Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 127.000 - Licensing Of Mammography Facilities › General › Section 127.005 - Definitions

Current through Register 1525, July 5, 2024
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.