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81–751 2002

HEALTH QUALITY AND MEDICAL ERRORS

HEARING

BEFORE THE

SUBCOMMITTEE ON HEALTH

OF THE

COMMITTEE ON WAYS AND MEANS 

HOUSE OF REPRESENTATIVES

ONE HUNDRED SEVENTH CONGRESS

SECOND SESSION

MARCH 7, 2002

Serial No. 107–76

Printed for the use of the Committee on Ways and Means

(

ii

COMMITTEE ON WAYS AND MEANS

BILL THOMAS, California, Chairman

PHILIP M. CRANE, Illinois 

E. CLAY SHAW, JR., Florida 

NANCY L. JOHNSON, Connecticut 

AMO HOUGHTON, New York 

WALLY HERGER, California 

JIM MCCRERY, Louisiana 

DAVE CAMP, Michigan 

JIM RAMSTAD, Minnesota 

JIM NUSSLE, Iowa 

SAM JOHNSON, Texas 

JENNIFER DUNN, Washington 

MAC COLLINS, Georgia 

ROB PORTMAN, Ohio 

PHIL ENGLISH, Pennsylvania 

WES WATKINS, Oklahoma 

J.D. HAYWORTH, Arizona 

JERRY WELLER, Illinois 

KENNY C. HULSHOF, Missouri 

SCOTT MCINNIS, Colorado 

RON LEWIS, Kentucky 

MARK FOLEY, Florida 

KEVIN BRADY, Texas 

PAUL RYAN, Wisconsin 

CHARLES B. RANGEL, New York 

FORTNEY PETE STARK, California 

ROBERT T. MATSUI, California 

WILLIAM J. COYNE, Pennsylvania 

SANDER M. LEVIN, Michigan 

BENJAMIN L. CARDIN, Maryland 

JIM MCDERMOTT, Washington 

GERALD D. KLECZKA, Wisconsin 

JOHN LEWIS, Georgia 

RICHARD E. NEAL, Massachusetts 

MICHAEL R. MCNULTY, New York 

WILLIAM J. JEFFERSON, Louisiana 

JOHN S. TANNER, Tennessee 

XAVIER BECERRA, California 

KAREN L. THURMAN, Florida 

LLOYD DOGGETT, Texas 

EARL POMEROY, North Dakota 

ALLISON GILES, Chief of Staff 

JANICE MAYS, Minority Chief Counsel

SUBCOMMITTEE ON HEALTH

NANCY L. JOHNSON, Connecticut, Chairman

JIM MCCRERY, Louisiana 

PHILIP M. CRANE, Illinois 

SAM JOHNSON, Texas 

DAVE CAMP, Michigan 

JIM RAMSTAD, Minnesota 

PHIL ENGLISH, Pennsylvania 

JENNIFER DUNN, Washington 

FORTNEY PETE STARK, California 

GERALD D. KLECZKA, Wisconsin 

JOHN LEWIS, Georgia 

JIM MCDERMOTT, Washington 

KAREN L. THURMAN, Florida

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. 

iii

C O N T E N T S 

Page 

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

WITNESSES 

American Hospital Association, and Danbury Hospital, Matthew Miller, M.D . 12

American Nurses Association, Mary Foley ............................................................ 23

Institute for Healthcare Improvement, Donald M. Berwick, M.D ....................... 17

Michigan Department of Veterans’ Affairs, Veterans Health Administration, 

James P. Bagian, M.D ......................................................................................... 7

Pittsburgh Regional Healthcare Initiative, and Jewish Healthcare Foundation 

of Pittsburgh, Karen Wolk Feinstein .................................................................. 28

SUBMISSION FOR THE RECORD 

American Academy of Family Physicians, Leawood, KS, statement ................... 43

American Academy of Orthopaedic Surgeons, statement and attachment ......... 45

American Academy of Pediatrics, statement and attachment ............................. 48

American Health Quality Association, David G. Schulke, statement and attachment ............................................................................................................... 54

American Society for Clinical Pathology, statement ............................................. 57

American Society of Health-System Pharmacists, Bethesda, MD, statement .... 58

Cerner Corporation, Trace Devanny, Kansas City, MO, statement .................... 62

College of American Pathologists, statement ........................................................ 63

eHealth Initiative, statement ................................................................................. 65

Healthcare Leadership Council, Mark R. Grealy, statement ............................... 68

Premier, Inc., statement and attachment .............................................................. 70

Siemens Medical Solutions Health Services Corporation, Malvern, PA, Donald 

Rucker, M.D., statement and attachment .......................................................... 71

(1)

HEALTH QUALITY AND MEDICAL ERRORS 

THURSDAY, MARCH 7, 2002

HOUSE OF REPRESENTATIVES, 

COMMITTEE ON WAYS AND MEANS, 

SUBCOMMITTEE ON HEALTH, 

Washington, DC. 

The Subcommittee met, pursuant to notice, at 11:10 a.m., in 

room 1100 Longworth House Office Building, Hon. Nancy L. Johnson (Chairman of the Subcommittee) presiding. 

[The advisory announcing the hearing follows:]

2

ADVISORY

FROM THE COMMITTEE ON WAYS AND MEANS

SUBCOMMITTEE ON HEALTH

FOR IMMEDIATE RELEASE 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.

BACKGROUND:

According to the Institute of Medicine (IOM), fatalities from medical errors are 

estimated to be the eighth leading cause of death in the United States. In 1999, 

IOM’s study To Err is Human: Building a Safer Health System, estimated annual 

deaths from medical errors are at least 44,000 and may be as high as 98,000. The 

number who are injured is higher.

More often than not medical errors occur because of endemic system problems, not 

lack of skill or imprudence. Seniors interact with the medical system more frequently than most because of the potential for accident, injury or death to Medicare 

beneficiaries is more prevalent. As the country’s largest insurer of seniors, Medicare 

has the potential to create processes and adopt technological advances that decrease 

adverse medical events, thereby significantly improving the quality of patient care 

and reducing Medicare costs.

In announcing the hearing, Chairman Johnson stated, ‘‘Medicare patients are 

some of the most vulnerable in the health care system. We must take the opportunity presented by advances in patient care and technology to protect seniors from 

harmful errors and improve the quality of their care. There should be very little disagreement on such a goal, so a bipartisan approach is possible. Here is an area 

where we can revolutionize senior care.’’

FOCUS OF THE HEARING:

Thursday’s hearing will focus on improving health quality through reductions in 

medical errors and enhanced patient safety.

DETAILS FOR SUBMISSION OF WRITTEN COMMENTS:

Please note: Due to the change in House mail policy, any person or organization 

wishing to submit a written statement for the printed record of the hearing should 

send it electronically to A hearingclerks.waysandmeans@mail.house.gov, 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 

3

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.

FORMATTING REQUIREMENTS:

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 Committee. 

1. Due to the change in House mail policy, all statements and any accompanying exhibits for 

printing must be submitted electronically to mailto:hearingclerks@mail.house.gov, 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.

come to order, and while there are a number of other SubChairman JOHNSON. Good morning, everyone. The hearing will 

f committee 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 

4

way, honestly recognizing the lack of malice that is causing such 

errors and the cost of the systems necessary to address them. Systemic approaches to reduce medical errors are endorsed by academicians and practitioners, and have the potential to dramatically 

improve health quality and patient safety while reducing costs. 

The best way to reduce medical errors is to learn from our mistakes, and I would like to just share a short passage from the IOM 

study. One of the report’s main conclusions is that the majority of 

medical errors do not result from individual recklessness or the actions of a particular group. 

This is not a ‘‘bad apple’’ problem. More commonly, errors are 

caused by faulty systems, processes, and conditions that lead people to make mistakes or fail to prevent them. Thus, mistakes can 

best be prevented by designing the health system at all levels to 

make it safer, to make it harder for people do so something wrong 

and easier for them to do things right. 

Reporting adverse events allows us to gain insight into those specific events and to identify patterns or common factors creating errors, changing practices, and preventing future errors. Individuals 

will not disclose their mistakes if they think they are going to be 

embarrassed or harmed. Appropriate legal and confidentiality protections are an essential element of a reporting system that works. 

One common cause of errors is illegible prescriptions, because patients are often given the wrong prescription because the doctor’s 

handwriting is misread. Electronic prescribing has the potential to 

dramatically improve patient compliance with drug regimens, reduce adverse drug interactions, and improve patient health and reduce costs. 

Today we will hear from the Michigan Department of Veterans’ 

Affairs (VA). They have adopted a successful reporting system that 

has improved patient safety. Also, the Pittsburgh Regional Health 

Care Initiative will discuss their success in implementing an ambitious zero tolerance policy for medical errors, and I might add that 

we do have testimony from Secretary O’Neill on this important system and issue, one that he has been very involved in in the past. 

Finally, we will hear from an academic and providers on their perspective to improve health outcomes and patient safety. 

I look forward to the testimony. The solutions to this problem are 

not partisan. Working together, we have the opportunity to literally 

save lives. I look forward to working with my colleagues on the 

Committee to address this issue promptly. 

With that, I would like to recognize Mr. Stark. 

[The opening statement of Chairman Johnson follows:]

Opening Statement of the Hon. Nancy L. Johnson, a Representative in Congress from the State of Connecticut, and Chairman, Subcommittee on 

Health 

Unfortunately, medical errors are an endemic problem that permeates our health 

system. According to the Institute of Medicine (IOM), preventable medical errors are 

the eighth leading cause of death in America, accounting for at least 44,000 and as 

many as 98,000 mortalities in hospitals each year. The number of injured is greater. 

In addition, the IOM also estimated that medical errors in hospitals cost between 

$17 and $29 billion each year. This is simply unacceptable. Patients interact with 

the health system to improve their lives, not endanger them. 

Not only do avoidable patient errors harm patients, they drive up health costs by 

requiring expensive medical interventions to correct the subsequent medical probVerDate Sep 04 2002 01:19 Oct 03, 2002 Jkt 081751 PO 00000 Frm 00008 Fmt 6633 Sfmt 6621 E:\HR\OC\B751.XXX B751
5

lems. 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.

commentary not across the aisle but at the Congress in general and 

Mr. STARK. Madam Chair, thank you, and I want to direct this 

f certainly at the medical care delivery system in particular. 

Once again we are having a hearing. The IOM report came out 

in 1999. We have had hearings. We had a similar hearing to this 

identical hearing in 2000. Here we are, 2 years later, another hearing. I have introduced a bill. I am not sure it is any good, but there 

have been bills introduced to begin the process of setting in place 

a system for systematically reviewing medical errors and setting up 

procedures to prevent them. 

Now, you are going to hear from some people that we should 

have a voluntary industry effort. That is just crap. The Joint Commission on Accreditation of Healthcare Organizations or JCAHO 

isn’t worth a pound of salt. They have never punished a hospital 

that I know of in the existence of their so-called inspections of the 

hospitals. They are paid by the hospital. 

So, unless we are willing to sit down—we went through this 

same thing with needle sticks. The hospitals fought us on safe needles like Billy be-damned until some hospital got sued for $8 or $9 

million and then they said, ‘‘Oh, maybe we should use safe needles.’’ They won’t move unless we move and make it a requirement. 

Tort reform will come up. I think that is nonsense. If somebody 

cuts off the wrong leg, you don’t need a system to tell you that you 

have been harmed, and you are going to sue. If you are too dumb 

6

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 

7

also to better serve people who come out of medical training with 

enormous debts, who are in this business to provide care for people 

who desperately need it. 

Mr. STARK. How about tying it to updates in the Medicare reimbursement, Madam Chair? That might get some action. 

Chairman JOHNSON. You and I have long disagreed on the 

value of mechanical Federal formulas, and if what is happening to 

physicians isn’t evidence that mechanical formulas cause problems, 

I don’t know what is. 

Okay, let’s start. Dr. Bagian, Director of the National Center of 

Patient Safety, the Michigan Department of Veterans’ Affairs, from 

Ann Arbor. Thank you for being with us and for sharing your experience in these areas. 

STATEMENT OF JAMES P. BAGIAN, M.D., P.E., DIRECTOR, NATIONAL CENTER FOR PATIENT SAFETY, VETERANS HEALTH 

ADMINISTRATION, MICHIGAN DEPARTMENT OF VETERANS’ 

AFFAIRS, ANN ARBOR, MICHIGAN 

Dr. BAGIAN. Thank you, Madam Chairwoman, for the opportunity to come here, and Members of the Committee. I thought I 

would share the experience of a little bit of the Michigan VA and 

try to answer some of the questions you just posed in the initial 

remarks here. 

We certainly agree that safety is the foundation upon which 

quality is built. You can’t begin to say you have a quality system 

if you don’t provide safety to the patients. The Michigan VA has 

been very interested and active in patient safety since 1997, almost 

21⁄2 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. 

8

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 

9

close call. We do that, and I have numerous examples where concrete things that had global impact have been detected through 

that. 

We also found in the old systems, 50 percent of the cases that 

would be looked at, people thought were not preventable because 

we didn’t give them good systems tools to look at this, good human 

factors oriented tools. Now 100 percent come back with prevention, 

preventive strategies. That is huge. That means people are thinking differently. We think that is important. 

To get there, though, we had to deal with certain barriers, and 

the barriers were, people were worried about punitive action, and 

that is from their perspective, not from the boss’s perspective. That 

is not just, are you going to get fired, are you going to be suspended? That is are you going to be publicly humiliated, embarrassed? 

All those things count. They are real roadblocks to sharing. We 

have to have protection so people understand that when they are 

not in the blameworthy category, that they can share, because the 

blameworthy ones won’t tell you anyway. You know, if people did 

it deliberately, they are never going to tell you, so you have to have 

your other accountability mechanisms to deal with that. 

Aviation learned this a long time ago with the Aviation Safety 

Reporting System (ASRS), because aviation had this problem. 

There was a crash not 40 miles from where we are sitting right 

now, where 92 souls perished, all because what was learned 6 

weeks prior to that by another crew wasn’t shared because of fear 

of punitive action. The Federal Aviation Administration, FAA, reacted decisively, started, had National Aeronautics and Space Administration (NASA) start the ASRS, and now they have a de-identified, that is not anonymous, reporting to NASA, which then 

shares those vulnerabilities with the community so they can be addressed. 

We have an internal system at the Michigan VA, but we also 

have an external system we have set up that NASA actually runs 

for us, and it allows people to report. Now, I will say that that is 

something that can be used anywhere. We cannot right now, because of confidentiality issues, open it to outside Members, but Kaiser Permanente for instance has approached us and wants to be 

part of it. The U.S. Department of Defense, DOD, does. University 

of Michigan does, Vanderbilt, and on and on and on. 

Until there is legislation which allows people to be able to share 

these things between institutions within a State, and more importantly, across States, they can’t do that, because to share that 

means it is all discoverable, which means people will not report. So 

in the safety realm we need protection if you want people to truly 

be able to share nationally. The Patient Safety Reporting System, 

PSRS, that has already been put in place with NASA, what we 

have done, could easily be opened up to others with the stroke of 

a pen, but without confidentiality protection it cannot happen. So 

we think this is extremely important and necessary and would 

really put it forward so people can share and learn. 

I guess I would leave you with, until now the way we have 

worked in medicine is experience is the best teacher, but it is also 

the most costly teacher, and the people who pay our tuition are the 

10

patients. That is a terrible way to do business. We should really 

learn from each others’ experience and not cause us to learn 

through harm done to others. Thank you. 

[The prepared statement of Dr. Bagian follows:]

Statement of James P. Bagian, M.D., P.E., Director, National Center for Patient Safety, Veterans Health Administration, Michigan Department of 

Veterans’ Affairs, Ann Arbor, Michigan 

Mr. Chairman and Members of the Committee, I am pleased to be here today to 

discuss the significant challenge of improving the safety of health care delivery and 

particularly the approach that VA is taking to address this problem. 

Inadequate patient safety is a critical worldwide problem in healthcare. In the 

U.S., estimates of the lives lost due to factors related to patient safety exceed that 

of the lives lost due to motor vehicle accidents, breast cancer, or AIDS (IOM, To Err 

is Human). In order to reduce medical errors, programs must first identify the underlying causative factors so that they can be understood, and then implement effective preventive strategies. Unfortunately, most healthcare systems and regulators 

have not modified their tactics to focus on prevention. The systematic problems that 

are associated with medical errors and close calls persist; namely the belief that accountability systems and punishment are the primary and most effective means to 

achieve improvement in patient safety. While accountability systems play an important role in health care organizations, they cannot do all things. Albert Einstein 

once observed, ‘‘Insanity: doing the same thing over and over again and expecting 

different results.’’ This is where we seem to currently find many individuals and organizations in their quest for patient safety improvement. Put another way—the 

health care system punishes providers without giving them the tools to improve patient safety. 

An over-reliance on punitive accountability systems is a major stumbling block to 

improvement because it does not encourage identification of potential problems and 

provides disincentives for reporting. This state of events is not peculiar to 

healthcare and has been encountered by other industries. Aviation recognized that 

further improvement in safety could not be achieved by putting in place yet another 

accountability system. Instead they introduced a system whose purpose was learning, whose goal was prevention not punishment, and most importantly was viewed 

as both beneficial and non-punitive by the end-users or those from whom reports 

are sought. Today in medicine there is no dearth of accountability systems but there 

is a scarcity of systems that are viewed as non-punitive reporting systems. 

To address these needs the VA developed and continues to implement an innovative systems approach to prevent harm to patients within VA’s 163 medical centers. 

VA recognized that individual human behavior is seldom the basic reason for medical adverse events—adverse events are usually due to the complex interaction of 

known and unforeseen vulnerabilities in health care delivery. Innovations were necessary, since no one had ever instituted a comprehensive systems-oriented safety 

program for large medical organizations. VA combined lessons from industrial settings such as aviation and nuclear power with the theory and body of knowledge 

from human factors and safety engineering to fashion systems that would better 

contribute to prevention of unintended harm to patients. (Human factors engineering was cited by the 1999 IOM report as the discipline most often overlooked by 

health care when designing safety systems.) 

VA implemented nationwide internal and external reporting systems that supplement the many accountability systems we already had. The new systems’ sole purpose was for organizational learning. They were constructed to encourage maximal 

reporting of even close calls and potential problems with non-punitive methods. This 

was essential because without the ability to identify system vulnerabilities and to 

analyze their root causes for common systematic problems our ability to achieve 

meaningful and sustainable patient safety improvement is limited. One method VA 

employed to better understand how to make these systems optimally function was 

to first do some surveys and focus groups of both VA and external healthcare workers to better understand their concerns and the characteristics that would help 

make our program effective. One point that was clear concerned the issue of punitive measures. Specifically, health care providers’ view of punitive actions extended 

beyond typical administrative punishment to include factors such as shame, embarrassment, and professional reputation. Protection from these factors, was essential 

if we were to receive any reports from which we could then learn and proceed to 

undertake improvement and prevention efforts. This information convincingly demonstrated that confidentiality is pivotal to assuring the non-punitive intent and poVerDate Sep 04 2002 01:19 Oct 03, 2002 Jkt 081751 PO 00000 Frm 00014 Fmt 6633 Sfmt 6621 E:\HR\OC\B751.XXX B751
11

tential 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.’’

f 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 

12

proud of his leadership, as I am of the Connecticut hospital system, 

and have worked very closely with the hospitals in my district because I have hospitals that are very small in rural areas, and hospitals that are superb teaching hospitals. Dr. Miller runs the Danbury Hospital, which is kind of a hybrid of both. It is a teaching 

hospital in a small city, surrounded by relatively small towns but 

on the border with New York and in the New York City environment. 

So it is a pleasure to have you with us, Dr. Miller, and to have 

you share the experience of an institution in trying to grapple with 

these very problems. 

STATEMENT OF MATTHEW MILLER, M.D., VICE PRESIDENT, 

MEDICAL AFFAIRS, DANBURY HOSPITAL, DANBURY, CONNECTICUT, ON BEHALF OF THE AMERICAN HOSPITAL ASSOCIATION 

Dr. MILLER. Madam Chairman, I am the Vice President of Medical Affairs——

Chairman JOHNSON. You have to get very close to these microphones. 

Dr. MILLER. I am the Vice President for Medical Affairs at Danbury Hospital, a community teaching hospital in Danbury, Connecticut. I have worked in health care for 30 years as a practicing 

physician, and for the last 10 years as a physician executive. I am 

here today on behalf of the American Hospital Association (AHA). 

We appreciate the opportunity to present our views on improving 

health care quality and safety. 

