[Senate Hearing 113-787]
[From the U.S. Government Publishing Office]




                                                        S. Hrg. 113-787

   MORE THAN 1,000 PREVENTABLE DEATHS A DAY IS TOO MANY: THE NEED TO 
                                IMPROVE 
                             PATIENT SAFETY

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

                                HEARING

                               BEFORE THE

                SUBCOMMITTEE ON PRIMARY HEALTH AND AGING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                    ONE HUNDRED THIRTEENTH CONGRESS

                             SECOND SESSION

                                   ON

  EXAMINING THE NEED TO IMPROVE PATIENT SAFETY AND REDUCE PREVENTABLE 
                                 DEATHS

                               __________

                             JULY 17, 2014

                               __________

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


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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                       TOM HARKIN, Iowa, Chairman

BARBARA A. MIKULSKI, Maryland		LAMAR ALEXANDER, Tennessee
PATTY MURRAY, Washington		MICHAEL B. ENZI, Wyoming
BERNARD SANDERS (I), Vermont		RICHARD BURR, North Carolina
ROBERT P. CASEY, JR., Pennsylvania	JOHNNY ISAKSON, Georgia
KAY R. HAGAN, North Carolina		RAND PAUL, Kentucky
AL FRANKEN, Minnesota			ORRIN G. HATCH, Utah
MICHAEL F. BENNET, Colorado		PAT ROBERTS, Kansas
SHELDON WHITEHOUSE, Rhode Island	LISA MURKOWSKI, Alaska
TAMMY BALDWIN, Wisconsin		MARK KIRK, Illinois
CHRISTOPHER S. MURPHY, Connecticut	TIM SCOTT, South Carolina
ELIZABETH WARREN, Massachusetts

                      Derek Miller, Staff Director

        Lauren McFerran, Deputy Staff Director and Chief Counsel

               David P. Cleary, Republican Staff Director

                                 ______

                Subcommittee on Primary Health and Aging

                 BERNARD SANDERS (I), Vermont, Chairman

BARBARA A. MIKULSKI, Maryland        RICHARD BURR, North Carolina
KAY R. HAGAN, North Carolina         PAT ROBERTS, Kansas
SHELDON WHITEHOUSE, Rhode Island     LISA MURKOWSKI, Alaska
TAMMY BALDWIN, Wisconsin             MICHAEL B. ENZI, Wyoming
CHRISTOPHER S. MURPHY, Connecticut   MARK KIRK, Illinois
ELIZABETH WARREN, Massachusetts      LAMAR ALEXANDER, Tennessee (ex 
TOM HARKIN (Iowa (ex officio)        officio)

                     Sophie Kasimow, Staff Director

               Kristen Chapman, Republican Staff Director

                                  (ii)

 

                            C O N T E N T S

                               __________

                               STATEMENTS

                        THURSDAY, JULY 17, 2014

                                                                   Page

                           Committee Members

Sanders, Hon. Bernard, Chairman, Subcommittee on Primary Health 
  and Aging, opening statement...................................     1
Warren, Hon. Elizabeth, a U.S. Senator from the State of 
  Massachusetts..................................................     2
Whitehouse, Hon. Sheldon, a U.S. Senator from the State of Rhode 
  Island.........................................................     2

                               Witnesses

James, John T., Ph.D., Founder, Patient Safety America, Houston, 
  TX.............................................................     3
    Prepared statement...........................................     5
Jha, Ashish K., M.D., MPH, Professor of Health Policy and 
  Management, Harvard school of Public Health, Boston, MA........     7
    Prepared statement...........................................     9
Gandhi, Tejal K., M.D., MPH, CPPS, President, National Patient 
  Safety Foundation; Associate Professor of Medicine, Harvard 
  Medical School, Boston, MA.....................................    15
    Prepared statement...........................................    17
Pronovost, Peter, M.D., Ph.D., FCCM, Senior Vice President for 
  Patient Safety and Quality and Director of the Armstrong 
  Institute for Patient Safety and Quality, Johns Hopkins 
  Medicine, Baltimore, MD........................................    19
    Prepared statement...........................................    21
Disch, Joanne, Ph.D., RN, FAAN, Professor ad Honorem, University 
  of Minnesota School of Nursing, Minneapolis, MN................    25
    Prepared statement...........................................    27
McGiffert, Lisa, Director, Safe Patient Project, Consumers Union, 
  Austin, TX.....................................................    34
    Prepared statement...........................................    36

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.:
    Senator Barbara Boxer, Report on Medical Errors..............    57
    Response to questions of Senator Warren by Peter Pronovost, 
      M.D., Ph.D., FCCM..........................................    65

                                 (iii)

  

 
   MORE THAN 1,000 PREVENTABLE DEATHS A DAY IS TOO MANY: THE NEED TO 
                         IMPROVE PATIENT SAFETY

                              ----------                              


                        THURSDAY, JULY 17, 2014

                                       U.S. Senate,
                  Subcommittee on Primary Health and Aging,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 10:02 a.m., in 
room SD-430, Dirksen Senate Office Building, Hon. Bernard 
Sanders, chairman of the subcommittee, presiding.
    Present: Senators Sanders, Whitehouse, Murphy, and Warren.

                  Opening Statement of Senator Sanders

    Senator Sanders. Let me begin by thanking all of our 
distinguished panelists for being with us this morning. In a 
sense, the discussion we're going to have today is personal, I 
think, for people all over this country in the sense that many 
of us, myself included, have seen folks go into a hospital for 
one problem or another and end up coming out a lot sicker than 
when they went in and, in some cases, dying as a result.
    What is widely known is that the major cause of death in 
the United States today is heart disease, a serious problem. 
The second leading cause of death is cancer. According to the 
2010 CDC report, more than 597,000 people died of heart disease 
and 574,000 died of cancer.
    But what is not widely known and, in fact, what this 
hearing is about--and I hope to do my best with the help of my 
fellow Senators and members of this panel--is to start focusing 
attention on the third leading cause of death in the United 
States of America, and that will come as a great surprise to 
most people. The third leading cause of death in this country 
has to do with preventable medical errors in hospitals.
    A recent article published in the Journal of Patient Safety 
estimates that as many as 440,000 people a year may die from 
preventable medical errors in hospitals--440,000 a year. That 
could be more than 1,000 a day. Tens of thousands also die from 
preventable mistakes outside the hospital, such as deaths from 
misdiagnoses or injuries from medications.
    Nearly 15 years ago, the Institute of Medicine published a 
report--it is a well-publicized report--entitled, ``To Err is 
Human,'' which found that as many as 98,000 people die in 
hospitals each year due to preventable medical errors. 
According to a 2010 report, a more recent report, from the 
Department of Health and Human Services, 180,000 Medicare 
patients alone, just Medicare patients, die from preventable 
adverse events in hospitals.
    According to the CDC, 1 in 25 hospital patients gets an 
infection from being in the hospital. In 2011, these hospital-
acquired infections caused 700,000 people to get sick and 
75,000 people to die.
    Clearly, these errors cause an immense amount of human 
suffering. But they are also--from a financial point of view--
very, very expensive to the government and to individual 
families. Medical errors cost the U.S. healthcare system more 
than $17 billion in 2008, and when indirect costs are taken 
into account, such as lost productivity due to missed work 
days, medical errors may cost nearly $1 trillion each year.
    Now, in the midst of this situation, which we will be 
discussing today--and I think we agree, it's not just an 
American issue. This is an issue that's taking place all over 
the world. Countries' healthcare systems all over the world are 
trying to combat it. The good news is that there has been 
progress made in recent years. We're going to hear from our 
panelists about the kinds of progress that has been made and, 
more importantly, where we have to go.
    I think the horror here is that we all understand that 
tragedies occur. People die for all kinds of reasons. But the 
tragedy that we're talking about here are deaths taking place 
that should not be taking place, and that's what we are going 
to be focusing on.
    Some of the advances that we have seen--and we'll be 
discussing these this morning--come from following practices, 
interestingly enough, that have been established in other high-
stakes fields like aviation and nuclear safety by people who 
are obviously dealing with very dangerous situations. For 
example, through the implementation of checklists, infection 
rates in our country have dropped dramatically. Advances in 
technology, such as electronic prescrib-
ing, can catch medication errors, and robotic tools, which 
create smaller incisions during surgery, can reduce the risk of 
an infection.
    Further, there has been increased attention to something 
that seems pretty obvious, the need to wash hands on a regular 
basis in hospitals. One would assume that would be pretty 
obvious.
    Medical harm in this country is a major cause of suffering, 
disability, and death, as well as a huge financial cost to our 
Nation. This is a problem that has not received anywhere near 
the attention that it deserves. Today, I hope we can begin the 
process of focusing a spotlight on this matter of such grave 
consequence.
    Senator Warren.

                      Statement of Senator Warren

    Senator Warren. Mr. Chairman, I don't have an opening 
statement. I'm eager to get to the testimony and to the 
questions.
    Senator Sanders. Senator Whitehouse.

                    Statement of Senator Whitehouse

    Senator Whitehouse. Thank you, Chairman, very much for 
holding this hearing, and I want to thank Chairman Harkin for 
allowing this to go forward, because this is really an 
extraordinarily important issue.
    For all the work and all the fuss and all the fighting that 
has surrounded the Affordable Care Act, there remains a very 
large fundamental problem in the American healthcare system, 
which is that it costs about 50 percent more than the most 
inefficient other industrialized countries' healthcare systems 
in the world. We have an inefficiency premium of about 50 
percent over the major economies that we compete with. The 
price of that inefficiency is paid also in hundreds of 
thousands of American lives. For all the good that the 
Affordable Care Act did, those two problems remain before us.
    I am delighted to be here. I, in particular, want to 
welcome Dr. Pronovost. We have never met before, but he is the 
architect of what many years ago was called the Keystone 
Project in Michigan, and I established----
    Senator Sanders. That's a different Keystone Project.
    Senator Whitehouse. A different Keystone Project.
    [Laughter.]
    Senator Sanders. I want to make it clear.
    Senator Whitehouse. And many years ago, I established 
something in Rhode Island called the Rhode Island Quality 
Institute, which took the Keystone-Pronovost principles and 
applied it in our intensive care units and dramatically reduced 
the hospital-acquired infections in our intensive care units. 
Interestingly, it also had the side effect of making the 
nursing staff in the intensive care units empowered enough that 
nursing turnover experienced a considerable drop-off, because 
they were so excited about what they were doing.
    So there are wonderful ways that we can do this. Obviously, 
when you're talking about saving people's lives, saving money 
is a secondary concern. But here, we have a very fortuitous 
alignment between saving lives and saving money. This is a very 
important topic, and I applaud you for having brought this 
wonderful group of witnesses together and for holding this 
hearing.
    Thank you.
    Senator Sanders. Thank you very much, Senator Whitehouse.
    OK. Let's get to work. Dr. John James is the Founder--what 
I'm going to do is just introduce you, and you'll go, and then 
we'll go on down the line.
    Dr. John James is the Founder of Patient Safety America. In 
September 2013, Dr. James published an article in the Journal 
of Patient Safety which found that somewhere between 210,000 
and 440,000 Americans die each year from preventable medical 
harm in the hospital. Dr. James retired in early 2014 as NASA's 
chief toxicologist. He received his Ph.D. in pathology from the 
University of Maryland.
    Dr. James, thanks very much for being with us.

  STATEMENT OF JOHN T. JAMES, Ph.D., FOUNDER, PATIENT SAFETY 
                      AMERICA, HOUSTON, TX

    Mr. James. The counter didn't start. Who starts the 
counter?
    Senator Sanders. This is not NASA. We don't have to--5,4. 
All right. We'll start the count. This is a NASA guy. OK.
    Mr. James. I thank Chairman Sanders for inviting me to 
testify about patient safety. I speak today on behalf of 
hundreds of thousands of Americans whose voices have been 
silenced forever by preventable adverse medical events.
    By way of background, the seminal event that turned me into 
a patient safety activist occurred in the late summer of 2002. 
My son Alex was 19 years old and had returned for his junior 
year at Baylor University. While running in the evening of 
August 20th, he collapsed on the university campus, self-
recovered, but was taken to a local hospital.
    He was evaluated there for 4 days by cardiologists and 
underwent an electrophysiology test at another hospital. Five 
days after his discharge, he had a followup visit with a 
physician-in-training who gave him a clean bill of health. In a 
week, he returned to running.
    On September 15th, approximately 2 weeks after he resumed 
running, I received a call late in the evening that he had 
collapsed again while running, but this time his heart had 
stopped and he was in a deep, unresponsive coma. He died 3 days 
later in the hospital where he was first taken for evaluation. 
Once I was able to get his medical records, I discovered that 
my suspicions about the cause of his death were borne out.
    During his first hospitalization, I had noted to his lead 
cardiologist that his potassium was low and this might have 
been the cause of his initial collapse. He discounted this 
possibility, and so potassium replacement was never 
administered. In fact, as I deduced much later, at least three 
catastrophic errors were made by his doctors: (1) they failed 
to apply a guideline from the National Council on Potassium in 
Clinical Practice, (2) they failed to diagnose acquired long QT 
syndrome, and (3) they knew he should not return to running, 
wrote this in his medical record, but never warned him not to 
run. Alex's only discharge instructions in writing were not to 
drive for 24 hours.
    I've written about the details of his poor-quality care in 
a book that I published in 2007. Many physicians have read that 
book and none have disputed my analysis. In fact, an 
electrophysiologist, after reading my book, affirmed to me in 
an e-mail that she too had been frustrated in attempts to get 
her cardiologist colleagues to pay more attention to potassium. 
Apparently, I gained a measure of credibility in the cardiology 
community, because in the past few years, I have completed 25 
invited reviews of cardiology manuscripts for a cardiology 
journal.
    As I unraveled the errors made in my son's care, and then 
discovered that his cardiac MRI was never done properly, I 
began to realize that medical errors like those that ended his 
life were not uncommon. I saw that the Institute of Medicine 
had estimated that up to 98,000 Americans die each year from 
medical errors in hospitals. Other reputable estimates at that 
time were as high as 284,000 deaths. Remarkably, if the harmed 
patient does survive, then, with few exceptions, the hospital 
will be paid to fix the harm.
    So how much harm is there, really? By 2011, I had noticed 
four new studies that had used the Global Trigger Tool to 
identify adverse events in medical records. Two were peer-
reviewed studies, and two were from the Office of the Inspector 
General. This tool was much more efficient at identifying 
adverse events than unguided physician reviews.
    I noted that the individual studies gave a remarkably 
consistent picture of the prevalence of lethal adverse events. 
In addition, other studies had been published showing that 
medical records often do not contain evidence that is 
discoverable of harm even when the patients know they were 
seriously harmed.
    In 2013, I published the study in the Journal of Patient 
Safety. The math behind my calculation is rather simple. 
There's no voo-doo statistics here. There were 34 million 
hospitalizations in 2007, of which approximately 0.9 percent 
involved lethal adverse events, and of those, approximately 69 
percent, on average, were judged to be preventable. This yields 
an estimate of 210,000.
    However, the Global Trigger Tool, while good at detecting 
errors of commission, misses many errors of omission, 
communication, context, and diagnosis. It would not have 
detected any of the catastrophic errors made by my son's 
doctors. Furthermore, it misses events for which no evidence 
appears in the medical record. Correcting for these limitations 
yields an estimate that more than 400,000 lives are shortened 
by preventable adverse events each year.
    What are the solutions? No. 1, the Senate should establish 
a standalone committee on improving patient safety. No. 2, it 
should establish a National Patient Safety Board. And No. 3, it 
should pass a national patients' bill of rights to include 
legally defined and enforced rights to give genuinely informed 
consent; to know the safety record of their physician, 
outpatient clinic, nursing home, and hospital; to know costs 
for tests and elective procedures beforehand; to transparent 
accountability; to evidence-based care; to know when drugs are 
prescribed off-label; to be warned about bad lifestyle choices; 
to have care by teams of professionals that build individual 
and team excellence through 360-degree performance reviews. 
These are anonymous reviews by patients, subordinates, 
colleagues, and leaders--anonymously.
    In my opinion, patient safety is not going to improve 
substantially until the playing field between the ill patient 
and the healthcare industry is leveled by an enforced bill of 
rights. Despite our high per capita expenditures on healthcare, 
our industry ranks last overall when compared to systems in 
other developed countries. Please, that needs to change.
    I thank you for your attention.
    [The prepared statement of Mr. James follows:]
               Prepared Statement of John T. James, Ph.D.
    I thank Chairman Sanders for inviting me to testify about patient 
safety. I speak today on behalf of hundreds of thousands of Americans 
whose voices have been silenced forever by preventable adverse medical 
events.
    Background: The seminal event that turned me into a patient safety 
activist occurred in the late summer of 2002. My son Alex was 19 years 
old and had returned for his junior year at Baylor University. While 
running in the evening of August 20th he collapsed on the university 
campus, self-recovered, but was taken to a local hospital. He was 
evaluated there for 4 days by cardiologists and underwent an 
electrophysiology test at another hospital in Waco. Five days after 
discharge he had a followup visit with a physician-in-training who gave 
him a clean bill of health. In a week he returned to running. On 
September 15th, approximately 2 weeks after he resumed running, I 
received a call late in the evening that he had collapsed again while 
running, but this time his heart had stopped and he was in a deep, 
unresponsive coma. He died 3 days later in the hospital where he was 
first taken for evaluation.
    Once I was able to get his medical records, I discovered that my 
suspicions about the cause of his death were borne out. During his 
first hospitalization, I had noted to his lead cardiologist that his 
potassium was low and this might have been the cause of his initial 
collapse. He discounted this possibility, and so potassium replacement 
was never administered. In fact, as I deduced much later, at least 
three catastrophic errors were made by his doctors: (1) they failed to 
apply a guideline from the National Council on Potassium in Clinical 
Practice, calling for potassium replacement if heart arrhythmias are 
present, (2) they failed to diagnose acquired long QT syndrome, and (3) 
they knew he should not return to running, wrote this in his medical 
record, but never warned him not to run; Alex's only discharge 
instructions were not to drive for 24 hours.
    I have written about the details of his poor-quality care in a book 
that I published in 2007. Many physicians have read my book and none 
have disputed my analysis. In fact an electrophysiologist, after 
reading my book affirmed to me in an e-mail that she too has been 
frustrated in attempts to get her cardiologist colleagues to pay more 
attention to potassium. Apparently, I gained a measure of credibility 
in the cardiology community because in the past few years I have 
completed 25 invited reviews of cardiology manuscripts for a cardiology 
journal.
    As I unraveled the errors made in my son's care, and then 
discovered that his cardiac MRI was never done properly, I began to 
realize that medical errors like those that ended his life were not 
uncommon. I saw that the Institute of Medicine, had estimated that up 
to 98,000 Americans die each year from medical errors. Other reputable 
estimates at that time were as high as 284,000. If the harmed patient 
survives, then, with few exceptions, the hospital will be paid to fix 
the error.
    Estimating Harm: By 2011 I had noticed four new studies that had 
used the Global Trigger Tool to identify adverse events in medical 
records. Two were peer-reviewed studies published in medical journals, 
and two were from the Office of the Inspector General. This tool was 
much more efficient at identifying adverse events than unguided 
physician reviews. I noted that the individual studies gave a 
remarkably consistent picture of the prevalence of lethal adverse 
events. In addition, other studies had been published showing that 
medical records often do not contain discoverable evidence of serious 
patient harm even when the patients know they were seriously harmed. In 
2013 the Journal of Patient Safety published my study on the prevalence 
of preventable adverse events in hospitals. It has been supported by 
leading doctors in the patient safety community.
    The math behind my calculation is rather simple. There were 34 
million hospitalizations in 2007 of which approximately 0.9 percent 
involved lethal adverse events, and of those approximately 69 percent 
on average were judged to be preventable. This yields an estimate of 
210,000; however, the trigger tool, while good at detecting errors of 
commission, misses many errors of omission, communication, context, and 
diagnosis. It would not have detected any of the catastrophic errors 
made by my son's doctors. Furthermore, it misses events for which no 
evidence appears in the medical record. Correcting for these 
limitations yields an estimate that more than 400,000 lives are 
shortened by preventable adverse events each year.
    Proposed Solutions: The Senate should establish a stand-alone 
committee on improving patient safety. It should establish a National 
Patient Safety Board (like the National Transportation Safety Board) to 
investigate patient harm.
    Congress should also pass a national patients' bill of rights 
containing rights like those enjoyed by workers and minorities. The law 
must include the following rights for patients:

     Legally defined and enforced right to give genuinely 
informed consent.
     To know the safety record of their physician, outpatient 
clinic, nursing home, and hospital.
     To know costs for tests and elective procedures before 
hand.
     To transparent accountability in the case of an adverse 
event.
     To evidence-based care.
     To know when drugs are prescribed off-label.
     To be warned about bad lifestyle choices.
     To have an advocate present while hospitalized.
     To care by teams of professionals that build individual 
and team excellence through 360-degree performance reviews. These are 
anonymous reviews by patients, subordinates, colleagues, and leaders.

    Patient safety is not going to improve substantially until the 
``playing field'' between the ill patient and the healthcare industry 
is leveled by an enforced bill of rights. Despite our high per capita 
expenditures on healthcare, our industry ranks last overall when 
compared to systems in other developed countries.

    Senator Sanders. Thank you very much, Dr. James.
    Senator Warren, I think you were going to introduce our 
next panelist.
    Senator Warren. I am. I have the honor of introducing Dr. 
Ashish Jha. Dr. Jha is a Professor of Health Policy and 
Management at the Harvard School of Public Health. He is also a 
practicing physician of internal medicine at the Boston VA.
    Dr. Jha received his undergraduate degree from Columbia 
College and his medical degree and his master's degree in the 
master's of public health from Harvard University. Dr. Jha 
founded the Initiative on Global Health Quality at the Harvard 
School of Public Health, and his research focuses on improving 
the quality and reducing the cost of healthcare in the United 
States and around the world. In 2013, Dr. Jha was elected as a 
member of the Institute of Medicine. His work has been 
groundbreaking, and it is a great honor to have him here today.
    Thank you, Dr. Jha.
    Senator Sanders. Dr. Jha, thank you very much for being 
with us.

