BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 361
---------------------------------------------------------------
|AUTHOR: |Hill |
|---------------+-----------------------------------------------|
|VERSION: |February 24, 2015 |
---------------------------------------------------------------
---------------------------------------------------------------
|HEARING DATE: |April 8, 2015 | | |
---------------------------------------------------------------
---------------------------------------------------------------
|CONSULTANT: |Vince Marchand |
---------------------------------------------------------------
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.
SB 361 (Hill) Page 2 of ?
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
SB 361 (Hill) Page 3 of ?
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.
SB 361 (Hill) Page 4 of ?
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:
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
SB 361 (Hill) Page 5 of ?
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.
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
SB 361 (Hill) Page 6 of ?
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,
SB 361 (Hill) Page 7 of ?
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:
a. 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.
b. 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
-- END --