Bill Text: CA SB625 | 2023-2024 | Regular Session | Amended

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Bill Title: Newborn screening: genetic diseases: blood samples collected.

Spectrum: Partisan Bill (Republican 1-0)

Status: (Failed) 2024-02-01 - Returned to Secretary of Senate pursuant to Joint Rule 56. [SB625 Detail]

Download: California-2023-SB625-Amended.html

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Amended  IN  Senate  January 11, 2024

Amended  IN  Senate  January 03, 2024

Amended  IN  Senate  April 24, 2023

CALIFORNIA LEGISLATURE— 2023–2024 REGULAR SESSION

Senate Bill

No. 625

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Introduced by Senator Nguyen

February 16, 2023

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An act to amend Section 125000 of, and to add Sections 125003, 125004, and 125005 125005, and 125006 to, the Health and Safety Code, relating to newborn screening.

LEGISLATIVE COUNSEL'S DIGEST

SB 625, as amended, Nguyen. 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 child’s 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 child’s 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 mother’s 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 bill would additionally require the health care professional who is completing the California Newborn Screening Test Request Form, after entering information on the form and prior to a blood sample being drawn from the infant, to provide the form to the parent or legal guardian of the infant and give them a reasonable amount of time to verify the information on the form, acknowledge receipt of the brochure, indicate their choices about the use of the infant’s blood, and to sign and date the form.

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.

Digest Key

Vote: MAJORITY   Appropriation: NO   Fiscal Committee: YES   Local Program: YES  

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Bill Text

The people of the State of California do enact as follows:

SECTION 1.

 Section 125000 of the Health and Safety Code is amended to read:

125000.

 (a) It is the policy of the State of California to make every effort to detect, as early as possible, phenylketonuria and other preventable heritable or congenital disorders leading to intellectual disability or physical defects. disabilities.

The department shall establish a genetic disease unit, unit that shall coordinate all programs of the department in the area of genetic disease. The unit shall promote a statewide program of information, testing, research, and counseling services and shall have the responsibility of designating tests and regulations to be used in executing this program.

The information, tests, and counseling for children shall be in accordance with accepted medical practices and shall be administered to each child born in California once the department has established appropriate regulations and testing methods. The information, tests, and counseling for pregnant women shall be in accordance with accepted medical practices and shall be offered to each pregnant woman in California once the department has established appropriate regulations and testing methods. These regulations shall follow the standards and principles specified in Section 124980. The department may provide laboratory testing facilities or contract with any laboratory that it deems qualified to conduct tests required under this section. However, notwithstanding former Section 125005, provision of laboratory testing facilities by the department shall be contingent upon the provision of funding therefor by specific appropriation to the Genetic Disease Testing Fund enacted by the Legislature. If moneys appropriated for purposes of this section are not authorized for expenditure to provide laboratory facilities, the department may nevertheless contract to provide laboratory testing services pursuant to this section and shall perform laboratory services, including, but not limited to, quality control, confirmatory, and emergency testing, necessary to ensure the objectives of this program.

(b) The department shall charge a fee for any tests performed pursuant to this section. The amount of the fee shall be established and periodically adjusted by the director in order to meet the costs of this section.

(c) The department shall inform all hospitals or physicians and surgeons, or both, of required regulations and tests and may alter or withdraw any of these requirements whenever sound medical practice so indicates. To the extent practicable, the department shall provide notice to hospitals and other payers in advance of an increase in the fees charged for the program.

(d) This section shall not apply if a parent or guardian of the newborn child objects to a test on the ground that the test conflicts with their religious beliefs or practices. the religious beliefs or practices of the parent or guardian.

(e) The genetic disease unit is authorized to make grants or contracts or payments to vendors approved by the department for all of the following:

(1) Testing and counseling services.

(2) Demonstration projects to determine the desirability and feasibility of additional tests or new genetic services. services, including research using residual screening specimens.

(3) To initiate the development of genetic services in areas of need.

(4) To purchase or provide genetic services from any sums as are appropriated for this purpose.

(f) The genetic disease unit shall evaluate and prepare recommendations on the implementation of tests for the detection of hereditary and congenital diseases, including, but not limited to, biotinidase deficiency and cystic fibrosis. The genetic disease unit shall also evaluate and prepare recommendations on the availability and effectiveness of preventative followup interventions, including the use of specialized medically necessary dietary products.

It is the intent of the Legislature that funds for the support of the evaluations and recommendations required pursuant to this subdivision, and for the activities authorized pursuant to subdivision (e), shall be provided in the annual Budget Act appropriation from the Genetic Disease Testing Fund.

