[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]



 
   MEDICAL ERRORS: IMPROVING QUALITY OF CARE AND CONSUMER INFORMATION

=======================================================================

                             JOINT HEARING

                               before the

                            SUBCOMMITTEES ON
                         HEALTH AND ENVIRONMENT

                                  and

                      OVERSIGHT AND INVESTIGATIONS

                                 of the

                         COMMITTEE ON COMMERCE

                                and the

                         SUBCOMMITTEE ON HEALTH

                                 of the

                     COMMITTEE ON VETERANS' AFFAIRS
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED SIXTH CONGRESS

                             SECOND SESSION

                               __________

                            FEBRUARY 9, 2000

                               __________

                Committee on Commerce Serial No. 106-90
            Committee on Veterans' Affairs Serial No. 106-29

                               __________

 Printed for the use of the Committee on Commerce and the Committee on 
                           Veterans' Affairs

                    ------------------------------  




                     U.S. GOVERNMENT PRINTING OFFICE
62-968 cc                    WASHINGTON : 2000


                         COMMITTEE ON COMMERCE

                     TOM BLILEY, Virginia, Chairman

W.J. ``BILLY'' TAUZIN, Louisiana     JOHN D. DINGELL, Michigan
MICHAEL G. OXLEY, Ohio               HENRY A. WAXMAN, California
MICHAEL BILIRAKIS, Florida           EDWARD J. MARKEY, Massachusetts
JOE BARTON, Texas                    RALPH M. HALL, Texas
FRED UPTON, Michigan                 RICK BOUCHER, Virginia
CLIFF STEARNS, Florida               EDOLPHUS TOWNS, New York
PAUL E. GILLMOR, Ohio                FRANK PALLONE, Jr., New Jersey
  Vice Chairman                      SHERROD BROWN, Ohio
JAMES C. GREENWOOD, Pennsylvania     BART GORDON, Tennessee
CHRISTOPHER COX, California          PETER DEUTSCH, Florida
NATHAN DEAL, Georgia                 BOBBY L. RUSH, Illinois
STEVE LARGENT, Oklahoma              ANNA G. ESHOO, California
RICHARD BURR, North Carolina         RON KLINK, Pennsylvania
BRIAN P. BILBRAY, California         BART STUPAK, Michigan
ED WHITFIELD, Kentucky               ELIOT L. ENGEL, New York
GREG GANSKE, Iowa                    TOM SAWYER, Ohio
CHARLIE NORWOOD, Georgia             ALBERT R. WYNN, Maryland
TOM A. COBURN, Oklahoma              GENE GREEN, Texas
RICK LAZIO, New York                 KAREN McCARTHY, Missouri
BARBARA CUBIN, Wyoming               TED STRICKLAND, Ohio
JAMES E. ROGAN, California           DIANA DeGETTE, Colorado
JOHN SHIMKUS, Illinois               THOMAS M. BARRETT, Wisconsin
HEATHER WILSON, New Mexico           BILL LUTHER, Minnesota
JOHN B. SHADEGG, Arizona             LOIS CAPPS, California
CHARLES W. ``CHIP'' PICKERING, 
Mississippi
VITO FOSSELLA, New York
ROY BLUNT, Missouri
ED BRYANT, Tennessee
ROBERT L. EHRLICH, Jr., Maryland

                   James E. Derderian, Chief of Staff

                   James D. Barnette, General Counsel

      Reid P.F. Stuntz, Minority Staff Director and Chief Counsel

                                 ______

                 Subcommittee on Health and Environment

                  MICHAEL BILIRAKIS, Florida, Chairman

FRED UPTON, Michigan                 SHERROD BROWN, Ohio
CLIFF STEARNS, Florida               HENRY A. WAXMAN, California
JAMES C. GREENWOOD, Pennsylvania     FRANK PALLONE, Jr., New Jersey
NATHAN DEAL, Georgia                 PETER DEUTSCH, Florida
RICHARD BURR, North Carolina         BART STUPAK, Michigan
BRIAN P. BILBRAY, California         GENE GREEN, Texas
ED WHITFIELD, Kentucky               TED STRICKLAND, Ohio
GREG GANSKE, Iowa                    DIANA DeGETTE, Colorado
CHARLIE NORWOOD, Georgia             THOMAS M. BARRETT, Wisconsin
TOM A. COBURN, Oklahoma              LOIS CAPPS, California
  Vice Chairman                      RALPH M. HALL, Texas
RICK LAZIO, New York                 EDOLPHUS TOWNS, New York
BARBARA CUBIN, Wyoming               ANNA G. ESHOO, California
JOHN B. SHADEGG, Arizona             JOHN D. DINGELL, Michigan,
CHARLES W. ``CHIP'' PICKERING,         (Ex Officio)
Mississippi
ED BRYANT, Tennessee
TOM BLILEY, Virginia,
  (Ex Officio)

                                  (ii)

  

              Subcommittee on Oversight and Investigations

                     FRED UPTON, Michigan, Chairman

JOE BARTON, Texas                    RON KLINK, Pennsylvania
CHRISTOPHER COX, California          HENRY A. WAXMAN, California
RICHARD BURR, North Carolina         BART STUPAK, Michigan
  Vice Chairman                      GENE GREEN, Texas
BRIAN P. BILBRAY, California         KAREN McCARTHY, Missouri
ED WHITFIELD, Kentucky               TED STRICKLAND, Ohio
GREG GANSKE, Iowa                    DIANA DeGETTE, Colorado
ROY BLUNT, Missouri                  JOHN D. DINGELL, Michigan,
ED BRYANT, Tennessee                   (Ex Officio)
TOM BLILEY, Virginia,
  (Ex Officio)

                                 ______

                     COMMITTEE ON VETERANS' AFFAIRS

                      BOB STUMP, Arizona, Chairman

CHRISTOPHER H. SMITH, New Jersey     LANE EVANS, Illinois
MICHAEL BILIRAKIS, Florida           BOB FILNER, California
FLOYD SPENCE, South Carolina         LUIS V. GUTIERREZ, Illinois
TERRY EVERETT, Alabama               CORRINE BROWN, Florida
STEPHEN E. BUYER, Indiana            MICHAEL F. DOYLE, Pennsylvania
JACK QUINN, New York                 COLLIN C. PETERSON, Minnesota
CLIFF STEARNS, Florida               JULIA CARSON, Indiana
JERRY MORAN, Kansas                  SILVESTRE REYES, Texas
J.D. HAYWORTH, Arizona               VIC SNYDER, Arkansas
HELEN CHENOWETH, Idaho               CIRO D. RODRIGUEZ, Texas
RAY La HOOD, Illinois                RONNIE SHOWS, Mississippi
JAMES V. HANSEN, Utah                SHELLEY BERKLEY, Nevada
HOWARD P. (BUCK) McKEON, California  BARON P. HILL, Indiana
JIM GIBBONS, Nevada                  TOM, UDALL, New Mexico
MICHAEL K. SIMPSON, Idaho
RICHARD H. BAKER, Louisiana

          Carl D. Commenator, Chief Counsel and Staff Director

                                 ______

                         Subcommittee on Health

                    CLIFF STEARNS, Florida, Chairman

CHRISTOPHER H. SMITH, New Jersey     LUIS V. GUTIERREZ, Illinois
MICHAEL BILIRAKIS, Florida           MICHAEL F. DOYLE, Pennsylvania
JERRY MORAN, Kansas                  COLLIN C. PETERSON, Minnesota
HELEN CHENOWETH, Idaho               JULIA CARSON, Indiana
HOWARD P. (BUCK) McKEON, California  VIC SNYDER, Arkansas
MICHAEL K. SIMPSON, Idaho            CIRO D. RODRIGUEZ, Texas
RICHARD H. BAKER, Louisiana          RONNIE SHOWS, Mississippi

                                 (iii)


                            C O N T E N T S

                               __________
                                                                   Page

Testimony of:
    Berwick, Donald M., President and CEO, Institute of 
      Healthcare Improvement, on behalf of Institute of Medicine.    14
    Bovbjerg, Randall R., Principal Research Associate, The Urban 
      Institute..................................................    25
    Cousins, Diane D., Vice President, Practitioner and Product 
      Experience Division, U.S. Pharmacopeia.....................    97
    Foley, Mary, President, American Nurses Association..........   137
    Garthwaite, Thomas, Deputy Undersecretary of Health, Veterans 
      Health Administration, Department of Veterans' Affairs; 
      accompanied by James Bagian, Director, National Center for 
      Patient Safety.............................................    41
    Golden, William E., President, American Health Quality 
      Association................................................   126
    Heinrich, Janet, Associate Director, Health Financing and 
      Public Health Issues, General Accounting Office............    92
    Kizer, Kenneth W., President and Chief Executive Officer, The 
      National Quality Forum.....................................    18
    Langberg, Michael L., Senior Vice President, Medical Affairs, 
      Chief Medical Officer, Cedars-Sinai Health System, on 
      behalf of American Hospital Association....................   132
    Nelson, Audrey L., Director of Patient Safety, Center of 
      Inquiry, James A. Haley VA Hospital........................    90
    O'Leary, Dennis S., President, Joint Commission on 
      Accreditation of Healthcare Organizations..................   120
    Perry, Daniel, Executive Director, Alliance for Aging 
      Research, on behalf of Foundation for Accountability.......   116
Material submitted for the record by:
    American College of Physicians--American Society of Internal 
      Medicine, prepared statement of............................   158
    American Osteopathic Association and the American Osteopathic 
      Healthcare Association, prepared statement of..............   153
    Chenoweth-Hage, Hon. Helen, a Representative in Congress from 
      the State of Idaho, prepared statement of..................   160
    Consumer Coalition for Quality Health Care:
        Letter dated February 7, 2000, to Hon. Michael Bilirakis.   161
        Letter dated February 7, 2000, to Hon. Sherrod Brown.....   162
    Health Care Liability Alliance, prepared statement of........   169
    Morella, Hon. Constance A., a Representative in Congress from 
      the State of Maryland, prepared statement of...............   162
    National Medical Concepts, Inc., prepared statement of.......   155
    Shands HealthCare, prepared statement of.....................   157

                                  (v)

  


