reglab/statecodes huggingface dataset:
Illinois Administrative Code › Title 32 - ENERGY › Part 360 - USE OF X-RAYS IN THE HEALING ARTS INCLUDING MEDICAL, DENTAL, PODIATRY, AND VETERINARY MEDICINE › Section 360.75 - Computed Tomography (CT) Systems

Current through Register Vol. 48, No. 28, July 12, 2024
a) Requirements for Equipment
1) Termination of Exposure
A) In the event of equipment failure
			 affecting data collection, means shall be provided to terminate the x-ray
			 exposure automatically, either by de-energizing the x-ray source or by
			 shuttering the x-ray beam, through the use of either a back-up timer or devices
			 that monitor equipment function.
B)
			 A visible signal shall indicate when the x-ray exposure has been terminated
			 through the means required by subsection (a)(1)(A).
C) The operator shall be able to terminate
			 the x-ray exposure at any time during a scan, or series of scans, of greater
			 than 0.5 second duration.
Illinois Administrative Code › Title 32 - ENERGY › Part 360 - USE OF X-RAYS IN THE HEALING ARTS INCLUDING MEDICAL, DENTAL, PODIATRY, AND VETERINARY MEDICINE › Section 360.90 - Dental Radiographic Systems

Current through Register Vol. 48, No. 28, July 12, 2024
In addition to the provisions of Sections
				360.10,
				360.30
				and
				360.40
				of this Part, the requirements of this Section apply to x-ray equipment and
				associated facilities used for dental radiography. Refer to Section
				360.50 of
				this Part for requirements for dental fluoroscopic systems.
a) General Requirements
1) Timers. Means shall be provided to
			 terminate the exposure at a preset time interval, preset product of current and
			 time, preset number of pulses or preset radiation exposure to the image
			 receptor. Also, it shall not be possible to make an exposure when the timer is
			 set to a zero or off position if either position is provided.
2) X-Ray Control. An x-ray control shall be
			 incorporated into each x-ray system such that an exposure can be terminated by
			 the operator at any time except for exposures of 0.5 second or less.
3) Exposure Switch Arrangement. The exposure
			 switch shall be a dead-man switch and shall be arranged so that the operator
			 can be behind a protective barrier or at least 1.83 meters (6 feet) from the
			 patient and the tube housing during an exposure.
Illinois Administrative Code › Title 32 - ENERGY › Part 360 - USE OF X-RAYS IN THE HEALING ARTS INCLUDING MEDICAL, DENTAL, PODIATRY, AND VETERINARY MEDICINE › Section 360.100 - Veterinary Radiographic Systems

Current through Register Vol. 48, No. 28, July 12, 2024
In addition to the provisions of Sections
				360.10,
				360.30
				and
				360.40
				(except Section
				360.40(a)
				) of this Part, the requirements of this Section apply to x-ray equipment and
				associated facilities used for radiography with veterinary systems.
a) Beam Limitation. The useful beam shall be
			 limited to the area of clinical interest. The size of the image receptor used
			 for each radiographic projection shall be consistent with the objectives of the
			 examination.
1) Limitation Criteria. Means
			 shall be provided to limit the x-ray field in the plane of the image receptor
			 so that the field does not exceed each dimension of the image receptor by more
			 than two percent of the SID when the axis of the x-ray beam is perpendicular to
			 the plane of the image receptor.
2)
			 Means shall be provided to align the center of the x-ray field with the center
			 of the image receptor to within two percent of the SID.
3) The requirements of subsection (a)(1) of
			 this Section may be met with:
A) An adjustable
			 collimator with a field defining light; or
B) An assortment of removable,
			 fixed-aperture, beam-limiting devices sufficient to meet the requirement for
			 each combination of image receptor size and SID for which the unit is used,
			 with each such device having permanent, clearly legible markings in centimeters
			 and/or inches, to indicate the image receptor size and SID for which it is
			 designed; or
C) A beam-limiting
			 device having multiple fixed apertures sufficient to meet the requirement for
			 each combination of image receptor size and SID for which the unit is used.
			 Permanent, clearly legible markings, in centimeters and/or inches, shall
			 indicate the image receptor size and SID for which each aperture is designed
			 and shall indicate which aperture is in position for use.
4) SID Indication
A) Means shall be provided to indicate the
			 SID.
B) SIDs shall be indicated in
			 centimeters and/or inches and the measured SID shall correspond to the
			 indicated value to within two percent.
Illinois Administrative Code › Title 32 - ENERGY › Part 360 - USE OF X-RAYS IN THE HEALING ARTS INCLUDING MEDICAL, DENTAL, PODIATRY, AND VETERINARY MEDICINE › Section 360.130 - Electronic Brachytheraphy

Current through Register Vol. 48, No. 28, July 12, 2024
a)
			 Applicability. Electronic brachytherapy devices shall be subject to the
			 requirements of this Section and shall be exempt from the requirements of
			 Section
			 360.110,
			 unless otherwise noted in this Section.
1) An
			 electronic brachytherapy device that does not meet the requirements of this
			 Section shall not be used for irradiation of patients; and
2) An electronic brachytherapy device shall
			 only be utilized for human use applications specifically approved by the U.S.
			 Food and Drug Administration (FDA) unless participating in a research study
			 approved by the registrant's Institutional Review Board.
Illinois Administrative Code › Title 32 - ENERGY › Part 360 - USE OF X-RAYS IN THE HEALING ARTS INCLUDING MEDICAL, DENTAL, PODIATRY, AND VETERINARY MEDICINE › Appendix E - Minimum Quality Control Program for Medical Accelerators

