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86–199 2003

LEGISLATION TO REDUCE MEDICAL ERRORS

HEARING

BEFORE THE

SUBCOMMITTEE ON HEALTH

OF THE

COMMITTEE ON WAYS AND MEANS 

HOUSE OF REPRESENTATIVES

ONE HUNDRED SEVENTH CONGRESS

SECOND SESSION

SEPTEMBER 10, 2002

Serial No. 107–95

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

Advisories announcing the hearing ........................................................................ 2, 4

WITNESSES 

U.S. Department of Health and Human Services, Hon. Tommy G. Thompson, 

Secretary, accompanied by Carolyn Clancy, Acting Director, Agency for 

Healthcare Research Quality .............................................................................. 9

Healthcare Leadership Council, and Mayo Foundation, Michael B. Wood, 

M.D. ....................................................................................................................... 33

Leape, Lucian L., M.D., Harvard School of Public Health, Harvard University 29

National Academy for State Health Policy, Jill Rosenthal .................................. 48

New York-Presbyterian Health Care System, Herbert Pardes, M.D. ................. 42

Pittsburgh Regional Healthcare Initiative, Kenneth T. Segel ............................. 38

SUBMISSIONS FOR THE RECORD 

U.S. Department of the Treasury, Hon. Paul O’Neill, Secretary, statement ...... 9

American Academy of Family Physicians, statement ........................................... 70

American College of Obstetricians and Gynecologists, statement ....................... 71

American College of Physicians-American Society of Internal Medicine, statement ...................................................................................................................... 72

American Medical Association, statement ............................................................. 73

American Medical Group Association, Alexandria, VA, Donald W. Fisher, 

letter and attachment .......................................................................................... 75

American Nurses Association, statement .............................................................. 77

Biomedical Metatechnology Inc., Amherst, NY, Irwin D. Bross, letter ............... 79

Bonner, Dena J., Los Angeles, CA, letter .............................................................. 80

Carlson, Richard E., M.D., Centennial, CO, letter ............................................... 82

Coyne, Hon. William J., a Representative in Congress from the State of 

Pennsylvania ........................................................................................................ 26

ECRI, Plymouth Meeting, PA, Jeffrey C. Lerner, letter ...................................... 82

Society of Thoracic Surgeons, statement ............................................................... 83

(1)

LEGISLATION TO REDUCE MEDICAL ERRORS 

TUESDAY, SEPTEMBER 10, 2002

HOUSE OF REPRESENTATIVES, 

COMMITTEE ON WAYS AND MEANS, 

SUBCOMMITTEE ON HEALTH, 

Washington, DC.

The Subcommittee met, pursuant to notice, at 11:48 a.m., in 

room B–318, Rayburn House Office Building, Hon. Nancy L. Johnson (Chairman of the Subcommittee) presiding. 

[The advisory and the revised advisory announcing the hearing 

follow:]

2

ADVISORY

FROM THE COMMITTEE ON WAYS AND MEANS

SUBCOMMITTEE ON HEALTH

FOR IMMEDIATE RELEASE CONTACT: (202) 225–3943

September 3, 2002

No. HL–17

Johnson Announces Hearing on

Legislation to Reduce 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 legislation to reduce medical errors. The hearing will take 

place on Tuesday, September 10, 2002, in the main Committee hearing 

room, 1100 Longworth House Office Building, beginning at 10:00 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 academic experts 

and representatives from professional organizations. 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: 

H.R. 4889, the ‘‘Patient Safety Improvement Act of 2002,’’ was introduced by 

Chairman Johnson on June 6, 2002. The bill seeks to reduce medical errors by encouraging reporting of adverse events to new patient safety organizations. These 

new organizations would analyze what went wrong and provide feedback to health 

providers so that they can learn from their mistakes. This hearing builds on the testimony provided at the Subcommittee’s March 7, 2002, hearing on medical errors. 

Medical errors permeate our health system. More than three years ago, the Institute of Medicine (IOM) reported that preventable medical errors are the eighth leading cause of death in America—ahead of breast cancer, AIDS and traffic deaths. 

Nearly 100,000 patients die in hospitals each year as a result of preventable mistakes. The number of injured is even greater. And yet in the three years since the 

release of the breakthrough IOM report, no legislation has passed either chamber 

of Congress. 

In announcing the hearing, Chairman Johnson stated, ‘‘We have spent too much 

time discussing the potential for quality improvement and fewer errors in health 

care. It is clear that Federal leadership can make a difference and Congress can 

make that happen. I am looking forward to thoughtful input and a lively discussion 

to help us in our consideration of this bill.’’

FOCUS OF THE HEARING: 

Tuesday’s hearing will focus on the draft Chairman’s mark of H.R. 4889. 

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 hearingclerks.waysandmeans@mail.house.gov, along with a 

fax copy to (202) 225–2610, by the close of business, Thursday, September 12, 2002. 

3

Those filing written statements who wish to have their statements distributed to 

the press and interested public at the hearing should deliver their 200 copies to the 

Subcommittee on Health in room 1136 Longworth House Office Building, in an open 

and searchable package 48 hours before the hearing. The U.S. Capitol Police will 

refuse sealed-packaged 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 hearingclerks.waysandmeans@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. Any statements must include a list of all clients, persons, or organizations on whose behalf 

the witness appears. A supplemental sheet must accompany each statement listing the name, 

company, address, telephone and fax numbers of each witness. 

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.

f

4

* * * NOTICE—CHANGE IN TIME * * *

ADVISORY

FROM THE COMMITTEE ON WAYS AND MEANS

SUBCOMMITTEE ON HEALTH

FOR IMMEDIATE RELEASE CONTACT: (202) 225–3943

September 6, 2002

No. HL–17–Revised

Johnson Announces Hearing on

Change in Time for Subcommittee Hearing

on Legislation to Reduce Medical Errors

Congresswoman Nancy L. Johnson (R–CT), Chairman, Subcommittee on Health 

of the Committee on Ways and Means, today announced that the Subcommittee 

hearing on legislation to reduce medical errors, scheduled for Tuesday, September 

10, 2002, at 10:00 a.m., in the main Committee hearing room, 1100 Longworth 

House Office Building, will now be held at 11:00 a.m.

All other details for the hearing remain the same. (See Subcommittee Advisory 

No.

Stark is on his way back from the Floor and I thought I would get 

Chairman JOHNSON. The Committee will come to order. Mr. 

HL–17, dated September 3, 2002.)

f us moving. My apologies, Mr. Secretary, for the long delay. These 

things are beyond our control. 

I want to remind the Committee that it was more than 3 years 

ago that the Institute of Medicine (IOM) reported that preventable 

medical errors are the eighth leading cause of death in America. 

These are ahead of breast cancer, AIDS, and traffic deaths. Yet no 

legislation has been approved by any Committee in either chamber 

of Congress to deal with this crisis. Nearly 100,000 patients die in 

hospitals each year as a result of preventable mistakes, and the 

number of injured is far greater. Clearly, it is time to act. 

The draft Chairman’s mark, which is before the Committee at 

this time, extends confidentiality protection and privilege standards to patient safety data that is reported externally to new Patient Safety Organizations (PSO). These certified and independent 

organizations will analyze the reports from health care providers 

and provide feedback on what went wrong and how to fix it. Reporting adverse events and close calls allows us to gain insight into 

how to prevent errors. By protecting reporters, we will stimulate a 

rich process that should enable providers to dramatically improve 

the quality of health care. 

The bill also establishes a new Center for Patient Safety within 

U.S. Department of Health and Human Services (HHS) to be the 

focal point of Administration policy on patient safety. This center 

will administer a new medical errors database of non-identifiable 

information. Researchers will use this database to identify national 

5

trends and encourage best practices to prevent errors and improve 

health care quality. 

Finally, the bill establishes a process through which new voluntary standards for interoperability can be developed. In our 

quest for improved health care quality, the urgency for investing in 

health care information technology is exceeded only by that for investment in patient safety systems. The health care industry has 

lagged far behind other sectors of our economy in adopting the information systems that can assure continuous quality improvement. 

Consequently, we must not only shield the reporting of health 

care delivery problems from legal liability. We must also support 

the development of the infrastructure needed to gather data, analyze data, problem solve, and disseminate recommendations for 

quality improvement. Therefore, the bill establishes a new Technology Advisory Board to provide expert advice to the Secretary in 

creating interoperability standards. We simply cannot afford to establish broad information systems that do not talk to each other. 

Patient safety is too important. 

That is what H.R. 4889 is designed to do. H.R. 4889 would facilitate the identification of health care delivery problems through voluntary and confidential reporting. It supports the analysis of data 

and development of recommended best practices. The bill also provides for the dissemination of recommendations for best practices 

back to the health care industry. All of these activities would be 

privileged or shielded from discovery for litigation purposes. Fear 

of legal liability has had a chilling effect on the development of reporting and analysis of errors data that can save lives and create 

a health care delivery system capable of continuous quality improvement. 

This legislation incorporates the recommendations of experts, 

consumers, policy makers, and my colleagues in Congress. The 

overwhelming and positive response to our proposal is a testament 

to the broad recognition in the industry that much more can be 

done. I am pleased that 50 provider, patient, quality improvement, 

and national accreditation organizations have endorsed this draft 

proposal. 

Secretary Thompson, you need no introduction to this Committee. I am very pleased that you have worked closely with us, as 

has Centers for Medicare and Medicaid Services (CMS), the Agency 

for Healthcare Research Quality (AHRQ), and the U.S. Department 

of the Treasury and the White House, in developing this draft. I 

am also very pleased that your testimony will review the great variety of initiatives that you have led to achieve these very same 

goals of improved patient safety and improved health care quality. 

Our second panel is also impressive. Dr. Lucian Leape from Harvard University is a member of the IOM’s Committee on Quality 

of Health Care in America and one of the authors of the 1999 report on errors. 

Dr. Michael Wood is President and Chief Executive Officer of the 

Mayo Foundation and is testifying on behalf of the Health Leadership Council. Also joining us is Ken Segel, Director of the Pittsburgh Regional Healthcare Initiative, whose organization testified 

at our initial hearing. Dr. Herbert Pardes is the President and 

6

Chief Executive Officer of the New York-Presbyterian Health Care 

System. He brings a wealth of expertise on information technology 

and computerized medical records. Jill Rosenthal is a project manager at the National Academy for State Health Policy who will give 

us a perspective from the State’s point of view and experience. 

[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 

More than three years ago, the Institute of Medicine (IOM) reported that preventable medical errors are the eighth leading cause of death in America—ahead of 

breast cancer, AIDS, and traffic deaths. And yet, no legislation has been approved 

by any committee or either chamber of Congress to deal with this crisis. Nearly 

100,000 patients die in hospitals each year as a result of preventable mistakes. The 

number of injured is far greater. 

Just yesterday, newspapers reported on findings by researchers at Auburn University who analyzed data from 36 hospitals and nursing homes in Colorado and 

Georgia of an 81-day period in 1999. These researchers found medication errors in 

about 20% of the doses administered in a ‘‘typical’’ 300-bed facility, and found 7% 

of the errors ‘‘potentially harmful.’’ Not only do medical errors harm and take the 

lives of innocent, often basically healthy patients, they are costly. 

According to the Pittsburgh Healthcare Initiative, medication errors result in $3,500 to $4,000 additional costs per incident, an unacceptable financial cost borne 

by hospitals, individuals, public health programs and, yes, Medicare. 

The evidence of the human and economic costs of errors is simply overwhelming! 

It’s simply time we must act. On March 7 of this year, the Subcommittee held a 

hearing on this issue, with testimony from some of the country’s most highly recognized experts on reducing medical errors. At that hearing, Mr. Stark stated that he 

hoped our next meeting on this would be a markup. And while we began work immediately, fear developed that any product developed could be used to make the prescription drug bill ‘‘bipartisan.’’ Despite assurances, that concern lingered and we 

laid aside our work on this topic until the prescription drug bill passed the House. 

Since that time I introduced a base bill on June 6 that was developed with experts’ 

and Member input and then continued to explore aspects of this issue with my colleagues Mrs. Thurman, and Messrs. Houghton, Cardin and Stark that resulted in 

a new draft Chairman’s mark in July. 

On August 2, I solicited comments from all members of the IOM Committee that 

produced the medical errors report. I am pleased that we received near-unanimous 

support for this new proposal, as well as suggestions for refinements and changes. 

From this hearing we will propose a final draft for consideration by the full Committee in the near future. 

The draft Chairman’s mark extends confidentiality protection and privilege standards to patient safety data that are reported externally to new Patient Safety Organizations. These certified and independent organizations will analyze the reports 

from health care providers and provide feedback on what went wrong and how to 

fix it. Reporting adverse events and close calls allows us to gain insight into how 

to prevent errors. By protecting reporters we will stimulate a rich process that 

should enable providers to improve dramatically the quality of care. 

The bill also establishes a new Center for Patient Safety within HHS to be the 

focal point of Administration policy on patient safety. This center will administer 

a new medical errors database of non-identifiable information that researchers will 

use to identify national trends and encourage best practices to prevent errors and 

improve health care quality. 

Finally, the bill establishes a process through which new, voluntary standards for 

interoperability can be developed. 

In our quest for improved health care quality, the urgency for investing in health 

care information technology is exceeded only by that for investment in patient safety 

systems. The health care industry has lagged far behind other sectors of our economy in adopting the information systems that can assure continuous quality improvement. 

Consequently, we must not only shield the reporting of health care delivery problems from legal liability, but also support the development of the infrastructure 

needed to gather data, analyze them, problem solve, and disseminate recommendations for quality improvement. Therefore, the bill establishes a new technology advisory board to provide expert advice to the Secretary in creating these interoperVerDate jul 14 2003 07:07 Sep 04, 2003 Jkt 086199 PO 00000 Frm 00010 Fmt 6633 Sfmt 6621 E:\HR\OC\86199A.XXX 86199A
7

ability standards. We simply cannot afford to establish different brand information 

systems that do not talk to each other. Patient safety is too important! 

That is what H.R. 4889 is designed to do. H.R. 4889 would facilitate the identification of health care delivery problems through voluntary and confidential reporting. It supports the analysis of data and development of recommended best practices. And it provides for the dissemination of recommendations for best practices 

back to the health care industry. All of these activities would be privileged—or 

shielded from discovery for litigation purposes—because it has been the fear of legal 

liability that has had such a chilling effect on the development of the reporting and 

analysis of errors data that can save lives and create a health care delivery system 

capable of continuous quality improvement. 

Throughout, we also recognize the need for establishing information systems that 

communicate with each other to support clinical decision making as well as quality 

improvement activities. We were told by many experts that national leadership is 

needed to speed the adoption of technology standards for health care information 

systems. This bill establishes an advisory board and process for the development of 

national information technology standards and will assure the development of interoperable systems in the competitive market with tremendous benefits for quality improvement in health care. 

This legislation incorporates the recommendations of experts, consumers, policymakers, and my colleagues in Congress. The overwhelming and positive response to 

our proposal is testimony to the broad recognition in the industry that much more 

can be done, and that the will is there to make it happen. I’m pleased that 50 provider, patient, quality improvement, and national accreditation organizations have 

endorsed this Chairman’s draft. 

Of course, Secretary Thompson needs no introduction to this Subcommittee. In 

working with you and officials from CMS, the Agency for Healthcare Research and 

Quality, the Department of the Treasury and the White House, we believe we have 

shaped a good legislative product the Administration can endorse. Mr. Secretary, I 

welcome you here today. 

Our second panel is impressive. Dr. Lucian Leape from Harvard University is a 

member of the IOM’s Committee on Quality of Health Care in America and an author of the 1999 report on errors. Dr. Michael Wood is the President and CEO of 

the Mayo Foundation and is testifying on behalf of the Healthcare Leadership Council. 

Also joining us is Ken Segal, Director of the Pittsburgh Regional Healthcare Initiative, and whose organization testified at our last hearing. Dr. Herbert Pardes is 

the President of New York-Presbyterian and CEO of the New York-Presbyterian 

Healthcare System. He brings a wealth of expertise on information technology and 

computerized medical records. 

Lastly, Jill Rosenthal is a Project Manager at the National Academy for State 

Health Policy who will give us a perspective from the states. 

my colleague, Mr. Stark. 

Welcome, Secretary Thompson. We look forward to your testimony.

Before I recognize Secretary Thompson, I would like to recognize 

f Mr. STARK. Thank you, Madam Chair, and thank you for holding these hearings. There are, indeed, some differences out in the 

land of patient protection and my hope is that those can be reconciled. 

I would quote here from an article from Medscape, Money, and 

Medicine, and it says that the approaches formed by IOM report 

were the basis of recommendations unveiled several years ago. This 

is an article in the year 2000. It says, ‘‘However, groups are sharply split over whether health care organizations should be mandated 

to report serious or sentinel medical events to State agencies. Such 

information would be grouped together and submitted to a Federal 

agency, which would report the data to the public while maintaining the confidentiality of the patients and health care professionals 

involved. Data reported to a Federal entity would be analyzed to 

8

determine why the error occurred and how to reduce or eliminate 

the likelihood that such an event would be repeated.’’

Then in March of 2000, there was an editorial in, interestingly 

enough, the British Medical Journal, but it was co-authored by one 

of our witnesses today, speaking to the issue of medical errors, and 

I quote from the editorial. It says, ‘‘If we can mobilize our resources 

and make safety our priority, health care can make tremendous 

strides in the next few years. Today’s culture of blame and guilt 

too often shackles us. Achieving the culture we need, one of learning, trust, curiosity, systems thinking, and executive responsibility, 

will be immensely difficult. Harder still, we must now accomplish 

this cultural change under the spotlight of a newly aroused public 

that, given our track record,’’ referring to the medical and hospital 

profession, ‘‘it is understandably doubtful that health care can on 

its own do what needs to be done.’’

‘‘Indeed, the public’s doubt in our commitment may be all too 

well founded. In truth, no other hazardous industry has achieved 

safety without substantial external pressure.’’ I would like to repeat that. ‘‘No other hazardous industry has achieved safety without substantial external pressure. Three decades of accumulating 

evidence of medical errors offers plenty of ammunition to those who 

claim that we may need to be forced to do what is at bottom right.’’

‘‘The need is obvious and the mandate is clear. Will we respond 

adequately and fast enough? Will hospitals and health care organizations get serious enough soon enough about patient safety? Will 

they make the changes that are needed, and will they be willing 

to hold themselves accountable for achieving improvements? Can 

we accept the legitimacy of the public’s right to know when serious 

accidents occur and can we honor the public’s legitimate expectation that we will admit our mistakes, investigate, and make 

changes necessary to prevent them in the future?’’

‘‘As we enter this new century, a key lesson from the old is that 

everyone benefits from transparency. Both the safety of our patients and the satisfaction of our workers require an open and nonpunitive environment where information is freely shared and responsibility is broadly accepted.’’

I am afraid, Madam Chair, that by ignoring the mandatory portion of the IOM’s recommendations for medical procedures that 

cause death or major harm, we are dancing this jig on one leg and 

that the bill may need some serious adjustment, but we will hear 

from witnesses about that as we proceed and maybe we can help 

the process through the enlightenment of these hearings. Thank 

you. 

Chairman JOHNSON. Thank you very much, Mr. Stark. I would 

like to recognize Chairman Thomas. I am delighted he has joined 

us for this important hearing, part of it, at least. 

Chairman THOMAS. Thank you very much, Madam Chairman. 

Thank you, Mr. Secretary, for being with us. Knowing that there 

has been some bipartisan movement on this, I would just react partially to the Ranking Member, the gentleman from California. I 

know one sure recipe for disaster, and that is to continue to ignore 

in any legislative form trying to move forward. I know that there 

are multiple Committee jurisdictions. There are different ways to 

9

do this. Perhaps this will need some additional examination as we 

move forward, as most legislation does. 

I want to compliment the Chair and this Subcommittee for beginning the process. It maybe is several years later than it should 

have begun, but it is beginning. I also know that there will be significant changes, hopefully, in the industry as they become more 

systematic and look at models that actually work and we may have 

to adjust the legislation to the realities of the changing work environment to produce a reduction of errors in the workplace, especially hospitals and other areas outside of hospitals. I understand 

there is going to be a cost, a new way of doing things. 

Given the information we know we have, a non-reaction is completely unacceptable. So, I want to underscore the fact that you 

need to begin to finish and I believe we have begun the process, 

certainly not too early, and we are open to any reasonable, rational, 

and appropriate changes, as we always are, in driving toward the 

end product, which is reducing medical errors and improving patient safety. 

I want to underscore the fact that the Secretary was kind enough 

to come, especially at a Subcommittee level, to give this a bit more 

impetus, because I believe although he may not agree the product 

is perfect the way it is and will have some suggestions as well, beginning the process is all important. I want to thank the Chairman 

for doing that, and thank you for allowing me to say a word. Thank 

you very much, Mr. Chairman. 

Mr. Secretary, it is a pleasure to have you. My apologies that the 

business of the House on the Floor delayed the beginning of this 

hearing. Welcome. 

STATEMENT OF HON. TOMMY G. THOMPSON, SECRETARY, U.S. 

DEPARTMENT OF HEALTH AND HUMAN SERVICES, ACCOMPANIED BY CAROLYN CLANCY, ACTING DIRECTOR, AGENCY 

FOR HEALTHCARE RESEARCH AND QUALITY 

Secretary THOMPSON. Thank you very much, Madam Chairwoman, and thank you so very much for holding this hearing, and 

the Ranking Member, Congressman Stark, and Chairman Thomas, 

and all Members of the Committee, it is a pleasure to be here. 

Madam Chairperson, I would like to ask your permission to introduce for the record a statement from Secretary Paul O’Neill of the 

U.S. Department of the Treasury who has asked me to submit it, 

and I will. I would also like to introduce Carolyn Clancy, who is 

the head of AHRQ, who is going to be able to stay on after I leave 

in order to answer any questions, if there are still questions after 

I leave. 

Chairman JOHNSON. Thank you. We will submit that statement. 

[The statement of Secretary O’Neill follows:]

Statement of the Hon. Paul O’Neill, Secretary, U.S. Department of the 

Treasury

PATIENT SAFETY IMPROVEMENT ACT 

Today at least 100,000 Americans every year die because of medical errors and 

mistakes, despite the best efforts of the good doctors, nurses and hospitals in this 

country. The system they work in is broken. Everybody knows a story about a friend 

10

or relative who went into the hospital and had something go wrong. We can and 

must change that. We’ve tinkered long enough with our health care system—a 

band-aid here, a cosmetic fix there. Mistakes and errors don’t just cost money, they 

cost lives. 

I spent considerable time working to reform the health care delivery system in 

Pittsburgh, where I saw firsthand that it is possible to make systematic and farreaching improvements in health care quality and safety. Every American deserves 

this kind of high-quality, error free health care. 

We know from other high risk industries, such as aviation, that a fundamental 

requirement for improvement is that it must be safe to learn from errors. Punishment, ridicule and legal exposure drive error reporting underground so corrective action does not occur. Properly constructed health care quality and safety initiatives 

should be protected from liability. They are not now. 

Along with Secretary Thompson, our leader on national health care policy, I applaud the sponsors of the Patient Safety Improvement Act for tearing down the barriers to quality improvement so that we can move toward the goal of error-free 

health care for every American.

Madam Chairwoman. It is always good to see you, Madam ChairSecretary THOMPSON. Members of the Subcommittee and 

f woman, and to thank you for your ongoing commitment and your 

passion and compassion to quality health care for all Americans. I 

am proud to be your partner in that effort. 

I am honored to appear before this very important Subcommittee 

today to discuss ways that the Federal Government can help reduce medical errors and improve the safety of the health care services that Americans receive. 

I first testified before Congress about this issue early in my tenure as Secretary of Health and Human Services. Reducing medical 

errors, and doing so dramatically, is a priority for this administration. 

In the last few years, the Department of Health and Human 

Services has developed a coordinated set of initiatives to identify 

and to reduce threats to patient safety and improve the quality of 

patient care. Yet, while these initiatives are important, they are, 

as the Chairman has already indicated, only a beginning. 

As we all know, the Institute of Medicine’s landmark 1999 report, ‘‘To Err Is Human,’’ alerted the Nation to the patient safety 

challenge in ways that prior studies had not. The IOM estimated 

that up to 98,000 Americans die each year as a result of medical 

errors, making such errors the eighth leading cause of death in the 

United States, as you indicated, Madam Chairwoman. More people 

die from medical errors than from automobile accidents, breast cancer, or AIDS. While there has been subsequent debate about the actual number of deaths, the precise number is less significant than 

the indisputable fact that the rate of medical errors is unacceptably 

high. 

So, for the sake of public health, much more can and must be 

done to eliminate the barriers that discourage health care providers from participating voluntarily and enthusiastically in local 

and regional patient safety and quality improvement efforts. Yet 

the main barrier is that professionals fear that if they report some 

event or some condition that is less than perfect, the report will be 

used to generate litigation, not redress or correct the problem. 

The savings generated by national malpractice litigation reform 

would help us provide a prescription drug benefit for seniors and 

11

help the uninsured obtain insurance. We in the Bush Administration are doing all we can to take those steps, and we will not stop 

until the job is done. 

One of the steps we must take is addressing your legislation, 

Madam Chairwoman. Without question, health care providers need 

assurances that if they report errors, the information will be used 

constructively, not as evidence in a trial. The President made this 

point explicit in his speech in my great home State medical college 

in Wisconsin when he said, and I quote, ‘‘We actually have a system that penalizes doctors for trying to prevent errors and avoid 

complications in patient care, because when they discuss information about patient care, they put themselves or others at a risk of 

a lawsuit.’’

I am very pleased to say that the legislation this Committee is 

considering, legislation that you have authored, Madam Chairwoman, for which I thank you very deeply, represents an essential 

change in direction, taking us away from the blame game after 

there has been an injury and setting us on the more productive 

path of improving the system and preventing adverse events from 

occurring in the first place. It will do so by encouraging a culture 

of learning and constant quality improvement in our health care 

system. 

Of course, the vast majority of doctors, nurses, and other health 

care professionals are dedicated, conscientious people who work 

long hours under very difficult circumstances, and, in fact, health 

professionals are not opposed to quality improvement. Just the opposite, and you are going to hear about that this afternoon. They 

embrace it. As they have told all of us, it must be real, and it must 

be meaningful quality improvement done in a supportive and in a 

cooperative way. The legislation in this Committee meets these important principles, and I thank you. 

Madam Chairwoman, your legislation provides the types of protections that the President believes are essential to foster the development and the institutionalization of quality improvement efforts in our health care system. I commend you and your colleagues 

for your leadership in developing and, we hope, enacting this very 

important legislation. 

The proposal assures doctors and other health professionals that 

if they report information to expert Patient Safety Organizations, 

the information will be used for patient quality improvement efforts and will be kept confidential. This will encourage them to report and will greatly increase the amount of data available for 

analysis by the experts. Because they will receive information from 

more than one hospital and about more than one doctor, they will 

be able to detect patterns of good and bad practices that might not 

otherwise be noticeable on a single provider basis. They will be 

able to provide recommendations to local providers about system 

changes that the providers would not have been able to develop on 

their own. These new Patient Safety Organizations will promote 

collaboration and cooperation among providers on a regional basis. 

They will be proactive. 

The legislation recognizes that the new ways of addressing quality are needed. It focuses on system improvements, not attacks on 

the providers. It will make it easier to bring information about how 

12

the system works, rather than one provider, one doctor, or even one 

hospital. It will be able to gather information from a broad range 

of providers and see how the system works and how to improve it. 

Let me share with you one example of how detection of medical 

errors and sharing of information can bring significant changes 

when errors become much too extensive. Anesthesiologists have 

dramatically reduced the patient death rate from anesthesia administered during surgery, from 2 deaths per 10,000 anesthetics in 

the mid-eighties to, today, about 1 death for every 200,000 to 

300,000 anesthetics administered today. How did they do it? 

First, they acknowledged that a problem existed in the way the 

equipment was being used. They shared that information, and it 

changed the way anesthesiology was practiced. They standardized 

anesthesia machines to ensure consistency in the delivery of the 

drugs and also addressed issues of fatigue and sleep deprivation, 

changes in training, and competing institutional priorities. 

Anesthesiologists have shown us what can be done by using the 

example in your legislation, Madam Chairwoman. It is a combination of technology, work processes, human factors, institutional culture, and the working environment. 

The bill is forward-looking and proactive. The Patient Safety Organizations will be able to examine processes and look at outcomes 

at various institutions and make suggestions for improvements. 

The measure recognizes the value of local and private quality efforts. Doctors and hospitals will be able to work together with local 

Patient Safety Organizations to identify problems and experiment 

with different ways of improving care. 

Madam Chairwoman, your bill also complements existing HHS 

patient safety activities and, in turn, will help us to guide our ongoing technical assistance to private sector initiatives in the Patient Safety Organizations. Included in these efforts is our Patient 

Safety Task Force, which brings together the Centers for Disease 

Control and Prevention, the Centers for Medicare and Medicaid 

Services, and the Food and Drug Administration (FDA), along with 

our lead research agency on patient safety, the Agency for 

Healthcare Research and Quality. 

One of our initiatives which has been undertaken by the FDA includes our partnering with the private sector to develop new technologies, such as bar coding medications. That will produce electronic prescription programs that can be introduced widely and 

help diminish the number of medication errors. Bar coding is so 

simple. Grocery stores use it all the time. We are funding now the 

research to apply bar coding technology to the way that patient information is stored and reviewed and the way medications are dispensed. This is going to save money, and much more importantly, 

is going to save lives. 

In total, the FDA is receiving $5 million in new funding for patient safety, bringing its total funding for this issue to $22 million. 

The new funds will allow the agency to improve its ability to assess 

and follow up on reports of adverse events that occur after the use 

of FDA-regulated products. 

An important goal of the Task Force is to simplify the reporting 

of patient safety data to our agencies. The current system is unnecessarily burdensome. The same adverse event often needs to be reVerDate jul 14 2003 07:07 Sep 04, 2003 Jkt 086199 PO 00000 Frm 00016 Fmt 6633 Sfmt 6602 E:\HR\OC\86199A.XXX 86199A
13

ported in different ways, on separate forms, to different HHS components, and those who report the data never learn whether it is 

useful. The Patient Safety Task Force will replace this cumbersome 

system, providing a new streamlined system that uses new technologies to help collect and analyze incoming data. 

Our funding request also reflects our personal commitment. Included in AHRQ’s fiscal year 2003 budget submission is a request 

for $2 million to launch a Patient Safety Improvement Corps, experts now who will work with State health departments and health 

care institutions to expand State and local capacity to use existing 

knowledge to identify and eliminate threats to patient safety. 

So, Madam Chairwoman, I look forward to working with you and 

all the Members on this Subcommittee on this legislation because 

it is not some matter of arcane public policy or some set of rules 

only an actuary could love. It is about saving lives, nothing more, 

nothing less, and that is worth our time, our energy, and our commitment. 

I would be more than happy to answer any questions that you 

or Members of the Subcommittee might have, and I thank you very 

much again, Madam Chairwoman and Members, for having me 

here and holding this hearing on this very important subject. 

[The prepared statement of Secretary Thompson follows:]

Statement of the Hon. Tommy G. Thompson, Secretary, U.S. Department of 

Health and Human Services 

Good morning, Madam Chairwoman and members of the Subcommittee. I am 

honored to appear before you today to discuss ways the Federal government can 

help reduce medical errors and improve the safety of the health care services that 

Americans receive. 

In the last few years the Department of Health and Human Services (HHS) has 

developed a coordinated set of initiatives to identify and reduce threats to patient 

safety and improve the quality of patient care. While these initiatives are important, 

they are only a beginning. 

