BILL ANALYSIS Ó
-----------------------------------------------------------------
|SENATE RULES COMMITTEE | SB 361|
|Office of Senate Floor Analyses | |
|(916) 651-1520 Fax: (916) | |
|327-4478 | |
-----------------------------------------------------------------
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
SB 361
Page 2
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
SB 361
Page 3
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
SB 361
Page 4
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
SB 361
Page 5
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:
SB 361
Page 6
a) The HAI Program has launched a statewide Antimicrobial
Stewardship Program Collaborative, with the goal of
ensuring that all California hospitals have a functional
and robust ASP to promote patient safety and to decrease
antimicrobial resistance. The Collaborative will extend for
one year from January through December 2015;
b) Spotlight on ASP Project, which helps define
antimicrobial stewardship programs and activities, and
spotlights volunteer hospitals that want to highlight and
share with others their ASP progress;
c) Utilization of a statewide assessment of ASPs present in
California healthcare facilities (May 2010 - March 2011) to
develop evidence-based recommendations on how to implement
or strengthen ASPs given available resources and facility
attributes;
d) Developing recommendations with the Antimicrobial
Stewardship Subcommittee of the California HAI Advisory
Committee;
e) Defining activities that comprise ASPs in California
hospitals; and,
f) The California Antibiogram Project, which collects
information on specific antimicrobial-organism combinations
across California general acute care hospitals.
Prior Legislation
SB 1311 (Hill, Chapter 843, Statutes of 2014) required general
acute care hospitals, by July 1, 2015, to adopt and implement an
antimicrobial stewardship policy, as specified; develop a
physician supervised multidisciplinary antimicrobial stewardship
committee, subcommittee, or workgroup; appoint at least one
physician or pharmacist who has attended training specifically
on antimicrobial stewardship to the committee, subcommittee, or
workgroup, as specified; and, report antimicrobial stewardship
program activities to appropriate hospital committees, as
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
SB 361
Page 7
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.:YesLocal: Yes
According to the Assembly Appropriations Committee:
1)Minor and absorbable costs to the Licensing and Certification
division of the California Department of Public Health (CDPH)
to verify SNF compliance with the new antimicrobial
stewardship policy requirement during the course of routine
SB 361
Page 8
inspections or on a complaint basis (Licensing and
Certification Fund).
2)Minor and absorbable costs to the Veterinary Medical Board to
approve required courses and verify compliance with the new CE
requirement (Veterinary Medical Board Fund).
3)Potential unknown, likely minor information technology costs
to both departments for system modifications to capture the
new requirements (Licensing and Certification Fund /Veterinary
Medical Board Contingent Fund).
SUPPORT: (Verified8/31/15)
Blue Shield of California
California Children's Hospital Association
California Long-Term Care Ombudsman Association
California Naturopathic Doctors Association
California Optometric Association
California Society of Health-System Pharmacists
California Veterinary Medical Association
CalPIRG
Health Officers Association of California
OPPOSITION: (Verified8/31/15)
None received
ARGUMENTS IN SUPPORT: This bill is supported by CALPIRG,
which states that 70 percent of nursing home residents
nationwide receive an antibiotic every year, and 27,000
residents acquire antibiotic resistant infections. According to
CALPIRG, studies suggest that between 25 and 75 percent of
SB 361
Page 9
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
SB 361
Page 10
**** END ****