[Senate Hearing 113-812]
[From the U.S. Government Publishing Office]
S. Hrg. 113-812
U.S. EFFORTS TO REDUCE HEALTHCARE-ASSOCIATED INFECTIONS
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HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED THIRTEENTH CONGRESS
FIRST SESSION
ON
EXAMINING UNITED STATES EFFORTS TO REDUCE HEALTHCARE-ASSOCIATED
INFECTIONS
__________
SEPTEMBER 24, 2013
__________
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
TOM HARKIN, Iowa, Chairman
BARBARA A. MIKULSKI, Maryland LAMAR ALEXANDER, Tennessee
PATTY MURRAY, Washington MICHAEL B. ENZI, Wyoming
BERNARD SANDERS (I), Vermont RICHARD BURR, North Carolina
ROBERT P. CASEY, JR., Pennsylvania JOHNNY ISAKSON, Georgia
KAY R. HAGAN, North Carolina RAND PAUL, Kentucky
AL FRANKEN, Minnesota ORRIN G. HATCH, Utah
MICHAEL F. BENNET, Colorado PAT ROBERTS, Kansas
SHELDON WHITEHOUSE, Rhode Island LISA MURKOWSKI, Alaska
CHRISTOPHER S. MURPHY, Connecticut
ELIZABETH WARREN, Massachusetts
MARK KIRK, Illinois
TIM SCOTT, South Carolina
Pamela Smith, Staff Director
Lauren McFerran, Deputy Staff Director and Chief Counsel
David P. Cleary, Republican Staff Director
(ii)
C O N T E N T S
__________
STATEMENTS
TUESDAY, SEPTEMBER 24, 2013
Page
Committee Members
Harkin, Hon. Tom, Chairman, Committee on Health, Education,
Labor, and Pensions, opening statement......................... 1
Alexander, Hon. Lamar, a U.S. Senator from the State of
Tennessee, opening statement................................... 2
Whitehouse, Hon. Sheldon, a U.S. Senator from the State of Rhode
Island......................................................... 25
Isakson, Hon. Johnny, a U.S. Senator from the State of Georgia... 26
Murphy, Hon. Christopher S., a U.S. Senator from the State of
Connecticut.................................................... 28
Burr, Hon. Richard, a U.S. Senator from the State of North
Carolina....................................................... 30
Casey, Hon. Robert P., Jr., a U.S. Senator from the State of
Pennsylvania................................................... 32
Baldwin, Hon. Tammy, a U.S. Senator from the State of Wisconsin.. 33
Witnesses--Panel I
Conway, Patrick, M.D., MSc, Chief Medical Officer and Director,
Center for Clinical Standards and Quality, and Acting Director,
Center for Medicare and Medicaid Innovation, Baltimore, MD..... 4
Prepared statement........................................... 6
Bell, Beth, M.D., M.P.H., Director, National Center for Emerging
and Zoonotic Infectious Diseases, Centers for Disease Control
and Prevention, Atlanta, GA.................................... 13
Prepared statement........................................... 14
Witnesses--Panel II
Staunton, Ciaran, The Rory Staunton Foundation, New York, NY..... 36
Prepared statement........................................... 39
Perlin, Jonathan B., M.D., Ph.D., MSHA, FACP, FACMI, President,
Clinical and Physician Services and Chief Medical Officer, HCA/
Hospital Corporation of America, Nashville, TN................. 43
Prepared statement........................................... 45
Kiani, Joe, Founder, The Patient Safety Movement, Irvine, CA..... 46
Prepared statement........................................... 48
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.:
Proposed Regulations: New York State Department of Health.... 64
Response by Patrick Conway, M.D., MSc to questions of Senator
Murphy..................................................... 70
Response by Beth Bell, M.D., M.P.H. to questions of:
Senator Harkin........................................... 71
Senator Casey............................................ 71
Senator Hagan............................................ 73
Senator Murphy........................................... 74
Response by Jonathan Perlin, M.D., Ph.D., MSHA, FACP, FACMI
to question of Senator Casey............................... 75
(iii)
U.S. EFFORTS TO REDUCE HEALTHCARE-ASSOCIATED INFECTIONS
TUESDAY, SEPTEMBER 24, 2013
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The committee met, pursuant to notice, at 10:05 a.m. in
room SD-430, Dirksen Senate Office Building, Hon. Tom Harkin,
chairman of the committee, presiding.
Present: Senators Harkin, Alexander, Casey, Whitehouse,
Baldwin, Murphy, Burr, and Isakson.
Opening Statement of Senator Harkin
The Chairman. The Committee on Health, Education, Labor,
and Pensions will please come to order. At the outset, I just
want to remind everyone that we have a vote scheduled at 11:45,
so we're going to try to get through this, if we can, as soon
as possible, because I doubt that we can get back after the
lunch hour.
In the late 1970s, a group of researchers began to examine
reports of patient deaths and injuries caused by anesthesia.
They found wide variation in quality and a disturbing incidence
of medical errors, leading to 6,000 deaths or serious injuries
annually. ABC network's 20/20 news program covered the study,
and the modern patient safety movement was born.
We are meeting today because more than 30 years later,
safety and quality in healthcare facilities remains a pressing
concern. Specifically, we're here to discuss a problem that has
bedeviled healthcare for decades--infections acquired while a
patient is being treated.
Every year, about 1.7 million people in the United States
get these healthcare-acquired infections. They impose
tremendous costs in dollars but, most tragically, in human
suffering. The CDC estimates that these infections cause 270
deaths every day, and a recent study shows that the five most
common hospital-acquired infections cost the system $10 billion
each year.
If you include all infections acquired in all settings, the
cost is between $30 billion and $45 billion annually. That's
money that could be spent on improving quality, reducing the
cost of care, or any number of other investments.
Just as dangerous as an infection picked up in the hospital
is the failure to properly detect and treat an infection. One
of our witnesses, Ciaran Staunton, will tell a tragic story
about his son that illustrates how the failure to detect can be
a fatal problem. I'll let Mr. Staunton tell his story, but let
me just say that his son died of an infection that was
detectable and survivable.
An Iowan wrote me last week with a similar story. Last
year, Vanessa's father, Wes Shubert, from Clear Lake, got a cut
on his right wrist. Here's what she wrote me:
``His doctor failed to prescribe any antibiotics.
Needless to say, it was downhill from that point. They
did an emergency surgery to remove the infection from
his knee, and then sent him home, even though I pled
with the medical staff to please observe Dad overnight
because something was not right.''
Less than 24 hours later, Vanessa's father was back in the
emergency room, and, tragically, he died shortly afterward of
sepsis.
This is one of the thorniest healthcare quality challenges
of our time. Federal and State governments are making
significant investments in quality improvement, investments
that both Dr. Bell and Dr. Conway will talk about in detail.
For the first time, public officials, providers, payers, and
other stakeholders have the tools to reward high-quality, not
high-volume, care. And, perhaps most importantly, we're
stopping payment for bad care that was included in the
Affordable Care Act.
Our witnesses will discuss these initiatives in depth, but
let me just touch on one of them. The Partnership for Patients,
started in spring 2011, is a public-private partnership with
over 3,700 participating hospitals. The work is starting to pay
off, as Dr. Conway will describe, and I read his testimony. The
hospital readmission rate is declining over the last 2 years,
translating to thousands of seniors staying home and healthy.
In the private sector, conscientious providers,
researchers, and academics have made great strides in improving
quality of care. Our second panel will discuss some of these
innovative approaches.
In Connecticut, the Public Health Department was recognized
last year with a Future of Public Health Award for its work in
reducing healthcare-associated infections in nursing homes. And
in another State, Rhode Island Hospital has reduced the
incidence of a particularly deadly infection by 70 percent.
Officials said that hospital-wide participation and cooperation
was essential to this success.
We need bold action, with everyone pulling in the same
direction. A study in the journal Health Affairs found that, on
average, a third of patients admitted to a hospital suffer a
medical error or other adverse event, 10 times greater than
what was previously thought. The most important lesson of
today's hearing is that these mistakes and tragedies are
avoidable. With hard work, innovation, transparency,
communication, and investment, we can win this fight.
I will turn to Senator Alexander for his opening statement.
Opening Statement of Senator Alexander
Senator Alexander. Thanks, Mr. Chairman. I thank you for
putting the spotlight on this disturbing and vitally important
part of our American healthcare system.
I've noticed--and I suppose anyone who's gone to the eye
doctor or gone to the hospital or taken a family member to the
hospital--that over the last several years, it seems like,
suddenly, on the walls have appeared all these little
sanitizing items, and the nurses and the doctors and other
healthcare workers are washing their hands every 5 minutes. It
seems that way, and I don't remember that happening at that
rate 5, 10, 15, or 20 years ago.
There's a growing awareness of the number of times that
Americans go to hospitals to get well, but in the process
become sick as the result of an infection. According to the
Centers for Disease Control and Prevention, that happens to
about 1 out of 20 people who are hospitalized, which is a very
high number. And that's not what one expects when you go to a
hospital. You expect some help in getting well, not some help
in getting ill.
We're going to hear more about sepsis today. We welcome the
families who have suffered tragedies as a part of that. But the
other disturbing element of this is the fact that in a number
of cases, the infections are caused by bacteria for which there
is not a cure or not an easy cure, and that number is
increasing. We'll hear more about that today as well.
One out of 20 patients, according to CDC, goes to the
hospital, gets an infection, and in a growing number of cases,
the infection is not the kind of an infection that can be
cured. This takes a real human toll. Senator Harkin has talked
about the financial toll as well.
It happens even at the Clinical Center of the National
Institutes of Health, where they suffered an outbreak of an
antibiotic-resistant bacteria last year. Through quick work,
they did the detective work that the Chairman talked about, but
not before seven patients died.
I'm proud that Tennessee's own Hospital Corporation of
America has collaborated with several partners, including CDC,
and published a study on effective prevention practices. I look
forward to hearing from their chief medical officer in the
second panel.
Prevention and elimination of healthcare-associated
infections is crucially important. We have taken some steps
with the Generating Antibiotic Incentives Now Act to try to
make it easier for new products to be introduced into the
developmental pipeline to deal with these bacteria that are
resistant to cure. But we have a ways to go.
I look forward to the hearing. This is one of those issues
that Congress is involved in that is relevant to every single
American family, because any of us might one day find ourselves
or a loved one in the hospital, and we don't like the statistic
that 1 out of 20 might get an infection while there, and some
of those infections are resistant to medicine that would cure
them.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Alexander. And not to put
too fine a point on it, but I think this is one of the most
important hearings this committee has had or will have in this
entire year. I say that because the more I've looked at it and
the more I've been briefed on this, the more it is clear that
with changes in approaches and structuring--some of the things
I mentioned--this is not intractable.
This can be solved. But it's going to take some concerted
effort, as I said, and some innovations that come from people
who are here that are witnesses today and others. But this is
something that we can do. And I'm sure I speak for my friend,
Senator Alexander--we mean to get to the bottom of this and
figure out what we can do to set up the systems to really
attack this issue.
We have two panels. Our first panel will be Dr. Patrick
Conway. We welcome him back. He has a lot of responsibility
these days as Acting Director of the Center for Medicare and
Medicaid Innovation and also as the Chief Medical Officer for
CMS. At the Innovation Center, Dr. Conway oversees development
and implementation of innovative programs that aim to increase
healthcare quality, decrease cost, and improve community
health.
As the Chief Medical Officer, he is responsible for quality
measures in Federal health programs, quality improvement,
clinical standards, certification of all providers, and
coverage decisions for treatments and services. Previously, he
was director of Hospital Medicine and an associate professor at
Cincinnati Children's Hospital.
We welcome you back.
We also welcome back Dr. Beth Bell, the Director of the
National Center for Emerging and Zoonotic Infectious Diseases
at the Centers for Disease Control and Prevention. Dr. Bell is
responsible for CDC's efforts in responding to a broad range of
emerging and established threats, including healthcare-
associated infections. Previously, Dr. Bell served in multiple
leadership roles at CDC, including the agency's response to the
2001 anthrax attacks and the 2009 H1N1 influenza pandemics.
We thank you for being here with us today, Dr. Bell.
Both of your statements will be made a part of the record
in their entirety. I'll ask you, if you could, to just take 5
to 7 minutes and summarize those so we can get to questions.
Dr. Conway, please proceed.
STATEMENT OF PATRICK CONWAY, M.D., MSc, CHIEF MEDICAL OFFICER
AND DIRECTOR, CENTER FOR CLINICAL STANDARDS AND QUALITY, AND
ACTING DIRECTOR, CENTER FOR MEDICARE AND MEDICAID INNOVATION,
BALTIMORE, MD
Dr. Conway. Chairman Harkin, Ranking Member Alexander, and
members of the committee, thank you for the opportunity to
discuss our work at the Centers for Medicare and Medicaid
Services to improve the quality of care and patient safety in
our health system.
Healthcare-acquired infections, or HAIs, are a serious
national concern. About 1 of every 20 patients gets an
infection while hospitalized. HAIs are one of the most common
types of complications for patients who are hospitalized and,
as was noted, result in billions of dollars of excess
healthcare costs.
I distinctly remember in training as an intern an infant
who died in our neonatal ICU from a central line bloodstream
infection. The family was devastated. My attending, consistent
with what was known at the time, said these infections just
happen and are not preventable. Fortunately, we now know that
most HAIs are preventable, and we are making significant
national progress in preventing them.
I currently practice as a physician attending, taking care
of hospitalized patients and their families on weekends, and
our goal is to prevent all infections. The good news is that we
are making progress nationally. Over the last 4 years, central
line bloodstream infections have declined 44 percent, and
surgical site infections have declined 20 percent nationally.
From 2007 to 2011, the average monthly 30-day all-cause
readmission rate was typically 19 percent or above. Toward the
end of 2012, the rate declined to approximately 18 percent.
It's now consistently below 18 percent nationally in 2013 and
continues to decline. This decrease represents nearly 100,000
Medicare beneficiaries staying home and healthy instead of
returning to the hospital.
The Hospital Engagement Networks and the Partnership for
Patients, a public-private collaboration, are delivering
promising early results. These networks are making improvements
across 10 areas of focus. These include central line
infections, readmissions, and early elective deliveries, among
others. All 26 networks had at least a 30 percent improvement
in at least six or more areas of harm reduction--dramatic
results.
For example, more than 1,000 birthing hospitals in the
partnership have generated a 44 percent reduction in early
elective deliveries, helping to prevent costly neonatal ICU
stays and the poor health outcomes of preterm birth. Some of
the networks have reduced central line associated infections to
close to zero.
We are making progress in preventing HAIs through three
main mechanisms: financial incentives to improve quality;
performance measures; and public reporting to improve
transparency and the spreading and scaling of effective
interventions, especially through coordination with our
partners, including CDC.
First, CMS is transforming from a passive payer to an
active purchaser of higher value healthcare services. Since
2008, Medicare payment policy refused to pay for care related
to certain identified healthcare-acquired conditions, or HACs,
that are not present on admission. This year, we finalized
measures for the Healthcare-Acquired Condition Program,
including measures of HAIs, which will negatively adjust
payments for hospitals in the bottom quartile of performance.
Additionally, in 2014, Hospital Value-Based Purchasing will
redistribute an estimated $1.1 billion to hospitals based on
their performance, including measures of infection and care
coordination. The Affordable Care Act also established the
Hospital Readmissions Reduction Program, which reduced Medicare
payments to hospitals that have excess readmissions, beginning
in 2012.
Our second major focus to improve care is coordinated
aligned performance measurements that help providers and
consumers better understand the quality of care and make more
informed decisions. Consumer-focused Web sites, including
Hospital Compare, are using quality measures to improve
healthcare transparency, and transparency drives improvement.
Finally, we are working to ensure that the healthcare
delivery system continues to improve and transform through the
testing and spreading of effective interventions. For example,
Quality Improvement Organizations work cooperatively with
physicians, hospitals, and others to disseminate research
evidence, share best practices, and provide technical
assistance to decrease infections and coordinate care. This
helps make a very real difference.
For example, a Florida QIO alerted us that a hospital in
their area had central line infection rates at two to three
times the national rate and high rates of mortality. We
immediately intervened with a corrective action plan and
leveraged the expertise from CDC and AHRQ. There have been no
central line infections since we put in place this new system
of quality controls. We also help spread learning from high
performing systems to hospitals across the Nation.
By aligning payment incentives and checking our progress
through quality measures, we, in collaboration with our
partners in HHS and the private sector, have made significant
improvements in reducing HAIs and improving care and patient
safety. We partner with nonprofit organizations, such as the
Patient Safety Movement Foundation, who you will hear from;
hospitals; physician groups; consumers; States; and so many
others to decrease HAIs and improve patient safety.
In my last role, leading delivery system improvement at
Cincinnati Children's, our goal was to eliminate patient harm
across our system. In my current role at CMS, our goal is to
reduce and eventually eliminate patient harm and keep patients
safe across our Nation.
We want all health systems focused on safety first. We
recognize more work is needed to innovate and find the
solutions to ensure that no patient suffers from an infection
or condition that could have been prevented. Our work has saved
thousands of lives, but we must stay focused on keeping all
patients safe.
Your interest today contributes to that progress, and I'll
be happy to hear your concerns or answer your questions about
this important lifesaving subject. Thank you for your time.
[The prepared statement of Dr. Conway follows:]
Prepared Statement of Patrick Conway, M.D., MSc
Chairman Harkin, Ranking Member Alexander, and members of the
committee, thank you for the opportunity to discuss our work at the
Centers for Medicare & Medicaid Services (CMS) to improve the quality
of care and patient safety at our Nation's hospitals. Through Medicare,
Medicaid, the Children's Health Insurance Program (CHIP), and, in 2014,
the private health insurance Marketplaces, CMS helps provide health
care coverage to over 100 million Americans. We are committed to
ensuring that all our beneficiaries receive the highest possible
quality of care, and we continually strive to achieve better health
outcomes at a lower cost.
Improving patient safety at our Nation's hospitals is an important
goal for the U.S. Department of Health and Human Services (HHS) and
CMS. According to the Centers for Disease Control and Prevention (CDC),
about 1 of every 20 patients gets an infection while hospitalized.\1\
Healthcare-associated infections (HAIs) are likely the most common type
of complication for patients who are hospitalized.\2\ HAIs result in
billions of dollars of excess healthcare costs.
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\1\ http://www.cdc.gov/hai/burden.html.
\2\ http://www.psnet.ahrq.gov/primer.aspx?primerID=7.
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HHS is committed to improving patient safety by reducing HAIs
across the health care system, with hospitals as a prime arena for
priority attention, as outlined in the HHS National Action Plan to
Prevent Healthcare-Associated Infections: Roadmap to Elimination.\3\
One of the Agency Priority Goals is to reduce, by September 30, 2013,
the national rate of HAIs by demonstrating significant, measurable
reductions in hospital-acquired central line-associated bloodstream
infections (CLABSI) and catheter-associated urinary tract infections
(CAUTI). Despite the significant burden of HAIs in the United States
and the growing threat of antibiotic resistant pathogens, most HAIs are
preventable; and the coordinated efforts of CDC, CMS, the Agency for
Healthcare Research and Quality (AHRQ), and other HHS agencies have
resulted in significant reductions in some HAIs. Notably, CDC data
indicate that over the last 4 years CLABSIs have declined 44 percent
and surgical-site infections (SSI) have declined 20 percent. Last week,
CDC also published new data showing dramatic declines in invasive
(life-threatening) Methicillin-resistant Staphylococcus aureus (MRSA)
infections. This study estimated that over 30,000 fewer invasive MRSA
infections occurred in all settings in 2011 compared with 2005, and
over 9,000 fewer deaths occurred among individuals hospitalized with
MRSA. The study also showed a 54 percent decline in serious MRSA
infections occurring among patients during hospitalization between 2005
and 2011.
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\3\ http://www.hhs.gov/ash/initiatives/hai/actionplan/.
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There has also been success in the long-term national declines in
CLABSIs. In a recently released paper, CDC authors estimated that
between 1990 and 2010, between 104,000 and 198,000 CLABSIs were
prevented among critical care patients in the United States. In an
analysis currently undergoing peer review, CDC estimated the net
economic benefits of preventing CLABSIs in Medicare and Medicaid
patients in critical care from 1990 to 2008 ranged from $756 million to
$1.9 billion with the corresponding net benefits per case averted
ranging from $16,550 to $24,060.
Additionally, CMS has made progress in preventing unnecessary
readmissions. From 2007 to 2011, the average monthly 30-day all-cause
readmission rate was typically 19 percent or above. Toward the end of
2012, the rate had declined to approximately 18 percent and is now
below 18 percent nationally in 2013. If you compare the last 12 months
to the baseline in 2010 through 2011, the decrease represents nearly
100,000 Medicare beneficiaries staying home instead of returning to the
hospital. This decrease is an early sign that our focus on improving
quality and care coordination is beginning to have an impact.
CMS is focused on improving patient safety and care in hospitals
through payment incentives, transparency in quality measurement and
public reporting, and the testing, scaling, and spreading of effective
interventions through quality improvement collaboratives and clinician
training. The Affordable Care Act and other laws are now enabling CMS
to support better health and promote quality improvement and greater
value while creating an environment that fosters innovation. Our
objective is to ensure quality health care for generations to come--not
just for Medicare and Medicaid beneficiaries, but for all people who
depend on our Nation's health care system.
financial incentives to improve quality
In the past, hospitals had little financial incentive to improve
the quality of their care because Medicare and other purchasers paid
hospitals for treating infections or errors even when they could have
been prevented. Now, Medicare, State Medicaid programs, and many
private sector health plans and purchasers, are moving rapidly to
change payment systems to reward better outcomes instead of volume of
services. In Medicare, the combined effect of the Hospital-acquired
Conditions (HAC) Program, Hospital Value-Based Purchasing, Hospital
Inpatient Quality Reporting Program, and the Hospital Readmissions
Reduction Program already are creating strong incentives for hospitals
to preempt infections and errors. CMS is working to transform from a
passive payer to an active purchaser of higher-value health care
services using the following tools.
Hospital Acquired Conditions and Healthcare-Acquired Infections
Since 2008, Medicare payment policy has further encouraged
hospitals to identify ways to prevent certain HACs or conditions that
are not present on admission. For these designated conditions, while
Medicare pays hospitals the standard rates for the original admission,
we no longer pay hospitals for the additional costs associated with the
care and treatment of these HACs. In 2012, CMS added additional HACs to
the list of conditions that would warrant CMS eliminating additional
payments.\4\ CMS clinical quality experts have worked closely with
public health and infectious disease experts from CDC to identify and
select additional preventable HACs, including HAIs to add to this list.
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\4\ A complete list of HAC categories and their corresponding
complication or comorbidity (CC) or major complication or comorbidity
(MCC) codes finalized for fiscal year 2013 can be found at: http://
www.cms.gov/Medicare/Medicare-fee-for-service-Payment/HospitalAcqCond/
Down
loads/HACFactsheet.pdf.
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CMS has issued similar guidelines for Medicaid to incentivize
provider-level quality improvement and cost-savings for States by
requiring States to reduce Medicaid payments for hospital errors.
Medicaid also funded the Transformation Grants, which aim to improve
Medicaid's effectiveness and efficiency. For example, the
Transformation Grants funded efforts to reduce central-line infections
for premature infants in neonatal intensive care units.
In addition, section 3008 of the Affordable Care Act established
the HAC Reduction Program to further reduce HACs and improve patient
quality. CMS will begin implementing this program starting in fiscal
year 2015 with the performance period starting this year. Under the HAC
Reduction Program, hospitals in the lowest performing quartile with
respect to the overall rate of certain HACs will see their payments
reduced by 1 percent, providing an incentive for those hospitals to
reduce the burden of HACs in their facilities.
Hospital Value-Based Purchasing Program
CMS has implemented programs to strengthen payment incentives to
improve the quality of hospital care furnished to traditional fee-for-
service Medicare beneficiaries. As required by the Affordable Care Act,
beginning with October 2012 discharges, CMS began adjusting Medicare
payments to most hospitals for inpatient acute care services based on
how well they performed on a series of quality measures. This program,
called the Hospital Value-Based Purchasing Program, is a carefully
crafted program that was developed in a manner that incorporated
significant stakeholder feedback.
The quality measures used in the program are consistent with
evidence-based clinical practices for the provision of high-quality
care. Hospitals are scored on improvement as well as achievement on a
variety of quality measures. The higher a hospital's total performance
score during a performance period, the higher the hospital's value-
based incentive payment will be for a subsequent fiscal year. For
fiscal year 2014, the Hospital Value-Based Purchasing Program will
redistribute an estimated $1.1 billion to hospitals based on their
quality performance. We recently added the CLABSI measure beginning
with the fiscal year 2015 program, and we finalized the addition of the
CAUTI and SSI measures to the program for the fiscal year 2016 program.
In the future, CMS expects to add new measures to the program that
focus on patient health outcomes, cost reduction, and HAIs that
significantly impact Medicare beneficiaries and reflect substantial
quality of care variation among hospitals.
Hospital Inpatient Quality Reporting Program
The Hospital Inpatient Quality Reporting Program gives hospitals a
financial incentive to report the quality of their inpatient services
by tying the reporting of designated quality measure data to their
ability to be paid the full amount of the annual update to the Medicare
inpatient payment rate. CMS has adopted a number of HAI measures for
the program, and some of this data is collected on CMS' behalf by the
CDC through that agency's National Healthcare Safety Network (NHSN).
The CDC has developed the HAI measures that are used in the Hospital
IQR Program, and provides hospitals with additional analytic tools that
enable them to assess their rates of performance and identify where
additional efforts are needed. The HAI measures that hospitals
currently report to the NHSN as part of the Hospital IQR Program are
CLABSI, CAUTI, SSI, Clostridium difficile, and MRSA data.
Hospital Readmissions Reduction Program
The Affordable Care Act also established the Hospital Readmissions
Reduction Program, which reduces Medicare payments to hospitals that
have excess readmissions beginning in October 2012. Currently, we
measure the readmissions rates for three very common and expensive
conditions for Medicare beneficiaries--heart attack, heart failure, and
pneumonia. We recently finalized expanding the readmissions program
with measures for two more common conditions--chronic obstructive
pulmonary disease and knee and hip replacements. These measures will be
added to the program in fiscal year 2015.
The readmissions program--together with other Affordable Care Act
payment and delivery reforms--is already having a positive impact. As
discussed above, we are observing a significant decrease in the rate of
patients returning to the hospital after being discharged. This
decrease is an early sign that our payment and delivery reforms are
having an impact.
quality measurement and public reporting
In order to achieve meaningful quality improvements, performance on
care delivery and outcomes should be measured using reliable,
nationally endorsed measures. These measures must provide information
that is timely, actionable, and meaningful to both providers and
patients. CMS is aligning the existing reporting requirements for the
financial incentive programs described above, and encouraging the
adoption of broad scale electronic reporting of quality data. These
quality measures are generally endorsed by the National Quality Forum,
meet clinical validity and reliability requirements, and align with the
National Quality Strategy. We are increasing our focus on patient-
centered outcome measures that matter most for improving health. Our
vision for the future of quality reporting is to implement a unified
set of electronic quality measures and e-reporting requirements to
synchronize and align CMS quality programs, reduce provider burden, and
maximize efficiency and improvement.
Electronic Health Records Incentive Programs and Meaningful Use
The American Recovery and Reinvestment Act of 2009 provided support
to physicians and other providers who adopt electronic health records
by establishing the Medicare and Medicaid Electronic Health Records
(EHR) Incentive Programs. EHRs can make it easier for physicians,
hospitals, and others serving Medicare and Medicaid beneficiaries to
evaluate patients' medical status, eliminate redundant and costly
procedures, and provide high-quality care. Through diagnostic and
therapeutic decision support, clinical alerts and reminders, medication
reconciliation, and built-in safeguards, EHRs can help providers make
safe, effective decisions and provide high-quality care for their
patients.
Participation in the Medicare and Medicaid EHR Incentive Programs
has been robust. Approximately 80 percent of all eligible hospitals and
critical access hospitals in the United States have received an
incentive payment in the Medicare and Medicaid EHR Incentive Programs
for adopting, implementing, upgrading, or meaningfully using certified
EHR technology. As of July 2013, over 315,000 hospitals, doctors and
other healthcare professionals have become meaningful users.\5\
Additionally, more than 50 percent of eligible professionals have
adopted EHRs and received incentive payments from Medicare and
Medicaid. Forty-nine States and four territories have launched their
Medicaid EHR Incentive Programs. Those States have paid almost $2.25
billion in incentive payments to over 99,000 Medicaid-eligible
professionals.
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\5\ Summary of the EHR Incentive Program. July 2013. http://
www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/
Downloads/July2013_PaymentandRegistration
SummaryOverview.pdf.
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Coordinating Quality Reporting Programs
Though the quality-reporting and performance-based payment programs
described above originate through separate statutory authorities, CMS
strives to streamline reporting mechanisms across programs in order to
reduce the burden on providers. For example, quality measures in the
Inpatient Quality Reporting Program supply data underlying payment
adjustments in the Readmissions Reduction Program as well as the Value-
Based Purchasing Program. Similarly, CMS has coordinated with agencies
throughout HHS to consolidate similar quality measures and to support
adoption of high-priority measures based on stakeholder input and input
from the National Quality Forum's Measures Application Partnership. In
fiscal year 2014, we are also aligning the submission of hospital
clinical quality measures under the Medicare EHR Incentive program with
the hospital Inpatient Quality Reporting (IQR) program. Hospitals will
now have the option of submitting 16 of the IQR measures
electronically, which would satisfy the CQM component of the Medicare
EHR Incentive program as well as the reporting requirement for these
measures under the IQR program.
