BILL ANALYSIS                                                                                                                                                                                                    



                                                                       



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          |SENATE RULES COMMITTEE            |                   SB 962|
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                              UNFINISHED BUSINESS


          Bill No:  SB 962
          Author:   Migden (D)
          Amended:  9/7/07
          Vote:     21

           
           SENATE HEALTH COMMITTEE  :  6-3, 4/18/07
          AYES:  Kuehl, Alquist, Cedillo, Ridley-Thomas, Steinberg,  
            Yee
          NOES:  Aanestad, Cox, Wyland
          NO VOTE RECORDED:  Maldonado, Negrete McLeod

           SENATE JUDICIARY COMMITTEE  :  3-2, 4/24/07
          AYES:  Corbett, Kuehl, Steinberg
          NOES:  Harman, Ackerman

           SENATE APPROPRIATIONS COMMITTEE  :  10-6, 5/31/07
          AYES:  Torlakson, Cedillo, Corbett, Florez, Kuehl, Oropeza,  
            Ridley-Thomas, Simitian, Steinberg, Yee
          NOES:  Cox, Aanestad, Ashburn, Dutton, Runner, Wyland
          NO VOTE RECORDED:  Battin

           SENATE FLOOR  :  25-14, 6/6/07
          AYES:  Alquist, Calderon, Cedillo, Corbett, Ducheny,  
            Florez, Kehoe, Kuehl, Lowenthal, Machado, Margett,  
            Migden, Negrete McLeod, Oropeza, Padilla, Perata,  
            Ridley-Thomas, Romero, Scott, Simitian, Steinberg,  
            Torlakson, Vincent, Wiggins, Yee
          NOES:  Aanestad, Ackerman, Ashburn, Cogdill, Correa, Cox,  
            Denham, Dutton, Harman, Hollingsworth, Maldonado,  
            McClintock, Runner, Wyland
          NO VOTE RECORDED:  Battin

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           ASSEMBLY FLOOR  :  61-13, 9/10/07 - See last page for vote


           SUBJECT  :    Umbilical cord blood:  research

           SOURCE  :     American Association of University Women
                      Planned Parenthood Affiliates of California


           DIGEST  :    This bill requires the Department of Public  
          Health, as part of the Hereditary Disorders Act, to provide  
          umbilical cord blood samples to the Birth Defect Monitoring  
          Program, for storage and research. Makes legislative  
          findings and declarations, as specified

           Assembly Amendments  removed the Umbilical Cord Blood  
          Biomedical Resources Birth Defects Monitoring Program Fund  
          and related provisions, and re-established the Birth  
          Defects Monitoring Program Fund that is in current law.   
          Amendments also clarified that cord blood research is a  
          donation option for pregnant women, required researchers to  
          pay the state for use of cord blood and other blood samples  
          and gave the state options to address the initial start-up  
          cost of the research program.

           ANALYSIS  :    

          Existing law:

          1.Governs the licensure of blood banks, including licensure  
            or accreditation for purposes of umbilical cord blood  
            banking, as specified. 

          2.Specifies that implementation of all provisions relating  
            to umbilical cord blood banking are implemented when the  
            Director of the Department of Finance has determined that  
            sufficient private donations have been collected and  
            deposited into the Umbilical Cord Blood Education  
            Account. 

          This bill requires the Department of Public Health (DPH),  
          as part of the Hereditary Disorders Act, to provide  
          umbilical cord blood samples to the Birth Defect Monitoring  
          Program (BDMP), for storage and research.

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          This bill: 

          1. Adds to the information that the Department of Health  
             Services (DHS) is required to develop and to inform  
             pregnant women about the possible uses of umbilical cord  
             blood, and specifies that these options must be outlined  
             in the DPH information:  a) discard the umbilical cord  
             blood, b) donate the umbilical cord blood to a public  
             umbilical cord blood bank, or, c) store the umbilical  
             cord blood in a family umbilical cord blood bank for use  
             by immediate and extended family members.  Expands the  
             languages in which DHS is required to provide this  
             information to women, and requires DHS to update this  
             information as needed. 

          2. Revises current law to authorize a primary prenatal care  
             provider to provide a woman on her first prenatal care  
             visit, information regarding the options described in  
             #1) above to her for the disposition of her umbilical  
             cord blood at the end of her pregnancy. 

