date for both the accreditation and recommendation for participation in Deemed Status will be the date of receipt of the acceptable PoC, unless the ASC is undergoing corrective activity. The accreditation decision and recommended effective date for Medicare deemed status will be reported to the CMS RO and CMS CO.

Reaccreditation AAAHC Medicare Deemed Status Survey Condition-Level Deficiency

If a Medicare CfC condition-level deficiency or a series of standard-level deficiencies that could result in a condition- level deficiency have been identified during the survey or identified in the survey report, then:

• The ASC may be eligible for accreditation and continued Medicare deemed status.


• The ASC must submit an acceptable Plan of Correction (PoC) to AAAHC within 10 calendar days of receipt of the letter.

• If the ASC disagrees with any of the survey findings it must indicate this in the PoC, as this is the only mechanism by which survey findings can be contested. An ASC contesting a finding must submit documented evidence in existence at the time of the survey that the finding(s) was (were) in compliance. Corrections made during or after the survey are not sufficient to contest a survey finding.

Note: ASCs are encouraged to submit corrections along with objections in order to prevent further delay if an objection is denied.

• The ASC must undergo an unannounced Medicare Follow-up Survey to ensure that correction of the condition-level deficiency(ies) has been implemented appropriately. A survey fee will be assessed.

• The ASC will receive notification of the accreditation decision and recommendation regarding renewal of Medicare Deemed Status. ASCs continuing in the AAAHC Medicare Deemed Status Program will maintain accreditation and participation effective the day after the current term expires.

• The final accreditation decision and recommendation regarding Medicare deemed status will be sent to the organization and reported to the CMS RO and CMS Central Office at the same time.

• If an ASC fails to come into compliance with a Medicare condition as identified during the Medicare Follow-up Survey, it could result in termination of accreditation from AAAHC and of Medicare deemed status. AAAHC will report this termination to the CMS central office and the applicable RO.

Standard-Level Deficiency

If a Medicare CfC standard-level deficiency has been identified during the survey or identified in the survey report, then:

• The ASC will be eligible for an accreditation term and continuation for Medicare deemed status.


• The ASC is required to submit an acceptable PoC to AAAHC within 10 calendar days. If the ASC disagrees with any of the survey findings it must indicate this in the PoC, as this is the only mechanism by which a survey finding can be contested. It is acceptable to contest a finding if the ASC believes it was in compliance at the time of the survey. The ASC must provide evidence in existence at the time of the survey to support its position.


• After submission of an acceptable PoC, the ASC will receive a notification of the accreditation decision and recommendation for Medicare deemed status. ASCs continuing in the AAAHC Medicare Deemed Status Program will maintain accreditation and participation effective the day after the current term expires.

• The accreditation decision and continuation of Medicare deemed status will be reported to the CMS RO.




Term of Accreditation Accredited organizations are expected to maintain compliance at all times with the current AAAHC Standards. Following an AAAHC Medicare Deemed Status Survey, an ASC may be awarded a three-year term of accreditation, a three-year term with interim activities (e.g., Medicare Follow-up Survey, Interim Survey), or it may be denied accreditation. For ASCs that undergo an EOS, intracycle activities (e.g., Interim Survey) may be required. A survey fee will be assessed for any required intracycle activities.

AAAHC awards accreditation for three years when we conclude that an organization is in substantial compliance with the Standards, and there are no reservations about the organization’s continuing commitment to provide high-quality patient care and services consistent with the Standards. Most organizations that have made a good faith effort to achieve and maintain accreditable status are successful in reaching this goal. AAAHC staff are available throughout an organization’s term of accreditation to provide assistance and guidance.

Organizations may receive a three-year term with required intracycle activity–such as an Interim Survey (see page 6)—for continued assessment of ongoing compliance with the Standards. When deficiencies are cited during a survey, organizations must implement corrections in a timely manner. The organization’s corrective actions should be documented and this documentation made available upon request by AAAHC and during subsequent surveys.

Note: Organizations that are owned by a solo health care provider and either (1) the organization or the provider is the subject of a governmental investigation or criminal indictment (other than a traffic violation); or (2) the health care provider’s license to practice is on probationary status, will be required to undergo an Interim Survey each year of the term or until the physician’s license is no longer on probationary status. A survey fee will be assessed for each survey event.

Public Recognition of AAAHC Accreditation The AAAHC Certificate of Accreditation is recognized as a symbol of quality by third-party payers, medical organizations, insurance companies, state and federal agencies, and the public. AAAHC displays a searchable list of currently accredited organizations at www.aaahc.org.

AAAHC-accredited organizations are encouraged to publicly display their certificate. It is the responsibility of each organization to comply with any state regulations which may specify posting requirements. Please note that the AAAHC certificate will reflect the legal name of the organization, as well as one additional name, if appropriate (i.e., “doing business as”). Representation of AAAHC accreditation to the public must accurately reflect the AAAHC-accredited entity.

Only locations accredited by AAAHC may obtain and/or display the Certificate of Accreditation. All certificates remain the property of AAAHC and must be destroyed if the organization loses its accreditation for any reason.

To submit feedback about an accredited facility, the public may be referred to:

https://www.aaahc.org/contact-us/feedback-about-organization/

Denial or Revocation of Accreditation Condition-Level Deficiencies Cited

AAAHC denies accreditation to an organization after an Initial Medicare Deemed Status or an EOS/Initial Medicare Deemed Status Survey, when the survey team finds one or more Medicare condition-level deficiencies or a series of standard-level deficiencies that could result in a condition-level deficiency. The organization will not be granted an accreditation term nor will it be recommended for Medicare deemed status. The right to appeal is not applicable to such ASCs.

The organization is informed that it may apply for another Medicare Deemed Status Survey. When AAAHC denies accreditation, the results will be reported to the appropriate CMS RO.

For more detailed information, see Medicare Deficiencies, pages 11-14.

ASCs not in compliance with AAAHC Policies and Procedures and/or AAAHC Standards AAAHC also denies accreditation to an ASC when it concludes that the organization is not in compliance with AAAHC Standards and/or AAAHC policies and procedures, even if it minimally satisfies all the CMS Conditions for Coverage. When the accreditation decision is based on findings from a survey, the denial decision is based on the organization’s compliance with the AAAHC Standards in effect at the time of the survey.

When AAAHC denies accreditation, the results will be reported to the appropriate CMS RO and CMS Central Office.

https://www.aaahc.org/contact-us/feedback-about-organization/




Reasons for denial or revocation of Accreditation AAAHC reserves the right to revoke or deny the accreditation of any organization at any time without prior notice. Revocation or denial of accreditation may occur if we determine that an organization:

1. No longer satisfies AAAHC Survey Eligibility Criteria.

2. Is no longer in compliance with AAAHC policies, procedures, or Standards.

3. Has significantly compromised or jeopardized patient care.

4. Fails to act in good faith in providing data and other information to AAAHC.

5. Fails to notify AAAHC within 15 calendar days of any significant change. For a list of what may constitute a significant change, see Continuation of accreditation following a significant change on page 17.

6. Fails to notify AAAHC within 15 calendar days of an imposed sanction, change in license or qualification status, governmental investigation, criminal indictment, guilty plea or verdict in a criminal proceeding (other than a traffic violation), or any violation of state or federal law with respect to the organization, its owners, or its health care professionals.

7. Fails to allow a surveyor timely access to the organization to conduct a survey.

In addition, AAAHC may reduce or revoke the term of accreditation of an organization when we determine that there is a material change in the organizational structure, financial viability, operations, ownership, or control of the organization, or in its ability to perform services such that a new survey is required to determine compliance with AAAHC Survey Eligibility Criteria or Standards. Revocation may be retroactive to the date of the material change, the imposition of sanctions, or the violation of law.

Appeal of accreditation decision Generally, a decision of denial or revocation of accreditation by AAAHC generally may be appealed unless otherwise stated within these policies. The appeal of any decision is governed by AAAHC appeal procedures in effect at the time of the appeal. Refer to Organization’s Right of Appeal Following Denial or Revocation of Accreditation on page 22.

In the unlikely event that an applicant ASC, after exercising its right to appeal and upon final decision by the AAAHC Board of Directors, seeks further appeal, the applicant shall have the right to submit such decision for settlement by arbitration administered by the American Arbitration Association in Chicago, IL in accordance with its Commercial Arbitration Rules. Judgment on the award rendered by the arbitrator(s) may be entered in any court having jurisdiction thereof.

An organization that is not granted accreditation, or that has its accreditation revoked based solely on failure to comply with AAAHC policies and procedures and/or Standards, may apply for another full survey at any time following the decision, as long as it has not exercised its right to appeal. The organization must submit a completed, signed Application for Survey, supporting documentation, and the application fee when applying for another survey.

Limitations on other rights The applicant waives all other rights to sue or to resolution of any such claims against AAAHC, its officers, directors, employees, agents, surveyors, and members of its committees in a court of law. The applicant recognizes and agrees that it shall not be entitled to monetary damages, whether compensatory, consequential, collateral, punitive, or otherwise, from AAAHC, its officers, directors, employees, agents, surveyors, and members of its committees as a result of any controversy or claim with AAAHC arising out of any procedures or decision with respect to accreditation.

Continuation of Accreditation An accredited organization acts as an advocate for its patients and the community through the provision of quality patient care. Therefore, accredited organizations are required to maintain their operations in compliance with the most current AAAHC Standards and policies and Medicare CfCs throughout their accreditation term. This involves correcting any deficiencies cited during a survey in a timely manner and implementing continuous quality improvements to maintain ongoing compliance. AAAHC reserves the right to amend its Standards and policies so long as it provides all accredited organizations with notice of such amendments, or includes such amendments in the most recent edition of the handbook.

Medicare Deemed Status is a voluntary program. An organization indicates in its application that it is requesting the AAAHC Medicare Deemed Status Survey. If an organization underwent a previous Medicare Deemed Status Survey and would like to continue its Deemed Status, it must request the AAAHC Medicare Deemed Status Survey.

If a previously deemed organization no longer wishes to participate in the AAAHC Medicare Deemed Status Program, it must submit a written request to AAAHC to withdraw from the program. AAAHC is required to report organization participation in the program to CMS on a regular basis. If an organization’s accreditation lapses and it was a participant in the program, the lapse in accreditation is also considered a lapse and withdrawal from Medicare deemed status. Withdrawals are reported to the appropriate CMS RO and the CMS Central Office. Upon withdrawal from the program, the ASC will be subject to routine surveys by its state survey agency to determine compliance with Medicare CfCs.




Continuation of accreditation following a three-year term Currently accredited organizations must undergo full, regular surveys at least once every three years in order to retain accreditation status. Organizations must complete and submit an application, supporting documentation, and the non-refundable application fee for each Reaccreditation cycle.

Note: All AAAHC Medicare Deemed Status surveys are unannounced

To prevent a lapse in accreditation, an organization seeking Medicare Deemed Status Renewal, should submit a completed application and required documentation to AAAHC no less than 150 calendar days prior to its accreditation expiration date.

Submission of a late application, even if complete, fewer than 60 calendar days before the accreditation expiration date will result in a lapse of accreditation, and an Initial Accreditation/Initial Medicare Deemed Status survey will be scheduled for the organization.

Continuation of accreditation following a significant change Organizations must notify AAAHC in writing within 15 calendar days of significant organizational, ownership, operational, or quality of care events, including interruption in delivery of health care, criminal indictment, guilty plea or verdict in a criminal proceeding (other than a traffic violation) directly or indirectly involving the organization or any of its officers, administrators, physicians/health care professionals, or staff within their role in the organization. Any such change/event that negatively affects public perception of the accredited organization or AAAHC, as the accrediting body, must also be reported. An organization’s duty to provide this information begins with submission of an Application for Survey and continues during the entire accreditation term. If no reportable events occur, an organization is expected to demonstrate knowledge of these reporting requirements during the onsite survey in order to comply with Standard 2.I.L Notice is made by completing and submitting the required Change Notification Form. The form and instructions for relevant documentation to include for specific changes can be found at:

https://www.aaahc.org/accreditation/accreditation-general-information/organizational-changes/

In the event that the organization is exercising its right of appeal, the organization must notify AAAHC in writing immediately of any such changes. Failure to do so may result in an immediate revocation of accreditation, or termination of the right to appeal.

Accreditation is not automatically maintained when an accredited organization undergoes significant changes as described above. AAAHC will determine whether the current accreditation term will be maintained and will establish any such conditions. Relocations and extensive renovations may be subject to a survey to assess compliance with the Standards and Conditions for Coverage.

Providers and suppliers must notify the designated fee-for-service contractor (FI/MAC) of any change in their Medicare enrollment information.

• Changes of ownership or control must be reported within 30 days to meet CMS requirements.

• Changes in information are submitted within 90 days of such change.

• Changes are reported using the 855b form or PECOS, which is also used to initiate the Medicare enrollment process.

End of Accreditation When an organization’s accreditation term has ended and the organization is not seeking reaccreditation, or it is choosing to withdraw from the accreditation process prior to the expiration of its accreditation, the organization must:

• Destroy all AAAHC Accreditation Certificates.

• Review all internal and public facing information, documents, and correspondence, and internal recorded phone messages, to ensure that anything bearing the AAAHC name and/or logo has been removed or destroyed.

• Review marketing materials: website, print, radio, or television ads, and all other public facing materials to ensure the removal of references to the AAAHC name, logo, and accreditation status.

https://www.aaahc.org/accreditation/accreditation-general-information/organizational-changes/




Compliance with Omnibus Reconciliation Act of 1980 For any health care organization that pays AAAHC $10,000 or more in any 12-month period to comply with Section 952, PL 96-499, the Omnibus Reconciliation Act of 1980, AAAHC hereby stipulates that only those AAAHC records, contracts, documents, or books that are necessary to verify the extent and nature of AAAHC costs will be available for four years after the survey, consultation, or contracted services are completed to the Secretary of the Department of Health and Human Services (DHHS), the Comptroller General of the United States, or any of their duly authorized representatives. This stipulation is provided as a matter of policy by AAAHC in lieu of providing separate contracts for each affected organization. These same conditions will apply to any subcontracts AAAHC has with related organizations if such payments amount to $10,000 or more in any 12-month period. This policy applies to all contracts, surveys, and AAAHC records as of December 5, 1980, and so long as these regulations remain in force.




California State Requirements The following information is for California, a state that requires formal reporting by accrediting organizations. Please check with your respective State and/or Medical Board for ongoing regulatory updates.

California Outpatient Organizations The following regulatory requirements are applicable to outpatient surgery settings that meet the definitions below. During the onsite survey, AAAHC surveyors will determine compliance with the requirements that follow. This overview of applicable laws is not intended to be a complete listing of all laws relevant to California Outpatient Settings.

Definitions Health and Safety Code 1248(b)(1) “Outpatient setting” means any facility, clinic, unlicensed clinic, center, office, or other setting that is not part of a general acute care facility, as defined in Section 1250, and where anesthesia, except local anesthesia or peripheral nerve blocks, or both, is used in compliance with the community standard of practice, in doses that, when administered, have the probability of placing a patient at risk for loss of the patient’s life-preserving protective reflexes.

1248(b)(2) “Outpatient setting” also means facilities that offer in vitro fertilization, as defined in subdivision (b) of Section 1374.55.

1248(b)(3) “Outpatient setting” does not include, among other settings, any setting where anxiolytics and analgesics are administered, when done so in compliance with the community standard of practice, in doses that do not have the probability of placing the patient at risk for loss of the patient’s life-preserving protective reflexes.

1248(c) “Accreditation agency” means a public or private organization that is approved to issue certificates of accreditation to outpatient settings by the board pursuant to Sections 1248.15 and 1248.4.

State Mandated Outpatient Setting Accreditation California Business and Professions Code, Section 2216

“On or after July 1, 1996, no physician and surgeon shall perform procedures in an outpatient setting using anesthesia, except local anesthesia or peripheral nerve blocks, or both, complying with the community standard of practice, in doses that, when administered, have the probability of placing a patient at risk for loss of the patient’s life-preserving protective reflexes, unless the setting is specified in Section 1248.1 of the Health and Safety Codes. Outpatient settings where anxiolytics and analgesics are administered are excluded when administered, in compliance with the community standard of practice, in doses that do not

have the probability of placing the patient at risk for loss of the patient’s life-preserving protective reflexes.”

In accordance with the law, the Medical Board of California adopted standards for approval of accreditation agencies to perform the accreditation of outpatient settings. In 2013, AAAHC received re-approval from the Medical Board of California as a recognized accrediting organization.

According to Health and Safety Code, Section 1248.3.(a), certificates of accreditation issued to outpatient settings by an accreditation organization shall be valid for not more than three years.

Accredited organizations reported for compliance with Section 1248 of the Health and Safety Codes may not have an accreditation term that exceeds 36 months. Therefore, such organizations are required to submit their application for reaccreditation at least six months prior to their accreditation expiration date.

California Health and Safety Code, Section 1248, was amended effective January 1, 2012 to including, but not limited to:

• Outpatient settings that have multiple service locations shall have all of the sites inspected.

• The accrediting organization shall conduct a reasonable investigation of the prior history of the outpatient setting, including all licensed physicians and surgeons who have an ownership interest, to determine whether any adverse accreditation decisions have been rendered against them.

• Any outpatient setting that has been denied accreditation shall disclose the accreditation report to any other accrediting organization to which it submits an application. The new accrediting organization shall ensure that all deficiencies have been corrected.

• During the allotted time to correct the deficiencies, the plan of correction, which includes the deficiencies, shall be conspicuously posted by the outpatient setting in a location accessible to public view. Within 10 days after the adoption of the plan of correction, the accrediting organization shall send a list of deficiencies and the corrective action to be taken to the Medical Board of California.




• All final survey records, which include the survey report, list of deficiencies, plans of correction or plan for improvements and correction, and corrective action completed, shall be public records open to public inspection.

• The Medical Board must obtain and maintain the list for all accredited outpatient settings, and must notify the public by placing the information on its website, http://mbc.ca.gov, whether the setting is accredited or the setting’s accreditation has been revoked, suspended, or placed on probation by the accreditation organization.

Adverse event reporting Business and Professions Code 2216.3: As of January 1, 2014, an accredited outpatient surgery setting is required to report adverse events, as defined in HSC Section 1279.1 to the Medical Board of California no later than five days after the adverse event has been detected, or, if that event is an ongoing urgent or emergent threat to the welfare, health, or safety of patients, personnel, or visitors, no later than 24 hours after the adverse event has been detected.

https://www.cdph.ca.gov/Programs/CHCQ/LCP/Pages/AFL-13-32.aspx The adverse event reporting form can be found at:

https://www.aaahc.org/wp-content/uploads/2018/12/ outpatient_adverse_event_form.pdf

Patient death or transfer reporting Business and Professions Code 2240: A physician or surgeon who performs or supervises a medical procedure outside of a general acute care hospital that results in a death must file a report. The physician must complete the patient death reporting form and send it to the Medical Board of California, Central Complaint Unit.

https://www.mbc.ca.gov/Download/Forms/oss-patient-death.pdf

A physician or surgeon who performs or supervises a scheduled medical procedure that results in a transfer to a hospital or emergency center for medical treatment for a period exceeding 24 hours must send the facility a completed transfer report (Parts A & B) and must send Part B within 15 days of the occurrence to the Office of Statewide Health Planning and Development. Copies of the reporting forms can be obtained at:

https://www.mbc.ca.gov/Download/Forms/ enf-2240b.pdf

or by calling the Medical Board of California at: 916.263.2389.

Patient transfer plan Health and Safety Code 1248.15(d): As of January 1, 2012, in addition to the requirements imposed at 1248.15(c) (See AAAHC Standard 4.I), an outpatient setting must submit its detailed plan, standardized procedures, and protocols to be followed in the event of serious complications or side effects from surgery that would place a patient at high risk for injury or harm or to govern emergent and urgent care situations to AAAHC for approval.

The plan shall include the following minimum provisions in cases where a patient is being transferred to a local accredited or licensed acute care hospital:

i. Notify the individual designated by the patient to be notified in case of an emergency.

ii. Ensure that the mode of transfer is consistent with the patient’s medical condition.

iii. Ensure that all relevant clinical information is documented and accompanies the patient at the time of transfer.

iv. Continue to provide appropriate care to the patient until the transfer is effectuated.

Liability coverage Business and Professions Code 2216.2: Physicians must maintain adequate security by liability insurance or by participation in an interindemnity trust, for claims by patients arising from surgical procedures performed outside of a general acute care hospital.

The law calls for the Medical Board to determine the appropriate amount of required insurance. For purposes of Section 2216.2 of the code, “adequate security” means that a physician has coverage of the type described in Section 2216.2 of the code in the amount of not less than $1 million per incident and not less than $3 million per year. The division shall reevaluate the requirements in this regulation at least every three years.

Posting the AAAHC Accreditation Certificate Health and Safety Code 1248.15(a)(8) and (9): Outpatient surgery settings must post the certificate of accreditation in a location readily visible to patients and staff, and post the name and telephone number of the accrediting agency with instructions on the submission of complaints in a location readily visible to patients and staff. California organizations affected by the law have been instructed to post the following:

https://www.cdph.ca.gov/Programs/CHCQ/LCP/Pages/AFL-13-32.aspx

https://www.aaahc.org/wp-content/uploads/2018/12/outpatient_adverse_event_form.pdf

https://www.mbc.ca.gov/Download/Forms/oss-patient-death.pdf

https://www.mbc.ca.gov/Download/Forms/enf-2240b.pdf




(Name of Organization) is accredited by the Accreditation Association for Ambulatory Health Care, Inc. Any complaints regarding services provided at (Name of Organization) can be directed in writing to:

AAAHC 5250 Old Orchard Road, Suite #200, Skokie, IL 60077 Or by phone: 847.853.6060; Or by fax: 847.853.9028.

Written discharge criteria Health and Safety Code 1248.15(a)(1): Outpatient settings must have written discharge criteria.

Advanced cardiac life support (ACLS) Health and Safety Code 1248.15(b): Outpatient settings must have a minimum of two staff persons on the premises, one of whom is either a licensed physician and surgeon or a licensed health care professional with current certification in advanced cardiac life support (ACLS), as long as a patient is present in the facility and has not been discharged from supervised care.

Inform patients of physician license Business and Professions Code 138: Physicians in California are required to inform their patients that they are licensed by the Medical Board of California, and include the board’s contact information. Complete information and a sample posting notice is available at:

http://www.mbc.ca.gov




Organization’s Right of Appeal Following Denial or Revocation of Accreditation Initial decision and opportunity to submit additional material A proposed recommendation with respect to accreditation by AAAHC is reported to the chief medical executive and the administrative head of the organization. If the proposed recommendation is to deny accreditation or revoke accreditation, such notice will include an explicit statement of the reasons for the decision and generally provide the organization with an opportunity to submit additional material to the AAAHC office within 14 calendar days of receipt of the notice. Unless otherwise indicated by AAAHC, the information provided should be limited to that available at the time of the survey and relative to the Standards identified by AAAHC as less than fully compliant. The information that is provided will be considered by AAAHC in rendering the final accreditation decision.

Final decision subject to right to appeal Any decision to deny or revoke accreditation by AAAHC will be accompanied by an explanation of the reasons for the decision and of the organization’s right to a hearing before an Appeals Hearing Panel. Unless otherwise specified by AAAHC, the panel will be composed of three individuals designated by the President and CEO of AAAHC. The panel will not include: 1) any person who participated in the accreditation decision on behalf of AAAHC; 2) any person who is or ever has been a surveyor of the organization; 3) more than one director from the AAAHC Board of Directors; or 4) any person who is in direct economic competition with or has a bias with respect to the organization seeking accreditation.

The organization’s written request for a hearing to appeal a decision to deny or revoke accreditation must be received within 10 calendar days of the date of the notification, along with a one-time nonrefundable payment of $3500.00 to defray administrative costs incurred in planning and convening the appeals hearing. If the organization fails to request such a hearing on a timely basis, or fails to include payment of $3500.00 at the time of the request, the decision becomes final. The appeal of any decision is governed by AAAHC’s appeal procedures that are in effect at the time of the appeal.

Hearing before the appeals hearing panel A hearing before the Appeals Hearing Panel that is requested by an organization is ordinarily held within 60 calendar days following receipt by AAAHC of its written request and the administrative payment of $3500.00.

In the event that the organization is not available for an appeals hearing within 60 calendar days the organization will be deemed to have waived its right to an appeal unless AAAHC, in its sole discretion, agrees to extend the period for the appeal.

Approximately 14 calendar days before the hearing, the organization is provided notice of the time and place of the hearing, and the name, professional credentials, and location of the panel members. When the decision is based on findings from an onsite survey, the organization will be provided the factual findings included in the survey report. The hearing will be held at the AAAHC office, unless otherwise agreed by the organization and the AAAHC. Panel members may be convened by conference call, and the hearing may proceed with only two of the panel members participating.

At the hearing before the Appeals Hearing Panel, the organization may be accompanied by counsel, make oral presentations, offer testimony, and interview any available surveyor(s) who participated in the survey. At least 14 calendar days before any such hearing, the organization may request, in writing, the presence at the hearing of any such surveyor(s) it wishes to interview. Surveyors who are requested to participate in the hearing may be convened by conference call. If the organization makes any written submission to the Appeals Hearing Panel, the documents should be provided to AAAHC prior to the hearing.

The Appeals Hearing Panel will consider all materials submitted to it on a timely basis. When the accreditation decision is based on findings from a survey, the recommendation of the Appeals Hearing Panel will be based on the organization’s compliance with the AAAHC Standards effective at the time of the survey.

Following the hearing before the Appeals Hearing Panel, the organization will be notified promptly of the panel’s recommendation. If the panel’s recommendation is to uphold the original decision to deny or revoke accreditation, the organization has the right to appeal directly to the AAAHC Board of Directors.

The organization’s written request for appeal to the Board must be received within 10 calendar days of the date of notification of the Appeals Hearing Panel’s recommendation.




If the Appeals Hearing Panel recommends granting accreditation, the organization will be notified of the recommendation, and the Accreditation Committee will be afforded the opportunity to consider the recommendation of the Appeals Hearing Panel at their next regularly scheduled meeting. Following this meeting, the organization will be notified promptly of the accreditation decision. If the decision to deny or revoke accreditation is not modified or reversed by the Accreditation Committee, the organization has 10 calendar days from the date of such notice to appeal directly to the AAAHC Board of Directors.

Appeal to the AAAHC Board of Directors The Board of Directors will consider any appeal at its first regular meeting that is scheduled at least 30 calendar days after receipt of the request for appeal. Members of the Accreditation Committee will not participate in the discussion or the vote by the Board of Directors relative to the accreditation of the organization. Similarly, any AAAHC director who has an interest in the organization, who is a direct economic competitor of the organization, who was a surveyor of the organization, or who was a member of the Appeals Hearing Panel will not participate in the discussion or the vote by the Board of Directors.

The organization may submit, at least 20 calendar days prior to the Board meeting, a written response or comments for review by the Board. The Board will review any such written response and comments submitted, the survey report, and any other materials considered by the Appeals Hearing Panel, and make an accreditation decision that will be final. When the accreditation decision is based on findings from a survey, the Board’s decision will be based on the organization’s compliance with the AAAHC Standards in effect at the time of the survey.

Exceptions with respect to the above appeal procedures AAAHC reserves the right to immediately revoke or deny accreditation before providing notice and an opportunity to submit additional materials or appeal the accreditation decision when, among other things, the organization’s failure to satisfy the AAAHC Standards may result in imminent danger to the health of any individual or individuals. Under such circumstances, AAAHC shall provide subsequent notice and the opportunity to appeal.

AAAHC also reserves the right to deny an organization the right to an appeal if:

1. The organization no longer satisfies the AAAHC Survey Eligibility Criteria.

2. The organization fails to notify AAAHC of a significant change (for a complete list of what constitutes significant changes, see Continuation of accreditation following a significant change on page 17).

3. Any imposition of sanctions, changes in license or qualification status, governmental investigation or proceedings, or violation of state or federal law with respect to the organizations, its officers, administrators, physicians/practitioners, or staff occurs.

Conditions with respect to the appeal process An appeal of an accreditation decision generally does not extend or otherwise affect the term of accreditation. If accreditation is revoked, the organization is not accredited during the appeals process. If an accredited organization seeking reaccreditation is denied, the organization generally remains accredited until the original term of the accreditation expires, which could occur during the appeals process.

Any appeal conducted pursuant to these procedures requires all parties to act in good faith. An organization’s failure to participate in the appeal process in good faith, including, but not limited to, the submission of falsified, incomplete, or inaccurate documents or information for any use during the appeal of an accreditation decision may result, at the discretion of the AAAHC Board of Directors, in termination of the organization’s right to appeal the decision and immediate termination of the appeal.

Any organization that exercises its right to an appeal is obligated to notify AAAHC immediately of any significant change as outlined in Continuation of accreditation following a significant change on page 17.

No organization may exercise its right to an appeal at the same time that it applies for a new AAAHC accreditation survey. Organizations that apply for an accreditation survey should be aware that information about the basis for the previous denial or revocation will be provided to the surveyor.



Core Chapters Standards in the core chapters will be applied to all organizations seeking accreditation

Accreditation Handbook for Medicare Deemed Status, v41


1. Patient Rights and Responsibilities

2. Governance

3. Administration

4. Quality of Care Provided

5. Quality Management and Improvement

6. Clinical Records and Health Information

7. Infection Prevention and Control and Safety

8. Facilities and Environment

Core Chapters

25


Chapter 1

Patient Rights and Responsibilities An accreditable ASC recognizes the basic human rights of patients. In order to meet AAAHC/Medicare Deemed Status requirements, an ASC must meet the Standards of this chapter and the Condition for Coverage (CfC). In addition to complying with the Standards below, the Medicare CfC requires that the ASC inform the patient or the patient’s representative or surrogate of the patient’s rights and must protect and promote the exercise of these rights as set forth in Title 42 CFR 416.50. The ASC must also post the written notice of patient rights in a place or places within the ASC likely to be noticed by patients waiting for treatment or by the patient’s representative or surrogate, if applicable. [§416.50; Q-0219] Note: CMS has indicated that the posting of the written notice, if cited, may be considered a standard level finding at Q-0220.

CMS Tag YES NO

A. Patients are treated with respect, consideration, and dignity.

Elements of compliance

1. The patient has the right to personal privacy. [416.50(f)(1)] Q-0231 o o

2. Patients are provided appropriate privacy: o o

a. At check-in.

b. In evaluation and treatment areas.

3. Interpretation services are available. o o

4. To the degree that it is known, patients are provided with information concerning their diagnosis, evaluation, treatment, and prognosis. When it is medically inadvisable to give such information to a patient, the information is provided to a person designated by the patient or to a legally authorized person.

o o

5. Patients are given the opportunity to participate in decisions involving their health care, except when such participation is contraindicated for medical reasons.

o o

Compliance Rating

Fully Compliant Substantially Compliant

Partially Compliant Minimally Compliant

Non-Compliant

All elements are present

4 of 5 elements are present



1 or no elements are present



Chapter 1: Patient Rights and Responsibilities

CMS Tag

B. The patient has the right to be free from any act of discrimination or reprisal. [416.50(e)(1)(i)]

Q-0227

Compliance Rating



Non-Compliant

Standard is met No rating option Standard is not met

CMS Tag

C. The patient has the right to receive care in a safe setting. [416.50(f)(2)] Q-0232

Compliance Rating



Non-Compliant


CMS Tag

D. The patient has the right to be free from all forms of abuse or harassment. [416.50(f)(3)]

Q-0233

Compliance Rating



Non-Compliant


CMS Tag

E. The ASC must inform the patient or the patient's representative of the patient's rights and must protect and promote the exercise of these rights, as set forth in this section. [416.50]

Q-0219

Compliance Rating



Non-Compliant





CMS Tag YES NO

F. The ASC must also post the written notice of patient rights in a place or places within the ASC likely to be noticed by patients waiting for treatment or by the patient's representative or surrogate, if applicable. [416.50]

Q-0220


1. An ASC must, prior to the start of the surgical procedure, provide the patient, or the patient's representative, or the patient's surrogate with verbal and written notice of the patient's rights in a language and manner that ensures the patient, the representative, or the surrogate understand all of the patient's rights as set forth in Title 42 CFR 416.50. The ASC's notice of rights must include the address and telephone number of the state agency to which patients may report complaints, as well as the website for the Office of the Medicare Beneficiary Ombudsman. [416.50(a)]

Q-0221 o o

2. The ASC must disclose, in accordance with Title 42 CFR Part 420 and, where applicable, provide a list of physicians who have financial interest or ownership in the ASC facility. Disclosure of information must be in writing. [416.50(b)]

Q-0223 o o

Compliance Rating



Non-Compliant


CMS Tag YES NO NA

G. Prior to receiving care, patients are informed of their rights. —


1. Patients and staff are informed of patient rights, including those specified in Standard 1.A.

o o

2. Patients and staff are informed of how to voice grievances regarding treatment or care.

o o

3. Patients and staff are informed of methods for providing feedback, including complaints.

o o

4. Patients and staff are informed of the patient's right to change providers if other qualified providers are available.

o o o

5. Patients and staff are informed about advance directives, as required by prevailing laws and regulations.

o o o




Compliance Rating: if 5 elements apply



Non-Compliant









Non-Compliant


No rating option 2 or 3 of 4 elements are present

No rating option 1 or no elements are present




Non-Compliant


No rating option 2 of 3 elements are present


CMS Tag YES NO NA

H. Prior to receiving care, patients are informed of their responsibilities. —


1. Patients are informed of the responsibility to provide complete and accurate information to the best of their ability about their health, any medications taken, including over-the-counter products and dietary supplements, and any allergies or sensitivities.

o o

2. Patients are informed of the responsibility to follow the agreed-upon treatment plan prescribed by their provider and participate in their care.

o o

3. Patients are informed of the responsibility to provide a responsible adult to provide transportation home and to remain with him/her as directed by the provider or as indicated on discharge instructions.

o o o

4. Patients are informed of the need to accept personal financial responsibility for any charges not covered by insurance.

o o o

5. Patients are informed of the responsibility to behave respectfully toward all health care professionals and staff, as well as other patients and visitors.

o o

References / Notes

• CMS limits what an ASC may charge its patients for the facility fee. An ASC may charge its patients the coinsurance and deductible, if applicable. For Medicare-certified facilities, the responsibility of the patient outlined in 1.H.4 is therefore limited to any applicable deductible and coinsurance.







Non-Compliant









Non-Compliant







Non-Compliant




CMS Tag YES NO NA

I. Information about the organization is available to patients. —


1. Information about services provided by the organization is available. o o

2. Information about provisions for after-hours and emergency care is available. o o

3. Information about fees for services is available. o o o

4. Information about payment policies is available. o o o

5. Information about the credentials of health care professionals is available. o o

6. Information about the absence of malpractice coverage is available. o o o







Non-Compliant



3 or 4 of 6 elements are present






Non-Compliant









Non-Compliant







Non-Compliant




CMS Tag YES NO

J. The patient has the right to be fully informed about a treatment or procedure and the expected outcome before it is performed. [416.50(e)(1)(iii)]

Q-0229


1. If a patient is adjudged incompetent under applicable state laws by a court of proper jurisdiction, the rights of the patient are exercised by the person appointed under state law to act on the patient's behalf. [416.50(e)(2)]

Q-0230 o o

2. If a state court has not adjudged a patient incompetent, any legal representative or surrogate designated by the patient in accordance with state law may exercise the patient's rights to the extent allowed by state law. [416.50(e)(3)]

Q-0230 o o

Compliance Rating



Non-Compliant





CMS Tag YES NO

K. The ASC must comply with the following requirements for advance directives. [416.50(c)]

Q-0224


1. The patient or, as appropriate, the patient's representative is provided written information concerning the ASC's policies on advance directives, including a description of applicable state health and safety laws and, if requested, official State advance directive forms. [416.50(c)(1)]

Q-0224 o o

2. The patient or, as appropriate, the patient's representative is informed of the patient's right to make informed decisions regarding the patient's care. [416.50(c)(2)]

Q-0224 o o

3. Documentation in a prominent part of the patient's current medical record indicates whether or not the individual has executed an advance directive. [416.50(c)(3)]

Q-0224 o o

Compliance Rating



Non-Compliant


CMS Tag

L. The patient has the right to voice grievances regarding treatment or care that is (or fails to be) furnished. [416.50(e)(1)(ii)]

Q-0228

Compliance Rating



Non-Compliant





CMS Tag YES NO

M. The ASC must establish a grievance procedure for documenting the existence, submission, investigation, and disposition of a patient's written or verbal grievance to the ASC. [416.50(d)]

Q-0225


1. All alleged violations/grievances relating, but not limited to, mistreatment, neglect, verbal, mental, sexual, or physical abuse, must be fully documented. [416.50(d)(1)]

Q-0226 o o

2. All allegations must be immediately reported to a person in authority in the ASC. [416.50(d)(2)]

Q-0226 o o

3. Only substantiated allegations must be reported to the state authority or the local authority, or both. [416.50(d)(3)]

Q-0226 o o

4. The grievance process must specify timeframes for review of the grievance and the provision of a response. [416.50(d)(4)]

Q-0225 o o

5. The ASC, in responding to the grievance, must investigate all grievances made by a patient or the patient's representative, or the patient's surrogate, regarding treatment or care that is (or fails to be) furnished. [416.50(d)(5)]

Q-0225 o o

6. The ASC documents how the grievance was addressed, as well as provide the patient, the patient's representative, or the patient's surrogate with written notice of its decision. The decision must contain the name of an ASC contact person, the steps taken to investigate the grievance, the results of the grievance process, and the date the grievance process was completed. [416.50(d)(6)]

Q-0225 o o

Compliance Rating



Non-Compliant


33


Chapter 2

Governance An accreditable organization has a governing body that sets policy and is responsible for the organization. Such an organization meets the following Standards.

Subchapter I – General Requirements: This subchapter describes general requirements for an organization and its governing body.

CMS Tag

A. The ASC must have an agreement with CMS to participate in Medicare as an ASC, and must meet the conditions set forth in Title 42 CFR Part 416, Subparts B - General Conditions and Requirements and C - Specific Conditions for Coverage of Title 42 CFR 416. Participation as an ASC is limited to facilities that: Meet the definition in Title 42 CFR 416.2, AND have in effect an agreement obtained in accordance with Title 421 CFR Part 416, Subpart B - General Conditions and Requirement. [416.25]

Q-0001

Compliance Rating



Non-Compliant


CMS Tag

B. The ASC is a distinct entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization and in which the expected duration of services would not exceed twenty-four (24) hours following admission. [416.2]

Q-0002

Compliance Rating



Non-Compliant




Chapter 2: Governance

CMS Tag

C. The organization is a legally constituted entity, or an organized sub-unit of a legally constituted entity, or is a sole proprietorship in the state(s) in which it is located and provides services, as documented by at least one of the following: articles of organization, articles of incorporation, partnership agreement, operating agreement, legislative or executive act, or bylaws, unless the organization is a sole proprietorship.

—

Compliance Rating



Non-Compliant


CMS Tag

D. The ASC must comply with state licensure requirements. [416.40] Q-0020

Compliance Rating



Non-Compliant


CMS Tag YES NO NA

E. The ASC must have a governing body that assumes full legal responsibility for determining, implementing, and monitoring policies governing the ASC's total operation. [416.41]

Q-0040


1. The governing body has oversight and accountability for the quality assessment and performance improvement (QAPI) program. [416.41]

Q-0040 o o

2. The governing body has oversight and accountability for ensuring that facility policies and programs are administered so as to provide quality health care in a safe environment. [416.41]

Q-0040 o o

3. The governing body has oversight and accountability for developing and maintaining a disaster preparedness plan. [416.41]

Q-0040 o o

4. When services are provided through a contract with an outside resource, the ASC must assure that these services are provided in a safe and effective manner. [416.41(a)]

Q-0041 o o o

Compliance Rating



Non-Compliant





CMS Tag YES NO

F. The governing body is responsible for establishing strategic direction and supporting its accomplishment.

—


1. The governing body determines the mission, goals, and objectives of the organization.

o o

2. The governing body formulates long-range plans in accordance with the mission, goals, and objectives of the organization.

o o

3. The governing body ensures that facilities and personnel are adequate and appropriate to carry out the mission.

o o

Compliance Rating



Non-Compliant




CMS Tag YES NO NA

G. The governing body addresses and is fully and legally responsible, either directly or by appropriate professional delegation, for the operation and performance of the organization.

—


1. The governing body establishes an organizational structure and specifies functional relationships among various components of the organization.

o o

2. The governing body adopts bylaws or similar rules and regulations for the orderly development and management of the organization.

o o

3. The governing body adopts policies and procedures necessary for the orderly conduct of the organization, including the organization's scope of clinical activities.

o o

4. The governing body establishes a system of financial management and accountability appropriate to the organization.

o o

5. The governing body ensures fulfillment of all applicable obligations under prevailing laws and regulations, such as those addressing disabilities, medical privacy, grievances, fraud and abuse, self-referral, anti-trust, reporting to the National Practitioner Data Bank, etc.

o o

6. The governing body oversees compliance with applicable AAAHC Standards. o o

7. The governing body approves products sold to patients. o o o

References / Notes

• For information on the National Practitioner Data Bank, see https://www.npdb.hrsa.gov.







Non-Compliant









Non-Compliant






CMS Tag YES NO NA

H. The governing body addresses and is fully and legally responsible, either directly or by appropriate professional delegation, for the clinical operations and performance of the organization.

—


1. The governing body is responsible for the employment or contracting of health care professionals.

o o

2. The governing body establishes and maintains a policy on the rights and responsibilities of patients.

o o

3. The governing body establishes and maintains a written policy regarding the care of pediatric patients.

o o o

4. The governing body ensures that the quality of care is evaluated and that identified problems are appropriately addressed.

o o

5. The governing body establishes, implements and oversees a risk management program appropriate to the organization that includes review of risk management activities.

o o

6. The governing body establishes, implements and oversees the organization's infection control and safety programs to ensure a safe environment of care.

o o

7. The governing body establishes policies on patient education and continuing education for staff.

o o




Non-Compliant









Non-Compliant









CMS Tag YES NO NA

I. The governing body is responsible for approving and ensuring compliance of all major contracts or arrangements affecting the medical and/or dental care provided under its auspices.

—


1. The governing body approves and ensures compliance with contracts or arrangements for the provision of external services, such as those for radiology, pathology, medical laboratory, and housekeeping services.

o o o

2. The governing body approves and ensures compliance with contracts or arrangements for provision of education to students and postgraduate trainees.

o o o

3. The governing body approves and ensures compliance with contracts or arrangements for the provision of after-hours patient information or telephone triage services, including the review of protocols.

o o o

4. The governing body approves and ensures compliance with contracts or arrangements with The Centers for Medicare & Medicaid Services (CMS) requirements, if the organization participates in the Medicare/Medicaid program.

o o

5. The governing body approves and ensures compliance with contracts or arrangements for activities or services delegated to another entity.

o o o




Non-Compliant









Non-Compliant







Non-Compliant







Non-Compliant



No rating option Neither element is present

Compliance Rating: if 1 element applies



Non-Compliant





CMS Tag YES NO

J. The governing body is responsible for ensuring appropriate communication within and on behalf of the organization.

—


1. The governing body reviews all legal and ethical matters concerning the organization and its staff, and responds appropriately when necessary.

o o

2. The governing body ensures maintenance of effective communication throughout the organization, including ensuring links between quality management and improvement activities and other management functions of the organization.

o o

3. The governing body ensures that marketing, advertising and other statements regarding the competence and capabilities of the organization are not misleading.

o o

4. Evidence is present that policies, procedures, and other information are communicated throughout the organization, as documented in staff meeting minutes, emails, intranet, manuals, and other forms of communication.

o o

5. Evidence is present of organizational procedures to permit appropriate responses to inquiries from entities such as, but not limited to, government agencies, attorneys, consumer advocate groups, and the media.

o o

Compliance Rating



Non-Compliant






CMS Tag

K. The governing body meets at least annually, or more frequently as determined by the governing body, as evidenced by minutes or other records kept as necessary for the orderly conduct of the organization.

—

Compliance Rating



Non-Compliant


CMS Tag

L. Within 15 calendar days of significant organizational, ownership, operational, or quality of care events, the organization notifies AAAHC of the event in writing.

—

References / Notes

• See page 17 for additional information regarding events that must be reported to AAAHC.

Compliance Rating



Non-Compliant





CMS Tag

M. Representation of accreditation to the public accurately reflects the AAAHC-accredited entity.

—

Compliance Rating



Non-Compliant


CMS Tag YES NO

N. Documentation demonstrates at least annual governing body review of AAAHC accreditation requirements.


1. Patients’ rights are reviewed. o o

2. Delegated administrative responsibilities are reviewed. o o

3. Key programs are reviewed: o o

a. The quality management and improvement program is reviewed.

b. The infection prevention and control program is reviewed.

c. The safety program is reviewed.

4. The organization's policies and procedures are reviewed. o o

5. The appointment and reappointment processes are reviewed. o o

6. The scope of procedures performed, and/or services provided, by the organization is reviewed. [416.45(b)]

Q-0122 o o

7. Revisions are made as needed to maintain compliance. o o

Compliance Rating



Non-Compliant






CMS Tag

O. The authority, responsibility and functions of officers and administrators elected, appointed, or employed to carry out governing body directives are clearly defined by the governing body.

—

Compliance Rating



Non-Compliant





Subchapter II – Credentialing and Privileging: This subchapter describes the requirements for credentialing and privileging of health care professionals to provide patient care in an accreditable organization. Organizations may find the Tools section located in the back of this handbook helpful in creating medical staff applications. Credentialing is a three-phase process of assessing and validating the qualifications of an individual to provide services. The objective of credentialing is to establish that the applicant has the specialized professional background that he or she claims and that the position requires. An accreditable organization: 1) establishes minimum training, experience, and other requirements (i.e., credentials) for physicians and other health care professionals; 2) establishes a process to review, assess, and validate an individual’s qualifications, including education, training, experience, certification, licensure, and any other competence-enhancing activities against the organization’s established minimum requirements; and 3) carries out the review, assessment, and validation as outlined in the organization’s description of the process. CMS Tag YES NO

A. The medical staff of the ASC must be accountable to the governing body. [416.45]

Q-0120


1. The governing body has defined specific criteria for the initial appointment and reappointment of medical staff. [416.45(a)]

Q-0121 o o

2. The criteria for initial appointment and reappointment are uniformly applied. o o

3. Applications for clinical privileges are processed according to timeframes specified in bylaws and/or policies.

o o

4. The organization has its own independent process of credentialing and privileging. o o

References / Notes

• Credentials may not be approved, nor privileges granted without further review, solely on the basis that another organization, such as a hospital, approved credentials or granted privileges. Such status at another organization may be included in the governing body’s consideration of the application.

Compliance Rating



Non-Compliant





CMS Tag YES NO NA

B. The governing body has approved processes for credentialing, privileging and reappointment of the medical and/or dental staff.

—


1. A process for credentialing has been approved. o o

2. A process for initial appointment has been approved. o o

3. A process for reappointment has been approved. o o

4. A process for granting clinical privileges has been approved. o o

5. A process for suspending or terminating clinical privileges has been approved. o o

6. A process for the appeal of decisions to suspend or terminate privileges has been approved.

o o

7. Processes for initial appointment, reappointment, and assignment or curtailment of clinical privileges of medical staff members are consistent with state law, if applicable.

o o o




Non-Compliant









Non-Compliant






CMS Tag YES NO NA

C. On a formal application for initial staff privileges, the applicant is required to provide sufficient evidence of training, experience, and current documented competence in performance of the procedures for which privileges are requested.

—


1. Information regarding relevant education, training, and experience is obtained. o o

2. Peer references are obtained to document current competence. o o

3. A current state license is obtained. o o

4. Information is obtained from the National Practitioner Data Bank (NPDB). o o

5. Drug Enforcement Administration (DEA) registration information is obtained, if applicable.

o o o

6. Proof of current medical liability coverage meeting governing body requirements, if any, is obtained.

o o o




References / Notes

• NPDB Continuous Query is an acceptable option for meeting this requirement. For information on the National Practitioner Data Bank, see https://www.npdb.hrsa.gov/.




Non-Compliant









Non-Compliant









Non-Compliant




CMS Tag YES NO

D. The application for initial staff privileges includes written attestation from the applicant addressing other information pertinent to the appointment and privileging processes.

—


1. The application includes professional liability information: o o

a. Claims history.

b. Refusal or cancellation of professional liability coverage.

2. The application includes information on licensure revocation, suspension, voluntary relinquishment, licensure probationary status, or other licensure conditions or limitations.

o o

3. The application includes information about complaints or adverse action reports filed against the applicant with a local, state, or national professional society or licensure board.

o o

4. The application includes information about denial, suspension, limitation, termination, or nonrenewal of professional privileges at any hospital, health plan, medical group, or other health care entity.

o o

5. The application includes information about federal actions or sanctions including DEA and Medicare/Medicaid.

o o

6. The application includes information about conviction of a criminal offense (other than minor traffic violations).

o o

7. The application includes information about current physical, behavioral health, or chemical dependency problems that would interfere with the ability to provide high-quality patient care and professional services.

o o




Compliance Rating



Non-Compliant






CMS Tag YES NO

E. The application for initial staff privileges is accurate and complete. —


1. The application includes a formal statement releasing the organization from any liability in connection with credentialing decisions.

o o

2. The application includes the applicant's attestation to the accuracy and completeness of the application and additional information provided.

o o

3. The application includes the applicant's dated signature. o o

Compliance Rating



Non-Compliant




CMS Tag YES NO

F. Upon receipt of a completed and signed initial application, primary or secondary source verification of credentials is conducted in accordance with the organization's written procedures for credentialing.

—


1. Written procedures are present. o o

2. Credentials are verified using primary and/or secondary sources. o o

References / Notes

• Refer to the Glossary for definitions of primary and secondary source verification. • An accreditable organization may use information provided by a Credentials Verification Organization (CVO) after

proper assessment of the capability and quality of the CVO. A CVO may demonstrate such capability and quality by becoming accredited or certified by a nationally recognized accreditation organization. Accredited organizations are required to conduct primary or secondary source verification of the items listed in Standards 2.II.C.1-6, unless a CVO, or other organization performing primary source verification that is accredited or certified by a nationally recognized body, is used. If the organization uses a CVO or another organization to verify credentials, those entities must perform primary source verification unless such sources do not exist or are impossible to verify.

Compliance Rating



Non-Compliant







CMS Tag YES NO NA

G. The governing body makes appointment and reappointment decisions following review of the applications, or based on recommendations from a delegated entity.

—


1. Applications are reviewed by the governing body or its delegate. o o

2. If the governing body delegates responsibility for reviewing the applications, documentation of the delegation is present.

o o o

3. Peer references and/or peer review activities and results, completed in accordance with AAAHC Standards for peer review, are incorporated into the decision process.

o o

4. Appointment and reappointment decisions made by the governing body are documented.

o o

References / Notes

• In this context, “delegated entity” refers to an internal reviewer or reviewers, e.g., the Medical Director or a Committee that provides recommendations for appointment and reappointment to the governing body. The governing body remains responsible for making appointment and reappointment decisions. Such delegation is not an option for solo providers because Standard 2.II.K.4 requires review by an outside provider.




Non-Compliant







Non-Compliant




CMS Tag YES NO

H. Members of the medical and/or dental staff apply for reappointment every three years, or more frequently if prevailing laws and regulations, or organizational policies, so stipulate. [416.45(b)]

Q-0122


1. Applicants are required to complete a formal reappointment application. o o

2. The reappointment application includes, at minimum: o o

a. Updated personal information.

b. Completed attestation questions found in 2.II.D.1-D.7 and 2.II.E.1-E.2.

c. Dated signature of the applicant.

Compliance Rating



Non-Compliant





CMS Tag

I. Upon receipt of the completed reappointment application, primary or secondary source verification of items listed in Standards 2.II.C.3-C.6 is conducted.

—

Compliance Rating



Non-Compliant


CMS Tag YES NO NA

J. The currency of date-sensitive credentialing and privileging information is monitored and documented on an ongoing basis (at minimum, at expiration, appointment, and re-appointment).

—


1. Ongoing monitoring of licensure is documented. o o

2. Ongoing monitoring of DEA registrations is documented. o o

3. Ongoing monitoring of Board certifications, as applicable, is documented. o o

4. Ongoing monitoring of professional liability insurance (if required) is documented. o o o




Non-Compliant







Non-Compliant







CMS Tag YES NO

K. Solo providers adhere to appropriate credentialing, initial appointment and reappointment procedures.

—


1. The provider is required to complete an application or reapplication, and the documentation identified in Standards 2.II.C, 2.II.D and 2.II.E is present in the credentials file.

o o

2. Documentation in the credentials file includes a list of procedures that may be performed, or services that may be provided, by the provider in the organization/practice setting.

o o

3. To ensure currency, accuracy, and completeness of credentials, the provider's credentials file is reviewed by an outside physician (for a medical practice) or an outside dentist (for a dental practice) at least every three years, or more frequently if state law or organizational policies so stipulate.

o o

4. An outside physician (for medical practices) or dentist (for dental practices) has reviewed the granting of privileges and provided documentation of his/her recommendation.

o o

5. Applications for privileges submitted by other providers are processed in the same manner.

o o

Compliance Rating

Fully Compliant

Substantially Compliant

Partially Compliant

Minimally Compliant

Non-Compliant Not Applicable






Standard does not apply

Privileging is a three-phase process. The objective of privileging is to determine the specific procedures and treatments that a health care professional may perform. An accreditable organization: 1) determines the clinical procedures and treatments that are offered to patients; 2) determines the qualifications related to training and experience that are required to authorize an applicant to obtain each privilege; and 3) establishes a process for evaluating the applicant’s qualifications using appropriate criteria and approving, modifying, or denying any or all requested privileges in a nonarbitrary manner. CMS Tag YES NO

L. Privileges to carry out specified procedures are granted to legally and professionally qualified applicants.


1. Privileges are granted based on: o o

a. The applicant's written request for privileges.

b. Qualifications for the services provided by the organization.

c. Recommendations from qualified medical personnel. [416.45(a)] Q-0121

2. Privileges are granted to the health care professional to practice for a specified period of time.

o o




Compliance Rating



Non-Compliant




CMS Tag YES NO

M. The governing body provides a process for the initial appointment, reappointment, and assignment or curtailment of privileges and practice for allied health care professionals.

—


1. The process is consistent with state law. o o

2. The process includes verification of education, training, experience, and current competence.

o o

3. The process includes primary or secondary source verification of licensure or certification, as applicable.

o o

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant






CMS Tag

N. Surgical procedures must be performed in a safe manner by qualified physicians who have been granted clinical privileges by the governing body of the ASC in accordance with approved policies and procedures of the ASC. [416.42]

Q-0064

Compliance Rating



Non-Compliant





CMS Tag

O. If the ASC assigns patient care responsibilities to practitioners other than physicians, it must have established policies and procedures, approved by the governing body, for overseeing and evaluating their clinical activities. [416.45(c)]

Q-0123

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable



Subchapter III – Peer Review: An accreditable organization maintains an active and organized process for peer review that is integrated into the quality management and improvement program. Accredited organizations may determine which health care professionals can peer review each other, within the following guidelines: 1) differently licensed practitioners reviewing each other must be privileged to provide similar services to similar patients; and 2) prevailing laws must permit peer review by differently licensed practitioners. CMS Tag

A. Each physician, dentist or health care professional is reviewed by at least one similarly privileged and/or similarly licensed peer.

—

Compliance Rating



Non-Compliant


CMS Tag

B. In organizations with solo practitioners, an outside peer provides peer review. —

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable






CMS Tag YES NO

C. Privileged health care professionals participate in the development and application of peer review criteria.

—


1. Privileged health care professionals participate in the development and application of the peer review criteria used to evaluate the care they provide.

o o

2. Clinical care is selected for review on an ongoing basis. o o

3. The selection process for care to be reviewed applies to all similarly privileged health care professionals.

o o

4. All clinical incidents are reviewed in accordance with the organization's peer review policies and procedures.

o o

5. All privileged health care professionals are reviewed at least annually by a peer or supervising health care professional.

o o

References / Notes

• Examples of peer review criteria include but are not limited to date of care; compliance with disease management guidelines; following treatment protocols; complications during surgery; post-operative infections; wrong-site surgery.

Compliance Rating



Non-Compliant






CMS Tag YES NO

D. Ongoing monitoring of important aspects of the care provided by physicians, dentists, and other health care professionals is conducted.

—


1. Data are collected in an ongoing manner. o o

2. The data are periodically evaluated to identify trends or occurrences that affect patient outcomes.

o o

3. The data are used to establish internal benchmarks against which performance is compared to identify areas in which improvement is needed.

o o

Compliance Rating



Non-Compliant







CMS Tag

E. The results of peer review activities are reported to the governing body. —

Compliance Rating



Non-Compliant


CMS Tag

F. The results of peer review are used as part of the process for granting continuation of clinical privileges, as described in Chapter 2.II.

—

Compliance Rating



Non-Compliant


CMS Tag YES NO

G. Ongoing professional development and the improvement of staff performance are supported.

—


1. Convenient access to reliable, up-to-date information pertinent to the organization's clinical, educational, administrative, and research services is provided.

o o

2. As demonstrated in the organization's policies or procedures, health care professionals are encouraged to participate in internal or external educational programs and activities, consistent with the organization's mission, goals, and objectives.

o o

Compliance Rating



Non-Compliant




51


Chapter 3

Administration An accreditable organization is administered in a manner that ensures the provision of high-quality health services and that fulfills the organization’s mission, goals, and objectives. Organizations may find it helpful to use the Personnel Records Worksheet, found in the Tools section, to evaluate compliance with some Standards found in this chapter.

CMS Tag YES NO

A. Administrative policies, procedures, and controls adopted by the governing body are implemented to ensure the orderly and efficient management of the organization.

—


1. All policies adopted by the governing body are appropriate for the organization given the services provided and the patients served.

o o

2. As evidenced by the personnel files, all staff employed possess at least the minimum qualifications, experience, competencies, and licensure and/or certification required for their positions.

o o

3. Written job descriptions define and delineate functional responsibilities, authority, and qualifications including licensure and/or certification.

o o

4. Written policies and procedures, as well as other documentation such as (but not limited to) meeting minutes and educational materials, indicate that all reasonable steps are taken to comply with applicable laws and regulations.

o o

5. Evidence is present that official organizational documents such as governing body meeting minutes, corporate organizational documents, bylaws, and other similar records are properly filed, secured, and safeguarded.

o o

Compliance Rating



Non-Compliant








Chapter 3: Administration

CMS Tag YES NO NA

B. Fiscal controls are in place to protect the assets of the organization. —


1. Appropriate and adequate policies and procedures are in place to provide accounting controls over assets, liabilities, revenues, and expenses.

o o

2. Written policies and procedures are in place for controlling accounts receivable and accounts payable.

o o

3. Written policies and procedures are in place to control cash payments and credit arrangements.

o o

4. Written policies and procedures are in place to manage unpaid accounts and accounts being considered for transfer to a collection agency.

o o o

5. Written policies and procedures are in place to manage the purchase, receipt, distribution, maintenance, and security of supplies, equipment, and facilities.

o o




Non-Compliant









Non-Compliant




CMS Tag YES NO NA

C. Written personnel policies are established and implemented to facilitate attainment of the mission, goals, and objectives of the organization.

—


1. Written policies specify privileges and responsibilities of employment, including compliance with an adverse incident reporting system, as described in Standards 5.II.C.1 and 5.II.C.2.

o o

2. Written policies require periodic appraisal of each person's job performance, including current competence.

o o

3. Written policies describe incentives and rewards, if any exist. o o o

4. Written policies are made known to employees at the time of employment. o o

5. Written policies comply with prevailing laws and regulations regarding verification of eligibility for employment (I-9 form), and visas as required.

o o

6. Written policies define the status of students and postgraduate trainees, if present, in the organization.

o o o







Non-Compliant









Non-Compliant









Non-Compliant




CMS Tag YES NO

D. Orientation and training addressing safety and privacy are provided. —


1. Orientation and training address the fire safety and the disaster preparedness plan. o o

2. Orientation and training address the use of emergency, safety and fire extinguishing equipment.

o o

3. Orientation and training address the infection prevention and control program, including bloodborne pathogen and other training required by OSHA.

o o

4. Orientation and training address the safety program, including exposure control training and sharps injury prevention.

o o

5. Orientation and training address the risk management program, including training in the reporting of adverse incidents.

o o

6. Orientation and training address confidentiality and privacy (e.g., HIPAA, FERPA). o o

Compliance Rating



Non-Compliant









CMS Tag YES NO

E. Orientation and training according to position description are provided to all staff.

—


1. Documented orientation and training are completed within 30 days of employment. o o

2. The training described in Standard 3.D is provided annually thereafter. o o

3. The training described in Standard 3.D is provided when there is an identified need. o o

4. The delivery of all training is documented. o o

Compliance Rating



Non-Compliant




CMS Tag YES NO

F. Patient satisfaction with services and facilities provided is periodically assessed.

—


1. Patient satisfaction surveys are conducted on an ongoing basis. o o

2. Survey results are analyzed on an ongoing basis. o o

3. The governing body reviews the survey results. o o

4. Corrective actions are taken as needed. o o

Compliance Rating



Non-Compliant







CMS Tag YES NO

G. The nursing services of the ASC must be directed and staffed to assure that the nursing needs of all patients are met. [416.46]

Q-0140


1. Nursing services of the Ambulatory Surgery Center is directed under the leadership of a Registered Nurse. [416.46]

Q-0140 o o

2. The ASC must have documentation that it has designated a Registered Nurse to direct nursing services. [416.46]

Q-0140 o o

Compliance Rating



Non-Compliant


CMS Tag YES NO

H. Patient care responsibilities must be delineated for all nursing service personnel. [416.46(a)]

Q-0141


1. The assignments must be in writing. [416.46(a)] Q-0141 o o

2. Nursing services must be provided in accordance with recognized standards of practice. [416.46(a)]

Q-0141 o o

3. There must be a registered nurse available for emergency treatment whenever there is a patient in the ASC. [416.46(a)]

Q-0141 o o

Compliance Rating



Non-Compliant





57


Chapter 4

Quality of Care Provided An accreditable organization provides high-quality health care services in accordance with the principles of professional practice and ethical conduct, and with concern for the costs of care and for improving the community’s health status. Such an organization meets the following Standards.

CMS Tag

A. All health care professionals have the necessary and appropriate training and skills to deliver the services provided by the organization, as verified by review of credentials and/or personnel files.

—

Compliance Rating



Non-Compliant


CMS Tag

B. Health care professionals practice their professions in accordance with standards of care and prevailing laws and regulations.

—

Compliance Rating



Non-Compliant


CMS Tag YES NO

C. All personnel assisting in the provision of health care services are appropriately qualified and supervised and are available in sufficient numbers for the care provided.

—


1. Evidence of the following is present: o o

a. Such personnel are appropriately qualified.

b. Such personnel are appropriately supervised.

