Health Care Department Operations Manual

Chapter 3 – Health Care Operations

Article 2 – Health and Safety

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3.2.1 Disposal of Regulated Waste Generated by Health Care Staff

Policy
- California Department of Corrections and Rehabilitation (CDCR) and California Correctional Health Care Services (CCHCS) shall safeguard the health and safety of its employees and patients by maintaining a system of internal control over the medical waste management process within CDCR institutions to ensure compliance with requirements under federal and state laws and regulations regarding medical waste containment, storage, disposal, and proper oversight of the Medical Waste Management Plan/Regulated Waste Local Operating Procedure. Waste generated by CDCR and CCHCS includes waste identified within both the Federal Resource Conservation and Recovery Act (RCRA) and the California Medical Waste Management Act.
Purpose
- To provide consistent management of waste generated by health care staff and to ensure CDCR and CCHCS compliance with federal, state and local requirements for safety and proper handling.
Responsibility
- Statewide
  - CDCR and CCHCS departmental leadership at all levels of the organization, within the scope of their authority, shall ensure administrative, custodial, and clinical systems are in place and appropriate tools, training, technical assistance, and levels of resources are available to support CDCR and CCHCS health care and contracted staff in the successful implementation and management of this policy and procedure.
- Institutional
  - RCRA and Non-RCRA Hazardous Waste
    - The Chief Executive Officer (CEO) and Warden, with the assistance of the institution fire chief or the hazardous materials (hazmat) coordinator have overall responsibility for proper disposal, containment, storage, labeling, tracking, and disposition of RCRA and non-RCRA hazardous waste generated by health care and contracted staff.
    - The CEO has overall responsibility for purchasing appropriately colored and sized United States (US) Department of Transportation (DOT) approved RCRA hazardous waste containers and hazardous waste container labels from a contracted or secondary vendor for use by health care and contracted staff.
  - Medical Waste
    - The CEO has overall responsibility for ensuring the implementation and enforcement of this procedure including, but not limited to:
      - Proper disposal, containment, storage, cleaning, sterilizing, labeling, tracking, movement, and disposition of medical waste by health care and contracted staff;
      - Purchasing of appropriately colored and sized containers from the contracted or secondary vendor, labels, signage, sterilization solutions approved under the California Medical Waste Management Act (MWMA), Personal Protective Equipment (PPE) and spill clean-up resources for use by health care and contracted staff;
      - Contracting with and scheduling of California Department of Public Health (CDPH) approved medical waste transporters;
      - Training of health care and contracted staff with documentation of this training retained at the institution for a minimum of two years; and,
      - Creation and maintenance of the institution’s Medical Waste Management Plan (MWMP) Regulated Waste Local Operating Procedure (LOP) Template, obtaining and maintaining required permits and licenses, auditing for health care service compliance, and maintenance of records as required within this procedure.
  - All institutional health care leadership as a part of the Quality Management process have overall responsibility to perform an ongoing review of the institutions’ MWMP including:
    - Overall quality of services;
    - Compliance with federal, state, local regulations, and this procedure;
    - Assignment of consistent and adequate resources;
    - Health care and contracted staff training; and,
    - Working with institutional staff to ensure the appropriate collection, transportation, and disposal of all waste covered by this procedure.
  - Health care and contracted staff shall comply with this procedure including, but not limited to:
    - Proper identification, separation, and disposal of the regulated waste generated by health care and contracted staff;
    - Proper use, storage, labeling, and transport of regulated waste containers;
    - Proper clean up of all regulated waste spills including use of PPE and clean-up supplies;
    - Maintenance of supplies within health care service areas for use in regulated waste disposal;
    - Completion of Regulated Waste Management training upon hire and at least annually thereafter; and,
    - Proper hazardous waste container use, satellite collection point management, waste storage, availability of supplies; completion of the Hazardous Waste Container Contents Log; black hazardous waste container labeling; and coordination with the institution fire chief or hazmat coordinator for hazardous waste container pick up.
Procedure
- Procedure Overview
  - The purpose of this procedure is to outline a consistent process for the disposal of waste generated by health care and contracted staff within all CDCR institutions.
- General Principles for Medical Waste Generated
  - The requirements for disposing of medical waste are found in the MWMA which does not include the requirements for RCRA and non-RCRA hazardous waste.
  - CDCR institutions shall not treat medical waste onsite. All medical waste shall be transported from the institution by the state-approved medical waste transporters to registered medical waste treatment facilities.
  - Each type of medical waste shall be contained separately from other waste from the point of generation. Refer to Management of Regulated Wastes Generated by Dental and Medical Practices.
  - Waste consisting of both medical and non-medical waste shall be treated as medical waste.
  - When RCRA hazardous waste is mixed with nonhazardous medical waste, the resulting waste shall be treated as RCRA hazardous waste.
  - For the purposes of this procedure, pathology waste shall be disposed of as biohazardous waste.
  - Each institution is responsible for obtaining appropriate sizes and colors for its medical waste containers. Medical waste containers and biohazard bags shall be obtained from the medical waste prime vendor. If identified medical waste containers or biohazard bags are not available through the prime vendor, the institution shall purchase medical waste containers or biohazard bags from a secondary source.
  - When a back-up medical waste transporter is necessary, the institution shall contract with a vendor from the CDPH medical waste transporter list available at the following link:
    http://www.cdph.ca.gov/Programs/CEH/DRSEM/Pages/EMB/MedicalWaste/Transporters.aspx
- Proper Disposal, Containment and Storage of Medical Waste Generated
  - Biohazardous Waste
    - All medical treatment areas shall have US DOT approved red biohazard bags that are marked by the manufacturer as having met the requirements of American Society for Testing Materials (ASTM) 1922 and ASTM 1709, and a US DOT approved properly labeled rigid biohazardous waste container.
    - Biohazard bags and containers shall be obtained from the CCHCS biohazardous waste disposal contractor(s). Information on the current CCHCS biohazardous waste disposal contractor(s) can be obtained by contacting the Acquisitions Management Section at: CDCR HCS Service Contract Requests.
    - The biohazardous waste container shall be stored in a soiled utility room/dirty room or other interim accumulation area. Any enclosure or interim 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.
      - The container for storage, disposal, or transport shall be rigid, leak resistant, have tight-fitting covers, be kept clean, and in good repair.
      - The container shall be labeled with the words “Biohazardous Waste” or with the international biohazard symbol and the word “BIOHAZARD” on the lid and sides so as to be visible from any lateral direction.
      - Containers prepared for transport offsite from the institution shall comply with US DOT requirements.
    - Biohazard bags shall not be reused.
    - Biohazardous waste shall be placed into a red biohazard bag (whose contents shall not exceed three pounds or one gallon) and tied at the point of generation, then immediately transported to the interim accumulation area (soiled utility room/dirty room) where the biohazardous waste container is located. Once tied, a biohazard bag shall not be placed on the floor, counter, or reopened for further collection. An empty red biohazard bag shall be used for each clinic day in which patient care is provided. All biohazard bags in use shall be tied off and removed from the clinic at the end of each clinic day.
    - When the biohazardous waste container lined with its own red biohazard bag is 3/4 full or has reached its maximum holding time [refer to (d)(3)(A)6.d below], the red biohazard bag within the biohazardous waste container shall be twisted and secured with a single knot.
      - Designated staff shall use a biohazardous waste transport container to transport the secured biohazard bag(s) to the medical waste accumulation area.
      - If the biohazard bag(s) are not already in the medical waste transporter’s biohazardous waste transport container, then the biohazard bag(s) shall be transferred into one so that it may be picked up for proper treatment by the transporter.
      - Rigid biohazardous waste containers shall be maintained in a clean and sanitary manner.
        
