[House Hearing, 107 Congress]
[From the U.S. Government Publishing Office]



                               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

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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
RON LEWIS, Kentucky
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

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 
printed and electronic versions of the hearing record, the process of 
converting between various electronic formats may introduce 
unintentional errors or omissions. Such occurrences are inherent in the 
current publication process and should diminish as the process is 
further refined.

                            C O N T E N T S

Advisory of February 27, 2002, announcing the hearing............     2


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



                        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:]



                         SUBCOMMITTEE ON HEALTH

                                                CONTACT: (202) 225-3943
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.


    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.''


    Thursday's hearing will focus on improving health quality through 
reductions in medical errors and enhanced patient safety.


    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 
200 copies to the Subcommittee on Health in room 1136 Longworth House 
Office Building, in an open and searchable package 48 hours before the 
hearing. The U.S. Capitol Police will refuse unopened and unsearchable 
deliveries to all House Office Buildings.


    Each statement presented for printing to the Committee by a 
witness, any written statement or exhibit submitted for the printed 
record or any written comments in response to a request for written 
comments must conform to the guidelines listed below. Any statement or 
exhibit not in compliance with these guidelines will not be printed, 
but will be maintained in the Committee files for review and use by the 
    1. Due to the change in House mail policy, all statements and any 
accompanying exhibits for printing must be submitted electronically to 
mailto:[email protected], along with a fax copy to (202) 
225-2610, in Word Perfect or MS Word format and MUST NOT exceed a total 
of 10 pages including attachments. Witnesses are advised that the 
Committee will rely on electronic submissions for printing the official 
hearing record.
    2. Copies of whole documents submitted as exhibit material will not 
be accepted for printing. Instead, exhibit material should be 
referenced and quoted or paraphrased. All exhibit material not meeting 
these specifications will be maintained in the Committee files for 
review and use by the Committee.
    3. A witness appearing at a public hearing, or submitting a 
statement for the record of a public hearing, or submitting written 
comments in response to a published request for comments by the 
Committee, must include on his statement or submission a list of all 
clients, persons, or organizations on whose behalf the witness appears.

    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 
special accommodation needs in general (including availability of 
Committee materials in alternative formats) may be directed to the 
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 
    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 
    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 
    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 
    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.


    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 
    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 
    [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 
    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.


    Dr. MILLER. Madam Chairman, I am the Vice President of 
Medical Affairs----
    Chairman JOHNSON. You have to get very close to these 
    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 
    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 
    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.
    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 
    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.
    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 
    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.
    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 
    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 
    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.
    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.

                     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 
    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 
    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 
    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 
    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 
           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 
           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 

    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 
    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 

        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 

        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 

        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 


    Chairman JOHNSON. Thank you very much.
    Ms. Foley, President of the 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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
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.
    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.


    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 
    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 
    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 
    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 
    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 
         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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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

    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 

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 

Additional Principles That Need to Be Incorporated into Patient Safety 

    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
    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.

    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 
    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 
    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 
    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 

    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 

           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 

        (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 

        (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 
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 
    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 
    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 

           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 
           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 
           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.

    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.
    Attachment: Principles of Patient Safety in Pediatrics, AAP Policy 


                            Policy Statement

Volume 107, Number 6
June 2001, pp. 1473-1475
Principles of Patient Safety in Pediatrics (RE060027)

    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 
    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.
    \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; 
    \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).
    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.


          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 
          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 
          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 
                   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.
        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.
          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; 
                   LSupport expanded efforts to include 
                children in new drug trials.
          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 
                   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 

    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.

(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 
    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 
    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%
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.

    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 

                    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 
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 
    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.

    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 


    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:

    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.

    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 
          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 

    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 
    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 

    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 
    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 

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 
    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 

    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 
    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 
           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 
           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 
    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
    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 
           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 

    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 

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 
    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 
    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.
    \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.
    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.
    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 
        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 
        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 
                 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

Daimler Chrysler
Siemens Vanderbilt University Medical Center
Newt Gingrich
National Rural Health Association
New York Presbyterian
Federation of American Hospitals
Joint Commission on Accreditation of Healthcare Organizations
VHA Inc.
eHealth Initiative
Greater New York Hospital Association
National Association of Children's Hospitals
Florida Hospital Association
Cerner Corporation
David W. Bates, M.D.


  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.
    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\
    \3\ Institute of Medicine. Crosssing the Quality Chasm: a new 
health system for the 21st century. Washington, D.C. 
National Academy Press, 2001.
    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.
    \4\ Leapfroggroup.org
    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.
    \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.
    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 
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 
    \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.
    \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.
    \11\ Mekhjian HS, et. al.
    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\
    \12\ Mekhjian HS, et. al.
    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.
    \13\ Eisenberg, F., Krusch, D., Meindel, N., HIMSS 2002 Session 127 
Can Physician Order Entry and Physician Alignment / Satisfaction 
    \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\
    \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\
    \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.
    \18\ Skarulis P, Brill J., Lehman M HIMSS 2002 Session 126 Rush 
Physician Order Entry: From Physician Resistors to Physician Champions
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.
    \19\ Meindel N. User Summit 2001, Washington DC
    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
                                           Kingsbrook Jewish Medical
                                           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
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
                                           Rush Presbyterian St. Lukes
                                           Eliminated unit clerk