1. (a) A facility seeking approval as a State-approved Comprehensive Prenatal Diagnosis Center shall submit an application. Each application shall contain the following:

   1. (1) An Application Coversheet that includes:

      1. (A) The date the application was completed.
      2. (B) The proposed name of the Center, organizational ownership, and any organizational unit and/or medical group affiliation.
      3. (C) Center's physical location, the mailing address, and telephone and facsimile numbers.
      4. (D) Genetic counseling services' physical location, the mailing address, and telephone and facsimile numbers.

      5. (E) The full name, mailing address, telephone number, facsimile number, and email address of the individual(s) designated by the Applicant to be:

         Director of the proposed Comprehensive Prenatal Diagnosis Center;

         Prenatal Diagnosis Center Contact Person for mailings and distributions;

         Back-up Prenatal Diagnosis Center Contact Person; and,

         Quarterly Report Contact Person.

      6. (F) The mailing address, telephone and facsimile numbers for mailing and distribution of Result Mailers from the Department's Screening Information System.
      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 name of the laboratory, or laboratories, authorized by the Department and to be utilized by the Applicant for the performance of prenatal cytogenomic and/or cytogenetic tests, the full name of the Director of each laboratory, the Clinical Laboratory Improvement Amendments (CLIA) certificate number, California Laboratory License number, the physical location, telephone number, and facsimile number of each laboratory, and the full names and California Laboratory License number for each Clinical Cytogeneticist 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) A Director's Agreement that includes:

      1. (A) An affirmation by the designated Director that the statements contained in the application are true and complete to the best of the Applicant's knowledge, and that the designated Director will, as a condition of Comprehensive Prenatal Diagnosis Center approval, comply with the provisions of the Prenatal Diagnosis Center Standards and Definitions 2022, incorporated by reference, and:

         1. 1. Be responsible for the supervision and the quality of testing, counseling, and medical care provided by all clinical members of the State-approved Comprehensive Prenatal Diagnosis Center staff, including at any and all State-approved Satellite Prenatal Diagnosis Centers.
         2. 2. Ensure that all clients have appropriate, non-directive genetic counseling with thorough discussions of the risks of any prenatal diagnostic procedure or other testing to be performed, the chances of an abnormal outcome, and the available options if the results are abnormal.
         3. 3. Ensure that participation in prenatal diagnostic procedures or other testing by any pregnant woman is voluntary, and ensure a signed copy of any State-approved consent form is obtained from each patient prior to any prenatal diagnostic procedure or other testing.
         4. 4. Notify the Genetic Disease Screening Program within 10 calendar days of any case of maternal mortality.
         5. 5. Accept referrals for prenatal diagnostic procedures and for all pregnant women from State funded or administered programs.
         6. 6. Be responsible for overseeing the submission of quarterly reports, data for Adverse Outcome studies, and annual and other reports to the Department, as required by regulation and the Prenatal Diagnosis Center Standards and Definitions 2022, incorporated by reference.
         7. 7. Participate in and successfully complete any State provided or approved site visit, laboratory inspection, proficiency testing, and/or quality control program.
         8. 8. Ensure appropriate supervision of trainees or Genetic Counselors performing genetic counseling with a temporary license.
         9. 9. Ensure that an interdisciplinary meeting is held at least once every three months. This meeting shall include the State-approved Consultative Sonologist(s), Amniocentesis Practitioner(s), Interim Approval Amniocentesis Practitioner(s), Transcervical Chorionic Villus Sampling Practitioner(s), Interim Approval Transcervical Chorionic Villus Sampling Practitioner(s), Transabdominal Chorionic Villus Sampling Practitioner(s), Interim Approval Transabdominal Chorionic Villus Sampling Practitioner(s), Genetic Counselor(s), and Clinical Geneticist(s).
         10. 10. Ensure that at all State-approved Satellite Prenatal Diagnosis Centers, the designated Clinical Geneticist conducts monthly meetings that include case review with the clinical staff who are assigned to the site.
         11. 11. Ensure that whenever chorionic villus sampling is offered, and either transabdominal or transcervical chorionic villus sampling is clinically contraindicated or unsuccessful, and the alternative prenatal diagnostic procedure is not available at the State-approved Comprehensive or any State-approved Satellite Prenatal Diagnosis Center, a referral is made to another State-approved Comprehensive or Satellite Prenatal Diagnosis Center.
         12. 12. Provide oversight to continuous quality improvement and work with staff to achieve improvement goals.
         13. 13. Ensure the Genetic Disease Screening Program of the Department is notified in writing within 10 calendar days of any changes (resignations, discharges and/or additions) in personnel, location, organizational ownership, any organizational unit and/or medical group affiliation, or any other items required for compliance with the Prenatal Diagnosis Center Standards and Definitions 2022, incorporated by reference. The notification shall state any changes which result in noncompliance with the requirements of the Prenatal Diagnosis Center Standards and Definitions 2022. Failure to state such changes will result in the Department's suspension of the State-approved Comprehensive or Satellite Prenatal Diagnosis Center.
         14. 14. Ensure a plan addressing such deficiency or noncompliance, pursuant to subsection (a)(2)(A)14 of this section, is developed and submitted to the Department within 30 calendar days upon receipt of such written notification.
         15. 15. Acknowledge that failure to submit a satisfactory plan to resolve deficiencies, or failure to satisfactorily resolve deficiencies within an additional 60 calendar days, if an extension of the suspension is granted, will result in approval being revoked for the State-approved Comprehensive or Satellite Prenatal Diagnosis Center.
      2. (B) Be responsible for all information contained in the application, and acknowledging that the signed Agreement is a public document and that providing fraudulent information shall be cause for the Department to refuse or revoke approval of the State-approved Comprehensive and/or any Satellite Prenatal Diagnosis Center(s).
      3. (C) The name of the proposed Comprehensive Prenatal Diagnosis Center.
      4. (D) The names of any proposed Satellite Prenatal Diagnosis Centers.
      5. (E) The designated Director's full name, title, signature and date of signing.

