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|Department of Health

Diagnostic Immunology/HIV Proficiency Testing Program

Frequently Asked Questions

What are the specimens used in the DI/ HIV proficiency tests? What's the requirement for storage?: All DI/ HIV PT samples are human sera. They should be refrigerated on receipt.
What should we do if the laboratory director is not available to sign the proficiency test results form before the postmark deadline?: The laboratory should retain a copy of the result form and send the unsigned original form in by the postmark deadline along with a note of explanation. The copy should be signed by the director as soon as possible and then sent in to the PT section.
What should we do if the laboratory can not process the samples for an analyte before the postmark deadline?: If for some reason the laboratory is unable to process the samples for an analyte before the postmark deadline the laboratory should notify the PT section prior to submission of test results. The PT section will make the determination WHETHER OR NOT to excuse the laboratory from the analyte it can not test in the current test event.
What is the method of shipment used to deliver the DI/ HIV PT samples to laboratories?: The DI/ HIV PT samples are shipped by FedEx standard overnight. You must notify us by phone/email if you do not receive your PT package by the afternoon after the shipment.
Why does my laboratory receive result form(s) for the analyte(s) we never test?: With over 450 laboratories participating in the diagnostic immunology and HIV proficiency test, there is a wide variety of laboratory testing protocols. At this time it is not feasible for us to offer result forms which are customized for each laboratory. Please check the small check box following the analyte name on your result form for any analyte that is not listed on your laboratory's DI/ HIV permit(s).
What is the procedure for adding/ deleting an analyte from my laboratory's existing permit?: If you need to add or delete an analyte from your protocol, you will need to complete the "Notification to Add/Remove Analytes" form (PDF -- 88K ) located at the CLEP website or by calling CLEP at 518-485-5378.
Proficiency testing and an on-site survey are no longer required prior to the addition of an analyte to an existing permit category. If the analyte is subject to New York State proficiency testing, the laboratory will be enrolled in the next regularly scheduled event. In most case, assay method validation for the new analyte will be reviewed during the next routine survey; however, validation data and/or standard operating procedure manual may be requested for reviewing by the Department of Health.
Notification of category/analyte deletion must reach the Department at least two weeks prior to a scheduled proficiency test event to avoid affecting test grading. Failure to notify the Department within the specified time frame may result in a score of zero.
Can I use my result form for the purpose of adding/ deleting an analyte from my laboratory's existing permit?: No. The result form is designed to be used for reporting your laboratory's PT results. If you write the request for adding or deleting analyte(s) on your laboratory's result form your request will not be processed by CLEP. For the procedure for adding or deleting analyte(s) please refer to the answer of the previous question.
What does "Test sample was not authenticated" mean?: It means the test sample could not be graded (scored) by the PT program for reasons unrelated to the laboratory; e.g., the sample gave inconsistent results among participants or the required 80% consensus could not be reached among participants and, by regulation, the sample can not be graded (scored). In this case every participating laboratory will get a credit for the unauthenticated sample they tested.