Transcript No Slide Title

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
Franchesca Jackson, BS
UMDNJ – Robert W. Johnson Medical School
PMS OBJECTIVES
• GENERAL:
– Measure Oraquick utilization
– Test outcomes – number of
reactives/non-reactives
– Describe proportion of clients
who receive their results
– Seropositivity rate versus
‘conventional’ tests
– Adverse outcomes
• PROJECT DURATION 7/04
 12/04
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LABORATORY
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Document QC practices
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Frequency and reason for
running controls
Incidence of failed control
runs
Incidence and significance of
discordant confirmatory tests
Incidence and significance of
invalid test results
Introduction
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Where we are currently -
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What the Post-Marketing Surveillance will mean for
you
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What new tools will be put in place in the laboratory to
achieve these objectives
Principle
• Minimize the number of forms
• Maximize the information on each form
• Refine the process as we go along
Testing sites
Ongoing Responsibilities
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Log temperatures
Run & log QC
Log client tests
Run & log PT occasionally
Notify us of confirmatory tests
Get re-certified periodically
Why is Quality control needed?:
• Check reagents--they can deteriorate
• Check reagent storage--they can
deteriorate faster
• Check operator proficiency--their
memory or skills can deteriorate
The Patient Test Log
• Central document which oversees the laboratory’s performance
• Quality Control is documented every time it is performed
• New field is being added to the Patient Test Log: “Reason for
Performing QC”
Do you need to run controls?
Current Temp
• YES! – why?
• The storage area has
been too hot at some
point (93 °F)
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Storage Temperatures:
[35.6 °F  80 °F] (2-27 °C)
Minimum
Maximum
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Testing Temperatures:
[59 °F  80 °F] (15-27 °C)
Patient Test Log (Revision)
New Column
Codes to be used
“Reasons for Performing QC”
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2.
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5.
6.
7.
8.
It is the FIRST DAY of a new testing week
STORAGE TEMPERATURE is out of range
CONFIDENTIAL 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
PMS Protocol
Oraquick Quality Control Log Sheet
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If performed by an individual site QC log will
include:
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Date
Counselor Number
Lot Number
Control Expiration Date
Date Control was Opened
Results
Number of Tests between controls
Reasons for doing control
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New Operator
Change in Environment
Daily Quality Control
Expired Control
Other
Among the sites we oversee we have opted NOT to have
you complete the Quality Control Log sheet – we
will generate aggregate data from your patient test
log
If your laboratory is not operated by RWJMS, your
laboratory director will need to specify how you are
to provide this data to the CDC.
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
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.
• Basically,
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!
As you prepare to test a client with OraQuick, run through
this entire checklist:
1.
Check reagent storage thermometer.
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2.
If min or max temperature is out of range, proceed to step 2, but then
run quality control tests.
Look at the temperature log.
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If it is not yet filled out for today, record the temperature and reset the
thermometer.
If the temperature log is not filled out for today, also record the
refrigerator temperature and reset the thermometer. If the refrigerator
temperature is out of range, indicate on the back of the log what you (or
your coordinator) did to fix the problem.
If you need to run quality control tests from step 1, go to step 5 and do
that now (use reason 2).
3.
Look at the testing log.
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4.
Is testing confidential?
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Was the last test result in the log invalid? If so, find out who’s working on the
invalid test, or proceed to step 5 and run quality control tests (use reason 5)
Were control samples run on Monday? If not, proceed to step 5 and run quality
control tests (use reason 1)
If yes, were control samples run today? If not, proceed to step 5 and run
quality control tests (use reason 3)
If you do not need to run quality control for any reason above, run the client
test according to the testing procedures you have learned. If you get an
invalid result, see step 6.
5.
Running quality control:
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On the testing log, record that you are running control tests, and what
the reason is.
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).
If the control results are not what they should be, or if they are invalid,
repeat the test
If you need to repeat the test, use a new box of controls if you have
them, and throw out the old ones.
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.
6.
Invalid client results
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If you get an invalid result on a client, enter the invalid in the log. On
the back of the log write why the test was invalid (for example, “No C
line” or “Lines not inside the triangle” or “No lines”)
Complete the invalid test report form
If the client agrees, repeat the test.
If the result is invalid twice, run quality control (reason 6) before running
another client.
If the client doesn’t want to be tested again, run control samples
(reason 5)
Don’t leave the test log with an invalid result as the last entry
7. You need to run quality control samples at
least once each month.
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If you notice that it’s near the end of the month, or
your coordinator asks you, run your monthly quality
control samples using reason 7.