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 by the Facility. A licensee shall maintain written records for each employee and volunteer utilized by the Facility.

2. (2) Staffing.

   1. (a) Facility Director. The governing body of each Facility shall designate in writing a Facility 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 nonresidential office-based opiate treatment programs, and for all employees at the Facility. However, non-physician Facility directors shall not supervise medical staff. Facilities shall notify the TDMHSAS Office of Licensure in writing within ten (10) calendar days whenever there is a change in Facility director.
   2. (b) Medical Director. The governing body of each Facility shall designate in writing a medical director to be responsible for the supervision of all medical staff at the Facility and the administration of all medical services at the Facility, including compliance with all federal, state, and local laws and regulations regarding the medical treatment of opioid use disorder. The medical director shall be physically present at the Facility the equivalent of twenty-five (25) percent of the time the Facility is open to the public each week. On a monthly basis, the medical director shall review ten (10) percent of the medical charts for patients currently admitted at the Facility and document each chart review. No physician may serve as medical director of more than three (3) Facilities without the prior written approval of the TDMHSAS Office of Licensure.
   3. (c) Program Physician. Facilities are required to provide sufficient physician services to provide the medical treatment and oversight necessary to serve patient need. A Program Physician may be the same individual as the Medical Director, should the Facility so choose and all qualification requirements for a medical director are still met.
   4. (d) Physician Assistants and Advanced Practice Registered Nurses. Licensed physician assistants and advanced practice registered nurses with a certificate of fitness with privileges to write and sign prescriptions and/or issue legend drugs may perform any functions under federal and Tennessee laws or regulations. Any physician assistants and/or advanced practice registered nurses issuing prescriptions at the Facility shall have their supervising or collaborating physician clearly documented in their personnel file, if applicable. Physician assistants and advanced practice registered nurses shall maintain an unrestricted license with their applicable Health Related Board.

   5. (e) Case Management/Care Coordination. Each Facility shall provide case management/care coordination services by a person who has received appropriate training and education, and:

      1. 1. Who has at least a Bachelor degree or equivalent education; or
      2. 2. Who is supervised by a qualified counseling provider or program provider who has received training and education to provide case management services.

3. (3) Staff Qualifications. OFFICE-BASED OPIATE TREATMENT FACILITIES

   1. (a) Staff Training. Prior to working with patients, all staff with direct patient interaction/responsibility shall be oriented in accordance with all applicable administrative rules (as listed in 0940-05-35-.03), reporting requirements, and their individual position responsibilities. All staff shall receive ongoing training and development activities. Record of all staff training activities shall be noted in their personnel record.

   2. (b) Medical Director. A medical director shall be licensed to practice medicine or osteopathy in Tennessee, shall maintain an unrestricted license to practice medicine or osteopathy, be designated by the OBOT’s governing body, and shall have the following experience and/or credentials:

      1. 1. Certification in addiction psychiatry by the American Board of Psychiatry and Neurology or exam eligible in addiction psychiatry; and two (2) years of documented experience in the treatment of persons who are addicted to alcohol or other drugs; or
      2. 2. Certification as an addiction medicine specialist by the American Board of Addiction Medicine (ABAM) or the American Board of Preventive Medicine (ABPM) or exam eligible for certification as an addiction medicine specialist and two (2) years of documented experience in the treatment of persons who are addicted to alcohol or other drugs; or
      3. 3. Meet the Tennessee Department of Health definition of addiction specialist as outlined in Rule 0880-02-.14; or
      4. 4. For an OBOT that is accredited by a national accrediting healthcare organization listed in Rule 0940-05-02-.12(1)(a) or (b) in a behavioral health or opioid treatment service category, or equivalent, the medical director shall be exempted from the requirements of 1.–3. above.
   3. (c) Program Physician. A program physician shall be licensed to practice medicine or osteopathy in Tennessee, and shall maintain an unrestricted license to practice medicine or osteopathy.
   4. (d) Facility Directors. All Facility directors shall have at least one (1) year of supervisory or administrative experience in the field of opioid use disorder treatment.
   5. (e) Program Provider. A program provider shall be duly licensed, certified or registered as required by the State of Tennessee for the profession and shall only perform those duties that are within the scope of their applicable professional practice acts and Tennessee license.
4. (4) Direct Care Drug Screening. Facilities shall implement drug screenings for all persons providing direct services on behalf of the Facility regardless of whether persons are employed, contracted, or volunteering. Drug screens shall be completed initially, prior to any service provision, and randomly each year thereafter.
5. (5) In addition to the above Personnel and Staffing Requirements, the Facility shall follow the Personnel and Staffing Requirements as detailed in 0940-05-06.

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, 33-2-402, 33-2-403, 33-2-404, and 33-2-407. Administrative History: Original rules filed October 14, 2016; effective January 12, 2017. Rule was previously numbered 0940-05-35-.19 but was renumbered 0940-05- OFFICE-BASED OPIATE TREATMENT FACILITIES 35-.20 with the introduction of a new rule 0940-05-35-.10 filed March 29, 2019; effective June 27, 2019. Amendments filed March 29, 2019; effective June 27, 2019. Amendments filed June 27, 2025; effective September 25, 2025.