reglab/statecodes huggingface dataset:
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › MAMMOGRAPHY AUTHORIZATION › Section R. 333.5610 - Supplemental machine information; effect of failure to submit information

Current through Vol. 24-12, July 15, 2024
Rule 610.
(1)
						Upon notice from the department that an application for mammography
						authorization is complete and complies with these rules and at the specific
						request of the department, the applicant shall, within 45 days of the
						department's request, provide all of the following information for each
						radiation machine for which mammography authorization is being sought:
(a) Confirmation that a department-approved
						mammography phantom is on-site when mammography is performed and is used in the
						facility's ongoing quality control program.
(b) Processor or laser film printer quality
						control data and corrective actions, if any, taken as a result of that data for
						a 30-day period beginning after the date the application was sent to the
						department.
(c) An x-ray image of a
						department-approved mammography phantom which is taken during the 30-day period
						for which processor quality control data is required under subdivision (b) of
						this subrule. The phantom image shall be taken using routine machine settings
						being used by the facility for that mammography machine for a 4.2-centimeter
						compressed breast of average density. The phantom image shall be accompanied by
						documentation of the date that the image was taken and the machine settings
						that were used.
(d) Determinations
						of the half-value layer, radiation exposure at skin entrance, and mean
						glandular dose. These determinations shall be made with the use of a
						department-approved dosimetry device exposed on the phantom during the same
						exposure that is used to produce an x-ray image to be submitted under
						subdivision (c) of this subrule, or that are made by other methods as specified
						or approved by the department.
(e)
						A set of clinical images produced on or after the date that the application was
						sent to the department. Mammography images shall be without pathology for each
						of 2 representative patients, 1 with dense breasts and 1 with fatty breasts.
						Stereotactic breast biopsy images shall be from 1 calcification biopsy case
						that demonstrates accurate needle location and includes the cases corresponding
						mammograms. The submitted images shall meet all of the following:
(i) The cases are examples of the facilitys
						best work.
(ii) The images are from
						actual patients.
(iii) Both
						screen-film and digital images are labeled with the identification information
						required in R 333.5657 for mammography images or R 333.5683 for stereotactic
						breast biopsy images.
(iv) The lead
						interpreting physician reviews and approves the clinical images.
(f) A copy of the medical
						physicists most recent equipment survey report.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › MAMMOGRAPHY AUTHORIZATION › Section R. 333.5611 - Contracts for technical evaluation

Current through Vol. 24-12, July 15, 2024
Rule 611.
(1)
						In evaluating clinical image quality and acceptability for mammography
						authorization, upon receipt of the information required in R 333.5610(1)(e),
						the department may enter into any necessary contracts with mammography experts,
						submit the images to those experts for technical evaluation, and rely upon
						their expert evaluation in arriving at a department conclusion regarding image
						quality and acceptability in terms of granting or not granting mammography
						authorization.
(2) Technical
						parameters that are used in evaluating clinical image quality and acceptability
						pursuant to subrule (1) of this rule shall include judgments of all of the
						following:
(a) Positioning.
(b) Compression.
(c) Radiation exposure and dose
						level.
(d) Sharpness.
(e) Contrast.
(f) Noise.
(g) Exam identification.
(h) Artifacts.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › MAMMOGRAPHY AUTHORIZATION › Section R. 333.5612 - Notice of change in application information; authorization not transferable

Current through Vol. 24-12, July 15, 2024
Rule 612.
(1)
						A facility that is authorized to perform mammography shall notify the
						department, in writing, of any change in the information contained in the
						application or supporting material upon which authorization was granted or any
						change that affects the accuracy of information which is provided or obtained
						during the application and evaluation process for authorization. Changes that
						shall be reported include changes in any of the following:
(a) Facility ownership.
(b) Facility location.
(c) Mammography machine.
(d) Image modality.
(e) American college of radiology
						accreditation status.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › MAMMOGRAPHY AUTHORIZATION › Section R. 333.5613 - Authorization withdrawal; reinstatement