  STATEMENT OF ASHISH K. JHA, M.D., MPH, PROFESSOR OF HEALTH 
POLICY AND MANAGEMENT, HARVARD SCHOOL OF PUBLIC HEALTH, BOSTON, 
                               MA

    Dr. Jha. It's my pleasure. Thank you, Senator Sanders.
    And, Senator Warren, thank you for that very warm 
introduction.
    It has been 15 years since the IOM estimated that about 
100,000 Americans die each year from preventable medical 
errors. When they first came out with that number, it was so 
staggeringly large that most people wondered, ``Could it 
possibly be right?'' Fifteen years later in hindsight, evidence 
is in, and the evidence is very clear that the IOM probably got 
it wrong. It was clearly an underestimate of the toll of human 
suffering that goes on from preventable medical errors.
    Beyond the problem with the estimate and exactly how many 
people are suffering from these injuries, there's a second 
pressing question, which is it has been 15 years, and a 
reasonable person might ask, ``So how much progress have we 
made in the last 15 years? What have we done?'' You're going to 
hear from Dr. Pronovost and others about areas where I think we 
have had progress.
    But if the fundamental question is, ``If I walk into an 
American hospital today, am I demonstrably clearly safer than I 
would have been 15 years ago?'' the unfortunate answer is no. 
We have not moved the needle in any meaningful, demonstrable 
way overall. In certain areas, things are better. In certain 
areas, things are probably worse. But we are not substantially 
better off compared to where we were.
    The last sort of piece of distressing news in my mind is 
that, as Senator Sanders alluded to, I often am asked is this a 
uniquely American problem? Is this something that other 
countries struggle with? And when we have looked across the 
globe, what we find is no matter where you look, the size, the 
scope, the complexity of the problems are remarkably similar.
    The United States, when we compare ourselves with other 
high-income countries, is right in the middle of the pack. 
We're better in some areas, worse in others, but there is no 
country I can point to that I can say, ``They really get it 
right consistently.'' So I think there is a tremendous 
opportunity for leadership here.
    But beyond all that distressing stuff, let's talk a little 
bit about some of the progress that has been made. I want to 
begin by talking about preventable infections, because that is 
probably the place where we've made the greatest progress. When 
I talk about that topic, I usually point to two agents that I 
think have had a central role in reducing infections.
    One of them is the speaker two seats down from me, Dr. 
Pronovost. Peter's work has probably saved tens of thousands of 
lives, if not more. And I'm not going to talk about it, because 
he will do a much better job of explaining it.
    But the other agent worth talking about is the CDC through 
its surveillance programs. Its surveillance programs around 
healthcare associated infections have been, I think, 
fundamental to the improvement that we have seen. And the 
reason is if you take a step back and ask, ``How is it that we 
improve? How do we get better in anything in our lives?'' The 
key element in my mind is data and metrics that are valid and 
credible.
    If you don't have data and metrics, you don't know how 
you're doing, you don't know how you compare to anyone else, 
and you have no way to judge whether your efforts are making a 
difference or not. The CDC has been a leader in this area in 
helping develop validated metrics of infections and feeding 
that information back to hospitals. I think that has been 
fundamentally important in the kinds of improvements that we 
have seen.
    So here we are 15 years later, and the question we should 
ask ourselves is, ``How do we avoid another hearing 5 or 10 
years down the road, where we say, `oh, we're 25 years after 
the IOM report and we still have not made much progress?' '' 
None of us want to be at that hearing.
    So how do we avoid that? How do we begin to make real 
progress? I have three suggestions that I think are very 
doable. First is I think we need to expand the efforts of the 
CDC. There is no reason to think that what they have been able 
to do around healthcare associated infections, they can't do in 
other areas, such as venous thromboembolism, such as medication 
errors. They can partner with the FDA. The CDC has a phenomenal 
track record. This is a public health problem. The CDC is our 
public health agency. I think they have a central role to play.
    The second is around electronic health records. The country 
is in the midst of digitizing our records system. We have seen 
phenomenal progress in adoption and use of electronic health 
records. I think that has a lot of potential. But the potential 
is not going to be realized unless those tools are really 
focused on improving patient safety. The tools themselves won't 
automatically do it, and I think we need to make that a 
priority. There are very specific things the administration and 
Congress can do in that area.
    The third is around incentives. We can't continue to have 
unsafe medical care be a regular part of the way we do business 
in healthcare. Payers have a very important role to play. 
Medicare has a very important role to play. I think the ACA 
takes important steps in this area, but we can do so much more.
    To finish up, we have a cadre of physicians and nurses in 
this country who are incredibly well-trained, dedicated, caring 
individuals who go to work every day trying to do the best for 
their patients. We have a system that fails them, and we have a 
system that fails the patients who expect and really deserve 
healthcare that is not only effective but safe and improves 
their health, not harms it.
    Thank you very much.
    [The prepared statement of Dr. Jha follows:]
             Prepared Statement of Ashish K. Jha, M.D., MPH
    Chairman Sanders, Ranking Member Burr, and distinguished members of 
the subcommittee, thank you for inviting me to testify today. My name 
is Ashish Jha, and I am a professor at the Harvard School of Public 
Health in the Department of Health Policy and Management. I am also a 
practicing general internist at the VA Boston Healthcare System. My 
research focuses on quality and safety of medical care, and it is for 
that reason that I am here today.
            progress in patient safety, but a long way to go
    It has been 15 years since the landmark report by the Institute of 
Medicine (IOM), To Err is Human, which found that as many as 100,000 
people die every year in the United States as a result of preventable 
medical errors. IOM estimated that medical errors have a total annual 
cost of between $17 billion and $29 billion in additional care, lost 
income, and disability.\1\ As a physician, I took the oath to ``first, 
do no harm'' and yet, To Err is Human revealed to me and to doctors, 
nurses, and patients a simple truth: we do a staggering amount of harm 
every day. So here we are, 15 years after To Err is Human and it is 
critical to ask a simple question: how much progress have we made?
    First, I want to start off with some good news. We have 
dramatically increased our awareness of patient safety issues and 
changed how we think about medical errors. In the past, medical errors 
were thought to be the result of individuals behaving badly. We blamed 
the doctor who ordered the wrong treatment, the pharmacist who 
dispensed the wrong dose, or the nurse who gave the medication to the 
wrong patient. This idea that adverse events were due to bad people led 
to a ``deny and defend'' culture among healthcare professionals and 
prevented progress on patient safety.
    Today, we know better. We know that medical errors are largely the 
result of bad systems of care delivery, not individual providers. When 
a physician orders the wrong medication because two drugs might sound 
alike or when a patient develops a central line infection because a 
rushed surgeon didn't use proper sterile technique, we now understand 
that we need to focus on the system that produced the errors. Yes, we 
still hold individuals accountable, but we also know that humans make 
mistakes. It is part of the human condition. Asking for a healthcare 
system where doctors and nurses and other healthcare professionals are 
free of error is not only unrealistic but also naive. And it is a set 
up for failure.
    This change in thinking--that providing safe care is fundamentally 
a systems problem--is a very important step forward and is increasingly 
accepted by the medical community. And this, Mr. Chairman, is progress. 
But it is, of course, not enough. Now that we know that unsafe care is 
largely a systems problem--that is, we have systems that allow errors 
to occur and fail to safeguard patients, the next question is: What are 
we doing about it? And, most importantly, has this newfound knowledge 
made care safer? Here, the news is not so good.
    Four years ago, the New England Journal of Medicine published a 
terrific study from North Carolina hospitals that found that between 
2002 and 2007, there had been little or no progress in reducing harm 
from unsafe medical care.\2\ A recent study led by Dr. John James found 
that between 200,000 and 400,000 Americans die each year from unsafe 
medical care, which makes it the third leading killer in the United 
States, behind only heart disease and cancer.\3\ Finally, in an eye-
opening November 2011 report on adverse events in hospitals, the Office 
of the Inspector General (OIG) in the Department of Health and Human 
Services found that 13.5 percent of Medicare patients suffered an 
injury in the hospital that prolonged their stay or caused permanent 
harm or death. An additional 13.5 percent of Medicare patients suffered 
temporary harm such as an allergic reaction or hypoglycemia. Together, 
the data suggest that more than one in four hospitalized Medicare 
beneficiaries suffers some sort of injury during their inpatient stay, 
much higher than previous rates. The OIG report also found that unsafe 
care contributes to 180,000 deaths of Medicare beneficiaries each year, 
and that Medicare pays at least $4.4 billion to treat these 
injuries.\4\
    Despite all the focus on patient safety, it seems we have not made 
much progress at all.
    The news is not all bad, of course--and there are areas where we 
have made meaningful gains. The area of safety that has seen the 
biggest improvement is healthcare-associated infections. And there are 
two important actors to mention in this space. The first is Dr. Peter 
Pronovost of Johns Hopkins University. He developed a simple, five-item 
checklist, which was implemented in over 100 intensive care units in 
Michigan to reduce rates of central line infections. Each of these 
infections can cost up to $50,000 to treat and requires an average of 7 
additional days in the hospital.\5\ Though the problem of central line 
infection is complex and expensive, Pronovost's checklist intervention 
was not. By implementing this checklist, participating Michigan 
hospitals reduced their rate of central line infections to essentially 
zero in 3 months.\6\ Rather than targeting individual providers, the 
checklist improved the system of care and brought tremendous 
improvement in outcomes. The checklist program has now been implemented 
in over 1,100 intensive care units across the country, and is saving 
lives and resources every day.\7\
    The other key player is the Centers for Disease Control and 
Prevention (CDC). In 2005, the CDC established the National Healthcare 
Safety Network (NHSN). NHSN is a voluntary, online system that tracks 
healthcare-associated infections nationwide. The CDC has established 
standard metrics for assessing and reporting healthcare-associated 
infections (HAIs) and allows providers to collect their own data and 
report it anonymously and directly to the CDC. NHSN allows providers, 
healthcare executives, and policymakers to track infection rates and 
ensure that necessary preventive procedures are being followed.\8\ 
Thanks to NHSN, hospital leaders are able to compare their facilities 
with others to see where improvement is needed.
    NHSN is based on the idea that good metrics, provided in a timely 
fashion, can have a profound impact on provider performance. Between 
2008 and 2012, rates of central line infections decreased by 44 
percent, and rates of infection linked to the 10 most common surgical 
procedures fell by 20 percent.\9\ In short, we have made significant 
progress in reducing the number of infections caused by the healthcare 
system.
    Despite important strides on healthcare-associated infections, 
recent data on medical errors indicate that we have a long way to go. 
And, in many ways, the problems that have been described above do not 
capture the totality of the problem.
    While much attention in patient safety has been paid to acute 
hospitals, we have generally paid far less attention to what happens 
when patients are discharged. In a different report, the OIG at HHS 
found that 22 percent of Medicare beneficiaries in skilled nursing 
facilities (SNF) suffered a medical injury that prolonged their stay or 
caused permanent harm or death. An additional 11 percent suffered 
temporary medical injury. All told, OIG estimates that adverse events 
cost Medicare roughly $2.8 billion per year, and about half of these 
events are preventable. The OIG report is particularly alarming given 
that about 20 percent of hospitalized Medicare patients go to a SNF 
after discharge.\10\ We need a renewed call to improve patient safety 
as a national priority.
                       international comparisons
    It is instructive to compare our progress on patient safety to 
other developed countries. The Organization for Economic Co-operation 
and Development (OECD) Health Care Indicators group measures and 
compares quality of health services in 20 developed countries. They 
look at several types of hospital errors including postoperative 
sepsis, postoperative blood clots (venous thromboembolism), and failure 
to remove foreign bodies during a medical procedure. For all of these 
metrics, the United States does about average, maybe slightly better 
(see figures 1-3). While average is OK, given that we spend more on 
healthcare than any other country, we should be a lot better.\11\ Our 
high spending is not buying us particularly safe care. In addition, it 
is hard to say how accurate these rankings are given the variation in 
how countries report, code and calculate patient safety. Nonetheless, 
the OECD scores show that hospital errors are not only a domestic 
issue, but also an international one. With targeted policy efforts, we 
can become a world leader in patient safety.
                         policy recommendations
    Given the tremendous amount of work that still needs to be done, 
the Federal Government has a responsibility to take meaningful, 
effective action on patient safety. In most industries, the payer of a 
service ultimately holds providers of that service accountable for 
safety and quality. In that way, the Federal Government, as the 
Nation's largest payer of healthcare, needs to lead on improving 
patient safety. I believe there are important, bipartisan actions that 
Congress can and should take to improve the safety of care that 
Americans receive. In 2011, Dr. David Classen and I published an 
opinion piece in the New England Journal of Medicine that outlined 
several concrete steps that the government could take to improve 
patient safety.\12\
    The strategy for improvement has to focus on three main areas: 
metrics, accountability, and incentives. Getting the metrics right may 
be the most important.
    The fundamental problem is that most healthcare organizations don't 
track the safety of their care.
    First, we should ask the CDC to expand its patient safety efforts 
in the model of NHSN. The 2012 NHSN budget was just $19 million and 
with small additional funding, NHSN could expand its monitoring efforts 
beyond infections to other types of adverse events.\13\ The resources 
required would be small change compared to the potential savings to the 
Medicare program. If there is one area of healthcare where simple 
interventions can save money, it is in patient safety. For example, 
blood clots cost the U.S. healthcare system somewhere between $5 
billion and $10 billion per year.\14\ If expanded efforts by the CDC 
reduced the incidence of blood clots by just 1 percent, our country 
would save between $50 million and $100 million annually, not to 
mention the benefit of increased health for our citizens. This is an 
opportunity for us to make a small investment that is likely to have 
huge returns and pay for itself over time.
    Next, there are currently a variety of safety metrics being used by 
different Federal agencies. It would be beneficial for Medicare to take 
the lead, as it did in the creation of the Hospital Quality Alliance, 
to bring together stakeholders and use a standardized set of safety 
metrics.
    In addition, I believe that health information technology has a 
critical role to play in improving patient safety. Health IT is a key 
tool for improving care. All the evidence to date suggests that the 
passage of the Health Information Technology for Economic and Clinical 
Health (HITECH) in 2009 has led to significant increases in the 
percentage of hospitals with electronic health record (EHR) systems. In 
the first year that HITECH incentives were available, we found that the 
proportion of hospitals with basic EHR systems nearly doubled.\15\ In 
order to receive HITECH incentives, providers must demonstrate that 
they are ``meaningfully using'' their Health IT systems. The criteria 
for Meaningful Use is determined by the Centers for Medicare and 
Medicaid Services (CMS), with input from the Office of the National 
Coordinator.\16\ Despite recent progress in adoption of Health IT, most 
healthcare organizations are not using this tool to maximize its impact 
on patient safety.
    One key role that EHRs can play is helping track adverse events. 
Most hospitals, even those with EHR systems, do not know their own 
rates of adverse events. They don't know how often they harm patients. 
However, there are now tools available that automatically track these 
events and these tools are generally quite good. Yet, most EHR vendors 
have not put these tools into their EHR systems. I believe that if we 
made automated patient safety monitoring a key part of certification 
for meaningful use, it would have a dramatic effect on the EHR vendor 
industry. The EHR products now being built would scan clinical data and 
provide real-time surveillance information to doctors, nurses, 
pharmacists and other healthcare providers about potentially bad events 
that might be happening to patients. It would allow hospitals to 
intervene quickly, and track their own progress over time. As we have 
seen with the NHSN program, good metrics provided to stakeholders in a 
timely fashion can drive systems improvement.
    But metrics and reporting alone will not be enough. We also need to 
make safe care part of the business of providing healthcare. And this 
requires incentives. In the current system, hospitals with high rates 
of medical injuries receive nearly the same compensation from Medicare 
as hospitals that cause fewer injuries. There is little to no incentive 
for hospitals to spearhead patient safety efforts. My own research 
suggests that engaging hospital leadership--from boards of directors to 
CEOs--may be an important target of policy efforts to improve quality 
and safety. In 2010, I led a study of leadership at 1,000 U.S. 
hospitals and found that only a minority of board chairs had received 
training in quality, focused on quality, or believed that quality was 
even an important priority.\17\ As the largest hospital payer in the 
country, Medicare can do a lot.
    One idea that has been suggested is that hospital Boards should 
receive training in patient safety, and that can be a condition of 
participation in the Medicare program. Beyond training requirements, 
CMS must implement robust incentives for hospitals to avoid medical 
errors.
    Some would argue that these incentives already exist under 
Medicare's Value-based purchasing program (VBP). VBP ties a hospital's 
payment to its performance on a variety of quality metrics, from 
avoiding blood clots to correct antibiotic selection for pneumonia 
patients.\18\ This system was designed to move Medicare away from the 
fee-for-service system, which rewards high volume of care rather than 
high quality care. I believe that this is a good start, but it is not 
nearly enough. VBP payments account for only 1 to 2 percent of total 
Medicare hospital payments and the incentives are diffusely spread out 
across many metrics. Congress has also authorized 1 percent payment 
cuts for the hospitals in the top quartile of HACs--Hospital Acquired 
Conditions. This is also a step in the right direction. However, much 
of the HAC measure is built on metrics that rely on billing 
information, and likely measure patient severity and coding variations 
as they do patient safety. Medicare should put both bigger incentives 
on the table and use high quality metrics that truly capture unsafe 
care. One idea would be for Medicare to simply not pay for 
hospitalizations where patients suffer a preventable adverse event that 
inflicts real harm.
                               conclusion
    In conclusion, I believe we are at a crossroad. Fifteen years after 
IOM's To Err is Human, we have made some progress, but we have so much 
further to go. Hundreds of people are dying every day in U.S. hospitals 
because of unsafe care. We are not alone--this is truly a global 
problem. However, with smarter metrics, greater transparency, more 
accountability and the right set of incentives, we can make big 
progress. With the right leadership, we can lead the world in patient 
safety--and the biggest beneficiaries of such an effort would be the 
American people.




                              Works Cited
    1. Kohn LT, Corrigan JM, and Donaldson MS, eds. To Err is Human: 
Building a Safer Health System. Washington, DC: Committee on Quality of 
Health Care in America, Institute of Medicine; 2000.
    2. Landrigan CP, Parry GJ, Bones CB, Hackbarth AD, Goldmann DA, 
Sharek PJ. Temporal trends in rates of patient harm resulting from 
medical care. N Engl J Med. 2010;363(22):2124-34.
    3. James JT. A new, evidence-based estimate of patient harms 
associated with hospital care. J Patient Saf. 2013;9(3):122-8.
    4. Adverse Events in Hospitals: National Incidence Among Medicare 
Beneficiaries. Department of Health and Human Services: Office of 
Inspector General. November 2010.
    5. Warren DK, Quadir WW, Hollenbeak CS, Elward AM, Cox MJ, Fraser 
VJ. Attributable cost of catheter-associated bloodstream infections 
among intensive care patients in a nonteaching hospital. Crit Care Med. 
2006;34(8):2084-9.
    6. Pronovost P, Needham D, Berenholtz S, et al. An intervention to 
decrease catheter-related bloodstream infections in the ICU. N Engl J 
Med. 2006;355(26):2725-32.
    7. Kuehn BM. Hospitals slash central line infections with program 
that empowers nurses. JAMA. 2012;308(16):1617-8.
    8. About NHSN. Centers for Disease Control and Prevention. http://
www.cdc.gov/nhsn/about.html. Published November 6, 2013. Accessed July 
10, 2014.
    9. Adverse Events in Hospitals: National Incidence Among Medicare 
Beneficiaries. Department of Health and Human Services: Office of 
Inspector General. November 2010.
    10. Adverse Events in Skilled Nursing Facilities. Department of 
Health and Human Services: Office of Inspector General. February 2014.
    11. Health at a Glance 2013: OECD Indicators. OECD. November 21, 
2013.
    12. Jha AK, Classen DC. Getting moving on patient safety--
harnessing electronic data for safer care. N Engl J Med. 
2011;365(19):1756-8.
    13. Budget Request Summary--Fiscal Year 2014. Centers for Disease 
Control and Prevention.
    14. Grosse SD. Incidence-based cost estimates require population-
based incidence data. A critique of Mahan, et al. Thromb Haemost. 
2012;107(1):192-3.
    15. Desroches CM, Charles D, Furukawa MF, Joshi MS, Kralovec P, 
Mostashari F, Worzala C, Jha AK: Adoption Of Electronic Health Records 
Grows Rapidly, But Fewer Than Half Of US Hospitals Had At Least A Basic 
System In 2012. Health Aff (Millwood) 2012, 32(8):1478-85.
    16. 2014 Definition Stage 1 of Meaningful Use. Centers for Medicare 
and Medicaid Services. http://www.cms.gov/Regulations-and-Guidance/
Legislation/EHR
IncentivePrograms/Meaningful_Use.html. Published July 9, 2014. Accessed 
July 11, 2014.
    17. Jha A, Epstein A. Hospital governance and the quality of care. 
Health Aff (Millwood). 2010;29(1):182-7.
    18. Hospital Value-Based Purchasing. Centers for Medicare and 
Medicaid Services. http://www.cms.gov/Medicare/Quality-Initiatives-
Patient-Assessment-Instruments/hospital-value-based-purchasing/
index.html. Published May 8, 2014. Accessed July 10, 2014.

    Senator Sanders. Thank you very much.
    Senator Warren, you are going to introduce Dr. Gandhi?
    Senator Warren. I am. This time I'll introduce Dr. Gandhi. 
Dr. Tejal Gandhi is an Associate Professor of Medicine at 
Harvard Medical School, and she is the President of the 
National Patient Safety Foundation. She received her 
undergraduate degree from Cornell University and her medical 
degree and her master's of public health degrees from Harvard 
University.
    Before serving on the National Patient Safety Foundation, 
Dr. Gandhi was the Chief Quality and Safety Officer at Partners 
Healthcare, and she served as executive director of Quality and 
Safety at Brigham and Women's Hospital. Dr. Gandhi's research 
has focused on patient safety and on how using information 
technology can help reduce errors in healthcare.
    In 2009, she received the John M. Eisenberg Patient Safety 
Award in recognition of her research on the epidemiology and 
prevention of medical errors. So, again, we have someone who 
has done extraordinary research and put it into practice.
    Thank you for being here this morning, Dr. Gandhi.
    Senator Sanders. And not only that, but from Massachusetts 
as well.
    Senator Warren. Well, that goes without saying.
    Senator Sanders. Dr. Gandhi.

   STATEMENT OF TEJAL K. GANDHI, M.D., MPH, CPPS, PRESIDENT, 
  NATIONAL PATIENT SAFETY FOUNDATION; ASSOCIATE PROFESSOR OF 
          MEDICINE, HARVARD MEDICAL SCHOOL, BOSTON, MA

    Dr. Gandhi. Thank you, Senator Warren, and thank you, 
Chairman Sanders, for the invitation to speak today on a really 
critical topic, the topic of patient safety. I would like to 
talk to you today about ambulatory patient safety and the 
priorities and challenges that we currently face.
    The focus of patient safety efforts over the past 15 years, 
as you've heard a bit about, has been on improving patient 
safety in the hospital setting. However, it is important to 
remember that most healthcare is given outside of hospitals in 
diverse ambulatory settings such as primary care and specialist 
practices, nursing homes, rehabilitation centers, dialysis 
centers, ambulatory surgical centers, and that just names a 
few.
    The safety issues in each of these settings differ, and 
little is known about what those distinct safety issues are. We 
need better data in all of these settings to understand the 
risks and opportunities for improvement.
    The ambulatory setting that we do know the most about in 
terms of safety issues is primary care. I will touch on three 
areas, in particular, medication safety, missed and delayed 
diagnosis, and transitions of care. Studies have shown that 
medication errors are common in primary care and that adverse 
drug events or injuries due to drugs occur in up to 25 percent 
of patients within 30 days of being prescribed a drug.
    In addition, a key medication safety issue in ambulatory 
that's not an issue in hospitals is the issue of non-adherence. 
One out of four prescriptions never gets filled by patients, 
and these are prescriptions for important conditions such as 
hypertension or diabetes. Better strategies are needed to both 
reduce medication errors, but also to improve adherence.
    Missed and delayed diagnosis is a key issue as well. In the 
malpractice world, this is the most common type of outpatient 
malpractice claim, usually missed and delayed diagnosis of 
cancer in primary care. Missed and delayed diagnosis is 
complex. Some of the most common breakdowns that occur include 
failing to order an appropriate test as well as failure to 
followup on test results.
    We cannot just tell clinicians to try harder and think 
better. We need better systems to minimize cognitive errors, to 
minimize failing to think to order a test, such as computerized 
algorithms also known as decision support. Better systems are 
needed to manage test results to ensure that every test that 
gets ordered is completed, the provider receives the result, 
acts on it, and notifies the patient.
    Last, transitions of care. Transitions occur all the time 
in healthcare. For example, patients move from hospitals to 
home, from nursing homes to emergency departments, from 
rehabilitation centers to home or to visiting nursing. We know 
transitions are high-risk times when key pieces of information 
can be lost.
    For example, one study found that after hospital discharge, 
within 3 to 5 days, one-third of patients were taking their 
medications differently than had been prescribed in the 
hospital. And another study showed that 40 percent of patients 
are discharged with test results that are pending, that have 
not come back yet, and these results are often not seen by 
their subsequent primary care provider.
    Efforts have been underway across the country to improve 
transitions, such as having post-discharge followup phone calls 
to patients and better electronic systems to ensure complete 
information transfer. But there's much work that still needs to 
be done for all these varied transitions.
    A major theme throughout ambulatory safety is patient 
engagement, partnering with patients to achieve safer care. 
Clinicians need to be better engaged with patients to ensure 
that patients understand and agree with their care plan. For 
example, ensure patients understand why the medication or test 
is being ordered and why it's important and understand what the 
plan is after leaving the hospital. This needs to be a true 
partnership in order to really ensure that the goals of the 
patient are being met.
    To summarize, there are numerous ambulatory settings, all 
with unique safety issues that need more focused attention. We 
need to first develop a more robust ambulatory infrastructure 
with mechanisms for error reporting, culture change, and 
process redesign across all of the settings that I've 
mentioned.
    Second, we need to identify better measures, metrics of 
ambulatory safety, and conduct more research to understand what 
the safety risks are in these settings and how they can be 
improved. You heard a bit about metrics and the metrics that do 
exist. There are very few, if any, that exist for the 
ambulatory setting.
    And, last, we need to continue to redesign care from a 
systems and human factors approach and ensure that we are 
engaging patients in this process so that we can deliver the 
safest care. Thank you.
    [The prepared statement of Dr. Gandhi follows:]
         Prepared Statement of Tejal K. Gandhi, M.D., MPH, CPPS
    Thank you Chairman Sanders and members of the subcommittee for the 
invitation to speak today on a critical topic that I have spent my 
career working to address--patient safety. My name is Tejal Gandhi and 
I am a board-certified internist and president of the National Patient 
Safety Foundation, a non-profit that has been a leading voice in 
patient safety since 1997. I am also associate professor of Medicine at 
Harvard Medical School and was formerly the Chief Quality and Safety 
Officer at Partners Healthcare, a large health system based in Boston.
    I would like to talk to you today about ambulatory patient safety 
and the priorities and challenges that we currently face. Much of the 
effort of the patient safety movement over the past 15 years, since the 
Institute of Medicine report To Err is Human (http://www.nap.edu/
catalog.php?record_id=9728), has focused on improving patient safety in 
the hospital setting. However, it is important to remember that most 
care is given outside of hospitals, and there are numerous safety 
issues that exist in other health settings that are quite different 
from those we face in hospitals (http://www.nejm.org/doi/full/10.1056/
NEJMp1003294).
    The setting that we know the most about, in terms of ambulatory 
safety issues, is primary care. I will touch on three areas in 
particular--medication safety, missed and delayed diagnoses, and 
transitions of care. Studies have shown that medication errors are 
common in primary care, and that adverse drug events, or injuries due 
to drugs, occur in up to 25 percent of patients within 30 days of being 
prescribed a drug (http://www.ncbi.nlm.nih.gov/pubmed/12700376). In 
addition, a key medication safety issue in ambulatory care, that is not 
an issue in hospitals, is non-adherence. Patients do not fill one out 
of four prescriptions--and these include prescriptions for important, 
highly prevalent chronic conditions such as high blood pressure and 
diabetes (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2842539/). Better 
strategies are needed to reduce medication errors and improve adherence 
to medications. Of note, studies indicate that electronic prescribing 
systems show promise in the ability to significantly reduce errors, and 
much attention has been focused on expanding implementation of these 
systems.
    Missed and delayed diagnosis is a key issue as well--this is the 
most common type of outpatient malpractice claim (usually missed and 
delayed diagnosis of cancer in primary care). Missed and delayed 
diagnosis is complex--in one study, a single malpractice case had on 
average three steps in the diagnostic process that broke down and led 
to the missed diagnosis (http://www.ncbi.nlm.nih.gov/pubmed/17015866). 
Some of the most common breakdowns include failing to order an 
appropriate test, as well as failure to followup on test results. The 
answer is not simply to tell clinicians to try harder or think better. 
Better systems are needed to help minimize cognitive errors--failing to 
think to order a test--such as computerized algorithms (also known as 
decision support). Better systems are also needed to manage test 
results--ensuring that every test that gets ordered is completed and 
the provider receives the result, acts on it, notifies the patient, and 
engages them in their plan of care. This is called closing the loop, 
and electronic health records show promise in helping to do this, but 
there is much work still to be done to design these systems optimally.
    Last, we know that patients are vulnerable during transitions in 
care. These transitions occur all the time in health care--hospital to 
home, nursing home to emergency department, rehabilitation center to 
visiting nurse. Transitions are high-risk times, when key pieces of 
information (such as medication changes, pending test results, 
additional workups that need to happen) can be lost. For example, one 
study found that after hospital discharge, within 3 to 5 days, one-
third of patients were taking their medications differently than how 
they were prescribed at discharge (http://www.ncbi.nlm.nih.gov/pubmed/
16534045). Another study showed that 40 percent of patients are 
discharged with test results that are pending (the final result has not 
come back) and these results are often not seen by the patients' 
primary care providers (http://www.ncbi.nlm.nih.gov/pubmed/16027454). 
Efforts are underway across the country to improve transitions, 
particularly with the focus on reducing re-admissions, such as having 
post-discharge followup phone calls with patients and better electronic 
discharge systems to ensure complete documentation and transfer of 
information. But there is much work that still needs to be done to 
address all of these varied transitions.
    A major theme throughout ambulatory safety is patient engagement--
partnering with patients to achieve safer care (see NPSF Lucian Leape 
Institute whitepaper at http://www.npsf.org/wp-content/uploads/2014/03/
Safety_Is_Personal.pdf). Clinicians need to be better engaged with 
patients to ensure that patients understand and agree with their care 
plan--understand why the medication or test that is ordered is 
important for their care and understand what the plan is after leaving 
the hospital. This needs to be a partnership in order to really ensure 
that the goals of the patient are being met, and clinicians need to be 
trained to be better partners with patients.
    It is also important to realize that the ambulatory setting is 
incredibly diverse. There are primary care practices, specialist 
practices, nursing homes, rehabilitation facilities, dialysis centers, 
ambulatory surgical centers, the list goes on and on. The safety issues 
in each of these settings differ, and not very much is known about what 
those distinct safety issues are, though some recent studies have been 
eye opening, such as a recent report from the Office of the Inspector 
General on adverse events in skilled nursing facilities, which found 
that approximately 16 percent of Medicare beneficiaries in nursing 
homes experienced preventable harm (http://oig.hhs.gov/oei/reports/oei-
06-11-00370.pdf). We need better data in all of these settings to fully 
understand the risks and opportunities for improvement. Most of these 
settings do not have the type of quality and safety infrastructure that 
exists in hospitals, nor do they have robust mechanisms to identify 
errors or measure errors and adverse events. Many of these settings do 
not have dedicated quality and safety personnel with expertise to 
create a culture of safety (where staff feel comfortable talking about 
errors) or expertise to redesign processes of care to try to prevent 
errors.
    A final point is that health information technology (HIT) is 
becoming ubiquitous in inpatient and ambulatory settings. We need to 
design better HIT systems to maximize patient safety benefits while 
minimizing new risks that can be introduced from these technologies, as 
outlined by reports from the Institute of Medicine (http://www.iom.edu/
Reports/2011/Health-IT-and-Patient-Safety-Building-Safer-Systems-for-
Better-Care.aspx) and the Office of the National Coordinator (http://
www.healthit.gov/sites/default/files/safety_plan_master.pdf).
    To summarize, there are numerous ambulatory settings, all with 
unique safety issues that need more focused attention, especially 
because most health care is delivered in these settings. Three key 
recommendations are as follows:

