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REVISOR
1.1
Minnesota Department of Health
1.2
Proposed Permanent Rules Relating to Radiation Therapy
RD3888
RADIATION THERAPY
1.3
1.4
SGS/IL
4733.0100 PURPOSE AND SCOPE.
Subpart 1. Purpose. The purpose of this chapter is to control and prevent hazards
1.6
to health and safety from the use of machine-produced radiation therapy and simulation
1.7
equipment for human and nonhuman use without limiting or interfering with its therapeutic
1.8
uses. This chapter does not include the therapy equipment that uses radioactive material
1.9
as found in chapter 4731 or the use of diagnostic or industrial x-ray equipment found in
1.10
chapter 4732.
Subp. 2. Scope. This chapter establishes the requirements, for which the registrant is
AF
1.11
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1.5
1.12
responsible, for using machine-produced radiation therapy and simulation equipment.
1.13
4733.0105 DEFINITIONS.
1.15
1.16
Subpart 1. Scope. For purposes of this chapter, the terms in this part have the
DR
1.14
meanings given them.
Subp. 2. Absorbed dose (D). "Absorbed dose (D)" means the energy imparted by
1.17
ionizing radiation per unit mass of irradiated material. The unit of absorbed dose is the rad
1.18
under the conventional system and the gray (Gy) under the SI system.
1.19
Subp. 3. Absorbed dose rate. "Absorbed dose rate" means absorbed dose per unit
1.20
time for machines with timers, or dose monitor unit per unit time for linear accelerators.
1.21
Subp. 4. Accelerator. "Accelerator" means any machine capable of accelerating
1.22
electrons, protons, deuterons, or other charged particles in a vacuum that discharges the
1.23
resulting particulate or other radiation into a medium at energies usually in excess of one
1.24
MeV. For purposes of this definition, bent beam linear accelerators, external beam linear
1.25
accelerators, linear accelerators, particle accelerators, helical tomotherapy systems, and
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REVISOR
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2.1
linear accelerator-based robotic or nonrobotic stereotactic radiosurgery radiation therapy
2.2
units are included.
2.3
Subp. 5. Air kerma (K). "Air kerma (K)" means the kinetic energy released in
2.4
matter by ionizing radiation. Air kerma is determined as the quotient of dE by dM, where
2.5
dE is the sum of the initial kinetic energies of all the charged ionizing particles liberated
2.6
by uncharged ionizing particles in matter of mass dM. The unit of kerma is the gray (Gy).
2.7
2.8
2.9
Subp. 6. Beam axis. "Beam axis" means the axis of rotation of the beam-limiting
device for therapy systems.
Subp. 7. Beam-limiting device. "Beam-limiting device" means a field-defining
collimator integral to the therapeutic radiation machine and capable of restricting the
2.11
useful beam's dimensions.
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2.10
Subp. 8. Beam-monitoring system. "Beam-monitoring system" means a system
2.13
designed and installed in the radiation head to detect and measure the radiation present
2.14
in the useful beam.
2.15
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2.12
Subp. 9. Contact therapy system. "Contact therapy system" means a
2.16
radiation-therapy machine with a short target-skin distance (TSD), usually less than five
2.17
centimeters.
2.18
2.19
2.20
2.21
2.22
2.23
2.24
2.25
Subp. 10. Dose monitor unit. "Dose monitor unit" means a unit response from the
beam-monitoring system used for calculating the absorbed radiation dose.
Subp. 11. Electronic brachytherapy. "Electronic brachytherapy" means a method
of radiation therapy using electrically generated x-rays to deliver a radiation dose:
A. at a distance of up to a few centimeters by intracavitary, intraluminal, or
interstitial application; or
B. by applications with the source in contact with the body surface or very
close to the body surface.
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REVISOR
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3.1
Subp. 12. Field-flattening filter. "Field-flattening filter" means a filter used to
3.2
homogenize the absorbed dose rate over the radiation field. For purposes of this definition,
3.3
beam-scattering filter or foil are included.
3.4
Subp. 13. Filter. "Filter" means material placed in the useful beam to change beam
3.5
quality in radiation therapy systems. A filter, exclusive of inherent filtration, could be
3.6
removed from the useful beam through any electronic, mechanical, or physical process.
3.7
Subp. 14. Gantry. "Gantry" means that part of the radiation therapy system
3.9
supporting and allowing movement of the radiation head.
Subp. 15. Gray or Gy. "Gray" or "Gy" means the SI unit of absorbed dose, kerma,
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3.8
and specific energy imparted to matter equal to one joule per kilogram. The conventional
3.11
system equivalent is 100 rad.
3.12
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3.10
Subp. 16. High-radiation area. "High-radiation area" means any area, accessible to
individuals, in which radiation levels from radiation sources external to the body could
3.14
result in an individual receiving a radiation dose equivalent in excess of 0.1 rem (1 mSv)
3.15
in one hour at 30 centimeters from any source of radiation or 30 centimeters from any
3.16
surface that the radiation penetrates.
3.17
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3.13
Subp. 17. Intensity-modulated radiation therapy or IMRT. "Intensity-modulated
3.18
radiation therapy" or "IMRT" means a process that enables a more precise conformal
3.19
radiation dose to be distributed to the target area by allowing control of the radiation-beam
3.20
intensity within a given area.
3.21
3.22
3.23
3.24
Subp. 18. Interlock. "Interlock" means a device preventing the start or continued
operation of equipment unless certain predetermined conditions prevail.
Subp. 19. Irradiation. "Irradiation" means the exposure of matter or a living being
to ionizing radiation.
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4.2
REVISOR
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Subp. 20. Isocenter. "Isocenter" means the center of the sphere through which the
useful beam axis passes while the gantry moves through its full range of motions.
4.3
Subp. 21. Kilovolt (kV) or kilo electron volt (keV). "Kilovolt (kV)" or "kilo
4.4
electron volt (keV)" means the energy equal to that acquired by a particle with one
4.5
electron charge in passing through a potential difference of 1,000 volts in a vacuum.
4.6
Current convention is to use kV for photons and keV for electrons.
4.7
4.8
4.9
Subp. 22. Leakage radiation. "Leakage radiation" means radiation emanating from
the diagnostic or therapeutic source assembly except for the useful beam.
Subp. 23. Licensed practitioner of the healing arts. "Licensed practitioner of the
healing arts" means health professionals for diagnostic or healing treatment of human and
4.11
animal maladies, who are licensed under Minnesota Statutes, chapter 147 or 156, for the
4.12
lawful practice of medicine or veterinary medicine.
4.15
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4.14
Subp. 24. Light field. "Light field" means the area illuminated by light that simulates
the radiation field.
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4.13
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4.10
Subp. 25. Medical event. "Medical event" means any event for human use, except
4.16
for an event that results from patient intervention, in which the therapeutic administration
4.17
of radiation results in:
4.18
A. the wrong individual or wrong treatment site;
4.19
B. treatment with the wrong treatment modality or energy;
4.20
C. a dose to tissue other than the treatment site that is 50 percent or more of the
4.21
4.22
4.23
4.24
4.25
dose expected from the administration defined in the written order;
D. a fractionated radiation dose delivered that differs from the prescribed dose,
for a single fraction, by 50 percent or more; or
E. a total radiation dose delivered that differs from the prescribed dose by
20 percent or more.
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5.1
Subp. 26. Megavolt (MV) or mega electron volt (MeV). "Megavolt (MV)" or
5.2
"mega electron volt (MeV)" means the energy equal to that acquired by a particle with one
5.3
electron charge in passing through a potential difference of 1,000,000 volts in a vacuum.
5.4
Current convention is to use MV for photons and MeV for electrons.
5.5
Subp. 27. Mobile electronic brachytherapy service. "Mobile electronic
5.6
brachytherapy service" means transportation of an electronic brachytherapy device to
5.7
provide electronic brachytherapy at an address that is not the address of record.
5.8
Subp. 28. Moving beam radiation therapy. "Moving beam radiation therapy"
means radiation therapy with relative movement of the useful beam or the patient during
5.10
irradiation. Examples include arc, skip, conformal, intensity modulation, and rotational
5.11
therapy.
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5.12
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5.9
Subp. 29. Nominal treatment distance. "Nominal treatment distance" means:
A. for electron irradiation, distance from the scattering foil, virtual source, or
5.14
exit window of the useful beam to the entrance surface of the irradiated object along the
5.15
central access of the useful beam;
5.16
5.17
5.18
5.19
5.20
5.21
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5.13
B. for x-ray irradiation, the virtual source or target to isocenter distance along
the central axis of the useful beam; and
C. for non-isocentric equipment, the distance specified by the manufacturer.
Subp. 30. Patient. "Patient" means an individual or veterinary practice animal
subjected to machine-produced beam radiation for the purposes of therapy.
Subp. 31. Physician assistant. "Physician assistant" means a person licensed under
5.22
Minnesota Statutes, chapter 147A, who is qualified by academic training, practical training,
5.23
or both to provide patient services in radiation therapy according to the physician-physician
5.24
assistant agreement authorized under Minnesota Statutes, section 147A.20.
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6.1
6.2
6.3
REVISOR
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Subp. 32. Protective barrier. "Protective barrier" means the material, excluding
filters, placed in the useful beam to reduce radiation levels for protection purposes.
Subp. 33. Qualified medical physicist. "Qualified medical physicist" means an
6.4
individual qualified to practice independently in the subfields for therapeutic radiological
6.5
physics who:
6.8
6.9
6.10
6.11
6.12
American Board of Radiology;
B. is certified in therapeutic radiological physics by the American Board
of Medical Physics;
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6.7
A. is certified in radiological physics or therapeutic radiological physics by the
C. is certified in therapeutic radiological physics by the Canadian College
of Medical Physics;
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6.6
D. holds a master's degree or doctor's degree in medical physics, radiological
sciences, or an equivalent field involving graduate study in physics applied to the
6.14
application of radiation to humans or veterinary practice animals from an accredited
6.15
college or university and has at least one year of full-time practical training and
6.16
experience involving work in a radiation therapy facility under an individual who meets
6.17
the qualifications in item A, B, or C; or
6.18
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6.13
E. holds a bachelor of science degree in radiological sciences, or an equivalent
6.19
field involving further study in physics applied to the application of radiation to humans or
6.20
veterinary practice animals from an accredited college or university and has at least ten
6.21
years of full-time practical training and experience involving work in a radiation therapy
6.22
facility under an individual who meets the qualifications in item A, B, or C, through a
6.23
written attestation.
6.24
6.25
Subp. 34. Radiation area. "Radiation area" means an area accessible to individuals
where radiation levels could result in an individual receiving a dose equivalent in excess
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REVISOR
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7.1
of 0.005 rem (0.05 mSv) in one hour at 30 centimeters from the source of radiation or
7.2
from any surface that the radiation penetrates.
7.3
Subp. 35. Radiation detector. "Radiation detector" means a device that detects the
7.4
presence of ionizing radiation. The detector must measure the type of radiation being
7.5
measured. Some radiation detectors also identify the characteristics of the radiation.
7.6
7.7
7.8
Subp. 36. Radiation head. "Radiation head" means the structure from which the
useful beam emerges.
Subp. 37. Radiation therapist or radiation therapy technologist. "Radiation
therapist" or "radiation therapy technologist" means a person, other than a licensed
7.10
practitioner of the healing arts, who:
A. performs procedures and applies ionizing radiation emitted from x-ray
AF
7.11
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7.9
7.12
machines or accelerators to human beings or animals for therapeutic purposes while under
7.13
the general supervision of a licensed practitioner of the healing arts;
B. is a member of the radiation oncology team who sees the patient on the
DR
7.14
7.15
treatment day and is responsible for delivering treatment and reviewing the patient's
7.16
tolerance to treatment; and
7.17
C. prior to the effective date of this chapter, has satisfactorily completed a
7.18
nationally recognized examination in radiography or radiation therapy and maintains
7.19
the registration of the examining organization. Nationally recognized examinations are
7.20
provided by the American Registry of Radiologic Technologists for either radiography
7.21
ARRT (R) or therapy ARRT (T); or
7.22
D. following the effective date of this chapter, has satisfactorily completed a
7.23
radiation therapy technologist training program that complies with the requirements of
7.24
the Joint Review Committee on Education in Radiologic Technology or is a registered
7.25
American Registry of Radiologic Technologists ARRT (T).
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8.1
REVISOR
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RD3888
Subp. 38. Radiation therapy system. "Radiation therapy system" means x-ray,
8.2
electron, proton, deuteron, or other charged particles created or accelerated in a vacuum
8.3
designed and used for radiation therapy. This includes electronic brachytherapy.
8.4
Subp. 39. Registrant. "Registrant" means a person having administrative control of
8.5
any radiation therapy system or therapy simulation system and who is legally obligated to
8.6
register with the commissioner according to this chapter.
Subp. 40. Scattered radiation. "Scattered radiation" means radiation that, during
8.8
its passage through a substance, has been changed in direction and may also have been
8.9
modified by a decrease in energy.
Subp. 41. Shutter. "Shutter" means a device attached to the tube housing assembly
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8.10
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8.7
8.11
that can totally intercept the useful beam and has a lead equivalency not less than the
8.12
tube housing assembly.
8.14
Subp. 42. Sievert (Sv). "Sievert (Sv)" means the international system of units (SI)
DR
8.13
dose equivalent. The conventional system of dose equivalent is 100 rem.
8.15
Subp. 43. Stereotactic body radiation therapy or SBRT. "Stereotactic body
8.16
radiation therapy" or "SBRT" means a specialized form of radiation therapy of the body,
8.17
other than intracranial or spinal lesions, which uses a known three-dimensional reference
8.18
system to localize and deliver high doses of radiation to a target lesion with high precision
8.19
in large fraction sizes over a short course, which is typically five or fewer fractions, of
8.20
treatment.
8.21
Subp. 44. Stereotactic radiosurgery or SRS. "Stereotactic radiosurgery" or "SRS"
8.22
means a specialized form of radiation therapy of the brain and spine, and which uses a
8.23
known three-dimensional reference system to localize and deliver high doses of radiation
8.24
to a target lesion with high precision in large fraction sizes over a short course of treatment.
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9.1
9.2
9.3
REVISOR
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RD3888
Subp. 45. Stray radiation. "Stray radiation" means the sum of leakage and scattered
radiation.
Subp. 46. Supervising physician. "Supervising physician" means a
9.4
Minnesota-licensed physician who accepts full medical responsibility for the performance,
9.5
practice, and activities of a registered radiologist assistant, radiology practitioner assistant,
9.6
or physician assistant according to Minnesota Statutes, section 147A.20.
9.7
9.8
Subp. 47. Target. "Target" means the part of a radiation-producing system used to
intercept a beam of accelerated particles and cause emission of other radiation.
Subp. 48. Target-skin distance (TSD). "Target-skin distance (TSD)" means the
9.10
distance measured along the beam axis from the center of the front surface of the target or
9.11
electron virtual source to the surface of the irradiated object or patient.
9.14
9.15
9.16
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9.13
Subp. 49. Termination of irradiation. "Termination of irradiation" means stopping
of irradiation until the operating conditions are reset at the control panel.
Subp. 50. Therapeutic-type protective tube housing. "Therapeutic-type protective
DR
9.12
T
9.9
tube housing" means:
A. for x-ray therapy equipment not capable of operating at 500 kilovolt peak
9.17
(kVp) or above, an x-ray tube housing constructed so the leakage radiation at a distance of
9.18
one meter from the source does not exceed 1.0 rad (0.01 Gy) in an hour when the tube is
9.19
operated at its maximum rated continuous current for the maximum rated tube potential; or
9.20
B. for x-ray therapy equipment capable of operation at 500 kilovolt peak
9.21
(kVp) or above, an x-ray tube housing constructed so leakage radiation at a distance of
9.22
one meter from the source does not exceed either 1.0 rad (0.01 Gy) in an hour or 0.1
9.23
percent of the useful beam dose rate at one meter from the source, whichever is greater,
9.24
when the machine is operated at its maximum rated continuous current for the maximum
9.25
rated accelerating potential; and
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10.1
REVISOR
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C. in either case, small areas of reduced protection are acceptable provided the
10.2
average reading over any 100 square centimeters area at one meter distance from the
10.3
source does not exceed the values given in item A or B.