Current through Register Vol. 48, No. 28, July 12, 2024
a) Mechanical tests
1) Patient support assembly motions
2) Gantry angle indicators
3) Optical distance indicator
4) Alignment lights
5) Congruence of radiation beam and light
				field
6) Accuracy of field size indicators
7) Mechanical isocenter - gantry and
				collimator
8) Mechanical interlocks
b) Radiation beam tests
1) Machine operating parameters
2) Dose per monitor unit for x-ray and electron
				beams
3) Dose per degree for moving beam therapy
4) Radiation isocenter
5) Flatness and symmetry
6) Wedge transmission factors
7) Shadow tray transmission factors
8) Energy check on central axis
9) Radiation output versus field size
c) Control panel checks
1) Radiation "ON" condition
2) Indicator lamp check
3) Computer control of accelerator
d) Facility checks
1) Patient audio-visual communication
2) Entrance door interlock
3) Warning lights
4) Emergency off buttons
e) Control Panel
1) Digital displays
2) Analog displays
3) Status displays
4) Interlock displays
5) Reset display
f) Patient Dosimetry Calculations
1) Calculation of patient treatment times
2) Computer calculations of patient treatment
				times
Illinois Administrative Code › Title 32 - ENERGY › Part 360 - USE OF X-RAYS IN THE HEALING ARTS INCLUDING MEDICAL, DENTAL, PODIATRY, AND VETERINARY MEDICINE › Table B - Half-Value Layer as a Function of Tube Potential

Current through Register Vol. 48, No. 28, July 12, 2024
X-ray Tube Voltage (kilovolt peak)
Minimum HVL (mm of
						  Al)1
Designed operating range
Measured Operating Potential
Specified Dental
						  Systems2
Other X-Ray Systems3
Below 50
30
1.5
0.3
40
1.5
0.4
49
1.5
0.5
50 to 70
50
1.5
1.2
60
1.5
1.3
70
1.5
1.5
Above 71
71
2.1
2.1
80
2.3
2.3
90
2.5
2.5
100
2.7
2.7
110
3.0
3.0
120
3.2
3.2
130
3.5
3.5
140
3.8
3.8
150
4.1
4.1
1 Linear extrapolation or
				interpolation may be made for an x-ray tube potential (kVp) not listed in the
				table above (e.g., in the column entitled "Other X-ray Systems" operated at 20
				kVp and 95 kVp, the minimum HVL required would be 0.2 and 2.6 millimeters of
				aluminum respectively).
2 "Specified Dental Systems" means
				any dental x-ray system designed for use with intraoral image receptors and
				manufactured after December 1, 1980.
3 "Other X-Ray Systems" means all
				x-ray systems required to meet the provisions of Sections
				360.50,
				360.60,
				360.75,
				360.90
				(except "Specified Dental Systems") and
				360.100
				of this Part. Half-value layer requirements for mammography systems are
				specified in Section
				360.71(e)
				of this Part.
Illinois Administrative Code › Title 32 - ENERGY › Part 370 - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 370.10 - Scope

Current through Register Vol. 48, No. 28, July 12, 2024
This Part establishes quality standards and certification
				requirements for facilities performing mammography to ensure that all
				mammography facilities are adequately and consistently evaluated for compliance
				with the standards provided in this Part. The provisions of this Part are in
				addition to and not in substitution for other applicable provisions of 32 Ill.
				Adm. Code 310, 320, 340, 400, 401 and 410.
Illinois Administrative Code › Title 32 - ENERGY › Part 370 - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 370.30 - Incorporations by Reference

Current through Register Vol. 48, No. 28, July 12, 2024
All rules, standards and guidelines of agencies of the United
				States or nationally recognized organizations or associations that are
				incorporated by reference in this Part are incorporated as of the date
				specified in the reference and do not include any later amendments or editions.
				Copies of rules, standards and guidelines that have been incorporated by
				reference are available for public inspection and copying at the Illinois
				Emergency Management Agency, 1035 Outer Park Drive, Springfield,
				Illinois.
Illinois Administrative Code › Title 32 - ENERGY › Part 370 - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 370.40 - Exemptions

Current through Register Vol. 48, No. 28, July 12, 2024
a) Mammography
			 units used only during invasive interventions for localization or biopsy
			 procedures are exempt from the requirements of this Part, except that such
			 systems shall satisfy the criteria specified in Section
			 370.170
			 of this Part.
b) Each mobile
			 mammography facility based outside of Illinois that operates in Illinois and
			 that has not been certified by the Agency is exempt from the requirements of
			 Sections
			 370.50
			 and 370.60 of this Part,
			 provided that:
1) The mobile mammography
			 facility is certified to perform mammography by FDA or other FDA-approved
			 certifying agency at all times while conducting operations in Illinois;
			 and
2) The mobile mammography
			 facility meets the requirements of Section
			 370.145
			 of this Part.
Illinois Administrative Code › Title 32 - ENERGY › Part 370 - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 370.50 - Requirements for Certification

