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Get CMS-116 2020-2024

Qualifications. Do not send any money with your application. Send the completed Form CMS-116 to the appropriate State Agency http //www. 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. 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 Reminders - Before submitting the Form CMS-116 Include the current or estimated annual test volume. Cms. gov/Regulations-and-Guidance/ 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. Cms. gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA. pdf 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. Hhs. gov. Form CMS-116 09/17 III. TYPE OF LABORATORY Check the one most descriptive of facility type 01 Ambulance 02 Ambulatory Surgery Center 03 Ancillary Testing Site in Health Care Facility 04 Assisted Living Facility 05 Blood Bank 06 Community Clinic 07 Comp. Outpatient Rehab Facility 08 End Stage Renal Disease Dialysis Facility 09 Federally Qualified Health Center 10 Health Fair Health Main. Organization Home Health Agency Hospice Hospital Independent Industrial Insurance Intermediate Care Facilities for Individuals with Intellectual Disabilities 19 Mobile Laboratory 20 Pharmacy 21 Physician Office 22 Practitioner Other Specify Prison Public Health Laboratories Rural Health Clinic School/Student Health Service Skilled Nursing Facility/ Nursing Facility 28 Tissue Bank/Repositories 29 Other Specify IV. DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE MEDICAID SERVICES Form Approved OMB No* 0938-0581 CLINICAL LABORATORY IMPROVEMENT AMENDMENTS CLIA APPLICATION FOR CERTIFICATION I. GENERAL INFORMATION Initial Application Survey CLIA IDENTIFICATION NUMBER Change in Certificate Type D Other Changes Specify If an initial application leave blank a number will be assigned Effective Date FACILITY NAME FEDERAL TAX IDENTIFICATION NUMBER EMAIL ADDRESS TELEPHONE NO. Include area code FACILITY ADDRESS Physical Location of Laboratory Building Floor Suite if applicable. Fee Coupon/Certificate will be mailed to this Address unless mailing or corporate address is specified MAILING/BILLING ADDRESS If different from facility address send Fee Coupon NUMBER STREET No P. O. Boxes CITY STATE ZIP CODE FAX NO. Include area code or certificate SEND FEE COUPON TO THIS ADDRESS SEND CERTIFICATE TO THIS ADDRESS CORPORATE ADDRESS If different from facility send Fee Coupon or certificate Physical Mailing Corporate NAME OF DIRECTOR Last First Middle Initial CREDENTIALS FOR OFFICE USE ONLY Date Received II.

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