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Only image-intensified or direct-digital receptor fluoroscopic equipment shall be used for fluoroscopy.
(a) Acceptance testing of fluoroscopic x-ray units. Acceptance testing of fluoroscopic x-ray units must include all quality assurance tests that are mandated to be done at any frequency (for example, all daily, monthly, and annually required tests, etc.) as per the manufacturer's specifications, or as required by this Article. Each registrant must have acceptance testing conducted on x-ray units with the exception of fluoroscopic mini c-arms of II sizes less than 6 inches prior to clinical patient exams being conducted with the designated x-ray units. The acceptance testing must be conducted by a QMP and the report provided to the registrant. All non-compliance issues noted in this report must be corrected prior to clinical use of the unit. The acceptance testing report must verify the stated manufacturer's tolerances for all machine testing. If manufacturer tolerances are absent, the QMP must develop tolerances that must be used in subsequent quality assurance testing by the registrant and must be so noted in the facility's quality assurance manual.
(b) Primary protective barrier.
(1) Limitation of useful beam. The fluoroscopic imaging assembly must be provided with a primary protective barrier which intercepts the entire cross section of the useful beam at any SID. The x-ray tube used for fluoroscopy must not produce x-rays unless the barrier is in position to intercept the entire useful beam. The AKR due to transmission through the barrier with the attenuation block in the useful beam combined with radiation from the fluoroscopic imaging receptor must not exceed 3.34x10-3 percent of the entrance AKR, at a distance of 10 cm from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor. Radiation therapy simulation systems are exempt from this requirement provided the systems are intended only for remote control operation.
(2) Measuring compliance. The AKR must be measured in accordance with subdivision (i) of this section. If the source is below the tabletop, the measurement must be made with the input surface of the fluoroscopic imaging assembly positioned 30 cm above the tabletop. If the source is above the tabletop and the SID is variable, the measurement must 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 is not closer than 30 cm. Movable grids and compression devices must be removed from the useful beam during the measurement. For all measurements, the attenuation block must be positioned in the useful beam 10 cm from the point of measurement of entrance AKR and between this point and the input surface of the fluoroscopic imaging assembly.
(c) Field limitation.
(1) Angulation. For fluoroscopic equipment manufactured after February 25, 1978, when the angle between the image receptor and the beam axis of the x-ray beam is variable, means must be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor. Compliance with subdivisions (e) and (f) of this section shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.
(2) Further means for limitation. Means must be provided to permit further limitation of the x-ray field to sizes smaller than the limits of subdivisions (e) and (f) of this section. Beam-limiting devices manufactured after May 22, 1979, and incorporated in equipment with a variable SID or capability of a visible area of greater than 300 cm
2
, must be provided with means for stepless adjustment of the x-ray field. Equipment with a fixed SID and the capability of a visible area of no greater than 300 cm
2
must be provided with either stepless adjustment of the x-ray field or with a means to further limit the x-ray field size at the plane of the image receptor to 125 cm
2
or less. Stepless adjustment must, at the greatest SID, provide continuous field sizes from the maximum obtainable to a field size containable in a square of 5 cm by 5 cm.
(i) Means must be provided between the source and the patient for adjustment of the x-ray field size in the plane of the image receptor to the size of that portion of the image receptor which has been selected on the spot-film selector. Such adjustment must be accomplished automatically when the x-ray field size in the plane of the image receptor is greater than the selected portion of the image receptor. If the x-ray field size is less than the size of the selected portion of the image receptor, the field size must not open automatically to the size of the selected portion of the image receptor unless the operator has selected that mode of operation.
(ii) Neither the length nor 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 percent 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 must not exceed 4 percent of the SID. 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 must be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor. Compliance shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.
(iii) The center of the x-ray field in the plane of the image receptor must be aligned with the center of the selected portion of the image receptor to within 2 percent of the SID.
(iv) Means must be provided to reduce the x-ray field size in the plane of the image receptor to a size smaller than the selected portion of the image receptor such that:
(A) for spot-film devices used on fixed-SID fluoroscopic systems which are not required to, and do not provide stepless adjustment of the x-ray field, the minimum field size, at the greatest SID, does not exceed 125 square cm; or
(B) for spot-film devices used on fluoroscopic systems that have a variable SID or stepless adjustment of the field size, the minimum field size, at the greatest SID, must be containable in a square of 5 cm by 5 cm.
(d) A capability may be provided for overriding the automatic x-ray field size adjustment in case of system failure. If it is so provided, a signal visible at the fluoroscopist's position must indicate whenever the automatic x-ray field size adjustment override is engaged. Each such system failure override switch must be clearly labeled as follows: "For X-ray Field Limitation System Failure".
(e) Fluoroscopy and radiography using the fluoroscopic imaging assembly with inherently circular image receptors.
(1) For fluoroscopic equipment manufactured before June 10, 2006, other than radiation therapy simulation systems, the following applies:
(i) Neither the length nor 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 percent of the SID. The sum of the excess length and the excess width shall be no greater than 4 percent of the SID.
(ii) 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.
(2) 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 must conform with one of the following requirements:
(i) 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, 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 1.5 cm, or
(ii) 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 2 cm.
(f) Fluoroscopy and radiography using fluoroscopic imaging assembly with inherently rectangular image receptors. For x-ray systems manufactured on or after June 10, 2006, the following applies:
(1) Neither the length nor 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 percent of the SID. The sum of the excess length and the excess width must be no greater than 4 percent of the SID.
(2) 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.
(g) Override capability. If the fluoroscopic x-ray field size is adjusted automatically as the SID or image receptor size is changed, a capability may be provided for overriding the automatic adjustment in case of system failure. If it is so provided, a signal visible at the fluoroscopist's position must indicate whenever the automatic field adjustment is overridden. Each such system failure override switch must be clearly labeled as follows: "For X-Ray Field Limitation System Failure".
(h) Activation of tube. X-ray production in the fluoroscopic mode must be controlled by a device which requires continuous pressure by the operator for the entire time of any exposure. When recording serial radiographic images from the fluoroscopic image receptor, the operator must be able to terminate the x-ray exposure at any time, but means may be provided to permit completion of any single exposure of the series in process.
(i) Air kerma rates. For fluoroscopic equipment, the following requirements apply:
(1) Fluoroscopic equipment manufactured before May 19, 1995.
(i) Equipment provided with automatic exposure rate control (AERC) must not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (vice 10 R/min exposure rate) at the measurement point specified in subdivision (m), except as specified in paragraph (2) of subdivision (m) of this section.
(ii) Equipment provided without AERC must not be operable at any combination of tube potential and current that will result in an AKR in excess of 44 mGy per minute (vice 5 R/min exposure rate) at the measurement point specified in paragraph (2) of subdivision (m), except during recording of fluoroscopic images.
(iii) Equipment provided with both an AERC mode and a manual mode must not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (vice 10 R/min exposure rate) in either mode at the measurement point specified in paragraph (2) of subdivision (m), except during recording of fluoroscopic images. (iv) Equipment may be modified in accordance with this Article to comply with paragraph (2) of this subdivision. When the equipment is modified, it must bear a label indicating the date of the modification.
(2) Fluoroscopic equipment manufactured after May 19, 1995:
(i) must be equipped with AERC if operable at any combination of tube potential and current that results in an AKR greater than 44 mGy per minute (vice 5 R/min exposure rate) at the measurement point specified in paragraph (2) of subdivision (m) of this section Provision for manual selection of technique factors may be provided.
(ii) must not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (vice 10 R/min exposure rate) at the measurement point specified in paragraph (2) of subdivision (m) of this section, except as specified in in paragraph (3) of this subdivision.
(3) Exceptions.
(i) 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.
(ii) 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 after termination of the exposure. Such recording does not include images resulting from a last-image-hold feature that are not recorded.
(j) Fluoroscopy equipment with optional high-level control. When high-level control is selected and the control is activated, in which case the equipment must not be operable at any combination of tube potential and current that will result in an AKR in excess of 176 mGy per minute (vice 20 R/min exposure rate) at the measurement point specified in paragraph (2) of subdivision (m) of this section. Special means of activation of high-level controls shall be required. The high-level control must 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.
