BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 1311
AUTHOR: Hill
AMENDED: April 10, 2014
HEARING DATE: April 24, 2014
CONSULTANT: Moreno
SUBJECT : Public health: antimicrobial stewardship.
SUMMARY : 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.
Existing law:
1.Provides for the licensure and inspection of health
facilities, including general acute care hospitals, by the
Department of Public Health (DPH).
2.Requires general acute care hospitals to develop a process for
evaluating the judicious use of antibiotics, the result of
which is required to be monitored by appropriate
representatives and committees involved in quality improvement
activities.
This bill:
1.Requires general acute care hospitals, by July 1, 2015, to:
a. Adopt and implement an antimicrobial stewardship policy
in accordance with guidelines established by the federal
government and professional organizations;
b. Develop a physician supervised multidisciplinary
antimicrobial stewardship committee, subcommittee, or
workgroup;
c. Appoint to the committee, subcommittee, or workgroup, at
least one physician or pharmacist who has attended training
specifically on antimicrobial stewardship; including, but
not limited to, a continuing education training program
Continued---
SB 1311 | Page 2
offered by the federal Centers for Disease Control and
Prevention (CDC), the Society for Healthcare Epidemiology
of America (SHEA), or similar recognized professional
organizations, or post graduate training with a
concentration in antimicrobial stewardship; and,
d. Report antimicrobial stewardship program activities to
each appropriate hospital committee undertaking clinical
quality improvement activities.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
COMMENTS :
1.Author's statement. According to the author, the CDC
estimates that each year at least two million people are
infected with - and at least 23,000 people 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. The CDC has listed antibiotic resistance as its
top public health threat for 2014. Antimicrobial stewardship
programs (ASPs) are critical tools for reducing antibiotic
resistance, reducing healthcare costs, and improving patient
outcomes. Current law requires that general acute care
hospitals "develop a process for evaluating the judicious use
of antibiotics." But while the law is intended to require
stewardship programs at all hospitals, it doesn't specifically
state so. The Infectious Diseases Society of America (IDSA)
says that although California has "the first legislative
mandate of its kind, it does not specify that hospitals must
intervene to improve antimicrobial use, that is, to have an
antimicrobial stewardship program." Due to this ambiguity,
only 50 percent of hospitals have established an ASP and only
22 percent said they were influenced by current law to develop
a stewardship program.
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
SB 1311 | Page
3
nursing homes. According to a February 2013 joint letter from
IDSA and the SHEA to the National Quality Forum, ample data
exist from both inpatient and outpatient settings
demonstrating that antibiotics are often prescribed
sub-optimally or inappropriately. Antibiotics are misused in a
variety of ways. They are often administered when they are not
needed, continued when they are no longer necessary, or
prescribed at the wrong dose. Broad-spectrum agents may be
used unnecessarily against bacteria that are very susceptible
or the wrong antibiotic may be given to treat a particular
infection. Over the past 30 years, bacteria that are
extremely resistant to traditional treatments or resistant to
multiple drugs have spread widely among patients in 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.California's program. In February 2010, the DPH Healthcare
Associated Infection (HAI) Program developed a statewide
antimicrobial stewardship program 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
SB 1311 | Page 4
Quality and Promotion at CDC, Infectious Disease Association
of California, and SHEA. According to the DPH website,
current program activities include:
a. Spotlight on ASP Project and Enrollment Questionnaire
will help define ASP and at the same time spotlight
volunteer hospitals that want to highlight and share with
others their ASP progress;
b. 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;
c. Consultative advice and practical evidence to facilities
in order to gain administrative, pharmacy and provider
buy-in;
d. Regional collaborations among hospitals with similar
difficulties and/or healthcare systems so that facilities
can learn from one another about strategies;
e. Developing recommendations on internal and external
outcome antimicrobial metrics with a group of antimicrobial
stewardship experts across California;
f. Educating long-term care facilities on the benefits of
ASPs and conducting research to better study the efficacy
of antimicrobial oversight in the long-term care setting;
and,
g. Defining activities that comprise ASPs in California
hospitals.
4.Prior legislation. SB 158 (Florez), Chapter 294, Statutes of
2008, established an infection surveillance, prevention, and
control program within DPH to provide oversight of hospital
prevention and reporting of general acute care
hospital-associated infections, expanded the responsibilities
of DPH's 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 1311 | Page
5
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.
5.Support. The California Hospital Association (CHA) writes
that improving the use of antibiotics is an important patient
safety and public health issue as well as a national priority.
A growing body of evidence demonstrates that hospital-based
programs dedicated to improving antibiotic use can both
optimize the treatment of infections and reduce adverse events
associated with antibiotic use. CHA states that these
programs help clinicians improve the quality of patient care
and improve patient safety through increased infection cure
rates, reduced treatment failures, and increased frequency of
correct prescribing for therapy and prophylaxis.
SB 1311 | Page 6
6.Should the requirements under this bill be applied to other
settings? This bill applies to acute care hospitals.
However, according to DPH, the federal Department of Health
and Human Services and the Center for Medicare and Medicaid
Services stipulate that long-term care facilities should use
antibiotics appropriately and encourage utilization of a
consulting pharmacist to provide oversight. Additionally,
citing existing California law that requires hospitals to
monitor and evaluate the utilization of antibiotics, the IDSA,
SHEA and Pediatric Infectious Disease Society issued a policy
statement in April 2012 suggesting the implementation of ASPs
throughout health care.
SUPPORT AND OPPOSITION :
Support: California Hospital Association
Oppose: None received.
-- END --