Virology Proficiency Testing Program

Frequently Asked Questions (FAQs)

1. How does a laboratory add a category to an existing permit?
   The laboratory must submit either a written request signed by the laboratory director or a notification form provided by the Department. The laboratory must complete a successful on-site survey and participate in one proficiency test event. In addition, method validation and/or SOPM review by the Department may be required.
2. What are the requirements for the addition of a new test or analyte to a permit category for which the laboratory is already approved?
   Laboratories adding a new analyte must submit either a written request signed by the laboratory director or a notification form provided by the Department. 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. Assay method validation and SOPM for the new analyte will be reviewed during the next routine survey. In addition, method validation and/or SOPM review by the Department may be required if the assay is not FDA approved, the intended use has been modified or is an inhouse developed or "home-brew." See submission guidelines for details.
3. What is the procedure for deleting a category or analyte from an existing permit?
   The laboratory must submit either a written request signed by the laboratory director or a notification form provided by the Department. 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.
4. What should we do if the laboratory cannot perform testing on the proficiency test samples in a panel before the postmark deadline?
   Failure to submit test results will result in a score of zero. Laboratories are responsible for using the Program's proficiency testing schedule to track shipment dates for test events in which they participate. However, the proficiency section may excuse participation in a test event if the laboratory has:
   
   
   1. Performed successfully in the two previous test events;
   2. patient testing has been suspended over the timeframe for the test events; and
   3. the Program has been notified of the temporary suspension of testing prior to the proficiency test event.
   
   Written notification signed by the director explaining your request for an excused participation should be sent to the Virology Proficiency Testing Program director.
5. What should we do if we fail an event?
   Should the laboratory perform unsatisfactorily in the category, the laboratory must investigate the cause of unsatisfactory performance and document the corrective action for review by the Program. The corrective action must be acceptable to the Program and performance in the subsequent test event must be satisfactory to meet proficiency requirements for the category.
6. How should the PT samples be stored?
   PT samples are shipped on dry ice via FedEx overnight delivery and should arrive frozen. Samples should be kept frozen at -70°C until testing.

NOTE: For further FAQs visit, http://www.wadsworth.org/labcert/clep/faq/faq.htm