Section 0940-05-35-.17 - REPORTING REQUIREMENTS(1) Upon request or inspection, the Facility shall submit the following information to the Department:(a) All reports, forms, and correspondence submitted to or received from the health-related boards of the Tennessee Department of Health, FDA, DEA, SAMHSA or any other applicable federal agencies, or accreditation organizations shall be provided to the Office of Licensure within five (5) business days of sending or receiving such documents.(b) Such reports and information which may be required by the Department to conduct evaluations of medication assisted treatment effectiveness or monitor service delivery.(2) The Facility shall report any significant occurrence, as defined in the TDMHSAS Office of Licensure Reportable Incident Form Instructions, to the Office of Licensure. This shall include any unexpected occurrence or accident that results in death or serious injury to a patient or any action taken against the Facility by the DEA, accrediting body, or other state (not to exclude any state related boards and/or commissions), local, or federal agency. Additional reporting requirements may be found in Chapter 0940-05-02-.20.(3) The Facility shall be required to respond in writing following the citation of the Office of Licensure or other State entity. The Facility will be given an appropriate amount of time to respond and their response should encapsulate at least the following: (a) The actions implemented to prevent the recurrence of the event;(b) The time frames for the action(s) to be implemented;(c) The person(s) designated to implement and monitor the action(s); and(d) The strategies for the measurements of effectiveness to be established.Tenn. Comp. R. & Regs. 0940-05-35-.17
Original rules filed October 14, 2016; effective January 12, 2017. Rule was previously numbered 0940-05-35-.16 but was renumbered 0940-05-35-.17 with the introduction of a new rule 0940-05-35-.10 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 912 of the Public Acts of 2016.