February 22, 2005, Introduced by Senators GARCIA, HAMMERSTROM and BARCIA and referred to the Committee on Health Policy.
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending sections 13501, 13505, 13506, 13515, 13517, 13521,
13522, 13525, 13535, and 13536 (MCL 333.13501, 333.13505,
333.13506, 333.13515, 333.13517, 333.13521, 333.13522, 333.13525,
333.13535, and 333.13536), sections 13501, and 13522 as amended by
1994 PA 100 and section 13521 as amended by 1989 PA 56, and by
adding part 135A; and to repeal acts and parts of acts.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
Sec. 13501. (1) As used in this part:
(a) "Department" means the department of environmental
quality.
(b) (a)
"General license" means
a license, effective
pursuant to rules promulgated by the department without the filing
of an application, to transfer, acquire, own, possess, or use
quantities of, or devices or equipment utilizing, radioactive
material.
(c) (b)
"Ionizing radiation"
means gamma rays and x-rays,
alpha particles, beta particles, high speed electrons, neutrons,
protons, high speed ions, and other high speed nuclear particles.
(c)
"Mammography" means radiography of the breast for the
purpose
of enabling a physician to determine the presence, size,
location,
and extent of cancerous or potentially cancerous tissue
in
the breast.
(d)
"Mammography authorization" means authorization under
section
13523 to use a radiation machine for mammography.
(e)
"Mammography interpreter" means an individual who meets
the
requirements set forth in section 13523(2)(g) and is
responsible
for evaluating and interpreting mammographic images.
(d) (f)
"Person" means a person
as defined in section 1106
or a governmental entity.
(e) (g)
"Radioactive material"
means a solid, liquid, or gas
material
which that emits ionizing radiation spontaneously.
(f) (h)
"Radiography" means the
making of a film or other
record of an internal structure of the body by passing x-rays or
gamma rays through the body to act on film or other image receptor.
(g) (i)
"Registration" means
registration of a source of
ionizing radiation in writing with the department.
(h) (j)
"Source of ionizing
radiation" means a device or
material that emits ionizing radiation.
(i) (k)
"Specific license" means
a license issued by the
department to use, manufacture, produce, transfer, receive,
acquire, own, or possess quantities of, or devices or equipment
utilizing, radioactive material.
(2) In addition, article 1 contains general definitions and
principles of construction applicable to all articles in this code.
Sec. 13505. A person shall not manufacture, produce,
transport, transfer, dispose of, acquire, own, possess, or use a
radioactive material or other source of ionizing radiation unless
the
person is licensed , registered, or
exempted under this part
or is licensed or exempted by the department in accordance with
rules
promulgated pursuant to by
the department under this part.
or
unless exempted by this part.
Sec. 13506. Sections 13505 and 13515 to 13536 do not apply to
the following sources or conditions, except as noted:
(a)
Electrical or other equipment or material not intended
primarily
to produce radiation which, by nature of design, does not
produce
radiation at the point of nearest approach at a weekly rate
higher
than 1/10 the appropriate limit generally accepted by the
medical
profession for any critical organ exposed. The production
testing
or production servicing of the equipment is not exempt.
(b)
A radiation machine during process of manufacture or in
storage
or transit. The production testing or production servicing
of
the machine is not exempt.
(a) (c)
A radioactive material while being
transported under
the jurisdiction of and in conformity with regulations adopted by
the nuclear regulatory commission or the United States department
of transportation, or their successors, specifically applicable to
the
transportation of such the radioactive material.
(b) (d)
Sound waves, radio waves, and
visible, infrared, or
ultraviolet light.
(c) (e)
A production or utilization
facility, as defined in
the
federal atomic energy act of 1954, 42 U.S.C. USC 2011
to
2281
2297g-4, or a source of ionizing radiation used in or in
connection with the operation of a production or utilization
facility pursuant to a license from the federal nuclear regulatory
commission
or its successor thereto agency.
However, the
department may collect radiation data and perform environmental
monitoring in connection with the operation of the facility in
accordance with this part.
(d) (f)
A source material, by-product
material, or special
nuclear material over which the federal nuclear regulatory
commission
or a its successor thereto agency
has exclusive
regulatory
jurisdiction under the federal atomic energy act of
1954, 42 USC 2011 to 2297g-4, which jurisdiction has not been
transferred
to this state pursuant to an agreement under Act No.
54
of the Public Acts of 1965, being sections 3.801 and 3.802 of
the
Michigan Compiled Laws 1965 PA 54, MCL 3.801 to
3.802.
Sec. 13515. (1) The department is designated as the radiation
control agency of this state and shall coordinate radiation control
programs of state departments acting within their statutory
authorities.
(2) Pursuant to rules promulgated under this part, the
department
shall require licensing and registration of
radioactive materials and other sources of ionizing radiation.
(3) The department shall develop and conduct programs for
evaluation and control of hazards associated with the use of
radioactive materials and other sources of ionizing radiation.