Transparency for Consumers Through Hospital Compare and HealthCare.gov
Clear, understandable information that is easy to access helps
consumers make informed decisions about their health care, and gives
them an important role in reducing and preventing HAIs. CMS created the
Hospital Compare Web site \6\ to better inform health care consumers
about a hospital's quality of care. This tool, which includes CDC's
NHSN HAI measure results and data, shows a hospital's performance on a
wide variety of quality measures, including certain measures of
healthcare infections. In the coming years, additional measures will be
added to the Hospital Compare Web site, making this an even richer
source of information for consumers.
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\6\ For more information on the Hospital Compare Web site please
visit: http://www.medicare.
gov/hospitalcompare.
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Based on priorities identified in the National Quality Strategy,
and authority in the Affordable Care Act, CMS is interested in
promoting effective quality measurement through the Marketplace. To
that end, HHS's strategy for establishing quality-reporting
requirements to ensure that high quality health care is delivered
through the Marketplace includes the consideration of existing relevant
quality measure sets and quality improvement initiatives in conjunction
with other factors, such as characteristics of the Marketplace
population. HHS is engaging States, employers, consumer advocates,
health insurance issuers, and other stakeholders as we continue to
develop these quality-related requirements, and we issued a Request for
Information on November 27, 2012. CMS intends to propose a phased
approach to quality reporting and display standards for all
Marketplaces. CMS intends that no new quality reporting standards for
qualified health plans and Marketplaces will be in place until 2016
(other than those related to accreditation, if applicable), which
allows time to develop standards appropriately matched to the
Marketplace enrollee population and plan offerings. Until final
regulations are issued, state-based Marketplaces would have the choice
of adopting a similar approach or implementing their own quality
reporting standards immediately and over time. This information will
eventually be available for consumer-use on the HealthCare.gov Web
site.
CMS recently released new datasets to promote transparency. This
includes a dataset on hospital charges, including information comparing
the charges for services that may be provided during the 100 most
common Medicare inpatient stays.\7\ Moreover, CMS also recently
released selected hospital outpatient data, including estimates for
average charges, for 30 types of hospital outpatient procedures.\8\ It
also released county-level data on Medicare spending and utilization in
an easy-to-use dashboard format.\9\ This data enables comparisons
between the amounts charged by individual hospitals within local
markets, and nationwide, for services that may be provided during
similar inpatient stays. CMS has also made approximately $87 million
available to help States to establish and enhance effective Rate Review
programs as well as to enhance or establish data centers that increase
health pricing transparency. The data centers' work helps consumers
better understand the comparative price of procedures in a given region
or for a specific health insurer or service setting. Businesses and
consumers alike can use these data to drive decisionmaking and reward
cost-effective provision of care.
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\7\ For additional information on the Medicare Provider Charge
Data, please see: http://www.cms.gov/Research-Statistics-Data-and-
Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/
index.html.
\8\ For additional information on the Outpatient Medicare Provider
Charge Data, please see: http://www.cms.gov/Research-Statistics-Data-
and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-
Data/Outpatient.html.
\9\ For additional information on the Geographic Variation
Dashboard, please see: http://www.cms.gov/Research-Statistics-Data-and-
Systems/Statistics-Trends-and-Reports/Medicare-Geographic-Variation/
GV_Dashboard.html.
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Consumer-focused Web sites, including Hospital Compare and
Healthcare.Gov, are using quality measures to improve healthcare
transparency. These sites allow consumers to view and compare
information about the insurance plans and hospitals in their area, and
pick the one that is best for them and their families. Through publicly
reported quality measures, consumers and payers are better able to
compare costs, review treatment outcomes, assess patient satisfaction,
and hold providers accountable. This is done while ensuring the
protection of personal health information and adjusting for factors
beyond providers' control. Reporting also provides important resources
and motivation for clinicians and other providers to improve
performance.
scaling and spreading effective interventions for quality improvement
As mentioned earlier, significant progress has been made to reduce
HAIs. With this success, CMS has expanded its focus to ensure that
quality continues to improve and the healthcare delivery system
continues to transform through the testing and spreading of effective
interventions.
Quality Improvement Organizations
Public and private efforts to support providers' desire to deliver
higher quality care are critically important. These include programs
sponsored by provider organizations and clinical specialty groups and
quality improvement organizations (QIOs) that work cooperatively with
physicians, hospitals, nursing homes, home health agencies, and others
to disseminate research evidence to the point of care, share best
practices and provide technical assistance.
Through large-scale learning networks, QIOs accelerate the pace of
change and rapidly spread best practices. Improvement initiatives
encourage innovation, respond to community needs, and lead the way to
patient-centered care by including an active role for Medicare
beneficiaries.
Some of the QIOs' current initiatives include contributing to the
goal of achieving significant reductions in HACs, including HAIs;
working with nursing homes to reduce pressure ulcers; reducing CLABSIs;
reducing re-hospitalizations by engaging communities to improve the
quality of care for beneficiaries as they transition between settings;
and boosting population health by improving use of electronic health
records for care management.\10\ Additionally, CMS and CDC collaborate
using HAI data to target prevention with the QIO networks.
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\10\ Details about each of these projects is available at http://
www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/QualityImprovementOrgs/Current.html.
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Survey & Certification
The survey and certification program of CMS is designed to ensure
that providers and institutional suppliers comply with the applicable
health and safety standards. Many types of facilities that participate
in Medicare or Medicaid are subject to unannounced, onsite inspections
by State or Federal surveyors to be certified under those programs.
Currently, the CMS Survey & Certification Group oversees compliance
with health and safety standards developed in coordination with the CDC
for more than 271,000 health care facilities of different types,
including hospitals, laboratories, nursing homes, home health agencies,
hospices, and end-stage renal disease facilities. For example, CMS is
collaborating with CDC to expand survey and oversight capacity of non-
acute healthcare settings and develop a new tool that State inspectors
are using to ensure the quality of care in ambulatory surgical centers.
Partnership for Patients
The nationwide Partnership for Patients initiative aims to avert
millions of preventable HACs and reduce hospital readmissions over 3
years, while providing savings to Medicare and Medicaid by reducing
complications and readmissions during the transition from one care
setting to another. Over 3,700 hospitals, as well as physicians and
nurses' organizations, consumer groups, employers, and other major
stakeholders, have pledged to help achieve the Partnership's goals.
Twenty-six Hospital Engagement Networks (HENs), which work at the
national, regional, State, or hospital system levels, are identifying
best practices and solutions in reducing HACs and readmissions and
disseminating information to health care providers and institutions,
nationwide. The HENs are focused specifically on 10 high-priority
areas.\11\ Associations and hospital systems like the American Hospital
Association, Ascension Health, and the Michigan Hospital Association
are serving as hospital engagement networks.
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\11\ The Partnership for Patients 10 safety areas of focus are:
adverse drug events, CAUTI, CLABSI, injuries from falls and immobility,
obstetrical adverse events including early elective deliveries,
pressure ulcers, SSI, venous thromboembolism, ventilator-associated
pneumonia, and hospital readmissions.
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Work by hospital engagement networks that are funded by CMS's
Center for Medicare and Medicaid Innovation (Innovation Center) is
buttressed by collaboration and alignment of other Federal and private
partners. Hundreds of private partners team with HENs and Federal
programs to spread best practices. As one example, the American
Congress of Obstetricians and Gynecologists works in partnership with
CMS, HRSA, and others to support their members in taking actions to
reduce early elective deliveries performed without medical indications,
which are known to cause harm to babies.
Initial emerging results are encouraging. For example, more than
1,000 birthing hospitals in the Partnership have already generated a 48
percent reduction in early elective deliveries. Improvements are being
seen across nearly all other hospital-
acquired conditions targeted by the Partnership. The Partnership for
Patients is achieving early promising results, demonstrating the
potential to accomplish national patient safety goals through
collaborative improvement.
CMS's Innovation Center
The Affordable Care Act provided CMS with valuable tools to test
methods to improve the health care delivery system by creating the
Innovation Center. The Innovation Center is focused on testing new
payment and service delivery models to reduce program expenditures
while preserving or enhancing the quality of care furnished. The
Innovation Center enables CMS to quickly and efficiently develop
innovative payment and service delivery models along with a broad range
of stakeholders. Some of the models being tested by the Innovation
Center include efforts to reduce unnecessary hospital admissions among
residents of nursing homes; improve care coordination for beneficiaries
in Accountable Care Organizations; and incentivize primary care
providers to offer high-quality, coordinated care. While the work of
the Innovation Center tests many payment and service delivery models,
these initiatives are only a part of our efforts to build a health care
delivery system that will better serve all Americans.
The Community-Based Care Transition Program supports 101 community-
based organizations working in partnership with 432 acute-care
hospitals to help high-risk Medicare beneficiaries residing in 40
States make successful transitions from hospital to home or to another
post-hospital setting. Hospitals are a logical focal point for efforts
to reduce readmissions, since the quality of care during a
hospitalization and the discharge planning process can have an impact
on whether a patient will continue to heal or return. However, it is
clear that there are multiple factors along the care continuum that
affect readmissions. The program links acute-care hospitals with home-
and community-based service providers through formal partnerships.
These partnerships between traditional medical providers and local
social service providers are believed to be critical in reducing
avoidable hospital readmissions among high-risk Medicare beneficiaries.
The Innovation Center is also testing new ways to efficiently
deliver care and lower costs through its Health Care Innovation Awards.
Round One of these 3-year awards focused on engaging a broad set of
innovation partners to test new care delivery and payment models;
identify new models of workforce development and deployment; and
support innovators who can rapidly deploy care improvement models
through new ventures or expansion of existing efforts to new patient
populations. Collectively, these awardees are testing models designed
to address a broad range of health care challenges. These range from a
sepsis early recognition and response initiative to a multi-provider
collaboration to create community-wide health intervention teams that
help people get fast and appropriate care, reduce unnecessary
hospitalizations, and lower costs. Each model will be evaluated on its
ability to improve the quality of care and lower the cost for the
target population it is designed to serve.
The first round of Health Care Innovation Awards, ranging from
approximately $1 million to $26 million, were announced in May and June
2012 to 107 total participants. For example, the Methodist Hospital, in
partnership with the Texas Gulf Coast Sepsis Network, is receiving an
award to identify and treat sepsis before it progresses. Sepsis is the
sixth most common reason for hospitalization and typically requires
double the average length of stay. It complicates 4 out of 100 general
surgery cases, has a 30-day mortality rate of 1 in 20, and leads to
complications such as renal failure and cognitive decline. Through
improved training, evidence-based and systematic screening for sepsis,
and more timely treatment, Methodist Hospital and its partners aim to
prevent progression of the disease, resulting in reduced organ failure
rates, reduced mortality, reduced length of stay, improved patient
outcomes, and lower costs.
Coordination With Stakeholders
Collaboration among multiple stakeholders in the healthcare
community is necessary to spread and sustain reductions in HAIs on a
broad scale. Collaboration leverages the combined programmatic efforts
of stakeholders both across HHS and with external partners such as the
Departments of Defense and Veterans Affairs, State governments,
academic institutions, and provider and patient groups. For example,
CMS, CDC, AHRQ, and State health departments continue to collaborate on
HAI data-validation strategies to optimize the accuracy of data
reported. Another example is AHRQ's Comprehensive Unit-Based Safety
Program for CLABSI project, which, over the period 2008 through 2012,
reduced the rate of CLABSI by 41 percent in over 1,000 Intensive Care
Units across the country.
Additionally, various agencies across HHS collaborate to find
system integration solutions in order to obtain reliable national
estimates of HAIs for a more accurate view of the overall issue. To
ensure that all Departmental HAI prevention assets are fully leveraged
and coordinated, the Office of the Assistant Secretary for Health
oversees a Senior-Level Steering Committee for Prevention of HAIs. With
senior-level participation from across HHS, in 2009, this committee
released a National Action Plan for the Prevention of Healthcare
Associated Infections. This plan outlined opportunities and strategies
to decrease HAIs in acute-care hospitals. In June 2013, HHS released a
revised and updated version of the National Action Plan that expanded
HHS' coordinated efforts in HAI reduction to non-acute care settings
including ambulatory surgical centers, long-term care facilities, and
end-stage renal disease facilities.
HHS is strengthening and building new partnerships to amplify
prevention messages, promote the implementation of recommended
practices in hospitals, ambulatory surgical centers, end-stage renal
disease facilities, and long-term care facilities, and monitor progress
at the national, regional, and local levels. Through continued emphasis
on coordinating programs and strengthening our network of resources,
CMS and its partners are able to provide technical assistance, testing,
and financial support for the development and implementation of
strategies to prevent HAIs, particularly those focused at the level
where patient care occurs.
looking forward
By aligning payment incentives and checking our progress through
quality measures, we, in collaboration with our partners in HHS and the
private sector, have made significant improvements in reducing HAIs and
improving care and patient safety in hospitals. Through the work of the
QIOs, Partnership for Patients, and the Innovation Center, we are
beginning to test and develop new strategies that could lead to
broader, national improvement. We recognize, however, more work is
needed to innovate and find the solutions and technology to ensure that
no patient suffers from an infection or condition that could have been
prevented. Your interest today contributes to that progress, and I
would be happy to hear your concerns or answer your questions about
this important, lifesaving subject. Thank you for the opportunity to
testify.
The Chairman. Thank you, Dr. Conway.
Dr. Bell, welcome again and please proceed.
STATEMENT OF BETH BELL, M.D., MPH, DIRECTOR, NATIONAL CENTER
FOR EMERGING AND ZOONOTIC INFECTIOUS DISEASES, CENTERS FOR
DISEASE CONTROL AND PREVENTION, ATLANTA, GA
Dr. Bell. Chairman Harkin, Ranking Member Alexander,
members of the committee, thank you for the opportunity to
speak about CDC's activities to prevent healthcare-associated
infections, HAIs. CDC works 24/7 to save lives and protect
people from harm. Preventing HAIs is a very high priority for
CDC.
Before I begin, I want to extend my sympathies to the
millions of patients and families affected by HAIs each year.
They are people like Peggy Lillis, the 56-year-old mother of
two, a New York kindergarten teacher, who lost her battle with
Clostridium difficile, a deadly diarrheal infection. No patient
should be harmed by healthcare, and our ultimate goal is the
elimination of HAIs.
HAIs are infections that patients acquire while receiving
care. They are associated with increased mortality, with
greater costs, and can occur in any healthcare setting. As
previously noted, CDC data indicate that approximately 1 in 20
hospitalized patients develop HAIs, and over 1 million
infections occur each year across healthcare settings.
In hospitals alone, HAIs result in billions of dollars of
excess healthcare costs and contribute to the deaths of
thousands of patients every year. In the worst cases, HAIs can
lead to sepsis, a dangerous condition that can result in organ
failure and death. Primary prevention of HAIs stops a root
cause of sepsis.
Antibiotic resistance is one of our most serious health
threats and one of CDC's most significant concerns related to
HAIs. We estimate that one in five HAIs are antibiotic
resistant. Patients with these resistant infections are more
likely to die, and survivors have longer hospital stays.
Last week, we released a landmark report that presented a
first ever U.S. snapshot of the burden and threats posed by
antibiotic-resistant pathogens. Two of the three pathogens
urgently prioritized in the report are primarily healthcare
related--carbapenem-resistant Enterobacteriaceae, (CRE), and C.
difficile.
Despite the significant burden of HAIs and the growing
threat of antibiotic-resistant pathogens, most HAIs are
preventable, and the Nation has made significant progress in
reducing the incidence of some HAIs. CDC has taken a lead role
in addressing this important public health challenge. Data
released by us this week indicate that over the last 4 years,
central line associated bloodstream infections were reduced by
44 percent and surgical site infections by 20 percent.
We have also documented national declines in central line
infections over the longer term. In a recently released paper,
CDC authors estimated that between 1990 and 2010, between
104,000 and 198,000 central line infections were prevented
among critical care patients in the United States. CDC experts
have estimated that the prevention of these infections has
saved Medicare and Medicaid hundreds of millions of dollars,
and that for every $1 spent on CDC HAI activities, Medicare and
Medicaid saved, on average, $10.
Last week, CDC also published new data on dramatic declines
in MRSA infections. This study estimated that over 30,000 fewer
invasive MRSA infections occurred in hospital and non-hospital
settings in 2011 compared with 2005, and over 9,000 fewer
deaths occurred among individuals hospitalized with MRSA.
CDC's portfolio of activities is critical to improving the
national capacity to detect HAIs and protect patients and
communities. CDC's world class experts target HAIs and the
drug-resistant pathogens that can cause them by tracking HAIs
and progress toward prevention goals, by responding to emerging
threats through outbreak investigations, by developing
guidelines for HAI prevention and filling gaps in knowledge,
and by implementing prevention strategies with Federal and
State partners.
While some progress has been made, CDC is working with CMS
to ensure that the prevention gains we have seen thus far are
sustained and carried over to other infection types and
settings. We must address drug-resistant HAIs and C. difficile
and improve antibiotic use in all healthcare settings.
We are launching a new component of the National Healthcare
Safety Network, the Nation's largest HAI monitoring system,
that will electronically measure and help facilities improve
antibiotic use. For all of these infection types, CDC and CMS
are looking to prevent not only infections within a facility,
but also infections that move across facilities and cause
unnecessary and costly readmissions.
In closing, CDC is focused on building on national progress
and pursuing the elimination of HAIs wherever they are
affecting patients. We know how to protect patients from most
HAIs. These infections can and must be prevented.
Thank you.
[The prepared statement of Dr. Bell follows:]
Prepared Statement of Beth Bell, M.D., M.P.H.
Chairman Harkin, Ranking Member Alexander, members of the
committee, thank you for the opportunity to speak to you today about
CDC's activities to prevent healthcare-associated infections (HAIs).
CDC works 24-7 to save lives and protect people from harm. CDC has
prioritized the prevention of healthcare-associated infections as one
of the agency's Winnable Battles--public health priorities with large-
scale impact on health and with known, effective strategies to address
them.
Before I begin, I want to extend my sympathies to the millions of
patients affected by healthcare-associated infections. No patient
should be harmed by healthcare. We must always remember the patients
who become debilitated and die from these infections, as well as their
families. CDC's ultimate goal is the elimination of healthcare-
associated infections.
The Nation has made significant progress in reducing the incidence
of some HAIs, as reported by CDC this week. Notably, CDC data indicate
that over the last 4 years, central-line associated bloodstream
infections were reduced by 44 percent and surgical-site infections by
20 percent.\1\ Last week, CDC also published new data on dramatic
declines in invasive (life-threatening) MRSA infections. This study
estimated that over 30,000 fewer invasive MRSA infections occurred in
hospital and non-hospital settings in 2011 compared with 2005, and over
9,000 fewer deaths occurred among individuals hospitalized with
MRSA.\2\ The study also showed a 54 percent decline in serious MRSA
infections occurring among hospitalized patients between 2005 and
2011.\3\
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\1\ CDC will be presenting these current numbers at the upcoming
HHS Action Plan meeting on September 26, 2013.
\2\ Antibiotic Resistant Threats in the United States, 2013: http:/
/www.cdc.gov/drugresistance/threat-report-2013/.
\3\ Antibiotic Resistant Threats in the United States, 2013: http:/
/www.cdc.gov/drugresistance/threat-report-2013/.
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CDC has also estimated long-term national declines in CLABSIs. In a
recently released paper, CDC authors estimated that between 1990 and
2010, between 104,000 and 198,000 CLABSIs were prevented among critical
care patients in the United States.\4\ These findings suggest that
technical innovations and dissemination of evidence-based CLABSI
prevention practices recommended by CDC have been effective on a
national scale.
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\4\ CLABSI Vital Signs MMWR: http://www.cdc.gov/mmwr/preview/
mmwrhtml/mm6008a4.
htm?s_cid=mm6008a4_w.
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CDC's portfolio of activities is critical to improving the capacity
of healthcare facilities and States to detect HAIs and protect patients
and communities. We know we must continue and expand on these efforts
and are pleased to have the opportunity to discuss them with you today.
healthcare-associated infections and related antibiotic resistance
Healthcare-associated infections are infections that patients
acquire while receiving care. They include a variety of infections
ranging from those related to specialized intensive care procedures
like mechanical ventilation, to infections caused by lapses in basic
safe practices, like re-using disposable syringes or inappropriate
cleaning of equipment. The most common types of healthcare-associated
infections are central-line associated blood stream infections
(CLABSIs), catheter-associated urinary tract infections (CAUTIs),
surgical-site infections (SSIs), gastrointestinal illnesses like
Clostridium difficile (C. difficile), and pneumonias. HAIs are
associated with increased mortality and greater cost of care, and can
occur in any healthcare setting--hospitals, long-term acute care,
dialysis clinics, ambulatory surgical centers, nursing homes/skilled
nursing facilities, and even doctors' offices. In the worst cases, HAIs
can lead to sepsis, a dangerous body-wide inflammation that can result
in organ failure and death. Primary prevention of HAIs stops a root-
cause of sepsis.
CDC data indicate that approximately 1 in 20 hospitalized patients
develop HAIs and over 1 million infections occur each year across
healthcare settings. In hospitals alone, HAIs result in billions of
dollars of excess healthcare costs and contribute to the deaths of
thousands of patients every year.\5\ HAIs are caused by a wide range of
pathogens. Infections from pathogens resistant to standard antibiotic
treatment are now too common, and some pathogens have even become
resistant to all types or classes of antibiotics. CDC estimates that 1
in 5 HAIs show some form of drug resistance making treatment more
difficult for the patients and frequently more expensive.\6\ Patients
with these resistant infections are more likely to die, and survivors
have significantly longer hospital stays, delayed recuperation, and
more long-term disability. The loss of effective antibiotics can make
even common infections dangerous and undermines our ability to fight
infections and manage the infectious complications common in vulnerable
patients with chronic conditions.
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\5\ The Direct Medical Costs of Healthcare-Associated Infections in
U.S. Hospitals and the Benefits of Prevention: http://www.cdc.gov/HAI/
pdfs/hai/Scott_CostPaper.pdf.
\6\ National Burden of Invasive Methicillin-Resistant
Staphylococcus aureus Infections, United States, 2011.
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Antibiotic resistance is one of our most serious health threats and
one of CDC's most significant concerns related to healthcare-associated
infections. Resistance is not just a problem for the infected patient.
When infections are not cured because they are resistant to the drugs
we use, those infections persist and spread to others. Last week, CDC
released a landmark report that presented a first-ever U.S. snapshot of
the burden and threats posed by the antibiotic-resistant pathogens
having the most impact on human health; these include healthcare-
associated infections.\7\ Two of the three infections prioritized as
urgent in the report are primarily healthcare related--carbapenem-
resistant Enterobacteriaceae (CRE) and C. difficile. CDC's report
describes critical steps needed to address antibiotic resistance,
including: improving antibiotic prescribing, preventing transmission of
infections through infection control and environmental cleaning, and
monitoring the spread of resistant pathogens. The following are just a
few of the most urgent and serious HAI pathogens, affected by
antibiotic resistance and inappropriate antibiotic use:
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\7\ Antibiotic Resistant Threats in the United States, 2013: http:/
/www.cdc.gov/drugresistance/threat-report-2013/.
C. difficile is a life-threatening diarrheal infection
associated with antibiotic use that causes or extends nearly 250,000
hospitalizations and at least 14,000 deaths every year in the United
States and over $1 billion in excess medical costs annually.\8\ \9\ C.
difficile infections can be prevented. Early results from hospital
prevention projects show 20 percent fewer C. difficile infections in
less than 2 years when recommended infection-prevention and control
measures are followed and more than 50 percent fewer infections when
rigorous antibiotic stewardship programs are implemented.\10\
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\8\ CDI Vital Signs: http://www.cdc.gov/VitalSigns/pdf/2012-03-
vitalsigns.pdf.
\9\ CDC will be releasing new estimates on the burden of
Clostridium difficile in the coming months.
\10\ http://www.hpa.org.uk/web/HPAweb&Page&HPAwebAutoListName/
Page/11797452823
88 and J Antimicrob Chemother 2012; 67 Suppl 1: i51-i63.
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CRE are hard-to-treat bacteria that are on the rise among
patients in medical facilities, with over 9,000 estimated cases
nationwide.\11\ CRE have become resistant to all or nearly all the
antibiotics we have today. Almost half of hospital patients who get
bloodstream infections from CRE bacteria die from the infection.\12\ By
following CDC guidelines in the CRE toolkit,\13\ we can halt CRE
infections before they become widespread in hospitals and other medical
facilities.
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\11\ Antibiotic Resistant Threats in the United States, 2013:
http://www.cdc.gov/drug
resistance/threat-report-2013/.
\12\ CRE Vital Signs: http://www.cdc.gov/VitalSigns/pdf/2013-03-
vitalsigns.pdf.
\13\ CRE Toolkit: http://www.cdc.gov/hai/organisms/cre/cre-toolkit/
index.html.
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Extended-spectrum penicillin and cephalosporin-resistant
Enterobac-
teriaceae cause nearly 26,000 (or 19 percent) of healthcare-associated
Enterobac-
teriaceae infections.\14\ Patients with bloodstream infections caused
by an ESBL-containing Enterobacteriaceae are about 57 percent more
likely to die than those with bloodstream infections caused by a
nonESBL-containing strain.\15\ ESBL bacteria are the predecessors to
CRE and can also be prevented by following the CDC guidelines in the
CRE toolkit.
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\14\ Antibiotic Resistant Threats in the United States, 2013:
http://www.cdc.gov/drug
resistance/threat-report-2013/.
\15\ Antibiotic Resistant Threats in the United States, 2013:
http://www.cdc.gov/drug
resistance/threat-report-2013/.
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Pseudomonas aeruginosa causes an estimated 51,000
healthcare-associated infections in the United States each year. More
than 6,000 (or 13 percent) of these are multidrug-resistant, meaning
that several classes of antibiotics no longer cure these
infections.\16\ Infection-control and appropriate use of contact
precautions are important for the prevention of Pseudomonas aeruginosa.
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\16\ Antibiotic Resistant Threats in the United States, 2013:
http://www.cdc.gov/drug
resistance/threat-report-2013/.
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Vancomycin-resistant Enterococci (VRE) are resistant to
vancomycin, an antibiotic of last resort, leaving few or no treatment
options among very sick patients in hospitals and other healthcare
settings. Approximately 20,000 (or 30 percent) of the healthcare-
associated infections caused by Enterococcus each year are vancomycin-
resistant.\17\ Appropriate use of contact precautions and effective
environmental cleaning reduces the transmission of VRE.
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\17\ Antibiotic Resistant Threats in the United States, 2013;
http://www.cdc.gov/drug
resistance/threat-report-2013/.
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Methicillin-resistant Staphylococcus aureus (MRSA) remains
one of the most common causes of healthcare-associated infections
despite significant progress in its prevention across healthcare
settings.\18\ Recent studies have shown that the use of a pathogen-
killing soap and nasal ointment can potentially further prevent the
spread of MRSA.
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\18\ National Burden of Invasive Methicillin-Resistant
Staphylococcus aureus Infections, United States, 2011.
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Acinetobacter is a type of gram-negative bacteria that is
a cause of pneumonia or bloodstream infections among critically ill
patients. About 63 percent of Acinetobacter is considered multidrug-
resistant, meaning at least three different classes of antibiotics no
longer cure Acinetobacter infections.\19\ Appropriate use of contact
precautions and effective environmental cleaning reduces the
transmission of VRE.
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\19\ Antibiotic Resistant Threats in the United States, 2013:
http://www.cdc.gov/drug
resistance/threat-report-2013/.
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Candida is a fungal pathogen that is the fourth most
common cause of healthcare-associated bloodstream infections in the
United States.\20\ In some hospitals it is the most common cause. Some
Candida strains are increasingly resistant to first-line and second-
line antifungal treatment agents. Appropriate stewardship for
antifungal medications reduces the development of Candida resistance.
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\20\ Antibiotic Resistant Threats in the United States, 2013:
http://www.cdc.gov/drug
resistance/threat-report-2013/.
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recent successes & cdc's detect and protect portfolio
Despite the significant burden of HAIs in the United States and the
growth of antibiotic resistant pathogens, most HAIs are preventable.
Many of the recent HAI prevention successes reflect activities
identified in the National Action Plan for the Prevention of Health
Care Associated Infections which was developed under the coordination
of the HHS Office of the Assistant Secretary. These include innovations
in tracking HAIs and drug resistant pathogens and targeting problem
areas with effective prevention strategies. CDC, working with CMS,
AHRQ, and other agencies in the U.S. Department of Health and Human
Services (HHS), has taken a lead role in addressing the important
public health challenge by implementing strategies to detect HAIs and
protect patients from them.
In an analysis currently undergoing peer review, CDC experts
performed an historical economic model to measure the net economic
benefits of preventing CLABSIs in Medicare and Medicaid patients in
critical care units from 1990 to 2008 using the cost perspective of the
Federal Government as a third party payer. The estimated net economic
benefits ranged from $756 million to $1.9 billion with the
corresponding net benefits per case averted ranging from $16,550 to
$24,060.\21\ The per-dollar rate of return on CDC investments ranged
from $4.54 to $23.45.\22\
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\21\ Pending publication, unpublished data currently under peer
review.
