1. Robert Wood Johnson Medical School HIV Point of Care Testing Program Eugene G. Martin, Ph.D. Evan M. Cadoff, M.D., BLD Associate Professors of Pathology and Laboratory Medicine UMDNJ – Robert W. Johnson Medical School

2. Status Report – February, 2004 Written Procedures  Site-specific bloodborne pathogen procedures are needeed  Letter of agreement with center owner is needed (more info to follow) All other procedures – testing, reporting, administration, supervisory are completed. Website: A URL has been secured (http://www.njhiv.org)http://www.njhiv.org eMail for all sites will be provided  Site activation is anticipated – February, 2004 Training:  Today – The person who completes training and competency assessment today performs the CAP Prelicensure survey  Prelicensure visits (BEING ARRANGED NOW for MARCH) – NJDHSS & UDL  Additional training (POSSIBLE DATES):  South – March 18 th  North – April 1  Central – April 22 Site Visits: AprilMayJuneJulyAugustSept  Route #1: 4/75/56/27/78/49/1  Route #2: 4/145/126/97/148/119/8  Route #3: 4/165/196/167/168/189/15  Route #4: 4/215/216/187/218/209/17  Route #5: 4/285/286/287/288/249/28

3. Status Report – February, 2004 Licenses: –Applications √ Licensed sites 1 – New Brunswick √ Applications completed 15 –Prelicensure Issues √ Prelicensure discussion with CLIS.  Simultaneous submission.  Prelicensure survey – scheduled week of Feb. 9 th at all sites  Licensure for HIV testing as soon as results are available from CAP  CLIS to CMS for CLIA registration upon completion Implication:  Anticipate ‘Go Live’ date in March for all sites

4. Basic Elements of Laboratory Training Quality Assurance Plan Bloodborne pathogen training OraQuick Testing, including quality control reporting requirements Confirmatory Testing Supervisory oversight

5. Elements of Quality Assurance Competency Assessment and Operator Certification Quality Assurance Quality Control Proficiency Testing Test records (Patient, QC, PT) Inventory control Temperature logs Preliminary positive test monitoring

6. Central POCT QA responsibilities Centralilzed procedures Inventory control Monthly visit: –Delivery of reagents and supplies –Review testing records –Competency review –Problem solving (additional visits as needed) Central monitoring –Completion of logs –Preliminary positive follow-up QA indicators

7. Coordinator responsibilities Quality Assurance Inventory control Monthly: –Review testing records –Competency review –Problem solving QA indicators

8. Training/Competency assessment Review procedures (we prepared them; you read them) Review QA plan Run QC Run Proficiency Testing Examiner observations Written test

9. Competency Reassessment 6 month reassessment Annual reassessment Monthly QC Internal PT (at monthly visits) Direct observation (at monthly visits) Written test

10. Coordinator Responsibilities Training/Competency assessment Schedule counsellors for training sessions.

11. Coordinator Responsibilities Competency Reassessment 6 month reassessment Annual reassessment Monthly QC Internal PT (at monthly visits) Direct observation (at monthly visits) Written test

12. What is Quality Control? –Does a new reagent lot perform properly?  Lot Validation – performed centrally –Chemical reagents deteriorate. How do you assure yourself that procedures are working properly?  Check with known QC specimens regularly (weekly) –Do operators perform testing properly?  Run QC at least once a month –Are transport and storage conditions satisfactory?  Run QC every shipment, and if storage temperature is out of range –What happens if there is a problem?  Records permit follow-up by lot and by patient

13. Responsibilities of the Counselors Quality control QC weekly (every Monday) QC each shipment QC by each person monthly (ie Rotate this responsibility) Control line and background color each test If anonymous testing is being done

14. Coordinator Responsibilities Quality Control –Check QC log weekly –Each operator must run QC at least once a month

15. What is Proficiency Testing? External audit of performance –External unknowns are received from CAP 3 times per year –Results graded to national norms –Reviewed by state for licensure Analyzed by testing personnel as they would a patient specimen Unacceptable results require investigation and a written response RWJMS Internal Proficiency Testing –Part of monthly oversight visits –Part of operator recertification process

16. Responsibilities of the Counselors Specimens will be sent to you directly from the CAP during the weeks of: –Feb. 9, 2004 – THESE WILL BE YOUR PRE-LICENSURE RESULTS!! –May 3, 2004 –Sept 20, 2004 These specimens should be tested promptly Sign the Attestation Statement Fax results back to our office within 5 days (fax set to FINE or EXTRA FINE!!) Dr. Cadoff will sign off on these centrally and we will relay them to CAP Successfully participation in a PT event is part of the operator recertification process and state licensure!

