June 26, 2003, Introduced by Reps. Julian and Vander Veen 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:
1 Sec. 13501. (1) As used in this part:
2 (a) "General license" means a license, effective pursuant to
3 rules promulgated by the department without the filing of an
4 application, to transfer, acquire, own, possess, or use
5 quantities of, or devices or equipment utilizing, radioactive
6 material.
1 (b) "Ionizing radiation" means gamma rays and x-rays, alpha
2 particles, beta particles, high speed electrons, neutrons,
3 protons, high speed ions, and other high speed nuclear
4 particles.
5 (c)
"Mammography" means radiography of the breast for the
6 purpose of enabling a
physician to determine the presence, size,
7 location, and extent
of cancerous or potentially cancerous tissue
8 in the breast.
9 (d)
"Mammography authorization" means authorization under
10 section 13523 to use a
radiation machine for mammography.
11 (e)
"Mammography interpreter" means an individual who meets
12 the requirements set
forth in section 13523(2)(g) and is
13 responsible for
evaluating and interpreting mammographic images.
14 (c) (f) "Person"
means a person as defined in section 1106
15 or a governmental entity.
16 (d) (g) "Radioactive
material" means a solid, liquid, or
17 gas material which that
emits ionizing radiation
18 spontaneously.
19 (e) (h) "Radiography"
means the making of a film or other
20 record of an internal structure of the body by passing x-rays or
21 gamma rays through the body to act on film or other image
22 receptor.
23 (f) (i) "Registration"
means registration of a source of
24 ionizing radiation in writing with the department.
25 (g) (j) "Source
of ionizing radiation" means a device or
26 material that emits ionizing radiation.
27 (h) (k) "Specific
license" means a license issued by the
1 department to use, manufacture, produce, transfer, receive,
2 acquire, own, or possess quantities of, or devices or equipment
3 utilizing, radioactive material.
4 (2) In addition, article 1 contains general definitions and
5 principles of construction applicable to all articles in this
6 code.
7 Sec. 13505. A person shall not manufacture, produce,
8 transport, transfer, dispose of, acquire, own, possess, or use a
9 radioactive material or other source of ionizing radiation unless
10 the person is licensed ,
registered, or exempted under this
11 part or is licensed or exempted by the department in accordance
12 with rules promulgated pursuant
to by the department under this
13 part. or
unless exempted by this part.
14 Sec. 13506. Sections 13505 and 13515 to 13536 do not apply
15 to the following sources or conditions, except as noted:
16 (a) Electrical or
other equipment or material not intended
17 primarily to produce
radiation which, by nature of design, does
18 not produce radiation
at the point of nearest approach at a
19 weekly rate higher
than 1/10 the appropriate limit generally
20 accepted by the
medical profession for any critical organ
21 exposed. The
production testing or production servicing of the
22 equipment is not
exempt.
23 (b) A radiation
machine during process of manufacture or in
24 storage or transit.
The production testing or production
25 servicing of the
machine is not exempt.
26 (a) (c) A
radioactive material while being transported
27 under the jurisdiction of and in conformity with regulations
1 adopted by the nuclear regulatory commission or the United States
2 department of transportation, or their successors, specifically
3 applicable to the
transportation of such the radioactive
4 material.
5 (b) (d) Sound
waves, radio waves, and visible, infrared,
6 or ultraviolet light.
7 (c) (e) A
production or utilization facility, as defined
8 in the federal atomic
energy act of 1954, 42 U.S.C. 2011 to
9 2281 chapter 1073, 68 Stat. 919, or a source of
ionizing
10 radiation used in or in connection with the operation of a
11 production or utilization facility pursuant to a license from the
12 federal nuclear
regulatory commission or its successor thereto
13 agency. However, the department may collect radiation data and
14 perform environmental monitoring in connection with the operation
15 of the facility in accordance with this part.
16 (d) (f) A
source material, by-product material, or special
17 nuclear material over which the federal nuclear regulatory
18 commission or a its
successor thereto agency has exclusive
19 regulatory jurisdiction
under the federal atomic energy act of
20 1954, chapter 1073, 68 Stat. 919, which jurisdiction has not been
21 transferred to this state
pursuant to an agreement under Act
22 No. 54 of the Public
Acts of 1965, being sections 3.801 and
23 3.802 of the Michigan
Compiled Laws 1965 PA 54, MCL
3.801 to
24 3.802.
25 Sec. 13515. (1) The department is designated as the
26 radiation control agency of this state and shall coordinate
27 radiation control programs of state departments acting within
1 their statutory authorities.
2 (2) Pursuant to rules promulgated under this part, the
3 department shall require
licensing and registration of
4 radioactive materials and other sources of ionizing radiation.
5 (3) The department shall develop and conduct programs for
6 evaluation and control of hazards associated with the use of
7 radioactive materials and other sources of ionizing radiation.
8 Sec. 13517. (1) The department may enter at all reasonable
9 times upon private or public property upon which sources of
10 ionizing radiation are reasonably believed to be located, with
11 the permission of the
owner or custodian thereof of the
12 property, to determine if there is compliance with or violation
13 of this part or a rule promulgated under this part or compliance
14 with or a violation of a license issued under this part.