Current through Register Vol. 48, No. 28, July 12, 2024
a)
			 Except as otherwise provided in subsection (b)(1)(C) and Section
			 370.40, a certificate
			 issued by the Agency is required for lawful operation of all mammography
			 facilities subject to the provisions of this Part. Facilities performing
			 mammography shall meet the requirements of Sections
			 370.70,
			 370.80,
			 370.90,
			 370.100,
			 370.110,
			 370.120
			 and
			 370.130
			 and be accredited by an FDA-approved accreditation body. Each mammography unit
			 shall be accredited by or have an application pending for accreditation with an
			 FDA-approved accrediting body.
AGENCY NOTE: Currently, the only FDA-approved accrediting body
				in Illinois is the American College of Radiology.
AGENCY NOTE: Except for provisional certificates and interim
				notices, the term of certificates issued under this Section shall be for 3
				years.
b) Application.
1) Certificates.
A) In order to qualify for a certificate, a
			 facility shall apply to an accreditation body.
B) Following the Agency's receipt of the
			 accreditation body's decision to accredit a facility, the Agency may issue a
			 certificate to the facility, or renew an existing certificate, if the Agency
			 determines that the facility has satisfied the requirements for certification
			 or recertification.
C) An interim
			 notice authorizes the facility to perform mammography until the facility
			 receives its certificate but in no case for more than 45 days. No more than one
			 interim notice may be issued to a facility per application for certification.
			 The Agency may issue an interim notice of mammography certification by
			 facsimile to a facility if a delay is anticipated in providing a certificate to
			 the facility under one or more of the following circumstances:
i) The Agency has been notified by an
			 accreditation body that the facility meets the requirements for a provisional
			 or provisional reinstatement certificate and delivery of the certificate may
			 take more than 24 hours;
ii) The
			 Agency has been notified by an accreditation body that the facility has
			 completed accreditation or reaccreditation and delivery of the certificate to
			 the facility may take more than 24 hours; or
iii) The Agency has been notified by an
			 accreditation body that the facility has timely submitted an application for
			 accreditation or reaccreditation but the completion of the accreditation
			 process may extend beyond the expiration date of a facility's existing
			 certificate through no fault of the facility.
Illinois Administrative Code › Title 32 - ENERGY › Part 370 - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 370.60 - Fees

Current through Register Vol. 48, No. 28, July 12, 2024
a) Except as
			 provided in subsection (b), the Agency shall assess each certified mammography
			 installation an annual certification fee of $1,300 in each State fiscal year
			 (July 1-June 30). The Agency shall bill the mammography installation for the
			 annual fee after July 1. The annual fee shall be due and payable within 60 days
			 after the date of billing. Failure to pay the required fee may result in
			 revocation of the certificate.
AGENCY NOTE: The annual fee described in subsection (a) applies
				to both fully and provisionally certified mammography installations.
b) A new mammography installation
			 issued an initial provisional certificate after December 31 of any State fiscal
			 year shall not be required to pay a certification fee for that State fiscal
			 year.
Illinois Administrative Code › Title 32 - ENERGY › Part 370 - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 370.70 - Personnel Requirements

Current through Register Vol. 48, No. 28, July 12, 2024
Personnel. The following requirements apply to all personnel
				involved in any aspect of mammography, including the production, processing,
				and interpretation of mammograms and related quality assurance
				activities:
a) Interpreting
			 physicians. All physicians interpreting mammograms shall meet the following
			 qualifications:
1) Initial qualifications.
			 Unless the exemption in subsection (a)(3) of this Section applies, before
			 beginning to interpret mammograms independently, the interpreting physician
			 shall:
A) Be a physician licensed under the
			 Medical Practice Act of 1987 to practice medicine in all its branches [225 ILCS
			 60 ];
B) Be certified in diagnostic
			 radiology by either the American Board of Radiology, the American Osteopathic
			 Board of Radiology, or Royal College of Physicians and Surgeons of Canada or
			 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 shall be under the direct supervision of a physician
			 who meets the requirements of subsection (a) of this Section;
C) Have a minimum of 60 hours of documented
			 medical education in mammography, which shall include instruction in the
			 interpretation of mammograms and education in basic breast anatomy, pathology,
			 physiology, technical aspects of mammography and quality assurance and quality
			 control in mammography. All 60 of these hours shall be Category I and at least
			 15 of the Category I hours shall have been acquired within the 3 years
			 immediately prior to the date that the physician qualifies as an interpreting
			 physician. Hours spent in residency specifically devoted to mammography will be
			 considered as equivalent to Category I continuing medical education credits and
			 will be accepted if documented in writing by the appropriate representative of
			 the training institution; and
D)
			 Unless the exemption in subsection (a)(3) of this Section applies, have
			 interpreted or multi-read at least 240 mammographic examinations within the 6
			 month period immediately prior to the date that the physician qualifies as an
			 interpreting physician. This interpretation or multi-reading shall be under the
			 direct supervision of an interpreting physician.
Illinois Administrative Code › Title 32 - ENERGY › Part 370 - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 370.80 - Equipment Requirements

