Labs with a Certificate of Compliance, Accreditation, Registration or PPM. Certificate of Waiver labs have no CLIA personnel qualification requirements beyond following manufacturer instructions.
Individuals who were qualified and serving in their role in a CLIA-certified lab as of December 28, 2024, and have served continuously since, remain qualified (for example, §493.1411(b)(7)) for that role at that lab type under the prior requirements. The protection is tied to continuous service in the position. A person who leaves the role, or moves into a new one, generally must meet the current qualifications. Keep employment records that prove continuous service.
Degree definitions. The rule defines qualifying degrees and coursework more specifically. A degree in a "physical science" is no longer accepted on its own; qualification is based on degrees in chemical, biological, clinical or medical laboratory science or medical technology, or a specified number of semester hours in those subjects.
Nursing degrees. Nursing degrees are now explicitly listed for moderate complexity testing personnel: a doctoral, master's or bachelor's degree in nursing (§493.1423(b)(2)) or an associate degree in nursing (§493.1423(b)(4)). Nursing is not listed in §493.1489 for high complexity testing; CMS stated nurses qualify only where a nursing degree is specifically listed (88 FR 89976, Dec. 28, 2023).
Moderate complexity lab director (§493.1405). Physicians (MD, DO or DPM) without pathology board certification now need at least 1 year directing or supervising nonwaived testing and at least 20 CE credit hours covering the director responsibilities in §493.1407 (§493.1405(b)(2)). Doctoral, master's and bachelor's paths each now require 20 CE hours plus defined experience. Doctoral-scientist directors have updated degree and certification paths.
High complexity lab director (§493.1443). Pathways were updated, including the doctoral degree definitions and acceptable board certifications.
Technical consultant (§493.1411). A new path allows an individual with an associate degree in medical laboratory technology, medical laboratory science or clinical laboratory science, plus at least 4 years of nonwaived training or experience in the specialties they oversee, to serve as technical consultant (§493.1411(b)(5)). Respiratory therapy and cardiovascular technology bachelor's degrees qualify for blood gas analysis (§493.1411(b)(6)).
Director onsite presence (§493.1407(c), §493.1445(c)). Lab directors must be onsite at least once every six months, with at least four months between the minimum two visits, and must document the visits, including evidence of performing director responsibilities. Directors must stay accessible for remote consultation between visits.
Blood gas testing personnel have specific qualification provisions.
Always check the current eCFR text for the exact pathway before naming someone to a role. Subpart M is detailed, and small differences in coursework or experience matter.
Inventory every named role on your CMS-116 and personnel records.
Document grandfathered staff with dates of hire and continuous service.
Check new hires and promotions against current qualifications before they start.
Schedule and log director onsite visits.
Update job descriptions and delegation letters for technical consultant, technical supervisor and general supervisor duties.
Report a change of director to your State Agency within 30 days (§493.51).
Naming a new director under pre-2024 qualifications
Assuming grandfathering transfers to a new lab or role
No documentation of the director's onsite visits
Testing personnel qualified by a physical science degree hired after December 28, 2024
We provide qualified CLIA lab directors and technical consultants, review personnel files against Subpart M, and keep documentation ready for survey. See CLIA lab director and technical consultant.
When did the new CLIA personnel requirements take effect?
Are current employees grandfathered?
December 28, 2024, under final rule CMS-3326-F published December 28, 2023.
Individuals qualified and continuously employed in their role since December 28, 2024 remain qualified for that role. New roles and new hires must meet current requirements.
How often must the lab director be onsite?
Can a nurse perform moderate or high complexity testing?
At least once every six months, with at least four months between visits, documented by the lab (§493.1407(c), §493.1445(c)).
Moderate complexity, yes: nursing degrees are listed in §493.1423(b)(2) and (b)(4). High complexity: §493.1489 does not list nursing degrees, so a nurse must qualify another way (for example, the coursework equivalency in §493.1489(b)(3)(ii)) or be grandfathered (§493.1489(b)(5)).
Does this affect waived labs?
No. Certificate of Waiver labs don't have CLIA personnel qualification requirements.
Sound Lab Consultants provides lab director and technical consultant services, inspection readiness and mock surveys, deficiency and sanctions response, new lab startup, and waived-to-moderate/high complexity upgrades. Book a free 20-minute consultation, or start with a free CLIA readiness check.