Blank Clia Application Cms 116 Template

The CLIA Application CMS 116 Form is a crucial document required for laboratories seeking certification under the Clinical Laboratory Improvement Amendments (CLIA). This form collects essential information about the laboratory, its ownership type, and the specific types of tests it performs. Completing this form accurately ensures compliance and enables labs to operate legally and effectively.

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Article Guide

Understanding the CMS 116 form is vital for clinical laboratories seeking certification under the Clinical Laboratory Improvement Amendments (CLIA). This form serves multiple purposes, including applications for initial certification, changes in certificate type, and modifications related to the laboratory's specifics. At its core, it collects essential information about the laboratory, such as its identification number, federal tax ID, and facility name. The form also requests details regarding the type of certificate being applied for—ranging from a Certificate of Waiver to a Certificate of Compliance or Accreditation. Each type of certificate carries different requirements, and the CMS 116 helps streamline this process. Laboratories must indicate their operation hours, testing types, and the estimated annual test volume, ensuring compliance with government regulations. Additionally, the form includes questions about the laboratory's ownership and interactions with other certified laboratories. By filling out this form accurately, laboratories can secure their certifications, which are crucial for maintaining standards of care and ensuring public health safety.

Form Sample

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

CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA)

APPLICATION FOR CERTIFICATION

ALL APPLICABLE SECTIONS OF THIS FORM MUST BE COMPLETED.

I. GENERAL INFORMATION

Initial Application

Anticipated Start Date

CLIA IDENTIFICATION NUMBER

Survey

Change in Certificate Type

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

Other Changes (Specify)

Effective Date

FACILITY NAME

FEDERAL TAX IDENTIFICATION NUMBER

EMAIL ADDRESS

TELEPHONE NO. (Include area code)

FAX NO. (Include area code)

RECEIVE FUTURE NOTIFICATIONS VIA EMAIL

FACILITY ADDRESS — Physical Location of Laboratory (Building, Floor, Suite if

MAILING/BILLING ADDRESS (If different from facility address) send Fee Coupon

applicable.) Fee Coupon/Certificate will be mailed to this Address unless mailing

or certificate

or corporate address is specified

NUMBER, STREET (No P.O. Boxes)

NUMBER, STREET

CITY

STATE

ZIP CODE

CITY

STATE

ZIP CODE

SEND FEE COUPON TO THIS ADDRESS

SEND CERTIFICATE TO THIS ADDRESS

CORPORATE ADDRESS (If different

NUMBER, STREET

PICK ONE:

from facility) send Fee Coupon or

certificate

Physical

Mailing

CITY

STATE

ZIP CODE

Corporate

NAME OF DIRECTOR (Last, First, Middle Initial)

Laboratory Director’s Phone Number

CREDENTIALS

FOR OFFICE USE ONLY

Date Received

II.TYPE OF CERTIFICATE REQUESTED (Check only one) Please refer to the accompanying instructions for inspection and certificate testing requirements)

Certificate of Waiver (Complete Sections I – VI and IX – X)

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 these qualifications for the laboratory director must be submitted with this application.

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.

The Joint Commission

CAP

AAHHS/HFAP

COLA

AABB

ASHI

A2LA

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.

PRA Disclosure Statement

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. Expiration Date: 03/31/2024. The time required to complete this information collection is estimated to average one hour 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 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, claims, payments, medical records or any documents containing sensitive information to the PRA Reports Clearance Office. Please note that any correspondence not pertaining to the information collection burden approved under the associated OMB control number listed on this form will not be reviewed, forwarded, or retained. If you have questions or concerns regarding where to submit your documents, please contact [email protected].