Current through Register Vol. 48, No. 28, July 12, 2024
The equipment requirements of this Section are intended to
				ensure that mammography equipment is capable of producing quality mammograms
				over the full range of clinical conditions.
a) Prohibited equipment. Radiographic
			 equipment designed for general purpose shall not be used for mammography.
			 Mammography shall only be performed with a special purpose radiation machine
			 specifically designed for and used solely for mammography procedures.
b) General. All radiographic equipment used
			 for mammography shall be certified under the "Performance Standards for
			 Diagnostic X-Ray Systems and their Major Components", published at
			 21 CFR
			 1020.30, effective as of April 1, 2012. Each
			 radiographic unit used for mammography shall be accredited by an approved
			 accrediting body or have an application for accreditation pending with an
			 approved accrediting body.
c)
			 Motion of tube-image receptor assembly.
1) The
			 assembly shall be capable of being fixed in any position where it is designed
			 to operate. Once fixed in any such position, it shall not undergo unintended
			 motion.
2) The mechanism ensuring
			 compliance with subsection (c)(1) shall not fail in the event of power
			 interruption.
Illinois Administrative Code › Title 32 - ENERGY › Part 370 - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 370.90 - Medical Records and Mammography Reports

Current through Register Vol. 48, No. 28, July 12, 2024
a) Contents and terminology. Each facility
			 shall prepare a written report of the results of each mammography examination
			 performed under its certificate. The mammography report shall include the
			 following information:
1) The name of the
			 patient and an additional patient identifier;
2) Date of examination;
3) The name of the interpreting physician who
			 interpreted the mammogram;
4)
			 Overall final assessment of findings, classified in one of the following
			 categories:
A) "Negative." Nothing to comment
			 upon (if the interpreting physician is aware of clinical findings or symptoms,
			 despite the negative assessment, these shall be explained);
B) "Benign." Also a negative
			 assessment;
C) "Probably Benign."
			 Finding(s) has a high probability of being benign;
D) "Suspicious." Finding(s) without all the
			 characteristic morphology of breast cancer but indicating a definite
			 probability of being malignant;
E)
			 "Highly suggestive of malignancy." Finding(s) has a high probability of being
			 malignant;
5) In cases
			 where no final assessment category can be assigned due to incomplete work-up,
			 "Incomplete: Need additional imaging evaluation" shall be assigned as an
			 assessment and reasons why no assessment can be made shall be stated by the
			 interpreting physician; and
6)
			 Recommendations made to the health care provider about what additional actions,
			 if any, should be taken. All clinical questions raised by the referring health
			 care provider shall be addressed in the report to the extent possible, even if
			 the assessment is negative or benign.
Illinois Administrative Code › Title 32 - ENERGY › Part 370 - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 370.100 - Quality Assurance Requirements

Current through Register Vol. 48, No. 28, July 12, 2024
Each facility shall establish and maintain a quality assurance
				program to ensure the safety, reliability, clarity and accuracy of mammography
				services performed at the facility.
a)
			 Responsible individuals. Responsibility for the quality assurance program and
			 for each of its elements shall be assigned to individuals who are qualified for
			 their assignments and who shall be allowed adequate time to perform these
			 duties.
1) Lead interpreting physician. The
			 facility shall identify a lead interpreting physician who shall have the
			 general responsibility of ensuring that the quality assurance program meets all
			 requirements of this Section and Sections
			 370.110,
			 370.120(b)
			 and (c) and
			 370.130
			 of this Part. No other individual shall be assigned or shall retain
			 responsibility for quality assurance tasks unless the lead interpreting
			 physician has determined that the individual's qualifications for, and
			 performance of, the assignment are adequate.
2) Interpreting physicians. All interpreting
			 physicians interpreting mammograms for the facility shall:
A) Follow the facility procedures for
			 corrective action when the images they are asked to interpret are of poor
			 quality; and
B) Participate in the
			 facility's medical outcomes audit program.
3) Medical physicist. Each facility shall
			 have the services of a medical physicist available to survey mammography
			 equipment and oversee the equipment-related quality assurance practices of the
			 facility. At a minimum, the medical physicist shall be responsible for
			 performing the surveys and mammography equipment evaluations and providing the
			 facility with the reports described in Section
			 370.110(i)
			 of this Part.
4) Quality control
			 technologist. Responsibility for all individual tasks within the quality
			 assurance program not assigned to the lead interpreting physician or the
			 medical physicist shall be assigned to a quality control technologist. The
			 tasks are to be performed by the quality control technologist or by other
			 personnel qualified to perform the tasks. When other personnel are utilized for
			 these tasks, the quality control technologist shall ensure that the tasks are
			 completed in such a way as to meet the requirements of Section
			 370.110
			 of this Part.
Illinois Administrative Code › Title 32 - ENERGY › Part 370 - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 370.110 - Equipment Quality Assurance Tests