        Reusable rigid biohazardous waste containers shall be thoroughly washed and decontaminated by a method approved by the Local Enforcement Agency (LEA) 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.
        
        Health care and contracted staff shall ensure use of clean and sanitary biohazardous waste containers by utilizing one of the following options for decontamination of used containers:
        
        Used biohazardous waste containers may be replaced with new biohazardous waste containers.
        
        Biohazardous waste containers may be reused after sending to a contracted biohazardous waste treatment facility for decontamination.
        
        Biohazardous waste containers may be decontaminated onsite by health care and contracted staff or vendor. MWMA approved methods of decontamination include, but are not limited to, agitation to remove visible soil combined with one of the following procedures:
        
        Exposure to hot water of at least 82° C (180° F) for a minimum of 15 seconds.
        
        Exposure to chemical sanitizer by rinsing with, or immersion in, one of the following for a minimum of three minutes:
        
        Hypochlorite solution (500 ppm available chlorine)
        
        Phenolic solution (500 ppm active agent)
        
        Iodoform solution (100 ppm available iodine)
        
        Quaternary ammonium solution (400 ppm active agent)
      - Maximum holding times are as follows:
        
        If the institution generates 20 or more pounds of the combined total poundage consisting of both biohazardous and sharps waste per month, the institution shall not contain or store the waste above 0° C (32° F) onsite for more than seven calendar days without obtaining prior written approval of the LEA.
        
        If the institution generates less than 20 pounds of the combined total poundage consisting of both biohazardous and sharps waste per month, the institution shall not contain or store the waste above 0° C (32° F) onsite for more than 30 calendar days without obtaining prior written approval of the LEA.
    - Suction canisters shall be placed in a red biohazard bag when ready for disposal, securely tied and placed into the biohazardous waste container. Do not use/add a solidifier prior to disposing of it into a red biohazard bag.
    - No syringes or other sharps are to be placed in a biohazard bag regardless of the presence of blood. All sharps shall be placed in an appropriate sharps container.
  - Sharps Waste
    - All emptied sharps (e.g., needles, syringes, broken glass vials, broken ampules, blades, etc.) are deposited into a sharps waste container. Any syringe, ampule, carpuject or other sharp which still contains medication shall be disposed of in either a RCRA hazardous waste container or a sharps waste container marked as “Incineration Only” on all four visible sides and top depending upon the classification of the medication that it contains.
    - When the container is 3/4 full or has reached the manufacturer’s full line indicated on the sharps waste container, the container shall be tightly closed or taped shut to prevent loss of contents prior to disposal. Once the sharps container has been closed, it shall be removed from the institution within the sharps holding time specified in (d)(3)(B)8.
    - Once sealed, sharps containers shall be transported to the medical waste accumulation area.
    - Once transported to the medical waste accumulation area, sharps containers shall be segregated from other types of waste containers and placed on the floor of the storage area for the medical waste transporter to pick up.
    - Only health care and contracted staff shall handle sharps containers, unless already sealed. Incarcerated workers shall only handle sharps containers once sealed and under direct visual supervision of health care and contracted staff.
    - Standing installation height for fixed sharps containers shall be 52”-56”.
    - Sharps shall never be placed directly into a red biohazard bag.
    - Sharps Holding Times
      - Once sealed, the maximum length of time the sharps container may remain at the institution depends on the total amount of medical waste generated by the institution. Assuming storage above
        0˚ C (32˚ F):
        
        If the institution generates 20 or more pounds of the combined total pounds consisting of both biohazardous and sharps waste per month, the sharps containers shall be picked up from the institution within seven calendar days of closing the containers.
        
