reglab/statecodes huggingface dataset:
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RADIATION SAFETY REQUIREMENTS › Section 120.337 - Special Requirements and Exemptions for Enclosed Radiography

Current through Register 1525, July 5, 2024
(A) Systems for enclosed radiography,
				including shielded-room radiography and cabinet x-ray systems not otherwise
				exempted, shall comply with all applicable requirements of 105 CMR
				120.300.
(B) Systems for enclosed
				radiography designed to allow admittance of individuals shall be evaluated at
				intervals not to exceed one year to ensure compliance with the applicable
				requirements of 105 CMR 120.300,
				120.221(A)
				 and
				120.222.
				Records of these evaluations shall be maintained for Agency inspection for five
				years after the evaluation.
(C)
				Certified cabinet x-ray systems are exempt from the requirements of 105 CMR
				120.300 except that:
(1) The registrant shall
				comply with the requirements of 105 CMR 120.020 and 120.200.
(2) Tests for proper operation of interlocks
				must be conducted and recorded in accordance with
				105 CMR
				120.319. Records of these tests shall be
				maintained for Agency inspection until disposal is authorized by the
				Agency.
(3) The registrant shall
				perform an evaluation to determine compliance with
				21 CFR
				1020.40 at intervals not to exceed one year.
				Records of these evaluations shall be maintained for Agency inspection for five
				years after the evaluation.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RADIATION SAFETY REQUIREMENTS › Section 120.340 - Underwater and Lay-barge Radiography

Current through Register 1525, July 5, 2024
(A)
				Underwater and/or lay-barge radiography shall not be performed unless
				specifically authorized in a license issued by the agency in accordance with
				105 CMR
				120.360.
(B) In addition to the other requirements of
				105 CMR 120.300, the following requirements apply to the performance of
				lay-barge radiography:
(1) Cobalt-60 sources
				with activities in excess of 740 GBq (20 Ci) (nominal) and iridium-192 sources
				with activities in excess of 3.70 TBq (100 Ci) (nominal) shall not be used in
				the performance of offshore platform or lay-barge radiography.
(2) Collimators shall be used for all
				industrial radiographic operations performed on lay-barges.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RADIATION SAFETY REQUIREMENTS › Section 120.350 - Prohibitions

Current through Register 1525, July 5, 2024
(A) Industrial radiography performed with a
				sealed source that is not fastened to or contained in a radiographic exposure
				device (fishpole technique) is prohibited unless specifically authorized in a
				license issued by the agency.
(B)
				Retrieval of disconnected sources or sources that cannot be returned by normal
				means to a fully shielded position or automatically secured in the radiographic
				exposure device, shall not be performed unless specifically authorized by a
				license condition.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.360 - Records for Industrial Radiography

Current through Register 1525, July 5, 2024
Each licensee or registrant shall maintain a copy of its
				  license or registration, documents incorporated by reference, and amendments to
				  each of these items until superseded by new documents approved by the Agency,
				  or until the Agency terminates the license or registration.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.361 - Records of Receipt, Transfer, and Disposal of Sources of Radiation

Current through Register 1525, July 5, 2024
(A) Each licensee or registrant shall
				maintain records showing the receipts, transfers and disposal of sealed
				sources, devices using DU for shielding, and radiation machines, and retain
				each record for five years after it is made.
(B) These records must include the date, the
				name of the individual making the record, radionuclide, number of becquerels
				(curies) or mass (for DU), and manufacturer, model, and serial number of each
				source of radiation and/or device, as appropriate.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.362 - Records of Radiation Survey Instruments

Current through Register 1525, July 5, 2024
Each licensee or registrant shall maintain records of the
				  calibrations of its radiation survey instruments that are required under
				  105 CMR
				  120.314 and retain each record for three
				  years after it is made.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.363 - Records of Leak Testing of Sealed Sources and Devices Containing DU

Current through Register 1525, July 5, 2024
Each licensee shall maintain records of leak test results for
				  sealed sources and for devices containing DU. The results must be stated in
				  units of becquerels (/Ci). The licensee shall retain each record for five years
				  after it is made or until the source in storage is removed.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.364 - Records of Quarterly Inventory