We are extremely proud of the initiatives that hospitals and their 

staffs have adopted to improve patient safety. We are eager to work 

in furthering those efforts. I would like to talk about the importance of creating a culture of safety in health care, the role of medical error reporting, and the potential of technology to prevent adverse events. 

We must create a system where medical errors are detected and 

analyzed so that we may learn how to reduce those errors in the 

future. To do this we must, one, provide a nonpunitive environment 

for reporting errors; recognize that most errors are failures of systems, not individuals; investigate errors thoroughly, using root 

cause analyses; and, four, collaborate with experts and peers on the 

lessons learned. 

The AHA supports efforts underway in the Senate to create an 

improved confidential system for the voluntary reporting of patient 

safety information. We hope that this Subcommittee will take a 

similar approach. 

We all agree that reducing medication errors is a critical goal for 

us improve health care safety. We must have systems in place to 

ensure that important clinical information is available to physicians at the time drugs are prescribed, so that orders can be complete and accurate. Effective medication management systems 

must ensure that the right patient is getting the right medication 

at the right time, the right dose. 

New technology can be very helpful in reducing medication errors. Examples include computerized physician order entry, CPOE, 

and bar coding for drug and patient identification. We need to recVerDate Sep 04 2002 01:19 Oct 03, 2002 Jkt 081751 PO 00000 Frm 00016 Fmt 6633 Sfmt 6602 E:\HR\OC\B751.XXX B751
13

ognize, however, that these technologies do not provide a single silver bullet solution to these medication errors. 

With CPOE, physician orders are entered directly into a computer. The computer provides real time patient data, including allergies and lab test results. It also provides pertinent formulary information, standard dosing protocols, and guidelines for care, all in 

one location. I do believe that CPOE systems, when fully implemented, have extraordinary potential to prevent errors. 

We have begun implementing CPOE at Danbury Hospital, but 

the road will be long and arduous. We cannot discount a number 

of other very important considerations. One, CPOE is expensive. We will need at least $2.5 million over 

the next 2 years, and we are getting off cheap because we had already purchased a system. Other comparably sized hospitals to 

mine will spend $5 to $10 million, and that doesn’t include maintenance. 

The CPOE is fairly new, not widely tested beyond large academic 

medical centers with homegrown systems. 

Three, there is no off-the-shelf package ready to install. The 

CPOE requires substantial customization. 

Four, CPOE systems must interface with other hospital information systems. We, for example, just discovered a problem with our 

pharmacy system. We will have to change that system entirely. 

Five, staff support for implementation will be huge, involving 

physicians, pharmacy, nursing, information technology. Not all hospitals have those resources either for implementation or for maintenance, and ultimately, education of all the staff and major work 

redesign will be necessary to achieve all the planned goals. 

We can’t forget that there are multiple other medication management strategies that hospitals can and, in fact, must implement 

first, such as standardized orders, practice guidelines, formulary 

control, computerized access to clinical information. These strategies can accomplish a lot and they are actually much easier to implement. 

Bar code technology is another tool to prevent medication errors. 

The AHA is very supportive of efforts underway at the Food and 

Drug Administration or FDA to promulgate bar code regulation 

that will enable information systems to verify correct patient medication and dose. 

It is important to understand this issue against a backdrop of 

larger health care environment. Hospitals are facing unprecedented 

pressures, including a severe work force shortage, soaring pharmaceutical prices, and increased professional liability costs. 

In conclusion, a third of all hospitals are operating in the red 

today and another third are teetering on the edge. It is vital that 

hospitals have adequate resources to meet the needs of their communities, and for this reason we are asking Congress to forego 

budget neutral provider payment adjustments; approve the full 

Medicare inpatient inflation update; protect Indirect Medical Education or IME payments; and help find a solution for the nearly 40 

million uninsured. We look forward to working with Congress and 

others to help us cross what has been called a quality chasm. 

I would be happy to answer any questions. 

[The prepared statement of Dr. Miller follows:]

14

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-theart 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-theart cancer center. The hospital is recognized as a regional referral center and as the 

community health center for Danbury and the surrounding areas. 

I have spent most of my 30-year career in health care as a practicing 

pulmonologist and physician executive. As Vice President for Medical Affairs I have 

administrative responsibility for clinical quality and safety, utilization of clinical resources, risk management, medical staff credentialing, regulatory compliance, and 

medical staff liaison functions. It is with this experience that I come before you 

today to discuss medical errors, how technology can help reduce those errors, and 

the role that hospitals play in improving patient safety through these initiatives. 

Madame Chairman, I would like to state, on behalf of the entire hospital community, how proud we are of the initiatives that hospitals and our staffs have already 

adopted to improve patient safety. We look forward to working with you in the future as we continue to enhance our safety policies so that we minimize errors and 

continuously improve our care. This hearing gives all of us testifying before you 

today an opportunity to share our insights with you, and with each other, so that 

together we can reduce medical errors. As I’m sure my colleagues will agree, improving health quality and patient care is a team effort and we stand ready to do 

our part. 

CREATING A CULTURE OF SAFETY 

Hundreds of times a day, every day in today’s hospitals, health care is provided 

through a complex system that involves people, technology, medical devices, and 

pharmaceuticals. This complexity has mushroomed in the past decade. Preventing 

and reducing errors is therefore a very complicated task that never ceases. Every 

medical error, whether or not it causes harm to a patient, must be detected and 

analyzed systematically in order to improve our ability to prevent these errors. 

To prevent errors, we must create a culture of safety. Most of what has been 

learned in recent years about how to reduce errors and improve patient safety is 

based on two guiding principles. First, human beings, by their very nature, are vulnerable to error. Although the individuals involved are sometimes the focus after 

an error occurs, we know that errors most often occur because of failures in the systems in which individuals work. As a result, reducing medical errors will require 

us to develop and re-design the delivery of health care to build in error-resistant 

systems. 

Second, we must create an environment in which we learn from our mistakes. As 

a first step, we have to develop effective mechanisms for candid discussion of errors, 

something that cannot be achieved in an environment of punishment or fear. Physicians, nurses, and other caregivers should not be penalized for stepping forward 

after a mistake has been made to report their error or an error they observed. We 

need to create supportive systems both within health care organizations and 

through specific legal reforms. 

Today, when health care providers share confidential internal information with 

health care oversight agencies, other hospitals, or outside experts, they may jeopardize the protection that state laws provide to internal quality analysis discussions 

and expose the institution and caregivers to crushing legal liabilities. This legal 

‘‘Catch 22’’ impedes efforts to share critical safety and quality information and analysis to prevent similar events from happening. It is essential that carefully constructed federal confidentiality and evidentiary legal protections be developed to encourage a culture of safety based on candor and learning. Further, reporting must 

be standardized and carefully defined. 

15

1Leape LL, Bates DW, Cullen DJ et all. Systems Analysis of Adverse Drug Events. JAMA 

1995; 274:35–43. 

The AHA continues to support federal legislation to address this issue. In the Senate, there is an effort underway to address how the Congress could create an improved system for the voluntary sharing of patient safety information both with external experts and across health care delivery sites with adequate confidentiality 

protections. We hope that this subcommittee will consider a similar approach in addressing health care safety issues. It is vital that the Congress enact legislation that 

protects the analysis and sharing of adverse event and other patient safety information so that caregivers can uncover, analyze, and share their experiences and learning, without fear of reprisal. 

At Danbury Hospital, we are committed to creating a culture of safety. We have 

put in place a non-punitive reporting system that relies on intensive safety, education, and quality training. We scrutinize any adverse event to understand the 

cause so that we can change our systems to prevent similar occurrences. Further, 

we are committed to using new technologies that will improve patient care. 

THE POTENTIAL OF NEW TECHNOLOGIES

Medication errors are a critical concern for health care. We know from the research that roughly two-thirds of medication errors, those that reach or don’t reach 

the patient, occur in physician ordering and administration.1 We must have systems 

in place to make sure that important clinical information is available to physicians 

and pharmacists at the time drugs are prescribed. Further, we must build systems 

that make sure the right patient is getting the right medication and dose at the 

right time. 

There is extraordinary promise in reducing medication errors by using technology 

such as Computerized Physician Order Entry Systems (CPOE), bar-code technology, 

and drug administration systems, and through the development of standardized 

electronic medical records. However, there are very important issues surrounding 

their availability and implementation. Allow me to focus on CPOE and bar-coding 

as examples. 

One way patient safety can be improved by information technology is through the 

use of machine-readable symbols such as bar-codes in a standardized format on all 

quantities of medication matching the right drug to a patient bar-coded identification. Bar-code technology can enhance patient safety by ensuring there is real-time 

verification of the correct patient, medication, dose, and time. The AHA is very supportive of efforts underway at the Food and Drug Administration (FDA) to promulgate regulations that would require human drug products and biologics to be barcoded. 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 

16

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 overtaxed attempting to meet the obligations and deadlines set forth in the Health Insurance Portability and Accountability Act (HIPAA). 

CPOE is just one example of a promising technology where stakeholders need to 

work together before widespread implementation is a reality. But in many cases, 

successful implementation of new technologies will require further scientific advancement of the technology, worker buy-in, and capital to purchase needed technologies. Hospitals are committed to using the best available technology within their 

resources to improve patient care and reduce medical errors. Overcoming these obstacles will be critical to realizing the substantial benefits CPOE has to offer hospitals and the health delivery system as a whole. We look forward to working with 

the Congress, the vendor community, and others to address these issues so that we 

may truly improve patient safety and save lives. 

OTHER HOSPITAL CONSTRAINTS 

While I know that the focus of today’s hearing is on how to improve patient care 

and safety, it is important to understand this issue against the backdrop of the larger health care context. As this subcommittee is well aware, hospitals are facing unprecedented pressures that, when put together, threaten to erode the community 

hospital’s foundation. Let me just touch on a few. 

There is an alarming health care workforce shortage nationwide, with 168,000 

open positions in hospitals alone. Critical shortages in nursing and pharmacy positions hurt hospitals’ ability to successfully adopt new technologies, such as CPOE 

systems, which rely on the availability and expertise of pharmacy staff in particular. 

Hospitals are also facing soaring pharmaceutical prices, with annual double-digit 

increases in cost. Further, changes taking place in the legal system mean that hospitals and caregivers face considerable increases in professional liability coverage 

costs. And, as you know, we are working to provide new equipment and training 

17

so that our hospitals will be prepared for any emergency, including the threat of 

bioterrorism. 

In Connecticut last year, only a minority of hospitals had a positive operating 

margin. Throughout the United States, one-third of all hospitals are operating in 

the red and another third are teetering on the edge financially. It is vital that hospitals have adequate resources to meet the needs of their communities. This means 

not allowing ‘‘budget-neutral’’ spending decisions to further reduce Medicare and 

Medicaid payments to hospitals. And it means making improvements, such as the 

full Medicare inpatient inflation update, which will help us continue to meet the 

soaring demands being placed on us. 

Further, teaching hospitals, such as Danbury, are facing a significant cut in our 

graduate medical education funds. This scheduled cut must be eliminated if we are 

to continue providing sufficient resources to train the next generation of caregivers 

in the practices, and use of potential technologies, that can improve patient quality 

and safety for years to come. 

Finally, there are nearly 40 million people living in the United States who do not 

have health insurance at all. Medical studies demonstrate that the uninsured live 

sicker and die younger because they are forced to go without the medical help they 

need. The men and women of America’s hospitals see every day the devastation and 

pain that are caused when people do not have coverage, causing them to come to 

us much sicker than they should. 

CLOSING 

For thousands of years, healers have lived by the motto ‘‘primum non nocere’’—

first do no harm. The nurses, doctors, and others on the hospital patient care team 

strive every day to deliver safe, efficient, and compassionate care. But in today’s 

complex, high-tech world of medicine, despite our best efforts, we can have unwanted and unintended consequences. As good as our systems are for preventing 

and reducing medical errors of all kinds, we can and must do better. 

It is important that we continue to focus on what it means to promote a culture 

of safety. At AHA, and at Danbury Hospital, we are committed to these important 

issues. 

You have heard testimony about creating a culture of safety at the Veterans’ Administration (VA) and received a statement regarding the airline safety reporting 

system run by the National Aeronautic and Space Administration (NASA). There is 

much to learn from their successes in promoting a culture of safety, in particular 

through the creation of non-punitive systems for the reporting and sharing of adverse event information. 

In our efforts to create a culture of safety, there is a role for technology, and in 

particular CPOE systems, to help prevent medical errors and improve care. But we 

must be cognizant of technological, cultural, financial, and other challenges as we 

strive to provide the best possible health care to every patient that comes through 

our doors. Again, it is important to remember that there is not one solution or one 

activity that will make our systems error proof. 

We look forward to working with Congress, our colleagues, and the vendor community to address head-on the financial, technological, legal, and cultural issues 

that can help us cross what has been called a ‘‘quality chasm.’’

Chairman JOHNSON. Thank you very much, Dr. Miller. 

I would like to recognize Dr. Berwick, the President and Chief 

f Executive Officer (CEO) of the Institute for Health Care Improvements in Boston. Dr. Berwick. 

STATEMENT OF DONALD M. BERWICK, M.D., PRESIDENT AND 

CHIEF EXECUTIVE OFFICER, INSTITUTE FOR HEALTHCARE 

IMPROVEMENT, BOSTON, MASSACHUSETTS 

Dr. BERWICK. Thank you, Madam Chair. I have submitted my 

full remarks for the record. 

Since the IOM report, there has been indeed a lot of progress in 

this country, and I want to acknowledge that. The issue is explicit 

and visible. Most consumers seem aware that there are safety challenges in the health care system. A lot of hospitals have begun to 

18

promise to improve safety, and a small but important minority of 

them are becoming much more open about their own injury rates 

and measuring their frequency. 

Some of the highlights include the work at Pittsburgh you will 

be hearing about. I am aware of community efforts in Whatcom 

County, Washington and in Florence, South Carolina, to improve 

safety at the community level. There is a consortium of children’s 

hospitals that is focused on this as their primary agenda. I am 

aware of a collective of 57 hospitals working on substantial safety 

improvements, and other important progress is being made nationally. 

The Federal leadership on this has been dramatically important. 

The work at the VA, DOD, the Health Resources and Services Administration (HRSA), and most importantly, the Agency for 

Healthcare Research and Quality (AHRQ) has actually been, I 

think, the catalytic work in this country. I want to personally 

thank Congress on behalf of my colleagues for your commitment 

and bipartisan support for this work, but there are obstacles. We 

are not going fast enough. Let me tell you what some of the obstacles are. 

First, there is still denial in the industry. There are a lot of doctors and hospitals that still think this isn’t a problem. We need 

congressional voice, Federal leadership to say it is a problem and 

it must change. 

The second obstacle is capital costs. Some of the technologies to 

get safety systems into place are beyond the reach of small hospitals especially. There is a threshold to cross here. Last week the 

Advisory Board published a report saying that CPOE, which I thoroughly endorse, costs something like $7.5 million per facility. 

We know CPOE, for example, saves money. There is a good study 

in JAMA, the Journal of the American Medical Association, that 

said there is a 13-percent reduction in the total cost of hospitalization in hospitals with CPOE introduced, 13 percent on the bottom 

line of costs. I believe it is there, but it is downstream, and we 

have got to get over this activation issue. 

The third problem is, we are still paying for defects. I don’t think 

hospitals intend to hurt anyone, but it still is true that hospitals 

that injure patients get paid for treating those injuries. 

Fourth, there is lack of standardization. I will come back to that 

in a minute. The Federal government has a real opportunity to 

offer some standardization that would help the industry accelerate. 

Finally, there is persistent fear. For a lot of reasons—lawsuits, 

embarrassment, loss of market share—organizations, individuals in 

health care are very frightened to discover and reveal and discuss 

openly their defects. We have got to get over this. Fear is incompatible with learning, and safety can’t be achieved without learning. 

Safe systems are open, transparent systems. A frightened work 

force is not going to go there. 

We have been distracted by the issue of public reporting. I have 

an opinion on this. I think we need to be committed to transparency, but we have a very frightened work force that needs some 

security to know that they can discuss safety issues safely, or we 

are not going to get further on this. 

19

I think we have been stuck in a national debate about mandated 

reporting or not mandated reporting. I think we have to get over 

it. What we know is, safety has to be openly discussed, openly assessed, openly explored. The Centers for Medicare and Medicaid 

Services (CMS) should insist that health care organizations that it 

pays have to assess safety, they have to study it, they have to discuss it openly, they have to learn about their own injuries. That is 

for sure. 

I have six suggestions for Congress about things you could do 

that would help us at this stage. It is not primarily a Federal problem, but let me tell you what I think would help. 

First, please continue to support the investments that you are 

seeing in the VA, in HRSA, in DOD, and in AHRQ in this agenda. 

We are really getting some leadership out of these systems. 

I want to editorialize. I am deeply concerned about proposed 

budget cuts this year in AHRQ’s budget. If you proceed with the 

current budget, the Agency for Health Care Research and Quality 

will be unable to fund any new investigative research. It goes to 

zero, except in specific targeted areas. 

Now, you have made safety a targeted area, but that doesn’t 

solve the problem. Without investigator-initiated research, we are 

not going to get the learning we need in this field. If you do give 

AHRQ the funds it needs to support investigator-initiated research, 

it is a wise investment in how to manage a $1.5 trillion system, 

and I fear we are about to make a big mistake. 

Second, ask CMS to sponsor some market area experiments to 

reward quality and safety. Right now a hospital or health system 

that reduces injuries to patients actually takes a financial loss 

often because it gets paid for treating the consequences of its own 

injuries. We have to figure out how to stop paying for defects in 

care and start putting the opposite incentives to work: grants, tax 

credits, low-interest loans. There is some current legislation on 

this, but right now we are paying for defects and we have got to 

stop doing it. 

Third, I think we should, with all due respect to Mr. Stark, create a circumstance in which one, at least one State in this country 

can try a no-fault malpractice liability system. I think it will work. 

Here is the system we should try. It should have six properties: 

Always let patients and families know when a patient is injured, 

extreme honesty, and you are not in the system if you don’t adopt 

that. 

Second, apologize. We have trouble saying we are sorry. 

Third, compensate the victims of energy directly and fairly and 

promptly. Right now only 2 percent or 3 percent of the money that 

is being exchanged in the system is actually going to victims of injury. 

Fourth, bear the responsibility at the entity level. Let the hospitals, the health systems, bear that responsibility. Don’t go to the 

personal individual blame level, because that is going to increase 

the fear that is our problem in getting to safety cultures. 

Fifth, learn from the events, continually reduce risks within and 

among organizations. 

20

Sixth, deal differently with the criminal and grossly negligent. 

That has to be done promptly and severely, and that is 2 percent 

of the problem. 

I think a test of this kind of system in one State or one region 

of the country would teach us, and we win either way. If it works, 

we learn that it worked; and if it doesn’t work, we learn it doesn’t 

work and can move the agenda on. 

The fourth recommendation to Congress is, create some limited 

privilege for reporting on patient injuries for the individuals who 

make the reports. I think Jim has shown in the Michigan VA, we 

know from theory and practice in other industries, if there isn’t 

some form of protection for the individual—I do not think it should 

extend to the entity, to the hospital or the health system, but at 

the individual level there has to be protection, or people are no 

fools, they won’t talk about things when that talk is going to come 

back to hurt them. 

Fifth, don’t worry about constructing a large national database 

on errors or injuries. It will be a waste of time and money. We 

don’t need it. We should fund AHRQ thoroughly, to have a research 

database on this, and you are about to make a mistake if you proceed with the current budget on that, but if we fund the research 

work, that is all the data we need. We don’t need a massive national architecture on data on injuries. 

Finally, ask CMS to adopt some simple information technology 

standards. We really are stuck. It is one of the reasons Danbury 

Hospital has to spend so much money. I can explain this in questions if you want, but there are a few decisions we could make 

about standard vocabularies for coding in this country. 

If CMS said, ‘‘You must use these codes as a condition of participation,’’ we are done. It would be behind us, and then we can have 

a national data backbone that would allow hospitals and health 

systems to talk to each other, that would have saved Danbury millions of dollars, and Congress is in a really important position here. 

The CMS could actually make the difference in getting us there. 

We have made a great running start. I commend you for what 

has happened, and now we have a few more jobs to do and we can 

make it even better. 

