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 6546 - Requirements for Laboratories to be Approved to Perform Follow-Up Services

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) An Applicant
						laboratory seeking approval from the Department to perform prenatal cytogenomic
						and/or cytogenetic tests on amniotic fluid and/or chorionic villus samples from
						State-approved Comprehensive or Satellite Prenatal Diagnosis Centers for California
						Prenatal Screening Program referrals, shall submit an application to the Department
						by mail. Each application shall contain the following information:
(1) A Laboratory Director Statement shall:
(A) Affirm the Director of the Applicant
						laboratory is a physician or holds a doctorate degree, has training and experience
						as a Clinical Cytogeneticist directing a cytogenetics laboratory, and is certified
						by the American Board of Medical Genetics and Genomics or Canadian College of
						Medical Genetics in Clinical Cytogenetics.
(B) State the name, address, telephone, and
						facsimile number of the Applicant laboratory.
(C) Include the Clinical Laboratory Improvement
						Amendments (CLIA) certificate number and the California Laboratory License number of
						the Applicant laboratory.
(D) Include
						the Laboratory Director's signature, full name, and date of signing.
(E) Include the California License Number of the
						Laboratory Director, licensed in California as a Clinical Cytogeneticist.
(F) Affirm the Applicant laboratory has the
						capacity to meet the annual test volume requirements in the Prenatal Diagnosis
						Center Standards and Definitions 2022, incorporated by reference.
(G) Affirm the Applicant laboratory has
						participated in, and successfully completed, the State of California-provided or
						approved laboratory inspection proficiency testing and/quality control
						program.
(H) Affirm the Applicant
						laboratory has resources for the determination of alpha fetoprotein and
						acetylcholinesterase concentrations in amniotic fluid for diagnosis of neural tube
						defects. If resources are to be provided by another facility, an Alpha
						Fetoprotein/Acetylcholinesterase Concentration Determination Statement must be
						attached and include the following information:
1.
						Name of the Applicant laboratory.
2.
						Affirm Applicant laboratory has access to resources for the determination of alpha
						fetoprotein and acetylcholinesterase concentrations in amniotic fluid for diagnosis
						of neural tube defects.
3. Name of the
						laboratory providing these resources.
4.
						CLIA certificate number of the laboratory providing these resources.
5. California Laboratory License number of the
						laboratory providing these resources.
6.
						Address, telephone, and facsimile number of the laboratory providing these
						resources.
7. Name, signature, and date
						of signing by the Laboratory Director of the laboratory providing these
						resources.
8. California License number
						of the Laboratory Director of the laboratory providing these
						resources.
(I) For chorionic
						villus sampling laboratory Applicants, affirm the Applicant laboratory has the
						capacity for cultures to include tissue culture of villus core.