\22\ Pending publication, unpublished data currently under peer
review.
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Using multiple detect-and-protect strategies, CDC's world-class
experts target HAIs and the drug resistant pathogens that can cause
them, including:
monitoring HAIs and evaluating their risk factors,
establishing benchmarks and targets, and tracking prevention progress
toward those goals;
detecting and responding to emerging and urgent threats
through outbreak investigation and laboratory science;
developing guidelines for HAI prevention and filling gaps
in knowledge through applied research;
implementing prevention strategies with Federal and State
partners.
tracking hais and hai prevention progress
CDC's National Healthcare Safety Network (NHSN) is the Nation's
most widely used healthcare-associated infection tracking system. NHSN
provides facilities,\23\ States, regions, Federal partners such as the
Centers for Medicare & Medicaid Services (CMS), and the Nation with
data needed to identify problem areas, measure progress of prevention
efforts, and ultimately eliminate healthcare-associated infections.
NHSN currently serves more than 12,000 medical facilities tracking
HAIs.\24\ Participation is expected to continue to grow.
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\23\ Current participants include acute care hospitals, long-term
acute care hospitals, psychiatric hospitals, rehabilitation hospitals,
outpatient dialysis centers, ambulatory surgery centers, and nursing
homes, with hospitals and dialysis facilities representing the majority
of facilities reporting data.
\24\ NHSN: http://www.cdc.gov/nhsn/about.html.
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CDC provides the standard national measures for HAIs as well as
analytic tools that enable each facility to assess its progress and
identify where additional efforts are needed. While ensuring data
security, integrity, and confidentiality, NHSN gives healthcare
facilities the ability to see their data in real-time and share that
information with clinicians and facility leadership, as well as with
other facilities (e.g., a multihospital system) and partners such as
State and local health departments or CMS quality improvement
organizations. To limit burden on facilities and leverage efficiencies
across government, NHSN serves as the conduit for facilities to comply
with CMS infection reporting requirements (see figure 1). NHSN data are
analyzed by CDC and others to direct actions for HAI prevention. Local,
State, and national HAI trends are used to identify problems and areas
of concern that need intervention, and to measure progress in HAI
reduction against national, State, and local prevention goals.
NHSN provides facilities with data collection and reporting
capabilities needed to:
identify infection prevention problems \25\;
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\25\ In addition, NHSN allows healthcare facilities to track blood
safety errors, antibiotic use, and important healthcare process
measures such as healthcare personnel influenza vaccine status and
infection control adherence rates.
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benchmark progress of infection prevention efforts;
comply with State and Federal public-reporting mandates,
and;
ultimately drive national progress toward elimination of
HAIs.
Patients can use NHSN data posted publicly on HHS's Hospital
Compare Web site.\26\ Patients are encouraged to visit the Web site to
see how their local facilities are doing and discuss concerns with
their healthcare providers.
---------------------------------------------------------------------------
\26\ http://www.medicare.gov/hospitalcompare.
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To understand patterns of infections and how drug resistant-
pathogens move through communities, and to build the evidence base of
best practices to prevent spread, CDC relies upon its Emerging
Infections Program (EIP).\27\ The 10-State EIP network consists of
partnerships between State health departments and university
collaborators that provide critical evaluation of the epidemiology and
public health impact of HAIs, the burden of emerging drug-resistant
infections, and identification of new populations-at-risk for
healthcare-associated infections. The EIP is currently working on new
estimates of the overall burden of HAIs nationwide and providing
updated information on the most commonly used antimicrobials and
treatment indications. The network has begun plans to perform a large
scale assessment of antibiotic use appropriateness and to test what
interventions can be used to improve antibiotic prescribing and thereby
reduce drug resistance and improve patient outcomes.
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\27\ EIP-HAI projects: http://www.cdc.gov/hai/eip/.
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The National Action Plan to Prevent Health Care-Associated
Infections: Road Map to Elimination (National Action Plan), developed
under the leadership of the Office of the Assistant Secretary, sets
specific targets based on NHSN, EIP, and other data systems for
monitoring and preventing HAIs nationally and represents a national
blueprint for promoting HAI prevention.\28\ CDC has collaborated
closely with HHS's Assistant Secretary for Health, the Agency for
Healthcare Research and Quality (AHRQ), CMS, and other Federal agencies
to implement the National Action Plan and expand its impact to
additional healthcare settings.
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\28\ National Action Plan to Prevent Health Care-Associated
Infections: Road Map to Elimination: http://www.hhs.gov/ash/
initiatives/hai/actionplan/index.html.
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outbreak investigation and response and laboratory science
CDC serves as a national and global leader in the investigation and
control of HAI outbreaks. On a daily basis, CDC responds to inquiries
from facilities and States about unexplained illness and/or death
related to product, device, or environmental contamination and lapses
in basic infection control or injection safety. CDC deploys experts
including healthcare epidemiologists, infectious disease physicians,
and laboratory scientists to assess healthcare settings, collect and
analyze data, evaluate practices, and perform microbiologic testing in
response to a newly recognized outbreak or problem. Through its
investigations, CDC identifies and controls problems, develops new
prevention strategies, and works with partner agencies such as CMS and
the Food and Drug Administration (FDA) to implement policy changes.
Some of our Nation's most significant healthcare problems are first
identified through outbreak investigations conducted by CDC and its
State partners, including last year's nationwide response to an
outbreak of fungal meningitis and other infections related to a
compounded medication associated with the New England Compounding
Center (NECC). With 750 cases and 64 deaths reported to CDC to date,
affected patients continue to suffer from these infections and the
burden of treating them.
Outbreaks demonstrate the essential role that public health plays
in keeping our country safe from infectious disease threats. Our
national public health capacity is disseminated to State and local
responders who work in partnership with CDC. Outbreak responses require
skilled, trained public health personnel in State and local agencies
capable of responding to outbreaks in a range of healthcare settings
including hospitals, nursing homes, dialysis facilities, and doctor's
offices. CDC support to State infectious disease programs is critical
to local outbreak response capacity.
Outbreaks also highlight the importance of CDC's infectious disease
laboratories to rapidly respond to and characterize unexplained death
and illness. CDC has multiple laboratories that provide outbreak
response capacity for HAIs. CDC's drug-
susceptibility laboratory serves as a World Health Organization (WHO)
collaborating center for antibiotic resistance, providing worldwide
reference capacity, conducting strain typing and additional molecular
characterization of antibiotic resistant pathogens, and detecting novel
and emerging antibiotic resistance in health care-associated bacteria.
CDC's environmental microbiology laboratory maintains unique capacities
to sample environments to identify contamination, determine routes of
transmission, and isolate the cause of outbreaks of unknown etiology.
Advances in laboratory technologies such as high-throughput genome
sequencing, along with improved capabilities in the field of
bioinformatics, stand to revolutionize our ability to control
infectious diseases including HAIs, enabling faster, more accurate, and
cost-effective ways of preventing, detecting, and responding to known,
emerging, and resistant pathogens. To help CDC gain the capacity to
keep pace with this rapidly changing field, the President's fiscal year
2014 Budget proposes an Advanced Molecular Detection initiative \29\
that would equip CDC's scientists and laboratories with two powerful
technologies--molecular sequencing and bioinfor-
matics--to help solve complex disease mysteries. Modernizing CDC's
infectious disease laboratories and building its bioinformatics
capacities are essential to ensure that the expanding use of these new
technologies brings strong benefits for public health. With these new
tools, disease detectives can solve more health mysteries and solve
them faster.
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\29\ http://www.cdc.gov/amd/.
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guidelines for prevention and researching gaps in knowledge
Information CDC learns from outbreaks not only serves to control
the immediate problem, but also has a direct impact on future HAI
prevention nationwide. Experience from outbreak investigations
contributes to refinement of infection control guidelines and
improvements in HAI tracking. CDC, working with the Healthcare
Infection Control Practices Advisory Committee (HICPAC), develops
evidence-based guidelines for HAI prevention. CDC's infection control
guidelines set the standard of care for HAI prevention in the United
States and are the basis of HAI prevention checklists.
CDC's experts also work to improve upon HAI prevention guidelines
by filling critical gaps in knowledge. Through a cooperative agreement,
CDC works with a network of academic partners, called the Prevention
Epicenters, to address gaps in the evidence base related to the
prevention of HAIs, antibiotic resistance, and other adverse events
associated with healthcare. This unique forum enables academic leaders
in healthcare epidemiology to partner directly with each other and with
CDC experts to conduct innovative research designed to fill knowledge
gaps that are most important to public health. Because the Prevention
Epicenters work together, there is an emphasis on multicenter
collaborative research projects, many of which would not be possible
for a single academic center.
For example, the recent REDUCE MRSA Trial,\30\ a collaboration of
CDC, its network of Prevention Epicenters, and AHRQ, tested three MRSA-
prevention strategies. The study results found compelling evidence that
one of the interventions--the use of a pathogen-killing soap and nasal
ointment on all intensive-care unit (ICU) patients--reduced bloodstream
infections by up to 44 percent and significantly reduced the presence
of MRSA and other pathogens in ICUs. A total of 74 adult ICUs and
74,256 patients were part of the study, making it the largest study on
this topic and we believe that the results are already impacting
practice and improving care in hospitals across the country.
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\30\ http://www.nejm.org/doi/pdf/10.1056/NEJMoa1207290.
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implementing prevention strategies with federal and state partners
NHSN and CDC HAI prevention guidelines are used by all Federal
agencies working on HAI prevention and are the basis for most State HAI
prevention initiatives. CDC's NHSN data is used to measure the progress
of the HHS Partnership for Patients initiative, for AHRQ's
Comprehensive Unit-Based Safety Program, and to support targeted
prevention activities for CMS Quality Improvement Organizations. CDC
also develops tools to translate what we know works to prevent HAIs
(CDC and HICPAC guidelines) into practice.\31\ For example, CDC is
improving basic infection control practices through collaborations with
CMS to expand survey and oversight capacity of non-acute healthcare
settings. CDC and CMS worked together to develop a new tool that State
inspectors are using to ensure the quality of care in ambulatory
surgical centers (ASCs).\32\ CDC is working with CMS to expand
incorporation of basic infection control content into CMS interpretive
guidance for their conditions of coverage for outpatient settings. CDC
continues to work with CMS to develop similar tools for use in acute
care and other healthcare settings. CDC also develops tools to help
facilities prevent the spread of drug resistant infections. In 2012,
CDC released the CRE Toolkit \33\ to provide education for doctors and
nurses, hospitals, long-term acute care hospitals, nursing homes, and
health departments. It gives step-by-step instructions for facilities
treating patients with CRE infections and for those not yet affected by
it.
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\31\ CDC HICPAC Guidelines: http://www.cdc.gov/hicpac/.
\32\ In a 2008 Federal survey of ASCs, 68 percent of 68 surveyed
centers had noncompliance with the infection-control requirements in
the Medicare ASC health and safety standards. CMS has found infection-
control problems in ASCs to be both common and egregious, ranging from
failure to clean equipment between patients and re-use of single-dose
vials of medication for multiple patients.
\33\ CRE Toolkit: http://www.cdc.gov/hai/organisms/cre/cre-toolkit/
index.html.
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Through funding under the Prevention and Public Health Fund, CDC
also supports HAI coordinators \34\ at all 50 State health departments.
These coordinators use data from CDC's National Healthcare Safety
Network to help target HAI prevention efforts locally, leveraging
ongoing HAI projects and collaborating with local partners to avoid
duplication. For example, the HAI coordinator at the Tennessee State
Health Department collaborated with the local quality improvement
organization (QIO) supported by CMS to target C. difficile prevention.
This collaboration leveraged the complementary expertise of the
organizations: the QIO recruited a group of interested and motivated
facilities and is providing them with support on performance
improvement, while the Tennessee State Health Department has provided
those facilities with specific training on how to prevent and monitor
C. difficile infections. The Tennessee State Health Department is also
analyzing data on C. difficile infections being submitted to the CDC's
NHSN to help both the facilities and the QIO monitor their progress and
drive quality improvement.
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\34\ HAI coordinators were recently named White House Champions for
Change: Marion Kainer (TN) and Erica Washington (LA): http://
www.whitehouse.gov/champions.
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future directions
In moving HAI prevention forward, CDC is focused on making progress
wherever HAIs are impacting patients. Drug-resistant HAIs and C.
difficile continue to take a toll on patients nationwide and must be
addressed. To accelerate improvement, CMS began requiring the reporting
of C. difficile infections through CDC's NHSN last year. CDC is
launching a new component of NHSN, developed with CMS and others, that
will electronically measure, benchmark, and help facilities improve
antibiotic use--a leading driver of both drug resistance and C.
difficile infections. CDC is testing new interventions such as
antibiotic timeouts and antibiotic stewardship protocols that we hope
can make real contributions to prevention progress. With our State
partners, CDC is also piloting regional ``detect and protect''
collaboratives that are focused on preventing drug-resistant HAIs
across communities by ensuring that hospitals, long-term acute care
facilities, and nursing homes/skilled nursing facilities work
cooperatively to limit the spread of dangerous pathogens within and
across those facilities.\35\
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\35\ Detect and Protect: http://www.cdc.gov/hai/pdfs/cre/
CDC_DetectProtect.pdf.
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For the prevention of CLABSIs, CDC is working with CMS to ensure
that the prevention gains we have seen thus far in hospital intensive
care units are carried over to general hospital wards, long-term acute
care, and dialysis settings. CDC and CMS are also working to make
improvements in the surveillance and prevention of catheter-associated
urinary tract infections (CAUTI), which have increased over the past 2
years. CDC is refining the measurement and prevention science for HAI-
related pneumonias and surgical-site infections, which represent a
significant HAI burden. For all of these infection types, CDC and CMS
are looking to prevent not only infections within a facility but also
infections that move across facilities and cause unnecessary, costly
readmissions.
conclusion
Ensuring that appropriate infection control and antibiotic use
practices are adhered to in all healthcare settings is a priority for
CDC. Public health plays a pivotal role in ensuring a unified and
integrated approach through systematic implementation of prevention
practices, monitoring to detect problems, outbreak investigation and
control, oversight, education, and research. Our work in HAI prevention
illustrates the power of public health in action both to detect serious
health problems and to lead State and Federal partners to implement
targeted responses that will protect our Nation and its citizens from
infectious disease threats. As we continue to work toward elimination
of HAIs, new healthcare settings and changing technology will create
new challenges and will require fast detection and innovative responses
to prevent harm to the public. CDC continues to address challenges as
they arise and ensure that patients are safe in every healthcare
setting. We know how to protect patients from most HAIs; these
infections can and must be prevented.
Figure 1: Participation in CDC's National Healthcare Safety Network (NHSN) for CMS Value-Based Purchasing
----------------------------------------------------------------------------------------------------------------
Location HAI Event Reporting Start Date CMS Reporting Program
----------------------------------------------------------------------------------------------------------------
Acute Care Hospitals................. CLABSI--ICU............ 11-Jan................. Hospital Inpatient
CAUTI--ICU............. 12-Jan................. Quality Reporting
SSI (COLO and HYST).... 12-Jan................. Program.
MRSA Bacteremia........ 13-Jan.................
C. difficile LabID 13-Jan.................
Event.
Dialysis Facilities.................. I.V. antimicrobial 12-Jan................. ESRD Quality Incentive
start, Positive blood Program.
culture, Signs of
vascular access
infection.
Long-Term Acute Care Facilities CLABSI, CAUTI.......... 12-Oct................. Long Term Care Hospital
(LTAC). Quality Reporting
Program.
Inpatient Rehabilitation Facilities CAUTI.................. 12-Oct................. IRF Quality Reporting
(IRF). Program.
Ambulatory Surgical Centers (ASC).... None at this time...... 13-Oct................. ASC Quality Reporting
Program.
Nursing Homes/Skilled Nursing None at this time...... n/a.................... None at this time.
Facilities \1\.
All Facilities....................... HCW Influenza 14-Oct \2\............. All Reporting Programs
Vaccination. \2\
----------------------------------------------------------------------------------------------------------------
\1\ No information on proposed reporting in long-term care/skilled nursing, but CDC's LTC component made
available for use in August 2012.
\2\ Acute Care Hospitals began reporting HCW Influenza Vaccination January 2013 as part of Hospital Inpatient
Quality Reporting Program; all other facility types to begin in October 2014.
The Chairman. Thank you very much, Dr. Bell.
Thank you both. We'll start a round of 5-minute questions,
and due to the time element, I will try to adhere as strictly
as I can to that 5 minutes.
Dr. Conway, one of the most common features of successful
initiatives to reduce infection rates is cooperation and
coordination across providers. How can the Federal Government
create incentives, financial or otherwise, for healthcare
providers who are often competitors to work together to advance
patients' interests?
Again, a lot of this is in software programs. One hospital
has one set of software, and another hospital has another
software program. People go from one hospital to the other, and
nobody talks to one another because these are proprietary,
don't you know, and these two are competitors. How do we break
that down? How do we provide for that kind of transparency that
you mentioned and coordination, given that kind of a set up?
Dr. Conway. Thank you for the question, Senator Harkin.
I'll answer it directly for HAIs and then the broader
coordination, if that's OK.
Speaking directly to infections and safety issues, we have
measures of the system of care, really focusing on that shared
accountability with strong measurement systems working with our
colleagues at CDC--for things like bloodstream infections,
urinary tract infections, surgical site infections, really
focusing not on the individual provider but the system of care
and how we can coordinate, use team-based care and improvement
methods to successfully decrease those infections.
On the broader issue of sharing information and
coordination of care, one, we're trying to measure transparency
for things like the readmissions program and also include both
payment incentives, so a potential for negative payment
adjustments, as well as quality improvement in the field to
coordinate care. So we're investing, through Partnership for
Patients, our QIO program, and community-based care transitions
program, millions of dollars in communities to link providers
together to coordinate care so beneficiaries receive
coordinated care and stay home and healthy.
Last, in the meaningful use in technology arena, we'll
continue to push forward on interoperability and sharing of
information, really empowering patients and consumers with
information and incentivizing sharing of information to best
coordinate care.
The Chairman. And you can do that across competitors'
lines?
Dr. Conway. There's a couple of ways we try to address that
issue. One is with our incentive programs and also new models
that we're testing, such as accountable care organizations,
really incentivizing better coordinated care, higher quality at
lower cost, and really incentivizing providers to work together
to coordinate care. We have our Medicare Shared Savings Program
and then our pioneer ACOs and advanced care payment ACOs out of
the Innovation Center. Those are examples of payment models.
We're launching a bundle payment initiative, which will
incentivize care coordination both within the hospital to post
acute care settings and into the community. So we have a number
of interventions and models that we're testing to better
coordinate care for populations of patients.
The Chairman. Thank you.
Dr. Bell, could you specifically address the issue of
sepsis and CDC's work on infections and whether it has any
affect on the rates of sepsis? We hear about other things. But
how about sepsis--we're going to hear more about that in the
second panel--or MRSA, the two that perhaps frighten people the
most? Could you address both of those, in particular?
Dr. Bell. Thank you, Senator. Sepsis is a terrible
condition that causes a lot of tragedy and suffering.
Healthcare-associated infections are one of the root causes of
sepsis. So the way someone dies, let's say, of a central line
infection is by sepsis. So by preventing healthcare-associated
infections, we are making a contribution to preventing sepsis.
There clearly is a lot more that needs to be done in terms
of improving communication, linkage to care, and these are all
areas that we're continuing to work on with our colleagues at
CMS to make additional progress. But, as I say, the more we
drive toward reducing healthcare-associated infections, the
more we reduce one of the root causes of sepsis.
In terms of MRSA, we do have a little bit of good news
about MRSA. As I mentioned, last week, we reported on trends in
MRSA and actually found a 54 percent decline in MRSA infections
in hospitalized patients and also declines in community-
acquired MRSA and MRSA probably acquired in the hospital but
manifested in the community.
This is an area where we are making some progress. We have
a lot further to go. But it is an example of where, by using
CDC guidelines, by tracking effectively so that we provide
feedback to providers and to hospitals and to patients about
progress and the incidence of these infections, we really can
actually have a measurable impact.
The Chairman. Thank you both very much.
Senator Alexander.
Senator Alexander. Dr. Bell, is it CDC's, Centers for
Disease Control's, statistic that about 1 out of 20 people who
go into a hospital gets an infection while there?
Dr. Bell. Yes, sir.
Senator Alexander. What was it 10 or 20 or 30 years ago?
Was it better or worse?
Dr. Bell. There were more infections 10 or 20 years ago
than there are now. And, in fact, we're in the process of
updating our estimates at the moment, and we're hoping,
actually, that that 1 in 20, we'll be able to say, is less,
maybe 1 in 25. I don't know.
We've definitely made progress in many areas, central line
infections, for example. In the early 2000s, we were seeing
40,000 infections a year, and this last year, we saw 12,000
central line infections. So there's no doubt that there's been
progress in some areas.
But in other areas, we're not seeing the progress we'd like
to see. For example, as you noted, we're very concerned about
resistant infections and about C. difficile. These are areas
where we haven't made progress, and, in fact, in some
situations, it seems like we're going backward.
Senator Alexander. Well, I was going to ask that. You've
made some progress in the number of infections, and I guess
progress has been made in detecting infections. Is that
correct, too? Are people more aware of it now?
Dr. Bell. Yes, certainly for some infections. But, again,
that's an area, I think, where we really have a lot of room for
improvements. Certainly, a number of outbreaks that we've
investigated recently--one of the lessons from those outbreaks
is the difficulty that hospitals and laboratories have in
detecting, especially, some of these resistant pathogens. And
that's an area where there really is room for improvement.
Senator Alexander. Now, the resistant pathogens--this
sounds like the work in HIV 10 or 15 years ago, where the
medicines that were developed for it were--after a while, they
didn't work because the immune system got used to them, I
guess. Is the ability to develop medicines that deal with these
bacteria getting more difficult? Why are we going backward in
that, if we are?
Dr. Bell. Well, unfortunately, bacteria will always develop
resistance. They're very clever organisms. They pass these----
Senator Alexander. But hasn't that always been the case?
Dr. Bell. Yes, it has. But a number of factors have
selected for some of these organisms that have developed
resistance to more and more antibiotics. One of the reasons for
that, we think, is overuse of antibiotics, and there are many
estimates out there that half of the antibiotics that are used
in the United States are unnecessary. So for that reason and
for many other reasons, we are seeing this class of bacteria
that are becoming resistant to more and more antibiotics.
In our report that we published last week, we identified
four areas, four things that need to be done to fight
antimicrobial resistance. One of them is to prevent resistant
infections. A second is to track them, as you mentioned,
Senator, in terms of detection. A third is to improve
antimicrobial use. And the fourth is to promote development of
new drugs and new diagnostics.
Senator Alexander. By improving the use, you mean don't use
antibiotics more than necessary because it makes them less
useful in combating these bacteria.
Dr. Bell. That's correct.
Senator Alexander. What about the success, or lack of it,
of Generating Antibiotic Incentives Now? Congress tried to
respond to this last year. Has that been helpful?
Dr. Bell. Yes, sir. I think we've certainly been working
with FDA on certain components of the GAIN Act. One of the
first things that FDA did was to generate a list of the
bacteria and other organisms that would be covered under the
GAIN Act. We collaborated with them, and I think the list that
the FDA has generated will provide a focus for industry to work
on developing new drugs.
Senator Alexander. In the first year of its use, have you
found any changes that need to be made in it?
Dr. Bell. I think this issue of developing new antibiotics
is a very long-term proposition, and that's one of the reasons
why some of the other things that we're calling for to prevent
resistance are so important in terms of improving use and
prevention and tracking.
Senator Alexander. Sometimes we have in our country great
health crusades to try to eradicate a problem, for example,
with polio. Is this a case where we should have as an objective
eradicating infections acquired when you go into a healthcare
facility? And if that is a goal, is it a realistic goal?
Dr. Bell. Well, Senator, we've said that that's our goal.
And I think we can all agree, as patients, potentially,
ourselves, as children or parents of patients, that it's not
right, as you said, Senator, to go to the hospital to get cured
and instead get an infection that could kill you.
So we have said that our goal is to eliminate HAIs, and I
think that this is something that we all can unite on. I mean,
no doctor wants to give their patient a healthcare-associated
infection, either. Whether we can get down to zero HAIs, I
don't know. But we certainly have a long way to go. There's
much, much improvement that we can make as we drive toward that
as a goal.
Senator Alexander. Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Alexander.
In order, I have Senator Whitehouse, Senator Isakson,
Senator Murphy, Senator Burr, Senator Casey, Senator Baldwin.
Again, the clock is wrong. It's 10:36 right now. That clock is
15 minutes fast. But I remind everyone that we are still facing
a vote at 11:45, and we have a very good panel that I'd like to
followup with on this. So if you'd keep it short, I'd sure
appreciate it.
Senator Whitehouse.
Statement of Senator Whitehouse
Senator Whitehouse. Thank you, Chairman. Thank you for
holding this hearing. This is such an important subject. In
Rhode Island, we have a group called the Rhode Island Quality
Institute that has been working--you know it. I see the heads
nodding.
Years ago, we took the Pronovost principles, the Keystone
Project, and we went statewide in every ICU in Rhode Island.
Every hospital participated. We're down more than 60 percent on
central line-related infections. We're down nearly half on
ventilator-associated infections, and we're running about one
infection per 1,000 patient days, which I think is a lot better
than the one in 20 that our Ranking Member referred to. We
started in a good place with very good hospitals in Rhode
Island, very good ICU care, and improved by applying those
principles.
However, over the years of doing that, it was not CMS
supported. It was a purely local initiative. Some of the things
that you've referred to help create an environment where, for
hospitals and for insurance companies, it makes sense to get
engaged in this kind of activity.
But I would urge you to be more energetic about looking for
ways to support these local initiatives, because it really is
pulling the different hospitals, the different hospital
systems, the different information systems together that makes
it happen. And making that happen isn't easy for States that
are strapped, and I think the return on that investment is
huge. So I would urge you to do that.
I can't resist saying this when people who are in this
Administration come. But, first of all, thank you for not
saying ``bending the healthcare cost curve.'' That is my least
favorite expression, because it is a metric that has no
accountability to it.
It's very frustrating when the hope for delivery system
reform, the prospects for healthcare delivery system reform,
the ability to take--burning 18 percent of GDP on healthcare
and reduce it to more like 12 percent, where every other
industrialized nation is--the Institutes of Medicine, the Rand
Corporation, the President's Council of Economic Advisors,
everybody is saying there's $700 billion or $800 billion a year
to be saved by delivering better healthcare.
I would really, really like to see this Administration put
out a savings target, not something vague, like we're going to
bend the healthcare cost curve, but by this date, we're going
to save this much money by improving the quality of care. I
think that drives a message through all of the Federal
bureaucracy to gear up.
I think that if President Kennedy had said we're going to
bend the curve of space exploration, we never would have put a
man on the moon. It's because a hard target was set, and all of
the forces of this very capable country were focused on meeting
that target. And until we have such a target, I think we're
going to continue to be operating at less than our full
capability. When you consider the lives that are at stake here
and the savings that are at stake here, I think operating at
anything less than full capacity is a real tragedy.
Those are my two thoughts--if you could find ways to help
these local initiatives more, and thank you for not saying
``bending the healthcare cost curve.'' But at least that's a
first step. But now the real step is to push this
Administration to produce a hard target with a date and a
number.
Go ahead and respond, Dr. Conway. That was not really
framed as a question, but I do want your response.
Dr. Conway. I'll be very brief. One, I can't agree with you
more about the importance of local quality improvement. Quality
improvement happens locally. It happens on the ground with
clinicians and patients in States and communities. So I can't
agree more.
On the concept of setting a target, thank you for your
leadership in this area and for your comments. And on the HAI
point, as an example, we've set the target of 40 percent
reduction, and specific targets by every infection--and Dr.
Bell may speak more to that--but certainly built on the concept
of setting a target and aligning levers to go for that target.
Dr. Bell. Thank you, Senator. You kind of embodied a lot of
our mantras about the important components of preventing
healthcare-associated infections. And just to amplify a little
bit on what Dr. Conway said, I think your point, first of all,
about measurement is very important. This is what the National
Healthcare Safety Network is for.
There are over 12,000 hospitals that participate in the
National Healthcare Safety Network, 12,000 institutions
including 5,500 hospitals. And in each of those hospitals, they
have real-time access to their own data so that they can
actually see where there are problems and drive quality
improvements.
At the same time, because infections don't happen just in
one institution and are spread around in the community, the
State health departments can look at these data, QIOs can look
at these data, hospital engagement networks can look at these
data, and we at CDC look at the data. And we provide benchmarks
so that hospitals and States can determine where they are and
figure out where the areas are where there needs to be
improvement.
There are many examples, including examples in Rhode
Island, in Tennessee, and a number of other States, where State
health departments and QIOs have worked together. When they see
a problem, they go into that institution and figure out how to
fix it.
Senator Whitehouse. Thank you, Chairman.
The Chairman. Thank you very much, Senator Whitehouse.
Senator Isakson.
Statement of Senator Isakson
Senator Isakson. Thank you, Mr. Chairman. I want to
personally thank you, because 3\1/2\ years ago, I was
hospitalized for a week with MRSA. And that's one of the
primary reasons I worked so hard on the GAIN Act, and I
appreciate very much the attention to this. It is a huge issue
and a devastating problem for many families.