Form CMS-116 (04/20)

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

01 Ambulance

02Ambulatory Surgery Center

03Ancillary Testing Site in Health Care Facility

04Assisted Living Facility

05Blood Bank

06Community Clinic

07Comp. Outpatient Rehab Facility

08End Stage Renal Disease Dialysis Facility

09Federally Qualified Health Center

10Health Fair

11Health Main. Organization

12Home Health Agency

13Hospice

14Hospital

15Independent

16Industrial

17Insurance

18Intermediate Care Facilities for Individuals with Intellectual Disabilities

19Mobile Laboratory

20Pharmacy

21Physician Office

22Practitioner Other (Specify)

23Prison

24Public Health Laboratories

25Rural Health Clinic

26School/Student Health Service

27Skilled Nursing Facility/ Nursing Facility

28Tissue Bank/Repositories

29Other (Specify)

IV. HOURS OF LABORATORY TESTING (List times during which laboratory testing is performed in HH:MM format) If testing 24/7 Check Here

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 in 1-3 below)

Are you applying for a single site CLIA certificate to cover multiple testing locations?

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 is not at a fixed location, that is, a laboratory that moves from testing site to testing site, such as 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?

Yes

If yes and a mobile unit is providing the laboratory testing, record the vehicle identification number(s) (VINs) and attach to the application.

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

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

If yes, provide the number of sites under this certificateand 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		TELEPHONE NO. (Include area code)

Form CMS-116 (04/20)

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

VI. 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 below. Include each analyte, test system, or device used in the laboratory.

ANALYTE / TEST	TEST NAME	MANUFACTURER
Example: Streptococcus group A	Ace Rapid Strep Test	Acme Corporation

Indicate the ESTIMATED TOTAL ANNUAL TEST volume for all waived tests performed ________________

Check if no waived tests are performed

If additional space is needed, check here

and attach additional information using the same format.

VII. PPM TESTING If only applying for a Certificate for PPM, complete this section and skip section VIII (Non-Waived Testing).

Listed below are the only PPM tests that can be performed by a facility having a Certificate for PPM. Mark the checkbox by each PPM procedure(s) to 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 VI. For laboratories applying for certificate of compliance or certificate of accreditation, also include PPM test volume in the specialty/subspecialty category and the “total estimated annual 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.

Form CMS-116 (04/20)

VIII. 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 below. 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.

ANALYTE / TEST	TEST NAME	MANUFACTURER	M or H
Example: Potassium	Quick Potassium Test	Acme Lab Corporation	M

If additional space is needed, check here

and attach additional information using the same format.

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.

If additional space is needed, check here and attach additional information using the same format.” Include text box similar to Section VII.

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 instructions 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, AAHHS/HFAP, AABB, A2LA ,CAP, COLA or ASHI)

SPECIALTY /	ACCREDITING	ANNUAL	SPECIALTY /	ACCREDITING	ANNUAL
SPECIALTY /	ACCREDITING	ANNUAL	SPECIALTY /	ACCREDITING	TEST
SUBSPECIALTY	ORGANIZATION TEST VOLUME		SUBSPECIALTY	ORGANIZATION	TEST
SUBSPECIALTY	ORGANIZATION TEST VOLUME		SUBSPECIALTY	ORGANIZATION	VOLUME
					VOLUME
HISTOCOMPATIBILITY 010			HEMATOLOGY 400
Transplant			Hematology
Nontransplant			IMMUNOHEMATOLOGY
MICROBIOLOGY			ABO Group & Rh Group 510
Bacteriology 110			Antibody Detection (transfusion) 520
Mycobacteriology 115			Antibody Detection (nontransfusion) 530
Mycology 120			Antibody Identification 540
Parasitology 130			Compatibility Testing 550
Virology 140			PATHOLOGY
DIAGNOSTIC IMMUNOLOGY			Histopathology 610
Syphilis Serology 210			Oral Pathology 620
General Immunology 220			Cytology 630
CHEMISTRY			RADIOBIOASSAY 800
Routine 310			Radiobioassay
Urinalysis 320			CLINICAL CYTOGENETICS 900
Endocrinology 330			Clinical Cytogenetics
Toxicology 340			TOTAL ESTIMATED ANNUAL TEST VOLUME:
Form CMS-116 (04/20)					4

IX. TYPE OF CONTROL (CHECK THE ONE MOST DESCRIPTIVE OF OWNERSHIP TYPE)

VOLUNTARY NONPROFIT

01 Religious Affiliation

02 Private Nonprofit

03 Other Nonprofit

(Specify)

FOR PROFIT

04 Proprietary

GOVERNMENT

05 City

06 County

07 State

08 Federal

09 Other Government

(If 09 is selected, please specify the country

or the province.)