        If the institution generates less than 20 pounds of the combined total pounds consisting of both biohazardous and sharps waste per month, the sharps containers shall be picked up within 30 calendar days of sealing the containers.
  - Pharmaceutical Waste
    - Introduction to Pharmaceutical Waste
      - When health care and contracted staff is uncertain as to the correct waste container, staff shall refer to the CDCR/CCHCS drug formulary for disposal guidance. If the medication is not listed on the drug formulary, refer to the state provided resource, PharmE® Waste Wizard® at the following link: https://www.pharmecology.com/Landing, prior to disposing of the medication. If the drug formulary or PharmE® Waste Wizard® instructs the staff to place the item in a black hazardous waste container, health care and contracted staff shall refer to the disposal of RCRA and non-RCRA hazardous pharmaceutical waste section of this procedure for further instructions.
      - Health care and contracted staff shall ensure compliance with HIPAA requirements prior to disposing of pharmaceutical waste containing patient information into a waste container. It is the responsibility of the health care and contracted staff disposing of the waste to remove any Protected Health Information from the package.
      - Each institution shall take steps to categorize generated pharmaceutical waste to ensure its separation into:
        
        Nonhazardous pharmaceutical waste (also known as California hazardous pharmaceutical waste, blue container)
        
        Trace chemotherapy waste (also known as compatible hazardous pharmaceutical waste, yellow container)
        
        RCRA and Non-RCRA hazardous waste (black containers with a separate container for each of the following):
        
        RCRA solids (pills, topical creams/ointments, applicators).
        
        RCRA liquids (topical lotions, orals, injectables).
        
        RCRA inhalants (ammonia ampules).
        
        Specifically identified hazardous substances (e.g., silver nitrate sticks, ethyl chloride). Each product shall be collected in its own black container.
        
        Non-RCRA hazardous inhaler canisters (e.g., pressurized aerosol hydro-fluoroalkane-HFA containers).
        
        Non-RCRA universal hazardous waste (e.g., dental amalgam).
    - Disposal of Nonhazardous Pharmaceutical Waste
      - All solid dosage forms of medications not otherwise identified as belonging to RCRA hazardous waste classes shall be disposed of as nonhazardous pharmaceutical waste.
      - All oral and injectable liquid dosage forms of medications not otherwise identified as belonging to RCRA hazardous waste classes shall be disposed of as nonhazardous pharmaceutical waste.
      - Liquid medications shall never be poured/squirted down a drain or flushed down a toilet. The exception is the disposal of manufactured bulk intravenous (IV) solutions of D5W, NaCl, lactated ringers, or any combination of these which shall be disposed of by pouring down a sewer or drain. For any IV solution containing elements other than the above, refer to the applicable portion of this procedure for the disposal instructions of the medication contained within.
      - IV or irrigation tubing used to administer nonhazardous pharmaceuticals that has residual medication shall be deposited into a blue pharmaceutical waste container.
      - Syringes, tubexes, carpujects, carpules, or other pharmaceutical sharps with residual (pourable) medication shall be disposed of in a red sharps waste container marked as “Incineration Only” on all four visible sides and top. Liquid medication shall not be ejected from the syringe/needle/vial into the drain or blue pharmaceutical waste container [refer to exception for Drug Enforcement Administration (DEA) controlled substances indicated in Section (d)(3)(C)2.f.3) below.
      - Pharmaceutical waste classified by the DEA as “controlled substances” is disposed of in compliance with DEA requirements and pursuant to the Health Care Department Operations Manual (HCDOM), Section 3.5.9, DEA Schedule II-V Controlled Substances.
        
        Pursuant to DEA requirements, proper disposal of a controlled substance requires the substances be made “non-retrievable.” Therefore, proper disposal of an institution’s controlled substances includes the following:
        
        Controlled substances in pill form shall be crushed and removed from unit dose packaging prior to being disposed of in the blue pharmaceutical waste container.
        
        Liquid or injectable controlled substances that are partial doses, spillage, or leaking containers shall be emptied into the blue pharmaceutical waste container and empty containers shall be placed into the blue pharmaceutical waste container. Empty syringes shall be placed into a sharps container for destruction.
        
        Alternative products (e.g., Cactus Sink® and Rxdestroyer®) satisfy the requirement for making controlled substances “non-retrievable.” However, these products shall be disposed of following the same requirements as a blue pharmaceutical waste container.
        
        Pursuant to the HCDOM, Section 3.5.9, DEA Schedule II-V Controlled Substances, controlled substance disposal shall be witnessed and the Inventory Control Method signed by two of the following in any combination: licensed nursing staff, pharmacists, or health care providers. The individual witnessing the destruction shall be present while the medication is being added to the blue pharmaceutical waste container.
        
        For controlled substances originally removed from an Automated Dispensing Cabinet (ADC), the health care and contracted staff wasting the dose and the witness observing the disposal shall record the disposal on the ADC.
        
        Controlled substances waste shall be limited to contaminated and partial doses only. Complete doses no longer necessary shall be returned to pharmacy for appropriate re-dispensing and expired medications shall be returned to pharmacy for reverse distribution.
      - Handling of Blue Pharmaceutical Waste Containers
        
        Pharmaceutical waste containers shall be labeled “Incineration Only” on all four visible sides and the top. Pharmaceutical waste containers shall have an accumulation start date written on the label once the first medication is added to it.
        
        Pharmaceutical waste holding times:
        
        A pharmaceutical waste container currently in use shall be replaced prior to one year from the date of first use, or when the container is 3/4 full (or the contents has reached the manufacturers fill line), whichever comes first.
        
