Section 1200-06-03-.04 - INSPECTIONS - REPORTS(1) Biennial Inspections of Licensed Laboratories (a) The 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.(c) Written reports of inspection results will be submitted to the medical laboratory director within ten (10) working days of the on-site visit.(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. & Regs. 1200-06-03-.04
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. §§ 4-5-204, 4-5-204, 68-29-105, 68-29-106, and 68-29-113.