Sec. 13517. (1) The department may enter at all reasonable
times upon private or public property upon which sources of
ionizing radiation are reasonably believed to be located, with the
permission
of the owner or custodian thereof of the property, to
determine if there is compliance with or violation of this part or
a rule promulgated under this part or compliance with or a
violation of a license issued under this part.
(2) If the department has reasonable cause or probable cause
to believe that a violation of this part or a rule promulgated
under this part or a violation of a license issued under this part
is being committed on private or public property or that there
exists on the property evidence of a violation, and permission to
enter
thereon on the property is denied by the owner or custodian
thereof
of the property, the
department may apply to the proper
judicial
officer under Act No. 189 of the Public Acts of 1966,
being
sections 780.651 to 780.659 of the Michigan Compiled Laws
1966 PA 189, MCL 780.651 to 780.659, for a warrant commanding the
sheriff or a law enforcement officer, with the aid of the
department, to search the property and seize any source of ionizing
radiation that is possessed, controlled, or used wholly or
partially in violation of this part or a rule promulgated under
this part or in violation of a license issued under this part, or
any evidence of a violation of this part or a rule or license.
Sec. 13521. (1) The department shall promulgate rules
providing
for general or specific licenses or registration, or
exemption
from licensing or registration, for radioactive
materials and other sources of ionizing radiation. The rules shall
provide
for amendment, suspension, or revocation of licenses. In
connection
with those promulgating rules under this
subsection,
the
department may promulgate rules to establish requirements for
record keeping, permissible levels of exposure, notification and
reports of accidents, protective measures, technical qualifications
of personnel, handling, transportation, storage, waste disposal,
posting and labeling of hazardous sources and areas, surveys, and
monitoring.
(2) The rules promulgated under subsection (1) shall not limit
the intentional exposure of patients to radiation for the purpose
of lawful therapy or research conducted by licensed health
professionals.
(3)
The department shall promulgate rules specifying the
minimum
training and performance standards for an individual using
a
radiation machine for mammography as set forth in section 13523.
Sec. 13522. (1) In promulgating rules pursuant to this part,
the department shall avoid requiring dual licensing, insofar as
practical. Rules promulgated by the department may provide for
recognition of other state or federal licenses as the department
considers
desirable. , subject to registration requirements
prescribed
by the department. A person who,
on the effective date
of
an agreement under Act No. 54 of the Public Acts of 1965, being
sections
3.801 to 3.802 of the Michigan Compiled Laws 1965 PA 54,
MCL 3.801 to 3.802, possesses a license issued by the federal
government for a source of ionizing radiation of the type for which
the state assumes regulatory responsibility under the agreement, is
considered to possess an identical license issued pursuant to this
part, which license expires either 90 days after receipt of a
written notice of termination from the department or on the date of
expiration stated in the federal license, whichever occurs first.
(2) The department may promulgate rules to establish a
schedule of fees to be paid by applicants for licenses for
radioactive materials and devices and equipment utilizing the
radioactive materials.
(3) Except as otherwise provided in this subsection, the
department may promulgate rules to establish a schedule of fees to
be paid by an applicant for a license for other sources of ionizing
radiation
and the renewal of the license. , and by a person
possessing
sources of ionizing radiation that are subject to
registration.
The registration or registration renewal fee for a
radiation
machine registered under this part is $45.00 for the
first
veterinary or dental x-ray or electron tube and $25.00 for
each
additional veterinary or dental x-ray or electron tube
annually,
or $75.00 annually per nonveterinary or nondental x-ray
or
electron tube. The department shall not assess a fee for the
amendment
of a radiation machine registration certificate. In
addition,
the department shall assess a fee of $100.00 for each
follow-up
inspection due to noncompliance during the same year.
The
department may accept a written certification from the licensee
or
registrant that the items of
noncompliance have been corrected
instead of performing a follow-up inspection. If the department
does not inspect a source of ionizing radiation for a period of 5
consecutive
years, the licensee or registrant of the source of
ionizing
radiation does not have to pay further license or
registration
fees as to that source of ionizing
radiation until
the
first license or registration renewal date following the time
an inspection of the source of ionizing radiation is made.
(4) A fee collected under this part shall be deposited in the
state treasury and credited to the general fund of this state.
(5)
Except as otherwise provided in subsection (6), the
department
shall assess the following nonrefundable fees in
connection
with mammography authorization:
(a)
Inspection, per radiation machine................... $ 100.00
(b)
Reinspection for reinstatement of mammography
authorization,
per radiation machine......................... $ 100.00
(c)
Department evaluation of compliance with section
13523(2)(a),
per radiation machine........................... $ 700.00
Each
reevaluation of a radiation machine due to failure
during
the previous evaluation, relocation of the radiation
machine,
or similar changes that could affect earlier evaluation
results..................................................... $
300.00.
(6)
If an applicant for mammography authorization submits an
evaluation
report issued by the American college of radiology that
evidences
compliance with section 13523(2)(a), the department shall
waive
the fee under subsection (5) for department evaluation of
compliance
with that provision.
(5) (7)
Except as otherwise provided in subsections
subsection (3), and (6), the department shall not waive a
fee
required under this section.
(6) (8)
The department shall adjust on an
annual basis the
fees
prescribed by subsections subsection (3) and (5) by an
amount determined by the state treasurer to reflect the cumulative
annual percentage change in the Detroit consumer price index, not
to exceed 5%. As used in this subsection, "Detroit consumer price
index" means the most comprehensive index of consumer prices
available for the Detroit area from the bureau of labor statistics
of the United States department of labor.
Sec. 13525. A municipality or a department, agency, or
official
of a municipality may shall not license , or
regulate
,
or require the registration of a
radioactive material or other
source of ionizing radiation.
Sec. 13535. A person who violates this part or a rule
promulgated under this part or who fails to obtain or comply with
conditions
of licensure or registration under this part is guilty
of a misdemeanor, punishable by imprisonment for not more than 180
days, or a fine of not more than $10,000.00, or both. A court may
fine a person not more than $2,000.00 for each violation of this
part.
Each day a violation continues shall be is a separate
violation.
Sec. 13536. If, after thorough investigation by the
department, it is the judgment of the department that a person has
engaged
in or is about to engage in an act or practice which that
constitutes a violation of this part or of a rule or order
promulgated or issued under this part, the attorney general, at the
request
of the department, shall make application apply
to the
appropriate circuit court for an order enjoining the act or
practice or for an order directing compliance with this part or a
rule
or order promulgated or issued pursuant to under
this part.
PART 135A. RADIATION MACHINE CONTROL
Sec. 13551. (1) As used in this part:
(a) "Department" means the department of community health.
(b) "Ionizing radiation" means gamma rays and x-rays, alpha
particles, beta particles, high speed electrons, neutrons, protons,
high speed ions, and other high speed nuclear particles.
(c) "Mammography" means radiography of the breast for the
purpose of enabling a physician to determine the presence, size,
location, and extent of cancerous or potentially cancerous tissue
in the breast.
(d) "Mammography authorization" means authorization under
section 13573 to use a radiation machine for mammography.
(e) "Mammography interpreting physician" means an allopathic
physician or an osteopathic physician licensed under article 15 who
is responsible for evaluating and interpreting mammographic images
and who meets all of the following requirements:
(i) Except as otherwise provided in this subparagraph, is
certified in radiology or diagnostic radiology by the American
board of radiology or the American osteopathic board of radiology,
has been eligible for certification in radiology or diagnostic
radiology for not more than 3 years, or is certified or determined
to be qualified in radiology or diagnostic radiology by another
professional organization approved by the department.
(ii) Shall have successfully completed not less than 3 months
of formal training in reading mammograms with instruction in
medical radiation physics, radiation effects, and radiation
protection and has documentation of successful completion of the
training that is satisfactory to the department. For purposes of
this subparagraph, the department may accept time spent in a
residency program that includes specific training in mammography if
the individual has documentation of the residency program that is
satisfactory to the department.
(iii) Shall have initial training that includes documented
interpretation of not less than 240 mammographic examinations in
the 6 months immediately preceding the performance of independent
interpretation.
(iv) Shall have interpreted or multi-read not less than 960
mammographic examinations during the 24 months immediately
preceding the date of the mammography facility's annual inspection
or the last day of the calendar quarter preceding that inspection,
or any day in between those 2 days. The mammography facility shall
choose 1 of the 3 dates to determine the 24-month period of this
subparagraph.
(v) Shall successfully complete or teach not less than 15
hours of continuing medical education every 3 years after the
effective date of the amendatory act that added this part in the
technical aspects or clinical aspects, or both, of mammography in
courses or programs approved by the individual's respective
specialty organization and licensing board and has documentation of
successful completion or teaching that is satisfactory to the
department.
(vi) Maintains annual records concerning outcome data for
correlation of positive mammograms to biopsies done, and the number
of cancers detected.
(f) "Mammography system" means the radiation machine used for
mammography; automatic exposure control devices; imaging systems;
image processor; darkroom; and viewboxes.
(g) "Non-ionizing radiation" means sound waves, radar waves,
microwaves, radio frequency fields, magnetic fields, and visible,
infrared, or ultraviolet light.
(h) "Non-ionizing radiation device" means a machine or device
that produces non-ionizing radiation in intensities or frequencies
subject to regulation by department rule.
(i) "Person" means a person as defined in section 1106 or a
governmental entity.
(j) "Radiation machine" means a machine or device that
produces ionizing radiation in energies or intensities subject to
regulation by department rule.
(k) "Radiography" means the making of a film or other record
of an internal structure of the body by passing x-rays through the
body to act on film or other image receptor.
(l) "Registration" means registration of a radiation machine in
writing with the department.
(2) In addition, article 1 contains general definitions and
principles of construction applicable to all articles in this code.
Sec. 13555. A person shall not manufacture, produce,
transport, transfer, dispose of, acquire, own, possess, or use a
radiation machine unless the radiation machine is registered or
exempted by this part or by the department in accordance with rules
promulgated by the department under this part.
Sec. 13556. Sections 13555 and 13565 to 13586 do not apply to
the following sources or conditions, except as noted:
(a) Electrical or other equipment or material not intended
primarily to produce radiation which, by nature of design, does not
produce radiation at the point of nearest approach at a weekly rate
higher than 1/10 the appropriate limit generally accepted by the
medical profession for any critical organ exposed. The production
testing or production servicing of the equipment is not exempt.
(b) A radiation machine during process of manufacture or in
storage or transit. The production testing or production servicing
of the radiation machine is not exempt.
(c) Non-ionizing radiation sources or devices, unless
specifically addressed by rule promulgated by the department under
this part.
Sec. 13561. (1) The governor may enter into agreements with
the federal government, other states, or interstate agencies,
whereby the department shall perform for or on a cooperative basis
with the federal government, other states, or interstate agencies
inspections or other functions relating to control of radiation
machines.
(2) An agreement entered into under subsection (1) does not
transfer, delegate, or impose upon the department any power,
authority, or responsibility that is not fully consistent with this
part.
Sec. 13565. (1) The department is designated as the radiation
machine control agency of this state.
(2) Pursuant to rules promulgated under this part, the
department shall require registration of radiation machines.
(3) The department shall develop and conduct programs for
evaluation and control of hazards associated with the use of
radiation machines.
(4) The department may develop and conduct programs for
evaluation and control of hazards associated with the use of non-
ionizing radiation devices.
Sec. 13566. If the department finds that an emergency exists
requiring immediate action to protect occupational or public health
and safety, the department shall issue an order, with or without
notice or hearing, reciting the existence of the emergency and
providing for the protection of the public health and safety.
Notwithstanding this act or the administrative procedures act of
1969, the order is effective immediately. A person to whom the
order is directed shall comply with the order immediately. However,
upon request, the department shall grant the person a hearing on
the order or on an issue concerning the order within 15 days after
receipt of the request. On the basis of the findings of fact and
conclusions of law made at the hearing, the department shall
continue, modify, or revoke the order within 30 days after the
hearing.
Sec. 13567. (1) The department may enter at all reasonable
times upon private or public property upon which radiation machines
are reasonably believed to be located, with the permission of the
owner or custodian of the property, to determine if the radiation
machine is in compliance with this part and the rules promulgated
under this part.
(2) If the department has probable cause to believe that a
violation of this part or a rule promulgated under this part is
being committed on private or public property or that there exists
on the property evidence of such a violation, and permission to
enter on the property is denied by the owner or custodian of the
property, the department may make an affidavit for a search warrant
under 1966 PA 189, MCL 780.651 to 780.659. The search warrant
issued to the department under 1966 PA 189, MCL 780.651 to 780.659,
will command the sheriff or a law enforcement officer, with the aid
of the department, to search the property and seize the radiation
machine that is possessed, controlled, or used wholly or partially
in violation of this part or a rule promulgated under this part, or
evidence of a violation of this part or a rule promulgated under
this part.
Sec. 13571. (1) The department shall promulgate rules
providing for the registration of radiation machines. The
department may promulgate rules for the registration of non-
ionizing radiation devices. In promulgating rules under this
subsection, the department may establish requirements for exemption
from registration, record keeping, permissible levels of exposure,
notification and reports of accidents, protective measures,
technical qualifications of personnel, handling, posting and
labeling of hazardous machines, devices, and areas, surveys, and
monitoring.
(2) In promulgating rules under subsection (1), the department
shall not limit the intentional exposure of a patient to radiation
for the purpose of lawful therapy or research conducted by a
licensed health professional.
(3) The department shall promulgate rules specifying the
minimum training and performance standards for an individual using
a radiation machine for mammography as set forth in section 13573.
(4) The department shall promulgate rules specifying the
minimum training and performance standards for an individual using
a radiation machine for human screening or for diagnostic or
therapeutic purposes.
Sec. 13572. (1) Except as otherwise provided in this
subsection, the department may promulgate rules to establish a
schedule of fees to be paid by an applicant for the registration of
a radiation machine or a non-ionizing radiation device. The
registration or registration renewal fee for a radiation machine
registered under this part is $45.00 for the first veterinary or
dental x-ray or electron tube and $25.00 for each additional
veterinary or dental x-ray or electron tube annually, or $75.00
annually per nonveterinary or nondental x-ray or electron tube. The
department shall not assess a fee for the amendment of a radiation
machine registration certificate. In addition, the department shall
assess a fee of $100.00 for each follow-up inspection due to
noncompliance during the same year. The department may accept a
written certification from the registrant that the items of
noncompliance have been corrected instead of performing a follow-up
inspection. If the department does not inspect a radiation machine
or non-ionizing radiation device for a period of 5 consecutive
years, the registrant of the radiation machine or non-ionizing
radiation device does not have to pay further registration fees as
to that radiation machine or non-ionizing radiation device until
the first registration renewal date following the time an
inspection of the radiation machine or non-ionizing radiation
device is made.
(2) A fee collected under this part shall be deposited in the
state treasury and credited to the general fund of this state.
(3) Except as otherwise provided in subsection (4), the
department shall assess the following nonrefundable fees in
connection with mammography authorization:
(a) Inspection, per radiation machine................... $ 100.00
(b) Reinspection for reinstatement of mammography
authorization, per radiation machine......................... $ 100.00
(c) Department evaluation of compliance with section
13573(2)(a), per radiation machine........................... $ 700.00
(d) Each reevaluation of a radiation machine due to failure
during the previous evaluation, relocation of the radiation
machine, or similar changes that could affect earlier evaluation
results..................................................... $ 300.00.
(4) If an applicant for mammography authorization submits an
evaluation report issued by the American college of radiology that
evidences compliance with section 13573(2)(a), the department shall
waive the fee under subsection (3) for department evaluation of
compliance with that provision.
(5) Except as otherwise provided in subsections (1) and (4),
the department shall not waive a fee required under this section.
(6) The department shall adjust on an annual basis the fees
prescribed by subsections (1) and (3) by an amount determined by
the state treasurer to reflect the cumulative annual percentage
change in the Detroit consumer price index, not to exceed 5%. As
used in this subsection, "Detroit consumer price index" means the
most comprehensive index of consumer prices available for the
Detroit area from the bureau of labor statistics of the United
States department of labor.
Sec. 13573. (1) A person shall not use a radiation machine to
perform mammography unless the radiation machine is registered with
the department under department rules for registration of radiation
machines and is specifically authorized under this section for use
for mammography.
(2) The department shall authorize a radiation machine for use
for mammography if the radiation machine, the personnel operating
the radiation machine, and the facility in which the radiation
machine is used meet all of the following standards:
(a) The radiation machine and the facility in which the
radiation machine is used meet the criteria for the American
college of radiology mammography accreditation program dated
August, 1993 and amended 1995 (Res. 24, 53) and published by the
American college of radiology in the documents entitled "ACR
standards for the performance of screening mammography", which
documents and criteria are incorporated by reference, excluding the
physician interpreter and the accreditation fee schedule. The
department shall make copies of those criteria available to the
public and may by rule adopt modified criteria. The department may
accept an evaluation report issued by the American college of
radiology as evidence that a radiation machine, the personnel
operating the radiation machine, and the facility in which the
radiation machine is used meet those criteria. If at any time the
department determines that it will not accept any evaluation
reports issued by the American college of radiology as evidence
that a radiation machine, the personnel operating the radiation
machine, and the facility in which the radiation machine is used
meet those criteria, the department shall promptly notify each
person who has registered a radiation machine used exclusively to
perform mammography under this part and the rules promulgated under
this part.
(b) The radiation machine, the film or other image receptor
used in the radiation machine, and the facility in which the
radiation machine is used meet the requirements set forth in
department rules for radiation machines.
(c) The radiation machine is specifically designed to perform
mammography.
(d) The facility in which the radiation machine is used does
all of the following:
(i) At least annually has a qualified radiation physicist
provide on-site consultation to the facility, including, but not
limited to, a complete evaluation of the entire mammography system
to ensure compliance with this part and the rules promulgated under
this part.
(ii) Maintains for at least 7 years records of the consultation
required in subparagraph (i) and the findings of the consultation.
(iii) Designates a mammography interpreting physician as the
lead interpreting physician. The designated physician is
responsible for the clinical aspects of the x-ray examinations and
other procedures related to mammography. The physician designated
under this subparagraph is also responsible for conducting an on-
site visit to each mammography station within the facility at least
monthly for the purpose of providing professional feedback
regarding clinical image quality and quality assurance procedures,
for review of quality control documentation, and for ensuring that
safe operating procedures are used in the delivery of mammographic
services. If the physician designated under this subparagraph
practices primarily outside of the facility, the physician shall
keep a log of each on-site visit signed by the physician. The chief
administrative officer of the facility or his or her designee may
request to view the log at any time.
(iv) Submits, as part of the application for authorization and
subsequent renewals, evidence of a surety bond, secured trust fund,
or other suitable secured instrument or mechanism that is approved
by the department and that insures proper patient mammography
record and film handling and transfer in the event of facility
closure. The facility shall attest that the method of coverage
chosen will completely cover all costs involved and will be
adjusted, as needed, accordingly.
(e) The radiation machine is used according to department
rules on patient radiation exposure and radiation dose levels.
(f) Each individual who operates the radiation machine can
demonstrate to the department that he or she is specifically
trained in mammography and meets the standards required by the
rules promulgated under section 13571(3) or is an allopathic
physician or an osteopathic physician.
(g) The x-ray images of each mammographic examination
performed with the radiation machine are interpreted by a
mammography interpreting physician.
(3) The department may issue a nonrenewable temporary
authorization for a radiation machine for use for mammography if
additional time is needed to allow submission of evidence
satisfactory to the department that the radiation machine, the
personnel operating the radiation machine, and the facility in
which the radiation machine is used meet the standards set forth in
subsection (2) for approval for mammography. A temporary
authorization granted under this subsection is effective for no
more than 12 months. The department may withdraw a temporary
authorization before its expiration if the radiation machine, the
personnel operating the radiation machine, or the facility in which
the radiation machine is used does not meet 1 or more of the
standards set forth in subsection (2).
(4) To obtain authorization from the department to use a
radiation machine for mammography, the person who owns or leases
the radiation machine or an authorized agent of the person shall
apply to the department for mammography authorization on an
application form provided by the department and shall provide all
of the information required by the department as specified on the
application form. A person who owns or leases more than 1 radiation
machine used for mammography shall obtain authorization for each
radiation machine. The department shall process and respond to an
application within 30 days after the date of receipt of the
application. Upon determining to grant mammography authorization
for a radiation machine, the department shall issue a certificate
of registration specifying mammography authorization for each
authorized radiation machine. A mammography authorization is
effective for 3 years contingent upon the radiation machine for
which the mammography authorization is issued, the personnel
operating the radiation machine, and the facility in which the
radiation machine is operated meeting 1 of the following
requirements:
(a) Maintaining continued accreditation by the American
college of radiology.
(b) Having an active accreditation application in process with
the American college of radiology.
(c) Maintaining approval or being in the process of obtaining
approval under a department evaluation process equivalent to that
described in subdivisions (a) and (b).
(5) No later than 90 days after initial mammography
authorization of a radiation machine under this section, the
department shall inspect the radiation machine. After that initial
inspection, the department shall annually inspect the radiation
machine and may inspect the radiation machine more frequently. The
department shall make reasonable efforts to coordinate the
inspections under this section with the department's other
inspections of the facility in which the radiation machine is
located.
(6) After each satisfactory inspection by the department, the
department shall issue a certificate of radiation machine
inspection or a similar document identifying the facility and
radiation machine inspected and providing a record of the date the
radiation machine was inspected. The facility shall post the
certificate or other document near the inspected radiation machine.
(7) The department may withdraw the mammography authorization
for a radiation machine if it does not meet 1 or more of the
standards set forth in subsection (2).
(8) The department shall provide an opportunity for a hearing
in connection with a denial or withdrawal of mammography
authorization.
(9) Upon a finding that a deficiency in a radiation machine
used for mammography or a violation of this part or the rules
promulgated under this part seriously affects the health, safety,
and welfare of individuals upon whom the radiation machine is used
for mammography, the department may issue an emergency order
summarily withdrawing the mammography authorization for the
radiation machine. The department shall incorporate its findings in
the order and shall provide an opportunity for a hearing within 5
working days after issuance of the order. The order is effective
during the proceedings.
(10) If the department withdraws the mammography authorization
for a radiation machine, the radiation machine shall not be used
for mammography. An application for reinstatement of a mammography
authorization shall be filed and processed in the same manner as an
application for mammography authorization under subsection (4),
except that the department shall not issue a reinstated certificate
of mammography registration until the department receives the
reinspection fee required under section 13572(3), inspects the
radiation machine, and determines that it meets the standards set
forth in subsection (2). The department shall conduct an inspection
required under this subsection no later than 60 days after
receiving a proper application for reinstatement of a mammography
authorization.
(11) In addition to the penalties provided in section 13585
and the reinspection fee required under section 13572, if a person
violates subsection (1), the department may impose an
administrative fine against the owner of the radiation machine or,
if a lessee of the radiation machine has effective control of the
radiation machine, the lessee, of not more than $500.00 for each
calendar week in which a mammography is performed in violation of
subsection (1). If a person continues to violate subsection (1) for
a period of 2 weeks after a fine is imposed under this subsection,
the department shall post a conspicuous notice on the unauthorized
radiation machine and at the entry to the facility where the
radiation machine is located warning the public that the facility
is performing mammography using a radiation machine that is a
substantial hazard to the public health.
(12) The department may promulgate rules necessary to
implement this section after consultation with the ionizing
radiation advisory committee established under section 13581.
Sec. 13574. (1) A facility in which a radiation machine is
located shall ensure that all individuals, except licensed members
of the healing arts, using the radiation machine for human
screening or for diagnostic or therapeutic purposes are adequately
instructed in the safe operating procedures of the radiation
machine, pursuant to this section. The facility shall ensure that
these individuals meet the specific requirements of this section.
The department may use interview, observation, or both, to
determine compliance with this section. A facility described in
this subsection shall maintain records in order to demonstrate
compliance with this section.
(2) Limited scope operators are limited in scope of practice
to only those procedures listed in subsection (6). Limited scope
operators shall meet the prerequisite qualifications, receive
training, and demonstrate competence as follows:
(a) Shall complete at least 48 hours of didactic instruction
in a formal program, approved by the department, as prescribed in
subsection (7).
