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Virginia Administrative Code
Title 9. Environment
Agency 20. Virginia Waste Management Board
Chapter 121. Regulated Medical Waste Management Regulations
7/21/2024

9VAC20-121-330. Regulated medical waste management plan.

A. All permitted regulated medical waste management facilities, such as regulated medical waste transfer stations or treatment facilities, shall prepare and maintain a written regulated medical waste management plan. The plan shall include a certification page signed by a responsible official. This signature shall certify the plan meets the requirements of this chapter. The plan shall be maintained in the operating record and shall be made available for review by the department upon request. The plan shall include, at a minimum, the items in subsections B through G of this section.

B. A written waste acceptance plan, which includes, at a minimum:

1. Types and quantities of regulated medical waste to be managed, including sources of the waste and proposed service areas (if waste is accepted from offsite). The plan shall identify:

a. Acceptable waste types for treatment onsite (if applicable); and

b. Acceptable wastes types to be transferred to another approved facility for treatment or management offsite. The plan shall include a description of the offsite facility that will receive the waste, including the name, address, and telephone number for the receiving facility and how specific waste types will be managed.

2. Protocols for identification and segregation of regulated medical waste from other types of waste, including radioactive wastes, hazardous wastes, and other solid waste. The plan shall include a description of how incoming waste will be monitored to detect the presence of radioactive materials and actions that will be taken to verify the source of any alarm.

3. Procedures for handling Category A waste in accordance with 9VAC20-121-160.

4. Facilities that accept regulated medical waste from offsite shall include the following:

a. A description of onsite traffic control, schedules, and routing for waste delivery vehicle flow and methods of enforcement of traffic flow plans for the waste delivery vehicles;

b. Procedures for arrival confirmatory inspections of each delivery vehicle and their loads to ensure that the waste has been packaged and transported in accordance with the U.S. Department of Transportation Hazardous Materials Regulations and this chapter;

c. A description of how the waste will be off-loaded, weighed, and compared to the shipping paper that accompanies the waste and how any discrepancies will be resolved; and

d. For each generator or customer, the facility shall maintain a signed certificate, contract, or equivalent document for each load or inclusive of all loads received from the generator in which the generator affirms that the loads do not contain unauthorized waste.

5. Procedures for handling regulated medical waste received from onsite or offsite that is not packaged, labeled, or marked correctly; leaking, dented, ripped, torn, bulging, or otherwise damaged; or not accompanied by a shipping paper.

C. A written description of the procedures for the detection and management of unauthorized waste in accordance with 9VAC20-121-230 K. The plan shall contain, at a minimum:

1. A list of unauthorized waste types that are not acceptable for management at the facility.

2. Methods used by the operator to prevent management of unauthorized wastes, such as routine monitoring and observation of incoming waste, generator agreements, and informational materials.

3. Procedures to detect and address any unauthorized waste discovered at the facility, including the protocol for identifying and contacting the generator and to prevent recurrence.

4. Procedures for containing and storing each type of unauthorized waste, such as radioactive or hazardous waste, until it is removed for proper management, including designated storage locations, storage timeframes, packaging, and labeling.

5. Instructions for documenting and notifying the department of receipt and ultimate disposition of unauthorized waste.

D. A written operations plan that includes, at a minimum:

1. A general description of the overall process and equipment used. The plan shall include the following: hours of operation; process rate; procedures for daily startup; methods, containers, and other devices for the collection, off-loading, tipping, and conveyance of regulated medical waste from the point of generation or receipt to areas for processing; normal loading, unloading, and waste handling procedures; and timeframes for transfer or treatment.

2. Protocols for packaging and labeling regulated medical waste for treatment onsite or transport offsite, including protocols for labeling or marking wheeled carts, containers, conveyance systems, or other items used for moving regulated medical waste.

3. Procedures for temporary onsite storage of regulated medical waste until it is collected for treatment onsite or transport offsite. The plan shall identify each storage location and capacity, the maximum length of time the waste will be stored, and procedures used to document compliance with required storage timeframes.

4. Methods and equipment used to empty, clean, and disinfect reusable containers in accordance with 9VAC20-121-130, including types and quantities of reusable containers and disinfectant to be used, disinfection procedures utilized between uses, and final disposal in case of damage or wear and tear. The plan shall also include a description of appropriate personal protective equipment, such as puncture and leak resistant gloves, safety glasses or face shield, protective coveralls or bib, protective footwear, and mask or respiratory protection as needed, used to protect personnel when cleaning and disinfecting reusable containers.

5. Procedures for spill prevention and response and how spilled waste will be collected, packaged, and the spill area decontaminated in accordance with 9VAC20-121-140. This includes locations and contents of all spill containment and cleanup kits.

6. Names, addresses, and telephone number of final treatment or ultimate disposal facilities to be used for untreated waste and treated residues, facility-generated wastes, unauthorized waste, hazardous waste, radioactive waste, and other waste bypassed or disposed.

