[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
SUBCOMMITTEE ON PRIMARY HEALTH AND AGING
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED THIRTEENTH CONGRESS
EXAMINING THE NEED TO IMPROVE PATIENT SAFETY AND REDUCE PREVENTABLE
JULY 17, 2014
Printed for the use of the Committee on Health, Education, Labor, and
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.gpo.gov/fdsys/
U.S. GOVERNMENT PUBLISHING OFFICE
88-894 PDF WASHINGTON : 2016
For sale by the Superintendent of Documents, U.S. Government Publishing Office
Internet: bookstore.gpo.gov. Phone: toll free (866) 512-1800; DC area (202)512-1800
Fax: (202) 512-2104 Mail: Stop IDCC, Washington, DC 20402-0001
COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
TOM HARKIN, Iowa, Chairman
BARBARA A. MIKULSKI, Maryland LAMAR ALEXANDER, Tennessee
PATTY MURRAY, Washington MICHAEL B. ENZI, Wyoming
BERNARD SANDERS (I), Vermont RICHARD BURR, North Carolina
ROBERT P. CASEY, JR., Pennsylvania JOHNNY ISAKSON, Georgia
KAY R. HAGAN, North Carolina RAND PAUL, Kentucky
AL FRANKEN, Minnesota ORRIN G. HATCH, Utah
MICHAEL F. BENNET, Colorado PAT ROBERTS, Kansas
SHELDON WHITEHOUSE, Rhode Island LISA MURKOWSKI, Alaska
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
C O N T E N T S
THURSDAY, JULY 17, 2014
Sanders, Hon. Bernard, Chairman, Subcommittee on Primary Health
and Aging, opening statement................................... 1
Warren, Hon. Elizabeth, a U.S. Senator from the State of
Whitehouse, Hon. Sheldon, a U.S. Senator from the State of Rhode
James, John T., Ph.D., Founder, Patient Safety America, Houston,
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
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
MORE THAN 1,000 PREVENTABLE DEATHS A DAY IS TOO MANY: THE NEED TO
IMPROVE PATIENT SAFETY
THURSDAY, JULY 17, 2014
Subcommittee on Primary Health and Aging,
Committee on Health, Education, Labor, and Pensions,
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
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
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
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
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.
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
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
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
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
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
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
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
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
To know the safety record of their physician, outpatient
clinic, nursing home, and hospital.
To know costs for tests and elective procedures before
To transparent accountability in the case of an adverse
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
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
STATEMENT OF ASHISH K. JHA, M.D., MPH, PROFESSOR OF HEALTH
POLICY AND MANAGEMENT, HARVARD SCHOOL OF PUBLIC HEALTH, BOSTON,
Dr. Jha. It's my pleasure. Thank you, Senator Sanders.
And, Senator Warren, thank you for that very warm
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
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
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
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
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.
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.
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
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
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
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.
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
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.
6. Pronovost P, Needham D, Berenholtz S, et al. An intervention to
decrease catheter-related bloodstream infections in the ICU. N Engl J
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
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,
12. Jha AK, Classen DC. Getting moving on patient safety--
harnessing electronic data for safer care. N Engl J Med.
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.
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/
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-
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
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
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
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
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
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/
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
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
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/
Better-Care.aspx) and the Office of the National Coordinator (http://
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
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.
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
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
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
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
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
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
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
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
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
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
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
``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
Invest in the science of health care delivery, including
supporting learning labs to make the Boeing or Lockheed Martin of
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.
1. Fineberg HV. Shattuck lecture. A successful and sustainable
health system--how to get there from here. N Engl J Med. 2012;366:1020-
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
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
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
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,
Ms. Disch. Good morning. Thank you, Chairman Sanders and
other members of the subcommittee, for hosting this very
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
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.
[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
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
2. Medication administration errors using infusion pumps.
3. Unnecessary exposures and radiation burns from diagnostic
4. Patient/data mismatches in EHRs and other health IT systems.
5. Interoperability failures with medical devices and health IT
6. Air embolism hazards.
7. Inattention to the needs of pediatric patients when using
8. Inadequate reprocessing of endoscopic devices and surgical
9. Caregiver distractions from smartphones and other mobile
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)
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
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
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
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,
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
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
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
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.