Current through Vol. 24-12, July 15, 2024
Rule 613.
(1)
						Three-year mammography authorization is subject to continued compliance with
						this part and the provisions of these rules. Authorization may be withdrawn
						based on evidence of noncompliance with this part and the provisions of these
						rules pursuant to 1969 PA 306, MCL 24.201 to 24.328.
(2) If the department withdraws the
						mammography authorization of a machine, the machine shall not be used for
						mammography. An application for reinstatement of a mammography authorization
						shall be filed and processed in the same manner as an application for
						mammography authorization under R 333.5607 and R 333.5608.
(3) The department shall not issue a
						reinstated mammography authorization until the department receives the
						reinspection fee, inspects the machine, and determines that the facility meets
						the standards in R 333.5605.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › PERSONNEL › Section R. 333.5626 - Scope of personnel requirements

Current through Vol. 24-12, July 15, 2024
Rule 626. The requirements of R 333.5627 to R 333.5634
						  apply to all personnel involved in any aspect of mammography, including but not
						  limited to, the production, processing, and interpretation of mammograms and
						  related quality assurance activities.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › PERSONNEL › Section R. 333.5627 - Interpreting physician initial qualifications

Current through Vol. 24-12, July 15, 2024
Rule 627. Before beginning to interpret mammograms
						  independently, an interpreting physician shall meet all of the following
						  requirements:
(a) Be licensed as a
						physician or osteopathic physician under article 15 of the act to practice
						medicine.
(b) Meet either of the
						following requirements:
(i) Be certified in
						radiology or diagnostic radiology by the American board of radiology, the
						American osteopathic board of radiology, or the royal college of physicians and
						surgeons of Canada; have been eligible for certification in radiology or
						diagnostic radiology for not more than 2 years; or, be certified or determined
						to be qualified in radiology or diagnostic radiology by another professional
						organization determined by the department to have procedures and requirements
						adequate to ensure that physicians certified by the body are competent to
						interpret radiological procedures, including mammography.
(ii) If the physician has been eligible for
						certification in radiology or diagnostic radiology for less than 2 years, he or
						she shall have had at least 3 months of documented formal training in the
						interpretation of mammograms and in topics related to mammography. The training
						shall include instruction in radiation physics, including radiation physics
						specific to mammography, radiation effects, and radiation protection. The
						mammographic interpretation component of the training shall be under the direct
						supervision of a physician who meets the requirements of this rule.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › PERSONNEL › Section R. 333.5628 - Interpreting physician continuing experience and education

Current through Vol. 24-12, July 15, 2024
Rule 628. An interpreting physician shall maintain his
						  or her qualifications by meeting the continuing experience and education
						  requirements of
						  21 C.F.R.
						  900.12(a)(1)(ii), "Personnel
						  - Interpreting physicians - Continuing experience and education"
						  (2000).
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › PERSONNEL › Section R. 333.5629 - Interpreting physician reestablishment of qualifications

Current through Vol. 24-12, July 15, 2024
Rule 629. An interpreting physician who failed to
						  maintain the required continuing experience or continuing education
						  requirements of R 333.5628 shall reestablish his or her qualifications before
						  resuming the independent interpretation of mammograms by meeting the
						  reestablishing qualifications requirements of
						  21 C.F.R.
						  900.12(a)(1)(iv), "Personnel
						  Interpreting physicians Reestablishing qualifications"
						  (2000).
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › PERSONNEL › Section R. 333.5630 - Radiologic technologists

Current through Vol. 24-12, July 15, 2024
Rule 630. All mammographic examinations shall be
						  performed by a radiologic technologist who meets the general requirements,
						  mammography requirements, continuing education requirements, and continuing
						  experience requirements of
						  21 C.F.R.
						  900.12(a)(2), "Radiologic
						  technologists" (2000), with the exception of
						  21 C.F.R.
						  900.12(a)(2)(i)(A).
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › PERSONNEL › Section R. 333.5634 - Medical physicists

Current through Vol. 24-12, July 15, 2024
Rule 634. A medical physicist who conducts surveys of
						  mammography facilities and provides oversight of a facilitys quality assurance
						  program shall meet the initial qualifications, continuing qualifications, and
						  reestablishing qualification requirements of
						  21 C.F.R.
						  900.12(a)(3), "Medical
						  physicists" (2000).
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › PERSONNEL › Section R. 333.5635 - Retention of personnel records

