Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 106 - X-RAYS IN THE HEALING ARTS › Section 333-106-0700 - Mammography X-Ray Systems Definitions

Current through Register Vol. 63, No. 7, July 1, 2024
In addition to the definitions provided in division 100 and 106
				of this chapter, the following definitions shall be applicable to the rules in
				this division.
(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(2).
(5) "Lead Interpreting Physician"
			 means a physician who interprets mammographic images, meets the qualifications
			 of OAR
			 333-106-0750(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(5)(6)
 
			 and
			 333-106-0035(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(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.