Dr. Conway, to that end, when I worked on the GAIN Act, I
wanted to do anything I could do to promote breakthrough
antibiotics to deal with these infections that are so
resistant. I have a concern that under the hospital inpatient
patient system, bundled payments are often determined by the
cost of existing antibiotics that are used and don't take into
consideration the cost of the development of the breakthrough
antibiotics, which will be used rarely, but when used will
actually save an otherwise life threatening infection.
Is there any way CMS can work with the system of
reimbursement to recognize the tremendous cost of a
breakthrough drug when it's introduced and accommodate for
that?
Dr. Conway. Thank you for the question. We work closely
with our payment colleagues on the payment systems in terms of
payments and making sure we pay appropriately, including pay
for new innovations. And Dr. Bell may speak more about the act.
Specifically, on the bundles, we are currently in the
process of setting up that test. It's gone live in phase one.
Phase two, which actually includes the bundles and the bundled
payment care initiative and potential payment adjustments, will
go live in October. We have had a back-and-forth with hospitals
to make sure if there's, for example, truly cases that are
unique or different or technologies that need to be used, how
we can account for that.
So I will take this back to the team as well as an issue to
make sure we're thinking about it and accounting for it as best
as possible.
Senator Isakson. I appreciate your doing so, because the
last thing we'd want to do would be to have a disincentive for
the development of the very drugs we're trying to promote being
developed.
Dr. Bell, I know the focus on this is hospitalization.
First of all, as a Georgian, thank you for you and Dr. Frieden
and the thousands of professionals out on Clifton Road that are
the world's health center. We appreciate all the good work that
you do.
I know we're focusing on in-hospital infections. But I want
to direct a question to you about non-in-hospital infections.
I've introduced legislation for reimbursement for diabetic
patients for needle destruction devices for their home, because
they use hypodermic needles to administer insulin and their
drugs all the time.
I know there are unintended consequences of infections that
are contracted at home or in settings not in the hospital from
needle sticks. Do you think that non-institutional needle stick
infections are a big problem in this country?
Dr. Bell. Thank you, Senator, and thank you for the kind
words. We certainly agree that while we've made progress in
hospital settings and especially in intensive care units, out-
of-hospital settings, including, for example, ambulatory
surgical centers, long-term acute care facilities, are really
places where we need to make a lot more progress. And we
certainly have many examples of where infections are
transferred around from one institution to another, and the
problem is amplified.
Needle sticks are obviously one way that pathogens can be
transmitted. And, as you say, it's in these sort of not as well
controlled settings, like nursing homes, which is another
example where we see outbreaks associated with needle sticks or
unsafe injection practices.
So I agree with you that this is a major problem, what's
happening outside of the hospitals. This is sort of our area of
focus, and we've been working with CMS to try to kind of extend
some of the successes that we've found in a hospital to other
settings.
Senator Isakson. We received an estimate from a major
healthcare carrier in the country that $175 million in costs
every year, annually, are for non-institutional needle stick
infections that are contracted because of reuse of needles or
pricks by needles or things like that. Maybe we can talk to
Director Tavenner and Dr. Conway and take a look at the
reimbursement formula you currently have, because I think the
agency can make the determination itself as to whether the cost
benefit makes sense to reimburse for diabetics in terms of
needle destruction devices.
And I would appreciate hearing from you, if you'd take a
look at that, Dr. Conway.
Dr. Conway. Yes, sir. We'd be happy to take a look at that
and get back with you on the record.
Senator Isakson. Thanks for what both of you do for
healthcare. Thank you.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Isakson.
Senator Murphy.
Statement of Senator Murphy
Senator Murphy. Thank you very much, Mr. Chairman. Thank
you for convening this hearing.
Thank you to both of our witnesses for the great work that
you do.
I just want to first associate myself with the remarks of
Senator Whitehouse. I think it's time to put some real meat on
the bones with respect to setting some cost targets here,
frankly, as we try to pursue a pretty painful conversation
about entitlement reform. One of the few places within that
discussion that we're going to be able to find bipartisan
agreement is in our mutual interest in trying to put some real
numbers around what delivery system reform can deliver in terms
of dollar savings. So I think that's a very useful exercise
with respect to setting a target.
My first question is probably directed to you, Dr. Conway.
These are some pretty impressive numbers in terms of the
reductions that we've seen, whether we're talking about
surgical site infections or central line associated infections.
And I don't think it's a coincidence that it comes on the heels
of a pretty dramatic payment reform instituted in 2008, in
which CMS basically said to hospitals,
``We're going to stop paying you for these
infections. We'll obviously take care of you up until
that point, but that's going to be on your dime.''
I remember when that change was made. There were a lot of
hospitals in Connecticut, even though we were a little bit
ahead of the curve on this, that were worried about the
fairness of that change, because their contention was that,
``We certainly know we can control a lot of this, but
some of it we feel is outside of our control. So how
can you hold us accountable for everything?''
That being said, real results have been delivered by
hospital after hospital. So my question is: How much do you
think this tough love approach caused this acceleration of
change in terms of practices, and then what does that tell us
for other areas in which we can dedicate that kind of approach
to payment reform?
It seems to me that if it has worked here, it could
certainly work in other areas, even with respect to hospital
systems where there are real outliers in terms of excessive
practice, to just say, ``Listen, we're going to pay up to this
line, and we're not going to pay after that.'' If it's worked
here--and you'll have to tell me if you think it's worked
here--why wouldn't it work for other areas as well?
Dr. Conway. Thank you, Senator, for the question. I think
you make excellent points, and to reflect back, essentially, we
have had success for healthcare-acquired infections and
healthcare-acquired conditions. There's more work to do, but
there's been a significant improvement.
I think there's two major factors. There's an array of
minor factors, but I think the two major factors are payment
incentives that align with better care, and directly we're
targeted with specific measures and goals to decreasing
healthcare-acquired infections.
I think we've also made significant investments in
improvement in the field. So through our quality improvement
organizations, through CDC and public health departments,
through research, through our research agencies, through
Partnership for Patients--really helping hospitals and
clinicians with the hard work of improvement. And I think you
do need that technical assistance to drive that system
improvement to be successful.
I think we're starting to see success in other areas.
Hospital Value-Based Purchasing--we put this on our Web site
not so long ago. Over 80 percent of the measures have improved
significantly, so much so we're having to remove process
measures that are topped out and add in more outcome measures.
End-stage Renal Disease--there's a bundle and a quality
incentive program--costs controlled with the bundle and the
quality measures for dialysis care going up substantially in
this country. So I think the key is to align payment incentives
with better care and lower costs for populations of patients
and then invest in the technical assistance infrastructure and
technology to allow health systems to achieve those results.
Senator Murphy. Well, I would just encourage you to be bold
about this tough love approach with respect to reimbursement.
We are wasting billions of dollars on a small handful of
hospitals and healthcare systems around the country that have
just tremendous outlier rates in terms of utilization. And at
some point, we just have to decide to not pay for that.
Here's my question on bundles. Most of the payment reforms
have been directed toward how you pay hospitals. But, of
course, a lot of physicians that interact with those hospitals
are not necessarily part of that payment reform, because
they're getting paid separately.
What's our experience in terms of the cooperative
relationship between hospitals and physicians who may be
outside of those hospitals from an organizational standpoint?
And won't more bundled payments further encourage hospitals and
outside physicians who are using the hospital for procedures to
collaborate on a lot of the best practices that we've seen lead
to a dramatic decrease in infections?
I'd love to move faster when it comes to bundles payments.
I'd love for CMS to be looking more aggressively at new
bundles, whether it be in pilot programs or blowing them out
systemwide. And it seems to me that we would move faster on
controlling hospital-based infections if we had more bundled
payments, especially for surgical events in the hospitals.
Dr. Conway. I'll be brief, given the time. Your comments
are well taken. I think there are three points, briefly. On
accountable care organizations, a number of those are
physician-led, and we did advance payment models, and many of
those ACOs are collaborations which are successful.
On bundles, we also believe there is potential for
physicians to collaborate with hospitals and control cost and
improve quality substantially. And in our core payment
programs, where we have statutory authority to do bundling and
other innovative payment mechanisms, we are looking to do that,
and we look forward to working with you on these issues.
The Chairman. Thank you very much.
Thank you, Senator Murphy.
Senator Burr.
Statement of Senator Burr
Senator Burr. Thank you, Mr. Chairman.
Dr. Conway, I've heard you use payment incentives, quality
incentives, and I'm curious--and I'm not up to snuff enough on
how bundled payments work today or how these different
incentives work that you've mentioned. Is this really a
financial benefit to people who adopt it, or is it foregoing a
penalty that was in place?
Dr. Conway. In terms of the payment programs, let me
briefly go through them, because they vary in their setup.
Senator Burr. Well, without getting into the specifics, is
this actually more money through the reimbursement, or is it
less of a cut?
Dr. Conway. The majority of the programs--the Healthcare-
Acquired Conditions Program from 2008 was no additional funding
if these events occurred. The Healthcare-Acquired Conditions
Program that we just finalized was a set of measures, including
HAIs and HACs, that if you're in the bottom quartile of
performance, you get a negative payment adjustment.
The Hospital Value-Based Purchasing Program is budget
neutral. So about half of hospitals get more money because they
perform well, and half get less.
Senator Burr. Incentives always--when you use the word, one
expects that there's a financial benefit to individuals. So the
reason that there's not overall buy-in may be the fact that
there's not real incentives there. It's just the lack of maybe
what they feared.
Dr. Bell, what's the rate of HAIs from hospitals versus
HAIs from ambulatory outpatient surgery centers? Is there a
significant difference?
Dr. Bell. Our estimate of 1 in 20 infections is from
hospitals. We don't have very good estimates about ambulatory
surgery centers. It's one area, as I was mentioning to Senator
Isakson, where we really feel like we need better information.
Senator Burr. But isn't that a crucial comparison that we
need to make? I mean, as a layman, I would think that hospitals
were more susceptible because of the intervention needs of that
patient, where outpatient surgery centers--is it part of the
actual surgery where the infection is incurred, or is it in the
days after as they're in the facility?
Dr. Bell. These days, there are a lot more complicated
surgeries that are taking place in ambulatory surgery centers.
So this sort of clean break between the hospital and the
ambulatory surgery center is perhaps not as clean as it once
was.
Also, we've had many years now of work in hospitals to
reduce healthcare-associated infections, and we've shown
progress, for example, in reducing surgical site infections in
hospitals. We don't have the same history in ambulatory surgery
centers. And some of the principles that we've applied about
communication, about measurement, about team work, and about
infection control are really principles that we think need to
be strengthened in ambulatory surgery centers.
Senator Burr. Is there any dispute that the VA within their
hospital system decreased their infection rate with a simple
mandate that every person who enters a room uses a hand
sanitizer when they enter and uses a hand sanitizer when they
leave?
Dr. Bell. I'm not familiar with that specific instance with
the VA, Senator. But I can certainly agree that hand washing is
probably the single most important thing that anyone can do to
prevent transmission of infections.
Senator Burr. Has every hospital in the country adopted a
philosophy similar to that, where you sanitize before you go in
and you sanitize when you leave?
Dr. Bell. Yes, sir. I think that's probably fair to say.
Senator Burr. You think every hospital has adopted that?
Dr. Bell. I think every hospital certainly has a policy
about hand washing.
Senator Burr. Dr. Conway, I want to reiterate something
that I think Senator Isakson hit on, and I'm going to state it
in a slightly different way. If the reimbursement system that
we have in place suggests that you may or you may not be
reimbursed for innovation, let me suggest to you that
innovation will get to a point and not exceed that.
Now, if from a standpoint the studies that CDC is going
through, which I think have been supported, that in part it's
the changes in practices, in part it's fueling innovation for
new treatments so that we can cure the infection as quickly and
as cost effectively as we can, we can get to a point that we
can't get past if, in fact, there's not confidence that CMS
will properly reward the innovation from the bench. So we've
got legislation in place that promotes it.
I would say to my colleagues that's not necessarily going
to solve this problem if, in fact, people who venture down this
road aren't convinced that the reimbursement of their
intellectual property, their cost of development, in some
cases, half a billion dollars--and I think Dr. Bell was
correct--we're finding out the development of the next class of
antibiotics is going to be a very long time coming. If the
certainty is not there, this innovation won't happen.
I thank the Chair.
The Chairman. Thank you very much, Senator Burr.
Senator Casey.
Statement of Senator Casey
Senator Casey. Dr. Conway and Dr. Bell, thanks for your
testimony and for your good work. I wanted to focus on children
and, in particular, what a lot of the experts that we talk to--
and I know that you're both in that category--and, certainly,
child advocates always remind us that children aren't small
adults, so we always have to have treatment regimens and
approaches to them that might differ from how we deal with
adults.
Dr. Conway, I wanted to start with you. With regard to both
the question of hospital-acquired infections as well as the
efforts to reduce readmission rates, is there a particular
strategy or focus that you've brought to bear as it relates to
children? I notice in your testimony there's a section
entitled, Hospital Readmissions, but I didn't see anything in
there about children. Is there anything you can tell us about
how you approach children with regard to both those issues?
Dr. Conway. Senator Casey, thank you for the question.
Especially as a pediatrician, I always appreciate talking about
children. Two things--on the healthcare-acquired infections,
children are a focus. Actually, one of our hospital engagement
networks is a children's hospital association network led by
Steve Muething at Cincinnati Children's involving CHOP and many
leading children's institutions. They've generated dramatic
results in decreasing healthcare-acquired infections for
children--so I'd want you to hear that--really powerful, good
results.
On the readmissions, this is an area where I think it is
important to note that children have some differences from
adults, and there's some research in this area. So you have
more of your healthy children, who have one set of issues, on
sort of care coordination services--back to the community.
One of the major issues in pediatric healthcare for
readmission--and this is the population I mainly take care of
in the hospital--is children with multiple chronic conditions.
I think there, we really need to think about a medical home
that serves that family, from a social service as well as a
direct healthcare delivery standpoint.
A number of children's hospitals are doing very innovative
work on medical homes in neighborhoods and accountable care
organizations for children with complex healthcare needs. And
we'd love to help share some of that work and think through how
we could accelerate that work with you.
Senator Casey. With regard to the Affordable Care Act, both
as it relates to children and readmissions, but also more
broadly for the entire population, can you speak to the impact,
or can you measure the impact of the ACA to date on
readmissions?
Dr. Conway. On readmissions, when we started the
readmission program and our investment in QIOs and Partnership
for Patients--I have a run chart on my wall--a quality
improvement tool--that shows rock solid readmissions 19 percent
to 20 percent for decades in the Medicare population. And we
can come back to children.
One of my colleagues said it has dropped like a rock. It
has significantly declined in the last 18 months, and people
did not know if that was possible. And I think it's a combo of
negative payment adjustments for poor performance and investing
in quality improvement.
I was with colleagues, chief medical officers--and you'll
hear from one in a little bit--who said,
``You know, we used to have these care coordination
programs for people with congestive heart failure. We
stopped them because our hospital was losing money. Now
we've realigned those incentives.''
That same person told me just recently, ``We've reinvested
in these clinics that help coordinate care for people with
multiple chronic conditions.''
That's what we want out of our health system. We want a
coordinated health system where people are investing in better
health. In readmissions, we've made dramatic progress in
improvement across the Nation.
Senator Casey. In about a minute that I have left, Dr.
Bell, I wanted to ask you about--and you certainly spoke to
this in your testimony and by way of questions. But could you
just itemize for me the way that CDC is working with hospitals
on both--well, let me just limit it to hospital-acquired
infections. What's kind of the list of things that you engage
with them on?
Dr. Bell. Very quickly, first of all, we help hospitals
collect data about healthcare-associated infections and use
that data to benchmark and track progress and find problems.
That's the National Healthcare Safety Network. And this is an
infrastructure that's provided to hospitals and that they use
in real time.
Second, we provide them with tools to help them figure out
how to solve problems when they get them. These come out of our
guidelines and out of a lot of the sort of applied research
that we do to figure out what is the right thing to do.
And the third thing that we do with hospitals is oftentimes
connect them with other resources in the community, health
departments, CMS, QIOs, so that they can take advantage of all
the expertise that's available to them.
And, of course, fourth, we hate to see outbreaks, but at
the same time, we want people to be looking at what's going on
in their hospitals, and we support them and help in outbreak
investigations, in laboratory testing when things get very
complicated, and, generally speaking, in providing any other
kind of technical assistance of that sort.
Senator Casey. Thank you.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Casey.
Senator Baldwin.
Statement of Senator Baldwin
Senator Baldwin. Thank you, Mr. Chairman and Ranking
Member. I'm pleased that you've held this hearing today. It's
one of the key issues that we need to grapple with if we are
going to transform to a high-quality and lower-cost healthcare
system. I want to associate myself also with Senator
Whitehouse's remarks about urging the Administration to set a
numerical goal, a dollar goal, as opposed to the terminology
we've become so familiar with of bending the healthcare cost
curve, which is too nebulous, I have to say.
I wanted to make a couple of points and recognize, Mr.
Chairman, that you'd like to hear from our second panel, as
would I, before our votes are called on the floor at 11:45--but
just a couple of points and observations and maybe some comment
back. I'm very proud of the figures emerging out of Wisconsin.
It was almost a decade ago that a voluntary quality reporting
data base was created through a partnership, with very
promising reports. I think Wisconsin hospitals have a 56
percent lower level of healthcare-
acquired infections than the national average.
So we're proud of that, but obviously want to do better and
understand what public policy drives us in that direction as
well as what sort of private-public partnerships can advance
those goals. Over the August recess, I had a marvelous
opportunity to visit and have discussions on this very topic
with a couple of different folks.
I had a chance to visit a neonatal ICU. Senator Casey was
talking about children and adults. But especially with neonatal
centers, you have a patient who can't talk about their
symptoms, can't explain, and so we're relying on exceptional
diagnostics.
In that respect, I also want to share observations from a
visit I had with a small business called Isomark, a spin-off
from research at the University of Wisconsin, where they've
developed a patented technology that can be used to monitor the
breath and detect hospital-acquired infections perhaps as early
as a couple of hours after onset, serving to make treatment
more effective if the need for it can be identified early.
With those two themes in mind, I would ask what you are
seeing as the most effective private-public partnerships
driving down HAIs, and also the importance you see in early
detection of the onset of these infections in patients of all
ages.
Dr. Conway. I guess I'll start. Dr. Bell can continue. The
Wisconsin Quality Collaborative--I've been to Wisconsin and
seen that work and talked to Chris Queram, who leads a lot of
that work with just tremendous results. That actually will lead
to what I think is one of the most effective public-private
partnerships.
We are with quality collaboratives in States and regions
across this country, partnering with them, thinking about how
we can work together, how to drive quality improvement. Even in
our recent proposed rule, we put out a proposal where we could
potentially essentially deem some of these local measures of
quality as meeting Federal programs' needs if they met certain
requirements. We've gotten very positive feedback on that.
I applaud Wisconsin and really think those public-private
partnerships with collaboratives in the field working with
providers is one of our most effective public-private
partnerships. And we're doing that a lot through QIOs and
Partnership for Patients. Sorry. I'll try to talk faster.
On early diagnostics and innovation, I actually came from a
private sector background. We should reward and pay for
innovation. I think it's critical to do so. I don't know the
details of that diagnostic, but I'll say early detection--with
the residents and medical students I teach in the hospital, I
always tell them sepsis is a clinical diagnosis with your
clinical acumen and the diagnostic tools we have at our
disposal. You'll hear more about that in the next panel, but I
think it's critically important.
Dr. Bell. Thank you. Just to add a little bit, one of the
things that we at CDC have been doing is funding a prevention
collaborative--State health departments to set up prevention
collaboratives, including, I think, the State of Wisconsin. The
point there is for the State health department to be able to
look across the continuum of care in all the different groups
in a particular community that are working in this area and
bring them all together to take advantage of each of their
areas of expertise and identify problems and move forward.
I think that sort of underlying everything about
healthcare-associated infections is a public-private
partnership. And it's one of the roles that we'd like to see
State health departments play as they put together these
prevention collaboratives in States.
I think your point about early detection--CDC is all about
early detection. And I can't emphasize too much how critical it
is that hospitals learn how to identify infections early. As I
mentioned, it's just very unfortunate the number of outbreaks
that we end up investigating. And when we look back, we find
that there were any number of infections that had occurred, and
that somehow the dots were not connected, and there just wasn't
the kind of awareness that we'd better think about this, that
maybe something's going on.
That's something that we try to emphasize in every
situation. And, certainly, it's a message from many of our
outbreak investigations.
The Chairman. Thank you, Dr. Bell.
Thank you, Senator Baldwin.
Thank you both very much for your great testimony. Before
you leave, I'll just ask unanimous consent that the record stay
open for 10 days for additional statements and questions by
Senators. That would apply both to this panel and the next
panel.
Thank you both very much.
We'll call our second panel up and introduce them. Ciaran
Staunton is the co-founder of the Rory Staunton Foundation. Its
mission is to educate and conduct outreach efforts aimed at the
rapid diagnosis and treatment of sepsis, particularly in
children. I'll let Mr. Staunton tell his story, but it's a very
tragic story about his 12-year-old son, Rory.
We thank you for being here today, Mr. Staunton.
Dr. Jonathan Perlin is president of Clinical and Physician
Services and chief medical officer of HCA, the Hospital
Corporation of America. Dr. Perlin is responsible for leading
HCA's patient safety programs to eliminate preventable drug
resistant healthcare-associated infections.
Prior to that, Dr. Perlin served as Undersecretary for
Health in the U.S. Department of Veterans Affairs. As the
senior most physician in the Federal Government and Chief
Executive Officer of the Veterans Health Administration, Dr.
Perlin led the Nation's largest integrated health system.
And we thank you for joining us today.
Mr. Joe Kiani founded the Patient Safety Movement
Foundation, with a mission to reduce the 200,000 preventable
patient deaths that occur in U.S. hospitals every year. Under
Mr. Kiani's leadership, the Patient Safety Movement Foundation
held the first Patient Safety Science and Technology Summit in
January of this year with former President Clinton as the
keynote speaker.
Mr. Kiani is also the chairman of the board of the Masimo
Foundation for Ethics, Innovation, and Competition in
Healthcare to encourage and promote activities, programs, and
research opportunities that improve patient safety. He is also
the founder, chairman, and CEO of Masimo Corporation.
I'm sorry. I made an oversight. I want to yield to Senator
Alexander for purposes of an introduction.
Senator Alexander. I think you did a good job of
introducing Dr. Perlin.
The Chairman. I'm sorry. I didn't read my notes.
Senator Alexander. No, no. I join you in welcoming him. He
has appeared here before. He's the chief medical officer of the
Hospital Corporation of America, and he's been a leader in this
area. I look forward, especially, to his report about how HCA
has tackled this problem both in terms of prevention,
detection, and his comments about antibiotics and what we can
do there.
So thank you, Mr. Chairman, and thank you, Dr. Perlin, for
being here again.
The Chairman. Thank you, Senator Alexander.
Again, your statements will be made a part of the record in
their entirety. I'd ask that you sum up in 5 minutes.
Mr. Staunton, we'll start with you. Please proceed.
STATEMENT OF CIARAN STAUNTON, THE RORY STAUNTON FOUNDATION, NEW
YORK, NY
Mr. Staunton. Thank you, Mr. Chairman.
Thank you, Ranking Member Alexander, and members of the
Senate committee. And I thank your wonderful staff who have
organized us here today.
My name is Ciaran Staunton. I am Rory Staunton's dad. I'm
here today with my wife, Orlaith, and Rory's sister, Kathleen,
is also here with us today. Rory's Uncle Fergus is right behind
me. He is a Minister in the Irish government. They have
recently had some movement on sepsis themselves, some
initiatives.
Our son died from sepsis. However, before I give you our
personal testimony, I'd like to acknowledge all of the families
and the loved ones who are here today, including Carl Flatley
to my left, whose daughter, Erin, died from sepsis in 2002 at
the age of 23.
This is a long awaited day for many sepsis advocates, those
who have lost loved ones and sepsis survivors such as Renita
Kilby here, who came here in a wheelchair from Fredericksburg,
VA, and those in the medical profession globally who have
worked tirelessly to raise the awareness of sepsis. I thank you
all.
Mr. Chairman, I'm not going to go through a lot of
statistics, but I will give you a few facts that I hope
everyone watching and hearing remembers. Sepsis kills more
Americans than AIDS. Sepsis kills more American children than
pediatric cancer. Sepsis is the most expensive condition billed
to Medicare. Sepsis costs the American economy $17 billion a
year. It is the most expensive reason for hospitalization.
Our son, Rory, died tragically on April 1, 2012. Mr.
Chairman and Senator Casey, that was 2 weeks exactly after both
of you shook hands with our son in the White House on Saint
Patrick's Day. He was dead from sepsis. This was a day that no
parent ever wants to go through. It was the day a beautiful
young man died from sepsis, something we had never heard of
until our son was dead. It was the day our daughter, Kathleen,
lost her adoring big brother.
Following Rory's death, we read the statistics that 70
percent of Americans had never heard of sepsis. We also
discovered that it is one of the largest killers, not just in
the United States but in the world, yet sepsis has not received
the attention it deserves from governments throughout the world
or, indeed, our own government up until today. This is why the
Staunton family, through the Rory Staunton Foundation, is
determined to change this.
Our beloved son's tragic death from sepsis began on
Wednesday when he fell and scraped his elbow while playing in
his school gym. The gym teacher proceeded to cover the wound
without washing it and did not send him to the school nurse who
was in her office. This was the first of many institutional
failures.
When Rory came from school, he hung out, did his homework,
had some pizza, and went to bed. Later, my wife heard him in
the bathroom, and he was saying, ``It's my leg. It's my leg.''
The next morning, we called his pediatrician, Dr. Susan
Levitzky, immediately. Rory's temperature was 104. He never had
a temperature that high. We had tried some over-the-counter
medications. None of it was working.
She agreed to see him at 6 p.m. that evening. He was unable
to make it to the car, and his mom had to assist him. When we
got to the pediatrician's office, she noted that he was
shivering. He had 102 auxiliary. She noticed his pulse was 140,
his blood pressure was 100 over 60, and his respirations were
36 per minute. We pointed out his skin, which the pediatrician
noted as being mottled and blanched.
She noted that he had upper abdominal pain and had a cut on
his left elbow. We told her it was the pain in his leg that he
was screaming about. He vomited a large amount of yellowish
fluid, and Rory said, ``It's the pain in my leg that's
bothering me.'' The pediatrician said it was from the fall.
Nonetheless, she referred him to the emergency room for re-
hydration with a diagnosis of gastric flu. This represents the
second incidence of an institutional failure. At the emergency
room, they concurred with the diagnosis of gastric flu,
ignoring any other symptoms. They gave him IV fluids. We didn't
know then, but, in fact, blood tests were ordered stat. As far
as we know, they were never read.
What we do know is that he was discharged, and these blood
results, when returned to the ER, showed that among other
alarming signs, Rory's blood was producing white blood cells at
rates that were very abnormal and would suggest a serious
bacterial infection. Twelve minutes before Rory left NYU
Langone Hospital in New York, his vital signs were taken, and
his condition had deteriorated.
No one took the time to review all available information.
They discharged him, noting ``patient improved,'' despite the
fact that his vital signs were totally irregular and had
deteriorated since his arrival there. The hospital staff
concluded that he had a sick stomach and was suffering from
dehydration. This flu, they said, might take up to a week to
clear and that he would have diarrhea, but would feel better in
a few days. This was the third and final failure of an
institution, causing Rory's death.
On the following morning, Friday, Rory's temperature was
still very high. He was very tired. His leg hurt a lot, and he
was very dizzy. We were not convinced that this was a stomach
virus, and we began calling his pediatrician. She told us not
to worry about the temperature. She told us to focus on getting
food into him.
Despite our attempts to convince her that that was
impossible, we nonetheless tried to get Gatorade, Sprite,
ginger ale, Coke--anything we thought he would drink. We even
tried some chicken soup. He took one sip and returned to sleep.
He had diarrhea, and we were happy because we thought this was
what the pediatrician had told us was a sign of intestinal flu.
His mom stripped him down and checked to see if they had
missed a bug bite. She also checked him for signs of
meningitis. Finally, that evening, Mr. Chairman and members,
seeing our son's skin turn black and blue and his face begin to
turn yellow, we took him to the ER where all hell broke loose.
Despite the best efforts of the wonderful staff in the ICU,
our son, Rory, died at 6:29 p.m. on April the 1st. He was in
severe septic shock with multiple organ failure. Our beloved
son was the light of our lives. Some of you met him, as I said
earlier.
He was a child no one would ever forget. He was only 12
years old, and he was already five-foot-nine and over 160
pounds. He was very interested in life and had many questions
on international politics, science, technology, and the ways of
the world. And unlike many young children, CNN was his favorite
station.
He was captain of his school debate team, and he had won
many awards for speaking. He was on the Lego Robotics team. He
was elected by his peers to serve on the school's Student
Council.
An advocate for children with special needs and working in
conjunction with the Special Olympics, Rory had already set up
a campaign to curtail the use of the ``R'' word at his school.
The ``R'' word, meaning retard, is a word that is used as a
put-down term by some children. Rory was deeply upset by the
use of this word and had the children at his school sign a
pledge that they'd no longer use it.