   3. (3) Clinical Geneticist Statement(s). Each Clinical Geneticist shall submit a statement that must:

      1. (A) Affirm the designated Clinical Geneticist will be responsible for the supervision of all professional services and for the evaluation of work performance by reviewing and signing off on all patient charts within 30 calendar days of the date of service.
      2. (B) Affirm the designated Clinical Geneticist will be available to provide consultation in person to all families with abnormal or questionable results and will conduct monthly meetings with clinical staff who are assigned to the State-approved Comprehensive and/or Satellite Prenatal Diagnosis Center to include, but not be limited to, case review.
      3. (C) Affirm the designated Clinical Geneticist is certified by the American Board of Medical Genetics and Genomics (ABMGG) in Clinical Genetics, or has Active Candidate status for the next ABMGG examination in Clinical Genetics. Documentation of Active Candidate status must be submitted to the Department. The designated Clinical Geneticist must maintain Active Candidate status or otherwise meet ABMGG certification requirements in order to continue to provide clinical geneticist services.
      4. (D) State the name and location of each proposed Comprehensive and/or Satellite Prenatal Diagnosis Center at which the designated Clinical Geneticist agrees to provide clinical geneticist services.
      5. (E) Affirm the designated Clinical Geneticist has read the Prenatal Diagnosis Center Standards and Definitions 2022, incorporated by reference, and agrees to comply with the requirements in the document.
      6. (F) Include the designated Clinical Geneticist's full name, signature, and date of signing.
      7. (G) Include the designated Clinical Geneticist's California Medical License Number.
      8. (H) Include the designated Director's full name, signature and date of signing, if the designated Clinical Geneticist is not the designated Director.

   4. (4) Amniocentesis Practitioner Statement(s). Each Amniocentesis Practitioner Statement must:

      1. (A) Indicate whether the practitioner has received prior approval from the Department as an Amniocentesis Practitioner or Interim Approval Amniocentesis Practitioner, or is applying for approval as a new Amniocentesis Practitioner or new Interim Approval Amniocentesis Practitioner.
      2. (B) Affirm the designated practitioner has the training and experience with second trimester ultrasound-guided amniocentesis, obstetrical ultrasonography, and counseling for chromosomal, biochemical, and neural tube defects required for that practitioner category, as outlined in the Prenatal Diagnosis Center Standards and Definitions 2022, incorporated by reference.
      3. (C) Affirm the designated practitioner will collect data for Adverse Outcome studies as outlined in the Prenatal Diagnosis Center Standards and Definitions 2022, incorporated by reference.
      4. (D) State the name and location of each proposed Comprehensive and/or Satellite Prenatal Diagnosis Center at which the designated practitioner agrees to provide amniocentesis services.
      5. (E) Affirm the designated practitioner has read and agrees to comply with requirements in the Prenatal Diagnosis Center Standards and Definitions 2022, incorporated by reference.
      6. (F) Include the designated practitioner's full name, signature and date of signing.
      7. (G) Include the designated practitioner's California Medical License Number.
      8. (H) Include the designated Director's full name, signature and date of signing.