15 (2) If the department has reasonable cause or probable cause
16 to believe that a violation of this part or a rule promulgated
17 under this part or a violation of a license issued under this
18 part is being committed on private or public property or that
19 there exists on the property evidence of a violation, and
20 permission to enter thereon
on the property is denied by the
21 owner or custodian thereof
of the property, the department may
22 apply to the proper
judicial officer under Act No. 189 of the
23 Public Acts of 1966,
being sections 780.651 to 780.659 of the
24 Michigan Compiled Laws
1966 PA 189, MCL 780.651 to
780.659, for
25 a warrant commanding the sheriff or a law enforcement officer,
26 with the aid of the department, to search the property and seize
27 any source of ionizing radiation that is possessed, controlled,
1 or used wholly or partially in violation of this part or a rule
2 promulgated under this part or in violation of a license issued
3 under this part, or any evidence of a violation of this part or a
4 rule or license.
5 Sec. 13521. (1) The department shall promulgate rules
6 providing for general or
specific licenses or registration, or
7 exemption from licensing or
registration, for radioactive
8 materials and other sources of ionizing radiation. The rules
9 shall provide for amendment, suspension, or revocation of
10 licenses. In connection
with those promulgating rules under
11 this subsection, the
department may promulgate rules to
12 establish requirements for record keeping, permissible levels of
13 exposure, notification and reports of accidents, protective
14 measures, technical qualifications of personnel, handling,
15 transportation, storage, waste disposal, posting and labeling of
16 hazardous sources and areas, surveys, and monitoring.
17 (2) The rules promulgated under subsection (1) shall not
18 limit the intentional exposure of patients to radiation for the
19 purpose of lawful therapy or research conducted by licensed
20 health professionals.
21 (3) The
department shall promulgate rules specifying the
22 minimum training and
performance standards for an individual
23 using a radiation
machine for mammography as set forth in
24 section 13523.
25 Sec. 13522. (1) In promulgating rules pursuant to this
26 part, the department shall avoid requiring dual licensing,
27 insofar as practical. Rules promulgated by the department may
1 provide for recognition of other state or federal licenses as the
2 department considers
desirable. , subject to registration
3 requirements
prescribed by the department. A
person who, on the
4 effective date of an
agreement under Act No. 54 of the Public
5 Acts of 1965, being
sections 3.801 to 3.802 of the Michigan
6 Compiled Laws 1965 PA 54, MCL 3.801 to 3.802, possesses a
7 license issued by the federal government for a source of ionizing
8 radiation of the type for which the state assumes regulatory
9 responsibility under the agreement, is considered to possess an
10 identical license issued pursuant to this part, which license
11 expires either 90 days after receipt of a written notice of
12 termination from the department or on the date of expiration
13 stated in the federal license, whichever occurs first.
14 (2) The department may promulgate rules to establish a
15 schedule of fees to be paid by applicants for licenses for
16 radioactive materials and devices and equipment utilizing the
17 radioactive materials.
18 (3) Except as otherwise provided in this subsection, the
19 department may promulgate rules to establish a schedule of fees
20 to be paid by an applicant for a license for other sources of
21 ionizing radiation and
the renewal of the license. , and by a
22 person possessing
sources of ionizing radiation that are subject
23 to registration. The
registration or registration renewal fee
24 for a radiation
machine registered under this part is $45.00 for
25 the first veterinary
or dental x-ray or electron tube and $25.00
26 for each additional
veterinary or dental x-ray or electron tube
27 annually, or $75.00
annually per nonveterinary or nondental x-ray
1 or electron tube. The
department shall not assess a fee for the
2 amendment of a
radiation machine registration certificate. In
3 addition, the
department shall assess a fee of $100.00 for each
4 follow-up inspection
due to noncompliance during the same year.
5 The department may accept a written certification from the
6 licensee or registrant
that the items of noncompliance have
7 been corrected instead of performing a follow-up inspection. If
8 the department does not inspect a source of ionizing radiation
9 for a period of 5
consecutive years, the licensee or registrant
10 of the source of ionizing radiation does not have to pay further
11 license or
registration fees as to that source of ionizing
12 radiation until the first
license or registration renewal date
13 following the time an inspection of the source of ionizing
14 radiation is made.
15 (4) A fee collected under this part shall be deposited in the
16 state treasury and credited to the general fund of this state.
17 (5) Except as
otherwise provided in subsection (6), the
18 department shall
assess the following nonrefundable fees in
19 connection with
mammography authorization:
20 (a) Inspection,
per radiation machine........... $ 100.00
21 (b) Reinspection
for reinstatement of
22 mammography
authorization, per radiation machine..... $ 100.00
23 (c) Department
evaluation of compliance with
24 section 13523(2)(a),
per radiation machine........... $ 700.00
25 Each
reevaluation of a radiation machine due
26 to failure during the
previous evaluation, relocation
27 of the radiation
machine, or similar changes that
1 could affect earlier
evaluation results.............. $ 300.00.
2 (6) If an
applicant for mammography authorization submits an
3 evaluation report
issued by the American college of radiology
4 that evidences
compliance with section 13523(2)(a), the
5 department shall waive
the fee under subsection (5) for
6 department evaluation
of compliance with that provision.
7 (5) (7) Except
as otherwise provided in subsections
8 subsection (3), and
(6), the department shall not waive a fee
9 required under this section.
10 (6) (8) The
department shall adjust on an annual basis the
11 fees prescribed by subsections
subsection (3) and (5) by an
12 amount determined by the state treasurer to reflect the
13 cumulative annual percentage change in the Detroit consumer price
14 index, not to exceed 5%. As used in this subsection, "Detroit
15 consumer price index" means the most comprehensive index of
16 consumer prices available for the Detroit area from the bureau of
17 labor statistics of the United States department of labor.