(k) With the system configured in the non-mag mode of operation for the most frequently performed fluoroscopic procedure including the grid orientation in or out and the dose adjustment selection set the same as the most common exam, the exposure rates must be measured with each of the following attenuators in the beam:
(1) 0.75 inches (19 mm) of aluminum (pediatric patient),
(2) 1.50 inches (38 mm) of aluminum (small adult patient),
(3) 1.50 inches (38 mm) of aluminum and 0.02 inches (0.5 mm) of copper (average adult patient),
(4) 1.50 inches (38 mm) of aluminum and 0.08 inches (2.0 mm) of copper (large adult patient),
(5) 1.50 inches (38 mm) of aluminum and 0.08 inches (2.0 mm) of copper and 0.12 inches (3.0 mm) of lead (for maximum fluoroscopic exposure rate only).
This report of fluoroscopic exposure rates for the most frequently performed procedure must be posted so that they are conspicuous to the operator.
(l) For all fluoroscopic x-ray systems having an Automatic Brightness system, for phantom measurements conducted in subdivision (k) paragraphs (1) through (4), simulating clinical conditions, the automatic brightness system must function according to manufacturer's specifications as to adjusting the fluoroscopic techniques of kVp and/or mA. If manufacturer's specifications are not available, the specifications must be present in the facility's QA manual. In all cases for measurements required by paragraphs (2) through (4) in subdivision (k), there must be a continuous increase in the fluoroscopic exposure rate for each step from the previous step.
(m) Entrance exposure rate limits.
(1) The fluoroscopic exposure rate when measured under the following conditions should not exceed 3 Roentgens per minute and must not exceed 5 Roentgens per minute:
(i) the controls are set to the dose rate mode used for the fluoroscopic procedure most commonly performed on that fluoroscopic unit; and
(ii) the image receptor is set to the largest field of view; and
(iii) the image receptor is at 12 inches (30 cm) above the tabletop or the over table fluoro tube is at a source to image distance normally used for an average patient; and
(iv) a patient phantom composed of 1 and 1/2 inch (3.8 cm) thickness of Type 1100 aluminum and 0.02 inch (0.5 mm) thickness of copper or an equivalent device is completely intercepting the useful beam.
(2) Measuring compliance. Compliance with paragraph (1) of subdivision (m) of this section shall be determined as follows:
(i) If the source is below the x-ray table, the AKR shall be measured at 1 cm above the tabletop or cradle.
(ii) If the source is above the x-ray table, the AKR shall be measured at 30 cm above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement.
(iii) In a C-arm type of fluoroscope, the AKR shall be measured at 30 cm 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 cm from the input surface of the fluoroscopic imaging assembly.
(iv) In a C-arm type of fluoroscope having an SID less than 45 cm, the AKR shall be measured at the minimum SSD.
(v) In a lateral type of fluoroscope, the air kerma rate shall be measured at a point 15 cm 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 cm to the centerline of the x-ray table.
(3) Exemptions. Fluoroscopic radiation therapy simulation systems are exempt from the requirements in this subdivision when used for therapy simulation purposes.
(n) Resolution tests.
(1) The spatial resolution of the fluoroscopic system must be measured using a test tool composed of a line pair (lp) plate with discreet line pair groups and a maximum lead foil thickness of 0.1 mm or an equivalent device. The test tool must be placed on a 0.75 inch (19 mm) thickness of type 1100 aluminum, large enough to completely intercept the useful beam, with the test tool 12 inches (30 cm) from the entrance surface of the image receptor assembly. If the system has variable source-to-image distance (SID), the measurement SID must not exceed 40 inches (100 cm). The image receptor of the fluoroscopic system must be operated in the 6 inches (15 cm) field of view (FOV) to conduct this test. If 6 inches (15 cm) FOV is not available, the system must be operated in the smallest FOV that exceeds the 6 inches (15 cm) FOV. The minimum spatial resolution at the center of the beam for all FOVs shall be determined by the following equation: 2 lp/mm × (6 inches (15cm)/size of FOV used) = minimum number of lp/mm.
(2) The low contrast performance of the fluoroscopic system must be capable of resolving a minimum hole size of 3 mm using a test tool composed of a 1.0 mm aluminum sheet with two sets of four holes of dimension 1.0, 3.0, 5.0 and 7.0 mm and a phantom composed of a 1 and 1/2 inch (3.8 cm) thickness of Type 1100 aluminum large enough to completely intercept the useful beam or an equivalent device. The test tool must be 12 inches (30 cm) from the entrance surface of the image receptor assembly. The image receptor of the fluoroscopic system must be operated in the 6 inches (15 cm) FOV to conduct this test. If 6 inches (15 cm) FOV is not available, the system must be operated in the smallest FOV that exceeds the 6 inches (15 cm) FOV. (3) Exemptions. For all fluoroscopic systems with an image receptor diameter of less than 6 inches, or labeled and clinically used for extremity only, the high and low contrast tests need not be conducted.
(o) Indication of potential and current. During fluoroscopy and cinefluorography, x- ray tube potential and current must be continuously indicated. Deviation of x-ray tube potential and current from the indicated value must not exceed the maximum deviation as stated by the manufacturer.
(p) Source-skin distance.
(1) Means must 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 or interventional applications that would be impractical at the source-skin distances specified in this paragraph, 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 must be provided to limit the source-skin distance to not less than 19 cm. Such systems must be labeled for extremity use only. In addition, for those systems intended for specific surgical or interventional applications that would be impractical at the source-skin distance specified in this paragraph, provisions may be made for operation at shorter source-skin distances but in no case less than 10 cm.
(q) Fluoroscopic irradiation time, display, and signal.
(1) Fluoroscopic equipment manufactured before June 10, 2006:
(i) Must be provided with means to preset the cumulative irradiation time of the fluoroscopic tube. The maximum cumulative time of the timing device must not exceed 5 minutes without resetting. A signal audible to the fluoroscopist must indicate the completion of any preset cumulative irradiation time. Such signal must continue to sound while x-rays are produced until the timing device is reset. Fluoroscopic equipment may be modified in accordance with 21 C.F.R. § 1020.30(q) to comply with the requirements of this paragraph.
(ii) As an alternative to the requirements of this paragraph, 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.
(2) For x-ray controls manufactured on or after June 10, 2006, there must be provided for each fluoroscopic tube a display of the fluoroscopic irradiation time at the fluoroscopist's working position. This display must function independently of the audible signal described in this subsection. The following requirements apply:
(i) When the x-ray tube is activated, the fluoroscopic irradiation time in minutes and tenths of minutes must be continuously displayed and updated at least once every 6 seconds.
(ii) The fluoroscopic irradiation time must also be displayed within 6 seconds of termination of an exposure and remain displayed until reset.
(iii) Means shall be provided to reset the display to zero prior to the beginning of a new examination or procedure. A signal audible to the fluoroscopist must sound for each passage of 5 minutes of fluoroscopic irradiation time during an examination or procedure. The signal must sound until manually reset or, if automatically reset, for at least 2 seconds.
(r) Display of last-image-hold (LIH).
(1) Fluoroscopic equipment manufactured on or after June 10, 2006, must be equipped with means to display LIH image following termination of the fluoroscopic exposure.
(i) For an LIH image obtained by retaining pre-termination fluoroscopic images, if the number of images and method of combining images are selectable by the user, the selection must be indicated prior to initiation of the fluoroscopic exposure.
(ii) For an LIH image obtained by initiating a separate radiographic- like exposure at the termination of fluoroscopic imaging, the technique factors for the LIH image must be selectable prior to the fluoroscopic exposure, and the combination selected must be indicated prior to initiation of the fluoroscopic exposure.
(iii) Means must be provided to clearly indicate to the user whether a displayed image is the LIH radiograph or fluoroscopy. Display of the LIH radiograph must be replaced by the fluoroscopic image concurrently with re-initiation of fluoroscopic exposure, unless separate displays are provided for the LIH radiograph and fluoroscopic images.
(s) Displays of values of AKR and cumulative air kerma. Fluoroscopic equipment manufactured on or after June 10, 2006, must display at the fluoroscopist's working position the AKR and cumulative air kerma. The following requirements apply for each x-ray tube used during an examination or procedure:
(1) When the x-ray tube is activated and the number of images produced per unit time is greater than 6 images per second, the AKR in mGy/min must be continuously displayed and continually updated.
(2) The cumulative air kerma in units of mGy must be displayed either within 5 seconds of termination of an exposure or displayed continuously and regularly updated.
