Tenn. Comp. R. & Regs. 1200-06-03-.19 - PREPARATORY PORTIONS OF LABORATORY TESTS

(1) Tennessee Code Annotated, Section 68-29-129 makes it a violation of the law to allow any person to perform "medical laboratory procedures" except individuals licensed and registered under this chapter. For purposes of that section, the words "medical laboratory procedures" include only the non-preparatory portions of any test required to be performed in a medical laboratory. The preparatory portions of the tests, while they must be performed in a facility licensed by the Board, do not require the extensive education and specialized knowledge required for licensure and may therefore be performed by persons not licensed under the Medical Laboratory Act.

(2) The following are considered to be preparatory portions of tests to be performed in a medical laboratory that may be assigned to persons not licensed under the Medical Laboratory Act:

(a) centrifuging, pouring off and preparing specimens for testing.

(b) preparing peripheral smears at bedside or in the laboratory.

(c) staining peripheral smears by automated methods.

(d) loading primary bar-coded specimens on analyzers.

(e) automated process of sorting, decapping, aliquoting and archiving of specimens.

(f) primary inoculation of microbiology specimens.

(g) Any activities required prior to microscopic evaluation of cytology specimens.

(3) A medical laboratory director, as defined by T.C.A. § 68-29-103, must approve preparatory portions of tests performed by individuals not licensed under the Tennessee Medical Laboratory Act.

(4) The laboratory must identify personnel responsible for performing preparatory portions of tests and those with responsibility for supervising them.

(5) Personnel performing preparatory portions of tests must have adequate, specific training and orientation and must demonstrate satisfactory levels of competency before performing preparatory portions of tests, and a competency demonstration must be performed at least annually thereafter.

(6) Laboratory surveyors will evaluate preparatory portions of tests at the time of inspection.

Notes

Tenn. Comp. R. & Regs. 1200-06-03-.19

Original rule filed April 10, 2003; effective June 24, 2003. Amendment filed September 17, 2003; effective December 1, 2003. Amendment filed April 17, 2007; effective July 1, 2007.

Authority: §§ 4-5-202, 4-5-204, 68-29-105, and 68-29-129.