Inspections of Licensed Laboratories
Board or its Designee will conduct announced and/or unannounced inspections on
at least a biennial basis of any laboratory at any time during its hours of
operation to assess compliance with the applicable requirements.
(b) It is board policy that regular biennial
inspections be unannounced.
Written reports of inspection results will be submitted to the medical
laboratory director within ten (10) working days of the on-site
(d) The medical laboratory
director must respond to any deficiencies cited with a written plan of
correction that includes estimated correction dates, within ten (10) working
days of the receipt of the statement of deficiencies.
(2) Inspection for Initial License - The
laboratory shall be issued an initial license only after an on-site inspection
is conducted and the laboratory has no deficiencies, or has submitted an
acceptable plan of correction for all standard level deficiencies. All
condition level deficiencies must be corrected before the laboratory shall be
issued a license.
Tenn. Comp. R. &
Original rule filed
October 26, 1979; effective December 10, 1979. Amendment filed December 14,
1981; effective January 28, 1982. Repeal and new rule filed January 7, 1997;
effective March 23, 1997. Repeal and new rule filed June 18, 2002; effective
September 1, 2002.
Authority: T.C.A. §§
68-29-105, 68-29-106, and