(3) The display of the AKR must be clearly distinguishable from the display of the cumulative air kerma.
(4) The AKR and cumulative air kerma must represent the value for conditions of free-in-air irradiation at one of the following reference locations specified according to the type of fluoroscope.
(i) For fluoroscopes with x-ray source below the x-ray table, x-ray source above the table, or of lateral type, the reference location must be the respective locations specified in subparagraphs (i), (ii) or (v) of paragraph (2) of subdivision (m) of this section.
(ii) For C-arm fluoroscopes, the reference location must be 15 cm from the isocenter toward the x-ray source along the beam axis. Alternatively, the reference location must be at a point specified by the manufacturer to represent the location of the intersection of the x-ray beam with the patient's skin.
(iii) Means must be provided to reset to zero the display of cumulative air kerma prior to the commencement of a new examination or procedure.
(iv) The displayed AKR and cumulative air kerma must not deviate from the actual values by more than ±35 percent over the range of 6 mGy/min and 100 mGy to the maximum indication of AKR and cumulative air kerma, respectively. Compliance shall be determined with an irradiation time greater than 3 seconds.
(t) Protection from scatter radiation.
(1) For stationary fluoroscopic systems, ancillary shielding, such as drapes, self-supporting curtains, or viewing shields, must be available and used as supplemental protection for all individuals other than the patient in the room during a fluoroscopy procedure.
(2) Where sterile fields or special procedures prohibit the use of normal protective barriers or drapes, all of the following conditions must be met:
(i) shielding required under paragraph (1) of this subdivision must be maintained to the degree possible under the clinical conditions.
(ii) all persons, except the patient, in the room where fluoroscopy is performed must wear protective aprons that provide a lead equivalent shielding of at least 0.25 mm, except if such persons are protected by movable lead shields of 0.25 mm lead equivalent.
(iii) Operating and safety procedures must reflect the above conditions, and fluoroscopy personnel must exhibit awareness of situations requiring the use or non-use of the protective drapes.
(u) Operator qualifications.
(1) In addition to the applicable requirements of this Article, the operation of a fluoroscopic x-ray system for clinical purposes must be limited to:
(i) a licensed practitioner working within his or her scope of practice; and
(ii) a medical resident or radiologic technology student, in training, and only under the direct personal supervision of the licensed practitioner meeting the conditions of subparagraph (i) of this paragraph (1).
(2) All persons operating, or supervising the operation of, fluoroscopy systems for clinical use must have completed appropriate training. Effective July 1, 2021, the registrant must ensure that prior to performing fluoroscopy procedures, each person operating, or supervising the operation of, fluoroscopy systems completed the training required in this paragraph. The training topics must include:
(i) basic properties of radiation;
(ii) biological effects of x-ray;
(iii) radiation protection methods for patients and staff;
(iv) units of measurement and dose, including DAP (dose-area product) values & air kerma;
(v) factors affecting fluoroscopic outputs;
(vi) high level control options;
(vii) dose management including dose reduction techniques, monitoring, and recording;
(viii) principles and operation of the specific fluoroscopic x-ray system to be used;
(ix) fluoroscopic and fluorographic outputs of each mode of operation on the system to be used clinically; and
(x) all applicable requirements of this Article.
(3) All persons operating, or supervising the operation of, fluoroscopy systems during clinical FGI procedures must have completed a minimum of 8 hours of training. Effective July 1, 2021, the registrant must ensure that prior to performing fluoroscopy procedures each person operating, or supervising the operation of, fluoroscopy systems completed the training required in this paragraph. The topics must include:
(i) the topics provided in 24 RCNY Health Code § 175.53(u)(2);
(ii) methods to reduce patient dose using advanced imaging and recording features;
(iii) procedures for recording pertinent data specified in subdivision (x) of this section.
(iv) a minimum of one hour of hands-on fluoroscopic machine training demonstrating application of topics required in this subdivision.
(4) The training required by paragraph (3) of this subdivision must be provided by a QMP or another individual approved by the Department.
(5) The registrant must either provide a minimum of 2 hours in-service training every 2 years for all individuals operating or supervising the operation of fluoroscopy systems during clinical FGI procedures, or require evidence of continuing medical education meeting the conditions of this subdivision.
(6) Documentation pertaining to the requirements of this section must be maintained for review for 5 years.
(v) Equipment operation.
(1) All fluoroscopic images must be viewed, directly or indirectly, and interpreted by a professional practitioner of the healing arts.
(2) Overhead fluoroscopy must not be used as a positioning tool for general purpose radiographic examinations.
(3) Operators must be competent in the standard operating procedures of the unit in use, including the use of available dose-saving features, and the relative radiation output rates of the various modes of operation.
(4) Procedure planning for fluoroscopic procedures on pregnant patients must include feasible modifications to minimize the dose to the conceptus.
(5) The facility must establish a written policy regarding patient dose management in fluoroscopically guided procedures in conformance with the ACR-AAPM Technical Standard for Management of the Use of Radiation in Fluoroscopic Procedures (ACR Resolution 44 - 2013), NCRP Report 168, or successor or equivalent standard. (6) Fluoroscopic systems that fail to comply with subdivisions (l) and (n) of this section must not be used for patient fluoroscopy. The failure shall be determined by the QMP report to the facility conducted as part of the facility's routine QA program testing and non-compliance with 24 RCNY Health Code Article 175 requirements so noted in the QMPs' reports.
(w) Additional requirements for facilities performing fluoroscopically-guided interventional (FGI) procedures.
(1) A registrant utilizing FGI procedures must establish a Radiation Protocol Committee (RPC) in accordance with the following:
(i) the registrant may establish a system-wide committee if the registrant has more than one site.
(ii) if the registrant has already established a radiation safety committee, the requirements of this subsection may be delegated to that committee if the members meet the requirements of paragraph (5) of this subdivision.
(2) A quorum of the RPC must meet as often as necessary, but at intervals not to exceed 12 months.
(3) Record of RPC. A record of each RPC meeting must include the date, names of individuals in attendance, minutes of the meeting, and any actions taken. The registrant must maintain the record for inspection by the Department.
(4) Provide an annual report to the radiation safety committee or radiation safety officer, in the absence of a radiation safety committee,
(5) RPC Members. Members must include but not be limited to the following individuals:
(i) a supervising physician of the healing arts who meets the requirements in subdivision (u) of this section;
(ii) a QMP;
(iii) the lead technologist or a senior technologist; and
(iv) other individuals as deemed necessary by the registrant.
(6) Establish and implement FGI procedure protocols.
(i) The RPC must establish and implement written protocols, or protocols documented in an electronic report system, that include but are not limited to the following:
(A) identification of individuals who are authorized to use fluoroscopic systems for interventional purposes.
(B) a method to be used to monitor patient radiation dose during FGI.
(C) SRDL values following nationally recognized standards,
(D) actions to be taken for cases when a SRDL is exceeded which may include patient follow-up.
(E) a review of the established protocols at an interval not to exceed 12 months.
(ii) A record of each RPC protocol must be maintained for inspection by the Department. If the RPC revises a protocol, documentation must be maintained that includes the justification for the revision and the previous protocol for inspection by the Department.
(7) Procedures for maintaining records.
(i) A record of radiation output information must be maintained so the radiation dose to the skin may be estimated in accordance with established protocols. The dose estimation methodology must be in written document and available for review during periodic department inspections. The record must include the following:
(A) patient identification;
(B) type and date of examination;
(C) identification of the fluoroscopic system used; and
(D) peak skin dose, cumulative air kerma or dose area product used if the information is available on the fluoroscopic system.
(E) if the peak skin dose, cumulative air kerma or dose area product are not displayed on the fluoroscopic system, records must include other information necessary to estimate the radiation dose to the skin in accordance with established protocol or the following as necessary:
a. fluoroscopic mode, such as, high-level or pulsed mode of operation;
b. cumulative fluoroscopic exposure time; and
c. number of films or recorded exposures.
(ii) The registrant must maintain records required by this subparagraph for inspection by the Department for 5 years.
(Added City Record 4/24/2019, eff. 5/24/2019)
(a) Applicability. The requirements of this section apply to all facilities which produce, process or interpret mammograms, including breast tomosynthesis, for screening or diagnostic purposes ("mammography facility") and are in addition to, and not in substitution for, other requirements of this Article.