(b) Achieve a passing score of 70% on the certification
examination for the limited scope of practice in radiography
developed by the American registry of radiologic technologists and
approved by the department in at least 1 but no more than 3 of the
limited scope categories of chest, extremities, skull/sinus, spine,
or podiatric. A facility needing to perform examinations in
addition to any 3 of these categories shall employ a comprehensive
scope operator according to subsection (3). A passing score on the
basic chiropractic x-ray technology examination given through the
American chiropractic registry of radiologic technologists and
approved by the department is considered to meet the requirements
of this subdivision for limited scope spinal radiography.
(c) Shall compete the clinical experience requirements in
subsection (8).
(d) Individuals who have been actively working as a medical x-
ray operator for at least 6 months before the effective date of
this part are exempt from the requirements of subdivision (c).
These individuals shall document completion of the didactic
training requirements in subdivision (a) and the examination
requirements in subdivision (b) within 3 years of the effective
date of this part.
(e) Shall obtain not less than 15 hours, in any 3-year period,
of continuing education in the technical or clinical, or both,
aspects and related subjects of x-ray examinations in their scope
of practice.
(3) Comprehensive scope operators are not limited in scope of
practice for performing medical x-ray procedures. Comprehensive
scope operators must meet the prerequisite qualifications, receive
training, and demonstrate competence as follows:
(a) Shall meet the standards for issuance of a registration
certificate as a registered technologist from the American registry
of radiologic technologists or other nationally recognized
accreditation body. These standards, entitled "Rules and
Regulations", as revised in February, 1990, and "By-Laws", as
revised in September, 1989, published by the American registry of
radiologic technologists, are incorporated by reference. These
standards are available from the radiation safety section, Michigan
department of community health, 611 west Ottawa street, p.o. box
30664, Lansing, Michigan, 48909, at no charge. The standards are
also available from the American registry of radiologic
technologists, 1255 Northland drive, St. Paul, Minnesota, 55120, at
no charge. A determination by the American registry of radiologic
technologists that an individual meets its respective standards for
issuance of a registration certificate is prima facie evidence to
the department that the individual complies with the standards.
(b) Shall, if the scope of practice includes specialties such
as computed tomography or radiation therapy, meet the standards for
issuance of advanced certification in that speciality from the
American registry of radiologic technologists, as approved by the
department.
(4) Dental x-ray operators, except dentists licensed under
article 15, shall meet the prerequisite qualifications, receive
training, and demonstrate competence as follows:
(a) Shall complete at least 36 hours of didactic instruction
in a formal program, approved by the department, as prescribed in
subsection (9).
(b) Graduates of a dental hygiene or dental assisting program
certified by the commission on dental accreditation and approved by
the department are considered to have met the requirements of
subdivision (a).
(c) Individuals who have been actively working as a dental x-
ray operator for at least 6 months before the effective date of
this part shall document completion of the didactic training
requirements of subdivision (a) or (b) within 3 years after the
effective date of this part.
(5) Veterinary x-ray operators, unless under the direct
supervision of a veterinarian licensed under article 15, shall meet
the prerequisite qualifications, receive training, and demonstrate
competence as follows:
(a) Shall complete at least 36 hours of didactic instruction
in a formal program approved by the department as prescribed in
subsection (10).
(b) Individuals who have been actively working as a veterinary
x-ray operator for at least 6 months before the effective date of
this part shall document completion of the didactic training
requirements in subdivision (a) within 3 years after the effective
date of this part.
(6) Limited scope x-ray operators, as described in subsection
(2), shall perform only the following specific x-ray examinations:
(a) The following x-ray examinations of the extremities:
(i) Hand and fingers....................... PA, lateral, oblique.
(ii) Wrists................................ PA, lateral, oblique.
(iii) Forearm........................................ AP, lateral.
(iv) Elbow.......................................... AP, lateral.
(v) Humerus........................................ AP, lateral.
(vi) Foot and toes......................... AP, lateral, oblique.
(vii) Ankle................................ AP, lateral, oblique.
(viii) Tibia-fibula.................................. AP, lateral.
(ix) Knee........................................... AP, lateral.
(x) Femur.......................................... AP, lateral.
(b) The following x-ray examinations of the spine:
(i) Cervical spine........................ AP, lateral, odontoid,
non-trauma, swimmer's non-trauma.
(ii) Thoracic spine........... AP, lateral, swimmer's non-trauma.
(iii) Lumbar spine.................... AP, lateral, L5-S1 lateral.
(c) PA, AP, lateral, oblique, decubitus, and apical lordotic
x-ray examinations of the chest.
(d) DP and lateral x-ray examinations of the ankle.
(e) The following x-ray examinations of the skull and sinus:
(i) Entire skull.
(ii) Paranasal sinuses.
(iii) Facial bones.
(iv) Mandible and temporomandibular joint.
(7) An individual described in subsections (2) and (3) shall
complete a minimum of 48 hours of didactic training in a formal
training course. After successful completion of the course, the
individual shall pass an examination appropriate to his or her
scope of practice and complete the clinical experience requirements
prescribed in subsection (8). The formal training course is subject
to department approval and shall provide instruction in all of the
following subjects:
(a) Radiation protection including all of the following:
(i) Patient protection.
