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POINT-OF-CARE TESTING

Point-of-Care Testing


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Introduction:

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) is a federal program governed by the Centers for Medicare and Medicaid Services (CMS). Its purpose is to establish quality standards for clinical laboratory testing to ensure that patient test results are accurate and reliable.

In Tennessee, the Office of Health Care Facilities administers the certification of laboratory programs in accordance with CLIA regulations. The CLIA program is regulated for compliance under guidelines set forth in Federal Regulations 42 CFR Parts §493.1 through §493.1850.

Working through the Tennessee CLIA State Agency (SA), the CLIA program monitors all clinical laboratories located in hospitals, physician offices, clinics, pharmacies, and other health service facilities throughout the state of Tennessee. The Agency is responsible for monitoring and certifying over 6,000 laboratories, conducting on-site inspections for compliance, ensuring accuracy and reliability of laboratory testing via proficiency desk review, and investigating complaints.

  • Laws and Rules Governing Pharmacy Practice Related to Point-of-Care, Ordering Laboratory Tests, and Collaborative Pharmacy Practice
  • STEP 1: Obtain, complete, and file a federal CLIA Waiver form
  • STEP 2: Confirm that all Point-of-Care Tests provided by the pharmacy are approved by the state of Tennessee
  • STEP 3: Obtain, complete, and file a Tennessee Waived Point-of-Care Testing Notification Form
  • STEP 4: Health Fairs and Health Screenings
  • Additional Suggested Training Program: Pharmacist-Provided Point-of-Care Testing