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(a) All x-ray equipment must be installed and operated in accordance with the equipment manufacturer's specifications. If the registrant is required to have a QA program pursuant to 24 RCNY Health Code § 175.12(b)(1), and if the manufacturer's specifications are not available, the registrant's QMP or RSO must establish specifications for equipment use and document the specifications in the registrant's QA Manual. If the Department finds that the specifications present unacceptable tolerances, the Department shall require the registrant to utilize new specifications and shall notify the registrant of such in writing.
(b) All functional x-ray units registered by the Department shall be subject to inspection by Department staff, or by individuals directed by the Department to inspect such units, such as CRESOs.
(c) Radiation safety requirements. The registrant shall be responsible for directing the operation of the x-ray system under their administrative control and must assure that the requirements of this Article are met in the operation of the x-ray system.
(d) A current copy of 24 RCNY Health Code Article 175 must be maintained and readily accessible by the registrant either in hard copy or electronic format.
(e) Registrants required to have a QA program pursuant to 24 RCNY Health Code § 175.12(b)(1) must have a written radiation safety program as part of their QA program. The radiation safety program must include, but not be limited to, the following:
(1) that the use of ionizing radiation within its purview is performed in accordance with existing laws and regulations.
(2) that all persons are protected as required by this Article.
(3) that upon discovery of a medical event (as defined in this Article), the registrant must follow the applicable requirements of 24 RCNY Health Code § 175.25 concerning notification to the Department.
(f) If an x-ray system does not meet the provisions of this Article, then the registrant must correct such non-compliance, or initiate necessary corrective action, within 30 days of such discovery.
(g) Individuals operating the x-ray systems must meet all licensure, training and experience qualifications required by the Department.
(h) A sufficient number of protective apparel (e.g., aprons, gloves, collars) and shields must be available to provide the necessary radiation protection for all patients and personnel who are involved with x-ray operations.
(i) The registrant must use auxiliary equipment designed to minimize patient and personnel exposure commensurate with the needed diagnostic information.
(j) Neither the x-ray tube housing nor the collimating device shall be held during an exposure. Exceptions may be allowed for Department-approved devices specifically designed to be hand-held in the area of patient dental exams. The Department shall maintain a list of hand- held dental units that are approved for clinical exams in New York City, or may accept the list of such hand-held dental units as approved by New York State Department of Health, at the Department's discretion.
(k) The useful x-ray beam must be limited to the area of clinical interest. For x-ray units not utilizing PBL systems for clinical imaging and not using cones or diaphragms for beam restriction, the clinical x-ray field must be less than size of the image receptor on four of four sides of the image receptor. For all digital image receptors, the size of the clinical image must not be digitally manipulated as to render its original dimensions different from the clinical image size when the image is archived.
(l) Consideration must be given to selecting the appropriate technique and employing available dose reduction methods and technologies across all patient sizes and clinical indications. For registrants utilizing manual selection of technique settings for clinical x-ray exams, this means a technique chart that employs technique settings for thin, average and heavy patient sizes. In the case where children less than 18 years of age are radiographed, the minimal technique setting should correspond to patients of 1-years old, 5-years old and 10-years old for exams most likely to be administered, e.g., AP chest and abdomen exams. In all such cases, the Entrance Skin Exposure (ESE) must be directly or indirectly determined for all clinical techniques set. At a minimum, these technique charts along with ESEs must include:
(1) patient's (adult and pediatric, if appropriate) body part and anatomical size;
(2) technique factors;
(3) type of image receptor used;
(4) source to image receptor distance used (except for dental intraoral radiography), and
(5) position of the grid for the x-ray exam, i.e., the grid is either removed from the x-ray beam or is in the x-ray beam.
(m) A facility must have a documented procedure in place for verification of patient identity and exam to be performed, including identification of the appropriate body part.
(n) The registrant must create and make available to x-ray operators written safety procedures, including instructions for patient holding and any restrictions of the operating technique required for the safe operation of the particular x-ray system. The operator must be able to demonstrate familiarity with these procedures. Patient holding must be restricted to radiographic examinations with the exception that holding of patients shall be prohibited for all fluoroscopic exams and patient CT exams with the exception of hospital emergency rooms and hospital trauma centers.
(o) The registrant must restrict the presence of individuals in the x-ray room of the patient being examined to those required or in training for the medical procedure, or the parent or guardian of a patient while the x-ray tube is energized. Other than the patient being examined, the following applies to all individuals in the x-ray room:
(1) all persons must be positioned such that no part of the body will be struck by the useful beam unless protected by not less than 0.25 millimeter lead equivalent material;
(2) If the procedure results in secondary or scatter radiation in excess of 0.02 mSv (2 mrem) in any one hour at the position of these persons, they must be protected from the direct scatter radiation by whole body protective barriers of not less than 0.25 millimeter lead equivalent material or must be positioned so that the 0.02 mSv (2 mrem) in any one hour limit is met.
