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

Universal Citation: 105 CMR 120.000 MA Code of Regs 120.405

Current through Register 1531, September 27, 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.

(2) Fluoroscopic Beam Limitation.
(a) For certified fluoroscopic systems with or without a spot film device, neither the length nor the width of the x-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than 3% of the SID. The sum of the excess length and the excess width shall be no greater than 4% of the SID.

(b) For uncertified fluoroscopic systems with a spot film device, the x-ray beam with the shutters fully opened (during fluoroscopy or spot filming) shall be no larger than the largest spot film size for which the device is designed. Measurements shall be made at the minimum SID available but at no less than 20 centimeters table top to the film plane distance.

(c) For uncertified fluoroscopic systems without a spot film device, the requirements of 120.405(A)(2)(a) apply.
1. Means shall be provided to permit further limitation of the field. Beam-limiting devices manufactured after May 22, 1979, and incorporated in equipment with a variable SID and/or a visible area of greater than 300 square centimeters shall be provided with means for stepless adjustment of the x-ray field;

2. All equipment with a fixed SID and a visible area of 300 square centimeters or less shall be provided with either stepless adjustment of the x-ray field or with means to further limit the x-ray field size at the plane of the image receptor to 125 square centimeters or less;

3. If provided, stepless adjustment shall, at the greatest SID, provide continuous field sizes from the maximum attainable to a field size of five centimeters by five centimeters or less;

4. For equipment manufactured after February 25, 1978, when the angle between the image receptor and beam axis is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor; and,

5. For rectangular x-ray fields used with circular image receptors, the error in alignment shall be determined along the length and width dimensions of the x-ray field which pass through the center of the visible area of the image receptor.

(d) For fluoroscopic equipment manufactured on or after June 10, 2006, other than radiation simulation systems, the maximum area of the x-ray field in the plane of the image receptor shall conform with one of the following requirements:
1. When any linear dimension of the visible area of the image receptor measured through the center of the visible area is less than or equal to 34 cm in any direction, at least 80% of the area of the x-ray field overlaps the visible area of the image receptor; or

2. When any linear dimension of the visible area of the image receptor measured through the center of the visible area is greater than 34 cm in any direction, the x-ray field measured along the direction of greatest misalignment with the visible area of the image receptor does not extend beyond the edge of the visible area of the image receptor by more than two cm.

(3) Spot-film Beam limitation. Spot-film devices shall meet the following requirements:
(a) Means shall be provided between the source and the patient for adjustment of the x-ray field size in the plane of the film to the size of that portion of the film which has been selected on the spot film selector. Such adjustment shall be automatically accomplished except when the x-ray field size in the plane of the film is smaller than that of the selected portion of the film. For spot film devices manufactured after June 21, 1979, if the x-ray field size is less than the size of the selected portion of the film, the means for adjustment of the field size shall be only at the operator's option;

(b) Neither the length nor the width of the x-ray field in the plane of the image receptor shall differ from the corresponding dimensions of the selected portion of the image receptor by more than 3% of the SID when adjusted for full coverage of the selected portion of the image receptor. The sum, without regard to sign, of the length and width differences shall not exceed 4% of the SID;

(c) It shall be possible to adjust the x-ray field size in the plane of the film to a size smaller than the selected portion of the film. The minimum field size at the greatest SID shall be equal to, or less than, five centimeters by five centimeters;

(d) The center of the x-ray field in the plane of the film shall be aligned with the center of the selected portion of the film to within 2% of the SID; and,

(e) On spot-film devices manufactured after February 25, 1978, if the angle between the plane of the image receptor and beam axis is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor, and compliance shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.

(4) Override. If a means exists to override any of the automatic x-ray field size adjustments required in 105 CMR 120.405(A)(2), that means:
(a) Shall be designed for use only in the event of system failure;

(b) Shall incorporate a signal visible at the fluoroscopist's position which will indicate whenever the automatic field size adjustment is overridden; and,

(c) Shall be clearly and durably labeled as follows:

FOR X-RAY FIELD

LIMITATION SYSTEM FAILURE

(B) Activation of the Fluoroscopic Tube. X-ray production in the fluoroscopic mode shall be controlled by a device which requires continuous pressure by the fluoroscopist for the entire time of any exposure. When recording serial fluoroscopic images, the fluoroscopist shall be able to terminate the x-ray exposure(s) at any time, but means may be provided to permit completion of any single exposure of the series in process.

