Tenn. Comp. R. & Regs. 1200-06-03-.17 - WAIVED TESTING

(1) Definition: "Waived" means those laboratory tests, as defined by the Board, which may be performed by individuals not licensed under the Medical Laboratory Act, and which pose no reasonable risk of harm if performed incorrectly.
(2) Clinical laboratory tests which are designated as waived shall:
(a) be determined by the Board;
(b) be an analyte and/or methodology previously deemed as waived under CLIA; and
(c) apply to any and all testing sites
(3) Clinical laboratories, pharmacies, and other health care facilities licensed by the State of Tennessee who perform waived testing must comply with the following minimum guidelines:
(a) Notification must be provided to the Administrative Office for the Board using Board approved forms and protocols.
(b) Performance of waived testing by a licensed medical laboratory must be approved by a Medical Laboratory Director as defined by the Tennessee Medical Laboratory Act, T.C.A. § 68-29-103.
(c) In the absence of a Medical Laboratory Director as defined by the Tennessee Medical Laboratory Act, T.C.A. § 68-29-103, performance of waived testing must be approved by the physician legally responsible for laboratory testing performed by that health care facility or pharmacy.
(d) Personnel must perform such testing in accordance with manufacturer recommendations, including quality control.
(e) Patient test results must be recorded in a clinical record, to include date and time of specimen collection, units of measurement and identity of analyst performing the test.
(f) The laboratory, pharmacy, or health care facility must identify personnel responsible for performing and supervising the waived testing.
(g) Personnel performing the waived testing must have adequate, specific training and orientation to perform the tests, and must demonstrate satisfactory levels of competence before performing patient testing, and at a minimum, annually thereafter.
(h) Performance of waived testing will be evaluated by Laboratory surveyors at the time of inspection.


Tenn. Comp. R. & Regs. 1200-06-03-.17
Original rule filed June 18, 2002; effective September 1, 2002.

Authority: T.C.A. §§ 4-5-202, 4-5-204, 68-29-104, and 68-29-105.

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