President Bush and I recognize that significant progress will only be achieved 

when the talents and energies of health professionals are fully engaged in improving 

the quality of care. We have been heartened by the recent emergence of several notable private sector patient safety initiatives. But much more needs to be done—

and can be done—to eliminate the barriers that discourage health care providers 

from participating, voluntarily and enthusiastically, in local and regional patient 

safety and quality improvement efforts. 

The main barrier, of course, is the fear professionals have that if they report some 

event or some condition that is less than perfect, their report will be used to stir 

up litigation rather than the fix the problem. They need assurances that if they report, the information will be used constructively, not destructively. The President 

made this point explicitly in his speech at the Medical College of Wisconsin, in Milwaukee, when he said, ‘‘We actually have a system that penalizes doctors for trying 

to prevent errors and avoid complications in patient care,’’ because when they discuss information about patient care they put themselves, or others, at risk of a lawsuit. As the President said, ‘‘This doesn’t make much sense. These good faith efforts 

do not deserve the punishment of a lawsuit.’’ He called on Congress to remedy this 

situation. 

I am pleased to say that the legislation this Committee is considering represents 

the change in direction that the President called for and that is essential to improving quality of care in this country. It will take us away from the blame game played 

after there has been an injury and will set us on the more productive path of working together to improve the system and to prevent adverse events from occurring 

in the first place, by encouraging a culture of learning and constant quality improvement in our health care system. 

The vast majority of doctors, nurses, and other health care professionals are dedicated, conscientious people who work long hours under very difficult circumstances. 

They are there when we need them. They would be a critical part of our front-line 

14

defense in the event of a bio-terrorism attack. They are heroes. And we should recognize this, to them and to ourselves. We should support, not attack them. 

Health professionals are not opposed to quality improvement. Just the opposite; 

they embrace it. We should support their efforts to improve quality. But it must be 

real and meaningful quality improvement, done in a supportive and cooperative 

way. The legislation this Committee proposes meets these important principles. 

Madam Chairwoman, your legislation provides the types of protections that the 

President believes are essential to foster the development and institutionalization 

of quality improvement efforts in our health care system. I commend you, and your 

colleagues, for your leadership in developing, and, we hope, moving this important 

legislation. 

The Patient Safety Challenge

The Institute of Medicine’s (IOM) landmark 1999 report, To Err is Human, alerted the nation to the patient safety challenge in ways that prior studies had not. The 

IOM estimated that between 44,000 and 98,000 Americans die each year as a result 

of medical errors, making them the eighth leading cause of death in the United 

States. More people die from medical errors than from automobile accidents, breast 

cancer, or AIDS. While there has been subsequent debate about the actual number 

of deaths, it is clear that the rate of medical errors is unacceptably high. 

I would like to highlight four of the IOM conclusions that are particularly relevant 

to today’s hearing. First, the elimination of medical errors will not be accomplished 

by attempting to identify and discipline the ‘‘bad apples’’. The IOM report concludes 

that errors are not solely the fault of individual doctors, nurses, and other clinicians; 

they are often ‘‘a failure in the process of delivering care in a complex delivery system.’’ System failures result from a complex interaction of people, technology, work 

processes, and working conditions, but few health care providers have expertise in 

the identification and analysis of contributors to system failures. 

Second, the IOM report cautions that if a patient experiences an adverse event 

during the process of care, this does not necessarily mean that a medical error has 

occurred. Most medical care entails some level of risk, and there can be complications or side effects, even unforeseen ones, from the underlying condition or from 

the treatment itself. We should not equate problem outcomes with bad practice, but, 

rather, we should strive to differentiate one from the other. 

Third, the IOM concluded that much can be learned from the analysis of errors—

from errors that result in serious patient injury or death as well as from errors that 

result in little or no patient injury, but which, when aggregated, can help identify 

patterns of system failures. To foster such analyses, the IOM urged health care organizations to implement non-punitive systems for reporting and analyzing errors 

within their organizations and encouraged the development of voluntary reporting 

systems. 

Fourth, the IOM concluded that health care providers need to be assured that if 

they report errors that are necessary to detect system problems, these reports will 

be used for that purpose in a culture of safety rather than unproductively as grist 

for the litigation mill. As the IOM report reminds us:

Patient safety is also hindered through the liability system and the threat of 

malpractice, which discourages the disclosure of errors. The discoverability of 

data under legal proceedings encourages silence about errors committed or observed. Most errors and safety issues go undetected and unreported, both externally and within health care organizations.

The failure to report errors hampers quality improvement efforts and threatens 

the quality of care for us. It also blocks our best efforts to improve the quality of 

health care information systems. If providers are reluctant to keep track of the information required to improve the quality and safety of health care delivery for fear 

of lawsuits, health care providers will continue to lag behind in electronic information systems, despite all our work to develop effective standards and support for 

21st century medical information systems. The IOM urged Congress to guaranty the 

confidentiality of data related to patient safety and quality improvement. 

Proposed Substitute for HR 4889

Madam Chairwoman, the Administration supports your efforts to pass your proposed substitute for HR 4889, and enact legislation to remove the liability barriers 

to improving quality and safety of health care during this session of Congress. Your 

proposal appropriately responds to the IOM recommendations and advances the Administration’s goal of facilitating health care professionals’ ability to improve the 

quality of our health care. 

The proposal assures doctors and other health professionals that if they report information to expert Patient Safety Organizations (PSOs), that information will be 

15

used for patient quality improvement efforts and will be kept confidential. This will 

encourage them to report, and will greatly increase the amount of data available 

for analysis by experts. Because the PSOs will receive information about more than 

one hospital and about more than one doctor, they will be able to detect patterns 

of good and bad practices that might not otherwise be noticeable on a single provider basis. They will be able to provide recommendations to local providers about 

system changes that the providers would not have been able to develop on their 

own. These new Patient Safety Organizations will promote collaboration and cooperation among providers on a regional basis. They will be proactive. 

The legislation recognizes that new ways of addressing quality are needed. If we 

have too many deaths and injuries from medical care now, the current system—

based on finding fault with individual providers—must not be working. The bill 

changes the focus along the lines outlined by the President, and sets the new direction he identified. There are four important elements of the bill that start us down 

a new and better path. 

First, the legislation focuses on system improvement. Rather than focusing on 

finding individual ‘‘bad actors,’’ it recognizes the fact that health care is delivered 

a part of a system. No person, not even a doctor, is perfect. But by looking at the 

system in which care is delivered, we can provide protection against human frailties. 

The role of the individual provider is critical, but systems can help providers, give 

them more information, and warn them about possible mistakes. The legislation will 

help identify system failures by enabling PSOs to examine a wide range and large 

number of providers. It will make it easier to bring information about how the system works, rather than reviewing the practices of one doctor or even one hospital. 

It will be able to gather information from a broad range of providers and see how 

the system works. 

Second, the legislation is forward looking and proactive. The Patient Safety Organizations will be able to examine processes and look at outcomes at various institutions, and make suggestions for improvements. Rather than focusing only on adverse events that have occurred, they will proactively identify better ways of delivering care. 

Third, it is pragmatic. It takes the common sense approach that the way to improve quality is to identify problems and make improvements. Instead of playing the 

blame game and litigating against our doctors for particular events that may or may 

not represent malpractice, the legislation recognizes the importance of preventing 

the adverse event from occurring in the first place. 

It recognizes that more must be done to improve quality and safety. The Administration fully supports effective enforcement programs based on available data to 

identify ‘‘bad actors’’ and remove them from medical practice. Information from medical records and other existing data sources will continue to be available for plaintiffs who are injured negligently as a result of medical errors. What is desperately 

needed, however, is new information to help prevent errors in the first place. And 

that is what this bill will provide. 

Finally, the bill recognizes the value of local and private quality efforts. We cannot improve quality by imposing solutions from Washington. There is often no one 

right way, and if there were, Washington might be the last to know about it. The 

best way to improve quality is to integrate it in the thoughts and processes and habits of the people who actually deliver care. Doctors and hospitals will be able to 

work together with local Patient Safety Organizations to identify problems and experiment with different ways of improving care. 

Current HHS Activities

Madam Chairwoman, your bill also complements existing HHS patient safety activities and, in turn, will help to guide our ongoing technical assistance to private 

sector initiatives, including the new Patient Safety Organizations. 

One of my major management initiatives at HHS has been to foster better coordination and integration of related activities that cross agency lines so that we can 

speak as ‘‘one Department.’’ And we are here today as one Department, with the 

Centers for Medicare and Medicaid Services joining the Agency for Healthcare Research and Quality in supporting this legislation. 

I am delighted to report that patient safety is an exemplary model of inter-agency 

coordination. We have created a Patient Safety Task Force that brings together 

three agencies with regulatory and data collection responsibilities—the Centers for 

Disease Control and Prevention, the Centers for Medicare and Medicaid Services, 

and the Food and Drug Administration—and our lead research agency on patient 

safety, the Agency for Healthcare Research and Quality. An important goal of the 

Task Force is to simplify the reporting of patient safety data to HHS agencies. The 

current system is unnecessarily burdensome. The same adverse event often needs 

16

to be reported in different ways on separate forms to different HHS components, 

and those who report the data never learn whether it was useful. 

The Patient Safety Task Force will replace this cumbersome system in two ways. 

At the front end, it is creating a single computer interface and standardizing the 

required information so that those who are required to report this information will 

only have to enter the data once and will only be asked to report data that will be 

helpful for patient safety analyses; the computer systems will then route the information to the appropriate HHS components. At the back end, the Task Force wants 

to ensure that we close the ‘‘reporting loop’’ by ensuring that the data are integrated 

and analyzed and that the non-identifiable data maintained by AHRQ and the results of its research can be searched in real time by those reporting the data. Patient safety improvement can only be a true public-private sector collaboration if 

those who report information also benefit from its analysis. Our experience in 

streamlining the reporting and analysis of data will be helpful as AHRQ provides 

technical assistance to the Patient Safety Organizations created by your bill. Let me now turn to specific initiatives at these agencies. With $55 million in dedi- cated funding in FY 2002 and a request of $60 million for FY 2003, AHRQ is now 

the leading funder of patient safety research in the world. Its current research portfolio includes 5 large initiatives, including support for 24 demonstration projects related to the collection, analysis, and use of patient safety data; 22 projects developing and testing state-of-the-art clinical informatics applications; 8 projects related 

to working conditions (such as fatigue, stress, and sleep deprivation); 23 projects fostering innovative approaches to improving patient safety; and 7 projects to develop, 

demonstrate, and evaluate new approaches to improving provider education related 

to patient safety. In addition, AHRQ will soon receive a report from the IOM on 

structured approaches for reporting patient safety data. That report, and the ongoing results of these and future research projects, will be shared with Patient Safety 

Organizations as they become operational. AHRQ’s FY 2003 budget submission requests $2 million to launch a Patient Safety Improvement Corps, experts who will work with State health departments and 

health care institutions to expand State and local capacity to use existing knowledge 

to identify and eliminate threats to patient safety. In recognition of the dearth of 

expertise in patient safety analysis, AHRQ will work with Patient Safety Organizations in the development of the Corps and will work to leverage existing Federal 

expertise across the government to ensure that these private sector initiatives can 

become operational as soon as possible. 

As you can see, AHRQ is well positioned to carry out its proposed statutory role 

as a ‘‘science partner’’ for Patient Safety Organizations. AHRQ sees the potential for 

tremendous synergy between the activities of Patient Safety Organizations and its 

ongoing national research. Moreover, the agency has already seen tremendous public and private sector interest—from States, health care institutions, health plans, 

and providers—in participating in such initiatives, if only protections of the type 

proposed in this bill can be provided for patient safety data. As a result, this legislation will greatly enhance AHRQ’s ability to carry out its patient safety mission. 

The Centers for Disease Control and Prevention (CDC) is pursuing a number of 

patient safety initiatives, including the National Electronic Disease Surveillance 

System (NEDSS). NEDSS will electronically link data collected by private-sector 

health care organizations and public health departments. It can serve as a model 

for how to increase efficiency, volume, accuracy, completeness and timeliness of reporting and exchanging information. In FY 2000, CDC provided funding for 14 

States to develop NEDSS systems. CDC has also provided funding for 32 States and 

three large metropolitan areas to assess their current health information systems 

and to determine how they can implement NEDSS specifications and standards. The 

FY 2003 budget request and the 2002 enacted level include $2 million for CDC to 

collect more information on hospital-acquired infections. 

The Food and Drug Administration (FDA) also has several initiatives underway 

to improve patient safety. For example, the FY 2003 budget includes an increase 

of $5 million above the $17 million provided in FY 2002 for the FDA to improve 

the collection and analysis of adverse event data, and to ensure that response to 

findings is timely and well communicated. FDA is working to improve labeling and 

packaging standards to reduce the chances of clinicians confusing drugs with similar 

names or making dosage errors, both of which can lead to adverse interactions between drugs. In addition, for biological products the FDA is requiring all establishments to report any event associated with biologics that were distributed by the 

manufacturer, including blood, blood components, and source plasma, that represents a deviation in manufacturing. FDA is also piloting a program of active collaboration with community medical programs to collect information about product 

safety that will supplement information from spontaneous reporting systems. And 

17

the FDA is developing a regulation to reduce drug administration errors by having 

bar coding technology apply to the administration of drugs. 

Further, as you are aware, the Centers for Medicare and Medicaid Services (CMS) 

already contracts with Quality Improvement Organizations (QIOs), formerly known 

as Peer Review Organizations (PROs), in each State to improve the quality of care 

and reduce errors through the collegial dissemination of best practices. They are accomplishing this in a number of ways, most of which are specified in our contract 

with the QIO. For example, CMS and the QIOs are working to improve clinical 

health outcomes of Medicare Beneficiaries and to prevent clinical disorders in a variety of health care settings. For instance, QIOs work with nursing homes in their 

states using the publicly reported Minimum Data Sets quality of care measures developed by CMS. QIOs also provide information to Medicare beneficiaries and their 

families, which can be used for selecting nursing homes, improving nursing home 

care, and obtaining a better understanding about nursing home care. Likewise, 

QIOs are working with home health agencies in their states, using the publicly reported OASIS quality of care measures developed by CMS. As with nursing homes, 

the QIOs provide information to Medicare beneficiaries and their families. QIOs also 

are continuing work with hospitals to reduce medication and other system failures 

related to acute myocardial infarction, heart failure, and pneumonia, and are adding 

a new clinical area focus, the prevention of surgical infection. The QIOs also focus 

some of their efforts on Critical Access Hospitals. Furthermore, in physician offices,

QIOs are continuing work in the areas of care for chronic diseases like diabetes and 

preventative services like mammography and adult immunizations for flu and pneumonia. In addition to these various clinical settings, QIOs are focusing on different 

populations. They will continue work to eliminate health disparities between certain 

medically underserved populations and the general population. We also have added 

rural beneficiaries to the list of the groups eligible for these projects. And QIOs will 

continue work to ensure that Medicare+Choice Organizations are part of CMS’ overall efforts to improve health outcomes and enrollee satisfaction for beneficiaries enrolled in a Medicare+Choice Organization. 

In addition to clinical quality improvement, QIOs are helping to improve patient 

safety and health through helpful information and effective communication. The 

QIOs play an active role in communicating publicly reported nursing home and 

home health agency quality of care measures; and provide assistance to providers 

and beneficiaries in their states in interpreting and using this information. Additionally, through coordination with JCAHO, the QIOs are assisting hospitals in 

their states in developing the infrastructure and tools to permit electronic self-reporting of quality of care measures. The QIOs also are continuing to conduct those 

communication activities required by law, such as preparing an annual report and 

providing beneficiary and provider information. Additionally, QIOs are establishing 

a Consumer Advisory Council to advise them regarding consumer-oriented activities. 

QIOs are also dedicated to improving beneficiary safety through Medicare beneficiary protection activities. The QIOs continue to provide review and beneficiary 

complaint responses as required by law and regulations. Additionally, the QIOs 

have implemented a new element of the beneficiary complaint response program utilizing the mediation process to supplement the more formal complaint review procedures. Moreover, a Payment Error Prevention Program has been revamped and included in the QIOs statement of work. Under the Hospital Payment Monitoring Review Program, the QIOs will continue to review medical records for coding and medical necessity in order to estimate national and statewide payment error rates for 

inpatient PPS services. Finally, CMS uses special studies to direct the QIOs to perform work or special projects that are not identified in the other tasks, but fall within the scope of our contract with them. 

Patient Safety Coordination Beyond the Department

Madam Chairwoman, I also want to note that my interest in improving the coordination of patient safety activities extends beyond my own Department. I recognize that other Departments have a strong interest and activities in patient safety, 

and it is critical that we not work at cross purposes. We are using the existing Quality Interagency Coordination (QuIC) Task Force, which includes all Departments, 

agencies, and entities with an interest in improving the quality of patient care, to 

coordinate the overall Federal response to the IOM’s report on medical errors. The 

QuIC has held a national summit to set the agenda on patient safety research, initiated a breakthrough series with the Institute for Healthcare Improvement to foster 

improvements in high-risk settings in health care facilities that the Federal government manages, and helped produce materials for dissemination to the public on 

steps that people can take to prevent medical errors from happening to them. 

18

We are also working with other nations to leverage our resources and share our 

knowledge. On October 10, 2001, the Secretary of State for Health in the United 

Kingdom (UK), Alan Milburn, and I signed a cooperative agreement to support collaborative activities in quality improvement and patient safety. Already there have 

been positive activities between the United States (US) and the UK in the areas 

of adverse event reporting and patient safety research. We are working closely with 

the newly formed National Patient Safety Agency (NPSA) in the UK to standardize 

reporting formats and coordinate our research agendas. As I speak, UK and US patient safety researchers are meeting today to explore common research methods for 

patient safety. 

Conclusion

Madam Chairwoman, I look forward to working with you on this legislation and 

would like to convey, once again, the President’s appreciation for your leadership 

in this area. I would be happy to answer any questions that you may have. Thank 

you.

son. I would like to just highlight, and then I will move to Members 

Chairman JOHNSON. Thank you very much, Secretary Thompf for questions, a couple of statements in your written testimony. 

These statements enlarge on the point that you have made very 

well, and that is that the point of an errors reporting system is system change, and you get system change only through a deep knowledge of lots of little things that are happening. 

You say in your testimony that errors that result in little or no 

patient injury can be aggregated to help identify patterns of system 

failure. It is not just errors that result in death or injury that can 

help you improve the quality of the health care system. It is all 

those little miscellaneous things that people observe and see. Some 

of them are not even actions taken. They are just thoughts about 

how actions could be better taken or possibilities avoided, as in the 

case of the anesthesiologist. 

You also say the best way to improve quality is to integrate quality in the thoughts, processes, and habits of the people who actually deliver care. I think those statements are extremely important. 

You cannot integrate quality into people’s thoughts and actions if 

at the same time half their mind is compelled by fear. 

So, the underlying issue in this bill is to put in place a system 

that can use all those little perceptions and experiences of the actual online, frontline care givers who provide health care to Americans. These people use from their observations and experience, 

whether injury is involved, whether death is involved, or whether 

nothing like that is involved, their knowledge and experience to improve the systems and the environment of safety in our institutions. So, I thank you for your testimony and I am going to turn 

to Members. Mr. Chairman, would you like to question? 

Chairman THOMAS. No. 

Chairman JOHNSON. Mr. Stark, would you like to question? 

Mr. STARK. Thanks. Governor, welcome again. Just a couple of 

items here. One, it is my understanding that you or the Department is about to receive a National Quality Forum (NQF) report 

sometime this year and that they, I have also been informed, will 

have perhaps approximately 35 precise steps that should be taken 

to reduce medical errors, and this is a result of a study that has 

gone on for some time where it has taken patient safety information and reports from hospitals around the country. 

19

Would it not be a good idea for us to not only receive that report, 

but the other reports that you are spending $55 million on to see 

if we can focus not just on the voluntary side, because in your testimony, you do indicate that the IOM suggests voluntary reporting, 

but whoever typed your statement left out the other part of what 

IOM recommends and that is the mandatory reporting system on 

the sentinel events that they also feel should be part of a system. 

So, my sense is that what we are discussing here today is only 

half a loaf and your Department has a tremendous amount of information that could be used in cooperation. It is my understanding 

we have had no meetings with your staff to kind of coordinate 

where we are. I think we have learned a tremendous amount since 

the report in 1999 and all that this bill seems to do is release the 

hospitals from any liability, but we are not going forward. For example, we know, and you know, Mr. Secretary, I believe, that computerized prescribing will save lives. 

Secretary THOMPSON. Absolutely. I brought it up. 

Mr. STARK. I think we also know that requiring, and the only 

way we could do that is through a Federal law, the use of safe needles, which is going to reduce medical accidents. I think we also 

know, and we have got about 90 or 100 Members of Congress who 

subscribe that reducing mandatory overtime for professionals like 

nurses will have them making their rounds when they are not too 

tired to perform, and that could reduce errors. 

So, there are a lot of things that we all know can help. In some 

cases, they may be worth mandating. We do that. You know, we 

would not have air bags in cars if we did not mandate them. If we 

waited for the auto industry to do it, you and I would still be wondering about that. 

So, what I guess I am saying is, could we not come together with 

the information that you have that you are about to receive and 

broaden the scope of this to really come up with a Federal policy 

that would not hurt the States, who some States are ahead of us. 

Secretary THOMPSON. That is right. 

Mr. STARK. Some States have a combination, and some are having trouble. I would hate to forestall that or preempt it by doing 

really too little. So, I guess my question is, would it not be a good 

idea for us to wait and work together to bring all of the research 

that—and I am not talking a long time, I am talking a couple of 

months and you are going to have this information, and then we 

could pick and sort and decides what needs legislation, what you 

can do administratively, and expand on the Chairman’s initial step 

in this direction. 

Secretary THOMPSON. Thank you, Congressman. I would like 

to respond by first thanking you for your interest in the subject, 

Congressman Stark, and secondly to tell you that you know quality 

improvement is not a static event. It is going to be an ongoing 

thing, and no matter what we do today, we are going to have to 

continue to address it in the future. 

I am a big believer in accumulating the data and then acting, but 

AHRQ has been working on this under John Eisenberg, under his 

late leadership, which had been exemplary. 

Mr. STARK. Right. 

20

Secretary THOMPSON. I have worked with him on many things. 

This is a cause celebre for AHRQ and for the Department. We want 

to move, and we think that this is a giant step forward, Congressman Stark, and that is why we think the Congress should act. 

We think that this proposal is a step in the right direction. There 

are going to be further steps, as you have indicated. A lot of the 

steps you have indicated, I could strongly support and believe that 

Congress should act in the future. This one, I do not think we 

should delay taking action on this one because I think it is so important. I think it needs to be done and this is a first step. 

Second, bar coding is something that we need to do. Grocery 

stores have it. Why do we not have it in the hospitals and clinics? 

Third, I would strongly suggest we take some of the fraud and 

abuse money and put it into a mini-Hill-Burton law for use for new 

technology for doctors and clinics. We would be able to solve a lot 

of the problems if we did that. 

There are so many things out there, but as you know much more 

so than I do, Congressman Stark, that at the end of the session, 

you try and get as much done as possible. I think this is doable. 

I think we should do it. It is a good step, and I would like to urge 

your support, Congressman. 

Mr. STARK. Do you think that there is any danger that this bill 

could preempt the States that now have mandatory reporting and 

frustrate their efforts to do that? 

Secretary THOMPSON. I do not, because 44 States right now 

across the country, including my home State of Wisconsin and your 

State of California and your former home State of Wisconsin, have 

peer review. This is an extension of peer review, because in most 

of those 44 States, they have put into the law that the peer review 

conference in the work product is not admissible into court. Not 

every one of them is the same, but the City of Washington, DC, 

probably has got the best law on the books in regards to that. 

So, I do not think it would in any way deter what the States are 

doing. In fact, I think it would encourage States to adopt further 

progress in quality improvement. We need it. We need quality improvement, especially in the health care field, and I think with 

technology and with the Patient Safety Organizations, we are going 

well down that road to helping to improve it and that is what I 

would strongly urge this Congress to take. 

Mr. STARK. You would have no objection to States that require, 

in addition, mandatory reporting, in addition to whatever we do? 

Secretary THOMPSON. I have none whatsoever. I am a big 

States’ righter and if they want to do it, fine with them. 

Chairman JOHNSON. Mr. Crane? 

Mr. CRANE. Thank you, Madam Chairman. Mr. Secretary, in 

your testimony, you state that Quality Improvement Organizations 

(QIO) in each State are currently working to improve the quality 

of care and reduce errors through the collegial dissemination of 

best practices. What interaction would the Quality Improvement 

Organizations have with the PSOs, and how would the QIOs interpret and use the data collected by the PSOs? 

Secretary THOMPSON. I think they can work very collaboratively, Congressman Crane, and they could be synergistically 

connected. I think that Patient Safety Organizations are going to 

21

be much broader and are going to allow for much more systemic 

changes in the delivery of the medical system and improvement of 

quality. 

What is happening at the State level is more a collegial peer review kind of thing, and I believe that Quality Improvement Organizations are also of that category. The Patient Safety Organizations 

are going to be, I think, much broader and are going to allow for 

us to look at much more regional operations and hospitals and doctors and find out, you know, maybe small mistakes that, accumulated, could be changed and you could really have an impact on the 

system, like the anesthesiologists did. 

They found that in half the hospitals—I do not know if half, but 

a good share of the hospitals, you turn the nozzles one way to get 

the anesthesia out, and in other hospitals, they turn the other way, 

causing a lot of mistakes. They looked at it, and they examined it, 

and in standardizing it, they now have been able to reduce the 

number of deaths from 1 out of 10,000 to 20,000 to now 1 out of 

200,000 to 300,000. So, it is a tremendous improvement. We think 

we can do the same way with this legislation. 

Mr. CRANE. Quality Improvement Organizations might use the 

data collected by Patient Safety Organizations to inform Medicare 

beneficiaries of the level of care provided in certain areas without 

establishing best practice guidelines, is that not correct? 

Secretary THOMPSON. Well, that is entirely correct, but we just 

hope the latter is that they will develop best practices. This is the 

reason we are going to, because we think that this legislation is 

going to encourage best practices. We think that by setting this up 

and allowing this regional collection of data and being able to solve, 

hopefully, the problems, that this is going to establish standards 

that will create best practices, and that is what we are hoping is 

going to be the net result of this legislation. 

Mr. CRANE. That is the hope of all of us and best of luck to you. 

Secretary THOMPSON. I know it is. 

Mr. CRANE. Thank you. 

Secretary THOMPSON. Thank you, Congressman Crane. 

Chairman JOHNSON. Mr. English? 

Mr. ENGLISH. Thank you, Madam Chair, and thank you, Mr. 

Secretary, for taking on what I think is a very difficult issue and 

testifying on behalf of what I think has been a very fine bill that 

the Chairman has spent a lot of time on and has produced. 

I wonder with regard, as we try to create this regime to deal with 

the problem of medical errors, how important is it to have standards that are flexible enough to allow for new innovations in health 

care that are workable in a variety of settings, and do you feel that 

this bill meets that standard? 

Secretary THOMPSON. We do, and to answer your second question first, we do believe it does. Second, we believe that standards 

should be flexible enough to allow for new innovations. 

You, Congressman English, have been a leader in innovations in 

the medical field for as long as you have been in Congress and I 

applaud you for that. The only way you move ahead, especially in 

the delivery of health care systems, is by innovating. With the 

changing technology and the changing science out there, you have 

to allow for that. The embryonic stem cells, the research that is 

22

going to come out of that, is going to be something that is going 

to, hopefully, provide for new therapies, and you have got to provide for that. There is new technology out there that is going to 

help to deliver and, hopefully, save the medical delivery system in 

America. It is going to have to be allowed to be able to be modified 

and changed and improved, all of these things. 

So, you want to make sure that the standards are there, but also 

to allow for the flexibility to provide for innovation. That is what 

this country is all about, and especially in the field of medicine, 

which everybody is looking for the new therapy, the new drug, the 

new technology that is going to help cure the maladies and also improve the safety of patients. 

Mr. ENGLISH. Thank you, Mr. Secretary. Madam Chair, I will 

yield back the balance of my time. 

Chairman JOHNSON. Thank you, Mr. English. Mr. McDermott? 

Mr. MCDERMOTT. Thank you, Madam Chair. I come at this 

with sort of a personal feeling about it, having worked in the days 

when you worked 36 hours on and 12 off. I have some feeling about 

medical errors and what may bring it about. One of the reasons I 

think this bill of nursing is one of those things we could do, I think 

mandatory overtime ought to be something that we prohibit. 

I go beyond that. I have also worked on Peer Review Organizations (PRO). I have gone into hospitals all over Washington State 

and I discovered the best way to figure out who the bad doctors 

were was to go down and talk to the head nurse in the operating 

room and she could tell you in about 2 minutes what was going on 

in that hospital. The PROs and that whole operation was an attempt. 

We in Washington State now have a situation of mandatory reporting of major mistakes that have caused death or major problems, and that is still discoverable in a lawsuit. One of the things, 

I am not clear on what you are saying. I do not think you want 

anything to be discoverable, and in some way, we have got to solve 

that problem, because if there has been an accident or an injury 

or some kind of problem in the hospital, someone has a right to 

have reimbursement or to have a settlement——

Secretary THOMPSON. Sure. 

Mr. MCDERMOTT. So, you have got to be able to get the data, 

but if somebody says, well, this has been reported as an incident 

in our voluntary system, it is exempted by Federal law from being 

discovered, you prohibit the resolution of a case, it seems to me. 

I am sure you have thought of it, and I do not want you in a Federal law to override what we have set up in the State of Washington. You said it will not preempt the State of Washington. I am 

not sure if that is correct. 

Secretary THOMPSON. That depends upon how the law is written. 

Mr. MCDERMOTT. Yes, I understand, but I think it is one of 

those issues we have to clarify. The larger question is, if you make 

it all voluntary and then protect it with secrecy—the IOM did not 

suggest that. They said reportable incidents are protected, but 

when it comes to a death or more serious—they sort of distinguish 

between significant events and near-misses. Explain to me how, if 

23

you protect it all by Federal law, any of it is ever going to be discovered, if you treat it simply as an issue of improvement of care. 

Secretary THOMPSON. You have thrown out several things. If 

I could try and respond to several of them, I will try, Congressman. 

Mr. MCDERMOTT. I am sorry if my question was unclear. I am 

not a lawyer. 

[Laughter.] 

Secretary THOMPSON. First off, in regards to nursing, I think 

that we have to do a heck of a lot more to encourage young people 

to go into the nursing and all health fields, and I thank you for 

your leadership and all of the Congresspeople in regards to the bipartisan legislation in nursing improvements. It was well thought 

out, it was well executed, and I appreciate it. 

Mr. MCDERMOTT. Would you mind if it was part of this legislation? 

Secretary THOMPSON. Pardon? 

Mr. MCDERMOTT. Would you mind if we made this as an 

amendment to this legislation, the prohibiting of mandatory overtime? 

Secretary THOMPSON. That is not for me to say, sir. I am talking about the nursing professions, encouraging people to get into 

it and the funding of nurses to go into teaching. 

Mr. MCDERMOTT. Okay. 

Secretary THOMPSON. Second, in regards to the litigation, 

there is nothing in this proposal that would prevent anything being 

discovered that is discoverable today. It is only the extension, only 

the material that goes to the PSOs would not be discoverable. 

If, in fact, there is an underlying record that could be subpoenaed into court, you could still subpoena the nurse who is at the 

hospital. You could still subpoena the doctor and take depositions 

of those individuals. That is all discoverable. Nothing in this legislation would prevent anything that takes place currently in a Federal lawsuit to not be permitted. Only the extra step, the step of 

quality improvement, the step from getting the information collected from the incidents and from the various hospitals, that 

would be privileged and that would not be discoverable. 

