Tenn. Comp. R. & Regs. 1200-06-02-.01 - GENERAL REQUIREMENTS FOR ALL PROGRAMS

(1) The Board shall approve the training programs which meet the requirements of one of the following types:

(a) Medical Laboratory Technologist Program

(b) Medical Laboratory Technician - Associate Degree Program

(c) Medical Laboratory Technologist Specialty Program

(d) Special Analyst Program

(2) All Programs for the Training of Medical Laboratory Personnel to Apply for Approval.

(a) The owner and/or the director of a training program for medical laboratory personnel shall make application for approval to operate that program on forms provided by the Board at least six (6) months prior to anticipated first day of instruction.

(b) Each school shall be subject to on-site inspection by representatives of the Board and/or complete such paper surveys as requested.

(c) A scheduled on-site inspection to validate the initial application shall be conducted by representatives of the Board.

(d) The Board shall be notified within thirty (30) days of any changes made in the operation of the training program such as a change of ownership, location, accreditation status, directorship, instructors and/or program closure. A new certificate of approval will be issued in the event of change in either ownership or directorship of the training program. A change in ownership shall also include an exchange of stock in an incorporated school.

(e) All training programs must be accredited by a national organization approved by the Board, if applicable.

(3) Fees Amount

(a)

Initial Training Program Application Fee	$200.00
Annual Registration (Renewal) Fee	$100.00
State Regulatory Fee	$5.00

(b) The Certificate of Approval shall be for one (1) year and shall expire on December 31st of any given year.

(4) Minimum Standards for Facilities, Equipment, and Materials for All Training Programs for Medical Laboratory Personnel.

(a) The Training Program must insure that adequate space, light, and modern operable equipment is available in the teaching laboratory and medical laboratory's clinical rotation sites. All equipment used in the training program shall be subject to inspection and approval by the Board.

(b) Each training program for medical laboratory personnel shall have adequate classroom, laboratory, office, storage, and sanitary facilities which shall be subject to inspection and approval by the Board.

(c) A designated student laboratory area shall be available for teaching basic techniques, instrumentation and problem solving for procedures not available in the clinical facility(ies).

(d) Each training program facility for medical laboratory personnel must provide written documentation of compliance with local and state fire codes to the Board upon request.

(e) Written fire and safety procedures shall be made available to each student. Pertinent fire safety procedures shall be displayed in conspicuous places in the training program facility.

(f) A library containing up-to-date texts, references, and scientific periodicals pertinent to laboratory medicine as well as the latest editions of books and journals on laboratory technology shall be accessible to the students. Texts required to be purchased by students must not be a substitute library [Older reference texts of value may be retained. Up-to-date is defined as published within the last five (5) years].

(g) Demonstration materials and multimedia instructional material shall be available as provided under other sections of these regulations.

(h) An outline of the instruction provided, including a structured clinical laboratory practicum, shall be filed with the Board. When major revisions/changes are made in the curriculum, a new outline shall be submitted to the Board.

(i) A description of evaluation procedures for both student and program shall be submitted to the Board upon making application for approval of the Training Program. These evaluations shall be maintained for future inspection by the Board or its designee. Provision must be included for periodic review of the effectiveness of the program by members of the faculty and/or other appropriate groups. Student evaluation procedures must include mechanisms to measure cognitive knowledge, psychomotor and affective behavior.

(j) Student recruitment, admission and matriculation must be nondiscriminatory with respect to color, creed, race, sex, age, handicap(s), and national origin.

(k) Satisfactory records must be kept and shall be available for inspection by the Board. These shall include but not be limited to:

1. A list of instructors, by category, in the training program and clinical laboratory facilities. This list shall be submitted with initial application and thereafter upon request;

2. Current examinations given to students;

3. Scores on licensure examinations;

4. Records of students, including:

(i) A complete application form;

(ii) Transcript of academic credit;

(iii) Written evidence the student can reasonably be expected to perform the medical laboratory work for which he/she is trained which must include a recent complete physical examination performed by a licensed physician or nurse practitioner prior to beginning clinical rotation;

(iv) Record of attendance, including excused and unexcused absences;

(v) Evaluation by instructors based on appropriate written, practical, and oral examinations covering all types of structured learning experiences (clinical and classroom) related to the medical laboratory; and

(vi) Written criteria for passing, failing, and progression in the program must be provided. These must be given to each student at the time of entry into the program and may be provided either electronically or by hard copy.

