Quality Assurance (QA) Program Requirements for Diagnostic Facilities.
24 RCNY § 175.12
in effect§ 175.12 Quality Assurance (QA) Program Requirements for Diagnostic Facilities.
(a) Purpose and scope. This section establishes quality assurance (as defined in 24 RCNY Health Code § 175.08) requirements for the use of machine-produced radiation or the radiation therefrom for diagnostic uses in the healing arts. The requirements in this section are intended to provide for the protection of the public health and safety and are in addition to, and not in substitution for, other applicable requirements in this Article.
(b) Diagnostic facilities.
(1) Except dental, podiatric or veterinary facilities, each radiation installation performing diagnostic x-rays on humans must implement a quality assurance program that includes at a minimum:
(i) the adoption of a facility- and equipment-specific QA manual containing written policies and procedures for radiation protection and describing the facility's quality assurance program. Policies and procedures must be consistent with the types of equipment and services provided including, but not limited to, identification of patients, use of gonadal or scoliosis shielding, personnel monitoring, protection of pregnant workers and patients and holding of patients. The quality assurance manual must describe the various processing, generator and systems QA tests appropriate for the types of equipment and services provided in sufficient detail to ensure that they will be performed properly;
(ii) the performance of QA tests and correction of deficiencies as specified in the QA manual;
(iii) the maintenance of equipment records for each diagnostic imaging system, containing test results, records of equipment repairs and other pertinent information;
(iv) requirements for performing appropriate testing as determined by the QMP after replacement or repair of equipment components that could adversely affect the resolution of the x-ray system and/or could cause an increase in patient dose;
(v) the provisions of a formalized in-service training program for employees including, but not limited to, quality assurance and radiation safety procedures;
(vi) the direct or indirect determination of radiation output at the point of skin entry for examinations routinely performed at the facility;
(vii) the provision of the information described in subparagraph (vi) of this paragraph to any patient upon request; and
(viii) the performance of and analysis of repeated, rejected or diagnostic events which are designed to identify and correct problems and to optimize quality.
(2) Each registrant must maintain written records documenting QA and audit activities for review by the Department. Such records must be maintained by the registrant at least until after the next scheduled inspection is completed by the Department.
(3) Diagnostic facility registrants required to maintain the facility-specific QA manual must comply with the requirements of this Article, as well as any registration conditions or Department directives or orders. Failure to maintain an up-to-date QA manual, or not adhering to this Article or Department directives or orders, shall be deemed as equivalent to the registrant not conducting a mandated QA program in violation of this section.
(4) For hospital registrants only, a QMP, or the Radiation Safety Officer working with a QMP, must conduct oversight of its quality assurance programs, by:
(i) auditing the QA program on an annual basis for compliance with the hospital's QA manual and the requirements of this Article; and
(ii) submitting the annual audit report to the hospital radiation safety committee. The annual audit report must document the review of the following:
(A) the hospital's personnel monitoring program for compliance with this Article and hospital QA manual requirements; and
(B) the hospital's equipment QA testing, including frequency of testing, and resolution of equipment failures as to timely repair and testing, if any; and
(C) the calibration of radiation instruments used for equipment testing, if owned by the hospital; and
(D) the status of hospital employee training, both annual training requirements and Article requirements, for training hospital staff for specific equipment types; and
(E) review of all medical events that occurred in the hospital in relation to x-ray exams and an evaluation of the measures to prevent such re-occurrences and their effectiveness.
(iii) The recommendations cited in the annual hospital audit report of subparagraph (ii) of paragraph (4) of this subdivision must be reviewed by the hospital radiation safety committee for a compliance determination. A written record of the hospital radiation safety committee decisions on the annual audit recommendations must be retained for review by the Department during periodic inspections.
(5) Neonatal imaging. Neonatal intensive care units must develop a QA program which includes the following protocols:
(i) establishing a technique chart for neonatal imaging including, at a minimum, specific techniques for chest and abdomen, along with corresponding direct or indirect determination of entrance skin dose; and
(ii) an annual training program for Licensed Radiographic Technologists (LRTs) for conducting neonatal imaging; and
(iii) a protocol for the proper use of neonatal collimation; and
(iv) a protocol of gonadal shielding; and
(v) each facility must conduct an annual report on the compliance with the facility's neonatal QA program and forward such report to the facility radiation safety committee for review
(6) Each registrant that conducts x-ray imaging of children must establish specific techniques at least for 1-year old, 5-year old and 10-year old children, specific to PA chest and abdomen x-ray studies. Additionally, the entrance skin exposure must be directly or indirectly determined for the latter studies and posted in the facility along with the technique chart wherever it is reasonable to expect that children of such an age group can be x-rayed.
(c) X-ray film processing facilities. Registrants using analog image receptors (e.g., radiographic film) must have available suitable equipment for the handling and processing of radiographic film in accordance with the following provisions:
(1) Manually developed film shall be prohibited, except during dental surgical procedures when required.
(2) Automatic processors and other closed processing systems:
(i) automatic processors must be operated and maintained following manufacturer specifications.
(ii) films must be developed in accordance with the time-temperature relationships recommended by the film manufacturer; in the absence of such recommendations, the film must be developed using the following chart:
Developer Temperature Minimum Immersion Time*
C° F° Seconds
35.5 96 19
35 95 20
34.5 94 21
34 93 22
33.5 92 23
33 91 24
32 90 25
31.5 89 26
31 88 27
30.5 87 28
30 86 29
29.5 85 30
* Immersion time only, no crossover time included.
(3) Processing deviations from the above requirements of this section must be documented by the registrant in such manner that the requirements are shown to be met or exceeded (e.g., extended processing and special rapid chemistry).