     We need to develop a more robust ambulatory 
infrastructure, with mechanisms for error reporting, culture change, 
and safety expertise across all of these settings.
     We need to identify better measures of ambulatory safety 
and to conduct more research to understand what the issues are and how 
they can be improved.
     For the safety issues we do know about, we must redesign 
processes of care and further engage patients and families to ensure 
that we are delivering the safest care.

    Senator Sanders. Dr. Gandhi, thank you very much.
    Our next panelist is Dr. Peter Pronovost. He is a 
practicing anesthesiologist and critical care physician and 
director of the Armstrong Institute for Patient Safety and 
Quality at Johns Hopkins. He also serves as Johns Hopkins 
Medicine's senior vice president for Patient Safety and 
Quality.
    Dr. Pronovost has developed a scientifically proven 
checklist method for reducing the deadly infections associated 
with central line catheters, and he serves in an advisory 
capacity to the World Health Organization's World Alliance for 
Patient Safety. In 2008, he won a MacArthur Fellowship Genius 
Grant award for his work on patient safety.
    Now you make us all very nervous here.
    Dr. Pronovost. Tell my daughter that.
    [Laughter.]
    Senator Sanders. Dr. Pronovost received his M.D. and Ph.D. 
from Johns Hopkins University.
    Dr. Pronovost, thanks so much for being with us.

 STATEMENT OF PETER PRONOVOST, M.D., Ph.D., FCCM, SENIOR VICE 
 PRESIDENT FOR PATIENT SAFETY AND QUALITY AND DIRECTOR OF THE 
   ARMSTRONG INSTITUTE FOR PATIENT SAFETY AND QUALITY, JOHNS 
                HOPKINS MEDICINE, BALTIMORE, MD

    Dr. Pronovost. Mr. Chairman and Senator Whitehouse and 
Senator Warren, thank you, and you should all take comfort to 
know that your States are actively using the checklist and have 
dramatically reduced their infections. Thank you for hosting 
this important hearing and for inviting me to testify. And, 
importantly, thank you for the great work you do to keep this 
country strong.
    Our family just returned from vacation in Yellowstone, the 
world's first national park created by an inspired act of 
Congress in 1872. I believe today with this hearing, Senators, 
we have an opportunity to do that good great thing to also keep 
this country great.
    You heard the numbers of deaths, and it's important to 
recognize that medicine does perform miracles every day. 
There's hard-working, well-intentioned doctors and nurses who 
work hard every day. But what underlies these numbers of 
deaths, I think, are two important questions for you to answer.
    No. 1 is: Why is it that 15 years after ``To Err is 
Human,'' we still have to guess how many people die? Why is it 
that the public doesn't have a routine way of monitoring these 
numbers of harm? Outside of healthcare acquired infections, we 
do not have an accurate monitoring system to routinely look at, 
or let the public look at, how often harm happens, and we 
should.
    Also, I ask you: Why is it that when a death happens, one 
at a time, silently, it warrants less attention than when 
deaths happen in groups of five or tens or thousands? You see, 
what these numbers say is that every day, a 747, two of them, 
are crashing. Every 2 months, 9/11 is occurring. And we would 
not tolerate that degree of preventable harm in any other form, 
because the suffering of people who lose to death one at a time 
is just as real as those who lose to it in groups of tens or 
thousands.
    Our collective action in patient safety pales in comparison 
to the magnitude of the problem today. Medicine today invests 
heavily in information technology, yet the promised 
improvements in patient safety and productivity have frankly 
not been realized. Productivity in healthcare, indeed, has been 
negative since 1990.
    But we have a success story to guide us. Luckily, I have 
been blessed to be part of that. These central line infections 
used to kill as many people as breast or prostate cancer each 
year. That's the scope of it--30,000.
    Now, with collective effort from the CDC on how to measure 
CLABSI, with work from NIH to understand the science of how to 
improve it, with funding from AHRQ to pull groups together and 
work to reduce it, these infections are down 70 percent since 
``To Err is Human'' was reported. AMCs have reduced their 
infection rates from 6 to 1.3 per 1,000 catheter days, non-
teaching hospitals from 4.1 to 1.1, saving lives, saving money, 
producing more productive Americans.
    So why did it work, what did we learn, and what policies 
should we implement? Well, it worked, I think, because we had 
clear goals and valid measures. It worked because we had good 
science to guide us about what to do. It worked because we 
engaged clinicians through professionalism. And it worked 
because we transparently reported infections and had 
accountability.
    Yet on a deeper level, when we partnered with our 
anthropologists and sociologists to find out why, what we found 
was that it worked because clinicians told a different story. 
You see, prior to this, we all said, myself included, that 
these infections are inevitable. But with this work, we said, 
``No, they're preventable, and I can do something about it.''
    Stories are powerful forces for change, whether it's JFK 
saying, ``I want to put a man on the moon,'' Martin Luther King 
saying, ``I have a dream,'' Ronald Reagan saying, ``Tear down 
this wall.'' Change the story, and we change everything. So 
what are the stories that are holding us back, or where do we 
need stories? I think we need to say, first, that harm is 
preventable and not tolerable, that patient safety is a science 
and science must guide it, and safe systems must be designed to 
deliver safe care not based on the heroism of our clinicians.
    So what might we do for policy things? First, as Ashish 
said, charge the CDC with developing monitoring and 
transparently reporting the incident rates of the top causes of 
harm. They do it for HAI. They know how to do it for others.
    Second, create standards for the reporting of healthcare 
quality and cost measures similar to what you did in 1934 when 
you created the Securities and Exchange Act so that we now 
know--we can look at financial statements and make sure they're 
accurate. Right now, we have no guarantee that the measures 
that we're reporting are accurate.
    Indeed, Johns Hopkins Hospital was both congratulated and 
criticized for its performance on the exact same measure for 
the exact same time period for bloodstream infections. And when 
we looked, the one we're paid on, using administrative data, 
got it right 13 percent of the time. So what do we do? We will 
hire an army of nurses to code better, not to improve care.
    And, frankly, that is not what these incentives should be 
driving our hospitals to do. It is disrespectful of our loved 
ones to not have accurate data, and billing data just isn't up 
to the task for this, or at least we ought to be transparent 
about how accurate it is and not saying it's good enough or 
it's not good enough.
    Third, we need to support AHRQ to advance the science of 
patient safety; to make sure we have a workforce who has the 
training, like Tejal and Ashish, to have the skills to do this; 
and to make sure we implement programs.
    Finally, we need to invest in systems engineering and 
learning labs to improve productivity and safety. We rely too 
much on heroism. Our nurses answer a false alarm every 90 
seconds. We spend two FTEs of nursing on every unit of every 
hospital, $8 billion, manually double checking pain medicines 
because the devices don't talk to each other, and it's 
completely inaccurate.
    We had success with the checklist, but bloodstream 
infections are one harm. Patients with chronic diseases, 
patients in hospitals are at risk for a dozen harms. Every harm 
has a checklist. Every checklist might have 5 or 10 items. 
Every item may need to happen three or four times a day. You 
add it up, and you have clinicians expected to do 100 to 200 
things every day, and no information system lists them.
    What we have now, Senators, would be the equivalent of 
Boeing building a plane with many subcontractors, as they do, 
and the maker of the landing gear saying to Boeing, ``You know, 
I don't want to send a signal to the cockpit to tell you if the 
landing gear is up or down. You're going to have to guess,'' 
and Boeing says, ``No problem. We will still buy it, even 
though it will cause deaths.''
    We need to start doing another good great thing, because 
the reality is 25 patients died during this hearing.
    [The prepared statement of Dr. Pronovost follows:]
        Prepared Statement of Peter Pronovost, M.D., Ph.D., FCCM
    Mr. Chairman and committee members, thank you for hosting this 
hearing on patient safety and inviting me to testify, and for your 
dedication and determination in drafting legislation to keep this 
country great. My family recently returned from Yellowstone National 
Park and experienced firsthand that Congress can do great things that 
help America thrive and ensure it remains a global leader. In 1872, 
Congress created Yellowstone, the world's first, finest, and largest 
national park. It was and remains the envy of the world; people from 
around the world visit every year.
    Today, we have the opportunity to discuss another area where 
Congress can help save lives, improve our standard of living, and set a 
standard for the world. America medicine performs miracles every day 
and patients benefit from your investments in biomedical research. Yet 
medicine today falls far short of what is possible.
    Medicine today has preventable harm as the third leading cause of 
death. We do not know exactly how many people die needlessly, but we 
should. My colleague, David Bates, and I used published literature to 
estimate that over 220,000 preventable deaths occur from health care; 
that is over 600 deaths daily, which is far more than from mining or 
faulty automobiles yet receiving far less attention. This estimate is 
conservative and does not include more than 120,000 deaths from 
teamwork failures, 80,000 deaths from misdiagnosis, or thousands of 
deaths from sepsis.
    Medicine today squanders a third of every dollar spent on therapies 
that do not get patients well, that result from treating preventable 
complications, and that result from administrative inefficiencies and 
fraud. This is about $9,000 per U.S. household,\1\ money that could be 
better spent on preschool education and STEM, on innovation, and on 
securing a better tomorrow for all Americans.
    Medicine today invests heavily in information technology. The 
Federal Government and health care organizations have spent hundreds of 
billions of dollars on health information technology with little to 
show for it. The promised improvements in safety have not been realized 
and productivity has decreased rather than increased. A recent report 
by McKensey \2\ demonstrated that health care productivity decreased by 
0.8 percent since 1990. When you have a health care industry that 
consumes 17 percent of the GDP with negative productivity, all 
Americans suffer. There is strong consensus among economists that 
improvements in our standard of living come largely through improved 
productivity from innovation, with improvements in one sector spilling 
over into others. The University of California Berkley economist, 
Enrique Monti, estimates that every new innovative job creates seven 
additional service jobs.\3\
    We need to improve patient safety and reduce costs. Once we get 
pricing right, like in any industry, we can lower costs by reducing 
services or improving productivity. Our policy debate has focused 
almost exclusively on reducing services. While we may overuse services, 
outside of fraud and services that are clearly harmful or result from 
preventable complications, whether services are needed is a value 
judgment, with one person's overuse being another person's essential 
use. Yet no one is discussing how improving productivity can reduce 
costs, a discussion every other industry has.
    Our main policy effort to improve safety and quality is to pay for 
quality. Although economic incentives have a role in improving quality, 
their impact to date has been mixed. Incentives must be coupled with 
efforts to ensure we have valid measures of safety, research 
investments to ensure we have trained scientists to discover how to 
improve safety, and collaborative efforts to partner with provider 
organizations and professional societies to use professionalism and 
peer norms to guide improvement.
    We do have a success story that could inform our efforts. Central 
line-associated bloodstream infection (CLABSI), a type of healthcare-
acquired infection that used to kill approximately 30,000 people per 
year--about as many people that die as annually from breast or prostate 
cancer. The story begins on a snowy night in 2001 when an adorable 18-
month-old girl, Josie King, was taken off life support and died in her 
mother's arms. Josie had been burned and the clinicians saved her, but 
a bloodstream infection sacrificed her. Shortly after, her mother asked 
if health care was safer. She wanted to know what we were doing to 
prevent another unnecessary death like Josie's from happening to her 
other children and patients across America. She looked me in the eyes 
and asked, ``Peter, what are you going to do?'' That moment is etched 
in my memory.
    At the time I was one of the doctors causing those infections. I 
did not want to harm patients, no clinician does. Yet we just told 
ourselves that complications were inevitable; it was the cost of caring 
for sick patients. Back then, infection rates at Johns Hopkins were 
very high.
    We could not give Sorrel an answer, so we created an intervention 
to our efforts to provide a positive answer. We did three things. We 
used the Centers for Disease Control and Prevention (CDC) guideline and 
made a five-item checklist. We created a program called the 
Comprehensive Unit-based Safety Program to improve teamwork among 
doctors and nurses to ensure the checklist was always used and 
caregivers questioned each other when it was not. And, we reviewed and 
reported infection rates using the valid CDC definition. Infection 
rates were reduced from over 11 per 1,000 catheter days to zero.\4\
    We then applied and received a grant from the Agency for Healthcare 
Research and Quality (AHRQ) for $500,000 per year for 2 years to 
implement the intervention throughout Michigan. Bloodstream infection 
rates plummeted nearly 70 percent across the State,\5\ mortality among 
Medicare patients admitted to a Michigan ICU was 10 percent less than 
similar patients in surrounding States,\6\ we estimated the program 
prevented over 1,500 deaths per year, and saved the average hospital 
over $1 million and saved employers 150,000 to 200,000 million.\7\ With 
continued support from AHRQ and in partnership with the American 
Hospital Association, we spread this program State-by-State across the 
United States.\8\ As a result of these efforts and the combined efforts 
of many others, especially the CDC, these deadly infections have been 
reduced by 60 percent since 2000, the year To Err is Human was first 
published by the Institute of Medicine.\9\
    So why did it work? We had clear goals and valid measures, using 
CDC definitions. We had a supporting infrastructure to collect 
infection rates, summarize evidence-based interventions, and encourage 
local innovation in how to implement the evidence. Every hospital had 
their own version of the checklist and everyone thought theirs was the 
best, and it was for them. We engaged clinicians and connected them 
through clinical communities, supporting peer-to-peer learning and 
social norms to drive improvement.\10\ Finally, we transparently 
reported infections and created accountability systems, both through 
hospital governing boards and through economic incentives.
    Yet CLABSI is one type of harm, and outpatients and hospitalized 
patients are at risk of a dozen others. So we reflected on the stories 
that were holding us back. Stories are powerful forces for change. They 
can pin us to current preferences or they propel us to new pinnacles. 
The stories we tell influence how we act in the world and what we 
achieve. Stories coupled with action can move mountains. Stories like 
John F. Kennedy's, ``we will put a man on the moon,'' Martin Luther 
King's, ``I have a dream,'' and Ronald Reagan's, ``tear down that 
wall.''
    So what new stories and actions are needed? We need to declare 
right now that preventable harm is unacceptable and work to prevent all 
types of harm, including harm from care that patient's feel is 
disrespectful care, not just one harm. We need to start viewing the 
delivery of health care as a science. We need to stop relying on the 
heroism of our clinicians to ensure safety and start relying on well-
designed systems, just as every other high-risk industry has done.
    Given the number of preventable deaths, the limited ability to 
routinely measure these deaths, and the small investment in applied 
research to reduce these deaths, policy action is needed. Outlined 
below are some policy recommendations.
    Charge the Centers for Disease Control with developing, monitoring, 
and transparently reporting the incidence rates of the top causes of 
preventable harm. The CDC has a model for accomplishing this through 
its National Nosocomial Infection Surveillance (NNIS) program. In this 
program, the CDC coordinates efforts among professional societies to 
develop valid and reliable measures and widely disseminates these 
measure definitions. Hospitals have trained infection prevention staff 
who understand epidemiology and have mechanisms to collect infection 
data. The CDC has mechanisms to collect these data from provider 
organizations and the Centers for Medicare and Medicaid Services (CMS) 
transparently reports some infection rates.
    This approach can be expanded to other common causes of harm. The 
CDC can convene a similar process as they did for healthcare-acquired 
infections. Infection prevention staff could also undertake outcome or 
harm prevention, and the CDC can expand its data infrastructure to 
collect and report other types of harm.
    Invest more in career development awards for patient safety 
improvement. To reduce harm, science must guide the way but there are 
too few people trained in the science of safety to lead this effort. To 
improve safety requires an understanding of epidemiology or health 
services research to measure harm and make inferences about whether 
harm was reduced; social sciences to design and implement interventions 
to reduce harm and make inferences regarding how and why harm was 
reduced; and engineering and informatics to efficiently collect the 
desired data and design interventions. There are limited resources to 
support the transdisciplinary research teams need to make improvements 
in patient safety. AHRQ can be supported to fund both individual career 
development awards (new investigator and mid-career) and program 
projects to support the convening of all the disciplines required into 
a cohesive program.
    Support AHRQ to coordinate collaborative implementation science 
efforts to reduce harm. Central line-associated bloodstream infection 
is one of the few examples of the national reduction in a preventable 
harm. There should be many more. Nonetheless, these efforts should be 
robustly designed and evaluated using valid measures. If we are to tell 
Sorrel King and the American people if care is safer, we need valid 
measures and well-done research. AHRQ could coordinate efforts to 
reduce other harm types using the newly developed CDC definitions. In 
areas where health care lacks clinical evidence for therapies to reduce 
harm or evidence for how to implement evidence to reduce harm, the NIH 
and AHRQ should support research to eliminate that gap.
    Create standards for the reporting of health care quality and cost 
measures by creating the equivalent of the Securities and Exchange 
Commission and Federal Accounting Standards Board for health care. 
There are no standards for publically reporting performance measures or 
using them in pay for performance programs. There should be standards. 
For example, The Johns Hopkins Hospital was criticized and 
congratulated for its performance on CLABSI by two separate State 
agencies for the same time period: congratulated when measured using 
the CDC definitions, and criticized when using billing data that CMS 
uses to measure complications and withhold payment when one occurs. 
When we examined the billing data, it agreed with the more accurate CDC 
data 13 percent of the time. Johns Hopkins now has 4 percent of its 
revenue at risk in pay for quality programs. Yet with 13 percent 
accuracy, this is not a quality of care issue, it is a coding issue. 
Given the money at risk, we will have to hire an army of nurses to 
improve our coding. Nurses who we all agree would be better utilized 
providing care and preventing complications.
    There are over 1,500 procedures and thousands of diagnoses; 
everyone one should have performance measures. Despite broad bipartisan 
support to pay for value, policymakers did not create a mechanism to 
produce the many measures of quality (the numerator in the value 
equation with cost as the denominator) that patients deserve, 
clinicians want, and America needs. The reporting of costs is just as 
fragmented.
    In 1934, Congress once again did the good great thing that made 
America prosper and served as the model for the world--they passed the 
Securities and Exchange Act. Before this act, financial statements from 
businesses were not standardized, limiting the ability to evaluate the 
value of business, making markets less efficient and the country less 
well-off. This changed in 1934. Though some may debate the effect of 
the SEC as a regulator, its effect as a truth teller and a transparency 
agency is largely agreed upon. The SEC delegates authority to the 
Federal Accounting Standards Board (FASB). The SEC has public sector 
rule setting, private sector transparency and auditing, and private 
sector re-analyses, working from a common book of transparent truth, 
combining data with commentary to make the reports meaningful to 
multiple audiences.
    This process is similar to how the CDC develops measures and how we 
reduced CLABSI. The CDC partners with professional societies to make 
measures, they create mechanisms to collect the data, although they 
lack an auditing function, and our team used the CDC data to produce 
specialized reports of infection rates for the States and hospitals 
participating on our program.
    The public would be well-served if Congress repeated what it did in 
1934. By creating a process to produce valid measures of quality and 
cost, hospitals could focus efforts on improving care rather than 
coding, patients and payers could make purchasing decisions on 
actionable data rather than anecdote, and health care markets would 
compete on truth and transparency.
    Invest in systems engineering learning labs to improve productivity 
and safety in health care and ensure patient data belongs to the 
patient not the health information technology (HIT) companies. Johns 
Hopkins just built a beautiful new hospital. The outside is artwork and 
the inside is more dangerous than a hospital that was built 30 years 
ago. We bought the best intensive care unit (ICU), operating room (OR) 
and emergency room (ER) settings possible. Yet the best is backed with 
scores of pieces of equipment that do not communicate. As a result, our 
nurses answer a false alarm every 90 seconds, we spend two FTEs of 
nursing time in every unit of every hospital, $8 billion across the 
United States annually, having two nurses manually double check pain 
medication changes. This is a heroic process that is error ridden, when 
there is an electronic order in the medical record and in the 
medication infusion pump, yet these two devices do not talk. If they 
did we could automatically double check, improving safety and 
productivity, as every other industry has done with technology.
    CLABSI is one type of harm from over a dozen harms. Every type of 
harm has a checklist, every checklist has 5 to 10 items, and every item 
may need to happen three or more times per day. Add it up and patients 
need between 100 and 200 things done every day to keep them safe and 
well. None of the electronic medical record vendors, despite spending 
billions, displays this information. With a grant from the Gordon and 
Betty Moore Foundation, our team has produced an application to display 
compliance with checklists for seven types of harms.
    Moreover, the usability of most HIT is poor. For example, to obtain 
the ``meaningful use incentives,'' Johns Hopkins implemented a 
technology approved by ONC. Shortly after it was turned on, clinicians 
raised concerns that it made care less safe. After thousands of hours 
of work, we essentially turned all the supposed ``safety'' functions 
for the tool off and had the doctors type the patient's medications 
into the tool, allowing us to receive the financial incentives for 
meaningful use, hurting clinician productivity, failing to improve 
safety.
    Patients, providers and all Americans would be well-served by 
investing in a learning laboratory in which academic health systems 
collaborate with a systems integrator to build an integrated ICU, OR, 
ED or clinic. This would stimulate innovation and reduce costs like it 
has in aviation and submarines. What we have now equates to Boeing 
building a plane with many subcontractors and the manufacturer of the 
landing gear telling Boeing they would not have the capability to send 
a signal to the cockpit that the landing gear was up or down. Imagine 
Boeing saying,

          ``No problem, if you do not want to send a signal that is 
        fine; planes will crash, people will die, we will waste tons of 
        money, but the signal data is yours and if you do not want to 
        send it, OK.''

    We learned the power of systems integration from our work with the 
Applied Physics Lab at Johns Hopkins. They conduct integration work for 
the Department of Defense for space flight, and submarines. Their 
engineers estimate that we can improve health care productivity by 40 
percent, let alone improve safety by designing an integrated care 
system. Given the thousands of hospitals being built around the globe, 
we still cannot buy an integrated hospital. If the United States 
produced one, safety would improve, productivity would improve, and the 
standard of living of the American people would improve.
    Congress, you are aligned in wanting the best health care for our 
citizens, in reducing health care costs, and in improving the standard 
of living for all Americans. Once again do that great thing:

     Invest in patient safety.
     Ensure we can measure safety and develop other measures.
     Invest in training researchers to bring Engineering to 
Medicine.
     Invest in the science of health care delivery, including 
supporting learning labs to make the Boeing or Lockheed Martin of 
health care.

