Going for Gold – The Bridge to Patient Care

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Going for Gold – The Bridge to Patient Care

Stacy Olea, MBA, MT(ASCP), FACHE

Field Director

Delaware Valley Chapter CLMA Annual Fall Meeting

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Objectives

Learn about The Joint Commission Laboratory standards

Explain the unique features of a Joint Commission Laboratory survey

Understand what to expect during your survey Learn what happens after the survey has been

completed Review how to use the available tools to assist you

with continuous compliance Present suggestions on how to resolve the top 10

findings

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The Joint Commission’s Vision

All people experience the safest, highest quality, best-value health care across all settings.

The Joint Commission’s MissionTo continuously improve health care for the public, in collaboration with other stakeholders, by evaluating health care organizations and inspiring them to excel

in providing safe and effective care of the highest quality and value.


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Reasons Organizations do not use The Joint Commission for Laboratory Accreditation

Employed Surveyor Cadre Did not know The Joint Commission offered a

laboratory program The Joint Commission does not have standards in

Forensic Drug testing No checklist Thought the laboratory surveyors where physicians

and nurses


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Reasons Organization use The Joint Commission for Laboratory

Accreditation Largest and oldest organization dedicated to survey process and risk

evaluation for over 19,000 health care organizations

Professional surveyor cadre

Tracer methodology and system evaluation

Lab Advantage combined services option (PT, CE, and accreditation)

Organizational alignment for operational synergy

Cost is based on volume

More than one way to meet the standards

Annual procedure review can be done by signing one cover sheet

Ability to detect risks that were unknown prior to the visit

Onsite visit activities and findings added value to improving the quality of healthcare

Collaborative approach


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Accreditation StandardsComprehensive

Accreditation Manual for Laboratory and Point-of-Care Testing (CAMLAB)– Free print copy– Electronic copy via E-dition

Focus on high quality, safe laboratory services– Expectations for performance – reasonable,

achievable, surveyable– CMS recognizes Joint Commission accreditation

as meeting CLIA requirements


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Accreditation Standards

Surveyors use standards for evaluation– Patient tracer methodology– Follow samples from collection to result

reporting

Organization-wide processes– Valuable component of a complex delivery

system– Not an isolated department


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Broad vs. Prescriptive Requirements

Broad– Processes (means

to an end)– Many ways to

accomplish goals– Processes designed

by Organizations– Remains valid with

changing science

Prescriptive– Specific requirements

(specific outcome)– The only way– Evidence-Based– Readjustments are

required with changing science


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Unique Issues with LaboratoryOften uses prescriptive

requirements– CLIA requirements– Industry convention

Avoid prescriptive requirements– Multiple effective methods may exist– Could stifle emerging practices– Tracers are a system review process

(rather than task verification)– Allows standards to be nimble


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Subject matter expert participation

Laboratory PTAC review– Comprised of members from industry association

stakeholders

National Field Review– 6 week public comment period

Board Committee (SSP) approves

6-month notification to allow preparation

Standards Development Process


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New standards timeline (12-18 months)– Research, revisions– Public comment, pilot testing

CAMLAB updated (6 months)– Standards updates– Front matter/resource edits

Standards Development Process


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Layout of CAMLAB

Front Matter– How to Use this Manual

13 Chapters– Shared Chapters– Unique Chapters

Resources– Glossary– Standards Applicability Grid


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Standards Chapters

Chapters Unique to CAMLABDC - Document and Process Control

specimen collection, test orders, test procedures, reporting, record retention

QSA – Quality System Assessment for Nonwaived Testingproficiency testing quality control, standards for specialties and subspecialties


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Standards Chapters Chapters Shared with Other Programs

EC – Environment of Carephysical environment, equipment, hazardous materials/waste, fire safety, utilities

HR – Human Resourcesstaff qualifications, orientation, training, competence, performance

LD – Leadershipstructure, relationships, organizational culture, operations

NPSG – National Patient Safety Goalstwo patient identifiers, reporting critical results, hand hygiene


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Anatomy of a Standard

StandardIdentifies a goal (i.e., participation in proficiency testing)

Rationale/IntroductionExplains why it is important to achieve the goalProvides background information for requirement

Element of Performance (EP)Outlines the steps needed to achieve the goalExpectations for compliance


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Not all requirements apply to all specialties– Based on services provided by your laboratory– Specialties listed horizontally, standards vertically

Standards Applicability Grid


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Scoring Scoring Process

– Category A EPs: relate to structural requirement– Category C EPs: frequency based that are scored based on

the number of times an organization is found not to be compliant

– Performance expectation– Score 2 = Satisfactory compliance– Score 1 = Partial compliance– Score 0 = Insufficient compliance

– Track record achievements at the time of survey– Score 2 = 24 month– Score 1 = 6 to 23 months– Score 0 = Fewer than 6 months


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Accreditation Decision

How accreditation decisions are made– Criticality model– The more immediate the risk the shorter

the period of time given to address noncompliance

– All partially compliant and insufficiently compliant EPs must be addressed


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What is unique to our survey process?

Employed surveyor cadrePriority Focus ProcessConcentration on the operational

systems that directly affect the quality and safety of diagnostic services

National Patient Safety GoalsTracer Methodology


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Employed Surveyor Cadre

Effective evaluators

– Process is thorough, fair, and objective

– Process identifies most critical safety and quality issues

– Process is inclusive of mandatory (regulatory) and collaborative (inspirational) modes

– Process is continuous, not event driven

– Process is guided by surveyor experience and expertise, informed by data

– Process looks at systems and integration, not a list of tasks

All have clinical laboratory management experience

A full time surveyor will evaluate approximately 60 laboratories a year

Anatomical pathologist surveyors are available upon request

Surveyor continual training and performance monitoring


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Priority Focus Process

Data driven tool that provides surveyors with pre-survey information that has been developed using a standardized methodology

Helps surveyors evaluate health care organizations’ performance more consistently

Helps to focus the surveyors’ assessment on quality and safety issues specific to an individual laboratory

Sources used includes The Joint Commission, the laboratory and other public sources

PFP reports are posted to your extranet site quarterly and as changes warrant– The top four-to-five priority focus areas– The clinical/service groups


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Operational Systems Approach

Our mission and vision drives us to look at how the laboratory is integrated into patient care

We will spend time outside of the laboratory– Nonwaived ancillary Point of Care Testing sites

(cardiac cath labs, ORs)– A sampling of waived and PPMP Point of Care

Testing sites– Transfusion administration and management– Perioperative Transfusion Services– Tissue storage and management– Hospital Integration


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NPSG.01.01.01

Use at least two patient identifiers when providing laboratory services.

EP1 - Use at least two patient identifiers when administering blood or blood components; when collecting blood samples and other specimens for clinical testing; and when providing other treatments or procedures. The patient’s room number or physical location is not used as an identifier.

EP2 - Label containers used for blood and other specimens in the presence of the patient.


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NPSG.02.03.01

Report critical results of tests and diagnostic procedures on a timely basis.

EP1 - Collaborate with organization leaders to develop written procedures for managing the critical results of tests and diagnostic procedures that address the following:

– The definition of critical results of tests and diagnostic procedures

– By whom and to whom critical results of tests and diagnostic procedures are reported

– The acceptable length of time between the availability and reporting of critical results of tests and diagnostic procedures

EP2 - Implement the procedures for managing the critical results of tests and diagnostic procedures.

EP3 - Evaluate the timeliness of reporting the critical results of tests and diagnostic procedures.


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NPSG.07.01.07

Comply with either the current Centers or Disease Control an Prevention (CDC) hand hygiene guidelines or the current World Health Organization (WHO) hand hygiene guidelines.

EP1 - Implement a program that follows categories IA, IB, and IC of either the current CDC or WHO hand hygiene guidelines.

EP2 - Set goals for improving compliance with hand hygiene guidelines.

EP3 - Improve compliance with hand hygiene guidelines based on established goals.