(p) Individuals must not be exposed to the useful beam except for healing arts purposes and unless such exposure has been authorized by a professional practitioner of the healing arts. This provision specifically prohibits deliberate exposure for the following purposes:
(1) exposure of an individual for training, demonstration, or other non-healing arts purposes; and
(2) exposure of an individual for the purpose of healing arts screening except as authorized by the Department.
(q) X-ray patient logbook. Each facility must maintain a written or electronic record containing the patient's name, the type of examinations, and the dates the examinations were performed for all radiographic (except dental, podiatric and veterinary exams) and fluoroscopic patient exams. The administration of contrast agents as part of the patient exam must be noted in the patient logbook to state that IV contrast was administered. All adverse effects to injected contrast agents must be reported to the NY State Health Department, as required by law.
(r) Sealing x-ray equipment. Sealing of x-ray units must be done only by the Department for x-ray units, of any type, that poses a hazard to the patient or the operator. No x- ray units sealed by the Department shall be put in use for clinical exams without the approval of the Department.
(s) Leakage radiation from the diagnostic source assembly. The leakage radiation from the diagnostic source assembly measured at a distance of 1 meter in any direction from the source must not exceed 0.88 milligray (mGy) air kerma (vice 100 milliroentgen (mR) exposure) in 1 hour when the x-ray tube is operated at its leakage technique factors. If the maximum rated peak tube potential of the tube housing assembly is greater than the maximum rated peak tube potential for the diagnostic source assembly, positive means must be provided to limit the maximum x-ray tube potential to that of the diagnostic source assembly.
(t) Technique indicators.
(1) For x-ray equipment capable of displaying technique factors, the technique factors to be used during an exposure must be indicated before the exposure begins. If automatic exposure controls are used, the technique factors which are set prior to the exposure must be indicated.
(2) The requirement of paragraph (1) of this subdivision may be met by permanent markings on equipment having fixed technique factors. Indication of technique factors must be visible from the operator's position except in the case of spot films made by the fluoroscopist.
(3) The accuracy of the technique factors for the x-ray unit (e.g., indicated kilovoltage peak (kVp), timer accuracy) must meet manufacturer specifications. In the absence of a manufacturer specification, the technique factor accuracy must be within ±10 percent.
(u) Beam quality.
(1) The half value layer (HVL) of the useful beam for a given x-ray tube potential shall not be less than the values shown in Table 1 of this subdivision. If it is necessary to determine such half-value layer at an x-ray tube potential which is not listed in Table 1, linear interpolation or extrapolation may be made. Positive means must be provided to ensure that at least the minimum filtration needed to achieve beam quality requirements is in the useful beam during each exposure. In the case of a system which is to be operated with more than one thickness of filtration, this requirement can be met by a filter interlocked with the kilovoltage selector which will prevent x-ray emissions if the minimum required filtration is not in place. In no case shall an x-ray unit failing to meet the minimum filtration standards in Table 1 conduct clinical patient exams until the x-ray unit is in compliance with Table 1.
TABLE 1*
X-Ray Tube Voltage (kilovolt peak) | ||||
Design Operating Range | Measured Operating Potential | Minimum HVL (mm in Aluminum) | ||
Specified Dental Systems 1 | Other X-Ray Systems (older) 2 | Other X-Ray Systems (newer) 3 | ||
X-Ray Tube Voltage (kilovolt peak) | ||||
Design Operating Range | Measured Operating Potential | Minimum HVL (mm in Aluminum) | ||
Specified Dental Systems 1 | Other X-Ray Systems (older) 2 | Other X-Ray Systems (newer) 3 | ||
Below 51 | 30 | 1.5 | 0.3 | 0.3 |
40 | 1.5 | 0.4 | 0.4 | |
50 | 1.5 | 0.5 | 0.5 | |
51 to 70 | 51 | 1.5 | 1.2 | 1.3 |
60 | 1.5 | 1.3 | 1.5 | |
70 | 1.5 | 1.5 | 1.8 | |
Above 70 | 71 | 2.1 | 2.1 | 2.5 |
80 | 2.3 | 2.3 | 2.9 | |
90 | 2.5 | 2.5 | 3.2 | |
100 | 2.7 | 2.7 | 3.6 | |
110 | 3.0 | 3.0 | 3.9 | |
120 | 3.2 | 3.2 | 4.3 | |
130 | 3.5 | 3.5 | 4.7 | |
140 | 3.8 | 3.8 | 5.0 | |
150 | 4.1 | 4.1 | 5.4 | |
1 Dental x-ray systems designed for use with intraoral image receptors and manufactured after December 1, 1980. 2 Dental x-ray systems designed for use with intraoral image receptors and manufactured before or on December 1,1980, and all other x-ray systems subject to this section and manufactured before June 10, 2006. 3 All x-ray systems, except dental x-ray systems designed for use with intraoral image receptors, subject to this section and manufactured on or after June 10, 2006. * Source: 21 C.F.R. § 1020.30(m) | ||||
(2) Measuring compliance. For capacitor energy storage equipment, compliance shall be determined with the maximum selectable quantity of charge per exposure.