(C) Air Kerma Rates .

(1) Fluoroscopic Equipment Manufactured Before May 19, 1995.
(a) Fluoroscopic equipment which is provided with automatic exposure rate control shall not be operable at any combination of tube potential and current which will result in AKR in excess of 88 mGy per minute (ten roentgens) per minute at the point where the center of the useful beam enters the patient, except:
1. During recording of fluoroscopic images; or

2. When provided with optional high level control, the equipment shall not be operable at any combination of tube potential and current which will result in an AKR in excess of ten roentgens (88 mGy) per minute at the point where the center of the useful beam enters the patient unless the high level control is activated. Special means of activation of high level controls shall be required. The high level control shall only be operable when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high level control is being employed.

(b) Fluoroscopic equipment which is not provided with automatic exposure rate control shall not be operable at any combination of tube potential and current which will result in AKR in excess of 44 mGy (five roentgens) per minute at the point where the center of the useful beam enters the patient, except:
1. During recording of fluoroscopic images; or

2. When an optional high level control is activated. Special means of activation of high level controls shall be required. The high level control shall only be operable when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high level control is being employed.

(c) Fluoroscopic equipment which is provided with both automatic exposure rate control mode and a manual mode shall not be operable at any combination of tube potential and current which shall result in an AKR in excess of 88 mGy (ten roentgens) per minute in either mode at the point where the center of the useful beam enters the patient, except:
1. During recording of fluoroscopic images; or

2. When the mode or modes have an optional high level control, in which case that mode or modes shall not be operable at any combination of tube potential and current which shall result in an AKR in excess of 88 mGy (ten roentgens) per minute at the point where the center of the useful beam enters the patient, unless high level control is activated. Special means of activation of high level controls shall be required. The high level control shall only be operable when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high level control is being employed.

(2) Fluoroscopic Equipment Manufactured On or After May 19, 1995.
(a) Shall be equipped with automatic exposure rate control if operable at any combination of tube potential and current that results in an AKR greater than 44 mGy per minute (five R/min exposure rate) at the measurement point specified in 105 CMR 120.405(C)(3). Provision for manual selection of technique factors may be provided.

(b) Shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (ten R/min exposure rate) at the measurement point specified in 105 CMR 120.405(C)(3).

(c) Exceptions:
1. For equipment manufactured prior to June 10, 2006, during the recording of images from a fluoroscopic image receptor using photographic film or a video camera when the x-ray source is operated in a pulsed mode.

2. For equipment manufactured on or after June 10, 2006, during the recording of images from the fluoroscopic image receptor for the purpose of providing the user with a recorded image(s) after termination of the exposure. Such recording does not include images resulting from a last-image-hold feature that are not recorded.

3. When a mode of operation has an optional high-level control and the control is activated, in which case the equipment shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 176 mGy per minute (20 R/min exposure rate) at the measurement point specified in 105 CMR 120.405(C)(3). Special means of activation of high-level controls shall be required. The high-level control shall be operable only when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high-level control is employed.

(3) Compliance with the requirements of 105 CMR 120.405(C) shall be determined as follows:
(a) If the source is below the table, the AKR shall be measured one centimeter above the tabletop or cradle.

(b) If the source is above the table, the AKR shall be measured at 30 centimeters above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement.

(c) For a C-arm type of fluoroscope, the AKR shall be measured 30 centimeters from the input surface of the fluoroscopic imaging assembly, with the source positioned at any available SID, provided that the end of the beam-limiting device or spacer is no closer than 30 centimeters from the input surface of the fluoroscopic imaging assembly;

(d) For a lateral type fluoroscope, the air kerma rate shall be measured at a point 15 centimeters from the centerline of the x-ray table and in the direction of the x-ray source with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. If the tabletop is movable, it shall be positioned as closely as possible to the lateral x-ray source, with the end of the beam-limiting device or spacer no closer than 15 centimeters to the centerline of the x-ray table.

(e) In a C-arm type of fluoroscope having an SID less than 45 cm, the AKR shall be measured at the minimum SSD.

