BILL ANALYSIS                                                                                                                                                                                                    Ó

          |SENATE RULES COMMITTEE            |                        SB 361|
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                                UNFINISHED BUSINESS 

          Bill No:  SB 361
          Author:   Hill (D), et al.
          Amended:  8/27/15  
          Vote:     27  - Urgency

           SENATE HEALTH COMMITTEE:  9-0, 4/8/15
           AYES:  Hernandez, Nguyen, Hall, Mitchell, Monning, Nielsen,  
            Pan, Roth, Wolk


           SENATE FLOOR:  35-0, 4/30/15
           AYES:  Allen, Anderson, Bates, Beall, Berryhill, Block,  
            Cannella, De León, Fuller, Gaines, Galgiani, Hall, Hancock,  
            Hertzberg, Hill, Hueso, Huff, Jackson, Lara, Leno, Leyva, Liu,  
            McGuire, Mendoza, Mitchell, Monning, Moorlach, Nguyen,  
            Nielsen, Pan, Pavley, Roth, Stone, Wieckowski, Wolk
           NO VOTE RECORDED:  Hernandez, Morrell, Runner, Vidak

           ASSEMBLY FLOOR:  79-0, 8/31/15 - See last page for vote
           SUBJECT:   Antimicrobial stewardship: education and policies

          SOURCE:    Author

          DIGEST:   This bill requires skilled nursing facilities to adopt  
          and implement an antimicrobial stewardship policy by January 1,  

          Assembly Amendments require a licensed veterinarian to complete  


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          a minimum of one credit hour of continuing education on the  
          judicious use of medically important antimicrobial drugs every  
          four years as part of his or her continuing education  
          requirements, and made minor, conforming changes related to the  
          required antimicrobial stewardship policies of skilled nursing  


          Existing law:

          1)Provides for the licensure and regulation of health facilities  
            by the Department of Public Health (DPH), including skilled  
            nursing facilities (SNFs), which are defined as health  
            facilities that provide skilled nursing care and supportive  
            care to patients whose primary need is for availability of  
            skilled nursing care on an extended basis.

          2)Requires general acute care hospitals, by July 1, 2015, to  
            adopt and implement an antimicrobial stewardship policy in  
            accordance with guidelines established by the federal  
            government and professional organizations; develop a physician  
            supervised multidisciplinary antimicrobial stewardship  
            committee, subcommittee, or workgroup; and report  
            antimicrobial stewardship program activities to each  
            appropriate hospital committee undertaking clinical quality  
            improvement activities.

          3)Licenses and regulates veterinarians by the Veterinary Medical  
            Board, and requires veterinarians to complete a minimum of 36  
            hours of continuing education in the preceding two years in  
            order to have their licenses renewed.
          This bill:

          1)Requires SNFs, by January 1, 2017, to adopt and implement an  
            antimicrobial stewardship policy that is consistent with  
            antimicrobial stewardship guidelines developed by the federal  
            Centers for Disease Control and Prevention, the federal  
            Centers for Medicare and Medicaid Services, the Society for  


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            Healthcare Epidemiology of America, or similar recognized  
            professional organizations.

          2)Specifies that failure of a SNF to comply with the provisions  
            of this bill may subject the SNF to citation and civil penalty  
            provisions in existing law.

          3)Requires, on or after January 1, 2018, a licensed veterinarian  
            who renews his or her license to complete a minimum of one  
            credit hour of continuing education on the judicious use of  
            medically important antimicrobial drugs, as defined, every  
            four years as part of his or her continuing education  

          4)Contains an urgency clause that will make this bill effective  
            upon enactment.