(v) Battery charge indicator. On battery-powered generators, visual means must be provided on the control panel to indicate whether the battery is in a state of charge adequate for proper operation.
(w) Modification of certified diagnostic x-ray components and systems.
(1) Diagnostic x-ray components and systems certified in accordance with 21 C.F.R. Part 1020 must not be modified except with certified components.
(2) The owner who causes such modification must record the date and the details of the modification in the system records and maintain this information, and the modification of the x-ray system must not result in a failure to comply with this Article.
(x) Multiple tubes. Where two or more radiographic tubes are controlled by one exposure switch, the tube which has been selected must be clearly indicated prior to initiation of the exposure. Only the selected tube can be energized. This indication must be both on the x-ray control panel and at or near the tube housing assembly which has been selected.
(y) Mechanical support of tube head. The tube housing assembly supports must be adjusted such that the tube housing assembly will remain stable during an exposure unless tube housing movement is a designed function of the x-ray system.
(z) Locks. All position locking, holding, and centering devices on x-ray system components and systems must function as intended.
(aa) Maintaining compliance. Diagnostic x-ray systems and their associated components used on humans and certified pursuant to the Federal Performance Standard for Diagnostic X-Ray Systems (21 C.F.R. § 1020.30) must be maintained in compliance with applicable requirements of that standard.
(Added City Record 4/24/2019, eff. 5/24/2019)
The requirements of this section apply to all non-dental registrants using diagnostic x-ray equipment.
(a) Acceptance testing. Each registrant must have acceptance testing conducted on all radiographic x-ray units with the exception of dental, podiatric, and bone densitometer units, 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 must be 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 registrant's QMP must develop tolerances that must be used in subsequent QA testing by the registrant and must be so noted in the quality assurance manual.
(b) Control and indication of technique factors.
(1) Timers. Means must be provided to terminate the exposure at a preset time interval, a preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor.
(i) Except during serial radiography, the operator must be able to terminate the exposure at any time during an exposure of greater than one-half second. Except during panoramic dental radiography, termination of exposure must cause automatic resetting of the timer to its initial setting or to zero. It must not be possible to make an exposure when the timer is set to a zero or off position if either position is provided.
(ii) During serial radiography, 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.
(2) Automatic exposure controls. When an automatic exposure control is provided:
(i) indication must be made on the control panel when this mode of operation is selected;
(ii) when the x-ray tube potential is equal to or greater than 51 kilovolts peak (kVp), the minimum exposure time for field emission equipment rated for pulse operation must be equal to or less than a time interval equivalent to two pulses and the minimum exposure time for all other equipment must be equal to or less than 1/60 second or a time interval required to deliver 5 milliampere-seconds (mAs), whichever is greater;
(iii) either the product of peak x-ray tube potential, current, and exposure time must be limited to not more than 60 kilowatt-seconds (kWs) per exposure or the product of x-ray tube current and exposure time must be limited to not more than 600 mAs per exposure, except when the x-ray tube potential is less than 51 kVp, in which case the product of x-ray tube current and exposure time must be limited to not more than 2,000 mAs per exposure; and
(iv) a visible signal must indicate when an exposure has been terminated at the limits described in subparagraph (iii) of this paragraph, and manual resetting must be required before further automatically timed exposures can be made.
(c) Reproducibility.
(1) Coefficient of variation. For any specific combination of selected technique factors, the estimated coefficient of variation of the air kerma must be no greater than 0.05.
(2) Measuring compliance. Determination of compliance must be based on 10 consecutive measurements taken within a time period of 1 hour. Equipment manufactured after September 5, 1978, must also have all variable controls for technique factors adjusted to alternate settings and reset to the test setting after each measurement. For equipment having automatic exposure controls, compliance shall be determined with a sufficient thickness of attenuating material in the useful beam such that the technique factors can be adjusted to provide individual exposures of a minimum of 12 pulses on field emission equipment rated for pulsed operation or no less than one-tenth second per exposure on all other equipment.
(3) Alternatively, the reproducibility of any technique value may be determined by taking 5 consecutive measurements and utilizing the formula given below:
Reproducibility = (maximum measured value - minimum measured value)
Average of the measured five values
The calculated reproducibility shall be equal to ± 10 percent for compliance.
(d) Linearity. The following requirements apply for any fixed x-ray tube potential within the range of 40 percent to 100 percent of the maximum rated. In regard to paragraphs (1) through (3) in this subdivision below, measurements can be made in mR instead of mGy.
(1) Equipment having independent selection of x-ray tube current (mA). The average ratios of air kerma to the indicated milliampere-seconds product (mGy/mAs) obtained at any two consecutive tube current settings must not differ by more than 0.10 times their sum. This is: |X1 - X2 ≤ | 0.10(X1 + X2); where X1 and X2 are the average mGy/mAs values obtained at each of two consecutive mAs selector settings or at two settings differing by no more than a factor of 2 where the mAs selector provides continuous selection.
