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Surviving an Accreditation Survey in Sterile Processing SHC © Rose Seavey MBA, BS, RN CNOR, CRCST, CSPDT SEAVEY HEALTHCARE CONSULTING ® STERILE PROCESSING SURGICAL SERVICES . Established in 2003 1 Objectives Identify accreditation standards that pertain to high- level disinfection and sterilization. Describe current published standards and guidelines for healthcare facilities that perform sterilization and/or high level disinfection. Develop a plan for “how to be prepared” for your next accreditation survey. 2 SHC © Risk Reduction and Process Improvement are the Heart and Soul of Accreditation Surveys SHC © 3 Accreditation Survey Improving the quality of health care Peer review Focus on safety, quality, and process improvement Condition of payment Private insurance companies Federal funding Measures compliance Published recommended practices Accreditation standards and supporting documents Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. 2014. 4 SHC ©

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Surviving an Accreditation Survey in Sterile Processing

SHC ©

Rose Seavey MBA, BS, RN CNOR, CRCST, CSPDTSEAVEY HEALTHCARE CONSULTING®

STERILE PROCESSING SURGICAL SERVICES . Established in 2003

1

Objectives• Identify accreditation standards that pertain to high-level disinfection and sterilization.

• Describe current published standards and guidelines for healthcare facilities that perform sterilization and/or high level disinfection.

• Develop a plan for “how to be prepared” for your next accreditation survey.

2SHC ©

Risk Reduction and Process Improvement are the Heart and Soul of Accreditation

Surveys

SHC © 3

Accreditation Survey

• Improving the quality of health care – Peer review– Focus on safety, quality, and process improvement

• Condition of payment– Private insurance companies– Federal funding

• Measures compliance– Published recommended practices – Accreditation standards and supporting documents

Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. 2014.

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Centers for Medicare & Medicaid Services (CMS)Compliance with Medicare Conditions

Accrediting organization with deeming authority by CMS• Accreditation Association for Ambulatory Healthcare (AAAHC)• Accreditation Commission for Healthcare (ACHC)• American Association for Accreditation of Ambulatory Surgery

Facilities (AAASF)• American Osteopathic Association/Healthcare Facilities

Accreditation Program (AOA/HFPA)• Center for Improvement of Healthcare Quality (CIHQ) - new

8/9/2013• Community Health Accreditation Program (CHAP)• DNV Healthcare (DNV)• The Joint Commission (TJC)

Policy and Requirements for an Application for Deeming Authority. Accessed 7/12/2012 at: http://www.cms.gov/Medicare/Provider- Enrollment-andCertification/SurveyCertificationGenInfo/downloads//applicationrequirements.pdf

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• Independent, nonprofit

• Accredits and certifies over 18,000 health care organizations and programs including:– Hospitals, – Doctor’s offices,– Nursing Homes,– Office-based surgeries, – Behavioral health treatment facilities, and – Providers of home care services.

• Nationally recognized as symbol of quality

6SHC ©

TJC Survey Process

• Submit an application • Pay a fee• Resurveyed within three years• 2006 unannounced survey process

• Between 18 and 39 months after previous survey• Morning of survey

• Biographies and pictures of surveyors assigned

Eiland, John E, Surveyor, The Joint Commission. Joint Commission presentation at IAHCSMM annual meeting in May 2013. Presentation available on flash drive provided to attendees.

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Joint Commission ResourcesNonprofit affiliate of TJC, publishes the official handbooks used in the TJC survey process

• Comprehensive Accreditation Manual for Hospitals: The Official Handbook (CAMH)

• Comprehensive Accreditation Manual for Ambulatory Care (CAMAC)

• 2013 Comprehensive Accreditation Manual for Office-Based Surgery Practices (CAMOBS)

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Accreditation Standards

• Standards = performance objectives

• Rationales = describe importance

• Elements of Performance (EPs) = meet goals• Scores determine the

compliance • Minimum score of 90%

on every EP

• Standards relating to reprocessing • Environment of Care • Human Resources • Infection Prevention

and Control • Leadership • Performance

Improvement

Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. 2014.

