BILL ANALYSIS                                                                                                                                                                                                    



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          Date of Hearing:  April 14, 2015


                            ASSEMBLY COMMITTEE ON HEALTH


                                  Rob Bonta, Chair


          AB 170  
          (Gatto) - As Amended March 25, 2015


          SUBJECT:  Newborn screening:  genetic diseases:  blood samples  
          collected


          SUMMARY:  Prohibits the Department of Public Health (DPH) from  
          testing a newborn child and retaining a blood sample for medical  
          research unless the parent or guardian provides informed  
          consent, as specified.  Specifically, this bill:


          1)Prohibits DPH from testing a newborn child unless the parent  
            or guardian provides informed consent, as specified.



          2)Prohibits DPH from storing, retaining, or using for medical  
            research a blood sample collected unless the parent or  
            guardian provides informed consent, as specified.



          3)Authorizes a parent or guardian of a minor child and the  
            newborn child, once he or she is at least 18 years of age, to  
            request that DPH destroy or not use for research purposes, or  
            both, the blood sample.









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          4)Requires DPH to destroy blood samples if an individual that  
            has reached at least 18 years of age, or a parent or guardian  
            of a minor child, requests DPH to do so.



          5)Requires DPH to prepare and provide informational materials  
            regarding the newborn child blood samples collected that  
            includes, but is not limited to, information on storage,  
            retention, and use of the blood sample, and the right of  
            specified persons to request that the blood sample be  
            destroyed or not used for research purposes, or both.



          6)Requires DPH to prepare and provide a standard informed  
            consent form, to be distributed as specified, that includes an  
            explanation of the newborn child screening test and a space  
            for the parent or legal guardian of the newborn child to  
            indicate his or her consent to the storage, retention, and use  
            of the blood sample for medical research.  
          EXISTING LAW:  


          1)Requires DPH to establish a genetic disease unit to coordinate  
            all DPH programs in the area of genetic disease that will  
            promote a statewide program of information, testing, and  
            counseling services and to have the responsibility of  
            designating tests and regulations to be used in executing this  
            program and to have the responsibility of designating tests  
            and regulations to be used in executing the California Newborn  
            Screening Program (CNSP). 

          2)Requires DPH to provide genetic screening and follow-up  
            services.  Allows DPH to provide laboratory (lab) testing  
            facilities or work with qualified outside labs to conduct  
            testing.








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          3)Requires DPH to charge a fee for newborn screening and  
            follow-up services, and requires the amount of the fee to be  
            periodically adjusted in order to meet the costs of CNSP. 

          4)Requires DPH to 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.  Requires DPH to  
            also evaluate and prepare recommendations on the availability  
            and effectiveness of preventative follow-up interventions,  
            including the use of specialized medically necessary dietary  
            products.  

          5)Requires statewide screening of newborns to include tandem  
            mass spectrometry screening for fatty acid oxidation, amino  
            acid, and organic acid disorders and congenital adrenal  
            hyperplasia.  Also requires screening of newborns to include  
            screening for severe combined immunodeficiency, as soon as  
            possible.

          FISCAL EFFECT:  This bill has not yet been analyzed by a fiscal  
          committee.


          COMMENTS: 


          1)PURPOSE OF THIS BILL.  According to the author, newborn  
            screening is one of the great public health success stories in  
            this country, but what happens to the samples after the  
            screening process is completed raises serious and troubling  
            questions of consent and privacy. In the case of California  
            and a handful of other states, these samples are indefinitely  
            stored in state repositories and made available to researchers  
            for a fee.  The author states that most parents are poorly  
            informed, if at all, about the storage and medical research of  
            these samples.









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          The author argues that parents are assumed to have consented to  
            long-term storage and third-party use of their child's  
            biological sample unless they explicitly refuse in writing.  
            California must revise its approach to long-term storage and  
            use of newborn DNA samples, and include parents in the  
            decision-making process.  It is imperative for both the health  
            of this program and Californians' continued trust in their  
            government that parents be fully informed of the Biobank  
            program and the intended future use of their child's DNA.

