1. HIV Point of Care Testing Program
Robert Wood Johnson Medical School
<Presenter>
UMDNJ – Robert Wood Johnson Medical School

2. Status Report – NJ Rapid HIV Testing
Federal regulation (CLIA) requires:
Testing in a laboratory
Follow manufacturer’s instructions
Implement a Quality Assurance Plan
New Jersey (CLIS) requires:
State laboratory license
Proficiency testing
Current status
15 licensed primary sites
31 licensed satellite sites
Over 50 CTS sites

3. GOALS FOR TODAY Quality Assurance Bloodborne pathogen training
Logging
Reporting
Proficiency Testing
QC Principles
Troubleshooting
Bloodborne pathogen training
Hands-on OraQuick testing
Supervisory review

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

5. 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
Discrepant result follow-up

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

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

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

9. Coordinator Responsibilities
Training/Competency assessment
Schedule counsellors for training sessions.
Help keep track of counsellors in need of recertification

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

11. Performance Improvment
Periodic projects to monitor and improve performance
Counselors and coordinators may be asked to gather data

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

13. 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

14. Proficiency Testing
Specimens will be sent to you directly from the CAP in:
early February
early May
late September
These specimens should be tested promptly
Sign the Attestation Statement
Fax results back to our office within 5 days ( xxxx)
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!

15. 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

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

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

18. 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

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

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

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

22. Temperature Monitoring

23. Temperature Checks Record storage temperatures daily
Refrigerator (controls) and Storage room (OraQuicks)
Testing areas
Reset Min/Max thermometers
If storage temperature out of range (35-80oF), perform QC
If testing area out of range (59-99oF), TEST ELSEWHERE

24. Temperature Log
POCT HIV Temp Log (ONLY) - PDF

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

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

27. Why 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

28. 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
If storage temperature is out of range

29. Coordinator Responsibilities
Quality Control
Check QC log weekly
Each operator must run QC at least once a month
More detail to come!

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

31. OraQuick QC checklist:
Look at the temperature log
Look at the testing log
Is this a new shipment?
Is testing anonymous?
Check reagent storage thermometer
Run quality control
Invalid client results
Monthly quality control
Look at the temperature log. If it is not yet filled out for today:
Record the reagent storage temperature and reset the thermometer. If out of range, proceed to step 6 and run quality control (Reason 2)
Record the refrigerator temperature and reset the thermometer. If out of range, indicate on the back of the log what you did to fix the problem.
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 6 and run quality control tests (Reason 5)
Were control samples run on Monday? If not, proceed to step 6 and run quality control tests (Reason 1)

32. OraQuick QC checklist:
Look at the temperature log.
Look at the testing log
Is this a new shipment?
Is testing anonymous?
Check reagent storage thermometer
Run quality control
Invalid client results
Monthly quality control
Is this the first box of a shipment of reagents?
If yes, proceed to step 6 and run quality control tests (Reason 4)
For anonymous testing:
Were control samples run today? If not, proceed to step 6 and run quality control tests (Reason 3)
Check reagent storage thermometer.
If min or max temperature is out of range, run quality control tests (Reason 2).
Do this every time you get a test kit from the box…not just the first time.
Minimum
Maximum
Reset

33. RUNNING QC Running quality control:
On the testing log, record that you are running control tests, and why you are running them.
Put the control lot number in the Identification column.
Don’t open a new box unless the old one is expired
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).

34. RUNNING QC Running quality control (continued):
If the control results are not what they should be, or if they are invalid, repeat the test:
Use a new box of controls
Date the new box:
When opened
When it expires (21 days later)
Use reason 6 when you repeat the controls
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.

35. 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

36. Coordinators
Review counsellor quality control rotation before the end of the month
Add QC reason 7 once for each counsellor, each month

37. 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
Minimum
Maximum

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

39. 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?)
Monitor reasons for runnng QC
PT monitoring (Competency assessment tool)
Problem logs (What happened?)
Logs will be reviewed centrally each month
CDC study of how many controls are needed

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. Testing Logs Check Expiration dates
Record QC, PT, client testing in the log
Record temperature, internal QC
Record reasons for running QC
Record reagent and QC lot numbers
Check the temperature and testing logs before running a test, to see if QC is needed
For OraQuick Advance, record whether oral or blood
Document any problems on the back of the log, with a note on the front
Site coordinators need to review them weekly
Sign legibly! (Name once per sheet, then initials, is OK)

42. Coordinator Responsibilities
Testing logs:
Review testing logs weekly
Review QC rotation before month-end
Send logs to us as each box is used

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

44. Why monitor Preliminary Positives?
Check OraQuick’s performance
Check appropriateness of confirmatory testing system (phlebotomy vs fingerstick)
Follow-up if confirmation is negative (part of CDC study)
This is new to all of us

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

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

47. 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

48. 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.

49. Notification Phone: 732 235-8112 (Franchesca Jackson)
(Dr. Martin) -
Cell Phone – Dr. Martin (732)
If you don’t need a response immediately works best for all of us – it provides a record of the call and can’t get lost!

50. Orasure Oraquick HIV
Details of Testing

51. Orasure OraQuick Qualitative HIV
Check Quality Control checklist
Check expiration dates!!
Once opened, 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.

53. 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.

54. 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 (toward the thumb).
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.

55. Oraquick Qualitative HIV Antibody
Replace with instructions for oral testing

56. 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.

57. 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.

58. 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.

59. 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

60. 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?

61. 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!! (but record it on the form)

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

63. REPORTING GUIDELINES:
All testing results must be in 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,check 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 when completed.
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.

64. Testing & Daily Checklists
Checklists/Summary
Testing & Daily Checklists

65. 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)

66. Checklist for 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

67. Coordinator responsibilities
Inventory control
Weekly
Review testing records
Monthly:
Competency review
Problem solving
QA indicators
Call us if confirmatory test is not positive

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

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

70. How We’re Doing? – The Monthly Site Visit -
Documentation tells the story – “An Open Book Exam”
Review the logs
Testing Log
Temperature Logs
Is everybody doing QC periodically
Does the lab respond appropriately when corrective actions are needed (Temperature out of range, Reagents Expired)?
Is there evidence of supervisory review?
Is everybody certified… and is it current?
How is the laboratory performing on Proficiency Testing?
How about ongoing Competency Assessment?