PROFICIENCY TESTING A BRIEF OVERVIEW

1. PROFICIENCY TESTINGA BRIEF OVERVIEW CPT Anne Sterling LTC Paul Mann

2. OUTLINE • WHAT IS PT? & WHY DO WE DO IT? • WHO DOES IT & HOW OFTEN? • HOW IS IT EVALUATED? • WHAT DO RESULTS MEAN? • WHAT HAPPENS WHEN WE FAIL? • HOW TO INVESTIGATE PT

3. PROFICIENCY TESTING • Is a form of external quality control • Is a mechanism to ensure standardized testing across clinical laboratories and evaluate your lab’s performance in comparison to peer groups performance - Uses commercially available materials & evaluations - CAP Surveys

4. WHY DO WE DO IT? • CLIA 88 • CLIP (CCLM) • CAP • TJC • GOOD LABORATORY PRACTICES - Develops confidence in the accuracy and reliability of results

5. WHO IT APPLIES TO? • CLIA ‘88 - ALL TESTING LOCATIONS PERFORMING MODERATE OR HIGH COMPLEXITY TESTING • CLIP - ALL TESTING LOCATIONS PERFORMING MODERATE OR HIGH COMPLEXITY TESTING + Waived (Minimal Complexity) labs are required to be enrolled in a PT program if one is commercially available.

6. WHO IS EXEMPT? • CLIA ‘88 - WAIVED & PPM SITES • CLIP - nobody • LOCAL POLICY - Can be more stringent than CLIA/CLIP. This is what TJC/CAP will hold you to.

7. WHAT IT APPLIES TO ? • CLIA ‘88 - ALL REGULATED ANALYTES • CLIP - ALL ANALYTES

8. Regulated vs UnregulatedAnalytes • Regulated Analytes: Listed in 42 CFR Part 493 Subpart I • Unregulated analytes: those not listed in the CFR

9. HOW OFTEN? • CAP SURVEYS - THREE TIMES A YEAR (MINIMUM OF 5 SAMPLES FOR ALL REGULATED ANALYTES) Unregulated analytes usually have fewer challenges, fewer samples per challenge • FOR TESTS WITH NO COMMERCIAL SURVEYS AVAILABLE - Alternate method (Split Testing) will be performed at least every 6 months

10. HOW IS IT EVALUATED?

11. e-Lab Solutions • The best way to view CAP evaluations is to use e-Lab Solutions • Request access from your institution’s administrator

12. THREE COMPONENTS TO PT PERFORMANCE • the actual result • the target value • the evaluation interval - or acceptable error - for that specimen.

13. THREE DIFFERENT TYPES OF TARGET VALUES • method group (“peer group”) means • means from another group or an all-results mean • values derived from an external source (for example, reference laboratory consensus or definitive/reference methods).

14. FOUR GENERAL TYPES OF EVALUATION INTERVALS • fixed intervals (e.g., + 4 mmol/L) • fixed percentages (e.g., + 10% of the target value) • a combination of these two (e.g., + 6 mg/dL or 10 % of the target value, whichever is greater) • intervals based on the group standard deviation (SD) (e.g., + 2 SD).

15. WHAT DO THE RESULTS MEAN? • WOW!! • IF YOUR IN, YOUR GOOD - GUESS AGAIN • IF YOUR OUT, YOUR INCOMPETENT - PROBABLY, BUT MAYBE NOT

16. CAP Evaluation What Should You Review? • Evaluate each analyte and specimen for negative/positive bias, trends or shifts • Evaluate ungraded challenges

17. EVALUATE RESULTS • QUANTITATIVE - MEAN +/- 2 SD - EVALUATE BIAS - EVALUATE CV - EVALUATE TRENDS • QUALITATIVE - INTENDED RESPONSE - MAJORITY OF RESULTS

18. PT Grading Policy • Minimum passing score of 80%, • 100% for ABO/Rh & Compatibility testing • Passing grades on PT surveys with 5 challenges will require 4 correct, 4 challenges will require 3 correct, 3 or fewer challenges will require all to be correct. • Challenge Failures • Analyte Failures

19. Proficiency Testing Exception Summary (PTES) • Unsatisfactory PT performance • Failure to attain the minimum satisfactory score for an analyte, test, subspecialty, or specialty for a testing event. • Unsuccessful PT performance (2 of 3 testing events) • Failure to attain the minimum satisfactory score for an analyte, test, subspecialty, or specialty for two consecutive or two of three consecutive testing events. • Critical PT performance (3 of 4 testing events) • Failure to attain the minimum satisfactory score for an analyte, test, subspecialty, or specialty for three consecutive or three of four consecutive testing events. A laboratory must immediately cease testing for that analyte or the discipline.

20. WHAT HAPPENS WHEN WE FAIL?

21. UNSATISFACTORY • BE PROACTIVE - determine why - prevent 2nd unsatisfactory performance • INITIATE CORRECTIVE ACTION • PREVENT LIMITATION OF SERVICES

22. 2nd PT Failure

23. UNSUCCESSFUL • STOP TESTING • INVESTIGATE & DETERMINE CAUSE OF FAILURE • EVALUATE PATIENT RESULTS • INITIATE CORRECTIVE ACTION • TRAIN STAFF • EVALUATE CORRECTIVE ACTION (verify on 2 separate occasions) • DOCUMENTATION • REQUEST APPROVAL TO RESUME TESTING

24. Do a Root Cause Analysis A rigorous systematic approach to answering: - What happened & Why?

25. How do we do Root Cause Analysis? • Said simply, Root Cause Analysis is asking why the problem occurred, and then continuing to ask why that happened until we reach the fundamental process element that failed.

