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 6541 - Requirements for Approval as a State-Approved Comprehensive Prenatal Diagnosis Center

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A facility
						seeking approval as a State-approved Comprehensive Prenatal Diagnosis Center shall
						submit an application. Each application shall contain the following:
(1) An Application Coversheet that includes:
(A) The date the application was
						completed.
(B) The proposed name of the
						Center, organizational ownership, and any organizational unit and/or medical group
						affiliation.
(C) Center's physical
						location, the mailing address, and telephone and facsimile numbers.
(D) Genetic counseling services' physical
						location, the mailing address, and telephone and facsimile numbers.
(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.
(F) The mailing address, telephone and facsimile
						numbers for mailing and distribution of Result Mailers from the Department's
						Screening Information System.
(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 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.
(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).