2. Interviews and observation confirm that such personnel are available in sufficient numbers for the care provided.

o o



Chapter 4: Quality of Care Provided

Compliance Rating



Non-Compliant




CMS Tag YES NO

D. The organization has policies and procedures for identifying, storing, and transporting laboratory specimens and biological products.

—


1. Logging and tracking procedures ensure that results for each specimen are obtained. o o

2. Results for each specimen are reported to the ordering health care professional in a timely manner.

o o

3. Biological products are handled, stored and transported in accordance with manufacturer's instructions and/or regulatory requirements, as applicable.

o o

References / Notes

• For a definition of biological products, see https://www.fda.gov/files/drugs/published/Biological-Product-Definitions.pdf.

Compliance Rating



Non-Compliant




CMS Tag YES NO

E. High-quality health care is provided. —


1. Health care provided is consistent with the standard of care. o o

2. Appropriate and timely diagnoses are made based on findings of the current history and physical examination.

o o

3. Medication reconciliation is performed. o o

4. Treatment provided is consistent with clinical impression or working diagnosis. o o

5. Appropriate and timely consultation and referrals are made. o o

6. When clinically indicated, patients are contacted as quickly as possible for follow-up regarding significant problems and/or abnormal findings.

o o

7. Continuity of care and patient follow-up occurs. o o

Compliance Rating



Non-Compliant









CMS Tag YES NO

F. Patients are educated regarding their condition or illness. —


1. Patients are educated regarding the diagnosis and treatment of their condition or illness.

o o

2. Patients are educated regarding appropriate preventive measures. o o

References / Notes

• In surgical settings, education may include preventive measures such as, for example, avoiding post-operative infections, venous thromboembolism, and/or pulmonary embolism.

Compliance Rating



Non-Compliant




CMS Tag YES NO

G. When the need arises, the organization assists patients with the transfer of their care from one health care professional to another.

—


1. Adequate specialty consultation services are available by prior arrangement. o o

2. Referral to another health care professional is clearly outlined to the patient and arranged with the accepting health care professional.

o o

Compliance Rating



Non-Compliant







CMS Tag

H. One of the following is in place in the event of an emergency or unplanned outcome for which hospitalization is indicated to evaluate and stabilize the patient: • A written transfer agreement for transferring patients to a nearby hospital. • A written policy of only credentialing physicians who have admitting

privileges at a nearby hospital. • A written agreement with a physician or provider group with admitting

privileges at a nearby hospital.

—

Compliance Rating



Non-Compliant


CMS Tag

I. The ASC must have an effective procedure for the immediate transfer, to a hospital, of patients requiring emergency medical care beyond the capabilities of the ASC. [416.41(b)(1)]

Q-0042

Compliance Rating



Non-Compliant


CMS Tag

J. This hospital must be a local, Medicare participating hospital or a local, nonparticipating hospital that meets the requirements for payment for emergency services under Title 42 CFR 482.2. [416.41(b)(2)]

Q-0042

Compliance Rating



Non-Compliant


CMS Tag

K. The ASC must periodically provide the local hospital with written notice of its operations and patient population served. [416.41(b)(3)]

Q-0042

Compliance Rating



Non-Compliant


61


Chapter 5

Quality Management and Improvement In striving to improve the quality of care and to promote more effective and efficient use of facilities and services, an accreditable organization maintains a quality management and improvement program that links peer review, quality improvement activities, infection prevention and safety, and risk management in an organized, systematic way. Organizations may also find it useful to refer to Developing Meaningful Quality Improvement Studies in the Tools section of this Handbook. Note: The intent of this chapter is that administrative and clinical personnel are involved in the quality management and improvement activities of the organization.

Subchapter I – Quality Improvement Program: An accreditable organization maintains an active, integrated, organized, ongoing, data-driven, and peer-based quality improvement (QI) program that meets the following Standards.

CMS Tag YES NO

A. The ASC must develop, implement and maintain an ongoing, data-driven quality assessment and performance improvement (QAPI) program. [416.43]

Q-0080


1. The program must include, but not be limited to, an ongoing program that demonstrates measurable improvement in patient health outcomes, and improves patient safety by using quality indicators or performance measures associated with improved health outcomes and by the identification and reduction of medical errors. [416.43(a)(1)]

Q-0081 o o

2. The ASC must measure, analyze, and track quality indicators, adverse patient events, infection control and other aspects of performance that includes care and services furnished in the ASC. [416.43(a)(2)]

Q-0081 o o

3. The ASC must set priorities for its performance improvement activities. [416.43(c)(1)] Q-0081 o o

4. Priorities focus on high risk, high volume, and problem-prone areas. [416.43(c)(1)(i)] Q-0081 o o

5. Priorities consider incidence, prevalence and severity of problems in those areas. [416.43(c)(1)(ii)]

Q-0081 o o

6. Priorities affect health outcomes, patient safety, and quality of care. [416.43(c)(1)(iii)] Q-0081 o o

Compliance Rating



Non-Compliant




Chapter 5: Quality Management and Improvement

CMS Tag YES NO

B. The organization has a written quality improvement program. —


1. The program addresses the full scope of the organization's health care delivery services and describes how these services are assessed for quality.

o o

2. The specific committee(s) or individual(s) responsible for development, implementation, and oversight of the program are identified.

o o

3. The program includes participation by health care professionals, one or more of whom is a physician or dentist.

o o

4. The purpose of the program and specific objectives to be achieved are identified. o o

5. The program describes the ongoing data collection processes used to measure quality and identify quality-related problems or concerns (see Standard 5.I.D).

o o

6. The program describes how the organization integrates quality improvement activities, peer review, and the risk management and infection prevention and control programs.

o o

7. The program is evaluated at least annually for effectiveness and to determine if the program's purposes and objectives continue to be met.

o o

References / Notes

• “Full scope” includes clinical, administrative, and cost-of-care performance issues, as well as actual patient outcomes, i.e., results of care, including safety of patients.

Compliance Rating



Non-Compliant






CMS Tag YES NO

C. The quality improvement program includes processes to ensure communication of the results of quality improvement activities.

—


1. The program includes processes to ensure that the results of quality improvement activities are reported to the governing body.

o o

2. The program includes processes to ensure that the results of quality improvement activities are reported throughout the organization, as appropriate.

o o

3. The program includes processes to ensure that the results of the annual program evaluation are reported to the governing body.

o o

4. The program includes processes to ensure that the results of the annual program evaluation are reported throughout the organization, as appropriate.

o o

Compliance Rating



Non-Compliant







CMS Tag YES NO

D. Ongoing data collection processes are in place to measure quality and to identify quality-related problems or concerns.

—


1. Processes include analysis of the results of peer review activities. o o

2. Periodic audits of critical processes are conducted, as appropriate for the services provided. (See "audit" in the Glossary.)

o o

3. Ongoing monitoring of important processes and outcomes of care is conducted, as appropriate for the services provided. (See "quality monitoring" in the Glossary.)

o o

4. The organization's performance is compared to internal and external benchmarks. o o

5. Processes include methods to systematically collect information from other pertinent sources.

o o

6. The information and data obtained through the data collection processes is evaluated on an ongoing basis to identify the existence of unacceptable variation or results that require improvement.

o o

References / Notes

• Examples of other pertinent sources include, but are not limited to, patient satisfaction surveys, financial data, medical/legal issues, and outcomes data.

Compliance Rating



Non-Compliant






CMS Tag YES NO

E. The governing body must ensure that the QAPI program is implemented. [416.43(e)]

Q-0084


1. The governing body must ensure that the QAPI program is defined, implemented, and maintained by the ASC. [416.43(e)(1)]

Q-0084 o o

2. The governing body must ensure that the QAPI program addresses the ASC’s priorities and that all improvements are evaluated for effectiveness. [416.43(e)(2)]

Q-0084 o o

3. The governing body must ensure that the QAPI program specifies data collection methods, frequency, and details. [416.43(e)(3)]

Q-0084 o o

4. The governing body must ensure that the QAPI program clearly establishes its expectations for safety. [416.43(e)(4)]

Q-0084 o o

5. The governing body must ensure that the QAPI program adequately allocates sufficient staff, time, information systems, and training to implement the program. [416.43(e)(5)]

Q-0084 o o

Compliance Rating



Non-Compliant





CMS Tag YES NO

F. The program must incorporate quality indicator data, including patient care and other relevant data regarding services furnished in the ASC. [416.43(b)(1)]

Q-0082


1. The ASC uses the data collected to monitor the effectiveness and safety of its services, and quality of its care. [416.43(b)(2)(i)]

Q-0082 o o

2. The ASC uses the data collected to identify opportunities that could lead to improvements and changes in its patient care. [416.43(b)(2)(ii)]

Q-0082 o o

3. Performance improvement activities must track adverse patient events, examine their causes, implement improvements, and ensure that improvements are sustained over time. [416.43(c)(2)]

Q-0082 o o

4. The ASC must implement preventive strategies throughout the facility targeting adverse patient events and ensure that all staff are familiar with these strategies. [416.43(c)(3)]

Q-0082 o o

Compliance Rating



Non-Compliant


CMS Tag YES NO

G. The organization demonstrates that continuous improvement is occurring by conducting quality improvement studies when the data collection processes described in Standard 5.I.D indicate that improvement is or may be warranted.

—


1. As evidenced by documentation of quality improvement studies conducted, the studies include the applicable components of the quality improvement process.

o o

2. At least one current quality improvement study demonstrates that improvement occurred and has been sustained.

o o

3. As documented in committee and/or staff meeting minutes, and/or in records of educational activities, the findings of quality improvement activities are communicated:

o o

a. To the governing body.

b. Throughout the organization, as appropriate.

References / Notes

• See “Developing Meaningful Quality Improvement Studies” in the Tools section of the Handbook for the components of the quality improvement process.

• “Current” is defined as within the current accreditation term, or within the last twelve months for initial surveys.

Compliance Rating



Non-Compliant







CMS Tag

H. The number and scope of distinct improvement projects conducted annually must reflect the scope and complexity of the ASC’s services and operations. [416.43(d)(1)]

Q-0083

Compliance Rating



Non-Compliant


CMS Tag

I. The ASC must document the projects that are being conducted. The documentation, at a minimum, must include the reason(s) for implementing the project, and a description of the project’s results. [416.43(d)(2)]

Q-0083

Compliance Rating



Non-Compliant


CMS Tag YES NO

J. The organization participates in external benchmarking activities that compare key performance measures with other similar organizations, with recognized best practices, and/or with national or professional targets or goals.

—


1. External benchmarking activities include the selection and use of performance measures that are appropriate for improving the processes or outcomes of care relevant to the patients served.

o o

2. External benchmarking activities include collecting and analyzing data related to the selected performance measures on an ongoing basis.

o o

3. External benchmarking activities include comparing internal performance to external benchmarks that are based on valid and reliable local, state, national, or published data.

o o

4. External benchmarking activities include tracking changes in the organization's performance on the selected performance measures.

o o

5. The results of benchmarking activities are incorporated into other quality improvement activities of the organization.

o o

6. As documented in meeting minutes and/or records of educational activities, the results of benchmarking activities are reported:

o o

a. To the governing body.

b. Throughout the organization, as appropriate.




Compliance Rating



Non-Compliant






Subchapter II – Risk Management: An accreditable organization develops and maintains a program of risk management appropriate to the organization, designed to protect the life and welfare of the organization’s patients and employees. Such an organization meets the following Standards. CMS Tag YES NO NA

A. The risk management program includes written policies. —


1. The policies include methods by which a patient may be dismissed from care or refused care.

o o

2. The policies include methods for managing a situation in which a health care professional becomes incapacitated during a medical or surgical procedure.

o o

3. The policies include methods of addressing a situation involving an impaired health care professional.

o o

4. The policies require documentation of responsibility for coverage after normal working hours.

o o

5. The policies require documentation of clinical advice provided after normal working hours.

o o o

6. The policies define restrictions on observers in patient care areas. o o

7. The policies include requirements for evidence of patient consent for all persons permitted in patient care areas who are not authorized staff.

o o

References / Notes

• Examples of unauthorized persons include students, visiting physicians, health care industry representatives, surveyors, maintenance workers, vendors, etc.




Non-Compliant









Non-Compliant









CMS Tag YES NO NA

B. The risk management policies address ongoing processes regarding patient safety and other important issues.

—


1. Policies address encouraging the reporting of near-miss events. o o

2. Policies address the communication of reportable events as required by law and regulation.

o o

3. Policies address the periodic review of all litigation involving the organization and its staff and health care professionals.

o o

4. Policies address the ongoing review of patient complaints and grievances and includes defined response times, as required by law and regulation.

o o

5. Policies address the documentation of timely notification to the professional liability insurance carrier, in accordance with organization or carrier policy, when adverse or reportable events occur.

o o o

6. Policies address the periodic review of clinical records and clinical record policies. o o

7. Policies address other state or federal risk management requirements. o o o




Non-Compliant









Non-Compliant









Non-Compliant









CMS Tag YES NO

C. The organization's risk management program and/or policies define incidents and adverse incidents.

—


1. The definition of an incident includes any clinical or non-clinical occurrence that is not consistent with the routine care or operation of the organization. Incidents may involve patients, visitors, employees, and medical or dental staff members.

o o

2. The definition of an adverse incident includes: o o

a. An unexpected occurrence during a health care encounter involving patient death or serious physical or psychological injury or illness, including loss of limb or function, not related to the natural course of the patient's illness or underlying condition.

b. Any process variation for which a recurrence carries a significant chance of a serious adverse outcome.

c. Events such as actual breaches in medical care, administrative procedures, or other events resulting in an outcome that is not associated with the standard of care or acceptable risks associated with the provision of care and service for a patient.

d. All events involving reactions to drugs and materials.

e. Circumstances or events that could have resulted in an adverse event (i.e., near-miss events).

Compliance Rating



Non-Compliant




CMS Tag YES NO

D. Incidents and adverse incidents are reviewed and corrective actions are taken as needed.

—


1. All incidents are reviewed. o o

2. When appropriate, incidents are acted upon. o o

3. All adverse incidents are analyzed to identify the basic or causal factors underlying the incident and potential improvements in processes or systems, if any exist, to reduce the likelihood of such incidents in the future.

o o

4. Improvements that reduce the likelihood of future adverse incidents are implemented, when indicated.

o o

Compliance Rating



Non-Compliant




69


Chapter 6

Clinical Records and Health Information An accreditable organization maintains electronic and/or paper clinical records and a health information system. Such an organization meets the following Standards. The Clinical Records Worksheet, found in the Tools section, may be useful in assessing your organization’s compliance with Chapter 6 Standards.

CMS Tag

A. The ASC must maintain complete, comprehensive, and accurate medical records to ensure adequate patient care. [416.47]

Q-0160

Compliance Rating



Non-Compliant


CMS Tag YES NO

B. The ASC must develop and maintain a system for the proper collection, storage, and use of patient records. [416.47(a)]

Q-0161


1. A designated person is in charge of clinical records. o o

2. A designated person is in charge of the health information system. o o

3. The system includes measures to ensure adherence to written policies and procedures.

o o

4. The system is monitored on a regular basis. o o

Compliance Rating



Non-Compliant




Chapter 6: Clinical Records and Health Information

CMS Tag YES NO

C. Written policies for clinical records are present. —


1. The policies address the security of information, including accountability for editing, deletion, and access of clinical record content.

o o

2. The policies address the release of patient records. o o

3. The policies address the protection of records from damage or loss, including back-up systems for electronic records.

o o

4. The policies address methods of deterring unauthorized access to clinical records. o o

5. The policies ensure timely access to individual records. o o

6. The policies address the retention of active records. o o

7. The policies address the retirement of inactive records. o o

Compliance Rating



Non-Compliant






CMS Tag YES NO

D. Clinical records are maintained in a manner that facilitates the provision of safe care.

—


1. Except when otherwise required by law, the content and format of clinical records, including the sequence of information, are organized in a consistent manner.

o o

2. Clinical record entries are legible, including items that are scanned into an electronic record.

o o

3. Clinical record entries are easily accessible within the record by authorized personnel.

o o

4. All clinical information relevant to a patient is readily available to authorized personnel any time the organization is open to patients.

o o

5. Patients are given the opportunity to approve or refuse release of records, except when release is permitted or required by law.

o o

Compliance Rating



Non-Compliant









CMS Tag

E. The ASC must comply with the Department’s rules for the privacy and security of individually identifiable health information, as specified at 45 CFR Parts 160 and 164. [416.50(g)]

Q-0234

References / Notes

• Deficiencies cited at Standards 6.D and/or 6.F may indicate that a deficiency at Standard 6.E is appropriate.

Compliance Rating



Non-Compliant


CMS Tag YES NO

F. Except when otherwise required by law, any record that contains clinical, social, financial, or other data about a patient is treated as strictly confidential.

—


1. Written policies require strict confidentiality of information in the clinical record. o o

2. Interviews and observation confirm that patient data is handled confidentially. o o

Compliance Rating



Non-Compliant




CMS Tag YES NO NA

G. An individual clinical record is maintained for each person receiving care. Every record must be accurate, legible, and promptly completed. Medical records include at least the following items. [416.47(b)]

Q-0162


1. Each record includes patient identification, including name and date of birth. [416.47(b)(1)]

Q-0162 o o

2. Each record includes an identification number, if used in the organization's system. o o o

3. Each record includes patient gender. o o

4. Each record includes a responsible party. o o

5. Each record includes entries related to anesthesia administration. [416.47(b)(6)] Q-0162 o o

6. Each record includes documentation of properly executed informed consent. [416.47(b)(7)]

Q-0162 o o

Compliance Rating



Non-Compliant





CMS Tag YES NO

H. Clinical record entries are consistent across records.


1. Entries include date (and department, if departmentalized). o o

2. Entries include significant medical history and results of physical examination. [416.47(b)(2)]

Q-0162 o o

3. Entries include pre-operative diagnostic studies, entered into the medical record before surgery, if performed. [416.47(b)(3)]

Q-0162 o o

4. Clinical records include findings and techniques of the operation including a pathologist’s report on all tissues removed during surgery, except those exempted by the governing body. [416.47(b)(4)]

Q-0162 o o

5. Entries consistently include any changes in prescription and non-prescription medication with name and dosage, when available.

o o

6. Entries consistently include discharge diagnosis or impression, and disposition, recommendations and instructions given to the patient. [416.47(b)(8)]

Q-0162 o o

7. Entries consistently include signature of, or authentication by, the health care professional on the clinical record entries.

o o

Compliance Rating



Non-Compliant






CMS Tag YES NO

I. The presence or absence of allergies, sensitivities and other reactions to drugs, materials, food, and environmental factors is recorded in a prominent and consistently defined location in all clinical records. [416.47(b)(5)]

Q-0162


1. Clinical records document that patients are asked to provide information about allergies and sensitivities at each encounter.

o o

2. Clinical records indicate that patients are asked to provide information about other reactions at each encounter.

o o

3. Information about allergies, sensitivities and reactions is recorded in a prominent and consistently defined location in all clinical records. [416.47(b)(5)]

Q-0162 o o

4. Such information is verified at each patient encounter and updated when changes are reported.

o o

Compliance Rating



Non-Compliant





CMS Tag YES NO

J. Reports, histories and physicals, progress notes, and other patient information such as laboratory reports, x-ray readings, operative reports, and consultations, are reviewed and incorporated into the record, as required by the organization's policies.

—


1. There is evidence that such items were reviewed in accordance with policy prior to incorporation into the record.

o o

2. Such items have been incorporated into the clinical record. o o

3. The date of entry is documented in the record. o o

Compliance Rating



Non-Compliant




CMS Tag

K. Clinical records document discussions with the patient concerning the necessity, appropriateness, and risks of the proposed care, surgery, or procedure, as well as discussions of treatment alternatives, as applicable.

—

Compliance Rating



Non-Compliant


CMS Tag

L. Any notation in a patient's clinical record indicating diagnostic or therapeutic intervention as part of clinical research is clearly contrasted with entries regarding the provision of non-research related care.

—

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable






CMS Tag YES NO NA

M. Clinical records demonstrate that the organization ensures continuity of care for its patients.

—


1. Clinical records include documentation regarding missed and canceled appointments, if any.

o o

2. Clinical records include documentation of medical advice given to a patient by text, e-mail, or telephone, including medical advice provided after-hours, if any.

o o

3. If a patient has had three or more visits/admissions, or if a clinical record is complex and lengthy, a summary of past and current diagnoses or problems, including past procedures, is present in the record to facilitate the continuity of care.

o o o




Non-Compliant







Non-Compliant




CMS Tag YES NO NA

N. If a patient's primary or specialty care provider(s) or health care organization is elsewhere, timely summaries or pertinent records necessary for continuity of patient care are available.

—


1. Summaries or records are obtained from the external provider(s) or organization. o o

2. Summaries or records are incorporated into the clinical record. o o o

3. Summaries or records are provided to the external health care professional as appropriate and in accordance with Standard 6.D.5.

o o

References / Notes

• Surgical organizations may choose to maintain such records in a file other than the clinical record.




Non-Compliant







Non-Compliant




75


Chapter 7

Infection Prevention and Control and Safety An accreditable organization provides health care services while adhering to safe practices for patients, staff, and all others. The organization maintains ongoing programs designed to (1) prevent and control infections and communicable diseases, and (2) provide a safe and sanitary environment of care. Surveyors conducting a Medicare Deemed Status Survey are required by CMS to complete the ASC Infection Control Surveyor Worksheet. AAAHC strongly recommends that ASCs in the Deemed Status Program use this worksheet to perform a pre-survey self-assessment. The document can be accessed at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107_exhibit_351.pdf

Subchapter I — Infection Prevention and Control: An accreditable organization maintains an active and ongoing infection prevention and control program as evidenced by the following characteristics. [416.51 Condition for Coverage — Infection control] The ASC must maintain an infection control program that seeks to minimize infections and communicable diseases.].

CMS Tag YES NO

A. The ASC must maintain a written infection prevention and control program that seeks to minimize infections and communicable diseases. [416.51]

Q-0240


1. The program is approved by the governing body. o o

2. The program is relevant to the organization as demonstrated by a formal, documented infection prevention risk assessment.

o o

3. The infection control and prevention program must include documentation that the ASC’s governing body has considered, selected, and implemented nationally recognized infection control guidelines. [416.51(b)]

Q-0242 o o

4. The infection control program is an integral part of the ASC’s quality improvement program as demonstrated by applicable policies and procedures, and by surveillance and monitoring activities. [416.51(b)(2)]

Q-0244 o o

5. The written infection prevention and control program is in compliance with all applicable state, federal and/or tribal requirements including, but not limited to, OSHA.

o o

6. The program must provide a functional and sanitary environment for the provision of surgical services by adhering to professionally acceptable standards of practice. [416.51(a)]

Q-0241 o o

Compliance Rating



Non-Compliant




Chapter 7: Infection Prevention and Control and Safety

CMS Tag YES NO

B. The ASC maintains an ongoing, written program designed to prevent, control, identify, investigate, and manage infections and communicable diseases. [416.51(b)]

Q-0242


1. The infection control program is responsible for providing a plan of action for preventing, identifying, and managing infections and communicable diseases and for immediately implementing corrective and preventive measures that result in improvement. [416.51(b)(3)]

Q-0245 o o

2. To reduce the risk of health care-acquired infection, the program requires education and active surveillance consistent with:

o o

a. WHO, CDC, or other nationally recognized guidelines for hand hygiene.

b. CDC or other nationally recognized guidelines for safe injection practices.

3. A written policy outlines appropriate hand hygiene using products according to the product manufacturer's instructions for use.

o o

Compliance Rating



Non-Compliant


CMS Tag YES NO

C. The infection control program is under the direction of a designated and qualified professional who has training in infection control. [416.51(b)(1)]

Q-0243


1. The governing body or its designee has assigned a qualified health care professional to direct the program.

o o

2. There is documented evidence that the assigned person: o o

a. Has obtained training in infection prevention and control.

b. Demonstrates current competence in infection prevention and control.

Compliance Rating



Non-Compliant





CMS Tag YES NO NA

D. Safe processes are used for the cleaning, decontamination, high-level disinfection, and sterilization of instruments, equipment, supplies, and implants.

—


1. Sterilization equipment is available, if needed. o o o

2. Internal and external indicators, including biological indicators, are used with items undergoing sterilization.

o o o

3. A written policy addresses the identification and processing of medical equipment and instruments that fail to meet high-level disinfection or sterilization parameters.

o o o

4. Cleaning, decontamination, high-level disinfection, and sterilization processes adhere to:

o o

a. Nationally recognized guidelines.

b. Manufacturer's instructions for use.

c. State and federal guidelines.

5. A written policy is in place for monitoring and documenting the cleaning, decontamination, high-level disinfection, and sterilization of medical equipment, accessories, instruments, and implants.

o o

6. Observation confirms that sterile packs of equipment and instruments are handled and stored to maintain their sterility.

o o




Non-Compliant









Non-Compliant









Non-Compliant







Non-Compliant







CMS Tag YES NO

E. A written sharps injury prevention program is present in the organization. —


1. The program requires disposal of intact needles and syringes into appropriate puncture-resistant sharps containers, in accordance with current state and federal guidelines.

o o

2. The program requires placement of sharps containers in appropriate care areas, secured from tampering.

o o

3. The program requires replacement of sharps containers when the fill line is reached. o o

4. The program requires handling, storage, and disposal of filled sharps containers in accordance with applicable regulations.

o o

Compliance Rating



Non-Compliant




CMS Tag YES NO

F. Safeguards are in place to protect patients and others from cross-infection. —


1. Written policies and procedures require the isolation or immediate transfer of patients with communicable diseases.

o o

2. Written policies and procedure require that public health authorities are notified of reportable conditions.

o o

3. Written policies and procedures require adequate surveillance to minimize the sources and transmission of infections.

o o

4. Written policies identify people authorized to be in patient care areas. o o

Compliance Rating



Non-Compliant







CMS Tag YES NO

G. Resources are sufficient to protect patients and others from cross-infection. —


1. Space is sufficient. o o

2. Equipment is sufficient. o o

3. Supplies are sufficient. o o

4. Personnel are sufficient. o o

Compliance Rating



Non-Compliant




CMS Tag YES NO

H. Written policies address the cleaning of patient treatment and care areas. —


1. Policies address cleaning before use. o o

2. Policies address cleaning between patients. o o

3. Policies address terminal cleaning frequency based upon use of the area. o o

4. Policies address requirements for using cleaning products according to the manufacturer's instructions for use.

o o

Compliance Rating



Non-Compliant







CMS Tag YES NO

I. Medical devices for use with multiple patients are processed between patients according to the manufacturer's instructions or nationally recognized guidelines, whichever are more stringent.

—


1. Policies provide direction for how such devices are processed or cleaned. o o

2. Manufacturer's instructions and/or nationally recognized guidelines are available to appropriate staff.

o o

3. There is documented evidence of training and competency assurance of staff responsible for processing or cleaning these devices.

o o

Compliance Rating



Non-Compliant




Subchapter II – Safety: An accreditable organization adheres to safe practices for patients, staff, and others and meets the following Standards.

CMS Tag YES NO NA

A. A written safety program approved by the governing body addresses the environment of care, the safety of patients, staff, and others, and meets or exceeds local, state, or federal safety requirements.

—


1. The governing body has approved the written safety program. o o

2. The program includes processes for managing identified hazards, potential threats, near misses, and other safety concerns.

o o

3. The program includes processes to reduce and avoid medication errors. o o

4. The program includes practices employed to prevent falls and other physical injuries, and to ensure the accurate and timely reporting of such events.

o o

5. The program includes the consistent use of unique patient identifiers throughout a patient's care.

o o

6. The program includes practices employed to prevent skin and tissue injury from chemicals, cleaning solutions, and other hazardous exposure.

o o

7. The program includes methods of ensuring that food and drink for patient use is stored, prepared, served, and disposed of in compliance with local, state, and federal guidelines.

o o o

References / Notes

• Examples related to element 2 include ergonomic exposures, violence in the workplace, and external physical threats, such as terrorism.







Non-Compliant









Non-Compliant






CMS Tag YES NO

B. The safety program requires performance of a proactive, documented risk assessment before commencing demolition, construction or renovation while the facility is occupied.

—


1. The risk assessment identifies potential risks to occupant health and/or safety. o o

2. The risk assessment identifies actions necessary to eliminate or adequately mitigate such risks.

o o

3. The risk assessment identifies provisions for monitoring and mitigating risks during the process, and for updating or expanding the risk assessment, if necessary, to ensure continued protection of all occupants.

o o

Compliance Rating



Non-Compliant




CMS Tag

C. Documentation demonstrates that the risk assessment was conducted or is underway in accordance with the requirements of the organization's safety program.

—

References / Notes

• For initial surveys, apply the NA rating. May also be rated NA on reaccreditation surveys if none of the types of projects described in Standard 7.II.B have occurred in the last three years, or no such project is anticipated.

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable






CMS Tag YES NO

D. Personnel trained in basic life support (BLS) and the use of cardiac and all other emergency equipment and supplies are present in the facility when patients are present. [416.44(e)]

Q-0110


1. Personnel files include documentation of current BLS training. o o

2. There is documentation of training in the use of cardiac and all other emergency equipment and supplies.

o o

3. A policy requires the presence of trained and currently certified personnel when patients are present.

o o

Compliance Rating



Non-Compliant


CMS Tag YES NO

E. A written policy and process addresses the recall of items including drugs and vaccines, blood and blood products, medical devices, equipment and supplies, and food products.

—


1. The policy addresses sources of recall information (FDA, CDC, manufacturers, and other local, state, or federal sources).

o o

2. The policy addresses how applicable staff members are notified. o o

3. The policy addresses how the organization determines if a recalled product is present or has been given or administered to patients.

o o

4. The policy addresses the response to recalled products. o o

5. The policy addresses the disposition or return of recalled items. o o

6. The policy addresses patient notification, as appropriate. o o

Compliance Rating



Non-Compliant









CMS Tag YES NO

F. All products, including medications, reagents, solutions, and supplies that have a manufacturer's printed expiration date are monitored and disposed of in compliance with facility policy and manufacturers' guidelines.

—


1. A written policy for the monitoring and disposal of products with expiration dates is present.

o o

2. The policy describes the process for ensuring that products with a manufacturer's printed expiration date are monitored for currency.

o o

3. The policy for disposal or return of expired items complies with prevailing laws and regulations, and manufacturer guidelines.

o o

Compliance Rating



Non-Compliant




CMS Tag YES NO

G. A system exists for the proper identification, management, handling, transport, and disposal of hazardous materials and wastes, whether solid, liquid, or gas.

—


1. Hazardous materials and waste are properly labeled. o o

2. Hazardous materials and waste are managed and disposed of in accordance with prevailing laws and regulations.

o o

3. Staff responsible for hazardous waste management and disposal demonstrate knowledge of prevailing laws and regulations.

o o

Compliance Rating



Non-Compliant







CMS Tag YES NO

H. The temperature of items that are frozen, refrigerated, and/or heated is continuously monitored to ensure that the product manufacturer's recommended temperature range is maintained.

—


1. A mechanism is present for continuously measuring the temperature of frozen, refrigerated, and/or heated items.

o o

2. Logs or other documentation demonstrate that temperature monitoring occurs. o o

3. Recommended temperature ranges are readily available to staff performing the monitoring function.

o o

4. Documentation and/or interviews confirm that staff performing the monitoring function have been trained what to do if the temperature falls outside of the recommended range.

o o

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant



No rating option 2 or 3 of 4 elements are

present



CMS Tag

I. A written policy requires documentation of the pre-cleaning, transport, and handling of medical devices intended for external vendor reprocessing, inspection, or repair.

—

Compliance Rating



Non-Compliant


CMS Tag YES NO NA

J. Reprocessing of manufacturer-labeled single-use devices complies with FDA regulation and is limited to devices approved for reprocessing in accordance with FDA 510(k) clearance.

—


1. Documentation demonstrates that reprocessed single-use devices have been approved for reprocessing in accordance with FDA 510(k) clearance.

o o

2. If a third-party reprocessor is used, documentation demonstrates that the reprocessor is FDA-registered.

o o o

3. If reprocessing is conducted in-house, documentation demonstrates that the organization is FDA-registered.

o o o







Non-Compliant




Compliance Rating: if 2 elements apply or Standard does not apply

Fully Compliant


Partially Compliant

Minimally Compliant






CMS Tag

K. If medical devices are provided to patients, instructions to the patients regarding use of the devices are documented.

—

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable



CMS Tag YES NO

L. Prior to use, appropriate education is provided to intended operators of newly acquired devices or products to be used in the care of patients.

—


1. A designated person is responsible for ensuring that clinical education occurs prior to the use of the devices or products.

o o

2. Vendor representatives are not used as the sole source for clinical education. o o

Compliance Rating



Non-Compliant







CMS Tag YES NO

M. Fire prevention and safety are addressed in the written safety program. —


1. Policies and procedures to educate medical staff members, employees, volunteers, and other providers and personnel in fire prevention and fire hazard reduction are followed.

o o

2. The safety program requires that fire safety, fire prevention, and fire drills are included in the surveillance activities of personnel responsible for safety and risk management.

o o

Compliance Rating



Non-Compliant




CMS Tag YES NO

N. Health care workers are protected from biologic hazards, consistent with prevailing laws and regulations and nationally recognized guidelines.

—


1. The governing body has approved and implemented policies that comply with all applicable occupational health and safety regulations for health care workers designed to eliminate and/or minimize exposures.

o o

2. A written exposure control plan is reviewed and updated at least annually, including an evaluation of the availability of safer medical devices and changes in technology.

o o

3. An immunization program offered to all staff includes vaccinations for infectious agents of risk to and patients as indicated by the infection prevention risk assessment.

o o

4. A tuberculosis detection and protection plan is in place and follows requirements of prevailing health authorities. If no such requirements exist, nationally recognized guidelines for tuberculosis detection and prevention in health care are followed.

o o

5. Programs that address other relevant biological hazards as indicated by the infection prevention risk assessment, such as bioterrorism, are provided as needed for safety and health.

o o

Compliance Rating



Non-Compliant









CMS Tag YES NO

O. Procedures addressing bloodborne pathogens are in place. —


1. The procedures include a Hepatitis B vaccination program. o o

2. The procedures include post-exposure evaluation and treatment. o o

3. The procedures include appropriate training in and communication of hazards to health care workers.

o o

4. The procedures include appropriate record keeping and management. o o

Compliance Rating



Non-Compliant




CMS Tag YES NO

P. A program is maintained to assess and reduce risks associated with occupational chemical exposures.

—


1. The program includes a hazard assessment of chemicals used in the workplace, conducted at least annually and as new products are added.

o o

2. The program includes engineering measures to reduce the risk of chemical exposure.

o o

3. The program includes worker training programs, as documented in personnel files, meeting minutes, or in another manner.

o o

Compliance Rating



Non-Compliant







CMS Tag YES NO

Q. Work injuries and illnesses are appropriately documented and investigated with records maintained as applicable.

—


1. Work injury and illness records are documented and maintained in accordance with state and federal reporting requirements and any other insurance requirements.

o o

2. Work injury and illness records detail the issue and any investigation of the occurrence.

o o

3. Work injury and illness health records are maintained in compliance with state and federal confidentiality and security standards (e.g., OSHA).

o o

Compliance Rating



Non-Compliant




89


Chapter 8

Facilities and Environment An accreditable organization provides a functionally safe and sanitary environment for its patients, personnel, and visitors, as demonstrated by meeting the following Standards.

Subchapter I – Facilities.

CMS Tag

A. Documentation demonstrates that the facility complies with applicable building codes and regulations.

—

Compliance Rating



Non-Compliant


References / Notes

• Examples of such documentation include an occupancy permit, a report or letter from a relevant fire authority, and/or a report or letter from the relevant building approval authority.

CMS Tag YES NO

B. The facility is operated in a safe and secure manner. —


1. Written policies addressing safety and security practices are present. o o

2. Observation and/or interviews confirm that security practices are followed. o o

Compliance Rating



Non-Compliant






Chapter 8: Facilities and Environment

CMS Tag YES NO

C. The physical environment supports patient comfort and privacy. —


1. Reception areas and restroom facilities are appropriate for patient and visitor volume. o o

2. Examination rooms, dressing rooms, and reception areas are constructed and maintained to ensure patient privacy during interviews, examinations, treatment, and consultation.

o o

3. Smoking is prohibited within the facility. o o

4. Provisions are made to reasonably accommodate disabled individuals. o o

5. Adequate lighting and ventilation are provided in all areas. o o

6. Observation and interviews confirm that the space allocated for a particular function or service is adequate for the activities performed therein.

o o

Compliance Rating



Non-Compliant






CMS Tag

D. Facilities are clean and properly maintained. —

References / Notes

• Elements of “clean and properly maintained” include but are not limited to: Surfaces are free of dust and visible soil; wall finishes are smooth, uniform and easy to clean; lack of mold and rust in the facility; plumbing, window and door hardware, and HVAC systems are in working order; there is no visible damage or wear on electrical receptacles and light switches.

Compliance Rating



Non-Compliant





CMS Tag

E. There are no visible hazards that might lead to slipping, falling, electrical shock, burns, poisoning, or other trauma.

—

Compliance Rating



Non-Compliant


CMS Tag YES NO

F. The ASC must have a safe and sanitary environment, properly constructed, equipped, and maintained to protect the health and safety of patients. [416.44]

Q-0100


1. The ASC must provide a functional and sanitary environment for the provision of surgical services. [416.44(a)]

Q-0101 o o

2. Each operating room must be designed and equipped so that the types of surgery conducted can be performed in a manner that protects the lives and assures the physical safety of all individuals in the area. [416.44(a)(1)]

Q-0101 o o

3. The ASC must have a separate recovery room and waiting area. [416.44(a)(2)] Q-0102 o o

Compliance Rating



Non-Compliant


CMS Tag

G. Except as otherwise provided in this section, the ASC must meet the provisions applicable to Ambulatory Health Care Occupancies, regardless of the number of patients served, and must proceed in accordance with the Life Safety Code (NFPA 101 and Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4). [416.44(b)(1)]

Q-0104

References / Notes

• 416.44(b)(2) In consideration of a recommendation by the State survey agency or Accrediting Organization or at the discretion of the Secretary, may waive, for periods deemed appropriate, specific provisions of the Life Safety Code, which would result in unreasonable hardship upon an ASC, but only if the waiver will not adversely affect the health and safety of the patients. 416.44(b)(3) The provisions of the Life Safety Code do not apply in a state if CMS finds that a fire and safety code imposed by state law adequately protects patients in an ASC. (1) National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02169, www.nfpa.org, 1.617.770.3000.

i. NFPA 99, Standards for Health Care Facilities Code of the National Fire Protection Association 99, 2012 edition, issued August 11, 2011.

ii. TIA 12-2 to NFPA 99, issued August 11, 2011. iii. TIA 12-3 to NFPA 99, issued August 9, 2012. iv. TIA 12-4 to NFPA 99, issued March 7, 2013. v. TIA 12-5 to NFPA 99, issued August 1, 2013. vi. TIA 12-6 to NFPA 99, issued March 3, 2014.




vii. NFPA 101, Life Safety Code, 2012 edition, issued August 11, 2011. viii. TIA 12-1 to NFPA 101, issued August 11, 2011. ix. TIA 12-2 to NFPA 101, issued October 30, 2012. x. TIA 12-3 to NFPA 101, issued October 22, 2013. xi. TIA 12-4 to NFPA 101, issued October 22, 2013.

Compliance Rating



Non-Compliant


CMS Tag

H. Except as otherwise provided in this section, the ASC must meet the applicable provisions and must proceed in accordance with the 2012 edition of the Health Care Facilities Code (NFPA 99, and Tentative Interim Amendments TIA 12-2, TIA 12-3, TIA 12-4, TIA 12-5 and TIA 12-6). [416.44(c)]

Q-0108

References / Notes

• 416.44(c)(2) If application of the Health Care Facilities Code required under paragraph (c) of this section would result in unreasonable hardship for the ASC, CMS may waive specific provisions of the Health Care Facilities Code, but only if the waiver does not adversely affect the health and safety of patients.

Compliance Rating



Non-Compliant


CMS Tag

I. Beginning July 5, 2017, an ASC must be in compliance with NFPA 101 Life Safety Code Chapter 21.3.2.1, Doors to hazardous areas. [416.44(b)(6)]

Q-0107

Compliance Rating



Non-Compliant


CMS Tag

J. An ASC may place alcohol-based hand rub dispensers in its facility if the dispensers are installed in a manner that adequately protects against inappropriate access. [416.44(b)(4)]

Q-0105

Compliance Rating



Non-Compliant





CMS Tag YES NO NA

K. When a sprinkler system is shut down for more than 10 hours, the ASC must implement one of the following procedures. [416.44(b)(5)]

Q-0106


1. Evacuate the building or portion of the building affected by the system outage until the system is back in service, OR [416.44(b)(5)(i)]

Q-0106 o o o

2. Establish a fire watch until the system is back in service. [416.44(b)(5)(ii)] Q-0106 o o o

Compliance Rating



Non-Compliant


CMS Tag YES NO NA

L. Medical equipment is appropriately maintained. —


1. Written policies and procedures for equipment maintenance are present. o o

2. At minimum, the policies address: o o

a. Standardized use of the equipment.

b. Requirements for periodic calibration according to manufacturer's specifications (if equipment requiring calibration is used).

c. Requirements for periodic testing and preventive maintenance according to manufacturer specifications.

3. Documentation of periodic calibration according to manufacturer's specifications is present (if equipment requiring calibration is used).

o o o

4. Documentation of preventive maintenance according to manufacturer's instructions is present.

o o




Non-Compliant







Non-Compliant







CMS Tag YES NO

M. The ASC medical staff and governing body of the ASC coordinates, develops, and revises ASC policies and procedures to specify the types of emergency equipment required for use in the ASC’s operating room. [416.44(d)]

Q-0109


1. The equipment must be immediately available for use during emergency situations. [416.44(d)(1)]

Q-0109 o o

2. The equipment must be appropriate for the facility's patient population. [416.44(d)(2)] Q-0109 o o

3. The equipment must be maintained by appropriate personnel. [416.44(d)(3)] Q-0109 o o

4. Observation and interviews confirm that the required emergency equipment and supplies are maintained.

o o

5. Emergency equipment and supplies are readily accessible to all areas of each patient care service site.

o o

Compliance Rating



Non-Compliant


CMS Tag YES NO

N. Scenario-based drills of the internal and external emergency and disaster preparedness plan are conducted.

—


1. All drills are scenario-based. o o

2. At least one drill is conducted each calendar quarter. o o

3. One of the quarterly drills is a cardiopulmonary resuscitation (CPR) technique drill, as appropriate to the organization.

o o

4. A written evaluation of each drill is completed. o o

5. Any needed corrections or modifications to the emergency plan are implemented promptly.

o o

Compliance Rating



Non-Compliant









Subchapter II – Emergency Preparedness. CMS Tag YES NO

A. The Ambulatory Surgical Center (ASC) must comply with all applicable Federal, State, and local emergency preparedness requirements. The ASC must establish and maintain an emergency preparedness program that meets the requirements of this section. [416.54]

E-0001


1. The ASC must develop and maintain an emergency preparedness plan that must be reviewed and updated at least annually. [416.54(a)]

E-0004 o o

2. The plan must be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. [416.54(a)(1)]

E-0006 o o

3. The plan must include strategies for addressing emergency events identified by the risk assessment. [416.54(a)(2)]

E-0006 o o

4. The plan must address patient population, including, but not limited to, the type of services the ASC has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans. [416.54(a)(3)]

E-0007 o o

5. The plan must include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation. [416.54(a)(4)]

E-0009 o o

Compliance Rating



Non-Compliant


CMS Tag YES NO

B. The ASC must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and procedures must address the following: [416.54(b)]

E-0013


1. The policies and procedures must address a system to track the location of on-duty staff and sheltered patients in the ASC's care during an emergency. If on-duty staff or sheltered patients are relocated during the emergency, the ASC must document the specific name and location of the receiving facility or other location. [416.54(b)(1)]

E-0018 o o

2. The policies and procedures must address safe evacuation from the ASC, which includes the following: [416.54(b)(2)]

E-0020 o o

a. Consideration of care and treatment needs of evacuees. [416.54(b)(2)(i)] E-0020 o o

b. Staff responsibilities. [416.54(b)(2)(ii)] E-0020 o o

c. Transportation. [416.54(b)(2)(iii)] E-0020 o o

d. Identification of evacuation location(s). [416.54(b)(2)(iv)] E-0020 o o

e. Primary and alternate means of communication with external sources of assistance. [416.54(b)(2)(v)]

E-0020 o o




Compliance Rating



Non-Compliant


CMS Tag YES NO

C. The policies and procedures must address a means to shelter in place for patients, staff, and volunteers who remain in the ASC. [416.54(b)(3)]

E-0022


1. The policies and procedures must address a system of medical documentation that does the following: [416.54(b)(4)]

E-0023 o o

a. Preserves patient information. [416.54(b)(4)(i)] E-0023 o o

b. Protects confidentiality of patient information. [416.54(b)(4)(ii)] E-0023 o o

c. Secures and maintains the availability of records. [416.54(b)(4)(iii)] E-0023 o o

2. The policies and procedures must address the use of volunteers in an emergency and other staffing strategies, including the process and role of integration of State and Federally designated heath care professionals to address surge needs during an emergency. [416.54(b)(5)]

E-0024 o o

3. The policies and procedures must address the role of the ASC under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergency management officials. [416.54(b)(6)]

E-0026 o o

Compliance Rating



Non-Compliant


CMS Tag YES NO

D. The ASC must develop and maintain an emergency preparedness communication plan that complies with Federal, State, and local laws and must be reviewed and updated at least annually. [416.54(c)]

E-0029


1. The communication plan must include names and contact information for the following: [416.54(c)(1)]

E-0030 o o

a. Staff. [416.54(c)(1)(i)] E-0030 o o

b. Entities providing services under arrangement. [416.54(c)(1)(ii)] E-0030 o o

c. Patients' physicians. [416.54(c)(1)(iii)] E-0030 o o

d. Volunteers. [416.54(c)(1)(iv)] E-0030 o o

2. The communication plan must include contact information for the following: [416.54(c)(2)]

E-0031 o o

a. Federal, State, tribal, regional, and local emergency preparedness staff. [416.54(c)(2)(i)]

E-0031 o o

b. Other sources of assistance. [416.54(c)(2)(ii)] E-0031 o o




Compliance Rating



Non-Compliant


CMS Tag YES NO

E. The communication plan must also include primary and alternate means for communicating with the following: [416.54(c)(3)]

E-0032


1. ASC staff. [416.54(c)(3)(i)] E-0032 o o

2. Federal, State, tribal, regional, and local emergency management agencies. [416.54(c)(3)(ii)]

E-0032 o o

3. The communication plan must include a method of sharing information and medical documentation for patients under the ASC's care, as necessary, with other health care providers to maintain the continuity of care. [416.54(c)(4)]

E-0033 o o

4. The communication plan must include a means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510(b)(1)(ii). [416.54(c)(5)]

E-0033 o o

5. The communication plan must include a means of providing information about the general condition and location of patients under the facility's care as permitted under 45 CFR 164.510(b)(4). [416.54(c)(6)]

E-0033 o o

6. The communication plan must include a means of providing information about the ASC's needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. [416.54(c)(7)]

E-0034 o o

Compliance Rating



Non-Compliant





CMS Tag YES NO

F. The ASC must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The ASC must do all of the following: [416.54(d)]

E-0036


1. Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing onsite services under arrangement, and volunteers, consistent with their expected roles. [416.54(d)(1)(i)]

E-0037 o o

2. Provide emergency preparedness training at least annually. [416.54(d)(1)(ii)] E-0037 o o

3. Maintain documentation of all emergency preparedness training. [416.54(d)(1)(iii)] E-0037 o o

4. Demonstrate staff knowledge of emergency procedures. [416.54(d)(1)(iv)] E-0037 o o

5. If the emergency preparedness policies and procedures are significantly updated, the ASC must conduct training on the updated policies and procedures. [416.54(d)(1)(v)]

E-0037 o o

Compliance Rating



Non-Compliant


CMS Tag YES NO

G. The ASC must conduct exercises to test the emergency plan at least annually. [416.54(d)(2)]

E-0039


1. The ASC must do the following: o o

a. The ASC must participate in an annual full-scale exercise that is community-based; or [416.54(d)(2)(i)]

E-0039

b. When a community-based exercise is not accessible, conduct a facility-based functional exercise annually; or [416.54(d)(2)(i)(A)]

E-0039

c. If the ASC experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ASC is exempt from engaging in one community-based or individual, facility-based functional exercise for one year following the onset of the emergency event. [416.54(d)(2)(i)(B)]

E-0039

2. Conduct an additional annual exercise that may include but is not limited to the following: [416.54(d)(2)(ii)]

E-0039 o o

a. A second full-scale exercise that is community-based, or an individual, facility-based functional exercise; or [416.54(d)(2)(ii)(A)]

E-0039

b. A mock disaster drill; or [416.54(d)(2)(ii)(B)] E-0039

c. A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. [416.54(d)(2)(ii)(C)]

E-0039




Compliance Rating



Non-Compliant


CMS Tag

H. The ASC must analyze its response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the ASC's emergency plan, as needed. [416.54(d)(2)(iii)]

E-0039

Compliance Rating



Non-Compliant


CMS Tag YES NO

I. The emergency preparedness plan, policies, and procedures must be reviewed and updated at least annually. [416.54(a)]

E-0004


1. The emergency preparedness policies and procedures must be reviewed and updated at least annually.

o o

2. The communication plan must be reviewed and updated at least annually. [416.54(c)] E-0029 o o

3. The training and testing program must be reviewed and updated at least annually. o o

Compliance Rating



Non-Compliant





CMS Tag YES NO NA

J. If an ASC is part of a healthcare system consisting of multiple separately certified healthcare facilities that elects to have a unified and integrated emergency preparedness program, the ASC may choose to participate in the healthcare system's coordinated emergency preparedness program. If elected, the unified and integrated emergency preparedness program must: [416.54(e)]

E-0042


1. Demonstrate that each separately certified facility within the system actively participated in the development of the unified and integrated emergency preparedness program. [416.54(e)(1)]

E-0042 o o o

2. Be developed and maintained in a manner that takes into account each separately certified facility's unique circumstances, patient populations, and services offered. [416.54(e)(2)]

E-0042 o o o

3. Demonstrate that each separately certified facility is capable of actively using the unified and integrated emergency preparedness program and is in compliance. [416.54(e)(3)]

E-0042 o o o

4. Include a unified and integrated emergency plan that meets the requirements of paragraphs (a)(2), (3), and (4) of this section. The unified and integrated emergency plan must also be based on and include the following: [416.54(e)(4)]

E-0042 o o o

a. A documented community-based risk assessment, utilizing an all-hazards approach. [416.54(e)(4)(i)]

E-0042 o o o

b. A documented individual facility-based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach. [416.54(e)(4)(ii)]

E-0042 o o o

5. Include integrated policies and procedures that meet the requirements set forth in paragraph (b) of this section, a coordinated communication plan and training and testing programs that meet the requirements of paragraphs (c) and (d) of this section, respectively. [416.54(e)(5)]

E-0042 o o o

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable



Adjunct Chapters Adjunct chapters will be applied based on the services provided by the organization seeking accreditation



9. Anesthesia Care Services

10. Surgical and Related Services

11. Pharmaceutical Services

12. Pathology and Medical Laboratory Services

13. Diagnostic and Other Imaging Services

18. Teaching and Publication Activities

19. Research Activities

20. Overnight Care and Services

24. Radiation Oncology Treatment Services

Adjunct Chapters

101


AAAHC strives to maintain alignment between our Medicare Deemed Status Accreditation Program and the non-MDS Accreditation Program. Please note that the Standards in the following non-MDS Program chapters have been excluded from this handbook as they are not applicable to an ASC in the Medicare Deemed Status Accreditation Program. However, for consistency, we have maintained the chapter numbering between the two handbooks.

Chapter

14 Dental Services 15 Travel Medicine 16 Health Education and Health Promotion 17 Behavioral Health Services 21 Occupational Health Services 22 Immediate/Urgent Care Services 23 Emergency Services 25 Medical Home



103


Chapter 9

Anesthesia Care Services In an accreditable organization, qualified health care professionals provide anesthesia care services in a safe and sanitary environment. Such an organization meets the following Standards. The provisions of this chapter apply to all care involving the administration of sedation and anesthesia in all ambulatory settings. The following definitions are used in determining how the Standards of this chapter are applied based on the level of anesthesia and sedation administered by an organization.

Definitions

Standards A through I of this chapter apply to all organizations, regardless of level(s) of anesthesia administered.

Local or topical anesthesia is the application of local anesthetic agents, in appropriate doses adjusted for weight.

Minimal sedation (anxiolysis) is a drug-induced state during which patients respond normally to verbal commands. Although cognitive function and coordination may be impaired, ventilatory and cardiovascular functions are unaffected. Inhaled nitrous oxide in low concentrations that would not reasonably be expected to result in loss of the patient’s life-preserving protective reflexes would be considered minimal sedation.

Standards J through R of this chapter apply to organizations that administer moderate sedation/ analgesia, regional anesthesia, deep sedation/ analgesia, or general anesthesia.

Moderate sedation/analgesia (conscious sedation) is a drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. (Reflex withdrawal from a painful stimulus is NOT considered a purposeful response.) No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained.

Regional anesthesia is the application of anesthetic medication around the nerve or nerves in a major region of the body, which supply the area that is targeted for the abolition of painful neural impulses. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained.

Deep sedation/analgesia is a drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. (Note that reflex withdrawal from a painful stimulus is NOT considered a purposeful response.) The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained.

General anesthesia is a drug-induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilator function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired.

Note: Because sedation is a continuum, it is not always possible to predict how an individual patient will respond. Individuals administering minimal or moderate sedation/ analgesia or regional anesthesia should be able to support the respiratory and cardiovascular system of patients who enter a state of deep sedation / analgesia, while those administering deep sedation/analgesia should be able to support the respiratory and cardiovascular system of patients who enter a state of general anesthesia.



Chapter 9: Anesthesia Care Services

Standards A through I apply to all organizations involved in the administration of sedation and anesthesia as defined on previous page, including those where only local or topical anesthesia or only minimal sedation is administered.

CMS Tag

A. Anesthesia services provided by the organization are limited to those techniques that have been approved by the governing body upon the recommendation of qualified professional personnel.

—

Compliance Rating



Non-Compliant


CMS Tag

B. The governing body has appointed one or more qualified physicians or dentists to supervise the anesthesia service.

—

Compliance Rating



Non-Compliant


CMS Tag YES NO

C. Anesthesia is only administered by health care professionals approved by the governing body to administer anesthesia in accordance with AAAHC Standards for credentialing and privileging.


1. Anesthetics must be administered by only: A qualified anesthesiologist; OR [416.42(b)(1)]

Q-0063 o o

2. Anesthetics must be administered by only: A physician qualified to administer anesthesia, a certified registered nurse anesthetist (CRNA) or an anesthesiologist’s assistant as defined in § 410.69(b) of this chapter, or a supervised trainee in an approved educational program. [416.42(b)(2)]

Q-0063 o o

References / Notes

• [416.42(c)(1)] An ASC may be exempted from the requirement for physician supervision of CRNAs as described in 42 CFR 416.42 (b)(2), if the State in which the ASC is located submits a letter to CMS signed by the Governor, following consultation with the State’s Boards of Medicine and Nursing, requesting exemption from physician supervision of CRNAs. The letter from the Governor must attest that he or she has consulted with State Boards of Medicine and Nursing about issues related to access to and the quality of anesthesia services in the State and has concluded that it is in the best interests of the State’s citizens to opt-out of the current physician supervision requirement, and that the opt-out is consistent with State law.

• [416.46(c)(2)] The request for exemption and recognition of State laws, and the withdrawal of the request may be submitted at any time, and are effective upon submission.

• [416.42(b)] [416.42(b)(2)] In those cases in which a non-physician administers the anesthesia, unless exempted in accordance with paragraph (c) of this section, the anesthetist must be under the supervision of the operating physician, and in the case of an anesthesiologist’s assistant, under the supervision of an anesthesiologist.




• Note: §410.69(b) Definitions. For purposes of this part — Anesthesia and related care means those services that a certified registered nurse anesthetist is legally authorized to perform in the state in which the services are furnished.

Compliance Rating



Non-Compliant


CMS Tag YES NO NA

D. Written policies and procedures for anesthesia services are present. —


1. Written policies and procedures address education, training, and supervision of personnel.

o o

2. Written policies and procedures address responsibilities of non-physician anesthetists.

o o o

3. Written policies and procedures address responsibilities of supervising physicians and dentists.

o o o




Non-Compliant







Non-Compliant







Non-Compliant





CMS Tag

E. The informed consent of the patient or of the patient’s representative, if applicable, is obtained before the procedure is performed.

—

References / Notes

• One consent form may be used to satisfy the requirements of this Standard and Standard 10.I.G.

Compliance Rating



Non-Compliant


CMS Tag YES NO

F. Resuscitation equipment is available. —


1. Oxygen is available. o o

2. A device such as a self-inflating hand resuscitator bag capable of administering at least 90% oxygen is available.

o o

3. Appropriate emergency drugs, supplies, and equipment are available. o o

4. A manual defibrillator, or an automated external defibrillator (AED), is available. o o

Compliance Rating



Non-Compliant




CMS Tag

G. Immediately before surgery, a physician or anesthetist as defined at §410.69(b) of this chapter must examine the patient to evaluate the risk of anesthesia. [416.42(a)(1)(ii)]

Q-0061

References / Notes

• A CRNA is defined in §410.69(b) as a “registered nurse who: 1. Is licensed as a registered professional nurse by the State in which the nurse practices; 2. Meets any licensure requirements the State imposes with respect to non-physician anesthetists; 3. Has graduated from a nurse anesthesia educational program that meets the standards of the Council on

Accreditation of Nurse Anesthesia Programs, or such other accreditation organization as may be designated by the Secretary; and

4. Meets the following criteria: i. Has passed a certification examination of the Council on Certification of Nurse Anesthetists, the Council

on Recertification of Nurse Anesthetists, or any other certification organization that may be designated by the Secretary; or

ii. Is a graduate of a program described in paragraph (3) of this definition and within 24 months after that graduation meets the requirements of paragraph (4)(i) of this definition.”

• An anesthesiologist’s assistant is defined at §410.69(b) as a “person who- 1. Works under the direction of an anesthesiologist; 2. Is in compliance with all applicable requirements of State law, including any licensure requirements the State

imposes on nonphysician anesthetists; and




3. Is a graduate of a medical school-based anesthesiologist’s assistant education program that – i. Is accredited by the Committee on Allied Health Education and Accreditation; and ii. Includes approximately two years of specialized basic science and clinical education in anesthesia at a

level that builds on a premedical undergraduate science background.”

Compliance Rating



Non-Compliant


CMS Tag YES NO

H. Clinical records reflect the administration of anesthesia. [416.47(b)(6)] Q-0162


1. Clinical record entries include: [416.47(b)(6)] Q-0162 o o

a. A pre-anesthesia assessment/evaluation.

b. A plan for anesthetic administration.

c. A chronologic record reflecting the anesthetic administered and the clinical status of the patient.

d. A post-anesthesia assessment/evaluation.

2. In accordance with AAAHC Standards for credentialing and privileging, anesthesia was administered by an appropriately privileged practitioner.

o o

Compliance Rating



Non-Compliant


CMS Tag

I. Before discharge from the ASC, each patient must be evaluated by a physician or by an anesthetist as defined in Title 42 CFR 410.69(b) of this chapter, in accordance with applicable State health and safety laws, standards of practice, and ASC policy, for proper anesthesia recovery. [416.42(a)(2)]

Q-0062

Compliance Rating



Non-Compliant





Standards J through R apply to organizations that administer moderate sedation/analgesia, regional anesthesia, deep sedation/analgesia, or general anesthesia.

CMS Tag YES NO NA

J. The oxygenation, ventilation, and circulation of the patient is continually evaluated and documented.

—


1. Continuous intra-operative physiologic monitoring includes: o o

a. Use of a pulse oximeter.

b. Blood pressure determination at frequent intervals.

c. Electrocardiogram (ECG) monitoring during the administration of moderate sedation/analgesia, deep sedation/analgesia, or general anesthesia.

2. During the administration of deep sedation/analgesia, the presence of exhaled CO2 is monitored.

o o o

3. During the administration of general anesthesia, end-tidal CO2 is monitored. o o o

4. During the administration of general anesthesia, a means of measuring body temperature is readily available.

o o o




Non-Compliant







Non-Compliant







Non-Compliant




Compliance Rating: if 1 element applies or Standard does not apply

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable






CMS Tag

K. A written policy regarding the assessment and management of acute pain has been adopted.

—

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable



CMS Tag YES NO

L Patients are observed and monitored in a post-anesthesia care unit, or in an area that provides equivalent care, by methods appropriate to each patient's medical condition and sedation/analgesia or anesthesia.

—


1. Patients are observed and monitored in a post-anesthesia care unit or in an area that provides equivalent care.

o o

2. Observation methods are appropriate for each patient's medical condition and sedation/analgesia or anesthesia.

o o

3. Appropriate monitoring equipment is present for the level(s) of anesthesia provided. o o

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant






CMS Tag

M. A written policy requires the presence of a physician, dentist, or other delegated, qualified health care professional supervised by a physician or dentist until the medical discharge of the patient following clinical recovery from the surgery/procedure and anesthesia.

—

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable






CMS Tag YES NO

N. At least one health care professional with current training in advanced cardiac life support (ACLS) is present to provide advanced resuscitative techniques until all patients operated on that day have been physically discharged.

—


1. Documentation of current ACLS training is present. o o

2. Initial ACLS training and subsequent retraining is obtained from the American Heart Association or other vendor that includes "hands-on" training and skills demonstration of airway management and automated external defibrillator (AED) use.

o o

3. A policy requires that health care professionals with ACLS training are present until that day's patients have been physically discharged.

o o

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant






CMS Tag YES NO

O. If anesthetic and resuscitative agents known to trigger malignant hyperthermia are available in the facility, staff are prepared to respond to an episode of malignant hyperthermia.

—


1. Written treatment protocols based on current, nationally recognized guidelines have been adopted.

o o

2. The protocols include: o o

a. The administration of dantrolene and other medications.

b. Readily available methods of continuous cooling and temperature monitoring.

c. Initiation of an emergency transfer protocol.

3. The protocols are posted and/or immediately available in each area where triggering agents might be used.

o o

4. Documentation demonstrates that all appropriate staff have been educated and trained in the recognition and treatment of malignant hyperthermia.

o o

5. At least annually, a malignant hyperthermia drill is conducted and documented. o o

References / Notes

• An example is the Malignant Hyperthermia Association of the United States (MHAUS) protocol. See https://www.mhaus.org/

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant











CMS Tag YES NO

P. A written policy prohibits the administration of moderate or deep sedation or general anesthesia unless a physician, dentist, or other qualified individual supervised by a physician or dentist, in addition to the one performing the surgery, is present to monitor the patient.