Current through Register 1525, July 5, 2024
(A) Each
				licensee or registrant shall maintain records of the quarterly inventory of
				sources of radiation, including devices containing depleted uranium as required
				by
				105 CMR
				120.316 and retain each record for five
				years.
(B) The record must include
				the date of the inventory, name of the individual conducting the inventory,
				radionuclide, number of becquerels (curies) or mass (for DU) in each device,
				location of sources of radiation and/or devices, and manufacturer, model, and
				serial number of each source of radiation and/or device, as
				appropriate.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.365 - Utilization Logs

Current through Register 1525, July 5, 2024
Each licensee and registrant shall maintain current logs of
				  the use of each source of radiation. The logs shall include:
(A) A unique identification (e.g., serial
				number) of each radiation machine, each radiographic exposure device in which a
				sealed source is located, and each sealed source;
(B) The name of the radiographer using the
				source of radiation;
(C) The
				location(s) where each source of radiation is used and dates of use;
				and,
(D) The date(s) each source of
				radiation is removed from storage and returned to storage. For fixed
				installations, the date(s) each source of radiation is energized or used and
				the number of exposures made. Utilization logs may be kept on form MRCP
				120.300-2, Utilization Log, or on clear, legible records containing all the
				information required by 105 CMR 120.365(A) through (D). Copies of utilization
				logs shall be maintained for Agency inspection for five years. The records
				shall be kept at the location specified by the license or certificate of
				registration.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.366 - Records of Inspections and Maintenance of Radiation Machines, Radiographic Exposure Devices, Transport and Storage Containers, associated Equipment, Source Changers, and Survey Instruments

Current through Register 1525, July 5, 2024
(A) Each licensee or registrant shall
				maintain records specified in
				105
				CMR 120.318 of equipment problems found in
				daily checks and quarterly inspections of radiation machines, radiographic
				exposure devices, transport and storage containers, associated equipment,
				source changers, and survey instruments; and retain each record for three years
				after it is made.
(B) 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.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.367 - Records of Alarm System and Entrance Control Tests at Permanent Radiographic Installations

Current through Register 1525, July 5, 2024
Each licensee or registrant shall maintain records of alarm
				  system and entrance control device tests required by
				  105 CMR
				  120.319 and retain each record for three
				  years after it is made.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.368 - Records of Training and Certification

Current through Register 1525, July 5, 2024
Each licensee or registrant shall maintain the following
				  records for five years:
(A) Records of
				training of each radiographer and each radiographer trainee. The record must
				include radiographer certification documents and verification of certification
				status, copies of written tests and the dates of oral and practical
				examinations administered by the licensee or registrant, the names of
				individuals conducting and receiving the oral and practical examinations, and a
				list of items tested and the results of the oral and practical examinations;
				and,
(B) Records of annual
				refresher safety training and semi-annual inspections of job performance for
				each radiographer and each radiographer's assistant. The records must list the
				topics discussed during the refresher safety training, the dates the annual
				refresher safety training was conducted, and names of the instructors and
				attendees. For inspections of job performance, the records must also include a
				list showing the items checked and any non-compliance observed by the radiation
				safety officer or designee.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.369 - Copies of Operating and Emergency Procedures

Current through Register 1525, July 5, 2024
Each licensee or registrant shall maintain a copy of current
				  operating and emergency procedures until the Agency terminates the license or
				  registration. Superseded material must be retained for five years after the
				  change is made.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.370 - Records of Personnel Monitoring

Current through Register 1525, July 5, 2024
Each licensee or registrant shall maintain the following
				  exposure records specified in
				  105 CMR
				  120.323:
(A) Direct reading dosimeter readings and
				yearly operability checks required by
				105 CMR 120.323(B)(8)
				 for five years after the record is
				made;
(B) Records of alarming
				ratemeter calibrations for five years after the record is made;
(C) Reports received from the personnel
				monitoring badge processor until the Agency terminates the license or
				registration; and,
(D) Records of
				estimates of exposures as a result of off-scale personal direct reading
				dosimeters, or lost or damaged personnel monitoring badges until the Agency
				terminates the license or registration.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.371 - Records of Radiation Surveys

Current through Register 1525, July 5, 2024
Each licensee or registrant shall maintain a record of each
				  survey as specified in
				  105 CMR
				  120.333(E). Each record must
				  be maintained for five years after it is made.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.372 - Form of Records