(ii) Personnel protection.
(iii) Radiation exposure and monitoring.
(b) Equipment operation and maintenance including all of the
following:
(i) Radiographic unit components.
(ii) Principles of x-ray production.
(iii) Recognition of malfunctions.
(c) Image production and evaluation including all of the
following:
(i) Selection of technique factors.
(ii) Film processing and quality assurance.
(iii) Evaluation of radiographs.
(d) Patient care including all of the following:
(i) Legal and professional responsibilities.
(ii) Patient education, safety, and comfort.
(iii) Prevention and control of infection.
(iv) Patient monitoring.
(e) Radiographic procedure positioning.
(8) An individual who completes the requirements of subsection
(7) shall complete 1 month of clinical training during which time
he or she may perform the x-ray examinations allowed under
subsection (6) only under the direct supervision of the physician
in charge, a comprehensive scope operator, or a limited scope
operator with no less than 3 years of experience. An individual
described in this subsection shall be trained in proper imaging
procedures as listed below:
(a) Selection of appropriate film size.
(b) Selection of appropriate technique factors.
(c) Use of correct source-to-image distance.
(d) Establishment of proper direction of central ray.
(e) Execution of proper patient position.
(f) Collimation of the x-ray beam as appropriate.
(g) Providing gonadal shielding if appropriate.
(h) Using correct film markers.
(i) Giving proper patient instruction.
(j) Placing patient information correctly on the film.
(k) Completing examination in a timely manner.
(l) Obtaining desired anatomy and positioning results on the
film.
(m) Obtaining appropriate contrast and density on the film.
(n) Identifying visible motion or film artifacts and repeating
exam if needed.
(9) An individual described in subsection (4) shall complete a
minimum of 36 hours of didactic radiology training in a formal
training course. The course is subject to department approval and
shall provide instruction in all of the following subjects:
(a) Radiation protection, including all of the following:
(i) Patient protection.
(ii) Personnel protection.
(iii) Radiation exposure and monitoring.
(b) Equipment operation and maintenance, including all of the
following:
(i) Radiographic unit components.
(ii) Principles of x-ray production.
(iii) Recognition of malfunctions.
(c) Image production and evaluation, including all of the
following:
(i) Selection of technique factors.
(ii) Film processing and quality assurance.
(iii) Evaluation, mounting, and labeling of radiographs.
(d) Patient care, including all of the following:
(i) Legal and professional responsibilities.
(ii) Patient education, safety, and comfort.
(iii) Prevention and control of infection.
(iv) Patient monitoring.
(e) Radiographic procedure positioning and film selection,
including all of the following:
(i) Periapical.
(ii) Bitewing.
(iii) Occlusal.
(iv) Panoramic.
(v) Cephalometric, orthodontic only.
(vi) Transcranial and TMJ, oral/maxillofacial only.
(10) An individual described in subsection (5) shall complete
a minimum of 36 hours of didactic training in a formal training
course. The course is subject to department approval and shall
provide instruction in all of the following subjects:
(a) Radiation protection, including all of the following:
(i) Personnel protection.
(ii) radiation exposure and monitoring.
(b) Equipment operation and maintenance, including all of the
following:
(i) Radiographic unit components.
(ii) Principles of x-ray production.
(iii) Recognition of malfunctions.
(c) Image production and evaluation, including all of the
following:
(i) Selection of technique factors.
(ii) Film processing and quality assurance.
(iii) Evaluation and labeling of radiographs.
(iv) Infection control.
(d) Radiographic procedure positioning.
Sec. 13575. A municipality or a department, agency, or
official of a municipality shall not license, regulate, or require
the registration of a radiation machine or a non-ionizing radiation
device.
Sec. 13581. The director shall appoint an ionizing radiation
advisory committee. Members of the committee serve at the pleasure
of the director. The committee shall furnish to the department
technical advice the committee considers desirable or the
department may reasonably request on matters relating to the
radiation machine control program.
Sec. 13585. A person who violates this part or a rule
promulgated under this part or who fails to obtain or comply with a
condition of registration under this part is guilty of a
misdemeanor punishable by imprisonment for not more than 180 days,
or a fine of not more than $10,000.00, or both. A court may fine a
person not more than $2,000.00 for each violation of this part.
Each day a violation continues is a separate violation.
Sec. 13586. If, after thorough investigation by the
department, it is the judgment of the department that a person has
engaged in or is about to engage in an act or practice that
constitutes a violation of this part or a rule or order promulgated
or issued under this part, the attorney general, at the request of
the department, shall apply to the appropriate circuit court for an
order enjoining the act or practice or for an order directing
compliance with this part or a rule or order promulgated or issued
under this part.
Enacting section 1. Sections 13523 and 13531 of the public
health code, 1978 PA 368, MCL 333.13523 and 333.13531, are
repealed.