§ 175.53 — Fluoroscopic Equipment

§ 175.53 Fluoroscopic Equipment.

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 cm2, 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 cm2 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 cm2 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. (3) Spot-film devices. In addition to the applicable requirements of 24 RCNY Health Code §§ 175.47 and 175.48, the following requirements also apply to spot-film devices, except when the spot-film device is provided for use with a radiation therapy simulation system: (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)