Robert Wood Johnson Medical School

Point of Care Testing

Program

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

• LABORATORY– Document QC practices

• 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

• Where we are currently - • What the Post-Marketing Surveillance will mean for

you• What new tools will be put in place in the laboratory to

achieve these objectives

Introduction

Principle• Minimize the number of forms • Maximize the information on each form• Refine the process as we go along

Testing sitesOngoing Responsibilities

• 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?

• 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

Patient Test Log (Revision)

New Column

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. CONFIDENTIAL 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

PMS ProtocolOraquick Quality Control Log Sheet

• If performed by an individual site QC log will include:

– Date– Counselor Number– Lot Number– Control Expiration Date– Date Control was Opened– Results– Number of Tests between controls– Reasons for doing control

• New OperatorExpired

Control• Change in Environment Other• Daily Quality Control

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: - cadoff@umdnj.edu– martineu@umdnj.edu

• 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.– If min or max temperature is out of range, proceed to step 2, but then

run quality control tests.

2. Look at the temperature log.– 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. – 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)

4. Is testing confidential?– 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:– 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– 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.

– 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.