CMS and CDC have proposed changes to CLIA requirements for laboratory director qualifications, personnel standards, oversight, and digital laboratory practice.
Your professional experience can help federal policymakers understand how these changes could affect laboratory operations, testing quality, and patient care.
Proposed rule: CMS-3478-P
Comment deadline: December 7, 2026
Learn more and submit your comment.
What makes an effective comment?
A strong comment does more than express support or opposition. It identifies a specific proposal, examines the agency’s reasoning, and then offers relevant evidence or professional experience. It makes a case for what the agency should do.
Your comments do not to speak to every provision. A focused, well-supported comment on one issue you know well can be more useful than a lengthy statement of general concerns.
Six tips to a stronger comment
1. Identify the proposed change
Choose a provision that relates to your expertise. Explain what CMS proposes and whether you support it, oppose it, or recommend modifying it.
When possible, identify the relevant regulatory section. For example, 42 CFR § 493.1443 addresses high-complexity laboratory director qualifications.
2. Address the agency’s reasoning
Your comment should engage with the reasons why CMS believes the change is appropriate. The agency cites objectives such as reducing regulatory burdens, addressing workforce shortages, recognizing relevant qualifications, and maintaining testing quality through existing safeguards.
Consider whether its reasoning matches your experience. What evidence supports the proposal? Are there assumptions, evidence gaps, or practical consequences CMS may not have fully considered?
For help understanding the proposed changes and CMS's reasoning, see the companion resource, "CMS Proposes Changes to CLIA Personnel Standards and Digital Laboratory Practice."
3. Support your position with evidence
Briefly establish your relevant professional background, then explain what you know.
Useful evidence could include:
A firsthand example involving laboratory quality, validation, oversight, or patient results.
Experience supervising, training, or assessing laboratory personnel.
Quality-assurance findings, inspection experience, or laboratory performance data.
Relevant scientific literature, professional standards, or other documented evidence.
Explain what your evidence demonstrates and why it matters. If you describe an example from your lab, be clear about what it shows that could apply to other labs.
4. Explain the consequences and possible alternatives
Describe how the proposed change could affect laboratory operations, professional accountability, testing quality, patient care, or access to testing.
Consider both potential benefits and risks. If you disagree with CMS's approach, explain whether a different requirement or safeguard could achieve the agency's objectives while addressing your concern, if applicable.
5. Make a specific recommendation
Conclude by explaining what you recommend that CMS do. You might recommend retaining an existing requirement, revising a proposed qualification pathway, adding a safeguard, or reconsidering a change until additional evidence is available.
Explain why your recommendation follows logically from the evidence you have presented.
6. Move beyond a general objection
General statement
"Twenty continuing education credit hours are not enough to prepare a laboratory director."
A better approach:
Describe a situation in which a laboratory director needed to evaluate whether the available validation evidence adequately supported a test's intended clinical use.
Explain what made the decision challenging, which competencies were necessary, and how those competencies were developed or demonstrated.
Then connect that experience to CMS’s proposal to permit certain laboratory directors to qualify through alternative pathways, including 20 continuing education credit hours covering laboratory-director responsibilities. Explain whether that pathway adequately demonstrates the necessary competencies and recommend a specific change if warranted.
Laying out your evidence and reasoning clearly is what makes your comment valuable.
Your knowledge, judgment, and experience are what make your comment valuable.