          3. Requires DPH to provide any umbilical cord blood samples  
             it receives to BDMP for storage and research. 

          4. Requires that all information collected pursuant to BDMP  
             be confidential and used solely for the purposes of  
             BDMP.  Prohibits the disclosure of confidential  
             information beyond BDMP.  Requires that access to  
             confidential information be limited to authorized  
             persons who agree, in writing, to maintain  
             confidentiality. Provides penalties, as specified, for  
             any unauthorized disclosure of confidential information.  


          5. Requires that disclosure of confidential information is  
             permitted only with written agreement that the  
             information be kept confidential and not further  
             disclosed. Requires that DPH maintain an accurate record  
             of all persons who receive confidential information, and  
             to whom there has been the disclosure of confidential  
             information. 

          6. Requires DPH to establish fees to cover administrative  

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             costs to BDMP, to be collected from researchers and  
             health care providers approved by DPH who seek to use  
             umbilical cord blood samples for research. 

          7. Requires fees collected as provided in #6) above be  
             deposited in the BDMP Fund, which is also created by  
             this bill. Requires that moneys in this special program  
             fund be used for costs related to this bill, including  
             data management, linkage and entry, and umbilical cord  
             blood storage, retrieval, processing, inventory, and  
             shipping. 

          8. Requires DPH to adopt rules and regulations pursuant to  
             existing requirements in the BDMP statutes. 

          9. Requires DPH, health care providers, and local health  
             departments to maintain the confidentiality of patient  
             information in accordance with existing law and in the  
             same manner as other medical record information with  
             patient identification that they possess and to use the  
             information only for the following research purposes: 

                A.      To identify risk factors for children's and  
                  women's disease. 
                B.      To develop and evaluate screening tests. 
                C.      To develop and evaluate prevention  
                  strategies; and. 
                D.      To develop and evaluate treatments. 

          1. Requires that the State Committee for the Protection of  
             Human Subjects, prior to the release of any personal  
             information associated with BDMP samples from DPH for  
             research purposes, to: 

                A.      Determine whether the requested personal  
                  information is needed to conduct the research. 

                B.      Permit access to personal information only if  
                  it is needed for the research activity. 

                C.      Permit access only to the minimum necessary  
                  personal information needed for the research  
                  activity. 


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                D.      Require the assignment of unique subject  
                  codes that are not derived from personal  
                  information in lieu of social security numbers if  
                  the research can still be conducted without social  
                  security numbers. 

                E.      If feasible, and if cost, time, and technical  
                  expertise permit, require the agency to conduct a  
                  portion of the data processing for the researcher  
                  to minimize the release of personal information. 

          1. Authorizes DPH to bill an investigator for the costs  
             associated with DPH's process of protecting personal  
             information. 

          2. States that nothing in this bill prohibits DPH from  
             using its existing authority to enter into written  
             agreements to enable other institutional review boards  
             to approve research activities, projects or classes of  
             projects for DPH, provided the data security  
             requirements set forth in this bill are satisfied. 

          3. Conditions enactment of this bill on AB 34 (Portantino)  
             and becomes operative on or before January 1, 2008.

           Background

           In December 2005, the federal government enacted H.R. 2520,  
          the Stem Cell Therapeutic and Research Act of 2005, which  
          establishes a national umbilical cord blood program and  
          provides federal funding to expand and administer cord  
          blood transplants and research.  Among the many provisions  
          in that measure is a requirement that the Secretary of  
          Health and Human Services, through a public process,  
          examine the issues of informed consent, including the  
          appropriate timing of such consent, and the information  
          provided a donor regarding medically appropriate cord blood  
          donation options.  The National Institute of Medicine (IOM)  
          recommends that women be provided with balanced and clear  
          information in order to actively and knowledgeably  
          participate in the choice of whether or how to donate cord  
          blood, with informed consent procedures.  The IOM also  
          recommends that appropriate measures should be taken to  
          ensure the security, safety, and confidentiality of medical  

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          records, transplantable products, and patients.

          According to the Cord Blood Donor Foundation, "cord blood"  
          (also known as "placental blood") is the blood that remains  
          in the umbilical cord and placenta following birth and  
          after the cord is cut.  Newborn cord blood is recognized as  
          a rich and powerful source of stem cells, which can be  
          stored to retain their unique biological properties and  
          before exposure to bacterial, viral, or other environmental  
          factors.  Stem cells recovered from umbilical cords can be  
          used to treat as many as 70 blood diseases, including  
          leukemia, myeloma and lymphoma; immunodeficiencies; and  
          genetic diseases, including sickle cell anemia,  
          thalassemia, inherited marrow failure disorders; and  
          inherited disorders or errors of metabolisms.