(g) Health care providers that contract with a prepaid group practice health care service plan that annually has at least 20,000 births among its membership, may provide, without contracting with the department, any or all of the testing and counseling services required to be provided under this section or the regulations adopted pursuant thereto, if the services meet the quality standards and adhere to the regulations established by the department and the plan pays that portion of a fee established under this section that is directly attributable to the department’s cost of administering the testing or counseling service and to any required testing or counseling services provided by the state for plan members. The payment by the plan, as provided in this subdivision, shall be deemed to fulfill any obligation the provider or the provider’s patient may have to the department to pay a fee in connection with the testing or counseling service.

(h) The department may appoint experts in the area of genetic screening, including, but not limited to, cytogenetics, molecular biology, prenatal, specimen collection, and ultrasound to provide expert advice and opinion on the interpretation and enforcement of regulations adopted pursuant to this section. These experts shall be designated agents of the state with respect to their assignments. These experts shall receive no salary, but shall be reimbursed for expenses associated with the purposes of this section. All expenses of the experts for the purposes of this section shall be paid from the Genetic Disease Testing Fund.

(i)The department shall permit the parent or legal guardian to withhold consent to allow for the storage and confidential use of the blood sample of the minor for research purposes by the department or the department’s approved researchers. The parent or legal guardian shall be offered the opportunity to withhold their consent in writing before or at the time the blood sample of the minor is taken.

(i) The department shall permit the parent or legal guardian to opt out of the retention and confidential use of their newborn’s residual screening specimen for research purposes by the department or the department’s approved researchers in writing at the time the newborn’s blood sample is taken.

(j) A residual newborn screening specimen shall not be released to any person or entity for law enforcement purposes or to establish a database for forensic identification.

(k)(1)A parent or legal guardian of a minor may request the department to destroy the blood sample of the minor collected as a newborn, or not use it for research purposes, or both, and the department shall comply with that request.

(k) (1) A minor’s parent or legal guardian may request the department to do either of the following:

(A) Destroy the minor’s residual screening specimen.

(B) Retain the residual screening specimen, but not use it for research purposes.

(2) (A) The department shall comply with a request made pursuant to paragraph (1).

(B) If the request is for the specimen to be destroyed, the department shall destroy the specimen within 30 days of the request.

(2)

(3) (A) If the parent or legal guardian makes the request by email, the department shall send an email acknowledging that the department received the request within 30 days of receiving the request.

(B) If the parent or legal guardian makes the request in writing, the department shall send a written acknowledgment that the department received the request within 30 days of receiving the request.

(3)

(4) If the parent or legal guardian requests the department to destroy the blood sample of the minor, minor’s residual screening specimen, the department shall notify the parent or legal guardian in the same manner as described in paragraph (2) that the minor’s blood sample (3) that the specimen was destroyed destroyed. This notification shall be provided as soon as possible, but no later than 30 days, after destroying the sample. the destruction of the specimen.

(l)(1)An individual who is at least 18 years of age may request the department to destroy, not use for research purposes, or both, their blood sample that was collected, and the department shall do so.

(l) (1) An individual who is at least 18 years of age may request the department to do either of the following:

(A) Destroy the individual’s residual screening specimen.

(B) Retain the residual screening specimen, but not use it for research purposes.

(2) (A) The department shall comply with a request made pursuant to paragraph (1).

(B) If the request is for the specimen to be destroyed, the department shall destroy the specimen within 30 days of the request.

(2)

(3) (A) If the individual makes the request by email, the department shall send an email acknowledging that the department received the request within 30 days of receiving the request.

(B) If the individual makes the request in writing, the department shall send a written acknowledgment that the department received the request within 30 days of receiving the request.

(3)

(4) If the individual requests the department to destroy their blood sample, residual screening specimen, the department shall notify the individual in the same manner as described in paragraph (2) that their blood sample (3) that the specimen was destroyed destroyed. This notification shall be provided as soon as possible, but no later than 30 days, after destroying the sample. the destruction of the specimen.

SEC. 2.

 Section 125003 is added to the Health and Safety Code, to read:

125003.

 (a) The department shall, on or before January 1, 2025, 2026, prepare and provide an informational brochure regarding newborn child blood samples collected pursuant to this article that includes, but is not limited to, all of the following:

(1)A brief, plain-language explanation of, and the purpose for, the newborn child screening test and the storage, retention, and use of newborn child blood samples collected pursuant to this article, including that the samples may be shared with third parties for research purposes.

(1) A brief, plain-language explanation of the purpose for, and the importance of, the newborn child screening test and the retention and potential uses of residual screening specimens collected pursuant to this article.

(2) A description of the benefits of both early newborn child screening and the associated research undertaken regarding preventable heritable or congenital disorders.

(3) A description of the California Biobank Program, specifically as it pertains to the Genetic Disease Screening Program, and subsequent storage, retention, and use of the newborn child’s blood sample retention and potential use of the newborn’s residual screening specimen for medical research.

