[House Hearing, 107 Congress]
[From the U.S. Government Publishing Office]
HEALTH QUALITY AND MEDICAL ERRORS
=======================================================================
HEARING
before the
SUBCOMMITTEE ON HEALTH
of the
COMMITTEE ON WAYS AND MEANS
HOUSE OF REPRESENTATIVES
ONE HUNDRED SEVENTH CONGRESS
SECOND SESSION
__________
MARCH 7, 2002
__________
Serial No. 107-76
__________
Printed for the use of the Committee on Ways and Means
U. S. GOVERNMENT PRINTING OFFICE
81-751 WASHINGTON : 2003
____________________________________________________________________________
For Sale by the Superintendent of Documents, U.S. Government Printing Office
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COMMITTEE ON WAYS AND MEANS
BILL THOMAS, California, Chairman
PHILIP M. CRANE, Illinois CHARLES B. RANGEL, New York
E. CLAY SHAW, Jr., Florida FORTNEY PETE STARK, California
NANCY L. JOHNSON, Connecticut ROBERT T. MATSUI, California
AMO HOUGHTON, New York WILLIAM J. COYNE, Pennsylvania
WALLY HERGER, California SANDER M. LEVIN, Michigan
JIM McCRERY, Louisiana BENJAMIN L. CARDIN, Maryland
DAVE CAMP, Michigan JIM McDERMOTT, Washington
JIM RAMSTAD, Minnesota GERALD D. KLECZKA, Wisconsin
JIM NUSSLE, Iowa JOHN LEWIS, Georgia
SAM JOHNSON, Texas RICHARD E. NEAL, Massachusetts
JENNIFER DUNN, Washington MICHAEL R. McNULTY, New York
MAC COLLINS, Georgia WILLIAM J. JEFFERSON, Louisiana
ROB PORTMAN, Ohio JOHN S. TANNER, Tennessee
PHIL ENGLISH, Pennsylvania XAVIER BECERRA, California
WES WATKINS, Oklahoma KAREN L. THURMAN, Florida
J.D. HAYWORTH, Arizona LLOYD DOGGETT, Texas
JERRY WELLER, Illinois EARL POMEROY, North Dakota
KENNY C. HULSHOF, Missouri
SCOTT McINNIS, Colorado
RON LEWIS, Kentucky
MARK FOLEY, Florida
KEVIN BRADY, Texas
PAUL RYAN, Wisconsin
Allison Giles, Chief of Staff
Janice Mays, Minority Chief Counsel
______
Subcommittee on Health
NANCY L. JOHNSON, Connecticut, Chairman
JIM McCRERY, Louisiana FORTNEY PETE STARK, California
PHILIP M. CRANE, Illinois GERALD D. KLECZKA, Wisconsin
SAM JOHNSON, Texas JOHN LEWIS, Georgia
DAVE CAMP, Michigan JIM McDERMOTT, Washington
JIM RAMSTAD, Minnesota KAREN L. THURMAN, Florida
PHIL ENGLISH, Pennsylvania
JENNIFER DUNN, Washington
Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public
hearing records of the Committee on Ways and Means are also published
in electronic form. The printed hearing record remains the official
version. Because electronic submissions are used to prepare both
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C O N T E N T S
__________
Page
Advisory of February 27, 2002, announcing the hearing............ 2
WITNESSES
American Hospital Association, and Danbury Hospital, Matthew
Miller, M.D.................................................... 12
American Nurses Association, Mary Foley.......................... 23
Institute for Healthcare Improvement, Donald M. Berwick, M.D..... 17
Michigan Department of Veterans' Affairs, Veterans Health
Administration, James P. Bagian, M.D........................... 7
Pittsburgh Regional Healthcare Initiative, and Jewish Healthcare
Foundation of Pittsburgh, Karen Wolk Feinstein................. 28
__________
SUBMISSION FOR THE RECORD
American Academy of Family Physicians, Leawood, KS, statement.... 43
American Academy of Orthopaedic Surgeons, statement and
attachment..................................................... 45
American Academy of Pediatrics, statement and attachment......... 48
American Health Quality Association, David G. Schulke, statement
and attachment................................................. 54
American Society for Clinical Pathology, statement............... 57
American Society of Health-System Pharmacists, Bethesda, MD,
statement...................................................... 58
Cerner Corporation, Trace Devanny, Kansas City, MO, statement.... 62
College of American Pathologists, statement...................... 63
eHealth Initiative, statement.................................... 65
Healthcare Leadership Council, Mark R. Grealy, statement......... 68
Premier, Inc., statement and attachment.......................... 70
Siemens Medical Solutions Health Services Corporation, Malvern,
PA, Donald Rucker, M.D., statement and attachment.............. 71
HEALTH QUALITY AND MEDICAL ERRORS
----------
THURSDAY, MARCH 7, 2002
House of Representatives,
Committee on Ways and Means,
Subcommittee on Health,
Washington, DC.
The Subcommittee met, pursuant to notice, at 11:10 a.m., in
room 1100 Longworth House Office Building, Hon. Nancy L.
Johnson (Chairman of the Subcommittee) presiding.
[The advisory announcing the hearing follows:]
ADVISORY
FROM THE
COMMITTEE
ON WAYS
AND
MEANS
SUBCOMMITTEE ON HEALTH
CONTACT: (202) 225-3943
FOR IMMEDIATE RELEASE
February 27, 2002
No. HL-13
Johnson Announces Hearing on
Health Quality and Medical Errors
Congresswoman Nancy L. Johnson (R-CT), Chairman, Subcommittee on
Health of the Committee on Ways and Means, today announced that the
Subcommittee will hold a hearing on improving health quality. In
addition, strategies to ensure patient safety and reduce medical errors
will be discussed. The hearing will take place on Thursday, March 7,
2002, in the main Committee hearing room, 1100 Longworth House Office
Building, beginning at 11:00 a.m.
In view of the limited time available to hear witnesses, oral
testimony at this hearing will be from invited witnesses only.
Witnesses will include representatives from the U.S Department of
Veterans' Affairs, the provider community and academia. However, any
individual or organization not scheduled for an oral appearance may
submit a written statement for consideration by the Committee and for
inclusion in the printed record of the hearing.
BACKGROUND:
According to the Institute of Medicine (IOM), fatalities from
medical errors are estimated to be the eighth leading cause of death in
the United States. In 1999, IOM's study To Err is Human: Building a
Safer Health System, estimated annual deaths from medical errors are at
least 44,000 and may be as high as 98,000. The number who are injured
is higher.
More often than not medical errors occur because of endemic system
problems, not lack of skill or imprudence. Seniors interact with the
medical system more frequently than most because of the potential for
accident, injury or death to Medicare beneficiaries is more prevalent.
As the country's largest insurer of seniors, Medicare has the potential
to create processes and adopt technological advances that decrease
adverse medical events, thereby significantly improving the quality of
patient care and reducing Medicare costs.
In announcing the hearing, Chairman Johnson stated, ``Medicare
patients are some of the most vulnerable in the health care system. We
must take the opportunity presented by advances in patient care and
technology to protect seniors from harmful errors and improve the
quality of their care. There should be very little disagreement on such
a goal, so a bipartisan approach is possible. Here is an area where we
can revolutionize senior care.''
FOCUS OF THE HEARING:
Thursday's hearing will focus on improving health quality through
reductions in medical errors and enhanced patient safety.
DETAILS FOR SUBMISSION OF WRITTEN COMMENTS:
Please note: Due to the change in House mail policy, any person or
organization wishing to submit a written statement for the printed
record of the hearing should send it electronically to A
[email protected], along with a fax copy to
202/225-2610, by the close of business, Thursday, March 21, 2002. Those
filing written statements who wish to have their statements distributed
to the press and interested public at the hearing should deliver their
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Office Building, in an open and searchable package 48 hours before the
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1. Due to the change in House mail policy, all statements and any
accompanying exhibits for printing must be submitted electronically to
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2. Copies of whole documents submitted as exhibit material will not
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3. A witness appearing at a public hearing, or submitting a
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Note: All Committee advisories and news releases are available on
the World Wide Web at http://waysandmeans.house.gov/.
The Committee seeks to make its facilities accessible to persons
with disabilities. If you are in need of special accommodations, please
call (202) 225-1721 or (202) 226-3411 TTD/TTY in advance of the event
(four business days notice is requested). Questions with regard to
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Committee as noted above.
Chairman JOHNSON. Good morning, everyone. The hearing will
come to order, and while there are a number of other
Subcommittee hearings in progress, we are looking forward to a
lot of our Members joining us over the course of the hearing.
Unfortunately, medical errors are an endemic problem that
permeates our health system. According to the Institute of
Medicine (IOM), preventable medical errors are the eighth
leading cause of death in America, accounting for at least
44,000 and as many as 98,000 mortalities in hospitals each
year. The number of injured is even greater. In addition, IOM
also estimates that medical errors in hospitals cost between
$17 and $29 billion each year.
This is shocking and unacceptable to care givers and to
patients alike. As medicine has become more complex, systems
have not developed commensurate with the caregiving challenge.
Patients rely on the system to improve their lives, not
endanger them. And health professionals work long and hard
hours after years of intensive, costly training, to help
people, not to hurt them.
Not only do avoidable patient errors harm patients, they
drive up health costs by requiring expensive medical
interventions to correct subsequent problems. For example,
adverse drug events and interactions in hospitals are prevalent
and costly. According to estimates from Cardinal Health, Inc.,
there were more than 625,000 preventable adverse drug events in
hospitals in the year 2000, at a cost of $2.9 billion. Reducing
just half of those errors through innovations such as
electronic prescribing could save billions and patient lives.
I am hopeful that this Committee can produce bipartisan
legislation soon that will address this problem in a
thoughtful, effective way, honestly recognizing the lack of
malice that is causing such errors and the cost of the systems
necessary to address them. Systemic approaches to reduce
medical errors are endorsed by academicians and practitioners,
and have the potential to dramatically improve health quality
and patient safety while reducing costs.
The best way to reduce medical errors is to learn from our
mistakes, and I would like to just share a short passage from
the IOM study. One of the report's main conclusions is that the
majority of medical errors do not result from individual
recklessness or the actions of a particular group.
This is not a ``bad apple'' problem. More commonly, errors
are caused by faulty systems, processes, and conditions that
lead people to make mistakes or fail to prevent them. Thus,
mistakes can best be prevented by designing the health system
at all levels to make it safer, to make it harder for people do
so something wrong and easier for them to do things right.
Reporting adverse events allows us to gain insight into
those specific events and to identify patterns or common
factors creating errors, changing practices, and preventing
future errors. Individuals will not disclose their mistakes if
they think they are going to be embarrassed or harmed.
Appropriate legal and confidentiality protections are an
essential element of a reporting system that works.
One common cause of errors is illegible prescriptions,
because patients are often given the wrong prescription because
the doctor's handwriting is misread. Electronic prescribing has
the potential to dramatically improve patient compliance with
drug regimens, reduce adverse drug interactions, and improve
patient health and reduce costs.
Today we will hear from the Michigan Department of
Veterans' Affairs (VA). They have adopted a successful
reporting system that has improved patient safety. Also, the
Pittsburgh Regional Health Care Initiative will discuss their
success in implementing an ambitious zero tolerance policy for
medical errors, and I might add that we do have testimony from
Secretary O'Neill on this important system and issue, one that
he has been very involved in in the past. Finally, we will hear
from an academic and providers on their perspective to improve
health outcomes and patient safety.
I look forward to the testimony. The solutions to this
problem are not partisan. Working together, we have the
opportunity to literally save lives. I look forward to working
with my colleagues on the Committee to address this issue
promptly.
With that, I would like to recognize Mr. Stark.
[The opening statement of Chairman Johnson follows:]
Opening Statement of the Hon. Nancy L. Johnson, a Representative in
Congress from the State of Connecticut, and Chairman, Subcommittee on
Health
Unfortunately, medical errors are an endemic problem that permeates
our health system. According to the Institute of Medicine (IOM),
preventable medical errors are the eighth leading cause of death in
America, accounting for at least 44,000 and as many as 98,000
mortalities in hospitals each year. The number of injured is greater.
In addition, the IOM also estimated that medical errors in hospitals
cost between $17 and $29 billion each year. This is simply
unacceptable. Patients interact with the health system to improve their
lives, not endanger them.
Not only do avoidable patient errors harm patients, they drive up
health costs by requiring expensive medical interventions to correct
the subsequent medical problems. For example, adverse drug events and
interactions in hospitals are prevalent and costly. According to
estimates from Cardinal Health, Inc., there were more than 625,000
preventable adverse drug events in hospitals in 2000 at a cost of $2.9
billion. Reducing just half of those errors through innovations such as
electronic prescribing could save billions.
It is equally unfortunate that Congress has not taken significant
steps to address this problem. Many issues before this Committee are
contentious. This is an issue, however, that can and should be dealt
with in a nonpartisan manner this year. I am hopeful we can produce
legislation soon that will take care of this problem in a thoughtful,
collaborative way.
Systemic approaches to reduce medical errors are endorsed by
academics and practitioners, and have the potential to dramatically
improve health quality and patient safety while reducing costs.
One way to reduce medical errors is to learn from our mistakes.
Reporting adverse events allows us to gain insight into how to prevent
errors. But individuals will not disclose their mistakes if they are
punished for doing so. Appropriate legal and confidentiality
protections should be a part of any reporting system.
Often, patients are given the wrong prescription because of
illegible scripts from doctors. Electronic prescribing has the
potential to dramatically improve patient compliance with drug
regimens, reduce adverse drug interactions. For example, transcription
errors were eliminated and medication errors were cut in half after the
Ohio State University Health system implemented electronic prescribing.
As this Committee considers Medicare modernization and a prescription
drug benefit, it is critical that the Medicare program is equipped with
the necessary tools to ensure a reduction of medical errors and
improved health outcomes.
Today we will hear from the Department of Veterans' Affairs, who
has adopted a successful reporting system that has improved patient
safety. Also, the Pittsburgh Regional Healthcare Initiative will
discuss their success in implementing an ambitious zero tolerance
policy for medical errors. Finally, we will hear from an academic and
providers on their perspective to improve health outcomes and patient
safety. I look forward to your testimony.
I would like to once again stress that the solutions to this
problem are not partisan. Working together, Republicans and Democrats
have the opportunity to literally save lives. I look forward to working
with my colleagues to address this important issue.
Mr. STARK. Madam Chair, thank you, and I want to direct
this commentary not across the aisle but at the Congress in
general and certainly at the medical care delivery system in
particular.
Once again we are having a hearing. The IOM report came out
in 1999. We have had hearings. We had a similar hearing to this
identical hearing in 2000. Here we are, 2 years later, another
hearing. I have introduced a bill. I am not sure it is any
good, but there have been bills introduced to begin the process
of setting in place a system for systematically reviewing
medical errors and setting up procedures to prevent them.
Now, you are going to hear from some people that we should
have a voluntary industry effort. That is just crap. The Joint
Commission on Accreditation of Healthcare Organizations or
JCAHO isn't worth a pound of salt. They have never punished a
hospital that I know of in the existence of their so-called
inspections of the hospitals. They are paid by the hospital.
So, unless we are willing to sit down--we went through this
same thing with needle sticks. The hospitals fought us on safe
needles like Billy be-damned until some hospital got sued for
$8 or $9 million and then they said, ``Oh, maybe we should use
safe needles.'' They won't move unless we move and make it a
requirement.
Tort reform will come up. I think that is nonsense. If
somebody cuts off the wrong leg, you don't need a system to
tell you that you have been harmed, and you are going to sue.
If you are too dumb and don't know it is the wrong leg, maybe
you have got other problems.
I mean, there are tort suits in the medical system--it is
very dangerous going to the hospital, and it is one of the few
industries in this Nation that doesn't have a systematic,
detailed requirement for keeping records, for protecting
whistle-blowers, for doing all these things. It is going to
take a major mindset change that, if--in other words, you have
got to get over, ``You don't squeal on your buddies. That is
not considered nice in the delivery of medical care.''
Well, we have to make it very comfortable for people to do
that. As you say, confidentiality is important. There is a
whole host of things, but I just hope, Madam Chair, that you
will get a bill out. We ought to be able to get a bill like
this through on suspension if the hospitals don't fight us. All
right? I mean, who would think, if we came under suspension
with a bill that wanted to deal with quality of care, which is
not mentioned much in Medicare, that we would have any
resistance unless it comes from the very people who are
committing errors?
Now, it is not pointing a finger and saying it is because
they are not diligent. It is just, it is not required, and
until we require it, I think this is one of the areas that we
are going to have to say, I hope you will agree with me, that
we can't just talk it into conformity. We have to mandate it,
and that, I know it sounds like a regulation, but I hope we can
move to begin to do it and put it in law, and we will have
regular oversight perhaps.
So I thank you for getting the ball rolling, once again,
and I hope that the next meeting we have will be a markup.
Thank you.
Chairman JOHNSON. Thank you, Mr. Stark.
I do hope that this hearing will shed light on the two most
difficult issues in this area, and particularly the first issue
is what prevented legislative action following the hearing 2
years ago. There are two very difficult issues.
One is, how do you promote the kind of reporting that gives
you a handle on all the little, tiny things that happen, that
could have happened better? If you had known about them you
would have seen a pattern or you would have seen an opportunity
to put into place a system that would have prevented big
errors. And how do you differentiate the need for protection in
that system from the system that our malpractice laws serve? I
think those are two different systems, and the rules in my
estimation have to be different, but that is what we want you
to talk about. Do they have to be different, and how different?
The second issue that wasn't as big an issue 2 years ago
is, what is the cost of this? What do institutions have to be
able to fund, to manage, and to invest permanently in? Not just
the one-time cost. What are the ongoing, systemic costs of
changing the system of health care delivery to enable us to put
in place structural approaches that will minimize human error?
So those are the two issues. I hope we all approach this
hearing with an open mind on them, because last time our
inability to particularly resolve the issues around the
reporters did prevent legislation. I hope that won't be the
case this time, because there is simply too much opportunity
for us to not only protect patients but also to better serve
people who come out of medical training with enormous debts,
who are in this business to provide care for people who
desperately need it.
Mr. STARK. How about tying it to updates in the Medicare
reimbursement, Madam Chair? That might get some action.
Chairman JOHNSON. You and I have long disagreed on the
value of mechanical Federal formulas, and if what is happening
to physicians isn't evidence that mechanical formulas cause
problems, I don't know what is.
Okay, let's start. Dr. Bagian, Director of the National
Center of Patient Safety, the Michigan Department of Veterans'
Affairs, from Ann Arbor. Thank you for being with us and for
sharing your experience in these areas.
STATEMENT OF JAMES P. BAGIAN, M.D., P.E., DIRECTOR, NATIONAL
CENTER FOR PATIENT SAFETY, VETERANS HEALTH ADMINISTRATION,
MICHIGAN DEPARTMENT OF VETERANS' AFFAIRS, ANN ARBOR, MICHIGAN
Dr. BAGIAN. Thank you, Madam Chairwoman, for the
opportunity to come here, and Members of the Committee. I
thought I would share the experience of a little bit of the
Michigan VA and try to answer some of the questions you just
posed in the initial remarks here.
We certainly agree that safety is the foundation upon which
quality is built. You can't begin to say you have a quality
system if you don't provide safety to the patients. The
Michigan VA has been very interested and active in patient
safety since 1997, almost 2\1/2\ years before the IOM report
you mentioned in your initial comments. We have worked very
hard on that, and I will share some of those lessons.
My history is slightly different. I began as an engineer,
became an astronaut, and spent much time in aviation as well as
medicine, and then came to this, which I felt was a very good
chance to bring systems thinking and prevention to medicine,
which we hadn't always done in very systematic ways. I think
there are several points we need to recognize here.
Though often people in shorthand talk about errors, medical
errors, and in fact if you look at the patient safety handbook
in the Michigan VA, we don't use the term ``errors'' at all. It
doesn't appear, because errors are just one subset of things
you want to prevent. There are many things that occur that
people would not view as an error but yet cause harm to the
patient, and it is harm to the patient we want to prevent.
They are human beings. Whenever there are human beings in
play, there will be errors made. No one is perfect. If we
require them to be perfect in order not to harm a patient, that
is a losing bet, guaranteed.
In aviation, for example, you have more than one engine on
a plane that flies across the ocean. The reason is not that we
try to build engines that are unreliable, but we recognize one
might fail and yet we don't want the plane to crash. In
medicine, on the other hand, we have single-engine planes, and
we figure they have got to be perfect, and we know they always
aren't. So we think we need to look at that.
We have to understand that it is systems solutions. As you
pointed out, people don't come to work to hurt a patient. That
is not the issue. The issue is when people that are well-
meaning make mistakes or don't use things appropriately. There
is a whole number of things. It is not just errors.
How do we figure out how to prevent those things and put
systems in place to really study the causes? It is not so
simple as the typical line that you hear, for instance, on a
medication problem: ``Tell the nurse to be more careful.'' That
is not really a Nobel Prize winning strategy. We have to wonder
why did this happen.
I think we need to understand that the systems, there are a
number of accountability systems that have been in place and
still are, and they are appropriate. There is appropriate use
of the accountability systems, but you need a learning system,
one by which we can learn when there is a problem. We share it
very quickly with others, so they can learn. If we don't do
that, we cause everyone to pay the same price for their own
individual learning, and they don't share, so each one of us
learns from the injury of a patient. That is a terrible way to
do this.
You talked about cost. I can tell you in the Michigan VA we
have looked at this as we put the system in place which is in
place in all our facilities. We see the cost in aggregate, in
full time equivalents (FTE), if you want to look at it that
way, is about 1.1 FTE a year to do full root cause analysis and
corrective actions in a large-size hospital.
That is peanuts. That is really nothing when you look--and
I can show you a number of examples, I won't waste the short
time I have here right now--but just small corrections often
cause avoidable, just in costs, operating costs alone, often
$100,000 a year, which more than pay for the cost of that. So
to say it is a cost, it really isn't. It is a cost avoidance
strategy, but you have to pay some money to make some money.
It is not blame and shame. It is you really want to learn
from these things and set up a way to do it, and that is
understanding what is blameworthy and what is not. We don't say
our system is a blame-free system. Please understand what I
mean by this.
What we did is, we say there are some actions that are
blameworthy, that is what we call intentionally unsafe acts,
those acts that are criminal acts, acts that involve substance
or alcohol abuse on the part of the care provider, or acts that
were intentionally unsafe. That is, the person knew it was
unsafe and did it anyway.
I think we all would agree they should be in a system that
is discoverable, that is available to a plaintiff's attorney or
anybody else who wants to look at it. On the other hand,
innocent mistakes, if you will, do not deserve that same
treatment. They should be confidential so people can feel free
to share them locally and globally so people can learn, and we
have that ability within the Michigan VA system. We think that
is important.
Since we put this system in place, we have seen a 30-fold
increase in reports, we have seen a 900-fold increase in close
call reporting, 900-fold. That is 90,000 percent, which means
close calls are those bad things that could have happened but
didn't. You want to learn by those. You don't want to wait
until somebody is hurt before we decide to do something
different. Learn from the close call. We do that, and I have
numerous examples where concrete things that had global impact
have been detected through that.
We also found in the old systems, 50 percent of the cases
that would be looked at, people thought were not preventable
because we didn't give them good systems tools to look at this,
good human factors oriented tools. Now 100 percent come back
with prevention, preventive strategies. That is huge. That
means people are thinking differently. We think that is
important.
To get there, though, we had to deal with certain barriers,
and the barriers were, people were worried about punitive
action, and that is from their perspective, not from the boss's
perspective. That is not just, are you going to get fired, are
you going to be suspended? That is are you going to be publicly
humiliated, embarrassed?
All those things count. They are real roadblocks to
sharing. We have to have protection so people understand that
when they are not in the blameworthy category, that they can
share, because the blameworthy ones won't tell you anyway. You
know, if people did it deliberately, they are never going to
tell you, so you have to have your other accountability
mechanisms to deal with that.
Aviation learned this a long time ago with the Aviation
Safety Reporting System (ASRS), because aviation had this
problem. There was a crash not 40 miles from where we are
sitting right now, where 92 souls perished, all because what
was learned 6 weeks prior to that by another crew wasn't shared
because of fear of punitive action. The Federal Aviation
Administration, FAA, reacted decisively, started, had National
Aeronautics and Space Administration (NASA) start the ASRS, and
now they have a de-identified, that is not anonymous, reporting
to NASA, which then shares those vulnerabilities with the
community so they can be addressed.
We have an internal system at the Michigan VA, but we also
have an external system we have set up that NASA actually runs
for us, and it allows people to report. Now, I will say that
that is something that can be used anywhere. We cannot right
now, because of confidentiality issues, open it to outside
Members, but Kaiser Permanente for instance has approached us
and wants to be part of it. The U.S. Department of Defense,
DOD, does. University of Michigan does, Vanderbilt, and on and
on and on.
Until there is legislation which allows people to be able
to share these things between institutions within a State, and
more importantly, across States, they can't do that, because to
share that means it is all discoverable, which means people
will not report. So in the safety realm we need protection if
you want people to truly be able to share nationally. The
Patient Safety Reporting System, PSRS, that has already been
put in place with NASA, what we have done, could easily be
opened up to others with the stroke of a pen, but without
confidentiality protection it cannot happen. So we think this
is extremely important and necessary and would really put it
forward so people can share and learn.
I guess I would leave you with, until now the way we have
worked in medicine is experience is the best teacher, but it is
also the most costly teacher, and the people who pay our
tuition are the patients. That is a terrible way to do
business. We should really learn from each others' experience
and not cause us to learn through harm done to others. Thank
you.
[The prepared statement of Dr. Bagian follows:]
Statement of James P. Bagian, M.D., P.E., Director, National Center for
Patient Safety, Veterans Health Administration, Michigan Department of
Veterans' Affairs, Ann Arbor, Michigan
Mr. Chairman and Members of the Committee, I am pleased to be here
today to discuss the significant challenge of improving the safety of
health care delivery and particularly the approach that VA is taking to
address this problem.
Inadequate patient safety is a critical worldwide problem in
healthcare. In the U.S., estimates of the lives lost due to factors
related to patient safety exceed that of the lives lost due to motor
vehicle accidents, breast cancer, or AIDS (IOM, To Err is Human). In
order to reduce medical errors, programs must first identify the
underlying causative factors so that they can be understood, and then
implement effective preventive strategies. Unfortunately, most
healthcare systems and regulators have not modified their tactics to
focus on prevention. The systematic problems that are associated with
medical errors and close calls persist; namely the belief that
accountability systems and punishment are the primary and most
effective means to achieve improvement in patient safety. While
accountability systems play an important role in health care
organizations, they cannot do all things. Albert Einstein once
observed, ``Insanity: doing the same thing over and over again and
expecting different results.'' This is where we seem to currently find
many individuals and organizations in their quest for patient safety
improvement. Put another way--the health care system punishes providers
without giving them the tools to improve patient safety.
An over-reliance on punitive accountability systems is a major
stumbling block to improvement because it does not encourage
identification of potential problems and provides disincentives for
reporting. This state of events is not peculiar to healthcare and has
been encountered by other industries. Aviation recognized that further
improvement in safety could not be achieved by putting in place yet
another accountability system. Instead they introduced a system whose
purpose was learning, whose goal was prevention not punishment, and
most importantly was viewed as both beneficial and non-punitive by the
end-users or those from whom reports are sought. Today in medicine
there is no dearth of accountability systems but there is a scarcity of
systems that are viewed as non-punitive reporting systems.
To address these needs the VA developed and continues to implement
an innovative systems approach to prevent harm to patients within VA's
163 medical centers. VA recognized that individual human behavior is
seldom the basic reason for medical adverse events--adverse events are
usually due to the complex interaction of known and unforeseen
vulnerabilities in health care delivery. Innovations were necessary,
since no one had ever instituted a comprehensive systems-oriented
safety program for large medical organizations. VA combined lessons
from industrial settings such as aviation and nuclear power with the
theory and body of knowledge from human factors and safety engineering
to fashion systems that would better contribute to prevention of
unintended harm to patients. (Human factors engineering was cited by
the 1999 IOM report as the discipline most often overlooked by health
care when designing safety systems.)
VA implemented nationwide internal and external reporting systems
that supplement the many accountability systems we already had. The new
systems' sole purpose was for organizational learning. They were
constructed to encourage maximal reporting of even close calls and
potential problems with non-punitive methods. This was essential
because without the ability to identify system vulnerabilities and to
analyze their root causes for common systematic problems our ability to
achieve meaningful and sustainable patient safety improvement is
limited. One method VA employed to better understand how to make these
systems optimally function was to first do some surveys and focus
groups of both VA and external healthcare workers to better understand
their concerns and the characteristics that would help make our program
effective. One point that was clear concerned the issue of punitive
measures. Specifically, health care providers' view of punitive actions
extended beyond typical administrative punishment to include factors
such as shame, embarrassment, and professional reputation. Protection
from these factors, was essential if we were to receive any reports
from which we could then learn and proceed to undertake improvement and
prevention efforts. This information convincingly demonstrated that
confidentiality is pivotal to assuring the non-punitive intent and
potential of your learning system to the personnel from which you wish
to receive reports.
The importance of confidentiality has been shown in many safety
systems ranging from military aviation safety programs to the NASA--
Aviation Safety Reporting System (ASRS). The ASRS program and its
success have been cited in numerous venues including the IOM Report `To
Err Is Human.' For more than 25 years, the ASRS has handled over
500,000 reports without compromising the confidentiality of its
reporters. Maintaining this level of trust has been essential to
allowing the ASRS to identify problems and systems vulnerabilities that
were subsequently dealt with, which otherwise might have resulted in
catastrophic events. There are also examples of other aviation safety
systems patterned after the ASRS, such as the one in New Zealand, that
were initially successful until they divulged the identity of a user
resulting in the cessation of reporting and effectively the end of
their system. In fact, after the passage of several years they tried to
re-establish their system but failed to do so due to their inability to
ensure that confidentiality would be maintained. This experience
demonstrates that once trust is violated it can be extremely difficult
or impossible to restore. Ultimately, public safety suffers because
problems cannot be identified early and corrected.
