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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved CENTERS FOR MEDICARE & MEDICAID SERVICES OMB No.  0938­0581

CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) APPLICATION FOR CERTIFICATION

(FORM CMS-116)

I. GENERALINFORMATION

❏ Initial Application ❏ Survey	CLIA Number
❏ Change in Certificate Type ❏ Other Changes	__________D___________________ (If an initial application leave blank, a number will be assigned)
Facility Name	Federal Tax Identification Number
	Telephone No. (Include area code) Fax No. (Include area code)
Facility Address — Physical Location of Laboratory	Mailing Address (If different from street address, include
(Building, Floor, Suite if applicable.) Fee Coupon/Certificate will be mailed to this Address unless mailing address is specified)	attention line and/or Building, Floor, Suite)
Number, Street (No P.O. Boxes)	Number, Street
City State ZIP Code	City State ZIP Code
Name of Director (Last, First, Middle Initial)	For Office Use Only Date Received ___________

II. TYPE OF CERTIFICATE REQUESTED (Check 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 through 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.

0. ❏ JCAHO ❏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 for CLIA purposes or evidence of application for such accreditation within 11 months after receipt of your Certificate of Registration. 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 0938­0581. 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. 

III. TYPE OF LABORATORY (Check the one most descriptive of facility type)

• ❏01 Ambulance ❏10 Health Fair ❏21 Physician Office

• ❏02 Ambulatory Surgery Center ❏11 Health Main. Organization ❏22 Practitioner Other (Specify)

• ❏03 Ancillary Testing Site ❏12 Home Health Agency _____________________

• in Health Care Facility ❏13 Hospice ❏23 Prison

• ❏04 Assisted Living Facility ❏14 Hospital ❏24 Public Health Laboratories  

  0. ❏05 Blood Bank ❏15 Independent ❏25 Rural Health Clinic

  1. ❏06 Community Clinic ❏16 Industrial ❏26 School/Student Health Service

  2. ❏07 Comp. Outpatient Rehab Facility ❏17 Insurance ❏27 Skilled Nursing Facility/Nursing

  3. ❏08 End Stage Renal Disease ❏18 Intermediate Care Facility Facility
     Dialysis Facility for Mentally Retarded ❏28 Tissue Bank/Repositories

  4. ❏09 Federally Qualified ❏19 Mobile Laboratory ❏29 Other (Specify)

  5. Health Center ❏20 Pharmacy _____________________

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:

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 the 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 not­for­profit 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 Number
Name of Laboratory or Hospital Department
Address/Location (Number, Street, Location if applicable)

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

VI. WAIVED TESTING

Indicate the estimated TOTAL ANNUAL TEST volume for all waived tests performed _____________

❏ Check if no waived tests are performed.

VII. PPM TESTING

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

VIII. NONWAIVED 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 () 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 certificate of accreditation, indicate the name of the accreditation organization beside the applicable specialty/subspecialty for which you are accredited for CLIA compliance. (JCAHO, AOA, AABB, CAP, COLA or ASHI)

SPECIALTY /	ACCREDITING	ANNUAL	SPECIALTY /	ACCREDITING	ANNUAL
SUBSPECIALTY	ORGANIZATION	TEST VOLUME	SUBSPECIALTY	ORGANIZATION	TEST VOLUME
HISTOCOMPATIBILITY ❏ Transplant			HEMATOLOGY ❏ Hematology
❏ Nontransplant
			IMMUNOHEMATOLOGY
MICROBIOLOGY			❏ ABO Group
❏ Bacteriology			& Rh Group
❏ Mycobacteriology			❏ Antibody Detection
❏ Mycology			(transfusion)
❏ Parasitology ❏ Virology			❏ Antibody Detection (nontransfusion) ❏ Antibody Identification
DIAGNOSTIC			❏ Compatibility Testing
IMMUNOLOGY
❏ Syphilis Serology			PATHOLOGY
❏ General Immunology			❏ Histopathology
			❏ Oral Pathology
CHEMISTRY			❏ Cytology
❏ Routine
❏ Urinalysis			RADIOBIOASSAY
❏ Endocrinology			❏ Radiobioassay
❏ Toxicology
			CLINICAL
			CYTOGENETICS
			❏ Clinical Cytogenetics

TOTAL ESTIMATED ANNUAL TEST VOLUME___________

(including PPM tests)

VOLUNTARY NONPROFIT FOR PROFIT GOVERNMENT

❏01 Religious Affiliation     ❏04 Proprietary ❏05 City ❏08 Federal

❏02 Private ❏06 County ❏09 Other Government

❏03 Other ____________ ❏07 State ____________________

(Specify) (Specify)

         

X. DIRECTOR OF ADDITIONAL 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

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) DATE

THE CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) APPLICATION 
(FORM CMS-­116)

I NSTRUCTIONS 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.