Current through Register 1525, July 5, 2024
Each record required by
				  105 CMR
				  120.360 through 120.372 must be legible
				  throughout the specified retention period. The record may be the original or a
				  reproduced copy or a microform provided that the copy or microform is
				  authenticated by authorized personnel and that the microform is capable of
				  reproducing a clear copy throughout the required retention period. The record
				  may also be stored in electronic media with the capability for producing
				  legible, accurate, and complete records during the required retention period.
				  Records, such as letters, drawings, and specifications, must include all
				  pertinent information, such as stamps, initials, and signatures. The licensee
				  or registrant shall maintain adequate safeguards against tampering with and
				  loss of records.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.373 - Location of Documents and Records

Current through Register 1525, July 5, 2024
(A) Each
				licensee or registrant shall maintain copies of records required by 105 CMR
				120.300 and other applicable Parts of 120.CMR 120.000 at the location specified
				in
				105
				CMR 120.305(K).
(B) Each licensee or registrant shall also
				maintain current copies of the following documents and records sufficient to
				demonstrate compliance at each applicable field station and each temporary
				Jobsite;
(1) The license or registration
				authorizing the use of sources of radiation;
(2) A copy of 105 CMR 120.001105 CMR 120.200,
				105 CMR 120.300 and 105 CMR 120.750;
(3) Utilization logs for each source of
				radiation dispatched from that location as required by
				105 CMR
				120.317;
(4) Records of equipment problems identified
				in daily checks of equipment as required by
				105
				CMR 120.366(A);
(5) Records of alarm system and entrance
				control checks required by
				105
				CMR 120.366, if applicable;
(6) Records of dosimeter readings as required
				by
				105 CMR
				120.369;
(7) Operating and emergency procedures as
				required by
				105 CMR
				120.325;
(8) Evidence of the latest calibration of the
				radiation survey instruments in use at the site, as required by
				105 CMR
				120.362;
(9) Evidence of the latest calibrations of
				alarming ratemeters and operability checks of dosimeters as required by
				105 CMR
				120.369;
(10) Survey records as required by
				105 CMR
				120.370, for the period of operation at the
				site;
(11) The shipping papers for
				the transportation of radioactive materials required by 105 CMR 120.770;
				and,
(12) When operating under
				reciprocity pursuant to 105 CMR 120.100, a copy of the applicable State license
				or registration, or Nuclear Regulatory Commission license authorizing the use
				of sources of radiation
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.380 - Radiation Safety Officer

Current through Register 1525, July 5, 2024
The radiation safety officer shall ensure that radiation
				  safety activities are being performed in accordance with approved procedures
				  and regulatory requirements in the daily operation of the licensee's or
				  registrant's program.
(A) The minimum
				qualifications, training, and experience for radiation safety officers for
				industrial radiography are as follows:
(1)
				Completion of the training and testing requirements of
				105 CMR
				120.320(B);
(2) 2000 hours of hands-on experience as a
				qualified radiographer in industrial radiographic operations; and,
(3) Formal training in the establishment and
				maintenance of a radiation protection program.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.385 - Notifications

Current through Register 1525, July 5, 2024
(A) The Agency shall be notified of the loss
				or theft of sources of radiation, overexposures, and excessive levels in
				accordance with
				105
				CMR 120.281,
				120.282,
				120.283,
				and
				120.288.
(B) In addition, each licensee or registrant
				shall submit a written report within 30 days to the Agency whenever one of the
				following events occurs:
(1) A source assembly
				cannot be returned to the fully-shielded position and properly
				secured;
(2) The source assembly
				becomes unintentionally disconnected from the drive cable;
(3) Any component critical to safe operation
				of the radiographic exposure device fails to properly perform its intended
				function; or,
(4) An indicator on a
				radiation-producing machine fails to show that radiation is being produced, an
				exposure switch fails to terminate production of radiation when turned to the
				off position, or a safety interlock fails to terminate X-ray
				production.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.390 - Reciprocity

Current through Register 1525, July 5, 2024
All reciprocal recognition of licenses and certificates of
				  registration by the Agency will be granted in accordance with
				  105 CMR
				  120.190 and
				  120.033.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.401 - Purpose and Scope

Current through Register 1525, July 5, 2024
105 CMR
				  120.400 establishes requirements, for which a
				  registrant is responsible, for use of X-ray equipment by or under the
				  supervision of an individual authorized by and licensed in accordance with
				  Commonwealth statutes to engage in the healing arts or veterinary medicine. The
				  provisions of
				  105 CMR
				  120.400 are in addition to, and not in
				  substitution for, other applicable provisions of
				  105
				  CMR 120.000.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.404 - General Requirements for All Diagnostic X-ray Systems