    You see, Sorrel King is not specifically asking Peter, What are you 
going to do to make sure care is safer, she is asking everyone of you. 
She deserves an answer.

                               References

    1. Fineberg HV. Shattuck lecture. A successful and sustainable 
health system--how to get there from here. N Engl J Med. 2012;366:1020-
27.
    2. Buescher B, Viguerie P. How U.S. healthcare companies can thrive 
amid disruption. McKinsey & Company, June 2014.
    3. Moretti E. The New Geography of Jobs. Houghton Mifflin Harcourt 
Publishing Co., New York, 2012.
    4. Pronovost P, et al. Implementing and 
validatingcomprehensive unit-based safety program. J Pat 
Safety 2005;1:33-40.
    5. Pronovost PJ, ET al. An intervention to decrease catheter-
related bloodstream infections in the ICU. NEJM 2006;355:2725-32.
    6. Lipitz-Snyderman A, ET al. Impact of a statewide intensive care 
unit quality improvement initiative on hospital mortality and length of 
stay: retrospective comparative analysis. BMJ 2011;342:d219.
    7. Waters HR, ET al. The business care for quality: economic 
analysis of the Michigan Keystone Patient Safety Program in ICUs. Am J 
Med Qual 2011;26:333-39.
    8. Eliminating CLABSI: A national patient safety imperative. Final 
Report on the national On the CUSP: Stop BSI Project. AHRQ Publication 
No. 12-0087-EF.
    9. Centers for Disease Control and Prevention. Vital signs: central 
line-associated blood stream infections--United States, 2001, 2008, and 
2009. MMWR 2011;60(8):243-48.
    10. Dixon-Woods M, ET al. Explaining Michigan: developing an ex 
post theory of a quality improvement program. Milbank Quarterly 
2011;89:167-205.

    Senator Sanders. Dr. Pronovost, thank you very much.
    Dr. Joanne Disch is a Professor ad Honorem at the 
University of Minnesota School of Nursing. She has provided 
leadership to several national organizations working to improve 
patient safety. This included past terms as president of both 
the American Association of Critical Care Nurses and the 
American Academy of Nursing, as well as board chair for AARP.
    For the past 12 years, she has been a faculty leader for 
the Quality and Safety Education for Nurses Initiative, which 
has educated more than 1,500 nursing faculty in safety science. 
Dr. Disch received her B.S. in Nursing from the University of 
Wisconsin Madison, her MSN from the University of Alabama in 
Birmingham, and her Ph.D. from the University of Michigan.
    Dr. Disch, thanks very much for being with us.

   STATEMENT OF JOANNE DISCH, Ph.D., RN, FAAN, PROFESSOR AD 
      HONOREM, UNIVERSITY OF MINNESOTA SCHOOL OF NURSING, 
                        MINNEAPOLIS, MN

    Ms. Disch. Good morning. Thank you, Chairman Sanders and 
other members of the subcommittee, for hosting this very 
important hearing.
    I would like to begin my comments by providing some 
context. First, while the subcommittee is to be commended for 
tackling this challenging issue, I believe that the title 
understates the problem. We are not only dealing with 1,000 
preventable deaths a day, but 1,000 preventable deaths and 
10,000 preventable serious complications a day, which can 
result in a quality of life that might be comparable to death 
for some, such as the woman from Minnesota who underwent a 
bilateral mastectomy for cancer only to find out shortly after 
surgery that there had been a mix-up in the biopsy reports and 
she had not had cancer.
    Second, this is possibly the most bipartisan issue that 
exists today since most of us have either been patients or 
family members or will be in the future. It affects all of us.
    Third, this is one of the few issues that money alone 
cannot solve. As I often say when I lecture to nursing 
students, even Bill Gates cannot guarantee safe care for 
himself or his family.
    This morning, I will highlight some of the key factors 
influencing patient safety and make three recommendations for 
action. First, we know the factors that compromise safety. Many 
have been mentioned: the complexity of healthcare, the 
patchwork nature of our healthcare system, the perverse 
financial incentives, and the growth of technology which can be 
a blessing and a curse.
    In addition, system barriers make doing the right thing 
hard, and time pressures reinforce doing things quickly without 
fixing underlying problems. We also have strong traditions in 
healthcare that discourage people from speaking up or examining 
problems from a system viewpoint.
    Interestingly, the Joint Commission has found three factors 
to be most commonly involved in serious preventable events. No. 
1, human factors, which includes things like staffing mix, the 
levels, inadequate orientation, fatigue, distraction, 
complacency, bias. No. 2, communication errors, whether they be 
oral, written, electronic. Again, technology can help, but it 
does add burden. And then, No. 3, leadership.
    This suggests that rather than fixing individual problems, 
we must take a systems approach and adopt fundamental changes 
in our healthcare organizations. I propose three strategies 
that, when taken together with those of my colleagues, will 
make a difference.
    First, we must ensure that we have an adequate number of 
registered nurses, appropriately educated, with a voice for 
decisionmaking about staffing and patient care at the bedside. 
This may seem obvious. Registered nurses are the cornerstone of 
the American healthcare system. They form the largest element 
with 2.7 million. They are there 24/7 and are on the ground 
floor of care delivery.
    It is the nurse who sees a skin breakdown that will lead to 
a bed sore. It's the nurse who notices the older women's 
unsteady gait and puts in place strategies to prevent a fall. 
The nurse is often the last line of defense. Unfortunately, the 
Bureau of Labor Statistics anticipates a shortage of 1 million 
nurses by 2022 due to the growing demand and the need to 
replace those retiring.
    The good news is that more people are entering nursing, and 
older nurses are working longer. But these increases are 
insufficient to meet projected demands. Of great concern is 
that U.S. nursing schools turned away at least 80,000 qualified 
applicants in 2012 due to inadequate resources. More than just 
preparing more nurses, however, research shows that we need 
registered nurses with a minimum of a baccalaureate degree and 
at adequate staffing levels in hospitals, which has been shown 
to decrease patient mortality.
    However, only 50 percent of nurses have a baccalaureate or 
higher degree in this country. So we need an adequate number of 
nurses with a minimum of a baccalaureate degree and who are 
actively involved--as Dr. Pronovost mentioned at Johns 
Hopkins--in making decisions and determining safe levels of 
staffing.
    The second recommendation is that we must engage the 
patient and family as full partners in care. Some would say 
source of control and full partner. Actually, that is what the 
IOM would say. As they noted, practice still is usually 
organized around what is most convenient for the provider, the 
payer, or the healthcare organization and not the patient.
    Yet we know that better outcomes can be achieved at lower 
costs when patients partner with their care providers and 
assume responsibility for helping manage their own healthcare. 
And we know that while clinicians have the medical expertise 
and know the science, the patient and/or family knows the 
individual best and what works for him or her.
    Third, we must change the culture of healthcare to one 
committed to safety. Again, this might be obvious. Aren't all 
hospitals concerned about safety? Of course, they are. But the 
extent to which this becomes a priority and adequate resources 
are allocated varies tremendously. We must shift from a 
bureaucratic, patriarchal model based on professional autonomy 
and independence to one of interdependence and a relentless 
focus on safety.
    We also need leaders who are passionate advocates for 
preventing harm, who commit resources for process improvement, 
and actually leaders who know what they don't know and invite 
others to help solve problems.
    In conclusion, this is enormous change. It would be easier 
if we could just throw money at it. To start, though, we can 
use the principles and encourage organizations to adopt the 
principles of high reliability organizations, where everyone 
has a laser focus on safety; where there are systems in place 
to improve processes; and where everyone, including patients 
and families, is encouraged to speak up and report errors and 
unsafe conditions. There are those organizations. We should 
make sure they get visibility and are emulated.
    Thank you.
    [The prepared statement of Ms. Disch follows:]
          Prepared Statement of Joanne Disch, Ph.D., RN, FAAN
    Chairman Sanders and the Subcommittee on Primary Health and Aging 
are to be commended for examining the current crisis of preventable 
deaths (PDs) that occur each year in the United States and for 
developing the compelling title of this hearing. The estimate by James 
(2013) that possibly 400,000 PDs occur each year is more accurate than 
the previous Institute of Medicine (IOM) projection of 98,000/year 
(1999). However, I would respectfully suggest that the title of this 
hearing understates the problem--and the title of the hearing should be 
changed to ``More than 1,000 preventable deaths--and 10,000 preventable 
serious complications a day--is too many . . . '' While PDs are 
certainly to be avoided, I would note that serious preventable 
complications (SPCs) can result in a quality of life that might be 
comparable to death for some, such as the woman from Minnesota who, 
approximately 10 years ago, underwent a bilateral mastectomy for 
cancer, only to find out shortly after surgery that there had been a 
mix-up in the biopsy reports--and she had not had cancer.
    My points are three: (1) the impact of preventable events--death 
and serious preventable complications--is even more extensive than the 
gripping title of this hearing suggests (James, 2013); (2) it is 
possibly the most bi-partisan issue that exists today--since many, if 
not most, of us here have likely had the experience of being a patient 
or family member who experienced one of these events, or will in the 
future; and (3) it is one of the few issues that money alone cannot 
solve. As I have often said when lecturing on this topic: ``Even Bill 
Gates cannot guarantee safe care for himself or his family.''
    This morning, I will highlight some of the key factors influencing 
patient safety, and make three recommendations which I know, from my 46 
years as a nurse, make a difference: (1) assuring an adequate and 
appropriately educated supply of registered nurses at the bedside; (2) 
actively engaging patients and families as partners in their care; and 
(3) moving hospitals and other health care settings to embrace a safety 
culture and become high reliability organizations. My comments focus on 
the hospital setting since that is where we have the most data, 
although the principles apply to other settings.
Factors Compromising Patient Safety
    The factors that contribute to these events have been extensively 
outlined, and range from the minor to the most comprehensive. They 
include the complexity of health care, the rapid generation of new 
knowledge and interventions, the patchwork nature of our health care 
system, the incentives to do too many interventions and not enough 
assessment and prevention, and the use of technology (both too much and 
too little).
    ECRI, an ``independent, nonprofit organization that researches the 
best approaches to improving the safety, quality, and cost-
effectiveness of patient care'' has begun to compile an annual Top Ten 
list of technology-related issues that jeopardize safety. Table 1 
includes the list for 2013.

    Table 1: The Top 10 list of technology-related issues that 
compromise patient care:

    1. Alarm hazards that result in fatigue and inadequate response by 
care providers.
    2. Medication administration errors using infusion pumps.
    3. Unnecessary exposures and radiation burns from diagnostic 
radiology procedures.
    4. Patient/data mismatches in EHRs and other health IT systems.
    5. Interoperability failures with medical devices and health IT 
systems.
    6. Air embolism hazards.
    7. Inattention to the needs of pediatric patients when using 
``adult'' technologies.
    8. Inadequate reprocessing of endoscopic devices and surgical 
instruments.
    9. Caregiver distractions from smartphones and other mobile 
devices.
    10. Surgical fires.

    Some factors relate to health care providers (HCPs) themselves, 
such as fatigue, disruptive behavior (Rosenstein & O'Daniel, 2008), 
lack of adequate preparation, and either failure to keep up with 
current practice or persistence in following outdated practices (Disch, 
2012). Amalberti and colleagues (2005) identified five system barriers 
that would prevent unsafe professional behavior, among them, the (1) 
the need to abandon status and self-image in exchange for inclusion and 
respect for the contributions of all providers; and (2) the need to 
reduce provider autonomy, i.e., doing what one chooses to do over 
evidence-based practices. Makary (2012) described inadequate levels of 
transparency and outright concealment of certain results in his 
riveting book Unaccountable: What hospitals won't tell you and how 
transparency can revolutionize health care.
    With all of these factors contributing to preventable deaths and 
complications, it can be over-whelming to know where to focus first and 
with the greatest impact. The Joint Commission has created a list each 
year of the most frequently identified root causes of sentinel events 
derived from Root Cause Analyses of the serious events that must be 
reported whenever they occur. There are 28 of these events, and include 
serious medication errors, falls that result in significant harm or 
death, hospital-acquired infections, decubitus ulcers (bed sores). Over 
the years, the analyses have found that the majority of events have 
several root causes. In 2013, the most frequently identified root 
causes of 887 sentinel events are listed in Table 2:

    Table 2: Most frequently identified causes of sentinel events 
reviewed in 2013:

    Human factors (635)
    Communication (563)
    Leadership (547)
    Assessment (505)
    Information management (155)
    Physical environment (138)
    Care planning (103)
    Continuum of care (97)
    Medication use (77)
    Operative care (76)

    It is important to note that the first three factors relate to 
people:

     Human factors--staffing levels, staffing skill mix, staff 
orientation, in-service education, competency assessment, staff 
supervision, resident supervision, medical staff credentialing and 
privileging, rushing, fatigue, distraction, complacency, and bias.
     Communication--oral/written/electronic, among staff, with/
among physicians, with administration, with patient or family.
     Leadership--organizational planning and culture, community 
relations, service availability, priority setting, resource allocation, 
complaint resolution, collaboration, standardization and best 
practices, inadequate policies and procedures, non-compliance with 
policies and procedures.

    This is not to suggest that the cause of preventable deaths are the 
people involved. The challenges facing HCPs are complex; system 
barriers make doing the right thing hard; time pressures reinforce 
doing things quickly without fixing underlying problems; long standing 
traditions that demand errorless performance and discourage examination 
of systems' fallibility create a chilling environment; and the whole 
field of safety science is unknown to most HCPs who graduated more than 
10 years ago. The point here is that the changes that are needed will 
require changes in behavior and mindset--and these are the most 
difficult to achieve. It would be easier if we could just allocate more 
money. Common wisdom used to be that those of us in health care just 
needed to be vigilant to prevent mistakes. There is still a role for 
vigilance but that is woefully inadequate in today's health care 
environment. There are certainly responsibilities that we as care 
providers have, but safety science suggests that we must also fix the 
underlying system issues for sustainable change which requires 
significant change from all of us.
The Critical Role Of The Nurse In Patient Safety
    Nurses are the cornerstone of the American health care system. 
Registered nurses form the largest element (2.6 million), with more 
than half (58 percent) working in medical and surgical hospitals (BLS, 
2013). They provide care 24/7 and are on the ``ground floor'' of care 
delivery. They are the eyes and ears of patients and their families, as 
well as physicians and other HCPs who are interacting with the patient 
intermittently. The nurse's role is to assess the patient's condition 
and response to treatment; perform indicated treatments; prevent 
complications; assist the patient and family in adjusting to the 
treatment or impact of chronic illness; and create a safe environment 
within which health, healing or a peaceful death can occur. It is the 
nurse who sees a skin breakdown that will lead to a bedsore; it is the 
nurse who notices the older woman's unsteady gait and puts in place 
strategies to prevent a fall; it is the nurse who notices that the dose 
of the drug ordered is not relieving the pain and who initiates a 
conversation with the physician to get the order changed. Individuals 
who have been hospitalized, or have had a family member hospitalized, 
understand the essential role of the nurse. Actually, nursing care is 
the reason for hospitalization . . . and it is the nurse who is the 
``last line of defense'' against error.
    Who could argue with this point of view? Our current health care 
system is built on the belief that the physician is the captain of the 
ship and needs to be in charge in every setting and situation. However, 
given the complexity of health care today, that is impossible, may be 
dangerous--and is actually unnecessary. Rather, today we need 
interprofessional teams of caregivers who can each contribute their own 
expertise and perspectives. Sometimes the physician would be in charge, 
at other times the nurse or social worker or pharmacist, depending on 
the patient's needs.
    The elderly are particularly vulnerable to complications and the 
consequences can be more serious when errors occur. Older individuals 
are often less physically stable, have chronic conditions for which 
multiple drugs and treatments are ordered, can have sensory deficits, 
and memory impairment. If they are unsteady on their feet, they are 
more prone to falls; if they are not active, they are prone to bedsores 
and other complications. Inadequate levels of RN staffing in hospitals 
and nursing homes decrease the nurse's ability to prevent 
complications. It is vital that nurses--and really any HCP--be 
respected for their knowledge and skills, and be encouraged to actively 
speak up when they think that something can be improved or a problem 
prevented. But that is not common practice in every setting today.
    The Institute of Medicine (2011) has recommended that ``Nurses 
should be full partners, with physicians and other health 
professionals, in redesigning health care in the United States.'' In 
most instances, physicians are actively involved in decisionmaking. And 
the focus in improving health care has often been to assure enough 
physicians are educated. However, this crisis will not be solved by 
focusing only on an adequate supply of physicians, both in the pipeline 
and in practice. Registered nurses and other HCPs are equally essential 
and need to be actively funded and included. This issue of nurses being 
involved and engaged in individual patient and systemwide 
decisionmaking is not simply a matter of parity, i.e., that nurses 
should be included because physicians are. Rather it's a matter of 
perspective, i.e., that nurses bring a vital viewpoint to safety 
concerns that is often absent yet essential if workable solutions for 
safe care are to be put in place.
    The question that nurses often ask is ``Does this work at 2 am?'' 
We have a very pragmatic appreciation for what works round the clock, 
and on weekends. We often have solutions for seemingly intractable 
system issues, or personal situations. One recent example: A nurse and 
physician were talking with a patient with congestive heart failure who 
was needing his medications adjusted. The doctor provided detailed 
instructions and asked the patient to weigh himself daily, and to call 
back if he gained more than 3 pounds. After the physician left, the 
nurse asked the patient if he had a scale on which to weigh himself, 
recalling his housing situation and that he was homeless. To adapt the 
directions to his situation, she asked him to carefully note whether 
his shoes became tighter--and to call back if that happened. That is an 
example of a nurse personalizing care to prevent a complication and 
needless hospitalization.
    In considering what can be done to reduce preventable deaths, we 
must redirect our efforts. First, rather than continuing to work at the 
margin we must now turn toward fundamental change in our health care 
organizations; and second we have to focus on three crucial strategies 
that are often overlooked because they seem so simple and apparent--and 
yet they are essential if we are to make progress.

    1. Assure an adequate number of appropriately prepared registered 
nurses.

    For nurses to make their optimal contribution to improving the 
safety of health care, there have to be enough nurses and they have to 
be equipped with the right educational preparation. According to the 
BLS (2013), the Registered Nurse is listed among the top occupations 
for job growth through 2022, with an expected increase from 2.71 
million in 2012 to 3.24 million in 2022 (19 percent increase). The BLS 
also projects the need for 525,000 replacement nurses, so that the 
total number of job openings for nurses from both causes would be 1.05 
million by 2022. The good news is that more people are entering 
nursing--in 2013, there was a reported 2.6 percent enrollment increase 
in entry-level baccalaureate programs in nursing (AACN, 2013), yet this 
increase is insufficient to meet projected demands for nursing services 
in all settings. More than 32 million Americans are gaining access to 
healthcare services provided by registered nurses and advanced practice 
registered nurses (APRNs). Of great concern is that U.S. nursing 
schools turned away 79,659 qualified applicants from baccalaureate and 
graduate nursing programs in 2012 due to insufficient number of 
faculty, clinical sites, classroom space, clinical preceptors, and 
budget constraints (AACN, 2013). Also the most recent information 
indicates that the average age of today's nurse is 47 years (HHS, 
2010).
    There is a significant body of research, both here and abroad, that 
shows that registered nurses with a minimum of a baccalaureate degree, 
and at adequate staffing levels in hospitals, have a positive impact on 
patient safety, including mortality rates (Needleman, ET al., 2006; 
Aiken, et al., 2014). Key implications are that nursing staffing cuts 
to save money jeopardize patient safety and hiring more nurses with 
baccalaureate degrees could decrease the number of preventable deaths. 
However, the most recent data indicate that only 50 percent of nurses 
have baccalaureate or higher degrees (HRSA, 2010); and if we look at 
the percentage of nurses in baccalaureate programs as their first 
educational program, it is only 35 percent (IOM, 2011). The IOM has 
recommended that it be 80 percent by 2020. [There is currently a bill 
being proposed in Congress called the Registered Nurse Safe Staffing 
Act to assure an adequate number of nurses with baccalaureate degrees 
be hired. This would have significant impact on patient safety].
    In addition to formal education, however, nurses and all HCPs need 
to be knowledgeable and competent in the IOM's required competencies 
for achieving safe patient care: patient-centered care, teamwork and 
collaboration, informatics, safety, evidence-based practice and quality 
improvement. Many nurses, physicians and other HCPs received their 
educational preparation more than 10 years ago when health professions' 
curricula did not contain this content so that both health 
professionals' students and practicing HCPs need to be educated in 
these competencies.

    2. Engage the patient and family as partners in care.

    Another vital partner in assuring safe patient care is the patient 
and his/her family. Whereas health care has traditionally been offered 
in a well-intentioned, yet patriarchal fashion, with the physician 
knowing best, today's health care delivery requires that the patient 
and his/her family become ``the source of control and full partner'' 
(Cronenwett, et al., 2007). This is distinctly different from the way 
health care has traditionally been provided, and in most settings, is 
currently provided today. As the IOM report The Future of Nursing: 
Leading Change, Advancing Health noted:

          ``Practice still is usually organized around what is most 
        convenient for the provider, the payer, or the health care 
        organization and not the patient'' (2011, p.51).

    Patient-centeredness is actually not a new concept. Barnsteiner 
(2014) notes that Hippocrates taught the first medical students to 
``provide by listening to the patient'' and prior to the establishment 
of hospitals, individuals were routinely cared for in their homes by 
family members. However, many contemporary factors have altered this 
relationship: professional autonomy, the medical model of health care, 
the education of health professionals, technology, the pressures of 
time, the complexity of the options available, and the perverse 
incentives for financing of health care.
    Increasingly, the consumer movement (Disch, 2014) and the patient 
movement belief of ``Nothing about me without me'' are creating 
pressures for active engagement by individuals and their family members 
in health care decisions. This is a good thing: It has become 
increasingly apparent that better quality outcomes are achieved when 
patients partner with their care providers and assume responsibility 
for managing their own health (Balik, Conway, Zipperer & Watson, 2011). 
While HCPs know the science best, the patient and/or family know the 
individual best. Appendix A includes a true story of the powerful 
impact and positive change that can occur when including a patient's 
preferences in managing her medications.

    3. Institute a safety culture with High Reliability Organizations 
(HROs).

    Over the past 15 years, the quality and safety (Q/S) literature has 
included findings from hundreds of studies examining strategies for 
improving Q/S, such as rapid response teams; rounds; patient safety 
audits; checklists; and patient safety officers. However it has become 
increasingly clear that while these efforts can improve safety at the 
margin, a more systemic, upstream approach is needed--an entire culture 
dedicated to safety.
    According to the Agency for Healthcare Research and Quality (2010), 
a safety culture of an organization is:

        ``the product of individual and group values, attitudes, 
        perceptions, competencies, and patterns of behavior that 
        determine the commitment to, and the style and proficiency of, 
        an organization's health and safety management. Organizations 
        with a positive safety culture are characterized by 
        communications founded on mutual trust, by shared perceptions 
        of the importance of safety, and by confidence in the efficacy 
        of preventive measures.''

[from Organising for Safety: Third Report of the ACSNI (Advisory 
Committee on the Safety of Nuclear Installations) Study Group on Human 
Factors. Health and Safety Commission (of Great Britain). Sudbury, 
England: HSE Books, 1993]
    Sammer and colleagues (2010) conducted a comprehensive review of 
safety literature within U.S. hospitals and identified seven sub-
cultures essential for a safety culture: leadership; teamwork; 
evidence-based; communication; learning; a commitment to justice; and 
patient-centered. High-reliability organizations (HROs)--or settings 
with ``consistent performance at high levels of safety over long 
periods of time''--share several key characteristics but most 
importantly they provide ``a collective mindfulness'' which is embodied 
by everyone throughout the organization (Chassin & Loeb, 2011, 2013).
    In these organizations, everyone is clear that even small failures 
in process or systems can result in catastrophic outcomes, and that 
everyone has a role to play in identifying errors and near-misses. 
Everyone is actively encouraged to be part of the problem-finding and 
solution-generating models of shared governance and patient engagement 
are thriving. Everyone includes patients and their families. Of 
particular importance in HROs is the need for a ``greater reliance on 
[interprofessional] teams and increased complexity in terms of team 
composition, skills required, and degree of risk involved'' (Baker, Day 
& Salas, 2006) Also in HROs, the leaders are passionate advocates for 
preventing harm and alter their roles from the traditional one of 
focusing on the financial bottom line to one of being equally concerned 
about the Q/S bottom line.
    At the core of high reliability organizations are five key 
concepts, which are essential for any improvement initiative to succeed 
(AHRQ, 2008):

    Sensitivity to operations. Preserving constant awareness by leaders 
and staff of the State of the systems and processes that affect patient 
care. This awareness is key to noting risks and preventing them.
    Reluctance to simplify. Simple processes are good, but simplistic 
explanations for why things work or fail are risky. Avoiding overly 
simple explanations of failure (unqualified staff, inadequate training, 
communication failure, etc.) is essential in order to understand the 
true reasons patients are placed at risk.
    Preoccupation with failure. When near-misses occur, these are 
viewed as evidence of systems that should be improved to reduce 
potential harm to patients. Rather than viewing near-misses as proof 
that the system has effective safeguards, they are viewed as 
symptomatic of areas in need of more attention.
    Deference to expertise. If leaders and supervisors are not willing 
to listen and respond to the insights of staff who know how processes 
really work and the risks patients really face, you will not have a 
culture in which high reliability is possible.
    Resilience. Leaders and staff need to be trained and prepared to 
know how to respond when system failures do occur.