[The prepared statement of Dr. Berwick follows:]

Statement of Donald M. Berwick, M.D., President and Chief Executive 

Officer, Institute for Healthcare Improvement, Boston, Massachusetts 

Since the IOM Report, To Err Is Human, released in November, 1999, the nation 

has made a great deal of progress in confronting the burden of injury from health 

care. We have made the issue explicit and visible. I think most consumers are now 

aware of the problem, which is a step toward building will for change. Some hospitals have promised to improve patient safety. A small, but significant, minority 

of hospitals have begun to look for injuries and to try to measure their frequency. 

Skillful experts, including some from other industries, have started to help us. 

Let me give you just a few highlights:

• A consortium of all stakeholders in the Pittsburgh area has publicly announced that they will reduce medication injuries and post-operative staph 

infections to zero. Similar consortia in Whatcom County, Washington, and 

in Florence, South Carolina, have made plans to improve medication safety 

dramatically. 

• The Children’s Hospital Corporation of America, involving several dozen 

children’s hospitals, has chosen patient safety as its major care improvement agenda. 

21

• Fifty-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. 

• A newly launched medical journal called ‘‘Quality and Safety in Health 

Care’’ is providing researchers and clinicians in the US and the UK with 

an outlet to publish their work. 

• The 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. 

• The VA and NASA have begun a fascinating collaboration on reporting systems and on human factors engineering.

The Federal government has been in the lead in this sea change. I think you already know that the Veterans Health Administration, the Department of Defense, 

the Health Services and Resources Administration, and, above all, the Agency for 

Health Care Research and Quality have invested heavily in new care initiatives, 

technologies, and research to make patients safer. The Quality Interagency Coordinating Task Force (QuIC), which has bridged two administrations, is a wonderful 

example of cooperative learning and action among agencies that too often in the 

past have not worked closely together on common issues. We would be nowhere near 

as far along as we are without this Federal leadership, and I commend both Congress and the Executive Branch for your commitment and bipartisan constancy on 

this issue. 

Along with this important progress, we have also now become aware of some obstacles. None of them are insurmountable, and in some cases, the Federal government can clearly help to accelerate change. Here are a few of the problems that 

have surfaced:

• First, 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. 

• Second, 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. 

• Third, 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. 

• Fourth, 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. 

• Fifth, 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 

22

emerging overall from the era of secrecy about performance of care systems, and the 

more recent IOM report, Crossing the Quality Chasm, called unequivocally for a 

whole new level of commitment to transparency, not just to inform consumers, but 

to allow health care systems, themselves, a better chance to learn from each other. 

Safety is important, and it is illogical to exempt it from the rule of transparency. 

On the other hand, we do know that people in health care are running scared, 

and that a frightened workforce hides its defects instead of learning from them. 

And so, we have gotten a little stuck since the IOM safety report. A few courageous health care organizations have just gone ahead and become open about measuring safety, and, I must say, they are none the worse for it. Most, however, are 

still pretty timid about it. They fight disclosure, and they fight CMS when they propose that safety should be openly measured and discussed. 

In my opinion, it is high time to leap over our shadow on this one. I simply do 

not believe that a risky, complex, stressed industry will have the will or the knowledge it needs to move beyond traditional assumptions about achievable performance 

unless and until it faces facts and data on its own work. Safety should be a topic 

openly discussed, openly assessed, and openly explored, and I hope that CMS, like 

other important purchasers, will do what it can to assure that that open dialogue 

becomes more and more widespread. CMS should insist that the health care organizations it pays must assess, study, and learn about their own patient injuries, disclose those injuries to the patients who are harmed, and continually and demonstrably reduce the risks of injury. 

Congress can help this maturation to occur by a few, simple, persistent steps:

1. Continue to support the investments of the VA, HRSA, DoD, and, 

most crucially, AHRQ, in the agenda of learning and improvement of 

patient safety, for the benefit of their patients, and for the instruction of all.

I am deeply concerned about this year’s proposed reductions in the budget of 

AHRQ. It would be wise to expand, not to cut, our nation’s meager investment 

in studying how our $1.5 trillion care system can be made better continually. 

Preserving line items for patient safety research is helpful, but not at all sufficient. Please understand that the proposed AHRQ budget would bring nearly 

to a standstill new investigator-initiated health services research proposals—

bring them to zero—and that means a sudden slowing down of research and investment which ultimately has a major impact on the well-being of our patients. 

If you give AHRQ the funds it needs to support investigator-initiated research, 

even more than in the past, you can count on a high rate of return in health 

care quality improvement.

2. Ask CMS to sponsor and allow several market-area experiments to 

reward quality and safety. Try to adjust payment streams so that health 

care organizations that become safer thereby become more viable. Right now, 

a hospital or health system that reduces injuries to patients often actually loses 

financially, because it gets paid for defects. We have to figure out how to stop 

paying for defects in care, and to start putting exactly the opposite incentive 

to work. Pay hospitals more when they reduce their injury rates, and less when 

they don’t. Grants, tax credits, or low-interest loans, as some currently proposed 

legislation would offer, may help some of the less wealthy hospitals move faster 

into modern information systems.

3. Create the circumstance in which at least one state or area can test 

a no-fault malpractice liability system for a few years, so that we can 

begin to put to rest the most commonly cited obstacle to openness. Either we 

will learn that that leads to much more openness, or that it doesn’t, and, either 

way, we gain knowledge we badly need. The system we most badly need to test 

would have the following components: (a) always letting patients and families 

know when a patient is injured by care (‘‘extreme honesty’’); (b) apologizing; (c) 

compensating victims of injury fairly and promptly; (d) bearing this liability at 

the ‘‘entity’’ level (hospital, health care system), not at the personal level (physician, nurse); (e) learning from events, and continually reducing risks within and 

among organizations; (f) dealing differently and promptly with the small class 

of criminal and grossly negligent events.

4. Create some limited privilege for reporting on patient injuries for 

the individuals who make those reports. I am not asking for secrecy at the 

entity level, but rather for some protection for a doctor or nurse who sees something go wrong, or actually falls into some pattern of error, and who can and 

will talk about it, but only if that does not come back to hurt them.

5. Do not worry about constructing some massive national database on 

errors or patient injuries. We don’t need it. It may help if AHRQ has a reVerDate Sep 04 2002 01:19 Oct 03, 2002 Jkt 081751 PO 00000 Frm 00026 Fmt 6633 Sfmt 6621 E:\HR\OC\B751.XXX B751
23

search database of that type, but regional and statewide reporting systems will 

be quite enough if we also have ways for the people involved in those systems 

to meet and talk with each other and to share what they are learning.

6. Ask CMS to adopt some information technology standards, required of 

those organizations they pay, for coding of messaging, medications, laboratory 

tests, and diagnoses. It is important, and feasible, for CMS to select a single 

set of such standards from among several good available options, and then to 

build confidence in the health care system that these will remain stable for a 

considerable time, so that it becomes prudent and logical to invest in compatible 

data systems with confidence that they will work well into the future. That will 

make CPOE and other safety-enhancing computer technologies much more attractive and feasible. I also think CMS should join the Leapfrog Group in informing hospitals that, by some deadline, a hospital without either CPOE or a 

demonstrably better method for medication safety cannot be a Medicaid provider.

We really have a running start now on making health care safer. We need to 

keep the heat on the topic, invest in the research to know how to improve the 

situation, insist on openness and sharing, pay more for quality than for defects, 

and make it both important and safe for the wonderful people who work in 

health care to learn about their own errors, about the harm done to patients, 

Chairman JOHNSON. Thank you very much. 

Ms. Foley, President of the American Nurses Association. 

and about how to reduce that harm continually.

f STATEMENT OF MARY FOLEY, PRESIDENT, AMERICAN NURSES 

ASSOCIATION 

Ms. FOLEY. Thank you, and good morning. I really do appreciate 

the opportunity to be here and return to the table to talk about the 

importance of prevention of health care injuries. 

As you know, there are more than 2.7 million registered nurses 

in the country right now, 2.2 million of us are still working in the 

field. We are very committed, and it has always been a cornerstone 

of our nursing profession to be worried about and try to attend to 

the issues of patient safety. 

Of course, as you have mentioned, Congresswomen, the landmark report ‘‘To Err is Human’’ really brought this attention to the 

forefront. It was the most talked-about health care issue in the 

year 2000, and while I do also agree with our previous speakers, 

there has been some good work started, we need to continue to 

push on the issue of systems of care and systems of safety that protect our critically important patients. 

I am here, however, to put a slightly different face on the discussion because the system of safety cannot overlook the people who 

provide the safety net and the monitors of safety, and for us nurses 

play that role in a very critically important manner. 

We have long maintained, and we are beginning to get some significant research which validates the relationship between high 

quality, safe patient care and the amount and the skill of the nursing staff, and we applaud the research that has been supportive of 

those findings. The CMS and four U.S. Department of Health and 

Human Service agencies in the years 2000 and 2001 have reported 

correlations between safe staff and certainly the reduction of complications and injuries such as falls. 

I support, as does nursing, the implementation of technology, for 

example, computer order entry, but the pursuit of technology 

should not be in a vacuum. it must consider the people who will 

24

then be part of that system. I think Dr. Miller mentioned the training, but importantly as well the people who provide the care and 

do the actual monitoring and assessment are just as critical to a 

good computer order entry system, so the pharmacists and the 

nurses have to be present in adequate numbers and with qualifications that are commensurate. 

We also know, as I have mentioned, that—well, so on the issue 

of staffing, I just want to reiterate that we are recommending then 

efforts to support valid and reliable staffing measurements that 

really address what are the needs or the acuity of our patients, and 

that that concept be integrated into Medicare and Medicaid programs as a form of condition of participation. 

We very strongly applaud the efforts of the Veterans Administration. They are demonstrating the best practices, particularly in the 

area of early reporting and near miss analysis, and I think that is 

a field that needs to be further promoted and supported. 

Additionally, we are very concerned about skilled nursing facilities. I have been very alarmed by the reports that we have heard. 

Nurses are not surprised, however, by some of the shocking findings that we are hearing about care in skilled nursing facilities. We 

continue to support adjustable minimum nurse-patient ratios in 

those settings. 

Let’s talk about the issue of mandatory overtime. Again, the system of care and the human factors involved in the safe delivery of 

care, there is inadequate research. It is beginning to be performed. 

We have one particular study, an AHRQ-funded study, to look at 

nurses and fatigue. 

Over two-thirds of nurses in a survey last September told us that 

they are being asked to work unplanned overtime, and of course 

the epidemic of mandatory overtime has been both a very negative 

image for nurses, it is affecting our ability to recruit and retain, 

and we know we have a shortage coming. More importantly, we are 

very concerned about the safety of nurses who feel that they are 

too fatigued to provide safe care, and there are ample studies that 

show that fatigue has a correlation to injury and safety issues. So 

we do support Congress’s continued discussion and support for the 

Safe Nursing and Patient Care Act of 2001, which we think is a 

balanced approach. 

Let me just quickly mention the reporting, the role of the whistle-blowing. Mr. Stark, thank you for mentioning that, very much. 

The ability to safely report, in fact the enhancement of safe reporting mechanisms is very important to nursing. If we cannot speak 

out and let people know when we see care that is inadequate or 

unsafe or lax quality and there are negative repercussions, it will 

be difficult to be the full advocate that we believe we must be and 

that we should be. 

So, in conclusion, I would like to just continue to support this 

system approach, but the people as part of that system must be 

considered. They have to be able to be there. All nurses want to 

do, and I have said this many times, all nurses want to do is give 

good care. We must attend to the people and the equipment and 

to the technology that makes that care possible. 

I would have to say, very importantly, though, Congressman, you 

asked us about the cost. The alternative to a safe system with adeVerDate Sep 04 2002 01:19 Oct 03, 2002 Jkt 081751 PO 00000 Frm 00028 Fmt 6633 Sfmt 6602 E:\HR\OC\B751.XXX B751
25

quate staff is the cost of untold numbers of injuries, errors, terrible 

patient satisfaction, and the cost of that type of system is unacceptable. I am a believer in prevention. I believe the investment in a 

safe environment with adequate staff who are well qualified and 

well cared for will indeed pay dividends over the many years to 

come. 

Thank you. 

[The prepared statement of Ms. Foley follows:]

Statement of Mary Foley, President, American Nurses Association 

Good morning Madam Chair and Members of the Subcommittee, I am Mary 

Foley, MS, RN, president of the American Nurses Association. Thank you for the 

opportunity to discuss our concerns regarding patient safety and medical errors. 

ANA is the only full-service association representing the nation’s registered nurses 

(RNs) through its 54 constituent nurse member associations. Our members include 

RNs working and teaching in every health care sector across the entire United 

States. I myself have more than 25 years experience as a staff nurse, a nurse executive and a clinical instructor in nursing. 

Numbering more than 2.7 million, nurses are the largest health care workforce 

in the nation. From the nurse midwives who attend delivery, to geriatric nurse practitioners who manage end-of-life care, to staff nurses who care for us during times 

of acute injury or illness, nurses are integral to health care across the human lifespan. We touch patients and manage teams of medical professionals in hospitals, 

clinics, community health centers, offices, nursing homes and patient’s homes. We 

are the ones who will ultimately implement and be impacted by new patient safety 

initiatives. Therefore, nurses have a substantial contribution to make to the developing debate on medical errors. 

The issue of patient safety has always been the cornerstone of nursing. The Code 

of Ethics for Nurses clearly states that ‘‘as an advocate for the patient, the nurse 

must be alert to and take appropriate action regarding any instances of incompetent, unethical, illegal, or impaired practice by any member of the health care 

team or the health care system or any action on the part of others that places the 

rights or best interests of the patient in jeopardy.’’ ANA has been active in the debate on medical errors, both prior to the release of the Institute of Medicine (IOM) 

study To Err is Human and since it publication. This statement provides a summary of our actions and positions, and our requests for future policy. 

The Changing Health Care Delivery System 

The landmark IOM report To Err is Human (1999) described a fractured health 

care system that is prone to errors and detrimental to safe patient care. This problem is readily apparent to the nurses who have been caught inside the topsy-turvy 

world of our rapidly changing health care delivery system. We have seen market 

forces, reimbursement changes, and new technologies revolutionalize health care. 

Unfortunately, these changes have not always resulted in better patient care. 

In the past decade, the advent of managed care and changes in Medicare reimbursement have exerted downward pressure on provider margins. As a result, 

health care facilities have employed radical cost reduction programs. Throughout 

the 1990s, new models of health care delivery were implemented, and highlytrained, 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. 

26

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 

27

patient safety, and we look forward to working with the Veteran’s Health Administration officials as they develop a new national nurse staffing policy. In addition, 

we support efforts to enact upwardly adjustable, minimum nurse-to-patient staff ratios in skilled nursing facilities. 

The Critical Problem of Mandatory Overtime

By far the riskiest result of understaffing is the abuse of mandatory overtime as 

a staffing tool. Nurses across the nation have told me their concerns about the dramatic increase in the use of mandatory overtime. ANA hears that employers are insisting that a nurse work an extra shift (or more) or face dismissal for insubordination, as well as being reported to the state board of nursing for patient abandonment. 

The use of mandatory overtime is not as uncommon or isolated as some would 

have you believe. In fact, the term ‘mandation’ has been coined by the health care 

industry to describe this staffing tool. A recent ANA survey (sample size 4,826) revealed that two-thirds of nurses are being required to work some mandatory or unplanned overtime every month. 

ANA’s concerns about the use of mandatory overtime are directly related to patient safety. We know that sleep loss influences several aspects of performance, 

leading to slowed reaction time, failure to respond when appropriate, false responses, slowed thinking, and diminished memory. In fact, 1997 research by Dawson and Reid at the University of Australia showed that work performance is more 

likely to be impaired by moderate fatigue than by alcohol consumption. Their research shows that significant safety risks are posed by workers who stay awake for 

long periods. Thus, it only stands to reason that an exhausted nurse is more likely 

to commit a medical error than a nurse who is not forced to work overtime. 

Nurses are placed in a unique situation when confronted by demands for overtime. Ethical nursing practice prohibits nurses from engaging in behavior that they 

know could harm patients. At the same time, RNs face the loss of their license—

their careers and their livelihoods—when charged with patient abandonment. Absent legislation, nurses will continue to confront this dilemma. For this reason, ANA 

supports the Safe Nursing and Patient Care Act of 2001 (H.R. 3238, S. 1686) which 

would ban the use of mandatory overtime through Medicare provider agreements. 

ANA supports working through the Medicare system because we believe that the 

abusive use of overtime promotes poor patient care and therefore is a matter of public health safety. Just as limits on work hours for airline pilots, flight attendants, 

and truck drivers are enacted through transportation law, we believe that this matter should be handled through health law. The Safe Nursing and Patient Care Act 

is a fair, measured response to the abuse of mandatory overtime. ANA strongly encourages all Members of this Committee to support its enactment. 

Patient Advocacy and Whistleblower Protections 

In addition, ANA maintains that nurses must be able to speak out about qualityof-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. 

28

Where to Start?

A number of experts, including those sitting here with me today, have proposed 

valuable solutions to the problem of medical errors and patient safety. ANA supports many of these initiatives; however we insist that the central issues of staffing, 

overtime and whistleblower protections must not be lost in this debate. 

Medication errors serve as a good example. The IOM estimates that medication 

errors increase hospital costs by about $2 billion per year. Disturbingly, the IOM 

also estimates that the number of lives lost to preventable medication errors alone 

represents over 7,000 deaths annually—more than the number of Americans injured 

in the workplace each year. The U.S. Pharmacopeia, which has tracked medication 

errors since 1991, recently reported on the first full year of an internet-based reporting mechanism for medication errors and near misses. The analysis of 6,224 reports 

revealed that most errors occur in the administration of medications—the delivery 

to the patient. U.S. Pharmacopeia reports that, ‘‘the primary contributing factor to 

medication errors were distractions and workload increases, many of which may be 

a result of today’s environment of cost containment.’’ ANA could not agree more. 

While we support innovations such as information technology designed to reduce 

medication errors, we understand that these efforts will not be successful if the 

broader system issues are not addressed as well. In the end, any system that requires a nurse to work a 16-hour shift, while caring for too many critically ill patients, in a ward where he or she is not supported by adequate staff is destined to 

failure. 

Conclusion 

Madam Chair, I have been a registered nurse for more than 25 years. I have been 

a staff nurse, a nurse executive, and a clinical instructor in nursing. I know something about nurses. We are called to the profession by a desire to provide compassionate care to people in need. Believe me, no one becomes a nurse for the money. 

We are driven by a desire to provide safe, high-quality health services. We will remain in patient care as long as this is possible.As long as unreasonable schedules, 

dangerous understaffing, and fears of institutional reprisal keep nurses from meeting this calling, many will continue to leave the bedside. Nurses do not want to be 

a part of a health system that fails to meet the needs of patients. Registered nurses, 

hospital administrators, other health care providers, health system planners, and 

consumers must come together in a meaningful way to create a system that supports both patients and health care providers. We should begin by improving the 

environment for nursing.

Chairman JOHNSON. Thank you very much. 

Dr. Feinstein, Chair of the Pittsburgh Regional Health Initiative 

f from Pittsburgh. Welcome. 

STATEMENT OF KAREN WOLK FEINSTEIN, PH.D., PRESIDENT, 

JEWISH HEALTHCARE FOUNDATION OF PITTSBURGH, PENNSYLVANIA, AND CHAIR, PITTSBURGH REGIONAL HEALTHCARE INITIATIVE, PITTSBURGH, PENNSYLVANIA 

Dr. FEINSTEIN. Thank you, Madam Chair. I also want to express the regrets of Secretary O’Neill, who is in Kuwait, who would 

be here to testify. His testimony is on the table. Secretary O’Neill 

and I, before he was Secretary, Co-chaired the initiative that you 

referred to, the Pittsburgh Regional Healthcare Initiative, which 

we view as a vast learning network involving the total collaboration of all the hospitals in our region to reduce medical error, hospital-acquired infection, and most importantly, Madam Chairman, 

to follow through on what you suggested, which is the critical systems redesign on all levels, so that people within health care can 

do things right. 

That is so critical to us because getting to the root cause of patient safety issues really isn’t another layered-on activity with all 

the other things we layer on at the hospital level, but it is part of 

29

a total systems redesign, a new way of regarding the health care 

enterprise that is so critical to overall process improvement. 

At the moment, we are the first region in the country where competing hospitals have come together in total collaboration, to count 

every medication error and infection, count them the same way, 

and share that information openly. Thirty hospitals, twenty corporations, four health plans, a small business purchasing coalition, 

hundreds of health professionals have all come together, many of 

whom have signed contracts pledging themselves to work toward 

zero perfection goal in medication errors and in hospital-acquired 

infections. 