18 Sec. 13525. A municipality or a department, agency, or
19 official of a
municipality may shall not license , or
20 regulate , or require
the registration of a radioactive
21 material or other source of ionizing radiation.
22 Sec. 13535. A person who violates this part or a rule
23 promulgated under this part or who fails to obtain or comply with
24 conditions of licensure or
registration under this part is
25 guilty of a misdemeanor, punishable by imprisonment for not more
26 than 180 days, or a fine of not more than $10,000.00, or both. A
27 court may fine a person not more than $2,000.00 for each
1 violation of this part.
Each day a violation continues shall
2 be is a separate violation.
3 Sec. 13536. If, after thorough investigation by the
4 department, it is the judgment of the department that a person
5 has engaged in or is about to engage in an act or practice
6 which that constitutes a violation of this part or of
a rule or
7 order promulgated or issued under this part, the attorney
8 general, at the request
of the department, shall make
9 application apply to the appropriate circuit court for an
order
10 enjoining the act or practice or for an order directing
11 compliance with this part or a rule or order promulgated or
12 issued pursuant to under
this part.
13 PART 135A. Radiation machine control
14 Sec. 13551. (1) As used in this part:
15 (a) "Ionizing radiation" means gamma rays and x-rays, alpha
16 particles, beta particles, high speed electrons, neutrons,
17 protons, high speed ions, and other high speed nuclear
18 particles.
19 (b) "Mammography" means radiography of the breast for the
20 purpose of enabling a physician to determine the presence, size,
21 location, and extent of cancerous or potentially cancerous tissue
22 in the breast.
23 (c) "Mammography authorization" means authorization under
24 section 13573 to use a radiation machine for mammography.
25 (d) "Mammography interpreting physician" means a physician
26 who meets the requirements set forth in section 13573(2)(g) and
27 is responsible for evaluating and interpreting mammographic
1 images.
2 (e) "Mammography system" means the radiation machine used for
3 mammography; automatic exposure control devices; imaging systems;
4 image processor; darkroom; and viewboxes.
5 (f) "Non-ionizing radiation" means sound waves, radar waves,
6 microwaves, radio frequency fields, magnetic fields, and visible,
7 infrared, or ultraviolet light.
8 (g) "Non-ionizing radiation device" means a machine or device
9 that produces non-ionizing radiation in intensities or
10 frequencies subject to regulation by department rule.
11 (h) "Person" means a person as defined in section 1106 or a
12 governmental entity.
13 (i) "Radiation machine" means a machine or device that
14 produces ionizing radiation in energies or intensities subject to
15 regulation by department rule.
16 (j) "Radiography" means the making of a film or other record
17 of an internal structure of the body by passing x-rays through
18 the body to act on film or other image receptor.
19 (k) "Registration" means registration of a radiation machine
20 in writing with the department.
21 (2) In addition, article 1 contains general definitions and
22 principles of construction applicable to all articles in this
23 code.
24 Sec. 13555. A person shall not manufacture, produce,
25 transport, transfer, dispose of, acquire, own, possess, or use a
26 radiation machine unless the radiation machine is registered or
27 exempted by this part or by the department in accordance with
1 rules promulgated by the department under this part.
2 Sec. 13556. Sections 13555 and 13565 to 13586 do not apply
3 to the following sources or conditions, except as noted:
4 (a) Electrical or other equipment or material not intended
5 primarily to produce radiation which, by nature of design, does
6 not produce radiation at the point of nearest approach at a
7 weekly rate higher than 1/10 the appropriate limit generally
8 accepted by the medical profession for any critical organ
9 exposed. The production testing or production servicing of the
10 equipment is not exempt.
11 (b) A radiation machine during process of manufacture or in
12 storage or transit. The production testing or production
13 servicing of the radiation machine is not exempt.
14 (c) Non-ionizing radiation sources or devices, unless
15 specifically addressed by rule promulgated by the department
16 under this part.
17 Sec. 13561. (1) The governor may enter into agreements with
18 the federal government, other states, or interstate agencies,
19 whereby the department shall perform for or on a cooperative
20 basis with the federal government, other states, or interstate
21 agencies inspections or other functions relating to control of
22 radiation machines.
23 (2) An agreement entered into under subsection (1) does not
24 transfer, delegate, or impose upon the department any power,
25 authority, or responsibility that is not fully consistent with
26 this part.
27 Sec. 13565. (1) The department is designated as the
1 radiation machine control agency of this state.
2 (2) Pursuant to rules promulgated under this part, the
3 department shall require registration of radiation machines.
4 (3) The department shall develop and conduct programs for
5 evaluation and control of hazards associated with the use of
6 radiation machines.
7 (4) The department may develop and conduct programs for
8 evaluation and control of hazards associated with the use of
9 non-ionizing radiation devices.
10 Sec. 13566. If the department finds that an emergency
11 exists requiring immediate action to protect occupational or
12 public health and safety, the department shall issue an order,
13 with or without notice or hearing, reciting the existence of the
14 emergency and providing for the protection of the public health
15 and safety. Notwithstanding this act or the administrative
16 procedures act of 1969, the order is effective immediately. A
17 person to whom the order is directed shall comply with the order
18 immediately. However, upon request, the department shall grant
19 the person a hearing on the order or on an issue concerning the
20 order within 15 days after receipt of the request. On the basis
21 of the findings of fact and conclusions of law made at the
22 hearing, the department shall continue, modify, or revoke the
23 order within 30 days after the hearing.