Current through Vol. 24-12, July 15, 2024
Rule 635. A mammography facility shall maintain records
						  to document the qualifications of all personnel who work at the facility as
						  interpreting physicians, radiologic technologists, or medical physicists. These
						  records shall be made available for review during department inspections.
						  Records of personnel no longer employed by the mammography facility shall be
						  kept on file until the next inspection following the employees termination has
						  been completed, and the department determines that the facility complies with
						  the personnel requirements.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › X-RAY EQUIPMENT › Section R. 333.5637 - X-ray equipment; requirements

Current through Vol. 24-12, July 15, 2024
Rule 637.
(1)
						The mammographic x-ray equipment shall be maintained in compliance with the
						applicable regulations in
						21 C.F.R.
						1020.30, "Diagnostic x-ray systems and their
						major components" (2007), and
						21 C.F.R.
						1020.31, "Radiographic equipment"
						(2005).
(2) The mammography
						machine, x-ray film, intensifying screens, film processing solutions, film
						illumination, and film masking devices shall meet the requirements of
						21 C.F.R.
						900.12(b), "Equipment"
						(2000).
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › X-RAY EQUIPMENT › Section R. 333.5655 - Enclosure requirements; use of mobile equipment

Current through Vol. 24-12, July 15, 2024
Rule 655.
(1)
						A fixed x-ray equipment enclosure shall meet the requirements of R
						333.5331.
(2) For mammography, the
						operator's barrier shall provide radiation protection that is equivalent to not
						less than 0.5 millimeter of lead when the maximum tube potential is less than
						or equal to 35 kilovolts and 0.8 millimeter of lead when the maximum tube
						potential is greater than 35 kilovolts.
(3) An individual operating a mobile or
						portable mammography machine shall wear a protective apron of a minimum 0.5
						millimeter lead equivalence unless shielding is provided as specified in
						subrule (2) of this rule.
(4)
						Mobile or portable mammography equipment used routinely in 1 location shall be
						considered a fixed installation and shall meet the requirements of R
						333.5331.
(5) Mobile or portable
						mammography equipment shall not be used for routine mammography in hospitals or
						private offices of practitioners of the healing arts. This equipment shall be
						used only when it is medically inadvisable to move a patient to a fixed
						mammographic installation.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › X-RAY EQUIPMENT › Section R. 333.5656 - Conditions of operation

Current through Vol. 24-12, July 15, 2024
Rule 656. The operation of a mammography x-ray machine
						  shall meet the requirements of R 333.5333.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › MEDICAL RECORDS AND MAMMOGRAPHY REPORTS › Section R. 333.5657 - Medical records and mammography reports

Current through Vol. 24-12, July 15, 2024
Rule 657. A mammography facility shall comply with
						  21 C.F.R.
						  900.12(c), "Medical records
						  and mammography reports" (2000), except that the reference to retention of
						  records in
						  21 C.F.R.
						  900.12(c)(4)(i) is changed
						  from "not less than 5 years" to "not less than 7 years" pursuant to MCL
						  333.20175.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › QUALITY ASSURANCE › Section R. 333.5658 - Quality assurance - general

Current through Vol. 24-12, July 15, 2024
Rule 658. A mammography facility shall comply with
						  21 C.F.R.
						  900.12(d), "Quality
						  assurance general" (2000).
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › QUALITY ASSURANCE › Section R. 333.5667 - Quality assurance - equipment

Current through Vol. 24-12, July 15, 2024
Rule 667. A mammography facility shall comply with
						  21 C.F.R.
						  900.12(e), "Quality
						  assurance equipment" (2000).
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › QUALITY ASSURANCE › Section R. 333.5668 - Quality assurance - mammography medical outcomes audit; mammographic procedure and techniques for mammography of patients with breast implants; consumer complaint mechanism; clinical image quality

Current through Vol. 24-12, July 15, 2024
Rule 668. A mammography facility shall comply with
						  21 C.F.R.
						  900.12(f), "Quality
						  assurance mammography medical outcomes audit" (2000);
						  21 C.F.R.
						  900.12(g), "Mammographic
						  procedure and techniques for mammography of patients with breast implants"
						  (2000);
						  21 C.F.R.
						  900.12(h), "Consumer
						  complaint mechanism" (2000) and
						  21 C.F.R.
						  900.12(i), "Clinical image
						  quality" (2000).
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › QUALITY ASSURANCE › Section R. 333.5669 - Alternative requirements for personnel, x-ray equipment, medical records and mammography reports, and quality assurance