10.4
Subp. 51. Therapy simulation system. "Therapy simulation system" means a
10.5
radiographic, fluoroscopic, stereotactic, cone-beam CT, or CT x-ray system including all
10.6
applicable software for:
A. localizing the volume to be irradiated during radiation therapy; and
10.8
B. establishing therapeutic irradiation field position and size.
10.9
T
10.7
Subp. 52. Treatment planning. "Treatment planning" means the process that
determines the number, orientation, type, and characteristics of the radiation beams
10.11
or electronic brachytherapy used to deliver a large dose of radiation to a patient in
10.12
order to control or cure a cancerous tumor or other problem. The radiation treatment
10.13
planning (RTP) system consists of a software package, hardware platform, and associated
10.14
peripheral devices.
DR
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10.10
10.15
Subp. 53. Useful beam. "Useful beam" means the radiation emanating from
10.16
the tube-housing port or the radiation head and passes through the aperture of the
10.17
beam-limiting device when the exposure controls are in a mode that causes the radiation
10.18
therapy system to produce radiation.
10.19
Subp. 54. Very high radiation area. "Very high radiation area" means an area
10.20
accessible to individuals where radiation levels from radiation sources external to the body
10.21
could result in an individual receiving an absorbed dose in excess of 500 rad (5 Gy) in one
10.22
hour at one meter from any surface that the radiation penetrates.
10.23
10.24
Subp. 55. Virtual source. "Virtual source" means a point from which radiation
appears to originate.
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11.2
REVISOR
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Subp. 56. Written order. "Written order" means an order either in writing or
electronically for the administration of radiation according to part 4733.0435.
REGISTRATION REQUIREMENTS
11.3
11.5
4733.0108 REGISTRATION REQUIREMENTS FOR RADIATION THERAPY
FACILITIES.
11.6
Subpart 1. Registration. The person having administrative control of a radiation
11.4
therapy system, electronic brachytherapy system, or therapy simulation system must
11.8
complete the registration and submit the applicable fee in addition to the registration
11.9
requirements found in chapter 4732. The registrant must keep the registration information
11.10
current.
T
11.7
A. Registration of the facility is not transferable as part of an ownership change.
11.12
B. All communications and reports concerning the regulations, applications,
AF
11.11
and violations filed thereunder must be addressed to the Minnesota Department of Health,
11.14
Radiation Control.
11.15
DR
11.13
C. No one may refer in advertisements to the fact that the ionizing
11.16
radiation-producing equipment is registered with the commissioner or state, or imply that
11.17
the commissioner has approved any activity under the registration.
11.18
11.19
Subp. 2. Notifications. The registrant must notify the commissioner within 30 days
of any of the following:
11.20
A. the administrator changes;
11.21
B. the radiation safety officer or other personnel identified on the registration
11.22
11.23
11.24
changes;
C. the equipment or any related registered equipment is relocated permanently
within the facility or otherwise disposed of;
4733.0108
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12.1
12.2
12.3
REVISOR
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D. the radiation-producing equipment's ownership status changes, including
sale, lease, or transfer; or
E. the facility's physical plan changes affect radiation exposure such as
12.4
remodeling by changing or removing shielded walls or barriers.
12.5
4733.0109 REGISTRATION FEES.
12.6
RD3888
The registrant must submit the fee specified in Minnesota Statutes, section 144.121,
subdivision 1a, with the initial registration application or renewal for registration of
12.8
radiation-producing therapy and simulation equipment required under chapter 4732. The
12.9
registration fee is nonrefundable.
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12.7
GENERAL ADMINISTRATION
12.11
12.12
AF
12.10
4733.0110 DATA PRIVACY.
Collection, security, and dissemination of information gathered for registration is
governed by Minnesota Statutes, chapter 13.
12.14
4733.0115 EMPLOYEE PROTECTION.
12.15
DR
12.13
Employee protection and employment discrimination issues are governed by
12.16
Minnesota Statutes, sections 181.931 to 181.937.
12.17
4733.0120 DELIBERATE MISCONDUCT.
12.18
12.19
12.20
12.21
12.22
12.23
For purposes of this chapter, "deliberate misconduct" means a registrant, employee of
a registrant, or service provider who knowingly:
A. commits intentional acts that cause or would have caused, if not detected, a
registrant to be in violation of this chapter; or
B. intentionally submits to the commissioner or the registrant information that
the submitting person knows to be incomplete or inaccurate.
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13.1
13.2
REVISOR
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4733.0125 VARIANCES.
Except for parts 4733.0108 and 4733.0109, the commissioner may grant a variance
13.3
to this chapter according to the variance procedures and criteria in parts 4717.7000
13.4
to 4717.7050.
13.5
4733.0130 INSPECTIONS.
The registrant must allow the commissioner, or commissioner's designee, at all
13.7
reasonable times, the opportunity to inspect facilities, premises, equipment, and records
13.8
for compliance with this chapter and Minnesota Statutes, sections 144.989 to 144.993.
13.9
4733.0135 ENFORCEMENT.
13.10
T
13.6
The commissioner may assess penalties for any violation of this chapter under
Minnesota Statutes, sections 144.989 to 144.993.
13.12
4733.0140 POSTING WORKER NOTICES.
Subpart 1. Notice to employees. Each registrant must prominently post an MDH
DR
13.13
AF
13.11
13.14
Form 3, "Notice to Employees," provided by the commissioner. A copy of any revision of
13.15
the Notice to Employees must be posted within 30 days of receiving the revised notice
13.16
from the commissioner. Copies of the Notice to Employees may be obtained upon request
13.17
from the Minnesota Department of Health.
13.18
13.19
13.20
13.21
Subp. 2. Posting locations. The registrant must:
A. post these notices in a prominent location to be viewed by all workers using
radiation therapy or simulation equipment; and
B. replace postings if they become illegible, defaced, or altered in any way.
REPORTS AND NOTIFICATIONS
13.22
4733.0140
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14.1
14.2
REVISOR
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4733.0160 EXPOSURE NOTIFICATIONS AND REPORTS.
Subpart 1. Notification of exposure that exceeds occupational dose limits. A
14.3
registrant must notify the commissioner if any individual worker is exposed beyond the
14.4
worker's allowable occupational dose under part 4733.0305 within 30 days of discovery.
14.5
The registrant must also notify the individual worker and provide the individual worker
14.6
with a copy of the report. Each notification and report must:
A. include the individual's dose;
14.8
B. be in writing or electronic mail; and
14.9
C. include the date of discovery, name of the registrant, name of the exposed
14.12
14.13
14.14
14.15
14.16
AF
14.11
individual worker, and date of the dose report.
Subp. 2. Individual's dose report. The registrant must provide, in writing or
electronic mail, dose information to individual workers:
A. annually if the individual's occupational dose exceeds 100 mrem (1mSv)
DR
14.10
T
14.7
TEDE; or
B. if the individual requests a report.
Subp. 3. Report upon termination. When a worker who is terminating employment
14.17
makes a written request of the worker's radiation dose, the registrant must furnish a
14.18
radiation dose report. The report must:
14.19
14.20
14.21
14.22
14.23
A. be provided to the worker within 30 days after the exposure has been
determined by the registrant;
B. cover the annual periods in which the worker's activities involved exposure
to radiation; and
C. include the dates and locations of work under the registrant.
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15.1
REVISOR
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4733.0180 REPORTS OF MEDICAL EVENTS.
15.2
Subpart 1. Notification within 24 hours. A registrant must notify the commissioner
15.3
within 24 hours of discovering any medical event as defined in part 4733.0105, subpart 25.
15.4
Subp. 2. Written report information. In addition to any notification required by
15.5
subpart 1, the registrant must submit within 30 days a written report to the commissioner
15.6
signed by the facility administrator and the individual who completed the analysis of the
15.7
medical event. The report must include:
A. the registrant's name;
15.9
B. the name of the prescribing physician;
15.10
C. a brief description of the event;
15.11
D. the root cause of the event;
15.12
E. the effect, if any, on the individual who received the radiation dose;
15.13
F. the titles of individuals involved in the event;
15.15
15.16
15.17
15.18
15.19
15.20
15.21
15.22
AF
DR
15.14
T
15.8
G. what corrective or planned actions have been taken to prevent reoccurrence,
and the dates of the corrective or planned actions;
H. the estimates of the patient's dose; and
I. verification that the registrant or referring physician notified the individual or
the individual's responsible relative or guardian and, if not, why.
Subp. 3. Notification of referring physician.
A. The registrant must notify the referring physician no later than 24 hours
after discovery of a medical event.
B. The registrant must provide the referring physician, if other than the
15.23
registrant, a copy of the report, including the information in subpart 2, no later than 30
15.24
days after discovery of the medical event.
4733.0180
15
07/17/15
REVISOR
16.3
16.4
4733.0210 GENERAL REQUIREMENTS FOR RADIATION THERAPY
FACILITIES.
Subpart 1. Equipment.
A. Radiation therapy and therapy simulator equipment must meet the
16.5
16.6
requirements of:
(1) nationally recognized standards such as Code of Federal Regulations,
16.7
16.8
title 21;
(2) the manufacturer's specifications; and
16.10
(3) this chapter.
AF
T
16.9
16.11
RD3888
GENERAL REQUIREMENTS
16.1
16.2
SGS/IL
B. When an operating parameter has been exceeded and if the parameter cannot
be corrected immediately, the radiation therapy or simulation system may be used if the
16.13
radiation safety officer and qualified medical physicist:
16.14
16.15
16.16
16.17
16.18
16.19
DR
16.12
(1) establishes written procedures, that may be used for no more than 14
days, to ensure the safe use until corrective actions have been implemented; and
(2) verifies the corrective actions have resolved the out-of-limits parameters.
Subp. 2. Radiation therapy systems; human use; veterinary use.
A. A registrant must not permit an individual to operate a radiation therapy
system for human use until the individual:
16.20
(1) meets the qualifications in part 4733.0105, subpart 37; and
16.21
(2) has completed the initial training required in subpart 5.
16.22
16.23
B. If an operator has not participated in a radiation therapy or therapy simulation
operation for more than six months since the operator's last competency audit, the
4733.0210
16
07/17/15
REVISOR
SGS/IL
RD3888
17.1
radiation safety officer or designee must observe and record the operator's performance the
17.2
next time the individual operates a radiation therapy system or therapy simulation system.
17.3
C. Radiation therapy for veterinary applications must be by, or under the
17.4
supervision of, a currently licensed veterinarian licensed by the Minnesota Board of
17.5
Veterinary Medicine. Individuals operating radiation therapy for veterinary use must:
17.6
(1) be at least 18 years of age;
17.7
(2) meet qualification criteria specified by a supervising radiation therapy
17.8
veterinarian as qualified in this item; and
(3) have completed the initial training required in subpart 5.
17.10
T
17.9
Subp. 3. Individual monitoring. In addition to the requirements of part 4733.0320,
the registrant must require that all individuals entering any area where interlocks are
17.12
necessary wear individual monitoring devices unless:
17.14
17.15
17.16
17.17
17.18
17.19
17.20
17.21
A. a radiation survey of that area has determined that radiation levels are below
that of a high-radiation area; and
DR
17.13
AF
17.11
B. power to a radiation therapy system cannot be activated or a beam cannot
be directed to that area.
Subp. 4. Operating and emergency procedures.
A. The registrant must secure radiation therapy systems that are not in operation
to prevent unauthorized use.
B. The registrant must check all safety and warning devices, including
interlocks, for proper operation according to the following schedule:
(1) emergency cutoff switches must be tested before initial use and after
17.22
17.23
any component in the emergency switch circuit is modified or repaired;
(2) safety interlocks and couch interlocks must be tested weekly; and
17.24
4733.0210
17
07/17/15
REVISOR
RD3888
(3) warning devices must be tested at intervals not to exceed one month.
18.1
C. The registrant's written operating procedures must include:
18.2
(1) operation and safety instructions to be used for the radiation therapy
18.3
18.4
SGS/IL
and simulation systems;
(2) procedures to ensure that two qualified individuals, therapists, radiation
18.5
18.6
oncologists, or medical physicists are at the therapy control console during the patient
18.7
setup and during treatment;
(3) procedures for verifying the patient's identity using two forms of
18.8
identification;
T
18.9
(4) procedures for treatment plan approval and transfer;
18.11
(5) procedures for verification of treatment plan accuracy prior to treatment
18.12
delivery;
(6) procedures for ensuring that the patient is monitored continuously
18.15
18.16
18.17
DR
18.13
18.14
AF
18.10
and without obstruction during treatment;
(7) methods for controlling access to restricted areas;
(8) methods and occasions for locking and securing the radiation therapy
system;
18.18
(9) use of individual monitoring equipment; and
18.19
(10) inspections and maintenance of the therapy and simulation systems.
18.20
D. The registrant's written emergency procedures must include:
18.21
(1) actions necessary to address equipment failures or patient emergencies;
18.22
(2) names and telephone numbers for available individuals to be contacted
18.23
if the system or console operates abnormally;
4733.0210
18
07/17/15
REVISOR
SGS/IL
RD3888
19.1
(3) notifications if the equipment fails or the patient has an emergency; and
19.2
(4) procedures for conducting analysis following any medical event.
19.3
E. The registrant must keep a copy of the current written operating and
19.4
emergency procedures at the radiation therapy and simulation system control area.
19.5
19.6
Subp. 5. Training for operating radiation therapy equipment.
A. Initial training for individuals operating radiation therapy equipment after
19.7
the effective date of this chapter must include completion of the following facility-specific
19.8
training prior to operating radiation therapy equipment:
(1) therapy equipment;
19.10
(2) simulation equipment;
19.11
(3) operating and emergency procedures;
19.12
(4) relevant quality control tests;
19.13
(5) dynamic and static acquisition;
19.15
19.16
AF
DR
19.14
T
19.9
(6) quality management program;
(7) relevant treatment planning and plan transfer; and
(8) an audit of the operator's performance by the registrant's radiation
19.17
safety officer or designee during a prescribed patient radiation therapy and therapy
19.18
simulation system operation.
19.19
B. Annual training for operators must include:
(1) health risks associated with exposure to radiation, precautions or
19.20
19.21
procedures to minimize exposure, and the purpose and use of protective devices;
19.22
(2) operating and emergency procedures;
19.23
(3) required daily quality control tests and safety checks;
4733.0210
19
07/17/15
REVISOR
responsibilities;
(5) appropriate responses to warnings made in the event of any unusual
20.3
20.4
RD3888
(4) treatment planning systems, verification systems, and operator
20.1
20.2
SGS/IL
occurrence, malfunction, or treatment planning error;
(6) applicable provisions of this chapter, including the reporting
20.5
20.6
requirements of any condition that would violate this chapter or cause unnecessary
20.7
radiation exposure; and
(7) an audit of the operator's performance by the registrant's radiation
20.8
safety officer or designee during a prescribed patient radiation therapy and therapy
20.10
simulation system operation.
20.12
C. The following individuals are exempt from the annual training requirement
AF
20.11
T
20.9
in item B:
(1) a licensed practitioner of the healing arts; or
20.14
(2) students enrolled in and participating in an accredited program for
DR
20.13
20.15
radiation therapy technology, a school of medicine, or school of osteopathy who have
20.16
radiation oncology as part of a course of study.
