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DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICESForm Approved OMB No. 09380581CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CIA) APPLICATION FOR CERTIFICATION I. GENERAL
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How to fill out clia application for certification

01
Gather all necessary information and documents required for the CLIA application such as laboratory director qualifications, testing personnel qualifications, laboratory personnel requirements, etc.
02
Complete the CMS-116 application form available on the CLIA website or through the local State Agency office.
03
Submit the completed application form along with any supporting documents and payment of applicable fees to the address provided on the form.
04
Wait for the application to be processed and reviewed by CLIA officials. This may take several weeks to months depending on the volume of applications received.
05
Once the application is approved, you will receive a CLIA certificate which must be prominently displayed in your laboratory.

Who needs clia application for certification?

01
Any laboratory that performs testing on human specimens for the purpose of diagnosis, prevention, or treatment of diseases requires CLIA certification.
02
This includes clinical laboratories, physician office laboratories, hospitals, blood banks, and other facilities that perform testing on human specimens.
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CLIA application for certification is the process healthcare facilities must undergo to obtain certification under the Clinical Laboratory Improvement Amendments.
Any facility or laboratory performing testing on human specimens for the purpose of diagnosis, prevention, or treatment of disease must file a CLIA application for certification.
The CLIA application for certification can be filled out online through the CMS website or by submitting a paper application to the appropriate state agency.
The purpose of the CLIA application for certification is to ensure that laboratories meet quality standards and provide accurate and reliable test results.
The CLIA application for certification typically requires information about the laboratory's personnel, testing procedures, quality control measures, and proficiency testing participation.
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