24 Sec. 13567. (1) The department may enter at all reasonable
25 times upon private or public property upon which radiation
26 machines are reasonably believed to be located, with the
27 permission of the owner or custodian of the property, to
1 determine if the radiation machine is in compliance with this
2 part and the rules promulgated under this part.
3 (2) If the department has probable cause to believe that a
4 violation of this part or a rule promulgated under this part is
5 being committed on private or public property or that there
6 exists on the property evidence of such a violation, and
7 permission to enter on the property is denied by the owner or
8 custodian of the property, the department may make an affidavit
9 for a search warrant under 1966 PA 189, MCL 780.651 to 780.659.
10 The search warrant issued to the department under 1966 PA 189,
11 MCL 780.651 to 780.659, will command the sheriff or a law
12 enforcement officer, with the aid of the department, to search
13 the property and seize the radiation machine that is possessed,
14 controlled, or used wholly or partially in violation of this part
15 or a rule promulgated under this part, or evidence of a violation
16 of this part or a rule promulgated under this part.
17 Sec. 13571. (1) The department shall promulgate rules
18 providing for the registration of radiation machines. The
19 department may promulgate rules for the registration of
20 non-ionizing radiation devices. In promulgating rules under this
21 subsection, the department may establish requirements for
22 exemption from registration, record keeping, permissible levels
23 of exposure, notification and reports of accidents, protective
24 measures, technical qualifications of personnel, handling,
25 posting and labeling of hazardous machines, devices, and areas,
26 surveys, and monitoring.
27 (2) In promulgating rules under subsection (1), the
1 department shall not limit the intentional exposure of a patient
2 to radiation for the purpose of lawful therapy or research
3 conducted by a licensed health professional.
4 (3) The department shall promulgate rules specifying the
5 minimum training and performance standards for an individual
6 using a radiation machine for mammography as set forth in section
7 13573.
8 (4) The department shall promulgate rules specifying the
9 minimum training and performance standards for an individual
10 using a radiation machine for human screening or for diagnostic
11 or therapeutic purposes.
12 Sec. 13572. (1) Except as otherwise provided in this
13 subsection, the department may promulgate rules to establish a
14 schedule of fees to be paid by an applicant for the registration
15 of a radiation machine or a non-ionizing radiation device. The
16 registration or registration renewal fee for a radiation machine
17 registered under this part is $45.00 for the first veterinary or
18 dental x-ray or electron tube and $25.00 for each additional
19 veterinary or dental x-ray or electron tube annually, or $75.00
20 annually per nonveterinary or nondental x-ray or electron tube.
21 The department shall not assess a fee for the amendment of a
22 radiation machine registration certificate. In addition, the
23 department shall assess a fee of $100.00 for each follow-up
24 inspection due to noncompliance during the same year. The
25 department may accept a written certification from the registrant
26 that the items of noncompliance have been corrected instead of
27 performing a follow-up inspection. If the department does not
1 inspect a radiation machine or non-ionizing radiation device for
2 a period of 5 consecutive years, the registrant of the radiation
3 machine or non-ionizing radiation device does not have to pay
4 further registration fees as to that radiation machine or
5 non-ionizing radiation device until the first registration
6 renewal date following the time an inspection of the radiation
7 machine or non-ionizing radiation device is made.
8 (2) A fee collected under this part shall be deposited in
9 the state treasury and credited to the general fund of this
10 state.
11 (3) Except as otherwise provided in subsection (4), the
12 department shall assess the following nonrefundable fees in
13 connection with mammography authorization:
14 (a) Inspection, per radiation machine........... $ 100.00
15 (b) Reinspection for reinstatement of
16 mammography authorization, per radiation machine..... $ 100.00
17 (c) Department evaluation of compliance with
18 section 13573(2)(a), per radiation machine........... $ 700.00
19 (d) Each reevaluation of a radiation machine due
20 to failure during the previous evaluation, relocation
21 of the radiation machine, or similar changes that
22 could affect earlier evaluation results.............. $ 300.00.
23 (4) If an applicant for mammography authorization submits an
24 evaluation report issued by the American college of radiology
25 that evidences compliance with section 13573(2)(a), the
26 department shall waive the fee under subsection (3) for
27 department evaluation of compliance with that provision.
1 (5) Except as otherwise provided in subsections (1) and (4),
2 the department shall not waive a fee required under this
3 section.
4 (6) The department shall adjust on an annual basis the fees
5 prescribed by subsections (1) and (3) by an amount determined by
6 the state treasurer to reflect the cumulative annual percentage
7 change in the Detroit consumer price index, not to exceed 5%. As
8 used in this subsection, "Detroit consumer price index" means the
9 most comprehensive index of consumer prices available for the
10 Detroit area from the bureau of labor statistics of the United
11 States department of labor.
12 Sec. 13573. (1) A person shall not use a radiation machine
13 to perform mammography unless the radiation machine is registered
14 with the department under department rules for registration of
15 radiation machines and is specifically authorized under this
16 section for use for mammography.
17 (2) The department shall authorize a radiation machine for
18 use for mammography if the radiation machine, the personnel
19 operating the radiation machine, and the facility in which the
20 radiation machine is used meet all of the following standards:
21 (a) The radiation machine and the facility in which the
22 radiation machine is used meet the criteria for the American
23 college of radiology mammography accreditation program dated
24 August, 1993 and amended 1995 (Res. 24, 53) and published by the
25 American college of radiology in the documents entitled "ACR
26 standards for the performance of screening mammography", which
27 documents and criteria are incorporated by reference, excluding
1 the physician interpreter and the accreditation fee schedule.
