1. Participating in Proficiency Testing Chioma Echeumuna, MT (ASCP), MBA Laboratory Accreditation Specialist p: 312-202-8071 e:cecheumuna@hfap.org 1

2. Objectives Upon completion of this program, the learner will know: What is proficiency testing Why proficiency testing is important Proficiency Testing CLIA requirements What is PT referral Ways to avoid poor PT performance HFAP survey expectations 2

3. What is proficiency testing (PT)? Proficiency testing or PT is the testing of unknown samples from CMS approved PT program, with known value. The purpose is for the laboratory to determine the accuracy and reliability of its testing. 3

4. Why PT is important Quality Assessment: –Verification for the accuracy and reliability of patient testing, methods, and instruments –A method of measuring competency of your employees –Ability for laboratories to compare with peers 4

5. PT Requirements CLIA requirement-Subpart I –Regulated Testing (High or Moderate) Approved CLIA PT program –Exempt Non-regulated testing (High or Moderate, ex. PPM) Waived testing 5

6. Why PT is important (continued) Required for each CLIA certificate 6 CLIA CERTIFICATE CLIA CERTIFICATE CLIA CERTIFICATE CLIA CERTIFICATE Site A Site B Site C PT ONLY Site A Site B Site C

7. PT Requirements Non waived (High and Moderate tests)-not in Subpart I – Not required to perform proficiency testing – Twice a year verifying the accuracy of testing Proficiency tests Blind testing Split patient samples Kodachrome slide 7

8. PT Requirements Microbiology – CLIA requires, for Bacteriology: a total of five PT samples per testing event must be performed PT Testing should be performed on at least one of the types of testing your laboratory performs – (Gram stains, direct antigen, identification of organisms, and/or susceptibility testing). 8

9. PT Requirements Gynecologic cytology – Must be enrolled in a proficiency testing program – This includes: Pathologists, Cytologists other individual qualified to perform gynecologic cytology testing – Keep records – A passing score on all cytology proficiency tests is 90% – 10–slide, test within 2 hours, provided in sets 9

10. PT Requirements Attestation statements -appropriate signature – Laboratory Director – High-LD delegate Technical Supervisor – Moderate-LD delegate Technical Consultant 10

11. Exceptions Laboratories may temporarily be excused from participating in PT – Instances include: Patient testing of the analyte is not be performed at that time Instrument is inoperable at the time A natural disaster transpired. The laboratory must notify HFAP organization when situations such as those mentioned above occurs 11

12. CMS Clarification on Secondary Instrument Reporting CLIA regulations state that “laboratories are not to test proficiency samples of the same analyte on more than one instrument unless that is how patient testing is done for that analyte”. – This applies to: Analytes/tests listed in Subpart I of the CLIA regulations(regulated analytes) Analytes/tests not listed in Subpart I of the CLIA regulations (non- regulated analytes) Waived analytes/tests CMS has indicated that laboratories may test proficiency samples with multiple instrument/methods after the PT due date Failure to comply with these regulations could be considered inter- laboratory communication and a cause for sanctions against the laboratory and the Laboratory Director 12

13. PT Referral The laboratory must not send proficiency testing samples or portions of samples to another laboratory for any analysis which it is certified to perform in its own laboratory, intentionally or unintentionally. This includes laboratories that routinely: – performs only presumptive testing – perform screening methods – refers patient samples to another laboratory – perform definitive, reflex, distributive, confirmatory testing – perform comparison studies of test results Any laboratory that CMS determines intentionally referred its proficiency testing samples to another laboratory for analysis can have sanctions imposed. 13

14. PT Referral (continued) Sanctions –The HFAP does not impose sanctions. Efforts are made to bring the laboratory into compliance and to maintain compliance. 14

15. PT Referral (continued) Types of Sanctions Revoking CLIA license-minimum 1 year Laboratory Director cannot direct a laboratory for two years Laboratory owner may not own or operate a laboratory for two years Potential fine Mandated training of staff 15

16. PT Referral (continued) Sources of inter-laboratory communication –employees who work at another laboratory –pathologists who are laboratory directors –employees who perform consultations 16

17. Avoiding PT Referral –Review PT procedures –Do not discuss PT with another lab –Testing personnel education- annual employee training. –System -detect referred PT samples, –Identify any individuals work in lab, consultants –Create special mock patients –Designate “Not applicable” for the additional or confirmatory testing. 17

18. PT Performance Failures Scores  PT Failure types: –A score below 80% for all regulated analytes except those noted below. –A score below 100% for ABO / Rh group. –A score below 100% for compatibility testing. 18

19. PT Performance Failures Types Unsatisfactory PT performance and Unsuccessful PT Performance 19

20. PT Performance Failures Types Unsatisfactory PT performance – A failure to attain a minimum satisfactory score for an analyte, test, specialty or subspecialty for a testing event. – Example Chloride: 2015, testing event 1 Score=75% 20

21. PT Performance Failures Types (continued) Unsatisfactory Performance (includes) – Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. – Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. – Exceptions: Patient testing was suspended during the time frame The laboratory notifies the AO The laboratory participated in the previous two proficiency testing events 21

