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Laboratory Director Of Record - Definition

Please explain the title of 'Laboratory Director'.

Any examples are for illustrative purposes only.

Laboratory Director (LD) is the title afforded by regulation given to the individual whose name appears on the laboratory service's CLIA certificate. This individual is the Laboratory Director of record for Centers for Medicare and Medicaid Services (CMS) and Joint Commission purposes and they are responsible for all testing performed by the laboratory service. For non-waived testing, this individual is typically a pathologist. Other physicians or laboratory professionals may qualify if they have the prerequisite education and years of experience required by the federal regulations†. For waived testing, there are no federally defined qualifications for the Laboratory Director. In all cases, individual states may also have applicable regulations and licensure requirements for the Laboratory Director.

For the purposes of accreditation and CLIA records, the title of Laboratory Director should not be confused with the job description title of "Laboratory Director", sometimes given to an individual who provides administrative oversight of the laboratory. This is often an experienced laboratory professional with a Bachelor's or Master's degree. The Laboratory Director of record may delegate in writing a variety of oversight activities to the administrative director, including technical responsibilities, in accordance with their qualifications and as permitted by regulation.

Qualifications for the Laboratory Director of record for non-waived testing are described in the Clinical Laboratory Improvement Amendments under Subpart M: "Personnel for Nonwaived Testing," 493.1351 - 493.1495.
Manual: Behavioral Health
Chapter: Waived Testing WT
First published date: April 11, 2016 This Standards FAQ was first published on this date.
This page was last updated on October 28, 2021

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