      9. (I) Include, for new Amniocentesis Practitioner or Interim Approval Amniocentesis Practitioner Applicants that have not received prior approval from the Department as an Amniocentesis Practitioner or Interim Approval Amniocentesis Practitioner:

         1. 1. Whether the Applicant is Board certified or is an Active Candidate for Board certification in Obstetrics and Gynecology, Clinical Genetics, Radiology, and/or in any other specialty.
         2. 2. Whether or not the Applicant has completed a Fellowship in Maternal-Fetal Medicine or Reproductive Genetics.
         3. 3. The total number of supervised second trimester amniocentesis procedures performed by the Applicant.
         4. 4. The facility or facilities where supervised procedures were performed.
         5. 5. The supervisor's or supervisors' name(s) and current address(es).

      10. (J) Include, for new Interim Approval Amniocentesis Practitioner Applicants that have not received prior approval from the Department as an Interim Approval Amniocentesis Practitioner, and for existing Interim Approval Amniocentesis Practitioners being added to the staff:

          1. 1. The Applicant's email address.
          2. 2. The Applicant's fellowship institution and type of training program.
          3. 3. Whether the Applicant is currently in, or the year of completion of, a Maternal-Fetal Medicine or equivalent specialized training program.
          4. 4. A list of the Applicant's designated supervisor(s) at all proposed Comprehensive and/or Satellite Prenatal Diagnosis Center sites. The designated supervising practitioner(s) must meet and adhere to the requirements outlined in the Prenatal Diagnosis Center Standards and Definitions 2022, incorporated by reference.
          5. 5. Documentation from each designated supervising practitioner agreeing to adhere to the supervision requirements outlined in the Prenatal Diagnosis Center Standards and Definitions 2022, incorporated by reference, while the Interim Approval Amniocentesis Practitioner is performing second trimester amniocenteses. If the Interim Approval Amniocentesis Practitioner Applicant has multiple designated supervisors, one letter from a State-approved practitioner who is acknowledged to be a primary supervisor, and listing all designated supervising practitioners, may be included.
          6. 6. An affirmation from the Interim Approval Amniocentesis Practitioner Applicant that the 15 second trimester amniocentesis procedures following interim approval shall be performed with a supervising State-approved Amniocentesis Practitioner present in the room and immediately available to the practitioner during the procedures; and that a log with a participant identifier, the indication for the procedure, the date of the procedure, the gestational age at the time of the procedure, the number of fetuses, the State-approved Comprehensive or Satellite Prenatal Diagnosis Center site number, and the name of the supervising practitioner must be maintained and submitted to the Department every six months and upon completion of the procedures.
          7. 7. An affirmation that the Interim Approval Amniocentesis Practitioner Applicant agrees to comply with the above requirements, and understands that noncompliance will result in the withdrawal of approval.
          8. 8. The Interim Approval Amniocentesis Practitioner Applicant's signature and date of signing.

   5. (5) For an Applicant organization applying for approval to provide optional transcervical chorionic villus sampling services, a Transcervical Chorionic Villus Sampling Practitioner Statement(s) must be included. Each Transcervical Chorionic Villus Sampling Practitioner Statement must:

      1. (A) Indicate whether the practitioner has received, or is applying for, approval from the Department as a Transcervical Chorionic Villus Sampling Practitioner or Interim Approval Transcervical Chorionic Villus Sampling Practitioner.
      2. (B) Affirm the designated practitioner has the training and experience with first trimester transcervical chorionic villus sampling required for that practitioner category, as outlined in the Prenatal Diagnosis Center Standards and Definitions 2022, incorporated by reference.
      3. (C) Affirm the designated practitioner will collect data for Adverse Outcome studies as outlined in the Prenatal Diagnosis Center Standards and Definitions 2022, incorporated by reference.
      4. (D) State the name and location of each proposed Comprehensive and/or Satellite Prenatal Diagnosis Center where the designated practitioner agrees to provide transcervical chorionic villus sampling services.
      5. (E) Affirm the designated practitioner has read and agrees to comply with the requirements in the Prenatal Diagnosis Center Standards and Definitions 2022, incorporated by reference.
      6. (F) Include the designated practitioner's signature, full name, and date of signature.
      7. (G) Include the designated practitioner's California Medical License Number.
      8. (H) Include the designated Director's signature, full name, and date of signature.

