1. (1) A personnel record for each staff member of a Facility shall include an application for employment and/or resume and a record of any disciplinary action taken. A licensee shall maintain written records for each employee and each individual file shall include:

   1. (a) Identifying information including name, current address, current telephone number, and emergency contact person(s);
   2. (b) A ten (10)-year employment history or a complete employment history if the person has not worked in ten (10) years;
   3. (c) Records of educational qualifications, if applicable;
   4. (d) Date of employment; OPIOD TREATMENT PROGRAM FACILITIES
   5. (e) Documentation of training and orientation of the person’s duties and responsibilities;
   6. (f) Any records relevant to the employee’s performance;
   7. (g) Evidence that any professional license required as a condition of employment is current and in good standing;
   8. (h) Annual verification of basic skills and annual evaluation of personnel performance. Included shall be written verification that the employee has reviewed the evaluation and has had an opportunity to comment on it; and
   9. (i) Training and development activities designed to educate the staff in meeting the needs of the service recipients being served, including STI/HIV education.

2. (2) Tuberculosis.

   1. (a) All new employees, including volunteers who have routine contact with service recipients, shall be tested within three (3) business days of employment for latent tuberculosis infection utilizing the two-step Mantoux method or a single interferon- gamma release blood assay (IGRA).
   2. (b) Employees shall have a test for tuberculosis annually and at the time of exposure to active tuberculosis and three (3) months after exposure. Annual tuberculosis testing of previously TST-negative employees and volunteers shall be performed by the one-step Mantoux method.
   3. (c) Employee records shall include the date and type of annual tuberculin tests given to the employee, date of tuberculin test results, and, if applicable, date and results of chest x-ray and any drug treatment for tuberculosis.

3. (3) Staffing.

   1. (a) Program Director. The governing body of each Facility shall designate in writing a program director who is responsible for the operation of the Facility and overall compliance with federal, state, and local laws and regulations regarding the operation of opioid treatment programs, and for all employees including practitioners, agents, or other persons providing services at the Facility. Facilities shall notify the SOTA in writing within ten (10) calendar days whenever there is a change in program director.
   2. (b) Medical Director. The governing body of each Facility shall designate in writing a medical director to be responsible for the administration of all medical services, including compliance with all federal, state, and local laws and regulations regarding the medical treatment of opioid use disorder. No physician may serve as medical director of more than two (2) Facilities without the prior written approval of the SOTA. The medical director shall be physically present, or available for telehealth services and consultation, at the Facility the equivalent of twenty-five percent (25%) of the time the Facility is open to the public each month. Facilities shall notify the SOTA in writing within ten (10) calendar days whenever a temporary absence of the medical director may cause non-compliance with this staffing requirement, or whenever there is a change in medical director.
   3. (c) Program Physician. Facilities are required to provide sufficient physician services to provide the medical treatment and oversight necessary to serve service recipient needs. Program physician services include, but are not limited to, performing medical history and physical exams, determining a diagnosis under current DSM criteria, OPIOD TREATMENT PROGRAM FACILITIES determination of opioid use disorder, ordering take-home privileges, discussing cases with the treatment team, and issuing any emergency orders.
   4. (d) Physician Assistants and Advanced Practice Nurses. Licensed physician assistants and advanced practice nurses with a certificate of fitness with privileges to write and sign prescriptions and/or issue legend drugs may perform any functions under Tennessee law or regulations.
   5. (e) Program Providers. The Facility shall provide on-site program provider services at least one (1) hour per week for every thirty-five (35) service recipients.
   6. (f) Nurses. Facilities shall ensure that adequate nursing care is provided at all times the Facility is in operation and that a nurse is present at all times when medication is administered at the Facility. Facilities that do not employ a registered nurse to supervise the nursing staff shall ensure that licensed practical nurses adhere to written protocols and are properly supervised consistent with Division 1000-02 Rules and Regulations of Licensed Practical Nurses.
   7. (g) Qualified Counseling Providers. There shall be sufficient group and individual counseling available to meet the requirements pursuant to Rule 0940-05-42-.14.
   8. (h) Pharmacists. The Facility is encouraged to incorporate pharmacist-provided services in the Facility, including providing medication education, overseeing medication procurement and administration, being involved in the development of the Facility’s policies and procedures regarding the use of medications, and be available for consultation for Facility staff and patients.

