Background Information

Definition of Regulated Medical Waste

Managing Reglated Waste

Occupational Safety and Health (OSHA)

More Information

Contacts

Statutes, Regulations and Guidelines

Additional Resources

 

Background Information

Medical waste differs from hazardous waste. Hazardous waste is regulated by the US EPA (and related state rules) under the Resource Conservation and Recovery Act. Medical waste is not covered federal environmental laws or US EPA regulations (with the exception of a medical waste that also meets the definition of hazardous waste). Rather, medical waste is mostly controlled by state law and associated regulations. In addition to state environmental agency laws/rules, aspects of medical waste management are also controlled by the Occupational Safety & Health Administration (federal and/or state) and Department of Transportation (federal and state).

Each of our 50 states have developed rules and implemented regulations for medical waste. The state rules vary to some extent, including terminology. Depending on which state you live in, you may hear the terms regulated medical waste, biohazardous waste or infectious medical waste. In most cases, these terms all refer to the same thing: that portion of the medical waste stream that may be contaminated by blood, body fluids or other potentially infectious materials, thus posing a significant risk of transmitting infection.

Most states have regulations covering packaging, storage, and transportation of medical waste. Some states require health care facilities to register and/or obtain a permit. State rules may also cover the development of contingency plans, on-site treatment, training, waste tracking, recordkeeping, and reporting.

In most states, the environmental protection agency is primarily responsible for developing and enforcing regulations for medical waste management and disposal. Although in some states, the department of health may play an important role or even serve as the primary regulatory agency. Where both agencies are involved, typically the department of health is responsible for on-site management and the environmental agency is responsible for transportation and disposal.

OSHA, whether it is the U.S. Department of Labor Occupational Safety & Health Administration or an OSHA state program (24 states operate their own program), regulates several aspects of medical waste, including management of sharps, requirements for containers that hold or store medical waste, labeling of medical waste bags/containers, and employee training. These standards are designed to protect healthcare workers from the risk of exposure to bloodborne pathogens. However, they also help to systematically manage wastes, which benefit the public and environment.

Regulated medical waste is defined by the US Department of Transportation as a hazardous material. DOT rules mostly apply to transporters rather than healthcare facilities; although, knowledge of these rules is important because of the liability associated with shipping waste off-site.

Definition of Infectious Medical Waste

There are eight categories of infectious medical wastes in West Virginia:

• Cultures and stocks of microorganisms and biologicals
• Blood and blood products
• Pathological wastes
• Sharps (Sharps which are rendered noninfectious and encapsulated in a solid state on-site may be discarded as solid waste)
• Animal waste
• Isolation wastes
• Residue (e.g., soil, water, debris) from clean up of infectious medical waste
• Waste contaminated or mixed with infectious medical waste

For the complete definition of infectious medical waste see Statutes, Regulations, and Guidelines below.

Managing Infectious Medical Wastes

In this section, you will find the key rules that apply to the management of the Infectious Medical Waste (IMW) stream inside your facility.

Most hospitals and similar medical facilities are termed non-commercial infectious medical waste facilities, because they generate and in some cases treat infectious medical waste (commercial infectious medical waste facilities are typically facilities that treat and dispose of infections medical waste). Non-commercial infectious medical waste facilities that generate less than 50 pounds per month of IMW are termed small quantity generators and have fewer requirements to meet.

Hospitals and similar healthcare facilities must develop and follow an infectious medical waste management plan that addresses various aspects of waste management. The required contents of the plan are detailed in the Infectious Medical Waste rules (Title 64, Series 56-5). Examples of required elements include: methods used for handling, storage, separation, volume-reduction, and treatment; responsibilities of personnel; training; off-site disposal plans; and contingency plans.

Registration, Permits

It is illegal to transport, treat or dispose of infectious medical without first obtaining a permit from the Department of Health and Human Resources. Hospitals and similar healthcare facilities must provide public notice on intent to apply for a permit and maintain a public participation file. The application for a permit must be submitted to Department of Health and Human Resources on prescribed forms. Permits must be renewed annually. Prior to any major changes (e.g., adding a new treatment unit) being made, the facility must submit an application for approval.

Labeling Requirements

Infectious medical waste must be labeled prior to being stored on-site or transported off-site. The label must be securely attached to the outer layer of packaging and must be clearly legible. The label may be a tag securely affixed to the package. Indelible ink must be used to complete the information on the label, and the label must be at least three (3) inches by five (5) inches in size. The following information shall be included on the label:

• The name, address, business telephone and fax numbers of the generator;
• The words "infectious medical waste" or "biomedical waste" or "biohazard" or "regulated medical waste";
• The name, address, business telephone and fax numbers of all transporters, treatment facilities, or other persons to whose control the infectious medical waste is being transferred and the permit numbers of transporters, if applicable; and
• The date on which the infectious medical waste was packaged.