                               Conclusion

    A great deal of work has been done over the 15 years since To err 
is human was published (IOM, 1999), and progress is being made. A 
phenomenal amount of resources have been made available through AHRQ, 
the Department of Defense, Department of Veterans Affairs, and 
organizations such as the Institute for Health Improvement. Patient 
safety networks and consumer groups have been formed; surveys have been 
developed; incentive programs have been created. A lot of people are 
doing good work.
    However, to increase the rate of improvement and reduce preventable 
deaths and serious implications, we must move upstream and implement 
some of the more challenging, yet fundamental strategies for a safe 
healthcare system. We must change the systems of care and how we 
fundamentally think about and work together to reduce preventable 
deaths and serious complications.
    I have highlighted here three strategies that, from my perspective 
as a nurse for more than 45 years, yield the greatest benefit:

    1. Assuring an adequate number of appropriately educated registered 
nurses.
    2. Engaging patients and their families in the care process.
    3. Establishing a safety culture where every hospital is a High 
Reliability Organization.

    Thank you for this opportunity to comment on this vital topic.

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                                 ______
                                 
                               Appendix A

                      [HealthLeaders, April 2012]

           Patient-Centered Care Redistributes Responsibility

                          (By Betty A. Marton)

    In 2008, a 23-year-old woman with severe cystic fibrosis (CF) 
successfully carried and delivered a healthy, full-term baby girl at 
Long Island Jewish (LIJ) Medical Center, in New Hyde Park, NY. Despite 
that major achievement, the complex regimen of daily medications that 
Christina Marie McDonald needed to manage her disease created 
challenges. ``On the maternity ward, no one understood anything about 
CF,'' says Ruben Cohen, M.D., director of the adult CF program and co-
director of the asthma center for the 888-bed tertiary teaching 
hospital. ``She didn't receive her medications when she needed them.''
    ``After that experience, the patient's father wrote a letter 
asking,

          `Why does the hospital tie our hands and put these routine 
        measures in the hands of busy medical personnel when the 
        patients and their families know the illness very well and are 
        experts in their own care?' ''

explains Fatima Jaffrey, M.D., director of outcomes research at LIJ 
Medical Center. The hospital realized they needed a new way of doing 
things. LIJ Medical Center embarked on a process to explore how to 
improve the in-hospital delivery of daily medications to CF patients.
    In February 2009, Jaffrey began coaching an interdisciplinary team 
of all the frontline caregivers, including Cohen, and a respiratory 
therapist, dietician, nurse, pharmacist, CF social worker, and 
Christina's father, in how to apply the methods of improvement science 
to improving CF care. The team focused on how it could support and 
empower the patient while still meeting regulatory requirements. ``The 
goal,'' says Jaffrey, was to go from ``a system of care that wasn't 
deeply connected to patients' experiences to one that is incredibly 
connected.'' Six months after it was established, the team met its 
first two goals of reducing the length of time patients had to wait for 
the delivery of the medications for which they were admitted--to 2 
hours (from 15 or more) for the first breathing treatment and 4 hours 
(from 18) for IV antibiotics.
    The program went live in March 2010, with patients who opt to self-
administer receiving special locked boxes containing all of their 
medications. Patients keep a log of what they take and when and nurses 
review the log to determine if medications are being taken correctly. 
The nurses also work with the hospital's pharmacists to keep the box 
replenished. ``The process gives the nurses oversight so we can still 
manage the documentation,'' says Margaret Murphy, RN, senior 
administrative director of patient care services.

          ``It all seems so simple in retrospect, but at the time it 
        required a lot of coordination and education. It offers a 
        tremendous amount of efficiency while ensuring that the 
        patients who know their medications are administering them 
        correctly.''

    Having dramatically reduced the time it takes to provide the care 
CF patients need has reduced the average length of stay in the hospital 
for CF patients to 7 days from 11. The success of self-administration 
is also reflected in patient and professional satisfaction surveys: 
Satisfaction rates for both groups rose from less than 20 percent 
before the intervention to above 95 percent. ``What's remarkable is 
that this sophisticated work can only be done at ground level,'' 
explains Jaffrey.

          ``People who do the day-to-day work can get through these 
        issues with so much velocity. When we empower them to be the 
        change agents, we're leveraging the largest untapped resource 
        we have in healthcare.''

    Senator Sanders. Dr. Disch, thank you very much.
    Our next panelist is Lisa McGiffert, who is the director of 
the Safe Patient Project at Consumers Union, a policy and 
action division of Consumer Reports. Ms. McGiffert directs a 
multistate campaign to initiate infection reporting 
legislation, which has passed in 27 States and Washington, DC, 
and raise public awareness on the prevention of medical harm.
    Ms. McGiffert serves as the consumer liaison to the CDC 
Healthcare Infection Control Practices Advisory Committee and 
is a consumer representative on the National Quality Forum 
Healthcare Associated Infections Steering Committee. Prior to 
joining Consumers Union, Ms. McGiffert worked for the Texas 
Senate Committee on Health and Human Services.
    Ms. McGiffert, thanks very much for being with us.

 STATEMENT OF LISA McGIFFERT, DIRECTOR, SAFE PATIENT PROJECT, 
                  CONSUMERS UNION, AUSTIN, TX

    Ms. McGiffert. Thank you, Senator Sanders, for holding this 
hearing, and to Senators Whitehouse, Murphy, and Warren for 
being here.
    I'm not going to go over the statistics because they've 
been covered. But I do want to make the statement that the 
response from policymakers, healthcare leaders, and regulators 
does not come close to match the scope of this problem, and 
that is exactly the focus of this hearing, as I understand it.
    I want to talk about the patients, because the impacts on 
patients vary and can be anywhere from minor harm to death. 
Regardless of the scope of the impact of a medical error, most 
people's lives are affected, and they're affected beyond the 
healthcare that they need or the physical response.
    People who are harmed lose their jobs. They lose their 
homes. They lose their health insurance. Many go bankrupt, 
trying to pay the medical bills that they would not have had 
had they not been harmed by the healthcare provider they sought 
help from. These are very real consequences of the failure to 
take action to eliminate medical errors. They are our sisters 
and brothers, parents and children, and they are disabled, and 
many of them are dead because of these events.
    Patients have been betrayed by the system in which they 
place their trust, not because we expect perfection from nurses 
and doctors, but because we trust that they will use the best 
knowledge; diligent adherence to the best practices; pay 
attention to what we tell them and ask of them; understand that 
when we pay for their services, we expect it will include doing 
all they can to keep us safe from harm; and when they make a 
mistake, they will realize it, admit it, and correct it.
    For 10 years, my project at Consumers Union has conducted a 
national campaign to eliminate hospital infections and medical 
errors. A major strategy for us in reaching this goal is to 
improve public transparency. In 2003, we developed model 
legislation to create hospital acquired infection reporting and 
took it across the country, recruited people who had been 
harmed to help us pass these bills, and now 31 States and 
Washington, DC have these laws. And as most of you know, a 
Federal program requires reporting of infections.
    The creation of the CDC National Healthcare Safety Network 
was essential to making this happen. That was created right 
around the time when we were going across the country, and many 
of the States adopted that as the way that they would report 
infections. So it is true that we have this system in place 
that is a standardized system that we could use to collect 
information about more infections as well as medical errors. 
That is really essential in moving us forward.
    Public disclosure is a critical element to preventing these 
events from happening, because it informs people about 
healthcare outcomes and motivates providers to do more to 
prevent errors. Our work also includes working with people who 
have been harmed, and I'm very grateful for all that they have 
taught me. I wish they all could be here with me today. I know 
many of them are watching, and many of them sent letters to 
Congress last week urging them to create a national patient 
safety board and to step up their efforts to address this 
national crisis.
    I'd like to touch quickly on three things: transparency, 
oversight, and accountability. We have an infrastructure for 
oversight of healthcare provided by hospitals and physicians 
and others. But it doesn't work very well for consumers seeking 
reliable information or for patients trusting that oversight 
agencies will respond promptly when standards of care are not 
followed.
    Public transparency can address some of these issues. I 
want to be clear that we're talking about transparency of the 
events, not patient-related information. But our system is very 
secretive, and it needs to change. The government holds lots of 
information about harm that's being done that is not readily 
available to the public, and they could make it more easily 
available.
    The oversight system does not work for patients. We have 
this network of oversight at the State level and at the Federal 
level, and it is not responsive. Our healthcare system does 
save lives every day, and we all know that that happens, but 
it's also rife with dishonesty and stonewalling when patients 
are harmed.
    Linda Carswell, whose husband died suddenly in a Texas 
hospital, had to fight in court for years to get his heart 
back, an organ that early on could have revealed that he died 
due to medications given in the hospital. Alicia Cole, who 
barely survived infections following routine surgery, 
discovered that photos from her hospital records were not 
submitted to the medical board when they asked for information.
    Hospital boards and leaders of hospitals regularly choose 
to spend their money on things that will bring in profits 
rather than activities that will improve the safety of 
patients. We need someone on our side to look over this system, 
and that is why we're asking for an independent national 
patient safety board. We need someone to listen to patients, 
because they offer real insights to what needs to be done, and 
we need someone to make this network of systems work for us.
    I'd be happy to talk to you more about this through the 
question and answer.
    [The prepared statement of Ms. McGiffert follows:]
                  Prepared Statement of Lisa McGiffert
    Consumers Union, the policy and advocacy division of Consumer 
Reports, appreciates the opportunity to speak to the Subcommittee on 
Primary Health and Aging about an urgent health care crisis--medical 
errors and health care-acquired infections that kill as many as 440,000 
people \1\ and harm an estimated 8.5 million \2\ every year in this 
country.
---------------------------------------------------------------------------
    \1\ James JT, ``A new, evidence-based estimate of patient harms 
associated with hospital care.'' Journal of Patient Safety, 2013 
Sep;9(3):122-8. doi:10.1097/PTS.0b013e3182948a69.
    \2\ http://www.aha.org/research/reports/tw/chartbook/2014/table3-
1.pdf. According to the AHA, in 2012 approximately 34 million people 
were admitted to American hospitals; one in four is calculated as 8.5 
million patients.
---------------------------------------------------------------------------
    The impact on patients varies--from minor harm that is addressed 
quickly to permanent disability to years of recovery to death. People 
who are harmed lose their jobs, their homes, their health insurance. 
Many go bankrupt trying to pay the medical bills that they would not 
have had if they had not been harmed by a health care provider. These 
are the very real consequences of the failure to take action to address 
the problem of medical errors. They are our sisters and brothers, 
parents, and children. They have been betrayed by the system in which 
they placed their trust. Not because we expect perfection from nurses 
and doctors, but because we trust that they will use the best 
knowledge, diligent adherence to the best practices, pay attention to 
what we tell them and ask of them, understand that when we pay for 
their services we expect it will include doing all they can to keep us 
safe from harm, and when they make a mistake they will realize it, 
admit it, and correct it.
    Since 2003, Consumers Union's Safe Patient Project has conducted a 
national campaign to eliminate hospital acquired infections and medical 
errors. A major strategy for reaching this goal is to improve public 
transparency about these mostly preventable events. We developed model 
legislation and initiated debates in nearly every State on whether 
hospitals should disclose their infection rates. Thirty-one States 
passed laws based on our hospital infection model before a Federal 
program required such reporting for most U.S. hospitals. Public 
disclosure is a critical element to preventing these events from 
happening--it informs people about health care outcomes and motivates 
health care providers to do more to prevent errors.
    Our work includes organizing patients and their families who have 
been harmed by medical care and who are working to improve the health 
care system to prevent harm from happening to others--in their 
communities and nationally. Many of them sent letters to their 
congressional members last week urging them to create a National 
Patient Safety Board and to step up efforts to address this national 
crisis.
    We acknowledge that many individuals, hospitals and other health 
care institutions are working to eliminate medical errors. Their work 
and progress is often the subject of congressional hearings. But 
today's hearing, highlighting this national tragedy, is a call to 
action for a very big problem--millions of Americans are at risk for 
death and serious injury but the response by our leaders fails to match 
the scope of this epidemic.
    Consider this headline: ``House to push for answers on why GM 
failed to recall cars despite knowledge of flaws ultimately linked to 
13 deaths.'' The CDC home page this week highlighted salmonella 
infections from sprouted chia powder and pet bearded dragons and ecoli 
from raw clover sprouts--but nothing on infection outbreaks in U.S. 
hospitals. The VA faces significant actions for delays in care, but is 
anyone asking about medical errors that occur at the VA and put 
soldiers in harms way? Diabetes kills nearly 70,000 people each year 
and there is a significant emphasis in our health care system to 
eradicate this disease. But what about the third leading cause of 
death? Where are the programs reaching out to help patients who are 
suffering from medical errors? Where is the demand for accountability 
of the deaths caused by preventable hospital-acquired infections?
 Medical Errors: The Third Leading Cause of Death in the United States
    Many names are given to medical errors and some, like ``mishaps'' 
and ``misadventures'' are offensive to the patients affected. The most 
used list of medical errors was developed by the National Quality Forum 
(NQF). These are commonly referred to as ``never events'' but 
officially named ``serious reportable events.'' The never events name 
was appropriate because these are things that should never be happening 
to patients in hospitals. The list includes surgical errors (such as 
surgery on the wrong patient, the wrong body part or leaving a foreign 
object in the body), care management (such as medication errors, blood 
errors, maternal or infant deaths during normal deliveries, serious bed 
sores), product or device-related events (such as contaminated drugs, 
death due to intravascular air embolism in the use of an IV), 
environmental events (such as electrical burns, falls, electric 
shocks), and criminal and patient protection issues (such as abduction 
of a patient, sexual assault of a patient, suicide).
    In 2011, Consumer Reports polled Americans about patient safety and 
asked them the terms they would use to describe these events. Medical 
errors and medical mistakes topped the list (48 percent combined). 
``Adverse events,'' a term commonly used by professionals was barely 
recognized (4 percent). How we refer to these events is critical to 
raising public and professional awareness. Using understandable terms 
like hospital-acquired infections rather than ``nosocomial infections'' 
is a small but critical step toward creating a culture focused on 
eliminating them.
    While medical harm spans all providers--hospitals, doctors, 
dialysis centers, nursing homes and outpatient surgical centers--most 
of what we know is limited to what happens in hospitals. And what we 
know about hospitals is a very small part of the comprehensive problem.
    More than 10 years ago, the Institute of Medicine (IOM) estimated 
that annually 98,000 patients lost their lives due to medical harm.\3\ 
Even then it was contradicted by CDC data that estimated 88,000 deaths 
from infections alone.\4\ Using 2002 data, CDC updated their estimate 
to 99,000 deaths from hospital-acquired infections.\5\ And the agency's 
2014 prevalence estimate, based on a 2011 study was 722,000 infections 
in 648,000 patients and 75,000 deaths. This reflected a change in the 
incident rate from 5 percent to 4 percent of hospital patients or on 
any given day, 1 in every 25 patients will get an infection.\6\ Clearly 
this is very slow progress that cries out for more attention. CDC's 
media statement said,

    \3\ Kohn LT, Corrigan JM, Donaldson M, eds. To Err Is Human: 
Building a Safer Health System. Washington, DC: Institute of Medicine; 
1999.
    \4\ MMWR Weekly, February 25, 2000; ``Fourth Decennial 
International Conference on Nosocomial and Healthcare-Associated 
Infections;'' http://www.cdc.gov/mmwr/preview/mmwrhtml/mm4907a4.htm.
    \5\ R. Monina Klevens, DDS, MPH; Jonathan R. Edwards, MS; Chesley 
L. Richards, Jr., M.D., MPH; Teresa C. Horan, MPH; Robert P. Gaynes, 
M.D.; Daniel A. Pollock, M.D.; Denise M. Cardo, M.D.; ``Estimating 
Health Care-Associated Infections and Deaths in U.S. Hospitals, 2002,'' 
Public Health Reports / March-April 2007 / Volume 122; PP 160-66.
    \6\ Magill, Shelley S., Jonathan R. Edwards, Wendy Bamberg, Zintars 
G. Beldavs, Ghinwa Dumyati, Marion A. Kainer, Ruth Lynfield, Meghan 
Maloney, Laura McAllister-Hollod, Joelle Nadle, Susan M. Ray, Deborah 
L. Thompson, Lucy E. Wilson, Scott K. Fridkin, ``Multistate Point-
Prevalence Survey of Health Care--Associated Infections,'' New England 
Journal of Med 2014; 370:1198-208. DOI: 10.1056/NEJMoa1306801.
---------------------------------------------------------------------------
          ``Although there has been some progress, today and every day, 
        more than 200 Americans with healthcare-associated infections 
        will die during their hospital stay.''

    Further, antibiotic resistant infections are on the rise, creating 
another crisis in the treatment of infections that occur. Even if there 
were many drug developers working on new antibiotics, the scientists 
cannot keep up with the bugs. By the time a new drug is on the market, 
resistances are forming. We cannot research our way out of this 
problem. The only way out is rigorous infection prevention and 
aggressive antibiotic stewardship programs throughout the country.
    When it comes to tracking medical errors, we don't really know how 
many hospital patients are harmed because there is no national effort 
to collect this information or to make it public. But three landmark 
studies in 2010 and 2011 gave us some solid estimates of how often 
these errors and infections happen.
    The studies rocked the confidence of experts in the field who 
assumed piecemeal efforts to prevent medical harm were having an 
overall effect on improving patient safety. All of these studies looked 
at all harm--from minor to major--and included both errors and 
infections. All emphasized the need for the system to focus on a 
broader array of adverse events than the National Quality Forum list 
and serious adverse events. All used techniques that avoided the 
underreporting problems common to hospital self-reporting and 
misleading billing data.

     U.S. Health and Human Services Office of Inspector General 
(OIG) based its study on Medicare data and found that 27 percent of 
Medicare patients hospitalized in October 2008 were harmed from medical 
care. One in seven of them endured long-term and serious harm from 
hospital care (defined as events resulting in prolonged 
hospitalization, permanent disability, life-sustaining intervention, or 
death).\7\ The OIG estimated that 44 percent of the harm identified was 
preventable.
---------------------------------------------------------------------------
    \7\ Department of Health and Human Services, Office of Inspector 
General, ``Adverse Events in Hospitals: National Incidence Among 
Medicare Beneficiaries,'' Daniel R. Levinson Inspector General, 
November 2010, OEI-06-09-00090.
---------------------------------------------------------------------------
     New England Journal of Medicine (NEJM) study revealed 
similar findings--one in four hospital patients are harmed.\8\ This 
study was done in North Carolina where there had been a high level of 
engagement in efforts to improve patient safety during the 6 years 
covered by the study. Despite this work, the surprising findings showed 
little evidence that harm had decreased substantially over that 6-year 
period. At the time, no public reporting of infections or errors was 
required of North Carolina hospitals. Without information about medical 
harm, the public cannot hold these hospitals accountable for their 
errors. The NEJM study found that 63 percent of these events were 
preventable and made the important point that ``preventability'' 
changes over time as new ways to keep patients safe are tried and 
measured.
---------------------------------------------------------------------------
    \8\ Christopher P. Landrigan, M.D., M.P.H., Gareth J. Parry, Ph.D., 
Catherine B. Bones, M.S.W., Andrew D. Hackbarth, M.Phil., Donald A. 
Goldmann, M.D., and Paul J. Sharek, M.D., M.P.H., ``Temporal Trends in 
Rates of Patient Harm Resulting from Medical Care.'' The New England 
Journal of Medicine, November 25, 2010; 363;22.
---------------------------------------------------------------------------
     Health Affairs study using the Institute for Healthcare 
Improvement's global trigger tool \9\ found that one in three hospital 
patients are harmed.\10\ The study compared three methods for detecting 
adverse events in patients hospitalized in three large tertiary care 
centers--all teaching hospitals with well-established patient safety 
programs--and found the most common methods used to track patient 
safety in the United States--self reporting and pulling information 
from administrative billing documents--missed 90 percent of adverse 
events.
---------------------------------------------------------------------------
    \9\ http://www.ihi.org/resources/Pages/Tools/
IHIGlobalTriggerToolforMeasuringAEs.aspx.
    \10\ David C. Classen, Roger Resar, Frances Griffin, Frank 
Federico, Terri Frankel, Nancy Kimmel, John C. Whittington, Allan 
Frankel, Andrew Seger, and Brent C. James; `` `Global Trigger Tool' 
Shows That Adverse Events In Hospitals May Be Ten Times Greater Than 
Previously Measured,'' Health Affairs, April 2011, 30:4.

    A 2013 study, ``A New, Evidence-based Estimate of Patient Harms 
Associated with Hospital Care,'' translated existing research into a 
reliable estimate of how many patients die from medical errors each 
year. Based largely on the findings cited above, the study estimated 
that the premature deaths of more than 400,000 patients each year was 
associated with preventable medical errors.\11\ When undetected 
diagnostic errors were added to that number, the study estimated up to 
440,000 patients are harmed each year. These new estimates established 
medical harm as the third leading cause of death in the United States.
---------------------------------------------------------------------------
    \11\ James, JT, ``A new, evidence-based estimate of patient harms 
associated with hospital care.'' Journal of Patient Safety, 2013 
Sep;9(3):122-8. doi:10.1097/PTS.0b013e3182948a69.
---------------------------------------------------------------------------
          the role of public transparency in improving safety
    Consider if Consumer Reports tested 50 cars and found some 
performed well and others were unsafe, but refused to reveal which cars 
fell into each category. The public would not be served by such 
evaluation and it would seem ridiculous to go to the trouble of looking 
at this information and then hiding it. But that is how reporting on 
patient safety issues was traditionally handled. Summaries that do not 
identify the hospital or physician in charge of patients' care when 
errors occurred are not useful--the information should be publicly tied 
to where the harm occurred. In recent years, the trend has been 
changing and it has provided useful tools for improvement--
fundamentally, one cannot measure progress unless metrics are being 
documented.
    In the past 10 years, 31 States and the District of Columbia have 
mandated public reporting of certain hospital-acquired infections and 
these hospital-specific reporting laws have stimulated more activity 
around infection prevention than this Nation has seen in previous 
decades. And, now Federal payment policies have created incentives for 
reporting infections that hospitals in other States cannot resist. 
While this infection reporting is still giving us a limited snapshot, 
new measures are being added each year. Only two States--Pennsylvania 
and California--require the kind of comprehensive reporting needed to 
evaluate hospitals' overall infection safety.
    However, the reporting of other types of medical harm currently in 
place fails to create external pressure for change. In most cases 
hospital-specific information is confidential and under-reporting of 
errors is not curbed by systematic validation of the reported data. 
Currently, about half of the States require hospitals to report certain 
types of medical harm, but only 10 require reporting this information 
by hospital. At the Federal level, some medical complication 
information is revealed through the Hospital Compare Web site, but it 
is limited. Without hospital-specific information, key elements for 
stimulating change are missing: public accountability and hospitals' 
awareness of their record and that of their peers.
    Another hurdle exists in deciding which events should be reported. 
A 2010 series in the Seattle Times clearly illustrated the problems 
arising from narrowly defining ``harm'' in a way that ensures most harm 
will not be reported. One article told of a man who entered the 
hospital for a simple outpatient arthroscopic shoulder surgery and, 
according to State investigation records, sustained brain damage and 
died due to nursing errors, including a misadministration of pain 
medication. This was clearly a case of preventable medical harm but the 
harm did not fit into any definitions under Washington State's 
reporting law, so was not reported. These are the issues that the 
previously mentioned studies by the Office of Inspector General and the 
NEJM pointed to in their conclusions--we need a system that identifies 
all preventable harm, not just those that fit into a narrow definition.
    The question often asked is whether public transparency improves 
safety. While it is impossible to parse out the impact of public 
reporting mandates from the prevention activities they have stimulated 
and the programs that followed to tie payments to performance, we do 
have some evidence that transparency is making a difference.
    In a report issued last March, the Center for Disease Control and 
Prevention (CDC) documented a 44 percent decrease in central line-
associated bloodstream infections between 2008 and 2012. This is the 
one measure that almost every State with an infection disclosure law 
required to be reported. Further, CDC reported that the rates of other 
types of infections are coming down: 20 percent decrease in infections 
related to the 10 surgical procedures tracked between 2008 and 2012; 4 
percent decrease in hospital-onset MRSA between 2011 and 2012; and 2 
percent decrease in hospital-onset C. difficile infections between 2011 
and 2012.
    Many States have documented similar reductions from year to year in 
their public reports. For example, in New York, overall surgical site 
infection rates had decreased by 16 percent between 2007 and 2012, 
resulting in a cost savings estimated to be between $12.1 million and 
$35.4 million since 2007. And, bigger improvements were made in 
specific surgical procedures such as coronary artery bypass surgery, a 
23 percent-47 percent decrease since 2007.\12\ New York is probably the 
most reliable State, as it has validated the infection data each year.
---------------------------------------------------------------------------
    \12\ ``Hospital Acquired Infections, New York State, 2012,'' New 
York State Department of Health, Albany, NY, September 2013; page 4; 
https://www.health.ny.gov/statistics/facilities/hospital/
hospital_acquired_infections/2012/docs/hospital_acquired_infection.pdf.
---------------------------------------------------------------------------
    There are attitude changes that come with public transparency. 
Minnesota is one State that publishes facility-specific information 
about medical errors on a State Minnesota Department of Health Web 
site. Seventy-two percent of Minnesota facilities surveyed in 2008 felt 
that the Minnesota error reporting law made them safer than they had 
been when reporting began in 2003. One respondent said,

          ``(Our) focus was always on patient safety, however now 
        safety efforts are better understood by more of our staff and 
        we prioritize this work ahead of other work. Data is helping us 
        to create more sense of urgency for this work.''

