§ 175.47 General Requirements for All Radiation Equipment.
RCNY § 175.47
(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.
(u)Beam quality.
(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.
(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)
