1. (a) Continued approval as a State-Approved Comprehensive Prenatal Diagnosis Center or State-Approved Satellite Prenatal Diagnosis Center is dependent on compliance with the regulations set forth herein and the provisions of the Prenatal Diagnosis Center Standards and Definitions 2022, incorporated by reference.
2. (b) Any changes in personnel or in the location(s) where services are provided may render the approval void. If there are any changes in the location(s) where services are provided, the staffing, or providers of follow-up services, the Director of the State-approved Comprehensive Prenatal Diagnosis Center must notify the Department within 10 calendar days and submit documentation of any new clinical staff or providers of follow-up services for approval, verifying they meet the requirements of the Prenatal Diagnosis Center Standards and Definitions 2022, incorporated by reference. If there are no findings of deficiencies, or if any findings of deficiencies are successfully complied with or resolved, the Department shall notify the Applicant of continued approval of the State-approved Comprehensive Prenatal Diagnosis Center and any Satellite Prenatal Diagnosis Centers. The approval shall be valid only in the location(s) stated and with the personnel listed, and shall be subject to any conditions stated in the Department notification.

3. (c) Before the end of each calendar year, the Department will provide to the State-approved Comprehensive Prenatal Diagnosis Center a list of site names, addresses, phone and facsimile numbers, any approval conditions, and the clinical staff approved to provide services at the State-Approved Comprehensive Prenatal Diagnosis Center and any State-Approved Satellite Prenatal Diagnosis Centers. The State-approved Comprehensive Prenatal Diagnosis Center must review the conditions of approval, submit requested information, and review the personnel listings for accuracy. Within 30 calendar days after receiving this information from the Department, the State-approved Comprehensive Prenatal Diagnosis Center must submit the following documentation:

   1. (1) An Annual Reporting Coversheet that includes:

      1. (A) The name of the person submitting the documentation.
      2. (B) The date the submission was completed.

      3. (C) For the State-approved Comprehensive Prenatal Diagnosis Center site, the following clinical services information:

         1. 1. The name of the State-approved Comprehensive Prenatal Diagnosis Center.
         2. 2. The physical location where genetic counseling services are provided, and the telephone number and facsimile number of that location.
         3. 3. The name of the ultrasound practice, the American Institute of Ultrasound in Medicine/American College of Radiology accreditation number and expiration date, and the physical location, telephone number, and facsimile number of the location where ultrasound services are performed.

         4. 4. The number of the following from November 1 of the prior year to October 31 of the current year, including California Prenatal Screening Program referrals:

            1. i. Amniocentesis procedures performed.
            2. ii. Chorionic villus sampling procedures performed.
            3. iii. Women seen for prenatal genetic services. (If a State-approved Comprehensive Prenatal Diagnosis Center has not seen the minimum annual volume of 100 patients for genetic counseling, a letter of justification for maintaining approval must be submitted to the Department.)

         5. 5. The full name, mailing address, telephone and facsimile numbers, and email address of the following personnel at the State-approved Comprehensive Prenatal Diagnosis Center:

            1. i. Director.
            2. ii. Contact Person.
            3. iii. Back-up Contact Person.

         6. 6. For each laboratory authorized by the Department and utilized by the State-approved Comprehensive Prenatal Diagnosis Center for cytogenomic and/or cytogenetic tests, provide the following:

            1. i. Laboratory name.
            2. ii. Full name of the Laboratory Director.
            3. iii. California License number for Laboratory Director.
            4. iv. Physical location.
            5. v. Full names for each of the Clinical Cytogeneticists employed.
            6. vi. California License number for each of the Clinical Cytogeneticists employed.

      4. (D) For each State-approved Satellite Prenatal Diagnosis Center, the following clinical services information:

         1. 1. The name and Department-assigned code of the State-approved Satellite Prenatal Diagnosis Center.
         2. 2. The physical location where genetic counseling services are provided, and the telephone number and facsimile number of that location.
         3. 3. The name of the ultrasound practice, and the American Institute of Ultrasound in Medicine/American College of Radiology accreditation number and expiration date, and the physical location where ultrasound services are performed.

