Direct Access Testing (DAT) and the Clinical Laboratory Improvement Amendments (CLIA) Regulations
MedSun: Newsletter #25, June 2008

The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 189,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification Group, under the Center for Medicaid and State Operations (CMSO) has the responsibility for implementing the CLIA Program.

The objective of the CLIA program is to ensure quality laboratory testing. Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities. For more information on Direct Access Testing (DAT) and the Clinical Laboratory Improvement Amendments (CLIA) Regulations please visit the website below:

Additional Information:

Direct Access Testing (DAT) and the Clinical Laboratory Improvement Amendments (CLIA) Regulations. FDA Website.

http://www.cms.hhs.gov/CLIA/downloads/DIrect_Access_Testing_(DAT).pdf


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