2 The department shall make copies of those criteria available to
3 the public and may by rule adopt modified criteria. The
4 department may accept an evaluation report issued by the American
5 college of radiology as evidence that a radiation machine, the
6 personnel operating the radiation machine, and the facility in
7 which the radiation machine is used meet those criteria. If at
8 any time the department determines that it will not accept any
9 evaluation reports issued by the American college of radiology as
10 evidence that a radiation machine, the personnel operating the
11 radiation machine, and the facility in which the radiation
12 machine is used meet those criteria, the department shall
13 promptly notify each person who has registered a radiation
14 machine used exclusively to perform mammography under this part
15 and the rules promulgated under this part.
16 (b) The radiation machine, the film or other image receptor
17 used in the radiation machine, and the facility in which the
18 radiation machine is used meet the requirements set forth in
19 department rules for radiation machines.
20 (c) The radiation machine is specifically designed to perform
21 mammography.
22 (d) The facility in which the radiation machine is used does
23 all of the following:
24 (i) At least annually has a qualified radiation physicist
25 provide on-site consultation to the facility, including, but not
26 limited to, a complete evaluation of the entire mammography
27 system to ensure compliance with this part and the rules
1 promulgated under this part.
2 (ii) Maintains for at least 7 years records of the
3 consultation required in subparagraph (i) and the findings of the
4 consultation.
5 (iii) Designates an allopathic physician or an osteopathic
6 physician licensed under article 15 as the lead interpreting
7 physician. The designated physician is responsible for the
8 clinical aspects of the x-ray examinations and other procedures
9 related to mammography. The physician designated under this
10 subparagraph is also responsible for conducting an on-site visit
11 to each mammography station within the facility at least monthly
12 for the purpose of providing professional feedback regarding
13 clinical image quality and quality assurance procedures, for
14 review of quality control documentation, and for ensuring that
15 safe operating procedures are used in the delivery of
16 mammographic services. If the physician designated under this
17 subparagraph practices primarily outside of the facility, the
18 physician shall keep a log of each on-site visit signed by the
19 physician. The chief administrative officer of the facility or
20 his or her designee may request to view the log at any time. The
21 physician designated under this subparagraph shall meet the
22 requirements of subdivision (g)(i) and (v).
23 (iv) Submits, as part of the application for authorization
24 and subsequent renewals, evidence of a surety bond, secured trust
25 fund, or other suitable secured instrument or mechanism that is
26 approved by the department and that insures proper patient
27 mammography record and film handling and transfer in the event of
1 facility closure. The facility shall attest that the method of
2 coverage chosen will completely cover all costs involved and will
3 be adjusted, as needed, accordingly.
4 (e) The radiation machine is used according to department
5 rules on patient radiation exposure and radiation dose levels.
6 (f) Each individual who operates the radiation machine can
7 demonstrate to the department that he or she is specifically
8 trained in mammography and meets the standards required by the
9 rules promulgated under section 13571(3) or is an allopathic
10 physician or an osteopathic physician.
11 (g) The x-ray images of each mammographic examination
12 performed with the radiation machine are interpreted by a
13 mammography interpreting physician who is an allopathic physician
14 or an osteopathic physician licensed under article 15 and who
15 meets all of the following requirements:
16 (i) Except as otherwise provided in this subparagraph, is
17 certified in radiology or diagnostic radiology by the American
18 board of radiology or the American osteopathic board of
19 radiology, has been eligible for certification in radiology or
20 diagnostic radiology for not more than 3 years, or is certified
21 or determined to be qualified in radiology or diagnostic
22 radiology by another professional organization approved by the
23 department.
24 (ii) Shall have successfully completed not less than 3 months
25 of formal training in reading mammograms with instruction in
26 medical radiation physics, radiation effects, and radiation
27 protection and has documentation of successful completion of the
1 training that is satisfactory to the department. For purposes of
2 this subparagraph, the department may accept time spent in a
3 residency program that includes specific training in mammography
4 if the individual has documentation of the residency program that
5 is satisfactory to the department.
6 (iii) Shall have initial training that includes documented
7 interpretation of not less than 240 mammographic examinations in
8 the 6 months immediately preceding the performance of independent
9 interpretation.
10 (iv) Shall have interpreted or multi-read not less than 960
11 mammographic examinations during the 24 months immediately
12 preceding the date of the mammography facility's annual
13 inspection or the last day of the calendar quarter preceding that
14 inspection, or any day in between those 2 days. The mammography
15 facility shall choose 1 of the 3 dates to determine the 24-month
16 period of this subparagraph.
17 (v) Shall successfully complete or teach not less than 15
18 hours of continuing medical education every 3 years after the
19 effective date of the amendatory act that added this part in the
20 technical aspects or clinical aspects, or both, of mammography in
21 courses or programs approved by the individual's respective
22 specialty organization and licensing board and has documentation
23 of successful completion or teaching that is satisfactory to the
24 department.
25 (vi) Maintains annual records concerning outcome data for
26 correlation of positive mammograms to biopsies done, and the
27 number of cancers detected.
1 (3) The department may issue a nonrenewable temporary
2 authorization for a radiation machine for use for mammography if
3 additional time is needed to allow submission of evidence
4 satisfactory to the department that the radiation machine, the
5 personnel operating the radiation machine, and the facility in
6 which the radiation machine is used meet the standards set forth
7 in subsection (2) for approval for mammography. A temporary
8 authorization granted under this subsection is effective for no
9 more than 12 months. The department may withdraw a temporary
10 authorization before its expiration if the radiation machine, the
11 personnel operating the radiation machine, or the facility in
12 which the radiation machine is used does not meet 1 or more of
13 the standards set forth in subsection (2).