20.17
20.18
D. The registrant must conduct initial training following program or equipment
modifications for radiation therapy or a simulation system following changes to:
20.19
(1) the quality management program; or
20.20
(2) the radiation output from new software, modality, technology, or
20.21
radiation equipment.
20.22
4733.0215 RECORDS.
20.23
20.24
Subpart 1. Requirements. The registrant must maintain the following records
according to this chapter:
4733.0215
20
07/17/15
REVISOR
SGS/IL
RD3888
21.1
A. receipt, transfer, and disposal of all radiation therapy or simulation systems;
21.2
B. registrant's information;
21.3
C. employee training documentation, including training content, dates, and
21.4
attendees as required in part 4733.0210, subpart 5, and electronic brachytherapy training
21.5
as required in part 4733.0800, subpart 4;
21.6
D. written orders;
21.7
E. individual monitoring results, including accidents or emergencies;
21.8
F. manufacturer's specifications for any new therapy or simulation equipment
T
21.10
installed after the effective date of this chapter;
G. shielding plans, modifications, and associated radiation level verification
AF
21.9
21.11
surveys sufficient to demonstrate compliance with the dose limits for occupational workers,
21.12
according to part 4733.0305, and members of the public, according to part 4733.0315;
21.14
21.15
H. radiation safety officer training, delegation agreement, and radiation safety
DR
21.13
officer responsibilities according to part 4733.0405;
I. dated acceptance testing, commissioning, full calibration, quality control
21.16
tests, and spot check procedures as developed by a qualified medical physicist, as required
21.17
by this chapter;
21.18
21.19
21.20
21.21
J. quality management program as defined in part 4733.0425 and radiation
safety program audits according to part 4733.0420;
K. calibrations and intercomparisons for instruments, survey meters, and
electronic equipment to include:
21.22
(1) the date;
21.23
(2) the manufacturer, model number, and serial number of the instruments
21.24
that were calibrated, intercompared, or compared;
4733.0215
21
07/17/15
REVISOR
SGS/IL
RD3888
22.1
(3) the correction factors determined; and
22.2
(4) the signature or electronic signature of the individual who performed
22.3
22.4
the calibration, intercomparison, or comparison;
L. results of radiation surveys to include:
22.5
(1) the date;
22.6
(2) the purpose of the survey;
22.7
(3) the manufacturer, model number, and serial number of the instruments
used to measure radiation levels;
T
22.8
(4) a diagram or sketch of the areas surveyed;
22.10
(5) the measured dose rate at locations in each area to show compliance
22.11
AF
22.9
with the dose limits in parts 4733.0300 to 4733.0320;
(6) the calculated maximum level of radiation over a period of one year for
22.12
22.14
22.15
22.16
22.17
each restricted and unrestricted area; and
DR
22.13
(7) the signature or electronic signature of the individual who performed
the tests;
M. equipment performance measurements during full calibration and spot
checks to include:
22.18
(1) the date;
22.19
(2) the manufacturer, model number, and serial number for equipment
22.20
being tested;
(3) the manufacturer, model number, and serial number for instruments
22.21
22.22
used to calibrate equipment;
(4) the numerical results and images, if necessary;
22.23
4733.0215
22
07/17/15
REVISOR
SGS/IL
RD3888
23.1
(5) corrective actions, if necessary; and
23.2
(6) the signature or electronic signature of the individual who performed
23.3
the tests;
23.4
N. acceptance and commissioning tests performed at the time of installation;
23.5
O. daily, weekly, or monthly equipment performance tests;
23.6
P. electronic brachytherapy Institutional Review Board (IRB) documents
23.7
including:
(1) IRB approval date;
23.9
(2) IRB expiration dates; and
23.10
(3) other records as described in this chapter; and
23.13
23.14
23.15
23.16
23.17
23.18
23.19
23.20
23.21
23.22
AF
23.12
Q. other records as described in this chapter.
Subp. 2. Format and retention.
DR
23.11
T
23.8
A. Required records must be maintained so they remain legible throughout the
specified retention period.
B. Appropriate units, rad, roentgen, rem, or equivalent international system of
units (SI), must be clearly indicated on applicable records.
C. Records such as letters, drawings, or specifications must include all
supporting data such as stamps, initials, and signatures.
D. All required records listed in subpart 1, except items A, E, and G, must be
maintained for three years.
Records required in subpart 1, items A, E, and G, must be maintained as long as the
registration is active and for three years following.
4733.0215
23
07/17/15
24.1
24.2
24.3
REVISOR
SGS/IL
RD3888
4733.0220 OTHER USE OF ELECTRONICALLY PRODUCED RADIATION TO
DELIVER THERAPEUTIC RADIATION DOSAGE.
A. No one may use a radiation therapy not specifically covered elsewhere in this
24.4
chapter without first submitting a completed registration application to the commissioner.
24.5
B. The applicant or registrant must submit the following information:
(1) a detailed description of the system and its intended application;
24.7
(2) facility requirements for design, shielding, and access control;
24.8
(3) written documentation for:
T
24.6
(a) initial training for the radiation oncologist, licensed practitioner of
24.9
the healing arts, qualified medical physicist, and radiation therapist;
AF
24.10
(b) methodology for measuring doses to be administered to patients;
24.12
(c) calibration, maintenance, and repair of the device, including
24.13
24.14
24.15
24.16
24.17
24.18
DR
24.11
instruments and equipment necessary for radiation safety;
(d) radiation safety precautions and instructions; and
(e) other information required by the commissioner for reviewing the
application for registration and use.
C. The applicant or registrant must receive written approval from the
commissioner to use the device according to:
24.19
(1) any applicable regulations; and
24.20
(2) all specific conditions identified by the commissioner.
SHIELDING AND DESIGN REQUIREMENTS
24.21
4733.0220
24
07/17/15
25.1
25.2
REVISOR
SGS/IL
RD3888
4733.0250 SHIELDING DESIGN REQUIREMENTS.
Subpart 1. Shielding plan. Facility design information for a new installation of
25.3
radiation therapy or simulation systems of higher energy into a room not previously
25.4
submitted for that energy must be submitted to the commissioner prior to actual
25.5
installation of the system.
25.6
25.7
A. The registrant must document the radiation shielding installed in the
registrant's facility. Acceptable documentation is:
(1) a blue print or architectural drawing indicating installed shielding;
25.9
(2) a shielding plan; or
25.10
(3) a verification radiation survey that complies with part 4733.0265.
25.11
B. A shielding plan for simulation equipment must be completed by a service
AF
T
25.8
provider qualified according to chapter 4732, qualified medical physicist, diagnostic
25.13
radiological physicist, health physicist certified in x-ray installation, or a health physicist
25.14
certified in therapy installations.
25.15
DR
25.12
C. A shielding plan for radiation therapy equipment must be completed by a
25.16
qualified medical physicist or health physicist certified in therapy equipment installations.
25.17
Subp. 2. Barriers. Except for electronic brachytherapy below 150 kV, facilities that
25.18
have radiation therapy or simulation systems must be designed with primary and secondary
25.19
barriers to comply with the dose limits in parts 4733.0300 to 4733.0320. The barriers must:
25.20
A. be fixed except for entrance doors or beam interceptors; and
25.21
B. have shielding for neutrons, as applicable, if the radiation therapy system can
25.22
25.23
25.24
operate above ten MeV.
For simulation systems, any door that is indicated in the design as a primary barrier
must be closed during exposures.
4733.0250
25
07/17/15
26.1
26.2
REVISOR
SGS/IL
RD3888
4733.0255 FACILITY DESIGN REQUIREMENTS.
Subpart 1. Control console. Except for electronic brachytherapy below 150 kV, the
26.3
radiation therapy console must be located outside the high-radiation area. Instrumentation,
26.4
readouts, and controls on the radiation therapy system control console must be clearly
26.5
identified and easily discernible.
26.6
Subp. 2. Warning lights. Except for electronic brachytherapy below 150 kV and
simulation rooms, radiation therapy room entrances must have warning lights in readily
26.8
visible positions near the outside of all access doors to indicate when the useful beam
26.9
is "ON."
26.10
T
26.7
Subp. 3. Emergency cutoff couch switches. Except for simulation systems, an
emergency cutoff couch switch must be located on either side of the primary beam and
26.12
easily identifiable in all high-radiation areas. The cutoff switch must include a manual
26.13
reset so that the therapy system cannot be restarted from the therapy system control
26.14
console without resetting the cutoff switch.
DR
AF
26.11
26.15
Subp. 4. Interlocks. Except for electronic brachytherapy below 150 kV and
26.16
simulation rooms, interlocks or safety devices must be in place so all access to the room
26.17
is blocked before irradiation is initiated or continued. If the useful radiation beam is
26.18
interrupted by any door opening or tripping of the safety device, restoring the system to
26.19
operation without closing the door or resetting the safety device must not be possible
26.20
unless the operator closes the door or resets the safety device and manually reinitiates
26.21
irradiation at the control console. In addition:
26.22
26.23
26.24
26.25
A. each entrance into a target area or other high-radiation area must have two
safety interlocks that shut down the equipment when the barrier is breached;
B. each safety interlock must be on a circuit that allows it to operate
independently of the therapy system; and
4733.0255
26
07/17/15
27.1
27.2
27.3
27.4
REVISOR
SGS/IL
RD3888
C. all safety interlocks must be designed so that any defect or component failure
in the safety interlock system prevents operation of the radiation therapy system.
Subp. 5. Patient viewing system.
A. For radiation therapy rooms, a closed-circuit television, or an equivalent
27.5
system, must be provided to permit continuous observation of the patient during irradiation
27.6
and located so the operator can see the patient from the control console at all times.
B. For simulation rooms, the viewing system must be designed so that the
27.8
operator at the control panel may directly observe the patient, any other individual in
27.9
the room, and any doorway into the room.
27.10
T
27.7
Subp. 6. Audio communication. Except for veterinary use, two-way audio
communication between the patient and the operator must be provided at the control
27.12
panel. When excessive noise levels or treatment requirements make audio communication
27.13
impractical, other methods of communication must be used.
27.14
4733.0260 MODIFICATION.
27.16
27.17
27.18
27.19
27.20
27.21
DR
27.15
AF
27.11
When modifications to the radiation therapy area or simulation area are made, the
registrant must:
A. perform a verification radiation survey ensuring the doses to any individuals
do not exceed the limits in this chapter;
B. equip therapy equipment with beam direction interlocks or add additional
shielding to comply with parts 4733.0250 to 4733.0275; and
C. document modifications made and the results of all radiation surveys
27.22
according to part 4733.0265.
27.23
4733.0265 RADIATION SURVEYS.
27.24
27.25
Subpart 1. Radiation surveys. A radiation survey must encompass all directions
around the equipment and surrounding areas and must be performed:
4733.0265
27
07/17/15
REVISOR
SGS/IL
RD3888
28.1
A. before the first use;
28.2
B. after making any change in the shielding;
28.3
C. after installing or relocating the accelerator or simulation equipment; and
28.4
D. before using the equipment in a manner that could result in increased
28.5
28.6
radiation levels in areas outside the shielded area.
Subp. 2. Performance method. The radiation survey must cover the radiation levels
at the operator position and at pertinent points outside the room during normal operation.
28.8
The radiation safety officer or designee must perform the radiation survey with the
28.9
equipment in a "BEAM-ON" condition, with the largest available field and with a scattering
28.10
phantom in the useful beam of radiation, if applicable, to ensure that radiation levels in
28.11
restricted areas are not likely to expose the personnel in excess of the limits of this chapter.
28.12
Subp. 3. Notification. If the results of the radiation survey indicate levels above dose
28.14
28.15
28.16
28.17
AF
limits in parts 4733.0300 to 4733.0320, the registrant must:
DR
28.13
T
28.7
A. inactivate and secure the equipment;
B. notify the commissioner within 24 hours of discovery; and
C. perform corrective actions.
When the radiation survey results document that the corrective actions have been
28.18
completed and the registrant has complied with the dose requirements in parts 4733.0300
28.19
to 4733.0320, the registrant may begin to use the equipment.
28.20
4733.0270 CAUTION SIGNS.
28.21
Subpart 1. Standard radiation symbol and labeling. Each radiation sign or label
28.22
must bear the standard symbol specified in this subpart and the printed warning, in capital
28.23
block letters, specified in subpart 4. The standard symbol for designating any radiation
28.24
hazard is a circle with three propeller-like blades arranged around it as illustrated:
4733.0270
28
REVISOR
SGS/IL
RD3888
AF
T
07/17/15
A. cross-hatched area must be magenta, purple, or black; and
29.2
B. the background must be yellow.
29.3
DR
29.1
Subp. 2. Additional information on signs and labels. In addition to the contents
29.4
of signs and labels prescribed in this part, the registrant must provide, on or near the
29.5
required signs and labels, additional information to make individuals aware of potential
29.6
radiation exposures.
29.7
Subp. 3. Prohibitions on use of symbol. The registrant may not use the specified
29.8
radiation symbol for any purpose other than designating or referring to an area of
29.9
applicable radiation levels.
29.10
29.11
29.12
29.13
Subp. 4. Posting and labeling requirements. The registrant must post conspicuous
radiation warning labels in areas where a radiation hazard might exist.
A. The warning "CAUTION RADIATION AREA" or "DANGER RADIATION
AREA" must appear on signs in an area in which a radiation hazard may exist.
4733.0270
29
07/17/15
30.1
REVISOR
SGS/IL
RD3888
B. The warning "CAUTION HIGH-RADIATION AREA" or "DANGER
30.2
HIGH-RADIATION AREA" must appear on signs in an area in which a high-radiation
30.3
hazard may exist.
30.4
C. The warning "CAUTION VERY HIGH-RADIATION AREA" or "DANGER
30.5
VERY HIGH-RADIATION AREA" must appear on signs in an area in which a very
30.6
high-radiation hazard may exist.
30.7
4733.0275 WARNING AND CONTROL DEVICES FOR HIGH- AND VERY
HIGH-RADIATION AREAS.
30.8
30.9
A. Each entrance or access point to a high- or very high-radiation area must be:
(1) equipped with a control device that reduces the level of radiation so
T
30.10
that an individual cannot receive a dose in excess of 100 millirems (1.0 mSv) in one
30.12
hour after entry into the area; or
AF
30.11
(2) equipped with a warning device that uses a visible or audible alarm
30.13
to alert an individual entering the high- or very high-radiation area and other nearby
30.15
non-occupationally exposed workers.
30.16
DR
30.14
B. In place of the controls required under item A, a registrant may substitute
30.17
continuous direct or electronic surveillance that is capable of preventing unauthorized entry.
30.18
DOSE REQUIREMENTS
30.19
4733.0300 DETERMINATION OF ACCUMULATED OCCUPATIONAL DOSE.
30.20
Subpart 1. Determination of prior occupational dose. The registrant must
30.21
determine the occupational dose an individual received during the current year for each
30.22
individual who is likely to receive an occupational dose in a year requiring monitoring
30.23
according to part 4733.0305.
30.24
30.25
Subp. 2. Complying with determination of prior occupational dose.
A. A registrant may:
4733.0300
30
07/17/15
REVISOR
SGS/IL
RD3888
(1) accept, as a record of the occupational dose that the individual received
31.1
31.2
during the current year, a written signed statement from the individual or from the
31.3
individual's most recent employer for work involving radiation exposure that discloses the
31.4
nature and amount of any occupational dose that the individual received; or
31.5
(2) accept, as the record of cumulative radiation dose, an up-to-date form,
31.6
signed by the individual and countersigned by an official of the most recent employer for
31.7
work involving radiation exposure, or the individual's current employer, if the individual
31.8
is not employed by the registrant.