9SHC ©

TJC Focus on Reprocessing

…beginning in 2010, surveyors have spent additional time during survey evaluating the cleaning, disinfection, and sterilization (CDS) processes

• Surveyors received in-depth training on sterilization processes through AAMI• Survey to ANSI/AAMI ST79 • ST79 Available to staff

http://www.jointcommission.org/assets/1/18/jconline_July_20_11.pdfEiland, John E, Surveyor, The Joint Commission. Joint Commission presentation at IAHCSMM annual meeting in May 2013. Presentation available on flash drive provided to attendees.

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TJC Second Generation Tracer – 2013• “The organization reduces the risk of infections associated

with medical equipment, devices, and supplies”Deficiencies:• 47% Hospitals • 43% Critical access hospitals• 37% Ambulatory care organizations• 26% Office based-surgery practices

• Leadership, IPC, OR, Sterile Processing, ES, and Engineering – all play a CRITICAL ROLE in reprocessing.

• Standardizing the use of HLD and sterilization practices

The Joint Commission. High-level Disinfection and Sterilization: Know Your Practice. Feb. 2014; 34(2):9-13

11 SHC ©

TJC Facilities Out of Compliance1. Not using current evidence-based guidelines (EBG) (IC.01.05.01 EP 1)

2. Orientation, training, and competency not conducted by personnel trained on recentEBG (IC.02.02.01)

3. Lack of quality control and manufacturers’ instructions for use (IFU) - using nonvalidated conditions (concentration, exposure times, and temperatures)

4. Lack of participation and collaboration with IPC (IC.0202.01)

5. Recordkeeping - “incomprehensible” or non-standardized logs (IC.0202.01 EP 2)Traceable path to the patient and product identification in the event of a recall

The Joint Commission. High-level Disinfection and Sterilization: Know Your Practice. Feb. 2014; 34(2):9-13

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Most Frequently Scored Standards 2014

Patton Healthcare Consulting Newsletter, April 2015

56% EC.02.06.01Safe and Functional Environment EP 13 Temp. and Humidity

OR, Sterile Storage and SP (clean and dirty)•Staff know required temperature and humidity parameters• Log each day (paper or automation)

•Must have mandatory feedback

53% EC.02.05.01Risks with Utility Systems

Positive vs. Negative airflow•Staff know what it is and what they can do to maintain appropriate pressure

52% IC.02.02.01Reduce Risk of Infection

Cite any deviation from perfect compliance•More places performing sterilization or HLD the more risks you have•AAMI ST58 2013

36% EC.02.02.01Manage Risks Related to Hazardous Materials

Eyewash in Immediate Area•Plumbed•Inspection and documentation weekly•Evaluate new products

CMS – Infections and ERCP Scopes April 3, 2015

• Looking for compliance with CDC and FDA advice• Opening conference ask if duodenoscopes are used

• Ask for copy of MFG IFU • Surveyor must observe endoscope being processed

• Any identified noncompliance must be cited • Risk for immediate jeopardy

• Strictly and meticulously follow MFG IFU cleaning and reprocessing

• Adhere to nationally recognized guidelines

• ADVICE – Rewrite polices and redo competency validation

https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-15-32.pdf

TJC Personnel Considerations

• HR.01.06.01: Staff are competent to perform their responsibilities

– EP 1. The facility defines the competencies it requires of its staff…

– EP 2. The facility uses assessment methods to determine the individual’s competence…– Test taking, return demonstration, or the use of

simulation.– EP 3. An individual with the educational

background, experience, or knowledge …assesses competence.

The Joint Commission. 2014 Hospital Accreditation Standards (HAS)

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Leadership Standards and EPs

• LD.04.01.11: The facility makes space and equipment available as needed for the provision of care, treatment, and services.

