1. (a) The owner or operator of a school or shop subject to 18 AAC 23.010(b) shall ensure that each non-single-use, non-disposable instrument that is required in this chapter to be cleaned and sterilized is

   1. (1) cleaned either

      1. (A) by hand by

         1. (i) rinsing the instrument in a cold water rinse to remove visible soil;
         2. (ii) soaking the instrument in an enzyme pre-soak before cleaning;
         3. (iii) using warm water and an appropriate detergent;
         4. (iv) rinsing the item thoroughly; and
         5. (v) inspecting the instrument carefully for cleanliness and damage; or

      2. (B) mechanically by

         1. (i) rinsing the instrument in a cold water rinse to remove visible soil;
         2. (ii) soaking the instrument in an enzyme pre-soak before cleaning; and
         3. (iii) placing the instrument directly into an ultrasonic cleaner for a 10-minute cycle or as recommended by the manufacturer;
   2. (2) dried after cleaning and placed in a sterilization pouch that has either a sterilizer indicator or internal temperature indicator; and
   3. (3) sterilized in a sterilizer if a package seal on a sterilization pouch containing an instrument has been broken, that instrument may not be used until it is sterilized again.
2. (b) If a school or shop uses only single-use, disposable, sterile instruments and products, sterilization in a sterilizer is not required.

3. (c) The owner or operator shall demonstrate that a sterilizer used in the school or shop is capable of attaining sterilization through a spore destruction test performed every 30 days. These spore destruction tests must

   1. (1) be conducted using a commercially prepared biological sterilization process indicator to culture specifically for Bacillus stearothermophilus for steam sterilizers or Bacillus subtilis for dry heat sterilizers; and

   2. (2) be verified

      1. (A) through a laboratory independent of the school or shop; or
      2. (B) within the school or shop in accordance with the biological sterilization process indicator's manufacturer's instructions.
4. (d) If a laboratory independent of the school or shop is used to conduct a spore destruction test, the owner or operator must obtain results of that test within 24 hours after performing the test.

5. (e) If the results of a spore destruction test are positive for the presence of a spore described in (c)(1) of this section, the owner or operator shall ensure that

   1. (1) any instrument processed in that sterilizer is not used on clients until the instrument is resterilized using the procedures in (a) of this section before use; and
   2. (2) the sterilizer is not used until a negative test result is achieved.

(Eff. 12/1/2002, Register 164)

Authority: AS 08.13.030, AS 08.13.120, AS 08.13.210, AS 44.46.020