B. The registrant must record all the required history in a legible record.
31.10
C. If the registrant is unable to obtain a complete record of an individual's
T
31.9
current and previously accumulated occupational dose, the registrant must assume the
31.12
allowable dose limits for the individual is reduced by 1.25 rem (12.5 mSv) for each quarter
31.13
for which records were unavailable and the individual was engaged in activities that could
31.14
have resulted in occupational radiation exposure.
31.15
4733.0305 OCCUPATIONAL DOSE LIMITS FOR ADULTS.
DR
31.16
AF
31.11
Subpart 1. Occupational dose control. The registrant must prevent individual adults
31.17
from receiving occupational doses that exceed the following annual dose limit, which is
31.18
the lesser of:
31.19
A. the total effective dose equivalent being equal to five rem (0.05 Sv); or
31.20
B. the sum of the deep-dose equivalent and the committed dose equivalent to
31.21
31.22
31.23
any individual organ or tissue other than the lens of the eye equal to 50 rem (0.5 Sv); and
C. the annual limits to the lens of the eye, to the skin, and to the extremities,
which are:
(1) a lens dose equivalent of 15 rem (0.15 Sv); and
31.24
4733.0305
31
07/17/15
REVISOR
32.3
32.4
32.5
32.6
RD3888
(2) a shallow-dose equivalent of 50 rem (0.5 Sv) to the skin or to any
32.1
32.2
SGS/IL
extremity.
Subp. 2. Dose equivalent.
A. The portion of the body receiving the highest exposure is the assigned
deep-dose equivalent and shallow-dose equivalent.
B. The deep-dose equivalent, lens dose equivalent, and shallow-dose
equivalent may be assessed from a radiation survey or other radiation measurements for
32.8
demonstrating compliance with the occupational dose limits if the individual monitoring
32.9
device was not in the region of highest potential exposure or the results of individual
32.10
monitoring are unavailable.
C. When an individual wears a protective apron while working with
AF
32.11
T
32.7
32.12
radiation-producing equipment and monitoring as specified in part 4733.0320, the
32.13
effective dose equivalent for external radiation must be determined as follows:
(1) when only one individual monitoring device is used that is located at
DR
32.14
32.15
the neck (collar) outside the protective apron, the reported deep-dose equivalent must be
32.16
the effective dose equivalent for external radiation;
32.17
(2) when only one individual monitoring device is used that is located at
32.18
the neck (collar) outside the protective apron, the reported deep-dose equivalent value
32.19
multiplied by 0.3 must be the effective dose equivalent for external radiation; or
(3) when individual monitoring devices are worn, both under the protective
32.20
32.21
apron at the waist and outside the protective apron at the neck, the effective dose
32.22
equivalent for external radiation must be assigned the value of the sum of the deep-dose
32.23
equivalent reported for the individual monitoring device located at the waist under the
32.24
protective apron multiplied by 1.5 and the deep-dose equivalent reported for the individual
32.25
monitoring device located at the neck outside the protective apron multiplied by 0.04.
4733.0305
32
07/17/15
33.1
33.2
33.3
REVISOR
SGS/IL
RD3888
D. Any alternative method of determining dose must be approved by the
commissioner.
Subp. 3. Reduction of dose. The registrant must reduce the dose that an individual
33.4
is allowed to receive in the current year by the amount of occupational dose received
33.5
while employed by any other facility during the current year.
33.6
Subp. 4. Dose information. The employee must supply information to the registrant
33.7
about other current occupational doses received due to employment at multiple facilities.
33.8
4733.0310 DOSE EQUIVALENT TO AN EMBRYO OR FETUS.
A. When a woman declares her pregnancy in writing, the registrant must
T
33.9
ensure that the dose equivalent to an embryo or fetus during the entire pregnancy, due to
33.11
occupational exposure of a declared pregnant woman, does not exceed 0.5 rem (5 mSv).
33.13
33.14
B. The registrant must make efforts to avoid substantial variation above a
uniform monthly exposure rate to a declared pregnant woman to satisfy the limit in item A.
DR
33.12
AF
33.10
C. A registrant must make a reasonable effort to limit the occupational dose
33.15
to the embryo or fetus to 0.05 rem (0.5 mSv) in any one month of pregnancy, excluding
33.16
medical exposure.
33.17
D. If the dose to the embryo or fetus is found to have exceeded 0.5 rem (5 mSv)
33.18
or is within 0.05 rem (0.5 mSv) of this dose by the time the woman declares her pregnancy,
33.19
the registrant must ensure that additional occupational dose equivalent to the embryo or
33.20
fetus does not exceed 0.05 rem (0.5 mSv) during the remainder of the pregnancy.
33.21
4733.0315 RADIATION DOSE LIMITS FOR THE PUBLIC.
33.22
A. A registrant must not use radiation-producing equipment in a manner that
33.23
could result in an individual member of the public receiving an annual effective dose
33.24
equivalent in excess of 0.1 rem (one mSv).
4733.0315
33
07/17/15
34.1
REVISOR
does not exceed 0.002 rem (0.02 mSv) in any one hour.
34.3
4733.0320 INDIVIDUAL MONITORING.
34.5
34.6
RD3888
B. A registrant must conduct operations so that the dose in any unrestricted area
34.2
34.4
SGS/IL
Subpart 1. Exposure levels. A registrant must monitor exposures to radiation at levels
sufficient to demonstrate compliance with the occupational dose limits of this chapter.
Subp. 2. Requirements for individual monitoring. A registrant must supply the
34.7
following personnel with appropriate individual monitoring devices and require personnel
34.8
to wear the monitoring devices:
34.11
34.12
limits in part 4733.0305;
T
34.10
A. adults likely to receive, in one year, a dose in excess of ten percent of the
B. minors likely to receive, in one year, a deep dose equivalent in excess of
0.1 rem (1.0 mSv);
AF
34.9
C. declared pregnant women likely to receive, during the entire pregnancy, a dose
34.14
in excess of 0.1 rem (1.0 mSv). All of the occupational doses under part 4733.0305 apply to
34.15
the declared pregnant worker as long as the embryo or fetus dose limit is not exceeded; and
34.16
34.17
DR
34.13
D. individuals entering a high- or very high-radiation area.
Subp. 3. Required instruction. The registrant must ensure that all individuals who
34.18
are likely to receive an occupational dose in excess of 100 millirems (1 mSv) in a year
34.19
receive annual training as required by part 4733.0210, subpart 5.
RADIATION SAFETY
34.20
34.21
34.22
4733.0400 REGISTRANT'S SAFETY RESPONSIBILITIES.
A. The registrant is responsible for the operation of radiation therapy
34.23
systems, electronic brachytherapy, and therapy simulation systems under the registrant's
34.24
administrative control and must ensure that the requirements of this chapter are met.
4733.0400
34
07/17/15
35.1
REVISOR
SGS/IL
RD3888
B. If the registrant is not the radiation safety officer, the registrant must appoint
35.2
a radiation safety officer who meets the qualifications in part 4733.0405.
35.3
4733.0405 RADIATION SAFETY OFFICER (RSO).
35.4
Subpart 1. Radiation safety officer training. The radiation safety officer must
35.5
be either a licensed practitioner of the healing arts, qualified medical physicist, or an
35.6
individual who:
35.7
A. has completed training according to the responsibilities in subpart 4; and
35.8
B. has obtained written attestation, signed by a qualified medical physicist, that
the individual has satisfactorily completed the requirements in item A and has achieved
35.10
a level of radiation safety knowledge sufficient to function independently as a radiation
35.11
safety officer for radiation therapy.
AF
T
35.9
35.12
Subp. 2. Agreement. The registrant must appoint a radiation safety officer, who
35.13
agrees in writing, to be responsible for implementing the radiation protection program.
35.15
35.16
35.17
Subp. 3. Authority. The registrant must provide the radiation safety officer sufficient
DR
35.14
authority, organizational freedom, time, resources, and management prerogative to:
A. identify radiation safety problems;
B. initiate, recommend, or provide corrective actions;
35.18
C. stop unsafe operations; and
35.19
D. verify the implementation of corrective actions.
35.20
Subp. 4. RSO responsibilities. The radiation safety officer must:
35.21
A. establish a quality management program;
35.22
B. establish and oversee operating and emergency procedures;
35.23
C. determine personnel required to have individual monitoring according to
35.24
part 4733.0320;
4733.0405
35
07/17/15
36.1
36.2
36.3
36.4
REVISOR
SGS/IL
RD3888
D. investigate each known or suspected case of an individual being exposed to
radiation levels in excess of limits established by this chapter;
E. assume control and institute corrective actions, including shutdown of
operations in emergency or unsafe conditions;
36.5
F. design and oversee initial, annual, and other required trainings;
36.6
G. ensure equipment maintenance is performed according to this chapter;
36.7
H. perform or arrange to have performed:
(1) radiation surveys;
36.9
(2) radiation safety program audits according to part 4733.0420;
36.10
(3) calibrations and equipment performance evaluations;
36.11
(4) review of quality control tests and spot checks; and
36.12
(5) initial and annual operator competency audits.
36.13
4733.0410 QUALIFIED MEDICAL PHYSICIST SUPPORT.
36.15
36.16
AF
DR
36.14
T
36.8
Subpart 1. Physicist responsibilities. The registrant must employ or contract with a
qualified medical physicist. The qualified medical physicist is responsible for:
A. full calibrations and radiation protection surveys required by this chapter;
36.17
B. supervising and reviewing dosimetry;
36.18
C. acquiring beam data, transferring it for computerized dosimetry, and
36.19
36.20
36.21
supervising its use;
D. managing the quality assurance, including establishing written procedures
and reviewing required quality control and safety checks;
36.22
E. consulting for treatment planning, as needed; and
36.23
F. performing calculations and assessments regarding medical events.
4733.0410
36
07/17/15
37.1
REVISOR
SGS/IL
RD3888
Subp. 2. Availability. The registrant must have emergency procedures in place to
37.2
address the specific actions that must be taken if problems, failures, or emergencies occur
37.3
and the qualified medical physicist is not immediately available.
37.4
Subp. 3. Verification. The qualified medical physicist must develop a procedure for
37.5
verifying the treatment plan before it is transferred to the treatment equipment system and
37.6
before it is implemented. The qualified medical physicist must verify the treatment plan
37.7
and plan transfer before:
A. the first treatment of five or less treatment fractions; and
37.9
B. the third fraction for treatments over five fractions.
T
37.8
Subp. 4. Alternative verification. If a qualified medical physicist is not available
37.11
for an emergency treatment plan, the radiation oncologist may verify and document the
37.12
treatment plan and the plan transfer.
37.13
4733.0420 RADIATION PROGRAM AUDITS.
37.15
37.16
37.17
Subpart 1. Program review. A registrant must review at intervals not to exceed
DR
37.14
AF
37.10
12 months:
A. all aspects of the quality management program;
B. medical events and incidents that could have resulted in a medical event;
37.18
C. required trainings;
37.19
D. operating and emergency procedures;
37.20
E. annual calibrations, periodic spot checks, and other applicable quality control
37.21
and safety checks;
37.22
F. dosimetry and survey equipment calibrations; and
37.23
G. other items identified by the registrant, radiation safety officer, or qualified
37.24
medical physicist.
4733.0420
37
07/17/15
38.1
38.2
REVISOR
38.5
38.6
RD3888
Subp. 2. Corrective actions. The registrant must correct any noncompliance issues
found during the audit within 30 days.
QUALITY MANAGEMENT PROGRAM
38.3
38.4
SGS/IL
4733.0425 QUALITY MANAGEMENT PROGRAM.
A registrant subject to part 4733.0500, 4733.0520, or 4733.0800 must implement a
site-specific quality management program. The program must include at a minimum:
A. therapy and simulation procedure written orders according to part 4733.0435;
38.8
B. notification procedures for medical events in accordance with part 4733.0180;
38.9
C. procedures to ensure that:
T
38.7
(1) each administration is in accordance with the written order;
38.11
(2) radiation therapy final plans of treatment and related calculations are
38.13
38.14
38.15
38.16
in accordance with the written order by:
DR
38.12
AF
38.10
(a) checking both manual and computer-generated dose calculations to
verify they are correct and in accordance with the written order; and
(b) verifying that any computer-generated calculations are correctly
transferred into the therapy system consoles; and
(3) any unintended deviation from the written order is identified and
38.17
38.18
evaluated and appropriate action is taken.
38.19
4733.0435 ORDERING THERAPY OR SIMULATION PROCEDURES.
38.20
38.21
Subpart 1. Therapy procedure written orders.
A. The order for radiation therapy treatments must be made by:
(1) a licensed practitioner of the healing arts; or
38.22
4733.0435
38
07/17/15
REVISOR
SGS/IL
RD3888
(2) a physician assistant supervised by a therapeutic radiologist or a
39.1
39.2
radiation oncologist if the ordering of therapeutic procedures is designated in the
39.3
physician-physician assistant agreement authorized under Minnesota Statutes, section
39.4
147A.20.
39.5
39.6
39.7
B. The written order for radiation therapy treatments must be available at the
time of the treatment.
C. The written order for a therapeutic procedure must include the:
(1) date;
39.9
(2) patient's identity;
39.10
(3) identity of the individual who is ordering the treatment, by a signature,
an electronic signature, or equivalent procedure;
AF
39.11
T
39.8
(4) type and energy of beam;
39.13
(5) treatment site;
39.14
39.15
39.16
39.17
DR
39.12
(6) total dose;
(7) dose per fraction; and
(8) total number of fractions and number of fractions per day.
D. A written order may be revised provided that the revision is dated and signed
39.18
by a radiation oncologist prior to the administration of the therapeutic dose or the next
39.19
fractional dose.
39.20
39.21
Subp. 2. Therapy simulator system procedure orders.
A. The order for a simulation examination must be made only by:
39.22
(1) a licensed practitioner of the healing arts;
39.23
(2) an advanced practice nurse;
4733.0435
39
07/17/15
REVISOR
SGS/IL
RD3888
40.1
(3) a certified nurse practitioner; or
40.2
(4) a physician assistant supervised by a therapeutic radiologist or a
40.3
radiation oncologist if the ordering of therapeutic procedures is designated in the
40.4
physician-physician assistant agreement authorized under Minnesota Statutes, section
40.5
147A.20.
40.6
40.7
40.8
B. The written order for simulation procedures must be available at the time
of the examination.
C. The order for a simulation procedure must include the:
(1) date;
40.10
(2) patient's identity;
40.11
(3) identity of the individual who is ordering the examination, by a
AF
40.12
signature, an electronic signature, or equivalent procedure;
(4) intended modality;
40.14
(5) simulation site;
40.16
40.17
40.18
40.19
DR
40.13
40.15
T
40.9
(6) patient positioning; and
(7) immobilization devices and markers.
CALIBRATIONS
4733.0440 RADIATION SURVEY OR MEASUREMENT INSTRUMENTS.
Subpart 1. Requirements. Each facility authorized to operate a radiation therapy
40.20
system in accordance with parts 4733.0500, 4733.0520, and 4733.0800 must possess
40.21
calibrated portable radiation monitoring equipment.
40.22
Subp. 2. Calibration. The registrant must ensure the correct response to radiation
40.23
by calibrating each radiation instrument at intervals not to exceed 12 months, and after
40.24
any repair. The instrument must:
4733.0440
40
07/17/15
REVISOR
SGS/IL
RD3888
41.1
A. meet energy levels over a range appropriate for the use;
41.2
B. be accurate within plus or minus 20 percent over the instrument's applicable
41.3
41.4
41.5
41.6
range of the instrument;
C. be traceable to its calibration standard at the National Institute of Standards
and Technology (NIST); and
D. for noninvasive kVp meters, be calibrated by the manufacturer or an
accredited calibration laboratory.
