Under the Veterinary Medicine Practice Act, the Veterinary Medical Board licenses veterinarians and regulates the practice of veterinary medicine. The act requires an applicant for a renewal license to complete 36 hours of continuing education in the preceding 2 years.

This bill would require a veterinarian who renews his or her license on or after January 1, 2018, to complete a minimum of one credit hour of continuing education on the judicious use of medically important antimicrobial drugs, as defined, every 4 years as part of the continuing education requirement.

Existing law provides for the licensure and regulation of skilled nursing facilities by the State Department of Public Health. Under existing law, a violation of the provisions governing skilled nursing facilities constitutes a crime. Existing law also establishes the Hospital Infectious Disease Control Program, which requires the department and general acute care hospitals to implement various measures relating to the prevention of health care associated infection. The program requires, by July 1, 2015, that each general acute care hospital adopt and implement an antimicrobial stewardship policy, in accordance with guidelines established by the federal government and professional organizations, that includes a process to evaluate the judicious use of antibiotics, as specified.

This bill would require all skilled nursing facilities, as defined, by no later than January 1, 2017, to adopt and implement an antimicrobial stewardship policy that is consistent with the antimicrobial stewardship guidelines developed by the federal Centers for Disease Control and Prevention, the federal Centers for Medicare and Medicaid Services, or specified professional organizations.

By expanding the scope of an existing crime, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

This bill would declare that it is to take effect immediately as an urgency statute.

Under the Veterinary Medicine Practice Act, the Veterinary Medical Board licenses veterinarians and regulates the practice of veterinary medicine. The act requires an applicant for a renewal license to complete 36 hours of continuing education in the preceding 2 years.

This bill would require a veterinarian who renews his or her license on or after January 1, 2018, to complete a minimum of one credit hour of continuing education on the judicious use of medically important antimicrobial drugs, as defined, every 4 years as part of the continuing education requirement.

Existing law provides for the licensure and regulation of skilled nursing facilities by the State Department of Public Health. Under existing law, a violation of the provisions governing skilled nursing facilities constitutes a crime. Existing law also establishes the Hospital Infectious Disease Control Program, which requires the department and general acute care hospitals to implement various measures relating to the prevention of health care associated infection. The program requires, by July 1, 2015, that each general acute care hospital adopt and implement an antimicrobial stewardship policy, in accordance with guidelines established by the federal government and professional organizations, that includes a process to evaluate the judicious use of antibiotics, as specified.

This bill would require all skilled nursing facilities, as defined, by no later than January 1, 2017, to adopt and implement an antimicrobial stewardship policy that is consistent with the antimicrobial stewardship guidelines developed by the federal Centers for Disease Control and Prevention, the federal Centers for Medicare and Medicaid Services, or specified professional organizations.

By expanding the scope of an existing crime, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

This bill would declare that it is to take effect immediately as an urgency statute.

Under the Veterinary Medical Practice Act, the Veterinary Medical Board licenses veterinarians and regulates the practice of veterinary medicine. The act requires an applicant for a renewal license to complete 36 hours of continuing education in the preceding 2 years.

This bill would require a veterinarian who renews his or her license on or after January 1, 2018, to complete a minimum of one credit hour of continuing education on the judicious use of medically important antimicrobial drugs, as defined, every 4 years as part of the continuing education requirement.

Existing law provides for the licensure and regulation of skilled nursing facilities by the State Department of Public Health. Under existing law, a violation of the provisions governing skilled nursing facilities constitutes a crime. Existing law also establishes the Hospital Infectious Disease Control Program, which requires the department and general acute care hospitals to implement various measures relating to the prevention of health care associated infection. The program requires, by July 1, 2015, that each general acute care hospital adopt and implement an antimicrobial stewardship policy, in accordance with guidelines established by the federal government and professional organizations, that includes a process to evaluate the judicious use of antibiotics, as specified.

This bill would require all skilled nursing facilities, as defined, by no later than January 1, 2017, to adopt and implement an antimicrobial stewardship policy. The bill would also require each skilled nursing facility, within 3 months of the establishment of antimicrobial stewardship guidelines by policy that is consistent with the antimicrobial stewardship guidelines developed by the federal Centers for Disease Control and Prevention, the federal Centers for Medicare and Medicaid Services, or specified professional organizations, to amend its policy to be consistent with those antimicrobial stewardship guidelines. organizations.

By expanding the scope of an existing crime, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

This bill would declare that it is to take effect immediately as an urgency statute.

Under the Veterinary Medical Practice Act, the Veterinary Medical Board licenses veterinarians and regulates the practice of veterinary medicine. The act requires an applicant for a renewal license to complete 36 hours of continuing education in the preceding 2 years.

This bill would require a veterinarian who renews his or her license on or after January 1, 2018, to complete a minimum of one unit credit hour of continuing education on the judicious use of medically important antimicrobial drugs, as defined, every 4 years as part of the continuing education requirement.

Existing law provides for the licensure and regulation of skilled nursing facilities by the State Department of Public Health. Under existing law, a violation of the provisions governing skilled nursing facilities constitutes a crime. Existing law also establishes the Hospital Infectious Disease Control Program, which requires the department and general acute care hospitals to implement various measures relating to the prevention of health care associated infection. The program requires, by July 1, 2015, that each general acute care hospital adopt and implement an antimicrobial stewardship policy, in accordance with guidelines established by the federal government and professional organizations, that includes a process to evaluate the judicious use of antibiotics, as specified.