    Evidence of individual hospital successes to reduce errors abound 
and Federal programs recently documented a 9-percent decrease in 
hospital-acquired conditions and an 8-percent decrease in re-
admissions, which are often connected to errors or infections.\13\ None 
of this documentation would be possible without public reporting 
mandates.
---------------------------------------------------------------------------
    \13\ http://innovation.cms.gov/Files/reports/patient-safety-
results.pdf.
---------------------------------------------------------------------------
                 another kind of transparency is needed
    Transparency at the patient level is absolutely critical to ending 
medical errors. When patients are harmed, they often are subjected to 
additional harm when caregivers fail to disclose or explain what 
happened. Medical records are withheld or altered or never documented 
accurately. Many families have to file lawsuits just to get information 
about how their loved ones died. This is the underbelly of medical 
errors--the cover-ups and the insults to injury. We must create a more 
just and fair system that encourages discussions without requiring 
patients' rights in exchange, that compensates patients for their 
losses and that treats them with dignity and respect.
                            recommendations
    Because of the significant scope of this problem--tens of thousands 
of service delivery points and hundreds of millions of patient contact 
points--the solutions can seem overwhelming. Many programs are in place 
today but they are fragmented and the results of their efforts are 
difficult to track. Fundamentally, as a nation just as with hospitals 
and other institutions, a comprehensive, coordinated approach is 
needed. This is why Consumers Union and many of the advocates with whom 
we work are supporting the creation of a National Patient Safety Board, 
modeled after the National Transportation Safety Board. We would 
welcome the opportunity to work with Members of Congress to develop a 
plan for creating this oversight agency.
    Some additional recommendations are briefly listed below. More 
information about them can be provided upon request.

     Support the infrastructures needed for public reporting 
and tracking of infections and errors. For example, the CDC's National 
Healthcare Safety Network (NHSN) collects information from more than 
10,000 providers. We need to sustain this system and ensure that it can 
grow in capacity into the future. This should include funding to the 
States to validate data being reported.
     Expand hospital infection reporting so that infections are 
being documented throughout the hospital and consumers have a clear 
picture of a hospital's overall infection rate.
     Mandates are needed for antibiotic stewardship. Require 
hospitals to report on antibiotic usage and resistant infections using 
CDC-NHSN's new modules for this purpose.
     Require medical error reporting. Electronic billing 
records could be used as a resource for documenting these events by 
improving their accuracy. Create a rigorous validation process that 
includes fines for hospitals that fail to accurately document patient 
stays.
     Require death certificates to indicate when infections or 
errors are the cause of death and document the presence of these events 
preceding or at the time of death.
     Hospital infection outbreaks should be disclosed to the 
public, the patients in the hospital, and patients being admitted.
     Make the National Practitioner Data Bank public so 
patients can refer to it to check on physicians that have licenses in 
multiple States.
     Continue adding measures to Medicare pay for performance 
programs and consider standardizing how incentives and penalties are 
calculated. Keep the programs growing but simplify the calculations.

    Senator Sanders. Thank you very much, Ms. McGiffert, for 
your testimony, and thank you all. I think this has been 
excellent testimony. Let me begin the questioning.
    Dr. Jha, you work for the VA occasionally, right, and I'm 
chairman of the Senate Committee on Veterans Affairs. We've 
been hearing a whole lot on the front pages of newspapers 
throughout the country about problems in the VA, and they're 
legitimate problems, and we've got to deal with those problems. 
But I think, as many of the panelists have indicated, we 
haven't heard a whole lot about this issue.
    I think, Dr. Pronovost, you indicated that we don't know 
exactly how many people died because of errors. But you used 
the analogy of two large airplanes a day going down. Is it 500 
people a day dying or 1,000 people? We don't know. But it's a 
lot of people.
    So my first question is: How come this story is not on the 
front pages of the papers every single day? If somebody dies in 
a VA hospital, it's a big story. It should be. But if 500 
people every single day die, that also is a big story. So 
that's one question.
    Well, let's start at that one. Why is this issue not 
getting the kind of attention that it deserves? Who wants to 
start that one off?
    Dr. Jha.
    Dr. Jha. Let me make two quick points. One, to that 
question, Senator, when people go to the hospital, they are 
sick, and it is very easy to confuse the fact that somebody 
might have died because of a natural consequence of their 
disease versus they died because of a complication from a 
medical error.
    The bottom line is that it has taken work like the work 
that Dr. Pronovost has done to prove to all of us that many of 
these deaths are not a natural consequence of the underlying 
disease. They are purely failures of the system to address the 
problem. That has been a wake up call for clinicians, for 
physicians, like me, for nurses to know that we can do so much 
better.
    Senator Sanders. Good. Let me just run to Dr. Pronovost.
    Dr. Pronovost. I think there's three reasons that it 
doesn't get visibility, as Dr. Jha said. The first is that 
we've labeled so much harm as inevitable--it's the result of 
being sick--that we now know is preventable. The difference in 
harm estimates between the IOM report of 1999 and today isn't 
that care got worse. It's just that all these other deaths that 
we put in the inevitable bucket we now moved into the 
preventable bucket, and there's, frankly, probably even more 
that we should move.
    Second is that the deaths occur alone, one at a time, and 
silently and don't get the media attention. If you look at it 
compared to the mining in West Virginia or the automobile--the 
number of deaths are pale--I mean, they're in the tens, not in 
the hundreds a day. But look at the media attention, because 
one death at a time doesn't garner it.
    Third, if you look at what drives research agendas or your 
work, it is disease advocacy groups, like the Alzheimer groups, 
the breast cancer groups. And there's no advocacy group with 
that power for patient safety, because there are many, many 
different diseases, and there needs to be. I mean, NIH funding 
or your work is--you have to answer to those constituents. 
They're powerful. And we lack that, and we need it.
    Senator Sanders. I apologize for cutting people off, but we 
only have 5 minutes to ask questions. Let me pick up on a point 
that Ms. McGiffert raised, and that is the issue of 
transparency. If I go into a hospital, is there public 
information--I'm getting surgery--about the level of infection 
at the hospital or other preventable deaths? I mean, do we have 
the information that would allow a consumer to make a good 
choice and say, ``whoa, whoa,'' if too many people have died or 
gotten sick in that hospital because of preventable problems?
    Ms. McGiffert. We are beginning to have information. We 
don't know if the whole hospital is safe, and we do know that 
people often are treated in different parts of the hospital. 
But when it comes to surgery, it probably depends on what State 
you're in, whether the surgery you're getting is going to be 
published. In Washington State, they publish hip and knee 
implant surgery, so you're in luck there. But you're not in 
luck in Texas. And the Federal Government doesn't require that 
yet.
    So we're getting there. But it's been very slow over the 
last 10 years, and we really are just getting a small piece of 
the problem.
    Senator Sanders. Let me just jump in, and I'll go to Dr. 
Gandhi in a second. A wife has an operation. Clearly, there is 
a problem. The husband in this case says, ``You did something 
terrible.'' Maybe there's the threat of a lawsuit. Is it not 
true that many of these settlements will not be made public, 
that we don't know how many types of settlements have been made 
because of poor practice?
    Dr. Gandhi, is that an accurate statement?
    Dr. Gandhi. That's an accurate statement. So I want to talk 
about transparency. I think you mentioned other infection rates 
available for someone going in for surgery, and I think that's 
getting more available. But there's so many other pieces of 
information that someone needs to know before they go in. And 
maybe they're not going for surgery. Maybe they're going to see 
a primary care doctor. What do they need to know? So I think 
the amount of good information available to patients is 
minimal.
    But on the transparency front, I think it's important to 
think of transparency on a couple of different levels. So, 
first, we need transparency with patients, as we were just 
talking about, with data, transparency about errors, 
transparency about why we're doing the care that we're doing.
    But then there are other levels of transparency that we 
really need to think about. One of the things that I think is a 
huge lost opportunity is transparency across organizations. To 
your point about a malpractice case, or even an error that 
didn't lead to malpractice--my hospital fixes it, figures out 
how to solve it, that does not naturally leave the four walls 
of my hospital.
    Things are getting reinvented, and things are happening 
constantly around the country. I think we need better 
mechanisms to ensure that sharing across organizations when 
these events do occur.
    Senator Sanders. We're going to have other rounds of 
questioning, but I wanted to get to Senator Warren.
    Senator Warren.
    Senator Warren. Thank you, Mr. Chairman. According to the 
CDC, about 75,000 people die annually with infections they get 
while they're in the hospital. I think it's a shocking number. 
We should be doing everything we can to drive that to zero. 
Now, we already know a lot about how to reduce these deaths. 
Some of the simplest things, like better hand washing, more 
thorough room cleaning, establishing protocols for catheters 
and ventilator tubes, have shown to reduce these infections.
    I want to brag here just a little bit. Boston Children's 
Hospital, which treats some of the sickest children in the 
world, has had terrific success at implementing steps like 
these. Boston Children's has not had a single case of 
ventilator associated pneumonia in the cardiac ICU in nearly 2 
years and not a single catheter associated urinary tract 
infection in the medical ICU for over 2 years.
    In other words, I just want to start with what we already 
know. We know how to make patients safer. Unfortunately, it's 
not happening everywhere. We need a system in place to promote 
the adoption of these practices. So my question is this: Can 
you help us understand why certain healthcare entities have not 
yet adopted straightforward, proven techniques to reduce these 
infections?
    Dr. Jha, would you like to start?
    Dr. Jha. I would be happy to, and it's a terrific question. 
Fundamentally, the question in front of us is how do we have an 
industry where you have cheap, easy interventions that save 
lives, save money, and not every single person is using it 
every day? It's like there's a disconnect here. Something 
doesn't make sense.
    It strikes me that when I look at places like Boston 
Children's, when I look at Hopkins, when I look at these 
leading organizations, what they're doing is driven by 
passionate leaders who care deeply despite all the incentives 
in the system that don't give them any rewards for doing this 
kind of stuff. That's the problem. If we have a system that 
relies on heroes and great leaders and people like Peter 
Pronovost to solve all of our problems--I'd love to clone this 
guy. But that is not a policy solution for the problem we have.
    We've done work that has looked at hospital CEOs and what 
determines CEO pay in nonprofit hospitals. These are the 
organizations that have a nonprofit status. Quality outcomes, 
patient safety--none of those things influences the pay of the 
CEO. So until we get to a point where the CEO of the hospital 
is lying awake at night worrying about patient safety, I don't 
think we're going to really, meaningfully move the needle 
beyond these few leading organizations that are going to do it 
no matter what incentives we put in place.
    Senator Warren. OK. Good. Dr. Gandhi wants to add to that.
    Dr. Gandhi. I just want to add that it's also critical for 
boards of directors to be better educated about this topic. 
Often, boards are much more focused on the financial aspects of 
how the hospital is running, especially, and I understand that 
these are hard financial times for many hospitals. But having 
boards of directors that really understand this issue and then 
can push it through the organization is also really key.
    Senator Warren. Good.
    Dr. Disch.
    Ms. Disch. I'd like to add also that there are some very 
simple procedures, and it seems like we should be able to just 
say, ``Wash your hands.'' And yet when you get down into even 
that simple of a basic, which we all know is the No. 1 
preventative action you can take, it really becomes complex. So 
you need the leaders that really will say, ``We are as 
concerned about safety as finance.''
    But you also need the resources in place. Even for 
something as simple as washing your hands, you need the right 
equipment. There's got to be sinks that are accessible. You've 
got to have the soap that's there--housekeeping making sure the 
soap dispensers are filled. If the nurse and physician comes 
with a bunch of equipment, where do they put that down? On the 
floor to wash their hands? I don't think so. So it's just such 
a ripple effect that you need equipment, you need people to 
understand what's going on.
    I was going to mention earlier about transparency. Staff 
have to understand what's going on with the metrics in their 
organization. So we can do national promoting. We can do 
information among hospitals. But staff need the feedback that--
here's our infection rate, here's what we're doing, here's 
where we're improving. So all of those go into something as 
simple as hand washing.
    Senator Warren. Dr. Pronovost, you wanted to add to this?
    Dr. Pronovost. Senator, you should have been on our 
research team with your question. We were curious to see what 
allowed a hospital to get to zero like Boston Children's versus 
not. So we borrowed a technique from the nuclear industry 
called peer-to-peer review. They developed it after Three Mile 
Island--no regulatory role, where one nuclear facility visits 
another.
    So we went into hospitals that were zero to try to 
understand. What we found was there was no magic bullet. But 
there was a clear chain of accountability and practices that 
led them to get to zero. So they were zero, and if the CEO 
said, ``Our goal is zero,'' and they look at their rates, they 
knew it.
    They were zero if they provided enabling support 
structures, so they had good infection prevention to educate 
staff. They were zero if the ICU director and nurse manager 
owned the problem. So we walked in there and said, ``What's 
your rates?'' And they knew it. They were zero if they had a 
culture where nurses could openly question doctors for not 
using the checklist, and that was well received.
    They were zero if the frontline staff got feedback about 
their infection rates, and they investigated every infection as 
a defect. We know this chain of command. We just haven't 
implemented it. But if you did one of them, you may go down a 
little bit. You wouldn't get to zero. But if you put them all 
together, you have a great program.
    Senator Warren. So I'm going to ask for the chair's 
indulgence, if we can just follow with this line.
    What would you change in Federal and State requirements, 
policies, to drive us in that direction? As I say, this is not 
the part about the cutting edge new magical things we've got to 
figure out, but the things like washing your hands that are 
going to drive down the rate of deaths, the rate of infections.
    Why don't I start with you, Ms. McGiffert, and we'll come 
back down the line.
    Ms. McGiffert. I think there's a lot of things that can be 
done to make the payment incentives more meaningful. For 
example, in the hospital-acquired conditions payment program, 
the disincentive is simply to not pay for the hospitalization 
during which the event occurred. But that person on Medicare 
has to get wound care, doctor visits, back in the hospital, 
medications, all kinds of expenses that Medicare is paying for. 
And that hospital should be held responsible for the whole 
range of things that that patient needs.
    Senator Warren. So we've got a payment response.
    Ms. McGiffert. A payment response.
    Senator Warren. Very powerful. And I'll ask you to do these 
quickly, because I am over my time.
    Dr. Disch.
    Ms. Disch. The one thing that I think about is what 
Minnesota is doing, and what they have, which many States have, 
are hospital engagement networks. They bring together the CEOs 
and senior leaders to take a look at what they are doing and 
have conversation across institutions, which creates the 
incentive of: ``How come yours is doing so much better than 
ours?'' And they talk among themselves.
    Speaking with some of the officials from the Hospital 
Association, I said to them, ``How many of the CEOs in our 
State do you think are really changing and becoming not only 
concerned about finance, but also the preventable event bottom 
line?'' And she said, ``It's really changing the dial when they 
sit down and talk and they share stories.'' But it's not just 
the CEOs. It's the senior team, just like was mentioned before. 
It's got to be medical leadership, nursing leadership, and that 
comparison and sharing of information is happening at the State 
level.
    Senator Warren. Dr. Pronovost.
    Dr. Pronovost. Senator Warren, right now, we have reduced 
these infections dramatically. But there are several hundred 
hospitals who have rates 10 times the national average, and 
there is no accountability outside of Lisa's or the public 
reporting. They're fully accredited, and we know if they did 
these things, they can get to zero.
    I would love to see us start with bloodstream infections, 
because you can't pull a hammer unless you have a good measure. 
But we have a good measure for this, and we have evidence that 
it's leadership. If you're not down low, it's a leadership 
failure. No excuses. So I think we could say we need a 
mechanism to say, ``If your hospital is high, you shouldn't be 
accredited.'' There should be some greater sanction, because we 
know.
    Senator Sanders. Let me just jump in and pick up on a 
point. You're saying you know that there are some hospitals 
that have infection rates 10 times higher than other hospitals. 
Do the American people know who those hospitals are?
    Dr. Pronovost. Senator, I know about those because of the 
work of Consumers Union, and several States require public 
reporting. And their newspapers--Chicago did it, Baltimore did 
it--would write newspaper articles listing the hospitals that 
are high. But outside of that public sanction, literally, 
there's no followup.
    I mean, you'd say, ``OK. Well, you're accredited, and you 
meet--to the Joint Commission,'' which is great. You do that. 
But people are dying. Who is responsible for saying 10 times 
too high isn't appropriate? And we know you can fix it.
    Senator Warren. So what would you do, Dr. Pronovost? What 
would be the next step? We've got Consumers Union out there 
hitting on this. But what would you do next?
    Dr. Pronovost. I think we need, either at a Federal level 
or with the Joint Commission--but CMS should say, ``If your 
rates''--and I would start with this one measure, because we 
know the measure is good, and the evidence that you can get low 
is good.
    Senator Warren. If your rates----
    Dr. Pronovost. Are above the national average, you get told 
you have a quarter--because we know the infection rates plummet 
when you do these things, literally, immediately, within 
months.
    Senator Sanders. You're talking about accreditation.
    Dr. Pronovost. Correct. You'll be sanctioned or you'll lose 
your accreditation.
    Senator Sanders. I want to get to Senator Whitehouse.
    Senator Warren. Go ahead. I apologize. I do want to be sure 
that Dr. James gets a chance to participate in this, too.
    Senator Sanders. Yes.
    Senator Warren. OK. Thank you, Mr. Chairman.
    Senator Sanders. Senator Whitehouse.
    Senator Whitehouse. Thank you very much, Chairman. The 
clear accountability that everybody, I think, agrees is a very 
important signal is hard to develop without clear data. I am 
concerned that there is kind of a tower of Babel problem, that 
a provider has to report through multiple means of reporting to 
the Federal Government; I think in every State through multiple 
means of reporting to the State government; through whatever 
reporting mechanisms the individual insurers that they do 
business with have built into their systems; through whatever 
local systems might have been set up if there's a regional or 
municipal quality initiative; and potentially through their ACO 
process and some of the quality improvement processes.
    By the time you've loaded up all that reporting, two things 
have happened. No. 1, the reporting begins to eat up the actual 
repair, and, No. 2, the noise overtakes the signal. So if a 
hospital gets a bad report, the first thing that I hear them 
say is, ``Oh, that data is not good. If you look at this, we're 
actually doing better over here.''
    So while, obviously, we want robust reporting, and while 
some of this is a moving target you need to keep up with, to 
what extent do you think we should be focusing on simplifying 
and directing attention to a few clear, agreed measures that 
can then become kind of barometers for the system behind them? 
Back to Dr. Disch's point that, fundamentally, this is a 
problem that is a system problem. You're not going to solve it 
with discipline on doctors for mistakes. You're going to solve 
it by recalibrating the culture in the system that supports 
these decisions.
    Ms. Disch. Can I just comment that I think that's an 
excellent point to start with, because I can indicate that 
there's one institution on which I sit on their quality 
committee, and they track 1,800 indicators. Now, there is no 
sense----
    Senator Whitehouse. So how do you possibly get a signal out 
of that?
    Ms. Disch. And the staff get very cynical, because they 
will say, ``Oh, flavor of the month, scud missiles coming over 
the transom''--are the words that the staff use. So getting 
some kind of alignment and order would be immensely helpful--
reconciliation.
    Senator Whitehouse. Ms. McGiffert.
    Ms. McGiffert. I think the focus needs to be on outcome 
measures. When she talks about the 1,800 measures, a lot of 
those are process measures, like checklists, like these are the 
things we need to do, and hospitals do have to track that. But 
for public reporting, we need outcome measures. Most of the 
reporting we have now are process measures that don't really 
tell us whether or not a patient actually got an infection or 
was harmed.
    Senator Whitehouse. Dr. Pronovost.
    Dr. Pronovost. I think you're spot on, Senator Whitehouse. 
We report at Johns Hopkins well over 300 measures, and most of 
the outcomes are measured using billing data, and they are 
truly near worthless. I mean, we spend a ton of money, but what 
it does--we spend money improving coding, not improving care.
    We know the top five causes of preventable death. She named 
some of them. We should, like we did for infections, develop 
measures for those and focus on those, prioritizing where 
people are dying. Outside of healthcare acquired infections, I 
do not believe we have a system for valid measures of any other 
harm.
    Senator Whitehouse. I'll change the topic a little for the 
remaining witnesses, because I'm getting a lot of head nodding. 
So I think we all agree with that so far.
    Do you believe--starting with Dr. Gandhi and going over--
that if you were to pick a couple of really core quality 
measures, try to steer some of the clutter away from them so 
that they became much more visible, much more clear, had much 
more signal coming off of them, that that would then affect the 
type of system operations and the type of culture that has been 
repeatedly talked about and would tend to propagate in other 
areas of the institution? Or do you think you really have to 
fight it infection by infection, issue by issue, against a wall 
of bad incentives?
    Dr. Gandhi. I completely agree about the metric overload, 
and I think we do need to narrow it. The one concern I have 
about narrowing to four or five is that every focus goes there 
and there's a whole lot of other stuff that is important that 
doesn't get tackled, to your point. So I think part of those 
core metrics----
    Senator Whitehouse. Might there be some value in punching 
through to real success on those and then expanding it, rather 
than just banging against everything and not making progress?
    Dr. Gandhi. Well, true, because I think then we basically 
don't make any significant progress on any of them. But what I 
was going to say is I think it's important to think about 
infrastructure and foundational things that will raise all the 
boats, basically. So we talked about incentives for CEOs. If 
you have a culture in your organization where people are afraid 
to speak up and talk about errors, you're not going to get very 
far on any of these issues. So we have measures of that, but 
there's not----
    Senator Whitehouse. If you go to the Ford plant, the 
biggest Ford plant that makes, I think, the vast majority of 
their trucks in Michigan, any person on the line can stop the 
line. And they're absolutely protected for doing that if they 
see any kind of a flaw. You're exactly right about that. It's a 
very good process.
    Dr. Gandhi. And some organizations in healthcare have 
implemented those same strategies in healthcare.
    Senator Whitehouse. We did with the ICU initiative in Rhode 
Island. It worked really well.
    Dr. Gandhi. Exactly. So how do we measure that and 
incentivize improvement on that? Just measuring it alone isn't 
enough.
    And then the third piece in terms of infrastructure that I 
think about is training. We can't have our leaders telling 
people, ``Well, just try harder next time.'' People have to 
understand safety science and safety principles and make sure 
that everybody in the organization understands how to actually 
improve things, because things are happening all over the 
place, and it has to come from the front lines to fix all of 
the things.
    Senator Whitehouse. Dr. Jha and Dr. James, real quick. I'm 
just over my time now.
    Dr. Jha. The good news is we've done this. We've had noisy 
measurement programs, and the Federal Government has taken a 
leadership role through the Hospital Quality Alliance about a 
decade ago to align this stuff, identify a few key metrics, get 
everybody on board to start measuring and using it. I think 
because this is a public health problem, the CDC is in a 
natural role to lead it.
    If we can identify the three to five big things and go 
after it, measure it systematically, and put in incentives--
because we've all talked about culture. Culture comes from 
leadership, and leadership responds to incentives. If we have 
the right incentives, we've got the right leadership, and we've 
got the right culture.
    Senator Whitehouse. Dr. James.
    Mr. James. I'd like to ask you to think about a different 
dimension than this kind of reporting. We were doing this at 
NASA as I was leaving. It's called 360-degree reviews. If you 
talk to nurses and doctors in hospitals, they know who's doing 
it right and performing well, but they're afraid to say so if 
there's something wrong with their colleague or their boss.
    That 360-degree review works really well. It's an anonymous 
review. You don't know who's reviewing you, but you get 
feedback. So for the first couple of years, you get feedback on 
what you need to fix. I got some interesting feedback at NASA 
on what I needed to fix. And doctors get that. But then after a 
couple of years, if the physician is not fixing, according to 
the feedback he's being given, then the administrators take 
some kind of action.
    But within hospitals, it is known what's going on. You just 
have to find a way to pull that information up and get it 
available to the public.
    Senator Whitehouse. Chairman, back to you. Thank you very 
much.
    Senator Sanders. Thank you. Let me just continue with some 
questioning here. I think Ms. McGiffert was talking--or maybe 
it was Dr. Gandhi--about at the end of the day, what we're 
talking about is patients. I mean, maybe we're working--instead 
of going from patient on up, we're going from the top down to 
the patient.
    In the course of this discussion, just several 
observations. Dr. Gandhi, I believe, mentioned that doctors 
prescribe medicine. That's the therapy, and one out of four 
patients can't afford to buy the drugs. What kind of insanity 
is it that we go through the whole effort of somebody 
diagnosing a disease, here's the therapy, and, oh, it's too bad 
you can't afford the drugs?
    Dr. James talked about his own tragedy in his life, where 
after the treatment his son received, somebody knew that he 
shouldn't go out and run or do heavy athletics. But they forgot 
to tell him. So there was a lack of communication.
    I know as part of the ACA hearings that we had, Medicare 
will spend a whole lot of money doing surgery on an older 
person. Then we send that person home, and, gee, we forget 
whether the person has enough food to eat in their house, 
whether their home is warm enough in the wintertime, or whether 
they have a clue about the 15 different medicines that they're 
taking.
    We spend $50,000 on surgery, but we don't spend $500 a day 
on a social worker to make sure that those things are done. 
This speaks, I think, to a dysfunctional system, in general, 
which is to a large degree, if I may say so, profit-oriented 
rather than patient-centered.
    Who wants to comment on that? Is that true or not true?
    Dr. Gandhi.
    Dr. Gandhi. I think it is true that we do not do enough to 
ensure patients are educated and partnering with us, that 
patients understand the plan, that patients have the resources 
when they go home to actually do what we ask them to do, and 
the incentives haven't been aligned to pay for that. So with 
some of the changes around accountable care organizations, for 
example, and population care as opposed to these distinct 
episodes, I think that will help to build that infrastructure.
    Senator Sanders. But in terms of cost, if we do a major 
surgery, and it's not infrequent that people end up coming back 
into the hospital in a week because they don't take the right 
medications or get the right food, that's not cost-effective.
    Dr. Gandhi. But in the current system, that hospital gets 
paid again for that re-admission.
    Senator Sanders. Right.
    Dr. Gandhi. The hospital, in the old system, didn't 
necessarily have the incentive to ensure that everything went 
great once the patient left. That's the real challenge, that 
the incentives have been completely--or, say, in a primary care 
practice, if you had a pharmacist in a primary care practice 
who could actually talk to patients on 15 drugs and explain 
things to them, it would help a ton. But how do you actually 
pay for that person? And the incentives haven't been there.
    Senator Sanders. And that is a serious problem, is it not?
    Dr. Gandhi. Yes, it is.
    Senator Sanders. Especially for elderly patients.
    Dr. Gandhi. Elderly patients on multiple medications. 
That's why you have adherence issues. It's not always cost. It 
can be side effects. It can be not understanding why they need 
to take it. And a primary care doctor in a 15-minute visit is 
going to have a really hard time spending an hour with someone 
to really explain what----
    Senator Sanders. And we pay for that lack of information 
and knowledge later on.
    Dr. Gandhi. Exactly.
    Senator Sanders. Dr. Jha, let me ask you, with your 
experience in the VA, which is a different type of system, what 
does it do better, what does it do worse?
    Dr. Jha. The VA really took a leadership role in the late 
1990s under the Clinton administration with Dr. Ken Kizer. They 
made patient safety a priority before the IOM report. They put 
together a national center for patient safety. They have done, 
I think, leading work in this area in tracking down adverse 
events, really understanding what causes them. They have been 
phenomenal in a lot of this.
    My concern is that over the last few years, there's been a 
little bit less focus on patient safety in the VA. There's been 
a distraction with a lot of other issues. The VA in some ways 
represents some of the same problems that we've heard about, 
hundreds and hundreds of metrics now, loss of focus on what 
really matters to veterans. And because of that, I think we 
have not seen the kinds of gains in the VA that we'd like to 
see, and that we can get back again, because the infrastructure 
and the commitment is there to making it a safe organization.
    Senator Sanders. Ms. McGiffert.
    Ms. McGiffert. Can I make a little comment about that? I do 
think the VA is a good example. For example, a number of years 
ago, they started screening incoming patients for MRSA, an 
antibiotic resistant bug that people might carry on their skin. 
So their MRSA infections have gone significantly down. And the 
VA put out a directive saying, ``We're going to do this all 
over the country.''
    In the private sector, we cannot do that. We cannot--the 
only way to do it is through Medicare, and Medicare is the big 
dog here. They make things happen. I would say one of the most 
important things that can happen is that Medicare keep pushing 
on public reporting, keep pushing on these incentive payments 
so that--and I do think there probably are ways that they can 
standardize and coordinate them a little bit better.
    But this needs to keep going, and I think you're going to 
hear from a lot of hospitals who say, ``Whoa, whoa, stop 
this.'' But from the consumer perspective, we want to see 
accountability for these kinds of events, and payment 
incentives are one way to do it.
    Senator Sanders. Dr. Pronovost, getting back to the issue I 
think Senator Warren raised, if you know--maybe people in 
Detroit or a given city may know it, that some hospitals have 
rates of infection 10 times higher than another hospital. And I 
think what we've heard is you give them a warning, ``Get your 
act together or else.'' Yes? What is the ``or else?''
    Dr. Pronovost. I think our regulators, whether it's through 
CMS or the Joint Commission, have well-established policies for 
how to do this. They have largely implemented those on single 
complaints. So if you get a complaint--a patient has a 
complaint, they come and investigate--a healthcare 
organization. They review--if your policies are out of line, 
they could withhold Medicare funding, for example. They have a 
great power of sanctions.
    What they haven't applied those to are for rates of these 
infections. So they'll come in, oftentimes for individual 
events, but they haven't focused on this glaring----
    Senator Sanders. If you don't get your infection rate down, 
you're going to get a cut in the amount of money----
    Dr. Pronovost. Correct. There'll be some--and, again, they 
have a policy for issuing sanctions. They haven't pulled that 
trigger for outcomes, and I think they--we need to make sure, 
Senator, that what they do it on, the measures are valid, 
which, again, outside of HAI, there's not many of them. But for 
these bloodstream infections, as all of your States have 
reduced them dramatically, the science is good, the signal is 
good, and we need accountability.
    Senator Sanders. Dr. Gandhi, and then we'll get to Senator 
Warren.
    Dr. Gandhi. I just want to again reiterate that--because 
I've seen this happen--this one measure suddenly becomes the 
focus for the entire organization, and they fix it. Check. 
Done. Right? Instead of then--but really changing the culture 
of the organization and what the organization is working on is 
so critical, because that's one issue of many. So I think these 
incentives and accountability is critical, but we need to have 
that at a higher level than maybe a single measure.
    Senator Sanders. Senator Warren.
    Senator Warren. Thank you. I want to go back to a point 
that Dr. Gandhi raised earlier, and that is that the commitment 
to patient safety can't stop when someone leaves the hospital 
or the doctor's office. Many people come home with a 
prescription or, in some cases, with several prescriptions, and 
they have to manage them on their own. But unlike something as 
basic as aspirin, almost none of these prescriptions come with 
standardized regulated consumer friendly instructions.
    This is a huge hole in our patient-safety system. It has 
real consequences. In 2010 alone, the Centers for Disease 
Control found that more than 15,000 people died from 
unintentional prescription drug overdoses. That's entirely 
preventable, in my view, and entirely unacceptable.
    Dr. Gandhi, let me just start with you on this. Can we 
assume that at least some of these overdoses have been caused 
by people who don't understand how to properly take their 
medications?
    Dr. Gandhi. I think that's a very valid assumption.
    Senator Warren. OK. Good. Then let's go to the second part. 
Would you conclude that in addition to the thousands of people 
who die from unintentional medical overdoses each year, there 
are probably many more people who are taking their medications 
improperly because they don't understand the instructions?
    Dr. Gandhi. There's very good data to say that patients are 
often not taking medications as they were originally 
prescribed. Now, there can be a lot of reasons for that, one of 
which might be they don't understand, one of which might be 
it's really expensive and they decide, ``Well, maybe if I take 
half a pill instead of one, I'll still be OK.'' I mean, there's 
lots of reasons for that.
    But I think lack of understanding of how to take the 
medicine, what it's for, what the potential side effects are--
all of those are significant issues in the ambulatory sector.
    Senator Warren. Does anybody else want to weigh in on this?
    Ms. McGiffert.
    Ms. McGiffert. Well, Consumer Reports has spoken before 
Congress recently, within the last 6 months, I think, on the 
need to improve labeling and information to patients. It's a 
critical issue, and I think it's something that Congress can do 
something about.
    Senator Warren. Good.
    Dr. James.
    Mr. James. I knew two parents who lost young adult children 
to overdose of medication. What happens is often these are 
opioids and they're very addictive, and a lot of doctors don't 
understand the power of the addiction for these patients. So 
they get a prescription, or if they don't get what they want, 
they can go to another pain mill and get these. The system 
needs to be fixed so that that cannot happen so these young 
adults don't die.
    Senator Warren. Dr. Disch.
    Ms. Disch. This is another good example of an issue that 
really does require patients and family conversations about the 
drugs, not just prescribing and saying, ``Here's what we're 
going to put you on.'' There may be information that the 
patient or family has that this isn't a good drug, or the 
patient has taken it before.
    There is a story where a patient was ordered to change his 
diuretic and to weigh himself and come back in a couple of days 
if he gained more than 3 pounds--great education, but the 
patient was homeless and didn't have a scale. So the discussion 
about, is this going to work for you; what are the goals; and 
really personalizing even something that seems as 
straightforward as a medication prescription really requires 
talking with the person and not just prescribing for.
    Senator Warren. Dr. Jha.
    Dr. Jha. We've seen this happening, I think, in lots of 
other areas where we now have--we've changed the way we're 
labeling food. I mean, you can put lots of data out there, but 
if it's confusing, it's worse than not having any information 
at all. So, obviously, we've seen progress in this.
    There's been a lot of very good work to start pointing to 
what kind of information you need to show patients, and how you 
can present it in a way that people can understand. This is not 
rocket science. People have done the work on this, and this is 
a place where I would think the FDA--and, again, this is a 
little beyond my area of expertise of who does the regulating 
around this. But it seems to me that this is something that we 
have a clear role on to make the information much more consumer 
friendly so normal people can understand it.
    Senator Warren. Good.
    Dr. Gandhi.
    Dr. Gandhi. I want to reiterate what Dr. Disch said. I 
agree that a label alone will not solve this problem. It's a 
part of the problem, but it's really having those good 
conversations with patients about medications. But the other 
piece, too, is giving providers the tools to have those good 
conversations.
    So these patient friendly tools--electronic medical 
records, for example--could really help to provide a nice 
calendar to a patient--here's what you take and why and what 
days and so on. So I think there's tools that we need to give 
to providers to help these conversations really go well.
    Senator Warren. Good. I very much appreciate the point on 
this. But I want to summarize it this way, by saying it's clear 
that there are dangers associated with improper medications. 
It's also clear that we have consumer friendly labels for over-
the-counter drugs--Tylenol, cough syrup--and that we do not yet 
have those on prescription drugs.
    What I'm hearing the panel say is that we won't solve 
everything by getting better labels. But if we had more 
consumer friendly labels on prescription drugs--this is one of 
those things kind of like washing hands. It's at least a low-
cost, simple, direct way to make an improvement in patient 
safety that could save lives and certainly save people who have 
suffered.
    I just want to say on this one that the Food and Drug 
Administration has been working on getting consumer friendly 
labels for more than 30 years, and we still don't have them. So 
this is an area where I think we should continue to push and 
particularly continue to push the Food and Drug Administration. 
They have the authority to do this. We need to have patient 
friendly labels on prescription drugs.
    Thank you, Mr. Chairman.
    Senator Sanders. Thank you, Senator Warren.
    Senator Whitehouse.
    Senator Whitehouse. Thank you, Chairman. While Senator 
Warren is here, and Senator Murphy was here also, I want to 
thank both of them. We are working together, along with a few 
other Senators, on a piece of legislation to address the 
problem of hospital acquired infections. We are looking at 
trying to improve the meaningfulness--if that's a word--of the 
data collection and the distribution of that data, its 
transparency. We're looking at trying to reinforce the State-
based hospital acquired infection reduction efforts, because so 
much of this has come out of local initiatives. We are looking 
at improving antibiotic stewardship.
    We are also looking at trying to improve the data across 
handoffs. That's the question that I want to ask all of you 
now. We have, I think, a fairly good sense, as Dr. Pronovost 
pointed out, of the four or five elements that combine 
together, to solve a lot of the hospital acquired infection 
problems. They fight uphill against incentives that often cost 
the hospital money, cost them money to implement the program, 
and they lose the revenues that they actually got for treating 
the hospital-acquired infection they caused. So it's kind of a 
double hit to them.
    In that environment, where there is actual control, and 
you've got a CEO of the hospital and the hospital system, even 
then we see these problems. So when you're dealing with the 
handoff for a patient who, say, is going from a hospital 
setting to a nursing home, and very likely back to the hospital 
and back to the nursing home more than once, should we be 
optimistic about our ability to tackle that problem while we're 
still having so much trouble with the first problem? And what 
kind of reporting do you think would be most helpful?
    Let me ask first Dr. Gandhi, because this is your 
expertise. What should we be doing about expanding this beyond 
an intra-corporate setting within one organization to try to 
reach to the handoffs between organizations?
    Dr. Gandhi. First, I think there need to be standards about 
how these handoffs should happen, because, honestly, if you've 
seen one hospital do a handoff, you've seen one hospital do a 
handoff. So what are the key critical pieces of information 
that need to get communicated? What timeframe do they need to 
be communicated in?
    There are still hospitals out there that say a discharge 
summary can be done within 30 days of discharge. Patients go in 
to see their primary care doctor tomorrow, and we're saying 
it's OK that there can be 30 days for a hospital discharge to 
get done. So timeliness and content of those communications is 
really key. Electronic medical records can help with this, and 
there's work going on there.
    But then there's also a really critical human component, 
and the term we've been using lately is warm handoff. So if a 
patient is sick enough to go from a hospital to a rehab--
they're not going home. They're going to another facility--
often, I would say, the norm is that nobody from the hospital 
is actually talking to someone in that receiving facility.
    The patient gets on a stretcher with the chart and goes off 
with no communication verbally, and we've seen that when you do 
that verbal communication, some really important information 
gets conveyed. So standardizing that entire process, content, 
timeliness, and when you need that person-to-person dialog is 
really fundamental.
    We're just starting on this. But I don't think we can wait 
to say, ``Hospitals, fix yourselves,'' before we worry about 
this, because this care across the continuum can't just be put 
aside until a later point.
    Senator Whitehouse. And assuming, as you've said, that 
there are process measures that could be checklisted for that 
handoff, where do you think in the oversight universe the 
responsibility for overseeing that checklist should reside? Is 
that an AHRQ issue? Is that a CDC issue? Is that a CMS issue?
    Dr. Gandhi. We could create measures. I don't know if it's 
Medicare or who it would be. But just as an example, I was at 
Partners Healthcare as a chief quality and safety officer. We 
created a measure. We said these 10 things need to be in a 
discharge summary, and if you get 9 out of 10, you get a 0. We 
could measure it, and we could improve it, because we could 
measure it.
    I think your point that there needs to be a measure that 
can be tracked--I think Medicare could certainly be part of 
this. These are sometimes not easy to abstract from records, 
but we could figure out how to do it. So I think that somebody 
like Medicare would make sense.
    Senator Whitehouse. Dr. Jha and then Dr. Disch.
    Dr. Jha. One important problem here is if you look at the 
HITECH Act, which you know well, Senator--and we are providing 
incentives for doctors and hospitals to put in electronic 
health records and by all means it's going pretty well.
    Senator Whitehouse. Don't get me started on this one.
    Dr. Jha. I know this is a topic near and dear to your 
heart, Senator. But just for everybody else, let me----
    Senator Whitehouse. We left out nursing homes and 
behavioral health providers when we did that, so they're not 
part of the meaningful use program, which is really brilliant 
for people who are----
    Senator Sanders. See, he told you not to get started on 
that.
    Dr. Jha. My apologies, Senator, for egging him on on this, 
because I know this is an issue near and dear to your heart. 
But it is exactly the problem we're talking about, because the 
sickest, the most complicated, the most expensive patients 
leave the hospital and go to nursing homes, go to rehab 
facilities. Those places do not have electronic health records. 
We've tracked their data, and they're lagging way behind. So 
you can have a great electronic health record with an 
electronic summary, and you have to print it out and fax it, 
and that is no way to do business in 2014.
    Senator Whitehouse. Understood.
    Dr. Disch.
    Ms. Disch. I think we have to do a little both/and thinking 
here, because it's actually seductive to think--and we've 
talked about a couple of specific issues, labeling, infections, 
handoff, and really do a deep dive on those. But we also have 
to step back and say if we are trying to change preventable 
death, maybe like the aviation industry did, we have to start 
thinking about things like high reliability organizations, 
where the whole organization is aligned. We have people who do 
not tolerate deception, or they're preoccupied in a good sense 
with failure. We've got leaders that really are committed.
    We've got to do a both/and. We've got to work on some of 
these initial issues. But I worry that we will focus on let's 
fix this problem of the moment, let's fix that problem, and the 
aviation industry had to really restructure how they did 
business. So that has to still be on our radar screen.
    Senator Whitehouse. Thank you.
    Dr. James.
    Mr. James. Very quickly, this goes back to what Dr. Jha 
said a little bit. There needs to be a national standard for 
medical records that everybody dances to. Right now, there's a 
number of different systems, and they don't communicate well. 
I've heard that from doctors. I'm not a doctor, obviously. But 
that needs to be fixed at the Federal level, in my opinion.
    Senator Whitehouse. Thank you, Chairman. This is far and 
away the most important hearing happening today in Washington, 
DC, because of the importance of this issue and your attention 
to it, and this incredible panel that you brought together has 
really been terrific.
    Senator Sanders. Thank you, Senator Whitehouse.
    I want to concur with what Senator Whitehouse just said. We 
don't know the exact number, but we are talking probably about 
hundreds of thousands of people a year dying from preventable 
problems in hospitals and God knows how many outside of 
hospitals. What we do know is that this issue has not gotten 
the attention that it deserves, and I hope that today is the 
beginning of an effort to focus more light on it.
    I want to thank all of you and echo again what Senator 
Whitehouse said. This has been a terrific hearing. I have 
learned a lot. I hope people who have viewed it on CSPAN have 
learned a lot. You've given us ideas, not only in terms of what 
the problems are, but where we have got to go and the role the 
Federal Government has to play in terms of the CDC, the FDA, 
Medicare, Medicaid. So we have a lot to work with.
    I again want to thank you for all the work that you have 
done and for your powerful presentations today. Thank you very 
much, and this hearing is adjourned.
    I did want to add that Senator Boxer wanted to put in some 
work on patient safety issues into the record, and with 
unanimous consent, we'll do that.
    [The information referred to can be found in additional 
material.]
    Senator Sanders. Thank you all very much.
    [Additional material follows.]

