Robert Wood Johnson Medical School

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 • 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

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

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

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

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

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

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) 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 OraQuick QC checklist:

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. 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 OraQuick QC checklist: 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

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

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

Robert Wood Johnson Medical School