        Containers ready for disposal shall be kept at the institution less than 90 calendar days. Institutions shall include the 90 calendar days permitted for storage at the medical waste accumulation area as part of the one year. Therefore, all containers shall be sealed and taken to the medical waste accumulation area no later than calendar day 275 from the accumulation start date.
        
        Sealed blue pharmaceutical waste containers shall be moved to the medical waste accumulation area and placed on the floor of the storage area for pick- up by the medical waste transporter. Blue pharmaceutical waste containers shall not be placed into red biohazard bags or biohazardous waste containers. Pharmaceutical waste shall not be combined with other regulated medical waste and shall be distinctly segregated from other types of waste in the medical waste accumulation area.
        
        Pharmaceutical waste that has separate accumulation areas from medical waste shall be maintained in a secure manner to protect the pharmaceutical waste contents from access by unauthorized individuals. Any suspected or confirmed tampering of, unauthorized access to, or loss of this pharmaceutical waste shall be reported pursuant to Section 3.5.26, Break-in, Theft/Loss from Pharmacy or Medication Storage Areas.
    - Disposal of Trace Chemotherapy Waste (yellow container or co-mingled with chemotherapy waste in a black container).
      - In order for containers that held chemotherapy drugs to be considered trace chemotherapy waste, they must be California Hazardous Empty.
      - As part of an institution’s LOP, health care staff shall assess their chemotherapy usage and specify whether the trace chemotherapy waste should be placed in black chemotherapy hazardous waste containers or yellow trace chemotherapy waste containers. The following elements shall be considered when making the decision:
        
        Quantity of chemotherapeutic agents used.
        
        Impact of increased cost of hazardous waste disposal for black chemotherapy containers.
        
        Determination of use at each location within the institution.
      - When an institution chooses to co-mingle trace chemotherapy waste with chemotherapy waste, it shall not contain:
        
        A controlled substance.
        
        IV tubing where the potential of bloodborne pathogens exist.
        
        A medication classified as a waste requiring special handling pursuant to MWMA.
        
        Sharps.
      - When yellow trace chemotherapy waste containers are 3/4 full or have reached their maximum holding time, the containers shall be sealed and moved to the medical waste accumulation area.
      - Trace chemotherapy waste maximum holding times:
        
        If 20 or more pounds of trace chemotherapy waste is generated per month, the institution shall not store the waste onsite for more than seven calendar days above 0° C (32° F).
        
        If less than 20 pounds of trace chemotherapy waste is generated per month, the institution shall not store the waste onsite for more than 30 calendar days above 0° C (32° F).
    - Disposal of RCRA and non-RCRA hazardous pharmaceutical waste (black container).
      - Unknown waste is presumed to be RCRA hazardous waste unless otherwise determined. Waste is determined to be hazardous due to any of the following criteria:
        
        Ignitability
        
        Corrosivity
        
        Reactivity
        
        Toxicity
        
        Or otherwise specifically listed as hazardous
      - Once waste is determined to be hazardous requiring disposal in a black hazardous waste container (refer to CDCR/CCHCS drug formulary or the PharmE^® Waste Wizard^® for assistance), the waste must be separated into different black waste containers based upon the following:
        
        RCRA solids (pills, topical creams/ointments, applicators).
        
        RCRA liquids (topical lotions, orals, injectables).
        
        RCRA inhalants (ammonia ampules).
        
        Specifically identified hazardous substances (e.g., silver nitrate sticks, ethyl chloride). Each product shall be collected in its own black container.
        
        Non-RCRA hazardous inhaler canisters (pressurized aerosol hydro-fluoroalkane-HFA containers)
        
        Non-RCRA universal hazardous waste (dental amalgam).
      - Non-RCRA Hazardous Inhaler Canisters (pressurized aerosol hydro-fluoroalkane-HFA containers) shall be disposed of as follows:
        
        Black non-RCRA hazardous waste containers containing exclusively MDIs shall be marked “Inhalers Only.” Powdered inhalants such as Advair®, Respimat®, or inhalant capsules are not included as hazardous waste and shall be disposed of in blue pharmaceutical waste containers.
        
        All inhaler canisters shall be removed from the plastic mouthpiece prior to placing in the black non-RCRA hazardous waste containers marked “Inhalers Only” with the mouthpiece being disposed of in regular trash.
        
        An “Inhalers Only” black non-RCRA hazardous waste container is the only hazardous waste container that does not require a Hazardous Waste Container Content Log.
        
        All black “Inhalers Only” waste containers require a hazardous waste label.
      - With the exception of “Inhalers Only” black non-RCRA hazardous waste containers, all black hazardous waste containers shall have a Hazardous Waste Container Contents Log. When health care and contracted staff place a substance in the black container, it shall be entered on the Hazardous Waste Container Contents Log.
      - Each black hazardous waste container shall continue in use up to the maximum accumulation time. Maximum accumulation times are as follows:
        
        Large quantity generators (RCRA) can accumulate RCRA hazardous waste up to 90 calendar days.
        
        Small quantity generators (RCRA) can accumulate RCRA hazardous waste up to 180 calendar days at a satellite accumulation point.
        
