Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 289 - RADIATION CONTROL
Subchapter E - REGISTRATION REGULATIONS
Section 289.229 - Radiation Safety Requirements for Accelerators, Therapeutic Radiation Machines, Simulators, and Electronic Brachytherapy Devices
Universal Citation: 25 TX Admin Code ยง 289.229
Current through Reg. 49, No. 38; September 20, 2024
(a) Purpose. This section establishes radiation safety requirements for the use of accelerators, therapeutic radiation machines, radiation therapy simulation systems (simulators), and electronic brachytherapy devices. No person shall possess, use, transfer, or acquire an accelerator, a therapeutic radiation machine, a radiation therapy simulation system (simulator), or electronic brachytherapy device, except as authorized in a certificate of registration issued in accordance with § 289.226 of this title (relating to Registration of Radiation Machine Use and Services) or as otherwise provided for in this chapter.
(b) Scope.
(1) This section applies to persons who
receive, possess, use or transfer accelerators used in industrial operations
and research and development, and therapeutic radiation machines, radiation
therapy simulation systems (simulators), and electronic brachytherapy devices
used in the healing arts and veterinary medicine. Use of therapeutic radiation
machines in the healing arts or veterinary medicine under this section shall be
by or under the supervision of a physician of the healing arts or a
veterinarian. Use of electronic brachytherapy devices under this section shall
be by or under the supervision of a certified physician. The registrant shall
be responsible for the administrative control and for directing the use of the
accelerators, other therapeutic radiation machines, simulators, or electronic
brachytherapy devices.
(2) The
requirements of this section are in addition to and not in substitution for
other applicable requirements of §
289.203
of this title (relating to Notices, Instructions, and Reports to Workers;
Inspections), §
289.204
of this title (relating to Fees for Certificates of Registration, Radioactive
Material Licenses, Emergency Planning and Implementation, and Other Regulatory
Services), §
289.205
of this title (relating to Hearing and Enforcement Procedures), §
289.226
of this title, and §
289.231
of this title (relating to General Provisions and Standards for Protection
Against Machine-Produced Radiation).
(3) Registrants engaged in industrial
radiographic operations are subject to the requirements of §
289.255
of this title (relating to Radiation Safety Requirements and Licensing and
Registration Procedures for Industrial Radiography).
(4) An entity that is a "covered entity" as
that term is defined in HIPAA, (the Health Insurance Portability and
Accountability Act of 1996, 45 Code of Federal Regulations, Parts 160 and 164)
may be subject to privacy standards governing how information that identifies a
patient can be used and disclosed. Failure to follow HIPAA requirements may
result in the department making a referral of a potential violation to the
United States Department of Health and Human Services.
(c) Prohibitions.
(1) The agency may prohibit use of
accelerators, therapeutic radiation machines, simulators, or electronic
brachytherapy devices that pose significant threat or endanger occupational and
public health and safety, in accordance with §
289.205
of this title and §
289.231
of this title.
(2) Individuals
shall not be exposed to the useful beam except for healing arts purposes and
unless such exposure has been authorized by a physician of the healing arts.
For electronic brachytherapy devices, individuals shall not be exposed to the
useful beam except for healing arts purposes and unless such exposure has been
authorized by a certified physician. This provision specifically prohibits
deliberate exposure of an individual for training, demonstration, or other
non-healing arts purposes.
(3) No
research and/or development using radiation machines on humans shall be
conducted unless approved by an Institutional Review Board (IRB) as required by
Title 45, CFR Part 46 and Title 21, CFR Part 56. The IRB shall include at least
one physician of the healing arts to direct any use of radiation in accordance
with §
289.231(b)
of this title.
(d) Exemptions.
(1) Veterinary facilities are
exempt from the aural communication requirements for radiation therapy systems
and radiation therapy simulators in subsection (h)(2)(B)(i), (h)(3)(B)(v), or
(h)(4)(A)(iv) of this section.
(2)
Individuals who are sole physicians, sole operators and the only occupationally
exposed individual are exempt from the following requirements:
(A)
§
289.203(b)
and (c) of this title; and
(B) subsection (h)(1)(G) of this
section.
(e) Definitions. The following words and terms when used in this section shall have the following meaning unless the context clearly indicates otherwise.
(1) Absorbed dose (D)--The mean energy
imparted by ionizing radiation to matter. Absorbed dose is determined as the
quotient of dE by dM, where dE is the mean energy imparted by ionizing
radiation to matter of mass dM. The SI unit of absorbed dose is joule per
kilogram and the special name of the unit of absorbed dose is the gray (Gy).
The previously used special unit of absorbed dose (rad) is being replaced by
the gray.
(2) Absorbed dose
rate--Absorbed dose per unit time, for machines with timers, or dose monitor
unit per unit time for linear accelerators.
(3) Air kerma--The kinetic energy released in
air by ionizing radiation. Kerma is the quotient of dE by dM, where dE is the
sum of the initial kinetic energies of all the charged ionizing particles
liberated by uncharged ionizing particles in air of mass dM. The SI unit of air
kerma is joule per kilogram and the special name for the unit of kerma is the
gray (Gy).
(4) Barrier--(See
definition for protective barrier).
(5) Beam axis--The axis of rotation of the
beam limiting device.
(6)
Beam-flattening filter--(See field-flattening filter).
(7) Beam-limiting device--A field defining
collimator, integral to the therapeutic radiation machine, which provides a
means to restrict the dimensions of the useful beam.
(8) Beam monitoring system--A system designed
and installed in the radiation head to detect and measure the radiation present
in the useful beam.
(9) Beam
quality--A term that describes the penetrating power of the x-ray beam. This is
identified numerically by half-value layer and is influenced by kilovolt peak
(kVp) and filtration.
(10) Beam
quality (accelerator)--A term that describes the type and penetrating power of
the ionizing radiation produced for certain machine settings.
(11) Beam scattering foil--A thin piece of
material (usually metallic) placed in the beam to scatter a beam of electrons
in order to provide a more uniform electron distribution in the useful
beam.
(12) Central axis of the
beam--An imaginary line passing through the center of the useful beam and the
center of the plane figure formed by the edge of the first beam-limiting
device.
(13) Certified physician--A
physician licensed by the Texas Medical Board and certified in radiation
oncology or therapeutic radiology.
(14) Coefficient of variation or C--The ratio
of the standard deviation to the mean value of a population of observations. It
is estimated using the following equation:
(15)
Collimator--A device or mechanism by which the x-ray beam is restricted in
size.
(16) Computed tomography
(CT)--The production of a tomogram by the acquisition and computer processing
of x-ray transmission data.
(17)
Continuous pressure type switch--A switch so constructed that a circuit closing
contact can be maintained only by continuous pressure on the switch by the
operator.
(18) Control panel--The
part of the radiation machine where the switches, knobs, push buttons, and
other hardware necessary for manually setting the technique factors are
located. For purposes of this section console is an equivalent term.
(19) CT conditions of operation--All
selectable parameters governing the operation of a CT x-ray system including,
but not limited to, nominal tomographic section thickness, filtration, and the
technique factors as defined in this subsection.
(20) Detector--(See definition for radiation
detector).
(21) Diaphragm--A device
or mechanism by which the x-ray beam is restricted in size.
(22) Dose monitor unit (DMU)--A unit response
from the beam monitoring system from which the absorbed dose can be
calculated.
(23) Dosimetry
system--A system of devices used for the detection, measurement, and display of
qualitative and quantitative radiation exposures.
(24) Electronic brachytherapy--A method of
radiation therapy using electrically generated x-rays to deliver a radiation
dose at a distance of up to a few centimeters by intracavitary, intraluminal or
interstitial application, or by applications with the source in contact with
the body surface or very close to the body surface.
(25) Electronic brachytherapy device--The
system used to produce and deliver therapeutic radiation including the x-ray
tube, the control mechanism, the cooling system, and the power
source.
(26) Electronic
brachytherapy source--The x-ray tube component used in an electronic
brachytherapy device.
(27) External
beam radiation therapy--Therapeutic irradiation in which the source of
radiation is at a distance from the body.
(28) Field-flattening filter--A filter used
to homogenize the absorbed dose rate over the radiation field.
(29) Field size--The dimensions along the
major axes of an area in a plane perpendicular to the central axis of the beam
at the normal treatment or examination source to image distance and defined by
the intersection of the major axes and the 50% isodose line.
(30) Filter--Material placed in the useful
beam to change beam quality in therapeutic radiation machines subject to
subsection (h) of this section.
(31) Focal spot--The area projected on the
anode of the x-ray tube that is bombarded by the electrons accelerated from the
cathode and from which the useful beam originates.
(32) Gantry--That part of the radiation
therapy system supporting and allowing possible movements of the radiation head
about the center of rotation.
(33)
Gray (Gy)--For purposes of this section, the SI unit of absorbed dose, kerma,
and specific energy imparted equal to 1 joule per kilogram. For purposes of
this section the previous unit of absorbed dose (rad) is being replaced by the
gray (1 Gy = 100 rad).
(34)
Half-value layer (HVL)--The thickness of a specified material which attenuates
x-radiation or gamma radiation to an extent such that the exposure rate (air
kerma rate), or absorbed dose rate is reduced to one-half of the value measured
without the material at the same point.
(35) Healing arts--Any treatment, operation,
diagnosis, prescription, or practice for the ascertainment, cure, relief,
palliation, adjustment, or correction of any human disease, ailment, deformity,
injury, or unhealthy or abnormal physical or mental condition.
(36) Image receptor--Any device, such as a
fluorescent screen or radiographic film, that transforms incident x-ray photons
either into a visible image or into another form that can be made into a
visible image by further transformations.
(37) Institutional Review Board (IRB)--Any
board, committee, or other group formally designated by an institution to
review, approve the initiation of, and conduct periodic review of biomedical
research involving human subjects.
(38) Interlock--A device preventing the start
or continued operation of equipment unless certain predetermined conditions
prevail.
(39) Interruption of
irradiation--The stopping of irradiation with the possibility of continuing
irradiation without resetting of operating conditions at the control
panel.
(40) Irradiation--The
exposure of a living being or matter to ionizing radiation.
(41) Isocenter--The center of the sphere
through which the useful beam axis passes while the gantry moves through its
full range of motions.