Does this facility have partial or full ownership by a foreign entity or foreign government? Yes No

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

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.

PRINT NAME OF DIRECTOR OF LABORATORY

PRINT NAME OF OWNER OF LABORATORY

SIGNATURE OF OWNER/DIRECTOR OF LABORATORY (SIGN IN INK OR USE A SECURE ELECTRONIC SIGNATURE)

DATE

NOTE: Completed 116 applications must be sent to your local State Agency. Do not send any payment with your completed 116 application.

STATE AGENCY CONTACT INFORMATION CAN BE FOUND AT: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA.pdf

Form CMS-116 (04/20)

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. 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. 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 (42 CFR PART 493) 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” 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: 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.

Email Address: A valid Email Address is optional and will be used for communications between the CLIA program and the laboratory. Selecting the RECEIVE NOTIFICATIONS VIA EMAIL checkbox, requires the laboratory to enter a valid Email Address.

Physical Facility Address: This 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.

If the laboratory has a separate mailing and/or corporate address (from the Facility Address), please complete the appropriate sections on the form.

Mailing Address: This 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, such as an accounts payable office. A Post Office box number or Mail Stop number may be used as part of the Mailing Address for this section.

Corporate Address: This 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. A Post Office box number or Mail Stop number may be used as part of the Corporate Address for this section.

Form Mailing: Select the address (Physical, Mailing, Corporate) where the CLIA fee coupon and CLIA certificate are to be mailed.

For Office Use Only: The date received is the date the form is received by the state agency or CMS regional office for processing.

II. TYPE OF CERTIFICATE REQUESTED

Select your certificate type based on the highest level of test complexity performed by your laboratory. A laboratory performing non-waived tests can choose Certificate of Compliance or Certificate of Accreditation based on the agency you wish to survey your laboratory.

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

Form CMS-116 (04/20)

Instructions

•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 following a CLIA survey; 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. (If your CMS-approved accreditation organization is not listed, contact your local State Agency for further instructions.)

*A current list of waived and PPM 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 the type that is most descriptive of the location where the laboratory testing is performed.

If selecting ‘mobile laboratory’ (code 19), a mobile laboratory is defined as a movable, self-contained operational laboratory with its own personnel, equipment, and records. For record keeping purposes, include, on a separate sheet of paper, the vehicle identification numbers (VINs) of all vehicles used for mobile laboratory testing.

If selecting ‘Practitioner Other’ (code 22), this type includes practitioners such as, dentists, chiropractors, etc.

IV. HOURS OF ROUTINE OPERATION

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.

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

VI. WAIVED TESTING

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

VII. PPM TESTING

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

VIII. NON-WAIVED TESTING (INCLUDING PPM)

The total Estimated Annual Test 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 for test counting information. (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 ownership or 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 certificates. 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.

Reminders - Before submitting the Form CMS-116:

1.Include the current or estimated annual test volume.

2.For Certificate for PPM, Certificate of Compliance, or Certificate of Accreditation, include the laboratory director qualifications.

3.Do not send any money with your application.

4.Send the completed Form CMS-116 to the appropriate State Agency (https://www.cms.gov/Regulations-and-Guidance/ Legislation/CLIA/Downloads/CLIASA.pdf).

