California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 5 - Sanitation (Environmental) › Subchapter 4 - Radiation › Group 3 - Standards for Protection Against Radiation › Article 4.5 - Requirements for the Use of X-Ray in Mammography › Section 30315.10 - Definitions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) The definitions in
						section 30100 shall apply to this
						article.
(b) As used in this article:
(1) "Action limit" means the minimum or maximum
						value of a quality assurance measurement representing acceptable
						performance.
(2) "Air kerma" means the
						kerma, measured in Gray (Gy), in a given mass of air.
(3) "Automatic exposure control" (AEC) means a
						device that automatically controls one or more technique factors in order to obtain
						at pre-selected locations a required quantity of radiation.
(4) "Average glandular dose" means the value in
						millirad (mrad) or milligray (mGy) for a given breast or phantom thickness that
						estimates the average absorbed dose for the glandular tissue extrapolated from free
						air exposures and based on fixed filter thickness and target material.
(5) "Continuing education unit" means 50 to 60
						minutes of training received through either:
(A)
						Face-to-face interaction between instructor(s) and student(s), as when the
						instructor provides a lecture, conducts demonstrations, or reviews student
						performance; or
(B) The administration
						and correction of student examinations by an instructor(s) with subsequent feedback
						to the student(s).
(6)
						"Diagnostic mammography" means the mammographic examination of patients who, by
						virtue of symptoms, physical findings, or screening mammography, are considered to
						have a substantial likelihood of having breast disease.
(7) "Direct supervision" means that a mammography
						medical physicist who is conducting the survey is physically present to observe, and
						correct, as needed, the performance of the individual who is performing any portion
						of the survey.
(8) "Established
						operating level" means the value of a particular quality assurance parameter that
						has been established as an acceptable normal level by the facility's quality
						assurance program.
(9) "Facility" means
						a hospital, outpatient department, clinic, radiology practice, an office of a
						physician, mobile setting, or other place or building in which a person conducts
						mammography.
(10) "FDA" means the United
						States Food and Drug Administration.
(11) "Image receptor" means 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.
(12) "Interventional mammography" means the
						creation of a mammogram during invasive interventions for localization or biopsy
						procedures.
(13) "Kerma" means the sum
						of the initial energies of all the charged particles liberated by uncharged ionizing
						particles in a material of given mass.
(14) "Lead supervising physician" means the
						physician designated by the user to establish and maintain the user's mammography
						quality assurance program and who meets the requirements of section
						30315.50(a)(1).
(15) "Mammogram" means an X-ray image of the human
						breast.
(16) "Mammographic examination"
						means the performance of mammography on a human being.
(17) "Mammographic modality" means a technology
						for radiography of the breast such as screen-film mammography, digital mammography,
						full field digital mammography, and digital breast tomosynthesis.
(18) "Mammography" means the procedure for
						creating a mammogram for the purposes of screening, diagnostic, interventional or
						research mammography.
(19) "Mammography
						machine certificate" means the certificate issued pursuant to sections
						30315.22 or
						30315.23 authorizing use of the
						particular radiation machine for mammography.
(20) "Mammography medical physicist" means an
						individual authorized pursuant to section
						30315.60 to conduct mammography
						surveys.
(21) "Mammography system" means
						a system that includes all of the following:
(A) A
						radiation machine used as a source of radiation to produce a mammogram;
(B) An imaging receptor used for the formation of
						a latent image of a mammogram, or for converting X-ray photons to a digital
						signal;
(C) A processing device for
						changing a latent image of a mammogram or a digital signal to a visual image that
						can be used for diagnostic or therapeutic purposes; and
(D) A viewing device, such as a view box or
						computer monitor, used to visually evaluate a mammogram.
(22) "Mammography system evaluation" means an
						evaluation of a mammography system conducted by a mammography medical physicist for
						the purpose of making a preliminary determination as to whether the system is in
						compliance with sections
						30316 and
						30316.20(e).
(23) "Mobile mammography" means mammography
						performed in a mobile setting.
(24)
						"Mobile setting" means a setting in which mammography is performed with a radiation
						machine that is used in a mobile vehicle or is transported to a different location
						for the purpose of performing mammography, but does not include a radiation machine
						moved from room to room within a facility.
(25) "Phantom" means an FDA-approved test object
						used to simulate radiographic characteristics of compressed breast tissue and
						containing components that radiographically model aspects of breast disease and
						cancer.
(26) "Phantom image" means a
						radiographic image of a phantom.
(27)
						"Physical science" means physics, chemistry, radiation science (including medical
						physics and health physics), and engineering.
(28) "Physician" means an individual possessing a
						current and valid license to practice as a physician and surgeon or as an
						osteopathic physician and surgeon pursuant to the California Medical Practice Act
						specified in Business and Professions Code Section
						2000
						et seq.
(29) "Quality assurance testing
						evaluation" means an evaluation of a facility's quality assurance testing by a
						mammography medical physicist to ensure quality assurance testing is performed in
						accordance with section
						30316.20, excluding subsection (e) of
						section 30316.20.
(30) "Quality control technologist" means an
						individual meeting the requirements of section
						30315.50(a)(2) who is
						responsible for those quality assurance tasks specified in section
						30317.10(d).
(31) "Research mammography" means the creation of
						a mammogram with an investigational mammography device as part of a scientific study
						conducted in accordance with FDA's investigational device exemption regulations in
						part 812 of title 21, Code of Federal Regulations.
(32) "Screening mammography" means a mammographic
						examination of asymptomatic persons in an attempt to detect breast cancer when it is
						small, nonpalpable and confined to the breast.
(33) "Source-to-image receptor distance" (SID)
						means the distance from the X-ray source to the center of the input surface of the
						image receptor.
(34) "Standard breast"
						means a 4.2 cm thick compressed breast consisting of 50 percent glandular and 50
						percent adipose tissue.
(35) "Survey,"
						in lieu of the definition found in title 10, Code of Federal Regulations, section
						20.1001 incorporated by reference in
						section 30253, means the on-site performance of
						a mammography system evaluation and a quality assurance testing evaluation by a
						mammography medical physicist.
(36)
						"Traceable to a national standard" means that the instrument used to quantitatively
						measure radiation has been calibrated at:
(A) The
						National Institute of Standards and Technology (NIST); or
(B) A calibration laboratory that participates in
						a proficiency program with NIST at least once every two years during which the
						calibration laboratory achieves agreement within plus or minus 3.0 percent of the
						NIST standard at mammography energy levels.