How to Update a CLIA Certificate: Director, Ownership, Name, Address and Testing Changes
To change the lab director on a CLIA certificate, or report a change of ownership, name or location, notify your State Agency within 30 days, usually on Form CMS-116 marked as a change. Accredited labs also notify their accreditor. New tests outside your certificate, or new specialties, follow separate rules and deadlines under 42 CFR Part 493.
Last reviewed Oct 2026 · By Sound Lab Consultants CLIA team · Based on the current text of 42 CFR Part 493 and Form CMS-116 (03/24). Not legal advice.
Key facts and official sources
Certificate of Compliance and registration certificate labs: 30 days for ownership, name, location, director or (high complexity only) technical supervisor: 42 CFR 493.51(a), §493.45(b)(2).
Waiver and PPM labs: 30 days for ownership, name, location or director: §493.39(b), §493.53(b).
Accredited labs: notify HHS and the accreditation program within 30 days: §493.63(a).
New tests: within 6 months for Compliance and Accreditation labs; before testing for Waiver and PPM labs.
Each individual may direct no more than five laboratories: §493.1407(d) and §493.1445(d).
State Agencies handle CMS-116 applications, demographic updates and director changes: CMS CLIA program.
Which CLIA changes do you have to report, and how fast?
Every certificate type has a 30-day window for changes in ownership, name, location and director. The differences are in the technical supervisor and testing changes:
Waiver (§493.39): Ownership, name, location, director: Within 30 days; Technical supervisor: Not listed; New tests or specialties: Before performing non-waived tests
PPM (§493.53): Ownership, name, location, director: Within 30 days; Technical supervisor: Not listed; New tests or specialties: Before performing tests beyond PPM and waived
Compliance (§493.51): Ownership, name, location, director: Within 30 days; Technical supervisor: Within 30 days (high complexity only); New tests or specialties: Within 6 months after; methodology changes within 6 months
Accreditation (§493.63): Ownership, name, location, director: Within 30 days, to HHS and the accreditor; Technical supervisor: Not listed in §493.63; New tests or specialties: Notify the accreditor within 6 months
CMS directs labs to their State Agency for CMS-116 applications, demographic updates and director changes, and tells accredited labs to contact their accreditation organization. Accreditors may have their own notice rules, so check with yours.
How do you change the lab director on a CLIA certificate?
Check "Change in Laboratory Director" in Section I of Form CMS-116 and give the effective date. For PPM, Compliance and Accreditation certificates, include the director's qualifications. The instructions list:
verification of state licensure, as applicable;
documentation that CLIA personnel qualifications are met (for example, diploma and transcript);
credentials; and
laboratory experience.
Foreign-educated directors need an equivalency evaluation of their education. Missing documentation delays processing.
The new director must meet the Subpart M qualifications for your complexity level. See CLIA lab director requirements and CLIA personnel qualifications. Section X of the CMS-116 lists the director's other labs, and one person may direct no more than five (§493.1407(d), §493.1445(d)). The director of a moderate or high complexity lab must also make documented on-site visits at least every 6 months, with at least 4 months between the two minimum visits (§493.1407(c), §493.1445(c)).
What about a new technical supervisor?
High complexity labs must have a qualified technical supervisor (§493.1447). Compliance and registration certificate labs doing high complexity testing report a new technical supervisor within 30 days (§493.51(a)(5), §493.45(b)(2)). Ask your State Agency, or your accreditor, how to submit it.
How do you report a CLIA change of ownership (CHOW)?
Every certificate type requires notice within 30 days of a change in ownership. On the CMS-116, check "Other Changes (Specify)" and give the effective date. Section IX asks for the type of control, and the form asks whether a non-U.S. government or entity has any ownership or control. The instructions define an owner as anyone with any interest in the lab, except an interest in a lab whose stock is publicly traded.
Part 493 does not spell out what supporting documents a CHOW needs or whether the CLIA number stays the same. Ask your State Agency before closing, and check any state laboratory license. A CHOW often comes with a director change, so plan both together. For health-system deals, see health system laboratory integration.
How do you update a CLIA certificate for a name or address change?
Both are 30-day changes. Use "Other Changes (Specify)" on the CMS-116 with the effective date.
Name. The facility name you enter is what appears on your certificate, so be specific if the lab is part of a larger entity.
Address. The physical facility address must be where testing is performed. It may include a floor, suite or room but cannot be a P.O. box or mail stop. Mailing and corporate addresses are optional and may use a P.O. box.
Adding a site, rather than moving one, may need its own certificate. See CLIA compliance for multiple locations. Whether a move triggers an inspection varies, so contact your State Agency or accreditor.
How do you add tests, specialties or a higher complexity?
Waiver or PPM to moderate or high complexity. A registration certificate is required for waiver or PPM labs that intend to perform moderate or high complexity tests (§493.45(a)(2)). Waiver and PPM labs must notify HHS before performing tests their certificate does not cover (§493.39(a), §493.53(a)). The CMS-116 has a "Change in Certificate Type" box. See upgrade from CLIA waiver to moderate or high complexity.
New specialty or subspecialty. Certificate of Compliance labs notify HHS no later than 6 months after performing tests in a specialty not on the certificate. Accredited labs notify their accreditor within the same 6 months (§493.51(b), §493.63(b)).
Methodology changes or deletions. The same 6-month window applies (§493.51(c), §493.63(c)).
Certificate fees cover changes in certificate type, with amounts set by the latest Federal Register notice (§493.638). CMS says fees are paid online through pay.gov. See CLIA certificate types and test complexity.
CLIA certificate change checklist
Identify the change, your certificate type and the deadline.
Download the current Form CMS-116 from CMS and check the right Section I box: Change in Laboratory Director, Change in Certificate Type, or Other Changes (Specify).
Enter your 10-digit CLIA number and the effective date of the change.
For a director change on a PPM, Compliance or Accreditation certificate, attach the director's qualification documents and complete Section X.
Send the form to your State Agency. Do not send money with it.
If accredited, notify your accreditation program.
Update state licenses, procedures and personnel records, and keep copies of what you sent.
Our CMS-116 application guide walks through each section of the form.
Frequently asked questions
How long do I have to report a new lab director to CLIA?
30 days. Every certificate type requires notice within 30 days of a change in director (§493.39, §493.51, §493.53, §493.63). Report it to your State Agency, and to your accreditor if you are accredited.
Do I use Form CMS-116 to report a CLIA change?
Usually. Form CMS-116 has boxes for Change in Certificate Type, Change in Laboratory Director and Other Changes (Specify), each with an effective date. Confirm with your State Agency in case it wants anything else.
Does a CLIA certificate transfer with a change of ownership?
Part 493 requires notice within 30 days of a change in ownership but does not spell out how the certificate is handled. Ask your State Agency what it needs and whether your CLIA number stays the same.
Can my new lab director direct other labs too?
Yes, up to five laboratories per person under §493.1407(d) and §493.1445(d). List the director's other labs in Section X of the CMS-116.
Do I need to report adding a new test?
Waiver and PPM labs must notify HHS before performing tests their certificate doesn't cover. Compliance and accredited labs have 6 months to report a new specialty or a methodology change.
Get your CLIA change filed right the first time
Start with our free CLIA readiness check, then talk with us about your change. Sound Lab Consultants works with labs nationwide.