This bill would require all skilled nursing facilities, as defined, by no later than January 1, 2017, to adopt and implement an antimicrobial stewardship policy. The bill would also require each skilled nursing facility, within 3 months of the establishment of antimicrobial stewardship guidelines by the federal Centers for Disease Control and Prevention Prevention, the federal Centers for Medicare and Medicaid Services, or specified professional organizations, to amend its policy to be consistent with those antimicrobial stewardship guidelines.

By expanding the scope of an existing crime, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

This bill would declare that it is to take effect immediately as an urgency statute.

Under the Veterinary Medical Practice Act, the Veterinary Medical Board licenses veterinarians and regulates the practice of veterinary medicine. The act requires an applicant for a renewal license to complete 36 hours of continuing education in the preceding 2 years.

This bill would require a veterinarian who receives renews his or her license on or after January 1, 2018, to complete an approved course a minimum of one unit of continuing education on the judicious use of medically important antimicrobial drugs, as defined, every 4 years as part of the continuing education requirement.

Existing law provides for the licensure and regulation of skilled nursing facilities by the State Department of Public Health. Under existing law, a violation of the provisions governing skilled nursing facilities constitutes a crime. Existing law also establishes the Hospital Infectious Disease Control Program, which requires the department and general acute care hospitals to implement various measures relating to the prevention of health care associated infection. The program requires, by July 1, 2015, that each general acute care hospital adopt and implement an antimicrobial stewardship policy, in accordance with guidelines established by the federal government and professional organizations, that includes a process to evaluate the judicious use of antibiotics, as specified.

This bill would require all skilled nursing facilities, as defined, by no later than January 1, 2017, to adopt and implement an antimicrobial stewardship policy. The bill would also require each skilled nursing facility, within 3 months of the establishment of antimicrobial stewardship guidelines by the federal Centers for Disease Control and Prevention or specified professional organizations, to amend its policy to be consistent with those antimicrobial stewardship guidelines.

By expanding the scope of an existing crime, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

This bill would declare that it is to take effect immediately as an urgency statute.

Existing law provides for the licensure and regulation of skilled nursing facilities by the State Department of Public Health. Under existing law, a violation of the provisions governing skilled nursing facilities constitutes a crime. Existing law also establishes the Hospital Infectious Disease Control Program, which requires the department and general acute care hospitals to implement various measures relating to the prevention of health care associated infection. The program requires, by July 1, 2015, that each general acute care hospital adopt and implement an antimicrobial stewardship policy, in accordance with guidelines established by the federal government and professional organizations, that includes a process to evaluate the judicious use of antibiotics, as specified.

This bill would require all skilled nursing facilities, as defined, by no later than January 1, 2017, to adopt and implement an antimicrobial stewardship policy. The bill would also require each skilled nursing facility, within 3 months of the establishment of antimicrobial stewardship guidelines by the federal Centers for Disease Control and Prevention or specified professional organizations, to amend its policy to be consistent with those antimicrobial stewardship guidelines.

By expanding the scope of an existing crime, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

This bill would declare that it is to take effect immediately as an urgency statute.

Existing law provides for the licensure and regulation of skilled nursing facilities by the State Department of Public Health. Under existing law, a violation of the provisions governing skilled nursing facilities constitutes a crime. Existing law also establishes the Hospital Infectious Disease Control Program, which requires the department and general acute care hospitals to implement various measures relating to the prevention of health care associated infection. The program requires, by July 1, 2015, that each general acute care hospital adopt and implement an antimicrobial stewardship policy, in accordance with guidelines established by the federal government and professional organizations, that includes a process to evaluate the judicious use of antibiotics, as specified.

This bill would require the department, all skilled nursing facilities, as defined, by no later than July 1, 2016, to develop guidelines in accordance with guidelines established by the federal government and professional organizations, extending the principles of antimicrobial stewardship in order to promote the judicious use of antimicrobials in all skilled nursing facilities, as defined. January 1, 2017, to adopt and implement an antimicrobial stewardship policy. The bill would also require each skilled nursing facility, within 3 months of the establishment of antimicrobial stewardship guidelines by the federal Centers for Disease Control and Prevention or professional organizations, to amend its policy to be consistent with those antimicrobial stewardship guidelines.

By expanding the scope of an existing crime, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

This bill would declare that it is to take effect immediately as an urgency statute.

Existing law provides for the licensure and regulation of skilled nursing facilities by the State Department of Public Health. Under existing law, a violation of the provisions governing skilled nursing facilities constitutes a crime. Existing law also establishes the Hospital Infectious Disease Control Program, which requires the department and general acute care hospitals to implement various measures relating to the prevention of health care associated infection. The program requires, by July 1, 2015, that each general acute care hospital adopt and implement an antimicrobial stewardship policy, in accordance with guidelines established by the federal government and professional organizations, that includes a process to evaluate the judicious use of antibiotics, as specified.

This bill would require the department, by no later than July 1, 2016, to develop guidelines in accordance with guidelines established by the federal government and professional organizations, extending the principles of antimicrobial stewardship in order to promote the judicious use of antimicrobials in all skilled nursing facilities, as defined.

By expanding the scope of an existing crime, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

This bill would declare that it is to take effect immediately as an urgency statute.

 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 APPROPRIATIONS COMMITTEE: Senate Rule 28.8

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, 2017.

Assembly Amendments require a licensed veterinarian to complete 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 facilities.

ANALYSIS:

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 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 requirements.

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

Comments

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 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 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:

1. 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;

2. 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;

3. 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 attributes;  

4. Developing recommendations with the Antimicrobial Stewardship Subcommittee of the California HAI Advisory Committee;

5. Defining activities that comprise ASPs in California hospitals; and,

6. 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 specified.

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 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 website.

