Form CMS-116 CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) - Appl

U.S. Department of Health and Human Services
Centers for Medicare & Medicaid Services

Form Approved
OMB No. 0938-0581
Expires: XX/XXXX

Clinical Laboratory Improvement Amendments (CLIA) Application
(Form CMS-116)
Clinical Laboratory Improvement Amendments (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, or the
assessment of the health, of a human being to meet certain federal requirements.
If your facility performs tests for these purposes, it’s considered under the law to be a laboratory. CLIA applies even
if your laboratory performs only one or a few basic tests, and even if you’re not charging for testing. The CLIA
legislation requires financing of all regulatory costs through fees assessed to affected facilities.
The CLIA application (Form CMS-116) collects information about your laboratory’s operation to determine the fees to
be assessed, establish baseline data, and fulfill the statutory requirements for CLIA. This information will also provide
an overview of your facility’s laboratory operation. Any information you submit should be based on your facility’s
laboratory operation as of the date you complete the form.
Note: Waived tests aren’t exempt from CLIA. Facilities that only perform tests categorized as waived must apply for
a CLIA certificate of waiver. Specific test system categorizations can also be found at:
Accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/clia.cfm
Facilities that only collect or prepare specimens (or both) or only serve as a mailing service aren’t considered
laboratories. CLIA doesn’t apply to a facility that only performs forensic testing.
Proof of laboratory director qualifications must be submitted with this form. Documentation must include:
• Verification of State Licensure, as applicable
• Documentation of qualifications:
• Documentation to show CLIA personnel qualifications are met (e.g., diploma, transcript)
• Credentials
• Laboratory experience
People who attended foreign schools must have their credentials evaluated to determine U.S. education equivalency.
Failure to submit this information will delay the processing of your application.

How to submit Form CMS-116
• Include the current or estimated annual test volume
• For Certificate for Provider-performed Microscopy (PPM) Procedures, Certificate of Compliance, or Certificate of
Accreditation, include laboratory director qualifications
• Don’t send any money with your form
• Send your completed Form CMS-116 to the appropriate state agency (CMS.gov/Regulations-and-Guidance/
Legislation/CLIA/Downloads/CLIASA.pdf).

What happens next
Once you submit Form CMS-116 and your state agency processes the form, you’ll receive a fee remittance coupon.
The fee remittance coupon will show your CLIA identification number and the amount due for the certificate, and
any compliance (survey) or validation fee that applies.
If you’re applying for a Certificate of Compliance or Certificate of Accreditation, you’ll initially pay for and receive a
Certificate of Registration. A Certificate of Registration permits a facility requesting a Certificate of Compliance to
perform testing until an onsite inspection is conducted to determine program compliance; or for a facility applying
for a Certificate of Accreditation, until CMS receives verification of accreditation by an approved accreditation
organization.

Get help & more information
For more information about CLIA, or if you have questions about this form, contact your state agency. State agency
contact information can be found at:
CMS.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA.pdf

Form CMS-116 (XX/XXXX)

Form Approved
OMB No. 0938-0581
Expires: XX/XXXX

U.S. Department of Health and Human Services
Centers for Medicare & Medicaid Services

Clinical Laboratory Improvement Amendments (CLIA) Application
(Form CMS-116)
For Office Use Only. Date received (mm/dd/yyyy)

Complete all sections that apply. Please type or print legibly.

1. General Information
Initial application
Anticipated start date (mm/dd/yyyy):

Survey
Change in certificate type
Change in laboratory director
Other changes (specify):
Effective date (mm/dd/yyyy):

CLIA Identification Number (leave blank if this is an initial application—a number will be assigned)

D
Facility name

Federal Tax Identification Number (TIN)

Email address 1

Email address 2 (optional)

Email address 3 (optional)

Email address for CLIA fee coupons (if applicable)

Phone number

Fax number

Facility address (physical location—no P.O. Boxes)

Facility address line 2 (building, floor, suite, if applicable)

City

State

ZIP code

Name of Laboratory Director (Last, First, Middle initial)

Laboratory Director phone number

Name of Owner

Owner phone number

Form CMS-116 (XX/XXXX)