—


1. A written policy is present. o o

2. Clinical records demonstrate that the policy is followed. o o

References / Notes

• Not all states require physician supervision of CRNAs. The operating physician or dentist may be the supervising physician or dentist. During moderate sedation, the additional individual may assist with minor, interruptible tasks.

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant






CMS Tag

Q. If anesthesia is provided by other than an anesthesiologist, oral and maxillofacial surgeon, certified registered nurse anesthetist, or an anesthesiologist assistant within his/her scope of practice, the governing body has granted such personnel privileges to administer sedative, hypnotic, or analgesic drugs that do not have an antagonist medication (for example, propofol), if these drugs are used.

—

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable



CMS Tag

R. If anesthesia is provided by other than an anesthesiologist, oral and maxillofacial surgeon, certified registered nurse anesthetist, or an anesthesiologist assistant within his/her scope of practice, a written protocol defines how the organization will respond in the event that a deeper-than-intended level of sedation occurs.

—

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable






Standards S and T apply to organizations that provide children with any level of anesthesia higher than local/topical.

CMS Tag YES NO

S. If pediatric patients are served, health care professionals with current training in pediatric advanced life support (PALS) and age- and size-appropriate resuscitative equipment are available at all times until pediatric patients operated on that day have been physically discharged.

—


1. Documentation of current PALS training and certification is present. o o

2. Initial PALS training and subsequent retraining is obtained from the American Heart Association or another vendor that includes "hands-on" training and skills demonstration of airway management and automated external defibrillator (AED) use.

o o

3. Documentation of training in age- and size-appropriate resuscitative equipment is present.

o o

4. A policy requires that health care professionals with training in PALS and pediatric resuscitative equipment are present until that day's patients have been physically discharged.

o o

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant




present



CMS Tag YES NO

T. If pediatric patients are served, the equipment, medication, and resuscitative capabilities required for pediatric patients are present.

—


1. Age- and size-appropriate anesthesia equipment is present. o o

2. Medications in appropriate concentrations are present. o o

3. Age- and size-appropriate resuscitative equipment is present. o o

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant






113


Chapter 10

Surgical and Related Services Surgical and related services in an accreditable organization are performed in a safe and sanitary environment by qualified health care professionals to whom the governing body has granted privileges to perform procedures. The Standards in this chapter apply to organizations that perform any invasive procedures, such as pain management, endoscopy procedures, cardiac catheterization, lithotripsy, and in-vitro fertilization, as well as surgery. In this chapter and throughout this Handbook, the terms “surgery,” “procedure,” and “operation” are used interchangeably. The use of any of these terms is to reference any such skill, method, or technique that involves cutting, abrading, suturing, lasering, or otherwise physically entering or changing body tissues and organs, including invasive pain management procedures. Note: Some Standards may not apply to organizations that only perform minor, superficial procedures without anesthesia or under local or topical anesthesia.

Subchapter I – General Requirements: This subchapter describes general requirements for an organization that provides surgical and related services.

CMS Tag

A. Surgical procedures must be performed in a safe manner by qualified physicians who have been granted clinical privileges by the governing body of the ASC in accordance with approved policies and procedures of the ASC. [416.42]

Q-0060

Compliance Rating



Non-Compliant


CMS Tag

B. Surgical procedures performed are limited to those approved by the governing body upon the recommendation of qualified medical staff.

—

Compliance Rating



Non-Compliant




Chapter 10: Surgical and Related Services

CMS Tag

C. The governing body has appointed one or more qualified physicians, dentists, or other qualified practitioners to supervise surgical services.

—

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable



CMS Tag YES NO

D. The ASC must develop and maintain a policy regarding the requirement for medical history and physical examination prior to surgery. [416.52(a)(1)]

Q-0261


1. The policy must include the requirement for completion of a medical history and physical examination no more than 30 days prior to surgery. [416.52(a)(1)(i)]

Q-0261 o o

2. The policy must address, but is not limited to, the following factors: patient age, diagnosis, the type and number of procedures scheduled to be performed on the same surgery date, known comorbidities, and the planned anesthesia level. [416.52(a)(1)(ii)]

Q-0261 o o

3. The policy must be based on any applicable nationally recognized standards of practice and guidelines, and any applicable state and local health and safety laws. [416.52(a)(1)(iii)]

Q-0261 o o

Compliance Rating



Non-Compliant





CMS Tag YES NO

E. An appropriate and current health history is completed and incorporated into the patient's clinical record no more than 30 days prior to the scheduled surgery (or according to local, state, or federal requirement).

—


1. Health histories are present in the clinical records no more than 30 days prior to the scheduled surgery/procedure (or according to local, state, or federal requirement).

o o

2. Health histories include current prescription and non-prescription medications. o o

3. Health histories include medication dosages, when available. o o

4. Health histories include the results of a physical examination. o o

5. Health histories include pertinent diagnostic studies. o o

Compliance Rating



Non-Compliant






CMS Tag YES NO

F. The ASC must ensure each patient has the appropriate pre-surgical and post-surgical assessments completed and that all elements of the discharge requirements are completed. [416.52]

Q-0260


1. Upon admission, each patient must have a pre-surgical assessment completed by a physician who will be performing the procedure or other qualified practitioner in accordance with applicable State health and safety laws, standards of practice, and ASC policy. [416.52(a)(2)]

Q-0262 o o

2. The pre-surgical assessment must include documentation of any allergies to drugs and biologicals. [416.52(a)(3)]

Q-0262 o o

3. The patient’s medical history and physical assessment must be placed in the patient’s medical record prior to the surgical procedure. [416.52(a)(4)]

Q-0263 o o

Compliance Rating



Non-Compliant





CMS Tag YES NO

G. Informed consent for the proposed procedure is obtained. —


1. Documentation is present to demonstrate that the following have been discussed with the patient:

o o

a. The necessity or appropriateness of the proposed procedure or surgery.

b. Alternative treatment techniques.

2. The clinical record demonstrates that the patient's written consent, or that of the patient's representative, was obtained before the surgery or procedure was performed.

o o

Compliance Rating



Non-Compliant




CMS Tag

H. Immediately before surgery, a physician must examine the patient to evaluate the risk of the procedure to be performed. [416.42(a)(1)(i)]

Q-0061

Compliance Rating



Non-Compliant


CMS Tag

I. A written policy requires that, whenever patients are present in the facility, at least one physician, dentist, or other practitioner qualified to address medical emergencies and authorized by the governing body is present or immediately available by telephone.

—

Compliance Rating



Non-Compliant





CMS Tag YES NO

J. The organization has written policies regarding the procedures and treatments offered to patients.

—


1. The written policies address the criteria for patient selection. o o

2. The written policies address the need for anesthesia support. o o

3. The written policies address post-procedural care. o o

4. The written policies address staffing requirements to ensure that registered nurse(s) or other health care professionals assisting in the provision of surgical services are available in sufficient numbers for the surgical care provided.

o o

Compliance Rating



Non-Compliant




CMS Tag

K. If procedures performed pose the risk that blood loss may require blood replacement, the organization has written policies and procedures to address this situation.

—

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable






CMS Tag YES NO

L. If applicable, protocols for the handling, maintenance, and storage of blood or blood products for transfusion, and/or human cells or tissues for transplantation, are present.

—


1. Written protocols for handling, maintaining and storing blood or blood products for transfusion are present.

o o

2. Written protocols for handling, maintaining and storing human cells for transplantation are present.

o o

3. The written protocols are consistent with those of a nationally recognized authority, such as the American Association of Tissue Banks (AATB) or the U.S. Food and Drug Administration (FDA).

o o

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant






CMS Tag

M. A written policy is in place for assessing the risk of, and implementing practices to prevent, deep vein thrombosis when appropriate for the patient.

—

References / Notes

• May not apply depending on services provided by the organization.

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable






CMS Tag YES NO

N. If pediatric patients are served, written policies define appropriate care. —


1. Policies address criteria for treatment as a pediatric patient. o o

2. Policies address requirements for the appropriate pediatric: o o

a. Equipment.

b. Supplies.

c. Medications.

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant






CMS Tag YES NO

O. Attire contaminated with blood or body fluid is laundered by an approved laundry.

—


1. The laundry adheres to nationally recognized guidelines. o o

2. The laundry has been approved by the organization. o o

Compliance Rating



Non-Compliant







CMS Tag YES NO NA

P. The surgical environment contains safeguards to protect patients and others from cross-infection.

—


1. Written policies define the proper attire of all persons entering operating or procedure rooms.

o o

2 Written policies address acceptable aseptic techniques to be used by all persons in the surgical area.

o o

3. Written policies address the removal or covering of patient clothing prior to the patient's entry into a surgical area, as needed to minimize the potential contamination of the surgical environment and surgical staff.

o o o

4. Written policies require freshly laundered attire to be donned in an area inside of the organization prior to entry into areas designated as restricted.

o o o

5. Written policies address appropriate and timely surgical hand antisepsis (scrub) using either an antimicrobial soap or an alcohol-based hand rub according to product manufacturer's recommended guidelines.

o o o

6. Written policies address pre-procedure site antisepsis, as appropriate to service(s) provided and patient requirements and needs.

o o o

7. Environmental controls adopted by the organization for temperature, humidity and air pressure following nationally recognized guidelines.

o o o

References / Notes

• Elements 3-7 may be NA if only non-sterile procedures are conducted (e.g., endoscopy).




Non-Compliant









Non-Compliant







CMS Tag YES NO

Q. If procedures requiring counts of sponges, sharps, and instruments are performed, a written policy for conducting counts is present.

—


1. The policy addresses the types of procedures requiring counts of sponges, sharps, and instruments.

o o

2. The policy requires a count before the start of the procedure and before skin closure. o o

3. The policy addresses how start and end counts are reported to the surgeon. o o

4. The policy requires documentation of the counts in the patient's record. o o

5. The policy includes actions to be taken if the count is not correct. o o

6. Observation and interviews confirm that the policy is followed. o o

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant




3 or 4 of 6 elements are

present




CMS Tag YES NO

R. Prior to the surgery or procedure, the intended procedure is verified. —


1. A written verification policy is present. o o

2. The patient or their authorized representative is involved in the verification process. o o

3. Clinical records contain documentation of procedure verification. o o

Compliance Rating



Non-Compliant







CMS Tag YES NO

S. Prior to a surgery or procedure involving level or laterality, the site is marked. —


1. A written site marking policy is present. o o

2. The policy includes the organization’s definition of “surgical team.” o o

3. The patient or their authorized representative is involved in the site marking process prior to the administration of anesthesia.

o o

4. The site is marked by the person performing the procedure, or by their designated member of the surgical team who will be present during the time-out.

o o

5. Clinical records contain documentation of site marking. o o

References / Notes

• Standard does not apply if no procedures involving level or laterality are performed.

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant








CMS Tag YES NO

T. A time-out is conducted immediately prior to beginning a procedure. —


1. The provider performing the procedure assumes responsibility for the time-out. o o

2. The entire team is engaged in the time-out. o o

3. During the time-out, the following items are verified: o o

a. Patient identification.

b. Intended procedure.

c. Correct surgical/procedural site.

d. All equipment necessary for performing the scheduled procedure is immediately available and functional in the operating/procedure room.

e. Any implantable devices intended for use during the procedure were prepared before the procedure and are available.

Compliance Rating



Non-Compliant







CMS Tag YES NO NA

U. The findings and techniques of a procedure are accurately and completely documented immediately after the procedure.

—


1. The health care professional who performed the procedure documents the findings and techniques.

o o

2. The documentation is immediately available for patient care. o o

3. The documentation is incorporated into the patient's clinical record. o o

4. When pre-operative antibiotics are ordered, the antibiotic and time of administration are documented in the patient's clinical record.

o o o

5. If tissues are removed during surgery: o o o

a. A pathologist examines the tissues, except for those exempted in writing by the governing body after medical review.

b. The signed report of the pathologist is incorporated into the patient's clinical record.




Non-Compliant









Non-Compliant







Non-Compliant







CMS Tag YES NO

V. Written guidelines for the transition of care from one provider to another are present.

—


1. The guidelines address information to be transferred about a patient's care including, at minimum:

o o

a. Treatment/services.

b. Current condition.

c. Any recent or anticipated changes.

2. The guidelines address how the information will be communicated among members of the health care team.

o o

Compliance Rating



Non-Compliant




CMS Tag

W. The patient’s post-surgical condition must be assessed and documented in the medical record by a physician, other qualified practitioner, or a registered nurse with, at a minimum, post-operative care experience in accordance with applicable State health and safety laws, standards of practice, and ASC policy. [416.52(b)(1)]

Q-0264

References / Notes

• Other qualified health care professionals are qualified by virtue of education, experience, competence, professional licensure, and state laws, rules, and regulations. Other health care professionals must be approved for the administration of anesthesia by the governing body pursuant to Chapter 2.II.

Compliance Rating



Non-Compliant





CMS Tag YES NO

X. The ASC must provide each patient with written discharge instructions and overnight supplies. When appropriate, make a follow-up appointment with the physician, and ensure that all patients are informed, either in advance of their surgical procedure or prior to leaving the ASC, of their prescriptions, post-operative instructions and physician contact information for follow-up care. [416.52(c)(1)]

Q-0265


1. Post-surgical needs must be addressed and included in the discharge notes. [416.52(b)(2)]

Q-0264 o o

2. The ASC must ensure each patient has a discharge order, signed by the physician who performed the surgery or procedure in accordance with applicable State health and safety laws, standards of practice, and ASC policy. [416.52(c)(2)]

Q-0266 o o

3. The ASC must ensure all patients are discharged in the company of a responsible adult, except those patients exempted by the attending physician. [416.52(c)(3)]

Q-0267 o o

Compliance Rating



Non-Compliant


Subchapter II — Laser, Light-Based Technologies, and Other Energy-Emitting Equipment: This subchapter addresses surgery or procedures that involve lasers, light-based technologies, or other energy-emitting equipment.

CMS Tag

A. In accordance with Chapter 2.II, the governing body has granted each provider privileges for each energy-emitting device that he or she uses.

—

Compliance Rating



Non-Compliant





CMS Tag YES NO

B. Written policies and procedures for each device are present. —


1. The policies and procedures include a list of each type of laser used in the facility. o o

2. The policies and procedures require a laser safety program. o o

a. The program is supervised by an individual delegated the responsibility and authority to serve as Medical Laser Safety Officer (MLSO).

b. The MLSO has the requisite education and training applicable to each type of laser used in the facility, including knowledge of laser-specific information (e.g., wave lengths, pulse shapes, modes, power/energy classification, controlled areas).

c. The policies and procedures require that laser operators have no competing responsibilities that would leave the laser unattended during active use.

3. The policies and procedures include a requirement for all personnel working with these devices to be adequately trained in the safety and use of each type of device used.

o o

4. The policies and procedures require safe practices to be followed. o o

a. All procedures are performed in accordance with the device manufacturer's guidelines.

b. All procedures are performed consistent with the current version of the ANSI Standard for Safe Use of Lasers in Health Care Facilities.

Compliance Rating



Non-Compliant




CMS Tag YES NO NA

C. Safety measures for the laser(s) used are in place. —


1. Safety measures include the use of door and window coverings, where appropriate. o o

2. Safety measures include prominently displayed warning signs at the entrance to treatment areas during procedures, specific to the type of laser in use.

o o

3. Safety measures include a requirement for personnel in treatment areas to use protective eyewear as recommended by the device manufacturer.

o o

4. Safety measures include the use of smoke evacuators and other devices to control tissue debris.

o o o

5. Safety measures include the use of high filtration masks and/or wall suction with filters to minimize laser plume inhalation, when appropriate.

o o o

6. Safety measures include appropriate disinfection or sterilization of components that have direct patient contact.

o o

7. Safety measures include inspection and testing of the devices according to the manufacturer's instructions, as documented by maintenance logs.

o o







Non-Compliant









Non-Compliant









Non-Compliant






CMS Tag YES NO NA

D. Fire protection measures for lasers are in place. —


1. Fire protection measures include the immediate availability of electrical-rated fire extinguishers for equipment fires.

o o

2. Fire protection measures include the maintenance of a wet environment around the operative field.

o o o

3. Fire protection measures include the immediate availability of an open container of saline or water where ignition of flammable materials is possible.

o o o

4. Fire protection measures include the adoption of nationally recognized safety guidelines for the use of laser equipment.

o o

5. Fire protection measures include the use of noncombustible materials, supplies, and solutions as appropriate.

o o

6. Fire protection measures include procedures for ensuring that nothing is in front of the laser other than the tissue being lasered.

o o




Non-Compliant









Non-Compliant












Non-Compliant




CMS Tag YES NO

E. Safeguards are in place to ensure patient safety when lasers are used. —


1. Patient safety measures include protection of the patient's eyes, skin, hair, and other exposed areas.

o o

2. Patient safety measures include the use of non-reflective surgical instruments and supplies, when available.

o o

3. Patient safety measures include educating patients regarding procedure risks and potential complications, as documented by the informed consent.

o o

Compliance Rating



Non-Compliant




Subchapter III — Renal Lithotripsy Services: Renal lithotripsy services provided by the organization meet the needs of the patients and are provided in accordance with ethical and professional practices as well as legal requirements.

CMS Tag

A. The governing body has designated one or more qualified urologists to oversee lithotripsy services.

—

Compliance Rating



Non-Compliant





CMS Tag YES NO NA

B. Allied health care personnel assisting in the provision of lithotripsy services are appropriately qualified and trained.

—


1. If the allied health care personnel are organization staff members: o o o

a. All such personnel meet state and federal licensure requirements for the operation of radiation equipment.

b. Documentation of staff education, including orientation to equipment, is present.

2. If outside providers of lithotripsy services are used, the vendor provides the accredited organization with documentation of the following for its personnel providing services:

o o o

a. Appropriate training and licensure.

b. Ongoing education.

c. Annual competency evaluation.




Non-Compliant







Non-Compliant


CMS Tag YES NO

C. Equipment, adequate supplies, and written policies and procedures for providing appropriate lithotripsy treatment are present.

—


1. Observation and interviews confirm that the following are adequate to provide treatment in accordance with manufacturer's guidelines:

o o

a. Equipment.

b. Supplies.

2. The written guidelines address the following in accordance with manufacturer's instructions:

o o

a. Indications.

b. Contraindications.

c. Maximum power setting.

d. Maximum number of shocks.

e. Position of patient.




f. Patient size and weight.

g. Utilization of equipment.

Compliance Rating



Non-Compliant




CMS Tag YES NO

D. Written policies for the provision of lithotripsy services are present. —


1. Policies include a recognized methodology for diagnosis and treatment, including pre-procedure evaluation (lab work, x-rays, etc.).

o o

2. Policies include the requirement that a provider shall perform the treatment and be present during treatment.

o o

3. Policies include criteria for patient selection. o o

4. Policies include the administration of anesthesia/medication. o o

5. Policies address the correction of medication-related and other medical conditions contributing to coagulopathy and the relationship to lithotripsy.

o o

6. Policies address pre- and post-procedure teaching. o o

References / Notes

• A wide choice of anesthetic methods is available and appropriate. Successful lithotripsy requires the appropriate administration of anesthesia/medication for patient comfort and compliance. A patient’s health, habits, and history must be such that he/she can safely undergo anesthesia/analgesia for lithotripsy.

Compliance Rating



Non-Compliant









CMS Tag YES NO NA

E. Written policies addressing the safety aspects of lithotripsy treatment are present.

—


1. The policies require daily logging of lithotripter calibration/equipment checks on days when lithotripsy is provided.

o o

2. The policies require preventive maintenance logs. o o

3. The policies require maintenance records, including current documentation from the service contract provider that any malfunctions have been corrected.

o o

4. If outside providers of lithotripsy services are used, the policies require that equipment maintenance records are available to the accredited organization when the equipment is onsite.

o o o

5. The policies require documentation from contracted vendors performing equipment calibration and preventive maintenance that work has been completed according to the contract.

o o




Non-Compliant









Non-Compliant







CMS Tag YES NO

F. Clinical records include entries specific to lithotripsy services provided. —


1. Clinical record entries include a history and physical indicating presence, location, and size of kidney stone.

o o

2. Clinical record entries include documentation of the patient's symptoms. o o

3. Clinical record entries include method of determining location. o o

4. Clinical record entries include confirmation of presence of stone immediately prior to treatment.

o o

5. Clinical record entries include the operative treatment record: o o

a. Selection of treatment modality.

b. Number of shocks.

c. Energy level.

d. Radiation exposure time.

References / Notes

• These entries must be present, in addition to the requirements of Chapter 6.

Compliance Rating



Non-Compliant






133


Chapter 11

Pharmaceutical Services Pharmaceutical services provided by an accreditable organization meet the needs of the patients and are provided in accordance with ethical and professional practices and legal requirements. Note: This chapter applies to any organization that uses drugs or pharmaceutical medical supplies, regardless of the presence or absence of an onsite pharmacy.

CMS Tag

A. Pharmaceutical services are directed by a qualified licensed provider. —

Compliance Rating



Non-Compliant


CMS Tag

B. If the organization owns or operates a pharmacy, it is supervised by a licensed pharmacist.

—

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable



CMS Tag

C. Documentation is present to demonstrate that patients are not required to use a pharmacy owned or operated by the organization.

—

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable





Chapter 11: Pharmaceutical Services

CMS Tag YES NO NA

D. Pharmaceutical services are provided in accordance with standards of care and prevailing laws and regulations.

—


1. If state licensure is required, a current license is posted. o o o

2. When controlled substances are present, current DEA certification is maintained onsite and readily retrievable by authorized personnel.

o o o

3. Through interviews, staff demonstrates knowledge of prevailing pharmaceutical laws and regulations.

o o

4. Direct access to current drug information and other decision support resources is available to all relevant staff.

o o




Non-Compliant







Non-Compliant







Non-Compliant




CMS Tag

E. The ASC must provide drugs and biologicals in a safe and effective manner, in accordance with accepted professional practice, and under the direction of an individual designated responsible for pharmaceutical services. [416.48]

Q-0180

Compliance Rating



Non-Compliant





CMS Tag YES NO

F. Drugs must be prepared and administered according to established policies and acceptable standards of practice. [416.48(a)]

Q-0181


1. Adverse reactions must be reported to the physician responsible for the patient and must be documented in the record. [416.48(a)(1)]

Q-0182 o o

2. Blood and blood products must be administered only by physicians or registered nurses. [416.48(a)(2)]

Q-0183 o o

3. Orders given orally for drugs and biologicals must be followed by a written order and signed by the prescribing physician. [416.48(a)(3)]

Q-0184 o o

Compliance Rating



Non-Compliant


CMS Tag YES NO

G. Pharmaceutical services made available through a contractual agreement are provided in accordance with the same professional practices and legal requirements required if such services were provided directly by the organization.

—


1. A current contract is in place. o o

2. Documentation is present demonstrating that the pharmacy contractor is appropriately licensed and/or certified.

o o

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant






CMS Tag YES NO

H. The medication inventory is monitored to track the presence or absence of high-alert medications and medications with confused drug names.

—


1. A written policy describes the monitoring process and responsibility(ies) for its implementation.

o o

2. Documentation demonstrates that relevant staff have been trained on the policy. o o

3. Monitoring activities are documented. o o




Compliance Rating



Non-Compliant




CMS Tag YES NO

I. Procedures are in place to prevent errors from high-alert medications. —


1. A list of high-alert medications currently present in the facility is maintained. o o

2. Processes are in place to prevent errors from administration of these medications, in accordance with nationally recognized guidelines.

o o

References / Notes

• For a list of high-alert medications, see https://www.ismp.org/sites/default/files/attachments/2017-11/highAlert-community.pdf

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant






CMS Tag YES NO

J. Procedures are in place to prevent errors from medications with confused drug names.

—


1. A list of medications with confused drug names currently present in the facility is present.

o o

2. Processes are in place to prevent errors from administration of these medications, in accordance with nationally recognized guidelines.

o o

References / Notes

• “Confused drug names” refers to drugs that were previously called "look-alike, sound-alike" medications. For a list of such drugs, see https://www.ismp.org/recommendations/confused-drug-names-list

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant









CMS Tag YES NO NA

K. Drug storage and security, including recordkeeping, are maintained to ensure the control and safe dispensing of drugs (including samples), to minimize medication errors, and to prevent diversion in compliance with prevailing laws and regulations.

—


1. Procedures are in place to ensure that prescription pads, if used, are controlled and secured from unauthorized access.

o o o

2. Pre-signed and/or post-dated prescriptions are prohibited by written policy. o o

3. Procedures are in place to ensure that electronic prescribing systems, if used, are controlled and secured from unauthorized access.

o o o

4. Medications are segregated into organized, labeled storage areas designed to minimize drug selection errors.

o o

5. If a high-alert medication is present for which there is an antidote, rescue, or reversal agent, the agent is stocked in the same area as the medication along with appropriate directions for use.

o o o

6. Medications are stored and managed in accordance with manufacturer requirements, and state and/or CDC guidelines.

o o




Non-Compliant









Non-Compliant









Non-Compliant







Non-Compliant







CMS Tag

L. Interviews with staff, and/or observations of patient interaction, confirm that patients are provided with information concerning the safe and effective use of medications consistent with legal requirements and patient needs.

—

Compliance Rating



Non-Compliant


CMS Tag YES NO

M. If not administered immediately, all medications (injectable, oral, etc.) removed from the original container or packaging are labeled in a standard format in accordance with law, regulation and standards of practice.

—


1. A written policy addresses the labeling of such medications. o o

2. At minimum, the policy requires that labels include: o o

a. Drug name(s).

b. Drug strength(s).

c. Amount(s) or volume(s) if not apparent from the container or packaging.

d. Expiration date and time.

e. Name or initials of person transferring the drug(s).

References / Notes

• Immediate administration is when the person who prepares or transfers the drug(s) in a new container completely administers (or directly witnesses the administration of the drug(s) to the patient without any break in the process, and administers some amount of the medication within 1 hour of preparation or transfer.

• “Original container or packaging” includes syringes, basins, bottles, bags, etc.

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant









CMS Tag YES NO

N. A written policy is present addressing the disposal or return of expired, damaged, and recalled medications in accordance with prevailing laws and regulations and accepted guidelines.

—


1. A written policy is present. o o

2. The policy includes the monitoring of all medications, including vaccines and samples, for expiration dates on a regular basis.

o o

3. The policy includes expired, damaged and recalled drugs to be removed are segregated from drugs available for active use.

o o

4. The policy includes such drugs are disposed of or returned in a safe manner that prevents unauthorized access and diversion.

o o

Compliance Rating



Non-Compliant




CMS Tag YES NO

O. Procedures are in place for the maintenance, cleaning, distribution, and use of devices such as nebulizer units, intravenous infusion pumps, or other mechanical device used in the medication delivery process.

—


1. Procedures adhere to manufacturers' instructions. o o

2. Documentation is present to demonstrate that relevant staff has been trained in the procedures.

o o

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant









CMS Tag YES NO

P. Nationally recognized guidelines for vaccine storage and handling are followed.

—


1. Nationally recognized guidelines have been adopted by the governing body. o o

2. Written policies and procedures are present for routine storage and handling. o o

3. Written policies and procedures are present for storage, handling and transport in case of emergency (e.g., equipment failure, power outage, natural disasters).

o o

4. Documentation demonstrates that staff who receive, handle and/or administer vaccines have been trained on the policies and procedures.

o o

5. The vaccine storage unit is equipped with a temperature monitoring device in accordance with the adopted guidelines.

o o

6. Staff demonstrate knowledge of procedures to follow if vaccines are exposed to a temperature excursion.

o o

References / Notes

• For an example, see www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf. This Standard applies to all organizations that store and handle vaccines for administration to patients and/or staff.

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant





present




141


Chapter 12

Pathology and Medical Laboratory Services Laboratory services provided by an accreditable organization meet the needs of the patients and are provided in accordance with ethical and professional practices and legal requirements. Such an organization has the following characteristics. This chapter apples to ASCs providing services that meet the Clinical Laboratory improvement Amendments (CLIA) of 1988.

CMS Tag

A. Condition for Coverage - Laboratory and radiologic services. [416.49] Q-0200

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable



CMS Tag

B. If the ASC performs laboratory services, it must meet the requirements of Title 42 CFR Part 493. [416.49(a)]

Q-0201

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable



CMS Tag

C. If the ASC does not provide its own laboratory services, it must have procedures for obtaining routine and emergency laboratory services from a certified laboratory in accordance with Title 42 CFR Part 493. The referral laboratory must be certified in the appropriate specialties and subspecialties of service to perform the referred tests in accordance with the requirements of Title 42 CFR Part 493. [416.49(a)]

Q-0201

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable





Chapter 12: Pathology and Medical Laboratory Services

CMS Tag

D. As appropriate for the laboratory services performed, a current CLIA Certificate of Waiver, and/or a current Certificate for Provider Performed Microscopy Procedures (PPMP), and/or a current Certificate of Registration, Compliance or Accreditation is present. [416.49(a)]

Q-0201

References / Notes

• Standard does not apply if the State licensure or certification program is exempt from CLIA program requirements.

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable



CMS Tag

E. If the organization has obtained a CLIA Certificate for Provider Performed Microscopy Procedures, or a CLIA Certificate of Registration, Compliance or Accreditation, services are provided under the direction of a pathologist, other physician, or other qualified individual as delineated under CLIA.

—

References / Notes

• Standard does not apply if the State licensure or certification program is exempt from CLIA program requirements.

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable



CMS Tag

F. A current state medical laboratory license or certificate appropriate for the level of testing performed is present.

—

References / Notes

• Standard applies if State licensure program is exempt from CLIA program requirements, or if State and CLIA certification are both required.

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable






CMS Tag

G. Provider-performed microscopy, moderate complexity testing and high complexity testing are provided under the direction of a pathologist, other physician, or other qualified individual as specified by the state for the level of testing performed.

—

References /Notes

• Standard applies if these services are provided and State licensure program is exempt from CLIA program requirements, or if State and CLIA certification are both required. Standard does not apply if these services are not provided.

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable



CMS Tag

H. If the organization has obtained a CLIA Certificate of Waiver or a state license or certificate to perform waived testing, services are provided under the direction of an individual holding the qualifications required by the state, if any, for this position. If the state does not have qualification requirements, services are provided under the direction of a person holding the qualifications required by the organization for this position.

—

Compliance Rating



Non-Compliant


CMS Tag YES NO

I. Laboratory services are conducted by qualified personnel. —


1. Staff members with laboratory responsibilities are appropriately trained for their roles, as demonstrated by documented competency tests.

o o

2. Observation and interviews confirm that a sufficient number of trained and experienced personnel are available to supervise and conduct the work of the laboratory.

o o

Compliance Rating



Non-Compliant







CMS Tag YES NO

J. Pathology and medical laboratory services provided adequately support the organization's clinical capabilities.

—


1. Tests are performed in a timely manner, as defined by the organization's policies. o o

2. Test results are made available to the ordering provider. o o

3. Test results are documented in the patient's medical record in accordance with the organization's policies.

o o

Compliance Rating



Non-Compliant




CMS Tag

K. Laboratory test results are reviewed and acknowledged in writing (manually or electronically) by the ordering provider or qualified designee.

—

Compliance Rating



Non-Compliant


CMS Tag YES NO NA

L. Laboratory quality control procedures are performed. —


1. Quality controls are performed in accordance with manufacturer instructions. o o

2. The results of quality control procedures are documented. o o

3. Equipment is calibrated in accordance with manufacturer instructions. o o o

4. Validation tests for new equipment are performed in accordance with manufacturer instructions.

o o o

References /Notes

• Elements 3 and 4 apply only if moderate or complex testing is performed.







Non-Compliant







Non-Compliant







Non-Compliant




CMS Tag

M. Proficiency testing is performed if required by CLIA, the CLIA accrediting body, the state, and/or the organization's policies.

—

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable



CMS Tag YES NO

N. Established laboratory procedures are followed. —


1. At minimum, procedures are established for obtaining, identifying, storing, and transporting specimens.

o o

2. Staff members with laboratory responsibilities demonstrate understanding of the established procedures.

o o

3. Procedures are in place to obtain routine and emergency laboratory services outside of the organization's capabilities from a hospital or licensed medical or clinical laboratory.

o o

Compliance Rating



Non-Compliant







CMS Tag

O. Complete written descriptions of each test procedure performed are available to staff with laboratory responsibilities.

—

References / Notes

• As applicable for each test, such descriptions include information about patient preparation, specimen requirements and criteria for specimen rejection, reagents, calibration procedures, quality control, step-by-step instructions for performance of the test, result reporting, reporting of critical values, and reference ranges.

Compliance Rating



Non-Compliant


CMS Tag YES NO

P. Laboratory work is performed with optimal accuracy, precision, efficiency, and safety.

—


1. All test kits, laboratory devices and supporting supplies are FDA approved for use under the type of CLIA or state certificate obtained.

o o

2. Observation and interviews confirm that the following are sufficient: o o

a. Space.

b. Equipment.

c. Supplies.

References / Notes

• Not all “supporting supplies” must be FDA approved, e.g., cotton balls.

Compliance Rating



Non-Compliant




147


Chapter 13

Diagnostic and Other Imaging Services Imaging services within an accreditable organization, including those used for screening, diagnosing, monitoring, or assisting with procedures provided, meet the needs of the patients and are provided in accordance with ethical and professional practices and legal requirements. Imaging services may include, but are not limited to radiographic, fluoroscopic, magnetic resonance, and/or ultrasonic imaging. Such an organization meets the following Standards.

All Standards apply to organizations that provide imaging services for screening, diagnosing, monitoring, or assisting with procedures. Standards 13.K, L, M and N do not apply if the organization only provides peri-operative imaging services.

CMS Tag

A. Condition for Coverage - Laboratory and radiologic services. [416.49] Q-0200

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable



CMS Tag

B. If radiologic services are utilized, the governing body must appoint an individual qualified in accordance with State law and ASC policies who is responsible for assuring all radiologic services are provided in accordance with the requirements of this section. [416.49(b)(2)]

Q-0204

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable





Chapter 13: Diagnostic and Other Imaging Services

CMS Tag

C. Radiologic services may only be provided when integral to procedures offered by the ASC. [416.49(b)(1)]

Q-0202

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable



CMS Tag YES NO

D. The radiologic services must meet the requirements specified in Parts 482.26(b), (c)(2), and (d)(2) of CMS Hospital Conditions of Participation. [416.49(b)(1)]

Q-0203


1. The radiologic services, particularly ionizing radiology procedures, must be free from hazards for patients and personnel. [416.49(b)(1)]

Q-0203 o o

2. Only personnel designated as qualified by the medical staff may use the radiologic equipment and administer procedures. [416.49(b)(1)]

Q-0203 o o

3. Copies of reports and printouts are maintained for at least five years. [416.49(b)(1)] Q-0203 o o

4. Films, scans, and other image records, as appropriate, are maintained for at least five years. [416.49(b)(1)]

Q-0203 o o

References / Notes

• Parts 482.26(b), (c)(2), and (d)(2) of CMS Hospital Conditions of Participation are indicated at Standard 13.D.1-4.

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable



CMS Tag YES NO

E. Health care professionals providing imaging services and/or interpreting results are appropriately trained and privileged.

—


1. Personnel and/or credentials files document appropriate training and credentials. o o

2. There is evidence that such personnel have been granted privileges to provide these services or have job descriptions containing these duties.

o o

3. There is evidence that such personnel have completed appropriate safety training. o o

Compliance Rating



Non-Compliant







CMS Tag YES NO

F. Imaging services provided are appropriate to the needs of patients and support the organization's clinical capabilities.

—


1. Image interpretation is appropriately documented in a timely manner. o o

2. Records or reports of services provided are maintained. o o

3. Observation and interviews indicate that the following are sufficient to ensure the provision of quality services:

o o

a. Space.

b. Supplies.

c. Equipment.

Compliance Rating



Non-Compliant




CMS Tag YES NO

G. Written policies and procedures addressing safety aspects of imaging services are present.

—


1. Written policies and procedures address precautions to safeguard against electrical, mechanical, magnetic, radiation, and other potential hazards.

o o

2. Written policies and procedures require periodic evaluation by qualified personnel of energy sources and of all safety measures followed, including calibration of equipment and testing the integrity of personal protective devices in compliance with federal, state, and local laws and regulations.

o o

Compliance Rating



Non-Compliant







CMS Tag YES NO NA

H. Written policies and procedures address the management of potentially hazardous energy sources.

—


1. Written policies and procedures comply with prevailing laws and regulations for the use, removal, handling, and storage of potentially hazardous materials.

o o

2. Written policies and procedures require proper shielding where radiation and other potentially hazardous energy sources are used.

o o

3. Written policies and procedures include instructions for dealing with accidental hazardous energy exposure.

o o

4. If radiation exposure is monitored, appropriate exposure records are maintained. o o o

5. If radiation exposure is not monitored, documentation exists within the organization to support this decision.

o o o

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant




present



CMS Tag

I. Proper warning signs are in place alerting pregnant females to the presence of hazardous energy fields.

—

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable



CMS Tag

J. Documentation demonstrates that patients are involved in identification of the correct site to be imaged.

—

Compliance Rating



Non-Compliant





Standards 13.K, L, M and N do not apply if the organization only provides peri-operative imaging services.

CMS Tag YES NO

K. Diagnostic imaging services are directed by a qualified physician or dentist. —


1. Documentation of qualifications is present in the credentials file. o o

2. There is evidence that the physician or dentist has been designated by the governing body to hold this responsibility.

o o

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant






CMS Tag YES NO NA

L. Diagnostic imaging tests are performed, authenticated, and documented appropriately.

—


1. Diagnostic imaging tests are performed only upon the order of a health care professional.

o o

2. The order includes the reason for the examination. o o

3. A radiologist authenticates all examination reports. o o o

4. If a radiologist does not authenticate all examination reports: o o o

a. The governing body has determined that specialist physicians or dentists may authenticate reports of specific procedures.

b. Such physicians or dentists have been granted privileges by the governing body or its designee to authenticate these reports.

5. Authenticated, dated reports of all examinations performed are made a part of the patient's clinical record.

o o

References / Notes

• Element 3 does not apply to organizations that function in accordance with Element 4. • Element 4 does not apply to organizations that function in accordance with Element 3.

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant




present






CMS Tag YES NO

M. Diagnostic images are accessible and appropriately retained and stored. —


1. A policy addresses: o o

a. The storage of diagnostic images.

b. The retention of diagnostic images.

2. Diagnostic images are maintained in a readily accessible location for the time required by policy and by any applicable laws.

o o

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant






CMS Tag YES NO

N. If magnetic resonance imaging is conducted, proper warning signs are in place.

—


1. Signs warn patients and other personnel with metal implants. o o

2. Signs warn patients and other personnel with magnetically inscribed credit cards, identification cards, and similar items.

o o

3. Signs warn patients and other personnel wearing metallic objects capable of potentially dangerous motion.

o o

4. Signs warn patients and other personnel with pacemakers, internal defibrillators, cochlear implants, cardiac stents, insulin pumps, or nerve stimulators.

o o

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant




present



153


Chapter 18

Teaching and Publication Activities If staff is involved in teaching or publishing, an accreditable organization has policies governing those activities that are consistent with its mission, goals, and objectives. Such an organization meets the following Standards.

Standards A and B of this chapter apply to organizations with formal teaching agreements with training institutions.

CMS Tag YES NO

A. A current, fully executed written agreement with each training institution is present.

—


1. Each agreement includes a description of the types of students and/or postgraduate trainees eligible for the teaching experience.

o o

2. Each agreement describes the extent to which students and postgraduate trainees are involved in patient care activities.

o o

3. Each agreement includes expectations of students and postgraduate trainees regarding adherence to organizational policies and other regulations.

o o

4. Each agreement indicates whether liability coverage is required and, if so, minimum amounts required.

o o

5. Each agreement describes responsibilities of each party for: o o

a. HIPAA/FERPA training.

b. OSHA training related to bloodborne pathogens.

6. Each agreement includes a requirement that each student or postgraduate trainee signs an addendum to the teaching agreement accepting its terms and conditions.

o o

References / Notes

• Depending on the level of involvement in patient care, credentialing of residents and fellows as described in Ch. 2.II may be appropriate.

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant





present






Chapter 18: Teaching and Publication Activities

CMS Tag YES NO

B. Written policies concerning teaching activities have been adopted. —


1. Written policies address how the identity of the person arriving for training is confirmed.

o o

2. Written policies address requirements for orientation and other training. o o

3. Written policies addressing the provision of health care by personnel with student or postgraduate trainee status include a definition of "close and adequate supervision" of these individuals.

o o

4. Written policies addressing the provision of health care by personnel with student or postgraduate trainee status include the process for obtaining patient consent for student/trainee participation in or observation of the patient's care.

o o

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant




present



CMS Tag

C. If staff is involved in publishing, a written policy specifies approvals needed, if any, of publications attributed to or resulting from care provided by the organization.

—

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable



155


Chapter 19

Research Activities If research is conducted, an accreditable organization establishes and implements policies governing research that are consistent with its mission, goals, and objectives and with its clinical capabilities. Such an organization meets the following Standards.

CMS Tag YES NO

A. Research activities are performed in accordance with ethical and professional practices and legal requirements.

—


1. All research is appropriate for the expertise of the organization's providers and staff. o o

2. Available resources are appropriate for the research conducted. o o

3. Documentation demonstrates that, when reviewing and approving clinical research studies, the governing body reviews any Institutional Review Board (IRB) review completed to ensure that appropriate steps are taken to protect the rights and welfare of patients and others participating as subjects in a research study.

o o

4. Documentation demonstrates that the governing body reviews all current research at least annually.

o o

References / Notes

• Research activities include, but are not limited to, clinical trials of drugs and other biologicals; the use of devices, implants, or instruments that are classified as investigational or experimental; and the use of techniques that are new, experimental, innovative, or otherwise not yet accepted as standard medical or dental practice.

Compliance Rating



Non-Compliant






Chapter 19: Research Activities

CMS Tag YES NO

B. Research is conducted in accordance with established written protocols. —


1. Written protocols for conducting research are present. o o

2. The written protocols for conducting research were approved by the governing body or its designee after medical (or dental) and legal review.

o o

3. There is evidence that professionals involved in research activities are aware of and follow the organization's research protocols.

o o

Compliance Rating



Non-Compliant




CMS Tag YES NO

C. The rights and welfare of all patients participating in research are protected. —


1. Information is available to patients and staff concerning a patient's right to refuse to participate in research.

o o

2. The informed consent of each patient is obtained in the language or manner primarily used by him or her.

o o

3. A research medical record is maintained for each patient participating in research which contains, at minimum:

o o

a. Evidence that the patient has provided informed consent.

b. Name of the study.

c. Start date of the study.

d. Other pertinent information, as applicable to the study.

Compliance Rating



Non-Compliant




157


Chapter 20

Overnight Care and Services If an accreditable ASC in the AAAHC Medicare Deemed Status Program provides overnight care (i.e., has patients that are not discharged from the facility on the same day they were admitted to the facility) and related services, such care and services meet the needs of the patients served and are provided in accordance with ethical and professional practices and legal requirements. The definition of an ASC listed under Title 42 CFR §416.2 includes the language that “Ambulatory surgical center or ASC means any distinct entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization and in which the expected duration of services would not exceed 24 hours following an admission…”.

NOTE: This chapter applies to an ASC that may in a rare circumstance provide care, including overnight accommodations, for patients who do not require the full range of services of an acute care hospital. Such patients may be recovering from surgery and require observation by medical personnel, may be receiving treatment for non-critical illnesses, or may need only short-term or custodial care.

CMS Tag

A. If required by the state, the overnight care unit has obtained a license to operate.

—

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant

Non-Compliant

Not Applicable





Chapter 20: Overnight Care and Services

CMS Tag YES NO

B. Overnight care and services are provided by qualified personnel. —


1. The governing body has appointed one or more qualified physicians to supervise overnight care and services.

o o

2. A patient is admitted or discharged only upon the order of a physician who is responsible for the medical care of that patient.

o o

3. Providers may admit patients to this program if they: o o

a. Are licensed to treat patients or supervise care and services in this setting.

b. Have been granted such privileges by the governing body of the organization, in accordance with AAAHC Standards for credentialing and privileging.

4. There is documented evidence that registered nurses and other health care professionals are appropriately trained.

o o

5. At least one physician is present or immediately available by telephone whenever patients are present.

o o

6. At least one registered nurse is on duty whenever patients are present. o o

Compliance Rating



Non-Compliant






CMS Tag YES NO

C. The scope and limitations of overnight care and services are clearly defined. —


1. Documentation of the scope and limitations of services is present. o o

2. Evidence is present that the scope and limitations of services is communicated to: o o

a. Physicians who refer and admit patients to the program

b. Staff who provide the care and services.

c. Potential patients in advance of their referral to the program.

d. Other health care professionals and relevant community agencies.

Compliance Rating



Non-Compliant







CMS Tag YES NO

D. Written policies and procedures for overnight care are present. —


1. Policies and procedures address clinical criteria for determining eligibility for admission.

o o

2. Policies and procedures address clinical responsibilities for each patient during his/her stay.

o o

3. Policies and procedures address provisions for emergency services. o o

4. Policies and procedures address arrangements for transfer to other health care services as needed.

o o

5. Policies and procedures address staffing requirements to ensure that registered nurses and other health care professionals are available in sufficient numbers to meet patient needs.

o o

6. Policies and procedures address isolation procedures to be followed when any patient is admitted with a suspected or diagnosed communicable disease.

o o

Compliance Rating



Non-Compliant






CMS Tag

E. A written transfer agreement with a nearby hospital is present, or the organization has a written policy of granting admitting privileges only to physicians with admitting privileges at a nearby hospital.

—

Compliance Rating



Non-Compliant





CMS Tag YES NO

F. Clinical record entries reflect the provision of overnight care. —


1. Clinical record entries include a current history and physical examination. o o

2. Clinical record entries include treatment orders. o o

3. Clinical record entries include nursing notes. o o

4. Clinical record entries include follow-up instructions to patients. o o

Compliance Rating



Non-Compliant




CMS Tag YES NO

G. Food service and refreshments are provided to meet the needs of patients. —


1. Evidence of compliance with local, state, and federal guidelines is present with regard to preparing, serving, disposing of, and storing food and drink for patient use.

o o

2. Evidence is present that personnel providing food services meet local health department requirements.

o o

3. Evidence is present that special dietary requirements for patient care are met. o o

Compliance Rating



Non-Compliant




CMS Tag YES NO

H. Provisions are made for patient privacy and safety. —


1. Treatment rooms are provided to meet patient needs and physician requirements. o o

2. Emergency power appropriate for the size of the unit is available. o o

Compliance Rating



Non-Compliant







CMS Tag

I. There is evidence that overnight care and services are reviewed as part of the organization's quality management and improvement program.

—

Compliance Rating



Non-Compliant





163


Chapter 24

Radiation Oncology Treatment Services Radiation oncology treatment services provided by an accreditable organization meet the needs of the patients and are provided in accordance with ethical and professional practices and legal requirements. Such an organization meets the following Standards.

CMS Tag YES NO

A. The governing body has appointed qualified personnel to direct and oversee radiation oncology services.

—


1. The governing body has appointed at least one physician to direct the service. o o

2. The directing physician(s) has been credentialed and privileged to provide radiation oncology services in accordance with AAAHC Standards for credentialing and privileging.

o o

3. The governing body has appointed a radiation safety officer. o o

4. A radiation safety committee meets periodically to review safety issues, policies, etc. o o

5. Documentation is present to demonstrate that a qualified medical physicist conducts at least an annual review of the safety and quality control policies and procedures.

o o

Compliance Rating



Non-Compliant








Chapter 24: Radiation Oncology Treatment Services

CMS Tag YES NO

B. The radiation oncology treatment service employs trained and qualified health care professionals to supervise and perform the services provided.

—


1. Staff includes a radiation technologist certified by the American Registry of Radiologic Technologists (ARRT) or a state-licensed technologist.

o o

2. Staff includes a dosimetrist. o o

3. Staff includes a qualified radiation physicist. o o

4. Staff includes other appropriately trained health care professionals as may be in keeping with local practice and legal requirements, such as oncology nurses, nutritionists, and medical social workers.

o o

5. Observation and interviews confirm that the number of staff is sufficient for the services provided.

o o

Compliance Rating



Non-Compliant









CMS Tag YES NO NA

C. The governing body has adopted written policies addressing the quality of care for radiation oncology.

—


1. Methodologies for diagnosis and treatment are limited to those approved by the governing body.

o o

2. Therapeutic services are performed only upon the written order of a radiation oncologist.

o o

3. A policy for staffing requirements during treatment includes: o o

a. A requirement that a physician be present or immediately available during treatment.

b. A requirement for the presence of qualified support personnel during treatment when a physician is not present.

4. A signed consent form is present in the clinical record prior to treatment. o o

5. Chart and port film for ongoing therapies are reviewed on a weekly basis. o o o

6. Treatment setups are documented with photographs. o o o

7. Emergency treatment is accessible when needed. o o




Non-Compliant









Non-Compliant









Non-Compliant









CMS Tag YES NO

D. Radiation safety processes are followed. —


1. Personnel exposure records are maintained. o o

2. Potentially hazardous materials are acquired, stored, used, handled, and removed in accordance with prevailing laws and regulations.

o o

Compliance Rating



Non-Compliant




CMS Tag YES NO

E. Comprehensive radiation oncology services are provided. —


1. The following services are provided: o o

a. Consultation services.

b. Simulation of treatment.

c. Treatment planning.

d. Clinical treatment management including, but not limited to, the use of teletherapy and/or brachytherapy.

e. Maintenance of reports of services and radiographic images appropriate to the therapy, as required by applicable laws and organization policy.

f. Appropriate follow-up care of all patients.

2. Support services, including diagnostic laboratories and imaging facilities, are accessible as needed.

o o

Compliance Rating



Non-Compliant







CMS Tag YES NO

F. Clinical record entries reflect the provision of radiation oncology treatment. —


1. Clinical record entries include the following: o o

a. Confirmation of the presence of malignancy by histopathology or a statement of benign condition.

b. Definition of tumor location, extent, and stage.

c. Definition of treatment volume.

d. Selection of dose.

e. Selection of treatment modality.

f. Selection of treatment technique.

g. Dosimetry calculations.

2. Supervision of treatment and record of patient progress and tolerance is documented.

o o

3. A summary of completion and statement of follow-up plan is present. o o

Compliance Rating



Non-Compliant




CMS Tag YES NO

G. If High Dose Rate (HDR) brachytherapy, Low Dose Rate (LDR) brachytherapy, or similar procedures using radioactive seeds or other devices that are implanted or injected are used, steps are taken to ensure that no potentially harmful residual radiation is present on site.

—


1. Appropriate storage containers are used. o o

2. The containers and the procedure room are tested for residual radiation as stipulated by the organization's policies.

o o

Compliance Rating

Fully Compliant


Partially Compliant

Minimally Compliant









Tools Accreditation Handbook for Medicare Deemed Status, v41


AAAHC Documentation Requirements

Developing Meaningful Quality Improvement Studies

Sample Application for Privileges

Credentialing Records Worksheet

Clinical Records Worksheet

Personnel Records Worksheet

AAAHC Standards and CMS CfC Related to the Management of Clinical Emergencies

Potential Resuscitation Medications and Equipment

Tools

The 1095 Strong, quality every day philosophy provides ongoing client engagement through valuable

and meaningful tools, resources, and education the help organizations improve the quality and safety of care.


AAAHC Documentation Requirements This tool is designed to help you ensure that you have the written documentation required to comply with v41 AAAHC Standards. Note that Chapters 1–8 apply to all organizations, while the remaining chapters apply only if your organization provides that service. This tool is not meant to be inclusive of all written documentation that your organization may choose or need to maintain, nor does it address additional documentation that CMS may require of Medicare-certified ambulatory surgery centers.

Chap

ter

Standard

Requirement

Instructions: Use the column labeled “Present” to indicate whether a document exists Y = Yes N = No NA = Not Applicable Pr

esen

t

2.I Governance: General Requirements 2.I.C The legally constituted entity is documented

2.I.H.3 Written policy for care of pediatric patients (if pediatric patients are treated) 2.I.I Approving and ensuring compliance of all major contracts

2.I.J.4 Documented evidence that policies, procedures and other information are communicated throughout the organization

2.I.K The governing body keeps minutes or other necessary records 2.I.L Notify AAAHC in writing within 15 calendar days of significant events 2.I.N Documentation demonstrates at least annual governing body review of AAAHC

accreditation requirements 2.II Governance: Credentialing and Privileging

2.II.C, 2.II.D,2.II.E

Requirements for written applications for initial medical or dental staff privileges

2.II.F Written procedures for credentialing 2.II.H Requirements for written applications for reappointment

2.II.G.2 Documentation of delegated responsibility for reviewing the applications, if applicable 2.II.G.4 Appointment and reappointment decisions made by the governing body are

documented 2.II.J The currency of date-sensitive credentialing and privileging information is monitored and

documented 2.II.K.1 Solo provider is required to complete an application or reapplication, and the

documentation identified in Standards 2.II.C, 2.II.D and 2.II.E is present in the credentials file

2.II.K.2 Documentation in the credentials file includes a list of procedures that may be performed, or services that may be provided, by the solo provider

2.II.K.4 Documentation of recommendation regarding granting of privileges for a solo provider 2.II.L.1.a Privileges are granted based on an applicant’s written request for privileges




Chap

ter

Standard

Requirement Instructions: Use the column labeled “Present” to indicate whether a document exists Y = Yes N = No NA = Not Applicable Pr

esen

t

3 Administration 3.A.3 Written job descriptions are present 3.A.4 Documentation indicates that all reasonable steps are taken to comply with applicable

laws and regulations

3.B.2-5 Written policies and procedures for fiscal control 3.C Requirements for written personnel policies 3.E.4 The delivery of all training is documented

4 Quality of Care Provided 4.D.1 Logging and tracking procedures ensure that results for each specimen are obtained 4.G Organization has one of the following:

• A written transfer agreement for transferring patients to a nearby hospital • A written policy of credentialing and privileging physicians and dentists who have

admitting and similar privileges at a nearby hospital • Written agreement with a physician or provider group with admitting privileges at a

nearby hospital • A detailed written procedural plan for handling medical emergencies

5.I Quality Improvement Program 5.I.B Requirements for the written quality improvement program 5.I.G.1 Documentation demonstrates that QI studies include the applicable components 5.I.G.3 Documentation demonstrates that the findings of quality improvement activities are

reported to the governing body and throughout the organization

5.I.J.6 Documentation demonstrates that the results of benchmarking activities are reported to the governing body and throughout the organization

5.II Risk Management 5.II.A, 5.II.B

5.II.C Requirements for written risk management policies

6 Clinical Records and Health Information 6.C Requirements for written policies for clinical records 6.F.1 Written policies require strict confidentiality of information in the clinical record 6.G – 6.N Requirements for the contents of clinical records

7 Chapter 7, Infection Prevention and Control and Safety: Infection Prevention and Control 7.I.A Written program for infection prevention and control 7.I.B Requirements for the written infection prevention and control program 7.I.C.2 Documented evidence of the training and competence of the designated infection

prevention and control professional

7.I.D.3 A written policy addressing the identification and processing of medical equipment and instruments that fail to meet high-level disinfection or sterilization parameters

7.I.D.5 A written process for monitoring and documenting cleaning, high-level disinfection, and sterilization

7.I.E Requirements for the written sharps injury prevention program 7.I.F Written policies and procedures to protect against cross-infection 7.I.H Requirements for written policies address cleaning of patient treatment and care areas. 7.I.I.3 Documented evidence of training and competence of staff responsible for cleaning

devices for use with multiple patients




Chap

ter

Standard


esen

t

7.II Infection Prevention and Control and Safety: Safety 7.II.A Requirements for the written safety program 7.II.B Safety program requires a documented risk assessment for environmental hazards during

demolition, construction, or renovation projects

7.II.C Documentation demonstrates that the risk assessment was conducted or is underway (if applicable)

7.II.D.1 Personnel files include documentation of current BLS certification 7.II.D.2 Documentation of training in the use of cardiac and all other emergency equipment 7.II.E Written policy and process addressing recalls 7.II.F.1 Written policy for the monitoring and disposal of products with expiration dates 7.II.H.2 Documentation demonstrates that temperature monitoring occurs 7.II.H.4 Documentation and/or interviews confirm that staff performing monitoring function have

been trained

7.II.I Written policy requires documentation of pre-cleaning, transport, and handling of medical devices intended for external vendor reprocessing, inspection or repair

7.II.J.1 Documentation demonstrates that reprocessed single-use devices have been approved for reprocessing

7.II.J.2 Documentation that third-party reprocessor is FDA-registered 7.II.J.3 If reprocessing is done in-house, documentation that organization is FDA-registered 7.II.K Instructions to patients regarding the use of medical devices are documented 7.II.N.2 A written exposure control plan 7.II.Q Work injuries and illnesses are appropriately documented

8.I Facilities and Environment 8.I.A Documentation of compliance with applicable building codes and regulations 8.I.B.1 Written policies addressing safety and security practices are present 8.I.L.1-2 Written policies and procedures for medical equipment maintenance 8.I.N.3 Documentation of periodic calibration according to manufacturer's specifications is

present (if equipment requiring calibration is used)

8.I.N.4 Documentation of preventive maintenance according to manufacturer's instructions is present

8.I.P.4 Written evaluations of emergency drills 9 Anesthesia Care Services 9.D Requirements for written policies and procedures for anesthesia services 9.H Requirements for clinical record entries regarding the administration of anesthesia 9.J The oxygenation, ventilation, and circulation of the patient is continually evaluated and

documented.

9.K Written policy regarding assessment and management of acute pain 9.M Written policy regarding medical discharge 9.N.1 Documentation of current ACLS training 9.O.1 Written treatment protocols related to malignant hyperthermia if triggering agents are

present




Chap

ter

Standard


esen

t

9.O.3 Malignant hyperthermia treatment protocols are posted or immediately available 9.O.4 Documentation of education and training in the recognition and treatment of malignant

hyperthermia if triggering agents are present

9.O.5 Documented malignant hyperthermia drills at least annually when triggering agents are present

9.P Written policy regarding the administration of moderate or deep sedation or general anesthesia

9.P.2 Clinical records demonstrate the policy is followed 9.R Written protocol in the event that a deeper-than-intended level of sedation occurs 9.S.1 Documentation of current PALS training and certification if pediatric patients are served 9.S.3 Documentation of training in age- and size-appropriate resuscitative equipment if

pediatric patients are served

10 Surgical and Related Services: General Requirements 10.I.G Documentation of discussions with patient and written informed consent 10.I.I Written policy requiring the presence of personnel qualified to address medical

emergencies whenever patients are present

10.I.J Written policies regarding procedures and treatments offered to patients 10.I.K Written policies and procedures if blood replacement may be required 10.I.L.1 Written protocols for handling, maintenance, and storage of blood and blood products 10.I.L.2 Written protocols for handling, maintaining and storing human cells for transplantation 10.I.M Written policy related to deep vein thrombosis 10.I.N Written policies defining appropriate pediatric care, if provided 10.I.P Requirements for written policies to safeguard against cross-infection 10.I.Q Requirements for written policies for sponge and instrument counts 10.I.R.1 Written procedure verification policy 10.I.R.3 Procedure verification is documented in the clinical record 10.I.S.1-2 Written policy for site marking includes definition of “surgical team” 10.I.S.5 Site marking is documented in the clinical record 10.I.U Findings and techniques of procedure are accurately and completely documented

immediately after the procedure

10.I.U.5.a Tissues removed during surgery are examined by pathologist unless exempted in writing 10.I.V Written guidelines for the transition of care from one provider to another

10.II Surgical and Related Services: Laser, Light-Based Technologies, and Other Energy-Emitting Equipment

10.II.B Requirements for written policies and procedures for each laser present 10.II.C.7 Maintenance logs confirm inspection and testing of devices 10.II.E.3 Patient education regarding procedure risks and complications is documented in the

informed consent

10.III Surgical and Related Services: Renal Lithotripsy Services 10.III.B.1.b Documentation of staff education, including orientation to equipment 10.III.B.2 Documentation of staff training, education and evaluation of personnel if outside providers

of lithotripsy services are used

10.III.C Written policies and procedures for lithotripsy treatment




Chap

ter

Standard


esen

t

10.III.D Written policies for the provision of lithotripsy services 10.III.E Written policies addressing the safety aspects of lithotripsy treatment 10.III.F Requirements for clinical record entries

11 Pharmaceutical Services 11.C Documentation demonstrates that patients are not required to use a pharmacy owned or

operated by the organization

11.D.1-2 State licensure and DEA certification are posted, as applicable 11.G.1 Current contract if pharmaceutical services are made available through a contractual

agreement

11.G.2 Documentation demonstrating that the pharmacy contractor is appropriately licensed and/or certified

11.H Written policy for monitoring medication inventory; documentation of training and of monitoring activities

11.I.1, 11.J.1

Lists of high-alert medications and those with confused drug names currently present in the facility

11.K.2 Pre-signed and/or post-dated prescriptions prohibited by written policy 11.M.1 Written policy addresses the labeling of medications not immediately administered 11.N Written policy addresses the disposal or return of expired, damaged, and recalled

medications

11.O.2 Documentation of staff training in the use of mechanical devices for medication delivery 11.P.2-3 Written policies and procedures for vaccine storage and handling 11.P.4 Documentation of staff training on policies and procedures for safe vaccine handling and

administration

12 Pathology and Medical Laboratory Services 12.D As appropriate for services performed, organization has obtained a Certificate of Waiver,

and/or a Certificate for Provider-Performed Microscopy, and/or a CLIA Certificate of Registration, Compliance or Accreditation

12.F State medical laboratory license or certificate appropriate for the level of testing performed, if applicable

12.I.1 Documented competency tests for staff with laboratory responsibilities 12.J.3 Test results are documented in the patient’s medical record 12.K Test results are reviewed and acknowledged in writing (manually or electronically) 12.L.2 The results of quality control procedures are documented 12.O Complete written descriptions of each test procedure performed are available

13 Diagnostic and Other Imaging Services 13.E.1 Personnel and/or credentials files document appropriate training and credentials 13.F.1 Image interpretation is appropriately documented 13.F.2 Records or reports of services provided are maintained 13.G Written policies addressing safety aspects of imaging services 13.H Written policies addressing potentially hazardous energy sources 13.I, 13.N Proper warning signs are in place




Chap

ter

Standard


esen

t

13.J Documentation demonstrates that patients are involved in identification of the correct site to be imaged

13.K.1 Documentation of qualifications of directing physician or dentist 13.L Diagnostic imaging tests are performed, authenticated and documented appropriately

18 Teaching and Publication Activities 18.A Current written agreement with each training institution 18.B Written policies concerning teaching activities 18.C Written policy regarding publishing activities

19 Research Activities 19.A.3 Documentation that governing body reviews Institutional Review Board results 19.A.4 Documentation of annual governing body review of current research 19.B Research is conducted in accordance with written protocols 19.C.3 A research medical record is maintained

20 Overnight Care and Services 20.A License to operate, if required 20.B.4 Documented evidence that health care professionals are appropriately trained 20.C.1 Documentation of the scope and limitations of service 20.D Written policies and procedures for overnight care 20.E Written transfer agreement with a nearby hospital (or privileges granted only to physicians

with admitting privileges at a nearby hospital)

20.F Requirements for clinical record entries 24 Radiation Oncology Treatment Services 24.A.5 Documentation of annual review of safety and quality control policies and procedures by

a qualified medical physicist

24.C Written policies for the quality of care

24.E.1.e Maintenance of reports of services and radiographic images 24.F Requirements for clinical record entries



Developing Meaningful Quality Improvement Studies Organizations seeking accreditation are expected to maintain an active, integrated, organized, ongoing, data-driven program of quality management and improvement. The chart below assumes that you have an existing, written program (Standard 5.I.A). It is intended to help you use existing monitoring activities (Standard 5.I.C) to generate QI studies (Standard 5.I.D) that will result in meaningful organizational improvement. PART I: COLLECT DATA

Don’t stop here. Put your data to work for you; go to Part II



Developing Meaningful Quality Improvement Studies PART II: COMPARE PERFORMANCE

Don’t stop here. Put your data to work for you; go to Part III

PART III: SOLVE THE QUALITY EQUATION




PART IV: BUILDING A QI STUDY



Developing Meaningful Quality Improvement Studies The following template is designed to help you through the process of documenting a QI

study in your organization using ten distinct elements. The individual items are not meant to be steps completed in order, but elements that should be included in written review of the problem and how it was solved in a way that will be sustainable going forward. Feel free to photocopy these pages for use with multiple studies.

