NAC449.999445. Sterilization and disinfection of surgical instruments, items and equipment; training required for employees and contractors responsible for sterilization or disinfection.  


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  •      1. All surgical instruments, items or equipment used in the care of patients at an outpatient facility must be sterilized or disinfected according to the program for the prevention and control of infections and communicable diseases adopted by the outpatient facility pursuant to NAC 449.999442.

         2. If such instruments, items and equipment are sterilized or disinfected by equipment or cleaning agents at the outpatient facility:

         (a) Before an employee or independent contractor may be assigned the responsibility for sterilizing or disinfecting any instrument, item or equipment, the employee or independent contractor must receive training concerning the instructions of the manufacturer of the device or sterilizer for:

              (1) Sterilizing and disinfecting the instrument, item or equipment;

              (2) The use and maintenance of the sterilizer or disinfecting equipment; and

              (3) The agents used to sterilize and disinfect the instrument, item or equipment.

         (b) An employee or independent contractor assigned the responsibility for sterilizing or disinfecting the instrument, item or equipment shall:

              (1) Receive annual training concerning the manufacturer’s instructions described in paragraph (a); and

              (2) Receive training on any new equipment or procedures if there is any change in the equipment or procedures used to sterilize or disinfect an instrument, item or equipment.

         (c) The outpatient facility shall ensure that documentation of all training completed pursuant to this subsection is kept in the file of the employee or independent contractor.

         3. The manufacturer’s instructions for operating any sterilizer or performing any disinfection procedure must be located or posted near the equipment used for sterilization or disinfection.

         4. The outpatient facility shall ensure that each employee or independent contractor follows the manufacturer’s instructions concerning:

         (a) The instruments, items or equipment that may be sterilized or disinfected;

         (b) The procedures for cleaning an instrument, item or equipment before the instrument, item or equipment is sterilized or undergoes high-level disinfection;

         (c) The procedures for sterilizing or disinfecting an instrument, item or equipment;

         (d) The operation and maintenance of the sterilizer or the equipment used for high-level disinfection;

         (e) The frequency and type of biologic indicator testing of the sterilizer;

         (f) The recommended agents for sterilizing and disinfecting the instrument, item or equipment; and

         (g) The frequency of testing of any solution for disinfecting to ensure maintenance of the minimum level of effectiveness, but the solution must be tested not less often than daily.

         5. The effectiveness of the sterilization procedures must be checked by performing a biologic indicator test:

         (a) At least weekly, or more frequently if recommended by the manufacturer; and

         (b) While sterilizing all implantable devices.

         6. Sterilization records and logs of the results of the biologic indicator test must be maintained by the outpatient facility for at least 1 year after the test is performed to ensure that the recommended testing and maintenance of the equipment is performed and the manufacturer’s instructions regarding proper sterilization techniques are followed. Each outpatient facility shall establish a method to track and recall instruments, items or equipment previously sterilized or disinfected if there is a failure of the biologic indicator test.

         7. To aid in environmental control, each outpatient facility shall provide a physical barrier between the decontamination and sterilization areas of the outpatient facility.

     (Added to NAC by Bd. of Health by R179-09, eff. 7-22-2010)