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1. General Terms
1.1. Regulated Medical Waste (RMW)
1.1.1. RMW, also known as 'biohazardous waste” or “infectious waste”, is the portion of the wastestream that may be contaminated by blood, bodily fluids, or Other Potentially Infectious Materials (OPIM’s). Thus posing a significant risk of transmitting infection.
1.2. Biohazardous Waste
1.2.1. Biohazardous Waste, also known as “Regulated Medical Waste” or “infectious waste”, clinical waste, or biomedical waste that is a waste or reusable material derived from the medical treatment of a human. This includes the waste from an animal that is suspected by the attending veterinarian of being infected with a pathogen that is also infectious to humans. which includes diagnosis and immunization; or from biomedical research, which includes the production and testing of biological products.
1.3. Other Potentially Infectious Materials (OPIM’s)
1.3.1. Also known as “infectious waste”. The following human bodily semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid,pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids.
1.4. Sharps Waste
1.4.1. A device that has acute rigid corners, edges, or protuberances capable of cutting or piercing, including, but not limited to, hypodermic needles, hypodermic needles with syringes, blades, needles with attached tubing, acupuncture needles, root canal files, broken glass items used in health care such as Pasteur pipettes and blood vials contaminated with biohazardous waste, and any item
capable of cutting or piercing from trauma scene waste.
1.5. Sharps Container
1.5.1. A (UN3291) rigid puncture-resistant container used in patient care or research activities meeting the standards of, and receiving approval from, the United States Food and Drug Administration as a medical device used for the collection of discarded medical needles or other sharps.
1.6. Pharmaceutical Waste
1.6.1. “Pharmaceutical” means a prescription or over-the-counter human or veterinary drug, including, but not limited to, a drug as defined in Section 109925 of the Federal Food, Drug, and Cosmetic Act, as amended, (21 U.S.C.A. Sec. 321(g)(1)).
1.7. Pathology Waste
1.7.1. Human body parts, with the exception of teeth, removed at surgery. Surgery specimens or tissues removed at surgery or autopsy that are suspected by the health care professional of being contaminated with infectious agents known to be contagious to humans or having been fixed in formaldehyde or another fixative.
1.7.2. Animal parts, tissues, fluids, or carcasses suspected by the attending veterinarian of being contaminated with infectious agents known to be contagious to humans.
1.8. Trace Chemotherapeutic Waste
1.8.1. Waste that is contaminated through contact with, or having previously contained, chemotherapeutic agents, including, but not limited to, gloves, disposable gowns, towels, and intravenous solution bags and attached tubing that are empty.
1.8.2. The Medical Waste Management Act (PDF) (MWMA), Section 117705 of the California Health and Safety Code, considers any person whose act or process produces medical waste to be a “medical waste generator” in California (e.g., a facility or business that generates, and/or stores medical waste onsite).
1.8.3. Medical and dental offices, clinics, hospitals, surgery centers, laboratories, research laboratories, unlicensed health facilities, those facilities required to be licensed pursuant to Division 2 (commencing with Section 1200), chronic dialysis clinics, as regulated pursuant to Division 2 (commencing with Section 1200), and education and research facilities. Veterinary offices, veterinary clinics, and
veterinary hospitals. Trauma scene waste management practitioners.
1.8.4. Medical waste generators may be either large quantity generators (LQG = >200 lbs/month), or small quantity generators (SQG = <200 lbs/month). Medical waste generators shall register with their local enforcement agency.
2. Regulated Medical Waste (RMW) hauler, transfer station, and treatment facility:
2.1. Registered hazardous waste hauler/common carrier used to remove untreated medical waste.
2.1.1. San Diego Medical Waste Services, LLC
7630 Miramar Rd. Ste 2200
San Diego, CA 92126
P: 619-990-4604
Transporter Registration No: 6349
2.2. Offsite treatment facility to which medical waste is transported
2.2.1. San Diego Medical Waste Services, LLC via MET
1463 Fayette St.
El Cajon, CA 92020
P: 619-719-1508
3. Segregation, Packaging, and Disposal Procedures (All medical waste will be contained separately from other waste at the point of generation.)
