Transcript No Slide Title

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
GOALS FOR TODAY
• STATUS REPORT:
• LABORATORY TRAINING
– GENERAL OVERVIEW:
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QC Principles
Logging
Reporting
Proficiency Testing
Troubleshooting
– BLOODBORNE PATHOGENS
• IMPLEMENTATION TRAINING:
– HIV ORASURE Oraquick
CONCEPT REVIEW
Distribution of Responsibilities
Central POCT responsibilities
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Annual:
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Monthly visit:
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3-4 times per year:
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As needed:
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Personnel forms
License
CLIA registration
Order Proficiency Tests
Competency assessment
Collect and evaluation PT results
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Refresher/new-hire training:
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Monthly review:
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Test logs
Temperature logs
Inventory
Internal proficiency testing
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Delivery of reagents and supplies
Review testing records
Competency review
Problem solving (additional visits as
needed)
Reagent validation
State inspection
Preliminary positive follow-up
Troubleshooting
Responsibilities of the Testing
and
Counseling Centers
Licenses
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Personnel forms
Coordinator contact information
Correct address
Quality control
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Procedures
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Read them
Read manufacturer’s package insert
Follow them!!
Procedures for preliminary positives
Check reagents
Check reagent storage
Check operator proficiency
On-board and external (liquid)
controls
Proficiency Testing
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External audit of performance
Reviewed by state for licensure
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Once pre-licensure
3 times per year: CAP
Monthly, POCT program
All PT tests/results through POCT
office
STATUS REPORT
Status Report –
• Limited Purpose Laboratory Regulation and Health Care
Emergency
• Licenses:
– Applications
√ Licensed sites 1 – New Brunswick
√ Applications completed 13
√ NJ Site visits have occurred at all sites
 One site has withdrawn - RBMC
 One application is incomplete
 Three licenses are being held because of an inadequate number of
trained personnel – Being addressed today and tomorrow
 CLIA registration has been submitted for all licensed sites
• Implication:
 Anticipate ‘Go Live’ at all sites this week
 Satellite sites will come on line this summer
What is a satellite site?
• A satellite site is, at least at the outset, a fixed
location that will be serviced by the same
group of personnel who have been trained
and qualified through the primary lab
• A satellite must use the same procedures, the
same personnel, the same QA program as
the primary site
• Because personnel are proficiency assessed
at the primary site, the site is not required to
separately perform proficiency testing.
What will we need to do?
• We have already been provided list of satellites being
serviced by each primary site
• We are currently establishing procedures which will
tell you how we will bring up a satellite and what
arrangements will need to be made:
– Transportation of supplies vs secure storage
– Quality Control issues related to reagent monitoring (e.g.
temperature of devices/controls
– Record keeping
– Site assessment
• Time frame – months - starts later this summer
Status Report – May, 2004
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Written Procedures
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All 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 has ALL current forms and procedures available
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Training:
 Today – At the end of training we anticipate you will be prepared to participate in
testing, quality assurance and proficiency testing
 Additional training:
 South – Tomorrow
 North – ?
 Central – Today
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Tentative Site Visit Schedule:
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Route #1:
Route #:
Route #3:
Route #4:
Route #5:
June
July
August
Sept
6/2
6/9
6/16
6/18
6/28
7/7
7/14
7/16
7/21
7/28
8/4
8/11
8/18
8/20
8/24
9/1
9/8
9/15
9/17
9/28
LABORATORY TRAINING
General Concepts
Basic Elements of Laboratory Training
• Training - Laboratory & Bloodborne Pathogens
• Reagent supply and validation
• Quality Control and Quality Assurance Procedures
• Reporting requirements
• Proficiency testing & Competency Assessment
• Supervisory oversight
What is Quality Control?
• Elements:
– 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.
– What happens if there is a problem Records
that permit follow-up by lot and by patient
– Do operators perform testing properly?
 Annual operator certification. Biennial certification in
Year One
– Are transport and storage conditions satisfactory?
 Temperature records. Transport containers and
conditions.
Our Quality Assurance Program
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Participation in Interlaboratory comparison programs:
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Internal Laboratory quality control program:
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CAP Proficiency testing
NJ DOH - Proficiency Testing Program
AAB - American Association of Bioanalysts
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Why?
• Provide for a comprehensive process for review of QC data and the release of results
• Provide a mechanism for the review of inconsistent findings by laboratory professionals
Elements:
• Daily procedures, including:
– Generation of mandated QC
– Generation of daily laboratory reports in a consistent, retrievable manner
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Periodic Meetings of the POCT oversight committee.
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Purpose:
Review ongoing technical problems and their resolution
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Review problem cases
Review of proficiency testing performance
Review customer service issues
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Quality Assurance Indicator Program
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Formal Education and Competency Assessment Program
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On a quarterly basis, quantitative indicators that reflect identifiable issues of quality are collected.
Acceptable performance is decided in advance and reviewed..
