13-030 Code Vt. R. 13-140-030-X - RADIOLOGICAL HEALTH
PART A. RADIATION-PRODUCING MACHINES
1.0 Authority.
This Rule is adopted pursuant to 18 V.S.A. Chapter 32.
2.0 Purpose and Scope.
2.1. Part A of this Rule establishes
standards for the control of ionizing radiation-producing machines for the
protection of occupational and public health and safety.
2.2. Part A of this Rule regulates x-ray and
other ionizing radiographic diagnostic and/or therapeutic equipment used by
physicians, dentists, and other health professionals, as well as veterinary,
industrial and other non-medical x-ray equipment, and occupational sources of
radiation.
2.3. Part A of this Rule
applies to all persons who receive, possess, use, or transfer machine-based
sources of radiation, except that nothing in this Rule shall be construed to
limit the kind or amount of radiation that may be applied intentionally to a
patient for diagnostic or therapeutic purposes by or under the direction of a
practitioner of the healing arts licensed by the State of Vermont.
3.0 Definitions.
3.1. "AAPM" means the American Association of
Physicists in Medicine.
3.2.
"Absorbed dose" means the energy imparted by ionizing radiation per unit of
mass of irradiated material. The units of absorbed dose are the rad and the
gray (Gy).
3.3. "Accredited
Dosimetry Calibration Laboratory (ADCL)" means a laboratory, accredited by
AAPM, which provides calibration services for most radiation measurement
instrumentation available in the medical or health physics community. Every
piece of equipment used in this laboratory has its calibration directly
traceable to the National Institute of Standards and Technology (NIST)."
3.4. "Adult" means an individual 18
years or more in age.
3.5.
"Agreement State" means any State with which the U.S. Nuclear Regulatory
Commission or the U.S. Atomic Energy Commission has entered into an effective
agreement under subsection
274 b. of the Atomic Energy Act of 1954, as
amended (73 Stat. 689).
3.6. "Air
kerma (exposure) rate" means the kinetic energy released in the mass of a small
volume of air by ionizing radiation, per unit time. Air kerma is measured in
joules per kilogram (J/kg). For diagnostic x-rays, air kerma is the same as the
absorbed dose in gray (Gy) delivered to the volume of air in the absence of
scatter. (1 Gy = 100 rem)
3.7.
"Analytical x-ray system" means a group of components utilizing x-rays to
determine the elemental composition, examine the microstructure, and/or
ascertain certain characteristics of materials.
3.8. "Annual" means twelve consecutive
months.
3.9. "As low as is
reasonably achievable (ALARA)" means the principle of making every reasonable
effort to maintain exposures to radiation as far below the dose limit in this
Rule as is practical, consistent with the purpose for which the regulated
activity is undertaken, taking into account the state of technology, and the
economics of improvements in relation to the benefits to the public health and
safety, and other societal and socioeconomic considerations, and in relation to
utilization of nuclear energy and regulated materials in the public
interest.
3.10. "Background
radiation" means radiation from cosmic sources; naturally occurring radioactive
material, including radon (except as a decay product or source or special
nuclear material); and global fallout as it exists in the environment from the
testing of nuclear explosive devices or from past nuclear accidents such as
Chernobyl that contribute to background radiation and are not under the control
of the regulated entity. It does not include radiation from source, byproduct,
or special nuclear materials regulated by this Rule.
3.11. "Cabinet x-ray system" means an x-ray
system with the x-ray tube installed in an enclosure called a cabinet that is
independent of existing architectural structures except the floor. The cabinet
x-ray system is intended to contain at least that portion of a material being
irradiated, provide radiation attenuation, and exclude personnel from its
interior during generation of radiation. This definition includes x-ray systems
designed primarily for the inspection of carry-on baggage at airline, railroad,
and bus terminals, and in similar facilities. An x-ray tube used within a
shielded part of a building, or x-ray equipment that may temporarily or
occasionally incorporate portable shielding, is not considered a cabinet x-ray
system.
3.12. "Commissioner" means
the Commissioner of the Vermont Department of Health, or designee.
3.13. "Declared pregnant person" means a
person who has voluntarily informed the regulated entity, in writing, of their
pregnancy and the estimated date of conception. The declaration remains in
effect until the declared pregnant person withdraws the declaration in writing
or is no longer pregnant.
3.14.
"Department" means the Vermont Department of Health.
3.15. "Diagnostic x-ray system" means an
assemblage of components for the generation, emission, and reception of x-rays
and the transformation, storage, and visual display of the resultant x-ray
image, with the assembled system designed and used for irradiation of any part
of the human or animal body for the purpose of diagnosis or
visualization.
3.16. "Direct
supervision" means that the person being supervised remains in the physical
presence of the supervisor at all times.
3.17. "Dose-area product (DAP)" means the
product of the air kerma and the area of the irradiated field and is typically
expressed in Gy-cm2, so it does not change with distance from the x-ray tube.
3.18. "Dose equivalent" means the
product of the absorbed dose in tissue, quality factor, and all other necessary
modifying factors at the location of interest. The units of dose equivalent are
the rem and sievert (Sv). Other necessary modifying factors include the
specific energy or spectrum of energies of radiation; the specific size and
shape of the source of radiation and radiation detector; the specific radiation
scattering characteristics in the environment; differences in temperature,
humidity, and atmospheric pressure of the radiation detector and radiation
environment; limitations of the radiation detector; characteristics of the
specific tissues absorbing the radiation; and differences in physiological
responses in specific persons absorbing the radiation.
3.19. "Effective dose equivalent" means the
sum of the products of the dose equivalent to the organ or tissue and the
weighting factors applicable to each of the body organs or tissues that are
irradiated.
3.20. "Electronic
brachytherapy system" means a therapeutic radiation machine in which an x-ray
source is used to irradiate tissue by intracavitary, intraluminal,
interstitial, or similar application with the source in contact with, very
close to, or at a distance usually less than five centimeters from the target
volume.
3.21. "Embryo/fetus" means
the developing human organism from conception until the time of
birth.
3.22. "Exposure" means being
exposed to ionizing radiation or to radioactive material. The unit of
measurement of external exposure is the roentgen (R).
3.23. "Exposure value" means the numerical
value of the measured exposure in units of milliroentgen or roentgen where 1
roentgen equals exactly 2.58 x 10-4 coulombs per kilogram of air at standard
temperature and pressure.
3.24.
"External dose" means that portion of the dose equivalent received from
radiation sources outside the body.
3.25. "Extremity" means hand, elbow, arm
below the elbow, foot, knee, or leg below the knee.
3.26. "Facility" means the location,
building, vehicle, or complex under one administrative control, at which one or
more radiation machines are installed, located and/or used.
3.27. "Gray" means the SI unit of absorbed
dose. One gray is equal to an absorbed dose of 1 Joule/kilogram (100
rads).
3.28. "General supervision"
means that the supervisor is readily available for consultation or intervention
on the premises where radiologic technology services are being
provided.
3.29. "Healing arts"
means medicine, surgery, dentistry, osteopathy, podiatry, and
chiropractic.
3.30. "High radiation
area" means an area, accessible to individuals, in which radiation levels from
radiation sources external to the body could result in an individual receiving
a dose equivalent in excess of 1 mSv (0.1 rem) in one hour at 30 centimeters
from any source of radiation or 30 centimeters from any surface that radiation
penetrates.
3.31. "Individual"
means any human being.
3.32.
"Individual monitoring" means:
3.32.1. The
assessment of dose equivalent by the use of devices designed to be worn by an
individual; or
3.32.2. The
assessment of dose equivalent by the use of survey data.
3.33. "Industrial radiographic machine" means
an instrument designed for the examination of the structure of materials by the
nondestructive method of utilizing ionizing radiation to make radiographic
images. This does not include machines containing radioactive
materials.
3.34. "Interventional
x-ray" means imaging used for guidance of procedures. Imaging includes, but is
not limited to, fluoroscopy and CT scan.
3.35. "Isocenter" means the center of the
smallest sphere through which the beam axis passes when the equipment moves
through a full range of rotations about its common center.
3.36. "Limits" (dose limits) means the
permissible upper bounds of radiation doses.
3.37. "Member of the public" means any
individual except when that individual is receiving an occupational
dose.
3.38. "Mini c-arm x-ray
system" means a system that meets the following criteria:
3.38.1. Source-image receptor distance less
than or equal to 45 cm (18 inches)
3.38.2. Field of view less than or equal to
15 cm (6 inches)
3.38.3. Maximum
kVp less than or equal to 80 kVp; and
3.38.4. Maximum mA less than or equal to 0.25
mA
3.39. "Minor" means an
individual less than 18 years of age.
3.40. "Monitoring" (radiation monitoring,
radiation protection monitoring) means the measurement of radiation levels,
concentrations, surface area concentrations or quantities of radioactive
material and the use of the results of these measurements to evaluate potential
exposures and doses.
3.41.
"Occupational dose" means the dose received by an individual in the course of
employment in which the individual's assigned duties involve exposure to
radiation or to radioactive material from regulated and unregulated sources of
radiation, whether in the possession of the regulated entity or other person.
Occupational dose does not include doses received from background radiation,
from any medical administration the individual has received, from exposure to
individuals administered radioactive material and released, from voluntary
participation in medical research programs, or as a member of the
public.
3.42. "Personal
Supervision" means a Qualified Medical Physicist must exercise General
supervision and be present in the room during the performance of the
procedure.
3.43. "Physician" means
an individual licensed to practice medicine under 26 V.S.A. chapter 23 or
33.
3.44. "Position Indicator
Device" means a device on dental x-ray equipment used to indicate the beam
position and to establish a definite source-surface (skin) distance, without
regard to whether the device incorporates or serves as a beam-limiting
device.
3.45. "Public dose" means
the dose received by a member of the public from exposure to radiation or to
radioactive material released by a regulated entity, or to any other source of
radiation under the control of a regulated entity. Public dose does not include
occupational dose or doses received from background radiation, from any medical
administration the individual has received, from exposure to individuals
administered radioactive material and released, or from voluntary participation
in medical research programs.
3.46.
"Qualified Expert" means a person who designs or evaluates shielding for a
radiation machine. A Qualified Expert shall have current certification in
health physics or a subfield of medical physics by:
3.46.1. The American Board of Medical
Physics; or
3.46.2. The American
Board of Health Physics; or
3.46.3.
The Canadian College of Medical Physics; or
3.46.4. The American Board of Radiology in a
radiological physics category; or
3.46.5. The American Board of Science in
Nuclear Medicine in: radiation protection or nuclear medicine physics and
instrumentation; and
3.46.5.1. Holds a master
or doctorate degree from an accredited college or university in physics,
biophysics, radiological physics, health physics, or medical physics;
and
3.46.5.2. Has satisfactorily
completed 2 years of training and work experience acceptable to the Department
that includes one year of documented, full-time training in the appropriate
field under the supervision of a Qualified Expert.
3.47. "Qualified Medical
Physicist" means an individual who is competent to independently provide
clinical professional services in one or more of the subfields of medical
physics. A Qualified Medical Physicist is qualified to practice only in the
subfield(s) in which they are certified by a national certifying body. A list
of the subfields and the recognized national certifying bodies can be found on
the Department's website.
3.48.
"Quarter" means a period of time equal to one-fourth of the year observed by
the regulated entity (approximately 13 consecutive weeks), providing that the
beginning of the first quarter in a year coincides with the starting date of
the year and that no day is omitted or duplicated in consecutive
quarters.
3.49. "Rad" means the
special unit of absorbed dose. One rad is equal to an absorbed dose of 100
ergs/gram or 0.01 Joule/kilogram (0.01 gray). A subunit of the rad is the
millirad. One millirad = 0.001 rad.
3.50. "Radiation" and "ionizing radiation"
mean gamma rays and X-rays, alpha and beta particles, high speed electrons,
neutrons, protons, and other nuclear particles. Radiation, as used in this
Rule, does not include non-ionizing radiation, such as radio-or microwaves, or
visible, infrared, or ultraviolet light.
3.51. "Radiation machine" means any device
capable of producing radiation except those devices with radioactive material
as the only source of radiation. Radiation machine includes any accelerator
and/or x-ray system, subsystem, or equipment.
3.52. "Radiation Protection Survey" means an
evaluation of the radiological conditions and potential hazards incident to the
production, use, transfer, release, disposal, or presence of sources of
radiation. When appropriate, such evaluation includes, but is not limited to,
tests, physical examinations, and measurements of levels of
radiation.
3.53. "Radiation Safety
Officer" means, for Part A of this Rule, an individual who, under the
authorization of the licensee or registrant of a radiation installation,
administers a radiation protection program in accordance with Part A of this
Rule and is qualified by training and experience in radiological health to
evaluate the radiation hazards of such installation and administer such
radiation protection program. Additionally, for healing-arts purposes, the
radiation safety officer shall be:
3.53.1. A
practitioner of the healing arts or veterinary medicine, licensed in accordance
with State of Vermont regulations to engage in the healing arts or veterinary
medicine, and practicing within the scope of their professional practice; or
3.53.2. A physicist certified by
the American Board of Health Physics, the American Board of Radiology in a
branch of physics related to the type of use of radiation sources in the
installation, or an individual with equivalent training and
experience.
3.54.
"Radiation Therapist" means an individual who possesses a current State of
Vermont Radiation Therapist professional license in accordance with State
licensing requirements.
3.55.
"Radiation Therapy Physician" means an individual who possesses a current State
of Vermont professional license to practice medicine in accordance with State
licensing requirements, and who is trained to use therapeutic radiation
machines on humans. A Radiation Oncologist is one type of radiation therapy
physician.
3.56. "Radiation Therapy
Physicist" means an individual who is currently registered with the Department
as a Qualified Medical Physicist. A Radiation Therapy Physicist must also meet
the applicable requirements of Section
9.3, including a certification in the
applicable subfield.
3.57.
"Radiation Therapy Veterinarian" means a veterinarian trained to use
therapeutic radiation machines on animals.
3.58. "Radiographer" means for the purposes
of Part A, any individual who performs or who, in attendance at the site where
the industrial radiographic machine(s) are being used, personally supervises
industrial radiographic operations and who is responsible to the registrant for
ensuring compliance with the requirements of the Department's
regulations.
3.59. "Radiographer's
assistant" means, for the purposes of Part A, any individual who under the
direct supervision of a radiographer, uses radiographic exposure devices or
radiation survey instruments in industrial radiography.
3.60. "Registrant" means any person who is
registered with the Department and is legally obligated to register with the
Department pursuant to these regulations.
3.61. "Regulated entity" means all persons
who receive, possess, use, or transfer sources of ionizing radiation in the
State of Vermont.
3.62. "Rem" means
the special unit of any of the quantities expressed as dose equivalent. The
dose equivalent in rems is equal to the absorbed dose in rads multiplied by the
quality factor (1 rem = 0.01 sievert). A subunit of the rem is the millirem
(mrem). One mrem = 0.001 rem.
3.62.1. As used
in this Rule, the quality factors for converting absorbed dose to dose
equivalent are shown in Table I.
TABLE 1-Quality Factors and Absorbed Dose
Equivalencies
|
Type of Radiation |
Quality Factor (Q) |
Absorbed Dose Equal to a Unit Dose Equivalent |
|
X-, gamma, or beta |
1 |
1 |
|
Alpha particles, multiple- charged particles, fission fragments, and heavy |
20 |
0.05 |
|
particles of unknown charge |
||
|
Neutrons of unknown energy |
10 |
0.1 |
|
High-energy protons |
10 |
0.1 |
3.63. "Restricted area" means an area, access
to which is limited by the registrant for the purpose of protecting individuals
against undue risks from exposure to radiation. Restricted area does not
include areas used as residential quarters, but separate rooms in a residential
building may be set apart as a restricted area.
3.64. "Roentgen" means a measure of exposure
and is equivalent to 2.58 x 10-4 coulombs per kilogram in air at standard
temperature and pressure. A subunit of the roentgen is the milliroentgen (mR).
One mR = 0.001 R.
3.65. "Scan" or
"patient scanning" means the 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
3.66. "Scan increment" means 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.
3.67. "Security
screening system" means radiation-generating equipment used for the sole
purpose of screening an individual who is in custody of a law enforcement
agency to identify contraband items that would present a security threat within
a secured facility perimeter.
3.68.
"Sievert" means the SI unit of any of the quantities expressed as dose
equivalent. The dose equivalent in sieverts is equal to the absorbed dose in
grays multiplied by the quality factor. One Sv = 100 rems.
3.69. "Site boundary" means the line beyond
which the land or property is not owned, leased, or otherwise controlled by the
regulated entity.
3.70.
"Source-image receptor distance (SID)" means the distance from the source to
the center of the input surface of the image receptor.
3.71. "Source-skin distance (SSD)" means the
distance between the source and the skin of the patient.
3.72. "Stochastic effects" means health
effects that occur randomly and for which the probability of the effect
occurring, rather than its severity, is assumed to be a linear function of dose
without threshold. Hereditary effects and cancer incidence are examples of
stochastic effects.
3.73. "Storage"
means a condition in which a device or source is not being used for an extended
period of time and has been made inoperable.
3.74. "Survey" means an evaluation of the
radiological conditions and potential hazards incident to the production, use,
transfer, release, disposal, or presence of sources of radiation. When
appropriate, such an evaluation includes a physical survey of the location of
radiation-producing machines and measurements or calculations of levels of
radiation.
3.75. "Target-to-Skin
Distance (TSD)" means the distance measured along the beam axis from the center
of the front surface of the x-ray target, or electron virtual source, or the
nominal position of the electron source to the surface of the irradiated object
or patient.
3.76. "Therapeutic
radiation machine" means x-ray or electron-producing equipment designed and
used for radiation therapy, including external beam and electronic
brachytherapy systems.
3.77.
"Unrestricted area" means any space not meeting the definition of restricted
area.
3.78. "Useful beam" and
"Primary beam" means the radiation which passes through an aperture of the
source housing by a direct path from the x-ray tube or a radioactive source
located in the radiation source housing.
3.79. "Weighting factor" for an organ or
tissue means the proportion of the risk of stochastic effects resulting from
irradiation of that organ or tissue to the total risk of stochastic effects
when the whole body is irradiated uniformly. For calculating the effective dose
equivalent, the weighting factors can be found in Table II.
Table II. Organ Dose Weighting Factors
|
Tissue |
Tissue weighting factor wT |
$(sigma$)wT |
|
Bone-marrow (red), colon, lung, stomach, breast, remaining tissues(*) |
0.12 |
0.72 |
|
Gonads |
0.08 |
0.08 |
|
Bladder, esophagus, liver, thyroid |
0.04 |
0.16 |
|
Bone surface, brain, salivary glands, skin |
0.01 |
0.04 |
|
Total |
1.00 |
*Remaining tissues: Adrenals, extrathoracic region, gall bladder, heart, kidneys, lymphatic nodes, muscle, oral mucosa, pancreas, prostate, small intestine, spleen, thymus, uterus/cervix.
3.80. "Whole body" means, for purposes of
external exposure, head, trunk (including male gonads), arms above the elbow,
or legs above the knee.
4.0. Exemptions.
4.1. The following materials, machines, and
conditions are exempt from Part A of this Rule:
4.1.1. Radioactive materials of an equivalent
specific radioactivity not exceeding that of natural potassium (10-9 curies per
gram of potassium).
4.1.2.
Quantities of byproduct, source, accelerator produced, and special nuclear
materials exempt from licensing requirements of the U.S. Nuclear Regulatory
Commission (NRC).
4.1.3. Domestic
television receivers and video display terminals, provided the effective dose
rate at 5 centimeters from any outer surface is less than 0.5 mrem per
hour.
4.1.4. Other electrical
equipment that produces radiation incidental to its operation for other
purposes, provided that the dose equivalent rate averaged over an area of 10
cm2 does not exceed 5 [mu]Sv (0.5 mrem) per hour at 5 centimeters from any
accessible surface of such equipment. The production, testing, or factory
servicing of such equipment shall not be exempt.
4.1.5. Radiation machines in transit or in
storage incident to transit. This exemption does not apply to the providers of
radiation machines for mobile services. Facilities that have placed all
radiation machines in storage, including on-site storage, and have notified the
Department in writing, are exempt from the requirements of this Rule. This
exemption is void if any radiation machine is energized resulting in the
production of radiation.
4.1.6. A
radiation machine that is out of service yet kept at a facility is exempt from
the registration requirements provided the radiation machine has been made
physically inoperable by inactivating or dismantling the electrical circuitry
such that the radiation machine is not capable of producing
radiation.
4.1.7. Financial
institutions that take possession of radiation machines as the result of
foreclosure, bankruptcy, or other default of payment are exempt from the
requirements in this Part to the extent that they demonstrate that the unit is
operable for the sole purpose of selling, leasing, or transferring. However,
written notification to the Department shall be required.
4.1.8. Other sources of radiation that have
been granted a waiver by the Department.
5.0 Registration.
5.1. Purpose and Scope
5.1.1. This Section provides for the
registration with the Department of ionizing radiation machine facilities and
persons providing radiation machine installation, servicing and/or
services.
5.1.2. In addition to the
requirements of this Section, all registrants are subject to the applicable
provisions of Section
7.0 of this Rule. In addition, some
registrants are subject to provisions of Sections
8.0,
9.0,
10.0,
11.0, or 12.0, of this
Rule.
5.2. Prohibitions
5.2.1. All registrants shall prohibit any
person from providing radiation machine servicing or services as described in
5.7.4 to their radiation machine facility until such person provides evidence
of registration with the Department as a provider of services in accordance
with Section
5.7.
5.3. Shielding Plan Review
5.3.1. Prior to construction, the floor
plans, shielding specifications and equipment arrangement of all new
installations, or modifications of existing installations utilizing ionizing
radiation machines shall be submitted by the applicant to the Department for
review and approval. The required information is denoted in the Department's
Shielding Plan Review Guidance document, which can be found on the Department's
website.
5.3.2. Prior to the plan
review and approval, the Department may require the applicant to utilize a
shielding design service provider that is registered with the Department in
order to determine the shielding requirements.
5.3.3. The Department may require additional
conditions as necessary, including modifications should a subsequent analysis
of operating conditions indicate the possibility of an individual receiving a
dose in excess of the limits prescribed in Sections
7.2 through
7.6 of this Rule.
5.3.4. After installation of a radiation
machine, the registrant shall maintain for inspection by the Department:
5.3.4.1. The maximum rated technique factors
of each machine;
5.3.4.2. A scale
drawing of the room in which a stationary radiation machine system is located
with such drawing indicating the use of areas adjacent to the room and an
estimation of the extent of occupancy by an individual in such areas. In
addition, the drawing shall include:
5.3.4.2.1. The results of a survey for
radiation levels present at the operator's position and at pertinent points
outside the room at specified test conditions; or
5.3.4.2.2. The type and thickness of
materials, or lead equivalency, of each protective barrier, and the results of
a visual inspection of shielding installed.
5.3.5. A facility area is exempt from the
requirements of Section
5.3 if:
5.3.5.1. Only dental intraoral, dental
panoramic, mini-c-arm, podiatric, or bone densitometry equipment is used in the
area;
5.3.5.2. Only mobile or
portable x-ray equipment is used infrequently and not regularly in the same
location;
5.3.5.3. Only cabinet
x-ray equipment is used in the area; or
5.3.5.4. Exemption for a specific area or
location has been applied for in writing and granted by the
Department.
5.4. Registration of Radiation Machine
Facilities.
5.4.1. Each regulated entity
having a radiation machine facility, except those exempted in Section
4.0, shall apply for registration of such
facility with the Department prior to the operation of a radiation machine
facility. Application for registration shall be completed on forms published by
the Department and shall contain all the information required by the form and
accompanying instructions.
5.4.2. A
practitioner, licensed by the respective state licensing board, responsible for
directing the operation of radiation machines, shall be designated on each
healing arts application. The signature of the administrator, president, or
chief executive officer will be accepted in lieu of a licensed practitioner's
signature if the facility has more than one licensed practitioner (for example,
hospitals, large clinics, or multi-practitioner practices).
5.4.3. Facilities shall register each source
of ionizing radiation with the Department within 30 days after the acquisition
of such source.
5.4.4. The owner or
person having possession of any source of ionizing radiation not exempted in
Section 4.0 shall re-register
such source every calendar year.
5.5. Registration of Mobile Machine
Operations
5.5.1. In addition to the
requirements of Section
5.4, the applicant shall submit the
following information:
5.5.1.1. An established
main location where the machine(s), records, etc. will be maintained for
inspection. This shall be a street address, not a post office box
number.
5.5.1.2. If a mobile van is
used with a fixed unit inside, provide the floor plan indicating protective
shielding and the operator's location.
5.6. Registration of Healing Arts Screening
and Medical Research
5.6.1. Authorization for
healing arts screening may be granted by the Department provided the registrant
demonstrates that such healing arts screening will not result in undue
risk.
5.6.2. Each healing arts
screening program shall obtain prior written approval by the
Department.
5.6.3. In addition to
the requirements of Section
5.4, each applicant shall apply for and
receive authorization for healing arts screening before initiating a screening
program, using a separate application provided by the Department.
5.6.4. Persons requesting that the Department
approve a healing arts screening program, except for mammography, shall submit
the Department's applications, which includes but is not limited to questions
and documentation covering the following information and evaluation:
5.6.4.1. Name and address of the applicant
and, where applicable, the names and addresses of locations within Vermont
where the service will be provided.
5.6.4.2. Diseases or conditions for which the
x-ray examinations are to be used in diagnoses.
5.6.4.3. A detailed description of the x-ray
examinations proposed in the screening program (i.e., type and number of
views).
5.6.4.4. Description of the
population to be examined in the screening program, (i.e., age range, gender,
physical condition, and other appropriate information).
5.6.4.5. An evaluation of any known alternate
methods not involving ionizing radiation that could achieve the goals of the
screening program and why these methods are not used in preference to the x-ray
examinations.
5.6.4.6. An
evaluation conducted by a Qualified Expert, of the x-ray system(s) to be used
in the screening program. The evaluation shall include the following:
5.6.4.6.1. Documentation that such system(s)
satisfy all requirements of this Section; and
5.6.4.6.2. Estimation of patient entrance
skin exposures from the x-ray examinations to be performed.
5.6.4.7. A description of the
diagnostic x-ray quality control program.
5.6.4.8. Documentation of the technique
protocols for the x-ray examination procedures to be used.
5.6.4.9. The name and Vermont license number
of each health care provider who will be supervising the operators of the x-ray
system(s). The extent of supervision and the method of work performance
evaluation shall be specified.
5.6.4.10. Procedures to be used in advising
the individuals screened and their health care provider(s) of the results of
the screening procedure and any further medical needs indicated.
5.6.4.11. Procedures for the retention or
disposition of the images and other records pertaining to the x-ray
examinations.
5.6.4.12. Frequency
of screening of individuals.
5.6.4.13. The duration of the screening
program.
5.6.5. The
applicant shall immediately notify the Department if any information submitted
to the Department becomes invalid or outdated.
5.6.6. FDA/MQSA-certified facilities that are
registered with the Department for the use of dedicated mammographic equipment
for mammography screening are approved for mammography screening only and are
considered to have met the requirements of Section
5.6.1.
5.6.7. In addition to the requirements of
Section 5.4, any research using
radiation machines on humans shall be 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 practitioner of the healing arts to direct any use
of radiation in accordance with Section
8.0.
5.7. Registration of Servicing and Services
5.7.1. Each person who is engaged in the
business of installing or offering to install radiation machines or is engaged
in the business of providing or offering to provide radiation machine servicing
or services in Vermont shall apply for registration of such services with the
Department within 30 days following the effective date of this regulation or
thereafter prior to providing or offering to provide any such
services.
5.7.2. Application for
registration shall be completed on forms published by the Department and shall
contain all information required by the Department as indicated on the forms
and accompanying instructions.
5.7.3. Any individual who performs radiation
machine assembly, installation or service shall meet the following educational
and experience requirements:
5.7.3.1.
Completion of a structured educational program that includes training in
radiation machine safety, assembly, installation and service, including, but
not limited to:
5.7.3.1.1. A baccalaureate
degree in electrical engineering with specialized training in radiation
producing devices; or
5.7.3.1.2. A
one-year associate degree in biomedical equipment repair; or
5.7.3.1.3. Equivalent manufacturer, military
or other technical school training; and
5.7.3.2. For each service category requested:
5.7.3.2.1. At least 6 months of supervised,
documented training on assembly, installation and service of the applicable
radiation machine.
5.7.4. For the purposes of Section
5.7, services may include but shall not be
limited to:
5.7.4.1. Installation and/or
servicing of radiation machines and associated radiation machine
components;
5.7.4.2. Calibration of
radiation machines or radiation measurement instruments or devices;
5.7.4.3. Radiation protection, medical
physics or health physics consultations or surveys;
5.7.4.4. Personnel dosimetry services;
and
5.7.4.5. Provider of
equipment.
5.8.
Issuance of Notice of Registration
5.8.1.
Upon a determination that an applicant meets the requirements of this Rule,
including payment of any applicable fees, the Department shall issue a notice
of registration.
5.8.2. Except as
provided by Section
5.9.2, each notice of registration shall
expire at the end of the specified day in the month and year stated
therein.
5.8.3. No individual shall
perform services that are not specifically stated for that individual on the
notice of registration issued by the Department.
5.9. Renewal of Notice of Registration
5.9.1. Application for renewal of
registration shall be filed in accordance with Sections
5.4 or
5.7.
5.9.2. In any case in which a registrant not
less than 30 days prior to the expiration of their existing notice of
registration has filed an application in proper form for renewal, such existing
notice of registration shall not expire until the application status has been
finally determined by the Department.
5.10. Report of Changes The registrant shall
notify the Department in writing before making any change that would render the
information contained in the application for registration and/or the notice of
registration no longer accurate.
5.11. Approval Not Implied No person, in any
advertisement, shall refer to the fact that their facility is registered with
the Department pursuant to the provisions of Sections
5.4 or
5.7, and no person shall state or imply that
any activity under such registration has been approved by the
Department.
5.12. Assembler and/or
Transfer Obligation
5.12.1. Any person who
sells, leases, transfers, lends, disposes, assembles, or installs radiation
machines in Vermont shall notify the Department via email or written
notification within 15 days of:
5.12.1.1. The
name and address of persons who have received these machines;
5.12.1.2. The manufacturer, model, and serial
number of each radiation machine transferred; and
5.12.1.3. The date of transfer of each
radiation machine.
5.12.2. Providing the Department with a copy
of the completed FDA Form 2579 will satisfy the notification requirement
identified in 5.12.1.
5.12.3. A
person shall not make, sell, lease, transfer, lend, assemble, or install
radiation machines, or the supplies used for such machines, that do not meet
the requirements of this Rule.
5.13. Reciprocal Recognition of Out-of-State
Machines
5.13.1. Whenever any radiation
machine is to be brought into Vermont, for any temporary use, the person
proposing to bring such machine into Vermont shall give written notice to the
Department at least 3 working days before such machine is to be used in
Vermont. The notice shall include:
5.13.1.1.
The type of radiation machine;
5.13.1.2. The nature, duration, and scope of
use;
5.13.1.3. The exact
location(s) where the radiation machine is to be used; and
5.13.1.4. States in which this machine is
registered.
5.13.2. If,
for a specific case, the 3 working-day period would impose an undue hardship on
the person, upon application to the Department, permission to proceed sooner
may be granted.
5.13.3. The person
referred to in Section
5.13.1 shall:
5.13.3.1. Comply with all applicable
regulations of the Department;
5.13.3.2. Supply the Department with such
other information as the Department may reasonably request; and
5.13.3.3. Not operate within Vermont on a
temporary basis in excess of 180 calendar days per year.
5.14. Certification of Qualified
Medical Physicists for Registration
5.14.1.
All persons registered to provide medical physics services shall be certified
by at least one of the organizations in the appropriate fields or specialties
in which services are provided. A list of the subfields and the recognized
national certifying bodies can be found on the Department's website.
6.0
Inspections.
6.1. All regulated entities who
receive, possess, use, or transfer sources of ionizing radiation shall:
6.1.1. Permit the Department at all times the
opportunity to inspect and evaluate sources of radiation and the premises and
facilities wherein such sources of radiation are used or stored, and shall make
available pertinent data, as well as records and reports as may be required by
the Department.
6.1.2. Grant the
Department access to all records pertaining to the radiological health and
safety of employees, and to any effect of the operation of the facility upon
the environment.
6.1.3. Permit the
Department to make unscheduled visits to the regulated facility for the purpose
of obtaining samples and surveys for analysis.
7.0 Standards for Protection Against
Radiation.
7.1. Radiation Protection Programs
7.1.1. Each registrant shall develop,
document, and implement a radiation protection program sufficient to ensure
compliance with the provisions of Section
7.0. See 7.10 for recordkeeping requirements
relating to these programs.
7.1.2.
The registrant shall use, to the extent practical, procedures and engineering
controls based upon sound radiation protection principles to achieve
occupational doses and doses to members of the public that are as low as is
reasonably achievable (ALARA).
7.1.3. The registrant shall, at intervals not
to exceed 1 year, review the radiation protection program content and
implementation.
7.2.
Occupational Dose Limits for Adults
7.2.1.
The registrant shall control the occupational dose to individual adults, except
for planned special exposures pursuant to 7.3, to the following dose limits:
7.2.1.1. An annual limit, which is the more
limiting of:
7.2.1.1.1. The total effective
dose equivalent being equal to 0.05 Sv (5 rem); or
7.2.1.1.2. The sum of the deep dose
equivalent and the committed dose equivalent to any individual organ or tissue
other than the lens of the eye being equal to 0.5 Sv (50 rem).
7.2.1.2. The annual limits to the
lens of the eye, to the skin of the whole body, and to the skin of the
extremities, which are:
7.2.1.2.1. A lens dose
equivalent of 0.15 Sv (15 rem); and
7.2.1.2.2. A shallow dose equivalent of 0.5
Sv (50 rem) to the skin of the whole body or to the skin of any
extremity.
7.2.2. Doses received in excess of the annual
limits, including doses received during accidents, emergencies, and planned
special exposures, shall be subtracted from the limits for planned special
exposures that the individual may receive during the current calendar year and
during the individual's lifetime, as specified in
10 CFR
20.1206.
7.2.3. The registrant shall reduce the dose
that an individual may be allowed to receive in the current year by the amount
of occupational dose received while employed by any other person.
7.2.4. Assigned dose equivalent
7.2.4.1. When the external exposure is
determined by measurement with an external personal monitoring device, the
deep-dose equivalent must be used in place of the effective dose equivalent.
7.2.4.2. The deep-dose equivalent,
lens dose equivalent, and shallow dose equivalent may be assessed from surveys
or other radiation measurements for the purpose of demonstrating compliance
with the occupational dose limits, if the individual monitoring device was not
in the region of highest potential exposure, or the results of individual
monitoring are unavailable.
7.2.4.3. For sources of radiation other than
radioactive material, when a protective apron is worn and monitoring is
conducted, the effective dose equivalent for external radiation shall be
determined as follows:
7.2.4.3.1. When only
one individual monitoring device is used and it is located at the neck outside
the protective apron, and the reported dose exceeds 25% of the limit specified
in 7.2.1, the reported deep dose equivalent value multiplied by 0.3 shall be
the effective dose equivalent for external radiation; or
7.2.4.3.2. When individual monitoring devices
are worn, both under the protective apron at the waist and outside the
protective apron at the neck, the effective dose equivalent for external
radiation shall be assigned the value of the sum of the deep dose equivalent
reported for the individual monitoring device located at the waist under the
protective apron multiplied by 1.5 and the deep dose equivalent reported for
the individual monitoring device located at the neck outside the protective
apron multiplied by 0.04.
7.3. Planned Special Exposures for Adults
7.3.1. A registrant may authorize an adult
worker to receive doses in addition to and accounted for separately from the
doses received under the limits specified in 7.2 provided that each of the
following conditions is satisfied:
7.3.1.1.
The registrant authorized a planned special exposure only in an exceptional
situation when alternatives that might avoid the dose estimated to result from
the planned special exposure are unavailable or impractical.
7.3.1.2. The registrant, and the employer if
the employer is not the registrant, specifically authorizes the planned special
exposure, in writing, before the exposure occurs.
7.3.1.3. Before a planned special exposure,
the registrant provides in writing to each individual involved:
7.3.1.3.1. Information regarding the purpose
of the planned operation; and
7.3.1.3.2. Information regarding the
estimated doses and associated potential risks and specific radiation levels or
other conditions that might be involved in performing the task; and
7.3.1.3.3. Instructions regarding the
measures to be taken to keep the dose ALARA considering other risks that may be
present.
7.3.2.
Prior to permitting an individual to participate in a planned special exposure,
the registrant ascertains prior occupational doses during the lifetime of the
individual for each individual involved.
7.3.3. Subject to 7.2.2, the registrant shall
not authorize a planned special exposure that would cause an individual to
receive a dose from all planned special exposures and all doses in excess of
the limits to exceed:
7.3.3.1. The numerical
values of any of the dose limits in 7.2.1 in any year; and
7.3.3.2. Five times the annual dose limits in
7.2.1 during the individual's lifetime.
7.3.4. The registrant maintains records of
the conduct of a planned special exposure in accordance with 7.11 and submits a
written report in accordance with 7.16.