Mr. MCDERMOTT. If that is true, why not make it mandatory 

that it be done? I understand that you do not like—I understand 

the philosophy of government that does not like to make the government force people to do things, but it seems to me in this issue 

that if you make it mandatory, since it is still discoverable and people are protected on that side, I do not see why anybody would not 

want to have that information gathered for hospitals to look at 

their system and discover a more good way for the patients. 

Secretary THOMPSON. I am fairly certain, Congressman, that 

once you start this, that is going to be the normal course of business, that even without requiring mandatory, it is going to be considered as a good health field, good health process to be able to do 

this, and I think you are going to encourage more to get started 

in this. I think that is what the Chairperson is looking for, is to 

get more buy-in. By doing it voluntary, I think you are getting a 

lot more initial buy-in, and then by that time, I think it is just 

going to be a normal course of business, and everybody is going to 

do it. 

24

Mr. MCDERMOTT. I wish I had your faith. 

Secretary THOMPSON. I am an Irishman, Congressman. I am 

very optimistic. I only wish you were as optimistic as I was, sir. 

[Laughter.] 

Mr. MCDERMOTT. I yield back the balance of my time. 

Chairman JOHNSON. Thank you. Congresswoman Thurman? 

Mrs. THURMAN. Thank you, Madam Chairman. Thank you for 

having this hearing today. I know that we have worked hard to try 

to come up with a piece of legislation and move it along. In saying 

that, I do think that there have been some issues that we have 

raised and certainly some that Mr. McDermott just questioned and 

talked about were of some concerns to us. In saying that, and I do 

not know if, Mr. Secretary, you have seen the letter from the National Academy for State Health Policy——

Secretary THOMPSON. I do not think I have. 

Mrs. THURMAN. I will make sure you get a copy of this, because 

it is somewhat alarming to me. We have 20 States now, I believe, 

that are already doing a mandatory reporting system, and what 

they say here is that we actually, or IOM went out and said to 

these States, you need to do this. We have asked you to do this, 

and we particularly are concerned about collecting and standardizing information about adverse events that result in death or serious harm. 

I think that in this particular bill we are looking at, we really 

have no standards. We do not talk about whether it is harmful, 

how harmful. We really do not go into much detail. It just seems 

to be all information. So, I think there is a real concern that we 

will usurp what has happened in the States. 

I remember when we first started these hearings back in 1996, 

when Chairman Thomas was the Chairman of the Subcommittee, 

we had several people come in and talk to this Committee and one 

of the things that they used in their testimony was actually the 

program that had been set up in Florida and I am very concerned 

that we may end up in a result not making this mandatory or, in 

fact, usurping what they are doing. In their estimation, the public 

is given some safeguards by having this, including to the point 

where they have a website that people can go look and see what 

is going on. So that, I think, is a real question for us in this, and 

I do believe that is a debatable question and it has been debate 

with and among this Committee over the last couple of months, 

trying to figure out how we could move forward. I am interested 

in——

Secretary THOMPSON. Do you not think, Congresswoman Thurman, we could work that out? Do you not think that we could work 

out the legislation with the Chairwoman——

Mrs. THURMAN. Mr. Secretary——

Secretary THOMPSON. And the Department and get something 

that is compatible? 

Mrs. THURMAN. That——

Secretary THOMPSON. I think we all want to move in that direction and get it done and——

Mrs. THURMAN. I am not questioning that, and as I said, I 

think the Chairwoman, if you would have seen the bill we started 

25

with to where we are, she has worked very diligently and has 

worked at this. This just happens to be an issue——

Secretary THOMPSON. Yes, I understand. 

Mrs. THURMAN. That sometimes you just do not come to some 

conclusion, and quite frankly, and we have had those conversations, I would have a very difficult time supporting something that 

did not track what my own State legislature put in——

Secretary THOMPSON. I understand. 

Mrs. THURMAN. That is to say that I think she has done a fabulous job in this. There is another area that you mentioned, I 

think, a little bit in your testimony, or not in your testimony but 

in conversation, I think, maybe with Mr. English, on the technology 

part, that we should use fraud and abuse dollars to help pay for 

some of this. What I would like to know is, because in this bill 

there are no dollars to help——

Secretary THOMPSON. Right. 

Mrs. THURMAN. In a bill that Mr. Houghton and I introduced, 

we had money in that piece of legislation to, in fact, help. Can you, 

in fact, then carry this out administratively? 

Secretary THOMPSON. No, I cannot. 

Mrs. THURMAN. Okay. So we need to figure out a way——

Secretary THOMPSON. Congresswoman, I have been talking 

about this for a long time. I really—it bothers me immensely as 

Secretary of Health and Human Services to walk into a grocery 

store and know that a grocery store is more technologically advanced than a lot of our hospitals and clinics across America. When 

I talk to people in the health field, hospital administrators and so 

on, and they say the cost is so much that they cannot afford it because the changing of the technology, it is antiquated by the time 

they get it in and, therefore, they do not want to make the investments. 

So, I believe that we should have some sort of a demonstration 

fund. I think we can get to a paperless system in hospitals, and I 

have been talking about that for a long time, so that you could use 

your technology to get in and you would reduce the rates. If we 

could somehow use—the fraud and abuse money, I know, is—I am 

talking for myself now, nobody else—I just think it would be something that the medical profession would really rally around and 

say, you know, people that have done something wrong, we take 

money away from them, but instead of wasting, or not wasting 

money, but putting the money someplace else, identify the money 

to do something to improve the system. 

Mrs. THURMAN. You and I agree. I mean, that is why when we 

wrote the piece of legislation we did, we figured that, I mean, not 

only for large hospitals, but a lot of rural hospitals who are going 

to be affected by this. Let me just say two things at the end of this. 

Secretary THOMPSON. Okay. 

Mrs. THURMAN. Number one—I do not know, which do I do? Do 

I give the good or the bad first? I was really not very happy with 

the Graduate Medical Education issue on psychology, again. I 

mean, it was something this Committee worked on, had worked on, 

had been a proposed rule, had gone through its time period, and 

still we are back where we were 4 years ago. You know my feelings 

about that. 

26

Secretary THOMPSON. I know you——

Mrs. THURMAN. The good news is, I do want to thank you very 

much for the dollars that you just gave to Florida on the Ron Silver 

prescription drug for our low-income seniors. We do appreciate 

what you have done in that, and also the demonstration programs 

on some of the HMO Medicare+Choice things, so——

Secretary THOMPSON. We are trying a lot of demonstration programs, and on the psychologists, well, let us keep working on it. 

Mrs. THURMAN. I would like something more than that, but we 

will talk about it. 

Secretary THOMPSON. Thank you. 

Mrs. THURMAN. Thank you. 

Secretary THOMPSON. Thank you very much, and thank you. 

Chairman JOHNSON. Thank you very much, Mr. Secretary. I 

know you have to leave and I appreciate your being here. I think 

we have completed our questions and we have kept the other panel 

waiting so long. 

I do want to announce two things. First of all, we did just get 

a letter from Florida and the Greater New York area and they 

have very positive things to say about the voluntary reporting requirements and the interoperability standards, so we will be working on that. 

Mrs. THURMAN. Madam Chairman, I know that, but I also 

would go back to the letter that I think the State health people 

said, and that was that we also need to look at the breadth of that, 

because they are working well. 

Chairman JOHNSON. We will on the succeeding panel have a 

chance to ask those questions in regard to State issues. 

We have a 15-minute vote. We have about 5 minutes left before 

that concludes. Then we have two 5-minute votes, so we will reconvene at 1:00 with the final panel. Thank you very much. 

Before I recess the Committee, I am going to insert the statement of Bill Coyne for the record. Congressman Coyne has asked 

permission to insert his statement. 

[The statement of Mr. Coyne follows:]

Statement of the Hon. William J. Coyne, a Representative in Congress from 

the State of Pennsylvania 

I am pleased that the Ways and Means Health Subcommittee has chosen to hold 

a hearing on medical errors. I have been concerned about the medication error aspect of this problem for quite some time. All medical errors are unacceptable, and 

the Federal government must work with the health care industry toward the goal 

of dramatically reducing such errors. 

In 1993, Steve Twedt of the Pittsburgh Post-Gazette did a series of articles on 

medication errors. The Pittsburgh Post-Gazette reported that the newspaper’s study 

of 250 hospital pharmacists across the country produced an estimate of 16,000 medication errors in the surveyed institutions in 1992, with 106 of these errors causing 

patient deaths. Some of these errors were made by physicians, some by hospital personnel, some by pharmacists, and some by patients. 

The Post-Gazette reports offered clear evidence that a significant number of people die or become ill every year because of medication errors. Furthermore, David 

Work, the Executive Director of the North Carolina Board of Pharmacy, testified at 

a Ways and Means hearing on medication errors in 1995 that ‘‘about 10,000 deaths 

occur nationwide from pharmaceuticals each year.’’ There was certainly no doubt 

that the system for monitoring medication errors had to be improved. 

In 1993, I introduced The Safe Medications Act. This legislation would have required that deaths due to the prescribing, dispensing or administering of drugs be 

reported by the health care facility in which the error occurred to the U.S. PharmaVerDate jul 14 2003 07:07 Sep 04, 2003 Jkt 086199 PO 00000 Frm 00030 Fmt 6633 Sfmt 6621 E:\HR\OC\86199A.XXX 86199A
27

1 www.bristol-inquiry.org.uk/brisphase2.htm; accessed 6 March 2000. 2 Kohn LT, Corrigan JM, Donaldson MS, eds. To err is human. Building a safer health system. Washington, DC: National Academy Press, 1999. 3 Charatan F. Clinton acts to reduce medical mistakes. BMJ 2000; 320: 597 [Full Text]. 

copeia, a private non-profit organization directed by Congress to set drug standards. 

Health care institutions covered by this bill included pharmacies, hospitals, longterm care facilities, ambulatory care facilities and physician offices. Reports would 

have had to be made within 10 working days from the date the error was discovered. The Secretary of Health and Human Services would have worked with the 

U.S. Pharmacopeia and appropriate health care provider associations to notify and 

alert health care providers and manufacturers of potential problems. Information reported to U.S. Pharmacopeia would have remained confidential. I re-introduced this 

legislation in subsequent Congresses. 

In 1998, U.S. Pharmacopeia unveiled a voluntary reporting system for all errors, 

not just those resulting in death. Health care providers report the errors and U.S. 

Pharmacopeia organizes them into a searchable database. They also notify health 

professionals about the most common medication errors and their causes. This voluntary initiative constituted a commendable first step in reducing the number of 

deaths caused by medical errors. 

In 1999, the Institute of Medicine released the report, To Err is Human. The 

study described a fractured health care system that is prone to errors and detrimental to safe patient care. While this report prompted some debate on the issue, 

Federal legislation to reduce medical errors has not yet been enacted. 

In 1999, I joined my colleague Congressman Cardin in introducing the Medicare 

Chronic Disease Prescription Drug Benefit Act of 1999. This legislation would have 

provided for a chronic disease prescription drug benefit under the Medicare Program. Furthermore, it contained language that would have ensured that appropriate 

safety mechanisms were in place to prevent medication errors in this program. The 

legislation would have directed the Secretary of Health and Human Services to establish a model for comprehensive educational programs to assure appropriate prescribing, dispensing, and use of such covered drugs. Unfortunately, Congress has 

failed to act on Medicare prescription drug legislation as well. 

Finally, I want to thank the Pittsburgh Regional Healthcare Initiative for their 

hard work in reducing medical errors in Southwestern Pennsylvania and for coming 

today to share their experience. 

The issue of medical errors is of great importance and urgency. Thousands of lives 

are—literally—on the line. I am pleased to see that the Ways and Means Health 

Subcommittee is exploring this issue, and I hope that the Ways and Means Health 

Subcommittee and Full Committee will work together in a bipartisan fashion to find 

a prompt solution to this growing problem.

to insert an editorial, ‘‘Safe Health Care: Are We Up To It?’’ for the 

Chairman JOHNSON. Congressman Stark has asked permission 

f record. 

[The information follows:]

British Medical Journal 

March 18, 2002

Editorials 

Safe health care: are we up to it?

We have to be

In the 8 months since we put out the call for papers for this special issue of the 

BMJ devoted to medical errors, the landscape has changed considerably. In Britain 

the Bristol Inquiry has continued to focus professional and public attention on patient safety in a manner unprecedented both for its depth and for the extent of professional involvement.1 In the United States the recent publication of the report To 

Err is Human by the Institute of Medicine of the National Academy of Sciences 2

received extraordinary media coverage as well as prompt responses to its recommendations from the President and Congress.3

The error prevention ‘‘movement’’ has clearly accelerated. As the papers in this 

issue bear witness, major changes are occurring in the way we think about and 

carry out our daily work. For practicing physicians, some of the ideas and practices 

described here may be mind bending, or at least mind stretching. But most of the 

28

4 Wu A. Medical error: the second victim. BMJ 2000; 320: 726–727 [Full Text]. 5 Helmreich RL. On error management: lessons from aviation. BMJ 2000; 320: 781–785 [Full 

Text]. 6 Espinosa JA, Nolan TW. Reducing errors made by emergency physicians in interpreting 

radiographs: longitudinal study. BMJ 2000; 320: 737–740 [Abstract/Full Text]. 7 Nightingale PG, Adu D, Richards NT, Peters M. Implementation of rules based computerised 

bedside prescribing and administration: intervention study. BMJ 2000; 320: 750–753 [Abstract/

Full Text]. 8 Bates DW. Using information technology to reduce rates of medication errors in hospitals. 

BMJ 2000; 320: 788–791 [Full Text]. 9 Gaba DM. Anaesthesiology as a model for patient safety in health care. BMJ 2000; 320: 785–

788 [Full Text]. 10 Reason J. Human error: models and management. BMJ 2000; 320: 768–770 [Full Text]. 11 Nolan TW. System changes to improve patient safety. BMJ 2000; 320: 771–773 [Full Text]. 12 Reinertsen JL. Let’s talk about error. BMJ 2000; 320: 730 [Full Text]. 

insights and solutions will, we think, have resonance for all those who strive to provide safe care for patients. All physicians, after all, have had the unwelcome experience of becoming what Wu calls ‘‘the second victim,’’ being involved in an error or 

patient injury and feeling the attendant sense of guilt or remorse as responsible professionals.4 Familiar, too, are Helmreich’s findings that doctors, like pilots, tend to 

overestimate their ability to function flawlessly under adverse conditions, such as 

under the pressures of time, fatigue, or high anxiety.5

Some of the solutions reported here are as simple as teaching emergency room 

doctors to read x ray films6; others require substantial capital investment.7 The new 

world of automation described by Bates and by Gaba seems ever closer,8 9 and, although every new technology will inevitably introduce new forms of error, it is high 

time for medicine to enter the computer age. We should now hope that the death 

knell has at last been sounded for the handwritten paper prescription; and the 

paper medical record, a dinosaur long overdue for extinction, may at last be en route 

to replacement by far more useful and reliable automated systems. 

But, several of these authors warn us, making the more fundamental and lasting 

changes that will have a major impact on patient safety is much more difficult than 

simply installing new technologies. There are no ‘‘quick fixes.’’ We must re-examine 

all that we do and redesign our many and complex systems to make them less vulnerable to human error.10 11 The necessary changes are as much cultural as technical. Creating a culture of safety requires attention not only to the design of our 

tasks and processes, but to the conditions under which we work—hours, schedules 

and workloads; how we interact with one another; and, perhaps most importantly, 

how we train every Member of the healthcare team to participate in the quest for 

safer patient care. 

We have already learnt a great deal from the early experiences of error reduction 

in healthcare organizations. First, we have discovered an immense reservoir of creativity and motivation among healthcare workers of all kinds. When given the opportunity to help, when the barriers of shame and punishment are removed, doctors, 

nurses, pharmacists, and others eagerly work to improve safety, implementing best 

practices or developing new ones. 

Secondly, we have learnt again that leadership is an essential ingredient of success in the search for safety, as it is throughout the enterprise of quality improvement. In the absence of commitment from professional and organizational leaders, 

efforts will be fragmentary and uncoordinated and will have only minor effects. We 

need leadership at all levels. While local ‘‘champions’’—individual doctors, pharmacists, or nurses—can, by their enthusiasm, motivate others to make improvements, major systems changes require direction and support from the top—leaders 

who communicate their own commitment by insisting on safety as an explicit organizational goal backed by adequate resources. The test, as Reinertsen tells us, is 

that senior managers feel personally responsible for each error.12

Thirdly, we have learnt that the problem of medical error is not fundamentally 

due to lack of knowledge. Though clearly we have much more to learn about how 

to make our systems safe, we already know far more than we put into practice. Simple measures of known effectiveness, such as unit dosing, marking the correct side 

before surgery on paired organs, and 24 hour availability of pharmacists and emergency physicians, are often ignored. Health care alone refuses to accept what other 

hazardous industries recognized long ago: safe performance cannot be expected from 

workers who are sleep deprived, who work double or triple shifts, or whose job designs involve multiple competing urgent priorities. Based on currently available 

knowledge, constructive, effective changes to improve patient safety can begin at 

once. 

29

If we can mobilize our resources and make safety our priority, health care can 

make tremendous strides in the next few years. But today’s culture of blame and 

guilt too often shackles us. Achieving the culture we need—one of learning, trust, 

curiosity, systems thinking, and executive responsibility—will be immensely difficult. Harder still, we must now accomplish this cultural change under the spotlight 

of a newly aroused public that, given our track record, is understandably doubtful 

that health care can, on its own, do what needs to be done. Indeed, the public’s 

doubt in our commitment may be all too well founded. In truth, no other hazardous 

industry has achieved safety without substantial external pressure. Safe industries 

are, by and large, highly regulated. Health care’s track record of failure to act on 

over three decades of accumulating evidence of medical errors offers plenty of ammunition to those who claim that we may need to be forced to do what is, at bottom, 

right. 

The need is obvious, and the mandate is clear. Will we respond adequately and 

fast enough? Will hospitals and healthcare organizations get serious enough, soon 

enough, about patient safety? Will they make the changes that are needed, and will 

they be willing to hold themselves accountable for achieving improvements? Can we 

accept the legitimacy of the public’s right to know when serious accidents occur, and 

can we honor the public’s legitimate expectation that we will admit our mistakes, 

investigate them, and make the changes necessary to prevent them in the future? 

As we enter the new century, a key lesson from the old is that everyone benefits 

from transparency. Both the safety of our patients and the satisfaction of our workers require an open and non-punitive environment where information is freely 

shared and responsibility broadly accepted. 

Are we ready to change? Or will we procrastinate and dissemble—to lament later 

when the inevitable regulatory backlash occurs? It may seem to some that the race 

for patient safety has just begun, but the patience of the public we serve is already 

wearing thin. They are asking us to promise something reasonable, but more than 

we have ever promised before: that they will not be harmed by the care that is supposed to help them. We owe them nothing less, and that debt is now due. 

Lucian L Leape 

Adjunct Professor of Health Policy 

Harvard School of Public Health, Harvard University 

Boston, MA 02115, USA

Donald M Berwick 

Chief Executive Officer 

Institute for Healthcare Improvement 

f Boston, MA 02215, USA

Chairman JOHNSON. The Committee stands in recess. 

[Recess.] 

Chairman JOHNSON. The Subcommittee will come to order. My 

apologies to the panel for the delays. These things are beyond our 

control. Thank you. We will begin with Dr. Leape of the Harvard 

School of Public Health. Thank you for yours and Dr. Berwick’s 

help, and of others from the Committee as we have developed this 

legislation. I appreciate it. 

STATEMENT OF LUCIAN L. LEAPE, M.D., ADJUNCT PROFESSOR 

OF HEALTH POLICY, HARVARD SCHOOL OF PUBLIC HEALTH, 

HARVARD UNIVERSITY, CAMBRIDGE, MASSACHUSETTS 

Dr. LEAPE. Thank you, Madam Chairman, and Mr. Stark, Members of the Committee, for the opportunity to meet with you, and 

thank you, Madam Chairman, for your leadership in safety. We all 

appreciate it and look forward to working with you. 

I think it is fair to say that in spite of all the gloomy news, 

progress in patient safety in the past few years has really been astounding. There has been an incredible amount of activity since the 

Institute of Medicine report came out now not quite 3 years ago; 

not as much as we would like, never as fast as we would like, but 

30

significant progress nonetheless. Hospitals are changing their systems, particularly in medication systems. Hundreds have reorganized what they do. Health care systems throughout the country 

are leading in systems change. Regulators are intensifying their efforts. Coalitions have sprung up in many States, bringing together 

stakeholders to work on safety. I think there is no question safety 

has become a priority in health care and it is about time. 

The Federal Government, I think, has played an important role 

in this and the proposed legislation, I believe, will expand that in 

the proper way. I would like to comment on just several aspects of 

it briefly. 

The first, the Center for Patient Safety, I think is very important. The Agency for Health Care Research and Quality has been 

the leading force in the safety movement. Under John Eisenberg’s 

outstanding leadership, the agency became exactly what the Institute of Medicine visualized, a central focus, a symbol of national 

commitment for patient safety. It is government at its best, not 

telling doctors how to practice, but providing them the tools they 

need to do better what they want to do. You should be very proud 

of that. I strongly recommend that you assure its future by incorporating it in this legislation as proposed. 

I would like to make one comment about funding. Sixty-million 

dollars sounds like a lot of money. It is not. It is a drop in the 

bucket. Congress has wisely over the years expanded the funding 

for the National Institutes of Health, which we all support and 

which has been responsible for the dramatic advances in science 

over the last 20 years that has so much improved health care. But 

congress has never funded the equally important task of evaluating 

those advances. 

We spend over $25 billion for the National Institutes of Health. 

We should spend at least 5 percent of that on developing the evidence of how those advances work. Five percent would be $1.25 billion a year. That should be the budget for AHRQ, and 20 or 30 percent of that should be earmarked for safety. 

The second part of the legislation which I would like to support 

is the proposal to develop interoperability standards for information technology. Dr. Pardes will address this in more detail, but I 

would like to make several comments. 

The first is that the idea of the computerized patient record has 

been before us in health care for over 40 years. We were talking 

about it when I was in medical school, and yet it has still eluded 

us. The benefits are obvious. For example, if you were taken to an 

emergency room in a hospital in a town 1,000 miles from home, 

they could retrieve your record, in minutes, find out what medications you were taking, what medications you are allergic to, and so 

forth, and give you proper treatment. The computerized record 

would eliminate many of the serious communication barriers that 

are behind many of the errors and injuries that we see in health 

care. It would enable patients and doctors to access their information readily, and I think it would make a tremendous difference. 

It would also provide the data we need for the evidence for evidence-based medicine, again, something we need to move on with. 

We could discover, for example, complications from a new drug 

31

within months, instead of years as at the present time. So, I 

strongly urge you to pass those sections. I think the time has come. 

Clearly, the contentious part of the legislation has to do with the 

protection of voluntary reporting. Since the legislation does not address mandatory reporting, I will not either, but we can talk about 

that if desired. I think that no one questions the need for enhancing voluntary reporting. We all realize that sharing of information, 

learning from one another, is critical for improving safety. 

No reporting system will succeed unless it is safe. Safe means 

that when you report something, you are not at risk for being punished, for being sanctioned or being involved in a malpractice suit. 

At the present time, peer review statutes protect reporting within

hospitals, but that protection is lost when the report leaves the 

hospital walls. This bill addresses that issue and is, I think, appropriate, timely, and necessary. I do not share the concerns that it 

will interfere with the mandatory reporting systems or other reporting systems presently available. 

I do think, however, that section 1182(D)(2) essentially nullifies 

the advantages that the bill provides. Removing protection for disciplinary proceedings is essentially removing protection. No rightthinking physician or nurse will talk about an error they have 

made if that remains in the bill because they will still be at risk. 

So, I think if you leave that in, you might as well not pass the legislation. I urge you to strike section 1182(D)(2). Thank you very 

much. 

[The prepared statement of Dr. Leape follows:]

Statement of Lucian L. Leape, M.D., Adjunct Professor of Health Policy, 

Harvard School of Public Health, Harvard University, Cambridge, Massachusetts 

I wish to lend my strong support for the proposed Amendment to H.R. 4889 offered by Mrs. Johnson, provided it is amended to provide full protection from discovery for voluntarily reported patient safety data. 

Progress in patient safety over the past two years has been astounding. Virtually 

every national organization and all hospitals are changing their practices to reduce 

hazards of patient injury. Many of those efforts have been facilitated by the strong 

leadership provided by the Agency for Healthcare Research and Quality. While 

progress is never as fast as one would wish, injury rates have been reduced, and 

the pace of improvement is accelerating. 

The proposed legislation addresses three important issues related to improving 

patient safety. Two of these, Section 1183, establishing a Center for Patient Safety 

within the Agency for Healthcare Research and Quality (AHRQ), and Section 1184, 

developing interoperability standards for health care information technology systems, are broadly supported; the third, protection for reporting, is more controversial. Let me comment on the easy ones first. 

Center for Patient Safety within the Agency for Healthcare Research and 

Quality (AHRQ)

As I indicated in my testimony to the Senate Committee on Health, Education, 

Labor and Pensions last year, the Agency’s role in advancing patient safety has 

been exemplary. With generous support from Congress, and under the outstanding 

leadership of the late John Eisenberg, AHRQ brought together diverse stakeholders 

to define areas in safety needing further research, disseminate information on 

known safe practices (such as medication safety), provided help for consumers, and 

requested and funded research proposals addressing a broad range of safety questions, including such diverse and important topics as the design and evaluation of 

reporting systems, improvement of medication systems, enhancing collaboration and 

teamwork, and the effect of working conditions on safe performance. It commissioned the National Quality Forum to convene a panel that developed a standard 

list of serious reportable events that states may use in their mandatory reporting 

systems, and an expert panel that will soon release a list of safety practices. 

32

In a very short time, the Agency has become what the IOM called for, and health 

care has desperately needed, both a central focus of activity in safety and a demonstration of a national commitment to safety that facilitates work at the local level, 

in hospitals and health care organizations. This is government at its best: not telling 

doctors and hospitals how to practice, but providing the research, resources and information needed for them to do what they need and want to do, make health care 

safe for all citizens. AHRQ is now the major force for improving patient safety, and 

with continuing support it can become even more useful. You should be very proud 

of this. 

I strongly recommend that the Center for Patient Safety be given your endorsement through the proposed legislation establishing it as a permanent Center within 

AHRQ. 

The initial funding of $50 million provided by Congress in fiscal year 2001 for the 

safety effort at AHRQ not only gave a ‘‘jump start’’ to safety research—over 90 

projects in six areas—it has had another very important effect: it has attracted a 

number of talented researchers and practitioners to work in patient safety. This is 

particularly important at this time because this young field of health care safety has 

only a handful of experts. Developing that expertise, which is analogous to specialty 

training in medicine, will take time, but a good beginning has been made. It is, however, just a start. The number needed is huge: providing just one qualified person 

in each hospital, for example, requires nearly 5000. If the momentum and commitment are to be sustained, funding for the Center for Patient Safety must be increased substantially each year. 

Developing interoperability standards for health care information technology systems

Few technological advances have been so long in coming as the electronic (computerized) patient record. For over 40 years, the prospect of having all of the patient’s 

medical information computerized and, thereby, easily accessed and evaluated by 

those who need to know, has eluded us. A primary barrier has been the lack of 

standards for recording and retaining data that permit exchange between a diverse 

set of computers and data systems. The time has come to sort this mess out and 

move ahead with computerization of patients’ medical records. With proper safeguards, currently available, computerization would enable both patients and their 

doctors to instantly access information, regardless of where they are. The benefits 

in terms of emergency care in far-off places are obvious. Less dramatic, but much 

more common usage will be to facilitate exchange of information between specialists 

and other providers, which has great potential to reduce one of the common cause 

of errors: faulty communication. 

Not only would a standardized electronic medical record vastly improve the efficiency and safety of patient care, the ability to easily and accurately collect large 

volumes of clinical data would vastly accelerate the development of evidence needed 

for the evidence based methods to be disseminated and adopted as wisely specified 

in Section 1185. In addition, with appropriate consent and confidentiality safeguards, the universal record could permit large population testing of new drugs 

within months of their release. Unsuspected side effects could be detected within 

months, instead of years at present, saving thousands of lives. 

I recommend not only passage of section 1184, and Section 3, establishment of a 

Medical Information Technology Advisory Board, but also that Congress provide financial incentives, such as bonuses by CMS, for hospitals that implement computerized patient records. 

Protection of voluntarily reported patient safety data

None of the recommendations from the IOM were as controversial as those for reporting of adverse events. Much of the controversy arose from misunderstandings 

about the nature of mandatory reporting. For many years, a number of states have 

had mandatory reporting systems in which hospitals (not doctors) are required to 

report particularly serious adverse events (not errors). The IOM recommended that 

all states implement such programs, and further recommended standardizing the 

types of events to be reported in order to facilitate aggregation of data for learning 

purposes. AHRQ commissioned the National Quality Forum (NQF) to develop such 

a list of serious reportable events, which it did and published last year. 

The IOM also recommended that voluntary reporting of less serious events be encouraged. Reporting systems can advance patient safety in several ways. First, if incidents are promptly reported, it can serve as an ‘‘early warning system’’ to alert 

all providers of new hazards. The medication error reporting program (MERP) run 

by the US Pharmacopoeia (USP) and the Institute for Safe Medication Practices 

(ISMP) has performed this function for medication errors for years, as does the FDA 

33

MedWatch program for adverse drug reactions. Second, by aggregating large numbers of reports from many institutions, a national reporting system can identify patterns of injury that are not obvious to those at the local level, particularly for rare 

events or those with unusual causes. Third, lessons learned by individual hospitals 

of new methods to prevent errors can be disseminated. Fourth, analysis can lead 

to recommendations for ‘‘best practices’’ for all to follow. 

It is important to recognize that reporting alone does not improve safety. Reports 

must be analyzed and lead to recommendations for changes in care, and those 

changes must be implemented. Analysis of reports is an expensive enterprise, requiring a high level of expertise. It is far more costly than the data entry component 

of a reporting system, yet those costs have rarely been considered when proposals 

are made for a national system. For example, the ASRS run by NASA for aviation 

receives over 30,000 reports annually and costs approximately $70 per case. The annual number of preventable injuries in health care is estimated to be over 1 million. 

A successful national reporting system for health care conducted at a similar level 

of expert analysis as ASRS could cost as much as $70 million per year. 

A more feasible option, which in fact is occurring, is the development of systemwide programs, such as that being developed by NASA for the VA, and specialtybased focused reporting programs, such as those developed by neonatal and adult 

intensivists. Similar programs could be developed by other health care systems and 

specialties. 

No voluntary reporting system will be successful, however, unless reporting is 

safe. Fear of discovery with potential adverse legal consequences is a major inhibitor 

of reporting by hospitals and doctors in all states. Evidence from many sources, 

within and outside of medicine, as well as the accumulated experience of several 

decades, demonstrates that people will not report or discuss information that puts 

them at risk of adverse personal consequences. If we want this information in order 

to learn from our mistakes, we must make it safe for people to report. The proposed 

legislation wisely provides legal protection for information submitted voluntarily to 

patient safety improvement systems. This feature is crucial for the success of all voluntary reporting systems, public or private. 

Unfortunately, in Section 1182 (d) (2) PERMISSIBLE DISCLOSURES, Disciplinary Proceedings, those protections are removed if the information is needed as part 

of a disciplinary procedure. That single clause nullifies all of the benefits of this section. No thinking doctor, nurse or hospital administrator will provide potentially incriminating information to anyone under these circumstances. They will not report. 