Confidentiality is the common element that enables a safety system
to be effective. It is important to recognize that making patient
safety information confidential does not deprive any of the pre-
existing internal or external accountability systems of information
that they require. The two systems are mutually independent, that is,
data reported and developed in the course of a patient safety activity
is in addition to, separate, and apart from events identified to
oversight reports. Voluntary reports on close calls and other problems
would not otherwise exist were it not for a confidential system.
Currently, the statutory protection for this type of information varies
from state to state and does not permit the confidential and privileged
sharing of information across state borders. Confidentiality for
patient safety information, if uniformly available, will facilitate the
sharing of information between institutions in a particular locale as
well as on a national basis. Without it, the fear of shame,
embarrassment, and other punitive measures stands in the way of
dissemination of information that will improve the quality and safety
of health care and benefit patients everywhere.
Experience in the VA system has shown that reporting of events and
especially close calls increased dramatically after clear definitions
were enacted as to what constituted a confidential patient safety
issue. This has resulted in the identification and mitigation of system
vulnerabilities not just within the VA system but globally. Without
confidentiality the same results could not have been achieved.
Interest in improving patient safety is at an all time high. Very
early, VA identified improved patient safety as a high priority. Our
systems now serve as benchmarks to be emulated by others. We are proud
of our accomplishments, however, there are numerous other methods and
approaches that are currently in use, being developed, or are being
contemplated. As more experience and data emerge from these activities
it will be possible to identify safe practices that can be universally
applied for patients' benefit. Uniform, unambiguous, and assured
confidentiality of patient safety information is essential for these
efforts to flourish. We must approach patient safety in a way that
emphasizes and celebrates prevention, not punishment.
Thank you for the opportunity to appear before the committee. I
will be pleased to respond to your questions.
``The significant problems we face cannot be solved at the
same level of thinking we were at when we created them.''
Albert Einstein
Chairman JOHNSON. Thanks very much, Dr. Bagian. We will be
working closely with you as we use your experience, amongst
others, to help guide us in making these difficult decisions. I
thought the difference you drew between accountability and
learning systems is really key here.
I am going to go slightly out of order for a variety of
reasons. I would like to recognize Dr. Miller from Danbury
Hospital. First of all, his testimony will put in perspective
the other half of this problem at the very beginning of the
hearing, and second, I am very proud of his leadership, as I am
of the Connecticut hospital system, and have worked very
closely with the hospitals in my district because I have
hospitals that are very small in rural areas, and hospitals
that are superb teaching hospitals. Dr. Miller runs the Danbury
Hospital, which is kind of a hybrid of both. It is a teaching
hospital in a small city, surrounded by relatively small towns
but on the border with New York and in the New York City
environment.
So it is a pleasure to have you with us, Dr. Miller, and to
have you share the experience of an institution in trying to
grapple with these very problems.
STATEMENT OF MATTHEW MILLER, M.D., VICE PRESIDENT, MEDICAL
AFFAIRS, DANBURY HOSPITAL, DANBURY, CONNECTICUT, ON BEHALF OF
THE AMERICAN HOSPITAL ASSOCIATION
Dr. MILLER. Madam Chairman, I am the Vice President of
Medical Affairs----
Chairman JOHNSON. You have to get very close to these
microphones.
Dr. MILLER. I am the Vice President for Medical Affairs at
Danbury Hospital, a community teaching hospital in Danbury,
Connecticut. I have worked in health care for 30 years as a
practicing physician, and for the last 10 years as a physician
executive. I am here today on behalf of the American Hospital
Association (AHA). We appreciate the opportunity to present our
views on improving health care quality and safety.
We are extremely proud of the initiatives that hospitals
and their staffs have adopted to improve patient safety. We are
eager to work in furthering those efforts. I would like to talk
about the importance of creating a culture of safety in health
care, the role of medical error reporting, and the potential of
technology to prevent adverse events.
We must create a system where medical errors are detected
and analyzed so that we may learn how to reduce those errors in
the future. To do this we must, one, provide a nonpunitive
environment for reporting errors; recognize that most errors
are failures of systems, not individuals; investigate errors
thoroughly, using root cause analyses; and, four, collaborate
with experts and peers on the lessons learned.
The AHA supports efforts underway in the Senate to create
an improved confidential system for the voluntary reporting of
patient safety information. We hope that this Subcommittee will
take a similar approach.
We all agree that reducing medication errors is a critical
goal for us improve health care safety. We must have systems in
place to ensure that important clinical information is
available to physicians at the time drugs are prescribed, so
that orders can be complete and accurate. Effective medication
management systems must ensure that the right patient is
getting the right medication at the right time, the right dose.
New technology can be very helpful in reducing medication
errors. Examples include computerized physician order entry,
CPOE, and bar coding for drug and patient identification. We
need to recognize, however, that these technologies do not
provide a single silver bullet solution to these medication
errors.
With CPOE, physician orders are entered directly into a
computer. The computer provides real time patient data,
including allergies and lab test results. It also provides
pertinent formulary information, standard dosing protocols, and
guidelines for care, all in one location. I do believe that
CPOE systems, when fully implemented, have extraordinary
potential to prevent errors.
We have begun implementing CPOE at Danbury Hospital, but
the road will be long and arduous. We cannot discount a number
of other very important considerations.
One, CPOE is expensive. We will need at least $2.5 million
over the next 2 years, and we are getting off cheap because we
had already purchased a system. Other comparably sized
hospitals to mine will spend $5 to $10 million, and that
doesn't include maintenance.
The CPOE is fairly new, not widely tested beyond large
academic medical centers with homegrown systems.
Three, there is no off-the-shelf package ready to install.
The CPOE requires substantial customization.
Four, CPOE systems must interface with other hospital
information systems. We, for example, just discovered a problem
with our pharmacy system. We will have to change that system
entirely.
Five, staff support for implementation will be huge,
involving physicians, pharmacy, nursing, information
technology. Not all hospitals have those resources either for
implementation or for maintenance, and ultimately, education of
all the staff and major work redesign will be necessary to
achieve all the planned goals.
We can't forget that there are multiple other medication
management strategies that hospitals can and, in fact, must
implement first, such as standardized orders, practice
guidelines, formulary control, computerized access to clinical
information. These strategies can accomplish a lot and they are
actually much easier to implement.
Bar code technology is another tool to prevent medication
errors. The AHA is very supportive of efforts underway at the
Food and Drug Administration or FDA to promulgate bar code
regulation that will enable information systems to verify
correct patient medication and dose.
It is important to understand this issue against a backdrop
of larger health care environment. Hospitals are facing
unprecedented pressures, including a severe work force
shortage, soaring pharmaceutical prices, and increased
professional liability costs.
In conclusion, a third of all hospitals are operating in
the red today and another third are teetering on the edge. It
is vital that hospitals have adequate resources to meet the
needs of their communities, and for this reason we are asking
Congress to forego budget neutral provider payment adjustments;
approve the full Medicare inpatient inflation update; protect
Indirect Medical Education or IME payments; and help find a
solution for the nearly 40 million uninsured. We look forward
to working with Congress and others to help us cross what has
been called a quality chasm.
I would be happy to answer any questions.
[The prepared statement of Dr. Miller follows:]
Statement of Matthew Miller, M.D., Vice President, Medical Affairs,
Danbury Hospital, Danbury, Connecticut, on behalf of the American
Hospital Association
Madame Chairman, I am Matthew Miller, M.D., Vice President for
Medical Affairs at Danbury Hospital in Danbury, Connecticut. I am here
today on behalf of the American Hospital Association's (AHA) nearly
5,000 hospital, health system, network, and other health care provider
members. We are pleased to have the opportunity to testify today on an
issue of critical importance for hospitals and the patients and
communities they serve: improving health quality by developing
strategies to ensure patient safety and reduce medical errors.
Danbury Hospital is the primary diagnostic and treatment center for
approximately 361,000 residents in western Connecticut and adjacent
counties in New York State. We are a major teaching facility with a
highly skilled staff and state-of-the-art technological capabilities,
which include: a Level II trauma center; magnetic resonance imaging
(MRI); laser, laparoscopic, and endovascular surgery; two linear
accelerators; interventional radiology; a neonatal Level II nursery;
and a state-of-the-art cancer center. The hospital is recognized as a
regional referral center and as the community health center for Danbury
and the surrounding areas.
I have spent most of my 30-year career in health care as a
practicing pulmonologist and physician executive. As Vice President for
Medical Affairs I have administrative responsibility for clinical
quality and safety, utilization of clinical resources, risk management,
medical staff credentialing, regulatory compliance, and medical staff
liaison functions. It is with this experience that I come before you
today to discuss medical errors, how technology can help reduce those
errors, and the role that hospitals play in improving patient safety
through these initiatives.
Madame Chairman, I would like to state, on behalf of the entire
hospital community, how proud we are of the initiatives that hospitals
and our staffs have already adopted to improve patient safety. We look
forward to working with you in the future as we continue to enhance our
safety policies so that we minimize errors and continuously improve our
care. This hearing gives all of us testifying before you today an
opportunity to share our insights with you, and with each other, so
that together we can reduce medical errors. As I'm sure my colleagues
will agree, improving health quality and patient care is a team effort
and we stand ready to do our part.
CREATING A CULTURE OF SAFETY
Hundreds of times a day, every day in today's hospitals, health
care is provided through a complex system that involves people,
technology, medical devices, and pharmaceuticals. This complexity has
mushroomed in the past decade. Preventing and reducing errors is
therefore a very complicated task that never ceases. Every medical
error, whether or not it causes harm to a patient, must be detected and
analyzed systematically in order to improve our ability to prevent
these errors.
To prevent errors, we must create a culture of safety. Most of what
has been learned in recent years about how to reduce errors and improve
patient safety is based on two guiding principles. First, human beings,
by their very nature, are vulnerable to error. Although the individuals
involved are sometimes the focus after an error occurs, we know that
errors most often occur because of failures in the systems in which
individuals work. As a result, reducing medical errors will require us
to develop and re-design the delivery of health care to build in error-
resistant systems.
Second, we must create an environment in which we learn from our
mistakes. As a first step, we have to develop effective mechanisms for
candid discussion of errors, something that cannot be achieved in an
environment of punishment or fear. Physicians, nurses, and other
caregivers should not be penalized for stepping forward after a mistake
has been made to report their error or an error they observed. We need
to create supportive systems both within health care organizations and
through specific legal reforms.
Today, when health care providers share confidential internal
information with health care oversight agencies, other hospitals, or
outside experts, they may jeopardize the protection that state laws
provide to internal quality analysis discussions and expose the
institution and caregivers to crushing legal liabilities. This legal
``Catch 22'' impedes efforts to share critical safety and quality
information and analysis to prevent similar events from happening. It
is essential that carefully constructed federal confidentiality and
evidentiary legal protections be developed to encourage a culture of
safety based on candor and learning. Further, reporting must be
standardized and carefully defined.
The AHA continues to support federal legislation to address this
issue. In the Senate, there is an effort underway to address how the
Congress could create an improved system for the voluntary sharing of
patient safety information both with external experts and across health
care delivery sites with adequate confidentiality protections. We hope
that this subcommittee will consider a similar approach in addressing
health care safety issues. It is vital that the Congress enact
legislation that protects the analysis and sharing of adverse event and
other patient safety information so that caregivers can uncover,
analyze, and share their experiences and learning, without fear of
reprisal.
At Danbury Hospital, we are committed to creating a culture of
safety. We have put in place a non-punitive reporting system that
relies on intensive safety, education, and quality training. We
scrutinize any adverse event to understand the cause so that we can
change our systems to prevent similar occurrences. Further, we are
committed to using new technologies that will improve patient care.
THE POTENTIAL OF NEW TECHNOLOGIES
Medication errors are a critical concern for health care. We know
from the research that roughly two-thirds of medication errors, those
that reach or don't reach the patient, occur in physician ordering and
administration.\1\ We must have systems in place to make sure that
important clinical information is available to physicians and
pharmacists at the time drugs are prescribed. Further, we must build
systems that make sure the right patient is getting the right
medication and dose at the right time.
---------------------------------------------------------------------------
\1\ Leape LL, Bates DW, Cullen DJ et all. Systems Analysis of
Adverse Drug Events. JAMA 1995; 274:35-43.
---------------------------------------------------------------------------
There is extraordinary promise in reducing medication errors by
using technology such as Computerized Physician Order Entry Systems
(CPOE), bar-code technology, and drug administration systems, and
through the development of standardized electronic medical records.
However, there are very important issues surrounding their availability
and implementation. Allow me to focus on CPOE and bar-coding as
examples.
One way patient safety can be improved by information technology is
through the use of machine-readable symbols such as bar-codes in a
standardized format on all quantities of medication matching the right
drug to a patient bar-coded identification. Bar-code technology can
enhance patient safety by ensuring there is real-time verification of
the correct patient, medication, dose, and time. The AHA is very
supportive of efforts underway at the Food and Drug Administration
(FDA) to promulgate regulations that would require human drug products
and biologics to be bar-coded. This effort will promote code
standardization, which will successfully enable information systems
that rely on the availability of bar-coded drug information.
In the area of medication ordering, CPOE systems have great
potential to reduce prescription-based errors. As you know, CPOE is a
computerized system that allows physician orders to be entered directly
into a computer, which simultaneously provides vital patient data and
guidelines that give the physician valuable information as these orders
are entered. CPOE centralizes critical information, such as: the
patient's vulnerability to allergies, interaction with other drugs,
standard dosing, recent pertinent laboratory data, prescribing tips,
and standard or customized order sets.
At Danbury Hospital, I have spent considerable time carefully
examining CPOE systems and, while I firmly believe that CPOE can reduce
errors, reduce unnecessary variations in care, and improve staff
efficiency, it is important to also recognize that these systems do not
provide a single, ``silver bullet'' solution to drug prescribing
errors. We are committed to implementing CPOE over the next two to
three years, but it will be an expensive and arduous road. Let me share
with you what I have learned about these systems.
The science of CPOE is still very new, except for the handful of
larger academic institutions with home-grown systems developed over
many years. While about a dozen commercial systems are available today,
many of these systems have not been tested widely and have not been
tested in what would be considered a prototypical community hospital.
Although most of these health care organizations report significant
quality and safety gains, in many instances, the cost savings are
elusive, or at least difficult to quantify. Further, CPOE systems are
not standardized--there is no off-the-shelf system that can be
purchased tomorrow and operated immediately. It is important that the
vendor community speed-up its efforts to create standardized systems
that can be readily adopted so that hospitals can be assured that their
investment will result in the care improvements anticipated. This is
also an area where there may be a role for federal research through the
Agency for Healthcare Research and Quality.
It is essential that CPOE systems effectively interface with other
information systems in use at the hospital. Specifically, it is
critical that these systems work with the pharmacy, laboratory,
radiology, and medication administration systems already in place. At
Danbury Hospital, we have identified a problem with the interface
between our CPOE vendor's system and our current pharmacy computer
system. As a result, we will have to completely replace the pharmacy
system at an additional cost of $500,000, adding six to nine months to
our implementation plan.
In addition, the cost to implement such systems can be
overwhelming. For Danbury Hospital alone, we estimate putting in a CPOE
system will cost $2.5 million over the next two-and-a-half years, a
relatively low estimate because we have already purchased the software.
Nor does this figure take into consideration annual maintenance costs
of about $500,000. For other comparable hospitals starting from
scratch, the literature estimates a cost from $5 to $10 million to
fully implement an effective CPOE system
Hospitals face many challenges when it comes to implementing a CPOE
system. This is a massive undertaking, which for Danbury Hospital will
require a significant amount of clinical and technical manpower over
the next two years to successfully achieve our objective. It is
critical to the success of a CPOE system to have the commitment and
active involvement of pharmacy, nursing, and medical staff. Without the
buy-in and participation of physicians and others, CPOE systems will
remain unused or misused, and potentially create new sources of error.
This commitment means many hours of planning by key personnel, as well
as massive education for the entire hospital staff.
In order to realize all of the goals of CPOE, be they reduced
costs, improved quality, or most particularly improved safety,
hospitals will need to redesign the work processes of their physicians,
nurses, pharmacists, and technicians. Short of embarking on CPOE, there
are multiple other medication management strategies that hospitals can,
and must, implement first, such as standardized orders, practice
guidelines, formulary control, and computerized access to clinical
information. These strategies begin the consensus building process.
Suffice it to say that although we are committed to CPOE, it has been a
tough decision to proceed, carefully weighed, and one that will occupy
a great deal of our time and resources over the next two years.
Hospitals must also ``own'' and manage the system, which requires
hands-on, expert information technology (IT) staff. But it is important
to understand the reality of hospitals' financial situation. Many
smaller hospitals simply can't afford to make the large financial
commitment that maintaining such a level of IT staff support. For
hospitals that may have the available IT resources, many are currently
over-taxed attempting to meet the obligations and deadlines set forth
in the Health Insurance Portability and Accountability Act (HIPAA).
CPOE is just one example of a promising technology where
stakeholders need to work together before widespread implementation is
a reality. But in many cases, successful implementation of new
technologies will require further scientific advancement of the
technology, worker buy-in, and capital to purchase needed technologies.
Hospitals are committed to using the best available technology within
their resources to improve patient care and reduce medical errors.
Overcoming these obstacles will be critical to realizing the
substantial benefits CPOE has to offer hospitals and the health
delivery system as a whole. We look forward to working with the
Congress, the vendor community, and others to address these issues so
that we may truly improve patient safety and save lives.
OTHER HOSPITAL CONSTRAINTS
While I know that the focus of today's hearing is on how to improve
patient care and safety, it is important to understand this issue
against the backdrop of the larger health care context. As this
subcommittee is well aware, hospitals are facing unprecedented
pressures that, when put together, threaten to erode the community
hospital's foundation. Let me just touch on a few.
There is an alarming health care workforce shortage nationwide,
with 168,000 open positions in hospitals alone. Critical shortages in
nursing and pharmacy positions hurt hospitals' ability to successfully
adopt new technologies, such as CPOE systems, which rely on the
availability and expertise of pharmacy staff in particular.
Hospitals are also facing soaring pharmaceutical prices, with
annual double-digit increases in cost. Further, changes taking place in
the legal system mean that hospitals and caregivers face considerable
increases in professional liability coverage costs. And, as you know,
we are working to provide new equipment and training so that our
hospitals will be prepared for any emergency, including the threat of
bioterrorism.
In Connecticut last year, only a minority of hospitals had a
positive operating margin. Throughout the United States, one-third of
all hospitals are operating in the red and another third are teetering
on the edge financially. It is vital that hospitals have adequate
resources to meet the needs of their communities. This means not
allowing ``budget-neutral'' spending decisions to further reduce
Medicare and Medicaid payments to hospitals. And it means making
improvements, such as the full Medicare inpatient inflation update,
which will help us continue to meet the soaring demands being placed on
us.
Further, teaching hospitals, such as Danbury, are facing a
significant cut in our graduate medical education funds. This scheduled
cut must be eliminated if we are to continue providing sufficient
resources to train the next generation of caregivers in the practices,
and use of potential technologies, that can improve patient quality and
safety for years to come.
Finally, there are nearly 40 million people living in the United
States who do not have health insurance at all. Medical studies
demonstrate that the uninsured live sicker and die younger because they
are forced to go without the medical help they need. The men and women
of America's hospitals see every day the devastation and pain that are
caused when people do not have coverage, causing them to come to us
much sicker than they should.
CLOSING
For thousands of years, healers have lived by the motto ``primum
non nocere''--first do no harm. The nurses, doctors, and others on the
hospital patient care team strive every day to deliver safe, efficient,
and compassionate care. But in today's complex, high-tech world of
medicine, despite our best efforts, we can have unwanted and unintended
consequences. As good as our systems are for preventing and reducing
medical errors of all kinds, we can and must do better.
It is important that we continue to focus on what it means to
promote a culture of safety. At AHA, and at Danbury Hospital, we are
committed to these important issues.
You have heard testimony about creating a culture of safety at the
Veterans' Administration (VA) and received a statement regarding the
airline safety reporting system run by the National Aeronautic and
Space Administration (NASA). There is much to learn from their
successes in promoting a culture of safety, in particular through the
creation of non-punitive systems for the reporting and sharing of
adverse event information.
In our efforts to create a culture of safety, there is a role for
technology, and in particular CPOE systems, to help prevent medical
errors and improve care. But we must be cognizant of technological,
cultural, financial, and other challenges as we strive to provide the
best possible health care to every patient that comes through our
doors. Again, it is important to remember that there is not one
solution or one activity that will make our systems error proof.
We look forward to working with Congress, our colleagues, and the
vendor community to address head-on the financial, technological,
legal, and cultural issues that can help us cross what has been called
a ``quality chasm.''
Chairman JOHNSON. Thank you very much, Dr. Miller.
I would like to recognize Dr. Berwick, the President and
Chief Executive Officer (CEO) of the Institute for Health Care
Improvements in Boston. Dr. Berwick.
STATEMENT OF DONALD M. BERWICK, M.D., PRESIDENT AND CHIEF
EXECUTIVE OFFICER, INSTITUTE FOR HEALTHCARE IMPROVEMENT,
BOSTON, MASSACHUSETTS
Dr. BERWICK. Thank you, Madam Chair. I have submitted my
full remarks for the record.
Since the IOM report, there has been indeed a lot of
progress in this country, and I want to acknowledge that. The
issue is explicit and visible. Most consumers seem aware that
there are safety challenges in the health care system. A lot of
hospitals have begun to promise to improve safety, and a small
but important minority of them are becoming much more open
about their own injury rates and measuring their frequency.
Some of the highlights include the work at Pittsburgh you
will be hearing about. I am aware of community efforts in
Whatcom County, Washington and in Florence, South Carolina, to
improve safety at the community level. There is a consortium of
children's hospitals that is focused on this as their primary
agenda. I am aware of a collective of 57 hospitals working on
substantial safety improvements, and other important progress
is being made nationally.
The Federal leadership on this has been dramatically
important. The work at the VA, DOD, the Health Resources and
Services Administration (HRSA), and most importantly, the
Agency for Healthcare Research and Quality (AHRQ) has actually
been, I think, the catalytic work in this country. I want to
personally thank Congress on behalf of my colleagues for your
commitment and bipartisan support for this work, but there are
obstacles. We are not going fast enough. Let me tell you what
some of the obstacles are.
First, there is still denial in the industry. There are a
lot of doctors and hospitals that still think this isn't a
problem. We need congressional voice, Federal leadership to say
it is a problem and it must change.
The second obstacle is capital costs. Some of the
technologies to get safety systems into place are beyond the
reach of small hospitals especially. There is a threshold to
cross here. Last week the Advisory Board published a report
saying that CPOE, which I thoroughly endorse, costs something
like $7.5 million per facility.
We know CPOE, for example, saves money. There is a good
study in JAMA, the Journal of the American Medical Association,
that said there is a 13-percent reduction in the total cost of
hospitalization in hospitals with CPOE introduced, 13 percent
on the bottom line of costs. I believe it is there, but it is
downstream, and we have got to get over this activation issue.
The third problem is, we are still paying for defects. I
don't think hospitals intend to hurt anyone, but it still is
true that hospitals that injure patients get paid for treating
those injuries.
Fourth, there is lack of standardization. I will come back
to that in a minute. The Federal government has a real
opportunity to offer some standardization that would help the
industry accelerate.
Finally, there is persistent fear. For a lot of reasons--
lawsuits, embarrassment, loss of market share--organizations,
individuals in health care are very frightened to discover and
reveal and discuss openly their defects. We have got to get
over this. Fear is incompatible with learning, and safety can't
be achieved without learning. Safe systems are open,
transparent systems. A frightened work force is not going to go
there.
We have been distracted by the issue of public reporting. I
have an opinion on this. I think we need to be committed to
transparency, but we have a very frightened work force that
needs some security to know that they can discuss safety issues
safely, or we are not going to get further on this.
I think we have been stuck in a national debate about
mandated reporting or not mandated reporting. I think we have
to get over it. What we know is, safety has to be openly
discussed, openly assessed, openly explored. The Centers for
Medicare and Medicaid Services (CMS) should insist that health
care organizations that it pays have to assess safety, they
have to study it, they have to discuss it openly, they have to
learn about their own injuries. That is for sure.
I have six suggestions for Congress about things you could
do that would help us at this stage. It is not primarily a
Federal problem, but let me tell you what I think would help.
First, please continue to support the investments that you
are seeing in the VA, in HRSA, in DOD, and in AHRQ in this
agenda. We are really getting some leadership out of these
systems.
I want to editorialize. I am deeply concerned about
proposed budget cuts this year in AHRQ's budget. If you proceed
with the current budget, the Agency for Health Care Research
and Quality will be unable to fund any new investigative
research. It goes to zero, except in specific targeted areas.
Now, you have made safety a targeted area, but that doesn't
solve the problem. Without investigator-initiated research, we
are not going to get the learning we need in this field. If you
do give AHRQ the funds it needs to support investigator-
initiated research, it is a wise investment in how to manage a
$1.5 trillion system, and I fear we are about to make a big
mistake.
Second, ask CMS to sponsor some market area experiments to
reward quality and safety. Right now a hospital or health
system that reduces injuries to patients actually takes a
financial loss often because it gets paid for treating the
consequences of its own injuries. We have to figure out how to
stop paying for defects in care and start putting the opposite
incentives to work: grants, tax credits, low-interest loans.
There is some current legislation on this, but right now we are
paying for defects and we have got to stop doing it.
Third, I think we should, with all due respect to Mr.
Stark, create a circumstance in which one, at least one State
in this country can try a no-fault malpractice liability
system. I think it will work. Here is the system we should try.
It should have six properties:
Always let patients and families know when a patient is
injured, extreme honesty, and you are not in the system if you
don't adopt that.
Second, apologize. We have trouble saying we are sorry.
Third, compensate the victims of energy directly and fairly
and promptly. Right now only 2 percent or 3 percent of the
money that is being exchanged in the system is actually going
to victims of injury.
Fourth, bear the responsibility at the entity level. Let
the hospitals, the health systems, bear that responsibility.
Don't go to the personal individual blame level, because that
is going to increase the fear that is our problem in getting to
safety cultures.
Fifth, learn from the events, continually reduce risks
within and among organizations.
Sixth, deal differently with the criminal and grossly
negligent. That has to be done promptly and severely, and that
is 2 percent of the problem.
I think a test of this kind of system in one State or one
region of the country would teach us, and we win either way. If
it works, we learn that it worked; and if it doesn't work, we
learn it doesn't work and can move the agenda on.
The fourth recommendation to Congress is, create some
limited privilege for reporting on patient injuries for the
individuals who make the reports. I think Jim has shown in the
Michigan VA, we know from theory and practice in other
industries, if there isn't some form of protection for the
individual--I do not think it should extend to the entity, to
the hospital or the health system, but at the individual level
there has to be protection, or people are no fools, they won't
talk about things when that talk is going to come back to hurt
them.
Fifth, don't worry about constructing a large national
database on errors or injuries. It will be a waste of time and
money. We don't need it. We should fund AHRQ thoroughly, to
have a research database on this, and you are about to make a
mistake if you proceed with the current budget on that, but if
we fund the research work, that is all the data we need. We
don't need a massive national architecture on data on injuries.
Finally, ask CMS to adopt some simple information
technology standards. We really are stuck. It is one of the
reasons Danbury Hospital has to spend so much money. I can
explain this in questions if you want, but there are a few
decisions we could make about standard vocabularies for coding
in this country.
If CMS said, ``You must use these codes as a condition of
participation,'' we are done. It would be behind us, and then
we can have a national data backbone that would allow hospitals
and health systems to talk to each other, that would have saved
Danbury millions of dollars, and Congress is in a really
important position here. The CMS could actually make the
difference in getting us there.
We have made a great running start. I commend you for what
has happened, and now we have a few more jobs to do and we can
make it even better.
[The prepared statement of Dr. Berwick follows:]
Statement of Donald M. Berwick, M.D., President and Chief Executive
Officer, Institute for Healthcare Improvement, Boston, Massachusetts
Since the IOM Report, To Err Is Human, released in November, 1999,
the nation has made a great deal of progress in confronting the burden
of injury from health care. We have made the issue explicit and
visible. I think most consumers are now aware of the problem, which is
a step toward building will for change. Some hospitals have promised to
improve patient safety. A small, but significant, minority of hospitals
have begun to look for injuries and to try to measure their frequency.
Skillful experts, including some from other industries, have started to
help us.
Let me give you just a few highlights:
LA consortium of all stakeholders in the Pittsburgh
area has publicly announced that they will reduce medication
injuries and post-operative staph infections to zero. Similar
consortia in Whatcom County, Washington, and in Florence, South
Carolina, have made plans to improve medication safety
dramatically.
LThe Children's Hospital Corporation of America,
involving several dozen children's hospitals, has chosen
patient safety as its major care improvement agenda.
LFifty-seven hospitals from all over the US in a
collaborative called ``Quantum Leaps'' are now openly measuring
their medication injury rates, comparing them, learning from
each other, and aiming for ten-fold reductions.
LA newly launched medical journal called ``Quality
and Safety in Health Care'' is providing researchers and
clinicians in the US and the UK with an outlet to publish their
work.
LThe National Academy of Engineering and the
Institute of Medicine have launched a project to see how new
engineering approaches can be applied rapidly and directly to
safety in health care settings.
LThe VA and NASA have begun a fascinating
collaboration on reporting systems and on human factors
engineering.
