For molecular testing of direct specimens, CMS considers bacteriology, virology, and yeast in blood cultures to be regulated tests. If the only regulated bacteriology, virology or mycology testing you perform is using a multiplex analyzer, you are required to participate in five challenges, three times a year for compliance with CLIA.
Frequently asked questions
If I perform antigen, culture, and molecular testing, do I need to enroll in proficiency programs for each one?
PT enrollment needs to cover both antigen and identification testing (culture or molecular). The extent of coverage for each is up to your laboratory director and regulatory agency. However, many of our laboratories will enroll in a proficiency program that will allow them to test and report results for each assay that can be performed on a patient sample. For example, when testing for Streptococcus pneumonia many laboratories have antigen and molecular testing options available and will enroll and report in a separate proficiency program for each.
What analytes are included in the molecular multiplex programs and am I required to cover all targets/pathogens in my multiplex panel?
A list of analytes included in each of our molecular multiplex panels is included in our current catalog.
You will need to verify through some format that you are accurately identifying the targets included on your multiplex panels, but this is not limited to proficiency testing. If an analyte is not included in our program, you may perform an alternative assessment to document the accuracy and reliability of that analyte.
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With API’s DataDirect proficiency results are uploaded using your LIS. This upload eliminates the main cause of PT failures- clerical errors.
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