7.3.5. The registrant records the best
estimate of the dose resulting from the planned special exposure in the
individual's record and informs the individual, in writing, of the dose within
30 days from the date of the planned special exposure. The dose from planned
special exposures shall not be considered in controlling future occupational
dose of the individual pursuant to 7.2.1 but shall be included in evaluations
required by 7.3.2 and 7.3.3.
7.4. Occupational Dose Limits for Minors The
annual occupational dose limits for minors are 10 percent of the annual
occupational dose limits specified for adult workers in 7.2.1.
7.5. Dose Equivalent to an Embryo/Fetus
7.5.1. The registrant shall ensure that the
dose equivalent to an embryo/fetus during the entire pregnancy, due to the
occupational exposure of a declared pregnant worker, does not exceed 5 mSv (0.5
rem).
7.5.2. The registrant shall
make efforts to avoid substantial variation above a uniform monthly exposure
rate to a declared pregnant worker so as to satisfy the limit in
7.5.1.
7.5.3. If the dose
equivalent to the embryo/fetus is found to have exceeded 5 mSv (0.5 rem), or is
within 0.5 mSv (0.05 rem) of this dose, by the time the worker declares the
pregnancy to the registrant, the registrant shall be deemed to be in compliance
with 7.5.1 if the additional dose equivalent to the embryo/fetus does not
exceed 0.5 mSv (0.05 rem) during the remainder of the pregnancy.
7.5.4. An individual monitoring device used
for the dose to an embryo/fetus of a declared pregnant worker wearing a
protective apron shall be located under the protective apron at the
waist.
7.6. Dose Limits
for Individual Members of the Public
7.6.1.
Each registrant shall conduct operations so that:
7.6.1.1. The total effective dose equivalent
to individual members of the public from the registered operation does not
exceed 1 mSv (0.1 rem) in a calendar year, exclusive of the dose contributions
from background radiation, from any medical administration the individual has
received, from exposure to individuals administered radioactive material and
released, and from voluntary participation in medical research programs;
and
7.6.1.2. The dose in any
unrestricted area from external sources, exclusive of the dose contributions
from patients administered radioactive material and released, does not exceed
0.02 mSv (0.002 rem) in any one hour.
7.7. Surveys and Monitoring
7.7.1. Each registrant shall make, or cause
to be made, surveys of areas that:
7.7.1.1.
Are necessary for the registrant to comply with Section
7.0; and
7.7.1.2. Are necessary under the
circumstances to evaluate:
7.7.1.2.1. The
magnitude and extent of radiation levels; and
7.7.1.2.2. The potential radiological
hazards.
7.7.2.
The registrant shall ensure that instruments and equipment used for
quantitative radiation measurements are calibrated at intervals consistent with
the guidance provided by the manufacturer, but not to exceed 2 years (24
months) unless otherwise noted in this Rule.
7.7.3. All personnel dosimeters, except for
direct and indirect reading pocket ionization chambers and those dosimeters
used to measure the dose to any extremity, that require processing to determine
the radiation dose and that are used by registrants to comply with 7.2.1, shall
be processed and evaluated by a dosimetry processor:
7.7.3.1. Holding current personnel dosimetry
accreditation from the National Voluntary Laboratory Accreditation Program
(NVLAP) of the National Institute of Standards and Technology; and
7.7.3.2. Approved in this accreditation
process for the type of radiation included in the NVLAP program that most
closely approximates the type of radiation for which the individual wearing the
dosimeter is monitored.
7.7.4. The registrant shall ensure that
adequate precautions are taken to prevent a deceptive exposure of an individual
monitoring device.
7.8.
Conditions Requiring Individual Monitoring of Occupational Dose
7.8.1. Each registrant shall monitor
occupational exposure to radiation from sources under the control of the
registrant and shall supply and require the use of individual monitoring
devices by:
7.8.1.1. Adults likely to receive,
in 1 year from sources external to the body, a dose in excess of 10 percent of
the limits in 7.2.1.
7.8.1.2.
Minors likely to receive, in 1 year from sources external to the body, a deep
dose equivalent in excess of 1 mSv (0.1 rem), a lens dose equivalent in excess
of 1.5 mSv (0.15 rem), or a shallow dose equivalent to the skin or to the
extremities in excess of 5 mSv (0.5 rem);
7.8.1.3. Declared pregnant workers likely to
receive during the entire pregnancy, from sources external to the body, a deep
dose equivalent in excess of 1 mSv (0.1 rem); and
7.8.1.4. Individuals entering a high
radiation area or a very high radiation area.
7.8.2. Upon written approval of the
Department, an acceptable alternative to the use of continuous individual
monitoring devices in order to demonstrate compliance with 7.8.1 may be used.
7.8.2.1. Acceptable alternative
demonstrations that doses will not exceed 10 percent of the annual limits in
7.2.1, 7.4, and 7.5 include submittal to the Department of:
7.8.2.1.1. An acceptable documentation for
six months of the use of continuous individual monitoring devices; or
7.8.2.1.2. An acceptable assessment from the
appropriate Qualified Expert that takes into account design configuration,
workload, radiation-producing machine output, and survey data.
7.8.2.2. To maintain approval of
an acceptable alternative to the use of continuous individual monitoring
devices:
7.8.2.2.1. Documentation under
7.8.2.1.1 or reassessment under
7.8.2.1.2 is
required for any change in configuration, equipment, or workload; and
7.8.2.2.2. The registrant shall
include assessment of individual monitoring in the review of the radiation
protection program required annually by 7.1.
7.9. Storage and Control of
Radiation-Producing Machines
7.9.1. The
registrant shall secure from unauthorized removal or access radiation-producing
machines, including those that are stored in unrestricted areas.
7.9.2. The registrant shall maintain control
of radiation-producing machines that are in an unrestricted area and that are
not in storage.
7.10.
Records of Radiation Protection Programs
7.10.1. Each registrant shall maintain
records of the radiation protection program, including:
7.10.1.1. The provisions of the program;
and
7.10.1.2. Audits and other
reviews of program content and implementation.
7.10.2. The registrant shall retain the
records required by 7.10.1.1 until the registration requiring the record is
terminated. The registrant shall retain the records required by 7.10.1.2 for
three years after the record is made.
7.11. Records of Planned Special Exposures
7.11.1. For each use of the provisions of 7.3
for planned special exposures, the registrant shall maintain records that
describe:
7.11.1.1. The exceptional
circumstances requiring the use of a planned special exposure;
7.11.1.2. The name of the management official
who authorized the planned special exposure and a copy of the signed
authorization;
7.11.1.3. What
actions were necessary;
7.11.1.4.
Why the actions were necessary;
7.11.1.5. What precautions were taken to
ensure that doses were maintained ALARA;
7.11.1.6. What individual and collective
doses were expected to result; and
7.11.1.7. The doses actually received in the
planned special exposure.
7.11.2. The registrant shall retain the
records until the registration requiring these records is terminated.
7.12. Records of Individual
Monitoring Results
7.12.1. Each registrant
shall maintain records of doses received by all individuals for whom monitoring
was required pursuant to 7.8, and records of doses received during planned
special exposures, accidents, and emergency conditions. These records shall
include, when applicable, the deep dose equivalent to the whole body, lens dose
equivalent, shallow dose equivalent to the skin, and shallow dose equivalent to
the extremities.
7.12.2. The
registrant shall make entries of the records specified in 7.12.1 at intervals
not to exceed one year.
7.12.3. The
registrant shall maintain the records of dose to an embryo/fetus with the
records of dose to the declared pregnant worker. The declaration of pregnancy,
including the estimated date of conception, shall also be kept on file, but may
be maintained separately from the dose records.
7.12.4. The registrant shall retain each
required record until the registration requiring these records is
terminated.
7.13. Reports
of Stolen, Lost, or Missing Radiation-Producing Machines
7.13.1. Telephone Reports
7.13.1.1. Each registrant shall report by
telephone to the Department that a radiation machine has been stolen, lost, or
missing immediately upon knowledge of such an occurrence.
7.13.2. Written Reports
7.13.2.1. Each registrant required to make a
report pursuant to 7.13.1.1 shall, within 30 days after making the telephone
report, make a written report to the Department setting forth the following
information:
7.13.2.1.1. A description of the
radiation machine involved, including the manufacturer, model and serial
number, type and maximum energy of radiation emitted:
7.13.2.1.2. A description of the
circumstances under which the loss or theft occurred;
7.13.2.1.3. A statement of disposition, or
probably disposition, of the radiation machine involved;
7.13.2.1.4. Exposures of individuals to
radiation, circumstances under which the exposures occurred, and the possible
total effective dose equivalent to persons in unrestricted areas;
7.13.2.1.5. Actions that have been taken, or
will be taken, to recover the radiation machine; and
7.13.2.1.6. Procedures or measures that have
been, or will be, adopted to ensure against a recurrence of the loss or theft
of radiation machines.
7.13.2.2. Subsequent to filing the written
report, the registrant shall also report additional substantive information on
the loss or theft within 30 days after the registrant learns of such
information.
7.13.2.3. The
registrant shall prepare any report filed with the Department pursuant to 7.13
so that names of individuals who may have received exposure to radiation are
stated in a separate and detachable portion of the report.
7.14. Notification of Incidents
7.14.1. Immediate Notification.
Notwithstanding other requirements for notification, each registrant shall
notify the Department as soon as possible but no later than 4 hours after the
discovery of an event:
7.14.1.1. Involving a
radiation machine possessed by the registrant that may have caused or threatens
to cause an individual to receive:
7.14.1.1.1.
A total effective dose equivalent of 0.25 Sv (25 rem) or more;
7.14.1.1.2. A lens dose equivalent of 0.75 Sv
(75 rem) or more; or
7.14.1.1.3. A
shallow dose equivalent to the skin or extremities or a total organ dose
equivalent of 2.5 Gy (250 rad) or more.
7.14.1.2. That prevents immediate protective
actions necessary to avoid exposures to radiation that could exceed regulatory
limits.
7.14.2.
Twenty-four Hour Notification. Each registrant shall, within 24 hours of
discovery of the event, report to the Department:
7.14.2.1. Each event involving loss of
control of a radiation machine possessed by the registrant that may have
caused, or threatens to cause, an individual to receive, in a period of 24
hours:
7.14.2.1.1. A total effective dose
equivalent exceeding 0.05 Sv (5 rem); or
7.14.2.1.2. A lens dose equivalent exceeding
0.15 Sv (15 rem); or
7.14.2.1.3. A
shallow dose equivalent to the skin or extremities or a total organ dose
equivalent exceeding 0.5 Sv (50 rem).
7.14.2.2. An event in which equipment is
disabled or fails to function as designed when:
7.14.2.2.1. The equipment is required by
regulation to prevent exposures to radiation exceeding regulatory limits, or to
mitigate the consequences of an accident;
7.14.2.2.2. The equipment is required to be
available and operable when it is disabled or fails to function during the
event; and
7.14.2.2.3. No redundant
equipment is available and operable to perform the required safety
function.
7.15. Preparation and Submission of Reports
7.15.1. Reports made by registrants in
response to the requirements of 7.14 must be made as follows:
7.15.1.1. Registrants shall make the reports
required by 7.14.1 and 7.14.2 to the Department by telephone or email. To the
extent that the information is available at the time of notification, the
information provided in these reports must include:
7.15.1.1.1. The name of the person making the
report and their call-back telephone number;
7.15.1.1.2. A description of the event,
including time and date;
7.15.1.1.3. The exact location of the event;
and
7.15.1.1.4. Any personnel
radiation exposure data available.
7.15.1.2. Each registrant who makes a report
required by 7.14.1 and 7.14.2 shall submit a written follow-up report to the
Department pursuant to 7.15.3 within 30 days of the initial report. Written
reports prepared pursuant to other regulations may be submitted to fulfill this
requirement if the reports contain all of the necessary information and the
appropriate distribution is made.
7.15.1.3. The provisions of 7.14 do not apply
to doses that result from planned special exposures, provided such doses are
within the limits for planned special exposures and are reported pursuant to
7.16.
7.15.2. In addition
to the notification required by 7.14, each registrant shall submit a written
report to the Department within 30 days after learning of doses in excess of
any of the following:
7.15.2.1. The
occupational dose limits for adults in 7.2;
7.15.2.2. The occupational dose limits for a
minor in 7.4;
7.15.2.3. The limits
for an embryo/fetus of a declared pregnant person in 7.5; or
7.15.2.4. The limits for an individual member
of the public in 7.6.
7.15.3. Contents of Written Reports
7.15.3.1. Each report required by 7.15.1.2 or
7.15.2 shall include the following, as appropriate:
7.15.3.1.1. A description of the event,
including the possible cause and the manufacturer and model number (if
applicable) of any equipment that failed or malfunctioned;
7.15.3.1.2. The exact location of the
event;
7.15.3.1.3. Date and time of
the event; and
7.15.3.1.4. The
results of any evaluations or assessments, including:
7.15.3.1.4.1. Estimates of each individual's
dose;
7.15.3.1.4.2. The levels of
radiation involved;
7.15.3.1.4.3.
The cause of the elevated exposures or dose rates; and
7.15.3.1.4.4. Corrective steps taken or
planned to ensure against a recurrence, including the schedule for achieving
conformance with applicable limits and ALARA constraints.
7.15.3.2. Each report filed
pursuant to 7.15 shall include for each occupationally overexposed individual:
the name, Social Security account number, and date of birth. With respect to
the limit for the embryo/fetus in 7.5, the identifiers should be those of the
declared pregnant person. The report shall be prepared so that this information
is stated in a separate and detachable portion of the report and must be
clearly labeled "Privacy Act Information: Not for Public Disclosure."
7.16. Reports of Planned
Special Exposures
The registrant shall submit a written report to the Department within 30 days following any planned special exposure conducted in accordance with 7.3, informing the Department that a planned special exposure was conducted and indicating the date the planned special exposure occurred and the information required by 7.11.
7.17. Posting of Notices to Workers
7.17.1. Each registrant shall post current
copies of the following documents:
7.17.1.1.
The Vermont Radiological Health Rule;
7.17.1.2. The certificate of
registration;
7.17.1.3. The
operating procedures applicable to activities under the registration;
and
7.17.1.4. Any notice of
violation involving radiological working conditions, proposed imposition of
civil penalty, or order issued pursuant to these regulations, and any response
from the registrant.
7.17.2. If posting of a document specified in
7.17.1.1 or 7.17.1.3 is not practicable, the registrant may post a notice which
describes the document and states where it may be examined.
7.17.3. Department documents posted pursuant
to 7.17.1.4 shall be posted within 5 working days after receipt of the
documents from the Department; the registrant's response, if any, shall be
posted within 5 working days after dispatch from the registrant.
7.17.3.1. Such documents shall remain posted
for a minimum of 5 working days or until action correcting the violation has
been completed, whichever is later.
7.17.4. Documents, notices, or forms posted
pursuant to 7.17 shall appear in a sufficient number of places to permit
individuals engaged in work under the registration to observe them on the way
to or from any particular work location to which the document applies, shall be
conspicuous, and shall be replaced if defaced or altered.
7.18. Instructions to Workers
7.18.1. All individuals who in the course of
employment are likely to receive in a year an occupational dose in excess of 1
mSv (100 mrem) shall be:
7.18.1.1. Kept
informed of the storage, transfer, or use of sources of radiation;
7.18.1.2. Instructed in the health protection
problems associated with exposure to radiation to the individual and potential
offspring, in precautions or procedures to minimize exposure, and in the
purposes and functions of protective devices employed;
7.18.1.3. Instructed in, and required to
observe, to the extent within the worker's control, the applicable provisions
of these regulations for the protection of personnel from exposures to
radiation;
7.18.1.4. Instructed of
their responsibility to report promptly to the registrant any condition which
may constitute, lead to, or cause a violation of these regulations, or
unnecessary exposure to radiation;
7.18.1.5. Instructed in the appropriate
response to warnings made in the event of any unusual occurrence or malfunction
that may involve exposure to radiation; and
7.18.1.6. Advised as to the radiation
exposure reports which workers shall be provided pursuant to 7.12.
7.18.2. In determining those
individuals subject to the requirements of 7.18.1, registrants must take into
consideration assigned activities during normal and abnormal situations
involving exposure to radiation which can reasonably be expected to occur at a
registered facility. The extent of these instructions shall be commensurate
with potential radiological health protection problems present in the
workplace.
7.19.
Notification and Reports to Individuals
7.19.1. Radiation exposure data for an
individual shall be reported to the individual as specified in this section.
7.19.1.1. Each notification and report shall:
7.19.1.1.1. Be in writing;
7.19.1.1.2. Include appropriate identifying
data such as the name of the registrant, the name of the individual, and the
individual's identification number; and
7.19.1.1.3. Include the individual's exposure
information.
7.19.2. Each registrant shall provide to each
monitored worker at least annually a written report of the worker's dose as
shown in records maintained by the registrant, consistent with the requirements
of 7.8.
7.19.3. Each registrant
shall provide a report of the worker's exposure to sources of radiation at the
request of a worker formerly engaged in activities controlled by the
registrant.
7.19.3.1. The report shall include
the dose record for each year the worker was required to be
monitored.
7.19.3.2. Such report
shall be provided within 30 days from the date of the request or within 30 days
after the dose of the individual has been determined by the registrant,
whichever is later.
7.19.3.3. The
report shall cover the period of time the worker's activities involved exposure
to sources of radiation and shall include the dates and locations of work under
the registration in which the worker participated.
7.19.4. At the request of a worker who is
terminating employment with the registrant in work involving exposure to
radiation during the current calendar year, each registrant shall provide at
termination to each such worker a written report regarding the radiation dose
received by that worker from operations of the registrant during the current
calendar year.
7.19.4.1. If the most recent
individual monitoring results are not available at that time, a written
estimate of the dose shall be provided together with a clear indication that
this is an estimate.
8.0 X-Ray Imaging in the Healing Arts and
Veterinary Medicine.
8.1. Purpose and Scope
8.1.1. This Section establishes requirements,
for which the registrant is responsible, for use of diagnostic and
interventional x-ray equipment and imaging systems by, or under the supervision
of, an individual authorized by, and licensed in accordance with, State of
Vermont regulations to engage in the healing arts or veterinary
medicine.
8.1.2. The provisions of
this Section are in addition to, and not in substitution for, other applicable
provisions of this Rule.
8.2. Administrative Controls
8.2.1. Each radiation machine used in the
healing arts or veterinary medicine in the State of Vermont shall be registered
with the Department as required by Section
5.4.
8.2.2. The registrant shall be responsible
for directing the operation of the x-ray system(s) under their administrative
control. The registrant shall ensure that the requirements of this Section are
met in the operation of the x-ray system(s).
8.2.3. Each radiation machine used on humans
shall meet the Federal Performance Standards, Subchapter J - Radiological
Health, 21 CFR
1020.30 through
1020.33.
8.2.3.1. X-ray imaging systems and their
associated components, certified pursuant to
21 CFR
1020.30 through
1020.33, shall be maintained in
compliance with applicable requirements of
21 CFR
1020.30 through
1020.33.
8.2.3.2. Diagnostic x-ray components and
systems certified in accordance with
21 CFR
1020.30 through
1020.33 shall not be modified such
that the component or system fails to comply with any applicable requirement of
21 CFR Part 1020 or this Rule.
8.2.3.3. The registrant shall keep a record
of the date, service provider, and details of each component or system
modification.
8.2.3.4. Limited
exemption from this requirement may be granted by the Department for a
radiation machine manufactured prior to August 4, 1974, provided the registrant
demonstrates that such exemption will not result in undue risk.
8.2.3.5. An x-ray system which does not meet
the provisions of this Section shall not be operated for diagnostic
purposes.
8.2.4. The
registrant shall use approved providers of services, consistent with Section
5.7, including but not limited to operation
of equipment; inspection of radiation machines and facilities; and assembly,
installation, service, and/or calibration of radiation machines.
8.2.5. A radiation machine which does not
meet the provisions of this Rule shall not be operated for diagnostic purposes
unless the Department determines that the non-compliance shall not pose a
significant risk or significantly affect image quality, and arrangements have
been made to correct the non-compliance within 30 days.
8.2.6. Individuals who will be operating the
radiation machine for healing arts or veterinary medicine use shall possess a
current State of Vermont professional license, when applicable, in accordance
with State licensing requirements.
8.2.6.1.
Use of a radiation machine in the healing arts shall be by or under the general
supervision of a Vermont-licensed veterinarian, physician, chiropractor,
dentist, podiatrist, or other Vermont-licensed health care practitioner
authorized to do so within their scope of practice.
8.2.6.2. The names and licenses of all
personnel operating radiation machines for healing arts must be kept on file
for Department inspection at each facility location.
8.3. Written Technique Information
8.3.1. Written technique information shall be
readily accessible to the operator. This requirement may also be met if
anatomically programmable controls are used.
8.3.2. For all examinations performed with
the radiation machine, the following technique information shall be provided:
8.3.2.1. Patient's body part and anatomical
size, or body part thickness, or age (for pediatrics), versus technique factors
to be utilized;
8.3.2.2. Equivalent
manual technique information if Automatic Exposure Control (AEC) is not
available;
8.3.2.3. Type and size
of the image receptor combination to be used, if any; and
8.3.2.4. Source to image receptor distance to
be used (except for dental intraoral radiography).
8.4. Written Safety Procedures
8.4.1. The registrant of a facility shall
create and make available to x-ray operators written safety procedures,
including patient holding and any restrictions of the operating technique
required for the safe operation of the particular radiation machine. The
operator shall be able to demonstrate familiarity with these
procedures.
8.4.2. When a patient
or image receptor must be provided with auxiliary support during a radiation
exposure:
8.4.2.1. The written safety
procedures shall list individual projections for where holding devices cannot
be utilized; and
8.4.2.2. Written
safety procedures shall indicate the requirements for selecting a holder and
the procedure the holder shall follow.
8.5. General Specifications for Facility
Design, Configuration, and Preparation
8.5.1.
Evaluation of Shielding Design Prior to Commencement of Operation
8.5.1.1. The floor plan and equipment
configuration of a radiation machine facility shall be designed to meet all
applicable requirements of this Rule and in particular to preclude an
individual from receiving a dose in excess of the limits in Sections
7.2 through
7.6.
8.5.1.2. The floor plan and equipment
configuration of each radiation machine facility shall be provided to a
Qualified Expert who designs or evaluates shielding, for determination of
shielding requirements in accordance with the Department's Shielding Design
Requirements guidance document. These submittals shall include:
8.5.1.2.1. The normal location of the x-ray
imaging system's radiation port; the port's travel and traverse limits; general
direction(s) of the useful beam; locations of any windows and doors; the
location of the operator's booth; and the location of the x-ray control
panel.
8.5.1.2.2. The structural
composition and thickness of all walls, doors, partitions, floor, and ceiling
of the room(s) concerned, if that information is available.
8.5.1.2.3. The dimensions of the room(s)
concerned and inter-floor distances if space above or below is
occupied.
8.5.1.2.4. The type of
occupancy of all adjacent areas inclusive of space above and below the room(s)
concerned.
8.5.1.2.5. If there is
an exterior wall, the distance to the closest area(s) where it is likely that
individuals may be present.
8.5.1.2.6. A description of the x-ray imaging
system and components, including the make and model of the equipment.
8.5.1.2.7. The type of examination(s) or
treatment(s) that will be performed with the equipment.
8.5.1.2.8. Information on the anticipated
workload of the x-ray imaging system(s).
8.5.1.3. The shielding design by a Qualified
Expert, required by Section
8.5.1.2, shall be completed and
submitted to the Department prior to:
8.5.1.3.1. Construction of a new radiation
machine facility;
8.5.1.3.2. Any
renovation or modification of an existing radiation machine facility that has a
potential to reduce the effectiveness of existing shielding from x-ray
radiation; or
8.5.1.3.3.
Installation of a new radiation machine in an existing
facility.
8.5.1.4. A
Qualified Expert who completes the shielding design required by Section
8.5.1.2 shall provide the shielding
design to the radiation machine facility registrant, including the dimensional
drawing specified by Section
8.5.3.
8.5.1.5. The facility registrant shall
construct the shielding and configure the equipment in accordance with the
recommendation(s) provided by the Qualified Expert pursuant to Section
8.5.1.4.
8.5.2. Evaluation of Shielding Design After
Commencement of Operations
8.5.2.1. A
Qualified Expert shall review and modify shielding design, consistent with
Section 8.5.1 and the
Department's Shielding Design Requirements guidance document, whenever:
8.5.2.1.1. An inspection or a survey during
operation shows that a dose in excess of a limit in Sections
7.2 through
7.6 is possible;
8.5.2.1.2. An existing radiation machine
facility is to be modified such that the existing shielding might be
inadequate;
8.5.2.1.3. The useful
beam orientation is changed;
8.5.2.1.4. The primary shielding is altered
due to the modification or renovation of a facility;
8.5.2.1.5. Mobile or non-handheld portable
x-ray equipment is to be used regularly in the same location;
8.5.2.1.6. Radiation machine workload (for
example, mA-minute-per-week workload) has increased or is projected to increase
above that which was the basis for the original shielding design; or
8.5.2.1.7. The registrant is unable to
produce for inspection a written shielding design completed in accordance with
Section 8.5.1 and/or Section
8.5.2, as is
applicable.
8.5.2.2. If
Qualified Expert analysis of operating conditions required by Section
8.5.2.1 indicates that an individual is
likely to receive a dose in excess of the limits in Sections
7.2 through
7.6, then the facility registrant shall
modify the shielding and/or equipment configuration in accordance with the
recommendation(s) of the Qualified Expert.
8.5.3. The registrant shall retain, for each
room in which a stationary x-ray imaging system is located, a current
dimensional drawing that includes indication of the:
8.5.3.1. Use of each area adjacent to the
room and an estimation of the extent of occupancy in each such area;
and
8.5.3.2. Results by a Qualified
Expert from calculation(s) for the type and thickness of material(s) in each
protective barrier (for example, lead equivalency);
8.5.3.2.1. After installation and prior to
commencement of operation, consistent with Section
8.5.1; and
8.5.3.2.2. Whenever shielding is modified,
consistent with Section
8.5.2.
8.5.3.3. If the registrant is unable to
produce from inspection the calculation(s) required by Section
8.5.3.2, results from survey(s)
conducted by a Qualified Expert to determine radiation levels present under
specified test conditions at the operator's position and at cognizable points
outside the room.
8.5.4.
Unless exempted in accordance with Section
5.3.5, for each x-ray imaging system for
which a shielding design is required, the registrant shall maintain the
following for inspection:
8.5.4.1. The
installation as-built drawing(s); and
8.5.4.2. A signed statement by the registrant
that all floor plan and equipment configuration specifications in any
applicable written shielding designs required by Section
8.5 were explicitly
followed.
8.6.
Design Requirements for Diagnostic X-Ray Systems
8.6.1. In addition to other requirements of
this Section, all diagnostic x-ray systems shall meet the requirements of
Section 8.6, except as provided
by Section
8.14 for dental uses and Section
8.16 for veterinary uses.
8.6.2. Diagnostic x-ray systems and their
associated components used on humans and certified pursuant to the Federal
X-ray Equipment Performance Standard (21 CFR Part 1020) shall be maintained in
compliance with applicable requirements of that standard.
8.6.3. Each diagnostic x-ray imaging system
shall meet the following equipment design and configuration requirements, in
addition to complying with the requirements of
21 CFR
1020.30:
8.6.3.1. Beam Quality
8.6.3.1.1. Beryllium window tubes, except
those used for mammography, shall have a minimum of 0.5 millimeter aluminum
equivalent filtration permanently installed in the useful beam.
8.6.3.1.2. The required minimal aluminum
equivalent filtration shall include the filtration contributed by all materials
that are always present between the source and the patient.
8.6.3.1.3. For x-ray systems that have
variable kVp and variable filtration for the useful beam, a filtration control
device shall prevent an exposure unless the minimum amount of filtration
required by 21 CFR
1020.30(m)(1) is in the
useful beam for the given kVp that has been selected.
8.6.3.2. Tube Heads
8.6.3.2.1. The tube housing assembly supports
shall be adjusted such that the tube housing assembly will remain stable during
an exposure unless tube housing movement is a designed function of the x-ray
system.
8.6.3.2.2. Any information
displayed at the tube head shall meet the manufacturer's
specifications.
8.6.3.3.
Locks
8.6.3.3.1. All position locking,
holding, and centering devices on the x-ray system and/or components shall
function as designed.
8.6.3.4. The x-ray control shall provide:
8.6.3.4.1. Visual indication observable at or
from the operator's protected position whenever x-rays are produced;
and
8.6.3.4.2. A signal audible to
the operator to indicate that the exposure has terminated.
8.6.3.5. Modification of Certified Diagnostic
X-ray Components and Systems
8.6.3.5.1.
Diagnostic x-ray components and systems certified in accordance with 21 CFR.
Part 1020 shall not be modified such that the component or system fails to
comply with any applicable provision of this regulation unless a variance in
accordance with 21 CFR
1010.4 or an exemption under §534(a)(5) or §538(b) of the Federal Food,
Drug, and Cosmetic Act has been granted.
8.6.3.5.2. The owner of a diagnostic x-ray
system who uses the system in a professional or commercial capacity may modify
the system, provided the modification does not result in the failure of the
system or component to comply with the applicable requirements of this Rule.
The owner who causes such modification need not submit the reports required by
this Rule, provided the owner records the date and the details of the
modification in the system records and maintains this information, and provided
the modification of the x-ray system does not result in a failure to comply
with this Rule.
8.7. Measurements, Maintenance, and Design
Records
8.7.1. The registrant shall maintain
for inspection by the Department records for the previous 5 years of survey
measurements, calibrations, maintenance, modifications, certification
evaluations, and corrective actions for each x-ray imaging system with the
names of persons who performed such services.
8.7.2. The registrant shall retain a
dimensional drawing and accompanying calculation(s) and/or survey(s) as
required by Section
8.5.3 for each room in which a stationary
x-ray system is located, except as exempted under Section
5.3.5.
8.7.3. The registrant shall retain on file at
the facility for the life of the facility each shielding design along with
installer as-built drawings.
8.8. Room Occupancy During Radiographic
Exposure
8.8.1. Except for patients who cannot
be moved out of the room, only the staff, or other persons required for the
medical procedure or training (e.g. a caregiver) shall be in the room during
the radiographic exposure. Other than the patient being examined:
8.8.1.1. All individuals shall be positioned
such that no part of the body will be struck by the useful beam unless
protected by lead equivalent material. If lead equivalent material for
protection would interfere with the procedure, then dosimetry shall be used
instead.
8.8.1.2. The x-ray
operator, other staff, ancillary personnel and other persons required for the
medical procedure shall be protected from the direct scatter radiation by
protective aprons or whole body protective barriers of not less than 0.25
millimeter lead equivalent material.
8.8.1.3. Human patients who cannot be removed
from the room shall be protected from the direct scatter radiation by whole
body protective barriers of not less than 0.25 millimeter lead equivalent or
shall be so positioned that the nearest portion of the body is at least 2
meters from both the tube head and the person being imaged.
8.8.1.4. Written safety procedures, as
required by Section
8.4.1, shall describe how the requirements
of this Section will be met when using mobile or portable x-ray
systems.
8.9.
Control of Radiation Exposure
8.9.1. Exposure
under this Section of any human being to the useful beam shall be solely for
healing arts purposes and only after such exposure has been authorized by a
Vermont-licensed physician, chiropractor, dentist, podiatrist, or other
Vermont-licensed health care practitioner authorized to do so within their
scope of practice.
8.9.1.1. Deliberate
exposure of any human being for training, demonstration, or other
non-healing-arts purposes is strictly prohibited, unless specifically permitted
in writing by the Department.
8.9.2. To reduce direct radiation exposure,
individual shielding shall be available for all modalities (except for a case
in which shielding would interfere with the gonad, thyroid, dental, or other
diagnostic procedure).
8.9.3. In a
case where the patient must hold the image receptor (except during an intraoral
dental examination), any portion of the body other than the area of clinical
interest struck by the useful beam shall be protected by not less than 0.5
millimeter lead equivalent material.
8.9.4. Each individual, other than the
patient being examined, shall be positioned such that no part of the body will
be struck by the useful beam unless protected by a minimum of 0.5 millimeter
lead equivalent.
8.9.5. To reduce
scatter radiation exposure, individual shielding shall be provided as follows:
8.9.5.1. The operator, other staff and
ancillary personnel, and each other individual required for the medical
procedure or who cannot be removed from the room, shall be protected from
direct scatter radiation:
8.9.5.1.1. By a
protective apron or whole-body protective barrier of not less than 0.25
millimeter lead equivalent; and/or
8.9.5.1.2. Shall be so positioned that the
nearest portion of the body is at least a distance of 2 meters from the:
8.9.5.1.2.1. Tube head; and
8.9.5.1.2.2. Patient;
8.9.5.1.3. Except that protective positioning
shall be as determined by the operator of a portable handheld x-ray device, as
described in Section
8.15.
8.9.6. When a patient or image receptor must
be provided with auxiliary support during a radiation exposure:
8.9.6.1. Mechanical holding devices shall be
used when the technique permits.
8.9.6.2. The human holder shall be instructed
in personal radiation safety and protected as required by Section
8.9.5;
8.9.6.3. No individual shall be used
routinely to hold image receptor or patients;
8.9.6.4. In those cases where the patient
must hold the image receptor, except during dental examinations per Section
8.14, any portion of the body other than
the area of clinical interest struck by the useful beam shall be protected by
not less than 0.5 millimeter lead equivalent material; and
8.9.6.5. Each facility shall have protective
aprons and gloves available in sufficient numbers to provide protection for all
personnel who are involved with x-ray operations and who are otherwise not
shielded.
8.9.6.6. A record shall
be made of the examination and shall include the name of the human holder; date
of the examination, number of exposures and technique factors utilized for the
exposure(s).
8.9.7. Image
processing procedures and auxiliary equipment designed to minimize patient and
personnel exposure commensurate with the needed diagnostic information shall be
utilized.
8.9.7.1. The fastest imaging system
consistent with the diagnostic objective of the examinations shall be used.
Film cassettes without intensifying screens shall not be used for any
diagnostic radiological imaging, except:
8.9.7.1.1. For veterinary radiography;
or
8.9.7.1.2. For intraoral use in
dental radiography when standard film packets are used.
8.9.7.2. The radiation exposure to the
patient shall be the minimum exposure required to produce images of good
diagnostic quality.
8.9.7.3.
Facilities that use radiographic film shall establish and implement a quality
assurance program for x-ray film processing, whether processing is manual or
automatic.
8.9.7.4. Each
installation using a radiographic x-ray system and using analog image receptors
(e.g., radiographic film) shall have available suitable equipment for handling
and processing radiographic film in accordance with the following provisions:
8.9.7.4.1. Manual Processing of Films
8.9.7.4.1.1. The temperature of solutions in
the tanks shall be maintained within the range of 60 degrees F to 80 degrees F
(16 degrees C to 27 degrees C). Film shall be developed in accordance with the
time-temperature relationships recommended by the film manufacturer.
8.9.7.4.1.2. Devices shall be utilized which
will:
8.9.7.4.1.2.1. Indicate the actual
temperature of the developer; and
8.9.7.4.1.2.2. Give an audible or visible
signal indicating the termination of a preset processing time.
8.9.7.4.1.3. Processing tanks shall
be constructed of mechanically rigid, corrosion resistant material.
8.9.7.4.2. Automatic Processors
and Other Closed Processing Systems
8.9.7.4.2.1. Films shall be processed in
accordance with the time/temperature relationships recommended by the film
manufacturer; and
8.9.7.4.2.2.
Processing deviations from the requirements of Section
8.9.7.4.2.1 shall be documented by
the registrant in such manner that the requirements are shown to be met or
exceeded (e.g., extended processing and special rapid
chemistry).
8.9.7.5. If grids are used between the
patient and the image receptor to decrease scatter to the film and improve
contrast, the grid shall:
8.9.7.5.1. Be
positioned properly (i.e., tube side facing the proper direction) and grid
centered to the central ray.
8.9.7.5.2. If of the focused type, be of the
proper focal distance for the source-image receptor distance (SID) being
used.
8.9.7.6. Other
Requirements
8.9.7.6.1. Film shall be stored
in a cool, dry place and shall be protected from exposure to stray radiation.
Film in open packages shall be stored in a light-tight container.
8.9.7.6.2. Film cassettes and intensifying
screens shall be inspected periodically and shall be cleaned and replaced as
necessary to ensure radiographs of good diagnostic quality.
8.9.7.6.3. Outdated x-ray film shall not be
used for diagnostic radiographs, unless the film has been stored in accordance
with the manufacturer's recommendations and a sample of the film passes a
sensitometric test for normal ranges of base plus fog and speed.
8.9.7.6.4. Film developing solutions shall be
prepared in accordance with the directions given by the manufacturer and shall
be maintained in strength by replenishment or renewal so that full development
is accomplished within the time specified by the manufacturer.
8.10. Quality
Assurance (QA) Program
8.10.1. All registrants
of diagnostic x-ray imaging equipment shall establish and maintain a quality
assurance program consisting of quality control assessments addressing at least
the following items:
8.10.1.1. Written
standard operating procedures on radiation protection that are reviewed
annually and updated as needed by management;
8.10.1.2. Employee review and written
acknowledgement of standard operating procedures and policies on radiation
protection; and
8.10.1.3. Record
retention in accordance with applicable Vermont statutes and regulations, but
in no case less than 3 years.
