SB 625: Newborn screening: genetic diseases: blood samples collected.

Existing law requires the State Department of Public Health to establish a genetic disease unit to, among other responsibilities, promote a statewide program of information, testing, and counseling services related to genetic diseases, and administer that information, testing, and counseling to each child born in the state, unless the childs parent or guardian objects to a test on the grounds of religious beliefs or practices.

This bill would require the department to provide information about the testing program and to permit the parent or legal guardian to withhold consent to the storage, retention, and opt out of the retention or use of the newborn childs blood sample for medical research. The bill would prohibit any residual newborn screening specimen from being released to any person or entity for law enforcement purposes or to establish a database for forensic identification. The bill would authorize a parent or guardian of a minor child, and the newborn child, once they are at least 18 years of age, to request that the department destroy the blood sample, not use it for research purposes, or both, and the residual screening specimen or retain the specimen, but not use it for research purposes. The bill would require the department to comply with the request. The bill would require the department, if the individual makes a request to destroy the blood sample specimen or to not use it for research purposes, to acknowledge receipt of the request and notify the individual that the blood sample specimen has been destroyed, as specified.

The bill would require the department, on or before January 1, 2025, 2026, to provide prepare an informational brochure regarding the collection, storage, retention, and use of the blood sample in a separate, double-sided, single-page format, as specified. The bill would require the department, on or before January 1, 2026, to additionally prepare a separate standard informational acceptance form with a space for the parent or legal guardian of the newborn child to provide a signed and dated written acknowledgment of receipt of the informational brochure and would require the form to be maintained in the mothers medical file, as specified. The bill would also require the department, on or before January 1, 2025, 2026, to update the California Newborn Screening Test Request Form to include space for the parent or guardian to acknowledge receipt of the above-described brochure and to choose whether to consent to or refuse the genetic tests because of religious objections and whether to consent to the storage or use for research of the blood sample. to choose whether to opt out of the retention or use for research of the residual screening specimen. The bill would require the form to have a space for the parent or guardian to sign and date the form to confirm their receipt of the brochure and their choices. choice. The bill would require specified persons to distribute the informational brochure, including the local registrar of births to provide a copy of the informational brochure to each person registering the birth of a newborn that occurred outside of a perinatal licensed health facility, as specified. The bill would also require the local registrar to notify the local health officer and the department of each of these registrations by the local registrar. By imposing additional duties on local registrars of births, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that, if the Commission on State Mandates determines that the bill contains costs mandated by the state, reimbursement for those costs shall be made pursuant to the statutory provisions noted above.