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§ 30315.33. Acceptable Application for a Mammography Machine Certificate.

17 CA ADC § 30315.33Barclays 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 § 30315.33
§ 30315.33. Acceptable Application for a Mammography Machine Certificate.
Currentness
(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.

Credits

Note: Authority cited: Sections 114975, 115000, 115060 and 131200, Health and Safety Code. Reference: Sections 115060, 131050 and 131051, Health and Safety Code.
History
1. New 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 transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).
3. Amendment of subsection (a)(15)(A) and Note filed 7-11-2007; operative 8-10-2007 (Register 2007, No. 28).
4. Amendment of section heading, repealer and new section and amendment of 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 6/7/24 Register 2024, No. 23.
Cal. Admin. Code tit. 17, § 30315.33, 17 CA ADC § 30315.33
End of Document