Nor should we expect them to. If this clause is retained, this legislation will have 

no impact on reporting. It will not change the status quo. 

Nor is this type of disclosure necessary. Current regulations already mandate reporting of serious adverse events, including the results of investigations carried out 

by hospitals, in many states. Disciplinary proceedings, whether within the hospital 

or conducted by State Medical Boards, are also governed by detailed and tested 

rules that assure fair and full exploration of instances of suspected misconduct. 

State regulatory bodies have many legitimate methods for obtaining information. It 

is only the reports that leave the hospital that need protection. Much of the information is available in other places. The medical record is available, for example, and 

while the individual at risk cannot (rightfully, under our Constitution) be forced to 

testify against himself, other parties have both contractual and legal obligations to 

provide information. That is more than sufficient to meet disciplinary needs. 

I strongly recommend that the Committee delete section 1182 (d) (2). If it remains, the so-called ‘‘protection’’ against discovery will be meaningless.

Wood? 

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

f STATEMENT OF MICHAEL B. WOOD, M.D., PRESIDENT AND 

CHIEF EXECUTIVE OFFICER, MAYO FOUNDATION, ROCHESTER, MINNESOTA, AND MEMBER, HEALTHCARE LEADERSHIP COUNCIL 

Dr. WOOD. Madam Chairman, I appreciate this opportunity to 

speak with you today on a matter of utmost importance to all 

Americans, that is, the level of safety afforded to each and every 

patient who enters our health care system. This Committee is to 

34

be commended for the attention you are giving this vitally important issue. 

I am President and Chief Executive Officer of the Mayo Foundation, based in Rochester, Minnesota. All of us at Mayo are proud 

of our institution’s worldwide reputation for excellence in patient 

care, medical education, and medical research. We are devoted to 

innovation and constant improvement. 

Today, I am testifying on behalf of my colleagues and counterparts who are members of the Healthcare Leadership Council 

(HLC). The Healthcare Leadership Council is a coalition of chief executives of the Nation’s leading health care companies and organizations representing all sectors of health care, from hospitals to 

health plans, from pharmaceutical companies to medical device 

manufacturers. These members are committed to patient safety, 

quality care, and continuous improvement and innovation. 

It is important to note that the health care industry is already 

taking numerous steps to reduce error rates and to continually increase the quality of care we provide for the patients. Many health 

care providers are reducing human error by upgrading systems 

technologies. At Mayo facilities, for example, we are moving toward 

a completely paperless environment, including the computerization 

of patient records for better access, clearer notations, and improved 

care. 

Other Healthcare Leadership Council Member companies are 

also involved in increasing the use of computerized physician order 

entry, computerized on-floor pharmacies, and scanning bar codes at 

the patient’s bedside to reduce the potential for medication errors. 

As well, manufacturers are instituting dose-by-dose packaging, 

improving dosage and interaction instructions, and eliminating 

look-alike packages and product names, all measures well known 

to prevent drug-related accidents. 

Thus, we are seeing the development of a strong public-private 

partnership to enhance patient safety. However, in addition to the 

innovations and improvements that are taking place, patients will 

be well served if Congress adopts measures, such as the bill that 

you have introduced, Madam Chairman, H.R. 4889, the Patient 

Safety Improvement Act of 2002. Legislation such as this will provide a valuable assist to health care providers in conducting the 

kind of information sharing essential to quality improvement. 

In order to achieve widespread and continuous improvements in 

patient safety, there are three directions we must pursue. First, the 

health care industry must work together to develop standards that 

will encourage widespread use of information technology systems. 

You have strongly encouraged this, Madam Chairman, and you are 

absolutely right to do so. This is a priority of ours at Mayo Clinic 

because we know that modern information technology can make 

the patient record more complete, more accurate, and more accessible and reduce the possibility of errors. 

Second, we believe that continued emphasis must be placed on 

voluntary reporting of medical errors and confidentiality protections to encourage sharing of information. To make our health system safer, health providers must be able to collect and analyze patient safety data. We need to avoid punitive measures and an inVerDate jul 14 2003 07:07 Sep 04, 2003 Jkt 086199 PO 00000 Frm 00038 Fmt 6633 Sfmt 6602 E:\HR\OC\86199A.XXX 86199A
35

creased exposure to litigation that would simply drive critically important information underground. 

Your legislation, Madam Chairman, utilizes peer review protections in a very positive way to encourage the development and 

sharing of critical data and especially to bring near-misses out in 

the open for analysis and process improvements before they do 

harm. 

In the discussions we have had thus far today, it is important to 

recognize that the major opportunity to prevent medical errors is 

to identify error-prone processes in health care. Voluntary non-punitive reporting brings these near-misses to light and, conversely, 

mandatory reporting will continue to drive the near-misses into the 

shadows. 

Witness, for example, that in the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Sentinel Events Project 

we have seen reported 2,000 sentinel events in 5 years, whereas 

the MedMARx near-misses voluntary reporting system has brought 

forward 400,000 in 1 year, which represents the major opportunity 

we are seeing. 

Finally, the third area that we need to address is that we must 

adopt safe practice standards that are evidence-based and have the 

flexibility to accommodate evolving science and new medical technologies. It will not serve patients well to use regulatory mandates 

to freeze practices in place today that could well be outdated in 

mere months. 

In closing, I want to again commend this Committee for the energy and attention it is focusing on this important issue. Having 

a hearing like this is conducive to developing the culture of awareness to which I alluded earlier. I am confident that government 

and the health care industry can work together cooperatively and 

constructively to create an environment that encourages constant 

quality improvement. This is an important challenge affecting the 

lives and safety of every American patient and it is a challenge 

that we intend to meet. 

Once again, thank you for the opportunity to share these views 

of the Healthcare Leadership Council. 

[The prepared statement of Dr. Wood follows:]

Statement of Michael B. Wood, M.D., President and Chief Executive Officer, 

Mayo Foundation, Rochester, Minnesota, and Member, Healthcare Leadership Council 

Madam Chairman, I appreciate this opportunity to speak with you today on a 

matter of utmost importance to all Americans, the level of safety afforded to each 

and every patient who enters our health care system. This committee is to be commended for the attention you are giving to this vitally-important issue. 

I am President and Chief Executive Officer of the Mayo Foundation, based in 

Rochester, Minnesota. All of us at Mayo are proud of our institution’s worldwide 

reputation for excellence in clinical practice, education and medical research. We are 

devoted to innovation and constant improvement B principles that we apply intensely to the area of patient safety. 

Today, I am testifying on behalf of my colleagues and counterparts who are members of the Healthcare Leadership Council. The HLC is a coalition of chief executives of the nation’s leading health care companies and organizations representing 

all sectors of health care. We meet on a regular basis to jointly develop policies, 

plans and programs to achieve our vision of a patient-centered 21st century health 

care system. 

It is important that an organization like the HLC be centrally involved in a national discussion on the best ways to improve patient safety. No single health care 

36

sector can act in a vacuum in addressing this issue. Hospitals, medical device manufacturers, health plans, pharmaceutical companies, pharmacies, purchasing companies B all must work in consensus to achieve new advances in patient safety, and 

to ensure that those advances have widespread implementation. 

The HLC is developing this consensus through its Chief Executive Task Force on 

Patient Safety. Through this task force, leaders from all sectors of health care are 

working cooperatively to elevate public confidence in patient safety. We are united 

behind a self-initiated protocol for addressing patient safety positively and responsibly. 

It is important to note that the health care industry is already taking numerous 

steps to reduce error rates and to continually increase the quality of care we provide 

to patients. Many health care providers are reducing human error by upgrading systems technologies. At Mayo facilities, we are moving toward completely paperless 

environments, including the computerization of patient records for better access, 

clearer notations and improved care. 

Other HLC member companies are involved in increased use of computerized physician order entry, computerized on-floor pharmacies, and scanning barcodes at the 

patient’s bedside to reduce the potential for medication errors. As well, manufacturers are instituting dose-by-dose packaging, improving dosage and interaction instructions, and eliminating look-alike packages and product names. 

Many hospitals are voluntarily submitting error data to organizations like the 

Joint Commission on Accreditation of Health Organizations and U.S. Pharmacopia, 

where they receive helpful analysis and feedback on how to avoid similar errors in 

the future. These are just a few of the many examples of activities underway within 

a health care industry that is committed to error reduction and improved safety. 

We are seeing the development of a strong public-private partnership to enhance 

patient safety. In addition to the innovations and improvements taking place in the 

public sector, patients will be well served if Congress adopts measures such as the 

bill you introduced, Madam Chairman, H.R. 4889, the ‘‘Patient Safety Improvement 

Act of 2002.’’ Legislation such as this will provide a valuable assist to health care 

providers in conducting the kind of information sharing essential to quality improvement. The members of the Healthcare Leadership Council stand ready to work with 

you to see this approach become law. 

In my testimony today, I would like to address three points that are absolutely 

critical if we are to significantly reduce medical errors and give all patients the confidence that they will receive care that is safe and of the highest quality. First, we 

must consider the critical role information technology will play in improving patient 

safety. Second, we need to emphasize the importance of confidentiality and voluntary reporting in the handling of errors, so that we can use the knowledge gained 

from medical errors to build better, safer health care systems. And, finally, we need 

to discuss the best methods for developing safe practice standards. 

Information Technology Standards

As I mentioned previously, the Mayo Clinic is moving toward a completely 

paperless environment, including paperless patient records. We have, in fact, completed this process at our Jacksonville, Florida facility. We are doing this because 

we believe the use of information technology can help ensure the completeness of 

the patient record, make it more accessible for all health professionals involved in 

the patient’s care, and reduce the possibility of errors. With an electronic record, 

there is greater assurance that information concerning diagnoses, medication, imminent surgeries and the like is accurate and complete. 

There is no question that information technology has enormous potential to help 

us reduce the possibility of errors, and health care 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 driven by 

sound technologies. Certainly, a voluntary health information infrastructure should 

be encouraged and facilitated as rapidly and as broadly as possible. 

There are challenges in this area for which we must develop solutions. Some hospitals, facing budget constraints, are reluctant to purchase these technologies because of concerns that they cannot be integrated with their current IT systems, or 

because they fear newer, better systems could soon be released which would make 

their major technology investments obsolete. 

The health care industry must work together to develop standards that will encourage widespread usage of information technology systems. HLC is a founding 

member of the National Association of Health Information Technology. Madam 

Chairman, you called upon the industry to act proactively in this area, saying that 

‘‘if you don’t, we will.’’ We take that charge very seriously and, with the creation 

37

of NAHIT, we intend to work toward standards that will maximize the advantages 

technology can bring in reducing medical errors. We also intend to work closely with 

the medical information technology board that H.R. 4889 would create to ensure the 

development and dissemination of best practices in medical information technology. 

Confidentiality and Voluntary Reporting

Our success in improving patient safety will be largely dependent upon the environment we create for handling medical errors and mining the vitally-important 

knowledge that can be gained from those occurrences. We must have a culture of 

awareness, not a culture of blame. 

Health care providers must be able to collect and analyze patient safety data, and 

to use that information to develop better, safer systems. There is a mutual exclusivity between laws that perpetuate litigation and our efforts to transform adverse 

events and ‘‘near mises’’ into permanent and pervasive system improvements. To 

put it simply, an increased likelihood of lawsuits will drive this critically-important 

information underground. The same philosophy applies to the issue of voluntary 

versus mandatory reporting. We must use positive incentives to encourage hospitals 

and providers to swiftly report health care delivery problems. Mandatory reporting 

would be viewed as a punitive effort by the government to extract information from 

private entities B information that could then be used against them in costly litigation. 

Current mandatory reporting programs have been less successful than their supporters envisioned. Compliance with these programs has been inconsistent, due to 

the punitive nature of the programs and ineffective use of the submitted data. Mandatory reporting requirements, and the increased likelihood of punitive results 

against health care professionals and organizations, has effectively suppressed error 

reporting and inhibited open discussion about medical errors. 

Existing voluntary reporting systems, on the other hand, have been successful because of their strong focus on improving practitioner performance instead of punitive results. Examples of successful voluntary systems, such as those from the aviation and motor vehicle industries, show dramatic improvements in reporting levels, 

product design and personnel training. We can learn from these examples that quality improvement requires the design of systems focused on prevention of human 

error rather than on assigning blame. 

Lawmakers must 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. Confidentiality protections should be instituted to 

protect organizations from the fear of litigation that would inhibit and prevent the 

sharing of information. We are pleased, Madam Chairman, to see such peer review 

protections included in your legislation. With this protection, hospitals will be encouraged to share information with organizations that can analyze it to determine 

common error patterns and recommend system improvements. 

To improve patient safety nationwide, we must create this culture of awareness 

nationwide as well. Today, some states have strong peer review protections while 

others do not. These inconsistencies serve as barriers for any patient safety initiatives that involve institutions in multiple states. Moreover, information relating to 

patient safety and ‘‘near-misses’’ may run the risk of losing peer review protection 

when shared outside of an institution. This often creates a greater degree of liability 

exposure than many providers are willing to tolerate. 

Safe Practice Standards

We would all agree that safe practice standards should be in effect to assure the 

highest quality of care for all patients, regardless of the physician or institution 

treating them. We must carefully consider, though, how to develop the most effective standards that will have widespread acceptance and the flexibility to accommodate new innovations in health care. 

We believe that nationally-recognized safe practice standards should be developed 

only through analysis of conclusive data on broad, evidence-based effectiveness and 

feasibility. And these standards must consider evolving science. Additionally, we 

must recognize that not all health care institutions or patient populations are exactly alike and, therefore, health care organizations should be encouraged to adopt 

safe practice programs that are applicable to their unique specialties, patient populations and specific risk points. 

Some have expressed the belief that government should develop and enforce universal standards of care. Rigid government regulations in this arena, we believe, 

would not serve the best interests of patients. Knowledge and innovation in health 

care is constantly evolving, constantly improving. The practices we freeze in place 

today with regulatory mandates could well be outdated in mere months. 

38

It is vitally important that practice standards not stifle scientific innovations. If 

a set of safe practices were to become universally-required standards of care, they 

could effectively establish a ceiling for patient safety practices, and discourage further innovations for even safer practices. While one might argue that national practice standards could be periodically reviewed and updated, the well-known reality 

is that our current regulatory process does not accommodate the kind of rapid and 

substantial changes that new technologies can necessitate. There is also concern 

that government-enforced standards of care may not be feasible for all hospitals and 

health providers throughout the nation. 

There is a commitment on the part of the health care industry to develop safe 

practice standards B standards that are meaningful, feasible and that will encourage, not stifle, future improvements. The Healthcare Leadership Council is an active 

member of the National Quality Forum, and we will continue to work extensively 

to develop workable standards to achieve the best in patient care. 

In closing, I want to again commend this committee for the energy and attention 

it is focusing on this important issue. Having a hearing like this is conducive to developing the culture of awareness to which I alluded earlier. I am confident that 

government and the health care industry can work together cooperatively and constructively to create an environment that encourages constant quality improvement. 

This is an important challenge affecting the lives and safety of every American patient, and it is a challenge that we intend to meet. Once again, thank you for this 

opportunity to share the views of the Healthcare Leadership Council.

Segel? 

Chairman JOHNSON. Thank you very much, Dr. Wood. Mr. 

f STATEMENT OF KENNETH T. SEGEL, DIRECTOR, PITTSBURGH 

REGIONAL HEALTHCARE INITIATIVE, PITTSBURGH, PENNSYLVANIA 

Mr. SEGEL. Chairman Johnson, Congressman Stark, and Members of the Subcommittee, thank you very much for the opportunity 

to testify on the Patient Safety Improvement Act of 2002. 

As brief background to my comments, I want to provide an update on the patient safety activities of the Pittsburgh Regional 

Healthcare Initiative (PRHI), which I direct. The PRHI is a collaborative effort among all of Southwestern Pennsylvania’s major 

stakeholders in health care. Our goal is to establish the world 

benchmark for patient outcomes by identifying and solving problems at the point where patients are cared for. 

We have five major clinical improvement projects and two major 

patient safety projects. We take much of the inspiration for our efforts from Pittsburgh-based Alcoa, which under now-U.S. Department of the Treasury Secretary Paul O’Neill became the world’s 

safest organization. 

We now include 42 hospitals that are working collaboratively to 

eliminate medication errors and nosocomial, or health care acquired, infections. They are all using the same data reporting systems to share learning about these problems, including U.S. 

Pharmacopeia’s MedMARx for medication errors and the Centers 

for Disease Control’s National Nosocomial Infectious Surveillance 

system for infections. In this work, we have received invaluable assistance from critical Federal partners under Secretary Thompson’s 

direction, including the Centers for Disease Control, the Agency for 

Health Care Research and Quality, and the Centers for Medicare 

and Medicaid Services. 

We have seen early signs of progress, including drops in our first 

targeted type of infection, catheter-associated bloodstream infecVerDate jul 14 2003 07:07 Sep 04, 2003 Jkt 086199 PO 00000 Frm 00042 Fmt 6633 Sfmt 6602 E:\HR\OC\86199A.XXX 86199A
39

tions, which have fallen by 22 percent in 1 year. We have also seen 

sharp increases in the number of medication errors reported in our 

community and a reduction in death following cardiac bypass surgery of 14 percent in 1 year. So, we are acting in our community 

to address the concerns identified by the Institute of Medicine and 

by our own community. 

Despite that progress, however, our efforts continue to be slowed, 

sometimes dramatically, by the cautiousness of most hospitals and 

clinicians to share information about errors openly due to fear of 

suit. This fear continues to introduce torturous procedures and cautions into the process of error reporting, analysis, sharing of learning, and improvement. In that context, we believe this legislation 

would promote the more open, honest, and effective reporting and 

analysis of errors that medicine so desperately requires. 

To be most useful to you, I want to use my final minutes to talk 

about some specific components of the bill, because our experience 

tells us that the devil really will be in the details in terms of how 

this legislation is interpreted by the health care legal community 

as well as the courts. 

In terms of patient safety data that is covered, we were very encouraged to see that the legislation does not limit protection to patient safety data collected solely for the purpose of reporting to a . 

This is essential to reflect the real world of health care delivery 

and hospital processes. The inclusion of the word ‘‘solely’’ or an 

equivalent would impose the creation of parallel processes of error 

identification, analysis, and corrective action on institutions. They 

would be left with the present faulty patchwork of peer review law, 

which itself has its own cumbersome restrictions on what happens 

within institutions, as well as providing too little external support 

to deal with error reporting. It would lead to, we fear, less than enthusiastic and complete use of the reporting process contemplated 

here. 

In this regard, we also strongly recommend that you make explicit that the bill’s protections would apply to corrective actions 

taken by a provider internally in response to patient safety data, 

even before waiting for feedback from a . Again, this reflects operating reality and our shared goal for this bill, which is to have errors surfaced and resolved as close to real time as possible, and we 

do not want to make people wait to have to take action in terms 

of feedback coming back. The legislation’s rules of construction 

seem to provide that protection, but we might even make it more 

explicit. 

In terms of the definition of health care provider, we would urge 

you to expand that to include health insurers. They have rich data 

sets that can be sources of information and learning on errors that 

should be explicitly covered. 

We strongly agree with the previous witnesses that the provisions on the interoperability of health care information technology 

systems be enacted. It is a critical step forward, with potentially 

incalculable gains for patient care. 

Finally, on the issue of voluntary or mandatory reporting, this is 

a challenging public policy question. It is one that will be played 

out in Pennsylvania over the next several years as a new mandatory reporting requirement goes into place. I do want to suggest 

40

strongly, based on our own experience and our own interactions 

with the health care systems, that there needs to be a significant 

period of trust building with the health care community via a voluntary non-punitive error reporting system before Congress consider it necessary to enact mandatory reporting provisions. 

If Congress proceeds with a mandatory emphasis right away, it 

will frame the issue in the traditional mode of regulatory compliance played between regulators and providers, and the providers 

have many quills in their arsenal. Within health care institutions, 

I can tell you it will leave implementation firmly in the hands of 

the conservative, cautious lawyers and risk managers that so influence hospital practice in these areas, not uniformly so, but significantly so, and an opportunity to redefine how we think and approach these issues by providing the protection and safety that people need to take action will have been lost. 

So, we strongly support this bill and we hope that its essential 

protections can be enacted into law so that we can move forward 

expeditiously to identify and solve problems quickly. 

[The prepared statement of Mr. Segel follows:]

Statement of Kenneth T. Segel, Director, Pittsburgh Regional Healthcare 

Initiative, Pittsburgh, Pennsylvania 

Chairman Johnson, Congressman Stark and Members of the Subcommittee: 

Thank you for your invitation to comment on H.R. 4889, the Patient Safety Improvement Act of 2002. It was an honor for Karen Wolk Feinstein, Ph.D., Chair of 

PRHI to testify before you on patient safety issues this spring, and we are honored 

to be asked to provide you with our perspective again today. Given the depth and 

sensitivity with which you have examined these issues, the importance of the legislation you have compiled is not a surprise. 

As brief background to my comments, I want to provide an update on the patient 

safety activities of the Pittsburgh Regional Healthcare Initiative (PRHI). 

PRHI is a collaborative effort among all of the region’s major stakeholders in 

health care, including clinicians, hospitals, insurance plans, corporations and smallbusiness purchasing alliances, labor, and even the Attorney General of Pennsylvania. Our goal is to establish the world benchmark for patient outcomes in Southwestern Pennsylvania, by identifying and solving problems ‘‘at the point where patients are cared for.’’ We have five major clinical improvement projects, and two 

major patient safety projects. We take much of the inspiration for our efforts from 

Pittsburgh-based Alcoa, which under now-Treasury Secretary Paul O’Neill, became 

the world’s safest organization. 

PRHI now includes 42 hospitals working collaboratively to eliminate medication 

errors and nosocomial (healthcare acquired) infections. As part of that effort, participating hospitals are all using the same medication error (US Pharmacopeia’s 

MedMARx) and nosocomial infection reporting systems (the Centers for Disease 

Control’s NNIS). In this work, we have received invaluable assistance from critical 

federal partners, including the Centers for Disease Control, the Agency for 

Healthcare Research and Quality, and the Center for Medicare and Medicaid Services. 

We have seen encouraging but early signs of progress, including drops in our first 

targeted type of infection—catheter associated blood stream infections in intensive 

care units—which have fallen by 28% in one year. We have also seen sharp increases in the number of medication errors reported. While Pittsburgh area hospitals constitute roughly 5% of the hospitals using MedMARx nationally, they contribute roughly 10% of the medication error reports. Of course this is encouraging 

news, because the vast majority of medication errors are unreported, and only by 

reporting can they be learned from and other errors prevented. Through our additional collaborative efforts to improve clinical outcomes for patients, we have seen 

a 14% drop in mortality following cardiac bypass operations in one year (between 

1999 and 2000), and are the only region in Pennsylvania with a lower death rate 

than could be expected given the risk-level of our cardiac patients. 40 more cardiac 

bypass patients are alive today because of the work of our cardiac surgery community. 

41

So, we are acting to address the concerns identified by the Institute of Medicine 

and our own community. 

Despite progress, however, our efforts continue to be slowed dramatically by the 

cautiousness of most hospitals and clinicians to share information about errors 

openly due to fear of suit for even the discussion and analysis of errors. This introduces tortuous procedures and cautions into the process of error reporting, analysis, 

sharing of learning, and improvement as a result. 

In that context, we believe H.R. 4889 would promote the more open, honest, and 

effective reporting, and analysis of errors that medicine desperately requires. You 

have modeled your efforts on other high-risk industries such as aviation and nuclear 

power where such approaches have proven to save lives. We hope your colleagues 

in Congress recognize the urgency of echoing these models in health care, where 

lives are being lost every day for lack of such a protected reporting and analysis 

structure. 

To be most useful to you, I want to comment on a few critical aspects of the bill 

as presently structured, and suggest modifications that might strengthen it. As our 

experience ‘‘on the ground’’ has taught us, the devil is in the details of how the critical provisions of this legislation would be interpreted in the courts and by the 

healthcare legal community. 

Patient Safety Data Covered (section 1181(e)(1)(a) and 1181(e)(1)(c))

1) We were very encouraged to see that your legislation does not limit protection 

to patient safety data collected ‘‘solely’’ for the purposes of reporting to a patient 

safety organization, such as other federal legislation has proposed. This is essential 

to reflect the ‘‘real world’’ of healthcare delivery and hospital processes. The inclusion of the word ‘‘solely’’ or an equivalent restriction would impose the creation of 

parallel processes of error identification, analysis and corrective action on institutions. They would be left with the present faulty patchwork of peer review law to 

‘‘protect’’ any internal error reporting and patient safety improvements that were 

not initiated ‘‘solely’’ in relation to a patient safety organization. This would lead 

to less than enthusiastic and complete use of the patient safety organization reporting process. We urge you to stand firm for your ‘‘common sense’’ approach to this 

critical definition. 

2) In this regard, we strongly recommend that you make explicit that the bill’s 

protections would apply to corrective actions taken by a provider internally in response to patient safety data, even before waiting for feedback from a patient safety 

organization. Again, this reflects operating reality. The goal is to have errors surfaced and resolved as close to ‘‘real time’’ as possible. If providers are forced to wait 

for external direction and feedback from a PSO before taking any action on data 

they report in order to enjoy any legal protection regarding the corrective action 

having been taken, we would undermine the likely scale and impact of corrective 

steps. 

This clarification is especially important given the requirements for independence 

of the PSOs. 

Definition of Health Care Provider (1181(d))

3) We recommend that you expand the definition of covered entities to include 

health insurers. Because of their comprehensive data sets, insurers often have rich 

information about errors and error prevention efforts that should be available for 

learning under the protections of this act. Absent explicit inclusion of insurers as 

entities that can report and derive protection under the legislation, this source of 

knowledge will go untapped by the nation. 

Interoperability of Health Care Information Technology Systems (1184)

4) We want to applaud this component of the legislation and urge you to take all 

steps within your power to see that such interoperability standards are established. 

The gains to quality and safety of health care, and efficiency of the healthcare delivery system would be truly enormous. 

Voluntary or Mandatory Reporting

We understand that one of the issues under discussion is whether reporting by 

healthcare organizations under the proposed Act should be voluntary or mandatory. 

This is a challenging public policy question—one that will be played out in Pennsylvania over the next several years due to the passage of legislation requiring reporting of safety incidents within 24 hours of confirmation. But let us suggest that there 

should be years of trust-building with the healthcare community in a voluntary 

error-reporting system before Congress consider mandatory reporting provisions. If 

Congress proceeds with a mandatory requirement right away, it will frame the issue 

in the traditional mode of regulatory compliance played between regulators and proVerDate jul 14 2003 07:07 Sep 04, 2003 Jkt 086199 PO 00000 Frm 00045 Fmt 6633 Sfmt 6621 E:\HR\OC\86199A.XXX 86199A
42

viders, and within healthcare institutions will leave implementation firmly in the 

hands of the conservative, cautious lawyers that so influence hospital practice in 

these areas. An opportunity to redefine how we approach issues of healthcare performance will have been lost. 

In that mode, we would encourage Congress to think boldly in terms of ‘‘carrots’’ 

instead of just sticks to encourage future reporting. 

In conclusion, we applaud your leadership and sensitivity in moving this essential 

legislation. We believe that if its essential protections can be enacted into law, it 

can make a profound impact on the safety, quality and value of healthcare services 

in our community, and the United States.

Chairman JOHNSON. Thank you, Mr. Segel. Dr. Pardes? 

f STATEMENT OF HERBERT PARDES, M.D., PRESIDENT AND 

CHIEF EXECUTIVE OFFICER, NEW YORK-PRESBYTERIAN 

HEALTH CARE SYSTEM, NEW YORK, NEW YORK 

Dr. PARDES. Thank you very much, Chairman Johnson, thank 

you for your leadership both in our own tri-State area and nationally, and thank you, too, Mrs. Thurman, for your leadership. 

It is a wonderful opportunity to address this issue of very great 

seriousness and also to talk about a bill with which I think holds 

great promise to address that issue, the use of information technology to prevent medical errors. 

I am Herbert Pardes. I am a physician and President and Chief 

Executive Officer of New York-Presbyterian. We are the largest 

hospital system in New York State. We also have hospitals in Connecticut, New Jersey, and constitute one of the most comprehensive 

health care institutions in the world. We combined with New York 

Weill Cornell Medical Center and Columbia Presbyterian, and have 

two academic affiliates, the Weill Medical College of Cornell University and Columbia University College of Physicians and Surgeons. 

Our system has some 51 acute care facilities, hospital facilities, 

residential health care facilities, and specialty institutions, more 

than 13,000 affiliated doctors, over 40,000 employees, and annually, over 400,000 inpatient discharges and 3.3 million outpatient 

visits, providing health care to some 5.5 million patients, some 22 

percent of the Greater New York metropolitan region. We are placing a heavy focus, as some of my colleagues articulated, on health 

care quality and also patient services. 

I wanted to focus particularly on the interoperability provisions 

of H.R. 4889 and I want to acknowledge the extraordinary work of 

Members of this House in the area of using information technology 

to protect patient health. First, Mrs. Johnson, who by introducing 

this bill has advanced the cause of safety to a new level. This bill 

is a quantum leap in solving the medical errors problems with tools 

that have not been used effectively in the past and needed someone 

of vision to stand by it. 

Mr. Houghton of New York and Mrs. Thurman of Florida, your 

bill, H.R. 3292, the Medical Errors Reduction Act of 2001, paved 

the way for technology to be applied to patient safety. Your leadership has been central in this field. 

Mr. Rangel, too, of New York, has understood and supported the 

notion that a new solution based on technology must be applied to 

health care for us to solve the old problems that have bedeviled us. 

43

So, thank you all for your leadership. Thank you, too, Mr. Stark, 

for your leadership and concern about the needs of patients and the 

best interests of health care. 

Patients suffer for lack of standards that would allow computer 

systems to exchange and process information across different vendor and specialty platforms. The lack of standards has been a huge 

barrier to the wise and widespread use of technology to prevent 

medical errors. In the vast majority of health care settings, a great 

deal of disparate information is collected on a patient, but the information is not presented to a clinician in a single computer 

screen. So, the data is only coordinated for the care of that patient 

when a clinician reviews it, usually when it is brought together on 

paper. If a result does not make it to the paper record, the clinician 

often is not aware of it when she makes her care decisions. 

We feel there should be one computerized view of this information. Without adequate investment in elaborate interface technologies, different vendor systems cannot share all of the information. Standards would help obviate that need. Without standards, 

hospitals can never be sure of their investment in new technology. 

Will the existing systems work with new ones? Will new systems 

block the purchase of yet other equipment from different vendors? 

Hospitals do not have the capital to revisit major information 

technology purchases on a year-after-year basis. While American 

industry generally spends between 7 and 10 percent of its revenues 

on information technology, health care, with its marginal economics, spends less than 3 percent. 

In its interoperability provisions, the bill wisely creates the Medical Information Technology Advisory Board, to ensure that producers and consumers of health information, as well as those who 

provide the tools for collecting, storing, and exchanging this information, are part of the development process. The legislation should 

seek to support the real world application of these information 

technology standards by testing them in real patient care settings. 

H.R. 4889 actualizes the potential of information technology in 

health care. Through an inclusive process that calls upon the expertise of industry, academic medicine, community medicine, public 

health, and government, the formation of the Medical Information 

Technology Advisory Board, which is thereby suggested or put 

forth, is necessary so interoperability solutions can be found that 

are applicable in the greatest number of health care settings, 

whether government or private. 

Those who use information technology and those who manufacture it must be aligned from the beginning to design the right solutions. We have seen too often in the past how good technology fails 

because what has been designed for one environment does not necessarily translate into another. For example, excellent systems for 

administrative data exchange do not necessarily translate well for 

clinical care. 