Recognizable treated noninfectious medical waste must be labeled prior to being transported off-site. Treated medical waste that will pass through a screen with a one-half inch (2O) grid is considered not recognizable. The label must be sized and attached in the manner described above. The following information shall be included on the label:

• The name, address and business telephone and fax numbers of the generator;
• The name, address, and business telephone and fax numbers of the facility at which the waste was rendered noninfectious;
• The weight of the treated noninfectious medical waste and the method of treatment;
• A signed and dated certification by the facility at which the waste was rendered noninfectious.

All infectious medical waste must be packaged using specific methods prior to storage, treatment, or transport. The following summarizes key packaging requirements. Details can be found in the Infections Medical Waste rules (Title 64, Series 56-6).

 

• Infectious medical waste must be contained and sealed on-site in leak-proof plastic bags.
• Free liquids must be contained in break-resistant, tightly stoppered containers. Heavier materials must be supported in double-walled corrugated fiberboard boxes or equivalent rigid containers.
• Sharps must be collected at the point of generation in rigid, leak-proof and puncture-resistant containers clearly marked as infectious medical waste. If the sharps are to be stored or treated off-site, the containers must be placed inside a plastic bag. Prior to storage, the plastic bags must be bound at the gathered open end with tape or another closing device that prevents leakage of liquids.
• All bags containing infectious medical waste must be red in color except that infectious medical waste that is to be steam treated must be contained in orange bags and marked with autoclave tape or other heat-activated ink which will indicate whether or not the appropriate temperature has been reached. Both red and orange bags must be imprinted with the international biohazard symbol and the words "infectious medical waste" or "biomedical waste" or "biohazard" or "regulated medical waste" if treatment is to occur off-site.
• All infectious medical waste which is to be transported off-site must also be packaged in double-wall corrugated fiberboard boxes or equivalent rigid containers. The boxes or containers must be leak-resistant or lined with a tear-resistant leak-proof plastic bag. Reusable containers must be leak-proof and vermin- proof, must have tight-fitting covers, and be kept clean and in good repair.

Storage

Storage rules apply at any time after packaging (sealing) for transport, including time spent during transportation and at all treatment and disposal sites or facilities. The key storage rules include:

Infectious medical waste other than sharps shall not be stored for more than thirty (30) days prior to transportation to an infectious medical waste management facility, even if refrigerated: Provided, that the total amount of storage time, including transportation to an infectious medical waste management facility, shall not exceed forty-five (45) days. Facilities that treat infectious medical waste on-site must not store the infectious medical waste more than thirty (30) days.

• Infectious medical waste must be stored in a specifically designated area located at or near the treatment site, or at the pickup point if it is to be transported off-site for treatment.
• The manner of storage must maintain the integrity of the containers; prevent the leakage of waste from the container; provide protection from water, rain and wind, and maintain the waste in a non-putrescent state.
• All storage areas shall be constructed of materials which are durable, easily cleanable, impermeable to liquids, and vermin-proof.
• Carpets and floor coverings with open seams in which water may be entrapped must not be used in storage areas. All floor drains must discharge directly to a sanitary sewage disposal system which is in compliance with sewage system rules or a containment system which prevents any spilled materials from reaching the environment.
• All storage areas must be kept clean and in good repair.
• All storage areas must have access control. The areas must be posted prominently with the international biohazard symbol and with warning signs located adjacent to the exterior of entry doors, gates or lids which indicate the use of the area for storage of infectious medical waste and that entry to unauthorized persons is denied.
• Compaction of infectious medical waste or subjecting infectious medical waste to violent mechanical action is prohibited unless as a part of an approved treatment process.

All hospitals and similar healthcare facilities must keep a spill containment and cleanup kit within the vicinity of any area where infectious medical waste is managed on a bulk storage basis. The location of the kit must provide for rapid and efficient cleanup of spills anywhere within the area. The kit must contain:

• Absorbent material sufficient to have a rated capacity of one gallon of liquid for every cubic foot of infectious medical waste that is normally managed in the area for which the kit is provided or of ten (10) gallons, whichever is less;
• one gallon of hospital grade disinfectant in a sprayer;
• enough red plastic bags to enclose 150% of the maximum quantity stored or transported.
• two (2) new sets of overalls, gloves, boots, caps, and devices to protect the eyes and respiratory tract, and tape for sealing wrists and ankles.
• an adequate first aid kit; and
• one hundred (100) yards of boundary marking tape.

Immediately following a spill of infectious medical waste or its discovery, all individuals present must leave the area until any aerosol settles. The cleanup crew must implement the following procedures for cleaning up a spill:

• put on cleanup outfits;
• secure the spill area from entry by unauthorized persons;
• spray all broken containers of infectious medical waste with disinfectant;
• place broken containers and spillage in the packing bags in the kit;
• disinfect and take other steps necessary to clean up the area;
• clean and disinfect non-disposable items and clothing;
• remove cleanup outfits and place disposable items in a cleanup bag; and
• take prompt steps to initiate procedures for the replenishment of the containment and cleanup kit.

