Mammography Requirements: Mammography X-Ray Systems Definitions
(1)“Air Kerma” means the sum of the initial energies of all the charged particles liberated by uncharged ionizing particles in a given mass of air. The unit used to measure the quantity of kerma is the gray (Gy). For X-rays with energies below 300 kiloelectronvolts (keV), 1Gy=100 rad and is equivalent to 114 (R) of exposure.
(2)“FDA” means the Food and Drug Administration.
(3)An “image receptor support surface” means that portion of the image receptor support which is the X-ray input surface and is used to support the patient’s breast during mammography.
(4)“Interpreting physician” means a licensed physician who interprets mammographic images and meets the qualifications of OAR 333-106-0750 (Mammography Requirements: Mammography Personnel Qualifications)(2).
(5)“Lead Interpreting Physician” means a physician who interprets mammographic images, meets the qualifications of OAR 333-106-0750 (Mammography Requirements: Mammography Personnel Qualifications)(2), and who has the general responsibility for ensuring that the registrant’s quality assurance program meets all applicable rules and regulations.
(6)“Mammographic screening” means the use of radiation to test women for the detection of diseases of the breast when such tests are not specifically and individually ordered by a licensed practitioner of the healing arts legally authorized to prescribe such tests for the purposes of diagnosis. Screening is considered as self-referral by asymptomatic women without physicians orders (see OAR 333-100-0020 (Prohibited Uses)(5)(6) and 333-106-0035 (General Requirements: Deliberate Exposures Restricted)(3)).
(7)“Mammography” means radiography of the breast.
(8)“Mammography equipment evaluation” means an onsite assessment of a mammography unit(s) or image processor performance by a medical physicist for the purpose of making a preliminary determination as to whether the equipment meets all of the applicable state and federal standards.
(9)“Mammography unit(s)” means an assemblage of components for the production of X-rays for use during mammography, including, at a minimum; An X-ray generator, an X-ray control, a tube housing assembly, a beam limiting device, and the supporting structures for these components.
(10)“Medical Physicist” means a person trained in evaluating the performance of mammography equipment and quality assurance programs and meets the qualifications of OAR 333-106-0750 (Mammography Requirements: Mammography Personnel Qualifications)(3).
(11)“MQSA” means the Mammography Quality Standards Act of 1992.
(12)“Phantom” means a test object used to simulate radiographic characteristics of compressed breast tissue and containing components that radiographically model aspects of breast disease and cancer. (The “FDA accepted phantom” meets this requirement.)
(13)“Quality Assurance” is a comprehensive concept that comprises all of the management practices instituted by the registrant or the registrant’s representative/s to ensure that:
(a)Every imaging procedure is necessary and appropriate to the clinical problem at hand;
(b)The images generated contain information critical to the solution of that problem;
(c)The recorded information is correctly interpreted and made available in a timely fashion to the patient’s physician;
(d)The examination results in the lowest possible radiation exposure, cost, and inconvenience to the patient, consistent with subsection (13)(b) of this rule.
(14)“Quality Assurance Program” includes such facets as efficacy studies, continuing education, quality control, preventive maintenance, and calibration of equipment.
(15)“Quality Control” means a series of distinct technical procedures that ensure the production of a satisfactory product,such as a high quality screening or diagnostic image.
(16)“Quality Control Technologist” means an individual who is qualified under MQSA, and who is responsible for those quality assurance responsibilities not assigned to the Lead Interpreting Physician or to the Medical Physicist.
(17)“Resting period” means the period of time necessary to bleed out air that has been trapped between the radiographic film and intensifying screen during the loading process in the darkroom. This period of time is usually measured in minutes and determined by the individual manufacturer of the intensifying screen/mammography cassette combination.
(18)“Standard Breast” means a 4.2 cm thick compressed breast, consisting of 50 percent adipose, and 50 percent glandular tissue.
(19)“Survey” means an onsite physics consultation and evaluation of a registrant’s mammography equipment, and quality assurance program performed by a medical physicist.
Rule 333-106-0700 — Mammography Requirements: Mammography X-Ray Systems Definitions,