Form CMS-116. Source: CMS form
Certificate application rules. Source: 42 CFR 493.43
Reporting changes, e.g. director. Source: 42 CFR 493.51
Form CMS-116 is the CLIA application for certification. It is used to apply for a new CLIA certificate and to report changes such as a new certificate type, new lab director, address or ownership change. This guide walks through the form section by section and explains what happens after you submit.
Not sure where your lab stands? Sound Lab Consultants helps labs with lab director and technical consultant services, inspection readiness and deficiency response.
Book a free 20-minute consultation · Get a free CLIA readiness check
Gather:
The lab's legal name, physical address and any federal tax ID (EIN)
The certificate type you need (see CLIA certificate types)
The lab director's name and qualifications. For nonwaived testing, the director must meet Subpart M qualifications for the complexity level (§493.1405 moderate, §493.1443 high), as updated by the personnel rule effective December 28, 2024. See CLIA personnel rule changes.
Your test menu, with the specialty or subspecialty and the estimated annual test volume for nonwaived tests
Your accrediting organization, if you are applying for a Certificate of Accreditation
Hours of operation, and whether the lab is mobile or covers multiple sites
1. General information: the facility name, address, CLIA number if you have one (blank for new labs) and contact person. The lab address must be a physical location.
2. Type of certificate requested: Waiver, PPM, Compliance or Accreditation. Labs requesting Compliance or Accreditation receive a Certificate of Registration first.
3. Type of laboratory: the facility type code, such as physician office, hospital or independent lab.
4. Hours of laboratory testing
5. Multiple sites: CLIA permits a single certificate for multiple sites only under limited exceptions (for example, not-for-profit or government labs doing limited public health testing, mobile units, or hospital labs at one campus) under §493.35(b), §493.43(b) and §493.55(b). Most separate locations need their own certificate.
6. Waived testing: list the waived tests and estimated volume.
7. PPM testing: list PPM procedures and volume if applicable.
8. Nonwaived testing: check the specialties and subspecialties and give annual test volume. Volume drives your fee schedule category.
9. Type of control: voluntary nonprofit, for-profit or government.
10. Director affiliation with other labs: list other labs the director directs. CLIA limits a director to no more than five nonwaived laboratories (§493.1407(d), §493.1445(d)).
11. Signature: the owner or the director signs. Unsigned forms are returned.
Read the official CMS-116 instructions before submitting. The form is revised periodically, so download the current version from cms.gov.
Submit the completed form to the State Agency (state survey agency) for the state where the lab is located. CMS lists state agency contacts on its CLIA website. Many states accept email or online submission; check with yours. Some states also require a separate state lab license; see our state license guide.
After the State Agency processes the form, CMS mails a fee coupon. Fees can be paid online through Pay.gov using the CLIA number on the coupon. For Compliance labs, CMS bills the registration fee and later the compliance (survey) fee; fees depend on certificate type and annual test volume (§493.638 through §493.649). See CLIA fee changes.
Certificate of Waiver or PPM: the certificate is issued after the fee is paid.
Certificate of Compliance: you receive a Certificate of Registration, which lets you start nonwaived testing. The State Agency then surveys the lab, and a Certificate of Compliance is issued once you are found compliant.
Certificate of Accreditation: you receive a Certificate of Registration, and the accreditor's survey follows.
Director qualifications not documented or not meeting the post-2024 requirements
Wrong certificate type for the test menu
Missing signature or test volumes
Multiple sites listed without a valid exception
Starting nonwaived testing before the Registration certificate arrives
Use CMS-116 (or the method your State Agency specifies) to report changes. Under §493.51 and §493.53, labs must notify the State Agency of changes in ownership, name, location or director within 30 days, and of changes in the testing performed (for example, adding a specialty) as specified in the regulations.
Who signs the CMS-116?
Can we test while the application is pending?
The owner or the laboratory director must sign the form. Unsigned applications are returned.
No. A new lab can begin testing only after it holds the appropriate certificate. For nonwaived testing, that's the Certificate of Registration.
How do we pay the CLIA fee?
Do we need a new CMS-116 to add moderate complexity tests to a waived lab?
CMS mails a fee coupon after the State Agency processes the application. Payment can be made online through Pay.gov using your CLIA number.
Yes. You must apply to change the certificate type and receive the new certificate before performing nonwaived tests.
How many labs can one director oversee?
A person may direct no more than five nonwaived laboratories (§493.1407(d), §493.1445(d)). Waived labs aren't limited the same way.
Sound Lab Consultants provides lab director and technical consultant services, inspection readiness and mock surveys, deficiency and sanctions response, new lab startup, and waived-to-moderate/high complexity upgrades.
Book a free 20-minute consultation, or start with a free CLIA readiness check.