Bill Text: MI HB6105 | 2019-2020 | 100th Legislature | Introduced
Bill Title: Health: other; requirements for radiologic personnel and machines; revise. Amends secs. 13501, 13505, 13506, 13515, 13517, 13521, 13522, 13525, 13535 & 13536 of 1978 PA 368 (MCL 333.13501 et seq.); adds part 135a & repeals secs. 13523, 13524, 13527 & 13531 of 1978 PA 368 (MCL 333.13523 et seq.).
Spectrum: Partisan Bill (Republican 1-0)
Status: (Introduced - Dead) 2020-09-01 - Bill Electronically Reproduced 08/17/2020 [HB6105 Detail]
Download: Michigan-2019-HB6105-Introduced.html
HOUSE BILL NO. 6105
August 17, 2020, Introduced by Rep. Wakeman 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 2018 PA 544, and by adding part 135a; and to repeal acts and parts of acts.
the people of the state of michigan enact:
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Sec. 13501. (1) As used in this part:
(a) "Department" means the department of labor and economic opportunity.
(b) (a) "General license" means a license, effective pursuant to under 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, 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 that term 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 X-rays or gamma rays through the body to
act on film or other image
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receptor.
(i) "Registration" means registration of a source of ionizing radiation in writing with the department.
(g) (j) "Source of ionizing radiation"
means a device or material that emits ionizing radiation.
(h) (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
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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 federal Nuclear Regulatory Commission or
the United States department of
transportation, 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 facility or utilization facility , as defined in the federal atomic energy act of 1954, 42 U.S.C.
2011 to 2281 , or a source of ionizing radiation used in or in
connection with the operation of a production facility or utilization facility pursuant to a
license from the federal nuclear regulatory
commission 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. As used in this subdivision, "production
facility" and "utilization facility" mean those terms as defined
in 42 USC 2014.
(d) (f) A source material, by-product material,
or special nuclear material over which the federal nuclear regulatory commission 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 2297h-13, 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.
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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 In a manner required by 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 on private or public property upon on 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 a 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
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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 promulgated under this part or a license issued under this part.
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 must
provide for amendment, suspension, or revocation of licenses. In connection with those promulgating rules , subject to
section 13527, 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) must 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 under 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
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considers
desirable. , subject to registration
requirements prescribed by the department. A person who, that, 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 this state assumes regulatory
responsibility under the agreement, is considered to possess an identical
license issued pursuant to under 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
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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 an item of noncompliance have has 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 must 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.
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(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, Consumer Price Index, not to exceed 5%. As used in
this subsection, "Detroit consumer price
index" Consumer Price Index"
means the most comprehensive index of consumer prices available
for the Detroit area from the bureau of labor
statistics Bureau of Labor Statistics
of the United States department of labor.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
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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.
RADIATION MACHINE CONTROL
Sec. 13551. (1) As used in this part:
(a) "Department" means the department of labor and economic opportunity.
(b)
"Director" means the director of the department or his or her
designee.
(c) "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.
(d) "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.
(e) "Mammography authorization" means authorization under section 13573 to use a radiation machine for mammography.
(f) "Mammography interpreting physician" means a physician who meets the requirements set forth in section 13573(2)(g) and is responsible for evaluating and interpreting mammographic images.
(g) "Mammography system" means the radiation machine used for mammography, automatic exposure control devices, imaging systems, image processor, darkroom, and viewboxes.
(h) "Non-ionizing radiation" means sound waves, radar waves, microwaves, radio frequency fields, magnetic fields, and visible, infrared, or ultraviolet light.
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(i) "Non-ionizing radiation device" means a machine or device that produces non-ionizing radiation in intensities or frequencies subject to regulation by the department by rule.
(j) "Person" means that term as defined in section 1106 or a governmental entity.
(k) "Radiation machine" means a machine or device that produces ionizing radiation in energies or intensities subject to regulation by the department by rule.
(l) "Radiography" means the making of a film, digital image, 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.
(m) "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 that, 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
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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 a 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 on 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) In the manner required by 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.
(5) The department shall require certification of individuals who operate radiation machines for diagnostic, instructional, or therapeutic purposes and who are not otherwise exempted from this
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part.
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, on 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 on private or public property on 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,
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must 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
subsection (2), the department may promulgate rules to establish a schedule of
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fees to be paid by an applicant for the registration of a
radiation machine or a non-ionizing radiation device. The department shall
promulgate rules to establish a schedule of fees to be paid by an applicant for
certification to operate a radiation machine.
(2) The registration or registration renewal fee for a radiation machine registered under this part is $75.00 annually per 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.
(3) A fee collected under this part must be deposited in the state treasury and credited to the general fund of this state.
(4) Except as otherwise provided in subsection (5), 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 |
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|
(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. |
(5) 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 (4) for department evaluation of compliance with that provision.
(6) Except as otherwise provided in subsections (2) and (5), the department shall not waive a fee required under this section.
(7) The department shall adjust on an annual basis the fees prescribed in this section 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
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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.