41.8
4733.0445 DOSIMETRY SYSTEM.
41.9
T
41.7
Subpart 1. Requirements. The registrant must use a calibrated dosimetry system for
quality control measurements. The system must be calibrated by the National Institute
41.11
for Standards and Technology (NIST) or by an American Association of Physicists in
41.12
Medicine (AAPM) Accredited Dosimetry Calibration Laboratory (ADCL).
41.14
41.15
A. For beams with energies greater than 1.0 MV (1.0 MeV), the dosimetry
DR
41.13
AF
41.10
system must be calibrated for Cobalt-60.
B. For beams with energies equal to or less than 1.0 MV (1.0 MeV), the
41.16
dosimetry system must have been calibrated at an energy (energy range) appropriate
41.17
for the radiation being measured.
41.18
41.19
41.20
Subp. 2. Calibrations. Calibration must be performed by, or under the direct
supervision of a qualified medical physicist.
A. The calibration must be performed:
41.21
(1) at least every 24 months; and
41.22
(2) after any servicing that might have affected system calibration.
4733.0445
41
07/17/15
REVISOR
SGS/IL
RD3888
42.1
B. Instead of calibrating the system every 24 months as in item A, the registrant
42.2
may use an intercompared system that has been calibrated within the previous 48 months.
42.3
Each calibrated system used must have been calibrated within the past 24 months.
42.4
42.5
Subp. 3. Intercomparison.
A. The intercomparison results must show that the system's calibration factor
42.6
has not changed by more than two percent. The intercomparison result cannot be used
42.7
to change the calibration factor.
42.8
B. When intercompared dose-monitoring systems are used for calibrating
radiation therapy systems, the units must be compatible with the therapy system.
42.10
4733.0455 TREATMENT PLAN APPROVAL.
42.12
Subpart 1. Approval. Prior to a patient's first treatment, plan approval must be
AF
42.11
T
42.9
completed and signed by a radiation oncologist and:
A. a qualified medical physicist; or
42.14
B. a certified medical dosimetrist.
42.15
DR
42.13
Subp. 2. Noncertified dosimetrists. If the treatment plan has been prepared by a
42.16
dosimetrist who is not certified by the Medical Dosimetrist Certification Board (MDCB),
42.17
the radiation oncologist and either a certified medical dosimetrist or a qualified medical
42.18
physicist must review and approve the treatment plan before a patient's first treatment.
EQUIPMENT REQUIREMENTS
42.19
42.20
42.21
42.22
4733.0500 RADIATION THERAPY SYSTEMS OF LESS THAN 500 kV.
Subpart 1. Leakage radiation.
A. When the x-ray tube is operated at its maximum-rated tube current and
42.23
maximum kV, the leakage air kerma rate must not exceed the value specified at the
42.24
distance specific to that radiation therapy system's classification.
4733.0500
42
07/17/15
43.1
43.2
REVISOR
radiation therapy system indicating the radiation system:
(1) has been measured under conditions which provide maximum leakage
radiation; or
(2) does not exceed the value specified at the distance specified for the
43.5
43.7
43.8
43.9
classification of that x-ray system.
C. Compliance is determined by measurements averaged over an area of 100
square centimeters.
D. The registrant must ensure that a leakage measurement is performed at
T
43.6
RD3888
B. The registrant must obtain documentation from the manufacturer for each
43.3
43.4
SGS/IL
installation and whenever the tube is changed. The registrant must also ensure that leakage
43.11
measurements are performed at least once every five years specifically:
AF
43.10
(1) for contact therapy systems, leakage kerma rate must not exceed 100
43.12
milliroentgens (mR) in one hour at five centimeters from the surface of the tube housing
43.14
assembly;
43.15
DR
43.13
(2) for systems at or below 150 kV, the leakage measured at any position
43.16
five centimeters from the tube housing assembly must not exceed 100 mrad (1.0 mGy) in
43.17
any one hour; and
(3) for systems greater than 150 kVp and less than 500 kV, the leakage
43.18
43.19
kerma rate measured at a distance of one meter from the target in any direction must
43.20
not exceed 1.0 rad (1.0 cGy) in any one hour. The air kerma rate measurement may be
43.21
averaged over areas no larger than 100 square centimeters. In addition, the kerma rate
43.22
at a distance of five centimeters from the surface of the tube housing assembly must not
43.23
exceed 30 rad (30 cGy) per hour.
43.24
Subp. 2. Diaphragms, cones, beam-limiting devices, or blocks.
4733.0500
43
07/17/15
44.1
44.2
44.3
REVISOR
SGS/IL
RD3888
A. Permanent diaphragms or cones used for limiting the useful beam must
provide at least the same degree of attenuation as required for the tube housing assembly.
B. Adjustable or removable diaphragms, cones, beam-limiting devices, or
44.4
blocks must not transmit more than five percent of the useful beam for the most penetrating
44.5
beam used. When adjustable beam-limiting devices are used, the position and shape of the
44.6
radiation field must be indicated by a light beam.
44.7
Subp. 3. Filter systems. The filter system must be designed so that:
A. filters cannot be accidentally displaced at any possible tube orientation;
44.9
B. an interlock system must prevent irradiation if the proper filter is not in place;
44.10
C. the air kerma rate escaping from the filter slot does not exceed 1.0 rad (1.0
44.13
44.14
AF
44.12
cGy) per hour at one meter under any operating conditions; and
D. each filter is marked as to its material construction and its thickness.
Subp. 4. X-ray tubes and tube housings.
DR
44.11
T
44.8
A. The x-ray tube must be mounted so that it cannot accidentally turn or slide
44.15
with respect to the housing aperture. The tube housing assembly must be capable of being
44.16
immobilized for stationary portal treatments.
44.17
B. The tube housing assembly must be marked so that determining the location
44.18
of the source to within five millimeters is possible, and such marking is readily accessible
44.19
during calibration procedures.
44.20
C. Contact therapy tube housing assemblies must have a removable shield
44.21
equivalent in attenuation to 0.5 millimeters of lead at 100 kV, which can be positioned
44.22
over the entire useful beam exit port during periods when the beam is not in use.
44.23
Subp. 5. Exposure controls, control panels, and indicators.
4733.0500
44
07/17/15
45.1
45.2
REVISOR
SGS/IL
RD3888
A. A system must have a control device that terminates the radiation after a
preset time interval has elapsed and must:
45.3
(1) have a display at the treatment control panel;
45.4
(2) have a preset time selector and an elapsed time or time remaining
45.5
indicator;
(3) have a cumulative timer that has a "BEAM-ON" indicator to show the
45.7
instrument is radiating and retains its reading after radiation is interrupted or terminated.
45.8
The panel must require resetting the elapsed-time indicator after radiation is terminated
45.9
and before irradiation can be restarted;
short as one second;
AF
(4) permit accurate presetting and determination of exposure times as
45.10
45.11
T
45.6
45.12
(5) not permit an exposure if set at zero;
45.13
(6) not activate until the shutter is opened when radiation is controlled by
a shutter mechanism unless calibration includes a timer error correction to compensate
45.15
for mechanical lag; and
45.16
45.17
45.18
DR
45.14
(7) be accurate to within 1.0 percent of the selected value or one second,
whichever is greater.
B. The control panel, in addition to the provisions in item A, must have:
(1) an indicator of whether electrical power is available at the control panel
45.19
45.20
and if activation of the x-ray tube is possible;
45.21
(2) an indicator for whether x-rays are being produced;
45.22
(3) an indicator for kVp and x-ray tube current;
45.23
(4) the means for terminating an exposure at any time;
45.24
(5) a locking device that will prevent unauthorized system use; and
4733.0500
45
07/17/15
REVISOR
46.3
RD3888
(6) for radiation therapy systems manufactured after July 9, 1997, a
46.1
46.2
SGS/IL
positive display of specific filters in the beam.
C. When a control panel can energize more than one x-ray tube:
46.4
(1) it must be possible to activate only one x-ray tube at any time;
46.5
(2) the control panel must have an indicator identifying which x-ray tube is
46.6
activated; and
(3) the tube housing assembly must have an indicator showing when that
46.7
46.9
tube is energized.
T
46.8
D. There must be a means of determining the central axis target-skin distance
to within one centimeter and of reproducing this measurement to within two millimeters
46.11
thereafter.
46.12
AF
46.10
E. Unless bringing the x-ray output to the prescribed exposure parameters
is possible within five seconds after the x-ray "ON" switch is energized, the following
46.14
conditions must be met:
46.15
46.16
DR
46.13
(1) the beam must be attenuated by shutters having a lead equivalency not
less than that of the tube housing assembly;
(2) after the unit is at operating parameters, the shutters must be controlled
46.17
46.18
by the operator from the control panel; and
(3) an indication of shutter position must appear at the control panel.
46.19
46.20
F. Each radiation therapy system equipped with a beryllium or other
46.21
low-filtration window must be clearly labeled as such on the tube housing assembly and
46.22
must have a permanent warning device on the control panel that activates when no
46.23
additional filtration is present to indicate that the dose rate is very high.
4733.0500
46
07/17/15
47.1
REVISOR
SGS/IL
RD3888
Subp. 6. Facility design requirements. Except for electronic brachytherapy, in
47.2
addition to the requirements in parts 4733.0250 to 4733.0260, treatment rooms that
47.3
contain a radiation therapy system capable of operating in a range of 150 kV to 500 kV
47.4
must meet the following requirements:
47.7
47.8
47.9
47.10
47.11
interceptors;
B. the control panel must be located outside the treatment room or in a totally
enclosed booth which has a ceiling inside the room;
C. interlocks must be provided so that all entrance doors, including doors to any
T
47.6
A. all protective barriers must be fixed except for entrance doors or beam
interior booths, must be closed before treatment can be initiated or continued;
AF
47.5
D. if the beam is interrupted by any door opening, it must not be possible to
restore the machine to operation without closing the door and reinitiating irradiation
47.13
by manual action at the control panel; and
47.14
DR
47.12
E. when a door is opened while the radiation therapy system is activated, the air
47.15
kerma rate at a distance of one meter from the source must be reduced to less than 100
47.16
mrad (1.0 mGy) per hour.
47.17
4733.0505 OPERATING AND EMERGENCY PROCEDURES FOR RADIATION
THERAPY SYSTEMS OF LESS THAN 500 kV.
47.18
47.19
47.20
47.21
47.22
Subpart 1. Operating procedures. In addition to the requirements in part 4733.0210,
subpart 4, item C, the procedures must include:
A. when a patient must be held in position for radiation therapy, the mechanical
supporting or restraining devices that will be used;
47.23
B. procedures for restricting individuals from holding the tube housing assembly
47.24
during operation unless the assembly is designed to require such holding and the peak tube
4733.0505
47
07/17/15
REVISOR
SGS/IL
RD3888
48.1
potential of the system does not exceed 150 kV. In these cases, the holder must wear a
48.2
protective apron and gloves of not less than 0.5 millimeters lead equivalency at 100 kV; and
48.3
48.4
48.5
C. procedures that prohibit individuals other than the patient in the treatment
room during exposures from radiation therapy systems operating above 150 kV.
Subp. 2. Emergency procedures. In addition to the requirements in part 4733.0210,
subpart 4, item D, the procedures must include notifying the manufacturer and the
48.7
commissioner of a medical event.
48.8
4733.0510 FULL CALIBRATION MEASUREMENTS RADIATION THERAPY
SYSTEMS OF LESS THAN 500 kV.
48.9
48.10
T
48.6
Subpart 1. Frequency. Full system calibration must be performed by, or under the
direct supervision of, a qualified medical physicist. Before use, full system calibration
48.12
must be performed:
AF
48.11
A. following installation or reinstallation;
48.14
B. following any change that would alter the calibration or other characteristic
48.15
48.16
DR
48.13
of the therapy beam;
C. whenever quality control check measurements indicate that the radiation
48.17
output differs by more than five percent from the value obtained at the last full calibration
48.18
and the difference cannot be reconciled; and
48.19
D. at intervals not to exceed 12 months. The registrant may conduct individual
48.20
elements of a full calibration at different times provided all parameters for all energies are
48.21
completed at intervals not to exceed 12 months.
48.22
Subp. 2. Full calibration. The registrant must establish, document, and implement
48.23
full calibration procedures developed by a qualified medical physicist. Full calibrations
48.24
must be performed at intervals within the tolerances not to exceed those specified in either
48.25
"Comprehensive QA for Radiation Oncology: Report of AAPM Radiation Therapy;
4733.0510
48
07/17/15
REVISOR
SGS/IL
RD3888
49.1
AAPM report No. 46," prepared by Committee Task Group 40 or "Task Group 142
49.2
report: Quality assurance of medical accelerators" unless the qualified medical physicist
49.3
determines and documents that a specific recommendation of these reports is not warranted.
49.4
Subp. 3. Exception. Notwithstanding the requirements of this subpart:
49.5
A. full calibration of radiation therapy systems with multimode capabilities is
49.6
required only for those modes or energies that are not within their acceptable range; and
49.7
B. if the repair, replacement, or modification does not affect all energies, full
calibration must be performed on the affected energy that is in most frequent clinical
49.9
use at the facility. The remaining energies may be validated with quality control check
49.10
procedures against the criteria in part .............
49.11
4733.0515 PERIODIC QUALITY SPOT CHECKS RADIATION THERAPY
SYSTEMS OF LESS THAN 500 kV.
AF
49.12
T
49.8
Subpart 1. Periodic quality spot checks. Periodic quality spot checks must be
49.14
performed on radiation therapy systems capable of operation at 150 kV or greater. Quality
49.15
spot checks must:
49.16
49.17
49.18
DR
49.13
A. be performed according to written procedures established by a qualified
medical physicist; and
B. follow written procedures that specify:
49.19
(1) the frequency at which tests or measurements are to be performed; and
49.20
(2) that the quality control check is performed during full calibrations.
49.21
Subp. 2. Tolerances. The cause for a parameter exceeding a tolerance set in the
49.22
written procedures established by the qualified medical physicist must be investigated and
49.23
corrected before the therapy system is used for patient irradiation.
4733.0515
49
07/17/15
50.1
REVISOR
SGS/IL
RD3888
Subp. 3. Qualified medical physicist review. The registrant must have the qualified
50.2
medical physicist review and sign the results of each radiation output quality control
50.3
check within one month of test completion.
50.4
50.5
50.6
50.7
Subp. 4. Frequency. The registrant must ensure that periodic quality spot checks are
performed at intervals not to exceed one month.
Subp. 5. Safety checks. Safety checks must be performed at intervals not to exceed
one month and must ensure proper operation of:
A. electrical interlocks at each external beam radiation therapy room entrance;
50.9
B. the "BEAM-ON" and termination switches;
50.10
C. beam condition indicator lights on the access doors, control console, and in
AF
50.11
T
50.8
the radiation therapy room;
D. viewing and audio systems; and
50.13
E. if applicable, electrically operated treatment room doors from inside and
DR
50.12
50.14
outside the treatment room.
50.15
4733.0520 PHOTON (500 kV AND ABOVE) AND ELECTRON-PRODUCING
SYSTEMS (500 keV AND ABOVE).
50.16
50.17
50.18
50.19
Subpart 1. Leakage radiation.
A. Leakage radiation outside the maximum useful beam in photon and electron
modes must meet the following requirements.
(1) The absorbed dose due to leakage radiation, excluding neutrons, at any
50.20
50.21
point outside the maximum-sized useful beam, but within a circular plane of radius two
50.22
meters which is perpendicular to and centered on the central axis of the useful beam, must
50.23
not exceed a maximum of 0.2 percent and an average of 0.1 percent of the absorbed dose
50.24
on the central axis of the beam at the nominal treatment distance, such as the patient plane.