(2) Equipment having selection of x-ray tube current-exposure time product (mAs). For equipment manufactured after May 3, 1994, the average ratios of air kerma to the indicated milliampere-seconds product (mGy/mAs) obtained at any two consecutive mAs selector settings must not differ by more than 0.10 times their sum. This is: |X1 - X2 ≤ | 0.10(X1 + X2); where X1 and X2 are the average mGy/mAs values obtained at each of two consecutive mAs selector settings or at two settings differing by no more than a factor of 2 where the mAs selector provides continuous selection.
(3) Measuring compliance. Determination of compliance will be based on at least 3 exposures, made within 1 hour, at each of the two settings. These two settings may include any two focal spot sizes except where one is equal to or less than 0.45 mm and the other is greater than 0.45 mm. For purposes of this requirement, focal spot size is the focal spot size specified by the x-ray tube manufacturer.
(e) Field limitation and alignment for mobile, portable, and stationary general purpose x-ray systems. Except when spot-film devices are in service, mobile, portable, and stationary general purpose radiographic x-ray systems must meet the following requirements:
(1) Variable x-ray field limitation. A means for stepless adjustment of the size of the x-ray field must be provided. Each dimension of the minimum field size at an SID of 100 cm must be equal to or less than 5 cm.
(2) Visual definition.
(i) Means for visually defining the perimeter of the x-ray field must be provided. The total misalignment of the edges of the visually defined field with the respective edges of the x-ray field along either the length or width of the visually defined field must not exceed 2 percent of the distance from the source to the center of the visually defined field when the surface upon which it appears is perpendicular to the axis of the x-ray beam.
(ii) When a light localizer is used to define the x-ray field, it must provide an average illuminance of not less than 160 lux (15 footcandles) at 100 cm or at the maximum SID, whichever is less. The average illuminance shall be based on measurements made in the approximate center of each quadrant of the light field. Radiation therapy simulation systems are exempt from this requirement.
(iii) The edge of the light field at 100 cm or at the maximum SID, whichever is less, must have a contrast ratio, corrected for ambient lighting, of not less than 4 in the case of beam-limiting devices designed for use on stationary equipment, and a contrast ratio of not less than 3 in the case of beam-limiting devices designed for use on mobile and portable equipment. The contrast ratio is defined as I1/I2, where I1 is the illuminance 3 mm from the edge of the light field toward the center of the field; and I2 is the illuminance 3 mm from the edge of the light field away from the center of the field.
(f) Field indication and alignment on stationary general purpose x-ray equipment. Except when spot-film devices are in service, stationary general purpose x-ray systems must meet the following requirements, in addition to those prescribed in subdivision (e) of this section:
(1) Means must be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor, to align the center of the x-ray field with respect to the center of the image receptor to within 2 percent of the SID, and to indicate the SID to within 2 percent;
(2) The beam-limiting device must numerically indicate the field size in the plane of the image receptor to which it is adjusted;
(3) Indication of field size dimensions and SIDs must be specified in centimeters or inches and must be such that aperture adjustments result in x-ray field dimensions in the plane of the image receptor which correspond to those indicated by the beam-limiting device to within 2 percent of the SID when the beam axis is indicated to be perpendicular to the plane of the image receptor; and
(4) Compliance measurements will be made at each SID in common clinical use (such as SIDs of 100, 150, and 200 cm or 36, 40, 48, 72 inches) and with at least one of the commonly used image receptor dimensions (such as nominal image receptor dimensions of 13, 18, 24, 30, 35, 40, and 43 cm or 5, 7, 8, 9, 10, 11, 12, 14, and 17 inches), or at any other specific dimensions at which the beam-limiting device or its associated diagnostic x-ray system is uniquely designed to operate.
(g) Field limitation on x-ray equipment other than general purpose radiographic systems.
(1) X-ray systems designed for one image receptor size. Radiographic equipment designed for only one image receptor size at a fixed SID must be provided with means to limit the field at the plane of the image receptor to dimensions no greater than those of the image receptor, and to align the center of the x-ray field with the center of image receptor to within 2 percent of the SID, or must be provided with means to both size and align the x-ray field such that the x-ray field at the plane of the image receptor does not extend beyond the edge of the image receptor.
(2) Other x-ray systems. Radiographic systems not specifically covered in subdivisions (e) and (f) of this section, and paragraph (1) of this subdivision, which are also designed for use with extraoral image receptors and when used with an extraoral image receptor, must be provided with means to limit the x-ray field in the plane of the image receptor so that such field does not exceed each dimension of the image receptor by more than 2 percent of the SID, when the axis of the x-ray beam is perpendicular to the plane of the image receptor. In addition, means must be provided to align the center of the x-ray field with the center of the image receptor to within 2 percent of the SID, or means must be provided to both size and align the x-ray field such that the x-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor. These requirements may be met with:
(i) A system which performs in accordance with subdivisions (e) and (f) of this section or when alignment means are also provided, may be met with either;
(ii) An assortment of removable, fixed-aperture, beam-limiting devices sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Each such device must have clear and permanent markings to indicate the image receptor size and SID for which it is designed; or
(iii) A beam-limiting device having multiple fixed apertures sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Permanent, clearly legible markings must indicate the image receptor size and SID for which each aperture is designed and must indicate which aperture is in position for use.