As I wanted to mention, even though we have come together, we 

have all installed the same databases and we are using and sharing information, I do want to assure you, because this issue has 

been raised, our hospitals are no less rancorous and competitive 

than any others. As I like to say, our health system is just as sick 

as any other community’s. It is not because everybody gets along 

in Pittsburgh that we are able to collaborate. 

The reason we have been able to come together is a collective 

awareness of the scale of the problem, of the errors that plague our 

hospitals and the overall system errors, not just medication and infection, that result in waste, overuse, inefficiency, and often a lack 

of applying the best practices even though there is good knowledge 

to suggest what we should be doing. 

The core in our mind of what was wrong is that our systems 

have lost a collective focus on helping care teams deliver the right 

care every time for every patient, which leads to the inevitable imprecision, waste, and errors about which we have convened today. 

When we realized that the systems issues were the root of the 

problem, we wanted to look at a powerful model for process improvement, and we turned to Alcoa. We couldn’t find anything as 

powerful. 

We wanted to look at some organization, that had adopted a successful framework for quality and safety, so we went to Alcoa. 

Alcoa is headquartered in Pittsburgh, and it had the best safety 

record in the world. Think of this, it is 18 times safer to work in 

Alcoa with molten metal and sheaves of aluminum, all four edges 

are like knives, than it is to work in your average hospital. 

So we were looking for something powerful in the way of process 

improvement that would move us to the kind of systems change 

that we had seen at Alcoa, engaging every professional at the point 

of care in becoming an improvement scientist, helping everyone 

look at each problem, each error, as an opportunity for learning, for 

the root cause analysis, experimentation, measurement, and shared 

learning you have heard here. 

I would like to echo Don Berwick’s comments. We really couldn’t 

be doing what we are doing now in our collaboration, with our 

databases installed to capture our hospital acquired infection data 

and the shared learning that is going on, without the Centers for 

Disease Control Prevention (CDC)and their NNIS, the National 

Nosocomial Infectious Surveillance, system for measuring infection. 

Obviously, good data entry, analysis, attempting solution and 

then sharing the learning, are essential. Believe me, the databases 

30

alone, without the support in how to use them and how to gather 

learnings, wouldn’t get us to where we are. 

Let me quickly say, the kind of support that we would love to 

have, that we would need from the Federal government to get to 

this system of perfect patient care to which we aspire, is increased 

confidentiality protections. We can’t deal with errors, we can’t solve 

them to root cause, without confidentiality protection. 

Second, we need support for an environment where these clinical 

data systems and other methods we are using to get better patient 

outcomes, where constraints are removed, rewards are introduced. 

Expanding a Federal partnership, working with CMS, AHRQ, 

CDC, and others to continue doing this is incredibly important to 

us. 

One of our most powerful learning tools as well as our databases 

is observation. We want to engage the appropriate Federal agencies 

in direct learning and more collective observation at the point of 

care, to see where rules and regulations and other constraints impede our efforts to bring about the systems change. 

We suggest Federal support for more demonstrations applying 

successful industrial models, such as the Toyota Production System 

model we are using, in local hospitals. We would also like to see 

training in safety, both worker and patient safety and systems improvement, a core component of the education of all health professionals. 

We would also like to see more medical research and education 

funding dedicated to improving quality of care delivery at the point 

of care. We need new knowledge about how to deliver health care, 

and how to apply the knowledge we already have more perfectly. 

Along with that, of course, I would like to suggest we would benefit 

from experiments in methods of payment that provide incentives 

for doing the right thing at the right time. We have tried very hard 

to enlist the professionals at the point of care as the driving force 

in our initiative. I want to emphasize how important I think that 

has been to us, and the fact that they are allowed to experiment 

and come up with their own solutions is a critically important 

learning tool. 

Thank you very much. 

[The prepared statement of Dr. Feinstein follows:]

Statement of Karen Wolk Feinstein, Ph.D., President, Jewish Healthcare 

Foundation of Pittsburgh, Pennsylvania, and Chair, Pittsburgh Regional 

Healthcare Initiative, Pittsburgh, Pennsylvania 

Chairman Johnson, Congressman Stark and distinguished Members of the Committee: 

I am Karen Wolk Feinstein, Chair of the Pittsburgh Regional Healthcare Initiative (PRHI)—a community-wide effort to establish Southwest Pennsylvania as the 

world leader in patient outcomes—including perfect patient safety. 

On behalf of the more than 30 hospitals, 20 corporations, four health plans, small 

business purchasing coalitions, unions, government officials, and hundreds of physicians, nurses pharmacists and other clinicians that constitute PRHI, it is an honor 

to be asked to testify today. 

Two days ago, in downtown Pittsburgh, CEOs from the region’s competing hospitals met to openly review patient safety incidents in their institutions and to discuss powerful leadership approaches to address those errors. Today, I’d like to tell 

you why this is happening in our community, describe help we have already received from federal partners, and note how federal policy can help efforts like ours, 

if the intention is to fix healthcare systems ‘‘from the bottom up.’’

31

For us, addressing safety issues is not adding another layer of activities for hospitals and other healthcare providers. Achieving safe practices is integrally connected to the entire process of restoring each patient to health as quickly as possible. 

To err may be human, but failure to share those errors, learn from them, and prevent them from happening again is unforgivable. Cloaked in darkness, secrecy and 

fear of reprisal, medical mistakes are not used for learning, so they are repeated. 

Like Sisyphus, we err and err again because we do not fix our systems after each 

error to prevent future ones. 

That is why, in American health care today, a hospital patient has a 7% chance 

of contracting a preventable hospital-acquired infection during their care, and a 

2.3%–4.6% chance of being damaged by a medication error. 

The scale of damage is stunning. Recent anthrax attacks took five innocent lives. 

Healthcare-acquired infections are associated with 88,000 deaths each and every 

year, and afflict more than two million Americans a year. The direct financial cost 

of caring for these infections in our region alone exceeds $110 million per year. In 

fact, our first data sharing efforts show that just one type of infection (blood stream 

infections) in intensive care units costs our region $15 million a year. As this Subcommittee knows, the story isn’t any better for medication errors. They wound or 

kill approximately 770,000 Americans annually. But these aren’t the only costs associated with errors. 

The reason errors occur at shocking rates is also the reason why the American 

healthcare system is staggering on so many fronts, including escalating costs and 

rising dissatisfaction among all healthcare workers. What is that reason? We have 

lost our collective focus on helping care teams deliver the right care, every time, for 

every patient. Imprecision, waste, and errors are inevitable. 

To regain our focus on the patient and to learn how to create a better performing 

healthcare system in our region, more than 30 hospitals and PRHI’s other coalition 

members have formally committed to working together to eliminate medication errors and healthcare-acquired infections. (PRHI hospitals are also working to perfect 

patient care in six areas of clinical medicine). 

In setting this framework for change, we drew our inspiration from Alcoa, which 

is based in Pittsburgh, and PRHI’s founding Chair, now-Treasury Secretary Paul 

O’Neill. In 1987, when Secretary O’Neill became its CEO, Alcoa publicly committed 

to eliminating workplace injuries. Over the next 13 years, all of its employees 

worked together to learn how to do so, from the maintenance worker in Brazil to 

the CEO in Pittsburgh. Alcoa is now the safest workplace in the world. In 2002, 

Alcoa—a heavy manufacturing company with 140,000 employees in 37 countries—

is 18 times safer to work in than the average hospital. 

It is no coincidence that over the same period, Alcoa experienced dramatic overall 

gains in its business, becoming by far the world’s largest, most efficient and most 

profitable aluminum producer. 

To move decisively toward those kinds of results in our community’s healthcare 

delivery system, we have become the first region in the country where competing 

hospitals have begun efforts to count every medication error and infection, count 

them in the same way, and share that information openly for the purposes of learning. 

We have had extraordinary help from federal agencies and national resources. 

The Centers for Disease Control in Atlanta has been a generous strategic partner 

in attacking healthcare-acquired infections. Recognized as a world authority in infection control and public health, the CDC has been collecting hospital-acquired infection rates through the National Nosocomial Infection Surveillance System (NNIS) 

for 30 years. NNIS has, however, historically been available only to hospitals that 

meeting rigid criteria, due to funding and other constraints. CDC generously made 

a variant of its NNIS system available to each PRHI hospital. CDC also provides 

extensive on-site instruction and support for our efforts. Our first shared target for 

surveillance and improvement, initiated April 1, 2001 has been a catastrophic type 

of blood stream infection occurring in intensive care units. We are moving on to 

other critical infection types this year. 

To report and learn from medication errors, PRHI’s partner hospitals have all 

agreed to use U.S. Pharmacopoeia’s MedMARx system, a web-based error reporting 

tool that allows healthcare workers to describe errors and their contributing causes 

according to the most credible national standards, and to learn from the experiences 

of other hospitals in the system. PRHI hospitals share their information regionally 

as well as nationally. Pittsburgh area hospitals constitute less than 5% of the hospitals contributing error reports to MedMARx, but have provided approximately 

15% of the errors reported to MedMARx to date. This does not mean that Pittsburgh 

32

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:

• Increasing 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. 

• Increasing 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. 

• Expanding 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:

• Invest in demonstrations applying successful industrial models, such as the 

Toyota Production System, to health care. (We have such experiments underway at five local hospitals). 

33

• Make training in safety and systems improvement a core component of medical education. 

• Increase medical research funding dedicated to encouraging academic physicians and institutions to become more deeply involved in measuring and improving quality of care. 

• Accelerate 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.

thoughtful remarks. 

Chairman JOHNSON. Thank you. I thank the panel for their 

f 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 

34

you must demonstrate it, and leadership, and I can’t emphasize 

this enough. 

One of the things we did is at every facility, the facility chief executive officer has to actually concur or not concur with each line 

item of a recommendation that a team—this is a team of nurses, 

physicians, pharmacists—says this is what needs to be done. If 

they nonconcur, they have to put in writing, in the record, why 

they don’t concur, and then it goes back for revision, but they can’t 

just say, ‘‘I don’t like to do this.’’

That has caused tremendous better communication within the 

hospital in general, and actions taken, because where the accountability, if there is any, resides, if you want to look at it that way, 

is with the chief executive officer of the hospital, that they take responsibility that these improvements will be made. I think when 

people—and we have gotten reports from the field that people can’t 

believe that problems that were dealt with in a punitive manner 

before actually are dealt with in a constructive manner, that they 

actually see improvement, and that kind of primes the pump and 

it builds on itself. 

Chairman JOHNSON. Thank you. Anyone else wish to comment? 

Mary? Ms. Foley? 

Ms. FOLEY. Yes, thank you. I think it is an excellent question. 

I think it is consistent with the environment of both the blame-free 

and the non-disciplinary approach. I mean, the ultimate, not the 

ultimate sacrifice but a severe sacrifice for someone who believes 

it is imperative for them to professionally report an incident or a 

practitioner is the loss of a job, and that indeed is what we are attempting to prevent by passing the whistle-blower protection. 

So, it is an extreme type of discipline or intervention that really 

just puts a, casts a pall over people’s belief that it is the right 

thing, it is the necessary thing to do. It is not the only approach. 

I think there are many levels of just that stimulating the reporting 

in an environment in which it is safe, that it is protected, that it 

is promoted. The whistle-blower is an extension of that same type 

of protection for that more severe action, and we see it connected 

because that whole attitude, that there are costs to doing the right 

thing, has to be eliminated or people will be repressed, and that 

is unfortunate. 

Chairman JOHNSON. Dr. Miller? 

Dr. MILLER. I certainly agree with what has been said already. 

I would just add that within an organization, often you want to 

promote the culture of reporting but you also want to make that 

easy to do, and it is not always so easy. It takes time to report. 

The reporting can be confidential or not confidential. 

In terms of whistle-blower kinds of things, we certainly have 

those things in place in our organization, but we actually tie it to 

a little bit of what Dr. Bagian was talking about. If someone wants 

to report an error, they can do it confidentially, they can do it by 

phone, they can do it in writing, but we have a policy that within 

5 days we get back to them. 

Whoever, if they say who they were, we not only protect them 

for reporting it and encourage it—and my report card internally is 

to have more errors reported this year, not fewer—but that we 

have an obligation to get back to whoever blew that whistle, if you 

35

will, and tell them what our action was. Sometimes there is no action that can be taken, but they deserve a response, and I think 

that takes care a lot of the disgruntled employee, or nurse or pharmacist or doctor that says, you know, ‘‘I can’t bother complaining 

anymore. Either they will go after me or they won’t do anything 

about it anyway.’’

Dr. FEINSTEIN. Madam Chairman? 

Chairman JOHNSON. Dr. Feinstein? 

Dr. FEINSTEIN. Can I say one thing, too? I would de-emphasize 

issues of whistle-blower protection and focus on developing a positive reward system, with incentives that a chief executive officer 

who is really committed to solving problems and having an errorfree 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. 

36

You might all think about, how can we hold the top executive 

more accountable for that leadership, as opposed to providing whistle-blower protection? Because in the end culture change can’t be 

done negatively, it has to be done positively. 

Now, I separate this entirely in my mind, although I know 

they’re not entirely separate, from this issue of mandatory overtime 

which I think is a very serious development in our system, and will 

carry with it enormous potential for errors if we don’t do something 

about it. So, you know, I want to recognize that, because I have 

had some terrible examples come to my attention of the abuse of 

mandatory overtime. I think nonetheless cultural change cannot be 

legislated from Washington, so the question is, how do we change 

the way we hold our systems accountable and look at you? 

Then I want to just get back to this issue of cost. You have given 

us some very good information about the initial cost. It is clearly 

multi-million. Why is it that our capital payment system isn’t sufficient, or is it? 

We no longer make you prove that you made capital expenditures in order for us to give you capital payments. There is sort of 

an automatic capital payment system now that gives you money, 

assuming all of the kind of technology change and the various 

things you have to do to upgrade your operating rooms and so on. 

So, why isn’t that sufficient to focus on this issue, or is it? Dr. Miller? 

Dr. MILLER. Unfortunately, it is not. I can give you an example 

from Danbury. We do run in the black, and we have dollars that 

are available for capital purchases every year, and the price tag on 

those purchases, capital purchases or renovations, goes up annually. Pharmacy costs are going up double-digit annually. New technologies that we need to have in order to provide quality care to 

our patients, I don’t mean something esoteric or to compete, I mean 

quality care for patients, those things cost more money. 

Very specifically, we talked about the dollars for computerized 

physician order entry. A single example, one 371-bed hospital. This 

fiscal year, our clinical leaders for capital equipment purchase requests was $50 million. I had $20 million to spend. That means 

$30 million that was requested, not for frivolous things but for replacement items, renovations, fix this, the physical plants that 

weren’t as sturdy as they once were, they were built 25 years ago, 

new technologies that a new surgeon wants in the operating room, 

all those things cost money. I don’t have enough money for this 

year’s requests. New technologies like physician order entry, and I 

had to get the budget to approve that, meant there were $2 million 

worth of things that I couldn’t buy instead. 

Chairman JOHNSON. Thank you very much. Dr. Berwick? 

Dr. BERWICK. Thank you, Madam Chair. I want to divide the 

capital question into several categories because it is not one problem. 

First problem, wiring physician offices. Five years from now 

there is no reason in this country we should have handwritten prescriptions. There is no reason any physician shouldn’t have access 

to a hospital medical record for one of his patients. There is no reason we shouldn’t have a master drug list. 

37

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. 

38

There is the DICOM, the Digital Imaging and Communications 

in Medicine system. 

We don’t know quite yet nationally how to code drugs, medications, and we really need to. We need to have a standard medications coding system in the country. 

We don’t know how to code procedures yet, although there are 

several options. Within 6 months, if you told CMS, ‘‘Let’s establish, 

let’s have the backbone, let’s say these are the systems, they’re not 

going to change,’’ you will save millions of capital for hospitals like 

Danbury, and we will get on with the job. I think it will require 

Federal leadership. We don’t have another structure to get that job 

done. 

Chairman JOHNSON. Thank you very much. I am going to turn 

to Mr. Stark, and yield the Chair to Mr. Camp of Michigan. Thank 

you. 

Mr. STARK. Thank you, Madam Chair. 

Let me just take one more crack here at EMTALA, the Emergency Medical Treatment and Active Labor Act, and the Patients’ 

Bill of Rights bill, which has been passed in both Houses, and a 

section which I think has no quarrel from either side of the aisle 

or in either House. Is there anybody who would object to either of 

those standards being used? 

Now, the American Hospital Association has, but tell them to get 

with it, Dr. Miller. I mean, I think we can find and take care of 

that, and I think everybody understands that it is the issue of the 

subordinate who reports to their supervisor, who ignores them, and 

then the subordinate goes elsewhere. Arguably that is not desirable, but it probably is more desirable than having a subordinate 

who will suborn those issues. I think we could get that one taken 

care of pretty quickly. 

The issue of capital and getting the system working just may 

very well be a problem in the system. When you allow or encourage, depending on what State you are in, a lot of competition and 

oversupply, when you are running less than 60 percent of staff-bed 

occupancy, then you have got to say, ‘‘Well, wait a minute.’’ Or 

when you have got to make the case that you want to buy a computer system for a 20-bed rural hospital. It would probably cost almost as much as it would for your hospital, Dr. Miller, but you 

have got 20 times more people that you are serving. 

That politically, you know, you can’t get any of my colleagues 

who want to close the hospital, as small as it may be, on their 

watch. Nobody builds statues to us in our home district for closing 

a hospital or a post office. So we have got to find some way for the 

communities to get off stage, to perhaps consolidate, to share 

equipment. I don’t know, we aren’t going to be able to do that, and 

that is part, I think has got to be part of this. 

In the costing, one of the things that occurs to me is that you 

all in the hospital business don’t take your recalls. I take my car 

in to get it tuned up and they do something, the dealer has to fix 

it for free if they screwed up, right? I go to the hospital and something happens subsequently, poor Blue Cross has got to pay again 

to send me back. 

Now, if we changed the system and you had to do your own recalls, that is either a loss of revenue or an increase of cost, you 

39

slice it either way you want, and I suppose you ought to be compensated for that. I mean, I think if that is part of what is having 

people drag their heels on this, and I don’t know whether they are 

so harsh that they are willing to say, ‘‘We won’t do it because it’s 

going to cost us more to correct our mistakes,’’ I hope that people 

aren’t thinking that way, but they may. I think that would be a 

valid issue for us to say, ‘‘Okay, if we are creating more procedures, 

then we’re going to pay for it.’’

We are going to have to come to that same issue, I suppose, with 

pharmaceuticals. They are costing more. They are costing you more 

on the one hand, and they are probably, if they do what they say 

they are going to do, my Zocor, which is very expensive, means you 

are less likely to get me into some heart program where you make 

a lot of money on me. 

The next thing is, what are we going to do about boutiques? As 

we balkanize your hospital, so all the cardiologists in Danbury say, 

‘‘Uh-uh, we’re going to create our own heart hospital,’’ they are 

going to thumb their nose at you and pull a lot of your good revenue, high-margin revenue, out. 

All of these things face you. It doesn’t happen in the veterans’ 

hospitals, I don’t suppose, now, but I hope that you will work with 

us to address that. I don’t think it does us any good. I mean, I 

think the balkanization thing hurts teaching hospitals, in which I 

have a lot of faith, and managed care plans, they aren’t going to 

teaching hospitals if they can avoid it because it costs them more. 

I think that in this overall review of safety we have to help you, 

but you have got to be willing to work with us. I mean, we can’t 

just say no, we are not going to have regulation, because then we 

are not going to get a universal computer language. 

I mean, you have to be willing to trust us that we won’t impact 

too much, and we have to trust you that you are not going to just 

come and hit us all the time for more capital. When I will tell you, 

you ought to be thankful that Danbury is not in California, because 

retrofitting California hospitals for Earthquakes, we are looking at 

$8 or $9 billion. Our hospitals, they are doing pretty well but not 

that well. 

So, I mean, there is a shared responsibility here, and I assure 

you that while some of us may be more skeptical than others about 

absolute tort reform, I have no quarrel with the idea of no-fault. 

I mean, I wrote the original bill for the District of Columbia, and 

driving in this city with no-fault auto insurance, and you would 

wonder about what we were doing those many years ago. It can 

work, as long as you leave the outlier for the gross negligence, because I think that threat has a salutary effect on those chief executive officers who may not just completely want to do this out of the 

goodness of their heart. 

