Do all states accept the CMS-116 alone?

No. Texas will not process it without Form 3225, Hawaii wants Form 1513 and its own permit application for most sites, and New York's POLEP wants a DOH-5793 and an IRS tax ID letter. Washington does not take a CMS-116 at all.

Who signs the CMS-116?

Federally, an owner or authorized representative of the lab. Iowa, Kansas and North Carolina require the lab director's signature, and Pennsylvania wants both the director and owner. A consultant never signs it.

Does DC need director documents for a Certificate of Waiver?

Yes. DC Health asks for the CMS-116 with a copy of the director's DC medical license, PhD or highest degree earned, including for later changes.

Can Michigan labs list several email addresses on the CMS-116?

No. Michigan says only one email address may be entered into the CMS database, so use one the lab monitors regularly.

State Forms Filed With the CMS-116

Every CLIA application in the country starts with the same federal form, the CMS-116. What happens next depends on the State Agency that receives it. Some states process the federal form alone. Others hold it until a state form arrives, want specific attachments, or require a particular person's signature. None of these extras is optional in the state that asks for it. Texas, for one, says it will not process an application until its regional office has the state form, and the CMS-116 instructions warn that incomplete applications cannot be processed and are returned to the facility.

The list below covers states whose requirements we have read on their own pages or rules. It is not every state. Your state's requirements page has the current entry.

Which states require a separate state form?

Texas: Form 3225

Texas Health and Human Services uses Form 3225, Application for Certification, Supplement to CMS 116, to process every CLIA application, and lists it as "Form 3225, Disclosure of Ownership" for each certificate type. "HHSC will not process Form 3225 applications until the CLIA State Agency regional office receives and approves all requested information." The packet goes to one of five regional offices. Details in Texas Form 3225 and CLIA in Texas.

Hawaii: Form 1513, OHCA 110.1 and sometimes CMS-209

Hawaii's Office of Health Care Assurance asks every lab for a "Disclosure of Ownership and Control Interest Statement (Form 1513)" with the CMS-116. Labs that are not single-physician offices also file the state's "Application for Clinical Lab Permit/License (OHCA 110.1)," because they need a Hawaii permit too, and PPM labs add the "Laboratory Personnel Report form (CMS 209)." See Hawaii's Class I laboratory permit.

New York physician offices: DOH-5793, an IRS letter and the management contract

New York's Physician Office Laboratory Evaluation Program accepts the CMS-116 but lists more: a "Disclosure of Ownership Form DOH-5793," an "IRS-issued letter showing the facility's name and federal tax identification number" (the SS-4 letter), "A copy of the director's current license to practice in New York State, if applicable," and either the lab's management contract or a statement that there is none. The facility name on the CMS-116 "must match the name of your business entity registered with the IRS." See physician office labs in New York.

Tennessee: the Waived Testing Notification

Tennessee's Medical Laboratory Board rule 1200-06-03-.17 requires waived testing sites it covers to notify the Board "using Board approved forms," which is form PH-3653. It asks for the site's CLIA number, so it follows the federal certificate. See Tennessee's medical laboratory rules for waived testing.

Where is the state filing a separate application altogether?

In several states, the extra paperwork is a full state application filed alongside the CMS-116:

Pennsylvania treats the CMS-116 and its clinical laboratory permit application as one packet. The Bureau of Laboratories' checklist tells applicants to verify the address, director and tax ID match on both and that "both applications are signed by the Director and Owner." See Pennsylvania's clinical laboratory permit.
California requires a CDPH registration for every waiver and PPM lab, listing tests, kits, methods, equipment and personnel (Bus. & Prof. Code § 1265). See California's registration for waived tests.
Maryland requires an OHCQ application for a letter of exception or permit, signed by the lab director (COMAR 10.10.03.04). See Maryland's letter of exception.
Maine requires a state license application with a copy of the CLIA certificate and a State Fire Marshal inspection report for non-exempt labs. See Maine's limited license.

Do any states want director documents for a waiver?

District of Columbia. DC Health asks applicants to send the CMS-116 "with a copy of the director's DC medical license, PhD, or highest degree earned," and to include the director's license or degree with later changes too.
Pennsylvania. The permit checklist asks every lab for proof of the director's doctoral degree, and for a physician-directed waiver lab, a copy of the medical license.
Illinois needs only the CMS-116 for a waiver, but "HOME HEALTH CARE facilities must include a copy of their Illinois Home Health Care License."

For PPM and higher certificates, many states want director proof. Michigan asks for "A copy of the State of Michigan license" and warns: "Do not submit screenshots or printed versions of the LARA Find/Verify a License webpage. It must be a copy of the license." Idaho publishes a Director Qualification Form "Required for Certificate of Compliance or Certificate of Accreditation initial applications or director changes." Texas asks PPM applicants for "a copy of the facility director's current Texas medical license" or nursing license.

Who has to sign?

Federal rules let "an owner, or... an authorized representative of the laboratory" sign (42 CFR 493.35(c)(2)), and the CMS-116 signature line reads "SIGNATURE OF OWNER/DIRECTOR OF LABORATORY." Some State Agencies are stricter:

Iowa: "The Iowa State Agency requires the individual listed as the laboratory director to sign page 5 of the application."
Kansas: "All CLIA changes will need to be completed on the Federal CLIA Application Form CMS 116 (PDF) and signed by the laboratory director."
North Carolina: "The 116 form must be signed by the laboratory director."
Pennsylvania: both the director and the owner sign both forms.

In every state, the signature belongs to someone at the lab. A consultant or preparer cannot sign it, because the signature carries the lab's attestation that it will operate under CLIA and its consent to inspection.

Where is there no CMS-116 at all?

Washington and, for most sites, New York. CMS's State Agency list says of Washington: "Please do not submit a Form CMS-116 for WA MTS Licensure." Washington sites apply for a Medical Test Site license instead. In New York, sites outside the physician office program file a Limited Service Laboratory registration (form DOH-4081) or a permit application with the Clinical Laboratory Evaluation Program, and the registration certificate carries the CLIA number. See Washington's Medical Test Site license and New York's Limited Service Laboratory registration.

Which small details cause the most returns?

Names that do not match. New York and Pennsylvania both check the facility name and tax ID against other documents.
Missing pages. Michigan notes the instruction pages (6 to 10) need not be sent, but every section of the form itself must be complete. Michigan also says only one email address can be entered in the CMS database, so pick one the lab monitors.
Old form versions. The current CMS-116 is the 03/24 edition, with the signature on page 5. Some State Agency pages still describe older versions.
Fees sent to the state. CMS bills the federal fee by emailed coupon. Texas, Florida and North Carolina all say not to send CLIA fees to the state.

How do we handle state forms?

Every application we prepare includes the state's supplement, attachments and signature requirements for that site's state, checked against the State Agency's current page. The owner or director signs; we can send the signed packet to the State Agency. A single site is $399 under our Certificate of Waiver Application, and state registrations, permits and licenses are $299 or $699 per state depending on the filing.