(b) Requirement for certification.
(1) Except for facilities holding provisional certificates as described in paragraph (2) of this subdivision, each mammography facility must have received a certificate indicating approval by the U.S. Food and Drug Administration (FDA) to provide screening and diagnostic mammography services pursuant to 21 C.F.R. § 900.11, or any successor law or regulation.
(2) A provisional certificate issued pursuant to 21 C.F.R. § 900.11, or any successor law or regulation, will be accepted in lieu of the certificate required by paragraph (1) of this subdivision for a period of no longer than 6 months from the date of issuance plus one 90 day extension.
(c) Revocation of accreditation and accrediting body approval.
(1) If a facility's accreditation is revoked by an accrediting body (as defined in 21 C.F.R. § 900.2), the facility's certificate (as defined in 21 C.F.R. § 900.2) shall remain in effect until such time as determined by the FDA or other certifying body on a case-by-case basis after an investigation into the reasons for the revocation. If the FDA or other certifying body determines that the revocation was justified by violations of applicable quality standards, the FDA or other certifying body will suspend or revoke the facility's certificate or require the submission and implementation of a corrective action plan, whichever action will protect the public health in the least burdensome way.
(2) If the approval of an accrediting body is revoked by FDA, the certificates of the facilities accredited by such body shall remain in effect for a period of ) year after the date of such revocation subject to FDA's determination that the facility is continuing to perform mammography of acceptable quality. The facility must obtain accreditation from an approved accrediting body within 1 year of the date of revocation.
(d) Breast stereotactic x-ray. Breast stereotactic x-ray units dedicated to breast biopsy procedures are exempt from subdivisions (b) and (c) of this section. Each facility must at a minimum follow testing guidelines recommended by the American College of Radiology (ACR), or follow manufacturer recommended testing at the frequency specified. At least annually, each facility must have a QMP conduct an annual assessment of each breast stereotactic x-ray unit. The latter assessment must be in the form of a report submitted to the facility and all reported non-compliance items must be corrected within 30 days.
(Added City Record 4/24/2019, eff. 5/24/2019)
Except for dental registrants possessing cone beam computed tomography, each facility utilizing computed tomography equipment must comply with the requirements of this section.
(a) CT x-ray system equipment requirements.
(1) Each control panel and gantry of a CT x-ray system must include visual signals that indicate to the operator of the CT x-ray system whenever x-rays are being produced and when x-ray production is terminated, and, if applicable, whether the shutter is open or closed.
(2) Each CT x-ray system must be equipped with a control that allows the operator of the CT x-ray system to terminate the x-ray exposure at any time during a scan, or series of scans, when the exposure time is greater than one-half second duration.
(3) Each CT x- ray system must be designed such that the CT conditions of operation to be used during a scan or a scan sequence are indicated prior to the initiation of a scan or a scan sequence.
(4) Each CT x-ray system must include a clearly and conspicuously labeled emergency shutoff button or switch.
(5) Premature termination of the x-ray exposure by the operator must require resetting of the CT conditions of operation by the operator prior to the initiation of another scan.
(b) Patient communication and viewing requirements.
(1) Each CT x-ray system must be equipped to allow two-way aural communication between the patient and the operator at the control panel.
(2) Each CT x-ray system must be equipped with windows, mirrors, closed- circuit television, or an equivalent to permit continuous visual observation of the patient during CT scanning by the CT operator from the control panel.
(3) When the primary viewing system is by electronic means, an alternate viewing system (which may be electronic) must be available for if the primary viewing system fails.
(c) Determination of the CT unit radiation output.
(1) Each registrant must ensure that the measurement of the radiation output of each CT x-ray system that it operates is performed by, or under the direction of, a QMP and the output measurement must be conducted following the guidelines of the facility's accreditation as to methodology and as to setting scan techniques and CT unit technique settings.
(2) Each registrant must maintain and make available for review by the Department, on the premises of its radiation installation where a CT x-ray system is located, written procedures for the appropriate output measurement of the CT x-ray system.
(3) After initial installation, the CT x-ray system radiation output must be determined prior to its use on human beings and re-measured at least every 12 months thereafter. Any change or replacement of components of a CT x-ray system which could cause a change in the radiation output will require a re-measurement within 30 days of component installation under the supervision of a QMP operating within their scope of practice. If the accreditation body does not dictate the criteria for re-measurement based upon CT component replacement, then the facility must establish these criteria in conjunction with the QMP and CT service engineer, including the list of components that dictate a re-measurement, and this protocol must be documented in the facility's QA Manual.
(4) The measurement of the radiation output of a CT x-ray system must be performed with a calibrated dosimetry system. This system must have been calibrated either by the National Institute of Standards and Technology (NIST) or traceable to NIST or equivalent standards organization. The calibration must have been performed within the previous 12 months and after any servicing that might have affected system calibration,
(5) The CT dosimetry phantoms must meet the following specifications and conditions of use:
(i) any effects on the doses measured because of the removal of phantom material to accommodate dosimeters must be accounted for through appropriate corrections to the reported data or included in the statement of maximum deviation for the values obtained using the phantom; and
(ii) all dose measurements must be performed with the CT dosimetry phantom simulating an adult abdomen or adult head placed on the patient couch or support device without additional attenuation materials present.
(iii) the requirements of subparagraphs (i) and (ii) of this paragraph can also be met by using an alternative method of radiation measurement and calculation published in the peer-reviewed scientific literature and acceptable to the Department.
(6) Records of radiation output determinations performed must be maintained for 3 years at the radiation installation where the CT is located.
(d) Quality assurance testing.
(1) Each registrant possessing one or more CT units shall be deemed a large facility.
(2) Regardless of the number of patient exams conducted per year all Quality Assurance (QA) tests for existing x-ray equipment on site must be done on a frequency for a large facility. As such, each registrant must have a QA committee that meets at least semi-annually and such committee must be comprised of the medical professionals associated with the registrant's facility, including the QMP or a representative conducting the accreditation for the facility, the Radiation Safety Officer for the facility, and whatever additional facility titles that the accreditation body mandates to be present for such meetings.
(3) Each registrant must maintain a QA manual that contains written procedures for all testing and meet the requirements of the facility's accreditation body for maintaining a QA program as to what QA must be done and their mandated testing frequency. The CT Quality Assurance procedures must have been developed under the direction of a QMP and radiologist and be approved by the registrant's QA committee.
(4) The QA procedures must incorporate the use of one or more phantoms approved by the facility's accreditation body and must be imaged according to the accreditation body's recommendations. If the accreditation body does not provides tolerances for daily CT QA tests, then the facility must follow the manufacturer's specifications for daily CT QA tests and utilization of the manufacturer's phantom for such daily testing. The QA testing of the phantom must have the capability of providing an indication of contrast scale, noise, the resolution capability of the system for low and high contrast objects, and measuring the mean CT Number for water or other reference material and uniformity. All of the aforementioned image quality parameters must be evaluated at least semi-annually by a QMP and presented to the QA Committee for their review and approval.
(5) Written records of the QA checks performed by the registrant must be maintained for review by the Department for at least 5 years.
(6) QA checks must include the following:
(i) images obtained from x-ray scanning of the CT phantom pursuant to 24 RCNY Health Code § 175.55(d)(4) must be retained as electronic copies stored within the CT x-ray system or stored in the facility's Picture Archiving and Communication (PACS) system, if these images are available based on the CT system.
(ii) dose assessment for the most common CT examinations that are performed on the system for which reference levels have been published by the American College of Radiology (ACR), the American Association of Physicists in Medicine (AAPM) or the National Council on Radiation Protection and Measurements (NCRP) for pediatric head, pediatric abdomen, adult head and adult abdomen.
(iii) for brain perfusion studies clinically conducted at the registrant's facility, the registrant must have on an annual basis the clinical dose measured by a QMP and an annual evaluation and approval of the clinical protocols for such brain perfusion studies by the registrant's Radiation Protocol Committee (RPC), or Radiation Safety Committee (RSC), if the RSC assumes the responsibilities of the RPC. The facility must investigate and document the clinical necessity of brain perfusion CTDIvol doses greater than 100 rads (1 Gray) or whatever guidance dose is so stated in the ACR-ASNR-SPR Practice Parameters for the Performance of CT Perfusion in Neurological Imaging (Amended 2014) or superseding documents.