The Federal government has been in the lead in this sea change. I
think you already know that the Veterans Health Administration, the
Department of Defense, the Health Services and Resources
Administration, and, above all, the Agency for Health Care Research and
Quality have invested heavily in new care initiatives, technologies,
and research to make patients safer. The Quality Interagency
Coordinating Task Force (QuIC), which has bridged two administrations,
is a wonderful example of cooperative learning and action among
agencies that too often in the past have not worked closely together on
common issues. We would be nowhere near as far along as we are without
this Federal leadership, and I commend both Congress and the Executive
Branch for your commitment and bipartisan constancy on this issue.
Along with this important progress, we have also now become aware
of some obstacles. None of them are insurmountable, and in some cases,
the Federal government can clearly help to accelerate change. Here are
a few of the problems that have surfaced:
LFirst, persistent denial. Many clinicians and
organization still seem to think, despite the evidence, that
the problem of safety is not as large as we know it to be. This
denial is fading fast, and I think we are well into a new era
of recognition and aims for improvement. It remains important
for Congress, Federal agencies, and other leaders to keep the
pressure on, and to insist on improvements.
LSecond, capital costs. Health care systems are
facing--or at least say they are facing--investment barriers to
adopting some important technologies that make care safer, most
importantly computerized physician order entry--CPOE. Correctly
adopted, CPOE can reduce medication errors by as much as 80%,
but it requires a level of computerization that the health care
industry largely lacks. The technologies cost hospitals a lot
up front--millions of dollars--$7.5 million on average
according to a recent estimate, and some hospitals say they
lack sufficient sources of capital. CPOE in the long run saves
money; one study said it reduces hospital costs 13%. The
American Hospital Association has found that hospitals with
good Information Technology support generally cost less and
have better outcomes than others. The barrier is getting from
here to there; it's a transitional problem.
LThird, paying for defects, instead of for safety
and quality. Our system of financing still often pays well for
poor care. A hospital that reduces patient injuries can today
experience a significant decline in revenue, since it would
often otherwise get paid for managing the consequences of those
injuries. This is not a stopper for ethical hospitals, and most
are ethical, but it is a problem.
LFourth, lack of standardization. Facing high
capital costs, health care organizations are nervous about the
lack of standards for coding and procedures, fearing that they
could invest today in systems that could rapidly become
outmoded or incompatible in the future. Lack of standardization
is an impediment to progress, and I see no force other than the
Federal government able to create such standards rapidly and at
a national scale.
LFifth, and perhaps most important, fear. For many
reasons--threats of lawsuits, embarrassment, loss of market
share, and others--organizations and individuals in health care
are frightened to discover, reveal, and openly address defects
in their care. This fear is incompatible with learning and with
safety, itself. Safe systems are open systems, and a frightened
workforce cannot properly address safety improvement.
Along the way, we have all been a little distracted by the very
contentious issue of public reporting of patient injuries. It is
contentious because, on the one hand, it seems only right that the
health care industry should be disclosing its performance to the people
who depend on it and pay for it. I hope and believe that we are
emerging overall from the era of secrecy about performance of care
systems, and the more recent IOM report, Crossing the Quality Chasm,
called unequivocally for a whole new level of commitment to
transparency, not just to inform consumers, but to allow health care
systems, themselves, a better chance to learn from each other. Safety
is important, and it is illogical to exempt it from the rule of
transparency.
On the other hand, we do know that people in health care are
running scared, and that a frightened workforce hides its defects
instead of learning from them.
And so, we have gotten a little stuck since the IOM safety report.
A few courageous health care organizations have just gone ahead and
become open about measuring safety, and, I must say, they are none the
worse for it. Most, however, are still pretty timid about it. They
fight disclosure, and they fight CMS when they propose that safety
should be openly measured and discussed.
In my opinion, it is high time to leap over our shadow on this one.
I simply do not believe that a risky, complex, stressed industry will
have the will or the knowledge it needs to move beyond traditional
assumptions about achievable performance unless and until it faces
facts and data on its own work. Safety should be a topic openly
discussed, openly assessed, and openly explored, and I hope that CMS,
like other important purchasers, will do what it can to assure that
that open dialogue becomes more and more widespread. CMS should insist
that the health care organizations it pays must assess, study, and
learn about their own patient injuries, disclose those injuries to the
patients who are harmed, and continually and demonstrably reduce the
risks of injury.
Congress can help this maturation to occur by a few, simple,
persistent steps:
1. Continue to support the investments of the VA, HRSA, DoD,
and, most crucially, AHRQ, in the agenda of learning and
improvement of patient safety, for the benefit of their
patients, and for the instruction of all.
I am deeply concerned about this year's proposed reductions in
the budget of AHRQ. It would be wise to expand, not to cut, our
nation's meager investment in studying how our $1.5 trillion
care system can be made better continually. Preserving line
items for patient safety research is helpful, but not at all
sufficient. Please understand that the proposed AHRQ budget
would bring nearly to a standstill new investigator-initiated
health services research proposals--bring them to zero--and
that means a sudden slowing down of research and investment
which ultimately has a major impact on the well-being of our
patients. If you give AHRQ the funds it needs to support
investigator-initiated research, even more than in the past,
you can count on a high rate of return in health care quality
improvement.
2. Ask CMS to sponsor and allow several market-area experiments
to reward quality and safety. Try to adjust payment streams so
that health care organizations that become safer thereby become
more viable. Right now, a hospital or health system that
reduces injuries to patients often actually loses financially,
because it gets paid for defects. We have to figure out how to
stop paying for defects in care, and to start putting exactly
the opposite incentive to work. Pay hospitals more when they
reduce their injury rates, and less when they don't. Grants,
tax credits, or low-interest loans, as some currently proposed
legislation would offer, may help some of the less wealthy
hospitals move faster into modern information systems.
3. Create the circumstance in which at least one state or area
can test a no-fault malpractice liability system for a few
years, so that we can begin to put to rest the most commonly
cited obstacle to openness. Either we will learn that that
leads to much more openness, or that it doesn't, and, either
way, we gain knowledge we badly need. The system we most badly
need to test would have the following components: (a) always
letting patients and families know when a patient is injured by
care (``extreme honesty''); (b) apologizing; (c) compensating
victims of injury fairly and promptly; (d) bearing this
liability at the ``entity'' level (hospital, health care
system), not at the personal level (physician, nurse); (e)
learning from events, and continually reducing risks within and
among organizations; (f) dealing differently and promptly with
the small class of criminal and grossly negligent events.
4. Create some limited privilege for reporting on patient
injuries for the individuals who make those reports. I am not
asking for secrecy at the entity level, but rather for some
protection for a doctor or nurse who sees something go wrong,
or actually falls into some pattern of error, and who can and
will talk about it, but only if that does not come back to hurt
them.
5. Do not worry about constructing some massive national
database on errors or patient injuries. We don't need it. It
may help if AHRQ has a research database of that type, but
regional and statewide reporting systems will be quite enough
if we also have ways for the people involved in those systems
to meet and talk with each other and to share what they are
learning.
6. Ask CMS to adopt some information technology standards,
required of those organizations they pay, for coding of
messaging, medications, laboratory tests, and diagnoses. It is
important, and feasible, for CMS to select a single set of such
standards from among several good available options, and then
to build confidence in the health care system that these will
remain stable for a considerable time, so that it becomes
prudent and logical to invest in compatible data systems with
confidence that they will work well into the future. That will
make CPOE and other safety-enhancing computer technologies much
more attractive and feasible. I also think CMS should join the
Leapfrog Group in informing hospitals that, by some deadline, a
hospital without either CPOE or a demonstrably better method
for medication safety cannot be a Medicaid provider.
We really have a running start now on making health care safer.
We need to keep the heat on the topic, invest in the research
to know how to improve the situation, insist on openness and
sharing, pay more for quality than for defects, and make it
both important and safe for the wonderful people who work in
health care to learn about their own errors, about the harm
done to patients, and about how to reduce that harm
continually.
Chairman JOHNSON. Thank you very much.
Ms. Foley, President of the American Nurses Association.
STATEMENT OF MARY FOLEY, PRESIDENT, AMERICAN NURSES ASSOCIATION
Ms. FOLEY. Thank you, and good morning. I really do
appreciate the opportunity to be here and return to the table
to talk about the importance of prevention of health care
injuries.
As you know, there are more than 2.7 million registered
nurses in the country right now, 2.2 million of us are still
working in the field. We are very committed, and it has always
been a cornerstone of our nursing profession to be worried
about and try to attend to the issues of patient safety.
Of course, as you have mentioned, Congresswomen, the
landmark report ``To Err is Human'' really brought this
attention to the forefront. It was the most talked-about health
care issue in the year 2000, and while I do also agree with our
previous speakers, there has been some good work started, we
need to continue to push on the issue of systems of care and
systems of safety that protect our critically important
patients.
I am here, however, to put a slightly different face on the
discussion because the system of safety cannot overlook the
people who provide the safety net and the monitors of safety,
and for us nurses play that role in a very critically important
manner.
We have long maintained, and we are beginning to get some
significant research which validates the relationship between
high quality, safe patient care and the amount and the skill of
the nursing staff, and we applaud the research that has been
supportive of those findings. The CMS and four U.S. Department
of Health and Human Service agencies in the years 2000 and 2001
have reported correlations between safe staff and certainly the
reduction of complications and injuries such as falls.
I support, as does nursing, the implementation of
technology, for example, computer order entry, but the pursuit
of technology should not be in a vacuum. it must consider the
people who will then be part of that system. I think Dr. Miller
mentioned the training, but importantly as well the people who
provide the care and do the actual monitoring and assessment
are just as critical to a good computer order entry system, so
the pharmacists and the nurses have to be present in adequate
numbers and with qualifications that are commensurate.
We also know, as I have mentioned, that--well, so on the
issue of staffing, I just want to reiterate that we are
recommending then efforts to support valid and reliable
staffing measurements that really address what are the needs or
the acuity of our patients, and that that concept be integrated
into Medicare and Medicaid programs as a form of condition of
participation.
We very strongly applaud the efforts of the Veterans
Administration. They are demonstrating the best practices,
particularly in the area of early reporting and near miss
analysis, and I think that is a field that needs to be further
promoted and supported.
Additionally, we are very concerned about skilled nursing
facilities. I have been very alarmed by the reports that we
have heard. Nurses are not surprised, however, by some of the
shocking findings that we are hearing about care in skilled
nursing facilities. We continue to support adjustable minimum
nurse-patient ratios in those settings.
Let's talk about the issue of mandatory overtime. Again,
the system of care and the human factors involved in the safe
delivery of care, there is inadequate research. It is beginning
to be performed. We have one particular study, an AHRQ-funded
study, to look at nurses and fatigue.
Over two-thirds of nurses in a survey last September told
us that they are being asked to work unplanned overtime, and of
course the epidemic of mandatory overtime has been both a very
negative image for nurses, it is affecting our ability to
recruit and retain, and we know we have a shortage coming. More
importantly, we are very concerned about the safety of nurses
who feel that they are too fatigued to provide safe care, and
there are ample studies that show that fatigue has a
correlation to injury and safety issues. So we do support
Congress's continued discussion and support for the Safe
Nursing and Patient Care Act of 2001, which we think is a
balanced approach.
Let me just quickly mention the reporting, the role of the
whistle-blowing. Mr. Stark, thank you for mentioning that, very
much. The ability to safely report, in fact the enhancement of
safe reporting mechanisms is very important to nursing. If we
cannot speak out and let people know when we see care that is
inadequate or unsafe or lax quality and there are negative
repercussions, it will be difficult to be the full advocate
that we believe we must be and that we should be.
So, in conclusion, I would like to just continue to support
this system approach, but the people as part of that system
must be considered. They have to be able to be there. All
nurses want to do, and I have said this many times, all nurses
want to do is give good care. We must attend to the people and
the equipment and to the technology that makes that care
possible.
I would have to say, very importantly, though, Congressman,
you asked us about the cost. The alternative to a safe system
with adequate staff is the cost of untold numbers of injuries,
errors, terrible patient satisfaction, and the cost of that
type of system is unacceptable. I am a believer in prevention.
I believe the investment in a safe environment with adequate
staff who are well qualified and well cared for will indeed pay
dividends over the many years to come.
Thank you.
[The prepared statement of Ms. Foley follows:]
Statement of Mary Foley, President, American Nurses Association
Good morning Madam Chair and Members of the Subcommittee, I am Mary
Foley, MS, RN, president of the American Nurses Association. Thank you
for the opportunity to discuss our concerns regarding patient safety
and medical errors. ANA is the only full-service association
representing the nation's registered nurses (RNs) through its 54
constituent nurse member associations. Our members include RNs working
and teaching in every health care sector across the entire United
States. I myself have more than 25 years experience as a staff nurse, a
nurse executive and a clinical instructor in nursing.
Numbering more than 2.7 million, nurses are the largest health care
workforce in the nation. From the nurse midwives who attend delivery,
to geriatric nurse practitioners who manage end-of-life care, to staff
nurses who care for us during times of acute injury or illness, nurses
are integral to health care across the human lifespan. We touch
patients and manage teams of medical professionals in hospitals,
clinics, community health centers, offices, nursing homes and patient's
homes. We are the ones who will ultimately implement and be impacted by
new patient safety initiatives. Therefore, nurses have a substantial
contribution to make to the developing debate on medical errors.
The issue of patient safety has always been the cornerstone of
nursing. The Code of Ethics for Nurses clearly states that ``as an
advocate for the patient, the nurse must be alert to and take
appropriate action regarding any instances of incompetent, unethical,
illegal, or impaired practice by any member of the health care team or
the health care system or any action on the part of others that places
the rights or best interests of the patient in jeopardy.'' ANA has been
active in the debate on medical errors, both prior to the release of
the Institute of Medicine (IOM) study To Err is Human and since it
publication. This statement provides a summary of our actions and
positions, and our requests for future policy.
The Changing Health Care Delivery System
The landmark IOM report To Err is Human (1999) described a
fractured health care system that is prone to errors and detrimental to
safe patient care. This problem is readily apparent to the nurses who
have been caught inside the topsy-turvy world of our rapidly changing
health care delivery system. We have seen market forces, reimbursement
changes, and new technologies revolutionalize health care.
Unfortunately, these changes have not always resulted in better patient
care.
In the past decade, the advent of managed care and changes in
Medicare reimbursement have exerted downward pressure on provider
margins. As a result, health care facilities have employed radical cost
reduction programs. Throughout the 1990s, new models of health care
delivery were implemented, and highly-trained, experienced--and
therefore higher paid--personnel were eliminated or redeployed. As RNs
typically represent the largest single expenditure for hospitals
(averaging 20 percent of the budget), we were among the first to feel
the pinch. Often lesser-skilled, lower-salaried assistive staff were
hired as our replacements. Nationally, nurses wages were cut and RN
employment in the hospital sector decreased. Accordingly, it was only
five short years ago when nurses were being laid off in droves.
At the same time, recent advances in medical technology have
resulted in truly amazing treatments and procedures. These advances are
extending and improving the quality of our lives. They are also
increasing the complexity of health care. Just think of premature
infants in neonatal units or the burn victims from the recent terrorist
attacks; these patients are able to survive and thrive when only a few
years ago they could not. Nurses in these units manage patients who are
supported by heart-lung bypass machines, ventilators, and constant drug
infusers. Patients such as these require constant monitoring, as even
minute changes can quickly lead to disaster. Thus, today's nurses are
engaged in painstaking, complicated care more often, with fewer
supports than ever before.
In sum, recent changes in health care delivery have increased the
pressure placed on staff nurses who are now required to oversee
unlicensed aides while caring for a larger number of sicker patients.
At the same time, the elimination of nurse managers has decreased the
support, advocacy and resources necessary to ensure that staff nurses
can provide optimum care.
The Failures of the Culture of Blame
In addition to the changes described above, the recent increase in
competition within and among health care providers, as well as the
upswing in public concerns about the quality of health care, have lead
institutions to focus on their marketability. ANA is concerned that
many institutions have responded to this pressure by creating a
punitive atmosphere that continues to assign and emphasize individual
blame for errors, misjudgements and patient dissatisfaction. These
facilities continue to assume that the appropriate way to deal with
patient care problems is to increase the oversight and discipline of
health care workers; as opposed to identifying and resolving central
system problems.
Although a range of sanctions are available to punish providers
held responsible for committing medical errors, these measures are
rarely credited with much success. Professional licensing boards are
often backlogged and sometimes criticized for failure to take
appropriate disciplinary action. Legal avenues reach only a fraction of
the injuries caused by health care error. Most importantly, regulatory
and legal sanctions are only imposed after mistakes have been made and
do very little to prevent them in the first place.
This is not to say that providers and practitioners who are
negligent or incompetent should not be removed from clinical practice.
Certainly, we must be able to deal with people who are unable to
practice safely. ANA maintains that mechanisms for individual
accountability should be maintained. We also contend that an over
reliance on individual scrutiny has failed to address the burgeoning
system problems that have fostered poor patient care.
The Role of Appropriate Suffering
ANA has long maintained that the safety and quality of care
provided in the nation's health care facilities is directly related to
the number and mix of direct care nursing staff. More than a decade of
research shows that nurse staffing levels and skill mix make a
difference in patient outcomes. Studies show that where there are more
nurses, there are lower mortality rates, shorter lengths of stay,
better care plans, lower costs, and fewer complications. In fact, four
HHS agencies--the Health Resources and Services Administration (HRSA),
Health Care Financing Administration (now the Centers for Medicare and
Medicaid Services, or CMS), Agency for Healthcare Research and Quality
(AHRQ), and the National Institute of Nursing Research (NINR) of the
National Institutes of Health (NIH)--recently sponsored a study on this
topic. The resulting report, released on April 20, 2001, found strong
and consistent evidence that increased RN staffing is directly related
to decreases in the incidence of urinary tract infections, pneumonia,
shock, upper gastrointestinal bleeding, and decreased hospital length
of stay.
CMS, the IOM, the General Accounting Office, and numerous
professional and consumer organizations have found similar evidence
regarding the relationship between nurse staffing and patient care in
nursing facilities. An ongoing study commissioned by CMS has detailed
the relationship between insufficient nurse staffing and increases in
bed sores, urinary tract infections, sepsis, and weight loss in nursing
home residents.
A recent ANA staffing survey, involving 7,300 RNs, reinforces the
connection between adequate staffing and quality of care. This report
shows that 75 percent of respondents felt that the quality of nursing
care at their facility has declined over the past two years. More than
5,000 nurses (68 percent) cite inadequate staffing as a major
contributing factor to the decline in quality of care. More than half
believe that the time they have available for patient care has
decreased. The public at large should be alarmed that more than 40
percent of the respondents to the ANA survey state that they would not
feel comfortable having a family member cared for in the facility in
which they work.
ANA maintains that something must be done to address staffing
concerns. Adequate staffing levels allow nurses the time they need to
make patient assessments, complete nursing tasks, respond to health
care emergencies, and provide the level of care that these patients
deserve. Adequate staffing also increases nurse satisfaction and
reduces turnover. For these reasons, ANA supports efforts to require
acute care facilities to implement and use valid and reliable staffing
plans based on patient acuity as a condition of participation in the
Medicare and Medicaid programs. We are excited about the advances that
the Veteran's Administration has made in patient safety, and we look
forward to working with the Veteran's Health Administration officials
as they develop a new national nurse staffing policy. In addition, we
support efforts to enact upwardly adjustable, minimum nurse-to-patient
staff ratios in skilled nursing facilities.
The Critical Problem of Mandatory Overtime
By far the riskiest result of understaffing is the abuse of
mandatory overtime as a staffing tool. Nurses across the nation have
told me their concerns about the dramatic increase in the use of
mandatory overtime. ANA hears that employers are insisting that a nurse
work an extra shift (or more) or face dismissal for insubordination, as
well as being reported to the state board of nursing for patient
abandonment.
The use of mandatory overtime is not as uncommon or isolated as
some would have you believe. In fact, the term `mandation' has been
coined by the health care industry to describe this staffing tool. A
recent ANA survey (sample size 4,826) revealed that two-thirds of
nurses are being required to work some mandatory or unplanned overtime
every month.
ANA's concerns about the use of mandatory overtime are directly
related to patient safety. We know that sleep loss influences several
aspects of performance, leading to slowed reaction time, failure to
respond when appropriate, false responses, slowed thinking, and
diminished memory. In fact, 1997 research by Dawson and Reid at the
University of Australia showed that work performance is more likely to
be impaired by moderate fatigue than by alcohol consumption. Their
research shows that significant safety risks are posed by workers who
stay awake for long periods. Thus, it only stands to reason that an
exhausted nurse is more likely to commit a medical error than a nurse
who is not forced to work overtime.
Nurses are placed in a unique situation when confronted by demands
for overtime. Ethical nursing practice prohibits nurses from engaging
in behavior that they know could harm patients. At the same time, RNs
face the loss of their license--their careers and their livelihoods--
when charged with patient abandonment. Absent legislation, nurses will
continue to confront this dilemma. For this reason, ANA supports the
Safe Nursing and Patient Care Act of 2001 (H.R. 3238, S. 1686) which
would ban the use of mandatory overtime through Medicare provider
agreements.
ANA supports working through the Medicare system because we believe
that the abusive use of overtime promotes poor patient care and
therefore is a matter of public health safety. Just as limits on work
hours for airline pilots, flight attendants, and truck drivers are
enacted through transportation law, we believe that this matter should
be handled through health law. The Safe Nursing and Patient Care Act is
a fair, measured response to the abuse of mandatory overtime. ANA
strongly encourages all Members of this Committee to support its
enactment.
Patient Advocacy and Whistleblower Protections
In addition, ANA maintains that nurses must be able to speak out
about quality-of-care problems without fear of retaliation or the loss
of their jobs. Patient advocacy is at heart of nurse's professional
commitment. In turn, patients depend on nurses to ensure that they
receive proper care. Patients must be assured that nurses and other
health care professionals, acting within the scope of their expertise,
will be able to speak for them without fear of reprisal.
Whistle blowing by nurses usually results from concern about issues
that jeopardize the health or safety of patients, or occupational
safety and health violations that place the employee at risk. Yet, even
though we are responsible for patient care and well-being, nurses are
often powerless when another health care provider performs unethical or
life-threatening practices. Retribution and dismissal for whistle
blowing are not uncommon. In fact, there have been a number of legal
cases involving nurses who have been retaliated against for ``blowing
the whistle'' on their employers.
Current whistle-blowing laws remain a patchwork of incomplete
coverage. For example, the False Claims Act contains a whistleblower
provision that applies only in cases of fraud or misuse of Federal
funds. The Emergency Treatment and Labor Act (EMTALA) includes
protections for patient advocacy, but only for personnel working in the
emergency department of a hospital. The Whistleblower Protection Act of
1989 only applies to federal employees (e.g., VA nurses). This
confusing, incomplete coverage leaves many nurses fearing reprisals
such as dismissal, harassment, and blacklisting. This lack of a blame-
free reporting system prevents many nurses from taking the risk of
trying to protect their patient's health and safety. In order to allow
nurses to function as successful patient advocates, effective
whistleblower protections for nurses who report unsafe patient care
must be enacted.
Where to Start?
A number of experts, including those sitting here with me today,
have proposed valuable solutions to the problem of medical errors and
patient safety. ANA supports many of these initiatives; however we
insist that the central issues of staffing, overtime and whistleblower
protections must not be lost in this debate.
Medication errors serve as a good example. The IOM estimates that
medication errors increase hospital costs by about $2 billion per year.
Disturbingly, the IOM also estimates that the number of lives lost to
preventable medication errors alone represents over 7,000 deaths
annually--more than the number of Americans injured in the workplace
each year. The U.S. Pharmacopeia, which has tracked medication errors
since 1991, recently reported on the first full year of an internet-
based reporting mechanism for medication errors and near misses. The
analysis of 6,224 reports revealed that most errors occur in the
administration of medications--the delivery to the patient. U.S.
Pharmacopeia reports that, ``the primary contributing factor to
medication errors were distractions and workload increases, many of
which may be a result of today's environment of cost containment.'' ANA
could not agree more. While we support innovations such as information
technology designed to reduce medication errors, we understand that
these efforts will not be successful if the broader system issues are
not addressed as well. In the end, any system that requires a nurse to
work a 16-hour shift, while caring for too many critically ill
patients, in a ward where he or she is not supported by adequate staff
is destined to failure.
Conclusion
Madam Chair, I have been a registered nurse for more than 25 years.
I have been a staff nurse, a nurse executive, and a clinical instructor
in nursing. I know something about nurses. We are called to the
profession by a desire to provide compassionate care to people in need.
Believe me, no one becomes a nurse for the money. We are driven by a
desire to provide safe, high-quality health services. We will remain in
patient care as long as this is possible.As long as unreasonable
schedules, dangerous understaffing, and fears of institutional reprisal
keep nurses from meeting this calling, many will continue to leave the
bedside. Nurses do not want to be a part of a health system that fails
to meet the needs of patients. Registered nurses, hospital
administrators, other health care providers, health system planners,
and consumers must come together in a meaningful way to create a system
that supports both patients and health care providers. We should begin
by improving the environment for nursing.
Chairman JOHNSON. Thank you very much.
Dr. Feinstein, Chair of the Pittsburgh Regional Health
Initiative from Pittsburgh. Welcome.
STATEMENT OF KAREN WOLK FEINSTEIN, PH.D., PRESIDENT, JEWISH
HEALTHCARE FOUNDATION OF PITTSBURGH, PENNSYLVANIA, AND CHAIR,
PITTSBURGH REGIONAL HEALTHCARE INITIATIVE, PITTSBURGH,
PENNSYLVANIA
Dr. FEINSTEIN. Thank you, Madam Chair. I also want to
express the regrets of Secretary O'Neill, who is in Kuwait, who
would be here to testify. His testimony is on the table.
Secretary O'Neill and I, before he was Secretary, Co-chaired
the initiative that you referred to, the Pittsburgh Regional
Healthcare Initiative, which we view as a vast learning network
involving the total collaboration of all the hospitals in our
region to reduce medical error, hospital-acquired infection,
and most importantly, Madam Chairman, to follow through on what
you suggested, which is the critical systems redesign on all
levels, so that people within health care can do things right.
That is so critical to us because getting to the root cause
of patient safety issues really isn't another layered-on
activity with all the other things we layer on at the hospital
level, but it is part of a total systems redesign, a new way of
regarding the health care enterprise that is so critical to
overall process improvement.
At the moment, we are the first region in the country where
competing hospitals have come together in total collaboration,
to count every medication error and infection, count them the
same way, and share that information openly. Thirty hospitals,
twenty corporations, four health plans, a small business
purchasing coalition, hundreds of health professionals have all
come together, many of whom have signed contracts pledging
themselves to work toward zero perfection goal in medication
errors and in hospital-acquired infections.
As I wanted to mention, even though we have come together,
we have all installed the same databases and we are using and
sharing information, I do want to assure you, because this
issue has been raised, our hospitals are no less rancorous and
competitive than any others. As I like to say, our health
system is just as sick as any other community's. It is not
because everybody gets along in Pittsburgh that we are able to
collaborate.
The reason we have been able to come together is a
collective awareness of the scale of the problem, of the errors
that plague our hospitals and the overall system errors, not
just medication and infection, that result in waste, overuse,
inefficiency, and often a lack of applying the best practices
even though there is good knowledge to suggest what we should
be doing.
The core in our mind of what was wrong is that our systems
have lost a collective focus on helping care teams deliver the
right care every time for every patient, which leads to the
inevitable imprecision, waste, and errors about which we have
convened today. When we realized that the systems issues were
the root of the problem, we wanted to look at a powerful model
for process improvement, and we turned to Alcoa. We couldn't
find anything as powerful.
We wanted to look at some organization, that had adopted a
successful framework for quality and safety, so we went to
Alcoa. Alcoa is headquartered in Pittsburgh, and it had the
best safety record in the world. Think of this, it is 18 times
safer to work in Alcoa with molten metal and sheaves of
aluminum, all four edges are like knives, than it is to work in
your average hospital.
So we were looking for something powerful in the way of
process improvement that would move us to the kind of systems
change that we had seen at Alcoa, engaging every professional
at the point of care in becoming an improvement scientist,
helping everyone look at each problem, each error, as an
opportunity for learning, for the root cause analysis,
experimentation, measurement, and shared learning you have
heard here.
I would like to echo Don Berwick's comments. We really
couldn't be doing what we are doing now in our collaboration,
with our databases installed to capture our hospital acquired
infection data and the shared learning that is going on,
without the Centers for Disease Control Prevention (CDC)and
their NNIS, the National Nosocomial Infectious Surveillance,
system for measuring infection.
Obviously, good data entry, analysis, attempting solution
and then sharing the learning, are essential. Believe me, the
databases alone, without the support in how to use them and how
to gather learnings, wouldn't get us to where we are.
Let me quickly say, the kind of support that we would love
to have, that we would need from the Federal government to get
to this system of perfect patient care to which we aspire, is
increased confidentiality protections. We can't deal with
errors, we can't solve them to root cause, without
confidentiality protection.
Second, we need support for an environment where these
clinical data systems and other methods we are using to get
better patient outcomes, where constraints are removed, rewards
are introduced. Expanding a Federal partnership, working with
CMS, AHRQ, CDC, and others to continue doing this is incredibly
important to us.
One of our most powerful learning tools as well as our
databases is observation. We want to engage the appropriate
Federal agencies in direct learning and more collective
observation at the point of care, to see where rules and
regulations and other constraints impede our efforts to bring
about the systems change.
We suggest Federal support for more demonstrations applying
successful industrial models, such as the Toyota Production
System model we are using, in local hospitals. We would also
like to see training in safety, both worker and patient safety
and systems improvement, a core component of the education of
all health professionals.
