ASCP Seeks Clarification on CLIA Personnel Standards

March 03, 2020

On March 3, ASCP and the National Society for Histotechnology (NSH) wrote the Centers for Medicare and Medicaid Services seeking clarification about the Clinical Laboratory Improvement Amendment of 1988’s high complexity testing personnel requirements. Recently, ASCP and NSH has learned of several instances where CLIA inspectors may have incorrectly told laboratory staff that they lacked the qualifications necessary to perform certain high complexity procedures. In at least one situation, a histotechnician, who had an associate degree in histotechnology, was told they also needed to satisfy the course-specific requirements of 42 CFR 493.1489(b)(2)(ii)(A)(1) to gross anatomic specimens. This section of CLIA requires 60 hours of academic credit and 24 semester hours of academic science [For the specific course requirements, see here].

ASCP and NSH have written CMS arguing that this interpretation of the CLIA high complexity testing personnel standards is incorrect; per of 42 CFR 493.1489(b)(2)(i) of the CLIA regulations an associate degree in histotechnology is sufficient to gross anatomic specimens. ASCP and NSH argued that the course-specific section of the CLIA regulation cited by the laboratory inspector was a second, alternative pathway for laboratory personnel to meet the CLIA high complexity testing personnel requirements. ASCP plans to publish CMS’s response in a future edition of ePolicy, which should be useful as a resource to laboratory staff that encounters similar problems.

Other articles in the March 2020 ePolicy News:

To read more articles from ePolicy News click here.

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For more information regarding ASCP's advocacy initiatives and policy positions, please contact ASCP's Center for Public Policy at (202) 408-1110.

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