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Tracer Methodology

Uses actual patients as the framework for assessing standards compliance

Individual tracers follow the experience of care through the entire health care process in the organization

System tracers evaluate the integration of related processes– Coordination and communication among disciplines and

departments– In-depth discussion and education regarding the use of

data in performance improvement

Reference document available at http://www.jointcommission.org/tracer_methodology_101/


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Tracer Methodology Common starting points for tracers

– Sample Collection

– Critical results

– Transfusion Medicine

– Point of Care Testing

– Frozen Sections

Documents reviewed during tracers

– Order

– Instrument maintenance records, calibration verification, quality control

– Policies and Procedures

– Employee competency

– Blood Utilization Review

– Process Improvement

– Patient Medical Records

Staff interviews and Direct Observations


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Joint Commission Survey Options

Pathologist Corporate Surveys

– Dedicated Team– Orientation to your Organization– Annual Summation

Simultaneous Surveys– Other Programs– Sister facilities

Concurrent Surveys


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On-Site Survey Activities

Surveyor photo, bio and survey agenda are posted to the extranet site at 07:30 local time (mobile app)

Depending on the complexity of the organization a survey may last more than one day and could involve a team of surveyors

Once the surveyor arrives, the organization’s extranet must be checked for confirmation of the survey and identification of the surveyor

Preliminary Planning Session Opening Conference Orientation to the Organization


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On-Site Survey Activities

A Daily Briefing occurs every morning of a multiday survey, with the exception of the first day

Competency Assessment Personnel education/qualification verification Regulatory Review Proficiency Testing Validation/Performance

Improvement Data Review Individual Tracers Physical Environment Survey Report Preparation CEO Exit Briefing and Organization Exit Conference


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Required Documentation

Documentation list for your survey– The 24 month reference in the following

items is not applicable to initial surveys, except for proficiency testing data.

– For initial surveys, a minimum of 4 months of data must be available for review.


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As a laboratory, you should have the following information and documents available for the surveyor to review during the Surveyor Planning Session

– Name of key contact person who can assist in planning tracer selections

– CLIA Certificates, Specialties and Subspecialties, State Licenses, and personnel license or certification if required by the state or organization policy

– An organizational chart and map of the facility

– Ability to retrieve testing records for patients who have had laboratory tests or other services for the past 24 months (4 months if an initial survey)

– Performance improvement Data for the past 24 months (4 months if an initial survey)

– Proficiency data by CLIA number for the past 24 months


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As a laboratory, you should have the following information and documents available for the surveyor to review during the Surveyor Planning Session– Results of periodic laboratory environment inspections from the safety

committee or safety officer

– Manifests for the disposal of hazardous waste for the past 24 months (4 months if an initial survey)

– A list of specialties and subspecialties performed by the lab

– A list of tests performed (test menu) and instruments used including all ancillary and point of care sites

– Measures of Success (MOS) identified in the Plan of Action from the Periodic Performance Review

– Employee personnel files will be reviewed, including employee education records, competency documentation, and employee health information

– Note: Surveyors may need to see additional documents throughout the survey to further explore or validate observations or discussions with staff.


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From Survey Report to Accreditation Decision

A preliminary report is available on the extranet until midnight of the day the survey has been completed.

The accreditation decision is not made until all of your organization’s post-survey activities are completed

The final summary of survey findings report will be posted on your extranet site.– It will include which findings require an Evidence of

Standards Compliance (ESC) submission within 45 days (direct impact standards) and/or 60 days (indirect impact standards)

Upon approval of your organization’s last submitted ESC, your accreditation decision is posted to your extranet site and to Quality Check (www.qualitycheck.org)


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Standards Clarification

Organizations have the opportunity to submit a clarifying ESC if they believe that their organization was in compliance with a standard at the time of the survey

The clarification must be submitted within 10 business day following the posting of the organization’s report to the extranet.

When submitting clarifying ESCs after a survey event, it is important to follow the directions in the submission tool. You need to address the EP as well as the actual surveyor observation.

The submission of a clarification does not negate the requirement for submission of a corrective ESC within 45 or 60 days if the RFI continues, nor does it provide an organization with additional time to submit its ESC.


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Corrective ESC

An acceptable corrective ESC report must detail the following:– Action(s) that the organization took to bring itself into compliance

with a standard

– The title of the person(s) responsible for implementing the corrective actions or approving a revised policy, procedure, or process

– Compliance at the EP level and include a Measure of Success (MOS) if applicable

There may be times when an ESC will also be conducted on site by a surveyor– Provides the opportunity to evaluate the organization’s success in

correcting issues

– Allows the surveyor to provide coaching and guidance to the organization supporting its efforts to achieve and maintain compliance


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Measure of Success (MOS)

A numerical or quantifiable measure, usually related to an audit to determine if action was effective and sustained

Due four months after notification of an acceptable ESC

Not required for all ESCs


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Help us improve the survey process

