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

2. PMS OBJECTIVES GENERAL: –Measure Oraquick utilization –Test outcomes – number of reactives/non-reactives –Describe proportion of clients who receive their results –Seropositivity rate versus ‘conventional’ tests –Adverse outcomes PROJECT DURATION 7/04  12/04 LABORATORY –Document QC practices Frequency and reason for running controls Incidence of failed control runs –Incidence and significance of discordant confirmatory tests –Incidence and significance of invalid test results

3. Where we are currently - What the Post-Marketing Surveillance will mean for you What new tools will be put in place in the laboratory to achieve these objectives Introduction

4. Principle Minimize the number of forms Maximize the information on each form Refine the process as we go along

5. Testing sites Ongoing Responsibilities Log temperatures Run & log QC Log client tests Run & log PT occasionally Notify us of confirmatory tests Get re-certified periodically

6. Why is Quality control needed?: Check reagents--they can deteriorate Check reagent storage--they can deteriorate faster Check operator proficiency--their memory or skills can deteriorate

7. The Patient Test Log Central document which oversees the laboratory’s performance Quality Control is documented every time it is performed New field is being added to the Patient Test Log: “Reason for Performing QC”

8. Do you need to run controls? YES! – why? The storage area has been too hot at some point (93 °F) Storage Temperatures: [35.6 °F  80 °F] (2-27 °C) Testing Temperatures: [59 °F  80 °F ] (15-27 °C) Current Temp MinimumMaximum

9. Patient Test Log (Revision) New Column

10. Codes to be used “Reasons for Performing QC” 1.It is the FIRST DAY of a new testing week 2.STORAGE TEMPERATURE is out of range 3.CONFIDENTIAL testing MAY be performed today 4.NEW SHIPMENT has arrived 5.An INVALID RESULT was obtained 6.QUALITY CONTROL failed 7.Coordinator assigned MONTHLY QC testing to you 8.OTHER – e.g.You are uncomfortable for whatever reason

11. PMS Protocol Oraquick Quality Control Log Sheet If performed by an individual site QC log will include: –Date –Counselor Number –Lot Number –Control Expiration Date –Date Control was Opened –Results –Number of Tests between controls –Reasons for doing control New OperatorExpired Control Change in EnvironmentOther Daily Quality Control Among the sites we oversee we have opted NOT to have you complete the Quality Control Log sheet – we will generate aggregate data from your patient test log If your laboratory is not operated by RWJMS, your laboratory director will need to specify how you are to provide this data to the CDC.

12. Aggregate Data on Control Practices Centrally, we will determine from your patient test logs: –Total number of sets of controls during the data collection period –Number of failed controls – with narrative details (on back of patient test log) indicating control lot number, test kit lot number, date control vial was opened, expiration date of controls, and problem resolution –Median number of clients tested between control runs with min/max and 25%/75% percentiles for number of clients tested between runs –Distribution of reasons for running controls

13. Discrepant Analysis An infrequent event ( Statewide ~ 20X per year) which will require an individualized response –Oraquick PRELIMINARY POSITIVE, but a CONFIRMATORY RESULT that is negative or indeterminate We wish to work directly with staff from any institution that experiences a discrepant result

14. Discrepant Follow-up Counseling issues – We are ‘on-call’ to come to your site at the time you have a follow-up meeting with your client –If scheduling permits, one of us will be present; or we can arrange to provide telephone consultation if this is preferred. –Make sure that your follow-up appointment is flexible! Additional testing will be provided at no cost to the site or to the patient. This will include hepatitis and viral load testing. Basically,

15. Notification Phone: 732 235-8112 (Franchesca Jackson) – 732 235-8114 (Dr. Martin) Email: - cadoff@umdnj.edu cadoff@umdnj.edu –martineu@umdnj.edumartineu@umdnj.edu Cell Phone – Dr. Martin (732) 977-8101 If you don’t need a response immediately email works best for all of us – it provides a record of the call and can’t get lost!

16. As you prepare to test a client with OraQuick, run through this entire checklist : 1.Check reagent storage thermometer. –If min or max temperature is out of range, proceed to step 2, but then run quality control tests. 2.Look at the temperature log. –If it is not yet filled out for today, record the temperature and reset the thermometer. –If the temperature log is not filled out for today, also record the refrigerator temperature and reset the thermometer. If the refrigerator temperature is out of range, indicate on the back of the log what you (or your coordinator) did to fix the problem. –If you need to run quality control tests from step 1, go to step 5 and do that now (use reason 2).

17. 3.Look at the testing log. –Was the last test result in the log invalid? If so, find out who’s working on the invalid test, or proceed to step 5 and run quality control tests (use reason 5) –Were control samples run on Monday? If not, proceed to step 5 and run quality control tests (use reason 1) 4.Is testing confidential? –If yes, were control samples run today? If not, proceed to step 5 and run quality control tests (use reason 3) If you do not need to run quality control for any reason above, run the client test according to the testing procedures you have learned. If you get an invalid result, see step 6.

18. 5.Running quality control: –On the testing log, record that you are running control tests, and what the reason is. –Run the control tests and record the results. The positive control should have a positive result (C and T lines). The negative control should have a negative result (C line, but no T line). –If the control results are not what they should be, or if they are invalid, repeat the test –If you need to repeat the test, use a new box of controls if you have them, and throw out the old ones. –If the control results to not work a second time, call us for help. You cannot test your client using OraQuick and should either have them come back another time or use OraSure.

19. 6.Invalid client results –If you get an invalid result on a client, enter the invalid in the log. On the back of the log write why the test was invalid (for example, “No C line” or “Lines not inside the triangle” or “No lines”) –Complete the invalid test report form –If the client agrees, repeat the test. –If the result is invalid twice, run quality control (reason 6) before running another client. –If the client doesn’t want to be tested again, run control samples (reason 5) –Don’t leave the test log with an invalid result as the last entry

20. 7.You need to run quality control samples at least once each month. –If you notice that it’s near the end of the month, or your coordinator asks you, run your monthly quality control samples using reason 7.