          1)Author's statement.  The overuse and misuse of antibiotics in  
            nursing homes can lead to the development of antibiotic  
            resistant infections. Antibiotic resistance is a national and  
            worldwide public health threat. The Centers for Disease  
            Control and Prevention (CDC) estimates that each year at least  
            2 million Americans are infected with - and at least 23,000  
            Americans die from - antibiotic resistant infections. Each  
            year, antibiotic resistant infections result in at least $20  
            billion in direct health care costs and at least $35 billion  
            in lost productivity in the United States.  A recent study  
            commissioned by the United Kingdom determined that by 2050,  
            worldwide, more people will die from antibiotic resistant  
            infections than from cancer. The overuse and misuse of  
            antibiotics in human medicine is a major driver of antibiotic  
            resistance. The CDC reports that "up to 50 percent of all the  
            antibiotics prescribed for people are not needed or are not  
            optimally effective as prescribed."  For example, antibiotics  
            are sometimes prescribed when no infection is present or the  
            wrong antibiotic may be given to treat a certain infection.  
            Nationwide, up to 70 percent of nursing home residents receive  
            an antibiotic every year and 27,000 acquire antibiotic  
            resistant infections. Studies suggest that between 25 and 75  
            percent of antibiotic use in long-term care settings may be  


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            inappropriate, contributing to the prevalence of antibiotic  
            resistance. Antibiotic stewardship programs are an effective  
            way to promote judicious antibiotic use and reduce antibiotic  
            resistance. Last year, SB 1311 (Hill), Chapter 843, Statutes  
            of 2014 was signed into law, requiring antibiotic stewardship  
            programs at all California hospitals. However, this  
            requirement does not extend to SNFs.

          2)Background.  According to the CDC, antibiotic resistance is a  
            quickly growing, extremely dangerous problem. World health  
            leaders have described antibiotic-resistant bacteria as  
            "nightmare bacteria" that "pose a catastrophic threat" to  
            people in every country in the world.  Most infections occur  
            in the community, like skin infections with  
            Methicillin-resistant Staphylococcus aureus (MRSA) and  
            sexually transmitted diseases. However, most deaths related to  
            antibiotic resistance occur from drug-resistant infections  
            picked up in healthcare settings, such as hospitals and  
            nursing homes.  According to a February 2013 joint letter from  
            the Infectious Diseases Society of America (IDSA) and the  
            Society for Health Epidemiology of America (SHEA) to the  
            National Quality Forum, ample data exist from both inpatient  
            and outpatient settings demonstrating that antibiotics are  
            often prescribed sub-optimally or inappropriately. Antibiotics  
            are misused in a variety of ways. They are often administered  
            when they are not needed, continued when they are no longer  
            necessary, or prescribed at the wrong dose. Broad-spectrum  
            agents may be used unnecessarily against bacteria that are  
            very susceptible or the wrong antibiotic may be given to treat  
            a particular infection.  Over the past 30 years, bacteria that  
            are extremely resistant to traditional treatments or resistant  
            to multiple drugs have spread widely among patients in  
            healthcare settings. In some cases these pathogens have been  
            pan-resistant, meaning that they are resistant to all  
            available antibiotics. The unique nature of antibiotics, in  
            which the use of the drugs in one patient can impact the  
            effectiveness of the drug in a different patient, make  
            antibiotic overuse a serious patient safety issue and public  
            health threat.  The World Health Organization has  
            characterized antibiotic resistance as "a crisis that has been  
            building up over decades, so that today common and  
            life-threatening infections are becoming difficult or even  


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            impossible to treat." Resistant infections not only result in  
            increased morbidity and mortality, but increased economic  
            burdens. For example, studies have shown that  
            antibiotic-resistant infections are associated with longer  
            lengths of stay and increased mortality, both in the hospital  
            and in intensive care units. 

          3)Presidential Executive Order. In September of 2014, President  
            Obama issued an executive order, titled "Combating  
            Antibiotic-Resistant Bacteria." Among other things, this  
            executive order requires the Health and Human Services Agency,  
            by the end of calendar year 2016, to review existing  
            regulations and propose new regulations or other actions, as  
            appropriate, that require hospitals and other inpatient  
            healthcare delivery facilities to implement robust antibiotic  
            stewardship programs that adhere to best practices, such as  
            those identified by the CDC. The executive order also  
            established a federal task force that is required to, as  
            appropriate, define, promulgate, and implement stewardship  
            programs in other healthcare settings, including office-based  
            practices, outpatient settings, emergency departments, and  
            institutional and long-term care facilities, such as nursing  
            homes, pharmacies, and correctional facilities.

