robert wood johnson medical school hiv point of care testing program umdnj – robert wood johnson...

Robert Wood Johnson Medical School

HIV Point of Care Testing

Program

<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



• 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!


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


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


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


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”

1. It is the FIRST DAY of a new testing week2. STORAGE TEMPERATURE is out of range3. ANONYMOUS testing MAY be performed today4. NEW SHIPMENT has arrived5. An INVALID RESULT was obtained6. QUALITY CONTROL failed7. Coordinator assigned MONTHLY QC testing to you8. OTHER – e.g.You are uncomfortable for whatever reason

OraQuick QC checklist:1.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.

2.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)

CHECKLIST1. Look at the temperature

log 2. Look at the testing log 3. Is this a new shipment?4. Is testing anonymous?5. Check reagent storage

thermometer 6. Run quality control7. Invalid client results8. Monthly quality control

OraQuick QC checklist:

3.Is this the first box of a shipment of reagents?– If yes, proceed to step 6 and run

quality control tests (Reason 4)4.For anonymous testing:

– Were control samples run today? If not, proceed to step 6 and run quality control tests (Reason 3)

5.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.

CHECKLIST1. Look at the temperature

log. 2. Look at the testing log 3. Is this a new shipment? 4. Is testing anonymous? 5. Check reagent storage

thermometer 6. Run quality control7. Invalid client results8. Monthly quality control

Minimum

MaximumReset

RUNNING QC

6. 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

6. 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)


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


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: - [email protected]– [email protected]

• 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.


• Replace with instructions for oral testing


• 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, 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

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• 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 CoordinatorsWeekly: Review and sign logs (temperature log

and test records) weeklyMonthly: Review QC rotation before month-end Send logs to us Check for recertifications duePeriodically (per calendar): Expect CAP PT samples Make sure CAP PT results are faxed inAs 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?

robert wood johnson medical school hiv point of care testing program umdnj – robert wood johnson...

Documents

testing personnel

track of counsellors

cts sitesgoals

delivery of reagents

additional visits

training sessions

laboratoryfollow manufacturers

national normsreviewed