➾

Fill in Your Clia Application Cms 116 Template

The CLIA Application CMS 116 form is a critical document used for certification under the Clinical Laboratory Improvement Amendments (CLIA). It requires comprehensive information about the laboratory, including its location, ownership, and types of tests performed. Completing this form accurately ensures compliance with federal regulations and facilitates the laboratory's operational approval.

Table of Contents

The CMS 116 form, an essential document for laboratories seeking certification under the Clinical Laboratory Improvement Amendments (CLIA), serves multiple purposes in the certification process. This form requires applicants to provide a range of information, including general details about the laboratory, such as its name, address, and contact information. Additionally, it allows laboratories to specify the type of certificate they are applying for, whether it be a Certificate of Waiver, a Certificate for Provider Performed Microscopy Procedures, a Certificate of Compliance, or a Certificate of Accreditation. Each type of certificate has specific requirements, and the form guides applicants through the necessary sections to ensure compliance. Furthermore, the CMS 116 includes sections for detailing the types of tests performed, estimated annual test volumes, and the laboratory's operational hours. It also addresses multiple site applications, allowing for streamlined certification across various locations under certain conditions. Completing this form accurately is crucial for laboratories to maintain compliance and ensure the quality of testing services provided to the public.

Sample - Clia Application Cms 116 Form

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

↓ Clia Application Cms 116 PDF

File Specs

Fact Name	Fact Description
Form Purpose	The CMS 116 form is used to apply for certification under the Clinical Laboratory Improvement Amendments (CLIA).
Application Types	Applicants can request various types of certificates, including a Certificate of Waiver, Certificate for Provider Performed Microscopy Procedures (PPM), Certificate of Compliance, or Certificate of Accreditation.
Required Information	All applicable sections must be completed, including general information, type of certificate requested, and details about laboratory testing.
Submission Instructions	Completed applications must be sent to the local State Agency, and no payment should accompany the application.
Governing Laws	The form is governed by the Public Health Service Act and CLIA regulations, which set standards for laboratory testing and operations.
OMB Control Number	The form has an OMB control number of 0938-0581, which is required for information collection purposes.
Expiration Date	The current expiration date for the form is March 31, 2024, after which it may need to be revised or renewed.

Clia Application Cms 116 - Usage Guidelines

Filling out the CLIA Application CMS 116 form requires careful attention to detail. Each section must be completed accurately to ensure a smooth application process. Follow these steps to fill out the form correctly.

Start with General Information. Indicate whether this is an initial application or a change in certificate type. Provide your facility name, CLIA identification number (if applicable), federal tax identification number, email address, telephone number, and fax number.
Fill in the Facility Address and the Mailing/Billing Address if different. Ensure that you include the complete street address, city, state, and zip code.
Specify the Type of Certificate Requested by checking the appropriate box. Choose from options like Certificate of Waiver, Certificate for Provider Performed Microscopy Procedures, Certificate of Compliance, or Certificate of Accreditation.
Indicate the Type of Laboratory by checking the box that best describes your facility type. Options include hospital, independent laboratory, and more.
List the Hours of Laboratory Testing. Use HH:MM format for each day of the week. If your laboratory operates 24/7, check the appropriate box.
If applying for multiple sites, answer the question about Multiple Sites. If yes, provide the necessary details and indicate which regulatory exceptions apply.
Complete the Waived Testing section if applying for a Certificate of Waiver. List the tests performed and the estimated total annual test volume.
For PPM testing, fill out the PPM Testing section. Mark the checkbox for each procedure to be performed and provide the estimated total annual test volume.
In the Non-Waived Testing section, identify all non-waived tests performed. Include details about analytes, test names, manufacturers, and estimated annual test volumes.
Check the Type of Control that describes your ownership type. Options include voluntary nonprofit, for-profit, and government.
If applicable, complete the Director Affiliation with Other Laboratories section. List any other laboratories where the director serves.
Finally, read the consent carefully, print the names of the director and owner, and sign the application. Ensure the date is included.

Once the form is filled out, submit it to your local State Agency. Do not include any payment with your application. Make sure to check the state agency contact information for submission details.

Your Questions, Answered

What is the CLIA Application CMS 116 form?

The CLIA Application CMS 116 form is a crucial document used to apply for certification under the Clinical Laboratory Improvement Amendments (CLIA). This form collects essential information about the laboratory, including its type, ownership, and the specific tests it intends to perform. Completing this form accurately is vital for laboratories seeking to operate legally and maintain compliance with federal regulations.

Who needs to fill out the CMS 116 form?

Any laboratory that wishes to receive CLIA certification must complete the CMS 116 form. This includes a wide range of facilities, such as hospitals, independent laboratories, and mobile testing units. Whether a laboratory is applying for its initial certification or making changes to its existing certification, the CMS 116 form must be filled out thoroughly and submitted to the appropriate state agency.

What types of certificates can be requested using the CMS 116 form?