          4)California's program.   In February 2010, the DPH Healthcare  
            Associated Infection (HAI) Program developed a statewide  
            antimicrobial stewardship program (ASP) initiative in order to  
            strengthen and promote optimization of antimicrobial  
            utilization in California health care facilities. According to  
            DPH, the purpose of an antimicrobial stewardship program in a  
            healthcare facility is to measure and promote the appropriate  
            use of antimicrobials by selecting the appropriate agent,  
            dose, duration and route of administration in order to improve  
            patient outcomes, while minimizing toxicity and the emergence  
            of antimicrobial resistance. Although guidelines exist for  
            developing ASPs, there is limited information on practical  
            implementation of these guidelines, particularly in  
            resource-limited settings.  According to DPH, its partners in  
            this statewide initiative include the Division of Healthcare  
            Quality and Promotion at CDC, Infectious Disease Association  
            of California, and SHEA.  According to the DPH website,  
            current program activities include:


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             a)   The HAI Program has launched a statewide Antimicrobial  
               Stewardship Program Collaborative, with the goal of  
               ensuring that all California hospitals have a functional  
               and robust ASP to promote patient safety and to decrease  
               antimicrobial resistance. The Collaborative will extend for  
               one year from January through December 2015;
             b)   Spotlight on ASP Project, which helps define  
               antimicrobial stewardship programs and activities, and  
               spotlights volunteer hospitals that want to highlight and  
               share with others their ASP progress; 
             c)   Utilization of a statewide assessment of ASPs present in  
               California healthcare facilities (May 2010 - March 2011) to  
               develop evidence-based recommendations on how to implement  
               or strengthen ASPs given available resources and facility  
             d)   Developing recommendations with the Antimicrobial  
               Stewardship Subcommittee of the California HAI Advisory  
             e)   Defining activities that comprise ASPs in California  
               hospitals; and,
             f)   The California Antibiogram Project, which collects  
               information on specific antimicrobial-organism combinations  
               across California general acute care hospitals.

          Prior Legislation

          SB 1311 (Hill, Chapter 843, Statutes of 2014) required general  
          acute care hospitals, by July 1, 2015, to adopt and implement an  
          antimicrobial stewardship policy, as specified; develop a  
          physician supervised multidisciplinary antimicrobial stewardship  
          committee, subcommittee, or workgroup; appoint at least one  
          physician or pharmacist who has attended training specifically  
          on antimicrobial stewardship to the committee, subcommittee, or  
          workgroup, as specified; and, report antimicrobial stewardship  
          program activities to appropriate hospital committees, as  
          SB 158 (Florez, Chapter 294, Statutes of 2008) established an  
          infection surveillance, prevention, and control program within  
          DPH to provide oversight of hospital prevention and reporting of  
          general acute care hospital-associated infections, expanded the  


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          responsibilities of DPH's HAI Advisory Committee, and requires  
          all hospitals to institute a patient safety plan for the purpose  
          of improving the health and safety of patients and reducing  
          preventable patient safety events.