7. A description of equipment and procedures used to control access to areas used for the storage, transfer, and treatment of regulated medical waste. The plan shall identify all entry and exit points where access is controlled.

8. Methods and equipment used for routine cleaning and disinfection of facility equipment, floors, vehicles, and other surfaces that come into contact with regulated medical waste.

9. Measures used to control and monitor for fire, dust, noise, litter, odors, vectors, and blowing debris at the facility.

10. Collection and management of effluent, wash water, and other runoff from facility floors, storage and processing areas, waste compactors, and reusable container cleaning and disinfection areas, including location and discharge of drains.

11. Identification of all appropriate personal protective equipment, such as puncture and leak resistant gloves, safety glasses or face shield, protective coveralls or bib, protective footwear, and mask or respiratory protection as needed, and when the items are used to protect personnel managing regulated medical waste at the facility. The plan shall also include a description of donning and offing procedures for personal protective equipment.

12. A self-inspection plan that at a minimum includes copies of the inspection checklists that comply with 9VAC20-121-230 U along with a description of the types of potential problems and corrective actions that may result from the inspections.

13. A schedule and description of initial and annual refresher training to be provided to employees in-person, in a language they can understand, including interactive training, and the types and numbers of adequately trained personnel. Initial training shall be provided within seven working days of employment, and annual refresher training shall be provided within one year from the date of the last training. Training shall include:

a. Operational procedures in accordance with 9VAC20-121-230 V;

b. Protocols to recognize, manage, document, and report unauthorized waste in accordance with 9VAC20-121-230 K;

c. Procedures for retraining staff when noncompliance or other incidents occur; and

d. Any other specialized waste training specific to the job function.

14. Procedures for recordkeeping in accordance with 9VAC20-121-340. The procedures shall address how inventory will be managed and methods used to track, link, and document specific incoming waste loads to specific outgoing waste loads.

15. A description of the type and estimated daily quantity of any facility-generated waste residues and procedures for handling and disposal of the residues.

E. A written treatment plan for each unit used to treat regulated medical waste that meets the standards of 9VAC20-121-240 and 9VAC20-121-250 and includes at a minimum:

1. A detailed description of the treatment technology to be used, including:

a. An overview of the treatment process and description of the treatment unit, including manufacturer, model name or number, and treatment capacity;

b. Procedures for equipment startup and shut down including warm-up, loading and unloading wastes, and anticipated load size during routine operation;

c. A description of built-in automatic controls and fail safe mechanisms to ensure the waste cannot bypass the treatment process;

d. If applicable, methods used to grind, shred, or puncture containers or packaging before, during, or after treatment, along with the methods to prevent exposure to the waste; contain any aerosol, bioaerosol, or mists caused by the process; and treat or filter any air evacuated from the chamber during processing;

e. If applicable, methods to transfer from a grinder or shredder to or from a treatment unit under forced draft ventilation that removes fumes from the operations area to a safe discharge;

f. Methods for maintaining negative pressure atmospheric control in the vessel and filtering all vents, discharges, and fugitive emissions of air from the process units through a high efficiency particulate air (HEPA) filter with efficiency of 99.97% for 0.3 microns. Installation and maintenance of filters shall be specified;

g. Methods to manage effluent including location and discharge of drains; and

h. A description of preventative maintenance that is performed on the treatment unit, including on engineering and electronic controls.

2. Identification of acceptable waste types to be treated and a listing of types of wastes that shall not be treated.

3. Treatment unit operating parameters (e.g., cycle duration, temperature, pressure, chemical concentration, irradiation exposure time, or other treatment parameters as applicable) and a description of how the operating parameters will be monitored and recorded, including number, type, and location of parametric monitoring devices, thermochemical indicators, and thermochemical recording devices, as applicable for routine operation.

4. Identification of the biological indicators to be used and documentation that lack of growth in the treated indicator corresponds to a 6 Log10 reduction of viable spores. An explanation of why each indicator is suitable for the treatment process and wastes to be treated, including referencing any standards, guidelines, or information from peer reviewed journals, shall be included. The facility shall also specify the:

a. Type of biological indicators (spore strip, suspension, or self-contained), including a copy of the supplier's certificate of performance (or certificate of analysis) that identifies the organism (genus, species, strain, and population), purity, and for thermal treatment systems (including autoclaves) the D-value, and Z-value;

b. Estimated shelf life and storage conditions to be maintained;

c. Culture medium, incubation procedures, and incubation time (for self-contained biological indicators) and the media, growth, and culture conditions (for non-self-contained biological indicators), including how the results are to be interpreted and recorded;

d. Carrier system or material and primary packaging;

e. Relative resistance to temperature, pressure, chemicals, irradiation, infectious agents, or any other conditions used in the treatment process; and

f. Number, location, and placement of untreated (control) and treated indicators relative to the coldest spot in the treatment unit as identified by the manufacturer.

5. Number, type, and placement of thermochemical indicators, including a description of how results will be interpreted and recorded.

