The 2026 CLIA proposed rule: what would change for your laboratory

Laboratory director qualifications

• Doctoral scientists directing high complexity testing would no longer need board certification. One year directing or supervising high complexity testing, or 20 continuing education hours on director responsibilities, would qualify.
• Similar either-or routes would apply to doctoral, master's and bachelor's candidates directing moderate complexity testing.
• Physicians could qualify through one year of laboratory training during residency or fellowship.
• Certain animal and veterinary science degrees would count toward qualification.

Director site visits

• The requirement for at least two on-site visits a year, at least four months apart, would be removed for moderate and high complexity laboratories. The director would stay responsible and reachable.

Competency assessment for provider-performed microscopy

• The director's duty to evaluate and document PPM competency, twice in the first year and annually after, would be rescinded. Competency assessment for moderate and high complexity testing personnel is not part of this change.

Proficiency testing

• The mandatory six-month wait before reinstatement after certain proficiency testing failures would be removed, provided the reinstatement requirements are met.

Remote review of digital data

• Qualified personnel could review digital data, results and images remotely under the testing laboratory's own certificate, with conditions on security, confidentiality and documentation. Cytology stays excluded, and PPM certificates are excluded.

Test reports

• Reports would have to show the laboratory's CLIA number and the name on its certificate.

Other items

• Digital image retention, email-change notifications, same-campus certification, gross tissue examination, blood-gas personnel, and removal of obsolete COVID-19 reporting rules.

What to do now

• Keep following the current rules. A surveyor assesses against the regulation in force on the day of the survey.
• If the proposal affects you, comment before December 7, 2026 at regulations.gov under docket CMS-2026-3235.
• Do not drop PPM competency assessments or director site visits on the strength of a proposal. CMS has used enforcement discretion on some 2023 requirements since June 2025, so check with your State agency if you are unsure what is being enforced.
• If you are accredited, your accreditation organization's requirements apply whatever the federal rule says.

What it means for our kits

The kits follow the rules in force. If the rule is finalized as proposed, we would revise the PPM form and policy section in the Competency Assessment Kit, the reinstatement notes in the Proficiency Testing Kit, and the report checklist in the Inspection Readiness Kit. Each change would be listed in the verification log.

Sources

This page is based on the summaries published by AABB and ADLM. Read the proposed rule itself in the Federal Register (document 2026-20613) before relying on any detail here. This page is general information, not regulatory or legal advice.