He was a natural leader, eyeing a career in politics or
aviation. He dreamed of being the next Sully Sullenberger. He
read and reread Sully's memoir. Rory had already flown an
airplane for his 12th birthday. And although he was only six
when Rosa Parks died, he had already read everything about her.
Her bravery deeply affected him.
We believe, as those around him do, that the world has lost
an incredible human being who was also a fantastic big brother
to his sister Kathleen. After Rory died, we found a letter that
he had written to the Swedish Ambassador to North Korea asking
how a country like North Korea could afford such an enormous
army and have such a famine at the same time.
Mr. Chairman, we have most of the others in the records.
But let me just say that we, as a family, are compelled that no
other family should go through what we are going through. No
parent should have to buy a coffin for their child. No little
girl should have to say goodbye to her brother.
We see the statistics that are still going on, and we know
for a fact since we actually started our campaign, we have
received emails from people saying, ``Because of your campaign,
you have saved our child.'' And that is why we got New York
State to pass the Rory Regulations. Those regulations will save
between 6,000 and 8,000 New Yorkers every year.
What happened to Rory, unfortunately, could happen to any
of your children. It still happens, and we want to make sure
that everyone looking at this looks as a parent or a
grandparent. In Britain, they've already acknowledged they have
to re-look at us. It's our call to many.
And, finally, Mr. Chairman and members, sepsis is
treatable. Treatment reduces costs and saves lives. Our Rory
shouldn't have died. No one else's child should. And with the
help of these hearings today, many American lives will be
saved.
Thank you very much.
[The prepared statement of Mr. Staunton follows:]
Prepared Statement of Ciaran Staunton
Chairman Harkin, Ranking Member Alexander and members of the Senate
Health, Education, Labor, and Pensions Committee, and your wonderful
staff--thank you for inviting me here to testify at this important
hearing, ``U.S. Efforts to Reduce Healthcare-Associated Infections.''
My name is Ciaran Staunton. I am Rory's Staunton's dad. I am here today
with my wife, Orlaith and Rory's sister, Kathleen.
My son Rory died from sepsis. However, before I give you our
personal testimony, I would like to acknowledge all of the families and
loved ones who are here today including Carl Flatley, Erin Flatley's
dad. Erin died from sepsis at age 23 in 2002. This is a long awaited
day for sepsis advocates, those who have lost loved ones, sepsis
survivors, and for those in the medical profession globally, who have
worked tirelessly to raise awareness of sepsis. I thank you.
Sepsis kills more Americans than AIDS.
Sepsis kills more American children than pediatric cancer.
Sepsis is the most expensive condition billed to Medicare.
(Weir, HCUP Statistical Brief #107, 2011)
Sepsis costs the American economy over $17 billion a year.
It is the most expensive reason for hospitalization. (Hall, NCHS Data
Brief, No.62, 2011)
Our son Rory died tragically on April 1, 2012 and that was the day
our lives changed forever. It was the day that no parent ever wants to
go through. It was the day our beautiful young man died from sepsis,
something we had never heard of before. Following his death we read the
statistic that 70 percent of Americans had never heard of sepsis and we
also discovered that sepsis is one of the largest killers not only in
the United States but in the world. Yet, sepsis has not received the
attention it deserves from governments throughout the world or indeed
up until today in these United States. The Staunton family, through The
Rory Staunton Foundation, is determined to change this situation.
The story of our beloved Rory's tragic death from sepsis begins on
Wednesday when he fell and scraped his elbow playing in his school gym.
The gym teacher proceeded to cover the wound without washing it and did
not send him to the school nurse who was in her office. This was the
first of many institutional failures.
When Rory came from school he hung out, did his homework, ate some
pizza and went to bed. A little after midnight, in the early hours of
Thursday morning, we awoke to hear Rory throwing up in the bathroom,
not a lot of sickness but he was screaming ``my leg, my leg.'' My wife,
Orlaith brought him back to bed and he fell asleep as she rubbed his
leg. The following morning he had a fever and continued to complain of
the pain in his leg.
We began calling his pediatrician immediately as his temperature
was over 104 (he had never had a temperature that high) but more
worrying was that the over-the-counter medication commonly used, wasn't
bringing the temperature down. After many calls to the pediatrician's
office, she called us back and we insisted that she see him. She agreed
to see him at 6 p.m. that evening. On Thursday evening, supported by
his mom as he was unable to make the journey on his own, Rory made his
way to her office where she, the pediatrician noted that he was
shivering, had a fever of 102 auxiliary and had an extremely red
throat.
his pulse she noted as 140,
his blood pressure 100/60,
his respirations were 36 per minute.
We pointed out his skin, which the pediatrician noted as being
mottled and blanched.
She noted that he had upper abdominal pain and had a cut on his
left elbow.
We told her it was the pain in his leg that he was screaming about.
He vomited large amounts of yellowish fluid while in her office. Rory
said, ``It's the pain in my leg that's bothering me.'' The pediatrician
said it was from the fall, he said no.
Nonetheless she referred him to the Emergency Room for re-hydration
with a diagnosis of gastric flu. This represents the second incidence
of an institutional failure.
At the emergency room they concurred with the diagnosis of gastric
flu, ignoring any other symptoms present. They gave him IV fluids. We
didn't know then, but in fact blood tests were ordered stat., however
as far as we know they were never read.
What we do know is that he was discharged and these blood results,
when returned to the ER, showed among other alarming signs that his
blood was producing white blood cells at rates that were very abnormal
and would suggest a serious bacterial infection.
Twelve minutes before Rory left the hospital his vital signs were
taken, his condition had deteriorated. It appears that no one took the
time to review all available information. They discharged him noting
``patient improved,'' despite the fact that his vital signs were
totally irregular and had deteriorated since his arrival there. The
Hospital staff concluded he had a sick stomach was suffering from
dehydration.
This flu they said, might take up to a week to clear. They said he
will have diarrhea but will feel better in a few days. This was the
third and final failure of an institution causing Rory's death.
On the following morning, Friday, Rory's temperature continued to
be high, he was very tired, his leg hurt a lot and he had complained of
dizziness. We were not convinced of the stomach virus diagnosis, and we
began calling his pediatrician.
The pediatrician told us not to worry about the temperature. We
were told to focus on getting food into him. Despite our attempts to
convince her that that was impossible, we nonetheless bought him
Gatorade, sprite, ginger ale, coke--anything we thought he would drink.
Late that afternoon we made a trip to get chicken soup. He took one sip
and returned to sleep. He had diarrhea and we were elated as the
pediatrician told us to expect this--a common sign of intestinal flu.
We thought for sure this was definitely the stomach virus they told us
about.
His mom stripped him down and checked to see if they had missed a
bug bite. She also checked him for signs of meningitis.
Finally that evening, seeing his skin turn blue/black and his face
begin to turn yellow, we returned with him to the ER where all hell
broke loose. Despite the best efforts of the wonderful staff in the ICU
our son Rory died at 6:29 p.m. on that Sunday evening, April 1, 2012.
He was in severe septic shock with multiple organ failure.
Our beloved son Rory was the light of our lives. He should never
have died.
Rory was a child no one ever forgot. Although, only 12 years old,
he was already 59" tall and weighed over 160 pounds!
Rory was deeply interested in life and had many questions on
international politics, science, technology and the ways of the world.
In fact, CNN was his favorite station!
He was captain of his school debate team where he had won many
awards for speaking, he was on the Lego Robotics team, and he was
elected by his peers to serve on the school's Student Council.
An advocate for special needs children and working in conjunction
with the Special Olympics, Rory had already set up a campaign to
curtail the use of the ``R'' word at his school. The ``R'' word being
the word ``retard'', a put-down term used by some children. Rory was
deeply upset by the use of this word and had the children at his school
sign a pledge to stop using it.
He was a natural leader, eying a career in politics or aviation. He
dreamed of being the next Sully Sullenberger. He read and reread
Sully's memoir. He had already flown his first airplane, a 12th
birthday gift from us. Although he was only 6 when Rosa Parks died, he
had already read everything about her. Her bravery deeply affected him.
We believe, as those around him do, that the world has lost an
incredible human being who was also a fantastic big brother to his
sister Kathleen.
After Rory died we found a letter that he had written to the
Swedish Ambassador to North Korea asking how a country like North Korea
could afford such an enormous army and experience such famine at the
same time. Rory had such an incredible moral compass.
Rory was named President of ``Kidadelphia'', a country formed by
his neighborhood friends whose motto was, ``In God and Fun We Trust.''
Here is how others in the world saw Rory:
``He was the most profound 12-year-old I have met,'' Kevin
Burgoyne/Debate Coach and Sixth Grade Humanities teacher.
``It was possible to look at a child and, as an adult
said, I could be more like him,'' Roger Hitts, President Sunnyside
Gardens Park.
``Even after one meeting, I knew I would never forget him
and I would say the same about his sister Kathleen. Two powerful young
people,'' said, Pulitzer Prize winner and New York Times writer, Jim
Dwyer.
After he died, we discovered that Rory had died from sepsis. In our
deep state of despair we were shocked to find out that sepsis kills
more Americans than the combination of breast cancer, lung cancer and
stroke combined. It kills more Americans than AIDS. It is the largest
killer of children in the world--6 million.
We as a family felt compelled to ensure that no other child or
adult died because of this killer. We contacted our New York State
Governor Andrew Cuomo. He shared our anger and he immediately put us in
touch with the New York Health Commissioner Nirav Shah. Commissioner
Shah felt an urgent need to address sepsis and vowed to change New York
State policy.
Working with us, Commissioner Shah and Governor Cuomo announced the
introduction of ``Rory's Regulations.'' \1\ These regulations, named
for Rory now require all hospitals in New York State to adopt protocols
to identify and treat sepsis. The protocols will be evidence-based and
will in addition; deal with fluid resuscitation timeframes for infants
and children. It includes the demand for sepsis training of all staff
including laboratory and pharmacy. The sepsis regulations were adopted
on May 1, 2013 with the support of all New York hospitals. Rory's
Regulations will help New York set a ``gold-standard'' for patient
care. Governor Cuomo believes that 5,000 to 8,000 lives a year in the
State of New York will be saved as a result of Rory's Regulations.
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\1\ http://w3.health.state.ny.us/dbspace/propregs.nsf/
4ac9558781006774852569bd00512fda/4774b2c3cb19d1a385257b02005e2fdb.
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Sepsis is a medical emergency. It is the body's often deadly
response to infection. It requires early detection and treatment for
survival. Every minute counts. Administration of antibiotics and fluids
saves lives. For example, Intermountain Health Care in Utah reported
savings of $38 million per year as a result of a sepsis program. When
the Intermountain team launched a protocol-based approach to improving
sepsis care, the health system's 25 percent sepsis mortality rate was
already below the national average. Four years later Intermountain had
a 9 percent mortality rate; as a result, Intermountain saves 85 more
lives each year and saves $38 million in annual costs. (See Needles in
a Haystack: Seeking Knowledge with Clinical Informatics, PwC Health
Research Institute, 2012)
Experts agree that key to fighting sepsis is ensuring quick
diagnosis and treatment within the ``golden hour,'' when it can be most
effective.
The New England Journal of Medicine states,
`` . . . During septic shock, there is an absolute decrease
of 7.6 percentage points in the survival rate for each hour.''
((10.1056/NEJMe1203412) was published on May 22, 2012, at
NEJM.org) Global Sepsis Alliance concurs, that we must
`recognize sepsis as a medical emergency requiring
administration of fluids, antibiotics and other appropriate
treatments of infection within 1 hour of suspicion of sepsis.'
''
Pilot initiatives in some hospital systems have shown great strides
in decreasing sepsis mortality through effective implementation of what
is basically a ``check list''--a standardized protocol to facilitate
quick and accurate diagnosis and fast and effective treatment as soon
as any sign of sepsis arises. A recent multi-hospital report showed
that mortality rates dropped in half with these basic steps. (Miller,
Am J Resp Crit Care Med 2013).
If this strategy was applied to all Americans, it could save more
than 150,000 lives a year--more than 400 people a day,
But only one State has required these simple protocols be
implemented in all hospitals. New York State's adoption of Rory's
Regulations represents the first government in the United States
mandating evidence-based protocols for the early diagnosis and
treatment of sepsis.
Sepsis is a medical emergency. Sepsis needs to be suspected; once
it is suspected and treated we can save lives and save the U.S. economy
billions.
We are calling on Congress to institute a Federal nationwide
program of education on early detection of sepsis with similar
standards in all 50 States. We are also calling on Congress to create a
comprehensive educational resource so that doctors, nurses and, yes,
parents and patients can include sepsis as a possible diagnosis when a
patient shows up in an emergency room with similar symptoms to Rory.
Sepsis is not a deadly disease when caught in time. Antibiotics are
remarkably effective and many die from ignorance of how to recognize
the condition as Rory did.
Mr. Chairman we have heard from at least five sets of parents since
Rory died who are certain that Rory and the publicity surrounding his
case saved their children's lives when their kids began to suffer from
similar symptoms and they demanded that doctors test for it. We want to
ensure that it becomes common practice in every State in the union that
such tests and consideration of a sepsis diagnosis be the norm in
medical practice. There can be no more Rorys. Our hearts are broken and
we want to ensure that no other parent lives through this nightmare.
Know that the care that Rory received is not unusual for sepsis
patients in America, is this the care you would choose for your
children?
In Britain, the government there recently outlined a complete
overhaul of sepsis procedures after an examination that revealed 37,000
people had died, many of them needlessly.\2\ We in America can hardly
fail to match that.
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\2\ http://www.theguardian.com/society/2013/sep/12/nhs-patients-
dying-sepsis-care-failings.
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Rory's story of sepsis was a wakeup call to many. We believe that
knowledge is power. If we had known about sepsis, Rory would be alive
today. If Rory's doctors had suspected sepsis he would be alive today.
Unfortunately, there are many, many Rory's in the United States.
There is hope. Sepsis is treatable in a manner that reduces costs.
The Rory Staunton Foundation seeks to reduce the number of sepsis-
caused deaths through education and outreach. Our son Rory should not
have died. The Rory Staunton Foundation will work tirelessly to
advocate for changes and press ahead with awareness and education
regarding sepsis.
Thank you for your attention today.
The Chairman. Mr. Staunton, thank you very much, and I'm
sorry that in the interest of time we had to move on. But I
again want to thank you for turning your anguish not into a
withdrawal, but into a very positive movement--you and your
wife and your family--to use this terrible tragedy as something
to alert people and to, hopefully, engage people all around the
world to focus on this issue.
So my thanks to you and congratulations for having the
courage to do this in the face of this terrible tragedy in your
own family.
Mr. Staunton. Thank you for highlighting the case, sir, and
the whole issue, sir.
The Chairman. You bet.
Dr. Perlin.
STATEMENT OF JONATHAN B. PERLIN, M.D., Ph.D., MSHA, FACP,
FACMI, PRESIDENT, CLINICAL AND PHYSICIAN SERVICES AND CHIEF
MEDICAL OFFICER, HCA/HOSPITAL CORPORATION OF AMERICA,
NASHVILLE, TN
Dr. Perlin. Good morning, Chairman Harkin, Ranking Member
Alexander, and members of the committee. Thank you for the
opportunity to present this testimony. It is a privilege to be
here. I am Dr. Jonathan Perlin, president, Clinical and
Physician Services and chief medical officer of Hospital
Corporation of America.
First, I would like to take a moment to recognize the
family of Rory Staunton, to whom I offer my deepest sympathy
and whose commitment to elevating attention to sepsis and its
prevention inspires the work we do.
I would also like to take a moment to thank Senator Burr
and other members of the Senate Veterans Committee who are so
supportive in terms of improving health, infection prevention,
and outcomes for America's veterans in a way that could teach
all American healthcare.
Today, I would like to speak to how a learning health
system can help address some of our Nation's most pressing
challenges in infection prevention and patient safety, like
sepsis. Specifically, I would like to discuss how the REDUCE
MRSA study provides a model for rapidly and efficiently
accelerating the prevention of healthcare-associated infections
and could be applied to improving the early recognition and
treatment of sepsis.
Healthcare-associated infections, HAIs, or infections
acquired through medical care, afflict almost 2 million
patients annually. About 80,000 of those patients die. Most
HAIs are preventable. Beyond the catastrophic human toll,
avoidable infections also represent the unnecessary use of
healthcare resources.
A major concern with healthcare-associated infections is
antibiotic resistance. Used unnecessarily or inappropriately,
antibiotics kill the most susceptible organisms and, in their
void, create a favorable environment for the selection of more
resistant bacteria, resulting in a scary alphabet soup of
superbugs, including C. diff., MRSA, CRE, multidrug-resistant
TB, VRE, among others, that threaten even the healthiest
patients.
I'd like to talk about our work to combat one of these
superbugs, MRSA. HCA in partnership with CDC, AHRQ, Harvard
Pilgrim Health Care, UC Irvine, Rush Medical College, and
Washington University, recently concluded the REDUCE MRSA
study. MRSA, along with Staph aureus, generally, account for
approximately one-quarter of all deaths from hospital-acquired
infections. With the goal of preventing all potentially
avoidable harm, prevention of MRSA infections is a national
priority.
The REDUCE MRSA trial, conducted across 74 intensive care
units at 43 HCA-affiliated hospitals, involving 74,000
patients, answered the question of which of three alternative
approaches to prevent MRSA infection is truly best. The answer
sets a new standard for infection prevention.
This trial showed that universal decolonization, using
antimicrobial soap and nasal ointment at the time of admission
for all ICU patients, reduced all bloodstream infections,
including those caused by MRSA, by 44 percent. This study
demonstrates the power and efficiency of a learning health
system, defined by the Institute of Medicine as one committed
to both the generation and use of scientific evidence in
practice.
REDUCE MRSA is notable not only for its outcomes, but for
its methods. It didn't take a single hospital 43 years. It took
18 months. It didn't take a single-purpose research team, but
was implemented by healthcare professionals during the course
of routine patient care.
The study didn't occur in a laboratory, but within
community hospitals across the country. This type of pragmatic
research answers real-world questions in real-world
environments that generalize to real-world situations, and it
provides a powerful model for accelerating science.
The principles can be applied to accelerating the
understanding, prevention, and treatment of sepsis. Sepsis can
result from community and, as noted earlier, hospital-acquired
infections. Not everyone who has an infection develops sepsis,
yet everyone with sepsis has an infection.
The learning health system platform can help us discover
which clinical and biochemical indicators suggest risk for
sepsis, become sharper in recognizing sepsis and intervening
earlier, and build the evidence defining best treatment. The
current state-of-the-science provides insight into markers of
severe sepsis, and the state-of-the-art is to put the science
into use through a campaign to recognize severe sepsis as early
as possible.
But turning the clock back further is required.
Metaphorically, we can identify the building that's on fire. We
need to be able to recognize risk for sepsis, and that means we
need to be able to see the earliest signs of smoke, and even
prevent fires. Methods used in the REDUCE MRSA study can help
us identify early signals, test competing care strategies, and
determine the best practices in fighting sepsis and reducing
its catastrophic toll.
In closing, I would like to commend CDC and this committee,
Senator Harkin, Senator Alexander, and members, for your
support of a learning health system. HCA joins in your support
of CDC through its participation in the CDC Corporate
Roundtable. And REDUCE MRSA study was not only one of the
largest trials ever done. It was one of the most efficient. Its
results save lives, save resources, and suggest scientifically
informed policy.
Thus, I encourage your continuing support of the work of
CDC, AHRQ, NIH, CMS, and other Federal agencies in fostering
pragmatic research to combat the threat of antibiotic
resistance, healthcare-associated infections, and sepsis. I
would like to acknowledge our collaborators, in particular,
Richard Platt, Susan Huang, and John Jernigan, the CDC
Prevention Epicenters Program, and AHRQ.
On World Sepsis Day, and in the presence of the family of
Rory Staunton, it seems a fitting time to commit to a learning
health system.
Thank you, Chairman Harkin, Senator Alexander, and members
of the committee, for your leadership.
[The prepared statement of Dr. Perlin follows:]
Prepared Statement of Jonathan B. Perlin, M.D., Ph.D., MSHA, FACP,
FACMI
Good morning Chairman Harkin, Ranking Member Alexander, and members
of the committee. Thank you for the opportunity to present this
testimony--it is a privilege to be here. I am Dr. Jonathan Perlin,
president, Clinical and Physician Services and Chief Medical Officer of
Hospital Corporation of America (HCA).
First, I would like to take a moment to recognize the family of
Rory Staunton, to whom I offer my deepest sympathy and whose commitment
to elevating attention to sepsis and its prevention inspires the work
we do.
Today, I will speak to how a learning health system can help
address some of our Nation's most pressing challenges in infection
prevention and patient safety. Specifically, I would like to discuss
how lessons from the REDUCE MRSA study provide a model for rapidly and
efficiently accelerating the prevention of healthcare-associated
infections and could be applied to improving the early recognition and
treatment of sepsis.
background
Healthcare-associated infections (HAIs), or infections acquired
through medical care, afflict almost 2 million patients annually. About
80,000 of those patients die. Most HAIs are preventable. Beyond the
catastrophic human toll, avoidable infections also represent the
unnecessary use of healthcare resources.
A major concern with HAIs is antibiotic resistance. Used
unnecessarily or inappropriately, antibiotics kill the most susceptible
organisms and, in their void, create a favorable environment for the
selection of more resistant bacteria. This has resulted in a scary
alphabet soup of superbugs, including Clostridium difficile (C. diff),
Carbapenem-resistant Enterobactriaceae (CRE), Methicillin-resistant
Staphylococcus aureus (MRSA), multidrug-resistant tuberculosis (MDR
TB), and Vancomycin-resistant Enterococcus (VRE) that is threatening
even the healthiest patients.
In a recent report Antibiotic Resistance Threats in the United
States, 2013, The Centers for Disease Control and Prevention recommends
a four-pronged strategy to address resistance:
(1) prevention of infections;
(2) tracking resistant bacteria;
(3) improved use of antibiotics; and
(4) development of new antibiotics and diagnostic tests for
resistant bacteria.
This is complemented by increased attention to reducing the overuse
of antibiotics, selecting the most appropriate and organism-specific
antibiotic for each clinical situation, and prescribing and complying
with courses of therapy for the recommended duration of time. Good
stewardship, or the careful use of antibiotics in both humans and
animals, improves patient outcomes and enhances the prevention and
treatment of HAIs and sepsis.
reduce mrsa and the learning health system
I would like to talk about our work to combat one of these
superbugs, MRSA. HCA, in partnership with CDC, Harvard Pilgrim Health
Care, University of California Irvine School of Medicine, Rush Medical
College, and Washington University St Louis, recently concluded the
REDUCE MRSA trial.
Methicillin-resistant Staphylococcus aureus, more commonly known by
its abbreviation, MRSA, was identified in the recent CDC report as a
serious threat to human health. MRSA, along with Staphylococcus aureus
generally, account for approximately one-quarter of all deaths from
hospital-acquired infections. With the goal of preventing all
potentially avoidable harm, prevention of MRSA infections is a national
priority.
The REDUCE MRSA trial, conducted across 74 intensive care units
(ICUs) at 43 HCA-affiliated hospitals, involving 74,000 patients,
answered the question of which of three alternative approaches to
prevent MRSA infection in ICU patients is truly best. The answer sets a
new standard for infection prevention. This trial showed that universal
decolonization--using antimicrobial soap and nasal ointment at the time
of admission for all ICU patients--reduced all bloodstream infections,
including those caused by MRSA, by 44 percent.
This study demonstrates the power and efficiency of a learning
health system, defined by the Institute of Medicine (IOM) as one
committed to both the generation and use of scientific evidence. REDUCE
MRSA is notable not only for its outcomes, but for its methods. It
didn't take a single hospital 43 years to amass the power of this
study--it took 18 months. It didn't take a single-purpose research
team, but was implemented by nurses and infection prevention
professionals during the course of their routine patient care. The
study also didn't occur in a laboratory, but within community hospitals
across the country. This type of pragmatic research answers real-world
questions in real-world environments that generalize to real-world
situations, and it provides a powerful model for accelerating science.
For more detail of this trial, please refer to the article published in
the June 2013 edition of the New England Journal of Medicine, Targeted
versus Universal Decolonization to Prevent ICU Infection. Additional
information about the learning health system may be accessed through
the commentary published by the IOM, A win for the learning health
system. Both full-text articles are included as attachments.
sepsis and an opportunity to apply the learning health system
The learning health system, as employed in the REDUCE MRSA trial,
is critical to accelerating our understanding, prevention, and
treatment of sepsis. Sepsis is a final common pathway for a number of
diseases, including community and hospital-acquired infections. Not
everyone who has an infection will develop sepsis, yet everyone with
sepsis has an infection. The learning health system platform can help
us discover which clinical and biochemical indicators suggest risk for
sepsis, become sharper in recognizing sepsis and intervening earlier,
and build the evidence defining best treatment.
The current state-of-science provides insight into markers of
severe sepsis, and the state-of-the-art is to put this science into use
through a campaign to recognize sepsis as early as possible. But
turning the clock back further is required. Metaphorically, we can
identify the building that's on fire. We need to be able to recognize
risk for sepsis, and that means we need to see the earliest signs of
smoke, and even prevent fires. Methods used in the REDUCE MRSA study
can help us identify early signals, test competing care strategies, and
determine the best practices in fighting sepsis and reducing its
catastrophic toll.
conclusion
In closing, I would like to commend CDC, and this committee, for
support of a learning health system. The REDUCE MRSA study was not only
one of the largest trials ever done; it was one of the most efficient.
Its results save lives, save resources, and suggest scientifically
informed policy. Thus, I encourage your continuing support of the work
CDC, AHRQ, NIH and other Federal agencies do to foster pragmatic
research to combat the threat of antibiotic resistance, HAIs, and
sepsis. I would like to acknowledge all of our collaborators, in
particular Richard Platt, Susan Huang, and John Jernigan, the CDC
Prevention Epicenters Program, Harvard Pilgrim Health Care Institute,
and the Agency for Healthcare Research & Quality.
On World Sepsis Day, and in the presence of the family of Rory
Staunton, it seems a fitting time to commit to a learning health
system. Thank you, Chairman Harkin, Senator Alexander, and members of
the committee for your leadership.
References
1. Platt R, Huang SS, Perlin JB. A win for the learning health
system. Commentary. 2013. Institute of Medicine, Washington, DC. http:/
/www.iom.edu/WinforLHS.
2. Huang SS, Septimus E, Kleinman K, et al.; CDC Prevention
Epicenters Program and AHRQ DECIDE Network and Healthcare-Associated
Infections Program. Targeted versus universal decolonization to prevent
ICU infection. N Engl J Med. 2013; 368:2255-65. http://www.nejm.org/
doi/full/10.1056/NEJMoa1207290.
3. Platt R, Takvorian SU, Septimus E, et al. Cluster randomized
trials in comparative effectiveness research: randomizing hospitals to
test methods for prevention of healthcare-associated infections. Med
Care. 2010;48:Suppl: S52-S57. http://journals.lww.com/lww-medicalcare/
Pages/articleviewer.aspx?year=2010&Issue=060
01&article=00010&type=Fulltext.
The Chairman. Thank you very much, Dr. Perlin.
Mr. Kiani, please proceed.
STATEMENT OF JOE KIANI, FOUNDER, THE PATIENT SAFETY MOVEMENT,
IRVINE, CA
Mr. Kiani. Good morning, Chairman Harkin, Ranking Member
Alexander, and members of the committee. Thank you for holding
this very important and timely hearing, and thank you for the
opportunity to speak about the vital efforts underway to reduce
the number of healthcare-associated infections and preventable
hospital deaths each year.
First, I want to offer my condolences to Mr. and Mrs.
Staunton and the families of others who lost loved ones to
preventable hospital deaths, both those with us here today as
well as the millions of families who are not here.
I am here today because I decided that I can't wait for
another person to stop this tragedy. The number of preventable
deaths, at 200,000, has doubled since the original IOM report
of 100,000 in 1999. That's equivalent to two jumbo jets
crashing and killing everyone on board every day. I believe
that with your help, we can drop the number of preventable
deaths, if not to zero, then very close to that within the next
decade.
What I have discovered is that most, if not all, of the
causes of preventable hospital deaths have solutions that don't
require new research and development or FDA approval. I've also
discovered that no one knows the total number of preventable
deaths, let alone the number of deaths in each different
category of challenges. These facts, while shocking, spell huge
opportunity for dramatic improvement in patient safety.
Please allow me to tell you what we have done. We created
the Patient Safety Movement Foundation to aggressively address
this problem with a mission of zero preventable deaths by 2020.
We believe we can accomplish this by working together and
doing the following: unite the healthcare ecosystem, identify
the challenges that are killing patients to create actionable
solutions for them--we call these patient safety solutions--ask
hospitals to implement the patient safety solutions, promote
transparency, ask medical technology companies to commit to
share their data so that we can create the Patient Data Super
Highway and one day use it to help identify patients at risk,
correct misaligned incentives, and last but not least, promote
love and patient dignity.
I'm happy to report that many hospitals and medical
technology companies have already made their commitments and
are taking action. We also have made great progress with CMS
under Dr. Conway's leadership to do more to ensure patient
safety.
At the inaugural Patient Safety, Science, and Technology
Summit this year, we developed six patient safety solutions to
address the most common causes of preventable patient deaths.