– EP 2. The arrangement and allocation of space supports safe, efficient, and effective care, treatment, and services.• Need for sufficient space to adequately reprocess

– EP 5. The leaders provide for equipment, supplies, and other resources.

The Joint Commission. 2014 Hospital Accreditation Standards (HAS)

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CMS Surveyor Worksheets

• Focus on patient safety and reducing Healthcare Acquired Infections (HAI)

Infection Control WorksheetModule 1: Infection Control/Prevention ProgramModule 2: General Infection Control ElementsModule 3: Equipment ReprocessingModule 4: Patient TracersModule 5: Special Care Environments

https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/downloads/SCLetter12_01.pdf

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CMS Pre-Decisional Surveyor Worksheet

• Module 1: Infection Control/Prevention Program

“1. A.3 The Infection Control Officer(s) can provide evidence that the hospital has developed general infection control policies and procedures that are based on nationally recognized guidelines and applicable state and federal law.”

https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/downloads/SCLetter12_01.pdf

18 SHC ©

Standards & Guidelines• AORN Guidelines for Perioperative Practices, 2015

• AAMI ST79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 &A4:2013

• AAMI ST58:2013 Chemical sterilization and high-level disinfection in health care facilities

• AAMI ST41:2008 (R2012) Ethylene Oxide SterilizationIn Health Care Facilities: Safety And Effectiveness

• AAMI ST91:2015 Flexible and semi-rigid endoscopeprocessing in health care facilities

• CDC Guideline for Decontamination and Sterilization in Healthcare Facilities, 2008 SHC ©

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All the tools and resources needed for the Sterile Processing Team, all in one product!

AORN Guidelines and Tools for Sterile Processing Team includes:

• 8 AORN Guidelines• 22 Policy and Procedure Templates• 24 Competency Verification Tools • 2 Sterile Processing Job Descriptions • 4 Crosswalks from the AORN Guidelines to the AAMI standards

Newly Released Sterile Processing Collection

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Memo Aug. 2014Change in IUSS Terminology

• IUSS not an appropriate substitute for maintaining a sufficient inventory of instruments.

• IUSS survey procedure• Using IUSS in a manner that places patients at risk • No to any survey question • Infection Control Citation

• IUSS Position statement

http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-44.pdf - accessed 12/21/2014 21

SHC ©

http://www.aami.org/publications/standards/ST79_Immediate_Use_Statement.pdf

CMS – Change in IUSS Terminology

• IUSS not an appropriate substitute for maintaining a sufficient inventory of instruments.

• IUSS Survey Procedure• “If there is evidence to establish that the answer to any

of the following questions is “no” or the provider or supplier is using IUSS in a manner that places its patients at risk for infection, a citation under the appropriate infection control CoP/CfC is warranted.”

http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-44.pdf -accessed 9/3/2014

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CMS – Change in IUSS Terminology

• IUSS not an appropriate substitute for maintaining a sufficient inventory of instruments.

• IUSS survey procedure• Using IUSS in a manner that places patients at risk • No to any survey questions • Infection Control Citation

http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-44.pdf - accessed 12/21/2014

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Centers for Medicare and Medicaid Services

September 4, 2009 - CMS released a memo to state survey agency directors regarding sterilization practices.

“If manufacturers’ instructions are not followed, then the outcome of the sterilizer cycle is guesswork, and the ASC’s practices should be cited as a violation of 42 CFR416.44(b)(5).” (CMS, 2009)

http://www.ascquality.org/Library/sterilizationhighleveldisinfectiontoolkit/CMS%20Flash%20Sterilization%20Memorandum.pdf

25SHC ©

CMS – IUSS Survey Procedure• Used only emergently• Process in place to ensure:

• IUSS is not used for implants• IFUs are followed (instrument, sterilizer, container cleaning

supplies)• Sterilizers are maintained• Correct monitors are used, evaluated by trained personnel and

documented• Aseptically transported and cooled prior to use• Personnel are monitored for adherence to policy

http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-44.pdf -accessed 9/3/2014

26SHC ©

CMS Letter Endnotes• Association for the Advancement of Medical Instrumentation. Comprehensive

guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST 79:2010 &A1:2010 & A2:2011 & A3:2012&A4:2013 (consolidated text) www.aami.org

• AORN. Recommended practices for sterilization in the perioperative practice setting. Perioperative Standards and Recommended Practices. Denver, CO: AORN, 2014. www.aorn.org

• Centers for Disease Control (CDC). Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008.

• Seavey R. Immediate use steam sterilization: Moving beyond current policy. American Journal of Infection Control. 2013;41:S46-S48.

27

http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-44.pdf - accessed 12/21/2014

SHC ©

“Short cycle” confusion• American Society of Ophthalmic Administrators (ASOA)

released a public statement 2/15 titled, CMS Clarifies Policy to Permit Use of Short Cycle Steam Sterilization on Ophthalmic ASCs.

• Outpatient Surgery E-Weekly 2/10/15 states that based on the CMS clarification ACSs “can now breathe a sigh of relief” and that short cycle sterilization, as widely practiced in ambulatory ophthalmic centers, is now acceptable.

• 12 February 2015 Letter from AAMI to CMS - clarification – “short cycle” not defined.

28 ©

http://www.asoa.org/news/cms-clarifies-policy-permit-use-short-cycle-steam-sterilization-ophthalmic-ascshttp://www.outpatientsurgery.net/outpatient-surgery-news-and-trends/health-care-regulation/cms-clarifies-sterilization-guidelines-for-ophthalmic-ascs--e-02-10-15

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CMS 2/26/2015Sterilization of Ophthalmological Surgical

Instruments

• “Short cycle” – form of terminal sterilization • Wrapped/contained load• Pre-cleaning preformed according to manufacturer’s IFU• Load meets device manufacturers IFU – including complete

dry time• Packaged in a wrap or rigid container validated for later use.

29 ©

http://www.cms.gov/Outreach-and-Education/Outreach/FFSProvPartProg/Provider-Partnership-Email-Archive-Items/2015-02-26-eNews.html?DLPage=1&DLSort=0&DLSortDir=descending.

Calculating IUSS Rates?• No national benchmark

• Divide IUSS by number of procedures *

• Identify trends to determine:• Service• Types of instruments• Type of procedures• Specific surgeons• Time of day• Reason for IUSS

* Denholm, B. Clinical Issues: Calculating flash sterilization rates. AORN J. 2011:93 (2):296-297

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CDC Guide to Infection Prevention for Outpatient Settings

http://www.cdc.gov/HAI/pdfs/guidelines/Outpatient-Care-Guide-withChecklist.pdf

• Updated in 2014 to include the companion checklist

• Checklist useful to self-audit• IP regularly available? • Are appropriate P&P in place?• Do personnel follow correct

Infection Prevention practices?

Unacceptable Excuses• Not Following Standards and Guidelines

• Didn’t know about the standards/guidelines • Standards/guidelines not available to staff• Available but not current/up-to-date• No one designed as subject matter expert• Personnel are not trained on standards/guidelines etc. • Not enough personnel and/or time• Necessary equipment and tools not available

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Processing Policies & Procedures• Facility design and housekeeping, • Personnel – qualifications, training, and continuing education, • Dress code - PPE, • Sterilization monitoring,• Receiving purchased or borrowed items, • Loaner instrumentation (minimum 24 hour lead time)• Handling, collection, and transport of contaminated items, • Assembly, package configurations, and sterilization monitoring,• Processing endoscopes • Following manufacturer’s written IFU,• Maintenance and repair of medical devices, etc.

• Reference to current published standards• Not because it is a TJC or CMS standard!

