Form CMS-116 is the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification, issued by the Centers for Medicare & Medicaid Services (CMS). Facilities that test human specimens use it to apply for a CLIA certificate, and certified laboratories use it to report changes such as a new certificate type or a new laboratory director. On this page you can fill out the form online on FillingPDF and download or print the completed PDF. The original PDF is published by CMS, and completed applications go to your local State Agency.
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What is CMS-116?
Form CMS-116, the CLIA Application for Certification, is the Centers for Medicare & Medicaid Services (CMS) form on which a laboratory requests a CLIA certificate, or reports a change to an existing one, and describes its testing, volume and ownership.
CMS uses the information to determine the fees to be assessed, to establish baseline data and to meet the statutory requirements of CLIA. The form is approved under OMB No. 0938-0581 and the edition on this page is printed as Form CMS-116 (03/24).
Section II asks you to check only one certificate type:
- Certificate of Waiver, which covers only tests categorized as waived.
- Certificate for Provider Performed Microscopy Procedures (PPM), which covers PPM tests, or PPM and waived tests.
- Certificate of Compliance, which can cover waived, PPM, and moderate or high complexity tests once CLIA quality standards are met after a CLIA survey.
- Certificate of Accreditation, which can cover the same tests when the laboratory is accredited by an approved accreditation organization (The Joint Commission, ACHC, AABB, A2LA, CAP, COLA or ASHI are listed on the form).
After a State Agency processes the application, a fee remittance coupon is issued showing your CLIA identification number and the amount due. Applicants for a Certificate of Compliance or Accreditation first receive a Registration Certificate.
Who needs to file CMS-116?
Every facility that tests human specimens to provide information for the diagnosis, prevention or treatment of disease or impairment, or the assessment of a person's health, is a laboratory under CLIA and applies with this form. CLIA applies even if you perform only one or a few basic tests and even if you do not charge for testing.
- New laboratories check Initial Application and leave the CLIA number blank.
- Existing laboratories use the form to request a change in certificate type, to report a change in laboratory director, or to report other changes such as a change of location or a laboratory closure. Laboratories due for a survey or recertification check Survey.
- Waived-only laboratories are not exempt: facilities performing only waived tests must apply for a Certificate of Waiver.
Facilities that only collect or prepare specimens, or only serve as a mailing service, are not considered laboratories. CLIA does not apply to a facility that performs only forensic testing.
The owner or the laboratory director signs the application. Laboratory directors performing non-waived testing, including PPM, must meet the education, training and experience requirements of subpart M of the CLIA regulations.
When to file CMS-116
Submit Form CMS-116 when you open a laboratory that will test human specimens (initial application) or when something about an existing CLIA certificate changes. For a change in certificate type, check Change in Certificate Type and give the effective date. For any other change, including a new location, a new director or a laboratory closure, check Other Changes, specify it and give the effective date. Check Survey for an initial survey or a recertification.
Base every answer on your laboratory's operation as of the date you complete the form. If you apply for a Certificate of Accreditation, you must give evidence of accreditation, or of an application for it, within 11 months after receiving your Certificate of Registration. The form prints no other filing deadline.
Documents you need
- Laboratory director qualifications, for a Certificate for PPM, Certificate of Compliance or Certificate of Accreditation (and for any director performing non-waived testing): proof of the education, training and experience required under subpart M.
- Verification of State licensure for the laboratory director, as applicable.
- Documentation of director qualifications, such as a diploma or transcript, credentials and laboratory experience.
- An evaluation of credentials showing equivalency to U.S. education, for directors who attended foreign schools; missing it delays processing.
- Evidence of accreditation by an approved accreditation organization, or of application for it, within 11 months after receiving your Certificate of Registration, if you apply for a Certificate of Accreditation.
- A list of temporary testing sites, if you answer Yes to the mobile or temporary location question in Section V.
- Vehicle identification numbers (VINs) of all vehicles used, if a mobile unit provides the testing.
- Site names, addresses and tests performed, if you apply for one certificate covering multiple sites under the exception for public health testing or hospital campuses.
- Additional pages in the same format, if you check the box for more space in Section IV, V, VI, VII or VIII.
How to fill out CMS-116
Identify the application type
In Section I, check Initial Application, Survey, Change in Certificate Type, Change in Laboratory Director or Other Changes (specify), with the effective date for changes. Leave the CLIA identification number blank for an initial application; otherwise enter the 10-digit number on your CLIA certificate.
Enter facility and contact details
Give the facility name (it appears on your certificate), federal tax identification number, email, telephone and fax with area codes. Check the email notifications box only if you enter a valid email address.
Complete the addresses
Enter the physical facility address with no P.O. box or Mail Stop. Add an optional mailing/billing or corporate address if you want the fee coupon or certificate sent elsewhere, then pick Physical, Mailing or Corporate for each.
Enter the laboratory director
Write the director's name (Last, First, Middle Initial), credentials and phone number. Leave the For Office Use Only block blank.
Select one certificate type
In Section II, check one: Certificate of Waiver, PPM, Compliance or Accreditation. For Accreditation, mark the accrediting organization and note the sections each type requires.