4733.0520
50
07/17/15
REVISOR
SGS/IL
RD3888
51.1
Measurements must be averaged over an area not exceeding 100 square centimeters at a
51.2
minimum of 16 points uniformly distributed in the plane.
(2) Except for the area defined in this subpart, the absorbed dose due
51.3
51.4
to leakage radiation, excluding neutrons, at one meter from the electron path between
51.5
the electron source and the target or electron window must not exceed 0.5 percent of
51.6
the absorbed dose on the central axis of the beam at the nominal treatment distance.
51.7
Measurements must be averaged over an area not exceeding 100 square centimeters.
(3) For each radiation therapy system, the registrant must obtain from the
51.9
manufacturer, or determine, the leakage radiation existing at the positions in this subpart
51.10
for the specified operating conditions.
51.12
B. Leakage radiation through beam-limiting devices must meet the following
requirements.
AF
51.11
T
51.8
(1) All adjustable or interchangeable beam-limiting devices must attenuate
51.13
the useful beam so that, at the nominal treatment distance, the maximum absorbed dose
51.15
anywhere in the area shielded by the beam-limiting devices does not exceed two percent
51.16
of the maximum absorbed dose on the central axis of the useful beam measured in a
51.17
ten-centimeter by ten-centimeter radiation field.
51.18
DR
51.14
(2) All adjustable or interchangeable electron applicators must attenuate
51.19
the radiation. For example, photon radiation generated by electrons incident to the
51.20
beam-limiting device and electron applicator and other parts of the radiation head, must be
51.21
set so that the absorbed dose in a plane perpendicular to the central axis of the useful beam
51.22
at the nominal treatment does not exceed:
(a) a maximum of two percent and average of 0.5 percent of the
51.23
51.24
absorbed dose on the central axis of the useful beam at the nominal treatment distance.
51.25
This limit must apply beyond a line seven centimeters outside the periphery of the useful
51.26
beam; and
4733.0520
51
07/17/15
REVISOR
SGS/IL
RD3888
52.1
(b) a maximum of ten percent of the absorbed dose on the central axis
52.2
of the useful beam at the nominal treatment distance. This limit must apply beyond a line
52.3
two centimeters outside the periphery of the useful beam.
C. Measurement of leakage radiation must meet the following requirements:
52.4
(1) Leakage radiation through the beam-limiting devices must be measured
52.5
with the beam-limiting devices closed and any residual aperture blocked by at least
52.7
two-tenths value layers of suitable absorbing material. In the case of overlapping
52.8
beam-limiting devices, the leakage radiation through each set must be measured
52.9
independently at the depth of maximum dose. Measurements must be made using a
52.10
radiation detector with an area not exceeding ten square centimeters.
AF
T
52.6
(2) Leakage radiation through the electron applicators must be measured
52.11
with the electron beam directed into the air and using a radiation detector with an area up
52.13
to, but not exceeding, one square centimeter suitably protected against radiation that has
52.14
been scattered from material beyond the radiation detector. Measurements must be made
52.15
using one centimeter of water-equivalent buildup material.
52.16
52.17
DR
52.12
Subp. 2. Filters and wedges. Filters and wedges must meet the requirements in
items A to E.
A. Each removable wedge filter must be clearly marked with an identification
52.18
52.19
52.20
52.21
52.22
52.23
number.
B. For removable wedge filters, the nominal wedge angle must appear on the
wedge or, if the wedge filter is permanently mounted to the tray, on the wedge tray.
C. If the wedge or wedge tray is damaged, the wedge transmission factor must
be redetermined.
4733.0520
52
07/17/15
53.1
REVISOR
SGS/IL
RD3888
D. If the absorbed dose rate information required by this subpart is exclusively
53.2
for operating with a field-flattening or beam-scattering filter in place, the filter must be
53.3
removable only by using tools.
53.4
53.5
E. For equipment manufactured after July 9, 1997, which uses a system of wedge
filters, interchangeable field-flattening filters, or interchangeable beam-scattering foils:
(1) irradiation must not be possible until a filter is selected or a decision
53.6
53.7
to use "no filter" has been made at the treatment control panel, either manually or
53.8
automatically;
not in the correct position;
(3) the treatment control panel must have a display that shows the wedge
53.11
53.12
filters are in use; and
AF
53.10
T
(2) an interlock system must prevent irradiation if the filter selected is
53.9
(4) an interlock must prevent irradiation if any filter or beam-scattering foil
53.14
selection operation to be carried out in the treatment room does not agree with the filter or
53.15
beam-scattering foil selection operation to be carried out at the treatment control panel.
53.16
53.17
DR
53.13
Subp. 3. Beam monitoring.
A. For equipment manufactured after July 9, 1997, the registrant must determine
53.18
during acceptance testing, or obtain from the manufacturer, data sufficient to ensure that
53.19
stray x-ray radiation in the useful electron beam, absorbed dose at the surface during x-ray
53.20
irradiation, and stray neutron radiation in the useful x-ray beam complies with this chapter.
53.21
B. All radiation therapy systems operating at 500 kV and above or 500 keV and
53.22
above must have redundant beam-monitoring systems. The sensors for these systems must
53.23
be fixed in the useful beam during treatment to indicate the dose monitor unit rate.
(1) Equipment manufactured on or before July 9, 1997, must have at least
53.24
53.25
one radiation detector that is incorporated into a useful beam-monitoring system.
4733.0520
53
07/17/15
REVISOR
SGS/IL
RD3888
(2) Equipment manufactured after July 9, 1997, must have at least two
54.1
54.2
independently powered integrating dose meters. Alternatively, common elements may be
54.3
used if the production of radiation is terminated upon failure of any common element.
(3) The detector system and its detector must meet the following
54.4
54.5
requirements:
(a) each detector must be removable only with tools and, if moveable,
54.6
54.7
must be interlocked to prevent incorrect positioning;
(b) each detector must form part of a beam-monitoring system from
54.8
which readings in dose monitoring units of the absorbed dose at a reference point can
54.10
be calculated;
AF
(c) each beam-monitoring system must be capable of independently
54.11
54.12
monitoring, interrupting, and terminating irradiation;
(d) for equipment manufactured after July 9, 1997, the design of the
54.15
54.16
DR
54.13
54.14
T
54.9
beam-monitoring system must ensure that the:
i. malfunctioning of one system does not affect the correct
functioning of the other systems; and
ii. failure of either system must terminate irradiation or prevent
54.17
54.18
the initiation of irradiation; and
(e) each beam-monitoring system must have a legible display at the
54.19
54.20
treatment control panel. For equipment manufactured after July 9, 1997, each display must:
54.21
i. retain a reading until intentionally reset;
54.22
ii. have only one scale and no electrical or mechanical scale
54.23
multiplying factors;
4733.0520
54
07/17/15
REVISOR
RD3888
iii. use a design so that the increasing dose is displayed by
55.1
55.2
SGS/IL
increasing numbers; and
iv. in the event of a power failure, the required beam-monitoring
55.3
55.4
information displayed at the control panel at the time of failure can be retrieved in at
55.5
least one system for 20 minutes.
55.6
Subp. 4. Beam symmetry.
55.10
55.11
55.12
55.13
55.14
55.15
55.16
55.17
55.18
55.19
55.20
B. The devices referenced in this subpart must be able to detect field asymmetry
T
55.9
monitor beam symmetry.
greater than ten percent.
AF
55.8
A. Bent-beam linear accelerators must be provided with auxiliary devices to
C. The devices must be configured to terminate irradiation if field asymmetry
cannot be maintained at ten percent or less.
Subp. 5. Selection and display of dose monitor units.
DR
55.7
A. Irradiation must not be possible until a selection of a number of
dose-monitoring units has been made at the treatment console.
B. The control panel must display the preselected number of dose monitor
units until reset manually.
C. After irradiation is terminated, the dosimeter display must be reset before
subsequent treatment can be initiated.
D. For equipment manufactured after July 9, 1997, after radiation is terminated,
55.21
the operator must be required to reset the preselected dose monitor units before starting
55.22
irradiation.
55.23
55.24
Subp. 6. Air kerma rate or absorbed dose rate. For equipment manufactured after
July 9, 1997, a system must display readings so that the air kerma rate or absorbed dose
4733.0520
55
07/17/15
REVISOR
SGS/IL
RD3888
56.1
rate at a reference point can be calculated. The radiation detectors specified in subpart 3
56.2
may form part of this system. In addition:
56.3
56.4
56.5
A. the dose monitor unit rate must be selected and displayed at the treatment
control panel;
B. if the equipment can deliver under any condition, an air kerma rate or
absorbed dose rate at the nominal treatment distance more than twice the maximum value
56.7
specified by the manufacturer, the system must have a device that terminates irradiation
56.8
when the air kerma rate or absorbed dose rate exceeds a value twice the specified
56.9
maximum. The registrant must maintain a record of the dose rate at which the irradiation
56.10
will be terminated;
C. if the equipment can deliver, under any fault conditions, an air kerma rate or
AF
56.11
T
56.6
absorbed dose rate at the nominal treatment distance more than ten times the maximum
56.13
value specified by the manufacturer, it must have a device that prevents the air kerma rate
56.14
or absorbed dose rate anywhere in the radiation field from exceeding twice the specified
56.15
maximum value and to terminate irradiation if the excess absorbed dose at the nominal
56.16
treatment distance exceeds 400 rad (4.0 Gy); and
56.17
DR
56.12
D. for each radiation therapy system, the registrant must determine, or obtain
56.18
from the manufacturer, the maximum values in this subpart for the specified operating
56.19
conditions. The registrant must maintain records of these maximum values at the facility
56.20
for inspection by the commissioner.
56.21
Subp. 7. Termination of irradiation by beam-monitoring system during
56.22
stationary beam therapy. The equipment must allow the operator to terminate the
56.23
irradiation by the beam-monitoring system or systems during stationary beam radiation
56.24
therapy, which requires:
56.25
56.26
A. each primary system must terminate irradiation when the system has detected
the preselected number of dose monitor units;
4733.0520
56
07/17/15
57.1
REVISOR
SGS/IL
RD3888
B. if the equipment's original design included a secondary dose-monitoring
57.2
system, that system must terminate irradiation when the secondary system detects
57.3
radiation of not more than 15 percent or 40 dose monitor units above the preselected
57.4
number of dose monitor units set at the control panel; and
57.5
57.6
C. for equipment manufactured after July 9, 1997, an indicator on the control
panel must show which monitoring system has terminated irradiation.
Subp. 8. Termination of irradiation. Equipment must allow the operator to
57.8
terminate irradiation and equipment movement, or move from an interruption condition
57.9
to termination condition, from the operator's position at the treatment control panel at
57.10
any time.
AF
57.11
T
57.7
Subp. 9. Interruption of irradiation. If a radiation therapy system has an interrupt
mode, interrupting irradiation and equipment movements must be possible from the
57.13
treatment control panel at any time. After an interruption, restarting irradiation by operator
57.14
action without any reselection of operating conditions must be possible. Irradiation and
57.15
equipment movements must be automatically terminated if any change of a preselected
57.16
value is made during an interruption.
57.17
57.18
57.19
57.20
57.21
DR
57.12
Subp. 10. Timers. An irradiation control device must terminate the irradiation
after a preset time interval.
A. The system must have a timer with a display at the treatment control panel.
The timer must have a preset time selector and an elapsed time indicator.
B. The timer must be cumulative so that it activates with an indication of
57.22
"BEAM-ON" and retains its reading after irradiation is interrupted or terminated. After
57.23
irradiation is terminated, and before irradiation can be reinitiated, it must be necessary to
57.24
reset the elapsed time indicator.
4733.0520
57
07/17/15
58.1
58.2
58.3
58.4
58.5
58.6
58.7
REVISOR
SGS/IL
RD3888
C. The timer must terminate irradiation when a preselected time has elapsed if
the dose-monitoring systems have not previously terminated irradiation.
Subp. 11. Selection of radiation type. Equipment capable of both x-ray and electron
therapy must meet the following additional requirements:
A. the radiation type must be selected and displayed at the treatment control
panel before and during irradiation; and
B. an interlock system must ensure:
(1) the equipment can only emit the radiation type that has been selected;
58.9
(2) x-ray irradiation is prevented when electron applicators are fitted,
except to obtain a verification image;
(3) electron irradiation is prevented when accessories specific for x-ray
58.11
58.13
therapy are fitted; and
DR
58.12
AF
58.10
T
58.8
(4) irradiation is prevented if any selected parameters carried out in the
58.14
treatment room do not agree with the selected parameters carried out at the treatment
58.15
control panel.
58.16
58.17
58.18
58.19
58.20
Subp. 12. Selection of energy. Equipment capable of generating radiation beams of
different energies must meet the following requirements:
A. irradiation must not be possible until energy has been selected at the
treatment control panel;
B. the nominal energy value selected must be displayed at the treatment control
58.21
panel until reset manually for the next irradiation. After irradiation is terminated, it must
58.22
be necessary to reset the nominal energy value selected before subsequent treatment
58.23
can be initiated; and
4733.0520
58
07/17/15
59.1
59.2
59.3
REVISOR
SGS/IL
RD3888
C. irradiation must not be possible until the appropriate flattening filter or
scattering foil for the selected energy is in its proper location.
Subp. 13. Stationary and moving beam radiation therapy. Radiation therapy
59.4
systems capable of both stationary beam radiation therapy and moving beam radiation
59.5
therapy must meet the following requirements:
59.6
A. irradiation must not be possible until a selection of stationary beam radiation
59.7
therapy or moving beam radiation therapy has been selected at the treatment control panel;
B. the mode of operation must be displayed at the treatment control panel;
59.9
C. an interlock system must ensure that the equipment can operate only in
59.12
59.13
AF
59.11
the mode that has been selected;
D. an interlock system must terminate irradiation if any selected parameter in the
treatment room does not agree with the selected parameter at the treatment control panel;
E. moving beam radiation therapy must be controlled to obtain the selected
DR
59.10
T
59.8
59.14
relationships between incremental dose monitor units and incremental movement. For
59.15
equipment manufactured after July 9, 1997:
59.16
(1) an interlock system must terminate irradiation if the number of dose
59.17
monitor units delivered in any ten degrees of rotation or 1 cm of linear motion differs by
59.18
more than 20 percent from the selected value;
(2) where angle terminates the irradiation in moving beam radiation
59.19
59.20
therapy, the dose monitor units delivered must differ by less than five percent from the
59.21
dose monitor unit value selected;
(3) an interlock must prevent motion of more than five degrees or 1 cm
59.22
59.23
beyond the selected limits during moving beam radiation therapy;
4733.0520
59
07/17/15
REVISOR
SGS/IL
RD3888
(4) an interlock must require that a selection of direction be made at the
60.1
60.2
treatment control panel in all units that are capable of both clockwise and counterclockwise
60.3
moving beam radiation therapy; and
(5) moving beam radiation therapy must be controlled with both primary
60.4
60.5
position sensors and secondary position sensors to obtain the selected relationships
60.6
between incremental dose monitor units and incremental movement;
60.8
60.9
60.10
F. where the beam monitoring system terminates the irradiation in moving beam
radiation therapy, the termination of radiation must comply with subpart 7; and
G. for equipment manufactured after July 9, 1997, an interlock system must be
T
60.7
provided to terminate irradiation if movement:
(1) occurs during stationary beam radiation therapy; or
60.12
(2) does not start or stop during moving beam radiation therapy unless the
60.14
stop is preplanned.
Subp. 14. Facility design requirements. In addition to shielding adequately to meet
DR
60.13
AF
60.11
60.15
the requirements in parts 4733.0250 to 4733.0260, the facility must have the following
60.16
provisions.
