BILL ANALYSIS                                                                                                                    Ó



                                                                  AB 186
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          Date of Hearing:   March 22, 2011

                            ASSEMBLY COMMITTEE ON HEALTH
                              William W. Monning, Chair
                 AB 186 (Williams) - As Introduced:  January 25, 2011
           
          SUBJECT  :  Reportable diseases and conditions.

           SUMMARY  :  Permits the California Department of Public Health 
          (DPH) to modify the list of communicable diseases and conditions 
          for which clinical labs must submit specimens to the local 
          public health laboratory to undergo further testing and allows 
          DPH to modify the list at any time in consultation with the 
          California Conference of Local Health Officers (CCLHO) and the 
          California Association of Public Health Laboratory Directors 
          (CAPHLD).  Specifically,  this bill  :  

          1)Makes legislative findings and declarations regarding the need 
            to enable prompt identification of an outbreak, send positive 
            specimens to the public health laboratory for identification, 
            and enable DPH to include newly emerging diseases and 
            conditions in a timely manner.

          2)Requires DPH to establish a list of communicable diseases and 
            conditions for which clinical laboratories shall submit a 
            culture or a specimen to the local public health laboratory to 
            undergo further study. 

          3)Permits DPH to modify the list at any time, after consultation 
            with the CCLHO and the CAPHLD, without being subject to 
            California's Administrative Procedures Act (APA), which 
            governs the adoption of regulations, but requires that DPH 
            file the revised list with the Secretary of State for 
            publication in the California Code of Regulations (CCR).

          4)Exempts clinical labs that fail to submit cultures or 
            specimens for mandatory diseases from civil and criminal 
            penalties, unless the requirement has been noticed by DPH for 
            at least six months in the CCR.

          5)Deletes specific diseases that are enumerated in law as 
            mandatory reportable diseases, thereby allowing DPH to 
            reconstitute the list in consultation with CCLHO. 

           EXISTING LAW  :  








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          1)Requires DPH to establish a list of diseases and conditions 
            which health care providers and local health officers are 
            required to report to the local public health department.  
            Allows DPH to modify this list and exempts this modification 
            from requirements, governing changes in administrative 
            regulations under APA.

          2)Under regulation, requires labs to report test results on 
            certain diseases considered to be of "public health 
            importance."

          3)Does not exempt DPH from complying with APA requirements when 
            modifying the list of reportable diseases and conditions for 
            which public health labs are required to submit specimens.  

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

           COMMENTS  :   

           1)PURPOSE OF THIS BILL  .  According to the author, technology is 
            not currently available in California public health 
            laboratories for different sub-typing techniques, such as DNA 
            fingerprinting, that can be used to identify clusters of 
            various organisms that cause illness.  The author states that 
            use of this specialized testing can help identify outbreaks 
            and sources of outbreaks so they can be mitigated, and for 
            this to be an effective public health tool, the public health 
            laboratory needs to obtain the necessary specimens from all 
            sources in order to be able to quickly identify the organisms 
            causing illnesses and compare the subtypes, thus allowing a 
            timely public health response.  The author contends that by 
            allowing DPH to quickly add conditions to the list of diseases 
            for which clinical laboratories must submit specimens, this 
            bill may save lives during an emergency.

           2)BACKGROUND  .  Health care providers who know of a case, or 
            suspected case, of any disease or condition on the DPH list 
            are required to report to the local health officer of the 
            jurisdiction where the patient resides and are required to 
            send specimens to a clinical laboratory.  Clinical 
            laboratories include all hospital laboratories and community 
            laboratories that receive tests from health care providers for 
            analysis.  Clinical laboratories are also required by 








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            regulation to report positive specimens to the local public 
            health department.  Currently laboratories are required to 
            report communicable diseases, pathogens, and viral infections. 
             Clinical laboratories are required to submit specimens for 
            those listed diseases and conditions, while specimens for 
            non-listed diseases and conditions are submitted on a 
            voluntary basis.  If there is a known or suspected outbreak of 
            a particular disease or condition that is listed, the local 
            health officer must report to DPH within a specified time 
            period, and take the necessary steps to prevent further 
            contamination or infection.  

          The list of communicable diseases and conditions for which 
            laboratories must submit cultures is established by regulation 
            and adding or deleting a disease or condition requires an 
            administrative regulation change under APA.  The APA was 
            intended to ensure transparency and full public participation 
            when agencies change their regulations.  The APA does permit 
            adoption of emergency regulations, but requires a five-day 
            public notice, and emergency regulations can only remain in 
            effect for up to 180 days.  According to the sponsor, it could 
            take one and one-half to two years for DPH to update the list 
            of reportable diseases, whereas under this, it could take as 
            little as two months.

           3)SUPPORT  .  The Health Officers Association of California 
            (HOAC), the sponsors of this bill, write that public health 
            laboratories are the front line in the war against disease 
            outbreaks.  These labs can quickly identify sub-types of 
            contaminants such as E coli so that a common source outbreak 
            can be identified and investigated.  HOAC further states that 
            public health laboratories can also examine avian flu isolates 
            for strain typing to determine their potential to result in a 
            human pandemic.  HOAC contends that this bill will enable 
            public health laboratories to better protect all Californians 
            during the outbreak of a dangerous disease.

           4)PREVIOUS LEGISLATION  .  

             a.   AB 2786 (Committee on Health) of 2010 contained 
               identical provisions to this bill.      AB 2786 was vetoed 
               by Governor Schwarzenegger, who stated in part:  "The 
               Department of Public Health, in a public health emergency, 
               already has broad authority to request and receive 
               laboratory data.  I am also concerned that the Department, 








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               without such a public health emergency, could enact changes 
               that affect both private and public laboratories without 
               any regulatory oversight."

             b.   SB 356 (Negrete McLeod) of 2007 is nearly identical to 
               this bill.  SB 356 was vetoed by Governor Schwarzenegger 
               because the delay in passing 2008-2009 State Budget forced 
               him to prioritize the bills sent to his desk.  According to 
               the Governor, SB 356 did not meet his standard as priority 
               legislation.

             c.   AB 1091 (Negrete McLeod), Chapter 262, Statutes of 2003 
               allows DPH, in consultation with the California Conference 
               of Local Health Officers, to modify the list of reportable 
               diseases that health care providers are required to report. 
                DPH can modify this list at any time without having to 
               comply with APA requirements.
           
          REGISTERED SUPPORT / OPPOSITION  :   

           Support 
           
          Health Officers Association of California (sponsor)

           Opposition 
           
          None on file. 
           

          Analysis Prepared by  :    Melanie Moreno / HEALTH / (916) 
          319-2097