today’s featured speaker - point of care. · pdf filestandards interpretation group at...

Point-of-Care Testing, Sep. 2009 – Pg. 1

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Today’s Featured Speaker

Megan E. Sawchuk, MT (ASCP) Megan Sawchuk is an associate director in the Standards Interpretation Group at The Joint Commission. In this role, she conducts Periodic Performance Reviews and provides interpretation of all Joint Commission standards with a special emphasis on clinical laboratory and point-of-care standards.

Megan also serves as an internal consultant to other Joint Commission departments in the development and revision of standards and survey process, complaint review, and providing support for ongoing accreditation services and special projects.


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Point-of-Care Testing: Putting Together the Accreditation Puzzle

September 16, 2009Bay State Webinar

Megan E. Sawchuk, MT(ASCP)Associate DirectorStandards Interpretation Group


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Objectives

Learn which Joint Commission standards apply to your POCT program

Understand the competency requirements for waived, PPMP, and non-waived testing

Review common POCT compliance challenges


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Which standards apply to POCT?

Sources of confusion – Definition of a lab test regulated by

CLIA– Exceptions– Multiple test complexity levels– Multiple laboratory accreditors– Multiple healthcare accreditation

programs, e.g. hospital, ambulatory, lab


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Definition of a lab test

Laboratory test = in vitro testing on blood, body fluids, or tissue performed for– Diagnosis – Treatment– General assessment of health

Regulated by CMS’ Clinical Laboratories Improvement Amendments (CLIA) [42 CFR 493]

– HAP/AMB have Conditions Of Participation (CoPs)


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Standards Applicability & Exceptions

Applies to most healthcare testing, including employee health testing

Exceptions defined in law – Research (the test itself)

–Clinical research is regulated, e.g. drug trials in which CBCs are conducted.

– Forensic testing (legal use)– Employee drug testing


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Exceptions based on definition

NOT considered laboratory testing– Breath alcohol – Continuous glucose monitors (glucose “watch”)– Pulse oximeters– Transcutaneous bilirubinometers– Ex vivo ABG & electrolyte (VIA LVM)

Biosensor Technologies (monitors)Survey under equipment management plan, not Waived TestingFAQ on website


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Biosensor Technology FAQ


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Test Complexity

Tests approved by FDA - assign test complexity– Waived

– CLIA waived does NOT mean CLIA exempt – FDA cleared does NOT mean CLIA waived

– Moderate – Includes Provider Performed Microscopy

– High Test complexity determines requirements for personnel,

Quality Control (QC), and inspection/accreditation


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Point-of-Care Tests (POCT)

Waived tests– Glucose meters– Urinalysis strips– Occult blood– Rapid strep

screens– HemoCue– Coagucheck

PPMP– Fern– KOH– Wet Prep– Urine Microscopic

Non-waived– iSTAT– ABG analyzers– ACT analyzers– TEG– Mohs Testing


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CLIA Certificate

Must have correct CLIA certificate for testing level CLIA certificates commonly held in TJC accredited

facilities:– Certificate of Waiver (CoW)– Provider Performed Microscopy Procedures (PPMP)– Certificate of Registration (CoR) (Moderate & high = non-

waived; Initial certificate for new lab)– Certificate of Accreditation (CoA) (Moderate & high = non-

waived; certificate after survey from accreditor, e.g. TJC)

Other CLIA certificate types (N/A to TJC accredited)– Certificate of Compliance (CoC) (Moderate & high = non-

waived; certificate after lab has been state inspected)


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Laws and Policies

Law – All nonwaived CLIA certificates must be inspected every two years– No federal requirement for inspection of WT or PPMP,

therefore, no accreditation award for them TJC policy - All components of a Joint

Commission accredited organization must be accredited by ourselves or a cooperative partner– The Joint Commission Laboratory Accreditation Program– College of American Pathologists (CAP)– Commission on Office Lab Acc. (COLA)– State of Washington


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Which standards apply to POCT?

First questions to ask:– Who accredits the main laboratory?– Who accredits the non-waived ancillary

laboratory services?– Point of care

– Nursing units– Blood gases– Clinics

– Who accredits the organization?