17. Coordinator Responsibilities Proficiency Testing Unacceptable results require investigation and a written response RWJMS Internal Proficiency Testing –Part of monthly oversight visits –Part of operator recertification process

18. Why Inventory Control? Standardization of reagents and supplies Validation of reagents Replacement of supplies and consumable Bulk purchasing (save $$)

19. Responsibilities of the Counselors Don’t buy your own stuff. Ask us for it. Use the order form and/or call Fran Fran will call you before your next scheduled visit Anticipate your needs

20. Coordinator Responsibilities Inventory Control: Don’t buy your own stuff. Ask us for it. Use the order form and/or call Fran Fran will call you before your next scheduled visit Anticipate your needs

21. Why Temperature Control? Reagents deteriorate Manufacturer validated storage conditions (35-80 o F) Corrective action if temperatures are out of range

22. Temperature Monitoring

23. Responsibilities of the Counselors Record storage temperatures daily –Refrigerator (controls) and Storage room (OraQuicks) –Testing areas –Reset Min/Max thermometers If storage temperature out of range, perform QC If testing area out of range, TEST ELSEWHERE

24. Coordinator Responsibilities Temperature Control: Review temperature logs weekly Send logs to Fran monthly

25. Why Testing Logs? Control inventory (Are we almost out? Are tests missing?) Reagent recall (Need lot numbers! Can we call clients back?) QC monitoring (Was it done yet today? Did I run my required QC this month?) PT monitoring (Competency assessment tool) Problem logs (What happened?) Logs will be reviewed centrally each month

26. Responsibilities of the counselors Check Expiration dates Record QC, PT, client testing in the log Record reagent and QC lot numbers Check the temperature and testing logs before running a test, to see if QC is needed Document any problems on the back of the log, with a note on the front Site coordinators need to review them weekly, and send them to Fran each month. Sign legibly! (Name once per sheet, then initials, is OK)

27. Coordinator Responsibilities Testing logs: Review testing logs weekly Review QC rotation before month-end Send logs to Fran monthly

28. Why monitor Preliminary Positives? Check OraQuick’s performance Check appropriateness of confirmatory testing system (phlebotomy vs fingerstick) This is new to all of us

29. Responsibilities of the counselors Collect specimen for confirmation –Phlebotomy preferred –Fingerstick acceptable Fill out Prelim Positive form for all positives Fax the form to Fran When confirmatory result is back, add it to the form and send/fax it to Fran

30. Coordinator Responsibilities Preliminary Positives: Make sure Prelim Positive forms are completed and faxed to Fran Phlebotomy services should be made available (counsellors? contract?)

31. LABORATORY TRAINING General Concepts

32. Orasure Oraquick HIV Details of Testing

33. Orasure OraQuick Qualitative HIV Check Test and Temperature log to see if QC is needed CHECK EXPIRATION DATES!! Once opened, Orasure External QC reagents are only good for 21 days if stored in the refrigerator! Put on gloves. Open both portions of the test pouch. Make sure that an absorbent packet was packed with the test device. If not, discard the device and open a new pouch. Label both the Developer Solution Vial and the test Device with the subject’s name or ID. –Be careful not to block or cover the two holes on the back of the test device. –You might want to position the tube so you can see through it without the paper label in the way. Remove the cap from the vial, making sure that you are wearing disposable gloves.

35. ORAQUICK HIV POINTS TO REMEMBER –Label both the test device AND the developer solution with an identifier –Timing begins when you add the test device to the developer solution! –Several specimens can be set up together by placing specimen loops into the labeled developer vials – Mix thoroughly, THEN –Add labeled testing devices and begin timing.