        “Inhalers Only” black non-RCRA hazardous waste may accumulate up to 180 days at a satellite accumulation point.
      - Health care and contracted staff shall notify the institution fire chief or hazmat coordinator whenever a black hazardous waste container approaches the maximum accumulation time or whenever it is 3/4 full.
      - Health care and contracted staff at each satellite accumulation point shall complete a hazardous waste container label, refer to the Sample Hazardous Waste Container Labels and Institution Environmental Protection Agency (EPA) Identification (ID) List, and attach it to the black hazardous waste container when the container accumulation begins. Each label shall include a proper shipping name (PSN) and description as follows:
        
        Solids (pills, topical creams/ointments, applicators)
        
        PSN of UN3249, waste medicine, solid, toxic, n.o.s. (warfarin/selenium sulfide), 6.1, II, P001, D010, U205, state 311
        
        Liquids (topical lotions, orals, injectables)
        
        PSN of UN1851, waste medicine, liquid, toxic, n.o.s. (selenium/chlorambucil), 6.1, II, D010, U035, state 311
        
        “Inhalers Only”
        
        PSN of UN1950, aerosols, (non-flammable-each not exceeding 1 LTR capacity), 2.2, state 311
        
        Specifically identified hazardous substances:
        
        Silver nitrate applicators
        
        PSN of UN1479, waste oxidizing solid, n.o.s. (silver nitrate), 5.1, II, D001, D011, state 311, or
        
        PSN of UN1493, waste silver nitrate, 5.1, II, D001, D011, state 311
        
        Ethyl chloride which is shipped as an aerosol but is actually in liquid form
        
        PSN of UN1037, waste ethyl chloride, 2.1, D001, state code 311
  - Disposal of Waste Containers with Mixed Classifications of Waste
    - When biohazardous waste, sharps waste, nonhazardous pharmaceutical waste, trace chemotherapy waste, non-RCRA hazardous waste, or RCRA hazardous waste are mixed in any combination of two or more different types of waste within the same waste container, the container shall be handled as specified below:
      - Any waste container that contains RCRA and non-RCRA hazardous waste shall be disposed of in a black hazardous waste container. Note: Mixed waste is medical waste, except when medical waste is mixed with hazardous waste, in which case it is considered hazardous waste and is subject to regulation as specified in the statutes and regulations applicable to hazardous waste. The waste shall be handled as follows:
        
        If the mixed waste container is not black, place the entire container into a black container, seal it, and properly label it.
        
        A Hazardous Waste Container Contents Log shall be completed indicating all the various types of waste included in the hazardous waste container. The hazardous waste shall be specifically identified so that the Uniform Hazardous Waste Manifest can be accurately completed. Failure to do so may result in violations reported to the federal agency by the hazardous waste transporter or treatment facility.
        
        Contact the institution fire chief or hazmat coordinator for removal of the black container.
      - When biohazardous waste is present in a yellow trace chemotherapy container or a blue nonhazardous pharmaceutical waste container, the container shall be labeled “Biohazardous Waste” or labeled with the international biohazard symbol with the word “BIOHAZARD” on the lid and sides. Once properly labeled, seal the container and take the container to the medical waste accumulation area.
      - When chemotherapy syringes or needles are present in a red sharps container, the container shall be labeled “chemotherapy waste” or (“chemo”) on the lid and sides. Once properly labeled, the container shall continue to be used until it approaches the maximum accumulation time or whenever it is 3/4 full, whichever comes first.
      - When nonhazardous pharmaceutical waste is present in a red biohazardous waste or yellow trace chemotherapy container, the container shall be placed in a properly labeled blue pharmaceutical waste container.
        
        The blue pharmaceutical waste container shall be labeled as follows:
        
        If the resulting container is mixed biohazardous and pharmaceutical waste, label the container as biohazard in addition to the nonhazardous pharmaceutical waste labeling.
        
        If the resulting container is mixed trace chemotherapy waste, and nonhazardous pharmaceutical waste, label it as biohazard and chemotherapy in addition to the proper nonhazardous pharmaceutical waste labeling.
        
        Seal the container and take the blue pharmaceutical waste container to the medical waste accumulation area.
      - When biohazardous and sharps waste are the only two wastes mixed together, the combination shall be placed in a sharps waste container and disposed of as follows:
        
        If the mixed waste container is not a sharps container, place the entire container into a sharps container.
        
        Seal the container and take the container to the medical waste accumulation area.
  - Unknown waste
    - Identification of the type of waste is required for proper destruction.
    - Staff that encounter unidentifiable waste outside of a proper waste container shall notify the institution fire chief or hazmat coordinator for assistance with proper destruction.
- Medical Waste Accumulation Areas
  - Each institution shall manage and store its own medical waste. Multiple institutions shall not share a medical waste accumulation area.
  - Institutions shall adhere to holding times for medical waste as outlined in Section (d)(3)(A)6.d.
  - Medical waste has a separate accumulation area from hazardous waste. Hazardous waste containers for RCRA pharmaceuticals, “Inhalers Only” hazardous waste containers, and dental hazardous waste shall be transported to the institution hazardous waste storage area by the institution fire chief or hazmat coordinator. Note: This section does not refer to the satellite accumulation points.
  - Interim accumulation areas (e.g., soiled utility rooms/dirty room) where medical waste is stored prior to transfer to the medical waste accumulation area shall be an area that is either locked or under direct supervision or surveillance. Interim accumulation areas shall be marked with the international biohazard symbol. The warning signs shall be readily legible from a distance of at least five feet. (This section does not apply to the rooms in which medical waste is generated.)
  - Medical waste shall be moved from the interim accumulation areas to the medical waste accumulation area (e.g., the medical waste storage area where the medical waste handler retrieves the waste) at mandated intervals. All interim and medical waste accumulation areas shall be marked with prominent signs on and adjacent to the exterior doors, stating “CAUTION-BIOHAZARDOUS WASTE STORAGE AREA-UNAUTHORIZED PERSONS KEEP OUT”, and in Spanish, “CUIDADO-ZONA DE RESIDUOUS-BIOLOGICOS PELIGROSOS – PROHIBIDA LA ENTRADA A PERSONAS NO AUTORIZADAS.”
  - Medical waste shall be stored in areas that are insect and rodent-free, dry, properly ventilated to the outdoors, and only accessible to authorized personnel. All medical waste shall be properly stored in a container in accordance with its medical waste stream. Biohazard bags shall not be stored on the floor at any time.
- Medical Waste Spill Clean Up
  - When a spill occurs, staff responsible for the spill shall immediately clean up the spill.
  - To clean up a medical waste spill, staff shall follow the outlined process based on the contents of the spill.
    - Biohazardous spills
      - Limit access to the area containing the spill to prevent exposure while clean up is in progress.
      - Gather the following equipment prior to beginning clean up:
        