Elem

ent 1

Description Hints for Getting Started

A statement of the purpose of the QI activity that includes a description of the known or suspected problem, and explains why it is significant to the organization

1. Briefly state your known or suspected problem 2. Describe why it is important for your organization to address this problem

Use the space below to state the purpose of the QI study you are conducting, and to describe why it is important for your organization to address this problem

Elem

ent 2


Identification of the performance goal against which the organization will compare its current performance in the area of study

Determine and describe the level of performance your organization wants to achieve in the area of study. For example, if you are studying medication error rates, your goal might be to have zero medication errors. If you are studying rates of compliance with a particular policy, your goal might be 100% compliance. Before setting your goal, it is often useful to determine if there are internal or external benchmarks available to help you decide on a goal that is both realistic and constructive. Zero occurrences or 100% compliance may not be realistic for every issue you study.

Use the space below to identify the performance goal for the QI study you are conducting




Elem

ent 3


Description of the data that have been or will be collected in order to determine the organization’s current performance in the area of study

Determine the following: 1. What data is needed in order to verify:

• Whether the problem actually exists (if this is uncertain) • Frequency and severity of the problem expressed as a number or percentage • Source(s) of the problem

2. How will the data be collected? For example, if you are studying medication error rates, what information do you need in order to determine your current error rate? How will you collect that information?

Use the space below to describe the data you will collect for the QI study you are conducting, and how you will collect it

Elem

ent 4


Evidence of data collection Describe the data you actually collected. For example, did you review X number of charts for patient visits that occurred from Month A to Month F? What did you look at in those charts? What information did you extract from them? How did you record the data that you collected? At this point you are not trying to describe your conclusions about the data — just the data itself.

AFTER YOU HAVE COLLECTED THE DATA FOR THE QI STUDY, use the space below to briefly describe the data collected.




Elem

ent 5


Data analysis that describes findings about the frequency, severity, and source(s) of the problem(s)

1. Carefully analyze the data you have collected. (The complexity of the analysis you need to do will depend on various factors, such as the amount and type of data you have collected.)

2. Determine what the data tells you about whether the suspected problem actually exists. Describe how the data was analyzed and your findings (conclusions) regarding whether or not the problem exists.

3. If the problem DOES exist, determine what the data tells you about the frequency, severity, and source(s) of the problem(s).

4. If the problem DOES NOT exist, then choose another known or suspected problem and begin again.

Use the space below to briefly record your findings for the QI study you are conducting

Elem

ent 6


A comparison of the organization’s current performance in the area of study against the previously identified performance goal

Compare the results of your data analysis to the performance goal you identified in Element 2. For example, if the data indicates that you currently have 65% compliance and the goal is 90% compliance, a simple statement to that effect is sufficient.

Use the space below to briefly state your comparison of current performance vs. goal for the QI study you are conducting

Elem

ent 7


Implementation of corrective action(s) to resolve identified problem(s)

1. Based on what you have learned about the frequency, severity, and source(s) of the problem(s), determine what corrective action(s) you will take to improve your performance in the area of study.

2. Implement the selected corrective action(s) and determine the appropriate length of time until re-measurement is to occur.

Use the space below to describe what corrective action(s) were taken for the QI study you are conducting, including how the corrective actions were implemented




Elem

ent 8


Re-measurement (a second round of data collection and analysis) to objectively determine whether the corrective actions have achieved and sustained demonstrable improvement

1. At the designated re-measurement time, repeat the steps shown for Elements 4 and 5 2. Compare the results of your second round of data collection and analysis to the

performance goal you identified as Element 2, and determine whether the corrective actions have achieved the desired performance goal

Use the space below to describe the second round of data collected and how you collected it. Also state your comparison of the new current performance vs. goal for the QI study you are conducting

Elem

ent 9


If the initial corrective action(s) did not achieve and/or sustain the desired improved performance, implementation of additional corrective action(s) and continued re-measurement until the problem is resolved

1. Determine whether this step is applicable to the study you are conducting. If you have met and are sustaining your performance goal, this step does not apply

2. If this step does apply, repeat the steps shown for Elements 7 and 8 until your performance goal has been achieved in a sustainable manner

Use the space below to indicate whether this step applies to the QI study you are conducting. If it applies, describe what additional corrective action(s) were taken for the QI study you are conducting, including how the corrective actions were implemented. Also describe the additional round of data collected and how you collected it, and state your comparison of the new current performance vs. goal for the QI study you are conducting

Elem

ent 1

0 Description Hints for Getting Started

Communication of the findings of the quality improvement activities: § to the governing body § throughout the organization, as

appropriate

1. Report your QI study and its results to your governing body. Ensure that the governing body’s review of the report is appropriately documented

2. Determine who else in the organization needs to know about the results of the study. Communicate the findings to those people, and document that this has occurred

3. Determine whether other educational activities of the organization should reflect the findings of the study. If so, take appropriate steps to have this occur

Use the space below to describe how the results of the study will be reviewed by the governing body, and how this review will be documented. Also describe other groups that will be notified of the study’s results, and how this notification will take place, and educational activities that will take place as a result of this study



Sample Application for Privileges Organizations are expected to develop an application document appropriate to the operations and services provided. This is a sample document for reference only.

Organization Name Street Address

City State Zip Instructions 1. Information must be typed or printed.

2. All questions must be answered and forms must be signed where indicated. Please initial the bottom of each page of this application.

3. If more space is needed, please attach additional sheets and reference the questions being answered.

4. If there is a break in the continuity of your medical education, internship, residency, hospital affiliations, medical practice, etc., please explain.

5. Please return the following with your application:

a. Curriculum vitae b. Copy of your current state license c. Current IRS W-9s, if applicable d. Copy of narcotic registration (federal/state) (DEA and CDS) e. Request for Privileges (completed and signed) f. Copy of declarations page of professional liability insurance policy

including applicant’s name, effective date, expiration date, and policy limits g. Copy of Board Certification (if applicable) h. Copy of professional school/diploma, residency certificates, and

Fellowship certificates i. Copy of hepatitis-B vaccination or waiver j. Copy of most recent tuberculosis PPD test, if applicable

Identifying Information - - Last Name Jr, Sr, etc. First Name Middle Name SSN List other name(s) by which you have been known

Last Name(s) First Name(s) Middle Name Primary Professional Group and Address Years Associated (YYYY-YYYY) City State Zip Telephone Number Fax Number Email Address Home Address Home Phone Number City State Zip Alternate Phone Number Date of Birth Place of Birth Citizenship Physician Providing Coverage Phone Number Cell Phone Email Medicare Unique Provider ID Number NPI Number Medicaid Number Fax Number

Page 1 of 8 Applicants Initials Date





City State Zip Medical Licensure/Certification State License Number Original Date of Issue (MM/DD/YYYY) Expires (MM/DD/YYYY) Controlled Substances Certification Number (Your State Name) Expires (MM/DD/YYYY) DEA Registration Number Expires (MM/DD/YYYY)

Other State Medical Licenses—Past & Present Do you currently practice

in this state? o Yes o No Explain

State License Number Original Date of Issue (MM/DD/YYYY)

Pre-Medical Education College / University Degrees/Honors Address Date of Graduation

(MM/DD/YYYY)

City State Zip

Medical Education Medical / Professional School Degrees/Honors Address Date of Graduation

(MM/DD/YYYY)

City State Zip

Other Professional Education Name of Institution Degrees/Honors Address Date of Graduation

(MM/DD/YYYY)

City State Zip

Internship Name of Institution Dates Attended (MM/DD/YYYY-MM/DD/YYYY) Address Full Name of Program Director or Department Chair City State Zip Kind (e.g., Medical, Surgical)

Program successfully completed? If no, attach an explanation…………………………………………………………………………… o Yes o No

o Rotating o Straight If straight, list specialty:

Were you the subject of any disciplinary actions during your attendance at this institution? If yes, attach an explanation ………… o Yes o No

o If more than one internship, check here and attach additional information including responses to the above items specific to the additional internships.






City State Zip

Residency Programs

Name of Institution Dates Attended (MM/DD/YYYY-MM/DD/YYYY) Address Full Name of Program Director or Department Chair City State Zip Type of Residency Program successfully completed? If no, attach an explanation…………………………………………………………………………… o Yes o No

Name of Institution Dates Attended (MM/DD/YYYY-MM/DD/YYYY) Address Full Name of Program Director or Department Chair City State Zip Type of Residency

Program successfully completed? If no, attach an explanation…………………………………………………………………………… o Yes o No

Training, Fellowships, Preceptorships & Post Graduate Education List in chronological order. Give complete school or hospital name and address, including ZIP code, beginning and ending dates, and name of your immediate superior.

Name of Institution Dates Attended (MM/DD/YYYY-MM/DD/YYYY)

Address Name of Immediate Superior

City State Zip Type of Fellowship

Program successfully completed? If no, attach an explanation……………………………………………………………………………… o Yes o No

Were you the subject of any disciplinary actions during your attendance at this institution? If yes, attach an explanation …………… o Yes o No



City State Zip Type of Fellowship Program successfully completed? If no, attach an explanation…………………………………………………………………………………… o Yes o No

Were you the subject of any disciplinary actions during your attendance at this institution? If yes, attach an explanation ………….……. o Yes o No



City State Zip Type of Fellowship

Program successfully completed? If no, attach an explanation…………………………………………………………………………………… o Yes o No

Were you the subject of any disciplinary actions during your attendance at this institution? If yes, attach an explanation ……………..… o Yes o No






City State Zip

Hospital & University Affiliations List all present and past affiliations in chronological order. Indicate “Membership Status” as: Active/Courtesy, etc., or Academic Title. Use additional sheets if necessary.

Name of Institution (1) Dates Affiliated (MM/DD/YYYY-MM/DD/YYYY)

Address Membership status (Active, Courtesy, Consulting, Adjunct, Suspended / Terminated/Resigned, Active Professional Staff, Senior Staff, Associate, Provisional, Affiliate, Pending, Other [specify])

City State Zip Department Chief / Chair (Full Name)

Department/Division

Do you currently have privileges at this institution?…………..…………………………………………………………………………………… o Yes o No

If yes, please list the type of privileges granted (e.g., Provisional, Limited, Conditional)


Address Membership status (Active, Courtesy, Consulting, Adjunct, Suspended/Terminated/Resigned, Active Professional Staff, Senior Staff, Associate, Provisional, Affiliate, Pending, Other [specify])


Department/Division






Department/Division






Department/Division








City State Zip

Previous Group / Medical Practice

Name of Organization (1) Type of Organization Dates Practicing (MM/DD/YYYY-MM/DD/YYYY)

Address City State Zip





Certification

Certified by American Board of (Specialty) Certification # Dates of Certification/Recertification/Expiration (MM/DD/YYYY-MM/DD/YYYY)

Subspecialty Board Status (Name of Board Certification # Dates of Certification/Recertification/Expiration (MM/DD/YYYY-MM/DD/YYYY)

If Not Certified, Give Present Status Date Date of Exam

Professional Societies, Awarded Fellowships (e.g., ACS, ACP) List all memberships past, present, or pending in professional societies. Please include dates of membership. Please give complete names and addresses, including ZIP codes in all instances. Attach additional sheets if necessary.






City State Zip

Professional Peer References List three professional references familiar with the applicant’s qualifications during the three years immediately preceding this application. One professional reference must be from the Chief of the department or service where the applicant last furnished professional services.

Last Name (1) First Name Middle Name Degree Title Professional Relationship

Specialty Years Known


Phone Email Fax




Phone Email Fax




Phone Email Fax

Professional Liability

Insurance Carrier Policy Limits Per Occurrence ($) Aggregate ($)


Policy # Agent Effective Date (MM/DD/YYYY) Expiration Date (MM/DD/YYYY)

Type of Coverage o Claims Made o Occurrence

Have any professional liability lawsuits been filed against you during the past ten years (including those closed?......... o Yes o No

Are there any now still pending?....................................................................................................................................... o Yes o No

Has any judgment, payment of claim, or settlement ever been made against you in any professional liability cases?.... o Yes o No

Has any judgment or payment of claim or settlement amount exceeded the limits of this coverage?.............................. o Yes o No

Have you ever been denied professional insurance, or has your policy ever been canceled?…………………………….. o Yes o No

If yes to any of the above, please explain on a separate sheet.






City State Zip

Professional Sanctions 1. Has your license to practice in any jurisdiction ever been denied, restricted, limited, suspended, revoked, canceled, and/or

subject to probation either voluntarily or involuntarily, or has your application for a license ever been withdrawn? o Yes o No

2. Have you ever been reprimanded and/or fined, been the subject of a complaint, and/or have you been notified in writing that you have been investigated as the possible subject of a criminal, civil, or disciplinary action by any state or federal agency that licenses providers?

o Yes o No

3. Have you lost any board certification(s), and/or failed to rectify (may not apply)? o Yes o No

4. Have you been examined by a Capital Certifying Board but failed to pass (may not apply)? o Yes o No

5. Has any information pertaining to you, including malpractice judgments and/or disciplinary action, ever been reported to the National Practitioner Data Bank (NPDB) or any other practitioner data bank? o Yes o No

6. Has your federal DEA number and/or state controlled substances license been restricted, limited, relinquished, suspended, or revoked, either voluntarily or involuntarily, and/or have you ever been notified in writing that you are being investigated as the possible subject of a criminal or disciplinary action with respect to your DEA or controlled substance registration?

o Yes o No

7. Have you, or any of your hospital or ambulatory surgery center privileges and/or memberships been denied, revoked, suspended, reduced, placed on probation, proctored, placed under mandatory consultation, or non-renewed? o Yes o No

8. Have you voluntarily or involuntarily relinquished or failed to seek renewal of your hospital or ambulatory surgery center privileges for any reason? o Yes o No

9. Have any disciplinary actions or proceedings been instituted against you and/or are any disciplinary actions or proceedings now pending with respect to your hospital or ambulatory surgery center privileges and/or your license? o Yes o No

10. Have you ever been reprimanded, censured, excluded, suspended, and/or disqualified from participating, or voluntarily withdrawn to avoid an investigation, in Medicare, Medicaid, CHAMPUS, and/or any other governmental health-related programs?

o Yes o No

11. Have Medicare, Medicaid, CHAMPUS, PRO authorities, and/or any other third-party payors brought charges against you for alleged inappropriate fees and/or quality-of-care issues? o Yes o No

12. Have you been denied membership and/or been subject to probation, reprimand, sanction, or disciplinary action, or have you ever been notified in writing that you are being investigated as the possible subject of a criminal or disciplinary action by any health care organization, e.g., hospital, HMO, PPO, IPA, professional group or society, licensing board, certification board, PSRO, or PRO?

o Yes o No

13. Have you withdrawn an application or any portion or an application for appointment or reappointment for clinical privileges or staff appointment or for license or membership in an IPA, PHO, professional group or society, health care entity, or health care plan prior to a final decision to avoid a professional review or an adverse decision?

o Yes o No

14. Have you been charged with or convicted of a crime (other than a minor traffic offense) in this or any other state or country and/or do you have any criminal charges pending other than minor traffic offenses in this state or any other state or country? o Yes o No

15. Have you been the subject of a civil or criminal or administrative action or been notified in writing that you are being investigated as the possible subject at a civil, criminal, or administrative action regarding sexual misconduct, child abuse, domestic violence, or elder abuse?

o Yes o No

16. Have you had a refusal or cancellation of professional liability coverage? o Yes o No


Health Status 1. Do you have a medical condition, physical defect, or emotional impairment which in any way impairs and/or limits your ability to

practice medicine with reasonable skill and safety? o Yes o No

2. Are you unable to perform the essential functions of a practitioner in your area of practice, with or without reasonable accommodation? o Yes o No


Chemical Substance or Alcohol Abuse 1. Are you currently engaged in illegal use of any legal or illegal substances? o Yes o No

2. Do you use any chemical substances that would in any way impair or limit your ability to practice medicine and perform the functions of your job with reasonable skill and safety? o Yes o No







City State Zip Attestation

By applying for clinical privileges, I hereby signify my willingness to appear for interviews in regard to my application, and I authorize the “Organization,” its medical staff, and their representatives to consult with members of management and members of medical staffs of other hospitals or institutions with which I have been associated and with others, including past and present malpractice insurance carriers, who may have information bearing on my professional competence, character, and ethical qualifications. I hereby further consent to inspection by the “Organization,” its medical staff, and its representatives of all records and documents, including medical and credential records at other hospitals, which may be material to an evaluation of my qualifications for staff membership. I hereby release from liability all representatives of the “Organization” and its medical staff, in their individual and collective capacities, for their acts performed in good faith and without malice in connection with evaluating my application and my credentials and qualifications, and I hereby release from any liability any and all individuals and organizations who provide information

to the “Organization” or to members of its medical staff in good faith and without malice concerning my professional competence, ethics, character, and other qualifications for staff appointment and clinical privileges. I hereby consent to the release of information by other hospitals, other medical associations, and other authorized persons, on request, regarding any questions the “Organization” may have concerning me as long as such release of information is done

in good faith and without malice, and I hereby release from liability and hold harmless the “Organization” and any other third party for so doing. I understand and agree that I, as an applicant for clinical privileges, have the burden of producing adequate information for the proper evaluation of my professional competence, character, ethics, and other qualifications and for the resolution of any doubts about such qualifications.

By accepting appointment and/or reappointment to the medical staff at (insert organization name), I hereby acknowledge and represent that I have read and am familiar with the bylaws, rules, and regulations of the “Organization”, as well as the principles, standards, and ethics of the national, state, and local associations and state law and regulations that apply to and govern my specialty and/or profession, which are the “Governing Standards.” I further agree to abide by such further Governing Standards as may be enacted from time to time.

In addition, I agree to notify the “Organization” of any circumstances that would change my status in licensure, DEA, Medicare participation, liability insurance coverage, board certification status, or hospital privileges.

I understand and agree that any significant misstatements in or omissions from this application shall constitute cause for denial of appointment or cause for summary dismissal from the medical staff with no right of appeal. All information submitted by me in this application is true to the best of my knowledge and belief.

I further authorize a photocopy or facsimile of the requests, authorizations, and releases to this application to serve as the original.

Signature of Applicant Date

Print Name






RE: Applicants Name, Title City State Zip

Temporary Privileges o Appointment recommended to the category of ___________________ staff with the following clinical privileges:

o As Requested o As requested with the following changes

o Appointment not recommended

Executive Director Date Medical Director Date

Medical Executive Committee o Appointment recommended to the category of ___________________ staff with the following clinical privileges:



Medical Executive Committee Member Date

Board of Directors o Appointment recommended to the category of ___________________ staff with the following clinical privileges:



Board of Directors Member Date




Organization Name Street Address RE: Applicants Name, Title City State Zip

Reference Letter Dear Sir or Madam:

The above practitioner has applied for medical staff appointment (or clinical privileges) to the staff of (Organization Name). The applicant has given your name as a reference, and we are asking you to render an opinion in the following categories. This is an important part of the evaluation of this practitioner’s application for clinical staff privileges. Your response will be treated as confidential.

Please do not hesitate to call us if you feel your comments could be best expressed directly.

Reliable Usually Reliable Problems

Clinical Knowledge o o o Clinical Judgment o o o Technical Proficiency o o o Professional Relations with Patients o o o Ethical Conduct o o o

Record Keeping o o o

Ability to Understand and Speak English o o o

Participation in Medical Staff Affairs o o o

What is your opinion regarding the applicant’s competency in performing the privileges shown on the attachment?

Additional comments:

Recommendation:

Signature Title Date

Name (Please Print)




Organization Name Street Address RE: Applicants Name, Title City State Zip

Medical Staff Office Reference Regarding the appointment of: Applicant Name, Title

Dear Sir or Madam:

The applicant named above is seeking medical staff privileges at our organization. We would appreciate answers to the questions found below.

This physician’s current staff status:

Questions Yes No Do Not Know

Have this practitioner’s privileges been restricted, suspended, revoked, or surrendered?

o o o

Has this practitioner’s professional performance been within or above the acceptable standard of care within the last two years?

o o o

Has the practitioner’s morbidity rate, mortality rate, infection rate, or complication rate exceeded your organization’s criteria for the standards of practice?

o o o

Has the practitioner been suspended for clinical records violations within the last two years? If yes, how many times?

o o o

Has this practitioner’s behavior been disruptive to patient care? o o o Have there been written complaints about this practitioner by patients, hospital staff, or members of the medical staff?

o o o

Has the practitioner been subjected to any disciplinary action by this hospital or licensing body during the past two years?

o o o

To the best of your knowledge, has this individual been involved in a malpractice claim or action during the past two years? If yes, please provide us with the information regarding the malpractice claim or action during the past two years.

o o o

At the appropriate time, will you likely re-appoint this individual to your medical staff?

o o o

Thank you for your effort and assistance with this request.

Signature Title Date

Name (Please Print)



Instructions Credential Record Identifier

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s Unless otherwise indicated, mark each box below as: Y: Yes N: No NA: Not Applicable

Indicate most recent credentialing cycle: IA = initial application cycle; RA = reappointment cycle. Information recorded below is related to most recent cycle unless otherwise noted

Indicate professional license type for each individual (e.g., MD/DO, APRN, PT); a specific position description suffices for employed providers

2.II.M Is this provider an allied health professional (AHP)? Does the organization have an appointment/reappointment process for AHPs? Y/N If yes, review the organization’s process and determine the following: Is the process consistent with state law? Y/N Does the process include verification of education, training, experience, and current competence? Y/N

Identify and evaluate applicable AAAHC Standards shown below that are required by the organization’s process for AHP credentialing and privileging.

(IA) 2.II.E (RA) 2.II.H

Completed and signed formal application for privileges is present.

(IA) 2.II.F (RA) 2.II.I

Evidence is present demonstrating that primary or secondary source verification of credentials was conducted. (If a CVO was used, see Reference / Note at Standard 2.II.F.)

The following were verified at initial appointment:

2.II.C.1 Education.

Training and/or other relevant experience.

(IA) 2.II.C.2 (RA) 2.II.G.3

Current competence as evidenced by peer references. At reappointment, peer review results/activities were incorporated into the decision process.

Continued on the next page




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The following were verified at initial appointment and at reappointment:

(IA) 2.II.C.3 (RA) 2.II.I

Current state licensure.


NPDB report.


DEA registration, if applicable.


Current medical liability coverage meeting governing body requirements, if any.

(IA) 2.II.D (RA) 2.II.H.2.b

At minimum, applications for initial appointment and reappointment include the following attestations and statements from the applicant: Professional liability claims history.

Refusal or cancellation of professional liability coverage.

Information on licensure revocation, supervision, voluntary relinquishment, licensure probationary status, or other licensure conditions or limitations. Complaints or adverse action reports filed against the applicant with a local, state or national professional society or licensure board. Denial, suspension, limitation, termination or non-renewal of professional privileges at any hospital, health plan, medical group, or other health care entity. DEA and state license actions.

Any Medicare/Medicaid sanctions.

Conviction of a criminal offense other than minor traffic violations.

Current physical, mental health, or chemical dependency problems that would interfere with an applicant’s ability to provide high quality patient care and professional service.

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Credential Record Identifier

(IA) 2.II.E.1-2 (RA) 2.II.H.2.b

Formal statement releasing the organization from any liability in connection with credentialing decisions. Applicant’s attestation to the accuracy and completeness of the application and additional information provided.

2.II.G Documentation demonstrates that the governing body approved initial and reappointment decisions. Privileges were granted based on:

2.II.L.1.a The applicant’s written request for privileges.

2.II.L.1.b Qualifications for the services provided by the organization.

2.II.L.1.c Recommendations from qualified medical or dental personnel, if applicable.

2.II.L.2 Privileges were granted for a specified period of time.

2.II.A416.45Q-0120

Credentialing and privileging processes followed the organization’s policies and procedures, medical staff bylaws, etc.

2.II.A.3 Applications for privileges were processed according to timeframes specified in bylaws and/or policies.

2.II.H416.45(b)Q-0122

Length of appointment follows state law and organization policy. Reappointment occurs at least once every three years or more frequently if required by state law or organization policy.

For Solo Providers:

2.II.K.1 The provider has completed an application/reapplication.

2.II.K.2 The documentation identified in Standards 2.II.C, 2.II.D, and 2.II.E is present in the credentials file. Documentation in the credentials file includes a list of procedures that may be performed, or services that may be provided, in the organization/practice setting.

2.II.K.3 The provider’s credentials file is reviewed by an outside physician or dentist at least every three years, or more frequently if state law or organization policy so stipulate.

2.II.K.4 An outside physician or dentist has reviewed the granting of privileges and provided documentation of his/her recommendation.

Use the Record Identifier and insert comments on the next page.



Record Identifier Comments


Clinical Records WorksheetInstructions

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1.K.1416.50(c)(1)

Q-0224

The patient was provided with written information concerning the ASC’s policies on advance directives, including a description of applicable state health and safety laws and, if requested, official state advance directive forms.

1.K.2416.50(c)(2)

Q-0224

The patient was informed of his/her right to make informed decisions regarding care.

1.K.3416.50(c)(3)

Q-0224

Documentation in a prominent part of the record indicates whether or not the patient has executed an advance directive.

1.J416.50(e)(1)(iii)

Q-02296.G.6

416.47(b)(7) Q-0162

9.E, 10.I.G.2

Documentation of properly executed informed consent.

4.E.2 Appropriate and timely diagnoses are made based on findings of the current history and physical examination.

4.E.3 Medication reconciliation is performed.

4.E.4 Treatment is consistent with clinical impression or working diagnosis.

4.E.5 The record documents appropriate and timely consultation and follow-up of referrals, tests, and findings.

6.D.1 Content and format of the record are uniform and consistent with the clinical records policies.

6.D.2 Clinical record entries are legible, including items that are scanned into an electronic record.

6.D.3 Clinical record entries are easily accessible within the record to the organization’s personnel.

6.G416.47(b)(1)

Q-0162

The record includes appropriate patient identifiers including, at least: name, identification number (if used), date of birth, gender, and responsible

party (if applicable).

6.G.5416.47(b)(6)

Q-0162

Entries related to anesthesia administration.

6.H.1 Date and department (if departmentalized)

6.H.2416.47(b)(2)

Q-0162

Significant medical history and results of physical examination.



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6.H.3416.47(b)(3)

Q-0162

Pre-operative diagnostic studies, entered into the medical record before surgery, if performed.

6.H.4416.47(b)(4)

Q-0162

Clinical findings and techniques of the operation including a pathologist’s report on all tissues removed during surgery, except those exempted by the governing body.

6.H.5 Any changes in prescription and non-prescription medication(s) with name and dosage, when available.

6.H.6416.47(b)(8)

Q-0162

Discharge diagnosis or impression, and disposition, recommendations and instructions given to the patient.

6.H.7 Signature of, or authentication by, the health care professional on the clinical record entries.

6.I.1 The record contains evidence that patients are asked to provide information about allergies and sensitivities at each encounter.

6.I.2 The record contains evidence that patients are asked to provide information about other reactions at each encounter.

6.I.3416.47(b)(5)

Q-0162

Information about allergies, sensitivities and reactions is recorded in a prominent and consistently defined location.

6.I.4 The record contains evidence that information about allergies, sensitivities, and reactions is updated when changes are reported.

6.J There is evidence that reports, histories and physicals, progress notes, and other patient information (such as laboratory reports, x-ray readings, operative reports, and consultations) were reviewed in accordance with policy prior to incorporation into the record.

6.J.2 Reports, histories and physicals, progress notes, and other patient information have been incorporated into the record.

6.J.3 The date that patient information was incorporated into the record is documented in the record.

6.K, 10.I.G.1-2 If applicable, the record documents discussions with the patient concerning the necessity, appropriateness, and risks of proposed care, surgery, or procedure, as well as discussions of treatment alternatives, as applicable.

6.L Any notation in the clinical record indicating diagnostic or therapeutic intervention as part of clinical research is clearly contrasted with entries regarding the provision of non-research related care.

6.M.1 If applicable, the record documents missed and cancelled appointments.

6.M.2 If applicable, the record documents medical advice given by text, email, or by telephone, including medical advice provided after-hours.



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6.M.3 For records with three or more visits/admissions OR complex and lengthy records, a summary of past and current diagnoses or problems, including past procedures, is present.

6.N If applicable, summaries or pertinent records of treatment received elsewhere have been incorporated into the record.

9.G416.42(a)(1)(ii)

Q-0061

Immediately before surgery, a physician or anesthetist examined the patient to evaluate the risk of anesthesia.

9.H.1416.47(b)(6)

Q-0162

If moderate sedation/analgesia, deep sedation/analgesia, regional anesthesia, or general anesthesia is administered, clinical records include entries include the following:

9.H.1.a A pre-anesthesia assessment/evaluation.

9.H.1.b A plan for anesthetic administration

9.H.1.c A chronologic record reflecting the anesthetic administered and clinical status of the patient

9.H.1.d A post-anesthesia assessment/evaluation.

9.H.2 Documentation that anesthesia was administered by an appropriately privileged practitioner.

10.I.E An appropriate and current health history with a list of current medications and dosages (when available), physical examination, and pertinent diagnostic studies are present in the record no more than 30 days prior to the scheduled surgery/procedure (or according to local, state, or federal requirement).

10.I.F.1416.52(a)(2)

Q-0262

Upon admission, each patient must have a pre-surgical assessment completed by a physician who will be performing the procedure or other qualified practitioner in accordance with applicable State health and safety laws, standards of practice, and ASC policy.

10.I.F.2416.52(a)(3)

Q-0262

The pre-surgical assessment includes documentation of any allergies to drugs and biologicals.

10.I.F.3416.52(a)(4)

Q-0263

The patient’s medical history and physical assessment was placed in the patient’s medical record prior to the surgical procedure.

10.I.H416.42(a)(1)(i)

Q-0061

Immediately before surgery, a physician examined the patient to evaluate the risk of the procedure to be performed.

10.I.R.3 Clinical records contain documentation of procedure verification.

Use the File Identifier and insert comments on the next page.



File Identifier Comments


Personnel Records Worksheet Instructions Record Identifier

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Unless otherwise indicated, mark each box below as: Y: Yes N: No NA: Not Applicable

When licensed, indicate the license type (e.g., RN, RT) as part of the record identifier.

2.II.F, I, M Documentation of verification of professional license/certification is present (if applicable).

2.II.J File contains evidence of ongoing monitoring of date-sensitive information, such as licensure or certification.

3.A.2 File contains evidence that the person holds qualifications commensurate with job responsibilities and authority including, if applicable, appropriate licensure or certification.

3.C File contains employment-related items as required by the organization’s personnel policies (e.g., job application, resume, job description, verification of references, results of background check, employee benefit forms).

3.C.2 File contains evidence of periodic performance appraisals including current competence(ies).

3.C.4 File contains evidence that personnel policies were made known to the employee at the time of employment.

3.C.5 Documentation of verification of employment eligibility is present, such as I-9 (Immigration and Naturalization Form) and visa, if applicable. (Note: Organization may choose to keep I-9 forms separate from personnel files.)

3.E.1 Documentation of initial orientation and training within 30 days of hire is present.

Documentation of initial orientation and training indicates that 3.D.1-6 were addressed:

3.D.1 Fire safety and the disaster preparedness plan

3.D.2 The use of emergency, safety and fire extinguishing equipment

3.D.3 The infection prevention and control program, including bloodborne pathogen and other training required by OSHA

3.D.4 The safety program, including exposure control training and sharps injury prevention

3.D.5 The risk management program, including training in the reporting of adverse incidents

3.D.6 Confidentiality and privacy training (e.g., HIPAA, FERPA)

3.E.2 Documentation of annual training is present.

3.E.3 Documentation of as-needed training is present.

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Personnel Records Worksheet

Instructions Record Identifier Re

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Unless otherwise indicated, mark each box below as: Y: Yes N: No NA: Not Applicable

When licensed, indicate the license type (e.g., RN, RT) as part of the record identifier.

7.II.N.3 Evidence is present of employee acceptance/declination of immunization(s) program, based on state and/or organization policy (when applicable).

7.II.O.1 Signed hepatitis-B immunization acceptance/declination is present (when applicable).

7.II.Q.1 Work injuries and illnesses, if any, are documented.

7.II.Q.2 Evidence is present that work injuries and illnesses, if any, were investigated as appropriate for the issue.

7.II.D416.44(e)9.N, 9.S

Evidence of current BLS, ACLS, PALS, ATLS training is present (if required); PEARS training is not accepted in lieu of PALS training.

Record Identifier Comments


AAAHC Standards and CMS CfC Related to the Management of Clinical Emergencies

Level of Anesthesia

Equipment Medication Education Emergency Monitoring Training Drills

None The ASC medical staff and governing body coordinate, develop and revise policies and procedures to specify the types of emergency equipment required for use in the ASC’s operating room(s). (8.I.M.1-5, 416.44(d), Q-0109)

Personnel trained in BLS and the use of cardiac and emergency equipment and supplies are present in the facility when patients are present (7.II.D.1-3, 416.44(e), Q-0110)

A comprehensive written emergency and disaster preparedness plan to address internal and external emergencies (8.II.A, 416.54, E-0002)

Scenario-based drills of the internal emergency and disaster preparedness plan are conducted. (8.I.N)

– At least one drill isconducted each calendar quarter (8.I.N.2)

– One of the quarterlydrills is a CPR technique drill, as appropriate (8.I.N.3)

– A written evaluation ofeach drill is completed (8.I.N.4)

– Any needed correctionsor modifications to the plan are implemented promptly (8.I.N.5)

Local or topical anesthesia

Necessary equipment, e.g., AED (9.F)

Oxygen (9.F.1)

Self-inflating hand resuscitator bag (Ambu bag/mask), adult and/or pediatric (9.F.2, 9.S, 9.T)

As appropriate (9.L.3) As appropriate (9.F.3)

Manufacturer’s printed expiration dates are monitored on a regular basis for all products, including medications. A policy exists for disposal or return of expired medications and supplies. (7.II.F, 11.F [416.48(a), Q-0181], 11.N)

Minimal sedation (anxiolysis)

Moderate sedation/ analgesia (conscious sedation)

Necessary equipment, e.g., AED or defibrillator (9.F)

Oxygen (9.F.1)

Self-inflating hand resuscitator bag (Ambu bag/mask), adult and/or pediatric (9.F.2, 9.S)

Pulse oximeter (9.J.1.a)

BP recorded at frequent intervals (defined by the facility policy) (9.J.1.b))

ECG (9.J.1.c)

Appropriate emergency medications available (9.F.3)

Additional medications, as appropriate, for pediatric patients (9.T)

Manufacturer’s printed expiration dates are monitored on a regular basis for all products, including medications. A policy exists for disposal or return of expired medications and supplies. (7.II.F, 11.F [416.48(a), Q-0181], 11.N

All clinical support staff with direct patient contact will be BLS-trained (7.II.D.1-3, 416.44(e), Q-0110) and an ACLS-trained health professional will be present until all patients operated on that day have been physically discharged (9.N.1-3)

PALS-trained health professional needed for pediatric patients (9.S)

The organization has a written protocol for safe and timely transfer of patients to a local Medicare participating hospital (4.H, 4.I, 416.41(b)(3), Q-0042)

Regional anesthesia

Deep sedation/ analgesia


BP recorded at frequent intervals (defined by the facility policy) (9.J.1.b)

ECG (9.J.1.c)

Monitoring for exhaled CO2 (9.J.2)

General anesthesia


BP recorded at frequent intervals (defined by the facility policy) (9.J.1.b)

ECG (9.J.1.c)

End-tidal CO2 monitoring (9.J.3)

Measurement of body temperature (9.J.4)


Potential Resuscitation Medications and Equipment (Items that MAY be Appropriate)

• The AAAHC Standards do not mandate requirements for the contents of a crash cart.• Many states DO have requirements for such equipment and medications. Review your state

requirements.• The contents of a crash cart are dependent on the risk factors of the patient (surgical and medical), the

type(s) of anesthesia used, and the ability of providers to carry out the ACLS protocol, where applicable.• In accordance with Standard 11.K, drugs on a crash cart must be secured. Contents of the cart should be

immediately replaced after use in order to assure availability for future emergencies (Standard 8.I.M.1-5)and to maintain compliance with state requirements, where applicable.

Potential Equipment Respiratory Cardiac IV access

• Suction source (with suction tubing andYankeur tip)

• Self-inflating hand resuscitator (Ambubag/mask); adult and pediatric, if needed

• Oxygen tubing• Oxygen mask, nasal cannula• Oxygen• Laryngoscopes (blades of various sizes and

short/long handles)• Endotracheal tubes of various sizes (cuffed and

uncuffed)• Oral/nasal airways• Supralaryngeal devices• McGill forceps• Tongue blades, tape

• Monitor/defibrillators (AEDs)• ECG electrodes• Defibrillation pads• Stethoscope

• Intravenous access kit• IV catheters of various

sizes• IV tubing• Crystalloids• Alcohol preps, gauze, tape,

tourniquet• Syringes of various sizes• Stopcocks

Potential Resuscitative Medications Intubation Medications

(Rapid Sequence) ACLS

Recommended Medications*

Other Medications (Condition-related and Antagonists)

• Succinylcholine(refrigerated) or anotherparalytic such asRocuronium (refrigerated).If Succinylcholine isavailable, Standards9.O.1-5 apply, includingDantrolene.

• Broselow tape orconversion chart (pediatricpatients)

• Atropine• Epinephrine• Amiodarone• Vasopressin

• Adenosine**• Midazolam**• Magnesium

Sulfate**• Calcium (chloride

or gluconate) **• Hydrocortisone**• Dopamine**• Norepinephrine**

• Dextrose**• Glucagon• Nitroglycerin**• Aspirin**

• Naloxone• Flumazenil• Diphenhydramine

*This is NOT a complete list of all ACLS recommended medications. For a complete list, refer tohttp://acls-algorithms.com/acls-drugs.**Also on the ACLS recommended medication list.

Physical Environment Checklist (PEC)



Standards, Characteristics, and Requirements for Ambulatory Surgical Centers in Conformance with CMS CfC

1. Facility Background Information2. Construction/General3. Means of Egress4. Laboratory-Related Requirements5. Vertical Opening Protection6. Hazardous Area Protection7. Medical Gases8. Electrical System9. Interior Finish10. Fire Alarm Systems11. Corridor Separation12. Smoke and Fire Protection13. Portable Fire Extinguishers14. High-Rise Buildings15. Building Services16. Vertical Conveyors17. Fire Emergency Plans18. Smoking19. Furnishings and Decorations

Life Safety Code (LSC) Plan of Correction (PoC)

Physical Environment Checklist (PEC)

WEL Designs PLC and AAAHC are not responsible for improper, incomplete, or out-of-context application of this document. Any individual or ASC using this PEC does so with an expressed understanding that all regulations and standards are subject to interpretation by authorities having jurisdiction — neither WEL Designs PLC nor AAAHC make any assurance as to the acceptability of interpretations necessarily contained in this PEC to any other authority. Life Safety Code® and NFPA 101® are registered trademarks of the National Fire Protection Association, Quincy, Massachusetts. The use or application of this PEC by anyone, including design or construction professionals, as a replacement or substitute for actual NFPA documents is strictly prohibited.

© Copyright 2010 by WEL Designs, PLC (http://www.WELdesigns.com) All rights reserved.


Physical Environment Checklist (PEC) This PEC provides a format for schematic review of the fire and life safety issues required for Ambulatory Surgery Centers (ASCs) desiring certification by the Centers for Medicare and Medicaid Services (CMS). It is based on requirements of applicable National Fire Protection Association (NFPA) codes and standards, and mandated by CMS for Medicare Certified ASCs, as referenced from the 2012 edition of the NFPA 101® Life Safety Code®, the 2012 edition of NFPA 99 Health Care Facilities, and therefrom referenced editions of NFPA 10, NFPA 13, NFPA 14, NFPA 30, NFPA 37, NFPA 50, NFPA 70, NFPA 72, NFPA 80, NFPA 110, NFPA 111, NFPA 267, and NFPA 701.

Introduction In an effort to simplify the complex task of evaluating conformance with a vast array of publications, requirements from various related NFPA standards are combined in many of the PEC’s items and sections. This necessarily involves interpretation of many NFPA requirements, and consequently may appear to exceed or circumvent the obvious intent of any single reference to a specific standard.

This PEC is not represented as a comprehensive summary of, or replacement for, NFPA codes and standards, and shall not be used or construed as such. Rather it is a summary of the visual manifestations of NFPA compliance, and is most useful as a tool for identifying obvious weakness or oversight in the design, engineering, or construction of an ASC.

It is possible a facility in full conformance with the items in this PEC may not satisfy all applicable requirements of the NFPA codes. Final determination of the regulations applicable to any given facility, and the official interpretation of such regulations, is the responsibility of local, state, and federal authorities having jurisdiction over the ASC. Individuals and ASCs desiring more complete and accurate information, and all design and construction professionals, are directed to such authorities and to the actual text of all the applicable National Fire Protection Association codes and standards.

General Notes For a health care facility to be classified as “ambulatory” it must NOT: 1) provide sleeping accommodations for occupants, 2) be occupied by persons who are mostly incapable of self-preservation (either prior to or following treatment in the facility). If either or both of the above are true, the facility is considered a non-ambulatory health care facility and will be regulated like a hospital, nursing home, or other health care setting providing overnight care.

Each requirement and supporting item of this PEC is followed by three compliance status boxes. Requirements considered fundamental to compliance offer choices of “C” for compliant, “NC” for non-compliant and, in many cases, “NA” for not applicable. Items of detail that substantiate adherence to a preceding requirement are followed by “Y” for yes, “N” for no, and, in many cases, “NA” for not applicable. Where “NA” is not given as a choice, a dashed empty box exists in its place, and the requirement, or item of detail, is applicable in all cases.

NOTE: A reference to regulatory documents and standards used as the basis for each requirement’s summary description appears at the end of each section or group of requirements in blue. In all cases, design professionals and regulatory authorities should refer to the actual NFPA documents and standards for additional and more comprehensive information. Section 1 collects information vital to the identification of an ASC as EXISTING or NEW and details that allow for the correct application of the requirements described in this document. On-site surveys will verify compliance with applicable standards. Each survey is a snapshot in time and therefore, previous instances of deficiencies that were not cited are not considered compliant findings.

CMS references relate to CMS survey Form CMS-2786U (05/2018), Previous Versions Obsolete EF 11/2005. References to NFPA 101® relate to the 2012 Edition, per CMS mandate. References to NFPA 99 relate to the 2012 edition, per CMS mandate.


Physical Environment Checklist

NOTE Condition for Coverage 416.44 – Physical Environment requires review of the physical plant aspects as well as operational capabilities related to safe delivery of patient care. Standards under the CfC 416.44 Physical Environment are reviewed using the requirements outlined in AAAHC Chapter 8 – Facilities and Environment and in the Physical Environment Checklist (PEC).

This PEC is intended to be a resource for ASCs required to meet Life Safety and Health Care Facilities Code requirements.

Facilities that qualify as NEW (built or permits approved after July 5, 2016) will be surveyed under requirements applicable to NEW facilities/systems under the 2012 edition of the LSC and Health Care Facility Code. Facilities that fall under EXISTING requirements will need to verify that the facility and its systems are in compliance with the edition of the NFPA Codes/Standard that adopted by CMS at the time they were installed or previously altered, renovated, or modernized. Life Safety surveyors will verify compliance with requirements applicable to the surveyed ASC.

This PEC is not represented as a comprehensive summary of, or replacement for, NFPA codes and standards, and shall not be used or construed as such. It is entirely possible that a facility in full conformance with the items in this PEC may not satisfy all applicable requirements of the NFPA codes. If a surveyor identifies additional items from the applicable NFPA codes and standards with which the facility is not in compliance, or which are of specific concern, such items will be documented in the Survey Report.

Acronyms

ABHR Alcohol-based Hand Rub

ATS Automatic Transfer Switch

ECE Energy Conversion Equipment

EES Essential Electrical System

kVA Kilovolt Amps

kW Kilowatts

LED Light-emitting Diode

LIM Line Isolation Monitor

N2O Nitrous Oxide

O2 Oxygen

OR Operating Room

SEPSS Stored Emergency Power Supply System

WAGD Waste Anesthetic Gas Disposal



Standards, Characteristics, and Requirements for Ambulatory Surgical Centers in Conformance with CMS CIC

1. Facility Background InformationYES NO NA

1.1 The ASC’s construction started, or all pertinent permits were approved, before July 5, 2016. o o

If YES, the ASC is considered to be EXISTING. If NO, the ASC is considered to be NEW.

1.2 This entry is intentionally blank. Reserved for future use.

1.3 Have there been additions to, or changes in, the EXISTING ASC on or after July 5, 2016? o o o

If YES, briefly describe:

1.4 How many stories, not including basements, are there in the overall building? ______Stories

A basement is fundamentally defined as any level below the level of the building where a majority of exits and exit capacity occur directly at grade level (without exterior stairs to grade) — i.e., basements are levels below the primary “exit/egress level.” If no floors exit directly at grade level, basements occur below the level with the shortest exterior stairs to grade.

1.5 Is the ASC located on the exit/egress level? o o

1.6 Are there any basements in the overall building? o o

If YES, does the ASC control all access to the basement(s)? o o

1.7 Is there fire proofing applied to (covering) all structural members and surfaces (columns, structural walls, floor decks, roof decks, joists, beams, etc.)?

o o

1.8 Is the entire building provided with a fire sprinkler system? o o

1.9 If only part of the building is provided with a fire sprinkler system, what areas are sprinklered? o

1.10 Are any ASC areas used by other entities at any time? o o

If YES, is the ASC open during the time the space is shared? o o

1.11 What is the total area of the ASC, not including building common areas, outside of the ASC? ____________SF



2. Construction/GeneralC NC NA

2.1 All features of fire protection or life safety design that are not required and are visually obvious to the public are either removed, or maintained in continuous compliance as if required.

o o o

NFPA 101: 4.6.12.3

BUILDING SHELL ACCEPTABILITY

2.2 There are no non-healthcare-related occupancies with high hazard contents in the building. o o

NFPA 101: 20/21.1.3.7

2.3 Building construction type (combustibility and fire proofing of structural members) and/or fire protection complies with NFPA 101 Section 20.1.6/21.1.6 requirements for NEW/EXISTING ASC development, as evidenced by at least one of the following:

o o

£ The overall building shell is one story, not counting basements (see section 1.4 definition of basements).

£ Every space of every story of the overall building shell is protected by a supervised automatic fire sprinkler system — see items 2.12–2.17.

£ Every structural member and/or system used in the overall building shell is enclosed with fire-resistive material with at least the rating required by NFPA 101 table 20.1.6.1 (NEW) or 21.1.6.1 (EXISTING), which addresses combustibility and fire proofing of structural members.

NFPA 101: 20/21.1.6

2.4 If the building provides one basement level, at least one of the following conditions is met: o o o

£ The floor system between the discharge level and the basement is of 1-hour minimum fire-rated construction (minimum 1-hour rated fire proofing on all structural members and surfaces).

£ The basement is under control of the ASC, and hazardous areas (if any) are protected as described in NFPA 101 Section 8.7 — see item 6.2.

NFPA 101: 20/21.1.6

2.5 If the building provides more than one basement level, the floor system of the discharge level is of 1-hour minimum fire-rated and non-combustible construction (NFPA 220 Type II (111) or better).

o o o

NFPA 101: 20.1.6, 21.1.6

2.6 If the building (all stories) housing the ASC is physically attached to or abutting another building of lesser construction type or fire protection, a 2-hour or greater fire barrier in accordance with NFPA 221, Standard for High Challenge Fire Walls, Fire Walls and Fire Barrier Walls, exists between the building portion housing the ASC and the adjacent building portion with lesser construction type and/or fire protection.

o o o

NFPA 101: 20.1.1.4, 21.1.1.4



C NC NA

2.7 Walls separating parking structures from an ASC or shell building housing an ASC have a 2-hour minimum fire resistance rating. Open-air parking structures, and parking structures protected throughout with an approved automatic sprinkler system, are permitted to have nonrated opening assemblies at the main entrance and associated sidelight areas (no larger than 25% of the exposed wall) contingent on: the shell building is fully protected by a supervised automatic fire sprinkler system; a method is provided to avoid spilled fuel from gathering near the openings and/or entering the building; physical obstacles assure vehicles are at all times kept at least 10 feet away from the openings; and all doors in opening assemblies are self-closing and create a barrier against the transfer of smoke.

o o o

NFPA 101: 20.1.1.1.4, 21.1.1.1.4, 38.1.3.2, 39.1.3.2

2.8 Every floor in a multi-story building (including basements) is constructed as a smoke barrier extending from exterior wall face to exterior wall face.

o o o

NFPA 101: 8.5

REPAIR AND IMPROVEMENT PARAMETERS

2.9 Buildings or portions thereof that remain occupied during construction, repair, alterations, or additions remain in compliance with all of the following:

o o o

£ Required means of egress and fire protection are continuously maintained for the portions of space occupied, or alternate life safety measures acceptable to authorities are in place and adhered to.

£ Adequate escape routes and/or methods are maintained for construction workers at all times in accordance with principles of life safety design and construction as can reasonably be applied under construction conditions.

£ Flammable or explosive materials or equipment are only present when the building is unoccupied, or when conditions of use and protection mitigate potential adverse effects on egress and life safety design.

NFPA 101: 4.6.10, 20/21.7.9

2.10 The means of egress in any building undergoing construction, repair, or improvement is inspected daily to assure it remains continuously free of any obstructions or impediments to full spontaneous use in the case of fire or other emergency.

o o o

NFPA 101: 7.1.10.1, 20/21.7.9

2.11 The scope and complexity of work on, or modifications to, EXISTING buildings complies with NFPA 101, “Chapter 43 Building Rehabilitation” relative to the following considerations:

o o o

£ Portions and aspects of work required to adhere to NFPA standards and requirements for NEW vs. EXISTING buildings and/or construction.

£ Permissible deviations from full literal compliance NFPA standards and requirements.

£ Ramifications to changes in occupancy to all or part of a building.

NFPA 101: 43

SUPERVISED AUTOMATIC FIRE SPRINKLER SYSTEMS — IF APPLICABLE

2.12 The installation of NEW fire sprinkler systems includes the performance of all NFPA 13 section: 24.2-required acceptance tests including documentation (as applicable) of “Contractor’s Material and Test Certificate for Aboveground Piping” and/or “Contractor’s Material and Test Certificate for Underground Piping.”

o o o

NFPA 13:24.1



C NC NA

2.13 Wet Pipe systems include a pressure gauge installed above and below each alarm check valve or system riser check valve when provided.

o o o

NFPA 13: 7.1

2.14 Dry Pipe systems include pressure gauges installed on the water and air sides of the dry pipe valve, at the air pump and air receiver if provided, at each separate pipe from the air supply to the system, and at accelerators.

o o o

NFPA 13: 7.2

2.15 Supervised automatic sprinkler systems are installed in compliance with NFPA 13, including but not limited to:

o o

£ A stock of spare sprinkler heads is provided per NFPA 13: 6.2.9.

£ Hydraulically designed systems include a Hydraulic Design Information Sign in accordance with NFPA 13:24.5.

£ NEW systems include a General Information Sign in accordance with NFPA 13: 24.6.

£ Valves for Control, Drain, and Test connections are provided with permanently marked and securely attached weatherproof identification signs per NFPA 13: 6.7.4.

£ A duplex Fire Department Connection is provided, except for systems with a 3-inch or smaller riser which may have a single connection.

£ The sprinkler system includes waterflow-sensing alarm actuating device(s).

£ At least one sprinkler head is provided in every room or space throughout the building. Multiple sprinkler heads are provided in rooms and spaces as necessary to fully protect all areas of every floor level per NFPA 13. Sprinkler heads may be omitted in dedicated electrical equipment rooms that are fully enclosed in 2-hour fire-rated construction, and used exclusively for dry-type electrical equipment installation, with no combustible materials present.

£ The distance between any sprinkler head deflector and the top of storage within its spray pattern is at least 18 in.

£ Fire sprinkler heads are installed at least 4 in. from wall surfaces.

£ An alarm signal is triggered by any flow of water from a sprinkler system equal to or greater than that from a single sprinkler head.

NFPA 101:9.7; NFPA 13:6,7, 8, 24, 26

2.16 Automatic sprinkler and standpipe systems are maintained (inspection, testing, and maintenance) according to requirements of NFPA 25 Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems, including but not limited to:

£ Inspections required by NFPA 25 on a daily, weekly, monthly, quarterly, and 5-year frequency as applicable to the system design and components.

£ Tests required by NFPA 25 on a quarterly, semiannual, annual, 3-year, 5-year, 10-year, 20- year, 50-year, and 75-year frequency as applicable to the system design andcomponents.

£ Maintenance required by NFPA 25 on an annual frequency as applicable to the system design and components.

NFPA 101: 9.7; NFPA 25: 5



Physical Environment Checklist C NC NA

2.17 A designated Impairment Coordinator assures that when the fire sprinkler system is impaired (partially or fully disabled) or is anticipated to be impaired for more than 10 hours in any given 24-hour period, one or more of the following is accomplished:

£ The ASC is evacuated (AAAHC Ch. 8.I, Standard K.1).

£ An approved fire watch is established (AAAHC Ch. 8.I, Standard K.2). A temporary sprinkler system water supply is established, if applicable.

£ NFPA 25:5.5.2-approved measures are accomplished to mitigate the risk of fire, or adverse consequences related to the specific system impairment.

NFPA 101: 9.7; NFPA 25: 15




3. Means of Egress C NC NA

3.1 At least two exits are provided for each floor and fire section of the building. The distance between the exits complies with the following as applicable:

o o

£ In NEW buildings protected throughout by an approved sprinkler system (see items 2.12 – 2.17), a dimension at least equal to one-third of the maximum overall straight-line dimension of the areas served separates the two exits furthest apart.

£ In NEW buildings not protected throughout by an approved sprinkler system, a dimension at least equal to one-half the maximum overall straight-line dimension of the areas served separates the two exits furthest apart.

£ Where fire-rated exit enclosures serve as the required exits from a floor, and such exits are connected by a 1-hour (minimum) rated corridor, the effective distance between the exit enclosures may be measured along the path of travel through the rated corridor.

£ EXISTING building exits are exempt from the maximum diagonal basis for separation as long as the exits are remote from each other and arranged to minimize the possibility both could be blocked by any one emergency situation.

NFPA 101: 7.5.1.3, 20/21.2.4.2

3.2 ASCs, regardless of size, are provided with at least two exits. A room or suite of rooms with total area greater than 2,500 square feet are served by at least two exit access doors. In buildings protected throughout by an approved sprinkler system (see item 2.12), a dimension at least equal to one-third the overall straight-line dimension of the areas served separates the two exit access doors furthest apart. In buildings not protected throughout by an approved sprinkler system, a dimension at least equal to one-half the overall straight-line dimension of the areas served separates the two exit access doors furthest apart.

o o o

NFPA 101: 7.5, 20/21.2.4.3

TYPES OF EXITS

3.3 Allowable types of required exits provided are limited to: o o

£ Swing-type doors in exit passageways and at exits that comply with the following:

§ Doors that serve an occupant load of 50 or more, all doors into an exit enclosure, and doors at high hazard content rooms, swing in the direction of egress travel.

§ At no point during its swing does a door (other than into EXISTING exit stair enclosures) overlap more than one-half the required width of a passage that may be used to reach an exit.

§ When fully open, no door may overlap more than 7 in. of the required width of a passage that may be used to reach an exit – see item 3.19.

§ Doors in NEW buildings’ and ASCs’ means of egress provide at least a 32-in. clear opening when opened 90 degrees. With a pair of manually operated doors, at least 1 leaf must provide the 32-in. clearance alone. Rooms ≤ 70 SF that are not required to be accessible may be served by an exit access door as narrow as 24-in. nominal width.

§ Doors in EXISTING buildings’ means of egress provide at least a 28-in. clear opening when fully open.

§ Doors in EXISTING ASCs’ means of egress provide at least a 32-in. clear opening when opened 90 degrees, or are EXISTING 34-in. wide doors.

§ Panic or fire exit hardware may project up to 4 in. into the required door opening in the area between 34 in. and 48 in. above the floor.




§ The maximum change in floor level across a door opening is ½ in. extending at least the door width in each direction.

§ The maximum raised threshold height at a door opening is ½ in. Any threshold height or floor level change at a door opening beyond ¼ in. in height is accomplished with a slope no steeper than 1 vertical for 2 horizontal.

§ EXISTING building exterior doors may step down a maximum of 8 in. on the exterior side.

§ The exterior door(s) at the building’s principal entrance are permitted to have key operated locks in the direction of egress only as long as they are provided with a clearly visible and durable sign with 1-in.-high letters on a contrasting background that states “THIS DOOR TO REMAIN UNLOCKED WHEN THE BUILDING IS OCCUPIED.” The locking device’s design must make it obvious when the door is locked, and a key must be available to any occupant when the door is locked.

§ Delayed egress locking systems are permitted on egress doors when in full compliance with NFPA 101:7.2.1.6.1.

§ Access controlled egress doors acting in the direction of exit travel must comply with NFPA 101:7.2.1.6.2.

§ Power-operated doors capable of swinging in the direction of exit travel (break-away swing required for sliding-type) are provided with a sign visible in the direction of exit travel with 1-in.-high (minimum) letters stating “IN EMERGENCY, PUSH TO OPEN.”

§ Horizontal or vertical security grilles or doors in the exit egress must comply with NFPA 101: 7.2.1.4.1(3).

§ Revolving doors in the exit egress must comply with NFPA 101: 7.2.1.10.

£ Stairs used in the means of egress that comply with the following:

§ NEW stairs with a total occupant load < 50 are at least 36 in. wide (except for projections at or below handrail height of 4 ½ in. or less on each side). NEW stairs with a total occupant load of 50 – 1,999 are least 44 in. wide (except for projections at or below handrail height of 4 ½ in. or less on each side). NEW stairs with a total occupant load of ≥ 2,000 are least 56 in. wide (except for projections at or below handrail height of 4 ½ in. or less on each side). NEW stairs have a maximum step height of 7 in. and a minimum step height of 4 in. NEW stair treads have a minimum depth of 11 in. Handrails are required at both sides of NEW stairs. Intermediate handrails are required in NEW stairs wider than 60 in. such that a handrail is always within 30 in. of all portions of the stair width.

§ EXISTING stairs are at least 36 in. wide (except for projections at or below handrail height of 4 ½ in. or less on each side). EXISTING stairs have a maximum step height of 8 in. and a minimum step height of 4 in. EXISTING stair treads have a minimum depth of 9 in. Handrails are required on at least one side of EXISTING stairs no wider than 44 in. Additional handrails are required in EXISTING stairs such that a handrail is always within 44 in. of all portions of the stair width.

§ A single step at a curb separating a vehicular drive from adjacent walkways does not require handrails.

§ Required handrails continue for the full length of each flight of stairs. At turns of NEW stairs, inside handrails are continuous between flights at landings.

§ All stairs provide a maximum height between landings of 12 ft.




C NC NA

§ All adjacent stair steps and treads are within 3/16 in. of a uniform height. All stair steps and treads in a single flight are within 3/8 in. of a uniform height.

§ Spiral stairs are permitted if in compliance with NFPA 101: 7.2.2.2.3.

§ EXISTING winders (stairs with trapezoidal steps instead of landings at bends in a flight) are permitted if in conformance with NFPA 101: 7.2.2.2.4.

§ Landings are provided at door openings. Stair and landing widths do not reduce in the direction of exit travel.

§ Landings for NEW stairs are at least as deep as the stair is wide (with a maximum required 48 in. in a straight run).

§ Landings at the top of an EXISTING stair are acceptable with a minimum depth equal to the width of the door leaf, as long as the total occupant load of the door is < 50.

§ Stair treads and landings are solid (no perforations) and without irregularities that could lead to tripping.

§ Interior exit pathway stairs are enclosed according to the following, as applicable:

o In EXISTING buildings, up to one-half of the required number and capacity of exits may be provided with “partially enclosed” two-story stairs connecting the story of exit discharge with the story immediately above, as long as each exit stair is open only to the upper floor area (and is enclosed with 1-hour rated walls and protected openings at the level of exit discharge).

o All other interior stairs connecting three or fewer stories in NEW buildings, and all interior stairs in EXISTING buildings where the highest occupied floor level is no more than 75 feet above lowest fire department access, are enclosed in a minimum of 1-hour fire-resistive construction.

o In NEW buildings, interior stairs connecting more than three stories are enclosed in a minimum of 2-hour fire resistive construction.

o All stairs in buildings in which the highest occupied floor level is more than 75 feet above lowest fire department access are enclosed in a minimum of 2-hour fire-resistive construction — see section 14 “High-Rise Buildings.”

§ Doors serving exit stairway enclosures that are swing-type and equipped with release hardware that is obvious to use and requires only one motion/action to operate. The release hardware is mounted between 34 in. and 48 in. above the floor and is operable in the direction of exit travel.

§ Enclosed usable spaces within an exit stair are separated from it by fire-resistive construction equal or higher than that of the stair enclosure itself. No doors are provided into such enclosed spaces from inside the stair enclosure.

