Ampro - American Medical Waste Professionals, LLC

American Medical Waste Professionals, LLC

616 South Fourth Street
Elkhart, Indiana 46516
Phone: 866.442.6776  Fax: 574.522.0374

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Infectious Waste Segregation Guidelines

INFECTIOUS WASTE SEGREGATION

GUIDELINES

PREPARED BY

AMERICAN MEDICAL WASTE PROFESSIONALS LLC

(AMPRO)

5/20/07

 

INFECTIOUS WASTE

 

Infectious waste means waste that epidemiologic evidence indicates is capable of transmitting a dangerous communicable disease (as defined in the Indiana State Department of Health regulations, 410 IAC 1-3-5). The term includes, but is not limited to:

 

1.    Pathological wastes, including tissue, organs, body parts, and blood or body fluids in liquid or semiliquid form that are removed during surgery, biopsy, or autopsy.

 

2.      Biological cultures and associated biologicals.

3.      Contaminated sharps.

4.      Infectious agent stock and associated biologicals.

5.      Blood and blood products in liquid or semi liquid form.

6.      Laboratory animal carcasses, body parts, and bedding.

7.      Infectious wastes as defined in the Indiana State Department of Health regulations (410 IAC 1-3-5).

8.      Other waste that has been intermingled with infectious waste.

Specific examples of these wastes include the following:

·        Saturated or grossly spoiled disposables (bloody gauze, dressings, lab pads, OB and surgical peri-pads and gloves

·        Containers, catheters or tubes with fluid blood or blood products not discarded or flushed (blood sets, suction canisters, and drainage sets)

·        Dialyzers and tubing

·        Microbiology specimens, used culture plates, tubes, bottles and devices

·         Blood spill clean up materials

·         Placentas and surgical specimens

 

PATHOLOGICAL WASTE

The following infectious waste should be further segregated and clearly marked “Must Incinerate” on all four sides of the container. See AMPRO representative to obtain the proper marking.

·        Pathological wastes consisting of consisting of recognizable body parts such as an amputated arm, leg, head or torso that may be of a size to not be properly treated by limited exposure to steam, could create and aesthetic concern for workers moving the bins of infectious that have been processed, or a potential concern at the landfill. Large animal carcasses should also  be labeled for incineration.

 

·        Antineoplastic waste or chemotherapy waste and any items trace-contaminated during the preparation or use of antineoplastic or chemotherapy drugs. Trace contaminated items include the following:

·                  Gowns

·                  Gloves

·                  Masks

·                  Barriers

·                  IV tubing

·                  Empty bags/bottles

·                  Empty drug vials

·                  Spill cleanup materials or kits

·                  HEPA filters from Pharmacy laminar air flow hoods

·                  Needles and syringes

 

·        Infectious waste form the treatment of variant Creutzfeldt - Jakob disease, Creuzfeldt-Jakob Disease, or Mad Cow Disease.

 

 


 


State of Indiana Regulated Medical Waste

Indiana

Infectious Waste

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;
  • 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.  These requirements can be found in the HERC section entitled OSHA Standards for Regulated Waste.

Statutes, Regulations and Guidelines

Indiana Infectious Waste Rule (Article 1, Rule 3)

Indiana Hospital/Medical/Infectious Waste Incinerator Rule

Contacts

Indiana Department of Environmental Management

 


State of Illinois Regulated Medical Waste

Illinois

Regulated
Medical Waste


Waste Categories

Illinois classifies solid wastes into two main categories: nonspecial waste and special waste.  Special wastes are further divided into four subcategories.  Below is a summary of the categorization scheme.

Nonspecial Waste.  Nonspecial wastes are generally not as harmful to people or the environment, so they are not regulated as special waste. Nonspecial wastes include garbage and commercial waste. These types of wastes are generally associated with offices, homes and restaurants, but also include clean packaging, landscape waste, clean machinery components and construction or demolition debris.

