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.
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.
preparing peripheral smears at bedside or in the laboratory.
(c) staining peripheral smears by automated
(d) loading primary
bar-coded specimens on analyzers.
(e) automated process of sorting, decapping,
aliquoting and archiving of specimens.
(f) primary inoculation of microbiology
(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
surveyors will evaluate preparatory portions of tests at the time of
Tenn. Comp. R. &
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,
68-29-105, and 68-29-129.