3.1. Sharps
3.1.1. Segregation: Special precautions should be taken to prevent injury of infection to personnel handling these items. (See company Exposure Control Plan ECP) Discarding sharps directly in red biohazard liners is prohibited.
3.1.2. Packaging/Labeling: These items should be placed in an industry standard sharps container (Red, UN3291-RMW-6.2N.O.S. PGII), clearly labeled as infectious waste. Full sealed sharps containers may be included in red biohazard liners inside secondary biohazard container for collection, transport, treatment, and disposal.
3.1.3. Disposal: Steam sterilization at a permitted medical waste treatment facility or by other sterilization, in accordance with all of the following operating procedures for steam sterilizers or other sterilization. Recording or indicating thermometers shall be checked during each complete cycle to ensure the attainment of 121° Centigrade (250° Fahrenheit) for at least one-half hour, depending on the quantity and density of the load, to achieve sterilization of the entire load. Thermometers, thermocouples, or other monitoring devices identified in the facility operating plan shall be checked for calibration annually. Records of the calibration checks shall be maintained as part of the facility’s files and records for a period of two years or for the period specified in the regulations.
3.2. Infectious Waste
3.2.1. Segregation: Special precautions should be taken to prevent injury of infection to personnel handling these items. (See company Exposure Control Plan ECP)
3.2.2. Packaging/Labeling: Must be bagged, twisted, and sealed in the liners provided (Red, UN3291-RMW-6.2N.O.S. PGII). Care must be taken not to puncture liner. Do not force bags into secondary container as this could cause breakage or leakage. Do not stack red bags on top of container. Do not overfill liners so container cannot be closed, secured, and sealed for transport and disposal.
3.2.3. Disposal: Steam sterilization at a permitted medical waste treatment facility or by other sterilization, in accordance with all of the following operating procedures for steam sterilizers or other sterilization. Recording or indicating thermometers shall be checked during each complete cycle to ensure the attainment of 121° Centigrade (250° Fahrenheit) for at least one-half hour, depending on the quantity and density of the load, to achieve sterilization of the entire load.
3.3. Pathological Waste
3.3.1. Segregation: Pathology waste, as defined in paragraph (2) of subdivision (b) of Section 117690, shall be segregated for storage and, when placed in a secondary container, that container shall be labeled with the words “Pathology Waste,” “PATH,” or other label approved by the department on the lid and sides, so as to be visible from any lateral direction, to ensure treatment of the waste
pursuant to Section 118222.
3.3.2. Packaging/Labeling: Must be bagged, twisted, and sealed in the liners provided (Red, UN3291-RMW-6.2N.O.S. PGII). Care must be taken not to puncture liner. Do not force bags into secondary container as this could cause breakage or leakage. Do not stack red bags on top of container. Do not overfill liners so container cannot be closed, secured, and sealed for transport and disposal.
3.3.3. Disposal: Pathology waste of a human nature, as defined in subparagraph (A) of paragraph (2) of subdivision (b) of Section 117690, shall be disposed of by interment, incineration, or alternative treatment technologies approved to treat this type of waste, pursuant to paragraph (1) or paragraph (3) of subdivision (a) of Section 118215 of the MWMA.
3.4. Trace Chemotherapy Waste
3.4.1. Segregation: All trace chemotherapy waste will be packaged in rigid containers, clearly labeled as carcinogen or chemotherapy waste (Color-Coded Yellow). Carcinogen waste must be packaged and labeled separately and must be incinerated.
3.4.2. Packaging/Labeling: All trace chemotherapy waste will be packaged in a rigid container, YELLOW in Color (Yellow UN3291-NON-RCRA CHEMOTHERAPY-6.2N.O.S. PGII) and labeled “Incinerate Only”
3.4.3. Disposal: Trace chemotherapy waste that meets the conditions of paragraph (5) of subdivision (b) of Section 117690 shall be treated by incineration or alternative treatment technologies approved to treat that waste pursuant to paragraph (1) or paragraph (3) of subdivision (a) of Section 118215 prior to disposal.
