Section 1200-06-02-.07 - MEDICAL LABORATORY SPECIAL ANALYST PROGRAM MINIMUM REQUIREMENTS(1) Special Analyst Programs (a) Molecular Diagnostics Training Program 1. Medical Director (i) The medical director shall be a physician who is certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or who possesses qualifications which are equivalent to those required for such certification (Board eligible).(ii) The medical director shall be licensed to practice medicine in Tennessee.(iii) The medical director shall meet one of the minimum qualifications of Medical Laboratory Director, as set forth in Rule 1200-06-01-.20. The program he or she directs must be related to his or her training.2. Program Director(i) The program must have a qualified program director.(ii) The program director must be a medical laboratory professional who: (I) Has an earned master's or doctoral degree;(II) Holds nationally recognized certification. (The certification examination must be accredited and require a bachelor's degree for eligibility.) If the program director is not certified in the same discipline as the program, a qualified professional who holds nationally recognized certification in the program discipline must be appointed as Education Coordinator;(III) Regularly engages in continuing professional education as documented by the certification maintenance program or other sources;(IV) Has three years of teaching experience; and(V) Has knowledge of education methods and administration as well as current NAACLS, or other board approved agency accreditation procedures.(iii) The program director must: (I) Be responsible for the organization, administration, instruction, evaluation, continuous quality improvement, curriculum planning and development, directing other program faculty/staff, and general effectiveness of the program;(II) Provide evidence that he or she participates in the budget preparation process;(III) Be responsible for maintaining NAACLS, or other board approved agency accreditation; and(IV) Have regular and consistent contact with students, faculty, and program personnel.3. Education Coordinator (when required) (i) The Education Coordinator must be a medical laboratory professional who:(I) Has at least a baccalaureate degree and three years of experience in the program discipline;(II) Holds nationally recognized certification in the program discipline, e.g., MB(ASCP)CM;(III) Has completed thirty-six hours of professional continuing education within the past three years;(IV) Has three years of experience in medical laboratory science education; and(V) Has knowledge of education methods and administration as well as current NAACLS, or other board approved agency accreditation procedures.(ii) The Education Coordinator must provide supervision and coordination of the instructional faculty in the academic and clinical phases of the education program.4. On-site Program Coordinator (when required, one at each participating entity in a consortium or joint venture) (i) The on-site program coordinator must: (I) Have an academic degree appropriate to the program level;(II) Hold an appropriate nationally recognized certification required of a program director; and(III) Have at least one year of experience in medical laboratory science education.(ii) The on-site program coordinator, when required, is responsible for:(I) Coordinating teaching and clinical education;(II) Evaluating program effectiveness; and(III) Maintaining appropriate communications with the program director.5. Didactic Instructor (i) The program must have qualified faculty/instructors who hold appointments within the educational program (e.g., certified professionals in their respective or related fields). The program must ensure and document ongoing professional development of the program faculty/instructors.(ii) Faculty/instructors designated by the program must: (I) Demonstrate adequate knowledge and proficiency in their content areas and(II) Demonstrate the ability to teach effectively at the appropriate level.(iii) The responsibilities of the faculty/instructors must include:(I) Participation in teaching courses;(II) Evaluation of student achievement;(III) Development of curriculum, policy and procedures; and(IV) Assessment of program outcomes.6. Clinical Coordinator(i) At least one clinical coordinator must be designated at each clinical site affiliated with the program to provide clinical experience to students.(ii) The Clinical Coordinator must: (I) Be a medical laboratory professional who holds nationally recognized certification and professional licensure in the program discipline;(II) Demonstrate proficiency in and adequate knowledge of the program discipline;(III) Have at least one year experience as a practicing professional in the program discipline; and(IV) Demonstrate ability to teach clinical skills/content effectively at the appropriate level.