                          ADDITIONAL MATERIAL

  Medical Errors--A Report by the Staff of U.S. Senator Barbara Boxer
                          i. executive summary
    Medical errors are a quiet and largely unseen tragedy. Every year 
between 210,000 and 440,000 Americans die as a result of medical errors 
and other preventable harm at hospitals, according to researchers. 
These numbers are equivalent to a jumbo jet crashing every day with no 
survivors. Based on these figures, medical errors could be considered 
the third-leading cause of death in America, behind heart disease (more 
than 590,000 a year) and cancer (more than 570,000 a year).\1\
    After meeting with a family who lost a child to medical errors, 
Senator Boxer asked her staff last year to compile a list of the most 
common and devastating medical errors. What the staff found out was 
that there was not a single list--there were many lists.
    So last spring, Senator Boxer wrote to Federal officials urging 
them to put together a single, unified list. In July 2013, the 
Partnership for Patients--a new public-private partnership funded 
through the Affordable Care Act--responded by releasing a list of the 9 
most common medical errors \2\:

    1. Adverse Drug Events;
    2. Catheter-Associated Urinary Tract Infections;
    3. Central Line-Associated Blood Stream Infections;
    4. Injuries from Falls and Immobility;
    5. Obstetrical Adverse Events;
    6. Pressure Ulcers (Bedsores);
    7. Surgical Site Infections;
    8. Venous Thromboembolism (Blood Clots); and
    9. Ventilator-Associated Pneumonia.

    On February 4, 2014, Senator Boxer wrote to 283 California acute 
care hospitals asking them to respond with the actions they are taking 
to reduce these nine most common medical errors. She was pleased that 
nearly 53 percent of those surveyed--149 hospitals--responded to the 
inquiry, and she will continue to seek answers from those that failed 
to reply.\3\
    Here are some of the major findings:

     All of the hospitals that responded reported taking at 
least some steps to address the most common medical errors.
     Many hospitals agree on common approaches to reducing 
these errors, which are outlined in this report.
     Some hospitals are stepping out and pursuing unique 
approaches to preventing these errors.
     For example, Kaiser Permanente requires nurses to wear 
colored sashes or vests when dispensing medication to patients to 
prevent interruptions and distractions that could lead to errors.
     UCLA Medical Center disinfects hospital rooms using 
ultraviolet technology, prohibits the use of home-laundered scrubs, and 
bans doctors and other staff with open wounds, bandages or casts from 
scrubbing into surgeries to help prevent infection.
     And Desert Valley Hospital in Victorville reported that it 
reduced the number of surgical site infections from 16 in 2009 to 2 in 
2013 after starting an innovative program that rewards medical staff 
who are observed practicing good hand hygiene by entering them into a 
drawing for a chance to win a prize.
    Many more examples of how hospitals are responding to this epidemic 
are contained in this report. Senator Boxer believes that publicizing 
these best practices will save lives and encourage other hospitals to 
take these and other common-sense steps to reduce medical errors.
    Senator Boxer thanks all the hospitals that participated, as well 
as the Patient Safety Movement Foundation and the family of Leah 
Alexander, who helped to bring this issue to her attention. She has 
pledged to continue to focus attention on this issue to help prevent 
these needless tragedies.
              ii. taking action to prevent medical errors
    Based on the hospitals' responses to Senator Boxer's letter, the 
Senator's staff identified some common themes in how hospitals are 
addressing medical errors, as well as some of the challenges they face:
Checklists
    Several of the nine preventable medical errors have well-known 
interventions and ``checklists'' that many hospitals follow. Many 
hospitals indicated that they use these uniform checklists and 
``bundle'' systems for Ventilator-Associated Pneumonia, Catheter-
Associated Urinary Tract Infection, and Central Line Blood Stream 
Infection. However, hospitals did not cite the use of similar 
interventions in the cases of Falls, Adverse Drug Events and 
Obstetrical Adverse Events.
Identifying safe practices
    Implementing safe practices under one set of preventable medical 
errors often has beneficial effects in reducing another type of medical 
error. For example, venous thrombosis prevention was cited as an 
intervention to reduce ventilator-associated pneumonia.
Changing the culture
    General responses by the hospitals include a cultural change to 
focus on system-wide fixes rather than assigning blame, peer review 
committees to review cases of medical errors, weekly ``harm reports,'' 
daily safety huddles, and creating new bonds of collaboration both 
inside and outside of an organization.
Alarm fatigue
    Many hospitals cited ``Alarm Fatigue'' as a top patient safety 
concern, when health care workers become desensitized to a large volume 
of equipment alarms.
Stopping infections
    For infection control, use of chlorhexidine antiseptic on the skin 
was the most common intervention cited.
             iii. detailed findings from hospital responses
    To better understand how California hospitals are addressing these 
challenges, we broke down their responses to each of the most common 
medical errors identified by the Partnership for Patients:
Adverse Drug Events
    A preventable adverse drug event is a harm experienced by a patient 
as a result of exposure to a medication through medical error. Adverse 
drug events affect nearly 5 percent of hospitalized patients, making 
them one of the most common types of medical error.\4\

 
------------------------------------------------------------------------
             Common Approaches                    Unique Approaches
------------------------------------------------------------------------
Use barcode technologies and electronic     Require all inpatient nurses
 health records with computerized            to wear a colored sash or
 prescriber order entry, which helps to      vest to prevent
 eliminate errors due to illegible           interruptions and
 handwriting and works to promote            distractions during
 standardization of medications and dosage.  medication administration.
                                            Independently verify high-
                                             risk medications and doses
                                             by at least two clinicians
                                             prior to administration.
Actively involve pharmacists throughout a   Employ smart IV infusion
 patient's hospitalization, from reviewing   pumps that use drug
 the medications a patient is on at          libraries to warn the
 admission to reviewing a patient's          clinicians when they have
 electronic health record for prescribing    programmed the infusion
 errors.                                     pump outside safe
                                             parameters.
------------------------------------------------------------------------

            Example of Hospitals Using Unique Approaches
    Sutter Health reports a 59 percent improvement overall in Adverse 
Drug Events with Harm since joining the Partnership for Patients in 
2012. As part of that effort, Sutter Health has employed smart IV 
infusion pumps. According to Sutter Health, ``In 2013, the smart pump 
technology led to 2,778 severe harms averted systemwide.''
Catheter-Associated Urinary Tract Infections
    A urinary tract infection is ``an infection involving any part of 
the urinary system, including urethra, bladder, ureters, and kidney.'' 
\5\ According to the Centers for Disease Control and Prevention (CDC), 
among urinary tract infections acquired in the hospital, approximately 
75 percent are associated with a urinary catheter, which is a tube 
inserted into the bladder through the urethra to drain urine. Between 
15-25 percent of hospitalized patients receive urinary catheters during 
their hospital stay.

 
------------------------------------------------------------------------
             Common Approaches                    Unique Approaches
------------------------------------------------------------------------
Use sterile or ``clean'' technique during   Allow nurses to remove
 insertion and during catheter care.         catheters using approved
                                             guidelines without a
                                             physician order to expedite
                                             the removal of unnecessary
                                             catheters.
Assess catheter necessity daily...........  Set a standing time to
                                             remove catheters post
                                             operatively (e.g., 2 days
                                             after surgery) unless a
                                             surgeon directs otherwise.
Maintain hand hygiene
------------------------------------------------------------------------

            Example of Hospitals Using Unique Approaches
    Hemet Valley Medical Center has reduced their catheter-associated 
urinary tract infection rate in the ICU from 2.28 per 1,000 catheter-
days in 2011 to 1.72 per 1,000 catheter-days in 2013. They reported, 
``We have also drafted a standing order to allow nurses to remove foley 
catheters per approved guidelines in order to expedite the removal of 
foley catheters. This is in the process of being approved by our 
medical staff and the expectation is that this will further reduce our 
rate of infections.''
Central Line-Associated Blood Stream Infections
    A central line is a catheter placed into a large vein in the neck, 
chest, or groin. According to the CDC, ``an estimated 41,000 central 
line-associated bloodstream infections occur in U.S. hospitals each 
year. These infections are usually serious infections typically causing 
a prolongation of hospital stay and increased cost and risk of 
mortality.\6\

 
------------------------------------------------------------------------
             Common Approaches                    Unique Approaches
------------------------------------------------------------------------
Use disinfection caps or central line anti- Include a checklist in the
 microbial IV port covers.                   patient's electronic health
                                             record.
Use maximal sterile barriers: Cap, mask,    Train staff how to insert a
 gown, gloves, drape.                        central line in a
                                             simulation center.
Maintain hand hygiene.....................  Have an infection control
                                             specialist check a
                                             patient's line multiple
                                             times a week and/or watch
                                             during placement to ensure
                                             that the sterile technique
                                             is followed.
Use appropriate skin preparation agent and
 allow it to dry
Use chlorhexidine baths and cloths
------------------------------------------------------------------------

            Example of Hospitals Using Unique Approaches
    Olympia Medical Center reports that it has achieved zero central 
line infections over the last 6 months. Olympia Medical Centers writes 
that part of its efforts include that an ``Infection Control 
Practitioner checks each line three times a week, as well as watching 
during placement for sterile technique.''
    UC San Diego Health System formed a task force to address Central 
Line-Associated Blood Stream Infections. According to its response 
letter, UC San Diego Health System

        ``built a tool within the electronic medical record (EMR) for 
        documenting Central Line Insertion Practice (CLIP) bundle 
        performance at the time of central line insertions placed in 
        inpatient care sites as well as the emergency departments. This 
        tool prompts providers to comply with required bundle elements 
        and facilitates accurate data abstraction.''