Current through Register 1525, July 5, 2024
In addition to other requirements of 105 CMR 120.400, all
				  diagnostic x-ray systems shall meet the following requirements:
(A)
Warning Label
.
				The control panel containing the main power switch shall bear the warning
				statement, legible and accessible to view: "WARNING: This x-ray unit may be
				dangerous to patient and operator unless safe exposure factors and operating
				instructions are observed."
(B)
Battery Charge Indicator
. On battery-powered x-ray
				generators, visual means shall be provided on the control panel to indicate
				whether the battery is in a state of charge adequate for proper
				operation.
(C)
Leakage
				Radiation from the Diagnostic Source Assembly
. The leakage
				radiation from the diagnostic source assembly measured at a distance of one
				meter in any direction from the source shall not exceed 100 milliroentgen (25.8
				/C/kg) in one hour when the x-ray tube is operated at its leakage technique
				factors. Compliance shall be determined by measurements averaged over an area
				of 100 square centimeters with no linear dimension greater than 20
				centimeters.
(D)
Radiation from Components Other Than the Diagnostic Source
				Assembly
. The radiation emitted by a component other than the
				diagnostic source assembly shall not exceed two milliroentgen (0.516 /C/kg) in
				one hour at five centimeters from any accessible surface of the component when
				it is operated in an assembled x-ray system under any conditions for which it
				was designed. Compliance shall be determined by measurements averaged over an
				area of 100 square centimeters with no linear dimension greater than 20
				centimeters.
(E)
Beam
				Quality.
(1)
Half-value Layer
.
(a) The half-value layer of the useful beam
				for a given x-ray tube potential shall not be less than the values shown in
				Table I. If it is necessary to determine such half-value layer at an x-ray tube
				potential which is not listed in Table I, linear interpolation or extrapolation
				may be made.
(b) For capacitor
				energy storage equipment, compliance with the requirements of 105 CMR
				120.404(E) shall be determined with the system fully charged and a setting of
				ten mAs for each exposure.
(c) The
				required minimal aluminum equivalent filtration shall include the filtration
				contributed by all materials which are always present between the source and
				the patient.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.405 - Fluoroscopic X-ray Systems

Current through Register 1525, July 5, 2024
Fluoroscopic X-ray Systems shall be installed and maintained
				  to comply with the Federal Performance Standard for Fluoroscopic Equipment,
				  21 CFR
				  1020.32 and shall also meet the following
				  requirements except
				  21 CFR
				  1020.32 shall prevail should there be a
				  conflict.
(A)
Limitation
				of Useful Beam
.
(1)
Primary Barrier
.
(a)
				The fluoroscopic imaging assembly shall be provided with a primary protective
				barrier which intercepts the entire cross section of the useful beam at any
				SID.
(b) The x-ray tube used for
				fluoroscopy shall not produce x-rays unless the barrier is in position to
				intercept the entire useful beam.
(c) Radiation therapy simulation systems
				shall be exempt from 105 CMR 120.405(A) provided the systems are intended only
				for remote control operation.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.406 - Diagnostic X-ray Systems

Current through Register 1525, July 5, 2024
(A)
Beam Limitation Except for Mammographic Systems
. The
				useful beam shall be limited to the area of clinical interest. This shall be
				deemed to have been met if a positive beam limiting device meeting
				manufacturer's specifications and the requirements of 105 CMR 120.406(G)(2) has
				been properly used or if evidence of collimation is shown on at least three
				sides or three corners of the film (for example, projections from the shutters
				of the collimator, cone cutting at the corners, or borders at the film's edge).
(1)
General Purpose Stationary
				and Mobile X-ray Systems, Including Veterinary Systems (Other than Portable)
				Installed After December 31, 1997.
(a) Only x-ray systems provided with a means
				for independent stepless adjustment of at least two dimensions of the x-ray
				field shall be used;
(b) A method
				shall be provided for visually defining the perimeter of the x-ray field. 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;
(c) The Agency may grant an exemption on
				non-certified x-ray systems to 105 CMR 120.406(A)(1)(a); and,
(d) Provided the registrant makes a written
				application for such exemption and in that application:
1. Demonstrates it is impractical to comply
				with 105 CMR 120.406(A)(1)(a) and (b); and,
2. The purpose of 105 CMR 120.406(A)(1)(a)
				and (b) will be met by other methods.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.407 - Dental Radiographic Systems

