BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                       AB 170


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          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                |                      |
          |                |      |                    |                      |








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          |----------------+------+--------------------+----------------------|
          |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  








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            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  








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            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  








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            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.  









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          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   








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