(42)
Kilovolt (kV) (kilo electron volt (keV))--The energy equal to that acquired by
a particle with one electron charge in passing through a potential difference
of one thousand volts in a vacuum. (Note: current convention is to use kV for
photons and keV for electrons.)
(43) Kilovolt peak--kVp (See definition for
peak tube potential).
(44) Lead
equivalent--The thickness of lead affording the same attenuation, under
specified conditions, as the material in question.
(45) Leakage radiation--Radiation emanating
from the source(s) assembly except for the useful beam and radiation produced
when the exposure switch or timer is not activated.
(46) Leakage technique factors--The technique
factors associated with the source assembly that is used in measuring leakage
radiation.
(47) Licensed medical
physicist--An individual holding a current Texas license under the Medical
Physics Practice Act, Texas Occupations Code, Chapter 602, with a specialty in
therapeutic radiological physics.
(48) Light field--The area illuminated by
light, simulating the radiation field.
(49) mA--Milliampere.
(50) Medical event--An event that meets the
criteria specified in subsection (i) of this section.
(51) Megavolt (MV) (megaelectron volt
(MeV))--The energy equal to that acquired by a particle with one electron
charge in passing through a potential difference of one million volts in a
vacuum.
(52) Mobile electronic
brachytherapy device--An electronic brachytherapy device that is transported
from one address to be used at another address.
(53) Moving beam radiation therapy--Radiation
therapy with any planned displacement of radiation field or patient relative to
each other, or with any planned change of absorbed dose distribution. It
includes arc, skip, conformal, intensity modulation and rotational
therapy.
(54) Nominal treatment
distance--The following nominal treatment distances shall apply.
(A) For electron irradiation, the distance
from the scattering foil, virtual source, or exit window of the electron beam
to the entrance surface of the irradiated object along the central axis of the
useful beam, as specified by the manufacturer.
(B) For x-ray irradiation, the virtual source
or target to isocenter distance along the central axis of the useful beam to
the isocenter. For non-isocentric equipment, this distance shall be that
specified by the manufacturer.
(55) Output--The exposure rate (air kerma
rate), dose rate, or a quantity related to these rates from a therapeutic
radiation machine.
(56) Peak tube
potential--The maximum value of the potential difference in kilovolts across
the x-ray tube during an exposure.
(57) Phantom--An object behaving in
essentially the same manner as tissue, with respect to absorption or scattering
of the ionizing radiation in question.
(58) Physician--An individual licensed by the
Texas Medical Board.
(59) Port
film--An x-ray exposure made with a radiation therapy system to visualize a
patient's treatment area using radiographic film.
(60) Portable shielding--Moveable shielding
that can be placed in the primary or secondary beam to reduce the radiation
exposure to the patient, occupational worker or a member of the public. The
shielding can be easily moved to position with use of mobility devices or by
hand.
(61) Prescribed dose--The
total dose and dose per fraction as documented in the written directive. The
prescribed dose is an estimation from measured data from a specified
therapeutic machine using assumptions that are clinically acceptable for the
treatment technique and historically consistent with the clinical calculations
previously used for patients treated with the same clinical
technique.
(62) Primary dose
monitoring system--A system that will monitor the useful beam during
irradiation and that will terminate irradiation when a preselected number of
dose monitor units have been delivered.
(63) Primary protective barrier--(See
definition for protective barrier).
(64) Protective apron--An apron made of
radiation absorbing materials used to reduce radiation exposure.
(65) Protective barrier--A barrier of
radiation absorbing materials used to reduce radiation exposure. The types of
protective barriers are as follows:
(A)
primary protective barrier--A barrier sufficient to attenuate the useful beam
to the required degree.
(B)
secondary protective barrier--A barrier sufficient to attenuate the stray
radiation to the required degree.
(66) Protective glove--A glove made of
radiation absorbing materials used to reduce radiation exposure.
(67) Radiation detector--A device which, in
the presence of radiation provides, by either direct or indirect means, a
signal or other indication suitable for use in measuring 1 or more quantities
of incident radiation.
(68)
Radiation field--(See definition for useful beam).
(69) Radiation head--The structure from which
the useful beam emerges.
(70)
Radiation oncologist--A physician with a specialty in radiation
therapy.
(71) Radiation therapy
simulation system (simulator)--An x-ray system intended for localizing and
confirming the volume to be irradiated during radiation treatment and
confirming the position and size of the therapeutic irradiation
field.
(72) Radiation therapy
system--An x-ray system that utilizes prescribed doses of ionizing radiation
for treatment.
(73) Scan--The
complete process of collecting x-ray transmission data for the production of a
tomogram. Data can be collected simultaneously during a single scan for the
production of one or more tomograms.
(74) Scan increment--The amount of relative
displacement of the patient with respect to the CT x-ray system between
successive scans measured along the direction of such displacement.
(75) Scan sequence--A preselected set of 2 or
more scans performed consecutively under preselected CT conditions of
operation.
(76) Scan time--The
period of time between the beginning and end of x-ray transmission data
accumulation for a single scan.
(77) Scattered radiation--Radiation that has
been deviated in direction during passage through matter.
(78) Secondary dose monitoring system--A
system which will terminate irradiation in the event of failure of the primary
dose monitoring system.
(79)
Secondary protective barrier (See definition for protective barrier).
(80) Shutter--A device attached to the tube
housing assembly which can totally intercept the useful beam and which has a
lead equivalency not less than that of the tube housing assembly.
(81) Source-to-skin distance (SSD)--The
distance from the source to the skin of the patient.
(82) Spot check--Those tests and analyses
performed at specified intervals for the purpose of verifying the consistent
output of radiation equipment.
(83)
Stationary beam therapy--Radiation therapy without displacement of one or more
mechanical axes relative to the patient during irradiation.
(84) Supervision--The delegating of the task
of applying radiation in accordance with this section to persons not licensed
in the healing arts or veterinary medicine, who provide services under the
physician's control. The physician or veterinarian assumes full responsibility
for these tasks and shall assure that the tasks will be administered
correctly.
(85) Target--That part
of an x-ray tube or accelerator onto which a beam of accelerated particles is
directed to produce ionizing radiation or other particles.
(86) Termination of irradiation--The stopping
of irradiation in a fashion which will not permit continuance of irradiation
without the resetting of operating conditions at the control panel.
(87) Therapeutic radiation machine--X ray or
electron producing equipment designed and used for external beam radiation
therapy.
(88) Traceable to a
national standard--This indicates that a quantity or a measurement has been
compared to a national standard, for example, National Institute of Standards
and Technology, directly or indirectly through one or more intermediate steps
and that all comparisons have been documented.
(89) Tube housing assembly--The tube housing
with tube installed. It includes high-voltage and/or filament transformers and
other appropriate elements when such are contained within the tube
housing.
(90) Useful
beam--Radiation that passes through the window, aperture, cone, or other
collimating device of the source housing. Also referred to as the primary
beam.
(91) Veterinarian--An
individual licensed by the Texas Board of Veterinary Medical
Examiners.
(92) Virtual source--A
point from which radiation appears to originate.
(93) Wedge filter--An added filter effecting
continuous progressive attenuation on all or part of the useful beam.
(94) Written directive--An order in writing
for the administration of radiation to a specific patient as specified in
subsection (h)(1)(F)(ii) of this section.
(f) Accelerators used for research and development and industrial operations.
(1)
Registration. Each person possessing an accelerator for non-human use, shall
apply for and receive a certificate of registration from the agency before
beginning use of the accelerator. A person may energize the accelerator for
purposes of installation and acceptance testing before receiving a certificate
of registration from the agency in accordance with §
289.226(i)(1)
of this title.
(2) Facility
requirements.
(A) Each accelerator facility
shall be provided with primary and/or secondary barriers as are necessary to
assure compliance with §
289.231(m)
and (o) of this title.
(B) A radiation survey shall be conducted
when the accelerator is registered and is capable of producing radiation to
determine compliance with §
289.231(m)
and (o) of this title.
(C) Initial surveys shall be performed as
follows.
(i) All new and existing facilities
not previously surveyed shall have a survey made by, or under the direction of,
the registrant.
(ii) A survey
report shall be made and shall include, but not be limited to, the following:
(I) a diagram of the facility that details
building structures and the position of the accelerator, control panel, and
associated equipment;
(II) a
description of the accelerator including the manufacturer, model and serial
number, beam type, and beam energy;
(III) a description of the instrumentation
used to determine radiation measurements, including the date and source of the
most recent calibration for each instrument used;
(IV) conditions under which radiation
measurements were taken; and
(V)
survey data including:
(-a-) projected annual
total effective dose equivalent (TEDE) in areas adjacent to the accelerator;
and
(-b-) a description of
workload, use, and occupancy factors employed in determining the projected
annual TEDE.
(iii) The registrant shall maintain a copy of
the initial survey report for inspection by the agency in accordance with
subsection (l) of this section.
(iv) The survey report shall include
documentation of all instances where the facility is in violation of applicable
requirements of this chapter. Any deficiencies detected during the survey shall
be corrected prior to using the accelerator.
(3) Safety requirements.
(A) Interlock systems shall comply with the
following requirements.
(i) Instrumentation,
readouts, and controls in the accelerator console shall be clearly
identified.
(ii) Each entrance into
a target room or other high radiation area shall be provided with a safety
interlock that shuts down the machine under conditions of barrier
penetration.
(iii) When the
production of radiation has been interrupted, it shall only be possible to
resume operation of the accelerator by manually resetting the
console.
(iv) Each safety interlock
shall be on an electrical circuit that allows the interlock to operate
independently of all other safety interlocks.
(v) All safety interlocks shall be designed
so that any defect or component failure in the interlock system prevents
operation of the accelerator.
(vi)
A scram button or other emergency power cut-off switches shall be labeled. The
scram button or cut-off switches shall include a manual reset so that the
accelerator cannot be restarted from the accelerator console without resetting
the cut-off switch.
(vii) The
safety interlock system shall have a visible or audible alarm that will
indicate when any interlock has been activated.
(viii) All interlocks and visible or audible
alarms shall be tested for proper operation at intervals not to exceed three
months.
(ix) If an interlock or
alarm is operating improperly, it shall be immediately labeled as defective and
repaired within 7 calendar days.
