Tenn. Comp. R. & Regs. 1200-06-01-.01 - DEFINITIONS
This section sets forth the more important and/or frequently used terms and acronyms used in these rules and the meanings to be ascribed to them.
(1) Accrediting Bureau of Health
Education Schools (ABHES). Accreditation organization in the United States
specializing in the accreditation of institutions that offer allied health
education programs leading to associate degrees or certificates for medical
laboratory technicians and provides a pathway for certification by the American
Medical Technologists.
(2) The Act.
The Tennessee Medical Laboratory Act.
(3) Applicant. Any individual seeking
licensure by the Board and who has submitted an official application and paid
all required fees.
(4) Board. The
Tennessee Medical Laboratory Board.
(5) Board Administrative Office. The office
of the administrator assigned to the Board located at 665 Mainstream Drive,
Nashville, TN 37243.
(6) CLIA. The
Clinical Laboratory Improvement Amendments of 1988 as found in 42 CFR Part
493.
(7) Closed File. An
administrative action which renders an incomplete or denied file
inactive.
(8) Commission on
Accreditation of Allied Health Education Programs (CAAHEP). Accreditation
agency that accredits laboratory training programs.
(9) Committee. The Personnel and Education
Licensure Committee which oversees all matters pertaining to the licensure of
medical laboratory personnel and of medical laboratory education
programs.
(10) Continuing
Education. Planned, organized learning acts acquired during licensure to
maintain, improve, or expand a licensee's knowledge and skills relevant to
medical laboratory practice in order for the licensee to develop knowledge and
skills relevant to the practice, education, or theory development to improve
the safety and welfare of the public.
(11) Cytology Supervisor. A person who is
responsible for day-to-day supervision or oversight of the cytology laboratory
operation, personnel performing testing and reporting test results.
(12) Cytotechnologist. A person who processes
and interprets cellular material delineating data regarding cytopathological
disease with minimal supervision by the director or supervisor.
(13) Department. Tennessee Department of
Health.
(14) Esoteric Laboratory
Personnel. Personnel performing testing in an esoteric laboratory licensed
under T.C.A. §
68-29-138
who are exempt from requirements to be licensed as a technologist, technician,
laboratory trainee, or special analyst.
(15) Examination. Refers to national
certification exams or other exams approved by the Board.
(16) Full Time Work Experience. A minimum of
thirty (30) hours per week or one thousand five hundred sixty (1,560) hours per
year.
(17) Internationally Trained.
Having graduated from a degree program and/or a laboratory training program
outside of the United States or its territories.
(18) License. Document issued to an applicant
who successfully completes the licensure process. The license takes the form of
an "artistically designed" license as well as other versions bearing an
expiration date.
(19) Licensee. Any
person duly licensed by the Board to engage in the practice of laboratory
medicine.
(20) May.
Discretionary.
(21) Medical
Laboratory. Any institution, building, or place in which operations and
procedures for the microbiological, chemical, hematological,
immunohematological, immunological, molecular, cytological, pharmacological,
pharmacogenetical 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.
(22) Medical Laboratory Director. A person
who is responsible for the administration of the technical and scientific
operation of a medical laboratory, including supervision of procedures for
testing and the reporting of results.
(23) Medical Laboratory Personnel.
Individuals licensed by this board, including the medical laboratory director,
supervisor, technologist, technician, or special analyst, but not including
medical laboratory assistants, trainees or other persons employed by a medical
laboratory to perform clerical or other administrative responsibilities
involving no laboratory testing.
(24) Medical Laboratory Supervisor. A person
who under the general supervision of a medical laboratory director, supervises
technical personnel, performs tests requiring special scientific skills, and,
in the absence of the director, is held responsible for the proper performance
of all medical laboratory procedures and the reporting of results.
(25) Medical Laboratory Technician. A person
other than the medical laboratory director, supervisor, technologist, or
trainee who functions under the supervision of a medical laboratory director,
supervisor, or technologist and performs medical laboratory procedures in which
the technician is qualified by education, training, and experience.
(26) Medical Laboratory Technologist. A
person who performs tests which require the exercise of independent judgment
and responsibility with minimal supervision by the director or supervisor, in
only those specialties or subspecialties in which the technologist is qualified
by education, training, and experience.
(27) Medical Laboratory Trainee. A person who
is enrolled in a medical laboratory approved training program seeking
experience required to meet minimum qualifications for a license in the state.
Trainees may perform procedures only under direct, responsible supervision of a
duly licensed director, supervisor, technologist, or special analyst. Trainees
shall only be employed within the laboratory where training is
received.
(28) Moderate/High
Complexity. A clinical laboratory test category assigned by CLIA-88 based on
the test characteristics. See
42 CFR §
493.17.
(29) National Accrediting Agency for Clinical
Laboratory Sciences (NAACLS). Accreditation agency that accredits laboratory
training programs.
(30) Person. Any
individual, firm, partnership, association, corporation, municipality,
political subdivision, or any other entity whether organized for profit or
not.
(31) Physician. Any doctor of
medicine or doctor of osteopathy duly licensed to practice such doctor's
profession in Tennessee.
(32) Point
of Care Laboratory Testing. Laboratory testing performed by health care
personnel/professionals not licensed by the Medical Laboratory Act, T.C.A.
§§
68-29-101,
et seq., and performed outside the duly licensed laboratory and under the
auspices of a laboratory required to be licensed by the Department, pursuant to
the Medical Laboratory Act.
(33)
Regionally Accredited College/University. An institution of higher education
accredited by one of the following United States Associations of Colleges and
Schools: Middle States, Northwest, North Central, New England, Southern or
Western.
(34) Shall.
Mandatory.
(35) Special Analyst.
Any person performing a singular or limited type of medical laboratory test or
group of tests, such as, but not limited to, Andrology, Embryology, Cytology,
Molecular Diagnostics, Cytogenetics, Toxicology, Flow Cytometry, Virology,
Histocompatability/Immunogenetics, on human specimens but who is not trained to
perform the broad range of tests required of licensed medical laboratory
personnel.
(36) Trainee Permit. A
permit that is issued to a trainee that is valid during the training period
provided that the facility where the training is being gained is approved for
practice training. The trainee permit shall be onsite at the training facility
during the student rotation.
(37)
Waived Laboratory Tests. Those tests, as defined by the Board, which may be
performed by individuals not licensed under the Medical Laboratory Act, and
which pose no reasonable risk of harm if performed incorrectly.
Notes
Authority: T.C.A. §§ 4-5-202, 4-5-204, 68-29-103, 68-29-105, 68-29-116, 68-29-117, 68-29-119, 68-29120, and 68-29-134.
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