CLIAC Supports Majority of ASCP Proposals on Personnel Standards

ASCP Pleased CLIAC Recommendations are Consistent with Reversing CMS Nursing Degree Policy, Establishing Personnel Standards for Histotechnology Professionals

The Clinical Laboratory Improvement Advisory Committee (CLIAC) met April 10 to consider changes to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) personnel rules for high and moderate complexity. Many of CLIAC’s recommendations closely follow recommendations from ASCP and the ASCP Board of Certification (BOC), which were presented at the meeting by Barbara Caldwell, MS, MASCP, MLS(ASCP)^CMSH^CM. The CLIAC meeting largely followed the recommendations of its CLIA Regulations Working Group, chaired by ASCP Past President Lee H. Hilborne, MD, FASCP, MPH, DLM(ASCP)^CM. ASCP BOC Board of Governors Chair Susan Harrington, PhD, D(ABMM), MLS(ASCP)^CM, was also a member of this CLIAC Working Group.

One of the major issues considered by CLIAC concerns is which baccalaureate degrees should be required of high complexity testing professionals. Currently, CLIA requires individuals who qualify on the basis of a baccalaureate (or higher) degree to have that degree “in a chemical, physical, biological or clinical laboratory science or medical technology.” Of course, this language has been contentious lately, as the Centers for Medicare and Medicaid Services (CMS) opined that nursing is a biological science.

ASCP and the BOC’s statement to CLIA recommended that all individuals, including those who may have “non-traditional” degrees, should have at least 30 semester hours of academic credit. CLIAC agrees with this position in principle, though it has not formally settled on a specific credit-hour requirement. In adopting this position, CLIAC acknowledged that qualification by degree was always a surrogate for having the appropriate requisite courses and agreed that physical science should be removed from the list of acceptable degrees, because those degrees may not contain sufficient science courses necessary to ensure quality laboratory testing. This position could also apply to nursing degrees, meaning that CLIAC’s general position is that a nursing degree alone is not equivalent to the biological sciences. ASCP, which has been working hard to remove nursing as an acceptable academic degree for performing high complexity testing, applauds CLIAC for this recommendation.   

One concern voiced during the discussion was how to determine if non-traditional degree holders have sufficient coursework in the relevant sciences, which could be burdensome on laboratories, laboratory inspectors and laboratory professionals. Ms. Caldwell noted in her statement that the ASCP BOC certification process assesses whether an individual has completed enough of the coursework necessary for quality testing. ASCP recommended that CMS recognize the ASCP BOC and its certification programs as primary source verification to ensure that appropriate coursework has been completed. This would allow CMS to both expand the potential labor market of clinical laboratory testing professionals and minimize the burden of documenting credentials for laboratory personnel. This would also reduce the burden of the annual CLIA requirement that clinical laboratories must document the competencies and credentials of laboratory testing professionals.

In addition, ASCP has recommended, and CLIAC has supported, establishing personnel standards for histology professionals similar to those for high complexity testing personnel. ASCP worked with the National Society for Histotechnology to push CMS and CLIAC to support the establishment of personnel standards for the histology profession. ASCP will continue to work with CLIAC and CMS as the Agency works toward revising the CLIA personnel regulations. To access a copy of the CLIAC CLIA Personnel Regulations Working Group report, click here.

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