(l) The program shall be approved for a specific number of students which shall not be exceeded without prior approval by the Board.

(m) There shall be an affiliation agreement between the educational institution and the licensed laboratory agreeing to serve as the clinical rotation site. The agreement shall state the responsibilities of each party regarding the clinical training of the students enrolled in that program and instructions from each clinical facility for exchange of information and views. The affiliation agreement shall be submitted to the Board upon initial application for training program approval and thereafter prior to any change in clinical rotation sites. A clinical rotation fact sheet must accompany the affiliation agreement for each rotation site.

(n) Each student must have access to and experience with contemporary computer technology.

(5) Clinical Facilities and Approved Laboratory Experience - Practicum (bench training).

(a) Programs for the training of medical laboratory personnel shall be approved only when they are affiliated with a hospital(s) or a medical laboratory(ies) for clinical experience (practicum). The training program may be affiliated with in-state licensed laboratories or out-of-state CLIA certified laboratories. The clinical facility(ies) shall be approved in advance by the Board.

(b) Clinical facilities with a balanced distribution of clinical laboratory material shall meet the following minimum standards in order to train students:

1. The medical laboratory training program Director and/or Education Coordinator must assume responsibility for arranging the approved clinical laboratory experience (practicum) for the student with an affiliated facility(ies). It shall be a violation of these regulations to grant a diploma to any student who has not completed an approved clinical laboratory experience (practicum).

2. Trainee applications shall be submitted for each student prior to the beginning of the approved clinical laboratory experience (practicum). The Board will then issue a trainee permit to the applicant provided they are in an approved facility. No student shall perform laboratory tests without a valid trainee permit.

(6) The Use of Students as Substitutes for Licensed Medical Laboratory Personnel. No training program substituting students (trainees) for licensed medical laboratory personnel shall be approved. Using students (trainees) to perform laboratory procedures without adequate supervision shall result in withdrawal of training program approval and shall subject the training program to disciplinary action as provided for in the Tennessee Medical Laboratory Act.

(7) Copies of the Law and Regulations to Be Made Available to the Students. A copy of the Tennessee Medical Laboratory Act and the regulations promulgated thereunder shall be made available to each student in either an electronic format or a hard copy format.

(8) Training Programs for Medical Laboratory Technologists and Technicians to Be Separate. Training Programs for the training of medical technologists and technicians shall be separate and distinct, and students in each class should have separate instruction in the classroom and in the clinical facility(ies).

(9) Penalty for Making Misrepresentations to Prospective Students. Any owner, director, personnel, or agent of a school for the training of medical laboratory personnel who misrepresents facts concerning the facility(ies), student training, or any other facet of the school to prospective students shall be subject to withdrawal of approval of said school. This shall include but not be limited to:

(a) Announcements and advertising must accurately reflect the program offered.

(b) Student recruitment and academic policies shall be non-discriminatory with respect to race, color, creed, sex, age, handicap(s), and national origin.

(c) Academic credit and costs to the student shall be accurately stated, published and made known to all applicants.

(d) Policies and procedures for student withdrawal and refunds of tuition and fees shall be published and made known to all applicants upon admission.

(e) If more than one level of medical laboratory educational program is offered at one institution, e.g., Medical Technology and Medical Laboratory Technician, the institution must demonstrate that each program is being conducted to assure appropriate instruction for the students at the different educational levels.

(f) The program must culminate in an associate degree or higher. The granting of the degree must not be contingent upon the student's passing any type of external certification or licensure examination.

(g) In the event that the program is discontinued or restructured, the program should provide a plan for the protection of its students accepted or enrolled in the program.

(10) Curricular Structure. The applied courses must be taught in a clinically equipped teaching laboratory on the college campus, in an affiliated clinical facility, or in both facilities sufficient for developing basic skills, understanding principles, and mastering the procedures.

Notes

Tenn. Comp. R. & Regs. 1200-06-02-.01

Original rule filed October 26, 1979; effective December 10, 1979. Amendment filed June 30, 1987; effective August 14, 1987. Amendment filed July 13, 1990; effective August 27, 1990. Amendment filed February 21, 1991; effective April 7, 1991. Repeal and new rule filed January 7, 1997; effective March 23, 1997. Amendments filed October 3, 2014; effective January 1, 2015. Amendments filed January 13, 2022; effective 4/13/2022.

Authority: T.C.A. §§ 4-5-202, 4-5-204, 68-29-105, and 68-29-110.