§ 175.12 Quality Assurance (QA) Program Requirements for Diagnostic Facilities.
RCNY § 175.12
(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.
(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 TemperatureMinimum Immersion Time*C°F°SecondsDeveloper TemperatureMinimum Immersion Time*C°F°Seconds35.5961935952034.5942134932233.5922333912432902531.5892631882730.5872830862929.58530* Immersion time only, no crossover time included.
(d)Additional requirements for facilities using x-ray film.
(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.
(f)Facilities using Computed Radiography (CR) or Direct Digital Radiography (DDR).
(g)Requirements for permitted radiographic facilities' Primary Diagnostic Monitors (PDM).
(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)