Choose the type of laboratory
In Section III, check the one code that best describes the facility, such as 21 Physician Office or 14 Hospital. Specify for 22 Practitioner Other or 29 Other; attach VINs on a separate sheet for 19 Mobile Laboratory.
List hours of testing
In Section IV, enter FROM and TO times for each day in HH:MM format, without military time. Check the 24/7 box if testing is continuous.
Answer the multiple sites question
In Section V, answer whether one certificate will cover multiple testing locations. If Yes, answer questions 1 to 3 and list each site's name, address and tests.
Describe waived and PPM testing
In Section VI, list each waived analyte, test name and manufacturer and the estimated total annual volume. In Section VII, mark each PPM procedure and give the annual PPM volume, or check the box if none is performed.
Report non-waived testing
For a Certificate of Compliance or Accreditation, complete Section VIII: list tests with M or H, check each specialty and enter annual test volume and the total. Name the accrediting organization for each accredited specialty.
Complete control and director affiliation
In Section IX, check the ownership type and answer the foreign ownership question, giving the country if Yes. In Section X, list the CLIA number and name of other separately certified laboratories the director serves.
Review, sign and download the PDF
Print the director's and owner's names, sign and date with ink or a secure electronic signature, and check that all applicable sections are complete. Download or print the completed PDF from FillingPDF and send it to your State Agency as described under How to submit.
How to submit CMS-116
Send the completed Form CMS-116 to your local State Agency. There is no payment to include with it.
- State Agency: contact details are in the CLIA State Agency list at https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA.pdf. Call the State Agency if you have questions about completing the form.
- Fees: do not send any money with the application. Once the State Agency processes it, a fee remittance coupon is issued with your CLIA identification number and the amount due; it goes to the address you chose in Section I.
- Attachments: include laboratory director qualifications where required, any lists the multiple-site section calls for, and any extra pages needed for test tables.
- Signature: sign in ink or use a secure electronic signature.
Do not send applications or documents containing sensitive information to the CMS PRA Reports Clearance Officer; that office handles only comments on the time estimate. FillingPDF lets you fill out and download the PDF; submission follows the channels above.
Common mistakes to avoid
- Sending the application with sections left blank; the instructions say incomplete applications cannot be processed and will be returned to the facility.
- Entering a P.O. box or Mail Stop as the facility address; the physical address must be where testing is performed.
- Sending payment with the application; the fee is paid later using the coupon issued after processing.
- Mailing the form to CMS's PRA Reports Clearance Office instead of your local State Agency.
- Checking more than one box in Section II; only one certificate type may be selected.
- Applying for a Certificate of Waiver when the laboratory performs non-waived tests; a Certificate of Waiver covers only waived tests.
- Counting waived tests, calculations, quality control, quality assurance or proficiency testing in the estimated annual volume for specialties.
- Using military time in Section IV; the form requires HH:MM format and a 24/7 check box for continuous testing.
- Checking the email notifications box without entering a valid email address.
- Claiming multiple sites under one certificate without meeting one of the three regulatory exceptions in Section V.
Frequently asked questions
What is Form CMS-116 used for?
Form CMS-116 is the CLIA Application for Certification. A laboratory uses it to request a CLIA certificate (Waiver, PPM, Compliance or Accreditation) or to report changes such as certificate type, laboratory director, location or closure. It also collects the data CMS uses to determine fees.
Where do I send Form CMS-116?
Send the completed form to your local State Agency. Contact information is in the CLIA State Agency list at https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA.pdf. Do not send it to the CMS PRA Reports Clearance Office.
Do I pay a fee when I submit the CLIA application?
No. The form says not to send any payment with the application. After the State Agency processes it, a fee remittance coupon is issued showing your CLIA number and the amount due. Contact your State Agency for current fee questions.
Do I need a CLIA certificate if I only do waived tests?
Yes. Waived tests are not exempt from CLIA. A facility performing only waived tests must apply for a Certificate of Waiver, and it can then perform only tests categorized as waived.
Which certificate type should I choose on Form CMS-116?
Choose by the highest level of test complexity your laboratory performs. A laboratory doing non-waived tests picks a Certificate of Compliance or a Certificate of Accreditation, depending on whether it wants a CLIA survey or is accredited by an approved organization.
Do I enter a CLIA number on the form?
Only if you are not an initial applicant. For an initial application leave the number blank; it is assigned when the application is processed. Otherwise enter the 10-digit CLIA identification number listed on your CLIA certificate.
What must I attach for the laboratory director?
For a Certificate for PPM, Compliance or Accreditation, include proof of the director's qualifications: State licensure verification as applicable, documentation such as a diploma or transcript, credentials and laboratory experience. Foreign-educated directors need an equivalency evaluation.
How do I count tests for annual volume?
Follow the counting guidelines in the instructions: for chemistry each non-calculated analyte counts separately, and a lipid panel of four analytes equals four tests. Do not count calculations, quality control, quality assurance or proficiency testing.
Can I fill out Form CMS-116 online on FillingPDF?
Yes. You can fill out the PDF online on FillingPDF and download or print it. FillingPDF is an independent service and does not submit the application to CMS or a State Agency; you send it through the State Agency yourself.
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