Ind. Admin. Code tit. 410, r. 15-1.6-3 – Nuclear medicine services

Sec. 3. (a) If the hospital provides nuclear medicine services, the service shall meet the needs of the patients served, within the scope of the service offered, in accordance with acceptable standards of practice, and comply with applicable requirements of 410 IAC 15-1.5- 9.

(b) Radioactive materials shall be prepared, labeled, used, transported, stored, and disposed of in accordance with acceptable standards of practice, and federal and state law, as follows:

(1) In-house preparation of radio-pharmaceuticals is by, or under, the direct supervision of an appropriately trained registered pharmacist or physician.
(2) There is proper storage and disposal of radioactive material.
(3) If clinical laboratory tests are performed in the nuclear medicine service, the service shall meet the requirements for laboratory services, in this article, with respect to the following:
1. (A) Management.
2. (B) Adequacy of facilities.
3. (C) Proficiency testing.
4. (D) Quality control.

(1) be appropriate for the types of nuclear medicine services offered;
(2) be maintained in safe operating condition; and
(3) be inspected, tested, and calibrated at least annually by qualified personnel.

(d) The hospital shall maintain the following:

(1) Signed and dated reports of nuclear medicine interpretations, consultation, and procedures in accordance with applicable requirements of 410 IAC 15-1.5-9(e).
(2) Records of the receipt and disposition of radio-pharmaceuticals in accordance with federal and state rules.

(Indiana Department of Health; 410 IAC 15-1.6-3; filed Dec 21, 1994, 9:40 a.m.: 18 IR 1277; 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)