33 SHC ©

Preparing for a Processing Audit• Accreditation Documents

• Relevant Professional Standards and Recommended Practices

• Accreditation Preparation Committee

Committee representatives should include:• Sterile Processing,• Operating room, • Infection prevention and control, • Clinical/biomedical engineering,• Endoscopy, • Risk management, • Quality,• Safety, • Education, • Administration, and• Materials management, etc.

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Surveys Preparation

• Self assessment• Subject Matter Experts

• Verify that each element of performance(EP) in each standard is addressed

• Front line staff involvement• Cite the EP (not just the standard)• Describe how that expectation is met

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Accreditation Preparation Resource Sterile Processing In Healthcare

Facilities: Preparing for Accreditation Surveys 2nd Ed.

• Hospitals • Ambulatory Care • Office-Based Surgery Practice • Current professional guidelines

• AORN, AAMI, SGNA, CDC• Current Accreditation standards

• CMS, TJC, AAAASF

http://www.aami.org/publications/books/sphc.htmlSeavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. 2014

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CrosswalkTJC Standards Linked to Current AAMI ST79

Crosswalk

http://www.aami.org/publications/books/sphc.htmlSeavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. 2014

37 SHC ©

TJC – Design Considerations • EC.01.01.01: The hospital plans

activities to minimize risks in the environment of care.

• EC.02.02.01: The hospital manages risks related to hazardous materials and waste.

• EC.02.04.01: The hospital manages medical equipment risks.

• IC.02.02.01: The organization reduces the risk of infections associated with medical equipment, devices, and supplies.

• LD.03.01.01: Leaders create and maintain a culture of safety and quality throughout the organization.

• LD.03.03.01: Leaders use hospital-wide planning to establish structures and processes that focus on safety and quality.

• LD.04.01.07: The organization has policies and procedures that guide and support patient care, treatment, or services.

• LD.04.01.11: The hospital makes space and equipment available as needed for the provision of care, treatment, and services.

• LD.04.04.07: The hospital considers clinical practice guidelines when designing or improving processes

Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. AAMI 2014. ANNEX G

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ST 79 Relative to TJC Design Considerations • Functional workflow patterns

(3.2.3)• Traffic control (3.2.4)• Electrical systems (3.3.3)• Steam for sterile processing

(3.3.4)• Steam quality (3.3.4.2)• Steam purity (3.3.4.3)

• Utility monitoring and alarm systems (3.3.5)

• General area requirements (3.3.6)• Ventilation (3.3.6.4)• Temperature (3.3.6.5)• Humidity (3.3.6.6)

• Special area requirements and restrictions (3.3.7)• Decontamination area

(3.3.7.1)• Preparation area (3.3.7.2)• Sterile storage (3.3.7.4)• Break-out area (3.3.7.8)• Emergency eyewash/shower

equipment (3.3.8)• Housekeeping (3.4)

Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. 2014. ANNEX G

39SHC ©

The Joint Commission (TJC)Standard IC.01.03.01 • The facility identifies risks for acquiring and

transmitting infections.

Element of Performance # 4• The facility reviews and identifies its risks at

least annually and whenever significant changes occur with input from, at a minimum, infection control personnel, medical staff, nursing, and leadership.

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Quality Process Improvement

• Addressing and reducing risks • Objective is to proactively identify the risks to reduce

the likelihood of a process failure.

• Risk Reduction Tools• Root Cause Analysis• Failure Modes and Effects Analysis (FMEA)• Tracers

• Risk Assessment can be your best friend in survey

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Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. AAMI 2014.

