Cal. Code Regs. tit. 17 § 30315.60

Current through Register 2024 Notice Reg. No. 20, May 17, 2024
Section 30315.60 - Authorization and Renewal of Authorization to Conduct Mammography Surveys, Revocation and Suspension of Authorization and Application Processing Times
(a) To be eligible for authorization to conduct mammography surveys, an individual shall submit an acceptable application consisting of the following:
(1) Name, social security number (SSN) or individual taxpayer identification (ITIN) (pursuant to the authority found in sections 100275 and 115100 of the Health and Safety Code and as required by section 17520 of the Family Code, providing the SSN or ITIN is mandatory. The SSN or ITIN will be used for purposes of identification), mailing address, and daytime telephone number and email address;
(2) Documentation that the applicant meets the requirements of sections 30315.52(a)(2) through (4).
(3) A copy of a survey report indicating the name of the mammography medical physicist providing direct supervision and that the applicant performed all tests and the evaluations specified in section 30316.60; or
(4) In lieu of subsection (a)(2), a copy of the letter issued to the applicant by the FDA, or a certifying agency approved by the FDA pursuant to title 21, Code of Federal Regulations, section 900.21, stating that the applicant met the requirements of title 21, Code of Federal Regulations, section 900.12(a)(3).
(b) Authorization shall be valid for three years.
(c) To be eligible for renewal of authorization to conduct mammography surveys an individual shall, 30 days prior to the expiration date of their authorization, submit to the Department an application that includes all of the following:
(1) Name, SSN or ITIN (pursuant to the authority found in sections 100275 and 115100 of the Health and Safety Code and as required by section 17520 of the Family Code, providing the SSN or ITIN is mandatory. The SSN or ITIN will be used for purposes of identification), mailing address, and daytime telephone number and email address; and
(2) Documentation that the applicant meets requirements of section 30315.52(b) and (c). If the applicant fails to meet those requirements, the applicant may not perform mammography surveys without the supervision of a mammography medical physicist with current and valid authorization. To reestablish qualifications for renewal of authorization to independently perform mammography surveys, the applicant shall:
(A) For failure to meet section 30315.52(b)(1), obtain a sufficient number of continuing education units to bring their total units up to the required 15 in the previous three years; and
(B) For failure to meet section 30315.52(b)(2), complete a sufficient number of surveys under the direct supervision of a mammography medical physicist to bring their total surveys up to the required three facilities and nine units in the previous 36 months. No more than one survey of a specific facility within a 10-month period or a specific system conducted within a 60 calendar day period may be counted towards the total mammography unit survey requirement.
(d) Authorization to conduct mammography surveys may be revoked, suspended, amended or restricted for any of the following:
(1) Failure to comply with section 30315.52(b) or (c);
(2) Knowingly conducting or performing mammography system evaluations, quality assurance testing evaluations or surveys that cause or would have caused, if not detected, a facility to be in violation of any provision of the Act, any regulation promulgated pursuant to the Act, any provision of the Radiologic Technology Act, as defined in Health and Safety Code section 27, any regulation promulgated pursuant to the Radiologic Technology Act, or any order of the Department;
(3) Knowingly submitting to the Department false, incorrect or fraudulent information;
(4) Failing to inform a facility that a violation of this article has occurred when the medical physicist knows of the violation;
(5) Procuring authorization by fraud, or misrepresentation, or because of mistake; or
(6) Engaging in deliberate misconduct as specified in section 30105.
(e) For purposes of this section:
(1) Receipt of an application pursuant to this section shall be deemed to occur on the date the application, information, or documents are received by the Department;
(2) An application is considered acceptable when all documents and information required to be submitted on or with the application have been received by the Department, so as to allow the Department to determine if the applicant meets the eligibility requirements pursuant to subsection (a); and
(3) Written notification by the Department to applicants shall be deemed to occur on the date the notifications are postmarked, or if electronically received, date of receipt as indicated on the electronic communication.
(f) Within 30 calendar days of receipt of an application for or renewal of authorization, the Department shall:
(1) Notify the applicant that the application is acceptable; or
(2) Notify the applicant that the application is not acceptable and identify what is required for the Department to consider it acceptable.
(g) Unless the applicant responds to the notification in subsection (f)(2) within 30 calendar days, the application shall be deemed withdrawn.
(h) Within 30 calendar days of receipt of an acceptable application, the Department shall issue or deny the authorization.
(i) Any applicant deemed by the Department to have withdrawn an application pursuant to subsection (g) may reapply by submitting a new application.

Cal. Code Regs. Tit. 17, § 30315.60

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 (a)(4), 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).

Note: Authority cited: Sections 114975, 115060, 115100 and 131200, Health and Safety Code. Reference: Sections 115060, 115100, 131050 and 131051, Health and Safety Code.

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 (a)(4), 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).