(h) Positive beam limitation (PBL). The requirements of this subdivision apply to radiographic systems which contain PBL and which the registrant has not disabled.
(1) Field size. When a PBL system is provided, it must prevent x-ray production when:
(i) Either the length or width of the x-ray field in the plane of the image receptor differs from the corresponding image receptor dimension by more than 3 percent of the SID; or
(ii) The sum of the length and width differences stated in subparagraph (i) of this paragraph without regard to sign exceeds 4 percent of the SID.
(iii) The beam-limiting device is at an SID for which PBL is not designed for sizing.
(2) Conditions for PBL. When provided and if the registrant has not disabled it, the PBL system must function as described in subparagraph (i) of paragraph (1) of this subdivision. whenever all the following conditions are met:
(i) The image receptor is inserted into a permanently mounted cassette holder;
(ii) The image receptor length and width are less than 50 cm;
(iii) The x-ray beam axis is within ±3 degrees of vertical and the SID is 90 cm to 130 cm inclusive; or the x-ray beam axis is within ±3 degrees of horizontal and the SID is 90 cm to 205 cm inclusive;
(iv) The x-ray beam axis is perpendicular to the plane of the image receptor to within ±3 degrees; and
(v) Neither tomographic nor stereoscopic radiography is being performed.
(3) Measuring compliance. Compliance with the requirements of subparagraph (i) of paragraph (1) of this subdivision shall be determined when the equipment indicates that the beam axis is perpendicular to the plane of the image receptor and the provisions of paragraph (2) of this subdivision are met. Compliance shall be determined no sooner than 5 seconds after insertion of the image receptor.
(4) Operator initiated undersizing. The PBL system must be capable of operating such that, at the discretion of the operator, the size of the field may be made smaller than the size of the image receptor through stepless adjustment of the field size. Each dimension of the minimum field size at an SID of 100 cm must be equal to or less than 5 cm. Return to PBL function as described in paragraph (1) of this subdivision must occur automatically upon any change of image receptor size or SID.
(5) Override of PBL. A capability may be provided for overriding PBL in case of system failure and for servicing the system. This override may be for all SIDs and image receptor sizes. A key must be required for any override capability that is accessible to the operator. It must not be possible to remove the key while PBL is overridden. Each such key switch or key must be clearly and durably labeled as follows: "For X-Ray Field Limitation System Failure". The override capability is considered accessible to the operator if it is referenced in the operator's manual or in other material intended for the operator or if its location is such that the operator would consider it part of the operational controls.
(6) Disabling of PBL. A facility has the option to permanently functionally disable a PBL system. When this option is chosen, the standards for manual collimation apply.
(i) Source-skin distance. The minimum source-skin distance must not be less than 30 cm, except intraoral dental equipment regardless of clinical or veterinary use.
(j) Radiation from capacitor energy storage equipment. Radiation emitted from the x-ray tube must not exceed:
(1) an air kerma of 0.26 microGy (vice 0.03 mR exposure) in 1 minute at 5 cm from any accessible surface of the diagnostic source assembly, with the beam-limiting device fully open, the system fully charged, and the exposure switch, timer, or any discharge mechanism not activated ; and
(2) an air kerma of 0.88 mGy (vice 100 mR exposure) in one hour at 100 cm from the x-ray source, with beam-limiting device fully open, when the system is discharged through the x-ray tube either manually or automatically by use of a discharge switch or deactivation of the input power. Compliance shall be determined by measurements of the maximum air kerma per discharge multiplied by the total number of discharges in 1 hour (duty cycle).
(k) Tube stands for portable x-ray systems. Except during veterinary field operations where it is impractical to do so, a tube stand or other mechanical support must be used for portable x-ray systems, so that the x-ray tube housing assembly need not be hand-held during an exposure.
(l) Conditions of use.
(1) The x-ray image receptor used as recording medium during the x-ray examination must show visual evidence of cut-off (beam delineation) on all four sides of the x- ray image. This applies to all x-ray units using manual collimation and where no positive means are used to contain the x-ray field to the size of the image receptor. The x-ray image receptor can be film or digital image receptors.
(2) Personnel monitoring must be required for all persons operating mobile or portable x-ray equipment, except hand-held dental x-ray units.
(3) No person shall be regularly employed to hold patients during exposures nor shall such duty be performed by an individual occupationally exposed to radiation in the course of that individual's other duties. When it is necessary to immobilize the patient, mechanical supporting or immobilizing devices should be used. Written safety procedures must provide the selection criteria for the holder and protocol to be followed during the patient holding procedure.