Current through Vol. 24-12, July 15, 2024
Rule 669. The department may accept alternatives to a
						  quality standard under
						  21 C.F.R.
						  900.12 that have been approved by the U.S.
						  food and drug administration under
						  21
						  C.F.R. 900.18, "Alternative requirements for
						  § 900.12quality standards" (2000).
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › STEREOTACTIC BREAST BIOPSY PERSONNEL › Section R. 333.5674 - Radiologic technologists

Current through Vol. 24-12, July 15, 2024
Rule 674. All stereotactic breast biopsy procedures
						  shall be performed by a radiologic technologist who meets all of the following
						  requirements:
(a) Initial
						qualifications. Before beginning to perform stereotactic breast biopsy
						procedures independently, a technologist shall do all of the following:
(i) Meet the requirements of R
						333.5630.
(ii) Have 3 hours of
						category A continuing education units in stereotactic breast biopsy.
(iii) Have performed 5 stereotactic breast
						biopsy procedures under supervision of a stereotactic breast biopsy physician
						or a qualified stereotactic breast biopsy technologist.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › STEREOTACTIC BREAST BIOPSY PERSONNEL › Section R. 333.5675 - Medical physicists

Current through Vol. 24-12, July 15, 2024
Rule 675. A stereotactic breast biopsy medical
						  physicist shall meet all of the following requirements:
(a) Initial qualifications. Before
						independently performing surveys of stereotactic breast biopsy facilities a
						medical physicist shall have complied with all of the following:
(i) Met the requirements of R
						333.5634.
(ii) Have performed 1
						hands-on stereotactic breast biopsy physics survey under a qualified
						stereotactic breast biopsy medical physicist or 3 independent stereotactic
						breast biopsy surveys before April 17, 2013.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › X-RAY EQUIPMENT › Section R. 333.5676 - Equipment requirements

Current through Vol. 24-12, July 15, 2024
Rule 676.
(1)
						The mammographic x-ray equipment shall be maintained in compliance with the
						applicable regulations in
						21 C.F.R.
						1020.30, "Diagnostic x-ray systems and their
						major components" (2007), and
						21 C.F.R.
						1020.31, "Radiographic equipment"
						(2005).
(2) A machine that is used
						for stereotactic breast biopsy shall be 1 of the following:
(a) A radiation machine that is specifically
						designed to perform stereotactic breast biopsy.
(b) A mammography machine with a specially
						designed add-on device for breast biopsy.
(c) A mammography machine that exclusively
						uses lateral arm devices if the needle can be seen in 2 ways in relation to the
						target lesion.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › X-RAY EQUIPMENT › Section R. 333.5677 - Enclosures; use of mobile equipment

Current through Vol. 24-12, July 15, 2024
Rule 677.
(1)
						A fixed x-ray equipment enclosure shall comply with R 333.5331.
(2) For stereotactic breast biopsy, the
						operator's barrier shall provide radiation protection that is equivalent to not
						less than 0.5 millimeter of lead when the maximum tube potential is less than
						or equal to 35 kilovolts and 0.8 millimeter of lead when the maximum tube
						potential is greater than 35 kilovolts.
(3) An individual operating mobile or
						portable stereotactic breast biopsy equipment shall wear a protective apron of
						a minimum 0.5 millimeter lead equivalence unless shielding is provided as
						specified in subrule (2) of this rule.
(4) Mobile or portable stereotactic breast
						biopsy equipment used routinely in 1 location shall be considered a fixed
						installation and shall comply with the requirements of R 333.5331.
(5) Mobile or portable stereotactic breast
						biopsy equipment shall not be used for routine mammography in hospitals or
						private offices of physicians or osteopathic physicians. This equipment shall
						be used only when it is medically inadvisable to move a patient to a fixed
						mammographic installation.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › X-RAY EQUIPMENT › Section R. 333.5678 - Conditions of operation

Current through Vol. 24-12, July 15, 2024
Rule 678. The operation of a mammography x-ray machine
						  shall comply with R 333.5333.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › MEDICAL RECORDS AND STEREOTACTIC BREAST BIOPSY REPORTS › Section R. 333.5679 - Report contents