8.10.2. The quality assurance program shall
be in written form and available for review by the Department.
8.10.3. To avoid unnecessary or duplicative
radiation exposures, each human use and veterinary facility shall have an
active image processing quality control and quality assurance (QA) program that
follows manufacturers' recommendations and/or the standards of one of the
following organizations:
8.10.3.1. The
American College of Radiology; or
8.10.3.2. American Association of Physicists
in Medicine; or
8.10.3.3. National
Council on Radiation Protection and Measurements (NCRP); or
8.10.3.4. The Joint Commission
8.10.4. Each registrant that uses
a hard copy imaging system with transmission viewing, whether with or without
liquid chemistry, shall document that quality control and quality assurance
have been performed according to recommendations of the manufacturer or a
Qualified Medical Physicist, including:
8.10.4.1. Periodic printing of a
sensitometric strip or pattern;
8.10.4.2. Documentation of low, medium, and
high-density calibration and that any calibration which failed to meet a
manufacturer's recommendation was corrected before the image printer was used
to print another image; and
8.10.4.3. Annual review of all quality
control tests.
8.10.5.
Each registrant that uses an automatic film processor shall adopt an acceptable
sensitometric quality control program.
8.10.5.1. Film processors used to develop
radiographs shall be adjusted and maintained to meet the technical development
specifications for the radiography film in use.
8.10.5.2. For all x-ray imaging systems, a
continuous and documented sensitometric quality control program, including
quality control tests for speed, contrast, and fog, shall be performed
according to recommendations of the manufacturer and/or a Qualified Medical
Physicist.
8.10.6. Each
registrant that uses a manual film process shall:
8.10.6.1. Follow applicable manufacturer's
development time and temperature recommendations, which shall be available for
review;
8.10.6.2. Measure and log
development temperature each day of use; and
8.10.6.3. Document in writing the change of
developer chemicals at least every month.
8.10.7. The registrant shall control darkroom
lighting such that:
8.10.7.1. Exposure of a
film to the darkroom safelight for one minute does not increase the optical
density of that film by more than 0.1 optical density units when the test film
has a latent image sufficient to produce a density between 1.0 and 2.0 optical
density units prior to safe light exposure.
8.10.7.2. If used, daylight film handling
boxes preclude fogging of the film.
8.10.7.3. The base plus fog of an unexposed
film does not exceed 0.25 optical density units when developed by the routine
procedure used by the facility.
8.10.8. All film storage, including pass
boxes, if provided, shall be so constructed as to exclude light from the
darkroom when cassettes are placed in or removed from the boxes, and shall
incorporate adequate shielding from stray radiation to prevent exposure of
undeveloped film.
8.10.9. The
registrant shall ensure that each monitor used for primary image interpretation
is evaluated according to recommendations of the manufacturer, a Qualified
Medical Physicist and/or one of the following nationally recognized
organizations:
8.10.9.1. The American
Association of Physicists in Medicine; or
8.10.9.2. The American College of Radiology;
or
8.10.9.3. NCRP; or
8.10.9.4. The Joint Commission
8.10.10. The registrant shall
ensure that computed and digital radiography cassettes and cassette readers
used for primary image interpretation are evaluated periodically according to
recommendations of the manufacturer and/or a Qualified Medical Physicist and/or
a nationally recognized organization listed in 8.10.9.
8.11. Reports and Notifications of Radiation
Medical Events
8.11.1. Other than events that
result from intervention by a patient or human research subject, a registrant
shall report any event in which the administration of ionizing radiation from a
diagnostic radiation machine meets one or more of the following criteria for a
radiation medical event:
8.11.1.1. A patient
or human research subject receives an unintended skin dose greater than 2 Gy
(200 rads) to the same area in a single procedure.
8.11.1.2. A patient or human research subject
receives in a single procedure greater than:
8.11.1.2.1. Five times the intended dose
index, and 500 mGy (50 rads) to any organ; or
8.11.1.2.2. Five times the intended dose
index, and 50 mSv (5 rem) total effective dose.
8.11.1.3. Wrong patient or wrong site for the
entire procedure when the resultant dose:
8.11.1.3.1. Exceeds 500 mGy (50 rads) to any
organ; or
8.11.1.3.2. Total
effective dose is greater than or equal to 50 mSv (5 rem).
8.11.1.4. Equipment failure, personnel error,
accident, mishap or other unusual occurrence with the administration of
ionizing radiation that exceeds 50 mGy (5 rads) total effective dose.
8.11.2. Any wrong patient or wrong
site imaged, regardless of dose received, shall be reported, documented and
addressed internally within the facility, and the records maintained for
inspection.
8.11.3. The registrant
shall notify the Department by telephone or email no later than the next
business day after discovery of the radiation medical event.
8.11.4. The registrant shall submit a written
report to the Department within 15 business days after discovery of the
radiation medical event. The written report shall include:
8.11.4.1. The registrant's name;
8.11.4.2. Date of event and date
discovered;
8.11.4.3. The total
estimated dose received;
8.11.4.4.
The imaging procedure(s) performed;
8.11.4.5. The type of equipment in use (e.g.,
CT, fluoroscopy, radiographic, other);
8.11.4.6. The manufacturer and model of the
unit used;
8.11.4.7. Why the event
occurred;
8.11.4.8. How the event
was discovered;
8.11.4.9. The
effect, if any, on the individuals(s) who is the subject of the radiation
medical event;
8.11.4.10. Actions,
if any, that have been taken, or are planned, to prevent recurrence;
8.11.4.11. Certification that the registrant
notified the individual (or the individual's responsible relative or guardian),
and if not, why not; and
8.11.4.12.
If there was notification, what information was provided to the
individual.
8.11.5.
Records of Radiation Medical Events
8.11.5.1.
A registrant shall retain a record of a radiation medical event reported in
accordance with Section
8.11 as part of the patient's permanent
medical record.
8.12. Special Requirements for General
Purpose Radiographic Equipment
8.12.1.
Administrative Controls
8.12.1.1. In addition
to the provisions of Sections
8.2 through
8.11, the requirements of this Section
apply to all x-ray imaging equipment and associated facilities other than:
8.12.1.1.1. Fluoroscopy (in Section
8.13);
8.12.1.1.2. Dental (in Section
8.14);
8.12.1.1.3. Handheld Diagnostic (in Section
8.15)
8.12.1.1.4. Veterinary (in Section
8.16);
8.12.1.1.5. Computed tomography (in Section
8.17);
8.12.1.1.6. Mammography (in Section
8.18)
8.12.1.1.7. Bone densitometry (in Section
8.19)
8.12.2. For each general purpose stationary,
mobile, and/or portable x-ray imaging system subject to the requirements of
this Section, the useful beam shall be limited to the area of clinical
interest.
8.12.3. Radiation
Exposure Control Devices
8.12.3.1. X-ray
Control
8.12.3.1.1. An x-ray control shall be
incorporated into each x-ray system such that an exposure can be terminated by
the operator at any time except for:
8.12.3.1.1.1. Exposure of one-half second or
less, or
8.12.3.1.1.2. During
serial radiography when a means shall be provided to permit completion of any
single exposure of the series in process.
8.12.3.1.2. Except for a bone densitometry
system, each x-ray control shall be located in such a way as to meet the
following requirements:
8.12.3.1.2.1. For
stationary x-ray systems, the x-ray control shall be permanently mounted in a
separated area behind a whole body protective barrier, as described in
shielding plan, where the operator is required to remain during the entire
exposure. If no barrier is described in the shielding plan, then not less than
0.25 millimeter lead equivalent shall be used.
8.12.3.1.2.2. Mobile and portable x-ray
systems shall be required to have an exposure switch so arranged that the
operator can stand at least 2 meters (more than 6 feet) from the patient, the
x-ray tube, and the useful beam, or behind a whole body protective barrier (of
not less than 0.25 millimeter lead equivalent) where the operator is required
to remain during the entire exposure.
8.12.3.1.3. The settings to be used during an
exposure shall be indicated before the exposure begins.
8.12.3.1.3.1. When automatic exposure
controls are used, the exposure settings that are set prior to the exposure
shall be indicated.
8.12.3.1.3.2.
On equipment having fixed exposure settings, permanent markings visible from
the operator's position are acceptable.
8.12.3.2. Accuracy for a Diagnostic X-ray
System with Any Certified Component
8.12.3.2.1. If manufacturer recommendations
regarding exposure settings are available, those shall be followed.
8.12.3.2.2. If manufacturer recommendations
are not available, the following criteria shall be used:
8.12.3.2.2.1. The kVp shall not deviate from
indicated values by more than 7%.
8.12.3.2.2.2. The timer accuracy shall not
deviate from indicated values by more than:
8.12.3.2.2.2.1. Ten percent for an indicated
time of greater than 20 milliseconds; or
8.12.3.2.2.2.2. Fifty percent for an
indicated time of 20 milliseconds or less, or 1 pulse, whichever is
greater.
8.12.3.2.3. Criteria that is more protective
of patient health than the criteria identified in section
8.12.3.2 may be
utilized.
8.12.4. For each general-purpose x-ray
imaging system, the registrant shall ensure that manufacturer maintenance
recommendations are followed.
8.12.5. For each general-use diagnostic
radiographic x-ray system, the registrant shall ensure that written quality
control and quality assurance procedures are available and in use, including
for facility operations and emergencies.
8.12.5.1. The quality control and quality
assurance procedures shall be consistent with Section
8.10 and shall follow:
8.12.5.1.1. Recommendations of the
manufacturer;
8.12.5.1.2.
Recommendations of a Qualified Medical Physicist; and/or
8.12.5.1.3. Standards of one of the following
nationally recognized organizations:
8.12.5.1.3.1. The American College of
Radiology; or
8.12.5.1.3.2. The
American Association of Physicists in Medicine; or
8.12.5.1.3.3. NCRP; or
8.12.5.1.3.4. The Joint Commission
8.12.5.2. Routine
periodic quality control shall be comparable to the recommendations of the
manufacturer and Qualified Medical Physicist, or the following:
8.12.5.2.1. Cassette maintenance (for
example, erasure and/or screen cleaning);
8.12.5.2.2. Images inspected for evidence of
clinically relevant artifacts (for example, dust and non-uniformities) with
appropriate corrective action (for example, cleaning of screens) taken as
needed and documented;
8.12.5.2.3.
Analysis of repeated and/or rejected images;
8.12.5.2.4. Investigation of errors outside a
control range;
8.12.5.2.5.
Measurements using phantoms, if required; and
8.12.5.2.6. Measurements of scattered
radiation at the operator's position, if required.
8.12.5.3. Quality assurance shall be
comparable to the following:
8.12.5.3.1. All
quality control tests shall be reviewed at least every 24 months;
8.12.5.3.2. Imaging systems shall be tested
in accordance with standards and protocols published by the American College of
Radiology, the American Association of Physicists in Medicine, NCRP, and/or the
Joint Commission.
8.12.5.3.3. The
frequency of quality control testing and corrective actions taken as a result
are followed and documented.
8.13. Special Requirements for Fluoroscopy
Systems
8.13.1. In addition to the provisions
of Section
8.6 and Section
8.10, the requirements of this Section
apply to all fluoroscopic x-ray imaging equipment and facilities.
8.13.2. Only image-intensified or
direct-digital-receptor fluoroscopic equipment shall be used.
8.13.3. Overhead fluoroscopy shall not be
used as a positioning tool for general purpose radiographic
examinations.
8.13.4. Each
registrant that uses fluoroscopic x-ray systems shall maintain for each
examination a record of:
8.13.4.1. The
cumulative fluoroscopic exposure time used, and the number of images recorded
from the fluoroscopic image receptor; or
8.13.4.2. The air kerma and/or dose-area
product.
8.13.4.3. This record
shall include patient identification, type and date of examination, the
fluoroscopic system used, and operator's name. The record shall be maintained
for 5 years.
8.13.5.
Control of Scattered Radiation
8.13.5.1.
Fluoroscopic table designs, when combined with procedures utilized, shall be
such that no unprotected part of any staff or ancillary individual's body shall
be exposed to unattenuated scattered radiation which originates from under the
table. The attenuation required shall be not less than 0.25-millimeter lead
equivalent.
8.13.5.2. Equipment
configuration, when combined with procedures, shall be such that no portion of
any staff or ancillary individual's body, except the extremities, shall be
exposed to the unattenuated scattered radiation emanating from above the
tabletop unless that individual:
8.13.5.2.1.
Is at least 120 centimeters from the center of the useful beam, or
8.13.5.2.2. The radiation has passed through
not less than 0.25-millimeter lead equivalent material (e.g., drapes,
Bucky-slot cover-sliding or folding panel, or self-supporting curtains) in
addition to any lead equivalency provided by the protective apron referred to
in Section
8.8.1.2.
8.13.5.3. The Department may grant exemptions
to the requirements of Section
8.13.5.2 where a sterile field will not
permit the use of the normal protective barriers. Where the use of pre-fitted
sterilized covers for the barriers is practical, the Department shall not
permit such exception.
8.13.6. Patient Dose Evaluation
8.13.6.1. Each registrant performing
fluoroscopically-guided interventional procedures shall develop written
policies and procedures to:
8.13.6.1.1.
Identify those procedures which have a potential to result in patient doses
exceeding the threshold for injury;
8.13.6.1.2. Reduce the probability of such
exposures; and
8.13.6.1.3. Ensure
that appropriate action occurs for patients receiving doses that warrant
follow-up.
8.13.6.2. The
registrant shall have patient dose monitoring procedures in place and shall
document (in the patient's medical record) an estimate of the absorbed dose to
the skin, or sufficient information to enable this calculation. When the
fluoroscopy unit is equipped with an air kerma dose readout, the recording of
this value shall suffice as a patient dose record.
8.13.6.3. The registrant shall conduct
patient dose evaluation for any procedure that has a reasonable probability of
resulting in a deterministic injury (i.e. a cumulative absorbed dose to the
skin equal to or greater than 2 Gy (200 rads)). This evaluation shall be noted
in the patient's medical record and reviewed by the Radiation Safety Officer,
who shall consult with other Qualified Experts as needed.
8.13.7. Radiation Therapy Simulation Systems
8.13.7.1. Radiation therapy simulation
systems shall be exempt from the requirements of
21 CFR
1020.32(a), provided such
systems are intended only for remote control operation.
8.13.7.2. Radiation therapy simulation
systems shall be exempt from the requirements of
21 CFR
1020.32(b) and
21 CFR
1020.32(d) when used for
therapy simulation purposes.
8.13.7.3. As an alternative to the
requirements of 21 CFR
1020.32(g), radiation
therapy simulation systems may be provided with a means to indicate the total
cumulative exposure time during which x-rays were produced, and which is
capable of being reset between x-ray examinations.
8.13.8. All quality control tests shall be
reviewed by a Qualified Medical Physicist at least annually (in extenuating
circumstances, 14 months is permissible).
8.14. Special Requirements for Dental X-ray
Imaging Systems
8.14.1. In addition to the
provisions of Sections
8.2 through
8.11, the requirements of this Section
apply to equipment and associated facilities used for dental x-ray
imaging.
8.14.2. For each dental
x-ray imaging system, manufacturer maintenance specifications shall be
followed.
8.14.3. Each dental x-ray
imaging system shall meet the following equipment design and configuration
requirements.
8.14.3.1. Cephalometric and
volumetric dental x-ray systems shall meet the equipment design and
configuration requirements of Sections
8.5 and
8.12.2.
8.14.3.2. Intraoral and panoramic dental
x-ray systems shall meet the following requirements:
8.14.3.2.1. kVp Limitations. Dental x-ray
machines with a nominal fixed kVp of less than 60 kVp shall not be used to make
diagnostic dental radiographs of humans.
8.14.3.2.2. Each x-ray imaging system
designed for use with an intraoral image receptor shall be provided with means
to SSD to not less than 20 centimeters. Open-ended cones are required to reduce
scattered radiation.
8.14.3.2.3.
Each x-ray imaging system designed for use with an intraoral image receptor
shall be provided with means to limit the beam such that the x-ray field, at
the minimum SSD, shall be containable in a circle having a diameter of no more
than 7 centimeters.
8.14.3.2.4. As
provided in Section
5.3.5, neither the shielding design
described in Section
8.5 nor the dimensional drawing,
calculation, or survey described in Section
8.5.3 are required for intraoral or
panoramic dental equipment.
8.14.3.2.4.1.
Conventional building materials in partitions, floors, and ceilings may provide
adequate radiation shielding for dental installations. When a conventional
building structure does not provide adequate shielding, the shielding shall be
increased by providing greater thickness of building materials or by adding
lead, concrete, steel, or other suitable materials to the walls, floor, and
ceiling of an existing room.
8.14.3.2.5. Mechanical support of the tube
head and pointer cone shall maintain the exposure position without drift or
vibration of sufficient magnitude to cause the need for manually restraining
the tube or retaking the x-ray.
8.14.4. Each dental x-ray imaging system
shall meet the following radiation exposure operational control requirements.
8.14.4.1. Cephalometric and volumetric beam
dental x-ray systems shall meet the radiation exposure control requirements of
Section 8.12.3.
8.14.4.2. Intraoral and panoramic dental
x-ray systems shall meet the following radiation exposure control requirements
instead of the requirements of Section
8.12.3:
8.14.4.2.1. Timer Reproducibility
8.14.4.2.1.1. With a timer setting of 0.5
seconds or less, the average exposure period (Tavg) shall be greater than or
equal to 5 times the maximum exposure period (Tmax) minus the minimum exposure
period (Tmin) when 4 timer tests are performed: Tavg >= 5(Tmax -
Tmin).
8.14.4.2.2. X-ray
Control for Intraoral or Panoramic Dental X-ray Systems
8.14.4.2.2.1. A control shall be incorporated
into each x-ray imaging system such that an exposure can be terminated by the
operator at any time, except for exposures of 0.5 second or less.
8.14.4.2.2.2. Each control shall be located
as follows:
8.14.4.2.2.2.1. For stationary
x-ray systems, and mobile or non-handheld portable systems, the x-ray control
shall be permanently mounted in a separated area behind a whole body protective
barrier (of not less than 0.25 millimeter lead equivalent) where the operator
is required to remain during the entire exposure, or the exposure control shall
be such that the operator can stand at least 2 meters (more than 6 feet) from
the patient, the x-ray tube, and the useful beam.
8.14.4.2.3. Exposure
Reproducibility
8.14.4.2.3.1. The estimated
coefficient of variation of radiation exposure shall be no greater than 0.05,
for any specific combination of selected exposure settings.
8.14.4.2.4. Linearity shall be in
accordance with 21 CFR
1020.31(c)(3).
8.14.4.2.5. Accuracy
8.14.4.2.5.1. Deviation of exposure settings
from indicated values shall not exceed the limits specified for that system by
its manufacturer.
8.14.4.2.5.2. If
manufacturer specifications are not available, accuracy of all exposure factors
shall be within 10% of the selected factor(s).
8.14.4.2.6. Beam Quality
8.14.4.2.6.1. All dental x-ray systems shall
have a minimum half-value layer not less than 1.5 millimeters aluminum
equivalent.
8.14.4.2.6.2. Systems
operating above 70 kVp are subject to the filtration requirements of
21 CFR
1020.30(m)(1).
8.14.4.2.7. Patient and image receptor
holding devices shall be used when the techniques permit.
8.14.4.2.8. The tube housing and the position
indicator device (PID) shall not be handheld during an exposure, except as
provided in Section
8.15 for portable handheld x-ray
equipment.
8.14.4.2.9. The x-ray
system shall be operated in such a manner that the area of the useful beam at
the patient's skin is minimized.
8.14.4.2.10. Dental fluoroscopy shall not be
used.
8.14.4.2.11. Image receptors
of speeds slower than ANSI Speed Group E/F shall not be used for intraoral
radiography (i.e., D-speed film shall not be used).
8.14.4.2.12. Screen-film systems of speeds
slower than ANSI 400 shall not be used for panoramic or cephalometric imaging.
Rare-earth systems shall be used.
8.14.4.3. The x-ray control shall provide:
8.14.4.3.1. Visual indication observable at
the operator's protected position whenever x-rays are produced; and
8.14.4.3.2. A signal audible to the operator
shall indicate that the exposure has terminated.
8.14.4.4. A thyroid shield shall be used for
patients to reduce patient exposure to scattered radiation (except for a case
in which shielding would interfere with the diagnostic procedure).
8.14.4.5. Absent structural protection
against scatter radiation, during radiation machine operation at least a
2-meter distance (more than 6 feet) shall be maintained from any bystander
location and between patient operating chairs.
8.14.5. For each dental x-ray imaging system,
written quality control and quality assurance procedures shall include:
8.14.5.1. For processing of intraoral and
panoramic films, performance of the following:
8.14.5.1.1. Follow applicable manufacturer's
time and temperature specifications, which shall be available for
review;
8.14.5.1.2. Measure and log
temperature each day of use; and
8.14.5.1.3. Document in a written log the
change of developer chemicals at least every month.
8.14.5.2. For volumetric dental systems,
conduct periodic calibrations and annual quality control tests according to the
manufacturer's specifications, including any additional or more frequent
testing necessary at the recommendation of a Qualified Medical
Physicist.
8.14.5.3. Annual review
of all quality control tests.
8.15. Special Requirements for Handheld
Dental Diagnostic X-Ray Imaging Systems
8.15.1. In addition to the provisions of
Section 8.2 through
8.11, the requirements of this Section
apply to equipment and associated facilities used for handheld dental
diagnostic x-ray imaging.
8.15.2.
For each handheld x-ray imaging system, manufacturer maintenance specifications
shall be followed.
8.15.3. The
registrant shall follow all applicable requirements set forth in Section
8.14, as well as all manufacturer
requirements.
8.15.4. The following
requirements are applicable to intraoral dental radiographic units designed to
be operated as a handheld unit for human or veterinary use:
8.15.4.1. Intraoral dental radiographic units
designed to be operated as a handheld unit for human or veterinary use must be
approved in writing by the Department prior to being used in Vermont.
8.15.4.2. The machine shall be used only for
dental diagnostic imaging or identification of a decedent.
8.15.4.3. Operators of handheld intraoral
dental radiographic units shall be specifically trained to operate such
equipment, and the registrant shall maintain proof of training for all
operators.
8.15.4.4. The registrant
shall provide a copy of their operating, safety and security procedures to
operators to prevent unauthorized or improper use.
8.15.4.5. When operating a handheld intraoral
dental radiographic unit, operators shall be protected from direct scatter
radiation by protective material of not less than 0.25 millimeter lead
equivalent to protect the operator's torso, hands, face, and gonads.
8.15.4.5.1. A backscatter shield attached to
the unit is required and shall be positioned as close to the patient as
possible and the operator shall take care to remain in a protective
position.
8.15.4.5.2. The
protective shielding on the unit shall not be removed or modified.
8.15.4.6. A separate exposure
switch is not required for portable handheld x-ray equipment that has the
control on the device.
8.15.4.7. A
handheld intraoral dental radiographic unit shall be held with minimal motion
during a patient examination such that the image produced is diagnostically
useable. A tube stand may be utilized to immobilize a handheld intraoral dental
radiographic unit during patient examination.
8.15.4.8. The operator shall ensure there are
no bystanders within a radius of 6 feet from the patient being examined with a
handheld intraoral radiographic unit.
8.15.4.8.1. The device shall not be operated
if a person other than the patient, operator, and others directly involved in
providing care, are present in the room in which the x-ray device will be
operated. As provided in 8.8.1.1, if such person(s) are required to be present
for the purpose of aiding in the procedure, such person(s) shall be provided
with and required to wear full body shielding of no less than 0.25 millimeter
lead equivalent and shall be required to remain out of the direct
beam.
8.15.4.9. Handheld
intraoral dental radiographic units shall not be used for patient examinations
in hallways and waiting rooms.
8.15.4.10. The registrant shall comply with
any facility-specific requirements established by the Department.
8.15.4.11. For battery-powered units, visual
means shall be provided on the control panel to indicate whether the battery is
in a state of charge adequate for proper operation.
8.15.4.12. Handheld devices shall only be
used with dental film speeds E or faster or with digital imaging.
8.15.4.13. A handheld intraoral dental
radiographic unit shall not be left unattended without locking the unit, room,
or building in some manner which prevents use of the unit by unauthorized
persons.
8.15.4.14. Missing or
stolen handheld devices shall be reported to the Department immediately. A
written report of the loss including all available details shall be submitted
to the Department within 24 hours.
8.15.4.15. The device shall have an inherent
safety mechanism to prevent accidental exposures when the device is "on" but
not active between imaging procedures. The device shall be maintained in lock
down (safety engaged) mode at all times between patient exposures so that the
device cannot be accidentally operated.
8.16. Special Requirements for Veterinary
Medicine Imaging Systems
8.16.1. In addition
to the provisions of Section
8.2 through
8.11, and as appropriate also 8.13 and
8.17, the requirements in this Section apply to equipment and associated
facilities used for veterinary x-ray imaging.
8.16.2. Each veterinary x-ray imaging system
shall follow manufacturer maintenance specifications.
8.16.3. Each veterinary medicine installation
shall meet the following equipment design and configuration requirements.
8.16.3.1. Equipment
8.16.3.1.1. The protective tube housing shall
be equivalent to the requirements of
10 CFR
1020.30(k).
8.16.3.1.2. Diaphragms or cones shall be
provided for collimating the useful beam to the area of clinical interest and
shall provide the same degree of protection as is required of the
housing.
8.16.3.1.3. The local
filtration permanently in the useful beam shall meet the requirement of
10 CFR
1020.30(m)(1).
8.16.3.2. A method shall be provided for
visually defining the perimeter of the x-ray field.
8.16.3.2.1. The total misalignment of the
edges of the visually defined field with the respective edges of the x-ray
field along either the length or width of the visually defined field shall not
exceed 2% of the distance from the source to the center of the visually defined
field when the surface upon which it appears is perpendicular to the axis of
the x-ray beam.
8.16.3.3.
Structural Shielding
8.16.3.3.1. All wall,
ceiling, and floor areas shall be equivalent to or provided with applicable
protective barriers to ensure compliance with Sections
7.2 and
7.4 through
7.6.
8.16.3.3.2. A veterinary installation shall
meet the requirements of Section
8.5 in order to minimize radiation exposure
to personnel and individual members of the public.
8.16.3.3.3. Veterinary facilities are exempt
from the requirements of the Department's Shielding Design Requirements
guidance document as long as the requirements of Section
8.16.3.3 are met.
8.16.3.4. Linearity shall be in accordance
with 21 CFR
1020.31(c)(3).
8.16.3.5. Accuracy
8.16.3.5.1. Deviation of exposure settings
from indicated values shall not exceed the limits specified for that system by
its manufacturer.
8.16.3.5.2. If
manufacturer specifications are not available, the following criteria shall be
used:
8.16.3.5.2.1. The kVp shall not deviate
from indicated values by more than 10%.
8.16.3.5.2.2. The timer accuracy shall not
deviate from indicated values by more than:
8.16.3.5.2.2.1. Ten percent for an indicated
time of greater than 20 milliseconds; or
8.16.3.5.2.2.2. Fifty percent for an
indicated time of 20 milliseconds or less, or 1 pulse, whichever is
greater.
8.16.3.6. Exposure Reproducibility
8.16.3.6.1. The coefficient of variation of
exposure shall not exceed 0.05 when all exposure settings are held
constant.
8.16.3.7. A
dead-man type of exposure switch or equivalent remote device shall enable the
operator to stand out of the useful beam.
8.16.4. Each veterinary medicine installation
shall have the following operating and radiation exposure control procedures.
8.16.4.1. Whenever possible, the operator
shall be positioned during radiographic exposures so that the nearest portion
of the body is at least 2 meters (more than 6 feet) from both the tube head and
the nearest edge of the image receptor.
8.16.4.1.1. For mobile or portable
radiographic equipment, the radiographic exposure control switch shall be
located on the machine where adequate personnel protection is provided to
attenuate the direct and scatter radiation, or the length of the switch cord
shall be such that the operator shall be able to stand at least 2 meters (more
than 6 feet) from the patient, the x-ray tube, and out of the useful beam. A
coil type extension switch cord capable of providing more than 2 meters of
distance protection is recommended.
8.16.4.2. No individual, other than the
operator, shall be in the x-ray room while exposures are being made, unless
such individual's assistance is required, and the person is adequately
protected by shielding and/or distance.
8.16.4.2.1. All other staff and ancillary
personnel required for the procedure shall be protected from direct scatter
radiation by protective aprons or whole-body protective barriers of not less
than 0.25-millimeter lead equivalent.
8.16.4.3. When an animal must be held in
position during radiography, mechanical supporting or restraining devices
should be used.
8.16.4.3.1. Each individual
other than the animal being examined shall be positioned such that no part of
the body will be struck by the useful beam.
8.16.4.3.2. If the animal must be held by an
individual, that individual shall be protected with appropriate shielding
devices, such as protective gloves and apron, and the individual shall be so
positioned so that no part of the individual's body will be struck by the
useful beam.
8.16.4.3.3. The
exposure of any individual used for this purpose shall be maintained below the
limits specified in Sections
7.2,
7.4, and 7.5.
8.16.4.4. Use of portable handheld x-ray
equipment shall be consistent with Section
8.15.
8.16.4.5. Mobile or portable diagnostic x-ray
equipment used regularly (e.g. greater than one week) in one location shall be
considered a fixed installation and shall meet the requirements of Section
8.16.3.
8.16.5. Each veterinary x-ray imaging system
shall have written quality control and quality assurance procedures that
include:
8.16.5.1. For processing of
veterinary films, performance of the following:
8.16.5.1.1. Follow applicable manufacturer's
time and temperature specifications, which shall be available for
review;
8.16.5.1.2. Measure and log
temperature each day of use; and
8.16.5.1.3. Document in a written log the
change of developer chemicals at least every month.
8.16.5.2. Annual review of all quality
control tests.
8.17. Special Requirements for Computed
Tomography (CT)
8.17.1. In addition to the
provisions of Section
8.2 through
8.11, the requirements of Section
8.17 apply to equipment and associated
facilities used for CT.
8.17.2. For
a CT machine used only for veterinary applications, or a cone-beam CT used only
for dental applications, the registrant may request from the Department
exemption from any requirement of this Section that is not applicable to the
practices of the registrant.
8.17.3. Each CT facility shall meet the
following equipment design and configuration requirements:
8.17.3.1. Termination of Exposure
8.17.3.1.1. 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.
8.17.3.1.1.1. 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.
8.17.3.1.2. A visible signal shall indicate
when the x-ray exposure has been terminated through the means required by
Section 8.17.3.1.1.
8.17.3.1.3. 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 one-half second
duration.
8.17.3.2.
Patient Communication
8.17.3.2.1. Provision
shall be made for two-way aural communication between the patient and the
operator at the control panel.
8.17.3.2.2. 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 control panel.
8.17.3.2.3. Patient scanning shall be allowed
only when a viewing system is available and in use.
8.17.4. Each CT facility
shall have the following operating procedures and radiation exposure controls.
8.17.4.1. Console Performance
8.17.4.1.1. The CT x-ray system shall not be
operated except by an individual who has been specifically trained in its
operation.
8.17.4.1.2. Information
shall be readily available regarding the operation of the system.
8.17.4.1.3. Information regarding calibration
of the system shall be readily available, including:
8.17.4.1.3.1. Dates of the latest calibration
and routine quality checks (QCs) and the location within the facility where the
results of those tests may be obtained;
8.17.4.1.3.2. Instructions on the use of the
CT performance phantom(s) including a schedule of routine QCs appropriate for
the system, allowable variations for the indicated parameters, and the results
of at least the most recent routine QCs conducted on the system;
8.17.4.1.3.3. When operators must select
exposure settings, a current protocol shall be available at the control panel
that specifies for each routine examination the CT conditions of operation and
the typical number of scans per examination, including guidance for
age-appropriate scanning.
8.17.4.2. Extraneous Radiation
8.17.4.2.1. When data are not being collected
for image production, the radiation adjacent to the tube port shall not exceed
that permitted by 21 CFR
1020.30(k).
8.17.4.3. Additional Requirements Applicable
to CT x-ray Systems Containing a Gantry Manufactured After September 2, 1992.
8.17.4.3.1. The total error in the indicated
location of the tomographic plane or reference plane shall not exceed 5
millimeters.
8.17.4.3.2. If the
x-ray production period is less than one-half second, the indication of x-ray
production shall be actuated for at least one-half 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 useful beam is
possible.
8.17.4.3.3. The deviation
of indicated scan increment versus actual increment shall not exceed plus or
minus 1 millimeter with any mass from 0 to 100 kg resting on the support
device.
8.17.4.3.3.1. The patient support
device shall be incremented from a typical starting position to the maximum
incremented distance, the manufacturer's specified distance, or 30 centimeters,
whichever is less, and then returned to the starting position.
8.17.4.3.3.2. Measurement of actual versus
indicated scan increment may be taken anywhere along this travel.
8.17.4.3.3.3. When table increment is not the
primary means of slice position location, the Qualified Medical Physicist may
provide alternative measurement procedures to determine the accuracy of slice
position, which shall be documented.
8.17.4.3.4. Premature termination of the
x-ray exposure by the operator shall necessitate resetting of the CT conditions
of operation prior to the initiation of another scan.
8.17.5. Each CT facility shall
conduct required surveys, evaluations, calibrations, and routine QCs.
8.17.5.1. Surveys and Evaluations
8.17.5.1.1. A radiation survey, or inspection
during construction, shall be made by, or under the direct supervision of, a
Qualified Medical Physicist, to verify and document compliance with Section
7.6 for:
8.17.5.1.1.1. Any change in the facility or
equipment that might cause a significant increase in radiation hazard;
or
8.17.5.1.1.2. Any initial or new
location for a CT imaging system that is designed to be transported from place
to place.
8.17.5.1.2. CT
x-ray systems that have undergone an x-ray tube change within 14 months of the
last annual evaluation do not require a complete calibration at the time of the
x-ray tube change, provided that:
8.17.5.1.2.1. The CT x-ray system operation
after the tube change meets the criteria established by the Qualified Medical
Physicist or the manufacturer of the x-ray tube.
8.17.5.1.2.2. Each CT system shall receive a
survey by a Qualified Medical Physicist at least within 14 months of the
previous survey.
8.17.5.2. Radiation Dosimetry
8.17.5.2.1. The radiation output of the CT
x-ray system shall be measured by, or under the personal supervision of, a
Qualified Medical Physicist:
8.17.5.2.1.1. At
intervals (not exceeding 14 months) specified by a Qualified Medical
Physicist;
8.17.5.2.1.2. In
accordance with protocols published by a relevant nationally recognized
organizations (e.g. AAPM Report 96), unless the Qualified Medical Physicist
determines that a particular recommendation of such report is not warranted for
the clinical tasks for which the equipment will be used;
8.17.5.2.1.3. With a calibrated dosimetry
system:
8.17.5.2.1.3.1. That shall have been
calibrated by the National Institute for Standards and Technology (NIST) or by
an American Association of Physicists in Medicine (AAPM) Accredited Dosimetry
Calibration Laboratory (ADCL); and
8.17.5.2.1.3.2. Calibrated within the
preceding 2 years.
8.17.5.2.2. CT dosimetry shall be evaluated
by a Qualified Medical Physicist in accordance with protocols published by one
of the following nationally recognized organizations:
8.17.5.2.2.1. The American Association of
Physicists in Medicine; or
8.17.5.2.2.2. The American College of
Radiology; or
8.17.5.2.2.3. NCRP;
or
8.17.5.2.2.4. The Joint
Commission
8.17.5.2.3.
Records of measurements performed shall be maintained for a period of 3 years
for inspection by the Department.
8.17.5.3. Routine QCs
8.17.5.3.1. The routine Quality Control (QC)
procedures shall be in writing and shall have been approved by a Qualified
Medical Physicist.
8.17.5.3.2. The
routine QC procedures shall incorporate the use of a commensurate CT
performance phantom.
8.17.5.3.3.
All routine QCs shall be performed at time intervals and under system
conditions specified by a Qualified Medical Physicist.
8.17.5.3.4. Images shall be retained, at
least until a new QC test is performed, as follows:
8.17.5.3.4.1. Photographic copies of the
images obtained from the image recording device; or
8.17.5.3.4.2. Images stored in digital form
on a storage medium compatible with the CT x-ray system.
8.17.5.3.5. Written or electronic records of
the routine QCs performed shall be maintained for inspection by the
Department.
8.17.6. Each CT system shall have written
quality control and quality assurance procedures, including:
8.17.6.1. If a calibration required by
Section 8.17.5.2 or a
routine QC required by Section
8.17.5.3 identifies that a system
operating parameter is outside a specified or recommended tolerance or range:
8.17.6.1.1. The CT x-ray system shall not be
used on a patient except as permitted by documented instructions of the
Qualified Medical Physicist (or by the radiologist in instances of artifacts);
and
8.17.6.1.2. Correction or
modification shall be made within 30 days of the date of the test identifying
the problem.
8.17.6.2.
The CT system shall meet the recommendations of the manufacturer or Qualified
Medical Physicist and/or appropriate nationally recognized organization, or
equivalent approved by the Department, for:
8.17.6.2.1. Alignment light
accuracy;
8.17.6.2.2. Slice
thickness;
8.17.6.2.3. Image
quality; and
8.17.6.2.4. CT number
accuracy.