This bill coalesces those who produce health care data, those who 

consume it, and those who make the technology of storage and exchange around a single effort. There is one step, however, that is 

at least as important which is yet to be included in the legislation. 

H.R. 4889 needs to recognize that what happens at a theoretical 

level may not translate well into an operational environment, parVerDate jul 14 2003 07:07 Sep 04, 2003 Jkt 086199 PO 00000 Frm 00047 Fmt 6633 Sfmt 6602 E:\HR\OC\86199A.XXX 86199A
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ticularly in a field as complex as health care. For the vision of H.R. 

4889 to be realized, we believe it is critical that demonstration 

projects to test the efficacy, use ability and scalability of information technology standards be conducted. 

Scalability is a key determinant of success. A technology that appears to be a great idea in the inventor’s garage and works beautifully in a dozen physicians’ offices can fail when it has to care for 

millions of patients. Medicare and Medicaid’s patients are found in 

every setting in America, large inner cities, sparse rural counties, 

suburban tracts, and local neighborhoods, so standards must be 

tested in a diversity of settings to ensure they will work wherever 

these patients and all Americans receive their care. 

I urge you to add that support for demonstration projects to the 

legislation and I congratulate you again for this far-sighted solution. Most of all, I thank you for acting to solve what we feel is a 

most knotty problem, not with yesterday’s thinking, but with tomorrow’s technology, today’s resolve, and a commitment to do 

something concrete and necessary for the best health interests of 

the American people. Thank you. 

[The prepared statement of Dr. Pardes follows:]

Statement of Herbert Pardes, M.D., President and Chief Executive Officer, 

New York-Presbyterian Health Care System, New York, New York 

Summary

• New York-Presbyterian Hospital is one of the nation’s largest academic 

medical centers and is a center of excellence in the use of information technology (IT). 

• IT in the clinical setting can reduce medical errors and increase quality of 

care through a wise national investment policy. The Computer-based Patient Record (CPR) is at the center of a technology strategy that would reduce errors. A complete CPR is impossible without standards for interoperability in healthcare IT. 

• Hospitals are functioning at or below margin and are hard pressed to pursue the necessary investments to establish appropriate systems. 

• Two major steps are needed: a standard setting process to allow interoperability among diverse systems from different vendors; and federal reimbursement. Academic medical centers have the expertise and neutrality to 

lead this process in collaboration with industry and government. 

• The interoperability provisions of H.R. 4889 advance the right approach. 

They call for the formation of a board of experts from every effected constituency to recognize existing standards and develop or validate new 

standards. However, another step is also needed. Congress needs to allow 

for the demonstration projects that will assure the efficacy, usability and 

scalability of standards. As technology is developed for millions of patients 

rather than thousands, or even tens of thousands, scalability becomes a 

major stumbling block.

New York Presbyterian Hospital

New York-Presbyterian Hospital (NYP) is the largest hospital system in New 

York State and one of the most comprehensive healthcare institutions in the world. 

NYP represents a combination of two of the world’s greatest medical resources, New 

York Weill Cornell Medical Center and Columbia Presbyterian Medical Center with 

their academic affiliates, the Weill Medical College of Cornell University and Columbia University College of Physicians & Surgeons. The NYP Health Care System 

(HCS) has a total of 51 acute care hospital facilities, residential health care facilities 

and specialty institutions, more than 13,000 affiliated doctors, over 40,000 employees, and annually over 400,000 inpatient discharges and 3.3 million outpatient visits 

providing healthcare to 5.5 million patients—22 percent of the greater New York 

metropolitan region. The Hospital and its affiliated institutions and medical schools 

are engaged in a large number of medical research projects and receive about $300 

million in research funding annually. 

45

NYP is the home of the Columbia University Department of Medical Informatics, 

which traces it roots to a 1981 National Library of Medicine (NLM) Integrated Academic Information Management System (IAIMS) initiative. The planning and prototype phases of that initiative led to the creation of the Center for Medical 

Informatics in 1987. In 1994, Columbia University made the Center a full-fledged 

department in the health sciences campus, with the same rights and responsibilities 

as other departments such as Medicine and Surgery. 

Since the beginning, the Department’s focus has been on research, teaching, and 

service. A phase III IAIMS grant and an IBM contract funded the development of 

the next generation Clinical Information System (CIS). CIS has served as the Department’s living laboratory for medical informatics research, as a training ground 

for new informatics researchers, and as New York-Presbyterian Hospital’s clinical 

system. The system is used by 95% of attending physicians and essentially all residents and fellows. It currently has 4000 unique users per month, and there are 2 

million patients in the database. 

Information Technology and Medical Errors

Computers have great promise in healthcare as tools for monitoring patient care 

to the most minute detail. According to the IOM, ‘‘The majority of medical errors 

do not result from individual recklessness but from basic flaws in the way the 

health system is organized—illegible writing in medical records has resulted in administration of a drug for which the patient has a known allergy—And the health 

care system itself is evolving so quickly that it often lacks coordination. For example, when a patient is treated by several practitioners, they often do not have complete information about the medicines prescribed or the patient’s illnesses.’’ In short, 

even highly competent physicians can be stymied by a system that makes timely 

access to accurate and legible information difficult. 

Clinicians are very good at giving care. Information systems are very good at process. The errors described in the IOM report were seldom errors of judgment; they 

were mistakes in process. The man who had the wrong leg amputated; the woman 

who died from an overdose of chemotherapy; the child with the fatal allergy to anesthesia—if only the clinicians had been aware of that one missing vital piece of information, they would have known the right thing to do. In many industries, computers track such crucial information. 

If all pertinent patient information were made rapidly and seamlessly available 

to doctors when they needed it, clinicians who are trained to use their judgment 

based on the available facts would be in a better position to make optimal decisions. 

Does the patient have an allergy to anesthesia? The system would automatically 

alert the anesthesiologist if an inappropriate drug is prescribed. On which breast 

does the mammography report identify a tumor? The system automatically generates a diagram on the computer’s display to verify the location. Does the clinician 

administer an excessive dosage of medicine because she has misread the prescription? The system compares the dosage with information about the patient’s condition and alerts the clinician when the dosage is out of range. 

And thanks to the World Wide Web, the benefits of this technology are not limited 

to large academic medical centers. We have recently seen the introduction of technologies that can monitor patients at great distances over the Web. From the home 

or in other settings, patient data are analyzed before being passed on to clinicians, 

alerting them to changes that need attention and storing information for future reference. 

One branch of medical informatics, the science underlying the development of information systems to improve health care and other areas of biomedicine, is called 

automated medical decision support. It has been studied for more than 20 years at 

leading institutions across the nation. In fact, the standard computer language for 

generating computer-based medical warnings and reminders is the Arden Syntax, 

developed in part by researchers at Columbia University’s Department of Medical 

Informatics located at the New York-Presbyterian Hospital. 

Yet, developing an integrated technology that meets all the needs of American 

health care will require research and development support. Transferring the technology to hospitals most in need will require additional funding support. Leading 

health care institutions have the expertise to develop these Clinical Information 

Systems, but not the funding. 

A wise national policy for healthcare Information Technology (IT) should target 

resources and expertise to increase the application of IT to reduce medical errors 

and improve health care quality. The Institute of Medicine suggests that at least 

44,000 patients, and as many as 98,000, die each year as a result of medical errors. 

Data on medication errors show that 2.8 percent of all hospitalized patients experience a preventable adverse drug event, resulting in increased morbidity and morVerDate jul 14 2003 07:07 Sep 04, 2003 Jkt 086199 PO 00000 Frm 00049 Fmt 6633 Sfmt 6621 E:\HR\OC\86199A.XXX 86199A
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tality as well as significant added cost to the healthcare system. The cost of preventable medication errors alone is estimated at $2 billion annually. Emerging technologies to reduce medication errors at the stage of both ordering and administration hold significant promise, particularly if they are able to coordinate all information from the patient’s medical record. Technologies such as the Computer-based Patient Record (CPR) and secure Web-based communication with patients can enhance 

the coordination of care, support implementation of evidence-based practice and engage patients more fully as partners in their medical treatment. It makes sense to 

focus efforts on the CPR, which lies at the center of a comprehensive hospital IT 

system, rather than on any single element of the system. For example, a stand-alone 

Computerized Physician Order Entry system (CPOE) will not attain the Institute 

of Medicine’s goal of a 50 percent reduction in preventable medical errors by 2005, 

according to the Stamford, Connecticut.-based Gartner Group’s top ten list of IT 

issues confronting healthcare professionals. A CPOE system that is part of a CPR 

system linked to clinical alerts and decision support will be the means to secure that 

objective. 

In fact, a broad-based national IT policy would address some of the most difficult 

problems in medicine in addition to preventing medical errors, including epidemiological data tracking to fight bioterrorism. It would ensure that patients receive the 

best care no matter where they live or travel. It would take advantage of the great 

global infrastructure—the Internet—and so be broadly available. It would 

incentivise industry—insurers, systems manufacturers and software companies—to 

participate in standards development. 

Barriers to Bringing IT to Hospitals

Health care lags behind almost every other major industry segment in investment 

in Information Technology. Average IT spending per employee per year among all 

U.S. industries is about $6,900 per year. The banking segment spends almost 

$15,000 per employee on IT. The insurance industry spends more than $13,000 per 

employee and telecommunications clocks-in at more than $11,000 per employee. 

Health care invests only about $3,000 per employee per year on IT. Another way 

of casting this is that other industries spend from 7–10% of revenues on IT; 

healthcare is below 3%. 

Yet Clinical Information Services can vastly improve the quality of health care 

with long-term benefits for overall costs. And it would be centered on the concept 

of the computerized patient record (CPR). 

A computerized patient record would carry a patient’s entire medical history and 

related information in a secure, privacy-protecting, Web-accessible database. There 

are three barriers to implementation of a national health information system policy.

• There is no standard platform technology or terminology for the CPR as 

there is for business and other applications; • There is insufficient investment and financial incentive, by the government 

and the private sector; and • There is insufficient leadership

The issue of standards, in particular, has been a huge barrier to the wise and 

widespread use of technology to prevent medical errors. In the vast majority of 

healthcare settings, a great deal of disparate information is collected on a patient 

but that information is not presented to a clinician on a single computer screen. 

Thus, the data is only coordinated for the care of that patient when a clinician reviews it, usually when it is brought together on paper. If a result doesn’t make it 

to the paper record at the right time, the clinician will not be aware of it when she 

makes care decisions. Thus, there needs to be one computerized view of this information. This requires a large investment in elaborate interface technologies because 

different vendor systems can’t automatically share all of the information with each 

other. Standards would obviate that need. Without standards, hospitals can never 

be sure of their investment in new technology. With standards, hospitals will be encouraged to invest in IT, knowing they will have a stable platform. 

The solutions to these problems are within grasp. The Federal Government has 

a clearly definable role in creating solutions that will deliver to Americans the errorreduction promise of the CPR without being intrusive to care providers or the industries that support them. 

These things must be done for an effective National Health Information System 

Policy to be accepted by health care providers, insurers and CIS manufacturers.

• Before standards that support interoperability can be promulgated or driven by market demand, they must be developed. There is room for much 

flexibility in such formats, as described in the IOM study For the Record. 

Standard setting efforts have been successful in creating protocols for transVerDate jul 14 2003 07:07 Sep 04, 2003 Jkt 086199 PO 00000 Frm 00050 Fmt 6633 Sfmt 6621 E:\HR\OC\86199A.XXX 86199A
47

mitting health data. One example is Health Level 7 (HL–7), a protocol for 

transmitting health information that provides a solution to one of the many 

issues in interoperability of healthcare IT. HL–7 was supported by academic medical institutions for years in the face of industry skepticism. As 

more institutions adopted HL–7, the industry realized the advantage of 

being able to design to a standard and embraced it most profitably. The 

most important thing is to be able to securely share patient information 

among different caregivers and researchers. The Government should support research and development for standards by credible institutions 

through a demonstration process led by centers of excellence in academic 

medicine, with full collaboration by industry. • CPR standards must aid hospitals in complying with HIPAA, the Health 

Information Portability and Accountability Act. HIPAA rightly mandates 

extreme care of confidential patient data. But its enactment has been stymied by a hodgepodge of competing interests and its implementation promises to be one of the largest unfunded mandates ever levied on the health 

care industry. A wise national health information system policy will create 

standards for easier, more affordable compliance. • Medicare and Medicaid should include incentives for hospitals to comply 

with the standards of the National Health Information System Policy, and 

provide disincentives for noncompliance. It’s cheaper to process an electronic transaction than a paper one—that’s why banks used to reward customers to use ATMs instead of tellers. The Center for Medicare and Medicaid Services (CMS) has, in the past, viewed technology as a cost-center 

rather than an investment. Yet a CPR can reduce difficulty in a variety of 

reporting and compliance areas. Medicare can reap the same benefits from 

technology that private sector industries have, increasing productivity and 

quality through the strategic use of IT. The Information Technology Association of America projects that an industry-wide investment in IT of $18.1 

billion would yield gross savings of greater than $120 billion dollars for the 

healthcare industry over a six-year period. But unlike other industries, 

healthcare providers do not have the profit margins to invest for the future 

in this area. • The Federal Government should provide funding to help hospitals invest in 

IT. Hospitals and academic medical centers are at the center of an integrated health IT system and will be among the greatest users of the technology. But they cannot alone shoulder the cost of developing a system that 

must be able to serve patients, doctors, government agencies and insurers. 

Clearly there is justification for a national investment in the development 

of such a system. In fact, a nationally functional system will only be built 

collaboratively. The system will be potentially useful for those areas of increasing shortage in health care providers—rural areas and the inner city. 

Support is given in a variety of underserved locales for aspects of care.

The Patient Safety Improvement Act Of 2002

H.R. 4889, The Patient Safety Improvement Act Of 2002, contains provisions on 

interoperability of healthcare IT that will allow information technology to fulfill its 

promise in the area of patient safety. I want to acknowledge the extraordinary work 

of several Members of the House in the area of using IT to protect patient health. 

First Chairwoman Johnson, who by introducing this bill has advanced the cause of 

safety to a new level. This bill is a quantum leap in solving the medical errors problem with tools that have not been used effectively in the past and needed someone 

of vision to champion it. Mr. Houghton of New York and Ms. Thurman of Florida, 

your bill H.R. 3292, the Medication Errors Reduction Act of 2001, paved the way 

for technology to be applied to patient safety. Your leadership has been sine qua non in this field. Mr. Rangel of New York has long understood that a new solution 

based on technology must be applied to healthcare for us to solve the old problems 

that have bedeviled us. Thank you also for your leadership and support of the interoperability provisions. 

How does H.R. 4889 actualize the potential of IT in healthcare? The bill establishes an inclusive process that calls upon the expertise of industry, academic medicine, community medicine, public health and government. The formation of the Medical Information Technology Advisory Board (MITAB) is necessary so that interoperability solutions can be found that are applicable in the greatest number of 

healthcare settings, whether government or private. Those who use IT and those 

who manufacture it must be aligned from the beginning to design the right solutions. We have seen too often in the past how good technology fails because what 

has been designed for one environment does not translate to another. For example, 

48

excellent systems for administrative data exchange do not translate well for clinical 

care. The MITAB section of the bill would bring together those who produce 

healthcare data, those who consume it and those who make the media of storage 

and exchange around a single effort. 

However, there is a step that is at least as important, which has yet to be included in this legislation. H.R. 4889 needs to recognize that what happens at a theoretical level may not translate well into an operational environment, particularly in 

a field as complex as healthcare. For the vision of H.R. 4889 to be realized, it is 

critical that demonstration projects to test the efficacy, usability and scalability of 

IT standards be conducted. Scalability is a key determinant of success. A technology 

that appears to be a great idea in the inventor’s garage, and works beautifully in 

a dozen physician offices, can fail when it has to care for millions of patients. Medicare and Medicaid’s patients are found in every setting in America, large inner cities, sparse rural counties, suburban tracts and local neighborhoods. So standards 

must be tested in a diversity of settings to ensure they will work wherever these 

patients, and all Americans, receive their care. 

Congress has an opportunity rarely presented in history. It can instigate a paradigm shift by seizing today’s revolutionary technology, and it can save lives by putting it in the hands of the nation’s healers. It is time to convene the best minds 

in this field and develop the standards for technology that will be indispensable to 

our future health. Academic medical centers can collectively take the lead in developing the technology for patient and clinician needs, and billing and compliance requirements. But they must be part of a vigorous partnership with the government, 

physician organizations, insurers and corporations—all of which will benefit from a 

true national IT system.

Rosenthal? 

Chairman JOHNSON. Thank you very much, Dr. Pardes. Ms. 

f STATEMENT OF JILL ROSENTHAL, MPH, PROJECT MANAGER, 

NATIONAL ACADEMY FOR STATE HEALTH POLICY, PORTLAND, MAINE 

Ms. ROSENTHAL. Thank you, Chairwoman Johnson, Congressman Stark, and Members of the Committee. My name is Jill Rosenthal and I am with the National Academy for State Health Policy, 

a nonpartisan, nonprofit public policy research organization that 

works with State governments to help them achieve excellence in 

health care policy and practice. Our organization has been working 

with the Institute of Medicine and States on the issue of patient 

safety since 1999. 

Among the recommendations outlined in the IOM report, ‘‘To Err 

Is Human,’’ is the call for two types of reporting systems, each designed to address a specific concern, mandatory reporting as part 

of a public system for holding health care organizations accountable for performance, and voluntary reporting to complement mandatory reporting by detecting system weaknesses before serious 

harm occurs. The IOM made clear there is the need for both mandatory public reporting and voluntary, confidential reporting. 

As the IOM envisioned, a nationwide mandatory reporting system would be established by building on current State systems 

with funding provided to States for this purpose. States would be 

given this role because they are on the front line in protecting the 

public’s health. States have the unique role and legal responsibility 

to license and provide oversight of health care facilities and professionals. The public looks to State government to ensure that the 

health care system takes measures to ensure care is safe. 

Although States have struggled with lack of resources to implement reporting systems, they are embracing the challenge. Twenty 

49

States have created mandatory reporting systems. More States are 

considering them and others would follow if resources were available. 

According to State officials, mandatory systems play a vital role 

in facility oversight and provide a window into facility patient safety practices. In addition to investigating individual events and ensuring corrective action, many States share reported information 

with professional licensure boards when professional standards 

may have been violated and issue patient safety alerts and newsletters to help facilities improve safe practices. Unfortunately, this 

bill will likely interfere with States’ capacity to meet their obligations. 

Here is where the bill creates problems. The bill does not recognize the importance of separate reporting systems for accountability and learning. Without a mandatory system that provides accountability, there will be no check and balance and Congress and 

the public will have no way to know that voluntary reporting is reducing serious medical errors. 

The bill does not distinguish between the purpose of collecting information about medical errors that result in serious harm and 

those that result in minimal harm. Voluntary systems are intended 

for events that cause minimal harm. Events that cause serious 

harm are intended for mandatory systems because these types of 

events may indicate serious system weaknesses. However, the bill 

defines patient safety so broadly that it applies to all events. As a 

result, the bill creates an additional burden on providers who may 

have to report the same events to two systems. 

The bill does not recognize or support the State’s role in ensuring 

accountability through mandatory systems. The bill could have a 

chilling effect on State efforts to collect data for the purposes of accountability. If duplication exists, providers are unlikely to support 

two separate reporting mechanisms and will likely lobby against 

State efforts to create mandatory systems, even though they have 

a different scope, purpose, and function. The bill authorizes funding 

for voluntary reporting but does not address the IOM recommendation to fund State-based mandatory systems. 

The bill’s confidentiality provisions may conflict with State reporting system provisions. The bill requires data reported to Patient Safety Organizations to be confidential and privileged. However, the IOM report recommended that analysis of individual serious events be made available to the public as part of a system of 

accountability. Since the bill requires reporting of all types of 

events, all events would fall under strict confidentiality protections. 

In a later study, the IOM called for the health systems to be accountable to the public, to do their work openly, to make their results known to the public and to build trust through disclosure, 

even of the system’s own problems. According to the IOM, a transparent health care system will improve trust and be more patientcentered and safer because patients would have information to 

make informed decisions about their care. 

There are opportunities to improve the bill to meet the IOM’s intent and eliminate some of the problems for States. One, clarify the 

scope, purpose, and function of voluntary reporting as separate 

from and complementary to State-based mandatory systems. 

50

Two, recognize that State-based mandatory systems focus on 

cases that cause serious harm and may make information known 

to the public. Events that cause serious harm, death, and criminal 

events should not be given legal protection under a voluntary system. 

Three, balance funding for improving national voluntary reporting with funding for State-based mandatory systems. 

In closing, State and Federal Government need to represent consumers and assure them that the health care system is being held 

accountable for safety. A public reporting system that provides both 

a check and balance and public information is needed, as is a voluntary system for quality improvement. Without both, we cannot 

realize the IOM’s goals and we fail to provide needed public accountability for patient safety. Thank you. 

[The prepared statement of Ms. Rosenthal follows:]

Statement of Jill Rosenthal, MPH, Project Manager, National Academy for 

State Health Policy, Portland, Maine 

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

My name is Jill Rosenthal and I am a project manager for the National Academy 

for State Health Policy, a non-partisan, non-profit public policy research organization that works with state governments to help them achieve excellence in their 

health care policy and practice. 

Our organization has been working with the Institute of Medicine and states on 

the issue of patient safety since 1999. We have provided policy analysis, training, 

and technical assistance to states as they have attempted to address the Institute 

of Medicine’s recommendations. 

Among the recommendations outlined in the Institute of Medicine report To Err 

is Human is a call for two types of reporting systems, each designed to address a 

specific concern. Mandatory reporting was intended for events that cause serious 

harm or death, as part of a public system for holding health care organizations accountable for performance. Voluntary reporting was intended to complement mandatory reporting by detecting system weaknesses before the occurrence of serious 

harm. The Institute of Medicine made clear that there is a need for both mandatory, 

public reporting systems and voluntary, confidential reporting systems. 

As envisioned by the Institute of Medicine, a nationwide mandatory reporting system should be established by building on current state systems. The IOM recommended that funding be provided to states for this purpose. 

States are the appropriate entities to take on this role because they are on the 

front line in protecting the public’s health. States have the unique role and legal 

responsibility to license and provide oversight of health care facilities and professionals. The public looks to state government to ensure that the healthcare system 

takes necessary measures to ensure care is safe. 

Although states have struggled with a lack of resources to implement reporting 

systems, they are embracing the challenge. Today 20 states have created mandatory 

reporting systems. More states are considering enacting systems and others would 

follow if resources were available. 

According to state officials, mandatory reporting systems play a vital role in hospital oversight by providing a window into hospital patient safety practices and developing more complete facility profiles. In addition to investigating individual 

events and ensuring corrective action, many states share reported information with 

professional licensure boards when professional standards may have been violated, 

and they issue safety alerts and newsletters to help facilities improve safe practices. 

Examples:

• Colorado shares copies of some incident reports with professional licensing 

boards, the attorney general’s office, and other relevant state agencies. 

• Tennessee reviews corrective action plans while investigating complaints 

and during annual surveys to ensure that facilities have carried out their 

plans. 

• In Kansas, surveyors are given a summary of all adverse findings for each 

facility. During surveys they examine facility risk management and assure 

51

that corrective actions have been implemented and if additional problems 

are noted, that further corrective actions are taken. • Massachusetts provides data to the Massachusetts Coalition for the Prevention of Medical Errors to determine approaches for alerting and informing 

facilities about the risk of errors and practices for addressing identified 

problems. • New York’s system includes a report generation function that allows facilities to track and trend their own incidents and to compare their performance against peer facilities, within their regions, and statewide.

States continually strive to improve their systems. We are currently working with 

states and the National Quality Forum to compare state lists of types of events with 

the National Quality Forum’s (NQF) list of Serious Reportable Events in order to 

help states develop a standardized list of clearly defined events that can be easily 

implemented and that allows room for state flexibility. 

Unfortunately, the bill before you will likely interfere with states’ capacity to meet 

their obligations. 

Here’s where this bill creates problems: 

The bill does not recognize the importance of establishing separate reporting systems for accountability and learning.

Without a mandatory system that provides accountability, there will be no check 

and balance and Congress and the public will have no mechanism to know that voluntary reporting is working to reduce serious medical errors.

The bill does not distinguish between the purpose of collecting information about medical errors that result in serious harm and those that result 

in minimal or no harm.

Voluntary reporting systems are intended to collect information about events that 

cause minimal or no patient harm. Events that cause serious harm or death are intended for mandatory systems because these types of events may indicate serious 

system weaknesses. However, ‘‘patient safety data’’ is so broadly defined in the bill 

that it applies to all types of events. As a result, the bill creates an additional burden on providers who may be required to report the same events to both state-based 

mandatory systems and the national voluntary system.

The bill does not recognize or support the states’ role of ensuring accountability through mandatory reporting systems.

The bill could have a chilling effect on state efforts to collect data for purposes 

of accountability. If duplication exists, providers will be unlikely to support two separate reporting mechanisms and will likely lobby against state efforts to create mandatory reporting systems even though they have a different scope, purpose, and 

function than voluntary systems. The bill authorizes funding for the voluntary system but does not address the IOM recommendation to fund state-based mandatory 

systems.

The bill’s confidentiality provisions may conflict with state reporting system provisions.

The bill requires data reported to patient safety organizations to be confidential 

and privileged. However, the IOM recommended that analyses of individual serious 

event reports should be made available to the public as part of a public system of 

accountability. Since the bill requires reporting of serious events in addition to those 

that cause minimal harm, all events would fall under strict confidentiality protections. 

In a later study, the IOM called for health systems to be accountable to the public; to do their work openly; to make their results known to the public and professionals; and to build trust through disclosure, even of the systems’ own problems. 

According to the IOM, a transparent health care system will improve trust, be more 

patient-centered, and safer, because patients would have information to make informed decisions about their care. Some organizations, such as the Veteran’s Administration, have increased transparency already. The IOM points out that although 

many providers fear increased transparency could increase liability, some evidence 

shows that open disclosure of errors may decrease the likelihood of malpractice loss. 

There are opportunities to improve the bill that would meet IOM’s intent 

and eliminate some of the problems for states:

1. Clarify the scope, purpose, and function of voluntary reporting systems as 

separate and distinct from, and complementary to, state-based mandatory 

reporting systems. This would reduce duplication and confusion and lay 

the groundwork to address IOM recommendations. Confidential, voluntary 

52

reporting systems should not preempt state public mandatory systems that 

collect information about events that cause death or serious harm in the 

20 states with existing systems or in states that have yet to develop mandatory systems. 

2. Recognize the role of state-based mandatory reporting systems as identified in the IOM report: to collect information on specific cases that cause 

serious harm or death for the purpose of accountability and to collect information that may become known to the public. Certain events, such as 

those that cause serious harm, death, and criminal events, should not inadvertently or intentionally be given legal protection under a voluntary 

system. 

3. Balance funding for improvement of national voluntary reporting efforts 

with funding for state-based mandatory systems, as envisioned by the IOM 

report.

State and federal government need to represent consumers and assure them that 

the health care system is being held accountable for safety. A public reporting system that provides both a check and balance and public information is needed as is 

a voluntary system for quality improvement purposes. Without both, we cannot realize the Institute of Medicine’s goals and we fail to provide needed public accountability for patient safety. 

Background 

The National Academy for State Health Policy 

National Academy for State Health Policy is a non-partisan, non-profit public policy research organization that works with state governments to help them achieve 

excellence in their health care policy and practice. Since its inception in 1987, 

NASHP has provided state health policy leaders with access to timely, unbiased information on pressing healthcare issues. Because NASHP recognizes that responsibility for health care does not reside in a single state agency, department, or branch 

of government, it strives to foster productive interchange across all lines of authority. Each year, NASHP conducts policy analysis, provides training and technical assistance to states, and—through its publications, annual state health policy conference, media briefings, meetings, and website (www.nashp.org)—disseminates information designed to assist states in the development of practical, innovative solutions to complex health policy issues. 

States with mandatory reporting 

Twenty states have created mandatory reporting systems:

California Nebraska South Carolina

Colorado Nevada South Dakota

Connecticut New Jersey Tennessee

Florida New York Texas

Kansas Ohio Utah

Maine Pennsylvania Washington

Massachusetts Rhode Island 

Information that states collect 

Twenty state licensure and certification agencies require mandatory reporting of 

adverse events that occur in hospitals. Many of the reporting systems also collect 

information from ambulatory care centers and psychiatric hospitals. Some collect information from free-standing laboratories and outpatient mental health centers, 

nursing facilities, and other licensed facilities. For example, Colorado’s reporting 

system requires reporting from general and acute care hospitals, ambulatory care 

centers, psychiatric hospitals, freestanding laboratories, freestanding outpatient 

mental health centers, nursing facilities, and other licensed facilities. Washington 

State’s reporting system collects information from acute care hospitals only. 

States identify and define reportable events in different ways although they require fairly similar data elements to be reported. Facility name, type of incident, 

and date of occurrence are required by all states. Most states also include patient 

identification, provider identification, description of the incident, person reporting 

53

the incident, action taken by facility, patient outcome/status, and notification of 

other parties (e.g. professional licensing boards). Some include identification of witnesses as well. 

Standardizing elements within state reporting systems 

One of the barriers that states face in implementing mandatory reporting systems 

is identifying an unambiguous and clearly defined list of reportable events. The IOM 

report called for a nationwide mandatory reporting system that provides for the collection of standardized information by state governments about adverse events that 

result in death or serious harm. The report urged Congress to designate the National Quality Forum (NQF) as the entity responsible for establishing and maintaining a core set of reporting standards to be used by the states. Through its Serious 

Reportable Events Project, the NQF used a voluntary consensus standards setting 

process to develop a set of serious, preventable adverse events that might form the 

basis for a national state-based event reporting system. Participants identified 27 

serious adverse events that should be reported by all licensed healthcare facilities. 

As suggested in NQF’s report, additional specification may need to be developed to 

ensure standardized data collection. 

The National Academy for State Health Policy (NASHP) is working with the NQF 

and a group of states (SAFER: State Alliance for Error Reporting) to compare state 

lists of reportable events with the National Quality Forum’s (NQF) list of Serious 

Reportable Events in order to determine areas of overlap and areas of difference. 

The result of the project will be a user’s guide to help states develop a standardized 

list of clearly defined events that can be easily implemented and that allows room 

for state flexibility. 

States considering mandatory reporting 

Twelve bills dealing with some aspect of error reporting were introduced in seven 

states during the 2001 state legislative sessions. Of these, six bills (in MA, MD, NY, 

and PA) would require new types of mandatory reporting or would strengthen existing reporting requirements. 

State protection and disclosure of data 

The IOM recommended that errors that are identified through mandatory reporting systems and are part of a public system of accountability should not be protected 

from discovery. State investigations of individual incidents are available on request 

in most states. One state makes investigation reports available on the Internet. All 

reporting systems (8) reviewed during NASHP site visits protect patient specific information. Reporting system officials unanimously support protecting patient confidentiality. 

Some states release aggregate data that does not identify the facilities or patients 

involved in the incidents (de-identified data). Data elements may include the most 

common injuries, the average number of incidents per facility, or the total number 

of incidents reported. 

States less commonly provide aggregate data that identifies incidents by facility 

name, in part because underreporting leads to incomplete data, making it difficult 

to distinguish between facilities that experience more errors and those that report

more errors because they are more compliant with reporting requirements. However, some states have considered releasing information on the number, type, frequency, and causes of errors by facility. To do so requires risk adjustments for age, 

relative illness, and other complex factors so that users can interpret the data accurately. States continue to struggle with developing risk adjustment methodologies 

that take into account relevant factors that may help explain the frequency of adverse events. 

