clia license | How to Apply for a CLIA Certificate, Including Internat

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How to Apply for a CLIA Certificate, Including International
cms.gov

https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/apply

WEBApplying for a CLIA Certificate. What Form Do I Use to Apply? Complete the Application for Certification Form (CMS-116) (PDF), unless you're: A New York state non-physician office laboratory applicant. Email or call the New York State Department of Health at (518) 485-5378 for guidance. A Washington state applicant.

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Clinical Laboratory Improvement Amendments (CLIA) | CDC
cdc.gov

https://www.cdc.gov/clia/index.html

WEBPrint. The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease.

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How to obtain a CLIA Certificate - Centers for Medicare & …
cms.gov

https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/howobtaincliacertificate.pdf

WEBThe CLIA application (Form CMS-116) is available online. Send your completed application to the address of the local State Agency for the State in which your laboratory is located. Additionally, check with your State Agency for any other state-specific requirements.

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Clinical Laboratory Improvement Amendments (CLIA) | FDA
fda.gov

https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clinical-laboratory-improvement-amendments-clia

WEBUnder the CLIA program, clinical laboratories are required to have the appropriate certificate before they can accept human samples for testing. There are different types of CLIA certificates,...

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LABORATORY QUICK START GUIDE TO CMS CLIA …
cms.gov

https://www.cms.gov/files/document/laboratory-quick-start-guide-cms-clia-certification-november-2021.pdf

WEBperformed. CLIA has regulatory requirements for quality that all laboratories must meet. This guide helps laboratories seeking to apply for CLIA certification from CMS. More information can be found on the CMS CLIA website. STEP 1: Download and Complete Form CMS-116 •Include information based on the date of form completion.

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CLIA Law & Regulation - Centers for Disease Control and Prevention
cdc.gov

https://www.cdc.gov/clia/law-regulations.html

WEBThe Clinical Laboratory Improvement Amendments of 1988 statute is an amendment to the Public Health Services Act in which Congress revised the federal program for certification and oversight of clinical laboratory testing. Two subsequent amendments were made after 1988. The law continues to be cited as CLIA ’88 as named in legislation.

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CLIA Program and Medicare Laboratory Services - HHS.gov
hhs.gov

https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/cliabrochuretextonly.pdf

WEBTo get CLIA certification, laboratories must: 1. Complete Form CMS-116, Clinical Laboratory Improvement Amendments (CLIA) Application for Certification, and mail it to the appropriate CLIA State Agency. 2. Pay applicable fees based on certification type. For moderate and high complexity laboratories,

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About CLIA | CDC - Centers for Disease Control and Prevention
cdc.gov

https://www.cdc.gov/clia/about.html

WEBThe Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease.

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NC DHSR AHCLCS: Clinical Laboratory Improvement Amendments (CLIA)
ncdhhs.gov

https://info.ncdhhs.gov/dhsr/ahc/clia/index.html

WEBWhat is CLIA? The Clinical Laboratory Improvement Amendments of 1988 (CLIA) establish quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed.

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NC DHSR AHCLCS CLIA: Frequently Asked Questions
ncdhhs.gov

https://info.ncdhhs.gov/dhsr/ahc/clia/cliafaq.html

WEBApr 25, 2019 · No, North Carolina follows the CLIA regulations and does not have separate state licensure requirements for laboratories or laboratory personnel. 3. Where do I get a CLIA application? An application can be downloaded (printed) from the Centers for Medicare and Medicaid Services (CMS) Web site for CLIA. 4.

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