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(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 physician licensed under part 170 or 175 as the lead interpreting physician. The physician designated under this subparagraph is responsible for the clinical aspects of the X-ray examinations and other procedures related to mammography and 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. The physician designated under this subparagraph shall meet the requirements of subdivision (g)(i) and (v).
(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
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by the department and that ensures 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 a physician licensed under part 170 or 175.
(g) The X-ray images of each mammographic examination performed with the radiation machine are interpreted by a mammography interpreting physician who is a physician licensed under part 170 or 175 and who meets all of the following requirements:
(i) 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) Has 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
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includes specific training in mammography if the individual has documentation of the residency program that is satisfactory to the department.
(iii) Has 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) Has 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) Has successfully completed or taught 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.
(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
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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 not longer 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. On 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 on 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.
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(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) On 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,
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and welfare of individuals on 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 must 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(4), 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,
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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. 13573a.(1) If a patient's
mammogram demonstrates dense breast tissue, a person who provides mammography
services in this state shall provide notification to the patient that includes,
but is not limited to, the following information, in the summary of the written
report of the results of a mammography examination that is sent directly to a
patient under 42 USC 263b:
"Your
mammogram shows that your breast tissue is dense. Dense breast tissue is very
common and is not abnormal. However, dense breast tissue can make it harder to
find cancer through a mammogram. Also, dense breast tissue may increase your
risk for breast cancer. This information about the result of your mammogram is
given to you to raise your awareness. Use this information to discuss with your
health care provider whether other supplemental tests in addition to your
mammogram may be appropriate for you, based on your individual risk. A report
of your results was sent to your ordering physician. If you are self-referred,
a report of your results was sent to you in addition to this summary.".
(2)
As used in this section, "dense breast tissue" means heterogeneously
or extremely dense breast tissue as defined in nationally recognized guidelines
or systems for breast imaging reporting of mammography screening including, but
not limited to,
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the breast imaging reporting and data system
established by the American College of Radiology. If, after the effective date
of the amendatory act that added this section, new terms are defined in revised
guidelines or systems for breast imaging reporting of mammography screening,
and the department determines that those new terms are more appropriate for the
purposes of the information required to be provided under this section, the
department, by order, may update the definition of dense breast tissue under
this subsection to use those new terms. On issuance, the department shall
forward an order issued under this subsection to the legislature.
Sec. 13574. (1) A limited scope operator is limited in scope of practice to only those procedures listed in subsection (3). A limited scope operator 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 (4).
(b) Shall 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 (2). 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
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of this subdivision for limited scope spinal radiography.
(c) Shall complete the clinical experience requirements in subsection (5). An individual who has been actively working as a medical X-ray operator for at least 6 months before the effective date of this part is exempt from the requirements of this subdivision. The individual shall document completion of the didactic training requirements in subdivision (a) and the examination requirements in subdivision (b) within 3 years after the effective date of this part.
(d) 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.
(2) A comprehensive scope operator is not limited in scope of practice for performing medical X-ray procedures. A comprehensive scope operator 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 of the department at no charge. The standards are also available from the American Registry of Radiologic Technologists, at no charge. A determination by the American Registry of Radiologic Technologists that an individual meets its respective standards for issuance of a
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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 specialty from the American Registry of Radiologic Technologists, as approved by the department.
(3) A limited scope X-ray operator described in subsection (1) shall perform only the following specific X-ray examinations:
(a) The following X-ray examinations of the extremities:
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(i) Hand and fingers......... |
PA, lateral, oblique. |
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(ii) Wrists.................. |
PA, lateral, oblique. |
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(iii) Forearm................. |
AP, lateral. |
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(iv) Elbow................... |
AP, lateral. |
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(v) Humerus................. |
AP, lateral. |
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(vi) Foot and toes........... |
AP, lateral, oblique. |
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(vii) Ankle................... |
AP, lateral, oblique. |
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(viii) Tibia-fibula........... |
AP, lateral. |
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(ix) Knee.................... |
AP, lateral. |
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(x) Femur................... |
AP, lateral. |
(b) The following X-ray examinations of the spine:
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(i) Cervical spine........... |
AP, lateral, odontoid, non-trauma, swimmer's non-trauma. |
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(ii) Thoracic spine.......... |
AP, lateral, swimmer's non-trauma. |
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(iii) Lumbar spine............ |
AP, lateral, L5-S1 lateral. |
(c) PA, AP, lateral, oblique, decubitus, and apical lordotic X-ray examinations of the chest.
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(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.
(4) An individual described in subsections (1) and (2) 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 (5). 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.
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(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.
(5) An individual who completes the requirements of subsection (4) shall complete 1 month of clinical training during which time he or she may perform the X-ray examinations allowed under subsection (3) only under the direct supervision of the physician in charge, a comprehensive scope operator, or a limited scope operator with not less than 3 years of experience. An individual described in this subsection must 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
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exam if needed.
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. 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, 13524, 13527, and 13531 of the public health code, 1978 PA 368, MCL 333.13523, 333.13524, 333.13527, and 333.13531, are repealed.