Current through Register 1525, July 5, 2024
(A)
General Requirements.
(1)
Timers
. Means
				shall be provided to terminate the exposure at a preset time interval, preset
				product of current and time, a preset number of pulses, or a preset radiation
exposure
to the image receptor. In addition, it shall
				not be possible to make an exposure when the timer is set to a "zero" or "off"
				position if either position is provided.
(2)
Reproducibility
.
				With a timer setting of 0.3 second or less, the average exposure period (T)
				shall be greater than or equal to five times the maximum exposure period
				(Tmax) minus the minimum exposure period
				(Tmin) when 4 timer tests are performed:
T >= 5(Tmax -
				  Tmin )
(3)
X-ray Control
.
(a) An x-ray control shall be incorporated
				into each x-ray system such that an exposure can be terminated by the operator
				at any time, except for exposures of 0.5 second or less.
(b) The exposure switch shall be of the
				dead-man type.
(c) Each x-ray
				control shall be located in such a way as to permit the operator to remain in
				an area of less than two millirems in any one hour during the entire
				exposure.
(4)
Exposure Reproducibility
. The coefficient of variation
				shall not exceed 0.10 when all technique factors are held constant. This
				requirement shall be deemed to have been met if, when four
Exposures
are made at identical technique factors, the
				value of the average
Exposure
(E) is greater than or
				equal to five times the maximum
Exposure
(Emax) minus the minimum
Exposure
(Emin):
E >= 5(Emax -
				  Emin)
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.408 - Veterinary X-ray Systems

Current through Register 1525, July 5, 2024
(A)
Equipment.
(1)
Technique and Exposure Indicators
.
(a) The technique factors to be used during
				an exposure shall be indicated before the exposure begins. If automatic
				exposure controls are used, the technique factors which are set prior to the
				exposure shall be indicated.
(b)
				The requirements of 105 CMR 120.408(A)(1) may be met by permanent markings on
				equipment having fixed technique factors. Indication of technique factors shall
				be visible from the operator's position except in the case of spot films made
				by the fluoroscopist.
(c) The x-ray
				control shall provide visual indication of the production of x-rays observable
				at or from the operator's protected position whenever x-rays are
				produced.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.410 - Bone Densitometry

Current through Register 1525, July 5, 2024
(A) Bone
				Densitometry Systems shall be:
(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.;
(2)
				Registered in accordance with 105 CMR 120.020;
(3) Maintained and operated in accordance
				with the manufacturer's specifications.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.420 - Appendix A - Radiation Shielding and Safety Requirements

Current through Register 1525, July 5, 2024
In order for the Radiation Control Program to provide an
				  evaluation, and official approval on shielding requirements for a radiation
				  installation, the following must be submitted. The plans shall show as a
				  minimum the following:
(A) The normal
				location of the x-ray system's radiation port, the port's travel and transverse
				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.
(B) The structural
				composition and thickness or lead equivalent of all walls, doors, partitions,
				floor and ceiling of the room(s) concerned.
(C) The dimensions of the room(s)
				concerned.
(D) The type of
				occupancy of all adjacent areas inclusive of space above and below the room(s)
				concerned. If there is any exterior wall, show distance to the closest area(s)
				where it is likely that individuals will be present.
(E) The make and model of the x-ray
				equipment.
(F) The typical type of
				examination(s) and treatment(s) which will be performed with the
				equipment.
(G) Information on the
				anticipated workload of the x-ray system(s).
(H) An interlock and/or warning light shall
				be installed at all egresses. For diagnostic x-ray installations, the warning
				light shall be wired to the rotor of the x-ray system.
(I) All basic assumptions used to determine
				the shielding requirements in developing these plans shall be submitted with
				these plans.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.421 - Appendix B - Information to be Submitted by Persons Proposing to Conduct Healing Arts Screening

