| (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. (62) Self-referral mammography--The use of x-radiation to test asymptomatic women for the detection of diseases of the breasts when such tests are not specifically and individually ordered by a licensed physician. (63) Serious adverse event--An adverse event that may significantly compromise clinical outcomes, or an adverse event for which a facility fails to take appropriate corrective action in a timely manner. (64) Serious complaint--A report of a serious adverse event. (65) Source-to-image receptor distance (SID)--The distance from the source to the center of the input surface of the image receptor. (66) Standard breast--A 4.2 cm thick compressed breast consisting of 50% glandular and 50% adipose tissue. (67) Survey--An on-site physics consultation and evaluation of a facility quality assurance program performed by a medical physicist. (68) Technique chart--A chart that provides all necessary generator control settings and geometry needed to make clinical radiographs. (69) Traceable to a national standard--Calibrated at either the National Institute of Standards and Technology (NIST) or at a calibration laboratory that participates in a proficiency program with NIST at least once every two years. The results of the proficiency test conducted within 24 months of calibration shall show agreement within plus or minus 3.0% of the national standard in the mammography energy range. (d) Prohibitions. (1) Radiographic equipment designed for general purpose or special nonmammography procedures shall not be used for mammography. This includes systems that have been modified or equipped with special attachments for mammography. (2) The agency may prohibit use of mammography machines that pose a significant threat or endanger public health and safety, in accordance with §289.231 of this title and §289.205 of this title. (3) Individuals shall not be exposed to the useful beam except for healing arts purposes and unless such exposure has been authorized by a licensed physician. This provision specifically prohibits intentional exposure for the following purposes: (A) exposure of an individual for training, demonstration, or other non-healing arts purposes; (B) exposure of an individual for the purpose of healing arts screening (self referral mammography) except as authorized by subsection (bb) of this section; and (C) exposure of an individual for the purpose of research except as authorized by subsection (cc) of this section. (e) Exemptions. (1) Mammography machines or cabinet x-ray machines used exclusively for examination of breast biopsy specimens are exempt from the requirements of this section. These machines are required to meet applicable provisions of §289.226 of this title and §289.228 of this title (relating to Radiation Safety Requirements for Analytical and Other Industrial Radiation Machines). (2) Mammography machines used exclusively for interventional breast radiography are exempt from the requirements of this section except for those listed in subsection (gg) of this section. These machines are not required to be accredited by an FDA-approved accreditation body. (3) Loaner machines as described in subsection (n)(5) of this section are exempt from the inspection requirements in subsection (ff) of this section. These machines are not required to be accredited by an FDA-approved accreditation body. (4) Mammography machines with investigational device exemptions as described in subsection (cc) of this section and used in clinical studies are exempt from the requirements of this chapter. These machines are not required to be accredited by an FDA-approved accreditation body. (5) All mammography registrants are exempt from the posting of radiation area requirements of §289.231(x) of this title provided that the operator has continuous surveillance and access control of the radiation area. (f) Requirements for mammography systems certification. Cont'd... |
