(c) The operation plan shall be designed to promote safe and effective operation of the autoclave. The operation plan shall include, minimally, procedures to ensure:

1. (1) the autoclave meets department criteria for effective treatment of regulated medical waste (i.e., the protocol for validation testing and a summary of the results);
2. (2) loads contain only those items or types of waste for which effective treatment has been demonstrated by validation testing; and exclude waste materials for which effective treatment by the system has not been demonstrated and/or is prohibited pursuant to section 70-2.3 of this Part, and, as applicable, materials expressly excluded in the commissioner's notice of approval;
3. (3) each load is treated using residence time, temperature and pressure that have been validated as effective for the treatment of regulated medical waste, and conditions of treatment are monitored and documented for each load;
4. (4) the effectiveness of treatment is maintained, by including, as applicable, procedures for and frequency of: calibration verification and recalibration of parametric controls; monitoring by challenge testing or other demonstration that treatment has been attained; and preventative maintenance of engineering controls (e.g., charcoal and/or HEPA filters) and diagnostic procedures for electronic controls (e.g., integrated computers and mechanical components);
5. (5) occupational exposure is minimized, and physical injury to operators is prevented during loading, the cycle, and unloading the autoclave; and
6. (6) personnel are knowledgeable about routine operation of the autoclave, are kept current with manufacturer recommendations for operation, and have been instructed in emergency procedures for handling malfunctioning systems and untreated waste. Training programs shall mandate initial training and retraining at least once per calendar year and as necessary for presenting updates on operational information.

(e) Whenever an autoclave fails to operate in accordance with pre-established operating parameters, the facility shall:

1. (1) discontinue use of the autoclave, using emergency shutdown procedures if appropriate until corrective action has been taken and validation testing has verified that effective treatment can resume;
2. (2) handle as untreated all regulated medical waste processed by the system since the last previous run under documented compliance with such requirements;
3. (3) document the failure, including date and autoclave identifier;
4. (4) document the facility response, including corrective action; and

5. (5) whenever a facility has reason to believe untreated waste certified as treated waste has left the facility, notify the waste transporter as soon as practicable, and notify the department within 72 hours of the waste's leaving the facility.

   (f) Monitoring autoclave operator.

6. (1) parametric controls shall be employed to monitor operating parameters automatically and continuously throughout the entire cycle, and generate a record of operating parameters for each cycle.

7. (2) In the absence of parametric controls, routine operational performance of an autoclave shall be monitored by:

   1. (i) challenge testing, conducted every 40 hours of autoclave operation or once a week, whichever occurs first, using the same protocol as was approved by the department for validation testing; and
   2. (ii) time/temperature-sensitive materials used in each load. No autoclave that fails to attain 4 log₁₀ reduction in viable spores concentration upon challenge testing shall be used to treat regulated medical waste. Whenever time/temperature-sensitive materials fail to show expected results (i.e., a color change), the load shall be handled as untreated waste, and the facility shall demonstrate, through a repeat of validation testing, that the autoclave effectively treats regulated medical waste before resuming its use for treatment purposes.