           Comments
           
          This bill was significantly amended in the Assembly Rules  
          Committee, the amendments incorporated key programmatic  
          provisions of SB 164 (Migden).  SB 164 requires DPH to  
          establish the Birth Defects Monitoring and Biomedical  
          Resources Program, for the purposes of creating an  
          umbilical cord blood banking system that, along with  
          prenatal genetic samples already collected by the BDMP,  
          would provide one of the most comprehensive and genetically  
          diverse databases of this nature for research and  
          transplant resources available anywhere in the country.  
          According to the author's office, the research provisions  
          of SB 164 establish a database for research which will be a  
          significant contribution to making available important  
          material to the scientific community in search of the  
          causes of genetic diseases and develop targeted treatment  
          solutions and prevention strategies 

           Prior Legislation
           
           SB 1555 (Speier), Chapter 484, Statutes of 2006  .   Created  
          the Maternal and Child Health Advancement Act, which  
          provided, among other things, that in order to provide  
          umbilical cord blood banking storage services, a blood bank  
          shall be licensed to do so under current blood bank  
          licensing law.  In addition, SB 1555, provided that a  
          primary prenatal care provider of a pregnant woman may,  

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          during the first prenatal visit, provide a pregnant woman  
          with information developed by DHS regarding her options  
          with respect to cord blood banking at the same time the  
          provider provides required information regarding the use  
          and availability of prenatal screening for birth defects of  
          the fetus.

           Related Legislation

          AB 34 (Portantino) - 2007-08 Session  .  Requires DPH to  
          establish, by July 1, 2009, the Umbilical Cord Blood  
          Collection Program for the purpose of collecting and  
          storing umbilical cord blood for public use.  The bill also  
          required DPH to contract with up to five blood banks that  
          are licensed or accredited to provide umbilical cord blood  
          banking storage services to collect, and make available to  
          doctors and their patients, umbilical cord blood. 

           FISCAL EFFECT  :    Appropriation:  No   Fiscal Com.:  Yes    
          Local:  Yes

          Major annual fee-supported special fund costs of $12  
          million to collect, screen, and store 12,000 cord blood  
          samples.  This assumes two percent of families delivering  
          babies each year will request cord blood extraction  
          pursuant to this bill at a cost of $1,000 per unit.  Actual  
          per unit collection costs range from below $1,000 to $2,000  
          depending on the volume of samples being processed. 

           SUPPORT  :   (Verified  9/10/07)

          American Association of University Women (co-source)
          Planned Parenthood Affiliates of California (co-source)
          Asian American Donor Program
          California Catholic Conference
          Cord Blood Donor Foundation
          Cord Blood Registry
          Maternal, Child and Adolescent Director (MCAH Action, CA)
          National Marrow Donor Program
          Sickle Cell Disease Association of America, Inc.

           ASSEMBLY FLOOR  : 
          AYES:  Aghazarian, Arambula, Bass, Beall, Berg, Berryhill,  
            Blakeslee, Brownley, Caballero, Charles Calderon, Carter,  

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            Cook, Coto, Davis, De La Torre, De Leon, DeSaulnier,  
            DeVore, Dymally, Emmerson, Eng, Evans, Feuer, Fuentes,  
            Galgiani, Garcia, Hayashi, Hernandez, Horton, Houston,  
            Huffman, Jones, Karnette, Keene, Krekorian, Laird, Leno,  
            Levine, Lieber, Lieu, Ma, Mendoza, Mullin, Nakanishi,  
            Nava, Niello, Parra, Plescia, Portantino, Price, Ruskin,  
            Salas, Saldana, Smyth, Solorio, Spitzer, Swanson,  
            Torrico, Tran, Wolk, Nunez
          NOES:  Adams, Anderson, Benoit, Duvall, Fuller, Gaines,  
            Huff, Jeffries, La Malfa, Maze, Silva, Villines, Walters
          NO VOTE RECORDED: Garrick, Hancock, Sharon Runner, Soto,  
            Strickland, Vacancy


          AGB:nl  9/11/07   Senate Floor Analyses 

                         SUPPORT/OPPOSITION:  SEE ABOVE

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