      9. (I) Include for new Applicants that have not received prior approval from the Department as Transcervical Chorionic Villus Sampling Practitioners or Interim Approval Transcervical Chorionic Villus Sampling Practitioners:

         1. 1. Whether the Applicant is Board certified or is an Active Candidate for Board certification by the American Board of Obstetrics and Gynecology (ABOG).
         2. 2. If the Applicant is experienced in ultrasound guided amniocentesis.
         3. 3. The total number of first trimester transcervical chorionic villus sampling procedures performed on women not continuing their pregnancies, with the dates between which such procedures were performed.
         4. 4. The total number of supervised first trimester transcervical chorionic villus sampling procedures performed on women continuing their pregnancies, with the dates between which such procedures were performed.
         5. 5. The facility or facilities where supervised transcervical chorionic villus sampling procedures were performed.
         6. 6. The supervisor's or supervisors' name(s) and current address(es).

      10. (J) Include, for Interim Approval Transcervical Chorionic Villus Sampling Practitioner Applicants that have not received prior approval from the Department as an Interim Approval Transcervical Chorionic Villus Sampling Practitioner, and for existing Interim Approval Transcervical Chorionic Villus Sampling Practitioners being added to the staff:

          1. 1. The Applicant's email address.
          2. 2. The Applicant's Fellowship Institution and type of training program.
          3. 3. Whether the Applicant is currently in a Maternal-Fetal Medicine or equivalent specialized training program, or the year of completion of the Maternal-Fetal Medicine or equivalent specialized training program.
          4. 4. A list of the Applicant's designated supervisor(s) at all proposed Comprehensive and/or Satellite Prenatal Diagnosis Centers. The designated supervising practitioner(s) must meet the requirements outlined in the Prenatal Diagnosis Center Standards and Definitions 2022, incorporated by reference.
          5. 5. Documentation from each designated supervising practitioner agreeing to adhere to the supervision requirements outlined in the Prenatal Diagnosis Center Standards and Definitions 2022, incorporated by reference, while the Interim Approval Transcervical Chorionic Villus Sampling Practitioner is performing first trimester transcervical chorionic villus sampling. If the Interim Approval Transcervical Chorionic Villus Sampling Practitioner Applicant has multiple supervisors, one letter from a State-approved practitioner who is acknowledged to be a primary supervisor, and listing all designated supervising practitioners, may be included.
          6. 6. An affirmation from the Interim Approval Transcervical Chorionic Villus Sampling Practitioner Applicant that the 13 first trimester transcervical chorionic villus sampling procedures following interim approval shall be performed with a supervising State-approved Transcervical Chorionic Villus Sampling Practitioner in the room and immediately available to the practitioner during the procedures; and that a log with a participant identifier, the indication for the procedure, the date of the procedure, the gestational age at the time of the procedure, the number of fetuses, the State-approved Comprehensive or Satellite Prenatal Diagnosis Center site number, and the name of the supervising practitioner must be maintained and submitted to the Department every six (6) months and upon completion of the procedures.
          7. 7. An affirmation that the Interim Approval Transcervical Chorionic Villus Sampling Practitioner Applicant agrees to comply with the above requirements, and understands that noncompliance will result in the withdrawal of approval.
          8. 8. The Interim Approval Transcervical Chorionic Villus Sampling Practitioner Applicant's signature and date of signing.