8.17.6.3. All
quality control tests shall be reviewed by a Qualified Medical Physicist at
least annually (in extenuating circumstances, 14 months is
permissible).
8.18. Special Requirements for Mammography
8.18.1. In addition to the provisions of
Sections 8.2 through
8.11, the requirements of this Section
apply to equipment and associated facilities used for mammography.
8.18.2. Each facility performing mammography
shall:
8.18.2.1. Meet the requirements of
21 CFR
900;
8.18.2.2. Have a valid certificate issued by
the U.S. Department of Health and Human Services (HHS) pursuant to the
Mammography Quality Standards Reauthorization Act of 1998,
Public Law
105-248 , and
21 CFR
900;
8.18.2.3. Ensure that
21 CFR
900 quality control and quality assurance
standards for maintaining viewing conditions and interpretation of an image are
met.
8.18.3. The
regulatory requirements of Section
8.0 shall also apply as appropriate to
radiography of the breast performed:
8.18.3.1.
During invasive interventions for localization or biopsy (for example,
stereotactic biopsy procedures); or
8.18.3.2. With an investigational device as
part of a scientific study conducted in accordance with FDA investigational
device exemption regulations; or
8.18.3.3. During any other procedure for
radiography of the breast that the Department determines and
designates.
8.19. Special Requirements for Bone
Densitometry
8.19.1. In addition to the
provisions of Sections
8.2 through
8.11, the requirements of this Section
apply to equipment and associated facilities used for bone
densitometry.
8.19.2. Bone
densitometry systems shall be:
8.19.2.1.
Certified by the manufacturer pursuant to the Medical Device Act and Subchapter
C-Electronic Product Radiation Control (EPRC) of Chapter V of the Federal Food,
Drug and Cosmetic Act; and
8.19.2.2. Maintained and operated in
accordance with the manufacturer's specification and
recommendations.
8.19.3.
Bone densitometry systems with stepless collimators shall be provided with
means to both size and align the x-ray field such that the x-ray field at the
plane of the image receptor does not extend beyond 2% of the SID.
8.19.4. During the operation of any bone
densitometry system:
8.19.4.1. The operator,
ancillary personnel, and members of the general public shall be positioned at
least one meter from the patient and bone densitometry system during the
examination.
8.19.4.2. The operator
shall advise the patient that the bone densitometry examination is a type of
x-ray procedure.
8.19.5.
The registrant shall keep maintenance records for bone densitometry systems as
prescribed by Section
8.19.2.2. These records shall be
maintained for inspection by the Department for 3 years from the date the
maintenance action was completed.
8.19.6. Bone densitometry on human patients
shall be conducted only:
8.19.6.1. Under a
prescription of a licensed practitioner of the healing arts; or
8.19.6.2. Under a screening program approved
by the Department.
8.19.6.2.1. Any person
proposing to conduct a bone densitometry screening program shall submit the
information outlined in Section
5.6 and include the name and address of the
licensed practitioner of the healing arts who will interpret the screening
results.
9.0 Particle Accelerators and Therapeutic
Radiation Machines in the Healing Arts.
9.1.
Purpose and Scope
9.1.1. This Section
establishes requirements, for which the registrant is responsible, for use of
therapeutic radiation machines. The provisions of this Section are in addition
to, and not in substitution for, other applicable provisions of this
Rule.
9.1.2. The registrant shall
be responsible for directing the operation of the therapeutic radiation
machines which have been registered with the Department. The registrant shall
ensure that the requirements of this Section are met in the operation of the
therapeutic radiation machine(s).
9.2. Administrative Controls
9.2.1. Each therapeutic radiation machine
shall be registered with the Department.
9.2.2. The applicant shall have appointed a
Radiation Safety Officer and include this information on the registration
form.
9.2.3. A therapeutic
radiation machine that does not meet the provisions of this Rule shall not be
used for irradiation of patients.
9.2.4. For a therapeutic radiation machine
used only for veterinary applications, the registrant may request from the
Department exemption from any requirement of this Section that is not
applicable to the practices of veterinary medicine.
9.3. Training for Qualified Medical Physicist
The registrant for any therapeutic radiation machine subject to the provisions of this Section shall require the Qualified Medical Physicist to be registered with the Department, under the provisions of Sections 5.7 and 5.14, as a provider of radiation services in the area of calibration and compliance surveys of external beam radiation therapy units.
9.4.
Qualifications of Operators
9.4.1.
Individuals who will be operating a therapeutic radiation machine for medical
use on humans shall be licensed as a Radiation Therapist.
9.4.2. Each individual who will be operating
a therapeutic radiation machine for veterinary use shall meet qualification
criteria specified by the supervising radiation therapy veterinarian.
9.4.3. The names and training of all
personnel currently operating a therapeutic radiation machine shall be kept on
file at the facility. Information on former operators shall be retained for a
period of at least 2 years beyond the last date they were authorized to operate
a therapeutic radiation machine at that facility.
9.5. Written Safety Procedures
9.5.1. Written (which can be in a digital
format) safety procedures and rules shall be developed by a Qualified Medical
Physicist that is certified in radiation therapy physics, and shall be
available in the control area of a therapeutic radiation machine, including any
restrictions required for the safe operation of the particular therapeutic
radiation machine.
9.5.2. The
operator shall be able to demonstrate to the Department familiarity with these
rules.
9.6. Exposure
Prohibited
9.6.1. Individuals shall not be
exposed to the useful beam except for medical therapy purposes and unless such
exposure has been ordered in writing by a Radiation Oncologist or radiation
therapy physician.
9.6.2. The
deliberate exposure of an individual for training, demonstration or other
non-healing-arts purposes is prohibited.
9.7. Quality Management Program
9.7.1. All individuals associated with the
operation of a therapeutic radiation machine shall be instructed in, and shall
comply with, the provisions of the registrant's quality management
program.
9.7.2. Each registrant
subject to Sections
9.18,
9.19, or 9.21 shall develop, implement and
maintain a written quality management program to provide high confidence that
radiation will be administered by the operator as directed. The quality
management program shall address, at a minimum, the following specific
objectives:
9.7.2.1. Written Directive
9.7.2.1.1. A written directive must be dated
and signed by a Radiation Oncologist or radiation therapy physician prior to
the administration of radiation;
9.7.2.1.2. Notwithstanding Section
9.7.2.1.1, if, because of the
patient's condition, a delay in order to provide a written revision to an
existing written directive would jeopardize the patient's health, an oral
revision to an existing written directive shall be acceptable, provided that
the oral revision is documented immediately in writing in the patient's record
and a revised written directive is signed by a Radiation Oncologist or
radiation therapy physician within 48 hours of the oral revision.
9.7.2.1.3. The written directive shall
contain the patient's name, the type and energy of the beam, the total dose,
dose per fraction, treatment site, and number of fractions.
9.7.2.1.4. A written revision to an existing
written directive may be made provided that the revision is dated and signed by
a Radiation Oncologist or radiation therapy physician prior to the
administration of the therapeutic radiation machine dose, or the next
fractional dose.
9.7.2.1.5. The
registrant shall retain a copy of each written directive, in an auditable form,
for 3 years after the date of each administration.
9.7.2.2. The registrant shall develop,
implement, and maintain written procedures to provide high confidence that:
9.7.2.2.1. Prior to the administration of
each course of radiation treatments, the patient's identity is verified, by
more than one method, as the individual named in the written
directive;
9.7.2.2.2. Therapeutic
radiation machine final plans of treatment and related calculations are
developed under the direct supervision of a therapeutic Qualified Medical
Physicist, and in accordance with the respective written directives by:
9.7.2.2.2.1. Checking both manual and
computer-generated dose calculations to verify they are correct and in
accordance with the written directive; and
9.7.2.2.2.2. Verifying that any manual and
computer-generated calculations are correctly transferred into the consoles of
therapeutic radiation machines;
9.7.2.2.3. Each administration is in
accordance with the written directive; and
9.7.2.2.4. Any unintended deviation from the
written directive is identified and evaluated, and appropriate action is
taken.
9.7.2.2.5. A registrant
shall retain a copy of the procedures required by Section
9.7.2.2 for the duration of the
registration.
9.7.3. Each registrant using radiation
therapy equipment shall have a quality management program that includes the
following:
9.7.3.1. The specific staff, staff
duties and responsibilities, equipment, and procedures,
9.7.3.2. An evaluation of a representative
sample of patient administrations and a review of all recordable events, and
all misadministrations, if any, to verify compliance with all aspects of the
quality management program;
9.7.3.3. Reviews conducted at intervals not
to exceed 1 year;
9.7.3.4. An
evaluation of each review to determine the effectiveness of the quality
management program and, if necessary, to make modifications to meet the
requirements of these rules; and
9.7.3.5. Records of each review, including
the evaluations and findings of the review, which shall be retained for 3
years.
9.7.4. The
registrant shall submit a written copy of this quality management program to
the Department.
9.7.5. The
registrant may make modifications to the quality management program to increase
the program's efficiency provided the program's effectiveness is not
decreased.
9.8. Shielding
and Safety Design Requirements
9.8.1. Primary
and Secondary Barriers
9.8.1.1. Each
therapeutic radiation machine subject to Section
9.18 or Section
9.19 shall be provided with such primary
and/or secondary barriers as are necessary to ensure compliance with Sections
7.2 and
7.6.
9.8.2. Facility Design Information
9.8.2.1. Facility design information for all
new installations of a therapeutic radiation machine or installations of a
therapeutic radiation machine of higher energy into a room not previously
approved for that energy shall be submitted for Department approval prior to
actual installation of the therapeutic radiation machine. The minimum facility
design information that must be submitted is:
9.8.2.1.1. For any therapeutic radiation
machine, the following basic facility information:
9.8.2.1.1.1. Facility name;
9.8.2.1.1.2. Facility telephone
number;
9.8.2.1.1.3. Name of the
individual responsible for preparation of the shielding plan;
9.8.2.1.1.4. Name and telephone number of the
facility supervisor;
9.8.2.1.1.5.
The facility street address;
9.8.2.1.1.6. The facility room number for the
therapeutic radiation machine;
9.8.2.1.1.7. Indication if this is a new
structure or a modification to existing structure(s);
9.8.2.1.1.8. The primary barriers for all
wall, floor, and ceiling areas struck by the useful beam;
9.8.2.1.1.9. All secondary barriers provided
in all wall, floor, and ceiling areas not having primary barriers;
9.8.2.1.1.10. If commercial software is used
to generate shielding requirements, the software name, version, and date of
revision;
9.8.2.1.1.11. If the
software used to generate shielding requirements is not in the open literature,
quality control sample calculations to verify the result obtained with the
software;
9.8.2.1.1.12. The
structural composition and thickness or lead equivalent of all walls, doors,
partitions, floor, and ceiling of the room(s) concerned;
9.8.2.1.1.13. The type of occupancy of all
adjacent areas inclusive of space above and below the room(s) concerned, and
any exterior wall(s), with distance to the closest area(s) where it is likely
that individuals may be present; and
9.8.2.1.1.14. At least one example
calculation which shows the methodology used to determine the amount of
shielding required for each primary and secondary/leakage barrier, restricted
and unrestricted areas, entry door(s), and shielding material in the
facility.
9.8.2.1.2. In
addition to the requirements listed in Section
9.8.2.1.1, therapeutic radiation
machine facilities which produce only photons with a maximum energy less than
or equal to 150 kV shall submit shielding plans which contain, as a minimum,
the following additional information:
9.8.2.1.2.1. Equipment specifications,
including the manufacturer and model number of the therapeutic radiation
machine, as well as the maximum technique factors;
9.8.2.1.2.2. Maximum design workload for the
facility to include:
9.8.2.1.2.2.1. Total
weekly radiation output expressed in gray (rad) or air kerma at 1
meter;
9.8.2.1.2.2.2. Total beam-on
time per day or week;
9.8.2.1.2.2.3. The average treatment time per
patient; and
9.8.2.1.2.2.4. The
anticipated number of patients to be treated per day or week; and
9.8.2.1.2.3. A facility
blueprint/drawing indicating:
9.8.2.1.2.3.1.
Scale;
9.8.2.1.2.3.2. Direction of
North;
9.8.2.1.2.3.3. Normal
location of the therapeutic radiation machine's radiation port(s);
9.8.2.1.2.3.4. The port's travel and traverse
limits;
9.8.2.1.2.3.5. General
direction(s) of the useful beam;
9.8.2.1.2.3.6. Locations of any windows and
doors;
9.8.2.1.2.3.7. The location
of the therapeutic radiation machine control panel;
9.8.2.1.2.3.8. The location of the operator's
booth if the control panel is located inside the therapeutic radiation machine
treatment room; and
9.8.2.1.2.3.9.
The operator's station at the control panel has a protective barrier sufficient
to ensure compliance with Section
7.2.
9.8.2.1.3. In addition to the requirements
listed in Section
9.8.2.1.1, therapeutic radiation
machine facilities that produce photons with a maximum energy in excess of 150
kV or electrons shall submit shielding plans which contain, as a minimum, the
following additional information:
9.8.2.1.3.1.
Equipment specifications to include:
9.8.2.1.3.1.1. The manufacturer;
9.8.2.1.3.1.2. The model number of the
therapeutic radiation machine;
9.8.2.1.3.1.3. The energy(s) and type(s) of
radiation produced; and
9.8.2.1.3.1.4. The target to isocenter
distance;
9.8.2.1.3.2.
Maximum design workload for the facility including:
9.8.2.1.3.2.1. Total weekly radiation output
expressed in gray or rad at 1 meter;
9.8.2.1.3.2.2. Total beam-on time per day or
week;
9.8.2.1.3.2.3. The average
treatment time per patient; and
9.8.2.1.3.2.4. The anticipated number of
patients to be treated per day or week;
9.8.2.1.3.3. Facility blueprint or drawing
indicating:
9.8.2.1.3.3.1. The floor plan and
elevation views each indicating relative orientation of the therapeutic
radiation machine;
9.8.2.1.3.3.2.
Type(s), thickness, and minimum density of shielding material(s);
9.8.2.1.3.3.3. Direction of North;
and
9.8.2.1.3.3.4. The locations
and size of all beam penetrations through each ceiling, wall, floor, details of
the door(s) and maze shielding barrier; and
9.8.2.1.3.4. A description of all assumptions
that were in the shielding calculations including, but not limited to:
9.8.2.1.3.4.1. Design energy;
9.8.2.1.3.4.2. Workload;
9.8.2.1.3.4.3. Presence of integral beam-stop
in unit;
9.8.2.1.3.4.4. Occupancy
and use(s) of adjacent areas;
9.8.2.1.3.4.5. Fraction of time that useful
beam will intercept each permanent barrier for all walls, floor and ceiling;
and
9.8.2.1.3.4.6. Potential
radiation exposure in both restricted and unrestricted areas.
9.8.2.1.4. In addition
to the requirements listed in Section
9.8.2.1.3, therapeutic radiation
machine facilities which are capable of operating above 10 MV shall submit
shielding plans which contain, as minimum, the following additional
information:
9.8.2.1.4.1. The structural
composition, thickness, minimum density, and location of all neutron shielding
material;
9.8.2.1.4.2. Description
of all assumptions that were used in neutron shielding calculations including,
but not limited to;
9.8.2.1.4.2.1. Neutron
spectra as a function of energy;
9.8.2.1.4.2.2. Neutron fluence rate;
and
9.8.2.1.4.2.3. Absorbed dose
and dose equivalent for neutrons in both restricted and unrestricted
areas;
9.8.2.1.4.3. At
least one example calculation which shows the methodology used to determine the
amount of neutron shielding required for each restricted and unrestricted
areas, entry door(s), maze and the neutron shielding material utilized in the
facility; and
9.8.2.1.4.4. The
method(s) and instrumentation which will be used to verify the adequacy of all
neutron shielding installed in the facility.
9.9. Protection Surveys
9.9.1. The registrant shall ensure that
radiation protection surveys of all new facilities, and existing facilities not
previously surveyed are performed with an operable radiation measurement survey
instrument calibrated in accordance with Section
9.11. The radiation protection survey shall
be performed by, or under the direction of, a Qualified Medical Physicist and
shall verify that, with the therapeutic radiation machine in a "BEAM-ON"
condition, with the largest clinically available treatment field and with a
scattering phantom in the useful beam of radiation:
9.9.1.1. Radiation levels in restricted areas
are not likely to cause personnel exposures in excess of the limits specified
in Section
7.2; and
9.9.1.2. Radiation levels in unrestricted
areas do not exceed the limits specified in Section
7.6.
9.9.2. In addition to the requirements of
Section 9.9.1, a radiation
protection survey shall also be performed prior to any subsequent medical use
and:
9.9.2.1. After making any change in the
treatment room shielding;
9.9.2.2.
After making any change in the location of the therapeutic radiation machine
within the treatment room;
9.9.2.3.
After relocating the therapeutic radiation machine; or
9.9.2.4. Before using the therapeutic
radiation machine in a manner that could result in increased radiation levels
in areas outside the external beam radiation therapy treatment room.
9.9.3. The survey record shall
indicate all instances where the radiation levels exceed the requirements of
Sections 7.2 or
7.6, as applicable. The survey record shall
include:
9.9.3.1. The date of the
measurement(s);
9.9.3.2. The reason
the survey is required;
9.9.3.3.
The name of the manufacturer of the therapeutic radiation machine;
9.9.3.4. The model number and serial number
of the therapeutic radiation machine;
9.9.3.5. The instrument(s), with calibration
details, used to measure the radiation levels;
9.9.3.6. A map of the areas surrounding the
treatment room that were surveyed;
9.9.3.7. The measured dose rate at several
points in each area expressed in microsievert (or millirem) per hour;
9.9.3.8. The calculated maximum radiation
dose for each restricted and unrestricted area to demonstrate compliance with
7.6; and
9.9.3.9. The signature of
the individual performing or exercising personal supervision of the
survey.
9.9.4. If the
results of the surveys required by Section
9.9.1 and Section
9.9.2 indicate any radiation levels in
excess of the respective limit specified in Section
9.9.1, the registrant shall lock the
control in the "OFF" position and not use the unit:
9.9.4.1. Except as may be necessary to
repair, replace, or test the therapeutic radiation machine, the therapeutic
radiation machine shielding, or the treatment room shielding; or
9.9.4.2. Until the registrant has received a
specific exemption from the Department.
9.10. Modification of Radiation Therapy Unit
or Room Before Beginning a Treatment Program
9.10.1. If the survey required by Section
9.9 indicates that an individual in an
unrestricted area may be exposed to levels of radiation greater than those
permitted by Section
7.6, before beginning the treatment program
the registrant shall:
9.10.1.1. Either equip
the unit with beam direction interlocks or add additional radiation shielding
to ensure compliance with Section
7.6;
9.10.1.2. Perform the survey required by
Section 9.9 again; and
9.10.1.3. Include in the report required by
Section 9.13 the results of the
initial survey, a description of the modification made to comply with Section
9.10.1 and the results of the second
survey.
9.11.
Calibration of Survey Instruments
9.11.1.
Calibration Required
9.11.1.1. The registrant
shall ensure that the survey instruments used to show compliance with Section
9.0 have been calibrated before first use,
at intervals not to exceed 12 months and following repair.
9.11.2. Calibration Protocols
9.11.2.1. To satisfy the requirements of
Section 9.11.1.1, the
registrant shall:
9.11.2.1.1. Calibrate all
required scale readings up to 10 mSv (1000 mrem) per hour with an appropriate
radiation source that is traceable to the National Institute of Standards and
Technology (NIST).
9.11.2.1.2.
Calibrate at least 2 points on each scale to be calibrated. These points should
be at approximately 1/3 and 2/3 of full-scale.
9.11.2.2. Consider a point as calibrated if
the indicated dose rate differs from the calculated dose rate by not more than
10%.
9.11.2.3. Consider a point as
calibrated if the indicated dose rate differs from the calculated dose rate by
not more than 20% if a correction factor or graph is conspicuously attached to
the instrument.
9.11.3.
Record Retention
9.11.3.1. The registrant
shall retain a record of each calibration required in Section
9.11.1.1 for 3 years. The record shall
include:
9.11.3.1.1. A description of the
calibration procedure; and
9.11.3.1.2. A description of the source used
and the certified dose rates from the source, and the rates indicated by the
instrument being calibrated, the correction factors deduced from the
calibration data, the signature of the individual who performed the
calibration, and the date of calibration.
9.11.4. Use of Calibration Services
9.11.4.1. The registrant may obtain the
services of individuals licensed by the Department, the U.S. Nuclear Regulatory
Commission or another Agreement State to perform calibrations of survey
instruments. Records of calibrations which contain information required by
Section 9.11.3 shall be
maintained by the registrant.
9.12. Dosimetry Equipment
9.12.1. The registrant shall have a
calibrated dosimetry system available for use.
9.12.1.1. The system shall have been
calibrated by the National Institute for Standards and Technology (NIST) or by
an American Association of Physicists in Medicine (AAPM) Accredited Dosimetry
Calibration Laboratory (ADCL).
9.12.1.2. The calibration shall have been
performed within the previous 24 months and after any servicing that may have
affected system calibration.
9.12.1.3. For beams with energies greater
than 1 MV (1 MeV), the dosimetry system shall have been calibrated for
Cobalt-60.
9.12.1.4. For beams with
energies equal to or less than 1 MV (1 MeV), the dosimetry system shall have
been calibrated at an energy (energy range) appropriate for the radiation being
measured.
9.12.2. The
registrant shall have available for use a dosimetry system for quality
assurance check measurements.
9.12.2.1. To
meet this requirement, the system may be compared with a system that has been
calibrated in accordance with Section
9.12.1.
9.12.2.2. This comparison shall have been
performed within the previous 12 months and after each servicing that may have
affected system calibration.
9.12.2.3. The quality assurance check system
may be the same system used to meet the requirement in Section
9.12.1.
9.12.3. The registrant shall maintain a
record of each dosimetry system calibration, intercomparison, and comparison
for the duration of the registration. For each calibration, intercomparison, or
comparison, the record shall include:
9.12.3.1. The date;
9.12.3.2. The model numbers and serial
numbers of the instruments that were calibrated, intercompared, or compared as
required by Sections
9.12.1 and
9.12.2;
9.12.3.3. The correction factors that were
determined;
9.12.3.4. The names of
the individuals who performed the calibration, intercomparison, or comparison;
and
9.12.3.5. Evidence that:
9.12.3.5.1. Calibration was performed by the
Accredited Dosimetry Calibration Laboratory (ADCL); or
9.12.3.5.2. The intercomparison was performed
by, or under the direct supervision of, a Qualified Medical
Physicist.
9.13. Reports of External Beam Radiation
Therapy Surveys and Measurements The registrant for any therapeutic radiation
machine subject to Section
9.18 or
9.19 shall submit a copy of the records
required in Section
9.9 and Section
9.10 to the Department within 30 days
following completion of the action that initiated the record
requirement.
9.14. Reports of
Misadministrations
9.14.1. A registrant shall
report to the Department any event resulting from intervention by a patient in
which the administration of therapeutic radiation machine radiation results in,
or is likely to result in, unintended permanent functional damage to an organ
or a physiological system, as determined by a physician.
9.14.2. Except for an event resulting from
intervention by a patient, a registrant shall report to the Department any
event regarding the administration of a therapeutic radiation machine therapy
dose:
9.14.2.1. Involves the wrong patient,
wrong treatment modality, or wrong treatment site; or
9.14.2.2. The calculated weekly administered
dose differs from the weekly prescribed dose by more than 30% (An event is not
required to be reported as a misadministration if a dose deviation occurs due
to the omission of a scheduled patient treatment which resulted from equipment
failure, failure by the patient to be present for the treatment, or decision by
the prescribing radiation therapy physician to delay or pause treatment.);
or
9.14.2.3. The calculated total
administered dose differs from the total prescribed dose by more than 20% of
the total prescribed dose.
9.14.3. The registrant shall notify the
Department's Radiological Health Program by telephone or email within 24 hours
after discovery of the misadministration.
9.14.4. The registrant shall submit a written
report to the Department within 15 days after discovery of the
misadministration. The written report shall include:
9.14.4.1. The registrant's name;
9.14.4.2. The name of the prescribing
physician;
9.14.4.3. A brief
description of the event;
9.14.4.4.
Why the event occurred;
9.14.4.5.
The effect, if any, on the individual(s) who received the
misadministration;
9.14.4.6.
Actions, if any, that have been taken, or are planned, to prevent
recurrence;
9.14.4.7. Certification
that the registrant notified the individual (or the individual's responsible
relative or guardian), and if not, why not; and
9.14.4.8. If there was notification, what
information was provided to the individual.
9.14.5. The report shall not contain the
individual's name or any other information that could lead to the
identification of the individual.
9.15. Notifications of Misadministrations
9.15.1. The registrant shall provide
notification of an event of misadministration within 24 hours after its
discovery:
9.15.1.1. To the referring
physician;
9.15.1.2. To the
individual who is the subject of the misadministration, or their responsible
relative or guardian, unless the referring physician personally informs the
registrant:
9.15.1.2.1. That based on medical
judgment, telling the individual would be harmful; or
9.15.1.2.2. That he or she will inform the
individual directly.
9.15.2. The registrant is not required to
notify the individual without first consulting the referring
physician.
9.15.3. If the referring
physician or the affected individual cannot be reached within 24 hours, the
registrant shall notify the individual as soon as possible
thereafter.
9.15.4. The registrant
shall not delay any appropriate medical care for the individual, including any
necessary remedial care as a result of the misadministration, because of any
delay in notification.
9.15.5. The
registrant shall inform the individual who is the subject of the
misadministration, or appropriate responsible relative or guardian, that a copy
of the report was submitted to the Department;
9.15.6. Upon request by the individual who is
the subject of the misadministration, the registrant shall provide a written
description of both the event and the potential consequences as they may affect
them.
9.15.6.1. The registrant shall provide a
copy of the record shall be to the referring physician within 15 days after
discovery of the misadministration.
9.15.7. Aside from the notification
requirement, nothing in Section
9.15 affects any rights or duties of
registrants and physicians in relation to each other, to individuals affected
by the misadministration, or to that individual's responsible relatives or
guardians.
9.16. Record
Maintenance and Retention
9.16.1. The
registrant shall maintain the following information in a separate file or
package for each therapeutic radiation machine, for inspection by the
Department:
9.16.1.1. Reports of acceptance
testing, as described in Section
9.19.20;
9.16.1.2. Records of all surveys,
calibrations, and periodic quality assurance checks of the therapeutic
radiation machine required by this Rule, as well as the name(s) of person(s)
who performed such activities;
9.16.1.3. Records of maintenance and/or
modifications performed on the therapeutic radiation machine as well as the
name(s) of person(s) who performed such services; and
9.16.1.4. Signature of person authorizing the
return of therapeutic radiation machine to clinical use after service, repair,
or upgrade.
9.16.1.5. Records of
Misadministrations
9.16.1.5.1. A registrant
shall retain a record of misadministrations reported in accordance with Section
9.14.4.
The record shall contain the following:
9.16.1.5.1.1. The registrant's name and the
names of the individuals involved (including the prescribing physician, allied
health personnel, the individual who received the misadministration, and the
individual's referring physician, if applicable);
9.16.1.5.1.2. The medical record number, or
other identification number, if one has been assigned, of the individual who is
the subject of the misadministration;
9.16.1.5.1.3. A brief description of the
event; why it occurred; the effect, if any, on the individual;
9.16.1.5.1.4. The actions, if any, taken or
planned to prevent recurrence; and
9.16.1.5.1.5. Whether the registrant notified
the individual (or the individual's responsible relative or guardian) and, if
not, whether such failure to notify was based on guidance from the referring
physician.
9.16.2. All records required by this Section
shall be retained in an active file for a period of at least 3 years from the
date of completion.
9.17.
Follow-up Required for Recordable Event
9.17.1. The registrant shall evaluate and
respond, within 30 days after discovery of the recordable event, to each
recordable event by:
9.17.1.1. Assembling the
relevant facts including the cause;
9.17.1.2. Identifying what, if any,
corrective action is required to prevent recurrence; and
9.17.1.3. Retaining a record, in an auditable
form, for 3 years, of the relevant facts and what corrective action, if any,
was taken.
9.18. Therapeutic Radiation Machines of Less
than 500 kV
9.18.1. Leakage Radiation
9.18.1.1. When the x-ray tube is operated at
its maximum rated tube current for the maximum kV, the leakage air kerma rate
shall meet the following requirements:
9.18.1.1.1. 5-50 kV Systems. The leakage air
kerma rate measured at any position 5 centimeters from the tube housing
assembly shall not exceed 1 mGy (100 mrad) in any 1 hour.
9.18.1.1.2. For >50 and <500 kV
systems:
9.18.1.1.2.1. The leakage air kerma
rate measured at a distance of 1 meter from the target in any direction shall
not exceed 1 cGy (1 rad) in any 1 hour period;
9.18.1.1.2.2. This air kerma rate measurement
may be averaged over areas no larger than 100 square centimeters (100 cm2);
and
9.18.1.1.2.3. The air kerma
rate at a distance of 5 centimeters from the surface of the tube housing
assembly shall not exceed 30 cGy (30 rad) per hour.
9.18.1.1.3. For each therapeutic radiation
machine, the registrant shall determine, or obtain from the manufacturer, the
leakage radiation existing at the positions specified in Section
9.18.1.1.1 and Section
9.18.1.1.2.1 for the specified
operating conditions. Records on leakage radiation measurements shall be
maintained at the installation for inspection by the
Department.
9.18.2. Permanent Beam Limiting Devices
9.18.2.1. Permanent diaphragms or cones used
for limiting the useful beam shall provide at least the same degree of
attenuation as required for the tube housing assembly.
9.18.3. Adjustable or Removable Beam Limiting
Devices
9.18.3.1. All adjustable or removable
beam limiting devices, diaphragms, cones or blocks shall not transmit more than
5% of the useful beam for the most penetrating beam used.
9.18.3.2. When adjustable beam limiting
devices are used, the position and shape of the radiation field shall be
indicated by a light beam.
9.18.4. Filter System
9.18.4.1. The filter system shall be so
designed that:
9.18.4.1.1. Filters cannot be
accidentally displaced at any possible tube orientation;
9.18.4.1.2. For equipment installed after
August 1, 1978, an interlock system prevents irradiation if the proper filter
is not in place;
9.18.4.1.3. The
air kerma rate escaping from the filter slot shall not exceed 1 cGy (1 rad) per
hour at 1 meter under any operating conditions; and
9.18.4.1.4. Each filter shall be marked as to
its material of construction and its thickness.
9.18.5. Tube Immobilization
9.18.5.1. The x-ray tube shall be so mounted
that it cannot accidentally turn or slide with respect to the housing aperture;
and
9.18.5.2. The tube housing
assembly shall be capable of being immobilized for stationary portal
treatments.
9.18.6.
Source Marking
9.18.6.1. The tube housing
assembly shall be so marked that it is possible to determine the location of
the source to within 5 millimeters, and such marking shall be readily
accessible for use during calibration procedures.
9.18.7. Beam Block
9.18.7.1. Contact therapy tube housing
assemblies shall have a removable shield of material, equivalent in attenuation
to 0.5 millimeters of lead at 100 kV, which can be positioned over the entire
useful beam exit port during periods when the beam is not in use.
9.18.8. Timer
9.18.8.1. A suitable irradiation control
device shall be provided to terminate the irradiation after a pre-set time
interval.
9.18.8.2. A timer which
has a display shall be provided at the treatment control panel. The timer shall
have a pre-set time selector and an elapsed time or time remaining
indicator.
9.18.8.3. The timer
shall be a cumulative timer which activates with an indication of "BEAM-ON" 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.
9.18.8.4. The timer shall terminate
irradiation when a pre-selected time has elapsed, if any dose monitoring system
present has not previously terminated irradiation.
9.18.8.5. The timer shall permit accurate
pre-setting and determination of exposure times as short as 1 second.
9.18.8.6. The timer shall not permit an
exposure if set at zero.
9.18.8.7.
The timer shall not activate until the shutter is opened when irradiation is
controlled by a shutter mechanism unless calibration includes a timer error
correction to compensate for mechanical lag; and
9.18.8.8. Timer shall be accurate to within
1% of the selected value or 1 second, whichever is greater.
9.18.9. Control Panel Functions
9.18.9.1. The control panel, in addition to
the displays required by other provisions in Section
9.18, shall have:
9.18.9.1.1. An indication of whether
electrical power is available at the control panel and if activation of the
x-ray tube is possible;
9.18.9.1.2.
An indication of whether x-rays are being produced;
9.18.9.1.3. Means for indicating x-ray tube
potential and current;
9.18.9.1.4.
The means for terminating an exposure at any time;
9.18.9.1.5. A locking device which will
prevent unauthorized use of the therapeutic radiation machine; and
9.18.9.1.6. For therapeutic radiation
machines manufactured after August 1, 1978, a positive display of specific
filter(s) in the beam.
9.18.10. Multiple Tubes
9.18.10.1. When a control panel may energize
more than one x-ray tube:
9.18.10.1.1. It
shall be possible to activate only one x-ray tube at any time;
9.18.10.1.2. There shall be an indication at
the control panel identifying which x-ray tube is activated; and
9.18.10.1.3. There shall be an indication at
the tube housing assembly when that tube is energized.
9.18.11. Target-to-SkinDistance
(TSD)
There shall be a means of determining the central axis TSD to within 1 centimeter and of reproducing this measurement to within 2 millimeters thereafter.
9.18.12.
Shutters
9.18.12.1. Unless it is possible to
bring the x-ray output to the prescribed exposure parameters within 5 seconds
after the x-ray "ON" switch is energized, the beam shall be attenuated by a
shutter having a lead equivalency not less than that of the tube housing
assembly.
9.18.12.2. After the unit
is at operating parameters, the shutter shall be controlled by the operator
from the control panel.
9.18.12.3.
An indication of shutter position shall appear at the control panel.
9.18.13. Low Filtration X-ray
Tubes
9.18.13.1. Each therapeutic radiation
machine equipped with a beryllium or other low-filtration window shall:
9.18.13.1.1. Be clearly labeled as such on
the tube housing assembly; and
9.18.13.1.2. Be provided with a permanent
warning device on the control panel that is activated when there is no
additional filtration present, in order to indicate that the dose rate is very
high.
9.18.14.
Facility Design Requirements for Therapeutic Radiation Machines Capable of
Operating in the Range 50 kV to 500 kV
9.18.14.1. In addition to shielding adequate
to meet requirements of Section
9.8, the treatment room shall meet the
following design requirements:
9.18.14.1.1.
Aural Communication. Provision shall be made for continuous two-way aural
communication between the patient/human research subject and the operator at
the control panel.
9.18.14.1.2.
Viewing Systems. Provision shall be made to permit continuous observation of
the patient/human research subject during irradiation and the viewing system
shall be so located that the operator can observe the patient/human research
subject from the control panel. The therapeutic radiation machine shall not be
used for patient/human research subject irradiation unless at least one viewing
system is operational.
9.18.15. Additional Requirements
9.18.15.1. Treatment rooms which contain a
therapeutic radiation machine capable of operating above 150 kV shall meet the
following additional requirements:
9.18.15.1.1. All protective barriers shall be
fixed except for entrance doors or beam interceptors;
9.18.15.1.2. The control panel shall be
located outside the treatment room;
9.18.15.1.3. Interlocks shall be provided
such that all entrance doors, including doors to any interior booths, 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 control panel; and
9.18.15.1.4. When any door referred to in
Section 9.18.15.1.3 is
opened while the x-ray tube is activated, the air kerma rate at a distance of 1
meter from the source shall be reduced to less than 1 mGy (100 mrad) per
hour.
9.18.16.
Full Calibration Measurements
9.18.16.1. Full
calibration of a therapeutic radiation machine subject to Section
9.18 shall be performed by, or under the
direct supervision of, a Qualified Medical Physicist:
9.18.16.1.1. Before the first medical use
following installation or reinstallation of the therapeutic radiation machine;
and
9.18.16.1.2. At intervals not
exceeding 12 calendar months; and
9.18.16.1.3 Before medical use under the
following conditions:
9.18.16.1.3.1. Whenever
quality assurance check measurements indicate that the radiation output differs
by more than 5% from the value obtained at the last full calibration and the
difference cannot be reconciled; and
9.18.16.1.3.2. Following any component
replacement, major repair, or modification of components that could
significantly affect the characteristics of the radiation beam.
9.18.16.1.4 Notwithstanding the
requirements of Section
9.18.16.1.3:
9.18.16.1.4.1. Full calibration of
therapeutic radiation machines with multi-energy capabilities is required only
for those modes and/or energies that are not within their acceptable range;
and
9.18.16.1.4.2. If the repair,
replacement or modification does not affect all energies, full calibration
shall be performed on the affected energy that is in most frequent clinical use
at the facility. The remaining energies may be validated with quality assurance
check procedures against the criteria in Section
9.18.16.1.3.1.
9.18.16.2. To satisfy
the requirement of Section
9.18.16.1, full calibration shall
include all measurements recommended for annual calibration by "AAPM Protocol
for 40-300 kV X-ray Beam Dosimetry in Radiotherapy and Radiobiology": AAPM
Report No. 76, prepared by AAPM Radiation Therapy Committee Task Group
#61.
