The board is authorized to adopt, promulgate and publish rules and regulations to effectuate the purposes and provisions of this chapter, which shall include, but not be limited to, the following subject matters:

(1) The licensure of all medical laboratories and personnel and/or special analysts meeting the licensure requirements of this chapter;

Terms Used In Tennessee Code 68-29-105

  • Board: means the medical laboratory board, created by §. See Tennessee Code 68-29-103
  • Medical laboratory: means 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 or blood fractions, or for the training of medical laboratory personnel. See Tennessee Code 68-29-103
  • Medical laboratory evaluation program: means a program of evaluating the proficiency of medical laboratories by the department. See Tennessee Code 68-29-103
  • Medical laboratory personnel: includes the medical laboratory director, supervisor, technologist, or technician, but does not include medical laboratory assistants, trainees, or other persons employed by a medical laboratory to perform clerical or other administrative responsibilities involving no laboratory test. See Tennessee Code 68-29-103
  • Waived: means those laboratory tests systems cleared by the United States food and drug administration (FDA) for home use and those tests approved for waiver under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 U. See Tennessee Code 68-29-103
  • written: includes printing, typewriting, engraving, lithography, and any other mode of representing words and letters. See Tennessee Code 1-3-105
  • Year: means a calendar year, unless otherwise expressed. See Tennessee Code 1-3-105
(2) The determination of the qualification of medical laboratory personnel and/or special analysts by written, oral or practical examination;
(3) The operation of a medical laboratory evaluation program and the establishment of standards of performance in the examination of specimens. As part of the medical laboratory evaluation program, the board may require medical laboratory personnel or special analysts or both to analyze test samples submitted to them by the board or by an agency approved by the board and report on the results of the analysis;
(4) The establishment of standards for construction of new, or modification of existing medical laboratories, including plumbing, heating, lighting, ventilation, electrical services and similar conditions, that shall ensure the conduct and operation of the laboratory in a manner that will protect the public health;
(5) The establishment of standards relating to sanitary conditions within the medical laboratory and its surroundings, including water supply, sewage, the handling of specimens, and general hygiene that shall ensure the protection of the public health;
(6) The establishment of standards for medical laboratory equipment essential to proper conduct and operation of a medical laboratory;
(7) The training of medical laboratory personnel and/or special analysts;
(8) The definition and performance of waived tests;
(9) The establishment of standards for licensed health care facilities to perform point of care testing; and
(10) The establishment of continuing educational requirements for medical laboratory personnel and special analysts, which requirements shall not exceed twenty-five (25) hours per year, including, but not limited to, the review and approval of programs and courses.
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