N.Y. Comp. Codes R. & Regs. tit. 10 § 16.23

Current through Register Vol. 46, No. 45, November 2, 2024

Section 16.23 - Quality assurance programs for diagnostic facilities

(a) A quality assurance program is a system of plans, actions, reviews, reports and records whose purpose is to ensure that diagnostic facilities achieve consistently high quality imaging and other diagnostic results, while maintaining radiation output and personnel doses within limits prescribed by the department.

(1) Each radiation facility conducting diagnostic X-ray or radioactive materials procedures, excepting dental, podiatric and veterinary facilities, shall implement a quality assurance program including at a minimum:

(i) the adoption of a 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, use of gonad or scoliosos 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 quality control 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 quality control tests and the correction of deficiencies as specified in the quality assurance manual;

(iii) the maintenance of equipment records for each diagnostic imaging system, containing test results, records of equipment repairs and other pertinent information;

(iv) the provision of a formalized in-service training program for employees, including, but not limited to, quality assurance and radiation safety procedures;

(v) the measurement of radiation output at the point of skin entry for common X-ray examinations;

(vi) the measurement of the amount of activity of each dose of a radiopharmaceutical administered to a patient;

(vii) the calculated absorbed dose for diagnostic procedures involving radioactive materials;

(viii) the provision of the information described in subparagraphs (v), (vi) and (vii) of this paragraph to any patient upon request; and

(ix) the conduct of an ongoing analysis of repeated, rejected or misadministered diagnostic studies which is designed to identify and correct problems and to optimize quality.

(b) Mammography image quality. Each facility performing mammography examinations shall ensure that the mammographic system is optimized to provide consistent, high quality imaging. A mammography system includes the X-ray generator, X-ray tube, image receptor and all components of the imaging process. The facility shall use a breast equivalent phantom approved by the department to monitor image resolution. The breast phantom contains test objects which represent low density areas and micro-calcifications which are related to the imaging of breast lesions. A test object is either a mass, fiber, or speck set as constituents of, and exemplified by, the model breast phantoms hereafter described.

(1) No patient mammograms shall be performed unless the minimum test object resolution established in paragraph (2) of this subdivision is met.

(2) The mammography system shall be capable of imaging, at the minimum, the following test objects:

(i) 0.75 millimeter (mm) mass, 0.75 mm fiber and 0.54 mm speck set using the Model 152D phantom manufactured by Radiation Measurements Inc. (RMI); or

(ii) the 0.75 mm mass, 0.75 mm fiber, and 0.40 mm speck set using the American College of Radiology (ACR) mammography accreditation phantom; or

(iii) the equivalent test object resolution on another approved phantom.

(3) All facilities shall optimize the mammography systems used and determine the breast equivalent phantom test object resolution of the system prior to performing patient mammograms. The number of test objects resolved is the reference image the facility shall use for comparison during periodic testing. Under any conditions, if during the testing required under subdivision (a) of this section, the system is found to have lost the ability to resolve two test objects previously visible in the reference image, the facility shall investigate the reason and optimize the system.

(4) Diminished phantom test object resolution and facility follow-up.

(i) Whenever the phantom image indicates that the mammography system fails to meet the minimum test object resolution defined in paragraph (2) of this subdivision the facility shall investigate the reason. Correction to achieve the minimum level shall be completed prior to performance of patient mammograms.

(ii) In addition, if the imaging system resolves fewer than seven test objects on the RMI Model 152D phantom, the ACR phantom, or the equivalent on another approved phantom, the investigation shall include:

(a) a review of monthly phantom images to determine at which point the image resolution fell below the minimum; and

(b) a review by a panel of physicians selected by the department for this review of mammograms performed since the last phantom image that was identified as meeting the minimum level. Physicians selected for the panel must be certified in diagnostic radiology by the American Board of Radiology or the American Osteopathic Board of Radiology or have equivalent qualifications and will be selected for addition to this panel in consultation with the New York State Radiological Society. Members of the panel are deemed volunteers in service to the department within the meaning of paragraph (a) of subdivision one of section 17 of the Public Officers Law and, in lieu of expenses, shall be compensated by the department at the prevailing departmental per diem rate. The cases chosen for review shall include images from the range of studies performed by the facility which the panel ascertains to be sufficient to determine that the clinical images are of diagnostic quality. A record of the review and findings shall be maintained for inspection.

(iii) If film images are identified by the physician conducting the review as non-diagnostic, the facility shall, within five business days, notify:

(a) the referring physician, or other authorized referring practitioner as defined in section 16.19(a) of this Part, or the patient, if not referred by a practitioner, of the need for follow-up; and

(b) the department of the results of the investigation and follow-up contacts.

(iv) A record of the results of the investigation and actions taken to correct any deficiency shall be maintained for review by the department for a period of three years.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 16.23