(iv) for each CT unit possessing dose adjustment software features for dose adjustment in clinical patient scans:
(A) the facility must conduct measurements to determine that the dose adjustment software is functioning as the manufacturer specified to adjust the CT imaging techniques so as to maintain image quality.
(B) this must be conducted at least annually or whenever there is a software upgrade or change to the dose adjustment software of the CT software.
(C) for verification testing as required by clause (A) of this subparagraph (iv) of paragraph (6) of this subdivision, manufacturer test results with documentation and formal report shall be acceptable to verify compliance.
(7) For CT units used for treatment planning simulation, the registrant must conduct the following QA testing, in addition to daily QA tests mandated by the accreditation agency, if the site is accredited:
(i) daily measurements to verify that image reconstruction dimensions or scaling accuracy are accurate to manufacturer's tolerances.
(ii) daily verification of the CT number uniformity for the manufacturer's water phantom and verify compliance with the manufacturer's tolerances. In this context, CT number uniformity must be conducted for the four quadrants of the water phantom image and compliance shall be determined by comparison between the outer four quadrants and the center of the water phantom as per manufacturer's tolerances.
(iii) measure each month the CT number uniformity for a variety of materials with densities above and below that of water and verify compliance with the accreditation body standards or manufacturer specifications.
(iv) the registrant can follow the accreditation body's guidelines for the conduct of such measurements and tolerances for such, but the frequency of conduct must be as stated in subparagraphs (i) through (iii) of this paragraph.
(e) Operating procedures and policies.
(1) All diagnostic CT and CBCT units for human use must be accredited by an accrediting organization recognized by the Department. This requirement does not apply to CBCT units used at dental facilities and to CT units used solely for simulation of patients for radiation therapy.
(i) Effective January 1, 2021, new registrants must be accredited but must demonstrate that they have initiated the accreditation process within 90 days of the start of operations.
(ii) Registrants, possessing CT units that have been notified by accrediting agencies that their CT units do not meet minimum standards to be accredited, must notify the Department within 30 days of such notice.
(iii) A facility performing CT that has an existing accreditation revoked, repealed, or otherwise terminated for any reason, must report such occurrence to the Department within 30 days.
(2) The CT x-ray system must not be operated on a human being except by a physician or by a licensed radiologic technologist who has been specifically trained in the operation of the CT system. To meet compliance with this section, each facility must maintain documentation that each physician or LRT operator of the facility's CT units have received training on the specific manufacturer model that the facility possesses.
(3) The registrant must ensure that each CT x-ray system has a radiation protection survey for assessment of exposure to persons in controlled and non-controlled areas made at the time of installation. Any change in the installation that compromises the original integrity of the facility's shielding and installation of a new CT unit shall require an additional radiation protection survey to verify compliance with Article standards for radiation protection doses to the public and radiation workers.
(4) Each CT x-ray system must have available at the control panel the operation and output determination of the CT x-ray system which must include:
(i) dates of the latest output determination and QA checks and the location within the facility where the results of those tests may be obtained;
(ii) instructions on the use of the CT image quality phantoms including a schedule of QA tests that are appropriate for the system as determined by the manufacturer, allowable variations for the indicated parameters.
(5) For each CT scanner in a facility, a current set of default protocols are available at the control panel (either electronically or as a document) which specifies for each routine examination the CT conditions of operation and the slice thickness, spacing between slices or pitch. The default protocols need not be the same as the clinically used scan protocols at the facility, but the clinically used protocols must be derived from the default protocols.
(6) If the QA testing on the CT x-ray system identifies that a system operating parameter has exceeded a tolerance as specified in the Quality Assurance manual, use of the CT x-ray system on patients must be limited to those exceptions permitted by established written instructions of the licensed QMP or radiologist. Upon completion of corrective action, the QA testing must be repeated to verify that the system is back within tolerance.
(7) All clinical CT scans must be free of any and all imaging artifacts that the CT facility discovers upon daily QA phantom testing. Upon discovery of any and all imaging artifacts by way of daily QA phantoms testing, the facility must cease clinical scans until corrective action has removed such artifacts being present in clinical scans, exception for all patient CT scans conducted on emergency cases such as in hospital emergency rooms or hospital trauma centers. All corrective actions must be documented by the registrant for review by the Department.
(8) Effective July 1, 2020, each registrant performing CT scans on human beings must ensure that for each scan, the radiation dose delivered by the scanner to a reference phantom or the dose received by the patient or other dose metric is saved and recorded. The dose delivered must be recorded as Computed Tomography Dose Index volume (CTDIvol), dose length product (DLP) or other dosimetry metric published in the peer reviewed scientific literature and acceptable to the Department.
(9) The displayed dose must be verified on an annual basis by or under the supervision of a QMP to ensure that the equipment manufacturer's displayed dose is within 20percent of the measured dose. To accomplish the latter, a phantom must be used for this measurement.
(10) Each registrant that performs CT scans on human beings must establish and implement a policy and a procedure to ensure that a request for a CT scan originates from a licensed physician or other authorized professional practitioner familiar with the patient's clinical condition. The request must include sufficient information to demonstrate the medical indication for the CT examination and allow for the proper performance and interpretation of the CT scan.
(11) Each facility must maintain a patient logbook of all patients undergoing CT exams at the facility. The logbook must contain the following information:
(i) patient identification information,
(ii) CT scans performed along with the imaging parameters,
(iii) the CT manufacturer's patient dose assessment, and
(iv) whether the study was conducted with contrast media.
(v) The logbook can be in electronic format provided all information is readily available to the Department during periodic inspections.
(f) CT Radiation Protocol Committee (RPC).
(1) The registrant must develop and maintain a CT RPC, or must allow its Radiation Safety Committee to assume such responsibility. Members of the RPC must include but not be limited to the:
(i) lead CT radiologist;
(ii) lead CT technologist;
(iii) QMP; and
(iv) other individuals as deemed necessary by the registrant (e.g., Radiation Safety Officer, Chief Medical or Administrative Officer, Radiology Department Administrator/Manager).
(2) The RPC must:
(i) review existing CT protocols along with the evaluation and implementation of new and innovative technologies that can improve image quality and lower patient dose in comparison with the older protocol.
(ii) review the capabilities of the individual CT scanner to ensure maximum performance is achieved.
(iii) determine and review the protocols used frequently or which could result in significant doses. This review must include acquisition and reconstruction parameters and radiation dose. At a minimum, the facility must review the following clinical protocols, if performed, at intervals at least every 12 months:
(A) Pediatric Head;
(B) Pediatric Abdomen;
(C) Adult Head;
(D) Adult Abdomen;
(E) Adult Chest;
(F) Brain Perfusion.
(iv) establish and implement written protocols, or protocols documented in an electronic reporting system, that include but are not limited to the following:
(A) a method to be used to monitor the CT radiation output.
(B) a standardized protocol naming policy.
(C) an alert dose value for CT procedures reviewed in clause (iii) of this paragraph must be established by the QMP.
(D) actions to be taken for cases when the alert dose value was exceeded, which may include patient follow-up.
(E) a process determining who has access and authority to make changes to the protocol management systems, including a method to prevent inadvertent or unauthorized modifications to a CT protocol.
(v) if CT fluoroscopy is performed, the RPC must establish and implement operating procedures and training designed to minimize patient and occupational radiation exposure.
(vi) provide an annual report to the radiation safety committee or radiation safety officer, in the absence of a radiation safety committee,
(vii) At a minimum the RPC members must meet as often as necessary to conduct business but at intervals not to exceed 12 months.
(viii) A record of each RPC meeting must be maintained. The record must include the date, names of individuals in attendance, minutes of the meeting, and any action taken.
(g) PET CT and SPECT CT systems. Registrants of CT systems used solely to calculate attenuation coefficients in nuclear medicine studies are exempt from the accreditation and quality assurance requirements of subdivisions (c) through (f) of this section. The registrant must follow the manufacturer's recommendations for the quality assurance tests to be conducted at the manufacturer's recommended frequency.
(h) CT and CBCT units utilized in podiatry and veterinary offices. CT systems, including CBCT systems, solely used for podiatry imaging or non-human imaging must meet the requirements of radiation protection surveys as indicated in 24 RCNY Health Code § 175.16, and are otherwise exempt from the accreditation and quality assurance requirements of subdivisions (c) through (f) of this section. Facilities must follow the manufacturer recommended testing protocols and frequency as stated in the manufacturer's manual, and if any tests are shown to exceed manufacturer tolerances, the registrant must complete all required corrective actions within 30 days of such test.
