Cal. HSC § 119315 — California Code / Code hsc / Division 104 / Part 15 / Chapter 7 / Article 4 / Section 119315
Section 119315
Status: in_force

A body art facility shall conform to the following sterilization procedures:

(a) Clean instruments to be sterilized shall first be sealed in sterilization packaging that contain either a sterilizer indicator or process indicator, unless instruments are being processed for immediate use. The outside of the pack shall be labeled with the name of the instrument if not immediately identifiable, the date sterilized, and the initials of the person operating the sterilizing equipment unless instruments are being sterilized for immediate use.

(b) Sterilizers shall be loaded, operated, decontaminated, and maintained according to manufacturer’s directions, and shall meet all of the following standards:

(1) Only equipment manufactured for the sterilization of medical instruments shall be used.

(2) Sterilization equipment shall be tested using a commercial biological indicator monitoring system after the initial installation, after any major repair, and at least once per month. The expiration date of the monitor shall be checked prior to each use.

(3) Each sterilization load shall be monitored with mechanical indicators for time, temperature, and pressure. Each sterilization load shall include, at a minimum, a Class V integrator.

(4) Biological indicator monitoring test results shall be recorded in a log that shall be kept on site for three years after the date of the results.

(5) A written log of each sterilization cycle shall be maintained for three years, shall be available for inspection by the enforcement officer, and shall include all of the following information:

(A) The date of the load.

(B) A list of the contents of the load.

(C) The exposure time and temperature.

(D) The results of the Class V integrator.

(E) For cycles where the results of the biological indicator monitoring test are positive, how the items were cleaned, and proof of a negative test before reuse.

(c) Clean instruments and sterilized instrument packs shall be placed in clean, dry, labeled containers, or stored in a labeled cabinet that is protected from dust and moisture.

(d) Sterilized instruments shall be stored in the intact sterilization packaging or in the sterilization equipment cartridge until time of use.

(e) Sterile instrument packs shall be evaluated at the time of storage and before use. If the integrity of a pack is compromised, including, but not limited to, cases where the pack is torn, punctured, wet, or displaying any evidence of moisture contamination, the pack shall be discarded or reprocessed before use.

(f) A body art facility that does not afford access to a decontamination and sterilization area that meets the standards of subdivision (c) of Section 119314 or that does not have sterilization equipment shall use only purchased disposable, single-use, presterilized instruments. In place of the requirements for maintaining sterilization records, the following records shall be kept and maintained for a minimum of 90 days following the use of the instruments at the site of practice for the purpose of verifying the use of disposable, single-use, presterilized instruments:

(1) A record of purchase and use of all single-use instruments.

(2) A log of all procedures, including the names of the practitioner and client and the date of the procedure.

(3) Written proof on company or laboratory letterhead showing that the presterilized instruments have undergone a sterilization process. Written proof shall clearly identify the instruments sterilized by name or item number and shall identify the lot or batch number of the sterilizer run.