(iii) The Clinical Coordinator must be responsible for:(I) Coordinating and ensuring effectiveness of clinical instruction at the site;(II) Evaluating effectiveness of clinical instruction;(III) Monitoring and evaluating students' clinical performance; and(IV) Maintaining effective communication with the program director.7. Advisory Committee (i) There must be an advisory committee composed of individuals from the community of interest (e.g. practicing professionals, academic professionals, scientific consultants, administrators, pathologists and other physicians, and public members) who have knowledge of clinical laboratory science education.(ii) The advisory committee of the program shall have input into the program/curriculum to maintain current relevancy and effectiveness.8. Instructional Areas(i) Prerequisite courses in biology including genetics, chemistry and mathematics that provide the foundation for course work required in the laboratory science program.(ii) The curriculum must address pre-analytical, analytical and post-analytical components of diagnostic molecular laboratory services covering diagnostic molecular tests used to detect or diagnose acquired (infectious and non-infectious) diseases and genetic predisposition or disorders. This includes principles and methodologies, performance of assays, problemsolving, troubleshooting techniques, interpretation and evaluation of clinical procedures and results, statistical approaches to data evaluation, principles and practices of quality assurance/quality improvement, and continuous assessment of laboratory services.(iii) The program curriculum must include the following scientific content: (I) Organic and/or biochemistry, genetics, cell biology, microbiology, immunology, and diagnostic molecular biology;(II) Principles, methodologies, and applications of molecular microbiology (infectious diseases), molecular pathology (hematology/oncology), and molecular genetics. Techniques of molecular science must include current techniques in each of the following areas: separation and detection, amplification, and sequence analysis;(III) Clinical significance of laboratory procedures in diagnosis and treatment;(IV) Application of safety and governmental regulations and standards as applied to diagnostic molecular science;(V) Principles and practices of professional conduct and the significance of continuing professional development;(VI) Communications sufficient to serve the needs of patients, the public and members of the health care team;(VII) Principles and practices of administration, supervision, and quality management as applied to diagnostic molecular science;(VIII) Evaluation of laboratory information systems;(IX) Educational methodologies and terminology sufficient to train/educate users and providers of laboratory services; and(X) Principles and practices of applied study design, implementation and dissemination of results.9. Institutional Requirements(i) A specialty program may be conducted in one of the following ways: (I) An integrated program in an accredited college or university that will culminate in at least a baccalaureate degree in one of the medical laboratory specialties.(II) A one year program for students (trainees) who already possess a baccalaureate degree in a chemical, physical or biological science. The program shall consist of appropriate didactic classroom instruction. The remainder of the year shall be spent in gaining meaningful clinical laboratory experience in the applicable specialty.(b) Cytogenetic Technology Training Program 1. Medical Director (i) The medical director shall be a physician who is certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or who possesses qualifications which are equivalent to those required for such certification (Board eligible).(ii) The medical director shall be licensed to practice medicine in Tennessee.(iii) The medical director shall meet one of the minimum qualifications of Medical Laboratory Director, as set forth in Rule 1200-06-01-.20. The program he or she directs must be related to his or her training.2. Program Director(i) The program director must be a medical laboratory professional who:(I) Has an earned master's or doctoral degree;(II) Maintains current certification or licensure in cytogenetic technology, medical genetics, or another human genetics area;(III) Regularly engages in continuing professional education as documented by the certification maintenance program or other sources;(IV) Has three years of teaching experience; and(V) Has knowledge of education methods and administration as well as current NAACLS, or other board approved agency accreditation procedures.(ii) The program director must: (I) Be responsible for the organization, administration, instruction, evaluation, continuous quality improvement, curriculum planning and development, directing other program faculty/staff, and general effectiveness of the program;(II) Provide evidence that he or she participates in the budget preparation process;(III) Be responsible for maintaining NAACLS, or other board approved agency accreditation. Training programs licensed prior to June 1, 2014 are not required to obtain or maintain NAACLS accreditation;(IV) Have regular and consistent contact with students, faculty, and program personnel.3. On-site Program Coordinator (required for consortia or multi-location only; one at each participating site)(i) The on-site program coordinator must:(I) Have an academic degree appropriate to the program level;(II) Hold an appropriate nationally recognized certification required of a program director; and(III) Have at least one year of experience in medical laboratory science education.