14 (4) To obtain authorization from the department to use a
15 radiation machine for mammography, the person who owns or leases
16 the radiation machine or an authorized agent of the person shall
17 apply to the department for mammography authorization on an
18 application form provided by the department and shall provide all
19 of the information required by the department as specified on the
20 application form. A person who owns or leases more than 1
21 radiation machine used for mammography shall obtain authorization
22 for each radiation machine. The department shall process and
23 respond to an application within 30 days after the date of
24 receipt of the application. Upon determining to grant
25 mammography authorization for a radiation machine, the department
26 shall issue a certificate of registration specifying mammography
27 authorization for each authorized radiation machine. A
1 mammography authorization is effective for 3 years contingent
2 upon the radiation machine for which the mammography
3 authorization is issued, the personnel operating the radiation
4 machine, and the facility in which the radiation machine is
5 operated meeting 1 of the following requirements:
6 (a) Maintaining continued accreditation by the American
7 college of radiology.
8 (b) Having an active accreditation application in process
9 with the American college of radiology.
10 (c) Maintaining approval or being in the process of obtaining
11 approval under a department evaluation process equivalent to that
12 described in subdivisions (a) and (b).
13 (5) No later than 90 days after initial mammography
14 authorization of a radiation machine under this section, the
15 department shall inspect the radiation machine. After that
16 initial inspection, the department shall annually inspect the
17 radiation machine and may inspect the radiation machine more
18 frequently. The department shall make reasonable efforts to
19 coordinate the inspections under this section with the
20 department's other inspections of the facility in which the
21 radiation machine is located.
22 (6) After each satisfactory inspection by the department, the
23 department shall issue a certificate of radiation machine
24 inspection or a similar document identifying the facility and
25 radiation machine inspected and providing a record of the date
26 the radiation machine was inspected. The facility shall post the
27 certificate or other document near the inspected radiation
1 machine.
2 (7) The department may withdraw the mammography authorization
3 for a radiation machine if it does not meet 1 or more of the
4 standards set forth in subsection (2).
5 (8) The department shall provide an opportunity for a hearing
6 in connection with a denial or withdrawal of mammography
7 authorization.
8 (9) Upon a finding that a deficiency in a radiation machine
9 used for mammography or a violation of this part or the rules
10 promulgated under this part seriously affects the health, safety,
11 and welfare of individuals upon whom the radiation machine is
12 used for mammography, the department may issue an emergency order
13 summarily withdrawing the mammography authorization for the
14 radiation machine. The department shall incorporate its findings
15 in the order and shall provide an opportunity for a hearing
16 within 5 working days after issuance of the order. The order is
17 effective during the proceedings.
18 (10) If the department withdraws the mammography
19 authorization for a radiation machine, the radiation machine
20 shall not be used for mammography. An application for
21 reinstatement of a mammography authorization shall be filed and
22 processed in the same manner as an application for mammography
23 authorization under subsection (4), except that the department
24 shall not issue a reinstated certificate of mammography
25 registration until the department receives the reinspection fee
26 required under section 13572(3), inspects the radiation machine,
27 and determines that it meets the standards set forth in
1 subsection (2). The department shall conduct an inspection
2 required under this subsection no later than 60 days after
3 receiving a proper application for reinstatement of a mammography
4 authorization.
5 (11) In addition to the penalties provided in section 13585
6 and the reinspection fee required under section 13572, if a
7 person violates subsection (1), the department may impose an
8 administrative fine against the owner of the radiation machine
9 or, if a lessee of the radiation machine has effective control of
10 the radiation machine, the lessee, of not more than $500.00 for
11 each calendar week in which a mammography is performed in
12 violation of subsection (1). If a person continues to violate
13 subsection (1) for a period of 2 weeks after a fine is imposed
14 under this subsection, the department shall post a conspicuous
15 notice on the unauthorized radiation machine and at the entry to
16 the facility where the radiation machine is located warning the
17 public that the facility is performing mammography using a
18 radiation machine that is a substantial hazard to the public
19 health.
20 (12) The department may promulgate rules necessary to
21 implement this section after consultation with the ionizing
22 radiation advisory committee established under section 13581.
23 Sec. 13574. (1) A facility in which a radiation machine is
24 located shall ensure that all individuals, except licensed
25 members of the healing arts, using the radiation machine for
26 human screening or for diagnostic or therapeutic purposes are
27 adequately instructed in the safe operating procedures of the
1 radiation machine, pursuant to this section. The facility shall
2 ensure that these individuals meet the specific requirements of
3 this section. The department may use interview, observation, or
4 both, to determine compliance with this section. A facility
5 described in this subsection shall maintain records in order to
6 demonstrate compliance with this section.
7 (2) Limited scope operators are limited in scope of practice
8 to only those procedures listed in subsection (6). Limited scope
9 operators shall meet the prerequisite qualifications, receive
10 training, and demonstrate competence as follows:
11 (a) Shall complete at least 48 hours of didactic instruction
12 in a formal program, approved by the department, as prescribed in
13 subsection (7).