(4) The registrant of a facility or responsible person at the facility shall have a qualified medical physicist perform periodic measurement of AKR for both typical and maximum values as follows:
(a) Such measurements shall be made annually or after any maintenance of the system which might affect the AKR;

(b) If the fluoroscope does not display the AKR of the current patient in view of the operator when the fluoroscopy trigger is depressed, results of these measurements shall be posted where any fluoroscopist may have ready access to such results while using the fluoroscope and in the record required in 105 CMR 120.403(A)(2)(b). The measurement results shall be stated in coulombs per kilogram (roentgens) per minute and include the technique factors used in determining such results. The name of the individual performing the measurements and the date the measurements were performed shall be included in the results;

(c) Conditions of periodic measurement of typical AKR are as follows:
1. The measurement shall be made under the conditions that satisfy the requirements of 105 CMR 120.405(C)(1)(c);

2. The kVp, mA, and/or other selectable parameters shall be adjusted to those settings typical of clinical use for an abdominal patient;

3. The x-ray system that incorporates automatic Exposure rate control shall have sufficient attenuative material placed in the useful beam to produce a milliamperage and/or kilovoltage to satisfy the conditions of 105 CMR 120.405(C)(1)(e)3.; and

(d) Conditions of periodic measurement of maximum AKR are as follows:
1. The measurement shall be made under the conditions that satisfy the requirements of 105 CMR 120.405(C)(1)(c);

2. The kVp, mA and/or other selectable parameters shall be adjusted to those settings which give the maximum AKR;

3. The x-ray system(s) that incorporates automatic exposure rate control shall have sufficient attentuative material placed in the useful beam to produce the maximum AKR of the system.

(D) Barrier Transmitted Radiation Rate Limits.

(1) The AKR due to transmission through the primary protective barrier with the attenuation block in the useful beam, combined with radiation from the image intensifier, if provided, shall not exceed two milliroentgen (0.516 µC/kg) per hour at ten centimeters from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor for each roentgen per minute of AKR.

(2) Measuring Compliance of Barrier Transmission.
(a) The AKR due to transmission through the primary protective barrier combined with radiation from the image intensifier shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.

(b) If the source is below the tabletop, the measurement shall be made with the input surface of the fluoroscopic imaging assembly positioned 30 centimeters above the tabletop.

(c) If the source is above the tabletop and the SID is variable, the measurement shall be made with the end of the beam-limiting device or spacer as close to the tabletop as it can be placed, provided that it shall not be closer than 30 centimeters.

(d) Movable grids and compression devices shall be removed from the useful beam during the measurement.

(e) The attenuation block shall be positioned in the useful beam ten centimeters from the point of measurement of AKR and between this point and the input surface of the fluoroscopic imaging assembly.

(E) Indication of Potential and Current. During fluoroscopy and cinefluorography the kV and the mA shall be continuously indicated.

(F) Source-to-skin Distance.

(1) Means shall be provided to limit the source-skin distance to not less than 38 cm on stationary fluoroscopes and to not less than 30 cm on mobile and portable fluoroscopes. In addition, for fluoroscopes intended for specific surgical application that would be prohibited at the source-skin distances specified in 105 CMR 120.405(D)(1), provisions may be made for operating at shorter source-skin distances but in no case less than 20 cm.

(2) For stationary, mobile, or portable C-arm fluoroscopic systems manufactured on or after June 10, 2006, having a maximum source-image receptor distance of less than 45 cm, means shall be provided to limit the source-skin distance to not less than 19 cm. Such systems shall be labeled for extremity use only. In addition, for those systems intended for specific surgical application that would be prohibited at the source-skin distance specified in 105 CMR 120.405(F)(2), provisions may be made for operation at shorter source-skin distances but in no case less than ten cm.

(G) Fluoroscopic Timer.

(1) Fluoroscopic Equipment Manufactured Before June 10, 2006:
(a) Means shall be provided to preset the cumulative on-time of the fluoroscopic x-ray tube. The maximum cumulative time of the timing device shall not exceed five minutes without resetting.

(b) A signal audible to the fluoroscopist shall indicate the completion of any preset cumulative on-time. Such signal shall continue to sound while x-rays are produced until the timing device is reset.