So, thank you for being here. Please push us, because this, we 

can talk this to death. There are some bills. Tell the Hospital Association to give us their bill. I mean, the Secretary can get to the 

drafters of legislation more quickly than I can. Let Secretary 

O’Neill draft a bill for us and send it over. I will introduce it for 

him, but we have got to get going. 

I mean, this process, we won’t please everybody, so I will just 

shut up and say that the secret is when all of you are frowning, 

40

Ms. Foley, Dr. Miller, Dr. Berwick. Then we have got the right bill. 

If anybody is smiling, somebody got away with something. So let’s 

get you all frowning, drop the gavel and say, ‘‘Go forward with a 

bill.’’ I really hope we could do it. Thank you very much. 

Thank you. 

Mr. CAMP. [Presiding.] Thank you. I just have a couple of questions. 

Dr. Berwick, you were the author of this groundbreaking study 

on this issue which said that preventable medical errors are the 

eighth leading cause of death in America, accounting for as many 

as 98,000 mortalities in hospitals each year, and I think this only 

gives us a window on hospital deaths and does not really include 

the number of patients injured. Do you have an estimate of the 

number of patients that are harmed or killed as a result of medical 

errors in America each year? 

Dr. BERWICK. I don’t have it, nor does any such estimate exist 

that I know of. The eighth leading cause of death figure is attached 

to the estimate of 44,000. If it is 98,000, it is the fourth leading 

cause of death, just hospital injuries. What we do know is that certain forms of ambulatory surgery centers are quite unsafe. We 

know there are injuries in nursing homes. 

The other calculation that would be great to see would be deaths 

and injuries due to quality failures beyond safety hazards, for example, the failure to use the best-known medication or the failure 

to use the proper diagnostic procedure. That is not called an error 

in the errors report. That is a different kind of failure, and my own 

estimate is that there are many times that number of people who 

are suffering unnecessarily because of quality failures as there are 

of the more confined area of just errors. 

Mr. CAMP. So, then how serious would you say this problem is? 

Dr. BERWICK. The biggest opportunity for improving the health 

status of Americans, beyond prevention of disease, is to improve 

the quality of health care. 

Mr. CAMP. Dr. Feinstein, you mentioned that obviously if Federal policy doesn’t have quick fixes, in your testimony, and relies 

less on mandates and punishment and more on what you called 

learning networks, what would be the ideal components, just to 

summarize, of an error reporting system? 

Dr. FEINSTEIN. Well, error reporting systems and new technologies are tools that become part of a general quality and process 

improvement framework. I don’t want to in any way miss the opportunity to say that databases are very important. Protections so 

that someone can enter data on problems, all problems is critical. 

It is how Alcoa became the best in the world. Even more important 

is to embed all of these into a process improvement framework. 

This is what I would encourage the Federal government to do. We 

need to create in health care the same total safety environment 

that you have in aviation and the nuclear power industry. 

That involves research and education efforts directed at understanding, for everybody involved in a health enterprise, how to create a quality and a safety-focused environment. Systems need to 

keep learning how to move continuously toward improved safety, 

and more application of what we know to be good practice. The 

partnerships we have had with CMS, AHRQ, CDC, to date have 

41

helped us to build this improvement framework, to understand 

what works, and also how you are continually, as you introduce 

new technologies and as you gather more data, you are continually 

coming up with new problems. 

Mr. CAMP. All right. You have mentioned that you believe State 

peer review statutes are inadequate, and why do you think that is 

so, and is that why you think we need a single national standard? 

Dr. FEINSTEIN. I will speak from our own example—our Pennsylvania State peer review statutes are good. The Medicare protections through our Quality Improvement Organization, QIO, are 

very good, but involves only the Medicare population. Hospitals are 

treating a very broad base of patients. We want to learn from all 

our errors, all our problems. Every one is significant, even the ones 

that are minor, even the ones that don’t hurt people. 

Mr. CAMP. Thank you. The gentlewoman from Florida. 

Ms. THURMAN. Thank you, Mr. Camp. I apologize for not being 

here for all the testimony, but we have this little stimulus package 

on the Floor today that we seem to all be concerned about and 

want to see something done with. 

Beyond that, I probably just want to get some ideas from all of 

you. I don’t know if you are familiar with a piece of legislation that 

Mr. Houghton and I have introduced on medication errors. It is actually—and it is being done by Senator Graham from Florida and 

Olympia Snowe in Maine, and there are a few differences but not 

much of a difference. 

I am curious because we think, at least looking at the numbers, 

medication errors seems to be a very high part of any of this system that we are concerned about. Some of the numbers we have 

seen, that there have been approximately 7,000 deaths, some 

250,000 nonfatal injuries. What I also find interesting about it is 

that by doing some of this, and I think you all have alluded to this, 

that because of this that it costs about $4,700 per patient admission because of these issues. 

So, we put a piece of legislation together specifically to look at 

technology, the kinds of things we can do with technology. Jim, I 

know that you all have done much of this at the Michigan VA, and 

DOD has similar technology. I happen to have had the experience 

of my mother being at Walter Reed. They have a wonderful system 

going on out there. It is all computerized. Doctors know what is 

going on. Everything goes into the computer, the patient’s information, what medicines and all those kinds of things. I was fascinated 

by what had happened out there, and certainly the VA hospital in 

Gainesville and others have implemented some of that. 

What we are trying to do is actually give about $1 billion over 

a 10-year period of time to help hospitals and nursing homes, because we think skilled nursing facilities have got to be in this mix, 

and we also have taken a part of these dollars and we have carved 

out about 20 percent of those dollars going to rural health areas, 

because that too is something we think is absolutely necessary. 

Then we have actually tried to work on a board that would be 

called the Medical Information Technology Advisory Board, specifically because we also think that as we get this information, as we 

are using with the patients, as it is working, we also know that we 

want to be able to transmit this information so in case somebody 

42

needs the information for follow-up on somebody. We also recognize 

there is information, privacy issues come up, privacy issues that 

become a concern, and so the difference between Senator Graham’s 

and our bill basically is that issue. 

There will be some criticism of this bill because funding comes 

out of the Medicare Trust Fund. I don’t want that to be where it 

comes. That just seems right now the best place that we can look 

for the dollars. We think it is a good investment, potentially saves 

money, and certainly would like to work with any of you on this 

issue. Certainly, based on your comments, there is not money in 

these hospitals. There is not anything to be able to be done with 

capital improvements. That is going to create a problem. 

Just based on my explanation of what we have done here, can 

you give me a little bit of feedback on whether you think that this 

might be something that could work, would be helpful, and what 

we can do to get this moving? 

Dr. BERWICK. I will start. I am sorry, I was aware of it as the 

Graham-Snowe bill. I think it is a good idea. I think it would at 

least get some acceleration into the system. 

Here are two ideas. One is, continue as you are to make sure the 

money goes where the need is. Industry ought to be obligated to 

obligate capital to this when it can afford it. So as long as you are 

targeting rural, small areas, hospitals that are in underserved communities, I am happier that we are not offering money where it 

won’t make a difference. 

The second is an idea I have got. I have no way to know how 

to put it in the legislation, but I think it is a good idea. Why reinvent the wheel over and over and over again for a thousand rural 

hospitals, or if you want to go to physician offices, for 20,000 physician offices? 

Could it be a government task to fund and create a single national default option which is available at extremely low cost as the 

basic system, so we could say to rural hospitals or to physicians’ 

offices, ‘‘You can have this one. The VA built it. They put the 

money in. It’s your money. It’s your tax dollars.’’ Or if not VA, 

someone else. ‘‘It’s yours. You can have it for free. If you want to 

buy something with higher end or higher functionality, of course 

feel free to invest money further.’’

No one is going to do that, and it would really accelerate the action a lot. We have spent public dollars on wonderful systems that, 

with some adjustment and some investment, perhaps under your 

legislation, could become a national gift, I guess, to the system that 

is having trouble getting over this capital threshold. It would save 

in aggregate nationally lots of money, because then we won’t have 

a thousand places doing a thousand different things. We will have 

one system that everyone can use. 

Mr. CAMP. Just quickly, we do have a recorded vote with 8 minutes left, so if you could just quickly sum up. 

Dr. MILLER. A couple of quick points. I am interested in the legislation. I don’t know all of its details. I am a little anxious about 

designation of dollars more to rural hospitals. I would want to 

make sure we are putting the dollars where they need to be. 

Ms. THURMAN. It is 20 percent. It just carves it out of 20 percent, so they don’t get left out of the system. 

43

Dr. MILLER. They shouldn’t be, but the middle-size community 

hospital is often the one that should have more complicated systems in place, because it is big enough and may not have the resources. 

The source of dollars is always problematic. We talked earlier 

aboutsources. Taking it out of Medicare funds is just going to take 

it out of one pocket and put it in the other. It is not going to solve 

my problem. 

The third, I will be brief, but it is an issue. The whole business 

of cost savings with new technologies, I believe in it, I believe in 

that $4,000 figure. I have read the studies. I think those savings 

are way down the line, and they are illusive. The Advisory Board 

has published four stars for quality for physician order entry, and 

that is why we should do it; one star for cost savings. That will be 

hard to achieve. 

Ms. FOLEY. I will sum very quickly, as well. Thank you. I 

haven’t looked at the bill, but it sounds good, because the most difficult position that good administrators are put in is to choose 

where to spend their money. If they have to choose between technology and adequate staff, that is a terrible position to put good 

people in, so additional incentives for the pursuit of the technology 

while we also provide the adequate funding for the people. 

The U.S. Pharcacopeia, USP, study showed that primary contributing factors to medication errors were distractions and work load 

increases. So, though we know there are some savings and error 

prevention to be achieved, we don’t want to just go off in one direction. That is why that system approach, which is what we are all 

about, is very good. It sounds very exciting. Thank you. 

Ms. THURMAN. Thank you all very much. 

Mr. CAMP. All right. I want to thank you all for your very helpful testimony, and this Health Subcommittee hearing on health 

quality and medical errors is now adjourned. 

[Whereupon, at 12:31 p.m., the hearing was adjourned.] 

[Submissions for the record follow:]

Statement of the American Academy of Family Physicians, Leawood, 

Kansas 

Introduction

This statement, submitted to the Ways and Means Health Subcommittee regarding patient safety and health care quality is offered on behalf of the 93,500 members 

of the American Academy of Family Physicians (AAFP).

The Academy Finds the Creation of a Non-Punitive Environment a Mandate for Safety Reporting

The Institute of Medicine’s report, To Err is Human, released in December 1999, 

highlighted the unacceptable frequency of health care errors. All patients need to 

know they can rely on their physicians to do the utmost to bring about the best possible medical outcome. Such assurance requires that patients are as free as possible 

from harm due to medical errors, regardless of the setting. Unfortunately, the IOM 

study makes clear that adverse events occur with unacceptable frequency. It is timely and appropriate for this aspect of quality in the delivery of health care to become 

the focus of nationwide attention and efforts for improvement. Today’s hearing focuses on how Congress can help initiate a patient safety reporting system to promote quality health care. 

In the US, most healthcare contacts are made in office settings; most office-based 

care is primary healthcare; and family physicians provide more primary healthcare 

than any other specialty. In 1998 in the US, there were 39 million hospital discharges and 829 million outpatient visits, suggesting that ambulatory care may hold 

44

an even more important opportunity for improving patient safety. A recent study 

of the ecology of medical care confirms this large, relative difference in exposure to 

outpatient and inpatient care. This study, based on data from the Medical Expenditure Panel Survey (a nationally representative, longitudinal survey sponsored by the 

Agency for Healthcare Research and Quality), found that for every one thousand patients in a month, 217 would be seen for a medical condition in the outpatient setting and only eight to nine individuals would be hospitalized. 

Three years ago, the AAFP made a $13 million commitment to improving the research infrastructure for primary care ($7.7 million for three Centers, and $5.3 million for the Robert Graham Center for Policy Studies in Family Practice and Primary Care). In the last year, that investment contributed the first US study of errors in ambulatory care. The Robert Graham Center and the AAFP National Research Network learned from 43 practices across this country what physician-reported errors look like. These findings are currently in peer-review at the international journal, Quality and Safety in Health Care. The Academy recently launched 

a six-country study to look at errors in similar clinical settings in the U.S., New 

Zealand, Canada, the Netherlands, Australia and England so that patient safety 

and quality improvement projects could benefit from comparison with other countries. 

The Academy has been awarded an innovation grant from the Agency for 

Healthcare Research and Quality (AHRQ) to develop a Center of Excellence that 

will identify, test, and disseminate strategies for making primary health care safer. 

One strategy already in use is a computer web-based anonymous error reporting 

system that has so far proved effective not only in identifying threats to patient 

safety but also in improving more general aspects of primary health care quality. 

The success of the Academy’s error reporting system beyond initial testing stages 

will depend upon Congressional efforts to ensure that information reported remains 

confidential, is protected from use in legal actions and will not be used in separate 

punitive actions as a result of a report having been filed. 

Finally, the Academy believes that there is a need for error-reporting systems 

that are ‘‘open, discussible and without blame,’’ in the words of Dr. Donald Berwick, 

one of the IOM study authors, and an invited guest of the Subcommittee. Only by 

researching the underlying cause of medical errors, creating effective interventions 

and addressing future prevention, can the IOM’s call for a 50 percent reduction in 

the rate of medical errors over the next five years be realized.

Additional Principles That Need to Be Incorporated into Patient Safety 

Legislation

The Academy supports the following principles as integral to creating a learning 

culture that actively seeks to improve the delivery of health care. 

Analysis and Feedback

Reporting systems cannot become warehouses of data. Information submitted to 

reporting systems must be the basis for conducting analysis that results in changes 

being made to practice. When effective procedures are developed to respond to the 

underlying cause of patient safety events, they should be compiled and widelydisseminated to all healthcare professionals and organizations. 

Confidentiality

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. 

45

Legal Status of Reporting System Information

Congress should create new federal protections for information submitted to patient safety reporting systems. Informationdeveloped in connection with reporting 

systems should be privileged for purposes of federal and state judicial proceedings 

in civil matters, and for purposes of federal and state administrative proceedings, 

including with respect to discovery, subpoenas, testimony, or any other form of disclosure. This new privilege should not interfere with the availability of records that 

would be otherwise attainable, including patient access to their own medical record. 

Conclusion

The Academy appreciates this opportunity to submit a statement to the subcommittee and looks forward to working with Congress to develop effective patient 

safety legislation. This is a matter of continued interest to AAFP and we thank the 

Ways and Means Health Subcommittee for its interest in the topic.

The American Academy of Orthopaedic Surgeons (AAOS), representing 18,000 

Statement of the American Academy of Orthopaedic Surgeons 

f 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 wrongsite 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 

46

societies and federal agencies that will focus on community based and national collaborative initiatives for implementation of patient safety improvements. A major 

charge to the Committee will be the continued education of AAOS members to 

achieve a culture of safety within their practice and to incorporate patient safety 

considerations into practice guidelines. 

AAOS also remains a recognized leader in the process of Continuous Quality Improvement (CQI), an important cornerstone of our strategic plan that helps us provide ‘‘Best Care’’ to our patients. We have developed a comprehensive patient education program that will empower patients by encouraging them to take control of 

managing their own health care and increased communications to the public about 

the AAOS’ own commitment to this effort. The AAOS Committee on Evidence Based 

Medicine remains focused on developing clinical practice guidelines and performance 

measures to improve quality and efficiency of care, which can be used to assist physicians in diagnosis and treatment decisions. 

In addition to our internal education efforts, we continue to look beyond our own 

organization to work with Federal agencies and other health care organizations that 

support efforts to reduce medical errors. The Department of Health and Human 

Services’ Agency for Healthcare Research and Quality (AHRQ) dedicated itself 

under the leadership of Director John Eisenberg, MD, to conduct and disseminate 

research in order to improve the outcomes, quality, access, cost and utilization of 

health care services. We have maintained a dialogue with key AHRQ staff to continue to provide input into their research efforts and medical error projects, and 

AAOS Fellows have participated in discussions surrounding the formation of a key 

AHRQ initiative, the Patient Safety Task Force. This Task Force has begun to 

evaluate and explore ways to minimize the burden of reporting adverse events and 

errors and to explore the development of a single, coordinated system for collecting 

data that would be easy to use and would provide reliable, valid information. 

We are active participants in the National Quality Forum (NQF), a not-for-profit 

public-private membership organization established to develop and implement a national strategy for health care quality measurement and reporting. AAOS remains 

committed to participating in the Ambulatory Surgical Care Consensus Project of 

the National Patient Safety Foundation, a broad-based partnership of health care 

clinicians, consumer advocates, health product manufacturers, public and private 

employers and payers, researchers, regulators, and policymakers. 

AAOS, as part of a large group of national health care organizations, developed 

a set of key principles and safeguards that we believe should be incorporated into 

voluntary patient safety reporting systems. 

These principles call for: the creation of a non-punitive environment for safety reporting that focuses on preventing and correcting systems as opposed to laying 

blame on individuals or organizations, a comprehensive analysis of data to identify 

where improvements can be made and new protocols should be developed, assurance 

of confidentiality protections for patients, healthcare professionals and organizations, the ability to disseminate and share patient safety information to facilitate 

positive improvements, and federal protection for reporting system information. We 

believe it is critical that data collected and shared for the purposes of improving patient safety be privileged, or use of patient safety reporting systems may ultimately 

be discouraged. (Please see attached listing of principles.) 

As the Subcommittee evaluates appropriate responses to prevent patient harm 

and minimize health systems errors, policies should encourage a constructive partnership between the federal government, hospitals, physicians, and other medical 

providers and personnel. These public and private initiatives should be encouraged 

through a non-punitive, cooperative environment, and should take a system-wide 

approach that ensures patient confidentiality and appropriate legal protection of all 

information involved in patient safety reporting systems. Before instituting new reporting systems, AAOS encourages federal and state governments to determine 

through initial, scientifically sound research whether and how existing reporting 

programs have led to a reduction in medical errors. 

AAOS thanks Chairman Johnson, and the members of the Subcommittee for holding this important hearing. We stand ready to work with the Subcommittee and 

other Members of Congress to ensure safe practices in our health care system. 

General Principles for Patient Safety Reporting Systems 

1. Creating an Environment for Safety. There should be a nonpunitive culture 

for reporting healthcare errors that focuses on preventing and correcting systems failures and not on individual or organization culpability.

47

• Healthcare 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.

• Systems within organizations should be scrutinized to identify weaknesses 

and processes that make healthcare errors possible or likely to occur, and 

to identify actions to prevent future errors. Effective procedures and/or protocols developed through reporting systems should be compiled and widely 

disseminated to all healthcare professionals and organizations.

3. Confidentiality. Confidentiality protections for patients, healthcare professionals, and healthcare organizations are essential to the ability of any reporting system to learn about errors and effect their reduction.

• 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.

4. Information Sharing. Reporting systems should facilitate the sharing of patient safety information among healthcare organizations and foster confidential collaboration with other healthcare reporting systems.

• 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. Sharing of 

error-related information is subject to the confidentiality principle. 

• The causes of errors and their solutions must be widely shared so that all 

healthcare organizations can learn from the experiences of others. 

• In some circumstances, it will be desirable to share reports of errors among 

reporting systems, and with other appropriate quality improvement entities, in order to accomplish root cause analyses, to construct action plans, 

and to engage in other efforts to enhance patient safety.

5. Legal Status of Reporting System Information. The absence of federal protection for information submitted to patient safety reporting systems discourages the 

use of such systems, which reduces the opportunity to identify trends and implement 

corrective measures. Information developed in connection with reporting systems 

should be privileged for purposes of federal and state judicial proceedings in civil 

matters, and for purposes of federal and state administrative proceedings, including 

with respect to discovery, subpoenas, testimony, or any other form of disclosure.

(a) Scope. The privilege for the information prepared for a reporting system 

should extend to any data, report, memorandum, analysis, statement, or other 

communication developed for the purposes of the system. This privilege should 

not interfere with the disclosure of information that is otherwise available, including the right of individuals to access their own medical records.

(b) No Waiver. The submission of healthcare error information to a reporting 

system, or the sharing of information by healthcare organizations or reporting 

systems with third parties in accordance with these principles, should not be 

construed as waiving this privilege or any other privilege under federal or state 

law that exists with respect to the information.