(Added City Record 4/24/2019, eff. 5/24/2019)
(a) Administrative controls. The registrant must ensure that the requirements of this Article are met in the operation of the therapeutic radiation machine that is registered with the Department pursuant to 24 RCNY Health Code § 175.41.
(b) A therapeutic radiation machine that does not meet the provisions of this Article shall not be used for irradiation of patients.
(c) Authorized users. The authorized user of any therapeutic radiation machine must be a physician who:
(1) is certified in:
(i) radiation oncology or therapeutic radiology by the American Board of Radiology or Radiology (combined diagnostic and therapeutic radiology program) by the American Board of Radiology prior to 1976; or
(ii) radiation oncology by the American Osteopathic Board of Radiology; or
(iii) radiology, with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or
(iv) therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or
(v) radiation oncology by the National Board of Physicians and Surgeons; or
(2) is in the active practice of therapeutic radiology, and has completed 200 hours of instruction in basic radiation techniques applicable to the use of an external beam radiation therapy unit, 500 hours of supervised work experience, and a minimum of 3 years of supervised clinical experience.
(i) To satisfy the requirement for instruction in this paragraph, classroom and laboratory training must include:
(A) radiation physics and instrumentation;
(B) radiation protection;
(C) mathematics pertaining to the use and measurement of ionization radiation; and
(D) radiation biology.
(ii) To satisfy the requirement for supervised work experience in this paragraph, training must be under the supervision of an authorized user and must include:
(A) review of the full calibration measurements and periodic quality assurance checks;
(B) evaluation of prepared treatment plans and calculation of treatment times/patient treatment settings;
(C) use of administrative controls to prevent medical events;
(D) implementing emergency procedures to be followed in the event of the abnormal operation of an external beam radiation therapy unit or console; and
(E) checking and using radiation survey meters.
(iii) To satisfy the requirement for a period of supervised clinical experience in this paragraph, training must include 1 year in a formal training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association, and an additional 2 years of clinical experience in therapeutic radiology under the supervision of an authorized user. The supervised clinical experience must include:
(A) examining individuals and reviewing their case histories to determine their suitability for external beam radiation therapy treatment, and any limitations/contraindications;
(B) selecting proper dose and how it is to be administered;
(C) calculating the therapeutic radiation machine doses and collaborating with the authorized user in the review of patients' progress and consideration of the need to modify originally prescribed doses or treatment plans as warranted by patients' reaction to radiation; and
(D) post-administration follow-up and review of case histories.
(3) For certain therapeutic modalities, such as proton, neutron, carbon, helium or any other heavy ion therapy, authorized users must document training and experience together with the specific modality. The training must include device operation, safety procedures and clinical use of the therapy unit. This training requirement may be satisfied by satisfactory completion of a training program provided by the particular therapy unit vendor or by receiving training supervised by another authorized user or QMP, who is authorized for the use of such therapy unit modality.
(4) Notwithstanding the other requirements of this section, the registrant for any therapeutic radiation machine may also submit the training of the prospective authorized user physician for Department review on a case-by-case basis.
(5) A physician shall not act as an authorized user for any therapeutic radiation machine until such time as said physician's training has been reviewed and approved by the Department.
(d) Qualifications of operators.
(1) Any person, other than a professional practitioner, who operates a therapeutic radiation machine for medical use shall be a licensed and registered radiation therapist, or a student currently enrolled in an approved program of study in radiation therapy technology and operating under the direct supervision of a professional practitioner or licensed radiation therapist.
(2) The names and training of all personnel currently operating a therapeutic radiation machine must be kept on file at the facility. Information on former operators must 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.
(e) Written safety procedures and rules must be developed by a QMP and must be available in printed form in the control area of a therapeutic radiation machine, including any restrictions required for the safe operation of the particular therapeutic radiation machine. The operator must be able to demonstrate familiarity with these rules.
(f) Individuals must not be exposed to the useful beam except for medical therapy purposes and unless such exposure has been ordered in writing by a therapeutic radiation machine authorized user. This provision specifically prohibits deliberate exposure of an individual for training, demonstration or other non-healing-arts purposes.
(g) Visiting authorized user. Notwithstanding other provisions of this section, a registrant may permit any physician to act as a visiting authorized user under the term of the registrant's Certificate of Registration for up to 60 days per calendar year if:
(1) the visiting authorized user has the prior written permission of the registrant's management and, if the use occurs on behalf of an institution, the institution's Radiation Safety Committee (where applicable); and
(2) the visiting authorized user meets the requirements established for authorized users in subdivision (c) of this section, and
(3) the registrant maintains copies of the written permission required by paragraph (1) of this subdivision and documentation that the visiting authorized user met the requirements of paragraph (2) of this subdivision for 5 years from the date of the last visit.
(h) All individuals associated with the operation of a therapeutic radiation machine must be instructed in and must comply with the provisions of the registrant's quality assurance program. In addition to the requirements of this section, these individuals are also subject to the requirements of this Article.
(i) Information and maintenance record and associated information. The registrant must maintain the following information in a separate file or package for each therapeutic radiation machine, for inspection by the Department:
(1) report of acceptance testing;
(2) records of all surveys, calibrations, and periodic quality assurance checks of the therapeutic radiation machines required by this Article, as well as the names of persons who performed such activities;
(3) records of maintenance or modifications performed on the therapeutic radiation machine, as well as the names of persons who performed such services, and
(4) signature of person authorizing the return of the therapeutic radiation machine to clinical use after service, repair or upgrade.
(j) Records retention. All records required by this section must be retained until disposal is authorized by the Department, or unless another retention period is specifically authorized. All required records must be retained in an active file from at least the time of generation until the next Department inspection. Any required record generated prior to the last Department inspection may be microfilmed or otherwise archived as long as a complete copy of said record can be retrieved until such time as the Department authorizes final disposal.
(Added City Record 4/24/2019, eff. 5/24/2019)
(a) Radiation protection surveys.
(1) The registrant must ensure that radiation protection surveys of all new facilities, and of existing facilities not previously surveyed, are performed with an operable radiation measurement survey instrument calibrated in accordance with 24 RCNY Health Code § 175.66. The radiation protection survey must be performed by, or under the direction of, a QMP and must 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, that radiation levels in both restricted and unrestricted areas are not likely to cause personnel exposures in excess of the limits specified in this Article.
(2) In addition to the requirements of paragraph (1) of this subdivision, a radiation protection survey must also be performed prior to any subsequent medical use and:
(i) after making any change in the treatment room shielding;
(ii) after making any change in the location of the therapeutic radiation machine within the treatment room;
(iii) after relocating the therapeutic radiation machine; or
(iv) 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.
(3) The survey record must indicate all instances where the facility, in the opinion of the QMP is in violation of applicable requirements. The survey record must also include:
(i) the date of the measurements;
(ii) the reason the survey is required;
(iii) the survey instrument manufacturer's name;
(iv) model number and serial number of the therapeutic radiation machine;
(v) the beam parameters in use;
(vi) the instruments used to measure radiation levels;
(vii) a plan of the areas surrounding the treatment room that were surveyed;
(viii) the measured dose rate at several points in each area expressed in microsieverts or millirems per hour;
(ix) the calculated maximum level of radiation over a period of 1 week for each restricted and unrestricted area; and
(x) the signature of the individual responsible for conducting the survey.
(4) If the results of the surveys required by this subdivision indicate any radiation levels in excess of the respective limit specified in this Article, the registrant must lock the control in the "OFF" position and not use the unit, 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 until the registrant has received a specific exemption from the Department.
(b) Modification of radiation therapy unit or room before beginning a treatment program. If the survey required by subdivision (a) of this section indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by this Article, before beginning the treatment program, the registrant must:
(1) either equip the unit with beam direction interlocks or add additional radiation shielding to ensure compliance with this Article;
(2) perform the survey required by subdivision (a) of this section again; and
(3) include in the report required by subdivision (d) of this section, the results of the initial survey, a description of the modification made to comply with paragraph (1) of subdivision (b) of this section, and the results of the second survey; or
(4) request and receive a registration amendment under this Article that authorizes radiation levels in unrestricted areas greater than those permitted by this Article.
