December 13, 2007, Introduced by Rep. Miller and referred to the Committee on Regulatory Reform.
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending sections 13805, 13807, 13809, 13811, 13813, 13819,
13830, and 13831 (MCL 333.13805, 333.13807, 333.13809, 333.13811,
333.13813, 333.13819, 333.13830, and 333.13831), sections 13805,
13807, 13809, and 13811 as added by 1990 PA 21 and sections 13813,
13819, 13830, and 13831 as added by 1990 PA 18, and by adding
section 13816.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
Sec. 13805. (1) "Advisory council" means the interdepartmental
medical waste advisory council created in section 13827.
(2) "Autoclave" means to sterilize using superheated steam
under pressure.
(3) "Decontamination" means rendering medical waste safe for
routine handling as solid waste.
(4) "Fund" means the medical waste emergency response fund
created in section 13829.
(5) "Health facility or agency" means that term as defined in
section 20106.
(6) "Household" means a single detached dwelling unit or a
single unit of a multiple dwelling.
(7) "Infectious agent" means a pathogen that is sufficiently
virulent so that if a susceptible host is exposed to the pathogen
in an adequate concentration and through a portal of entry, the
result could be transmission of disease to a human.
(8) "Medical waste" means any of the following that are not
generated from a household, a farm operation or other agricultural
business, a home for the aged, or a home health care agency:
(a) Cultures and stocks of infectious agents and associated
biologicals, including laboratory waste, biological production
wastes, discarded live and attenuated vaccines, culture dishes, and
related devices.
(b) Liquid human and animal waste, including blood and blood
products and body fluids, but not including urine or materials
stained with blood or body fluids.
(c) Pathological waste.
(d) Sharps.
(e) Contaminated wastes from animals that have been exposed to
agents infectious to humans, these being primarily research
animals.
(f) Trauma scene waste.
Sec. 13807. (1) "Pathogen" means a microorganism that produces
disease.
(2) "Pathological waste" means human organs, tissues, body
parts other than teeth, products of conception, and fluids removed
by trauma or during surgery or autopsy or other medical procedure,
and not fixed in formaldehyde.
(3) "Point of generation" means the point at which medical
waste leaves the producing facility site.
(4) "Producing facility" means a facility that generates,
stores, decontaminates, or incinerates medical waste.
(5) "Release" means any spilling, leaking, pumping, pouring,
emitting, emptying, discharging, injecting, escaping, leaching,
dumping, or disposing of medical waste into the environment in
violation of this part.
(6) "Response activity" means an activity necessary to protect
the public health, safety, welfare, and the environment, and
includes, but is not limited to, evaluation, cleanup, removal,
containment, isolation, treatment, monitoring, maintenance,
replacement of water supplies, and temporary relocation of people.
(7) "Sharps" means needles, syringes, scalpels, and
intravenous tubing with needles attached.
(8) "Storage" means the containment of medical waste in a
manner that does not constitute disposal of the medical waste.
(9) "Transport" means the movement of medical waste from the
point of generation or from a trauma scene to any intermediate
point and finally to the point of treatment or disposal. Transport
does not include the movement of medical waste from a health
facility or agency to another health facility or agency for the
purposes of testing and research.
(10) "Trauma scene" means a location soiled by or contaminated
with pathological waste as a result of a serious human injury,
illness, or death. Trauma scene includes, but is not limited to, a
physical structure that is not fixed geographically, such as a
mobile home, trailer, or vehicle.
(11) "Trauma scene waste" means pathological waste that has
been removed, is to be removed, or is in the process of being
removed from a trauma scene by a trauma scene waste management
practitioner.
(12) "Trauma scene waste management practitioner" means a
person that is required to register with the department to receive
a trauma scene waste transport permit in order to engage in the
cleanup, handling, and transport of trauma scene waste from a
trauma scene in this state.
Sec.
13809. A Except as
otherwise provided under section
13816, a trauma scene waste management practitioner and a producing
facility that does not incinerate medical waste on site shall do
all of the following to contain medical waste:
(a) Package, contain, and locate medical waste in a manner
that protects and prevents the medical waste from release at the
producing facility or at any time before ultimate disposal.
(b) Separate the categories of medical waste at the point of
origin
into appropriate containers that are labelled labeled as
required under subdivision (c).
