BIOHAZARDOUS/BIOMEDICAL WASTE MANAGEMENT

The purpose of this procedure is to provide guidance and describe requirements for the proper management of potentially infectious materials and waste products. Requirements for generators of infectious waste are prescribed in the California Code of Regulations, CCR Title 8, Sec's 3202 &5193, 29CFR 1910.1030, and San Diego County Ordinance No. 7476. Implementation of this program will ensure that all infectious wastes generated by CSUSM facilities and activities are managed in consonance with good health and safety practices and in compliance with applicable regulations.

San Diego County Department of Health Services has been assigned program responsibility for biohazardous/biomedical waste policy by the California Department of Health Services.

DEFINITION OF TERMS

BIOMEDICAL WASTE means any waste which is generated or has been used in the diagnosis, treatment or immunization of human beings or animals, in research pertaining thereto, in the production or testing of biologicals, or which may contain infectious agents and may pose a substantial threat to health. Biomedical waste does not include hazardous waste (as defined in California Code of Regulations Title 22, Division 4.5) or radioactive waste (as defined in CCR Title 17, subchapter 4).

BIOHAZARDOUS WASTE means any of the following:

1. Laboratory waste, including but not limited to, specimen cultures from medical and pathological laboratories, cultures and stocks of infectious agents from research and industrial laboratories, wastes from the production of biological agents, discarded live and attenuated vaccines, and culture dishes and devices used to transfer, inoculate and mix cultures or material which may contain infectious agents and may pose a substantial threat to health. All non-sterilized cultures shall be presumed to be biohazardous.

2. Any specimens sent to a laboratory for microbiologic analysis shall be presumed to be biohazardous.

3. Surgical specimens including human or animal parts or tissues removed surgically or by autopsy shall be presumed to be biohazardous.

4. Recognizable fluid blood elements and regulated body fluids, and containers and articles contaminated with blood elements or regulated body fluids that readily separate from the solid portion of the waste under ambient temperature and pressure. Regulated body fluids are cerebrospinal fluid, synovial fluids, pleural fluid, peritoneal fluid, pericardial fluid, and amniotic fluid.

5. Sharps, including any objects or devices having acute rigid corners, edges, or protuberances capable of cutting or piercing, and including, but is not limited to, hypodermic needles, blades, microscope slides and slip covers.

6. Contaminated animal carcasses, body parts, excrement and bedding of animals including materials resulting from research production of biologicals, or testing of pharmaceuticals which are suspected of being infected with a disease communicable to humans.

7. Any specimens sent to a laboratory for microbiologic analysis.

8. Surgical specimens including human or animal parts or tissues removed surgically or by autopsy or necropsy.

9. Such other waste materials that result from the administration of medical care to a patient by health care providers and are found by the administering agency, the Department of Environmental Health, or the local Health Officer to pose a threat to human health or the environment. If there is a difference in opinion between the administering agency, the Department of Environmental Health and/or the local Health Officer, the local Health Officer's view will prevail.

All of the above listed items, except sharps, are considered putrefying waste and should be stored in the waste freezer located in room 3-102.

MEDICAL SOLID WASTE shall include, but not be limited to, waste such as empty specimen containers, bandages or dressings containing non-liquid blood, surgical gloves, treated biohazardous waste, and other materials which are not biohazardous.

These items will be treated as non-putrefying waste. This class of biomedical waste can be stored in the labeled waste container.

SHARPS CONTAINERS AND RED BAGS--ADDITIONAL REQUIREMENTS:
All sharps containers are leakproof, rigid, puncture-resistant containers which when sealed cannot be reopened without great difficulty. These containers must be labeled with either "biohazard" or "infectious waste" on the outside of the container. These containers must also be labeled so that the producer's name, address and phone number are legible and easily visible on the outside of the container.In addition, all generators of biohazardous wastes shall meet the following requirements:

1. All sharps containers and red bags shall be labeled prior to placing any material in said containers or bags.

2. When wastes are to be processed in an autoclave prior to disposal by the generator they may be placed in a single red bag which must be placed in a clear autoclave bag which is labeled in the same manner as required for red bags. More than one red bag may be placed in an autoclave bag.

3. Wastes which are not processed in an autoclave prior to disposal by the generator shall be stored and disposed of in a red bag which is sealed inside of a second red bag.

4. Needles and syringes shall not be clipped prior to disposal.

5. Red bags, as defined above, shall be used only for the storage and disposal of biohazardous wastes.

6. All materials disposed of in sharps containers shall be managed in the manner prescribed for biohazardous wastes, whether or not the materials are actually biohazardous wastes.

BIOHAZARDOUS WASTE SIGN is:
In English,
"CAUTION-BIOHAZARDOUS WASTE STORAGE AREA - UNAUTHORIZED PERSONS KEEP OUT",
and in Spanish,
"CUIDADO - ZONA DE RESIDUOUS (INFECTADOS) PROHIBIDA LA ENTRADA A PERSONAS NO AUTORIZADAS".
Warning signs will be posted inside the waste storage site so that anyone entering this site will be aware of the hazard present.

