14. Department of Health and Human Services · Notable
Revise CLIA scope-of-practice rules for clinical laboratories
Printed page 470 14. Department of Health and Human Services
“Expand the scope of practice of low-complexity and moderate-complexity clinical laboratories. … CMS should similarly revise CLIA rules regarding scope of practice for clinical laboratories and testing personnel.”
What has happened
- Attempted
CMS and CDC proposed the first amendments to the CLIA personnel rules since the 2023 final rule, and they widen who may test and direct. The proposal would recognize nonhuman (animal and research) laboratory experience and training toward personnel qualifications, adopt a broader degree framework keyed to Education Department classification codes, let respiratory-therapy and pulmonary-function graduates qualify for blood gas testing on either degree route rather than both, extend the moderate-complexity director grandfather clause to those who directed high-complexity testing, add an associate-degree route for blood gas technical consultants, and codify associate-degree routes for high-complexity testing personnel, citing workforce shortages. It also allows virtual access under the primary laboratory's certificate. A proposal, so still `attempted`; the Quote's first sentence, the scope of low- and moderate-complexity laboratories themselves, is not what this changes.
- Attempted
CMS and CDC issued a request for information on the CLIA regulations - unchanged in substance since 1992 - covering breath testing, laboratory processes and procedures, emergency preparedness, biosafety, biosecurity, cybersecurity and specialty testing areas, and asking specifically about the education and experience of personnel who perform specimen preparation and about technology-assisted assessment of testing personnel competency. Responses "may be used to help inform CMS and the CDC as to what types of action, if any, should be taken to update the existing CLIA regulations through future notice and comment rulemaking." A step toward revising the personnel and scope rules, with nothing changed yet.
Research log
What was searched, and what didn’t count as evidence
Research notes
- The RFI was read in full at https://www.govinfo.gov/content/pkg/FR-2026-07-16/html/2026-14358.htm. The phrase “scope of practice” does not appear in it; the personnel questions (17 occurrences of “personnel”) are the part that bears on this ask.
- Queries: Federal Register “CLIA” since 2025-01-20 → 32 documents and “Clinical Laboratory Improvement Amendments” → 21; apart from this RFI they are accreditation-organization approvals (COLA, the Joint Commission) and information-collection notices. The CLIA personnel requirements at 42 CFR part 493 subpart M are unamended.
- The NPRM after the RFI (found 2026-10-12, resolved in review). A review of new records found CLIA; Virtual Access, Gynecologic Cytology PT, Personnel Qualifications, and Other Changes (91 FR 64480, FR 2026-20613, comments due 2026-12-07) but could not tell from the abstract which way the personnel changes go. The review read the personnel sections: they widen (nonhuman laboratory experience, the degree framework, blood gas “and” to “or”, the director grandfather clause, associate-degree routes), so it gets a same-rung attempted event. “Scope of practice” appears once, in the commenters’ words about IVF laboratories.
- Action
- expand
- Object
- CLIA scope-of-practice rules
- ID
- 1295