Ind. Admin. Code tit. 410, r. 15-1.5-9 – Radiologic services

Sec. 9. (a) The hospital shall have on-site, or available by arrangement, the diagnostic imaging services required by the needs of the patients served and within the scope of the service provided, that are in compliance with federal and state rules, as follows:

(1) If radiation emitting or nonionizing services, either diagnostic or therapeutic, are provided, the applicable requirements of this section apply. The services may include, but not be limited to the following:
1. (A) Mammography.
2. (B) Computerized tomography.
3. (C) Magnetic resonance imaging.
4. (D) Ultrasound.
5. (E) Catheterization lab.
6. (F) Interventional radiology.
(2) If therapeutic or diagnostic nuclear medicine services are provided, they shall comply with the applicable requirements of this section and with 410 IAC 15-1.6-4.

(b) The services that use ionizing radiation shall not compromise the health, safety, and welfare of patients or personnel in accordance with federal and state rules, as follows:

(1) Proper safety precautions shall be maintained against radiation hazards in accordance with the hospital's radiation and safety program as developed by the radiation safety officer. This includes, but is not limited to, the following:
1. (A) Adequate shielding for patients, personnel, and facilities.
2. (B) Procedures for monitoring:
  1. (i) skin dosage;
  2. (ii) radionuclide contamination;
  3. (iii) quality control;
  4. (iv) technique charts, where applicable; and
  5. (v) handling of hazardous materials.
3. (C) Appropriate storage, use, and disposal of radioactive materials.
(2) Equipment shall be inspected, tested, and calibrated at least annually by qualified personnel with appropriate documentation reasonably available.
(3) Hazards and faulty equipment identified shall be promptly corrected in accordance with current standards of practice and applicable federal and state rules to include, but not be limited to, collimation and filtration, and evaluation of equipment performance.
(4) Written preventive maintenance policies and procedures, in accordance with manufacturer's recommendations and hospital policy, shall be maintained and compliance shall be documented.

(c) Procedures and treatments are performed on the written request of individuals and practitioners allowed to order such procedures and treatments and receive the results of the evaluations to the extent permitted by law and authorized by the governing body.

(d) A full-time, part-time, or consulting radiologist or physician qualified by education and experience in the service provided as determined by the medical staff shall do the following:

(1) Supervise the service provided.
(2) Ensure that only personnel use the equipment and administer procedures who:
1. (A) have been designated as qualified by the medical staff; and
2. (B) are allowed to do so in accordance with current standards of practice and state rules.
(3) Interpret those tests that are determined by the medical staff to require a radiologist's or appropriately credentialed physician's specialized knowledge.
(4) Be available for consultation for the quality and necessity of diagnostic imaging, nuclear medicine, and therapeutic procedures, if applicable.

(e) Records shall be maintained as follows:

(1) The radiologist or other practitioner shall authenticate reports of his or her interpretations.
(2) The hospital shall maintain the following for at least five (5) years:
1. (A) Copies of reports and printouts.
2. (B) Films, scans, and other image records.
3. (C) If clauses (A) and (B) are maintained in the medical record, these items shall be maintained in accordance with state and federal law.

(Indiana Department of Health; 410 IAC 15-1.5-9; filed Dec 21, 1994, 9:40 a.m.: 18 IR 1275; 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)