Current through Vol. 24-12, July 15, 2024
Rule 679. A stereotactic breast biopsy facility shall
						  prepare a written report of the results of each stereotactic breast biopsy
						  procedure. The stereotactic breast biopsy report shall include all of the
						  following information:
(a) The name of
						the patient and an additional unique patient identifier.
(b) The date of the procedure.
(c) The name of the stereotactic breast
						biopsy physician who conducted the procedure.
(d) The procedure performed.
(e) Designation of the left or right
						breast.
(f) Description and
						location of the lesion.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › MEDICAL RECORDS AND STEREOTACTIC BREAST BIOPSY REPORTS › Section R. 333.5681 - Communication of stereotactic breast biopsy results to health care providers

Current through Vol. 24-12, July 15, 2024
Rule 681. When a patient has a referring health care
						  provider or a patient has named a health care provider, the stereotactic breast
						  biopsy facility shall provide a written report of the stereotactic breast
						  biopsy procedure, including the items listed in R 333.5679, to that health care
						  provider not later than 30 days after the date that the stereotactic breast
						  biopsy procedure was performed.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › MEDICAL RECORDS AND STEREOTACTIC BREAST BIOPSY REPORTS › Section R. 333.5682 - Record keeping

Current through Vol. 24-12, July 15, 2024
Rule 682.
(1)
						A facility that performs stereotactic breast biopsy procedures shall comply
						with both of the following:
(a) Maintain
						stereotactic breast biopsy images and reports in a permanent medical record of
						the patient for a period of not less than 7 years, or not less than 10 years if
						no additional stereotactic breast biopsy procedures of the patient are
						performed at the facility.
(b) Upon
						request by, or on behalf of, a patient, permanently or temporarily transfer the
						original stereotactic breast biopsy images and copies of the patient's reports
						to any of the following:
(i) A medical
						institution.
(ii) A patients
						physician.
(iii) The patient
						directly.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › MEDICAL RECORDS AND STEREOTACTIC BREAST BIOPSY REPORTS › Section R. 333.5683 - Stereotactic breast biopsy image identification

Current through Vol. 24-12, July 15, 2024
Rule 683. A stereotactic breast biopsy image shall have
						  the following information indicated on it in a permanent, legible, and
						  unambiguous manner and placed so as not to obscure anatomic structures:
(a) Name of patient and an additional unique
						patient identifier.
(b) Date of the
						procedure.
(c) Designation of left
						or right breast.
(d) Cassette
						identification, if applicable.
(e)
						Stereotactic breast biopsy unit identification if there is more than 1 unit in
						the facility.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › QUALITY ASSURANCE › Section R. 333.5684 - Quality assurance - general

Current through Vol. 24-12, July 15, 2024
Rule 684. A stereotactic breast biopsy facility shall
						  establish and maintain a quality assurance program to ensure the safety,
						  reliability, clarity, and accuracy of stereotactic breast biopsy services
						  performed at the facility.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › QUALITY ASSURANCE › Section R. 333.5685 - Responsible individuals

Current through Vol. 24-12, July 15, 2024
Rule 685.
Responsibility for the quality assurance program and
						  for each of its elements shall be assigned to the following individuals who are
						  qualified for their assignments:
(a)
						Lead stereotactic breast biopsy physician. The facility shall identify a lead
						stereotactic breast biopsy physician who shall be responsible for ensuring that
						the quality assurance program meets all requirements of
						R
						333.5684 to
						R
						333.5697. No other individual shall be assigned or
						shall retain responsibility for quality assurance tasks unless the lead
						stereotactic breast biopsy physician has determined that the individual is
						qualified to perform the assignment.
(b) Stereotactic breast biopsy physicians.
						All stereotactic breast biopsy physicians conducting stereotactic breast biopsy
						procedures for the facility shall follow the facilitys procedures for
						corrective action when the images they are asked to interpret are of poor
						quality.
(c) Medical physicist. The
						facility shall have the services of a medical physicist available to survey
						stereotactic breast biopsy equipment and oversee the equipment-related quality
						assurance practices of the facility. The medical physicist shall be responsible
						for performing the surveys and stereotactic breast biopsy equipment evaluations
						and providing the facility with the reports described in
						R
						333.5693 and
						R
						333.5694.
(d) Quality control technologist.
						Responsibility for tasks within the quality assurance program not assigned to
						the lead stereotactic breast biopsy physician or the medical physicist shall be
						assigned to a quality control technologist. The tasks are to be performed by
						the quality control technologist, but may be delegated to other qualified
						personnel by the quality control technologist. When other personnel are
						utilized for these tasks, the quality control technologist shall ensure that
						they were completed in compliance with
						R 333.5687.
An obvious
						  error in
						  R
						  325.5685 was corrected at the request of the
						  promulgating agency, pursuant to Section 56 of 1969 PA 306, as amended by 2000
						  PA 262, MCL 24.256. The rule containing the error was published in Michigan
						  Register, 2016 MR 10. The memorandum requesting the correction was published in
						  Michigan Register, 2016 MR 16
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › QUALITY ASSURANCE › Section R. 333.5686 - Quality assurance records