   MEDICAL ERRORS, IMPROVING QUALITY OF CARE AND CONSUMER INFORMATION

                              ----------                              


                      WEDNESDAY, FEBRUARY 9, 2000

        House of Representatives, Committee on Commerce, 
            Subcommittee on Health and Environment and 
            Subcommittee on Oversight and Investigations, 
            joint with the Committee on Veterans' Affairs 
            Subcommittee on Health,
                                                    Washington, DC.
    The subcommittees met, pursuant to notice, at 10:30 a.m., 
in room 2123, Rayburn House Office Building, Hon. Michael 
Bilirakis (chairman of the Subcommittee on Health and 
Environment) presiding.
    Members present from Subcommittee on Health and 
Environment: Representatives Bilirakis, Stearns, Greenwood, 
Burr, Whitfield, Ganske, Norwood, Bryant, Bliley (ex officio), 
Green, Strickland, Barrett, and Towns.
    Members present from Subcommittee on Oversight and 
Investigations: Representatives Cox, Burr, Whitfield, Ganske, 
Bryant, Bliley, Green, and Strickland.
    Members present from Subcommittee on Health: 
Representatives Stearns, Gutierrez, Smith, Bilirakis, Moran, 
Snyder, and Rodriguez.
    Also present, Committee on Veterans' Affairs: 
Representatives Evans and Udall.
    Staff present: Jason Lee, majority counsel; Chuck Clapton, 
majority counsel; Ralph Ibson, majority counsel; Kristi Gillis, 
legislative clerk; Bridgett Taylor, minority professional 
staff; John Ford, minority professional staff; Karen Folk, 
minority professional staff; Susan Eddgerton, staff director; 
and Sandra McClellan, professional staff.
    Mr. Bilirakis. I want to welcome aand thank all of our 
witnesses and the members for taking the time to join us today 
for this very important hearing. As chairman of this 
subcommittee, I have conducted many hearings with other 
subcommittees and committees. I believe, frankly, in the joint 
hearing because you spend a lot less time since multiple 
committees don't have to go over material repeatedly. Today, 
however, marks my first joint hearing with the Veterans' 
Affairs Subcommittee on Health, on which I serve as vice 
chairman. And I want to extend a special welcome to my VA 
committee colleagues and particularly to the chairman of the 
subcommittee, Mr. Cliff Stearns, my fellow Floridian.
    Together we will examine the issue of medical errors in our 
Nation's healthcare system. A recent report by the Institute of 
Medicine entitled ``To Err is Human, Building a Safer Health 
System'', takes a serious look at the prevalence and causes of 
medical mistakes. During my tenure as a member of this 
subcommittee, we have constantly focused on ways in which the 
quality of health care can be improved.
    As chairman, I have appreciated the support of the 
subcommittee's ranking member, Mr. Sherrod Brown, of Ohio, and 
I regret and I know we all regret that he is unable to join us 
today. You, I am sure, all realize he had a pretty serious 
accident up in Ohio and I talked to his chief of staff 
yesterday and I understand he got out of the hospital the day 
before and is mending but it will take a while to do so.
    Last year the subcommittee approved H.R. 2506, the Health 
Research and Quality Act of 1999. This bi-partisan legislation 
was enacted into law to reauthorize and rename the Agency for 
Healthcare Quality and Research. I introduced this measure, 
joined by Mr. Brown, to refocus the agency's mission and 
promote research to improve the safety and quality of 
healthcare. America's healthcare system provides high quality 
affordable healthcare coverage to millions of Americans each 
day, but we must always continue to closely monitor the system 
and strive to make it better.
    Today's hearing is not intended to cause public alarm but 
rather to focus needed attention on real problems within our 
healthcare system. Like many people, I was deeply disturbed by 
the Institute of Medicine's recent report. It cites estimates 
that at least 44,000 and possibly as many as 98,000 deaths each 
year are the result of medical errors. This makes medical 
errors roughly the eighth leading cause, and I have even seen 
some figures which put medical errors as the fifth leading 
cause, of death in the United States. We can and should work 
together to reduce these startling figures.
    As a senior member of the Veterans' Affairs Committee, I 
have had the opportunity to review detailed information about 
ongoing efforts to reduce medical errors within the VA system. 
The VA operates an integrated national healthcare system 
providing a full range of services to eligible veterans through 
some 170 hospitals, more than 600 clinics and some 130 nursing 
homes. In 1997 a local newspaper in my congressional district 
ran a series of stories about healthcare services at the 
Department of Veterans' Affairs.
    These articles recounted mistakes resulting in the deaths 
of 23 Florida veterans. The newspaper also reported that 
another 23 deaths occurred at other VA facilities across the 
country since 1993. These deaths were caused by unusual or 
avoidable circumstances. In response I urged VA Committee 
Chairman Bob Stump to investigate this matter. The Health 
Subcommittee, which is chaired by our colleague, as I 
indicated, Cliff Stearns, conducted two hearings on the quality 
of care and patient safety at VA medical facilities during the 
last Congress.
    I was pleased to work with Subcommittee Chairman Stearns on 
these hearings and I want to commend his leadership on this 
very serious issue. Since those hearings, the VA has undertaken 
numerous initiatives to improve patient safety within its 
healthcare system. Many of the steps taken by the VA were also 
recommended in the IOM report. Our witnesses from the 
Department of Veterans' Affairs will provide valuable insight 
on their experiences in addressing these concerns.
    In June 1997, the VA ordered its hospitals to report 
medical errors, which are logged into its National Patient 
Safety Registry. Last year the VA's Office of the Medical 
Inspector used this data to report that veterans hospitals 
around the country committed about 3,000 medical errors leading 
to approximately 700 deaths between June 1997 and December 
1998, a year and a half.
    While these numbers are disturbing and must be examined, 
the VA should be recognized for its efforts to create a data 
base of adverse events which can be used to identify and 
correct system errors. In addition to the National Patient 
Safety Registry, the VA established a national center for 
patient safety to lead the department's patient safety effort. 
The VA also created several patient safety centers of inquiry 
to develop practical solutions to the patient safety 
challenges.
    And one of those inquiry centers is located at the VA 
Medical Center in Tampa, Florida, and I would like to take this 
opportunity to welcome Dr. Audrey Nelson, Director of the 
Patient Safety Center of Inquiry at the James Haley VA Medical 
Center in Tampa. This center is focused on preventing patient 
falls and promoting safe wheelchair mobility. All of our 
witnesses today will help us better understand the problem of 
medical errors, the Institute of Medicine report and its 
recommendations and related concerns, and we will also 
highlight successful private and public sector initiatives.
    As we consider these issues, our shared goal must be to 
reduce the number of medical errors and to improve protections 
for the patients in our Nation's healthcare system. And I now 
yield to Mr. Green, who is sitting in for Mr. Brown as the 
ranking member of this subcommittee. Mr. Green.
    Mr. Green. Thank you, Mr. Chairman. I am pleased that we 
are beginning to address the issue of medical errors in a non-
partisan and collaborative way. Members of the three 
subcommittees will hear witnesses representing a host of 
government, quasi government, and private organizations that 
will be giving serious thought to the issues before us.
    Mr. Chairman, a coordinated hearing is so important because 
of our joint referral and joint jurisdiction issues, and not 
only we as Members of Congress and committees have to work 
together but also our staffs need to know each other so we can 
work together for efficiency. While the question how to address 
medical errors is as old as medicine itself as we know first do 
no harm, there are still many questions to answer and many 
issues to think through.
    The complex nature of our medical system and the practice 
of medicine being an art as much as a science a solution does 
not come easily. I am pleased that the Institute of Medicine 
report has rekindled the interest in the matter but I hope the 
rush of publicity does not push us to act irrationally. We 
should have thorough analysis and assessment of the problems 
and potential solutions before we act hopefully in a very bi-
partisan manner.
    There are some activities that are going on today to reduce 
and prevent the incidence of errors in various settings with 
varying degrees of success. We should explore how we can 
buildupon these ideas and we should examine new approaches to 
developing safe systems and insuring patient safety and also 
explore what Congress can do to foster these as well. I know 
other members here share that sentiment and it is great to have 
my good colleague from Chicago next to me.
    Lois Capps, who unfortunately is unable to join us today 
because of the death of her daughter, asked that I share a 
short statement with you. Due to a death in her family, Ms. 
Capps cannot be here today. A former nurse, Ms. Capps has 
indicated her concern to me about the IOM report and the 
medical errors problem particularly as they pertain to nurses 
and patient safety. She has told me that her main concern is 
that we approach this problem not by blaming the healthcare 
professionals who make individual errors but rather that we 
address the systems that often fail our healthcare 
professionals and ultimately our patients.
    Ms. Capps is working closely with me on the medical errors 
issue and I look forward to her return to the committee so that 
we can continue this important work. I look forward to working 
with Ms. Capps and the other members of the three subcommittees 
who are here today on the topic so that we can develop a 
comprehensive effective solution to a problem that has been 
plaguing our medical system for quite some time.
    Mr. Chairman, I would like to ask unanimous consent for our 
colleague, Sherrod Brown, who again because of his auto 
accident, as you mentioned, could not be here and have it 
placed into the record. I yield back the time.
    Mr. Bilirakis. I thank the gentleman. The Chair recognizes 
the chairman of the full Commerce Committee, Mr. Bliley.
    Chairman Bliley. Chairman Bilirakis, I want to thank you, 
Chairman Upton for calling this hearing today, and I also would 
like to extend a special welcome to Chairman Stearns and the 
other members of the VA Health Subcommittee. Mr. Chairman, 
recent Institute of Medicine estimates that the prevalence of 
medical errors have highlighted an important concern that we 
all share. According to the IOM report of hospitals alone 
almost 100,000 people die each year due to medical errors.
    If nursing homes, ambulatory care centers, home health 
services and doctor offices were included estimates of the 
number of unnecessary deaths would be much higher. It is 
important that we see today's hearing as part of the 
committee's larger efforts to insure patient safety. Through 
the remainder of this session of Congress, the committee will 
continue to focus attention on improving the quality of care 
that patients receive.
    Included in this effort will be a hearing tomorrow before 
the Oversight and Investigation Subcommittee examining the 
reuse of medical devices. In addition, next month the committee 
will examine how consumers could benefit from information about 
their healthcare providers and specifically how the information 
in the national practitioner data bank may be made available to 
empower consumers choice in the healthcare marketplace.
    Today's hearing will examine many of the complex issues 
relating to the goal of reducing medical errors including 
Federal versus State controlled, liability concerns, under 
reporting of adverse events and consumers access to information 
about medical errors. An important aim of this hearing is to 
identify ways to prevent medical errors before they occur. The 
witnesses before us today bring valuable perspectives on the 
issues and problems identified in the IOM report.
    Their testimony will reflect the diversity of concerns and 
issues about reporting of adverse events and ultimately 
reducing the rate of medical errors. Stopping unnecessary 
deaths from medical errors should be after all our primary 
goal. I look forward to hearing testimony from today's three 
panels of witnesses on how this can be done, and I thank you 
for yielding me the time.
    Mr. Bilirakis. I thank you, Mr. Chairman. The Chair now 
recognizes Mr. Gutierrez of Chicago, who is ranking member on 
the Veterans Hospitals and Healthcare Subcommittee.
    Mr. Gutierrez. Thank you, Mr. Chairman. I am pleased that 
the Commerce and Veterans' Affairs committees are holding this 
joint hearing today to examine the issue of medical errors in 
the healthcare delivery system. I believe that improving 
healthcare safety is a bi-partisan issue that strongly deserves 
our attention. And I thank the witnesses for taking the time to 
be here today. I have had the opportunity to preview some of 
the witness testimony and I am troubled by some of the 
findings.
    Some of the studies cited by the witnesses claim that 
medical errors lead to the deaths of between 44,000 and 98,000 
patients per year in healthcare settings ranging from hospitals 
to nursing homes. One report states that between 3 and 4 
percent of hospital patients are harmed by the care that is 
supposed to help them. According to the report, 7 percent of 
all hospitalized patients are exposed to a serious medication 
error that either harms them or could have harmed them.
    This data suggests that we have a serious health crisis on 
our hands. However, the reports state that the majority of 
medical errors do not result from individual carelessness but 
rather can be attributed to equipment, communication designs 
and procedures. This is important to know because this 
information tells us that we must take steps to improve patient 
safety. We must make serious efforts to create a culture of 
safety where the reporting of errors is encouraged and those 
who do so will not be punished for revealing problems.
    I commend the Office of the Medical Inspector at the 
Department of Veterans' Affairs for its recent report entitled 
VA Patient Safety Event Registry. This document recorded and 
analyzed medical errors and other adverse events that occurred 
throughout the VA healthcare system for a period of 19 months. 
I am pleased that the VA has set an example for the public and 
private healthcare sectors by taking the initiative to use 
medical error data to improve patient safety at our Nation's 
veterans hospitals and facilities.
    I will soon introduce a bill that would require the 
Department of Veterans' Affairs to publish every 2 years a VA 
Patient Safety Event Registry on all medical errors. This 
information will be used to identify specific aspects of 
patient care at the VA medical centers that can be used in 
their performance improvement initiatives. Again, I thank the 
chairmen of the House Commerce and Veterans' Affairs 
subcommittees for holding what I believe is a very timely and 
important hearing today. Thank you, Mr. Chairman.
    Mr. Bilirakis. I thank the gentleman, and the Chair now 
yields to Mr. Stearns, who is not only the chairman of the 
Hospitals and Healthcare Subcommittee of Veterans' Affairs but 
also a very active member of the Health and Environment 
Subcommittee on Commerce and who yielded to Chairman Bliley 
previously. You are up, Cliff.
    Mr. Stearns. Thank you, Mr. Chairman, and I am just glad we 
are convening this hearing. I want to thank you for you 
leadership. You called me back last year in the late fall to 
talk about this joint hearing. To my knowledge and our staff, 
this is the first time we have had a joint hearing between the 
Commerce Committee and the Veterans' Affairs Committee 
subcommittee so I think this is a landmark occasion.
    The subject we take up of course is safety in medicine. Mr. 
Gutierrez has pointed out the statistics which are very 
alarming considering that during the entire Vietnam era war the 
people, men and women, that were killed there was 55,000. We 
are talking about inadvertent deaths of anywhere from 44,000 
and 98,000 in 1 year. This is an alarming statistic. So I am 
privileged to participate here with Mr. Gutierrez and others 
from the Veterans' Committee but also as a member of the Health 
Committee in standing.
    The ongoing support Congress gives to maintain the VA 
healthcare system demonstrates our commitment to meet that 
debt. It goes without saying that every effort must be made to 
insure our veterans' well-being under the VA healthcare 
program. With that concern in mind, my subcommittee, as 
mentioned earlier, held important hearings on prevention of 
medical errors in the VA healthcare system. We found that VA 
has made real progress in that effort and it is gratifying to 
see VA's work to insure patient safety being recognized as an 
example for all American medicine.
    Patient safety may well be a subject on which veterans have 
valuable lessons to share with others like other healthcare 
systems and providers. However, VA has certainly not become an 
error free zone of medical practice as is true for medicine 
generally. The VA faces serious challenges. It must improve its 
understanding of how to minimize the frequency of elderly 
patients falling. It needs to develop tools to better predict 
patients at risk of suicide. It must prevent difficult patients 
from harming others.
    In 1997 VA established a comprehensive mandatory system for 
reporting adverse events. The VA and others would agree that 
reporting is not a solution in itself. It is said to be just a 
first step to identifying the underlying problem. The question 
arises, my colleagues, can reporting provide a basis for a 
reliable ``hospital report card.'' The early data from VA 
registry on adverse events show marked variation in the 
incident of these events from place to place.
    In responding to a recent survey, which I initiated, and 
Dr. Kizer is here, who was very helpful in this matter, 19 of 
the 22 VA directors who oversee all of VA's medical facilities 
express the view that some adverse events may continue to be 
under reported by their own facilities such as in cases that do 
not result in harm to a patient. Reporting systems certainly 
have their place but we should be realistic about the 
reliability of the data they provide.
    Medicine and medical administrators are really just 
beginning to grapple with the challenges and difficult 
questions posed by the high rate of errors in the delivery of 
patient care. The error rates identified in recent medical 
literature are numbing. The situation is clearly unacceptable 
and we must not allow the complexities and difficulties it 
presents to paralyze us. Instead, I hope this hearing will help 
guide us toward the kind of fundamental changes needed to 
insure that medicine's safety record become one of America's 
best.
    In that regard, I do believe the VA has made important 
advances in patient safety and has lessons to share with all of 
us. Too often government agencies with similar missions do not 
coordinate their activities. We should not let that happen. 
Last year in reauthorizing the Agency for Healthcare Research 
and Quality, AHRQ, Congress directed AHRQ to conduct and 
support patient safety research and build private-public 
partnerships.
    I plan, Mr. Chairman, to introduce legislation to require 
AHRQ to consult with VA in developing strategies to improve 
patient safety as well as to explore greater use of such 
technologies as medical simulation systems and bar coding which 
VA has employed very effectively so I look forward to this 
hearing, and, again, Mr. Chairman, I compliment you for your 
leadership.
    Mr. Bilirakis. And I thank the gentleman. The ranking 
member of the full Veterans' Committee, Mr. Lane Evans.
    Mr. Evans. Thank you, Mr. Chairman, and I want to thank all 
the chairmen for bringing us together on this important issue. 
First, do no harm is a familiar phrase from the Hippocratic 
Oath. Most of us would like to think that our physicians and 
other medical care staff abide by this principle and that we 
are safe in our hospitals. That is why it is such a brutal 
shock for many of us to read recent press accounts and learn 
that we place ourselves at jeopardy when we enter a hospital's 
doors.
    Some studies have shown that our risk of harm from medical 
errors grows with the length of stay and with the complexity in 
our conditions and the procedures we receive. These are 
certainly troubling findings. As a ranking Democratic member of 
the Committee on Veterans' Affairs, this issue really hit home 
for me when I read that the preventable deaths in the VA 
hospitals. No one wants to hear that they or someone they care 
about has been the victim of a medical mistake.
    According to the Institute of Medicine, however, there is 
no reason to suspect that the VA is any different than the 
private sector regarding the occurrence of preventable medical 
mistakes. The VA in fact is simply reflecting the state of the 
larger healthcare system with its reports of medical errors. A 
recent study reviewing all healthcare estimated that medical 
errors are one of the top ten causes of death of patients 
admitted to hospitals.
    Mistakes throughout the medical industry are much more 
common than any of us wants to acknowledge. The VA is 
different, however, in that it is undertaking many initiatives 
to study medical errors and to improve patient safety. There is 
funding in the President's budget request for the VA in fiscal 
year 2001 to expand these efforts. The VA has done the right 
thing in disclosing its findings about medical errors at the 
risk of negative publicity, and I believe that the VA's efforts 
to improve patient safety and reduce medical errors should be 
supported and encouraged.
    The VA and the rest of the healthcare system can learn from 
the VA's efforts to improve patient safety. For instance, we 
know from the VA's data that the VA should take immediate steps 
to prevent apparently common problems such as patient falls and 
adverse drug events. It can improve efforts to restrain 
impaired patients from wandering and to address the needs of 
patients with suicidal tendencies. In short, VA is using this 
data to learn and to improve its patient care and that is what 
we should be concerned about today.
    I hope that the VA will be understood and its efforts 
replicated throughout the healthcare industry. This would allow 
healthcare providers to learn from each other and consumers can 
only benefit from greater attention to patient safety. I look 
forward now to hearing from our witnesses to learn how we can 
address these difficult issues throughout the healthcare 
system. I thank you, Mr. Chairman.
    Mr. Bilirakis. I thank you, Mr. Evans. I realize that the 
opening statements up to now have been somewhat lengthy but we 
have a long day ahead of us, three very long panels, and I 
would appreciate the cooperation of the rest of the members if 
they can keep their remarks as short as possible. The red light 
will go on in accordance with the committee rules at the 3-
minute mark. The Chair now recognizes Dr. Ganske for an opening 
statement.
    Mr. Ganske. I thank you, Mr. Chairman. I obviously will 
stay within my 3 minutes. I must say that I will try to take in 
as much of the testimony today. I do need to be on the floor 
some of the day. And I thank all the panelists for coming. You 
know, Mr. Chairman, I remember back in 1995, we had a debate on 
the floor on medical malpractice tort reform, and I was 
debating a former member of this committee, Mr. Bryant, from 
Texas, and he brought up the case of a surgeon who had 
amputated the wrong leg on a patient and wanted to know how 
could that be and should that physician be liable.
    And my position has always been that of course a physician 
should be liable for a mistake like that. How could that 
happen? How could it be that a surgeon could amputate the wrong 
leg? Well, this is where we need to look at the processes 
involved. It turns out that in this particular case the patient 
had two gangrenous legs. Both legs were gangrenous. Both would 
need to be amputated. The wrong one was taken off first. And in 
my opinion that was a serious medical error and the physician 
should be liable for that.
    By the same token, I would point out that when an HMO makes 
a medical decision that results in an injury like that the HMO 
should be liable for it. There is a case of a little boy in 
Atlanta, Georgia, who had a directive from his HMO that 
resulted in gangrene of both hands and both feet, both of which 
needed to be amputated. And under current Federal law the only 
responsibility that that health plan has is for the cost of the 
amputations. I don't think that is justice. That is what we 
need to address in the conference that we are doing on patient 
protection legislation.
    More pertinent to this testimony, I think we need to look 
at the data that the IOM report is based on. One study was done 
in 1984, another in 1992. That is 8 and 16 years ago. They were 
done in States that were not necessarily representative of a 
national average. And I think that we need to be very careful 
when we are talking about untoward results of therapy versus 
mistakes. You know, every time that I treated a patient, I told 
them that there were possible complications of treatment. They 
could get an infection. They could have all sorts of problems. 
Their tendon repair could come apart. It might not turn out 
perfect.
    And so we need to be very careful when we are talking about 
medical errors to distinguish between potential adverse results 
versus errors, because nothing turns out perfect in any 
endeavor. And then I would finish by saying this. I think that 
when we are looking at medical errors there is a real problem 
in hospitals. Nurses have been strung like a tight wire because 
managed care has put cost constraints on hospitals. They have 
cut back on RNs. RNs are now having to supervise a lot of non-
RNs to deliver care.
    When you are the only RN on the floor and you have four 
health aides who don't have your expertise and you have people 
coming at you from all different angles the potential for a 
mistake is multiplied.
    Mr. Bilirakis. The gentleman's time has expired.
    Mr. Ganske. And, Mr. Chairman, I think there are some deep 
questions involved in how our healthcare is given.
    Mr. Bilirakis. There are, and I agree with you.
    Mr. Ganske. We ought to look at that too.
    Mr. Bilirakis. Hopefully we are going to look at all those 
things. That is the idea. We certainly plan another hearing. 
This is a very significant issue. The Chair recognizes the 
gentleman from the Veterans' Committee, a very active energetic 
member of the Veterans' Committee, Mr. Smith from New Jersey.
    Mr. Smith. Thank you very much, Mr. Chairman. This is 
obviously a very, very serious topic but in hearing Dr. Ganske 
talk reminded me of a situation that my brother had. He is an 
airline pilot, former fighter pilot, meticulous to a fault. He 
went in for a torn rotator cuff and he had his wife write on 
the shoulder that was not going to be operated on, it is not 
this one.
    So I want to thank you, Mr. Chairman. I appreciate the 
opportunity this hearing presents to discuss patient safety 
issues, the recent report of the Institute of Medicine and the 
new patient safety program already underway at the VA. The 
report entitled To Err is Human, Building a Safer Health System 
suggests an issue of deep concern and of much needed nationwide 
reform. While the report is a global focus on medicine in 
general, we can certainly apply its discussion and lessons to 
the VA.
    We are looking at a national healthcare dilemma. How can we 
minimize and hopefully eliminate adverse events in a society 
which is human and therefore not error free. Across the Nation 
there are millions of diagnostic tests, thousands of surgical 
operations and hundreds of hospitalizations daily. While the 
large and vast majority of these services occur without 
incident and lay to the restoration of health never before 
possible a few procedures do lead to untoward events and may 
even be responsible for deaths.
    Still, as the GAO report will testify, little is known 
about the incidence of adverse events. As a matter of fact, it 
points out that the two studies cited by IOM, the 1992 study in 
Colorado and 1984 in New York, the 44,000 to 98,000 figure is 
an extrapolation, and I think we have to be very, very careful 
and very prudent in not reading too much into that kind of 
data.
    We need to go wherever the facts and truth take us. As GAO 
points out, we need better recordkeeping and reporting and 
hyperbole by definition is a distortion. And this may be true. 
It may understate it, it may overstate it, it may be right on 
the mark but it tells me that we need more information before 
we make sweeping generalizations about what is happening. One 
death is one too many, Mr. Chairman, and I do believe we must 
be resolute in identifying and eliminating any identifiable 
cause of provider-related mortality.
    In the New Jersey Veterans' Administration system, Mr. 
Chairman, last year 42,000 patients were seen in our two 
hospitals and six outpatient facilities. Adverse results 
related to provider error have been a concern with the New 
Jersey VA and they take that very seriously. There has been an 
ongoing review of a few cases in 1999 and thankfully none of 
them to the best of our knowledge led to patient deaths.
    I remain quite concerned about issues of delay and 
propriety of treatment that have burdened New Jersey vets as 
they sought treatment at our facilities. Over the years my 
staff and I have worked on many constituent complaints and the 
VA has worked with us to try to resolve those. And again I look 
forward to the VA's testimony about the national patient safety 
partnership and the National Center for Patient Safety, both of 
which should prove very, very effective in reducing medical 
error.
    I want to thank, Mr. Chairman, you for convening this 
hearing and again doing it in a joint way because I think that 
does help us in a synergistic way. I yield back.
    Mr. Bilirakis. I thank the gentleman. The Chair recognizes 
Mr. Strickland of Ohio.
    Mr. Strickland. Thank you, Mr. Chairman. My remarks will be 
short but I would like to say how pleased I am that the 
Committee on Commerce and Veterans' Affairs have collaborated 
to convene today's important joint hearings. Indeed, medical 
malpractice and liability are at the heart of a vigorous 
healthcare policy debate in our country. I believe we have an 
extraordinary opportunity today to learn about the root causes 
of medical errors and possibly finding methods of preventing 
them.
    I am looking forward to learning more about the 
difficulties confronting care providers, both in the public and 
the private sectors, who are working to implement effective 
discovery and disclosure policies regarding adverse incidents 
in medicine and in patient care. Many of the parties active in 
this particular piece of the health policy debate are here 
today.
    In particular, I am aware of the Veterans' Administration's 
efforts to insure patient safety and I applaud the work that 
they have done to give confidence to their care providers and 
reassurance to their veteran patients. I welcome you here today 
to talk about your concerns. I look forward to learning from 
you. Thank you for being here. I yield back.
    Mr. Bilirakis. Thank you, Mr. Strickland. Dr. Norwood, 
opening statement.
    Mr. Norwood. Thank you, Mr. Chairman. I would like to start 
by thanking all three chairmen involved in holding this 
hearing. The subject of medical errors is one that should 
involve great consideration and is very appropriate for our 
deliberation. We have all heard the statistic of the Institute 
of Medicine report that 44,000 to 98,000 Americans are killed 
every year by medical error, a staggering statistic indeed, one 
that we should be very concerned about.
    What I found intriguing was that the IOM called a medical 
error, and let me just take a second and quote from that 
report. ``For purposes of this report, the terms error and 
adverse event are defined as follows. An error is defined as 
failure of a planned action to be completed as intended, for 
example, error of execution, or the use of a wrong plan to 
achieve an aim that would be error of planning. An adverse 
event is an injury caused by medical management rather than the 
underlying condition of the patient. An adverse event 
attributable to error is a preventable adverse event. Negligent 
adverse events represent a subset of preventable adverse events 
that satisfy legal criteria used in determining negligence.''
    Mr. Chairman, to call that definition exceedingly broad is 
perhaps an understatement. A medical error could include a 
physical error made by a doctor. It could include a diagnostic 
error made by a doctor. It could include an administrative 
error made by a doctor, a pharmacist or even a hospital. I 
believe that we need to be very careful in our approach to this 
issue. Saying medical errors are a problem in healthcare and we 
would do something about them is akin to saying disease kills 
people and we should cure all diseases.
    While I am all for curing all diseases, I recognize that 
there are a multitude of diseases that each require an 
exceedingly complex solution. Mr. Chairman, we should view 
medical errors the same way. The medical error is a multi-
faceted and complex thing. We should be very leery, these 
committees should be very leery of any quick pick solutions 
that may be proposed. We need to know what problem we are 
trying to solve and if we truly expect our efforts to lead to a 
solution.
    I relate with Mr. Smith in that opinions are not 
appropriate here. Facts is what we must have. This hearing is a 
very important step. And, Mr. Chairman, I commend you for 
calling the hearing and bringing this talented group of 
witnesses together. I look forward to this testimony, and I 
will yield back the balance of my time I hope in a timely 
manner.
    Mr. Bilirakis. I thank the gentleman. Mr. Greenwood for an 
opening statement.
    Mr. Greenwood. Mr. Chairman, in the interest of hearing 
from the witnesses, I will forego an opening statement.
    Mr. Bilirakis. The Chair very much appreciates that. Mr. 
Barrett, opening statement.
    Mr. Barrett. Thank you, Mr. Chairman. I want to thank you 
also for holding this important hearing. I also want to commend 
the VA for the work it is doing in this area. It is obviously I 
think showing its leadership in trying to deal with the problem 
of medical errors. Obviously this is an important issue. It is 
one that this committee should be focusing on. My only concern 
is that we don't forget about the other portion of this debate 
and that is the debate over HMOs and decisions that are made by 
insurance companies, which almost might be human error but also 
may result in people being denied healthcare.
    And so as we move forward, I think we have to keep the 
pressure on to keep the patients' bill of rights on the radar 
screen as well. Having said that, I am interested in hearing 
from our witnesses today so I would yield back the balance of 
my time.
    Mr. Bilirakis. Thank you so much. The gentleman from 
Tennessee, Mr. Bryant.
    Mr. Bryant. Mr. Chairman, thank you. I have a prepared 
statement, which I will submit for the record. Thank you.
    [The prepared statement of Hon. Ed Bryant follows:]
Prepared Statement of Hon. Ed Bryant, a Representative in Congress from 
                         the State of Tennessee
    Thank you Mr. Chairman.
    As I was looking over some of the materials in preparation for this 
hearing, I was struck by the title of the now-famous Institute of 
Medicine report. I think it is very appropriate: ``To Err is Human: 
Building a Better Health System.''
    We are all human. We can't be perfect all the time. And the systems 
and procedures designed by humans won't always be perfect either. My 
background is in the law, and I'm quite sure I made a few mistakes over 
the course of my career--not very many, mind you--just a few. But a 
mistake in the court room is different from a mistake in the operating 
room . . . usually there is a lot more on the line in a medical 
setting.
    I want to thank the Chairmen Bilirakis, Upton, and Stearns for 
bringing us all together today to look at ways to make our health care 
system better and safer for the patients it serves. I hope we can stay 
focused on constructive solutions, without pointing fingers and placing 
blame.
    I know we have a lot of ground to cover, and I am looking forward 
to what our witnesses have to say. Thank you all for being here.
    Mr. Chairman, I yield back.

