Cal. Code Regs. tit. 17, § 6523 – Prenatal Birth Defects Screening Laboratories and Analytical Methods.

(a) Only prenatal birth defects screening laboratories certified as clinical laboratories in compliance with the federal and state regulations under Division 2, Chapter 3 (commencing with Section 1200) of the Business and Professions Code in contract with the Department may participate in the California Prenatal Screening Program.
(b) Prenatal birth defects screening laboratories that choose to participate in the California Prenatal Screening Program shall be limited to the following:
1. (1) A laboratory shall have obtained a contract from the Department under applicable laws and regulations to provide laboratory services in sufficient volume to provide prenatal screening for fetal autosomal trisomies, sex chromosome aneuploidies, fetal sex if requested, and other genetic conditions detectable by cfDNA screening as determined by the Department, or prenatal screening for neural tube defects to pregnant individuals, in a quantity specified in their contract, plus an emergency testing capacity that will be specified by contract.
2. (2) A laboratory exclusively serving a comprehensive prepaid group practice or health care service plan with 20,000 or more births in the last completed calendar year for which complete statistics are available may be approved for testing consistent with the terms of a mutually acceptable contract for services with the Department.
(c) Clinical laboratories participating in the California Prenatal Screening Program shall comply with all laboratory standards for quality assurance in accordance with the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) specified in section 1202.5 of the Business and Professions Code and shall participate in a proficiency testing program approved and/or conducted by the Department and shall maintain levels of performance acceptable to the Department.

Note: Authority cited: Sections 124977, 124980, 124996, 125000, 125055, 125070 and 131200, Health and Safety Code. Reference: Sections 124975, 124980, 124990, 125000, 125001, 125050, 125055 and 125070, Health and Safety Code.

History

1. New section filed by the Department of Health Services with the Secretary of State on 4-7-86 as an emergency; effective upon filing. Submitted to OAL for printing only pursuant to Government Code Section 11343.8 (Register 86, No. 16).

2. Amendment of section heading, section and Note filed 6-14-96 as an emergency; operative 6-14-96. Submitted to OAL for printing only pursuant to Government Code section 11343.8 (Register 96, No. 24).

3. Editorial correction of History 2 (Register 97, No. 12).

4. Repeal of subsections (b)(3) and (f) filed 3-14-97 by the Department of Health Services with the Secretary of State; operative 3-14-97. Submitted to OAL as an emergency for printing only pursuant to Health and Safety Code section 125000 (Register 97, No. 12).

5. Amendment of subsection (b)(2) filed 9-25-97; operative 9-25-97. Submitted to OAL for printing only pursuant to Health and Safety Code section 125000 (Register 97, No. 39).

6. Change without regulatory effect adding article 3 heading filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

7. Amendment of section heading, section and Note 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.

8. 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).

9. Amendment of subsections (b)(1)-(2) and (d)-(e) 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.

10. Refiling of 7-18-2022 emergency amendments, including further amendment of subsections (b)(1) and (d)-(e), on 9-9-2022 as an emergency; operative 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.

11. Amendment of section 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.

12. 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).