(c) Freedom of Information Act. Healthcare error information received by 

and from reporting systems should be exempt from the Freedom of Information 

Act and other similar state laws. Such an exemption is necessary to preserve 

the privilege discussed in this principle.

(d) Impact on State Law. A federal law is necessary to assure protection of 

information submitted to national reporting systems, but the federal protection 

should not preempt state evidentiary laws that provide greater protection than 

federal law. Providing such information to reporting systems should not constitute a waiver of any state law privilege.

f

48

Statement of the American Academy of Pediatrics 

The American Academy of Pediatrics is pleased to provide a statement to the Subcommittee on Health of the Committee on Ways and Means on issues of great importance to pediatricians—Health Quality and Medical Errors. 

Pediatricians provide the highest quality care to infants, children, and adolescents 

but the Academy acknowledges that there are opportunities for improvement. Our 

goal is to minimize errors and maximize quality. The June 2001 policy of the Academy ‘‘Principles of Patient Safety in Pediatrics’’ provides direction on setting up 

processes to identify and learn from errors, developing performance standards and 

expectations for safety, and promoting leadership and knowledge (attached). 

Patient safety may be broadly defined as including medication use (medication errors and adverse drug events [ADEs]), wrong or delayed diagnosis, surgical errors, 

birth injury or nosocomial infection. Infants and children are at increased risk for 

harm because of their limited reserves and the increased opportunities for error entailed by weight-based dosing for virtually all pediatric medications. Because there 

is very little published research about pediatric patient safety issues, it is imperative that the Agency establishes a specific research agenda focusing on patient safety issues in the pediatric population. 

Background: Medication Errors in Pediatrics

An important component of patient safety is medication error. The Institute of 

Medicine report, ‘‘To Err is Human,’’ suggests that medication errors are the most 

frequent type of patient safety error. Little research has addressed the problem of 

medication errors and adverse drug events in pediatric settings. The lack of pediatric studies is unfortunate because children pose unique challenges, including increased opportunities for error entailed by weight-based dosing for virtually all 

medications, and the potential for more serious consequences of drug errors due to 

the limited reserves of smaller children. 

Hospital Settings for Pediatric Care

In a study of complex errors in hospital prescribing, one researcher demonstrated 

that the likelihood of drug error is an exponential function of the number of drugs 

administered. A hospitalized pediatric patient receives an average of seven medications. The errors most frequently recognized in association with hospital pediatric 

drug therapy include computation errors of dosage and dosing interval, errors in 

drug orders (including written instructions and interpretation), and errors in drug 

preparation or conflicts with prescribed dosages. Children are at particular risk for 

these types of errors, as the broad range of patient age and size requires dosage 

individualization, most often using dosage equations. 

Drug dosages for children are calculated on a per weight basis that is significantly 

different from calculating dosages for adults. A computation error can result in a 

significant under or over-dosage. One medication safety issue especially harmful in 

pediatrics is commonly referred to as the ‘ten-fold’ error (e.g., a misplaced decimal 

point can mean a ten-fold change in the appropriate dosage of medication). One example dramatically illustrates this type of error. Jose Eric Martinez was an ill twomonth-old who exhibited early signs of congestive heart failure. In order to ameliorate his condition, the physician ordered intravenous Digoxin over aseveral day 

stay. However, because of a decimal point error in determining the appropriate dosage, the infant was given a dose that was 10 times what was intended and died. 

In order to better structure appropriate interventions, it is critical to understand 

which pediatric age groups experience adverse events most frequently. The Harvard 

Risk Management Foundation, with significant experience in children’s hospital settings, suggests that there may be particular drug distribution and administration 

challenges in patients weighing less than 5 kilograms (personal communication, 

Frank Federico). Research is needed to confirm these findings and to support the 

development of interventions that focus on clinical decision-making and the use of 

alternate medications to improve care and decrease errors. 

In the only study documenting the epidemiology of medication errors in a children’s hospital setting, Rainu Kaushal, MD and her colleagues found that serious 

pediatric medication errors (potential adverse drug events and preventable adverse 

drug events) occurred at a three-fold higher rate than in adults. This study provided 

important confirmation of the unique epidemiology of medication errors in pediatric 

inpatient populations and suggests that hospitalized children are at a greater risk 

of serious medication errors than adults are. This finding gives additional emphasis 

to the need for study of appropriate interventions in the pediatric population. 

In a review characterizing the nature and potential consequences of actual prescribing errors involving dosage equations at a tertiary care hospital, Timothy 

49

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, preschools and many child daycare settings. In fact, after the home, schools and 

preschools are the most common locations for medication administration to children 

50

to occur. Systems of medication delivery at such institutions are too often sub-optimal or do not exist at all. The presence of school nurses increases the likelihood that 

a school district has a medication-delivery and recording protocol; however, the presence of school nurses is highly variable. In addition, childcare settings for infants 

and toddlers rarely have any support for health matters and little monitoring by the 

state agencies. Research on errors in these settings should be a priority. In addition, 

research is needed to design, promote, and implement standardized protocols for 

medication delivery in schools, preschools, child care centers, and family-based child 

day care homes. 

Information Technology

Information technology has great potential to minimize medication errors. Computerized order entry has been shown to decrease errors. In addition, this technology offers the opportunity to coordinate care given by multiple individuals to a 

single pediatric patient. It is imperative that research examine the many uses of 

information technology in improving patient safety as well as how to influence clinician acceptance of information technology in both the ambulatory and inpatient settings. 

Safe and Appropriate Use of Medications in Children

The safety of medication use in the pediatric population represents an important 

area of research need. This knowledge could minimize the risk and maximize the 

quality of care that children receive. The following are important topics for research: 

Psychotropic drug use in children. 

To determine the prevalence of psychotropic medication use in preschool-aged children, JM Zito, MD and colleagues analyzed ambulatory care prescription records 

from two state Medicaid programs and a salaried group model health maintenance 

organization (HMO). It was discovered that the number of psychotropic medications 

prescribed for preschoolers increased dramatically from 1991 to 1995. The use of 

stimulants, the most common class of drugs prescribed, increased three-fold in this 

age group during the early 1990s. These findings are especially remarkable due to 

the limited data on the efficacy and safety of psychotropic medication use in children. Epidemiologic studies are needed to evaluate clinical and treatment outcomes. 

Clinical trials are necessary to evaluate dosages, efficacy, and safety of certain drugs 

not approved for a pediatric age group. 

Inappropriate use/overuse of antibiotics for otitis media (ear infections). 

Antimicrobials are the second leading therapeutic category of drugs prescribed by 

office-based physicians in the United States each year. According to the 1996 

NACMS, antibiotic prescriptions reached 128 millions doses compared to 86 million 

in 1980. From 1990 to 1992, almost one in six physician office visits resulted in antimicrobial prescription. In 1992, more than 6.5 million prescriptions were written for 

children with a cold or upper respiratory infection. 

Otitis media is the leading indication for outpatient antimicrobial use in the 

United States. Overdiagnosis of and unnecessary prescribing for otitis media has 

contributed to the spread of antimicrobial resistance. In a recent prospective study, 

antimicrobial treatment of otitis media accounted for more than 90% of all antimicrobial use during the first two years of life. These data again underscore the increased risk children’s health and safety when they are needlessly exposed to 

drugs.Research is needed to help physicians better identify which children need 

antimicrobials, and how to most effectively change clinicians’ prescribing behavior 

for otitis media. Studies also have demonstrated that parents influence the physician’s decision to prescribe antimicrobials. Based on this fact, it is essential that research identify effective approaches to change parents’ expectations about the indications for antibiotics as well as how to improve physician-parent communication on 

this topic. 

Reporting Systems

Based on the recommendations in the IOM report, state and national policy makers have begun to examine the role reporting systems play in reducing medical errors. However, there are significant external barriers to implementing effective reporting systems. The blame and punish philosophy and the search for individual 

culpability still persists. This is an obstacle to openly discussing or reporting errors. 

Reporting programs should be aimed at ensuring that health systems are safe for 

children. To do so, the reporting systems should be non-punitive, ensure anonymity, 

focus on system failures, recognize that adverse events may or may not be caused 

51

by errors, and support the key role that organizational leadership plays in systems 

improvement. 

To promote effective reporting systems that are designed to maximize patient 

safety, the Academy recommends AHRQ support research that will provide information to guide decision-making on the following issues:

• Understanding 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. • Determining the effectiveness of interdisciplinary safety teams with leadership sanctions in improving either rates of medical error reporting or 

changes in patient care systems. • Examining the effectiveness of state reporting systems on reducing medical 

errors in pediatrics, including determining whether states that require 

mandatory board reports with disciplinary action have lower rates of medical error reporting. • Exploring 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. • Exploring best ways to encourage reporting. Defining the impact of the 

error debate on families’ satisfaction with health services. 

Summary

In summary, the American Academy of Pediatrics urges the Congress to work 

with the medical community to address the following patient safety issues in the 

pediatric community:

• Testing 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. • Documenting 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. • Documenting the epidemiology of pediatric medication errors in childcare 

and school settings. • Developing and testing interventions to improve medication systems in 

both inpatient and ambulatory settings. • Designing, promoting, and implementing standardized protocols for medication delivery in schools, preschools, childcare centers, and family-based 

child day care homes. • Developing and testing effective reporting systems. Researching how to influence clinician acceptance of computerized order entry systems in both 

the ambulatory and inpatient settings. • Studying the use of computer technologies as tools to minimize drug errors 

or as aids in coordinating care provided by multiple individuals. 

REFERENCES AVAILABLE UPON REQUEST. 

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

Policy Statement 

Pediatrics 

Volume 107, Number 6 

June 2001, pp. 1473–1475

Principles of Patient Safety in Pediatrics (RE060027) 

AMERICAN ACADEMY OF PEDIATRICS

National Initiative for Children’s Health Care Quality Project Advisory Committee

ABSTRACT. The American Academy of Pediatrics and its members are 

committed to improving the health care system to provide the best and 

safest health care for infants, children, adolescents, and young adults. In 

response to a 1999 Institute of Medicine report on building a safer health 

system, a set of principles was established to guide the profession in designing a health care system that maximizes quality of care and minimizes 

medical errors through identification and resolution. This set of principles 

provides direction on setting up processes to identify and learn from erVerDate Sep 04 2002 01:19 Oct 03, 2002 Jkt 081751 PO 00000 Frm 00055 Fmt 6633 Sfmt 6621 E:\HR\OC\B751.XXX B751
52

1 Committee on Quality Health Care in America, Institute of Medicine. In: Kohn LT, Corrigan 

JM, Donaldson MS, eds. To Err Is Human: Building a Safer Health System. Washington, DC: 

Institute of Medicine; 1999. 2 Hearings before the Subcommittee on Health Care of the House Committee on Veterans’ Affairs and the Subcommittee on Health and the Environment and the Subcommittee on Oversight and Investigations of the House Committee on Commerce, 106th Cong, 1st Sess (2000) 

(testimony of Donald Berwick, MD, member Committee on Quality of Health Care in America, 

Institute of Medicine). 

rors, developing performance standards and expectations for safety, and 

promoting leadership and knowledge. 

INTRODUCTION

The 1999 report of the Institute of Medicine, To Err Is Human: Building a Safer 

Health System, notes that errors in health care are a leading cause of death and 

injury.1 Between 3% and 4% of hospitalized patients are harmed by the care that 

is supposed to help them. On average, of 100 hospitalized patients, 7 are exposed 

to a serious medication error that harms or could have harmed them. It is estimated 

that between 44,000 and 98,000 Americans die in hospitals each year as a result 

of errors in their care.2 Although these figures have been challenged, there is no 

disagreement as to the importance of the topic or the existence of substantial safety 

concerns in health care. In response to the report, Congress and various states are 

proposing legislation and programs to improve patient safety. 

The increasing complexity in patient care in addition to the public’s increased 

scrutiny of the health care system underscores the need to make patient safety an 

issue of high priority. The American Academy of Pediatrics and its members are 

committed to improving the health care system to ensure that infants, children, adolescents, and young adults receive the best and safest health care. 

All health care systems should be designed to prevent errors. The first step in designing these systems is to identify errors and study their pattern of occurrence 

within delivery systems to reduce the likelihood of adverse events. A specific concern 

in pediatrics is the lack of information on errors in the pediatric population and the 

strategies needed to minimize errors and maximize care in both the ambulatory (including schools and child care settings) and inpatient sectors. If the Academy is 

going to implement an effective and far-reaching agenda to address the public policy 

and research components of the patient safety debate, the set of principles listed 

below should serve as its guide.

RECOMMENDATIONS FOR IDENTIFYING AND LEARNING FROM ERRORS

1. Pediatricians are committed to bringing about the best possible health outcomes for children and their families. Because all medical interventions involve known and unknown risks, pediatricians should work with health 

care teams to create safe patient care environments and prevent medical 

errors. 

2. Efforts to improve patient safety and prevent errors should focus on a systems approach. Existing research on hospital-based care reveals that medical errors rarely represent the failure of an individual caregiver. Most errors in medical care are systems errors related to equipment, complex 

processes, fragmented care, and lack of standardized procedures. 

3. Systems 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:

• Be nonpunitive; 

53

3Kaushal R, Bates DW, Landrigan C, et al. Medication errors and adverse drug events. 

Pediatr Res. 2000;47:201. Abstract 1188. 

• Require that only the most critical events be subject to mandatory reporting; • Require that information reported to internal and external patient 

safety review groups should not be discoverable in civil or criminal 

legal action; • Allow individuals involved in the events to remain anonymous whether 

or not error is involved; • Recognize that adverse events may or may not be caused by errors; • Focus on systems failures; and • Support the key role that organizational leadership plays in systems 

improvement.

3. Most research on medical errors is hospital based. It may not be appropriate to extrapolate the number or types of errors found in hospitals to 

the number or types of errors that might be found in ambulatory health 

care settings. Because most health care is delivered in ambulatory care 

settings, and in pediatrics, many medications are taken outside of the 

home (in schools and child care settings), research on errors in ambulatory 

care settings should be a priority, particularly for unique patient populations, such as infants, children, adolescents, young adults, and children 

with special needs. The problem of drug dose calculation errors for pediatric patients, in particular, should be explored. 

RECOMMENDATIONS FOR DEVELOPING PERFORMANCE STANDARDS 

AND EXPECTATIONS FOR SAFETY

1. Patient 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. Health 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. Information 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. 

4. All individuals involved in providing health care to children should work 

together to:

• Develop and enforce standards for the design of drug packaging and 

labeling that will maximize safety in use; 

• Require pharmaceutical companies to test proposed drug names to 

identify and remedy potential ‘‘sound-alike’’ and ‘‘look-alike’’ confusions 

with existing drug names; 

• Establish appropriate responses to problems identified through postmarketing surveillance, especially for concerns that are perceived to require immediate response to protect the safety of patients; and 

• Support expanded efforts to include children in new drug trials. 

RECOMMENDATIONS FOR LEADERSHIP AND KNOWLEDGE 

1. The 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. 

54

2. Health 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:

• Provide strong, clear, and visible attention to safety; 

• Represent a collaborative effort of physicians, nurses, allied health personnel, and administrative staff who have experience with and knowledge of patient safety; 

• Incorporate well-understood safety principles, such as standardizing 

and simplifying equipment, supplies, and processes; 

• Implement proven medication safety practices; 

• Establish interdisciplinary learning programs; and Address the special 

needs of inpatient and ambulatory care environments.

3. Research that explores the effect the error debate has on families’ satisfaction with health care services should be conducted.

Promoting safety requires changing the culture of medicine to recognize that the 

potential for errors exists and that teamwork and communication are the basis to 

guarantee change. The promotion of patient safety and the decrease in the rate of 

errors should become one of the major goals of the Academy. Safety should be 

viewed as one component of a broader commitment to providing optimal health care 

for children—a goal that the membership embraces and that unites pediatricians 

with the families they serve.

NATIONAL INITIATIVE FOR CHILDREN’S HEALTH CARE QUALITY PROJECT 

ADVISORY COMMITTEE 

(NICHQ PAC), 2000–2001

Carole M. Lannon, MD, MPH, Chairperson 

Barbara Jane Coven, MD 

F. Lane France, MD 

Gerald B. Hickson, MD 

Paul V. Miles, MD 

Jack T. Swanson, MD 

John Ichiro Takayama, MD, MPH 

David L. Wood, MD, MPH 

Loren Yamamoto, MD, MPH

The recommendations in this statement do not indicate an exclusive course of 

treatment or serve as a standard of medical care. Variations, taking into account 

individual circumstances, may be appropriate. 

Copyright  2001 by the American Academy of Pediatrics. No part of this statement may be reproduced in any form or by any means without prior written permission from the American Academy of Pediatrics except for one copy for personal use.

The American Health Quality Association represents independent private organiStatement of David G. Schulke, American Health Quality Association 

f zations—known as Quality Improvement Organizations (QIOs)—that hold contracts 

with the Centers for Medicare and Medicaid Services (CMS) to improve the quality 

of care for Medicare beneficiaries in all 50 states and U.S. territories. 

Congress created the QIO network to monitor and improve the quality of care delivered to Medicare beneficiaries and supports the work of the QIOs with about $300 

million annually from the Medicare Trust Fund. In the early years of the program, 

QIOs were known as Peer Review Organizations and focused on oversight—on 

catching ‘‘bad’’ doctors and hospitals. However, over the past decade QIOs have dramatically changed their approach. 

QIOs today work directly and cooperatively with hospitals and medical professionals across the country to implement quality improvement projects that address 

the root causes of medical errors. QIOs today are working to accomplish what this 

committee—in its announcement of this hearing—suggests should be a major bipartisan goal: resolving endemic problems that result from failing systems of care. 

QIOs are improving the quality of health care not only by targeting errors of 

‘‘commission’’—medical errors that make the headlines—but also by systematically 

working with medical professionals to reduce errors of ‘‘omission’’ that result in care 

that falls short of evidence-based medicine. Examples of errors of omission include 

55

failure to administer antibiotics prior to major surgery, or failure to prescribe ACE 

inhibitor drugs to appropriate heart failure patients. 

Why The QIO Approach Works

QIOs are local organizations, employing local professionals, with a national mandate to improve systems of care. As such, QIOs act as catalysts for change trusted 

by both beneficiaries and providers. QIOs educate beneficiaries about preventive 

care and encourage hospitals and doctors to adopt and build into daily routines 

‘‘best practices’’ for treating seniors with common and serious medical conditions. 

Medical professionals work voluntarily and often enthusiastically with QIOs because QIO projectsreduce duplication of effort and burden on doctors participating 

in multiple hospitals and health plans. These projects also reduce the burden on 

hospitals that participate in multiple health plans, by bringing the parties together 

to work on the same urgent clinical priorities, using the same measures, the same 

abstraction tools, the same key messages. Even the best consultants working for individual hospitals cannot have this effect—and many providers cannot afford costly 

consultants. In short, QIOsaccelerate diffusion of evidence-based medicine to all providers—small, large, urban and rural. 

What QIOs Have Accomplished

QIOs use data to track progress towards eliminating errors and improving treatment processes. They use data to measure hospital and provider performance on a 

list of clinical indicators over the course of a QIO project, and then compare results 

to baseline data to document change. 

From 1996–1999, QIOs worked on local projects to improve clinical indicators in 

care for diseases and conditions that broadly afflict seniors—heart attack, congestive 

heart failure, stroke, pneumonia, diabetes, and breast cancer. Results from these 

projects show that QIOs have already made a significant difference. The latest 

available national data (1996–1998) show QIO projects resulted, for example, in:

• 34% more patients getting medications to prevent a second heart attack; • 23% more stroke patients receiving drugs that prevent subsequent strokes; 

• 12% more heart failure patients getting treatment needed to extend their 

active lives; 

• 20% 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:

Clinical Process 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:

Heart Attack Clinical Process Median State Improvement 

Prompt aspirin administration 16%

Aspirin at discharge 18%

Prompt beta blocker administration 26%

Beta blocker at discharge 26%

56

Pneumonia Clinical Process Median State Improvement 

Antibiotic within 8 hours 8%

Appropriate antibiotic administration 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. 

Recommendation

We urge the Committee to take closer note of what this program has accomplished 

and to verify its value through discussions with leaders of the medical community. 

We look forward to working with the Committee as it considers legislation to improve the quality and safety of Medicare. 

Confidentiality Requirements for

Medicare Quality Improvement Organizations 

The confidentiality of information collected or developed by a Medicare Quality 

Improvement Organization (QIO) is assured by Section 1160 of the Social Security 

Act. It was the intent of Congress in drafting this provision to provide safeguards 

for information identifying a specific patient, practitioner or reviewer. These safeguards foster an environment that is conducive to quality improvement efforts and 

learning from errors. 

