Current through Register Vol. 61, No. 4, April 1, 2022
In addition to the definitions provided in division 100 and 106
of this chapter, the following definitions shall be applicable to the rules in
(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
(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
"Interpreting physician" means a licensed physician who interprets mammographic
images and meets the qualifications of OAR
"Lead Interpreting Physician"
means a physician who interprets mammographic images, meets the qualifications
and who has the general responsibility for ensuring that the registrant's
quality assurance program meets all applicable rules and regulations.
"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
(7) "Mammography" means
radiography of the breast.
"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
Physicist" means a person trained in evaluating the performance of mammography
equipment and quality assurance programs and meets the qualifications of OAR
(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.)
"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
4.2cm thick compressed breast, consisting of 50 percent adipose, and 50 percent
means an onsite physics consultation and evaluation of a registrant's
mammography equipment, and quality assurance program performed by a medical