N.J. Admin. Code § 8:27-5.4
Current through Register Vol. 56, No. 12, June 17, 2024
Section 8:27-5.4 - Biological and chemical monitoring(a) All steam sterilizers shall be biologically tested on a monthly basis and following repair or breakdown. The biological indicator test for steam sterilization shall consist of bacillus sterothermophilus spores. These tests shall be verified through an independent laboratory.(b) Biological monitoring of the steam sterilization cycle shall be conducted in a fully loaded chamber or as recommended by the sterilization manufacturer. The biological monitor shall be placed in the center of the load towards the front of the chamber.(c) The following actions shall be taken if a biological indicator tests positive. 1. The independent laboratory shall notify the body art establishment within 24 hours of a positive test result;2. The body art operator shall notify the local health authority of the positive test and inform him or her of the follow-up steps;3. Instruments processed in that sterilizer shall be considered non-sterile and shall be reprocessed before use;4. The sterilizer in question shall be immediately re-challenged with a biological indicator; and5. The sterilizer shall not be used until a satisfactory test result (no growth) is reported by the independent laboratory.(d) All biological test records shall be retained by the operator for a period of three years and made available upon request.(e) Sterilizers with recording charts or printouts shall include a chemical integrator in the first working load each day a sterilization cycle is run. 1. All charts/printouts shall be reviewed and initialed by the sterilizer operator at the completion of each cycle and initialed to verify that all cycle parameters were met.(f) Sterilizers without recording charts/printouts shall include a chemical integrator in each load run. 1. If the chemical integrator fails to meet the cycle parameters, all of the load contents shall be reprocessed.N.J. Admin. Code § 8:27-5.4