(x) Records of tests and repairs required by
this paragraph shall be made and maintained in accordance with subsection (l)
of this section for inspection by the agency.
(B) Each registrant shall develop and
implement written operating and safety procedures. The procedures may be
documented in an electronic reporting system and shall include, but not be
limited to, the following:
(i) methods used to
secure the accelerator from unauthorized use;
(ii) methods of testing and training
operators in accordance with paragraph (4) of this subsection;
(iii) procedures for notifying the proper
personnel in the event of an accident;
(iv) posting requirements;
(v) procedures for testing interlocks,
entrance controls, and alarm systems;
(vi) personnel monitoring;
(vii) maintenance of records; and
(viii) procedures for necessary area surveys
and time intervals.
(C)
The registrant shall ensure that radiation measurements are performed with a
calibrated dosimetry system. The dosimetry system calibration shall be
traceable to a national standard. The calibration interval shall not exceed 24
months. There shall be available at each accelerator facility, appropriate
portable monitoring equipment that is operable and has been calibrated for the
appropriate radiations being produced at the facility.
(D) A radiation protection survey shall be
performed and the results recorded when changes have been made in shielding,
operation, equipment, or occupancy of adjacent areas.
(E) For portable or mobile accelerators, such
as neutron generators that are used at temporary job sites where permanent
shielding is not available, radiation protection shall be provided by temporary
shielding or by providing an adequate exclusion area around the accelerator
while it is in use.
(F) Records of
calibration and survey results made in accordance with subparagraphs (C) and
(D) of this paragraph shall be maintained in accordance with subsection (l) of
this section.
(G) The registrant
shall perform radiation surveys and contamination smears prior to the transfer
or disposal of an accelerator operating at or above 10 MeV. Such survey(s)
shall be documented and maintained by the registrant for inspection by the
agency in accordance with subsection (l) of this section.
(H) The registrant shall retain records of
receipt, transfer, and disposal of all radiation machines specific to each
authorized use location. The records shall include the date, manufacturer name,
model and serial number from the control panel or console of the radiation
machine and identification of the person making the record.
(4) Training requirements for
operators.
(A) No person shall be permitted
to operate an accelerator unless such person has received instruction in and
demonstrated competence with the following:
(i) operating and safety procedures in
accordance with paragraph (3)(B) of this subsection;
(ii) radiation warning and safety devices
incorporated into the equipment and in the room;
(iii) identification of radiation hazards
associated with the use of the equipment; and
(iv) procedures for reporting an actual or
suspected exposure.
(B)
Records of the training specified in subparagraph (A) of this paragraph shall
be made and maintained for agency inspection in accordance with subsection (l)
of this section.
(g) Requirements for accelerator(s) used in industrial radiography. In addition to the requirements in subsections (f)(1), (2), and (3)(C) - (H) of this section, accelerators used for industrial radiography shall meet the applicable requirements of § 289.255 of this title.
(h) Therapeutic radiation machines, simulators used in the healing arts, veterinary medicine, and electronic brachytherapy devices.
(1)
General requirements.
(A) Each person
possessing a therapeutic radiation machine capable of operating at or above 1
million electron volts (MeV) shall apply for and receive a certificate of
registration from the agency before using the accelerator for human use. A
person may energize the accelerator for purposes of installation and acceptance
testing before receiving a certificate of registration from the
agency.
(B) Each person possessing
a simulator, a therapeutic radiation machine capable of operating below 1 MeV,
and/or an electronic brachytherapy device, shall apply for a certificate of
registration within 30 days after energizing the equipment.
(C) Individuals who operate radiation
machines for human use shall meet the appropriate credentialing requirements
issued in accordance with the Medical Radiologic Technologist Certification
Act, Texas Occupations Code, Chapter 601. Copies of the credentialing document
shall be maintained at the locations(s) where the individual is
working.
(D) The electronic
brachytherapy registrant shall require the physician to be:
(i) licensed by the Texas Medical Board;
and
(ii) certified in:
(I) radiation oncology or therapeutic
radiology by the American Board of Radiology; or
(II) radiation oncology by the American
Osteopathic Board of Radiology;
(E) Operators of the electronic brachytherapy
device shall complete device-specific training as follows:
(i) completion of a training program provided
by the manufacturer; or
(ii)
training received that is substantially equivalent to the manufacturer's
training program from a certified physician or a licensed medical physicist who
is trained to use the device.
(iii)
The registrant shall retain a record of each individual's device-specific
training in accordance with subsection (l) of this section for inspection by
the agency.
(F) Each
facility, including facilities using electronic brachytherapy devices, shall
develop a quality assurance program in writing or in an electronic reporting
system. The quality assurance program shall be implemented as a method of
minimizing deviations from facility procedures and to document preventative
measures taken prior to serious patient injury or therapeutic
misadministration.
(i) The quality assurance
program shall include but not be limited to the following topics:
(I) treatment planning and patient
simulation;
(II) charting and
documenting treatment field parameters;
(III) dose calculation and review
procedures;
(IV) review of daily
treatment records; and
(V) for
electronic brachytherapy, verification of catheter placement and device
exchange procedures;
(ii) A written directive shall be prepared
prior to administration of a therapeutic radiation dose except where a delay to
provide a written directive would jeopardize the patient's health. The
information contained in the oral directive shall be documented immediately in
the patient's record and a written directive prepared within 24 hours of the
oral directive.
(iii) A written
directive that changes an existing written directive for any therapeutic
radiation procedure is only acceptable if the revision is dated and signed by a
certified physician prior to the administration of the therapeutic dose, or the
next fractional dose.
(iv)
Deviations from the prescribed treatment, from the facilities quality assurance
program, and from the operating and safety procedures shall be investigated and
brought to the attention of the certified physician or licensed medical
physicist, and the radiation safety officer (RSO).
(v) The patient's identity shall be verified
by more than one method as the individual named in the written directive prior
to administration.
(vi) The
discovery of each medical event or misadministration shall be reported in
accordance with subsection (i) or (j) of this section.
(vii) The review of the quality assurance
program shall include all the deviations from the prescribed treatment and
shall be conducted at intervals not to exceed 14 months. A signed record of
each dated review shall be maintained for inspection by the agency in
accordance with subsection (l) of this section and shall include evaluations
and findings of the review.
(G) Written operating and safety procedures
shall be developed by a licensed medical physicist with a specialty in
therapeutic radiological physics and shall include any restrictions required
for the safe operation of the particular therapeutic radiation machine. These
procedures shall be available in the control area of the therapeutic radiation
machine and an electronic brachytherapy device. The operator(s) shall be able
to demonstrate familiarity with these procedures. These procedures shall
include, but are not limited to the following:
(i) therapeutic radiation machines shall not
be used for irradiation of patients unless full calibration measurements and
quality assurance checks have been completed;
(ii) therapeutic radiation machines shall not
be used in the administration of radiation therapy if a spot check indicates a
significant change in the operating characteristics of a system as specified in
the written procedures;
(iii)
therapeutic radiation machines shall not be left unattended unless secured by a
locking device which will prevent unauthorized use (A computerized pass-word
system would also constitute a locking device);
(iv) when there is a need to immobilize a
patient or port film for radiation therapy, mechanical supporting or
restraining devices shall be used;
(v) no individual, other than the patient,
shall be in the treatment room during exposures from therapeutic radiation
machines operating above 150 kV;
(vi) at energies less than or equal to 150
kV, any individual, other than the patient, in the treatment room shall be
protected by a barrier sufficient to meet the requirements of §
289.231(m)
and (o) of this title;
(vii) use of a technique chart for simulators
in accordance with paragraph (4)(A)(i) of this subsection;
(viii) radiation dose requirements in
accordance with §
289.231(m)
and (o) of this title;
(ix) personnel monitoring requirements in
accordance with §
289.231(n)
of this title;
(x) use of
protective devices for simulators in accordance with paragraph (4)(A)(iii) of
this subsection;
(xi) credentialing
requirements for individuals operating radiation machines in accordance with
subparagraph (C) of this paragraph;
(xii) film processing program for simulators
in accordance with paragraph (4)(A)(viii) of this subsection; and
(xiii) procedures for restriction and
alignment of beam for simulators in accordance with paragraph (4)(B)(iii) of
this subsection.
(H)
Registrants with equipment that has been issued variances by the United States
Food and Drug Administration (FDA) to Title 21, CFR Part 1020 shall maintain
copies of those variances at authorized use locations in accordance with
subsection (l) of this section.
(I)
The registrant shall perform radiation surveys and contamination smears prior
to the transfer or disposal of an accelerator operating at or above 10 MeV.
Such survey(s) shall be documented and maintained by the registrant for
inspection by the agency in accordance with subsection (l) of this
section.
(J) Where applicable, the
licensed medical physicist shall perform acceptance testing on the treatment
planning system of therapy-related computer systems in accordance with
published protocols accepted by nationally recognized bodies. In the absence of
such a published protocol, the manufacturer's current protocol shall be
followed.
(2)
Therapeutic radiation machines capable of operating at energies below 1 MeV.
(A) Equipment requirements.
(i) When the tube is operated at its leakage
technique factors, the leakage radiation shall not exceed the values specified
at the distance stated for the classification of that radiation machine system
shown in the following Table I. The leakage technique factors are the
maximum-rated peak tube potential and the maximum-rated continuous tube current
for the maximum-rated peak tube potential.
(ii)
Permanent fixed diaphragms or cones used for limiting the useful beam shall
provide the same or a higher degree of protection as required for the tube
housing assembly.
(iii) Removable
and adjustable beam-limiting devices shall meet the following requirements.
(I) Removable beam-limiting devices shall,
for the portion of the useful beam to be blocked by these devices, transmit not
more than 1.0% of the useful beam at the maximum kVp and maximum treatment
filter. This requirement does not apply to auxiliary blocks or materials placed
in the x-ray field to shape the useful beam to the individual
patient.
(II) Adjustable
beam-limiting devices installed before March 1, 1989, shall, for the portion of
the x-ray beam to be blocked by these devices, transmit not more than 5.0% of
the useful beam at the maximum kVp and maximum treatment filter.
(III) Adjustable beam-limiting devices
installed after March 1, 1989, shall meet the requirements of subclause (I) of
this clause.
