Definitions

The following terms as used in 105 CMR 127.000 shall be interpreted as follows, unless the context or subject matter clearly requires a different interpretation: Annual means a period of time that does not exceed 12 months. Applicant means any person who applies to the Department for a license to operate a mammography facility. In the case of an applicant which is not a natural person, the term "applicant" shall also mean any shareholder owning 5% or more; any officer and any director of any corporate applicant; any limited partner owning 5% or more and any general partner of any partnership applicant; any trustees or any trust applicant; any sole proprietor of any applicant which is a sole proprietorship; any mortgagee in possession; and any executor or administrator of any applicant which is an estate. Asymptomatic means without signs or symptoms of breast disease. Automatic Exposure Control means a device which automatically controls one or more technique factors in order to obtain at a preselected location or locations a required quantity of radiation. Central Ray means the ray of the x-ray beam that is perpendicular to the plane of the image receptor. Charged Coupled Device (CCD) Based Mammography means a method of Digital Mammography in which a light sensitive integrated circuit is used to capture and convert the image to electronic format. Coefficient of Variation means the ratio of the standard deviation to the mean value of a population of observations. Commissioner means the Commissioner of the Massachusetts Department of Public Health or his or her designee. Compression Device means a rigid apparatus that compresses the breast to immobilize the breast and provide uniform thickness during mammography. Computed Radiography (CR) Based Mammography means a type of digital mammography in which a light sensitive phosphor is used to capture the image and then convert to electronic format. Cranio-caudal means a mammographic projection where the image receptor is placed inferior to the breast and the x-ray beam is directed superior to inferior, through the breast. Department means the Massachusetts Department of Public Health. Diagnostic Mammography means the mammographic examination of the breast of a patient with signs or symptoms of breast disease, a possible abnormality detected on screening mammography or other imaging, or who has prior mammography findings requiring imaging follow-up. Diagnostic Physics means the branch of medical physics that deals with the diagnostic applications of ionizing radiation and the equipment associated with its production and use. Digital Breast Tomosynthesis (DBT) (also known as 3-Dimensional (3D) Mammography) means a Digital Mammography (DM) modality where the breast is imaged at multiple angles and digital image slices are created. Digital Mammography (DM) means mammography in which the image is captured on a digital detector, converted into electronic format and displayed either on a softcopy workstation or as a hardcopy laser printout. Digital mammography includes, but is not limited to, Full Field Digital Mammography (FFDM), Computed Radiography (CR) Based Mammography, and Charged Coupled Device (CCD) Based Mammography. Direct Supervision means: (1) For a physician during joint interpretation of mammograms, the supervising interpreting physician reviews, discusses, and confirms the diagnosis of the physician being supervised; and (2) For a mammography technologist, the supervisor is present to observe and correct, as needed, the performance of the individual being supervised who is performing the examination; and (3) For the medical physicist, the supervisor is present to observe and correct, as needed, the performance of the individual being supervised who is conducting the survey. Focal Spot means the area of the target on the anode of an x-ray tube that is struck by electrons emitted from the cathode. The effective focal spot is the actual focal spot observed from the direction of the central ray of the x-ray tube. Full Field Digital Mammography (FFDM) means a type of Digital Mammography in which the field of view is large enough to image the entire breast. Grid means a device used to control scattered radiation that is composed of alternating strips of lead and low x-ray absorption spacer material encased in a protective cover. Half-value Layer (HVL) means the thickness of specified material which attenuates the beam of radiation to an extent that the exposure rate is reduced to ½ of its original value. Image Receptor means any device which transforms incident x-ray photons into a visible image or into another form which can be made into a visible image by further transformation. Interpreting Physician means a licensed physician who interprets mammograms and meets the requirements of 243 CMR 2.07(24). Licensee means any person holding a license to operate a mammography facility. In the case of a licensee that is not a natural person, the term "licensee" shall also mean any shareholder owning 5% or more of any class of the outstanding stock of a privately-held corporation; any limited partner owning 5% or more of the partnership interests and any general partner of a partnership licensee; any trustee of any trust licensee; any sole proprietor of any licensee that is a sole proprietorship; any mortgagee in possession; and