BILL ANALYSIS Ó ----------------------------------------------------------------- |SENATE RULES COMMITTEE | SB 1311| |Office of Senate Floor Analyses | | |1020 N Street, Suite 524 | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ----------------------------------------------------------------- UNFINISHED BUSINESS Bill No: SB 1311 Author: Hill (D), et al. Amended: 8/7/14 Vote: 21 SENATE HEALTH COMMITTEE : 8-0, 4/24/14 AYES: Hernandez, Morrell, Beall, DeSaulnier, Evans, Monning, Nielsen, Wolk NO VOTE RECORDED: De León SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8 SENATE FLOOR : 35-0, 5/8/14 (Consent) AYES: Anderson, Beall, Berryhill, Block, Cannella, Corbett, Correa, De León, DeSaulnier, Evans, Fuller, Galgiani, Hancock, Hernandez, Hill, Hueso, Huff, Jackson, Lara, Leno, Lieu, Liu, Mitchell, Monning, Morrell, Nielsen, Padilla, Pavley, Roth, Steinberg, Torres, Vidak, Walters, Wolk, Wyland NO VOTE RECORDED: Calderon, Gaines, Knight, Wright, Yee ASSEMBLY FLOOR : 78-0, 8/11/14 - See last page for vote SUBJECT : Hospital: antimicrobial stewardship SOURCE : Author DIGEST : This bill requires all general acute care hospitals, as defined, to adopt and implement, by July 1, 2015, an antimicrobial stewardship policy, that includes a process to evaluate the judicious use of antibiotics, as specified. This CONTINUED SB 1311 Page 2 bill requires a general acute care hospital to develop a physician-supervised multidisciplinary antimicrobial stewardship committee, subcommittee, or workgroup, and to appoint at least one physician or pharmacist who is knowledgeable about antimicrobial stewardship through prior training or attendance at continuing education programs. This bill also requires a general acute care hospital to report antimicrobial stewardship program activities to each appropriate hospital committee undertaking clinical quality improvement activities. Assembly Amendments (1) change the subject of the bill; (2) make technical changes related to the membership of the antimicrobial stewardship committee; and (3) require the antimicrobial stewardship policy to include a process to evaluate the use of antibiotics, as specified. ANALYSIS : Existing law: 1.Provides for the licensure and inspection of health facilities, including general acute care hospitals, by the Department of Public Health (DPH). 2.Requires general acute care hospitals to develop a process for evaluating the judicious use of antibiotics, the result of which is required to be monitored by appropriate representatives and committees involved in quality improvement activities. This bill requires each general acute care hospital, as defined, to do all of the following by July 1, 2015: 1. Adopt and implement an antimicrobial stewardship policy in accordance with guidelines established by the federal government and professional organizations. Requires this policy to include a process to evaluate the judicious use of antibiotics, as specified. 2. Develop a physician-supervised multidisciplinary antimicrobial stewardship committee, subcommittee, or workgroup. 3. Appoint to the physician-supervised multidisciplinary CONTINUED SB 1311 Page 3 antimicrobial stewardship committee, subcommittee, or workgroup, at least one physician or pharmacist who is knowledgeable about the subject of antimicrobial stewardship through prior training or attendance at continuing education programs, including programs offered by the federal Centers for Disease Control and Prevention (CDC), the Society for Healthcare Epidemiology of America (SHEA), or similar recognized professional organizations. 4. Report antimicrobial stewardship program activities to each appropriate hospital committee undertaking clinical quality improvement activities. 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 health care settings, such as hospitals and nursing homes. According to a February 2013 joint letter from the Infectious Diseases Society of America and the 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 health care 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 CONTINUED SB 1311 Page 4 crisis that has been building up over decades, so that today common and life-threatening infections are becoming difficult or even 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. 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 health care 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. Prior Legislation 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 responsibilities of DPH's Healthcare Associated Infection (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 CONTINUED SB 1311 Page 5 report positive MRSA and other HAI test results to DPH and requires DPH to make specified information public on its Internet Web site. 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. 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. SB 1487 (Speier of 2004) would have required specified hospitals to have written infection control plans and report to Office of Statewide Health Planning and Development (OSHPD) data, including the rate of HAIs and risk-adjusted infection rate data according to the risk-adjustment methodology determined by CDC. SB 1487 was vetoed by Governor Schwarzenegger, whose veto message suggested that it was unnecessary because of other national efforts, which could call into question the quality and validity of the data without proper auditing, and because it would impose significant costs to hospitals and OSHPD. FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes Local: Yes According to the Assembly Appropriations Committee: One-time costs of approximately $50,000, likely in 2017, to aggregate data collected through enforcement and prepare a report on compliance (Licensing and Certification Fund). Minor and absorbable ongoing costs to DPH to oversee compliance among licensed hospitals (Licensing and Certification Fund). CONTINUED SB 1311 Page 6 SUPPORT : (Verified 8/12/14) California Academy of Preventive Medicine California Hospital Association California Pharmacists Association San Francisco Bay Area Physicians for Social Responsibility Stanford Hospital and Clinics ARGUMENTS IN SUPPORT : The California Hospital Association (CHA) states that improving the use of antibiotics is an important patient safety and public health issue as well as a national priority. CHA states that ASPs can both optimize the treatment of infections and reduce adverse events associated with antibiotic use. San Francisco Bay Area Physicians for Social Responsibility states, one of the most important actions that can be taken to slow the development of antibiotic resistance is to ensure that antibiotics are used judiciously through the establishment of ASP. ASPs represent a commitment to always use antibiotics only when they are necessary; to choose the right antibiotics; and to administer them in the right way. ASSEMBLY FLOOR : 78-0, 8/11/14 AYES: Achadjian, Alejo, Allen, Ammiano, Bigelow, Bloom, Bocanegra, Bonilla, Bonta, Bradford, Brown, Buchanan, Ian Calderon, Campos, Chau, Chávez, Chesbro, Conway, Cooley, Dababneh, Dahle, Daly, Dickinson, Eggman, Fong, Fox, Frazier, Beth Gaines, Garcia, Gatto, Gomez, Gonzalez, Gordon, Gorell, Gray, Grove, Hagman, Hall, Harkey, Roger Hernández, Holden, Jones, Jones-Sawyer, Levine, Linder, Logue, Lowenthal, Maienschein, Mansoor, Medina, Melendez, Mullin, Muratsuchi, Nazarian, Nestande, Olsen, Pan, Patterson, Perea, John A. Pérez, V. Manuel Pérez, Quirk, Quirk-Silva, Rendon, Ridley-Thomas, Rodriguez, Salas, Skinner, Stone, Ting, Wagner, Waldron, Weber, Wieckowski, Wilk, Williams, Yamada, Atkins NO VOTE RECORDED: Donnelly, Vacancy JL:de 8/12/14 Senate Floor Analyses SUPPORT/OPPOSITION: SEE ABOVE **** END **** CONTINUED SB 1311 Page 7 CONTINUED