Every facility located in New York State that is regulated by the Department of Health under Article 5 or Article 28 must develop an operation plan and have the plan approved by the Regulated Medical Waste Program before regulated medical waste can be treated on-site by the facility.

If an autoclave is used to treat regulated medical waste, the facility's operation plan must describe in detail the protocol used to validate the effectiveness of the autoclave for treating regulated medical waste.

Any change in procedure related to the operation of the autoclave shall be reflected in a modified plan, which shall be dated with each revision and resubmitted for approval to the Department.

An Autoclave Installation Checklist is provided.