(c) Label the containers required under subdivision (b) with a
biohazard
symbol or the words "medical waste", or "pathological
waste", or "trauma scene waste" in letters not less than 1 inch
high.
(d) Not compact or mix medical waste with other waste
materials before decontamination, incineration, and disposal.
(e) If decontaminated medical waste is mixed with other solid
waste, clearly label the container to indicate that it contains
decontaminated medical waste.
(f) Store medical waste in such a manner that prevents
putrefaction and also prevents infectious agents from coming in
contact with the air or with individuals.
(g) If medical waste is stored outside of the producing
facility or at the business location of a trauma scene waste
management practitioner, store the medical waste in a secured area
or locked in a container that weighs more than 500 pounds and
prevent access to the area or container by vermin or unauthorized
individuals.
(h) Not store medical waste on the premises of the producing
facility for more than 90 days.
Sec. 13811. A trauma scene waste management practitioner and a
producing facility shall store, decontaminate, and dispose of
medical waste pursuant to the following:
(a) Cultures and stocks of material contaminated with an
infectious agent shall be stored in closed, puncture-resistant
containers, decontaminated by autoclaving or incineration, and
disposed of in a sanitary landfill.
(b) Blood and blood products and body fluids shall be disposed
of by 1 or more of the following methods:
(i) Flushing down a sanitary sewer.
(ii) Decontaminating by autoclaving or incineration.
(iii) Solidifying.
(iv) If not in liquid form, transferring to a sanitary
landfill.
(v) A process approved by the department.
(c) Pathological waste and trauma scene waste shall be
disposed of by 1 or more of the following methods:
(i) Incineration or cremation.
(ii) Grinding and flushing into a sanitary sewer.
(iii) Burial in a cemetery, if transported in leakproof
containers of sufficient integrity to prevent rupture.
(iv) Grinding until rendered unrecognizable, stored in closed,
puncture-resistant, properly labeled containers, and, if not in
liquid form, disposed of in a sanitary landfill.
(v) A process approved by the department.
(d) Sharps shall be disposed of by 1 of the following methods:
(i) Placement in rigid, puncture-resistant containers that are
appropriately labeled and transported to a sanitary landfill in a
manner that retains the integrity of the container.
(ii) Incineration or decontamination and grinding that renders
the objects unrecognizable. Ground sharps shall be placed in a
sealed, rupture-resistant container and transported to a sanitary
landfill.
(iii) A process approved by the department.
(e) Animal waste contaminated with organisms infectious to
humans shall be disposed of by incineration or by burial in a
sanitary landfill in properly labeled, double containers that are
leakproof and puncture-resistant and are tightly sealed to prevent
escape of fluids or material. Contaminated animal organs disposed
of separately shall be rendered unrecognizable.
Sec. 13813. (1) Each producing facility shall register with
the department on a form prescribed by the department. A producing
facility shall have a written medical waste management plan that
contains information required in section 13817 on file on the
premises within 90 days after registration.
(2) A producing facility shall submit the following
registration fee with the registration form:
(a) For a producing facility that is a private practice office
with fewer than 4 licensees under article 15 who are physicians,
dentists, podiatrists, certified nurse practitioners, certified
nurse midwives, or veterinarians employed by, under contract to, or
working at the producing facility, a registration fee of $50.00.
(b) For a producing facility that is a private practice office
with 4 or more licensees under article 15 who are physicians,
dentists, podiatrists, certified nurse practitioners, certified
nurse midwives, or veterinarians employed by, under contract to, or
working at the producing facility, a registration fee of $20.00 for
each licensee, up to a maximum total registration fee of $80.00.
(3) Upon receipt of a complete registration form and
registration fee under this section or section 13815, the
department shall issue a certificate of registration to the
producing facility. A certificate of registration issued under this
section is valid for 3 years from its date of issuance. The
department shall investigate each complaint received and may
inspect a producing facility registered under this section pursuant
to the receipt of a complaint.
(4)
Registration fees collected pursuant to this section, and
section 13815, and section 13816 shall be forwarded to the state
treasury and deposited pursuant to section 13829.
Sec. 13816. (1) On and after the effective date of this
section, a person shall not engage in the cleanup, handling, and
transport of trauma scene waste from a trauma scene in this state
unless the person is registered and has been issued a trauma scene
waste transport permit under this section. Except as otherwise
provided in this subsection, before a person engages in the
cleanup, handling, and transport of trauma scene waste from a
trauma scene in this state, the person shall apply for registration
and to receive a trauma scene waste transport permit on forms and
in the manner prescribed by the department. A person who was
engaging in the cleanup, handling, and transport of trauma scene
waste from a trauma scene in this state on the day before the
effective date of this section may continue to engage in the
cleanup, handling, and transport of trauma scene waste from a
trauma scene on and after the effective date of this section
subject to the following:
(a) Within 30 days of the effective date of this section, the
person shall notify the department that the person is engaging in
the cleanup, handling, and transport of trauma scene waste from a
trauma scene and that the person intends to continue to engage in
that activity.
(b) On or before the date and in the manner prescribed by the
department, the person shall submit an application for registration
and to receive a trauma scene waste transport permit.
(c) Upon receipt of the application under subdivision (b), the
department shall proceed in the manner prescribed in subsection (3)
for acting upon a new application and either issue a certificate of
registration and a trauma scene waste transport permit or notify
the person that its application for registration and issuance of a
trauma scene waste transport permit has been denied under this
section and include the reasons for the denial. The person shall
immediately cease operation as a trauma scene waste management
practitioner upon receipt of a notice that its application for
registration and issuance of a trauma scene waste transport permit
has been denied under this section. A person who receives a notice
that its application for registration and issuance of a trauma
scene waste transport permit has been denied under this subdivision
may reapply as prescribed in subsection (2), and the department
shall proceed in the manner prescribed in subsection (3) on the
application as if it were a new application.
(2) A person that submits an application for registration and
to receive a trauma scene waste transport permit under this section
shall submit all of the following with the application:
(a) A registration fee of $150.00.
(b) A written trauma scene waste management plan that meets
the requirements of subsection (6).
(c) Proof of financial responsibility for bodily injury,
property damage, or environmental damage to third parties caused by
accidental occurrences arising from the trauma scene waste cleanup
and transport activities of the trauma scene waste management
practitioner.
(d) Subject to subsection (4), a fee prescribed by the
department to cover the expense of the background check required
under subsection (3).
(3) Upon receipt of a complete application for registration
form under this section and subject to subsection (4), the
department shall cause to be conducted a background check of all
individuals listed in the application as being the owners,
officers, directors, partners, or other key employees of the trauma
scene waste management practitioner. The department shall determine
whether any information received as a result of the background
check makes the practitioner ineligible to be registered and issued
a trauma scene waste transport permit under this section and, if
so, shall not register or issue a permit to the person. The
department shall notify the person that its application for
registration and issuance of a trauma scene waste transport permit
has been denied under this section and include the reasons for the
denial. A person who receives a notice that the issuance of its
application for registration and issuance of a trauma scene waste
transport permit has been denied under this subsection may reapply
in the manner prescribed in subsection (2), and the department
shall proceed in the manner prescribed in this subsection on the
application as if it were a new application. If the department
determines that the applicant is able to engage in the cleanup,
handling, and transport of trauma scene waste in a manner that will
protect the public health, safety, welfare, and the environment,
the department shall issue a certification of registration and a
trauma scene waste transport permit to the practitioner under this
section. If any of the information or documentation required under
subsection (2) is not yet available at the time of application, the
department may issue a permit on a conditional basis, subject to
receipt of that information or documentation as soon as practical
after issuance of the conditional permit. The applicant shall
comply with all deadlines and requirements for the submission of
the information or documentation in order to receive an
unconditional trauma scene waste transport permit under this
section.
(4) A certificate of registration and trauma scene waste
transport permit issued under this section is valid for 1 year from
the date of issuance. A trauma scene waste management practitioner
shall comply with subsection (2) and any rules or other guidance
issued by the department to obtain a renewal permit under this
section. The department shall act on a renewal application in the
same manner as a new application under subsection (3). However, the
department is not required to conduct a background check annually,
but shall conduct a background check of a trauma scene waste
management practitioner for a renewal application at least once
every 3 years.
(5) Within 90 days of the effective date of this section and
on a continuing basis, the department, in consultation with the
trauma scene waste management industry and the health care
industry, shall establish the following standards:
(a) Documentation of personal protection required to be
provided for and used by employees of trauma scene waste management
practitioners.
(b) Technologies and chemicals appropriate to the task of
cleaning, handling, and disinfecting a trauma scene.
(c) Other standards as necessary.