26. RCA Goals Find out: What happened? Why did it happen? What do you do to prevent it from happening again? How do we know we made a difference?

27. Team Approach to RCA • QA • Supervisor • Bench Techs • Director

28. Involve Techs? Techs know what happens at the microprocess (bench) level Will give them a sense of accomplishment/contribution Involve in both the investigation and solution development Techs will be the ones that implement the solution

29. Materials Defective Survey Material Wrong Survey Material Machine / Equipment Instrument Malfunction Maintenance Calibration Quality Control Methods SOP written , current, & available SOP adequate SOP followed Man (Management) Training Competency Result Entry Review Process 4Ms of a RCA

30. RCA Methods • How do you determine the cause? • Examine the original test print outs to ensure accurate entry • Verify QC and look at Levy-Jennings graphs to see if there was a problem (drift or shift) that was not caught • Re-test CAP specimen to see if the same result is achieved • Split test with other instruments (other facility) • Verify staff competency

31. CLASSIFY THE PROBLEM Unacceptable results may be classified as follows: Clerical error Methodological problem Technical problem Problem with proficiency testing materials Problem with evaluation of results No explanation after investigation

32. Reasons for Failure

33. INITIATE CORRECTIVE ACTIONS PROVE ACCURACY & PRECISION OF METHOD - RECALIBRATION -PROCEDURAL UPDATE - SURVEY MATERIAL HANDLING & PROCESSING RETRAINING NEW METHOD/INSTRUMENT

34. EVALUATION OF PATIENT RESULTS Review patient data from the time of the unacceptable PT result, to determine whether the problem could have affected patient care If so, appropriate follow-up action should be documented

35. EVALUATE CORRECTIVE ACTIONS Ensure the validity of patient results by verifying on two consecutive occasions that the corrective action taken has resolved the problem This maybe done by reanalysis and/or retesting of frozen or additional PT material, purchase of supplemental PT material, or blind, split-sample testing of patient material with another certified laboratory

36. DOCUMENTATION Document investigation, conclusions, and corrective actions taken Maintain documentation for at least 2 years to include worksheets, instrument tapes, reporting forms, evaluation reports, participant summaries, and documentation of follow-up, as applicable. (5 years for Immunohematology) from the date of event.

38. Director Review The laboratory director will review the effectiveness of the corrective actions and, if satisfied, will document his/her recommendation whether to resume testing.

39. Approval Process • Unsatisfactory: Local • Unsuccessful: RMC • Critical: CCLM

40. Critical • 3rd of 4 PT events • Failed to address the problem, identify the cause, and correct to avoid future problems

41. REQUEST APPROVAL TO RESUME TESTING • MEDICAL DIRECTORS APPROVAL - 1 of 2 or 1 of 3 unsatisfactory performance • RMC APPROVAL - 2 of 2 or 2 of 3 unsatisfactory performance • MEDCOM APPROVAL - 3 of 3 or 3 of 4 unsatisfactory performance

42. Actions Laboratories Should Take when a PT Result is not Graded • Code 11 – unable to analyze • Code 20 – No appropriate target/response cannot be graded • Code 21 – Specimen Problem • Code 22 – Result is outside the method/instrument reportable range • Code 24 – Incorrect response due to failure to provide a valid response code • Code 25 – Inappropriate use of antimicrobial

43. Actions Laboratories Should Take when a PT Result is not Graded cont’d • Code 26 – Educational Challenge • Code 27 – Lack of participant or referee consensus • Code 28 – Response qualified with a greater than or less than sign; unable to quantitate • Code 30 – Scientific committee decision • Code 33 – Specimen determined to be unsatisfactory after contacting the CAP • Code 40 – Results for this kit were not received

44. Education Challenges Code 26 Phase II Is there evidence of evaluation and, if indicated, corrective action in response to "unacceptable" results on the proficiency testing reports and results of the alternative performance assessment system? NOTE: The evaluation must document the specific reason(s) for the "unacceptable" result(s) and actions taken to reduce the likelihood of recurrence. This must be done within one month after the program receives its evaluation. In addition, each ungraded challenge, each educational challenge, and each episode of nonparticipation must be reviewed and corrective action instituted as appropriate.

45. Actions Laboratories Should Take when a PT Result is not Graded cont’d • Code 41 – Results of this kit were received past the due date • Code 42 – No credit assigned due to absence of response • Code 44 – This drug is not included in our test menu. Use of this code counts as a correct response

46. CONCLUSION • EVERY EFFORT SHOULD BE MADE TO FIND THE CAUSE(S) OF AN UNACCEPTABLE PT RESULT. • ACTIONS TO IMPROVE THE LABORATORY SYSTEM WILL MINIMIZE THE RISK OF RECURRENCE AND POTENTIALLY IMPROVE THE QUALITY OF PATIENT RESULTS.

47. QUESTIONS?