(2) For x-ray controls manufactured on or after June 10, 2006, there shall be provided for each fluoroscopic tube:
(a) A display of the fluoroscopic irradiation time at the fluoroscopist's working position. This display shall function independently of the audible signal described in 105 CMR 120.405(G)(2). The following requirements apply:
1. When the x-ray tube is activated, the fluoroscopic irradiation time in minutes and tenths of minutes shall be continuously displayed and updated at least once every six seconds.

2. The fluoroscopic irradiation time shall also be displayed within six seconds of termination of an exposure and remain displayed until reset.

3. Means shall be provided to reset the display to zero prior to the beginning of a new examination or procedure.

(b) A signal audible to the fluoroscopist shall sound for each passage of five minutes of fluoroscopic irradiation time during an examination or procedure. The signal shall sound until manually reset or, if automatically reset, for at least two seconds.

(H) Control of Scattered Radiation.

(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.

(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:
(a) Is at least 120 centimeters from the center of the useful beam; or

(b) The radiation has passed through not less than 0.25 millimeter lead equivalent material including, but not limited to, drapes, Bucky-slot cover panel, or self-supporting curtains, in addition to any lead equivalency provided by the protective apron referred to in 105 CMR 120.403(A)(1)(e).

(3) The Agency may grant exemptions to 105 CMR 120.405(H)(2) where a sterile field will not permit the use of the normal protective barriers. Where the use of prefitted sterilized covers for the barriers is practical, the Agency shall not permit such exemption. See 105 CMR 120.423: Appendix D for a suggested list of fluoroscopic procedures where such exemptions will be automatically granted.

(I) Radiation Therapy Simulation Systems. Radiation therapy simulation systems shall be exempt from all the requirements of 105 CMR 120.405(A), (C), (D) and (G) provided that:

(1) Such systems are designed and used in such a manner that no individual other than the patient is in the x-ray room during periods of time when the system is producing x-rays; and,

(2) Systems which do not meet the requirements of 105 CMR 120.405(G) are provided with a means of indicating the cumulative time that an individual patient has been exposed to x-rays. Procedures shall require in such cases that the timer be reset between examinations.

(J) Spot film Exposure Reproducibility. Fluoroscopic systems equipped with spot film (radiographic) modes shall meet the exposure reproducibility requirements when operating in the spot film mode.

(K) Operator Qualifications.

(1) The Registrant of a facility shall ensure that only the following health care providers shall be allowed to operate fluoroscopic x-ray systems:
(a) Licensed physicians who are board-certified in radiology;

(b) Licensed physicians who are not board-certified in radiology provided that they have been trained in the following subjects:
1. Principles and operation of the fluoroscopic x-ray system;

2. Biological effects of x-ray;

3. Principles of radiation protection;

4. Fluoroscopic outputs;

5. High level control options;

6. Dose reduction techniques for fluoroscopic x-ray systems; and

7. Application requirements of 105 CMR 120.000.

(c) Radiologic technologists who are licensed in accordance with 105 CMR 125.000 and have been trained in the safe use of fluoroscopic x-ray systems; and

(d) Physician assistants who are licensed in accordance with M.G.L. c. 112, § 9I, and 263 CMR 3.00: Registration of Individual Physician Assistants, and who meet the requirements of 105 CMR 120.405(K)(2).

(2) The Registrant of a facility shall ensure that a physician assistant delegated the performance of specified fluoroscopic procedures by a supervising physician has submitted documentation of the following to the facility:
(a) Successful completion of the education and clinical training specified in 105 CMR 120.405(K)(3) offered by an approved provider;

(b) a passing score on an examination offered by the American Registry of Radiologic Technologists (ARRT) or equivalent exam approved by the Agency covering the educational and clinical requirements specified in 105 CMR 120.405(K)(3);

(c) a written and signed statement from the physician assistant's supervising physician, who meets the requirements of 105 CMR 120.405(K)(1)(a) or (b), verifying the physician assistant's competency to perform specified fluoroscopic procedures; and

(d) a written practice agreement between the physician assistant and his or her supervising physician as set forth in regulations of the Board of Registration in Medicine at 243 CMR 2.08 and of the Board of Registration of Physician Assistants in 263 CMR 5.00: Scope of Practice and Employment of Physician Assistants.

