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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.
Point-of-Care Testing, Sep. 2009 – Pg. 2
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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
Point-of-Care Testing, Sep. 2009 – Pg. 3
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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
Point-of-Care Testing, Sep. 2009 – Pg. 4
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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
Point-of-Care Testing, Sep. 2009 – Pg. 5
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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)
Point-of-Care Testing, Sep. 2009 – Pg. 6
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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
Point-of-Care Testing, Sep. 2009 – Pg. 7
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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
Point-of-Care Testing, Sep. 2009 – Pg. 8
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Biosensor Technology FAQ
Point-of-Care Testing, Sep. 2009 – Pg. 9
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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
Point-of-Care Testing, Sep. 2009 – Pg. 10
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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
Point-of-Care Testing, Sep. 2009 – Pg. 11
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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)
Point-of-Care Testing, Sep. 2009 – Pg. 12
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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
Point-of-Care Testing, Sep. 2009 – Pg. 13
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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?
Point-of-Care Testing, Sep. 2009 – Pg. 14
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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
Point-of-Care Testing, Sep. 2009 – Pg. 15
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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)
Point-of-Care Testing, Sep. 2009 – Pg. 16
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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)
Point-of-Care Testing, Sep. 2009 – Pg. 17
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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
Point-of-Care Testing, Sep. 2009 – Pg. 18
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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
Point-of-Care Testing, Sep. 2009 – Pg. 19
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Point-of-Care Testing, Sep. 2009 – Pg. 20
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But what does it all mean?
Point-of-Care Testing, Sep. 2009 – Pg. 21
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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
Point-of-Care Testing, Sep. 2009 – Pg. 22
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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.
Point-of-Care Testing, Sep. 2009 – Pg. 23
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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)
Point-of-Care Testing, Sep. 2009 – Pg. 24
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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.
Point-of-Care Testing, Sep. 2009 – Pg. 25
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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
Point-of-Care Testing, Sep. 2009 – Pg. 26
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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
Point-of-Care Testing, Sep. 2009 – Pg. 27
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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)
Point-of-Care Testing, Sep. 2009 – Pg. 28
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What is required for POCT competency assessments?
Point-of-Care Testing, Sep. 2009 – Pg. 29
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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
Point-of-Care Testing, Sep. 2009 – Pg. 30
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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
Point-of-Care Testing, Sep. 2009 – Pg. 31
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What are some of the common POCT challenges?
Point-of-Care Testing, Sep. 2009 – Pg. 32
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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
Point-of-Care Testing, Sep. 2009 – Pg. 33
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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
Point-of-Care Testing, Sep. 2009 – Pg. 34
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Equivalent QC / Alternative QC
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
Point-of-Care Testing, Sep. 2009 – Pg. 35
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Equivalent QC / Alternative QC
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
Point-of-Care Testing, Sep. 2009 – Pg. 36
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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
Point-of-Care Testing, Sep. 2009 – Pg. 37
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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
Point-of-Care Testing, Sep. 2009 – Pg. 38
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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
Point-of-Care Testing, Sep. 2009 – Pg. 39
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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
Point-of-Care Testing, Sep. 2009 – Pg. 40
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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
Point-of-Care Testing, Sep. 2009 – Pg. 41
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Contact The Joint Commission’s Standards Interpretation Group
Phone: 630-792-5900, Option 6Online: http://www.jointcommission.org/Standards/OnlineQuestionForm/
Point-of-Care Testing, Sep. 2009 – Pg. 42
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Thank you!
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