Injuries from Falls and Immobility
    Each year, between 700,000 and 1 million people in the United 
States fall in the hospital. A fall may result in fractures, 
lacerations, or internal bleeding, leading to increased hospital stays 
and healthcare costs. According to the AHRQ, research shows that close 
to one-third of falls can be prevented.\7\

 
------------------------------------------------------------------------
             Common Approaches                    Unique Approaches
------------------------------------------------------------------------
Educate patients and their families.......  Use bed, chair, and portable
                                             alarms for high-risk
                                             patients.
Assign risk to patients based on a scoring  Use ``fall bands'' on the
 system.                                     arms of patients or colored
                                             socks to identify that
                                             these patients are high
                                             risk.
                                            Place high-risk patients in
                                             rooms closer to nursing
                                             stations.
                                            Establish an early mobility
                                             plan in the ICU to help
                                             mobilize patients earlier
                                             and prevent muscle
                                             weakness.
                                            Incorporate fall prevention
                                             education in new employee
                                             orientation.
------------------------------------------------------------------------

            Example of Hospitals Using Unique Approaches
    Riverside County Regional Medical Center has taken numerous steps 
to reduce the number of injuries from falls. According to the Riverside 
County Regional Medical Center,

          ``Some of these were the assigning of a `fall score' to 
        patients, placing patients closer to the nursing stations and 
        utilizing a `sitter' if necessary. Also colored arm bands are 
        used to identify those patients that are a high fall risk. 
        There is also the `Early Mobility' plan in the ICU to mobilize 
        patients earlier to prevent muscle weakness and assist in the 
        prevention of ventilator associated pneumonia.''
Obstetrical Adverse Events
    One of the most common obstetrical adverse events involves early 
elective delivery. According to the Leapfrog Group,

          ``A recent review of the evidence has shown that these 
        elective deliveries can have serious negative consequences for 
        the mother and baby.'' \8\

Ways that obstetrical medical errors can harm the mother include a 
higher risk of having a cesarean section as well as a higher risk of 
postpartum complications, such as anemia and endometriosis. Babies born 
at 37-38 weeks are at much higher risk of death. They are also at a far 
higher risk for harms like respiratory problems and admission to the 
neonatal intensive care unit (NICU).

 
------------------------------------------------------------------------
             Common Approaches                    Unique Approaches
------------------------------------------------------------------------
Establish a ``hard-stop'' policy (e.g., 39  Initiate drills and training
 weeks) to allow low-risk pregnant           using simulation equipment
 patients to go into spontaneous labor in    and specialty-trained
 order to reduce the rate of early           teams.
 elective deliveries.                       Conduct emergency drills for
                                             situations like postpartum
                                             hemorrhage.
                                            Debrief after emergency
                                             situations with
                                             multidisciplinary team.
                                            Reduce cesarean delivery
                                             among first-time moms.
------------------------------------------------------------------------

            Example of Hospitals Using Unique Approaches
    Kaiser Permanente implemented a Perinatal Patient Safety Program in 
2003. Kaiser writes that this program includes ``implementation of the 
National Institute of Child Health and Human Development (NICHD) fetal 
monitoring nomenclature and standardized simulation-based education to 
address high-risk adverse events (e.g., shoulder dystocia, instrument-
assisted deliveries, postpartum hemorrhage, etc.).''
Pressure Ulcers
    A pressure ulcer, or bed sore, is an injury usually caused by 
unrelieved pressure that damages the skin and underlying tissue.\9\ 
They can range from mild (minor skin reddening) to severe (deep craters 
down to muscle and bone). According to the AHRQ, ``The estimated cost 
to treat a pressure ulcer is between $500 and $40,000. Yet, pressure 
ulcers can be managed and prevented.\10\

 
------------------------------------------------------------------------
             Common Approaches                    Unique Approaches
------------------------------------------------------------------------
Assess all patients for pressure ulcers     Use of low air loss surfaces
 prior to and upon admission.                (e.g., using air mattresses
                                             on emergency stretchers for
                                             high-risk patients).
Nursing staff should discuss pressure       Use of turn logs and turn
 ulcers during shift reports.                clocks as a reminder to
                                             reposition the patient.
                                            Employ a wound care team.
------------------------------------------------------------------------

            Example of Hospitals Using Unique Approaches
    Cedars-Sinai reports a 74 percent reduction in pressure ulcers, to 
less than a dozen annually. Cedars-Sinai notes,

          ``The nursing department lead the effort to achieve this 
        reduction in pressure ulcers by executing the following list of 
        actions: (1) improved clinician education, (2) standardized 
        pressure ulcer assessment, staging, and reporting, (3) 
        implemented triggers for additional interventions such as 
        nutrition consults, (4) and improved the procurement and 
        distribution of appropriate support surfaces and skin care 
        products throughout the facility.''
Surgical Site Infections
    According to the CDC, a recent study found that surgical site 
infections were the most common healthcare-associated infection, 
accounting for 31 percent of all of these infections among hospitalized 
patients. In addition, one study found 16,147 surgical site infections 
following 849,659 operative procedures.\11\

 
------------------------------------------------------------------------
             Common Approaches                    Unique Approaches
------------------------------------------------------------------------
Use chlorhexidine baths or showers in lieu  Prohibit staff with open
 of regular tub baths.                       wounds, bandages, or casts
                                             from scrubbing in to
                                             surgical cases.
Maintain normal blood sugar post-           Conduct black light
 operatively.                                inspections on a random
                                             sample of operating rooms
                                             after cleaning.
Eliminate unnecessary foot traffic during   Minimize blood transfusions.
 the surgical period that ranges from
 anesthesia administration through
 recovery.
Use proper hair removal techniques and      Use rotating staff and
 ensure minimal skin trauma related to       ``secret shoppers'' for
 hair removal.                               hand hygiene observations
                                             (i.e. the more times staff
                                             are observed washing their
                                             hands, the more likely they
                                             are to win a prize).
------------------------------------------------------------------------

            Example of Hospitals Using Unique Approaches
    UCLA Health System has seen an 18 percent improvement in surgical 
site infections from 2010 to 2013. Part of the UCLA effort to reduce 
medical errors includes an enhanced operating room attire policy which 
prohibits the use of home-laundered scrubs. Additionally,

          ``MDs and staff with open wounds, bandages or casts on their 
        hands may not scrub in to surgical cases as their hands are not 
        able to be adequately decontaminated.''

    Desert Valley Hospital reports that it reduced the number of 
surgical site infections from 16 in 2009 down to 2 in 2013. Desert 
Valley Hospital attributes part of this success to an effort that 
``created the CSI (control the spread of infection) Program house-
wide.'' The CSI program runs the ``secret shopper'' and staff prize 
model for rewarding hand hygiene.
Venous Thromboembolism
    Venous thromboembolism is a condition that includes both deep vein 
thrombosis and pulmonary embolism. Deep vein thrombosis is the 
formation of a blood clot in a deep vein, usually in the leg or pelvis. 
The most serious potential complication of a deep vein thrombosis is 
the possibility that the clot could dislodge and travel to the lungs, 
becoming a pulmonary embolism.\12\ According to AHRQ, venous 
thromboembolism is the most common preventable cause of hospital 
death.\13\

 
------------------------------------------------------------------------
             Common Approaches                    Unique Approaches
------------------------------------------------------------------------
Employ wound care specialists.............  Have pharmacy department
                                             follow all patients with
                                             venous thromboembolism.
Assess patients for risk pre-operatively..  Reduce unnecessary central
                                             venous catheter days and
                                             minimize the size of these
                                             catheters.
                                            Have the electronic health
                                             record prompt the clinician
                                             to order deep-vein
                                             thrombosis prevention
                                             (mechanical intervention or
                                             pharmaceutical
                                             intervention) or to
                                             document the reasons why it
                                             was not ordered.
------------------------------------------------------------------------

            Example of Hospitals Using Unique Approaches
    UC San Diego Health System reports that central venous catheters 
(CVCs) are frequently associated with deep vein thrombosis of the upper 
limbs. So the hospital system reports that it is

        ``striving to reduce unnecessary central venous catheter (CVC) 
        days, minimize the size of CVCs, and ensure proper CVC 
        insertion technique.''
Ventilator-Associated Pneumonia
    According to the CDC,

          ``Ventilator-associated pneumonia is a lung infection that 
        develops in a person who is on a ventilator. A ventilator is a 
        machine that is used to help a patient breathe by giving oxygen 
        through a tube placed in a patient's mouth or nose, or through 
        a hole in the front of the neck. An infection may occur if 
        germs enter through the tube and get into the patient's 
        lungs.'' \14\

    The CDC also notes that in 2002, 250,000 healthcare-associated 
pneumonias developed in hospitals and were connected to 36,000 
deaths.\15\

 
------------------------------------------------------------------------
             Common Approaches                    Unique Approaches
------------------------------------------------------------------------
Elevate the patient's head 30-45 degrees..  Use percussion vest in the
Institute a daily ``sedation vacation''...   ICU to help wean patients
                                             off of the ventilator more
                                             quickly.
Assess the patient's readiness to extubate  Make effort to keep patients
 daily.                                      extubated if they have
Maintain oral hygiene regularly...........   removed their own tube for
                                             any reason.
Prevent deep vein thrombosis..............  Avoid gastric over-
                                             distention, when too much
                                             air is allowed into the
                                             stomach.
------------------------------------------------------------------------

            Example of Hospitals Using Unique Approaches
    University of California, Davis Medical Center reports that it has 
achieved a 76 percent reduction in Ventilator-Associated Pneumonia from 
2009-13. According to the UC Davis Medical Center response letter, this 
effort includes ``Quality and Safety Champions'' who ``attend 
multidisciplinary rounds, monitor bundle compliance at the bedside for 
healthcare practitioners at all levels and provide `just-in-time' 
coaching.''
 iv. congressional and administrative actions to reduce medical errors
    The 2010 health reform law, the Affordable Care Act, is saving 
lives and reducing medical errors. The law led to the creation of the 
Partnership for Patients, which is dedicating $1 billion to prevent 
hospital-acquired conditions. The Affordable Care Act has also created 
three new pay-for-performance programs, which will reward hospitals 
that deliver high-quality care and penalize those that fail to reduce 
medical errors.
    Outlined below are recent congressional actions aimed at reducing 
medical errors, including those enacted by the health reform law.
     Since 2003, as a condition of participation in the 
Medicare program, Federal regulations require that hospitals maintain a 
Quality Assessment and Performance Improvement (QAPI) program to 
``track medical errors and adverse patient events, analyze their 
causes, and implement preventive actions and mechanisms that include 
feedback and learning throughout the hospital.'' \16\ A January 2012 
report by the Department of Health and Human Services' Office of the 
Inspector General found in a survey that staff did not report 86 
percent of events to incident reporting systems, partly because of 
misperceptions about what constitutes patient harm.\17\ In 2011, CMS 
launched the Hospital Patient Safety initiative, in which they are 
piloting new surveyor tools for assessing compliance with Federal 
regulations.\18\
     The Hospital Inpatient Quality Reporting was originally 
added to Federal law by the Medicare Prescription Drug, Improvement and 
Modernization Act and was later amended by the Deficit Reduction Act of 
2005.\19\ Under this program, CMS pays hospitals that successfully 
report designated quality measures a higher annual update, and failure 
to report the measures results in a payment reduction. Once the data is 
received from hospitals, CMS publicly reports the data on its 
``Hospital Compare'' Web site.
     The Deficit Reduction Act of 2005 required CMS to select 
at least two hospital-acquired conditions for which hospitals would not 
be paid higher Medicare reimbursement.\20\ Since 2008, CMS has 
maintained a list of hospital-acquired conditions that includes 
catheter-associated urinary tract infections, falls and trauma, late-
stage pressure ulcers, surgical site infections, and deep vein 
thromboembolism.\21\ Under the Patient Protection and Affordable Care 
Act of 2009, starting in 2011, CMS has applied this payment policy to 
the Medicaid program to encourage hospitals to actively prevent these 
conditions.
     The Patient Safety and Quality Improvement Act of 2005 
established Patient Safety Organizations under supervision of the AHRQ. 
Patient Safety Organizations receive reports of patient safety events 
from health care providers and provide analyses of these events.\22\ 
They also operate under Federal privacy protections to encourage 
providers to report medical errors and to work with health systems to 
resolve systemic issues.
     The Patient Safety and Quality Improvement Act of 2005 
also authorized AHRQ to promulgate ``Common Formats'' so that hospitals 
can report adverse events in a uniform, unambiguous manner.\23\ The 
goal of Common Formats is to allow for the ``apples to apples'' 
comparison of medical errors across multiple hospital systems.
     The Patient Protection and Affordable Care Act created the 
CMS Innovation Center for the purpose of testing ``innovative payment 
and service delivery models to reduce program expenditures . . . while 
preserving or enhancing the quality of care'' for those individuals who 
receive Medicare, Medicaid, or Children's Health Insurance Program 
(CHIP) benefits.'' \24\ The CMS Innovation Center, now known as the 
Center for Medicare & Medicaid Innovation, provided $1 billion in 
funding for the Partnership for Patients, a public-private partnership 
to improve the quality of health care. The Partnership has published a 
list of the nine most common and harmful medical errors. The goals of 
the Partnership are to reduce medical errors by 40 percent and re-
admissions by 20 percent.
     The Patient Protection and Affordable Care Act also 
authorized three pay-for-performance programs that will adjust Medicare 
payments to hospitals based on the quality of care delivered. The 
Hospital Readmission Reduction Program began in October 2012 and 
penalizes hospitals with higher-than-expected re-admissions for 
beneficiaries initially admitted for selected conditions. The Value 
Based Purchasing Program \25\ began in October 2012 and provides 
penalties as well as incentive payments based on hospitals' performance 
on quality measures, including reducing surgical site infections. The 
Hospital-Acquired Condition Reduction Program \26\ will reduce payments 
to hospitals that are in the top quartile for hospital-acquired 
conditions starting on October 1, 2014. CMS has adopted AHRQ safety 
indicators encompassing pressure ulcer rate and deep vein thrombosis 
rate, among others, as well as measures from the CDC, such as central 
line-associated blood stream infection and catheter-associated urinary 
tract infections.\27\
                           v. recommendations
    1. All Federal programs designed to reduce medical errors should 
work off a single list where appropriate, specifically the Partnership 
for Prevention's list of the nine most common medical errors.
    2. The Department of Health and Human Services should report to 
Congress the time it takes for quality measures to be developed, 
endorsed, and ultimately implemented in programs related to medical 
error reduction. A strategy for how to accelerate this process should 
also be included.
    3. In the next round of regulations for electronic health records, 
the Office of the National Coordinator should include a standard way of 
reporting medical errors, specifically the Common Formats developed by 
AHRQ. This will allow hospitals and researchers to better collect data 
on errors, their frequency, and where they are occurring.
    4. When assessing whether hospitals are meeting the requirement to 
track and report adverse events as a condition of participation in the 
Medicare program, surveyors and accreditors should evaluate the 
information collected by hospitals using AHRQ's Common Formats.
    5. Congress should review the adequacy of whistleblower protections 
to ensure that health care providers are able to report medical errors 
without retribution.
    6. The Department of Health and Human Services' Office of the 
Inspector General should examine the Hospital Patient Safety 
Initiative's new surveyor tools and analyze their impact on increasing 
staff reporting of medical errors.
                             vi. conclusion
    Preventing medical errors will not only save lives, it will also 
improve the quality of health care for all Americans.
    And it is not just a moral imperative to act--it is an economic 
necessity. One study estimated that the direct costs of medical errors 
totaled $19.5 billion annually.\28\ Another study found that all of the 
costs of medical errors, including lost productivity, could amount to 
$1 trillion annually.\29\ By stopping these errors before they occur, 
we can save taxpayers, businesses and our health care system billions 
of dollars each year.
    In the Jewish tradition, there is a saying: ``Whoever saves a 
life--it is as if that person has saved the whole world.'' Today, we 
have the opportunity to save a life over and over again. We have the 
chance to save hundreds of thousands of lives and prevent heartbreak 
and pain for so many families.
    If we work together, we can prevent these needless tragedies. If we 
ensure that doctors, nurses, hospital administrators, medical 
technology leaders, Federal officials and patient advocates are all 
focused on this common goal, we can make great progress in preventing 
these avoidable deaths and ending the epidemic of medical errors in 
this country.
                             vii. citations
    1. Centers for Disease Control and Prevention, National Vital 
Statistics Reports. Volt. 62, No. 6, December 20, 2013.
    2. Top 9 medical errors were outlined by the Partnership for 
Patients. http://partnershipforpatients.cms.gov/about-the-partnership/
what-is-the-partnership-about
/lpwhat-the-partnership-is-about.html.
    3. Senator Boxer's letter to California hospitals. http://
www.boxer.senate.gov/en/press/releases/020414a.cfm.
    4. AHRQ Patient Safety Primer: Medication Errors. http://
psnet.ahrq.gov/primer. aspx?primerID=23.
    5. Centers for Disease Control and Prevention. Definition of 
Catheter-associated Urinary Tract Infections (CAUTI). http://
www.cdc.gov/HAI/ca_uti/uti.html.
    6. Centers for Disease Control and Prevention. ``Device-associated 
Module: CLABSI''. http://www.cdc.gov/nhsn/pdfs/pscmanual/
4psc_clabscurrent.pdf.
    7. AHRQToolkit: Preventing Falls in Hospitals. http://www.ahrq.gov/
professionals/systems/long-term-care/resources/injuries/fallpxtoolkit/
index.html.
    8. The Leapfrog Group. ``Early Elective Deliveries.'' https://
leapfroghospital
survey.org/web/wp-content/uploads/FSdeliveries.pdf.
    9. Agency for Healthcare Research and Quality. ``What is a Pressure 
Ulcer?'' http://www.ahrq.gov/patients-consumers/prevention/
understanding/bodysys/ed
body6.html.
    10. Agency for Healthcare Research and Quality. What's New. March 
3, 2010. http://innovations. ahrq.gov/issue.aspx?id=76.
    11. Centers for Disease Control and Prevention. ``Procedure-
associated Module: SSI''. http://www. cdc.gov/nhsn/pdfs/pscmanual/
9pscssicurrent.pdf.
    12. Johns Hopkins Medicine, Center for Innovation in Quality 
Patient Care. ``What is DVT/VTE?'' http://www.hopkinsmedicine.org/
innovation_quality_patient
_care/areas_expertise/infections_complications/dvt/
what_is_dvt_vte.html.
    13. Agency for Healthcare Research and Quality. ``Preventing 
Hospital-Acquired Venous Thromboembolism: A Guide for Effective Quality 
Improvement.'' http://www.ahrq.gov/professionals/quality-patient-
safety/patient-safety-resources/resources/vtguide/index.html.
    14. Centers for Disease Control and Prevention. ``Ventilator-
associated Pneumonia (VAP)''. http://www.cdc.gov/hai/vap/vap.html.
    15. Centers for Disease Control and Prevention. ``Device-associated 
Events: VAP''. http://www.cdc.gov/nhsn/pdfs/pscmanual/
6pscvapcurrent.pdf.
    16. CFR Sec. 482.21.
    17. Department of Health and Human Services' Office of the 
Inspector General ``Hospital Incident Reporting Systems Do Not Capture 
Most Patient Harm.'' January 2012.
    18. Centers for Medicare & Medicaid Services Letter to State Survey 
Agency Directors November 9, 2012. http://www.cms.gov/Medicare/
Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/
Downloads/Survey-and-Cert-Letter-13-03
.pdf.
    19. Pub. L. 108-173 section 501(b) and Pub. L 109-171 section 
5001(a).
    20. Pub. L. 109-171 section 5001(c).
    21. Centers for Medicare & Medicaid Services ``FY 2013 Final HAC 
List''. http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/
HospitalAcqCond/Down-
loads/FY_2013_Final_HACsCodeList.pdf.
    22. Pub. L. 109-41 section 924 as added to the Public Health 
Service Act.
    23. Pub. L. 109-41 section 923(b) as added to the Public Health 
Service Act.
    24. Pub. L. 111-148 Section 3021, adding SSA section 1115A.
    25. Pub. L. 111-148 section 3001.
    26. Pub. L. 111-148 section 3008.
    27. Centers for Medicare & Medicaid Services Fiscal Year 2014 final 
rule for hospital inpatient prospective payment systems. Federal 
Register/Volt. 78, No. 160/Monday, August 19, 2013.
    28. American Society of Actuaries ``The Economic Measurement of 
Medical Errors'' 2010, available at http://www.soa.org/research/
research-projects/health/research-econ-measurement.asp.
    29. Andel C, Davidow SL, Hollander M, Moreno DA. ``The economics of 
health care quality and medical errors.'' Journal of Health Care 
Finance. 2012 Fall;
39(1):39-50.
Response to Questions of Senator Warren by Peter Pronovost, M.D., Ph.D.
    Collecting accurate and timely data is essential for initiatives 
that seek to improve patient safety and the quality of patient care. 
Work to curb hospital-acquired infections relies heavily on meaningful, 
real-time data--because a hospital can't address a problem if they 
don't know it's there.
    The Food and Drug Administration (FDA) is also working to collect 
better data in order to improve patient safety. The FDA's Sentinel 
Initiative currently uses information from insurance claims to 
proactively identify adverse events and to evaluate the safety of 
prescription drugs after they are on the market. Starting later this 
year, the FDA will begin to require that medical devices carry a Unique 
Device Identifier, or UDI. This special number on devices will help 
hospitals and providers identify and track individual devices as they 
are used in patients and holds great promise for improving patient 
safety.

    Question 1. What steps can we take to ensure that new UDI data can 
be used efficiently and immediately to improve patient safety?
    Answer 1. The UDI system will facilitate recall resolution, improve 
the accuracy of adverse event reports, enhance care coordination among 
multiple physicians caring for the same patient and enable more 
sophisticated postmarket surveillance. To achieve these benefits, 
though, UDI must be included in electronic health information--
particularly patients' electronic health records (EHRs) and claims; 
imposing minimal burden and realizing significant value.
    Currently, patients' health records lack a standardized way to list 
the devices implanted in patients. Creating a field in EHRs for UDI 
will provide hospitals, doctors and patients with accurate information 
on the devices implanted in patients. If needed, providers could use 
this information to contact patients with recalled products and deliver 
appropriate followup care. Similarly, these data will help clinicians 
know which devices are implanted in their patients, especially for 
patients that see multiple providers. UDI data from EHRs will also 
provide patients and physicians with more precise data to submit more 
accurate adverse event reports, which currently often lack critical 
data on the make, model and lot number of potentially malfunctioning 
devices. Last, hospitals can utilize data from EHRs to conduct their 
own analyses on product performance.
    Similarly, claims data lack information on the precise devices used 
in care. For example, a claim may indicate that a patient received a 
hip replacement, but the claim lacks information on the specific device 
implanted. Including a field for UDI in claims will provide payers with 
data on the products implanted in their beneficiaries. When a recall 
occurs, the health plan--which often has up-to-date contact 
information--can ensure that the patient is notified and receives 
appropriate followup care. Additionally, health plans could conduct 
their own analyses on device performance, as they currently do with 
drugs.
    Last, the Food and Drug Administration's (FDA's) Sentinel program 
could also be utilized to evaluate device safety, as directed by 
Congress in 2012. Sentinel relies predominantly on claims, which as 
previously stated, lack information on devices used. Should claims 
include UDI data, Sentinel would have the necessary information to 
analyze device information as is currently done with drugs and 
biologics.
    Claims have limitations and should not be the sole method of 
conducting postmarketing surveillance. However, unlike other sources of 
data, claims contain standardized, longitudinal data on large numbers 
of patients that may see multiple providers. Analyses of claims are an 
important tool that--in concert with adverse event reports, EHR data, 
registries and other tools--can protect patients from unsafe or 
ineffective products.

    Question 2. Can UDI information be incorporated into the Sentinel 
system to evaluate the safety of medical devices after they are on the 
market?
    Answer 2. The FDA's Sentinel system has been successfully used to 
identify problems with drugs and biologics. For example, FDA added 
warnings to a blood pressure medicine (olmesartan medoxomil) for 
intestinal problems (sprue-like enteropathy) based on Sentinel 
findings. Sentinel cannot, though, currently efficiently evaluate the 
safety of medical devices.
    This is because Sentinel's primary data source is claims. While 
claims usually include data on many of the drugs patients receive, 
claims lack information about medical devices patients receive. For 
Sentinel to efficiently evaluate device performance, as directed by 
Congress, claims must include a field for the UDI of implanted devices 
used in care and providers must use that field to send information to 
health plans. With that data, Sentinel would have the necessary 
information on devices to conduct analyses, to learn, and to improve.

    [Whereupon, at 11:37 a.m., the hearing was adjourned.]

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