          SB 1058 (Alquist, Chapter 296, Statutes of 2008) established the  
          Medical Facility Infection Control and Prevention Act, which  
          requires hospitals to implement specified procedures for  
          screening, prevention, and reporting specified health care  
          associated infections also known as HAIs. Requires hospitals to  
          report positive MRSA and other HAI test results to DPH and  
          requires DPH to make specified information public on its  
          SB 739 (Speier, Chapter 526, Statutes of 2006) created a state  
          HAI advisory committee to make recommendations regarding  
          reporting cases of HAI in hospitals.  Requires each general  
          acute care hospital, after January 1, 2008, to implement and  
          annually report to DPH its implementation of infection  
          surveillance and infection prevention process measures that have  
          been recommended by CDC Healthcare Infection Control Practices  
          Advisory Committee, as suitable for a mandatory public reporting  
          program. Required, initially, these process measures to include  
          the CDC guidelines for central line insertion practices,  
          surgical antimicrobial prophylaxis, and influenza vaccination of  
          patients and healthcare personnel. Requires DPH, in consultation  
          with the HAI advisory committee, to make this information public  
          no later than six months after receiving the data. Required that  
          general acute care hospitals develop a process for evaluating  
          the judicious use of antibiotics, the results of which shall be  
          monitored jointly by appropriate representatives and committees  
          involved in quality improvement activities.

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

          According to the Assembly Appropriations Committee:
          1)Minor and absorbable costs to the Licensing and Certification  
            division of the California Department of Public Health (CDPH)  
            to verify SNF compliance with the new antimicrobial  
            stewardship policy requirement during the course of routine  


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            inspections or on a complaint basis (Licensing and  
            Certification Fund). 

          2)Minor and absorbable costs to the Veterinary Medical Board to  
            approve required courses and verify compliance with the new CE  
            requirement (Veterinary Medical Board Fund). 

          3)Potential unknown, likely minor information technology costs  
            to both departments for system modifications to capture the  
            new requirements (Licensing and Certification Fund /Veterinary  
            Medical Board Contingent Fund).

          SUPPORT:   (Verified8/31/15)

          Blue Shield of California
          California Children's Hospital Association
          California Long-Term Care Ombudsman Association
          California Naturopathic Doctors Association
          California Optometric Association
          California Society of Health-System Pharmacists
          California Veterinary Medical Association
          Health Officers Association of California

          OPPOSITION:   (Verified8/31/15)

          None received

          ARGUMENTS IN SUPPORT:      This bill is supported by CALPIRG,  
          which states that 70 percent of nursing home residents  
          nationwide receive an antibiotic every year, and 27,000  
          residents acquire antibiotic resistant infections. According to  
          CALPIRG, studies suggest that between 25 and 75 percent of  


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          antibiotics prescribed in long-term care facilities may be  
          inappropriate. CALPIRG states that it is hopeful that the  
          development and enforcement of these guidelines will reduce the  
          unnecessary use of antibiotics in nursing homes, helping to  
          prevent the spread of antibiotic resistant bacteria. Blue Shield  
          of California states in support that it has been well document  
          by the CDC that antibiotics are being grossly overused in  
          nursing homes. Blue Shield notes that antibiotic resistant  
          infections require prolonged and costlier treatments, extend  
          hospital stays, necessitate additional doctor visits and  
          healthcare use, and result in greater disability and death  
          compared with infections that are easily treatable with  
          antibiotics. The California Long-Term Care Ombudsman Association  
          states that the current practice of giving residents medications  
          prior to confirmation or test results recommending such  
          medications puts residents at risk due to an increase in  
          antimicrobial resistant infections, and this bill is an  
          appropriate solution to this problem.

           ASSEMBLY FLOOR:  79-0, 8/31/15
           AYES: Achadjian, Alejo, Travis Allen, Baker, Bigelow, Bloom,  
            Bonilla, Bonta, Brough, Brown, Burke, Calderon, Campos, Chang,  
            Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle,  
            Daly, Dodd, Eggman, Frazier, Beth Gaines, Gallagher, Cristina  
            Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gray,  
            Grove, Hadley, Harper, Roger Hernández, Holden, Irwin, Jones,  
            Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low,  
            Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin,  
            Nazarian, Obernolte, O'Donnell, Olsen, Patterson, Perea,  
            Quirk, Rendon, Ridley-Thomas, Rodriguez, Salas, Santiago,  
            Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber,  
            Wilk, Williams, Wood, Atkins
           NO VOTE RECORDED: Gordon

           Prepared by:Vince Marchand / HEALTH / 
          8/31/15 18:47:13


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