3.5. Non-Hazardous Pharmaceutical Waste
3.5.1. Segregation: All Pharmaceutical Waste will be separated from Regulated Medical Waste (RMW).
3.5.2. Packaging/Labeling: (Blue/White UN3291-NON-RCRA PHARMACEUTICAL - 6.2N.O.S. PGII) Pharmaceutical Waste will be packaged in a rigid container (UN3291), clearly labeled as “Non-RCRA Pharmaceutical Waste” “Incinerate Only” (Color Coded White/Blue). Pharmaceutical Waste must be packaged separately and labeled “Incineration Only”.
3.5.3. Disposal: Pharmaceutical waste generated in California must be treated by incineration, or by an alternative treatment technology that has received approval from the Department. The technologies on the Department’s alternative medical waste treatment technologies list are the only alternative treatments approved for use in California. None of the charcoal-based products currently in use have gained this approval, so they must be disposed of in a pharmaceutical waste container. Do not place pharmaceuticals mixed with these products into the solid
waste.
3.6. Controlled Substances
3.6.1. Segregation: All “Controlled Substances” should be separated from all other waste streams and kept “locked up” until ready for reverse distribution.
3.6.2. Packaging/Labeling: See local DEA requirements and package I/A/W Secure and Responsible Drug Disposal Act of 2010
3.6.3. Disposal: Pharmaceutical wastes classified by the DEA as “Controlled Substances” must be disposed of in compliance with DEA requirements. The Department recommends the following process to make controlled substance waste non retrievable. Pills containing a controlled substance are crushed before placing the residue into a pharmaceutical waste container. Controlled substance that is remaining in a syringe is wasted into a pharmaceutical waste container before disposing of the syringe in a sharps container. Expired
medications should be returned through a reverse distributor. Under no circumstances should any waste medication – including controlled substance waste – be disposed of down the drain or into solid or biohazardous waste.
3.7. Mixed Waste
3.7.1. “Mixed waste” means mixtures of medical and nonmedical waste. Mixed waste is medical waste, except for all of the following:
3.7.1.1. Medical waste and hazardous waste is hazardous waste and is subject to regulation as specified in the statutes and Regulations applicable to hazardous waste.
3.7.1.2. Medical waste and radioactive waste is radioactive waste and is subject to regulation as specified in the statutes and regulations applicable to radioactive waste.
3.7.1.3. Medical waste, hazardous waste, and radioactive waste is radioactive mixed waste and is subject to regulation as specified in the statutes and regulations applicable to hazardous waste and radioactive waste.
3.7.2. In the event that any waste stream gets combined with another waste stream, both waste streams will be “upstreamed”, segregated, packaged, labeled and disposed of in accordance with the the most stringent requirements of each waste stream.
4. Safe Handling, Clean-up, Disinfection and Disposal of Single Spills.
4.1. Suggested Personal Protective Equipment (PPE)
4.1.1. Pair Disposable Gloves
4.1.2. Protective Gown
4.1.3. Absorbent Powder
4.1.4. Protective Mask with Eye-shield
4.1.5. Scoop with Detachable Scraper
4.1.6. Clear Disposal Bag
4.1.7. Bleach Towelette
4.1.8. Absorbent Towel
4.1.9. Twist Ties
4.1.10. Antimicrobial Hand Wipe
4.1.11. Biohazard Bag
4.2. Biohazard Spill Instructions:
4.2.1. Put on disposable gloves.
4.2.2. Open ziplock shaker pouch of absorbent powder and completely cover the spill (Caution, slippery when wet. Keep out of eyes. Do not inhale or ingest)
4.2.3. Once the spill is solidified, use the scoop and teachable scraper to pick up the spilled material.
4.2.4. Dispose of material, including empty powder shaker pouch and scoop, in provided biohazard bag.
4.2.5. Seal the biohazard bag with provided twist tie.
4.2.6. Thoroughly wet the pre-cleaned surface with the Bleach towelette and allow to remain wet for 4 minutes.
4.2.7. If needed, dry any remaining residue with the absorbent towel.
4.2.8. Dispose of all material, including gloves, in biohazard bag and secure with the provided twist tie.
4.2.9. Discard biohazard bag in appropriate Regulated Medical Waste container for infectious waste according to CDC/OSHA recommendations or your facilities guidelines.