(3) The education and clinical training required by 105 CMR 120.405(K)(2)(a) shall consist of the following:
(a) Didactic Content
1. Digital image acquisition and display;

2. Contrast media;

3. Fluoroscopic unit operation and safety;

4. Image analysis;

5. Radiation biology;

6. Radiation production and characteristics; and

7. Radiation protection.

(b) Clinical Component
1. Clinical competency requirement: 40 clinical hours performing fluoroscopic procedures in a fluoroscopic suite under the direct supervision of a physician who meets the requirements of 105 CMR 120.405(K)(1)(a) or (b), a medical physicist, or a radiography educator. "Direct supervision," as used in 105 CMR 120.405(K)(3), means physically present where the fluoroscopic procedure is being performed and immediately available and able to provide assistance and direction throughout the procedure;

2. Fluoroscopic device orientation: safe and proper manipulation of the fluoroscopic device.

(4) The Registrant of the facility and/or responsible person at the facility shall maintain all records relating to compliance with the education and clinical training requirements for the current year and the previous four years.

(5) The facility shall establish policies and procedures for limiting the performance of fluoroscopic procedures to only those health care providers who have met the requirements of 105 CMR 120.405(K) and who have been granted privileges for the use of fluoroscopy based on their demonstrated competency in the performance of fluoroscopic procedures.

(6) The Registrant of the facility shall ensure that all physicians who are not board certified in radiology and who perform fluoroscopic procedures complete two hours of training in Radiation Safety/Radiation Protection on an annual basis, and that all physicians who are not board certified in radiology who supervise the performance of fluoroscopic procedures complete a total of four hours of Radiation Safety/Radiation Protection training on an annual basis. The facility shall maintain all records relating to compliance with this training requirement for the current year and the previous four years.

(7) The Registrant of a facility shall ensure that licensed radiologic technologists and licensed physician assistants who perform fluoroscopic procedures have satisfied all related continuing education requirements as required by their respective licensing boards, and shall maintain records documenting completion of such continuing education requirements by radiologic technologists and physician assistants for five years.

(8) In addition to any other reporting requirements, the facility shall immediately, and no later than 24 hours after discovery, report to the Agency any incident at the facility involving fluoroscopic procedures that seriously affects the health and safety of a patient or that causes serious physical injury to a patient due to radiation exposure.

(9) Nothing in 105 CMR 120.405(K) shall prohibit nurse practitioners from practicing within their lawful scope of practice, including functioning as first assistants during cardiac catheterization procedures in accordance with 105 CMR 130.900: Standards for Operation of Hospital-based Cardiac Catheterization Services, and the Board of Registration in Nursing Advisory Ruling Number 0201, Nurse Practitioner as First Assistant in Cardiac Catherization, provided that the physician who is the primary operator, as defined in 105 CMR 130.910, is qualified to operate fluoroscopic x-ray systems pursuant to 105 CMR 120.405(K)(1)(a) or (b).

(L) Patient Dose Evaluation.

(1) Each facility performing fluoroscopically-guided interventional and CT fluoro procedures shall conduct patient dose evaluation for any procedure that has a reasonable probability of resulting in a deterministic injury as further defined in 105 CMR 120.405(L)(5).

(2) Records documenting that policies and procedures have been developed to determine that those procedures that have a potential to result in patient doses exceeding the threshold for injury have been established to reduce the probability of such exposures and that appropriate action occurs for patients receiving doses that warrant follow-up.

(3) The facility shall have a patient dose monitoring procedures in place. When the fluoroscopy unit is equipped with an Air-Kerma dose readout, the recording of this value shall suffice as a patient dose record.

(4) The facility shall document in the patient's medical record an estimate of the absorbed dose to the skin.

(5) Any cumulative absorbed dose to the skin equal to or greater than 2 Gy (200 rads) shall be noted in the patient's medical record and reviewed by the Radiation Safety Committee.

(6) Each facility that use fluoroscopic x-ray systems shall maintain a record of the cumulative fluoroscopic exposure time used and the number of spot films for each examination. This record shall indicate patient identification, type of examination, date of examination, and operator's name. The record shall be maintained for five years.

(M) Equipment Operation.

(1) Radiological technology students shall not be allowed to operate fluoroscopic x-ray systems unless directly supervised by a licensed practitioner of the healing arts or a licensed Radiological Technologist.

(2) Overhead fluoroscopy shall not be used as a positioning tool for general purpose radiographic examinations.

(N) Mini-C-Arms. 105 CMR 120.405 includes Mini-C-Arms.

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