RED BAG: Means a disposal plastic bag which is impervious to moisture and has a strength sufficient to preclude ripping, tearing or bursting under normal conditions of usage and handling of the waste-filled bag. Each bag shall be constructed of material of sufficient single thickness strength to pass the 165-gram dropped dart impact resistance test as prescribed by Standard D 1709-75 of the American Society for Testing and Materials and certified by the bag manufacturer. The bags shall be securely tied so as to prevent leakage or expulsion of solid or liquid wastes during storage, handling or transport. The bag shall be red in color and conspicuously labeled with the international biohazard symbol and the word "Biohazard". The bag shall be labeled so that the producer's name, address, and phone number are legible and easily visible on the outside of the bag.

PERMITTED BIOHAZARDOUS WASTE HAULER is a hauler who has received a permit from the appropriate agency to haul biohazardous waste. CSUSM will utilize only permitted biohazardous waste haulers to carry biohazardous waste off campus.

SOLID WASTE HAULER is a hauler licensed by the appropriate agency to haul solid waste (non-hazardous general trash).

PUTRESCIBLE BIOHAZARDOUS WASTE means biohazardous waste subject to decomposition by microorganisms which produce a foul order. Putrescible biohardous waste includes, but is not limited to, blood and urine specimens and cultures. This class of waste will be stored in the biohazardous marked freezer in room 3-102.

RESPONSIBILITIES

Supervisors managing activities which generate biohazardous/biomedical wastes (e.g., Principal Investigators, Lab Supervisors) are responsible for:

1. Assuring biohazardous/biomedical wastes are stored, handled, and disposed of according to this procedure. This includes segregation of putrefying and non-putrefying waste.

2. Training employees under their supervision on the proper handling and storage of biomedical materials.

3. Maintaining records of employee training. See IIPP for necessary forms to record training.

4. If wastes are sterilized prior to disposal in an autoclave, the department will maintain up-to-date documentation of standard operating procedures, including annual thermometer calibrations and monthly application of Bacillus stearothermophilus (a biological indicator), for each autoclave or other approved sterilization device.

Environmental Health & Safety is responsible for:

1. Developing campus requirements and guidelines, for biohazardous/biomedical waste which are consistent with applicable Federal, State and local regulations and guidelines.

2. Preparing, documenting, and coordinating the implementation of the University's Biomedical Waste Management Plan, in accordance with San Diego County Ordinances and California Health and Safety Codes, and obtaining the necessary permits to store and transfer biomedical waste.

3. Approving specific on-site treatment and procedures (e.g., autoclaving or other approved sterilization techniques) used to render biomedical waste noninfectious.

4. Performing audits of specific waste generating facilities or activities to assess compliance with this procedure.

5. Provide specific training to housekeeping personnel and supervisors as needed.

6. Act as contract manager for biomedical waste disposal and storage.

PROCEDURES

CONTAINMENT AND STORAGE

Biohazardous/biomedical material must be securely contained within Infectious Waste Bags ("Red Bags") according to the following:

1. Biohazardous/biomedical waste must be segregated from other types of waste at the point of origin. Putrefying waste must be separated from non-putrefying waste.

2. Biomedical waste must be "double-bagged" in individually sealed disposable plastic bags which are impervious to moisture, and have a strength sufficient to preclude ripping, tearing or bursting under normal handling conditions.

3. Bags containing biohazardous/biomedical waste must be red in color, and be labeled either as "Infectious Waste," or with the international symbol and the word "Biohazard."

4. Bags and sharps containers must be leak proof, puncture and tear resistant. RM&S will provide guidance in purchasing the correct bags and containers.

5. Bags must be securely tied so as to prevent leakage or expulsion of the contents during handling, transportation, or storage.

6. Bags must be labeled with generator name, CSU San Marcos, phone number (760)750-4510, and RM&S. Place the label on the outside of bag.

7. Any spill or leak of a medical/infectious waste must be decontaminated by appropriate procedures. Personnel performing these functions must practice universal precautions and use the correct clean-up materials. Assistance on proper cleaning materials is available from RM&S.

8. Rooms 3-102 and 3-122 are the pathological waste storage area at CSUSM. Inside this room there are marked biomedical waste containers. Identified non-putrefying waste is to be placed in the storage containers marked non-putrefying. Putrefying waste is to be double bagged and placed within the freezer marked "Caution - Biohazardous Waste Storage Area - Unauthorized Persons Keep Out." The freezer door is to be kept locked at all times. The waste will be removed from this room by the contractor.

Sharps, such as used needles, syringes, disposable pipettes, microscope slides or other objects having acute rigid corners or protuberances capable of cutting or piercing, shall be placed in containers which meet the following requirements:

1. Container must be leak proof, rigid, puncture resistant, and tightly lidded or taped closed to prevent loss of contents and to secure for disposal.

2. Container, once sealed, should not be reopenable without great difficulty.

3. Sharps containers must be labeled in the same way as infectious waste bags, or be placed in infectious waste bags.

4. Needle and syringe tips shall not be clipped prior to disposal.

5. Needles and syringes shall not be recapped. The entire unit shall be immediately placed in an approved sharps container after use.