The CMS 116 form allows applicants to request several types of certificates, including a Certificate of Waiver, a Certificate for Provider Performed Microscopy Procedures (PPM), a Certificate of Compliance, and a Certificate of Accreditation. Each certificate type has specific requirements and is designed for different levels of laboratory testing complexity. Applicants should carefully select the type that aligns with their laboratory's capabilities and testing procedures.

What information is required in the CMS 116 form?

Completing the CMS 116 form requires detailed information about the laboratory, including its name, address, and ownership structure. Applicants must also specify the types of tests they will perform, the estimated annual test volume, and the qualifications of the laboratory director. Additionally, if the laboratory is seeking a Certificate of Accreditation, evidence of accreditation from an approved organization must be provided.

How long does it take to complete the CMS 116 form?

According to the information provided with the CMS 116 form, it is estimated that completing the form will take approximately one hour. This time includes reviewing the instructions, gathering necessary data, and filling out the required sections. It is advisable for applicants to prepare in advance to ensure all needed information is readily available.

Where should the completed CMS 116 form be sent?

After completing the CMS 116 form, applicants must submit it to their local state agency. It is important not to send any payment with the application. Each state has its own contact information for submission, which can typically be found on the Centers for Medicare & Medicaid Services (CMS) website.

What happens after the CMS 116 form is submitted?

Once the CMS 116 form is submitted, the appropriate state agency will review the application. If everything is in order, the laboratory will receive its CLIA certificate, allowing it to operate legally. The agency may also conduct inspections to ensure compliance with CLIA regulations. Laboratories are encouraged to maintain all records and be prepared for any potential audits or inspections following certification.

Common mistakes

When completing the CLIA Application CMS 116 form, individuals often encounter challenges that can lead to mistakes. Here are four common errors to be aware of:

Incomplete Sections:
Many applicants fail to fill out all applicable sections of the form. Each section is crucial for the processing of the application. Missing information can delay certification.
Incorrect Facility Type Selection:
Choosing the wrong type of laboratory can lead to complications. The facility type must accurately reflect the nature of the laboratory to ensure compliance with specific regulations.
Missing Director Credentials:
Applicants often overlook the requirement to submit proof of the laboratory director’s qualifications. This documentation is essential for non-waived testing applications.
Improper Submission of Supporting Documents:
Some individuals fail to attach necessary documents or provide them in the wrong format. All supporting materials must be included and organized according to the application instructions.

By being aware of these common mistakes, applicants can improve their chances of a smooth application process and timely certification.

Documents used along the form

The CLIA Application CMS 116 form is an essential document for laboratories seeking certification under the Clinical Laboratory Improvement Amendments. Along with this application, several other forms and documents may be necessary to ensure compliance and facilitate the certification process. Below is a list of commonly used documents that accompany the CMS 116 form.

CLIA Fee Coupon: This document is used to submit payment for the certification application. It outlines the fees associated with the type of certificate requested and must be included with the application.
Laboratory Director's Qualifications: Proof of the laboratory director's qualifications is required, especially for non-waived testing. This document includes education, training, and experience details.
Accreditation Evidence: If applying for a Certificate of Accreditation, evidence of accreditation from an approved organization must be submitted. This document verifies that the laboratory meets specific standards.
Inspection Reports: Recent inspection reports from a recognized authority may be required. These reports provide insight into the laboratory's compliance with safety and operational standards.
Testing Procedures Documentation: This document outlines the specific testing procedures the laboratory will perform. It helps clarify the type of tests and the methods used.
Site Information Forms: If the laboratory operates multiple sites, additional forms detailing each location's information and testing performed may be necessary.
Annual Test Volume Estimates: This document includes estimates of the annual test volume for all types of testing performed. It is crucial for determining the laboratory's capacity and compliance.

Each of these documents plays a vital role in the certification process. Submitting them accurately and completely can help facilitate a smoother application experience. If you have any questions about these documents, please reach out for assistance.

Similar forms

The CLIA Application CMS 116 form is similar to the Medicare Enrollment Application (CMS-855). Both documents are used by healthcare providers to enroll in Medicare and obtain necessary certifications. The CMS-855 requires detailed information about the provider's services, ownership, and operational details, much like the CMS 116 requires information about the laboratory's operations and testing capabilities. Both forms aim to ensure compliance with federal regulations and facilitate the proper functioning of healthcare services.

Another comparable document is the State Laboratory License Application. This application is required by many states for laboratories to operate legally within their jurisdiction. Similar to the CMS 116, it collects information about the laboratory's ownership, services, and compliance with state regulations. Both documents are essential for ensuring that laboratories meet the necessary standards for patient safety and quality of care.

The Clinical Laboratory Director's Credentialing Form is also similar. This document verifies the qualifications of the laboratory director, ensuring they meet the educational and professional standards required by CLIA. Like the CMS 116, it emphasizes the importance of qualified leadership in maintaining laboratory compliance and quality of testing.

The Laboratory Compliance Self-Assessment Tool shares similarities as well. This tool helps laboratories evaluate their adherence to CLIA standards and identify areas needing improvement. Both the self-assessment and the CMS 116 form focus on compliance and operational excellence, aiming to enhance laboratory performance and patient safety.