We would also like to see more medical research and
education funding dedicated to improving quality of care
delivery at the point of care. We need new knowledge about how
to deliver health care, and how to apply the knowledge we
already have more perfectly. Along with that, of course, I
would like to suggest we would benefit from experiments in
methods of payment that provide incentives for doing the right
thing at the right time. We have tried very hard to enlist the
professionals at the point of care as the driving force in our
initiative. I want to emphasize how important I think that has
been to us, and the fact that they are allowed to experiment
and come up with their own solutions is a critically important
learning tool.
Thank you very much.
[The prepared statement of Dr. Feinstein follows:]
Statement of Karen Wolk Feinstein, Ph.D., President, Jewish Healthcare
Foundation of Pittsburgh, Pennsylvania, and Chair, Pittsburgh Regional
Healthcare Initiative, Pittsburgh, Pennsylvania
Chairman Johnson, Congressman Stark and distinguished Members of
the Committee:
I am Karen Wolk Feinstein, Chair of the Pittsburgh Regional
Healthcare Initiative (PRHI)--a community-wide effort to establish
Southwest Pennsylvania as the world leader in patient outcomes--
including perfect patient safety.
On behalf of the more than 30 hospitals, 20 corporations, four
health plans, small business purchasing coalitions, unions, government
officials, and hundreds of physicians, nurses pharmacists and other
clinicians that constitute PRHI, it is an honor to be asked to testify
today.
Two days ago, in downtown Pittsburgh, CEOs from the region's
competing hospitals met to openly review patient safety incidents in
their institutions and to discuss powerful leadership approaches to
address those errors. Today, I'd like to tell you why this is happening
in our community, describe help we have already received from federal
partners, and note how federal policy can help efforts like ours, if
the intention is to fix healthcare systems ``from the bottom up.''
For us, addressing safety issues is not adding another layer of
activities for hospitals and other healthcare providers. Achieving safe
practices is integrally connected to the entire process of restoring
each patient to health as quickly as possible.
To err may be human, but failure to share those errors, learn from
them, and prevent them from happening again is unforgivable. Cloaked in
darkness, secrecy and fear of reprisal, medical mistakes are not used
for learning, so they are repeated. Like Sisyphus, we err and err again
because we do not fix our systems after each error to prevent future
ones.
That is why, in American health care today, a hospital patient has
a 7% chance of contracting a preventable hospital-acquired infection
during their care, and a 2.3%-4.6% chance of being damaged by a
medication error.
The scale of damage is stunning. Recent anthrax attacks took five
innocent lives. Healthcare-acquired infections are associated with
88,000 deaths each and every year, and afflict more than two million
Americans a year. The direct financial cost of caring for these
infections in our region alone exceeds $110 million per year. In fact,
our first data sharing efforts show that just one type of infection
(blood stream infections) in intensive care units costs our region $15
million a year. As this Subcommittee knows, the story isn't any better
for medication errors. They wound or kill approximately 770,000
Americans annually. But these aren't the only costs associated with
errors.
The reason errors occur at shocking rates is also the reason why
the American healthcare system is staggering on so many fronts,
including escalating costs and rising dissatisfaction among all
healthcare workers. What is that reason? We have lost our collective
focus on helping care teams deliver the right care, every time, for
every patient. Imprecision, waste, and errors are inevitable.
To regain our focus on the patient and to learn how to create a
better performing healthcare system in our region, more than 30
hospitals and PRHI's other coalition members have formally committed to
working together to eliminate medication errors and healthcare-acquired
infections. (PRHI hospitals are also working to perfect patient care in
six areas of clinical medicine).
In setting this framework for change, we drew our inspiration from
Alcoa, which is based in Pittsburgh, and PRHI's founding Chair, now-
Treasury Secretary Paul O'Neill. In 1987, when Secretary O'Neill became
its CEO, Alcoa publicly committed to eliminating workplace injuries.
Over the next 13 years, all of its employees worked together to learn
how to do so, from the maintenance worker in Brazil to the CEO in
Pittsburgh. Alcoa is now the safest workplace in the world. In 2002,
Alcoa--a heavy manufacturing company with 140,000 employees in 37
countries--is 18 times safer to work in than the average hospital.
It is no coincidence that over the same period, Alcoa experienced
dramatic overall gains in its business, becoming by far the world's
largest, most efficient and most profitable aluminum producer.
To move decisively toward those kinds of results in our community's
healthcare delivery system, we have become the first region in the
country where competing hospitals have begun efforts to count every
medication error and infection, count them in the same way, and share
that information openly for the purposes of learning.
We have had extraordinary help from federal agencies and national
resources. The Centers for Disease Control in Atlanta has been a
generous strategic partner in attacking healthcare-acquired infections.
Recognized as a world authority in infection control and public health,
the CDC has been collecting hospital-acquired infection rates through
the National Nosocomial Infection Surveillance System (NNIS) for 30
years. NNIS has, however, historically been available only to hospitals
that meeting rigid criteria, due to funding and other constraints. CDC
generously made a variant of its NNIS system available to each PRHI
hospital. CDC also provides extensive on-site instruction and support
for our efforts. Our first shared target for surveillance and
improvement, initiated April 1, 2001 has been a catastrophic type of
blood stream infection occurring in intensive care units. We are moving
on to other critical infection types this year.
To report and learn from medication errors, PRHI's partner
hospitals have all agreed to use U.S. Pharmacopoeia's MedMARx system, a
web-based error reporting tool that allows healthcare workers to
describe errors and their contributing causes according to the most
credible national standards, and to learn from the experiences of other
hospitals in the system. PRHI hospitals share their information
regionally as well as nationally. Pittsburgh area hospitals constitute
less than 5% of the hospitals contributing error reports to MedMARx,
but have provided approximately 15% of the errors reported to MedMARx
to date. This does not mean that Pittsburgh hospitals have more
medication errors. On the contrary, just that they are more committed
to error reporting--the first critical step in error prevention.
In September, our patient safety efforts were given a critical dose
of support from the Agency for Healthcare Policy and Research (AHRQ).
Under a generous AHRQ grant for studying the implementation and use of
patient safety reporting systems to the University of Pittsburgh, PRHI,
and a number of local and national research partners, including
Carnegie Mellon University, RAND and Purdue University, we will
accelerate the pace of our patient safety programs by refining how to
translate the information contained in patient safety reports into
knowledge in front-line healthcare workers that actually protects
patients. With AHRQ support, we can also generate insights to share
with the rest of the country regarding effective and less effective
strategies. AHRQ has constructed a national learning network for
grantees that will be an important resource for us.
The direct support of these federal agencies, together with a
generous grant from the Robert Wood Johnson Foundation and a strong
base of funding support from local corporations and foundations, has
been indispensable.
We believe that federal health care policy can further aid efforts
like ours, if it addresses the root cause of under performing health
delivery systems and supports strategies for reducing error and
improving performance at the point at which patients are cared for.
Enlightened federal policy can succeed where previous ``quick
fixes'' have failed if it relies less on mandates, regulation and
punishment, and more on helping health care teams get care right by
creating learning networks. Here are some key steps:
LIncreasing confidentiality protections for reporting
and learning from medical errors without lessening a patient's
right to information about their own medical care. We cannot
stress how important an expanded zone of protection beyond
today's loophole-filled state peer review statutes for
discussion about medical errors will be to future progress.
When punishment, ridicule and legal exposure drive reporting
underground, learning does not occur. Like aviation, nuclear
energy and other high-risk industries, the government must act
decisively to protect the reporting, analysis and sharing of
information about errors and near misses. Extending the
confidentiality protections of Medicare's Peer Review
Organizations (now called QIOs) to reporting on all of an
institution's patients would be welcome, but healthcare
institutions will respond most powerfully if protection is
extended to other major error reporting systems, such as the
Joint Commission on Accreditation of Healthcare Organizations
(JCAHO) and MedMARx, particularly if the hospital is required
to participate.
LIncreasing support for the quality improvement
efforts of clinicians and institutions. The federal government,
together with allied organizations such as JCAHO and the
National Committee on Quality Assurance (NCQA), can and should
expand technical assistance efforts to support quality
improvement efforts within institutions and communities.
Government can also provide financial incentives for healthcare
institutions to install and use error reporting and prevention
systems, as well as clinical data systems that link processes
of care with patient outcomes. Helping to set universal
standards and definitions for these measurement systems would
also be a critical government contribution. The CDC and other
federal agencies are poised to help more institutions and
communities establish these kinds of critical learning
infrastructures, if resources can be made available.
LExpanding federal partnership with local communities
and rewarding local initiative. Just as government can increase
its investment in quality improvement efforts within individual
institutions, it can add enormous energy to community-wide
efforts like PRHI by participating in learning partnerships
with coalitions like ours. The problems in health care are too
complex to untangle from Washington. Only by getting out to
where care is delivered, and observing how we can help care
teams learn to deliver the best care precisely, will the path
to addressing America's continuing health care crisis become
clear. We are working with other like-minded health systems
improvement efforts around the country to establish just such a
grassroots learning network, and would welcome participation by
federal agencies.
We also recommend the following federal policy steps:
LInvest in demonstrations applying successful
industrial models, such as the Toyota Production System, to
health care. (We have such experiments underway at five local
hospitals).
LMake training in safety and systems improvement a
core component of medical education.
LIncrease medical research funding dedicated to
encouraging academic physicians and institutions to become more
deeply involved in measuring and improving quality of care.
LAccelerate experiments in methods of payment that
might better reward ``the right care at the right time.'' And
provide relief for federal/community partnerships where it
becomes clear that specific regulations impair patient outcomes
or efficient care delivery.
In exchange, individual healthcare institutions and communities
like ours are obligated to create the kind of learning network I have
described, to create regional healthcare delivery systems fundamentally
committed to and capable of performing at the highest levels.
The partners of PRHI are committed to this framework for change. We
are honored by your interest in our work. I look forward to your
questions and comments.
Chairman JOHNSON. Thank you. I thank the panel for their
thoughtful remarks.
I want to ask two questions. The first one is, some of you
have had very direct experience in creating what one of you
referred to as a culture of safety. Many of you mentioned
openness, transparency, that you have to be able to let people
and encourage people to say whatever is on their mind, if they
observed something they thought was odd, and so on and so
forth, so that there is free and open communication. What is
the relationship to creating that kind of system and also
having whistle-blower protection? Dr. Bagian?
Dr. BAGIAN. This is Jim Bagian.
Chairman JOHNSON. Am I saying that right?
Dr. BAGIAN. Bagian. That's fine.
Let me tell you experience we have had, you know, because
we have had to deal with this, certainly. The big issue is that
the care giver doesn't view it as punitive when they go to do
it, and we don't have whistle-blower protection per se, though
there is some that exists.
Within our system, if you submit data or there is data in
the safety or quality system, you may not divulge that to
anyone, and there actually is a criminal penalty of, I think it
is like a $10,000 fine and 6 months in jail, for disclosure of
anything in there. So people understand when they submit into
the quality system that it is to be used for quality and safety
improvement and nothing else. That has always been very clear,
and from a leadership standpoint we have always been very
aggressive to enforce that.
The other thing is, as I mentioned before, the whole
definition of getting people to even want to trust the system,
that they have to see it will do good. That is where we saw a
ramp-up over the first 10 months of the new system, that they
saw reports of the same type of incidents that had been
reported in the past. There is like nothing new under the sun,
pretty much. The problems that occur today have occurred for
eons, certainly decades.
When they saw the results were more systems-oriented, that
made a huge difference to the culture change, and that is why
we saw the dramatic increase in reporting and as far as actual
really meaningful solutions that actually prevented problems,
rather than just document problems, which really doesn't do
much at all. So I think it is people have to understand how it
will be used, and then you must demonstrate it, and leadership,
and I can't emphasize this enough.
One of the things we did is at every facility, the facility
chief executive officer has to actually concur or not concur
with each line item of a recommendation that a team--this is a
team of nurses, physicians, pharmacists--says this is what
needs to be done. If they nonconcur, they have to put in
writing, in the record, why they don't concur, and then it goes
back for revision, but they can't just say, ``I don't like to
do this.''
That has caused tremendous better communication within the
hospital in general, and actions taken, because where the
accountability, if there is any, resides, if you want to look
at it that way, is with the chief executive officer of the
hospital, that they take responsibility that these improvements
will be made. I think when people--and we have gotten reports
from the field that people can't believe that problems that
were dealt with in a punitive manner before actually are dealt
with in a constructive manner, that they actually see
improvement, and that kind of primes the pump and it builds on
itself.
Chairman JOHNSON. Thank you. Anyone else wish to comment?
Mary? Ms. Foley?
Ms. FOLEY. Yes, thank you. I think it is an excellent
question. I think it is consistent with the environment of both
the blame-free and the non-disciplinary approach. I mean, the
ultimate, not the ultimate sacrifice but a severe sacrifice for
someone who believes it is imperative for them to
professionally report an incident or a practitioner is the loss
of a job, and that indeed is what we are attempting to prevent
by passing the whistle-blower protection.
So, it is an extreme type of discipline or intervention
that really just puts a, casts a pall over people's belief that
it is the right thing, it is the necessary thing to do. It is
not the only approach. I think there are many levels of just
that stimulating the reporting in an environment in which it is
safe, that it is protected, that it is promoted. The whistle-
blower is an extension of that same type of protection for that
more severe action, and we see it connected because that whole
attitude, that there are costs to doing the right thing, has to
be eliminated or people will be repressed, and that is
unfortunate.
Chairman JOHNSON. Dr. Miller?
Dr. MILLER. I certainly agree with what has been said
already. I would just add that within an organization, often
you want to promote the culture of reporting but you also want
to make that easy to do, and it is not always so easy. It takes
time to report. The reporting can be confidential or not
confidential.
In terms of whistle-blower kinds of things, we certainly
have those things in place in our organization, but we actually
tie it to a little bit of what Dr. Bagian was talking about. If
someone wants to report an error, they can do it
confidentially, they can do it by phone, they can do it in
writing, but we have a policy that within 5 days we get back to
them.
Whoever, if they say who they were, we not only protect
them for reporting it and encourage it--and my report card
internally is to have more errors reported this year, not
fewer--but that we have an obligation to get back to whoever
blew that whistle, if you will, and tell them what our action
was. Sometimes there is no action that can be taken, but they
deserve a response, and I think that takes care a lot of the
disgruntled employee, or nurse or pharmacist or doctor that
says, you know, ``I can't bother complaining anymore. Either
they will go after me or they won't do anything about it
anyway.''
Dr. FEINSTEIN. Madam Chairman?
Chairman JOHNSON. Dr. Feinstein?
Dr. FEINSTEIN. Can I say one thing, too? I would de-
emphasize issues of whistle-blower protection and focus on
developing a positive reward system, with incentives that a
chief executive officer who is really committed to solving
problems and having an error-free environment would endorse.
Certainly that is something we learned when we observed Alcoa.
If there is a passion for this, if the person at the top says,
``This is a learning environment, we are here to learn, we are
not here to hurt anybody,'' it creates an environment and
culture that is so important to error reduction.
Anything that can be done to support that should be
encouraged. We do have an example of a hospital among all of
our hospitals who is doing the most reporting on medication
error. I would say it is the culture at the hospital and the
support of the chief executive officer that is bringing forth
so many errors. They report many times, multiple times the
number of errors that any other hospital does. They have the
same protections, and we have great belief in protections. They
have no more, no less than anyone else, but they have a chief
executive officer who really supports this.
Chairman JOHNSON. Dr. Berwick?
Dr. BERWICK. One quick word on that. If a system needs
whistle-blower protection, it isn't going to get safe, because
it means there is fear in the system. I think you should have
the protections, but don't expect--that is not culture change.
That is just good police work.
Let me explain for a second what happens in a hospital
where the culture change exists. You just get the other image
in your mind, is what Karen said. Take Luther-Middleford
Hospital in Eau Clare, Wisconsin, a great place. The chief
executive officer there did what Karen said, she said, ``We
can't be safe if we don't know what's going on. I will be
behind you. Tell us what's going on.'' Nursing reports of
injuries to patients went up 40fold within 3 months.
The local newspaper got hold of it and ran a headline, said
``Hospital Injuries Increase 40-Fold.'' They got it completely
wrong. All that happened was, it became a transparent system
and finally they could get to work on it. The courage it took
on the part of that executive and the board to do it, and then
to go to the community and say, ``No, let us explain what
happened,'' that is what culture change and leadership looks
like. So do whistle-blowers, but we are after a different
phenomenon in the industry, which is a different kind of
courage at the executive and board level.
Chairman JOHNSON. Thank you. I do think that leadership is
key, and nothing will happen without it, and no amount of law
or whistle-blower protection will change the culture if there
isn't leadership.
You might all think about, how can we hold the top
executive more accountable for that leadership, as opposed to
providing whistle-blower protection? Because in the end culture
change can't be done negatively, it has to be done positively.
Now, I separate this entirely in my mind, although I know
they're not entirely separate, from this issue of mandatory
overtime which I think is a very serious development in our
system, and will carry with it enormous potential for errors if
we don't do something about it. So, you know, I want to
recognize that, because I have had some terrible examples come
to my attention of the abuse of mandatory overtime. I think
nonetheless cultural change cannot be legislated from
Washington, so the question is, how do we change the way we
hold our systems accountable and look at you?
Then I want to just get back to this issue of cost. You
have given us some very good information about the initial
cost. It is clearly multi-million. Why is it that our capital
payment system isn't sufficient, or is it?
We no longer make you prove that you made capital
expenditures in order for us to give you capital payments.
There is sort of an automatic capital payment system now that
gives you money, assuming all of the kind of technology change
and the various things you have to do to upgrade your operating
rooms and so on. So, why isn't that sufficient to focus on this
issue, or is it? Dr. Miller?
Dr. MILLER. Unfortunately, it is not. I can give you an
example from Danbury. We do run in the black, and we have
dollars that are available for capital purchases every year,
and the price tag on those purchases, capital purchases or
renovations, goes up annually. Pharmacy costs are going up
double-digit annually. New technologies that we need to have in
order to provide quality care to our patients, I don't mean
something esoteric or to compete, I mean quality care for
patients, those things cost more money.
Very specifically, we talked about the dollars for
computerized physician order entry. A single example, one 371-
bed hospital. This fiscal year, our clinical leaders for
capital equipment purchase requests was $50 million. I had $20
million to spend. That means $30 million that was requested,
not for frivolous things but for replacement items,
renovations, fix this, the physical plants that weren't as
sturdy as they once were, they were built 25 years ago, new
technologies that a new surgeon wants in the operating room,
all those things cost money. I don't have enough money for this
year's requests. New technologies like physician order entry,
and I had to get the budget to approve that, meant there were
$2 million worth of things that I couldn't buy instead.
Chairman JOHNSON. Thank you very much. Dr. Berwick?
Dr. BERWICK. Thank you, Madam Chair. I want to divide the
capital question into several categories because it is not one
problem.
First problem, wiring physician offices. Five years from
now there is no reason in this country we should have
handwritten prescriptions. There is no reason any physician
shouldn't have access to a hospital medical record for one of
his patients. There is no reason we shouldn't have a master
drug list.
For an average doctor, it is a small amount of capital,
$10,000, $20,000 to get into that world, but a lot of physician
practices are having a lot of trouble getting there. We need
some solution. I think it should be a public default system
available to anyone, out of the VA or somewhere, where we just
say, ``You can have this if you want it. If you want something
better, you can invest in it.''
Second, small hospitals, small and rural. I don't know how
big Danbury is, but there is a whole--there are thousands of
hospitals that can't spend the $3 million it will take them to
get CPOE. We have got to help them out.
The third, the big systems I am frankly not worried about.
We have lots of investment going on, and big capital
investments in enormous multi-hospital systems, they are going
to make those investments. There is a little problem here on
return on investment, because once you get into the world of
safety and quality improvement, money is saved by the system
but it may well be lost to the hospital.
I was just in Bellingham, Washington, where the hospital is
supporting a community effort to improve diabetes care. They
know it is going to end up reducing their revenues by $2.5
million a year because diabetics aren't going to be in the
hospital, and it is a system saving that doesn't go to the
hospital. We have got to solve that problem. We have to get--
that is what payment for quality would look like, that creative
circumstance in which, when the money is harvested out of the
system, it goes back into the system in a more creative way.
The last issue is a cost-reduction thing. It is kind of how
could you reduce the cost of capital? The standardization
problem is very serious. Right now, investing capital for some
facilities is a very risky game, because they could capitalize
a system with one language and tomorrow we could end up with a
different language structure and they will have wasted a lot of
money or have a lot of adaptation to do.
That is why I think the safety issue is related to a
national move to say, ``Here are the standard languages. We
promise you this is going to be here. For laboratories it will
be Loink. For diagnoses it will be Snomed.'' Whatever we
decide, let's just make a decision and say to the Nation, ``Now
you can be safe in investing.''
Chairman JOHNSON. Just briefly, do we know enough to
establish a single standard language?
Dr. BERWICK. There are six standards we need, in my
opinion; four we do, two we don't.
Chairman JOHNSON. Okay.
Dr. BERWICK. Laboratories, everyone agrees that Loink is
the right system. If CMS said tomorrow, ``That's the system,
everyone code now or we won't pay your bills in 3 years,'' that
will get that solved.
For diagnoses I think Snomed is the right answer. It is
currently owned in a proprietary way, but negotiations are
underway for the government to make those public domain. We
should get that done. That has been going on 18 months. It
doesn't make any sense.
There is a system for dialog called HL7 which you have
invested in. It could be the national standard. Everyone kind
of agrees it is better than anything else.
There is the DICOM, the Digital Imaging and Communications
in Medicine system.
We don't know quite yet nationally how to code drugs,
medications, and we really need to. We need to have a standard
medications coding system in the country.
We don't know how to code procedures yet, although there
are several options. Within 6 months, if you told CMS, ``Let's
establish, let's have the backbone, let's say these are the
systems, they're not going to change,'' you will save millions
of capital for hospitals like Danbury, and we will get on with
the job. I think it will require Federal leadership. We don't
have another structure to get that job done.
Chairman JOHNSON. Thank you very much. I am going to turn
to Mr. Stark, and yield the Chair to Mr. Camp of Michigan.
Thank you.
Mr. STARK. Thank you, Madam Chair.
Let me just take one more crack here at EMTALA, the
Emergency Medical Treatment and Active Labor Act, and the
Patients' Bill of Rights bill, which has been passed in both
Houses, and a section which I think has no quarrel from either
side of the aisle or in either House. Is there anybody who
would object to either of those standards being used?
Now, the American Hospital Association has, but tell them
to get with it, Dr. Miller. I mean, I think we can find and
take care of that, and I think everybody understands that it is
the issue of the subordinate who reports to their supervisor,
who ignores them, and then the subordinate goes elsewhere.
Arguably that is not desirable, but it probably is more
desirable than having a subordinate who will suborn those
issues. I think we could get that one taken care of pretty
quickly.
The issue of capital and getting the system working just
may very well be a problem in the system. When you allow or
encourage, depending on what State you are in, a lot of
competition and oversupply, when you are running less than 60
percent of staff-bed occupancy, then you have got to say,
``Well, wait a minute.'' Or when you have got to make the case
that you want to buy a computer system for a 20-bed rural
hospital. It would probably cost almost as much as it would for
your hospital, Dr. Miller, but you have got 20 times more
people that you are serving.
That politically, you know, you can't get any of my
colleagues who want to close the hospital, as small as it may
be, on their watch. Nobody builds statues to us in our home
district for closing a hospital or a post office. So we have
got to find some way for the communities to get off stage, to
perhaps consolidate, to share equipment. I don't know, we
aren't going to be able to do that, and that is part, I think
has got to be part of this.
In the costing, one of the things that occurs to me is that
you all in the hospital business don't take your recalls. I
take my car in to get it tuned up and they do something, the
dealer has to fix it for free if they screwed up, right? I go
to the hospital and something happens subsequently, poor Blue
Cross has got to pay again to send me back.
Now, if we changed the system and you had to do your own
recalls, that is either a loss of revenue or an increase of
cost, you slice it either way you want, and I suppose you ought
to be compensated for that. I mean, I think if that is part of
what is having people drag their heels on this, and I don't
know whether they are so harsh that they are willing to say,
``We won't do it because it's going to cost us more to correct
our mistakes,'' I hope that people aren't thinking that way,
but they may. I think that would be a valid issue for us to
say, ``Okay, if we are creating more procedures, then we're
going to pay for it.''
We are going to have to come to that same issue, I suppose,
with pharmaceuticals. They are costing more. They are costing
you more on the one hand, and they are probably, if they do
what they say they are going to do, my Zocor, which is very
expensive, means you are less likely to get me into some heart
program where you make a lot of money on me.
The next thing is, what are we going to do about boutiques?
As we balkanize your hospital, so all the cardiologists in
Danbury say, ``Uh-uh, we're going to create our own heart
hospital,'' they are going to thumb their nose at you and pull
a lot of your good revenue, high-margin revenue, out.
All of these things face you. It doesn't happen in the
veterans' hospitals, I don't suppose, now, but I hope that you
will work with us to address that. I don't think it does us any
good. I mean, I think the balkanization thing hurts teaching
hospitals, in which I have a lot of faith, and managed care
plans, they aren't going to teaching hospitals if they can
avoid it because it costs them more.
I think that in this overall review of safety we have to
help you, but you have got to be willing to work with us. I
mean, we can't just say no, we are not going to have
regulation, because then we are not going to get a universal
computer language.
I mean, you have to be willing to trust us that we won't
impact too much, and we have to trust you that you are not
going to just come and hit us all the time for more capital.
When I will tell you, you ought to be thankful that Danbury is
not in California, because retrofitting California hospitals
for Earthquakes, we are looking at $8 or $9 billion. Our
hospitals, they are doing pretty well but not that well.
So, I mean, there is a shared responsibility here, and I
assure you that while some of us may be more skeptical than
others about absolute tort reform, I have no quarrel with the
idea of no-fault. I mean, I wrote the original bill for the
District of Columbia, and driving in this city with no-fault
auto insurance, and you would wonder about what we were doing
those many years ago. It can work, as long as you leave the
outlier for the gross negligence, because I think that threat
has a salutary effect on those chief executive officers who may
not just completely want to do this out of the goodness of
their heart.
So, thank you for being here. Please push us, because this,
we can talk this to death. There are some bills. Tell the
Hospital Association to give us their bill. I mean, the
Secretary can get to the drafters of legislation more quickly
than I can. Let Secretary O'Neill draft a bill for us and send
it over. I will introduce it for him, but we have got to get
going.
I mean, this process, we won't please everybody, so I will
just shut up and say that the secret is when all of you are
frowning, Ms. Foley, Dr. Miller, Dr. Berwick. Then we have got
the right bill. If anybody is smiling, somebody got away with
something. So let's get you all frowning, drop the gavel and
say, ``Go forward with a bill.'' I really hope we could do it.
Thank you very much.
Thank you.
Mr. CAMP. [Presiding.] Thank you. I just have a couple of
questions.
Dr. Berwick, you were the author of this groundbreaking
study on this issue which said that preventable medical errors
are the eighth leading cause of death in America, accounting
for as many as 98,000 mortalities in hospitals each year, and I
think this only gives us a window on hospital deaths and does
not really include the number of patients injured. Do you have
an estimate of the number of patients that are harmed or killed
as a result of medical errors in America each year?
Dr. BERWICK. I don't have it, nor does any such estimate
exist that I know of. The eighth leading cause of death figure
is attached to the estimate of 44,000. If it is 98,000, it is
the fourth leading cause of death, just hospital injuries. What
we do know is that certain forms of ambulatory surgery centers
are quite unsafe. We know there are injuries in nursing homes.
The other calculation that would be great to see would be
deaths and injuries due to quality failures beyond safety
hazards, for example, the failure to use the best-known
medication or the failure to use the proper diagnostic
procedure. That is not called an error in the errors report.
That is a different kind of failure, and my own estimate is
that there are many times that number of people who are
suffering unnecessarily because of quality failures as there
are of the more confined area of just errors.
Mr. CAMP. So, then how serious would you say this problem
is?
Dr. BERWICK. The biggest opportunity for improving the
health status of Americans, beyond prevention of disease, is to
improve the quality of health care.
Mr. CAMP. Dr. Feinstein, you mentioned that obviously if
Federal policy doesn't have quick fixes, in your testimony, and
relies less on mandates and punishment and more on what you
called learning networks, what would be the ideal components,
just to summarize, of an error reporting system?
Dr. FEINSTEIN. Well, error reporting systems and new
technologies are tools that become part of a general quality
and process improvement framework. I don't want to in any way
miss the opportunity to say that databases are very important.
Protections so that someone can enter data on problems, all
problems is critical. It is how Alcoa became the best in the
world. Even more important is to embed all of these into a
process improvement framework. This is what I would encourage
the Federal government to do. We need to create in health care
the same total safety environment that you have in aviation and
the nuclear power industry.
That involves research and education efforts directed at
understanding, for everybody involved in a health enterprise,
how to create a quality and a safety-focused environment.
Systems need to keep learning how to move continuously toward
improved safety, and more application of what we know to be
good practice. The partnerships we have had with CMS, AHRQ,
CDC, to date have helped us to build this improvement
framework, to understand what works, and also how you are
continually, as you introduce new technologies and as you
gather more data, you are continually coming up with new
problems.
Mr. CAMP. All right. You have mentioned that you believe
State peer review statutes are inadequate, and why do you think
that is so, and is that why you think we need a single national
standard?
Dr. FEINSTEIN. I will speak from our own example--our
Pennsylvania State peer review statutes are good. The Medicare
protections through our Quality Improvement Organization, QIO,
are very good, but involves only the Medicare population.
Hospitals are treating a very broad base of patients. We want
to learn from all our errors, all our problems. Every one is
significant, even the ones that are minor, even the ones that
don't hurt people.
Mr. CAMP. Thank you. The gentlewoman from Florida.
Ms. THURMAN. Thank you, Mr. Camp. I apologize for not being
here for all the testimony, but we have this little stimulus
package on the Floor today that we seem to all be concerned
about and want to see something done with.