    Mr. Bilirakis. Without objection prepared statements of all 
members of the three subcommittees are made a part of the 
record.
    [Additional statement submitted for the record follows:]
Prepared Statement of Hon. Sherrod Brown, a Representative in Congress 
                         from the State of Ohio
    Thank you, Mr. Chairman. I am pleased the Commerce and Veterans 
Affairs Committees are taking time today to discuss medical errors in 
the United States, an issue as complex as it is compelling.
    I would like to thank our distinguished witnesses for participating 
in today's hearing, and commend the Institute of Medicine and the 
Committee on Quality Health Care in America (CQHCA) for providing an 
excellent analysis of this important issue.
    The statistics are alarming: Medical errors are the eighth leading 
cause of death in the United States. Each year, more than 91,000 deaths 
are attributed to these errors.
    And medical errors drain an estimated $29 billion dollars from the 
health care system each year.
    Forty-four million Americans are uninsured; there is a gaping hole 
in Medicare where prescription drug coverage should be; there are 
unjustifiable and unconscionable disparities in the health of different 
racial and ethnic groups within the U.S.; we have yet to cure cancer, 
AIDS, heart disease . . .
    We don't have $1, much less $29 billion, to burn.
    According to the IOM report, medical errors are overwhelmingly the 
result of systemic flaws, not negligence on the part of individual 
health care providers. This makes intuitive sense, and it will help 
focus efforts to bring down error rates.
    But it doesn't make the job easy. We aren't facing one problem, we 
are facing many.
    A heterogeneous array of events fall under the category of 
``medical errors:'' nosocomial infections resulting from lapses in hand 
washing; medication errors resulting from difficult-to-decipher 
prescriptions, misdiagnoses; improper treatments; contaminated blood 
products . . . each of these types of error may call for a different 
solution.
    There is no ``quick fix'' to the problem of medical errors. The IOM 
recommendations represent a practical approach. IOM recommends looking 
at the issue broadly and tailoring a set of solutions to the individual 
problems.
    The report recommends creating a National Center for Patient Safety 
within the Agency for Healthcare Research and Quality. This center 
would develop a comprehensive strategy aimed at reducing medical 
errors. They would develop national goals, a research agenda, a process 
for disseminating information to the public on a timely basis . . . 
steps that make sense.
    Along with Mr. Bilirakis, I sponsored legislation reauthorizing the 
Agency for Health Care Policy Research and modifying its mission and 
title to focus on quality. It is appropriate that this agency would 
take on the task of reducing the medical error rate.
    The President has asked relevant agencies to review and comment on 
the IOM recommendations. Again, given the complexity of this issue, 
additional guidance is appropriate and appreciated.
    I hope this hearing adds to the momentum building for actions to 
address medical errors. I also hope it drives the point home that this 
issue cannot be effectively addressed if it is treated cavalierly or 
coopted for other purposes.
    We cannot do the issue justice by tacking it on to the patients' 
bill of rights debate, nor is it appropriate to do so.
    We have deliberated over managed care reform for four years. We are 
just beginning to evaluate the medical errors issue.
    We know how to repair the flaws in managed care. Let me repeat 
that: we know how to repair the flaws in managed care. We do not know 
how to systemically reduce medical efforts. That's why we need 
hearings. That's why we need research.
    We have a remarkable health care system, not a perfect one. I hope 
we take the opportunity within the next few weeks to wrap up the 
managed care reform debate and fix what's wrong with that part of the 
system, and, with hearings like this one, begin a less protracted, but 
no less fruitful effort to dramatically reduce the incidence of medical 
errors.
    Thank you, Mr. Chairman.

    Mr. Bilirakis. Does that complete your opening statement? 
Mr. Udall, the gentleman from New Mexico, opening statement.
    Mr. Udall. I would pass so we can get to the witnesses. 
Thank you, Mr. Chairman.
    Mr. Bilirakis. Is Mr. Moran handy? He is not. Mr. 
Rodriguez.
    Mr. Rodriguez. Thank you, Mr. Chairman. Let me just 
indicate that I think that in my particular area we had an 
individual that walked out, suffered from diabetes and walked 
out of the hospital, got lost and basically died by exposure. 
And one thing that was very insensitive was the initial 
comments that were made by the hospital and that was that he 
probably went out to go drinking. And so that in itself 
bothered me a lot. And I feel very strongly that whether you 
are--whether it is a private or public sector facility, we need 
to be held responsible to the same level, the same liability 
than anyone.
    If my dad was going there, I would expect that he be 
treated with the same quality of care that he would be in the 
private sector. And I am looking forward to the testimony that 
we are going to be hearing. Thank you, Mr. Chairman. I 
relinquish the balance of my time.
    Mr. Bilirakis. I thank the gentleman. That completes, I 
believe, the opening statements. We will move right into the 
first panel consisting of Dr. Donald M. Berwick, President and 
CEO of the Institute of Healthcare Improvement, here on behalf 
of the Institute of Medicine. We welcome Dr. Berwick. Dr. 
Kenneth Kizer, President and Chief Executive Officer of the 
National Quality Forum, a gentleman who we have had much to do 
with in the Veterans' Committee over the years. I thought he 
did a terrific job in that regard and it is very good to 
welcome you here, Doctor. And Mr. Randall Bovbjerg, is that 
correct?
    Mr. Bovbjerg. Yes. Like iceberg.
    Mr. Bilirakis. Like iceberg. You don't look like you are 
going to be much of an iceberg here today. He is the Principal 
Research Associate of the Urban Institute here in Washington, 
DC. Welcome, gentlemen. I will turn on the clock to 5 minutes. 
I would appreciate it if you would do your best to limit your 
remarks to that. Of course your written statements are a part 
of the record and hopefully you can compliment those in some 
way. Dr. Berwick, we will kick off with you.

 STATEMENTS OF DONALD M. BERWICK, PRESIDENT AND CEO, INSTITUTE 
OF HEALTHCARE IMPROVEMENT, ON BEHALF OF INSTITUTE OF MEDICINE; 
 KENNETH W. KIZER, PRESIDENT AND CHIEF EXECUTIVE OFFICER, THE 
  NATIONAL QUALITY FORUM; AND RANDALL R. BOVBJERG, PRINCIPAL 
            RESEARCH ASSOCIATE, THE URBAN INSTITUTE