          The author concludes that this bill will ensure that parents  
            have the right to protect their children's genetic privacy.   
            Parents, understandably, want to be actively involved in  
            decision-making regarding their children's personal health  
            information.  That choice is currently being denied.

          2)BACKGROUND.  In 1966 California began its CNSP with the  
            testing of phenylketonuria.  Since its creation, the CNSP has  
            been expanded several times as new discoveries are made and  
            tests developed and now screens for more than 70 disorders.   
            Diseases have been added through regulation and legislation.

             a)   CNSP.  Prior to leaving the hospital, a few drops of  
               blood from the newborn's heel are collected on filter  
               paper.  The newborn screening test should be done when the  
               baby is at least 12 hours of age but before six days of  
               age.  The ideal time to do the test is when the baby is  
               between 24 and 48 hours of age.  Blood collected before 12  
               hours of age is not always reliable for some metabolic  
               diseases.  The sample is sent to one of eight regional labs  
               that contract with the DPH for testing.  The results are  
               sent to DPH for data collection and quality control.   
               Parents obtain the test results from the baby's doctor or  
               clinic.  It takes about two weeks for the doctor to receive  
               the written results.  If the baby needs more tests, parents  
               get a letter or a phone call a few days after discharge  
               from the hospital.  Positive test results are immediately  
               telephoned to a follow-up coordinator at one of the Newborn  
               Screening Area Service Centers throughout the State.  The  








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               coordinator contacts the newborn's physician to arrange for  
               repeat testing.  If repeat testing determines that the baby  
               has a disorder, the coordinator will supply the latest  
               clinical information on diagnosis and treatment and assist  
               with referrals to special care.  In 2009-10, approximately  
               520,000 newborns were screened for 75 genetic disorders.   
               Approximately 9,200 or under 2% were classified as positive  
               or questionable and were referred for follow-up testing or  
               services. 

             Disorders screened for by the CNSP have varying degrees of  
               severity.  If identified early many of these conditions can  
               be treated before they cause serious health problems.   
               Treatments may include medication, dietary supplements,  
               avoidance of fasting and/or special diet and comprehensive  
               care to reduce morbidity and mortality.  This test screens  
               for specific diseases in the following groups:

               i)     Metabolic: chemical reactions in the body to create  
                 energy and build tissue;
               ii)    Endocrine: hormones that affect body functions;


               iii)   Hemoglobin: red blood cells that carry oxygen;


               iv)    Other Genetic Diseases;


               v)     Cystic Fibrosis; and,


               vi)    Severe Combined Immunodeficiency.



          CNSP disorders cause delays in development, neurological damage,  
          dehydration, incorrect sex assignment, mental retardation, and  
          death if not treated at an early newborn age.  In California  








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          about one out of every 600 babies tested will have one of these  
          diseases.



          Current regulations permit a parent to decline the test.  A  
          parent must then sign a special form that states that not having  
          the test done can result in serious illness or permanent damage  
          to their child.  It also states that the parent must accept  
          responsibility should this occur.



             b)   California BioBank.  DPH maintains a large and diverse  
               biobank, the California Biobank Program, which houses over  
               17.5 million prenatal serum samples and newborn leftover  
               blood spots.  These samples were collected for testing by  
               the Prenatal and Screening Program and CNSP that are  
               administered by the Genetic Disease Screening Program  
               (GDSP) and are linked to GDSP data and California Birth  
               Defects Monitoring Program (CBDMP) registry data.  The  
               samples and data are also linked to the State Registrar of  
               Vital Statistics databases that include fetal death, live  
               birth and death data.  The California Biobank Program (CBP)  
               is an internationally recognized public health asset  
               because of its large size and culturally, geographically  
               and genetically diverse population.  The CBP is unique in  
               that no other state or international effort approaches its  
               scale in terms of the number and quality of specimens  
               collected and preserved annually, the number of historic  
               specimens, and existing linkage with statewide prenatal and  
               newborn screening program data, birth defects data, CBDMP  
               data and other population databases.