Current through Register 1525, July 5, 2024
Persons requesting that the Agency approve a healing arts
				  screening program shall submit the following information and evaluation:
(A) Name and address of the applicant and,
				where applicable, the names and addresses of agents within this
				Commonwealth.
(B) Diseases or
				conditions for which the x-ray examinations are to be used in
				diagnoses.
(C) A detailed
				description of the x-ray examinations proposed in the screening
				program.
(D) Description of the
				population to be examined in the screening program,
i.e.,
age,
				sex, physical condition, and other appropriate information.
(E) An evaluation of any known alternate
				methods not involving ionizing radiation, which would achieve the goals of the
				screening program and why these methods are not used instead of the x-ray
				examinations.
(F) An evaluation by
				a qualified expert of the x-ray system(s) to be used in the screening program.
				The evaluation by the qualified expert shall show that such system(s) do
				satisfy all requirements of 105 CMR 120.000.
(G) A description of the diagnostic film
				quality control program.
(H) A copy
				of the technique charts for the x-ray examination procedures to be
				used.
(I) The qualifications of
				each individual who will be operating the x-ray system(s).
(J) The qualifications of the individual 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.
(K) The name and address
				of the individual who will interpret the radiograph(s).
(L) Procedures to be used in advising the
				individuals screened and their practitioner of the healing arts or healthcare
				provider of the results of the screening procedure and any further medical
				needs indicated.
(M) The duration
				of the screening program.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.422 - Appendix C - Design Requirements for an Operator's Booth

Current through Register 1525, July 5, 2024
(A)
Space
				Requirements
(1) The operator
				shall be allotted not less than 7.5 square feet (0.697
				m2) of unobstructed floor space in the
				booth.
(2) The operator's booth may
				be any geometric configuration with no dimension of less than two feet (0.61
				m).
(3) The space shall be allotted
				excluding any encumbrance by the x-ray control panel, such as overhang, cables
				or other similar encroachments.
(4)
				The booth shall be located or constructed such that unattenuated direct scatter
				radiation originating in the examination table or at the wall cassette shall
				not reach the operator's station in the booth.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.423 - Appendix D - Exemptions from Shielding for Certain Fluoroscopic Procedures

Current through Register 1525, July 5, 2024
(A) Angiograms
(B) Arthrograms
(C) Biliary drainage procedures
(D) Fluoroscopic biopsy procedures
(E) Myelograms
(F) Percutaneous cholangiograms
(G) Percutaneous nephrostomies
(H) Sinograms or fistulograms
(I) T-tube cholangiograms
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.431 - Purpose and Scope

Current through Register 1525, July 5, 2024
(A)105 CMR 120.430
				establishes requirements, for which the registrant is responsible, for use of
				therapeutic radiation machines. The provisions of 105 CMR 120.430 are in
				addition to, and not in substitution for, other applicable provisions of 105
				CMR 120.000.
(B) The use of
				therapeutic radiation machines shall be by, or under the supervision of, a
				licensed practitioner of the healing arts who meets the training/experience
				criteria established by
				105
				CMR 120.433(C).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.433 - General Administrative Requirements for Facilities Using Therapeutic Radiation Machines

Current through Register 1525, July 5, 2024
(A)
Administrative Controls
. The registrant shall be
				responsible for directing the operation of the therapeutic radiation machines
				which have been registered with the Agency. The registrant or the registrant's
				agent shall ensure that the requirements of 105 CMR 120.430 are met in the
				operation of the therapeutic radiation machine(s).
(B)
Prohibition
A
				therapeutic radiation machine which does not meet the provisions of 105 CMR
				120.000 shall not be used for irradiation of patients.
(C)
Training for Therapeutic
				Radiation Machine Authorized Users
The registrant for any
				therapeutic radiation machine subject to
				105 CMR
				120.436 or
				120.437
				shall require the authorized user to be a physician who:
(1) Is certified in:
(a) Radiology or therapeutic radiology by the
				American Board of Radiology; or
(b)
				Radiation oncology by the American Osteopathic Board of Radiology; or
(c) Radiology, with specialization in
				radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of
				the Royal College of Radiology"; or
(d) Therapeutic radiology by the Canadian
				Royal College of Physicians and Surgeons.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.434 - General Technical Requirements for Facilities Using Therapeutic Radiation Machines

Current through Register 1525, July 5, 2024
(A)
Protection Surveys.
(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
				105 CMR
				120.438. The radiation protection survey
				shall be performed by, or under the direction of, a Qualified Medical Physicist
				or a Certified Health 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. The following standards must be met and recorded:
(a) Radiation levels in restricted areas are
				not likely to cause personnel exposures in excess of the limits specified in
				105 CMR
				120.211(A); and,
(b) Radiation levels in unrestricted areas do
				not exceed the limits specified in
				105 CMR
				120.221(A) and
				(B).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.435 - Written Directives