    Mr. Berwick. Thank you, Mr. Chairman, and good morning, 
distinguished members of the three subcommittees, I am Don 
Berwick. I am a pediatrician and President and CEO of a non-
profit education and research organization called the Institute 
for Healthcare Improvement. I am also Clinical Professor of 
Pediatrics at Harvard Medical School. I have the privilege of 
serving on the Institute of Medicine committee that issued this 
report. I also chair the National Advisory Council of the 
Agency for Healthcare Research and Quality.
    Let me first mention the patient safety report is the first 
in a series of reports. The IOM committee will be issuing 
further reports later this year on other issues in improving 
quality of care in the country but we chose to report on 
improving safety first because it seems so fundamental. I would 
like to highlight six key findings of our committee's report.
    First, as several members have already stated, we find that 
American healthcare is unacceptably unsafe today. About 3 to 4 
percent of hospitalized patients we believe are harmed by care 
and about six or seven out of every 100 hospital patients are 
exposed to a serious medication error. I believe the mortality 
figures of 44,000 to 98,000 are defensible, that is, correct, 
and bracket the likely hazard in the country as a whole.
    We also note that we have almost no information on safety 
problems outside hospitals so we don't know what the figures 
look like in ambulatory care, office-based surgery and so on, 
but we suspect hazards in those settings are also common. Our 
second finding is that these errors and threats to patient 
safety are generally not due to flaws like carelessness or 
incompetence in individual doctors or nurses or other 
healthcare workers. People don't want to make errors. They try 
hard not to.
    The vast majority of these errors, something probably in 
the range of 95 to 98 percent, are what we call system errors 
attributable to characteristics of equipment, job designs, work 
circumstances, communications, and so on. Think about it this 
way. If we fired every healthcare worker who was involved in an 
error and substituted a new person our future error rates would 
hardly change at all. Blame won't help.
    One implication of this system's view of errors is that the 
accountability for safety has to lie with people who organize 
and run systems, board of trustees, executives and clinical 
leaders. We can't blame the individuals and hold them 
accountable for making the system safer on their own.
    Our third finding is that we can do something about the 
problem. There is a long history of scientific research bearing 
on safety, research that has been well used in other industries 
to make their systems far safer. Healthcare has not done that. 
We haven't used that research. We believe that as a national 
target if we harness the knowledge that is available we could 
aim for a 50 percent reduction in patient injuries from 
healthcare over the next 5 years.
    Fourth, it is important to understand that improving safety 
will require a cultural change in healthcare. To reduce errors, 
we have to be able to talk about errors. We have good research 
that doctors and nurses and others in healthcare are quite 
frightened to reveal the errors that they see and know about 
whether patients are harmed or not. We are going to have to 
change that. That is in distinct contrast to the aviation 
industry, which has made a serious effort to create a culture 
of safety in which discussing and reporting errors is rewarded 
and valued and the people making those reports know that they 
won't be punished for reporting what they observe.
    The Veterans' Administration has shown us that this is 
possible in healthcare also. Our committee recommends 
widespread use of blame free reporting systems in healthcare 
but we feel voluntary reporting systems aren't enough. We have 
discovered widespread distrust by the public and the lack of 
transparency of the healthcare system today, and so we have 
made a fifth recommendation, that all health care organizations 
should be required to report to State officials some forms of 
patient injury, a very limited number of serious sentinel 
events like unexpected deaths, wrong-side surgery, and deaths 
from medication errors.
    We are not recommending a large Federal bureaucracy. We 
only recommend that the Federal Government establish some 
standards for mandatory reports of sentinel events to States. 
We don't think in general those reports should identify 
individual doctors or nurses. We know this recommendation for 
mandatory reporting is controversial. If we overdo it then 
indeed mandatory reporting would chill the much more important 
voluntary reporting systems. On the other hand, we have enough 
public concern about accountability that we are concerned 
without some form of mandate we can't reassure the public.
    Our sixth recommendation is for a research, development, 
and communication center, a National Center for Patient Safety, 
to accelerate pace of learning and the spread of good ideas 
about how to make care safer. We are recommending an investment 
initially of $35 million in such a center, which might 
appropriately be housed in the Agency for Healthcare Research 
and Quality. So to summarize in terms of Federal action 
implications for our report, first we recommend a firm national 
commitment to improving patient safety dramatically and 
promptly.
    Second, we recommend funding a National Center for Patient 
Safety. Third, we recommend Federal standards for minimum 
content and format for mandatory reports of a very limited 
number of sentinel events by organizations to States. Fourth, 
we recommend extending peer review protections to voluntary 
error reporting systems that are developed by healthcare 
organizations. And, finally, we do recommend an annual report 
to you and others by the Agency for Healthcare Research and 
Quality on the state of patient safety. I would like to make 
two final personal comments that go beyond the finding of the 
IOM.
    Mr. Bilirakis. If you could do it quickly, sir, because the 
time has expired. Please proceed. Go ahead.
    Mr. Berwick. I am a little concerned that the Institute of 
Medicine committee did not have time to address two issues. The 
first is the requirement that organizations inform patients and 
families of serious injuries and errors in their care. The 
system thinks it does that but we have evidence that it doesn't 
happen routinely. The VA does have such a requirement and I 
think they set an exemplary standard.
    The second is the knotty issue of tort reform. We know that 
healthcare organizations have been able to establish voluntary 
reporting systems effectively without changes in the tort 
system. However, I strongly believe that a movement toward a no 
fault environment for malpractice litigation would help 
increase safety-oriented activity immediately. I am very 
excited by the attention that this problem is getting. After 20 
years of working on the quality arena in healthcare, I think we 
have a tremendous opportunity to make people safer in this 
country. Thank you.
    [The prepared statement of Donald Berwick follows:]
Prepared Statement of Donald Berwick, President and CEO, Institute for 
     Healthcare Improvement on Behalf of the Institute of Medicine
    Good morning, Mr Chairman and distinguished members of the three 
Subcommittees.
    My name is Donald M. Berwick. I am a pediatrician and President and 
CEO of a non-profit education and research organization called the 
Institute for Healthcare Improvement, and also Clinical Professor of 
Pediatrics and Health Care Policy at the Harvard Medical School. For 
the past two years, I have served on the Institute of Medicine's 
Committee on Quality of Care in America, which is the group that issued 
the report on patient safety, To Err Is Human.
    The patient safety report is the first in a series. The Institute 
of Medicine Committee on Quality of Care in America is continuing its 
work, and will this year issue several further reports and 
recommendations on how to address serious deficiencies in the quality 
of care. We chose to report on improving safety first, because it seems 
so fundamental and urgent. I must say that I hope our future reports 
will get as much attention as this one has.
    In the next few minutes, I would like to summarize the findings of 
the IOM Committee, and then to point out specific implications for 
Federal action.
    Our report has six key findings. First, we find that American 
health care is unacceptably unsafe today. Between three and four 
percent of hospital patients are harmed by the care that is supposed to 
help them. Out of every 100 hospitalized patients, seven are exposed to 
a serious medication error that either harms them or could have harmed 
them. We estimate that between 44,000 and 98,000 Americans die in 
hospitals each year as a result of errors in their care. If the actual 
number is 44,000, this is the eighth leading cause of death in America. 
If it is 98,000, errors are the fourth leading cause of death. We note 
that almost all the information on safety that we have is about 
hospitals; we know far too little about other areas of care, like 
nursing homes, home health care, office based care, ambulatory surgery, 
and so on. Our Committee suspects that hazards in these areas are also 
common.
    Second, we find that errors and threats to patient safety are 
generally not due to flaws like carelessness or incompetence in 
individual doctors, nurses, and other workers. People don't want to 
make errors, and they try hard not to. The vast majority of errors in 
medical care--perhaps 95% to 98%--are what we call ``systems errors,'' 
by which we mean that they are characteristics of the equipment, 
procedures, job designs, communication systems, and so on that support 
safe work, or ought to. Put another way, if we simply fired every 
health care worker who was involved in errors, and substituted a new 
person, our future error rates would not change at all. Blame won't 
help. Only system changes can help.
    One implication of a systems view of error is that responsibility 
for safety lies with the people who organize and run those systems--
executives, clinical leaders, Boards of Trustees. It is they, and not 
the individual doctors and nurses, who can do the most to make patients 
safer.
    Third, our report finds that we can do something about safety. 
There is a long history of great scientific research on causes of 
errors and ways to prevent them. Other industries rely on these 
sciences--human factors engineering, human psychology, industrial 
engineering, and others--to make their systems safer. Health care has 
not done so. Our Committee believes that, if we get smart about using 
what we know about safe designs, we can make patients much safer 
immediately. If we go further, and organize the right research on safe 
designs for health care, we can drive hazards to even lower levels. As 
a national target, we suggest for starters that we aim for a 50% 
reduction in patient injuries from health care over the next five 
years.
    Fourth, we find that improving safety will require cultural change 
in health care. To reduce errors, health care needs to know about and 
discuss its own errors. Today, we generally don't do that. We have good 
research that shows that doctors, nurses, and others in health care are 
frightened to reveal the errors they see and know about, whether 
patients are harmed or not. As a result, many health care organizations 
sincerely believe their error rates to be far lower than they actually 
are. The problem has been driven underground because people are afraid 
to talk about it, and therefore health care has trouble learning about 
hazards and preventing them.
    Contrast that with the aviation industry, which has made a serious 
effort to create a culture of safety, in which reporting errors is 
rewarded. The voluntary Aviation Safety Reporting System, run by NASA 
for the FAA, collects over 30,000 reports a year from pilots, air 
traffic controllers, and others. The people making these reports know 
that they will not be punished in any way for revealing problems, and, 
in fact, if there was no criminal activity or serious injury, the very 
act of reporting protects them legally from possible prosecution or 
punishment. We still have plane crashes, but aviation is 10 to 20 times 
safer today that a few decades ago, because it has information on its 
hazards.
    Our Committee recommends widespread use of blame-free reporting 
systems, much like ASRS, by organizations and, where helpful, others. 
This would be a major change from the status quo.
    But, we think, voluntary reporting systems are not enough. We find 
widespread distrust by the public in the lack of transparency of the 
health care system today. The public thinks we are hiding our flaws 
from them, and, in some ways, we are.
    To improve public trust, we make a fifth recommendation--that all 
health care organizations should be required to report to state 
officials some forms of patient injury--a limited number of serious 
sentinel events, such as unexpected deaths, wrong-side surgery, and 
deaths from medication errors. In fact, we think that about 22 states 
have some form of mandatory reporting already, but these state systems 
at the moment lack consistency in definitions and reporting methods, 
and therefore we have a lot of trouble learning from the reports. In 
addition, few states have invested anything like the needed resources 
in analyzing the reports they get. The aviation system assigns highly 
experienced pilots to reviewing those 30,000 reports, and that is why 
ASRS can learn so much.
    We are not recommending a large Federal bureaucracy. We recommend 
only that the Federal government establish some standards for mandatory 
reports of sentinel events to states. We also do not think that 
mandatory reports should identify individual doctors and nurses; these 
would be reports by organizations to states that events have occurred 
and what is being done about them.
    We know that our recommendation for mandatory reporting is 
controversial. If we overdo it, then a severe mandatory system could 
chill the development of the more important voluntary systems. On the 
other hand, we do not think that a voluntary system, alone, is 
sufficiently responsive to the public's concerns about accountability. 
We need to find the right balance between a system for learning--which 
has to be voluntary--and a system for public accountability--which has 
to have mandatory elements.
    Our sixth recommendation is for a research, development, and 
communication center--a National Center for Patient Safety--to 
accelerate our learning and spread of good ideas about improving 
safety. We don't have anything like that now, and, as a result, we have 
neither an organized national research agenda nor an easy way to let 
hospitals and health care systems learn about how to get safer. 
Aviation has the NASA-Ames center, which includes some of the best 
research in the world on aviation safety. Our Committee recommends an 
initially modest investment--$35 million--in such a Center, and our 
initial suggestion is that the Agency for Health Care Research and 
Quality may be a good home for it.
    To summarize our findings, especially with regard to helpful 
Federal actions, we recommend:

1. A firm national commitment to improving patient safety dramatically 
        and promptly;
2. Funding of a National Center for Patient Safety at an initial level 
        of $35 million per year;
3. Federal standards for minimum content and format for mandatory 
        reporting of a very limited number of sentinel events by 
        organizations to states;
4. Extension of peer review protections to voluntary error reporting 
        systems developed by health care organizations;
5. Annual reports by the Agency for Health Care Research and Quality on 
        the state of patient safety in America, to track our progress.
    I would like to make two final personal comments that go beyond the 
findings of the IOM Committee.
    First, discussions of mandatory reporting have focused largely on 
the need for reports by organizations to state agencies. I think there 
is an additional mandatory reporting issue that the IOM did not 
address, but that is equally important; namely, the requirement that 
organizations inform patients and families of serious injuries and 
errors in their care. Most people in health care would regard this as 
an ethical duty, but, in fact, we do not have evidence that this 
happens routinely. I think we need to promise and assure that this 
happens. The Veterans Health Administration does have such a mandatory 
standard, and I think it ought to be a model for us all.
    Second, the IOM Committee did not have the time or resources to 
explore the knotty problem of malpractice liability and tort reform. 
Many in health care say that the threat of malpractice suits makes 
secrecy necessary, and keeps organizations and individuals from talk 
openly about errors. To some extent, this is simply an excuse to avoid 
tackling the problem of safety; I know that because there are now many 
organizations that have begun to change their internal cultures without 
any change in the tort system. On the other hand, I believe strongly 
that movement toward a no-fault malpractice litigation system would 
help increase safety-oriented activity immediately. Furthermore, if we 
really believe that most patient injuries come from systems, not 
individual people, then we ought to fix the responsibility where it 
belongs: with health care organizations and enterprises.
    I have been working on quality of care issues for over two decades, 
but I have never before seen such a tremendous opportunity for 
improvement as we now have due to public attention to the issue of 
patient safety. If we act promptly and with courage, literally millions 
of future patients will be saved the pain and risk of injury from 
errors in their care.
    Thank you for this opportunity to testify. I would like my 
statement put in to the record. I would be happy to answer any 
questions the Committee may have.

    Mr. Bilirakis. Thank you very much, Doctor. Dr. Kizer, you 
are on, sir.