Current through Register Vol. 48, No. 28, July 12, 2024
a) Daily quality control tests. Film
			 processors used to develop mammograms shall be adjusted and maintained to meet
			 the technical development specifications for the mammography film in use. A
			 processor performance test shall be performed on each day that examinations are
			 performed before any clinical films are processed that day. The test shall
			 include an assessment of base plus fog density, mid-density and density
			 difference, using the mammography film used clinically at the facility.
1) The base plus fog density shall be within
			 plus 0.03 of the established operating level.
2) The mid-density shall be within plus or
			 minus 0.15 of the established operating level.
3) The density difference shall be within
			 plus or minus 0.15 of the established operating level.
Illinois Administrative Code › Title 32 - ENERGY › Part 370 - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 370.120 - Additional Administrative Requirements

Current through Register Vol. 48, No. 28, July 12, 2024
a) Every operator of a radiation installation
			 at which mammography services are provided shall ensure and have confirmed by
			 each mammography patient that the patient is provided with a pamphlet that is
			 orally reviewed with the patient and that contains the following:
1) How to perform breast
			 self-examination;
2) That early
			 detection of breast cancer is maximized through a combined approach, using
			 monthly breast self-examination, a thorough physical examination performed by a
			 physician, and mammography performed at recommended intervals;
3) That mammography is the most accurate
			 method for making an early detection of breast cancer, however, no diagnostic
			 tool is 100% effective;
4) If the
			 patient is self-referred and does not have a primary care physician, or if the
			 patient is unfamiliar with the breast examination procedures, that the patient
			 has received information regarding public health services where she can obtain
			 a breast examination and instructions. [420
			 ILCS 40/5(c) ]
Illinois Administrative Code › Title 32 - ENERGY › Part 370 - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 370.130 - Mammography Medical Outcomes Audit

Current through Register Vol. 48, No. 28, July 12, 2024
Each facility shall establish and maintain a mammography
				medical outcomes audit program to follow up positive mammographic assessments
				and to correlate pathology results with the interpreting physician's findings.
				This program shall be designed to ensure the reliability, clarity and accuracy
				of the interpretation of mammograms.
a) General requirements. Each facility shall
			 establish a system to collect and review outcome data for all mammograms
			 performed, including followup on the disposition of all positive mammograms and
			 correlation of pathology results with the interpreting physician's mammography
			 report. Analysis of these outcome data shall be made individually and
			 collectively for all interpreting physicians at the facility. In addition, any
			 cases of breast cancer among patients imaged at the facility that subsequently
			 become known to the facility shall prompt the facility to initiate followup on
			 surgical and/or pathology results and review of the mammograms taken prior to
			 the diagnosis of a malignancy.
b)
			 Frequency of audit analysis. The facility's first audit analysis shall be
			 initiated no later than 12 months after the date the facility becomes
			 certified. This audit analysis shall be completed within an additional 12
			 months to permit completion of diagnostic procedures and data collection.
			 Subsequent audit analyses will be conducted at least once every 12
			 months.
c) Audit interpreting
			 physician. Each facility shall designate at least one interpreting physician to
			 review the medical outcomes audit data at least once every 12 months. This
			 individual shall record the dates of the audit periods and shall be responsible
			 for analyzing results based on this audit. This individual shall also be
			 responsible for documenting the results, notifying other interpreting
			 physicians of their results and the facility aggregate results. If followup
			 actions are taken, the audit interpreting physician shall also be responsible
			 for documenting the nature of the followup.
Illinois Administrative Code › Title 32 - ENERGY › Part 370 - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 370.140 - Additional Mammography Review and Patient Notification

Current through Register Vol. 48, No. 28, July 12, 2024
a) If the Agency believes that mammography
			 quality at a facility has been compromised and may present a serious risk to
			 human health, the facility shall provide clinical images and other relevant
			 information, as specified by the Agency, for review by the accreditation body.
			 This additional mammography review will help the Agency to determine whether
			 the facility is in compliance with this Part and, if not, whether there is a
			 need to notify affected patients, their physicians or the public that the
			 reliability, clarity and accuracy of interpretation of mammograms has been
			 compromised.
b) If the Agency
			 determines that the quality of mammography performed by a facility, whether or
			 not certified under Section
			 370.50
			 of this Part, was so inconsistent with the quality standards established in
			 this Part as to present a significant risk to individual or public health, the
			 Agency may require the facility to notify patients who received mammograms at
			 the facility, and their referring physicians, of the deficiencies presenting
			 the risk, the potential harm resulting, appropriate remedial measures and other
			 relevant information as the Agency may require.
Illinois Administrative Code › Title 32 - ENERGY › Part 370 - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 370.145 - Notification Requirements for Mobile Mammography Facilities Certified by Another Certifying Entity