(iv) The
filter system shall be so designed that:
(I)
the filters cannot be accidentally displaced at any possible tube
orientation;
(II) for equipment
installed after March 1, 1989, an interlock system prevents irradiation if the
proper filter is not in place;
(III) the radiation at 5 centimeters (cm)
from the filter insertion slot opening does not exceed 30 roentgens per hour
(R/hr) (300 mGy/hr) under any operating conditions; and
(IV) each filter is marked as to its material
of construction and its thickness. For wedge filters, the wedge angle shall
appear on the wedge or wedge tray.
(v) The tube housing assembly shall be
capable of being immobilized for stationary treatments.
(vi) The tube housing assembly shall be so
marked that it is possible to determine the location of the focal spot to
within 5 millimeters (mm), and such marking shall be readily accessible for use
during calibration procedures.
(vii) Contact therapy tube housing assemblies
shall have a removable shield of at least 0.5 mm lead equivalency at 100 kVp
that can be positioned over the entire useful beam exit port during periods
when the beam is not in use.
(viii)
The timer shall:
(I) have a display provided
at the treatment control panel and a pre-set time selector;
(II) activate with the production of
radiation and retain its reading after irradiation is interrupted. After
irradiation is terminated and before irradiation can be reinitiated, it shall
be necessary to reset the elapsed time indicator to zero;
(III) terminate irradiation when a
pre-selected time has elapsed, if any dose monitoring system present has not
previously terminated irradiation;
(IV) permit selection of exposure times as
short as one second;
(V) not permit
an exposure if set at zero;
(VI)
not activate until the shutter is opened when irradiation is controlled by a
shutter mechanism unless calibration includes a timer factor to compensate for
mechanical lag; and
(VII) be
accurate to within 1.0% of the selected value or 1 second, whichever is
greater.
(ix) The
control panel, in addition to the displays required in clause (viii)(I) of this
subparagraph, shall have the following:
(I)
an indication of whether electrical power is available at the control panel and
if activation of the x-ray tube is possible;
(II) an indication of whether x rays are
being produced;
(III) means for
indicating x-ray tube potential and current;
(IV) means for terminating an exposure at any
time;
(V) a locking device that
will prevent unauthorized use of the therapeutic radiation system (a
computerized pass-word system would also constitute a locking
device);
(VI) for therapeutic
radiation systems manufactured after March 1, 1989, a positive display of
specific filters in the beam; and
(VII) emergency buttons/switches that shall
be clearly labeled as to their functions.
(x) There shall be means of determining
initially the SSD to within 1 cm and of reproducing this measurement to within
2 mm thereafter.
(xi) Unless it is
possible to bring the radiation output to the prescribed exposure parameters
within 5 seconds, the beam shall be attenuated by a shutter having a lead
equivalency not less than that of the tube housing assembly. After the unit is
at operating parameters, the shutter shall be controlled electrically by the
operator from the control panel. An indication of shutter position shall appear
at the control panel.
(xii) Each
therapeutic radiation system equipped with a beryllium or other low-filtration
window shall be clearly labeled as such upon the tube housing assembly and at
the control panel.
(B)
Facility requirements for therapeutic radiation systems capable of operating
above 50 kVp.
(i) Provision shall be made for
two-way aural communication between the patient and the operator at the control
panel.
(ii) Windows, mirrors,
closed-circuit television, or an equivalent system shall be provided to permit
continuous observation of the patient during irradiation and shall be so
located that the operator can observe the patient from the control panel.
(I) Should the viewing system described in
clause (ii) of this subparagraph fail or be inoperative, treatment shall not be
performed with the unit until the system is restored.
(II) In a facility that has a primary viewing
system by electronic means and an alternate viewing system, should both viewing
systems described in clause (ii) of this subparagraph fail or be inoperative,
treatment shall not be performed with the unit until one of the systems is
restored.
(C)
Additional facility requirements for therapeutic radiation systems capable of
operation above 150 kVp.
(i) Each
installation shall be provided with primary and/or secondary barriers as are
necessary to assure compliance with §
289.231(m)
and (o) of this title. All protective
barriers shall be fixed except for entrance doors or beam
interceptors.
(ii) The control
panel shall be located outside the treatment room or in an enclosed booth
inside the room.
(iii) Interlocks
shall be provided such that all entrance doors shall be closed, including doors
to any interior booths, before treatment can be initiated or continued. If the
radiation beam is interrupted by any door opening, it shall not be possible to
restore the machine to operation without closing the door and reinitiating
irradiation by manual action at the control panel. When any door is opened
while the x-ray tube is activated, the exposure at a distance of 1 m from the
source shall be reduced to less than 100 mR/hr (1 mGy/hr).
(D) Surveys, calibrations, and spot checks.
(i) Surveys shall be performed as follows.
(I) All new and existing facilities not
previously surveyed shall have an initial survey made by a licensed medical
physicist with a specialty in therapeutic radiological physics, who shall
provide a written report of the survey to the registrant. Additional surveys
shall be done after any change in the facility, facility design, or equipment
that might cause a significant increase in radiation hazard.
(II) The registrant shall maintain a copy of
the initial survey report and all subsequent survey reports required by
subclause (I) of this clause in accordance with subsection (l) of this section
for inspection by the agency.
(III)
The survey report shall indicate all instances where the installation is in
violation of applicable requirements of this chapter.
(ii) Calibrations shall be performed as
follows.
(I) The calibration of a therapeutic
radiation system shall be performed at intervals not to exceed 1 year and after
any change or replacement of components that could cause a change in the
radiation output. The calibrations shall be such that the dose at a reference
point in a water or plastic phantom can be calculated to within an uncertainty
of 5.0%.
(II) The calibration of
the radiation output of the therapeutic radiation system shall be performed by
a licensed medical physicist with a specialty in therapeutic radiological
physics who is physically present at the facility during such
calibration.
(III) The calibration
of the therapeutic radiation system shall include, but not be limited to, the
following determinations:
(-a-) verification
that the radiation therapy system is operating in compliance with the design
specifications;
(-b-) HVL for each
kV setting and filter combination used;
(-c-) the exposure rates (air kerma rates) as
a function of field size, technique factors, filter, and treatment distance
used; and
(-d-) the degree of
congruence between the radiation field and the field indicated by the
localizing device, if such device is present, which shall be within 5 mm for
any field edge.
(IV)
Calibration of the radiation output of a therapeutic radiation system shall be
performed with a calibrated dosimetry system. The dosimetry system calibration
shall be traceable to a national standard. The calibration interval shall not
exceed 24 months.
(V) Records of
calibration measurements specified in clause (ii) of this subparagraph shall be
maintained by the registrant in accordance with subsection (l) of this section
for inspection by the agency.
(VI)
A copy of the latest calibrated absorbed dose rate measured on a particular
therapeutic radiation system shall be available at a designated area within the
therapy facility housing that therapeutic radiation system.
(iii) Spot checks shall be
performed on therapeutic radiation systems capable of operation at greater than
150 kVp. Such measurements shall meet the following requirements.
(I) The spot check procedures shall be in
writing, or documented in an electronic reporting system, and shall have been
developed by a licensed medical physicist with a specialty in therapeutic
radiological physics.
(II) If a
licensed medical physicist does not perform the spot check measurements, the
results of the spot check measurements shall be reviewed by a licensed medical
physicist with a specialty in therapeutic radiological physics within 5
treatment days and a record made of the review. If the output varies by more
than 5.0% from the expected value, a licensed medical physicist with a
specialty in therapeutic radiological physics shall be notified
immediately.
(III) The written spot
check procedures shall specify the frequency that tests or measurements are to
be performed and that the spot check shall be performed during the calibration
specified in clause (ii) of this subparagraph. The acceptable tolerance for
each parameter measured when compared to the value for that parameter
determined in the calibration specified in clause (ii) of this subparagraph
shall be stated.
(IV) The written
spot check procedures shall include special operating instructions that shall
be carried out whenever a parameter in subclause (III) of this clause exceeds
an acceptable tolerance.
(V)
Whenever a spot check indicates a significant change in the operating
characteristics of a system, as specified in the procedures, the system shall
be recalibrated, as required in clause (ii) of this subparagraph.
(VI) Records of written spot checks and any
necessary corrective actions shall be maintained by the registrant in
accordance with subsection (l) of this section for inspection by the agency. A
copy of the most recent spot check shall be available at a designated area
within the therapy facility housing that therapeutic radiation
system.
(VII) Spot checks shall be
obtained using a system satisfying the requirements of clause (ii)(IV) of this
subparagraph.
(3) Therapeutic radiation machines capable of
operating at energies of 1 MeV and above.
(A)
Equipment requirements.
(i) For operating
conditions producing maximum leakage radiation, the absorbed dose in rads (mGy)
due to leakage radiation, including x rays, electrons, and neutrons, at any
point in a circular plane of 2 m radius centered on and perpendicular to the
central axis of the beam at the isocenter or normal treatment distance and
outside the maximum useful beam size shall not exceed 0.1% of the maximum
absorbed dose in rads (mGy) of the unattenuated useful beam measured at the
point of intersection of the central axis of the beam and the plane surface.
Measurements excluding those for neutrons shall be averaged over an area up to,
but not exceeding, 100 square centimeters (cm2) at
the positions specified. Measurements of the portion of the leakage radiation
dose contributed by neutrons shall be averaged over an area up to, but not
exceeding, 200 cm2. For each system, the registrant
shall determine or obtain from the manufacturer the leakage radiation existing
at the positions specified for the specified operating conditions. Records on
leakage radiation measurements shall be maintained in accordance with
subsection (l) of this section for inspection by the agency.
(ii) Each wedge filter that is removable from
the system shall be clearly marked with an identification number. Documentation
available at the control panel shall contain a description of the filter. The
wedge angle shall appear on the wedge or wedge tray (if permanently mounted to
the tray). If the wedge tray is damaged, the wedge transmission factor shall be
redetermined. Equipment manufactured after March 1, 1989, shall meet the
following requirements.
(I) Irradiation shall
not be possible until a selection of a filter or a positive selection to use
"no filter" has been made at the treatment console, either manually or
automatically.
(II) An interlock
system shall be provided to prevent irradiation if the filter selected is not
in the correct position.
(III) A
display shall be provided at the treatment console showing the beam quality in
use.