(4) The parent or legal guardian’s right to refuse the test based on their religious beliefs.

(5) The parent or legal guardian’s right to withhold consent for their minor child’s blood sample to be stored and opt out of their newborn’s residual screening specimen being retained or used for research purposes.

(6)The parent or legal guardian’s right to request that their minor child’s blood sample be destroyed, not used for research purposes, or both, if the parent or legal guardian has not initially withheld consent to the sample being stored and used for research purposes at the time the sample is taken, and the information necessary to make that request.

(6) The parent or legal guardian’s right to request that their minor child’s residual screening specimen be destroyed or retained but not used for research purposes if the parent or legal guardian did not opt out of the specimen being retained or used for research purposes at the time the specimen was taken, and the information necessary to make that request.

(7) The right of an individual who is at least 18 years of age to request that their blood sample be destroyed, not used for research purposes, or both, residual screening specimen be destroyed or retained but not used for research purposes and the information necessary to make that request.

(b) The informational brochure shall be confined to a single, double-sided page and presented in a separate document from the form described in Section 125004.

SEC. 3.Section 125004 is added to the Health and Safety Code, to read:

125004.

(a)(1)The department shall, on or before January 1, 2025, update the California Newborn Screening Test Request Form (TRF) so that it includes a list with appropriate checkboxes of all of the following:

(A)An acknowledgment of receipt of the informational brochure described in Section 125003.

(B)The option to consent or refuse the initial screening test because of religious objections to the test.

(C)The option to consent or refuse the retention and storage of the newborn blood sample.

(D)The option to consent or refuse the use of the newborn blood sample for research purposes.

(2)Immediately following the list in paragraph (1), the form shall have space for the parent or legal guardian of the newborn child to provide a dated signature acknowledging their receipt of the brochure in subparagraph (A) and their choices in subparagraphs (B) through (D), inclusive.

(b)(1)(A)If the parent or legal guardian refuses the retention and storage of the sample as described in subparagraph (C) of paragraph (1) of subdivision (a) and the sample tests negative for all hereditary conditions, the department shall destroy the sample within 30 days of completing the genetic screening tests authorized by this article.

(B)If the parent or legal guardian refuses the retention and storage of the sample as described in subparagraph (C) of paragraph (1) of subdivision (a) and the sample tests positive for one or more hereditary conditions, the samples shall be retained only long enough to complete confirmation tests. The department shall destroy the sample within 30 days of completing the confirmation tests.

(2)If the parent or legal guardian refuses the use of the newborn blood sample for research purposes as described in subparagraph (D) of paragraph (1) of subdivision (a), the department shall segregate the sample from those samples that are authorized for use in research.

(c)If emergency circumstances make it impossible to obtain the signature required by subdivision (a), a note shall be placed in the medical record of the mother documenting the emergency or reason why the signature could not be obtained. The newborn child shall be administered the genetic screening tests, but the newborn child’s blood sample shall not be stored or retained for medical research pursuant to Section 125000.

(1)If the signature is not obtained and the sample tests negative for all hereditary conditions, the department shall destroy the sample within 30 days of completing the genetic screening tests authorized by this article.

(2)If the signature is not obtained and the sample tests positive for one or more hereditary conditions, the sample shall be retained only long enough to complete confirmation tests. The department shall destroy the sample within 30 days of completing the confirmation tests.

SEC. 4.Section 125005 is added to the Health and Safety Code, to read:

125005.

(a)The informational brochure described in Section 125003 shall be distributed as follows:

(1)A birth attendant engaged in providing perinatal care shall provide a pregnant woman, at least four weeks prior to the estimated date of delivery, with a copy of the informational brochure.

(2)If the informational brochure has not been provided pursuant to paragraph (1), a perinatal licensed health facility shall provide each pregnant woman admitted for delivery with a copy of the informational brochure provided by the department.

(3)The local registrar of births and deaths shall provide a copy of the informational brochure provided by the department to each person registering the birth of a newborn that occurred outside of a perinatal licensed health facility when the newborn was not admitted to a perinatal licensed health facility within the first 30 days after birth. The local registrar of births and deaths shall notify the local health officer and the department of each of these registrations.

(b)(1)A health care professional that has entered information about an infant on the updated California Newborn Screening Test Request Form described in Section 125004 shall, after entering information on the form and prior to blood samples being drawn from the infant, provide the form to the parent or legal guardian of the infant.

(2)The parent or legal guardian shall be given a reasonable amount of time to verify the information on the form, acknowledge receipt of the brochure, indicate their choices about the use of the infant’s blood, and to sign and date the form as described in Section 125004.

(3)After the parent or legal guardian has signed and dated the form, a health care professional may draw blood from the infant.