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
2. Engaging patients and their families in the care process.
3. Establishing a safety culture where every hospital is a High
Thank you for this opportunity to comment on this vital topic.
Agency for Healthcare Research & Quality (2008). Becoming a High
Reliability Organization: Operational Advice for Hospital Leaders.
Rockville, MD: AHRQ.
Agency for Healthcare Research & Quality (2010). AHRQ Nursing Home
Survey on Patient Safety Culture. Retrieved July 14, 2014 from
Aiken LH, Sloane DM, Bruyneel L, VandenHeede K, Griffiths P, & Sermeus
W. (2014). Nurse staffing and education and hospital mortality in
nine European countries: A retrospective observational study. The
Lancet, 383(9931), 1824-30. Retrieved July 10, 2014 from http://
Amalberti R, Auroy Y, Berwick D, & Barach P. (2005). Five system
barriers to achieving ultrasafe health care. Ann Intern Med, 142,
American Association of Colleges of Nursing (AACN) (2014). Nursing
shortage. Retrieved July 10, 2014 from http://www.aacn.nche.edu/
Baker DP, Day R, & Salas E (2006). Teamwork as an essential component
of high-reliability organizations. Health Serv Res, 41(4 pt 2),
1576-98. Retrieved July 10, 2014 from http://www.ncbi.nlm.nih.gov/
Balik, B, Conway, J, Zipperer, L, & Watson, J. (2011). Achieving an
exceptional patient and family experience of inpatient hospital
care. IHI Innovation Series white paper. Cambridge, Massachusetts:
Institute for Healthcare Improvement, 14.
Barnsteiner J. (2014). Overview and history of person- and family-
centered care. In Barnsteiner, Disch, & Walton (eds.) Person and
family-centered care. Indianapolis, IN: Sigma Theta Tau
Bureau of Labor Statistics (BLS) (2010). Occupational employment and
wages. Retrieved July 14, 2014 from http://www.bls.gov/oes/current/
Bureau of Labor Statistics (BLS) (2013). Employment Projections 2012-
22. Retrieved July 16, 2014 from http://www.bls.gov/news.release/
Chassin MR, & Loeb JM (2011). The ongoing quality improvement journey:
Next stop, High reliability. Health Affairs, 30(4), 559-68.
Chassin MR. & Loeb JM (2013). High-reliability health care: Getting
there from here. Milbank Quarterly, 91(3), 459-90.
Cronenwett L, Sherwood G, Barnsteiner J, Disch J, Johnson J, & Warren
J. (2007). Quality and safety education for nurses. Nursing
Outlook, 55(3), 122-131.
Disch J. (2012). Are we evidence-based when we like the evidence?
Nursing Outlook, 60(1), 3-4.
ECRI Institute (2013). Health Devices: Top 10 Health technology hazards
for 2013. Retrieved July 16, 2014 from https://www.ecri.org/
HRSA (Health Resources and Services Administration). 2010. The
registered nurse population: Findings from the 2008 National Sample
Survey of Registered Nurses. Rockville, MD: HRSA.
Institute of Medicine (1999). To err is human. Building a safer health
system. Washington, DC: National Academies Press.
Institute of Medicine (2011). The future of nursing: Leading change,
advancing health. Washington, DC: National Academies Press.
James JT (2013). A New, Evidence-based Estimate of Patient Harms
Associated with Hospital Care. Journal of Patient Safety, 9(3),
Makary M (2012). Unaccountable: What hospitals won't tell you and how
transparency can revolutionize health care. New York, NY:
Needleman J, Buerhaus PL, Stewart M, Zelevinsky K, & Mattke S. (2006).
Nurse Staffing In Hospitals: Is There A Business Case For Quality?
Health Affairs, 25(1), 204-2111.
Rosenstein AH, & O'Daniel M (2008). A survey of the impact of
disruptive behaviors and communication defects on patient safety.
The Jt Comm J on Qual and Pat Safety, 34(8), 464-71.