Special Waste.  Special waste includes potentially infectious medical waste (PIMW), industrial process waste, pollution control waste and hazardous waste. Because the mismanagement of these wastes may cause serious health or environmental problems, special waste may be regulated under one or more sets of regulations in addition to the regulations for nonspecial waste. Special permitting requirements may also apply.

  • Potentially infectious medical waste (PIMW) - includes most medical waste generated by health care professionals or medical research that may be infectious to humans.  It does not include medical waste generated at a household.
  • Industrial process waste - includes waste generated by industry or commercial services such as gas stations or painting contractors. Industrial process waste does not include clean packaging materials, office or food waste.
  • Pollution control waste - is generated by the treatment or cleanup of other wastes. Treatment residues from wastewater treatment, air scrubbing and spill cleanups are all pollution control waste.
  • Hazardous waste - is the most highly regulated category of waste. Some wastes are hazardous because of their ignitable, corrosive, reactive or toxic properties. These are called characteristically hazardous wastes. In other instances, U.S.EPA has decided that the waste produced by certain industrial activities will always be a hazardous waste. These are called listed hazardous wastes.

Definition of Potentially Infectious Medical Waste (PIMW)

Potentially Infectious Medical Waste (PIMW) is waste generated in connection with the diagnosis, treatment (i.e., provision of medical services), or immunization of human beings or animals; research pertaining to the provision of medical services; or the provision or testing of biologicals.

Managing Potentially Infectious Medical Waste

Segregation.  Generators must segregate potentially infectious medical waste (PIMW) as follows:

  • Sharps,
  • Oversized PIMW, and
  • All other PIMW.

PIMW mixed with other waste is regulated as PIMW.

Packaging.  PIMW, except for oversized PIMW, must be placed in a container, or a combination of containers.  Such container must be:

  • rigid;
  • leak-resistant;
  • impervious to moisture;
  • of a strength sufficient to prevent tearing or bursting under normal conditions of use and handling; and
  • sealed to prevent leakage during transport

Sharps, unless rendered unrecognizable, must be packaged in a container, or a combination of containers, that is puncture-resistant.

Oversized PIMW must be covered or packaged in a manner that minimizes contact with transport workers and the public.  Sharps must not be packaged with oversized PIMW in the same container.

If the outside of a container is contaminated by PIMW, a person must place the container inside another container, or clean and disinfect the container.

Once a reusable container has been cleaned and disinfected, it can be used for only waste.  If a reusable container is not or cannot be cleaned and disinfected, it must be regulated as PIMW pursuant to this Subtitle.

PIMW packages must not be compacted or subjected to stress that compromises the integrity of the container.

Labeling.  The following rules apply to healthcare facilities who package PIMW for off-site transportation.

The generator must mark the exterior of the outer package as follows prior to shipment:

  • Mark on two opposite sides of the outer package in lettering that is readable at a minimum distance of five (5) feet:
    • The International Biohazard Symbol as shown in Illustration A of this Part and the word "Biohazard"; and
    • The word "sharps", if the package contains sharps.
  • Mark with indelible ink in lettering that is legible on a water-resistant label or tag securely attached to or marked on the outer package:
    • The generator's name,
    • The generator's address, and
    • The generator's phone number (a 24-hour phone number, if available).

The transporter shall mark with indelible ink in lettering that is legible on a water-resistant label or tag securely attached to or marked on the outer package:

  • The transporter's name,
  • The transporter's permit number,
  • The transporter's address,
  • The transporter's phone number (a 24-hour phone number, if available), and
  • For each PIMW package, the shipment date when PIMW initially left the generator's site; or for each shipment, a unique identification number which directly corresponds to the initial date of shipment.

If a sharps container is packaged within an outer container, the inner sharps container must be marked with indelible ink in lettering that is legible as follows:

  • The International Biohazard Symbol as shown in Illustration A of this Part and the word "biohazard"; and
  • The word "sharps".

Containers which are not the inner or outer containers are exempt from the labeling requirements.  Packages may be placed in a transparent container provided that all required markings are legible through the transparent container.  A non-rigid transparent container cannot be used as an outer container.

For oversized PIMW, the following requirements must be met prior to shipment. 