(c)For the purposes of this section, the following terms shall have the following meanings:

(1)“Birth attendant” means a person licensed or certified by the state to provide maternity care and to deliver pregnant women or to practice medicine.

(2)“Perinatal licensed health facility” means a health facility licensed by the state and approved to provide perinatal, delivery, newborn intensive care, newborn nursery, or pediatric services.

SEC. 3.

 Section 125004 is added to the Health and Safety Code, to read:

125004.

 (a) The department shall, on or before January 1, 2026, prepare a separate standard informational acceptance form that includes all of the following:

(1) A brief, plain-language explanation of, and the purpose for, the newborn child screening test and the retention and potential uses of residual screening specimens collected pursuant to this article.

(2) The parent or legal guardian’s right to refuse the test based on the religious beliefs of the parent or legal guardian.

(3) An explanation of the parent’s or legal guardian’s right to opt out of the retention and use of the residual screening specimen for research purposes at the time the specimen is taken.

(4) An explanation of the parent’s or legal guardian’s right to request that their minor child’s residual screening specimen be destroyed or retained but not used for research purposes if the parent or legal guardian did not opt out of the specimen being retained and used for research purposes at the time the specimen was taken, and the information necessary to make that request.

(5) 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 regarding the retention and use of the newborn child’s residual screening specimen for medical research.

(b) The standard form shall be confined to a single page and presented in a separate document from the informational brochure required in Section 125003.

(c) A copy of the signed standard form shall be maintained by the prenatal care provider or the perinatal licensed health facility in the medical record of the mother of the newborn child.

(d) As used in this article, “informational acceptance form” or “standard form” means the form described in subdivision (a).

SEC. 4.

 Section 125005 is added to the Health and Safety Code, to read:

125005.

 (a) (1) The department shall, on or before January 1, 2026, update the California Newborn Screening Test Request Form (TRF) so that it includes a list with appropriate spaces for all of the following:

(A) The option to refuse the retention of the newborn’s residual screening specimen.

(B) The option to allow the retention, but refuse the use of the newborn’s residual screening specimen for research purposes.

(2) Immediately following the list in paragraph (1), the form shall have space for the parent or legal guardian of the newborn child to provide a dated signature confirming their choice in paragraph (1).

(b) (1) (A) If the parent or legal guardian refuses the retention of the residual screening specimen as described in subparagraph (A) of paragraph (1) of subdivision (a) and the specimen tests negative for all hereditary conditions, the department shall destroy the specimen within 30 days of completing the genetic screening tests authorized by this article.

(B) If the parent or legal guardian refuses the retention of the specimen as described in subparagraph (A) of paragraph (1) of subdivision (a) and the specimen tests positive for one or more hereditary conditions, the specimen shall be retained only long enough to complete confirmation tests. The department shall destroy the specimen within 30 days of completing the confirmation tests.

(2) If the parent or legal guardian refuses the use of the residual screening specimen for research purposes as described in subparagraph (B) of paragraph (1) of subdivision (a), the department shall segregate the specimen from those specimens that are authorized for use in research.

SEC. 5.

 Section 125006 is added to the Health and Safety Code, to read:

125006.

 (a) The informational brochure described in Section 125003 and the standard informational acceptance form described in Section 125004 shall be distributed as follows:

(1) The primary prenatal provider engaged in providing prenatal care shall provide a pregnant woman, at least four weeks prior to the estimated date of delivery, with a copy of the informational brochure and a copy of the standard informational acceptance form provided by the department.

(2) If a perinatal licensed health facility knows the pregnant woman did not receive prenatal care, or that the informational brochure or standard informational acceptance form has not been provided pursuant to paragraph (1), a perinatal licensed health facility shall provide each pregnant woman admitted for delivery with a copy of the informational brochure and a copy of the standard informational acceptance form provided by the department.

(3) The local registrar of births and deaths shall provide a copy of the informational brochure and a copy of the standard informational acceptance form provided by the department to each person registering the birth of a newborn that occurred outside of a perinatal licensed health facility when the newborn was not admitted to a perinatal licensed health facility within the first 30 days after birth. The local registrar of births and deaths shall notify the local health officer and the department of each of these registrations.

(b) For the purposes of this section, the following terms have the following meanings:

(1) “Prenatal care provider” means a person licensed or certified by the state to provide maternity care and to deliver pregnant women or to practice medicine.

(2) “Perinatal licensed health facility” means a health facility licensed by the state and approved to provide perinatal, delivery, newborn intensive care, newborn nursery, or pediatric services.

SEC. 5.SEC. 6.

 If the Commission on State Mandates determines that this act contains costs mandated by the state, reimbursement to local agencies and school districts for those costs shall be made pursuant to Part 7 (commencing with Section 17500) of Division 4 of Title 2 of the Government Code.