4.2.10. Wash and wipe hands with antimicrobial hand wipe. Air dry.
5. Storage Requirements For Designated Medical Waste Accumulation Area
5.1. Designated Accumulation Area
5.1.1. A designated accumulation area used for the storage of medical waste containers prior to transportation or treatment shall be secured so as to deny access to unauthorized persons and shall be marked with warning signs on, or adjacent to, the exterior of entry doors, gates, or lids. The storage area may be secured by use of locks on entry doors, gates, or receptacle lids. The wording of warning signs shall be in English, “CAUTION—BIOHAZARDOUS WASTE STORAGE AREA—UNAUTHORIZED PERSONS KEEP OUT,” and in Spanish, “CUIDADO— ZONA DE RESIDUOS—BIOLOGICOS PELIGROSOS - PROHIBIDA LA ENTRADA A 50 PERSONAS NO AUTORIZADAS,” or in another language, in addition to English, determined to be appropriate by the infection control staff or enforcement agency. A warning sign concerning infectious waste, as that term was defined by Section 25117.5 as it read on December 31, 1990, that sign having been installed before April 1, 1991, meets the requirements of this section, until the sign is changed and as long as the sign is not moved. Warning signs shall be readily legible during daylight from a distance of at least
25 feet. Any enclosure or designated accumulation area shall provide medical waste protection from animals and natural elements and shall not provide a breeding place or a food source for insects or rodents.
6. Record Keeping for Medical Waste Generators
6.1. Medical Waste Container Labeling
6.1.1. Primary containers accumulating medical wastes, with the exception of bench top red bags used to collect non-breakable pipette tips, must be labeled with:
6.1.1.1. Generator’s Name, Address, Phone Number
6.1.2. Regulated Medical Waste (RMW) Record Keeping
6.1.2.1. All medical waste shipping documents and disposal records will be kept for a minimum of 3 years from the date of disposal regardless of being a Large Quantity Generator (LQG) or Small Quantity Generator (SQG)
6.1.3. Transporters of medical waste must provide generators with a copy (electronic) of a TRACKING DOCUMENT showing acceptance of the waste. This document must be kept for 3 years. The tracking document must contain all of the following:
6.1.3.1. Name and address of the transporter, generator, and the facility for medical waste treatment, storage, transfer or disposal.
6.1.3.2. Quantity (weight, volume and number of containers) of the medical waste.
6.1.3.3. Identification number attached to the bags or containers.
6.1.3.4. Date of medical waste collection.
7. Washing and Decontaminate Containers
7.1. A person shall thoroughly wash and decontaminate reusable rigid containers for medical waste by a method approved by the enforcement agency each time they are emptied, unless the surfaces of the containers have been completely protected from contamination by disposable liners, bags, or other devices removed with the waste. These containers shall be maintained in a clean and sanitary manner. Approved methods of decontamination include, but are not limited to, agitation to remove visible soil combined
with one of the following procedures:
7.1.1. Exposure to hot water of at least 82° Centigrade (180° Fahrenheit) for a minimum of 15 seconds.
7.1.2. Exposure to chemical sanitizer by rinsing with, or immersion in, one of the following for a minimum of three minutes:
7.1.2.1. Hypochlorite solution (500 ppm available chlorine).
7.1.2.2. Phenolic solution (500 ppm active agent).
7.1.2.3. Iodoform solution (100 ppm available iodine).
7.1.2.4. Quaternary ammonium solution (400 ppm active agent).