(ii) The on-site program coordinator, when required, is responsible for:(I) Coordinating teaching and clinical education;(II) Evaluating program effectiveness; and(III) Maintaining appropriate communications with the program director.4. Didactic Instructor (i) The program must have qualified faculty/instructors who hold appointments within the educational program (e.g., certified professionals in their respective or related fields). The program must ensure and document ongoing professional development of the program faculty/instructors.(ii) Faculty/instructors designated by the program must: (I) Demonstrate adequate knowledge and proficiency in their content areas and(II) Demonstrate the ability to teach effectively at the appropriate level.(iii) The responsibilities of the faculty/instructors must include:(I) Participation in teaching courses;(II) Evaluation of student achievement;(III) Development of curriculum, policy and procedures; and(IV) Assessment of program outcomes.5. Clinical Coordinator(i) At least one clinical coordinator must be designated at each clinical site affiliated with the program to provide clinical experience to students.(ii) The Clinical Coordinator must: (I) Be a medical laboratory professional who holds nationally recognized certification and professional licensure in the program discipline;(II) Demonstrate proficiency in and adequate knowledge of the program discipline;(III) Have at least one year experience as a practicing professional in the program discipline; and(IV) Demonstrate ability to teach clinical skills/content effectively at the appropriate level.(iii) The Clinical Coordinator must be responsible for:(I) Coordinating and ensuring effectiveness of clinical instruction at the site;(II) Evaluating effectiveness of clinical instruction;(III) Monitoring and evaluating students' clinical performance; and(IV) Maintaining effective communication with the program director.6. Advisory Committee (i) There must be an advisory committee composed of individuals from the community of interest (e.g. practicing professionals, academic professionals, scientific consultants, administrators, pathologists and other physicians, and public members) who have knowledge of clinical laboratory science education.(ii) The advisory committee of the program shall have input into the program/curriculum to maintain current relevancy and effectiveness.7. Instructional Areas(i) Prerequisite content in biology, chemistry and mathematics that provides the foundation for course work required in the laboratory science program.(ii) The program curriculum must include the following scientific content:(I) Specimen Preparation (sample acquisition, transport/storage, preparation, culture, harvest, slide preparation, and staining);(II) Molecular Cytogenetic Testing (utilize appropriate techniques for preparation and analysis of molecular cytogenetic specimens);(III) Chromosome Analysis and Imaging (selection, analysis, and description of suitable metaphase or interphase cells using microscopy and imaging);(IV) Laboratory Operations (general laboratory skills, guidelines/ government regulations, safety, quality assurance/control and professional standards and conduct);(V) Principles of interpersonal and interdisciplinary communication and team-building skills and the significance of continuing professional development;(VI) Principles and practices of administration and supervision;(VII) Educational methodologies and terminology sufficient to train/educate users and providers of laboratory services sufficient for future clinical faculty); and(VIII) Principles and practices of applied study design, implementation and dissemination of results.8. Institutional Requirements (i) A specialty program may be conducted in one of the following ways: (I) An integrated program in an accredited college or university that will culminate in at least a baccalaureate degree in one of the medical laboratory specialties.(II) A one year program for students (trainees) who already possess a baccalaureate degree in a chemical, physical or biological science. The program shall consist of appropriate didactic classroom instruction. The remainder of the year shall be spent in gaining meaningful clinical laboratory experience in the applicable specialty.Tenn. Comp. R. & Regs. 1200-06-02-.07
Original rule filed October 26, 1979; effective December 10, 1979. Repeal and new rule filed January 7, 1997; effective March 23, 1997. Repeal and new rule 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.