to main content Laboratory Director Of Record - Definition | Home Care | Waived Testing WT | The Joint Commission
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: Home Care
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
Was this response helpful?

If no, please comment on how we could improve this response.

If you have additional standards-related questions regarding this topic, please use the Standards Online Submission Form

Get Extra Help with Books and E-books

Browse our gallery of books and e-books to find trusted prep and readiness resources, practical checklists and toolkits, and resources on specialized health care topics.

Stay Informed with Online Education

Online education is the most convenient and cost-effective way to educate your staff and minimize expenses without the need to leave your organization.

Reach Your Safety Goals with eProducts

Assessing and sustaining compliance with accreditation standards or CMS CoPs can be a challenge, but it doesn’t have to be. Rely on our proven software solutions developed by our team of industry experts.

Can't Find What You're Looking For?

If you do not find an answer to your question, please contact the Standards Interpretation Group (SIG).

Note: To provide adequate support to those organizations that are either accredited/certified or seeking accreditation/certification, we will only answer those questions submitted by those organizations seeking accreditation/certification or currently accredited/certified by the Joint Commission. The Joint Commission no longer answers questions submitted by students or vendors. Thank you for your understanding.