                  STATEMENT OF KENNETH W. KIZER

    Mr. Kizer. Thank you. Good morning, Mr. Chairman, members 
of the subcommittee. I am Dr. Ken Kizer. I am President and CEO 
of the newly formed National Quality Forum, which is a private 
non-profit membership organization that is committed to 
improving the quality of healthcare through improving the way 
that quality is measured and reported. I am pleased to be here 
today to discuss the need to improve the quality of healthcare 
in the United States in general and the especially urgent need 
to improve patient safety in particular.
    I think for too long the topics of patient safety and 
medical error have escaped public scrutiny. At the outset I 
think we should acknowledge that in the latter part of the 20th 
Century healthcare has become one of the most complex if not 
the most complex of all human activities so it really is not 
surprising that errors would occur in healthcare when you 
consider the number of interactions between people, the number 
of interactions between complex technology much of which has a 
potential to cause harm as well as to help patients.
    If there ever were a high risk, high hazard activity, I 
think modern healthcare certainly qualifies as such although it 
is not generally viewed that way. I am always reminded when I 
think of this of Mr. Gutierrez's response a couple years ago of 
how he viewed sitting in the doctor's office versus getting on 
an airplane. You can comment on that perhaps. While it is not 
surprising that modern healthcare is a high risk, high hazard 
activity, I think perhaps what is surprising is that healthcare 
has lagged so far behind other high risk activities in 
systematically implementing risk reduction and error prevention 
strategies, and I think that really is the essence of what we 
are here to talk about today.
    Now in the interest of time, I am going to defer most 
comments. You have my written statement where I discuss some 
issues related to healthcare quality in general, the genesis 
and the activities of the forum and make ten recommendations 
with regard to action that we believe could improve patient 
safety and reduce medical errors. I would just underscore a few 
of those activities and preface it by saying that despite the 
prevalence and the cost of medical errors most healthcare 
executives, clinicians, boards of trustees and consumers are 
largely unaware of the prevalence and the magnitude and the 
cost of these therapeutic adverse events and this is largely 
due to systematic under reporting of such events and the name 
and blame culture as it has been called that discourages 
reporting and the open discussion of these.
    In that regard, I think as a first priority in addressing 
this issue, we need to get more complete data on these events. 
Certainly foundational to any improvement effort is defining 
the nature that the scope of the problem and we have much work 
to do in that regard with regard to medical errors. The 
Institute of Medicine has recommended that a national mandatory 
reporting system be established that provides for the 
collection of standardized information about a set of adverse 
events, those that result in death or serious harm to patients, 
and also they recommended that the National Quality Forum be 
tasked with promulgating and maintaining a core set of 
reporting standards.
    The IOM has further recommended that Congress pass 
legislation to extend peer review protections to the data 
related to patient safety and quality improvement that are 
collected and analyzed and used solely for purposes of 
improving safety and quality. I support those recommendations 
and would strongly underscore the need for having a non-
punitive approach to gaining this data that is so much needed.
    I think I would also underscore the need for making patient 
safety a priority in the government programs that support 
healthcare as well as within healthcare organizations and for 
healthcare executives and at all levels throughout 
organizations in making or reducing medical errors and 
improving patient safety should be key strategic objectives for 
all of these entities. We would also support the IOM's 
recommendation that there be a National Center for Patient 
Safety established.
    Quite simply, if this issue is going to be addressed it has 
to have a home and it has to have people that are accountable 
for collecting the data and analyzing the data. Now where that 
home resides is something that we would defer to the Congress 
and the administration on but certainly there has to be some 
infrastructure to support the effort if it is going to be a 
priority.
    Finally, I would just comment on two other areas. There is 
much that could be done today. There is an effort or a need to 
support efforts to implement best practices and patient safety 
today. There is much that can be done. Recommendations have 
been made by a variety of entities that should be put in effect 
immediately. However, there is also gaps in our knowledge, 
substantial gaps in our knowledge, that need to be addressed by 
research and there is a need for research to find safer ways of 
providing care, for ways of communicating harm or information 
about potential risks and harm, and I would hope the Congress 
would be supportive of a research agenda in this regard as 
well. Thank you.
    [The prepared statement of Kenneth W. Kizer follows:]
Prepared Statement of Kenneth W. Kizer, President and CEO, The National 
                             Quality Forum
    Mr. Chairman and Members of the Subcommittees, I am pleased to 
appear before you today to discuss the very important public health 
need to improve the quality of U.S. healthcare in general and the 
urgent need to improve patient safety in particular. For too long, the 
topics of patient safety and medical error have escaped public 
scrutiny.
    It should come as no surprise to anyone that errors occur in 
healthcare, for in the past fifty years healthcare has become one of 
the most complex of all human activities, typically involving hundreds 
or even thousands of interactions between people and technology--even 
during ``routine'' treatments. Numerous physicians, nurses and 
technicians are involved in the care of almost every patient; myriad 
diagnostic tests are routinely performed, many of which may be 
hazardous to the patient; and treatment often involves complicated 
invasive procedures that could injure a patient in multiple ways. If 
ever there were a high risk, high hazard activity, modern healthcare 
certainly qualifies as such. Indeed, given the complexity of modern 
healthcare and the paucity of systematic efforts to reduce medical 
care-related errors, it is, in some ways, surprising that errors do not 
occur more frequently than they do.
    Therefore, Mr. Chairman, I commend you and the Subcommittees for 
focusing on this important issue, and I welcome the chance to share 
with you some thoughts about policies and practices that might be 
employed to improve patient safety and the quality of U.S. healthcare 
and possible roles that the National Quality Forum might play in such 
efforts.Healthcare Quality in the U.S.
    The quality of healthcare in the United States presents a paradox. 
On the one hand, the high level of training of U.S. healthcare 
practitioners today, our extensive and highly sophisticated biomedical 
research program, the rapid dissemination of new medical knowledge, the 
extent of government funding for healthcare, and the widespread ready 
availability of state-of-the-art diagnostic and treatment technology 
have brought life-saving treatments to more Americans than ever before 
and are the envy of much of the world. On the other hand, a number of 
studies in recent years have documented serious and widespread quality 
of care problems in U.S. healthcare. Overuse, underuse and misuse of 
medical care occur too frequently in all types of healthcare delivery 
systems and with all types of healthcare financing.
    While tens of millions of Americans reap the benefits of modern 
medicine each year, millions of others are exposed to unnecessary risks 
or are denied opportunities for improved health. Likewise, too many 
patients are injured or killed as a result of medical errors and 
therapeutic mishaps.
    Quite simply, as good as American healthcare is, it could be 
markedly better!
    Further, many experts believe that U.S. healthcare, which is by far 
the world's most expensive healthcare, could be significantly cheaper, 
if as much attention were focused on improving the quality of 
healthcare as was done in other U.S. industries in the latter part of 
the 20th century. Almost certainly, higher quality healthcare would 
cost less.
    It is notable that interest in rigorously determining the quality 
of healthcare in America is only of relatively recent origin, arising 
largely in response to the managed care revolution and concern that the 
new healthcare organizational structures and reimbursement strategies 
brought by managed care might be creating incentives that were 
deleteriously affecting the quality of care. In evaluating this 
situation, however, the most striking finding is how little is really 
known about the quality of healthcare in America. (Not that it is known 
to be better any place else.) There is no mandatory national reporting 
or surveillance system, nor any regular systematic review of the state 
of healthcare quality to determine whether it is getting better or 
worse. Likewise, few healthcare systems or provider organizations even 
have rudimentary organized data systems that routinely inform them 
about the quality of care they provide.
    Overall, it is highly ironic and quite remarkable that we know much 
more about the quality of airlines, automobiles, televisions and 
toasters in America than we do about healthcare, the nation's largest 
enterprise accounting for more than $1 trillion in annual expenditures 
and some 15% of the gross national product.
    In recognition of these problems and in response to growing 
consumer and purchaser demands for greater healthcare accountability, 
numerous efforts have been launched in the last 10 to 15 years to 
promote quality improvement in American healthcare. And while 
incremental progress has been made, in the aggregate, despite the good 
work of many dedicated individuals and organizations, healthcare 
quality has not progressed to where it can and should be. There 
continues to be large gaps between the care people should receive and 
the care that they actually do receive.
    This sentiment was clearly expressed in three independent reports 
published in 1998--i.e., reports by the National Academy of Sciences 
Institute of Medicine's National Roundtable on Health Care Quality, by 
investigators at RAND after an extensive review of the literature, and 
by the President's Advisory Commission on Consumer Protection and 
Quality in the Health Care Industry. Indeed, 1998 will probably come to 
be viewed as a watershed year for healthcare quality improvement 
because of these reports and actions they spawned.
                       the national quality forum
    One of the sequels to the 1998 reports and one of the most notable 
of recent efforts to improve the quality of American healthcare has 
been the establishment of The National Forum for Health Care Quality 
Measurement and Reporting, a private, non-profit, membership 
organization proposed by the President's Advisory Commission on 
Consumer Protection and Quality in the Health Care Industry.
    The concept of the National Quality Forum arose in recognition of a 
strong American sentiment against government regulation and control of 
healthcare quality. Of note, the Commission proposed a public-private 
partnership involving two new organizations--a private-sector entity 
they referred to as the National Forum on Health Care Quality 
Measurement and Reporting (better known now as The National Quality 
Forum [NQF]) and a public entity they called the Advisory Council for 
Health Care Quality. The Commission's original vision was that the 
Advisory Council would identify national goals for quality improvement 
and provide oversight on the accomplishment of those goals, while the 
NQF would devise a national strategy for measuring and reporting 
healthcare quality that would advance the identified national aims for 
improvement. This paired public-private relationship seemed to 
reasonably balance the concerns about the capacity of a private 
organization to meet important public needs against the negative 
sentiment towards vesting healthcare quality control with the 
government.
    The NQF was birthed in the fall of 1999, following the work of the 
Quality Forum Planning Committee that was launched in June 1998.
    With in-kind support from the United Hospital Fund of New York, the 
Planning Committee drafted an initial mission statement for the NQF, 
proposed a governance structure and sought funding from selected 
foundations. Start-up funds were subsequently obtained from the Robert 
Wood Johnson, California HealthCare and Horace W. Goldsmith Foundations 
and the Commonwealth Fund. A president and chief executive officer was 
hired in the fall of 1999, and the NQF started to operate in late 1999.
    Of note, no action has been taken, so far, to establish the 
proposed Advisory Council for Health Care Quality, and some of its 
envisioned functions are now being reviewed by the NQF for 
implementation.
    The NQF sees its fundamental mission as being the improvement of 
healthcare quality--e.g., to promote delivery of care known to be 
effective; to achieve better health outcomes, greater patient 
functionality or a higher level of patient safety; or to make care 
easier to access or a more satisfying experience. The primary strategy 
the NQF will employ to accomplish its mission is to improve quality 
measurement and reporting mechanisms--i.e., to improve the technology 
for measuring and reporting quality. In doing so, however, the NQF does 
not envision itself developing quality indicators or measures de novo. 
There are myriad other research, accreditation and oversight 
organizations and commercial interests already involved with developing 
measures.
    The NQF has identified five key enabling objectives. These include:

(1) Developing a national strategy for measuring and reporting quality 
        for the U.S. that is consistent with identified national goals 
        for quality improvement;
(2) Standardizing the measures of and processes for reporting quality-
        related data so that data collection is consistent and less 
        arduous for healthcare providers, and so that the data are of 
        greater value;
(3) Promoting consumer choice by building consumer competence in using 
        quality measures;
(4) Enlarging the healthcare system's capacity to evaluate and report 
        on the quality of care; and
(5) Increasing the overall demand for healthcare quality data.
    While there is much that needs to be done in each of these areas, 
the Forum sees a particularly acute need to reduce the burden and 
increase the value of quality reporting methods.
    The NQF has convened a group of highly respected quality 
improvement, healthcare delivery and policy experts to help craft a 
strategic framework for healthcare quality measurement and reporting. 
This group is known as the Strategic Framework Board (SFB), and its 
essential mission is to determine the principles, intellectual 
framework and criteria for quality measurement and reporting.
    In pursuing its mission, the NQF will seek to provide a clear, 
coordinated and coherent over-arching strategy and a set of guiding 
principles to inform the choice of measures that it will ultimately 
endorse. The NQF will strive to endorse measures that are compelling 
and causally related to better outcomes, and especially outcomes 
related to processes or activities that improve something that actually 
happens to patients. Indeed, the NQF believes that the true test of a 
quality indicator or measure is how well, and for what cost, the 
measure and its reporting actually helps improve care. The more ways 
that a measure promotes better outcomes, the better.
    The NQF will also strive to ensure that its over-arching strategy 
has a sound theoretical framework that will inform and guide a 
strategic and proactive research agenda.
    In approaching its work, the NQF will explore issues of quality 
across the entire spectrum of healthcare and will seek to coordinate 
quality measurement between and among the various levels or elements of 
the system-- e.g., health plan, hospital, medical group, nursing home, 
individual practitioner, home care etc.
    Likewise, the NQF believes that it must always ensure that the 
consumer's perspective is heard during the discussion of quality 
measures. In an effort to continuously actualize this, the NQF's Board 
of Directors is designed to have a majority of its members representing 
consumers and purchasers. This is an important structural precept that 
should facilitate keeping the consumer's perspective ever present.
    Finally, in approaching its work, the NQF is committed to working 
constructively with the many other parties involved in the healthcare 
quality measurement and reporting area, including especially the Joint 
Commission on Accreditation of Healthcare Organizations (JCAHO) and the 
National Committee for Quality Assurance (NCQA), to make certain that 
its work is not duplicative, but rather collaborative and helpful to 
the important work already begun by these entities. Improving 
healthcare quality is a matter of national importance that requires all 
of us to work together; there is neither time nor resources to pursue 
any strategy other than one of complete cooperation.
                   medical errors and patient safety
    Recently, as a result of the Institute of Medicine's seminal report 
on the subject in November 1999,1 considerable public 
attention has been focused on medical errors and other diagnostic or 
treatment-related mishaps that endanger patient safety--these will be 
further referred to here collectively as ``therapeutic adverse 
events''. Indeed, the evidence is clear that therapeutic adverse events 
kill tens of thousands and injure or disable hundreds of thousands of 
Americans every year. They are a major public health problem that 
warrants immediate and decisive action, and the urgency for action is 
heightened by the fact that, in many cases, solutions to prevent their 
occurrence are known. In other cases there is a need for research to 
find the best practices that would prevent their occurrence.
---------------------------------------------------------------------------
    \1\  Institute of Medicine. To Err is Human: Building a Safer 
Health System. Washington, DC. National Academy Press. 1999.
---------------------------------------------------------------------------
    Importantly, while therapeutic adverse events are just a subset of 
the larger healthcare quality problem, they are especially important 
since ensuring patient safety is an ethical imperative for healthcare 
professionals individually and collectively. Indeed, providing a safe 
therapeutic environment is an essential attribute of and foundation for 
high quality care.
    Despite their prevalence and cost, most healthcare executives, 
clinicians and consumers are largely unaware of the prevalence and cost 
of therapeutic adverse events. Many factors account for this lack of 
awareness, including especially the systematic underreporting of such 
events and the prevailing ``name and blame'' culture founded on the 
myth of perfect performance. This ``name and blame'' culture causes 
fear of punishment, reprisal and/or peer disapproval when an adverse 
event does occur, and it has been particularly counter-productive to 
dealing with the issue in a forthright manner.
    It is widely known that error is inherent to anything that humans 
beings do, and substantial evidence exists that errors are the result 
of poorly designed processes and systems that fail to account for the 
inherent limitations of human performance. Indeed, because medical 
errors typically involve problematic processes or systems rather than 
the incompetence or malice of individual practitioners improvement 
strategies that punish clinicians for reporting errors are misguided.
    In my opinion, ten things, at a minimum, must be addressed if 
medical errors are to be reduced. These include the following:
    1. Get more complete data. Foundational to any improvement effort 
is defining and measuring the extent of the problem. At present, 
medical errors are grossly under-reported, and there is extremely 
limited data about their occurrence. Creating an error data collection 
system is essential to the success of efforts to reduce their 
occurrence. Likewise, sharing information about errors with frontline 
clinicians is needed to further their understanding of the issues, as 
well as to promote collaboration and a sense of shared mission.
    The Institute of Medicine recommended that a national mandatory 
reporting system be established that provides for the collection of 
standardized information about adverse events that result in death or 
serious harm to patients, and that the NQF be tasked with promulgating 
and maintaining a core set of reporting standards. The IOM further 
recommended that Congress pass legislation to extend peer review 
protections to data related to patient safety and quality improvement 
that are collected, analyzed and used solely for the purposes of 
improving safety and quality. I support those recommendations, and I 
would strongly underscore the need for having a non-punitive approach 
to gaining this data.
    In considering the data, it is important to remember that reporting 
such events is for both public accountability and quality improvement 
purposes, and not everything reported for quality improvement purposes 
warrants public reporting. There is a set of adverse events or untoward 
situations about which we could obtain widespread consensus on the need 
for reporting for public accountability (e.g., maternal death during 
childbirth, restraint-related strangulation, wrong-site surgery, to 
name a few), but there is a larger pool of events or circumstances 
that, at least at this time, should be maintained confidential for 
quality improvement purposes.
    2. Make patient safety a priority. Government health programs, 
healthcare organizations and healthcare executives should make reducing 
medical errors and improving patient safety key strategic priorities. 
This should occur at all levels of government and at all levels of 
healthcare organizations or institutions.
    Patient safety work should be built into the schedule of managers 
and should be a defined executive responsibility. Patient safety issues 
should receive as much attention by healthcare facility governing 
boards as do issues like financial performance, market share and 
strategic planning. Healthcare facility management should be held 
accountable for patient safety performance just as they are held 
accountable for other performance.
    3. Create a patient safety infrastructure. If medical error data 
are to be collected and if patient safety is to be a priority, then it 
must have a home within healthcare facilities, healthcare organizations 
and relevant government agencies, and there must be individuals that 
are responsible for managing the data and associated programs. The NQF 
supports the notion of their being a national Center for Patient 
Safety, although we defer to the Congress and the Administration as to 
where such a center should be housed. Wherever it is located, though, 
it must be provided with adequate resources to accomplish its mission.
    4. Create a culture of safety. Healthcare executives and managers 
should strive to create a culture of safety in their institutions or 
organizations.
    A healthcare culture of safety can be defined as an integrated 
pattern of individual and organizational behavior, and the associated 
underlying philosophy and values, that continuously seeks to minimize 
hazards and harm to patients that may result from diagnosis and/or 
treatment-related processes. A culture of safety identifies safety as a 
priority and aligns organizational objectives and rewards accordingly.
    A number of characteristics define a healthcare culture of safety. 
For example, in a culture of safety there is open acknowledgement that 
modern healthcare is a high risk activity and that everyone in 
healthcare has a responsibility for risk reduction and error 
prevention. Errors are recognized and valued as opportunities for 
improvement, and there is a non-punitive and safe environment in which 
errors can be learned from. There is honest and open communication 
about safety issues with well known mechanisms for reporting and 
learning from errors, and confidentiality of information. Likewise, in 
a culture of safety there are mechanisms for restitution and 
compensation for injuries that result from errors, and clear 
organizational commitment, structure and accountability for safety 
improvement.
    5. Implement patient safety best practices. Healthcare leaders and 
organizations should implement medical error ``best practices'' when 
such have been identified--e.g., such as those identified by the 
Massachusetts Hospital Association, National Patient Safety Partnership 
and Institute for Safe Medication Practices. This is especially so for 
medication safety practices, where a number of practices have been 
shown to definitely reduce errors.
    6. Professional misconduct must be recognized and dealt with. Gross 
negligence, malfeasance or unethical behavior should be recognized as a 
grave threat to patient safety and should be dealt with accordingly. 
Licensure, credentialing and privileging bodies should more 
aggressively discipline practitioners who have demonstrated impaired 
performance of this nature.
    7. Healthcare regulators and accreditation organizations should 
embrace measures that enhance patient safety. Regulations and 
guidelines should encourage root cause analysis and facilitate non-
punitive reporting. Similarly, pharmaceutical and medical device 
manufacturers should be required to complete and disclose human factors 
testing of naming, packaging and labeling of medications and post-
market surveillance of adverse events.
    8. Patient safety self-assessments should be conducted. All 
healthcare facilities should routinely conduct self-assessments for 
risk reduction and error prevention. When available, structured and 
standardized self-assessment instruments should be utilized--e.g., the 
self-assessment instrument developed by the Institute for Safe 
Medication Practices for medication safety practices.
    9. Patient safety research should be funded and otherwise 
supported. While a number of interventions are available that could 
improve patient safety in the short term, there is a great need for 
additional research in the area of medical error reduction and patient 
safety. Research is needed in ways to make care processes safer, in how 
to make reporting systems optimally useful, and in ways of 
communicating information about healthcare hazards that do not unduly 
alarm patients, to name some fertile areas of research. Likewise, while 
basic research is needed in many areas, there is also a great need to 
investigate technology transfer and the application of safety lessons 
from other industries to healthcare. A good model for the latter are 
the Veteran Health Administration's Patient Safety Centers of Inquiry.
    10. Medical education should address patient safety. Patient safety 
needs to be incorporated into the fabric of health professional 
training at all levels. Indeed, a significant part of the problem 
regarding the failure of physicians to report medical errors stems from 
attitudes and beliefs instilled during medical school. The fact that 
everyone makes mistakes, regardless of how well trained or how smart 
one is, and that modern healthcare is an inherently high risk, high 
hazard activity should be promoted throughout one's training, along 
with how mistakes should be managed.
    Professional organizations and credentialing bodies should also 
give consideration to requiring continuing education specifically in 
patient safety, such as is required of practitioners in the veterans 
healthcare system.
                               conclusion
    Clearly, reducing medical errors and improving patient safety in 
U.S. healthcare present many challenges, including the very real fears 
that so many caregivers have of reporting therapeutic adverse events, 
the fear of liability and tort claims, the lack of systems thinking and 
the poor understanding of so many medical ``treatment systems'' and 
uncertain support for a non-punitive approach to dealing with errors. 
Despite these challenges, however, improvement in patient safety is 
eminently achievable, as has been demonstrated in the veterans 
healthcare system.
    In closing, Mr. Chairman, I would note that too often Americans 
equate high technology healthcare with high quality healthcare. In some 
cases, this nexus is true, but in many other situations more 
sophisticated technology simply creates a delusion of higher quality, 
while increasing the risk of medical error. As healthcare becomes more 
and more reliant on complicated technology there will be increasing 
need for vigilance against errors. Many actions need to be taken to 
ensure that such vigilance is actualized and that healthcare in the 
21st century becomes safer than it is today. The ten actions described 
above would be a good beginning in this regard.
    Again, thank you for the opportunity to testify before you this 
morning. I would be pleased to answer your questions.