9.18.16.3. The registrant
shall maintain a record of each calibration for the duration of the
registration, to include:
9.18.16.3.1. The
date of the calibration;
9.18.16.3.2. The manufacturer's name, model
number, and serial number for both the therapeutic machine and the x-ray
tube;
9.18.16.3.3. The model
numbers and serial numbers of the instruments used to calibrate the therapeutic
radiation machine; and
9.18.16.3.4.
The signature of the Qualified Medical Physicist responsible for performing the
calibration.
9.18.17. Periodic Quality Assurance Checks
9.18.17.1. Periodic quality assurance checks
shall be performed on therapeutic radiation machines subject to Section
9.18, which are capable of operation at
greater than or equal to 50 kV.
9.18.17.2. To satisfy the requirement of
Section 9.18.17.1, quality
assurance checks shall meet the following requirements:
9.18.17.2.1. The registrant shall perform
quality assurance checks in accordance with written procedures established by
the Qualified Medical Physicist; and
9.18.17.2.2. The quality assurance check
procedures shall specify:
9.18.17.2.2.1. The
frequency at which tests or measurements are to be performed;
9.18.17.2.2.2. That the quality assurance
check be performed during the calibration specified in Section
9.18.16.1; and
9.18.17.2.2.3. The acceptable tolerance for
each parameter measured in the quality assurance check, when compared to the
value for that parameter determined in the calibration as specified by Section
9.18.16.1.
9.18.17.3. The cause for a parameter
exceeding a tolerance set by the Qualified Medical Physicist shall be
investigated and corrected before the system is used for patient/human research
subject irradiation.
9.18.17.4.
Whenever a quality assurance check indicates a significant change in the
operating characteristics of a system, as specified in the Qualified Medical
Physicist's quality assurance check procedures, those elements of a full
calibration shall be performed, as required in Section
9.18.16.1, that are necessary to
determine that all affected parameters are within acceptable limits. Other
quality assurance check procedures should be repeated, as necessary, to ensure
that all system parameters are within acceptable limits.
9.18.17.5. The registrant shall use the
dosimetry system described in Section
9.12.2 to make the quality assurance
check required in Section
9.18.17.2.
9.18.17.6. The registrant shall have the
Qualified Medical Physicist review and sign the results of each radiation
output quality assurance check within 30 days of the date that the check was
performed.
9.18.17.7. The
registrant shall ensure that safety quality assurance checks of therapeutic
radiation machines subject to Section
9.18 are performed at intervals not to
exceed 30 days.
9.18.17.8.
Notwithstanding the requirements of Section
9.18.17.6 and Section
9.18.17.7, the registrant shall ensure
that no therapeutic radiation machine is used to administer radiation to humans
unless the quality assurance checks required by those Sections have been
performed within the 30-day period immediately prior to said
administration.
9.18.17.9. To
satisfy the requirement of Section
9.18.17.7, safety quality assurance
checks shall ensure proper operation of:
9.18.17.9.1. Electrical interlocks at each
external beam radiation therapy room entrance;
9.18.17.9.2. Proper operation of the
"BEAM-ON" and termination switches;
9.18.17.9.3. Beam condition indicator lights
on the access door(s), control console, and in the radiation therapy
room;
9.18.17.9.4. Viewing
systems;
9.18.17.9.5. If
applicable, electrically operated treatment room doors from inside and outside
the treatment room.
9.18.17.10. The registrant shall maintain a
record of each quality assurance check required by Sections
9.18.17.1 and
9.18.17.7 for 3 years. The record
shall include:
9.18.17.10.1. The date of the
quality assurance check;
9.18.17.10.2. The manufacturer's name, model
number, and serial number for the therapeutic radiation machine;
9.18.17.10.3. The manufacturer's name, model
number, and serial number of the instrument(s) used to measure the radiation
output of the therapeutic radiation machine; and
9.18.17.10.4. The signature of the individual
who performed the periodic quality assurance check.
9.18.18. Operating
Procedures
9.18.18.1. The therapeutic
radiation machine shall not be used for irradiation of patients/human research
subjects unless the requirements of Sections
9.18.16 and
9.18.17 have been met.
9.18.18.2. Therapeutic radiation machines
shall not be left unattended unless secured pursuant to Section
9.18.9.1.5.
9.18.18.3. When a patient/human research
subject must be held in position for radiation therapy, mechanical supporting
or restraining devices shall be used.
9.18.18.4. The tube housing assembly shall
not be held by an individual during operation unless the assembly is designed
to require such holding and the peak tube potential of the system does not
exceed 50 kV. In such cases, the holder shall wear protective gloves and apron
of not less than 0.5 millimeters lead equivalency at 100 kV.
9.18.18.5. A copy of the current operating
and emergency procedures shall be maintained at the therapeutic radiation
machine control console.
9.18.18.6.
No individual other than the patient/human research subject shall be in the
treatment room during exposures from therapeutic radiation machines operating
above 150 kV.
9.18.18.7. At
energies less than or equal to 150 kV, any individual, other than the
patient/human research subject, in the treatment room shall be protected by a
barrier sufficient to meet the requirements of Section
7.2.
9.18.19. Possession of Survey Instrument(s)
9.18.19.1. Each facility location authorized
to use a therapeutic radiation machine in accordance with Section
9.18 shall possess appropriately calibrated
portable monitoring equipment.
9.18.19.1.1. As
a minimum, such equipment shall include a portable radiation measurement survey
instrument capable of measuring dose rates over the range 10 ?Sv (1 mrem) per
hour to 10 mSv (1000 mrem) per hour.
9.18.19.1.2. The survey instrument(s) shall
be operable and calibrated in accordance with Section
9.11.
9.19.
Therapeutic Radiation Machines - Photon Therapy Systems (500 kV and Above) and
Electron Therapy Systems (500 keV and Above)
9.19.1. Possession of Survey Instrument(s)
9.19.1.1. Each facility location authorized
to use a therapeutic radiation machine in accordance with this Section shall
possess appropriately calibrated portable monitoring equipment.
9.19.1.1.1. As a minimum, such equipment
shall include a portable radiation measurement survey instrument capable of
measuring dose rates over the range 10 ?Sv (1 mrem) per hour to 10 mSv (1000
mrem) per hour.
9.19.1.1.2. The
survey instrument(s) shall be operable and calibrated in accordance with
Section 9.11.
9.19.2. Leakage Radiation Outside the Maximum
Useful Beam in Photon and Electron Modes
9.19.2.1. The absorbed dose due to leakage
radiation (excluding neutrons) at any point outside the maximum-sized useful
beam, but within a circular plane of radius 2 meters which is perpendicular to
and centered on the central axis of the useful beam at the nominal treatment
distance (i.e. patient/human research subject plane), shall not exceed a
maximum of 0.2% and an average of 0.1% of the absorbed dose on the central axis
of the beam at the nominal treatment distance. Measurements shall be averaged
over an area not exceeding 100 cm2 at a minimum of 16 points uniformly
distributed in the plane.
9.19.2.2.
Except for the area defined in Section
9.19.2.1, the absorbed dose due to
leakage radiation (excluding neutrons) at 1 meter from the electron path
between the electron source and the target or electron window shall not exceed
0.5 percent of the absorbed dose on the central axis of the beam at the nominal
treatment distance. Measurements shall be averaged over an area not exceeding
100 cm2.
9.19.2.3. For equipment
manufactured after July 1, 1999, the neutron absorbed dose outside the useful
beam shall comply with International Electrotechnical Commission (IEC) Document
601-2-1 (most current revision); and
9.19.2.4. For each therapeutic radiation
machine, the registrant shall determine, or obtain from the manufacturer, the
leakage radiation existing at the positions specified in Section
9.19.2.1 through Section
9.19.2.3 for the specified operating
conditions. Records on leakage radiation measurements shall be maintained at
the installation for inspection by the Department.
9.19.3. Leakage Radiation Through Beam
Limiting Devices
9.19.3.1. Photon Radiation.
All adjustable or interchangeable beam limiting devices shall attenuate the
useful beam such that at the nominal treatment distance, the maximum absorbed
dose anywhere in the area shielded by the beam limiting device(s) shall not
exceed 2% of the maximum absorbed dose on the central axis of the useful beam
measured in a 100 cm2 radiation field, or maximum available field size if less
than 100 cm2.
9.19.3.2. Electron
Radiation. All adjustable or interchangeable electron applicators shall
attenuate the radiation, including but not limited to photon radiation
generated by electrons incident on the beam limiting device and electron
applicator and other parts of the radiation head, such that the absorbed dose
in a plane perpendicular to the central axis of the useful beam at the nominal
treatment distance shall not exceed:
9.19.3.2.1. A maximum of 2% and average of
0.5% of the absorbed dose on the central axis of the useful beam at the nominal
treatment distance. This limit shall apply beyond a line 7 centimeters outside
the periphery of the useful beam; and
9.19.3.2.2. A maximum of 10% of the absorbed
dose on the central axis of the useful beam at the nominal treatment distance.
This limit shall apply beyond a line 2 centimeters outside the periphery of the
useful beam.
9.19.3.3.
Measurement of Leakage Radiation
9.19.3.3.1.
Photon Radiation. Measurements of leakage radiation through the beam limiting
devices shall be:
9.19.3.3.1.1. Made with the
beam limiting devices closed;
9.19.3.3.1.2. Made with any residual aperture
blocked by at least 2 tenth value layers of suitable absorbing material;
9.19.3.3.1.3. In the case of
overlapping beam limiting devices, the leakage radiation through each set shall
be measured independently at the depth of maximum dose; and
9.19.3.3.1.4. Measurements shall be made
using a radiation detector of area not exceeding 10 cm2.
9.19.3.3.2. Electron Radiation. Measurements
of leakage radiation through the electron applicators shall be:
9.19.3.3.2.1. Made with the electron beam
directed into the air;
9.19.3.3.2.2. Made using a radiation detector
of area up to but not exceeding 1 cm2 suitably protected against radiation
which has been scattered from material beyond the radiation detector;
and
9.19.3.3.2.3. Made using 1
centimeter of water equivalent build up material.
9.19.3.3.3. Leakage radiation through beam
limiting devices shall be determined for photon radiation and for electron
radiation in radiation therapy machines which operate in both modes.
9.19.4. Filters/Wedges.
Filters and wedges used in therapeutic radiation machines shall meet the
following requirements:
9.19.4.1. Each wedge
filter which is removable from the system shall be clearly marked with an
identification number;
9.19.4.2.
Each removable wedge filter shall have the nominal wedge angle appear on the
wedge or wedge tray if permanently mounted to the tray;
9.19.4.3. If the wedge or wedge tray is
significantly damaged, the wedge transmission factor shall be
redetermined;
9.19.4.4. If the
absorbed dose rate information required by Section
9.19.9 relates exclusively to operation
with a field flattening filter or beam scattering foil in place, such foil or
filter shall be removable only by the use of tools.
9.19.4.5. For equipment manufactured after
January 1, 1985 which utilize a system of wedge filters, inter-changeable field
flattening filters, or interchangeable beam scattering foils:
9.19.4.5.1. 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 control panel, either manually or
automatically;
9.19.4.5.2. An
interlock system shall be provided to prevent irradiation if the filter
selected is not in the correct position;
9.19.4.5.3. A display shall be provided at
the treatment control panel showing the wedge filter(s), interchangeable field
flattening filter(s), and/or interchangeable beam scattering foil(s) in use;
and
9.19.4.5.4. An interlock shall
be provided to prevent irradiation if any filter and/or beam scattering foil
selection operation carried out in the treatment room does not agree with the
filter and/or beam scattering foil selection operation carried out at the
treatment control panel.
9.19.5. Stray Radiation in the Useful Beam
9.19.5.1. For equipment manufactured after
July 1, 1999, the registrant shall determine during acceptance testing, or
obtain from the manufacturer, data sufficient to ensure that x-ray stray
radiation in the useful electron beam, absorbed dose at the surface during
x-ray irradiation and stray neutron radiation in the useful x-ray beam are in
compliance with International Electrotechnical Commission (IEC) Document
601-2-1 (or the most current revision).
9.19.6. Beam Monitors
9.19.6.1. All therapeutic radiation machines
subject to Section
9.19 shall be provided with redundant beam
monitoring systems. The detectors for these systems shall be fixed in the
useful beam during treatment to indicate the dose monitor unit rate.
9.19.6.2. Equipment manufactured after
January 1, 1985 shall be provided with at least 2 independently powered
integrating dose meters. Alternatively, common elements may be used if the
production of radiation is terminated upon failure of any common
element.
9.19.6.3. Equipment
manufactured on or before January 1, 1985 shall be provided with at least 1
radiation detector. This detector shall be incorporated into a useful beam
monitoring system.
9.19.6.4. The
detector and the system into which that detector is incorporated shall meet the
following requirements:
9.19.6.4.1. Each
detector shall be removable only with tools and, if movable, shall be
interlocked to prevent incorrect positioning;
9.19.6.4.2. Each detector shall form part of
a beam monitoring system from whose readings in dose monitor units the absorbed
dose at a reference point can be calculated;
9.19.6.4.3. Each beam monitoring system shall
be capable of independently monitoring, interrupting, and terminating
irradiation;
9.19.6.4.4. For
equipment manufactured after January 1, 1985, the design of the beam monitoring
systems shall ensure that the:
9.19.6.4.4.1.
Malfunctioning of one system shall not affect the correct functioning of the
other system(s); and
9.19.6.4.4.2.
Failure of either system shall terminate irradiation or prevent the initiation
of radiation; and
9.19.6.4.5. Each beam monitoring system shall
have a legible display at the treatment control panel. For equipment
manufactured after January 1, 1985, each display shall:
9.19.6.4.5.1. Maintain a reading until
intentionally reset;
9.19.6.4.5.2.
Have only 1 scale and no electrical or mechanical scale multiplying
factors;
9.19.6.4.5.3. Utilize a
design such that increasing dose is displayed by increasing numbers;
and
9.19.6.4.5.4. In the event of
power failure, the beam monitoring information required in Section
9.19.6.4.5 displayed at the control
panel at the time of failure shall be retrievable in at least one system for a
20 minute period of time.
9.19.7. Beam Symmetry
9.19.7.1. A bent-beam linear accelerator with
beam flattening filter(s) subject to Section
9.19 shall be provided with auxiliary
device(s) to monitor beam symmetry.
9.19.7.2. The device(s) referenced in Section
9.19.7.1 shall be able to detect field
asymmetry greater than 10%.
9.19.7.3. The device(s) referenced in Section
9.19.7.1 shall be configured to
terminate irradiation if the specifications in Section
9.19.7.2 cannot be
maintained.
9.19.8.
Selection and Display of Dose Monitor Units
9.19.8.1. Irradiation shall not be possible
until a new selection of a number of dose monitor units has been made at the
treatment control panel.
9.19.8.2.
The pre-selected number of dose monitor units shall be displayed at the
treatment control panel until reset manually for the next
irradiation.
9.19.8.3. After
termination of irradiation, it shall be necessary to reset the dosimeter
display before subsequent treatment can be initiated.
9.19.8.4. For equipment manufactured after
January 1, 1985, after termination of irradiation, it shall be necessary for
the operator to reset the pre-selected dose monitor units before irradiation
can be initiated.
9.19.9.
Air Kerma Rate/Absorbed Dose Rate
9.19.9.1.
For equipment manufactured after January 1, 1985, a system shall be provided
from whose readings the air kerma rate or absorbed dose rate at a reference
point can be calculated. The radiation detectors specified in Section
9.19.6 may form part of this system. In
addition:
9.19.9.1.1. The dose monitor unit
rate shall be displayed at the treatment control panel;
9.19.9.1.2. If the equipment can deliver
under any conditions an air kerma rate or absorbed dose rate at the nominal
treatment distance more than twice the maximum value specified by the
manufacturer, a device shall be provided which terminates irradiation when the
air kerma rate or absorbed dose rate exceeds a value twice the specified
maximum. The dose rate at which the irradiation will be terminated shall be a
record maintained by the registrant;
9.19.9.1.3. If the equipment can deliver
under any fault condition(s) an air kerma rate or absorbed dose rate at the
nominal treatment distance more than 10 times the maximum value specified by
the manufacturer, a device shall be provided to prevent the air kerma rate or
absorbed dose rate anywhere in the radiation field from exceeding twice the
specified maximum value and to terminate irradiation if the excess absorbed
dose at the nominal treatment distance exceeds 4 Gy (400 rad); and
9.19.9.1.4. For each therapeutic radiation
machine, the registrant shall determine, or obtain from the manufacturer, the
maximum value(s) specified in Section
9.19.9.1.2 and Section
9.19.9.1.3 for the specified
operating conditions. Records of these maximum value(s) shall be maintained at
the installation for inspection by the Department.
9.19.10. Termination of
Irradiation by the Beam Monitoring System or Systems During Stationary Beam
Radiation Therapy
9.19.10.1. Each primary
system shall terminate irradiation when the pre-selected number of dose monitor
units has been detected by the system.
9.19.10.2. If the original design of the
equipment included a secondary dose monitoring system, that system shall be
capable of terminating irradiation when not more than 15% or 40 dose monitor
units above the pre-selected number of dose monitor units set at the control
panel has been detected by the secondary dose monitoring system.
9.19.10.3. For equipment manufactured after
January 1, 1985, an indicator on the control panel shall show which monitoring
system has terminated irradiation.
9.19.11. Termination of Irradiation
9.19.11.1. It shall be possible to terminate
irradiation and equipment movement or go from an interruption condition to
termination condition at any time from the operator's position at the treatment
control panel.
9.19.12.
Interruption of Irradiation
9.19.12.1. If a
therapeutic radiation machine has an interrupt mode:
9.19.12.1.1. It shall be possible to
interrupt irradiation and equipment movements at any time from the treatment
control panel;
9.19.12.1.2.
Following an interruption, it shall be possible to restart irradiation by
operator action without any re-selection of operating conditions; and
9.19.12.1.3. If any change is made of a
pre-selected value during an interruption, irradiation and equipment movements
shall be automatically terminated.
9.19.13. Timer
9.19.13.1. An irradiation control device that
will terminate the irradiation after a pre-set time interval shall be
provided.
9.19.13.2. A timer shall
be provided which has a display at the treatment control panel. The timer shall
have a pre-set time selector and an elapsed time indicator.
9.19.13.3. The timer shall be a cumulative
timer which activates with an indication of "BEAM-ON" 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.
9.19.13.4.
The timer shall terminate irradiation when a pre-selected time has elapsed, if
the dose monitoring systems have not previously terminated irradiation.
9.19.14. Selection of
Radiation Type
9.19.14.1. Equipment capable
of both x-ray therapy and electron therapy shall meet the following additional
requirements:
9.19.14.1.1. Irradiation shall
not be possible until a selection of radiation type (x-rays or electrons) has
been made at the treatment control panel;
9.19.14.1.2. The radiation type selected
shall be displayed at the treatment control panel before and during
irradiation;
9.19.14.1.3. An
interlock system shall be provided to ensure that the equipment can principally
emit only the radiation type which has been selected;
9.19.14.1.4. An interlock system shall be
provided to prevent irradiation with x-rays, except to obtain an image, when
electron applicators are fitted;
9.19.14.1.5. An interlock system shall be
provided to prevent irradiation with electrons when accessories specific for
x-ray therapy are fitted; and
9.19.14.1.6. 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 control panel.
9.19.15. Selection of Energy
9.19.15.1. Equipment capable of generating
radiation beams of different energies shall meet the following requirements:
9.19.15.1.1. Irradiation shall not be
possible until a selection of energy has been made at the treatment control
panel;
9.19.15.1.2. The nominal
energy value selected shall be displayed at the treatment control panel until
reset manually for the next irradiation. After termination of irradiation, it
shall be necessary to reset the nominal energy value selected before subsequent
treatment can be initiated;
9.19.15.1.3. Irradiation shall not be
possible until the appropriate flattening filter or scattering foil for the
selected energy is in its proper location; and
9.19.15.1.4. For equipment manufactured after
July 1, 1999, the selection of energy shall comply with International
Electrotechnical Commission (IEC) Document 601-2-1 (Edition 3.1 - July
2014).
9.19.16.
Selection of Stationary Beam Radiation Therapy or Moving Beam Radiation Therapy
9.19.16.1. Therapeutic radiation machines
capable of both stationary beam radiation therapy and moving beam radiation
therapy shall meet the following requirements:
9.19.16.1.1. Irradiation shall not be
possible until a selection of stationary beam radiation therapy or moving beam
radiation therapy has been made at the treatment control panel.
9.19.16.1.2. The mode of operation shall be
displayed at the treatment control panel.
9.19.16.1.3. An interlock system shall be
provided to ensure that the equipment can operate only in the mode which has
been selected.
9.19.16.1.4. An
interlock system shall be provided to prevent irradiation if any selected
parameter in the treatment room does not agree with the selected parameter at
the treatment control panel.
9.19.16.1.5. Moving beam radiation therapy
shall be controlled to obtain the selected relationships between incremental
dose monitor units and incremental movement:
9.19.16.1.5.1. For equipment manufactured
after January 1, 1985:
9.19.16.1.5.1.1. Where
angle terminates the irradiation in moving beam radiation therapy, the dose
monitor units delivered shall differ by less than 5% from the dose monitor unit
value selected;
9.19.16.1.5.1.2. An
interlock shall be provided to prevent motion of more than 5 degrees or 1
centimeter beyond the selected limits during moving beam radiation
therapy;
9.19.16.1.5.1.3. An
interlock shall be provided to require that a selection of direction be made at
the treatment control panel in all units which are capable of both clockwise
and counter-clockwise moving beam radiation therapy.
9.19.16.1.5.2. For equipment manufactured
after July 1, 1999:
9.19.16.1.5.2.1. An
interlock system shall be provided to terminate irradiation if the number of
dose monitor units delivered in any 10 degrees of rotation or 1 centimeter of
linear motion differs by more than 20% from the selected value;
9.19.16.1.5.2.2. Moving beam radiation
therapy shall be controlled with both primary position sensors and secondary
position sensors to obtain the selected relationships between incremental dose
monitor units and incremental movement.
9.19.16.1.6. Where the beam monitor system
terminates the irradiation in moving beam radiation therapy, the termination of
irradiation shall be as required by Section
9.19.10.
9.19.16.1.7. An interlock system shall be
provided to terminate irradiation if movement:
9.19.16.1.7.1. Occurs during stationary beam
radiation therapy; or
9.19.16.1.7.2. Does not start or stops during
moving beam radiation therapy unless such stoppage is a pre-planned
function.
9.19.17. Facility Design Requirements for
Therapeutic Radiation Machines Operating Above 500 kV
9.19.17.1. In addition to shielding adequate
to meet requirements of Section
9.8, the following design requirements shall
be made:
9.19.17.1.1. Protective Barriers. All
protective barriers shall be fixed, except for access doors to the treatment
room or movable beam interceptors.
9.19.17.1.2. Control Panel. In addition to
other requirements specified in this Section, the control panel shall also:
9.19.17.1.2.1. Be located outside the
treatment room;
9.19.17.1.2.2.
Provide an indication of whether electrical power is available at the control
panel and if activation of the radiation is possible;
9.19.17.1.2.3. Provide an indication of
whether radiation is being produced; and
9.19.17.1.2.4. Include an access control
(locking) device which will prevent unauthorized use of the therapeutic
radiation machine. This locking device may be in the form of computer software
requiring a password for access.
9.19.17.1.3. Viewing Systems. Windows,
mirrors, closed-circuit television or an equivalent viewing system shall be
provided to permit continuous observation of the patient/human research subject
following positioning and during irradiation and shall be so located that the
operator may observe the patient/human research subject from the treatment
control panel.
9.19.17.1.3.1. The therapeutic
radiation machine shall not be used for patient/human research subject
irradiation unless at least one viewing system is operational.
9.19.17.1.4. Aural Communications.
Provision shall be made for continuous two-way aural communication between the
patient/human research subject and the operator at the control panel.
9.19.17.1.4.1. The therapeutic radiation
machine shall not be used for irradiation of patients/human research subjects
unless continuous two-way aural communication is possible.
9.19.17.1.5. Room Entrances. Treatment room
entrances shall be provided with warning lights in a readily observable
position near the outside of all access doors, which will indicate whether the
useful beam is "ON."
9.19.17.1.6.
Entrance Interlocks. Interlocks shall be provided such that all access controls
are activated before treatment can be initiated or continued.
9.19.17.1.6.1. If the radiation beam is
interrupted by any access control, it shall not be possible to restore the
machine to operation without resetting the access control and reinitiating
irradiation by manual action at the control panel.
9.19.17.1.7. Beam Interceptor Interlocks. If
the shielding material in any protective barrier requires the presence of a
beam interceptor to ensure compliance with Section
7.6, interlocks shall be provided to prevent
the production of radiation, unless the beam interceptor is in place, whenever
the useful beam is directed at the designated barrier(s).
9.19.17.1.8. Emergency Cutoff Switches. At
least 1 emergency power cutoff switch shall be located in the radiation therapy
room and shall terminate all equipment electrical power including radiation and
mechanical motion for the radiation producing unit. This switch is in addition
to the termination switch required by Section
9.19.11.
9.19.17.1.8.1. All emergency power cutoff
switches shall include a manual reset so that the therapeutic radiation machine
cannot be restarted from the unit's control console without resetting the
emergency cutoff switch.
9.19.17.1.9. Safety Interlocks. All safety
interlocks shall be designed so that any defect or component failure in the
safety interlock system prevents or terminates operation of the therapeutic
radiation machine.
9.19.17.1.10.
Surveys for Residual Radiation. Surveys for residual activity shall be
conducted on all therapeutic radiation machines capable of generating photon
and electron energies above 10 MV prior to machining, removing, or working on
therapeutic radiation machine components which may have become activated due to
photo-neutron production.
9.19.18. Qualified Medical Physicist Support
9.19.18.1. The services of a Qualified
Medical Physicist shall be required in facilities having therapeutic radiation
machines with energies of 500 kV and above. The Qualified Medical Physicist
shall be responsible for:
9.19.18.1.1. Full
calibration(s) required by Section
9.19.20 and protection surveys required
by Section
9.9.1;
9.19.18.1.2. General supervision and review
of medical dosimetry/treatment planning;
9.19.18.1.3. Beam data acquisition and
transfer for computerized dosimetry, and general supervision of its
use;
9.19.18.1.4. Quality
assurance, including quality assurance check review required by Section
9.19.21.5;
9.19.18.1.5. Consultation with the Radiation
oncologist or radiation therapy physician in treatment planning, as needed;
and
9.19.18.1.6. Performing
calculations/assessments regarding misadministrations.
9.19.18.2. The operating procedures required
by Section
9.19.19 shall also specifically address
how the Qualified Medical Physicist is to be contacted for problems or
emergencies, as well as the specific actions, if any, to be taken until the
Qualified Medical Physicist can be contacted.
9.19.19. Operating Procedures
9.19.19.1. The following operating procedures
shall be required:
9.19.19.1.1. No
individual, other than the patient/human research subject, shall be in the
treatment room during treatment or during any irradiation for testing or
calibration purposes.
9.19.19.1.2.
Therapeutic radiation machines shall not be made available for medical use
unless the requirements of Section
9.9.1, Section
9.19.20, and Section
9.19.21 have been met.
9.19.19.1.3. Therapeutic radiation machines,
when not in operation, shall be secured to prevent unauthorized use. This may
be by means of physical devices (e.g. keys) or software (password
requirement).
9.19.19.1.4. When
adjustable beam limiting devices are used, the position and shape of the
radiation field shall be indicated by a light field.
9.19.19.1.5. If a patient/human research
subject must be held in position during treatment, mechanical supporting or
restraining devices shall be used.
9.19.19.2. A copy of the current operating
and emergency procedures shall be maintained at the therapeutic radiation
machine control console.
9.19.20. Acceptance Testing, Commissioning,
and Full Calibration Measurements
9.19.20.1.
Acceptance testing, commissioning and full calibration of a therapeutic
radiation machine subject to Section
9.19 shall be performed by, or under the
direct supervision of, a Qualified Medical Physicist.
9.19.20.2. Acceptance testing and
commissioning shall be performed in accordance with "AAPM Code of Practice for
Radiotherapy Accelerators: AAPM Report No. 47", prepared by AAPM Radiation
Therapy Task Group 45 (or a superseding document published by the same
organization), and the manufacturer's contractual specifications. Acceptance
testing and commissioning shall be conducted before the first medical use
following installation or reinstallation of the therapeutic radiation
machine.
9.19.20.3. Full
calibration shall include measurement of all applicable parameters required by
"Quality Assurance of Medical Accelerators: AAPM Report No. 142" and shall be
performed in accordance with "AAPM Code of Practice for Radiotherapy
Accelerators: AAPM Report No. 47" (or a superseding document published by the
same organization), prepared by AAPM Radiation Therapy Task Group 45. Although
it shall not be necessary to complete all elements of a full calibration at the
same time, all applicable parameters (for all energies) shall be completed at
intervals not exceeding 14 calendar months, unless a more frequent interval is
required in AAPM Report No. 142 (or a superseding document published by the
same organization).
9.19.20.3.1. AAPM Report
142 supersedes Table II of "Comprehensive QA for Radiation Oncology: AAPM
Report No. 46", prepared by AAPM Radiation Therapy Task Group 40.
9.19.20.4. The Qualified Medical
Physicist shall perform or directly supervise all elements of a full
calibration necessary to determine that all parameters are within acceptable
limits:
9.19.20.4.1. Whenever quality
assurance check measurements indicate that the radiation output differs by more
than 5% from the value obtained at the last full calibration and the difference
cannot be reconciled. Therapeutic radiation machines with multi-energy and/or
multi-mode capabilities shall only require measurements for those modes and/or
energies that are not within their acceptable range; and
9.19.20.4.2. Following any component
replacement, major repair, or modification of components that could
significantly affect the characteristics of the radiation beam. If the repair,
replacement or modification does not affect all modes and/or energies,
measurements shall be performed on the affected mode/energy that is in most
frequent clinical use at the facility. The remaining energies/modes may be
validated with quality assurance check procedures against the criteria in
Section 9.19.20.4.1.
9.19.20.5. The registrant shall use the
dosimetry system described in Section
9.12.1 to measure the radiation output
for one set of exposure conditions. The remaining radiation measurements
required in Section
9.19.20.2, Section
9.19.20.3, and Section
9.19.20.4 may then be made using a
dosimetry system that indicates relative dose rates.
9.19.20.6. The registrant shall maintain a
record of each calibration in an auditable form for the duration of the
registration. The record shall include:
9.19.20.6.1. The date of the
calibration;
9.19.20.6.2. The
manufacturer's name;
9.19.20.6.3.
Model and serial number of the therapeutic machine;
9.19.20.6.4. The model numbers and serial
numbers of the instruments used to calibrate the therapeutic radiation machine;
and
9.19.20.6.5. The signature of
the Radiation Therapy Physicist responsible for performing the
calibration.
9.19.20.7.
Therapy-Related Computer Systems The registrant shall perform acceptance
testing on the treatment planning system of therapeutic radiation
machine-related computer systems in accordance with current published
recommendations from the American Association of Physicists in Medicine. In the
absence of an acceptance testing protocol published by the American Association
of Physicists in Medicine, the manufacturer's acceptance testing protocol shall
be followed.
9.19.20.7.1. Acceptance testing
shall be performed by, or under the direct supervision of, a Qualified Medical
Physicist. At a minimum, the acceptance testing shall include, as applicable,
verification of:
9.19.20.7.1.1. The
source-specific input parameters required by the dose calculation
algorithm;
9.19.20.7.1.2. The
accuracy of dose calculations at representative points;
9.19.20.7.1.3. The accuracy of isodose plots
and graphic displays;
9.19.20.7.1.4. The accuracy of the software
used to determine radiation source positions from radiographic images;
and
9.19.20.7.1.5. 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 from the treatment planning system.
9.19.20.7.2. Prior to each patient
treatment regimen, the parameters for the treatment shall be evaluated and
approved by the Qualified Medical Physicist, and either the Radiation
Oncologist or the radiation therapy physician for correctness through means
independent of that used for the determination of the parameters.
9.19.21. Periodic
Quality Assurance Checks
9.19.21.1. Periodic
quality assurance checks shall be performed on all therapeutic radiation
machines subject to Section
9.19 at intervals not to exceed those
specified in "Comprehensive QA for Radiation Oncology: AAPM Report No. 46,
prepared by AAPM Radiation Therapy Committee Task Group 40. All periodic
quality assurance checks with an annual frequency do not have to be performed
at the same time but shall be completed during an interval not to exceed 12
consecutive calendar months.
9.19.21.2. The registrant shall use a
dosimetry system which has been inter-compared within the previous 12 months
with the dosimetry system described in Section
9.12.1 to make the periodic quality
assurance checks required in Section
9.19.21.1.
9.19.21.3. The registrant shall perform
periodic quality assurance checks required by Section
9.19.21.1 in accordance with
procedures established by the Qualified Medical Physicist.
9.19.21.4. The registrant shall review the
results of each periodic radiation output check according to the following
procedures:
9.19.21.4.1. The Radiation
Oncologist, radiation therapy physician or Qualified Medical Physicist shall be
immediately notified if any parameter is not within its acceptable tolerance.
The therapeutic radiation machine shall not be made available for subsequent
medical use until the Qualified Medical Physicist has determined that all
parameters are within their acceptable tolerances;
9.19.21.4.2. If all radiation output quality
assurance check parameters appear to be within their acceptable range, the
quality assurance check shall be reviewed and signed by either the Radiation
Oncologist, radiation therapy physician or Qualified Medical Physicist within 3
treatment days; and
9.19.21.4.3. The
Qualified Medical Physicist shall review and sign the results of each radiation
output quality assurance check at intervals not to exceed 30 days.
9.19.21.5. Therapeutic radiation
machines subject to Section
9.19 shall have the following safety
quality assurance checks performed at intervals not to exceed 1 week:
9.19.21.5.1. Proper operation of the
"BEAM-ON", interrupt and termination switches;
9.19.21.5.2. Beam condition indicator lights
on the access doors, control console, and in the radiation therapy
room;
9.19.21.5.3. Electrically
operated treatment room door(s) from inside and outside the treatment
room.
9.19.21.6. The
registrant shall promptly repair any system identified in Section
9.19.21.1 and Section
9.19.21.5 that is not operating
properly.
9.19.21.7. The registrant
shall maintain a record of each quality assurance check required by Section
9.18.21.1 and Section
9.18.21.5 for 3 years. The record
shall include:
9.19.21.7.1. The date of the
quality assurance check;
9.19.21.7.2. The manufacturer's
name;
9.19.21.7.3. The machine
model and serial number;
9.19.21.7.4. The manufacturer's name, model
number, and serial number of the instrument(s) used to measure the radiation
output of the therapeutic radiation machine; and
9.19.21.7.5. The signature of the individual
who performed the periodic quality assurance check.
9.19.22. Quality Assurance Checks
for Intensity Modulated Radiation Therapy (IMRT)
9.19.22.1. Quality assurance checks for IMRT
shall:
9.19.22.1.1. Include commissioning and
testing of the treatment planning and delivery systems, routine quality
assurance of the delivery system, and patient-specific validation of treatment
plans; and
9.19.22.1.1.1. IMRT is a rapidly
evolving modality and the QA program shall also evolve to handle new issues
that arise. "Guidance document on delivery, treatment planning, and clinical
implementation of IMRT: AAPM Report No. 82", prepared by the IMRT subcommittee
of the AAPM radiation therapy committee, provides some suggestions on
establishing such a QA program.
9.19.22.1.2. Be performed in accordance with
the manufacturer's contractual specifications.
9.20. Quality Assurance for
Radiation Therapy Simulation Systems
9.20.1.
Quality assurance for a conventional or virtual simulator shall include
acceptance testing and periodic verification of system performance;
and
9.20.2. Be performed in
accordance with "Comprehensive QA for Radiation Oncology: AAPM Report No. 46",
prepared by AAPM Radiation Therapy Committee Task Group 40, for a conventional
simulator; or
9.20.3. Be performed
in accordance with "Quality assurance for computed tomography simulators and
the computed tomography-simulation process: AAPM Report No. 83", prepared by
AAPM Radiation Therapy Committee Task Group 66, for a virtual
simulator.
9.21.
Electronic Brachytherapy
9.21.1.
Applicability
9.21.1.1. Electronic
brachytherapy devices shall be subject to the requirements of this Section and
shall be exempt from the requirements of Section
9.18.
9.21.1.2. An electronic brachytherapy device
that does not meet the requirements of this Section shall not be used for
irradiation of patients.
9.21.1.3.
An electronic brachytherapy device shall only be utilized for human use
applications specifically approved by the U.S. Food and Drug Administration
(FDA) unless participating in a research study approved by the registrant's
Institutional Review Board (IRB).
9.21.2. Possession of Survey Instrument(s)
9.21.2.1. Each facility location authorized
to use an electronic brachytherapy device in accordance with Section
9.21 shall possess appropriately calibrated
portable monitoring equipment which shall as a minimum:
9.21.2.1.1. Include a portable radiation
measurement survey instrument capable of measuring dose rate over the range of
10 mSv (1 mrem) per hour to 10 mSv (1000 mrem) per hour, and
9.21.2.1.2. Be operable and calibrated in
accordance with Section
9.11 for the applicable electronic
brachytherapy source energy.