(d) Additional requirements for facilities using x-ray film.
(1) Pass boxes, if provided, must be constructed to exclude light from the darkroom when cassettes are placed in or removed from the boxes and must incorporate adequate shielding from stray radiation to prevent exposure of undeveloped film.
(2) Darkrooms typically used by more than one individual must prevent accidental entry while undeveloped films are being handled or processed.
(3) Film must be stored in a cool, dry place and must be protected from exposure to stray radiation. Film in open packages must be stored in a light-tight container.
(4) Film cassettes and intensifying screens must be inspected periodically and must be cleaned and replaced as necessary.
(5) Outdated x-ray film past the manufacturer's expiration date must not be used for diagnostic radiographs of patients.
(6) The film and intensifying screen must be spectrally compatible.
(7) Facilities must maintain a light-tight darkroom, use proper safelighting and safeguards, and evaluate darkroom integrity and daylight loading systems for film fog every 6 months and after a change that may impact film fog.
(e) X-ray film processing facilities other than dental, podiatry or veterinary must:
(1) have a continuous and documented sensitometric QA program, including QA tests for speed, contrast and fog. These tests must be performed according to specifications of the manufacturer, a QMP, or a nationally-recognized organization.
(2) maintain a light-tight darkroom and use proper safelighting and safeguards such that any film type in use exposed in a cassette to x-radiation sufficient to produce an optical density from 1 to 2 when processed shall not increase in optical density by more than 0.1 when exposed in the darkroom for 2 minutes with all safelights on. If used, daylight film handling boxes must preclude fogging of the film.
(3) limit the base plus fog of unexposed film to an optical density less than 0.25 when developed by the routine procedure used by the facility.
(f) Facilities using Computed Radiography (CR) or Direct Digital Radiography (DDR).
(1) Commencing July 1, 2021, when exposure indicators are available, the facility must establish and document an acceptable range for the exposure values for examinations routinely performed at the facility. The indicated exposure values for a representative percentage of images taken must be compared to the established range. Consistent deviations from established ranges must be investigated, corrective actions taken as necessary, and results documented. This exposure range developed above must be posted at or near the x- ray console.
(2) Facilities must establish and follow an image QA program in accord with the recommendations of a QMP, the system manufacturer, or a nationally recognized organization
(3) Facilities other than dental, podiatric and veterinary, must quarterly complete phantom image evaluation using a phantom approved by a QMP or manufacturer. The analysis at a minimum must include: artifacts, spatial resolution, contrast/noise and exposure indicator constancy.
(4) In addition to the requirements of paragraphs (1) through (3) of this subdivision, CR facilities must establish a schedule of CR cassette erasure consistent with the manufacturer's recommendations.
(g) Requirements for permitted radiographic facilities' Primary Diagnostic Monitors (PDM).
(1) The requirements of this subdivision do not apply to dental, podiatric, veterinary, bone densitometer, nuclear medicine imaging and mammography facilities.
(2) The following definitions apply to this subdivision:
"Digital Imaging and Communications in Medicine (DICOM)" means a standard for handling, storing, printing and transmitting information in medical imaging.
"Documenting" means written, electronic or photographic records of testing performance.
"Maximum luminance" means the maximum light emission from the PDM front surface as measured by a calibrated photometer in units of candela/m2.
"Medical monitor" means any monitor that has both a built-in photometer and a QA software program allowing for routine QA tests to be performed.
"Monitor" means a display device that shows the results of a patient radiological image.
"Off-site PDM" means when the registrant contracts with a tele-radiology service for patient diagnosis of x-ray procedures. In such circumstances, the tele-radiology service must establish a PDM QA program that conforms to Department requirements.
"Primary Diagnostic Monitor (PDM)" means a monitor used to render a final diagnosis of a patient exam, including interpretations of patient mammograms. Monitors attached to digital units used as PDMs must have a QA program that complies with Department requirements, with the exception of monitors attached to bone densitometer units.
"Preliminary reads ("wet reads")" means a type of monitor that is exempt from PDM requirements. For purposes of this section, monitors used for wet reads, such as a monitor in a hospital emergency room used to make decisions about trauma patients and monitors of fluoroscopy units, are not considered PDMs.
"Registrant" means, for the purposes of the PDM QA requirements of this subdivision, the individual responsible for ensuring that a PDM QA program is implemented on site. This requirement still applies if the registrant contracts with an off-site service, for example, tele-radiology service, for patient final diagnostic evaluations.
"Test pattern" means, for the purposes of PDM QA requirements, a pattern that is either a Society of Motion Picture and Television Engineers (SMPTE) test pattern, or the American Association of Medical Physicists (AAPM) Task Group (TG) #18 test pattern (TG 18 test pattern) or a test pattern from an applicable successor national standard.
(3) QA tests mandated for a PDM QA program. Each facility must make or have made QA tests to monitor equipment performance and maintain records of data collected. The facility must document their PDM quality assurance program in the facility's QA manual along with the results of the QA tests required. The QA tests required to be performed must include, at a minimum:
(i) Visual test pattern evaluation (TG-18QC, SMPTE, or equivalent).
(ii) DICOM calibration of the Grayscale Standard Display Function (GSDF) for each medical monitor on site at the registrant's location.
(iii) Maximum luminance output.
(iv) Minimum luminance output.
(v) Luminance ratio of maximum to minimum.
(vi) Evaluation of viewing conditions.
(Added City Record 4/24/2019, eff. 5/24/2019)
Source: City of New York, Charter, Administrative Code and Rules (American Legal Publishing XML export, codelibrary.amlegal.com)URL: https://codelibrary.amlegal.com/codes/newyorkcity/latest/NYCrules/0-0-0-116954Fetched: 10/24/2026