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 6543 - Requirements for Continued Approval as a State-Approved Comprehensive or Satellite Prenatal Diagnosis Center

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.
(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.
(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) An Annual Reporting Coversheet
						that includes:
(A) The name of the person
						submitting the documentation.
(B) The
						date the submission was completed.
(C)
						For the State-approved Comprehensive Prenatal Diagnosis Center site, the following
						clinical services information:
1. The name of the
						State-approved Comprehensive Prenatal Diagnosis Center.
2. The physical location where genetic counseling
						services are provided, and the telephone number and facsimile number of that
						location.
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. 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:
i. Amniocentesis procedures performed.
ii. Chorionic villus sampling procedures
						performed.
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. The full name,
						mailing address, telephone and facsimile numbers, and email address of the following
						personnel at the State-approved Comprehensive Prenatal Diagnosis Center:
i. Director.
ii. Contact Person.
iii. Back-up Contact Person.
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:
i. Laboratory name.
ii. Full name of the Laboratory
						Director.
iii. California License number
						for Laboratory Director.
iv. Physical
						location.
v. Full names for each of the
						Clinical Cytogeneticists employed.
vi.
						California License number for each of the Clinical Cytogeneticists
						employed.
(D) For
						each State-approved Satellite Prenatal Diagnosis Center, the following clinical
						services information:
1. The name and
						Department-assigned code of the State-approved Satellite Prenatal Diagnosis
						Center.
2. The physical location where
						genetic counseling services are provided, and the telephone number and facsimile
						number of that location.
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. 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:
i. Amniocentesis
						procedures performed.
ii. Chorionic
						villus sampling procedures performed.
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.)