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.: Yes Local: 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 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: (Verified 8/31/15)

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

CalPIRG

Health Officers Association of California

OPPOSITION: (Verified 8/31/15)

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 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

**** END ****

SENATE THIRD READING

STR Bill Id:SB 361

Author:(Hill)

As Amended Ver:August 27, 2015

2/3 vote. Urgency

SENATE VOTE: 35-0

SUMMARY: 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 use of medically important antimicrobial drugs every four years. Requires skilled nursing facilities (SNFs) to adopt and implement an antimicrobial stewardship policy (ASP), by January 1, 2017, that is consistent with new guidelines established by the federal Centers for Disease Control and Prevention (CDC) or other professional organizations. Contains an urgency clause to ensure that the provisions of this bill go into immediate effect upon enactment.

FISCAL EFFECT: According to the Assembly Appropriations Committee, this bill would have minor and absorbable costs to the Licensing and Certification (L&C) division of the Department of Public Health (DPH) to verify SNF compliance with the new ASP requirement during the course of routine inspections or on a complaint basis (L&C Fund). In addition, this bill would have minor and absorbable costs to the Veterinary Medical Board (VMB) to approve required courses and verify compliance with the new continuing education requirement (VMB Fund). Finally, the Assembly Appropriations Committee states there would be potential unknown, likely minor information technology costs to both departments for system modifications to capture the new requirements (L&C Fund /VMB Contingent Fund).

COMMENTS: According to the author, the overuse and misuse of antibiotics in nursing homes can lead to the development of antibiotic resistant infections, which is a national and worldwide public health threat. The author points to reports by the CDC which state that at least two million Americans are infected with antibiotic resistant infections annually, and are the cause of death to approximately 23,000 people each year. These reports also maintain that up to 50% of all antibiotics prescribed for patients are unnecessary or are not optimally effective as prescribed. The author contends that 70% of nursing home residents throughout the nation receive an antibiotic each year, and that 27,000 residents acquire antibiotic resistant infections, referring to research which suggests that 25 to 75% of antibiotic use in long-term care settings may be inappropriate and may contribute to the prevalence of antibiotic resistance. The author concludes that ASPs are an effective way to promote judicious antibiotic use and reduce antibiotic resistance, and that this bill is necessary to alleviate a deficiency in existing law by extending these programs to SNFs.

California is the first, and remains the only state, to enact an antimicrobial stewardship program. DPH states the major objectives of antimicrobial stewardship are to optimize clinical outcomes for patients while minimizing toxicity and other adverse events associated with antimicrobial use. Since 2008, California has required general acute care hospitals to develop a process for monitoring the judicious use of antibiotics, and has mandated that the results are monitored by quality improvement committees. Studies have shown that ASPs are particularly active in community settings. DPH currently offers an ASP toolkit to the public, to provide hospital leadership and support staff with guidelines, resources, and practical examples of how best to implement ASP practices.

Existing California law requires the Veterinary Medical Board to only renew licenses to practicing veterinarians who have completed a minimum of 36 hours of continuing education in the previous two years. Current statute does not explicitly require any hours of continuing education to be on the subject of the use of antimicrobial drugs.

The Health Officers Association of California supported a previous version of this bill stating it is imperative for SNFs to adopt policies that reduce the consequences of antibiotic resistance because residents are often elderly or disabled patients with underlying health conditions that make them more vulnerable to contracting disease. Blue Shield of California also supported a previous version of this bill, contending that it has been well documented by the CDC that antibiotics are grossly overused in nursing homes and can lead to the development of antibiotic resistant infections. Blue Shield of California also stated antibiotic resistant infections add considerable and avoidable costs to the already overburdened healthcare system, as these infections require prolonged and costlier treatments. The California Optometric Association and CALPIRG supported a previous version of this bill, stating that each year at least two million Americans are infected with – and at least 23,000 Americans die from – antibiotic resistant infections. The California Long-Term Care Ombudsman Association also supported a previous version of this bill, asserting that the current practice of giving SNF residents antimicrobial medications prior to confirmation or test results recommending such medications puts residents at risk.

There is no known opposition to this bill.

Analysis Prepared by: An-Chi Tsou / HEALTH / (916) 319-2097 FN: 0001592

SENATE THIRD READING

STR Bill Id:SB 361

Author:(Hill)

As Amended Ver:August 17, 2015

2/3 vote. Urgency

SENATE VOTE: 35-0

SUMMARY: 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 use of medically important antimicrobial drugs every four years. Requires skilled nursing facilities (SNFs) to adopt and implement an antimicrobial stewardship policy (ASP) by January 1, 2017, as specified. Requires SNFs to update their ASPs to be consistent with new guidelines established by the federal Centers for Disease Control and Prevention (CDC) or other professional organizations within three months of the publication of such new guidelines. Contains an urgency clause to ensure that the provisions of this bill go into immediate effect upon enactment.

FISCAL EFFECT: According to the Assembly Appropriations Committee, this bill would have minor and absorbable costs to the Licensing and Certification (L&C) division of the Department of Public Health (DPH) to verify SNF compliance with the new ASP requirement during the course of routine inspections or on a complaint basis (L&C Fund). In addition, this bill would have minor and absorbable costs to the Veterinary Medical Board (VMB) to approve required courses and verify compliance with the new continuing education requirement (VMB Fund). Finally, the Assembly Appropriations Committee states there would be potential unknown, likely minor information technology costs to both departments for system modifications to capture the new requirements (L&C Fund /VMB Contingent Fund).