         4. 4. The number of the following from November 1 of the prior year to October 31 of the current year, including California Prenatal Screening Program referrals:

            1. i. Amniocentesis procedures performed.
            2. ii. Chorionic villus sampling procedures performed.
            3. iii. Women seen for prenatal genetic services. (If a State-approved Satellite Prenatal Diagnosis Center has not seen the minimum annual volume of 100 patients for genetic counseling, a letter of justification for maintaining approval must be submitted to the Department.)
   2. (2) Statistics for each approved Amniocentesis Practitioner, Interim Approval Amniocentesis Practitioner, Transabdominal Chorionic Villus Sampling Practitioner, Interim Approval Transabdominal Chorionic Villus Sampling Practitioner, Transcervical Chorionic Villus Sampling Practitioner, Interim Approval Transcervical Chorionic Villus Sampling Practitioner, and Consultative Sonologist for procedures performed from November 1 of the prior year to October 31 of the current year, including California Prenatal Screening Program referrals. For Amniocentesis Practitioners and Interim Approval Amniocentesis Practitioners, only procedures performed prior to 24 weeks gestational age should be reported. For Consultative Sonologists, only examinations performed after 15 weeks gestational age should be reported. Procedures included should be restricted to those performed at the State-approved Comprehensive Prenatal Diagnosis Center and any State-approved Satellite Prenatal Diagnosis Centers, unless a Practitioner has not performed enough procedures to meet the minimum requirements of the Prenatal Diagnosis Centers Standards and Definitions 2022, incorporated by reference, but performs procedures at other non-State-approved sites. Those procedures may be reported but should be listed separately from the procedures performed at the State-approved Comprehensive and any Satellite Prenatal Diagnosis Centers, and a note of this exception should be made when reporting.
   3. (3) Number of cytogenomic and cytogenetic tests performed by each laboratory approved by the Department to perform follow-up services and ordered by the State-approved Comprehensive Prenatal Diagnosis Center and any State-approved Satellite Prenatal Diagnosis Centers, including for California Prenatal Screening Program referrals, from November 1 of the prior year to October 31 of the current year.
   4. (4) A Director's agreement containing the information outlined in section 6541 (a)(2) of this Article.
   5. (5) A Clinical Staff Schedule containing the information outlined in section 6541 (a)(11) of this Article.
4. (d) If documentation submitted to meet the requirements of subsection (c) is incomplete, the State-approved Comprehensive Prenatal Diagnosis Center shall have seven (7) calendar days to complete the reporting process, including the submission of support documentation, from the date of notification by the Department that additional information is required.
5. (e) If there are findings of deficiencies from documentation submitted to meet the requirements of subsection (c), the State-approved Comprehensive Prenatal Diagnosis Center will be notified of the findings and shall have 30 calendar days from the date of notification by the Department to successfully comply with or resolve any findings of deficiencies.
6. (f) Failure to meet any requirements of this section will cause the Department to consider suspension or revocation of approval.

Note: Authority cited: Sections 124977, 124980, 124996, 125000, 125065 and 131200, Health and Safety Code. Reference: Sections 124975, 124980, 124990, 125000, 125001, 125050, 125055 and 125065, Health and Safety Code.

History

1. New section filed 12-20-2019 as an emergency; operative 12-20-2019 pursuant to Health and Safety Code section 124977(d). Submitted to OAL for filing and printing only pursuant to Health and Safety Code section 124977(d) (Register 2019, No. 51). Pursuant to Health and Safety Code section 124977(d)(2), these regulations shall remain in effect until revised or repealed by the department.

2. Statement of Compliance pursuant to Health and Safety Code section 124977(d)(1) as to 12-20-2019 order filed 12-11-2020. Exempt from OAL review pursuant to Health and Safety Code section 124977(d)(2). Submitted to OAL for filing and printing only pursuant to Government Code section 11343.8 (Register 2020, No. 50).

3. Amendment of subsections (a)-(b) and (c)(2) filed 7-18-2022 as an emergency; operative 7-18-2022 pursuant to Health and Safety Code section 124977(d). Submitted to OAL for filing and printing only pursuant to Health and Safety Code section 124977(d) (Register 2022, No. 29). Pursuant to Health and Safety Code section 124977(d)(2), these regulations shall remain in effect until revised or repealed by the department.

4. Amendment of subsections (a)-(b) and (c)(2) refiled 9-9-2022 as an emergency; operative 9-9-2022 pursuant to Health and Safety Code section 124977(d) (Register 2022, No. 36). Pursuant to Health and Safety Code section 124977(d)(2), these regulations shall remain in effect until revised or repealed by the department.