ASCP and the BOC Advocate for Better CLIA Personnel Standards

Publication Date: Nov 12, 2019

In a November 5 statement to the Clinical Laboratory Improvement Advisory Committee (CLIAC), ASCP and the ASCP Board of Certification (BOC) advocated that CLIAC push the Centers for Medicare & Medicaid Services to release proposed regulations to update the Clinical Laboratory Improvement Amendments of 1988 (CLIA) personnel standards. In that statement, ASCP reiterated its past recommendations that CLIAC urge CMS to make the following important changes to the CLIA personnel requirements:

Change the baccalaureate degree requirements to ensure that all laboratory professionals have sufficient knowledge of the sciences relevant to laboratory testing. (This would require individual who do not have a bachelor’s degree in biology, chemistry or medical technology/medical laboratory science to have at least 30 semester hours of academic science relevant to laboratory medicine);
Ensure that all personnel have training appropriate for the testing they perform;
Establish personnel standards for histotechnology professionals similar to those for high complexity testing personnel;
Require CMS to establish standards to recognize laboratory personnel certification agencies, such as the ASCP Board of Certification, as primary source verification entities that can verify the academic and clinical training of laboratory personnel; and
Require all laboratory personnel performing high complexity testing to be certified by a recognized laboratory professional certification agency, like ASCP.

In addition to pushing for better personnel standards in CLIA, ASCP provided comments to CLIAC on the roles, responsibilities and competencies of bioinformaticists. ASCP recognized these important members of the laboratory team. ASCP supported the idea and offered its technical expertise toward conducting a comprehensive bioinformatics workforce survey to help CLIAC to better understand the vital roles these professionals are providing to improved patient care.

CLIAC is a federal advisory committee established to provide expert guidance to the Centers for Medicare & Medicaid Services, Centers for Disease Control and Prevention and the Food and Drug Administration on matters relating to the CLIA oversight of clinical laboratories.

Other articles in the November 2019 ePolicy News: