Form CMS-116 Clinical Laboratory Improvement Amendments (CLIA) Applic

DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES

Form Approved
omb no. 0938-0581

clinical laboratory improvement amendments (CLIA)
application for certification
I. GENERAL INFORMATION
Initial Application

Survey

Change in Certification Type

CLIA Identification Number
_______________D________________________

Other Changes (Specify)

(If an initial application leave blank, a number will be assigned)

Facility Name

Federal Tax Identification Number

Email Address

Telephone No. (Include area code)

Facility Address — Physical Location of Laboratory (Building, Floor, Suite
if applicable.) Fee Coupon/Certificate will be mailed to this Address unless
mailing address is specified

Mailing/Billing Address (If different from street address)

NUMBER, STREET (No P.O. Boxes)

NUMBER, STREET

CITY

STATE

ZIP CODE

Name of Director (Last, First, Middle Initial)

CITY

Fax No. (Include area code)

STATE

ZIP CODE

For Office Use Only

Date Received ____________________________________________________

II. TYPE OF CERTIFICATE REQUESTED (Check only one)
Certificate of Waiver (Complete Sections I – VI and IX – X)
Certificate for Provider Performed Microscopy Procedures (PPM) (Complete Sections I – 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

The Joint Commission

AOA

AABB

CAP

COLA

ASHI

If you are applying for a Certificate of Accreditation, you must provide evidence of accreditation for your
laboratory by an approved accreditation organization as listed above for CLIA purposes or evidence of application
for such accreditation within 11 months after receipt of your Certificate of Registration.
Note: Laboratory directors performing non-waived testing (including PPM) must meet specific education,
training and experience under subpart M of the CLIA requirements. Proof of these requirements for the
laboratory director must be submitted with the application.

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a
valid OMB control number. The valid OMB control number for this information collection is 0938-0581. The time required to complete this
information collection is estimated to average 30 minutes to 2 hours per response, including the time to review instructions, search existing
data resources, gather the data needed, and complete and review the information collection. If you have any comments concerning the
accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS, Attn: PRA Reports Clearance Officer,
7500 Security Boulevard, Baltimore, Maryland 21244-1850.
Form CMS-116 (10/10)

1

IIi. TYPE OF laboratory (Check the one most descriptive of facility type)
01 Ambulance

11 Health Main. Organization

02 Ambulatory Surgery Center

12 Home Health Agency

03 Ancillary Testing Site in

Health Care Facility

22 Practitioner Other (Specify)
______________________________

13 Hospice

23 Prison

14 Hospital

24 Public Health Laboratories

04 Assisted Living Facility

15 Independent

25 Rural Health Clinic

05 Blood Bank

16 Industrial

26 School/Student Health Service

06 Community Clinic

17 Insurance

07 Comp. Outpatient Rehab Facility
08 End Stage Renal Disease

Dialysis Facility

18 Intermediate Care Facility for

Mentally Retarded

09 Federally Qualified

Health Center

28 Tissue Bank/Repositories

19 Mobile Laboratory

29 Other (Specify)

20 Pharmacy
21 Physician Office
Is this a shared lab?

10 Health Fair

27 Skilled Nursing Facility/

Nursing Facility

Yes

______________________________

No

IV. Hours of laboratory testing (List times during which laboratory testing is performed in HH:MM format)
sunday

monday

tuesday

wednesday

thursday

friday

saturday

From:
To:
(For multiple sites, attach the additional information using the same format.)

V. multiple sites (must meet one of the regulatory exceptions to apply for this provision)
Are you applying for the multiple site exception?
No. If no, go to section VI.

Yes. If yes, complete remainder of this section.

Indicate which of the following regulatory exceptions applies to your facility’s operation.
1. Is this a laboratory that has temporary testing sites?
Yes

No

2. Is this 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?
Yes

No

If yes, provide the number of sites under the certificate____________ and list name, address and test performed for each
site below.
3. Is this a hospital with several laboratories located at contiguous buildings on the same campus within the same physical
location or street address and under common direction that is filing for a single certificate for these locations?
Yes

No

If yes, 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.

If additional space is needed, check here

and attach the additional information using the same format.

name and address/location

tests performed/specialty/subspecialty

NAME OF LABORATORY OR HOSPITAL DEPARTMENT

ADDRESS/LOCATION (Number, Street, Location if applicable)

CITY, STATE, ZIP CODE

Telephone No. (Include area code)

NAME OF LABORATORY OR HOSPITAL DEPARTMENT

ADDRESS/LOCATION (Number, Street, Location if applicable)

CITY, STATE, ZIP CODE

Form CMS-116 (10/10)

Telephone No. (Include area code)

2

In the next three sections, indicate testing performed and annual test volume.

Vi. waived testing
Identify the waived testing performed. Be as specific as possible. This includes each analyte test system or device used in
the laboratory.
e.g. (Rapid Strep, Acme Home Glucose Meter)

Indicate the estimated TOTAL ANNUAL TEST volume for all waived tests performed ________________
Check if no waived tests are performed

VII. PPM TESTING
Identify the PPM testing performed. Be as specific as possible.
e.g. (Potassium Hydroxide (KOH) Preps, Urine Sediment Examinations)

Indicate the estimated TOTAL ANNUAL TEST volume for all PPM tests performed ________________
For laboratories applying for certificate of compliance or certificate of accreditation, also include PPM test volume in the
“total estimated test volume” in section VIII.
Check if no PPM tests are performed
If additional space is needed, check here

and attach additional information using the same format.

ViII. non-waived testing (Including PPM testing)
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.
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. (For additional guidance on counting
test volume, see the information included with the application package.)
If applying for a Certificate of Accreditation, indicate the name of the Accreditation Organization beside the applicable specialty/
subspecialty for which you are accredited for CLIA compliance. (The Joint Commission, AOA, AABB, CAP, COLA or ASHI)
specialty /
subspecialty

accrediting
ANNUAL
organization test volume

Histocompatibility
Transplant
Nontransplant
Microbiology

specialty /
subspecialty
Hematology
Hematology
Immunohematology
ABO Group & Rh Group

Bacteriology

Antibody Detection (transfusion)

Mycobacteriology

Antibody Detection (nontransfusion)

Mycology

Antibody Identification

Parasitology

Compatibility Testing

Virology
Diagnostic Immunology

Pathology
Histopathology

Syphilis Serology

Oral Pathology

General Immunology

Cytology

Chemistry
Routine
Urinalysis
Endocrinology
Toxicology
Form CMS-116 (10/10)

accrediting
ANNUAL
organization test volume

Radiobioassay
Radiobioassay
Clinical Cytogenetics
Clinical Cytogenetics

Total estimated annual test volume:
3

IX. type of control
Voluntary Nonprofit

01 Religious Affiliation

For profit

04 Proprietary

Government

05 City

02 Private Nonprofit

06 County

03 Other Nonprofit

07 State
08 Federal

(Specify)

_

09 Other Government
_

(Specify)

X. DIRECTOR affiliation with other laboratories
If the director of this laboratory serves as director for additional laboratories that are separately certified, please
complete the following:
CLIA Number

NAME OF LABORATORY

Attention: Read the following carefully before signing application
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.
Consent: The applicant hereby agrees that such laboratory identified herein will be operated in accordance with
applicable standards found necessary 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 further agrees to permit the Secretary,
or any Federal officer or employee duly designated by the Secretary, 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 or continued eligibility for its certificate or continued compliance with
CLIA requirements.
signature of OWNER/director OF LABORATORY (Sign in ink)

