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Clinical Laboratory Improvement Amendments Of 1988 (CLIA) Application For Certification CMS-116 - Official Federal Forms
| Clinical Laboratory Improvement Amendments Of 1988 (CLIA) Application For Certification Form. This is a national form and can be used in Centers For Medicare And Medicaid Services . |
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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 Change in Certification Type Other Changes (Specify) FACILITY NAME Survey CLIA IDENTIFICATION NUMBER _______________D________________________ (If an initial application leave blank, a number will be assigned) FEDERAL TAX IDENTIFICATION NUMBER EMAIL ADDRESS TELEPHONE NO. (Include area code) FAX 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 address is specified MAILING/BILLING ADDRESS (If different from street address) NUMBER, STREET (No P.O. Boxes) NUMBER, STREET CITY STATE ZIP CODE CITY STATE ZIP CODE NAME OF DIRECTOR (Last, First, Middle Initial) FOR OFFICE USE ONLY Date Received ____________________________________________________ II. TYPE OF CERTIFICATE REQUESTED (Check only one) Certificate of Waiver (Complete Sections I VI and IX X) Certificate for Provider Performed Microscopy Procedures (PPM) (Complete Sections I X) Certificate of Compliance (Complete Sections I X) Certificate of Accreditation (Complete Sections I 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 AOA COLA AABB ASHI 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. NOTE: Laboratory directors performing non-waived testing (including PPM) must meet specific education, training and experience under subpart M of the CLIA requirements. Proof of these requirements for the laboratory director must be submitted with the application. 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. The time required to complete this information collection is estimated to average 30 minutes to 2 hours per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. If you have any comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS, Attn: PRA Reports Clearance Officer, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Form CMS-116 (10/10) American LegalNet, Inc. www.FormsWorkFlow.com 1 III. TYPE OF LABORATORY (Check the one most descriptive of facility type) 01 Ambulance 11 Health Main. Organization 12 Home Health Agency 13 Hospice 14 Hospital 15 Independent 16 17 Industrial Insurance 23 24 25 22 Practitioner Other (Specify) ______________________________ Prison Public Health Laboratories Rural Health Clinic 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 26 School/Student Health Service 27 Skilled Nursing Facility/ Nursing Facility 28 Tissue Bank/Repositories 29 Other (Specify) ______________________________ Yes No 18 Intermediate Care Facility for Mentally Retarded 19 Mobile Laboratory 20 Pharmacy 21 Physician Office Is this a shared lab? IV. HOURS OF LABORATORY TESTING (List times during which laboratory testing is performed in HH:MM format) SUNDAY FROM: TO: (For multiple sites, attach the additional information using the same format.) MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY SATURDAY V. MULTIPLE SITES (must meet one of the regulatory exceptions to apply for this provision) Are you applying for the multiple site exception? No. If no, go to section VI. 1. 2. Yes. If yes, complete remainder of this section. Indicate which of the following regulatory exceptions applies to your facility's operation. Is this a laboratory that has temporary testing sites? Yes No 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 No If yes, provide the number of sites under the certificate____________ and list name, address and test performed for each site below. 3. Is this a hospital with several laboratories located at contiguous buildings on the same campus within the same physical location or street address and under common direction that is filing for a single certificate for these locations? Yes No If yes, provide the number of sites under this certificate____________ and list name or department, location within hospital and specialty/subspecialty areas performed at each site below. If additional space is needed, check here and attach the additional information using the same format. NAME AND ADDRESS/LOCATION NAME OF LABORATORY OR HOSPITAL DEPARTMENT TESTS PERFORMED/SPECIALTY/SUBSPECIALTY 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 (10/10) American LegalNet, Inc. www.FormsWorkFlow.com 2 In the next three sections, indicate testing performed and annual test volume. VI. WAIVED TESTING Identify the waived testing performed. Be as specific as possible. This includes each analyte test system or device used in the laboratory. e.g. (Rapid Strep, Acme Home Glucose Meter) Indicate the estimated TOTAL ANNUAL TEST volume for all waived tests performed ________________ Check if no waived tests are performed VII. PPM TESTING Identify the PPM testing performed. Be as specific as possible. e.g. (Potassium Hydroxide (KOH) Preps, Urine Sediment Examinations) Indicate the estimated TOTAL ANNUAL TEST volume for all PPM tests performed ________________ For laborator
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