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§ 30315.36. Mammography Review.

17 CA ADC § 30315.36Barclays 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 § 30315.36
§ 30315.36. Mammography Review.
Currentness
(a) The user shall, upon request, make mammograms and their written reports of results available to the Department and allow those mammograms and reports to be removed from the facility for the purpose of evaluating mammogram image quality.
(b) For sample sizes of two mammographic examinations:
(1) If one mammographic examination fails the review, the user shall submit a plan of corrective action, acceptable to the Department, addressing those areas that resulted in the failure and satisfactorily complete that plan; or
(2) If both mammographic examinations fail the review, the user shall satisfactorily complete a plan of corrective action, as directed by the Department, addressing those areas of the review that resulted in the failure. The user shall be subject to additional review using a larger sample.
(c) For sample sizes greater than two mammographic examinations:
(1) If 20 percent of the mammographic examinations fail the review, the user shall submit a plan of corrective action, acceptable to the Department, addressing those areas that resulted in failure and satisfactorily complete that plan;
(2) If 40 percent of the mammographic examinations fail the review, the user shall satisfactorily complete a plan of corrective action, as directed by the Department, addressing those areas of the review that resulted in the failure;
(3) If 80 percent or more of the mammographic examinations fail the review, the user shall cease the performance of mammography and submit to an additional review and:
(A) If 70 percent or more of the mammographic examinations pass this additional review, the user may restart the performance of mammography after satisfactorily completing a plan of corrective action as directed by the Department and shall, within 75 calendar days of notification that the mammograms passed the review, submit additional mammograms as directed by the Department; or
(B) If less than 70 percent of the mammographic examinations pass this additional review, the user shall not restart the performance of mammography and shall notify every patient who had a mammogram at the facility during the two-year period preceding the date of failure. The notification shall be approved by the Department prior to mailing and include:
1. The name of the patient;
2. The date the patient's mammogram was performed;
3. The statement, “The California Department of Public Health has conducted a review of the mammograms produced by (the name of the facility) and has determined that the mammograms do not meet the standards set by the Department. Therefore, we strongly advise you to consult with your physician as soon as possible regarding a repeat mammographic examination.”
(d) Mammograms reviewed pursuant to this section shall meet the FDA-accepted attributes as specified in title 21, Code of Federal Regulations, section 900.4(c)(2).

Credits

Note: Authority cited: Sections 114975, 115000, 115060 and 131200, Health and Safety Code. Reference: Sections 115060, 115100, 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 subsection (c)(3)(B)3., 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 6/7/24 Register 2024, No. 23.
Cal. Admin. Code tit. 17, § 30315.36, 17 CA ADC § 30315.36
End of Document