Current through Vol. 24-12, July 15, 2024
Rule 686.
(1)
						The lead stereotactic breast biopsy physician, quality control technologist,
						and medical physicist shall ensure that records concerning the following items
						are properly maintained and updated:
(a)
						Stereotactic breast biopsy techniques and procedures.
(b) Quality control, including monitoring
						data and corrective actions taken.
(c) Safety.
(d) Employee qualifications to meet assigned
						quality assurance tasks.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › QUALITY ASSURANCE › Section R. 333.5687 - Radiologic technologist quality control tests

Current through Vol. 24-12, July 15, 2024
Rule 687. A stereotactic breast biopsy facility shall
						  have a radiologic technologist perform the following quality control tests at
						  the intervals specified in this rule:
(a) A localization accuracy test shall be
						performed daily before the equipment is used on patients. Each of the indicated
						needle tip coordinates shall be within 1 millimeter of the actual preset needle
						tip location.
(b) A phantom image
						evaluation shall be performed at least weekly. The phantom image shall achieve
						at least the minimum score established in R 333.5689.
(c) A hard copy output quality test shall be
						performed at least monthly, if hard copies are produced from digital
						data.
(d) A compression test shall
						be performed at least semiannually. The maximum compression force for the power
						drive mode shall be between 25 pounds and 45 pounds.
(e) A repeat analysis shall be performed at
						least semiannually. If the overall repeat or reject rate exceeds 20% based on
						an image volume of not less than 150 patients, the reason for the change shall
						be determined. A repeat analysis shall be assessed semiannually even if fewer
						than 150 patients are examined during that period.
(f) If stereotactic breast biopsy is
						performed using a screen-film system, the following tests shall be required:
(i) A processor quality control test shall be
						performed at least daily. Film processors used to develop stereotactic breast
						biopsy films shall be adjusted and maintained to meet the technical development
						specifications for the mammography film in use. A processor performance test
						shall be performed at the beginning of each operational day before processing
						any clinical images. The test shall use the mammography film used clinically at
						the facility and shall include an assessment of base plus fog density,
						mid-density, and density difference as follows:
(A) The base plus fog density shall be within
						0.03 of the established operating level.
(B) The mid-density shall be within plus or
						minus 0.15 of the established operating level.
(C) The density difference shall be within
						plus or minus 0.15 of the established operating level.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › QUALITY ASSURANCE › Section R. 333.5688 - Annual medical physicists quality control tests

Current through Vol. 24-12, July 15, 2024
Rule 688. Before the radiation machine is used on
						  patients and at least annually thereafter, a stereotactic breast biopsy
						  facility shall have the medical physicist perform all of the following quality
						  control tests:
(a) Collimation
						assessment that meets either of the following:
(i) For screen-film systems, the x-ray field
						shall be contained within the image receptor on all 3 sides except the chest
						wall edge. The x-ray field shall not extend beyond the chest wall edge of the
						image receptor by more than 2% of the source-image receptor distance.
(ii) For digital image receptors, the x-ray
						field may extend beyond the edge of the image receptor on all 4 sides, but no
						edge of the x-ray field shall extend beyond the image receptor by more than 5
						millimeters on any side. Distances shall be measured in, or referred to, the
						plane of the digital image receptor.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › QUALITY ASSURANCE › Section R. 333.5689 - Phantom image scores