(4) If patients must be held by an individual, that individual must be instructed in personal radiation safety and must be protected with appropriate shielding devices such as protective gloves and a protective garment of at least 0.25 mm lead equivalent. No part of the holding individual's body shall be in the useful beam. The exposure of any individual used for holding patients must be monitored.
(5) For patients who have not passed the reproductive age, gonadal shielding of not less than 0.5 mm lead equivalent must be used during radiographic procedures in which the gonads are in the useful beam, except for cases in which this would interfere with the diagnostic procedure.
(6) Pregnant women and individuals under 18 years of age must not hold patients under any conditions.
(Added City Record 4/24/2019, eff. 5/24/2019)
(a) The following specific quality assurance requirements apply to a dental facility:
(1) If using a filmless system, maintain and operate PSP and DDR systems according to manufacturer specifications.
(2) The registrant must provide initial training and annual evaluations of x-ray operators to include but not limited to: positioning of the x-ray tube, image processing, operator location during x-ray exposure, source to skin distance, radiation protection, appropriate radiographic protocol and applicable regulatory requirements. Records of training and annual evaluations must be maintained for inspection by the Department.
(b) Warning label.
(1) On systems manufactured on or before June 10, 2006, the control panel containing the main power switch must bear the following warning statement, or the warning statement in paragraph (2) of this subdivision, legible and accessible to view: "WARNING: This x-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed."
(2) On systems manufactured after June 10, 2006, the control panel containing the main power switch must bear the warning statement, legible and accessible to view: "WARNING: This x-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions and maintenance schedules are observed."
(c) Radiation exposure control. Means must be provided to initiate the radiation exposure by a deliberate action on the part of the operator, such as the depression of a switch. Radiation exposure must not be initiated without such an action.
(d) Exposure control location and operator protection. Except for units designed to be hand-held, the exposure control must allow the operator to be:
(1) behind a protective barrier at least 2 meters (6.5 feet) tall, or
(2) at least 2 meters (6.5 feet) from the tube housing assembly, outside the path of the useful x-ray beam, while making exposures.
(e) Administrative controls.
(1) Patient and image receptor holding devices must be used when the techniques permit.
(2) Except for units designed to be hand-held, the tube housing and position indicating device (PID) must not be hand-held during an exposure.
(f) Hand-held intraoral equipment. In addition to other requirements in this Article, the following applies specifically to hand-held devices:
(1) The hand-held x-ray system must be equipped with a backscatter shield of not less than 0.25 mm lead equivalent and 15.2 cm (6 inches) in diameter that is positioned as close as practicable to the distal end of the position indication device.
(2) The facility must maintain documentation that each operator has completed training as specified by the manufacturer.
(3) The facility must adopt and follow protocols provided by the manufacturer, and approved by the Department, regarding the safe operation of the device.
(4) When operating a hand-held intraoral dental radiographic unit, operators must wear a 0.25 mm lead equivalent apron.
(5) If the operator has difficulty in holding the device stationary during the exposure, the operator shall use a stand to immobilize the device.
(6) The registrant must secure the hand-held device from unauthorized removal or use.
(g) Beam-on indicators. The x-ray control must provide visual indication whenever x- rays are produced. In addition, for certified x-ray units, a signal audible to the operator must indicate that the exposure has terminated.
(h) Multiple tubes. Where two or more radiographic tubes are controlled by one exposure switch, the tube which has been selected must be clearly indicated prior to initiation of the exposure. Only the selected tube can be energized. This indication must be both on the x-ray control panel and at or near the tube housing assembly which has been selected.
(i) Mechanical support of tube head. The tube housing assembly supports must be adjusted such that the tube housing assembly will remain stable during an exposure unless tube housing movement is a designed function of the x-ray system.
(j) Battery charge indicator. On battery-powered generators, visual means must be provided on the control panel to indicate whether the battery is in a state of charge adequate for proper operation.
(k) Technique indicators.
(1) For x-ray equipment capable of displaying technique factors, the technique factors to be used during an exposure must be indicated before the exposure begins.
(2) The requirement of paragraph (1) of this subdivision may be met by permanent markings on equipment having fixed technique factors.
(l) Exposure reproducibility. For any specific combination of selected technique factors, the estimated coefficient of variation of the air kerma must be no greater than 0.05.
(m) Timers. Means must be provided to terminate the exposure at a preset time interval, a preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor.
(n) Kilovolt peak. At a minimum, the kVp must be accurate to within 10 percent on variable kVp units and within 20 percent on fixed kVp units.
(o) X-ray beam alignment.
(1) The useful x-ray beam must be limited to the area of clinical interest.
(2) Intraoral dental units.
(i) X-ray systems designed for use with an intraoral image receptor must be provided with means to limit the source-to-skin distance (SSD) to not less than 18 cm.
(ii) The x-ray field at the minimum SSD must be containable in a circle having a diameter of no more than 7 cm.
