Code of Vermont Rules › Agency 13 - AGENCY OF HUMAN SERVICES › Sub-Agency 140 - DEPARTMENT OF HEALTH › Chapter 030 - RADIOLOGICAL HEALTH › Section 13 140 030 - RADIOLOGICAL HEALTH

Current through June, 2024
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.
5.14.2. Qualified Medical Physicists for
				mammography shall meet the requirements specified by the Mammography Quality
				Standards Act of 1992, Public Law 102-539,
				42 U.S.C.
				263b, and 21 CFR Part
				900.
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).