6. A validation plan that includes a detailed description of the validation testing protocol used to demonstrate effective treatment by each treatment unit that meets the standards of 9VAC20-121-260 and includes:

a. Surrogate waste load composition, including packaging type, porosity, relative percentages of inorganic and organic components, moisture content, thermal resistance, and a relative breakdown of solid components, such as blood culture bottles, plastics (including suction canisters), microbiological waste, and sharps;

b. Load configuration including packing density, orientation, and load size;

c. Number, type, and location or placement of biological indicators; thermochemical indicators; thermochemical recording devices; and any other methods used to monitor operating parameters and accuracy of parametric monitoring devices during validation runs to ensure that the gauge or electronic read-out is a true reflection of conditions inside the treatment unit;

d. A description of how the results will be interpreted and documented; and

e. Identification of who will conduct the validation testing.

7. A detailed description of the periodic challenge testing procedures used to evaluate the effectiveness of each treatment device under full loading, which meets the standards of 9VAC20-121-270 and includes:

a. Frequency of challenge testing to be performed;

b. Number, type, and location or placement of biological and thermochemical indicators, and other methods used to monitor operating parameters;

c. A description of how the results will be interpreted and documented;

d. Procedures used to address challenge test failures, including evaluating and correcting any issues with the treatment cycle and unit, and management of untreated regulated medical waste to include temporary storage or diversion to another approved facility for treatment or disposal; and

e. Procedures for reporting failing results of challenge testing to the department in accordance with 9VAC20-121-340.

8. Identification of all appropriate personal protective equipment, such as puncture and leak resistant gloves, safety glasses or face shield, protective coveralls or bib, protective footwear, and mask or respiratory protection as needed, and when the items are used to protect personnel.

9. Safety procedures used to minimize occupational exposure and prevent physical injury to operators during loading, unloading, and treatment cycle.

10. Procedures for handling and disposing of treated wastes, including packaging, labeling, and transport.

11. A copy of the treated waste disposal plan in accordance with 9VAC20-121-280 D.

F. A written emergency contingency plan that describes the organized, planned, coordinated courses of action to be followed in the event of emergencies and nonoperation. In addition to submission to the department, the plan shall be provided to the local police and fire departments, local emergency manager, and local emergency health coordinator. The plan shall include:

1. Procedures to minimize hazards to human health and the environment from utility failure, fires or explosions, spills, leaks and releases, and exposure to regulated medical waste.

2. A description of the actions facility personnel shall take in the event of various emergency situations (fire, explosion, catastrophic loss, temporary shutdown, release of regulated medical waste or regulated medical waste constituents, or other incident that could threaten human health or the environment), including evacuation procedures.

3. A list of available fire protection and emergency equipment, and appropriate uses, such as fire extinguishers, emergency safety showers, eye wash stations, spill control materials, and alarm systems.

4. Procedures to be employed in the event of equipment breakdown or maintenance events, including standby equipment, extension of operating hours, or diversion of waste to another facility.

5. A list of onsite and offsite backup equipment with names and telephone numbers where offsite equipment may be obtained.

6. Provisions for loading, unloading, storage, transfer, treatment, or other disposal capabilities to be used during emergency situations, including when the facility downtime exceeds 24 hours.

7. The designation of alternate treatment areas or plans for transfer of stored waste in the event facility or system downtime exceeds 72 hours.

8. Procedures for spill cleanup and decontamination following a release of regulated medical waste.

9. A description of arrangements made with the local police and fire department that allow for immediate entry into the facility by their authorized representatives should the need arise, such as in the case of response personnel responding to an emergency situation.

10. The telephone numbers for local fire and police departments.

11. An identification of personnel designated as emergency coordinators. A list of names, addresses, and phone numbers (office and home) of all persons qualified to act as an emergency coordinator for the facility. Where more than one person is listed, one shall be named as primary emergency coordinator and the other shall be listed in the order in which they will assume responsibility as alternates. The emergency coordinator must be onsite or on-call and is responsible for responding to emergencies and coordinating emergency response measures.

12. A description of where and how emergency response information will be posted.

G. A written closure plan that identifies the steps necessary to completely close the facility or unit at its full operation under the permit conditions, which includes:

1. Procedures for removal of regulated medical waste, treated residue, and other materials for proper treatment or disposal;

2. Methods for cleaning and disinfecting the unit or facility and all related equipment, structures, and surfaces;

3. A description of any sampling to be conducted to ensure the facility has been decontaminated;

4. A schedule for final closure including, as a minimum, the anticipated date when wastes will no longer be received, the date when completion of final closure is anticipated, and intervening milestone dates that will allow tracking of the progress of closure; and

5. Actions necessary for facility abandonment or uses other than for regulated medical waste management.

Statutory Authority

§ 10.1-1402 of the Code of Virginia; 42 USC § 6941 et seq.; 40 CFR Part 257.

Historical Notes

Derived from Virginia Register Volume 39, Issue 13, eff. March 15, 2023.

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