  • The generator must mark on one side of the outer package in lettering that is readable at a minimum distance of five (5) feet the International Biohazard Symbol as shown in Illustration A of this Part and the word "biohazard".
  • The generator must mark with indelible ink in lettering that is legible on a water-resistant label or tag securely attached to or marked on the outer package:
    • The generator's name,
    • The generator's address, and
    • The generator's phone number (a 24-hour phone number, if available).

The transporter must mark with indelible ink in lettering that is legible on a water-resistant label or tag securely attached to or marked on the outer package:

  • The transporter's name,
  • The transporter's permit number,
  • The transporter's address,
  • The transporter's phone number (a 24-hour phone number, if available), and
  • For each PIMW package, the shipment date when PIMW initially left the generator's site; or for each shipment, a unique identification number which directly corresponds to the initial date of shipment.

Storage. The following rules are applicable to on-site storage of PIMW at healthcare facilities.  The storage requirements include:

  • Store the PIMW in a manner and location that maintains the integrity of the packaging and provides protection from water, rain, and wind.
  • Maintain the PIMW in a nonputrescent state, using refrigeration when necessary.
  • Limit access to on-site storage areas to authorized employees.
  • Store the PIMW in a manner that affords protection from animals and does not provide a breeding place or food source for vectors.
  • Multiple generators in the same building may store their PIMW packages in a common storage area.
  • Reusable PIMW containers or facility equipment (e.g., carts, squeegees or shovels) which are visually contaminated with PIMW must be cleaned in a designated area.

Transportation. PIMW can only be transported by a licensed PIMW hauler to a permitted transfer, storage, or treatment facility.  Once the PIMW has been treated and the sharps have been packaged properly, it can be placed in a landfill.

A special manifest must accompany all PIMW shipments coming into Illinois, within Illinois, and from Illinois to states not providing their own manifests.  The cost is $4.00 per manifest and must be paid by check, cashier’s check, or money order made payable to Treasurer, State of Illinois.  Any questions should be directed to 217/782-9293 or 217/785-8604.  A manifest request form can be found below under “More information”.  Allow 2 weeks for processing.

Treatment

Treatment facilities are those facilities designed and operated to treat PIMW to eliminate its infectious potential. Hospitals which treat only their own PIMW or that of their medical staff are not required to be permitted by the Illinois EPA. Treatment of PIMW must be conducted in a manner that:

  • Eliminates the infectious potential of the waste. A treatment process eliminates the infectious potential of PIMW if the manufacturer/owner/operator demonstrates that an Initial Efficacy Test (IET) and Periodic Verification Test (PVT) have been completed successfully. Refer to Sections 1422.124 and 1422.125 of the Act or the Fact Sheet on Testing Requirements for details on these tests.
  • Prevents compaction and rupture of containers during handling operations, except when this is an integral part of the treatment process;
  • Disposes of treatment residuals in accordance with all applicable regulations;
  • Provides for quality assurance programs that must include a written plan;
  • Provides for periodic testing using biological testing;
  • Provides for assurances that clearly demonstrate that PIMW has been properly treated; and is in compliance with all Federal and State laws and regulations pertaining to environmental protection.

Disposal

Untreated medical waste cannot be disposed of into any landfill. Untreated PIMW is banned from all landfills in Illinois. Once PIMW has been properly treated to eliminate its infectious potential, it is no longer PIMW (except in the case of sharps) and may be disposed of into any landfill permitted by the Illinois EPA to accept municipal waste. For sharps, both the infectious nature must be eliminated and the sharps must either be rendered unrecognizable or packaged in accordance with the regulations prior to disposal.

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.  Illinois 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.  These requirements can be found in the HERC section entitled OSHA Standards for Regulated Waste.

Statutes, Regulations and Guidelines

Title 35, Part 1420 - Potentially Infectious Medical Waste - General Provisions

Title 35, Part 1421 - Potentially Infectious Medical Waste - Activity Standards

Title 35, Part 1422 - Potentially Infectious Medical Waste - Design and Operation of Facilities