60.17
A. The control panel must:
(1) provide an indicator that shows whether electrical power is available at
60.18
60.19
the control panel and if activation of the radiation is possible;
60.20
(2) indicate whether radiation is being produced; and
60.21
(3) have an access control locking device that prevents unauthorized use
60.22
of the therapy radiation machine.
60.23
B. If the shielding material in any protective barrier requires the presence of a
60.24
beam interceptor to comply with part 4733.0315, interlocks must prevent the production
4733.0520
60
07/17/15
REVISOR
SGS/IL
RD3888
61.1
of radiation, unless the beam interceptor is in place, whenever the useful beam is directed
61.2
at the designated barriers.
C. The radiation therapy room must have at least one emergency power cutoff
61.3
61.4
switch on either side of the primary beam and must terminate all equipment electrical
61.5
power, including radiation and mechanical motion. This switch is in addition to the
61.6
termination switch required by subpart 8. Emergency power cutoff switches must include
61.7
a manual reset so that the therapy equipment cannot be restarted from the unit's control
61.8
console without resetting the emergency cutoff switch.
D. Safety interlocks must be designed so that any defect or component failure in
T
61.9
the safety interlock system prevents or terminates operation of the therapy equipment.
61.11
E. Surveys for residual activity must be conducted on all radiation therapy
AF
61.10
systems that can generate photon and electron energies above ten MV before removing
61.13
or working on radiation therapy system components that may have become activated
61.14
due to photon-neutron production.
61.15
4733.0525 OPERATING AND EMERGENCY PROCEDURES FOR
THERAPEUTIC SYSTEMS OPERATING ABOVE 500 kV.
61.16
61.17
61.18
61.19
61.20
61.21
61.22
61.23
61.24
DR
61.12
In addition to the requirements in part 4733.0210, subpart 4, the procedures must
specify:
A. no individual, other than the patient, may be in the treatment room during
treatment or during any irradiation for testing or calibration purposes;
B. that the position and shape of the radiation field must be indicated by a light
field when adjustable beam-limiting devices are used; and
C. if a patient is immobilized during treatment, that mechanical supporting or
restraining devices must be used.
4733.0525
61
07/17/15
62.1
62.2
62.3
REVISOR
SGS/IL
RD3888
4733.0530 FULL CALIBRATION MEASUREMENTS FOR RADIATION
THERAPY SYSTEMS OPERATING ABOVE 500 kV.
Subpart 1. Frequency. Full system calibration must be performed by, or under the
62.4
direct supervision of, a qualified medical physicist. Before use, full system calibration
62.5
must be performed:
62.6
A. following installation or reinstallation;
62.7
B. following any change that would alter the calibration or other characteristic
62.9
of the therapy beam;
C. whenever quality control check measurements indicate that the radiation
T
62.8
output differs by more than five percent from the value obtained at the last full calibration
62.11
and the difference cannot be reconciled; and
AF
62.10
D. at intervals not to exceed 12 months. The registrant may conduct individual
62.13
elements of a full calibration at different times provided all parameters for all energies are
62.14
completed at intervals not to exceed 12 months.
62.15
62.16
DR
62.12
Subp. 2. Acceptance testing, commissioning, and full calibration.
A. Acceptance testing, commissioning, and full calibration of radiation therapy
62.17
systems required under this part must be performed by, or under the direct supervision
62.18
of, a qualified medical physicist.
62.19
B. Before the first use following installation or reinstallation of the radiation
62.20
therapy system, acceptance testing and commissioning must be performed in accordance
62.21
with "AAPM Code of Practice for Radiotherapy Accelerators: AAPM Report No. 47,"
62.22
prepared by Radiation Therapy Task Group 45 and the manufacturer's specifications,
62.23
unless a qualified medical physicist determines and documents that a specific
62.24
recommendation of these reports is not warranted.
4733.0530
62
07/17/15
REVISOR
SGS/IL
RD3888
63.1
C. The registrant must establish, document, and implement full calibration
63.2
procedures developed by a qualified medical physicist. Full calibration must include
63.3
measurement of all applicable elements required by Table II of "Comprehensive QA
63.4
for Radiation Oncology: Report of AAPM Radiation Therapy; AAPM report No. 46,"
63.5
prepared by Committee Task Group 40 and must be performed in accordance with "AAPM
63.6
Code of Practice for Radiotherapy Accelerators: AAPM Report No. 47," prepared by
63.7
Radiation Therapy Task Group 45 unless a qualified medical physicist determines and
63.8
documents that a specific recommendation of these reports is not warranted.
63.9
D. For radiation therapy systems that include asymmetric jaws, multileaf
collimation, or dynamic/virtual wedges, a qualified medical physicist must establish,
63.11
document, and implement a calibration protocol. Protocol must include recommendations
63.12
listed in "Quality Assurance of Medical Accelerators," prepared by AAPM Task Group
63.13
142 unless a qualified medical physicist determines and documents that a specific
63.14
recommendation of this report is not warranted.
AF
DR
63.15
T
63.10
E. For linear accelerator-based robotic stereotactic radiosurgery systems, a
63.16
qualified medical physicist must establish, document, and implement a calibration protocol.
63.17
Protocol must include current recommendations listed in "Quality Assurance for robotic
63.18
radiosurgery" prepared by AAPM Task Group 135 unless a qualified medical physicist
63.19
determines and documents that a specific recommendation of this report is not warranted.
63.20
F. For tomotherapy systems a qualified medical physicist must establish,
63.21
document, and implement a calibration protocol. Protocol must include current
63.22
recommendations listed in "Quality Assurance of helical tomotherapy," prepared by
63.23
AAPM Task Group 148 unless a qualified medical physicist determines and documents
63.24
that a specific recommendation of this report is not warranted.
63.25
Subp. 3. Exception. Notwithstanding the requirements of this subpart:
4733.0530
63
07/17/15
64.1
REVISOR
SGS/IL
RD3888
A. full calibration of radiation therapy systems with multi-energy or multimode
64.2
capabilities, or both, is required only for those modes or energies that are not within
64.3
the acceptable range; and
B. if the repair, replacement, or modification does not affect all modes or
64.5
energies, full calibrations must be performed on the affected energy or mode that is
64.6
clinically used most frequently at the facility. The remaining energies or modes may be
64.7
validated with quality control check procedures against the criteria in this part.
64.8
4733.0535 PERIODIC QUALITY SPOT CHECKS FOR RADIATION THERAPY
SYSTEMS OPERATING ABOVE 500 kV.
64.10
64.11
Subpart 1. Spot checks.
AF
64.9
T
64.4
A. The registrant must establish, document, and implement spot check
procedures developed by a qualified medical physicist. Spot checks must be performed at
64.13
intervals and within the tolerances not to exceed those specified in either "Comprehensive
64.14
QA for Radiation Oncology: Report of AAPM Radiation Therapy; AAPM report No. 46,"
64.15
prepared by Committee Task Group 40 or "Task Group 142 report: Quality Assurance of
64.16
medical accelerators" unless a qualified medical physicist determines and documents that
64.17
a specific recommendation of these reports is not warranted.
64.18
DR
64.12
B. Registrants using IMRT:
(1) must establish, document, and implement spot check procedures
64.19
64.20
developed by a qualified medical physicist in accordance with "Guidance document on
64.21
delivery, treatment, planning, and clinical implementation for IMRT: Report of IMRT
64.22
subcommittee of the AAPM radiation therapy committee: AAPM Report No. 82," unless
64.23
a qualified medical physicist determines and documents that a specific recommendation
64.24
of this report is not warranted;
4733.0535
64
07/17/15
REVISOR
SGS/IL
RD3888
(2) must include commissioning and testing of the treatment planning and
65.1
65.2
delivery systems, routine quality assurance of the delivery system, and patient-specific
65.3
validation of treatment plans; and
(3) must also be in accordance with the manufacturer's contractual
65.4
65.5
65.6
specifications.
C. Registrants using linear accelerator-based robotic stereotactic radiosurgery,
must establish, document, and implement spot check procedures developed by a qualified
65.8
medical physicist in accordance with "Report of AAPM TG 135: Quality assurance for
65.9
robotic radiosurgery" unless a qualified medical physicist determines and documents that
65.10
a specific recommendation of this report is not warranted. Spot checks must also be in
65.11
accordance with the manufacturer's contractual specifications.
AF
65.12
T
65.7
D. Registrants using helical tomotherapy must establish, document, and
implement spot check procedures developed by a qualified medical physicist in accordance
65.14
with "Quality assurance for tomotherapy: Report of the AAPM Task Group 148" unless
65.15
a qualified medical physicist determines and documents that a specific recommendation
65.16
of this report is not warranted. Spot checks must also be in accordance with the
65.17
manufacturer's contractual specifications.
65.18
65.19
65.20
DR
65.13
Subp. 2. Tolerances.
A. The registrant must review the results of each periodic radiation output
check according to the following procedures:
65.21
(1) the registrant and qualified medical physicist must be immediately
65.22
notified if any parameter is not within its acceptable tolerance. The radiation therapy
65.23
system may not be made available for subsequent use until the qualified medical physicist
65.24
has determined that all parameters are within their acceptable tolerances;
4733.0535
65
07/17/15
REVISOR
SGS/IL
RD3888
(2) if all quality control check parameters appear to be within their
66.1
66.2
acceptable range, the quality control check must be reviewed and signed by either the
66.3
registrant or qualified medical physicist within seven working days; and
(3) the qualified medical physicist must review and sign the results of each
66.4
66.6
66.7
66.8
66.9
radiation output quality control check within 30 working days of completion.
B. The registrant must promptly repair any system identified in this part that
is not operating properly.
Subp. 3. Safety checks. To satisfy the requirement of this subpart, safety checks
performed at intervals not to exceed one week, must ensure proper operation of:
T
66.5
A. electrical interlocks at each external beam radiation therapy room entrance;
66.11
B. the "BEAM-ON," interrupt, and termination switches;
66.12
C. beam condition indicator lights on the access doors, control console, and in
66.14
66.15
66.16
66.17
the radiation therapy room;
D. viewing and audio systems; and
DR
66.13
AF
66.10
E. electrically operated treatment room doors from inside and outside the
treatment room.
Subp. 4. Emergency cutoff switches. Emergency power cutoff switches must be
66.18
checked for proper operation at installation and any time there is a modification or repair
66.19
of the emergency switch circuit.
66.20
66.21
4733.0600 STEREOTACTIC RADIOSURGERY/STEREOTACTIC BODY
RADIOTHERAPY.
66.22
In addition to the requirements in parts 4731.0520 to 4731.0535, registrants
66.23
performing stereotactic radiosurgery or stereotactic body radiotherapy must follow
66.24
the safety and quality assurance guidelines in AAPM Task Group 101 Report and the
66.25
American Society for Radiation Oncology (ASTRO) report on "Quality and Safety
4733.0600
66
07/17/15
REVISOR
SGS/IL
RD3888
67.1
Consideration in Stereotactic Radiosurgery and Stereotactic Body Radiation Therapy,"
67.2
unless the qualified medical physicist determines and documents that a specific
67.3
recommendation of these reports is not warranted.
67.4
4733.0800 ELECTRONIC BRACHYTHERAPY SYSTEMS.
67.5
Subpart 1. Applicability. Electronic brachytherapy systems are subject to the
67.6
requirements of applicable parts of this chapter and are exempt from parts 4733.0500
67.7
to 4733.0510.
67.9
67.10
A. An electronic brachytherapy device that does not meet the requirements of
part 4733.0800 must not be used for patient use.
T
67.8
B. An electronic brachytherapy device must only be utilized for human use
applications specifically approved by the United States Food and Drug Administration
67.12
(FDA) unless participating in a research study approved by the registrant's Institutional
67.13
Review Board (IRB).
67.15
67.16
67.17
Subp. 2. Registrant's responsibilities for electronic brachytherapy systems. In
DR
67.14
AF
67.11
addition to the requirements in subpart 1, the registrant must:
A. monitor individuals according to part 4733.0320, if applicable;
B. allow only qualified medical personnel trained in safe use of the electronic
67.18
brachytherapy system, including the manufacturer's device-specific training to deliver
67.19
the treatment;
67.20
C. possess survey instruments capable of measuring dose rates over the range
67.21
1 mrem (10 µSv) per hour to 1,000 mrem (10 mSv). The survey instruments must be
67.22
operable and calibrated according to part 4733.0440;
67.23
67.24
D. maintain a copy of the current operating and emergency procedures at the
control console; and
4733.0800
67
07/17/15
68.1
68.2
68.3
REVISOR
SGS/IL
RD3888
E. prevent simultaneous operation of more than one radiation therapy system in
a treatment room, if applicable.
Subp. 3. Facility design requirements. In addition to applicable shielding and
68.4
facility design requirements in parts 4733.0250 to 4733.0275, the treatment room must
68.5
meet the following design requirements:
68.6
A. access to the treatment room must be controlled by a door at each entrance;
68.7
B. the electronic brachytherapy system must not be used for patient irradiation
68.9
unless the operator can maintain continuous observation of the patient;
C. for electronic brachytherapy systems operating below 150 kV, radiation
T
68.8
shielding for the staff in the treatment room must be available, either as a portable shield
68.11
or as localized shielding material around the treatment site;
AF
68.10
D. for electronic brachytherapy systems operating at greater than 150 kV:
68.13
(1) the control panel must be located outside the treatment room; and
68.14
68.15
68.16
DR
68.12
(2) electrical interlocks at all doors must:
(a) prevent the operator from initiating the treatment cycle unless each
treatment room entrance door is closed;
(b) cause the x-ray tube to be shielded when an entrance door is
68.17
68.18
opened; and
(c) prevent the x-ray tube from being exposed following an interlock
68.19
68.20
interruption until all treatment room entrance doors are closed and the x-ray tube on-off
68.21
control is reset at the console;
68.22
68.23
E. electrical safety for electronic brachytherapy systems must meet the
following conditions:
4733.0800
68
07/17/15
REVISOR
SGS/IL
RD3888
(1) the high voltage transformer must be electrically isolated to prevent
69.1
69.2
electrical and magnetic interference with the surrounding environment and ancillary
69.3
equipment;
(2) the high voltage transformer must be isolated from the operator and the
69.4
69.5
environment by a protective housing that requires special tools to open or with electrical
69.6
interlocks to prevent operation while open;
(3) the high voltage transformer must have appropriate safety labels
69.7
69.8
warning personnel of potential electrical shock and heat-related injuries; and
(4) equipment must be in compliance with the most current revision of the
69.9
following International Electrotechnical Commission (IEC) documents:
T
69.10
(a) IEC 60601-1:1998+A1+A2:1995;
69.12
(b) IEC 60601-1-2:2001;
69.13
(c) IEC 60601-2-8:1999; and
69.14
(d) IEC 60601-2-17:2004;
69.16
69.17
69.18
DR
69.15
AF
69.11
F. the control panel, in addition to the displays required by other provisions
in this part, must:
(1) indicate whether electrical power is available at the control panel and if
activating the electronic brachytherapy x-ray tube is possible;
69.19
(2) indicate whether x-rays are being produced;
69.20
(3) indicate electronic brachytherapy x-ray tube potential and current;
69.21
(4) provide a means to terminate an exposure at any time; and
69.22
(5) include a locking device that will prevent unauthorized use of the
69.23
69.24
electronic brachytherapy system;
G. an irradiation timer must:
4733.0800
69
07/17/15
REVISOR
on a dosimeter-based monitor;
(2) be located at the treatment control panel and indicate planned setting
70.3
70.4
RD3888
(1) terminate the irradiation after a preset time interval or integrated charge
70.1
70.2
SGS/IL
and the time elapsed or remaining time;
(3) operate by a cumulative device that activates with an indication of
70.5
70.6
"BEAM-ON" and retains its reading after irradiation is interrupted or terminated. After
70.7
irradiation is terminated and before irradiation can be restarted, it must be necessary to
70.8
reset the elapsed time indicator;
(4) terminate irradiation when a preselected time has elapsed, if any
70.10
T
70.9
dose-monitoring system has not previously terminated irradiation;
(5) permit setting of exposure times as short as 0.1 second;
70.12
(6) not operate if the exposure is set at zero; and
70.13
(7) be accurate to within one percent of the selected value or 0.1 second,
70.15
DR
70.14
AF
70.11
whichever is greater.