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2. Type of Certificate Requested
Check only one. Select your certificate type based on the highest level of test your laboratory performs. A laboratory performing
non-waived tests can choose Certificate of Compliance or Certificate of Accreditation based on the entity you want to survey your
laboratory.
Certificate of Waiver can only perform tests categorized as waived* (complete sections 1–6 and 9–10)
Note: Laboratory directors performing non-waived testing (including PPM) must meet specific education, training and
experience under subpart M of the CLIA regulations. Proof of qualifications for the laboratory director must be submitted
with this form.
Certificate for Provider Performed Microscopy Procedures (PPM) can only perform tests categorized as PPM, or tests
categorized as PPM and waived tests* (complete sections 1–6 and 9–10)
Certificate of Compliance can perform tests categorized as waived, PPM and moderate and/or high complexity tests if the
applicable CLIA quality standards are met after a CLIA survey (complete sections 1–10)
Certificate of Accreditation can perform tests categorized as waived, PPM and moderate and/ or high complexity non-waived
tests if the laboratory is currently accredited by an approved accreditation organization. (complete sections 1–10)
If you’re applying for a Certificate of Accreditation, you must provide evidence of accreditation by an approved accreditation
organization for CLIA purposes, or evidence that you applied for accreditation, within 11 months after you receive your
Certificate of Registration.
Which organization(s) is your laboratory accredited by (or you applied for accreditation from) for CLIA purposes?
The Joint Commission
ACHC
AABB
A2LA
CAP
COLA
ASHI
If your accreditation organization isn’t listed, contact your local state agency for instructions.
*Specific test system categorizations can also be found at: Accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/clia.cfm

3. Type of Laboratory
Check the one that most closely describes your facility type:
01 Ambulance
11 Health Main. Organization
02 Ambulatory Surgery Center*
12 Home Health Agency*
03 Ancillary Testing Site in Health Care
13 Hospice*
Facility
14 Hospital*
04 Assisted Living Facility
15 Independent
05 Blood Bank
16 Industrial
06 Community Clinic
17 Insurance
07 Comp. Outpatient Rehab Facility*
18 Intermediate Care Facilities for
Individuals with Intellectual
08 End Stage Renal Disease Dialysis
Disabilities*
Facility*
09 Federally Qualified Health Center*
19 Mobile Laboratory
10 Health Fair
20 Pharmacy

21 Physician Office
22 Practitioner Other (specify):
23
24
25
26
27

Prison
Public Health Laboratories
Rural Health Clinic*
School/Student Health Service
Skilled Nursing Facility/Nursing
Facility*
28 Tissue Bank/Repositories
29 Other (specify):

Is the laboratory located within a CMS-certified health care facility (facilities with asterisk*)? ...................................

Yes

No

If yes, list CMS Certification Numbers (CCNs):

4. Hours of Laboratory Testing
List times during which laboratory testing is performed in HH:MM format.
Sunday

Monday

Tuesday

Wednesday

Check here if testing 24/7.
Thursday

Friday

Saturday

From:
To:

Form CMS-116 (XX/XXXX)

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5. Multiple Sites
You must have a CLIA certificate for each location unless you meet one of the CLIA exceptions described in 42 CFR 493.35(b)(1-3),
493.43(b)(1-3) and 493.55(b)(1-3).
Are you applying for a single site CLIA certificate to cover multiple testing locations?
No. If no, go to section 6.
Yes. If yes, complete the rest of this section.
Indicate which one of the following regulatory exceptions applies to your facility’s operation.
This is a laboratory that’s not at a fixed location that moves from testing site to testing site (such as a mobile unit providing
laboratory testing, health screening fairs, or other temporary testing locations) and may be covered under the certificate of the
designated primary site or home base, using its address.
If selected, you must include a list of temporary testing sites with this CMS-116 Form. If a mobile unit provides the testing,
record the vehicle identification number(s) (VINs) and attach it to the form.
This is a not-for-profit or Federal, State, or local government laboratory engaged in limited (not more than a combination of
15 moderate complexity or waived tests per certificate) public health testing and filing for a single certificate for multiple sites.
If selected, provide the number of sites under the certificate
and list name, address and test performed for each site
below.
This is a hospital with multiple laboratories located at contiguous buildings on the same campus within the same physical
location or street address and under common direction filing for a single certificate for these locations.
If selected, provide the number of sites under this certificate
and list name or department, location within hospital and
specialty/subspecialty areas performed at each site below.
1. Name of laboratory or hospital department

Address/Location (number and street, P.O. Box, or route) (if applicable)

City

State

ZIP code

State

ZIP code

Phone number

Tests performed/specialty/subspecialty

2. Name of laboratory or hospital department

Address/Location (number and street, P.O. Box, or route) (if applicable)

City

Phone number

Tests performed/specialty/subspecialty

Need more space?