Beyond that, I probably just want to get some ideas from
all of you. I don't know if you are familiar with a piece of
legislation that Mr. Houghton and I have introduced on
medication errors. It is actually--and it is being done by
Senator Graham from Florida and Olympia Snowe in Maine, and
there are a few differences but not much of a difference.
I am curious because we think, at least looking at the
numbers, medication errors seems to be a very high part of any
of this system that we are concerned about. Some of the numbers
we have seen, that there have been approximately 7,000 deaths,
some 250,000 nonfatal injuries. What I also find interesting
about it is that by doing some of this, and I think you all
have alluded to this, that because of this that it costs about
$4,700 per patient admission because of these issues.
So, we put a piece of legislation together specifically to
look at technology, the kinds of things we can do with
technology. Jim, I know that you all have done much of this at
the Michigan VA, and DOD has similar technology. I happen to
have had the experience of my mother being at Walter Reed. They
have a wonderful system going on out there. It is all
computerized. Doctors know what is going on. Everything goes
into the computer, the patient's information, what medicines
and all those kinds of things. I was fascinated by what had
happened out there, and certainly the VA hospital in
Gainesville and others have implemented some of that.
What we are trying to do is actually give about $1 billion
over a 10-year period of time to help hospitals and nursing
homes, because we think skilled nursing facilities have got to
be in this mix, and we also have taken a part of these dollars
and we have carved out about 20 percent of those dollars going
to rural health areas, because that too is something we think
is absolutely necessary.
Then we have actually tried to work on a board that would
be called the Medical Information Technology Advisory Board,
specifically because we also think that as we get this
information, as we are using with the patients, as it is
working, we also know that we want to be able to transmit this
information so in case somebody needs the information for
follow-up on somebody. We also recognize there is information,
privacy issues come up, privacy issues that become a concern,
and so the difference between Senator Graham's and our bill
basically is that issue.
There will be some criticism of this bill because funding
comes out of the Medicare Trust Fund. I don't want that to be
where it comes. That just seems right now the best place that
we can look for the dollars. We think it is a good investment,
potentially saves money, and certainly would like to work with
any of you on this issue. Certainly, based on your comments,
there is not money in these hospitals. There is not anything to
be able to be done with capital improvements. That is going to
create a problem.
Just based on my explanation of what we have done here, can
you give me a little bit of feedback on whether you think that
this might be something that could work, would be helpful, and
what we can do to get this moving?
Dr. BERWICK. I will start. I am sorry, I was aware of it as
the Graham-Snowe bill. I think it is a good idea. I think it
would at least get some acceleration into the system.
Here are two ideas. One is, continue as you are to make
sure the money goes where the need is. Industry ought to be
obligated to obligate capital to this when it can afford it. So
as long as you are targeting rural, small areas, hospitals that
are in underserved communities, I am happier that we are not
offering money where it won't make a difference.
The second is an idea I have got. I have no way to know how
to put it in the legislation, but I think it is a good idea.
Why reinvent the wheel over and over and over again for a
thousand rural hospitals, or if you want to go to physician
offices, for 20,000 physician offices?
Could it be a government task to fund and create a single
national default option which is available at extremely low
cost as the basic system, so we could say to rural hospitals or
to physicians' offices, ``You can have this one. The VA built
it. They put the money in. It's your money. It's your tax
dollars.'' Or if not VA, someone else. ``It's yours. You can
have it for free. If you want to buy something with higher end
or higher functionality, of course feel free to invest money
further.''
No one is going to do that, and it would really accelerate
the action a lot. We have spent public dollars on wonderful
systems that, with some adjustment and some investment, perhaps
under your legislation, could become a national gift, I guess,
to the system that is having trouble getting over this capital
threshold. It would save in aggregate nationally lots of money,
because then we won't have a thousand places doing a thousand
different things. We will have one system that everyone can
use.
Mr. CAMP. Just quickly, we do have a recorded vote with 8
minutes left, so if you could just quickly sum up.
Dr. MILLER. A couple of quick points. I am interested in
the legislation. I don't know all of its details. I am a little
anxious about designation of dollars more to rural hospitals. I
would want to make sure we are putting the dollars where they
need to be.
Ms. THURMAN. It is 20 percent. It just carves it out of 20
percent, so they don't get left out of the system.
Dr. MILLER. They shouldn't be, but the middle-size
community hospital is often the one that should have more
complicated systems in place, because it is big enough and may
not have the resources.
The source of dollars is always problematic. We talked
earlier aboutsources. Taking it out of Medicare funds is just
going to take it out of one pocket and put it in the other. It
is not going to solve my problem.
The third, I will be brief, but it is an issue. The whole
business of cost savings with new technologies, I believe in
it, I believe in that $4,000 figure. I have read the studies. I
think those savings are way down the line, and they are
illusive. The Advisory Board has published four stars for
quality for physician order entry, and that is why we should do
it; one star for cost savings. That will be hard to achieve.
Ms. FOLEY. I will sum very quickly, as well. Thank you. I
haven't looked at the bill, but it sounds good, because the
most difficult position that good administrators are put in is
to choose where to spend their money. If they have to choose
between technology and adequate staff, that is a terrible
position to put good people in, so additional incentives for
the pursuit of the technology while we also provide the
adequate funding for the people.
The U.S. Pharcacopeia, USP, study showed that primary
contributing factors to medication errors were distractions and
work load increases. So, though we know there are some savings
and error prevention to be achieved, we don't want to just go
off in one direction. That is why that system approach, which
is what we are all about, is very good. It sounds very
exciting. Thank you.
Ms. THURMAN. Thank you all very much.
Mr. CAMP. All right. I want to thank you all for your very
helpful testimony, and this Health Subcommittee hearing on
health quality and medical errors is now adjourned.
[Whereupon, at 12:31 p.m., the hearing was adjourned.]
[Submissions for the record follow:]
Statement of the American Academy of Family Physicians, Leawood, Kansas
Introduction
This statement, submitted to the Ways and Means Health Subcommittee
regarding patient safety and health care quality is offered on behalf
of the 93,500 members of the American Academy of Family Physicians
(AAFP).
The Academy Finds the Creation of a Non-Punitive Environment a Mandate
for Safety Reporting
The Institute of Medicine's report, To Err is Human, released in
December 1999, highlighted the unacceptable frequency of health care
errors. All patients need to know they can rely on their physicians to
do the utmost to bring about the best possible medical outcome. Such
assurance requires that patients are as free as possible from harm due
to medical errors, regardless of the setting. Unfortunately, the IOM
study makes clear that adverse events occur with unacceptable
frequency. It is timely and appropriate for this aspect of quality in
the delivery of health care to become the focus of nationwide attention
and efforts for improvement. Today's hearing focuses on how Congress
can help initiate a patient safety reporting system to promote quality
health care.
In the US, most healthcare contacts are made in office settings;
most office-based care is primary healthcare; and family physicians
provide more primary healthcare than any other specialty. In 1998 in
the US, there were 39 million hospital discharges and 829 million
outpatient visits, suggesting that ambulatory care may hold an even
more important opportunity for improving patient safety. A recent study
of the ecology of medical care confirms this large, relative difference
in exposure to outpatient and inpatient care. This study, based on data
from the Medical Expenditure Panel Survey (a nationally representative,
longitudinal survey sponsored by the Agency for Healthcare Research and
Quality), found that for every one thousand patients in a month, 217
would be seen for a medical condition in the outpatient setting and
only eight to nine individuals would be hospitalized.
Three years ago, the AAFP made a $13 million commitment to
improving the research infrastructure for primary care ($7.7 million
for three Centers, and $5.3 million for the Robert Graham Center for
Policy Studies in Family Practice and Primary Care). In the last year,
that investment contributed the first US study of errors in ambulatory
care. The Robert Graham Center and the AAFP National Research Network
learned from 43 practices across this country what physician-reported
errors look like. These findings are currently in peer-review at the
international journal, Quality and Safety in Health Care. The Academy
recently launched a six-country study to look at errors in similar
clinical settings in the U.S., New Zealand, Canada, the Netherlands,
Australia and England so that patient safety and quality improvement
projects could benefit from comparison with other countries.
The Academy has been awarded an innovation grant from the Agency
for Healthcare Research and Quality (AHRQ) to develop a Center of
Excellence that will identify, test, and disseminate strategies for
making primary health care safer. One strategy already in use is a
computer web-based anonymous error reporting system that has so far
proved effective not only in identifying threats to patient safety but
also in improving more general aspects of primary health care quality.
The success of the Academy's error reporting system beyond initial
testing stages will depend upon Congressional efforts to ensure that
information reported remains confidential, is protected from use in
legal actions and will not be used in separate punitive actions as a
result of a report having been filed.
Finally, the Academy believes that there is a need for error-
reporting systems that are ``open, discussible and without blame,'' in
the words of Dr. Donald Berwick, one of the IOM study authors, and an
invited guest of the Subcommittee. Only by researching the underlying
cause of medical errors, creating effective interventions and
addressing future prevention, can the IOM's call for a 50 percent
reduction in the rate of medical errors over the next five years be
realized.
Additional Principles That Need to Be Incorporated into Patient Safety
Legislation
The Academy supports the following principles as integral to
creating a learning culture that actively seeks to improve the delivery
of health care.
Analysis and Feedback
Reporting systems cannot become warehouses of data. Information
submitted to reporting systems must be the basis for conducting
analysis that results in changes being made to practice. When effective
procedures are developed to respond to the underlying cause of patient
safety events, they should be compiled and widely
disseminated to all healthcare professionals and organizations.Confiden
tiality
Confidentiality protections are absolutely necessary for both
healthcare professionals and healthcare organizations to trust that
reported information will not be used in a punitive fashion. Without
such an assurance, individuals will continue to make independent
assessments about the utility of reporting their observations to
outside entities. Reporting systems should protect the identity of
individual patients and abide by all relevant confidentiality laws and
regulations. The identities of healthcare professionals and
organizations involved in errors should not be disclosed outside a
reporting system without consent. This vital protection ensures that
reporting systems, such as the ground-breaking system developed by the
Academy, have a far greater likelihood of being successful facilitators
for improving patient safety.
Information Sharing
While maintaining the confidentiality measures highlighted above,
sharing information is fundamental to a reporting system's ability to
achieve widespread improvements in patient safety and to instill a
confidence in the public that safety issues are being addressed. The
causes of errors and their solutions must be widely shared so that all
healthcare organizations can learn from the experiences of others.
Legal Status of Reporting System Information
Congress should create new federal protections for information
submitted to patient safety reporting systems. Informationdeveloped in
connection with reporting systems should be privileged for purposes of
federal and state judicial proceedings in civil matters, and for
purposes of federal and state administrative proceedings, including
with respect to discovery, subpoenas, testimony, or any other form of
disclosure. This new privilege should not interfere with the
availability of records that would be otherwise attainable, including
patient access to their own medical record.
Conclusion
The Academy appreciates this opportunity to submit a statement to
the subcommittee and looks forward to working with Congress to develop
effective patient safety legislation. This is a matter of continued
interest to AAFP and we thank the Ways and Means Health Subcommittee
for its interest in the topic.
Statement of the American Academy of Orthopaedic Surgeons
The American Academy of Orthopaedic Surgeons (AAOS), representing
18,000 board-certified orthopaedic surgeons, appreciates Chairman
Johnson's efforts to hold a hearing to address health quality and
patient safety. AAOS has long supported initiatives to reduce medical
errors and improve the quality of health care not only for Medicare
patients, but for all health care recipients.
AAOS shares the concerns of the Subcommittee on Health that medical
adverse events must be decreased, especially in light of the recent
report by the Institute of Medicine: To Err is Human: Building a Safer
Health System. We agree that there is a need to create a culture of
safety in reporting, and that we must embrace efforts that continuously
strive to improve the quality of patient care.
AAOS has designated the elimination of medical errors as a high
priority in our policies and practices, and, as a result, has committed
significant financial and clinical resources to educate our members in
the practice of safe care. We are pleased to share highlights of our
work over the past several years to reduce or eliminate specific types
of surgical errors.
In 1997, we launched the ``Sign Your Site'' initiative, an
education program that urges surgeons of all surgical specialties to
mark the operative site, in consultation with the patient, as part of
their pre-surgery routine. This protocol has the overwhelming support
of our members, who believe this program will prevent wrong-site
surgery. Numerous hospitals throughout the country have responded
positively to this campaign, and mandatory ``Sign Your Site'' programs
have been initiated at an increasing number of hospitals. AAOS supports
the ``Sign Your Site'' initiative as a required protocol for every
hospital seeking certification by the Joint Commission on the
Accreditation of Healthcare Organizations (JCAHO). We also believe that
a unified effort among surgeons, hospitals and other health care
providers to initiate pre-operative and other procedures will help to
prevent surgical error.
Since 1990, the AAOS Committee on Professional Liability has
conducted a series of closed-claim professional liability insurance
studies, through on-site retrospective review of the records of
insurance companies across the country, in order to assist orthopaedic
surgeons in providing optimum patient care. Several orthopaedic
diagnoses and procedures have been reviewed, including foot and ankle
surgery, spine surgery and spine fusion, total hip and knee
replacement, knee arthroscopy, fractures of the hip, femur and tibia,
and pediatric problems, and have resulted in the publication of two
books and numerous articles that have identified trends in unexpected
outcomes and medical errors and provided risk management. From these
studies, we have been able to establish or clarify appropriate
treatment protocols and methods of operation, enabling us to promote
safe and appropriate surgical practice. This guidance emphasizes
thorough patient consent discussions about treatment options and
alternatives, risks of treatment, non-treatment, and patient
expectations regarding eventual functional ability after treatment.
The AAOS Board of Directors recently created a ``Patient Safety
Committee'' within the organization to promote safe practices and to
reduce and prevent adverse events that could occur in orthopaedic
practice. This permanent committee will undertake several initiatives
over the next few years to enhance member and patient knowledge about
safe medical practices. A few of the Committee's goals include the
development of educational programs and communication publications that
will alert our members to potential medical product and drug
interaction complications; development of a curriculum on patient
safety for adoption into residency and fellowship programs; and
development of working relationships with other professional societies
and federal agencies that will focus on community based and national
collaborative initiatives for implementation of patient safety
improvements. A major charge to the Committee will be the continued
education of AAOS members to achieve a culture of safety within their
practice and to incorporate patient safety considerations into practice
guidelines.
AAOS also remains a recognized leader in the process of Continuous
Quality Improvement (CQI), an important cornerstone of our strategic
plan that helps us provide ``Best Care'' to our patients. We have
developed a comprehensive patient education program that will empower
patients by encouraging them to take control of managing their own
health care and increased communications to the public about the AAOS'
own commitment to this effort. The AAOS Committee on Evidence Based
Medicine remains focused on developing clinical practice guidelines and
performance measures to improve quality and efficiency of care, which
can be used to assist physicians in diagnosis and treatment decisions.
In addition to our internal education efforts, we continue to look
beyond our own organization to work with Federal agencies and other
health care organizations that support efforts to reduce medical
errors. The Department of Health and Human Services' Agency for
Healthcare Research and Quality (AHRQ) dedicated itself under the
leadership of Director John Eisenberg, MD, to conduct and disseminate
research in order to improve the outcomes, quality, access, cost and
utilization of health care services. We have maintained a dialogue with
key AHRQ staff to continue to provide input into their research efforts
and medical error projects, and AAOS Fellows have participated in
discussions surrounding the formation of a key AHRQ initiative, the
Patient Safety Task Force. This Task Force has begun to evaluate and
explore ways to minimize the burden of reporting adverse events and
errors and to explore the development of a single, coordinated system
for collecting data that would be easy to use and would provide
reliable, valid information.
We are active participants in the National Quality Forum (NQF), a
not-for-profit public-private membership organization established to
develop and implement a national strategy for health care quality
measurement and reporting. AAOS remains committed to participating in
the Ambulatory Surgical Care Consensus Project of the National Patient
Safety Foundation, a broad-based partnership of health care clinicians,
consumer advocates, health product manufacturers, public and private
employers and payers, researchers, regulators, and policymakers.
AAOS, as part of a large group of national health care
organizations, developed a set of key principles and safeguards that we
believe should be incorporated into voluntary patient safety reporting
systems.
These principles call for: the creation of a non-punitive
environment for safety reporting that focuses on preventing and
correcting systems as opposed to laying blame on individuals or
organizations, a comprehensive analysis of data to identify where
improvements can be made and new protocols should be developed,
assurance of confidentiality protections for patients, healthcare
professionals and organizations, the ability to disseminate and share
patient safety information to facilitate positive improvements, and
federal protection for reporting system information. We believe it is
critical that data collected and shared for the purposes of improving
patient safety be privileged, or use of patient safety reporting
systems may ultimately be discouraged. (Please see attached listing of
principles.)
As the Subcommittee evaluates appropriate responses to prevent
patient harm and minimize health systems errors, policies should
encourage a constructive partnership between the federal government,
hospitals, physicians, and other medical providers and personnel. These
public and private initiatives should be encouraged through a non-
punitive, cooperative environment, and should take a system-wide
approach that ensures patient confidentiality and appropriate legal
protection of all information involved in patient safety reporting
systems. Before instituting new reporting systems, AAOS encourages
federal and state governments to determine through initial,
scientifically sound research whether and how existing reporting
programs have led to a reduction in medical errors.
AAOS thanks Chairman Johnson, and the members of the Subcommittee
for holding this important hearing. We stand ready to work with the
Subcommittee and other Members of Congress to ensure safe practices in
our health care system.
______
General Principles for Patient Safety Reporting Systems
1. Creating an Environment for Safety. There should be a
nonpunitive culture for reporting healthcare errors that focuses on
preventing and correcting systems failures and not on individual or
organization culpability.
LHealthcare professionals and organizations should
foster a positive atmosphere that encourages the submission of
healthcare error reports to public or private oversight
organizations, accrediting bodies, an official compendial body,
or other generally recognized patient safety reporting systems.
The existence of a reporting system does not relieve healthcare
professionals and organizations of their responsibility to
maintain professionally recognized standards of care.
2. Data Analysis. Information submitted to reporting systems must
be comprehensively analyzed to identify actions that would minimize the
risk that reported events recur.
LSystems within organizations should be scrutinized
to identify weaknesses and processes that make healthcare
errors possible or likely to occur, and to identify actions to
prevent future errors. Effective procedures and/or protocols
developed through reporting systems should be compiled and
widely disseminated to all healthcare professionals and
organizations.
3. Confidentiality. Confidentiality protections for patients,
healthcare professionals, and healthcare organizations are essential to
the ability of any reporting system to learn about errors and effect
their reduction.
LReporting systems should protect the identity of
individual patients and abide by all relevant confidentiality
laws and regulations. The identities of healthcare
professionals and organizations involved in errors should not
be disclosed outside a reporting system without consent.
4. Information Sharing. Reporting systems should facilitate the
sharing of patient safety information among healthcare organizations
and foster confidential collaboration with other healthcare reporting
systems.
LSharing information is fundamental to a reporting
system's ability to achieve widespread improvements in patient
safety and to instill a confidence in the public that safety
issues are being addressed. Sharing of error-related
information is subject to the confidentiality principle.
LThe causes of errors and their solutions must be
widely shared so that all healthcare organizations can learn
from the experiences of others.
LIn some circumstances, it will be desirable to
share reports of errors among reporting systems, and with other
appropriate quality improvement entities, in order to
accomplish root cause analyses, to construct action plans, and
to engage in other efforts to enhance patient safety.
5. Legal Status of Reporting System Information. The absence of
federal protection for information submitted to patient safety
reporting systems discourages the use of such systems, which reduces
the opportunity to identify trends and implement corrective measures.
Information developed in connection with reporting systems should be
privileged for purposes of federal and state judicial proceedings in
civil matters, and for purposes of federal and state administrative
proceedings, including with respect to discovery, subpoenas, testimony,
or any other form of disclosure.
(a) Scope. The privilege for the information prepared for a
reporting system should extend to any data, report, memorandum,
analysis, statement, or other communication developed for the
purposes of the system. This privilege should not interfere
with the disclosure of information that is otherwise available,
including the right of individuals to access their own medical
records.
(b) No Waiver. The submission of healthcare error information
to a reporting system, or the sharing of information by
healthcare organizations or reporting systems with third
parties in accordance with these principles, should not be
construed as waiving this privilege or any other privilege
under federal or state law that exists with respect to the
information.
(c) Freedom of Information Act. Healthcare error information
received by and from reporting systems should be exempt from
the Freedom of Information Act and other similar state laws.
Such an exemption is necessary to preserve the privilege
discussed in this principle.
(d) Impact on State Law. A federal law is necessary to assure
protection of information submitted to national reporting
systems, but the federal protection should not preempt state
evidentiary laws that provide greater protection than federal
law. Providing such information to reporting systems should not
constitute a waiver of any state law privilege.
Statement of the American Academy of Pediatrics
The American Academy of Pediatrics is pleased to provide a
statement to the Subcommittee on Health of the Committee on Ways and
Means on issues of great importance to pediatricians--Health Quality
and Medical Errors.
Pediatricians provide the highest quality care to infants,
children, and adolescents but the Academy acknowledges that there are
opportunities for improvement. Our goal is to minimize errors and
maximize quality. The June 2001 policy of the Academy ``Principles of
Patient Safety in Pediatrics'' provides direction on setting up
processes to identify and learn from errors, developing performance
standards and expectations for safety, and promoting leadership and
knowledge (attached).
Patient safety may be broadly defined as including medication use
(medication errors and adverse drug events [ADEs]), wrong or delayed
diagnosis, surgical errors, birth injury or nosocomial infection.
Infants and children are at increased risk for harm because of their
limited reserves and the increased opportunities for error entailed by
weight-based dosing for virtually all pediatric medications. Because
there is very little published research about pediatric patient safety
issues, it is imperative that the Agency establishes a specific
research agenda focusing on patient safety issues in the pediatric
population.
Background: Medication Errors in Pediatrics
An important component of patient safety is medication error. The
Institute of Medicine report, ``To Err is Human,'' suggests that
medication errors are the most frequent type of patient safety error.
Little research has addressed the problem of medication errors and
adverse drug events in pediatric settings. The lack of pediatric
studies is unfortunate because children pose unique challenges,
including increased opportunities for error entailed by weight-based
dosing for virtually all medications, and the potential for more
serious consequences of drug errors due to the limited reserves of
smaller children.
Hospital Settings for Pediatric Care
In a study of complex errors in hospital prescribing, one
researcher demonstrated that the likelihood of drug error is an
exponential function of the number of drugs administered. A
hospitalized pediatric patient receives an average of seven
medications. The errors most frequently recognized in association with
hospital pediatric drug therapy include computation errors of dosage
and dosing interval, errors in drug orders (including written
instructions and interpretation), and errors in drug preparation or
conflicts with prescribed dosages. Children are at particular risk for
these types of errors, as the broad range of patient age and size
requires dosage individualization, most often using dosage equations.
Drug dosages for children are calculated on a per weight basis that
is significantly different from calculating dosages for adults. A
computation error can result in a significant under or over-dosage. One
medication safety issue especially harmful in pediatrics is commonly
referred to as the `ten-fold' error (e.g., a misplaced decimal point
can mean a ten-fold change in the appropriate dosage of medication).
One example dramatically illustrates this type of error. Jose Eric
Martinez was an ill two-month-old who exhibited early signs of
congestive heart failure. In order to ameliorate his condition, the
physician ordered intravenous Digoxin over aseveral day stay. However,
because of a decimal point error in determining the appropriate dosage,
the infant was given a dose that was 10 times what was intended and
died.
In order to better structure appropriate interventions, it is
critical to understand which pediatric age groups experience adverse
events most frequently. The Harvard Risk Management Foundation, with
significant experience in children's hospital settings, suggests that
there may be particular drug distribution and administration challenges
in patients weighing less than 5 kilograms (personal communication,
Frank Federico). Research is needed to confirm these findings and to
support the development of interventions that focus on clinical
decision-making and the use of alternate medications to improve care
and decrease errors.
In the only study documenting the epidemiology of medication errors
in a children's hospital setting, Rainu Kaushal, MD and her colleagues
found that serious pediatric medication errors (potential adverse drug
events and preventable adverse drug events) occurred at a three-fold
higher rate than in adults. This study provided important confirmation
of the unique epidemiology of medication errors in pediatric inpatient
populations and suggests that hospitalized children are at a greater
risk of serious medication errors than adults are. This finding gives
additional emphasis to the need for study of appropriate interventions
in the pediatric population.
In a review characterizing the nature and potential consequences of
actual prescribing errors involving dosage equations at a tertiary care
hospital, Timothy Lesar, PharmD, discovered that errors most commonly
involved children (69.5%) and antibiotics (53.5%). Forty-two percent of
errors were considered to put the patient at risk for serious or
preventable adverse outcome. Errors in decimal point placement,
mathematical calculation, or expression of dosage regimen accounted for
59.5% of dosage errors. Moreover, the dosage equation was wrong in
29.5% of dosage errors. The study analyzed the characteristics of 200
consecutive prescribing errors with potentially adverse outcomes
involving dosage equations.
In addition, research is needed to ensure the safe administration
of intravenous medications in the inpatient setting. Because the
administration of intravenous medications in a pediatric patient often
necessitates the use of a precise delivery system (e.g., an electronic
pump), this technology presents both an additional opportunity for
error as well as a potential safety check. Research could help
determine whether partnership with industry to improve pediatric
medication usage (e.g. explicit labeling for pediatric safety/dosing,
small volume infusion devices, etc.) can help reduce the rate of
medication errors for infants and children.
Because children depend on others to advocate for them, research on
the role families play in reducing medical errors in inpatient settings
would also be useful.
In the only published evaluation of an intervention to improve
safety in hospitalized children, Folli and colleagues demonstrated that
a pharmacy review of medication orders could prevent erroneous orders
from being implemented at a rate of 14-18 per 1000 patients days. Dr.
Kaushal and his colleagues are presently evaluating two other
interventions to reduce serious medication errors in pediatrics:
computerized physician order entry and clinical ward-based pharmacists
with continuous quality improvement teams.
Ambulatory Settings for Pediatric Care
With ambulatory settings providing an increasing proportion of
care, patients in inpatient care settings represent only a small part
of the population at risk for ADEs. It is estimated that 70 percent of
pediatric care takes places in ambulatory settings. This involves well-
child, acute, and chronic illness care. Furthermore, although prior
studies in adult outpatient populations have demonstrated that ADEs are
common, costly, expensive and often serious or fatal, what is known
about the prevalence and type of medication errors in pediatric
ambulatory settings is extremely limited.
Pediatricians in ambulatory settings prescribe medications in more
than half of patient encounters. In a recent survey of a random sample
of 1,600 of its members, researchers at the American Academy of
Pediatrics found that prescriptions are written for 52.9% of the
patients a pediatrician sees during an average workweek. Among those
prescriptions, 73.2% are for short-term acute illnesses and 29.2% are
for chronic long-term illnesses. Data from National Ambulatory Care
Medical Surveys (NACMS) also support this claim. Between 1993 and 1998
the number of office visits where a medication was ordered or provided
increased 13.8%, from 109.1 million to 124. 3 million. These data
illustrate the opportunity for medication error in children seen in
ambulatory settings, yet no research has been conducted to identify
common errors, develop a feasible system to report errors, or better
understand practices to decrease error in these settings.
Home health care settings also pose additional challenges. Not only
are there opportunities for errors in the intravenous administration of
medications (e.g., prepackaged medications, preparing and disposing of
syringes) but also in the management of children on ventilators and
other forms of medical equipment. As in other ambulatory settings,
little or no research has been conducted to identify and analyze the
types of medical errors in pediatric home care settings. This is
critical research given the interest in containing healthcare costs
through early discharge to the home.
Types of errors occurring in pediatric ambulatory or home health
care settings may include errors in physician drug prescribing (e.g.
wrong dose, wrong medication, wrong route, prescribing a medication
despite a known allergy, etc), pharmacy dispensing, and parental
administration. Outpatient drug complications, which can be a result of
a medication error, are not well studied in either adults or children.
In a study by Tejal Gandhi, MD and colleagues of adult patients
followed in urban clinics, drug complications in the ambulatory setting
were common, although most were not documented in the medical record.
No studies have been done to evaluate adverse drug events in pediatric
ambulatory settings. It is imperative that epidemiologic studies
document the type, frequency, and severity of errors in pediatric
ambulatory settings.
Significant numbers of medications are given to children every day
in schools, pre-schools and many child daycare settings. In fact, after
the home, schools and preschools are the most common locations for
medication administration to children to occur. Systems of medication
delivery at such institutions are too often sub-optimal or do not exist
at all. The presence of school nurses increases the likelihood that a
school district has a medication-delivery and recording protocol;
however, the presence of school nurses is highly variable. In addition,
childcare settings for infants and toddlers rarely have any support for
health matters and little monitoring by the state agencies. Research on
errors in these settings should be a priority. In addition, research is
needed to design, promote, and implement standardized protocols for
medication delivery in schools, preschools, child care centers, and
family-based child day care homes.
Information Technology
Information technology has great potential to minimize medication
errors. Computerized order entry has been shown to decrease errors. In
addition, this technology offers the opportunity to coordinate care
given by multiple individuals to a single pediatric patient. It is
imperative that research examine the many uses of information
technology in improving patient safety as well as how to influence
clinician acceptance of information technology in both the ambulatory
and inpatient settings.
Safe and Appropriate Use of Medications in Children
The safety of medication use in the pediatric population represents
an important area of research need. This knowledge could minimize the
risk and maximize the quality of care that children receive. The
following are important topics for research:
Psychotropic drug use in children.