any executor or administrator of an estate of a licensee. Machine means a radiation machine designed specifically for mammography. Mammogram means the resulting radiographic image (on a digital soft copy format or hard copy laser printout) produced when mammography is performed. Mammography means radiography of the breast for the purpose of enabling a physician to determine the presence, size, location, and extent of cancerous or potentially cancerous tissue in the breast. Mammography Facility means any facility, whether stationary or mobile, that offers diagnostic or screening mammography services in the Commonwealth to any person. Mammography Modality means a technology for radiography of the breast that requires specialized training for image generation, interpretation, and quality control. Modalities include, but are not restricted to, digital mammography, digital breast tomosynthesis, and stereotactic breast biopsy. Mammography Phantom means a test object used to stimulate radiographic characteristics of compressed breast tissue and containing components that radiographically model aspects of breast disease and cancer. Mammography Radiologic Technologist means an individual licensed as a Radiologic Technologist in both Radiography and Mammography under the provisions of M.G.L. c. 111, § 5L and 105 CMR 125.000: Licensing of Radiologic Technologists. Mamography Unit or Units means an assemblage of components for the production of x-rays for use during mamography, including at a minimum: an x-ray generator, an x-ray control, an x-ray housing assembly, a beam limiting device, and the supporting structures for these components. Medical Physicist means an individual who meets the qualifications of 105 CMR 127.013. Mobile Mammography means diagnostic mammography services offered by transporting a mammography unit to a site for the purpose of performing mammography. Mobile mammography also includes mammography units used in mobile vans. Optimization means the initial selection of operating parameters and equipment set-up process within the mammography facility in which a balance between the minimum patient dose and the maximum diagnostic information is achieved. This process involves the selection and evaluation of all the equipment in the mammographic system through a joint undertaking by the Responsible Physician, the Medical Physicist, the Mammography Radiologic Technologist and the Interpreting Physician. Such equipment includes, but is not limited to: digital image receptors, image processing, and image display systems, grids, kilovolt peak (kVp), exposure time and filtration. Person means any natural person, corporation, partnership, firm, association, society, trust, estate, public or private institution, group, agency, political subdivision of this Commonwealth, any other State or political subdivision or agency thereof, and any legal successor, representative, agent, or agency of the foregoing. Physician means an individual registered by the Board of Registration in Medicine under M.G.L. c. 112 § 2 as a qualified physician. Quality Assurance Procedures Manual (QAPM) means a written document containing the site specific procedures for the mammography facility for the purpose of assuring high quality services for consumers including, but not limited to: procedures for optimization, equipment quality assurance, techniques, policies, and clinical quality assurance. Radiation Control Program means the Radiation Control Program of the Massachusetts Department of Public Health. Radiological Physics means that branch of medical physics which includes diagnostic physics, and medical nuclear physics. Responsible Physician or Lead Interpreting Physician means a physician designated by the licensee to be responsible for the overall quality assurance of the facility. Screening Mammography means the periodic mammographic examination of asymptomatic women to detect unsuspected breast cancer in its earliest stage. Source-image Receptor Distance (SID) means the distance from the source to the center of the input surface of the image receptor. Stereotactic Breast Biopsy (SBB) means a mammography modality used to precisely identify and biopsy an abnormality within the breast. Transfer of Ownership means the following transfers: (1) A transfer of a majority interest in the ownership of a mammography facility; (2) In the case of a privately-held for profit corporation, transfer of a majority of any class of the stock thereof; (3) In the case of a partnership, transfer of a majority of the partnership interest; (4) In the case of a trust, change of the trustee or a majority of trustees; or, (5) In the case of a non-profit corporation, such changes in the corporate membership and/or trustees as the Department determines to constitute a shift in control of the clinic. Transfer of Ownership also means any change in the ownership interest or structure of the clinic or the clinic's organization or parent organization(s) that the Commissioner determines to effect a change in control of the operation of the clinic. A transfer of ownership shall also be deemed to have occurred where foreclosure proceedings have been instituted by a mortgagee in possession. The Commissioner may, in his or her discretion, determine a proposed transaction does not rise to the level of a transfer of ownership.