At our next summit in January 2014, with the help from the
Joint Commission, we will unveil three to four more patient
safety solutions and steps we plan to take to achieve our goal
of zero by 2020. We will do this one hospital and one med tech
company at a time if we have to.
But you can move mountains. We want to thank you, Chairman
Harkin and Ranking Member Alexander, for holding this hearing
today to highlight this issue. Simply holding this hearing is a
great step forward. But you can do much more. We are looking to
you to lead and spur changes in government policies to achieve
our shared goal of zero preventable deaths by 2020.
We have humbly listed our recommendations in my written
testimony. But there are some highlights of things you can do
to move us much more quickly to zero preventable deaths that
I'd like to share with you here now.
No. 1, create transparency. Improve our understanding and
improve consumer choice and knowledge by creating a
standardized language and process to define, measure, and
report preventable hospital patient deaths, much like SEC does
for finance.
No. 2, provide hospitals with incentives and disincentives
to reduce preventable deaths. We believe if you suspend payment
for even the primary condition until it is determined whether
the cause of death was preventable, and when hospitals have not
implemented strategies to prevent these deaths, not pay it,
they will. Also, if hospitals implement strategies to prevent
patient death, not only should they be paid, but they should
also be shielded from malpractice lawsuits to the fullest
extent possible.
No. 3, create the Patient Data Super Highway. Grant ONC the
authority to investigate and decertify products that pursue
information blocking practices.
No. 4, promote patient dignity. Mandate that each hospital
identify a patient advocate so that their families can get help
in real time if they experience lack of empathy or problems
with their care.
And last but not least, in every healthcare-related bill
that you consider, be sure that innovation in healthcare is not
only not impeded, but it is promoted.
In conclusion, the good news is that preventing avoidable
patient deaths can largely be accomplished with solutions that
are available today. But we all need to act now. Every week, we
are losing 4,000 of our family members, neighbors, and friends
to preventable healthcare-associated infections and other forms
of preventable deaths.
If Congress creates laws that align the incentives of the
healthcare industry properly, we can reduce, if not completely
eliminate, preventable deaths. We are excited to work with you
on this problem and together achieve zero preventable deaths by
2020.
I look forward to your questions. Thank you.
[The prepared statement of Mr. Kiani follows:]
Prepared Statement of Joe Kiani
Good morning, Chairman Harkin, Ranking Member Alexander, and
members of the Senate Health, Education, Labor, and Pensions Committee.
Thank you for holding this very important and timely hearing and thank
you for the opportunity to speak about the issues related to patient
safety and the vital effort under way to reduce the number of
healthcare-associated infections and preventable hospital deaths each
year.
This is a major problem that is imminently addressable. Despite
this fact, healthcare-associated infections and other patient safety
hazards persist in causing needless deaths and suffering while
increasing healthcare costs. Healthcare-associated infections are a
subset of avoidable harms and the larger problem of preventable
institutional deaths.
Patient Safety is an issue that has been close to my heart and my
area of focus for more than 25 years. As a son of a dedicated nurse,
who taught me at a very young age how important it was to help others
in need, I grew up with a strong sense of commitment to use my
abilities to increase patient safety. As an engineer out of college, I
focused on innovation in healthcare and sought to create the best
medical technologies possible to deliver hope to families and to our
smallest patients--premature babies struggling for their lives. With
the assistance of many dedicated people, I have been able to help
improve patient care and reduce cost through development of
breakthrough technologies.
I fundamentally believe technology and innovation play an important
and critical role in the evolution of medicine and patient safety. We
know so much less than we could about the human body and disease. When
we actually understand the amazing human body and the root causes of
the diseases that plague it, I project our ability to treat, if not
prevent or cure, those diseases and the costs associated with this,
will be much improved. While we now understand this concept, we are
nowhere close to reaching this goal. Therefore, to slow down our
commitment to health care innovation would be as shortsighted as
failing to invest in the personal computer revolution 35 years ago. One
wonders where we would be had we followed the opinion of the Digital
Equipment Corp. co-founder, who infamously said in 1977: ``There is no
reason for any individual to have a computer in his home.'' That narrow
vision did not work for DEC and it would not have worked for the rest
of us, had we embraced it.
We are better off today than we were 100 years ago when the average
life expectancy in the United States was 48 years. Today, it is 78, but
we still can't prevent or cure many cancers, nor stop and reverse heart
disease. Yet, we can stop most, if not all of the 200,000-plus
preventable deaths that occur each year in our hospitals.
This will require an ``all-in'' commitment, and is the reason I
helped found the Patient Safety Movement, a ``Network of Creative
Cooperation,'' as President Clinton put it; a collection of caring
clinicians, patient advocates, hospitals, innovators and medical
technology companies, who came together to eliminate preventable deaths
by 2020. We believe there are seven major areas of work ahead of us:
Break down the silos and unify the healthcare ecosystem.
Promote transparency.
Create Safety Solutions to the challenges that are causing
preventable deaths.
Use incentives and disincentives to reduce preventable
deaths.
Eliminate misaligned incentives.
Create the ``Patient Data Super Highway.''
Promote Love and Patient Dignity.
At the Patient Safety Movement, we believe addressing the
challenges and capitalizing on the opportunities will require all
members of the health care ecosystem to actively engage in order to
eliminate preventable deaths. Congress has a big role to play in this
as you consider public policy options to improve patient safety.
Whether you are young or old, Republican or Democrat, black, or
white, religious or not, this is an issue that we all can and must
gather around to fix, and fix it now. I believe it is our moral
imperative to do all that we can now, because the solutions to many, if
not all, of the problems that lead to preventable deaths are available
today and do not require new science or FDA approval. They just require
us to act--individually and collectively. They require us to make a
stand so that mediocrity, disconnections, lack of conviction, apathy,
and an ``us and them'' mentality does not get in the way of what is
best for patients.
You have many tools at your disposal, from public health programs
that measure and track infections and deaths, to reimbursement systems
that create incentives to do the right thing. We stand ready and
willing to assist you if you step up and accept the safety challenge.
the patient safety challenges
Challenges that are causing the preventable deaths, such as
hospital-acquired infections, failure to rescue, and medication errors,
already have solutions that we just need to implement. But,
disconnected information and understanding of the patient care pathway
and the inability to share information among providers is another
problem that is costing us lives and dollars, and it's currently
without a solution. The case of 12-year-old Rory Staunton, who died of
sepsis at a New York hospital in July 2012, is a sad reminder of how
the lack of communication between providers, combined with the lack of
interoperability among multiple machines in the hospital can contribute
to tragedy.
Only a few days after suffering what appeared to be a minor cut
from a fall in his school gym, Rory passed away from a septic
infection. The data to save him was there--it just wasn't following him
as he visited his providers and wasn't being communicated properly, and
so no one connected the dots.
We need patient data in real time so that caregivers can be alerted
by predictive algorithms on the status of their patients in real time,
not after a preventable death has already occurred.
If we can bring the machines and IT all together with intelligent
predictive algorithms, physicians, along with patients and their
families can be informed of dangerous trends; lives can be saved; and
process of care can be improved substantially, further reducing cost.
Currently such algorithms can't be realized however, because there is
no easy means to integrate the data streams of the numerous medical
devices. The ``Patient Data Super Highway'' that is required for this
goal doesn't exist. This is because many companies do not allow other
companies to have access to the patient data their products produce or
capture.
While technology and processes may be arguably half of the
solution, empathy and love for the vulnerable is the other necessary
half. The dehumanization of people as soon as they become patients in
hospitals contributes to preventable deaths. We walk into hospitals as
the brave and free and turn into voiceless hostages of an unsympathetic
system. I don't buy the argument that if clinicians became involved
emotionally with their patients they may not do as good a job. Empathy
has a place in health care--it offers patients and their families'
dignity and can go a long way toward reducing stress and getting
patients and their families to become participants in the care and
safety of themselves or their loved ones. An unsympathetic system
contributes to suboptimal care, and it is one of the reasons patients
and their families often are eager to sue their caregivers if something
goes wrong.
patient safety: a challenge that we can, and must meet
Currently we are losing more than 200,000 of our loved ones each
year to preventable hospital deaths. Amanda Abbiehl, Lewis Blackman,
Leah Coufal, Emily Jerry, and Rory Staunton, are just 5 of the 200,000
precious lives we lose each year in our hospitals.
Each year in the United States, about 2.5 million people die.\1\ Of
those 2.5 million, 700,000 die in hospitals.\2\ Of the 700,000, experts
believe the number of preventable U.S. hospital deaths totaled more
than 200,000 last year. That is 3,800 deaths per week or more than 500
every single day. It is like 2 full jumbo jets crashing every day with
all aboard dying. These deaths far exceed motor vehicle accidents
(43,000), breast cancer (42,000), and AIDS (17,000)-related deaths,
combined.\3\
---------------------------------------------------------------------------
\1\ Murphy SL, et al. National vital statistics reports; vol 60 no
4. Hyattsville, MD: National Center for Health Statistics. 2012.
\2\ Trends in Inpatient Hospital Deaths: National Hospital
Discharge Survey. 2000-10. National Hospital Discharge Survey (NHDS)
data from 2000 through 2010. 118: March 2013.
\3\ HealthGrades Quality Study: Patient Safety in American
Hospitals, HealthGrades, July 2004.
---------------------------------------------------------------------------
These statistics are even more startling when you consider the
Institute of Medicine's report To Err is Human, which came out nearly
15 years ago, pegged the number at approximately 100,000 preventable
hospital deaths annually, at a cost of $29 billion.\4\ Now it's
200,000.
---------------------------------------------------------------------------
\4\ Kohn LT, et al. To Err Is Human: Building a Safer Health
System. Washington, DC: Institute of Medicine; 1999.
---------------------------------------------------------------------------
If we continue at this rate, by 2020 it is conceivable we would
lose more than 2 million of our loved ones to preventable hospital
deaths. To me, this is unacceptable. When you meet a family that has
lost a loved one, you realize how even one preventable death is
unacceptable, let alone 2 million!
Importantly, the numbers of adverse events caused by infections and
other issues is much higher. In 2010, an estimated 1.6 million Medicare
patients experienced an adverse event. Medicare's own data showed that
44 percent of these incidents were considered preventable.\5\
---------------------------------------------------------------------------
\5\ Levinson DR, et al. Adverse Events in Hospitals: National
Incidence Among Medicare Beneficiaries, Department of Health and Human
Services Office of the Inspector General, November 2010.
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cost impact
I am sure everyone in this room shares our belief that there is no
dollar value that can be put on a life lost, but the costs are
enormous. Consider the following:
Some studies report the economic cost of preventable
errors at $17 to $50 billion annually.\6\ \7\ Many of these errors
result in death.
---------------------------------------------------------------------------
\6\ Shreve, J, et al., The Economic Measurement of Medical Errors,
sponsored by Society of Actuaries Health Section, prepared by Milliman
Inc., Schaumburg, IL (June 2010).
\7\ Brennan, TA, et al., ``Incidence of Adverse Events and
Negligence in Hospitalized Patients: Results from the Harvard Medical
Practice Study I,'' New England Journal of Medicine, 324:370-76 (1991).
---------------------------------------------------------------------------
The Centers for Disease Control and Prevention reports
hospital-acquired infections lead to nearly 100,000 deaths and cost $30
billion each year. CDC estimates about 1.7 million HAIs annually.\8\
---------------------------------------------------------------------------
\8\ Journal of Medicine, 324:370-76 (1991). Scott, Douglas R.,
``The Direct Medical Costs of Healthcare-Associated Infections in U.S.
Hospitals and the Benefits of Prevention,'' Centers for Disease Control
and Prevention, (March 2009) accessed at http://www.cdc.gov/hai/pdfs/
hai/scott_costpaper.pdf.
---------------------------------------------------------------------------
Pressure ulcers and postoperative infection are the two
highest volume preventable errors and cost more than $6.5 billion
annually, according to researchers.\9\
---------------------------------------------------------------------------
\9\ Van den Bos, Jill; Rustagi, Karan; Gray, Travis; et al., ``The
$17.1 Billion Problem: The Annual Cost Of Measurable Medical Errors,''
Health Affairs, Volume: 30, Issue: 4 APR 2011.
There are many more examples, where saving patients' lives will
also save taxpayers, consumers and premium payers money. Clearly, the
opportunity is large and Congress should take steps to save money and
lives wherever prevention strategies are available.
patient safety movement foundation
We created the Patient Safety Movement Foundation to aggressively
address this problem with a mission of ZERO preventable deaths by 2020.
We believe we can accomplish this by working together and doing the
following:
1. Unify the healthcare ecosystem and secure commitments to action
from health care providers and others in the healthcare ecosystem;
2. Identify the challenges that are killing patients to create
actionable solutions to the challenges; We call these Patient Safety
Solutions;
3. Ask hospitals to implement the Patient Safety Solutions;
4. Promote transparency;
5. Align misaligned incentives;
6. Create and use the Patient Data Super Highway; and
7. Promote love and patient dignity.
The Patient Safety Movement is taking on this challenge and is
galvanizing the entire healthcare ecosystem. Part of the reason, we
experience 200,000+ preventable deaths after all of the work that has
been done since the IOM report is that all parties that impact patient
safety have not been at the table. While clinicians are responsible for
care at hospitals managed by administrators and supported by payers,
including the government, they utilize devices and drugs invented by
clinicians and companies. All of these entities are committed to
patient safety, but rarely have they all worked together to
collectively create and implement solutions to reduce preventable
deaths. We need to bring everyone together from doctors, nurses,
hospital administrators, patients, patient advocates, engineers,
government agencies, accreditation agencies, elected officials and
medical technology innovators to find actionable solutions to commit
and achieve ZERO preventable deaths as soon as possible.
We have many institutions that have already made their commitment
and are taking action, including Intermountain Healthcare in Salt Lake
City, Sinai Health System in Chicago, Mercy Hospital of Buffalo, Hoag
Hospital of Orange County, Medstar in Columbia, MD as well as the
American College of Obstetricians and Gynecologists, the Newborn
Coalition, and LeahsLegacy. We also have many medical technology
companies, including Cercacor, Cerner, Drager, GE Healthcare, Masimo,
Sonosite Fuji Film, Smiths Medical, Surgicount and Zoll who have
committed to share their data to benefit patients worldwide. Numerous
doctors, nurses, executive leaders, and patient advocates have
partnered with the Movement and are committing to do everything they
can to push toward ZERO preventable deaths.
At the Patient Safety Movement's first Patient Safety,
Science and Technology Summit, this past January, we successfully
secured the commitment of nine medical technology companies to share
their data. We thank them for their commitment to patient safety. These
are the first bridges we have built to help connect and construct the
Patient Data Super Highway. Former President Clinton has been
instrumental and been very supportive of this effort. He not only
attended our Summit, but is highlighting our work at this year's
Clinton Global Initiative meeting in New York. We developed six Patient
Safety Solutions to address the pressing problems of failure to rescue,
medication errors, transfusion overuse, intravascular catheter-related
infections, sub-optimal neonatal oxygen targeting, and failure to
detect critical congenital heart disease. Each of these solutions
identifies the gap, and highlights the necessary leadership, clinical
and technology steps to eliminate these problems.
We are working with the Joint Commission and seeking their
help to encourage implementation of Patient Safety Solutions.
We are working with CMS to educate and incorporate the
Patient Safety Solutions into Federal policy. We are very encouraged by
the pace that CMS, under the leadership of Dr. Patrick Conway, is
working with us on ideas for how we can make our hospitals and surgery
centers much safer.
We are working with elected officials to increase
awareness on the magnitude of the preventable death problem in our
hospitals and to develop and implement solutions.
All these steps have been taken in just 1 year. At our next summit
in January 2014, we will unveil even more Patient Safety Solutions and
steps we plan to take to achieve our zero by 2020 goal. We know our
movement is nascent, but we believe it is potent and reflects the
readiness and underlying desire by the healthcare ecosystem to put an
end to preventable hospital deaths.
We want to thank you Chairman Harkin and Ranking Member Alexander
for holding this hearing today to highlight this issue. We ask that
this hearing be the start, not the end, of your efforts to address
preventable deaths. We are looking to you to lead and spur changes in
government policies to further incent best practices and to achieve our
shared goal of zero preventable deaths by 2020.
the necessary legislative response
We know Congress and the Administration have been actively focused
on this issue of reducing preventable deaths and increasing patient
safety with many programs, but we humbly suggest the following:
Create a System of Transparency. Transparency is a
critical component in measuring and understanding the total number of
preventable hospital deaths and the root cause of each death. This
information will allow clinicians, policymakers, and others to take
proactive steps to reduce and eliminate needless mortality, going
forward. The current reporting systems do not require consistent,
accurate, measurable and electronic reporting on the total number and
causes of deaths, especially related to whether the death was
preventable. We cannot improve what we do not measure. You may be
surprised as I am, that today no one knows the exact number of deaths
due to preventable causes. That has to change immediately.
Recommendation: Government should take the lead in this
effort. To create transparency, and improve consumer choice and
knowledge, we believe there should be standardized processes to define,
measure and report Hospital Acquired Infections and Conditions by
hospital and in total. Reporting should be electronically facilitated
through the Meaningful Use program and via claim submissions. Congress
should require HAI and HAC rates to be publicly reported to facilitate
quality comparisons, much like SEC does for finance.
Use incentives and disincentives to reduce preventable
deaths.
Recommendation: We believe Congress should expand the current HAC
Medicare policy to include a list of causes of preventable death. We
believe Congress should suspend payment for even the primary condition
until it is determined whether the cause of death was preventable. If
preventable, and the hospital has implemented evidence-based strategies
for prevention, such as those indicated by the Patient Safety
Solutions, the hospital would receive payment for the primary
condition. If the hospital had not implemented the strategy, then
payments for both the primary and secondary conditions would be denied.
Also, if hospitals implement evidence-based practices such as the
Patient Safety Solutions, they should be shielded from malpractice
lawsuits to the fullest extent possible, such as through an affirmative
defense and limits on damages.
We believe Congress should also expand the current HAC Medicare
policy by expanding the non-payment policy for secondary conditions
that develop after a patient is admitted to a hospital. The current
list of conditions has not been updated since 2012, partly due to
limits on what conditions can be added. Currently, only preventable,
high-cost, high-volume conditions for which there are evidence-based
precautions are eligible. Congress should eliminate the ``high-cost,
high-volume'' limitation so that any known preventable condition is
eligible for the list if there is a clinical intervention strategy to
prevent it.
Create the ``Patient Data Super Highway.'' For more than a
decade Congress and the Administration have devised and implemented
policies to spur the use of information technology in healthcare. The
reasoning behind this is clear: seamless information technology should
enable us to identify problems in real time and resolve them before
they become deadly. As a result, medical professionals have begun to
increasingly rely on medical technology and information systems to
treat their patients. Today, however, these technologies are not always
able to communicate or interoperate. But this isn't always an issue of
design or standards: some technology vendors--as well as some
providers--pursue business practices to create what are called ``walled
gardens,'' which are strategies that block information sharing between
different systems in order to capture market share and/or additional
revenues in the future. This is an issue that has been identified by
the Office of the National Coordinator as a barrier to progress in the
Meaningful Use program. This practice fundamentally diminishes the
value of health IT, undermines congressional intent in enacting
programs to incentivize the use of technology in healthcare. These
practices are harming our progress to protect patients and must be
stopped; technology solutions must be required to openly share
information particularly when their purchase is subsidized with
taxpayer dollars and patients' lives are dependent on it. Rory
Staunton's case is an example of the problem and opportunity that lies
ahead. In fact, according to an article in the Los Angeles Times, 80
percent of medical errors in hospitals involve communication problems
between healthcare professionals.
Recommendation: We believe Congress should grant the Office of the
National Coordinator for Health Information Technology (ONC) the
authority to investigate and decertify products that pursue information
blocking practices. We shouldn't provide incentives or reimbursement
for products that do not openly share data freely with not just the
hospitals, but under HIPPA, to the patient and all parties that can use
it to improve patient safety.
Provide the Same incentive to Medical Technology Companies
that is offered to Hospitals. Today, there are no incentives, only
penalties, for medical technology companies that are trying to do the
right thing and identify why a patient was harmed by their product to
do so publicly. Hospitals are afforded protections for reporting
adverse events through Patient Safety Organizations.
Recommendation: Congress should extend the legal safe harbors
afforded to providers through Patient Safety Organizations to
technology vendors to promote transparency that will benefit the system
overall.
Promote Patient Dignity. Too often a patient's or a
family's cry for help is ignored. Patients and their families must be
partners with healthcare providers through education and engagement
strategies that empower both providers and consumers.
Recommendation: We believe there should be a Patient Advocate at
every hospital that patients or their families can access in real time
if they experience lack of empathy or problems with communication
related to their care.
conclusion
The good news is that preventing avoidable patient deaths can
largely be accomplished with solutions that are available today. But we
all need to act now. Every week, we are losing nearly 4,000 of our
family members, neighbors and friends to healthcare-associated
infections and other forms of preventable deaths. If Congress creates
laws that align the incentives of the healthcare ecosystem to encourage
innovation, transparency, cooperation, implementation of evidence-based
best-practices such as Patient Safety Solutions, and the creation of a
Patient Data Super Highway, we can reduce, if not completely eliminate,
preventable deaths.
We are excited to welcome Congress to the Healthcare Ecosystem and
work with Congress on solutions to this problem and together achieve
ZERO Preventable Patient Deaths by 2020.
______
Following is a summary of Patient Safety Programs to Reduce
Hospital Acquired Infections and Conditions. These are extremely
helpful but are not replacement for what we have suggested above.
cms
CMS has created a number of programs to improve Patient Safety.
The Innovation Center is engaged in a number of innovative projects
and is working to develop new payment and service delivery models to
improve patient safety.
The Partnership for Patients and its over 3,700 participating
hospitals are focused on making hospital care safer, more reliable, and
less costly through the achievement of two goals:
1. Making Care Safer. By the end of 2013, preventable hospital-
acquired conditions would decrease by 40 percent compared to 2010.
2. Improving Care Transitions. By the end of 2013, preventable
complications during a transition from one care setting to another
would be decreased so that all hospital readmissions would be reduced
by 20 percent compared to 2010.
CMS partners with AHRQ and CDC to develop an algorithm to identify
claims-based markers of HAIs originating at surgical care settings.
Programs are generally focused on hospital reporting or consumer-facing
tools to make the hospital and provider quality more transparent to
patients.
Inpatient Prospective Payment System Incentives (IPPS)
Hospitals are encouraged to treat patients
efficiently and to avoid infections because they receive a MS-
DRG-based payment for an inpatient stay.
Hospital Pay-for-Reporting
Gives patients quality of care information to make
more informed decisions about their healthcare and encourages
hospitals and clinicians to improve the quality of inpatient
care.
Hospitals that don't report on 10 specific
conditions are penalized.
Hospital Value-Based Purchasing (VBP)
A portion of hospital-base operating DRG payment
amount will be contingent on actual performance, rather than
reporting of measurement data, and must include hospital-
associated infection rates.
Hospital Readmission Reduction Program
Seven conditions make up almost 30 percent of
Medicare spending on readmissions. CMS developed reporting
measures for four of the seven.
The ACA includes penalties for hospitals that have
excess readmissions based on the readmission measures developed
by NQF.
Physician Quality Reporting System (PQRS)
A set of 74 quality measures.
Four are related to hospital acquired infections.
Providers receive incentives for reporting and
(starting in 2015) penalties for not reporting.
Physician Feedback Program and Value-Based Payment
Modifier
A Physician Value-Based Purchasing Program to improve
Medicare beneficiary health outcomes and experience.
Uses payment incentives and transparency to
encourage higher quality, more efficiently provided healthcare
services.
Shared Savings/Accountable Care Organizations
A coordinated care model for Medicare beneficiaries
that is required to report on quality including HAI levels.
ACOs with better quality and lower cost of care receive a
percentage of the money saved by Medicare.
Hospital Compare
Hospital Compare (www.hospitalcompare.hhs.gov) is a
Web site for consumers that provides information on how well
hospitals provide care to their patients with certain medical
conditions, including care related to the prevention of certain
infections.
Uses at Hospital Pay-for-Reporting requirements.
Physician Compare
Consumer-facing Web site that compares physicians
using PQRS Data.
Quality Reporting for Long-Term Care Hospitals, Inpatient
Rehabilitation Facilities and Hospice Program
These facilities are required to report new and
worsening pressure ulcers and CAUTI events.
Value-Based Purchasing for Skilled Nursing Facilities and
Home Health
Quality reporting requirements for the prevalence of
pressure ulcers.
Medicare Advantage
Medicare Advantage Private Fee-for-Service and
Medicare Savings Account plan must have an ongoing quality
improvement program that meets the regulatory requirements.
ahrq
AHRQ funds research to identify and promote effective HAI
prevention approaches as well as to identify gaps in the HAI science
that can be filled with additional research.
Comprehensive Unit-based Safety Program (CUSP)
An Intensive Care Unit Safety Reporting System
developed by the Johns Hopkins Quality and Safety Research
Group.
Focused on Central line-associated bloodstream
infections (CLABSI) and Catheter-associated urinary tract
infections (CAUTIs).
Surgical Unit-based Safety Program
An adaptation of the CUSP program focused on surgical
site infections (SSI) and ventilator-associated pneumonia
(VAP).
Patient Safety Organizations
Encourages clinicians and health care organizations
to voluntarily report and share quality and patient safety
information without fear of legal discovery.
cdc
The CDC Prevention Epicenters Program is a network of academic
centers with which CDC performs collaborative research on the
epidemiology and prevention of HAI.
Safety and Healthcare Epidemiology Prevention Research
Development (SHEPheRD) program
Includes academic experts in the field, large
healthcare facility networks interested in participating in HAI
prevention research, and entities with healthcare information
on large patient populations that can be used to measure
outcomes and the impact of prevention efforts.
Over 2,500 hospitals and insurers covering more
than 200 million lives are represented in the SHEPheRD program.
National Healthcare Safety Network & Emerging Infections
Program
Epidemiologic research that informs prevention
efforts and provides estimates of national HAI burden and
trends.
medicare
Medicare's ``never events'' policy that refuses payment for
clinical mishaps that are so horrific they should never happen is
helpful in reducing preventable deaths. Likewise, the current Medicare
Hospital Acquired Conditions policy, which refuses payment for
conditions in certain limited categories that develop after a hospital
admission, is helpful in making hospital clinicians and administrations
more aware of the financial consequences of avoidable conditions and
errors. Beginning in fiscal year 2015, the ACA reduces payments to
hospitals that have risk-adjusted HAC rates in the top quartile of
hospitals, but more must be done. Evidence-based practices are
available to address more conditions than are currently on the HAC
list, however no new conditions have been added to the list in 2 years,
despite advances in clinical evidence and technology. The Deficit
Reduction Act of 2005 (DRA) requires a quality adjustment in Medicare
Severity Diagnosis Related Group (MS-DRG) payments for certain
hospital-acquired conditions. CMS has titled the provision ``Hospital-
Acquired Conditions and Present on Admission Indicator Reporting'' (HAC
& POA).
For discharges occurring on or after October 1, 2008, Inpatient
Prospective Payment System (IPPS) hospitals do not receive the higher
payment for cases when one of the selected conditions is acquired
during hospitalization (i.e., was not present on admission). The case
is paid as though the secondary diagnosis is not present. For instance,
if a patient falls out of bed while in a hospital, the consequent
broken hip was not present on admission, so the ``complication'' of
``broken hip'' would be demoted as a ``Falls and trauma'' HAC. The
hospital would not be compensated for treatment of the injury. The
intent of this sort of classification is to force hospitals to prevent
such problems in the first place.
Pursuant to the Health Reform Law, beginning in fiscal year 2015,
hospitals will face an additional 1 percent reduction in Medicare
inpatient payments if they fall into the top 25 percent of national
risk-adjusted HAC rates for all hospitals in the previous year. The CBO
estimates this will reduce Medicare spending by $1.4 billion over the
2015-19 period. (Established by PPACA 3008 and 10309.)
The Hospital-Acquired Conditions payment provision applies only to
IPPS hospitals. At this time, the following hospitals are exempt from
the HAC payment provision:
Critical Access Hospitals (CAHs),
Long-Term Care Hospitals (LTCHs),
Maryland Waiver Hospitals,
Cancer Hospitals, Children's Inpatient Facilities,
Rural Health Clinics,
Federally Qualified Health Centers (FQHCs),
Religious Non-Medical Health Care Institutions,
Inpatient Psychiatric Hospitals,
Inpatient Rehabilitation Facilities (IRFs), and
Veterans Administration/Department of Defense Hospitals.
The law requires that, by October 1, 2007, the Secretary was
required to select, in consultation with the Centers for Disease
Control and Prevention (CDC), at least two conditions that: (a) Are
high cost, high volume, or both; (b) are assigned to a higher paying
MS-DRG when present as a secondary diagnosis (that is, conditions under
the MS-DRG system that are CCs or MCCs); and (c) could reasonably have
been prevented through the application of evidence-based guidelines.
Section 1886(d)(4)(D) of the Act also specifies that the list of
conditions may be revised, again in consultation with CDC, from time to
time as long as the list contains at least two conditions.
The current list of HACs is:
1. Foreign object retained after surgery.
2. Air embolism.
3. Blood incompatibility.
4. Pressure ulcer stages III and IV.
5. Falls and trauma, including:
a. Fractures,
b. Dislocations,
c. Intracranial injuries,
d. Crushing injuries,
e. Burns, and
f. Other injuries.
