Medical Waste Handling Requirements
Sonoma County Department of Health Services, Environmental Health Division,
is charged with administering the State of California’s Medical
Waste Program within Sonoma County. It is the responsibility of all generators
of regulated medical waste to comply with the Medical Waste Program.
Environmental Health provides support to generators through various
administrative activities, including but not limited to the following:
- Guidance and assistance in complying with the Medical Waste Program.
- Reviewing and processing medical waste management plans from all
generators.
- Issuing medical waste permits and registrations.
- Conducting evaluations and inspections.
- Responding to complaints and emergency incidents.
- Taking enforcement action when necessary.
An annual fee is required of all generators of medical waste to support
implementation of this program (see Medical
Waste Fee Schedule  ).
The Medical Waste Program was established by the California Department
of Health Services to ensure statewide standards for uniformity in the
safe handling, minimization and disposal of medical waste.
The regulations governing this program are found within the Medical
Waste Management Act of the California Health and Safety Code, Division
101, part 14, Chapters 1-11. A copy of this legislation may be obtained
by contacting:
California Department of Public Health
Medical Waste Management Program
P.O. Box 997377, MS 7405
Sacramento, CA 95899-7377
Phone: (916) 449-5671
Website: www.cdph.ca.gov/certlic/medicalwaste/Pages/default.aspx
What is regulated medical
waste?
Regulated medical waste is waste that meets both of the following requirements:
- The waste is either biohazardous or sharps waste.
- Biohazardous waste includes items such as fluid blood or fluid
blood products, infectious secretions, laboratory waste, microbiology
specimens, surgery specimens, animal parts or animal fluids contaminated
with infectious agents known to be contagious to humans.
- Sharps waste includes items such as hypodermic needles, syringes,
blades and needles with attached tubing, broken glass items, syringes
contaminated with biohazardous waste, acupuncture needles, root canal
files, or any other device capable of cutting or piercing.
- The waste is produced as a result of one or more of the following
actions:
- The diagnosis, treatment, or immunization of human beings or animals.
- Research pertaining to the activities specified above.
- The production and testing of biological agents.
- Accumulated home-generated sharps waste at an approved point of
consolidation.
- Removal of regulated waste from a trauma scene by a trauma scene
waste management practitioner.
Who generates medical waste?
A medical waste generator is typically a person or business involved
in the following activities:
- The diagnosis, treatment, or immunization of human beings or animals.
- Research pertaining to the activities specified above.
- The production and testing of biological agents.
The following are examples of businesses considered to be generators
of medical waste:
- Medical and dental offices
- Clinics
- Hospitals
- Surgery centers
- Laboratories/research laboratories
- Unlicensed and licensed health facilities
- Chronic dialysis clinics
- Education and research facilities
- Veterinary offices
- Clinics and hospitals
- Pet shops
- Trauma scene waste management practitioners.
What are generators required
to do?
-
Submit a Medical Waste Management Plan
provided by this Division. It must be renewed when any information
changes.
-
Submit the applicable registration and/or
permit fees on an annual basis to this Department.
-
Obtain medical waste permits and/or registration
from this Division.
-
Participate in annual inspections by this
Division when necessary.
-
Maintain tracking documents and other
required records if medical waste is treated on-site.
-
Comply with the Medical Waste Management
Act.
Which permit or
registration is required?
-
A Small Quantity Generator registration
is required for businesses that generate less than 200 pounds of
medical waste per month.
-
A Large Quantity Generator permit is required
for businesses that generate more than 200 pounds of medical waste
per month in any month of a 12-month period.
-
A Treatment permit is required for businesses
that treat (sterilize) medical waste on-site.
-
A Common Storage permit is required when
a business designates an accumulation site for medical waste used
by small quantity generators otherwise operated independently and
for the storage of such waste for collection by a registered hazardous
waste hauler.
-
A Limited Quantity Hauling Exemption permit
is required for any small quantity generator who wishes to transport
his/her own medical waste to a permitted transfer station or common
storage facility. The generator must generate no more than 20 pounds
of waste per week and may not transport more than 20 pounds of waste
at any one time.
-
A Home-Generated Sharps Consolidation
Point permit is required for those facilities that wish to accept
and consolidate home-generated sharps waste.
How is medical waste to
be stored?
Medical waste shall be contained separately from other waste at the
point of origin.
All biohazardous waste must be placed in a red bag labeled with the
words "Biohazardous Waste" or with the international biohazard
symbol and the word "BIOHAZARD." This red bag must be placed
in a rigid and leak-resistant container with a tight-fitting lid for
storage, handling or transport. This secondary container must be labeled
with the words "Biohazardous Waste" or with the international
biohazard symbol and the word "BIOHAZARD" on the lid and on
the sides in order to be visible from any lateral direction.
All sharps waste must be placed into a sharps container that is rigid,
puncture-resistant, leak- resistant when sealed, and difficult to reopen
once sealed. The sharps contained must be labeled with the words "SHARPS
WASTE" or with the international biohazard symbol and the word "BIOHAZARD." Sharps
containers may be placed in red biohazard bags or in rigid containers
with biohazard bags.
