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CHA has submitted the attached comment letter in response to the Centers for Medicare & Medicaid Services (CMS) request for information on revisions to the Clinical Laboratory Improvement Amendments of 1988 regulations. CMS — in consultation with the Centers for Disease Control and Prevention, state surveyors and other stakeholders – has identified a number of areas within the regulations that could be updated to better reflect current knowledge, changes in academic context and advancements in laboratory testing.
In the letter, CHA urges CMS to adopt regulations that provide the most flexibility for laboratory directors to make personnel decisions that address their workforce needs, based on an individual’s experience and educational background. CHA also supports giving CMS a greater level of discretion for Category 1 proficiency testing referral violations, particularly when sanctions are applied for laboratories following their standard operating procedures. In addition, CHA supports the recommendations of the Clinical Laboratory Improvement Amendments Advisory Committee Virtual Crossmatch Workgroup to update histocompatibility regulations, reflecting advancements in the field. Comments on the request for information are due March 12.