9.21.3. Facility Design Requirements for
Electronic Brachytherapy Devices
9.21.3.1. In
addition to shielding adequate to meet requirements of Section
9.8, the treatment room shall meet the
following design requirements:
9.21.3.1.1. If
applicable, provision shall be made to prevent simultaneous operation of more
than one therapeutic radiation machine in a treatment room.
9.21.3.1.2. Access to the treatment room
shall be controlled by a door at each entrance.
9.21.3.1.3. Each treatment room shall have
provisions to permit continuous aural communication and visual observation of
the patient from the treatment control panel during irradiation. The electronic
brachytherapy device shall not be used for patient irradiation unless the
patient can be observed.
9.21.3.1.4. For electronic brachytherapy
devices capable of operating below 50 kV, radiation shielding for the staff in
the treatment room shall be available, either as a portable shield and/or as
localized shielded material around the treatment site.
9.21.3.1.5. For electronic brachytherapy
devices capable of operating at greater than 150 kV:
9.21.3.1.5.1. The control panel shall be
located outside the treatment room;
9.21.3.1.5.2. 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 electronic brachytherapy device to
operation without closing the door and reinitiating irradiation by manual
action at the control panel; and
9.21.3.1.5.3. When any door referred to in
Section 9.21.3.1.5.2 is
opened while the x-ray tube is activated, the air kerma rate at a distance of 1
meter from the source shall be reduced to less than 1 mGy (100 mrad) per
hour.
9.21.4. Electrical Safety for Electronic
Brachytherapy Devices
9.21.4.1. The high
voltage transformer shall be electrically isolated to prevent electrical and
magnetic interference with the surrounding environment and ancillary
equipment.
9.21.4.2. The high
voltage transformer shall be isolated from personnel (e.g., operator) and the
environment by a protective housing that can only be accessed through a cover
requiring a tool for access or with electrical interlocks to prevent operation
while open.
9.21.4.3. The high
voltage transformer shall have appropriate safety labels warning personnel of
potential electrical shock and/or heat related injuries.
9.21.4.4. Equipment manufactured after
January 1, 2006 shall be in compliance with the most current revision of the
following International Electrotechnical Commission (IEC) Documents:
9.21.4.4.1. IEC
60601-1:1998+A1+A2:1995;
9.21.4.4.2. IEC 60601-1-2:2001;
9.21.4.4.3. IEC 60601-2-8:1999; and
9.21.4.4.4. IEC 60601-2-17:2004.
9.21.5. Control Panel
Functions
9.21.5.1. The control panel, in
addition to the displays required by other provisions in Section
9.21, shall:
9.21.5.1.1. Provide an indication of whether
electrical power is available at the control panel and if activation of the
electronic brachytherapy source is possible;
9.21.5.1.2. Provide an indication of whether
x rays are being produced;
9.21.5.1.3. Provide a means for indicating
electronic brachytherapy source potential and current;
9.21.5.1.4. Provide the means for terminating
an exposure at any time; and
9.21.5.1.5. Include an access control
(locking) device that will prevent unauthorized use of the electronic
brachytherapy device.
9.21.6. Timer
9.21.6.1. A suitable irradiation control
device (timer) shall be provided to terminate the irradiation after a pre-set
time interval or integrated charge on a dosimeter-based monitor.
9.21.6.2. A timer shall be provided at the
treatment control panel. The timer shall indicate the planned setting and the
time elapsed or remaining.
9.21.6.3. The timer shall not permit an
exposure if set at zero.
9.21.6.4.
The timer shall be a cumulative device that activates with an indication of
"BEAM-ON" 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.
9.21.6.5. The timer
shall terminate irradiation when a pre-selected time has elapsed, if any dose
monitoring system has not previously terminated irradiation.
9.21.6.6. The timer shall permit setting of
exposure times as short as 0.1 second.
9.21.6.7. The timer shall be accurate to
within 1% of the selected value or 0.1 second, whichever is greater.
9.21.7. Qualified Medical
Physicist Support
9.21.7.1. The services of a
Qualified Medical Physicist shall be required in facilities having electronic
brachytherapy devices. The Qualified Medical Physicist shall be responsible
for:
9.21.7.1.1. Evaluation of the output from
the electronic brachytherapy source;
9.21.7.1.2. Generation of the necessary
dosimetric information;
9.21.7.1.3.
Supervision and review of treatment calculations prior to initial treatment of
any treatment site;
9.21.7.1.4.
Establishing the periodic and day-of-use quality assurance checks and reviewing
the data from those checks as required in Section
9.21.11;
9.21.7.1.5. Consultation with the Radiation
Oncologist or radiation therapy physician in treatment planning, as needed;
and
9.21.7.1.6. Performing
calculations/assessments regarding patient treatments that may constitute a
misadministration.
9.21.7.2. If the Qualified Medical Physicist
is not a full-time employee of the registrant, the operating procedures
required by Section
9.21.8 shall also specifically address
how the Qualified Medical Physicist is to be contacted for problems or
emergencies, as well as the specific actions, if any, to be taken until the
Qualified Medical Physicist can be contacted.
9.21.8. Operating Procedures
9.21.8.1. Operating procedures shall be as
follows:
9.21.8.1.1. Only individuals approved
by the Radiation Oncologist, radiation therapy physician, Radiation Safety
Officer, or Qualified Medical Physicist shall be present in the treatment room
during treatment;
9.21.8.1.2.
Electronic brachytherapy devices shall not be made available for medical use
unless the requirements of Sections
9.9 through
9.13,
9.21.9, and 9.21.10 have been
met;
9.21.8.1.3. The electronic
brachytherapy device shall be rendered inoperable, either by hardware or
password, when unattended by qualified staff or service personnel;
9.21.8.1.4. During operation, the electronic
brachytherapy device operator shall monitor the position of all persons in the
treatment room, and all persons entering the treatment room, to prevent
unshielded exposure from the treatment beam;
9.21.8.1.5. If a patient must be held in
position during treatment, mechanical supporting or restraining devices shall
be used;
9.21.8.1.6. Written
procedures shall be developed, implemented, and maintained for responding to an
abnormal situation. These procedures shall include:
9.21.8.1.6.1. Instructions for responding to
equipment failures and the names of the individuals responsible for
implementing corrective actions; and
9.21.8.1.6.2. The names and telephone numbers
of the Radiation Oncologist, radiation therapy physician, Qualified Medical
Physicist, and the Radiation Safety Officer to be contacted if the device or
console operates abnormally.
9.21.8.1.7. A copy of the current operating
and emergency procedures shall be physically located at the electronic
brachytherapy device control console;
9.21.8.1.7.1. If the control console is
integral to the electronic brachytherapy device, the required procedures shall
be kept where the operator is located during electronic brachytherapy device
operation.
9.21.8.1.8.
Instructions shall be posted at the electronic brachytherapy device control
console to inform the operator of the names and telephone numbers of the
Radiation Oncologist, radiation therapy physician, Qualified Medical Physicist,
and the Radiation Safety Officer to be contacted if the device or console
operates abnormally; and
9.21.8.1.9. The Radiation Safety Officer, or
their designee, and a Radiation Oncologist or radiation therapy physician shall
be notified as soon as possible if the patient has a medical emergency, suffers
injury or dies. The Radiation Safety Officer or the Qualified Medical Physicist
shall inform the manufacturer of the event.
9.21.9. Safety Precautions for Electronic
Brachytherapy Devices
9.21.9.1. A Qualified
Medical Physicist shall determine which persons in the treatment room require
monitoring when the beam is energized;
9.21.9.2. A Qualified Medical Physicist and
either a Radiation Oncologist or a radiation therapy physician shall be
physically present during the initiation of all patient treatments involving
the electronic brachytherapy device;
9.21.9.3. A Qualified Medical Physicist and
either a Radiation Oncologist, radiation therapy physician, or a physician or
electronic brachytherapy device operator who has been trained in the operation
and emergency response for the electronic brachytherapy device and is under the
general supervision of a Radiation Oncologist or radiation therapy physician,
shall be physically present during continuation of all patient treatments
involving the electronic brachytherapy device;
9.21.9.4. When shielding is required by
Section 9.21.3.1.4, the
electronic brachytherapy device operator shall use a survey meter to verify
proper placement of the shielding immediately upon initiation of treatment.
Alternatively, a Qualified Medical Physicist shall designate shield locations
sufficient to meet the requirements of Section
7.2 for any individual, other than the
patient, in the treatment room; and
9.21.9.5. All personnel in the treatment room
are required to remain behind shielding during treatment. A Qualified Medical
Physicist shall approve any deviation from this requirement and shall designate
alternative radiation safety protocols, compatible with patient safety, to
provide an equivalent degree of protection.
9.21.10. Electronic Brachytherapy Source
Calibration Measurements
9.21.10.1.
Calibration of the electronic brachytherapy source output for an electronic
brachytherapy device subject to Section
9.21 shall be performed by, or under the
direct supervision of, a Qualified Medical Physicist;
9.21.10.2. Calibration of the electronic
brachytherapy source output shall be made for each electronic brachytherapy
source, or after any repair affecting the x-ray beam generation, or when
indicated by the electronic brachytherapy source quality assurance
checks;
9.21.10.3. Calibration of
the electronic brachytherapy source output shall utilize a dosimetry system as
described in Section
9.12;
9.21.10.4. Calibration of the electronic
brachytherapy source output shall include, as applicable, determination of:
9.21.10.4.1. The output within 2% of the
expected value, if applicable, or determination of the output if there is no
expected value;
9.21.10.4.2. Timer
accuracy and linearity over the typical range of use;
9.21.10.4.3. Proper operation of back-up
exposure control devices;
9.21.10.4.4. Evaluation that the relative
dose distribution about the source is within 5% of that expected; and
9.21.10.4.5. Source positioning accuracy to
within 1 millimeter within the applicator;
9.21.10.5. Calibration of the x-ray source
output required by Section
9.21.10.1 through Section
9.21.10.4 shall be in accordance with
current published recommendations from a recognized national professional
association, such as AAPM, with expertise in electronic brachytherapy (if
available). In the absence of a calibration protocol published by a national
professional association, the manufacturer's calibration protocol shall be
followed.
9.21.10.6. The registrant
shall maintain a record of each calibration in an auditable form for the
duration of the registration. The record shall include:
9.21.10.6.1. The date of the
calibration;
9.21.10.6.2. The
manufacturer's name, model number and serial number for the electronic
brachytherapy device and a unique identifier for its electronic brachytherapy
source;
9.21.10.6.3. The model
numbers and serial numbers of the instrument(s) used to calibrate the
electronic brachytherapy device; and
9.21.10.6.4. The name and signature of the
Qualified Medical Physicist responsible for performing the calibration.
9.21.11.
Periodic and Day-of-Use Quality Assurance Checks for Electronic Brachytherapy
Devices
9.21.11.1. Quality assurance checks
shall be performed on each electronic brachytherapy device subject to Section
9.21:
9.21.11.1.1. At the beginning of each day of
use;
9.21.11.1.2. After each x-ray
tube installation; and
9.21.11.1.3.
Each time the device is moved to a new room or site;
9.21.11.1.3.1. Site is intended to include
each day of use at each operating location for a self-contained electronic
brachytherapy unit transported in a van or trailer. See Section
9.21.14 for additional
clarification.
9.21.11.2. The registrant shall perform
periodic quality assurance checks required by Section
9.21.11.1 in accordance with
procedures established by the Qualified Medical Physicist;
9.21.11.3. To satisfy the requirements of
Section 9.21.11.1,
radiation output quality assurance checks shall include as a minimum:
9.21.11.3.1. Verification that output of the
electronic brachytherapy source falls within 3% of expected values, as
appropriate for the device, as determined by:
9.21.11.3.1.1. Output as a function of time,
or
9.21.11.3.1.2. Output as a
function of setting on a monitor chamber.
9.21.11.3.2. Verification of the consistency
of the dose distribution to within 3% of that found during calibration required
by Section
9.21.10; and
9.21.11.3.3. Validation of the operation of
positioning methods to ensure that the treatment dose exposes the intended
location within 1 millimeter; and
9.21.11.4. The registrant shall use a
dosimetry system that has been intercompared within the previous 12 months with
the dosimetry system described in Section
9.12.1 to make the quality assurance
checks required in Section
9.21.11.3;
9.21.11.5. The registrant shall review the
results of each radiation output quality assurance check according to the
following procedures:
9.21.11.5.1. A Radiation
Oncologist or radiation therapy physician and a Qualified Medical Physicist
shall be immediately notified if any parameter is not within its acceptable
tolerance. The electronic brachytherapy device shall not be made available for
subsequent medical use until the Qualified Medical Physicist has determined
that all parameters are within their acceptable tolerances;
9.21.11.5.2. If all radiation output quality
assurance check parameters appear to be within their acceptable range, the
quality assurance check shall be reviewed and signed by either the Radiation
Oncologist or radiation therapy physician, or Qualified Medical Physicist
within 2 days; and
9.21.11.5.3. The
Qualified Medical Physicist shall review and sign the results of each radiation
output quality assurance check at intervals not to exceed 30 days.
9.21.11.6. To satisfy the
requirements of Section
9.21.11.1, safety device quality
assurance checks shall, at a minimum, ensure:
9.21.11.6.1. Proper operation of radiation
exposure indicator lights on the electronic brachytherapy device and on the
control console;
9.21.11.6.2.
Proper operation of viewing and intercom systems in each electronic
brachytherapy facility, if applicable;
9.21.11.6.3. Proper operation of radiation
monitors, if applicable;
9.21.11.6.4. The integrity of all cables,
catheters or parts of the device that carry high voltages; and
9.21.11.6.5. Connecting guide tubes, transfer
tubes, transfer-tube-applicator interfaces, and treatment spacers are free from
any defects that interfere with proper operation.
9.21.11.7. If the results of the safety
device quality assurance checks required in Section
9.21.11.6 indicate any malfunction, a
registrant shall secure the control console in the "OFF" position and not use
the electronic brachytherapy device except as may be necessary to repair,
replace, or check the malfunctioning items.
9.21.11.8. The registrant shall maintain a
record of each quality assurance check required by Section
9.21.11.3 and Section
9.21.11.7 in an auditable form for 3
years. The record shall include:
9.21.11.8.1.
Date of the quality assurance check;
9.21.11.8.2. Manufacturer's name, model
number and serial number for the electronic brachytherapy device;
9.21.11.8.3. Name and signature of the
individual who performed the periodic quality assurance check; and
9.21.11.8.4. Name and signature of the
Qualified Medical Physicist who reviewed the quality assurance check.
9.21.11.8.5. For radiation output quality
assurance checks required by Section
9.21.11.3, the record shall also
include:
9.21.11.8.5.1. The unique identifier
for the electronic brachytherapy source; and
9.21.11.8.5.2. The manufacturer's name, model
number and serial number for the instrument(s) used to measure the radiation
output of the electronic brachytherapy device.
9.21.12. Therapy-Related
Computer Systems
9.21.12.1. The registrant
shall perform acceptance testing on the treatment planning system of electronic
brachytherapy-related computer systems in accordance with current published
recommendations from a recognized national professional association, such as
AAPM, with expertise in electronic brachytherapy (when available).
9.21.12.1.1. In the absence of an acceptance
testing protocol published by a national professional association, the
manufacturer's acceptance testing protocol shall be followed.
9.21.12.2. Acceptance testing
shall be performed by, or under the direct supervision of, a Qualified Medical
Physicist. At a minimum, the acceptance testing shall include, as applicable,
verification of:
9.21.12.2.1. The
source-specific input parameters required by the dose calculation
algorithm;
9.21.12.2.2. The accuracy
of dose, dwell time, and treatment time calculations at representative
points;
9.21.12.2.3. The accuracy
of isodose plots and graphic displays;
9.21.12.2.4. The accuracy of the software
used to determine radiation source positions from radiographic images;
and
9.21.12.2.5. 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 from the treatment planning system.
9.21.12.3. The position indicators in the
applicator shall be compared to the actual position of the source or planned
dwell positions, as appropriate, at the time of commissioning.
9.21.12.4. Prior to each patient treatment
regimen, the parameters for the treatment shall be evaluated and approved by
the Radiation Oncologist or radiation therapy physician and the Qualified
Medical Physicist for correctness through means independent of that used for
the determination of the parameters.
9.21.13. Training
9.21.13.1. A registrant shall provide
instruction, initially and at intervals not to exceed 12 months, to all
individuals who operate the electronic brachytherapy device, as appropriate to
the individual's assigned duties, in the operating procedures identified in
Section 9.21.8.
9.21.13.1.1. If the interval between patients
exceeds one year, retraining of the individuals shall be provided before the
next treatment is administered.
9.21.13.2. Radiation Oncologists, radiation
therapy physicians and Qualified Medical Physicists shall also receive device
specific instruction initially from the manufacturer, and at intervals not to
exceed 12 months from either the manufacturer or other qualified trainer. The
training shall be of a duration recommended by a recognized national
professional association with expertise in electronic brachytherapy (when
available), such as AAPM. In the absence of any training protocol recommended
by a national professional association, the manufacturer's training protocol
shall be followed. The training shall include, but not be limited to:
9.21.13.2.1. Device-specific radiation safety
requirements;
9.21.13.2.2. Device
operation;
9.21.13.2.3. Clinical
use for the types of use approved by the FDA;
9.21.13.2.4. Emergency procedures, including
an emergency drill; and
9.21.13.2.5. The registrant's Quality
Assurance Program.
9.21.13.3. A registrant shall retain a record
of individuals receiving instruction required by Section
9.21.13.1 and Section
9.21.13.2 for 3 years. The record
shall include a list of the topics covered, the date of the instruction, the
name(s) of the attendee(s), and the name(s) of the individual(s) who provided
the instruction.
9.21.14.
Mobile Electronic Brachytherapy Service
9.21.14.1. A registrant providing mobile
electronic brachytherapy service shall, as a minimum:
9.21.14.1.1. Check each survey instrument for
consistent response with a dedicated check source before medical use at each
address of use or on each day of use, whichever is more restrictive. The
registrant is not required to keep records of these checks.
9.21.14.1.2. Account for the electronic
brachytherapy source in the electronic brachytherapy device before departure
from the client's address.
9.21.14.1.3. Perform, at each location on
each day of use, all of the required quality assurance checks specified in
Section 9.21.11 to ensure
proper operation of the device.
9.22. Other Use of Electronically Produced
Radiation to Deliver Therapeutic Radiation Dosage
9.22.1. Prohibition on Use
9.22.1.1. A person shall not utilize any
device which is designed to electrically generate a source of ionizing
radiation to deliver therapeutic radiation dosage, and which is not
appropriately regulated under any existing category of therapeutic radiation
machine, until:
9.22.1.1.1. The applicant or
registrant has, at a minimum, provided the Department with:
9.22.1.1.1.1. A detailed description of the
device and its intended application(s);
9.22.1.1.1.2. Facility design requirements,
including shielding and access control;
9.22.1.1.1.3. Documentation of appropriate
training for Radiation Oncologists, radiation therapy physicians and Qualified
Medical Physicist(s);
9.22.1.1.1.4.
Methodology for measurement of dosages to be administered to patients or human
research subjects;
9.22.1.1.1.5.
Documentation regarding calibration, maintenance, and repair of the device, as
well as instruments and equipment necessary for radiation safety;
9.22.1.1.1.6. Radiation safety precautions
and instructions; and
9.22.1.1.1.7.
Other information requested by the Department in its review of the application;
and
9.22.1.1.2. The
applicant or registrant has received written approval from the Department to
utilize the device in accordance with the regulations and specific conditions
the Department considers necessary for the medical use of the device.
10.0 Radiation Safety Requirements for
Radiation Generating Machines Not Used in the Healing Arts.
10.1. Purpose and Scope
10.1.1. This Section establishes
requirements, for which the registrant is responsible, for use of
non-healing-arts radiation generating machines not otherwise covered by this
Rule. The provisions of this Section are in addition to, and not in
substitution for, other applicable provisions of this Rule.
10.1.2. The registrant shall be responsible
for directing the operation of the radiation generating machines which have
been registered with the Department, and for ensuring compliance with this
Rule.
10.2. Applicability
The relevant special requirements of Section
10.0 also apply if an image receptor is
used to transform incident x-ray photons either into a visible image or into
another form that can be made into a visible image by further
transformation.
10.3. Registration
Requirement The owner of a non-healing-arts radiation machine in the State of
Vermont shall register each machine with the Department as required by Section
5.0.
10.4. Equipment Requirements
10.4.1. All open-beam configurations shall be
provided with a safety device which prevents the entry of any portion of an
individual's body into the primary x-ray beam path or which causes the beam to
be shut off upon entry into its path.
10.4.1.1. A registrant may apply to the
Department for an exemption from the requirement of a safety device. An
application for exemption shall include:
10.4.1.1.1. A description of the various
safety devices that have been evaluated;
10.4.1.1.2. The reason each of these devices
cannot be used;
10.4.1.1.3. A
description of the alternative methods that will be employed to minimize the
possibility of an accidental exposure; and
10.4.1.1.4. The procedures followed to ensure
that operators and others in the area will be informed of the absence of safety
devices.
10.4.2. Warning Devices
10.4.2.1. Open-beam configurations shall be
provided with a readily discernible indication of x-ray tube "on-off" status
located near the radiation source housing, if the useful beam is controlled in
this manner.
10.4.2.2. Each
analytical x-ray machine shall have an easily visible warning light labeled
with the words "X-RAY ON" located near any switch that energizes an x-ray tube
and shall be illuminated only when the tube is energized.
10.4.2.3. Warning devices shall be labeled so
that their purpose is easily identified.
10.4.2.4. Warning devices shall have
fail-safe characteristics.
10.4.3. Labeling
10.4.3.1. All analytical x-ray equipment
shall be labeled with a readily discernable sign(s) bearing the radiation
symbol and the words:
10.4.3.1.1. "CAUTION -
HIGH INTENSITY X-RAY BEAM", or words having a similar intent, on the x-ray
source housing; and
10.4.3.1.2.
"CAUTION - RADIATION - THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED", or
words having a similar intent, near any switch that energizes an x-ray
tube.
10.4.4.
Radiation Source Housing
10.4.4.1. Each
radiation machine source housing shall be equipped with an interlock that shuts
off the tube if the tube is removed from the radiation source housing or if the
housing is disassembled.
10.4.4.2.
Each x-ray tube housing shall be so constructed that, with all shutters closed,
the radiation measured at a distance of 5 centimeters from the source housing
at any specified tube rating is not capable of producing a dose in excess of
2.5 millirems (0.025 mSv) in 1 hour.
10.4.5. Each x-ray generator shall be
supplied with a protective cabinet which limits leakage radiation measured at a
distance of 5 centimeters from its surface such that it is not capable of
producing a dose in excess of 0.5 millirem (5 [mu]Sv) in 1 hour.
10.5. Operating Requirements
10.5.1. Normal and emergency operating
procedures shall be written and available to all analytical x-ray equipment
workers. These procedures shall include:
10.5.1.1. Sample insertion and
manipulation;
10.5.1.2. Equipment
alignment;
10.5.1.3. Routine
maintenance procedures to be performed by the registrant; and
10.5.1.4. Data recording procedures, which
are related to radiation safety.
10.5.2. No individual shall be permitted to
operate analytical x-ray equipment in any manner other than that specified in
the procedures unless such individual has obtained written approval of the
registrant's Radiation Safety Officer.
10.5.3. No individual shall bypass a safety
device or interlock unless such individual has obtained written approval of the
Radiation Safety Officer.
10.5.3.1. Such
approval shall be for a specified period of time.
10.5.3.2. When a safety device or interlock
has been bypassed, a sign bearing the words "SAFETY DEVICE NOT WORKING" shall
be placed on the radiation source housing.
10.5.4. Repair or Modification of X-ray Tube
Systems
10.5.4.1. Except as specified in
Section 10.5.3, no operation
involving removal of covers, shielding materials, or tube housings or
modifications to shutters, collimators, or beam stops shall be performed
without ascertaining that the tube is off and will remain off until safe
conditions have been restored.
10.5.4.2. The main switch, rather than
interlocks, shall be used for routine shutdown in preparation for
repairs.
10.5.5. Each
area or room containing analytical x-ray equipment shall be conspicuously
posted with a sign or signs bearing the radiation symbol and the words "CAUTION
- X-RAY EQUIPMENT" or words having a similar intent.
10.5.6. Handheld Devices
10.5.6.1. The operator shall be protected
from direct scatter radiation by material of not less than 0.25 millimeter lead
equivalent unless the Radiation Safety Officer and Department determine that no
added protection is needed for the device use and/or model.
10.6. Personnel
Requirements
10.6.1. No individual shall be
permitted to operate or maintain analytical x-ray equipment unless such
individual has received instruction and demonstrated competence as to:
10.6.1.1. Identification of radiation hazards
associated with the use of the equipment;
10.6.1.2. The significance of the various
radiation warning devices, safety devices, and interlocks incorporated into the
equipment, or the reasons such devices have not been installed on certain
equipment;
10.6.1.3. Any extra
precautions required relevant to the use of the equipment;
10.6.1.4. Proper operating and safety
procedures for the equipment;
10.6.1.5. Recognition of symptoms of an acute
localized exposure; and
10.6.1.6.
Proper procedures for reporting an actual or suspected exposure.
10.6.2. Training for use of Bomb
Detection Radiation Machines
10.6.2.1. In
addition to the requirements of Section
10.5.1, all personnel operating bomb
detection radiation machines shall be trained in the set-up and operation of
the Bomb Detection radiation machine and in establishing a restricted
area.
10.7.
Special Requirements for Security Screening Systems on Humans
10.7.1. In addition to the provisions of
Sections 10.1 through
10.5, security screening systems designed
to admit humans shall comply with the following equipment standards:
10.7.1.1. Indicators that light only when a
scan is in process shall be provided and clearly visible to all security
screening system operators and anyone approaching the restricted
area;
10.7.1.2. Power to the system
shall be controlled by a key switch;
10.7.1.3. A device to terminate x-ray
exposure at any time during a scan shall be provided;
10.7.1.4. Access panels to x-ray source and
detector shall be provided with at least one safety interlock;
10.7.1.5. Operational safety interlocks must
terminate the x-ray exposure in the event of any system problem that could
result in abnormal or unintended radiation emission;
10.7.1.6. Following any premature
termination, the security screening system must prohibit resumption of x-ray
generation until the normal control sequence is reset for a new scan;
10.7.1.7. Equipment designed to control the
exposure output using multiple modes of operation shall indicate the selected
mode prior to each scan;
10.7.1.8.
Technique factors may not be adjustable and shall be preset by the manufacturer
for each mode of operation;
10.7.1.9. A means shall be provided to
terminate the exposure at a preset time interval or exposure;
10.7.1.10. When the x-ray tube is operated at
its maximum rated tube current for the maximum kilovoltage, the leakage dose
shall not be greater than 2.5 mSv (0.25 mrem) in any one hour at any point 30
centimeters from any external surface; and
10.7.1.11. The primary x-ray beam shall be
attenuated by at least one millimeter of aluminum-equivalent total
filtration.
10.7.2.
Operators of security screening systems designed to admit humans shall comply
with the following operating requirements:
10.7.2.1. No individual shall be exposed to
the useful beam unless authorized by a law enforcement agency for security
benefit;
10.7.2.2. No individual
shall be exposed to the useful beam for demonstration or frivolous
purpose;
10.7.2.3. The individual
responsible for radiation protection shall ensure that all operators are
trained in the safe operation of the security screening systems;
10.7.2.4. Any radiation-generating equipment
that does not meet the provisions set forth in this Rule shall not be used to
irradiate individuals unless the Department determines that the continued use
will not pose a radiation risk and arrangements have been made to promptly
correct the deficiency;
10.7.2.5.
The operator shall follow the manufacturer's recommended maintenance
schedule;
10.7.2.6.
Radiation-generating equipment shall bear a warning label on the control panel
or by the exposure switch which cautions individuals that radiation is produced
when it is energized; and
10.7.2.7.
All position locking, holding, and centering devices on radiation-generating
equipment components shall function as designed by the manufacturer.
10.7.3. Each registrant operating
a security screening system shall have a written quality assurance program that
includes the following:
10.7.3.1. Policy
prohibiting the frivolous use of security screening systems where no security
benefit is to be derived;
10.7.3.2.
Policy requiring individuals undergoing screening to be positioned facing away
from the source of radiation when using transmission security screening
systems;
10.7.3.3. Policy requiring
consent to exposure by a pregnant individual;
10.7.3.4. Policy that operator training must
follow the topics listed in the "Personnel Training" section of the American
National Standards Institute publication "ANSI/HPS N43.17-2009 Radiation Safety
for Personnel Security Screening Systems Using X-Ray or Gamma
Radiation."
10.7.3.5. For
general-use full-body security screening systems capable of delivering a
maximum effective dose equivalent less than or equal to 0.1 Sv (10 rem) per
scan: policies and records to show that administrative controls are applied to
limit the number of screenings received by any individual such that the
reference effective dose equivalent shall not exceed:
10.7.3.5.1. 0.25 [mu]Sv (25 [mu]rem) per
screening; and
10.7.3.5.2. 250
[mu]Sv (25 mrem) over any 12 month period;
10.7.3.6. For limited-use full-body security
screening systems capable of delivering a maximum effective dose equivalent
greater than 0.1 [mu]Sv (10 [mu]rem) per scan: policies and records to show
that administrative controls are applied to limit the number of screenings
received by any individual such that the reference effective dose equivalent
shall not exceed:
10.7.3.6.1. 10 [mu]Sv (1
mrem) per screening; and
10.7.3.6.2. 250 [mu]Sv (25 mrem) over any 12
month period;
10.7.3.7.
For general-use partial-body security screening systems capable of delivering a
maximum effective dose equivalent less than or equal to 0.1 Sv (10 rem) per
scan: policies and records to show that administrative controls will be applied
to limit the number of screenings received by any individual, such that:
10.7.3.7.1. The ADAP shall not exceed 0.03 Sv
per square meter (3 rem per square meter) per scan; and
10.7.3.7.2. The total number of scans
received at the facility in a 12 month period shall not exceed N, where N = 75
Sv per square meter per ADAP (7500 rem per square meter per ADAP);
10.7.3.8. For limited-use
partial-body security screening systems capable of delivering a maximum
effective dose equivalent greater than 0.1 Sv (10 rem) per scan: policies and
records to show that administrative controls will be applied to limit the
number of screenings received by any individual, such that:
10.7.3.8.1. The ADAP shall not exceed 3 Sv
per square meter (300 rem per square meter) per scan; and
10.7.3.8.2. The total number of scans
received at the facility in a 12 month period shall not exceed N, where N = 75
Sv per square meter per ADAP (7500 rem per square meter per ADAP).
10.7.4. Each registrant
operating a security screening system shall meet the following facility,
design, shielding, and restricted area requirements:
10.7.4.1. A clearly marked restricted area
shall be established. The dose outside of the restricted area shall not exceed
20 Sv (2 mrem) in any one hour;
10.7.4.2. A means shall be provided for the
operator responsible for initiating the scan to maintain a full visual
surveillance of the screening and restricted area; and
10.7.4.3. Engineering or administrative
controls shall be provided to ensure that individuals do not reenter the
scanning area from the exit while x-rays are being produced.
10.7.5. Screening systems capable
of delivering an effective dose equivalent greater than 10 [mu]Sv (1 mrem) per
scan shall not be used for non-medical screening of humans for security
purposes.
10.8.
Measurements, Monitoring, and Surveys
10.8.1.
Radiation Levels
10.8.1.1. X-ray equipment
shall be located and arranged with sufficient shielding and area access control
to ensure compliance with Section
7.0.
10.8.1.2. The registrant shall ensure that no
radiation levels exist in any area surrounding the local component group which
could result in a dose to an individual present therein in excess of the dose
limits in Section
7.6.
10.8.2. The registrant shall document
performance of radiation surveys, as required by Section
7.7, sufficient to show compliance with
Section 10.8.1:
10.8.2.1. Upon installation of the equipment,
and at least once every 12 months thereafter;
10.8.2.2. Following any change in the initial
arrangement, number, or type of local components in the system;
10.8.2.3. Following any maintenance requiring
the disassembly or removal of a local component in the system;
10.8.2.4. During the performance of
maintenance and alignment procedures if the procedures require the presence of
a primary x-ray beam when any local component in the system is disassembled or
removed;
10.8.2.5. Any time a
visual inspection of the local components in the system reveals an abnormal
condition; and
10.8.2.6. Whenever
personnel monitoring devices show a significant increase over the previous
monitoring period or the readings are approaching the limits specified in
Section 7.2.
10.8.3. Radiation survey measurements shall
not be required if a registrant can demonstrate, to the satisfaction of the
Department, that the local components of an analytical x-ray system shall be
located and arranged and include sufficient shielding or access control such
that no radiation levels exist in any area surrounding the local component
group which result in a dose to an individual present therein in excess of the
dose limits given in Section
7.0.
10.8.4. Personnel Monitoring Requirements
10.8.4.1. Each individual who is associated
with the operation of a non-healing-arts radiation generating machine shall
meet the requirements of Sections
7.2 through
7.6.
10.8.4.1.1. Each operator of portable
handheld x-ray equipment shall wear whole-body and extremity personnel
dosimetric monitoring devices.
10.8.4.1.2. Deliberate exposure of a
personnel dosimetric monitoring device to deceptively indicate a dose delivered
to an individual is strictly prohibited.
10.8.4.2. Finger or wrist dosimetric devices
shall be provided to and shall be used by:
10.8.4.2.1. Analytical x-ray equipment
operators using systems having an open-beam configuration if and when a safety
device is not present, is not in use, or is disabled; and
10.8.4.2.2. Personnel maintaining analytical
x-ray equipment if the maintenance procedures require the presence of a primary
x-ray beam when any local component in the analytical x-ray system is
disassembled or removed.
10.8.4.3. Reported dose values shall not be
used for the purpose of determining compliance with Section
7.2 unless evaluated by a Qualified
Expert.
10.9.
Quality Assurance Requirements
10.9.1. Each
non-healing-arts radiation generating machine shall have written quality
control and quality assurance procedures that follow:
10.9.1.1. Recommendations of the
manufacturer;
10.9.1.2.
Recommendations of the Radiation Safety Officer; and/or
10.9.1.3. Standards of an appropriate
nationally recognized organization.
10.9.2. Records that demonstrate compliance
with Section
10.5 and Section
10.7 shall be maintained by the registrant
for 10 years for inspection by the Department. In addition to complying with
the requirements of Section
10.5 and Section
10.7, records of individual monitoring
results shall be maintained by the registrant in accordance with Section
7.12.
11.0 Radiation Safety Requirements for
Industrial Radiographic Machines.
11.1.
Purpose and Scope
11.1.1. This Section
establishes requirements, for which the registrant is responsible, for use of
industrial radiographic machines not otherwise covered by this Rule, except
those which contain radioactive materials, which are addressed in Part B of
this Rule. The provisions of this Section are in addition to, and not in
substitution for, other applicable provisions of this Rule.
11.1.2. The registrant shall be responsible
for directing the operation of the radiation generating machines which have
been registered with the Department. The registrant shall ensure that the
requirements of this Section are met in the operation of the industrial
radiographic machine(s).
11.1.3.
This Section applies to all registrants who use radiation generating machines
for industrial radiography.
11.2. Exemptions
11.2.1. Uses of certified and certifiable
(per FDA 21 CFR
1020.40(d)) cabinet x-ray
systems are exempt from the requirements of Section
11.0 except for the following:
11.2.1.1. For certified and certifiable
cabinet x-ray systems, including those designed to allow admittance of
individuals:
11.2.1.1.1. No registrant shall
permit any individual to operate a cabinet x-ray system until the individual
has received a copy of and instruction in the operating procedures for the unit
and has demonstrated competence in its use.
11.2.1.1.1.1. Records that demonstrate
compliance with Section
11.2.1.1.1 shall be maintained for at
least 3 years after the individual stops operation the
unit.
11.2.1.1.2. Tests
for proper operation of interlocks must be conducted and recorded by the
registrant at intervals not to exceed 6 months.
11.2.1.1.2.1. Records of these tests shall be
maintained for 3 years after the record was made.
11.2.1.1.3. The registrant shall perform an
evaluation of the radiation exposure to determine compliance with Section
7.6.1 and
21 CFR
1020.40 (April 1, 2004) (Cabinet X-Ray
Systems, 39 Federal Register 12986, April 10, 1974), at intervals not to exceed
1 year.
11.2.1.1.3.1. Records of these
evaluations shall be maintained for Department inspection for 3 years after the
evaluation.
11.2.1.2. Certified cabinet x-ray systems
shall be maintained in compliance with
21 CFR
1020.40 (April 1, 2004) (Cabinet X-Ray
Systems, 39 Federal Register 12986, April 10, 1974), and no modification shall
be made to the system unless prior Department approval has been
granted.
11.2.2.
Industrial uses of handheld light intensified imaging devices are exempt from
the requirements of this Part if the dose rate 45 centimeters (18 inches) from
the source of radiation to any individual does not exceed 0.02 mSv (2 mrem) per
hour. When this dose rate is exceeded, such devices shall meet the applicable
requirements of this Rule and the registration requirements of Section
5.0.
