BILL ANALYSIS Ó SB 1311 Page 1 Date of Hearing: June 10, 2014 ASSEMBLY COMMITTEE ON HEALTH Richard Pan, Chair SB 1311 (Hill) - As Amended: June 4, 2014 SENATE VOTE : 35-0 SUBJECT : Hospitals: antimicrobial stewardship. SUMMARY : Requires all general acute-care hospitals to adopt and implement an antimicrobial stewardship policy (ASP). Specifically, this bill requires general acute care hospitals, by July 1, 2015, to: 1)Adopt and implement an antimicrobial stewardship policy in accordance with guidelines established by the federal government and professional organizations. 2)Develop a physician supervised multidisciplinary antimicrobial stewardship committee, subcommittee, or workgroup. 3)Appoint to the committee, subcommittee, or workgroup, at least one physician or pharmacist who is knowledgeable on the subject of antimicrobial stewardship through prior training, professional experience, or attendance at continuing education programs; including, but not limited to, a continuing education training program 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. 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 SB 1311 Page 2 representatives and committees involved in quality improvement activities. FISCAL EFFECT : According to the Senate Appropriations Committee, pursuant to Senate Rule 28.8, negligible state costs. COMMENTS : 1)PURPOSE OF THIS BILL . According to the author, this bill ensures that California continues to be at the forefront of the fight against antibiotic resistance and 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. The author further states, to promote judicious use, the CDC recommends the establishment of ASPs, which represent a "commitment to always use antibiotics only when they are necessary to treat and in some cases prevent, disease; to choose the right antibiotics; and, to administer them in the right way in every case. The author states that effective stewardship ensures that every patient gets the maximum benefit from the antibiotics, avoids unnecessary harm from allergic reaction and side effects, and helps preserve the life-saving potential of these drugs for the future." Finally, the author notes that the Infectious Diseases Society of America says that although California has "the first legislative mandate of its kind, it does not specify that hospitals must intervene to improve antimicrobial use, that is, to have an antimicrobial stewardship program," and due to this ambiguity, only 50% of hospitals have established an antimicrobial stewardship program and only 22% said they were influenced by current law to develop a stewardship program. 2)BACKGROUND . Antibiotics and similar drugs, together called antimicrobial agents, have been used for the last 70 years to treat patients who have infectious diseases. Since the 1940s, these drugs have greatly reduced illness and death from infectious diseases. Antibiotic use has been beneficial and, when prescribed and taken correctly, their value in patient care is enormous. However, these drugs have been used so widely and for so long that the infectious organisms the antibiotics are designed to kill have adapted to them, making the drugs less effective. People infected with antimicrobial-resistant organisms are more likely to have longer, more expensive hospital stays, and may be more likely SB 1311 Page 3 to die as a result of the infection. 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 impossible to treat." Antimicrobial stewardship refers to a set of interventions that improve the appropriate use of antimicrobial agents, including optimal drug selection, dosing, duration of therapy, and route of administration. The primary objective is to achieve the best clinical outcomes for patients while minimizing toxicity and other adverse events associated with antimicrobial use, thereby limiting selective pressure on bacterial populations that drives the emergence of antimicrobial resistant strains. Antimicrobial stewardship policy implementation has also been shown to reduce costs due to improper antimicrobial use. The DPH Hospital Acquired Infection Program supports an antimicrobial stewardship initiative to provide consultation and education to assist California hospitals and other healthcare facilities to implement these important local programs necessary for strengthening the optimization of antimicrobial utilization. Current DPH activities include developing evidence-based recommendations on how to implement or strengthen ASPs given available resources and facility attributes, developing recommendations on internal and external outcome antimicrobial metrics with a group of experts across California, and defining activities that comprise ASPs in California hospitals. 3)SUPPORT . In support of this bill, California Hospital Association writes that a growing body of evidence demonstrates that hospital-based programs dedicated to improving antibiotic use can both optimize the treatment of infections and reduce adverse events associated with antibiotic use. 4)PREVIOUS LEGISLATION . a) SB 158 (Florez), Chapter 294, Statutes of 2008, establishes an infection surveillance, prevention, and control program within DPH to provide oversight of hospital prevention and reporting of general acute care hospital-associated infections (HAI), expands the SB 1311 Page 4 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. b) SB 1058 (Alquist), Chapter 296, Statutes of 2008, establishes the Medical Facility Infection Control and Prevention Act, which requires hospitals to implement specified procedures for screening, prevention, and reporting specified HAIs. Requires hospitals to report positive Methicillin-resistant Staphylococcus aureus and other HAI test results to DPH and requires DPH to make specified information public on its website. c) SB 739 (Speier), Chapter 526, Statutes of 2006, creates 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, 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. Requires 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. d) 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 then Governor Schwarzenegger, whose veto message said, in part, that it was unnecessary because of other national efforts, which could call into question the quality and validity of the data without proper auditing, SB 1311 Page 5 and because it would impose significant costs to hospitals and OSHPD. REGISTERED SUPPORT / OPPOSITION : Support California Hospital Association Physicians for Social Responsibility Stanford Hospital and Clinics Opposition None on file. Analysis Prepared by : Lara Flynn / HEALTH / (916) 319-2097