Robert Wood Johnson Medical School

1. HIV Point of Care Testing Program Robert Wood Johnson Medical School 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. GOALS FOR TODAY • STATUS REPORT: • LABORATORY TRAINING • GENERAL OVERVIEW: • QC Principles • Logging • Reporting • Proficiency Testing • Troubleshooting • BLOODBORNE PATHOGENS • IMPLEMENTATION TRAINING: • HIV ORASURE Oraquick

3. CONCEPT REVIEW Distribution of Responsibilities

4. Monthly visit: Delivery of reagents and supplies Review testing records Competency review Problem solving (additional visits as needed) As needed: Reagent validation State inspection Preliminary positive follow-up Troubleshooting Annual: Personnel forms License CLIA registration Order Proficiency Tests Competency assessment 3-4 times per year: Collect and evaluation PT results Refresher/new-hire training: Monthly review: Test logs Temperature logs Inventory Internal proficiency testing Central POCT responsibilities

5. Licenses Personnel forms Coordinator contact information Correct address Procedures Read them Read manufacturer’s package insert Follow them!! Procedures for preliminary positives Quality control Check reagents Check reagent storage Check operator proficiency On-board and external (liquid) controls Proficiency Testing External audit of performance Reviewed by state for licensure Once pre-licensure 3 times per year: CAP Monthly, POCT program All PT tests/results through POCT office Responsibilities of the Testing and Counseling Centers

6. STATUS REPORT

7. Status Report – • Limited Purpose Laboratory Regulation and Health Care Emergency • Licenses: • Applications • Licensed sites 1 – New Brunswick • Applications completed 13 • NJ Site visits have occurred at all sites • One site has withdrawn - RBMC • One application is incomplete • Three licenses are being held because of an inadequate number of trained personnel – Being addressed today and tomorrow • CLIA registration has been submitted for all licensed sites • Implication: • Anticipate ‘Go Live’ at all sites this week • Satellite sites will come on line this summer

8. What is a satellite site? • A satellite site is, at least at the outset, a fixed location that will be serviced by the same group of personnel who have been trained and qualified through the primary lab • A satellite must use the same procedures, the same personnel, the same QA program as the primary site • Because personnel are proficiency assessed at the primary site, the site is not required to separately perform proficiency testing.

9. What will we need to do? • We have already been provided list of satellites being serviced by each primary site • We are currently establishing procedures which will tell you how we will bring up a satellite and what arrangements will need to be made: • Transportation of supplies vs secure storage • Quality Control issues related to reagent monitoring (e.g. temperature of devices/controls • Record keeping • Site assessment • Time frame – months - starts later this summer

10. Status Report – May, 2004 • Written Procedures • All procedures – testing, reporting, administration, supervisory are completed. • Website: • A URL has been secured (http://www.njhiv.org) • eMail for all sites will be provided • Site has ALL current forms and procedures available • Training: • Today – At the end of training we anticipate you will be prepared to participate in testing, quality assurance and proficiency testing • Additional training: • South – Tomorrow • North – ? • Central – Today • Tentative Site Visit Schedule: June July August Sept • Route #1: 6/2 7/7 8/4 9/1 • Route #: 6/9 7/14 8/11 9/8 • Route #3: 6/16 7/16 8/18 9/15 • Route #4: 6/18 7/21 8/20 9/17 • Route #5: 6/28 7/28 8/24 9/28

11. LABORATORY TRAINING General Concepts

12. Basic Elements of Laboratory Training • Training - Laboratory & Bloodborne Pathogens • Reagent supply and validation • Quality Control and Quality Assurance Procedures • Reporting requirements • Proficiency testing & Competency Assessment • Supervisory oversight

13. What is Quality Control? • Elements: • 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. • What happens if there is a problem Records that permit follow-up by lot and by patient • Do operators perform testing properly? Annual operator certification. Biennial certification in Year One • Are transport and storage conditions satisfactory? Temperature records. Transport containers and conditions.

14. Our Quality Assurance Program • Participation in Interlaboratory comparison programs: • CAP Proficiency testing • NJ DOH - Proficiency Testing Program • AAB - American Association of Bioanalysts  • Internal Laboratory quality control program: • Why? • Provide for a comprehensive process for review of QC data and the release of results • Provide a mechanism for the review of inconsistent findings by laboratory professionals • Elements: • Daily procedures, including:  • Generation of mandated QC • Generation of daily laboratory reports in a consistent, retrievable manner • Periodic Meetings of the POCT oversight committee. • Purpose:Review ongoing technical problems and their resolution • Review problem cases • Review of proficiency testing performance • Review customer service issues                    • Quality Assurance Indicator Program • On a quarterly basis, quantitative indicators that reflect identifiable issues of quality are collected. Acceptable performance is decided in advance and reviewed.. • Formal Education and Competency Assessment Program