(IV) An interlock shall be
provided to prevent irradiation if any filter selection operation carried out
in the treatment room does not agree with the filter selection operation
carried out at the treatment console.
(iii) The registrant shall determine data
sufficient to assure that the following beam quality requirements in tissue
equivalent material are met.
(I) The absorbed
dose resulting from x rays in a useful electron beam at a point on the central
axis of the beam 10 cm greater than the practical range of the electrons shall
not exceed the values stated in the following Table II. Linear interpolation
shall be used for values not stated.
(II)
Compliance with subclause (I) of this clause shall be determined using:
(-a-) a measurement within a tissue
equivalent phantom with the incident surface of the phantom at the normal
treatment distance and normal to the central axis of the beam;
(-b-) a field size of 10 cm by 10 cm;
and
(-c-) a phantom whose
cross-sectional dimensions exceed the measurement radiation field by at least 5
cm and whose depth is sufficient to perform the required measurement.
(III) The absorbed dose at a
surface located at the normal treatment distance, at the point of intersection
of that surface with the central axis of the useful beam during x-ray
irradiation, shall not exceed the limits stated in the following Table III.
Linear interpolation shall be used for values not stated.
(IV)
Compliance with subclause (III) of this clause shall be determined by
measurements made as follows:
(-a-) within a
tissue equivalent phantom using an instrument that will allow extrapolation to
the surface absorbed dose;
(-b-)
using a phantom whose size and placement meet the requirements of subclause
(II) of this clause;
(-c-) after
removal of all beam modifying devices that can be removed without the use of
tools, except for beam scattering or beam-flattening filters; and
(-d-) using the largest field size available
that does not exceed 15 cm by 15 cm.
(iv) All therapeutic radiation systems shall
be provided with radiation detectors in the radiation head. These shall include
the following, as appropriate.
(I) Equipment
manufactured after March 1, 1989, shall be provided with at least 2 independent
radiation detectors. The detectors shall be incorporated into 2 independent
dose monitoring systems.
(II)
Equipment manufactured on or before March 1, 1989, shall be provided with at
least 1 radiation detector. This detector shall be incorporated into a primary
dose monitoring system.
(III) The
detector and the system into which that detector is incorporated shall meet the
following requirements.
(-a-) Each detector
shall be removable only with tools and shall be interlocked to prevent
incorrect positioning.
(-b-) Each
detector shall form part of a dose monitoring system from whose readings in
dose monitor units the absorbed dose at a reference point in the treatment
volume can be calculated.
(-c-)
Each dose monitoring system shall be capable of independently monitoring,
interrupting, and terminating irradiation.
(-d-) For equipment manufactured after March
1, 1989, the design of the dose monitoring systems shall assure that the
malfunctioning of 1 system shall not affect the correct functioning of the
secondary system; and failure of any element common to both systems that could
affect the correct function of both systems shall terminate
irradiation.
(-e-) Each dose
monitoring system shall have a legible display at the treatment console. For
equipment manufactured after March 1, 1989, each display shall:
(-1-) maintain a reading until intentionally
reset to zero;
(-2-) have only one
scale and no scale multiplying factors;
(-3-) utilize a design such that increasing
dose is displayed by increasing numbers and shall be so designed that, in the
event of an overdosage of radiation, the absorbed dose may be accurately
determined; and
(-4-) retain the
dose monitoring information in at least one system for a 15-minute period of
time in the event of a power failure.
(v) In equipment manufactured
after March 1, 1989, inherently capable of producing useful beams with
unintentional asymmetry exceeding 5.0%, the asymmetry of the radiation beam in
two orthogonal directions shall be monitored before the beam passes through the
beam-limiting device. If the difference in dose rate between one region and
another region symmetrically displaced from the central axis of the beam
exceeds 5.0% of the central axis dose rate, indication of this condition shall
be at the console; and if this difference exceeds 10% of the central axis dose
rate, the irradiation shall be terminated.
(vi) Selection and display of dose monitor
units shall meet the following requirements.
(I) Irradiation shall not be possible until a
selection of a number of dose monitor units has been made at the treatment
console.
(II) The preselected
number of dose monitor units shall be displayed at the treatment console until
reset manually for the next irradiation.
(III) After termination of irradiation, it
shall be necessary to reset the dosimeter display to zero before subsequent
treatment can be initiated.
(IV)
For equipment manufactured after March 1, 1989, after termination of
irradiation, it shall be necessary to manually reset the preselected dose
monitor units before irradiation can be initiated.
(vii) Termination of irradiation by the dose
monitoring system or systems during stationary beam therapy shall meet the
following requirements.
(I) Each primary
system shall terminate irradiation when the preselected number of dose monitor
units has been detected by the system.
(II) If original design of the equipment
includes a secondary dose monitoring system, that system shall be capable of
terminating irradiation when not more than 15% or 40 dose monitor units,
whichever is smaller, above the preselected number of dose monitor units set at
the console has been detected by the secondary dose monitoring
system.
(III) For equipment
manufactured after March 1, 1989, a secondary dose monitoring system shall be
present. That system shall be capable of terminating irradiation when not more
than 10% or 25 dose monitoring units, whichever is smaller, above the
preselected number of dose monitor units set at the console has been detected
by the secondary dose monitoring system.
(IV) For equipment manufactured after March
1, 1989, an indicator on the console shall show which dose monitoring system
has terminated irradiation.
(viii) A locking device shall be provided in
the system to prevent unauthorized use of the x-ray system. A computerized
password system would also constitute a locking device.
(ix) It shall be possible to interrupt
irradiation and equipment movements at any time from the operator's position at
the treatment console. Following an interruption, it shall be possible to
restart irradiation by operator action without any reselection of operating
conditions. If any change is made of a preselected value during an
interruption, irradiation and equipment movements shall be automatically
terminated.
(x) It shall be
possible to terminate irradiation and equipment movements or go from an
interruption condition to termination conditions at any time from the
operator's position at the treatment console.
(xi) Timers shall meet the following
requirements.
(I) A timer that has a display
shall be provided at the treatment console. The timer shall have a preset time
selector and an elapsed time indicator.
(II) The timer shall be a cumulative timer
that activates with the production of radiation and retains its reading after
irradiation is interrupted or terminated. After irradiation is terminated and
before irradiation can be reinitiated, it shall be necessary to reset the
elapsed time indicator to zero.
(III) For equipment manufactured after March
1, 1989, after termination of irradiation and before irradiation can be
reinitiated, it shall be necessary to manually reset the preset time
selector.
(IV) The timer shall
terminate irradiation when a preselected time has elapsed if the dose
monitoring systems have not previously terminated irradiation.
(xii) Equipment capable of
producing more than 1 radiation type shall meet the following additional
requirements.
(I) Irradiation shall not be
possible until a selection of radiation type has been made at the treatment
console.
(II) An interlock system
shall be provided to:
(-a-) ensure that the
equipment can emit only the radiation type that has been selected;
(-b-) prevent irradiation if any selected
operations carried out in the treatment room do not agree with the selected
operations carried out at the treatment console;
(-c-) prevent irradiation with x-rays except
to obtain a port film when electron applicators are fitted; and
(-d-) prevent irradiation with electrons when
accessories specific for x-ray therapy are fitted.
(III) The radiation type selected shall be
displayed at the treatment console before and during irradiation.
(xiii) Equipment capable of
generating radiation beams of different energies shall meet the following
requirements.
(I) Irradiation shall not be
possible until a selection of energy has been made at the treatment
console.
(II) An interlock system
shall be provided to prevent irradiation if any selected operations carried out
in the treatment room do not agree with the selected operations carried out at
the treatment console.
(III) The
nominal energy value selected shall be displayed at the treatment console
before and during irradiation.
(xiv) Equipment capable of both stationary
beam therapy and moving beam therapy shall meet the following requirements.
(I) Irradiation shall not be possible until a
selection of stationary beam therapy or moving beam therapy has been made at
the treatment console.
(II) An
interlock system shall be provided to prevent irradiation if any selected
operations carried out in the treatment room do not agree with the selected
operations carried out at the treatment console.
(III) The selection of stationary or moving
beam shall be displayed at the treatment console. An interlock system shall be
provided to ensure that the equipment can only operate in the mode that has
been selected.
(IV) For equipment
manufactured after March 1, 1989, an interlock system shall be provided to
terminate irradiation if movement of the gantry occurs during stationary beam
therapy or stops during moving beam therapy unless such stoppage is a
preplanned function.
(V) Moving
beam therapy shall be controlled to obtain the selected relationships between
incremental dose monitor units and incremental angle of movement.
(-a-) For equipment manufactured after March
1, 1989, an interlock system shall be provided to terminate irradiation if the
number of dose monitor units delivered in any 10 degrees of arc differs by more
than 20% from the selected value.
(-b-) For equipment manufactured after March
1, 1989, where gantry angle terminates the irradiation in arc therapy, the dose
monitor units shall differ by less than 5.0% from the value calculated from the
absorbed dose per unit angle relationship.
(VI) Where the dose monitor system terminates
the irradiation in moving beam therapy, the termination of irradiation shall be
as required by clause (vii) of this subparagraph.
(xv) For equipment manufactured after March
1, 1989, a system shall be provided from whose readings the absorbed dose rate
at a reference point in the treatment volume can be calculated. The radiation
detectors specified in subparagraph (iv) of this paragraph may form part of
this system. In addition, the dose monitor unit rate shall be displayed at the
treatment console. If the equipment can deliver under any conditions an
absorbed dose rate at the normal treatment distance more than twice the maximum
value specified by the manufacturer for any machine parameters utilized, a
device shall be provided that terminates irradiation when the absorbed dose
rate exceeds a value twice the specified maximum. The dose rate at which the
irradiation will be terminated shall be in a record maintained by the
registrant in accordance with subsection (l) of this section for agency
inspection.
(xvi) The registrant
shall determine, or obtain from the manufacturer, the location with reference
to an accessible point on the radiation head of the x-ray target or the virtual
source of x-rays and the electron window or the virtual source of electrons if
the system has electron beam capabilities.
(xvii) Capabilities shall be provided so that
all radiation safety interlocks can be checked for correct
operation.
(B) Facility
and shielding requirements.
(i) Each
installation shall be provided with primary and/or secondary barriers as are
necessary to assure compliance with §
289.231(m)
and (o) of this title.