11.3. Training of Radiographer and
Radiographer's Assistant
11.3.1. The
registrant shall not permit any individual to act as a radiographer unless and
until the individual has provided evidence of having:
11.3.1.1. Satisfactorily completed 40 hours
of training, including each of the following:
11.3.1.1.1. Fundamentals of radiation safety,
including:
11.3.1.1.1.1. Characteristics of
x-radiation;
11.3.1.1.1.2. Units of
radiation dose;
11.3.1.1.1.3.
Hazards of exposure to radiation;
11.3.1.1.1.4. Levels of radiation from
sources of radiation;
11.3.1.1.1.5.
Methods of controlling radiation dose (time, distance, and
shielding);
11.3.1.1.2.
Radiation detection instruments including:
11.3.1.1.2.1. Use, operation, calibration,
and limitations of radiation survey instruments;
11.3.1.1.2.2. Survey techniques;
11.3.1.1.2.3. Use of personnel monitoring
equipment;
11.3.1.1.3.
Equipment to be used including:
11.3.1.1.3.1.
Operation and control of radiation machines;
11.3.1.1.3.2. Storage, control, and disposal
of sources of radiation;
11.3.1.1.3.3. Inspection and maintenance of
equipment;
11.3.1.1.4.
The requirements of this Rule.
11.3.1.2. Completed hands-on and on-the-job
training in the performance of industrial radiography. The on-the-job training
shall include a minimum of 160 hours (1 month) of on-the-job active
participation utilizing radioactive machines.
11.3.1.2.1. The hours of on-the-job training
do not include safety meetings, classroom training, travel, darkroom
activities, film development and interpretation, or use of a cabinet x-ray
unit.
11.3.2.
The registrant shall not permit any individual to act as a radiographer's
assistant unless and until the individual has received initial radiation safety
training.
11.3.2.1. The radiographer's
assistant shall be under the direct supervision of a radiographer whenever a
radiographer assistant:
11.3.2.1.1. Uses
radiation machines or associated equipment; or
11.3.2.1.2. Performs radiation surveys to
determine that the radiation machine has stopped producing radiation.
11.3.3. Radiographers
and radiographer's assistants shall receive annual refresher radiation safety
training at intervals not to exceed 12 months.
11.4. Locking of Industrial Radiographic
Machines
11.4.1. The control panel of each
radiation machine shall be equipped with a lock that will prevent the
unauthorized use of an x-ray system or the accidental production of
radiation.
11.4.2. The radiation
machine shall be kept locked and the key removed at all times except when under
the direct visual surveillance of a radiographer or a radiographer's
assistant.
11.5.
Inspection and Maintenance
11.5.1. The
registrant shall perform visual and operability checks on radiation machines
and associated equipment before each day's use, or work shift, to ensure that
the equipment is in good working condition.
11.5.2. If equipment problems are found, the
equipment must be removed from service until repaired.
11.5.3. Each registrant shall have written
procedures for, and perform inspection and routine maintenance of, radiation
machines and associated equipment. The inspection and maintenance must be
performed at intervals not to exceed 3 months, or before the first use
thereafter, to ensure the proper functioning of components important to safety.
If equipment problems are found, the equipment must be removed from service
until repaired.
11.5.4. Each
registrant shall maintain records of equipment problems found in daily checks
and quarterly inspections of radiation machines and associated equipment and
retain each record for 3 years after it is made.
11.5.4.1. The record must include the date of
check or inspection, name of inspector, equipment involved, any problems found,
and what repair and/or maintenance, if any, was performed.
11.6. Operating and Emergency
Procedures
11.6.1. Operating and emergency
procedures must include, as a minimum, instructions in the following:
11.6.1.1. Appropriate handling and use of
radiation machines so that no person is likely to be exposed to radiation doses
in excess of the limits established in Section
7.0;
11.6.1.2. Methods for posting and controlling
access to radiographic areas;
11.6.1.3. Methods and occasions for locking
and securing radiation machines;
11.6.1.4. Personnel monitoring and use of
personnel monitoring equipment;
11.6.1.5. Transporting equipment to field
locations, including packing of radiation machines;
11.6.1.6. The inspection, maintenance, and
operability checks of radiation machines and associated equipment;
11.6.1.7. The procedure for notifying proper
persons in the event of an accident or incident; and
11.6.1.8. Maintenance of records.
11.6.2. The registrant shall
maintain copies of current operating and emergency procedures for the duration
of registration.
11.6.2.1. Superseded
material must be retained for 3 years after the change is made.
11.7. Utilization Logs
11.7.1. Each registrant shall maintain
utilization logs showing for each radiation machine the following information:
11.7.1.1. A description, including the make,
model, and serial number of the radiation machine;
11.7.1.2. The identity and signature of the
radiographer to whom assigned;
11.7.1.3. The location and dates of use,
including the dates removed and returned to storage; and
11.7.1.4. For permanent radiographic
installations, the dates each radiation machine is energized.
11.7.2. The registrant shall
retain the logs required by Section
11.7.1 for 3 years.
11.7.3. The registrant shall maintain
adequate safeguards against tampering with and loss of records.
12.0 Radiation Safety
Requirements for Particle Accelerators Not Used in the Healing Arts.
12.1. Purpose and Scope
12.1.1. This Section establishes
requirements, for which the registrant is responsible, for use of particle
accelerators not used in the healing arts and not otherwise covered by this
Rule. The provisions of this Section are in addition to, and not in
substitution for, other applicable provisions of this Rule.
12.1.2. The registrant shall be responsible
for directing the operation of the radiation generating machines which have
been registered with the Department. The registrant shall ensure that the
requirements of this Section are met in the operation of particle accelerators
not used in the healing arts.
12.2. General Requirements for the Issuance
of a Registration for Particle Accelerators Not Used in the Healing Arts
12.2.1. In addition to the requirement of
Section 5.0, a registration
application for use of a particle accelerator will be approved only if the
Department determines that:
12.2.1.1. The
applicant is qualified by reason of training and experience to use the
accelerator in question for the purpose requested in accordance with this
Section and Section
5.0 in such a manner as to minimize danger
to public health and safety or property;
12.2.1.2. The applicant's proposed equipment,
facilities, operating and emergency procedures are adequate to protect health
and minimize danger to public health and safety or property;
12.2.1.3. The issuance of the registration
will not be inimical to the health and safety of the public;
12.2.1.4. The applicant has appointed a
Radiation Safety Officer;
12.2.1.5.
The applicant and/or their staff has substantial experience in the use of
particle accelerators for the intended uses; and
12.2.1.6. The applicant has an adequate
training program for particle accelerator operators.
12.3. Radiation Safety
Requirements for the Use of Particle Accelerators Not Used in the Healing Arts
12.3.1. A registrant shall use the
accelerator in accordance with the manufacturer's radiation safety and
operating instructions.
12.3.2.
Limitations
12.3.2.1. No registrant shall
permit any person to act as a particle accelerator operator until such person:
12.3.2.1.1. Has been instructed in radiation
safety and shall have demonstrated an understanding thereof to the satisfaction
of the Radiation Safety Officer;
12.3.2.1.2. Has received copies of, and
instructions required by, this Section and the applicable requirements of
Sections 5.0 and
7.0, pertinent registration conditions and
the registrant's operating and emergency procedures, and has demonstrated
understanding thereof; and
12.3.2.1.3. Has demonstrated competence to
use the particle accelerator, related equipment, and survey instruments which
will be employed in their assignment to the satisfaction of the Radiation
Safety Officer.
12.3.2.2.
The Radiation Safety Officer shall have the authority to terminate the
operations at a particle accelerator facility if such action is deemed
necessary to minimize danger to public health and safety or
property.
12.3.3.
Shielding and Safety Design Requirements
12.3.3.1. A Qualified Expert, registered with
the Department, shall be consulted in the design of a particle accelerator
installation and called upon to perform a radiation survey when the accelerator
is first capable of producing radiation.
12.3.3.2. Each particle accelerator
installation shall be provided with such primary and/or secondary barriers as
are necessary to ensure compliance with Sections
7.2 and
7.6.
12.3.4. Particle Accelerator Controls and
Interlock System
12.3.4.1. Instrumentation,
readouts and controls on the particle accelerator control console shall be
clearly identified and easily discernible.
12.3.4.2. 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.
12.3.4.3. When a safety interlock system has
been tripped, it shall only be possible to resume operation of the accelerator
by manually resetting controls at the position where the safety interlock has
been tripped, and lastly at the main control console.
12.3.4.4. Each safety interlock shall be on a
circuit which shall allow its operation independently of all other safety
interlocks.
12.3.4.5. All safety
interlocks shall be designed so that any defect or component failure in the
safety interlock system prevents operation of the accelerator.
12.3.4.6. A scram button or other emergency
power cutoff switch shall be located and easily identifiable in all high
radiation areas. Such a cutoff switch shall include a manual reset so that the
accelerator cannot be restarted from the accelerator control console without
resetting the cutoff switch.
12.3.5. Warning Devices
12.3.5.1. Each location designated as high
radiation area, and each entrance to such location, shall be equipped with
easily observable warning lights that operate when, and only when, radiation is
being produced.
12.3.5.2. Except in
facilities designed for human exposure, each high radiation area shall have an
audible warning device which shall be activated for 15 seconds prior to the
possible creation of such high radiation area. Such warning device shall be
clearly discernible in all high radiation areas.
12.3.5.3. Barriers, temporary or otherwise,
and pathways leading to high radiation areas shall be posted with a conspicuous
sign or signs bearing the radiation symbol and the words "CAUTION, HIGH
RADIATION AREA," or "DANGER, HIGH RADIATION AREA."
12.3.6. Operating Procedures
12.3.6.1. Each particle accelerator, when not
in operation, shall be secured to prevent unauthorized use.
12.3.6.2. Only a switch on the accelerator
control console shall be routinely used to turn the accelerator beam on and
off. The safety interlock system shall not be used to turn off the accelerator
beam except in an emergency.
12.3.6.3. Safety Checks
12.3.6.3.1. All safety and warning devices,
including interlocks, shall be checked for proper operability at intervals not
to exceed 3 months. Safety checks shall ensure, as appropriate, proper
operation of:
12.3.6.3.1.1. Electrical
interlocks at each room entrance;
12.3.6.3.1.2. Timer, dose terminator,
emergency off, and door interlocks;
12.3.6.3.1.3. Beam condition indicator lights
on the accelerator unit, on the control panel, and in the facility;
12.3.6.3.1.4. Viewing systems;
12.3.6.3.1.5. Doors from inside and outside
the accelerator room; and
12.3.6.3.1.6. Electrically assisted room
doors with the accelerator unit electrical power turned off.
12.3.6.3.2. A registrant shall
promptly repair any system identified in Section
12.3.6.3.1 that is not operating
properly. The accelerator shall not be used until all repairs are completed,
except as may be necessary to repair, replace, or check the malfunctioning
system.
12.3.6.3.3. A registrant
shall maintain a record of the results of each safety check required by Section
12.3.6.3.1 for 3 years at the
accelerator facility for inspection by the Department. The record shall
include:
12.3.6.3.3.1. The date of the safety
check;
12.3.6.3.3.2. The
manufacturer's name, model number, and serial number for the
accelerator;
12.3.6.3.3.3. The
manufacturer's name, model number, serial number, and calibration date of the
instrument used to conduct any measurements.
12.3.6.3.3.4. Notations indicating the
operability of each entrance door interlock, each electrical or mechanical
stop, each beam condition indicator light, the viewing system, and doors;
and
12.3.6.3.3.5. The signature of
the individual who performed the periodic routine QCs.
12.3.6.4. Electrical circuit
diagrams of the accelerator, and the associated interlock systems, shall be
kept current and maintained for inspection by the Department and available to
the operator at each accelerator facility.
12.3.6.5. If it is necessary to intentionally
bypass a safety interlock or interlocks, such action shall be:
12.3.6.5.1. Authorized by the Radiation
Safety Officer;
12.3.6.5.2. Recorded
in a permanent log and a notice posted at the accelerator control console;
and
12.3.6.5.3. Terminated as soon
as possible.
12.3.6.6.
Current operating and emergency procedures shall be developed. These
instructions shall be maintained at the accelerator control panel and shall
inform the operator of:
12.3.6.6.1. The
procedure to be followed if the operator is unable to turn the accelerator off
with controls at the control panel or any other abnormal operation occurs;
and
12.3.6.6.2. The names and
telephone numbers of the Radiation Safety Officer to be immediately contacted
if the accelerator or console operates abnormally.
12.3.6.7. A registrant shall provide
instruction in the topics identified in Section
12.3.6.6 to each individual who
operates an accelerator and shall provide appropriate refresher training to
each individual operator at intervals not to exceed 1 year.
12.3.6.8. A registrant shall maintain a
record of each individual receiving instructions required by Section
12.3.6.7, a description of the
instruction, the date of instruction, and the name of the individual who gave
the instruction for 3 years.
12.3.7. Radiation Monitoring Requirements
12.3.7.1. There shall be available at each
particle accelerator facility, appropriate portable monitoring equipment which
is operable and has been calibrated for the appropriate radiations being
produced at the facility.
12.3.7.1.1. Such
equipment shall be tested for proper functioning prior to each day of
accelerator operation and calibrated at intervals not to exceed 12 months and
after each servicing and repair.
12.3.7.2. A radiation protection survey shall
be performed and documented by a Qualified Expert when changes have been made
in shielding, operation, equipment, or occupancy of adjacent areas.
12.3.7.2.1. A registrant shall maintain a
record of the radiation measurements made following installation of the
accelerator for the duration of the registration and when subsequent changes
occur that could potentially affect the radiation levels in adjacent areas. The
record shall include:
12.3.7.2.1.1. The date
of the measurements;
12.3.7.2.1.2.
The manufacturer's name, model number, and serial number of the
accelerator;
12.3.7.2.1.3. A
description of the accelerator configuration including whether there were any
test objects in the accelerator beam;
12.3.7.2.1.4. The instrument used to measure
radiation levels;
12.3.7.2.1.5. A
plan of the areas surrounding the accelerator that were surveyed;
12.3.7.2.1.6. The measured dose rate at
several points in each area expressed in microsievert (millirem) per
hour;
12.3.7.2.1.7. The calculated
maximum level of radiation over a period of 1 week for each restricted and
unrestricted area; and
12.3.7.2.1.8. The signature of the Radiation
Safety Officer.
12.3.7.3. Radiation levels in all high
radiation areas shall be continuously monitored. The monitoring devices shall
be electrically independent of the accelerator control and safety interlock
systems and capable of providing a readout at the control panel.
12.3.7.4. All area monitors shall be
calibrated at intervals not to exceed 3 months.
12.3.7.5. Whenever applicable, periodic
surveys shall be made to determine the amount of airborne particulate
radioactivity present in areas of airborne hazards.
12.3.7.6. Whenever applicable, periodic smear
surveys shall be made to determine the degree of contamination in target and
other pertinent areas.
12.3.7.7.
All area surveys shall be made in accordance with the written procedures
established by a Qualified Expert.
12.3.7.8. Records of all radiation protection
surveys, calibration results, instrumentation tests, and smear results shall be
maintained for 3 years at the accelerator facility for inspection by the
Department.
12.3.8.
Ventilation Systems
12.3.8.1. Ventilation
systems shall be provided to ensure that personnel entering any area where
airborne radioactivity may be produced will not be exposed to airborne
radioactive material in excess of those limits specified in 10 CFR Part 20,
Appendix B, Table 1.
12.3.8.2. A
registrant shall not vent, release or otherwise discharge airborne radioactive
material to an unrestricted area which exceed the limits specified in 10 CFR
Part 20, Appendix B, Table 1.
12.3.8.3. For purposes of Section
12.3.8.1 and Section
12.3.8.2, concentrations may be
averaged over a period not greater than 12 months.
12.3.8.4. Every effort should be made to
maintain releases of radioactive material to unrestricted areas as far below
the limits prescribed in Section
12.3.8.1 and Section
12.3.8.2 as is reasonably
achievable.
13.0 Record Keeping Requirements.
13.1. Each record required by this Rule must
be legible throughout the specified retention period. The record may be the
original or a reproduced copy provided that the copy is authenticated by
authorized personnel.
13.2. Records
may also be stored in electronic media with the capability for producing
legible, accurate, and complete records during the required retention
period.
13.3. Records such as
letters, drawings, and specifications must include all pertinent information,
such as stamps, initials, and signatures.
14.0 Notice, Corrective Actions, and
Enforcement.
14.1. If an inspection indicates
that the regulated entity is not in compliance with the requirements of this
Rule, the Department may issue a notice of non-compliance to the regulated
entity, detailing any deficiencies.
14.1.1.
The notice shall include specific required corrective actions necessary for the
regulated entity to take to regain compliance with this Rule, and may include
interim corrective actions, such as requiring further investigation of the
circumstances giving rise to the notice, or ceasing use of the source of
radiation until such time as full compliance is restored, or such other action
deemed necessary by the Department to protect the public health and safety is
completed.
14.1.2. A regulated
entity shall respond to the Department within the time specified in the notice,
which shall be determined by the risk associated with the alleged
non-compliance.
14.2. If
the Department determines that an enforcement action is appropriate, or if
timely and satisfactory compliance with a notice issued pursuant to Section
14.0 has not been achieved, the Department
may issue a notice of violation to the regulated entity. The notice shall
specify the nature of the violation and required action to restore full
compliance.
14.3. An appeal of any
order issued by the Board pursuant to this Section shall be to the Civil
Division of the Superior Court as provided in 18 V.S.A. §1655(c).
PART B: RADIOACTIVE MATERIALS
SECTION I. OVERVIEW
1.0 General Provisions.
1.1 Purpose.
Part B of this Rule establishes requirements for the protection of public health and safety as related to radioactive materials and implements the requirements of 18 V.S.A. §§1652 and 1653.
1.2 Scope.
1.2.1 This regulation, except as otherwise
specifically provided, applies to persons who use, manufacture, produce,
transport, transfer, receive, acquire, possess, own or dispose of radioactive
materials.
1.2.2 A person, when
required, shall obtain a license for radioactive materials in the possession or
control of the person, and shall comply with the statute and this
regulation.
1.2.3 As established in
18 V.S.A. §1653 (c) this Rule does
not regulate materials or activities reserved to the Nuclear Regulatory
Commission (NRC) under 42
U.S.C. §
2021(c) and 10
C.F.R. Part 150.
1.2.4
Notwithstanding the requirements incorporated by reference, nothing in this
Rule relieves or limits a person from complying with the laws of the State of
Vermont, including Vermont Statutes Title 18: Chapter 32, Title 10: Chapter
161, Title 10: Chapter 162 and Title 18: Chapter 31.
1.2.5 Title 10 Chapter I (Nuclear Regulatory
Commission) Parts 19, 20, 30, 31, 32, 33, 34, 35, 36, 37, 39, 40, 61.55, 61.56,
61.57, 70, 71, 150.1, 150.2, 150.3, 150.11, 150.20, 170, and 171 of the C.F.R.
are incorporated by reference with the exceptions set forth in the relevant
subsections, which either do not apply or are under the authority of the NRC.
The unofficial version of these parts may be accessed at:
http://www.nrc.gov/. An official
version is also available by hard copy.
1.2.6 To reconcile differences between this
regulation and the incorporated sections of Federal regulations and to
effectuate their joint enforcement, the following words and phrases shall be
substituted for the language of the Federal regulations:
1.2.6.1 With the exception of
10 CFR
30.4 and in the definition of Special Nuclear
Material in 10 CFR
20.1003 which are incorporated by reference,
a reference to ''NRC'' or ''Commission'' means the Vermont Department of
Health.
1.2.6.2 A reference to
''NRC or agreement state'' means the Vermont Department of Health, NRC, or
agreement state.
1.2.6.3 A
reference to "the Act" means a reference to Vermont statute 18 V.S.A. §1651-1658.
1.2.6.4 A reference to ''byproduct material''
includes naturally occurring or accelerator-produced radioactive material
(NARM).
1.2.6.5 In
10 CFR
40.4 the terms "Foreign Obligations" and
Reconciliation" are not incorporated. In
10 CFR
40.4, in the definition of "Special Nuclear
Material", the sentence "and any other material which the Commission, pursuant
to the provisions of section
51 of the Act, determines to be special
nuclear material", remains preserved.
1.2.6.6 With the exception of criminal
history records required by 10 C.F.R. 37.27 (relating to
requirements for criminal history checks of individuals granted unescorted
access to category 1 or category 2 quantities of radioactive material),
notifications, reports and correspondence referenced in the incorporated parts
of 10 C.F.R. shall be directed to the Vermont Department of Health after
agreement state status is in effect, and, for NRC licenses, to the NRC until
agreement state status is in effect. Criminal history records required by
10 C.F.R.
37.27 are to be sent to the NRC.
Communications and reports concerning these regulations and applications filed
under it shall be addressed to the Radiological amp; Toxicological Sciences
Program, Vermont Department of Health, 108 Cherry Street, Burlington, Vermont,
05401.
1.2.6.7 Instructions in 10
C.F.R. to use forms of the NRC means to use forms of the Department, which will
be available on the Department website at http://healthvermont.gov
1.2.6.8 In
10 C.F.R.
30.18(d),
30.32(g),
31.5(b)(1)(ii),
31.5(c)(3)(ii),
31.5(c)(8)(i),
31.6,
31.7(a),
31.10(a),
31.10(b)(1),
31.12(c)(4),
32.13,
32.51(a),
32.51(c),
32.56,
32.59,
32.72(b)(5)(ii),
40.13(c)(10),
40.22(e),
40.25(b),
40.25(d)(3),
40.54,
40.55(c),
(c)(1), (d)(1)(ii), (d)(2) and (d)(3), where
a reference is made to "an Agreement State", it means "an Agreement State or
the NRC".
1.2.6.9 In
10 C.F.R.
70.19(a) (1) and
70.19(c)(3), the
terms "Commission or the Atomic Energy Commission" remains and does not mean
the "Department". In 10 CFR
70.42(b)(1) the word
"Department" means the "US Department of Energy".
1.2.6.10 In
10 CFR
150.20, where the words "non-agreement
states", "areas of exclusive federal jurisdiction within agreement states", or
"offshore waters" are used in 150.20(a)(1)(i), (ii), (iii), (b), (b)(3), and
(b)(4) substitute the words "the State of Vermont". Where the words "agreement
state license" are used in 10 CFR 150.20, also add the words
"Nuclear Regulatory Commission license". Where the words "license issued by an
agreement state" are used in 10 CFR 150.20 also add the words
"license issued by the Nuclear Regulatory Commission". Where the words "license
from an agreement state" are used in
10 CFR
150.20 also add the words "license from the
Nuclear Regulatory Commission".
1.2.6.11 In
10 CFR
31, where the words "any non-agreement state"
or "offshore waters" are used in 31.6 substitute the words "State of
Vermont".
1.2.7 This Part
does not regulate x-ray and other radiographic diagnostic or therapeutic
equipment use by physicians, dentists, and other health professionals,
occupational sources of radiation from machines and the radiation exposure
values at the site boundary of the Vermont Yankee Nuclear Power
Station.
1.3 Definitions
The definitions in 10 C.F.R. Chapter I, Parts 19, 20, 30, 31, 32, 33, 34, 35, 36, 37, 39, 40, 61, 70, 71,150, 170 and 171 are incorporated by reference in this Rule unless indicated otherwise.
1.3.1 "Agreement State" means any State with
which the Atomic Energy Commission or the Nuclear Regulatory Commission has
entered into an effective agreement under subsection
274 b. of the Atomic Energy Act of 1954, as
amended.
1.3.2 "Department" means
the Vermont Department of Health unless the provision of the Rule states that
the term references the Department of Energy as referenced in
10 C.F.R.
70.42(b)(1).
1.3.3 "Disposal" means the isolation of
radioactive wastes from the biosphere inhabited by man and containing their
food chains by emplacement in a land disposal facility.
1.3.4 "Hazardous waste" means those wastes
designated as hazardous by Environmental Protection Agency regulations in 40
CFR Part 261.
1.3.5 "Licensed
practitioner of the healing arts" means an individual licensed by the State of
Vermont pursuant to Title 26 to practice the healing arts, which for the
purposes of this Rule shall be limited to medicine, surgery, dentistry,
osteopathy, podiatry and chiropractic.
1.3.6 "NARM" means a naturally occurring or
accelerator-produced radioactive material. The term does not include
by-product, source or special nuclear material.
1.3.7 "Radioactive material" means any
material, whether solid, liquid, or gas, that emits ionizing radiation
spontaneously. The term includes material made radioactive by a particle
accelerator, byproduct material, naturally occurring radioactive material,
source material, and special nuclear material.
1.3.8 "Regulated entity" means any
individual, person, organization or corporation that is subject to the
regulatory jurisdiction of the Department within the scope of this
Rule.
1.3.9 "Source material"
means:
(1) uranium or thorium, or any
combination thereof, in any physical or chemical form or
(2) ores which contain by weight
one-twentieth of one percent (0.05%) or more of:
(i) uranium,
(ii) thorium or
(iii) any combination thereof. Source
materials does not include special nuclear material.
1.3.10 "Special nuclear material"
means:
(1) plutonium, uranium 233, uranium
enriched in the isotope 233 or in the isotope 235, and any other material which
the Commission, pursuant to the provisions of section
51 of the Act, determines to be special
nuclear material, but does not include source material; or
(2) any material artificially enriched by any
of the foregoing, but does not include source material.
1.3.11 "Traceable to a National Standard"
means a system which has been calibrated by the National Institute of Science
and Technology or by a Regional Calibration Laboratory accredited by the
American Association of Physicists in Medicine.
1.3.12 Unrefined and unprocessed ore" means
ore in its natural form prior to any processing, such as grinding, roasting or
beneficiating, or refining.
1.3.13
"Waste" means those low-level radioactive wastes containing source, special
nuclear, or byproduct material that are acceptable for disposal in a land
disposal facility. For the purposes of this definition, low-level radioactive
waste means radioactive waste not classified as high-level radioactive waste,
transuranic waste, spent nuclear fuel, or byproduct material as defined in
paragraphs (2), (3), and (4) of the definition of Byproduct material set forth
in 10 CFR §
20.1003.
1.3.14 The definition of regulated entities
in 10 CFR
19.3 is not incorporated by
reference.
2.0
Compliance Monitoring.
2.1 Records
2.1.1 Licensees shall maintain records
showing the receipt, transfer and disposal of radioactive material as described
in 10 C.F.R.
30.51, relating to records.
2.1.2 Additional record requirements are
specified elsewhere in these regulations.
2.2 Inspections and investigations
2.2.1 The Department may conduct inspections
and investigations of the facilities and regulated activities of radioactive
material necessary to demonstrate compliance with these regulations.
2.2.2 Maintenance of records. Licensees shall
maintain records under this Rule and have these records available for
inspection by the Department at permanent sites or facilities of use identified
in a license issued under this regulation.
2.2.3 Licensees will permit the Department
to:
2.2.3.1 Have access to, and require the
production of, books, papers, documents and other records and physical evidence
pertinent to a matter under inspection or investigation.
2.2.3.2 Require a licensee to make reports
and furnish information to the Department.
2.2.3.3 Enter the premises of a licensee for
the purpose of investigation or inspection of radioactive materials and the
premises and facilities where radioactive materials are used or stored,
necessary to ascertain the compliance or noncompliance with these regulations
and this subsection and to protect health, safety and the
environment.
2.2.4 The
Department may conduct additional follow-up inspections and investigations if
violations of the regulations promulgated thereunder were noted at the time of
the original inspection, or if a person presents information, or circumstances
arise, which give the Department reason to believe that the health and safety
of a person is threatened or that these regulations are being
violated.
2.3 Tests
2.3.1 Licensees, upon instruction from the
Department, shall perform, or permit the Department to perform, reasonable
tests as the Department deems appropriate or necessary including, but not
limited to, tests of:
2.3.1.1 Radioactive
materials.
2.3.1.2 Facilities in
which radioactive materials are used or stored.
2.3.1.3 Radiation detection and monitoring
instruments.
2.3.1.4 Other
equipment and devices in connection with utilization or storage of licensed
radioactive materials.
2.4 The Department may impose upon a person,
requirements additional to those established in these regulations which it may
deem reasonable and necessary to protect the public health and safety. As an
example, when necessary or desirable to determine the extent of an individual's
exposure to concentrations of radioactive material, the Department may require
a licensee to provide to the individual appropriate bioassay services, medical
services and the services of a Qualified Expert and to furnish a copy of the
reports of these services to the Department.
3.0 Prohibitions, Restrictions and Additional
Requirements.
3.1 Sale of radioactive
materials.
No person may sell within the State of Vermont radioactive materials which do not meet the requirements of these regulations.
3.2 Human use
3.2.1 No use of radioactive materials on
humans may be permitted except under this regulation, and limited to the
following license or certificate holders under Vermont Statutes Annotated,
Title 26 Professions and Occupations: Podiatry (Chapter 7); Chiropractic
(Chapter 10); Dentists, Dental Hygienists, and Dental Assistants (Chapter 12);
Medicine (Chapter 23); Physician Assistants (Chapter 31); Osteopathy (Chapter
33); Radiology (Chapter 51); Radiologist Assistants (Chapter 52).
3.2.2 Auxiliary personnel employed by a
licensed practitioner of the healing arts at the location at which the licensed
practitioner practices may use radioactive materials in the healing arts
provided those individuals comply with the applicable requirements in
3.2.1.
3.2.3 Auxiliary personnel
employed by a health care facility regulated by the Department of Health may
only use radioactive materials in the healing arts in accordance with written
job descriptions and employee qualifications.
3.2.4 Paragraphs 3.2.2 and 3.2.3
notwithstanding, human use of radioactive materials is permitted by individuals
enrolled in clinical training programs that satisfy the related accreditation
requirements of the boards in paragraph 3.2.1 and who are under the supervision
of a licensed practitioner of the healing arts or of auxiliary personnel
authorized under paragraphs 3.2.2 and 3.2.3 to use radioactive materials
sources in the healing arts.
3.3 Deliberate misconduct.
The requirements under 10 C.F.R. 30.10 (relating to deliberate misconduct) are incorporated by reference. In 10 C.F.R. 30.10(b), the reference to 10 C.F.R. 2, relating to deliberate misconduct, is replaced with 18 VSA §1651 - 1657 and Radioactive Material Program Procedure Section 2.5, Enforcement, Escalated Enforcement and Administrative Actions.
3.4
Employee protections.
The requirements under 10 C.F.R. 30.7 (relating to employee protection) are incorporated by reference.
3.5 Vacating premises.
In addition to the decommissioning requirements of 10 C.F.R. 30.36 (relating to expiration and termination of licenses and decommissioning of sites and separate buildings or outdoor areas) that are incorporated by reference under Subsection 11.0 (relating to licensing of radioactive material), a licensee shall notify the Department in writing of intent to vacate at least 30 days before vacating or relinquishing possession or control of premises which may have been contaminated with radioactive material as a result of the licensee's activities. When deemed necessary by the Department, the licensee shall decontaminate the premises as the Department may specify.
3.6 Improper use of
a monitoring device.
The deliberate exposure of, failure to use, or improper use of, an individual monitoring device or area monitoring device by an individual is prohibited.
3.7
Penalties.
A person who violates this Rule is subject to the civil and criminal penalties in 18 V.S.A. §§1651-1657. At a minimum, civil penalties may be assessed in an amount sufficient to recover the costs expended by the Department in the correction of the violation or abatement of the resulting radiological nuisance.
4.0 Exemptions.
4.1 Granting exemptions The Department may,
upon application therefore or upon its own initiative, grant exemptions from
this regulation when the Department makes a finding that the exemption(s) do
not result in significant risk to the health and safety of the public and
safeguards that provide equivalent levels of protection in this Rule are
implemented.
4.2 Exemption
Qualifications.
The following sources, uses and types of users are exempt from this subchapter:
4.2.1 Federal
government agencies
4.2.1
Electrical equipment
4.2.1.1 Equipment that
produces radiation incidental to its operation for other purposes if the dose
equivalent rate averaged over an area of 10 square centimeters does not exceed
0.005 mSv (0.5 mrem) per hour at 5 centimeters from an accessible
surface.
4.2.1.2 The equipment is
not exempt when operated without adequate shielding during testing and
servicing if radiation levels exceed those specified. Electron beam welders and
electron microscopes are not exempt.
4.2.3 A material, product or use specifically
exempted from licensing requirements by the NRC, the Department or an agreement
state or authorized for distribution to persons exempt from license
requirements.
5.0 Fees.
5.1 Scope.
5.1.1 This subsection establishes fees for
licensing of radioactive materials and provides for their payment. The fee
schedule for licensing materials is found at 18 V.S.A. §1653 (b)(3).
5.1.2 For the purpose of this subsection,
radioactive materials under the same administrative control in a single
building are licensed as a single facility. Radioactive materials under the
same administrative control at the same address or in a contiguous group of
buildings may be licensed as a single facility if the Department determines
that it is appropriate.
5.1.3
Except as otherwise specifically provided, this subsection applies to a person
who: Is an applicant for or holder of a radioactive material license issued
under Subsection
11.0 (relating to licensing of radioactive
materials).
5.2
Incorporation by reference.
5.2.1
Notwithstanding the requirements incorporated by reference, Sections
170.2(d),
170.2(e),
170.2(g) through
170.2(p),
170.2(r),
170.2(t),
170.4,
170.5,
170.8,
170.11,
170.12(c)(1),
170.12(c)(3),
170.12(d) through
170.12(f),
170.21,
170.51,
171.8,
171.9,
171.11,
171.13,
171.15,
171.16(a)(1)(v),
171.17(a),
171.19,
171.23 and
171.25 are not incorporated by
reference.
5.3
Radioactive Materials fees.
5.3.1 Annual
license fees for radioactive material are set forth in
10 C.F.R.
171. Other radioactive materials fees are
described in 10 C.F.R.
170.
5.3.1.1
No refund will be made for termination of a license.
5.3.1.2 If, by amendment or otherwise, a
license changes to another fee category, the fee for the new category will take
effect on the anniversary date of the license.
5.3.2 An initial application for a license or
reciprocity shall be accompanied by a check payable to the Department in
accordance with the fee schedules in
10 C.F.R.
170 and
171. Thereafter, the Department
will issue an annual fee invoice in accordance with the appropriate fee
schedule at least 2 months prior to the license expiration. Fees are payable by
the last day of the license expiration month as shown on the license fee
invoice. This provision is not applicable to full cost recovery
licenses.
5.3.3 The Department will
not accept an initial application for a license prior to payment of the fees
required by paragraphs 5.3.1 and 5.3.2.
5.3.4 If a license involves more than one of
the categories in paragraph 5.3.2, the highest applicable fee
applies.
5.3.5 Special provisions
for calculating annual fees during agreement state transition period.
5.3.5.1 The annual fees for the NRC licenses
that are transferred to the State of Vermont on the date the State of Vermont
becomes an agreement state will be invoiced on the license's next anniversary
date.
5.3.5.2 During the first year
after the date the Department attains agreement state status, the annual fee
for each NRC license transferred to the State of Vermont will include a
proportional amount, based on the schedule of fees in
10 C.F.R.
171, for the period from the date agreement
state status is attained until the license's next anniversary date, in addition
to the amount assessed for the year following the license's anniversary
date.
6.0 Standards for Protection Against
Radiation.
6.1 Purpose and scope
6.1.1 This subsection establishes standards
for protection against ionizing radiation resulting from activities conducted
under licenses issued by the Department. Licensees shall comply with this
subsection.
6.1.2 The requirements
of this subsection are designed to control the receipt, possession, use,
transfer and disposal of radioactive materials by a licensee so the total dose
to an individual, including doses resulting from all sources of radiation other
than background radiation, does not exceed the standards for protection against
radiation prescribed in this subsection. This subsection does not limit actions
that may be necessary to protect health and safety in an emergency. In the
event of an emergency, the Department will provide temporary guidance for dose
management and other health protections.
6.1.3 Except as specifically provided in
other subsections of this Rule, this subsection applies to persons licensed by
the Department to receive, possess, use, transfer or dispose of radioactive
materials.
6.1.4 The limits in this
subsection do not apply to doses due to background radiation, to exposure of
patients to radiation for the purpose of medical diagnosis or therapy, to
exposure from individuals administered radioactive material in accordance with
Subsection
14.0 (related to medical use of byproduct
material) or to voluntary participation in medical research
programs.
6.2
Incorporation by reference
6.2.1 Except as
provided in this subsection, the requirements of 10 C.F.R. Part 20 (relating to
standards for protection against radiation) are incorporated by reference. An
unofficial version can be accessed at http://www.nrc.gov. The official version is
also available in hard copy.
6.2.2
Notwithstanding the requirements incorporated by reference, Sections
20.1006; 20.1009; 20.1405(b);
20.1406(b); 20.1905 (g); 20.2203(c); 20.2206(a)(1), (3), (4) and (5); 20.2401
and 20.2402 are not incorporated.
6.2.3 Effect of incorporation of
10 C.F.R.
20.1403 ''Criteria for license termination
under restricted conditions.''