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. State agency contact information can be found at: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA.pdf

Form CMS-116 (04/20)

Instructions

VIII. NON-WAIVED TESTING

TESTS COMMONLY PERFORMED AND THEIR CORRESPONDING

LABORATORY SPECIALTIES/SUBSPECIALITIES

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

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)*

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

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.

Form CMS-116 (04/20)

Instructions

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

Endocrinology (330)

Cortisol

HCG (serum pregnancy test) T3

T3 Uptake

T4, free

TSH

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 VI. WAIVED TESTING

NOTE: This is not a complete list of tests covered by CLIA. Other non-waived tests and their specialties/ subspecialties can be found at https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/SubjecttoCLIA.pdf and https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/lccodes.pdf. You may also call your State agency for further information. State agency contact information can be found at: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA.pdf.

Form CMS-116 (04/20)

Instructions

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 tests should be placed in the specialty or subspecialty where they fit best, according to the methodology of the test.

•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 cross match 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/subspecialities, 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.

Form CMS-116 (04/20)

Instructions

⇩ PDF

Document Specifications

Fact	Description
Form Purpose	The CMS 116 form is used to apply for certification under the Clinical Laboratory Improvement Amendments (CLIA) to ensure labs meet federal standards.
OMB Control Number	This form has an OMB control number of 0938-0581, which is necessary for tracking and compliance purposes.
Application Sections	Completing all applicable sections of the form is mandatory to avoid delays in processing the application.
Types of Certificates	The form allows for several types of certificates, including Certificate of Waiver, Certificate for Provider-Performed Microscopy Procedures (PPM), Certificate of Compliance, and Certificate of Accreditation.
Director Qualifications	Laboratory directors performing non-waived testing must meet specific education and experience qualifications as outlined in CLIA regulations.
Submission Guidelines	Completed forms must be sent to local state agencies without payment, as specified in the instructions included with the application.
Expiration Date	The expiration date for the currently approved version of the form is March 31, 2024, after which a new submission may be necessary.

Steps to Filling Out Clia Application Cms 116

Completing the CLIA Application CMS 116 form is essential for laboratories seeking certification under the Clinical Laboratory Improvement Amendments. Once filled out accurately, this form will be submitted to the relevant state agency for processing. It’s important to gather all necessary information before beginning the application to ensure a smooth completion process.

Obtain the Form: Download the CLIA Application CMS 116 form from the official website or your local state agency.
Fill in General Information: Start by entering your facility name, address, and contact details. Include the anticipated start date and check the box for the type of application (initial or change).
Indicate Certificate Type: Select the type of certificate you are requesting (e.g., Certificate of Waiver, Certificate of Compliance, etc.). Make sure to complete the relevant sections based on your choice.
Select Type of Laboratory: Check the box that best describes your laboratory’s type (e.g., hospital, independent lab, etc.).
Input Laboratory Testing Hours: Provide the hours during which your laboratory operates. Use the HH:MM format and indicate if testing occurs 24/7.
Multiple Sites: If applicable, confirm if you’re applying for a certificate for multiple sites and complete the corresponding information as required.
Complete Testing Sections: Fill out sections detailing the tests performed, including Waived Testing, PPM Testing, and Non-Waived Testing, if applicable. Be as specific as possible about analytes, test names, and annual test volumes.
Ownership Type: Check the most descriptive option regarding the ownership of your laboratory.
Director Affiliations: If the laboratory director oversees other certified laboratories, complete this part by listing the CLIA numbers and names of those laboratories.
Review and Sign: Carefully review the entire application for accuracy. Both the laboratory owner and the director need to print their names, sign, and date the application.
Submit: Send the completed application to your local state agency. Payment is not required at this stage.

More About Clia Application Cms 116

What is the purpose of the CLIA Application CMS 116 form?

The CLIA Application CMS 116 form is primarily designed for laboratories seeking certification under the Clinical Laboratory Improvement Amendments (CLIA). This certification ensures that laboratories meet federal standards for quality laboratory testing. By completing this form, facilities provide necessary information for their initial application, changes in certificate types, or other modifications to their certification status.

