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

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

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

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

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

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

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

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

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

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

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

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

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

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 (866-420-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!

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

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

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

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

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

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

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

Temperature Monitoring

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

Temperature Log POCT HIV Temp Log (ONLY) - PDF

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

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

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

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

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

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

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)

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

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).

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.

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

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

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

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

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

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

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)

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

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

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

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

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

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

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.

Notification Phone: 732 235-8112 (Franchesca Jackson) 732 235-8114 (Dr. Martin) Email: - cadoff@umdnj.edu martineu@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!

Orasure Oraquick HIV Details of Testing

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.

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.

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.

Oraquick Qualitative HIV Antibody Replace with instructions for oral testing

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.

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.

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.

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

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?

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)

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

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.

Testing & Daily Checklists Checklists/Summary Testing & Daily Checklists

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

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

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

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

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

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?