New York Codes, Rules and Regulations
Title 10 - DEPARTMENT OF HEALTH
Chapter I - State Sanitary Code
Part 16 - Ionizing Radiation
General Provisions
Section 16.23 - Quality assurance programs for diagnostic facilities
Universal Citation: 10 NY Comp Codes Rules and Regs ยง 16.23
Current through Register Vol. 46, No. 39, September 25, 2024
(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.
Disclaimer: These regulations may not be the most recent version. New York may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