§ Interior stairs connecting five stories or more provide signage inside the stair at each floor level landing that identifies the floor level, the lowest and highest floor connected, and the direction or travel to the exit level from the stair. Such sign is mounted approximately 5 feet above the floor, and is easily visible when any adjacent door is open or closed.

§ All stairs extending more than one story below the level of exit discharge provide a sign at every floor level landing directing travel to the level of exit discharge.

§ Exterior stair design includes visual barriers to ensure usability by individuals with a fear of heights. With exterior stairs four stories or higher, such visual barrier must be at least 48 in. above adjacent stair and landing surface levels. Exterior ramps and landings are built to avoid the accumulation of water.




§ Exterior stairs and landings are built to avoid the accumulation of water.

§ The wall separating the building interior from exterior exit stairs is protected (fire-resistive rating) as required of interior stair enclosures, for a distance of 10 feet both horizontally (from both exterior wall faces) and vertically (measured from the top landing). Such protection is not required where two or more exterior exit stairs serve an exterior exit balcony. If a remote second exit is available, exterior stairs connecting no more than two stories in a NEW building, or three stories in an EXISTING building, do not need to be protected from the interior space.

§ Stairs do not continue more than one-half story past the level of exit discharge, except where a physical obstacle (such as a gate) interrupts movement at the level of exit discharge.

£ Smoke proof enclosures in compliance with NFPA 101: 7.2.3.

£ Horizontal exits through a fire barrier with at least a 2-hour rating may account for up to one- half the required exit capacity for the entire building, contingent on compliance with NFPA 101: 7.2.4 including, but not limited to, all the following conditions:

§ Egress door assemblies in the fire barrier swing in direction of egress and may not be locked against egress from an occupied side.

§ Horizontal exit fire barriers are not penetrated by ducts, except EXISTING ducts equipped with approved and listed fire dampers or in buildings protected throughout by an approved supervised automatic sprinkler system.

§ Doors used in conjunction with a horizontal exit are unlocked from the egress side at all times that either side of the fire separation is occupied. The floor area on each side of the fire separation provides at least 3 SF of clear floor area for each of the total occupants of both sides. If the horizontal exit serves both sides of the fire separation, pairs of adjacent doors are provided with opposing swings into each side of the fire barrier.

§ Doors in horizontal exits are self-closing, and are installed to minimize air leakage.

£ Ramps in exit passageways and at exits comply with the following:

§ NEW ramps are at least 44-in. wide with a maximum slope of 1 in 12, a maximum cross slope of 1 in 48, and a landing for every 30 in. of vertical rise.

§ EXISTING ramps are at least 30-in. wide with a maximum slope of 1 in 8, and a landing for every 12 ft. of vertical rise.

§ Ramps in the exit egress are of permanent fixed construction, with solid walking surfaces (no perforations).

§ Landings are sloped no more than 1 in 48 in any direction, are at least the same width as adjacent runs, and are at least 60-in. long. Any change in direction of travel on a NEW ramp occurs at a landing. Ramps and their landings do not decrease in width in the direction of exit travel.

§ Ramps with a rise greater than 6 in. are provided with handrails at both sides. Ramps at curbs (“curb-cuts”) separating a vehicular drive from adjacent walkways do not require handrails. Required handrails continue for the full length of the sloped portion of each ramp. At turns of NEW ramps, inside handrails are continuous between slopes at landings.

§ Ramps do not continue more than one-half story past the level of exit discharge, except where a physical obstacle (such as a gate) interrupts movement at the level of exit discharge.




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§ Exterior ramp design includes visual barriers to ensure usability by individuals with a fear of heights. With exterior ramps greater than 36 ft. above the ground, such visual barriers must be at least 48 in. above adjacent ramp and landing surface levels.

§ Exterior ramps and landings are built to avoid the accumulation of water.

£ Exit passageways (horizontal extensions of an exit or exit enclosure) are separated from all other areas of the building by fire-resistive construction with a 1-hour rating or higher, to correspond with the rating of the area or exit element served (at least equal to rating of exit enclosure it provides access to, such as an enclosed stair tower).

£ EXISTING fire escape stairs may account for up to 50% of required egress capacity in EXISTING buildings only, contingent on compliance with all applicable requirements of NFPA 101: 7.2.8.

£ Required exit enclosures conform with all the following conditions:

§ In NEW construction, exit stair enclosures connecting three or fewer stories are enclosed in a minimum of 1-hour fire-resistive construction. In NEW construction, exit stair enclosures connecting more than three stories are enclosed in a minimum of 2-hour fire resistive construction.

§ In EXISTING non-high-rise buildings, exit stair enclosures are enclosed in 1-hour rated construction.

§ NEW exit separation walls are supported by construction with a 1-hour minimum rating.

§ Openings in exit enclosures are limited to those providing access to the enclosure from occupied spaces or to the exit egress, and are protected by fire-rated assemblies including self-closing doors. EXISTING exit enclosures allow the following exceptions:

o EXISTING fire-rated assemblies in buildings of Type I or II construction may provide access to interstitial spaces used solely for pipe, duct, and conduit distribution. Such interstitial space is not used for storage and is outside the exit enclosure’s fire separation surfaces.

o EXISTING fire-rated openings into mechanical equipment rooms used solely for non-fuel-fired equipment, with no storage of combustible materials, inside a building protected throughout by an approved supervised sprinkler system.

§ Penetrations into or through exit enclosures are limited to properly rated door assemblies, electrical conduit serving the enclosure, required exit access doors, ductwork and equipment related to stair pressurization, water or steam piping related to heating or cooling the exit enclosure, fire sprinkler piping, and/or standpipes. Conduit for fire alarm circuitry, and EXISTING penetrations, are permitted if protected as penetrations in a fire barrier — see item 12.4.

§ EXISTING penetrations into or through exit enclosures are in compliance with items 12.4 and 12.7.

§ Exit enclosures provide a clear and continuous protected path to an exit discharge and are not used in any way that could potentially interfere with its use as an exit or area of refuge

§ Doors serving exit enclosures swing in the direction of egress travel.

NFPA 101: 7.1.3.2, 7.2.1, 7.2.2, 7.2.3, 7.2.4, 7.2.5, 7.2.6, 7.2.7, 7.2.8, 7.2.9, 7.2.11, 20/21.2,38/39.2.2




EGRESS CONFIGURATION & DETAIL

3.4 NEW egress corridors do not pass through intervening rooms other than lobbies, other corridors, or areas permitted to be open to corridors. Corridors that are not required to be fire-rated may discharge into open floor plan areas.

o o o

NFPA 101:7.5.1.2, 7.5.1.2.2

3.5 EXISTING corridors that must pass through a room for egress are permitted to continue in use as long as approved exit signs are provided and intervening doors comply with egress clearances and function.

o o o

NFPA 101:7.5.1.2.1

3.6 Walking surfaces of corridors and passageways have no abrupt vertical irregularities exceeding ¼ in. in height. Changes in elevation exceeding ¼ in., but not exceeding ½ in., are beveled no steeper than a ratio of 1 (vertical) to 2 (horizontal). Changes in elevation exceeding ½ in. are made with stairs or ramps. Where such vertical change is less than 21 in. the existence of a ramp must be visually obvious and/or stair treads must be at least 13-in. deep.

o o

NFPA 101: 7.1.7

3.7 All portions of the exit pathway are at all times kept free of physical and visual obstructions (including furnishings or decorations), impediments, or conditions that could interfere with immediate use under emergency conditions. Mirrors are not located on exit doors, or adjacent to an exit in a manner that could confuse the direction of exit travel. Exit doors and pathways are clearly recognizable and are not obscured by hangings, draperies, or other visual or physical impediments.

o o

NFPA 101: 7.1.10

3.8 Windows that can be mistaken as exits or exit pathway doors are made obviously inaccessible by physical barriers or railings.

o o o

NFPA 101: 7.2.1.1

3.9 Handrails provided on either or both sides of exit elements or access ways conform with all the following:

o o o

£ The design, installation, and materials of handrails and other surfaces bounding exit pathways do not include projections, textures, or openings that will catch on loose clothing.

£ NEW required handrails on stairs and ramps are not less than 34 in. and not more than 38 in. above the walking surface, measured vertically to the top of the rail from the leading edge of the tread or ramp surface. EXISTING required handrails are not less than 30 in. and not more than 38 in. above the corresponding reference point.

£ Handrails have a circular cross section with an outside diameter of not less than 1¼ in. and not more than 2 in. NEW handrails provide a clearance of at least 2¼ in. between the handrail and the wall to which it is fastened.

£ NEW handrails are continuously graspable for their entire length.

£ The ends of NEW handrails return to the wall or floor, or terminate at newel posts. NEW handrails that do not continue unbroken between flights extend horizontally at least 12 in. beyond the top riser and continue to slope for a least the depth of one tread past the bottom riser.

NFPA 101: 7.2.2.4.1, 7.2.2.4.4




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3.10 No room or area occurs in the path of egress from another room or space that is not accessory to it. No portion of the exit egress requires passage through a hazardous area.

o o

NFPA 101: 7.5.1

3.11 No portion of a required exit access involves passage through a kitchen, storeroom, restroom, workroom, or any room subject to locking against the direction of egress.

o o

NFPA 101: 7.5.2

3.12 At least two exits are accessible from each smoke compartment. Where egress passes through adjacent smoke compartments, it is possible to reach the exit without passing back through the compartment where the fire started.

o o o

NFPA 101: 20/21.2.4.4

3.13 In NEW buildings or suites, corridors providing access to exit(s) in only one direction (dead-end passages) are limited to 20 feet in length, except in buildings protected throughout by an approved automatic sprinkler system, where dead-end passages may be up to 50-feet long. In all EXISTING ASCs or shell common areas, dead-end passages may be up to 50-feet long.

o o o

NFPA 101: 38/39.2.5.2

3.14 The distance traveled between any point in the building or suite and a location where one can proceed in at least two different directions to access at least two different exits is no greater than 75 feet in length, except in buildings fully protected by an approved automatic sprinkler system and/or in ASCs ≤ 3,000 SF, where the distance may be up to 100 feet.

o o

NFPA 101: 38/39.2.5.3

3.15 The maximum distance between any point in an occupiable room and the nearest exit door (into a rated enclosure, or direct to the exterior) is no greater than 150 feet, except in buildings fully protected by an approved automatic sprinkler system, where the distance is limited to 200 feet.

o o

NFPA 101: 20/21.2.6.2




3.16 Buildings not provided with an approved automatic sprinkler system provide at least one accessible area of refuge or one accessible exit providing an accessible route to an exit discharge for the floor level of the ASC. Areas of refuge comply with all of the following:

o o o

£ Each area of refuge is sized to accommodate one wheelchair space of 30 in. by 48 in. (without overlapping required egress widths) for every 200 occupants, or portion thereof. Access to any wheelchair space does not cross more than one adjacent wheelchair space, and connects to an exit enclosure or passage.

£ Areas of refuge provide a two-way communication system with a central control point, including instructions for use.

£ Areas of refuge are separated from other non-egress areas by construction with a minimum 1-hour fire-resistive rating, including self-closing doors. Ducts penetrating this fire separation barrier are equipped with smoke-actuated dampers.

£ Areas of refuge provide a direct egress path to grade level discharge by way of an approved stair or an elevator complying with NFPA 101: 7.2.12.2.4.

£ NEW stairs serving as exits from areas of refuge provide a minimum 48-in. clear stair and landing width between handrails and below handrail height, unless the stair is separated from the building by a horizontal exit.

£ EXISTING stairs serving as exits from areas of refuge provide a minimum 37-in. clear stair and landing width between handrails and below handrail height.

£ Each area of refuge shall be identified by a sign stating, “AREA OF REFUGE.” Signs conform to the requirements of CABO/ANSI A117.1 and are illuminated as required for exit signs.

NFPA 101: 7.2.12

3.17 No more than half the required number of exits and exit capacity (passage width and/or number and size of doors) of a NEW multistory building includes passage through interior spaces on the ground floor (between the exit level of the exit stair and the building exit). No more than half the required number of exits of an EXISTING multistory building includes passage through interior spaces on the ground floor (between the exit level of the exit stair and the building exit). Such passages are obvious and follow a clear unobstructed path directly through one or more exit discharge doors to the exterior. The entire egress area on the floor of exit discharge is separated from levels below by construction with the fire-resistive rating required of an enclosed stair, except in atriums compliant with NFPA 101: 8.6.7 (see item 5.1). The discharge level interior space complies with one of the following:

o o

£ The entire floor level is fully sprinklered.

£ The portion of it used for exit travel is sprinklered, and separated from unsprinklered areas by construction with the fire-resistive rating required of the exit enclosure.

£ The portion of it used for exit travel occurs entirely within a dedicated exit vestibule or foyer (no other interior use) inset from the building exterior face no more than 10 feet with a length no greater than 30 feet long, and the foyer is separated from the remainder of the building by construction at least equal in fire resistance to wired glass in a metal frame (or 45 minute fire resistive).

NFPA 101: 7.7, 20/21.2.7, 38/39.2.7

3.18 Exits only discharge to a rooftop where sections of the roof/ceiling assembly are constructed with the fire-resistive rating required of the exit enclosure, and a reliable safe means of egress from the rooftop is provided.

o o

NFPA 101: 7.7, 20/21.2.7, 38/39.2.7




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3.19 All corridors and passageways leading from occupied rooms to and through building exits are at least 44 in. in clear width, except portions of the exit access where greater widths are necessary due to occupant loads per NFPA 101: 7.3.1. Projections into the required width are no greater than 4.5 in. on each side and occur 38 in. or less above the floor, except that stair and landing handrails forming part of a guardrail are permitted to have 4.5-in. projections 42 in. or less from the floor. ABHR dispensers in passages 6 ft. clear or wider may project up to 6 in. from the wall (above handrail height).

o o

NFPA 101: 7.3.2, 7.3.4, 20/21.2.3.2, 20/21.2.3.3

EGRESS LIGHTING

3.20 All areas and pathways provided for circulation from doors serving occupied spaces through to building discharge and on to publicly accessible exterior areas (i.e., the means of egress), are continuously lighted while the facility is occupied. Exit pathway lighting is powered by a source considered to be continuously available and reliable, such as a public utility. No portable or battery-powered light fixtures are used for general occupancy exit pathway lighting. Exit pathway lighting is adequate to assure comfortable use and safe movement between occupied spaces. In floor level passages and EXISTING stairs, the required lighting level is at least 1-foot candle; NEW stairs require a minimum 10-foot candles. The lighting design includes adequate fixture overlap or redundancy to assure that failure of any single lighting fixture or bulb does not reduce the light level in any area below that necessary for ordinary safe passage through the building (0.2-foot candles minimum).

o o

NFPA 101: 7.8, 20/21.2.8

3.21 Automatic, motion sensor-type light switches are permitted for controlling the minimum required egress lighting, as long as all the following apply:

o o o

£ The switch controllers are listed and manufactured to assure switch failure results in the egress lights controlled being switched on.

£ The lights controlled remain on for at least 15 minutes following each activation.

£ The switch controller is activated by an occupant’s motion at any point on the egress area served and/or by activation of the fire alarm system.

NFPA 101: 7.8.1.2.2

3.22 Emergency lighting is provided in the means of egress for a period of at least 90 minutes following a loss of normal power, at a level adequate to ensure safe passage without tripping on, or impacting, obstacles or surfaces (at least 1-foot candle average), and not less than 0.1-foot candle at any specific point, measured along the path of egress at floor level). Illumination levels are permitted to decline by 40% (to 60% of the initial required minimum) at the end of the 90-minute minimum duration. Emergency lighting activates automatically within 10 seconds of a disruption in normal lighting due to loss of normal power to the building, the tripping of a circuit breaker or fuse, or the switching off of normal light fixtures. The emergency lighting system is either continuously functioning, or capable of repeated automatic activation without manual intervention.

o o

NFPA 101: 7.9, 20/1.2.9.1

3.23 When a NEW emergency power system for egress lighting is provided by a generator set, it must comply with NFPA 110 requirements for a Type 10, Class 1.5, Level 1 system. EXISTING emergency lighting systems powered by a generator set must comply with NFPA 110.

o o o

NFPA 101: 7.9, 20/1.2.9.1

3.24 When an EXISTING emergency power system for egress lighting is provided by a generator set, it must comply with NFPA 110 requirements.

o o o

NFPA 101: 7.9, 20/1.2.9.1




3.25 When a battery system provides power for emergency egress lighting it must comply with NFPA 111.

o o o

NFPA 101: 7.9, 20/1.2.9.1

3.26 When self-contained rechargeable batteries provide emergency power to NEW individual emergency light fixtures the emergency power assemblies must be Listed ANSI/UL 924.

o o o

NFPA 101: 7.9, 20/1.2.9.1

3.27 When self-contained rechargeable batteries provide alternate power to EXISTING individual emergency light fixtures, they are a rechargeable type with an extended useful life even when infrequently used and recharged, in compliance with NFPA 70. The battery equipment and/or system is designed to ensure that recharging of batteries is automatic upon the return of normal power, even if the rechargeable batteries have been exhausted.

o o o

NFPA 101: 7.9, 20/1.2.9.1

3.28 Fixtures providing emergency lighting of the means of egress are inspected for physical/functional integrity and tested for a period of at least 30 seconds every month (at 3 to 5-week intervals). Battery-powered (alternate source) systems and/or fixtures are tested annually for a minimum duration of 90 minutes. Equipment failing any required inspection or test is repaired or replaced immediately. Written records of inspections, tests and maintenance are kept on-site.

o o o

NFPA 101: 7.9, 20/21.2.9.1

3.29 Required emergency lighting systems are inspected and tested in any of the following ways: o o

£ Manual inspection and testing of each emergency light fixture.

£ Battery-powered (alternate source) lighting equipment designed and installed to be self-testing/ self-diagnosing on the monthly and annual basis requires only visual inspection of the diagnostic status of each fixture on the monthly and annual schedules.

£ Battery-powered (alternate source) lighting equipment designed and installed to be computer-based self-testing/self-diagnosing on the monthly and annual basis be capable of providing a report of the history of tests and failures upon demand.

NFPA 101: 7.9, 20/21.2.9.1




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EGRESS IDENTIFICATION

3.30 Exits and the paths of travel to them are identified in conformance with all of the following conditions, as applicable:

o o

£ Except for clear and obvious main entrances, all exit doors are identified with signs readily visible from any direction of travel toward them.

£ If the direction of travel toward the nearest exit in an exit enclosure is not obvious, approved exit or directional exit signs are provided.

£ In NEW ASCs and NEW buildings (or EXISTING buildings not previously housing an ASC), tactile signs are provided at each door requiring an exit sign, stating “EXIT.” These tactile signs provide both visual and tactile (raised at least 1/32 in. above background) characters (sans serif, upper case, between 1/2-in. and 2-in. high) that are duplicated in braille and are mounted 60 in. above the floor on the latch side of the door.

£ If an exit is not immediately visible or the path to reach the nearest exit is not obvious, there are directional signs and exit signs above egress openings indicating exit access. No point in the exit access is more than 100 feet from the nearest exit sign, or in excess of the listed visible range of the nearest exit sign.

£ Exit and exit access signs are located and large enough to be clearly visible (by contrast with adjacent finishes and materials) under normal and emergency lighting conditions. No decorations, furnishings, or equipment impair their visibility. No brightly illuminated sign for other than exiting purposes, display, or object interferes or competes with the visibility of required exit signs.

£ The bottoms of NEW exit signs are located within 6 ft. 8 in. of the top of the openings they identify. The maximum horizontal offset of signs from egress openings is equal to the required width of the corresponding opening.

NFPA 101: 7.10.1-3, 20/21: 2.10




3.31 Exit, directional exit, and special purpose signs (“no exit” and egress elevator) are designed and illuminated as follows:

o o

£ All signs are adequately and reliably lighted either internally or externally, and legible in both normal and emergency lighting conditions.

£ Lighting of signs except approved self-luminous and listed photoluminescent types, conforms to the requirements for emergency egress lighting. (See items 3.22 through 3.29, as applicable.) Sign illumination is permitted to flash on and off upon activation of the fire alarm.

£ Externally illuminated signs (except tactile signs required on the latch side of egress doors) have plainly legible letters not less than 6-in. high (4 in. acceptable in EXISTING facilities) with principle letter strokes of at least 3/4-in. width. The letters “E,” “X,” and “T” are at least 2-in. wide. There is at least a 3/8-in. space between letters. Signs with letters larger than described above have the same proportions of width, height, stroke, and spacing.

£ Larger externally illuminated signs than described above use letter widths, strokes, and spacing proportional to their greater height.

£ Externally illuminated signs are lighted by reliable sources providing at least 5-foot candles at the surface, with a minimum contrast ratio of 0.5.

£ Directional indicators on NEW exit signs are on the corresponding end of the lettering block, chevron in shape, and separated from the lettering by at least 3/8 in. Directional indicators are clearly distinguishable at a distance of at least 40 feet.

£ NEW internally illuminated signs (except tactile signs required on the latch side of egress doors) are listed as compliant with ANSI/UL 924.

£ Photoluminescent exit signs remain continuously lighted (by a fixture used to charge the sign) while the facility is occupied, at minimum brightness levels and fixture type specified by the exit sign manufacturer.

£ All doors, passages, and stairwells that are not part of the means of egress but could be mistaken as such are identified with a “NO EXIT” sign. The word “NO” is 2-in. high with a 3/8-in. stroke and is located above the word “EXIT” which has letters 1-in. high.

£ Elevators that are part of the approved means of egress have signs posted in each elevator lobby with a minimum letter height of 5/8 in. One sign indicates the elevator can be used for egress and identifies any restrictions on such use. A second sign indicates the current status of the elevator, such as “elevator in service,” or “wait for fire department or use stairs,” or “elevator out of service.”

£ Exit signs are visually inspected for proper illumination at least every 30 days.

NFPA 101: 7.10, 20.2.10, 21.2.10, CABO/ANSI A117.1

3.32 Lockups, if provided, comply with NFPA 101: 22.4.5.1.3. o o o

NFPA 101: 20/21 2.11.2, 22.4.5.1.3




4. Laboratory-Related Requirements

CHAPTER APPLIES? o YES o NO NOTE: This section applies to areas used for testing or analysis involving chemicals where

quantities of flammable, combustible, or hazardous materials are present, to the extent it represents a severe hazard.

NFPA 99:3/3/92, NFPA 101: 20/21: 3.2.2

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4.1 At minimum, duplex receptacles are installed 39.6 in. on center in laboratory instrument usage areas. Where instruments are located on counter tops, the receptacles are at least 3.15 in. above the counter.

o o

NFPA 99: 6.3.2.3

4.2 The laboratory has developed written policies for tests and testing intervals related to appliances used. At minimum, the physical integrity of each appliance’s power cord, plug and strain relief mechanism are visually inspected and appropriately tested on an annual basis.

o o

NFPA 99: 10.5.5

4.3 The fire protection and ventilation systems for the laboratory area comply with NFPA 45, Standard on Fire Protection for Laboratories Using Chemicals.

o o

NFPA 99: 15.4, 5.2.4

4.4 Laboratory gas appliances are installed per NFPA 54, National Fuel Gas Code. Shutoff valves for such appliance gases are clearly labeled for the gas controlled.

o o o

4.5 Heating, cooling, ventilation, and process systems in laboratory areas comply with NFPA 45, Standard on Fire Protection for Laboratories Using Chemicals.

o o



Physical Environment Checklist 5. Vertical Opening Protection

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5.1 Vertical openings through floors are protected in accordance with any of the following: o o o

£ Openings through floors are protected with fire barriers that are continuous from floor to floor, or from floor to roof deck, having a minimum 1-hour fire-resistive rating. Enclosures connecting more than three stories have a 2-hour fire-resistive rating. EXISTING vertical enclosures in EXISTING buildings may be 30-minute rated construction. EXISTING mail chutes are permitted in EXISTING buildings that are fully protected by a supervised automatic sprinkler system (see items 2.12-2.17), and/or in EXISTING buildings where the maximum chute cross sectional area is 14.4 SI.

£ Shafts that do not extend to the lowest floor level or roof deck are enclosed at the lowest and/or highest level with 1-hour minimum fire-rated construction, or 2-hour rated construction when the shaft connects four or more stories. EXISTING shafts in EXISTING buildings may be 30-minute rated construction throughout.

£ EXISTING unprotected vertical openings in EXISTING buildings comply with all the following:

§ The building is protected throughout by a supervised automatic fire sprinkler system.

§ No unprotected vertical openings occur along required means of egress.

§ All egress doors discharge exit directly at grade, to exterior exit stairs, through smoke- proof enclosures, or through horizontal exits.

£ Floors below the primary egress level used for storage, or other non-business occupancy areas, do not have unprotected vertical opening to business occupancy floors.

£ Unenclosed floor openings create communicating spaces between no more than three adjacent stories. At least one of the two bottom stories of the communicating space occur at grade-level (exit egress level). In buildings protected throughout by a supervised automatic sprinkler system (see items 2.12-2.17) communicating areas on each story served by the vertical opening are separated from all other areas with smoke barriers. In buildings not fully protected by a sprinkler system communicating areas on each story served by the vertical opening are separated from all other areas with 1-hour fire-resistive barriers. All areas in the communicating space are open and unobstructed so a fire in any location is immediately obvious to all occupants. The communicating space is protected by a sprinkler system, unless only low hazard contents are present in the communicating space. Required egress capacity at each level of the communicating space is based on the total occupancy of the overall communicating space. At least one exit on each story of the communicating space can be reached without traveling through another story of the communicating space. At least one exit is accessible to occupants outside communicating areas without entering the communicating space.

£ Atria occur only in buildings protected throughout by an automatic sprinkler system and that meet all requirements of NFPA 101: 8.6.7.

£ Partially unenclosed vertical openings connect no more than two adjacent stories, are not part of any required means of egress, and are open to only one of the stories.

£ Freely visible unenclosed vertical openings connect no more than two adjacent stories, are separated by 1-hour rated construction from other unprotected vertical openings extending to other stories, are not part of any required means of egress, and are separated from corridors; in NEW construction the separation from corridors is by smoke partition (at minimum) and no two such unenclosed vertical openings occur in the same smoke compartment on either floor.




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£ Escalators and moving walks in a required means of egress are protected as required for exit stairways (see item 3.3).

£ Exceptions meeting the conditions established in NFPA 101 Section 7.2.2.5, 8.6.9.7.

NFPA 101: 8.6, 20/21.3.1, 38/39.3.1

5.2 Where multiple doors are held open in a stair enclosure, all are controlled by automatic release devices that will close simultaneously upon automatic actuation (sensors and alarms).

o o o

NFPA 101: 20/21.2.2.4

5.3 NEW rubbish chutes and laundry chutes are separately enclosed by walls or partitions and protected as vertical openings. Doors for such chutes open only to a separate enclosed room designated exclusively for that purpose and separated from adjacent areas with fire-resistive construction appropriate to a hazardous storage area. EXISTING installations with appropriately protected service openings may open to a corridor or normally occupied space. Chutes may open into a storage room up to 400 SF in area if that room is protected with automatic sprinklers. Rubbish chutes, laundry chutes, and incinerators are installed and maintained in accordance with NFPA 82, Standard on Incinerators, Waste and Linen Handling Systems and Equipment.

o o o

NFPA 101: 9.5, 20/21.5.4



Physical Environment Checklist 6. Hazardous Area Protection

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6.1 Doors to rooms storing flammable, combustible, toxic, noxious, or corrosive materials (except routine office supplies) are self-closing or automatic closing (released by activation of the fire alarm system, and any/all other installed hazard detection devices or systems).

o o

NFPA 101: 3.3.21.4, 20/21.3.2.1

6.2 Hazardous areas (those with quantities of materials presenting a degree of hazard greater than normal for an ASC occupancy and/or boiler or furnace rooms) are protected by either of the following:

o o o

£ They are fully enclosed in a windowless 1-hour rated fire barrier extending from the floor to the floor/roof deck above, or from the floor to a 1-hour rated ceiling assembly. Door assemblies are rated at least 45 minutes.

£ The hazardous area is protected by a supervised automatic fire sprinkler system. In NEW construction a sprinkler-only protected hazardous area is also enclosed in a smoke partition.

NFPA 101: 6.2.2, 8.7, 20/21.3.2, 38/39.3.2

6.3 High hazard areas (those with materials likely to burn with extreme speed or from which explosions are likely) are protected by all of the following:

o o o

£ They are fully enclosed in a windowless 1-hour rated fire barrier extending from the floor to the floor/roof deck above, or from the floor to a 1-hour rated ceiling assembly. Door assemblies are rated at least 45 minutes.

£ The high hazard area is protected by a supervised automatic fire sprinkler system.

NFPA 101: 6.2.2, 8.7, 20/21.3.2, 38/39.3.2

6.4 High hazard areas presenting an explosion hazard are provided with explosion venting or suppression system in accordance with NFPA 68, Standard on Explosion Protection by Deflagration Venting, in addition to measures identified in item 6.3 above.

o o o

NFPA 101: 8.7, 20/21.3.2, 38/39.3.2




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6.5 In facilities where alcohol-based hand rub (ABHR) dispensers are installed, all the following conditions are met:

o o o

£ Corridors where dispensers are installed are at least 6 feet wide (clear dimension, exclusive of furniture, supplies, or equipment).

£ The maximum individual liquid dispenser capacity is no more than 40.5 fluid ounces (0.32 gal — or — 1.2 L) in individual rooms, corridors, and areas open to corridors. In suites of rooms, the maximum individual liquid dispenser capacity is no more than 68 fluid ounces (0.53 gal — or — 2 L).

£ The maximum individual aerosol dispenser capacity is no more than 18 oz. (0.51 kg). Multiple dispensers are spaced at least 4 feet clear apart.

£ Excluding one liquid or aerosol dispenser per room, not more than 10 gallons (37.8 L) of total combined fluid capacity — OR — 1,135 oz. (32.2 kg) of total combined aerosol capacity are present in a single smoke compartment outside a storage cabinet. Where a facility uses both types of ABHR dispensers the sum of the ratios of total fluids/10 gal + total aerosols/1,135 oz ≤ 1.0.

£ Stored ABHR fluid quantities greater than 5 gallons (18.9 liters) in a single smoke compartment are kept in a container or cabinet manufactured and labeled for such use, or in a wood cabinet built in conformance with NFPA 30:4.3.3(c). Storage cabinets include conspicuous lettering stating “FLAMMABLE — KEEP FIRE AWAY,” per NFPA 30, Flammable and Combustible Liquids Code.

£ ABHR dispensers are located at least 1 in. clear, horizontally and vertically, from any ignition source, including but not limited to the edges of switch and receptacle cover plates.

£ If dispensers are installed over a carpeted floor, the smoke compartment involved is fully protected with an approved supervised automatic sprinkler system.

£ ABHR solutions are ≤ 95% alcohol.

See AAAHC Chapter 8 for additional installation requirements 8.I.J / 416.44(b)(4).

NFPA 101: 20/21 .3.2.6

6.6 The operation of ABHR dispensers complies with all the following: o o o

£ Dispensers do not release their contents without activation by manual or touch-free means.

£ Touch-free activation does not occur until an object is within 4 in. of the sensing device.

£ The object activating touch-free operation initiates only a single dispensing of solution, regardless of the time kept in the sensing area.

£ The dispenser delivers no more solution than required for proper hand sanitation, per manufacturer’s label instructions.

£ The dispenser is designed and installed to avoid accidental or malicious activation.

£ Each dispenser is tested per manufacturer instructions each time it is refilled.

NFPA 101: 20/21 .3.2.6



Physical Environment Checklist 7. Medical Gases

C NC NA

GENERAL — NEW and EXISTING ASCs

7.1 Nonflammable gases stored in total quantities up to 300 cubic ft. are not required to be in an enclosure but must be secured against falling or being knocked over and protected from physical harm from impact with heavy movable equipment.

o o o

NFPA 99: 11.3, 11.6.2

7.2 Quantities of nonflammable gases greater than 300 cubic ft. but less than 3,000 cubic ft. are stored in an exterior enclosure and/or in an enclosed interior space. The walls, floors, ceilings, roofs, doors, interior finish, and shelves of the storage location are built of noncombustible or limited- combustible materials with doors (or gates outdoors) that can be secured against unauthorized entry. Oxidizing gases are not stored in the same enclosure as flammable liquids, gases, or vapors. Oxidizing gases are separated from combustible materials in at least one of the following ways:

o o o

£ A minimum distance of 20 ft., unless the room is protected by an approved sprinkler system in which case a minimum 5-ft. separation is acceptable.

£ Either the oxidizing gases, or the combustible materials, are stored in a 30-minte rated noncombustible cabinet.

NFPA 99: 11.3

7.3 Storage locations for quantities of nonflammable gases greater than 3,000 cubic ft. comply with item 7.20 below.

o o o

NFPA 99: 5.1.3.3.2-3, 11.3

7.4 Gas cylinder and liquefied gas container storage is in accordance with item 7.20 below. o o o

NFPA 99: 5.1.3.5.12, 11.3

7.5 Cylinder and container storage locations are maintained at temperatures ≤ 130°F. o o o

NFPA 99: 5.1.3.5.12, 11.3

7.6 Medical gas storage location doors/gates have a precautionary sign, legible from 5 ft. away stating:

CAUTION: OXIDIZING GAS(ES) STORED WITHIN NO SMOKING

o o o

NFPA 99: 11.3.4.2

ALL PIPED GAS AND VACUUM SYSTEMS (CATEGORY 1 & 2)

7.7 Compressed gas storage for other than oxygen and medical air have the door(s) labeled as follows:

Positive Pressure Gases NO Smoking or Open Flame Room May Have Insufficient Oxygen Open Door and Allow Room to Ventilate Before Entering

o o o

NFPA 99: 5.1.3.1.8




C NC NA

7.8 Compressed gas storage containing only oxygen or medical air shall have the door(s) labeled as follows:

Medical Gases NO Smoking or Open Flame

o o o

NFPA 99: 5.1.3.1.9

7.9 Compressed gases cylinders and containers for volatile liquids are not kept near radiators, steam piping, and similar heat sources.

o o

NFPA 99: 5.1.3.2.9

7.10 Medical gas cylinders are not stored in a tightly closed space. o o

NFPA 99: 5.1.3.2.11

7.11 Medical gas cylinders, whether full or empty, are not stored in enclosures containing motor driven machinery.

o o

NFPA 99: 5.1.3.3.4.2

7.12 Compressed gas cylinders are not located in the same room or space as motor-driven compressed gas and vacuum equipment.

o o

NFPA 99: 5.1.3.3.1.2-3

7.13 Compressed instrument air and motor driven instrument air compressors may occupy the same room.

o o

NFPA 99: 5.1.3.3.1.4

7.14 Interior storage or supply rooms for oxidizing gases do not vent or open into the following locations:

o o o

£ Areas involved in critical patient care

£ Anesthetizing locations where moderate sedation, deep sedation, or general anesthesia is administered

£ Locations storing flammables

£ Rooms containing open electrical contacts or transformers

£ Storage tanks for flammable or combustible liquids

£ Engines

£ Kitchens

£ Areas with open flames

NFPA 99: 5.1.3.3.1.6

7.15 Cylinder and container storage locations are maintained at temperatures ≤ 130° F. o o o

NFPA 99: 5.1.3.3.1.7

7.16 Central supply systems for nitrous oxide and/or carbon dioxide are maintained in a temperature range between -20°F and 125°F.

o o o

NFPA 99: 5.1.3.3.1.8

7.17 Central oxygen supply systems with a total capacity connected and in storage of 20,000 cubic ft. or more outside of the facility comply with NFPA 55, Compressed Gases and Cryogenic Fluids Code.

o o o

NFPA 99: 5.1.3.3.1.9




7.18 Central nitrous oxide supply systems a total capacity connected and in storage of 3200 l or more comply with CGA G-8.1, Standard for Nitrous Oxide Systems at Consumer Sites.

o o o

NFPA 99: 5.1.3.3.1.10

7.19 Central inert gases supply systems, with a total capacity connected and in storage of 20,000 cubic ft. or more of compressed gas or cryogenic fluid at standard temperature and pressure, comply with CGA P-18, Standard for Bulk Inert Gas Systems at Consumer Sites.

o o o

NFPA 99: 5.1.3.3.1.13

7.20 Central supply and storage locations comply with all the following: o o o

£ Adequate free area is provided to safely move cylinders, equipment, and related items in and out of the location on hand trucks.

£ Doors or gates to storage locations are lockable or otherwise secured.

£ Exterior locations are provided with enclosing walls or fencing, constructed of noncombustible materials, with a minimum of two entry/exits.

£ Interior locations are fully enclosed (walls, floors, ceilings, doors) in 1-hour rated construction with noncombustible or limited-combustible interior finishes.

£ Interior locations are vented to the exterior as follows:

§ Natural ventilation is provided through two non-closeable louvered openings each with a free opening area of 72 SI, or 24 SI per 1000 cubic ft., whichever is greater.

§ Mechanical ventilation is provided through an exhaust system sized to remove 1 cfm per 5 cubic ft. of total stored gases volume but not less than 50 cfm. The exhaust air inlet is located within 1 ft. of the floor, the exhaust fan is powered by the essential electrical system, and room make-up air is provided. The exhaust ducts are made of noncombustible material.

£ Interior locations are heated by indirect means (e.g., steam, hot water) if heat is required.

£ The locations include racks, chains, or other fastenings to secure all cylinders from falling, whether connected, unconnected, full, or empty.

£ Racks, shelves, and supports, where provided, are made of noncombustible or limited- combustible materials.

£ Electrical devices are located to avoid physical damage from movement or falling of cylinders.

NFPA 99: 5.1.3.3.2, 9.3.7.5.2, 9.3.7.5.3

7.21 Motor driven sources of compressed gases or vacuum are adequately vented to prevent overheating.

o o o

NFPA 99: 5.1.3.3.3.2

7.22 Exterior medical gas supply locations have ventilation openings at the base of each freestanding wall to allow free circulation of air within the enclosure.

o o o

NFPA 99: 5.1.3.3.3.3

7.23 Control equipment that is remote from the supply system is located inside a secure enclosure to prevent unauthorized access. Such enclosure provides adequate maintenance and repair working clearances and does not communicate with combustible or flammable materials.

o o o

NFPA 99: 5.1.3.4




C NC NA

7.24 Central supply systems for high pressure cylinder and/or liquid gas container systems comply with NFPA 99: 5.1.3.5.10 – 5.1.3.5.13.

o o o

£ Cylinder manifolds for gas cylinders per NFPA 99: 5.1.3.5.10

£ Manifolds for cryogenic liquid containers per NFPA 99: 5.1.3.5.12

£ Bulk cryogenic liquid systems per NFPA 99: 5.1.3.5.13

£ Medical air compressor systems per NFPA 99: 5.1.3.6

£ Medical–surgical vacuum producers per NFPA 99: 5.1.3.7

£ WAGD producers per NFPA 99: 5.1.3.8

£ Instrument air compressor systems per NFPA 99: 5.1.3.9

£ Proportioning systems for medical air USP per NFPA 99: 5.1.3.6.3.4

NFPA 99: 5.1.3.5

7.25 Centrally supplied patient-use gases are only piped to use points for the following: o o o

£ Direct respiration to patients

£ Clinical use in direct patient care

£ Devices directly related to patient respiration

£ Power for medical devices used directly on patients

£ Calibration of devices used in direct patient care

NFPA 99: 5.1.3.5.2

7.26 All positive pressure supply systems are provided with duplex line pressure regulators piped in parallel in compliance with the following:

o o o

£ Isolation valves are provided on the source side of each regulator.

£ Isolation or check valves are provided on the patient side of each regulator.

£ Pressure indicator(s) are located downstream of each regulator or immediately downstream of the isolating valves for the regulators.

£ The piping configuration allows either regulator to be serviced without interrupting supply.

£ Each regulator is sized for 100 percent of the peak calculated demand.

£ When used for cryogenic liquid systems, they are of balanced design.

NFPA 99: 5.1.3.5.5.1




7.27 Interior supply locations provide pressure relief valves for all compressed gases compliant with the following:

o o o

£ Relief valves are made of brass, bronze, or stainless steel.

£ Except for compressed air systems with less than 3,000 cubic ft. capacity, they are vented to the outside of the building.

£ Each gas’ vent discharge line is no smaller than the size of the relief valve outlet.

£ Where two or more relief valves discharge into a common vent line, its internal cross-sectional area is no less than the combined cross-sectional area of all vent discharge lines served.

£ They do not discharge into locations where a potential hazard could result.

£ Vent lines are of the same construction as the gas distribution lines.

£ Vent lines are labeled similarly to their gas’ supply lines but include a clear indication they are relief vents.

£ Each/every discharge terminal is turned down and screened to prevent the entry of rain, snow, or vermin.

NFPA 99: 5.1.3.5.6.1-2, 5.1.3.5.6.4

7.28 Central supply systems provide a relief valve between each final line-pressure regulator and the source valve.

o o o

NFPA 99: 5.1.3.5.6.3

7.29 Where one central source supplies multiple distribution networks at different line pressures, each network complies with the following:

o o o

£ The medical air compressor system provides pressure regulators and master alarm actuators for each network served.

£ All central supply systems provide pressure regulators, relief valves, source valves, and master alarm actuators for each network served.

NFPA 99: 5.1.3.5.7

7.30 Local alarms are provided with clearly labeled visual status indicators and are installed per manufacturer specifications when exposed to exterior conditions for the following source equipment:

o o o

£ Manifold gas cylinders without reserve

£ Manifold gas cylinders with reserve supply

£ Manifold bulk cryogenic liquid systems

£ In-building emergency reserves

£ Instrument air headers

NFPA 99: 5.1.3.5.8




C NC NA

7.31 Headers serving central supply systems for gases or liquids include the following: o o o

£ Filter of gas-appropriate material to prevent the intrusion of debris into the manifold controls.

£ Shutoff valve between the nearest cylinder connection to the header and the point at which the header connects to the central supply system.

£ Indicator of the pressure of the header contents.

£ Check valve to prevent backflow into the header and to allow service of the header.

£ If intended for gas cylinder service, a check valve at each connection for the cylinder lead to prevent loss of gas in the event of damage to the cylinder lead or operation of an individual cylinder relief valve.

£ If intended for gas cylinder service, a pressure regulator to reduce the cylinder pressure to an intermediate pressure to allow the proper operation of the primary and secondary headers.

£ If intended for service with cryogenic liquid containers, a pressure relief valve.

£ Vent valves, if header vented to the exterior.

NFPA 99: 5.1.3.5.9

7.32 Medical air supply systems are used exclusively for patient respiration and calibration of respiratory devices and are supplied from any of the following:

o o o

£ Cylinders

£ Bulk containers

£ Medical air compressor sources

£ Oxygen and oil-free, dry nitrogen

NFPA 99: 5.1.3.6.1-2

7.33 Medical air compressors are located indoors in a dedicated mechanical equipment room with proper ventilation and temperature controls as necessary to comply with manufacturer specification for operating environment.

o o o

NFPA 99: 5.1.3.6.3.1




7.34 Medical air compressor equipment includes the following components: o o o

£ A source valve

£ A simplex compressor, at minimum

£ Pressure relief valves set at 50% above line pressure

£ Compressed air-drying equipment

£ Compressors and all downstream components are designed to prevent contamination of the air by oil, liquids, or other toxic substances

£ 1½-in. openings for direct inspection of the interconnecting shaft, and freely accessible and unobscured views of atmospheric vents closest to oil-containing sections

£ Anti-vibration mountings appropriate to the installation and manufacturer’s specifications for each component assembly

£ One or more aftercooler(s) with a condensate trap

£ Receivers equipped with a pressure relief valve, automatic drain, manual drain, sight glass, pressure indicator, and valves at intake/output ports and for bypass allowing compressors to supply the system directly

£ Receiver sized to prevent short-cycling of compressors

£ Medical air driers designed to provide air with dew point below 32°F at 50–55 psi at maximum demand

£ Medical air filters upstream of final line regulators, including a continuous visual indicator of filter elements’ effective life

NFPA 99: 5.1.3.6.3.2-10

7.35 Medical air compressor driers, filters, and regulators comply with the following: o o o

£ They are at least a simplex pump sized to serve overall maximum demand.

£ Manual valves are provided upstream and manual or check valves downstream to allow service for each individual component.

NFPA 99: 5.1.3.6.3.10

7.36 Only one aftercooler and one dryer-filter-regulator sequence assembly is open for airflow from the medical air compressor at a time.

o o o

NFPA 99: 5.1.3.6.3.10

7.37 Medical air compressors provide automatic alternation of compressor pumps or manual alternation on a set schedule. When the compressor pump(s) serving the system are incapable of meeting demand, additional pump(s) automatically activate. Each compressor motor is provided with dedicated electrical disconnect means ahead of the motor starter, a motor starting device, and overcurrent protection, control circuits that can shut down each motor without affecting others, and an automatic restart function not requiring manual intervention after a power interruption.

o o o

NFPA 99: 5.1.3.6.3.11




C NC NA

7.38 Medical air intakes comply with the following: o o o

£ They are located at least 25 ft. from potential sources of noxious or toxic fumes; at least 20 ft. above the ground; and at least 10 ft. from any door, window or other opening in a building.

£ Intake piping is of a type approved for clinical vacuum distribution (seamless copper or stainless steel).

£ Common air intakes (serving multiple pumps) are sized to minimize back pressure.

£ The intakes for each compressor pump include a valve, blind flange, or cap to isolate them from a common air intake, if used.

£ The end of (each) air intake turns down and is screened with a non-corrosive material.

£ In lieu of fresh air, a source of equal or better quality may supply a medical air compressor (such as “O.R. quality” filtered air), as long as it is available 24 hours per day 7 days per week.

NFPA 99: 5.1.3.6.3.12

7.39 Medical air systems monitor for conditions affecting air quality, appropriate to the source type, as follows:

o o o

£ High water level sensors in receivers served by liquid ring compressors — with water-cooled head, or water-cooled aftercoolers; upon sensing a fault condition the compressor system shuts down and activates a local alarm.

£ High liquid level sensors in each air-water separator serving a liquid ring compressor — upon sensing a fault condition the compressor system shuts down and activates a local alarm.

£ High temperature sensors at non-liquid ring compressors — upon sensing a fault condition the compressor system shuts down and activates a local alarm.

£ High temperature sensors at the immediate outlet of each compressor chamber — at pumps separating oil-containing chambers from the compressor chambers with open air dual-seals, upon sensing a fault condition the compressor system shuts down and activates a local alarm. These compressor types are also provided with coalescing filters with element change indicators, a charcoal absorber, and quarterly monitoring of gaseous hydrocarbons.

£ When backup or lag compressors are running, a local alarm activates that can only be reset manually.

NFPA 99: 5.1.3.6.3.13

7.40 Medical air quality monitoring is provided downstream of the medical air pressure regulators and upstream of the distribution piping as follows:

o o o

£ If dew point exceeds 35°F, a local alarm and all master alarms are activated.

£ If carbon monoxide exceeds 10 ppm, a local alarm is activated.

£ Both dew point and carbon monoxide monitors activate all related alarm panels upon power loss.

NFPA 99: 5.1.3.6.3.14

7.41 Medical air proportioning systems comply with all applicable requirements of NFPA 99: 5.1.3.6.3.15.

o o o

NFPA 99: 5.1.3.6.3.15




7.42 Medical-Surgical vacuum sources comply with the following: o o o

£ The source equipment is located indoors in a dedicated mechanical equipment area with proper ventilation and temperature controls as necessary to comply with manufacturer specification for operating environment.

£ The source equipment provides at least a simplex pump sized to meet the peak demand with the largest single pump out of service.

£ There is automatic backflow prevention from any on-cycle vacuum pumps through any off-cycle vacuum pumps.

£ A receiver is provided and equipped with a manual drain.

£ Shutoff valves or other means are provided to isolate each vacuum pump from the receiver and distribution piping and other vacuum pumps for maintenance or repair without loss of vacuum in the system.

£ Piping between the vacuum pump(s), discharge(s), receiver( s), and vacuum source shutoff valve is approved seamless copper or stainless steel, except brass, galvanized, or black steel pipe, which is permitted to be used as recommended by the manufacturer.

£ Flexible connectors are provided between vacuum pumps and intake/outlet piping.

£ A local alarm is provided to indicate a backup or lag pump is in use. Such signals must be manually reset.

£ A source valve is provided.

NFPA 99: 5.1.3.7.1-5

7.43 Medical vacuum sources provide automatic alternation of vacuum pumps or manual alternation on a set schedule. When the vacuum pump(s) serving the system are incapable of meeting demand, additional pump(s) automatically activate. Each pump motor is provided with dedicated electrical disconnect means ahead of the motor starter, a motor starting device, and overcurrent protection, control circuits that can shut down each motor without affecting others, and an automatic restart function not requiring manual intervention after a power interruption.

o o o

NFPA 99: 5.1.3.7.6

7.44 Vacuum source exhaust is located as follows: o o o

£ It discharges to the exterior, at least 10 ft. from any window, door, air intake, or other openings in a building.

£ The end of the exhaust pipe is turned down and covered with a non-corroding screen.

£ Exhaust piping is free of dips or loops that could trap condensate or oil, or such traps are provided with a drop leg and drain at the low point.

£ When multiple vacuum pumps share an exhaust line, means are provided to isolate each pump from the shared exhaust for maintenance purposes, and the common exhaust is sized to avoid back pressure.

NFPA 99: 5.1.3.7.7




C NC NA

7.45 Waste Anesthetic Gas Disposal (WAGD) sources may be provided by any of the following: o o o

£ Medical-surgical vacuum source equipment sized to accommodate the additional volume and to assure the concentration of oxidizers in the receiver is maintained below 23.6%.

£ A dedicated WAGD source with one or more WAGD producers consisting of vacuum pump(s) manufactured for the specific purpose (lubricants and sealants are inert in the presence of oxidizing gases and halogenated anesthetics), a venture driven by a reliable source other than medical air or by specially configured fans/blowers.

£ All WAGD sources comply with NFPA 99: 5.1.3.8 requirements.

NFPA 99: 5.1.3.8

7.46 When WAGD is provided by the medical-surgical vacuum system, the pipe serving the WAGD inlet connects to the vacuum line at least 5 ft. from the nearest medical-surgical vacuum inlet.

o o o

NFPA 99: 5.1.3.8.3

7.47 Central source equipment for a WAGD system is provided with a local alarm that indicates when a backup or lag producer is running. Control circuits are configured such that the shutdown of one producer does not affect others. Motorized pumps will automatically restart (without manual intervention) following power loss. WAGD system exhaust to the exterior as required for vacuum sources.

o o o

NFPA 99: 5.1.3.8.4-6

7.48 Instrument air supply systems comply with NFPA 99: 5.1.3.9. o o o

NFPA 99: 5.1.3.9

7.49 Valves serving piped gas/vacuum systems comply with the following: o o o

£ Valves not contained in zone valve boxes are properly labeled and secured against inappropriate use.

£ Shutoff valves accessible to other than authorized personnel are installed in valve boxes with frangible or removable windows large enough to allow manual operation of valves.

£ NEW or replacement valves are of quarter turn, full ported, ball type; made of brass or bronze; have a handle indicating open or closed; and are three-piece assemblies permitting in-line serviceability.

NFPA 99: 5.1.4.2

7.50 Valves for vacuum and WAGD systems are at minimum ball or butterfly type. o o o

NFPA 99: 5.1.4.2

7.51 Source valves are provided as follows: o o o

£ At the immediate connection of each source equipment assembly to the piped distribution system.

£ In the immediate vicinity of the source equipment.

£ Labeled to the effect “SOURCE VALVE FOR THE (SOURCE NAME).”

NFPA 99: 5.1.4.4




7.52 A main line shutoff valve is provided in the main supply line inside the building, except as follows:

o o o

£ When the source and source valve are inside the building, a main line shutoff is not required.

£ When the source equipment system is physically mounted to the exterior wall of the building and the distribution pipe enters the building in the immediate vicinity of the source valve, a main line shutoff is not required.

NFPA 99: 5.1.4.5

7.53 Main line valves are as follows: o o o

£ Located to allow access by authorized personnel only.

£ Located outside the source room or enclosure, or where the main line enters the building.

£ Labeled to the effect “MAIN LINE VALVE FOR THE (GAS/VACUUM NAME) SERVING (NAME OF THE BUILDING).”

NFPA 99: 5.1.4.5

7.54 Riser valves are as follows: o o o

£ Located next to the riser connection to the main line, in the riser itself.

£ Labeled to the effect “RISER FOR THE (GAS/VACUUM NAME) SERVING (NAME OF THE AREA/BUILDING SERVED BY THE PARTICULAR RISER).”

NFPA 99: 5.1.4.6

7.55 Service valves are as follows: o o o

£ Located to allow maintenance or modification of lateral branch piping.

£ Located in branch piping prior to any zone valve box.

£ Located behind a locked access door, or locked open above a ceiling, or locked open in a secure area.

£ Labeled to the effect “SERVICE VALVE FOR THE (GAS/VACUUM NAME) SERVING (NAME OF THE AREA/BUILDING SERVED BY THE PARTICULAR VALVE).”

NFPA 99: 5.1.4.7




C NC NA

7.56 All station inlets/outlets are supplied through zone valves as follows: o o o

£ Zone valves are placed on opposite side of wall from the inlets/outlets they control.

£ Zone valves only serve inlets/outlets on the same story.

£ Zone valves are not located inside a room with station inlets/outlets they control.

£ Zone valves are easily operable from a standing position in a corridor or passage.

£ Zone valves do not affect the delivery of gases/vacuum to any other zone.

£ Zone valves include a pressure/vacuum indicator on the outlet/inlet side of the valve.

£ Zone valves locations are freely visible and not installed behind doors that could shield them from view.

£ A zone valve is located immediately outside each critical care area and location where anesthesia is administered as moderate sedation or greater, in each medical gas or vacuum line — located for ready access in an emergency.

£ Labeled to the effect “ZONE VALVE FOR THE (GAS/VACUUM NAME) SERVING (NAME OF THE ROOM OR SPACE)”.

NFPA 99: 5.1.4.8

7.57 In-line shutoff valves are optional and provided as follows: o o o

£ They are permitted to isolate or shut off piping for service of individual rooms or areas.

£ They are located in a restricted area and locked open.

£ Labeled to the effect “VALVE FOR THE (GAS/VACUUM NAME) SERVING (ROOM OR AREA)”.

NFPA 99: 5.1.4.9

7.58 Valves for future connections are optional and provided as follows: o o o

£ They are located in a restricted area and locked closed.

£ Labeled to the effect “FUTURE USE VALVE FOR THE (GAS/VACUUM NAME)”.

NFPA 99: 5.1.4.10

7.59 NEW or replacement check valves are of brass or bronze construction, have in-line serviceability, do not have threaded connections, and have threaded purge points 1/8 in. NPT.

o o o

NFPA 99: 5.1.4.11

7.60 Station outlets/inlets comply with the following: o o o

£ Each is gas specific and without interchangeable parts.

£ Each outlet has primary and secondary valves.

£ Each inlet has a primary valve and is permitted to have a secondary valve.

£ The secondary valve closes automatically when the primary is removed.

£ Each is legibly identified by the name and chemical symbol of the gas/vacuum supplied and non-standard operating pressure as applicable.

NFPA 99: 5.1.5.1-8

7.61 When multiple inlets/outlets are installed adjacent to each other, they are spaced adequately to allow simultaneous use with various types of accessory fittings.

o o o

NFPA 99: 5.1.5.14




7.62 Surface-mounted medical gas rails (MGR) assemblies comply with the following: o o o

£ They do not penetrate any fixed surfaces or construction.

£ Station outlets and/or inlets are not located on the ends of them.

NFPA 99: 5.1.7

7.63 Pressure/vacuum indicators are provided as follows: o o o

£ Adjacent to the alarm actuator (initiating device) for the source main line pressure and vacuum master alarms.

£ At or in area alarm panels to indicate pressure/vacuum for each system monitored at the panel.

£ On the station outlet/inlet side of zone valves.

NFPA 99: 5.1.8

7.64 All master, area, and local alarm systems for medical gas and vacuum system include the following:

o o o

£ Separate visual indicators for each condition monitored, except for local alarm displays on the master alarm(s) that only indicate a trouble condition with any aspect of each monitored source equipment.

£ Visual alarm indicators that remain in alarm until the trouble has been resolved.

£ Cancellable audible indication of each alarm condition, with reactivation if a NEW trouble signal is received.

£ The means to visually indicate a lamp or LED failure.

£ Visual and audible indication of a particular alarm-actuator malfunction.

£ Clear labeling of each visual indicator’s meaning.

£ Clear labeling of each alarm panel’s area of coverage.

£ Power to all alarm components is provided through the Life Safety branch of Essential Electrical System (EES), except for local alarms that may be powered by the same EES branch service the source monitored.

£ Provision for automatic restarting of all electrical components following a power interruption of up to 10 seconds without creating false signals or the need for a manual restart.

NFPA 99: 5.1.9.1




C NC NA

7.65 A master alarm system is provided to monitor the function and status of sources of supply, reserve sources (if any), and the pressure in the main line from each gas/vacuum system source, including the following functions as applicable:

o o o

£ An alarm indication when or just before each source switches over from the primary supply to a reserve supply an indication when each bulk cryogenic liquid system main supply reaches one average day’s supply level.

£ An alarm indication when each bulk cryogenic liquid system reserve supply reaches one average day’s supply level.

£ An alarm indication when the pressure a cryogenic liquid storage unit serving as a reserve supply reaches a level too low to function.

£ An alarm indication when the main line pressure from any gas exceeds 20% above or below normal (High or Low) line pressure.

£ An alarm indication when a medical-surgical vacuum mail line pressure drops below 12-in. gauge HgV.

£ An alarm indication for each source equipment local alarm system indicating one or more monitored conditions is out of range or malfunctioning.

£ An alarm indication from each compressor when medical air dew point exceeds 35°F.

£ An alarm indication when WAGD vacuum level is below an effective level.

£ An alarm indication from each compressor when instrument air dew point is greater than -22°F.

£ An alarm indication when the primary or reserve production for a proportioning system stops.

NFPA 99: 5.1.9.2

7.66 An Area Alarm system is provided to monitor all medical gas, medical-surgical vacuum, and WAGD piped distribution systems serving rooms or areas where any anesthesia greater than moderate sedation is used, as well as critical care areas. The conditions resulting in an alarm indication at the panel include the following:

o o o

£ A change in line pressure for each medical gas system serving the area/room greater than 20% above or below normal.

£ A drop in medical-surgical vacuum pressure below 12 in. gauge HgV.

NFPA 99: 5.1.9.3

7.67 Alarm sensors for Area alarms are located as follows: o o o

£ Critical care area sensors are on the use-side of each gas/vacuum zone valve.

£ Sensors for locations where any anesthesia greater than moderate sedation is used are located on the use-side of each gas/vacuum zone valve serving a group (zone) of anesthetizing locations or at each individual room in it.

NFPA 99: 5.1.9.3, 5.1.9.5

7.68 Local alarm sensor locations and monitored conditions are as described in NFPA 99: 5.1.9.5. o o o

NFPA 99: 5.1.9.5

7.69 Piping for positive pressure medical gas distribution is seamless copper of grades listed in NFPA 99: 5.1.10.1.4. Piping for vacuum and WAGD is seamless copper of grades listed in NFPA 99: 5.1.10.1.4, or stainless-steel tube.

o o o

NFPA 99: 5.1.10




7.70 Hose and tube connections, both metallic and nonmetallic, are no longer than necessary and do not penetrate or get concealed in walls, floors, ceilings, or partitions.

o o o

NFPA 99: 5.10.11.6

7.71 Medical gas and vacuum/WAGD piping is labeled by stenciling or adhesive labels that identify specific patient gases, support gases, and vacuum/WAGD system piping, including the following information:

o o o

£ Name of the gas or vacuum or the chemical symbol

£ Gas or vacuum system color code

£ Non-standard operating pressures

£ Medical gas piping is not painted

NFPA 99: 5.1.11.1, Table 5.1.11

7.72 Gas line labels are provided as follows: o o o

£ At least every 20 ft. on each pipe

£ At least once above every room they pass over

£ On both sides of walls or partitions penetrated

£ At least once on risers at every story

NFPA 99: 5.1.11.1.2

7.73 Installer performance testing is performed and documented before System Verification testing, per NFPA 99: 5.1.12.2 and includes:

o o o

£ Initial piping blow down

£ Initial pressure test

£ Initial cross-connection test

£ Initial piping purge test

£ Standing pressure test for positive pressure gases

£ Standing vacuum test for vacuum piping

NFPA 99: 5.12.2




C NC NA

7.74 System Verification testing is performed and documented by a third party (not the installer), per NFPA 99: 5.1.12.3 and includes:

o o o

£ Standing pressure

£ Cross-connection

£ Alarms

£ Piping purge

£ Piping particulates

£ Valves

£ Alarms

£ Final tie-in

£ Medical gas concentration

£ Labeling

£ Source verification

NFPA 99: 5.12.3

7.75 Inspection and testing operations are performed per NFPA 99: 5.1.14.2.3, including components and operations of the following systems, as applicable:

o o o

£ Source equipment and environmental conditions.

£ Manufactured assemblies employing flexible connection (s) between the user terminal and the piping system.

£ Medical gas and vacuum systems information and warning signs.

£ Medical gas and vacuum systems maintenance and record keeping.

NFPA 99: 5.1.14.2.3

7.76 Facilities have a routine maintenance program for their piped medical gas and vacuum systems.

o o o

NFPA 99: 5.1.5, 5.2.14

CATEGORY 1 GAS AND VACUUM SYSTEMS

7.77 Additional Category 1 Medical air compressor equipment provisions include the following: o o o

£ Duplex compressors, at minimum.

£ Backflow prevention between on- and off-cycle compressors.

£ Receiver sized to prevent short-cycling of compressors.

£ Aftercoolers (as provided) with individual condensate traps arranged as multiplex for overall compressor assembly, or one per compressor.

NFPA 99: 5.1.3.6.3.2-10




7.78 Additional Category 1 Medical air compressor driers, filters, and regulator provisions include the following:

o o o

£ They are at least duplexed with each component sized to serve overall maximum demand.

£ Manual valves are provided upstream and manual or check valves downstream to allow service of each individual component or of components arranged in series to create redundant parallel component branches.

£ Redundant relief valves are provided as necessary to assure all parallel component assemblies are protected.

NFPA 99: 5.1.3.6.3.10

7.79 Additional Category 1 Medical-Surgical vacuum source provisions include the following: o o o

£ The source equipment provides at least duplex pumps sized to meet the peak demand with the largest single pump out of service.

NFPA 99: 5.1.3.7.1-5

7.80 Additional Category 1 WAGD source provisions include the following: o o o

£ A dedicated WAGD source with two or more WAGD producers consisting of vacuum pumps manufactured for the specific purpose (lubricants and sealants are inert in the presence of oxidizing gases and halogenated anesthetics), a venture driven by a reliable source other than medical air or by specially configured fans/blowers.

