Regulated Medical Waste

Indiana

Infectious Waste

Background Information
Definition of Infectious Waste
Managing Infectious Waste
OSHA Regulations
Statutes, Regulations and Guidelines
Contacts
More Information

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 Waste

Infectious waste means waste that epidemiologic evidence indicates is capable of transmitting a dangerous communicable disease. The term includes, but is not limited to, the following:

Contaminated sharps or contaminated objects that could potentially become contaminated sharps;
Infectious biological cultures, infectious associated biologicals, and infectious agent stock;
Pathological waste;
Blood and blood products in liquid and semiliquid form;
Laboratory animal carcasses, body parts, blood and body fluids in liquid and semiliquid form;
Bedding of laboratory animals; and
Other waste that has been intermingled with infectious waste.

Managing Infectious Waste

This rule applies, without regard to quantity, to defined facilities and persons involved in infectious waste activity.

Containment and Labeling; Effective Treatment, Transport, or Disposal

The generator of infectious waste is responsible for the appropriate containment, appropriate labeling, effective treatment, transport, and disposal of infectious waste as required by this rule. A person may provide services to the generator of infectious waste, including the appropriate containment, appropriate labeling, effective treatment, transport, or disposal of infectious waste. Both the generator of infectious waste and the person providing services to the generator of infectious waste are responsible for complying with the requirements set forth in this rule.

Containment

All persons and facilities subject to the infectious waste rule shall:

Ensure that infectious waste is at all times contained in a manner that will reasonably protect waste handlers and the public from contracting dangerous communicable disease that may result from exposure to the infectious waste.
Place contaminated sharps or contaminated objects that could potentially become contaminated sharps, infectious biological cultures, infectious associated biologicals, and infectious agent stock in containers that are:
- Leak proof, rigid, puncture-resistant;
- Tightly sealed to prevent expulsion;
- Labeled with the biohazard symbol; and
- Effectively treated in accordance with this rule prior to being stored in an unsecured area and sent for final disposal.
Place pathological waste; laboratory animal carcasses, laboratory animal body parts, laboratory animal blood and body fluids, and laboratory animal bedding; human blood; human blood products in liquid or semiliquid form; and human body fluids that are visibly contaminated with blood in containers that are:
- Impervious to moisture;
- Sufficient strength and thickness to prevent expulsion;
- Secured to prevent leakage or expulsion;
- Labeled with the biohazard symbol; and
- Effectively treated in accordance with this rule prior to being placed in an unsecured area and sent for final disposal.

Storage Requirements

If infectious waste is stored prior to final disposal, all persons shall store infectious waste in a secure area that:

Is locked or otherwise secured to eliminate access by or exposure to the general public; and
Affords protection from adverse environmental conditions and vermin; and
Has a prominently displayed biohazard symbol.

In addition:

Stored in a manner that preserves the integrity of the container, and is not conducive to rapid microbial growth and putrefaction; and
Disinfect reusable containers for infectious waste each time that they are emptied, unless the surfaces of the reusable containers have been protected from contamination by disposable liners, bags, or other devices that are removed with the infectious waste.

Treatment of Infectious Waste

All persons and facilities subject to this rule shall either effectively treat infectious waste or transport infectious waste off-site for effective treatment.

A treatment is effective if it reduces the pathogenic qualities of infectious waste for safe handling, is designed for the specific infectious waste involved, and is carried out in a manner consistent with this rule. Effective treatment may include:

Incineration;
Steam sterilization;
Chemical disinfection;
Thermal inactivation;
Irradiation; or
Discharge in a sanitary sewer or septic system that is properly installed and operating in accordance with state and local laws.

Applicable persons and facilities may store, transport, and dispose of infectious waste that has been effectively treated in accordance with this rule in the usual manner for waste that is noninfectious.

Transporting Infectious Waste

All persons and facilities subject to this rule shall:

Transport infectious waste in a manner that reasonably protects waste handlers and the public from contracting dangerous communicable disease; and
Effectively treat infectious waste in accordance with this rule before it is compacted.

Transporting Infectious Waste Off-Site

All persons and facilities subject to this rule who are transporting infectious waste off-site, whether effectively treated or not, shall:

Mark containers of infectious waste with a label that states the name, address, and telephone number of the generating facility and treatment facility, if applicable; and
Provide a form that contains:
- The name, address, and telephone number of the generating facility and treatment facility, if applicable;
- A brief description of the waste and the method of effective treatment; and
- The signature of a responsible person.

Required information may be enclosed between the secondary packaging and the outer packaging, when such packaging is used. The outer packaging must contain a biohazard symbol.

Written Policies and Procedures, Reporting and Recordkeeping

All persons and facilities subject to this rule shall have written policy and procedures that, at a minimum, contain:

The requirements of the infectious waste rule; and
The sanctions, including discipline and dismissal of persons, if warranted, for failure to follow the requirements set forth in this rule;
Provide necessary instruction and materials, including protective garments, to implement this rule prior to giving a person an assignment where contact with infectious waste is likely;
Maintain a record of such instruction, including an attendance record of a person's participation in the instruction; and
Make all records available to the department for inspection

Facility Operator Responsibilities

Facility operators are responsible for informing employees and other applicable persons of the risk of HIV and other infections, and providing appropriate training and education. Detailed responsibilities are contained in the infectious waste rules.

Facility Operator Policies

A facility operator shall develop a written policy that requires the use of universal precautions by a covered individual when performing those professional, employment, training, or volunteer activities or duties that include any reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials. The policy shall also include:

Sanctions, including discipline and dismissal, if warranted, for failure to use universal precautions; and
Proscribes the facility operator, or any covered individual acting at or on behalf of the facility, from retaliating against any person, including any professional, employee, trainee, volunteer, or patient, for filing a complaint with the department in good faith under this rule.

Covered Individuals' Minimum Training and Certification Requirements

All covered individuals must complete the training programs which the facility is required to have employees attend under the Indiana occupational safety and health administration's bloodborne pathogens standards. Detailed instructions are contained in the infectious waste rules.

OSHA Regulations: HERC OSHA State Page

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. Indiana is one of 21 states operating an approved occupational safety and health program. This program is operated by the Indiana Occupational Safety and Health Division. 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.