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Waived Testing -Laboratory Director Qualifications

What are the suggested minimum qualifications for the Laboratory Director on a CLIA Certificate of Waiver?

Any examples are for illustrative purposes only.

For waived testing, there are no federally defined qualifications for the Laboratory Director in the Clinical Laboratory Improvement Amendments (CLIA). The individual should have the technical knowledge and experience required to oversee the specific laboratory testing performed.

The Joint Commission further recommends that the individual at least meet the minimum qualification route otherwise defined in the CLIA regulations for moderate complexity testing personnel [42 CFR 493, Subpart M]. Individual states may also have applicable regulations and licensure requirements for the Laboratory Director. Note that the Laboratory Director is legally responsible for all testing performed under the CLIA certificate. Non-physicians serving as Laboratory Director should seek professional advice regarding the necessity of additional professional liability insurance.
Last updated on March 17, 2021
Manual: Critical Access Hospital
Chapter: Waived Testing WT

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