    Mr. Bilirakis. Thank you very much, Doctor. Mr. Bovbjerg.

                STATEMENT OF RANDALL R. BOVBJERG

    Mr. Bovbjerg. Thank you very much, Mr. Chairman. It is a 
pleasure to be here. My basic position on medical error and 
medical injury is probably the same as everyone else in the 
room. I am against it. The real thing that divides people is 
what they think will work. I think this is really quite a non-
partisan issue. It is a pragmatic issue. But there are two 
competing world views here. There is the general----
    Mr. Bilirakis. Speak directly into the mike, if you would, 
please, sir.
    Mr. Bovbjerg. There is the inherited from the past system 
of name and blame and disclosure that we have heard about and 
there is the new motivation of taking more of a systems or 
corporate approach and at least trying to create a culture of 
safety without blame within it. There is a tension here and the 
IOM report deserves tremendous credit for raising the 
visibility of this issue for finally making it less deniable 
that there are problems out there and for at least starting to 
sketch what we could do about it.
    The sketch remains somewhat conceptual, however, and there 
is an awful lot of work yet to be done. I want to cover three 
areas. I did cover three areas in my written statement. Let me 
hit on real quickly now. First of all, information is one 
strategy. Clearly, feedback of information is crucial. The 
voluntary and mandatory reporting that the committee 
recommended are a core method for dealing with these things. I 
happen to think that a real problem here is the reporting of 
the information and encouraging people to give the information 
reliably and timely. I think the voluntary systems are almost 
certainly an improvement over what there is now.
    I think the mandatory one builds upon what there is now but 
doesn't copy it exactly. I personally would not go for the full 
and open disclosure of the mandatory reporting that has been 
described. The mandatory ones that are out there now generally 
have confidentiality and even so they get terrific under 
reporting as described in the statement. Beyond the information 
issue is the motivation issue. There is a lot that can be done. 
One can hire Dr. Kizer, Dr. Berwick to come in and help one get 
going but there is a major issue at motivating people to do 
this. It is not happening.
    There is still a lot of complacency. There has been 
progress made but it is not done. That is one reason for the 
support for the disclosure and the disciplinary action and the 
lawsuits is this motivation. The difficulty with that is that 
we have had that for a long time and we are where we are. We 
have that type of system. It has done what it can do and that 
leaves us with the problems that we have. The real difficulty 
in terms of the information piece is that this type of 
oversight tends to drive information underground.
    I would recommend that people think a lot harder, and IOM 
has started this but only just started, think a lot harder 
about what else we can do, and that is beginning too. Quality 
measures that are broader and more objective that sweep in 
information about errors within them, real demands by 
purchasers that systems be created to deal with this, and on a 
confidential basis reviewing that and keeping people's feet to 
the fire. I think that generalized type of approach is apt to 
be very important. We can't let the complacency continue. I 
think if what you do with the fire is instead to create a 
branding iron and want to brand everyone with a big red letter 
E and put them on the Internet, they are not going to cooperate 
with you quite as readily. So I think it is quite important 
exactly what is going to be done with these data.
    Then finally is the issue of implementation or management. 
You can have all the good intentions in the world. You do have 
to have--you take a systems approach but you have to have a 
system. Someone has to be doing this. And there is quite a bit 
of difference between the VA model and it is certainly a 
pleasure to a policy analysis like me to see a government 
agency in the forefront and actually leading the private sector 
in many ways but there is a big difference between that model 
of an integrated system and the private sector model of a much 
more decentralized system.
    The hospital is a place to start but even hospitals differ. 
And of course as has been mentioned, we have got a long way to 
go before we get to outpatient. So we are well on the way. I 
think we need to get started. We need to keep up the pressure. 
Let us not move immediately to full disclosure and put all our 
eggs in that basket. Let us make sure we get the information 
out and move slowly in these ways. Thank you.
    [The prepared statement of Randall R. Bovbjerg follows:]
   Prepared Statement of Randall R. Bovbjerg,\1\ Principal Research 
                     Associate, The Urban Institute
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    \1\ This statement represents the view of the author and not that 
of the Urban Institute, its sponsors or trustees.
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    Thank you for inviting me to testify today on ``Medical Errors: 
Improving Quality Care of Care and Consumer Information.'' My testimony 
addresses voluntary and mandatory reporting of information about errors 
and associated confidentiality issues.
    The Emergence of Patient Safety. Researchers on injury and 
liability issues have long recognized that medical injury and medical 
error occur too often. If they were a disease, they would have their 
own Institute at NIH. Moreover, injuries far exceed traditional efforts 
to fix them--medical peer review, regulatory discipline, or legal 
liability and risk management. Fortunately, many injuries not prevented 
by current oversight systems nonetheless seem preventable.
    Better prevention requires a new mix of information, motivation, 
and implementation. The big question now is what mix of policy tools 
can best address prevention in various medical settings, for various 
types of care and their characteristic problems. Observers and policy 
makers differ in their conceptualization of problems and in the 
emphasis they would put on different policy tools. I urge you today to 
consider that a multiplicity of tools may be appropriate, each in their 
own way, but that we proceed carefully and avoid working at cross 
purposes.
    This hearing continues the lively debates sparked last November by 
the Institute of Medicine (IOM) report To Err Is Human. This book has 
performed an extremely valuable service. More successfully than any of 
the prior efforts on which it builds, the IOM panel has highlighted 
existing knowledge on the extent of preventable injury, mainly in 
hospital care. This alone has put patient safety higher on the policy 
agenda than ever before. This is an extremely exciting and important 
development.
    Better yet, the book describes emerging methods of preventing 
medical errors from hurting patients and lays out a vision of patient 
safety as an alternative approach to error. The book focuses more on 
systems design and operation than on individuals. It emphasizes the 
manifold nature of errors and how prevention calls for developing and 
implementing a variety of techniques to identify problems and achieve 
solutions. It also seeks to de-emphasize retrospective blame finding as 
a policy tool in favor of front-end safety design, catching errors 
before they can reach patients, and building in self-monitoring and 
continuous improvement for the future.
    In short, the IOM panel presents a very attractive vision of 
patient safety as a general approach, with specific examples from a few 
clinical areas. Actually getting clinicians and clinical managers to 
act in this fashion is a tall order. There are many real-world examples 
of significant progress, but there is a long way to go. Another tall 
order is balancing the social demand for external accountability with 
the prescription to downplay blaming. In short, more is known about 
problems than about what approaches to improvement works best. But 
that's normal. The ability to diagnose problems always runs ahead of 
the ability to prescribe cures.
    Speaking personally, my own research for twenty years addressed 
malpractice mainly as a matter of law and liability insurance. I wrote 
about how those systems perform, and how actual and proposed reforms 
affect that functioning. A particular interest has been no-fault 
alternatives, which have the potential for efficiencies as well as for 
sending clearer signals to practitioners about the extent and nature of 
medical injuries. It has long troubled me that medical-legal research 
has always found significant levels of preventable injury--starting 
with the first systematic study of medical injury and negligence in the 
early 1970s.
    My own first project specifically on injury prevention began just 
two years ago. Since then, I've learned much more about the practical 
issues of making changes in clinical and administrative systems to 
protect patients. One very recent advance is that ``patient safety'' is 
now readily understood to mean protecting patients from medical injury 
in many ways. Only two years ago, even well informed clinicians and 
risk managers usually thought of ``safety'' as having to do with 
hazard-free premises--well lighted parking lots, non-slippery 
stairwells, clearly marked fire exits, and the like. ``Risk 
management'' usually meant defending against lawsuits and coping with 
other legal system demands on clinicians, like Medicare compliance 
issues. There was little attempt to actively address any factor that 
might hurt patients.
    All this seems to be changing as some medical leaders are learning 
more about promoting safety, not just avoiding malpractice. Efforts are 
underway in many institutions across the country, not just hospitals 
but also large physician groups. This type of work is much more 
exciting in terms of direct improvements for patients than lots of 
debates I've been in about law and insurance or the pros and cons of 
tort reform.
    Learning from Reporting Systems across Institutions. This morning, 
the main topic is the potential role for medical error reporting. 
Sharing information across sites through reporting can help build the 
knowledge base for improvement. One must start with information about 
how different types of medical errors occur and how they reach patients 
in order to begin to prevent them. Medical providers have important 
information--what clinicians knew and did or didn't do, the 
circumstances of a case, the environment in which it occurred. One key 
to improvement is to be able to study occurrences, errors that led to 
injury or might have done so. Much can be learned by self study and 
literature review, especially in hospitals or large physician groups. 
Sometimes, however, larger scale is needed. Hence the interest in 
reporting systems to compile information on error in medicine.
    Institutional care is the focus of most existing reporting systems 
and the IOM proposal--especially hospital care. It's plausible that the 
need for more information is even greater for non-institutional care, 
where individual and small groups of practitioners lack the advantages 
of scale and scope of larger entities. Outpatient care is generally 
believed to have less potential to hurt patients than more complex 
hospital care for sicker patients. Still, ``failure to diagnose'' 
liability cases are among the more expensive claims, and there are also 
many issues of follow up and coordination of care among independent 
offices. Outpatient care, however, remains a raw frontier for safety 
development.
    For the IOM panel, I and my colleague David Shapiro, an M.D., J.D. 
expert from California, examined some aspects of reporting systems. We 
researched a number of leading voluntary systems, concerns about their 
ability to maintain confidentiality, and what existing and potential 
legal protections could enhance confidentiality. We inevitably also 
learned about some mandatory programs, though with less detail. Our 
conclusions are fairly presented in chapter six of the IOM book (pp.94-
113): Liability law gives broad scope to litigants to discover 
information relevant to their claims, or even that might lead to 
relevant information. When quality-oriented information is kept 
confidential within a health care entity (mainly hospitals) and used 
for peer review purposes, it is typically not discoverable. Risk-
management information for defense of claims also has some protection 
from discovery.
    These protections are seldom absolute, however, and sharing data on 
problems outside the entity raises legal vulnerabilities. Information 
need not be definitive to be useful. One attorney noted that it is 
helpful just to know that a patient's hospital chart was submitted to 
the peer review committee, despite the absence of information about the 
confidential review or its findings. Just seeing the stamp ``referred 
to peer review'' on the chart used to make it much easier to get an 
expert witness to review the case. Hospitals learned of this effect and 
stopped using such stamps.
    This illustrates a key observation about data on errors. People are 
very reluctant to report on themselves or colleagues unless they have a 
reasonable expectation of confidentiality. Whatever one's views about 
the appropriateness of open confession of error, it is a practical 
reality that few medical practitioners want to do it within what they 
perceive as a litigious or vengeful environment. All our interviewees 
at reporting systems stressed the importance of confidentiality in 
getting practitioners to report; fears of legal and other repercussions 
are very strong. All said they thought reporting of errors falls vastly 
short of the true extent of error.
    It is difficult to get people to discuss potential failures at all, 
much less report them to regulators empowered to discipline them, 
especially if litigators may also get hold of them. Hesitation is built 
into behavior even without disclosure. Note, for example, that the 
first information a liability insurer or hospital risk manager often 
gets that something may have gone badly wrong in patient care is an 
inquiry or notice of suit from a patient's attorney. Reporting by the 
practitioners involved has traditionally been very low--even though 
they are contractually obligated to report claims, even though they're 
reporting only to the people whose job it is to defend them, and even 
though the reports are internal and confidential.
    Stronger confidentiality protections would probably improve 
voluntary data sharing. That's why the IOM panel recommended new 
federal legislation. If cross-state reporting is to expand greatly, 
this may indeed be required. There are existing legislative models of 
confidentiality protection on which to base new rules, including those 
applying to peer review and to the National Practitioner Data Bank. The 
panel recommended a decentralized approach, as different expertises and 
scales of operation are appropriate for different types of problems--
drug errors, blood transfusions, emergency medicine, and so on.
    Many states have created mandates for hospitals to report serious 
injuries to a state regulatory agency, often along with other matters, 
including epidemics and fires. Typically, a case is confidential unless 
the agency takes formal action against the institution. Legal 
requirements and conditional confidentiality may plausibly increase 
reporting overall, though this is undocumented. But it seems clear that 
even a long-standing mandate, as in New York or California, elicits 
only a few thousand reports of unnatural deaths or serious injuries a 
year (see Appendix D of the IOM book, pp. 210-217). The rate of error 
and serious injury found by hospital chart review in those states is 
far higher. Mandatory reporting may or may not find more problems than 
does the liability or peer review system.
    For purposes of learning from reported mistakes, incomplete 
reporting may not be critical. A clinical or administrative manager at 
hospital X can see that others also have a lot of problem Y and hence 
decide to take action. An area for much greater work is how to report 
or otherwise generalize knowledge about solutions as well as problems.
    Reporting systems cannot measure the true incidence of particular 
problems, however, because they don't know either of the two key 
factors: They cannot count how many errors truly occurred (say, in a 
state or in a type of hospital). Nor do they know how many patient 
encounters it took to generate the observed level of reported cases. 
For this reason, it's a bit troubling that incomplete systems can be 
used to discipline medical providers.
    Reporting Systems as Motivators of Change. This observation leads 
to a second issue about safety--how to motivate change among doctors 
and hospitals. Here, the IOM panel touched briefly on the importance of 
corporate leadership (chapter eight, pp. 143-144) and appeals to 
professionals' desire to excel in quality, now including attention to 
error prevention. These are good things. However, considerable outside 
pressure seems needed as well. It's taken a long time, after all, for 
most medical leaders to begin to accept that major improvements seem 
possible, despite all the rhetoric about American medicine as the best 
in the world. And complacency about performance continues; many 
hospital executives seem to think they are doing enough about injuries 
already.
    Enter state regulators as motivators. The threat of sanction after 
investigation of a reported serious occurrence is surely meant to 
encourage change. How well this works goes beyond the scope of the IOM 
book and is worthy of much more attention. How well staffed and funded 
are the relevant agencies? What are their capabilities to investigate, 
especially promptly and outside their home offices? How much are 
individual cases studied as against patterns of problems? Can 
regulators recognize when other factors than error affect reporting 
(e.g., nurses' labor dispute with hospital)? What sanctions do 
regulators use? How much acceptance is there of the appropriateness of 
their findings among the regulated entities? Do the regulatees in fact 
change? How do regulators try to generalize advice to the industry at 
large? The questions go on and on.
    Given the wide range of unanswered questions, the appropriate 
federal action at this point seems to be to learn more about what 
states are doing and accomplishing rather than to mandate federal 
minimum standards. According to news reports, the Administration has 
decided to oppose mandatory, open reporting at this stage. I agree with 
that position.
    Proponents of traditional and expanded litigation normally assert 
that motivating preventive efforts is their key contribution--what 
lawyers call deterrence. This must be at least partly true: The highly 
successful anesthesiology guidelines, even the patient safety movement 
itself, was partly a reaction to liability pressures. Formal research 
has found little evidence of deterrence, however. Support for the 
hypothesis that exposure to fault liability promotes safety comes from 
some studies comparing no-fault with fault-based systems for auto 
accidents. Yet the tie between lawsuits and motivation to promote 
safety seems weak. Hospitals and other entities within a particular 
jurisdiction all face the same basic legal rules, yet they differ 
greatly in their willingness to tackle patient safety as a management 
priority. Moreover, to repeat: whatever the level of deterrence has 
been accomplished by liability pressures, it hasn't done enough to 
protect patients. And it tends to inhibit open sharing of data and 
methods for safety, even internally.
    One last comment here: Regulation and litigation are not the only 
tools available to motivate change. It's appropriate for buyers of 
health care to demand much more of providers. That is another major 
topic on its own. It seems possible to start with some outcomes 
measures, such as rate of late discovery of cancer, and more pressure 
for providers to adopt processes thought to help reduce errors. Again, 
to the extent feasible, at this stage of development it seems 
preferable to emphasize support for improved processes rather penalties 
for poor outcomes. Hospital accreditation is doing some of that 
already, but buyer pressure offers another useful approach, one barely 
touched upon in the policy debate thus far.
    Implementing Change. Changing clinical and administrative processes 
to protect patients calls for good management, beyond good information 
and motivation to act. It is one thing for leaders or outside experts 
to proclaim devotion to patient safety and discuss methods in general 
terms, quite another to make changes in everyday practice. It is 
notoriously difficult to manage health care providers, and the 
appropriate system to manage is not clear, especially outside of 
hospital-based and large physician group practice. Very few private 
entities have anything like the corporate organization of Veterans 
Affairs, where top leadership has begun substantial change. Management 
issues merit much more attention.
    Readers will note that this testimony has become sketchier as it 
proceeds from theory to actual implementation of change. There is a 
reason for that. Theory is running ahead of practice. Much remains to 
be learned, but the promise is bright.

