Form CMS-116 at a glance
What it is: Form CMS-116 is the Clinical Laboratory Improvement Amendments (CLIA) application for certification.
Where and when to file: NOTE: Completed 116 applications must be sent to your local State Agency.
Under Form CMS-116, CLIA requires every facility that tests human specimens for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, a human being to meet certain Federal requirements. If your facility performs tests for these purposes, it is considered, under the law, to be a laboratory.
What to bring and attach to Form CMS-116
Information to be submitted with the application include: Verification of State Licensure, as applicable
Individuals who attended foreign schools must have an evaluation of their credentials determining equivalency of their education to education obtained in the United States.
A filled-in Form CMS-116 example: a new laboratory applies for a Certificate of Waiver
How to fill out Form CMS-116, box by box
Type of application
For an initial applicant, check “initial application”.
For an initial survey or for a recertification, check “survey”.
For a request to change the type of certificate, check “change in certificate type” and provide the effective date of the change.
For all other changes, including change in location, director, lab closure, etc., check “other changes” and provide the effective date of the change.
CLIA identification number
For an initial applicant, the CLIA number should be left blank. The number will be assigned when the application is processed. For all other applicants, enter the 10 digit CLIA identification number already assigned and listed on your CLIA certificate.
Facility name and email address
Be specific when indicating the name of your facility, particularly when it is a component of a larger entity, e.g., respiratory therapy department in XYZ Hospital. For a physician's office, this may be the name of the physician. NOTE: the information provided is what will appear on your certificate.
A valid Email Address will be used for communications between the CLIA program and the laboratory. Selecting the Receive notifications including electronic certificates via email checkbox requires the laboratory to enter a valid Email Address.
Facility, mailing and corporate addresses
The Physical Facility Address is mandatory and must reflect the physical location where the laboratory testing is performed. The address may include a floor, suite and/or room location, but cannot be a Post Office box or Mail Stop.
The Mailing Address is optional and may be used if the laboratory wants to direct the mailing of the CLIA fee coupon and/or CLIA certificate to an alternate location. A Post Office box number or Mail Stop number may be used as part of the Mailing Address for this section.
The Corporate Address is optional and may be used if the laboratory wants to direct the mailing of the CLIA fee coupon and/or CLIA certificate to another location, such as the main headquarters or home office for the laboratory.
Select the address (Physical, Mailing, Corporate) where the CLIA fee coupon and CLIA certificate are to be mailed.
Laboratory director
NOTE: Laboratory directors performing non-waived testing (including PPM) must meet specific education, training and experience under subpart M (42 CFR PART 493) of the CLIA requirements. Proof of these requirements for the laboratory director must be submitted with the application.
Type of certificate requested
Select your certificate type based on the highest level of test complexity performed by your laboratory.
Note: waived tests are not exempt from CLIA. Facilities performing only those tests categorized as waived must apply for a CLIA Certificate of Waiver.
Certificate of Waiver (Complete Sections I - VI and IX - X)
Certificate for Provider Performed Microscopy Procedures (PPM) (Complete Sections I-VII and IX-X)
Certificate of Compliance (Complete Sections I - X)
Certificate of Accreditation (Complete Sections I - X) and indicate which of the following organization(s) your laboratory is accredited by for CLIA purposes, or for which you have applied for accreditation for CLIA purposes.
If you are applying for a Certificate of Accreditation, you must provide evidence of accreditation for your laboratory by an approved accreditation organization for CLIA purposes or evidence of application for such accreditation within 11 months after receipt of your Certificate of Registration.
Type of laboratory
Select the type that is most descriptive of the location where the laboratory testing is performed.
Hours of laboratory testing
Provide only the times when actual laboratory testing is performed in your facility.
Please use the HH:MM format and check box marked ‘24/7' if laboratory testing is performed continuously, e.g., 24 hours a day, 7 days a week. Do not use military time.
Multiple sites
You can only qualify for the multiple site provision (more than one site under one certificate) if you meet one of the CLIA requirements described in 42 CFR 493.
Are you applying for a single site CLIA certificate to cover multiple testing locations? If no, go to section VI. If yes, complete the remainder of this section.
Waived testing
If only applying for a Certificate of Waiver, complete this section and skip sections VII (PPM Testing) and VIII (Non-Waived Testing).
Identify the waived testing (to be) performed by completing the table. Include each analyte, test system, or device used in the laboratory.
Indicate the estimated total annual test volume for all waived tests performed.
PPM testing
If only applying for a Certificate for PPM, complete this section and skip section VIII (Non-Waived Testing).
Mark the checkbox by each PPM procedure(s) to be performed.
Indicate the estimated total annual test volume for all PPM tests performed.
Non-waived testing
(Including PPM testing if applying for a Certificate of Compliance or Certificate of Accreditation) Complete this section only if you are applying for a Certificate of Compliance or a Certificate of Accreditation.
Identify the non-waived testing (to be) performed by completing the table. Be as specific as possible. This includes each analyte, test system, or device used in the laboratory. Use (M) for moderate complexity and (H) for high complexity.
Place a check (3) in the box preceding each specialty/subspecialty in which the laboratory performs testing. Enter the estimated annual test volume for each specialty. Do not include testing not subject to CLIA, waived tests, or tests run for quality control, calculations, quality assurance or proficiency testing when calculating test volume.
The total Estimated Annual Test volume in this section includes all non-waived testing, including PPM tests previously counted in section VII.
Type of control
Select the type of ownership or control which most appropriately describes your facility.
Does this facility have partial or full ownership or control by a non-United States-based government or entity?
If Yes, what is the country of origin for the foreign entity?
Director of additional laboratories
If the director of this laboratory serves as director for additional laboratories that are separately certified, please complete the following:
List all other facilities, including Certificate of Waiver, for which the director is responsible and that are under different certificates.
Note that 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.
Signing the application
Read the following carefully before signing application. Signature of owner/director of laboratory (sign in ink or use a secure electronic signature) and Date.
Owner means any person who owns any interest in a laboratory except for an interest in a laboratory whose stock and/or securities are publicly traded.
More rules for Form CMS-116
ALL APPLICABLE SECTIONS MUST BE COMPLETED. INCOMPLETE APPLICATIONS CANNOT BE PROCESSED AND WILL BE RETURNED TO THE FACILITY. PRINT LEGIBLY OR TYPE INFORMATION.
Facilities that are not considered laboratories
Your facility only collects or prepares specimens, only serves as a mailing service or only performs forensic testing
Facilities only collecting or preparing specimens (or both) or only serving as a mailing service are not considered laboratories. CLIA does not apply to a facility that only performs forensic testing. CLIA applies even if only one or a few basic tests are performed, and even if you are not charging for testing.
Common questions about Form CMS-116
Where do I file it?
Send the completed Form CMS-116 to the appropriate State Agency.
Are there fees?
In addition, the CLIA legislation requires financing of all regulatory costs through fees assessed to affected facilities. Do not send any payment with your completed 116 application.
Is there a penalty?
Any person who intentionally violates any requirement of section 353 of the Public Health Service Act as amended or any regulation promulgated thereunder shall be imprisoned for not more than 1 year or fined under title 18, United States Code or both, except that if the conviction is for a second or subsequent violation of such a requirement such person shall be imprisoned for not more than 3 years or fined in accordance with title 18, United States Code or both.
Sources
[1] Form CMS-116 (03/24), Clinical Laboratory Improvement Amendments (CLIA) Application for Certification, Centers for Medicare & Medicaid Services (the Official source link on this page).