The Laboratory Accreditation Application is another related document. Laboratories seeking accreditation from organizations like The Joint Commission or CAP must complete this application. Similar to the CMS 116, it requires detailed information about laboratory operations, quality control measures, and testing capabilities, all aimed at ensuring high standards of laboratory practice.

The Application for a Certificate of Need (CON) is also relevant. While it primarily focuses on the necessity for new healthcare services or facilities, it shares the same goal of ensuring that healthcare providers meet specific standards. Both documents require comprehensive information about services offered and operational plans, reflecting a commitment to patient care and resource management.

The Laboratory Quality Management Plan is another similar document. This plan outlines how a laboratory will maintain quality and compliance with CLIA regulations. Like the CMS 116, it emphasizes the importance of systematic processes and procedures to ensure accurate and reliable laboratory testing.

The Laboratory Test Menu is also comparable. This document lists all tests a laboratory is authorized to perform, similar to the testing information required in the CMS 116. Both documents serve to inform stakeholders about the laboratory's capabilities and ensure that testing meets regulatory standards.

The Laboratory Information Management System (LIMS) documentation is another related document. LIMS tracks laboratory operations, including test results and quality control data. Similar to the CMS 116, it helps ensure compliance with CLIA regulations by providing a structured approach to managing laboratory information and operations.

Lastly, the Laboratory Safety Plan is similar in that it outlines protocols for maintaining a safe laboratory environment. Both documents reflect the importance of adhering to regulations and best practices to protect staff and patients. They emphasize the need for safety measures in laboratory operations, ensuring compliance with health and safety standards.

Dos and Don'ts

When filling out the CLIA Application CMS 116 form, it is crucial to ensure accuracy and completeness. Here are some important guidelines to follow:

Do complete all applicable sections of the form. Incomplete applications may lead to delays in processing.
Do provide accurate facility information. This includes the facility name, address, and federal tax identification number.
Do indicate the correct type of certificate requested. Make sure to check only one option that accurately describes your laboratory's operations.
Do include the anticipated start date. This helps in processing your application efficiently.
Do attach any required documentation. For example, if applying for a Certificate of Accreditation, include proof of accreditation from an approved organization.
Don’t forget to sign the application. An unsigned application will not be processed.
Don’t submit payment with the application. Payment should be sent separately to the appropriate agency as instructed.
Don’t use a P.O. Box for the facility address. A physical address is required for accurate correspondence.
Don’t overlook the importance of estimated annual test volumes. This information is essential for categorizing your laboratory’s testing capabilities.

Misconceptions

Understanding the CLIA Application CMS 116 form is essential for laboratories seeking certification. However, several misconceptions can lead to confusion during the application process. Here are five common misconceptions:

Misconception 1: The form can be submitted without all sections completed.

All applicable sections of the CMS 116 form must be filled out for the application to be processed. Incomplete forms can delay certification.

Misconception 2: Only large laboratories need to apply for CLIA certification.

Any laboratory performing testing on human specimens, regardless of size, must obtain CLIA certification. This includes small clinics and mobile testing units.

Misconception 3: The application process is the same for all types of certificates.

Different types of certificates—such as Certificate of Waiver, Certificate for Provider Performed Microscopy Procedures, and Certificate of Accreditation—require specific sections to be completed. Understanding these requirements is crucial.

Misconception 4: The CMS 116 form is only for initial applications.

The form is also used for changes in certificate type or for updates to existing certifications. Laboratories should submit the form whenever there are significant changes in operations.

Misconception 5: Submitting the form guarantees immediate certification.

Submitting the CMS 116 form does not guarantee immediate approval. The review process may take time, and laboratories must meet all regulatory requirements before certification is granted.

Key takeaways

Filling out the CLIA Application CMS 116 form can seem daunting, but understanding its key components can simplify the process. Here are some essential takeaways:

Complete All Sections: Ensure that every applicable section of the form is filled out. Incomplete forms can lead to delays in processing.
Identify Your Facility: Clearly state your facility name, address, and federal tax identification number. This information is crucial for proper identification.
Choose the Correct Certificate Type: Select the appropriate certificate type based on the testing your laboratory performs. Options include Certificate of Waiver, Certificate for Provider Performed Microscopy Procedures (PPM), Certificate of Compliance, and Certificate of Accreditation.
Understand Testing Requirements: Familiarize yourself with the specific requirements for each certificate type, especially regarding the qualifications needed for laboratory directors.
Indicate Testing Hours: Clearly list the hours during which laboratory testing is performed. This helps in scheduling inspections and ensuring compliance.
Multiple Sites: If your laboratory operates in multiple locations, indicate this on the form. You may need to meet specific regulatory exceptions to apply for a single certificate covering multiple sites.
Annual Test Volume: Provide an estimated annual test volume for all types of testing performed. This includes waived, PPM, and non-waived tests, as applicable.
Submit to the Right Agency: After completing the form, send it to your local State Agency. Avoid sending any payments with your application, as this can lead to complications.

By keeping these points in mind, you can navigate the CLIA Application CMS 116 form more confidently and efficiently. Proper preparation is key to ensuring your laboratory meets all necessary requirements.