BILL ANALYSIS                                                                                                                                                                                                    Ó






                             SENATE JUDICIARY COMMITTEE
                             Senator Noreen Evans, Chair
                              2013-2014 Regular Session


          AB 446 (Mitchell)
          As Amended June 17, 2013
          Hearing Date: July 2, 2013
          Fiscal: Yes
          Urgency: No
          NR


                                        SUBJECT
                                           
                                     HIV testing

                                      DESCRIPTION  

          This bill would revise the informed consent requirements when a  
          person is tested for HIV.  Specifically, this bill would: 
           expand the existing provision that persons who independently  
            request an HIV test from a medical care provider in a clinical  
            setting are exempt from the informed consent requirements, to  
            tests requested in non-clinical settings by an HIV counselor;
           require a person's independent request for an HIV test to be  
            documented by the person administering the test; 
           allow informed consent to be given orally or in writing; 
           require the person who administers a test to ensure the  
            patient receives timely information and counseling, as  
            appropriate, to explain the results and implications for the  
            patient's health; 
           would require, when a patient tests positive for HIV, the  
            person who administers the test to inform the patient that  
            there are numerous treatment options available, and identify  
            follow up testing and care that may be recommended, including  
            contact information for medical and psychological services;
           require patients between 12 and 65 years of age who have blood  
            drawn at a primary care clinic, to be offered an HIV test, as  
            specified;
           require a primary care clinic to attempt to provide test  
            results to a patient before he or she leaves the facility, but  
            would authorize the facility to inform a patient who tests  
            negative for HIV by telephone or letter, and require a  
            facility to inform a patient who tests positive for HIV in a  
            manner consistent with existing law; and
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           authorize, under specified circumstances, the result of an HIV  
            test to be posted on a secure website which can only be viewed  
            with the use of a secure code that can access a single set of  
            test results, and that is provided to the patient at the time  
            of testing, as specified. 
                                      BACKGROUND  

          According to the Centers for Disease Control and Prevention  
          (CDC), in 2010, more than 1.1 million persons 13 years of age  
          and older were living with an HIV infection in the United  
          States, including 207,600 who were unaware of their infection.  
          Over the past decade, the number of people living with HIV has  
          increased while the annual number of new HIV infections has  
          remained relatively stable, indicating that HIV testing,  
          prevention, and treatment programs are reducing the rate of  
          transmission. However, the pace of new infections continues at  
          about 50,000 infections per year.  (DHAP Annual Report, Division  
          of HIV/AIDS Prevention: Maximizing Impact,  
           [as of June 28, 2013].)

          In 2007, AB 682 (Berg, Ch. 550, Stats. 2008) was introduced to  
          facilitate routine screening for HIV in all health care  
          settings, as recommended by the CDC.  It sought to give  
          incentives to providers to comply with CDC guidelines, and make  
          HIV screening a routine part of health care delivery.  The final  
          AB 682 language, which is now law, authorized HIV testing  
          without written, informed consent in clinical settings, but  did  
          not remove the written consent requirement in non-clinical  
          settings. To address the need for more accessible testing for  
          high risk individuals, this bill would revise the existing  
          informed consent requirements, and expand the exemption from  
          written informed consent to non-clinical settings as well. 

          This bill unanimously passed out of the Senate Health Committee  
          on June 26, 2013. 

                                CHANGES TO EXISTING LAW
           
           Existing law  requires a medical care provider, prior to ordering  
          an HIV-diagnostic test, to inform the patient that the test is  
          planned, provide information about the test, inform the patient  
          that there are numerous treatment options available for a  
          patient who tests positive for HIV, that a person who tests  
          negative for HIV should continue to be routinely tested, and  
          advise the patient that he or she has the right to decline the  
                                                                      



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          test.  Existing law further provides that if a patient declines  
          the test, the medical care provider shall note that fact in the  
          patient's medical file.  (Health & Saf. Code Sec. 120990(a).)

           Existing law  prohibits a person from administering any test for  
          HIV infection unless the person being tested or his or her  
          parent, guardian, conservator, or other designee, signs a  
          written statement documenting the person's informed consent to  
          the test.  (Health & Saf. Code Sec. 120990(c).)

           Existing law  provides that the above requirements do not apply  
          when a person independently requests an HIV test from the  
          provider.  (Health & Saf. Code Sec. 120990(b).)

           Existing law  defines an HIV counselor as a person trained by the  
          Department of Public Health Office of AIDS and working in an HIV  
          counseling and testing site funded by DPH or that complies with  
          a quality assurance plan approved by the local health  
          department.  Additionally, existing law allows HIV counselors to  
          order and report HIV and other test results to patients without  
          authorization from a licensed health care professional.  (Health  
          & Saf. Code Sec. 120917(a).)

           Existing law  requires that the patient be informed that the  
          preliminary result of the HIV test is indicative of the  
          likelihood of infection, but the results must be confirmed with  
          additional testing, and further requires that patients with  
          indeterminate or positive test results be referred to an  
          appropriate licensed heath care provider.  (Health & Saf. Code  
          Sec. 120917(a).)