   6. (6) For an Applicant organization applying for approval to provide optional transabdominal chorionic villus sampling services, a Transabdominal Chorionic Villus Sampling Practitioner Statement(s) must be included. Each Transabdominal Chorionic Villus Sampling Practitioner Statement must:

      1. (A) Indicate whether the practitioner has received prior, or is applying for, approval from the Department as a Transabdominal Chorionic Villus Sampling Practitioner or Interim Approval Transabdominal Chorionic Villus Sampling Practitioner.
      2. (B) Affirm the designated practitioner has the training and experience with transabdominal chorionic villus sampling required for that practitioner category, as outlined in the Prenatal Diagnosis Center Standards and Definitions 2022, incorporated by reference.
      3. (C) Affirm the designated practitioner will collect data for Adverse Outcome studies as outlined in the Prenatal Diagnosis Center Standards and Definitions 2022, incorporated by reference.
      4. (D) State the name and location of each Comprehensive and/or Satellite Prenatal Diagnosis Center site at which the designated practitioner agrees to provide transabdominal chorionic villus sampling services.
      5. (E) Affirm the designated practitioner has read and agrees to comply with the requirements in the Prenatal Diagnosis Center Standards and Definitions 2022, incorporated by reference.
      6. (F) Include the designated practitioner's signature, full name, and date of signing.
      7. (G) Include the designated practitioner's California Medical License Number.
      8. (H) Include the designated Director's signature, full name, and date of signing.

      9. (I) Include, for new Applicants that have not received prior approval from the Department as a Transabdominal Chorionic Villus Sampling Practitioner or Interim Approval Transabdominal Chorionic Villus Sampling Practitioner:

         1. 1. Whether the Applicant is certified or is an active candidate for certification by the ABOG.
         2. 2. Whether or not the Applicant is approved by the Department as an Amniocentesis Practitioner, or is experienced in amniocentesis.
         3. 3. Whether the Applicant is approved by, or is concurrently applying for approval by, the Department as a Transcervical Chorionic Villus Sampling Practitioner.
         4. 4. The total number of first trimester transabdominal chorionic villus sampling procedures performed on women not continuing their pregnancies, with the dates between which such procedures were performed.
         5. 5. The total number of supervised first trimester transabdominal chorionic villus sampling procedures performed on women continuing their pregnancies, with the dates between which such procedures were performed.
         6. 6. The facility or facilities where supervised first trimester transabdominal chorionic villus sampling procedures were performed.
         7. 7. The supervisor's or supervisors' name(s) and current address(es).

      10. (J) Include, for new Interim Approval Transabdominal Chorionic Villus Sampling Practitioner Applicants that have not received prior approval from the Department as an Interim Approval Transabdominal Chorionic Villus Sampling Practitioner, and for existing Interim Approval Transabdominal Chorionic Villus Sampling Practitioner being added to the staff:

          1. 1. The Applicant's email address.
          2. 2. The Applicant's Fellowship Institution and type of training program.
          3. 3. Whether the Applicant is currently in, or the year of completion of, a Maternal-Fetal Medicine or equivalent specialized training program.
          4. 4. A list of the Applicant's designated supervisor(s) at all Prenatal Diagnosis Center sites. The designated supervising practitioner(s) must meet the requirements outlined in the Prenatal Diagnosis Center Standards and Definitions 2022, incorporated by reference.
          5. 5. Documentation from each designated supervising practitioner agreeing to adhere to the supervision requirements outlined in the Prenatal Diagnosis Center Standards and Definitions 2022, incorporated by reference, while the Interim Approval Transabdominal Chorionic Villus Sampling is performing first trimester chorionic villus sampling. If the Interim Approval Transabdominal Chorionic Villus Sampling Practitioner Applicant has multiple supervisors, one letter from a State-approved practitioner who is acknowledged to be a primary supervisor, and listing all designated supervising practitioners, may be included.
          6. 6. An affirmation from the Interim Approval Transabdominal Chorionic Villus Sampling Practitioner Applicant that the 13 first trimester transabdominal chorionic villus sampling procedures following interim approval shall be performed with a supervising State-approved Transabdominal Chorionic Villus Sampling Practitioner in the room and immediately available to the practitioner during the procedures; and that a log with a participant identifier, the indication for the procedure, the date of the procedure, the gestational age at the time of the procedure, the number of fetuses, the Prenatal Diagnosis Center site number, and the name of the supervising practitioner must be maintained and submitted to the Department every six months and upon completion of the procedures.
          7. 7. An affirmation that the Interim Approval Transabdominal Chorionic Villus Sampling Practitioner Applicant agrees to comply with the above requirements, and understands that noncompliance will result in the withdrawal of approval.
          8. 8. The Interim Approval Transabdominal Chorionic Villus Sampling Practitioner Applicant's signature and date of signing.

