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.
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|Laws and Rules Governing Pharmacy Practice Related to Point-of-Care, Ordering Laboratory Tests, and Collaborative Pharmacy Practice
- Tennessee Medical Laboratory Board rules 1200-06-03-.16 (Alternate Site Testing) and 1200-06-03-.17 (Waived Testing) authorize pharmacists, and pharmacy interns under the personal supervision and in the presence of a pharmacist, to provide Waived Point-of-Care tests after the pharmacy has obtained a CLIA Waiver from the federal government and completed and filed a Waived Testing notification form created by the Tennessee Medical Laboratory Board.
- Tennessee Code Annotated (TCA) 63-10-204 (39) (A) “Practice of pharmacy” authorizes pharmacists, and pharmacy interns under the personal supervision and in the presence of a pharmacist, to perform Tennessee-approved Waived tests. Specifically, the “Practice of pharmacy” includes (i) Interpretation, evaluation and implementation of medical orders and prescription orders; (vii) Provision of patient care services and activities pursuant to a collaborative pharmacy practice agreement; and (ix) Those professional acts, professional decisions or professional services necessary to maintain all areas of a patient’s pharmacist-provided care.
- Tennessee Code Annotated (TCA) 63-10-204 (39) (B) “Practice of pharmacy” authorizes pharmacists, and pharmacy interns under the personal supervision and in the presence of a pharmacist, to conduct and assist patients with tests approved for home use (i.e., Tennessee-approved Waived tests), as well as order and convey laboratory tests and prescribe prescription drugs, pursuant to a medical order by the attending prescriber for each patient or pursuant to a collaborative pharmacy practice agreement jointly agreed upon by a pharmacist or pharmacists and a prescriber or prescribers.
|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
- Waived Point-of-Care (POC) Tests approved by the Tennessee Medical Laboratory Board.
- Waived Health Fair/Health Screening Tests approved by the Tennessee Medical Laboratory Board.
- If pharmacists wish to perform Point-of-Care tests which are not included on the state’s Waived Point-of-Care tests and/or the state’s Waived Health Fair/Health Screening tests, they must request approval from the Tennessee Medical Laboratory Board for permission to perform each specific additional test.
|STEP 3: Obtain, complete, and file a Tennessee Waived Point-of-Care Testing Notification Form
|STEP 4: Health Fairs and Health Screenings
- Not-for-profit organizations (including not-for-profit pharmacies) are permitted to perform Tennessee-approved waived tests at Health Fairs and Health Screenings, only after completing the Tennessee Health Fair/Health Screen Form.
- The form must be signed by a supervising physician and filed with the Tennessee Medical Laboratory Board at least 10 days in advance of each event being held.
- The supervising physician is responsible for general oversight and review of testing results.
- A copy of the supervising physician’s medical license must be submitted with the form.
- The Tax ID for the not-for-profit must be included.
- Pharmacists, and pharmacy interns under the personal supervision and in the presence of a pharmacist, are permitted to perform any waived tests which are listed on Tennessee’s Waived Test-Health Fair/Health Screening Program.
- Not-for-profit organizations (including not-for-profit pharmacies) should also obtain an active, valid federal CLIA waiver (CMS-116).
|Additional Suggested Training Program: Pharmacist-Provided Point-of-Care Testing