How long do I have to report a new CLIA director?

30 days from the change, for every certificate type, in writing. State Agencies may not accept oral notice.

Do I need a new CMS-116 to change the director of a waiver lab?

Not necessarily. CMS accepts written notice by email, fax or letter with the lab's name, CLIA number, the change and the director's or designee's signature. A new CMS-116 also works.

Can one person direct six PPM labs?

No. For PPM, compliance and accreditation certificates, an individual may direct no more than five certificates.

Changing Your CLIA Laboratory Director

Q: What does a revised CLIA certificate cost?

As of October 2026, $95 for a waiver or PPM lab and $150 for registration, compliance and accreditation labs. The fee is paid before the revised certificate issues.

Directors leave. A medical director retires, a nurse practitioner who directed a PPM lab moves to another practice, a pharmacy changes its pharmacist-in-charge. The CLIA certificate still carries the old name, and every certificate type has the same deadline for fixing that: 30 days.

How fast do you have to report a new director?

Within 30 days of the change, for every certificate type. The rules say so separately for each one: waiver labs at 42 CFR 493.39(b)(4), PPM labs at 493.53(b)(4), compliance labs at 493.51(a)(4), and registration and accreditation applicants at 493.57(a)(2). CMS's Quick Start Guide (March 2026) shows the same 30 days across all five certificate types, and adds a technical supervisor change on the same clock for registration and compliance labs doing high complexity testing.

Notice has to be in writing. CMS tells State Agencies that they "must not accept oral notices of change or intent to change" (State Operations Manual, Chapter 6, section 6016).

Does the paperwork differ by certificate type?

That depends on the certificate.

Certificate of Waiver

Federal rules set no qualifications for a waiver lab's director, so the State Agency needs only the change itself. CMS accepts written notice, which "includes an email, fax, or hard copy letter" and "must include the laboratory's name, CLIA number, the name of the Laboratory Director and/or Owner, the change(s) being made, and the signature of the Laboratory Director or designee." A new CMS-116 is also acceptable (SOM section 6016.1). On the form, mark the change and give its effective date.

PPM certificate

CMS requires a new CMS-116 for a "Laboratory Director Change (Provider-Performed Microscopy (PPM) Certificate or Certificate of Compliance)" (SOM section 6016.1). The new director must qualify under 42 CFR 493.1357: a physician, a midlevel practitioner "authorized by a State to practice independently in the State in which the laboratory is located," or another practitioner the rule names, holding any state lab director license the state requires. Proof goes with the form: "Verification of State Licensure, as applicable," education documents, credentials and laboratory experience (CMS-116 instructions). See the PPM certificate.

Certificate of Compliance and registration

Also a new CMS-116, with documentation that the new director meets subpart M for the complexity tested. The State Agency "is responsible for verifying that the Director meets the appropriate personnel qualifications" and may ask for licensure, diplomas, transcripts, "evidence of Continuing Education (CE) credits in laboratory practice" and experience (SOM section 6006.7). See director requirements by certificate type and the 2024 rule on director CE and on-site visits.

Certificate of Accreditation

Once a lab holds a Certificate of Accreditation, "the AO will be responsible for the qualification and entry of laboratory director changes" into the CLIA data system. While the lab still holds its Certificate of Registration, the State Agency qualifies the director. A CMS-116 sent to the State Agency by an accredited lab is kept as documentation, and changes "to specialties and laboratory director should be handled by the laboratory's AO" (SOM section 6016.1.1).

Which rules can trip up the new director?

The five-lab cap. "For a Certificate for PPM, Certificate of Compliance or Certificate of Accreditation, an individual can only serve as the director for no more than five certificates" (CMS-116 instructions). A director who already directs five PPM, compliance or accreditation labs cannot take a sixth. Waiver labs are listed in Section X but not capped by that sentence. See the five-lab limit.
Section X. The new director's other labs, by CLIA number and name, go in Section X of the CMS-116.
A state license. Where a state licenses lab directors, the PPM rule requires that license "if the licensing is required" (493.1357(a)).
A gap. If no qualified director is in place for a PPM or nonwaived lab, testing that needs that director should stop until one is.

What does the revised certificate cost?

A revised certificate is one "reissued with changes to one or more fields displayed on the certificate, such as the laboratory's name, address, laboratory director" (SOM section 6018). Under the fee rule in effect since January 27, 2024, it costs $95 for a waiver or PPM lab and $150 for registration, compliance and accreditation labs, as of October 2026 (Minnesota Department of Health CLIA page, applying CMS-3326-F). The fee "must be paid in full before the revised certificate will be issued" (42 CFR 493.639(a)). The coupon comes by email from CMS and is paid on pay.gov.

Do states have their own director-change rules?

Yes, and some are stricter than CLIA. California's is the sharpest: a state lab license or registration "shall be automatically revoked 30 days from a major change of laboratory directorship or ownership," unless the lab submits a completed new application within those 30 days. To keep testing in the meantime, the owner may appoint a qualified interim director "within five business days of the major change," with written notice to the department within five business days of the appointment. Failure to report any director change within 30 days also results in "automatic revocation" (Bus. & Prof. Code 1265(e), (g)). See California's registration.

New York's Limited Service Laboratory program has its own Change in Laboratory Director form. See New York's Limited Service Laboratory registration and each state on the state requirements index.

How do we handle a director change?

We prepare the written notice or new CMS-116, assemble the new director's qualification documents for a PPM or nonwaived lab, check the five-lab cap against Section X, and prepare any state change form. The owner or new director reviews and signs, and the lab pays the revised certificate fee to CMS directly. A CLIA Change Request is $149 per change. Renewal and Compliance Tracking ($299 per year for the first lab) includes reminders for the 30-day window. We never serve in the director role ourselves.