Tenn. Comp. R. & Regs. 0940-05-36-.06 - RECORDKEEPING

(1) Each OBOT Plus shall maintain records with the following information for each buprenorphine product dispensed:

(a) Name of product;

(b) Medication strength;

(c) Dosage form;

(d) Date dispensed;

(e) Adequate identification of patient;

(f) Amount dispensed; and

(g) Dispenser's initials or other identifier.

(2) OBOT Plus facilities must maintain documentation of participation in the Central Registry, pursuant to Rule 0940-05-36-.11, in order to prevent dual enrollment, diversion and to ensure patient safety.

(3) OBOT Plus facilities must report all medications dispensed to the controlled substances monitoring database, as defined in Rule 0940-05-35-.02(2)(d), to the extent permitted by 42 C.F.R. Part 2.

(4) A patient record system shall be maintained by all OBOT Plus facilities for patients for whom prescription or medical orders are dispensed. The patient record system shall provide for the immediate retrieval of information necessary to identify previously dispensed prescription or medical orders at the time a prescription or medical order is presented.

(a) In the event of a patient record system shut down, dispensing records must be maintained manually and entered into the patient records system as soon as the issue causing the shutdown is resolved.

(5) A record of compliance with Rule 0940-05-36-.09 shall be signed by the Facility Director and maintained at the OBOT Plus facility with other controlled substance records for at least two (2) years.

(6) Authorized providers shall notify their appropriate licensing board of their intent to dispense buprenorphine at an OBOT Plus facility. OBOT Plus facilities shall be required to maintain records indicating this notification for each authorized provider it employs for as long as he/she is employed and at least one (1) year thereafter.

(7) The required recordkeeping of this section will be maintained in a dispensing log at the physical location of the OBOT Plus facility.

Notes

Tenn. Comp. R. & Regs. 0940-05-36-.06

Original rules filed March 29, 2019; effective 6/27/2019.

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, 33-2-407, and Chapter 978 of the Public Acts of 2018.