To determine the prevalence of psychotropic medication use in
preschool-aged children, JM Zito, MD and colleagues analyzed ambulatory
care prescription records from two state Medicaid programs and a
salaried group model health maintenance organization (HMO). It was
discovered that the number of psychotropic medications prescribed for
preschoolers increased dramatically from 1991 to 1995. The use of
stimulants, the most common class of drugs prescribed, increased three-
fold in this age group during the early 1990s. These findings are
especially remarkable due to the limited data on the efficacy and
safety of psychotropic medication use in children. Epidemiologic
studies are needed to evaluate clinical and treatment outcomes.
Clinical trials are necessary to evaluate dosages, efficacy, and safety
of certain drugs not approved for a pediatric age group.
Inappropriate use/overuse of antibiotics for otitis media (ear
infections).
Antimicrobials are the second leading therapeutic category of drugs
prescribed by office-based physicians in the United States each year.
According to the 1996 NACMS, antibiotic prescriptions reached 128
millions doses compared to 86 million in 1980. From 1990 to 1992,
almost one in six physician office visits resulted in antimicrobial
prescription. In 1992, more than 6.5 million prescriptions were written
for children with a cold or upper respiratory infection.
Otitis media is the leading indication for outpatient antimicrobial
use in the United States. Overdiagnosis of and unnecessary prescribing
for otitis media has contributed to the spread of antimicrobial
resistance. In a recent prospective study, antimicrobial treatment of
otitis media accounted for more than 90% of all antimicrobial use
during the first two years of life. These data again underscore the
increased risk children's health and safety when they are needlessly
exposed to drugs.Research is needed to help physicians better identify
which children need antimicrobials, and how to most effectively change
clinicians' prescribing behavior for otitis media. Studies also have
demonstrated that parents influence the physician's decision to
prescribe antimicrobials. Based on this fact, it is essential that
research identify effective approaches to change parents' expectations
about the indications for antibiotics as well as how to improve
physician-parent communication on this topic.
Reporting Systems
Based on the recommendations in the IOM report, state and national
policy makers have begun to examine the role reporting systems play in
reducing medical errors. However, there are significant external
barriers to implementing effective reporting systems. The blame and
punish philosophy and the search for individual culpability still
persists. This is an obstacle to openly discussing or reporting errors.
Reporting programs should be aimed at ensuring that health systems are
safe for children. To do so, the reporting systems should be non-
punitive, ensure anonymity, focus on system failures, recognize that
adverse events may or may not be caused by errors, and support the key
role that organizational leadership plays in systems improvement.
To promote effective reporting systems that are designed to
maximize patient safety, the Academy recommends AHRQ support research
that will provide information to guide decision-making on the following
issues:
LUnderstanding the relationship between
organizational culture and reductions in medical error,
specifically contrasting punitive versus non-punitive
environments and different institutional approaches to creating
cultures of safety in pediatrics.
LDetermining the effectiveness of interdisciplinary
safety teams with leadership sanctions in improving either
rates of medical error reporting or changes in patient care
systems.
LExamining the effectiveness of state reporting
systems on reducing medical errors in pediatrics, including
determining whether states that require mandatory board reports
with disciplinary action have lower rates of medical error
reporting.
LExploring whether active error identification
systems improve the yield of reported medication errors
Ascertaining whether signal/trigger systems are as effective as
spontaneous reporting systems for medication error.
LExploring best ways to encourage reporting.
Defining the impact of the error debate on families'
satisfaction with health services.
Summary
In summary, the American Academy of Pediatrics urges the Congress
to work with the medical community to address the following patient
safety issues in the pediatric community:
LTesting and refining the methods for determining
medication error, potential adverse drug effects, potential
adverse drug effects, and adverse drug detection and analysis
in both in-patient and ambulatory settings.
LDocumenting the epidemiology of pediatric
medication errors in both inpatient and ambulatory settings as
a major step towards designing interventions to intercept
errors and prevent ADEs in children.
LDocumenting the epidemiology of pediatric
medication errors in childcare and school settings.
LDeveloping and testing interventions to improve
medication systems in both inpatient and ambulatory settings.
LDesigning, promoting, and implementing standardized
protocols for medication delivery in schools, preschools,
childcare centers, and family-based child day care homes.
LDeveloping and testing effective reporting systems.
Researching how to influence clinician acceptance of
computerized order entry systems in both the ambulatory and
inpatient settings.
LStudying the use of computer technologies as tools
to minimize drug errors or as aids in coordinating care
provided by multiple individuals.
REFERENCES AVAILABLE UPON REQUEST.
Attachment: Principles of Patient Safety in Pediatrics, AAP Policy
statement:
__________
Policy Statement
Pediatrics
Volume 107, Number 6
June 2001, pp. 1473-1475
Principles of Patient Safety in Pediatrics (RE060027)
AMERICAN ACADEMY OF PEDIATRICS
National Initiative for Children's Health Care Quality Project
Advisory Committee
ABSTRACT. The American Academy of Pediatrics and its members are
committed to improving the health care system to provide the best and
safest health care for infants, children, adolescents, and young
adults. In response to a 1999 Institute of Medicine report on building
a safer health system, a set of principles was established to guide the
profession in designing a health care system that maximizes quality of
care and minimizes medical errors through identification and
resolution. This set of principles provides direction on setting up
processes to identify and learn from errors, developing performance
standards and expectations for safety, and promoting leadership and
knowledge.
INTRODUCTION
The 1999 report of the Institute of Medicine, To Err Is Human:
Building a Safer Health System, notes that errors in health care are a
leading cause of death and injury.\1\ Between 3% and 4% of hospitalized
patients are harmed by the care that is supposed to help them. On
average, of 100 hospitalized patients, 7 are exposed to a serious
medication error that harms or could have harmed them. It is estimated
that between 44,000 and 98,000 Americans die in hospitals each year as
a result of errors in their care.\2\ Although these figures have been
challenged, there is no disagreement as to the importance of the topic
or the existence of substantial safety concerns in health care. In
response to the report, Congress and various states are proposing
legislation and programs to improve patient safety.
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\1\ Committee on Quality Health Care in America, Institute of
Medicine. In: Kohn LT, Corrigan JM, Donaldson MS, eds. To Err Is Human:
Building a Safer Health System. Washington, DC: Institute of Medicine;
1999.
\2\ Hearings before the Subcommittee on Health Care of the House
Committee on Veterans' Affairs and the Subcommittee on Health and the
Environment and the Subcommittee on Oversight and Investigations of the
House Committee on Commerce, 106th Cong, 1st Sess (2000) (testimony of
Donald Berwick, MD, member Committee on Quality of Health Care in
America, Institute of Medicine).
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The increasing complexity in patient care in addition to the
public's increased scrutiny of the health care system underscores the
need to make patient safety an issue of high priority. The American
Academy of Pediatrics and its members are committed to improving the
health care system to ensure that infants, children, adolescents, and
young adults receive the best and safest health care.
All health care systems should be designed to prevent errors. The
first step in designing these systems is to identify errors and study
their pattern of occurrence within delivery systems to reduce the
likelihood of adverse events. A specific concern in pediatrics is the
lack of information on errors in the pediatric population and the
strategies needed to minimize errors and maximize care in both the
ambulatory (including schools and child care settings) and inpatient
sectors. If the Academy is going to implement an effective and far-
reaching agenda to address the public policy and research components of
the patient safety debate, the set of principles listed below should
serve as its guide.
RECOMMENDATIONS FOR IDENTIFYING AND LEARNING FROM ERRORS
1. LPediatricians are committed to bringing about the best
possible health outcomes for children and their families.
Because all medical interventions involve known and unknown
risks, pediatricians should work with health care teams to
create safe patient care environments and prevent medical
errors.
2. LEfforts to improve patient safety and prevent errors
should focus on a systems approach. Existing research on
hospital-based care reveals that medical errors rarely
represent the failure of an individual caregiver. Most errors
in medical care are systems errors related to equipment,
complex processes, fragmented care, and lack of standardized
procedures.
3. LSystems should be developed to identify and learn from
errors. These error learning systems should be open, promote
discussion of errors without blame, and provide contextual data
about the error. The Institute of Medicine has called for a 50%
decrease in the rate of medical errors over the next 5 years,
which can be realized only by researching the underlying causes
of medical errors, creating effective interventions, and
addressing future prevention.\1\ These efforts must be
completely separate from punitive strategies. Peer review
protections should be extended to encourage participation in
efforts to decrease the rate of medical errors. Currently,
state and federal laws provide legal protection so health
professionals can be candid during peer review without fear of
legal action. This should also apply to situations in which a
medical error occurs.
Error reporting systems are one part of an error learning system.
We can identify and learn from errors through reporting programs aimed
at ensuring the systems are safe for patients. To do so, reporting
systems should:
LBe nonpunitive;
LRequire that only the most critical events
be subject to mandatory reporting;
LRequire that information reported to
internal and external patient safety review groups
should not be discoverable in civil or criminal legal
action;
LAllow individuals involved in the events to
remain anonymous whether or not error is involved;
LRecognize that adverse events may or may
not be caused by errors;
LFocus on systems failures; and
LSupport the key role that organizational
leadership plays in systems improvement.
3. LMost research on medical errors is hospital based. It may
not be appropriate to extrapolate the number or types of errors
found in hospitals to the number or types of errors that might
be found in ambulatory health care settings. Because most
health care is delivered in ambulatory care settings, and in
pediatrics, many medications are taken outside of the home (in
schools and child care settings), research on errors in
ambulatory care settings should be a priority, particularly for
unique patient populations, such as infants, children,
adolescents, young adults, and children with special needs. The
problem of drug dose calculation errors for pediatric patients,
in particular, should be explored.
RECOMMENDATIONS FOR DEVELOPING PERFORMANCE STANDARDS AND EXPECTATIONS
FOR SAFETY
1. LPatient safety guidelines should be developed through the
coordinated actions of oversight organizations, group
purchasers, and professional groups. These guidelines should be
reasonable and based on a true assessment of the risk level
associated with the specific patient safety intervention. In
addition, recommended safety strategies should be flexible
enough to allow health care providers to adapt them to varied
delivery settings and to pediatric patients' needs.
2. LHealth care organizations should take into account unique
pediatric safety issues. These include particular attention to
the potential for errors in care attributable to changes in
patient weight and physiologic maturation, limited capacity for
cooperation in young children and high levels of dependency on
others, and the relative rarity of most pediatric illnesses and
accordant lack of widespread familiarity with their care. As
uniform regulations and guidelines are developed, they should
encompass the service delivery systems and their variations.
The goal of pediatric patient safety systems inside health care
organizations should be the implementation of safe practices.
3. LInformation technology has great potential to minimize
medication errors. Computerized order entry has been shown to
decrease errors and coordinate care given by many individuals
to a single pediatric patient.\3\ It is imperative that
research examine the many uses of information technology to
improve patient safety and ways to facilitate clinician
acceptance of information technology in ambulatory and
inpatient settings.
---------------------------------------------------------------------------
\3\ Kaushal R, Bates DW, Landrigan C, et al. Medication errors and
adverse drug events. Pediatr Res. 2000;47:201. Abstract 1188.
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4. LAll individuals involved in providing health care to
children should work together to:
LDevelop and enforce standards for the
design of drug packaging and labeling that will
maximize safety in use;
LRequire pharmaceutical companies to test
proposed drug names to identify and remedy potential
``sound-alike'' and ``look-alike'' confusions with
existing drug names;
LEstablish appropriate responses to problems
identified through postmarketing surveillance,
especially for concerns that are perceived to require
immediate response to protect the safety of patients;
and
LSupport expanded efforts to include
children in new drug trials.
RECOMMENDATIONS FOR LEADERSHIP AND KNOWLEDGE
1. LThe Academy supports the creation of a Research Center
for Patient Safety within the Agency for Healthcare Research
and Quality. The Academy urges that this center be adequately
funded to address the protection of all patients.
2. LHealth care organizations should demonstrate their
commitment to pediatric patient safety by establishing patient
safety programs with defined executive responsibility in all
settings where medications are delivered or care is provided to
children and by developing a culture of improvement. Patient
safety programs should:
LProvide strong, clear, and visible
attention to safety;
LRepresent a collaborative effort of
physicians, nurses, allied health personnel, and
administrative staff who have experience with and
knowledge of patient safety;
LIncorporate well-understood safety
principles, such as standardizing and simplifying
equipment, supplies, and processes;
LImplement proven medication safety
practices;
LEstablish interdisciplinary learning
programs; and Address the special needs of inpatient
and ambulatory care environments.
3. LResearch that explores the effect the error debate has on
families' satisfaction with health care services should be
conducted.
Promoting safety requires changing the culture of medicine to
recognize that the potential for errors exists and that teamwork and
communication are the basis to guarantee change. The promotion of
patient safety and the decrease in the rate of errors should become one
of the major goals of the Academy. Safety should be viewed as one
component of a broader commitment to providing optimal health care for
children--a goal that the membership embraces and that unites
pediatricians with the families they serve.
NATIONAL INITIATIVE FOR CHILDREN'S HEALTH CARE QUALITY PROJECT ADVISORY
COMMITTEE
(NICHQ PAC), 2000-2001
Carole M. Lannon, MD, MPH, Chairperson
Barbara Jane Coven, MD
F. Lane France, MD
Gerald B. Hickson, MD
Paul V. Miles, MD
Jack T. Swanson, MD
John Ichiro Takayama, MD, MPH
David L. Wood, MD, MPH
Loren Yamamoto, MD, MPH
The recommendations in this statement do not indicate an exclusive
course of treatment or serve as a standard of medical care. Variations,
taking into account individual circumstances, may be appropriate.
Copyright 2001 by the American Academy of Pediatrics.
No part of this statement may be reproduced in any form or by any means
without prior written permission from the American Academy of
Pediatrics except for one copy for personal use.
Statement of David G. Schulke, American Health Quality Association
The American Health Quality Association represents independent
private organizations--known as Quality Improvement Organizations
(QIOs)--that hold contracts with the Centers for Medicare and Medicaid
Services (CMS) to improve the quality of care for Medicare
beneficiaries in all 50 states and U.S. territories.
Congress created the QIO network to monitor and improve the quality
of care delivered to Medicare beneficiaries and supports the work of
the QIOs with about $300 million annually from the Medicare Trust Fund.
In the early years of the program, QIOs were known as Peer Review
Organizations and focused on oversight--on catching ``bad'' doctors and
hospitals. However, over the past decade QIOs have dramatically changed
their approach.
QIOs today work directly and cooperatively with hospitals and
medical professionals across the country to implement quality
improvement projects that address the root causes of medical errors.
QIOs today are working to accomplish what this committee--in its
announcement of this hearing--suggests should be a major bipartisan
goal: resolving endemic problems that result from failing systems of
care.
QIOs are improving the quality of health care not only by targeting
errors of ``commission''--medical errors that make the headlines--but
also by systematically working with medical professionals to reduce
errors of ``omission'' that result in care that falls short of
evidence-based medicine. Examples of errors of omission include failure
to administer antibiotics prior to major surgery, or failure to
prescribe ACE inhibitor drugs to appropriate heart failure patients.
Why The QIO Approach Works
QIOs are local organizations, employing local professionals, with a
national mandate to improve systems of care. As such, QIOs act as
catalysts for change trusted by both beneficiaries and providers. QIOs
educate beneficiaries about preventive care and encourage hospitals and
doctors to adopt and build into daily routines ``best practices'' for
treating seniors with common and serious medical conditions.
Medical professionals work voluntarily and often enthusiastically
with QIOs because QIO projectsreduce duplication of effort and burden
on doctors participating in multiple hospitals and health plans. These
projects also reduce the burden on hospitals that participate in
multiple health plans, by bringing the parties together to work on the
same urgent clinical priorities, using the same measures, the same
abstraction tools, the same key messages. Even the best consultants
working for individual hospitals cannot have this effect--and many
providers cannot afford costly consultants. In short, QIOsaccelerate
diffusion of evidence-based medicine to all providers--small, large,
urban and rural.
What QIOs Have Accomplished
QIOs use data to track progress towards eliminating errors and
improving treatment processes. They use data to measure hospital and
provider performance on a list of clinical indicators over the course
of a QIO project, and then compare results to baseline data to document
change.
From 1996-1999, QIOs worked on local projects to improve clinical
indicators in care for diseases and conditions that broadly afflict
seniors--heart attack, congestive heart failure, stroke, pneumonia,
diabetes, and breast cancer. Results from these projects show that QIOs
have already made a significant difference. The latest available
national data (1996-1998) show QIO projects resulted, for example, in:
L34% more patients getting medications to prevent a
second heart attack;
L23% more stroke patients receiving drugs that
prevent subsequent strokes;
L12% more heart failure patients getting treatment
needed to extend their active lives;
L20% more patients hospitalized with pneumonia
receiving rapid antibiotic therapy.
In 1999, CMS launched a national campaign for QIOs to improve care
for cardiovascular conditions, pneumonia, diabetes, and breast cancer.
The campaign began with creation of the first national quality portrait
for Medicare. This baseline data showed considerable room for
improvement in standard care in the six targeted clinical areas.
The baseline data for heart attack treatment, for example, shows
the following percentages of patients (by state) receiving evidence-
based care:
------------------------------------------------------------------------
Best State Worst State
------------------------------------------------------------------------
Prompt aspirin administration 97% 67%
------------------------------------------------------------------------
Aspirin at discharge 97% 60%
------------------------------------------------------------------------
Prompt beta blocker administration 79% 33%
------------------------------------------------------------------------
Beta blocker at discharge 93% 47%
------------------------------------------------------------------------
Recent re-measurement of a significant segment of this national
data (for 19 states) indicates that QIO interventions are having
substantial impact. For example, initial re-measurement data on
reducing system failures in the treatment of heart attacks and
pneumonia show:
------------------------------------------------------------------------
I60Heart Attack Clinical Process Median State Improvement
------------------------------------------------------------------------
Prompt aspirin administration 16%
------------------------------------------------------------------------
Aspirin at discharge 18%
------------------------------------------------------------------------
Prompt beta blocker administration 26%
------------------------------------------------------------------------
Beta blocker at discharge 26%
------------------------------------------------------------------------
------------------------------------------------------------------------
I60Pneumonia Clinical Process Median State Improvement
------------------------------------------------------------------------
Antibiotic within 8 hours 8%
------------------------------------------------------------------------
Appropriate antibiotic 18%
administration
------------------------------------------------------------------------
Pneumococcal vaccination 15%
------------------------------------------------------------------------
Besides participating in the national campaign to improve care in
these six critical areas, QIOs are working to improve care in rural
areas, to improve care for minority and ethnic populations, and to
cooperate more closely with community-based groups that focus on better
health care. QIOs are also working with nursing homes on the prevention
of pressure sores, fall prevention, pain management, development of
quality measures for rehabilitation services, improving diabetes
outcomes, improving anticoagulant use, and conducting state-wide
immunization campaigns.
Looking Ahead
CMS recently announced new directions for QIO efforts over the
2002-2004 contract period. National QIO quality improvement efforts
will be expanded beyond the six original clinical areas to include care
provided by nursing homes and home health agencies, reduction of
surgical site infections in hospitals, and work with physicians offices
on improving care for chronic diseases and preventive services such as
cancer screening and adult immunizations.
QIOs will also be deeply engaged in a new CMS initiative to educate
consumers with quality information to help them choose higher quality
providers and motivate poor performers to improve. While CMS will be
publishing the data, QIO efforts will be critical to public
comprehension and use of the data. Nursing homes motivated to improve
performance will receive QIO technical assistance to implement
strategies that have worked in similar settings.
Recommendation
We urge the Committee to take closer note of what this program has
accomplished and to verify its value through discussions with leaders
of the medical community. We look forward to working with the Committee
as it considers legislation to improve the quality and safety of
Medicare.
__________
Confidentiality Requirements for
Medicare Quality Improvement Organizations
The confidentiality of information collected or developed by a
Medicare Quality Improvement Organization (QIO) is assured by Section
1160 of the Social Security Act. It was the intent of Congress in
drafting this provision to provide safeguards for information
identifying a specific patient, practitioner or reviewer. These
safeguards foster an environment that is conducive to quality
improvement efforts and learning from errors.
Generally, the disclosure of data or information collected or
developed by a QIO in carrying out its functions for Medicare is
strictly prohibited. This information is not subject to subpoena or
discovery for the purposes of an administrative or civil action.
Further, the law states that any individual who violates the
prohibition is subject to criminal fines and/or imprisonment.
The law does provide exceptions for QIOs to disclose to specific
individuals or entities information that may identify providers or
practitioners. Under certain circumstances, QIOs may provide such
information to the practitioner or the institution where the
practitioner works, State licensure and certification agencies, fraud
and abuse or public health officials. These entities may only disclose
information obtained from a QIO in the context of a judicial,
administrative or other formal legal proceeding resulting from an
investigation conducted by the agency. All of these exceptions are for
the intended purpose of identifying and protecting the public from
substandard care, fraud or abuse.
The confidentiality of QIO quality improvement efforts has helped
establish a relationship of trust with providers. Currently, nearly 80%
of Medicare hospitals nationwide are working with QIOs on one or more
quality improvement projects. QIOs have also had some success working
with outpatient physician offices, nursing homes and home health
agencies. Efforts in the non-hospital settings will increase
dramatically over the next few years.
The QIO approach to improving care is voluntary, educational,
collaborative and non-punitive. Through this approach, QIOs have
assisted providers and practitioners in identifying quality issues and
instituting appropriate changes to bring about measurable improvement.
This process has achieved significant improvements in the quality of
care for Medicare beneficiaries--and improving systems of care with
Medicare participating practitioners and providers improves care for
all patients.
March 2002
Statement of the American Society for Clinical Pathology
The American Society for Clinical Pathology appreciates this
opportunity to comment on patient safety, an issue of great importance
to the pathology and laboratory community. This statement focuses on
patient safety initiatives within the pathology and laboratory medicine
field, and shows how health care quality may improve as a result.
The American Society for Clinical Pathology (ASCP) is a nonprofit
medical specialty society representing 151,000 board certified
pathologists, other physicians, clinical scientists (PhDs), medical
technologists and technicians. It is the world's largest organization
representing pathology and laboratory medicine. As the leading provider
of continuing education for medical laboratory personnel, the ASCP
enhances the quality of the profession through comprehensive
educational programs and materials.
The purpose of the ASCP is to improve public health by advancing
the science and practice of pathology and laboratory medicine. Patient
safety is an important part of this principle. To continue its
leadership role in advancing patient safety, ASCP has developed a
Patient Safety Initiative, which encompasses every part of the
laboratory.
Transfusion Medicine Protocols
Transfusion medicine laboratory professionals have a long tradition
for error detection and prevention systems by following standard
operating procedures and conducting audits. While the proper
application of these complex processes is critical to transfusion
safety, dependency on numerous, diverse human interactions makes these
processes prone to accidents and errors. Blood administration-related
accidents and errors--which occur outside the confines of blood bank/
transfusion service laboratory--represent a significant cause of
transfusion morbidity and mortality. In the ongoing quest for improved
transfusion safety, it is imperative that blood transfusion process
safety be accorded the same emphasis as blood component safety.
To address this issue, ASCP joined with the American Organization
of Nurse Executives in a Patient Safety Transfusion Medicine Project
Team to identify seven essential components of the blood transfusion
process. The joint project team developed flow charts and standard
operating procedure checklists to assist hospital personnel in
assessing the status of their own processes and procedures and take
necessary actions to close gaps that may compromise blood transfusion
safety. The preliminary results of this joint patient safety project
were unveiled last month at a workshop sponsored by the Food and Drug
Administration and the Agency for Healthcare Research and Quality.
Minimum Standards Necessary
The Centers for Medicare and Medicaid Services (CMS) found in a
recent survey that 32% of waived laboratories failed to have current
manufacturer's instructions, 16% didn't follow the manufacturer's
instructions, 9% didn't follow manufacturer's storage and handling
instructions, and 6% were using expired reagents and kits. This
preliminary information is based on a survey conducted by CMS from
October 2000 to January 2001. The results showed overall that a
substantial 48% of waived laboratories surveyed had quality testing
problems. The survey results were produced from an expanded pilot
project undertaken by the agency of 270 certificate of waiver
laboratories and 190 provider-performed microscopy laboratories
surveyed in eight states.
Standards for clinical laboratory testing such as quality control,
quality assurance, personnel standards, proficiency testing, and site
neutrality should not be eroded as they have helped to raise the
standard by which all laboratories operate. Problems that are
identified can and are being corrected with the help and guidance of
federal and private inspectors.
Use of the Autopsy
The autopsy is an important quality control vehicle. For example, a
study published in the August 1998 issue of the American Journal of
Clinical Pathology found that of 176 autopsies examined in a major
tertiary care transplantation referral center, 79 autopsies, or 44.9%,
revealed one or more undiagnosed causes of death. There were 123
undiagnosed causes of death in the 79 cases. Of the 123 undiagnosed
causes of death, 13 were sole immediate causes of death, 72 were one of
multiple immediate causes, 22 were intervening causes, and 16 were
underlying causes of death. Low-technology autopsies frequently
discover diagnoses that go undetected by modern high-technology
medicine. Through the autopsy, problems in diagnosis may be recognized
and ultimately assist in finding solutions to similar medical problems
in future patients.
To accommodate better the needs and concerns of family members,
hospitals should develop a coherent set of policies that explain the
usefulness of an autopsy. ASCP suggests that these policies may
include: developing an informational pamphlet that is made available to
the patient's family, describing the autopsy procedure and its values;
creating an office of decedent affairs within the hospital organization
to assist dying patients, families and involved members of the medical
staff to understand the details surrounding dying and death in the
hospital environment; and creating in-service programs to ensure that
nurses and social workers provide assistance in facilitating any
efforts to obtain an autopsy consent.
The ASCP firmly believes that the autopsy is necessary to monitor
the clinical judgment in the medical community. For quality assurance
purposes alone, the autopsy is a critical service. Any condition of
participation addressing the autopsy should also assure appropriate
compensation for this service.
Second Opinions in Diagnostic Anatomic Pathology
As part of its Patient Safety Initiative, ASCP hosted the
``Consensus Conference on Second Opinions in Diagnostic Anatomic
Pathology: Who, What and When'' on June 21, 2000, in Washington, DC.
The conference, which was open to the public, convened with pathology
experts of various disciplines, surgical representation, and a patient
advocate. The conferees worked to reach a consensus on what specimens
should be reviewed under second opinions, whose opinion prevails upon a
second review, when a second opinion should occur, and to develop
general guidelines for second opinions in diagnostic anatomic
pathology.
The conference determined that second opinion is an important
component of total quality assurance programs in diagnostic surgical
pathology and cytopathology and is a key aspect in the assurance of
patient safety for tissue and cytology based diagnoses. The conference
urged the implementation of educational programs to inform clinicians
and patients regarding the value of second opinion; the turn around
time delays which second opinion will produce, and the legitimate
differences of opinion that can exist in difficult cases.
It was recommended that all insurers provide a fair reimbursement
structure for second opinion services, and that funding agencies
support research into the detailed analysis of second opinion as a
patient safety mechanism and that academic pathology centers should
engage in such research. Overall, the effective use of second opinion
in diagnostic anatomic pathology is a subject that needs to be better
communicated to clinicians and patients.
Conclusion
Pathology and laboratory medicine have developed and continue to
support the use of quality processes for the systematic detection and
prevention of errors. These efforts concentrate on building safety into
the delivery of health care, similar to the recommendations of the
Institute of Medicine Committee on Quality of Health Care in America.
Many patient safety initiatives, such as those recognized in donor
blood testing and autopsies, have been absorbed by the laboratory
profession in the interest of maintaining and improving quality. As new
efforts are disseminated, it will be important that custodians of those
efforts receive the resources they need to accomplish the task.
Thank you for the opportunity to provide this statement to the
subcommittee.
Statement of the American Society of Health-System Pharmacists,
Bethesda, Maryland
The American Society of Health-System Pharmacists (ASHP) is pleased
to submit this statement for the record of the Subcommittee on Health's
hearing on health quality and medical errors. ASHP is the 31,000-member
national professional association that represents pharmacists who
practice in hospitals, long-term care facilities, home care, hospice,
health maintenance organizations, and other components of health care
systems. ASHP believes that the mission of pharmacists is to help
people make the best use of medicines. Assisting pharmacists in
fulfilling this mission is ASHP's primary objective.
The Institute of Medicine (IOM) report, ``To Err is Human: Building
a Safer Health System,'' states that since it isn't possible for nurses
or doctors to keep up with all the information necessary for safe
medication use, ``the pharmacist has become an essential resource in
modern hospital practice,'' and access to the pharmacist's expertise
must be possible at all times. For decades, ASHP has been actively
involved in promoting a fail-safe medication use system for hospitals
and other components of our nation's health system, and ASHP agrees
with the IOM that the active participation of pharmacy practitioners is
essential to the creation of that fail-safe system. ASHP stands ready
to assist the Subcommittee in developing meaningful recommendations to
implement error reduction techniques.
In general, ASHP applauds the analysis and recommendations in the
IOM report. Of particular interest to ASHP are recommendations dealing
with mandatory and voluntary reporting systems, extension of peer
review protections to data about patient safety and quality improvement
as well as initiatives to improve the medication use process through
the appropriate application of technology and the proper utilization of
pharmacists as health care providers.
The Creation of a Non-Punitive Environment For Reporting is Essential
In order to achieve the IOM's call for a 50% reduction in the rate
of medical errors over the next five years, it is essential to create a
confidential, non-threatening, non-punitive environment where errors
can be reported, the underlying cause studied, and effective
interventions devised and implemented. To do so, Congress must work
with states and the private sector to create a single, nationwide error
reporting program.
In June 2000, ASHP's House of Delegates approved the following
statement regarding the development of an error reporting system:
Policy
The incidence of death and serious harm caused by mistakes and
accidents in health care is unacceptable. This serious public health
problem merits top-priority national attention. Addressing this issue
will require major reforms and sizable investment of resources
throughout the health care system, including the medication use
process, which is a particular focus of the American Society of Health-
System Pharmacists (ASHP).
