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§ 30318.10. Additional Requirements for Mobile Mammography.

17 CA ADC § 30318.10Barclays 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 § 30318.10
§ 30318.10. Additional Requirements for Mobile Mammography.
(a) Prior to performing mammography in a mobile setting at a location other than a location identified on the application submitted pursuant to section 30315.22 or 30315.23, the user shall notify the Department of the following information in writing:
(1) The name and physical and mailing address of the user;
(2) The name and telephone number of a contact person for the user;
(3) The physical location of the new location where mammography will be performed;
(4) The registration number issued to the user by the Department;
(5) The unique identification number assigned by the user to the radiation machine pursuant to section 30317.20(a)(1); and
(6) The physical location where mammograms produced at the new location will be processed.
(b) Prior to performing screen-film mammography at a new location, the individual operating the radiation machine shall determine that the standards specified in sections 30316.20(a) and (b) are met. If the processor is not located where mammography is performed:
(1) A phantom image shall be produced using the procedure specified in section 30316.20(b);
(2) The selected peak kilovoltage (kVp) and resulting milliampere-seconds (mAs) used to produce the phantom image shall be recorded and compared to the previously established mAs value that produced a phantom image meeting the criteria specified in section 30316.20(b). If the resulting mAs value is greater than plus or minus 10 percent of the previously established mAs value, mammography may not be performed until corrective action has been taken to bring the resulting mAs value to within 10 percent of the previously established mAs value;
(3) The unprocessed phantom image shall be transported along with any subsequent clinical films in a container that protects the film from exposure to conditions that may damage the mammograms. The phantom image and mammograms shall be processed within 48 hours from the time the mammographic examinations were performed;
(4) Before processing the phantom image, the processor performance shall be tested to ensure that the criteria specified in section 30316.20(a) are met;
(5) Before processing the mammograms, the phantom image shall be processed and evaluated to determine that the phantom image quality meets the criteria specified in section 30316.20(b); and
(6) If the phantom image fails the criteria specified in section 30316.20(b), the mammograms may be processed, but the lead supervising physician shall evaluate each mammogram to determine whether any patients need to be recalled to have their mammographic examination repeated. Prior to further clinical use, the mammography system shall be evaluated and all problems corrected to ensure that the mammography system is in compliance with all requirements of this article.
(c) Each user shall maintain a log for each radiation machine that identifies every date and physical location where mobile mammography was performed, and includes the name of the operator and results of the tests and corrective actions taken pursuant to subsection (b).

Credits

Note: Authority cited: Sections 114975, 115000 and 131200, Health and Safety Code. Reference: Sections 115060, 115115, 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, including amendment of subsections (b) and (c)(1), transmitted to OAL 6-6-2003 and filed 7-18-2003 (Register 2003, No. 29).
3. Amendment of section heading, 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, § 30318.10, 17 CA ADC § 30318.10
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