Section 1200-06-03-.01 - DEFINITIONSAs used in this chapter of Rules the following terms and acronyms shall have the following meanings ascribed to them:
(1) ASTC - Ambulatory Surgical Treatment Center, specifically any institution, place or building devoted primarily to the maintenance and operation of a facility for the performance of surgical procedures or any facility in which a medical or surgical procedure is utilized to terminate a pregnancy and is licensed by the Tennessee Board for Licensing Health Care Facilities under Rule 1200-8-10.(2) Anatomic laboratory - Any medical laboratory performing only the biophysical examination of specimens pertaining to the clinical specialty of pathology, to include histopathology, oral pathology, and cytopathology. The examination of these specimens taken from the human body are performed to obtain information for diagnosis, prophylaxis, or treatment or where any examination, determination or test is made of any sample used as a basis for health advice, or where any sample is collected for the purpose of transfusion or processing of blood or blood fractions, or the training of medical laboratory personnel. Compliance with Rule 1200-6-1-.20 is required to be the director of an anatomic laboratory.(3) Authorized person - A physician or intern or resident in an American Medical Association approved training program or a duly licensed optometrist or a duly licensed dentist or a duly licensed chiropractic physician or other health care professional legally permitted to submit to a medical laboratory a written request for tests appropriate to that professional's practice or a law enforcement officer acting in accordance with T.C.A. § 55-10-406.(4) Board - The Tennessee Medical Laboratory Board.(5) CLIA - The Clinical Laboratory Improvement Amendments as found in 42 CFR 493.(6) CLSI - The Clinical Laboratory and Standards Institute.(7) CMS - The Centers for Medicare and Medicaid Services of the U.S. Department of Health and Human Services.(8) Center for Disease Control (CDC) - The United States Center for Disease Control, headquartered in Atlanta, GA.(9) Clinical Laboratory - see Medical Laboratory.(10) Code of Federal Regulations (CFR) - The documents that detail under Title 42, Chapter IV Part 493, the Laboratory Requirements under CLIA, and under Title 21, Parts 600 to 799, the Food and Drug Requirements.(11) Condition - A specific requirement from the Board's rules that must be met for continued possession of a license to operate a medical laboratory in Tennessee. Unmet conditions of compliance with the Board's rules can result in harm to patients or facility personnel.(12) Condition Level Deficiency - A significant deficiency of non-compliance with a rule. A deficiency that must be corrected before a license is continued, issued or is renewed.(13) Days - Calendar days unless otherwise designated.(14) Department - The Department of Health, State of Tennessee.(15) FDA - The U.S. Food and Drug Administration.(16) HCF - The Department of Health, Division of Health Care Facilities.(17) HHS - The U.S. Department of Health and Human Services.(18) Human Leukocyte Antigens (HLA) - Identification of the human histocompatibility complex antigens on the surface of nucleated cells.(19) Independent Lab - A medical laboratory performing patient tests that is independent of both attending and consulting physician's offices and independent of a hospital also known as a reference laboratory.(20) Manufacturer's instructions - Information found on the FDA approved product label.(21) May - Discretionary.(22) Medical Laboratory - Any institution, building, or place in which operations and procedures for the microbiological, serological, chemical, hematological, immunohematological, or biophysical examination of specimens taken from the human body are performed to obtain information for diagnosis, prophylaxis, or treatment or where any examination, determination, or test is made on any sample used as a basis for health advice, or where any sample is collected for the purpose of transfusion or processing of blood fractions, or for the training of medical laboratory personnel.(24) Office for the Medical Laboratory Board - The Office responsible for laboratory facility licensure.(25) Performance Improvement (PI) - An ongoing process encompassing all facets of the laboratory or collection station technical and nontechnical functions at all locations/sites where testing is performed.(26) Plan of Correction - The laboratory's or collection station's response to any citation of non-compliance with regulations. The Plan of Correction must be reasonable, contain specific actions to correct deficiencies with estimated correction dates and contain the signature of the Laboratory Director or his authorized Designee or collection station director or his authorized designee.(27) Point of Care Laboratory Testing - Those tests performed by health care professionals, not licensed by this chapter, upon approval by the board, provided that the testing is performed outside the duly licensed laboratory, and under the auspices of a laboratory required to be licensed by the division of health care facilities in the department of health, pursuant to this chapter.(28) Physician Office Laboratory - A laboratory operated by a duly licensed physician for the sole purpose of testing samples collected from their own patients.(29) Reference Laboratory - A medical laboratory performing patient tests that is independent of both attending and consulting physician's offices and independent of a hospital also known as an independent laboratory.(31) Standard - A specific requirement from the state rules that must be met for continued possession of a license to operate a medical laboratory or collection station in Tennessee. Unmet standards of compliance usually reflect unsatisfactory performance of laboratory or collection station operations according to accepted standards of medical laboratory practice.(32) Standard Level Deficiency - A deficiency of non-compliance with a regulation for which a license would be issued or renewed, provided an acceptable plan of correction with an estimated completion date has been submitted and approved.(33) Statement of Deficiencies - An official notification of non-compliance with one (1) or more regulatory requirements.(34) Unsatisfactory Proficiency Testing Performance - Failure to attain the minimum satisfactory score for an analyte, test, subspecialty, or specialty for a testing event.(35) Unsuccessful Proficiency Testing Performance - Failure to attain the minimum satisfactory score for an analyte, test, subspecialty, or specialty for two (2) consecutive or two (2) of three (3) consecutive testing events.Tenn. Comp. R. & Regs. 1200-06-03-.01
Original rule filed October 26, 1979; effective December 10, 1979. Amendment filed December 14, 1981; effective January 28, 1982. Amendment filed June 30, 1987; effective August 14, 1987. Repeal and new rule filed May 15, 1990; effective June 29, 1990. Amendment filed November 30, 1990; effective January 14, 1991. Amendment filed February 21, 1991; effective April 7, 1991. Repeal filed May 3, 1995; effective July 17, 1995. New rule filed January 7, 1997; effective March 23, 1997. Repeal and new rule filed June 18, 2002; effective September 1, 2002. Amendment filed May 23, 2003; effective August 6, 2003. Amendment filed March 14, 2006; effective May 28, 2006.Authority: T.C.A. §§ 4-5-202, 4-5-204, 68-29-103, 68-29-105, 63-29-111, 68-29-116, and Public Acts of 2002, Chapter 623.