   7. (7) A Consultative Sonologist Practitioner Statement(s). Each Consultative Sonologist Practitioner Statement must:

      1. (A) Indicate whether the practitioner has received prior approval from the Department as a Consultative Sonologist Practitioner, or is applying for approval as a new Consultative Sonologist Practitioner.
      2. (B) Affirm the designated practitioner has had training and is experienced in the ultrasonographic detection of fetal abnormalities as outlined in the Prenatal Diagnosis Center Standards and Definitions 2022, incorporated by reference.
      3. (C) Affirm the designated practitioner is part of a practice that is accredited by the American College of Radiology or the American Institute of Ultrasound in Medicine, and that the accreditation covers the proposed Comprehensive and/or Satellite Prenatal Diagnosis Centers listed in the Statement.
      4. (D) State the name and location of each proposed Comprehensive and/or Satellite Prenatal Diagnosis Center at which the designated practitioner agrees to provide consultative ultrasonography services.
      5. (E) Affirm the designated practitioner has read and agrees to comply with the requirements in the Prenatal Diagnosis Center Standards and Definitions 2022, incorporated by reference.
      6. (F) Include the designated practitioner's signature, full name, and date of signing.
      7. (G) Include the designated practitioner's California Medical License Number.
      8. (H) Include the designated Director's signature, full name, and date of signing.
      9. (I) Indicate whether the designated practitioner is covered by an Ultrasound Practice Accreditation by the American College of Radiology or the American Institute of Ultrasound in Medicine, and include the Accreditation Number.

      10. (J) Include, for new Consultative Sonologist Practitioner Applicants that have not received prior approval from the Department as a Consultative Sonologist Practitioner:

          1. 1. Whether the Applicant is Board certified or an Active Candidate for Board certification in Obstetrics and Gynecology, Clinical Genetics, Radiology, and/or in any other specialty.
          2. 2. A copy of the Applicant's curriculum vitae.
          3. 3. Whether or not the Applicant has completed a Fellowship in Maternal-Fetal Medicine in a facility that performs at least 2,000 second trimester fetal ultrasound exams each year, and where the fellowship was completed.
          4. 4. Whether or not the Applicant has completed a Fellowship in Clinical Genetics with an emphasis upon fetal medicine in a facility that performs at least 2,000 second trimester fetal ultrasound exams each year, and where the fellowship was completed.
          5. 5. Whether or not the Applicant has completed a Fellowship in diagnostic radiology, body imaging, or the equivalent with an emphasis upon fetal medicine in a facility that performs at least 2,000 second trimester fetal ultrasound exams per year, and where the fellowship was completed.
          6. 6. Whether or not the Applicant has completed training, either as supplemental training or part of a fellowship, at a facility that performs at least 2,000 second trimester fetal ultrasound exams a year, and the name of the facility where any such training was completed. The training must have included at least three (3) months of targeted fetal ultrasound examinations that involve high-risk obstetric imaging and must include basic physics, techniques, performance, and interpretation followed by three (3) months of proctoring by a qualified consultative sonologist.
          7. 7. The number of detailed second trimester ultrasound examinations performed by the Applicant specifically for the detection of fetal abnormalities. Indications may include twins, early growth delay, oligohydramnios, polyhydramnios, abnormality observed at another facility, history of genetically transmitted disease, insulin dependent diabetes, family history of malformation and advanced maternal age. Detailed second trimester ultrasound examinations must have included: fetal number, fetal presentation, documentation of fetal life, placental localization, amniotic fluid volume, gestational dating, detection and evaluation of maternal pelvic mass, and a survey of fetal anatomy for malformations.

   8. (8) A Genetic Counselor Statement(s). Each Genetic Counselor Statement must:

      1. (A) Affirm the designated Genetic Counselor has a Genetic Counselor License or temporary Genetic Counselor License issued by the Department.
      2. (B) State the name and location of each proposed Comprehensive and/or Satellite Prenatal Diagnosis Center at which the designated Genetic Counselor agrees to provide genetic counseling services.
      3. (C) Affirm the designated Genetic Counselor has read and agrees to comply with the requirements in the Prenatal Diagnosis Center Standards and Definitions 2022, incorporated by reference.
      4. (D) Include the designated Genetic Counselor's signature, full name, and date of signing.
      5. (E) Include the designated Genetic Counselor's California License Number.
      6. (F) Include the designated Director's signature, full name, and date of signing.