Sammer CE, Lykens K, Singh KP, Mains DA, & Lackan NA (2010). What is
patient safety culture? A review of the literature. J of Nsg Schol,
The Joint Commission (n.d.). Sentinel event data: Root causes by event
type, 2004-13. Retrieved July 16, 2014 from http://
[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
`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
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,''
``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
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
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
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
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
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
\1\ James JT, ``A new, evidence-based estimate of patient harms
associated with hospital care.'' Journal of Patient Safety, 2013
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
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
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
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;
\4\ MMWR Weekly, February 25, 2000; ``Fourth Decennial
International Conference on Nosocomial and Healthcare-Associated
\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
\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
\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
\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
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
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
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;
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
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.
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
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
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. 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
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
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
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
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
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. 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
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.
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
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
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.
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
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
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
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
Senator Sanders. You're talking about accreditation.
Dr. Pronovost. Correct. You'll be sanctioned or you'll lose
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
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
Senator Whitehouse. So how do you possibly get a signal out
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--
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
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
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
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
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
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
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
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
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
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. 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
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
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. 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
Senator Warren. Good.
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. 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
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
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. 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
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
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
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.
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.
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
Senator Sanders. Thank you all very much.
[Additional material follows.]
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
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:
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.
Many hospitals cited ``Alarm Fatigue'' as a top patient safety
concern, when health care workers become desensitized to a large volume
of equipment alarms.
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
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
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
Common Approaches Unique Approaches
Use disinfection caps or central line anti- Include a checklist in the
microbial IV port covers. patient's electronic health
Use maximal sterile barriers: Cap, mask, Train staff how to insert a
gown, gloves, drape. central line in a
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
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
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
Place high-risk patients in
rooms closer to nursing
Establish an early mobility
plan in the ICU to help
mobilize patients earlier
and prevent muscle
Incorporate fall prevention
education in new employee
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
Debrief after emergency
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.).''
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
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
Maintain normal blood sugar post- Conduct black light
operatively. inspections on a random
sample of operating rooms
Eliminate unnecessary foot traffic during Minimize blood transfusions.
the surgical period that ranges from
anesthesia administration through
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 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
Common Approaches Unique Approaches
Employ wound care specialists............. Have pharmacy department
follow all patients with
Assess patients for risk pre-operatively.. Reduce unnecessary central
venous catheter days and
minimize the size of these
Have the electronic health
record prompt the clinician
to order deep-vein
(mechanical intervention or
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
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
The CDC also notes that in 2002, 250,000 healthcare-associated
pneumonias developed in hospitals and were connected to 36,000
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
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
Prevent deep vein thrombosis.............. Avoid gastric over-
distention, when too much
air is allowed into the
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'
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
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
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
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
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
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.
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
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
3. Senator Boxer's letter to California hospitals. http://
4. AHRQ Patient Safety Primer: Medication Errors. http://
5. Centers for Disease Control and Prevention. Definition of
Catheter-associated Urinary Tract Infections (CAUTI). http://
6. Centers for Disease Control and Prevention. ``Device-associated
Module: CLABSI''. http://www.cdc.gov/nhsn/pdfs/pscmanual/
7. AHRQToolkit: Preventing Falls in Hospitals. http://www.ahrq.gov/
8. The Leapfrog Group. ``Early Elective Deliveries.'' https://
9. Agency for Healthcare Research and Quality. ``What is a Pressure
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/
12. Johns Hopkins Medicine, Center for Innovation in Quality
Patient Care. ``What is DVT/VTE?'' http://www.hopkinsmedicine.org/
13. Agency for Healthcare Research and Quality. ``Preventing
Hospital-Acquired Venous Thromboembolism: A Guide for Effective Quality
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/
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/
19. Pub. L. 108-173 section 501(b) and Pub. L 109-171 section
20. Pub. L. 109-171 section 5001(c).
21. Centers for Medicare & Medicaid Services ``FY 2013 Final HAC
22. Pub. L. 109-41 section 924 as added to the Public Health
23. Pub. L. 109-41 section 923(b) as added to the Public Health
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/
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;
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
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
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
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
Question 2. Can UDI information be incorporated into the Sentinel
system to evaluate the safety of medical devices after they are on the
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.]