CHA News Article

CMS Seeks Comments on Clinical Laboratory Personnel Requirements
Agency also addresses testing standards and industry fee structures

The Centers for Medicare & Medicaid Services (CMS) has issued the attached request for information on updating personnel requirements, testing standards and industry fee structures under the clinical laboratory improvement amendments. Among the personnel requirements listed, CMS seeks comment on whether it should codify in regulations the current guidance that a bachelor’s degree in nursing is considered equivalent to a bachelor’s degree in biological sciences for the purposes of educational requirements for moderate and high-complexity testing personnel under the clinical laboratory improvement amendments.

CMS notes that these regulations have not been meaningfully updated since 1992. The topics listed in the request for information are areas that the Centers for Disease Control and Prevention, state agency surveyors and other stakeholders have identified as needing to be updated to better reflect current knowledge and advancements in laboratory testing. CMS intends to consider public responses to the request for information when it drafts proposals to update the existing regulations. Comments are due March 12.

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