ASHP believes that the following steps should be taken as part of a
comprehensive national solution to the problem: (1) The establishment
of a standardized, uniform nationwide system (with the characteristics
noted below) of mandatory reporting of adverse medical events that
cause death or serious harm, (2) continued development and
strengthening of systems for voluntary reporting of medical errors, and
(3) strengthening efforts to implement process changes that reduce the
risk of future errors and improve patient care.
The fundamental purpose of reporting systems for medical errors is
to learn how to improve the health care delivery process to prevent
these errors. Reporting of medical errors must become culturally
accepted throughout health care. A major investment of resources will
be required in the health care system to apply the lessons derived from
the reporting of medical errors. Marshaling those resources is an
urgent issue for the governing boards of health care institutions,
health care administrators, health professionals, purchasers of health
care (including federal and state governments), third party payers,
public policy makers, credentialing organizations, the legal
profession, and consumers.
Requirements
The primary goal of mandatory reporting of adverse medical events
that cause death or serious harm should be to foster accountability for
health care delivery process changes to prevent errors or adverse
medical events. If a patient dies or is seriously harmed because of a
mistake or accident in the health care system, the practitioner or
institution responsible for the patient's care should report the
incident to a designated state health body. Further, states should be
obligated to share information based on these reports promptly with a
national coordinating body and with national programs that are designed
to improve the quality and enhance the safety of patient care.
ASHP's support of a mandatory reporting system is contingent upon
the system having the following characteristics:
1. LAn overall focus on improving the processes used in
health care, with the proper application of technical expertise
to analyze and learn from reports,
2. LLegal protection of confidentiality of patients, health
care workers, and the information submitted to the extent
feasible while preserving the interest of public
accountability,
3. LNonpunitive in the sense that the submission of a report,
per se, does not engender a penalty on the reporting
institution or practitioner or others involved in the incident,
4. LA definition of ``serious harm'' that concentrates on
long-term or irreversible patient harm, so as not to overburden
the reporting system,
5. LNational coordination and strong federal efforts to
ensure compliance with standardized methods of reporting,
analysis, and follow up, that emphasize process improvement and
avoid a culture of blame,
6. LAdequate resources devoted to report analysis, timely
dissemination of advisories based on report analysis, and
development of appropriate quality improvement efforts, and
7. LPeriodic assessment of the system to ensure that it is
meeting its intent and not having serious undesired
consequences.
Experience associated with current mandatory state reporting of
adverse medical events and mandatory public health reporting of certain
infectious diseases should be assessed, and the best practices of such
programs should be applied to the new system of mandatory reporting of
adverse medical events that cause death or serious harm.
The primary goals of voluntary reporting of medical errors should
be quality improvement and enhancement of patient safety. Reports by
frontline practitioners of errors and ``near misses'' are a strength of
such programs when report analysis and communication lead to prevention
of similar occurrences. The public interest will be served if
protection is granted to individuals who submit reports to voluntary
reporting programs. The Medication Errors Reporting Program operated by
the United States Pharmacopeia in cooperation with the Institute for
Safe Medication Practices is an important initiative that merits
strengthening; this program may be a model for voluntary reporting of
other types of medical error.
It is important to emphasize the necessity of nationwide peer
review protections to the successful implementation of any error
reporting program. ASHP supports ``federal legislative and regulatory
initiatives that provide liability protection for the reporting of
actual and potential medication errors by individuals and health care
providers.'' Further, ASHP supports ``federal liability protection for
medication-error reporting that is similar in concept to that which
applies to reporting safety incidents and accidents in the aviation
industry.''
Since current legal protection for medication error reporting (both
actual and potential as defined in ASHP's ``Guidelines on Preventing
Medication Errors in Hospitals'') is based primarily on state peer-
review protection statutes or on case law, the extent of protection
varies substantially throughout the country. For example, some states
may limit protection to records prepared by peer-review committees and
do not protect records provided to these committees. Given the state-
to-state variance, medication errors may not be reported in a
consistent and uniform manner, making trend analysis and subsequent
corrective measures difficult.
Individual practitioners and health care entities may be hesitant
to report medication errors for fear that the information could be used
in civil liability lawsuits against them. There is no federal
protection for individuals and entities reporting medication errors to
national reporting programs. This lack of protection, and the
consequent incomplete reporting, means that individual practitioners,
health systems, pharmaceutical manufacturers, and other public and
private organizations cannot learn of the component parts of a system
error and develop corrective measures to enable a fail-safe medication-
use system.
Such protection would only cover the information submitted to a
designated national reporting entity. Individual practitioners and
healthcare entities still would remain susceptible to liability action
as a result of underlying incidents that form the basis of the report
if the incident resulted in harm to an individual.
Federal legislation providing liability protection for the
reporting of actual and potential medication errors would neither help
nor harm individual patients who are injured, but it should help
patients collectively because the reported data could be used to reduce
the incidence of avoidable errors. Individual patients would still be
able to seek a legal remedy for their injuries. Seeking this limited
federal protection is preferred over attempting to obtain uniform
protection from all 50 states.
ASHP and its members have a great deal of experience with existing
reporting systems and will participate in the further development of
mandatory or voluntary reporting programs.
LAppropriate Application of Technology Improves the Medication Use
Process
Everyone agrees that the number of medication-related errors is too
high. Handwritten clinical data, incomplete, outdated or improperly
implemented information technology increases the likelihood that this
number will remain unnecessarily high. Research demonstrates that
patient-safety geared information technology, when used appropriately
and under the leadership of health-system pharmacists, who are
responsible for the appropriate, accurate, and timely distribution of
medications, can improve quality of care and reduce medication-related
errors.
The biggest obstacle for hospitals when it comes to implementing
information technology enhancements is the enormous cost of researching
these systems, purchasing the necessary hardware and software, as well
as training staff to use the technology properly.
The March 2001 IOM report, ``Crossing the Quality Chasm: A New
Health-System for the 21st Century,'' urges a significant national
investment in information technology geared toward improving the
quality of health care delivery.
ASHP supports a voluntary grant program that would provide funding
for early adopters of new technology to meet the high price tag of this
new technology as well as the necessary and important expense
associated with properly educating and training staff on the correct
use of the information system. The Medical Error Reduction Act (H.R.
3292), introduced last year by Ways and Means Committee members Amo
Houghton (R-NY) and Karen Thurman (D-FL), would go a long way toward
achieving this goal. Senators Bob Graham (D-FL) and Olympia Snowe (R-
ME) have introduced similar bipartisan legislation (S. 824) in the
Senate.
Recognizing Pharmacists as Health Care Providers Under Medicare
Improves Quality of Care, Reduces Errors
Our nation's health care system relies heavily on thousands of
powerful new prescription medicines to treat all sorts of diseases and
conditions. Many patients, especially those over the age of 65, find
themselves taking a bewildering array of medications. As medication use
rises, so to does the risk of medication-related complications. Yet,
despite being among our nation's highest risk patients, Medicare
beneficiaries often have limited access to the valuable services of
pharmacists.
As the IOM and others have recognized, pharmacists play an
important role in improving the quality of patient care and reducing
the risk of dangerous (and costly) medication-related complications.
Working closely and collaboratively with physicians, the pharmacist is
a trusted counselor who helps to streamline drug therapies prescribed
by a number of specialists, matching effective therapies with patients'
unique needs. Pharmacists also play vital roles in follow-up care,
monitoring patient response and advising physicians on changes in
dosage, medicine, or delivery method.
Currently, Medicare does not compensate pharmacists for these
important patient care services. Because pharmacists are not considered
``health care providers'' under Medicare, their experience is
underutilized, patient care is diminished, and reductions in
unnecessary expenditures are not realized. Simply put, Medicare payment
policies have not advanced to match the pharmacist's critical role in
health care.
ASHP supports the passage of legislation to update Medicare
statutes to recognize pharmacists as health care providers in a similar
manner as other non-physician practitioners, including registered
dieticians, nurse practitioners, physician assistants, certified nurse
midwives, and clinical social workers, are recognized. Legislation, the
Medicare Pharmacist Services Coverage Act (H.R. 2799/S. 974), has been
introduced in both the House and Senate to achieve this goal. This
important legislation will ensure that the entire health care team is
able to properly utilize the pharmacist's expertise in drug therapy
management.
Conclusion
ASHP thanks Chairwoman Johnson, and members of the Subcommittee for
holding this important hearing. We appreciate the opportunity to submit
a statement for the record and look forward to working with the
Subcommittee and other members of Congress to develop effective patient
safety legislation.
Statement of Trace Devanny, Cerner Corporation, Kansas City, Missouri
Madam Chairman and members of this committee, thank you for the
opportunity to submit testimony outlining our views on the role of
technology in improving healthcare quality and patient safety in the
U.S.
My name is Trace Devanny and I am the president of Cerner
Corporation. We are a $543 million company with our headquarters
located in Kansas City, Missouri. We are considered by many to be the
world's leading developer of clinical information systems software for
the healthcare industry and our mission as a company is to transform
healthcare through the implementation of information systems that
improve healthcare quality and patient safety in the U.S. and around
the world.
I would like to take a moment to thank the members of this
committee for focusing attention on this important issue in healthcare.
Your commitment will prove to be critical as we move forward to improve
quality and safety for patients in the U.S. healthcare system.
Healthcare Problems
As this committee has no doubt learned by now, the U.S. healthcare
industry is beset with serious problems--especially the 19th
century approach of our healthcare with respect to technology. Nearly
every other major U.S. industry has already moved to automate its
systems. Try to imagine the banking and finance industry without
computers. The airline industry is almost completely reliant upon its
automated systems. Even your local car dealer has computers to track
your service record when you go in for a repair.
Yet the healthcare industry, one of the largest industries in the
U.S., continues to do business primarily the same way that it has for
more than 150 years--with paper and pen. We have a saying at Cerner
that the pen is the most dangerous medical device in healthcare today.
This Committee is obviously familiar with the December 1999
Institute of Medicine (IOM) study that estimated as many as 98,000
people die each year as a result of medical errors. But there are more
storm clouds on the horizon for the healthcare industry. The graying of
the baby boomer generation is about to create an unprecedented stress
on our healthcare system--a system that is already overutilized and
undercapitalized. And the baby boomers are going to peak during a
critical workforce shortage. There is also enormous variance in
treating patients while redundant and wasteful procedures eat up
enormous costs.
Perhaps just as important, the follow-up March 2001 IOM study
states that technology and clinical automation is one of the critical
solutions to reduce the number of deadly medical errors. The value
proposition for using technology in healthcare is relatively
straightforward--20-40 percent cost reductions, the elimination of most
medical errors, and the empowerment of consumers to better manage their
own health. The IOM report tells us ``automation of clinical, financial
and administrative transactions is essential to improving quality,
preventing errors, enhancing consumer confidence in the health system
and improving efficiency.'' The IOM goes on to suggest $1 billion as a
reasonable starting point to assist the healthcare industry in adopting
needed technologies.
I should point out here that we believe $1 billion is a positive
first step but that it will actually require far more than $1 billion
to impact today's healthcare industry significantly. There is little
question that the financial health of the current healthcare system
will not support the large-scale investments necessary to address the
current safety problems in healthcare.
An enormous transformation needs to occur--and quickly. Today's
situation might be compared to the critical `access' issues facing this
country after World War II. At that time, as you may recall, Congress
responded by passing the Hospital Survey & Construction Act-- better
known as ``Hill-Burton.'' It was a massive infrastructure program
providing the funding to build many of the nation's hospitals. But
today's congressional imperative is not to build more facilities.
Rather, it's to help establish a higher-quality, safer health system. A
massive congressional effort needs to coalesce around funding for
technology systems that provide demonstrated return on investment (ROI)
and elimination of medical errors on a very large scale.
A Solution
Given the current state of the economy, however, and the limited
resources of Congress, it is not realistic to think this enormous
investment will take place immediately. Until there is support for a
movement to fund a large-scale effort for technology infrastructure in
healthcare, Congress should provide incentive funding for providers to
help with the expense of automating systems that improve quality and
patient safety. Capital reimbursement methods within Medicare or
Medicare competitive grants are two possible ways to move provider
systems towards automating their systems--and we believe these ``seed
funds'' would provide a greater return than the original investment.
A terrific first step in this evolution is the introduction of H.R.
3292. Cerner strongly supports this legislation and applauds Congress
for taking this important first step in moving healthcare towards
better quality and patient safety.
The Value of Information Technology in Healthcare
At Cerner, we believe deeply that the value proposition of
information technology in healthcare is relatively straightforward.
Technology will:
Leliminate the majority of the avoidable medical
errors;
Lreduce the cost of healthcare by 20-40 percent;
Lreduce the enormous variance that currently exists
around how physicians diagnose and treat the same medical
problem;
Lempower the consumers to better manage their own
health by giving them access and control of their own medical
records; and
Limprove workforce retention.
There are several provider systems that have shown value through
the use of healthcare IT systems. For example:
LA peer-reviewed study conducted by officials at the
Banner-Samaritan health system in Phoenix was published in the
Journal of the American Medical Association (JAMA) in 1998. The
study measured the results of an adverse drug event warning
system that had been implemented at the Banner Samaritan 650-
bed site. The study concluded that Banner-Samaritan saved $3
million and 36 lives annually through the use of its healthcare
information system. And the results today would be even more
dramatic because of the rapid advances made in healthcare IT
systems at Cerner.
LDetroit Medical Center saved $30 million in 2000
and projected savings of $50 million in 2001 due to improved
charge capture and a reduction in redundant procedures.
LThe INTEGRIS Health system, which operates 15
hospitals across Oklahoma, is saving approximately $5 million
annually by reducing inappropriate or redundant medical
procedures through the use of advanced information software.
LThrough the use of electronic medical records,
physicians at the University of Illinois Medical Center at
Chicago (UIC) are spending 30 percent less time looking for
charts and five hours a week less reviewing resident orders.
LAlso at UIC, radiologists are saving one hour per
day, and $1.3 million in nursing time has been reallocated away
from administrative tasks by using technology patient safety
information systems.
Should Congress provide incentive funding, it would find itself
with more proof points across the U.S. that show better quality and
safety in healthcare. By allowing visionary sites around the country
access to compete for funding for IT implementation, Congress will
almost immediately begin to make the business case for the industry
through reduced costs, improved quality and better patient safety.
There will also be real, measurable savings in the Medicare system.
Companies like Cerner cannot help to bring about this massive
transformation alone. It will require a unifying force of leadership on
a grand scale--and Congress must lead the way. By providing this
leadership, Congress will help to save lives and address many of the
overwhelming issues facing healthcare in the U.S. today.
Once again, I appreciate the opportunity to provide input into this
committee's efforts to improve patient safety and our healthcare
system. Cerner looks forward to working with this committee to improve
the quality and safety of our healthcare system. I am available to
answer any questions the committee may have now or in the months ahead.
Thank you.
Statement of the College of American Pathologists
The College of American Pathologists (CAP) is pleased to submit
this statement for the record of the Subcommittee on Health's hearing
on health quality and medical errors. The College is a medical
specialty society representing more than 16,000 board-certified
physicians who practice clinical or anatomic pathology, or both, in
community hospitals, independent clinical laboratories, academic
medical centers and federal and state health facilities. The CAP thanks
subcommittee Chair Nancy Johnson and the subcommittee's members for
their interest in improving health care quality and patient safety.
The CAP is the leading advocate for quality medical testing for
patients. The College accredits more than 6,000 laboratories, provides
proficiency testing for more than 20,000, and offers various other
quality improvement programs. Further, the College has developed the
Systematized Nomenclature of Medicine (SNOMED), the world's most
comprehensive international and multilingual clinical reference
terminology with broad applications in patient safety and error
reduction efforts.
As you may know, the College, in partnership with the Centers for
Medicare and Medicaid Services and other agencies, works to ensure
Medicare beneficiaries and patients nationwide receive quality care in
the laboratory. The Clinical Laboratory Improvement Amendments of 1988
(CLIA) recognize CAP accreditation as an acceptable substitute for
federal laboratory inspections. Also, the College has worked closely
with the Department of Health and Human Services on cancer screening,
laboratory standards, genetic testing and other issues.
CAP Laboratory Accreditation Program (LAP) inspections and
Proficiency Testing form the foundation of College quality improvement
activities. The LAP has long led efforts to improve the accuracy and
reliability of laboratory testing, thereby reducing errors and helping
to ensure safer patient outcomes. Dovetailing with LAP is the College's
Proficiency Testing program, which allows laboratories worldwide to
compare their performance with that of peers and improve outcomes
within the laboratory.
Two other CAP quality improvement programs of particular note are
the Cancer Protocols and Patient Outcomes Templates. Cancer Protocols,
co-developed with clinicians, standardize the evaluation and reporting
of cancer specimens and help ensure all relevant information is
consistently documented and available to best treat cancer patients.
Complete pathology reports written in a clear format help protect
patients from improper treatment by eliminating physician confusion
about or misunderstanding of pathologic findings. The College's Patient
Outcomes Templates respond to an emerging need in the marketplace for
tools to improve communication and foster outcomes quality improvement.
Pathologists and clinicians use this program to accurately evaluate and
report specific conditions within their institution to determine the
need for improvement. Both the Cancer Protocols and Patient Outcomes
Templates are peer-developed and peer-reviewed, and made available at
no charge to all CAP members.
Other College offerings targeted at quality improvement and error
reduction include the Q-Probes and Q-Tracks programs, which allow
laboratories to assess the quality of their clinical and anatomic
pathology services by benchmarking their performance against other
participating laboratories in the programs. Also of note is that
several of the Q-Probes programs deal specifically with detecting
errors.
SNOMED
The College's concern for quality extends beyond the laboratory
walls. Accurate, comprehensive and efficient communication among
physicians, laboratories, hospitals and other providers is essential to
ensuring quality. A common language understood by all health
professionals improves the coordination of patient care and can reduce
the occurrence of medical errors.
The College's Systematized Nomenclature of Medicine, or SNOMED, is
such a language. SNOMED is the most comprehensive international and
multilingual clinical reference terminology available in the world. Its
unparalleled scope delivers to the entire health care community
unprecedented uniformity for medical communications that spans
languages, clinical specialties and geographic borders.
SNOMED Clinical Terminology, for example, contains approximately
325,000 concepts linked to clinical knowledge to enable accurate
recording of data without ambiguity. The terminology's content also
includes more than 800,000 descriptions or synonyms relating to
clinical concepts, as well as more than 950,000 links, known as
semantic relationships, between clinical concepts. This structure
ensures the proper relationships of diseases, treatments, etiologies,
clinical findings, therapies, procedures and outcomes.
The possible applications of SNOMED are nearly limitless. The
terminology is highly flexible, allowing its use by a wide variety of
health care enterprises--from the individual clinician to major
pharmaceutical companies, government agencies and nationwide provider
organizations. The terminology will help users reduce administrative
costs related to the delivery of health care worldwide by supporting
the electronic patient record. It can be used to standardize surgical
records, to code patient problem and diagnoses lists, to support
computerized physician order-entry, to facilitate consistent tracking
of infectious diseases, to report the incidence of cancer cases, to
facilitate bioterrorism surveillance or to encode health-related
literature, among many other possible uses.
When used in software applications, SNOMED serves as the common
index or ``dictionary'' against which data is encoded, stored and
referenced. This provides greater compatibility across software
applications as computer codes used to capture medical concepts in one
system can be interpreted and linked to terms with the same meaning in
another. The terminology allows clinicians to precisely capture
information about a patient's history, illnesses, treatments and
outcomes in a consistent and computer-readable manner. More important,
SNOMED is designed in a way that allows reuse of coded information for
evidence-based medicine, outcomes studies, clinical research and
administrative reporting.
By enabling consistent coding of clinical concepts, with clear
relationships between terms and concepts, SNOMED helps ensure
comparability of data recorded by multiple practitioners across diverse
and often incompatible platforms and systems. For example, an internist
in New York can communicate SNOMED-encoded patient data to a
radiologist in France, and the radiologist can immediately understand
and apply the information, even if using a completely different
language and software system.
Whether data is retrieved from a single patient, a group of
patients or an entire population, SNOMED improves the coordination of
patient care, provides data crucial to quality improvement efforts and
can reduce medical errors. Specifically, SNOMED:
LProvides clarity--and reduces the chance of
misinterpretation--in the coding of patient information and
improves understanding of a patient's condition through access
to more complete clinical documentation.
LAllows health care providers to retrieve important
information that might otherwise be buried among paper records.
LProvides better, more complete access to important
patient information that can be linked to clinical alerts,
knowledge databases and health education tools.
LAllows the systematic collection and analysis of
data on errors, which provides access to important information
necessary for statistical reporting that might otherwise be
lost among paper records.
LProvides greater clinical specificity to support
problem lists, outcomes research, performance measurement and
quality improvement.
LShifts investment from gathering and integrating
data for population-based studies to understanding and
interpreting the results and their implications on cost and
quality of care.
While the extensive features of SNOMED are appropriately complex,
its bottom-line benefit is simple: It helps health care professionals
deliver the best possible patient care. In doing so, SNOMED improves
quality and can reduce the likelihood that medical errors will occur.
The CAP thanks the subcommittee for the opportunity to present its
views on this important issue and offers its support and continued
assistance as Congress considers steps to improve the quality of care
for all Americans.
Statement of eHealth Initiative
Introduction
The old adage is true: the American health care system is the best
in the world but as we now know, in terms of reducing medical errors
and increasing health care quality, our Nation could do much better.
One of the keys to building a health care system that is safer and more
effective and efficient in terms of cost, quality, and timeliness is
the increased use of information technology. Such technology can
improve and streamline clinical health care communications, data-
sharing, and interconnectivity within and across health care-related
institutions, patients, and public health agencies.
Many information technology tools that hold promise for improving
the price and process of health care exist. However, a multitude of
barriers-- including inadequate reimbursement and lack of data
standardization and connectivity issues, prevent these tools from being
widely utilized by health care providers.
eHealth Initiative Undertakes Multi-Stakeholder Efforts to Create
Safer, More Cost-Effective, Higher Quality Health Care System
Driving improvement in the quality, safety, and cost-effectiveness
of health care through information technology is the mission of the
eHealth Initiative (eHI), a non-profit organization with over 70
members representing many of the stakeholders in the health care
industry. Through its collaborative projects and education and
awareness-building activities, eHI brings health care decision-makers
from the public and private sectors to examine the role of information
technology in driving greater quality and safety as well as reducing
health care costs and undertake projects which clarify how information
technology can do just that. The organization also seeks to address two
critical barriers to a better health care system enabled by information
technology, the lack of economic incentives for better quality care
enabled by information technology and the need for greater data
standardization and connectivity within the health care system.
eHealth Initiative efforts relevant to today's hearing that relate
to how information technology can increase health care quality, safety
and cost-effectiveness fall into four key categories:
LEconomic Incentives--eHI promotes economic
incentives for better quality care through information
technology.
LMedical Errors Legislation--eHI advocated for the
passage of the ``Medication Errors Reduction Act of 2001.''
LClinical Data Standardization--eHI is focused on
driving greater clinical data standardization through the
public-private collaboration to improve public health.
LConnectivity--eHI is working to increase
connectivity between various stakeholders in the health care
system.
eHI believes that each of the above endeavors is vital because they
provide impetus to the proliferation of information technologies and
encourage the coordinated, real-time health care communications network
our Nation needs to address medical errors and health care quality
issues.
Economic Incentives for Better Quality Care through Information
Technology Needed
One of the most important steps that Congress can take to reduce
medical errors and improve health care quality is to draft and pass
legislation that provides economic incentives for better quality care
enabled by information technology within the health care setting.
Information technology has the power to improve the process and price
of health care when properly integrated and implemented with workflow
in clinical and administrative settings. Such technology can: (1)
streamline the care process; (2) result in better patient health,
productivity, and quality of life; and (3) reduce health care-related
costs.
It is commonly understood that in the face of increasing
reimbursement cuts and mounting clinical and administrative
responsibilities, health care providers want to implement information
technology solutions that decrease medical errors, lower costs, ease
office practice burden, and enhance patient health. Unfortunately, the
current health care business model does not support broad and effective
use of such solutions.
It is problematic that currently, public and private health care
incentives and reimbursements are largely based on the traditional
doctor or hospital visit model where a consultation occurs and
information is dispensed during a face-to-face interaction between
provider and patient. As medical and information technology evolves,
new care models which include the use of data from disparate clinical
and administrative information systems to support better quality care
or from remote interactions will become more prominent. Therefore,
economic incentives that fund the purchase and adoption of new
information technology to handle these functions must be implemented.
Without these incentives, the purchase of new and enhanced information
technology tools will be low on the priority list given tightened
hospital and physician budgets, high administrative costs, and valid
competing purchase and staffing priorities.
Many employers, health plans, and hospitals believe that they have
squeezed all of the possible costs out of the system through the
implementation of what many saw as the ``answer to the reduction in
health care costs''--managed care. Despite those changes, health care
costs are continuing to spiral upward. This, combined with the aging of
the baby-boomers is forcing the health care system to look for new
answers. Ironically, there is little cashflow left within these
organizations to fund the very infrastructure that will drive the next
wave of much-needed cost reduction and improvement in quality--the
strategic use of information technology.
As it has with the building of other infrastructure in the United
States over the years (such as the hospitals with the Hill-Burton Act
and the Interstate Highway System), the federal government must play an
important role in providing economic incentives for the building of the
core of this information technology infrastructure. The government has
successfully provided economic incentives for beneficial cardiac
imaging, kidney dialysis, and laparoscopic surgery, which encouraged
these technologies to flourish. eHI believes it should now provide
similar incentives in the larger realm of information technology tools.
Such incentives or reimbursements should be designed and
implemented as either add-ons to current federal reimbursement vehicles
(through programs such as Medicare, which pay for approximately one-
half of the health care in the United States) to defray the costs
related to information technology infrastructure or funded through a
variety of federally funded direct grant programs to health care
institutions and physicians' offices.
Passage of ``Medical Errors Reduction Act of 2001'' Supports Medical
Error Reduction and Health Care Quality
A second crucial step that Congress can take to reduce medical
errors and improve health care quality is to pass the ``Medication
Errors Reduction Act of 2001'' (S.824, H.R. 3292) introduced in the
Senate by Senators Bob Graham (D-FL) and Olympia Snowe (R-ME) and in
the House by Representatives Amo Houghton (R-NY) and Karen Thurman (D-
FL). These House and Senate bills are important and will improve the
basic care process by: (1) providing informatics and technology-focused
grants to hospitals and nursing homes; (2) establishing a Medical
Information Technology Advisory Board to develop, disseminating
standards for electronic sharing of information; and (3) removing one
of the major barriers to implementation of such information technology
\3/4\ financing \3/4\ by providing over $1 billion of funding to
hospitals and nursing homes to implement medication error-related tools
and systems.
Information Standardization and Connectivity Critical to Boosting
Quality, Safety and Cost-Effectiveness of Health Care
The nation is in need of an interconnected health care system, to
drive further improvements in the quality, safety, and cost-
effectiveness of care. As noted in the recent NCVHS report Information
for Health: A Strategy for Building the National Health Information
Infrastructure \1\, we as a Nation have a timely opportunity and an
urgent need to build a 21st century health support system--a
comprehensive, knowledge-based system capable of providing information
to all who need it to make sound decisions about health. This report
calls for an interconnected set of technologies, practices,
relationships, standards, and applications that support the many facets
of health and health care.
---------------------------------------------------------------------------
\1\ U.S. Department of Health and Human Services National Committee
on Vital and Health Statistics. November 15, 2001. Information for
health: a strategy for building the national health information
infrastructure.
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According to the President's Information Technology Advisory
Committee and Panel on Transforming Healthcare, the Nation's growing
information and communications capabilities already facilitate some
information flow to and communication among health decision makers. But
the health sector is lagging far behind others (banking and
entertainment, for example) in adapting and using information
technology for its own purposes.\2\ According to NCVHS, use of
information technology in the health sector has been evolving, but
without a plan.
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\2\ President's Information Technology Advisory Committee, Panel on
Transforming Health Care. February 2001. Transforming health care
through information technology. National Coordination Office for
Information Technology Research and Development.
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As is noted above, one of the key components of a national health
information infrastructure is the sharing of clinical information
within and across health care-related institutions, patients, and
public health agencies.
The amount of clinical data generated today in our Nation's
hospitals, physician offices, labs, and pharmacies, continues to grow.
Although there is an abundance of health care information and a
pressing need for its use, clinical information often can not be
utilized or combined effectively because data formats and transmission
standards are not uniform. The development and widespread adoption of
clinical data standards and the connectivity of such data is critical
to the quality, safety, and cost-effectiveness of care delivered in our
health care system.
HIPAA has provided the platform for the exchange of financial,
clinical, and administrative information on health care transactions.
These regulations will serve as a catalyst for moving the health care
industry towards efficient and standardized electronic methods for
communicating health claims, enrollment, eligibility, remittances, and
related transactions. HIPAA includes not only standards for financial
and administrative transactions, but also standards for privacy and
security. The next step, however, lies in the development and broad
adoption of clinical transaction standards.
Through the Foundation for eHealth, the eHealth Initiative is
working with the Centers for Disease Control and Prevention (CDC), the
Centers for Medicare and Medicaid Services, several state and local
health partners, national standards organizations, and key leaders in
the private sector in a public-private collaboration to transmit
clinical data of public health importance from existing health
information systems and data sources for public health surveillance
purposes, using CDC's National Electronic Disease Surveillance System
(NEDSS), which is a broad initiative designed to use national data and
information systems standards for the development of efficient,
integrated, and interoperable surveillance systems at the state and
local levels. This initiative represents a critical next step towards
accelerating greater data standardization, enhancing information
systems interoperability, and facilitating broad adoption of supporting
policies and technologies. The power of combining a national need for
interoperable systems with data and architectural standards through
CDC's NEDSS with the expertise and leadership of government and health
care industry leaders, as well as national standards organizations, is
extraordinary and will provide the catalyst that is needed to drive
greater data standardization, connectivity and compliance with privacy
and security policies--all of which serve as critical barriers to a
national health information infrastructure which is greatly needed to
drive greater quality health care.
