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§ 30315.10. Definitions.

17 CA ADC § 30315.10Barclays Official California Code of Regulations

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

Credits

Note: Authority cited: Sections 114975, 115060 and 131200, Health and Safety Code. Reference: Sections 115060, 131050, 131051 and 131052, Health and Safety Code.
History
1. New article 4.5 (sections 30315.10-30320.90) and section filed 2-10-2003 as an emergency; operative 2-10-2003 (Register 2003, No. 7). A Certificate of Compliance must be transmitted to OAL by 6-10-2003 or emergency language will be repealed by operation of law on the following day.
2. Certificate of Compliance as to 2-10-2003 order, including amendment of subsections (b)(17) and (b)(33), transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).
3. Amendment of section and Note filed 12-18-2019; operative 7-1-2020 pursuant to Government Code section 11343.4(b)(2) (Register 2019, No. 51).
This database is current through 4/26/24 Register 2024, No. 17.
Cal. Admin. Code tit. 17, § 30315.10, 17 CA ADC § 30315.10
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