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For Questions regarding a CLIA certificate or fees: If you have a question related to CLIA fees or payment, CMS-116 applications, demographic updates, certificate status or upgrades, and/or Laboratory Director changes, please call your local State agency for assistance.Additionally, see the Temporary COVID-19 Testing Sites (PDF) infographic, which advises those receiving laboratory services of things to be aware of to ensure they are receiving quality laboratory testing.

#Cfs to cms how to

See the Consumer Complaints FAQ (PDF) on how to file a complaint. To report a complaint about a laboratory, contact the appropriate State Agency (PDF) that is found on the State Agency & Regional Office CLIA Contacts page located in the left-hand navigation pane in this section. Frequently asked questions to S&C-16-18-CLIA, Personnel Policies for Individuals Directing or Performing Non-waived Tests, are in the Downloads section file called 'S&C-16-18-CLIA FAQs'.CDC educational booklet, 'PROVIDER-PERFORMED MICROSCOPY PROCEDURES - A Focus on Quality Practices' (In the Related Links section.) and.FDA Safety Tip for laboratories on how workload should be calculated when using currently FDA-approved semi-automated gynecologic cytology screening devices and.

#Cfs to cms download

Information on alternative (non-traditional) laboratory is contained in the Special Alert download.

Micro sample pipetting information for laboratories.

Guidance for Coordination of CLIA Activities Among CMS Central Office, CMS Regional Offices, State Agencies (including State with Licensure Requirements), Accreditation Organizations and States with CMS Approved State Laboratory Programs is contained in the Partners in Laboratory Oversight download.

Information about direct access testing (DAT) and the CLIA regulations is included in the Direct Access Testing download.

Information on research testing and CLIA is found in the file called 'Research Testing and CLIA'.

CMS Blog - FDA & CMS Form Task Force on LDT Quality Requirements.

Information about what is CMS’ authority regarding Laboratory Developed Tests (LDTs) and how does it differ from FDA’s authority is found in the downloads section in the file called 'LDT and CLIA FAQs'.

For additional information about a particular laboratory, contact the appropriate State Agency (PDF) or CLIA.

Frequently asked Questions (FAQs), Abbott i-STAT.

Frequently Asked Questions (FAQs), CLIA Guidance During the COVID-19 Emergency.

Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities.įor the following information, refer to the downloads/links listed below: The objective of the CLIA program is to ensure quality laboratory testing. The Division of Clinical Laboratory Improvement & Quality, within the Quality, Safety & Oversight Group, under the Center for Clinical Standards and Quality (CCSQ) has the responsibility for implementing the CLIA Program. In total, CLIA covers approximately 330,000 laboratory entities.

through the Clinical Laboratory Improvement Amendments (CLIA). The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S.