(ii) All protective barriers shall be fixed
except for entrance doors or beam interceptors.
(iii) The console shall be located outside
the treatment room and all emergency buttons/switches shall be clearly labeled
as to their functions.
(iv)
Windows, mirrors, closed-circuit television, or an equivalent system shall be
provided to permit continuous observation of the patient following positioning
and during irradiation and shall be so located that the operator may observe
the patient from the console.
(I) Should the
viewing system described in clause (iv) of this subparagraph fail or be
inoperative, treatment shall not be performed with the unit until the system is
restored.
(II) In a facility that
has a primary viewing system by electronic means and an alternate viewing
system, should both viewing systems described in clause (iv) of this
subparagraph fail or be inoperative, treatment shall not be performed with the
unit until one of the systems is restored.
(v) Provision shall be made for continuous
two-way aural communication between the patient and the operator at the console
independent of the accelerator. However, where excessive noise levels or
treatment requirements make aural communication impractical, other methods of
communication shall be used. When this is the case, a description of the
alternate method shall be submitted to and approved by the agency.
(vi) Treatment room entrances shall be
provided with a warning light in a readily observable position near the outside
of all access doors to indicate when the useful beam is "on."
(vii) Interlocks shall be provided such that
all entrance doors shall be closed before treatment can be initiated or
continued. If the radiation beam is interrupted by any door opening, it shall
not be possible to restore the machine to operation without closing the door
and reinitiating irradiation by manual action at the console.
(C) Surveys, calibrations, spot
checks, and operational requirements.
(i)
Surveys shall be performed as follows.
(I)
All new and existing facilities not previously surveyed shall have an initial
survey made by a licensed medical physicist with a specialty in therapeutic
radiological physics, who shall provide a written report of the survey to the
registrant. The physicist who performs the survey shall be a person who did not
consult in the design of the therapeutic radiation machine installation and is
not employed by or within any corporation or partnership with the person who
consulted in the design of the installation. In addition, such surveys shall be
done after any change in the facility or equipment that might cause a
significant increase in radiation hazard.
(II) The survey report shall include, but not
be limited to the following:
(-a-) a diagram
of the facility that details building structures and the position of the
console, therapeutic radiation machine, and associated equipment;
(-b-) a description of the therapeutic
radiation system, including the manufacturer, model and serial number, beam
type, and beam energy;
(-c-) a
description of the instrumentation used to determine radiation measurements,
including the date and source of the most recent calibration for each
instrument used;
(-d-) conditions
under which radiation measurements were taken; and
(-e-) survey data including:
(-1-) projected annual TEDE in areas adjacent
to the therapy room; and
(-2-) a
description of workload, use, and occupancy factors employed in determining the
projected annual TEDE.
(III) The
registrant shall maintain a copy of the survey report and a copy of the survey
report shall be provided to the agency within 30 days of completion of the
survey. Records of the survey report shall be maintained in accordance with
subsection (l) of this section for inspection by the agency.
(IV) The survey report shall include
documentation of all instances where the installation is in violation of
applicable regulations. Any deficiencies detected during the survey shall be
corrected prior to using the machine.
(ii) Calibrations of therapeutic
systems shall be performed as follows.
(I)
The calibration of systems subject to this subsection shall be performed in
accordance with an established calibration protocol before the system is first
used for irradiation of a patient and thereafter at time intervals that do not
exceed 12 months and after any change that might significantly alter the
calibration, spatial distribution, or other characteristics of the therapy
beam. The calibration procedures shall be in writing, or documented in an
electronic reporting system, and shall have been developed by a licensed
medical physicist with a specialty in therapeutic radiological physics. The
calibration protocol entitled, "Protocol for Clinical Reference Dosimetry of
High-Energy Photon and Electron Beams," Task Group 51, Radiation Therapy
Committee, American Association of Physicists in Medicine, Medical Physics
26(9): 1847 - 1870, September 1999, would be accepted as an established
protocol. At a minimum, the calibration protocol shall include items in
subclauses (III) - (V) of this clause below.
(II) The calibration shall be performed by a
licensed medical physicist with a specialty in therapeutic radiological physics
who is physically present at the facility during the calibration.
(III) Calibration radiation measurements
required by subclause (I) of this clause shall be performed using a dosimetry
system:
(-a-) having a calibration factor for
cobalt-60 gamma rays traceable to a national standard;
(-b-) that is traceable to a national
standard and at an interval not to exceed 24 months;
(-c-) that has been calibrated in such a
fashion that an uncertainty can be stated for the radiation quantities
monitored by the system; and
(-d-)
that has had constancy checks performed on the system as specified by the
licensed medical physicist with a specialty in therapeutic radiological
physics.
(IV)
Calibrations shall be in sufficient detail that the dose at a reference point
in a tissue equivalent phantom can be calculated to within an uncertainty of
5.0%.
(V) The calibration of the
therapy unit shall include, but not be limited to, the following
determinations.
(-a-) Verification that the
equipment is operating in compliance with the design specifications concerning
the light field, patient positioning lasers, and back-pointer lights with the
isocenter when applicable, variation in the axis of rotation for the table,
gantry, and collimator system, and beam flatness and symmetry at the specified
depth.
(-b-) The absorbed dose rate
at various depths in a tissue equivalent phantom for the range of field sizes
used, for each effective energy, that will verify the accuracy of the dosimetry
of all therapy procedures utilized with that therapy beam.
(-c-) The uniformity of the radiation field
to include symmetry, flatness, and dependence on gantry angle.
(-d-) Verification that existing isodose
charts applicable to the specific machine continue to be valid or are updated
to existing machine conditions.
(-e-) Verification of transmission factors
for all accessories such as wedges, block trays, and/or universal and custom
made beam modifying devices.
(VI) Calibration of therapeutic systems
containing asymmetric jaws, multileaf collimation, or dynamic/virtual wedges
shall be performed with an established protocol. The procedures shall be
developed by a licensed medical physicist with a specialty in therapeutic
radiological physics and shall be in writing or documented in an electronic
reporting system. Current recommendations by a national professional
association as the American Association of Physicists in Medicine, Task Group
142 report: "Quality Assurance of Medical Accelerators" published August 17,
2009, would be considered an established protocol.
(VII) Records of calibration measurements
specified in subclause (I) of this clause and dosimetry system calibrations
specified in subclause (III) of this clause shall be maintained by the
registrant in accordance with subsection (l) of this section for inspection by
the agency.
(VIII) A copy of the
latest calibrated absorbed dose rate measured in accordance with subclause (I)
of this clause shall be available at a designated area within the facility
housing that radiation therapy system.
(iii) Spot checks shall be performed on
systems subject to this paragraph during calibrations and thereafter at weekly
intervals with the period between spot checks not to exceed 5 treatment days.
Such radiation output measurements shall meet the following requirements.
(I) The spot check procedures shall be
performed in accordance with established protocol, shall be in writing, or
documented in an electronic reporting system, and shall have been developed by
a licensed medical physicist with a specialty in therapeutic radiological
physics. Either the spot check protocol entitled, "Comprehensive QA for
Radiation Oncology," Task Group 40, Radiation Therapy Committee, American
Association of Physicists in Medicine, Medical Physics 21(4): 581-618, April,
1994, or Task Group 142 report: Quality Assurance of Medical Accelerators,
published by American Association of Physicists in Medicine on August 17, 2009,
are accepted as an established protocol. At a minimum, the spot check protocol
shall include items in subclauses (III) - (VI) of this clause.
(II) If a licensed medical physicist does not
perform the spot check measurements, the results of the spot check measurements
shall be reviewed by a licensed medical physicist at a frequency not to exceed
5 treatment days and a record kept of the review. If the output varies by more
than 3.0% from the expected value, a licensed medical physicist shall be
notified immediately.
(III) The
written spot check procedures shall specify the frequency at which tests or
measurements are to be performed and the acceptable tolerance for each
parameter measured in the spot check when compared to the value for that
parameter determined in the calibration.
(IV) Where a system has built-in devices that
provide a measurement of any parameter during irradiation, such measurement
shall not be utilized as a spot check measurement.
(V) A parameter exceeding a tolerance set by
a licensed medical physicist shall be corrected before the system is used for
patient irradiation.
(VI) Whenever
a spot check indicates a significant change in the operating characteristics of
a system, as specified in a licensed medical physicist's written procedures,
the system shall be recalibrated, as required in this clause of this
subparagraph.
(VII) Records of spot
check measurements and any necessary corrective actions shall be maintained by
the registrant in accordance with subsection (l) of this section for inspection
by the agency.
(VIII) Spot checks
shall be obtained using a system satisfying the requirements of clause
(ii)(III) of this subparagraph.
(iv) Facilities with therapeutic radiation
machines with energies of 1 MeV and above shall procure the services of a
licensed medical physicist with a specialty in therapeutic radiological
physics.
(I) The physicist shall be
responsible for:
(-a-) calibration of
radiation machines;
(-b-)
supervision and review of beam and clinical dosimetry;
(-c-) measurement, analysis, and tabulation
of beam data;
(-d-) establishment
of quality assurance procedures and performance of spot check review;
and
(-e-) review of absorbed doses
delivered to patients.
(II) The licensed medical physicist described
in subclause (I) of this clause shall also be available and responsive to
immediate problems or emergencies.
(4) Radiation therapy simulators.
(A) General requirements. In addition to the
general requirements in paragraph (1)(B), (C), (F), and (H) of this subsection,
radiation therapy simulators shall comply with the following:
(i) Technique chart. A technique chart
relevant to the particular radiation machine shall be provided or
electronically displayed in the vicinity of the console and used by all
operators.
(ii) Operating and
safety procedures. Each registrant shall have and implement written operating
and safety procedures in accordance with paragraph (1)(G) of this
subsection.
(iii) Protective
devices. When utilized, protective devices shall meet the following
requirements.
(I) Protective devices shall be
made of no less than 0.25 mm lead equivalent material.
(II) Protective devices, including aprons,
gloves, and shields shall be checked annually for defects, such as holes,
cracks, and tears. These checks may be performed by the registrant by visual,
tactile, or x-ray imaging. If a defect is found, equipment shall be replaced or
removed from service until repaired. A record of this test shall be made and
maintained by the registrant in accordance with subsection (l) of this section
for inspection by the agency.