COMMENTS: According to the author, the overuse and misuse of antibiotics in nursing homes can lead to the development of antibiotic resistant infections, which is a national and worldwide public health threat. The author points to reports by the CDC which state that at least two million Americans are infected with antibiotic resistant infections annually, and are the cause of death to approximately 23,000 people each year. These reports also maintain that up to 50% of all antibiotics prescribed for patients are unnecessary or are not optimally effective as prescribed. The author contends that 70% of nursing home residents throughout the nation receive an antibiotic each year, and that 27,000 residents acquire antibiotic resistant infections, referring to research which suggests that 25% to 75% of antibiotic use in long-term care settings may be inappropriate and may contribute to the prevalence of antibiotic resistance. The author concludes that ASPs are an effective way to promote judicious antibiotic use and reduce antibiotic resistance, and that this bill is necessary to alleviate a deficiency in existing law by extending these programs to SNFs.

California is the first, and remains the only state, to enact an antimicrobial stewardship program. DPH states the major objectives of antimicrobial stewardship are to optimize clinical outcomes for patients while minimizing toxicity and other adverse events associated with antimicrobial use. Since 2008, California has required general acute care hospitals to develop a process for monitoring the judicious use of antibiotics, and has mandated that the results are monitored by quality improvement committees. Studies have shown that ASPs are particularly active in community settings. DPH currently offers an ASP toolkit to the public, to provide hospital leadership and support staff with guidelines, resources, and practical examples of how best to implement ASP practices.

Existing California law requires the Veterinary Medical Board to only renew licenses to practicing veterinarians who have completed a minimum of 36 hours of continuing education in the previous two years. Current statute does not explicitly require any hours of continuing education to be on the subject of the use of antimicrobial drugs.

The Health Officers Association of California supported a previous version of this bill stating it is imperative for SNFs to adopt policies that reduce the consequences of antibiotic resistance because residents are often elderly or disabled patients with underlying health conditions that make them more vulnerable to contracting disease. Blue Shield of California also supported a previous version of this bill, contending that it has been well documented by the CDC that antibiotics are grossly overused in nursing homes and can lead to the development of antibiotic resistant infections. Blue Shield also stated antibiotic resistant infections add considerable and avoidable costs to the already overburdened healthcare system, as these infections require prolonged and costlier treatments. The California Optometric Association and CALPIRG supported a previous version of this bill, stating that each year at least two million Americans are infected with – and at least 23,000 Americans die from – antibiotic resistant infections. The California Long-Term Care Ombudsman Association also supported a previous version of this bill, asserting that the current practice of giving SNF residents antimicrobial medications prior to confirmation or test results recommending such medications puts residents at risk.

There is no known opposition to this bill.

Analysis Prepared by: An-Chi Tsou / HEALTH / (916) 319-2097 FN: 0001534

Date of Hearing: August 19, 2015

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Jimmy Gomez, Chair

SBPCA Bill Id:SB 361

Author:(Hill) – As Amended Ver:August 17, 2015

Urgency: Yes State Mandated Local Program: Yes Reimbursable: No

SUMMARY:

This bill, an urgency measure, contains two requirements intended to combat antimicrobial resistance. Specifically, this bill:

1. Requires skilled nursing facilities (SNFs) to, by January 2017, adopt and implement antimicrobial stewardship policies; requires compliance with related federal guidelines, and allows for state citations for non-compliance.

2. Requires a veterinarian who receives a license after January 1, 2018 to complete an approved course on the judicious use of antibiotics every four years as part of existing continuing education (CE) requirements.

FISCAL EFFECT:

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 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).

COMMENTS:

1. Purpose. The author indicates the overuse and misuse of antibiotics in medicine is a significant factor driving the development of antibiotic resistance, a growing public health threat. This bill intends to ensure best practices in the use of human and animal antibiotic administration to encourage judicious use.

2. Antimicrobial Stewardship. Antibiotics are credited with significantly reducing morbidity and mortality associated with bacterial infections. Unfortunately, widespread use of antibiotics has led to antibiotic resistance, which, according to the World Health Organization (WHO), is an increasingly serious threat to global public health. The WHO indicates evolution of drug-resistant strains is a natural phenomenon, but the use and misuse of antibiotics accelerates their emergence. Drug-resistant infections are often difficult to treat and can be deadly. The Centers for Disease Control and Prevention (CDC) indicates at least 2 million people become infected with resistant bacteria nationwide, and at least 23,000 people die as a direct result of these infections, each year. Antibiotic stewardship programs are designed to promote and measure the appropriate use of antibiotics in a facility, and are recommended by WHO, CDC, and DPH. DPH provides technical assistance to hospitals and other facilities to implement local antimicrobial stewardship programs as part of their Healthcare Acquired Infections program, and collects data on these programs that are submitted on a voluntary basis.

3. Current Related Legislation. SB 27 (Hill) restrict the use of medically important antimicrobial drugs in livestock, require a veterinarian’s prescription or feed directive for use, eliminate the over-the-counter availability of these drugs, require the California Department of Food and Agriculture (CDFA) to develop a program to track antimicrobial drug use in livestock and the emergence of antimicrobial-resistant bacteria, and require CDFA to adopt judicious use and antimicrobial stewardship guidelines.

4. Prior Related Legislation. SB 1311 (Hill), Chapter 843, Statutes of 2014, requires all general acute-care hospitals to adopt and implement an antimicrobial stewardship policy that includes a process to evaluate the judicious use of antibiotics.

Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081

Date of Hearing: July 14, 2015

ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS

Susan Bonilla, Chair

SBPCA Bill Id:SB 361

Author:(Hill) – As Amended Ver:July 2, 2015

NOTE: The prior version of this bill was heard by the Assembly Committee on Health on June 23, 2015, and approved on a 19-0 vote.