           Existing law  provides that, unless the patient requests the  
          disclosure or other criteria are met, an HIV antibody test and  
          any other related results shall not be disclosed to a patient by  
          Internet posting or other electronic means.  (Health & Saf. Code  
          Sec. 123148(f).)

           This bill  would require a medical care provider inform patients  
          about HIV risk reduction strategies when obtaining informed  
          consent.

           This bill  would extend a provision in existing law exempting  
          clinical settings from the informed consent requirements to a  
          requested test at an HIV counseling and testing site, as  
          specified.  This bill would also require a person's independent  
          request to be documented by the person administering the test. 
                                                                      



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           This bill  would delete the requirement that a written statement  
          documenting informed consent for an HIV test be signed, and  
          instead require the informed consent to be provided orally or in  
          writing, as specified.

           This bill  would require, after the results of a test have been  
          received, the person who administers the test to ensure that the  
          patient receives timely information and counseling, as  
          appropriate, to explain the results and implications for the  
          patient's health. 

           This bill  would require, if the patient tests positive for HIV  
          infection, the medical provider or the person who administers  
          the test to inform the patient that there are numerous treatment  
          options available, and identify follow up testing and care that  
          may be recommended, including contact information for medical  
          and psychological services. 

           This bill  would require the person who administers the HIV test,  
          if a patient tests negative for HIV infection and is known to be  
          at high risk, to advise the patient of the need for periodic  
          retesting, explain the limitations of current testing technology  
          and the current window period for verification of results. The  
          person may also offer prevention counseling or a referral to  
          prevention counseling.
           This bill  would require a patient between 12 and 65 years of age  
          who has blood drawn at a primary care clinic, who has consented  
          to the HIV test, to be offered an HIV test.  This bill would  
          also deem the primary care clinic to be in compliance with this  
          bill if it chooses to test the patient using a rapid HIV test.  

           This bill  would require a primary care clinic to attempt to  
          provide test results to a patient before he or she leaves the  
          facility. If that is not possible, this bill would authorize the  
          facility to inform a patient who tests negative for HIV by  
          letter or telephone, and would require the clinic to inform a  
          patient with a positive test result in a manner consistent with  
          existing law. 

           This bill  would authorize, under specified circumstances, the  
          result of an HIV test to be posted on a secure website which can  
          only be viewed with the use of a secure code that can access  
          only a single set of test results and is provided to the patient  
          at the time of testing.  This bill would further require the  
          test result to be posted only if there is no link to any  
                                                                      



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          information that identifies or refers to the subject of the  
          test.

                                        COMMENT
           
           1.Stated need for the bill
           
          According to the author:

            In terms of arresting the continued spread of the HIV/AIDS  
            epidemic, absolutely nothing is more important than making  
            sure all persons with HIV know their status, receive immediate  
            treatment, and practice risk reduction techniques.  The  
            provisions of AB 446 are very substantial, practical steps  
            toward furthering that objective.

           2.Removing barriers to HIV testing

           This bill seeks to remove barriers to HIV testing in clinical  
          and non-clinical settings.  In large part, this is accomplished  
          through de-exceptionalzing HIV testing, so that is as similar as  
          possible to, and can be combined with, other routine medical  
          testing.  This bill would make consent and pre-test information  
          easier to deliver, as recommended by the CDC, and move some of  
          the information that is required to be given to the patient from  
          pre-test to post-test. This bill would also encourage rapid  
          testing, and give the persons who administer an HIV test the  
          ability to post results on the Internet in a protected,  
          non-identifying form. 

          Under existing law, individuals who request an HIV test from a  
          health care provider, or "self-selecting" individuals, in a  
          clinical setting are not required to give informed consent to  
          the test.  Thus, the medical care provider is not required to  
          inform the patient that the test is planned, provide information  
          about the test, inform the patient that there are numerous  
          treatment options available for a patient who tests positive for  
          HIV, that a person who tests negative for HIV should continue to  
          be routinely tested, and advise the patient that he or she has  
          the right to decline the test.  The absence of the informed  
          consent requirement in this particular situation is justified  
          because the patient specifically asked to be tested for HIV,  
          which indicates that he or she has knowledge of the disease, and  
          the patient also has an ongoing relationship with the healthcare  
          provider who is able to follow up with the patient.  

                                                                      



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          The author notes that more and more testing is being  
          administered by HIV counselors, a profession created by statute  
          where counselors are trained and certified by the state. These  
          counselors, however, give tests in non-clinical settings, and  
          are therefore subject to different informed consent standards.  
          The sponsor argues that "requiring HIV counselors to seek a more  
          rigid form of consent undermines their ability to provide  
          testing services to people who are out-of-sync with traditional  
          health care delivery.  The potential test subjects who visit  
          these community non-clinical settings often have to be convinced  
          to have the test in the first place, and are more likely to skip  
          the test altogether the longer they are required to remain with  
          the HIV counselor, especially if they have to sign a consent  
          form."

