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[Senate Hearing 113-812]
[From the U.S. Government Publishing Office]

                                                        S. Hrg. 113-812

        U.S. EFFORTS TO REDUCE HEALTHCARE-ASSOCIATED INFECTIONS

=======================================================================

                                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

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions

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                          Washington, DC 20402-0001

          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.
---------------------------------------------------------------------------
    \1\ http://www.cdc.gov/hai/burden.html.
    \2\ http://www.psnet.ahrq.gov/primer.aspx?primerID=7.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \3\ http://www.hhs.gov/ash/initiatives/hai/actionplan/.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \6\ For more information on the Hospital Compare Web site please 
visit: http://www.medicare.
gov/hospitalcompare.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \10\ Details about each of these projects is available at http://
www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/QualityImprovementOrgs/Current.html.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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/.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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:
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
     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.
---------------------------------------------------------------------------
    \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/.
---------------------------------------------------------------------------
     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.
---------------------------------------------------------------------------
    \16\ Antibiotic Resistant Threats in the United States, 2013: 
http://www.cdc.gov/drug
resistance/threat-report-2013/.
---------------------------------------------------------------------------
     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.
---------------------------------------------------------------------------
    \17\ Antibiotic Resistant Threats in the United States, 2013; 
http://www.cdc.gov/drug
resistance/threat-report-2013/.
---------------------------------------------------------------------------
     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.
---------------------------------------------------------------------------
    \18\ National Burden of Invasive Methicillin-Resistant 
Staphylococcus aureus Infections, United States, 2011.
---------------------------------------------------------------------------
     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.
---------------------------------------------------------------------------
    \19\ Antibiotic Resistant Threats in the United States, 2013: 
http://www.cdc.gov/drug
resistance/threat-report-2013/.
---------------------------------------------------------------------------
     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.
---------------------------------------------------------------------------
    \20\ Antibiotic Resistant Threats in the United States, 2013: 
http://www.cdc.gov/drug
resistance/threat-report-2013/.
---------------------------------------------------------------------------
         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\
---------------------------------------------------------------------------
    \21\ Pending publication, unpublished data currently under peer 
review.
    \22\ Pending publication, unpublished data currently under peer 
review.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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\;
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
     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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \27\ EIP-HAI projects: http://www.cdc.gov/hai/eip/.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \28\ National Action Plan to Prevent Health Care-Associated 
Infections: Road Map to Elimination: http://www.hhs.gov/ash/
initiatives/hai/actionplan/index.html.
---------------------------------------------------------------------------
       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.
---------------------------------------------------------------------------
    \29\ http://www.cdc.gov/amd/.
---------------------------------------------------------------------------
      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.
---------------------------------------------------------------------------
    \30\ http://www.nejm.org/doi/pdf/10.1056/NEJMoa1207290.
---------------------------------------------------------------------------
   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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \34\ HAI coordinators were recently named White House Champions for 
Change: Marion Kainer (TN) and Erica Washington (LA): http://
www.whitehouse.gov/champions.
---------------------------------------------------------------------------
                           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\
---------------------------------------------------------------------------
    \35\ Detect and Protect: http://www.cdc.gov/hai/pdfs/cre/
CDC_DetectProtect.pdf.
---------------------------------------------------------------------------
    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 59" 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.
---------------------------------------------------------------------------
    \1\ http://w3.health.state.ny.us/dbspace/propregs.nsf/
4ac9558781006774852569bd00512fda/4774b2c3cb19d1a385257b02005e2fdb.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \2\ http://www.theguardian.com/society/2013/sep/12/nhs-patients-
dying-sepsis-care-failings.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
                              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]
```