CMS-116
CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 (CLIA) APPLICATION FOR CERTIFICATION
Form CMS-116 is the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification from the Centers for Medicare & Medicaid Services. Its instructions say CLIA requires every facility that tests human specimens for the diagnosis, prevention or treatment of any disease or impairment, or the assessment of health, to meet certain Federal requirements, and that such a facility is considered a laboratory under the law. They add that waived tests are not exempt from CLIA.
The form has ten sections: general information, type of certificate requested, type of laboratory, hours of testing, multiple sites, waived testing, PPM testing, non-waived testing, type of control, and the director's other laboratories. It ends with a consent statement signed by the owner or director. It carries OMB No. 0938-0581, with an expiration date of 03/31/2027, and estimates an average of one hour per response.
The form says completed applications go to the local State Agency, with no payment enclosed. You can fill it out free in your browser on this page and download the result without an account.
CLIA identification number (blank for an initial application), application type and effective date, facility name, federal tax ID, email, phone, fax, physical facility address (no P.O. boxes), optional mailing and corporate addresses, and the director's name, credentials and phone.
Check one: Certificate of Waiver, Certificate for Provider Performed Microscopy Procedures (PPM), Certificate of Compliance, or Certificate of Accreditation with the accrediting organization: The Joint Commission, ACHC, AABB, A2LA, CAP, COLA or ASHI.
One laboratory type from codes 01 to 29, testing hours for each day in HH:MM format or a 24/7 box, and whether one certificate covers multiple sites under one of three regulatory exceptions.
Waived tests by analyte, test name and manufacturer; the nine PPM procedures; non-waived tests marked M (moderate) or H (high complexity); and estimated annual test volume by specialty and subspecialty.
Type of control (voluntary nonprofit, for profit or government, codes 01 to 09), whether a non-United States-based government or entity has ownership or control, and other separately certified laboratories the director also directs.
A penalty notice under section 353 of the Public Health Service Act, consent to operate under HHS standards and permit inspection, printed names of the director and owner, and the owner or director's signature in ink or a secure electronic signature, with the date.
The form says all applicable sections are completed. Each certificate type in Section II names the sections it needs.
The instructions say to select the certificate based on the highest level of test complexity the laboratory performs. Each box in Section II lists the sections to complete, for example Sections I to VI and IX to X for a Certificate of Waiver.
Check the application type and enter the facility, address and director details. The instructions note that the facility name given is what appears on the certificate.
Choose the laboratory type, enter testing hours, answer the multiple sites question, and list tests in Sections VI to VIII with estimated annual volume. The form includes guidelines for counting tests.
For a PPM, Compliance or Accreditation certificate, the instructions list verification of State licensure, as applicable, plus documentation of qualifications, credentials and laboratory experience. They say leaving it out delays processing.
The owner or director signs and dates the consent. The form says completed applications go to the local State Agency and that no payment is sent with them.
You get the real form, filled in a browser tab, with nothing standing between you and the finished PDF.
To the local State Agency. The form points to the State Agency contact list at cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA.pdf. The CMS address in the PRA statement is for comments on the form only, and the form says not to send applications there.
The form says not to send any money with the application. After the State Agency processes it, a fee remittance coupon shows the CLIA number and the amount due for the certificate and, if applicable, the compliance (survey) or validation fee. The form lists no amounts.
For a Certificate of Compliance or Accreditation, the form says the laboratory first pays for and receives a Registration Certificate, which permits testing until an onsite inspection, or until CMS receives verification of accreditation.
For a Certificate of Accreditation, the form asks for evidence of accreditation by an approved organization, or of application for it, within 11 months after receipt of the Certificate of Registration.
The instructions say incomplete applications cannot be processed and will be returned to the facility, and ask for legible print or typed entries.
The form estimates an average of one hour per response. It carries OMB No. 0938-0581 with an expiration date of 03/31/2027.
The instructions describe which facilities count as laboratories under CLIA and which do not.
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The instructions say a facility that tests human specimens for diagnosis, prevention or treatment of disease, or assessment of health, is a laboratory under CLIA. Facilities that only collect or prepare specimens, only mail them, or only do forensic testing are not covered.
The form says completed applications go to the local State Agency. Contact details are at cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA.pdf.
No. The form says not to send any payment with the application. A fee remittance coupon with the amount due is issued after the State Agency processes it.
The instructions say to select it based on the highest level of test complexity performed. A Certificate of Waiver covers only waived tests, PPM covers PPM and waived tests, and Compliance or Accreditation covers waived, PPM and moderate or high complexity tests.
The instructions say waived tests are not exempt from CLIA, and facilities performing only waived tests apply for a Certificate of Waiver.
Section V allows it under three exceptions: a lab not at a fixed location, a not-for-profit or government lab doing limited public health testing (not more than 15 moderate complexity or waived tests in combination), or hospital labs on one campus under common direction.
The instructions say that for a Certificate for PPM, Compliance or Accreditation, an individual can serve as director for no more than five certificates.