(3) Extraoral, panoramic and cephalometric units. X-ray systems designed for use with extraoral image receptors and when used with an extraoral image receptor, must be provided with means to limit the x-ray field in the plane of the image receptor so that such field does not exceed each dimension of the image receptor by more than 2 percent of the SID, when the axis of the x-ray beam is perpendicular to the plane of the image receptor. In addition, means must be provided to align the center of the x-ray field with the center of the image receptor to within 2 percent of the SID, or means must be provided to both size and align the x-ray field such that the x-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor. These requirements may be met with:
(i) An assortment of removable, fixed-aperture, beam-limiting devices sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Each such device must have clear and permanent markings to indicate the image receptor size and SID for which it is designed; or
(ii) A beam-limiting device having multiple fixed apertures sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Permanent, clearly legible markings must indicate the image receptor size and SID for which each aperture is designed and must indicate which aperture is in position for use.
(p) Beam quality. The Half Value Layer (HVL) of the useful beam for a given x-ray tube potential must not be less than the values shown in Table 1 of 24 RCNY Health Code § 175.47(u). If it is necessary to determine such half-value layer at an x-ray tube potential which is not listed in Table 1, linear interpolation or extrapolation may be made.
(q) Conditions of use.
(1) The x-ray system must always be operated in such a manner that the useful beam at the patient's skin does not exceed the requirements of paragraph (2) of subdivision (o) of this section.
(2) The operator shall position the end of the position indicating device (PID) within 1 cm (0.4 in.) of the skin of the patient, if such device is routinely used in conducting dental radiography.
(3) Time-temperature techniques or automatic processing must be used to develop pre-operative diagnostic dental x-ray films. Processing techniques must be consistent with those recommended by the x-ray film manufacturer. Sight developing of dental radiographs is prohibited except for films taken during operative procedures.
(4) Dental x-ray exposure technique factors and dental processing conditions must yield entrance skin exposure (ESE) values for the bitewing x-ray projection that are identical to or do not exceed the maximum range of ESE values for dental "D" and "E" speed film designations as published in HHS document #FDA-85-8245 (August 1985) or superseding documents. With respect to maximum ESE values for digital image receptors (are deemed to be either Computed Radiography (CR) or Digital Image Receptors (DR)), digital image receptors shall be deemed to be equivalent to "E" speed film.
(r) Facilities possessing a Cone Beam Computed Tomography (CBCT) unit.
(1) Notwithstanding anything in this Article to the contrary, dental facilities possessing a CBCT unit must develop and maintain a written quality assurance program, including a written QA manual and a written radiation safety policy and procedures manual for all CBCT dental equipment possessed by the facility.
(i) For all dental CBCT units, the registrant must establish annual QA testing of x-ray parameters sufficient to maintain patient doses and image quality consistent over time. The annual tests will evaluate, at a minimum, collimation, filtration, patient dose, accuracy and reproducibility of x-ray techniques and the operational status of x-ray safety features.
(ii) For all CBCT units, the QA tests must follow the manufacturer's recommended tests and frequency and utilize the manufacturer's QA phantom. The QA test results will be retained for review by the Department for 5 years, the facility must establish QA testing that includes, at a minimum, the manufacturer's recommended QA tests plus the additional QA tests described in subparagraph (iii) of this subdivision.
(iii) Semi-annual QA tests to determine image noise, image uniformity, reconstructed image measurement accuracy, high contrast spatial resolution of the CBCT unit.
(iv) Dental facilities possessing a CBCT unit must use a medical physicist who is a QMP in performing its QA activities.
(2) Dental facilities possessing CBCT equipment must annually determine the patient radiation dose (using direct measurement or indirect means to estimate dose) for the most common CBCT scan used at the facility as conducted by a QMP.
(3) Dental facilities possessing CBCT equipment must conduct annual QA tests to measure reproducibility of imaging parameters (kVp, exposure time and dimensions of the scan beam), reproducibility of exposure per the most common scan and beam filtration (HVL).
(4) Conditions of operation for the CBCT unit.
(ii) All operators of the CBCT must undergo training on the proper operation of the CBCT units and documentation of this training must be retained by the dental facility for review by the Department until after the next scheduled inspection is completed by the Department.
(iii) All operators must be able to communicate with and visually observe the patient during the CBCT examination from the operator's protected position.
(iv) CBCT patient exams will not be conducted solely for cosmetic purposes with no diagnostic value to the patient.
(v) The logbook for CBCT exams must contain all relevant diagnostic examination information, including but not limited to, x-ray technique, scan time, anatomical exam site and reason for examination.
(Added City Record 4/24/2019, eff. 5/24/2019)
(a) Equipment. Collimating devices capable of restricting the useful beam to the area of clinical interest must be used. The x-ray films or image receptor used as the recording medium during the x-ray examination must show substantial evidence of cut-off (beam delineation). A device must be provided which terminates the exposure after a preset time interval or exposure. The exposure switch must be of the dead-man type and where protective barriers are required must be so arranged that it cannot be operated outside the shielded area.