Form CMS-116 (10/10)

date

4

THE CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) APPLICATION
(FORM CMS-116)
INSTRUCTIONS FOR COMPLETION
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. CLIA applies even if only one or a few basic tests are performed, and even if you are
not charging for testing. In addition 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 which is necessary to
determine the fees to be assessed, to establish baseline data and to fulfill the statutory requirements for CLIA. This
information will also provide an overview of your facility’s laboratory operation. All information submitted should
be based on your facility’s laboratory operation as of the date of form completion.
NOTE: WAIVED TESTS ARE NOT EXEMPT FROM CLIA. FACILITIES PERFORMING ONLY THOSE TESTS CATEGORIZED
AS WAIVED MUST APPLY FOR A CLIA CERTIFICATE OF WAIVER.
NOTE: Laboratory directors performing non-waived testing (including PPM) must meet specific education, training
and experience under subpart M of the CLIA requirements. Proof of these requirements for the laboratory
director must be submitted with the application. Information to be submitted with the application include:
• Verification of State Licensure, as applicable
• Documentation of qualifications:

Education (copy of Diploma, transcript from accredited institution, CMEs),

Credentials, and

Laboratory experience.
Individuals who attended foreign schools must have an evaluation of their credentials determining equivalency
of their education to education obtained in the United States. Failure to submit this information will delay the
processing of your application.
ALL APPLICABLE SECTIONS MUST BE COMPLETED. INCOMPLETE APPLICATIONS CANNOT BE PROCESSED AND WILL
BE RETURNED TO THE FACILITY. PRINT LEGIBLY OR TYPE INFORMATION.

I. GENERAL INFORMATION

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”. For all other changes, including
change in location, director, etc., check “other changes”.
For an initial applicant, the CLIA number should be left blank. The number will be assigned when the application
is processed. 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.
Facility street address must be the actual physical location where testing is performed, including floor, suite and/
or room, if applicable. DO NOT USE A POST OFFICE BOX NUMBER OR A MAIL DROP ADDRESS FOR THE NUMBER
AND STREET OF THE ADDRESS. If the laboratory has a separate mailing address, please complete that section of
the application.
NOTE: For Office Use Only—Date received is the date the form is received by the state agency or CMS regional
office for processing.

Form CMS-116 (10/10)

Instructions

II. TYPE OF CERTIFICATE REQUESTED

When completing this section, please remember that a facility holding a:
•

Certificate of Waiver can only perform tests categorized as waived;*

•

Certificate for Provider Performed Microscopy Procedures (PPM) can only perform tests categorized as PPM, or _
tests categorized as PPM and waived tests;*

•

Certificate of Compliance can perform tests categorized as waived, PPM and moderate and/or high complexity
tests provided the applicable CLIA quality standards are met; and

•

Certificate of Accreditation can perform tests categorized as waived, PPM and moderate and/or high
complexity non-waived tests provided the laboratory is currently accredited by an approved accreditation
organization.

*A current list of waived and PPMP tests may be obtained from your State agency. Specific test system
categorizations can also be found on the Internet at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/clia.cfm.

III. TYPE OF LABORATORY

Select your certificate type based on the highest level of test complexity performed by your laboratory.
Laboratories performing non-waived tests can choose COA or COC based on the agency you wish to survey
your laboratory.
A shared laboratory is when two or more sole practicing physicians collectively pool resources to fund a
laboratory’s operations. The definition of a shared laboratory may also include two or more physician group
practices that share the expenses for the laboratory’s operation.

IV. HOURS OF ROUTINE OPERATION

Provide only the times when actual laboratory testing is performed in your facility. Please use the HH:MM format.

V. 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. Hospice and HHA could qualify for an exception i.e. 493.35(b)(1-3),
493.43(b)(1-3) and 493.55(b)(1-3).

VI. WAIVED TESTING

Indicate the estimated total annual test volume for all waived tests performed. List can be found at:
http:www.cms.gov/CLIA/downloads/waivetbl.pdf

VII. PPM TESTING

Indicate the estimated annual test volume for all PPM tests performed. List can be found at:
http://www.cms.gov/clia/downloads/ppmp.list.pdf

VIII. NON-WAIVED TESTING (Including PPM)

The total volume in this section includes all non-waived testing, including PPM tests previously counted in section
VII. Follow the specific instructions on page 3 of the Form CMS-116 when completing this section. (Note: The
Accrediting Organization column should reflect accreditation information for CLIA purposes only; e.g., CAP, etc.).

