On December 28, 2024, a number of new and revised CLIA regulations go into effect, including new definitions and updates to numerous personnel requirements. These revised regulations (CMS-3326-F) were published in the Federal Register on December 28, 2023. and can be accessed at https://www.federalregister.gov/d/2023-28170.
A summary of some of these updates for December are below.
One revised (revised language is underlined) and four new definitions will go into effect. These are as follows:
· Continuing education (CE) credit hours means either continuing medical education (CME) or continuing education units (CEUs). The CE credit hours must cover the applicable laboratory director responsibilities and be obtained prior to qualifying as a laboratory director.
· Doctoral degree means an earned post-baccalaureate degree with at least three years of graduate level study that includes research related to clinical laboratory testing or advanced study in clinical laboratory science, medical laboratory science, or medical technology. For purposes of this part, doctoral degrees do not include doctors of medicine (MD), doctors of osteopathy (DO), doctors of podiatric medicine (DPM), doctors of veterinary medicine (DVM) degrees, or honorary degrees.
· Experience directing or supervising means that the director or supervisory experience must be obtained in a facility that meets the definition of a laboratory under this section and is not excepted under §493.3(b).
· Laboratory training or experience means that the training or experience must be obtained in a facility that meets the definition of a laboratory under § 493.2 and is not excepted from CLIA under § 493.3(b).
· Midlevel practitioner means a nurse midwife, nurse practitioner, nurse anesthetist, clinical nurse specialist, or physician assistant licensed by the State within which the individual practices, if such licensing is required in the State in which the laboratory is located.
Laboratory director qualifications and responsibilities have also been revised. Some of these changes are as follows:
- 20 earned CEs that cover laboratory director responsibilities for all laboratory directors except doctors of medicine and doctors of osteopathy who are certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology.
- Where the requirements state a degree in “laboratory science,” acceptable degrees are biological, chemical, or laboratory science degrees. A degree in physical science is no longer considered acceptable in the regulations. Individuals without a biological, chemical, or laboratory science degree can meet the personnel requirements through an educational algorithm (explained on pages 90005–90006 of the final rule).
- Remove the residency provision; however, relevant experience in a residency or fellowship would continue to be acceptable experience and training for qualifying individuals.
- The laboratory director must 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.
- There is a grandfather clause for all personnel affected by this final rule as long as they were qualified and serving in a CLIA-ceritfied lab as of December 28, 2024 and remained continuously employed in that position since December 28, 2024.
Again, the complete final rule can be accessed at https://www.federalregister.gov/d/2023-28170.
I welcome your comments and questions — please send them to me at [email protected].
