Administrative Code

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Virginia Administrative Code
Title 9. Environment
Agency 20. Virginia Waste Management Board
Chapter 120. Regulated Medical Waste Management Regulations

9VAC20-120-960. Site approval process.

A. To fulfill treatment efficacy and information requirements for site approval, the equipment user shall:

1. Demonstrate that the equipment cited is the same equipment and process approved by the department as specified in 9VAC20-120-950.

2. Demonstrate that required resistant bacterial endospores are inactivated as specified in 9VAC20-120-910 B criteria under typical waste load and department specified challenge compositions;

3. Verify that user verification protocols adequately demonstrate treatment effectiveness; and

4. Verify the treatment efficacy relationship between biological indicator data and data procured from real-time parametric treatment monitoring equipment.

B. The site facility shall provide a written operations plan that includes:

1. The names or positions of the equipment operators;

2. The waste types or categories to be treated;

3. Waste segregation procedures required;

4. Wastes types prohibited for treatment;

5. Equipment operation parameters;

6. Treatment efficacy monitoring procedures;

7. Personal protective equipment requirements;

8. Emergency response plans; and

9. Operator training requirements.

C. The site facility shall submit to the department for their review:

1. Equipment model number and serial number;

2. Equipment specification and operations manual;

3. A copy of the facility's written plan; and

4. Certification documentation of operator training.

D. As a condition of site approval, the department shall have a right to inspect the facility and the right to revoke site approval if health and safety violations are discovered, if permit conditions are not being fulfilled, or if the facility is not adhering to its written plan.

E. Any modifications to the medical waste treatment unit may require re-approval by the director and may involve further efficacy testing.

Statutory Authority

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

Historical Notes

Derived from VR672-40-01:1 § 11.13, eff. June 29, 1994.

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