1. (1) Facilities that plan to operate a mobile unit must also comply with Title 21 of the C.F.R. Parts 1300, 1301, and 1304.

2. (2) Procedure for Initiation of Mobile Unit Services.

   1. (a) The Facility shall provide written notification of intent to provide mobile unit services to the SOTA and the Office of Licensure along with a Certificate of Need (CON), if required by the Tennessee Health Facilities Commission or any other applicable state agency. The OTP must receive written approval from the SOTA and Office of Licensure prior to providing services via the mobile unit.
   2. (b) At a minimum of thirty (30) days prior to operating the mobile unit, a schedule of locations where the unit will provide services shall be submitted to the SOTA.
   3. (c) The SOTA shall be notified of changes to the declared scheduled fourteen (14) days in advance of operating at the alternative locations. Should it be required by the Tennessee Health Facilities Commission (or any other applicable state agency), the appropriate CON for the alternative location shall be provided with the notification of change.

3. (3) Policy and Procedures.

   1. (a) Registration. All required DEA and vehicle registrations shall be maintained at the Facility and available for inspection, upon request.

   2. (b) Operations. The Facility shall develop and implement policies and procedures for the operation of the mobile unit, including but not limited to:

      1. 1. The transfer and use of medications;
      2. 2. Security of the mobile unit and staff;
      3. 3. Staffing;
      4. 4. Downtime procedures and emergencies; and
      5. 5. Regulatory compliance.

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: New rule filed June 6, 2025; effective September 4, 2025.