(6) A trauma scene waste management practitioner shall develop
a trauma scene waste management plan that contains information
relating to the cleanup, handling, and transport of all trauma
scene waste removed, stored, transported, and disposed of by a
trauma scene waste management practitioner. The trauma scene waste
management practitioner shall describe in the plan the personal
protection required to be provided to its employees to minimize
exposure to infectious agents throughout the process of handling
and transporting trauma scene waste; the technologies, chemicals,
and procedures to be used in the task of cleaning, handling, and
disinfecting the trauma scene; and any other information that the
department determines is necessary under subsection (5). Upon
request, a trauma scene waste management practitioner shall produce
its current trauma scene waste management plan for an employee of
the department pursuant to a routine or unannounced inspection or
the investigation of a complaint. A trauma scene waste management
practitioner shall maintain a current version of its trauma scene
waste management plan on file on the premises at all times. Upon
revision of any portion of its trauma scene waste management plan,
the trauma scene waste management practitioner shall promptly file
the revised plan with the department and shall comply with all
requirements of the department under section 13819.
(7) A trauma scene waste management practitioner shall comply
with its trauma scene waste management plan and shall transport
trauma scene waste to a producing facility that decontaminates or
incinerates medical waste for treatment or disposal. A trauma scene
waste management practitioner shall not store trauma scene waste on
its premises for more than 14 days. A trauma scene waste management
practitioner shall package medical waste in the manner prescribed
in section 13821 and as otherwise prescribed by the department.
(8) The department may inspect a trauma scene waste management
practitioner in either a routine or unannounced manner in order to
determine whether the practitioner should be registered and a new
or renewal permit should be issued to the practitioner under this
section or to investigate a complaint. The department may deny,
suspend, or revoke registration and the issuance of a permit if the
department determines that the practitioner is not able to engage
in the cleanup, handling, and transport of trauma scene waste in a
manner that will protect the public health, safety, and welfare and
the environment. A trauma scene waste management practitioner is
entitled to notice and a hearing in the manner prescribed in
section 92 of the administrative procedures act of 1969, 1969 PA
306, MCL 24.292, if the department determines that it must suspend
or revoke registration and the issuance of a permit under this
subsection.
(9) The department shall develop, maintain, and post on its
website a current list of registered trauma scene waste management
practitioners. The department shall periodically submit a current
list of registered trauma scene waste management practitioners to
local health agencies, local health officers, local environmental
health administrators, and county sheriffs. Upon request, the
department shall submit a current list of registered trauma scene
waste management practitioners to other public agencies and to the
general public.
Sec. 13819. (1) Upon review of a medical waste management plan
under section 13817(4) or a trauma scene waste management plan
under section 13816, the department may require a producing
facility or trauma scene waste management practitioner to modify
the
medical waste management its plan at any time the department
determines that the plan is not adequate to protect the public
health, safety, and welfare and the environment or is inconsistent
with state or federal law. Upon determining that the plan is
inadequate or inconsistent under this section, the department shall
notify the producing facility or the trauma scene waste management
practitioner in writing of its determination and the specific
modifications necessary for compliance. The producing facility or
trauma scene waste management practitioner shall modify the plan
within 10 days after receipt of the notice from the department.
(2) The department may issue a warning to a producing facility
or trauma scene waste management practitioner that fails to modify
a plan within the 10-day period.
Sec. 13830. (1) The department shall promulgate rules to
prescribe training standards for both medical and nonmedical
personnel who handle medical waste in producing facilities and for
trauma scene waste management practitioners.
(2) Each producing facility and trauma scene waste management
practitioner shall train its personnel who handle medical waste
pursuant to the rules promulgated under subsection (1).
Sec. 13831. (1) Except as provided in subsection (2), a person
who violates this part or a rule promulgated under this part is
subject to an administrative fine of not more than $2,500.00 for
each violation and an additional fine of not more than $1,000.00
for each day during which the violation continues. For a first
offense, the department of public health or the department of
natural resources may postpone the levying of a fine under this
subsection for not more than 45 days or until the violation is
corrected, whichever occurs first.
(2) A person who fails to register with the department or have
a medical waste management plan available for inspection in
compliance with sections 13813, 13816, and 13817 is subject to an
administrative fine of $500.00.
(3)
A person who violates this act part
may be enjoined by a
court of competent jurisdiction from continuing the violation.