Current through Register 1525, July 5, 2024
(A) A written
				directive, as defined in
				105 CMR 120.432, must
				be dated and signed by an authorized user prior to the administration of
				radiation.
If, because of the emergent nature of the patient's
				  condition, a delay in order to provide a written directive would jeopardize the
				  patient's health, an oral directive will be acceptable, provided that the
				  information contained in the oral directive is documented as soon as possible
				  in writing in the patient's record and a written directive is prepared within
				  48 hours of the oral directive.
(B) The written directive must contain the
				patient or human research subject's name, the type and energy of the beam, the
				total dose, dose per fraction, treatment target volume, and number of
				fractions.
(C)
(1) A written revision to an existing written
				directive may be made provided that the revision is dated and signed by an
				authorized user prior to the administration of the external beam dose, or the
				next fractional dose.
If because of the patient's condition, a delay in the 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 will be
				  acceptable, provided that the oral revision is documented as soon as possible
				  in writing in the patient's record and a revised written directive is signed by
				  an authorized user within 48 hours of the oral revision.
(2) The registrant shall retain a copy of the
				written directive for three years.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.436 - Therapeutic Radiation Machines of Less than 500 kV

Current through Register 1525, July 5, 2024
(A)
Leakage
				Radiation
. When the x-ray tube is operated at its maximum rated
				tube current for the maximum kV, the leakage air kerma rate shall not exceed
				the value specified at the distance specified for that classification of
				therapeutic radiation machine:
(1)
5-50 kV Systems
. The leakage air kerma rate measured
				at any position five centimeters from the tube housing assembly shall not
				exceed one mGy (100 mrad) in any one hour.
(2)
>50 and <500 kV
				Systems
. The leakage air kerma rate measured at a distance of one
				meter from the target in any direction shall not exceed one cGy (one rad) in
				any one hour. This air kerma rate measurement may be averaged over areas no
				larger than 100 square centimeters. In addition, the air kerma rate at a
				distance of five centimeters from the surface of the tube housing assembly
				shall not exceed 30 cGy (30 rad) per hour.
(3) For each therapeutic radiation machine,
				the registrant shall determine, or obtain from the manufacturer, the leakage
				radiation existing at the positions specified in 105 CMR 120.436(A)(1) and (2)
				for the specified operating conditions. Records on leakage radiation
				measurements shall be maintained at the installation for inspection by the
				Agency.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.437 - Therapeutic Radiation Machines - Photon Therapy Systems (500 kV and Above) and Electron Therapy Systems (500 keV and Above)

Current through Register 1525, July 5, 2024
(A)
Possession of Survey
				Instrument(s)
. Each facility location authorized to use a
				therapeutic radiation machine in accordance with 105 CMR 120.437 shall possess
				appropriately calibrated portable monitoring equipment. As a minimum, such
				equipment shall include a portable radiation measurement survey instrument
				capable of measuring dose rates over the range ten Sv (one mrem) per hour to
				ten mSv (1000 mrem) per hour. The survey instrument(s) shall be operable and
				calibrated in accordance with
				105 CMR
				120.438.
(B)
Leakage Radiation Outside the
				Maximum Useful Beam in Photon and Electron Modes.
(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 two meters which is perpendicular
				to and centered on the central axis of the useful beam at the nominal treatment
				distance
(i.e.
patient 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 square centimeters at a minimum of 16 points uniformly
				distributed in the plane;
(2)
				Except for the area defined in 105 CMR 120.437(B)(1), the absorbed dose due to
				leakage radiation (excluding neutrons) at one meter from the electron path
				between the electron source and the target or electron window shall not exceed
				0.5% 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 square centimeters;
(3) For
				equipment manufactured after July 9, 1999, the neutron absorbed dose outside
				the useful beam shall be in compliance with International Electrotechnical
				Commission (IEC) Document 601-2-1 (most current revision); and
(4) For each therapeutic radiation machine,
				the registrant shall determine, or obtain from the manufacturer, the leakage
				radiation existing at the positions specified in 105 CMR 120.437(B)(1) through
				(B)(3) for the specified operating conditions. Records on leakage radiation
				measurements shall be maintained at the installation for inspection by the
				Agency.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.438 - Calibration of Survey Instruments