Who needs to fill out this form?

This form must be completed by any laboratory that is applying for CLIA certification, whether it’s an initial application or for a change in an existing certificate. This includes various types of facilities, such as hospitals, independent labs, and mobile testing units, all of which must adhere to CLIA regulations to ensure they meet the required standards for laboratory testing.

What information must be provided on the form?

The form requires general information about the facility, including its name, address, type, and federal tax identification number. Additionally, details concerning the types of tests performed, the certificate being requested (such as Certificate of Waiver or Certificate of Accreditation), operational hours, and ownership type must be included. This detailed information allows the Centers for Medicare & Medicaid Services (CMS) to assess the laboratory’s eligibility for certification.

What types of certificates can be requested through this application?

There are several types of certificates that laboratories can request via the CMS 116 form. These include: Certificate of Waiver, Certificate for Provider Performed Microscopy Procedures (PPM), Certificate of Compliance, and Certificate of Accreditation. Each type has specific requirements concerning testing complexity and must be accompanied by the appropriate documentation to demonstrate compliance with CLIA regulations.

How long does it typically take to complete this form?

Completing the CLIA Application CMS 116 form is estimated to take about one hour. This timeframe includes reading the instructions, gathering necessary data, and completing the form itself. It is vital to ensure that every section is accurately filled out to prevent delays in processing the application.

What happens after the application is submitted?

After submission, the relevant state agency will review the application. If everything is in order, they will process the application and issue the appropriate certification. Depending on the volume of applications and the completeness of the submitted data, this process may vary in duration.

Can a lab apply for a single CLIA certificate to cover multiple testing locations?

Yes, laboratories can apply for a single CLIA certificate for multiple sites, but they must meet certain regulatory exceptions. For instance, if the sites are all part of a contiguous space under common direction, or if the laboratory operates on a mobile basis, this can simplify the process of obtaining a single certificate.

Who should be contacted for questions regarding the application?

If there are any questions or concerns about the application process, it is advisable to contact [email protected]. This email ensures that inquiries reach the appropriate department for timely assistance.

Common mistakes

Incomplete Information: Many applicants neglect to fill out all required sections of the CLIA Application CMS 116. Missing key information, such as the facility name, federal tax identification number, or director’s credentials, can lead to delays or outright rejection of the application.
Incorrect Certificate Selection: Selecting the wrong type of certificate is a common mistake. Applicants sometimes check more than one option, or fail to understand the requirements for each certificate type, leading them to apply for a certificate that does not align with their laboratory capabilities.
Failure to Provide Required Documentation: When applying for certain certificates, such as the Certificate of Accreditation, it is critical to attach proof of accreditation or application. Applicants frequently overlook this step, which is necessary to demonstrate compliance with CLIA regulations.
Omitting Estimated Test Volumes: Applicants often forget to indicate estimated annual test volumes for waived, PPM, and non-waived testing. This information is essential for determining the laboratory's needs and ensuring proper assessment by regulatory agencies.

Documents used along the form

When submitting the CLIA Application (CMS 116 form), several additional forms and documents may be required depending on the laboratory's specific circumstances. These documents help ensure compliance with federal regulations and facilitate the certification process.