The Department will not terminate a license under the conditions of restricted release as provided for in 10 C.F.R. 20.1403 (relating to criteria for license termination under restricted conditions) until a license termination plan (LTP), approved by the Department, has been in effect for a period of time demonstrating to the Department that continued implementation of the plan will be effective in maintaining compliance with the required conditions of the plan. The Department may choose to implement the license termination process in one or more of the following steps:
6.2.3.1 The license is amended to authorize
activities necessary to begin decommissioning under the LTP.
6.2.3.2 After decommissioning activities are
complete and the provisions of
10 C.F.R.
20.1403 are in effect under the LTP, the
license may be amended to end authorization of licensed activities. The license
shall remain in effect for up to 5 years being limited to ownership/possession
of the decommissioned material.
6.2.3.3 At the end of the period prescribed
in paragraph 6.2.3.2, the Department will make a determination of the
effectiveness of the established LTP. If the LTP has demonstrated the ability
to maintain compliance with 10 C.F.R. 20.1403, the license
will be terminated subject to the revisitation provision of
10 C.F.R.
20.1401(c) (relating to
general provision and scope) regarding new evidence of a significant threat to
health and safety. Otherwise, the licensee will be directed by the Department
to take corrective actions as necessary to conform to
10 C.F.R.
20.1403 and the process shall revert back to
paragraph 6.2.3.2.
6.2.4
Reports of leaking or contaminated sealed sources. If the test for leakage or
contamination indicates a sealed source is leaking or contaminated, a report of
the test shall be filed within 5 days with the Department describing the
equipment involved, the test results and the corrective action
taken.
7.0
Notices, Instructions and Reports to Workers; Inspections and Investigations.
7.1 Purpose and scope.
7.1.1 This subsection establishes
requirements for notices, instructions and reports by licensees to individuals
engaged in activities under a license. This subsection also establishes options
available to the individuals in connection with Department inspections of
licensees to ascertain compliance with the provisions of the Vermont State
Statutes and regulations, orders and licenses issued thereunder regarding
radiological working conditions.
7.1.2 This subsection applies to persons who
receive, possess, use, own or transfer radioactive materials licensed by the
Department under Subsection
11.0 (relating to licensing of radioactive
material, services and associated healthcare professionals).
7.2 Incorporation by reference.
7.2.1 Except as provided in this subsection,
the requirements of 10 C.F.R. Part 19 (relating to notices, instructions and
reports to workers; inspections and investigations) are incorporated by
reference.
The unofficial version can be accessed at http://www.nrc.gov/. The official version is also available in hard copy.
7.2.2 Notwithstanding the requirements
incorporated by reference, Sections
19.4; 19.5; 19.8; 19.11(a)(4), (b) and (e);
19.14(a); 19.30 and 19.40 are not incorporated. The definition of "regulated
entities" as stated in 10
CFR 19.3 is not incorporated. In
10 C.F.R.
19.13(a), where it says
"Commission" and "Nuclear Regulatory Commission" this means the
Department.
8.0
Reserved.
9.0 Reserved.
10.0 Enforcement.
10.1 Purpose and Scope
10.1.1 Whenever the Department has reasonable
grounds to believe that there has been a violation of any of the provisions of
this Rule, the Department may take appropriate action as provided in this
subsection or otherwise provided in law at 18 V.S.A. Ch. 32, to protect the
public health and safety.
10.1.2 If
an inspection indicates that the regulated entity is not in compliance with the
requirements of this Rule, the Department shall notify the regulated entity in
writing regarding any deficiencies.
10.1.3 The notice shall include specific
required corrective actions necessary for the regulated entity to take to
regain compliance with this Rule and may include interim corrective actions,
such as requiring further investigation of the circumstances giving rise to the
notice, or ceasing use of radioactive materials until full compliance is
restored, or such other action deemed necessary by the Department to protect
the public health and safety is completed.
10.1.4 If the Department determines that an
enforcement action is appropriate, or if timely and satisfactory compliance
with a notice issued pursuant to paragraph 10.1.2 has not been achieved, the
Department shall issue a notice of violation in writing.
10.2 Denial, Amendment, Suspension,
Revocation or Waiver.
10.2.1 In any proceeding
for granting denying, amending, suspending or revoking a license, determining
compliance with, or granting exemptions from, rules or regulations of the
Department the Department shall hold a public hearing upon the request of any
person whose interest may be affected. Any such person shall become a party to
the proceeding. Proceedings shall be conducted in accordance with 18 V.S.A.
§1655 and
3 V.S.A. §814 (the Administrative Procedures
Act).
10.2.2 Any final order
entered in any proceeding under 10.2.1 may be appealed to the Civil Division of
the Superior Court.
10.3
Emergency Orders.
If the Department finds that an emergency exists that requires immediate action to protect the public health and safety the Department may, without notice or hearing, issue an order requiring such action as is necessary to address the emergency in accordance with 18 V.S.A. §1655 (b). Such orders must include a description of the nature of the emergency. Emergency orders take immediate effect and any person to whom the order is directed shall immediately comply. Any person(s) subject to such an order may make application to the Department for a hearing which shall be held within ten days. A decision shall be issued within ten days of the hearing that will continue, modify, or revoke the emergency order.
10.4
Whenever, in the judgment of the Department, any person has engaged in or is
about to engage in any acts or practices which constitute or will constitute a
violation of this Rule, or its authorizing statute, the Department will refer
the matter to the Attorney General who can seek relief in accordance with 18
V.S.A. §1656.
11.0 Licensing of Radioactive Materials.
11.1 Purpose and scope.
11.1.1 This subsection establishes
requirements for the licensing of radioactive material. A person may not
manufacture, produce, receive, possess, use, transfer, own, dispose or acquire
radioactive material except as authorized in a specific or general license
issued under this subsection or otherwise provided in this
subsection.
11.1.2 A licensee is
also subject to Section I. Overview and other relevant subsections of Section
II Radioactive Material.
11.2 The use of radioactive material in the
State of Vermont under a license issued by the NRC is exempt from the licensing
requirements of this subsection.
12.0 Rules of general applicability to
licensing of radioactive materials.
12.1
Persons possessing a license for source, byproduct or special nuclear material
in quantities not sufficient to form a critical mass on the date Vermont
becomes an Agreement State as published in the Federal Register:
On the date the State of Vermont becomes an agreement state as published in the Federal Register, a person who possesses a general or specific license issued by the NRC for source, byproduct or special nuclear material in quantities not sufficient to form a critical mass, is deemed to possess a like license issued under this subsection and the statutes. The license shall expire either 90 days after receipt from the Department of a notice of expiration of the license, or on the date of expiration specified in the NRC license, whichever is earlier.
12.2 Incorporation by reference.
12.2.1 Except as provided in this subsection,
the requirements of 10 C.F.R. Part 30 (relating to rules of general
applicability to domestic licensing of byproduct material) are incorporated by
reference.
The unofficial version can be accessed at http://www.nrc.gov/. The official version is also available in hard copy. In 10 C.F.R. 30.10(b), the reference to 10 C.F.R. 2 relating to deliberate misconduct is replaced with 18 VSA §1651 - 1657 and Radioactive Material Program Procedure Section 2.5, Enforcement, Escalated Enforcement and Administrative Actions. In 10 C.F.R. 30.50(c)(1), a reference to "NRC Operations Center" means "Department". In 10 C.F.R. 30.50(c)(2), reference to written reports means 'Written reports must be sent to: Vermont Department of Health, 108 Cherry Street, Suite 201, Burlington Vermont 05401, Attn: Radioactive Materials Program."
12.2.2 Notwithstanding the requirements
incorporated by reference, Sections
30.5; 30.6; 30.8; 30.21(c); 30.34(d) and
(e)(1) and (3); 30.41(b)(6); 30.55; 30.63; 30.64 and the words "common defense
and security" in the definitions for "Commencement of Construction" and
"Construction" in 10 C.F.R.
30.4 are not incorporated. In
10 C.F.R.
30.10(b), the reference to
10 C.F.R.
2, relating to deliberate misconduct, is
replaced with 18 V.S.A. §1651 - 1657 and Radioactive Material
Program Procedure Section
2.5, Enforcement, Escalated Enforcement and
Administrative Actions. In 10 C.F.R. 30.50
(c)(1), a reference to "NRC Operations
Center" means "Department." In
10 C.F.R.
30.50(c)(2), reference to
written reports means written reports must be sent to: Vermont Department of
Health, 108 Cherry Street, Suite 201, Burlington, Vermont 05401, Attn:
Radioactive Materials Program.
12.3 Filing applications for specific license
In addition to incorporation by reference, an application for a specific
license shall be accompanied by the fee required under Subsection
5.0 (relating to fees).
12.4 Renewal of licenses.
An application for renewal of a specific license shall be filed under Subsection 11.0 (relating to licensing of radioactive material).
12.4.1 If a renewal
application is filed prior to 30 days before the expiration of a license, the
existing license does not expire until definitive notice has been given by the
Department of its action on the renewal application.
12.4.2 This paragraph also applies to new
license applications incorporating other licenses.
12.5 General licenses for radioactive
material
12.5.1 Incorporation by reference.
12.5.1.1 Except as provided in this
subsection, the requirements of 10 C.F.R. Part 31 (relating to general domestic
licenses for byproduct material) are incorporated by reference. The unofficial
version can be accessed at http://www.nrc.gov/. The official version is
also available in hard copy.
12.5.1.2 Notwithstanding the requirements
incorporated by reference, Sections
31.4,
31.22 and
31.23 are not incorporated. In
10 C.F.R.
31.5(c)(7), the phrase "part
110" is replaced by "10 C.F.R. part 110." In
10 C.F.R.
31, the term "any non-agreement state" means
"Vermont."
12.5.2 Certain
measuring, gauging or controlling devices.
12.5.2.1 In addition to the parts of
10 C.F.R.
31.5 (relating to certain detecting,
measuring, gauging, or controlling devices and certain devices for producing
light or an ionized atmosphere) incorporated by reference, general licensees
subject to registration under
10 C.F.R.
31.5(c)(13)(i) or possessing
general licensed devices containing 37 MBq (1 mCi) or more of
accelerator-produced material, as determined on the date of manufacture, or 3.7
MBq (0.1 mCi) or more of radium-226 shall also comply with the
following:
12.5.2.2 Conduct a
physical inventory every six months to account for all sources or devices, or
both, received and possessed under this subsection and do the following:
12.5.2.2.1 Maintain the physical inventory
records for three years from the date of each inventory.
12.5.2.2.2 Furnish a report to the Department
annually showing to the extent practicable, the make, model, serial number,
isotope, source activity and location of each device. The report shall list an
individual to contact regarding questions about this report.
12.5.3 For portable
devices, also comply with the following:
12.5.3.1 A person who initiates acquisition,
transfer or disposal of a portable device shall notify the Department within 15
days of the action. Sending a portable device for calibration, maintenance or
source replacement does not constitute transfer.
12.5.3.2 Portable devices may only be used by
or under the direct supervision of individuals who have been instructed in the
operating and emergency procedures necessary to ensure safe use.
12.5.3.3 For each individual that the
licensee permits to use a portable device, the licensee shall maintain a record
showing the type of device use permitted and the basis, such as training
certificates, for that authorization. An individual's record shall be kept for
at least 3 years after the individual terminates association with the
licensee.
12.5.3.4 Portable devices
shall be secured from access by unauthorized personnel whenever the device is
not under the direct surveillance of an individual authorized to use the
device.
12.5.3.5 The licensee shall
maintain a current sign out log at the permanent storage location of the
portable device. Log entries shall be available for inspection by the
Department for 3 years from the date of entry. The following information shall
be recorded for each portable device:
12.5.3.5.1 The model and serial number of the
device.
12.5.3.5.2 The name of the
assigned user.
12.5.3.5.3 The
locations and dates of use.
12.5.3.6 Emergency instructions shall
accompany each portable device taken off the premises of the
licensee.
12.5.4
Incidental radioactive material produced by a particle accelerator
12.5.4.1 A general license is issued to
possess radioactive material produced incidentally to the operation of a
particle accelerator. The general license is also subject to the applicable
provisions of this subsection and Subsections
1.0,
6.0, and 7.0 (relating to general
provisions; standards for protection against radiation; and notices,
instructions and reports to workers; inspections and investigations).
12.5.4.2 A licensee may transfer this
radioactive material only under Subsection
6.0 and Subsection
18.0 (relating to transfer of radioactive
material; and packaging and transportation of radioactive material).
12.5.4.3 A licensee may dispose of this
radioactive material only with Department
approval.
12.6
Specific licenses to manufacture or transfer certain items containing
radioactive material.
12.6.1 Incorporation by
reference
12.6.1.1 Except as provided in this
subsection, the requirements of 10 C.F.R. Part 32 (relating to specific
domestic licenses to manufacture or transfer certain items containing byproduct
material) are incorporated by reference. The unofficial version can be accessed
at http://www.nrc.gov/. The official
version is also available in hard copy.
12.6.1.2 Notwithstanding the requirements
incorporated by reference, Sections
32.1(c)(1),
32.8,
32.11,
32.12,
32.14,
32.15,
32.16,
32.18,
32.19,
32.20,
32.21,
32.21 a, 32.22, 32.23, 32.25, 32.26,
32.27, 32.28, 32.29, 32.30, 32.31 and 32.32 are not incorporated.
12.7 Specific Domestic Licenses of Broad
Scope for Radioactive Material.
12.7.1
Incorporation by reference
12.7.1.1 Except as
provided in this subsection, the requirements of 10 C.F.R. Part 33 (relating to
specific domestic licenses of broad scope for byproduct material) are
incorporated by reference. The unofficial version can be accessed at
http://www.nrc.gov/. The official
version is also available in hard copy.
12.7.1.2 Notwithstanding the requirements
incorporated by reference, Sections
33.8,
33.21 and
33.23 are not
incorporated.
12.7.2
Inclusion of naturally occurring or accelerator-produced radioactive material
(NARM)
The requirements of 10 C.F.R. 33, relating to specific licenses of broad scope for radioactive material, also apply to NARM.
12.8 Licensing of source material
12.8.1 Incorporation by reference. Except as
provided in this subsection, the requirements of 10 C.F.R. Part 40 (relating to
domestic licensing of source material) are incorporated by reference. The
unofficial version can be accessed at http://www.nrc.gov/. The official version is
also available in hard copy.
12.8.2
Notwithstanding the requirements incorporated by reference, Sections
40.6; 40.8; 40.12(b); 40.13 (c)(5)(iv), (j)
and (m); 40.23; 40.27; 40.28; 40.31(j),(k),(l) and (m); 40.32(d) and (g) and
those portions of paragraph (e) which apply to uranium enrichment and uranium
hexafluoride facilities; 40.33; 40.38; 40.41(d), (e)(1), (e)(3), (g) and (h);
40.51(b)(6); 40.52; 40.53; 40.56; 40.64; 40.66; 40.67; 40.81; and 40.82;
Appendix A to Part 40; and the words "common defense and security" in the
definitions for "Commencement of Construction" and "Construction" in
10 C.F.R.
40.4 are not incorporated. In
10 C.F.R.
40.10, the reference to
10 C.F.R.
2, relating to deliberate misconduct, is
replaced with 18 V.S.A. §1651-1657 and Radioactive Material
Program Procedure Section
2.5, Enforcement, Escalated Enforcement and
Administrative Actions. In 10 C.F.R. 40.4 the terms "Foreign
Obligations" and "Reconciliation" are not incorporated. In
10 C.F.R.
40.4, the phrase "and any other material
which the Commission, pursuant to the provision of section
51 of the Act, determines to be special
nuclear material" is preserved without change. In
10 C.F.R.
40.10(b) the reference to
10 C.F.R.
2 subpart B is replaced by 18 V.S.A. §130. In
10 CFR
40.60, reference to written reports means
"Written reports must be sent to: Vermont Department of Health, 108 Cherry
Street, Suite 201, Burlington, Vermont 05401, Attn: Radioactive Materials
Program."
12.8.3 Only the NRC can
issue a license pursuant to 10 C.F.R.
40.52.
12.9 Licensing of special nuclear material
12.9.1 Incorporation by reference. Except as
provided in this subsection, the requirements of 10 C.F.R. Part 70 (relating to
domestic licensing of special nuclear material) are incorporated by reference.
The unofficial version can be accessed at http://www.nrc.gov/. The official version is
also available in hard copy. In section
70.10, the phrase "the procedures in 10
C.F.R. part 2 subpart B" is replaced with 18 V.S.A. §130. In 70.19(a)(1), the terms Commission
and Atomic Energy Commission remain.
12.9.2 Notwithstanding the requirements
incorporated by reference, Sections
70.1(c), (d) and (e);
70.5; 70.6; 70.8; 70.13; 70.14; 70.20a; 70.20b; 70.21(a)(1), (c), (f), (g) and
(h); 70.22(b), (c), (f), (g), (h), (i), (j), (k), (l), (m) and (n);
70.23(a)(6), (7), (8), (9), (10), (11) and (12) and (b); 70.23a; 70.24;
70.25(a)(1); 70.31(c), (d) and (e); 70.32(a)(1), (4), (5), (6) and (7);
70.32(b)(1), (3) and (4), (c), (d), (e), (f), (g), (h), (i), (j) and (k);
70.37; 70.40; 70.42(b)(6); 70.44; 70.51(c); 70.52; 70.55(c)(1), (2) and (3);
70.56(c) and (d); 70.59; 70.60; 70.61; 70.64; 70.65; 70.66; 70.72; 70.73;
70.74; 70.76; 70.82; Appendix A to Part 70 and the words "common defense and
security" in the definitions for "Commencement of Construction" and
"Construction" in 10 C.F.R.
70.4 are not incorporated. In
10 C.F.R.
70.10, the reference to
10 C.F.R.
2, relating to deliberate misconduct, is
replaced with 18 V.S.A. §1651-1657 and Radioactive Material
Program Procedures Section
2.5, Enforcement, Escalated Enforcement and
Administrative Action. In 70.19(a)(1) and 70.19(c)(3), the terms "Commission or
the Atomic Energy Commission" remains and does not mean the "Department." In
10 C.F.R.
70.4, the phrase "and any other material
which the Commission, pursuant to the provisions of section
51 of the Act, determines to be special
nuclear material" is preserved without change. In
10 CFR
70.50(c), preparation and
submission of reports, all communications are to be made to the Vermont
Department of Health 108 Cherry Street, Suite 201, Attn: Radioactive Materials
Program, Burlington Vermont 05401, and by telephone at 802-863-7200 for
immediate and 24-hour reports.
12.9.3 In
10 C.F.R.
70.42(b)(1), the word
"Department" means the "US Department of Energy."
12.10 Transfer of radioactive material The
requirements of 10 C.F.R.
30.41 (relating to transfer of byproduct
material) also apply to NARM.
12.10.1
Incorporation by reference. Except as provided in this subsection, the
requirements of 10 C.F.R.
150.1,
150.2,
150.3 (excluding the definition of
"Foreign Obligations"), 150.11 and 150.20 are incorporated by reference. The
unofficial version may be accessed at http://www.nrc.gov/. An official hard copy
version is also available.
12.10.2
The Department may withdraw, limit or qualify its acceptance of a specific
license or equivalent licensing document issued by another agency, or product
distributed under the licensing document, upon determining that the action is
necessary to prevent a public health hazard as defined in 18 V.S.A. §2 (9).
12.10.3 Implementation of the requirements of
this subsection regarding byproduct, source and special nuclear material is
subject to paragraph 12.2 (relating to persons possessing a license for source,
byproduct or special nuclear material in quantities not sufficient to form a
critical mass on the date Vermont becomes an agreement state as published in
the Federal Register).
13.0 Physical Protection of Category 1 and
Category 2 Quantities of Radioactive Material.
13.1 Purpose and scope
13.1.1 This subsection establishes the
requirements for the physical protection program for any licensee that
possesses an aggregated category 1 or category 2 quantity of radioactive
material listed in Appendix A to 10 C.F.R. Part 37 Category 1 and Category 2
Radioactive Materials.
13.1.2 No
provision of this subsection authorizes possession of licensed
material.
13.2
Incorporation by reference
13.2.1 Except as
provided in this subsection, the requirements of 10 C.F.R. Part 37 (relating to
physical protection of category 1 and category 2 quantities of radioactive
materials) are incorporated by reference. The unofficial version can be
accessed at http://www.nrc.gov. The
official version is also available in hard copy.
13.2.2 Notwithstanding the requirements
incorporated by reference, Sections
37.3(b)(2),
37.13,
37.73(d) and (e),
37.107 and
37.109 are not
incorporated.
14.0 Medical Use of Byproduct Material.
14.1 Purpose and scope
14.1.1 This subsection prescribes
requirements and provisions for the medical use of radioactive material and for
issuance of specific licenses authorizing the medical use of radioactive
material.
These requirements and provisions provide for the protection of the public health and safety.
14.1.2 The requirements of this chapter are
in addition to, and not in substitution for, other applicable requirements in
these regulations.
14.2
Incorporation by reference.
14.2.1 Except as
provided in this subsection, the requirements of 10 C.F.R. Part 35 (relating to
medical use of byproduct material) are incorporated by reference. The
unofficial version can be accessed at http://www.nrc.gov. The official version is
also available in hard copy.
14.2.2
Notwithstanding the requirements incorporated by reference, Sections
35.8,
35.11(c)(1),
35.13(a)(1),
35.4001 and
35.4002 are not incorporated.
14.3 Authorization for
calibration, transmission and reference sources Notwithstanding the
incorporation by reference of
10 C.F.R.
35.65 (relating to authorization for
calibration, transmission, and reference sources), a licensee authorized for
medical use of radioactive materials may not receive, possess or use radium in
total quantity of 3.7 MBq (100 ?ci) or more for check, calibration,
transmission and reference use except as specifically authorized by the
Department.
15.0 Licenses
for Industrial Radiography and Radiation Safety Requirements for Industrial
Radiographic Operations.
15.1 Purpose and
Scope This subsection establishes radiation safety requirements for persons
using radioactive materials for industrial radiography.
15.2 Incorporation by reference
15.2.1 Except as provided in this subsection,
the requirements of 10 C.F.R. Part 34 (relating to licenses for industrial
radiography and radiation safety requirements for industrial radiographic
operations) are incorporated by reference. The unofficial version can be
accessed at http://www.nrc.gov/. The
official version is also available in hard copy.
15.2.2 Notwithstanding the requirements
incorporated by reference, Sections
34.5,
34.8,
34.121 and
34.123 are not
incorporated.
15.3
Prohibitions Use of radiation sources covered under this subsection for
diagnosis or therapy on humans or animals is not permitted.
16.0 Licenses and Radiation Safety
Requirements for Well Logging.
16.1 Purpose
and Scope.
This subsection establishes radiation safety requirements for persons using radiation sources for well logging in a single well, radioactive markers, uranium sinker bars and subsurface tracer studies. Persons who use radiation sources for well logging operations shall comply with this subsection, which is in addition to and not in substitution for other applicable requirements of this Rule.
16.2 Incorporation by reference
16.2.1 Except as provided in this subsection,
the requirements of 10 C.F.R. Part 39 (relating to licenses and radiation
safety requirements for well logging) are incorporated by reference. The
unofficial version can be accessed at http://www.nrc.gov/. The official version is
also available in hard copy.
16.2.2
Notwithstanding the requirements incorporated by reference, Sections
39.5,
39.8,
39.101 and
39.103 are not
incorporated.
17.0 Licenses and Radiation Safety
Requirements for Irradiators.
17.1 Purpose and
scope
17.1.1 This subsection contains the
requirements for the issuance of a license authorizing the use of radioactive
materials in sealed sources to irradiate objects or materials with gamma
radiation.
17.1.2 The requirements
of this subsection are in addition to, and not in substitution for, other
applicable requirements in this regulation.
17.2 Incorporation by reference
17.2.1 Except as provided in this subsection,
the requirements of 10 C.F.R. Part 36 (relating to licenses and radiation
safety requirements for irradiators) are incorporated by reference. The
unofficial version can be accessed at http://www.nrc.gov/. The official version is
also available in hard copy.
17.2.2
Notwithstanding the requirements incorporated by reference, Sections
36.5,
36.8,
36.91,
36.93 and the words "common defense and
security" in the definitions for "Commencement of Construction" and
"Construction" in 10 C.F.R.
36.2 are not
incorporated.
18.0 Packaging and Transportation of
Radioactive Material.
18.1 Purpose and scope
This subsection establishes requirements for packaging, preparation for
shipment and transportation of radioactive material. This subsection applies to
a person who transports radioactive material or delivers radioactive material
to a carrier for transport.
18.2
Incorporation by reference.
18.2.1 Except as
provided in this subsection, the requirements of 10 C.F.R. Part 71 (relating to
packaging and transportation of radioactive material) are incorporated by
reference. The unofficial version can be accessed at
http://www.nrc.gov/. The official
version is also available in hard copy.
18.2.2 Notwithstanding the requirements
incorporated by reference, Sections
71.2; 71.6; 71.11; 71.14(b); 71.19; 71.31;
71.33; 71.35; 71.37; 71.38; 71.39; 71.41; 71.43; 71.45; 71.51; 71.55; 71.59;
71.61; 71.63; 71.64; 71.65; 71.70; 71.71; 71.73; 71.74; 71.75; 71.77; 71.85(a),
(b) and (c); 71.91(b); 71.99; 71.100; 71.101(c)(2), (d) and (e); 71.107;
71.109; 71.111; 71.113; 71.115; 71.117; 71.119; 71.121; 71.123 and 71.125 are
not incorporated. In 10
C.F.R. 71 Subpart H the terms "Certificate of
Compliance," "certificate holder," and "applicant for CoC" apply only to the
NRC. In 10 C.F.R.
71.17(c)(3), the submission
required before the first use of an NRC approved package should be sent to the
NRC, ATTN: Document Control Desk, Director, Division of Spent Fuel Storage and
Transportation, Office of Nuclear Material Safety and Safeguards, using an
appropriate method listed in §71.1(a), the licensee's
name and license number and the package identification number specified in the
package approval.
18.3
Transportation of licensed material
In addition to the incorporation by reference of 10 C.F.R. Part 71 (relating to packaging and transportation of radioactive material), if VSA Title 23 (relating to interstate motor carrier safety requirements; intrastate motor carrier requirements; and hazardous materials transportation) or the regulations of the United States Department of Transportation in 49 C.F.R. Parts 171--180 and 388--397 do not apply to a shipment of licensed material, the licensee shall conform to the standards and requirements of those regulations to the same extent as if the shipment was subject to the regulations.
19.0
Waste Classification.
Characteristics and Labeling: The requirements of 10 C.F.R. 61. 55, 61.56 and 61.57 (relating to classification characterization and labeling of radioactive wastes) are incorporated by reference. The official version can be accessed at http://www.nrc.gov/. The official version is also available in hard copy.
PART C: VERMONT YANKEE NUCLEAR POWER STATION
(VYNPS)
1.0 Purpose and Scope.
Part C of this Rule establishes requirements for the protection of public health and safety as related to the site-boundary of the Vermont Yankee Nuclear Power Station (VYNPS).
2.0 Criteria Applicable to VYNPS Relating to
Members of the Public.
2.1 The maximum
permissible total effective dose equivalent of members of the public in
unrestricted areas from all regulated uses of ionizing radiation shall be kept
as low as reasonably achievable (ALARA) and shall not exceed the values
specified below:
2.1.1 Discharges of
radioactive materials and direct gamma radiation to unrestricted areas shall be
controlled as follows:
2.1.1.1 Gaseous
Effluents
The annual committed effective dose equivalent limit for an individual in an unrestricted area due to plant emissions of radioactive noble gases is 5 millirem. The committed effective dose equivalent from noble gases is calculated using noble gas concentrations in air samples obtained by the Department and as reported by VYNPS.
2.1.1.2 Liquid Effluents
The annual committed effective dose equivalent limit for an individual in an unrestricted area, due to plant discharges of liquid effluents is 5 millirem. The committed effective dose equivalent from liquid effluents is calculated using liquid effluent concentrations in water samples obtained by the Department and as reported by VYNPS.
2.1.1.3 Radioiodine
The annual committed effective dose equivalent limit of an individual in an unrestricted area due to plant emissions of radioiodine is 5 millirem. The committed effective dose equivalent from radioiodines is calculated using radioiodine concentrations in air samples obtained by the Department and as reported by VYNPS.
2.1.1.4 Radioactive Particulates
The annual committed effective dose equivalent limit for an individual in an unrestricted area due to plant emissions of radioactive particulates is 5 millirem. The committed effective dose equivalent from radioactive particulates is calculated using radioactive particulate concentrations in air samples obtained by the Department and as reported by VYNPS.
2.1.1.5 Direct Gamma
Radiation
2.1.1.5.1 The annual effective dose
equivalent limit for a member of the public in an unrestricted area due to
plant emanations of direct gamma radiation is 5 millirem. For the purpose of
this subsection, a measured exposure value of 20 milliroentgen per year above
background radiation at any point on the site boundary bordered by land shall
be considered equivalent to a 5 millirem effective dose equivalent for a member
of the public in an unrestricted area.
2.1.1.5.2 If any site boundary, bordered by
land, quarterly measured-exposure value exceeds 10 milliroentgen above
background radiation, VYNPS shall take the actions described in Section
4.0.
3.0 Compliance with Dose Limits for Members
of the Public.
3.1 VYNPS shall submit an
annual report to the Department detailing the surveys and calculations of
discharges of all radioactive materials and direct gamma radiation from all
operations and activities at the plant and specifically addressing each of the
applicable criteria specified in this Rule. The annual report shall be due no
later than May 15 for the prior calendar year.
3.2 VYNPS shall submit monthly reports to the
Department detailing the surveys and calculations of direct gamma radiation
from all operations and activities at the plant and specifically addressing the
quarterly and annual direct gamma radiation exposure limits specified in this
Rule. The monthly reports shall include copies of all records of all
instruments used to monitor public exposure, including all records of
calibration of the main steam line radiation monitors and all reports relevant
to the off-site dose calculation manual issued or created during the report
period. The monthly reports shall be due no later than the 15th of the month
for the prior calendar month.
3.3
For purposes of the annual and monthly reports, VYNPS shall calculate the
committed effective dose equivalent of discharges of radioactive materials and
shall report the measured exposure values of direct gamma radiation to
unrestricted areas as provided in the most current VYNPS Off-Site Dose
Calculation Manual as approved by the Nuclear Regulatory Commission, and shall
report all measured exposure values from all other instruments used by VYNPS to
monitor public exposure.
3.4 VYNPS
shall provide any other information requested by the Department relating to the
information and underlying data and calculations in the annual and monthly
reports.
4.0 Required
Actions Regarding Dose Limit Exceedances.
4.1
VYNPS shall take the following actions as soon as it becomes evident that the
quarterly or annual committed effective dose equivalents or measured exposure
values exceed, or may exceed, the limits specified in this Rule, but in no
event later than the last day of the calendar quarter in which the discharge
exceeds these values:
4.1.1 Immediately
report the discharge or direct gamma radiation exceedance to the
Department.
4.1.2 Immediately make
an investigation to identify the causes of the exceedance, or anticipated
exceedance, of maximum limits for committed effective dose equivalent or
measured exposure values, including an evaluation of all discharges of
radioactive materials or direct gamma radiation that contributed to the
exceedance, and initiate a program designed to ensure that future discharges
will be maintained at or below values not likely to cause exceedance of the
maximum limits for committed effective dose equivalent or measured exposure
values specified in this Rule. As soon as possible, VYNPS shall report to the
Department the action taken or proposed to be taken to achieve immediate
reduction of the discharges for the Department's approval; and
4.1.3 VYNPS shall implement the plan approved
by the Department with all reasonable speed.
4.1.4 Within 14 days, but in no event later
than 10 days after the end of the calendar quarter, submit a report to the
Department detailing the actions described above and providing verification of
the completion of the implementation of the plan approved by the
Department.
5.0
Independent Compliance Monitoring by the Department.
5.1 The Department shall conduct
environmental surveys and sampling and shall deploy appropriate instruments to
measure discharges of radioactive materials and direct gamma radiation
emanations from VYNPS. The Department shall use that information to determine
compliance with the requirements established in this Rule.
6.0 Inspections.
6.1 All regulated entities who receive,
possess, use or transfer sources of ionizing radiation shall:
6.1.1 Provide the Commissioner with copies
of all reports furnished to the NRC related to radioactive effluent discharges
and gamma radiation emanations under normal or abnormal operating
conditions.
6.1.2 Permit the
Commissioner at all times the opportunity to inspect and evaluate sources of
radiation and the premises and facilities wherein such sources of radiation are
used or stored, and shall make available pertinent data, as well as records and
reports as may be required by the Department.
6.1.3 Grant to the Commissioner access to all
records pertaining to the radiological health and safety of employees, to
discharges of radioactive material and gamma radiation emanations to the
environment, and to any effect of the operation of the facility upon the
environment.
6.1.4 Provide the same
notice to the Commissioner of any radiological incident and reports thereof and
in the same manner as provided to the NRC.
6.1.5 Permit the Commissioner to make
unscheduled visits to the regulated facility for the purpose of obtaining
samples and surveys for analysis.
6.1.6 Upon request by the Commissioner, VYNPS
shall furnish advance notification of each scheduled calibration of effluent
monitors and shall permit the Commissioner to be present during such
calibration.
6.1.7 Upon request by
the Commissioner, VYNPS shall share samples of environmental media for purposes
of data correlation.
7.0 Notice, Corrective Actions and
Enforcement.
7.1 Whenever the Department has
reasonable grounds to believe that there has been a violation of any of the
provisions of this Rule, the Department shall take appropriate action as
provided in this subsection or otherwise provided in law, in order to protect
the public health and safety.
7.2
If an inspection, including the Department's independent compliance monitoring
of VYNPS, indicates that the regulated entity is not in compliance with the
requirements of this Rule, the Department shall notify the regulated entity in
writing, with full particulars regarding any deficiencies.
7.2.1 The notice shall include specific
required corrective actions necessary for the regulated entity to take to
regain compliance with this Rule and may include interim corrective actions,
such as requiring further investigation of the circumstances giving rise to the
notice, or ceasing use of the source of radiation until such time as full
compliance is restored, or such other action deemed necessary by the Department
to protect the public health and safety is completed.
7.2.2 A regulated entity shall respond to the
Department within the time specified in the notice, which shall be determined
by the risk associated with the alleged non-compliance.
7.2.3 If the regulated entity fails to timely
and satisfactorily comply with the requirements of the notice, the Department
shall initiate an enforcement action.
7.3 If the Department determines that an
enforcement action is appropriate, or if timely and satisfactory compliance
with a notice issued pursuant to subsection (B) of this subsection has not been
achieved, the Department shall issue a notice of violation in writing. The
notice shall specify the nature of the violation and required action to restore
full compliance. If the Department determines that enforcement action is
required, the Department shall:
7.3.1 refer
the matter to the Attorney General for injunction proceedings consistent with
18 V.S.A. §1656, or
7.3.2 in the event of an emergency, take
immediate action consistent with 18 V.S.A. §1655 (b), or
7.3.3 initiate a proceeding before the Board
by issuing a written notice of the alleged violation to the regulated entity
and filing the notice with the Board. The Board shall convene a contested case
proceeding pursuant to 3 V.S.A. §809 and
18 V.S.A. §1655. On the basis of the evidence produced
at the hearing the Board shall make findings of fact and conclusions of law and
enter such order as in its opinion will best further the purposes of this Rule
and applicable law and shall give written notice of such order to the alleged
violator, the Department and to any other parties to the proceeding,
or
7.3.4 take such other action in
the discretion of the Commissioner as authorized by law.
7.4 An appeal of any order issued by the
Board pursuant to this subsection shall be to the superior court as provided in
18 V.S.A. §1655(c)
8.0 Transportation.
8.1 Persons transporting or shipping
radioactive materials into, out of, through, or within the state shall provide
notification to the Commissioner prior to such shipment or transport if such
shipment or transport meets any of the following criteria:
8.1.1 Any shipment or package containing a
large quantity of radioactive material regulated by the NRC or US Department of
Transportation (DOT).
8.1.2 Fuel
elements which have been utilized in a nuclear reactor.
8.1.3 Any Fissile Class I, Class II, or Class
III package regulated by the DOT.
8.1.4 Any road, rail, air or sea transport of
radioactive waste material for disposal.
8.2 The shipper shall supply the following
information in writing or by telephone to the Commissioner at least two working
days prior to shipment. Schedule changes or additional information must be
provided no later than two hours prior to shipment. To avoid undue hardship the
Commissioner may approve other reporting schedules requested by the shipper.
8.2.1 Name of shipper;
8.2.2 Name of carrier;
8.2.3 Type and quantity of radioactive
material;
8.2.4 Date and time of
shipment;
8.2.5 Starting point,
scheduled route, and destination; and
8.2.6 Other information required by the
Commissioner.
8.3
Shipments shall be made throughout the state with due regard to public health
and safety. The Commissioner may require 'changes in dates, routes or time of
shipment if necessary to maximize protection to public health and safety. Where
possible, the Commissioner shall coordinate such changes with their
counterparts in adjoining political jurisdictions.
Notes
November 7, 1977, Secretary of State Rule Log #77-164
AMENDED:
January 1, 2010, Secretary of State Rule Log #09-033; March 1, 2019 Secretary of State Rule Log #19-002 [Part B]; January 1, 2024 Secretary of State Rule Log #23-013
STATUTORY AUTHORITY:
3 V.S.A. §§801, 3003; 18 V.S.A. §1652
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