NOTE: This bill adds an urgency clause.

SENATE VOTE: 35-0

SUBJECT: Antimicrobial stewardship: education and policies.

SUMMARY: Requires a veterinarian who receives his or her license on or after January 1, 2018, to take a course on antimicrobial stewardship as part of continuing education (CE), and requires skilled nursing facilities to adopt and implement antimicrobial stewardship policies, as specified, on or before January 1, 2017.

EXISTING LAW:

1. Requires each individual licensed by the Veterinary Medical Board (VMB) to apply biennially to renew their license or registration on or before the last day of the applicant's birthday month. (Business and Professions Code (BPC) Section 4846.4(a))

2. Requires the VMB to provide license renewals to those applicants who have completed a minimum of 36 hours of CE in the preceding two years, as specified. (BPC Section 4846.5(a))

3. Permits licensees to obtain CE credit by attending courses relevant to veterinary medicine and sponsored or cosponsored by specified entities. (BPC Section 4846.5(b))

4. Authorizes the VMB to audit the records of all applicants to verify the completion of the CE requirement, and requires applicants to maintain records of completion of required CE coursework for a period of four years, and to make the records available to the VMB for auditing purposes. (BPC Section 4846.5(e))

5. Permits the VMB, in its discretion, to exempt from the CE requirement any veterinarian who, for reasons of health, military service, or undue hardship, cannot meet the CE requirements. (BPC 4846.5(h))

6. Defines a “skilled nursing facility” as a health facility that provides skilled nursing care and supportive care to patients whose primary need is for availability of skilled nursing care on an extended basis, and includes a “small house skilled nursing facility, as specified. (Health and Safety Code (HSC) Section 1250(c))

7. Requires each general acute care hospital to adopt and implement an antimicrobial stewardship policy in accordance with guidelines established by the federal government and professions and organizations, as specified. (HSC Section 1288.85)

THIS BILL:

1. Requires a veterinarian who receives his or her license, on or after January 1, 2018, to complete an approved course of the judicious use of medically important antimicrobial drugs every four years as part of his or her continuing education requirements.

2. Defines, for the purpose of number 1) above, "medically important antimicrobial drug" to mean an antimicrobial drug listed in appendix A of the federal Food and Drug Administration's (FDA) Guidance for Industry #152, including critically important, highly important, and important antimicrobial drugs as that appendix may be amended.

3. Requires, on or before January 1, 2017, each skilled nursing facility, as specified, to adopt and implement an antimicrobial stewardship policy.

4. Requires each skilled nursing facility, within three months of the establishment of antimicrobial stewardship guidelines specific to skilled nursing facilities by the federal Centers for Disease Control and Prevention (CDC), the Society for Healthcare Epidemiology of America, or similar recognized professional organizations, to amend its antimicrobial stewardship policy to be consistent with those newly established antimicrobial stewardship guidelines.

5. Specifies enforcement actions for skilled nursing facilities which fail to comply with establishing antimicrobial stewardship guidelines.

6. Provides that no reimbursement is required by this bill pursuant to Section 6 of Article XIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction.

7. Declares that this bill take effect immediately to protect Californians from the burden and threats posed by the national security priority of antimicrobial-resistant infections.

FISCAL EFFECT: According to the Senate Appropriations Committee, pursuant to Senate Rule 28.8, the prior version of this bill would result in negligible state costs. The amended version of this bill has not been analyzed by a fiscal committee.

COMMENTS:

Purpose. According to the author, "The overuse and misuse of antibiotics can lead to the development of antibiotic resistant infections, a major national and worldwide public health concern. The [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 significant factor driving the development of antibiotic resistance. Nationwide, up to 70% of nursing home residents receive an antibiotic every year and 27,000 acquire antibiotic resistant infections, such as Staphylococcus aureus (MRSA). Studies suggest that between 25%-75% of antibiotic use in long-term care settings may be inappropriate, contributing to the prevalence of antibiotic resistance.

As veterinarians continue to gain more authority in the administration of these lifesaving drugs, it’s important that veterinarians keep up to date on the most relevant and recent research as it relates to using antibiotics in the most effective manner possible. While antibiotic stewardship programs are used in human medical facilities to promote judicious prescribing, veterinarians often work in small clinics or out in the field and the best way to promote the judicious use of antibiotics by veterinarians is to require continuing education in the subject. To ensure that veterinarians prescribe antibiotics in a judicious manner, [this bill] requires veterinarians to take continuing education units on the judicious use of antibiotics every four years."

Background. In addition to requiring skilled nursing facilities to adopt and implement an antimicrobial stewardship policy, this bill was recently amended to add a new provision which would require veterinarians who renew their license to take an approved CE course with instruction about the judicious use of antibiotics every four years in order to renew their license. The CE can be completed by taking courses sponsored by various organizations, such as the American Veterinary Medical Association, or accredited veterinary medical colleges. The author notes that 70% of all antibiotics sold across the country are sold to be used to treat livestock and animals and is a factor driving the development of antibiotic resistant infections.

Veterinarians and the Veterinarian Medical Board (VMB). The VMB is the regulatory entity responsible for the licensure and regulation of veterinarians, registered veterinary technicians (RVT), schools and programs along with veterinary premises and hospitals through the enforcement of the California Veterinary Medicine Practice Act. The VMB develops and enforces the standards for examinations, licensing, and hospital and school inspections. The VMB licenses over 10,000 Veterinarians and 5,000 RVTs. The veterinary medical profession provides health care to a variety of animals including livestock, poultry, and pets including birds, fish, rabbits, hamsters, snakes, dogs, cats, goats, pigs, horses, and llamas.

