Cal. Code Regs. Tit. 17, § 6527 - Clinician Requirements
(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.
(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.
(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.
(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.
(e) If the pregnant individual consents to
testing, the clinician shall arrange for prenatal screening directly or by
referral to another clinician by:
(1) Fully
and accurately completing all required specimen collection forms (physical or
electronic copy) provided by the Department for this purpose;
(2) Collecting or arranging for the
collection of specimens following state directions for collection
provided;
(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.
(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) 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.
(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.
(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) 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) 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.
(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.
(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.
(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.
Notes
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.
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.
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
11. Statement of Compliance pursuant to Health and Safety Code section 124977(d)(1) as to 12-20-2019 order
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
14. Amendment of subsection (c), new subsection (d) and subsection relettering filed 4-3-2024 as an emergency; operative
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