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How do I know which lab services are accredited by TJC, if any? Obtaining accreditation means the organization

has submitted a laboratory application with The Joint Commission and has a survey every two years led by an MT/CLS surveyor

– Only non-waived services can be accredited– Could be main lab, POCT only, or both– Organization could have more than one laboratory

accreditor, e.g. main lab CAP, POCT TJC Note that having TJC accredit the hospital does

not mean your laboratory services are TJC accredited

– Survey every three years– Team of RN, MD, LSC, Administrator– No technical elements of testing are reviewed


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If there are non-waived laboratory services accredited by TJC: Laboratory standards manual applies

– Surveyed every two years– Refer to Appendix A for POCT and POL standards listing– Waived testing: APRs, NPSGs, LD.04.01.01, WT

chapters apply– Nonwaived testing: All chapters apply, except WT

– Quality Control – 3 sections– Proficiency testing – all apply (QC.1.20 –

QC.1.40)– Systems standards – all apply (QC.1.60 –

QC.1.50)– Specialty & subspecialty – specific groups apply

(e.g. QC.6.10 – QC.6.50 for chemistry)


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If there are non-waived laboratory services accredited by TJC (continued):

– Nonwaived testing: All chapters apply, except WT– Many standards are “core” HAP/LAB requirements

that can be met with organizational policies– Accreditation Participation Requirements (APR)– National Patient Safety Goals (NPSG)– Performance Improvement (PI)– Leadership (LD)– Environment of Care (EC) – Human Resources (HR)– Information Management (IM)– Infection Control (IC)


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If there are non-waived laboratory services accredited by TJC (continued):

Also surveyed: – Tissue Storage & Issuance– Clinical transfusion practices– Perioperative transfusion

services


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Are there TJC organizational standards that apply to POCT? Yes. The organization has a separate standards manual

from that of the laboratory, The organization standards manual applies, e.g. hospital,

ambulatory, behavioral health, office based surgery, long term care, home care

– Standards same across all other Joint Commission accreditation programs (except Critical Access Hospital, which defaults to CLIA regulations)

– Surveyed every three years– Primarily only waived testing: APRs, NPSGs, LD.04.01.01, WT

chapters apply– Nonwaived: Other standards could be reviewed, e.g. safety,

infection control, inventory management, specimen collection & transport, clinical side of transfusion medicine, tissue storage and issuance

– No technical testing requirements would be surveyed


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But what does it all mean?


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Organization is TJC accredited, but NONE of the non-waived lab services

Laboratory should follow:– Their laboratory accreditor’s requirements, e.g.

CAP or COLA (surveyed every two years)– TJC organizational standards, primarily the

waived testing requirements (surveyed every three years)

– For waived testing, organizations must follow the most stringent requirements when standards vary between accreditors.

TJC Laboratory standards manual does not apply


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Organization & SOME of the non-waived laboratory services are TJC Accredited:

Laboratory should follow:– TJC laboratory standards for services in which the

organization applied, waived testing, tissue, and clinical side of transfusion if there is no blood bank (surveyed every two years)

– The other laboratory accreditor’s requirements (CAP or COLA) for the services in which they applied for accreditation (surveyed every two years)

– TJC organizational standards, primarily the waived testing requirements (surveyed every three years)

– For waived testing, organizations must follow the most stringent requirements when standards vary between accreditors.


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Organization & ALL of the non-waived laboratory services are TJC Accredited:

TJC Laboratory standards (surveyed every two years)

TJC organizational standards (surveyed every three years)

Volunteers currently evaluating the opportunity for concurrent organization and laboratory survey every six years (every other organizational survey)


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Complex scenario 300 bed hospital

– Joint Commission accredits hospital– Joint Commission accredits non-waived lab services for blood

gas lab, POCT, and ancillary clinics– Main laboratory is accredited by a cooperative partner

What happens? – Every three years, TJC hospital team surveys waived testing – Every two years, TJC lab surveyor reviews blood gas, POCT

and ancillary sites, as well as tissue and clinical transfusion– Every two years (may be different cycle), 2nd lab accreditor

surveys main laboratory Why does the hospital team review waived testing?

– Waived POCT testing is not required to be accredited. Services outside the main laboratory are not routinely reviewed by the cooperative partners. Thus, if an organization does not have TJC lab accreditation, waived testing may never be surveyed.


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When should we participate in the Periodic Performance Review?

PPR Software– Web enabled tool via secure extranet– Self-assessment—non-punitive process– Submitted annually– Plans of Action / Measures of Success

Conference Call (Optional)– Standards Interpretation Staff (SIG)– Approval of POA and MOS


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Completing the PPR if your laboratory services are accredited:

Only by The Joint Commission– Complete review against all applicable standards in lab manual– Participate in the hospital’s PPR and the WT standards

Only by a Cooperative Partner– Participate in the partner’s self assessment process– Participate in the hospital’s PPR and the WT standards

By a combination of laboratory accreditors– Complete review of all applicable standards in the lab PPR for

those services that are Joint Commission accredited– Participate in the partner’s self assessment process– Participate in the hospital’s PPR and the WT standards


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E-dition of the standards

Profile for your laboratory and organization will be built from your application

Only the applicable standards will be displayed– Organizational Customized Standards (OCS)


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What is required for POCT competency assessments?