36. Oraquick Qualitative HIV Antibody Clean the finger of the person being testing with an antiseptic wipe, and allow it to dry. Spring-load the lancet, and puncture the finger a little off-center of the fingertip. Take a clean, unused Specimen Collection Loop, and fill the loop completely with blood. Give the person gauze and have them squeeze to stop bleeding.

37. Oraquick Qualitative HIV Antibody Insert the blood-filled end of the loop into the solution in the vial and stir. If blood did not fully fill the loop, or if the solution is not pink, discard the test materials and start again. Insert the flat pad of the test device (labeled with the test subject’s ID) into the vial with the blood in the developer solution. Make sure that the pad touches the bottom of the vial, and that you can see the result window.

38. Oraquick Qualitative HIV Antibody Start timing the test. Record the start time on the test log sheet. Read the results after at least 20 minutes, but not more than 40 minutes have passed. If the test is not read within 40 minutes, discard the test materials and start again. The test is INVALID..

39. INTERPRETATIONS: –PRELIMINARY Positive – Lines at T and C –NEGATIVE – Line at C –INVALID – No line at C, too much pink background, extra lines, or anything else odd – Do not report the result. –No other interpretations! Complete the testing log (whether or not the test was successful). If Quality Control is not correct, consult procedure manual. Do not test patients.

40. Test Validity A red control line must appear within the C triangle. –If it is absent, the test is INVALID –If the line appears outside the C triangle, the test is also INVALID

41. INVALID RESULTS Red background interferes with interpretation No control line is visible Control line is outside C triangle What’s that at the top of the cassette?

42. A PRELIMINATRY POSITIVE RESULT Read between 20 and 40 minutes A line is present within the C triangle Another line is present within the T triangle NO MATTER HOW FAINT Intensity of the T line IS NOT related to antibody concentration!!

43. A Negative result A red control line appears within the C triangle. No other line, no matter how faint appears in the T triangle

44. REPORTING GUIDELINES: All testing results must be i n the testing log  INCLUDING QC checks, training tests, invalid test results QC results must be in the log.  Check it before doing any patient testing. The responsibility to perform QC must be rotated amongst all testing personnel. Lot numbers of reagents and controls must be in the log.  When you open a new box place the lot information on the reporting sheets provided with the box. All testing personnel will initial the Testing Log for any test performed. A legible signature is required at least once per Testing Log sheet. The onsite POCT coordinator must review the logs weekly (INITIAL AND DATE), and send them to the POCT office monthly. Testing logs will be reviewed during site visits. A failure to perform weekly supervisory review will be noted as a part of the visit checklist.

45. Checklists/Summary Testing & Daily Checklists

46. Testing Site Checklist I: Daily:  Log Temperature checks:  Refrigerator  Room  Reagent Storage  Check expiration dates  Perform QC at a minimum:  Every Monday  Whenever new shipments are received  If storage temp was out of range  Check QC rotation schedule to insure that all are participating and on track  Perform testing (see Client Testing Checklist)  Fax all preliminary positives Fran at RWJMS (732) 235-8113

47. Checklist for Client Testing Client Testing:  Check Expiration dates  Make sure QC is current  Check room temperature  Use personal protective equipment  Check for desiccant pack  Label the vial AND the test device  Check the loop for complete filling  Read after 20 minutes, but less than 40 minutes  All lines must be within the triangle!  Record results in the testing log

48. Checklist for Coordinators Weekly:  Review and sign logs (temperature log and test records) weekly Monthly:  Review QC rotation before month-end  Send test logs to Fran  Check for recertifications due Periodically (per calendar):  Expect CAP PT samples  Make sure CAP PT results are faxed in As needed:  Troubleshooting

49. To Do List for RWJMS and Coordinators Letter of agreement between RWJMS and site owner (including evidence of liability insurance) Bloodborne pathogen procedure, including emergency care plan in the event of exposure Phlebotomy arrangements

50. Someone who completes training and competency assessment today performs the CAP prelicensure survey the week of Feb 9!

51. When the state (CLIS) gives the go-ahead, you’re ready to test!