An exception to
the requirements of 1200-06-03-.14
direction and supervision may be made for a licensed Ambulatory Surgical
Treatment Center (ASTC) providing the following are met:
(a) Condition: The laboratory is directed by
a physician currently licensed in Tennessee.
(b) Condition: The facility employs a
licensed technologist as laboratory supervisor.
(c) Condition: The facility participates
successfully in an approved proficiency testing program
(d) Condition: The facility is in substantial
compliance with laboratory regulations as determined by an on-site survey
conducted by a representative of the Department.
(e) Condition: The facility performs only the
following procedures: CBC, urinalysis, ABO grouping and Rh typing, Pregnancy
tests, Gram's stain, wet mounts and Rh immune globulin testing. Performance of
additional procedures will necessitate that the laboratory meet all regulatory
exception to the requirements of Rule
direction, supervision and technical laboratory personnel may be made for Blood
Donor Centers and Plasmaphersis Centers providing the following conditions are
(a) The laboratory is directed by a
physician licensed in Tennessee who possesses a current Tennessee
Screening tests for
the purpose of determining donor suitability are limited to:
1. Hemogoblin or hematocrit.
2. Total serum protein.
3. Dipstick urine test for glucose and
4. Urine drug screens for
opiates and morphine.
Screening tests for educational purposes are limited to blood groups (ABO) and
blood type (Rh).
(d) The personnel
performing the screening tests shall be trained in the performance of these
tests, quality control and recordkeeping duties. The Laboratory Director shall
have on record at the facility where the "trained personnel" are employed,
documentation of training with date(s) of training and signed by the person(s)
administering the training. These "training personnel" shall not be required to
have a medical laboratory personnel license.
The performance of additional testing
that includes but is not limited to donor accessing (ABO, Rh, Antibody
Detection and/or identification, STS, HIV, hepatitis tests, ALT, protein
electrophoresis, etc.) shall require the facility to comply with Rule
(g) The Donor Center/Plasmapheresis Center
shall report the results of all positive tests for hepatitis to the Division of
Communicable Disease Control of the Department within two (2) weeks after the
last day of each month. The report shall contain the name, address, birth date
and social security number of the donor and the name and address of the
(h) Any inquiries and/or
complaints referred to the Department in regard to donor selection, bleeding
products, etc. will be referred to the U.S. Food and Drug Administration for
Tenn. Comp. R. &
Original rule filed
October 26, 1979; effective December 10, 1979. Amendment filed December 14,
1981; effective January 28, 1982. Amendment filed September 30, 1987; effective
November 14, 1987. Repeal and new rule filed January 7, 1997; effective March
23, 1997. Amendment filed February 14, 2000; effective April 29, 2000.
Amendment filed December 1, 2000; effective February 14, 2001. Repeal and new
rule filed June 18, 2002; effective September 1, 2002. Amendment filed August
25, 2003; effective November 8, 2003. Amendments filed May 16, 2005; effective
July 30, 2005.
Authority: T.C.A. §§
68-29-104, and 68-29-105.