6. Vascular catheter-associated infection.
7. Catheter-associated urinary tract infection.
8. Manifestations of poor glycemic control, including:
a. Diabetic ketoacidosis,
b. Nonketotic hyperosmolar coma,
c. Hypoglycemic coma,
d. Secondary diabetes with ketoacidosis, and
e. Secondary diabetes with hyperosmolarity.
As specified by statute, CMS may revise the list of conditions that
could include other causes of preventable deaths.
The Chairman. Thank you very much, Mr. Kiani.
And to all of you, thank you. We'll start a round of 5-
minute questions, as soon as the clock gets reset. I've just
got 1 minute--if you can reset that.
Mr. Kiani and all of you, I always spend the night before
reading through the testimonies, and I always learn things. Mr.
Kiani, I learned from your testimony a lot of things. But I
didn't know the following hospitals are exempt from the
hospital-acquired condition payment provision: critical access
hospitals, long-term care hospitals, cancer hospitals,
children's inpatient facilities, federally qualified health
centers, inpatient psychiatric hospitals--I'm not going to read
them all--inpatient rehabilitation facilities, Veterans
Administration, Department of Defense hospitals.
I guess it's because they're paid differently. But surely
there's some way that we can apply the HAC payment provision or
something like that to those hospitals. Do you have any idea--I
mean, they may not be paid the same, but we still have the same
problems there. So how are we going to pull them into this
whole umbrella system that we have?
Mr. Kiani. Well, I humbly suggest, despite, like I said, us
all not carrying all the knowledge, that we need to create an
incentive and disincentive program. If you take your car for
service, and, accidentally, it gets set on fire, they're not
going to charge you for the service you took it in for. They,
in fact, try to replace your car. But, unfortunately, if
someone goes into a hospital, especially those hospitals, and
they acquire some condition, including dying from it, not only
do they not get the child back or their loved one back, but
government and other assurers have to pay the bill still for
what they went in for.
So I believe we need something more dramatic and, this
time, to include all of these different groups that you
mentioned so that they all have the incentive to do the right
thing, and also shield them from malpractice litigation if they
are putting steps in place to do the right thing.
The Chairman. Dr. Perlin, all the veterans hospitals are
exempted from this, but what can we do with the veterans
hospitals to bring them under some kind of a system like this?
Dr. Perlin. Well, I'm no longer at VA, but I can share that
VA, as in my current organization, HCA, uses something called a
patient safety learning system to understand and to make
continuous improvement.
Senator Harkin, members of the committee, when caregivers
go to work, their goal, which is really what attracted them to
healthcare, is to do the best job possible. Obviously, our
shared goal is to prevent all avoidable harm. I think what we
lack--and why I think the studies such as REDUCE MRSA are so
powerful in the work with CDC--is insight into building a safer
system.
Imagine a different scenario where there were simple tests
or simple clinical markers that would identify sepsis more
reliably. Building these sorts of system supports allows good
but fallible individuals to come to the best understanding of
disease and achieve best and safest outcomes for patients.
The Chairman. Well, it just seems to me that we've got a--I
was kind of surprised that all of those entities were exempted
from that, and I think that's something that we really ought to
take a look at.
The other thing that you mentioned was all the silos that
we have. And I mentioned this in my opening statement, about
the lack of communication. People have different proprietary
interest in certain software programs and things like that.
So someone is in a nursing home. They fall, they break
their hip, they go to the hospital, and now the hospital does
some surgery. But then they get an infection, they get MRSA,
and things pile up. But no one seems to know how they talk to
one another on this. How do we break that down?
Mr. Kiani. It's very simple, Chairman Harkin. I'm also CEO
of Masimo Corporation, and I'll be first to say we've been
guilty of hoarding our data so that one day perhaps we can do
something more with it for our business. And I really have to
admit it was the story of Mr. Staunton's son that made me
realize that that can't go on anymore.
So I called up to all of my colleagues that we have to
begin sharing our data. Let's not hide behind standards. Let's
just agree to make a commitment to share our data.
Already, GE Healthcare, Cerner, Drager, and many companies
have signed this commitment. If we can get the entire med tech
space to sign this commitment, I am sure that one day, we'll
have a real-time Patient Data Super Highway, and some smart
person, either living today or coming to life soon, will create
an algorithm that can tell when Mr. Staunton's son has all
these issues and can warn, if not the caregiver, them about
what's happening.
So I think it's just incentivizing them. Right now, we're
providing incentives for meaningful use to technologies like
EMR. And, unfortunately, some of them are not sharing their
data. They share it with the hospital, but they will not share
it with other of their so-called competitors, and, therefore,
the hospital is not going to come up with an algorithm that can
be used at the nursing home or another hospital.
Usually, private industry--someone will come up with that
algorithm. But if that data can't be accessed, there's no need
to make the algorithm.
The Chairman. Thank you very much.
Mr. Staunton. If I may say, sir, just one point is that
there's insufficient evidence and awareness about sepsis.
Education and awareness can save lives. We know for a fact that
since we spoke publicly about our case that we have saved
families. Now, that hasn't cost us anything apart from emotion.
Can anyone here imagine if the U.S. Government and every
agency started an education campaign on sepsis awareness, if
every mom and dad and doctor were looking for sepsis the same
as parents look for meningitis, that doesn't cost a nickel, but
would save millions.
The Chairman. Thank you, Mr. Staunton.
Senator Alexander.
Senator Alexander. Mr. Staunton, I join Senator Harkin in
thanking you and your family for what you are doing, or as he
said, turning your anguish into such constructive work on
behalf of other people.
Dr. Perlin, Senator Burr asked a little while ago about
whether there was a difference in the rate of infections when
you go into a hospital and when you go into an ambulatory
surgery center. You're in charge of a lot of hospitals. You're
in charge of a lot of outpatient centers. Do you see a
difference between the hospitals and the outpatient centers
that you manage?
Dr. Perlin. Well, first, I'd be remiss, Senator Alexander,
if I didn't thank you for your terrific leadership in
Tennessee. With what this country has to experience, we get the
privilege of working with Senator Alexander across our great
State, and thank you for that.
The ambulatory surgical center environment and the hospital
environment are slightly different. Hospitals do concentrate
the risk of patients who might be carrying other infections,
but good infection control practices have to be used in both
environments.
The truth is that our national data need to improve to
determine what the rates are. But what we do know is that among
patients who have surgery in hospitals--admittedly, the data
are only good for there--that, sadly, between 1 in 10 and 1 in
3 acquire infections, and up to 5 percent of those are surgical
site infections.
Now, toward understanding and preventing those, we're
actually following up. The same study team that did REDUCE MRSA
are working with CDC and others to actually implement a variety
of strategies to try to make that rate of what we believe to be
largely avoidable infections zero.
So I would encourage, first, better national surveillance
of infection rates in those environments. There are likely
similar problems in terms of infection prevention between both.
Either way, the rates are too high, and the goal has to be
zero. And we have, I think, a national need to ask CDC to help
us get better data on that.
Senator Alexander. Mr. Kiani has said that the goal should
be by 2020 to prevent these infections. I have brought up in
hearings here the importance of accountability. We're going
through that with dealing with the tragedy with fungal
meningitis in compounding pharmacies, a big part of which I
think came about because of confusion about who's in charge,
who's on the flagpole, who's responsible for this pharmacy or
that pharmacy. We're about to work that out.
I use the example of Hyman Rickover, the admiral who told
his submarine captains in the 1950s, ``If you're in charge of
the ship and you're in charge of the reactor, and if there's a
problem with the reactor, your career is over.'' And we've
never had a death from a reactor on a Navy submarine.
Now, you've had a lot of experience, both in government
with the VA and with now privately managed hospitals. When
we're dealing with lots of different institutions, we're always
tempted here in Washington to say--for example, President Obama
did the other day--the University of Tennessee is doing a good
job of graduating its students in 4 years, and someone will
say, ``Well, if they did that, let's apply it to all 6,000
universities.'' The President didn't say that, but we're
tempted to do that.
But we know it doesn't work when we just take a good idea
and make everybody do it. Based on your experience, what can we
do to fit into the strategy to reach Mr. Kiani's goal by 2020
without making it more difficult for hospitals and managers to
reach that goal? And how can we put somebody on the flagpole?
How can we make it clear who's accountable for reaching that
goal by 2020 so that we don't have infections in hospitals when
we go to get well and instead get sick?
Dr. Perlin. First, let me start by saying that our
immediate goal has to be no infections now, no preventable harm
now. We've talked about a number of strategies that don't have
to wait. Hand hygiene, members of this committee have already
alluded to. The rates are really insufficient. There needs to
be high reliability. And we need to hold ourselves accountable
for dealing with high reliability type behaviors, which means
hand hygiene before and after each and every patient encounter.
We can accelerate through a learning health system the
ability to bring together not only large sets of data, as was
mentioned, but to compare interventions and find out what works
best. It gives us not only the ability to create new evidence,
but also to apply it.
That's why in HCA we've applied the REDUCE MRSA universal
decolonization across all of our intensive care units. That's
why the CDC and others are building that into the infection
management or infection control compendium right now.
This is really a remarkable change. That study was a 44
percent reduction on top of every other best practice found.
When we have good science, we need to make sure that we apply
the science consistently and rigorously. And performance
measures are actually a very forceful mechanism of creating
transparency and thus accountability. So we actually like the
ability not only to have that transparency, but to identify
where good performance is occurring.
The Chairman. Thank you, Dr. Perlin.
Thank you, Senator Alexander.
The vote has started. We have less than 15 minutes to go,
but I'll recognize Senator Whitehouse.
Senator Whitehouse. I want to thank you all for being here
and again thank the Chairman and the Ranking Member for this
really important and useful hearing.
There's been some suggestion that we need to get a lot of
data, and I think that is correct. But it strikes me that while
we're waiting for the data, there's a lot that we can get done
right now that can begin now. I mentioned in my first round of
questions the Rhode Island Quality Institute and its effort
with the intensive care units across Rhode Island, every single
one in.
That really didn't boil down to anything much more than the
Pronovost checklist being applied and the nurses in the
intensive care units being told and empowered and believing
that it was within their job description to stop a procedure if
the checklist wasn't being complied with. It broke up the
doctor to nurse power structure a little bit, but it also
created incredibly good morale among ICU nurses, virtually
ended turnover, and it had this very salutary effect.
So it strikes me that those things are possible. They've
been possible for a long time, and yet despite the proven
success of the Pronovost principles, they haven't propagated as
widely as possible. It strikes me that the incentives really
matter--to give a hospital administrator the incentive, the
push, to go into the intensive care unit and to say to the
doctors there,
``Guys, there's going to be a new rule here, and that
is that the nurses can call off anything that you're
doing if you're not following these guidelines that
we've established. You don't get to wing it. You don't
get to cut corners.''
That's a tough conversation to have if you don't have an
incentive behind it. If you could comment on that, I'd
appreciate it.
Dr. Perlin. First, let me applaud the work of the Rhode
Island QIO. I know Laura Adams well, and she speaks of your
support of that organization, and it really has done just
extremely stunning and positive work.
You've indicated quite correctly that healthcare is a team
sport. We need to have the tools of communication and the tools
of empowerment. It was really in large part because of the work
on what we call in HCA our MRSA ABCs that CDC came to us to do
this REDUCE MRSA study. In fact, in part of the MRSA ABCs--
which, by the way, included compulsive hand hygiene as a
piece--there was the ability for members of the team to really
stop the line. That meant that nurses were empowered.
We actually worked with the central line manufacturers, the
producers of the devices, to actually put a card inside of that
package that expressed the principles that Peter Pronovost and
others used in the CUSP program so that even if people ``knew
that,'' it was a reminder right in front of them. And someone
could say, ``Dr. Perlin, I know you always do this right, but
just remember these are the five steps,'' and that's incredibly
important.
That creates an environment of shared accountability.
You've alluded earlier to ways in which, sometimes
inadvertently, hospitals, doctors, and others are misaligned.
But alignment--the fact that this is a team-based sport, using
the evidence that we have now, being a learning health system
creating new evidence--is demonstrated by great examples like
Rhode Island and elsewhere.
Senator Whitehouse. Thank you, Chairman.
The Chairman. Thank you, Senator Whitehouse.
Senator Casey.
Senator Casey. Mr. Chairman, thank you.
Ciaran, thank you for being here today and for offering
your personal witness. I can't even imagine what you and your
family have been through. And when we talked many months ago,
you gave me an insight that I didn't have before, and I'm
grateful for that. I'm glad that you've been able to have the
strength to share your story with the country and also to
motivate all of us to focus on this problem.
I know Ciaran, and I know Joe Kiani, and, Doctor, I don't
know you. But I know how all three of you are committed to
this.
I know we're really short on time. I just have one question
for Ciaran and then Joe. We'll do some questions for the
record.
But, Ciaran, how about any kind of report you can give us
on kind of a state-by-state comparison or update? I know New
York State, as you mentioned, has moved forward. But what's
your best sense of that and what we can do to encourage States?
Mr. Staunton. Thank you, Senator Casey. We know, for
example, that New York's regulations, the Rory Regulations in
New York passed by Governor Cuomo, will save 7,000 to 8,000
lives a year. And that is one page, like that. That's what
saves us. If that was nationally, every State, perhaps we could
save a couple of hundred thousand people a year.
We also know that there is also in a number of hospitals
what's called a checklist, a standardized protocol to
facilitate quick and accurate diagnosis and fast and effective
treatment as soon as any sign of sepsis arises. This has been
used in a number of hospitals. Mortality rates have dropped by
50 percent.
If this was applied across the USA, it would save more than
150,000 lives a year. That's 400 people a day that could be
saved. So what we're saying is, first and foremost, there has
to be awareness. Sepsis is a medical emergency. If it's
suspected, it can be treated, and there you save a lot of
people.
Our son could have been treated. If my wife or I or anyone
had heard the word, sepsis, as every parent here knows--you go
through the list of what it might be, and that's where that
would have come in.
So what we are saying today, Senator Casey, is that if
Congress looks at this nationwide, what we did in New York,
what it has done, and here's how much you can save--a hospital
in Utah, for instance, brought their mortality rate down to 9
percent on sepsis and also saved $36 million that year. So it
saves them a lot of money.
What we would like to see Congress do is create a
comprehensive educational resource so doctors, nurses, parents,
patients, all of us can include sepsis as a possible diagnosis
so when a patient shows up in an emergency room, like our son,
Rory, that they suspect sepsis. And if you suspect sepsis, you
save a life. And that's it. That's it. That's 400,000 people.
Someone said earlier we need numbers, not curves. This
number is $17 billion a year that sepsis is costing in care
that can be saved. Awareness is what we are saying, and this is
the first one. And thank you very much, Senator Casey.
Senator Casey. Ciaran, thank you so much. And I would hope
that a lot of our hospitals wouldn't wait for a law to be
passed. But we'll continue to work with you on moving it
forward.
I know we're really out of time, but, Joe, maybe in 1
minute, I wanted to ask you about the patient advocates and the
role that they play. I know there's a lot more we could cover
with you and with Ciaran and Dr. Perlin, but we're down to
about 3 minutes to vote.
Mr. Kiani. Thank you. I'll be very brief. We talked about
the silos that, unfortunately, have been amongst us all. One of
the silos has been the patient advocates not being part of the
equation. When we hear a number like 200,000, it's easy to just
think of it as a statistic and not personalize it.
The patient advocate being in the room--I remind you of
that one patient, whether it's Rory or it's Lenore Alexander's
daughter back here--it reminds you not only of just how
critical one life is, but it reminds everybody in the room,
whether it's the med tech companies, hospitals, engineers, or
doctors, that we have to unite to solve even one death, let
alone over 200,000 a year.
Senator Casey. Thank you very much.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Casey.
Thank you all very much.
I'll just ask one question, Mr. Staunton, about those
Rory's Regulations in New York. Did they go to all hospitals,
even those I mentioned, that Mr. Kiani pointed out were exempt?
Mr. Staunton. Everything in New York is covered under the
Rory's Regulations in New York. There are no exemptions in New
York, sir. Everyone has to suspect sepsis.
The Chairman. I know we're very late. In fact, I'm going to
miss a vote. Go ahead. I'll be right with you.
Do you know if other States have picked up on this?
Mr. Staunton. Not yet, sir. There is hope that we may take
it--I know there's been some hearings in Connecticut, Rhode
Island, and Florida. But we would----
The Chairman. When did New York adopt these regulations?
Mr. Staunton. January the 1st of this year.
The Chairman. Interesting. I'm going to check on that.
Mr. Staunton. And we'll provide your staff with a copy of
it, sir. Your staff has been excellent. Thank you very much.
[The information referred to may be found in additional
material.]
The Chairman. I appreciate it very much.
Thank you all very much. I'll just close where I started.
These hospital-acquired conditions and infections is something
that we can win. We can win this. We've got to break down these
silos. We've got to have transparency. We've got to have
communication, software that talks to one another. We need the
kind of regulations in every State so that they recognize
sepsis.
MRSA can lead to sepsis. So we've got to take a look also
at MRSA, as Senator Isakson was talking about.
With this, I thank you all very much. I'm sorry we're going
to have to rush off from this hearing. But thank you for all
you're doing, and we look forward to continuing our dialogue
with you with written questions.
Thank you all very much. The committee will stand
adjourned.
[Additional material follows.]
ADDITIONAL MATERIAL
Proposed Regulations: New York State Department of Health
Proposed Rule Making: Amendment of Sections 405.2 and 405.4 of Title 10
NYCRR (Hospital Sepsis Protocols)
Publication Date: 02/13/2013
Comment Period Expiration: 04/01/2013
proposed text and statements
Pursuant to the authority vested in the Public Health and Health
Planning Council and the Commissioner of Health by Sections 2800 and
2803 of the Public Health Law, Sections 405.2 and 405.4 of Title 10
(Health) of the Official Compilation of Codes, Rules and Regulations of
the State of New York are hereby amended, to be effective upon
publication of a Notice of Adoption in the New York State Register, to
read as follows:
Paragraphs (6) and (7) of subdivision (f) of section 405.2 are
amended and a new paragraph (8) is added to read as follows:
(f) Care of patients. The governing body shall require that
the following patient care practices are implemented, shall
monitor the hospital's compliance with these patient care
practices, and shall take corrective action as necessary to
attain compliance:
* * *
(6) hospitals which conduct, or propose to conduct,
or otherwise authorize human research on patients or
other human subjects shall adopt and implement policies
and procedures pursuant to the provisions of Public
Health Law, article 24-A for the protection of human
subjects; [and]
(7) hospitals shall have available at all times
personnel sufficient to meet patient care needs[.]; and
(8) hospitals shall have in place evidence-based
protocols for the early recognition and treatment of
patients with severe sepsis/septic shock that are based
on generally accepted standards of care as required by
subdivision (a) of section 405.4 of this Part.
New paragraphs (4), (5), (6), (7) and (8) are added to subdivision
(a) of section 405.4 to read as follows:
405.4 Medical staff.
(a) Medical staff accountability. The medical staff shall be
organized and accountable to the governing body for the quality of
medical care provided to all patients.
* * *
(4) The medical staff shall adopt, implement,
periodically update and submit to the Department
evidence-based protocols for the early recognition and
treatment of patients with sepsis, severe sepsis and
septic shock (``sepsis protocols'') that are based on
generally accepted standards of care. Sepsis protocols
must include components specific to the identification,
care and treatment of adults and of children, and must
clearly identify where and when components will differ
for adults and for children. These protocols must
include the following components:
(i) a process for the screening and early
recognition of patients with sepsis, severe
sepsis and septic shock;
(ii) a process to identify and document
individuals appropriate for treatment through
severe sepsis protocols, including explicit
criteria defining those patients who should be
excluded from the protocols, such as patients
with certain clinical conditions or who have
elected palliative care;
(iii) guidelines for hemodynamic support with
explicit physiologic and biomarker treatment
goals, methodology for invasive or non-invasive
hemodynamic monitoring, and timeframe goals;
(iv) for infants and children, guidelines for
fluid resuscitation with explicit timeframes
for vascular access and fluid delivery
consistent with current, evidence-based
guidelines for severe sepsis and septic shock
with defined therapeutic goals for children;
(v) a procedure for identification of
infectious source and delivery of early
antibiotics with timeframe goals; and
(vi) criteria for use, where appropriate, of
an invasive protocol and for use of vasoactive
agents.
(5) The medical staff shall ensure that professional
staff with direct patient care responsibilities and, as
appropriate, staff with indirect patient care
responsibilities, including, but not limited to
laboratory and pharmacy staff, are periodically trained
to implement sepsis protocols required pursuant to
paragraph (4) of this subdivision. Medical staff shall
ensure updated training when the hospital initiates
substantive changes to the protocols.
(6) Hospitals shall submit sepsis protocols required
pursuant to paragraph (4) of this subdivision to the
Department for review on or before July 1, 2013.
Hospitals must implement these protocols no later than
45 days after receipt of a letter from the Department
indicating that the proposed protocols have been
reviewed and determined to be consistent with the
criteria established in this Part. Hospitals must
update protocols based on newly emerging evidence-based
standards. Protocols are to be resubmitted at the
request of the Department, not more frequently than
once every 2 years unless the Department identifies
hospital-specific performance concerns.
(7) Collection and reporting of sepsis measures.
(i) The medical staff shall be responsible
for the collection, use, and reporting of
quality measures related to the recognition and
treatment of severe sepsis for purposes of
internal quality improvement and hospital
reporting to the Department. Such measures
shall include, but not be limited to, data
sufficient to evaluate each hospital's
adherence rate to its own sepsis protocols,
including adherence to timeframes and
implementation of all protocol components for
adults and children.
(ii) Hospitals shall submit data specified by
the Department to permit the Department to
develop risk-adjusted sepsis mortality rates in
consultation with appropriate national,
hospital and expert stakeholders.
(iii) Such data shall be reported annually,
or more frequently at the request of the
Department, and shall be subject to audit at
the discretion of the Department.
(8) Definitions. For the purposes of this section,
the following terms shall have the following meanings:
(i) sepsis shall mean a proven or suspected
infection accompanied by a systemic
inflammatory response;
(ii) severe sepsis shall mean sepsis plus at
least one sign of hypoperfusion or organ
dysfunction; and
(iii) septic shock shall mean severe sepsis
with persistent hypotension or cardiovascular
organ dysfunction despite adequate IV fluid
resuscitation.
regulatory impact statement
Statutory Authority
Public Health Law (``PHL'') Section 2800 provides that ``[h]ospital
and related services including health-related service of the highest
quality, efficiently provided and properly utilized at a reasonable
cost, are of vital concern to the public health. In order to provide
for the protection and promotion of the health of the inhabitants of
the State . . . , the department of health shall have the central,
comprehensive responsibility for the development and administration of
the State's policy with respect to hospital related services . . .''
PHL Section 2803 authorizes the Public Health and Health Planning
Council (``PHHPC'') to adopt rules and regulations to implement the
purposes and provisions of PHL Article 28, and to establish minimum
standards governing the operation of health care facilities.
Legislative Objectives
The legislative objectives of PHL Article 28 include the protection
of the health of the residents of the State by promoting the efficient
provision and proper utilization of high quality health services at a
reasonable cost.
Needs and Benefits
Sepsis is a range of clinical conditions caused by the body's
systemic response to an infection and affects about 750,000 people in
the United States each year. The mortality rate is alarming--between 20
percent and 50 percent--and the rate largely depends on how quickly
patients are diagnosed and treated with powerful antibiotics to battle
the bacteria racing through their systems.
In New York State the number of severe sepsis cases increased from
26,001 in 2005 to 43,608 in 2011--an increase of 68%. Similarly, the
number of sepsis cases in New York State increased from 71,049 in 2005
to 100,073 in 2011, an increase of 41%. Sepsis mortality is significant
and ranges widely from one hospital to another. In New York, sepsis
mortality ranges between 15 percent and 37 percent. A patient may have
a greater chance of dying from sepsis if care is provided by an
institution ill-prepared to deal with this illness or from providers
not thoroughly trained in identifying and treating sepsis.
The likelihood of death following initial diagnosis of sepsis is
more than 20%, and the window for administering effective treatment is
short. Mortality rates from severe sepsis are on a similar scale to
lung, breast, and colon cancer, and it is one of the leading causes of
death in the intensive care unit. Sepsis kills more people than HIV/
AIDS, prostate cancer, and breast cancer combined.
The 28-day mortality rate in sepsis patients is comparable to the
1960s hospital mortality rate for patients of acute myocardial
infarction (``AMI''). Over recent years, there has been an improvement
in the awareness and management of AMI, resulting in a decline in
mortality, while sepsis remains an unacknowledged killer.
The number of severe sepsis cases is expected to grow at a rate of
1.5% annually, adding an additional one million cases per year in the
United States alone by 2020. This will increase total mortality and
increase the burden on health care resources. The increase is mainly
due to the growing use of invasive procedures, immune system modifying
therapies and increasing numbers of elderly and high-risk individuals,
such as those with diabetes, cancer and HIV. Older people are at an
increased risk of sepsis as they are more vulnerable to infections due
to aging, co-morbidities, use of invasive procedures, and problems
associated with institutionalization. Individuals with diabetes,
cancer, and HIV are at increased risk due to immune system and other
dysfunction caused by their disease or its treatment.
Sepsis places a significant burden on health care resources,
accounting for 40% of total ICU expenditures. Sepsis costs our health
care system an estimated $17 billion annually, and the average cost of
treating the condition is $50,000. (See http://www.nigms.nih.gov/
Education/factsheet_sepsis.htm.)
The rapid diagnosis and management of sepsis is critical to
successful treatment. The sepsis patient is usually already critically
ill and requires immediate attention to avoid rapid deterioration;
therefore, it is necessary to treat the patient at the same time as
confirming the diagnosis. Due to the challenges of diagnosing and
treating this complex condition, approximately 10% of sepsis patients
do not receive prompt appropriate antibiotic therapy, which increases
mortality by 10 to 15%.
In the absence of adoption of protocols as required by these
regulations, it is estimated that New York will see dramatic increases
in cases of sepsis and sepsis mortality as the numbers of persons who
are at risk continue to increase.
Hospitals can significantly impact sepsis morbidity and mortality
by adopting standard protocols. For example, since the implementation
of Kaiser Permanente's Northern California sepsis program mortality has
been reduced for patients admitted to hospitals with sepsis, by more
than 40 percent--and saved more than 1,400 lives. Similarly, Regions
Hospital in Minnesota reports that initiatives launched in 2005 led to
more than a 60 percent drop in sepsis mortality by 2011, and
Intermountain Health Care reports a reduction in its sepsis mortality
rate from 25% to 9%, saving 85 lives and $38 million annually. (See
Needles in a Haystack: Seeking Knowledge with Clinical Informatics, PwC
Health Research Institute, 2012.)
In particular, these regulations will promote the early
identification and treatment of sepsis at general hospitals by focusing
on the following areas:
Recognition of risk factors, signs and symptoms of sepsis;
Resuscitation with rapid intravenous fluids and
administration of antibiotics upon diagnosis of sepsis;
Referral to appropriate clinicians and teams as
appropriate;
Measurement and evaluation of current practices for
purposes of informing future policy; and
Quality Improvement measures that will permit development
and dissemination of best practices through clinical and administrative
information sharing.
The Department of Health (``the Department'') will publish guidance
to assist facilities in developing protocols that include an
appropriate process for screening all patients to ensure early
recognition of patients with possible sepsis and, once possible sepsis
has been documented, establishing clear timeframes for administration
of antibiotics and full protocol implementation. At a conference of
stakeholders, including hospital systems, convened by the Department in
2012, it emerged that the current best practice is to pursue
administration of antibiotics and fluid resuscitation within 1 hour of
a diagnosis of sepsis, with full implementation of sepsis protocols
within 3 hours for severe sepsis and 6 hours for septic shock. Given
continual advancements in medical research and practice, these
timeframes could change and accordingly will be set forth in guidance
which will be updated as appropriate.
These regulations, requiring hospitals to adopt protocols to
identify and treat sepsis, and another set of regulations requiring
hospitals to provide patients and their parents or other medical
decisionmakers with critical information about the patient's care and
to post a Parent's Bill of Rights, were inspired by the case of Rory
Staunton, a 12-year-old boy who died of sepsis in April 2012. Both sets
of regulations, together known as ``Rory's Regulations,'' will help New
York State set a ``gold standard'' for patient care.
costs
Costs for the Implementation of and Continuing Compliance with these
Regulations to the Regulated Entity
Costs to the regulated entities are expected to be minimal and to
be primarily associated with the following: (a) adoption of and
compliance with evidence-based protocols; (b) reporting information to
inform risk-adjusted sepsis mortality measures; and (c) training staff
to implement the sepsis protocols. It is likely that hospitals will
realize overall cost savings as a result of early identification and
treatment (see below).
In fact, many hospitals throughout the State are currently
implementing sepsis initiatives. The Greater New York Hospital
Association (``GNYHA'') and the United Hospital Fund (``UHF'') have
launched a joint program called the ``Strengthening Treatment and
Outcomes for Patients Sepsis Collaborative;'' the North Shore-LIJ
Health System recently launched an education program to train emergency
and critical care nurses on how to identify sepsis at its earliest
stages and provide treatment to improve patient outcomes; and the
Healthcare Association of New York State (``HANYS'') has organized a
collaborative to improve the identification and management of sepsis
and test the value of collaborative improvement projects versus
traditional medical and clinical staff education. This regulation will
build on and support these initiatives going forward.
