| (C) "probably benign" indicates a finding(s) that has a high probability of being benign; (D) "suspicious abnormality" indicates a finding(s) without all the characteristic morphology of breast cancer but indicating a definite probability of being malignant; (E) "highly suggestive of malignancy" indicates a finding(s) that has a high probability of being malignant; (F) "known biopsy proven malignancy" indicates appropriate action should be taken; (G) "post procedure mammogram" indicates a mammogram to confirm the deployment and position of a breast tissue marker; or (H) "incomplete" indicates there is a need for additional imaging evaluation and/or prior mammograms for comparison. Reasons why no assessment can be made shall be stated by the interpreting physician. (27) First allowable time--The earliest time a resident physician is eligible to take the diagnostic radiology boards from an FDA-designated certifying body. (28) Formal training--Attendance and participation in direct instruction. This does not include self-study programs. (29) Half-value layer (HVL)--The thickness of a specified material that attenuates the beam of radiation to an extent such that the exposure rate is reduced to one-half of its original value. In this definition, the contribution of all scattered radiation, other than any that might be present initially in the beam concerned, is deemed to be excluded. (30) Healing arts--Any system, treatment, operation, diagnosis, prescription, or practice for the ascertainment, cure, relief, palliation, adjustment, or correction of any human disease, ailment, deformity, injury, or unhealthy or abnormal physical or mental condition. (31) Image receptor--Any device that transforms incident x-ray photons either into a visible image or into another form that can be made into a visible image by further transformations. (32) Institutional review board (IRB)--Any board, committee, or other group formally designated by an institution to review, approve the initiation of, and conduct periodic review of biomedical research involving human subjects. (33) Interpreting physician--A licensed physician who interprets mammographic images and who meets the requirements of subsection (r)(1) of this section. (34) Interventional breast radiography--Imaging of a breast during invasive interventions for localization or biopsy procedures. (35) Investigational device exemption--An exemption that allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval application or a 510(k) Premarket Notification submission to FDA. (36) Kerma--The sum of the initial energies of all the charged particles liberated by uncharged ionizing particles in a material of given mass. (37) Laterality--The designation of either the right or left breast. (38) Lead interpreting physician--The interpreting physician assigned the general responsibility for ensuring that a facility's quality assurance program meets all of the requirements of subsections (u), (v), and (w) of this section. (39) Mammogram--A radiographic image produced through mammography. (40) Mammographic modality--A technology for radiography of the breast. Examples are screen-film mammography and full-field digital mammography. (41) Mammography--The use of x-radiation to produce an image of the breast that may be used to detect the presence of pathological conditions of the breast. For the purposes of this section, mammography does not include radiography of the breast performed as follows: (A) during invasive interventions for localization or biopsy procedures except as specified in subsection (gg) of this section; or (B) with an investigational mammography device as part of a scientific study conducted in accordance with FDA's investigational device exemption regulations. (42) Mammography machine(s)--A unit consisting of components assembled for the production of x-rays for use during mammography. These include, at a minimum, the following: (A) an x-ray generator; (B) an x-ray control; (C) a tube housing assembly; (D) a beam limiting device; and (E) supporting structures. (43) Mammography medical outcomes audit--A systematic collection of mammography results compared with outcomes data. (44) Mammography system--A system that includes the following: (A) an x-ray machine used as a source of radiation in producing images of breast tissue; (B) an imaging system used for the formation of a latent image of breast tissue; (C) an imaging-processing device for changing a latent image of breast tissue to a visual image that can be used for diagnostic purposes; (D) a viewing device used for the visual evaluation of an image of breast tissue if the image is produced in interpreting visual data captured on an image receptor; (E) a medical radiologic technologist who performs mammography; and (F) a physician who engages in mammography and who meets the requirements of this section relating to the reading, evaluation, and interpretation of mammograms. (45) Mandatory training--Additional training required by the agency certifying body or FDA-approved accreditation body for interpreting physicians, medical radiologic technologists, or medical physicists as the result of a required corrective action. (46) Mean optical density--The average of the optical densities measured using uniform, defect-free absorber thicknesses of 2, 4, and 6 centimeters (cm) with values of kilovolt peak (kVp) clinically appropriate for those thicknesses. (47) Medical physicist--An individual who performs surveys and evaluations of mammographic equipment and facility quality assurance programs in accordance with this section and who meets the qualifications in subsection (r)(3) of this section. (48) Medical radiologic technologist (operator of equipment)--An individual specifically trained in the use of radiographic equipment and the positioning of patients for radiographic examinations, who performs mammography examinations in accordance with this section and who meets the qualifications in subsection (r)(2) of this section. (49) Mobile service operation--The provision of mammography machines and personnel at temporary sites for limited time periods. (50) Multi-reading--Two or more physicians interpreting the same mammogram. At least one physician shall be qualified as an interpreting physician. (51) Optical density (OD)--A measure of the fraction of incident light transmitted through a developed film and defined by the equation: Attached Graphic (52) Patient--Any individual who undergoes a mammography examination in a facility, regardless of whether the person is referred by a physician or is self-referred. (53) Phantom--A test object used to simulate radiographic characteristics of compressed breast tissue and containing components that radiographically model aspects of breast disease and cancer. (54) Phantom image--A radiographic image of a phantom. (55) Physical science--This includes physics, chemistry, radiation science (including medical physics and health physics), and engineering. (56) Positive mammogram--A mammogram that has an overall assessment of findings that are either "suspicious" or "highly suggestive of malignancy." (57) Practitioner of the healing arts (practitioner)--For the purposes of this section, a person licensed to practice healing arts by the Texas Medical Board as a physician. (58) Provisional certification--A provisional authorization described in subsection (g) of this section. (59) Qualified instructor--An individual whose training and experience prepares him or her to carry out specified training assignments. Interpreting physicians, medical radiologic technologists, or medical physicists who meet the requirements of subsection (r) of this section would be considered qualified instructors in their respective areas of mammography. Other examples of individuals who may be qualified instructors for the purpose of providing training to meet the requirements of this section include, but are not limited to, instructors in a post-high school training institution and manufacturers' representatives. (60) Quality control technologist--An individual meeting the requirements of subsection (r)(2) of this section who is responsible for those quality assurance responsibilities not assigned to the lead interpreting physician or to the medical physicist. (61) Radiation machine--For the purposes of this part, radiation machine also means mammography machine. Cont'd... |
