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 30315.33 - Acceptable Application for a Mammography Machine Certificate

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) An application submitted for compliance with
						sections 30315.22 and
						30315.23 shall be considered acceptable
						if the application contains the following information:
(1) The name and mailing and physical address of
						the user;
(2) The name and telephone
						number of a contact person for the user;
(3) The registration number issued by the
						Department pursuant to section
						30108 and the expiration date of
						registration;
(4) The name of the lead
						supervising physician designated by the user;
(5) The name of the quality control technologist
						designated by the lead supervising physician;
(6) For each physician who may supervise
						individuals performing mammography, the name, certificate number, and expiration
						date as shown on the certificate or permit issued pursuant to section
						30466;
(7) For each individual who may perform
						mammography, the name, certificate number, and expiration date shown on the
						certificate issued to the individual pursuant to section
						30455.1;
(8) For each mammography system that may be used
						for mammography:
(A) The manufacturer, model,
						mammographic modality, serial number, and unique identification number of the
						radiation machine required pursuant to section
						30317.20(a)(1);
(B) Whether the machine will be used in a mobile
						setting. If the machine will not be used in a mobile setting, the designated room
						number within the facility where the machine is installed or fixed;
(C) The manufacturer, model, and location of each
						film processor that may be used to process mammograms;
(D) Whether the machine will be used for
						screening, diagnostic, research, or interventional mammography, or any combination
						thereof; and
(E) A copy of the report
						indicating the results of a mammography system evaluation performed by a mammography
						medical physicist less than six months prior to the date of the application, or, in
						lieu thereof for renewal applications, a copy of the report indicating the results
						of a survey performed less than 12 months, by a mammography medical physicist, prior
						to the date of the renewal application. If the mammography system evaluation report
						or the survey report identifies deficiencies or recommendations for improvements in
						facility operations, provide:
1. A list and
						description of corrective actions taken and the date corrections were
						achieved;
2. Copies of work
						invoices;
3. Documentation that those
						corrective actions were taken and those actions corrected the deficiencies or that
						those recommendations were followed; and
(9) If the applicant will perform mammography in a
						mobile setting:
(A) The physical address of each
						location where mammography will be performed;
(B) For each location where mammography will be
						performed, the name and telephone number of the responsible person who is allowing
						the service to be provided at the location;
(C) Whether the mammograms will be processed with
						an on-board processor or at specific locations. If the facility will process
						mammograms at specific locations, the physical address of each location where
						mammograms will be processed;
(D)
						Whether the radiation machine is used in a mobile vehicle or is transported to the
						use location and moved to where mammographic examinations will be performed. If the
						radiation machine is moved to where mammographic examinations will be performed, the
						designated room number within the physical building at each location of use;
						and
(E) A description of the quality
						assurance tests that will be performed each time the radiation machine is
						relocated.
(10) The signature,
						title, and date of signature, of the user and the user's designated lead supervising
						physician.