Elements of Quality Assurance
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Quality Assurance Logs
Test records
– QC results
– PT results
– Competency Assessments
– Inventory control
Temperature logs
Preliminary positive test log
Reagent/supply ordering
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Competency assessment
Initial training (all elements above)
6 month reassessment
Annual reassessment
Monthly internal PT and observation
Training/Competency
assessment
Review procedures
Review QA plan
Run QC
Run Proficiency Testing
Examiner observations
Written test
CONCEPT: Proficiency Testing Program
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External unknowns are received from CAP
Analyzed by testing personnel as they would a patient specimen
Results are returned
Six to eight weeks later nationwide results are received:
– Good
– Acceptable
– Unacceptable
• Unacceptable results require a Deficiency Response to be
returned to CAP after an investigation into the failure
SPECIFICS: Proficiency Testing Program
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Specimens will be sent to you directly from the College of American
Pathologists (CAP) during the weeks of:
– Feb. 9, 2004 – THESE WERE YOUR PRE-LICENSURE RESULTS!
– May 3, 2004 – Recently completed.
– Sept 20, 2004
If specimens are not received within 5 days of these dates we should be notified!!
Tight time frame
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Fran Jackson will generate an email reminding you of this a few days before
each shipment
These specimens should be received by each site and be tested promptly
CAP proficiencies contain an attestation that the test has been performed as
you would a patient specimen – THIS NEEDS TO BE SIGNED BY THE
INDIVIDUAL PERFORMING THE TEST!!
Results are to be reported back to our office within 5 days by fax set to FINE or
EXTRA FINE!!
Dr. Cadoff will sign off on these centrally and we will relay them to CAP
An individual who successfully participates in a PT event will be recertified!
Supervisory Review
• Coordinator’s MUST review all testing
performance – weekly!
– Signature and Date on the testing log.
– DO NOT backdate should you fail to review testing
at your site.
• Monthly – Send/Fax copies of your logs to us
• UDL professional staff will review monthly for
completeness and correctness
– Evidenced by signature and date on testing log
Orasure Oraquick HIV
Details of Testing
Orasure OraQuick Qualitative HIV
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Quality control is essential. External Quality Control MUST BE PERFORMED.
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THIS INCLUDES:
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With each new shipment of reagents
At the beginning of each week
Each month, by each person doing testing
Whenever there has been a change in the test environment – room or storage
When Temperatures have exceeded manufacturer’s specifications: 2°–27° C (35° – 80°F)
A new testing location is being utilized
Room lighting has been significantly altered
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 subject’s name or ID.
Be careful not to block or cover the two holes on the back of the test device.
Remove the cap from the vial, making sure that you are wearing disposable gloves.
Expiration Dating
• Single biggest problem in POCT testing
– Expiration dating varies based on reagent or control solution
– Refer to the UDL sheet or the manufacturer’s package insert
– IT MATTERS!! Why?
HIV reagents:
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Expiration of control reagents – 21 days after opening!!
Kits – Storage requirements - < 80° F. If not, you must run QC to prove the
reagents are still performing properly
Storage of reagents
Oraquick Qualitative HIV Antibody
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Clean the finger of the person being testing with an antiseptic wipe, and allow it to dry.
Take a clean, unused Specimen Collection Loop, and fill the loop completely with blood.
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:
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PRELIMINARY Positive – Lines at T and C
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NEGATIVE – Line at C
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INVALID – No line at C – Do not report the result.
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Complete the testing log (whether test was successful or not).
If Quality Control is not correct, consult procedure manual. Do not test patients.
ORAQUICK HIV
Developer Solution
Specimen
Collection
Loop
Test Device
• KEY POINTS
– 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
developer vials – Mix
thoroughly THEN
– Add testing device and
begin timing.
Add specimen and mix!!
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
A 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!!
INVALID RESULTS
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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 Negative result
• A red control line
appears within the C
triangle.
• No other line, no
matter how faint
appears in the T
triangle
Checklists
Testing & Client
Testing Site Checklist I:
• Daily:
 Log Temperature checks:
 Refrigerator
 Room
 Reagent Storage
 Perform QC at a minimum:
 Every Monday
 Whenever new shipments are received
 Check QC rotation schedule to insure that all are participating
 Perform testing (see Client Testing Checklist)
 Fax all preliminary positives Fran at RWJMS (732) 235-8113
• Weekly
 Supervisory review of testing log sheets by site coordinator
Testing Site Checklist II
• Monthly:
 Inventory review  Fax Fran with needs prior to next visit
 Fax testing logs with evidence of weekly review  Fran
 Perform internal UDL proficiency testing during monthly visit
• Periodically
 Fax confirmed results to Fran at RWJMS (732) 235-8113
 Fax COMPLETED CAP proficiency test results:
 February 16, 2004
 May 10, 2004
 Sept. 27, 2004
 Respond to Proficiency Testing Exception Reports
 Download, duplicate and distribute REVISED procedures
 Site specific issues – as needed
Checklist for Client Testing
• Client Testing:
Check Expiration dates
Make sure QC is current
Use personal protective equipment
Label the vial AND the test device
Check for desiccant pack
Check the loop for complete filling
Read after 20 minutes, but less than 40
minutes
 All lines must be within the triangle!