        Adequate PPE shall be considered adequate only if it does not permit blood or other potentially infectious materials to pass through to or reach the employee’s work clothes, skin, eyes, mouth, or other mucous membranes under normal conditions of use and for the duration of time which the protective equipment will be used. PPE shall be provided at no cost to the employee. Appropriate PPE includes, but is not limited to, gloves, gowns, laboratory coats, face shields or masks, and eye protection.
        
        MWMA approved and state-supplied chemical sanitizing cleanser.
        
        A biohazard bag.
        
        A sharps container, if sharps are present.
        
        Equipment to assist in clean up such as absorbent material, tongs or forceps, brush, and dustpan.
      - If sharps are present, carefully pick them up using forceps or an appropriate tool (never use your hands) and place in a sharps container.
      - Cover the spill area with the absorbent material, sanitize the area using state- supplied chemical sanitizing cleanser, and allow solution to soak.
      - Work from the outside edges of spill inward when applying solution.
      - Use a brush and dustpan to scoop up the absorbent material, if necessary.
      - Spray chemical sanitizing cleanser in sufficient quantity to cover the area.
        
        Leave product for designated time based on product instructions to sanitize the area.
        
        Wipe up the sanitizing cleanser.
        
        Place all absorbent material into the biohazard bag and tie.
      - Transport the biohazard bag to the interim accumulation area and place the tied bag into a biohazardous waste container that is already lined with a biohazard bag.
      - Close the container and transport it to the medical waste accumulation area for pick up by the medical waste transporter at predefined intervals.
      - Ensure PPE and supplies are available for future use.
    - Sharps
      - Any glass, needles, or other sharps objects that may puncture the skin shall not be picked up by hand.
      - Use tongs or forceps to pick up the sharps waste and dispose of it into a sharps container. A brush and dustpan may be necessary to sweep up glass splinters from the floor. All pieces of glass or floor sweepings shall be placed into the sharps container.
      - The sharps container shall be transported to the medical waste accumulation area for pick up by the medical waste transporter at predefined intervals.
    - Nonhazardous pharmaceuticals
      - Wear rubber gloves.
      - Obtain a blue pharmaceutical waste container. Ensure the sides and top have appropriate labeling. For new, unused containers, mark the label with the accumulation start date.
      - When a spill includes a liquid medication, obtain state-supplied absorbent materials e.g., paper towels, chemical absorbent, or pharmaceutical pillows.
      - Clean up of nonhazardous pharmaceutical solids:
        
        If the spilled solid is known to be a DEA controlled substance, document the destruction pursuant to the HCDOM, Section 3.5.9, DEA Schedule II-V Controlled Substances, crush the dosage form, and place in the blue pharmaceutical waste container.
        
        Non-DEA controlled substances or unknown substances shall be picked up and placed in the blue pharmaceutical waste container.
      - Clean up of nonhazardous pharmaceutical liquids:
        
        Staff shall limit access to the area containing the spill while clean up is in progress.
        
        If the spilled liquid is known to be a DEA controlled substance, document the destruction pursuant to the HCDOM, Section 3.5.9, DEA Schedule II-V Controlled Substances.
        
        Spread state-supplied absorbent material, e.g., paper towels, chemical absorbent, or pharmaceutical pillows over the liquid spill. Provide adequate time for the material to absorb the spill. Pick up or sweep up absorbent material and place in a pharmaceutical waste container.
        
        Clean up remaining residue using appropriate state-supplied sanitizing cleanser.
      - Gloves worn may be disposed of in regular trash.
      - Use of the pharmaceutical waste container shall continue until 3/4 full or one year from the accumulation start date.
      - Staff shall ensure that there is an adequate stock of supplies for additional clean up endeavors.
    - Trace chemotherapy
      - Staff shall limit access to the area containing the spill to prevent exposure while clean up is in progress.
      - Wear appropriate PPE, such as two pairs of chemotherapy or medical gloves.
      - Obtain a yellow trace chemotherapy waste container or black waste container as indicated in the institution’s LOP.
      - Pick up the trace chemotherapy materials from the surface and place in a yellow trace chemotherapy waste container or black waste container as indicated in the institution’s LOP.
      - Clean contaminated surfaces with appropriate state-supplied cleanser and paper towels, chemical absorbent, or pharmaceutical pillows.
      - Place all spill clean-up material into the trace chemotherapy waste container or black waste container as indicated in the institution’s LOP.
      - Staff shall ensure that there is an adequate stock of supplies for additional clean up endeavors.
    - RCRA hazardous waste clean up
      - Limit access to the area containing the spill to prevent exposure while clean up is in progress.
      - Appropriate PPE shall be available. The required PPE depends upon the characteristics of the hazard. Characteristics include solid form, liquid form, aerosol form (ethyl chloride), powder form, or quantity of hazardous spill.
      - Obtain a RCRA black waste container and a Hazardous Waste Container Contents Log.
      - Clean up of solid RCRA hazardous waste:
        
        Wear two pairs of chemotherapy or medical gloves.
        
        Pick up solid dosage form from surface.
        
        Place solid dosage unit into the RCRA hazardous waste container.
        
        Place gloves worn into the RCRA black hazardous waste container.
        