NFPA 99: 5.1.3.8

7.81 Additional Category 1 requirements for master, area, and local alarm medical gas and vacuum systems include:

o o o

£ The master alarm system consists of at least 2 separate alarm panels located in two separate locations, with the following considerations/requirements:

§ One master alarm panel is located in the office or work area of the on-site individual responsible for the maintenance of the medical gas and vacuum/WAGD systems.

§ One additional master alarm panel is located in an area continuously observed from a regular staff work position.

§ A centralized computer system may be substituted for one of the master alarm panels required as long as its location, function, and capability complies with NFPA 99: 5.1.9.4 requirements.

§ Each of the required master alarms is wired separately for communication with the initiating devices (actuators), with no shared conductors or any other provision that could impair both panels simultaneously.

NFPA 99: 5.1.9




C NC NA

CATEGORY 2 GAS AND VACUUM SYSTEMS

7.82 Additional Category 2 requirements for master, area, and local medical gas and vacuum systems include:

o o o

£ Category 2 systems may be served by a signal combined master/area alarm panel under the following conditions:

o The combination panel displays both the source status indications of a master alarm system and the distribution line status indicators of the area alarm system.

o The alarm panel is located in an area of continuous observation while the facility is in operation.

o Pressure and vacuum actuators (sensors/initiating devices) are mounted at the source equipment, with pressure indicators located on the alarm panel.

NFPA 99: 5.2.9

7.83 The facility has an emergency plan to address measures taken during a loss of Medical Air, if applicable.

o o o

NFPA 99: 5.2.3.5

7.84 The facility has an emergency plan to address measures taken during a loss of medical-surgical vacuum, if applicable.

o o o

NFPA 99: 5.2.3.6

7.85 The facility has an emergency plan to address measures taken during a loss of WAGD, if applicable.

o o o

NFPA 99: 5.2.3.7



Physical Environment Checklist 8. Electrical System

C NC NA

ELECTRICAL EQUIPMENT

8.1 When two or more power receptacles supplied by a flexible cord are used to supply power to plug-connected components of a movable equipment assembly that is rack-, table-, pedestal-, or cart-mounted, all of the following conditions are met:

o o

£ The receptacles are permanently attached to the equipment assembly.

£ The sum of the ampacity of all appliances connected to the outlets does not exceed 75 percent of the ampacity of the flexible cord supplying the outlets.

£ The ampacity of the flexible cord is in accordance with NFPA 70, National Electrical Code.

£ The electrical and mechanical integrity of the assembly is regularly verified and documented.

£ Means are employed to ensure that additional devices or nonmedical equipment cannot be connected to the multiple outlet extension cord after leakage currents have been verified as safe.

NFPA 99: 10.2.3.6

8.2 The ASC has established policies and protocols for the type of test and intervals of testing for patient care-related electrical equipment used in the facility. All patient care–related electrical equipment used in patient care rooms is tested in accordance with NFPA 99: 10.3.5.4 or 10.3.6 before being put into service for the first time and after any repair or modification that might have compromised electrical safety.

o o

NFPA 99: 10.5.2.1

REQUIREMENTS COMMON TO TYPE 1, TYPE 2, AND TYPE 3 EES

8.3 All tests related to the electrical system are documented according to the following: o o

£ The record includes the date.

£ Rooms or areas tested, and the tests performed are identified.

£ Each problem or issue identified is identified.

NFPA 99: 6.3.4.2

8.4 Critical Care Areas are supplied by emergency power circuits downstream a single transfer switch and at least one circuit served by normal power.

o o

NFPA 99: 6.3.2.2.1.2

8.5 Overcurrent protective devices (such as circuit breaker panels or boxes) are not located in public access spaces, and are accessible to authorized personnel only.

o o

NFPA 99: 6.3.2.2.1.3




C NC NA

8.6 Electrical receptacles comply with the following: o o

£ All receptacles provide at least one, separate and dependable grounding pole.

£ All receptacles at all patient care positions are listed “hospital grade”.

£ Each patient position in general care areas is provided with at least 8 receptacles.

£ Each patient position in critical care areas is provided with at least 14 receptacles.

£ Each patient position in operating rooms is provided with at least 36 receptacles.

£ Receptacles located in rooms for pediatric use or access are listed as tamper-resistant or are provided with a listed tamper-resistant cover.

£ Laboratories are provided with at least one duplex receptacle every 3.3 ft. of instrument usage area.

NFPA 99: 6.3.2.2.6, 6.3.2.3; NFPA 70: 517.18

8.7 Wet procedure locations are provided with special protection against electrical shock through the use of GFCI receptacles or by the installation of an isolated power system that warns of a low current ground fault before disconnecting power when a higher threshold ground fault is reached.

o o o

NOTE: Operating rooms are considered to be wet areas, see also item 8.12.

NFPA 99: 6.3.2.2.8.2

8.8 The governing body has conducted a qualified risk assessment of the operating rooms and found some or all to not represent wet areas requiring special protection against electrical shock. Those not considered wet areas include:

o o o

NFPA 99: 6.3.2.2.8.4

8.9 The Essential Electrical System (EES) Type is appropriate to the areas served, as follows: o o

£ Critical care rooms are served by a Type 1 EES.

£ General care rooms are served by a Type 2 EES, or a Type 1 EES.

NOTE: Basic care rooms and non-patient care rooms do not need to be served by any Type of EES.

NFPA 99: 6.3.2.2.10

8.10 Self-contained rechargeable-battery-powered lights comply with the following: o o

£ The control and battery charging functions of the unit (fixture) are wired to the branch serving general lighting in the space.

£ The unit’s battery capacity provides lighting for 90 minutes or more during normal power loss.

£ The units are tested monthly for thirty seconds and annually for 90 minutes.

NFPA 99: 6.3.2.2.11




8.11 Self-contained battery-powered lights are provided at the following locations: o o

£ One or more in each location where deep sedation or general anesthesia is administered.

£ At the EES transfer switch location(s).

£ At interior locations of alternate power interior generator sets.

£ At locations of alternate power battery-based sources (SEPSS per NFPA 111).

NFPA 99: 6.3.2.2.11, 7.3; NFPA 110: 7.3; NFPA 111; 7.2

8.12 Isolated power systems (see item 8.7) include a Line Isolation Monitor (LIM) that indicates possible leakage or fault currents for all circuits served by the isolated power system, including the following components and features:

o o o

£ A green signal lamp, easily visible from the treatment location, is lighted when the system is properly isolated from ground, and an adjacent red signal lamp and an audible warning signal activate when the total hazard current from either isolated conductor to ground exceeds preset threshold values.

£ An ammeter is provided and is plainly visible indicating the total hazard current of the system with the “alarm on” zone at approximately the center of the scale.

£ A method is provided for silencing the audible alarm while leaving the red warning lamp activated. When the fault is corrected and the green signal lamp is reactivated, the audible alarm silencing circuit automatically resets, or an audible or distinctive visual signal indicates that the audible alarm is silenced.

£ A test switch is provided on the line isolation monitor to test its capability to operate (i.e., cause the alarms to operate and the meter to indicate in the “alarm on” zone). Use of the test switch activates both visual and audible alarm indicators. The test switch is a self-restoring type (system returns to normal upon release of momentary switch).

£ LIM circuits are tested at least monthly by actuating the LIM test switch. LIM circuits with automatic self-test and self-calibration capabilities are manually tested at least annually. All LIM circuits are tested immediately following any repair or renovation of the panel’s distribution system.

NFPA 99: 6.3.2.6.2, 6.3.4.1 o o

8.13 All receptacles in patient care spaces are tested as follows:

£ Visual inspection to confirm physical integrity

£ The continuity of the grounding circuit for each receptacle is verified

£ The correct polarity of hot and neutral connections for each receptacle is verified

£ The retention force of the grounding blade of each receptacle is tested and verified to be at least 4 oz.

£ Hospital grade receptacles are tested immediately following installation, servicing, and replacement

NFPA 99: 6.3.3.2, 6.3.4.1




C NC NA

REQUIREMENTS COMMON TO TYPE I AND 2 ONLY

8.14 Electrical power is supplied through an “essential electrical system” (EES), which derives power for the entire electrical system from a “normal source” and from a separate and independent “alternate source” when the normal source is interrupted. When the normal source is an on-site generating unit, the alternate source is either a separate generating unit or an external utility service.

o o

NFPA 99: 6.4.1.1.4-5

8.15 The alternate source of power for the EES is a generator set qualifying as Type 10, Class X, Level 1 from either of the following sources:

o o

£ Emergency and Standby Power Systems (generator sets) per the 2010 edition of NFPA 110.

£ Battery systems in full compliance with Article 700 of the 2011 edition of NFPA 70, National Electrical Code.

NFPA 99: 6.4.1.1.6.1, 6.4.1.2

8.16 Optional EES loads (those not specifically described as appropriate to an ASC, or serving loads not related to the ASC) are served by their own transfer switch, such that they will not be transferred onto the generating equipment if the transfer would overload the generating equipment.

o o

6.4.1.1.7.3

8.17 Emergency and Standby Power System (EPS) equipment (generator set) is selected, located, installed, and maintained in full compliance with the 2010 edition NFPA 110, including but not limited to the following:

o o

£ The generator set is located in a room dedicated to EES equipment and is separated from the remainder of the building by construction with a minimum 2-hour fire rating or is located in an exterior enclosure (or fixed housing integral with the generator set) capable of preventing the entrance of snow or rain and resisting high wind speeds.

£ EPS equipment and separate Stored Emergency Power Supply System (SEPSS) equipment may occupy the same interior space.

£ The locations housing EPS equipment are located to minimize the possibility of damage from flooding, including that from firefighting, sewer or storm water backup, and similar adverse events or consequences.

£ Interior EPS locations provide at least 36-in. working clearance on all sides as necessary to accommodate inspection, testing, or maintenance activities. Clearances are measured from the skid rails’ greatest extension in the direction of access.

£ The EPS is heated as necessary to maintain water jacket temperatures specified by the manufacturer.

£ Interior locations of EPS equipment are provided with adequate tempered airflow to assure the room does not exceed EPS manufacturer-specified temperature ranges when standing by or while running at rated load.

NFPA 99: 6.4.1.8-12, NFPA 110 7.2




8.18 Stored Emergency Power Supply System (SEPSS) equipment, if used, is selected, located, installed, and maintained in full compliance with the 2010 edition NFPA 111, including but not limited to the following:

o o o

£ Location

£ Working clearances

£ Lighting

£ Ventilation and environmental controls

NFPA 111

8.19 A remote annunciator, storage battery-powered, is provided away from the generator set location at a position readily observed by ASC personnel at a regular workstation. The annunciator monitors and indicates alarm conditions of the emergency or auxiliary power source related to proper function, reliability, and maintenance. Where a regular workstation may be unattended periodically, a secondary audible and visual signal, appropriately labeled, is provided at a continuously monitored location.

o o

NFPA 99: 6.4.1.1.17

8.20 Generator sets are maintained per NFPA 110, Chapter 8. Such maintenance includes but is not limited to:

o o

£ At least two sets of instruction manuals exist. One is kept near the equipment, and the other in a separate location.

£ Starting batteries are inspected weekly.

£ Diesel generator sets are exercised at least monthly for 30 minutes under loading that maintains minimum exhaust temperatures recommended by the manufacturer or is loaded at 30% of the nameplate rating for the full duration.

£ Diesel generators that do not achieve either form of required loading on the monthly tests undergo a more rigorous 90-minute test annually.

£ Spark ignited generator sets are exercised monthly for 30 minutes.

£ Transfer switches are exercised monthly.

£ Level 1 EPS undergo a test for the full duration of their Class or 4 hours, whichever is less, at least every 36 months.

8.21 Transfer switches comply with NFPA 99: 6.4.2.1.5, including but not limited to: o o

£ Automatic transfer switches are electrically operated and mechanically held. The switch transfers to alternate power, and back to normal power, automatically. If the transfer switch can be programmed for manual overrides, it is provided with a bypass feature to automatically retransfer in the event that the alternate source fails and the normal source is available. A test switch is provided on each automatic transfer switch that will simulate a normal power source failure to the switch. Two pilot lights, properly identified, are provided to indicate the transfer switch position. A method for safe manual operation of the automatic transfer switch is provided.

£ Non-automatic transfer devices are mechanically held. Operation is by direct manual or electrical remote manual control. Electrically operated switches get their control power from the source to which the load is being transferred. A method of safe manual operation is provided. Reliable mechanical interlocking, or an approved alternate method, is inherent in the design to prevent the unintended interconnection of any two separate sources of power. Clearly labeled pilot lights are provided to indicate the switch position.

NFPA 99: 6.4.1.2.5-7




C NC NA

8.22 The cover plates for the electrical receptacles (or the electrical receptacles themselves) arranged to be supplied with alternate power have a distinctive color or permanent marking so as to be readily identifiable.

o o

NFPA 99: 6.4.2.2.6

8.23 Circuitry is tested and maintained per NFPA 99: 6.4.4.1.2, including but not limited to: o o

£ Main and feeder circuit breakers

£ Main Feeder insulation resistance

£ Generator set starting batteries

£ Record keeping

NFPA 99: 6.4.4.1.2 – 6.4.4.2

ADDITIONAL REQUIREMENTS SPECIFIC TO TYPE 1 EES

8.24 The EES is divided into three branches: the Life Safety branch, the Critical branch, and the Equipment branch. Branches are separated at the transfer switch when more than one transfer switch is required and arranged to automatic transfer to the alternate source of power upon loss of normal power. Each branch of the EES is served by a separate transfer switch, unless the total continuous load on the EES is ≤ 150 kVA in which case a single transfer switch may serve all connected branches.

o o

NFPA 99: 6.4.2.2

8.25 The life safety branch and critical branch are kept entirely separate from all other wiring and equipment and do not enter the same raceways, boxes, or cabinets with each other or with other wiring. Wiring of the life safety branch and the critical branch is permitted to occupy the same raceways, boxes, or cabinets of other circuits in the following cases:

o o

£ In transfer equipment enclosures.

£ In exit or emergency luminaires (lighting fixtures) supplied from two sources.

£ In a common junction box attached to exit or emergency luminaires supplied from two sources.

£ For two or more emergency circuits supplied from the same branch.

NFPA 99: 6.4.2.2.6.1; NFPA 70: 517.30(C)




8.26 The life safety branch supplies power exclusively and comprehensively for the following lighting, receptacles, and equipment:

o o

£ Illumination of the means of egress, exit signs, and exit direction signs.

£ Fire alarms and auxiliary functions of fire alarm combination systems.

£ Medical gas alarm systems, unless connected to the Critical branch.

£ Communication systems, where used for issuing instruction during emergency conditions.

£ Task illumination at the generator set location, the battery charger for emergency battery- powered lighting unit(s) at the generator set location, and selected receptacles at the generator set location.

£ Elevator cab lighting, control, communication, and signal systems (if ASC relies on elevators).

£ Electrically powered doors used for building egress, if provided.

£ Alternate source generator set (EPS) components (unless connected to the output terminals of the generator), including:

▪ The transfer fuel pump

▪ Electrically operated louvers

▪ Other generator accessories essential for generator operation

NFPA 99: 6.4.2.2.3




C NC NA

8.27 The critical branch (which may be further divided into two or more branches) supplies power for task illumination, fixed equipment, selected receptacles, and selected power circuits serving the following required areas and functions (except as noted) related to patient care:

o o

£ Critical care areas that utilize inhalation anesthetizing gases: task illumination, selected receptacles, and fixed equipment.

£ Isolated power systems in special environments.

£ Patient care areas: task illumination and selected receptacles in:

▪ Infant nurseries, if present.

▪ Medication preparation areas.

▪ Pharmacy dispensing areas.

▪ Selected acute nursing areas.

▪ Psychiatric bed areas (omit receptacles), if provided.

▪ Nurses’ stations (unless adequately lighted by corridor luminaires).

▪ Additional specialized patient care task illumination and receptacles, where needed.

£ Nurse call systems.

£ Medical gas alarm systems, unless connected to the Life Safety branch.

£ Blood, bone, and tissue banks.

£ Telephone equipment rooms and closets.

£ Task illumination, selected receptacles, and selected power circuits for general care beds, angiographic labs, cardiac catheterization labs, hemodialysis rooms or areas, emergency room treatment areas (selected), human physiology labs, post-operative recovery rooms (selected).

£ Additional task illumination, receptacles, and selected power circuits needed for effective facility operation. Single-phase fractional horsepower motors may be connected to the critical branch.

£ Central medical suction systems, including controls (may be connected to either the critical branch or equipment branch).

NFPA 99: 6.4.2.2.4




8.28 The equipment branch supplies power to loads not identified as part of the emergency system that are important to the continued provision of patient care and treatment and continued ASC occupancy and function. Such loads fall into categories based on the priority and timing of connection to alternate power (where one switch serves multiple systems transfer for all loads is not delayed), as follows:

o o

£ Delayed-Automatic Connection (where multiple transfer switches are provided):

§ Task illumination and select receptacles in Patient care rooms, Medication preparation areas, Pharmacy dispensing areas, Nurses’ stations (unless adequately lighted by corridor luminaires)

§ Supply, return, and exhaust ventilating systems for airborne infectious isolation rooms

§ Sump pumps and other equipment required to operate for the safety of major apparatus and associated control systems and alarms

§ Smoke control and stair pressurization systems

§ Kitchen hood supply or exhaust systems, or both, if required to operate during a fire in or under the hood

£ Manual or delayed-automatic connection:

▪ Heating equipment to provide heating for general patient rooms.

▪ In instances where interruptions of power would result in elevators stopping between floors, throw-over facilities shall be provided to allow the temporary operation of any elevator for the release of passengers.

▪ Additional illumination, receptacles, and equipment shall be permitted to be connected only to the equipment branch.

NFPA 99: 6.4.2.2.5

ADDITIONAL REQUIREMENTS SPECIFIC TO TYPE 2 EES

8.29 The EES is divided in to two branches: the Life Safety branch, and the Equipment branch. Branches are separated at the transfer switch when more than one transfer switch is required and arranged to automatic transfer to the alternate source of power upon loss of normal power. Each branch of the EES is served by a separate transfer switch, unless the total continuous load on the EES is ≤ 150 kVA in which case a single transfer switch may serve all connected branches.

o o

NFPA 99: 6.5.2.2




C NC NA

8.30 The life safety branch supplies power exclusively and comprehensively for the following lighting, receptacles, and equipment:

o o

£ Illumination of the means of egress, exit signs, and exit direction signs.

£ Fire alarms and auxiliary functions of fire alarm combination systems.

£ Medical gas alarm systems.

£ Communication systems, where used for issuing instruction during emergency conditions.

£ Task illumination at the generator set location, the battery charger for emergency battery- powered lighting unit(s) at the generator set location, and selected receptacles at the generator set location.

£ Elevator cab lighting, control, communication, and signal systems (if ASC relies on elevators).

NFPA 99: 6.5.2.2.2

8.31 The equipment branch supplies power to loads not identified as part of the Life Safety branch that are important to the continued provision of patient care and treatment and continued ASC occupancy and function. Such loads fall into categories based on the priority and timing of connection to alternate power, as follows:

o o

£ Non-delayed-automatic connection (where multiple transfer switches are provided):

▪ Alternate source generator set (EPS) components, including: The transfer fuel pump, Electrically operated louvers, other generator accessories essential for generator operation.

£ Delayed-Automatic Connection (where multiple transfer switches are provided):

▪ Central medical suction systems, including controls (may be connected to either the critical branch of the emergency system or to the equipment system).

▪ Patient care and support work area lighting and power.

▪ Sump pumps and other equipment required to operate for the safety of major apparatus, including associated control systems and alarms.

▪ Compressed air systems serving medical and surgical functions, including controls (it shall be permitted to place such air systems on the critical branch); smoke control and stair pressurization systems.

▪ Kitchen hood supply and/or exhaust systems, if required to operate during a fire in or under the hood.

▪ Supply, return, and exhaust ventilating systems for airborne infectious/isolation rooms, protective environment rooms, exhaust fans for laboratory fume hoods, nuclear medicine areas where radioactive material is used, and ethylene oxide evacuation and inhalation anesthesia evacuation. (Where delayed automatic connection is not appropriate, such ventilation may be placed on the critical branch of the emergency system.)




£ Manual or delayed-automatic connection:

▪ Heating equipment to provide heating for operating, delivery, labor, recovery, nurseries, infection/isolation rooms, and pressure maintenance (jockey or make-up) pump(s) for water-based fire protection systems.

▪ Elevator(s) selected to provide service to patient, surgical, obstetrical, and ground floors during interruption of normal power (except elevator cab lighting, control, and signal system requirements, which are attached to the life safety branch of the emergency system).

▪ Supply, return, and exhaust ventilating systems for surgical and obstetrical delivery suites, intensive care, coronary care, nurseries, and emergency treatment spaces.

▪ Autoclaving equipment (immediate use sterilization equipment at minimum).

▪ Controls for equipment connected to the equipment system.

▪ Other selected equipment.

£ Electrically powered doors used for building egress, if provided.

NFPA 99: 6.5.2.2.3

8.32 The life safety and equipment branches are kept entirely independent of all other wiring and equipment.

o o

NFPA 99: 6.5.2.2.4

REQUIREMENTS TYPE 3 EES ONLY

NOTE: The 2012 edition of NFPA 99 does not identify any circumstance under which a NEW Type 3 EES may be used in an ASC. EXISTING systems may continue in use but require inspection testing and maintenance contained in the 2012 edition as described below.

8.33 NEW Type 3 EES alternate power sources are classified as Type 10, Class X, Level 2 generator sets per NFPA 110.

o o

NFPA 99: 6.4.1.1.6.2

8.34 The EES provides alternate power for Life Safety branch loads with a minimum duration of 90 minutes.

o o

8.35 The generator set and/or other alternate power source and associated equipment, including all appurtenance parts, is maintained as to be capable of supplying service within the shortest time practicable and within a 10-second interval from the loss of normal power.

o o

NFPA 99: 6.6.4.1.1.1




C NC NA

8.36 Generator sets are maintained per NFPA 110, Chapter 8. Such maintenance includes but is not limited to:

o o

£ At least two sets of instruction manuals exist. One is kept near the equipment and the other in a separate location.

£ Starting batteries are inspected weekly.

£ Diesel generator sets are exercised at least monthly for 30 minutes under loading that maintains minimum exhaust temperatures recommended by the manufacturer or is loaded at 30% of the nameplate rating for the full duration.

£ Diesel generators that do not achieve either form of required loading on the monthly tests undergo a more rigorous 90-minute test annually.

£ Spark ignited generator sets are exercised monthly for 30 minutes.

£ Transfer switches are exercised monthly.

8.37 The alternate source(s) of power are inspected, tested and maintained per manufacturer instructions and specifications, as well as per NFPA 110 requirements (generator sets) and/or per NFPA 111 (battery-based systems).

o o

NFPA 99: 6.6.4.1.1.2-3; NFPA 110; NFPA 111

8.38 Circuitry is tested and maintained per NFPA 99: 6.4.4.1.2, including but not limited to: o o

£ Main and feeder circuit breakers

£ Main Feeder insulation resistance

£ Generator set starting batteries

£ Record keeping

NFPA 99: 6.4.4.1.2 – 6.4.4.



Physical Environment Checklist 9. Interior Finish

C NC NA

9.1 Interior wall and ceiling finishes comply with NFPA 255, Standard Method of Test of Surface Burning Characteristics of Building Materials classifications as follows:

o o

£ Buildings not fully protected by a supervised automatic sprinkler system.

▪ Exits and enclosed corridors that are part of an exit pathway have wall and ceiling finishes of Class A or B.

▪ Other occupied area wall and ceiling finishes are Class A, Class B, or Class C.

▪ NEW interior floor finishes in exit enclosures are Class I or Class II.

£ Buildings fully protected by a supervised automatic sprinkler system.

▪ Exits and enclosed corridors that are part of an exit pathway have wall and ceiling finishes of Class B or C.

▪ Other occupied area wall and ceiling finishes are Class B or Class C.

▪ NEW interior floor finishes in exit enclosures are Class II minimum.

NOTE: Exposed heavy timber structural member surfaces comply as Class A, B, or C finishes.

NFPA 101: 10.2.5, 20/21.3.3, 38/39.3.3

9.2 The total combined area of bulletin boards, posters, and paper attached to walls does not exceed 20% of the wall surface they are attached to.

o o o

NFPA 101: 10.2.5.3, 20/21.3.3, 38/39.3.3




10. Fire Alarm Systems C NC NA

GENERAL

10.1 The installation of the fire alarm system includes the performance of all NFPA 72-required acceptance tests including documentation of compliance with the system design and construction requirements on the NFPA form “FIRE ALARM AND EMERGENCY COMMUNICATION SYSTEM RECORD OF COMPLETION” (figure 10.18.2.1.1 in the 2010 edition of NFPA 72). EXISTING system compliance may be documented using the NFPA form(s) current at the time of system installation.

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NFPA 72: 10.18

10.2 With NEW systems a copy of the Record of Completion is updated (kept current) to reflect changes to the system across time due to system maintenance and/or modification. The current record is stored in the building, and if not stored at the FACP itself, the location of the document is noted at the FACP. When the documents are kept in a separate cabinet or enclosure, it is labeled “FIRE ALARM DOCUMENTS.”

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NFPA 72: 10.18

10.3 Every fire alarm system includes the following documentation, in possession of an owner’s representative:

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£ Owners’ manual and manufacturer’s documentation for all system components

£ Final as-built drawings for the design of the system

£ For computer-based systems, a current copy of the installation-specific software

£ The written sequence of operation

NFPA 72: 10.18

10.4 Alarm notification is transmitted with both audible and visible signals in accordance with CABO/ ANSI A117.1, American National Standard for Accessible and Usable Buildings and Facilities. Visible signals are not required in exit stair enclosures, elevator cars, or EXISTING alarm systems. The entire lens of the visual signal (strobe) is mounted between 80 and 96 in. above the floor or within 6 in. of ceilings too low for that mounting range.

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NFPA 72: 9.6.3, 18.5.4

10.5 The visual display(s) for the alarm annunciation (usually at the FACP and/or one or more remote displays) indicate each floor of multistory buildings as separate zones. When floors are separated into multiple smoke compartments, for the purpose of relocating occupants away from the compartment of fire origin, each smoke compartment on the floor is indicated as a separate zone. When the system serves more than one building, each building is displayed separately.

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NFPA 72: 10.16

10.6 The operation of any fire alarm activating device automatically accomplishes, within 10 seconds, any control functions required of the device. Exception: A “Positive Alarm Sequence” is permitted to allow an initial 15-second delay following sensor or manual pull activation for qualified personnel to delay actuation of alarm-controlled functions for up to an additional three minutes while the source of signal is investigated to determine its validity and urgency. If either the initial 15 second or following three minutes passes without qualified personnel resetting the system, all alarm functions automatically and immediately activate. See NFPA 72: 9.6.3.4 for additional detail and requirements.

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NFPA 72:23.8, NFPA 101: 20/21.3.4, 38/39.3.4




10.7 Automatic fire department notification is transmitted by any of the following methods: o o

£ Auxiliary fire alarm system

£ Central station fire alarm system

£ Proprietary supervising station alarm system

£ Remote supervising station fire alarm system

£ EXISTING alarm systems may notify the fire department through a plan or method approved by the municipal fire authority.

NFPA 101: 9.6.3.4

10.8 Power for the system must be provided from two reliable sources, one the normal power system and the other a separate alternate source of power that automatically supplies the system when normal power is interrupted. If both sources of power are delivered through an uninterruptable power supply (UPS), it is powered through a dedicated branch circuit. Failure of any aspect of the UPS activates a trouble signal. The alternate power supply will replace an interrupted normal source within 10 seconds and has sufficient capacity to maintain the system in a non-alarm status for a period of at least 24 hours and/or in fully functioning alarm status (maximum connected load) for 15 minutes.

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NFPA 72: 10.5

10.9 When additional power supplies are provided (beyond that in the FACP) for other equipment essential to system operation, and located in a separate area(s) they are provided with dual sources of power similar to the those identified above (item 10.8). The locations of such additional power supplies are identified in the FACP location and/or on the FACP display.

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NFPA 72: 10.5

10.10 When the FACP, remote power supplies, or remote-control units are located in areas that are not continuously occupied, a smoke detector is provided in each corresponding unattended space.

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NFPA 72: 10.5

10.11 Where manual pull fire alarm stations are required/used in NEW alarm systems, they are located within 5 feet each exit doorway. With EXISTING alarm systems, the manual pull stations may be provided in the natural path of travel near each required exit or within 60 in. of the exit door opening.

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NFPA 101: 9.6.2

10.12 Dedicated manual pull alarm systems include additional pull stations such that no point in the fire area protected is more than 200 feet travel from the nearest pull station.

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NFPA 72: 17.14

10.13 Fire alarm systems relying on automatic detection (heat or smoke detection) or water-flow alarm (supervised sprinkler system) activation of the alarm signal also provide at least one manual pull station in an accessible and freely visible location.

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NFPA 101: 9.6.2

ASC SPECIFIC REQUIREMENTS

10.14 The ASC is provided with a manual pull fire alarm system. The alarm system is also actuated by all other detection systems otherwise required (smoke detection, etc.).

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NFPA 101: 20/21.3.3




C NC NA

10.15 A manual pull station is located inside the ASC adjacent to each exit discharge opening and/or egress door through the fire wall separating the ASC from non-ASC space areas.

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NFPA 101 9.6.3, 20/21.3.4

INSPECTION, TESTING & MAINTENANCE

10.16 When the fire alarm is out of service for more than 4 hours in a 24-hour period, the local fire authority will be notified and either of the following actions taken:

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£ The building is evacuated.

£ A fire watch is provided for all occupants left unprotected by the shutdown until the system is returned to service.

NFPA 101: 9.6

10.17 Personnel conducting inspecting, testing, and maintenance of the fire alarm system are qualified and certified for the task. Evidence of such qualification is available for inspection in the ASC.

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NFPA 72: 10.4.3

10.18 When system inspection, testing, and maintenance is not the responsibility of the system owner, the delegation of such responsibility is in writing and available for inspection.

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NFPA 72: 14.2.2

10.19 Required visual inspections of fire alarm systems include all of the following, as applicable to the system installed:

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£ Initial and Reacceptance inspection of all components identified in NFPA 72 Table 14.3.1.

£ Weekly inspection of specific unmonitored components identified in NFPA 72 Table 14.3.1.

£ Monthly inspection of specific components identified in NFPA 72 Table 14.3.1.

£ Quarterly inspection of specific components identified in NFPA 72 Table 14.3.1.

£ Semi-annual inspection of specific components identified in NFPA 72 Table 14.3.1.

£ Annual inspection of specific components identified in NFPA 72 Table 14.3.1.

NFPA 72: 14.3

10.20 Automated testing of fire alarm systems, when utilized, achieves the testing and frequency equivalent to that identified below (item 10.22). Failure of any component during an automatic test results in a trouble signal.

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NFPA 72: 14.2.7

10.21 When automatic testing is performed on at least a weekly basis by a remotely monitored FACP, manual testing frequencies listed in NFPA 72 Table 14.4.5 may be extended to an annual basis.

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NFPA 72: 14.4.5




10.22 Where automated testing is not utilized, required testing of fire alarm systems include all of the following as applicable to the system installed:

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£ Initial and Reacceptance testing of all components identified in NFPA 72 Table 14.4.5

£ Weekly testing of specific components identified in NFPA 72 Table 14.4.5

£ Monthly testing of specific components identified in NFPA 72 Table 14.4.5

£ Quarterly testing of specific components identified in NFPA 72 Table 14.4.5

£ Semi-annual testing of specific components identified in NFPA 72 Table 14.4.5

£ Annual testing of specific components identified in NFPA 72 Table 14.4.5

NFPA 72: 14.4.5

10.23 System maintenance is performed in accordance with manufacturer’s published specifications. Signal retransmission is tested at least every 12 hours, unless the means of retransmission is by public switched telephone network in which case testing is performed at least weekly.

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NFPA 72: 14.5

10.24 Paper or electronic media records of inspection, testing, and maintenance are retained for at least one year following completion of the next occurrence of the same. Such records include the date, activity frequency, name and address of property, name of individual performing the activity, name and address of approving agency(ies), and specific information pertinent to the activity as required by NFPA 72 section 14.6.2.4. [NOTE: NFPA 72, figure 14.6.2.4 provides a representative example of an Inspection and Testing form.]

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NFPA 72: 14.6

ADDITIONAL MULTI-TENANT BUILDING REQUIREMENTS

10.25 Fire alarm systems are provided for multi-tenant buildings (in addition to that required for the ASC) under any of the following circumstances:

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£ The overall building is more than two stories in height.

£ The building provides 5,000 SF or more of unoccupiable space on any floor above or below the floor of primary exit discharge.

£ The overall building provides 30,000 SF or more of occupiable space.

NFPA 101: 38/39.3.4

10.26 The fire alarm system, when required, for the multi-tenant building provides any of the following methods of alarm activation:

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£ A manual pull fire alarm system.

£ An automatic detection (smoke and/or fire sensors) system.

£ A supervised automatic fire sprinkler system throughout the building.

NFPA 101: 38/39.3.4




11. Corridor Separation C NC NA

11.1 Passages and corridors in NEW unsprinklered buildings used as exit access between the ASC suite perimeter and exit doors are enclosed (separated from occupancy areas) with a fire-resistance rating of at least 1 hour. Unprotected miscellaneous openings (mail slots, pass-through windows) occurring in corridor vision panels or doors are located no higher than half the ceiling height, and the sum of all such openings in any given room is 20 SI or less (80 SI or less in rooms protected throughout by a supervised automatic sprinkler system).

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NFPA 101: 20.3.6.2, 38.3.6



Physical Environment Checklist 12. Smoke and Fire Protection

C NC NA

12.1 The ASC is separated from adjacent occupancies/facilities by walls of 1-hour fire-resistive construction. Such walls are continuous (including through concealed spaces) from outside wall to outside wall, from one fire barrier to another, and from the floor slab to the roof/floor deck above. Doors in the fire separation wall are self-closing, positive-latching, and at least equivalent to a 13/4- in. thick, solid-bonded wood core. Doors in the fire separation remain closed except when in use.

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NFPA 101: 20/21.3.7.1

12.2 Openings in fire barriers for NEW air-handling ductwork or air movement are protected as follows:

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£ Approved fire dampers are provided where air ducts penetrate walls or partitions with a fire- resistance rating of 2 hours or more.

£ Approved fire dampers are provided in all air transfer openings in fire-rated walls or partitions.

NFPA 90A: 5.3; NFPA 101: 8.3.5.7, 9.2.1

12.3 Where air ducts extend through only one floor level and serve both adjacent floors, the ducts are enclosed in fire-rated shafts, or fire dampers are installed at each duct penetration of the floor. Such fire-rated shafts have a 1-hour minimum fire rating or 2-hour minimum in buildings four stories or more in height. Fire dampers are not required in ducts where the airflow is upwards.

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NFPA 90A: 5.3

12.4 Pipes, conduits, bus ducts, cables, wires, air ducts, HVAC ducts, and similar building service equipment that pass through fire-rated barriers or smoke partitions are protected as follows:

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£ The space between NEW penetrating items and fire rated vertical and horizontal assemblies is protected by a firestop system or device tested in accordance with ASTM 814 or ANSI/UL 1479. Exceptions to this requirement include:

▪ Where penetrations are part of an assembly rated in accordance with ASTM E 119 or ANSI/UL 263.

▪ Where vertical penetrations are enclosed in shaft with fire rating equal or greater than of the floor system.

▪ Where concrete, grout, or mortar fills the full depth of the space between 6-in. diameter (maximum) cast-iron, copper, or steel pipes and an opening no larger than 1 SF in fire resistant concrete or masonry assemblies.

▪ Where firestopping materials protect the penetration of rated assemblies by steel cables, ferrous cables, copper cables, steel jacketed cable or wire, cast-iron pipe, steel pipe, copper pipe, or steel conduit or tubing under conditions specified in NFPA 101 section 8.3.5.1.1(4).

£ The space between EXISTING penetrating items and the fire rated vertical and horizontal assemblies is filled with a material (at both sides or for the full thickness of the barrier) capable of maintaining the required fire resistance of the barrier, or is protected by a specifically designed device.

£ If a sleeve or open-ended pipe is used for a NEW penetrating item, both the sleeve and item are tightly sealed at both sides of the barrier by a firestop system or device tested in accordance with ASTM 814 or ANSI/UL 1479.




C NC NA

£ If a sleeve or open-ended pipe is used for an EXISTING penetrating item, both the sleeve and item are tightly sealed at both sides of the barrier with a material capable of maintaining the required fire resistance of the barrier, or the sleeve is protected by a specifically designed device.

£ NEW insulation and coverings for pipes and ducts do not pass through a fire barrier unless such insulation or covering has been tested as part of a firestop system or device.

£ EXISTING insulation and coverings for pipes and ducts do not pass through a fire barrier unless such insulation or coating is a material capable of maintaining the required fire resistance of the barrier or is protected by a specifically designed device.

£ Where NEW piping penetrates a fire-resistive wall or floor assembly, combustible piping is not connected to non-combustible piping within 36 in. of the firestop system or device.

£ Unshielded couplings are not used to connect combustible piping to non-combustible piping unless the transition complies as a firestop system or device tested in accordance with ASTM 814 or ANSI/UL 1479.

£ Electrical outlet boxes and fittings are listed for use in fire resistant assemblies.

£ The space created by fire sprinkler heads penetrating a smoke partition is covered by a metal escutcheon plate.

NFPA 101: 8.3.5

12.5 An ASC 5,000 SF or larger (10,000 SF or larger in buildings fully protected with a supervised automatic sprinkler system) is divided into at least two smoke compartments. A separate adjacent occupancy can serve as the second smoke compartment if it is built to ASC enclosure standards (enclosing fire separation wall, detailed requirements for smoke separation wall), the ASC is smaller than 22,500 SF, and access from the ASC into the separate occupancy is unrestricted. An ASC in an unsprinklered building that does not provide multiple smoke compartments (ASC is smaller than 5,000 SF) is protected throughout by a comprehensive smoke detection system.

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NFPA 101: 20/21.3.7.2

12.6 Smoke barriers are of 1-hour (minimum) fire-resistive construction, and are continuous (including through concealed spaces) from outside wall to outside wall, from floor to floor, or from smoke barrier to smoke barrier or a combination thereof. At least 15 SF of low hazard area (corridors, treatment rooms, lounges, etc.) is provided in each smoke compartment for every 100 SF of total ASC area (all compartments). Doors in smoke barriers are self-closing (latch optional on cross corridor doors), are at least equivalent to a 13/4-in. thick, solid-bonded wood core, and door openings close with the minimum clearances necessary for proper operation (no undercuts, louvers, or grilles). Cross-corridor doors include a fire rated vision panel. Air transfer openings into a smoke compartment are protected with dampers appropriate to the rating of the smoke compartment walls and close upon activation of approved smoke detectors. Fully ducted HVAC systems in buildings protected with a comprehensive fire sprinkler system do not require smoke dampers at smoke wall penetrations.

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NFPA 101: 8.5, 20/21.3.7.3




12.7 Openings in fire-rated construction are protected as required for the fire resistance of the barrier in which they occur, as follows:

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£ Openings in fire barriers:

▪ 2-hour fire barriers have Door/vision panel Assemblies with at least a 1.5-hour (90-minute) rating.

▪ 1-hour fire barriers have Door/vision panel Assemblies with at least a 3/4-hour (45-minute) rating.

▪ 2-hour fire barriers have Window Assemblies with at least a 120-minute rating.

▪ 1-hour fire barriers have Window Assemblies with at least a 60-minute rating.

£ Openings in vertical shafts and stair enclosures:

▪ 2-hour vertical shafts have Door/vision panel Assemblies with at least a 1.5-hour (90-minute) rating.

▪ 1-hour vertical shafts have Door/vision panel Assemblies with at least a 1-hour (60-minute) rating.

▪ 2-hour vertical shafts have Window Assemblies with at least a 120-minute rating.

▪ 1-hour vertical shafts have Window Assemblies with at least a 60-minute rating.

£ Openings in horizontal exits:

▪ 2-hour horizontal exits have Door/vision panel Assemblies with at least a 1.5-hour (90-minute) rating.

▪ 2-hour horizontal exits have Window Assemblies with at least a 120-minute rating.

£ Openings in exit access corridors:

▪ 1-hour exit access corridors have Door/vision panel Assemblies with at least a 20-minute rating.

▪ 1-hour exit access corridors have Window Assemblies with at least a 60-minute rating.

£ Openings in smoke barriers:

▪ 1-hour smoke barriers have Door/vision panel Assemblies with at least a 20-minute rating.

▪ 1-hour smoke barriers have Window Assemblies with at least a 60-minute rating.

£ Openings in smoke partitions:

▪ 30-minute smoke partitions have Door/vision panel Assemblies with at least a 20-minute rating.

▪ 30-minute smoke partitions have Window Assemblies with at least a 30-minute rating.

NFPA 101: 8.3.4




C NC NA

12.8 Doors in fire-rated construction are protected as required for the fire resistance of the barrier in which they occur, as follows:

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£ Doors in rated assemblies are self-closing and close with a positive latch when released from any position. If a rated door is held open, it is by a device that will automatically release it upon activation of an automatic sprinkler system, upon activation of the smoke and/or fire alarm system, and upon loss of power to the hold-open device.

£ Doors in stair/exit enclosures that are held open will automatically close upon activation of a smoke detector, upon loss of power to the hold-open device, or when manually pulled away from the hold-open device. The release of any door in an exit enclosure by a smoke detection device automatically releases all doors held open serving all floor levels from the same stair.

£ Fire-rated door assemblies consist of labeled (with fire rating) frames and labeled doors, with or without labeled vision panels. The rating of the overall assembly is determined by the lowest labeled component (door, frame, or vision panel).

£ All fire rated doors assemblies are visually inspected at least annually for signs of wear, damage, or other condition that could impair their performance and/or reliability. Such inspection is performed by individuals with demonstrated knowledge and understanding of the requirements and functional components of the rated assemblies being evaluated, and includes:

▪ Door and door hardware function and physical integrity.

▪ Condition of both door faces and swing/access clearances on both sides.

▪ Space on both sides of the door and the finished floor surface.

▪ The maximum gap between the closed door and frame jambs and top and/or between the strike side edges of pairs of doors (as applicable).

▪ Each door’s opening force and closing speed.

▪ Fire-rated doors and windows that are no longer in use have been removed and replaced by wall assemblies with fire/smoke resistive rating at least equal to the wall or assembly in which they occur.

▪ Repairs, adjustments, and/or other corrections are made without delay upon identification.

NFPA 80: 4; NFPA 101: 8.3, 20/21.3.7




12.9 Windows in fire-rated construction are protected as required for the fire resistance of the barrier in which they occur, as follows:

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NOTE: The vision panel and window fire ratings shown under item 2.7 relate to NEW installations. The minute ratings listed are for “W” labels (i.e., “120” indicates windows marked “W-120”). Windows in 1-hour rated fire barriers, exit access corridors, and smoke barriers are also permitted to be “OH-45.” Windows in 30-minute rated smoke partitions are also permitted to be “OH-20.” See NFPA 101 table 8.3.4.2 for additional window rating equivalencies.

£ NEW windows in fire-rated assemblies or walls use only labeled glazing materials set in labeled frames. NEW window assemblies are limited to the maximum size opening labeled on glazing panels used. The exposed area of individual fire glazing panels does not exceed 1,296 SI with a maximum dimension of 54 in., except as specifically tested and labeled for use. Glazing labels are permanent and are visible after installation.

£ NEW fire-rated door vision panels are limited to the size tested for the glazing/frame assembly.

£ Windows are not used in fire barriers required to have a rating greater than 1 hour. Windows in fire barriers comprise no more than 25% of the area of the fire barrier in the room in which they occur. Any door required to be self-closing (such as at stairway enclosures, exit passageway enclosures, horizontal exits, smoke barriers, or hazardous areas enclosures) if held open, is arranged to close automatically by the actuation of the fire alarm system, actuation of smoke detectors in the vicinity of the door opening, loss of power to the hold-open device, and when manually pulled away from the hold-open device.

£ EXISTING fire window/vision panel installations of wired glass (¼-in. thick min.) set in metal frames do not exceed 1,296 SI of glazed area.

NFPA 80:17; NFPA 101: 8.3, 20/21.2.2.4

12.10 Testing of Engineered Smoke Control Systems complies with all the following: o o o

£ NEW engineered smoke control systems are tested according to established engineering principles and meet performance requirements prior to acceptance.

£ After acceptance they are tested periodically according to established engineering principles.

£ Test documentation is maintained on the premises at all times.




13. Portable Fire Extinguishers C NC NA

13.1 Portable fire extinguishers are present and up to date. Portable fire extinguishers are provided in accordance with the 2010 edition of NFPA 10 and the following:

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£ Minimum rated single extinguisher: 2-A (2 units of A). Two water-type extinguishers rated 1-A may be counted as equivalent to one type 2-A extinguisher. Two 2.5-gal. water-type extinguishers may be counted as equivalent to one type 4-A extinguisher.

£ Maximum floor area per unit of A: 1,500 SF.

£ Where more than 5 gallons of flammable liquids are present in a room or area, an extinguisher rated 10-B will be located within 30 feet of travel from any point in that room or area, or an extinguisher rated 20-B will be located within 50 feet of travel from any point. NOTE: Extinguishers rated for both Class A and B fires may be used to satisfy both requirements at the same time.

£ Where extinguishers of lesser or different ratings are provided, they are not counted toward the minimum requirements for the ASC, and staff is aware of their limitations and/or special purpose.

£ Maximum floor area per single A-type extinguisher: 11,250 SF.

£ Maximum travel distance to nearest A-type extinguisher: 75 feet.

£ Fire extinguishers having a gross weight no greater than 40 pounds are installed so that the top of the fire extinguisher is not more than 60 in. above the floor.

£ Fire extinguishers having a gross weight greater than 40 pounds (except wheeled types) are installed so that the top of the fire extinguisher is not more than 42 in. above the floor. The clearance between the bottom of the fire extinguisher and the floor is at least 4 in.

£ Fire extinguishers are not exposed to temperatures outside the range shown on the extinguisher label.

£ Fire extinguishers are not hidden or obscured from view. Where visual obstruction cannot be completely avoided, obvious signage is provided to indicate the location.

£ Fire extinguishers are located along normal paths of travel and installed to be protected from damage.

£ Fire extinguishers, other than wheeled types, are installed on a hanger or in a bracket specifically designed for the purpose or kept in approved cabinets.

£ Fire extinguisher cabinets are kept unlocked or are provided with an emergency means of access and removal.

NFPA 10:5.4, 6.1, 6.2, 6.3; NFPA 101: 9.7.4.1, 20/21.3.5.3

13.2 Fire extinguishers are inspected when initially placed in service and at approximately 30-day intervals after that or at more frequent intervals when circumstances require. The 30-day interval inspections may be manual or by electronic monitoring device/system. Periodic inspection of fire extinguishers includes a check of at least the following items:

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£ Located in designated place.

£ No obstructions to access or visibility.

£ Operating instructions on nameplate are legible and facing outward and are not obscured by tags or labels.

£ Safety seals and tamper indicators are not broken or missing.

£ Fullness verified by weighing or “hefting.”




£ Examination for obvious physical damage, corrosion, leakage, or clogged nozzle.

£ Indicator status for non-rechargeable extinguishers with push-to-test indicators.

£ Fully charged with pressure gauge reading or indicator in the operable range or position.

£ Condition of tires, wheels, carriage (for wheeled units), hose, and nozzle checked.

NFPA 10: 7.1-2

13.3 Fire extinguishers undergo scheduled maintenance per manufacturer specifications by certified individuals at intervals of not more than one year, at the time of required hydrostatic tests, or when indicated by inspection or an electronic monitoring system.

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NFPA 10: 7.3

13.4 Any/all extinguishers removed for service or maintenance are immediately replaced by extinguishers of type and capacity at least equal to that/those being serviced or maintained.

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NFPA 10: 7.1

13.5 Rechargeable fire extinguishers are internally examined at 1 to 6-year intervals as indicated by NFPA 10 Table 7.3.1.1.2.

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NFPA 10: 7.3

13.6 All rechargeable fire extinguishers are recharged following any use and/or as determined necessary during inspection or maintenance.

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NFPA 10: 7.4

13.7 Rechargeable fire extinguishers undergo hydrostatic testing at 5 to 12-year intervals as indicated by NFPA 10 Table 8.3.1.

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NFPA 10: 8.3




14. High-Rise Buildings C NC NA

14.1 EXISTING buildings where the highest occupied floor level is more than 75 feet above lowest fire department access are protected throughout by an approved automatic sprinkler system (see item 2.3) or an engineered life safety system meeting the requirements of NFPA 101: 39.4.2.1 and approved by authorities having jurisdiction.

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NFPA 39: 4.2

14.2 NEW buildings where the highest occupied floor level is more than 75 feet above lowest fire department vehicle access are protected in accordance with NFPA 101: 11.8, as evidenced by all of the following:

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£ The building is protected throughout by an approved automatic sprinkler system (see item 2.3), including a control valve and water-flow detection device for every floor.

£ A Class I standpipe system (providing 2½-inch hose connections for fire department use) is provided throughout.

£ An emergency control station is provided (in a location approved by the fire department) containing all fire emergency panels, controls, annunciators, and status indicators.

£ Provisions are made for two-way voice communication between the central control station and every elevator car, every elevator lobby, and each floor level in every exit stair enclosure. EXCEPTION: When the fire department radio system is approved as being equivalent.

£ All electrically-powered fire safety devices and equipment, including electric fire pimps, Jockey pump, air compressor for dry-pipe and pre-action systems, command center emergency equipment and lighting, smoke control ventilation systems and at least one elevator, are powered through an emergency power supply system providing a minimum emergency power duration (fuel supply) of 60 minutes, supplied within 60 seconds of an interruption in normal power.

NFPA 101: 11.8, 38.4.2, NFPA 14: 3.3.14



Physical Environment Checklist 15. Building Services

C NC NA

15.1 EXISTING utility installations do not present a serious hazard to life. o o o

NFPA 101: 21.5.1

15.2 NEW utilities comply with NFPA 101 section 9.1., Utilities and are in accordance with the following:

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£ NFPA 54, National Fuel Gas Code

£ NFPA 58, Liquefied Petroleum Gas Code

£ NFPA 70, National Electrical Code

£ NFPA 110, Standard for Emergency and Standby Power Systems

£ NFPA 111, Standard on Stored Electrical Energy Emergency and Standby Systems

NFPA 101: 9.1, 20/21.5.1

15.3 NEW controllers for generators serving the ASC are monitored by the fire alarm system. NEW controllers for generators serving other than the ASC are either monitored by the fire alarm system, when provided, or at an attended position. All NEW generator controllers monitor for the following conditions, at minimum:

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£ Generator set running

£ Generator set fault

£ Transfer switch in non-automatic position

NFPA 101: 9.1, 20/21.5.1

15.4 EXISTING heating, air conditioning, ventilating ductwork, and related equipment are approved installations.

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NFPA 101: 9.2, 20/21.5.2

15.5 NEW heating, air conditioning, ventilating ductwork, and related equipment are designed and installed according to manufacturer’s specifications and the requirements of NFPA 90A, Standard for the Installation of Air-Conditioning and Ventilating Systems, or NFPA 90B, Standard for the Installation of Warm Air Heating and Air-Conditioning Systems. Ventilating or heat-producing equipment is designed and installed according to the requirements of NFPA 91, Standard for Exhaust Systems for Air Conveying of Vapors, Gases, Mists, and Noncombustible Particulate Solids; NFPA 211, Standard for Chimneys, Fireplaces, Vents, and Solid Fuel-Burning Appliances; NFPA 31, Standard for the Installation of Oil-Burning Equipment; NFPA 54, National Fuel Gas Code; or NFPA 70, National Electrical Code, as applicable.

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NFPA 101: 9.2, 20/21.5.2




C NC NA

15.6 NEW Heating, Ventilation, and Air Conditioning (HVAC) systems in ASCs comply with the 2008 edition ASHRAE 170, Ventilation of Health Care Facilities (without any subsequent amendments), including system design, installation, and performance requirements. Among the room/space- specific parameters established in the standard and present in all required spaces or areas in the facility are:

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£ ASC adheres to manufacturer’s instruction for use including humidity ranges for all equipment and materials (For additional resource information refer to CMS S&C: 15-27-Hospital, CAH & ASC and to the AAMI joint statement regarding relative humidity released January 2015. [http://s3.amazonaws.com/rdcmsaami/files/production/public/FileDownloads/NEWs/ Humidity_ in_OR_Joint_Communication_to_HDOs_January_2015.pdf]

£ Pressure relationships to all adjacent spaces

£ Minimum outdoor (fresh) air changes per hour

£ Minimum total air changes per hour

£ Spaces requiring 100% exhaust

£ Spaces permitted to recirculate room air through room units

£ Acceptable/required room relative humidity ranges

£ Acceptable/required room temperature ranges

NFPA 99: 9.3.1, ASHRAE 170

15.7 Fuel-fired heating devices are connected to chimneys or vents, get combustion air directly from the exterior, and completely separate combustion processes from interior air and spaces.

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NFPA 101: 9.2, 20/21.5.2

15.8 All heating devices immediately interrupt the supply of fuel/power and shut down in the event of excessive temperatures or ignition failure.

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NFPA 101: 9.2, 20/21.5.2

15.9 Listed unit heaters are permitted if suspended in areas not used for patient treatment or egress and mounted above and out of the reach of occupants and compliant with item 15.7.

o o o

NFPA 101: 9.2, 20/21.5.2

15.10 Portable space heating devices are not used in public, patient care, staff sleeping areas, or areas not attended by staff. The heating elements of portable space heaters do not exceed 212 degrees Fahrenheit.

o o

NFPA 101: 20/21.7.8

15.11 All HVAC controls and fire safety systems (including smoke and fire dampers) undergo acceptance testing under normal and emergency power (as applicable) to assure proper function.

o o

NFPA 90A: 3.4.7, 7.2

15.12 Smoke and fire dampers are inspected and tested one year after installation, and every four years thereafter. Where fusible links are used, they are removed during testing to simulate full closure.

o o o

NFPA 105: 6.5



Physical Environment Checklist 16. Vertical Conveyors

C NC NA

16.1 NEW elevators, escalators, and dumbwaiters are installed according to the requirements of American Society of Mechanical Engineers (ASME)/American National Standards Institute (ANSI) A17.1/CSA B44, Safety Code for Elevators and Escalators, including compliance with fire fighters’ emergency operations requirements.

o o o

NFPA 101: 9.4, 20/21.5.3

16.2 EXISTING elevators, escalators, and dumbwaiters are installed according to the requirements of ASME A17.3, Safety Code for EXISTING Elevators and Escalators. EXISTING elevators that travel less than 25 feet above or below the optimum level for emergency rescue do not need to conform to the fire fighters’ emergency operations requirements.

o o o

NFPA 101: 9.4, 20/21.5.3

16.3 All elevators equipped for fire fighters’ emergency operations are tested monthly, with documentation available on site.

o o o

NFPA 101: 9.4.6, 20/21.5.3

16.4 Vertical conveyors serving multiple levels of the building do not open into an exit enclosure. o o o

NFPA 101: 9.4, 20/21.5.3




17. Fire Emergency Plans C NC NA

14.1 All supervisory personnel have access to copies of a written plan for the protection of all persons in the event of a fire and for their evacuation to areas of refuge and from the building when necessary. All employees are periodically instructed and kept informed with respect to their duties under the plan. A copy of the plan is available at all times from the telephone operator’s position or at the security center. Employees are familiar with life safety procedures and devices.

o o

NFPA 101: 20/21.7.1

17.2 Fire drills include the transmission of a fire alarm signal and simulation of emergency fire conditions. Drills are conducted quarterly for each working shift to familiarize staff with signals and emergency action required under varied conditions. Drills conducted between 9:00 p.m. and 6:00 a.m. may use a coded announcement in lieu of the audible alarm. Patients are not required, and may not be required, to be moved during drills. All staff members are instructed in life safety (fire and evacuation safety) procedures and devices.

o o

NFPA 101: 20/21.7.1

17.3 The staff response to a fire emergency includes the removal of all occupants immediately threatened by the fire emergency, transmission of the fire alarm signal to warn other occupants and summon other staff, confinement of the effects of the fire, and relocation of patients as detailed in the facility’s fire safety plan. A thoroughly documented fire safety plan provides for:

o o

£ Use of and response to alarms, including use of a code phrase to ensure transmission of the alarm when the individual discovering the fire must immediately assist an endangered person, or if there is a malfunction of the fire alarm system. Upon hearing the code phrase, staff immediately activates the fire alarm system and then proceeds with their duties under the fire safety plan.

£ Transmission of alarm to dispatching authority (activation of the manual pull fire alarm system).

£ Isolation of fire (close doors as necessary to isolate fire area).

£ Evacuation of immediate area of the fire.

£ Evacuation of smoke compartment(s), if provided, and of the overall facility.

£ Preparation of the ASC and overall building for evacuation, including maintenance of exit egress and discharge to ensure their dependability and compliance with all egress requirements.

£ Extinguishing the fire.

NFPA 101: 20.7.2, 21.7.2



Physical Environment Checklist 18. Smoking

C NC NA

18.1 Smoking regulations are adopted and, at minimum, include the following: o o

£ Smoking in the facility is prohibited, and the policy is rigidly enforced.

£ Signs stating “NO SMOKING” are posted at all major entrances to the ASC.

£ Ashtrays/containers of noncombustible material are provided at exterior areas where smoking is permitted, as applicable.

£ No patients who are classified as “not responsible” are permitted to smoke without direct staff supervision.

NOTE: AAAHC accreditation standards prohibit smoking within an accredited facility.

NFPA 101: 20.7.4, 21.7.4, AAAHC Accreditation Standards




19. Furnishings and Decorations C NC NA

19.1 Draperies, curtains, privacy curtains, and other loosely hanging fabrics and/or films serving as furnishings (except curtains at showers) are in accordance with NFPA 701, Standard Methods of Fire Tests for Flame Propagation of Textiles and Films.

o o

NFPA 101: 10.3, 20/21.7.5.1

19.2 Except in buildings protected throughout by a supervised automatic fire sprinkler system, the components of NEWLY introduced upholstered furniture comply as “Class I” per NFPA 260, Standard Methods of Tests and Classification System for Cigarette Ignition Resistance of Components of Upholstered Furniture, or per ASTM E 1353, Standard Test Methods for Cigarette Ignition Resistance of Components of Upholstered Furniture.

o o o

NFPA 101: 10.3, 20/21.7.5.2

19.3 Except in buildings protected throughout by a supervised automatic fire sprinkler system, NEWLY introduced mattresses have a char length ≤ 2 in. per 16 CFR 1632, Standard for the Flammability of Mattresses and Mattress Pads (FF 4-72).

o o o

NFPA 101: 10.3, 20/21.7.5.2

19.4 Combustible decorations are not used unless they adhere to one of the following: o o

£ They have been rendered flame-retardant.

£ They are in accordance with NFPA 701, Standard Methods of Fire Tests for Flame Propagation of Textiles and Films.

£ They are similar to photographs and paintings, in quantities so limited as not to present a hazard of fire development or spread.

NFPA 101: 20/21.7.5.4

19.5 Except in rooms larger than 64 SF and protected as hazardous areas (enclosed in 1-hour minimum fire barriers or sprinklered) trash and soiled linen containers comply with the following:

o o o

£ Trash and soiled linen receptacles do not exceed 32-gal. capacity.

£ The combined capacity of soiled linen and trash containers in any given room is limited to ½ gallon per SF.

£ Mobile trash or soiled linen collection carts with capacity over 32 gal. may not be left unattended outside of areas protected as a hazardous area.

NFPA 101: 20/21.7.5.5



Physical Environment Checklist Life Safety Code (LSC)

Plan of Correction (PoC) To complete an AAAHC/Medicare Deemed Status Survey, your ASC must provide a written Plan of Correction (PoC) for each Life Safety Code (LSC) deficiency identified above. The evidence of correction for each deficiency must contain the following:

1. Action taken to correct each specific deficiency.

2. Description of how the actions will improve the processes that led to the deficiency cited.

3. The procedure for implementing the corrective actions.

4. Monitoring and tracking procedures to ensure that the PoC is effective in bringing the ASC into compliance, and that the ASC remains in compliance with the regulatory requirements.

5. The plan must include the title of the person responsible for implementing the acceptable plan of correction.

6. The administrator or another individual in a leadership role must sign and the date the written PoC.

7. A completion date for correction of each deficiency cited.

During the AAAHC/Medicare Deemed Status Survey, the AAAHC survey team will review the PEC and determine whether corrective actions have been implemented and documented for identified deficiencies, as appropriate.

Form Completed by Date

ASC Name

Street Address

City State ZIP Code

PEC

Item # Deficiency Description of Items (See 1-4 below)

Individual Responsible

for Correction

Administrator/Other Individual in

Leadership Role

Completion Date




WEL Designs PLC and AAAHC are not responsible for improper, incomplete, or out-of-context application of this document. Any individual or ASC using this PEC does so with an expressed understanding that all regulations and standards are subject to interpretation by authorities having jurisdiction — neither WEL Designs PLC nor AAAHC make any assurance as to the acceptability of interpretations necessarily contained in this PEC to any other authority. Life Safety Code® and NFPA 101® are registered trademarks of the National Fire Protection Association, Quincy, Massachusetts. The use or application of this PEC by anyone, including design or construction professionals, as a replacement or substitute for actual NFPA documents is strictly prohibited. © Copyright 2010 by WEL Designs, PLC (http://www.WELdesigns.com) All rights reserved.

Resources Accreditation Handbook for Medicare Deemed Status, v41


Standards Revisions

Revised Rating Methodology for AAAHC Standards

Medicare Certification Process 855B Enrollment Process

Understanding, Planning, and Preparing for a Medicare Deemed Status Survey with AAAHC

1095 Learn Portfolio

Toolkit Resources Crosswalk

Glossary

Resources

The 1095 Strong, quality every day philosophy provides ongoing client engagement through valuable

and meaningful tools, resources, and education the help organizations improve the quality and safety of care.



Standards Revisions The Accreditation Handbook for Medicare Deemed Status, v41 reflects an updated Standards rating process to match our other accreditation programs. The rating process is now more transparent and is intended to facilitate self-assessment of compliance. Updating the rating process resulted in the assignment of new identifiers to many Standards. In addition, some Standards have been combined and others have been divided, but most requirements of the Standards have not changed. While not a comprehensive list of every change from the prior version, this Appendix provides an easy reference to Standards that are new, significantly revised, or moved to different locations in the Handbook. A crosswalk of the AAAHC Standards and the Medicare Conditions for Coverage is also provided.