Current through Vol. 24-12, July 15, 2024
Rule 689. A stereotactic breast biopsy phantom image
						  score for the tests required in R 333.5687(b) and R 333.5688(h) shall be not
						  less than the values specified in table 689:
TABLE 689
Image System
Standard Mammography Phantom
Mini Stereotactic Phantom
Fibers
Speck Groups
Masses
Fibers
Speck Groups
Masses
Screen-film
4.0
3.0
3.0
2.0
2.0
2.0
Digital
5.0
4.0
3.5
3.0
3.0
2.5
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › QUALITY ASSURANCE › Section R. 333.5690 - Dosimetry

Current through Vol. 24-12, July 15, 2024
Rule 690. The average glandular dose delivered during a
						  single exposure of a department-approved phantom simulating a standard breast
						  shall not exceed 3.0 milligrays (300 millirads) per exposure. The dose shall be
						  determined with technique factors and conditions used clinically for a standard
						  breast.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › QUALITY ASSURANCE › Section R. 333.5691 - Quality assurance for mobile units

Current through Vol. 24-12, July 15, 2024
Rule 691. A stereotactic breast biopsy facility shall
						  verify that mammography units used to produce interventional mammograms at more
						  than 1 location meet the requirements in R 333.5687 to R 333.5690. At each
						  examination location and before any examinations are conducted, the facility
						  shall verify satisfactory performance of these units by using a test method
						  that establishes the adequacy of the image quality produced by the
						  unit.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › QUALITY ASSURANCE › Section R. 333.5692 - Use of quality assurance test results

Current through Vol. 24-12, July 15, 2024
Rule 692.
(1)
						After completion of tests specified in R 333.5687 to R 333.5691, the facility
						shall compare the test results to the corresponding specified action limits or
						the limits established by the facility to verify the image quality of mobile
						units following a move.
(2) If the
						test results fall outside of the action limits, the source of the problem shall
						be identified and corrective actions shall be taken within the following time
						frames:
(a) Before any further examinations
						are performed or any films are processed using a component of the mammography
						system that failed any of the tests described in R 333.5687(a),(b),(d),(f)(i),
						(f)(iii), (f)(iv); R 333.5688(g) and (h); or R 333.5691.
(b) Within 30 days of the test date for all
						other tests described in R 333.5687 to R 333.5691.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › QUALITY ASSURANCE › Section R. 333.5693 - Medical physicist surveys

Current through Vol. 24-12, July 15, 2024
Rule 693.
(1)
						A stereotactic breast biopsy facility shall annually undergo a survey by a
						medical physicist or by an individual under the direct supervision of a medical
						physicist. The survey shall include, at a minimum, the performance of tests to
						ensure that the facility meets the quality assurance requirements of the annual
						tests described in R 333.5688 and the weekly phantom image quality test as
						provided in R 333.5687(b).
(2) The
						results of all tests conducted by the facility pursuant to R 333.5687 to R
						333.5691 and written documentation of any corrective actions taken and their
						results shall be evaluated for adequacy by the medical physicist performing the
						survey.
(3) The medical physicist
						shall prepare a survey report that includes a summary of this review and
						recommendations for necessary improvements.
(4) The survey report shall be provided to
						the facility within 30 days of the date of the survey.
(5) The survey report shall be dated and
						signed by the medical physicist who performed or supervised the survey. If the
						survey was performed entirely or in part by an individual under the direct
						supervision of the medical physicist, that individual and the part of the
						survey that individual performed shall be identified in the survey
						report.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › QUALITY ASSURANCE › Section R. 333.5694 - Mammography equipment evaluations

Current through Vol. 24-12, July 15, 2024
Rule 694.
(1)
						Additional evaluations of stereotactic breast biopsy units or image processors
						shall be conducted when a new unit or processor is installed, a unit or
						processor is disassembled and reassembled at the same or a new location, or
						major components of a stereotactic breast biopsy unit or processor equipment
						are changed or repaired. These evaluations shall be used to determine whether
						the new or changed equipment meets the requirements of R 333.5676 to R 333.5678
						and R 333.5687 to R 333.5691, as applicable. Problems revealed by the
						evaluation shall be corrected before the new or changed equipment is put into
						service for procedures or film processing.
(2) The equipment evaluations specified in
						subrule (1) of this rule shall be performed by a medical physicist or by an
						individual under the direct supervision of a medical physicist.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › QUALITY ASSURANCE › Section R. 333.5695 - Cleanliness in facilities using screen-film systems