In order to be licensed as a veterinarian in California, an individual must possess a degree in veterinary medicine from an accredited school, and take and pass a national veterinary licensing examination and a California-based examination administered by the VMB. In order to renew a license, an individual is required to complete 36 hours of CE every two-years; however, current law does not designate the subject of the course or courses a licensee must complete. This bill would require a licensed veterinarian to complete an approved course on the judicious use of antimicrobial drugs every four-years in order to renew their license, but does not specify a minimum or maximum amount of CE hours that can be completed in this area. As currently drafted, this bill would permit a licensee to take all 36 CE hours in the judicial use of antimicrobial drugs or complete just a fraction of those hours. As the author notes, it is important that veterinarians keep up-to-date on the most relevant and recent research as it relates to using antibiotics in the most effective way possible. By requiring a veterinarian to take CE courses on this topic, it will help provide veterinarians with relevant information.

Antimicrobial Issues. According to the CDC, antibiotics have transformed medicine making once lethal infections readily treatable; however, 20-50 percent of all antibiotics prescribed in the United States’ acute care hospitals are either unnecessary or inappropriate. The misuse of antibiotics has contributed to the growing problem of antibiotic resistance, and the CDC notes that more than 2 million people are sickened every year with antibiotic-resistant infections with at least 23,000 resulting in death. As noted in the United Stated Department of Agriculture's (USDA) Action Plan to Address Antimicrobial Resistance, the USDA notes that the health of humans and animals is irrevocable linked and closely connected to the environment.

The California Antimicrobial Stewardship Program and Federal Guidance. The California Department of Public Health (DPH) administers an antimicrobial stewardship program. According to the DPH, California is the first and only state to enact such a program.

Nationally, a presidential Executive Order - Combatting Antibiotic-Resistant Bacteria, issued in September 2014, requires federal agencies to review existing regulations and propose new regulations or other actions to require hospitals to implement robust stewardship programs that adhere to best practices; agencies will also be required to define, promulgate and implement stewardship programs in other settings such as long-term care facilities and outpatient settings. This bill requires skilled nursing facilities to implement an antimicrobial stewardship policy on or before January 1, 2017 which is already required for each general acute care hospital in California.

The CDC reports that "antibiotics must be used judiciously in humans and animals because both uses contribute to the emergence, persistence, and spread of resistant bacteria. Resistant bacteria in food-producing animals are of particular concern. Food animals serve as a reservoir of resistant pathogens and resistance mechanisms that can directly or indirectly result in antibiotic resistant infections in humans. For example, resistant bacteria may be transmitted to humans through the foods we eat."

As a result, the FDA, in conjunction with the CDC and the USDA, established the National Antimicrobial Resistance Monitoring System which monitors trends in antimicrobial resistance from human, retail meat, and food animal samples. The goals and objectives of the system are to monitor trends among foodborne bacteria, conduct research to better understand the emergence and spread of bacterial, and to assist the FDA in the decision-making process for the approval of antimicrobial drugs for animals.

To ensure veterinarians stay current on these issues, this bill requires licensees to complete a course on the judicious use of antimicrobial drugs as part of their CE requirements.

Current Related Legislation. The portion of this bill that requires veterinarians to take CE courses every four years, in the judicious use of antimicrobial drugs, in order to renew his or her license, is complimentary to SB 27 (Hill) of the current legislative session. This bill aims to change the way in which medically important antimicrobial drugs are utilized in livestock. SB 27 proposes to restrict the use of medically important antimicrobial drugs in livestock, require a veterinarian’s prescription or feed directive for use, eliminate the over-the-counter availability of these drugs, require the California Department of Food and Agriculture (CDFA) to develop a program to track antimicrobial drug use in livestock and the emergence of antimicrobial-resistant bacteria, and require CDFA to adopt judicious use and antimicrobial stewardship guidelines. As SB 27 proposes to reshape the landscape with respect to veterinarian's issuance of antibiotics, this bill aims to provide a useful tool to educate veterinarians on the issues surrounding antimicrobial drugs. NOTE: This bill is currently pending in the Assembly Appropriations Committee.

Prior Related Legislation. SB 1311 (Hill), Chapter 843, Statutes of 2014, requires all general acute-care hospitals to adopt and implement an antimicrobial stewardship policy that includes a process to evaluate the judicious use of antibiotics.

POLICY ISSUES AND AMENDMENT:

As drafted, it is unclear if this bill would apply to current licensees or only to those individuals who become licensed after January 1, 2018. The author notes that this bill should apply to all licensees who are subject to CE requirements for licensure renewal. Also, this bill does not specify the number of CE units a licensee may obtain in the judicious use of antimicrobial drugs in order to provide discretion to those licensees who may wish to take multiple CE courses on this topic; however, as drafted, this bill does not clearly provide for that flexibility.

In order to make it explicitly clear that this bill applies to all licensees, including both existing and new, and that a veterinarian must obtain a minimum of 1 CE unit on the judicious use of antimicrobial drugs, the author may wish to accept the following amendment:

Replace the current proposed BPC Section 4846.5 (k)(1) with the following:

On or after January 1, 2018, a licensed veterinarian who renews his or her license shall complete a minimum of one unit of continuing education on the judicious use of medically important antimicrobial drugs every four years as part of his or her continuing education requirements.

REGISTERED SUPPORT:

California Veterinary Medical Association

CALPIRG (3/26/15 version)

Blue Shield of California (3/26/15 version)

California Long-Term Care Ombudsman Association (3/26/15 version)

California Optometric Association (3/26/15 version)

REGISTERED OPPOSITION:

None on file.