Subp. 4. Training. The registrant must permit only trained individuals to operate the
70.16
electronic brachytherapy system. The registrant must provide instruction for individuals
70.17
who operate the electronic brachytherapy system initially as relevant to the individual's
70.18
assigned duties in the operating procedures and must cover:
70.19
A. system-specific radiation safety requirements;
70.20
B. system operation;
70.21
C. clinical uses approved by the FDA;
70.22
D. emergency procedures, including an emergency drill; and
70.23
E. the registrant's quality assurance program.
4733.0800
70
07/17/15
REVISOR
SGS/IL
RD3888
71.1
Subp. 5. Qualified medical physicist support. The registrant must provide the
71.2
services of a qualified medical physicist in facilities having electronic brachytherapy
71.3
systems. The qualified medical physicist is responsible for the electronic brachytherapy
71.4
and must:
71.5
A. evaluate the output from the electronic brachytherapy x-ray tube;
71.6
B. generate the necessary dosimetric information;
71.7
C. supervise and review treatment calculations before initially treating any
71.11
71.12
71.13
71.14
71.15
71.16
71.17
T
71.10
D. establish the appropriate periodic and day-of-use spot checks and review the
data from those checks as required in subpart 10;
E. consult and review with the radiation oncologist or a licensed practitioner
AF
71.9
treatment site;
of the healing arts for the treatment planning, as needed;
F. perform calculation and assessments regarding patient treatments that might
constitute a medical event; and
DR
71.8
G. be physically present when the treatment is initiated and be available during
each patient treatment.
Subp. 6. Operating procedures. The registrant must establish written operating
71.18
procedures for brachytherapy activities that are located at the control console. If the
71.19
control console is integral to the electronic brachytherapy system, the registrant must
71.20
keep the required procedures where the operator is located during the system operation.
71.21
The procedures must require that:
71.22
71.23
71.24
71.25
A. only individuals approved by the registrant, radiation safety officer, or
qualified medical physicist may be present in the treatment room during treatment;
B. electronic brachytherapy systems may not be made available for use unless
the requirements of this chapter have been met;
4733.0800
71
07/17/15
72.1
72.2
72.3
REVISOR
SGS/IL
RD3888
C. the electronic brachytherapy system is inoperable, either by hardware or
password, when unattended by qualified staff or service personnel;
D. the electronic brachytherapy system operator must prevent individuals from
72.4
unshielded exposure by monitoring the position of all individuals in the treatment room
72.5
during operation and all individuals entering the treatment room; and
72.6
72.7
72.8
E. mechanical supporting or restraining devices must be used if a patient must
be held in position during treatment.
Subp. 7. Emergency procedures. The registrant must develop, implement, and
keep written emergency procedures at the control console for responding to an abnormal
72.10
situation. These procedures must include:
72.13
AF
72.12
A. instructions for responding to equipment failures and the names of the
individuals responsible for implementing corrective actions;
B. the names and telephone numbers of the administration, qualified medical
DR
72.11
T
72.9
72.14
physicist, and the radiation safety officer, all of whom must be contacted if the system or
72.15
console operates abnormally; and
72.16
C. instructions for notifying the radiation safety officer and physician if
72.17
the patient's radiation exposure results in a medical emergency, injury, or death and
72.18
instructions for informing the manufacturer and the commissioner of the event.
72.19
72.20
Subp. 8. Safety precaution requirements.
A. A qualified medical physicist and either a radiation oncologist or licensed
72.21
practitioner of the healing arts who are trained in the operation and emergency response
72.22
for the electronic brachytherapy system, must be physically present when all patient
72.23
treatments occur.
4733.0800
72
07/17/15
73.1
REVISOR
SGS/IL
RD3888
B. An operator who has been trained in the operation and emergency response
73.2
for the electronic brachytherapy system must be physically present during the initiation
73.3
and available during patient treatments.
73.4
C. All personnel in the treatment room must remain behind shielding during
73.5
treatment. A qualified medical physicist must approve any deviation from this requirement
73.6
and must designate alternative radiation safety protocols, which must provide equivalent
73.7
protection.
73.8
D. When shielding is required, the registrant must use a survey meter to verify
proper placement of the shielding before the initiation of treatment. Alternatively, a
73.10
qualified medical physicist must designate shielding locations sufficient to meet the
73.11
requirements of parts 4733.0300 to 4733.0315 for any individual, other than the patient, in
73.12
the treatment room.
AF
T
73.9
73.13
Subp. 9. Electronic brachytherapy x-ray tube calibration measurements.
73.14
A. Calibration of the electronic brachytherapy x-ray tube output for an
electronic brachytherapy system must be performed by, or under the direct supervision
73.16
of, a qualified medical physicist.
73.17
73.18
DR
73.15
B. Calibration of the electronic brachytherapy x-ray tube output must be done
for each electronic brachytherapy system:
73.19
(1) after any repair affecting the x-ray beam generation; or
73.20
(2) when indicated by the electronic brachytherapy x-ray tube spot checks.
73.21
73.22
C. Calibrating of the electronic brachytherapy x-ray tube output must include,
as applicable, determining:
(1) the output within two percent of the expected value, if applicable, or
73.23
73.24
determining the output if there is no expected value;
(2) timer accuracy and linearity over the typical range of use;
73.25
4733.0800
73
07/17/15
REVISOR
SGS/IL
RD3888
74.1
(3) backup exposure control devices are operating properly;
74.2
(4) the relative dose distribution about the x-ray tube to within five percent
74.3
of that expected; and
(5) the x-ray tube positioning accuracy to within one millimeter within
74.4
74.5
74.6
the applicator.
D. Calibrating the x-ray tube output required in items A to C must meet current
published recommendations from a recognized national professional association with
74.8
expertise in electronic brachytherapy. In the absence of such a calibration protocol, the
74.9
registrant must follow the manufacturer's calibration procedures.
74.11
E. The registrant must maintain a record of each calibration in an auditable form
for three years. The record must include the:
AF
74.10
T
74.7
(1) calibration date;
74.13
(2) unique identifier for the corresponding electronic brachytherapy source;
74.14
(3) manufacturer, model number, and serial number for the electronic
74.15
74.16
74.17
DR
74.12
brachytherapy system;
(4) model numbers and serial numbers of the instruments used to calibrate
the electronic brachytherapy system; and
(5) name and signature of the qualified medical physicist responsible for
74.18
74.19
74.20
74.21
performing the calibration.
Subp. 10. Periodic and day-of-use spot checks.
A. Spot checks must be performed on each electronic brachytherapy system:
74.22
(1) at the beginning of each day of use;
74.23
(2) each time the system is moved to a new room or site; and
74.24
(3) after each x-ray tube installation.
4733.0800
74
07/17/15
75.1
75.2
75.3
75.4
REVISOR
SGS/IL
RD3888
B. The registrant must perform required periodic spot checks according to
procedures established by a qualified medical physicist.
C. To satisfy the requirements of this subpart, radiation output spot checks must
include, at a minimum:
(1) verification that the output of the electronic brachytherapy x-ray tube
75.5
75.6
falls within three percent of expected values, as appropriate for the system, as determined
75.7
by either the output as a function of time, or the output as a function of the setting on a
75.8
monitor chamber;
(2) verification of the consistency of the dose distribution to within three
75.10
T
75.9
percent of that found during calibration; and
(3) validation of the positioning methods to ensure that the treatment dose
75.13
75.14
75.15
exposes the intended location within one millimeter.
D. The registrant must review the results of each radiation output quality control
check according to the following procedures:
DR
75.12
AF
75.11
(1) a radiation oncologist or licensed practitioner of the healing arts and the
75.16
qualified medical physicist must be notified if any parameter is not within its acceptable
75.17
tolerance. The electronic brachytherapy system must not be made available for subsequent
75.18
use until the qualified medical physicist has determined that all parameters are within
75.19
their acceptable tolerances;
(2) if all radiation output quality control check parameters appear to be
75.20
75.21
within their acceptable range, the quality control check must be reviewed and signed by
75.22
either the oncologist or licensed practitioner of healing arts or qualified medical physicist
75.23
within two days; and
(3) the qualified medical physicist must review and sign the results of each
75.24
75.25
radiation output quality control check at intervals not to exceed 30 days.
4733.0800
75
07/17/15
76.1
76.2
REVISOR
at a minimum, ensure:
(1) proper operation of radiation exposure indicator lights on the electronic
brachytherapy system and on the control console;
(2) proper operation of viewing and intercom systems in each electronic
76.5
76.6
RD3888
E. To satisfy the requirements of this subpart, safety system spot checks must,
76.3
76.4
SGS/IL
brachytherapy facility, if applicable;
(3) proper operation of radiation monitors, if applicable;
76.8
(4) the integrity of all cables, catheters, or parts of the device that carry
high voltages; and
(5) connecting guide tubes, transfer tubes, transfer-tube applicator
76.10
AF
76.9
T
76.7
76.11
interfaces, and treatment spacers are free from any defects that interfere with proper
76.12
operation.
F. If the results of the safety system spot checks required by this part indicate
DR
76.13
76.14
the malfunction of any system, the registrant must secure the control console in the "OFF"
76.15
position and not use the electronic brachytherapy system except as necessary to repair,
76.16
replace, or check the malfunctioning system.
76.17
G. The registrant must maintain a record of each required quality control check in
76.18
an auditable form until the next inspection by the commissioner. The record must include:
76.19
(1) the date of the quality control check;
76.20
(2) the manufacturer, model number, and serial number for the electronic
76.21
brachytherapy system;
(3) the name and signature of the individual who performed the periodic
76.22
76.23
quality control check;
4733.0800
76
07/17/15
REVISOR
the quality control check; and
(5) for radiation output spot checks:
77.3
(a) the unique identifier for the electronic brachytherapy x-ray tube
77.4
77.5
and the manufacturer's name; and
(b) the model number and serial number for the instruments used to
77.6
77.8
77.9
measure the radiation output of the electronic brachytherapy system.
Subp. 11. Acceptance testing for electronic brachytherapy systems.
T
77.7
RD3888
(4) the name and signature of the qualified medical physicist who reviewed
77.1
77.2
SGS/IL
A. The registrant must perform acceptance testing on the treatment planning
system of electronic brachytherapy related computer systems in accordance with the
77.11
current published recommendations from a recognized national professional association
77.12
with expertise in electronic brachytherapy, when available. In the absence of acceptance
77.13
testing protocol published by a national association, the manufacturer's acceptance testing
77.14
protocol must be followed.
77.16
DR
77.15
AF
77.10
B. Acceptance testing must be performed by, or under the direct supervision of,
a qualified medical physicist and must include, as applicable, verification of:
(1) the source-specific input parameters required by the dose calculation
77.17
77.18
algorithm;
(2) the accuracy of dose, dwell time, and treatment time calculations at
77.19
77.20
representative points;
77.21
(3) the accuracy of isodose plots and graphic displays;
77.22
(4) the accuracy of the software used to determine radiation source
77.23
positions from radiographic images; and
4733.0800
77
07/17/15
REVISOR
SGS/IL
RD3888
(5) the accuracy of electronic transfer of the treatment delivery parameters
78.1
78.2
to the treatment delivery unit from the treatment planning system, if the treatment planning
78.3
system is different from the treatment delivery system.
78.4
C. The position indicators in the applicator must be compared to the actual
78.5
position of the source or planned dwell positions, as appropriate, at the time of
78.6
commissioning.
78.7
D. Prior to each patient treatment regimen, the parameters for the treatment
must be evaluated and approved by the licensed practitioner of the healing arts and the
78.9
qualified medical physicist for correctness through means independent of those used
78.10
for the determination of the parameters.
78.11
4733.0805 MOBILE ELECTRONIC BRACHYTHERAPY SERVICE.
78.14
78.15
78.16
78.17
78.18
AF
78.13
In addition to other applicable parts of this chapter, the registrant providing mobile
electronic brachytherapy service must:
A. check all survey instruments before medical use at each address of use or on
DR
78.12
T
78.8
each day of use, whichever is more restrictive;
B. account for the electronic brachytherapy x-ray tube in the electronic
brachytherapy system before departure from the client's address; and
C. perform, at each location on each day of use, all of the required spot checks
78.19
in this part to ensure proper operation of the system.
78.20
4733.0900 SIMULATION SYSTEM REQUIREMENTS.
78.21
Subpart 1. Generally. Equipment and mechanical parameters of any simulation
78.22
system are subject to the same rigorous quality control checks as the treatment unit. The
78.23
various simulator system motions should be as accurate as those of the radiation therapy
78.24
system. In addition, all the elements in the simulator system needed for good image
78.25
quality must be tested, reviewed, and evaluated.
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79.1
79.2
REVISOR
SGS/IL
RD3888
Subp. 2. Equipment performance evaluations.
A. The registrant must establish, document, and implement equipment
79.3
performance procedures, including acceptance testing and periodic verification of system
79.4
performance developed by a service provider qualified according to chapter 4732 or a
79.5
qualified medical physicist; and
79.6
B. for a radiographic simulation system, be performed, at intervals not to
exceed 24 months, in accordance with "Comprehensive QA for Radiation Oncology:
79.8
Report of AAPM Radiation Therapy; AAPM report No. 46," prepared by Committee Task
79.9
Group 40 unless a qualified service provider determines and documents that a specific
79.10
recommendation of these reports is not warranted; or
C. for a computed tomography simulation system, be performed, at intervals not
AF
79.11
T
79.7
to exceed 12 months, in accordance with "Quality assurance for computed tomography
79.13
simulators and the computed tomography-simulation process: Report of the AAPM
79.14
Radiation Therapy committee Task Group No. 66: AAPM Report No. 83" unless a
79.15
qualified medical physicist determines and documents that a specific recommendation
79.16
of these reports is not warranted. A dose index (CTDI) must be completed using a CT
79.17
dosimetry phantom.
79.18
79.19
79.20
79.21
DR
79.12
Subp. 3. Operators. The simulation system must only be operated by a qualified
individual who:
A. is currently registered in radiologic technology or radiation therapy with the
American Registry of Radiologic Technologists, designated ARRT (R) or ARRT (T);
79.22
B. has been trained by the manufacturer or equivalent;
79.23
C. has been trained in appropriate positioning and anatomy for applicable
79.24
procedures; and
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80.2
80.3
80.4
80.5
80.6
80.7
80.8
80.9
SGS/IL
D. has received training regarding the operating and emergency procedures for
the simulation equipment.
Subp. 4. Operating procedures. In addition to the requirements in part 4733.0210,
subpart 4, item C, the procedures must include:
A. a current protocol or technique that specifies the conditions of operation and
the number of images or scans per examination;
B. procedures for personal protective garment use if individuals remain in
the simulation room during exposure; and
C. instructions for using the dosimetry or image quality phantoms, including the
allowable variations for the indicated parameters.
80.11
4733.1100 OPERATORS OF DUAL IMAGING DEVICES.
AF
80.10
80.12
RD3888
T
80.1
REVISOR
Simulation equipment operators may operate a simulation imaging device only if it is
an integral part of the therapy procedures for treatment but are prohibited from operating
80.14
any imaging device for diagnostic purposes unless they have met the requirements in
80.15
Minnesota Statutes, section 144.121, subdivision 5.
DR
80.13
4733.1100
80