6. When a sharps container is 3/4 filled, a new container should be placed into use and the old container sealed and moved to Rooms 3-102 or 3-122 for storage by RM&S personnel.

Use of Secondary Containers

1. All disposable infectious waste bags and sharps containers must be placed in secondary containers such as pails, cartons, drums, dumpsters, or bins for storage.

2. Secondary containers must be leak proof, have tight-fitting covers, and be kept clean and in good repair.

3. Secondary containers must be labeled on the lid and sides with the words, "Infectious Waste," or with the international biohazard symbol and the word, "Biohazard."

4. Reusable secondary containers must be easily cleanable, and must be washed and decontaminated each time they are emptied, unless they have been completely protected from contamination. The cleaning method should be approved by RM&S for compliance with applicable State and local regulations.

5. Secondary containers are to be sealed when they become 3/4 filled.

Storage enclosures for bagged infectious waste must be secured to deny access to unauthorized personnel and posted in both English and Spanish as follows:

CAUTION - INFECTIOUS WASTE STORAGE AREA - UNAUTHORIZED PERSONS KEEP OUT.

CUIDAD - ZONA DE RESIDUOS INFECTADOS - PROHIBIDA LA ENTRADA A PERSONAS NO AUTORIZADAS.

The posting is inside the room immediately in front of the door.

Putrefying biohazardous/biomedical waste shall not be stored in CSUSM facilities for more than:

1. Seven days at temperatures above of 0° C (32° F).

2. Six months at temperatures below 0° C.

DISPOSAL OF BIOHAZARDOUS/BIOMEDICAL WASTE
Biohazardous/biomedical waste amounts shall not exceed the permit limit of 220 pounds. Biohazardous/biomedical waste generated by the University must be disposed of by one of the following means:

1. Autoclave using operating procedures approved by RM&S.

2. Other sterilization techniques provided that approval is obtained from RM&S.

3. Transferred off-campus by a registered hauler for disinfection at a State-approved autoclave or incinerator.

4. In some cases, discharge into the sanitary sewer system may be acceptable for liquid, non-laboratory products. However, this type of disposal is discouraged unless the waste has been autoclaved before disposal.

Recognizable human anatomical remains must be disposed of by off-campus crematorium or internment at authorized facilities. Prior to generating this type of waste, the generator will contract with a mortuary for these services.

DISPOSAL CONTRACT
Advanced Chemical Transport is currently under contract to dispose of all CSUSM biomedical waste at their permitted facility. The contractor will collect biohazardous/biomedical wastes for disposal on call from RM&S only. The contractor shall ensure that all sharps containers and all double-bagged biomedical waste will be autoclaved, all animal carcasses will be incinerated, and all services are performed in strict accordance with applicable Federal, State, and local regulations. RM&S will manage this contract and should be contacted at 750-4510 for any problems with this service. ONLY RM&S will contact the disposal contractor. 

AUTOCLAVING
Sterilization by heating in a steam sterilizer (autoclave), so as to render the waste noninfectious, may be a method used at CSUSM to treat biomedical waste before disposal. Biohazardous/biomedical waste rendered noninfectious may be disposed of as solid waste if it does not contain any other hazardous properties. Sharps containers may not be disposed of as solid waste. Operation of steam sterilizers shall be in accordance with the following:

1. When wastes are to be autoclaved prior to disposal, they must be placed in a single Red Bag which must in turn be placed in an autoclaveable bag which is labeled in the same manner required for Red Bags. The bags are to be placed in a container that is impervious to autoclaving.

2. A written standard operating procedure (SOP) for each steam sterilizer should be prepared and followed. SOP should include time, temperature, pressure, type of waste, type of container(s), closure on container(s), pattern of loading, water content, and maximum load quantity. Include the results of the biological testing in the sterilizer log. Autoclave must be calibrated annually.

3. Check of recording and/or indicating thermometers during each complete cycle to ensure the attainment of a temperature of 121° C (250° F) for one-half hour or longer, depending on quantity and compaction of the load, in order to achieve sterilization of the entire load. Thermometers shall be checked for calibration at least annually.

4. Use heat sensitive tape or other devices for each container that is processed to indicate the attainment of adequate sterilization conditions.

5. Use of the biological indicator Bacillus stearothermophilus placed at the center of a load processed under standard operating conditions at least monthly to confirm the attainment of adequate sterilization conditions.

6. Maintenance of records of procedures specified in (b), (c), and (e) above for period of not less than three years.

STORAGE AND DISPOSAL OF BIOHAZARDOUS/BIOMEDICAL SOLID WASTE 

Biohazardous/biomedical Solid Waste (i.e., medical waste which is or has been rendered noninfectious) shall be disposed of as follows:

The wastes will be placed in a trash receptacle or compactor. Such receptacle shall be protected to prevent access to the contents thereof by anyone other than authorized persons or refuse collection personnel.

For Further Information

Additional information on safe handling practices and associated requirements can be obtained from RM&S. Contact the RM&S Hazardous Materials Coordinator (X4502) for copies of applicable regulations or further information.