Authority: IC 16-21-1-7; IC 16-21-2-2.5

Affected: IC 16-21-1

Sec. 2. (a) Sterilization of equipment and supplies must be provided, within the scope of the service offered, in accordance with acceptable standards of practice or manufacturer's recommendations and applicable state laws and rules (to include 410 IAC 1-4, Universal Precautions). Sterilization services must be directed by a qualified person or persons and must provide for the following:

1. (1) Biological indicators must be used to check sterilization processes at least monthly. Chemical sterilizing indicators must be used to check the sterilizing process of individual packs.

2. (2) Written policies and procedures must be available and followed by personnel responsible for sterilizing equipment and supplies, including, but not limited to, the following:

   1. (A) Minimum time and temperature for processing various size bundles and packs.

   2. (B) Instructions for:

      1. (i) loading;
      2. (ii) operating;
      3. (iii) cleaning; and
      4. (iv) maintaining;
   3. sterilizers.

   4. (C) Instructions for:

      1. (i) cleaning;
      2. (ii) packaging;
      3. (iii) storing;
      4. (iv) labeling; and
      5. (v) dispensing of;
   5. sterile supplies.
   6. (D) The procedure for maintaining and recording the particular sterilizing cycle.
   7. (E) Sterilization of heat labile reusable equipment.

3. (3) Records of results must be maintained and evaluated periodically to include, but not be limited to, the following:

   1. (A) Records of recording thermometers or a daily record of the sterilizing cycle:

      1. (i) date;
      2. (ii) time;
      3. (iii) temperature;
      4. (iv) pressure; and
      5. (v) contents;
   2. for each sterilizer load.
   3. (B) Results of biological indicators used in testing the sterilizing processes.

(b) Environmental surfaces and equipment not requiring sterilization that have been contaminated by blood or other potentially infectious materials must be cleaned then decontaminated in accordance with acceptable standards of practice and applicable state laws and rules (to include 410 IAC 1-4, Universal Precautions).

(Indiana Department of Health; 410 IAC 27-11-2; filed Feb 3, 2006, 2:00 p.m.: 29 IR 1917; readopted filed Jul 12, 2012, 12:09 p.m.: 20120808-IR-410120265RFA; readopted filed Sep 26, 2018, 2:48 p.m.: 20181024-IR-410180328RFA; readopted filed Nov 14, 2024, 1:24 p.m.: 20241211-IR-410230798RFA)