Waste such as gloves, disposable gowns, towels, intravenous solution
bags and attached tubing which are empty and considered biohazardous
waste through contact with, or having previously contained chemotherapeutic
agents, must be placed in a secondary container labeled with the words "CHEMOTHERAPY
WASTE" or "CHEMO."
Biohazardous waste, which is recognizable human anatomical parts or
comprised of human surgery specimens or tissues which have been fixed
in formaldehyde or other fixatives, must be placed in a secondary container
labeled with the words "PATHOLOGY WASTE" or "PATH."
Pharmaceutical waste that is either prescription, over-the-counter,
or a veterinary drug may be considered biohazardous waste by definition
and must be placed in a container labeled with the words "INCINERATION
ONLY." This does not include pharmaceuticals that are listed or
defined as hazardous under RCRA or the Radiation Control Law. These pharmaceuticals
are regulated under the federal Resource Conservation and Recovery Act
of 1976 or the Radiation Control Law (Chapter 8, Part 9). In addition,
pharmaceuticals that were not previously hazardous under the California
Hazardous Waste Control Law will continue to be regulated as solid waste
and may therefore be disposed of in the garbage. In summary, pharmaceutical
waste fall into one of three categories based upon their toxicity: hazardous
waste, medical waste, or solid waste.
Any area designated for the accumulation and storage of medical waste
containers must be secured to prevent entry by unauthorized persons.
The exterior door, gate, or lid must be marked with a warning sign in
both English and Spanish and any other appropriate languages. The wording
shall read "Caution-Biohazardous Waste Storage Area—Unauthorized
Persons Keep Out," and in Spanish "Cuidado-Zona De Residous-Biologicos
Peligrosos-Prohibida La Entrada A Personas No Autorizadas."
How long may medical
waste be stored?
Biohazardous waste may not be stored for more than seven days unless
the business generates less than 20 pounds per month. In this case, the
waste may be stored up to 30 days. However, if the biohazardous waste
is stored at or below 0 degrees centigrade (32 degrees Fahrenheit), it
may be stored up to 90 days with approval from this Division.
Full sharps containers ready for disposal may not be stored for more
than 30 days.
Pharmaceutical waste containers that are full and ready for disposal may not be stored longer than 90 days. Whether full or not, the container may not remain on site for more than a year.
How do I dispose of medical
waste?
The majority of waste is transported to an off-site medical waste treatment
facility by a registered hazardous waste hauler or via the postal service
using a mail-back system where it is sterilized prior to disposal in
a landfill. Some generators transport their own waste to a common storage
facility while others may choose to treat their waste on-site prior to
disposal.
If untreated medical waste is picked up at the generator’s business
by a registered hazardous waste hauler, insure that, at the time of pickup,
the hauler provides a copy of the tracking document. Small quantity generators
are required to keep tracking documents for two years and large quantity
generators for three years.
Only businesses that generate less than 20 pounds of medical waste per
week may opt to transport their own waste. A Limited Quantity Hauling
Exemption Permit must be approved and obtained by this Division prior
to transporting any waste. No more than 20 pounds of medical waste may
be transported at any one time. Only the generator or member of his/her
staff may transport the waste. A tracking document must be in the driver’s
possession while transporting waste and the original tracking document
must be provided to the receiving facility (permitted medical waste treatment
facility, consolidation point, transfer station, parent organization).
Sharps waste may not be disposed anywhere in Sonoma County whether it
has been treated or not. Therefore, all sharps waste must be transported
out of Sonoma County for treatment and disposal.
Those generators wishing to treat their own medical waste on-site must
be approved for and obtain a treatment permit from this Division. Treatment
must be done using an approved method, the most common of which is steam
sterilization. Those using steam sterilization must establish written
operating procedures, check the thermometer during each cycle to verify
an attainment of 121degrees centigrade (250 degrees Fahrenheit) for at
least 30 minutes, test the thermometer for calibration annually, use
indicator heat-sensitive tape on each biohazard bag and sharps container,
and conduct monthly biological indicator tests on the autoclave. Records
of these procedures noted above must be kept for three years. Once medical
waste is treated, it ceases to be regulated under the Medical Waste Management
Act and is considered solid waste.
Where can I get more information?
Please feel free to contact this Division at (707) 565-6565 to request
more information or if you have any questions regarding the Medical Waste
Management Act and how it might apply to your business. This guide to Medical
Waste Handling Requirements may also be downloaded in Adobe Acrobat
format.
The California Department of Public Health Services can provide you with another
helpful tool called the "Self-Assessment Manual for Proper Management
of Medical Waste." This manual is designed to assist health care
facilities in complying with requirements of the Medical Waste Management
Act by providing instruction in the use of a self-assessment tool to
help ensure that medical wastes are properly handled, safely stored and
adequately treated on-site or sent for off-site treatment at an approved
facility. This manual also provides information about waste minimization,
sound waste handling practices and continuous quality improvement. Their
contact information was previously provided.
The California Department of Public Health Services has another helpful tool
called, "A Guide to Mercury Assessment and Elimination in Healthcare
Facilities."
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