States may choose to change their approach to disclosure over time. Some may 

choose to release de-identified aggregate data in the early stages of the system’s development and move toward facility-specific data as the system matures, reporting 

increases, and a risk-adjustment technique is identified. 

Examples:

• Colorado’s Internet site posts reported incidents and findings from state investigations. The site can be found at www.cdphe.state.co.us/hf/hfd.asp.

• Florida’s statute makes reports confidential and not subject to discovery or 

admissible as evidence in civil lawsuits. Data cannot be shared with other 

state agencies. Aggregate data are available upon request but names of facilities and individuals are not available. 

• Kansas prepares an annual report using aggregate data by facility size for 

the average number of incidents reviewed, the total number of reportable 

54

events, and the total number of reportable events reported to each professional board. • Massachusetts does not have any legal data protections for reported incidents. However, patient specific information and some peer review protected information may not be released. All information in the reporting 

system, including formal narrative reports, deficiency statements, and facility personnel interviewed during investigations, is available to the public 

upon request. • In 2001, New York prepared its first annual report that identifies hospitals 

with reporting rates significantly below what is anticipated: 

www.health.state.ny.us/nysdoh/commish/2001/nyports/nyports.htm. • Washington incident reports are subject to public disclosure but names of 

individuals are redacted.

How states use data 

The overriding reason for mandatory reporting systems is to hold healthcare facilities accountable for preventable adverse events that result in serious injury or 

death. Accountability is achieved by investigating the event, providing expertise or 

information to help remedy the problem, and insuring that appropriate changes are 

made and sustained to avoid the problem in the future. Investigation may be made 

on-site by clinicians. 

A secondary purpose of a mandatory reporting system may be to improve overall 

quality and patient safety across facilities. Over time as experience and expertise 

have grown, many state reporting systems have shared lessons learned from individual reporting incidents by aggregating data to identify trends. Some states issue 

patient safety alerts, distribute newsletters that highlight trends and best practices, 

and operate websites that can be used by facilities to compare their patient safety 

history to peer facilities. 

To varying degrees, all states share information with professional medical, nursing, and pharmacy boards if reports indicate that a professional violation may have 

occurred. 

Examples:

• Colorado has established an Occurrence Advisory Committee, composed of 

providers, consumers, and state representatives, to assist the state in making better use of reported data. • Kansas publishes newsletters highlighting trends and describing practices 

to reduce repeat incidents in those areas. • Massachusetts provides data to the Massachusetts Coalition for the Prevention of Medical Errors to determine approaches for alerting and informing 

facilities about the risk of errors and practices for addressing identified 

problems. • New York’s system includes a report generation function that allows facilities to track and trend their own incidents and to compare their performance against peer facilities, within their regions, and statewide.

Other state patient safety activities

• Public/private partnerships: Coalitions have diverse memberships, often including providers, government, insurers, health plans, consumers, and community stakeholders like major employers, labor unions, or teaching institutions. Stakeholders determine the mission, goals, objectives, and policies of 

the group. With the exception of peer review data, these groups share 

knowledge and resources with other interested parties in the community, 

including governmental bodies. They take actions to address specific problem areas, for example, medication errors, wrong site surgery, peer review 

protections for reported adverse events, and education of professionals 

about error prevention. Statewide public/private patient safety coalitions 

have been formed in twelve states: Arkansas, Colorado, Georgia, Maryland, 

Massachusetts, Michigan, Minnesota, Ohio, Pennsylvania, Tennessee, Virginia, and Wisconsin. • Public purchasers: Public employee purchasers in Maine, Massachusetts, 

Minnesota, Washington, and Wisconsin have forged relationships with private providers to mobilize employer purchasing power to improve health 

care safety and give consumers information to make informed health care 

choices. 

• State legislatures continue to increase their efforts to address patient safety.

55

1 A Virginia bill was not enacted but was implemented in 2000 by request of the Speaker. 

That bill is counted as an enacted bill for 2000. 2 HI, MA, NY, OK, and WA. 3 CA, FL, HI, IL, MA, MN, MO, NJ, NY, PA, SD, VA, WA, and WV. 4 CA, CT, FL, GA, IL, IN, IA, KY, ME, MD, MA, MI, MN, MO, NV, NH, NJ, NY, OR, PA, 

VA, and WV. 

SUMMARY OF STATE LEGISLATIVE ACTIVITY: 1999—2001*

1999 2000 2001 

No. of bills introduced11 34 61

No. of bills enacted 1 101 12

No. of states introducing legislation

52 143 224

Issues addressed 

by enacted legislation

whistleblower protections whistleblower protections whistleblower protections 

system-wide analysis; 

study commission; 

report to legislature 

system-wide analysis; 

access to data, 

study commission, 

report to legislature 

reporting requirements reporting requirements 

improved safety 

through language 

access 

establishment of patient safety center 

medication error reduction required activities as 

condition of state 

licensure 

public disclosure of 

information 

public disclosure of 

information 

* most recent year available 

NASHP documents on state activities related to patient safety 

Sharon Conrow Comden and Jill Rosenthal, Statewide Patient Safety Coalitions: 

A Status Report (Portland, ME: National Academy for State Health Policy, May 

2002). 

Jill Rosenthal and Maureen Booth, How Safe is Your Health Care? A Workbook 

for States Seeking to Build Accountability and Quality Improvement through Mandatory Reporting Systems (Portland, ME: National Academy for State Health Policy, 

November 2001). 

Jill Rosenthal, Maureen Booth, and Anne Barry, Cost Implications of State Medical Error Reporting Programs: A Briefing Paper (Portland, ME: National Academy 

for State Health Policy, May 2001). 

Jill Rosenthal and Trish Riley, Patient Safety and Medical Errors: A Road Map 

for State Action (Portland, ME: National Academy for State Health Policy, March 

2001). 

Jill Rosenthal et al., Current State Programs Addressing Medical Errors: An Analysis of Mandatory Reporting and Other Initiatives (Portland, ME: National Academy 

for State Health Policy, January 2001). 

Jill Rosenthal, Trish Riley, and Maureen Booth, State Reporting of Medical Errors 

and Adverse Events: Results of a 50–State Survey (Portland, ME: National Academy 

would like to return to your statement, at the end of your prepared 

for State Health Policy, April 2000).

Chairman JOHNSON. Thank you, Ms. Rosenthal. Dr. Leape, I 

f remarks. You stated that section 1182(D) that allows disclosure for 

56

disciplinary proceedings and removes protections of that information needed as part of a disciplinary proceeding, would nullify all 

the benefits of the bill. Would you enlarge on that? 

Dr. LEAPE. Yes, I would be pleased to. I think we ought to be 

clear that the bill provides protection for information that is shared 

from a hospital with a , and I think that is critically needed. Clearly, it does not mean that all the information is protected for any 

use whatsoever. For example, the information would include information that is in the medical record, the patient’s diagnosis, what 

happened, all those things. Clearly, nobody has in mind that that 

should not be available. 

For disciplinary procedures, all of that information is currently 

available. We have mechanisms now for disciplinary procedures, as 

we do for malpractice, which include the ability to examine witnesses, to take depositions, to examine the records in the hospital, 

and all of these, as I understand it, would not be impacted nor 

should be impacted by this legislation. 

So, I do not think we need to remove that protection in order to 

achieve what we want in the way of appropriate disciplinary procedures. If that exclusion is there, then physicians and nurses will 

not report in the voluntary system. They will feel that they have, 

in effect, lost their peer review protection and I think it will literally set the process of voluntary reporting back. 

Chairman JOHNSON. Thank you. I thought that was a very 

strong statement and we will—I will, at least—give it very careful 

consideration. 

Dr. Wood, would you explain a little bit more thoroughly why the 

JCAHO process resulted in 2,000 events reported and why you 

think the MedMARx resulted in 400,000 in a year. That is an astounding difference in the amount of knowledge developed as a result of differently structured reporting systems. Now, what is the 

difference and why 2,000 versus 400,000? 

Dr. WOOD. Madam Chairman, I think this relates back to the 

statement you made earlier in this hearing, that what we are really trying to do is to improve the error-prone care processes, in other 

words, systematic improvement. 

What we see in the JCAHO sentinel events program is the reporting of the most egregious events, in other words, the events 

that result in death or harm. These are not the areas—this is not 

the focus of attention, to try to get to improvement in health care 

processes. The much greater opportunity are those things that are 

recognized as a potential accident that do not result in egregious 

harm to the patient. I think the statistics I quoted give some idea 

of the relative magnitude of those two opportunities. 

That is why I think if we focus our attention through this bill 

on trying to draw out of the woodwork, if you will, the near misses, 

this will give us the best capacity to really get at and improve 

these processes, whereas if we continue to focus on those that are 

only the sentinel events, we will only see a small fraction and it 

will take us years and years to try to get at improved processes if 

those are the only ones that we are focusing on. 

I think that is where the fundamental discussion about voluntary 

versus mandatory reporting comes out. The voluntary will help 

57

bring these near-misses out, whereas the mandatory will always 

drive those underground. 

Chairman JOHNSON. A more concrete example, I think, in my 

life, is represented in a manufacturing portion of the country. For 

a long time, we focused on looking at our rate of perfection at the 

end of the manufacturing process and the amount of goods that you 

had to reject because they were not perfectly done. This was a very 

big issue, and we focused harder and harder and harder to try to 

bring down that error rate, if you will, at the end. Actually, it was 

not until we began to look at process that we actually reduced 

scrap in the more concrete setting of manufacturing. Certainly, I 

just have been very impressed in my life with how attention to tiny 

details that seem to be irrelevant to the end product end up affecting the end product very much. 

Now, I want all of you to respond to Ms. Rosenthal’s concern, 

which I consider to be absolutely real and legitimate. States are 

pursuing mandatory systems. My own State adopted a mandatory 

system. However, they have a very narrow definition of what must 

be reported under that mandatory system. It has to be associated 

with death or serious measurable disability. 

So, I do not know whether the other States all have that narrow 

of a definition, but Ms. Rosenthal did imply that their focus primarily and that the IOM saw the mandatory system as focused primarily on that kind of an ‘‘error.’’ Now, we all know that some of 

those cases that end up to be death or disability are not the result 

of error, they are the result of high-risk surgery and the outcome 

was going to be bad and this was a chance to try to change it. So, 

I think you have to be careful about identifying all of those reports 

as necessarily error-related. States are requiring all those reports 

so that they can look and see which are error-related, and that is 

useful. 

Now, as I understand her testimony, and I will give her a chance 

to enlarge on it in a minute, but as I understand her testimony, 

she is saying two things. First of all, everybody needs a mandatory 

reporting system, we should mandate that. Second, she is saying 

it would create two reporting systems. Now, there is a slight contradiction in her testimony about this dual reporting system because the IOM is proposing a dual reporting system and they do 

overlap. There is no way of getting away from that. 

So, how do you currently, in your own institutions as the system 

is currently developing, deal with the dual reporting? I mean, if we 

put this in place and this system comes up, what will be its impact 

on the mandatory reporting system of your State? Dr. Wood? 

Dr. WOOD. Perhaps I could try to respond to that in this way. 

Chairman JOHNSON. I am really expecting all of you to. I want 

Ms. Rosenthal to be able to enter in whenever she wants to, and 

she can just sort of signal that, because we need to hear this discussion about the inevitable—I mean, inevitably, this is going to be 

a dual reporting system. Even if you do it the way the IOM wanted, it is going to be dual. So, let us talk about that straight out 

and get it out and see, make sure that we do this as well as we 

can. Dr. Wood? 

Dr. WOOD. I truly do not believe this is an either/or situation, 

and I agree with you, Mrs. Johnson, that having two pathways, if 

58

you will, for two different sets of problems would not be incompatible either with the IOM report or with maybe the direction that 

we should be heading in. 

Right now, I do think mandatory reporting is a reality when we 

are talking about the most egregious problems. It is a reality in 13 

States by State mandate, and it is also a reality for the majority 

of accredited hospitals in this country who are associated with the 

JCAHO sentinel events policy. 

What we are lacking is the opportunity and the tool to bring 

those near-misses out so that we can get at the real opportunity 

for process improvement, and that is the value of a voluntary reporting relationship, in my opinion. 

Chairman JOHNSON. Also for the rest of you, in those States 

where there is no mandatory policy, you need to talk about that, 

too. Mr. Segel? 

Mr. SEGEL. The situation in Pennsylvania is still fluid because 

an act has been passed but regulations have not been issued. It 

will require mandatory reporting of serious incidents. By the way, 

a previous system existed that was mandatory but got very few reports because it was not appropriately supported and then there 

was deep mistrust in the system. Then the new act will define a 

reporting process for near-misses, as well. 

I think the reason why I disagree with the statements that have 

been made is because the purpose of this bill is to extend some additional protection to institutions that choose voluntarily to produce 

information and bring it out into the open. It is not, in my view, 

a duplication or an undermining of what might happen in our State 

or any other place. It is instead creating some additional protection 

and safety around information that is brought out into the open, 

and it is voluntary, so it is voluntary to the providers, whether they 

choose to accept that protection in exchange for that commitment 

to the learning system regionally and nationally. 

Chairman JOHNSON. That is an important distinction, that it 

is voluntary. Dr. Pardes? 

Dr. PARDES. I think my colleagues have already stated it rather 

well. I do not see why the one necessarily has to preempt or compromise the other. The idea is to get as much information out on 

the table, which I think will allow us to have much more ground 

on which to reduce medical errors in the broader sense. 

Chairman JOHNSON. Ms. Rosenthal, given the contradictory experience of JCAHO’s system and MedMARx, why do you think it 

is a bad thing to have multiple approaches? 

Ms. ROSENTHAL. I very much think there should be multiple 

approaches. What I was trying to clarify was that the Institute of 

Medicine report recommends both mandatory and voluntary systems as complementary systems that are different in scope, purpose, and function, that mandatory reporting systems are intended 

for the State to hold health care providers accountable for safety, 

for reporting specifically of those events that cause serious harm or 

death, whereas voluntary reporting is intended for those events 

that cause less harm or no harm, and there is no reason not to protect that. 

59

I think the distinction was that if those serious events are reported into a voluntary system, then they are also going to be reported into the mandatory system, so they need to be separate——

Chairman JOHNSON. That is right. In those States that have a 

mandatory law, there will be two pathways. However, the majority 

of States do not have a mandatory law, therefore will be one pathway and at least we will begin to get them started. If we do the 

two-pathway process, which the IOM envisioned, perhaps we just 

need to make a better accommodation in this bill to assure that 

HHS works with each State to minimize or to make as simple as 

possible the collaboration of these two systems. What would be 

your response to that, Ms. Rosenthal? 

Ms. ROSENTHAL. I think that is correct. I think the fear is that 

if all the attention and effort is going into voluntary reporting without support for States to do their part for mandatory reporting, 

then we cannot meet the IOM criteria and we cannot assure consumers that we are working to improve the health care system. 

Chairman JOHNSON. How long have the State laws been in 

place? 

Ms. ROSENTHAL. It depends. Many of them have been in place 

for 20 or so years, but they have been fairly dormant. 

Chairman JOHNSON. See, the 20 or so years have not 

worked——

Ms. ROSENTHAL. Well——

Chairman JOHNSON. In Pennsylvania, or we would know more 

about this. So, in a sense, it is because the old mandatory systems 

did not work that there is such division now in the community 

about whether we should go mandatory or voluntary. What about 

the more recent bills passed by the States? What evidence do we 

have that they are bringing up more than just the report of the incident of death, which I think in most cases was already reported, 

was it not anyway? It certainly was public information. 

Ms. ROSENTHAL. First of all, the reporting systems that were 

created many, many years ago were mostly created—intended for 

a different purpose, and when the Institute of Medicine called attention to this issue, they are now looking for ways to try to improve the system specifically for this purpose. 

Chairman JOHNSON. So were the old systems too narrow? 

Ms. ROSENTHAL. No, I think they were just focused on—they 

were not necessarily using the data to look for the types of things 

that they are looking for now. 

Chairman JOHNSON. Do we understand why they did not get 

many mandatory reports under the old systems? 

Ms. ROSENTHAL. Well, they were not developed to address 

medical errors, but some did report on what have come to be 

known as adverse events. In many cases, the requirements did not 

attract much attention and lay dormant until a tragic event occurred that led to media inquiries about State regulatory oversight 

of hospitals. 

Chairman JOHNSON. What I am really asking is, what do we 

know about the efforts of the States to do mandatory reporting and 

how successful they are? My view is that we do not know a lot yet 

because they have not been in place very long. So, part of my reluctance is to mandate that every State do this. I would like to get 

60

a little further down the road and see how the States are doing 

with that. Meanwhile, I think, not to move ahead with the voluntary system which IOM also recommended would be relatively 

irresponsible. Do you object to moving forward with the voluntary 

system, or is it just that you would like us to also mandate a mandatory system on the States? 

Ms. ROSENTHAL. There is no objection to voluntary, but that 

it be complemented with mandatory. I think that in looking at a 

State, often New York is the State that is used as an example of 

a successful system that receives more than 20,000 reports a year, 

which is quite a few, if you look at JCAHO receiving only 2,000 reports in 5 years from all accredited facilities nationwide. 

Chairman JOHNSON. Two thousand, but it is not a lot if you 

look at MedMARx receiving 400,000. 

Ms. ROSENTHAL. Right, but just for New York State, over 

20,000 is a pretty good number. According to the States with the 

systems, their feeling is that this is an important opportunity for 

them to see what is happening within health care facilities and to 

monitor facilities and identify systems problems as part of their licensure process 

Chairman JOHNSON. What is there in our bill that would prohibit any State that does not currently have a mandatory system 

from adopting a law to have a mandatory system? 

Ms. ROSENTHAL. Resources, mostly, and the inclusion in this 

bill of information on those events that cause death and serious 

harm, which could have a chilling effect on the development of 

State mandatory reporting systems which are intended to collect 

this information. 

Chairman JOHNSON. It is not laws. In other words, we are not 

putting any legal barriers up to the development of mandatory reporting at the State level, correct? 

Ms. ROSENTHAL. That is correct. 

Chairman JOHNSON. Yes. I understand the resource issue, but 

that is true in every area across the country, I mean, in every sector, and it is certainly true in this sector. Dr. Leape? 

Dr. LEAPE. Madam Chairman, based on some of the excellent 

work of Dr. Rosenthal, I think it is a fair assessment to say that 

the reason State mandatory reporting systems have not worked is 

they have all been under-funded. Even New York, which everybody 

touts as being successful because they get 20,000 reports, does not 

have the resources to analyze those reports and make recommendations, to give feedback to do what needs to be done. Reporting without analysis and recommendations is a waste of everybody’s time, 

and that has been the situation in State mandatory reporting systems with few exceptions. 

One of the Institute of Medicine’s recommendations which was 

acted upon was to develop a parsimonious list of reportable events, 

a list of events that everybody would agree are so egregious that 

States have a responsibility to make sure they are reported and investigated. The concept is that if the list is kept small and restricted to things that we all agree are serious, then there would 

be more likelihood of the State being able to insist that these be 

reported and to follow up and do something about them. 

61

The fact of the matter is that very few States do much about any 

of these reports, and as long as that is true, hospitals are not going 

to report because they see no benefit from it, leaving aside all of 

the problems of embarrassment and legal ramifications. I think it 

is beyond the purview of Congress to dictate to States how much 

they can spend for their mandatory reporting systems. 

Chairman JOHNSON. That is a problem, and one of the reasons 

in this bill—I mean, in my first bill, there was no setting aside in 

HHS of a patient safety agency department. There was also not a 

national databank. That is something that, in working together, in 

the draft before the Committee are there and they will require 

funding. As the Secretary pointed out, he wants to be sure he has 

the funding. 

I think we can take responsibility for eliciting reports and for 

analyzing them through the process we have set forward in this 

bill. If we mandate on the States, we would certainly have to mandate money. We are not yet agreed as to how much this bill will 

cost or how we will support that effort at the Federal level. I think 

one really has to begin to ask, do we need 50 abilities as well as 

a national ability to analyze this data? 

I thought your comments, I think it was Dr. Wood but I cannot 

quite remember now—one of you mentioned how some of the peer 

review organizations are providing some analysis of data from single institutions, so there is developing a conversation between 

those who have analytic capability on a smaller scale. That is very 

helpful. We do need to encourage the development of that analytical capability, and right now. I guess, as a Member of Congress, 

I would rather focus on the system that we need to develop for national purposes. That system has to be more encompassing on the 

number of incidents, the number of reports, and types of incidents 

and reports, because the national effort certainly has to be focused 

at prevention and at system change. 

We will, inevitably, encompass also for those States that do not 

have a mandatory reporting system all of the more serious reports, 

as well. So, we will have to watch this over time as each system 

develops and work closely with the States and with offices like 

yours that track all the State developments. I would be happy personally to think through with you if there is any way we can foster 

that collaboration in this bill. Mr. Stark? 

Mr. STARK. Thank you. I want to thank the panel and thank 

you, Ms. Rosenthal, for carrying the water for the IOM here and 

in the States. 

I think that, just to comment on the previous questions, that in 

the bill before us, there probably would not be transparency for 

what is called sentinel events. In other words, there is no distinction in this bill between a death and a near-miss. Therefore, the 

deaths and disfigurements and disabling accidents would not necessarily, or might be prohibited from being transparent, and Dr. 

Leape, you mentioned the importance of transparency in your testimony. 

The American Medical Association (AMA) Code of Medical Ethics 

says that significant medical complications may have resulted from 

the physician’s mistake or judgment. In these situations, the physician is ethically required to inform the patient of all facts necessary 

62

to ensure understanding of what has concern and concern regarding legal liability which might result following truthful disclosure 

should not affect the physician’s honesty with the patient, right? 

You subscribe to that, do you not? Dr. Wood does, I know. He is 

a big guy in the AMA. 

Well, then why would it not be—what would be the objection to 

requiring us patients from knowing that? Would you have any objection to that, Dr. Leape? Why should it not be the law of the land 

that if there is a mistake, that—if I am dead, I guess I do not know 

who you are going to tell, but if I am seriously harmed, why should 

I be told? 

Dr. LEAPE. I do not want to get into a metaphysical discussion 

about how you require people to be good, but I think that there is 

no question that physicians——

Mr. STARK. What little time——

Dr. LEAPE. Subscribe to the concept that the patient has a right 

to know everything that has happened to them, and I think we are 

making a lot of progress in achieving that. The idea that you can 

do that by legislation totally escapes me. 

Mr. STARK. The idea is that if somebody did a little time for 

lying, for not telling the patient, it would have a meritorious effect, 

it seems to me, on the rest of the profession. We have got 100,000 

deaths, at least, from errors related to hospitals a year. Now, nobody dies from near-misses, and we seem to be ignoring those as 

not being very important. I would like to work on those for a while, 

and it seems to me that, yes, there would very likely, although 

there is some literature that suggests that perhaps if hospitals and 

doctors deal honestly with patients up front, they might not get 

mad and sue later. I do not know how you know that or would not 

know it. 

Do you not think that we should, where we have mandatory reporting, require that the patient should be informed? 

Dr. LEAPE. I think what we are interested in doing is preventing injury, and the way to prevent that is to change the systems. Now, most of those 100,000 deaths were not caused by bad 

doctors and bad nurses. They were caused by problems in the systems. If we want people to address those, we have to make it easy 

for them to talk about them and we have to make it easy to address the issues. If we do not do that——

Mr. STARK. If you cannot tell the guy you hurt, who are you 

going to tell? 

Dr. LEAPE. I think there is no question that a physician has a 

moral obligation to be honest with his patient, no question about 

it. 

Mr. STARK. You do not want to make that——

Dr. LEAPE. I do not think you achieve that by legislation. 

Mr. STARK. You do not want to make that a legal obligation. 

Dr. LEAPE. I would not make that illegal, no. 

Mr. STARK. Just so the doctors can lie, so they do not tell us? 

Dr. LEAPE. Not at all. We have a lot going on to change that 

right now and it will change. 

Mr. STARK. The patients do not—I mean, nobody gives a hoot 

about the patients here. It is just protecting the doctors from getting sued. That is what is the trouble with you guys. 

63

Now, Dr. Wood, your comments on the NQF patient safety draft 

report, you say there should be no efforts to Federally regulate or 

mandate any of the safe practices on the steering committee’s list 

until such Federal protections have been legislated and fully implemented. That is your belief, right? 

Dr. WOOD. That is correct. 

Mr. STARK. Okay. Now, you also indicate that this bill and its 

reporting protections are sufficient. So, does that mean that the 

HLC would support federally regulating safe practices once the reporter protections in this bill are fully implemented? 

Dr. WOOD. I think I would be inclined to answer that affirmatively. 

Mr. STARK. Right on. We have made some progress. Would you 

mind if we had in this mandatory reporting the fact that the patient ought to know when there is an accident and there ought to 

be, I think, a criminal penalty for not telling them, but you cannot 

ever know whether somebody is going to be honest with a patient. 

That is the trust issue we have to have. 

Dr. WOOD. Mr. Stark, in getting back to your earlier questions 

also to Dr. Leape, I do not see anything in this bill that prohibits 

the health care profession from informing a patient when there has 

been an accident or error occurring. I think the point that I really 

am trying to make is that this legislation has the opportunity to 

actually benefit and make safer health care by, again, getting at 

the opportunity for process improvement. 

Mr. STARK. If we could start out those near-misses that you are 

talking about and make those only—and I think Ms. Rosenthal 

would buy into this—subject to this confidentiality, leaving what I 

think is referred to as sentinel events, that is bad things, big bad 

things, leaving those under the mandatory reporting structure, the 

problem is in this bill there is no distinction. So, we might start 

to get all the bad or the sentinel stuff in and it would not be transparent and nobody would know about it and that is a danger I see. 

Am I seeing this right, Ms. Rosenthal? I mean, if we could somehow define that, I think the bill would be better. 

Dr. WOOD. I think that a two-pronged approach like that would 

have a real opportunity to enhance patient safety and would be a 

step forward. 

Mr. STARK. Thank you. Does anybody else want to add anything 

that will help the patients while we are here? I do think, and I 

want to, again, I want to thank the IOM and all the people and 

John Eisenberg, who years ago—I hope you will name this after 

him someday when we get the agency going—it is a major concern, 

and I know that the liability is a concern and I know that the humility of making mistakes is awful. I do not know how I know that, 

because politicians never make mistakes, but I do know it. 

I hope that we can, and I think we have to mandate some stuff. 

I mean, I hope we can get the legislation. I would submit that we 

would not have air bags on cars if we had not passed a Federal 

law. I mean, I think we would still be talking about it and saying, 

well, it is voluntary and it costs too much. I think there are some 

things that are inconvenient, they are uncomfortable, they are a 

whole lot of things that do not fit into our making our life happy, 

but that are necessary. 

64

My concerns with the bill, and I think we could perhaps straighten them out, is that we do not stop doing that, whether it is not 

allowing your residents to work more than 60 hours a week because they will make a mistake, or whether it is using the safe needles that we finally had to legislate to get some of the hospitals to 

use. Those are things that I think, sooner or later, people are not 

going to like. They do not like regulations. We do not like them 

here. Madam Chair, I think that if we can decide those major 

events that have to be regulated and then let the profession and 

the industry or the providers work on the rest until they come up, 

I mean, I would be happy to have them decide, but then they are 

going to want to do it because it may be a competitive issue. If 

Mayo has got to do it, then why does Johns Hopkins not have to 

do it? The fact is, they probably should, so go to it. 

Chairman JOHNSON. I would like to come back to Dr. Woods’ 

comment, but I had a long period to question him first. You have 

had a long period of questioning. I am going to turn to Congresswoman Thurman, and then if there is time, we will discuss that 

further, but there are a lot of questions raised by this discussion. 

Congresswoman Thurman? 

Mrs. THURMAN. Madam Chairman and Representative Stark, I 

have to tell you, this has been a good discussion because this is the 

discussion that has been going on in this Committee between the 

Members, I mean, in trying to figure out how do we meet this one 

issue that is now on the table. 

I was encouraged certainly by what Ms. Rosenthal said in the 

two-tier, one mandatory, in those areas, that seems to be where the 

States are heading and that is when there are adverse events, and 

then the one where we all recognize that there are some things 

that go on out there that potentially could cause harm, have not 

caused harm, but can be corrected just because we are seeing it 

happen over and over again. 

So, I am actually very encouraged by this and I think it is what 

I made a comment to Secretary Thompson earlier, was that if we 

could get that discovered in this—maybe discovered was not the 

right word to use in this case, but if we could come up with that 

verbiage to set those two aside, I think we have probably worked 

out a good majority of the issue that has been on the table, quite 

frankly. 

I guess that the only other thing I would say, and I thank Dr. 

Pardes for recognizing some of the work we have done on this in 

the money part of it. It is a huge issue for folks out there. As we 

all know this year, we were talking about cutting hospitals by 0.55 

percent. We have now come back, thanks to HHS, with about a $10 

billion appropriations on the table, but quite frankly, we are talking about a major system and the ability to talk. 

Dr. Leape, I have to tell you, I did not realize it had been 40 

years that this has been going on, but it really certainly tells you 

how we have just come to a standstill on some of these issues. It 

is just not acceptable. I mean, whatever we are talking about here, 

the bottom line is it is lives. It is about people. It is about things 

that can be affected in a positive way, and we are seeing that happening and we are seeing it happening because there has been 

some push over the last couple of years and direction to the States 

65

and others to come up with some ways to do some reporting and 

find out where the problems are. 

If we are standing in the way of not making this where we are 

having a 90-percent success and only having 20-percent success, 

then we need to figure out how to do this. I mean, we are talking 

about one cost at one time to get into some compliance that would 

work. After that, you are on your own. Immediately, the upstart is 

always the hardest to get people to fall into line to do these things. 

Quite frankly, I think we are talking about people’s lives and that, 

to me, is just kind of unacceptable. I would hope that after this discussion, if we look at, and I would say to the Chairwoman——

Chairman JOHNSON. If the gentlelady would yield, because 

there is an aspect of this discussion that I think we need to get on 

the table——

Mrs. THURMAN. I was just going to say, if we go to what Ms. 

Rosenthal has given us in the Academy, I do not know if this is 

a letter that you have, but it is on the second page, basically where 

it says the bill does not distinguish between the purpose of collecting information about medical errors that result in serious 

harm and those that result in minimal or no harm, that, in particular, I think, is the crux of the issue that we have been dealing 

with, and based on some of this conversation today, probably could 

take care of some of the issues we are concerned about. 

Chairman JOHNSON. Ms. Rosenthal, would you prefer a system 

in which matters of serious errors were reported at the State level, 

and in a sense, non-serious errors were reported to the Federal system? Would you prefer that system? 

Ms. ROSENTHAL. I am not sure I got that completely, a system 

where serious——

Chairman JOHNSON. In other words, would you prefer a totally 

bifurcated system? 

Ms. ROSENTHAL. With serious events reported to mandatory 

State——

Chairman JOHNSON. State level. 

Ms. ROSENTHAL. And near-misses, those that cause less serious harm reported to a voluntary system? Yes. 

Chairman JOHNSON. Well, and the voluntary system being national and the mandatory system being State. See, to me, I think 

this would be a terrible error of public policy because you are going 

to have every State having different analytical capabilities to understand the serious incidents in their States. You are going to 

have no national capability to look at incidents from the different 

States. You are probably going to have, not necessarily, but you are 

going to have very varied resources for analysis and feedback from 

State-to-State. 