(iv) Viewing system. Windows, mirrors, closed
circuit television, or an equivalent system shall be provided to permit the
operator to continuously observe the patient during irradiation. The operator
shall be able to maintain verbal, visual, and aural contact with the
patient.
(v) Operator position. The
operator's position during the exposure shall be such that the operator's
exposure is as low as reasonably achievable (ALARA) and the operator is a
minimum of 6 feet from the source of radiation or protected by an apron,
gloves, or other shielding having a minimum of 0.25 mm lead equivalent
material.
(vi) Holding of tube. In
no case shall an individual hold the tube or tube housing assembly supports
during any radiographic exposure.
(vii) No individuals other than the patient
and the operator(s) shall be in the treatment room during operation of the
simulator.
(viii) Film processing.
(I) Films shall be developed in accordance
with the time-temperature relationships recommended by the film manufacturer.
The specified developer temperature for automatic processing and the
time-temperature chart for manual processing shall be posted in the darkroom.
If the registrant determines an alternate time-temperature relationship is more
appropriate for a specific facility, that time-temperature relationship shall
be documented and posted.
(II)
Chemicals shall be replaced according to the chemical manufacturer's or
supplier's recommendations or at an interval not to exceed 3 months.
(III) Darkroom light leak tests shall be
performed and any light leaks corrected at intervals not to exceed 6
months.
(IV) Lighting in the film
processing/loading area shall be maintained with the filter, bulb wattage, and
distances recommended by the film manufacturer for that film emulsion or with
products that provide an equivalent level of protection against
fogging.
(V) Corrections or repairs
of the light leaks or other deficiencies in subclauses (II), (III), and (IV) of
this clause shall be initiated within 72 hours of discovery and completed no
longer than 15 days from detection of the deficiency unless a longer time is
authorized by the agency. Records of the correction or repairs shall include
the date and initials of the individual performing these functions and shall be
maintained in accordance with subsection (l) of this section for inspection by
the agency.
(VI) Documentation of
the items in subclauses (II), (III), and (V) of this clause shall be maintained
at the site where performed and shall include the date and initials of the
individual completing these items. These records shall be kept in accordance
with subsection (l) of this section for inspection by the agency.
(ix) Alternative processing
systems. Users of daylight processing systems, laser processors,
self-processing film units, or other alternative processing systems shall
follow manufacturer's recommendations for image processing. Documentation that
the registrant is following manufacturer's recommendations shall include the
date and initials of the individual completing the document and shall be
maintained at the site where performed in accordance with subsection (l) of
this section for inspection by the agency.
(x) Digital imaging acquisition systems.
Users of digital imaging acquisition systems shall follow quality
assurance/quality control protocol for image processing established by the
manufacturer or, if no manufacturer's protocol is available, by the registrant.
The registrant shall include the protocol, whether established by the
registrant or the manufacturer in its operating and safety procedures. The
registrant shall document the frequency at which the quality assurance/quality
control protocol is performed. Documentation shall include the date and
initials of the individual completing the document and shall be maintained at
the site where performed in accordance with subsection (l) of this section for
inspection by the agency.
(B) Additional requirements for radiation
therapy simulators used in the general radiographic mode of operation.
(i) Beam quality (HVL). The half-value layer
of the useful beam for a given x-ray tube potential shall not be less than the
values shown in the following Table IV. If it is necessary to determine such
half-value layer at an x-ray tube potential that is not listed in Table IV,
linear interpolation may be made.
(ii)
Technique and exposure indicators.
(I) The
technique factors to be used during an exposure shall be indicated before the
exposure begins except when automatic exposure controls are used, in which case
the technique factors that are set prior to the exposure shall be
indicated.
(II) The indicated
technique factors shall be accurate to within manufacturer's specifications. If
these specifications are not available from the manufacturer, the factors shall
be accurate to within ±10% of the indicated setting.
(iii) Beam limitation.
(I) The beam limiting device (collimator)
shall restrict the useful beam to the area of clinical interest.
(II) A method shall be provided to visually
define the center (cross-hair centering) of the x-ray field to within a 2 mm
diameter.
(III) A method shall be
provided to accurately indicate the distance to within 2 mm.
(IV) The delineator wires shall be accurate
with the indicated setting within 2 mm.
(V) The x-ray field shall be congruent with
the light field within 2 mm.
(iv) Timers. Means shall be provided to
terminate the exposure at a preset time interval, a preset product of current
and time, a preset number of pulses, or a preset radiation exposure to the
image receptor. In addition, it shall not be possible to make an exposure when
the timer is set to a "zero" or "off" position if either position is provided
and a visual and/or audible signal shall indicate when an exposure has been
terminated.
(v) AEC. When an AEC is
provided, an indication shall be made on the control panel when this mode of
operation is selected.
(vi) Timer
reproducibility. When all technique factors are held constant, including
control panel selections associated with AEC systems, the coefficient of
variation of exposure interval for both manual and AEC systems shall not exceed
0.05. This requirement applies to clinically used techniques.
(vii) Exposure reproducibility. When all
technique factors are held constant, including control panel selections
associated with AEC systems, the coefficient of variation of exposure for both
manual and AEC systems shall not exceed 0.05. This requirement applies to
clinically used techniques.
(viii)
Linearity.
(C) Additional requirements for radiation
therapy simulators utilizing fluoroscopic capabilities.
(i) X-ray production in the fluoroscopic mode
shall be controlled by a device that requires continuous pressure by the
fluoroscopist for the entire time of the exposure (continuous pressure type
switch).
(ii) During fluoroscopy
and cinefluorography, the kV and the mA shall be continuously indicated at the
control panel and/or the fluoroscopist's position.
(iii) The SSD shall not be less than the 20
cm for image-intensified fluoroscopes used for examinations as specified in the
registrant's operating and safety procedures. The written operating and safety
procedures shall provide precautionary measures to be adhered to during the use
of this device. The procedures shall provide information on the means to
restore the unit to a 30 cm SSD when the unit is returned to general
service.
(iv) Fluoroscopic timers
shall meet the following requirements.
(I)
Means shall be provided to preset the cumulative on-time of the fluoroscopic
x-ray tube. The maximum cumulative time of the timing device shall not exceed 5
minutes without resetting.
(II) A
signal audible to the fluoroscopist shall indicate the completion of any preset
cumulative on-time. Such signal shall continue to sound while x-rays are
produced until the timing device is reset. In lieu of such signal, the timer
shall terminate the beam after the preset cumulative on-time is
completed.
(v) The
exposure foot switch shall be permanently mounted in the control booth to
ensure that the operator cannot enter the simulator room while the fluoroscope
is activated.
(vi) Simulators shall
duplicate the geometric conditions of the radiation therapy equipment plan and
therefore measurements regarding geometric conditions shall be performed in
accordance with subsection (h)(3)(C)(iii)(I) of this section.
(vii) If the treatment-planning system is
different from the treatment-delivery system, the accuracy of electronic
transfer of the treatment-delivery parameters to the treatment-delivery unit
shall be verified at the treatment location.
(D) Additional requirements for radiation
therapy simulators utilizing CT capabilities. CT simulators producing digital
images only are exempt from the requirements of this subparagraph and paragraph
(h)(4)(A)(i), (viii), and (ix) of this subsection.
(i) Equipment requirements.
(I) Tomographic systems shall meet the
following requirements.
(-a-) For any single
tomogram system, means shall be provided to permit visual determination of the
tomographic plane or a reference plane offset from the tomographic
plane.
(-b-) For any multiple
tomogram system, means shall be provided to permit visual determination of the
tomographic plane or a reference plane offset from the tomographic
plane.
(-c-) If a device using a
light source is used to satisfy the requirements of item (-a-) or (-b-) of this
subclause, the light source shall provide illumination levels sufficient to
permit visual determination of the location of the tomographic plane or
reference plane under ambient light conditions of up to 500 lux.
(II) The CT x-ray system shall be
designed such that the CT conditions of operation to be used during a scan or a
scan sequence are indicated prior to the initiation of a scan or a scan
sequence. On equipment having all or some of these conditions of operation at
fixed values, this requirement may be met by permanent markings. Indication of
CT conditions shall be visible from any position from which scan initiation is
possible.
(III) The x-ray control
and gantry shall provide visual indication whenever x rays are produced and, if
applicable, whether the shutter is open or closed.
(IV) Means shall be provided to require
operator initiation of each individual scan or series of scans.
(V) All emergency buttons/switches shall be
clearly labeled as to their functions.
(VI) Termination of exposure shall be as
follows.
(-a-) Means shall be provided to
terminate the x-ray exposure automatically by either de-energizing the x-ray
source or shuttering the x-ray beam in the event of equipment failure affecting
data collection. Such termination shall occur within an interval that limits
the total scan time to no more than 110% of its preset value through the use of
either a backup timer or devices that monitor equipment function.
(-b-) A signal visible to the operator shall
indicate when the x-ray exposure has been terminated through the means required
by item (-a-) of this subclause.
(-c-) The operator shall be able to terminate
the x-ray exposure at any time during a scan or series of scans under CT x-ray
system control, of greater than 0.5 second duration. Termination of the x-ray
exposure shall necessitate resetting of the CT conditions of operation prior to
initiation of another scan.
(VII) CT x-ray systems containing a gantry
manufactured after September 3, 1985, shall meet the following requirements.
(-a-) The total error in the indicated
location of the tomographic plane or reference plane shall not exceed 5
mm.
(-b-) If the x-ray production
period is less than 0.5 second, the indication of x-ray production shall be
actuated for at least 0.5 second. Indicators at or near the gantry shall be
discernible from any point external to the patient opening where insertion of
any part of the human body into the primary beam is possible.
(-c-) The deviation of indicated scan
increment versus actual increment shall not exceed ±1 mm with any mass
from 0 to 100 kilograms (kg) resting on the support device. The patient support
device shall be incremented from a typical starting position to the maximum
incremented distance or 30 cm, whichever is less, and then returned to the
starting position. Measurement of actual versus indicated scan increment can be
taken anywhere along this travel.
(ii) Facility design requirements.
(I) Provision shall be made for two-way aural
communication between the patient and the operator at the control
panel.
(II) Windows, mirrors,
closed-circuit television, or an equivalent shall be provided to permit
continuous observation of the patient during irradiation and shall be so
located that the operator can observe the patient from the console.