14 (b) Achieve a passing score of 70% on the certification
15 examination for the limited scope of practice in radiography
16 developed by the American registry of radiologic technologists
17 and approved by the department in at least 1 but no more than 3
18 of the limited scope categories of chest, extremities,
19 skull/sinus, spine, or podiatric. A facility needing to perform
20 examinations in addition to any 3 of these categories shall
21 employ a comprehensive scope operator according to subsection
22 (3). A passing score on the basic chiropractic x-ray technology
23 examination given through the American chiropractic registry of
24 radiologic technologists and approved by the department is
25 considered to meet the requirements of this subdivision for
26 limited scope spinal radiography.
27 (c) Shall compete the clinical experience requirements in
1 subsection (8).
2 (d) Individuals who have been actively working as a medical
3 x-ray operator for at least 6 months before the effective date of
4 this part are exempt from the requirements of subdivision (c).
5 These individuals shall document completion of the didactic
6 training requirements in subdivision (a) and the examination
7 requirements in subdivision (b) within 3 years of the effective
8 date of this part.
9 (e) Shall obtain not less than 15 hours, in any 3-year
10 period, of continuing education in the technical or clinical, or
11 both, aspects and related subjects of x-ray examinations in their
12 scope of practice.
13 (3) Comprehensive scope operators are not limited in scope
14 of practice for performing medical x-ray procedures.
15 Comprehensive scope operators must meet the prerequisite
16 qualifications, receive training, and demonstrate competence as
17 follows:
18 (a) Shall meet the standards for issuance of a registration
19 certificate as a registered technologist from the American
20 registry of radiologic technologists or other nationally
21 recognized accreditation body. These standards, entitled "Rules
22 and Regulations", as revised in February, 1990, and "By-Laws", as
23 revised in September, 1989, published by the American registry of
24 radiologic technologists, are incorporated by reference. These
25 standards are available from the radiation safety section,
26 Michigan department of consumer and industry services, 525 west
27 Ottawa street, p.o. box 30664, Lansing, Michigan, 48909, at no
1 charge. The standards are also available from the American
2 registry of radiologic technologists, 1255 Northland drive,
3 Mendota Heights, Minnesota, 55120, at no charge. A determination
4 by the American registry of radiologic technologists that an
5 individual meets its respective standards for issuance of a
6 registration certificate is prima facie evidence to the
7 department that the individual complies with the standards.
8 (b) Shall, if the scope of practice includes specialties
9 such as computed tomography or radiation therapy, meet the
10 standards for issuance of advanced certification in that
11 speciality from the American registry of radiologic
12 technologists, as approved by the department.
13 (4) Dental x-ray operators, except dentists licensed under
14 article 15, shall meet the prerequisite qualifications, receive
15 training, and demonstrate competence as follows:
16 (a) Shall complete at least 36 hours of didactic instruction
17 in a formal program, approved by the department, as prescribed in
18 subsection (9).
19 (b) Graduates of a dental hygiene or dental assisting
20 program certified by the commission on dental accreditation and
21 approved by the department are considered to have met the
22 requirements of subdivision (a).
23 (c) Individuals who have been actively working as a dental
24 x-ray operator for at least 6 months before the effective date of
25 this part shall document completion of the didactic training
26 requirements of subdivision (a) or (b) within 3 years after the
27 effective date of this part.
1 (5) Veterinary x-ray operators, unless under the direct
2 supervision of a veterinarian licensed under article 15, shall
3 meet the prerequisite qualifications, receive training, and
4 demonstrate competence as follows:
5 (a) Shall complete at least 36 hours of didactic instruction
6 in a formal program approved by the department as prescribed in
7 subsection (10).
8 (b) Individuals who have been actively working as a
9 veterinary x-ray operator for at least 6 months before the
10 effective date of this part shall document completion of the
11 didactic training requirements in subdivision (a) within 3 years
12 after the effective date of this part.
13 (6) Limited scope x-ray operators, as described in
14 subsection (2), shall perform only the following specific x-ray
15 examinations:
16 (a) The following x-ray examinations of the extremities:
17 (i) Hand and fingers................... PA, lateral, oblique.
18 (ii) Wrists............................ PA, lateral, oblique.
19 (iii) Forearm................................... AP, lateral.
20 (iv) Elbow...................................... AP, lateral.
21 (v) Humerus..................................... AP, lateral.
22 (vi) Foot and toes..................... AP, lateral, oblique.
23 (vii) Ankle............................ AP, lateral, oblique.
24 (viii) Tibia-fibula............................. AP, lateral.
25 (ix) Knee....................................... AP, lateral.
26 (x) Femur....................................... AP, lateral.
27 (b) The following x-ray examinations of the spine:
1 (i) Cervical spine.....................AP, lateral, odontoid,
2 non-trauma, swimmer's non-trauma.
3 (ii) Thoracic spine....... AP, lateral, swimmer's non-trauma.
4 (iii) Lumbar spine............... AP, lateral, L5-S1 lateral.
5 (c) PA, AP, lateral, oblique, decubitus, and apical lordotic
6 x-ray examinations of the chest.
7 (d) DP and lateral x-ray examinations of the ankle.
8 (e) The following x-ray examinations of the skull and sinus:
9 (i) Entire skull.
10 (ii) Paranasal sinuses.
11 (iii) Facial bones.
12 (iv) Mandible and temporomandibular joint.
13 (7) An individual described in subsections (2) and (3) shall
14 complete a minimum of 48 hours of didactic training in a formal
15 training course. After successful completion of the course, the
16 individual shall pass an examination appropriate to his or her
17 scope of practice and complete the clinical experience
18 requirements prescribed in subsection (8). The formal training
19 course is subject to department approval and shall provide
20 instruction in all of the following subjects:
21 (a) Radiation protection including all of the following:
22 (i) Patient protection.