Analysis Prepared by: Elissa Silva / B. & P. / (916) 319-3301

Date of Hearing: June 23, 2015

ASSEMBLY COMMITTEE ON HEALTH

Rob Bonta, Chair

SBPCA Bill Id:SB 361

Author:(Hill) – As Amended Ver:April 14, 2015

SENATE VOTE: 35-0

SUBJECT: Skilled nursing facilities: antimicrobial stewardship guidelines.

SUMMARY: Requires skilled nursing facilities (SNFs) to adopt and implement an antimicrobial stewardship policy (ASP) by January 1, 2017, as specified. Requires SNFs to update their ASPs to be consistent with new guidelines established by the federal Centers for Disease Control and Prevention (CDC) or other professional organizations within three months of the publication of such new guidelines. Contains an urgency clause to ensure that the provisions of this bill go into immediate effect upon enactment.

EXISTING LAW:

1. Defines a SNF as health facility that provides skilled nursing care and supportive care to patients whose primary need is for the availability of long-term skilled nursing care.
   
   

2. Establishes the Hospital Infectious Disease Control Program under the Department of Public Health (DPH) to determine best practices and policies related to the prevention of healthcare associated infections (HAIs).
   
   

3. Requires general acute care hospitals to adopt and implement an ASP, as specified, in accordance with existing state law and guidelines established by the federal government and professional organizations.
   
   

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, the overuse and misuse of antibiotics in nursing homes can lead to the development of antibiotic resistant infections, which is a national and worldwide public health threat. The author points to reports by the CDC which state that at least two million Americans are infected with antibiotic resistant infections annually, and are the cause of death to approximately 23,000 people each year. These reports also maintain that up to 50% of all antibiotics prescribed for patients are unnecessary or are not optimally effective as prescribed. The author contends that 70% of nursing home residents throughout the nation receive an antibiotic each year, and that 27,000 residents acquire antibiotic resistant infections, referring to research which suggests that 25-75% of antibiotic use in long-term care settings may be inappropriate and may contribute to the prevalence of antibiotic resistance. The author concludes that ASPs are an effective way to promote judicious antibiotic use and reduce antibiotic resistance, and that this bill is necessary to alleviate a deficiency in existing law by extending these programs to SNFs.
   
   

2. BACKGROUND.
   
   

   1. Antibiotics. Antimicrobial resistance is resistance of a microorganism to an antimicrobial drug that was originally effective for treatment of infections caused by it. Resistant microorganisms (including bacteria, fungi, viruses, and parasites) are able to withstand attack by antimicrobial drugs, such as antibacterial drugs (e.g. antibiotics), antifungals, antivirals, and antimalarials, so that standard treatments become ineffective and infections persist, increasing the risk of spread to others. The evolution of resistant strains is a natural phenomenon that occurs when microorganisms replicate themselves erroneously or when resistant traits are exchanged between them. The use and misuse of antimicrobial drugs accelerates the emergence of drug-resistant strains. Poor infection control practices, inadequate sanitary conditions, and inappropriate food-handling encourage the further spread of antimicrobial resistance. According to the World Health Organization, new resistance mechanisms currently continue to emerge and spread globally, threatening our ability to treat common infectious diseases, and are resulting in the death and disability of individuals who, prior to the emergence of these new resistance mechanisms, could continue a normal course of life. Without effective anti-infective treatment, many standard medical treatments will fail or turn into very high risk procedures.
      
      

   2. President’s Executive Order. In September 2014, President Barack Obama signed an Executive Order directing federal departments and agencies to implement a national strategy for enhancing domestic and international capacity to manage antibiotics and antibiotic-resistant infections. Among other requirements, the Executive Order specifically requires the Departments of Health and Human Services, Defense, and Veterans Affairs to review existing regulations governing antibiotic stewardship in hospitals and other inpatient health care delivery facilities, and to propose new regulations and other actions to improve antibiotic stewardship programs in accordance with best practices in the country, including those defined by the CDC. The Executive Order also requires federal departments and agencies to lead the country by example by implementing stewardship programs in outpatient settings, emergency departments, and institutional and long-term care facilities such as nursing homes, pharmacies, and correctional facilities.
      
      

   3. The California Antimicrobial Stewardship Program. California is the first, and remains the only state, to enact an antimicrobial stewardship program. DPH states the major objectives of antimicrobial stewardship are to optimize clinical outcomes for patients while minimizing toxicity and other adverse events associated with antimicrobial use. Since 2008, California has required general acute care hospitals to develop a process for monitoring the judicious use of antibiotics, and has mandated that the results are monitored by quality improvement committees. Studies have shown that ASPs are particularly active in community settings. DPH currently offers an ASP toolkit to the public, to provide hospital leadership and support staff with guidelines, resources, and practical examples of how best to implement ASP practices.
      
      

3. SUPPORT. The Health Officers Association of California supports this bill stating it is imperative for SNFs to adopt policies that reduce the consequences of antibiotic resistance because residents are often elderly or disabled patients with underlying health conditions that make them more vulnerable to contracting disease. Blue Shield of California supports, contending that it has been well documented by the CDC that antibiotics are grossly overused in nursing homes and can lead to the development of antibiotic resistant infections. Blue Shield also contends antibiotic resistant infections add considerable and avoidable costs to the already overburdened healthcare system, as these infections require prolonged and costlier treatments. The California Optometric Association and CALPIRG support, stating that each year at least two million Americans are infected with – and at least 23,000 Americans die from – antibiotic resistant infections. The California Long-Term Care Ombudsman Association also supported a previous version of this bill, asserting that the current practice of giving SNF residents antimicrobial medications prior to confirmation or test results recommending such medications puts residents at risk.
   