(c) Dosimetry equipment.
(1) The registrant must have a calibrated dosimetry system available for use. The system must 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). The calibration must have been performed within the previous 24 months and after any servicing that may have affected system calibration.
(i) For beams with energies greater than 1 MV (1 MeV), the dosimetry system must have been calibrated for Cobalt-60;
(ii) For beams with energies equal to or less than 1 MV (1 MeV), the dosimetry system must have been calibrated at an energy (energy range) appropriate for the radiation being measured.
(2) The registrant must have available for use a dosimetry system to perform quality assurance check measurements. To meet this requirement, the system may be compared with a system that has been calibrated in accordance with paragraph (1) of this subdivision. This comparison must have been performed within the previous 12 months and after each servicing that may have affected system calibration. The quality assurance check system may be the same system used to meet the requirement in paragraph (1) of this subdivision.
(3) The registrant must 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 must include:
(i) the date;
(ii) the model numbers and serial numbers of the instruments that were calibrated, inter-compared, or compared as required by paragraphs (1) and (2) of this subdivision
(iii) the correction factors that were determined;
(iv) the names of the individuals who performed the calibration, intercomparison, or comparison; and
(v) evidence that the intercomparison was performed by, or under the direct supervision and in the physical presence of, a QMP.
(d) Reports of external beam radiation therapy surveys and measurements. The registrant for any therapeutic radiation machine subject to 24 RCNY Health Code §§ 175.64 or 175.65 must furnish a copy of the records required by subdivisions (a) and (b) of this section to the Department within 30 days following completion of the action that initiated the record requirement.
(Added City Record 4/24/2019, eff. 5/24/2019)
(a) The quality assurance program must include all of the policies and procedures listed in 24 RCNY Health Code § 175.108(c). In addition, the written directive described in 24 RCNY Health Code § 175.108(c)(2)(ii) must contain the patient or human research subject's name, the type and energy of the beam, the total dose, dose per fraction, treatment site and number of fractions. The registrant must retain a copy of the written directive for 3 years.
(b) Each registrant must adopt and maintain a radiation treatment planning manual prepared by a QMP. The manual must include the calculation methods and formulas to be used at the facility. The treatment planning manual shall be part of the registrant's quality assurance program required by subdivision (a) of this section. The radiation treatment manual must be included in training given pursuant to 24 RCNY Health Code § 175.11(c) to facility staff who will participate in treatment planning. Each registrant must ensure that a QMP reviews and approves the treatment planning manual at least annually.
(c) Accreditation in radiation oncology (except superficial therapeutic x-ray units).
(1) Each registrant must have an active application with, or be accredited in radiation oncology by the American College of Radiology or the American College of Radiation Oncology or the American Society for Radiation Oncology or another accrediting organization that is equivalent as determined by the Department.
(2) The registrant must maintain a record of accreditation, including a copy of the application, all supplemental application information and all correspondence transmitted between the accrediting body and the registrant or licensee. Records must be maintained for at least 6 years.
(d) A certified registrant must make a record of, but not report, a therapeutic radiation dose when errors in computation, calibration, time of exposure, treatment geometry or equipment malfunction result in a calculated total treatment dose differing from the final prescribed total treatment dose ordered by more than 10 percent.
(e) A certified registrant must report any event resulting from intervention of a patient or human research subject in which the administration of radiation results or will result in unintended permanent functional damage to an organ or a physiological system, as determined by a physician.
(Added City Record 4/24/2019, eff. 5/24/2019)
(a) For a medical event involving therapeutic radiation machines, in addition to the requirements of 24 RCNY Health Code § 175.25, the certified registrant must provide notification of a medical event to the referring physician and also notify the individual who is the subject of the medical event no later than 24 hours after its discovery, unless the referring physician personally informs the certified registrant either that he or she will inform the individual or that, based on medical judgment, telling the individual would be harmful. The certified registrant is not required to notify the individual without first consulting the referring physician. If the referring physician or the affected individual cannot be reached within 24 hours, the certified registrant must notify the individual as soon as possible thereafter. The certified registrant must not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the medical event, because of any delay in notification. To meet the requirements of this subdivision, the notification of the individual who is the subject of the medical event may be made instead to that individual's responsible relative or guardian. If a verbal notification is made, the certified registrant must inform the individual, or appropriate responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. The certified registrant must provide such a written description if requested.
(b) Aside from the notification requirements of this section, nothing in this section affects any rights or duties of certified registrants and physicians in relation to each other, to individuals affected by the medical event, or to that individual's responsible relatives or guardians.
(c) Records of medical events. A registrant must retain a record of medical events for 3 years. The record must contain the following:
(1) the registrant's name and the names of the individuals involved;
(2) the patient identification number, if one has been assigned, of the individual who is the subject of the event;
(3) a brief description of the event; why it occurred; the effect, if any, on the individual;
(4) the actions, if any, taken or planned to prevent recurrence; and
(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.
(Added City Record 4/24/2019, eff. 5/24/2019)
This section applies to photon therapy systems not capable of operating at 500kV and above, and to electron therapy systems not capable of operating at 500 keV and above. The requirements of this section do not apply to electronic brachytherapy devices.
(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 must not exceed the value specified at the distance specified for that classification of therapeutic radiation machine, as follows:
(1) for 5-50 kV Systems, the leakage air kerma rate measured at any position 5 centimeters from the tube housing assembly must not exceed 1 mGy (100 mrad) in any one hour.
(2) for >50 and <500 kV Systems, the leakage air kerma rate measured at a distance of 1 meter from the target in any direction must not exceed 1 cGy (1 rad) in any 1 hour. This air kerma rate measurement may be averaged over areas no larger than 100 square centimeters (100 cm
2
). In addition, the air kerma rate at a distance of 5 centimeters from the surface of the tube housing assembly must not exceed 30 cGy (30 rad) per hour.
(3) For each therapeutic radiation machine, the registrant must determine, or obtain from the manufacturer, the leakage radiation existing at the positions specified in paragraphs (1) and (2) of this subdivision for the specified operating conditions. Records on leakage radiation measurements must be maintained at the installation for inspection by the Department.
(b) Permanent beam limiting devices. Permanent diaphragms or cones used for limiting the useful beam must provide at least the same degree of attenuation as required for the tube housing assembly.
(c) Adjustable or removable beam limiting devices.
(1) All adjustable or removable beam limiting devices, diaphragms, cones or blocks must not transmit more than 5 percent of the useful beam for the most penetrating beam used;
(2) When adjustable beam limiting devices are used, the position and shape of the radiation field must be indicated by a light beam.
(d) Filter system. The filter system must be so designed that:
(1) filters cannot be accidentally displaced at any possible tube orientation;
(2) for equipment installed after August 1, 1994, an interlock system prevents irradiation if the proper filter is not in place;
(3) the air kerma rate escaping from the filter slot must not exceed 1 cGy (1 rad) per hour at 1 meter under any operating conditions; and
(4) each filter must be marked as to its material of construction and its thickness.
(e) Tube immobilization.
(1) The x-ray tube must be so mounted that it cannot accidentally turn or slide with respect to the housing aperture; and
(2) the tube housing assembly must be capable of being immobilized for stationary portal treatments.
(f) Source marking. The tube housing assembly must be so marked that it is possible to determine the location of the source to within 5 millimeters and such marking must be readily accessible for use during calibration procedures.
(g) Beam block. Contact therapy tube housing assemblies must 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.
(h) Timer. A suitable irradiation control device must be provided to terminate the irradiation after a pre-set time interval.
(1) A timer with a display must be provided at the treatment control panel. The timer must have a pre-set time selector and an elapsed time or time remaining indicator;
(2) the timer must be a cumulative timer 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 must be necessary to reset the elapsed time indicator;
(3) the timer must terminate irradiation when a pre-selected time has elapsed, if any dose monitoring system present has not previously terminated irradiation;
(4) the timer must permit accurate pre-setting and determination of exposure times as short as 1 second;
(5) the timer must not permit an exposure if set at zero;
(6) the timer must 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
(7) the timer must be accurate to within 1 percent of the selected value or 1 second, whichever is greater.