Current through Register Vol. 48, No. 28, July 12, 2024
Mobile mammography facilities that operate in Illinois and are
				certified under MQSA by the FDA, or another state authorized by FDA to certify
				mammography facilities under MQSA, shall:
a) Notify the Agency by telephone, facsimile
			 or letter of each date and location of operation of the mobile mammography
			 facility in Illinois prior to conducting such operation.
AGENCY NOTE: Notifications submitted by the mobile mammography
				facility to the Agency may contain notice of multiple dates and locations of
				operation by the mobile mammography facility.
b) At all times while operating in Illinois,
			 have the following documentation available for review and inspection by the
			 Agency:
1) A copy of the mammography facility
			 certificate issued by the FDA or another state, showing that the facility is
			 currently certified.
2) A summary
			 of the most recent physics survey of the mammography machine and documentation
			 of any corrective actions recommended by the medical physicist who performed
			 the physics survey.
3)
			 Documentation that personnel meet the qualifications of Section
			 370.70 of
			 this Part.
Illinois Administrative Code › Title 32 - ENERGY › Part 370 - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 370.150 - Revocation of Accreditation and Revocation of Accreditation Body Approval

Current through Register Vol. 48, No. 28, July 12, 2024
If a facility's accreditation is revoked by an accreditation
				body, the Agency may conduct an investigation into the reasons for the
				revocation. Following the investigation, the Agency may act to suspend or
				revoke the facility's certificate and may take whatever other action or
				combination of actions will best protect the public health, including requiring
				the establishment and implementation of a corrective plan of action that will
				permit the certificate to continue in effect while the facility seeks
				reaccreditation. A facility whose certificate is suspended or revoked because
				it has lost its accreditation may not practice mammography.
Illinois Administrative Code › Title 32 - ENERGY › Part 370 - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 370.160 - Suspension, Revocation or Denial of Certificates

Current through Register Vol. 48, No. 28, July 12, 2024
a) The Agency may suspend, revoke or deny a
			 certificate if the Agency finds that the owner, operator or any employee of the
			 facility:
1) Has been guilty of
			 misrepresentation in obtaining the certificate;
2) Has failed to comply with the standards of
			 Sections
			 370.70,
			 370.80,
			 370.90,
			 370.100,
			 370.110,
			 370.120
			 and
			 370.130
			 of this Part;
3) Has failed to
			 comply with reasonable requests of the Agency or the accreditation body for
			 records, information, reports, or materials that the Agency believes are
			 necessary to determine the continued eligibility of the facility for a
			 certificate or continued compliance with the standards of Sections 370.70,
			 370.80, 370.90, 370.100, 370.110, 370.120, 370.130 and 370.140 of this
			 Part;
4) Has refused a reasonable
			 request of a duly designated FDA inspector, Agency inspector, or accreditation
			 body representative for permission to inspect the facility or the operations
			 and pertinent records of the facility;
5) Has violated or aided and abetted in the
			 violation of any provision of this Part;
6) Has failed to comply with prior sanctions
			 imposed by the Agency; and
7) Has
			 failed to pay any required fees.
Illinois Administrative Code › Title 32 - ENERGY › Part 370 - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 370.165 - Failure of Mobile Mammography Facilities Certified by Another Certifying Entity to Meet Requirements

Current through Register Vol. 48, No. 28, July 12, 2024
If the Agency has reason to believe that the owner, operator or
				any employee of a mobile mammography facility certified by another certifying
				entity:
a) has been guilty of
			 misrepresentation in obtaining the certificate;
b) has failed to comply with the standards of
			 Sections
			 370.70,
			 370.80,
			 370.90,
			 370.100,
			 370.110,
			 370.120
			 or
			 370.130
			 of this Part;
c) has failed to
			 comply with reasonable requests of the Agency for records, information,
			 reports, or materials that the Agency believes are necessary to determine the
			 continued eligibility of the facility for a certificate or continued compliance
			 with the standards of Sections 370.70, 370.80, 370.90, 370.100, 370.110,
			 370.120, 370.130 or 370.140 of this Part; or
d) has refused a reasonable request of a
			 Agency representative for permission to inspect the facility or the operations
			 and pertinent records of the facility;
the Agency shall notify the certifying entity of the facts and
				circumstances and may take other actions as may be appropriate under Sections
				36, 38 or 40 of the Radiation Protection Act of 1990 [420 ILCS 40/36, 38, and
				40 ].
Illinois Administrative Code › Title 32 - ENERGY › Part 370 - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 370.170 - Mammography Units Used for Localization or Biopsy Procedures

Current through Register Vol. 48, No. 28, July 12, 2024
a) Personnel. The
			 following requirements apply to all personnel involved in localization or
			 biopsy procedures performed with mammography units:
1) The mammography unit shall be operated by
			 or under the direction of a physician licensed under the Medical Practice Act
			 of 1987 [225 ILCS 60 ].
2)
			 Radiologic technologists operating mammography units for localization or biopsy
			 procedures shall meet the general requirements, mammography requirements and
			 continuing education and experience requirements as specified in Section
			 370.70(b)
			 of this Part.
3) Medical physicists
			 who perform and provide oversight of quality assurance programs for mammography
			 units used for biopsy procedures shall meet the requirements of Section
			 370.70(c)
			 of this Part.
Illinois Administrative Code › Title 32 - ENERGY › Part 370 - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Table A - Mammography Dose Evaluation Table