   

4. PREVIOUS LEGISLATION.
   
   

   1. SB 1311 (Hill), Chapter 843, Statutes of 2014, requires all general acute care hospitals to adopt and implement, by July 1, 2015, an ASP, that includes a process to evaluate the judicious use of antibiotics.
      
      

   2. 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 HAIs, expands the 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.
      
      

   3. 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.
      
      

   4. 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.
      
      

5. POLICY COMMENT. This bill requires SNFs to establish and implement an ASP. Existing law requires each general acute care hospital to establish and implement an ASP; in addition, the hospitals are required to develop a physician-supervised multidisciplinary antimicrobial stewardship committee, subcommittee, or workgroup, and to appoint at least one physician or pharmacist to the committee who is knowledgeable about antimicrobial stewardship through specified training. This bill’s language is currently silent as to how the policy must be implemented within each SNF and does not specifically require SNFs to form an antimicrobial stewardship committee. The author may wish to consider amending this bill’s provisions to be consistent with existing statutory requirements regarding ASPs for general acute care hospitals.
   
   

REGISTERED SUPPORT / OPPOSITION:

Support

Blue Shield of California
California Long-Term Care Ombudsman Association (prior version)
California Optometric Association
CALPIRG (prior version)
Health Officers Association of California

Opposition

None on file.

Analysis Prepared by: An-Chi Tsou / HEALTH / (916) 319-2097

 THIRD READING  

Bill No: SB 361

Author: Hill (D)

Amended: 4/14/15

Vote: 27 - Urgency

SENATE HEALTH COMMITTEE: 9-0, 4/8/15

AYES: Hernandez, Nguyen, Hall, Mitchell, Monning, Nielsen, Pan, Roth, Wolk

SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8

SUBJECT: Skilled nursing facilities: antimicrobial stewardship guidelines

SOURCE: Author

DIGEST: This bill requires skilled nursing facilities to adopt and implement an antimicrobial stewardship policy by January 1, 2017.

ANALYSIS:

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.

This bill:

1. Requires SNFs, by January 1, 2017, to adopt and implement an antimicrobial stewardship policy.

2. Requires SNFs, within three months of the establishment of antimicrobial stewardship guidelines specific to SNFs by the federal Centers for Disease Control and Prevention or by professional organizations, including the Society for Healthcare Epidemiology of America, to amend their antimicrobial stewardship policies to be consistent with those newly established guidelines.

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

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

Comments

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 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 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:

1. 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;

2. 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;

3. 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 attributes;  

4. Developing recommendations with the Antimicrobial Stewardship Subcommittee of the California HAI Advisory Committee;

5. Defining activities that comprise ASPs in California hospitals; and,

6. 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 specified.

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 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 website.

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.

SB 1487 (Speier 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, who’s 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

SUPPORT: (Verified 4/28/15)

Blue Shield of California

California Optometric Association

California Long-Term Care Ombudsman Association

CALPIRG

OPPOSITION: (Verified 4/28/15)

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 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.

Prepared by: Vince Marchand / HEALTH /

4/29/15 16:07:31

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SENATE COMMITTEE ON HEALTH

Senator Ed Hernandez, O.D., Chair

BILL NO: SB 361

SUBJECT: Skilled nursing facilities: antimicrobial stewardship guidelines

SUMMARY:

Requires the Department of Public Health to develop antimicrobial stewardship guidelines for skilled nursing facilities by July 1, 2016.

Existing law:

1. Provides for the licensure and regulation of health facilities by the Department of Public Health (DPH), including skilled nursing facilities, 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.

This bill:

1. Requires DPH, by July 1, 2016, to develop guidelines in accordance with guidelines established by the federal government and professional organizations, extending the principles of antimicrobial stewardship in order to promote the judicious use of antimicrobials in all skilled nursing facilities, as defined.

2. Requires DPH to consult with long-term care organizations, infection prevention experts, and other interested stakeholders in the development of the antimicrobial stewardship guidelines.

3. Requires all skilled nursing facilities to comply with the guidelines extending the principles of antimicrobial stewardship, and specifies that failure to comply with DPH’s guidelines may subject the facility to citation and civil penalty provisions in existing law.

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

FISCAL EFFECT:

This bill has not been analyzed by a fiscal committee.

COMMENTS:

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 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 skilled nursing facilities.

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 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:

1. 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;

2. 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;

3. 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 attributes;  

4. Developing recommendations with the Antimicrobial Stewardship Subcommittee of the California HAI Advisory Committee;

5. Defining activities that comprise ASPs in California hospitals; and,

6. The California Antibiogram Project, which collects information on specific antimicrobial-organism combinations across California general acute care hospitals.

5. Prior legislation. SB 1311 (Hill), Chapter 843, Statutes of 2014, requires 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 specified.

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 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 website.

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.

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, who’s 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.

6. 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 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.

7. Author’s amendments. The author has offered amendments in mock-up form that revise this bill as follows:

1. Delete the requirement that DPH develop guidelines by July 1, 2016, and instead require that skilled nursing facilities adopt and implement an ASP by January 1, 2017.

2. Require the ASP to be based on existing guidelines for other facilities established by the federal government or professional organizations until such time when guidelines specific to skilled nursing facilities are established by the federal government or professional organizations. Within three months of the establishment of guidelines specific to skilled nursing facilities, facilities would be required to amend their ASPs to be consistent with the newly established guidelines.

SUPPORT AND OPPOSITION:

Support: Blue Shield of California

California Long-Term Care Ombudsman Association

CALPIRG

Oppose: None received

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