1. (a) Clinicians shall provide or cause to be provided to all pregnant individuals in their care before 21 weeks 0 days (147 days) of gestation, or before 19 weeks 0 days (133 days) from conception, as estimated by medical history or clinical testing, information regarding the California Prenatal Screening Program. This information shall be in a format provided by the Department and shall be given at the first prenatal visit and discussed with each pregnant individual.
2. (b) The provisions of subsection (a) shall not apply if the pregnant individual has completed more than 21 weeks 0 days (147 days) of gestation or 19 weeks 0 days (133 days) post conception, as estimated by medical history or clinical testing, and this fact is entered in the medical record.
3. (c) Clinicians shall cause to be provided to all pregnant individuals who, after being provided with the information pursuant to subsection (a), voluntarily request to participate in the California Prenatal Screening Program and receive prenatal screening for fetal autosomal trisomies, sex chromosome aneuploidies, and other genetic conditions as determined by the Department, and/or prenatal screening for neural tube defects, the opportunity, to complete consent documentation in a format provided by the Department, the circumstances of which are to be documented in the medical record. Maternal plasma and serum specimens must be accompanied by the pregnant individual's completed Department-designated consent form to be analyzed for screening.
4. (d) Clinicians must offer patients the opportunity to accept or reject screening for fetal sex detection and must record the patient's choice on the test requisition form.

5. (e) If the pregnant individual consents to testing, the clinician shall arrange for prenatal screening directly or by referral to another clinician by:

   1. (1) Fully and accurately completing all required specimen collection forms (physical or electronic copy) provided by the Department for this purpose;
   2. (2) Collecting or arranging for the collection of specimens following state directions for collection provided;
   3. (3) As soon as possible, but within 24 hours of collection, place or cause to be placed all specimens in the channel of transmittal to the designated prenatal birth defects screening laboratory.

6. (f) Blood collection forms and testing kits supplied by the Department or approved contractors shall not be copied, printed, reproduced, acquired, purchased, substituted, or distributed other than as specified for use by the California Prenatal Screening Program administered by the Department.

   1. (1) Prenatal licensed health facilities and blood draw stations shall obtain from the Department a sufficient supply of specimen collection tubes for prenatal screening for neural tube defects.
7. (g) When notified that a blood specimen is inadequate for testing, the clinician shall make a reasonable effort to have an adequate specimen obtained as soon as possible but not more than five (5) days after such notification.

8. (h) For each individual in their care who participates in the California Prenatal Screening Program and who has a screen positive test result, as defined by the California Prenatal Screening Program, the clinician shall:

   1. (1) Inform the individual that authorized follow-up services are available to that individual at State-approved Comprehensive and Satellite Prenatal Diagnosis Centers, and that the program participation fee(s) covers the authorized services.
   2. (2) Report on the form provided by the Department for this purpose, within 60 calendar days of the end of the pregnancy, the outcome of pregnancy and status of each fetus, or infant resulting therefrom.
9. (i) The test results shall be confidential so that such information shall only be released with the knowledge and specific written consent of the individual tested. Persons authorized by the Department to conduct and monitor screening and/or to provide and monitor follow-up services shall be provided information without necessity of specific written consent.
10. (j) Recognizing the strict gestational and time limits wherein prenatal detection of birth defects of the fetus is feasible, clinicians shall make every reasonable effort to schedule screening and differential diagnostic tests and procedures appropriately with respect to the gestational dates of the pregnant individual.
11. (k) Willful or repeated failure to comply with these regulations shall be referred by any person having knowledge of noncompliance to the appropriate licensing authority.

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, 125060, 125065 and 125070, Health 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. New subsection (j) filed by the Department of Health Services with the Secretary of State on 6-16-88 as an emergency; effective 7-1-88. Submitted to OAL for printing only pursuant to Government Code Section 11343.8 (Register 88, No. 27).

3. Certificate of Compliance as to 6-16-88 order transmitted to OAL 10-19-88 and filed 11-18-88 (Register 88, No. 48).

4. Amendment filed 8-7-91 by the Department of Health Services with the Secretary of State, operative 8-7-91. Submitted to OAL as an emergency for printing only pursuant to Health and Safety Code section 309 (Register 91, No. 50).

5. Amendment of 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).

6. Editorial correction of History 5 (Register 97, No. 12).

7. Amendment of subsections (a), (c), (d)(1) and (d)(2), repealer of subsection (e), subsection relettering, and amendment of newly designated subsection (g)(1) 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).

8. Editorial correction of subsection (g) and Note (Register 97, No. 41).

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

10. Amendment of 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.

11. 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).

12. Amendment 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.

13. Amendment of section, including further amendment of subsection (c), refiled 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.

14. Amendment of subsection (c), new subsection (d) and subsection relettering 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.

15. 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).