Clinical Laboratory Improvement Amendments (CLIA) Application For Certification {CMS-116} | Pdf Fpdf Docx | Official Federal Forms

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Clinical Laboratory Improvement Amendments (CLIA) Application For Certification {CMS-116} | Pdf Fpdf Docx | Official Federal Forms

Clinical Laboratory Improvement Amendments (CLIA) Application For Certification {CMS-116}

This is a Official Federal Forms form that can be used for Centers For Medicare And Medicaid Services.

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1 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 I. GENERAL INFORMATION Initial Application Survey Change in Certificate Type Other Changes (Specify) Effective Date CLIA IDENTIFICATION NUMBER D (If an initial application leave blank, a number will be assigned) FACILITY NAME FEDERAL TAX IDENTIFICATION NUMBER EMAIL ADDRESS TELEPHONE NO. (Include area code) FAX NO. (Include area code) FACILITY ADDRESS 227 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 NUMBER, STREET (No P.O. Boxes) MAILING/BILLING ADDRESS (If different from facility address) send Fee Coupon or certificate NUMBER, STREET CITY STATE ZIP CODE CITY STATE ZIP CODE SEND FEE COUPON TO THIS ADDRESS Physical Mailing Corporate SEND CERTIFICATE TO THIS ADDRESS Physical Mailing Corporate CORPORATE ADDRESS (If different from facility) send Fee Coupon or certificate NUMBER, STREET NAME OF DIRECTOR (Last, First, Middle Initial) CITY STATE ZIP CODE 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 226 VI and IX 226 X) Certificate for Provider Performed Microscopy Procedures (PPM) ((Complete Sections I-VII and IX-X) Certificate of Compliance (Complete Sections I 226 X) Certificate of Accreditation (Complete Sections I 226 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 AOA AABB A2LA CAP COLA 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 regulations. Proof of these qualifications for the laboratory director must be submitted with this application. 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: 3/31/2021. 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. Form CMS-116 (09/17) American LegalNet, Inc. www.FormsWorkFlow.com 2 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) III. TYPE OF LABORATORY (Check the one most descriptive of facility type) 01036036 Ambulance 11 Health Main. Organization 22 Practitioner Other (Specify) 02 Ambulatory Surgery Center 12 Home Health Agency 03 Ancillary Testing Site in 13 Hospice 23036036 PrisonHealth Care Facility 14 Hospital 24036036 Public Health Laboratories04 Assisted Living Facility 15 Independent 25036036 Rural Health Clinic05036036 Blood Bank 16036 036 Industrial 26 School/Student Health Service06 Community Clinic 17036036 Insurance 27 Skilled Nursing Facility/07 Comp. Outpatient Rehab Facility 18 Intermediate Care Facilities for Nursing Facility08 End Stage Renal Disease Individuals with Intellectual 28 Tissue Bank/RepositoriesDialysis Facility Disabilities 29 Other (Specify)09 Federally Qualified 19 Mobile Laboratory Health Center 20 Pharmacy 10036036 Health Fair 21 Physician Office 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 facility222s 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 No 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 No037037 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 No037037 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.037037 If additional space is needed, check here and attach the additional information using the same format. American LegalNet, Inc. www.FormsWorkFlow.com 3 In the next three sections, indicate testing performed and 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. 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 and attach additional information using the same format.If additional space is needed, check here VII.PPM TESTING If only applying for a Certificate for PPM, complete this section and skip section VIII (Non-Waived Testing).Identify the PPM testing (to be) 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 037037 If also performing waived com

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