When a spill involves a single container of infectious medical waste with a weight of less than fifty (50) lbs. and a volume of spilled liquid of less than one (1) quart, the individual responsible for the cleanup may elect to use dress and procedures other than those described above. Any proposed alternate procedures for small quantity spills must be specified in the infectious medical waste management plan and must provide protection to the health of workers and the public equivalent to that provided by the regulations.

Training Requirements

Employers must provide training to employees involved with packaging, labeling, storage, or treatment of infectious medical waste.

Recordkeeping and Reporting

All pertinent records required by the Infectious Medical Waste rules must be retained for a period of not less than three (3) years. The period of retention extends automatically during the course of any unresolved enforcement action regarding the regulated activity.

All records must be made available for inspection and or duplication by the Department of Health and Human Resources upon request.

All generators, except small quantity generators and those listed in Section 2 of this rule, commercial storage and transfer facilities and treatment facilities must submit an annual report annually covering the preceding calendar year to the Health Department by January 20th.

Treatment and Disposal of Infectious Medical Waste

In this section, you will find information on the proper final disposition of the Infectious Medical Waste (IMW) stream, including IMW sent off-site and IMW treated on-site.

Off-Site Transport/Disposal

Most hospitals and similar healthcare facilities contract for the transport of infectious medical waste and therefore, a detailed description of applicable rules is not presented here. However, some basic transporter requirements are listed below for informational purposes, in the event you have questions regarding your transporter or their procedures:

• Infectious medical waste may only be transported by a permitted transporter (there is an exception of small quantity generators) and the waste must be delivered to a permitted infectious medical waste management facility.
• Vehicles used for transporting infectious medical waste must be prominently with specific markings (e.g., international biohazard symbol).
• The cargo-carrying portion of the vehicle must be closed and secured except when loading or unloading infectious medical waste to prevent unauthorized access and exposure to wind and precipitation.
• The vehicle must be cleaned and disinfected following leakage or spills.
• The vehicle must be equipped with a spill containment and cleanup kit.

Manifests:  A generator of infectious medical waste that is to be transported off-site for storage or treatment must initiate a four-part manifest, which are available from the Department of Health and Human Resources. Copy three (3) of the manifest must be retained by the generator after acceptance by the transporter. Copy two (2) of the manifest must be retained by the transporter after acceptance by the treatment facility. Copy one (1) of the manifest must be retained by the treatment facility: The treatment facility must forward the original to the generator. A transporter who commingles loads must initiate a new manifest as a generator.

If the generator does not receive the completed manifest from the treatment facility within fifty (50) days after the date the medical waste was accepted by the transporter, the generator must report this fact to the secretary.

On-site Treatment Requirements

There are three approved methods for infectious waste treatment (incineration, steam treatment, and discharge liquids to a sanitary sewer system. Also, alternative methods of treatment can be used if they have been approved in writing by the Department of Health and Human Resources. The following is a brief overview of the three approved methods (consult Title 64, Series 56-10 for details):

• Incineration.
  • All incinerators must be registered with the Department of Health and Human Resources.
  • All the waste must be subjected to a minimum burn temperature of 1400EF for at least one hour.
  • The incinerator must be equipped with certain controls and monitoring devices to assure proper operation.
  • All combustible waste must be into ash that is not recognizable.
• Steam Treatment.
• The unit must maintain a temperature of 250EF for 90 minutes at 15 pounds per square inch gauge (psig) or one of several alternative operational set of conditions.
• Each package of infectious medical waste to be treated with steam shall have a tape attached that will indicate if the steam treatment temperature has been reached.
• Steam treatment units shall be evaluated under full loading for effectiveness with spores of Bacillus stearothermophilus no less than once per every forty (40) hours of operation.
• An operational log must be kept at each steam treatment unit that is complete for the preceding three (3) year period.
• Sanitary Sewer.
  • Liquid infectious medical waste may be discharged to a sanitary sewer through a drainage fixture.
  • The use of a grinder to reduce infectious solid matter to a size or consistency which can be discharged to a sewer is prohibited.

OSHA Regulations

In addition to the state medical waste environmental regulations there are some Occupational Safety and Health Administration (OSHA) rules that apply to medical/infectious waste.  West Virginia is one of 26 states covered entirely by the federal OSHA program.  This program is operated by the Occupational Safety and Health Administration.  OSHA rules (Occupational Exposure to Bloodborne Pathogens Standards) impact various aspects of medical/infectious waste, including management of sharps, requirements for containers that hold or store medical/infectious waste, labeling of medical/infectious waste bags/containers, and employee training. 

More Information

In this section, you will find links to points of contacts at the West Virginia State agencies responsible for regulating healthcare facility waste, links to the text of the regulations, and additional resources that you might find of interest on this topic.

Contacts

West Virginia Infectious Medical Waste Program Contacts

Statutes, Regulations and Guidelines

Infectious Medical Waste, Legislative Rule Division of Health, Department of Health and Human Resources, Title 64 Series 56

Infectious Medical Waste Incinerator rule (Title 45, Series 24)

Additional Resources

West Virginia Infectious Medical Waste Program Home Page

Applications and Forms for Medical Waste Generators