January 2009
PAP/NGC Programs Review

Barbara Blond, MT(ASCP), MBA

All laboratories that are using molecular methods to test human papillomavirus are required to have a license for testing and to participate in annual proficiency testing for HPV, per the Clinical Laboratory Improvement Amendments of 1988. Laboratories that do molecular testing for HPV but do not participate in a general virology proficiency test are required to participate annually in three events, each consisting of five challenges.

The reference for this requirement is CLIA, subpart H, section 493.831 Standard; Virology at http://wwwn.cdc.gov/clia/: “Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance,” and “Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event.” Subpart I, section 492.919 outlines the proficiency test provider responsibility: “To be approved for proficiency testing in virology, a program must provide a minimum of five samples per testing event. There must be at least three testing events at approximately equal intervals per year.”

The CAP human papillomavirus Survey, CHPV, meets the CLIA requirement for a program of three events and five samples per event. It is the only HPV proficiency test available in the United States that is specific to transport/ preservative media type. The purpose of this qualitative Survey is to determine presence or absence of high-risk HPV. The participant is required to take the samples through preanalytic, analytic, and postanalytic steps. This enables laboratories that use cell lysis as part of their procedure to test this step. Testing all phases ensures the accuracy and reliability of test results.

Four different modules of CHPV make it possible for the laboratory to choose the sample type(s) it wants to receive. Only laboratories that receive all three sample types should enroll in CHPVJ.

The CHPV-A mailing ships on March 30. To enroll in the CHPV Survey, please contact CAP customer service at 800-323-4040.