Section 970. User verification

A. To verify that the medical waste treatment unit is functioning properly and that performance standards are achieved, the petitioner shall:

1. Demonstrate that required resistant bacterial endospores are inactivated to criteria as specified in 9VAC20-120-910 B under standard operating procedures using protocols that have previously been approved by the department as specified under 9VAC20-120-950 and 9VAC20-120-960;

2. Establish a frequency of biological monitoring; and

3. Document and record all biological indicator and parametric monitoring data.

B. To document treatment efficacy for steam sterilizers and autoclaves, the equipment operator shall:

1. Adopt standard written operating procedures that denote:

a. Sterilization cycle time, temperature, pressure

b. Types of waste acceptable

c. Types of containers and closures acceptable

d. Loading patterns or quantity limitations;

2. Document times/temperatures for each complete sterilization cycle;

3. Use time-temperature sensitive indicators to visually denote the waste has been decontaminated;

4. Use biological indicators placed in the waste load (or simulated load) periodically to verify conditions meet microbial inactivation requirements as specified in 9VAC20-120-910 B; and

5. Maintain all records of procedure documentation, time-temperature profiles, and biological indicator results.

Historical Notes

Derived from VR672-40-01:1 § 11.14, eff. June 29, 1994.

Statutory Authority

Chapter 14 (§ 10.1-1400 et seq.) of Title 10.1 of the Code of Virginia.