Transcript Document 7166150

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
Status Report – February, 2004
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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.
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Website:
 A URL has been secured (http://www.njhiv.org)
 eMail for all sites will be provided
 Site activation is anticipated – February, 2004
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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
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Site Visits:
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Route #1:
Route #2:
Route #3:
Route #4:
Route #5:
April
May
June
July
August
Sept
4/7
4/14
4/16
4/21
4/28
5/5
5/12
5/19
5/21
5/28
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
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
Basic Elements of Laboratory Training
• Quality Assurance Plan
• Bloodborne pathogen training
• OraQuick Testing, including
• quality control
• reporting requirements
• Confirmatory Testing
• Supervisory oversight
Elements of Quality Assurance
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Competency Assessment and Operator Certification
Quality Assurance
Quality Control
Proficiency Testing
Test records (Patient, QC, PT)
Inventory control
Temperature logs
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
Coordinator responsibilities
Quality Assurance
• Inventory control
• Monthly:
– Review testing records
– Competency review
– Problem solving
• QA indicators
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
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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.
Coordinator Responsibilities
Competency Reassessment
• 6 month reassessment
• Annual reassessment
• Monthly QC
• Internal PT (at monthly visits)
• Direct observation (at monthly visits)
• Written test
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
Responsibilities of the Counselors
Quality control
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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
Coordinator Responsibilities
Quality Control
– Check QC log weekly
– Each operator must run QC at least once a month
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
Responsibilities of the Counselors
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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!
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 $$)
Responsibilities of the
Counselors
• 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 Fran
• Fran 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
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
Coordinator Responsibilities
Temperature Control:
• Review temperature logs weekly
• Send logs to Fran monthly
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
Responsibilities of the
counselors
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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)
Coordinator Responsibilities
Testing logs:
• Review testing logs weekly
• Review QC rotation before month-end
• Send logs to Fran monthly
Why monitor Preliminary
Positives?
• Check OraQuick’s performance
• Check appropriateness of confirmatory
testing system (phlebotomy vs
fingerstick)
• 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 Fran
• When confirmatory result is back, add it
to the form and send/fax it to Fran
Coordinator Responsibilities
Preliminary Positives:
• Make sure Prelim Positive forms are
completed and faxed to Fran
• Phlebotomy services should be made
available (counsellors? contract?)
LABORATORY TRAINING
General Concepts
Orasure Oraquick HIV
Details of Testing
Orasure OraQuick Qualitative HIV
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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
subject’s name or ID.
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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
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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.
Oraquick Qualitative HIV Antibody
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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!
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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
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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 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!!
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
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
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
Someone who completes training
and competency assessment today
performs the CAP prelicensure
survey the week of Feb 9!
When the state
(CLIS) gives the
go-ahead, you’re
ready to test!