CLIA Survey Application (CMS-1676 Form): This form is often submitted to request a survey by state or local health authorities. It ensures that the laboratory meets all applicable requirements before certification.
Laboratory Director's Qualifications: Documentation verifying the education, training, and experience of the laboratory director is essential, especially when applying for non-waived testing certificates.
Accreditation Certificate: If the laboratory applies for a Certificate of Accreditation, it must submit proof of accreditation from an approved organization, demonstrating it meets specific performance standards.
Fee Coupon: This document accompanies the application to indicate the laboratory’s payment method for fees associated with certification. It is crucial for processing the application.
Test Menu Documentation: A detailed list of tests offered by the laboratory, including the complexity of each test, is needed for classification and compliance purposes.
Quality Assurance Plan: A comprehensive quality assurance document outlining protocols for testing accuracy, reliability, and compliance with CLIA standards may be requested.
Multiple Locations Information: If applicable, this document outlines details about any additional testing sites the laboratory wishes to cover under a single CLIA certificate.
Annual Volume Estimate: A summary that estimates the expected annual test volume for all tests performed by the laboratory, as required for certain types of certificates.
Laboratory Policies and Procedures: Written policies and standard operating procedures that detail the laboratory’s testing processes, safety measures, and regulatory compliance can be required for review.
Clinical Laboratory Improvement Amendments (CLIA) Compliance Statement: An affirmation that the laboratory adheres to CLIA regulations, which can bolster the application’s credibility.

These documents play a vital role in facilitating the review and approval of the CLIA Application. By preparing these forms correctly, laboratories can ensure a smoother certification process and compliance with necessary regulations.

Similar forms

The CLIA Application CMS 116 form shares similarities with the Medicare Enrollment Application, Form CMS-855A. Both documents require detailed information about healthcare providers and facilities, helping federal and state agencies evaluate eligibility for participation in Medicare. Just as the CMS 116 form collects information about laboratory services and director qualifications, the CMS-855A gathers data related to medical professionals, including their specialties and locations. Both forms ensure compliance with regulations that safeguard health standards, ultimately aiming to maintain a high level of patient care across different types of healthcare facilities.

Another document akin to the CLIA Application is the Laboratory Accreditation Application. This application is essential for laboratories seeking accreditation from recognized organizations, similarly to how the CMS 116 form facilitates the certification process under CLIA. Both applications outline specific criteria and required documentation, such as proof of qualifications for laboratory directors. By adhering to standards laid out in these forms, laboratories demonstrate their commitment to quality and compliance, essential aspects for maintaining accreditation or certification.

The Clinical Laboratory Privacy Data Form also mirrors the CMS 116 form in its purpose of collecting vital information regarding laboratory operations. This form focuses on patient privacy and data protection measures in place at the laboratory. While the CMS 116 form centers around the laboratory's operational details and compliance with health regulations, both documents highlight the importance of maintaining integrity and transparency in managing sensitive health information, reflecting a shared commitment to patient care and ethical clinical practices.

Similar to the CLIA Application is the State Licensing Application for Laboratories, which is required in many states for laboratories operating within their jurisdictions. This application gathers similar information regarding facility operations, ownership, and testing capabilities. Just as the CMS 116 form establishes a laboratory's compliance with federal laws, state licensing applications ensure that local regulations are met, promoting high-quality laboratory services and protecting public health at the state level.

The Certificate of Need application also has parallels with the CMS 116 form as it involves the procedural requirements for starting or expanding healthcare facilities. Both documents require prospective providers to present information about their services, management, and operational plans. The approval processes for both forms ensure that healthcare services, including laboratory operations, meet community needs and government standards, facilitating the delivery of essential services while preventing unnecessary duplication in the healthcare system.

The Provider Enrollment Application for Durable Medical Equipment (DME) suppliers shares traits with the CLIA Application, focusing on the necessary documentation and information required for compliance with healthcare regulations. Both forms ascertain eligibility to provide specific healthcare services and gather details on operational standards. By ensuring that DME suppliers or laboratories meet the necessary requirements, these applications help protect patients and support efficient healthcare delivery across various sectors.

Lastly, the Application for the National Provider Identifier (NPI) is another document connected to the CLIA Application CMS 116 form. Both applications function as tools for identifying healthcare entities and their compliance with regulations. The NPI application assigns a unique identifier to healthcare providers and organizations, similar to how the CMS 116 application collects necessary information about the laboratory's operations and qualifications. By facilitating a standardized identification process, these documents aim to enhance the efficiency of healthcare systems while ensuring adherence to established standards and practices.

