Authority: IC 16-21-1-7

Affected: IC 16-21-1

Sec. 1. (a) All hospitals shall be licensed by the department and shall comply with all applicable federal, state, and local laws and rules.

(b) Components required for licensure as a hospital are the following:

1. (1) Governing board.
2. (2) Quality assessment and improvement program.
3. (3) Dietary service.
4. (4) Infection control program.
5. (5) Laboratory service.
6. (6) Medical record service.
7. (7) Medical staff.
8. (8) Nursing service.
9. (9) Pharmaceutical service.
10. (10) Physical environment service.
11. (11) Plant maintenance service.
12. (12) Radiologic service.

(c) Optional services, not required for licensure, shall comply with all rules for that service.

(d) The hospital shall have a plan to address the internal review and reporting of unusual occurrences and disasters. This plan shall cover, but not be limited to, the following:

1. (1) Patient injuries or marked deterioration of patient condition occurring under unanticipated or unexpected circumstances.
2. (2) Chemical poisoning occurring within the hospital resulting in a negative patient outcome.
3. (3) Unexplained loss of or theft of a controlled substance.
4. (4) Missing patient whose whereabouts are unknown for over twenty-four (24) hours.

(e) The hospital shall report the following incidents to the division:

1. (1) Verbal reports within twenty-four (24) hours of occurrence on:

   1. (A) murder, suicide, or kidnapping of patient occurring after admission;
   2. (B) reportable infection outbreaks or food poisonings as required by federal, state, and local law; and
   3. (C) a disruption, exceeding four (4) hours, in the continued safe operation of the hospital or in the provision of patient care, caused by internal or external disasters, strikes by health care workers, or unscheduled termination of vital services.

2. (2) Written reports on occurrences listed in subdivision (1), if requested, shall be submitted to the division within a reasonable period of time and document all information required by the department, including, but not limited to, the following:

   1. (A) An explanation of the circumstances surrounding the incident.
   2. (B) Summaries of all findings, conclusions, and recommendations associated with the review of the incident.
   3. (C) A summary of actions taken to resolve identified problems, to prevent recurrence of the incident, and to improve overall patient care.
3. (3) This subsection does not replace other reporting requirements. Copies of these required reports will be acceptable in satisfying subdivision (2).

(f) In the event of flood, fire, or other disaster, the governing board, or the governing board's designee, or the commissioner shall close all or that part of the hospital as may be necessary to ensure the safety and well-being of patients. The commissioner shall approve reopening.

(Indiana Department of Health; 410 IAC 15-1.2-1; filed Dec 21, 1994, 9:40 a.m.: 18 IR 1262; errata filed Feb 23, 1995, 2:00 p.m.: 18 IR 1837; readopted filed Jul 11, 2001, 2:23 p.m.: 24 IR 4234; readopted filed May 22, 2007, 1:44 p.m.: 20070613-IR- 410070141RFA; readopted filed Jul 14, 2011, 11:42 a.m.: 20110810-IR-410110253RFA; readopted filed Sep 13, 2017, 4:08 p.m.: 20171011-IR-410170339RFA; readopted filed Nov 28, 2023, 12:13 p.m.: 20231227-IR-410230639RFA)