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Changes in CLIA Requirement for Processing Personnel

The College of American Pathologists (CAP) recently announced that it is changing its accreditation checklist for CLIA accreditation in response to an interpretation communicated by the Centers for Medicare and Medicaid Services (CMS) with regard to the qualifications for “processing” personnel. Previously CAP treated “processing” personnel different from “grossing” personnel and did not require “processing” personnel to meet the requirements for “high complexity testing.” Laboratory providers who previously relied upon the distinction of “processing” vs. “grossing” must now ensure that all personnel who perform macroscopic tissue examinations meet the educational requirements of 42 CFR §493.1489 or are grandfathered pursuant to 42 CFR §493.1489 or 42 CFR §493.1491. If personnel meet the requirements to be “grandfathered”, additional supervision requirements may apply.

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