(i) Control panel functions. The control panel, in addition to the displays required by other provisions in this section, must have:
(1) an indication of whether electrical power is available at the control panel and if activation of the x-ray tube is possible;
(2) an indication of whether x-rays are being produced;
(3) a means for indicating x-ray tube potential and current;
(4) the means for terminating an exposure at any time;
(5) a locking device which will prevent unauthorized use of the therapeutic radiation machine; and
(6) for therapeutic radiation machines installed after August 1, 1994, a positive display of specific filters in the beam.
(j) Multiple tubes. When a control panel may energize more than one x-ray tube:
(1) it must be possible to activate only one x-ray tube at any time;
(2) there must be an indication at the control panel identifying which x-ray tube is activated; and
(3) there must be an indication at the tube housing assembly when that tube is energized.
(k) Target-to-Skin Distance (TSD). There must be a means of determining the central axis TSD to within 1 centimeter and of reproducing this measurement to within 2 millimeters thereafter.
(l) Shutters. 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 must be attenuated by a shutter having a lead equivalency not less than that of the tube housing assembly. In addition, after the unit is at operating parameters, the shutter must be controlled by the operator from the control panel. An indication of shutter position must appear at the control panel.
(m) Low filtration x-ray tubes. Each therapeutic radiation machine equipped with a beryllium or other low-filtration window must be clearly labeled as such upon the tube housing assembly and must be provided with a permanent warning device on the control panel that is activated when no additional filtration is present, to indicate that the dose rate is very high.
(n) Facility design requirements for therapeutic radiation machines capable of operating in the range 50 kV to 500 kV. In addition to shielding adequate to meet the requirements of 24 RCNY Health Code § 175.67, the treatment room must meet the following design requirements:
(1) Aural communication. Provision must be made for continuous two-way aural communication between the patient and the operator at the control panel;
(2) Viewing systems. Provision must be made to permit continuous observation of the patient during irradiation and the viewing system must be so located that the operator can observe the patient from the control panel. The therapeutic radiation machine must not be used for patient irradiation unless at least one viewing system is operational.
(o) Additional requirements. Treatment rooms that contain a therapeutic radiation machine capable of operating above 150 kV must meet the following additional requirements:
(1) all protective barriers must be fixed except for entrance doors or beam interceptors;
(2) the control panel must be located outside the treatment room or in a totally enclosed booth, which has a ceiling, inside the room;
(3) interlocks must be provided such that all entrance doors, including doors to any interior booths, must be closed before treatment can be initiated or continued. If the radiation beam is interrupted by any door opening, it must not be possible to restore the machine to operation without closing the door and reinitiating irradiation by manual action at the control panel; and
(4) when any door referred to in paragraph (3) of this subdivision is opened while the x-ray tube is activated, the air kerma rate at a distance of 1 meter from the source must be reduced to less than 1 mGy (100 mrad) per hour.
(p) Full calibration measurements.
(1) Full calibration of a therapeutic radiation machine subject to this section must be performed by, or under the direct supervision of, a QMP:
(i) before the first medical use following installation or reinstallation of the therapeutic radiation machine;
(ii) at intervals not exceeding 1 year; and
(iii) before medical use under the following conditions:
(A) whenever quality assurance check measurements indicate that the radiation output differs by more than 5 percent from the value obtained at the last full calibration and the difference cannot be reconciled; and
(B) following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam.
(iv) Notwithstanding the requirements of subparagraphs (i) – (iii) of this paragraph:
(A) full calibration of therapeutic radiation machines with multi-energy capabilities is required only for those modes or energies that are not within their acceptable range; and
(B) if the repair, replacement or modification does not affect all energies, full calibration must 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 subparagraph (iii) of this paragraph.
(2) To satisfy the requirements of paragraph (1) of this subdivision, full calibration must include all measurements recommended for annual calibration by NCRP Report 69, "Dosimetry of X-Ray and Gamma Ray Beams for Radiation Therapy in the Energy Range 10 keV to 50 MeV" (1981) or the most current revision or successor national standard.
(3) The registrant must maintain a record of each calibration for the duration of the registration. The record must include:
(i) the date of the calibration;
(ii) the manufacturer's name, model number, and serial number for both the therapeutic radiation machine and the x-ray tube;
(iii) the model numbers and serial numbers of the instruments used to calibrate the therapeutic radiation machine; and
(iv) the signature of the QMP responsible for performing the calibration.
(q) Periodic quality assurance checks.
(1) Periodic quality assurance checks must be performed on therapeutic radiation machines subject to the requirements of this section, which are capable of operation at greater than or equal to 50 kV.
(2) To satisfy the requirement of paragraph (1) of this subdivision, quality assurance checks must meet the following requirements:
(i) the registrant must perform quality assurance checks in accordance with written procedures established by the QMP; and
(ii) the quality assurance check procedures must specify the frequency at which tests or measurements are to be performed. The quality assurance check procedures must specify that the quality assurance check must be performed during the calibration specified in paragraph (1) of subdivision (p) of this section. The acceptable tolerance must be stated for each parameter measured in the quality assurance check, when compared to the value for that parameter determined in the calibration specified in paragraph (1) of subdivision (p) of this section.
(3) The cause for a parameter exceeding a tolerance set by the QMP must be investigated and corrected before the system is used for patient irradiation;
(4) Whenever a quality assurance check indicates a significant change in the operating characteristics of a system, as specified in the QMP's quality assurance check procedures, the system must be recalibrated as required in paragraph (1) of subdivision (p) of this section;
(5) The registrant must use the dosimetry system described in 24 RCNY Health Code § 175.61(c)(2) to make the quality assurance check required in paragraph (2) of this subdivision;
(6) The registrant must have the QMP review and sign the results of each radiation output quality assurance check within 30 days of the date that the check was performed;
(7) The registrant must ensure that safety quality assurance checks of therapeutic radiation machines subject to the requirements of this section are performed at intervals not to exceed 30 days;
(8) Notwithstanding the requirements of paragraphs (6) and (7) of this subdivision, the registrant must ensure that no therapeutic radiation machine is used to administer radiation to humans unless the quality assurance checks required by paragraphs (1) and (2) of this subdivision have been performed within the 30 day period immediately prior to said administration;
(9) To satisfy the requirement of paragraph (7) of this subdivision, safety quality assurance checks must ensure proper operation of:
(i) electrical interlocks at each external beam radiation therapy room entrance;
(ii) the "BEAM-ON" and termination switches;
(iii) beam condition indicator lights on the access doors, control console, and in the radiation therapy room;
(iv) viewing systems;
(v) electrically operated treatment room doors from inside and outside the treatment room, if applicable.
(10) The registrant must maintain a record of each quality assurance check required by paragraphs (1) and (7) of this subdivision for 3 years. The record must include:
(i) the date of the quality assurance check;
(ii) the manufacturer's name, model number, and serial number of the therapeutic radiation machine;
(iii) the manufacturer's name, model number and serial number for the instrument used to measure the radiation output of the therapeutic radiation machine; and
(iv) the signature of the individual who performed the periodic quality assurance check
(r) Operating procedures.
(1) The therapeutic radiation machine must not be used for irradiation of patients unless the requirements of subdivisions (p) and (q) of this section have been met.
(2) Therapeutic radiation machines must not be left unattended unless secured pursuant to paragraph (5) of subdivision (i) of this section.
(3) When a patient must be held in position for radiation therapy, mechanical supporting or restraining devices must be used.
(4) The tube housing assembly must 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 must wear protective gloves and apron of not less than 0.25 millimeters lead equivalency at 100 kV.
(5) A copy of the current operating and emergency procedures must be maintained at the therapeutic radiation machine control console.
(6) No individual other than the patient shall be in the treatment room during exposures from therapeutic radiation machines operating above 150 kV. At energies less than or equal to 150 kV, any individual, other than the patient, in the treatment room must be protected by a barrier sufficient to meet the requirements of this Article.
(s) Possession of survey instruments. Each facility location authorized to use a therapeutic radiation machine in accordance with this section must possess appropriately calibrated portable monitoring equipment. At a minimum, such equipment must include a portable radiation measurement survey instrument capable of measuring dose rates over the range 10 µSv (1 mrem) per hour to 10 mSv (1,000 mrem) per hour. The survey instrument must be operable and calibrated in accordance with 24 RCNY Health Code § 175.66.
(Added City Record 4/24/2019, eff. 5/24/2019)
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