Form CMS-116 (XX/XXXX)

Check here and attach the additional information using the same format.

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6. Waived Testing to Be Performed
If only applying for a Certificate of Waiver, complete this section and skip sections 7 (PPM Testing to Be Performed) and 8
(Non-Waived Testing to Be Performed).
Include each analyte, test system, or device used in the laboratory.
Analyte/Test
Example: Streptococcus group A

Test Name
Ace Rapid Strep Test

Manufacturer
Acme Corporation

Indicate the Estimated Total Annual Test volume for all waived tests performed:
Check if no waived tests are performed
Need more space?

Check here and attach the additional information using the same format.

7. PPM Testing to Be Performed
If only applying for a Certificate for PPM, complete this section and skip section 8 (Non-Waived Testing).
Listed below are the only PPM tests that can be performed by a facility with a Certificate for PPM. Mark each PPM procedure that
will be performed.
Direct wet mount preparations for the presence or absence of bacteria, fungi, parasites, and human cellular elements
Potassium hydroxide (KOH) preparations
Pinworm examinations
Fern tests
Post-coital direct, qualitative examinations of vaginal or cervical mucous
Urine sediment examinations
Nasal smears for granulocytes
Fecal leukocyte examinations
Qualitative semen analysis (limited to the presence or absence of sperm and detection of motility)
Indicate the Estimated Total Annual Test volume for all PPM tests performed:
If also performing waived complexity tests, complete section 6. For laboratories applying for a Certificate of Compliance or
Certificate of Accreditation, include PPM test volume in the specialty/subspecialty category and the “total estimated annual test
volume” in section 8.
Check if no PPM tests are performed

Form CMS-116 (XX/XXXX)

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8. Non-Waived Testing to Be Performed
Complete this section only if you’re applying for a Certificate of Compliance or a Certificate of Accreditation.
Be as specific as possible, including each analyte, test system, or device used in the laboratory. Use (M) for moderate complexity
and (H) for high complexity. Specific test system categorizations can be found at: Accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/
clia.cfm
Analyte/Test
Example: Potassium

Need more space?

Test Name

Manufacturer

Quick Potassium Test

Acme Corporation

M or H
M

Check here and attach the additional information using the same format.

Non-waived test volumes
The Total Estimated Annual Test Volume in this section includes all non-waived testing, including PPM tests previously counted in
section 7.
If you perform testing other than or in addition to waived tests, complete the information below. If applying for one certificate
for multiple sites, the total volume should include testing for ALL sites.
• Check the box for each specialty/subspecialty in which the laboratory performs testing.
• Enter the estimated annual test volume for each specialty.
• Don’t include testing not subject to CLIA, waived tests, or tests run for quality control, calculations, quality assurance or
proficiency testing when calculating test volume. Go to Guidelines for Counting Tests on page 9 for more details.
• If applying for a Certificate of Accreditation, indicate the name of the Accreditation Organization beside the specialty/
subspecialty for which you’re accredited for CLIA compliance. (The Joint Commission, ACHC, AABB, A2LA, CAP, COLA, or ASHI)
• The Accrediting Organization column should reflect accreditation information for CLIA purposes only; e.g., CAP, etc.
Specialty/
Subspecialty
Histocompatibility 010
Transplant
Nontransplant
Microbiology

Accrediting
Organization

Annual
Test Volume

Specialty/
Subspecialty
Hematology 400
Hematology
Immunohematology
ABO Group & Rh Group 510

Bacteriology 110

Antibody Detection (transfusion) 520

Mycobacteriology 115

Antibody Detection (nontransfusion) 530

Mycology 120

Antibody Identification 540

Parasitology 130
Virology 140

Compatibility Testing 550
Pathology

Diagnostic Immunology

Histopathology 610

Syphilis Serology 210

Oral Pathology 620

General Immunology 220
Chemistry
Routine 310
Urinalysis 320
Endocrinology 330
Toxicology 340

Form CMS-116 (XX/XXXX)

Accrediting
Annual
Organization Test Volume

Cytology 630
Radiobioassay 800
Radiobioassay
Clinical Cytogenetics 900
Clinical Cytogenetics
Total Estimated Annual Test Volume:

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9. Type of Control
Check the one most descriptive of ownership type:
Voluntary Nonprofit:
01 Religious Affiliation

For Profit:
04 Proprietary

Government:
05 City

02 Private Nonprofit

06 County

03 Other Nonprofit (specify):

07 State
08 Federal
09 Other Government:
(If 09 is selected, please specify the country/province.)

Does this facility have partial or full ownership or control by a non-United States-based government or entity? ...