   9. (9) A Laboratory Director Statement from each laboratory approved by the Department to perform follow-up services and to be utilized by the Applicant for prenatal cytogenomic and/or cytogenetic tests. Each Laboratory Director Statement must:

      1. (A) Affirm the Laboratory Director is a physician or holds a doctorate degree, has training and experience as a Clinical Cytogeneticist directing a prenatal diagnosis cytogenetics laboratory, and is certified by the American Board of Medical Genetics and Genomics or Canadian College of Medical Genetics in Clinical Cytogenetics.
      2. (B) State the name and address of the laboratory.
      3. (C) Include the CLIA certificate number and the California Laboratory License number of the laboratory.
      4. (D) Indicate the cytogenomic and/or cytogenetic tests the designated Laboratory Director is agreeing to provide for the proposed Comprehensive and/or Satellite Prenatal Diagnosis Centers listed.
      5. (E) State the names of each proposed Comprehensive and/or Satellite Prenatal Diagnosis Center for which the Laboratory Director agrees to provide cytogenomic and/or cytogenetic tests.
      6. (F) Affirm the Laboratory Director has read and agrees to comply with the requirements in the Prenatal Diagnosis Center Standards and Definitions 2022, incorporated by reference.
      7. (G) Include the Laboratory Director's signature, full name, and date of signing.
      8. (H) Include the Laboratory Director's California License Number.
      9. (I) Include the signature, date of signing and full name of the designated Director of the proposed Comprehensive Prenatal Diagnosis Center.

   10. (10) A Clinical Schedule and Staff Coverage Statement that indicates the date completed, and, for each proposed Comprehensive and Satellite Prenatal Diagnosis Center:

       1. (A) The name of the proposed Comprehensive or Satellite Prenatal Diagnosis Center.
       2. (B) The telephone number to call for appointments.
       3. (C) The name of a designated Appointment Scheduler.
       4. (D) A secured facsimile number.
       5. (E) How often is the clinic held.
       6. (F) The name of each designated Clinical Geneticist, Amniocentesis Practitioner, Interim Approval Amniocentesis Practitioner, Transcervical Chorionic Villus Sampling Practitioner, Interim Approval Transcervical Chorionic Villus Sampling Practitioner, Transabdominal Chorionic Villus Sampling Practitioner, Interim Approval Transabdominal Chorionic Villus Sampling Practitioner, Consultative Sonologist, and Genetic Counselor, and the days and times of the week they will provide services.
   11. (11) An Internal Continuous Quality Improvement Program description.
   12. (12) A copy of the Ultrasound Accreditation Certificate.
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 shall cause the Department to consider the application withdrawn. The Applicant shall remain eligible to reapply for authorization as a State-approved Comprehensive Prenatal Diagnosis Center.
7. (g) If there are no findings of deficiency during the site visit, or if any findings are successfully complied with or resolved, the Department shall notify the Applicant of approval to enter into a contract with the Department as a State-approved Comprehensive Prenatal Diagnosis Center.

8. (h) Upon execution of the contract, the applicant shall be notified. Approval to provide authorized follow up services may only be offered to California Prenatal Screening Program referrals upon execution of a contract with the department. At least seven (7) calendar days within the date of notification the following information shall be submitted by the applicant:

   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.
9. (i) Failure to provide written confirmation that there are no changes from the information on the application within 30 calendar days of the notification shall cause the Department to consider the application withdrawn.
10. (j) 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.
11. (k) If the State-approved Comprehensive 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 Comprehensive 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 article 5 (sections 6541-6549) and 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 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 refiled 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.

5. Amendment of subsections (a)(1)(F), (a)(4)(J)6., (a)(5)(J)6. and (a)(6)(J)6. filed 4-3-2024 as an emergency; operative 4-3-2024 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 (Register 2024, No. 14). Pursuant to Health and Safety Code section 124977(d)(2), these regulations shall remain in effect until revised or repealed by the department.

6. Statement of Compliance pursuant to Health and Safety Code section 124977(d) as to 4-3-2024 order filed 10-17-2024. Exempt from OAL review pursuant to Health and Safety Code section 124977(d). Submitted to OAL for filing and printing only pursuant to Government Code sections 11343.8 (Register 2024, No. 42).