(b) Each installation must be arranged so that the operator can stand at least 2 meters (6.5 feet) from the patient, the x-ray tube and the useful beam during exposure. A protective barrier must be provided when the operator cannot stand at least 2 meters (6.5 feet) away from the patient, the x-ray tube and the useful beam during exposures.
(c) No person shall hold film during the exposure. Only persons required for the radiographic procedure must be in the radiographic room during exposure.
(Added City Record 4/24/2019, eff. 5/24/2019)
(a) Fixed radiographic installations: equipment.
(1) Collimating devices capable of restricting the useful beam to the area of clinical interest must be used.
(2) The x-ray films or image receptor used as the recording medium during the x-ray examination must show substantial evidence of cut-off (beam delineation).
(3) A device must be provided which terminates the exposure after a preset time interval or exposure. The exposure switch must be of the dead-man type and must be so arranged that it cannot be operated outside a shielded area.
(b) Portable or mobile radiographic installations: equipment.
(1) Collimating devices capable of restricting the useful beam to the area of clinical interest must be used.
(2) The x-ray film or image receptor used as the recording medium during the x-ray examination must show evidence of cut-off (beam delineation).
(3) A device must be provided which terminates the exposure after a preset time interval or exposure.
(4) A dead-man type of exposure switch must be provided with a cord of sufficient length so that the operator can stand at least 2 meters (6.5 feet) from the animal patient, the x-ray tube and out of the useful beam.
(c) Veterinary dental x-ray units. The requirements of 24 RCNY Health Code § 175.49(a) through (r) applies to veterinary dental units with the exception of the ESE requirements of 24 RCNY Health Code § 175.49(q)(3). For hand held dental x-ray units, the same conditions of operation and restrictions on hand held x-ray units (as described in 24 RCNY Health Code § 175.47(j)) apply.
(d) Fluoroscopic installations: equipment.
(1) Equipment must be so constructed that the entire cross-section of the useful beam is always intercepted by a primary protective barrier regardless of the panel-screen distance. For conventional fluoroscopes, this requirement may be assumed to have been met if, when the collimating system is opened to its fullest extent, an unilluminated margin is left on all edges of the fluorescent screen regardless of the position of the screen during use. Equipment with an image receptor must be so constructed that the useful beam cannot exceed the limits of the input phosphor.
(2) The exposure must automatically terminate when the barrier is removed from the useful beam.
(3) The fluoroscopic exposure switch must be of the dead-man type.
(4) Provision must be made to intercept the scattered x-rays from the undersurface of the tabletop and other structures under the table.
(5) The source-panel or source-tabletop distance must always be at least 30 cm (12 in.) and is recommended to be not less than 38 cm (15 in.).
(e) Mobile fluoroscopic equipment must meet the following additional requirements:
(1) In the absence of a tabletop, a cone or spacer frame must limit the source- to-skin distance to not less than 30 cm (12 in.).
(2) Image intensification must always be provided.
(3) It must not be possible to operate a machine unless the useful beam is intercepted by the image receptor.
(f) Conditions for operation of equipment.
(1) Only persons required for the x-ray procedure shall be in the x-ray room during exposures.
(2) When an animal patient must be held in position during exposures, mechanical supporting or restraining devices must be used.
(3) Animal patients or films or image receptors must be held by an individual only under extreme conditions when clinically necessary. Such individuals must wear protective gloves having at least 0.25 mm lead equivalent, a protective garment of at least 0.25 mm lead equivalent, and must keep all parts of their body out of the useful beam.
(4) The exposure of any individual used for holding animals must be monitored.
(5) Pregnant women and individuals under 18 years of age must not hold animal patients or films or image receptors under any conditions.
(6) Protective garments of at least 0.25 mm lead equivalent must be available and must be worn by the fluoroscopist during every fluoroscopy examination.
(Added City Record 4/24/2019, eff. 5/24/2019)
(a) Dual-energy X-ray Absorptiometry (DXA) systems must be:
(1) certified by the manufacturer pursuant to the Medical Device Act and Subchapter C - Electronic Product Radiation Control of Chapter V of the Federal Food, Drug and Cosmetic Act;
(2) registered in accordance with this Article; and
(3) at a minimum, maintained and operated in accordance with the manufacturer's specifications.
(b) Operator requirements. Operators of the bone densitometer must either be a professional practitioner or a Licensed Radiologic Technologist. Operators must complete training specific to patient positioning and the operation of the DXA system.
(c) During the operation of any DXA system, in the absence of a survey performed by or under the supervision of a QMP determining the minimum distance the operator may be from the patient and radiation source, the operator, ancillary personnel, and members of the general public must be positioned at least 2 meters from the patient and DXA system during the examination.
(d) Quality assurance. The facility must follow the manufacturer's quality assurance specifications as to required quality control tests, including their frequency.
(Added City Record 4/24/2019, eff. 5/24/2019)
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)
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