It seems to me that you want a system that feeds these most serious errors up to the national level as well, and I want our—if I 

am going to fund this, I want to have both the little incidences and 

the big instances. It is from that body of knowledge that you develop system changes, and I do not object—my bill does absolutely 

nothing to prevent States from adopting mandatory reporting systems and moving right along the way they are. I think we need to 

get a little further along with that and see how useful it is and 

what it does. The States cannot do what we need to do, which is 

66

all of this voluntary reporting, because I want things voluntarily 

reported that have no risk at all but just are suppose, you know, 

we could do it better this way. I want people to feel that if I say, 

gee, we could do it better this way, that is not going to come back 

to haunt my institution in a court situation. Well, they should have 

listened to this person. 

So, we have got to protect voluntary reporting if we are going to 

get big ideas and flexibility so you get real systems information. 

Now, to disconnect that, first of all, I am not sure at all that in 

law you could define what information we would protect and collect 

if you try to dissect out of that information universe the information that is associated with serious errors, and I do not know why 

you would want to do that. 

Now, if you think we can define out that information for the voluntary system, you need to tell me what that definition would be 

and then justify why you think that would be a good thing, to have 

the Nation, the national analytical capability associated only with 

the less-serious data. 

Ms. ROSENTHAL. Well, I think it is possible to distinguish what 

is classified as an adverse event or serious harm according to——

Chairman JOHNSON. Wait a minute now. See, we are not just 

talking about that. It is easy to say adverse event and serious 

harm. We are talking about the data associated with those incidents and how that data would not be under the voluntary reporting system, nor would it go to the national level. 

Ms. ROSENTHAL. There has been an effort on the Federal level 

through the National Quality Forum to develop that list of serious 

events——

Chairman JOHNSON. Right. 

Ms. ROSENTHAL. That would be used by States to collect that 

kind of information, and part of the reason that States need that 

data is because they are responsible for licensing health care facilities, so if they do not have that data——

Chairman JOHNSON. That is good. That is all good. 

Ms. ROSENTHAL. So, if this bill makes it more difficult for 

States to enact those systems——

Chairman JOHNSON. It does not make it more difficult. I asked 

that earlier in the questioning and you said you did not see any 

barriers to State progress. 

Ms. ROSENTHAL. Well, I think in my testimony, I tried to describe that there is some—the duplication and not distinguishing 

between those events that cause serious harm versus those——

Chairman JOHNSON. If you are required to report that information to the State, you report it. So, at least in all the States that 

have not passed a mandatory reporting requirement, which is the 

majority, they would be required under our law to report it to us, 

to report it to the—well, they would not be required, because it is 

voluntary, but the likelihood that they do it and the likelihood that 

Federal systems like JCAHO would require them is extremely 

great. 

Ms. ROSENTHAL. It makes it more difficult for the States that 

do not currently have systems. If there is a system that is conflicting on the Federal level and makes it easier for those who 

would be reporting into a mandatory system to say, well, there is 

67

already this system, you do not need to create one on the State 

level, so there is——

Chairman JOHNSON. That is true, but you also acknowledge 

that the States have not put the resources in to analyze the data. 

So, if we get the data reported for the most serious things in the 

State and it is not analyzed and we cut that data out of the voluntary system at the national level, I mean—see, I do not have any 

problem with both. I am appalled that you would advocate this 

total bifurcation. What we want is integration, not bifurcation. We 

do not want side-by-side systems. We want rich reporting systems, 

and there is no harm in the State reporting and analyzing. Maybe 

some of their people will be better and that will be rich, but I see 

a lot of problems with bifurcation. Mr. Segel, and then——

Mrs. THURMAN. Could I——

Chairman JOHNSON. Let me let Mrs. Thurman clarify her 

thoughts on my thoughts, and then you can all respond to that. 

Mrs. THURMAN. You can tell we have kind of been through this 

already once. 

Chairman JOHNSON. Well, we have not been through this particular thing, and this is good. 

Mrs. THURMAN. It is very important, though, I agree. 

Chairman JOHNSON. Because you can have theoretical ideas, 

but if you cannot write them in law, you do not have a system and 

you do not have a law. 

Mrs. THURMAN. I think part of the problem is, if you develop 

one at a voluntary, at the Federal level, then that takes precedence 

over the State. So, if the States have put this mandatory in, they 

send it up to the Federal and say, well, I have already done this 

and it is voluntary. I do not know if that is part of the problem. 

I mean, we supercede State law in these kinds of issues, so you 

could potentially undo what some of these States have already 

done. Is that——

Chairman JOHNSON. To that issue, though, let us get that 

clear, because I do not think Ms.——

Mrs. THURMAN. That is what I am asking. 

Chairman JOHNSON. All right. Sorry, I thought you were saying—because I asked you this earlier, Ms. Rosenthal, so proceed. 

I think the question is, does this law supercede State law? 

Ms. ROSENTHAL. Well, some of the—if adverse events are required to be reported—if adverse events are included in a Federal 

voluntary system and there is confidentiality protections for that 

data, if that interferes with the State mandatory system that 

makes that information available to the public, there could be——

Chairman JOHNSON. There is no provision in this bill that says 

if you report it to us, you do not have to report it to the State 

under the State law. There is no provision that does that. So it is 

true, your argument that they will have to report to two entities, 

that is a valid argument. To say that in any way this bill interferes 

with State law is really—you have to document if you are going to 

say that. I have said enough. Mr. Segel? 

Mr. SEGEL. Maybe it would be worth putting into the legislation 

a specific clause that says, nothing in this bill preempts the responsibility to report under State mandatory reporting systems. Something as simple as that might solve it. 

68

Chairman JOHNSON. Certainly, those things can be done. 

Ms. ROSENTHAL. I guess what that does—I would agree with 

that, also, but I think what that does not address is what the IOM 

recommendation called for was two types of systems, with State 

systems funded at the national level, and I think the concern of 

States is that if this bill goes forward as voluntary reporting only 

with funding, that there will not be future funding available as recommended in the IOM report for States for the mandatory systems. 

Chairman JOHNSON. With the pressure to fund prescription 

drugs, do you really think there is going to be very much future 

funding? I mean, if we can get this system funded, do you think 

we are going to fund State systems? 

Ms. ROSENTHAL. Honestly, no. 

Chairman JOHNSON. So, let us not kid ourselves. If we can get 

one system that clearly has to be voluntary if it is national, and 

it is going to be over all people, all incidents, and all providers, because most State systems are only over hospitals, most of them are 

not over doctors, it is my recollection, is that not true? 

Ms. ROSENTHAL. The systems are for facilities, not for individual——

Chairman JOHNSON. Facilities and not for individuals. Ours is 

much broader than that. So, if you are going to do the big universe 

of reporters and the big universe of data and we can get the analytical capability to fund it, we are just not going to ever be able to 

do the other, and you might as well be honest about that. 

So, if States have not seen that it is important to fund analysis 

as well as to do the political thing of requiring reporting, that is 

something real. Look how States are under-funding their Medicaid 

reimbursements. I mean, States are not doing a good job. So, if we 

could do a good job of this one thing, we would be ahead. Mr. 

Segel? 

Mr. SEGEL. Congresswoman, it has been a rich discussion. I just 

want to say I do agree with your reading of the bill and in its importance, further, and this is really a plea to the panel, health care 

professionals want to report. The JCAHO reports, at the level that 

they are at, they are essentially out the door of hospitals but 

stopped because of the lack of this kind of protection extending to 

those reports. I think if you are able to move where the great gap 

has been by providing some additional protection for voluntary reporting and again, it is not protecting the underlying events or a 

patient’s right to their record at all, but it is to be able to talk 

about errors and analyze and provide some additional support for 

that process you are going to see the floodgates open. I can guarantee it from our own experience. 

The task is really to take it out of the sort of legal environment 

within the institutions as well as externally and allow what people 

are desperate to have happen internally happen, and if you conceive of it in those terms or conceive of it as taking away an excuse 

not to act, that is the opportunity before this panel and it is the 

one that health care professionals who want to do the right thing 

are crying out for. 

Chairman JOHNSON. Dr. Wood, since you supported a dual system, you had better have a few words here. 

69

Dr. WOOD. In responding to Congressman Stark’s earlier question, I think what we really are trying to do is do anything positive 

that is realistically passable to improve the safety for patients. I 

really do believe that the more we have a mandatory requirement 

in the bill, the more obstacles we will have in front of us. 

In my own opinion, we already have a large number—for the 

kind of cases that Dr. Leape was referring to earlier, the truly 

egregious type areas, the cases that the IOM report was trying to 

get to, we actually have some mechanisms in place as we exist 

today through JCAHO and through some State mandates, and if 

putting a mandatory provision in this particular bill, I can’t help 

but feel that it will increase some of the barriers to getting it 

passed. 

If we have the opportunity to move forward with the voluntary 

activity alone, to eliminate those barriers, and in order to bring 

those near-misses out of the woodwork, I think that would be the 

most positive step forward. 

Chairman JOHNSON. Well, I can tell you flat out, there is no 

way that I can get a bill on the House Floor to pass—I am not sure 

I can even get it as far as the House Floor, but you cannot pass 

a clear unfunded mandate on the States at this time, nor would it 

be fair. They all have deficits. You particularly cannot do that 

when you have not funded anything yourself——

Dr. WOOD. Right——

Chairman JOHNSON. That covers all that vast amount of opportunity to reduce errors that they cannot reach. So, if we have to 

go to mandatory, then this bill is dead, no question about that. 

Thank you very much. I really feel like we have to——

Mrs. THURMAN. Can I just——

Chairman JOHNSON. Yes. Congresswoman Thurman? 

Mrs. THURMAN. This is where some of our concern comes from. 

In the bill on page seven under the last, starting online 33, it talks 

about no limitation of other privileges. ‘‘Nothing in this section 

shall be construed to limit other privileges that are available under 

Federal or State laws that provide greater peer review or confidentiality protections than the peer review and confidentiality protections provided in this section.’’ I think that is where some of these 

questions are coming from as far as the supremacy of the States 

and those that, in fact, would have and are addressing mandatory. 

That is the problem. For us who live in States and have sunshine 

laws and things like that, it is very difficult to go against your 

State legislature that have put these protections in, and particularly when you look at the kinds of pieces of legislation that are 

being filed every day. 

I agree with Chairman Johnson in the fact that I would love to 

have this done so that we could get some of this information and 

make it national, but I also recognize that there are States out 

there that will continue to do this, and for us to get in their way 

when they have the licensing, they are going to get the phone calls 

in their offices, it makes it very difficult. 

Chairman JOHNSON. We will certainly look at trying to clarify 

that nothing we are intending to do here will in any way limit the 

responsibility of facilities to comply with State laws. We will certainly do that. 

70

Mrs. THURMAN. Thanks. 

Chairman JOHNSON. Thank you very much for your patience 

and for helping us on this discussion. It is an important one. The 

hearing is adjourned. 

[Whereupon, at 2:34 p.m., the hearing was adjourned.] 

[Submissions for the record follow:]

Statement of the American Academy of Family Physicians 

Introduction

This statement is submitted to the Ways and Means Health Subcommittee regarding the Chairman’s mark of H.R. 4889, the Patient Safety Improvement Act of 

2002. This statement is offered on behalf of the 93,500 members of the American 

Academy of Family Physicians (AAFP). 

Support for Confidentiality Provisions in H.R. 4889 as Introduced

More than 12 times as many people are seen in primary care physicians’ offices 

as in hospitals. Because the majority of patient encounters occur in the physicians’ 

office, the Academy believes that the creation of a learning culture in ambulatory 

care settings has the capacity to improve care for the greatest number of patients. 

Developing such a culture depends on federal protections of confidentiality and voluntary reporting contained within the Patient Safety Improvement Act, as it was 

introduced. 

According to the bill, reporting non-identified patient safety information to patient 

safety organizations would be voluntary for every level of the health care delivery 

system—physician, health care provider, hospital or health care system. The Academy supports the creation of patient safety reporting systems based on the voluntary reporting of non-identified data. We believe that these provisions are prerequisites to building a non-punitive quality improvement culture that focuses on 

preventing and correcting system failures and not on assigning individual or organization culpability. As the IOM study noted, ‘‘improving patient safety requires fixing 

the system, not fixing blame.’’

The bill classifies information documented, collected, or prepared for submission 

to a patient safety reporting system, as privileged and confidential. Furthermore, 

federal protections against disclosure in civil, criminal, or administrative proceedings are created unless a judge finds the release of the information meets a 

strong three-pronged test: that it is material to the case; that it is in the public interest; and that it is not available from any other source. The Academy appreciates 

the bill’s treatment of sensitive information. 

Concerns with H.R. 4889 and the Chairman’s Mark

The Academy has concerns that the Chairman’s mark contains a weakening of the 

federal confidentiality protections against having patient safety reports introduced 

into a legal proceeding. As introduced, H.R. 4889 extends federal protections against 

disclosure in civil, criminal, or administrative proceedings unless a judge finds the 

release of the information meets a strong three-pronged test: that it is material to 

the case; that it is in the public interest; and that it is not available from any other 

source. The Academy believes that these protections are essential to an effective 

quality improvement system. However, the current Chairman’s mark would remove 

these protections from criminal matters. Abandoning this protection seriously jeopardizes the likelihood that health care professionals will disclose to a PSO the noncriminal errors that they see in the course of delivering medical care since reports 

could be subpoenaed based on the claim that they were related to a crime. 

Likewise, the Academy is concerned H.R. 4889 amends the Social Security Act 

and places these protections under Medicare, instead of under the Agency for 

Healthcare Research and Quality (AHRQ) by amending the Public Health Service 

Act. AHRQ is the only agency dedicated to research that focuses on access to high 

quality, cost-effective services; and improved health status throughout the health 

care system. The Academy believes that existing error reporting systems, which are 

the first candidates for Patient Safety Organization (PSO) status, have existing research connections to AHRQ and see this national center for primary care research 

as the most appropriate place to house patient safety efforts. 

The protections offered under The Patient Safety Improvement Act are available 

solely to physicians with Medicare billing numbers. Therefore, under the bill, primary care physicians without Medicare billing numbers need to go through the 

Medicare physician billing application process solely for the purpose of obtaining a 

billing number in order to claim federal protections for reported data. This provision 

71

alone is likely to have a chilling effect on reported data. Likewise, the Academy has 

concerns that the application of all Medicare fraud and abuse laws to PSOs would 

have a chilling effect on reporting for both physicians and the PSO itself. 

Conclusion

The Academy appreciates this opportunity to submit a statement to the subcommittee and looks forward to working with you to develop effective patient safety 

legislation. This is a matter of continued interest to the Academy and we thank the 

Ways and Means Health Subcommittee for its interest in the topic.

Statement of the American College of Obstetricians and Gynecologists 

f The American College of Obstetricians and Gynecologists (ACOG), an organization 

representing nearly 45,000 physicians, commends you for your leadership to improve 

patient safety. As partners in women’s health care, we strongly support legislation 

that works to eliminate health care errors and ensure quality care for every woman. 

The College encourages physicians and other health care professionals to participate in a voluntary, non-punitive system to report and evaluate errors and share 

their experiences with others. We support the principles that provided the foundation for the Institute of Medicine’s 1999 report entitled, To Err is Human. It is imperative that we work together to transform the health care system into a culture 

of safety, which focuses on information sharing to prevent adverse outcomes. We believe that information must be subject to comprehensive analysis to identify actions 

that will minimize the risk that reported events would recur. Likewise, we find it 

equally important to protect the confidentiality of both physicians and patients and 

to defend all information submitted to patient safety reporting systems as privileged. 

One of the College’s most successful programs to date is the Voluntary Review of 

Quality Care (VRQC) program, established in 1986. The mission of the VRQC program is to provide peer review consultations to departments of obstetrics and gynecology, assess the quality of care provided, and suggest possible alternative actions 

for improvement. At the request of hospitals, this program makes available two or 

more board-certified, practicing obstetrician-gynecologists to evaluate the hospital’s 

clinical performance in obstetrics and gynecology. The program offers comprehensive, department-wide reviews that focus on all practitioners with obstetricgynecologic privileges and focused reviews of an individual physician’s quality of 

care. 

During the site visit, the reviewers use various quality improvement techniques, 

including an evaluation based on the College’s policies and publications. Based on 

findings revealed from hospital data, medical record review, and interviews of key 

hospital staff, the review team provides a confidential comprehensive final report for 

the hospital containing specific recommendations. These reports are valuable tools 

in promoting constructive changes and helping to identify potential areas for improvement of quality of care provided. Typically, the report contains recommendations on how to improve the system, adopt new programs, and address the hospital’s 

particular concerns. 

Programs like the VRQC serve as the foundation to our efforts to ensure quality 

care. This successful program, however, is only one of the many tools we offer our 

physicians. For three decades, the College has published a line of publications to inform and assist our physicians who participate in peer review and quality improvement activities. Our 2000 volume, Quality Improvement in Women’s Health Care, is 

intended to serve as a primer for obstetricians and gynecologists starting or managing quality improvement programs within their respective hospitals. Because we 

believe that our role as a medical specialty society is to serve as a catalyst for improvement, we continue to reach out to our physicians through postgraduate continuing medical education courses as well. 

Thank you, Madam Chairwoman, for your leadership on this important issue and 

for the Subcommittee’s attention to patient safety. ACOG appreciates the opportunity to present our concerns for the panel’s consideration. The College looks forward to working with you as we push for a meaningful solution to ensure greater 

patient safety in the delivery of quality health care for every woman.

f

72

Statement of the American College of Physicians-American Society of 

Internal Medicine 

The American College of Physicians-American Society of Internal Medicine (ACP–

ASIM), representing more than 115,000 internal medicine physicians and medical 

students, is the nation’s second largest medical association. The ACP–ASIM commends Chairwoman Nancy L. Johnson for her leadership on the issue of patient 

safety and for holding this hearing as well as the hearing on March 7. 

The findings of the late 1999 Institute of Medicine (IOM) report ‘‘To Err is 

Human: Building a Safer Health System’’ are as dramatic and unacceptable now as 

they were two and a half years ago. The number of injuries and deaths from medical 

errors is open to some dispute, but there is universal agreement that the number 

is unacceptably high. Since the report was issued, both government and the private 

sector have made significant efforts to improve safety in the healthcare system, but 

much remains to be done. 

The College accepted the IOM’s challenge to the medical profession by undertaking an ambitious effort to provide our members and other physicians with the 

information and tools they need to create a safer healthcare system. 

The ACP–ASIM quickly identified the need to address patient safety in the outpatient setting. Care is increasingly being delivered in ambulatory settings while 

most of the research has focused on errors in the hospital. The College embarked 

on a multi-year, multifaceted initiative, ‘‘The Other Side of the Quality Equation,’’ 

to raise physician awareness of quality issues and facilitate physician behavior that 

is likely to diminish the occurrence of medical errors. The cornerstone of this Agency 

for Healthcare Research and Quality (AHRQ)-supported program is the development 

of a patient safety curriculum to teach physicians how to achieve patient safety in 

the ambulatory setting. 

In addition to the courses being given at state chapter scientific meetings, a webbased interactive learning tool, PSILC (the Patient Safety Interactive Learning 

Community), has been developed for physicians to review courses and participate in 

discussions online. The effectiveness of these interventions will be measured 

through surveys addressing awareness, attitudes and reported change in safety behavior. 

Beyond the College’s efforts to provide physicians with significant patient safety 

education opportunities, the ACP–ASIM has strongly advocated for confidentiality 

protections to encourage voluntary reporting. We also support a strong national 

leadership role for the Center for Patient Safety in the development of uniform reporting methods and analysis of patient safety data. 

Confidentiality Protections for Voluntary Reporting

The IOM report found that medical errors are the result of problems in the 

healthcare system, not of individuals. It states ‘‘The focus must shift from blaming 

individuals for past errors to a focus on preventing future errors by designing safety 

in the system.’’ Medical errors often are complex events resulting from a series of 

undetected mishaps. To identify, correct and prevent medical errors, collaboration 

among health care professionals, administrators, and institutions is required. This 

cannot be done in a system where the fear of litigation is pervasive. Neither can 

it be done in a medical culture that discourages discussion of mistakes and the inevitable human error is a source of shame. 

The College supports the expansion of peer-review and confidentiality protections 

to encourage providers and others in the healthcare system to come forward with 

vital information needed to make improvements. Information that is developed with 

respect to system shortcomings (root-cause analysis) and subsequent analysis to prevent such errors in the future should not be ‘‘discoverable information’’ used in litigation. However, this privilege should not interfere with disclosure of information 

that is otherwise available. 

The chairman’s mark limits protections to civil and administrative proceedings 

and appropriately excludes criminal proceedings. In addition, disclosures are permissible in a disciplinary proceeding if the disclosure is material to the proceeding, 

within the public interest and not available from any other source. Since the rules 

that govern disciplinary hearings vary substantially, it would be useful to address 

whether this limitation creates a loophole sufficiently large to discourage reporting 

of medical errors. The challenge is to strike a balance between the need for confidentiality to encourage reporting and the public’s right to information that will 

provide protection from incompetent providers. 

A Strong Role for AHRQ in Patient Safety 

The legislation establishes a strong role for AHRQ’s Center for Patient Safety. 

The Agency will continue to take the federal lead on research, evaluation and demVerDate jul 14 2003 07:07 Sep 04, 2003 Jkt 086199 PO 00000 Frm 00076 Fmt 6633 Sfmt 6621 E:\HR\OC\86199A.XXX 86199A
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onstrations on patient safety either directly or through grants. The Center will certify patient safety organizations, defined in the bill as private or public organizations that collect and analyze voluntary reports and develop and disseminate information on best practices in patient safety. The Center will establish a National Patient Safety Database to collect and analyze non-identifiable data. The Agency has 

built an impressive record in patient safety and this legislation allows that legacy 

to continue. 

Medical Information Technology Board (MITB)

The bill establishes a new Medical Information Technology Board (MITB) to report on best practices in medical information technology and methods for implementing interoperability (e.g., compatibility of information technology architecture) 

standardization and records security. The Board is required to report to the Secretary after 30 months and to report each year for two years on advances in information technology, best practices and on private sector efforts to implement interoperability standards. 

Advances in medical technology will play an enormous role in improving clinical 

care and efficiencies in the healthcare system. ACP–ASIM recommends that the 

Board meet on an ongoing basis beyond the 30 months specified in order to keep 

pace with the rapidly evolving field of informatics and be evaluated for permanent 

status after a three-year period. 

The bill establishes a diverse board of 17 members, including staff representatives 

from the Centers for Medicare and Medicaid Services, AHRQ, IOM and public 

health agencies, and representatives with expertise in informatics from industry and 

educational institutions. Significantly, the bill also includes ‘‘individual and institutional health care clinical providers.’’ We strongly support the inclusion of clinicians 

who can provide a practical assessment of what is feasible in day-to-day practice. 

We also suggest that the Board draw upon the expertise of existing organizations 

such as the American Medical Informatics Association and Health Level Seven 

(HL7), an American National Standards Institute-accredited Standards Developing 

Organization. It would be a significant contribution if the Board could facilitate communication and coordination among myriad organizations in the field of informatics. 

Finally, the number one goal among the six enumerated for the Board is to maximize positive outcomes in clinical care, including decision support for diagnosis and 

care. The College has invested significantly in a decision support tool, the ‘‘Physicians’ Information and EducationResource (PIER),’’ and continues to expand the 

electronic Web-based resource. Modules are available now on the diagnosis and 

treatment of diseases such as lymphoma and asthma. Strides in healthcare quality 

will be realized through medical informatics tools that provide physicians with evidence-based guidance at the point of care. 

Conclusion

It would be a significant accomplishment for the Committee to report legislation 

that could be passed in this Congress. Confidentiality protections for patient safety 

data and a strong role for AHRQ would result in improved safety and quality in 

the healthcare system.

Statement of the American Medical Association 

f On behalf of our physician and medical student members, the American Medical 

Association (AMA) applauds Chairwoman Johnson’s continuing leadership to improve patient safety and quality of health care in our nation through federal legislation that would remove the barriers that prevent the reporting and analysis of 

health care errors. The AMA shares Chairwoman Johnson’s goal, and supports the 

Chairwoman’s bill, H.R. 4889 (the ‘‘Patient Safety Improvement Act of 2002’’), as introduced on June 6, 2002. We do, however, have concerns about the draft chairman’s 

mark of the legislation which are discussed below. We submit this statement as a 

supplement to our March 7, 2002, Statement for the Record to the Ways and Means 

Health Subcommittee, which provides a detailed account of the myriad efforts on 

behalf of the AMA and other public and private health care organizations to improve patient safety and health care quality. 

We believe that H.R. 4889, as introduced, would provide a framework by which 

our nation’s health care system could more effectively advance patient safety initiatives and further promote the reporting and analysis of health care errors. Such a 

framework was envisioned by the Institute of Medicine (IOM) in its 1999 report, To 

Err is Human: Building a Safer Health System. In that report the IOM recVerDate jul 14 2003 07:07 Sep 04, 2003 Jkt 086199 PO 00000 Frm 00077 Fmt 6633 Sfmt 6621 E:\HR\OC\86199A.XXX 86199A
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ommended that ‘‘Congress should pass legislation to extend peer review protections 

to data related to patient safety and quality improvement that are collected and 

analyzed by health care organizations for internal use or shared with others solely 

for purposes of improving safety and quality.’’ The IOM also noted that a federal 

approach is required because ‘‘many current state peer review statutes . . . may not 

protect data about errors shared in collaborative networks, especially across state 

lines, or reported to voluntary reporting systems.’’

Concerns About the Draft Chairman’s Mark of H.R. 4889

Upon reviewing a draft of the chairman’s mark of H.R. 4889 (dated August 2, 

2002), we noted several changes to the original language. One of these changes that 

raises concerns would alter the scope of the confidentiality and legal protections for 

the unique ‘‘patient safety data’’ that would be reported to a ‘‘patient safety organization.’’ Section 1182 in H.R. 4889, as introduced, extends the federal confidentiality 

and legal protections to a ‘‘civil, criminal, or administrative’’ subpoena and proceeding. The draft chairman’s mark would limit the protections to a ‘‘civil or administrative’’ subpoena and proceeding. 

The reporting of a criminal act is a fundamental requirement under state and federal laws and should not in any way be limited. The AMA believes that discovering 

adverse patient safety events that occur as a result of a criminal act is an inherent 

benefit of a patient safety system. The original language in H.R. 4889 (in section 

1182) would allow any information about criminal behavior that is uncovered or otherwise discovered by a ‘‘patient safety organization’’ to be disclosed to the appropriate ‘‘health care provider’’ (hospital, clinic, etc.), which must then report such 

crimes under numerous existing state and federal laws. 

For criminal or disciplinary proceedings, the original language of H.R. 4889 (in 

section 1182) already allows for the disclosure of ‘‘patient safety data’’ in situations 

where such data would be ‘‘(A) material to the proceeding; (B) within the public interest; and (C) not available from any other source.’’ Therefore, the protections 

in the original legislation would in no way limit or affect the availability 

of any information or evidence that is currently available under existing 

law. More important, maintaining the legal protections in the original language could result in criminal behavior being identified by ‘‘patient safety 

organizations’’ sooner or where it might have altogether been missed.

The AMA is concerned about the provision in section 1182(h), which would treat 

patient safety organizations as business associates under the Department of Health 

and Human Services Privacy Rule promulgated pursuant to the Health Insurance 

Portability and Accountability Act of 1996 (HIPAA). The provision would also deem 

activities of ‘‘patient safety organizations’’ to be health care operations of health care 

providers under the Privacy Rule. This could be problematic for physicians and 

other health care providers. 

HIPAA only applies to ‘‘covered entities’’ (all health care providers, including physicians and hospitals, health plans and clearinghouses). The Privacy Rule requires 

‘‘covered entities’’ to ensure that any patient information disclosed to business associates (accountants, consultants, billing companies, etc., and other entities that may 

not be covered by HIPAA) remains protected. Covered entities must enter into or 

amend written contracts with their business associates, correct or report any known 

wrongful use or disclosure of patient information made by a business associate, and 

ultimately mitigate any harm caused by such use or disclosure. These business associate provisions clearly attempt to stretch the regulatory reach of the rule by placing 

on physicians extra burdens and liabilities with respect to the privacy practices of 

those who fall outside the rule’s reach. 

The only purpose of the business associate provisions is to extend privacy protections to patient information passed on to entities not covered by the Privacy Rule. 

Yet, the chairman’s mark would already require ‘‘patient safety organizations’’ to 

maintain the confidentiality of any patient information that is disclosed to them by 

‘‘health care providers’’ in the process of reporting. Therefore, it seems unnecessary 

to also require ‘‘health care providers’’ to first negotiate a written contract with a 

‘‘patient safety organization’’ before any information is disclosed, not to mention 

placing extra responsibility and liability on ‘‘health care providers’’ for a potential 

privacy breach by a ‘‘patient safety organization.’’ This could serve as a strong disincentive to participate in a reporting system. 

We recognize that ‘‘health care providers’’ must obtain a patient authorization 

under the Privacy Rule prior to any disclosures of patient information that fall outside of treatment, payment or health care operations, unless otherwise permitted by 

the Privacy Rule. Although treating ‘‘patient safety organizations’’ as business associates and deeming their activities ‘‘health care operations’’ eliminates the need for 

prior authorization, it triggers the need for business associate agreements. We beVerDate jul 14 2003 07:07 Sep 04, 2003 Jkt 086199 PO 00000 Frm 00078 Fmt 6633 Sfmt 6621 E:\HR\OC\86199A.XXX 86199A
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lieve it would be much less burdensome for ‘‘health care providers’’ if the chairman’s 

mark could instead provide that reporting errors to a ‘‘patient safety organization’’ 

by ‘‘health care providers’’ would be a permitted disclosure under the Privacy Rule. 

This could be accomplished by providing that: ‘‘For purposes of applying the regulations promulgated pursuant to 264(c) of the Health Insurance Portability and Accountability Act of 1996 (Public Law 104–191; 110 Stat. 2033), a disclosure of patient safety data under this section made by a provider to a patient safety organization shall be treated as a permissible disclosure for public health activities for which 

an authorization or opportunity to agree or object is not required.’’ The result would 

be that voluntary reporting of ‘‘patient safety data’’ would be a permitted disclosure 

under section 164.512 of the Privacy Rule. That section provides exceptions to the 

general requirement to obtain prior authorization for a disclosure of patient information for various public health and safety purposes, including voluntary reporting 

of adverse events related to FDA-regulated products. 

The AMA is pleased that section 1183 of the chairman’s mark would place the 

‘‘Center for Patient Safety’’ under the Director of the Agency for Healthcare Research and Quality (AHRQ). This change places such Center in the appropriate government agency to conduct patient safety research and quality improvement. Congress recognizes the AHRQ’s leadership role in improving patient safety. In December 1999, the Healthcare Research and Quality Act of 1999 (P.L. 106–129) was enacted into law to reauthorize the AHRQ (formerly the Agency for Health Care Policy 

and Research). In Section 912(c) of this law, Congress directed AHRQ to conduct 

and support research and build private-public partnerships to: ‘‘(1) identify the 

causes of preventable health care errors and patient injury in health care delivery; 

(2) develop, demonstrate, and evaluate strategies for reducing errors and improving 

patient safety; and (3) disseminate such effective strategies throughout the health 

care industry.’’ We recommend that the AHRQ be consulted regarding this language, as well as the activities currently underway within the AHRQ’s Center for 

Quality Improvement and Patient Safety (CQuIPS). 

The AMA is committed to continuing and redoubling our efforts to work with Congress and our partners in the health care system to achieve a system in which patients are assured of safe, quality health care. The AMA appreciates the opportunity 

to provide our comments on the chairman’s mark to H.R. 4889 and commend Chairwoman Johnson and this committee for focusing on needed improvements in patient 

safety and quality of care.