        Complete the Hazardous Waste Container Contents Log.
      - The RCRA hazardous waste container shall be taken to the appropriate satellite accumulation point.
      - Staff shall ensure that supplies used are in adequate supply for additional clean up endeavors.
      - Clean up of liquid, aerosol (ethyl chloride), or powder RCRA hazardous waste shall occur with the cooperation of the institution fire chief or hazmat coordinator. Clean-up procedures will vary based upon the circumstances at the time such as, but not limited to, product spilled, quantity of spill, ventilation available, clean-up materials available, and training of staff.
- Medical Waste Tracking Document
  - The institution shall maintain medical waste tracking documents for all non-RCRA hazardous waste, which tracks the waste from the time it leaves the generator’s institution until it receives final treatment.
    - The medical waste transporter shall provide the institution with a copy of the tracking document at the time of pick up.
    - A final copy of the tracking document for treated medical waste shall be obtained by the institution and be reviewed for accuracy against the recorded quantity transported from the generator to the treatment site.
    - The final copy of the tracking document shall be maintained for a minimum of three years.
  - The tracking document shall include:
    - Name, address, telephone number, and registration number of the transporter.
    - The type of medical waste and the quantity or aggregate weight of the medical waste transported.
    - Name, address, and telephone number of the institution.
    - Name, address, telephone number, permit number, and the signature of an authorized representative of the permitted treatment facility receiving the medical waste.
    - Date that the medical waste is removed from the institution, the date that the medical waste is received by a transfer station, the registered large quantity generator, or point of consolidation, if applicable, and the date that the medical waste is received by the permitted treatment facility.
- Hazardous Waste Container Contents Log
  - Each RCRA and non-RCRA hazardous waste container (with the exception of “inhaler only” containers) shall have its own Hazardous Waste Container Contents Log. The institution fire chief or hazmat coordinator shall utilize the Hazardous Waste Container Contents Log to complete a hazardous waste manifest and to ensure that container labels are accurately completed. Health care and contracted staff shall complete a line entry onto the Hazardous Waste Container Contents Log each time RCRA and non- RCRA waste is placed into the container.
- Hazardous Waste Manifest
  - The institution shall maintain hazardous waste manifests that track hazardous waste from the time the waste leaves the generator’s institution until it receives final treatment also known as “Cradle to Grave Tracking.” The form required by the EPA is called the “Uniform Hazardous Waste Manifest.”
  - In order to complete a “Uniform Hazardous Waste Manifest” the institution fire chief or hazmat coordinator requires the contents of the black hazardous waste container. Each empty black hazardous waste container, with the exception of the containers labeled “Inhalers Only,” shall be issued a Hazardous Waste Container Content Log. Health care and contracted staff shall complete the Hazardous Waste Container Content Log each time waste is added to the black hazardous waste container.
  - The institution fire chief or hazmat coordinator shall complete the “Uniform Hazardous Waste Manifest” including:
    - The generator’s Federal EPA ID Number.
    - Total number pages used to complete the manifest.
    - Emergency response phone number in the event of an incident during transportation.
    - Manifest tracking number.
    - Generator’s mailing address, phone number, and site address.
    - Hazardous waste transporter’s name and EPA ID number.
    - Hazardous waste treatment facility name, site address, and EPA ID number.
    - US DOT description including proper shipping name, hazard class, EPA ID number and packing group.
    - Number of containers for each waste and the appropriate abbreviation for the type of container.
    - Units of measure.
    - Waste codes.
    - Special handling instructions and additional information.
    - Generators’ certifications.
  - The contracted hazardous waste transporter shall provide the institution with a shipping copy of the “Uniform Hazardous Waste Manifest” at the time of pick up. A final copy of the “Uniform Hazardous Waste Manifest” shall be issued by the RCRA hazardous waste treatment facility once the waste has been received. A copy of the final “Uniform Hazardous Waste Manifest” shall be obtained from the institution fire chief or hazmat coordinator and kept on file for a minimum of three years.
- Legal Requirements
  - Compliance requirements vary based upon the volume of waste that institutions generate. Each institution shall have a California Medical Waste Registration and an EPA ID Number. The requirements for each registration is distinct from the other. Therefore, an institution can be a large or a small quantity generator for medical waste and a large or small quantity generator for RCRA hazardous waste.
  - California Medical Waste Management
    - Registration and Inspection
      - Pursuant to the MWMA, the CEO or designee shall register and file an MWMP with their location’s LEA. Registration location and forms are determined by the agency that supervises the registration which may be CDPH or the local county. Refer to this link for more information.
        https://www.cdph.ca.gov/Programs/CEH/DRSEM/Pages/EMB/MedicalWaste/Local-Enforcement-Agencies.aspx.
      - Frequency of registration renewal and inspection is determined by the category of the medical waste generator.
        
        Large quantity generator registration is valid for one year with inspections at least annually.
        