Customer Value Assessment– Before the survey happens– Allows you to set expectations– After the survey is over to evaluation our performance

HCO Evaluation– Your opportunity to provide us with feedback on the survey

process and the surveyor(s)– Exceed Expectations, Meets Expectations, Below

Expectations, Not Observed– 14 questions with room for comments– Additional line to enter your information if you want

someone from The Joint Commission to contact you

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Accessing Standards Via E-dition


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Standards Interpretation Group (SIG)

Phone:

630-792-5900 Option 6

Online:http://www.jointcommission.org/Standards/OnlineQuestionForm/

FAQs:http://www.jointcommission.org/Standards/FAQs

http://www.jointcommission.org/Standards/OnlineQuestionForm/

http://www.jointcommission.org/Standards/FAQs


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Intracycle Monitoring

Located on your Joint Commission extranet site

Required on your off cycle year and can be accessed before your first survey

Three options availableOpportunity to ask questions and develop

plans of action in a non-punitive manner


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Leading Practice Library

Opened to all of our accredited organizations

Database to formally identify and share leading practices (including case studies, white papers, tools, policies, etc.) which reflect excellent compliance with Joint Commission standards and National Patient Safety Goals.

Sort by program


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Center for Transforming Healthcare

Formed in 2009 to find solutions to pressing health care issues identified by CEOs

Uses DMAIC principles to analyze and identify root causes which vary by institution– One size does not fit all for persistent issues!

Projects include:– Hand hygiene

– Hand off communications

– Wrong Site surgery

– Surgical Site infections (with ACS)

– Safety Culture

Solutions database available from Joint Commission to enter your own data and perform your own project to improve care


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Lab Central

New customer portal that improves accreditation:– Allows organizations to organize files in one place

to make surveys more efficient– Surveyors can review data before the survey to

get better snapshot of organization– Data available for ICM discussion with SIG– Provides a place for private document

management

Mandatory use starting January 1, 2013


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From Accreditation to Continuous Compliance

Concentrate on incorporating the frameworks and concepts of standards and EPs into day-to-day work rather than viewing the concepts as rules that must be followed

Read Perspectives each month to identify new/updated standards, scoring, standards interpretation

Sign up for E-Alerts Complete your intracycle monitoring Contact SIG to submit standard questions Enter your information into Lab Central


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Resources and Tools Resources and Tools available

– CAMLAB

– Perspectives monthly publication

– Joint Commission Center for Transforming Healthcare

– Account Executive

– Joint Commission extranet site– Leading Practice Library

– BoosterPaks

– E-dition web-based manual

– Lab Central

– Joint Commission webpage– CLSI crosswalk

– Standards’ Frequently Asked Questions

– Tracer Methodology 101 article

– Sign up for E-Alerts

– Lab Focus

– Free audio conferences


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Resources on the Web

Centers for Medicare & Medicaid Services (CMS)CLIA: www.cms.hhs.gov/cliaCOPs: www.cms.hhs.gov/CFCsAndCOPs/

Centers for Disease Control and Prevention (CDC) www.phppo.cdc.gov/clia

Food and Drug Administration CLIA Database Searchwww.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Search.cfm

CLSI-Joint Commission Crosswalk

http://www.clsi.org/Content/NavigationMenu/Resources/TJC_CrosswalkWEB.pdf

http://www.cms.hhs.gov/clia

http://www.cms.hhs.gov/CFCsAndCOPs/

http://www.phppo.cdc.gov/clia

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Search.cfm




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Top 10 Findings

Top 10 Initial Survey Findings

– DC.02.03.01 EP2– WT.05.01.01 EP3– QSA.02.03.01 EP3– QSA.02.08.01 EP2– WT.05.01.01 EP4– QSA.01.01.01 EP5– QSA.02.04.01 EP6– NPSG.02.03.01 EP3– DC.02.01.01 EP1– QSA.01.02.01 EP2

Top 10 Overall Survey Findings

– QSA 01.01.01 EP5– QSA.02.03.01 EP3– WT.01.01.01 EP3– QSA.02.08.01 EP2– QSA.01.02.01 EP2– DC.02.03.01 EP2– QSA.01.01.01 EP6– QSA.02.04.01 EP6– QSA.02.04.01 EP7– WT.03.01.01 EP5


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Initial and Overall Top 10

DC.02.03.01 The laboratory report is complete and is in the patient’s clinical record. EP2 - The laboratory report includes the name and address of the laboratory performing the test.