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 or CMS regional office for processing.

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 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 reviewed via the Internet on http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/clia.cfm.

**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.

III. TYPE OF LABORATORY

Select the type of laboratory designation that is most appropriate for your facility from the list provided. If you cannot find your designation within the list, contact your State agency for assistance. 

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.

VI. WAIVED TESTING

Indicate the estimated total annual tests volume for all waived tests performed. 

VII. PPM TESTING

Indicate the estimated annual test volume for all PPM tests performed.

VIII. NON­WAIVED 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., JCAHO, etc.).

IX. TYPE OF CONTROL

Select the type which most appropriately describes your facility. 

X. DIRECTOR OF ADDITIONAL LABORATORIES

List all other facilities for which the director is responsible.

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 coupon will be issued. The fee coupon will indicate your CLIA 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. A registration certificate permits a facility applying for a Certificate of Accreditation, to perform testing until CMS received verification of accreditation by an accreditation organization.

If you need additional information concerning CLIA, or if you have questions about completion of this form, please c ontact your State agency.

TESTS COMMONLY PERFORMED AND THEIR CORRESPONDING LABORATORY SPECIALTIES/SUBSPECIALTIES

H ISTOCOMPATABILITY BACTERIOLOGY

HLA Typing (disease associated antigens) Gram Stains

Cultures

SYPHILIS SEROLOGY Sensitivities

RPR Strep Screens

FTA, MHA­TP Antigen assays (chlamydia, etc.)

H. pylori

GENERAL IMMUNOLOGY

Mononucleosis Assays MYCOBACTERIOLOGY

Rheumatoid Arthritis Acid Fast Smears

Febrile Agglutins Mycobacterial Cultures

Cold Agglutinins Sensitivities

HIV

Antibody Assays (hepatitis, herpes, etc.) MYCOLOGY

ANA Assays Fungal Cultures

Mycoplasma pneumoniae Assays DTM

KOH Preps

PARASITOLOGY

Direct Preps VIROLOGY

Ova and Parasite Preps RSV

Wet Preps HPV assays

Cell cultures

CHEMISTRY

Routine Chemistry Endocrinology

Albumin ALT/SGPT TSH

Ammonia AST/SGOT Free T4

Alk Phos Amylase Total T4

Bilirubin, Total BUN Triiodothyronine (T3)

Bilirubin, direct CPK/CPK isoenzymes T3 Uptake

Calcium CKMB Serum­-beta-­HCG

Chloride Cholesterol, total

CO2, total Creatinine Toxicology

Ferritin Folate Acetaminophen Procainamide

Glucose HDL Cholesterol Blood alcohol NAPA

Iron LDH Carbamazephine Quinidine

Magnesium LDH isoenzymes Digoxin Salicylates

pH Phosphorous Ethosuximide Theophylline

pO2 Potassium Gentamycin Tobramycin

pCO2 Protein, total Lithium Valproic acid

PSA SGGT Phenobarbitol

Sodium Triglycerides Phenytoin

Vitamin B12 Uric acid Primidine

Urinalysis

Automated urinalysis

Urinalysis with microscopic analysis

Urine specific gravity by refractometer

Urine specific gravity by urinometer

Urine protein by sulfasalicylic acid

HEMATOLOGY IMMUNOHEMATOLOGY

WBC count ABO group

RBC count Rh(D) type

Hemoglobin Antibody Screening

Hematocrit (Other than spun micro) Antibody Identification

Platelet Compatability testing

Differential

MCV PATHOLOGY

Activated Clotting Time Dermatopathology

Prothrombin time Oral pathology

Partial thromboplastin time PAP smear interpretations

Fibrinogen Other cytology tests

Reticulocyte count Histopathology

Manual WBC by hemocytometer

Manual platelet by hemocytometer CYTOGENETICS

Manual RBC by hemocytometer Fragile X

Sperm count Buccal smear

RADIOBIOASSAY

Red cell volume

Schilling’s test

G UIDELINES 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.

• Testing for allergens should be counted as one test per individual allergen.

• For chemistry profiles, each individual analyte is counted separately.

• 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 complete blood counts, each measured individual analyte that is ordered and reported is counted separately. Differentials are counted as one test.

• Do not count calculations (e. g., A/G ratio, MCH, and T7), quality control, quality assurance and proficiency testing 

assays).

• 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 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 flow cytometry each measured individual analyte that is ordered and reported is counted separately.