ASCP Weighs in on CLIA Personnel Regulatory Changes

Publication Date: Mar 29, 2019

The Clinical Laboratory Improvement Advisory Committee (CLIAC) recently heard from its personnel workgroup on possible changes to the Clinical Laboratory Improvement Amendments (CLIA) personnel requirements. The workgroup was tasked by CLIAC, as part of its November 2018 meeting, to consider “the educational requirements necessary for laboratory personnel, including possible use of competency exams/other key performance indicators, among other issues.

In a highly successful grassroots advocacy campaign, ASCP asked its membership to urge CMS to make four key changes to the CLIA personnel changes. CMS received over 8,000 messages, almost all of which urged CMS to make the following changes to the CLIA personnel rules: (1) allow an earned baccalaureate degree with at least 30 semester hours (or equivalent) of coursework in the clinical laboratory science/medical technology, biological science and/or chemical science to satisfy CLIA high complexity personnel academic requirements; (2) clarify that all high complexity testing personnel must complete clinical training; (3) establish personnel standards for histotechnology professionals similar to those for high complexity laboratory personnel; and (4) require all high complexity laboratory personnel to pass a national certification examination, such as that provided by the ASCP Board of Certification.

ASCP was present for the workgroup’s report and will provide an update on the meeting on April 24.

(This article was updated on April 17, 2019.)

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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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