2017-18 Identifier

v41 Identifier Type of Change Additional Notes

2.I.E Deleted 2.I.J 4.I Relocated 42 CFR 416.41(b)(1) and (b)(2) 2.I.K 4.H Replaces former CMS requirement for a

hospital transfer agreement or all physicians holding admitting privileges

2.II.B 2.II.B - F Divided 2.II.G New Standard 3.D Previous requirements consolidated into 3.D

from multiple chapters

3.II.A - E 3.G and 3.H Previous requirements consolidated into 3.G. and 3.H

42 CFR 416.46

3.II.F and 3.II.G Deleted for redundancy 3.II.H, I, J, and K 7.II.N, O, P

and Q Relocated

4.K New CMS requirement based on revision to the CfC

42 CFR 416.41(b)(3)

5.I.E 5.I.G Footnote on page 44 of the 2017-18 Handbook is now element 2 of this Standard

The “ten elements” of quality improvement (QI) studies are no longer detailed in the Standard, but remain required components of QI studies

6.D.6 6.H.2 Revised by CMS but AAAHC has retained same language

42 CFR 416.47(b)(2)

8.I.P 7.II.B and 7.II.C

New requirements for the safety program Standard 7.II.C does not apply to initial surveys, or to reaccreditation surveys if none of the projects described in 7.II.B occurred in the last three years, or no such project is anticipated.

8.II.F.1-4 • 8.II.A.1 • 8.II.B, 8.II.I.1 • 8.II.D, 8.II.I.2 • 8.II.F.2 • 8.II.I.3

In 2019, CMS revised these requirements to permit biennial vs. annual review. AAAHC maintains the annual requirements.

• 42 CFR 416.54(a) • 42 CFR 416.54(b) • 42 CFR 416.54(c) • 42 CFR 416.54(d)(1)(ii) • 42 CFR 416.54(d)

9.D.1 9.B Supervisory privileges no longer required; appointment is sufficient

9.F 9.G Revised CMS requirement 42 CFR 416.42(a)(1)(ii)



Standards Revisions

2017-18 Identifier

v41 Identifier Type of Change Additional Notes

9.I, 10.I.L.1 Deleted for redundancy BLS requirement maintained at Standard 7.II.D

10.I.D New CMS requirement based on revision to the CfC

42 CFR 416.52(a)(1). Requirement for H&P for all patients within 30 days of procedure is maintained.

10.I.B 10.I.C Revised requirements for supervision of surgical services

10.I.E.3 10.I.H Revised CMS requirement 42 CFR 416.42(a)(1)(i) 10.I.R 10.I.R and

10.I.S • 10.I.R addresses procedure verification • 10.I.S addresses site marking and is

revised

10.I.S applies to surgeries and procedures involving level or laterality

10.II.A 10.II.B Expanded requirements for laser safety policies and procedures

11.I 11.M Revised Standard New Elements of Compliance 11.H New Standard The medication inventory is monitored

to track the presence or absence of high-alert medications and medications with confused drug names.

11.M

11.I and 11.J Divided to separate requirements regarding high-alert medications and those with confused drug names

“Confused drug names” also refers to look-alike/sound-alike medications

11.K New Standard Requirements for drug storage and security

11.N New Standard Standard applies to all organizations that store and handle vaccines for administration to patients and/or staff

12.A.1 12.D Edited to include multiple types of CLIA certificates

12.D does not apply if the State licensure or certification program is exempt from CLIA program requirements

12.D 12.E, F, G and H

Edited to separate requirements for different types of certificates

May not apply depending on services performed

12.F New Standard applicable if there is a state requirement for laboratory certification or licensure

12.F applies if State licensure or certification program is exempt from CLIA program requirements, or if CLIA and State licensure/ certification are both required

12.D 12.G and 12.H Revised to include state requirements for laboratory director qualifications

12.G applies if services referenced are provided, and State licensure program is exempt from CLIS program requirements, or if State and CLIA certification are both required.

12.M New Standard 12.M applies if proficiency testing is required by CLIA, the CLIA accrediting body, the state, and/or the organization's policies

Chapter 18 Teaching and Publication Activities May not apply depending on services provided Chapter 19 Research Activities

Chapter 20 Overnight Care and Services Chapter 24 Radiation Oncology Treatment Services



Standards Revisions Crosswalk: AAAHC Standards and Medicare Conditions for Coverage

Condition for

Coverage Reference

CMS Q-Tag

v41 Deemed Status Handbook Identifier

416.2 Q-0002 2.I.B 416.25 Q-0001 2.I.A 416.4 Q-0020 2.I.D 416.41 Q-0040 2.I.E 416.41 Q-0040 2.I.E.1 416.41 Q-0040 2.I.E.2 416.41 Q-0040 2.I.E.3 416.41(a) Q-0041 2.I.E.4 416.41(b)(1) Q-0042 4.I 416.41(b)(2) Q-0042 4.J 416.41(b)(3) Q-0042 4.K 416.42 Q-0060 10.I.A 416.42 Q-0064 2.II.N 416.42(a)(1)(i) Q-0061 10.I.H 416.42(a)(1)(ii) Q-0061 9.G 416.42(a)(2) Q-0062 9.L 416.42(b)(1) Q-0063 9.C.1 416.42(b)(2) Q-0063 9.C.2 416.43 Q-0080 5.I.A 416.43(a)(1) Q-0081 5.I.A.1 416.43(a)(2) Q-0081 5.I.A.2 416.43(b)(1) Q-0082 5.I.F 416.43(b)(2)(i) Q-0082 5.I.F.1 416.43(b)(2)(ii) Q-0082 5.I.F.2 416.43(c)(1) Q-0081 5.I.A.3 416.43(c)(1)(i) Q-0081 5.I.A.4 416.43(c)(1)(ii) Q-0081 5.I.A.5 416.43(c)(1)(iii) Q-0081 5.I.A.6 416.43(c)(2) Q-0082 5.I.F.3 416.43(c)(3) Q-0082 5.I.F.4 416.43(d)(1) Q-0083 5.I.H 416.43(d)(2) Q-0083 5.I.I 416.43(e) Q-0084 5.I.E 416.43(e)(1) Q-0084 5.I.E.1 416.43(e)(2) Q-0084 5.I.E.2 416.43(e)(3) Q-0084 5.I.E.3 416.43(e)(4) Q-0084 5.I.E.4 416.43(e)(5) Q-0084 5.I.E.5

Condition for Coverage Reference

CMS Q-Tag


416.44 Q-0100 8.I.F 416.44(a) Q-0101 8.I.F.1 416.44(a)(1) Q-0101 8.I.F.2 416.44(a)(2) Q-0102 8.I.F.3 416.44(b)(1) Q-0104 8.I.G 416.44(b)(4) Q-0105 8.I.J 416.44(b)(5) Q-0106 8.I.K 416.44(b)(5)(i) Q-0106 8.I.K.1 416.44(b)(5)(ii) Q-0106 8.I.K.2 416.44(b)(6) Q-0107 8.I.I 416.44(c) Q-0108 8.I.H 416.44(d) Q-0109 8.I.M 416.44(d)(1) Q-0109 8.I.M.1 416.44(d)(2) Q-0109 8.I.M.2 416.44(d)(3) Q-0109 8.I.M.3 416.44(e) Q-0110 7.II.D 416.45 Q-0120 2.II.A 416.45(a) Q-0121 2.II.A.1 416.45(a) Q-0121 2.II.L.1.c 416.45(b) Q-0122 2.I.N.6 416.45(b) Q-0122 2.II.H 416.45(c) Q-0123 2.II.O 416.46 Q-0140 3.G 416.46 Q-0140 3.G.1 416.46 Q-0140 3.G.2 416.46(a) Q-0141 3.H 416.46(a) Q-0141 3.H.1 416.46(a) Q-0141 3.H.2 416.46(a) Q-0141 3.H.3 416.47 Q-0160 6.A 416.47(a) Q-0161 6.B 416.47(b) Q-0162 6.G 416.47(b)(1) Q-0162 6.G.1 416.47(b)(2) Q-0162 6.H.2 416.47(b)(3) Q-0162 6.H.3 416.47(b)(4) Q-0162 6.H.4 416.47(b)(5) Q-0162 6.I 416.47(b)(5) Q-0162 6.I.3



Standards Revisions


CMS Q-Tag


416.47(b)(6) Q-0162 6.G.5 416.47(b)(6) Q-0162 9.G 416.47(b)(6) Q-0162 9.G.1 416.47(b)(7) Q-0162 6.G.6 416.47(b)(8) Q-0162 6.H.6 416.48 Q-0180 11.E 416.48(a) Q-0181 11.F 416.48(a)(1) Q-0182 11.F.1 416.48(a)(2) Q-0183 11.F.2 416.48(a)(3) Q-0184 11.F.3 416.49 Q-0200 12.A 416.49 Q-0200 13.A 416.49(a) Q-0201 12.B 416.49(a) Q-0201 12.C 416.49(a) Q-0201 12.D 416.49(b)(1) Q-0202 13.C 416.49(b)(1) Q-0203 13.D 416.49(b)(1) Q-0203 13.D.1 416.49(b)(1) Q-0203 13.D.2 416.49(b)(1) Q-0203 13.D.3 416.49(b)(1) Q-0203 13.D.4 416.49(b)(2) Q-0204 13.B 416.50 Q-0219 1.E 416.50 Q-0220 1.F 416.50(a) Q-0221 1.F.1 416.50(b) Q-0223 1.F.2 416.50(c) Q-0224 1.K 416.50(c)(1) Q-0224 1.K.1 416.50(c)(2) Q-0224 1.K.2 416.50(c)(3) Q-0224 1.K.3 416.50(d) Q-0225 1.M 416.50(d)(1) Q-0226 1.M.1 416.50(d)(2) Q-0226 1.M.2 416.50(d)(3) Q-0226 1.M.3 416.50(d)(4) Q-0225 1.M.4 416.50(d)(5) Q-0225 1.M.5 416.50(d)(6) Q-0225 1.M.6 416.50(e)(1)(i) Q-0227 1.B 416.50(e)(1)(ii) Q-0228 1.L 416.50(e)(1)(iii) Q-0229 1.J 416.50(e)(2) Q-0230 1.J.1 416.50(e)(3) Q-0230 1.J.2


CMS Q-Tag


416.50(f)(1) Q-0231 1.A.1 416.50(f)(2) Q-0232 1.C 416.50(f)(3) Q-0233 1.D 416.50(g) Q-0234 6.E 416.51 Q-0240 7.I.A 416.51(a) Q-0241 7.I.A.6 416.51(b) Q-0242 7.I.A.3 416.51(b) Q-0242 7.I.B 416.51(b)(1) Q-0243 7.I.C 416.51(b)(2) Q-0244 7.I.A.4 416.51(b)(3) Q-0245 7.I.B.1 416.52 Q-0260 10.I.F 416.52(a)(1) Q-0261 10.I.D 416.52(a)(1)(i) Q-0261 10.I.D.1 416.52(a)(1)(ii) Q-0261 10.I.D.2 416.52(a)(1)(iii) Q-0261 10.I.D.3 416.52(a)(2) Q-0262 10.I.F.1 416.52(a)(3) Q-0262 10.I.F.2 416.52(a)(4) Q-0263 10.I.F.3 416.52(b)(1) Q-0264 10.I.W 416.52(b)(2) Q-0264 10.I.X.1 416.52(c)(1) Q-0265 10.I.X 416.52(c)(2) Q-0266 10.I.X.2 416.52(c)(3) Q-0267 10.I.X.3 416.54 E-0001 8.II.A 416.54(a) E-0004 8.II.A.1 416.54(a) E-0004 8.II.I 416.54(a)(1) E-0006 8.II.A.2 416.54(a)(2) E-0006 8.II.A.3 416.54(a)(3) E-0007 8.II.A.4 416.54(a)(4) E-0009 8.II.A.5 416.54(b) E-0013 8.II.B 416.54(b)(1) E-0018 8.II.B.1 416.54(b)(2) E-0020 8.II.B.2 416.54(b)(2)(i) E-0020 8.II.B.2.a 416.54(b)(2)(ii) E-0020 8.II.B.2.b 416.54(b)(2)(iii) E-0020 8.II.B.2.c 416.54(b)(2)(iv) E-0020 8.II.B.2.d 416.54(b)(2)(v) E-0020 8.II.B.2.e 416.54(b)(3) E-0022 8.II.C 416.54(b)(4) E-0023 8.II.C.1 416.54(b)(4)(i) E-0023 8.II.C.1.a



Standards Revisions


CMS Q-Tag


416.54(b)(4)(ii) E-0023 8.II.C.1.b 416.54(b)(4)(iii) E-0023 8.II.C.1.c 416.54(b)(5) E-0024 8.II.C.2 416.54(b)(6) E-0026 8.II.C.3 416.54(c) E-0029 8.II.D 416.54(c) E-0029 8.II.I.2 416.54(c)(1) E-0030 8.II.D.1 416.54(c)(1)(i) E-0030 8.II.D.1.a 416.54(c)(1)(ii) E-0030 8.II.D.1.b 416.54(c)(1)(iii) E-0030 8.II.D.1.c 416.54(c)(1)(iv) E-0030 8.II.D.1.d 416.54(c)(2) E-0031 8.II.D.2 416.54(c)(2)(i) E-0031 8.II.D.2.a 416.54(c)(2)(ii) E-0031 8.II.D.2.b 416.54(c)(3) E-0032 8.II.E 416.54(c)(3)(i) E-0032 8.II.E.1 416.54(c)(3)(ii) E-0032 8.II.E.2 416.54(c)(4) E-0033 8.II.E.3 416.54(c)(5) E-0033 8.II.E.4 416.54(c)(6) E-0033 8.II.E.5 416.54(c)(7) E-0034 8.II.E.7 416.54(d) E-0036 8.II.F


CMS Q-Tag


416.54(d)(1)(i) E-0037 8.II.F.1 416.54(d)(1)(ii) E-0037 8.II.F.2 416.54(d)(1)(iii) E-0037 8.II.F.3 416.54(d)(1)(iv) E-0037 8.II.F.4 416.54(d)(1)(v) E-0037 8.II.F.5 416.54(d)(2) E-0039 8.II.G 416.54(d)(2)(i) E-0039 8.II.G.1.a 416.54(d)(2)(i)(A) E-0039 8.II.G.1.b 416.54(d)(2)(i)(B) E-0039 8.II.G.1.c 416.54(d)(2)(ii) E-0039 8.II.G.2 416.54(d)(2)(ii)(A) E-0039 8.II.G.2.a 416.54(d)(2)(ii)(B) E-0039 8.II.G.2.b 416.54(d)(2)(ii)(C) E-0039 8.II.G.2.c 416.54(d)(2)(iii) E-0039 8.II.H 416.54(e) E-0042 8.II.J 416.54(e)(1) E-0042 8.II.J.1 416.54(e)(2) E-0042 8.II.J.2 416.54(e)(3) E-0042 8.II.J.3 416.54(e)(4) E-0042 8.II.J.4 416.54(e)(4)(i) E-0042 8.II.J.4.a 416.54(e)(4)(ii) E-0042 8.II.J.4.b 416.54(e)(5) E-0042 8.II.J.5



Revised Rating Methodology for AAAHC Standards

To better assist organizations in conducting a self-assessment, AAAHC has revised the ratings and rating methodology as outlined below.

Revised Ratings Previous Rating Options for AAAHC Standards Revised Rating Options for AAAHC Standards

• Compliant (C) • Partially Compliant (PC) • Non-Compliant (NC) • Not Applicable (NA)

• Fully Compliant (FC) NEW • Substantially Compliant (SC) NEW • Partially Compliant (PC) • Minimally Compliant (MC) NEW • Non-Compliant (NC) • Not Applicable (NA)

Rating Methodology Rating options are defined by one of two factors when a Standard applies to your organization:

Centers for Medicare & Medicaid Services (CMS) Condition for Coverage (CfC) at the Standard level

Total number of Elements of Compliance (EOC) required; two scenarios exist.

• Rating process is designated by the presence of a CfC Q-tag at the Standard level

• All CfCs are rated in a binary manner [Fully Compliant (FC) and Non-Compliant (NC)] and all EOCs must be present to comply with the Medicare CfC.

• Example: refer to Standards 1.J, K, and L where different numbers of EOC exist but there is only one compliance rating option

• Note: when a CfC has subparts, the subparts become EOCs and may be split among two or more Standards. When this occurs, the number of Yes/No responses does not determine the overall rating. The determination of whether to cite a deficiency at the condition level remains dependent on the nature, extent or frequency of non-compliance.

• Scenario 1: One rating option is available based on the total number of EOCs required o Example: refer to Standard 1.A where

there are five Elements of Compliance and the rating option is based on a total of five elements

• Scenario 2: The total may vary when one or more EOCs are not applicable o Compliance rating that applies is based on

the number of EOCs that are applicable to your organization

o Example: refer to Standard 1.G where one or two EOCs may not apply. Five, four or three elements may apply and the compliance rating for each scenario is present

Compliance Ratings Compliance ratings are clearly defined and allow your organization to assess evidence during a self-assessment. The example below is for a Standard where five EOCs are required.



Non-Compliant








Medicare Certification Process

ASCs seeking Medicare certification for the first time must initiate the Medicare enrollment process before applying for a Medicare Deemed Status Survey. The process is described below and diagrammed on page 289.

The information in this section is not relevant to ASCs that are currently Medicare-certified.

The applicant must complete all requirements in order to obtain a provider agreement and CMS certification number (CCN) to receive payments from Medicare, including:

• 855B enrollment application

• Relevant State Agency (SA) forms for the particular provider type

• Accreditation survey documenting that the applicant meets all Medicare CfC and Accreditation Standards

• Notification that the accrediting organization (AO) is awarding accreditation and recommending deemed status for the facility.

The CMS Regional Office is responsible for reviewing all documents, issuing the provider agreement, and assigning a CCN. AAAHC has no role in this process.

Providers or suppliers will be required to submit an updated CMS-855B if six months has passed since the Medicare fee-for-service contractor sent its recommendation for approval to the state and a survey has not yet occurred.

The approval and effective date for Medicare certification is the date on which the RO has determined that the applicant ASC has met all federal requirements. AAAHC has no role in this determination.

For questions related to the enrollment process, please visit:

https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/MedicareProviderSupEnroll/index? redirect=/medicareprovidersupenroll/04_internetbasedpecos.asp

Obtaining a National Provider Identifier (NPI) Number CMS requires that all providers and suppliers obtain their NPI number prior to enrolling in Medicare. CMS utilizes various fee-for-service contractors to process 855B enrollment applications. These organizations collect the required enrollment information to submit to the CMS Regional Office. A Medicare fee-for-service contractor will not process the 855B enrollment application without the NPI and a copy of the NPI notification letter. Providers and suppliers can obtain their NPI by calling 1.800.465.3203 or at:

https://nppes.cms.hhs.gov/#/

855 Enrollment Process

1. The application to enroll as a Medicare provider can be found at:

https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads/cms855b.pdf

Download and complete the form.

• 855A is used for home health agencies (HHA), hospices, critical access hospitals (CAH), and hospitals (Providers). AAAHC does not accredit organizations that complete the 855A application.

• 855B (updated 7/2011) is used for ASCs (Suppliers).

2. Applicants must submit their completed 855B enrollment application, electronically or by hard copy, to the appropriate Medicare fee-for-service contractor. For information about Internet based Medicare enrollment, Provider Enrollment, Chain and Ownership System (PECOS), go to:

https://nppes.cms.hhs.gov/#/

This website provides instructional documents and information regarding completing a Medicare 855B enrollment application.

3. The Medicare fee-for-service contractor or carrier verifies the information on the 855B enrollment application and provides the State Agency (SA), the CMS RO, and the applicant ASC with a written recommendation for approval of enrollment within 30 calendar days.

https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/MedicareProviderSupEnroll/index?redirect=/medicareprovidersupenroll/04_internetbasedpecos.asp

https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads/cms855b.pdf



Medicare Certification Process

4. Applicants that submit an incomplete 855B application to Medicare will be required to resubmit the 855B with the missing information. Submission of an incomplete application will delay enrollment. In most cases, requests for additional information will be made within 60 calendar days of the initial receipt of the application by the Medicare fee-for-service contractor or carrier. The 60 calendar day period for processing an application restarts when the additional information is received by the Medicare fee-for-service contractor or carrier.

5. The applicant ASC will provide evidence of its completeness notification from the Medicare fee- for-service contractor or carrier to the accreditation organization (AO). Per CMS requirement, AAAHC may not schedule a survey without evidence of this completeness or readiness notification.

6. AAAHC surveys the ASC to determine compliance with AAAHC Standards and the Medicare Conditions for Coverage (CfC). AAAHC sends the written survey results to both the ASC and the RO.

7. The RO reviews the survey results and all other relevant information. If the applicant is in compliance with all federal requirements, the RO will issue a provider agreement and assign a CMS certification number (CCN).

8. If an applicant is not in compliance with any of the federal requirements, the RO will issue a letter explaining that the enrollment process cannot proceed until the applicant comes into compliance. If an applicant is determined as not in compliance, they may be required to undergo another full survey to determine compliance.

Note: The Regional Office of CMS is the authority for approval of an ASC to participate in the Medicare certification program. If your ASC has ever been denied Medicare certification or terminated (voluntarily or involuntarily) from participation in the Medicare program, the ASC must obtain approval through written consent from a CMS RO to undergo an AAAHC Medicare Deemed Status Survey.



Medicare Certification Process 855B Enrollment Process

The ASC must obtain its National Provider Identification (NPI) number prior to submitting its 855B to CMS. It takes approximately ten days to receive the NPI number. Use https://nppes.cms.hhs.gov or call 1.800.465.3203 for

instructions and forms for obtaining NPI numbers.

The ASC completes the CMS 855B enrollment application form. Access the form at: https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads/cms855b.pdf

or through CMS’s Internet-based PECOS: https://pecos.cms.hhs.gov/pecos/login.do

The ASC submits appeal to RO within 60 calendar days from date of denial letter.

ASC chooses not to appeal within 60 calendar days. No further action necessary.

If the ASC is in compliance with all of the CfC, the RO (not AAAHC) will issue an agreement, assign a CCN, and determine effective date of certification (not always the survey date).

If the ASC is not in compliance with the CfC, the RO will notify the ASC that the enrollment process cannot proceed until the ASC is in compliance with the Medicare

Medicare fee-for- service contractor recommends approval and provides RO and ASC written notice of completion of 855B.

The ASC submits second appeal to RO within 60 calendar days from date of denial letter. The ASC must apply for another initial MDS

survey to determine compliance with CfC.

Medicare fee-for- service contractor determines ASC does not meet requirements. Medicare fee-for- ser- vice contractor notifies RO. The RO mails second denial letter.

Appeal forwarded to Medicare fee-for-service contractor for recommendation of approval or denial.

AAAHC cannot conduct a deemed status survey.

Medicare fee-for-service contractor forwards recommendation for denial of enrollment to the RO. The RO issues denial letter to the ASC.

Medicare fee-for-service contractor verifies the information on the 855B application.

If second appeal is denied, AAAHC may conduct accreditation survey only.

AAAHC reports survey results to ASC and sends copy to RO.

AAAHC surveys ASC to determine if it is compliant with Medicare Conditions for Coverage (CfC). If non-compliant with 1 or more conditions, AAAHC can neither recommend deemed status nor grant AAAHC accreditation.

ASC must provide evidence of Medicare fee-for- service contractor notice of application completion to AAAHC before a survey can be scheduled.

ASC may submit an Application for Survey to AAAHC requesting a Medicare Deemed Status Survey.

Medicare fee-for-service contractor provides SA, RO, and ASC confirmation of application completion within 60 calendar days of receipt of 855B.

Within ten days of receiving a completed application, the Medicare fee-for-service carrier will send a copy to the SA and RO.



Understanding, Planning, and Preparing for a Medicare Deemed Status Survey with AAAHC Before requesting a survey for Medicare Deemed Status (see Survey Types, page 5), an organization must have a National Provider Identification (NPI) number and have applied for and received recommendation for approval of the organization’s CMS 855B enrollment. See pages 287 for a description of the enrollment process and contact resources.

Preparing for Your Survey

1. Confirm that your ASC meets the AAAHC eligibility criteria (see page 3).

2. Identify the type of survey you are seeking (see page 5).

3. Review the Policies and Procedures.

4. Complete a self-assessment of your organization’s compliance with the all Medicare CfC and all AAAHC Standards detailed in the applicable chapters of this handbook. Some individual AAAHC Standards may not apply depending on the services provided. Notes and resources: • Use the most current version of the Accreditation Handbook for Medicare Deemed Status Surveys. Current

AAAHC Standards integrate CMS Conditions for Coverage. To receive a recommendation for Medicare deemed status from AAAHC, an organization must also demonstrate compliance with all elements of the NFPA 101® Life Safety Code® (LSC), 2012 Edition. The Physical Environment Checklist (PEC) (included in this handbook) is based on these requirements. At the time of publication of these Standards, no other LSC edition is recognized by CMS.

• Consider attending Achieving Accreditation. Dates and additional information about upcoming conferences are posted at: https://www.aaahc.org/education/seminar-achieving-accreditation/

• CMS Interpretive Guidelines can be referenced at: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/GuidanceforLawsAndRegulations/ASCs

5. For any issues you identify (missing documentation, flawed processes), create and implement a prioritized action plan to bring your organization into compliance. Identify the time required to achieve compliance with each item. Place deadlines for deliverables on a timeline.

6. Complete and submit the AAAHC Application for Survey and supporting documents. • Consider the expiration date of your current term of accreditation (if applicable) and the time needed to complete

your action plan (step 5) when submitting your application. An application is valid for six months from the date it is received at the AAAHC office. Allow 30 days for AAAHC internal review of your documents.

7. During a Medicare Deemed Status Survey, a procedure or surgery must be observed. Identify dates on which procedures or surgeries are performed and dates when physicians, key leaders, and/or administrators will be available. A Survey Scheduler will contact you for this information.

8. You will receive a survey information packet with an invoice for the survey and information about what to expect during the unannounced onsite visit.

9. Post the Notice of Accreditation Survey (see page 9) prominently throughout your organization as early as possible. The notice must remain posted for a minimum of 30 days or through the end of the survey, whichever occurs later.

After Your Survey

Your survey team will submit its written findings to AAAHC Accreditation Services within four business days.

For surveys in which no Medicare deficiencies are cited

Survey results are presented to the AAAHC Accreditation Committee. The Committee reviews the surveyor ratings, comments, and your ASC’s previously submitted documents in making decisions regarding AAAHC accreditation, and a recommendation to CMS for Medicare Deemed Status. You will receive a decision letter with the term of accreditation and the recommendation to CMS, and a comprehensive survey report.

For surveys in which Medicare deficiencies are identified

AAAHC prepares a letter of deficiency for your ASC within 10 business days. Your organization must create and submit a Plan of Correction (PoC) to AAAHC within 10 calendar days of receiving the letter. Based on the type of survey and the level of Medicare deficiency (see page 11), AAAHC may still recommend Medicare Deemed Status.



1095 Learn Portfolio: Education Resources for Accelerated Readiness

The 1095 Strong Philosophy The 1095 Strong, quality every day philosophy is a call-to-action spearheaded by AAAHC to equip ambulatory leaders with the best of what they need to operationalize quality practices. Our commitment to this philosophy is demonstrated through the provision of ongoing client engagement and education throughout the three-year accreditation term. 1095 Strong emphasizes the importance of quality practices and readiness throughout the 1,095 days of the accreditation term.

1095 Learn Portfolio The 1095 Learn portfolio is central to learning and development and supports the AAAHC effort to continue advancing the standard of care by more frequent client engagement throughout the accreditation term with tools, resources, and education. Live Seminars Achieving Accreditation is an immersive, live education program designed to help you strengthen your tools, assemble your resources, and get more from accreditation. On Demand 1095 Learn, the AAAHC education portal, delivers interactive and engaging education to refresh an organization’s knowledge and optimize their quality practices at a personalized pace. AAAHC offers a variety of live and self-paced webinars and eLearning modules that assist organizations in their journey to provide quality patient care every day. Visit aaahc.org/learn to review our current education opportunities. Quality Improvement Resources For over 40 years, AAAHC has been driving quality improvement in ambulatory patient care by identifying trends and improving AAAHC Standards compliance via meaningful performance measurement, evidence-based tools, and focused educational opportunities. Visit aaahc.org/quality to learn about AAAHC benchmarking studies, review our line of toolkits, and download a pdf copy of the Quality Roadmap.

http://www.aaahc.org/learn

http://www.aaahc.org/quality



Toolkit Resources Crosswalk AAAHC Resource AAAHC Tool AAAHC Standards Chapter

Toolkit

Care Coordination Allergy Documentation

Ch 4: Quality of Care Provided Ch 6: Clinical Records and Health Information

Credentialing and Privileging Ch 2: Governance

Medication Reconciliation Ch 4: Quality of Care Provided Ch 6: Clinical Records and Health Information Ch 10: Surgical and Related Services Ch 11: Pharmaceutical Services

Safe Injection Practices Ch 7: Infection Prevention and Control and Safety Ch 11: Pharmaceutical Services

Falls Prevention Endoscope Reprocessing

Ch 7: Infection Prevention and Control and Safety

Emergency Drills Ch 8: Facilities and Environment

Pre-op Evaluation

Ch 9: Anesthesia Care Services Ch 10: Surgical and Related Services

Pain Management

Ambulatory Surgery and Obesity in Adults

VTE

Peer Review and Benchmarking Ch 2: Governance Ch 5: Quality Management and Improvement



Glossary Terms are defined for the purpose of facilitating interpretation of AAAHC Standards.

ADA Americans with Disabilities Act

Administrative controls The use of administrative measures (i.e., policies, procedures, training, warning labels, and enforcement measures) to reduce risk.

Advance directives A formal document or a set of documents that details a person’s wishes about care before they become temporarily or permanently incapacitated. All 50 states and the District of Columbia have adopted laws to legalize the use of living wills, health care proxies, and/or a durable power of attorney.

Alcohol-based hand rub (ABHR)

An alcohol-containing preparation designed for application to the hands to reduce the number of viable microorganisms on the hands when no visible soil is present. In the United States, such preparations usually contain 60%-95% ethanol or isopropanol.

Allergies Abnormal reactions of the immune system that occur in response to allergens. An allergic reaction may occur on contact with an otherwise harmless substance or subsequent to medication administration.

Allied health professionals Includes, but is not limited to, advance practice registered nurses and physician assistants. Accredited organizations may wish to include additional categories of health care professionals e.g., dental assistants and orthopedics technicians, who are employed by a credentialed dentist or physician and assist in surgical procedures.

Alternate power source An additional power source that maintains function when the primary power source fails.

Antimicrobial soap A soap (i.e., detergent) containing an antiseptic agent.

Antiseptic A germicide used on skin or living tissue for the purpose of inhibiting or destroying microorganisms. Examples include alcohols, chlorhexidine, chlorine, hexachlorophene, iodine, chloroxylenol (PCMX), quaternary ammonium compounds, and triclosan.

Antiseptic hand rub The process of applying an alcohol-based antiseptic hand rub product to all surfaces of the hands to reduce the number of microorganisms present.

Antiseptic hand wash Washing hands with water and soap or detergents containing an antiseptic agent.

APRN (also APN) Advanced practice registered nurse; includes clinical nurse specialist, nurse midwife, nurse practitioner, and nurse anesthetist. Educational and certification requirements and the legal scopes of practices are determined at the state level and vary considerably. Physician assistant (PA) is not included in the definition of APRN (see Physician assistant).

ASA American Society of Anesthesiologists. This professional organization has well- recognized anesthesia, analgesia, and sedation-related standards and guidelines.

Asepsis The state of being free of living pathogenic microorganisms; also the process of removing pathogenic microorganisms and protecting against infection by such organisms.

Audit An examination of records (clinical, financial, personnel, etc.) to verify contents and/or check accuracy. When the result of an audit reveals missing or inaccurate information, appropriate quality improvement activities should be undertaken to ensure that improvement occurs.

Benchmark A reference point against which other, similar things can be evaluated or measured.



Glossary

Benchmarking A systematic comparison of similar products, services, or work processes to identify the best practices known to date for the purpose of continuous quality improvement. When the results of benchmarking indicate that performance improvement is needed, appropriate quality improvement activities should be undertaken to ensure that improvement occurs. Recognized and reliable sources of benchmarking data may be available from professional organizations and societies, and from agencies such as the CDC and AHRQ. Refer to the Resources section of this Handbook for other suggested sources.

Benchmarking, external The comparison of the performance of one organization with another’s similar processes outside the organization, or with a group of organizations that have the similar process.

Benchmarking, internal The comparison of performance within an organization, such as by physician or department, or over time.

Bioburden The degree of microbial contamination. The microbiological load (i.e., number of viable organisms in or on the object or surface) or organic material on a surface or object prior to decontamination or sterilization. Also known as “bioload” or “microbial load.”

Biological indicator A device to monitor the sterilization process by monitoring a standardized population of bacterial spores known to be resistant to the mode of sterilization. Biological indicators do not indicate an item is sterile. Use of a biological indicator indicates that all the parameters necessary for sterilization were present.

Bloodborne pathogens Disease-producing microorganisms spread by contact with blood, or other body fluids contaminated with blood.

Bloodborne Pathogen Standard*

A standard developed, promulgated, and enforced by the Occupational Safety and Health Administration (OSHA) directing employers to protect employees from occupational exposure to blood and other potentially infectious material.

Chemical indicator A device or product to monitor the sterilization process that changes color or form with exposure to one or more of the physical conditions within the sterilizing chamber (e.g., temperature, steam). Chemical indicators are intended to detect potential sterilization failures that could result from incorrect packaging, incorrect loading of the sterilizer, or malfunctions of the sterilizer. A “pass” response does not verify that the processed items are sterile.

Chemical sterilant Chemicals used for the purpose of destroying all forms of microbial life, including bacterial spores.

Cleaning The removal of visible soil and organic and inorganic contamination from a device or surface, using either the physical action of scrubbing with a surfactant or detergent and water, or an energy-based process (e.g., ultrasonic cleaners) with appropriate chemical agents.

CLIA Clinical Laboratory Improvement Amendments (CLIA) — All laboratories must possess a CLIA waiver, or a CLIA Certificate to perform testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

Clinical support staff Clinical support staff works under the direct supervision or order of a licensed health care professional. Clinical support staff provides vital assistance in treating and caring for patients or performing diagnostic tests. In some cases, they are involved in looking after the general well-being and comfort of patients. These roles have a direct impact on patients’ lives. The professionals may be licensed or certified. Examples: Registered nurses (RN), licensed practical nurses (LPN), licensed vocational nurses (LVN), certified nurse assistants (CNA), medical assistants, dental assistants, pharmacy technician, ultrasound technicians, radiation therapists, surgical technicians. An organization determines whether a registered nurse is considered an allied health care professional or clinical support staff.

Communicable disease A disease the causative agents of which may pass or be carried from one person to another directly or indirectly.



Glossary

Control biological indicator A biological indicator from the same lot as a test indicator that is left unexposed to the sterilization cycle and then incubated to verify the viability of the test indicator. The control indicator should yield positive results for bacterial growth.

Credentialing A process through which an organization reviews and validates the professional qualifications of applicants (i.e., physicians, allied health professionals) requesting clinical privileges.

Credentials Evidence of qualifications (e.g., licenses, certifications, education, and experience).

Credentials Verification Organization (CVO)

A service company providing primary source verification of practitioners’ credentials on behalf of an accredited organization.

CRNA Certified registered nurse anesthetist

Decontamination A process or treatment that renders a medical device, instrument, or environmental surface safe to handle. According to OSHA, “the use of physical or chemical means to remove, inactivate, or destroy bloodborne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal” [29 CFR 1910.1030].

Discharge, medical Medical discharge may occur when a patient is determined to be medically stable but not yet ready to physically leave (i.e. physical discharge) from a health care facility. Before medical discharge, a patient must be medically evaluated by the appropriate professional.

Discharge, physical The actual physical departure of a patient from a health care facility.

Disinfectant A chemical agent used on inanimate objects (nonliving objects such as floors or sinks) to destroy virtually all recognized pathogenic microorganisms, but not necessarily all microbial forms (e.g., bacterial endospores). The Environmental Protection Agency (EPA) groups disinfectants according to whether the product label claims to be a “limited,” “general” or “hospital” disinfectant. Always follow manufacturer’s instructions and recommendations for use of a product.

Disinfection The destruction of pathogenic and other kinds of microorganisms by physical or chemical means. Disinfection is less lethal than sterilization, because it destroys most recognized pathogenic microorganisms, but not necessarily all microbial forms, such as bacterial spores. Disinfection does not ensure the margin of safety associated with sterilization processes. Also see high-level disinfection, intermediate disinfection, and low-level disinfection.

Engineering controls Controls (e.g., sharps disposal containers, self-sheathing needles, and medical devices such as sharps with engineered injury protections and needleless systems) that isolate or remove the bloodborne pathogens hazard from the workplace.

Exposure time A period of time during a sterilization or disinfection process in which items are exposed to the sterilant or disinfectant at the parameters specified by the manufacturer (e.g., time, concentration, temperature, pressure). Always follow manufacturer’s instructions and recommendations.

Food and Drug Administration (FDA)

An agency within the U.S. Department of Health and Human Services that Administration (FDA) is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and by helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.



Glossary

Germicide An agent that destroys microorganisms, especially pathogenic organisms. Other terms with the suffix “–cide” (e.g., virucide, fungicide, bactericide, tuberculocide, sporicide) indicate an agent that destroys the microorganism identified by the prefix. Germicides may be used to inactivate microorganisms in or on living tissue (antiseptic) or on environmental surfaces (disinfectants). Always follow manufacturer’s instructions and recommendations for use.

Hand hygiene A general term that applies to hand washing, antiseptic hand wash, antiseptic hand rub, and surgical hand antisepsis.

Health care-acquired infection (HAI)

Any infection associated with a medical or surgical intervention. The term infection (HAI) “health care-acquired” replaces the outdated term “nosocomial.”

Health care professional An individual who provides health services to a patient.

High-level disinfection (HLD) A disinfection process that inactivates vegetative bacteria, mycobacteria, fungi, and viruses, but not necessarily high numbers of bacterial spores. The FDA further defines a high-level disinfectant as a sterilant used under the same contact conditions except for a shorter contact time.

Hospital grade disinfectant A germicide that is registered by EPA for use on inanimate objects in hospitals, clinics, dental offices, or any other medical-related facility. Efficacy is demonstrated against Salmonella choleraesuis, Staphylococcus aureus, and Pseudomonas aeruginosa.

Immunization The process by which a person becomes immune or protected against a disease. Although not identical in meaning, this term is often used interchangeably with “vaccination” or “inoculation.”

Implant, or implantable device

Device placed into a surgically or naturally formed cavity of the human body Implantable device and intended to remain there for more than 30 days.

Injection safety A set of measures taken to perform injections in an optimally safe manner for patients, health care personnel, and others.

Intermediate-level disinfectant

A liquid chemical germicide registered by the EPA as a hospital disinfectant and with a label claim of potency as a tuberculocidal.

Intermediate-level disinfection

A disinfection process that inactivates vegetative bacteria, most fungi, mycobacteria, and most viruses (particularly the enveloped viruses), but not bacterial spores.

Low-level disinfectant A liquid chemical germicide registered by the EPA as a hospital disinfectant. OSHA requires low-level disinfectants also to have a label claim for potency against HIV and HBV if used for disinfecting clinical contact surfaces.

Low-level disinfection A process that will inactivate most vegetative bacteria, some fungi, and some viruses, but cannot be relied on to inactivate resistant microorganisms such as mycobacteria or bacterial spores.

Malignant hyperthermia (MH)

A biochemical chain reaction response triggered by commonly used general anesthetic gases and the paralyzing agent succinylcholine within the skeletal muscles of susceptible individuals. The general signs of the MH crisis include tachycardia (a rise in heart rate), a greatly increased body metabolism, muscle rigidity and/or fever that may exceed 110° F. Severe complications include: cardiac arrest, brain damage, internal bleeding, failure of other body systems, and death.

Mechanical indicator A device (e.g., gauge, meter, display, printout) that displays an element of the sterilization process (e.g., time, temperature, pressure).

Medical staff Includes all credentialed and privileged health care professionals.

NIOSH The National Institute for Occupational Safety and Health is the federal agency responsible for conducting research and making recommendations for the prevention of work-related disease and injury. The Institute is part of the Centers for Disease Control and Prevention.



Glossary

Occupational exposure A reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employee’s duties.

Operating room A room equipped for performing surgery; typically maintained as a sterile environment.

OPIM Other Potentially Infectious Materials. An OSHA term that refers to (1) The following human body fluids: semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids; (2) Any unfixed tissue or organ (other than intact skin) from a human (living or dead); and (3) HIV-containing cell or tissue cultures, organ cultures, and HIV (human immunodeficiency virus)-containing or HBV (hepatitis B virus)-containing culture medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV.

Other qualified licensed individuals

Those licensed practitioners who are authorized in accordance with their state scope of practice laws or regulations, such as advanced practice registered nurses, registered nurses, physical therapists, and social workers.

Peer evaluation Formal documentation received during the initial application for staff privileges. Peer evaluations may come from other professionals acquainted with the applicant’s performance, training program mentors, or past professional associates.

Peer review A participatory process that monitors important aspects of care provided by an organization’s individual practitioners, as well as by the organization’s practitioners in the aggregate. The results of peer review at the individual level are used in the medical staff reappointment process. When the results of peer review indicate a need for performance improvement at the individual and/or aggregate levels, appropriate quality improvement activities should be undertaken to ensure that improvement occurs.

Peer review vs. performance review

Members of the medical staff participate in establishing peer review criteria performance review and undergo peer review as described in Chapter 2.III, and in accordance with the organization’s peer review policies and procedures. In addition to other organizationally-defined allied healthcare professionals, advance practice registered nurses, physician assistants, and anesthesiologist assistants undergo peer review. Other allied healthcare professionals undergo performance review according to the organization’s policy and at least annually.

Performance goal A statement of a desired level of performance, expressed quantitatively (numerically, e.g., “zero patient falls” or “zero medication errors” or as a percentage, e.g., “greater than 95% compliance”). A performance goal is set when a QI study is begun, so that after corrective action has been taken and re-measurement of performance has occurred, the organization may compare its new performance level against its stated goal and determine whether the corrective actions have enabled the organization to reach the performance goal. Whenever possible, performance goals should be based on established benchmarks of best practice performance.

Performance measure A clearly defined statement or question describing information to be collected for purposes of improving processes and outcomes of care. Two examples are: (1) Percentage of cases in which each cataract surgeon in the ASC starts (makes the incision for) cataract surgery on or before the time the procedure is scheduled to start. (2) Percentage of visits for which each provider documents a recommendation for chlamydia screening for sexually active non-pregnant female patients age 24 years and younger who have a scheduled (not drop-in) visit.

Personal protective equipment (PPE)

Personal protective equipment is specialized clothing or equipment (e.g., equipment (PPE) gloves, masks, protective eyewear, gowns) worn by an individual for protection against a hazard. General work clothes (e.g., uniforms, pants, shirts, or blouses) not intended to function as protection against a hazard are not considered to be personal protective equipment.



Glossary

Physician A person who has been educated, trained, and licensed to practice the art and science of medicine. The term “physician” includes professionals who have earned MD, DO, DDS, DMD, or DPM degrees.

Physician assistant (PA) A physician assistant is a licensed health professional who practices medicine as a member of a team with his/her supervising physician.

Plain or non-antimicrobial soap

Soaps or detergents that do not contain antimicrobial agents or contain very low concentrations of such agents; these agents are effective solely as product preservative.

Post-exposure evaluation The evaluation and appropriate treatment of a health care worker following an occupational exposure to suspected or confirmed bloodborne pathogens.

Primary source verification Documented verification by an entity that issued a credential indicating that an individual’s statement of possession of that credential is true. Verification may be provided by mail, fax, telephone, or electronically, provided that the method by which it is obtained is documented and measures are taken to demonstrate that there was no interference in the communication by an outside party.

Privileging An organization’s formal process for the assessment of an applicant’s qualifications in a specific area or aspect of patient care. An organization’s formal privileging process uses appropriate criteria. Approval, modification, or denial of an applicant using appropriate criteria and approving, modifying, or denying any or all of the requested privileges in a non-arbitrary manner. See pages 46-48.

Procedure/treatment room A room, as designated by the organization, in which various treatments or procedures are performed.

Quality assurance (QA) Systematic monitoring and evaluation of the various aspects of a project, service, or facility to maximize the probability that minimum standards of quality are being attained. This term is older and not as likely to be used today within health care, because of its focus on minimum standards of quality. The term “quality improvement” is more reflective of ongoing, measurable, and sustained improvements to the care and safety of patients. Throughout its Standards and processes, AAAHC uses the terms “quality improvement” and “QI.”

Quality improvement (QI) program

A systematic, ongoing process to achieve and sustain measurable improvements in performance. A QI program includes various activities to measure and improve performance. Examples of measurement activities include (but are not limited to) benchmarking, monitoring, auditing, and QI studies. Performance improvement activities include corrective actions taken or other types of interventions implemented to improve performance. The AAAHC Standards require an accredited organization to have a written QI program approved by its governing body.

Quality improvement (QI) study

A type of QI activity that includes corrective actions and/or other interventions to improve performance, and demonstrates through measurement that performance improvement has occurred and is sustained.

Quality monitoring The ongoing collection of data about a specific aspect of performance. The data is usually collected for a defined interval of time, and then compared to the same data collected for previous intervals in order to identify desirable and undesirable changes. When undesirable changes are identified, appropriate quality improvement activities should be undertaken to ensure that improvement occurs. Examples of aspects of performance that an organization might monitor include: complications, infections, patient falls, adverse incidents, building safety issues such as exit lighting and fire equipment, review of medical record documentation, on-time starts, no-shows, near misses, patient satisfaction, and access to care.

Reappointment Renewal of membership in a health care service, such as a medical staff or medical group.

Recredentialing A process through which an organization periodically reviews and validates the professional qualifications of providers (i.e., physicians, allied health professionals) requesting reappointment of clinical privileges.



Glossary

Registered nurse (RN) A nurse who has graduated from a program at a college or university and has successfully passed a national licensing exam. Accredited organizations determine whether a registered nurse is considered an allied health care professional or clinical support staff.

Regulated waste Liquid or semi-liquid blood or other potentially infectious materials; contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed; items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling; contaminated sharps; and pathological and micro-biological wastes containing blood or other potentially infectious materials. Hazardous waste and pharmaceutical waste is not considered regulated waste.

Restricted area A designated space contained within the semi-restricted area and accessible only through a semi-restricted area. The restricted area includes the operating and other rooms in which operative or other invasive procedures are performed. Restricted areas have specific HVAC design requirements associated with the intended use of the space. Personnel in the restricted area should wear surgical attire and cover head and facial hair. Masks should be worn when the wearer is in the presence of open sterile supplies or of persons who are completing or have completed a surgical hand scrub. Only authorized personnel and patients accompanied by authorized personnel should be admitted to this area. (Source: AORN)

Secondary source verification

Documented verification of a credential through a verification report from an entity that has performed primary source verification of that credential. Information received from any such source must meet the same transmission and documentation requirements as defined under primary source verification.

Spaulding classification This classification system divides medical devices into categories based on the risk of infection involved with their use. It is widely accepted and used by the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), epidemiologists, microbiologists, and professional medical organizations to help determine the degree of disinfection or sterilization required for various medical equipment and patient care items.

Surgical Site Infection (SSI) An infection that occurs after surgery in the part of the body where the surgery took place.

Sterile Free from all living microorganisms; aseptic.

Sterilization The physical or chemical process that eliminates all microorganisms. This may be achieved by heat, chemicals, irradiation, high pressure and filtration, or a combination of these methods.

Surfactant A compound that lowers the surface tension (or interfacial tension) between two liquids or between a liquid and a solid. Surfactants may act as detergents, wetting agents, emulsifiers, foaming agents, and dispersants.

Surgical hand scrub An antiseptic-containing preparation that substantially reduces the number of microorganisms on intact skin; it is broad-spectrum, fast-acting, and exists or endures over a prolonged period.

Travel medicine A branch of medicine that specializes in diseases and conditions that are acquired during travel. Travelers to different countries should be aware of the potential for acquiring diseases and injuries that are not common in their own country. Immunizations, preventive medications, and general precautions are encouraged prior to trips to different parts of the world.

Universal precautions An approach to infection control that treats human blood and certain human body fluids as if they were known to be infectious for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and other bloodborne pathogens.

Vaccine A product that improves immunity to a specific disease.



Glossary

Work practice controls Practices incorporated into the everyday work routine that reduce the likelihood of exposure by altering the manner in which a task is performed (e.g., prohibiting recapping of needles using a two-handed technique).

Workers’ Compensation laws

Regulations regarding employer requirements when employees are injured or disabled on the job. These laws are regulated by each state.

Index Accreditation Handbook for Medicare Deemed Status, v41



Index Note: Page references followed by n, indicate footnotes.

A AATB. See American Association of Tissue Banks ABHR. See alcohol-based hand rub abuse governance and, 35 grievance procedure for, 32 patient rights and, 26 access/availability to alcohol-based hand rub, 92 to clinical records, 197 emergency planning and, 106 unauthorized, 70 to diagnostic images, 152 to drug information, 134 to emergency equipment, 104 to medical gas storage, 231 peer review and, 50 quality improvement program and, 62 radiation oncology services and, 166 accountability for clinical records management, 70 governing body and, 34–35 for privileging/credentialing, 40 accounts, administration of, 52 accreditation annual review of, 169 California regulations on, 19–21 certificate of, 15, 17 posting of, 15, 20–21 continuation of, 16–17 decision/notification of, 11, 14 denial/revocation of, 11, 15–16 end of, 17 process of after survey, 11–14 pre-survey, 3–9 during survey, 10–11 public recognition of, 15 representation of, 17, 39 term of, 15 Accreditation Association for Ambulatory Health

Care (AAAHC), Inc. accreditation by (See accreditation) Accreditation Services, 4 contact information, iii reporting changes/events to, 17, 38, 169 standards of, 2–3 ambulatory surgical centers, 207–278 applicable version of, 2 application of, 2 California and, 19–21 comments and suggestions, 2 and denial/revocation, 15 emergencies, management of, 203 governance of, 35 imaging services, 147–152

and Medicare CfCs, 283–285 not applicable to MDS Accreditation, 111 patient rights and responsibilities, 25–32 quality improvement program, 61 radiation oncology treatment services, 163–

167 rating methodology, revised, 286 revisions v41, i, 281–282 risk management and, 66–68 and smoking ban, 277 teaching/publishing, 153–154 and toolkit, 292 Accreditation Committee, AAAHC, 11 Achieving Accreditation, 290–291 ACLS. See advanced cardiac life support ADA. See Americans with Disabilities Act adenosine, for resuscitation, 204 administration, 51–55 documentation requirements for, 51, 170 governance of, 34, 39 quality management and improvement and, 61 administrative controls, definition of, 293 administrators, responsibilities and functions of,

39 admitting privileges, 60 overnight care/services and, 159 advanced cardiac life support (ACLS) anesthesia care services and, 110 California regulations on, 21 personnel records and, 202 advance directives, 31 in clinical record, 197 definition of, 293 patient rights and, 27 advanced practice registered nurse (APRN),

definition of, 293 advanced trauma life support (ATLS), personnel

records and, 202 adverse action report, privileging/credentialing

and, 42, 194 adverse incident(s) definition of, 68 quality improvement program and, 61, 64 risk management and, 67 adverse incident reporting administration of, 52 California regulations on, 20 orientation and training on, 53 personnel records and, 201 adverse reactions, to drugs or materials, 68, 72,

115, 134, 199 advertising, governance of, 38 advice/advice given clinical records and, 74, 198 See also after-hours care/advice;

referrals/consultations



Index

AED. See automated external defibrillator aftercoolers, 235, 244 after-hours care/advice clinical records and, 74, 198 governance of, 37 patient information on, 29 responsibility for coverage, 66 AHA. See American Heart Association AHJ. See authorities having jurisdiction airborne infection isolation rooms, electrical

system and, 255–256 air conditioning. See HVAC system air pressure control, and surgical/related services,

120 airway management, anesthesia care services

and, 103 alarms for electrical system, 249, 251 fire alarm system, 260–263, 273 functions controlled by, 260 for medical air systems, 236 for medical gas systems, 233, 241–242, 245–

246 power supply and, 254, 256 for sprinkler systems, 210 for vacuum systems, 237, 241–242, 245–246 for waste anesthetic gas disposal, 238 alcohol-based hand rub (ABHR), 120 definition of, 293 dispensers access to, 92 operation of, 228 requirements for, 220, 228 alcohol use, privileging/credentialing and, 188 allergies/sensitivities in clinical record, 72, 198–199 definition of, 293 patient responsibilities and, 28 all-hazards approach, and emergency

preparedness program, 105, 110 allied health care professional definition of, 293 privileging/credentialing and, 47 and renal lithotripsy services, 129 Ambulatory Health Care Occupancies, 91 ambulatory surgical center (ASC) CFCs for, 2–3 definition of, 3, 33, 157, 205 with Medicare Deemed Status, 1–2 and patient rights and responsibilities, 25–32 standards for, 207–278 See also organization, accreditable ambulatory surgical center (ASC) services,

definition of, 3 American Arbitration Association (Chicago), 16 American Association of Tissue Banks (AATB),

118 American Heart Association (AHA), 110, 112 American National Standards Institute (ANSI), 219,

223, 260, 265, 275 Safe Use of Lasers, 126 American Registry of Radiologic Technologists

(ARRT), 164

American Society of Anesthesiologists (ASA), 293 American Society of Mechanical Engineers

(ASME), 275 amiodarone, for resuscitation, 204 ammeter, 249 analgesics, 111 anesthesia general definition of, 103 emergency management and, 203 standards on, 108–112 local/topical definition of, 103 emergency management and, 203 standards on, 104–107 regional definition of, 103 emergency management and, 203 standards on, 108–112 anesthesia assistants, 104, 106n–107n, 111, 124n anesthesia care services, 103–112 alarms for, 242 California regulations on, 19 in clinical record, 71, 197, 199 definition of, 103, 105n documentation requirements for, 108, 110, 112,

171–172, 199 pediatric, 112 and renal lithotripsy services, 130, 130n surgical/related services and, 117 anesthesiologist, 104, 111 anesthetists, responsibiltiies of, 105–107 annunciator, 251 for fire alarm system, 260 ANSI. See American National Standards Institute antibiotics, and surgical/related services, 123 antidote, 137 antimicrobial soap, definition of, 293 antiseptic, definition of, 293 anti-trust, governance of, 35 anxiolysis, definition of, 103 appeals of decisions, accreditation and, 11, 14–16,

22–23 appliances, 224 Application for Survey, AAAHC, 7–8, 16 and limitations on other rights, 16 obtaining, 7–8 rejection of, 4, 8 and responsibilities, 9 time period for, 8 appointment/reappointment criteria, application of, 40 governance of, 39, 169 privileging/credentialing and, 40, 42, 44–45, 47 process for, 41, 47 timeframe of, 44 appointments, patient, clinical records and, 74,

198 appraisal. See evaluation/appraisal APRN. See advanced practice registered nurse arbitration, accreditation and, 16 Area Alarm system, 242 areas of refuge, requirements for, 219



Index

ARRT. See American Registry of Radiologic Technologists

articles of incorporation/organization, 34 ASA. See American Society of Anesthesiologists asepsis/aseptic technique, 120 definition of, 293 ASME. See American Society of Mechanical

Engineers aspirin, for resuscitation, 204 assessment anesthesia care services and, 107, 199 of patient satisfaction, 70 privileging/credentialing and, 40 surgical/related services and, 115, 124 assets of organization, administration of, 52 ASTM International, 265, 278 atriums, 219, 225 atropine, for resuscitation, 204 attestation, privileging/credentialing and, 42, 189 attire patient, removal of, 120 and surgical/related services, 119–120 attorneys, inquiries from, governance of, 38 audit of critical processes, 62–63 definition of, 293 authentication clinical records and, 72 and imaging services, 151 authorities having jurisdiction (AHJ), emergency

planning for, 107 automated external defibrillator (AED), 204 and anesthesia care services, 106, 110 availability. See access/availability

B BAA. See Business Associate Agreement background check results, personnel records

and, 201 bags, resuscitator, 106, 204 basement, definition of, 207 basic life support (BLS), 82, 203 personnel records and, 202 batteries, 248–249, 258 and alternate power, 250–251 charger, 256 and emergency lighting, 221 benchmarks/benchmarking definition of, 293–294 internal/external, definitions of, 294 peer review and, 49 quality improvement and, 63, 65, 176 best practices, quality improvement program and,

65 bioburden, definition of, 294 biological indicator control, definition of, 295 definition of, 294 in sterilization, 77 biological products definition of, 58n

handling of, quality of care provided and, 58 biologicals allergies to, 115 in clinical record, 199 clinical trials of, 155n provision of, 134 biologic hazards personnel protection from, 86 See also under hazard bioterrorism, 86 blood/blood products administration of, 135 recall/damage/expiration of, 82 and surgical/related services, 117–118 bloodborne pathogens, 87 definition of, 294 orientation and training on, 153 personnel records and, 201 Bloodborne Pathogen Standard (OSHA), definition

of, 294 blood pressure monitoring, 108 BLS. See basic life support board certification, 45 Board of Directors, AAAHC appeal and, 23 privileging and, 190 brachytherapy, and radiation oncology services,

166 High/Low Dose Rate, 167 buildings codes, 89 high-rise, 272 services, 273–274 shell, checklist for, 208–209 bulletin boards, 259 burns, prevention of, 91 Business Associate Agreement (BAA), 8 bylaws of organization administration and, 51 credentialing and, 40 governance of, 34–35

C CABO. See Council of American Building Officials calcium chloride/gluconate, for resuscitation, 204 calibration of equipment facilities/environment and, 103 imaging services and, 149 pathology/laboratory services and, 144, 144n,

146n renal lithotripsy services and, 131 California accreditation regulations, 19–21 call systems, electrical system and, 254 carbon monoxide, 236 cardiac catheterization, 113 cardiac equipment, personnel trained with, 82 cardiac stents, MRI warnings and, 152 cardiopulmonary resuscitation (CPR), drills on,

104



Index

cash payments administration of, 52 See also payment policies CCN. See CMS Certification Numbers CDC. See Centers for Disease Control and

Prevention ceiling finishes, checklist for, 259 cells, human, handling of, 118 Centers for Disease Control and Prevention

(CDC), 76, 82 Centers for Medicare & Medicaid Services (CMS),

i, 1 agreement with ASC, 33 certification process, 287–289 emergencies, management of, 203 governance of contracts/arrangements with, 37 Interpretive Guidelines for CfCs, 1–2, 290 Regional Office, 287–288 and survey information, 8 webpage, 2–3 Certificate of Accreditation, AAAHC, 15, 17 California regulations on, 20–21 posting of, 15, 20–21 Certificate of Waiver, CLIA, 142, 142n, 143 certification and administration, 51 and fire safety, 262 and pathology/laboratory services, 141–142,

142n, 143, 143n personnel records and, 201 privileging/credentialing and, 40, 45, 47, 183,

186 certified registered nurse anesthetist (CRNA), 104,

104n, 106n, 111n change/changes, and appeal, 23 Change Notification Form, AAAHC, 17 chemical dependency. See substance abuse chemical exposure, 86–87 environment checklist and, 224 prevention of, 80 See also under hazard chemical indicator/sterilant, definition of, 294 chutes, 226 circuit breakers, 247, 258 circulation, blood, and anesthesia care services,

108 claims history, privileging/credentialing and, 42 cleaning definition of, 294 of facilities, 90, 90n of patient care areas, 79 and pharmaceutical services, 139 processes for, 77 cleaning products/solutions exposure to, prevention of, 80 guidelines for, 79 CLIA. See Clinical Laboratory Amendments clinical activities/capabilities. See scope of

services/practice clinical care, review of, 49

Clinical Laboratory Amendments (CLIA), 141, 143, 143n, 146, 294

Certificate of Waiver, 142, 142n, 143 and proficiency testing, 145 clinical operations. See operations of organization clinical records, 69–74 alternate locations for, 74n anesthesia care services and, 107 consistency of, 72 documentation requirements for, 170 individual, 71 legibility of, 70–71, 197 maintenance of, 148 organization of, 70 overnight care/services and, 160 pathology/laboratory services and, 144 person in charge of, 53 protection of, 70 radiation oncology services and, 166–167 release of, 70 renal lithotripsy services and, 132, 132n research activities and, 156 retention of, 70 retirement of, 70 summary in, 74, 199 and surgical/related services, 116, 121–123 work-related injury/illness in, 88 worksheet on, 197–200 See also documentation; health information;

records/minutes clinical studies, 155–156, 155n clothing patient, removal of, 120 and surgical/related services, 119–120 CMS. See Centers for Medicare & Medicaid Services CMS Certification Numbers (CCN), 4, 287 CO2, exhaled/end-tidal, 108 coagulopathy, and renal lithotripsy services, 130 cochlear implants, 152 Code of Federal Regulations, 3 Electronic, 2 collaboration, emergency preparedness program

and, 105–106 collection agency, 52 comfort, physical environment and, 90 Commercial Arbitration Rules, 16 Committee on Allied Health Education and

Accreditation, 107n communicable disease definition of, 294 and overnight care/services, 159 prevention of, 75–76 communication/notification areas of refuge and, 219 electrical system and, 256 emergency planning and, 105–108, 110 fire alarm systems, 260–263 governance of, 38, 169 on hazards, 87 hospitals and, 60 overnight care/services and, 158 of patient rights and responsibilities, 25, 27 quality improvement and, 62, 64, 181



Index

of recalls, 82 risk management and, 67 transfer information on, 124 wall space for, limitations on, 259 community health status, and quality of care

provided, 57 comorbidities, 114 competence/competencies administration of, 51–52 infection prevention and control, 76, 80 personnel records and, 201 privileging/credentialing and, 41, 193 surgical/related services and, 124n complaints, 6 patient rights and, 27 privileging/credentialing and, 42, 188, 194 review of, policies on, 67 compliance elements of, i, 286 governance of, 35 means of assessment of, 11 with Omnibus Reconciliation Act, 18 as peer review criterion, 49n compressors/compressor systems, 230, 232–236,

244–245 electrical system and, 256 condensate trap, 235 condition-level deficiency, 11–12, 14 and denial/revocation, 15 Conditions for Coverage (CfCs), i, 1 and AAAHC Standards, 283–285 for ASCs, 2–3 emergencies, management of, 203 imaging services, 147 pathology/laboratory services, 141 patient rights and responsibilities, 25–32 physical environment, 206 conduct of organization, governance of, 35 conferences, appeals hearing, 22 confidentiality/privacy accreditation process and, 7–8 of clinical records information, 71, 71n emergency preparedness program and, 106 governance of, 35 orientation and training on, 53 overnight care/services and, 160 as patient right, 25 personnel records and, 201 physical environment and, 90 and work-related injury/illness, 88 conflict of interest, 11 surveyors and, 10 confused drug names, 135–136, 136n connectors, for vacuum systems, 237 conscious sedation, 103 consent, informed and anesthesia care services, 106, 106n in clinical record, 71, 73, 156, 197 and laser use, 128 and radiation oncology services, 165 and release of records, 70

and research activities, 156 and student/trainee involvement, 154 and surgical/related services, 116 and visitation, policies on, 66 consideration, as patient right, 25 construction of facilities checklist for, 208–211 safety and, 81, 91 consultations. See referrals/consultations Consultative Survey, 8 consumer advocate groups, inquiries from,

governance of, 38 continuing education governance of, 36 See also health education; professional

education continuity of care, 58 in clinical records, 74 emergency planning and, 107 continuity of operations, in emergency plan, 105 continuous improvement, 64 See also under quality improvement continuous intra-operative physiologic

monitoring, 108 contracting services/professionals governance of, 34, 36–37, 169 pharmaceutical services and, 135 renal lithotripsy services and, 131 control biological indicator, definition of, 295 controlled substances, 134 cooling, continuous, 110 cooperation, emergency preparedness program

and, 105–106 corrective actions emergency preparedness drills and, 104, 203 infection control and, 76 patient satisfaction and, 70 Plan of Correction (PoC) and, 279–280 quality improvement studies and, 177, 180–181 risk management program and, 68 smoke/fire protection and, 268 corridors with alcohol-based hand rub dispensers, 228 egress, 217–218, 220 separation of, 264 and smoke/fire protection, 267 cost of care quality improvement program and, 62n and quality of care provided, 57 See also fees Council of American Building Officials (CABO),

219, 223, 260 Council on Certification of Nurse Anesthetists,

106n Council on Recertification of Nurse Anesthetists,

106n covered ancillary services, 3 definition of, 4 covered surgical prodedures, 3 definition of, 4 CPR. See cardiopulmonary resuscitation



Index

crash cart, 204 credentialing, 40n currency of, 169 definition of, 40, 295 documentation requirements for, 41, 44–46, 169 governance of, 40–48 process for, 40–41, 43 quality of care provided and, 57 records worksheet on, 193–196 solo provider/practitioner and, 44n, 46, 195 teaching activities and, 153n credentials and anesthesia care services, 104 definition of, 295 and imaging services, 151 patient information on, 29 and quality of care provided, 57 and radiation oncology services, 163 Credentials Verification Organization (CVO), 43n definition of, 295 credit arrangements administration of, 52 See also payment policies credit cards, MRI warnings and, 152 criminal offense and accreditation, 15, 17 privileging/credentialing and, 42, 188, 194 critical care areas, electrical system and, 247–248,

254 CRNA. See certified registered nurse anesthetist cross-infection prevention of, 78–79, 120 See also infection cryogenic fluids, 230, 232–234, 242 crystalloids, 204 curtains, 278 custodial care, 157 CVO. See Credentials Verification Organization cylinders, medical gas, 229–234

D dampers, 265–266 dantrolene, 110 data backup, 70 data collection/analysis for peer review, 49 quality improvement program and, 62–65, 175 quality improvement studies and, 177, 179–181 data sources, quality improvement and, 63n data trending, peer review and, 49 date(s) of birth, in clinical record, 71, 197 of care in clinical record, 72 peer review and, 49n of electrical system testing, 247 of entry, in clinical record, 73, 198 date-sensitive information, 45, 169, 201 DEA. See Drug Enforcement Administration death of patient adverse incident and, 68 California regulations on, 20 decisions, 11, 14

patient rights and, 25, 31 decontamination definition of, 295 processes for, 77 decorations, 278 deep vein thrombosis (DVT), prevention of, 118,

118n defibrillators, 204 automated, 204 and anesthesia care services, 106, 110 internal, 152 deficiencies, 11–14 condition-level, 11–12, 14–15 standard-level, 12–14 delegated entity definition of, 44n privileging/credentialing and, 169 delegation emergency preparedness program and, 105 governance of, 35–37, 39, 44, 169 demolition of facilities, safety and, 81 dental services, governance of, 37 dental staff, and peer review, 48–50 dentist and anesthesia care services, 104–105, 109,

111 and imaging services, 151, 151n and peer review, 48–50 and quality improvement program, 62 and surgical/related services, 114, 116 development of organization, governance of, 35 devices, medical/mechanical cleaning of, 80, 84 clinical trials of, 155n patient instructions on, 85 pharmaceutical services and, 139 presurgical time-out and, 122 radiation oncology services and, 167 recall/damage/expiration of, 82 dew point, 236, 242 dextrose, for resuscitation, 204 diagnosis/diagnosis information in clinical record, 72, 197 patient education on, 59 patient rights and, 25 and quality of care provided, 58 radiation oncology services and, 166 renal lithotripsy services and, 130 diagnostic services, 147–152 in clinical record, 198 documentation requirements for, 173–174 standards of, 147–152 diagnostic studies/reports in clinical record, 72, 198–199 in health history, 115 dietary requirements, 160 diet supplements, patient responsibilities and, 28 dignity, as patient right, 25 diphenhydramine, for resuscitation, 204 directional indicators, 222–223 disabilities, persons with accommodations for, 90 governance and, 35



Index

disaster preparedness plan, 104–110, 203 drills on, 104 and fire safety, 276 governing body and, 34 and medical gas/vacuum systems, 246 orientation and training on, 53 personnel records and, 201 unified/integrated, 110 and vaccine handling, 140 discharge medical, definition of, 295 physical, definition of, 295 discharge criteria anesthesia care services and, 107, 109–110,

112 California regulations on, 21 and overnight care/services, 158 and surgical/related services, 115 discharge diagnosis, in clinical record, 72, 198 discharge instructions. See instructions given Discretionary Survey, AAAHC, 6–7 process after, 13 discrimination, patient rights and, 26 disease management guidelines, peer review and,

49n disease prevention programs, 75 See also infection prevention and control disinfectant definition of, 295 hospital grade, definition of, 296 intermediate-level, definition of, 296 low-level, definition of, 296 disinfection definition of, 295 high-level definition of, 296 processes for, 77 intermediate-level, definition of, 296 and laser use, 126 low-level, definition of, 296 dismissal from care, policies on, 66 disposal/disposal policy, for medications, 139 doctor. See dentist; health care professionals;

physician doctor of chiropractic (DC), 4 doctor of dental surgery/dental medicine

(DOS/DMD), 4 doctor of medicine/osteopathy (MD/DO), 4 doctor of optometry (OD), 4 doctor of podiatric medicine (DPM), 4 documentation AAAHC requirements for, 169–174 administration and, 51, 170 of advance directive, 31 and anesthesia care services, 108, 110, 112,

171–172, 199 of building code compliance, 89, 89n and chemical exposure, 87 and emergency preparedness program, 105–110 of equipment maintenance, 103 and fire alarm system, 260, 263

and fire emergency plan, 276 governance and, 34, 39, 169 of grievance procedure, 32 and imaging services, 148–151, 173–174 of infection prevention and control program, 75,

77, 80, 170–171 of malignant hyperthermia training, 110 of nursing services, 55 of orientation/training, 70, 110, 170 and overnight care/services, 158, 174 and pathology/laboratory services, 143–144, 173 and pharmaceutical services, 133, 135, 139–

140, 173 privileging/credentialing and, 41, 44–46, 169 quality improvement program and, 62, 64–65,

170 and radiation oncology services, 163, 174 and renal lithotripsy services, 129, 131–132 and research activities, 155, 174 of safety program, 81, 85, 171 and smoke control systems, 269 and surgical/related services, 116, 121, 123–

124, 172–173 of temperature of items, 84 and work-related injury/illness, 88 document/record reviews, 3, 67 doors automatic release, 226 coverings, and laser use, 126 exit, 215–216, 219 electrical system and, 253, 257 identification of, 222 exterior, 213 hardware, cleaning and maintenance of, 90n to hazardous areas, 92n, 227 to medical gas storage, 231 power-operated, 213 self-closing, areas of refuge and, 219 and smoke/fire protection, 265–269 swing-type, 214 requirements for, 212 dopamine, for resuscitation, 204 dosimetrist, 164 dosimetry, 167 draperies, 278 dressing rooms, 90 and surgical/related services, 120 driers, air, 235, 245 drills fire, 276 scenario-based, 104 and emergency planning, 108–109, 203 drinks, handling of, 80, 160 Drug Enforcement Administration (DEA) and pharmaceutical services, 134 privileging/credentialing and, 41–42, 45, 188,

194 drug reactions adverse incident and, 68 in clinical record, 72, 115, 199 drugs. See medications; substance abuse



Index

dry pipe systems, 210 dumbwaiters, 275 dust, facilities/environment and, 90n DVT. See deep vein thrombosis

E Early Option Survey (EOS), 3, 5 and deficiencies, 11–12 ECG. See electrocardiogram education. See health education educational materials, administration and, 51 EES. See Essential Electrical System egress areas of refuge and, 219 configuration and detail, 217–220 identification of, 222–223 lighting, 220–221, 223 means of, 212–223 and vertical openings, 225 See also exits 855B enrollment application, 287 process, 287–289 electrical equipment, 247 electrical power. See power source, alternate electrical shock imaging services and, 149 prevention of, 91 electrical system, 247–258 and high-rise buildings, 272 electric receptacles/switches cleaning and maintenance of, 90n cover plates for, 252 GFCI, 248 for laboratories, 90n motion sensor, 220 requirements for, 247–248 testing of, 249 electrocardiogram (ECG) monitoring, 108 electronic prescribing systems, 137 electronic records/systems, 53 elements of compliance, i, 286 elevators, 275 electrical system and, 253, 255–257 and exit signs, 223 emails, governance of, 38 emergencies, medical management of, standards on, 203 nursing personnel and, 55 quality of care provided and, 60 and radiation oncology services, 165 and surgical/related services, 116 and transfer procedures, 60 Emergency and Standby Power System (EPS),

250, 253 emergency control station, 272 emergency equipment anesthesia care services and, 106 maintenance and accessibility of, 104 orientation and training on, 53 personnel records and, 201 personnel trained with, 82

emergency management agencies, communication/cooperation with, 105–107

emergency planning program, 104–110, 203 drills on, 104 and fire safety, 276 governing body and, 34 and medical gas/vacuum systems, 246 orientation and training on, 53 personnel records and, 201 unified/integrated, 110 and vaccine handling, 140 emergency services overnight care/services and, 159 pathology/laboratory services and, 145 patient information on, 29 types provided, in emergency plan, 105 employee benefit forms, personnel records and,

201 employees adverse incidents and, 68 and fire safety, 86 enclosures, exit, 216 endoscopy procedures, 113, 120n endotracheal tubes, 204 energy-emitting equipment, 125–128 documentation requirements for, 172 energy exposure, hazardous, 150 engineering controls, definition of, 295 Environmental Protection Agency, 295 environmental sensitivities, in clinical record, 72 environment of care, 89–104 checklist for, 3, 205–280 documentation requirements for, 171 governance of, 36 safety of, 75, 80 and surgical/related services, 113, 120, 120n EOS. See Early Option Survey epinephrine, for resuscitation, 204 EPS. See Emergency and Standby Power System Equal Employment Opportunity Commission, 4 equipment administration of, 52 for anesthesia care services, 109, 112 cleaning of, 77 electrical, 247 for imaging services, 149 for infection prevention and control, 79 maintenance of, 103 orientation and training on, 53 and pathology/laboratory services, 146 recall/damage/expiration of, 82 and renal lithotripsy services, 129–130 See also calibration; specific type ergonomic exposure, 80n escalators, 226, 275 Essential Electrical System (EES), 248–258 Critical branch, 252, 254 Equipment branch, 252, 255–257 Life Safety branch, 241, 252–253, 256–257 type 1, 247–255 type 2, 247–252, 255–257 type 3, 247–249, 257–258



Index

ethical practices governance of, 38 and imaging services, 147 and overnight care, 157 and pathology/laboratory services, 141 and pharmaceutical services, 133 and quality of care provided, 57 and radiation oncology services, 163 and renal lithotripsy services, 128 and research activities, 155 ethylene oxide evacuation, 256 evacuation emergency planning for, 105, 107 fire emergency plan and, 276 fire safety requirements and, 103, 262 evaluation/appraisal anesthesia care services and, 107, 199 emergency preparedness drills and, 104, 109,

203 patient rights and, 25 renal lithotripsy services and, 129–130 events reporting to AAACH, 17, 38, 169 See also under adverse incident examination, physical. See physical examination examination rooms, 90 exercises on emergency preparedness, 108 See also drills exhaust, for vacuum systems, 237 exits, 212–223 types of, 212–216 See also egress expenses of organization, administration of, 52 experience and administration, 51 and other qualified health care professionals,

124n and pathology/laboratory services, 143 and privileging/credentialing, 40–41, 193 expiration date, 83, 138 explosion hazard, 227 exposure, hazardous imaging services and, 150 prevention of, 80, 86–87 radiation oncology services and, 166 exposure control plan, 86 orientation and training on, 53 personnel records and, 201 exposure time, definition of, 295 eyewear, protective, and laser use, 126, 128

F facilities of organization, 89–104 administration of, 52 background information, 207 documentation requirements for, 171 existing, 206 governing body and, 35 new, 206 safety and, 81

facility services, definition of, 4 falls hazards and, 91 prevention of, 80 Family Educational Rights and Privacy Act of

1974 (FERPA) training, 53, 153 personnel records and, 201 fans, electrical system and, 256 FDA. See Food and Drug Administration federal government. See regulations, state/federal;

requirements, state/federal feedback, 27 fees for accreditation survey, 4, 7–8 cancellation, 8–9 for Consultative Survey, 8 for Discretionary Survey, 6 for Interim Survey, 6, 8 for Medicare Follow-Up Survey, 6, 8, 14 patient information on, 28–29 for surveys subsequent to deficiencies, 12 fellow, physician, credentialing of, 153n fellowships, privileging/credentialing and, 184–

186 fencing, for medical gas storage, 231 FERPA. See Family Educational Rights and Privacy

Act files. See personnel files/records; records/minutes filters, air, 235, 245 financial data confidentiality of, 71n quality improvement program and, 63n financial management/accountability, governance

of, 35 financial responsibility, patient, 28 fire alarm systems, 260–263, 273 fire department, automatic notification of, 261 fire extinguishing equipment and laser use, 127 personnel records and, 201 portable, 270–271 rechargeable, 271 fire protection, 265–269, 274 fire safety, 86 and corridor separation, 264 facility and, 89n and hazardous areas, 227–228 and laboratories, 224 and laser use, 127 and medical gases, 229–246 orientation and training on, 53 personnel records and, 201 plans, 276 sprinkler shutdown procedures, 103, 262 sprinkler systems, 209–211 and vertical openings, 225 fire watch, 262 fiscal control, 52 floors, vertical opening protection, 225–226 flumenazil, for resuscitation, 204 fluoroscopic imaging, 147



Index

follow-up in clinical record, 197 overnight care/services and, 160 quality of care provided and, 58 radiation oncology services and, 166–167 surgical/related services and, 125 food handling of, 80 reactions, in clinical record, 72 recall/damage/expiration of, 82 Food and Drug Administration (FDA), 82, 84, 118 definition of, 295 and pathology/laboratory services, 146, 146n food service, overnight care and, 160 foyers, 219 fraud, governance of, 35 frozen items, temperature control for, 84 functional relationships, in organization,

governance of, 35 furnishings, 278

G gas appliances, laboratory, 224 gases, medical, 229–246 category 1, 244–245 category 2, 246 piped systems, 229–244 gender, in clinical record, 71, 197 generating units/generator set, 250–251, 253, 256–

258, 273 germicide, definition of, 296 glucagon, for resuscitation, 204 goals. See objectives of organization; performance

goals good faith, acting in, 4, 9, 15–16 governance, 33–50 documentation requirements for, 34, 39, 169 governing body, 33–39 and administration, 51 and anesthesia care services, 104, 111, 124n and electrical system, 248 and imaging services, 147, 151, 151n and infection prevention and control, 75–76 meetings of, 38 and overnight care/services, 158 and patient satisfaction, 70 peer review and, 50 and pharmaceutical services, 140 and privileging/credentialing, 44 and quality improvement program, 62–65 and quality improvement studies, 177, 181 and radiation oncology services, 163, 165 and renal lithotripsy services, 128 and research activities, 155–156 responsibilties and functions of, 34–38 and safety, 80, 86 and surgical/related services, 113–114, 116,

123, 125 government agencies, inquiries from, governance

and, 38 grievances governance of, 35 patient rights and, 27, 31–32

procedure for, 32 review of, policies on, 67 grounding poles, 248 guidelines, state/federal/other and biologic hazard protection, 86 and confused drug names, 136 and food service, 80, 160 and infection prevention and control, 76–78, 80 and laser equipment, 127 and malignant hyperthermia, 110 and medication disposal, 139 and medication storage, 137 and renal lithotripsy services, 129–130 and safety, 83 and surgical/related services, 114, 120 and vaccines, 140, 140n

H HAI. See health care-acquired infection hair protection, 128 hand hygiene, 76 definition of, 296 products for, 76 and surgical/related services, 120 handrails, 213, 217 hand rub. See alcohol-based hand rub hand trucks, 231 hand wash, antiseptic, definition of, 293 harassment, patient rights and, 26 hazard(s) physical, 91 imaging services and, 148–149 radiologic electrical system and, 256 imaging services and, 148–149 safety program and, 80 hazardous areas, 92n, 227–228 egress and, 218 hazardous exposures imaging services and, 150 prevention of, 80, 86–87 radiation oncology services and, 166 hazardous materials/waste, 83 imaging services and, 150 radiation oncology services and, 166 HDR. See High Dose Rate brachytherapy Health and Safety Code, CA, 19–21 health care-acquired infection (HAI), definition of,

296 Health Care Facilities Code, 3, 92, 92n health care industry representatives, as

unauthorized, 66n health care professionals definition of, 296 governance and, 36 and imaging services, 148, 151 impaired/incapacitated, 66 and infection prevention and control, 76 patient responsibilities and, 28 and peer review, 48–50 privileging/credentialing and, 40–48, 57 and quality improvement program, 62 health department, local, and food services, 160



Index

health education anesthesia care services and, 105 on condition/illness, 59 governance of, 36 on infection prevention and control, 76 on laser use, 128 on medical devices, 85 on medications, 138 peer review and, 50 privileging/credentialing and, 183, 193 in surgical settings, elements of, 59n health information, 69–74 documentation requirements for, 170 patient responsibilities and, 28 health information system, 69–74 back-up, 70 person in charge of, 53 Health Insurance Portability and Accountability

Act of 1996 (HIPAA), training on, 53, 153 personnel records and, 201 health status, privileging/credentialing and, 188 heating. See HVAC system hepatitis B immunization, 87 personnel records and, 202 high-alert medications, 135–136, 136n, 137 high complexity testing, 143, 143n–144n High Dose Rate (HDR) brachytherapy, 167 high hazard areas, 227 high-level disinfection (HLD) definition of, 296 processes for, 77 high-rise buildings, 272 HIPAA. See Health Insurance Portability and

Accountability Act of 1996 histopathology, radiation services and, 167 history, medical/health in clinical record, 72–73, 197–198 overnight care/services and, 160 and quality of care provided, 58 renal lithotripsy services and, 130n, 132 surgical/related services and, 114–115 HLD. See high-level disinfection hospital grade disinfectant, definition of, 296 hospitals affiliations, privileging/credentialing and, 185–

186 conditions of participation, 148, 148n overnight care services and, 159 quality of care provided and, 60 housekeeping services, governance of, 37 human cells/tissue, handling of, 118 humidity control, and surgical/related services,

120 HVAC system, 273–274 cleaning and maintenance of, 90n and electrical equipment, 250 and electrical system, 255, 257 and laboratories, 90n and medical gas storage, 231 and smoke/fire protection, 265–266 hydrocortisone, for resuscitation, 204

hyperthermia, malignant. See malignant hyperthermia

hypnotics, 111

I I-9 forms administration and, 52 personnel records and, 201 identification, of patients/site, 71, 122, 122n, 150 identification number, 71, 197 illnesses, work-related, personnel records and, 88 imaging services, 147–152 documentation requirements for, 148–151,

173–174 interpretation, 149 and radiation oncology services, 166 standards of, 147–152 immediate administration, 138, 138n immunizations/immunization programs definition of, 296 personnel records and, 202 for staff, 86 Impairment Coordinator, 211 implant/implantable device cleaning of, 77 definition of, 296 MRI warnings and, 152 presurgical time-out and, 122 radiation oncology services and, 167 improvement. See under quality improvement;

quality management improvement of facilities, checklist for, 209 incentives, administration of, 52 Incident Command Center, 107 incidents, clinical definition of, 68 peer review and, 49 inert gases, 231 infection, post-operative peer review and, 49n prevention of, 59n infection prevention and control, 75–80 documentation requirements for, 75–80,

170–171 governance of, 36, 39 personnel records and, 201 quality improvement and, 61–62 and surgical/related services, 120 information and emergency preparedness program, 106–107 on medications, 134, 138 patient rights and responsibilities and, 25, 27–29,

31 peer review and, 50 privileging/credentialing and, 43–45, 182 research activities and, 156 See also health information information systems, and quality improvement

program, 63



Index

Initial Accreditation Survey, AAAHC, 5, 7 and deficiencies, 11–12 and risk assessment, 81n Initial Medicare Deemed Status Survey, 3, 5 and deficiencies, 11–12 process after, 13 and risk assessment, 81n injection practices/safety, 76 definition of, 296 injuries, physical prevention of, 80 work-related, 88, 202 inlets, for medical gas systems, 240–241 inspection and emergency lighting, 221 of fire alarm system, 262–263 of fire extinguishers, 270–271 and laser use, 126 and medical gas systems, 235, 244 Institutional Review Board (IRB), 155 instructions given on cleaning devices/products, 77, 79–80 in clinical record, 72, 198 on equipment maintenance, 103 on laboratory quality controls, 144 on medical devices, 85 overnight care/services and, 160 surgical/related services and, 120, 125 instruments cleaning of, 77 count of, 121 insulin pumps, MRI warnings and, 152 insurance, and work-related injury/illness, 88 intakes, medical air, 236 Interim Survey, AAAHC, 6–7, 15 process after, 13 interior finishes checklist for, 259 cleaning and maintenance of, 90n intermediate-level disinfectant, definition of, 296 intermediate-level disinfection, definition of, 296 internship, privileging/credentialing and, 183–184 interpretation services, 25 Interpretive Guidelines, CMS for ASCs, 3 for CfCs, 1–2 interviews, 3 and data privacy, 71 and emergency equipment availability, 104 and facilities, 90 and imaging services, 149 and pathology/laboratory services, 143 and pharmaceutical services, 134, 138 and quality of care provided, 57 and radiation oncology services, 164 and safety program, 84 and surgical/related services, 121 intranet, governance of, 38 intravenous infusion pumps, 139 investigations, and work-related injury/illness, 88,

202 in-vitro fertilization, 113 ionizing radiology procedures, 148

IRB. See Institutional Review Board isolation of patient electrical system and, 255–256 and overnight care/services, 159

J job description/functions/demands and imaging services, 148 and orientation/training, 70 personnel records and, 51, 201 job performance. See competence/competencies;

performance

K kidney stones. See renal lithotripsy services kitchen hood supply/exhaust systems, 255–256 knowledge of emergency procedures, 98, 108 of hazardous waste disposal, 83 of laser-specific information, 126 of pharmaceutical laws/regulations, 134 of vaccine guidelines, 140

L labeling for gas lines, 243 See also signage laboratory reports, in clinical record, 73 laboratory services, medical, 141–146 documentation requirements for, 143–144, 173 electrical system and, 248 governance of, 37 outsourcing, 141 physical environment checklist on, 224 written descriptions of, 146, 146n laboratory specimens collection of, pathology/laboratory services and,

145 handling of, quality of care provided and, 58 procedures for, 146, 146n landings, 214–215 language preferences, research consent and, 156 laryngoscopes, 204 laser equipment, 125–128 documentation requirements for, 172 laterality, procedures involving, 121 laundry, 119 chutes, 226 fire regulations and, 278 LDR. See Low Dose Rate brachytherapy legal matters/litigation governance of, 38, 169 quality improvement program and, 63n review of, policies on, 67 legal requirements and abuse allegations, 32 administration and, 51–52 and advance directives, 27 and biologic hazard protection, 86 and credentialing and privileging, 41, 47 and emergency planning, 106 governance and, 35 and imaging services, 147, 149, 152



Index

and other qualified health care professionals, 124n

and overnight care, 157 and pathology/laboratory services, 141 and peer review, 48 and pharmaceutical services, 133–135, 137–139 and quality of care provided, 57 and radiation oncology services, 163–164, 166 and renal lithotripsy services, 128 and research activities, 155–156 and risk management, 67 and safety, 83 and surgical/related services, 115 legislative/executive act, 34 liabilities of organization administration of, 52 release of, privileging and, 43 liability coverage California regulations on, 20 privileging/credentialing and, 41–42, 45, 194 risk management and, 67 students/trainees and, 153 license action, state, privileging/credentialing and,

42 license/licensure, state, 34 administration and, 51 California regulations on, 21 and eligibility, 4 and other qualified health care professionals,

124n and overnight care/services, 157–158 and pathology/laboratory services, 142, 142n,

143, 143n personnel records and, 201 and pharmaceutical services, 133–134 privileging/credentialing and, 40–41, 45, 47, 183,

194 probationary status and accreditation, 15 and privileging, 42, 188 and renal lithotripsy services, 129 Life Safety Code, 3, 91, 91n–92n, 92, 205, 290 Plan of Correction (PoC), 279–280 Life Safety Code Survey, 6 light-based technologies, 125–128 documentation requirements for, 172 lighting, 90 battery-powered, 248–249 egress, 220–221, 223 electrical system and, 256 of signs, 223 LIM. See Line Isolation Monitor Line Isolation Monitor (LIM), 249 liquid level sensors, and medical air systems, 236 lithotripsy services, 113, 128–132 documentation requirements for, 129, 172–173 litigation. See legal matters/litigation locks delayed locking systems, 213 key operated, 213 lockups, 223

logging/tracking, 170 of laboratory specimens/biological products, 58 of maintenance, 126 renal lithotripsy services and, 131 of temperature of items, 84 Low Dose Rate (LDR) brachytherapy, 167 low-level disinfectant, definition of, 296 low-level disinfection, definition of, 296 lubricants, for waste anesthetic gas disposal, 238

M magnesium sulfate, for resuscitation, 204 magnetic hazards, imaging services and, 149 magnetic resonance imaging, 147, 152 maintenance, preventive/ongoing of emergency equipment, 104 of facilities, 90, 90n, 91 of fire alarm system, 262–263 of fire extinguishers, 271 of fire safety equipment, 210 of laser equipment, 126 of medical equipment, 103 of medical gas systems, 244 and pharmaceutical services, 139 and renal lithotripsy services, 131 malignancy, confirmation of, 167 malignant hyperthermia (MH), 110 definition of, 296 Malignant Hyperthermia Association of the United

States (MHAUS), 110n malpractice coverage, patient rights and, 29 management functions, governance of, 38 management of organization, governance of, 35,

51 manifolds, for medical gas containers, 232–234 manuals administration and, governance of, 38 for electrical system, 258 marketing, governance of, 38 masks, filtration, and laser use, 126 materials and laser use, 127 reactions to, 68 in clinical record, 72 See also hazardous materials/waste mattresses, 278 McGill forceps, 204 mechanical equipment room and medical gases, 234 and vacuum systems, 237 mechanical indicator, definition of, 296 media, inquiries from, governance of, 38 Medicaid. See Centers for Medicare & Medicaid

Services Medicaid sanction, 42, 194 medical care, governance of, 37 medical education, privileging/credentialing and,

183 medical error reduction quality improvement program and, 61 safety program and, 80



Index

medical executive committee, 190 medical gas rails (MGR), 241 Medical Laser Safety Officer (MLSO), 126 medical social worker, and radiation oncology

services, 164 medical staff definition of, 296 and peer review, 48–50 privileging/credentialing and, 192 See also staffing requirements Medicare. See Centers for Medicare & Medicaid

Services Medicare Deemed Status (MDS) Program, policies

and procedures, 1–18 Medicare Deemed Status (MDS) Renewal, 17 Medicare Deemed Status (MDS) Survey, 2, 7 additional element, 6 and infection control, 75 preparation for, 290 Medicare deficiencies, 11–14 Medicare Follow-Up Survey, 6–7, 14 process after, 13 Medicare participation, hospitals and, 60 Medicare sanction, 42, 194 medication errors, avoiding, 80, 136–137 medication reconciliation in clinical record, 197 and quality of care provided, 58 medications anesthesia care services and, 106, 110 in clinical record, 198–199 clinical trials of, 155n confused drug names, 135–136, 136n disposal policy, 139 handling of, 134–135 in health history, 115 inventory of, 135 labeling, 138 orders for, written, 135 patient responsibilities and, 28 pediatric, 112, 119 pharmaceutical services and, 133–140 recall/damage/expiration of, 82–83, 139 and renal lithotripsy services, 130, 130n resuscitation, 204 samples, 137 storage and security of, 137 mental health status, privileging/credentialing

and, 42, 194 metal objects/implants, MRI warnings and, 152 MGR. See medical gas rails MHAUS. See Malignant Hyperthermia Association of

the United States microscopy, 143, 143n midazolam, for resuscitation, 204 minutes of governing body meetings. See

records/minutes mirrors, and egress, 217 mission of organization administration and, 51–52 governing body and, 35 and teaching/publishing, 155 mistreatment, grievance procedure for, 32

MLSO. See Medical Laser Safety Officer moderate complexity testing, 143, 143n–144n mold, facilities/environment and, 90n monitoring/surveillance anesthesia care services and, 108–109 of expiration dates, 83 of health information system, 53 imaging services and, 147, 150 and infection prevention and control, 75, 77–78 medical air systems, 236 pharmaceutical services and, 135, 139 and Plan of Correction (PoC), 279 quality improvement program and, 62–63 safety program and, 81 of temperature of items, 84 motion sensors for alcohol-based hand rub dispensers, 228 for light switches, 220 moving walks, 226 multisite organization accreditation, 4 multi-tenant buildings, and fire alarm systems,

263

N naloxone, for resuscitation, 204 National Fire Protection Association (NFPA)

codes, 3, 91, 91n–92n, 92, 205, 211 and building services, 273–274 and construction, 208–210 and corridor separation, 264 and egress, 214–215, 217, 219–222 and electrical system, 247–258 and fire alarm systems, 260–263 and fire emergency plans, 276 and fire extinguishers, 270–271 and furnishings/decorations, 278 and hazardous areas, 227–228 and high-rise buildings, 272 and interior finishes, 259 and laboratories, 224 Life Safety Code, 290 and medical gases, 229–246 and smoke/fire protection, 265–269 and smoking, 277 and vertical conveyors, 275 and vertical openings, 226 National Institute for Occupational Safety and

Health (NIOSH), 296 National Practitioner Data Bank (NPDB), 35n Continuous Query, 42n governance and, 35 privileging/credentialing and, 41, 188, 194 and survey information, 8 National Provider Identifier (NPI) Number, 287, 289 near-miss incidents, 68 policies on, 67 safety program and, 80 nebulizer units, 139 needles. See sharps injury prevention needs/needs assessment, nursing services and,

55 neglect, grievance procedure for, 32 nerve stimulators, MRI warnings and, 152



Index

NFPA. See National Fire Protection Association NIOSH. See National Institute for Occupational Safety

and Health nitroglycerin, for resuscitation, 204 nitrous oxide, 230–231 non-reflective equipment, for laser use, 128 norepinephrine, for resuscitation, 204 Notice of Accreditation, public posting of, 9, 290 notification. See communication/notification NPDB. See National Practitioner Data Bank nurses call systems, 254 certified registered nurse anesthetist, 104, 104n,

106n, 111n notes, and overnight care/services, 160 oncology nurse, 164 stations, 254–255 nursing services and needs of patient, 55 written assignments in, 55 nutritionist, oncology, 164

O objectives of organization administration and, 51–52 governing body and, 35 and teaching/publishing, 155 observation, 3 of anesthesia recovery, 109 and data privacy, 71 of emergency equipment availability, 104 and facilities, 90 of imaging services, 149 of infection prevention and control, 77 of pathology/laboratory services, 143 of pharmaceutical services, 138 of quality of care provided, 57 of radiation oncology services, 164 of surgical services, 121 observers, 10 policies on, 66 occupancy permit, 89n occupational exposure, 86–87 definition of, 297 Occupational Safety and Health Administration

(OSHA) and infection prevention and control, 75 training, 153 personnel records and, 201 and work injury and illness records, 88 officers, responsibilities and functions of, 39 Omnibus Reconciliation Act (1980), 18 on-call coverage overnight care/services and, 158 surgical/related services and, 116 oncologist, radiation, 165 oncology. See radiation oncology treatment services oncology nurse, 164 operating agreement, 34 operating room, 91 definition of, 297

electrical system and, 248 operation, surgical definition of, 113 See also procedure operations of organization emergency preparedness program and, 105 governing body and, 35–36 hospital notification of, 60 operative reports, in clinical records, 73 OPIM. See other potentially infectious materials oral health. See under dental; dentist oral maxillofacial surgeon/services, 111 organization, accreditable and administration, 51 and anesthesia care services, 103 and clinical records/health information, 69–74 and credentialing, 40 definition of, 34 governance of, 33–39 and imaging services, 147 and infection prevention/control and safety, 75 and pathology/laboratory services, 141 and peer review, 48 and pharmaceutical services, 133 and privileging, 46 and quality management and improvement, 61 quality of care provided by, 57 and radiation oncology services, 163 and research activities, 155 and risk management, 66 and surgical/related services, 113 and teaching/publishing, 153 organizational structure/relationships,

governance of, 35 orientation training, 53–54, 154 personnel records and, 201 and renal lithotripsy services, 129 original container/packaging, 138, 138n OSHA. See Occupational Safety and Health

Administration other potentially infectious materials (OPIM),

definition of, 297 other qualified health care professionals, 124n and anesthesia care services, 109 and credentialing, 48 and infection prevention and control, 76 and pathology/laboratory services, 142 and radiation oncology services, 164 and surgical/related services, 115–117, 124 other qualified licensed individuals, definition of,

297 outcomes patient information on, 30 quality improvement program and, 61, 62n, 63,

63n outlets for medical gas systems, 240–241 and smoke/fire protection, 266 outpatient surgery settings (CA), 19 overcurrent protective devices, 247 overnight care and related services, 157–161



Index

documentation requirements for, 158, 174 nature of, 157–158 overnight supplies, surgical/related services and,

125 over-the-counter medications in clinical record, 72, 114–115, 198 patient responsibilities and, 28 oximeter, pulse, 108 oxygen and anesthesia care services, 106 storage of, 230 oxygenation, and anesthesia care services, 108 oxygen mask, 204

P pacemakers, MRI warnings and, 152 PACU. See post-anesthesia care unit pain management, 113 and anesthesia care services, 109 PALS. See pediatric advanced life support paralytics, for resuscitation, 204 parking structures, 209 participation, patient responsibilities and, 28 partnership agreement, 34 pathologist, and pathology/laboratory services,

142 pathology services, 141–146 in clinical record, 72 documentation requirements for, 143–144, 173 governance of, 37 outsourcing, 141 patient(s) age, and surgery, 114 gender, in clinical record, 71, 197 informative discussions with, in clinical record,

71, 73, 198 location tracking in emergency, 105 name, in clinical record, 71, 197 "not responsible," and smoking ban, 277 safety of, 80 unique identifiers for, 80 patient care activities, students/trainees and, 153 patient care areas authorized personnel in, 78 cleaning of, 79 electrical system and, 254–256 patient care responsibilities, nursing service

personnel and, 55 patient education. See health education patient rights and responsibilities, 25–32 governance of, 36, 39 information on, 26 and research activities, 155–156 patient satisfaction, assessment of, 70 patient selection criteria, 117 and renal lithotripsy services, 130 payment policies hospitals and, 60 patient information on, 29 PEC. See Physical Environment Checklist for

Ambulatory Surgical Centers Pediatric Advanced Emergency Assessment,

Recognition and Stabilization® (PEARS), 202

pediatric advanced life support (PALS), 112 personnel records and, 202 pediatric patient care anesthesia care services and, 112 governance of, 36, 169 rooms for, electrical system and, 248 surgical/related services and, 119 peer evaluation, definition of, 297 peer references, privileging/credentialing and, 41,

44, 187, 193 peer review, 48–50 criteria for, 49, 49n definition of, 297 versus performance review, 297 privileging/credentialing and, 44 quality improvement and, 48, 50, 61–63 performance appraisal administration of, 52 personnel records and, 201 quality improvement studies and, 175, 177, 180 performance goals definition of, 297 governing body and, 35–36 priorities for, 61 quality improvement studies and, 176, 178 performance measures definition of, 297 quality improvement program and, 61, 63, 65 performance review, versus peer review, 297 personal protective equipment (PPE) definition of, 297 imaging services and, 149 personnel adverse incidents and, 68 and emergency equipment maintenance, 104 emergency planning and location tracking, 105 names and contact information for, 106 governing body and, 35 and infection prevention and control, 79 and overnight care/services, 158 patient care responsibilities of, 55 patient responsibilities and, 28 and quality management and improvement, 61 and radiation oncology services, 163 safety of, 80 personnel files/records, 51 and imaging services, 151 and quality of care provided, 57 and safety training, 82, 87 worksheet on, 201–202 pharmaceutical services, 133–140 documentation requirements for, 133, 135, 139–

140, 173 responsibility for, 134 pharmacist, licensed, 133 PHI. See protected health information Physical Environment Checklist for Ambulatory

Surgical Centers (PEC), 3, 205–280, 290 physical examination in clinical record, 72–73, 197–199 and overnight care/services, 160 and quality of care provided, 58



Index

and renal lithotripsy services, 132 and surgical/related services, 114–116, 124 physical health issues, privileging/credentialing

and, 42, 194 physician(s) and admitting privileges, 60 and anesthesia care services, 104–107, 109,

111 contact information for discharge, 125 for emergency communication, 96 definition of, 298 disclosure of interests of, 27 and emergency planning, 106 and imaging services, 151, 151n and overnight care/services, 158–159 and pathology/laboratory services, 142 and peer review, 48–50 and pharmaceutical services, 135 and quality improvement program, 62 and radiation oncology services, 163, 165 and surgical/related services, 114, 116, 125 physician assistant (PA), definition of, 298 physicist medical, 163 radiation, 164 piped gas systems, 229–244 Plan of Correction (PoC), 6, 11, 290 California regulations and, 19 for deficiencies, 12, 14 Life Safety Code, 279–280 time period for, 11 plumbing, cleaning and maintenance of, 90n poisoning, prevention of, 91 policies and procedures, 1–18 and administration, 51–52 and advance directives, 31 and anesthesia care services, 105, 109, 111 and clinical records, 70, 73 and electrical equipment, 247 and emergency preparedness, 105–106,

108–109 and equipment maintenance, 103 and fire prevention/safety, 86 and governance, 34–36, 39, 47 and grievances, 32 and imaging services, 149–150, 152 and infection prevention and control, 75–76, 78,

80 and laboratory environment, 224 and overnight care/services, 159 and pathology/laboratory services, 144–145 and peer review, 49–50 personnel records and, 201 and pharmaceutical services, 135–140 and publishing, 154 and quality of care provided, 58 and radiation oncology services, 163, 165–166 and renal lithotripsy services, 129–131 and research activities, 155–156 and risk management, 66

and safety, 80, 82–83, 89 and surgical/related services, 113–114, 116–

117, 121 and teaching activities, 153–154 and transfer procedures, 60 population served and emergency equipment, 104 and emergency preparedness program, 105, 110 hospital notification of, 60 port film, 165 positive pressure supply systems, 232, 242 post-anesthesia care unit (PACU), 109 post-exposure evaluation, 87 definition of, 298 post graduate education, privileging/credentialing

and, 184–185 postgraduate trainee. See student/postgraduate

trainee posting. See communication/notification post-operative care. See recovery/recovery area power source, alternate, 248–250, 258 definition of, 293 and egress lighting, 220–221 and fire alarm systems, 261 and high-rise buildings, 272 and overnight care/services, 160 PPE. See personal protective equipment practice, scope of. See scope of services/practice preceptorships, privileging/credentialing and,

184–185 pregnancy, imaging services and, 150 prescription pads, safety measures for, 137 prescriptions in clinical record, 72, 198 in health history, 115 security measures, 137 surgical/related services and, 125 pressure indicators, for medical gases, 232, 241 prevention services/measures, patient education

on, 59, 59n primary care settings, clinical records and, 74, 74n primary source verification, 43n, 45, 47 definition of, 298 privacy. See confidentiality/privacy privileges, clinical staff administration of, 52 application for, 169, 182–192 denial of, on application, 42, 194 and energy-emitting devices, 113–114, 116, 123,

125 and overnight care/services, 158 quality of care provided and, 42 and radiation oncology services, 163 suspension/termination of, 41–42 temporary, 190 privileging, 40n and anesthesia care services, 104, 107 applications for, 41–43, 46, 169 definition of, 298 documentation requirements for, 41, 44–46, 169 governance of, 40–48



Index

and imaging services, 148, 151, 151n peer review and, 48–50 process for, 40–42, 46 timeframe for, 40 procedure (medical) in clinical record, 72, 198 credentialing and, 47 imaging services and, 147 intended, verification of, 121 limits on, 113 patient rights and responsibilities and, 30 privileging/credentialing and, 46–47 term, 113 time-out and, 122 procedures and policies. See policies and

procedures procedure site of patient, 120, 122, 122n imaging services and, 150 peer review and, 49n procedure/treatment areas cleaning of, 79 definition of, 298 overnight care/services and, 160 radiation oncology services and, 166 products sold, governance of, 35 professional development, peer review and, 48–50 professional education, privileging/credentialing

and, 183 professional liability, privileging/credentialing

and, 187 professional practice and imaging services, 147 and overnight care, 157 and pharmaceutical services, 133, 135 and quality of care provided, 57 and radiation oncology services, 163 and renal lithotripsy services, 128 and research activities, 155 professional societies, privileging/credentialing

and, 186 prognosis information, patient and, 25 progress notes, in clinical record, 73, 198 propofol, 111 proportioning systems, for medical gases, 232,

236, 242 protected health information (PHI), 8 protective environment rooms, electrical system

and, 256 protocols and malignant hyperthermia, 110 peer review and, 49n and research activities, 156 provider, right to change, 27 provider group, and admitting privileges, 60 Provider Performed Microscopy Certificate, CLIA,

142 publication activities, 153–154 documentation requirements for, 174 public health authorities, 78 pulmonary embolism, prevention of, 59n pumps compressor, 235 electrical system and, 256

insulin, MRI warnings and, 152 intravenous infusion, 139 simplex, 235, 237 sump, 255 purchasing, administration of, 52

Q QA. See quality assurance QAPI. See quality assessment and performance

improvement QI. See under quality improvement qualifications and fire safety, 262 and imaging services, 148, 151 and overnight care/services, 158 and pathology/laboratory services, 143 personnel records and, 51, 201 and pharmaceutical services, 133 and privileging/credentialing, 40, 46 and quality of care provided, 57 and radiation oncology services, 163–164 quality assessment and performance

improvement (QAPI) program, 61 governing body and, 34 written, 62 quality assurance (QA), definition of, 298 quality control and pathology/laboratory services, 144 and radiation oncology services, 163, 165 quality equation, 176 quality improvement (QI) program, 61–68 definition of, 298 documentation requirements for, 62, 64–65, 170 and infection prevention and control, 75 number and scope of projects in, 65 quality management and improvement and, 61 resources for, 291 quality improvement (QI) study building, 177 current, definition of, 64n definition of, 298 meaningful, development of, 175–181 quality indicators, 61, 63 and quality improvement program, 64 quality management and improvement, 61–68 governance of, 38 and overnight care/services, 161 and peer review, 48, 50 quality monitoring, 62–63 data collection and, 64 definition of, 298 quality of care provided, 57–60 documentation requirements for, 170 governance of, 36 quality management and improvement and, 61,

77 quantitative measures, quality improvement

program and, 175



Index

R radiation equipment, for renal lithotripsy services,

129 radiation exposure, 166 radiation hazards, imaging services and, 148–149 radiation oncologist, 165 radiation oncology treatment services, 163–167 documentation requirements for, 163, 174 radiation physicist, 164 radiation safety, 163 radiation safety committee, 163 radiation safety officer, 163 radiation technologist, 164 radiographic imaging, 147–148 in clinical record, 73 governance of, 37 radiologic hazards, electrical system and, 256 radiologist, 151, 151n ramps, 215–216 Random Survey, AAAHC, 6–7 process after, 13 Reaccreditation Survey, AAAHC, 5, 17 and deficiencies, 14 and risk assessment, 81n reagents, 146n recall/damage/expiration of, 83 reappointment, definition of, 298 reappointment process. See

appointment/reappointment recall of products/medications, 82 receivers, 235, 237, 244 reception areas, 90 recommendations, in clinical record, 169 Record of Completion, fire alarm systems, 260 records/minutes administration and, 51 of bloodborne pathogen exposure, 87 governance of, 38, 169 imaging services and, 150 of medications, 137 quality improvement program and, 64 See also clinical records; personnel files/records recovery/recovery area, 91, 107, 109, 117, 124, 254 recredentialing definition of, 298 See also credentialing reference letter, sample, 191 references, personnel files and, 201 referrals/consultations in clinical record, 73 quality of care provided and, 59 radiation oncology services and, 166 reflex withdrawal, from painful stimulus, 103 refrigerated items, temperature control for, 84 refusal of care, policies on, 66 registered nurse (RN) definition of, 299 and nursing services, 55 and overnight care/services, 158–159 and pharmaceutical services, 135

and surgical/related services, 124 Registration, Compliance or Accreditation,

Certificate of, CLIA, 142 regulated waste, definition of, 299 regulations, state/federal and abuse allegations, 32 and advance directives, 27 and building codes, 89 California on, 19–21 and imaging services, 149 and other qualified health care professionals,

124n and pharmaceutical services, 134, 138–139 and quality of care provided, 57 and radiation oncology services, 166 and risk management, 67 regulators, air, 235, 245 renal lithotripsy services, 113, 128–132 documentation requirements for, 129, 172–173 renovation of facilities checklist for, 209 safety and, 81 repair of facilities checklist for, 209 and smoke/fire protection, 268 reportable conditions, 78 reportable events, 67 reports/reporting in clinical record, 72–73, 198 emergency systems and, 221 imaging services and, 148–149 laboratory services and, 146n peer review and, 50 pharmaceutical services and, 135 quality improvement studies and, 177 radiation oncology services and, 166 safety program and, 80 work-related injury/illness and, 88 representative of patient, 25–26 and advance directive, 31 and grievance procedure, 32 and patient rights, 30 and surgical/related services, 116 reprisal, patient rights and, 26 reprocessing/reprocessor, of medical devices, 84 requirements, state/federal and credentialing and privileging, 41, 47 and emergency preparedness, 105 and imaging services, 147, 149 and infection prevention and control, 75–76 and pathology/laboratory services, 143, 145 and safety, 80 and work-related injury/illness, 88 rescue agent, 137 research activities, 155–156 in clinical record, 73, 198 documentation requirements for, 155, 174 types of, 155n residency programs, privileging/credentialing

and, 184 residents, credentialing of, 153n



Index

residual radiation, testing for, 167 resources infection prevention and, 79 research activities and, 155 toolkit and Standards, 292 respect, patient rights and responsibilities and,

25, 28 response times for patient follow-up for problems/abnormal

findings, 58 policies on, 67 responsibility anesthesia care services and, 105 governing body and, 34–38 overnight care/services and, 159 pathology/laboratory services and, 143 pharmaceutical services and, 134 responsible adult, and anesthesia discharge, 125 responsible party, in clinical record, 71, 197 restricted area, definition of, 299 restroom facilities, 90 results, reporting pathology/laboratory services and, 144 quality improvement program and, 62, 65 quality of care provided and, 58 resume, personnel records and, 201 resuscitation equipment, 106, 204 pediatric, 112 resuscitative agents, 110 resuscitator bag, 106 retention of records. See personnel files/records revenues of organization, administration of, 52 reversal agent, 137 reviews, annual/ongoing, 39 of emergency preparedness program, 105, 109 governance of, 169 overnight care/services and, 161 peer, 49 policies on, 68 quality improvement program and, 62, 78 radiation oncology services and, 163, 165 research activities and, 155 risk management program and, 67 safety program and, 86 rewards, administration of, 52 rights, patient. See patient rights and responsibilities risk assessment anesthesia care services and, 106 and electrical system, 248 and emergency preparedness program, 105,

108, 110 infection prevention and, 75, 86 safety program and, 81 risk management, 66–68 documentation requirements for, 170 governance of, 36 orientation and training on, 53 personnel records and, 201 quality improvement and, 61–62 RN. See registered nurse rooftop exits, 219 rubbish chutes, 226 rucuronium, for resuscitation, 204

rules and regulations administration and, 51–52 governing body and, 35 and quality of care provided, 57–58 for safety, 83, 86 See also regulations, state/federal rust, facilities/environment and, 90n

S safety/safety program, 75, 80–88 clinical records and, 70 documentation requirements for, 81, 85, 171 energy-emitting equipment and, 125–128 facility and, 89 governance of, 36, 39 imaging services and, 148–149 orientation and training on, 53 overnight care/services and, 160 pathology/laboratory services and, 146 patient rights and, 26 quality management and improvement and, 61,

62n, 63 radiation oncology services and, 163, 166 renal lithotripsy services and, 131 risk management and, 67 surgical/related services and, 113 saline container, and laser use, 127 sanctions and denial/revocation, 16 privileging/credentialing and, 42, 188 scope of services/practice governance of, 35, 39 imaging services and, 149 overnight care/services and, 158 pathology/laboratory services and, 144 quality improvement program and, 62, 62n, 65 research activities and, 155 screening, 147 sealants, for waste anesthetic gas disposal, 238 secondary source verification, 43n, 45, 47 definition of, 299 security practices, 52, 89 and data, 51 and health information, 70–71, 71n and medications, 137 and work-related injury/illness records, 88 sedation deeper-than-intended level of, 111 minimal definition of, 103 standards on, 104–107 sedation/analgesia deep definition of, 103 emergency management and, 203 standards on, 108–112 moderate definition of, 103 emergency management and, 203 standards on, 108–112 sedatives, 111 seeds, radioactive, 167 self-assessment, pre-survey, 2, 290



Index

on infection control, 75 self-referral, governance of, 35 sensitivities. See allergies/sensitivities SEPSS. See Stored Emergency Power Supply

System services, scope of. See scope of services/practice setups, for radiation oncology, 165 shafts, 225 sharps count, 121 sharps injury prevention, 78 orientation and training on, 53 personnel records and, 201 sheltered patients, location tracking in

emergency, 105 shelter in place, 106 shielding, 150 signage for alcohol-based hand rub storage, 228 for areas of refuge, 219 electrical system and, 256 exit/emergency, 213, 222–223 and imaging services, 150, 152 and laser use, 126 for medical gas storage, 229 "no smoking," 277 for sprinkler systems, 210 tactile, 222 signature, dated in clinical record, 72 privileging/credentialing and, 43–44 significant changes and appeal, 23 continuation of accreditation following, 17 simulations of treatment, radiation oncology

services and, 166 single-use devices, reprocessing of, 84 site (bodily). See procedure site of patient site of treatment. See patient care areas;

procedure/treatment areas skin injury, prevention of, 80 and laser use, 128 SMART goals, quality improvement studies and,

176 smoke compartments, 260 exits for, 218 smoke control systems, electrical system and,

255 smoke evacuators, and laser use, 126 smoke protection, 265–269, 274 smoking, 90, 277 soap antimicrobial, 120 definition of, 293 plain/non-antimicrobial, definition of, 298 social worker, medical, and radiation oncology

services, 164 soil, cleaning and, 90n sole proprietorship, governance of, 34 solo provider/practitioner and Interim Survey, 15 peer review and, 48

privileging/credentialing and, 44n, 46, 169, 195 solutions (medical) and laser use, 127 recall/damage/expiration of, 83 space, sufficient, 90 for imaging services, 149 for infection prevention and control, 79 for laboratory services, 146 for medical gas storage, 231 space heaters, portable, 274 Spaulding classification, definition of, 299 specialists clinical records on, 74, 74n See also referrals/consultations specimens, procedures for, 145 sponge count, 121 sprinkler systems, 209–211 and corridor requirements, 218 and corridor separation, 264 and egress requirements, 219 and fire alarm systems, 261, 263 and furnishings/decorations, 278 and hazardous areas, 227–228 and high-rise buildings, 272 Impairment Coordinator, 211 and interior finishes, 259 shutdown procedures, 103, 262 and smoke/fire protection, 266, 268 and vertical openings, 225–226 SSI. See surgical site infection staff. See personnel staffing requirements and infection prevention and control, 79 and nursing services, 55 and overnight care/services, 158–159 and quality improvement program, 63 and quality of care provided, 57 and radiation oncology services, 164–165 and surgical/related services, 117 stairs areas of refuge and, 219 egress, 213–216, 226 fire escape, 216 pressurization systems, 255 spiral, 214 winders, 214 standard-level deficiency, 12–14 standards, state/federal. See regulations,

state/federal; requirements, state/federal standards, AAAHC, 2–3 ambulatory surgical centers, 207–278 applicable version of, 2 application of, 2 California and, 19–21 comments and suggestions, 2 and denial/revocation, 15 emergencies, management of, 203 governance of, 35 imaging services, 147–152 and Medicare CfCs, 283–285 not applicable to MDS Accreditation, 111



Index

patient rights and responsibilities, 25–32 quality improvement program, 61 radiation oncology treatment services, 163–167 rating methodology, revised, 286 revisions v41, i, 281–282 risk management and, 66–68 and smoking ban, 277 teaching/publishing, 153–154 and toolkit, 292 Standards Development Committee, 2 standards of practice/care and infection control, 75 and nursing services, 55 and pharmaceutical services, 134–135, 138 and quality of care provided, 57–58 and surgical/related services, 115, 124 standpipe systems, fire, 210 and high-rise buildings, 272 states. See regulations, state/federal; requirements,

state/federal steps, height of, 213–214 sterile, definition of, 299 sterilization (of items) definition of, 299 electrical system and, 257 and laser use, 126 processes for, 77 stimulus, painful, reflex withdrawal from, 103 stopcocks, 204 storage of alcohol-based hand rub, 228 of blood/blood products, 118 of diagnostic images, 152 of food and drink, 160 of laboratory specimens/biological products, 58,

145 of medical gases, 229–231 of medications, 137 of radioactive materials, 166 of vaccines, 140 Stored Emergency Power Supply System

(SEPSS), 249–251 student/postgraduate trainee administration and, 52 anesthesia care services and, 104 governance of, 37 teaching activities and, 153–154 studies. See clinical studies; diagnostic studies;

quality improvement study substance abuse, privileging/credentialing and,

42, 188, 194 succession, emergency preparedness program

and, 105 succinylcholine, for resuscitation, 204 suction, source of (i.e., wall) electrical system and, 254, 256 and laser use, 126 and resuscitation, 204 summary of medical history, in clinical records,

74, 199 sump pumps, 255 supervision

and anesthesia care services, 104, 104n, 105, 109, 111n

close and adequate, 154 and pathology/laboratory services, 143 and quality of care provided, 57 and radiation oncology services, 167 and surgical/related services, 114 supplements, dietary, patient responsibilities and,

28 supplies administration of, 52 cleaning of, 77 for imaging services, 149 for infection prevention and control, 79 for laboratory services, 146, 146n and laser use, 127 overnight, surgical/related services and, 125 recall/damage/expiration of, 82–83 for renal lithotripsy services, 129–130 support services, and radiation oncology

services, 166 support staff, clinical definition of, 294 and radiation oncology services, 165 supralaryngeal devices, 204 surfaces of facility, cleaning and maintenance of,

90n surfactant, definition of, 299 surge needs, emergency planning and, 106 surgical and related services, 113–132 credentialing and, 47 documentation requirements for, 116, 121,

123–124, 172–173 environment for, 91 infection control and, 75 patient rights and, 27 pediatric, 119 surgical hand scrub, definition of, 299 surgical site infection (SSI), definition of, 299 surgical site prep/marking. See procedure site of

patient surgical team, and time-out, 122 surrogate. See representative of patient surveillance. See monitoring/surveillance surveyors access issues, and denial/revocation, 16 additional, 10 conduct of, 10 travel arrangements, 9 as unauthorized, 66n surveys accreditation, 3 cancellation of, 8–9 concluding, 11 eligibility for, 3–4 initial, 5, 7, 11–12, 81n preparation for, 9 scheduling, 8–9 consultative, 8 discretionary, 6–7, 13 early option, 3, 5, 11–12 initial, 5, 7, 11–12, 81n interim, 6–7, 13, 15



Index

Medicare Deemed Status, 2, 6–7, 75, 290 initial, 3, 5, 11–13, 81n Medicare Follow-Up, 6–7, 13–14 of patient satisfaction, 70 quality improvement program and, 63n random, 6–7, 13 reaccreditation, 5, 14, 17, 81n types of, 4–5, 7 survey team, 10 additions to, 10 syringes. See sharps injury prevention

T teaching activities, 153–154 documentation requirements for, 174 and renal lithotripsy services, 130 teaching agreements, 153 team. See surgical team; survey team techniques, clinical trials of, 155n telephone triage service, governance of, 37 teletherapy, and radiation oncology services, 166 temperature, body, 108, 110 temperature monitoring and medical air systems, 236 and medical gas storage, 230 safety program and, 84 and surgical/related services, 120 and vaccine storage, 140 1095 Learn Portfolio, 291 1095 Strong, i, 291 terrorism, 80n testing of electrical equipment, 247, 249, 251–252, 258 of emergency lighting, 221 of energy-emitting devices, 126 of fire alarm system, 262–263 of medical gas systems, 243–244 of personal protective devices, 149 of smoke/fire protection, 269, 271 test kits, 146 tests, reports of. See diagnostic studies/reports threats, potential, safety program and, 80, 80n thresholds, heights of, 213 time-out, and surgical/related services, 122 tissue debris, 123 in clinical record, 72, 198 and laser use, 126 tissue protection, 80 tissues, human, handling of, 118 tongue blades, 204 tracking/logging. See logging/tracking trainee. See student/postgraduate trainee training, 53–54, 154 and anesthesia care services, 105, 110 and chemical exposure, 87 documentation of, 70, 110, 170 and emergency planning, 108–109 and imaging services, 148 and infection prevention and control, 76, 80 and laser operation, 126 and overnight care/services, 158

and pathology/laboratory services, 143 and pediatric advanced life support, 112 personnel records and, 201 and pharmaceutical services, 139–140 privileging/credentialing and, 40–41, 184–185,

193 and quality improvement program, 63 and radiation oncology services, 164 and renal lithotripsy services, 129 and safety program, 82, 87 training institution, written agreement with, 153 transfer agreement, 60, 159, 170 transfer switches, 247, 249–252, 258, 273 transfer/transition of care anesthesia care services and, 110 California regulations on, 20 overnight care/services and, 159 quality of care provided and, 59 surgical/related services and, 124 transporting/transportation emergency planning for, 105 of laboratory specimens/biological products, 58,

145 patient responsibilities and, 28 of vaccines, 140 trash containers, 278 trauma, prevention of, facility and, 91 travel medicine, definition of, 299 treatment alternatives in clinical record, 73, 198 surgical/related services and, 116 treatment areas. See patient care areas;

procedure/treatment areas treatment site of patient. See procedure site of

patient treatment/treatment plan in clinical record, 197 patient education on, 59 patient rights and responsibilities and, 25, 28, 30 and quality of care provided, 58 radiation oncology services and, 166 renal lithotripsy services and, 130 transfer information on, 124 tribal requirements emergency preparedness program and, 105–107 infection prevention and control and, 75 triggering agents. See resuscitative agents tuberculosis detection and prevention program,

86

U ultrasonic imaging, 147 unauthorized persons, policies on, 66 Underwriters Laboratory, 223, 265 uninterruptable power supply (UPS), 261 universal precautions, definition of, 299 university affiliations, privileging/credentialing

and, 185–186 upholstered furnishings, 278 urologist, 128 utilities, 273–274



Index

V vaccine(s) definition of, 299 expiration dates of, 135, 139 recall/damage/expiration of, 82 for staff, 86 storage and handling of, 140, 140n vacuum indicators, for medical gases, 241 vacuum systems, 229–244 category 1, 244–245 category 2, 246 sources for, 237 and waste anesthetic gas disposal, 238 validation/verification administration and, 52 of allergy/sensitivity information, 72 of credentials, 40, 43, 47 of intended procedure, 121–122, 199 pathology/laboratory services and, 144, 144n of references, personnel files and, 201 surgical/related services and, 121 valves future, 240 main line, 239 for medical gases, 232–235, 237–239, 245 riser, 239 service, 239 shutoff, 239 in-line, 240 for laboratories, 224 source, 238 for sprinkler systems, 210 zone, 240 vasopressin, for resuscitation, 204 vendors and clinical education, limits on, 85 and renal lithotripsy services, 129 and safety program, 84 venous thromboembolism, prevention of, 59n ventilation, 90, 108 and electrical system, 255–257 and explosion hazards, 227 and laboratories, 224 and medical gas storage, 230–231, 233 See also HVAC system verification. See validation/verification vertical conveyors, 275 vertical opening protection, 225–226 and smoke/fire protection, 267 violence in workplace, 80n visas administration and, 52 personnel records and, 201 vision panels, 264, 266–269 visitors of patients adverse incidents and, 68 facilities and, 89–90 patient responsibilities and, 28

volunteers contact information, for emergency

communication, 96 emergency planning and, 106, 108 fire safety and, 86

W WAGD. See waste anesthetic gas disposal waiting area, 91 waivers, 91n–92n emergency planning and, 106 wall finishes checklist for, 259 cleaning and maintenance of, 90n waste hazardous, disposal of, 83 regulated, definition of, 299 waste anesthetic gas disposal (WAGD), 232, 238,

242–243, 245–246 electrical system and, 256 water container, and laser use, 127 water level sensors, and medical air systems, 236 wayfinding, 222–223 welfare of patient research activities and, 156 risk management and, 66 wet environment of operative field, and laser use,

127 wet pipe systems, 210 wet procedure locations, electrical system and,

248 wheelchair spaces, areas of refuge and, 219 WHO. See World Health Organization winders (stairs), 214 windows coverings, and laser use, 126 and egress, 217 hardware, cleaning and maintenance of, 90n and smoke/fire protection, 267, 269 workers' compensation laws, definition of, 300 work injuries/illnesses, personnel records and, 88,

202 workplace, hazards in, 80n work practice controls, definition of, 300 worksheets clinical records, 197–200 credentialing records, 193–196 Infection Control Surveyor, 75 personnel records, 201–202 World Health Organization (WHO), 76 written policies/programs. See documentation

X x-rays. See radiation equipment; radiographic

imaging

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