Dos and Don'ts

When filling out the CLIA Application CMS 116 form, it’s important to follow certain guidelines to ensure a smooth application process. Here are four do’s and don’ts to consider:

Do complete all applicable sections of the form. Leaving sections blank can lead to delays in processing your application.
Do ensure all information is accurate and up-to-date. This includes your facility name, address, and contact information. Inaccuracies can cause complications later.
Do check the specific requirements for the type of certificate you are applying for. Different types of certificates require different sections of the form to be completed.
Do submit supporting documentation when required. For example, if you are applying for a Certificate of Accreditation, you must provide evidence of your accreditation.

Don’t use a P.O. Box for the facility address. The application requires a physical location of the laboratory.
Don’t forget to sign and date the application. An unsigned application will not be processed.
Don’t send the application to the PRA Reports Clearance Office. Submit the completed form to your local State Agency instead.
Don’t include any payment with your application. Payments should be handled separately as instructed.

Misconceptions

Understanding the CLIA Application Form CMS 116 can be challenging due to some prevalent misconceptions. Here are six common misunderstandings clarified for better comprehension.

Misconception 1: All laboratories need to fill out the entire form.

This is not true. The form has different sections, and only the relevant sections need to be completed based on the type of certificate requested and the specifics of the laboratory.

Misconception 2: Only large laboratories must apply for certification.

Every laboratory, regardless of size—even those in private practices or small clinics—must apply for certification if they perform testing on human specimens. Certification applies to a wide variety of laboratory types.

Misconception 3: There’s no need to provide documentation for the laboratory director’s qualifications.

In fact, for laboratories that perform non-waived testing, proof of the director’s education, training, and experience is essential. This documentation supports compliance with specific regulations.

Misconception 4: Submitting the application guarantees automatic approval.

Submitting the application is just the first step. The laboratory must also pass an inspection. Approval is contingent upon meeting the necessary standards outlined by the CLIA.

Misconception 5: The fee coupon will be sent to the facility address only.

The fee coupon can be sent to a different address, if specified. Applicants must choose where they would like to receive it, whether at the facility or corporate address.

Misconception 6: Once certified, there’s no need for further action.

This misconception overlooks the importance of active compliance. Laboratories must maintain standards continuously and are subject to periodic inspections to ensure adherence to CLIA regulations.

By addressing these misconceptions, laboratories can better prepare for completing the CMS 116 and ensure compliance with the necessary regulations. It is crucial to approach the certification process with accurate knowledge and understanding.

Key takeaways

Complete All Sections: It's essential to fill out all applicable sections of the CMS 116 form for CLIA certification. Incomplete forms may result in delays or rejection.
Anticipated Start Date: Be sure to provide your anticipated start date for laboratory operations, as this information is necessary for processing your application.
Choose the Correct Certificate Type: Determine which type of certificate best fits your laboratory’s services, whether it's for Waived Testing, Provider Performed Microscopy (PPM), Compliance, or Accreditation. Each has different requirements.
Provide Accurate Ownership Information: Indicate the ownership type of your laboratory accurately. This includes whether it is nonprofit, for-profit, or government-owned, as this affects regulatory requirements.
Testing Location Details: If your laboratory operates at multiple sites, specify the situation clearly. Understand the regulatory exceptions, such as being a mobile unit or a hospital with multiple labs on the same campus.
Testing Volume Estimates: Provide realistic estimates of annual testing volumes for all waived and non-waived tests to ensure compliance with regulatory standards.
Include Valid Credentials: For laboratories performing non-waived testing, ensure that you include proof of the laboratory director’s credentials, as this is a key requirement for certification.
Sign and Date the Application: Before submitting the form, make sure it is signed and dated by the laboratory director, as this is crucial for validating your application.
Submit to the Correct Address: Send your completed CMS 116 application to the appropriate local state agency, not to the PRA Reports Clearance Office or any other address.