SHC ©

Common High-Risk Areas• IUSS • P&Ps not standardized • Loaner instrumentation • Torn wrappers • No IFUs• Sets weighing more than 25 pounds• Sterilization process failures• Inefficient staff orientation• No standardization• Lack of competency documentation

42SHC ©

Reference Articles• Risky business: Risk analysis in CSSD,

written by Sue KlacikPublished in Healthcare Purchasing News in August 2010http://www.hpnonline.com/ce/pdfs/1008cetest.pdf

• Are You Taking Risks When Cleaning Reusable Medical Devices?, written byMartha Young, BS, MS, CSPDTJanuary, 2013 In-service article archived athttp://www.3m.com/sterileu

Risk Analysis of the Sterilization Process Resources

Instruments Held Completely Open?

• Three facilities issued Immediate Jeopardy (IJ) by CMS

“All instruments must be held completely open with no tips touching.”“Stringers are not adequate to hold completely open.”

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Surveyor “Opinions” Cost Hospital• One faculty issued “IJ”

• 10 days to fix the problem• Purchased approximately 230 clamps at $30 each

($6,900)• Vendor questioned if the order was a mistake (8 to 10 is

normal)• Reprocessed every peel pack and instruments set

• Cost: packaging, sterilization costs, labor etc.? • Impact on surgery schedule…

45 SHC ©

Devices Used to Hold Open

46 SHC ©

What does AORN Say - Assembly?

IV.h. Items to be sterilized should be placed in thepackage or tray in an open or unlocked position.[3: Limited Evidence]

• The open or unlocked position facilitates sterilant contact of all surfaces of the item.

• IV.h.1. Racks or stringers designed and intended for sterilization can be used to maintain instruments in their open position.

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AORN - Guideline for Selection and Use of Packaging Systems for Sterilization 2015

SHC ©

What does AAMI ST79 say?8.4 Preparation and assembly of surgical instrumentation

8.4.1 General considerations...Instruments sets should be sterilized in perforated or wire-mesh-bottom trays, or in containment devices… with all instruments held open and unlocked.

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AAMI Current vs. Proposed Wording

Current edition ST798.4.4 Instrument placement

c) All jointed instruments should be in the open or unlocked position with ratchets not engaged. Racks, pins, stringers, or other specifically designed devices can be used to hold the instruments in the open position…

Proposed wording:• Ratcheted instruments should

be unlatched. Racks, pins, stringers, or other specifically designed devices

can be used to hold the instruments in the unlatched position

Does not state “jointed”, “open” or “unlocked” – just ratcheted” and “unlatched”

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Personal Opinions

• Surveys vary by state and surveyor– Do not be argumentative – Be assertive, not aggressive– Educate the surveyors on wording and interpretation – Have documents available that support your case and

how you meet the EPs.• Policies• Standards• Recommend Practices• IFU

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Unsubstantial or Personal Opinions?

• What reference is the surveyor basing their finding on?• Unlocked ratchet is what is meant by the statements in

AORN and AAMI.• Decontamination is where clamps need to be held

wide open.

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Another interpretation?

• CMS surveyor – CA• Peel packs for single item only!

Figure 8—Example of single- and double-packaging with paper–plastic pouches – Reprinted from ANSI/AAMI/ISO 14971:2007/(R)2010 with permission of Association for the Advancement of Medical Instrumentation, Inc. (C) 2007 AAMI www.aami.org. All rights reserved. Further reproduction or distribution prohibited

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Documentation a Hot Button• Air flow documentation• Daily temp and humidity logs• Logs for LMA reprocessing • Logs for phaco coaxial I/A tips limited usage• Instrument set weight logs• IUSS – how facility is decreasing (PI standards) • Premature release forms for implants, etc.• Loaners• Documentation standardized in all areas• Documentation of failed loads• Documenting the disinfection of brushes• Documentation of cleaning (AORN RP XIV)

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Improper Air Handling Self Assessment EC.02.05.01 EP 6 (Risk Element) 47%

• Identify all positive and negative locations • When was your last assessment?• What mechanism do staff have to routinely

monitor? – Tissue test– Electronic monitor with alarm– Ping pong ball in the wall

• Know when to notify facilities• Helps with compliance

– Pass through kept closed, etc.