4. (4) Staff Qualifications.

   1. (a) Medical Director. All medical directors shall be licensed to practice medicine or osteopathy in Tennessee, shall maintain their licenses in good standing, and shall have the following experience and/or credentials:

      1. 1. Three (3) years of documented experience in the provision of services to persons with a substance use disorder, including the treatment of opioid use disorder;
      2. 2. Board eligibility in psychiatry and two (2) years of documented experience in the treatment of persons with a substance use disorder, including the treatment of opioid use disorder; or
      3. 3. Certification or actively engaged in a recognized course of study or another formal process for pursuing certification as an addiction medicine specialist and two (2) years of documented experience in the treatment of persons with a substance use disorder, including the treatment of opioid use disorder.

   2. (b) Waiver from Medical Director Qualifications. Facilities that are unable to secure the services of a medical director who meets the requirements of subparagraph (a) above may apply to the TDMHSAS Office of Licensure for a waiver. The TDMHSAS Office of Licensure, in consultation with the SOTA, may grant such a waiver when there is showing that:

      1. 1. The Facility has made good faith efforts to secure a qualified medical director;
      2. 2. The Facility can secure the services of a licensed physician who is willing to serve as medical director and participate in the training plan; OPIOD TREATMENT PROGRAM FACILITIES
      3. 3. A training plan has been developed which is acceptable to the SOTA and which consists of a combination of continuing education in addiction medicine and in- service training by a medical consultant who meets the qualifications specified in subparagraph (a) above; and
      4. 4. A medical consultant who meets the requirements of subparagraph (a) above shall be available, consistent with a training plan approved by the SOTA, to oversee the training of the medical director and the delivery of medical services at the Facility requesting the waiver.
   3. (c) Program Provider. All program providers shall be licensed to practice in Tennessee, shall maintain their licenses in good standing, and shall have at least one (1) year of documented experience in the treatment of persons with a substance use disorder.

   4. (d) Waiver from Program Provider Qualifications. Facilities seeking to employ a program provider, in addition to the medical director, but are unable to secure the services of a program provider who meets the requirements of subparagraph (c) above may apply to the TDMHSAS Office of Licensure for a waiver. The TDMHSAS Office of Licensure, in consultation with the SOTA, may grant such a waiver when there is a showing that:

      1. 1. The Facility has made good faith efforts to secure a qualified program physician;
      2. 2. The Facility can secure the services of a licensed physician who is willing to serve as program physician and participate in the training plan;
      3. 3. A training plan has been developed which is acceptable to the SOTA and which consists of a combination of continuing education in addiction medicine and in- service training by the Facility’s medical director; and
      4. 4. The Facility employs a qualified medical director who has the experience and credentials specified in subparagraph (a) above, has completed the training program specified in subparagraph (b) above or has completed the continuing education specified in subparagraph (f) below.
   5. (e) Nurses. All registered nurses and licensed practical nurses shall be licensed to practice in Tennessee and shall maintain their license in good standing.

   6. (f) Qualified Counseling Providers. All qualified counseling providers shall:

      1. 1. Meet one (1) of the following conditions; and

   7. (i) Licensed by the State of Tennessee as one (1) of the following (with experience or supervision as described, where specified): or

      1. (I) Alcohol and Drug Abuse Counselor I or II (commonly referred to as LADAC I or LADAC II);
      2. (II) Psychologist;

      3. (III) Psychological examiner;

         1. (IV) Physician with experience or training in counseling;
         2. (V) Physician assistant with experience or training in counseling; OPIOD TREATMENT PROGRAM FACILITIES
         3. (VI) Registered nurse with experience or training in counseling;

      4. (VII) Social worker meeting one of the following;

         1. I. If licensed as a bachelor’s-level social worker (LBSW) with training in counseling and direct supervision by a master’s- level social worker (LCSW or LMSW); II. Licensed as a master’s-level social worker (LMSW); or III. Licensed as a clinical social worker (LCSW).

