Today s Featured Speaker

Transcription

1 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 Pg. 1

2 Point-of-Care Testing: Putting Together the Accreditation Puzzle September 16, 2009 Bay State Webinar Megan E. Sawchuk, MT(ASCP) Associate Director Standards Interpretation Group Point-of-Care Testing, Sep Pg. 2

3 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 Pg. 3

4 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 Pg. 4

5 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 Pg. 5

6 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 Pg. 6

7 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 Testing FAQ on website Point-of-Care Testing, Sep Pg. 7

8 Biosensor Technology FAQ Point-of-Care Testing, Sep Pg. 8

9 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 Pg. 9

10 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 Pg. 10

11 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 = nonwaived; Initial certificate for new lab) Certificate of Accreditation (CoA) (Moderate & high = nonwaived; certificate after survey from accreditor, e.g. TJC) Other CLIA certificate types (N/A to TJC accredited) Certificate of Compliance (CoC) (Moderate & high = nonwaived; certificate after lab has been state inspected) Point-of-Care Testing, Sep Pg. 11

12 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 Pg. 12

13 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 Pg. 13

14 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 Pg. 14

15 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 , 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 Pg. 15

16 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 Pg. 16

17 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 Pg. 17

18 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 , 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 Pg. 18

19 Point-of-Care Testing, Sep Pg. 19

20 But what does it all mean? Point-of-Care Testing, Sep Pg. 20

21 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 Pg. 21

22 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 Pg. 22

23 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 Pg. 23

24 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), 2 nd 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 Pg. 24

25 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 Pg. 25

26 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 Pg. 26

27 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 Pg. 27

28 What is required for POCT competency assessments? Point-of-Care Testing, Sep Pg. 28

29 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 Pg. 29

30 Competency Frequency and content vary by test complexity Waived (WT.1.30 or WT ) 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 Pg. 30

31 What are some of the common POCT challenges? Point-of-Care Testing, Sep Pg. 31

32 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 Pg. 32

33 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 Pg. 33

34 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 Pg. 34

35 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 Pg. 35

36 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 Pg. 36

37 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) HealthNotifications/ucm htm Point-of-Care Testing, Sep Pg. 37

38 Comparison of Requirements Joint Commission Requirement CLIA certificate Nonwaived Yes Certificate of Accreditation (COA) Waived Yes Certificate of Waiver (COW) Establish P&P Yes Yes Initial training and annual competency Yes Semiannual in 1 st year Yes 2 levels of QC each day Reference intervals on patient chart Yes 3 for ABGs Yes Yes Yes Quantitative results Critical value reporting Yes Yes Point-of-Care Testing, Sep Pg. 38

39 Comparison of Requirements Joint Commission Requirement Nonwaived Waived Method validation Yes No Equivalent QC (EQC) validation Semiannual correlation studies Yes Yes No No Semiannual calibration verification Yes Proficiency testing 3x/year Yes No No Point-of-Care Testing, Sep Pg. 39

40 Web Sites Centers for Medicare and Medicaid Services (CMS) Centers for Disease Control and Prevention (CDC) Food and Drug Administration (FDA) The Joint Commission s Frequently Asked Questions (FAQs) Point-of-Care Testing, Sep Pg. 40

41 Contact The Joint Commission s Standards Interpretation Group Phone: , Option 6 Online: Point-of-Care Testing, Sep Pg. 41

42 Thank you! Point-of-Care Testing, Sep Pg. 42