22. PT Performance Failures Types (continued) Unsuccessful PT Performance –a failure to attain the minimum satisfactory score for an analyte, test, subspecialty, or specialty for 2 consecutive or 2 of 3 testing events with a rolling time frame. Example: 60% in event 2, and 0% in event 3 –Cease testing –2 Remedial samples 22

23. PT Performance Failures Types (continued) Unsatisfactory or unsuccessful PT performance –must be investigated, documented, remedial action taken. –Notify HFAP 23

24. Remediation of PT failures The laboratory must have a PT failure investigation procedure in place. PT Investigation form to document their findings –HFAP investigation form-pertinent elements included –Laboratory investigation form. 24

25. Remediation of PT failures The laboratory is required to send a copy of the completed Proficiency Testing Deficiency Investigation Report form, including: –back-up documentation, for each failure –documentation stating how the laboratory is handling the testing of that analyte during the next 2 testing events CLIA requires that unsuccessful PT performance be reported to CMS by HFAP 25

26. HFAP INVESTIGATION REPORT FORM 26

27. HFAP INVESTIGATON FORM 27 Patient affected Corrective action Proof of documentation Submitted by Signature & date Lab Director signature & date Staff Review signature & date

28. Reducing Failures CLERICAL ERRORS 1.Check your submission 2.Check information transferred to report form 3.Decimal point, calculations, and units 4.Test method 5.Calculations were performed correctly SPECIMEN HANDLING 1.Review the package insert for the PT on every shipment prior to testing. 2.Inspect that PT for damages 3.Store samples promptly according to instructions 28

29. Reducing Failures QUALITY CONTROL 1.Were quality control materials within the acceptable range on the date of PT testing? 2.Check for trends or shifts CALIBRATION 1.Was calibration performed? 2.What is the frequency requirement for calibration? 3.Verify when the last calibration verification was performed 4.Check documentation there were with calibration problems 29

30. Reducing Failures INSTRUMENT 1. Parameters errors 2. Maintenance performed 3. Repairs or preventative maintenance REAGENTS 1. Check reagent / instrument log 2. Compare reconstitution instructions in package insert to procedure 3. Check open stability of reagent 30

31. Reducing Failures PT MATERIAL 1.Micro- contamination. 2.Exposure-environment 3.Integrity of specimen 4.Reconstitution 5.Matrix effect 31

32. Reducing Failures Competency – Lab &POCT competency 32

33. HFAP inspection-avoiding deficiencies Attestation statements with appropriate signature –Laboratory Director –High-LD delegate technical supervisor –Moderate-LD delegate technical consultant –Testing personnel Evaluation of PT Scoring Irregularities. –Ungraded, nonparticipation, missed deadline-verification of accuracy Primary test system-used Testing Personnel 33

34. HFAP inspection-avoiding deficiencies Number of Times Sampled. PT testing is done in-house. PT records-2 years PT Sample Documentation. Successful Participation. Tests Not Included in PT. –not included in subpart I-non regulated. –included in subpart I-regulated-not offered in CMS approved PT agency 34

35. HFAP inspection-avoiding deficiencies (continued) PT Documentation –documented, reviewed, remedial action Rotation of PT to include all personnel who perform the test PT organized and accessible 35

36. 36 HFAP two-day educational seminar Join us in Washington, DC, September 23-24 Specific content tracks for acute care, physical environment, and laboratory accreditation. Click hereClick here to view the seminar brochure

37. QUESTIONS? 37

38. Email: info@hfap.orginfo@hfap.org Call: 312-202-8258 Visit our Website: www.hfap.orgwww.hfap.org 38

39. References http://www.aab-pts.org/pdf/2016%20Program%20Guide.pdf https://wwwn.cdc.gov/futurelabmedicine/pdfs/Proficiency%20Testing%20report%202007%20.pdf#page=4&zo om=auto,-99,279 http://www.mlo-online.com/quality-control-in-clinical-laboratory-samples.php http://www.mlo-online.com/how-should-a-lab-design-a-fail-safe-system-for-point-of-care-testing.php http://www.mlo-online.com/clia-inspection-deficiencieswhat-they-mean-and-how-to-avoid-them.php http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5413a1.htm http://www.aafp.org/practice-management/regulatory/clia/tests.html http://www.mlo-online.com/clia-requirements-for-proficiency-testing-the-basics-for-laboratory- professionals.php http://www.mlo-online.com/is-your-lab-inspection-ready.php 39

40. References http://wwwn.cdc.gov/cliac/pdf/Addenda/cliac0910/Addendum%20M_Carey.pdf https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Proficiency_Testing_Providers.html http://www.archivesofpathology.org/doi/pdf/10.1043/1543-2165-133.6.979 https://wwwn.cdc.gov/futurelabmedicine/pdfs/Proficiency%20Testing%20report%202007% http://www.mlo-online.com/clia-requirements-for-proficiency-testing-the-basics-for-laboratory- professionals.php https://www.aacc.org/publications/cln/articles/2015/april/tackling-proficiency-testing-failures http://www.pointofcare.net/alabama/CLIAandWaivedTesting071311.pdf20.pdf#page=4&zoom=auto,- 99,279 40