Changes to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations related to laboratory director qualifications are set to take effect soon.
A final rule published by the Centers for Medicare & Medicaid Services (CMS) on Dec. 28, 2023, implemented the updates “to address obsolete regulations and update the regulations to incorporate technological changes and changes in laboratory practices.”
The rule revised the language in the regulations regarding laboratory director qualifications. A laboratory director of high-complexity testing must hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution and be certified and continue to be certified by a board approved by the U.S. Department of Health and Human Services. Current CLIA requirements already include a pathway for doctors of medicine, doctors of osteopathy, and doctors of podiatric medicine degrees to become directors.
Additionally, laboratory directors will be required to be on-site at the laboratory at least once every six months, with at least a four-month interval between the two on-site visits. The laboratory must provide documentation of all visits, along with evidence that the director is completing their assigned responsibilities to ensure the laboratory is in continuous compliance with CLIA regulations. Documentation may include, but is not limited to, sign-in/sign-out logs, meeting minutes/summary, notes of observations, and travel vouchers. Finally, the laboratory director must still be accessible to the laboratory via telephone or electronic consultation, as needed.
These and other personnel requirement updates are set to take effect on Dec. 28, 2024. Questions about these changes may be directed to laboratories’ local state agencies, which maintain the certificate information for new and existing laboratory providers within their state. A list of CLIA state agency contacts can be viewed on the CMS website.
Sources:
https://www.cms.gov/files/document/qso-24-03-clia.pdf
https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments
https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/certficiation-boards
