The Oregon Administrative Rules contain OARs filed through November 15, 2015

 

QUESTIONS ABOUT THE CONTENT OR MEANING OF THIS AGENCY'S RULES?
CLICK HERE TO ACCESS RULES COORDINATOR CONTACT INFORMATION

 

OREGON HEALTH AUTHORITY,

PUBLIC HEALTH DIVISION

 

DIVISION 56
INFECTIOUS WASTE MANAGEMENT
333-056-0010

Purpose of Infectious Waste Administrative Rules
The purpose of OAR 333-056-0020 through 333-056-0050 is to define terms related to infectious waste and to prescribe acceptable methods of storage and treatment of infectious waste.
Stat. Auth.: ORS 431.110, 433.004 & 459.395

Stats. Implemented: ORS 459.395

Hist.: HD 15-1990, f. 6-5-90, cert. ef. 7-1-90; OHD 15-2001, f. & cert. ef. 7-12-01, Renumbered from 333-018-0040
333-056-0020
Definitions Relating to Infectious Waste
As used in OAR 333-056-0010 through
333-056-0050, unless the context requires otherwise, the following definitions apply:
(1) "Act" means chapter 763,
Oregon Laws, 1989, codified as ORS 459.386 to 459.405.
(2) "Disposal" means the
final placement of treated infectious waste in a disposal site operating under a
permit issued by a state or federal agency.
(3) "Disposal site" means
land and facilities used for the disposal, handling or transfer of, or resource
recovery from solid wastes, including but not limited to dumps, landfills, sludge
lagoons, sludge treatment facilities, disposal sites for septic tank pumping or
cesspool cleaning service, transfer stations, resource recovery facilities, incinerators
for solid waste delivered by the public or by a solid waste collection service,
composting plants and land and facilities previously used for solid waste disposal
at a land disposal site. "Disposal site" does not include:
(a) A facility subject to
the permit requirements of ORS 468.740;
(b) A landfill site which
is used by the owner or person in control of the premises to dispose of soil, rock,
concrete or other similar non-decomposable materials, unless the site is used by
the public either directly or through a solid waste collection service; or
(c) A site operated by a
wrecker issued a certificate under ORS 822.110.
(4) "Division" means the
Oregon Health Authority, Public Health Division.
(5) "Incineration" means
the reduction in volume and weight of waste by combustion.
(6) "Infectious waste" means:
(a) "Biological waste", which
includes blood and blood products, excretions, exudates, secretions, suctionings
and other body fluids that cannot be directly discarded into the municipal sewer
system, and waste materials saturated with blood or body fluids, but does not include
diapers soiled with urine or feces. In addition, biological waste does not include
articles contaminated with fully absorbed or dried blood, such as gauze, paper towels,
and sanitary napkins;
(b) "Cultures and stocks",
which includes etiologic agents and associated biologicals, including specimen cultures
and dishes and devices used to transfer, inoculate and mix cultures, wastes from
production of biologicals, and serums and discarded live and attenuated vaccines.
"Cultures" does not include throat and urine cultures;
(c) "Pathological waste",
which includes biopsy materials and all human tissues, anatomical parts that emanate
from surgery, obstetrical procedures, autopsy and laboratory procedures and animal
carcasses exposed to pathogens in research and the bedding and other waste from
such animals. "Pathological waste" does not include teeth or formaldehyde or other
preservative agents;
(d) "Sharps", which includes
needles, IV tubing with needles attached, scalpel blades, lancets, glass tubes that
could be broken during handling and syringes that have been removed from their original
sterile containers;
(e) "Syringe" means an instrument
for the injection of medicine or the withdrawal of body fluids that consists of
a hollow barrel fitted with a plunger and a hollow needle.
(7) "Landfill" means a facility
for the disposal of solid waste involving the placement of solid waste on or beneath
the land surface.
(8) "Noninfectious" means
a state in which a disease causing agent is not capable of causing an infection
to occur.
(9) "Saturated Waste" means
waste that contains enough body fluid that it would cause dripping of the body fluid
from the waste container, with or without compaction.
(10) "Sterilization" means,
for purposes of these rules, any process which changes infectious waste so that
disease causing agents contained within it are rendered non-infectious at the time
the process is completed.
(11) "Storage" means the
temporary containment of infectious waste in a manner that does not constitute treatment
or disposal of such waste.
(12) "Transportation" means
the movement of infectious waste from the point of generation over a public highway
to any intermediate point, to the point of final treatment, and to the point of
final disposal.
(13) "Treatment" means incineration,
sterilization or other method, technique or process approved by the Oregon Health
Authority, Public Health Division that changes the character or composition of any
infectious waste so as to render the waste noninfectious. Treatment also includes