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Competency

Content and frequency varies by test complexity Nonwaived (HR.2.10 and HR.3.10)

– Frequency: Initial, at six months, then annually thereafter (0, 6, 12, 24, 36, etc.)

– Also when methods change– Content: Must use all 6 methods (CLIA defined)

– Blind testing– Direct observation of routine testing – Monitoring QC performance (by each user)– Written testing– Direct observation of instrument checks– Monitoring result reporting

– Signatures: Both the director/supervisor and the employee must sign that the individual has received training and is competent prior to performing testing independently


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Competency

Frequency and content vary by test complexity Waived (WT.1.30 or WT.03.01.01)

– Frequency: Initial and then annual– Content: Must use 2 of 4 specific methods

– Blind testing– Direct observation of routine work – Monitoring QC performance (by each user)– Written testing

– Signatures: Only the director/supervisor must sign that the individual has received training and is competent prior to performing testing independently


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What are some of the common POCT challenges?


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Common POCT challenges

Non-waived testing– Equivalent Quality Control (EQC) impacts other

requirements– Issues

– Validations, esp. if multiple meters– External QC conducted for every CLIA– External QC should be done by testing personnel– Proficiency testing performed by testing personnel

– Common instruments– ACTs– i-STAT– ABG instruments

– Dual complexity devices– Reportable range limited by QC material


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Equivalent QC / Alternative QC

Traditional QC uses external liquid controls Equivalent QC (EQC) may use electronic or internal

controls, e.g. simulators, control dots Also known as Alternative QC (AQC), to differentiate

from Electronic QC If the system simulates two levels of controls, it can

be used to meet Joint Commission daily QC requirements for both waived and non-waived testing

Electronic “checks” are not sufficient


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Non-waived testing (QC.1.77)– Option I

– QC monitors the entire analytical process– 10 day parallel validation of traditional external QC

against the internal QC– Reduced external QC frequency to at least once per

month and per lot and shipment– Option II

– QC monitors the entire analytical process– 30 day parallel validation of traditional external QC

against the internal QC– Reduced external QC frequency to at least once per

week and per lot and shipment


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Non-waived testing– Traditional external QC at reduced frequency

– 2 levels for most analytes– 3 levels for ABGs (per QC.6.20)

For waived testing, we encourage use of a validation process and reduced traditional QC frequency, but it is not expressly required by the standards


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Common POCT challenges

Waived testing– QC frequency– EQC/AQC– PT/INR systems with no external

QC– Manufacturer suggestions and

recommendations– Documentation


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Potential for falsely elevated blood glucose results with certain glucose methods on patients who are receiving therapeutic products containing certain non-glucose sugars

– May mask significant hypoglycemia– Or prompt excessive insulin administration

6 fatalities in 2008 (13 total since 1997) http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/Public

HealthNotifications/ucm176992.htm

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm176992.htm�

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm176992.htm�


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Comparison of Requirements

Joint Commission Requirement Nonwaived Waived

CLIA certificateYes

Certificate of Accreditation (COA)

YesCertificate of Waiver

(COW)

Establish P&P Yes Yes

Initial training and annual competency

YesSemiannual in 1st year

Yes

2 levels of QC each day Yes3 for ABGs

Yes

Reference intervals on patient chart Yes Yes

Quantitative results

Critical value reporting Yes Yes


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Comparison of Requirements

Joint Commission Requirement Nonwaived Waived

Method validation Yes No

Equivalent QC (EQC) validation Yes No

Semiannual correlation studies Yes No

Semiannual calibration verification Yes No

Proficiency testing 3x/year Yes No


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Web Sites

Centers for Medicare and Medicaid Services (CMS)www.cms.hhs.gov/clia

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

Food and Drug Administration (FDA)www.fda.gov/cdrh/clia

The Joint Commission’s Frequently Asked Questions (FAQs)

www.jointcommission.org

http://www.cms.hhs.gov/clia�

http://www.phppo.cdc.gov/clia�

http://www.fda.gov/cdrh/clia�

http://www.jointcommission.org/�


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Contact The Joint Commission’s Standards Interpretation Group

Phone: 630-792-5900, Option 6Online: http://www.jointcommission.org/Standards/OnlineQuestionForm/

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

today’s featured speaker - point of care. · pdf filestandards interpretation group at...

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