Robert Wood Johnson Medical School

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HIV Point of Care Testing Program
Robert Wood Johnson Medical School
Eugene G. Martin, Ph.D.Evan M. Cadoff, M.D.,
BLD Associate Professors of Pathology and
Laboratory Medicine UMDNJ Robert W. Johnson
Medical School
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Status Report February, 2004

• Written Procedures
• Site-specific bloodborne pathogen procedures are
  needeed
• Letter of agreement with center owner is needed
  (more info to follow)
• All other procedures testing, reporting,
  administration, supervisory are completed.
• Website
• A URL has been secured (http//www.njhiv.org)
• eMail for all sites will be provided
• Site activation is anticipated February, 2004
• Training
• Today The person who completes training and
  competency assessment today performs the CAP
  Prelicensure survey
• Prelicensure visits (BEING ARRANGED NOW for
  MARCH) NJDHSS UDL
• Additional training (POSSIBLE DATES)
• South March 18th
• North April 1
• Central April 22
• Site Visits April May June July August Sept
• Route 1 4/7 5/5 6/2 7/7 8/4 9/1
• Route 2 4/14 5/12 6/9 7/14 8/11 9/8
• Route 3 4/16 5/19 6/16 7/16 8/18 9/15

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Status Report February, 2004

• Licenses
• Applications
• Licensed sites 1 New Brunswick
• Applications completed 15
• Prelicensure Issues
• Prelicensure discussion with CLIS. ?
  Simultaneous submission.
• Prelicensure survey scheduled week of Feb. 9th
  at all sites
• Licensure for HIV testing as soon as results are
  available from CAP
• CLIS to CMS for CLIA registration upon
  completion
• Implication
• Anticipate Go Live date in March for all sites

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Basic Elements of Laboratory Training

• Quality Assurance Plan
• Bloodborne pathogen training
• OraQuick Testing, including
• quality control
• reporting requirements
• Confirmatory Testing
• Supervisory oversight

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Elements of Quality Assurance

• Competency Assessment and Operator Certification
• Quality Assurance
• Quality Control
• Proficiency Testing
• Test records (Patient, QC, PT)
• Inventory control
• Temperature logs
• Preliminary positive test monitoring

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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

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Coordinator responsibilities

• Quality Assurance
• Inventory control
• Monthly
• Review testing records
• Competency review
• Problem solving
• QA indicators

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Training/Competency assessment

• Review procedures
• (we prepared them you read them)
• Review QA plan
• Run QC
• Run Proficiency Testing
• Examiner observations
• Written test

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Competency Reassessment

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

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Coordinator Responsibilities

• Training/Competency assessment
• Schedule counsellors for training sessions.

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Coordinator Responsibilities

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

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What is 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

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Responsibilities of the Counselors

• 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

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Coordinator Responsibilities

• Quality Control
• Check QC log weekly
• Each operator must run QC at least once a month

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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

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Responsibilities of the Counselors

• Specimens will be sent to you directly from the
  CAP during the weeks of
• Feb. 9, 2004 THESE WILL BE YOUR PRE-LICENSURE
  RESULTS!!
• May 3, 2004
• Sept 20, 2004
• These specimens should be tested promptly
• Sign the Attestation Statement
• Fax results back to our office within 5 days (fax
  set to FINE or EXTRA FINE!!)
• 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!

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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

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Why Inventory Control?

• Standardization of reagents and supplies
• Validation of reagents
• Replacement of supplies and consumable
• Bulk purchasing (save )

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Responsibilities of the Counselors

• Dont 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

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Coordinator Responsibilities

• Inventory Control
• Dont 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

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Why Temperature Control?

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

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Temperature Monitoring
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Responsibilities of the Counselors

• Record storage temperatures daily
• Refrigerator (controls) and Storage room
  (OraQuicks)
• Testing areas
• Reset Min/Max thermometers
• If storage temperature out of range, perform QC
• If testing area out of range, TEST ELSEWHERE

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Coordinator Responsibilities

• Temperature Control
• Review temperature logs weekly
• Send logs to Fran monthly

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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?)
• PT monitoring (Competency assessment tool)
• Problem logs (What happened?)
• Logs will be reviewed centrally each month

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Responsibilities of the counselors

• Check Expiration dates
• Record QC, PT, client testing in the log
• Record reagent and QC lot numbers
• Check the temperature and testing logs before
  running a test, to see if QC is needed
• Document any problems on the back of the log,
  with a note on the front
• Site coordinators need to review them weekly, and
  send them to Fran each month.
• Sign legibly! (Name once per sheet, then
  initials, is OK)

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Coordinator Responsibilities

• Testing logs
• Review testing logs weekly
• Review QC rotation before month-end
• Send logs to Fran monthly

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Why monitor Preliminary Positives?

• Check OraQuicks performance
• Check appropriateness of confirmatory testing
  system (phlebotomy vs fingerstick)
• This is new to all of us

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Responsibilities of the counselors

• Collect specimen for confirmation
• Phlebotomy preferred
• Fingerstick acceptable
• Fill out Prelim Positive form for all positives
• Fax the form to Fran
• When confirmatory result is back, add it to the
  form and send/fax it to Fran

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Coordinator Responsibilities

• Preliminary Positives
• Make sure Prelim Positive forms are completed and
  faxed to Fran
• Phlebotomy services should be made available
  (counsellors? contract?)

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LABORATORY TRAINING

• General Concepts

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Orasure Oraquick HIV

• Details of Testing

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Orasure OraQuick Qualitative HIV

• Check Test and Temperature log to see if QC is
  needed
• CHECK EXPIRATION DATES!!
• Once opened, Orasure External 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 subjects 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.

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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.

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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.
• 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.

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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 subjects 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.

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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..

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• 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.

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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

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INVALID RESULTS

• Red background interferes with interpretation
• No control line is visible
• Control line is outside C triangle
• Whats that at the top of the cassette?

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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!!

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A Negative result

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

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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 place 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 monthly.
• 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.

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Checklists/Summary

• Testing Daily Checklists

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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
• [phone]

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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

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Checklist for Coordinators

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

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To Do List for RWJMS and Coordinators

• Letter of agreement between RWJMS and site owner
  (including evidence of liability insurance)
• Bloodborne pathogen procedure, including
  emergency care plan in the event of exposure
• Phlebotomy arrangements

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Someone who completes training and competency
assessment today performs the CAP prelicensure
survey the week of Feb 9!
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• When the state (CLIS) gives the go-ahead, youre
  ready to test!