15. Quality Assurance Logs Test records QC results PT results Competency Assessments Inventory control Temperature logs Preliminary positive test log Reagent/supply ordering Competency assessment Initial training (all elements above) 6 month reassessment Annual reassessment Monthly internal PT and observation Training/Competency assessment Review procedures Review QA plan Run QC Run Proficiency Testing Examiner observations Written test Elements of Quality Assurance

16. CONCEPT: Proficiency Testing Program • External unknowns are received from CAP • Analyzed by testing personnel as they would a patient specimen • Results are returned • Six to eight weeks later nationwide results are received: • Good • Acceptable • Unacceptable • Unacceptable results require a Deficiency Response to be returned to CAP after an investigation into the failure

17. SPECIFICS: Proficiency Testing Program • Specimens will be sent to you directly from the College of American Pathologists (CAP) during the weeks of: • Feb. 9, 2004 – THESE WERE YOUR PRE-LICENSURE RESULTS! • May 3, 2004 – Recently completed. • Sept 20, 2004 If specimens are not received within 5 days of these dates we should be notified!! Tight time frame • Fran Jackson will generate an email reminding you of this a few days before each shipment • These specimens should be received by each site and be tested promptly • CAP proficiencies contain an attestation that the test has been performed as you would a patient specimen – THIS NEEDS TO BE SIGNED BY THE INDIVIDUAL PERFORMING THE TEST!! • Results are to be reported back to our office within 5 days by fax set to FINE or EXTRA FINE!! • Dr. Cadoff will sign off on these centrally and we will relay them to CAP • An individual who successfully participates in a PT event will be recertified!

18. Supervisory Review • Coordinator’s MUST review all testing performance – weekly! • Signature and Date on the testing log. • DO NOT backdate should you fail to review testing at your site. • Monthly – Send/Fax copies of your logs to us • UDL professional staff will review monthly for completeness and correctness • Evidenced by signature and date on testing log

19. Orasure Oraquick HIV Details of Testing

20. Orasure OraQuick Qualitative HIV • Quality control is essential. External Quality Control MUST BE PERFORMED. • With each new shipment of reagents • At the beginning of each week • Each month, by each person doing testing • Whenever there has been a change in the test environment – room or storage • THIS INCLUDES: • When Temperatures have exceeded manufacturer’s specifications: 2°–27° C (35° – 80°F) • A new testing location is being utilized • Room lighting has been significantly altered • 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. • Remove the cap from the vial, making sure that you are wearing disposable gloves.

21. Expiration Dating • Single biggest problem in POCT testing • Expiration dating varies based on reagent or control solution • Refer to the UDL sheet or the manufacturer’s package insert • IT MATTERS!! Why? HIV reagents: Expiration of control reagents – 21 days after opening!! Kits – Storage requirements - < 80° F. If not, you must run QC to prove the reagents are still performing properly • Storage of reagents • Single biggest problem in POCT testing • Expiration dating varies based on reagent or control solution • Refer to the UDL sheet or the manufacturer’s package insert • IT MATTERS!! Why? HIV reagents: Expiration of control reagents – 21 days after opening!! Kits – Storage requirements - < 80° F. If not, you must run QC to prove the reagents are still performing properly • Storage of reagents

22. Oraquick Qualitative HIV Antibody • Clean the finger of the person being testing with an antiseptic wipe, and allow it to dry. • Take a clean, unused Specimen Collection Loop, and fill the loop completely with blood. • 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. • 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.. INTERPRETATIONS: • PRELIMINARY Positive – Lines at T and C • NEGATIVE – Line at C • INVALID – No line at C – Do not report the result. • Complete the testing log (whether test was successful or not). • If Quality Control is not correct, consult procedure manual. Do not test patients.

23. ORAQUICK HIV • KEY POINTS • 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 developer vials – Mix thoroughly THEN • Add testing device and begin timing. Developer Solution SpecimenCollectionLoop Test Device

24. Add specimen and mix!!

25. 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

26. A 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!!

27. 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?

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

29. Checklists Testing & Client

30. Testing Site Checklist I: • Daily: • Log Temperature checks: • Refrigerator • Room • Reagent Storage • Perform QC at a minimum: • Every Monday • Whenever new shipments are received • Check QC rotation schedule to insure that all are participating • Perform testing (see Client Testing Checklist) • Fax all preliminary positives Fran at RWJMS (732) 235-8113 • Weekly • Supervisory review of testing log sheets by site coordinator

31. Testing Site Checklist II • Monthly: • Inventory review  Fax Fran with needs prior to next visit • Fax testing logs with evidence of weekly review  Fran • Perform internal UDL proficiency testing during monthly visit • Periodically • Fax confirmed results to Fran at RWJMS (732) 235-8113 • Fax COMPLETED CAP proficiency test results: • February 16, 2004 • May 10, 2004 • Sept. 27, 2004 • Respond to Proficiency Testing Exception Reports • Download, duplicate and distribute REVISED procedures • Site specific issues – as needed

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