        Small quantity generator, without onsite treatment, registration is valid for one year with inspections at least annually.
      - An application for renewal of the registration shall be filed with the LEA on or before the expiration date or each time the MWMP is modified.
    - Medical Waste Management Plan
      - Institutions shall develop an MWMP LOP consistent with MWMA and RCRA, utilizing the Medical Waste Management Plan Local Operating Procedure template. The MWMP LOP along with the HCDOM, Section 3.2.1, Disposal of Regulated Waste Generated by Health Care Staff shall be submitted to the LEA as the complete MWMP.
      - The development and maintenance of the LOP shall be assigned to an institution’s committee that includes, but is not limited to:
        
        CEO, or designee
        
        Chief Support Executive, or designee
        
        Chief Medical Executive, or designee
        
        Chief Nurse Executive, or designee
        
        Supervising Dentist, or designee
        
        Pharmacist-in-Charge, or designee
        
        Public Health Nurse or Infection Control Nurse, or designee
        
        Institution Fire Chief, Hazmat Coordinator, or designee
        
        Institution Warden, or designee
        
        Associate Warden, Health Care, or designee
      - The MWMP shall be certified by the CEO upon establishment and whenever the plan changes.
      - Institutions that generate medical waste shall submit an updated medical waste generator application form when any of the information specified in their MWMP changes. The updated application form shall be submitted to the LEA within 30 calendar days of the change. The medical waste generator application form is available at the following link:
        https://www.cdph.ca.gov/CDPH%20Document%20Library/ControlledForms/cdph8550.pdf
      - The institution shall establish a process and a frequency for adherence reviews to check for proper waste disposal within all health care service areas and shall maintain records of the reviews for a minimum of two years. Deficiencies identified shall be addressed by institutional health care leadership in a timely manner.
  - RCRA Hazardous Waste
    - RCRA hazardous waste is governed by the Federal EPA and the California Department of Toxic Substances Control. Institution compliance with the requirements is the responsibility of the institution fire chief or hazmat coordinator.
    - Health care and contracted staff is responsible for proper hazardous waste container use, satellite collection point management, waste storage, availability of supplies, completion of the Hazardous Waste Container Contents Log, black hazardous waste container labeling, and coordination with the institution fire chief or hazmat coordinator for hazardous waste container pick up.
- Handling Infractions or Irregularities
  - When an irregularity or infraction has been identified, the CEO or designee, with the assistance of the institutional health care leadership shall map the process that the medical waste went through from the point of generation to storage and shipment. An assessment shall be completed to determine when and where the irregularity or infraction occurred.
  - A written plan of correction shall be developed by the CEO or designee, with the assistance of the institutional health care leadership. The plan shall address how and why the violation occurred, how to mitigate the impact of the violation, who shall be notified of the violation, and if necessary, alternative storage facilitates shall be identified.
- Health Care and Contracted Staff Training
  - All health care and contracted staff who generate and dispose of regulated waste shall receive training in regulated waste management procedures upon hire and annually thereafter.
  - Training records shall be maintained for a period of a minimum of two years.
- Emergency Action Plan
  - Institutions shall design an emergency action plan to be taken in the event of a disruption of service, a natural disaster, or an equipment failure. The LOP shall include the process for delays in medical waste pick up including notification of the California Department of Public Health Medical Waste Management Program or the LEA for a holding time extension for medical waste to be stored onsite. The CDPH can be contacted at Headquarters (916) 449-5671 or Southern CA Regional Office at (818) 551-2042, (818) 551-2040, or (818) 551-2041.
    https://www.cdph.ca.gov/Programs/CEH/DRSEM/Pages/EMB/MedicalWaste/Contact-MWMP.aspx.
    Inquiries to the CDPH may be sent via email to MedWasteInfo@cdph.ca.gov. The list of the LEAs can be found at the following link:
    https://www.cdph.ca.gov/Programs/CEH/DRSEM/Pages/EMB/MedicalWaste/Local-Enforcement-Agencies.aspx.
References
Code of Federal Regulations, Title 29, Part 1910, Standard 1910-1910.1030, Occupational Safety & Health Standards
Code of Federal Regulations, Title 40, Parts 239-282, Environmental Protection Agency, Subpart 260-273, Hazardous Waste Management System, Resource Conservation and Recovery Act of 1976
United States Department of Transportation-Federal Motor Carrier Safety Administration, Hazardous Materials/Dangerous Goods Regulations:
https://www.fmcsa.dot.gov/regulations/hazardous-materials/hazardous-materialsdangerous-goods-regulations
California Health and Safety Code, Division 104, Part 14, Chapters 1-11, Sections 117600-118360 (Medical Waste Management Act), https://www.cdph.ca.gov/Programs/CEH/DRSEM/CDPH%20Document%20Library/EMB/MedicalWaste/MedicalWasteManagementAct.pdf
California Code of Regulations, Title 8, Division 1, Chapter 4, Subchapter 7, Group 16, Article 109, Section 5193
California Department of Toxic Substances Control www.dtsc.ca.gov
California Department of Public Health, Approved Medical Waste Transporters
https://www.cdph.ca.gov/Programs/CEH/DRSEM/Pages/EMB/MedicalWaste/Transporters.aspx
Health Care Department Operations Manual, Chapter 3, Article 5, Section 3.5.9, DEA Schedule II-V Controlled Substances
Health Care Department Operations Manual, Chapter 3, Article 5, Section 3.5.16, Medication Inventory Management, Labeling, and Storage
Health Care Department Operations Manual, Chapter 3, Article 5, Section 3.5.17, Handling of Hazardous Drugs
Health Care Department Operations Manual, Chapter 3, Article 5, Section 3.5.26, Break-in, Theft/Loss from Pharmacy or Medication Storage Areas
OSHA Review, https://oshareview.com/2013/07/sharps-waste-maximum-storage-times/
Regulated Medical Waste Resource Locator-OSHA Standards for Bloodborne Pathogens
http://www.hercenter.org/rmw/osha-bps.php
Do’s and Don’ts Safe Disposal Of Needles And Other Sharps Used at Home, At Work, Or Travel
https://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/Sharps/UCM278775.pdf
Journal of the Pharmacy Society of Wisconsin, November-December 2002, Charlotte A. Smith, RPh, MS,
https://www.gecap.info/pdf/managing_pharmaceutical_waste.pdf
PharmE^® Waste Wizard^® https://www.pharmecology.com/Landing
Revision History
Effective: 05/2019