April 2014 Patton Healthcare Consulting Newsletter

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Is This Proper Storage?

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Is this proper storage? Is this proper wrapping?

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Is This Proper Storage?

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Is This Proper Storage?

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More storage issues…

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Keep Doors and Windows Closed62SHC ©

Lack of Traffic Control in Restricted Areas

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65SHC © 66SHC ©

Deep cleaning…

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69SHC © 70SHC ©

71SHC © 72SHC ©

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No Separation of Clean and Dirty

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Separating Clean and Dirty – Splash GuardSHC © 74

• Tell a surveyor they are wrongTell them you don’t remember seeing that in the standard You had been following the community standard You will need to take that to your committee to make that policy change Ask which specific standard they are using

Never Ever

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• Be rude or disrespectful• Interrupt• Ask why they are asking something• Belittle a standard or regulation• Contradict something in your minutes• Suggest you have known of an issue for a

prolonged time and done nothing or stopped trying

Never Ever

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• Don’t volunteer to change practice (if they have no standard or evidence)

• Tell surveyor you see their point but politely and gently suggest you won’t be able to get it through the committee without more evidence

Strange Idea and No Evidence or Standard

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• Surveyors will cite you if you claim 100% sterilization documentation compliance and they see violations

• More willing to ignore if you say you are working on it

Never claim perfection!

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• Know every document you give them• Know everyone they spoke with and what they said

• Know what questions are being asked• Share this with staff

• Know where your deficiencies are and fix if possible before they leave (more apt to change a citing)

Other Survey Hints

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Summary of Suggestions

• Be proud of your facility • Make a good first impression• Treat surveyor as if they are

there to help you• Be assertive but have your

“ducks in a row”

• Write policies referenced to standards/guidelines

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Document and Display Your Success Stories• Story boards for process improvement (PI) initiatives

• IUSS: Show process improvements (benchmark against self)

• Standardization• Loaned instruments• IFUs readily available• Certification …”demonstrated knowledge” framed

photos

• Constant and consistent preparation for an accreditation!

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The Final Word… Risk reduction and process improvement

are the heart and soul of surveys.

Thank you

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References • Guidelines for Sterilization. In: Guidelines for Perioperative Practice. Denver, CO:

AORN, Inc; 2015

• Guidelines for Cleaning and Care of Surgical Instruments, In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc; 2015.

• ST79 - Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013

• Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. 2014.

• Eiland, John E, Surveyor, The Joint Commission. Joint Commission presentation at IAHCSMM annual meeting in May 2013. Presentation available on flash drive provided to attendees.

• Kuhny, Louise. The Joint Commission Standards and Survey Process. AORN webinar 9/22/2011. To order access at: http://www.aorn.com/Secondary.aspx?id=21189&terms=Webinars#axzz20596Ipvv

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References • CMS Director of Survey and Certification Group memo to State Survey Directors on

Flash Sterilization Clarification-FY 2010 Ambulatory Surgical Center (ASC) surveys, September 4, 2009. Accessed 7/8/2012 at: http://www.cms.gov/SurveyCertificationGenInfo/downloads/SCLetter09_55.pdf

• Office of Clinical Standards & Quality/Survey & Certification to State Survey Agency Directors on CMS Survey & Certification Focus on Patient Safety and Quality-Draft surveyor Worksheets, Oct 14, 2011. Accessed 7/8/2012 at: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/downloads/SCLetter12_01.pdf

• Office of Clinical Standards & Quality/Survey & Certification to State Survey Agency Directors on Patient Safety Initiative Pilot Phase-Revised Draft Surveyor Worksheets on May 18, 2011. Accessed 7/8/2012 at: http://www.apic.org/Resource_/TinyMce

• Policy and Requirements for an Application for Deeming Authority. Accessed 7/12/2012 at: http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/downloads//applicationrequirements.pdf

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Questions?

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