Research conducted nationally suggests the possibility of a
significant return on investment. As noted, Intermountain Health Care
in Utah has reported savings of $38 million per year due to its sepsis
program, and reports more favorable reimbursement from insurers for
identifying potential septic patients faster and treating them in the
intensive care unit earlier. (See Needles in a Haystack: Seeking
Knowledge with Clinical Informatics, PwC Health Research Institute,
2012.)
In New York State, Stony Brook University Medical Center
(``SBUMC'') reports that a recent campaign to reduce sepsis mortality
was extremely successful, resulting in a 49 percent reduction in
mortality and a decrease in length of stay for patients with severe
sepsis. This resulted in a cost savings of more than $740,000 for the
153 severe sepsis patients at SBUMC in 2010. (See http://www.naph.org/
Homepage-Sections/Explore/Innovations/Preventing-Hospital-Acquired-
Conditions/Stony-Brook-Reduces-Sepsis-Mortality.aspx.) Similarly, a
recent sepsis initiative at South Nassau Communities Hospital resulted
in a 44% reduction in sepsis mortality (See HANYS Quality Institute,
Healthcare Association of New York State, Leading the Quest for Quality
2011 Profiles in Quality and Patient Safety.) Similar savings to those
reported by SBUMC are likely.
Costs to Local and State Government
There is no anticipated fiscal impact to State or local government
as a result of this regulation, except that hospitals operated by the
State or local governments will incur minimal costs, offset by savings,
as discussed above.
Costs to the Department of Health
There will be minimal additional costs to the Department of Health
associated with the following: review of protocols submitted by
hospitals to the Department; general programmatic oversight;
development of measures to evaluate the impact of these regulations as
they relate to the adoption of evidence-based sepsis protocols; and
creation of a data system for purposes of analysis and reporting.
Local Government Mandates
Hospitals operated by State or local government will be affected
and be subject to the same requirements as any other hospital licensed
under PHL Article 28.
Paperwork
Consistent with these regulations all hospitals will be required to
submit evidence of the following:
(a) adoption of an evidence-based sepsis protocol initially and
then once every 2 years after that.
(b) information sufficient to evaluate each hospital's adherence to
its own sepsis protocol, including adherence to timeframes and
implementation of all protocol components for adults and children;
(c) data, as specified by the Department, to permit the evaluation
of risk-adjusted severe sepsis mortality rates.
Duplication
These regulations do not conflict with any State or Federal rules.
Implementation of these regulations represents the first time New York
State has required that facilities submit indication of adherence to
evidence-based protocols for the early detection and treatment of
sepsis and to report outcomes (risk-adjusted mortality). Thus, there is
no duplication.
Alternative Approaches
There are no viable alternatives. Implementation of these
regulations is predicated on strong evidence indicating the
effectiveness of implementing evidence-based protocols. In addition to
requiring that all hospitals throughout the State develop and implement
evidence-based sepsis protocols, the regulations will require
submission of data to the Department. This will allow the Department to
monitor adherence to protocols, measure the impact of the protocols
through risk-adjusted mortality statistics, and use the data and
information obtained to inform the development of quality improvement
initiatives.
Federal Requirements
Currently there are no federal requirements regarding the adoption
of sepsis protocols or for reporting adherence to protocols or risk-
adjusted mortality.
In December 2012, the National Quality Forum included a proposed
measure of adherence to treatment bundles for patients treated for
sepsis. This measure, which is currently under consideration, would
focus on patients 18 years of age and older who present symptoms of
severe sepsis or septic shock who are eligible for the 3-hour (severe
sepsis) and/or 6-hour (septic shock) early management bundle. The
regulations proposed by the Department to measure adherence with
established sepsis protocols will seek to be in alignment with the NQF
measure when adopted.
Compliance Schedule
These regulations will take effect upon publication of a Notice of
Adoption in the New York State Register.
Contact Person: Katherine Ceroalo, New York State Department of
Health, Bureau of House Counsel, Regulatory Affairs Unit, Corning Tower
Building, Room 2438, Empire State Plaza, Albany, NY 12237, 518-473-
7488, 518-473-2019-FAX, [email protected].
regulatory flexibility analysis for small business and local
governments
Effect of Rule
The provisions of these regulations will apply to the 228 general
hospitals in New York State, including 18 general hospitals operated by
local governments. Three general hospitals in the State are considered
small businesses. These hospitals will not be affected in any way
different from any other hospital.
Compliance Requirements
Compliance requirements are applicable to those three hospitals
considered small businesses as well as the 18 hospitals operated by
local governments. Compliance will require: (a) adoption of and
compliance with the required sepsis protocols; (b) training staff to
implement the sepsis protocols; and (c) reporting information to inform
risk-adjusted sepsis mortality measures.
Professional Services
Professional services are not anticipated to be impacted as a
result of the following: (a) reporting the adoption of and compliance
with the required sepsis protocols; (b) training staff to implement the
sepsis protocols; and (c) reporting information to inform risk-adjusted
sepsis mortality measure.
Compliance Costs
Compliance costs associated with these regulations will be minimal
and will arise as a result of: (a) adopting and complying with
evidence-based protocols; (b) reporting information to inform risk-
adjusted Sepsis mortality measures; and (c) training staff to implement
the sepsis protocols. This will apply to those hospitals (three)
defined as small businesses.
Economic and Technological Feasibility
It is economically and technologically feasible for small
businesses to comply with these regulations.
Minimizing Adverse Impact
Adverse impact will be minimized through the provision of time
sufficient to comply with the regulations. More specifically impacted
entities will have a minimum of 90 days following adoption of these
regulations to have sepsis protocols in place and at least 6 months
before information to inform risk adjusted mortality measures will have
to be reported to the Department.
Small Business and Local Government Participation
These regulations have been discussed with hospital associations
that represent hospitals throughout the State, including those that are
small businesses and operated by local governments, who are supportive
of this initiative.
Cure Period
Chapter 524 of the Laws of 2011 requires agencies to include a
``cure period'' or other opportunity for ameliorative action to prevent
the imposition of penalties on the party or parties subject to
enforcement when developing a regulation or explain in the Regulatory
Flexibility Analysis why one was not included. This regulation creates
no new penalty or sanction. Hence, a cure period is not required.
rural area flexibility analysis
Effect of Rule
The provisions of these regulations will apply to general hospitals
in New York State, including 47 general hospitals located in rural
areas of the State. These hospitals will not be affected in any way
different from any other hospital.
Compliance Requirements
Compliance requirements are applicable to those hospitals located
in rural areas. Compliance will require: (a) adoption of and compliance
with the required sepsis protocols; (b) training staff to implement the
sepsis protocols; and (c) reporting information to inform risk-adjusted
sepsis mortality measures.
Professional Services
Professional services will not be impacted as a result of these
regulations.
Compliance Costs
Compliance costs associated with these regulations will be minimal
and will arise as a result of: (a) adopting and complying with
evidence-based protocols; (b) reporting information to inform risk-
adjusted Sepsis mortality measures; and (c) training staff to implement
the sepsis protocols. This will apply to those hospitals located in
rural areas of New York State.
Minimizing Adverse Impact
Adverse impact will be minimized through the provision of time
sufficient to comply with the regulations. More specifically impacted
entities will have a minimum of 90 days following adoption of these
regulations to have sepsis protocols in place and at least 6 months
before information to inform risk-adjusted mortality measures will have
to be reported to the Department.
Rural Area Participation
These regulations have been discussed with hospital associations
that represent hospitals throughout the State, including those that are
located in rural areas, who are supportive of this initiative.
job impact statement
Pursuant to the State Administrative Procedure Act (SAPA) section
201-a(2)(a), a Job Impact Statement for this amendment is not required
because it is apparent from the nature and purposes of the proposed
rules that they will not have a substantial adverse impact on jobs and
employment opportunities.
Response by Patrick Conway, M.D., MSc to Questions of Senator Murphy
Question 1. Considering that hospitals are a prime arena for
priority attention in reducing Healthcare-associated infections (HAIs),
have you considered the role of antimicrobial copper surfaces in
reducing infections acquired in a hospital setting? The research
surrounding the use of copper on certain surfaces where pathogens can
live, such as bed rails and door knobs, is intriguing to me as we
examine ways that we can reduce Healthcare-associated infections (HAIs)
and unnecessary hospital readmissions. Are you familiar with the
research in this area? And do you consider this application of copper
surfaces to be a useful tool for reducing infections?
Answer 1. We are familiar with the research in this area, and we
are committed to the reduction of infections in hospitals and other
patient care settings. This research is still in its very earliest
stages, and more research is needed. You are correct in describing this
approach as ``intriguing.'' The approach is very innovative and holds
great promise. We will continue to interact with national and
international authorities on infection control to inform our policies
in supporting the work to reduce HAIs.
Question 2. You mentioned in your testimony the role that Quality
Improvement Organizations (QIOs) play in reducing healthcare associated
infections. How would this important work change if CMS were to move
from the current State-based model to a regional network?
Answer 2. The important role that QIOs play in working with
hospitals and other providers to reduce HAIs will not in any way be
reduced. Moreover, we believe that additional flexibility in defining
the geographic areas for the QIOs activities will enhance system
efficiencies, streamline the QIO work, and allow targeting of program
expertise in a way that will most effectively establish and spread best
practices. As the science of quality improvement continues to evolve
rapidly, we believe that the QIO program should evolve as well to more
effectively reduce and prevent HAIs and other events of harm, and
further enhance quality-improvement initiatives.
______
National Center for Emerging and Zoonotic
Infectious
Diseases, Centers for Disease Control and
Prevention,
U.S. Department of Health and Human Services,
Atlanta, GA, 30333,
September 24, 2013.
Dear Mr. Chairman: On September 24, 2013, the Centers for Disease
Control and Prevention (CDC) testified at a hearing before the
Committee on Health, Education, Labor, and Pensions entitled ``U.S.
Efforts to Reduce Healthcare-Associated Infections.'' This letter
provides responses for the record to questions posed by certain members
of the committee, which we received on November 7, 2013.
CDC works 24-7 to save lives and protect people from harm. CDC has
prioritized the prevention of healthcare-associated infections (HAIs)
as one of the agency's Winnable Battles--public health priorities with
large-scale impact on health and with known, effective strategies to
address them.
HAIs include a variety of infections ranging from those related to
specialized intensive care procedures like mechanical ventilation, to
infections caused by lapses in basic safe practices, like re-using
disposable syringes or inappropriate cleaning of equipment. HAIs are
associated with increased mortality and greater cost of care, and can
occur in any healthcare setting--hospitals, long-term acute care,
dialysis clinics, ambulatory surgical centers, nursing homes/skilled
nursing facilities, and even doctors' offices. In the worst cases, HAIs
can lead to sepsis, a dangerous body-wide inflammation that can result
in organ failure and death. Primary prevention of HAIs stops a root-
cause of sepsis.
CDC's portfolio of activities is critical to improving the capacity
of healthcare facilities and States to detect HAIs and protect patients
and communities.
If you have further questions, please contact Michael Craig at
[email protected].
Sincerely,
Beth P. Bell, M.D., M.P.H.,
Director.
Response by Beth Bell, M.D., M.P.H. to Questions of Senator Harkin,
Senator Casey, Senator Hagan, and Senator Murphy
senator harkin
Question. Has CDC/CMS reviewed the DOD-funded copper clinical trial
results? If so, what is their opinion? Do they believe the use of
copper furnishings in hospitals has significant potential for reducing
bacterial loadings or harmful healthcare infection rates?
Answer. CDC has reviewed the DOD-funded copper clinical trial
results by Salgado et al.\1\ This study demonstrated a significant
reduction in HAIs and/or colonization with healthcare pathogens.
Antimicrobial copper has been repeatedly shown to result in moderate
reductions in environmental surface contamination, although it is not
known what degree of bacteria reduction is necessary to affect HAI or
colonization outcomes.
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\1\ http://www.ncbi.nlm.nih.gov/pubmed/23571364.
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HAI elimination is a priority at CDC and we are always looking for
new and innovative ways to increase the safety of health care,
including surface treatments such as silver alloys and copper. CDC
recommendations for new practices or technologies are based on peer-
reviewed scientific evidence of both effectiveness and safety, as well
as an assessment of potential unintended consequences of such
innovations. Adjunct measures such as copper products would not replace
standard infection control practices, but they might play a useful role
in reducing infections in health care settings. However, additional
research will be needed before any recommendations can be made on the
appropriate role of using copper to reduce HAIs, and CDC is interested
in pursuing work in this area.
senator casey
Question 1. Is the CDC working with medical providers and the
public to raise awareness of sepsis?
Question 2. If so, what steps have been taken, or what programs
exist, to encourage timely diagnosis of sepsis?
Question 3. Is the United States learning from best practices that
have been adopted around the world--including in the EU--to diagnose
and monitor sepsis?
I understand that CDC has recommended reducing unnecessary
antibiotic usage as a means of addressing the rise of antibiotic
resistance bacteria.
Question 4. Do U.S. patients often receive preventive antibiotics
while they're awaiting diagnostic test results that may take hours or
days? And how can the United States ensure that at-risk patients are
monitored for the development of sepsis without being given unnecessary
antibiotics?
Answers 1-4. Primary prevention of HAIs stops a root-cause of
sepsis. Eliminating HAIs is a priority for the Department and its
Federal agencies, evidenced by the ``HHS Action Plan to Eliminate
Health Care-Associated Infections: Road Map to Elimination.'' \2\ CDC
data indicate that at any given time, approximately 1 in 20
hospitalized patients has an HAI and over 1 million infections occur
each year across healthcare settings. In the worst cases, some HAIs can
lead to sepsis, a dangerous body-wide inflammation that can result in
organ failure and death.
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\2\ http://www.hhs.gov/ash/initiatives/hai/actionplan/.
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Using multiple detect-and-protect strategies, CDC's world-class
experts target HAIs and the drug resistant pathogens that can cause
them, including:
monitoring HAIs and evaluating their risk factors,
establishing benchmarks and targets, and tracking prevention progress
toward those goals,
detecting and responding to emerging and urgent threats
through outbreak investigation and laboratory science,
developing guidelines for HAI prevention and filling gaps
in knowledge through applied research,
implementing prevention strategies with Federal and State
partners.
CDC promotes primary prevention of sepsis by preventing HAIs from
occurring in the first place. Some examples include the promotion of
vaccination and smoking cessation to prevent community-acquired
pneumonia or the careful insertion of central venous catheters in
hospitals to prevent bloodstream infections.
However, the reality is that infections do occur despite our best
prevention efforts. CDC is working to understand and ultimately prevent
mortality and morbidity from severe sepsis. Researchers in CDC's
Emerging Infections Program (EIP) are working to characterize which
patients develop severe sepsis, their underlying conditions, the
infectious causes, and when during their interaction with healthcare
those patients most often develop sepsis. This important work will
identify strategies for enhancing primary diagnosis prevention for
those patients identified with severe sepsis.
Adding to the body of knowledge about sepsis, researchers at CDC's
Harvard Prevention Epi-Center are working to better understand ways to
identify patients most likely to benefit from a set of specific
interventions (called a ``bundle'') for treating severe sepsis. The
goal of this project is to focus resources, reduce unnecessary
antibiotic use, improve performance measurement, and improve tracking
of national risk-adjusted mortality. Meanwhile, researchers at CDC's
Washington University Prevention Epi-Center are tracking historic rates
of sepsis defined by both electronic health records and administrative
coding (billing) data. While most recent reports of increasing rates of
sepsis have been based upon billing data, such a comparison may reveal
findings suggesting that while U.S. hospitals are doing a better job at
diagnosing and coding for sepsis (and therefore show an increase in
billing codes for sepsis), actual rates of sepsis defined via clinical
parameters have remained stable.
The United States and European Union (E.U.) continue to consult
with each other regarding best practices for diagnosing and monitoring
sepsis. This is principally done as part of the ongoing activities of
the Transatlantic Task Force on Antimicrobial Resistance (TATFAR). In
implementing the recommendations for collaboration in the initial
TATFAR report,\3\ the United States and E.U. have addressed the issue
of sepsis diagnostics and monitoring. Specifically, the United States
and E.U. held a joint workshop entitled, ``Challenges and Solutions in
the Development of New Diagnostic Tests to Combat Antimicrobial
Resistance'' in September 2011, Brussels, Belgium. The workshop brought
together experts from healthcare, government, and industry with an aim
to identify factors impacting the development, approval, introduction
and appropriate use of new diagnostic tools for invasive bacterial
infections (i.e., sepsis) in both inpatient and outpatient settings. In
addition, the U.S. CDC and the E.U. CDC (ECDC) regularly correspond on
the topic of antimicrobial resistant surveillance activities and
results including surveillance for pathogens causing sepsis and
associated antimicrobial resistance. CDC and ECDC conduct quarterly
conference calls to discuss surveillance strategies, new findings and
trends.
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\3\ http://www.cdc.gov/drugresistance/pdf/tatfar-report.pdf.
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Timely transatlantic communication and common actions are
fundamental to respond to emerging threats and critical trends due to
antimicrobial resistance. To improve communication and properly
disseminate information within the United States, E.U. and partner
public health agencies and ministries of health, CDC and ECDC drafted
and approved terms of reference (ToR) on how international
communication and actions about critical antimicrobial resistance
surveillance results will occur and what information should be
communicated. As described in the ToR, communications include a
procedure for notification of the identification of novel resistant
phenotypes, as well as quarterly conference calls in which CDC and ECDC
subject matter experts discuss new resistance data and critical trends.
These calls were initiated in 2012 and allow experts to exchange
information on resistance and also on surveillance programs and
protocols. As a result, each agency has gained better insight into the
current state of antimicrobial resistance and is fostering new
collaborations.
Finally, the question regarding being sure that patients who need
antibiotics receive them early on while avoiding unnecessary antibiotic
use highlights a concern we share. Currently, empiric antibiotics
(i.e., non-prophylaxis and non-culture directed or therapeutic) account
for a significant proportion of all antibiotics administered in U.S.
hospitals and such early empiric use is necessary to reduce mortality
from serious infections in individual situations. In light of this
necessity, our principal antibiotic stewardship strategies to improve
antibiotic use do not involve restrictions on such early empiric use,
but rather encourage clinicians to communicate in the medical record
why the antibiotics are being used and perform an ``antibiotic time
out'' after 48-72 hours when culture results become available,
reassessing whether the antibiotics are still needed. To advance the
availability of tools to aid in clinical decisionmaking, both CDC's
Chicago and University of Pennsylvania Prevention Epicenters are
performing research on biomarkers, such as procalcitonin, that can
assist in determining whether a patient requires, or continues to
require, antibiotic coverage owing to a higher likelihood of active
infection.
Question 5. What else is the CDC doing to help hospitals deal with
infections that are resistant to antibiotics?
Question 6. How is the CDC keeping up with diseases to ensure they
are not becoming resistant to antibiotics?
Answers 5-6. Preventing infections negates the need for antibiotic
use in the first place, and scientific evidence shows that reducing
antibiotic use in a single facility can reduce resistance in that
facility. Taken on a national scale, infection prevention efforts can
significantly decrease resistance. To help prevent infections, CDC:
conducts research to find new ways of preventing
infections;
provides the Nation with infection prevention guidelines
and tools to prevent infections;
serves as the Nation's reference laboratory to identify
microorganisms; and
offers the Nation's largest HAI infection tracking system,
the National Healthcare Safety Network (NHSN), allowing facilities and
States to identify and address problem areas.
CDC works to prevent antibiotic resistance in healthcare settings
by providing a system to track resistance and prescribing patterns at
national, regional, and local levels; providing guidance to healthcare
facilities interested in better antibiotic use; and working to prevent
all patient infections through infection control guidelines, assistance
implementing these guidelines, and laboratory expertise. As more
hospitals submit data to the new NHSN Antibiotic Use and Resistance
(AUR) Module, they will be able to track and benchmark antibiotic
resistance in all bacteria, as well as track antibiotic usage. CDC's
NHSN is used by healthcare facilities to electronically report
infections, antibiotic use, and resistance. Data currently submitted by
hospitals to NHSN provide facilities, States, and regions with the
ability to track and benchmark antibiotic resistance (AR) in bacteria
responsible for many HAI. This information will allow facilities to
target areas of concern, to make needed improvements and to track the
success of their efforts. In addition, NHSN allows CDC to perform and
report national assessments of antibiotic resistance.
CDC uses national, regional, and local surveillance data to: (1)
detect and track emerging AR pathogens; (2) identify situations where
multidrug resistant pathogens are increasing; and (3) work with State
health department and healthcare facilities to prevent infections and
respond to outbreaks of antibiotic resistance. Under the Prevention
Fund, CDC has piloted regional collaborative projects to detect
emerging AR problems and implement infection control measures to
prevent spread of AR pathogens. CDC works with State public health
departments to improve and strengthen their clinical and public health
laboratories to detect AR pathogens accurately.
CDC's EIP and Epidemiology and Laboratory Capacity collaborate with
State and national partners on AR surveillance and special studies for
invasive Methicillin-
resistant Staphylococcus aureus (MRSA) and multidrug-resistant, gram-
negative organisms.
CDC laboratories detect new and emerging pathogens (e.g., by using
DNA analysis) to compare and maintain a repository of clinically
relevant isolates. CDC's specialized national reference laboratory
tests bacteria samples from around the country to detect new and
emerging resistance patterns that affect patient health. This provides
an early warning of new resistance that has the potential to spread
across the Nation, requiring public health action. Additionally, CDC
recently conducted a survey in collaboration with EIP sites to estimate
the number of HAIs and to better understand antibiotic use in U.S.
hospitals. This is CDC's largest EIP survey in more than 30 years and
will make improved estimates of the burden of HAIs in the United
States, discover which pathogens are causing infections and how many
are resistant to antibiotics, and identify antibiotic use patterns that
may be contributing to resistance. The survey will complement NHSN data
by addressing all HAIs in all types of hospital patients and will be
used to inform national policies and recommendations that target HAI
prevention and antibiotic preservation. Two publications will be
released on the results of this survey. The first will focus on the HAI
prevalence and the second will focus on results related to antibiotic
use. Formal results will be published in spring 2014 and late 2014
respectively.
senator hagan
Question. Despite the important work done by a variety of health
care providers, published reports indicate that some continue to be
exposed to blood-borne pathogens and bacterial infections due to unsafe
medical injection practices including the reuse of needles and/or
syringes, mishandling of medication vials and containers, reuse of
single-dose vials, and reuse of insulin pens. The CDC has clear
guidelines for are injection practices. Last summer, the GAO shed light
on this issue in their report ``HHS Has Taken Steps to Address Unsafe
Injection Practices, but More Action Is Needed.'' This report noted the
work of the CDC to promote education and awareness on this topic.
However, this report focused solely on unsafe injection practices in
ambulatory surgery centers (ASCs). But we know that unsafe medical
injections are happening in other settings as well such as VA Medical
Centers, assisted living facilities, dental clinics, correctional
facilities, and inpatient hospitals.
What steps need to be taken to ensure that all healthcare providers
are aware of and adhering to current injection safety guidelines across
all healthcare settings?
Answer. Investigations undertaken by State and local health
departments and the CDC have identified instances of improper use of
syringes, needles, and medication vials during routine healthcare
procedures, such as administering injections. These unsafe practices
have resulted in a wide range of adverse events, including the
transmission of bloodborne viruses, like hepatitis C, to patients.
Between 2001 and 2011, over 40 outbreaks of viral hepatitis or
bacterial infections resulting from unsafe injection practices occurred
in various healthcare settings, most commonly in non-hospital settings.
These outbreaks resulted in the notification and infection testing of
over 130,000 patients and over 630 confirmed infections. It should be
noted that these numbers are likely to be an under-estimate due to
inherent challenges with outbreak detection and investigation. These
unfortunate events serve as a reminder of the serious consequences of
failure to maintain strict adherence to safe injection practices during
patient care. Injection safety and other basic infection control
practices are central to patient safety, as well as prevention of
needle-stick injuries to providers and other healthcare personnel.
CDC is working with partners, other Federal agencies, and State and
local health departments to provide educational and promotional
materials in an effort to improve adherence to CDC safe injection
practices and prevent transmission of bloodborne pathogens and other
infectious diseases in all healthcare settings. CDC and the Healthcare
Infection Control Practices Advisory Committee (HICPAC) developed
evidence-based recommendations on Safe Injection Practices applicable
in all healthcare settings as part of Standard Precautions and can be
found in the 2007 Guideline for Isolation Precautions. CDC and HICPAC
further developed guidelines specifically targeting infection control
practices in outpatient healthcare settings, including those related to
safe injection practices. CDC is collaborating with the Safe Injection
Practices Coalition (SIPC) on the One and Only Campaign, an educational
campaign to promote safe injection practices by raising awareness among
patients and healthcare providers about safe injection practices.
Currently CDC and SIPC have partnered with five States (CO, NC, NJ, NV,
and NY) to help disseminate the messages and materials of the One &
Only Campaign, conducting educational outreach, state-based activities
and further promotion of the campaign.
CDC continues to respond to a steadily increasing number of
requests from State health departments and healthcare facilities for
assistance in investigating infections and outbreaks potentially
stemming from unsafe injection practices or related breakdowns in safe
care. Support from CDC includes technical guidance and consulting from
epidemiologists, onsite assistance with field investigations, and
laboratory assistance. Varying availability of health department
resources and potential reticence by health departments and facilities
to alert CDC of potential outbreaks continue to affect CDC's ability to
accurately and effectively monitor unsafe injection practices and
related adverse events.
senator murphy
Question. To date, efforts to address antibiotic resistance have
been primarily focused on encouraging the development of new
antibiotics. CDC's recent report also identifies the need to develop
new diagnostic tests for identifying resistant bacteria. What steps do
we need to take to encourage investments in research and development in
order to advance diagnostic capabilities in this area?
Answer. CDC recommends four core actions to address the public
health concern of antibiotic resistance:
1. Prevent infections in the first place and stop the spread of
resistant infections from person-to-person.
2. Track resistance to monitor progress.
3. Improve antibiotic use/stewardship.
4. Develop new drugs and diagnostic tests.
CDC is the primary reference laboratory supporting State health
departments and U.S. health care facilities in timely identifying
dangerous or emerging antimicrobial resistance.
Given the scope of the threats that we face, CDC needs to equip our
scientists and State public health laboratories with the best available
tools to rapidly identify these threats and accelerate our Nation's
response to them. New technologies will allow us to uncover hidden
outbreaks (including those caused by antimicrobial resistant
pathogens), stop them sooner, and save lives. To that end, the
President's fiscal year 2014 Budget proposed an Advanced Molecular
Detection (AMD) initiative that would equip CDC's scientists with two
powerful technologies--molecular sequencing and bioinformatics--to help
solve complex disease outbreaks. With new technology CDC can find
outbreaks we are currently missing, find outbreaks sooner, stop them
faster, and identify ways organisms are spread so we can better prevent
them. These techniques would also help us to identify how pathogens
spread so we can better target our prevention efforts. Genetic
sequencing of pathogens, if funded, will revolutionize how CDC
investigates and controls disease outbreaks, including those caused by
antibiotic resistant strains.
This funding will support research designed to improve our
understanding of the molecular mechanisms of resistance and will
support the development of new clinical diagnostic tests to detect AR
pathogens to improve clinical decisionmaking and speed up the
implementation of infection control strategies. These investments will
allow CDC to: lead core laboratory activities to assess optimal patient
treatment; serve as a national and international antimicrobial
resistance reference laboratory; perform antimicrobial susceptibility
tests; and respond to diagnostic needs for new and emerging healthcare-
associated pathogens.
Specifically, culture-based laboratory diagnostics are slow and
insensitive. Polymerase-chain-reaction-based tests are costly and
provide limited information. AMD will enable CDC to establish leading
capability to adapt the next generation of rapid, semi-automated,
point-of-care molecular tests to meet evolving public health needs. As
a result, the agency will significantly enhance its ability to pinpoint
early threats and outbreaks; develop new diagnostic tests during
outbreaks; better characterize infections, including those caused by
highly resistant healthcare-associated pathogens, such as Clostridium
difficile, MRSA, and CRE; and increase the level of detail and quality
of information for biosurveillance and response activities. To that
end, the President's fiscal year 2014 budget proposal is an important
step in helping to ensure that CDC can adequately track, rapidly
detect, and respond to these alarming threats.
Response by Jonathan Perlin, M.D. Ph.D., MSHA, FACP, FACMI to Question
of Senator Casey
Question. The REDUCE MRSA study specifically looked at strategies
to reduce transmission of MRSA. Are there any similar efforts underway
to better identify and treat sepsis?
Answer. We are advancing up our own version of the national
``Survive Sepsis'' campaign. That said, the state-of-the-art doesn't
yet allow early identification of when sepsis will occur. We propose
that collaboration with CDC and academic colleagues could allow us to
mine ``big data'' to discover earlier predictors of sepsis.
As I testified, current science allows us to intervene aggressively
when we see fire. We need to be able to smell smoke, or even advance to
preventing fires.
I am happy to discuss or elaborate further. Again, my thanks to the
committee for the privilege of presenting our work and for their
leadership in this important area.
[Whereupon, at 12 p.m., the hearing was adjourned.]
[all]