          Accordingly, this bill would make consent requirements for  
          self-selecting patients similar whether in a clinical or  
          non-clinical setting, and would allow informed consent for  
          non-self-selecting patients, to be given orally or in writing.   
          This bill would also encourage more routine testing of patients  
          by requiring that medical care providers offer an HIV test to  
          any patient, between the age of 12 and 65, who has blood drawn  
          at a primary care clinic. Additionally, this bill would  
          explicitly authorize the clinic to use the rapid HIV test.

           3.Initial concerns have been addressed by prior amendments

           As introduced, this bill had a lengthy list of opposition from  
          various groups.  The author has worked diligently with  
          stakeholders to remove that opposition.  Specifically, prior  
          versions of this bill would have required all emergency rooms  
          and urgent care clinics to offer an HIV test whenever a patient  
          had blood drawn.  

          This requirement was met with strong opposition from hospitals,  
          physicians, and other groups. In opposition, the California  
          Occupational Medicine Physicians wrote "many of our occupational  
          clinics not only treat injured workers but also offer urgent  
          care services for non-occupational conditions.  We have concerns  
          ?that these requirements would require an occupational physician  
          after the results of the test come back, regardless of the  
          result, to give the patient timely information and counseling."   
          Echoing this concern that emergency clinics are not well suited  
          for the sort of counseling required by HIV testing, the  
          California Society of Pathologists "while we share your concerns  
          with improved detection and treatment for HIV, the practical  
                                                                      



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          issues ? are substantial and we must therefore oppose those  
          provisions."  The bill was subsequently amended to remove the  
          requirement that HIV tests be offered and given in emergency  
          rooms and urgent care clinics. 

          In addition, the American Civil Liberties Union led a coalition  
          of stakeholders who opposed prior versions of this bill.  They  
          argued that it eroded informed consent in both the clinical and  
          non-clinical setting, eliminated documented consent for HIV  
          testing, and failed to provide linkages to care for those who  
          test HIV-positive.  Working closely with these stakeholders, the  
          author has taken amendments to remove their concerns including:  
          (1) requiring documentation of a person's consent to HIV  
          testing; (2) requiring the person who administers the test to  
          ensure the patient receives timely information and counseling to  
          explain the results and implications of the test; and (3)  
          ensuring that a patient who tests positive for HIV is given  
          information about treatment options and the contact information  
          for medical and psychological services. 
           
          The author agreed to three additional amendments in the Senate  
          Health Committee which removed all remaining opposition.  Those  
          amendments:  (1) removed the requirement that prior to testing,  
          a medical care provider discuss risk reduction strategies; (2)  
          added the requirement that a medical care provider inform a  
          person who tests negative for HIV that he or she should continue  
          to be tested; and (3) corrected a technical error. 

             Author's amendments:

              1.   On page 2, lines 6 and 7, delete "and risk reduction  
               strategies"

             2.   On page 2, line 8, after "HIV" insert "and that a person  
               who tests negative for HIV should continue to be routinely  
               tested"

             3.   On page 4, line 7, delete "adminsters" and insert  
               "administers"


           Support  :  Beyond AIDS; Black AIDS Institute; Black Women for  
          Wellness California Communities United Institute

           Opposition  :  None Known

                                                                      



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                                        HISTORY
           
           Source  :  AIDS Healthcare Foundation

           Related Pending Legislation  : AB 506 (Mitchell) would authorize  
          social workers to consent to HIV testing for infants in  
          temporary custody, or who are adjudicated dependents, when such  
          testing is determined to be medically necessary and the parent  
          or guardian cannot be reached.  This bill is currently on the  
          Senate Floor.
           
          Prior Legislation  :

          AB 491 (Portantino, 2011) would have allocated state and federal  
          funds to test persons for HIV, would have specified that an HIV  
          counselor is a medical care provider, and would have authorized  
          a clinical laboratory test result of a negative HIV antibody  
          test to be posted on a secure website if specified conditions  
          were met.  AB 491 was amended to deal with a different subject  
          matter.

          AB 1894 (Krekorian, Chapter 631, Statutes of 2008) required  
          health care service plans and disability insurers selling health  
          insurance to offer testing for HIV and AIDS, regardless of  
          whether the testing is related to a primary diagnosis.

          AB 682 (Berg, Chapter 550, Statutes of 2007) revised the written  
          and informed consent standards associated with testing blood for  
          HIV, including prenatal HIV testing.

           Prior Vote  :

          Senate Health Committee (Ayes 9, Noes 0)
          Assembly Floor (Ayes 72, Noes 1)
          Assembly Appropriations Committee (Ayes 16, Noes 1)
          Assembly Health Committee (Ayes 18, Noes 0)
          Assembly Judiciary Committee (Ayes 10, Noes 0)

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