23 (ii) Personnel protection.
24 (iii) Radiation exposure and monitoring.
25 (b) Equipment operation and maintenance including all of the
26 following:
27 (i) Radiographic unit components.
1 (ii) Principles of x-ray production.
2 (iii) Recognition of malfunctions.
3 (c) Image production and evaluation including all of the
4 following:
5 (i) Selection of technique factors.
6 (ii) Film processing and quality assurance.
7 (iii) Evaluation of radiographs.
8 (d) Patient care including all of the following:
9 (i) Legal and professional responsibilities.
10 (ii) Patient education, safety, and comfort.
11 (iii) Prevention and control of infection.
12 (iv) Patient monitoring.
13 (e) Radiographic procedure positioning.
14 (8) An individual who completes the requirements of
15 subsection (7) shall complete 1 month of clinical training during
16 which time he or she may perform the x-ray examinations allowed
17 under subsection (6) only under the direct supervision of the
18 physician in charge, a comprehensive scope operator, or a limited
19 scope operator with no less than 3 years of experience. An
20 individual described in this subsection shall be trained in
21 proper imaging procedures as listed below:
22 (a) Selection of appropriate film size.
23 (b) Selection of appropriate technique factors.
24 (c) Use of correct source-to-image distance.
25 (d) Establishment of proper direction of central ray.
26 (e) Execution of proper patient position.
27 (f) Collimation of the x-ray beam as appropriate.
1 (g) Providing gonadal shielding if appropriate.
2 (h) Using correct film markers.
3 (i) Giving proper patient instruction.
4 (j) Placing patient information correctly on the film.
5 (k) Completing examination in a timely manner.
6 (l) Obtaining desired anatomy and positioning results on the
7 film.
8 (m) Obtaining appropriate contrast and density on the film.
9 (n) Identifying visible motion or film artifacts and
10 repeating exam if needed.
11 (9) An individual described in subsection (4) shall complete
12 a minimum of 36 hours of didactic radiology training in a formal
13 training course. The course is subject to department approval
14 and shall provide instruction in all of the following subjects:
15 (a) Radiation protection, including all of the following:
16 (i) Patient protection.
17 (ii) Personnel protection.
18 (iii) Radiation exposure and monitoring.
19 (b) Equipment operation and maintenance, including all of the
20 following:
21 (i) Radiographic unit components.
22 (ii) Principles of x-ray production.
23 (iii) Recognition of malfunctions.
24 (c) Image production and evaluation, including all of the
25 following:
26 (i) Selection of technique factors.
27 (ii) Film processing and quality assurance.
1 (iii) Evaluation, mounting, and labeling of radiographs.
2 (d) Patient care, including all of the following:
3 (i) Legal and professional responsibilities.
4 (ii) Patient education, safety, and comfort.
5 (iii) Prevention and control of infection.
6 (iv) Patient monitoring.
7 (e) Radiographic procedure positioning and film selection,
8 including all of the following:
9 (i) Periapical.
10 (ii) Bitewing.
11 (iii) Occlusal.
12 (iv) Panoramic.
13 (v) Cephalometric, orthodontic only.
14 (vi) Transcranial and TMJ, oral/maxillofacial only.
15 (10) An individual described in subsection (5) shall complete
16 a minimum of 36 hours of didactic training in a formal training
17 course. The course is subject to department approval and shall
18 provide instruction in all of the following subjects:
19 (a) Radiation protection, including all of the following:
20 (i) Personnel protection.
21 (ii) radiation exposure and monitoring.
22 (b) Equipment operation and maintenance, including all of the
23 following:
24 (i) Radiographic unit components.
25 (ii) Principles of x-ray production.
26 (iii) Recognition of malfunctions.
27 (c) Image production and evaluation, including all of the
1 following:
2 (i) Selection of technique factors.
3 (ii) Film processing and quality assurance.
4 (iii) Evaluation and labeling of radiographs.
5 (iv) Infection control.
6 (d) Radiographic procedure positioning.
7 Sec. 13575. A municipality or a department, agency, or
8 official of a municipality shall not license, regulate, or
9 require the registration of a radiation machine or a non-ionizing
10 radiation device.
11 Sec. 13581. The director shall appoint an ionizing
12 radiation advisory committee. Members of the committee serve at
13 the pleasure of the director. The committee shall furnish to the
14 department technical advice the committee considers desirable or
15 the department may reasonably request on matters relating to the
16 radiation machine control program.
17 Sec. 13585. A person who violates this part or a rule
18 promulgated under this part or who fails to obtain or comply with
19 a condition of registration under this part is guilty of a
20 misdemeanor punishable by imprisonment for not more than 180
21 days, or a fine of not more than $10,000.00, or both. A court
22 may fine a person not more than $2,000.00 for each violation of
23 this part. Each day a violation continues is a separate
24 violation.
25 Sec. 13586. If, after thorough investigation by the
26 department, it is the judgment of the department that a person
27 has engaged in or is about to engage in an act or practice that
1 constitutes a violation of this part or a rule or order
2 promulgated or issued under this part, the attorney general, at
3 the request of the department, shall apply to the appropriate
4 circuit court for an order enjoining the act or practice or for
5 an order directing compliance with this part or a rule or order
6 promulgated or issued under this part.
7 Enacting section 1. Sections 13523 and 13531 of the public
8 health code, 1978 PA 368, MCL 333.13523 and 333.13531, are
9 repealed.