IX. TYPE OF CONTROL

Select the type of control which most appropriately describes your facility.

X. DIRECTOR OF ADDITIONAL LABORATORIES

List all other facilities for which the director is responsible and that are under different certificate.
Note that for a Certificate of PPM, Certificate of Compliance or Certificate of Accreditation, an individual can only
serve as the director for no more than five certificates.

Once the completed Form CMS-116 has been returned to the applicable State agency and it is processed, a fee remittance coupon
will be issued. The fee remittance coupon will indicate your CLIA identification number and the amount due for the certificate, and if
applicable the compliance (survey) or validation fee. If you are applying for a Certificate of Compliance or Certificate of Accreditation,
you will initially pay for and receive a Registration Certificate. A Registration Certificate 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 verification of accreditation by an approved accreditation organization is received by CMS.
If you need additional information concerning CLIA, or if you have questions about completion of this form, please contact your
State agency.
Form CMS-116 (10/10)

Instructions

VIIi. non-waived testing

TESTS COMMONLY PERFORMED AND THEIR CORRESPONDING
LABORATORY SPECIALTIES/SUBSPECIALITIES
HISTOCOMPATIBILITY
HLA Typing (disease associated antigens)
Microbiology
Bacteriology
Gram Stain
Culture
Susceptibility
Strep screen
Antigen assays (H.pylori, Chlamydia, etc.)
Mycobacteriology
Acid Fast Smear
Mycobacterial culture
Mycobacterial susceptibility
Mycology
Fungal Culture
DTM
KOH Preps
Parasitology
Direct Preps
Ova and Parasite Preps
Wet Preps
Virology
RSV (Not including waived kits)
HPV assay
Cell culture
Diagnostic immunology
Syphilis Serology
RPR
FTA, MHATP
General Immunology
Allergen testing
ANA
Antistreptolysin O
Antigen/Antibody (hepatitis, herpes, rubella, etc.)
Complement (C3, C4)
Immunoglobulin
HIV
Mononucleosis assay
Rheumatoid factor
Tumor marker (AFP, CA 19-9, CA 15-3, CA 125)*

HEMATOLOGY
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
Rh(D) type
Antibody screening
Antibody identification
Compatibility testing
PATHOLOGY
Dermatopathology
Oral Pathology
PAP smear interpretations
Other Cytology tests
Histopathology
RADIOBIOASSAY
Red cell volume
Schilling test
Clinical CYTOGENETICS
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 (10/10)

Instructions

CHEMISTRY
Routine Chemistry
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
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**
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 VI. WAIVED TESTING

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

Note: This is not a complete list of tests covered by CLIA. Other non-waived tests and their specialties/
subspecialties can be found at http://www.cms.gov/CLIA/downloads/subject.to.CLIA.pdf and
http://www.cms.gov/CLIA/downloads/IcCodes.pdf. You may also call your State agency for further information.
State agency contact information can be found at: http://www.cms.gov/CLIA/downloads/CLIA.SA.pdf.

Form CMS-116 (10/10)

Instructions

GUIDELINES FOR COUNTING TESTS FOR CLIA
•

For histocompatibility, each HLA typing (including disease associated antigens), HLA antibody screen, or HLA
crossmatch 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 specimen regardless of the extent of
identification, number of organisms isolated and number of tests/procedures required for identification.

•

For general immunology, testing for allergens should be counted as one test per individual allergen.

•

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 immunohematology, each ABO, Rh, antibody screen, crossmatch or antibody identification is counted as
one test.

•

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 cytology, each slide (not case) is counted as one test for both Pap smears and nongynecologic cytology.

•

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.

•

For chemistry, each analyte in a profile counts as one test.

•

For urinalysis, microscopic and macroscopia 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/subspecialities, do not count calculations (e.g., A/G ratior, 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.

Form CMS-116 (10/10)

Instructions