methods of rendering waste noninfectious, which are approved by the Environmental
Quality Commission.
Stat. Auth.: ORS 431.110, 433.004 &
459.395
Stats. Implemented: ORS 431.110,
433.004 & 459.395
Hist.: HD 15-1990, f. 6-5-90,
cert. ef. 7-1-90; OHD 15-2001, f. & cert. ef. 7-12-01, Renumbered from 333-018-0050;
PH 16-2013, f. 12-26-13, cert. ef. 1-1-14; PH 10-2015, f. 7-2-15, cert. ef. 7-3-15
333-056-0030
Infectious Waste Treatment
(1) Pathological wastes shall be treated
by incineration in an incinerator that provides complete combustion of waste to
carbonized or mineralized ash. However, if the Department of Environmental Quality
determines that incineration is not reasonably available within a wasteshed, pathological
wastes may be disposed of in the same manner provided for cultures and stocks.
(2) Cultures, stocks, sharps
and biological wastes must be treated using one of the following methods, as delineated
in subsections (2)(a), (b) and (c) of this rule:
(a) Treated via incineration.
If incineration is utilized, it shall be done in compliance with all applicable
rules established by the Environmental Quality Commission;
(b) Sterilization with saturated
steam in a pressurized vessel. If this method is employed, a vessel dedicated to
infectious waste treatment must be utilized. Operating procedures which must be
developed and implemented shall include at least the following:
(A) Adoption of standard
written operating procedures for each steam sterilizer including time, temperature,
pressure, type of waste, type of container(s), type of closure on container(s),
pattern of loading, and maximum load quantity. The manufacturer's recommendations
shall be taken into account;
(B) Methods for monitoring
recording or temperature measuring devices during each complete cycle to ensure
that the manufacturer's recommended temperature is attained for the recommended
amount of time in order to achieve sterilization of the entire load. Temperature
measuring devices shall be checked for calibration at least annually;
(C) Methods for using heat
sensitive tape or other device designed to indicate attainment of adequate sterilization
conditions, for each container;
(D) Methods for at least
monthly use of the biological indicator Bacillus stearothermophilus, or equivalent,
placed at the center of a load processed under standard operating conditions, to
confirm the attainment of adequate sterilization conditions;
(E) Methods for maintenance
of records pertaining to paragraphs (2)(a)(A), (B) and (D) of this rule. These records
shall be maintained and available for Division review for a period of not less than
one year.
(c) Treated by other methods
that meet the following criteria:
(A) The specific processes
of the method have been tested under the conditions in which the method would be
used in Oregon for the treatment of infectious waste. Such testing has demonstrated
that the method is effective in rendering infectious agents non-infectious by showing
bactericidal efficacy against at least spore-forming bacteria and a Mycobacterium.
The testing methodology, test results, and documentation thereof must be considered
scientifically valid by the Division. The determination of validity requires, but
is not limited to:
(i) The testing methodology
follows basic scientific principles or objectivity and is fully documented;
(ii) The results of the testing
are fully documented. Raw data are made available to the Division if they are requested
by the Division;
(iii) The testing has been
done by a scientist(s) with an advanced degree in microbiology and with a record
of having published scientific research results in a peer reviewed journal;
(iv) The report of the testing
methodology and results, together with the statement "This report is an accurate
and complete account of the test methods I performed and the test results I obtained"
have been signed by the scientist(s) who performed the testing; and
(B) Any discharges into air
or water and any solid waste resulting from the method meet the requirements of
the laws and administrative rules of the Oregon Department of Environmental Quality;
or
(C) The Environmental Quality
Commission has approved the method and has accepted that method by administrative
rule.
(3) Liquid or soluble semi-solid
biological wastes may be discharged into a sewage treatment system that provides
secondary treatment of waste.
(4) After treatment approved
by the Division or the Environmental Quality Commission, sharps may be disposed
of directly into a permitted land disposal site only if the sharps are in a red,
leak-proof, rigid, puncture-resistant container which is taped closed or tightly
lidded to prevent loss of the contents. The containers may not be compacted or otherwise
broken before placement in the landfill. They must be placed in a segregated area
of the landfill.
(5) Methods of treatment
which have not been delineated in this rule or approved by the Division or the Environmental
Quality Commission, as applicable, are not permitted.
Stat. Auth.: ORS 431.110, 433.004 &
459.395
Stats. Implemented: ORS 431.110,
433.004 & 459.395
Hist.: HD 15-1990, f. 6-5-90,