    Mr. Bilirakis. Thank you very much, sir. Dr. Berwick, I was 
pleased that you made your last two comments, that I had to 
sort of rush you through, principally because I picked those up 
in your written statement and had planned to go into them with 
you. And, in fairness, I again repeat that you said that they 
represent your personal viewpoints and go beyond the findings 
of the IOM committee. First, you state that you consider the VA 
a model for us all and that certainly is a compliment to Dr. 
Kizer and others in that it has a mandatory requirement that 
serious injuries and errors be reported to patients and their 
families.
    And of course the point made by Mr. Bovbjerg I think is a 
very significant point in terms of the distinctions between 
work of the VA and the private sector. But then you also state 
or perhaps maybe imply that some form of tort reform is 
necessary. You write that you believe strongly that movement 
toward a no fault, and you said that again orally, malpractice 
litigation system would help increase safety-oriented activity 
immediately. Well, I think those are two very significant 
statements and I wanted you to use most of my time to possibly 
elaborate on those.
    Mr. Berwick. Thank you, Mr. Chairman, and for reminding us 
that these are my personal comments. On the issue of mandatory 
reporting, I think we are confusing two very important issues. 
One is the public reporting to some authority of sentinel 
events for the purpose of public accountability but I think 
meshed in with that is this additional issue if a patient is 
harmed by care that is intended to help them, do they have a 
right to know about that.
    I think the professions and the organizations would say yes 
but I am not personally assured that we are doing this, and I 
would like some kind of assurance and think the public deserve 
it that if one is injured by care, one is told that. The VA is 
leading the way in that and is able to show that such a system 
can work. The second issue of tort reform is a much more 
difficult one. If we truly believe that most of the harm is 
done to patients by their care occur from systems then the 
accountability is a system level accountability.
    A tort reform system addressed to individual miscreants 
misses the point. It is not fixing the accountability where it 
belongs that leads me to prefer a kind of enterprise liability 
to an individual. More than that, the malpractice environment 
is use by this industry as an excuse for not studying in depth 
and sharing information about its errors and so as long as that 
excuse is there, I fear we will lack the momentum that we could 
establish. If we had tort reform it would take the excuse away 
and we would have daylight on the problem more easily.
    I am cautious about that because as I say there are some 
organizations that have been able to establish robust voluntary 
reporting systems through courageous executive leadership 
without a change in the malpractice climate but I don't think 
heroic behaviors of that kind are going to be very common.
    Mr. Bilirakis. Well, you know, Doctor, many years ago 
during my earlier years in the Congress, I had prepared a 
proposal that would be a no fault system similar to workmen's 
compensation. The Workmen's Compensation Program was probably 
rocky initially but it is working. And that is, I guess, what 
you are proposing and I commend you for that.
    Mr. Bovbjerg. Mr. Chairman, I could also submit more on 
that from earlier work----
    Mr. Bilirakis. Sure, please do.
    Mr. Bovbjerg [continuing]. To deal with a no fault system. 
I will give you an article from the Journal of the American 
Medical Association proposing such a system for obstetrics to 
replace the current one.
    Mr. Bilirakis. I would like to see that very much. Thank 
you. Thank you, Mr. Bovbjerg. In the IOM report, at least to my 
knowledge, you did not compare what is happening in this 
country versus other industrialized nations, England, Canada, 
etc., etc. Any comments from any of the three of you regarding 
that?
    Mr. Berwick. We have had several studies--we are aware of 
several studies in the UK, Scandinavia, and most importantly 
Australia replicating the same methodology that was used in 
Colorado and Utah and in New York, which used identical 
methods. The Australian study showed rates of injury in the 
Australian medical care system of little more than double those 
in the U.S. system which has caused great concern in that 
country. We have very early findings in the UK showing similar 
error rates.
    Mr. Bilirakis. Double?
    Mr. Berwick. No, similar to the U.S.
    Mr. Bilirakis. Similar to the U.S. Anything further, Dr. 
Kizer, Mr. Bovbjerg?
    Mr. Kizer. I was just going to make the point that there is 
very little known from elsewhere in the world with the 
exception of the countries that were mentioned and in those 
countries they certainly can't be looked to as ways of doing it 
better perhaps, that their data suggests that the problem is 
comparable or worse than what we have.
    Mr. Bilirakis. My time is up. Mr. Green, to inquire.
    Mr. Green. Thank you, Mr. Chairman. Dr. Kizer, we are 
hearing a lot about the need to create a non-punitive recording 
system to gather data on medical errors so we can learn from 
our mistakes but the discussion has focused on confidentiality 
protections for the information. However, protecting the 
reported information won't necessarily address other reasons 
people don't report, not necessarily the fear of lawsuits but 
the fear of embarrassment because of one's fear that their 
supervisor will find out, fear of losing their job or losing a 
possibility of promotion. Would you agree it is important to 
offer individuals protection from retaliation as well as for 
the agency?
    Mr. Kizer. I think that has to occur. Now whether it occurs 
by statute or by personnel policies and the culture that is 
created, I think that may be the question that you are asking. 
I know part of what was tried to be effected in the VA was to 
create a culture and to have personnel policies that were 
supportive of reporting errors of openly discussing the 
information and that did not necessarily require any statutory 
or regulatory changes.
    Mr. Green. So the protection was not just to the agency, 
the VA, the local hospital, but also to the individual staff 
members?
    Mr. Kizer. That is correct although I would in saying that 
underscore the point that while there may be a very small 
minority of individuals who do grossly negligent or unethical 
things that whatever protections are accorded to individuals 
that those protections should not be an excuse or a way for 
unethical behavior or malfeasance to be condoned.
    Mr. Green. Well, again, that should apply to the 
institutions as well as to the individual.
    Mr. Kizer. Yes. I think the differences at one level, those 
policies or protections would be accorded. There is much that 
can be done within institutions just by policy of the 
institution to get where we need to go without any changes in 
laws or regulations.
    Mr. Green. I notice one provision in the Patients' Bill of 
Rights that recently passed the House would provide protections 
for healthcare workers who report quality problems or errors to 
the appropriate body, and I believe this is an important 
protection for the individuals to improve that quality of care 
and reduce the errors. And, again, to follow up on the 
chairman's concern, and that was my question about whether the 
international numbers, whether it is Australia or another 
industrialized country, are comparable to what was shown in the 
IOM study. Thank you, Mr. Chairman.
    Mr. Bilirakis. I thank the gentleman. Mr. Stearns to 
inquire.
    Mr. Stearns. Thank you, Mr. Chairman. Dr. Kizer, as you and 
I both know, we had hearings on this and you testified and when 
we talked to you, you went back and set up sort of a National 
Safety Center, to use your term, something in Veterans' Affairs 
to make sure that all this was reported. But as I recollect, a 
lot of the hospitals didn't participate. They wouldn't do it on 
a regular basis and you didn't feel the information was 
forthwith in coming. So I guess my question is, is there enough 
on the veterans' side for us to extrapolate to the private 
sector and what could have been more successful on the 
veterans' side to make it work better?
    Mr. Kizer. How many hours do we have? Very quickly, I think 
that there is experience from the VA that is transferable and 
there is much that can be learned there but I would echo what 
Mr. Bovbjerg said that the VA as an integrated system is 
different than much of what occurs out in healthcare. As one 
example, medication errors, the VA made a policy to implement 
some technology that cost some dollars, millions of dollars, 
across the system to reduce medication errors. Because of the 
way the VA is financed and the way the funds are distributed 
that was--the system realized the return on investment.
    If you took that same analogy to the private sector today 
hospitals that have to would invest in that. The return on 
investment would go back to the health plans and the hospitals 
would be unlikely to see any of the return on investment. There 
are numerous examples like that where if you look at the 
fractionated non-system that we have in the private sector as 
opposed to a fully integrated system such as the VA, while 
there are lessons there, there are differences that have to be 
recognized as well.
    I think going back to the other point that you made about 
the difference in reporting, I think we have to recognize that 
this is a long-term effort that requires changing the entire 
culture. You and I had discussion both in the hearings as well 
as off line that I think I made the point to you, a couple of 
points, that, one, the VA was not--the rates were not much 
different than I saw in the private sector as a former 
regulator of hospitals, and, second, that this was something 
that if we did it right and the reporting that the numbers 
would go up dramatically.
    And indeed that is what you have seen with the system that 
has been put in place in the VA. But even so, if you may recall 
the medical inspector's report the highest--the two networks 
with the highest and the lower rate of reporting and a 
difference by a factor of 10, both were in the State of New 
York, a State that happens to have two networks dividing them. 
So even though in the same system with all the same 
encouragements and the same assertations, you can see within a 
relatively small geographic area marked differences in 
reporting largely to do with again the culture that exists in 
those areas as opposed to the rules or what not of the system.
    Mr. Stearns. Dr. Berwick, we in our Veterans' Affairs 
committee, we had a Ph.D. come to our hearing and said you are 
safer in an airplane than you are in a hospital and Mr. 
Gutierrez made his comment at that point. What do you think of 
what Dr. Kizer mentions in terms of a National Safety Center, 
and perhaps in line with this to get this cultural change is to 
make it a no fault. You would not deny the ability of the 
patient to sue, his constitutional right, but you would have a 
no fault accountability so that all of this would come in and 
it could be used on a system basis to determine what we could 
do not only to change the culture but the procedures.
    Mr. Berwick. Aviation is an industry that has a culture of 
safety and had made tremendous progress in improving safety for 
passengers. I think the aviation is at least ten fold safer now 
than it was 20 or 30 years ago for passenger miles despite the 
fact it is a much more complex industry today. It committed to 
safety. They have achieved it larger through science. The 
aviation industry understands how systems work and what system 
properties are safer than others. They understand how to make 
communication fail safe. They understand how to make equipment 
reliable. They understand the----
    Mr. Stearns. So you support a National Safety Center that 
Dr. Kizer mentions?
    Mr. Berwick. Absolutely, yes. If we can apply that same 
science in healthcare the progress would be immense.
    Mr. Stearns. Mr. Bovbjerg, what is your comment about a 
National Safety Center?
    Mr. Bovbjerg. Oh, it makes terrific sense to me. Again, I 
would emphasize here we have an industry in the airlines in 
whose interest it is to make changes and which will directly 
benefit from that. It is a little less clear in healthcare. The 
pilots, stewardesses, mechanics, and so on, who report in the 
aviation industry directly benefit in a way that the doctors 
and nurses and so on don't. The discoverability of plane 
crashes is very high. The discoverability of errors is not in 
medicine. So I think there are differences but surely one can 
learn by looking at this.
    I think Don and many others have done that, are learning. 
The issue is how do you get people to surface this stuff so 
that you can begin to learn and change. And now it is difficult 
and it is difficult even internally when a hospital or a staff 
model HMO or a large physician group tells the doctors and 
nurses let us know early about problems so we can intervene so 
we can do something.
    They beg and very often this doesn't happen and the first 
time that a risk manager in a hospital or a physician group 
hears about a problem is when the plaintiff's lawyer calls. 
That is not good and that is with confidentiality and so on. 
There is a lot of work to approve reporting and to generate 
this information. It is quite sporadic and unreliable now.
    Mr. Bilirakis. Thank you. Thank you, Mr. Bovbjerg. Mr. 
Strickland to inquire.
    Mr. Strickland. Thank you, Mr. Chairman. Mr. Berwick, I 
wanted to focus on your support for a no fault liability system 
and I make reference to the To Err Is Human report and the 
incredibly dramatic reductions in deaths in the area of 
anesthesiology. I would just like to share those statistics. 
Some studies in Australia, the United Kingdom and other 
countries today indicate that anesthesia mortality rates are 
about one death per 200,000 to 300,000 anesthetics administered 
compared with two deaths per 10,000 anesthetics in the early 
1980's, an incredibly dramatic reduction in the loss of human 
life.
    But isn't it true that one of the reasons that anesthesia 
has moved in such an aggressive way to improve the performance 
has been the fact that they have been faced with liability and 
that that is one of the motivating factors in focusing 
attention on the need to bring about these dramatic 
improvements in healthcare?
    Mr. Berwick. Historically I believe you are correct. The 
concern about high malpractice rates was one of the motivating 
factors but I don't think it by any means was the only one. I 
also noticed that the liability for anesthesia deaths is also 
nested in the institution itself so I think that it supports 
the notion that organizational liability is constructive.
    Mr. Strickland. And that leads me to a second question that 
I think is related to the systems or enterprise liability and 
that is where would the source of revenue likely come from, and 
I use for the purposes of contrast workers' compensation system 
is funded by a tax on employers, the vaccine injury program is 
funded by a tax on vaccine, automobile no fault insurance is 
funded via a mandate that drivers carry insurance in order to 
obtain a driver's license and so on. Where would we likely find 
the resources or the money to pay for a no fault system in your 
opinion?
    Mr. Berwick. It is only an opinion. Mr. Bovbjerg has better 
data than I do. Understand now though according to the same 
studies that have yielded information on errors there is a 
tremendous mismatch between the way the tort system works now 
and just compensation to patients. Most suits do not involve 
errors and most errors don't arrive at suit.
    In addition, most of the compensation doesn't ever reach 
the patient so there is a lot of wasted money in that system 
right now. Exactly how the numbers work out, I am not an expert 
at it and I don't know but we don't have a system right now 
that is matching injury to compensation at all.
    Mr. Strickland. Thank you very much. I yield back my time.
    Mr. Bilirakis. I thank the gentleman. Mr. Smith.
    Mr. Smith. Thank you, Mr. Chairman. I want to thank our 
witnesses for their testimony. You know, Mr. Chairman, I chair 
the Subcommittee on International Operations and Human Rights. 
We have had about 100 hearings since I have chaired it, and we 
have a number of contentious issues from embassy security. The 
President just signed our bill in November which provides $900 
million additional per year over 5 years for embassy security. 
I raise this because we deal with a lot of issues on that 
committee or that subcommittee where people make assertions. 
And I usually and members of our panel usually act as devil's 
advocates to try to separate fact from fiction.
    And I think it is extremely important, and a lot of our 
issues deal with health, global health statistics that come 
from the United Nations, from UNDP or UNICEF and others, good 
laudable organizations but you always want to know whether or 
not you are dealing with an absolute or as nearly close to 
reality as humanly possible because statistics do drive policy. 
And in looking, Dr. Berwick, at your study and then reading the 
GAO, it does raise questions about methodology that I really 
think need a thorough explanation as to whether or not we 
really do have a figure that truly represents what is going on 
in America.
    The GAO points out, as I said in my opening statement, that 
the widely cited estimate of 44,000 to 98,000 deaths per year 
are attributable to medical errors that come from extrapolation 
of the results of two studies in the U.S. and they were--one 
was in 1984 and one was in 1992. I was in my second term in 
1984 and probably the information that was used then was dated 
because obviously there is lead time in getting that to a 
usable format.
    Certainly it would seem, and maybe I am wrong on this, and 
that is why I want to get to the bottom of this, that this is 
old data and yet the sweeping statement, and Tom Brokaw is 
doing something tonight on this, he may begin by saying that 
American healthcare is unacceptably unsafe today and also that 
upwards of 98,000 Americans die in hospitals this year as a 
result of errors of their care.
    If that is true, we have an epidemic that absolutely has to 
be solved but I am wondering about the methodology, whether or 
not this data is real. And it seems to me if it is just these 
couple of studies as GAO said there is little known about the 
incidence of adverse events maybe you can tell us if there is 
other information that is fed into this, how recent is it. If 
you could tell us what criteria for labeling as patient death 
as a hospital physician medical error. How do you provide for 
provider error and how did you link it to a death? What States, 
hospitals and providers were scrutinized or is it just these 
couple of studies that then this information was gleaned from.
    And HMO early discharges and all the other problems that we 
are seeing crop up in this decade or at least in the 1990's 
relevant to HMOs. I know because I have gone through two 
catastrophic episodes with my parents who died over the course 
of years from cancer that we fought with the HMO. In one case 
an HMO denied 35 times the payment that we after going through 
the gatekeeper and following, we were always dealing with early 
discharge or this not being provided. That could make it even 
worse than the 100,000, I don't know.
    But it seems to me that before we send up that red flag, 
and again you may have a great answer for this, we have got to 
have a basis of fact, a collection of statistics mutually 
reinforcing that clearly lead to the consequences or least the 
conclusions that have been drawn here. If you could answer 
that, I would appreciate it.
    Mr. Berwick. Thank you, Mr. Smith. I welcome scrutiny of 
the data of course. The Colorado and Utah study and the New 
York study were enormous studies. The New York study was a 
review of 30,000 records and the Colorado study of an entire 
population in those two States so these are not small research 
studies. The methodologies were very precise, definitions 
carefully done, and I think they do give us a pretty good idea 
in those two areas what the rates are.
    I have no reason to believe that the rate varies very 
widely, the rate of injuries varies very widely from those two 
studies. Even if they were off by half, if the number of deaths 
is 20,000 instead of 40,000 and it is as likely to be higher as 
lower, we would still have a serious problem. We have many 
small confirmatory studies of medication errors and their 
consequences done in organizational levels which repeatedly 
find these rates.
    The convergence of the Colorado and Utah studies and New 
York is remarkable, 3.7 percent injuries in New York, 3.2 
percent in Colorado and Utah. They differed in lethality but 
not in the actual occurrence. The data bases were 1984 and 
1992. The studies were actually more recent than that. You are 
absolutely right. We don't have large studies on more recent 
data but the committee is aware of the increasing complexity in 
number of medications available, equipment, technologies and 
procedures which would lead us to estimate that the risks have 
probably gone up, not down since that time with or without the 
managed care pressures.
    Mr. Smith. Can you tell us, I know my time is running out, 
what were the criteria for labeling a patient death as hospital 
physician medical error?
    Mr. Berwick. Well, both studies begin with a definition of 
adverse event. Adverse event means an injury from care that 
prolonged hospitalization by at least a day or caused a week or 
more of disability. That is the formal definition. Then those 
were reviewed by trained and calibrated physician reviewers who 
sorted those into systemic avoidable errors built into the way 
the care was offered or something unpreventable like giving a 
patient who might have a reaction to penicillin the first time 
they ever saw it.
    About 70 percent of the errors were attributable to system 
properties that were in principle avoidable. That is what they 
call preventable. The deaths were then attributed to the 
preventable injuries, the number of those that killed people, 
and that is where you get the 44,000 and 98,000 numbers.
    Mr. Smith. I have more questions but I see my time is up.
    Mr. Stearns [presiding]. The gentleman's time has expired. 
Mr. Rodriguez, 5 minutes.
    Mr. Rodriguez. Thank you, Mr. Chairman. Let me first of all 
indicate that I like the recommendations that were made. One of 
the disagreements that I have is that when you look at any 
problem, you look at both the individual and the responsibility 
that the individual has and the buck has to stop somewhere. And 
I agree with you that we have to look at it systemically and we 
have to also view it in terms of the perspective, in terms of 
the culture and we need to do that.
    But at the same time we also need to look at the individual 
perspective. I like the idea of the national center but I would 
also like it if it was also localized because unless you have a 
local board in that hospital to look at the data. I mean the 
medical profession does that. They look at the bad apples. They 
are the ones that report the bad apples and some of them do a 
good job, some of them don't.
    Other review boards have looked in terms of the police, in 
terms of abuse, and that has worked pretty well, and I think we 
can come up with some ideas in that area. I would also add that 
you are right in terms of the fact that right now I think we 
have a cap of 250,000 on a person's life, at least that is my 
understanding. I don't know if I am correct on that or not, but 
I think that when we look in terms of liability we need to 
personalize it. If it is one of our family members, we need to 
hold those people accountable, whoever they are and we need to 
hold that system accountable too.
    And I think that is important, and I just want to thank you 
for being here and I think we are on the right track in terms 
of trying to identify some of those things. I want to yield, I 
know I have a little time, to Mr. Gene Green from Texas.
    Mr. Stearns. The gentleman yields to Mr. Green.
    Mr. Green. Thank you, Mr. Chairman. Just a follow-up. When 
I asked the question about the Patients' Bill of Rights, I 
didn't actually get on the record. I noticed your head was 
nodding, each of you were nodding yes that you agreed that 
protection for healthcare workers who report quality problems 
or errors. Is that correct? If you could answer verbally so we 
can get it in the record.
    Mr. Bovbjerg. Yes.
    Mr. Kizer. Yes.
    Mr. Berwick. Yes.
    Mr. Green. Okay. And one follow-up question for whatever 
time is left. Dr. Berwick, doctors claim that one of the 
reasons they don't talk openly about errors either to the 
patient or to other medical practitioners is because they are 
afraid of potential lawsuits, and I understand that, yet in 
keeping information about medical mistakes underground doctors 
often violate their own code of ethics. The American Medical 
Association code of ethics quotes concern regarding legal 
liability which might result following truthful disclosure 
should not affect the physician's honesty with a patient so 
concern over the liability shouldn't be a legitimate reason to 
keep information about mistakes from patients. Would you agree, 
I mean in an ideal world?
    Mr. Berwick. Absolutely, yes.
    Mr. Green. And I understand that but I also understand that 
often times it is difficult for anyone to admit their own 
mistakes but the medical ethics do require that.
    Mr. Berwick. Yes, they do.
    Mr. Green. Okay. Thank you, Mr. Chairman.
    Mr. Rodriguez. One other comment. I was also concerned that 
not enough recommendations were made in terms of whether it is 
lack of resources that are needed out there, additional 
training that might be needed, and whether we have an 
obligation in terms of what we need to do because I know a lot 
of people are overworked or burned out and a lot of other 
things that are out there. And maybe not enough of that was 
reported in terms of at least from my perspective because I 
know people are out there working real hard and getting burned 
out.
    Mr. Bilirakis. Would the gentleman yield for a moment?
    Mr. Rodriguez. Yes.
    Mr. Bilirakis. Dr. Ganske got into this but his time was 
up. I thought he might be back to possibly get into it again. 
While we need to examine no fault reporting, we also need to 
look at the root cause and I guess that is what Mr. Rodriguez 
is referring to. And I don't know that the IOM report spent 
enough time on that. And I know we have other panels coming up 
and we can go into this with the VA, etc. At the same time the 
root cause has got to be addressed too, not just the reporting 
of it, the liability areas, etc. Thank you.
    Mr. Rodriguez. Reclaiming my time if I have any left, let 
me just indicate that in those situations we know that the root 
cause is not just one, it is a combination of things and we 
recognize that. And from one institution to another, from one 
hospital to another, it will vary, and so I think we need to 
probably move as quickly as possible with some of these things 
and please let us know if we need some additional resources to 
make that happen.
    Mr. Stearns. I thank the gentleman. Did you wish to answer 
that, Dr. Berwick?
    Mr. Berwick. Thank you, Mr. Chairman. This is a very 
important point. There is a nexus of root causes which are 
latent in the system. The reason we want a voluntary system is 
to surface errors before they hurt people and it is very 
important to know that we need a culture which doesn't wait for 
the harm but which says this could have harmed someone. And 
that is where you get most of the benefit in a reporting 
system. You are absolutely right. We need people to be safe to 
talk about latent errors.
    Mr. Stearns. The gentleman from California, Mr. Cox.
    Mr. Cox. Thank you, Mr. Chairman. Dr. Berwick, you 
mentioned in your testimony that if we fired every healthcare 
worker who is involved in error incident, we would not change 
our error rate. And I think the message from the entire panel 
is that what we are trying to do is encourage voluntary 
disclosure, something that doesn't happen right now. Getting to 
my colleague's question from New Jersey, Mr. Smith, until we 
change these things we are not even going to be particularly 
confident in the data that we are collecting because we know we 
can do a much better job of collecting it and certainly 
thereafter of analyzing it if we could encourage more voluntary 
compliance.
    Everyone has directly or indirectly acknowledged that the 
existing legal incentives all run the wrong way at least as far 
as individuals are concerned. If an individual is going to be 
penalized and not rewarded for participating in this kind of 
voluntary disclosure then rather obviously we are not going to 
get it. Do we need to pursue your airline analogy a bit, Geneva 
Convention for healthcare?
    Mr. Bovbjerg. In a sense and in one way the medicine 
panel's recommendation to focus on deaths and very serious 
injuries, at least death cases tend not to be quite so 
expensive as the others when they do surface. They are more 
likely to be found now and so that is a little less threatening 
than throwing open the whole flood gates to everything. But, 
yes, I think in the long run if you want to build a total 
culture you are going to have to address the legal system and 
the disciplinary system which are part of the reason that 
people are reluctant to talk about errors.
    But people are reluctant to talk about errors under any 
circumstance. You have to make it easy for them. You have to 
sell it on them and people like Tom and Ken, they are very good 
at this, that it is in their interest and they can help their 
patients. You sell the prevention. You sell the good. You don't 
sell where you can avoid being dragged into malpractice.
    Mr. Cox. Anybody wish to further comment on that? We are of 
course operating in an industry where insurance plays a 
significant role. Why is it that the external pressure placed 
on the industry from insurers whose interest it is of course to 
minimize the injuries so they don't have to pay for them has 
been inadequate.
    Mr. Bovbjerg. Insurers, of course, generally unlike the VA 
are on year-to-year contracts. The VA has got a lifetime 
relationship with its veterans by and large. An insurance 
company or HMO doesn't. My own sense without having detailed 
knowledge of it is also that anything that smacks of error and 
malpractice has greatly angered the providers on whom the 
insurers rely to deliver the services and they are reluctant to 
get into that.
    I think that the big employer plans and some of the big 
organized plans now are starting to and that is a very welcome 
development. What they can do is relatively limited compared to 
the people right there on the ground who have the clinical 
control and actually see things happen have the chance to catch 
things before they happen but there certainly are things that 
health plans and insurers could do. They are just somewhat more 
limited, I think, than what the clinicians and the organized 
systems that have hands on responsibility can do.
    Mr. Cox. I think, Mr. Bovbjerg, you mentioned in your 
testimony the extensive discoverability of information that 
would otherwise would be useful for correcting these problems 
of investigating errors, their causes and their potential 
remedies. Do you have any recommendations to make with respect 
to existing discovery rules?
    Mr. Bovbjerg. Well, I think I support the IOM panel's 
recommendation. If one really wants to provide confidence that 
things are not going to be discovered on an individual basis it 
is going to take a statute. There are protections. There are 
ways to interpret existing statutes at the State level to 
protect this type of scheme especially outside the institution 
but it is something of a stretch and I think that it is going 
to take both practical methods of protecting the data where you 
have some anonymous reporting, some identification of data, and 
probably some legal protection to really get a whole lot more 
reporting.
    Mr. Cox. Last, if I may, the emphasis of this panel and in 
fact the focus of this topic is on making the system or the 
aggregation of individuals working in healthcare in America 
work better and have better patient outcomes and fewer 
mistakes. The point that you have made I think competently is 
that if we focus more on systemic errors and problems in the 
delivery itself and less on blaming the individual nurse or the 
individual doctor or so on will actually do better.
    The tort lawyers come at this from a different point of 
view. They want to know who is going to pay in this case. Dr. 
Berwick mentioned enterprise liability as opposed to individual 
liability. How does that occur if nobody is to blame who works 
for the enterprise?
    Mr. Berwick. We are attributing the vast majority of 
hazards to systems. Somebody is responsible for the safety of 
those systems and that is the executive trustees and senior 
leaders of the enterprise. As individuals they may not be able 
to be reached but they are responsible.
    Mr. Cox. So would you then make them personally liable in 
litigation?
    Mr. Berwick. It is beyond my competence to say personally 
liable but I know the action to make patients safer has got to 
occur in the executive suite. If it doesn't start there, it 
isn't going to happen. That is why the VA has made----
    Mr. Cox. Well, let me make it a little easier to understand 
my question. If we are concerned about encouraging voluntary 
reporting, if people don't like voluntarily to report because 
they will then be to blame, if we are trying to resolve that 
problem by saying you are not to blame but we are going to make 
the enterprise liable, how do we ever make the enterprise 
liable if nobody that works there is to blame?
    Don't we have to--I mean doesn't the tort lawyer still have 
to go in and find out that something was wrong, that this 
system didn't work, this person who was responsible for it 
screwed up and as a result there was a bad outcome. Can it be 
possible that the enterprise was liable when nobody was at 
fault, when no person did anything wrong?
    Mr. Stearns. Let the gentleman's question--his time has 
expired.
    Mr. Cox. That is it for my question. It is up to the 
chairman whether you wish to expire the time for the answer.
    Mr. Stearns. Does anyone want to tackle that answer?
    Mr. Bovbjerg. The short answer is yes, I would be glad to 
talk with you on our time afterwards.
    Mr. Stearns. Okay. Well, I thank the first panel for their 
indulgence and it was very helpful. And now we will call up the 
second panel, which is Dr. Thomas Garthwaite, who is the Deputy 
Undersecretary of Health for Veterans' Affairs Administration, 
Dr. Bagian, who is Director of National Center for Patient 
Safety, Dr. Audrey Nelson, from the VA Hospital in Tampa, Dr. 
Janet Heinrich is from the GAO office, and Ms. Diane Cousins, 
who is Vice President of Practitioner and Product Experience 
Division of U.S. Pharmacopeia.
    So I welcome all of you to the second panel. We are 
delighted that you are attending, and we would appreciate your 
opening statement within the 5-minute time limit. And Dr. 
Garthwaite, you and I have had an opportunity on these 
discussion panels before so let me start off with you. Welcome.

