Clia Application Cms 116 Form – Fill Out and Use This PDF

CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA)

APPLICATION FOR CERTIFICATION

ALL APPLICABLE SECTIONS OF THIS FORM MUST BE COMPLETED.

I. GENERAL INFORMATION

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.

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 LabExcellence@cms.hhs.gov.

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

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

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?

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?

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?

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?

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.

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.

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

Check if no waived tests are performed

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

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.

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)

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

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:

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

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

THE CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) APPLICATION

(FORM CMS-116)

INSTRUCTIONS FOR COMPLETION

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

VIII. NON-WAIVED TESTING

TESTS COMMONLY PERFORMED AND THEIR CORRESPONDING

LABORATORY SPECIALTIES/SUBSPECIALITIES

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.

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.