(-a-) Should the viewing system described in
subclause (II) of this clause fail or be inoperative, treatment shall not be
performed with the unit until the system is restored.
(-b-) In a facility that has a primary
viewing system by electronic means and an alternate viewing system, should both
viewing systems described in subclause (II) of this clause fail or be
inoperative, treatment shall not be performed with the unit until 1 of the
systems is restored.
(iii) Dose measurements of the radiation
output of the CT x-ray system.
(I) Dose
measurements of the radiation output of the CT x-ray system shall be performed
by a licensed medical physicist with a specialty in diagnostic radiological
physics. If the CT system is used for simulation purposes only, the following
requirements do not apply. If the unit is also used for diagnostic procedures,
the measurements shall be performed as follows:
(-a-) within 30 days after installation and
thereafter, at intervals not to exceed 14 months;
(-b-) when major maintenance that could
affect radiation output is performed; or
(-c-) when a major change in equipment
operation (e.g. introduction of a new software package) is
accomplished.
(II)
Measurements of the radiation output of a CT x-ray system shall be performed
with a calibrated dosimetry system. The dosimetry system calibration shall be
traceable to a national standard. The calibration interval shall not exceed 24
months.
(III) Records of dose
measurements specified in clause (iii) of this subparagraph shall be maintained
by the registrant in accordance with subsection (l) of this section for
inspection by the agency.
(iv) A maintenance schedule shall be
developed in accordance with the manufacturer's United States Department of
Health and Human Services maintenance schedule. The schedule shall include, but
need not be limited to the following:
(I) dose
measurements required by clause (iii)(I) of this subparagraph; and
(II) acquisition of images obtained with
phantoms using the same processing mode and CT conditions of operation as are
used to perform dose measurements required by clause (iii)(I) of this
subparagraph. The registrant shall retain either of the following in accordance
with subsection (l) of this section for inspection by the agency:
(-a-) photographic copies of the images
obtained from the image display device; or
(-b-) images stored in digital form.
(i) Medical events (misadministrations).
(1) Medical events involving equipment
operating at energies below 1 MeV and electronic brachytherapy devices, shall
be reported when:
(A) the event involves the
wrong individual, or wrong treatment site;
(B) the treatment consists of 3 or fewer
fractions and the calculated total administered dose differs from the total
prescribed dose by more than 10% of the total prescribed dose; or
(C) the calculated total administered dose
differs from the total prescribed dose by more than 20% of the total prescribed
dose.
(2) Medical events
involving equipment operating with energies of 1 MeV and above shall be
reported when:
(A) the event involves the
wrong individual, wrong type of radiation, wrong energy, or wrong treatment
site;
(B) the treatment consists of
3 or fewer fractions and the calculated total administered dose differs from
the total prescribed dose by more than 10% of the total prescribed
dose;
(C) the calculated total
administered dose differs from the total prescribed dose by more than 20% of
the total prescribed dose; or
(D)
the combination of external beam radiation therapy and radioactive material
therapy causes over-radiation of a patient resulting in physical injury or
death.
(j) Reports of medical events (misadministrations).
(1) For a medical event, a registrant shall
do the following:
(A) notify the agency by
telephone no later than 24 hours after discovery of the event;
(B) notify the referring physician and also
notify the patient of the event no later than 24 hours after its discovery,
unless the referring physician personally informs the registrant either that he
or she will inform the patient or that, based on medical judgement, telling the
patient would be harmful. The registrant is not required to notify the patient
without first consulting the referring physician. If the referring physician or
patient cannot be reached within 24 hours, the registrant shall notify the
patient as soon as possible thereafter. The registrant may not delay any
appropriate medical care for the patient, including any necessary remedial care
as a result of the event, because of any delay in notification;
(C) submit a written report to the agency
within 15 days after the discovery of the event. The report shall not include
the patient's name or other information that could lead to identification of
the patient. The written report shall include the following:
(i) registrant's name and certificate of
registration number;
(ii)
prescribing physician's name;
(iii)
a brief description of the event;
(iv) why the event occurred;
(v) the effect on the patient;
(vi) what improvements are needed to prevent
recurrence;
(vii) actions taken to
prevent recurrence;
(viii) whether
the registrant notified the patient, or the patient's responsible relative or
guardian (this person will be subsequently referred to as "the patient"); and
if not, why not; and
(ix) if the
patient was notified, what information was provided to the patient;
and
(D) furnish the
following to the patient within 15 days after discovery of the event if the
patient was notified:
(i) a copy of the
report that was submitted to the agency; or
(ii) a brief description of both the event
and the consequences, as they may affect the patient, provided a statement is
included that the report submitted to the agency can be obtained from the
registrant.
(2) Each registrant shall retain a record of
each event in accordance with subsection (l) of this section for inspection by
the agency. The record shall contain the following:
(A) the names of all individuals involved
(including the prescribing physician, allied health personnel, the patient, and
the patient's referring physician);
(B) the patient's identification
number;
(C) a brief description of
the event;
(D) why it
occurred;
(E) the effect on the
patient;
(F) what improvements are
needed to prevent recurrence; and
(G) the actions taken to prevent
recurrence.
(3) Aside
from the notification requirement, nothing in subsection (i) of this section
and paragraphs (1) and (2) of this subsection shall affect any rights or duties
of registrants, and physicians in relation to each other, patients, or the
patient's responsible relatives or guardians.
(k) Additional requirements for electronic brachytherapy devices.
(1) Technical
requirements for electronic brachytherapy devices.
(A) The timer shall:
(i) have a display provided at the treatment
control panel and a pre-set time selector;
(ii) activate with the production of
radiation and retain its reading after irradiation is interrupted. After
irradiation is terminated and before irradiation can be reinitiated, it shall
be necessary to reset the elapsed time indicator to zero;
(iii) terminate irradiation when a
pre-selected time has elapsed, if any dose monitoring system present has not
previously terminated irradiation;
(iv) permit selection of exposure times as
short as 1 second;
(v) not permit
an exposure if set at zero; and
(vi) be accurate to within 1.0% of the
selected value or 1 second, whichever is greater.
(B) The control panel, in addition to the
displays required in subparagraph (A) of this paragraph, shall have the
following:
(i) an indication of whether
electrical power is available at the control panel and if activation of the
x-ray tube is possible;
(ii) means
for indicating x-rays are being produced;
(iii) means for indicating x-ray tube
potential and current; and
(iv)
means for terminating an exposure at any time.
(C) All emergency buttons/switches shall be
clearly labeled as to their functions.
(2) Surveys, calibrations, and spot checks.
(A) Surveys shall be performed as follows.
(i) All facilities having electronic
brachytherapy device(s) shall have an initial survey made by a licensed medical
physicist, with a specialty in therapeutic radiological physics, who shall
provide a written report of the survey to the registrant. Additional surveys
shall be done as follows:
(I) when making any
change in the portable shielding;
(II) when making any change in the location
where the electronic brachytherapy device is used within the treatment room;
and
(III) when relocating the
electronic therapy device.
(ii) The registrant shall maintain a copy of
the initial survey report and all subsequent survey reports in accordance with
subsection (l) of this section for inspection by the agency.
(iii) The survey report shall indicate all
instances where the installation is in violation of applicable requirements of
this chapter.
(B)
Calibrations shall be performed as follows.
(i) Calibration procedures shall be in
writing, or documented in an electronic reporting system, and shall have been
developed by a licensed medical physicist with a specialty in therapeutic
radiological physics.
(ii) The
registrant shall make calibration measurements required by this section in
accordance with any current recommendations from a recognized, national
professional association (such as the American Association of Physicists in
Medicine Report Number 152) for electronic brachytherapy, when available.
Equivalent alternative methods are acceptable. In the absence of a protocol by
a national professional association, published protocol included in the device
manufacturer operator's manual should be followed.
(iii) The calibration of the electronic
brachytherapy device shall be performed after change of the x-ray tube or
replacement of components that could cause a change in the radiation output.
The calibrations shall be such that the dose at a reference point in water or
plastic phantom can be calculated to within an uncertainty of 5.0%.
(iv) The calibration of the radiation output
of the electronic brachytherapy device shall be performed by a licensed medical
physicist with a specialty in therapeutic radiological physics who is
physically present at the facility during such calibration.
(v) The calibration of the therapeutic
electronic brachytherapy device shall include verification that the electronic
brachytherapy device is operating in compliance with the design
specifications.
(vi) Calibration of
the radiation output of the electronic brachytherapy device shall be performed
with a calibrated dosimetry system. The dosimetry calibration shall be
traceable to a national standard. The calibration interval shall not exceed 24
months.
(vii) Records of
calibration measurements shall be maintained by the registrant in accordance
with subsection (l) of this section for inspection by the agency.
(viii) A copy of the latest calibrated
absorbed dose rate measured on the electronic brachytherapy device shall be
available at a designated area within the therapy facility housing the
electronic brachytherapy device.
(C) Spot check procedures.
(i) Spot check procedures shall be in
writing, or documented in an electronic reporting system, and shall have been
developed by a licensed medical physicist with a specialty in therapeutic
radiological physics.
(ii) If a
licensed medical physicist does not perform the spot check measurements, the
results of the spot check measurements shall be reviewed by a licensed medical
physicist with a specialty in therapeutic radiological physics within 2
treatment days and a record made of the review.
(iii) The written spot check procedures shall
specify the operating instructions that shall be carried out whenever a
parameter exceeds an acceptable tolerance as established by the licensed
medical physicist.
(iv) The
certified physician or licensed medical physicist shall prevent the clinical
use of a malfunctioning device until the malfunction identified in the spot
check has been evaluated and corrected or, if necessary, the equipment
repaired.
(v) Records of the
written spot checks and any necessary corrective actions shall be maintained by
the registrant in accordance with subsection (l) of this section for inspection
by the agency. A copy of the most recent spot check shall be available at a
designated area within the therapy facility housing that therapeutic radiation
system.
(vi) Spot checks shall be
obtained using a dosimetry system satisfying the requirements of subparagraph
(B)(vi) of this paragraph.
(l) Records for agency inspection. The registrant shall maintain the following records at the time intervals specified, for inspection by the agency. The records may be maintained in electronic format.
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