CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Anne Ford
March 2016—If a laboratory does not perform its proficiency testing in accordance with a recently reiterated CMS directive regarding PT on multiple instruments, its standing with the Centers for Medicare and Medicaid Services could be at stake. In fact, “You could be sanctioned directly by the CMS,” says Thomas Long, MPH, CAP director of biostatistics.
The July 2015 directive—which states that laboratories are not permitted to test PT samples on multiple instruments unless that is how they routinely test patient specimens—is not exactly new. Under CLIA regulations, a laboratory must treat a PT specimen just as it does a patient specimen. “It’s always been around,” says Linda Palicki, MT(ASCP), CAP director of continuous compliance. “It’s just that in July, CMS clarified that this restriction applies also to nonregulated analytes and to analytes categorized as waived under CLIA.” For CLIA-regulated analytes, PT providers in 2014 removed from PT result forms the option to report secondary instruments or methods.
Since last fall, Palicki and other CAP staff have received questions from laboratories that are concerned about inadvertently violating the directive. “We are still hearing from laboratories asking, ‘What do I need to do? I have multiple departments that are under one CLIA and CAP number, so how will I approach my PT? And if I want to check my other analyzers, what are my best options?’”