Current through Register 1525, July 5, 2024
(A) The
				registrant shall ensure that the survey instruments used to show compliance
				with 105 CMR 120.430 have been calibrated before first use, at intervals not to
				exceed 12 months, and following repair.
(B) To satisfy the requirements of 105 CMR
				120.438(A), the registrant shall:
(1)
				Calibrate all required scale readings up to ten mSv (1000 mrem) per hour with
				an appropriate radiation source that is traceable to the National Institute of
				Standards and Technology (NIST);
(2) Calibrate at least two points on each
				scale to be calibrated. These points should be at approximately 1/3 and 2/3 of
				full-scale; and
(3) Calibrate
				automatically ranging digital display survey instruments at no less than one
				point on each decade and at no less than two points on one of these decades.
				These points should be at approximately 1/3 and 2/3 of the decade.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.439 - Shielding and Safety Design Requirements

Current through Register 1525, July 5, 2024
(A)
				Each therapeutic radiation machine subject to
				105 CMR
				120.436 or
				120.437
				shall be provided with such primary and/or secondary barriers as are necessary
				to ensure compliance with
				105 CMR
				120.211 and
				120.221.
(B) 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 Agency approval prior to actual
				installation of the therapeutic radiation machine. The minimum facility design
				information that must be submitted is contained in
				105
				CMR 120.440:
Appendix
				A.
(C)
Quality
				Assurance For Radiation Therapy Simulation Systems.
(1) Quality assurance for a conventional or
				virtual simulator shall include acceptance testing and periodic verification of
				system performance; and
(2) Be
				performed in accordance with "Comprehensive QA for Radiation Oncology: Report
				of AAPM Radiation Therapy Committee Task Group No. 40: AAPM Report No. 46" for
				a conventional simulator; or
(3) Be
				performed in accordance with "Quality assurance for computed tomography
				simulators and the computed tomography-simulation process: Report of the AAPM
				Radiation Therapy Committee Task Group No. 66: AAPM Report No. 83" for a
				virtual simulator.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › RECORDKEEPING REQUIREMENTS › Section 120.440 - Appendix A: Information on Radiation Shielding Required for Plan Reviews

Current through Register 1525, July 5, 2024
I.
ALL THERAPEUTIC RADIATION
				MACHINES
A. Basic facility
				information including: name, telephone number and Agency registration number of
				the individual responsible for preparation of the shielding plan; name and
				telephone number of the facility supervisor; and the street address [including
				room number] of the therapeutic radiation machine facility. The plan should
				also indicate whether this is a new structure or a modification to existing
				structure(s).
B. All wall, floor,
				and ceiling areas struck by the useful beam shall have primary
				barriers.
C. Secondary barriers
				shall be provided in all wall, floor, and ceiling areas not having primary
				barriers.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL INFORMATION › Section 120.501 - Purpose and Scope

Current through Register 1525, July 5, 2024
105 CMR
				  120.500 establishes requirements and
				  provisions for the production, preparation, compounding and use of
				  radionuclides in the healing arts and for issuance of licenses authorizing
				  these activities. These requirements and provisions provide for the radiation
				  safety of workers, the general public, patients, and human research subjects.
				  The requirements and provisions of
				  105 CMR
				  120.500 are in addition to, and not in
				  substitution for, others in
				  105
				  CMR 120.000. The requirements and provisions of
				  105
				  CMR 120.000 apply to applicants and licensees subject
				  to
				  105 CMR
				  120.500, unless specifically exempted.
				  (
See
exemption in
				  105 CMR
				  120.104(C)(4))
				  .
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL INFORMATION › Section 120.503 - Maintenance of Records

Current through Register 1525, July 5, 2024
Each record required by
				  105 CMR
				  120.500 must be legible throughout the
				  retention period specified by each Agency regulation. The record may be the
				  original, a reproduced copy, or a microform provided that the copy or microform
				  is authenticated by authorized personnel and the microform is capable of
				  producing a clear copy throughout the required retention period. The record may
				  also be stored in electronic media with the capability for producing legible,
				  accurate, and complete records during the required retention period. Records
				  such as letters, drawings, and specifications, must include all pertinent
				  information such as stamps, initials, and signatures. The licensee shall
				  maintain adequate safeguards against tampering with and loss of
				  records.