QSA.02.03.01 The laboratory performs calibration verification. EP3 – Calibration verification is performed every six months. See CAMLAB for additional Notes.

QSA.02.08.01 The laboratory performs correlations to evaluate the results of the same test performed with different methodologies or instruments or at different locations. EP2 – The laboratory performs correlations at least once every six months. The correlations are documented.

https://www.beckmancoulter.com/wsrportal/wsr/diagnostics/clinical-products/hematology/unicel-dxh-800-coulter-cellular-analysis-system/index.htm


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QSA.01.01.01 The laboratory participates in Centers for Medicare & Medicaid Services (CMS) approved proficiency testing programs for all regulated analytes. EP5 – For each specialty, subspecialty, analyte, or test, the laboratory’s proficiency testing results meet satisfactory performance criteria in accordance with law and regulation. See CAMLAB for additional Notes.

QSA.02.04.01 The laboratory evaluates instrument-based testing with electronic or internal systems prior to using them for routine quality control. EP6 – The laboratory performs external quality controls at the following frequencies:

– As defined by the evaluation (either weekly or monthly)

– According to the manufacturer’s recommendations

– With each new lot number, shipment, or package of reagents

The external quality control results are documented.


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QSA.01.02.01 The laboratory maintains records of its participation in a proficiency testing program. EP2 – For individual unacceptable proficiency testing results, the laboratory conducts an investigation of all potential causes, provides evidence of review, and performs corrective action sufficient to address and correct the issues identified in the investigation. These actions are documented. See CAMLAB for additional Notes.


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Initial Top 10

WT.05.01.01 The organization maintains records for waived testing.

– EP3 – Quantitative test result reports in the patient’s clinical record for waived testing are accompanied by reference intervals (normal values) specific to the test method used and the population served. See CAMLAB for additional Notes.

– EP4 – Individual test results for waived testing are associated with quality control results and instrument records. See CAMLAB for additional Notes.

NPSG.02.03.01 Report critical results of tests and diagnostic procedures on a timely basis. EP3 – Evaluate the timeliness of reporting the critical results of tests and diagnostic procedures.


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Initial Top 10

DC.02.01.01 The laboratory has procedures for each laboratory test. EP1 – Written laboratory procedures for each test meet the following requirements:– They contain a complete description of the test.– They include detailed instructions for performing the test.– They adhere to manufacturers’ instructions (preanalytical,

analytical, and postanalytical phases of testing).– They include the date of implementation.– They reflect the laboratory’s current practice.– They are readily available to staff performing the testing.

See CAMLAB for additional Notes.


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Overall Top 10

WT.01.01.01 Polices and procedures for waived tests are established, current, approved, and readily available. EP3 – If manufacturers’ manuals or package inserts are used as the policies or procedures for each waived test, they are enhanced to include specific operational policies (that is, detailed quality control protocols and any other institution specific procedures regarding the test or instrument).

QSA.01.01.01 The laboratory participates in Centers for Medicare & Medicaid Services (CMS) approved proficiency testing programs for all regulated analytes. EP6 – The laboratory’s proficiency test performance is successful for each specialty, subspecialty, analyte, or test, as required by law and regulation. See CAMLAB for additional Notes.


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Overall Top 10

QSA.02.04.01 The laboratory evaluates instrument-based testing with electronic or internal systems prior to using them for routine quality control. EP7 – The laboratory performs external quality controls at the number of levels specified by the specialty and subspecialty requirements (for example, blood gases require three levels of quality control). The external quality control results are documented.

WT.03.01.01 Staff and licensed independent practitioners performing waived tests are competent. EP5 – Competency for waived testing is assessed using at least two of the following methods per person per test:

– Performance of a test on a blind specimen

– Periodic observation of routine work by the supervisor or qualified designee

– Monitoring of each user’s quality control performance

– Use of a written test specific to the test assessed


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Objectives

Learn about The Joint Commission Laboratory standards

Explain the unique features of a Joint Commission Laboratory survey

Understand what to expect during your survey Learn what happens after the survey has been

completed Review how to use the available tools to assist you

with continuous compliance Present suggestions on how to resolve the top 10

findings


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Demonstration of the Extranet and The Joint Commission

Webpage