Current through Register Vol. 48, No. 28, July 12, 2024
This Table is used to determine the mean glandular dose in
				milligrays delivered by 25.8 mC/kg (or millirad) delivered by 1 R in air
				incident on a 4.2 centimeter thickness compressed breast of average density (50
				percent adipose and 50 percent glandular tissue). Values listed are for the
				first half-value layer (HVL) in millimeters of aluminum (mm Al), for x-ray tube
				target-filter combinations of molybdenum/molybdenum (Mo/Mo) and tungsten/
				aluminum (W/Al). Linear extrapolation or interpolation shall be made for any
				HVL not listed.
Mean Glandular Dose in milligrays for 25.8 mC/kg (or millirad
				for 1 R) Entrance Exposure for a 4.2 Centimeter Compressed Breast of Average
				Density
HVL(mm AL)
Mo/Mo Target-Filter X-Ray Tube Voltage (kVp)
W-A1 Target-Filter Combination
23
24
25
26
27
28
29
30
31
32
33
0.23
116
0.24
121
124
0.25
126
129
131
0.26
130
133
135
138
0.27
135
138
140
142
143
0.28
140
142
144
146
147
149
0.29
144
146
148
150
151
153
154
0.30
149
151
153
155
156
157
158
159
170
0.31
154
156
157
159
160
161
162
163
164
175
0.32
158
160
162
163
164
166
167
168
168
170
171
180
0.33
163
165
166
168
169
170
171
173
173
174
175
185
0.34
168
170
171
172
173
174
175
176
177
178
179
190
0.35
174
175
176
177
178
179
180
181
182
183
194
0.36
179
181
182
183
184
185
185
186
187
199
0.37
185
186
187
188
189
190
191
191
204
0.38
190
191
192
193
194
195
195
208
0.39
196
197
198
198
199
200
213
0.40
201
202
203
204
204
217
0.41
206
207
208
208
221
0.42
211
212
212
225
0.43
215
216
230
0.44
220
234
0.45
238
AGENCY NOTE: Adapted from: Mammography Quality Control
				  Manual: Medical Physicist's Section, Revised Edition,
				  1999.
Illinois Administrative Code › Title 32 - ENERGY › Part 380 - ANALYTICAL TYPES OF X-RAY EQUIPMENT › Section 380.10 - Scope

Current through Register Vol. 48, No. 28, July 12, 2024
This Part establishes special requirements for x-ray
				diffraction units, x-ray spectrographic fluorescence equipment, etc. The
				provisions of this Part are in addition to, and not in substitution for, other
				applicable provisions of Agency regulations.
Illinois Administrative Code › Title 32 - ENERGY › Part 380 - ANALYTICAL TYPES OF X-RAY EQUIPMENT › Section 380.20 - Definition

Current through Register Vol. 48, No. 28, July 12, 2024
"Analytical x-ray machines or equipment" means any machine
				utilizing x-rays for examination of the microscopic structure, or elemental or
				chemical composition of materials. This includes all types of x-ray diffraction
				and spectrographic equipment.
Illinois Administrative Code › Title 32 - ENERGY › Part 380 - ANALYTICAL TYPES OF X-RAY EQUIPMENT › Section 380.30 - Labeling

Current through Register Vol. 48, No. 28, July 12, 2024
a) A label bearing
			 the words "Caution - Radiation - This Equipment Produces Radiation When
			 Energized" shall be placed near any switch which energizes a tube.
b) A sign bearing the words "Caution - High
			 Intensity X-Ray Beam", or words having a similar intent, shall be placed in the
			 area immediately adjacent to each tube head. The sign shall be so located that
			 it is clearly visible to any person operating, aligning, or adjusting the unit,
			 or handling or changing a sample.
c) A clearly visible indication of the
			 presence of an x-ray beam shall be provided on or immediately adjacent to each
			 tube head.
d) A clearly visible
			 indication of the status (i.e., open or closed) of each shutter shall be
			 provided.
Illinois Administrative Code › Title 32 - ENERGY › Part 380 - ANALYTICAL TYPES OF X-RAY EQUIPMENT › Section 380.40 - Radiation Exposure Standards

Current through Register Vol. 48, No. 28, July 12, 2024
Radiation exposure to individuals, either within the control
				area or in the environs of the installation, shall be so controlled that the
				maximum permissible dose equivalent values, as set forth in 32 Ill. Adm. Code
				340, are not exceeded.
Illinois Administrative Code › Title 32 - ENERGY › Part 380 - ANALYTICAL TYPES OF X-RAY EQUIPMENT › Section 380.50 - Tests and Inspections

Current through Register Vol. 48, No. 28, July 12, 2024
a) Tests
			 and inspections of all safety devices shall be performed at least monthly to
			 insure their proper operation.
b)
			 Surveys and monitoring sufficient to insure that operations are conducted
			 safely shall be provided.
c)
			 Records of tests and inspections, surveys, and monitoring sufficient to show
			 compliance with Agency regulations shall be maintained and kept available for
			 inspection by a representative of the Agency, upon demand.
Illinois Administrative Code › Title 32 - ENERGY › Part 380 - ANALYTICAL TYPES OF X-RAY EQUIPMENT › Section 380.60 - Operating Procedures and Instructions

