Section 0940-05-42-.21 - REPORTING REQUIREMENTS(1) The Facility shall submit the following information to the department: (a) All reports, forms and correspondence submitted to or received from the FDA, DEA, any other applicable federal agencies or accreditation organizations shall be provided to the SOTA within five business days of sending or receiving such documents.(b) Such reports and information which may be required by the department to conduct evaluations of opioid replacement treatment effectiveness or monitor service delivery.(2) The OTP shall report each case of communicable disease to the local county health officer in the manner provided by T.C.A. § 68-5-102 and Chapter 1200-14 of the Rules of the Tennessee Department of Health. Repeated failure to report communicable diseases shall be cause for revocation of a Facility license.(3) The Facility shall report within 24 hours to the Office of Licensure and the SOTA the abuse of a service recipient or an unexpected occurrence or accident that results in death or serious injury to a service recipient or any action taken against the Facility by the DEA, accrediting body or other state, local or federal agency. Additionally, the following are examples of events that should be reported: (a) Medication errors that caused or had the potential to cause harm to the service recipient;(c) Suicide or attempted suicide;(e) Neglect of a service recipient;(f) Service recipient altercations;(g) Service recipient abuse;(h) Misappropriation of service recipient funds; (i) Restraint related incidents; or (j) Poisoning occurring within the Facility.(4) Specific incidents that might result in a disruption of the delivery of health care services at the Facility shall be reported to the Office of Licensure and the SOTA within seven days after the Facility learns of the incident. These specific incidents include the following:(a) Strike by the staff at the Facility;(b) External disaster impacting the Facility;(c) Disruption of any service vital to the continuous, safe operation of the Facility or to the health and safety of its service recipients and personnel;(d) Fires at the Facility which disrupt the provision of service recipient care services or cause harm to service recipients or staff, or which are reported by the Facility to any entity, including, but not limited to, a fire department charged with preventing fires; and(e) Improper disclosure of a service recipient's protected health information.(5) Within seven days of any event described in (3), the Facility shall file a report with the Office of Licensure and the SOTA on the incident consisting of the following: (a) The actions implemented to prevent the reoccurrence 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. 0940-05-42-.21
Original rule filed September 20, 2012; effective December 19, 2012.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.