Generally, the disclosure of data or information collected or developed by a QIO 

in carrying out its functions for Medicare is strictly prohibited. This information is 

not subject to subpoena or discovery for the purposes of an administrative or civil 

action. Further, the law states that any individual who violates the prohibition is 

subject to criminal fines and/or imprisonment. 

The law does provide exceptions for QIOs to disclose to specific individuals or entities information that may identify providers or practitioners. Under certain circumstances, QIOs may provide such information to the practitioner or the institution where the practitioner works, State licensure and certification agencies, fraud 

and abuse or public health officials. These entities may only disclose information obtained from a QIO in the context of a judicial, administrative or other formal legal 

proceeding resulting from an investigation conducted by the agency. All of these exceptions are for the intended purpose of identifying and protecting the public from 

substandard care, fraud or abuse. 

The confidentiality of QIO quality improvement efforts has helped establish a relationship of trust with providers. Currently, nearly 80% of Medicare hospitals nationwide are working with QIOs on one or more quality improvement projects. QIOs 

have also had some success working with outpatient physician offices, nursing 

homes and home health agencies. Efforts in the non-hospital settings will increase 

dramatically over the next few years. 

The QIO approach to improving care is voluntary, educational, collaborative and 

non-punitive. Through this approach, QIOs have assisted providers and practiVerDate Sep 04 2002 01:19 Oct 03, 2002 Jkt 081751 PO 00000 Frm 00060 Fmt 6633 Sfmt 6621 E:\HR\OC\B751.XXX B751
57

tioners 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.

f March 2002

Statement of the American Society for Clinical Pathology 

The American Society for Clinical Pathology appreciates this opportunity to comment on patient safety, an issue of great importance to the pathology and laboratory 

community. This statement focuses on patient safety initiatives within the pathology and laboratory medicine field, and shows how health care quality may improve 

as a result. 

The American Society for Clinical Pathology (ASCP) is a nonprofit medical specialty society representing 151,000 board certified pathologists, other physicians, 

clinical scientists (PhDs), medical technologists and technicians. It is the world’s 

largest organization representing pathology and laboratory medicine. As the leading 

provider of continuing education for medical laboratory personnel, the ASCP enhances the quality of the profession through comprehensive educational programs 

and materials. 

The purpose of the ASCP is to improve public health by advancing the science 

and practice of pathology and laboratory medicine. Patient safety is an important 

part of this principle. To continue its leadership role in advancing patient safety, 

ASCP has developed a Patient Safety Initiative, which encompasses every part of 

the laboratory. 

Transfusion Medicine Protocols

Transfusion medicine laboratory professionals have a long tradition for error detection and prevention systems by following standard operating procedures and conducting audits. While the proper application of these complex processes is critical 

to transfusion safety, dependency on numerous, diverse human interactions makes 

these processes prone to accidents and errors. Blood administration-related accidents and errors—which occur outside the confines of blood bank/transfusion service 

laboratory—represent a significant cause of transfusion morbidity and mortality. In 

the ongoing quest for improved transfusion safety, it is imperative that blood transfusion process safety be accorded the same emphasis as blood component safety. 

To address this issue, ASCP joined with the American Organization of Nurse Executives in a Patient Safety Transfusion Medicine Project Team to identify seven essential components of the blood transfusion process. The joint project team developed flow charts and standard operating procedure checklists to assist hospital personnel in assessing the status of their own processes and procedures and take necessary actions to close gaps that may compromise blood transfusion safety. The preliminary results of this joint patient safety project were unveiled last month at a 

workshop sponsored by the Food and Drug Administration and the Agency for 

Healthcare Research and Quality. 

Minimum Standards Necessary

The Centers for Medicare and Medicaid Services (CMS) found in a recent survey 

that 32% of waived laboratories failed to have current manufacturer’s instructions, 

16% didn’t follow the manufacturer’s instructions, 9% didn’t follow manufacturer’s 

storage and handling instructions, and 6% were using expired reagents and kits. 

This preliminary information is based on a survey conducted by CMS from October 

2000 to January 2001. The results showed overall that a substantial 48% of waived 

laboratories surveyed had quality testing problems. The survey results were produced from an expanded pilot project undertaken by the agency of 270 certificate 

of waiver laboratories and 190 provider-performed microscopy laboratories surveyed 

in eight states. 

Standards for clinical laboratory testing such as quality control, quality assurance, personnel standards, proficiency testing, and site neutrality should not be 

eroded as they have helped to raise the standard by which all laboratories operate. 

Problems that are identified can and are being corrected with the help and guidance 

of federal and private inspectors. 

58

Use of the Autopsy

The autopsy is an important quality control vehicle. For example, a study published in the August 1998 issue of the American Journal of Clinical Pathology found 

that of 176 autopsies examined in a major tertiary care transplantation referral center, 79 autopsies, or 44.9%, revealed one or more undiagnosed causes of death. 

There were 123 undiagnosed causes of death in the 79 cases. Of the 123 

undiagnosed causes of death, 13 were sole immediate causes of death, 72 were one 

of multiple immediate causes, 22 were intervening causes, and 16 were underlying 

causes of death. Low-technology autopsies frequently discover diagnoses that go undetected by modern high-technology medicine. Through the autopsy, problems in diagnosis may be recognized and ultimately assist in finding solutions to similar medical problems in future patients. 

To accommodate better the needs and concerns of family members, hospitals 

should develop a coherent set of policies that explain the usefulness of an autopsy. 

ASCP suggests that these policies may include: developing an informational pamphlet that is made available to the patient’s family, describing the autopsy procedure and its values; creating an office of decedent affairs within the hospital organization to assist dying patients, families and involved members of the medical staff 

to understand the details surrounding dying and death in the hospital environment; 

and creating in-service programs to ensure that nurses and social workers provide 

assistance in facilitating any efforts to obtain an autopsy consent. 

The ASCP firmly believes that the autopsy is necessary to monitor the clinical 

judgment in the medical community. For quality assurance purposes alone, the autopsy is a critical service. Any condition of participation addressing the autopsy 

should also assure appropriate compensation for this service. 

Second Opinions in Diagnostic Anatomic Pathology

As part of its Patient Safety Initiative, ASCP hosted the ‘‘Consensus Conference 

on Second Opinions in Diagnostic Anatomic Pathology: Who, What and When’’ on 

June 21, 2000, in Washington, DC. The conference, which was open to the public, 

convened with pathology experts of various disciplines, surgical representation, and 

a patient advocate. The conferees worked to reach a consensus on what specimens 

should be reviewed under second opinions, whose opinion prevails upon a second review, when a second opinion should occur, and to develop general guidelines for second opinions in diagnostic anatomic pathology. 

The conference determined that second opinion is an important component of total 

quality assurance programs in diagnostic surgical pathology and cytopathology and 

is a key aspect in the assurance of patient safety for tissue and cytology based diagnoses. The conference urged the implementation of educational programs to inform 

clinicians and patients regarding the value of second opinion; the turn around time 

delays which second opinion will produce, and the legitimate differences of opinion 

that can exist in difficult cases. 

It was recommended that all insurers provide a fair reimbursement structure for 

second opinion services, and that funding agencies support research into the detailed analysis of second opinion as a patient safety mechanism and that academic 

pathology centers should engage in such research. Overall, the effective use of second opinion in diagnostic anatomic pathology is a subject that needs to be better 

communicated to clinicians and patients. 

Conclusion

Pathology and laboratory medicine have developed and continue to support the 

use of quality processes for the systematic detection and prevention of errors. These 

efforts concentrate on building safety into the delivery of health care, similar to the 

recommendations of the Institute of Medicine Committee on Quality of Health Care 

in America. Many patient safety initiatives, such as those recognized in donor blood 

testing and autopsies, have been absorbed by the laboratory profession in the interest of maintaining and improving quality. As new efforts are disseminated, it will 

be important that custodians of those efforts receive the resources they need to accomplish the task. 

Thank you for the opportunity to provide this statement to the subcommittee.

Statement of the American Society of Health-System Pharmacists, 

Bethesda, Maryland 

f 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 

59

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, nonpunitive environment where errors can be reported, the underlying cause studied, 

and effective interventions devised and implemented. To do so, Congress must work 

with states and the private sector to create a single, nationwide error reporting program. 

In June 2000, ASHP’s House of Delegates approved the following statement regarding the development of an error reporting system: 

Policy

The incidence of death and serious harm caused by mistakes and accidents in 

health care is unacceptable. This serious public health problem merits top-priority 

national attention. Addressing this issue will require major reforms and sizable investment of resources throughout the health care system, including the medication 

use process, which is a particular focus of the American Society of Health-System 

Pharmacists (ASHP). 

ASHP believes that the following steps should be taken as part of a comprehensive national solution to the problem: (1) The establishment of a standardized, uniform nationwide system (with the characteristics noted below) of mandatory reporting of adverse medical events that cause death or serious harm, (2) continued development and strengthening of systems for voluntary reporting of medical errors, and 

(3) strengthening efforts to implement process changes that reduce the risk of future 

errors and improve patient care. 

The fundamental purpose of reporting systems for medical errors is to learn how 

to improve the health care delivery process to prevent these errors. Reporting of 

medical errors must become culturally accepted throughout health care. A major investment of resources will be required in the health care system to apply the lessons 

derived from the reporting of medical errors. Marshaling those resources is an urgent issue for the governing boards of health care institutions, health care administrators, health professionals, purchasers of health care (including federal and state 

governments), third party payers, public policy makers, credentialing organizations, 

the legal profession, and consumers. 

Requirements

The primary goal of mandatory reporting of adverse medical events that cause 

death or serious harm should be to foster accountability for health care delivery 

process changes to prevent errors or adverse medical events. If a patient dies or is 

seriously harmed because of a mistake or accident in the health care system, the 

practitioner or institution responsible for the patient’s care should report the incident to a designated state health body. Further, states should be obligated to share 

information based on these reports promptly with a national coordinating body and 

with national programs that are designed to improve the quality and enhance the 

safety of patient care. 

60

ASHP’s support of a mandatory reporting system is contingent upon the system 

having the following characteristics:

1. An overall focus on improving the processes used in health care, with the 

proper application of technical expertise to analyze and learn from reports, 

2. Legal protection of confidentiality of patients, health care workers, and the 

information submitted to the extent feasible while preserving the interest 

of public accountability, 

3. Nonpunitive 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. A definition of ‘‘serious harm’’ that concentrates on long-term or irreversible patient harm, so as not to overburden the reporting system, 

5. National 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. Adequate resources devoted to report analysis, timely dissemination of 

advisories based on report analysis, and development of appropriate quality improvement efforts, and 

7. Periodic assessment of the system to ensure that it is meeting its intent 

and not having serious undesired consequences.

Experience associated with current mandatory state reporting of adverse medical 

events and mandatory public health reporting of certain infectious diseases should 

be assessed, and the best practices of such programs should be applied to the new 

system of mandatory reporting of adverse medical events that cause death or serious harm. 

The primary goals of voluntary reporting of medical errors should be quality improvement and enhancement of patient safety. Reports by frontline practitioners of 

errors and ‘‘near misses’’ are a strength of such programs when report analysis and 

communication lead to prevention of similar occurrences. The public interest will be 

served if protection is granted to individuals who submit reports to voluntary reporting programs. The Medication Errors Reporting Program operated by the United 

States Pharmacopeia in cooperation with the Institute for Safe Medication Practices 

is an important initiative that merits strengthening; this program may be a model 

for voluntary reporting of other types of medical error. 

It is important to emphasize the necessity of nationwide peer review protections 

to the successful implementation of any error reporting program. ASHP supports 

‘‘federal legislative and regulatory initiatives that provide liability protection for the 

reporting of actual and potential medication errors by individuals and health care 

providers.’’ Further, ASHP supports ‘‘federal liability protection for medication-error 

reporting that is similar in concept to that which applies to reporting safety incidents and accidents in the aviation industry.’’

Since current legal protection for medication error reporting (both actual and potential as defined in ASHP’s ‘‘Guidelines on Preventing Medication Errors in Hospitals’’) is based primarily on state peer-review protection statutes or on case law, 

the extent of protection varies substantially throughout the country. For example, 

some states may limit protection to records prepared by peer-review committees and 

do not protect records provided to these committees. Given the state-to-state variance, medication errors may not be reported in a consistent and uniform manner, 

making trend analysis and subsequent corrective measures difficult. 

Individual practitioners and health care entities may be hesitant to report medication errors for fear that the information could be used in civil liability lawsuits 

against them. There is no federal protection for individuals and entities reporting 

medication errors to national reporting programs. This lack of protection, and the 

consequent incomplete reporting, means that individual practitioners, health systems, pharmaceutical manufacturers, and other public and private organizations 

cannot learn of the component parts of a system error and develop corrective measures to enable a fail-safe medication-use system. 

Such protection would only cover the information submitted to a designated national reporting entity. Individual practitioners and healthcare entities still would 

remain susceptible to liability action as a result of underlying incidents that form 

the basis of the report if the incident resulted in harm to an individual. 

Federal legislation providing liability protection for the reporting of actual and potential medication errors would neither help nor harm individual patients who are 

injured, but it should help patients collectively because the reported data could be 

used to reduce the incidence of avoidable errors. Individual patients would still be 

able to seek a legal remedy for their injuries. Seeking this limited federal protection 

is preferred over attempting to obtain uniform protection from all 50 states. 

61

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. 

Appropriate Application of Technology Improves the Medication Use Process

Everyone agrees that the number of medication-related errors is too high. Handwritten clinical data, incomplete, outdated or improperly implemented information 

technology increases the likelihood that this number will remain unnecessarily high. 

Research demonstrates that patient-safety geared information technology, when 

used appropriately and under the leadership of health-system pharmacists, who are 

responsible for the appropriate, accurate, and timely distribution of medications, can 

improve quality of care and reduce medication-related errors. 

The biggest obstacle for hospitals when it comes to implementing information 

technology enhancements is the enormous cost of researching these systems, purchasing the necessary hardware and software, as well as training staff to use the 

technology properly. 

The March 2001 IOM report, ‘‘Crossing the Quality Chasm: A New Health-System 

for the 21st Century,’’ urges a significant national investment in information technology geared toward improving the quality of health care delivery. 

ASHP supports a voluntary grant program that would provide funding for early 

adopters of new technology to meet the high price tag of this new technology as well 

as the necessary and important expense associated with properly educating and 

training staff on the correct use of the information system. The Medical Error Reduction Act (H.R. 3292), introduced last year by Ways and Means Committee members Amo Houghton (R–NY) and Karen Thurman (D–FL), would go a long way toward achieving this goal. Senators Bob Graham (D–FL) and Olympia Snowe (R–ME) 

have introduced similar bipartisan legislation (S. 824) in the Senate.

Recognizing Pharmacists as Health Care Providers Under Medicare Improves Quality of Care, Reduces Errors

Our nation’s health care system relies heavily on thousands of powerful new prescription medicines to treat all sorts of diseases and conditions. Many patients, especially those over the age of 65, find themselves taking a bewildering array of medications. As medication use rises, so to does the risk of medication-related complications. Yet, despite being among our nation’s highest risk patients, Medicare beneficiaries often have limited access to the valuable services of pharmacists. 

As the IOM and others have recognized, pharmacists play an important role in 

improving the quality of patient care and reducing the risk of dangerous (and costly) 

medication-related complications. Working closely and collaboratively with physicians, the pharmacist is a trusted counselor who helps to streamline drug therapies 

prescribed by a number of specialists, matching effective therapies with patients’ 

unique needs. Pharmacists also play vital roles in follow-up care, monitoring patient 

response and advising physicians on changes in dosage, medicine, or delivery method. 

Currently, Medicare does not compensate pharmacists for these important patient 

care services. Because pharmacists are not considered ‘‘health care providers’’ under 

Medicare, their experience is underutilized, patient care is diminished, and reductions in unnecessary expenditures are not realized. Simply put, Medicare payment 

policies have not advanced to match the pharmacist’s critical role in health care. 

ASHP supports the passage of legislation to update Medicare statutes to recognize 

pharmacists as health care providers in a similar manner as other non-physician 

practitioners, including registered dieticians, nurse practitioners, physician assistants, certified nurse midwives, and clinical social workers, are recognized. Legislation, the Medicare Pharmacist Services Coverage Act (H.R. 2799/S. 974), has been 

introduced in both the House and Senate to achieve this goal. This important legislation will ensure that the entire health care team is able to properly utilize the 

pharmacist’s expertise in drug therapy management. 

Conclusion

ASHP thanks Chairwoman Johnson, and members of the Subcommittee for holding this important hearing. We appreciate the opportunity to submit a statement 

for the record and look forward to working with the Subcommittee and other members of Congress to develop effective patient safety legislation.

f

62

Statement of Trace Devanny, Cerner Corporation, Kansas City, Missouri 

Madam Chairman and members of this committee, thank you for the opportunity 

to submit testimony outlining our views on the role of technology in improving 

healthcare quality and patient safety in the U.S. 

My name is Trace Devanny and I am the president of Cerner Corporation. We are a $543 million company with our headquarters located in Kansas City, Missouri. 

We are considered by many to be the world’s leading developer of clinical information systems software for the healthcare industry and our mission as a company is 

to transform healthcare through the implementation of information systems that 

improve healthcare quality and patient safety in the U.S. and around the world. 

I would like to take a moment to thank the members of this committee for focusing attention on this important issue in healthcare. Your commitment will prove to 

be critical as we move forward to improve quality and safety for patients in the U.S. 

healthcare system.

Healthcare Problems 

As this committee has no doubt learned by now, the U.S. healthcare industry is 

beset with serious problems—especially the 19th century approach of our healthcare 

with respect to technology. Nearly every other major U.S. industry has already 

moved to automate its systems. Try to imagine the banking and finance industry 

without computers. The airline industry is almost completely reliant upon its automated systems. Even your local car dealer has computers to track your service 

record when you go in for a repair. 

Yet the healthcare industry, one of the largest industries in the U.S., continues 

to do business primarily the same way that it has for more than 150 years—with 

paper and pen. We have a saying at Cerner that the pen is the most dangerous 

medical device in healthcare today. 

This Committee is obviously familiar with the December 1999 Institute of Medicine (IOM) study that estimated as many as 98,000 people die each year as a result 

of medical errors. But there are more storm clouds on the horizon for the healthcare 

industry. The graying of the baby boomer generation is about to create an unprecedented stress on our healthcare system—a system that is already overutilized and 

undercapitalized. And the baby boomers are going to peak during a critical workforce shortage. There is also enormous variance in treating patients while redundant and wasteful procedures eat up enormous costs. 

Perhaps just as important, the follow-up March 2001 IOM study states that technology and clinical automation is one of the critical solutions to reduce the number 

of deadly medical errors. The value proposition for using technology in healthcare 

is relatively straightforward—20–40 percent cost reductions, the elimination of most 

medical errors, and the empowerment of consumers to better manage their own 

health. The IOM report tells us ‘‘automation of clinical, financial and administrative 

transactions is essential to improving quality, preventing errors, enhancing consumer confidence in the health system and improving efficiency.’’ The IOM goes on 

to suggest $1 billion as a reasonable starting point to assist the healthcare industry 

in adopting needed technologies. 

I should point out here that we believe $1 billion is a positive first step but that 

it will actually require far more than $1 billion to impact today’s healthcare industry significantly. There is little question that the financial health of the current 

healthcare system will not support the large-scale investments necessary to address 

the current safety problems in healthcare. 

An enormous transformation needs to occur—and quickly. Today’s situation might 

be compared to the critical ‘access’ issues facing this country after World War II. 

At that time, as you may recall, Congress responded by passing the Hospital Survey 

& Construction Act— better known as ‘‘Hill-Burton.’’ It was a massive infrastructure program providing the funding to build many of the nation’s hospitals. But today’s congressional imperative is not to build more facilities. Rather, it’s to help establish a higher-quality, safer health system. A massive congressional effort needs 

to coalesce around funding for technology systems that provide demonstrated return 

on investment (ROI) and elimination of medical errors on a very large scale. 