Current through Register Vol. 48, No. 28, July 12, 2024
a) Individuals having access to analytical
			 x-ray machines or equipment shall be provided with specific written
			 instructions concerning the radiation hazards, safe working practices, and made
			 aware of the symptoms of an acute localized exposure to radiation. These
			 instructions shall be posted near the controls of the x-ray machine.
b) Medical personnel examining work-connected
			 injuries shall be informed of the possibility of radiation exposure to the
			 worker from the devices regulated in this Part.
c) Operators shall be instructed in the
			 procedures for reporting an actual or suspected radiation overexposure. When it
			 has been determined that an overexposure to an individual has occurred, it
			 shall be reported to the Agency without undue delay.
d) In cases where the primary x-ray beam is
			 not intercepted by the experimental apparatus under all conditions of
			 operation, protective measures shall be provided, such as auxiliary shielding,
			 to avoid exposure to the primary x-ray beam.
e) If, for any reason, it is necessary to
			 temporarily intentionally alter safety devices, such as bypassing interlocks or
			 removing shielding, such action shall be:
1)
			 specified in writing and posted near the x-ray tube housing so that other
			 persons will know the existing status of the machine; and
2) terminated as soon as possible.
Illinois Administrative Code › Title 32 - ENERGY › Part 380 - ANALYTICAL TYPES OF X-RAY EQUIPMENT › Section 380.70 - Monitoring

Current through Register Vol. 48, No. 28, July 12, 2024
Operators of analytical x-ray equipment shall be provided with
				finger or wrist radiation monitoring devices as required by 32 Ill. Adm. Code
				340.520.
Illinois Administrative Code › Title 32 - ENERGY › Part 390 - PARTICLE ACCELERATORS › Section 390.10 - Scope

Current through Register Vol. 48, No. 28, July 12, 2024
Except as otherwise specifically provided, this Part applies to
				all persons who develop, manufacture, receive, possess, use, own or acquire
				accelerators. These provisions are in addition to, and not in substitution for,
				other applicable provisions of Agency regulations. See 32 Ill. Adm. Code 360
				for applicable regulations concerning particle accelerators for medical
				therapeutic applications.
Illinois Administrative Code › Title 32 - ENERGY › Part 390 - PARTICLE ACCELERATORS › Section 390.20 - Definitions

Current through Register Vol. 48, No. 28, July 12, 2024
As used in this Part:
"Accelerator facility" means the location at which one or more
				particle accelerators are installed within one building or under one roof and
				are operated under the same administrative control.
"Particle accelerator" means any device other than an x-ray
				machine that emits ionizing radiation as a result of the acceleration of
				charged particles. Examples are cyclotrons, betatrons, electron linear
				accelerators and potential drop accelerators.
"Qualified expert" means an individual who has demonstrated to
				the satisfaction of the Agency that he or she possesses the knowledge and
				training to measure ionizing radiation, to evaluate safety techniques and to
				advise regarding radiation protection needs. Satisfactory demonstration of
				knowledge and training should include certification by a nationally recognized
				credentialing entity in the field of radiation protection.
Illinois Administrative Code › Title 32 - ENERGY › Part 390 - PARTICLE ACCELERATORS › Section 390.30 - Operating Procedures and Instructions

Current through Register Vol. 48, No. 28, July 12, 2024
a) Each registrant shall inform individuals
			 working in or frequenting any portion of a restricted area as to the presence
			 of radiation or particle accelerators; instruct those individuals in safety
			 problems associated with those areas and in precautions or procedures to
			 minimize radiation exposure; instruct the individuals in the provisions of
			 Agency regulations for the protection of personnel from exposures to radiation;
			 and advise the individuals of reports of radiation exposure that those
			 individuals may request pursuant to this Part.
b) Each particle accelerator facility shall
			 be under the administrative control of a radiation protection officer or
			 radiation safety committee that will be responsible for the safe operation of
			 the accelerator.
c) Written
			 operating and emergency procedures, as well as specified safety rules, shall be
			 established for each accelerator facility and approved by the radiation
			 protection officer.
d) Personnel
			 who operate or maintain particle accelerators shall be familiar with, and have
			 available a copy of, the written operating and emergency procedures.
e) No individual shall be permitted to
			 operate or maintain an accelerator until the individual has received at least
			 the training specified in Section
			 390.70.
f) Modification, repairs or preventive
			 maintenance on accelerator components or safety interlocks may be performed
			 only by or under the direct supervision of individuals who have received at
			 least the training specified in Section 390.70.
g) Provisions shall be made at each
			 accelerator control console to display the name of the individual who is
			 authorized to operate the accelerator. Only the individual whose name is
			 displayed may turn on the accelerator or open entrances to high radiation
			 areas.
h) The radiation safety
			 officer shall maintain a current list of all personnel who are qualified to
			 operate or service the particle accelerator.
i) No registrant shall permit a particle
			 accelerator to operate at any time with a safety interlock bypassed, except for
			 necessary testing. Upon circumvention of an interlock, the registrant shall
			 maintain records showing the date and reasons for bypassing the interlock. A
			 sign shall be posted at the personnel entrance door being bypassed and this
			 condition terminated as soon as possible.
j) Additional Requirements. The Agency may,
			 by rule, regulation or order, impose upon any registrant requirements in
			 addition to those established in this Part as it deems appropriate or necessary
			 to minimize danger to public health and safety or property.