Yes

No

If yes, what is the country of origin for the foreign entity?

10. Director Affiliation with Other Laboratories
If the director of this laboratory serves as director for additional laboratories that are separately certified, complete this section.
Note: For a Certificate for PPM, Certificate of Compliance or Certificate of Accreditation an individual can serve as the director for
no more than five certificates.
CLIA Number

Name of Laboratory

ATTENTION: Read carefully before signing
Any person who is convicted of intentionally violating any CLIA requirements under section 353(1) of the Public Health Service Act
may be imprisoned or fined or both.
Consent: The applicant agrees that the laboratory identified in this application will be operated according to the standards set by
the Secretary of Health and Human Services to carry out the purposes of section 353 of the Public Health Service Act as amended.
The applicant agrees to permit the Secretary, or any designated Federal officer or employee, to inspect the laboratory and its
operations and its pertinent records at any reasonable time, and to furnish any requested information or materials necessary to
determine the laboratory’s eligibility for its certificate or compliance with CLIA requirements.
Note: “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. (The purchase of shares of stock or securities on the New York Stock Exchange in a corporation
owning a laboratory would not make a person an owner for the purpose of this regulation.)
Print name of Laboratory Director/Owner

Signature of Laboratory Director/Owner (sign in ink or use a secure electronic signature)

Date signed (mm/dd/yyyy)

How to submit your form
Send your completed Form CMS-116 to your local state agency. Don’t send any payment with your form.
Find your state agency contact information at: CMS.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA.pdf

Form CMS-116 (XX/XXXX)

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Tests Commonly Performed and their Corresponding Laboratory Specialties/Subspecialties
Histocompatibility (010)
• HLA Typing (disease associated antigens)

Microbiology
Bacteriology (110)
• Gram Stain
• Culture
• Susceptibility
• Strep screen
• Antigen assays (H.pylori, Chlamydia, etc.)
Mycobacteriology (115)
• Acid Fast Smear
• Mycobacterial culture
• Mycobacterial susceptibility
Mycology (120)
• Fungal Culture
• DTM
• KOH Preps
Parasitology (130)
• Direct Preps
• Ova and Parasite Preps
• Wet Preps
Virology (140)
• RSV (Not including waived kits)
• HPV assay
• Cell culture

Diagnostic immunology
Syphilis Serology (210)
• RPR
• FTA, MHATP
General Immunology (220)
• Allergen testing
• ANA
• Antistreptolysin O
• Antibody (herpes, rubella, etc.)
• Complement (C3, C4)
• Hepatitis (Antigen/Antibody)
• HIV (Antigen/Antibody)
• Immunoglobulin
• Mononucleosis assay
• Rheumatoid factor
• Tumor marker (AFP, CA 19-9, CA 15-3, CA 125)*

Hematology (400)
• Complete Blood Count (CBC)
• WBC count
• RBC count
• Hemoglobin
• Hematocrit (Not including spun micro)
• Platelet count
• Differential
• Activated Clotting Time
• Prothrombin time (Not including waived instruments)
• Partial thromboplastin time
• Fibrinogen
• Reticulocyte count
• Manual WBC by hemocytometer
• Manual platelet by hemocytometer
• Manual RBC by hemocytometer
• Sperm count

Immunohematology
•
•
•
•
•

ABO group (510)
Rh(D) type (510)
Antibody screening
Antibody identification (540)
Compatibility testing (550)

Pathology
•
•
•
•
•

Dermatopathology
Oral Pathology (620)
PAP smear interpretations (630)
Other Cytology tests (630)
Histopathology (610)

Radiobioassay (800)
• Red cell volume
• Schilling test

Clinical Cytogenetics (900)
• Fragile X
• Buccal smear
• Prader-Willi syndrome
• FISH studies for: neoplastic disorders, congenital
disorders or solid tumors.

* Tumor markers can alternatively be listed under
Routine Chemistry instead of General Immunology.

