BILL ANALYSIS Ó AB 170 Page 1 ASSEMBLY THIRD READING AB 170 (Gatto) As Amended May 28, 2015 Majority vote ------------------------------------------------------------------- |Committee |Votes |Ayes |Noes | | | | | | | | | | | |----------------+------+--------------------+----------------------| |Privacy |9-2 |Gatto, Wilk, |Baker, Chang | | | |Calderon, Chau, | | | | |Cooper, Dababneh, | | | | |Dahle, Gordon, Low | | | | | | | |----------------+------+--------------------+----------------------| |Health |17-0 |Bonta, Maienschein, | | | | |Bonilla, Burke, | | | | |Chávez, Chiu, | | | | |Gomez, Gonzalez, | | | | |Roger Hernández, | | | | |Lackey, | | | | | | | | | | | | | | |Ridley-Thomas, | | | | |Rodriguez, | | | | |Santiago, | | | | |Steinorth, | | | | |Thurmond, Waldron, | | | | |Wood | | | | | | | AB 170 Page 2 |----------------+------+--------------------+----------------------| |Appropriations |17-0 |Gomez, Bigelow, | | | | |Bonta, Calderon, | | | | |Chang, Daly, | | | | |Eggman, Gallagher, | | | | |Eduardo Garcia, | | | | |Gordon, Holden, | | | | |Jones, Quirk, | | | | |Rendon, Wagner, | | | | |Weber, Wood | | | | | | | | | | | | ------------------------------------------------------------------- SUMMARY: Requires the Department of Public Health (DPH) to provide information to the parent or guardian of a newborn child about the California Newborn Screening Program (CNSP) and obtain a signed acknowledgment form regarding the storage, retention, and use of the newborn child's blood sample for medical research, and also allows a parent or legal guardian of a minor or an individual who is at least 18 years of age to request that the blood sample be destroyed or not used for research purposes. Specifically, this bill: 1)Requires DPH to provide information about the CNSP and obtain a signed acknowledgment form from the parent or guardian of a newborn child regarding the storage, retention, and use of the newborn child's blood sample for medical research. 2)Clarifies that the fee charged by DPH for any tests shall be established and adjusted to meet the reasonable costs of the program. 3)Authorizes a parent or legal guardian of a minor, or an individual who is at least 18 years of age, to request that DPH destroy the blood sample of the minor collected as a newborn, or not use it for research purposes, or both, and requires DPH to AB 170 Page 3 comply with that request. 4)Requires DPH to provide informational materials regarding newborn child blood samples that include, but are not limited to, all of the following information: a) 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 the CNSP; b) A description of the benefits of early newborn child screening and the associated research undertaken regarding preventable heritable or congenital disorders; c) A description of the California Biobank Program, specifically as it pertains to the Genetic Disease Screening Program, and the subsequent storage, retention, and use of the newborn child's blood sample for medical research; and, d) An explanation of the parent's or legal guardian's right to request that his or her minor child's blood samples be destroyed or not used for research purposes, or both, and the information necessary to make that request. e) A statement that an individual who is at least 18 years of age has the right to request that his or her blood sample be destroyed or not used for research purposes, or both, and the information necessary to make that request. 1)Requires these informational materials to be confined to a single page and presented in a document separate from the AB 170 Page 4 standard informational acceptance form, as specified. 2)Requires DPH to prepare a standard informational acceptance form that includes all of the following: a) A brief, plain language explanation of the newborn child screening test and retention of newborn child blood samples collected pursuant to the CNSP. b) An explanation of the parent's or legal guardian's right to request that his or her minor child's blood sample be destroyed or not used for research purposes, or both, and the information necessary to make that request; c) A space for the parent or legal guardian of the newborn child to acknowledge receipt of informational materials; and, d) A space for the parent or legal guardian of the newborn child to sign and date the form 1)Requires the standard informational acceptance form to be confined to a single page and presented in a separate document from the informational materials. 2)Requires a copy of the standard informational acceptance form to be maintained in the medical record of the mother of the newborn child. 3)Requires, in the event that there is no signed standard informational acceptance form retained in the mother's medical AB 170 Page 5 record, the newborn child to receive the genetic screening test and the newborn child blood sample to be stored and retained for medical research, as specified. 4)Requires DPH generally to provide a parent or legal guardian with the informational materials and standard informational acceptance form regarding the retention of newborn child blood samples. 5) Requires the informational materials and standard informational acceptance form to be distributed as follows: a) A birth attendant who provides perinatal care to a pregnant woman, prior to the estimated date of delivery, shall provide a copy of the informational materials and a copy of the standard informational acceptance form provided by DPH. b) If the informational material or standard informational acceptance form has not yet been provided, a perinatal licensed health facility shall provide a pregnant woman admitted for delivery with a copy of the informational materials and a copy of the standard informational acceptance form provided by DPH. c) The local registrar of births and deaths shall provide a copy of the informational material and a copy of the standard informational acceptance form provided by DPH 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 of age; and shall notify the local health officer and DPH of each of these registrations. AB 170 Page 6 1)Makes findings and declarations pertaining to legislative intent. 2)Makes other clarifying or nonsubstantive changes. FISCAL EFFECT: According to the Assembly Appropriations Committee: 1)One-time costs of $120,000 to promulgate regulations (Genetic Disease Testing Fund). 2)Annual costs of $550,000 (Genetic Disease Testing Fund) for printing, storage, and distribution of forms, and staff to provide technical support and enforce collection and submittal of forms. If an increased number of requests to destroy specimens is received, minor potential increased laboratory staff costs would be incurred. COMMENTS: Purpose of this bill. This bill is intended to ensure the informed consent of parents and protect the genetic privacy of children born in this state by requiring DPH to provide parents with informational materials and a written acknowledgment form regarding the CNSP, its use of blood samples for subsequent medical research, and the right to request that the blood sample for one's child or oneself be destroyed or not used for research purposes. This measure is author-sponsored. Analysis Prepared by: Jennie Bretschneider / P. & C.P. / (916) 319-2200 AB 170 Page 7 FN: 0000826