(a) An application for a medical
laboratory license shall be made under oath, by the owner and director of the
medical laboratory or public official responsible for the operation of a city
or county medical laboratory or institution that contains a medical laboratory,
upon forms provided by the Board.
(b) All laboratories performing tests must
file a separate application for each laboratory address.
(c) Laboratories within a hospital that are
located in contiguous buildings on the same campus and under common direction
may file a single application or multiple applications for the laboratory sites
within the same physical location or street address.
(d) Each application shall include, in
alphabetical order, a roster of all personnel currently employed in the
laboratory, the classification/category in which the employee functions and is
licensed, license number, expiration date and social security number. This
shall include all medical laboratory directors, consultants, supervisors and
application will be returned to the applicant if it is incomplete or requires
(f) After submission of
the completed application, the laboratory or collection station may be issued a
letter of temporary license which shall be valid for a period of not longer
than three (3) months from the date the application is received by the Board.
This temporary license will allow the laboratory to perform testing and allow
the collection station to collect specimens until an on-site inspection is
conducted and a determination is made whether the laboratory or collection
station is in compliance. The laboratory shall be fully operational, including
but not limited to the reporting of patient results, at the time of the on-site
inspection. The collection station shall be fully operational at the time of
the on-site inspection. If the laboratory or collection station is found to be
in compliance, it shall be issued a permanent license, provided all other
requirements for licensure have been met.
License - Issued
(a) A license shall be issued authorizing the
performance of one (1) or more medical laboratory specialties or
subspecialties, the location of testing, the name of the laboratory director
and type of ownership.
license shall be issued authorizing the collection of specimens, the location
of collection, the name of the physician and type of ownership.
(c) A license shall be valid only in the
hands of the person or persons to whom it is issued and shall not be the
subject of sale, assignment, or transfer, voluntary or involuntary, nor shall a
license be valid for any premises other than those for which issued.
(d) The license shall be displayed at all
times in a prominent place where it may be viewed by the public.
Fees - The fees established by
the Board pursuant to the Tennessee Medical Laboratory Act (T.C.A. §§
, et seq.) for licensure
are as follows:
Laboratory Application Fee - This fee is nonrefundable.
License Renewal Fee - To be paid annually by all licensees.
Laboratory License or Collection Station Renewal Penalty Fee -To be paid when a
licensee fails to timely renew annual license.
|| Annual State
Regulatory Fee - To be paid by all licensees.
License (other than 1200-06-03-.03 ) when lost or
Collection Station Application Fee
Station Renewal Fee
|| T.C.A. §
68-29-112 Fee - A nonrefundable
fee to be paid when there is a change in laboratory ownership, directorship, or
Fees may be paid in the following manner:
All fees paid by money order, certified, personal, or corporate check must be
submitted to the Board's Administrative Office and made payable to the
Tennessee Medical Laboratory Board.
(b) Fees may be paid by Division-approved
credit cards or other Division-approved electronic methods.
Pursuant to T.C.A. §
Board hereby exempts the following laboratories (or portions of otherwise
licensed laboratories) and the personnel performing tests in those laboratories
(or portions of otherwise licensed laboratories) from the requirements imposed
pursuant to the "Tennessee Medical Laboratory Act":
(a) Any laboratory (or portion of an
otherwise licensed laboratory) which is operated by the Tennessee Department of
Health and in which the only testing on human specimens is that which is
required pursuant to an investigation ordered by or in cooperation with the
State Epidemiologist or law enforcement agency the results of which are
reported only to the State Epidemiologist, CDC or law enforcement officials as
required by federal law.
Tenn. Comp. R. &
Original rule filed
October 26, 1979; effective December 10, 1979. Amendment filed June 30, 1987;
effective August 14, 1987. Amendment filed February 21, 1991; effective April
7, 1991. Repeal and new rule filed January 7, 1997; effective March 23, 1997.
Amendment filed August 31, 2001; effective November 14, 2001. Repeal and new
rule filed June 18, 2002; effective September 1, 2002. Amendment filed July 8,
2004; effective September 21, 2004. Amendment filed December 27, 2006;
effective March 12, 2007. Amendment filed April 17, 2007; effective July 1,
2007. Amendment filed April 1, 2009; effective June 15,
Authority: T.C.A. §§
68-29-103, 68-29-104, 68-29-105,