Is it illegal to refer proficiency testing samples to other labs?

Q: Is it illegal to refer proficiency testing samples to other labs?

A: The Centers for Medicare and Medicaid Services (CMS) has been paying increased attention to proficiency testing (PT) referrals in which a lab sends all or part of a specimen to another lab for analysis, or communicates with another lab about results, both of which are in violation of Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) rules.

CLIA regulations and CAP instructions for proficiency testing state that laboratory technicians must test proficiency samples in the same manner as regular patient specimens. CLIA surveyors are finding a surplus of cases in which labs are in violation of PT rules. CLIA requires a lab technician who receives what appears to be a PT sample from another lab to notify CMS.

Many labs may be inadvertently breaking CLIA and CAP rules. The technician conducting PT has to recognize and adhere to the rule that PT samples should be treated as though they are patient samples, and that neither the samples nor the results should be shared. In addition, PT samples should only be tested the same number of times that patient samples are tested, and should be tested on the lab's primary test system.

Even if a violation is accidental, the lab director may be held accountable for it. CMS has the ability to revoke a lab's CLIA certificate for one year if it finds violations of proficiency testing rules, and this can include the loss of Medicare and Medicaid payments. CMS also can prohibit a lab's director from directing any laboratory for two years.

To prevent PT violations, make sure staff is aware of and understands the rules that govern PT referrals. Be sure to have policies in place to make sure PT samples aren’t mishandled, and that lab employees are appropriately supervised. 

For questions about PT samples, email ppm1@aad.org.

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