Form CMS-116 (XX/XXXX)

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Chemistry
Routine Chemistry (310)
• Albumin
• Ammonia
• Alk Phos
• ALT/SGPT
• AST/SGOT
• Amylase
• Bilirubin
• Blood gas (pH, pO2, pCO2)
• BUN
• Calcium
• Chloride
• Cholesterol
• Cholesterol, HDL
• CK/CK isoenzymes
• CO2
• Creatinine
• Ferritin
• Folate
• GGT
• Glucose (Not fingerstick)
• Iron
• LDH/LDH isoenzymes
• Magnesium
• Potassium
• Protein, electrophoresis
• Protein, total
• PSA
• Sodium
• Triglycerides
• Troponin
• Uric acid
• Vitamin B12

Toxicology (340)
• Acetaminophen
• Blood alcohol
• Blood lead (Not waived)
• Carbamazepine
• Digoxin
• Ethosuximide
• Gentamicin
• Lithium
• Phenobarbital
• Phenytoin
• Primidone
• Procainamide
• NAPA
• Quinidine
• Salicylates
• Theophylline
• Tobramycin
• Therapeutic Drug Monitoring
Urinalysis** (320)
• Automated Urinalysis (Not including waived
instruments)
• Microscopic Urinalysis
• Urine specific gravity by refractometer
• Urine specific gravity by urinometer
• Urine protein by sulfosalicylic acid
** Dipstick urinalysis is counted in section 6 (Waived
Testing to Be Performed)

Endocrinology (330)
• Cortisol
• HCG (serum pregnancy test)
• T3
• T3 Uptake
• T4
• T4, free
• TSH

Note: This is not a complete list of tests covered by CLIA. Contact your State agency for more information.
State agency contact information can be found at:
CMS.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA.pdf

Form CMS-116 (XX/XXXX)

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Guidelines for Counting Tests for CLIA
• For chemistry, each non-calculated analyte is counted separately (e.g., Lipid Panel consisting of a total cholesterol,
HDL cholesterol, LDL cholesterol and triglycerides equals 4 tests).
• For clinical cytogenetics, the number of tests is determined by the number of specimen types processed on each
patient; e.g., a bone marrow and a venous blood specimen received on one patient is counted as
two tests. NOTE: For all other genetic tests, the number of tests is determined by the number of results reported in
the final report.
• For manual gynecologic and nongynecologic cytology, each slide (not case) is counted as one test.
• For flow cytometry, each measured individual analyte (e.g. T cells, B cells, CD4, etc.) that is ordered and reported
should be counted separately.
• For general immunology, testing for allergens should be counted as one test per individual allergen.
• Genetics testing platforms are used in many of the testing specialties/subspecialties. The laboratory should select
the specialty or subspecialty according to the analyte the test is identifying.
• For hematology, each measured individual analyte of a complete blood count or flow cytometry test that is
ordered and reported is counted separately. The WBC differential is counted as one test.
• For histocompatibility, each HLA typing (including disease associated antigens) is counted as one test, each HLA
antibody screen is counted as one test and each HLA crossmatch is counted as one test. For example, a B-cell, a
T-cell, and an auto-crossmatch between the same donor and recipient pair would be counted as 3 tests.
• For histopathology, each block (not slide) is counted as one test. Autopsy services are not included. For
those laboratories that perform special stains on histology slides, the test volume is determined by adding
the number of special stains performed on slides to the total number of specimen blocks prepared by
the laboratory.
• For immunohematology, each ABO, Rh, antibody screen, crossmatch or antibody identification is counted as
one test.
• For microbiology, susceptibility testing is counted as one test per group of antibiotics used to determine sensitivity
for one organism. Cultures are counted as one per test request from each specimen regardless of the extent of
identification, number of organisms isolated, and number of tests/procedures required for identification. Each
gram stain or acid-fast bacteria (AFB) smear requested from the primary source is counted as one. For example,
if a sputum specimen has a routine bacteriology culture and gram stain, a mycology test, and an AFB smear and
culture ordered, this would be counted as five tests. For parasitology, the direct smear and the concentration and
prepared slide are counted as one test.
• For urinalysis, microscopic and macroscopic examinations, each count as one test. Macroscopics (dipsticks) are
counted as one test regardless of the number of reagent pads on the strip.
• For all specialties/subspecialties, do not count calculations (e.g., A/G ratio, MCH, T7, etc.), quality control, quality
assurance, or proficiency testing assays.
If you need additional information concerning counting tests for CLIA, please contact your state agency.

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unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0938-0581. Expiration Date:
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instructions, search existing data resources, gather the data needed, and complete and review the information collection. If you have comments
concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn:
PRA Reports Clearance Officer, Mail Stop C4-26-05, Baltimore, Maryland 21244-1850. *****CMS Disclaimer*****Please do not send applications,
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CMS.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA.pdf.
Form CMS-116 (XX/XXXX)

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