1. (a) A State-approved Comprehensive Prenatal Diagnosis Center, or Comprehensive Prenatal Diagnosis Center Applicant, seeking Departmental approval to operate a State-approved Satellite Prenatal Diagnosis Center(s) shall submit an application to the Department. Each application shall contain the following to demonstrate the proposed Satellite Prenatal Diagnosis Center(s) has the capacity to meet the Prenatal Diagnosis Center Standards and Definitions 2022, incorporated by reference:

   1. (1) An Application Coversheet for each proposed Satellite Prenatal Diagnosis Center site that includes:

      1. (A) The date the application was completed.
      2. (B) The name of the State-Approved Comprehensive Prenatal Diagnosis Center, or Comprehensive Prenatal Diagnosis Center Applicant.
      3. (C) Name of the Prenatal Diagnosis Center Director.
      4. (D) The proposed name of the Satellite Prenatal Diagnosis Center, its organizational ownership, and any organizational unit and/or medical group affiliation.
      5. (E) The physical location, the mailing address, telephone and facsimile numbers of the site of the proposed Satellite Prenatal Diagnosis Center.
      6. (F) The physical location, the mailing address, telephone and facsimile numbers where genetic counseling services are to be provided, if different from the above address.
      7. (G) The name of the ultrasound practice, the ultrasound practice's American Institute of Ultrasound in Medicine or American College of Radiology accreditation number and expiration date, the physical location where ultrasounds are to be performed, the telephone number, and facsimile number. If amniocentesis and/or chorionic villus sampling procedures are to be performed at a different location, the physical location, telephone number, and facsimile number of that location must also be provided.
      8. (H) An affirmation that an Internal Continuous Quality Improvement Program description and a copy of the Ultrasound Accreditation Certificate are attached to the application.

      9. (I) The following information for each laboratory approved by the Department for follow-up services and to be utilized by the proposed Satellite Prenatal Diagnosis Center for cytogenomic and/or cytogenetic tests:

         1. 1. The full name of the Laboratory Director.
         2. 2. The Clinical Laboratory Improvement Amendments (CLIA) certificate number.
         3. 3. The California Laboratory License number.
         4. 4. The physical location, telephone and facsimile numbers.
         5. 5. The full names and California License numbers for each of the Clinical Cytogeneticists employed by each facility.

      10. (J) The full names of each of the following designated Clinical Staff Members:

          1. 1. Clinical Geneticist(s).
          2. 2. Amniocentesis Practitioner(s), and Interim Approval Amniocentesis Practitioner(s), if applicable.
          3. 3. Transcervical Chorionic Villus Sampling Practitioner(s) and Interim Approval Transcervical Chorionic Villus Sampling Practitioner(s), if applicable.
          4. 4. Transabdominal Chorionic Villus Sampling Practitioner(s) and Interim Approval Transabdominal Chorionic Villus Sampling Practitioner(s), if applicable.
          5. 5. Consultative Sonologist(s).
          6. 6. Genetic Counselor(s).
   2. (2) The information required for Comprehensive Prenatal Diagnosis Center Applicants outlined in section 6541 (a) (1) through (13) of this Article. Information should be submitted for all Centers for which approval is sought, including all Satellite Prenatal Diagnosis Centers.

   3. (3) An Agreement between a State-approved Comprehensive Prenatal Diagnosis Center or Comprehensive Prenatal Diagnosis Center Applicant and each proposed Satellite Prenatal Diagnosis Center. Each Agreement must:

      1. (A) Include the names of the proposed Satellite Prenatal Diagnosis Center site and the Comprehensive Prenatal Diagnosis Center.
      2. (B) Affirm that the proposed Satellite Prenatal Diagnosis Center site has a formal agreement with the Comprehensive Prenatal Diagnosis Center.
      3. (C) Affirm that the State-approved Comprehensive Prenatal Diagnosis Center will be responsible for compliance with the Prenatal Diagnosis Center Standards and Definitions 2022, incorporated by reference, including the provision of quality diagnostic procedures, genetic counseling, ultrasound and prenatal specimen testing by a laboratory approved by the Department to perform follow-up services.
      4. (D) Include the name and location of the laboratory to be utilized by the proposed Satellite Prenatal Diagnosis Center to perform cytogenomic and/or cytogenetic tests.
      5. (E) Affirm that if services are to be provided in a licensed hospital, designated practitioners at the proposed Satellite Prenatal Diagnosis Center have staff privileges and/or are authorized to use inpatient or outpatient hospital-operated facilities.
      6. (F) Include the full name, signature and date of signing by the Administrator of the proposed Satellite Prenatal Diagnosis Center, or name of other appropriate representative.
      7. (G) Include the full name, signature, and date of signing by the Director or designated Director of the Comprehensive Prenatal Diagnosis Center.
2. (b) If an incomplete application is received, the Applicant shall be notified and have 30 calendar days from the date of notification by the Department to complete the application process, including the submission of support documentation.
3. (c) Applicant will be notified by the Department of the receipt of a complete application.
4. (d) Following receipt and review of a completed application, the Department will conduct a site visit.
5. (e) If there are findings of deficiencies during the Department's site visit, the Applicant will be notified of the findings and have 30 calendar days following notification to successfully comply with or resolve any findings.
6. (f) Failure to meet any requirements of this Section will cause the Department to consider the application withdrawn. The Applicant remains eligible to reapply for authorization of the State-approved Satellite Prenatal Diagnosis Center.

7. (g) If there are no findings during the site visit, or if any findings are successfully complied with or resolved, the Department shall request that the following information be submitted by the applicant within seven (7) calendar days of the date of the notification:

   1. (1) The Applicant must confirm the information provided in the original application remains unchanged. If there are any changes in location or the personnel, the applicant must submit changes by submitting the documentation as stated in section 6541 (a) (1) through (13) of this Article.

   2. (2) The Applicant must confirm in writing the full names and emails of the staff members designated to be responsible for each of the following functions in the Department's Screening Information System (SIS), with a statement of whether each person has or needs access to the Department's Screening Information System:

      1. (A) Appointment Scheduler(s).
      2. (B) Patient Service Reports Contact(s).
      3. (C) Invoice Liaison(s).
   3. (3) If a staff member is designated to perform multiple functions, that person's name should be listed under each function. The names, emails, and functions of any additional staff members requiring access to the Screening Information System must also be provided. Each staff member requiring access to the Screening Information System must sign and submit a copy of the Screening Information System Oath of Confidentiality.
8. (h) Failure to provide confirmation within 30 calendar days of the notification shall cause the Department to consider the application withdrawn.
9. (i) Upon written confirmation that there are no changes from the application or to the names, emails, and Oath of Confidentiality of the staff members requiring access to the Department's Screening Information System (SIS), the Department shall notify the applicant of the date from which they may offer authorized follow up services to California Prenatal Screening Program referrals. The approval shall be valid only in the location stated and with the personnel listed, and shall be subject to any conditions stated by the Department.
10. (j) If the State-approved Satellite Prenatal Diagnosis Center is not operational and able to schedule California Prenatal Screening Program referrals for authorized follow-up services within 30 calendar days following the date of the approval by the Department, approval as a State-approved Satellite Prenatal Diagnosis Center will be withdrawn by the Department.

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) and (a)(3)(C) 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) and (a)(3)(C) 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.