California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 5 - California Prenatal Screening Program › Article 5 - Requirements for State-Approved Comprehensive and Satellite Prenatal Diagnosis Centers and Laboratories to Perform Follow-up Services › Section 6542 - Requirements for Approval as a State-Approved Satellite Prenatal Diagnosis Center

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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) An Application Coversheet for each proposed
						Satellite Prenatal Diagnosis Center site that includes:
(A) The date the application was
						completed.
(B) The name of the
						State-Approved Comprehensive Prenatal Diagnosis Center, or Comprehensive Prenatal
						Diagnosis Center Applicant.
(C) Name of
						the Prenatal Diagnosis Center Director.
(D) The proposed name of the Satellite Prenatal
						Diagnosis Center, its organizational ownership, and any organizational unit and/or
						medical group affiliation.
(E) The
						physical location, the mailing address, telephone and facsimile numbers of the site
						of the proposed Satellite Prenatal Diagnosis Center.
(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.
(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.
(H) An affirmation that an Internal Continuous
						Quality Improvement Program description and a copy of the Ultrasound Accreditation
						Certificate are attached to the application.
(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. The full name of the Laboratory
						Director.
2. The Clinical Laboratory
						Improvement Amendments (CLIA) certificate number.
3. The California Laboratory License
						number.
4. The physical location,
						telephone and facsimile numbers.
5. The
						full names and California License numbers for each of the Clinical Cytogeneticists
						employed by each facility.
(J)
						The full names of each of the following designated Clinical Staff Members:
1. Clinical Geneticist(s).
2. Amniocentesis Practitioner(s), and Interim
						Approval Amniocentesis Practitioner(s), if applicable.
3. Transcervical Chorionic Villus Sampling
						Practitioner(s) and Interim Approval Transcervical Chorionic Villus Sampling
						Practitioner(s), if applicable.
4.
						Transabdominal Chorionic Villus Sampling Practitioner(s) and Interim Approval
						Transabdominal Chorionic Villus Sampling Practitioner(s), if applicable.
5. Consultative Sonologist(s).
6. Genetic
						Counselor(s).