cert. ef. 7-1-90; HD 20-1991(Temp), f. & cert. ef. 11-8-91; HD 13-1992(Temp),
f. & cert. ef. 12-23-92 (and corrected 12-30-92); HD 29-1994, f. & cert.
ef. 12-2-94; OHD 15-2001, f. & cert. ef. 7-12-01, Renumbered from 333-018-0060;
PH 16-2013, f. 12-26-13, cert. ef. 1-1-14
333-056-0040
Infectious Waste Storage Times and
Temperature
(1) Infectious waste shall be segregated
from other wastes by separate containment at the point of generation.
(2) Enclosures used for storage
of infectious waste shall be secured to prevent access by unauthorized persons and
marked with prominent warning signs.
(3) Pathological waste, biological
waste and cultures/stocks shall be treated or disposed of pursuant to OAR 333-056-0010
through 333-056-0030 within seven days of generation, unless it is refrigerated
(between 33 and 48 degrees Fahrenheit) or frozen (less than 32 degrees Fahrenheit).
Refrigerated or frozen infectious waste may be stored 30 days prior to treatment
or disposal.
(4) Prior to being treated
pursuant to OAR 333-056-0010 through 333-056-0030, sharps contained in a leak proof,
rigid, puncture resistant container which is taped closed or tightly lidded to prevent
loss of the contents may be stored indefinitely.
(5) Generators that produce
50 pounds or less of infectious waste in any calendar month shall be exempt from
the requirements pertaining to storage times and temperatures.
Stat. Auth.: ORS 431.110, 433.004 &
459.395
Stats. Implemented: ORS 431.110,
433.004 & 459.395
Hist.: HD 15-1990, f. 6-5-90,
cert. ef. 7-1-90; OHD 15-2001, f. & cert. ef. 7-12-01, Renumbered from 333-018-0070;
PH 16-2013, f. 12-26-13, cert. ef. 1-1-14
333-056-0045
Exemption for Placenta Removal from
a Health Care Facility
(1) Notwithstanding any other provision
in these rules, a health care facility or freestanding birthing center, as those
terms are defined in ORS 442.015, may release a placenta to the woman from whom
the placenta originated, or to her designee, if:
(a) The facility or birthing
center has a written policy and procedure to ensure the safe management and transport
of placentas;
(b) The woman tested negative
for infection by hepatitis B and human immunodeficiency viruses by testing obtained
since the beginning of the pregnancy; and
(c) The woman, or her designee,
and the woman’s health care provider sign a form that contains at least the
following:
(A) The woman’s name,
date of birth, address and the name of the health care provider;
(B) An attestation by the
woman or her designee that the placenta will not be used for commercial purposes;
and
(C) An attestation by the
health care provider that:
(i) Since the beginning of
the pregnancy the woman tested negative for infection by hepatitis B and human immunodeficiency
viruses;
(ii) The woman either tested
negative for hepatitis C virus since the beginning of the pregnancy or is not at
risk for hepatitis C; and
(iii) To the health care
provider’s knowledge, the woman has no infection that poses a threat to persons
who handle the placenta.
(2) The health care facility
or freestanding birthing center must keep a copy of the signed release form described
in subsection (1)(c) of this rule in the mother’s medical record.
(3) Health care facilities
and freestanding birthing centers shall make policies and procedures developed in
accordance with subsection (1)(a) of this rule available to the Division upon request.
(4) Nothing in this rule
prohibits a health care facility or freestanding birthing center from having additional
requirements for the removal of a placenta from the facility or center.
Stat. Auth.: ORS 431.110, 433.004, 459.400
Stats. Implemented: ORS 431.110,
433.004, 459.400
Hist.: PH 16-2013,
f. 12-26-13, cert. ef. 1-1-14
333-056-0050
Prevention of Disease Transmission
by Blood-Contaminated Sharp Objects
Any person using sharp instruments (for
example, needles, lancets, scalpels) for purposes of drawing blood, administering
medication, or medical/surgical procedures on humans, shall dispose of such items
in a manner that will protect any other handlers of this waste from injury. The
disposal of such waste shall be in accordance with current recommendations of the
U.S. Centers for Disease Control and Prevention, and shall include the use of impervious,
rigid, puncture-proof containers. This rule applies to but is not limited to blood
banks, plasmapherisis centers, medical clinics, dental offices, outpatient care
centers, inpatient care facilities, hospitals, and home health agencies.
Stat. Auth.: ORS 431.110, 433.004 &
459.395
Stats. Implemented: ORS 431.110,
433.004 & 459.395
Hist.: HD 4-1987, f. 6-12-87,
ef. 6-19-87; OHD 15-2001, f. & cert. ef. 7-12-01, Renumbered from 333-019-0212;
PH 16-2013, f. 12-26-13, cert. ef. 1-1-14

The official copy of an Oregon Administrative Rule is
contained in the Administrative Order filed at the Archives Division,
800 Summer St. NE, Salem, Oregon 97310. Any discrepancies with the
published version are satisfied in favor of the Administrative Order.
The Oregon Administrative Rules and the Oregon Bulletin are
copyrighted by the Oregon Secretary of State. Terms
and Conditions of Use