A Solution 

Given the current state of the economy, however, and the limited resources of 

Congress, it is not realistic to think this enormous investment will take place immediately. Until there is support for a movement to fund a large-scale effort for technology infrastructure in healthcare, Congress should provide incentive funding for 

providers to help with the expense of automating systems that improve quality and 

63

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:

• eliminate the majority of the avoidable medical errors; • reduce the cost of healthcare by 20–40 percent; • reduce the enormous variance that currently exists around how physicians 

diagnose and treat the same medical problem; • empower the consumers to better manage their own health by giving them 

access and control of their own medical records; and • improve workforce retention.

There are several provider systems that have shown value through the use of 

healthcare IT systems. For example:

• A 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-Sa- maritan 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. • Detroit 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. • The 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. • Through 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. • Also 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.

The College of American Pathologists (CAP) is pleased to submit this statement 

Statement of the College of American Pathologists 

f 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 

64

board-certified physicians who practice clinical or anatomic pathology, or both, in 

community hospitals, independent clinical laboratories, academic medical centers 

and federal and state health facilities. The CAP thanks subcommittee Chair Nancy 

Johnson and the subcommittee’s members for their interest in improving health 

care quality and patient safety. 

The CAP is the leading advocate for quality medical testing for patients. The College accredits more than 6,000 laboratories, provides proficiency testing for more 

than 20,000, and offers various other quality improvement programs. Further, the 

College has developed the Systematized Nomenclature of Medicine (SNOMED), the 

world’s most comprehensive international and multilingual clinical reference terminology with broad applications in patient safety and error reduction efforts. 

As you may know, the College, in partnership with the Centers for Medicare and 

Medicaid Services and other agencies, works to ensure Medicare beneficiaries and 

patients nationwide receive quality care in the laboratory. The Clinical Laboratory 

Improvement Amendments of 1988 (CLIA) recognize CAP accreditation as an acceptable substitute for federal laboratory inspections. Also, the College has worked 

closely with the Department of Health and Human Services on cancer screening, 

laboratory standards, genetic testing and other issues. 

CAP Laboratory Accreditation Program (LAP) inspections and Proficiency Testing 

form the foundation of College quality improvement activities. The LAP has long led 

efforts to improve the accuracy and reliability of laboratory testing, thereby reducing 

errors and helping to ensure safer patient outcomes. Dovetailing with LAP is the 

College’s Proficiency Testing program, which allows laboratories worldwide to compare their performance with that of peers and improve outcomes within the laboratory. 

Two other CAP quality improvement programs of particular note are the Cancer 

Protocols and Patient Outcomes Templates. Cancer Protocols, co-developed with clinicians, standardize the evaluation and reporting of cancer specimens and help ensure all relevant information is consistently documented and available to best treat 

cancer patients. Complete pathology reports written in a clear format help protect 

patients from improper treatment by eliminating physician confusion about or misunderstanding of pathologic findings. The College’s Patient Outcomes Templates respond to an emerging need in the marketplace for tools to improve communication 

and foster outcomes quality improvement. Pathologists and clinicians use this program to accurately evaluate and report specific conditions within their institution 

to determine the need for improvement. Both the Cancer Protocols and Patient Outcomes Templates are peer-developed and peer-reviewed, and made available at no 

charge to all CAP members. 

Other College offerings targeted at quality improvement and error reduction include the Q–Probes and Q–Tracks programs, which allow laboratories to assess the 

quality of their clinical and anatomic pathology services by benchmarking their performance against other participating laboratories in the programs. Also of note is 

that several of the Q–Probes programs deal specifically with detecting errors. 

SNOMED 

The College’s concern for quality extends beyond the laboratory walls. Accurate, 

comprehensive and efficient communication among physicians, laboratories, hospitals and other providers is essential to ensuring quality. A common language understood by all health professionals improves the coordination of patient care and 

can reduce the occurrence of medical errors. 

The College’s Systematized Nomenclature of Medicine, or SNOMED, is such a language. SNOMED is the most comprehensive international and multilingual clinical 

reference terminology available in the world. Its unparalleled scope delivers to the 

entire health care community unprecedented uniformity for medical communications 

that spans languages, clinical specialties and geographic borders. 

SNOMED Clinical Terminology, for example, contains approximately 325,000 concepts linked to clinical knowledge to enable accurate recording of data without ambiguity. The terminology’s content also includes more than 800,000 descriptions or 

synonyms relating to clinical concepts, as well as more than 950,000 links, known 

as semantic relationships, between clinical concepts. This structure ensures the 

proper relationships of diseases, treatments, etiologies, clinical findings, therapies, 

procedures and outcomes. 

The possible applications of SNOMED are nearly limitless. The terminology is 

highly flexible, allowing its use by a wide variety of health care enterprises—from 

the individual clinician to major pharmaceutical companies, government agencies 

and nationwide provider organizations. The terminology will help users reduce administrative costs related to the delivery of health care worldwide by supporting the 

electronic patient record. It can be used to standardize surgical records, to code paVerDate Sep 04 2002 01:19 Oct 03, 2002 Jkt 081751 PO 00000 Frm 00068 Fmt 6633 Sfmt 6621 E:\HR\OC\B751.XXX B751
65

tient 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:

• Provides 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. • Allows health care providers to retrieve important information that might 

otherwise be buried among paper records. • Provides better, more complete access to important patient information 

that can be linked to clinical alerts, knowledge databases and health education tools. • Allows 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. • Provides greater clinical specificity to support problem lists, outcomes research, performance measurement and quality improvement. • Shifts 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 bottomline 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 conIntroduction

siders steps to improve the quality of care for all Americans.

Statement of eHealth Initiative 

f 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

66

Driving improvement in the quality, safety, and cost-effectiveness of health care 

through information technology is the mission of the eHealth Initiative (eHI), a nonprofit 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:

• Economic Incentives—eHI promotes economic incentives for better quality care through information technology. • Medical Errors Legislation—eHI advocated for the passage of the 

‘‘Medication Errors Reduction Act of 2001.’’ • Clinical Data Standardization—eHI is focused on driving greater clinical data standardization through the public-private collaboration to improve public health. • Connectivity—eHI is working to increase connectivity between various 

stakeholders in the health care system.

eHI believes that each of the above endeavors is vital because they provide impetus to the proliferation of information technologies and encourage the coordinated, 

real-time health care communications network our Nation needs to address medical 

errors and health care quality issues.

Economic Incentives for Better Quality Care through Information Technology Needed

One of the most important steps that Congress can take to reduce medical errors 

and improve health care quality is to draft and pass legislation that provides economic incentives for better quality care enabled by information technology within 

the health care setting. Information technology has the power to improve the process and price of health care when properly integrated and implemented with 

workflow in clinical and administrative settings. Such technology can: (1) streamline 

the care process; (2) result in better patient health, productivity, and quality of life; 

and (3) reduce health care-related costs. 

It is commonly understood that in the face of increasing reimbursement cuts and 

mounting clinical and administrative responsibilities, health care providers want to 

implement information technology solutions that decrease medical errors, lower 

costs, ease office practice burden, and enhance patient health. Unfortunately, the 

current health care business model does not support broad and effective use of such 

solutions. 

It is problematic that currently, public and private health care incentives and reimbursements are largely based on the traditional doctor or hospital visit model 

where a consultation occurs and information is dispensed during a face-to-face interaction between provider and patient. As medical and information technology evolves, 

new care models which include the use of data from disparate clinical and administrative information systems to support better quality care or from remote interactions will become more prominent. Therefore, economic incentives that fund the 

purchase and adoption of new information technology to handle these functions 

must be implemented. Without these incentives, the purchase of new and enhanced 

information technology tools will be low on the priority list given tightened hospital 

and physician budgets, high administrative costs, and valid competing purchase and 

staffing priorities. 

Many employers, health plans, and hospitals believe that they have squeezed all 

of the possible costs out of the system through the implementation of what many 

saw as the ‘‘answer to the reduction in health care costs’’—managed care. Despite 

those changes, health care costs are continuing to spiral upward. This, combined 

with the aging of the baby-boomers is forcing the health care system to look for new 

answers. Ironically, there is little cashflow left within these organizations to fund 

the very infrastructure that will drive the next wave of much-needed cost reduction 

and improvement in quality—the strategic use of information technology. 

As it has with the building of other infrastructure in the United States over the 

years (such as the hospitals with the Hill-Burton Act and the Interstate Highway 

67

1 U.S. Department of Health and Human Services National Committee on Vital and Health 

Statistics. November 15, 2001. Information for health: a strategy for building the national health 

information infrastructure. 2President’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. 

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. 

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. 

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 

68

and administrative transactions, but also standards for privacy and security. The 

next step, however, lies in the development and broad adoption of clinical transaction standards. 

Through the Foundation for eHealth, the eHealth Initiative is working with the 

Centers for Disease Control and Prevention (CDC), the Centers for Medicare and 

Medicaid Services, several state and local health partners, national standards organizations, and key leaders in the private sector in a public-private collaboration to 

transmit clinical data of public health importance from existing health information 

systems and data sources for public health surveillance purposes, using CDC’s National Electronic Disease Surveillance System (NEDSS), which is a broad initiative 

designed to use national data and information systems standards for the development of efficient, integrated, and interoperable surveillance systems at the state and 

local levels. This initiative represents a critical next step towards accelerating greater data standardization, enhancing information systems interoperability, and facilitating broad adoption of supporting policies and technologies. The power of combining a national need for interoperable systems with data and architectural standards through CDC’s NEDSS with the expertise and leadership of government and 

health care industry leaders, as well as national standards organizations, is extraordinary and will provide the catalyst that is needed to drive greater data standardization, connectivity and compliance with privacy and security policies—all of which 

serve as critical barriers to a national health information infrastructure which is 

greatly needed to drive greater quality health care. 

Conclusion

In conclusion, there are a number of action steps this Subcommittee and Congress 

as a whole, can take to reduce medical errors, and increase cost-effectiveness, quality, and safety within the health care system. First, work must begin to construct 

and pass federally-funded economic incentives for better health care through information technology. Second, comprehensive medical errors legislation such as the 

‘‘Medication Errors Reduction Act of 2001’’ must become law. And lastly, the public 

and private sectors must work collectively to increase data standardization and 

connectivity within and across health care-related institutions, patients, and public 

health agencies. eHI and our members stand ready to lend our voice and privatesector expertise in these endeavors.

The Healthcare Leadership Council (HLC) is a coalition of chief executives of the 

Statement of Mark R. Grealy, Healthcare Leadership Council 

f 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:

69

1. Solutions 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. A 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. Safe 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 broadbased 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. Healthcare 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. Establish a culture of awareness—NOT blame—to drive health care 

errors into the open. Improving patient safety depends heavily on the ability to collect and analyze patient safety data, and to use that information 

to develop safer systems. Laws that perpetuate litigation are antithetical to 

the goal of transforming medical adverse events and ‘‘near misses’’ to permanent and pervasive systems improvements. Lawmakers should carefully consider any new laws or regulations that could actually do damage to the current health care system by making errors and ‘‘near misses’’ even harder to 

identify. Peer review protections should be instituted to protect organizations 

from the fear of litigation which will prevent the sharing of information. 

6. A 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. Focus on prevention instead of errors. Instead of devoting major efforts 

to medical errors after the fact, develop a system focused on studying near 

misses, to prevent adverse events in the first place. This focus should be 

firmly impressed early on in graduate medical education programs as well 

as training programs for all types of health care professionals. 

8. Consider 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: 

• A 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. 

• A litigious health care environment is not conducive to the promotion of 

awareness and information sharing necessary to understand and avoid 

medical errors. 

• A 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 

70

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.

Premier, Inc., an alliance of leading not-for-profit hospitals and health systems, 

Statement of Premier, Inc. 

f 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 

71

1To Err is Human—Building a Safer Health System, Kohn, et al, p. 1, 1999. 

services; the provision of training, educational resources, and clinical and technical 

information; and the fostering of opportunities for networking and collaboration. 

Premier’s on-going medication management clinical performance initiative (CPI), for 

example, integrates new and existing projects to improve patient outcomes by measurably reducing adverse drug events (ADEs) and supporting drug utilization improvements. The aim of this collaborative is to improve patient safety by reducing 

the average number of preventable ADEs at participating hospitals by 50 percent 

by June 2004. 

Premier also champions industry adoption of the Universal Product Number 

(UPN) and accompanying bar code technology for the standard identification and 

tracking of hospital-administered drugs, biologicals and devices, as yet another innovative strategy for improving patient safety. HHS Secretary Tommy Thompson 

echoed this sentiment at a Senate hearing last year, telling lawmakers that ‘‘much 

like grocers use barcodes, caregivers can use UPNs to track and dispense medications and reduce simple human errors.’’ 

Attached to this document, please find the commentary of Premier President and 

CEO Richard Norling, as published in the Feb. 18, 2002 edition of Modern 

Healthcare. It offers additional insight into Premier’s quality and safety improvement philosophy, and details about its initiatives. Again, we appreciate this opportunity to offer a statement for the record on an issue of such paramount importance.

Supporters of HR. 3292, the Medical Error Reduction Act

IBM 

Daimler Chrysler 

Siemens Vanderbilt University Medical Center 

AFL–CIO 

McKesson 

Newt Gingrich 

Aetna 

National Rural Health Association 

Premier 

New York Presbyterian 

Federation of American Hospitals 

Joint Commission on Accreditation of Healthcare Organizations 

VHA Inc. 

eHealth Initiative 

Verizon 

Greater New York Hospital Association 

National Association of Children’s Hospitals 

Florida Hospital Association 

Cerner Corporation 

David W. Bates, M.D. 

BD 

3M 

EDS

Statement of Donald Rucker, M.D., Siemens Medical Solutions Health 

Services Corporation, Malvern, Pennsylvania 

f 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 

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2 Bates D., et.al. JAMA, The Costs of Adverse Drug Events in Hospitalized Patients, 277:307–

311, 1997. 3 Institute of Medicine. Crosssing the Quality Chasm: a new health system for the 21st century. Washington, D.C. National Academy Press, 2001. 4Leapfroggroup.org 

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. 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. 

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. 

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

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. 

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. 

Siemens customers have experienced and measured significant reductions in errors and costs through the use of its clinical information systems. The benefits 

range from clearly quantifiable financial measures to other benefits that have a softer cost relationship.

Reductions in errors 

Danville Regional Health System (Danville, VA) provides an example of how 

medication errors are prevented using bar code scanning and an electronic medication administration record that is integrated into the CPR. Danville presented data 

at the Siemens user group meeting September 9–12, 2001 and during a vendor 

showcase presentation at the American Society of Health-system Pharmacists meeting in December 2001 about their outcomes using Siemens Med Administration 

Check. This system uses bar code scanning at the point of care to help ensure that 

the right patient receives the right drug at the right dose, via the right route, at 

the right time. The system alerts nurses whenever a drug is past due, or that the 

nurse is attempting to administer a drug that does not match the order, or that the 

patient is not the intended patient. The hospital has been preventing on average 

12 errors per month. Mary Washington Hospital, part of Medicorp (Fredericksburg, 

VA) also presented data at the September and December meetings. They indicated, 

using their language, that they were making on average 71 saves per week with 

the system. They defined a save as any of the following activities; scanning the 

wrong drug or patient, a drug that was scanned too early, or when nursing used 

the send message function to alert pharmacy to a problem with either the order or 

the drugs delivered. This averaged out to be 22 wrong medications scanned, 13 

drugs scanned early, and 30 messages sent to pharmacy per week. 

When looking at medication errors, transcription errors are accountable for 11%–

12% of the mishaps.6 The Ohio State University Health System has documented 

that using computerized physician order entry they have eliminated transcription 

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7Mekhjian 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? 9Mekhjian HS, et. al. Immediate benefits realized following the implementation of physician 

order entry at an academic medical center. JAMIA (In Publication for 2002) 

errors.7 With 100% of all orders being entered into the computer system directly by 

physicians, there is no more illegible handwriting for nurses and clerks to decipher. 

Kingsbrook Jewish Medical Center in Brooklyn New York is another facility that 

has 100% of all orders placed directly by physicians into the computerized physician 

order entry system. Kingsbrook has also eliminated all verbal orders and telephone 

orders.8

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 

74

10Skarulis P, Brill J., Lehman M. HIMSS 2002 Session 126 Rush Physician Order Entry: 

From Physician Resistors to Physician Champions. 11Mekhjian HS, et. al. 12Mekhjian HS, et. al. 13 Eisenberg, F., Krusch, D., Meindel, N., HIMSS 2002 Session 127 Can Physician Order 

Entry and Physician Alignment / Satisfaction Coexist? 14Skarulis P, Brill J., Lehman M HIMSS 2002 Session 126 Rush Physician Order Entry: 

From Physician Resistors to Physician Champions. 15Skarulis 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

order cycle time of 3:49 hours and post-CPOE time of 1:23 hours.10 This is a 64% 

reduction. 

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. 

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

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. 

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

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 

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17Skarulis P, Brill J., Lehman M HIMSS 2002 Session 126 Rush Physician Order Entry: 

From Physician Resistors to Physician Champions. 18Skarulis P, Brill J., Lehman M HIMSS 2002 Session 126 Rush Physician Order Entry: 

From Physician Resistors to Physician Champions 19Meindel N. User Summit 2001, Washington DC

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

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. 

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. 

Conclusion 

Again, we appreciate the opportunity to submit testimony on this important topic. 

Expanding hospitals’ use of use of computerized patient records will further help to 

improve the quality of care and reduce errors. Siemens customers have been able 

to show that these systems meet the objectives of improving efficiency, effectiveness, 

and safety. Further gains will be achieved as care models move to evidence-based 

best care practices. The computer-based patient record helps to facilitate these process changes. Technologies such as computerized physician order entry, point-of-care 

bar code scanning for medication quality checking, and clinical decision support systems enable clinicians to concentrate on making the right decisions instead of 

searching for the right information. 

Attachment 1 Summary of Siemens Customer Realized Computerized Physician Order Entry Benefits 

POE Outcome Siemens Solution Proven Outcomes 

Reduction in Turn 

Around Time 

• Electronic transmission of orders to 

departments. 

• Orders complete 

when written 

• Process standardization 

• Improved access to 

patient information 

The Ohio State University Health System 

25% reduction in Lab order cycle time 

43% reduction in Radiology cycle time 

64% reduction in medication cycle time 

Rush Presbyterian St. Lukes 

64% reduction in medication cycle time 

Meridian Health System 

84% reduction in medication cycle time

Reduction in Cost Reduction of variance in care • Order sets 

• Process standardization 

The Ohio State University Health System 

7.5% to 8% reductions for several services 

Rush Presbyterian St. Lukes 

Reduction in multi-part forms 

Elimination of Unit Clerks

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Attachment 1 Summary of Siemens Customer Realized Computerized Physician Order Entry Benefits—

Continued

POE Outcome Siemens Solution Proven Outcomes 

Reduction in Length of 

Stay 

• Order sets 

• Process standardization 

The Ohio State University Health System 

1.9% to 5.1% reduction in length of 

stay

Increase compliance with 

best practice protocols 

• Alerts and reminders Rush Presbyterian St. Lukes 

Increase compliance with blood culture 

order procedure up from 39.8% to 

57%. (Physicians using paper at 

same time did not change)

Reduction in errors • Forcing functions 

• Ability to enforce policy through log-ons 

The Ohio State University Health System 

100% elimination of transcription errors 

50% reduction of medication errors 

Kingsbrook Jewish Medical Center 

100% eliminated verbal and telephone 

orders

Improve documentation 

compliance 

• Forcing functions 

within workflow 

The Ohio State University Health System 

Verbal order cosignature compliance 

rate up from 72.8% to 98.95% 

Rush Presbyterian St. Lukes 

100% of orders entered directly by physician are dated, timed, signed, and 

legible

Reduce insurance claims 

rejections 

• Provide alerts 

• Drop down selections 

make it easy to complete documentation. 

Rush Presbyterian St. Lukes 

Radilogy order reason, made it easier 

to provide an accurate exam reason, 

instead of ‘‘rule/out’’, the rate of stated reasons of ‘‘rule/out’’ dropped from 

30% of all radiology orders to only 

8%.

Speed patient notification of recalls • Search and report 

against enterprise patient list 

Kingsbrook Jewish Medical Center 

Within hours of FDA recall notice, 

searched 800 active patients and discontinued affected drug.

Reduced use of overused 

antibiotics 

• Online clinical alerts Rush Presbyterian St. Lukes 

Imipenem resistance dropped from 50% 

to 15%

Resource re-allocation The Ohio State University Health System 

FTE directed to chart reviews per-POE 

was promoted to a coder 

Rush Presbyterian St. Lukes 

Eliminated unit clerk positions 

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