Conclusion
In conclusion, there are a number of action steps this Subcommittee
and Congress as a whole, can take to reduce medical errors, and
increase cost-effectiveness, quality, and safety within the health care
system. First, work must begin to construct and pass federally-funded
economic incentives for better health care through information
technology. Second, comprehensive medical errors legislation such as
the ``Medication Errors Reduction Act of 2001'' must become law. And
lastly, the public and private sectors must work collectively to
increase data standardization and connectivity within and across health
care-related institutions, patients, and public health agencies. eHI
and our members stand ready to lend our voice and private-sector
expertise in these endeavors.
Statement of Mark R. Grealy, Healthcare Leadership Council
The Healthcare Leadership Council (HLC) is a coalition of chief
executives of the nation's leading health care companies and
organizations representing all sectors of health care. Our members are
committed to advancing a market-based health care system that values
innovation and provides affordable, high-quality health care. HLC would
like to thank the committee for focusing today on health quality and
patient safety and for the opportunity to submit this statement.
While Congress considers how to enhance the safety of the nation's
health care system through legislation, we ask you to consider also the
numerous steps the health care industry has initiated to reduce error
rates and to continually increase the quality of the care it delivers.
Many health care providers are reducing human error by upgrading their
systems technologies through the use of computerized physician-order
entry, computerized on-floor pharmacies, and scanning bar-codes at the
patient bedside. Manufacturers are changing their packaging to dose-by-
dose packages, improving dosage and interaction instructions, and
eliminating look-alike packages and names. Hospitals are removing high-
error medicines from patient floors. Many hospitals are also
voluntarily submitting error data to organizations like the Joint
Commission on Accreditation of Health Organizations and U.S.
Pharmacopia, where they receive analysis and feedback of how to avoid
similar errors in the future. These are just a few of the many examples
of some of the activities underway within our membership.
In an effort to increase safe practices and to cross-educate health
organizations, HLC has launched its own effort and formed a Chief
Executive Task Force on Patient Safety. Our goal is for the various
sectors of the health care industry to work together to help elevate
public confidence in the safety of the nation's health care system. We
are accomplishing this by uniting behind a self-initiated protocol for
addressing patient safety in the health care system responsibly,
positively, and tangibly.
The HLC task force is guided by the following eight principles
which we offer for the committee's consideration as it evaluates
potential patient safety legislation:
1. LSolutions should be developed collaboratively and with
executive responsibility and leadership. A zero error medical
environment will require devoted, thoughtful and creative
collaboration of ALL STAKEHOLDERS. For example, all care givers
must increase awareness of the potential for errors,
administrators must facilitate systems of improvement, patients
must be committed to complying with treatment programs,
industry executives must make patient safety improvement a
declared and serious aim by establishing programs with defined
executive responsibility, and lawmakers and regulators must
resist mandates that could stifle innovative problem solving.
2. LA holistic quality assessment system must be developed and
adopted for use in health care. Individuals are not the true
source of errors in health care or any other industry. Systemic
review of processes, practices and policies to uncover sources
of error so the source of those errors can be eliminated is
essential for improving safety in the health system. The health
care system should incorporate the lessons learned in other
industries that have greatly reduced their error rates.
3. LSafe practice standards should be evidence-based, flexible
and feasible. Nationally recognized safe-practice standards
should be developed only through analysis of conclusive data on
broad-based effectiveness and feasibility, and should consider
evolving science. In addition to recognizing broad-based safe
practices, health care organizations should be encouraged to
and should be recognized for adopting tailored safe practice
programs unique to their specific risk points, specialties, and
patient populations.
4. LHealthcare organizations, lawmakers, and other policy
officials should support the automation of patient safety
systems to the greatest extent possible. The Institute of
Medicine is urging a new generation of patient safety systems
that are automated, information system-based, and
technologically driven. A voluntary health system information
technology infrastructure should be encouraged and facilitated
as broadly and rapidly as possible to help reduce incidence of
human error in the practice of medicine.
5. LEstablish a culture of awareness_NOT blame_to drive health
care errors into the open. Improving patient safety depends
heavily on the ability to collect and analyze patient safety
data, and to use that information to develop safer systems.
Laws that perpetuate litigation are antithetical to the goal of
transforming medical adverse events and ``near misses'' to
permanent and pervasive systems improvements. Lawmakers should
carefully consider any new laws or regulations that could
actually do damage to the current health care system by making
errors and ``near misses'' even harder to identify. Peer review
protections should be instituted to protect organizations from
the fear of litigation which will prevent the sharing of
information.
6. LA system of incentives is the key to patient safety. Using
positive incentives to encourage health care organizations and
all care providers to swiftly report health care delivery
problems and to develop processes and procedures to prevent
further errors in the area is the key to improving the safety
of health care system.
7. LFocus on prevention instead of errors. Instead of devoting
major efforts to medical errors after the fact, develop a
system focused on studying near misses, to prevent adverse
events in the first place. This focus should be firmly
impressed early on in graduate medical education programs as
well as training programs for all types of health care
professionals.
8. LConsider the larger context. The cause of--and solutions
for--adverse medical events must be considered in full context
beyond the individual incidents that result in medical errors:
LA hyper-regulated health care environment is
not conducive to patient safety. Coping with more than
111,000 pages of complex Medicare rules, guidelines and
instructions reduces the amount of time and attention
left for providers to focus on their patients.
LA litigious health care environment is not
conducive to the promotion of awareness and information
sharing necessary to understand and avoid medical
errors.
LA price-controlled health care environment
reduces the ability for health care organizations and
systems to implement the necessary technology that can
positively affect patient safety.
There is no question that the health care industry as a whole must
continue working toward a zero-error environment. Such an environment
will require the devoted, thoughtful collaboration of everyone,
including lawmakers, providers, health systems and patients. Numerous
solutions should be considered before implementing any that could
hinder the creation of a safer health care environment. HLC is
committed to working with Congress to ensure the highest standards for
health care for all Americans. We look forward to working on this
important health policy issue in the coming months.
Statement of Premier, Inc.
Premier, Inc., an alliance of leading not-for-profit hospitals and
health systems, appreciates this opportunity to share our perspectives
on healthcare quality, patient safety, and adverse medical events.
There is, perhaps, no issue of greater import in the healthcare arena
than the sustained improvement of care quality and reduction of
systemic error. We thank the House Ways and Means Health Subcommittee
Chairwoman Nancy Johnson (R-CT) and Ranking Member Pete Stark (D-CA)
for holding today's hearing.
Public policy debate in the immediate wake of the 1999 Institute of
Medicine (IOM) report, To Err is Human: Building a Safer Health System,
coalesced around the controversial notion of mandatory versus voluntary
reporting of medical errors and adverse drug events. Subsequent
discussion was diverted from rhetorical, litigious finger-pointing and
individual blame in favor of more pointed analysis of systemic
shortcomings and cultural reform.
As much testimony offered today has echoed, Premier strongly
believes that caregivers ought to be encouraged to share medical error
and patient safety information without reprisal in a voluntary, non-
punitive environment that puts a premium on information sharing. In the
drive for sustained adverse medical event reduction, the importance of
education and lessons learned cannot be overstated.
Numerous public and private organizations have engaged in
campaigns, programs, and initiatives to foster these changes. The
National Quality Forum (NQF), of which Premier is a member, is a
public-private partnership charged with developing and implementing a
national strategy for healthcare quality measurement and reporting. A
current NQF project is aimed at generating consensus on a core set of
patient safety measurements, with respect to avoidable adverse events
in hospital care. The core measure set will enable standardized data
collection and event reporting within and across states.
The Department of Health and Human Services' Agency for Health Care
Research and Quality (AHRQ), with which Premier collaborates, supports
medical error reporting demonstration projects, and the deployment of
new and emerging information and patient safety technologies for the
reduction of adverse events.
Premier supports legislative remedies to provide hospitals with the
financial assistance necessary to offset the prohibitively high costs
of acquiring and deploying patient safety and information technologies.
By doing just that, the Medical Error Reduction Act (HR. 3292),
introduced last year by Ways and Means Committee Members Amo Houghton
(R-NY) and Karen Thurman (D-FL), would go a long way toward the
achievement of a much-shared goal--the sustained improvement of
healthcare quality and safety. We would note that similar bipartisan
legislation (S. 824) has been introduced by Sens. Bob Graham (D-FL) and
Olympia Snowe (R-ME).
HR. 3292 would authorize grants to facilitate hospitals' and
nursing homes' purchase and development of technologies designed to
reduce medication-related injury. The legislation is supported by a
wide array of businesses, healthcare companies, labor organizations,
and hospital groups (listed below). In addition, HR. 3292 emphasizes
the value of health informatics programs, and encourages hospitals and
other providers to establish health information technology advisory
boards. A minimum of twenty percent of the grant funding in HR. 3292
would benefit rural providers.
Legislation is but one piece of the healthcare quality and patient
safety puzzle. Premier and its member health systems have developed and
continue to expand upon comparative databases of clinical, financial,
and operational metrics at the provider level. Such databases allow
hospitals to compare their performance against that of others, and to
determine areas for measured improvement. The 1999 Institute of
Medicine (IOM) report concludes that the core problem in healthcare
service delivery is not that the individuals within those settings are
not working hard enough. Rather, the report argued, we must develop
systems to facilitate improvement. Premier's informatics databases were
built with such solutions in mind.
The Premier Safety Institute, meanwhile, an alliance-wide
initiative, integrates the safety-related activities of members,
service units, business partners, and communities. These include the
identification of safety-focused products, equipment, and services; the
provision of training, educational resources, and clinical and
technical information; and the fostering of opportunities for
networking and collaboration. Premier's on-going medication management
clinical performance initiative (CPI), for example, integrates new and
existing projects to improve patient outcomes by measurably reducing
adverse drug events (ADEs) and supporting drug utilization
improvements. The aim of this collaborative is to improve patient
safety by reducing the average number of preventable ADEs at
participating hospitals by 50 percent by June 2004.
Premier also champions industry adoption of the Universal Product
Number (UPN) and accompanying bar code technology for the standard
identification and tracking of hospital-administered drugs, biologicals
and devices, as yet another innovative strategy for improving patient
safety. HHS Secretary Tommy Thompson echoed this sentiment at a Senate
hearing last year, telling lawmakers that ``much like grocers use
barcodes, caregivers can use UPNs to track and dispense medications and
reduce simple human errors.''
Attached to this document, please find the commentary of Premier
President and CEO Richard Norling, as published in the Feb. 18, 2002
edition of Modern Healthcare. It offers additional insight into
Premier's quality and safety improvement philosophy, and details about
its initiatives. Again, we appreciate this opportunity to offer a
statement for the record on an issue of such paramount importance.
______
Supporters of HR. 3292, the Medical Error Reduction Act
IBM
Daimler Chrysler
Siemens Vanderbilt University Medical Center
AFL-CIO
McKesson
Newt Gingrich
Aetna
National Rural Health Association
Premier
New York Presbyterian
Federation of American Hospitals
Joint Commission on Accreditation of Healthcare Organizations
VHA Inc.
eHealth Initiative
Verizon
Greater New York Hospital Association
National Association of Children's Hospitals
Florida Hospital Association
Cerner Corporation
David W. Bates, M.D.
BD
3M
EDS
Statement of Donald Rucker, M.D., Siemens Medical Solutions Health
Services Corporation, Malvern, Pennsylvania
I am pleased to submit this testimony on behalf of Siemens Medical
Solutions Health Services Corporation(Siemens) to the Subcommittee on
Health, House Committee on Ways and Means, on the subject of improving
health quality through reductions in medical errors and enhanced
patient safety. Siemens is the leading provider of information systems
and services to the healthcare industry and is the also the industry's
leading application service provider, hosting applications for over
1,000 healthcare institutions from our Malvern, PA--based center, the
largest data processing center for healthcare
The impact of medication errors and their associated costs is
stunning, and by now well documented. The Institute of Medicine (IOM)
study, To Err is Human,\1\ compares the death of 6,000 Americans
annually from workplace inquiries with the impact of medication errors
that account for over 7,000 deaths annually. According to a study
conducted by Bates, et al, at two prestigious medical centers, two out
of 100 admissions experienced a preventable drug event that resulted in
average increased hospital costs of $4,700 per admission \2\ This is
equivalent to $2.8 million annually for a 700-bed teaching hospital.
The IOM study provides an extrapolation associating this volume with $2
billion in increased hospital costs from adverse drug events alone,
even without considering other patient safety concerns such as
nosocomial infections, surgical misadventures, patient falls, and
myriad costly events that pose risk.
---------------------------------------------------------------------------
\1\ To Err is Human--Building a Safer Health System, Kohn, et al,
p. 1, 1999.
\2\ Bates D., et.al. JAMA, The Costs of Adverse Drug Events in
Hospitalized Patients, 277:307-311, 1997.
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The IOM's second report, Crossing the Quality Chasm, provided a
call to action to providers, government, consumers, employers and
payers, and accrediting bodies to make changes to the health system to
improve efficiency, quality and safety.\3\
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\3\ Institute of Medicine. Crosssing the Quality Chasm: a new
health system for the 21st century. Washington, D.C.
National Academy Press, 2001.
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Technology has been recommended as one of the solutions to the
problem of too many medical errors. The Leapfrog Group has led the
charge to implement computerized physician order entry for the intent
purpose of reducing medication errors.\4\ While computerized physician
order entry can be used to address medication errors, we believe that
physician order entry is most effectively deployed when being used to
address the quality, efficiency, and effectiveness of all care, not
just medications. This approach allows the health system to benefit
from the computer-based patient record or CPR.
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\4\ Leapfroggroup.org
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For addressing the full spectrum of medication errors, Siemens
recommends addressing the entire medication use process. According to
data compiled by Agency for Healthcare Research and Quality (AHRQ), 39-
49% of the medication errors occur while ordering medications, and 26-
38% occur during administration.\5\ Siemens customers have achieved
favorable results with technology that addresses both the ordering and
administration of medications. Each system provides another layer of
double checks. While the technology provides an important role in
aiding the performance of the doctors, nurses and pharmacists, it does
not replace these clinicians. In fact, the true benefits of the
technology comes from the ability of the clinicians to re-engineer or
re-structure their workflow, improve communication, streamline
processes, facilitate care, and to focus on clinical decisions.
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\5\ Reducing and Preventing Adverse Drug Events to Decrease
Hospital Costs. Research in Action, Issue 1. AHRQ Publication Number
01-0020, March 2001. Rockville, MD, USA.
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Siemens customers have experienced and measured significant
reductions in errors and costs through the use of its clinical
information systems. The benefits range from clearly quantifiable
financial measures to other benefits that have a softer cost
relationship.
Reductions in errors
Danville Regional Health System (Danville, VA) provides an example
of how medication errors are prevented using bar code scanning and an
electronic medication administration record that is integrated into the
CPR. Danville presented data at the Siemens user group meeting
September 9-12, 2001 and during a vendor showcase presentation at the
American Society of Health-system Pharmacists meeting in December 2001
about their outcomes using Siemens Med Administration Check. This
system uses bar code scanning at the point of care to help ensure that
the right patient receives the right drug at the right dose, via the
right route, at the right time. The system alerts nurses whenever a
drug is past due, or that the nurse is attempting to administer a drug
that does not match the order, or that the patient is not the intended
patient. The hospital has been preventing on average 12 errors per
month. Mary Washington Hospital, part of Medicorp (Fredericksburg, VA)
also presented data at the September and December meetings. They
indicated, using their language, that they were making on average 71
saves per week with the system. They defined a save as any of the
following activities; scanning the wrong drug or patient, a drug that
was scanned too early, or when nursing used the send message function
to alert pharmacy to a problem with either the order or the drugs
delivered. This averaged out to be 22 wrong medications scanned, 13
drugs scanned early, and 30 messages sent to pharmacy per week.
When looking at medication errors, transcription errors are
accountable for 11%-12% of the mishaps.\6\ The Ohio State University
Health System has documented that using computerized physician order
entry they have eliminated transcription errors.\7\ With 100% of all
orders being entered into the computer system directly by physicians,
there is no more illegible handwriting for nurses and clerks to
decipher. Kingsbrook Jewish Medical Center in Brooklyn New York is
another facility that has 100% of all orders placed directly by
physicians into the computerized physician order entry system.
Kingsbrook has also eliminated all verbal orders and telephone
orders.\8\
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\6\ Reducing and Preventing Adverse Drug Events to Decrease
Hospital Costs. Research in Action, Issue 1. AHRQ Publication Number
01-0020, March 2001. Rockville, MD, USA.
\7\ Mekhjian HS, et. al. Immediate Benefits Realized Following the
Implementation of Physician Order Entry at an Academic Medical center.
JAMIA (In Publication for 2002)
\8\ HIMSS 2002 Session 127 Can Physician Order Entry and Physician
Alignment / Satisfaction Coexist?
---------------------------------------------------------------------------
Siemens is actively involved in furthering research into the
effectiveness of information technology in reducing medical errors, not
only in the inpatient setting, but in the ambulatory setting as well.
Along with Denver Health and Micromedex, Siemens is conducting one of
the first outpatient studies examining the feasibility of technology to
improve patient safety when healthcare providers order medications.
Denver Health's study of Medical Logic Modules (MLM) content and CPOE
technology will focus on preventing drug-induced hyper--and
hypokalemia, drug-induced nephrotoxicity, and drug-induced
thrombocytopenia. The 18-month study began January 1, 2002 and is being
funded by a grant from AHRQ.
Reduction in order cycle time
The order cycle time is the time from when an order is placed by
the physician to the time that the patient receives the prescribed
treatment or test. The order cycle time in a manual process can be many
hours and involve many administrative tasks. From the time the
physician writes the order to the time that the patient receives the
ordered service, the paper order will have gone through many hands and
transformations over several hours. Steps in the process would
typically include transcription to the chart, delivery to the
department that needs to perform the service, transcription into a
departmental information system (such as a laboratory or pharmacy
information system), calling the physician for clarifications or
corrections, scheduling the test or procedure, processing, and
documenting the results, and sending the results back to the patient's
chart. With computerized physician order entry the physician enters the
order directly into the computer system. This eliminates the need for
transcription. Clinical decision support within the application
provides alerts and reminders to the physician helping ensure that the
order does not have any clinical conflicts and will not need future
correction by the pharmacy or laboratory. This helps to reduce the
number of times clinicians have to search for the physician to get
clarification or signature for changes. Electronic interfaces eliminate
the need for couriers or pneumatics tubes to transport the orders to
the departments. The time from the physician placing the order to the
time that the order is received in the department is seconds not hours.
When the tests are complete, the results are then entered into the
computer system and immediately available for the physician. Too often
the test is finished but the physician does not have the necessary
information because the results have not made their way back to the
chart, or the physician is not where the chart is located. Electronic
access provides physicians instant access from anywhere.
The shorter the order cycle time, the faster the patient can start
receiving the desired therapeutic benefits. If an antibiotic is to be
given once every six hours, and the drug takes six hours to get to the
patient, then the patient would have missed one dose. This can be a
significant delay in treatment, which in some cases can be significant
in allowing the underlying illness to progress further prolonging
treatment. The longer a patient is in the hospital the chances of them
experiencing a nosocomial infection or other adverse event increases.
Thus reducing cycle time reduces this risk. The reduced cycle time also
facilitates the reduction in patient length of stay.
Several Siemens customers have documented significant reductions in
order cycle time. The Ohio State University Health System showed
reductions of 25% for laboratory orders, 43% for radiology orders, and
64% for pharmacy orders.\9\ The pharmacy cycle times went from 5:28
hours down to 1:51 hours. Radiology procedures were finished almost 3
hours faster from 7:37 hours pre-computerized physician order entry to
4:21 hours with computerized physician order entry (CPOE). The
reduction in laboratory cycle time ranged from 31 to 23 minutes. Rush-
Presbyterian St. Lukes Medical Center in Chicago IL reported an average
pre-CPOE medication order cycle time of 3:49 hours and post-CPOE time
of 1:23 hours.\10\ This is a 64% reduction.
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\9\ Mekhjian HS, et. al. Immediate benefits realized following the
implementation of physician order entry at an academic medical center.
JAMIA (In Publication for 2002)
\10\ Skarulis P, Brill J., Lehman M. HIMSS 2002 Session 126 Rush
Physician Order Entry: From Physician Resistors to Physician Champions.
---------------------------------------------------------------------------
Reduction in cost and length of stay
Computerized physician order entry has the potential to reduce the
cost of care through many mechanisms, while at the same time improving
quality. The reduced cycle time previously referenced helps to reduce
length of stay and, therefore, reduces risk of complications associated
with prolonged hospital stays. CPOE also can help by enabling the
practice of evidence-based guideline driven care. Through the use of
order sets and clinical decision support algorithms, the technology
helps reduce the variance in the care processes. Reducing variance
means that recommended treatments or tests are not forgotten. It means
that pre-procedure or post-procedure processes are conducted in a
consistent manner. This reduces the risk of errors and complications
associated with not following the evidence-based best practice.
The Ohio State University Health System has studied the direct
impact of computerized-physician order entry on cost of care for a
period of 10-12 months pre and post implementation of CPOE.\11\ This
study showed significant reductions in the severity adjusted cost of
care in three out of six care units studied. These reductions were a
7.46% reduction in the Heart unit and a 8.0% reduction in the
Transplant unit of the University Hospital. The James Cancer Hospital's
Surgical Oncology unit had a significant decrease in costs of 7.5%.
These reductions represented savings of between $300 to $600 per stay.
Only one of the six study units had a statistically significant
increase in case mix index adjusted costs, which was 5% in the
Hematology/Oncology unit of the James Cancer Hospital.
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\11\ Mekhjian HS, et. al.
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This same study also looked at the effects on average length of
stay. When all of the services studied were combined for the University
Hospital, there was a statistically significant decrease in the
severity adjusted length of stay from 3.91 days to 3.71 days, and a
reduction from 3.68 days to 3.61 days in the James Cancer Hospital.\12\
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\12\ Mekhjian HS, et. al.
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Other hospitals have shown savings in costs from the use of
clinical decision support systems to direct physicians to less costly
plans of care, but that are equally or more clinically effective.
Kingsbrook Jewish Medical Center is saving $100,000 a year by
restricting the use of high cost antibiotics to only those patients
that have had a consult by an infectious disease specialist.\13\ The
computer system helps to enforce and track the policy. Not only does
this save the hospital in direct costs, it also saves in the reduction
of the over-use of antibiotics. In an unpublished study by Siemens
customer Meridian Health, they were able to identify savings of
$160,000 annually with a reminder that alerted physicians to the
ability to change an intravenous medication to an oral medication when
the patient resumes an oral diet. While they did not address a direct
cost, Rush Presbyterian St. Lukes documented a reduction in Imipenem
resistant bacteria strains in the hospital through their use of
clinical reminders to reduce the over use of antibiotics.\14\ The
spread of antibiotic resistant bacteria adversely affect patient well-
being and the effectiveness of the drug choices available to
physicians. As more powerful drugs are needed to combat resistive
strains, the cost of care increases.
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\13\ Eisenberg, F., Krusch, D., Meindel, N., HIMSS 2002 Session 127
Can Physician Order Entry and Physician Alignment / Satisfaction
Coexist?
\14\ Skarulis P, Brill J., Lehman M HIMSS 2002 Session 126 Rush
Physician Order Entry: From Physician Resistors to Physician Champions.
---------------------------------------------------------------------------
In addition to the direct care costs, some hospitals have
identified other cost savings or re-allocations. Rush Presbyetrian St.
Lukes was able to reduce the amount of expensive multi-part forms that
they purchase and store, as well as reduce clerical staff.\15\ The Ohio
State University Health System was able to re-allocate clerks used for
chart pulls to become medical records coders.\16\
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\15\ Skarulis P, Brill J., Lehman M HIMSS 2002 Session 126 Rush
Physician Order Entry: From Physician resistors to Physician Champions.
\16\ Ahmad, A. POE Enterprise Roadmap Strategies and Benefits
Realization, presented at Physician Order Entry ``Best Practice''
Planning and Implementation Strategies. February 28, 2002. Columbus OH
---------------------------------------------------------------------------
Compliance with documentation and best practice guidelines
Rush Presbyterian St. Lukes has documented that 100% of all
physician-entered orders are now complete and legible when entered. All
of the orders are dated, timed, signed, and most importantly are
legible. This has helped reduce questions about the plan of care for
patients in the hospital. Rush has also used Siemens INVISION
health information system to ensure that physicians properly document
the specific reasons that certain tests are ordered. For radiology
tests, the system makes it easier for the physician to enter the
specific reason for a study rather than entering a generic ``rule/out''
comment. Without a more specific reason documented, the hospital needs
to go through extra steps to locate the physician and obtain the
reason. Insurance claims with non-specific reasons are rejected. By
collecting the specific reason at the time of ordering, claims become
more accurate, and redundant work is eliminated. The results observed
at Rush were a reduction in ``rule/out'' reasons from 30% of all
radiology orders down to 8%.\17\
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\17\ Skarulis P, Brill J., Lehman M HIMSS 2002 Session 126 Rush
Physician Order Entry: From Physician Resistors to Physician Champions.
---------------------------------------------------------------------------
Rush Presbyterian also demonstrated the ability of the CPOE system
to positively affect the physician's ordering behavior to follow best
practice clinical guidelines. Blood culture results are more accurate
when two or three cultures are run within a 24-hour period instead of
just one. The ability to get a more accurate result in the long run
enables the physician to diagnose the patient more accurately and
quickly. Through a simple on screen reminder, Rush changed their double
culture orders from 39.8% to 57%.\18\ Other forms of education were
unsuccessful in changing physician behavior as evidenced by a lack of
ordering practice change in physicians that were not entering orders
directly into the computer system.
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\18\ Skarulis P, Brill J., Lehman M HIMSS 2002 Session 126 Rush
Physician Order Entry: From Physician Resistors to Physician Champions
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Other Benefits
When FDA recalled Rezulin in March 2000, Kingsbrook Jewish Medical
Center was able to search the orders of 800 active patients and remove
Rezulin use from those taking it within hours of the announcement.\19\
The speed in being able to identify affected patients, take action, and
minimally impact staff was only possible from the use of the
computerized system.
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\19\ Meindel N. User Summit 2001, Washington DC
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Conclusion
Again, we appreciate the opportunity to submit testimony on this
important topic. Expanding hospitals' use of use of computerized
patient records will further help to improve the quality of care and
reduce errors. Siemens customers have been able to show that these
systems meet the objectives of improving efficiency, effectiveness, and
safety. Further gains will be achieved as care models move to evidence-
based best care practices. The computer-based patient record helps to
facilitate these process changes. Technologies such as computerized
physician order entry, point-of-care bar code scanning for medication
quality checking, and clinical decision support systems enable
clinicians to concentrate on making the right decisions instead of
searching for the right information.
______
Attachment 1 Summary of Siemens Customer Realized Computerized Physician
Order Entry Benefits
------------------------------------------------------------------------
POE Outcome Siemens Solution Proven Outcomes
------------------------------------------------------------------------
Reduction in Turn Electronic The Ohio State University
Around Time transmission of Health System
orders to 25% reduction in Lab order
departments. cycle time
Orders 43% reduction in Radiology
complete when cycle time
written 64% reduction in medication
Process cycle time
standardization Rush Presbyterian St. Lukes
Improved 64% reduction in medication
access to patient cycle time
information Meridian Health System
84% reduction in medication
cycle time
------------------------------------------------------------------------
Reduction in Cost Order sets The Ohio State University
Reduction of Process Health System
variance in care standardization 7.5% to 8% reductions for
several services
Rush Presbyterian St. Lukes
Reduction in multi-part forms
Elimination of Unit Clerks
------------------------------------------------------------------------
Reduction in Length Order sets The Ohio State University
of Stay Process Health System
standardization 1.9% to 5.1% reduction in
length of stay
------------------------------------------------------------------------
Increase compliance Alerts and Rush Presbyterian St. Lukes
with best practice reminders Increase compliance with
protocols blood culture order
procedure up from 39.8% to
57%. (Physicians using paper
at same time did not change)
------------------------------------------------------------------------
Reduction in errors Forcing The Ohio State University
functions Health System
Ability to 100% elimination of
enforce policy transcription errors
through log-ons 50% reduction of medication
errors
Kingsbrook Jewish Medical
Center
100% eliminated verbal and
telephone orders
------------------------------------------------------------------------
Improve Forcing The Ohio State University
documentation functions within Health System
compliance workflow Verbal order cosignature
compliance rate up from
72.8% to 98.95%
Rush Presbyterian St. Lukes
100% of orders entered
directly by physician are
dated, timed, signed, and
legible
------------------------------------------------------------------------
Reduce insurance Provide Rush Presbyterian St. Lukes
claims rejections alerts Radilogy order reason, made
Drop down it easier to provide an
selections make it accurate exam reason,
easy to complete instead of ``rule/out'', the
documentation. rate of stated reasons of
``rule/out'' dropped from
30% of all radiology orders
to only 8%.
------------------------------------------------------------------------
Speed patient Search and Kingsbrook Jewish Medical
notification of report against Center
recalls enterprise patient Within hours of FDA recall
list notice, searched 800 active
patients and discontinued
affected drug.
------------------------------------------------------------------------
Reduced use of Online Rush Presbyterian St. Lukes
overused clinical alerts Imipenem resistance dropped
antibiotics from 50% to 15%
------------------------------------------------------------------------
Resource re- The Ohio State University
allocation Health System
FTE directed to chart reviews
per-POE was promoted to a
coder
Rush Presbyterian St. Lukes
Eliminated unit clerk
positions
------------------------------------------------------------------------