          3)OPPOSITION.  The California Hospital Association (CHA),  
            California Healthcare Institute, Advanced Medical Technology  
            Association, and Biocom write in opposition to the bill that  
            the net result of this bill would be to decrease the number of  
            newborns tested for these devastating disorders which can be  








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            prevented or ameliorated if detected.  Opponents write that  
            the mothers who are most likely to decline the testing are  
            those without insurance or with high deductibles, and mothers  
            who are inordinately suspicious of government while other  
            mothers might decline testing due to their lack of  
            understanding of science and medicine.  CHA further states  
            that this bill would also increase the administrative burdens  
            on hospitals, physicians, and new mothers which, in turn, will  
            increase health care costs.  Finally, according to the  
            opposition, this bill bill would increase the legal liability  
            on hospitals and physicians; if a mom opts out of testing her  
            baby, and her baby has one of these devastating disorders  
            which could have been detected, she will likely sue physician  
            and/or hospital. 

          The University of Southern California states in opposition that  
            the current California blood spot database serves as an  
            important resource to assist in the early identification of  
            these rare diseases.  California's database is internationally  
            recognized as a critical public health asset and allows for  
            the study of these rare diseases among its diverse  
            communities.

          The American Academy of Pediatrics, California and March of  
            Dimes California Chapter (March of Dimes) writes in opposition  
            that they oppose any amendments that would link consent for  
            storage and research of newborn screening blood spots with the  
            initial collection and testing of the blood spots.  March of  
            Dimes recognizes both the value of newborn screening blood  
            spots for research use by the scientific community and the  
            importance of appropriate parental involvement in decisions  
            regarding storage and use of post-screening blood spots.   
            However, the March of Dimes overriding interest is to  
            safeguard the benefit to newborns of early detection of  
            conditions that seriously threaten their lives or health and  
            the initiation of treatment that is made possible by timely  
            newborn screening.

          The California Children's Hospital Association (CCHA) writes  








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            with concerns about this bill, stating that the current  
            California blood spot database is an internationally  
            recognized public health asset because of its size and  
            diversity.  The ability to study rare diseases, diseases  
            contained to small geographical areas or to small subsets of  
            California's genetically diverse population, as well as the  
            ability to link clinical and environmental data (such as  
            pesticides), would not be possible without California's blood  
            spot database.  Implementing an informed consent policy will  
            require significant financial resources to address education  
            of families, training for health care providers in  
            distributing and explaining the consent forms, logistics and  
            follow-up (e.g. destruction of blood spots).  Given that the  
            federal Common Rule must be finalized by the end of 2016 and  
            will then govern these processes for the majority of research  
            in California, it would be best to ensure that state law is  
            congruent with federal policy. Currently, this bill would move  
            ahead with changes to state law that could be in conflict with  
            the final version of the federal regulations.

          CCHA concludes that under the legislation as written, parents  
            could receive the consent form twice or more, with the  
            potential for them to change their decision in between.  This  
            could lead to confusion at CDPH or the hospital gathering the  
            consent forms.  This bill should contain some guidance about  
            how to handle this conflict.

          4)CONCERN.  The University of California (UC) writes with  
            concerns that this measure could significantly limit the  
            availability of the valuable data and biosamples collected by  
            the CNSP for research use.  One of the greatest values of  
            California's current process for collecting and storing  
            newborn dried blood samples comes from its size and diversity.  
             The samples stored by DPH reflect California's diverse  
            population and allows us to research how different diseases  
            affect different ethnicities.  The sheer number of samples  
            makes research into rare diseases possible, and also  
            facilitates robust studies of regional environmental factors  
            that can cause disease.  This bill's revised process for  








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            research use of newborn dried blood samples is likely to  
            severely limit the number of samples that may be collected  
            which in turn, would greatly diminish the research value of  
            the current newborn dried blood samples stored by DPH.  The UC  
            indicates concern that the bill's research terminology is  
            inconsistent with the Federal Policy for the Protection of  
            Human Subjects, or the "Common Rule."  The common rule is  
            utilized by all Human Subject Protection Programs for  
            federally-funded research.  The UC worries that the revised  
            consent process under this bill may confuse new parents  
            instead of creating a greater understanding about the benefits  
            of the NSP and the research it supports.