            1. (VIII) Professional Counselor; or

               1. (IX) Marriage and Family Therapist.

            2. (ii) Actively engaged in a recognized course of study or another formal process for pursuing licensure of a discipline described in subpart (i) above. Supervision shall be in accordance with the respective laws, rules, and regulations governing the professional licensure pursued.

               1. 2. Be qualified by education and/or experience for the specific duties of their position and only perform those duties within the scope of their applicable professional practice acts and Tennessee license.
            3. (g) Pharmacist. All pharmacists shall be licensed to practice in Tennessee and shall maintain their license in good standing.
            4. (h) Program Directors. All Facility program directors shall have at least one (1) year of supervisory or administrative experience in the field of mental health or substance use disorder treatment, or a minimum of six (6) months of experience with approval from the SOTA.
            5. (i) Professional Practice. All professional staff, including, but not limited to, physicians, physician assistants, nurses, pharmacists, and counselors, may perform only those duties that are within the scope of their applicable professional practice acts and Tennessee licenses.

            6. (5) Staff Training and Orientation. Prior to working with service recipients, all staff providing treatment or services shall be oriented in accordance with these rules and shall thereafter receive additional training with these rules.

               1. (a) Orientation shall include instruction in:

                  1. 1. The Facility’s written policies and procedures regarding its purposes and description; service recipient rights, responsibilities, and complaints; confidentiality; and other policies and procedures that are relevant to the employee’s range of duties and responsibilities;
                  2. 2. The employee’s assigned duties and responsibilities; and
                  3. 3. Reporting service recipient progress and problems to supervisory personnel and procedures for handling medical emergencies or other incidents that affect the delivery of treatment or services. OPIOD TREATMENT PROGRAM FACILITIES

               2. (b) Additional training consisting of a minimum of eight (8) hours of training or instruction shall be provided annually for each staff member who provides treatment or services to service recipients. Such training shall be in subjects that relate to the employee’s assigned duties and responsibilities, and in subjects about current clinical practice guidelines for medication-assisted treatment. In-house training for staff may be substituted for external training with the approval of the SOTA. The following areas shall receive emphasis during training:

                  1. 1. Dosage level as determined through a provider’s clinical decision-making and the individual service recipient’s needs;
                  2. 2. Counseling;
                  3. 3. Drug screens;
                  4. 4. Treatment stability;
                  5. 5. Treating multiple substance use disorders;
                  6. 6. Opioid treatment during pregnancy and chronic diseases;
                  7. 7. HIV and other infectious diseases;
                  8. 8. Co-morbid psychiatric conditions;
                  9. 9. FDA-approved drugs for the treatment of opioid use disorder;
                  10. 10. Take-home medication practices;
                  11. 11. Chronic pain and pain management; and
                  12. 12. Referring service recipients for primary care or other specialized services.
               3. (c) The SOTA may require Facilities to attend mandatory training in addition to any other training required by these rules.
               4. (d) Facilities shall maintain records documenting that each staff member has received the required annual training.
            7. (6) Employee Drug Screening. Facilities shall establish and implement written policies and procedures for pre-employment and ongoing random drug screening of all Facility employees. Each sample collected shall be screened for opioids, methadone, amphetamines, cocaine, benzodiazepines, and other drugs as indicated by the SOTA.
            8. (7) A minimum of one (1) on-duty staff member certified in cardiopulmonary resuscitation (CPR) and trained in the Abdominal Thrust Technique and First Aid shall be maintained.

Authority: T.C.A. §§ 4-3-1601, 4-4-103, 33-1-302, 33-1-305, 33-1-309, 33-2-301, 33-2-302, and 33-2- 404. Administrative History: Original rule filed September 20, 2012; effective December 19, 2012. Amendments filed June 6, 2025; effective September 4, 2025. OPIOD TREATMENT PROGRAM FACILITIES