AMERICAN

fMEDICAL GROUP ASSOCIATION

ALEXANDRIA, VIRGINIA 22314

September 9, 2002

The Honorable Nancy J. Johnson 

Chairwoman, Health Subcommittee 

House Committee on Ways and Means 

1136 Longworth HOB 

Washington, DC 20515–6438

Dear Congresswoman Johnson: 

On behalf of the American Medical Group Association (AMGA), I am pleased to 

write in support of your bill, H.R. 4889, ‘‘The Patient Safety Improvement Act of 

2002.’’ We appreciate your commitment to this critical issue and for holding this 

hearing. 

As you are aware, AMGA is an association that represents some of the nation’s 

largest and most prestigious, physician-directed medical groups organized as integrated health care delivery systems. The members of AMGA deliver health care to 

more than 50 million patients in 40 states, including 15 million capitated lives. The 

average AMGA member group has 186 physicians and 12 satellite locations. Member groups include the Mayo Foundation, the Cleveland Clinic, the Palo Alto Medical Foundation, the Henry Ford Health System, the Ochsner Clinic, the Lahey Clinic and, in your own state, the Connecticut Surgical Group. AMGA’s mission is to 

shape the health care environment by advancing high quality, cost-effective, medically safe, patient-centered and physician-directed health care. 

AMGA supports the sound provisions contained in your bill. We would request, 

however, that you further strengthen the intent of ‘‘Health Care Provider’’ under 

Definitions (Part D Section b.3). Specifically, the definition of ‘‘Health Care Provider,’’ as currently set forth in your bill under subsections (A) and (B), appears to 

be related only to those practitioners who are associated with hospitals, skilled 

76

nursing facilities, home health agencies, etc. For the sake of clarity and inclusiveness, we would request that you add a subsection that reads: 

‘‘C’’ a physician (as defined in section 1861(r) of the Social Security Act; 

‘‘D’’ any other person who is engaged in the delivery of medical or other health 

care services (as defined in section 1861(s) (1) and (2) of such Act) in a State and 

who is required by the State law or regulation to be licensed or certified by the 

State to engage in the delivery of such services in the State; 

‘‘E’’ any other person or entity specified in regulations by the Secretary after public notice and comment. 

As you know, the settings in which physicians practice have become quite varied 

and, therefore, it is important to acknowledge the demographic diversity of today’s 

medical practitioners as an integral part of your legislation. 

AMGA also applauds your clarification of key issues regarding the confidential 

and voluntary nature of the reporting and collection of patient safety data. AMGA 

strongly advocates a ‘‘. . . national, voluntary, confidential and protected reporting 

system that is non-regulatory.’’ Additionally, AMGA advocates that ‘‘public reporting 

of such events should focus on the implementation of effective safety practices and 

the means by which they may be maintained by the provider and the patient.’’

In previous forums, AMGA has conveyed the need for all health organizations to 

instill a ‘‘culture of safety’’ in order to improve upon the assurance of safety of care 

for patients. Your new bill accomplishes this concept in a legislative mode that is 

instructive, objective and responsible. 

Thank you for your continued dedication to the access, quality and reasonable cost 

of health care for our patients as well as the concomitant re-institution of professional respect and fairness for our practitioners. Please do not hesitate to let us 

know if we may be of further assistance. We look forward to working with you and 

your staff to move this bill forward. 

Sincerely yours, 

DONALD W. FISHER, PH.D. 

President and Chief Executive Officer 

Attachments 

AMGA Statement on Patient Safety 

Information on AMGA’s Initiative, ‘‘Safety Collaborative for the Outpatient Environment’’ (SCOPE) 

Cc: Members of Health Subcommittee 

American Medical Group Association 

Statement on Patient Safety 

Members of the American Medical Group Association (AMGA) are committed to 

providing the highest quality of healthcare, using advanced and proven technologies 

in a safe and effective manner. An emphasis on patient safety is a primary aspect 

of quality management processes within organized systems of care. Systems, here, 

are the imperfect consequence of human design and maintenance. We believe continuous efforts to improve processes of care in order to eliminate medical errors are 

both an absolute necessity and the responsibility of all healthcare providers. AMGA 

supports policies that promote a comprehensive strategy to improve patient safety 

by creating environments encouraging organizations to identify errors, preserve confidentiality, evaluate causes and take appropriate actions to improve on future performance. 

Furthermore, AMGA believes that methodical approaches to the prevention of injuries due to medical care hold the first promise for the prevention of adverse 

events. Strategies to prevent errors must become an integral part of the broad continuum of care improvement. This continuum presently includes methodical processes, outcomes management, patient satisfaction measurements, improved clinical 

techniques and innovations, peer review, information sharing among clinicians and 

patients and a commitment to details. Patient safety is best promoted within organizations that are vigilant and sensitive to the gravity of even the smallest error indicative of a potentially harmful process. 

Patient-oriented organizations continually improve their capacities by using error 

sensitive management as a model for improvement. Such organizations surface errors when they occur, implement recovery strategies to mitigate harm and develop 

strategies to prevent repeat occurrences. Learning derived from such organizational 

introspection promotes continuous improvements of delivered products. 

To improve patient safety, all health care organizations must instill a ‘‘culture of 

safety’’ that focuses the organization’s care processes and workforce on improving 

77

the assurance of safety of care for patients. Safety must be an explicit organizational goal that is demonstrated by the strong direction and involvement of the governance, management and clinical leadership of the organization. Meaningful patient safety programs must include defined program objectives, personnel, adequate 

budgets and regular oversight and assessment by governance. 

The standardization of treatment processes targeted to the highest quality outcomes and the avoidance of mistakes has been an integral part of AMGA’s group 

practice model of care. Examples of how AMGA members have been active in managing patient safety include: 

1. Reducing medical errors through process improvement and enhancing patient 

services as the major focus areas of quality improvement areas; 

2. Minimizing medication errors, especially common for elderly patients taking 

12–20 different daily medications, by instituting protocols for new hospital admissions and protocols for patient medication management when the patient is transferred to another facility or discharged to home; 

3. Monitoring and investigating ‘‘sentinel’’ events (adverse medical occurrences 

which are unexpected, but potentially preventable as occurrences) as an active part 

of the group’s norm in practice routines. 

AMGA believes that health care providers have a professional and ethical obligation to inform patients and their families about events that lead to adverse events 

and injuries. Furthermore, we believe that improvements in patient safety can best 

be achieved through a national, voluntary, confidential and protected reporting system that is non-regulatory. Public reporting of such events should focus on the implementation of effective safety practices and the means by which they may be 

maintained by the provider and the patient. Lastly, legislative measures emphasizing patient safety should include provisions to reform the current culture of unbridled malpractice litigation. 

In summary, AMGA advocates that: 

1. Health care organizations and their professional providers should make continuous improvements of patient safety an overt and explicit objective—This can done 

by establishing patient safety programs, including medication safety practices, beginning at the most senior levels of responsibility and including defined executive 

leadership, responsibility and oversight. 

2. Patient safety programs should:

• provide strong, clear and visible attention to safety issues; 

• implement voluntary, non-punitive systems for reporting errors and analyzing errors within their organizations; 

• incorporate well-understood safety principles such as, standardizing and 

simplifying equipment, supplies, and processes; and, 

• establish interdisciplinary team training programs for providers that incorporate proven methods of team training, such as simulation.

3. Voluntary, non-punitive protocols for reporting adverse events can most readily 

be implemented throughout entire organizations by incorporation of incentives 

structured to promote error detection and notification while minimizing punitive 

fears. 

Last updated: February 8, 2001

Statement of the American Nurses Association 

f The American Nurses Association (ANA) appreciates the opportunity to share our 

concerns about patient safety and medical errors. This issue is one of great importance to the nursing profession. As front line health care workers, nurses have substantial contributions to make in the effort to reduce health care error. ANA is the 

only full-service professional organization representing the nation’s 2.7 million registered nurses (RN), including staff nurses, nurse practitioners, clinical nurse specialists, certified nurse midwives and certified registered nurse anesthetists through 

its 54 constituent member nurses associations. ANA submits this statement as a 

supplement to our March 7, 2002 testimony to the House Ways and Means Health 

Subcommittee. On that statement, ANA made several recommendations towards reducing medical errors. 

First ANA believes it must address a crisis issue affecting all of us in the health 

care community. The nursing shortage has reached epidemic proportions. A recent 

survey by the American Hospital Association reports that hospitals are currently attempting to fill at least 126,000 vacant RN positions. The demand for nurses will 

78

increase by 25.6 percent between 2000 and 2010, this is more than 10 percent greater than the average growth across all professions. Adequate registered nurses in the 

hospitals and at the bedside 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 medical errors. 

The majority of medical errors do not result from individual recklessness, but 

from basic flaws in the way the health delivery system is organized. Stocking patient-care units in hospitals, for example, with certain full-strength drugs—even 

though they are toxic unless diluted—has resulted in deadly mistakes. Illegible writing in medical records has resulted in administration of a drug for which the patient 

has a known allergy. Our evolving and increasingly complex health care system 

often lacks adequate coordination and appropriate systems to ensure patient safety. 

Despite increasing evidence that systems fail, institutions are continuing to assign 

and emphasize individual ‘‘blame’’ for errors, misjudgements and patient dissatisfaction. Hospital systems and administrators are assuming that the appropriate way 

to deal with the complexity of errors made in the delivery of health care is to manage the workers—through oversight and discipline—as opposed to identifying and 

resolving the true problem in the spirit of partnership. ANA has long advocated for 

investigation of system changes that may result in egregious errors by individual 

practitioners, noting that health care systems have downsized, restructured and reorganized to the point where processes, initially put in place to protect the public, 

are breaking down. 

As these systems increasingly are failing to protect patients, the severity of discipline applied to individual providers for mistakes is increasing. Health care organizations must approach problem solving strategies through shared accountability 

and partnership for quality improvement. A shared accountability approach diminishes focus on individual blaming and enhances long-range process improvements. 

ANA supports the concept of a Patient Safety Organization (PSO). Such an organization would provide a focal point for safety and quality activities by focusing on 

safety issues applicable to the full range of providers and health delivery systems. 

This entity must include adequate representation by nurses and other health professionals who are the front-line individuals in patient care. 

This PSO must support research to determine what factors lead to errors. Specifically, the PSO must be charged with collecting data on organizational practices and 

other factors that may be associated with the occurrence of errors. In our current 

knowledge, no one can state with any certainty what practices could or are more 

likely to lead to errors. Some practices are more obvious than others. For example, 

bad handwriting or open stock of certain powerful drugs have been observed to be 

the cause for errors in health care delivery. Other casual factors that may contribute to health care errors may not be as apparent. For example, relationship between system errors and appropriate nurse staffing. 

Inadequate or inappropriate staffing may mean too few registered nurses, lack of 

appropriate training or orientation for an RN assigned to the unit or inappropriate 

use of unlicensed personnel. Adequate numbers of staff are necessary to reach a safe 

level of patient care services. Ongoing evaluation and bench marking related to 

staffing are necessary elements in the provision of quality care. At a minimum, the 

PSO should collect data related to: average ratio of patients to registered nurses and 

licensed practical nurses, and unlicensed personnel, measures which differentiate 

between severity of patient illness, mortality and morbidity rates, readmission rates, 

incidence of post-discharge professional care, and length of stay, in order to examine 

the relationship of these variables to occurrence of health care errors. 

Another issue that the PSO should examine is the relationship between the error 

rates and continuous hours worked by health care professionals. Just as there is 

concern about the number of hours worked by medical residents, ANA has become 

increasingly concerned by hospitals increased reliance on the use of overtime, particularly mandatory overtime, by its registered nurse staff. In today’s health care 

workplace, 16 hour shifts are becoming increasingly commonplace and 24 hour 

shifts are not unheard of. Too many hospitals have come to rely on the use of overtime as a substitute for adequate supply of staff. 

In reference to the issue of voluntary reporting the ANA supports the call for a 

nationwide mandatory reporting system under which health care systems would be 

responsible for reporting medical errors to state governments. Currently, about a 

third of all states have such a system in place. ANA would argue however that such 

a system of reporting and tracking adverse events must not only maintain data on 

when the errors are occurring, but include information on what organizational variables are responsible for the errors. 

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 

79

is at the heart of nurses’ 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. 

Current whistle-blowing laws remain a patchwork of incomplete coverage. This 

lack of 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 patients’ health and safety. In order 

to allow nurses to function as successful patient advocates, effective whistle blower 

protection for nurses who report unsafe patient care must be enacted. 

ANA strongly supports any effort that makes patient safety a coordinated focused 

element of the health care system. The establishment of safety programs must include balanced and appropriate representation of the key players and this means 

more than token nursing representation. Nurses are pivotal to improving patient 

outcomes and excellent evaluators of the work environment for deficits and solutions 

for quality improvements. There must be clear responsibility at the top levels of associations and organizations to make sure that needed practices are articulated and 

implemented. 

Madam Chairman, the membership of the ANA wishes to thank you again for this 

opportunity to comment on this important issue. We look forward to working with 

you on legislation that creates an environment that supports both the patients and 

health care providers and assures safe quality patient care.

fBIOMEDICAL METATECHNOLOGY INC. 

AMHERST, NEW YORK 14226

September 8, 2002

To: Congresswoman Nancy L. Johnson (R–CT) 

Chairman, Subcommittee on Health of the Committee on Ways and Means

Re: Testimony for hearing on legislation to reduce medical errors

To: Congresswoman Nancy L. Johnson (R–CT) 

Chairman, Subcommittee on Health of the Committee on Ways and Means

If the subcommittee is determined to drastically cut the error rate in medical 

services, it should know this fact: 

It is now technically feasible—and highly cost-effective—to cut the error rates by 

50% or more. 

In my view the only real question is whether it is politically feasible to do so. 

I always speak as an individual, not for an organization. My name is Irwin D. 

Bross. I have been a biostatistician, cancer researcher and public health scientist 

for more than half a century. I don’t include my CV because it is in Who’s Who in 

Medicine and Healthcare. 

How can we cut the error rates in medical services by 50% and thereby prevent 

much unnecessary suffering—and save many billions of dollars a year in medicare 

and health in medicaid and health insurance costs? 

The basic idea is simple: Simply exploit our existing computer and off-the-shelf 

software resources to create statewide or nationwide medical databases which would 

serve the public interest rather professional or corporate interests. 

One example will show what I mean. Here is my letter which was printed in the 

Buffalo News (9/19/2002):

Secure database is feasible for patients 

In his column, ‘‘Pursuit of privacy may interfere with patient care,’’ Dr. Mike 

Merrill said, ‘‘The privacy instinct . . . comes partly from a Puritanical shame.’’ 

In fact, the current emphasis of privacy advocates is mainly on the misconduct 

of doctors who permit confidential medical records to be used by various predators—including drug companies, marketing departments of corporations and 

other unauthorized people. The medical profession does show an interest in 

keeping patient records private when it comes to malpractice lawyers. 

Merrill is quite right when he says, ‘‘Given the informational deficiencies in 

the current health care system, adding new, more rigorous standards . . . can 

only worsen care.’’ On the other hand, correcting those informational deficiencies by providing a single, secure, state database for all patient data that 

is accessible only to authorized people would compensate for the privacy restrictions. 

A master statewide database has been technologically feasible for at least five 

years. It would save many lives in emergency situations, such as the side-effects 

80

of multiple drug interactions. Robotic programs operating within the system 

could actually prevent many such side-effects. Uploads and downloads can be 

made secure. 

Is it the privacy advocates who have successfully blocked such informational 

upgrades, or is it the doctors and the rest of the health care system?

As you can see, the basic idea really is relatively simple: Exploit our existing computer and off-the-shelf software resources to create statewide or nationwide medical 

databases which would serve the public interest rather professional or corporate interests. Use technical tricks like ‘‘data bots’’ to constantly ‘‘patrol’’ the databases and 

which look for the situations where ‘‘human errors’’ are likely to occur. When potential trouble is found, then trained paramedicals can look into it. For example, they 

can warn the primary physician when a patient is taking multiple drugs where dangerous interactions may occur. 

The legislation to do the job should (1) state that its purpose is to cut the error 

rate by at least 50% within 5 years, (2) authorize the secure databases which would 

be used for this purpose, and (3) fund at least one test database for this purpose. 

In New York State, this could be done mainly by consolidating existing databases in some area and I would estimate that it could be done for less than $20 million 

per year for a five year period. 

The subcommittee should be careful (and perhaps innovative) in seeking advice 

on cutting error rates. 

If the committee chooses to rely on lobbyists or professional groups or ‘‘do-gooder 

activists’’ for advice on computerized systems designed to cut the currently high 

error rates in medical services, it will get advice that is advantageous to these advisors rather to ordinary Americans with health problems. 

What it needs to do is to convene a panel which would act like a grand jury: It 

would consist of ordinary citizens who listen to conflicting testimony from ‘‘expert’’ 

witnesses and then use common sense to make its ‘‘verdict’’. 

In other words, any persons who may be in conflict of interest (i.e., have a special 

interest in the issue) would be excluded from the panel. This is the opposite of the 

‘‘blue ribbon’’ panels ordinarily convened for medical issues. These have rarely operated in the public interest and a different approach to getting advice is worth trying. 

My main point, however, is that if the committee wants to cut the error rates in 

medical services by 50% or more, it is now technologically feasible to do this within 

five years. 

IRWIN D. BROSS, PH.D. 

f President

LOS ANGELES, CALIFORNIA 90083–0008

September 10, 2002

Mr. Joel White 

C/O Committee on Ways and Means 

Subcommittee on Health 

1136 Longworth Office Building 

Washington, DC 20515

Re: Statement and commentary

HR 4889: Patient Safety Improvement Act of 2002

Please note that the following is being written on behalf of my father, RONALD 

LEE BONNER (1941–2000). The title of my presentation is ‘‘Gone But Not Forgotten: 

The Eradication of Dirty Lab Coat Secrets’’.

Dear Health Subcommittee: 

It is with earnest hope that by coming forward and speaking out about how this 

bill would impact me; that it would serve as a catalyst to enable other families to 

tell their stories about bad medical experiences. While my story on behalf of my father is no different than 1,000 other stories of similar note, I offer his story as just 

one example of what happens frequently without mention. 

Everyday, countless people die unexpectedly in the midst of medical treatment/

mistakes. These senseless deaths hardly register a beep or a blip on our collective 

EEG consciousness. Sure, surviving family members know when something doesn’t 

feel right about what they’re being told. However, more often than not they’re told 

their medical interpretation of the results are somehow skewed. Doctors attempt to 

console grieving relatives in terms of a Phase I, Phase II, and Phase III analysis 

of their work. Yet, all the while never completely justifying their approach to methodology to the satisfaction of the listener. 

81

1Quote taken from H.R. Bill 4889. 

2Quote taken from Section 1185 of H.R. Bill 4889. 

3 (Current) President Bush, in an earlier speech. 

4 (Former/Elder) President Bush, famous quote from the 1980’s. 

5Popular saying of the late Mrs. Sadie Ann Mike. 

Many times doctors pump themselves full of their version of a medical truth 

serum and employing tactics in a vain, emotionless attempt to explain their deadly 

actions to an unsuspecting public. Families are indiscriminately, and pointedly 

coaxed into silence for fear of reprisals or being mocked. Doctors try and make people feel uneducated and dumb against their verbose and often ethereal language. 

Over and over again this scenario is played out in sharp contrast to their starch 

white clean image of perfection. The backdrop to this whole drama is a scrim-dividing wall, separating self-described ‘‘mistake-free’’ doctors away from the inquiring 

minds of patients and their families. I urge the members of the Committee not to 

allow, ‘‘The Patients Safety Act Bill’’ (HR 4889), to become shrouded in as much 

mystery as some forms of patient healthcare. This bill must proceed in a fair and 

equitable manner for all involved; while not forgetting the very people it was meant 

to protect. 

Bill 4889 should not be thought of as a lopsided pendulum never quite swinging 

evenly in favor of patients as well as the doctors it already serves. Nor should you 

be hasty in passing the bill without some changes which I will expound upon, shortly. Gone are the days when our nation’s citizens will accept and be pacified by intellectually numbing, ‘‘broken limb’’, half-hearted excuses for doctors fateful decisions 

and false chart remarks. In order for this bill to become successful it must include 

a level of sanctioning and accountability (Proposed Change #1). One needs to include 

disciplinary action if you’re going to speak of a bill whose underlying theme is patient safety!! The public will not stand by and idly allow our loved ones to be swept 

away in a morass of ‘‘Dirty Lab Coat’’ secrets. The only way to place ‘‘systematic 

steps to reduce the incidence’’ 1 of errors is to send a clear message to the medical 

community that such miscalculations will no longer be tolerated. The best way to 

accomplish this is through corrective action. 

Contrary to what is suggested in Section 1185 of this proposed bill I think we 

should create (Proposed change #2) ‘‘methods which would constitute national practice guidelines’’.2 Other countries have them, why not the United States? The repeated squelching of critical safety errors have led and will continue to lend itself 

to the subsequent suppression and washing away of gross mistakes and errors the 

kinds of which led to my father’s death. Visualize this picture if you will: 

a) A male patient being given pregnancy and breast cancer medicine. 

b) A patient on 6 diuretics compacted with in a six-month period. 

c) For that matter a CHF patient being prescribed foot cream. ‘‘Go Figure’’ on this 

one. 

d) A patient suddenly with a need of multiple ambulance/emergency generated 

pick ups and (coincidently) having doctors involved in his case who (ironically) specialize in E.R. care (how convenient!!); when at no other time in my father’s life has 

he ever been ill enough to warrant such health scares. 

e) Psychiatric meds given to him when he openly questioned the treatment he was 

receiving, and no doctor of appropriate degreed capacity (specifically a psychiatric 

doctor) on his team. This in turn generated comments of him being in an ‘‘altered 

state of consciousness’’ to justify what was wrongfully written and assessed in his 

medical records. 

f) One medication in particular XELODA, had warnings against its continued use 

for at least 6 months prior (to prescription to my father) informing doctors of the 

mandate for immediate discontinuance. 

g) The possibility the doctors knew in advance that certain drugs would produce 

numerous readmissions thus boosting their medical intervention at almost the same 

alarming rate as his continual hospitalizations. 

h) The combination of poly-pharmacy left my father without enough blood circulating through his body to even maintain adequate oxygen flow. 

In an earlier speech our current president asked us ‘‘all to pray for this great nation of ours’’.3 His own father once said, ‘‘Read my lips’’ 4; to which my late grandmother, Sadie Mike countered with, ‘‘Hear what I say!’’ 5. To merge some of those 

same words and ideas I pray upon the members of this Committee to heed my 

words. Make no mistake. I meant every bit of what has been presented here before 

you, today. Your bill is palatable overall but some changes are in order. 

82

Thank you one and all for allowing me to present these remarks to you on this 

most important of bills. 

Very truly yours, 

f DENA J. BONNER

CENTENNIAL, COLORADO 80016

September 5, 2002

Sirs: 

I have recently retired after 30 years of medical practice in the specialty of Otolaryngology/Head and Neck Surgery. I served in a variety of roles during this time: 

Surgery Chief, Quality Assurance Committee, Chief of Medical Staff, Board of Governors, etc., etc. 

I can affirm without equivocation that the rate of medical errors resulting in severe injury or death is remarkably overstated and without validity. The Institute 

of Medicine has created a climate of fear that is devoid of validity. 

I would urge Congress to avoid making the costs of healthcare even more unacceptable by introducing even more costly regulations. 

Best wishes. 

fRICHARD E. CARLSON, M.D.

ECRI 

PLYMOUTH MEETING, PENNSYLVANIA 19462–1298

September 11, 2002 

The Honorable Phil English 

Committee on Ways and Means 

Pennsylvania—21st, Republican 

1410 Longworth HOB 

Washington, D.C. 20515–3821

Re: H.R. 4889: Patient Safety Improvement Act of 2002

Dear Congressman English: 

On behalf of ECRI, I am writing to express our strong support for HR 4889, the 

‘‘Patient Safety Improvement Act of 2002.’’ As a Pennsylvania nonprofit patient 

safety organization with over thirty years of experience, ECRI commends your leadership in recognizing the critical need for redressing patient safety problems in our 

nation’s healthcare system. ECRI runs a voluntary problem-reporting program (initiated in 1971), analyzes and investigates patient safety data, conducts evidencedbased systematic reviews, and disseminates risk reduction tools and information to 

healthcare providers. We work collaboratively with other organizations, hospitals, 

and providers on medication safety and other patient safety programs. Over the 

years, ECRI has been very successful in producing strides in patient safety—medical 

products, systems and practices have improved and injuries avoided. However, we 

remain all too aware of the longstanding barriers to problem reporting, and all too 

distressed when we see those problems repeat. Until healthcare providers are confident that their safety efforts will be used to help patients rather than hurt their 

own organizations, they will not divulge important information that can ultimately 

help to avoid another repeat performance. 

We strongly recommend that the definition of a ‘‘patient safety organization’’ include organizations like ECRI, which has been collecting voluntary problem reports 

and safety data for over three decades. Our protocols mirror many of the ones outlined in the bill. We are an independent agency, we de-identify institutions, we disseminate safety information, and we provide feedback and assistance. We also have 

strict conflict-of-interest rules. We have worked very hard to maintain the trust and 

confidence of healthcare providers. The protections offered by the bill would promote 

even better reporting to ECRI, and better analysis and data as a result. The bill 

should recognize the importance of established safety organizations with a track 

record. Otherwise, it might thwart its own goals by inadvertently chilling the dissemination of data that is currently being shared on a voluntary basis. 

ECRI provides highly regarded health technology assessment programs, issues 

numerous publications, and works on many government contracts—all of which bear 

on the safety and quality of healthcare. Our programs serve hospitals, long-term 

care facilities, government agencies, and payers across the nation as well as the 

public (see www.ecri.org for a more detailed description). We mention these other 

programs to emphasize that a patient safety organization may provide many proVerDate jul 14 2003 07:07 Sep 04, 2003 Jkt 086199 PO 00000 Frm 00086 Fmt 6633 Sfmt 6621 E:\HR\OC\86199A.XXX 86199A
83

grams and services. It is important that multifaceted activities should not preclude 

an organization from being designated as a ‘‘patient safety organization’’ under the 

Act. The current bill addresses this in Section 1181 (b) (2) by defining a patient safety organization as a private or public organization or component thereof that certifies that it conducts, as a primary activity, efforts to assist providers that report 

to such an organization. We urge you to retain this flexibility in the Act. It would 

be very distressing if an organization like ECRI, which has received thousands of 

patient safety reports and data from healthcare providers, were unable to be certified as a patient safety organization simply because its reporting program is one 

of many safety programs it operates. In fact, our interdisciplinary scope and breadth 

is an important factor in strengthening the quality of our work in patient safety. 

ECRI is available to work with Congress to address improvements in patient safety and the matters addressed in HR 4889. Please feel free to contact me at (610) 

825–6000 x5142 or Ronni P. Solomon, Esq. at (610)-825–6000 X5158. 

Sincerely, 

JEFFREY C. LERNER, PH.D. 

fPresident and Chief Executive Officer

Statement of the Society of Thoracic Surgeons 

The Society of Thoracic Surgeons, representing essentially all board certified cardiac and thoracic surgeons in the United States, strongly urges the Congress to pass 

H.R. 4889, the Patient Safety Improvement Act of 2002. 

This bill has been drafted following two years of careful study and numerous 

hearings on the ways in which Congress can best encourage hospitals, physicians, 

and other health care providers to collect and analyze adverse events and to share 

information on the means by which quality can continuously be improved. As the 

Institute of Medicine has emphasized, most weaknesses in health care are systemic 

and local; improvement requires the cooperation and participation of many individuals, and only through voluntary sharing of information is such systemic improvement possible at the local level. 

H.R. 4889 will encourage the establishment of a voluntary national database, with 

confidentiality of reporting, that will permit the Department of Health and Human 

Services to analyze non-identifiable patient safety data. The bill will also encourage 

the analysis and sharing of this information at the local provider level. The Agency 

for Health Care Research and Quality should also be intimately involved in these 

data analyses. 

The Society of Thoracic Surgeons established its voluntary National Cardiac Database (NCD) in 1989, and it has evolved into the type of analysis and feedback system for outcomes analysis that HR 4889 is proposing. The benefits of such a system, 

with analysis of data by objective professionals with the requisite medical and technical expertise, have been demonstrated by improvements in the care of cardiac surgery patients nationwide. Several state and regional cardiac surgical organizations, 

most notably the Northern New England Cardiovascular Disease Study Group have 

also demonstrated that, under conditions of confidentiality, information on best 

practices can readily be shared and analyzed within local and regional quality improvement organizations, with demonstrable improvements in medical practice. 

The Society of Thoracic Surgeons’ NCD for outcomes in cardiac surgery now includes over 1.8 million patient records. Currently, 529 institutions are submitting 

detailed data to the program. Through a partnership with the Duke Clinical Research Institute, database members are provided with site-specific risk-adjusted operative mortality, morbidity, and post-operative length of stay outcomes data. These 

feedback data permit the participating institutions to benchmark their own risk-adjusted—results against national and regional outcomes benchmarks and identify 

areas for process improvement. 

In addition to the impetus provided for systemic quality improvement at participating institutions, the NCD enables qualified researchers to identify specific surgical techniques and processes of patient care that can improve outcomes following 

cardiac surgery. 

A specific example of such a change is the increase in internal thoracic artery 

(ITA) use for primary CABG (Coronary Artery Bypass Grafting). In 1994, data from 

the STS NCD documented an overall increase in the use of ITA in the years 1989–

1994; moreover, this study confirmed that ITA grafting was associated with a significant improvement in 30-day survival after CABG. Recently, a subsequent analysis from the NCD documented that even in elderly patients > age 75 years underVerDate jul 14 2003 07:07 Sep 04, 2003 Jkt 086199 PO 00000 Frm 00087 Fmt 6633 Sfmt 6621 E:\HR\OC\86199A.XXX 86199A
84

going CABG, ITA grafting was strongly associated with decreased operative mortality (Ferguson, JTCVS, 2002). As a result of these and other studies, ITA use in 

CABG in the U.S. has increased steadily each year resulting in improved patient 

safety. This demonstrates the positive impact on outcomes that can—and has—resulted from a voluntary, confidential database. These data have been used in a national quality improvement randomized trial funded by the Agency for Healthcare 

Research and Quality (AHRQ) to the STS to promote the use of ITA grafting in the 

elderly, the results of which will be presented at the American Heart Association 

Meeting in November. Other STS led quality improvement efforts, most notably CQI 

efforts addressing the use of pre-operative beta-blockers to reduce mortality and 

morbidity following CABG, have been documented to improve CABG mortality (Ferguson, JAMA, 2002). 

We believe that it is essential that health care data developed and reported for 

the purposes of quality improvement will remain confidential, and that this is true 

for this and other physician-led efforts in error identification and quality improvement. Within the STS database, this has been achieved through a sophisticated system of de-identifying data. It is equally essential that the data must be available 

locally, where it can be most effectively used by the providers to evaluate the processes of care, and that the data analyses, both local and national, be done by an 

objective 3rd party entity with the requisite medical and technical expertise to draw 

valid conclusions. 

The STS as a medical specialty society with a documented track record in quality 

measurement and quality improvement believes that H.R. 4889 will encourage and 

facilitate greater exchange of needed patient safety and outcomes information 

throughout our nation’s health care system. The combined professional ethic to ‘‘do 

the right thing’’ combined with such a NCD system has in part contributed to an 

almost 40% reduction in operative mortality nationwide for CABG between 1990–

1999 in the US, despite an almost 40% increase in preoperative predicted surgical 

risk. We strongly support this proposed legislation and are proud that voluntary initiatives begun years ago by the Society of Thoracic Surgeons can now demonstrate 

that patient safety and outcomes reporting initiatives have directly and positively 

impacted on the safety and quality of CABG care nationwide. 

Æ