          5)PREVIOUS LEGISLATION.



             a)   AB 1559 (Pan), Chapter 565, Statutes of 2014, expands  
               DPH statewide screening of newborns to include screening  
               for adrenoleukodystrophy (ALD) as soon the federal  
               Recommended Uniform Screening Panel approved the addition  
               of ALD.



             b)   SB 222 (Padilla) of 2014 would have enacted the Genetic  
               Information Privacy Act, which would have required an  
               individual's written authorization prior to the collection  
               of genetic information for testing, analysis, retention or  
               disclosure.  SB 222 was held in the Senate Appropriations  
               Committee. 



             c)   SB 1267 (Padilla) of 2012 would have required an  
               individual's written authorization prior to the collection  
               of genetic information for testing, analysis, retention or  
               disclosure.  The bill would have required destruction of  
               the genetic information upon completion of the purpose  








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               authorization was obtained.  SB 1267 was held in the Senate  
               Appropriations Committee.  



             d)   SB 1731 (Block), Chapter 336, Statutes of 2012,  
               established the Newborn Critical Congenital Heart Disease  
               (CCHD) Screening  Program and required hospitals, beginning  
               July 1, 2013, to offer a pulse oximetry test for the  
               identification of CCHD to parents of newborns prior to  
               discharge.



             e)   AB 395 (Pan), Chapter 461, Statutes of 2011, expands  
               statewide screening of newborns to include screening for  
               severe combined immunodeficiency. 



             f)   SB 1103 (Committee on Budget and Fiscal Review), Chapter  
               228, Statutes of 2004, expands statewide screening of  
               newborns to include tandem mass spectrometry screening for  
               fatty acid oxidation, amino acid, organic acid disorders,  
               and congenital adrenal hyperplasia. 



             g)   AB 442 (Committee on Budget), Chapter 1161, Statutes of  
               2002, requires hospitals to collect fees associated with  
               any tests conducted under CNSP.



             h)   SB 537 (Greene), Chapter 1011, Statutes of 1998,  
               required DPH to establish a program to provide extended  
               newborn genetic screening services for persons who elect to  
               have, and pay for, the additional screening.  
          6)COMMITTEE AMENDMENTS.  The CNSP program is crucial to  








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            protecting each newborn from identifiable and preventable  
            diseases.  Approximately 10,000 newborn screenings per year  
            are classified as positive or questionable and are referred  
            for follow-up testing or services.  Potentially saving the  
            lives of 10,000 babies outweighs any privacy protections that  
            parents may lay claim to.  For this reason, the Committee  
            suggests amendments that remove any opt-in requirements to  
            have a newborn screened at birth.  

          On page 3, strike lines 29-34, and replace it with: 


          (d) This section shall not apply if a parent or guardian of the  
          newborn child objects to a test.
            The Committee is sympathetic towards the many concerns raised  
            by the opposition and scientific community regarding opt-in  
            requirements to have dried blood spot samples stored and used  
            for research.  Because the potential impacts on research are  
            uncertain, the Committee may wish to make an amendment that  
            would sunset these provisions of this bill.


          On page 5, line 19 add:


          (k) Section 125000 (d) (2) shall be repealed on January 1, 2022.


           


          On page 7, line 32 add:


          (e) Section 125004 (a) (4) and (6) (b) shall be repealed on  
          January 1, 2022. 


          REGISTERED SUPPORT / OPPOSITION: 








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          Support




          American Federation of State, County and Municipal Employees


          Opposition


          Advanced Medical Technology Association
          American Academy of Pediatrics, California
          Biocom
          California Children's Hospital Association
          California Healthcare Institute
          California Hospital Association
          March of Dimes California Chapter
          University of Southern California
          Analysis Prepared by:Paula Villescaz / HEALTH / (916) 319-2097