Current through Vol. 24-12, July 15, 2024
Rule 695.
(1)
						A stereotactic breast biopsy facility shall establish and implement protocols
						for maintaining darkroom, screen, and view box cleanliness.
(2) The facility shall document that all
						cleaning procedures are performed at the frequencies specified in the
						protocols.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › QUALITY ASSURANCE › Section R. 333.5696 - Calibration of air kerma measuring instruments

Current through Vol. 24-12, July 15, 2024
Rule 696. Instruments used by a medical physicist in
						  his or her annual survey to measure the air kerma or air kerma rate from a
						  stereotactic breast biopsy unit shall be calibrated once every 2 years and each
						  time the instrument is repaired. The instrument calibration shall be traceable
						  to a national standard and calibrated with an accuracy of plus or minus 6% (95%
						  confidence level) in the mammography energy range.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 14 - MAMMOGRAPHY › QUALITY ASSURANCE › Section R. 333.5697 - Infection control

Current through Vol. 24-12, July 15, 2024
Rule 697. A stereotactic breast biopsy facility shall
						  establish and comply with procedures to be followed for cleaning and
						  disinfecting stereotactic breast biopsy equipment after contact with blood or
						  other potentially infectious materials. The procedures shall include methods
						  for documenting facility compliance with the infection control
						  procedures.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 15 - COMPUTED TOMOGRAPHY INSTALLATIONS › Section R. 333.5701 - Purpose and scope

Current through Vol. 24-12, July 15, 2024
Rule 701.
(1)
					 This part establishes requirements governing the use of computed tomography
					 (CT) scanners by, or on behalf of, a health practitioner licensed under article
					 15 of the act.
(2) This part
					 applies to all registrants who use a CT scanner for the intentional exposure of
					 humans for diagnostic imaging.
(3)
					 A CT scanner is exempt from this part if the scanner meets 1 of the following:
(a) Generates a peak power of 5 kilowatts or
					 less as certified by the manufacturer.
(b) Is used only for attenuation corrections
					 and anatomical markers as part of a positron emission tomography (PET/CT) or
					 single photon emission computed tomography (SPECT/CT) study.
(c) Is used as a simulator solely for
					 treatment planning purposes in conjunction with a megavoltage radiation therapy
					 unit.
(d) Is used solely for
					 intra-operative guidance tomography.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 15 - COMPUTED TOMOGRAPHY INSTALLATIONS › Section R. 333.5703 - Definitions

Current through Vol. 24-12, July 15, 2024
Rule 703.
(1) As
					 used in this part the definitions in
					 21 C.F.R.
					 1020.33, "Computed tomography (CT) equipment"
					 (June 10, 2005), are adopted by reference. Copies of these regulations are
					 available for no cost from either of the following sources:
(a) The website of the Michigan department of
					 licensing and regulatory affairs, radiation safety section at
http://www.michigan.gov/rss
.
(b) The website of the United States
					 department of health & human services, U.S. food and drug administration at
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
.
Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 15 - COMPUTED TOMOGRAPHY INSTALLATIONS › Section R. 333.5705 - CT operators

Current through Vol. 24-12, July 15, 2024
Rule 705. All CT examinations shall be performed by a
						radiologic technologist who meets all of the following requirements or by a
						physician or osteopathic physician licensed under article 15 of the act.
(a) Initial qualifications. Before beginning
					 to perform CT examinations independently, a technologist shall meet both of the
					 following:
(i) Be currently registered by the
					 American registry of radiologic technologists (ARRT), the Canadian association
					 of medical radiation technologists (CAMRT), or the Nuclear Medicine Technology
					 Certification Board (NMTCB).
(ii)
					 Document at least 20 hours of training and experience in operating CT
					 equipment, radiation physics, and radiation protection or have the advanced
					 certification in computed tomography from the ARRT.