   STATEMENTS OF THOMAS GARTHWAITE, DEPUTY UNDERSECRETARY OF 
HEALTH, VETERANS HEALTH ADMINISTRATION, DEPARTMENT OF VETERANS' 
AFFAIRS; ACCOMPANIED BY JAMES BAGIAN, DIRECTOR, NATIONAL CENTER 
   FOR PATIENT SAFETY; AUDREY L. NELSON, DIRECTOR OF PATIENT 
 SAFETY, CENTER OF INQUIRY, JAMES A. HALEY VA HOSPITAL; JANET 
   HEINRICH, ASSOCIATE DIRECTOR, HEALTH FINANCING AND PUBLIC 
HEALTH ISSUES, GENERAL ACCOUNTING OFFICE; AND DIANE D. COUSINS, 
 VICE PRESIDENT, PRACTITIONER AND PRODUCT EXPERIENCE DIVISION, 
                       U.S. PHARMACOPEIA

    Mr. Garthwaite. Thank you, Mr. Chairman. Thank you for 
inviting us to testify today on the critical issues of patient 
safety. Almost 3 years ago under the visionary leadership of 
Dr. Kenneth Kizer, who you have just heard from in the first 
panel, the VA began a major initiative to establish a system 
and a culture to improve the safety of our healthcare system, 
and by sharing our results, to improve the safety of healthcare 
for everyone.
    Our written testimony details our extensive efforts and I 
will not reiterate it. I would like to comment on VA's approach 
to three areas that continue to be debated--accountability 
systems versus learning systems, mandatory versus voluntary 
reporting, and public disclosure versus the need for candor.
    First, we all make errors. Healthcare providers certainly 
do. Dr. Bagian, who will speak to you next and who is an 
astronaut and a physician, can tell you that even rocket 
scientists make errors. Since the release of the Institute of 
Medicine report considerable debate has centered on finding an 
appropriate balance between assuring accountability for errors 
versus designing better systems to prevent errors and to 
minimize the consequences of errors. We believe that the 
institution delivering care has a responsibility to assume that 
individuals will make errors. Those institutions must find the 
systems that allow the errors to occur and improve the design 
of those systems.
    Those institutions also have a responsibility to detect 
incompetent providers and to take appropriate action. In VA we 
have sought to approach the error portion by first openly 
informing patients or families about errors. Second, to insist 
on mandatory reporting and analysis of adverse events within a 
process protected from public disclosure of individual patients 
and practitioners.
    Third, to identify early in a process any intentional 
unsafe acts for administrative review and action. Fourthly, to 
provide ongoing analysis of adverse events for possible 
systemic fixes and new standards including research at our 
patient safety centers of inquiry. Fifth, to implement new 
safety standards across our system and to share those broadly 
in the general healthcare sector. And, sixth, to sign 
performance contracts with our senior executives holding them 
accountable to implement new processes and procedures to 
improve patient safety.
    On the accountability side of the systems versus 
individuals issue, we continue to hold individuals accountable 
for their competence through a set of other processes including 
credentialing, privileging, re-privileging, administrative 
investigations, performance management systems, personnel 
management systems, reporting to State licensing bodies and 
reporting tort claim information in the National Practitioner 
Data Bank.
    A second issue that has triggered considerable debate is 
whether reporting should be mandatory or voluntary. The expert 
panel, which helped design our system and the experience of the 
aviation industry, led us to conclude that both systems are 
important and together yield more useful information than 
either can alone.
    A third issue which has been central to many of the 
discussions of what should be done to improve patient safety is 
a need to find the balance between the public's right to have 
information to choose a safe healthcare system for their care 
versus the need to create a culture of open disclosure without 
blame of individuals for system weaknesses.
    Take mandatory reporting of error rates as an example. 
Since the occurrence of error is not always obvious and is more 
likely in more highly complex and technical procedures, error 
rates would be predicted to be highest in systems that take 
care of the most medically complex patients, that perform the 
most advanced procedures, and that have the most aggressive 
reporting systems. These are often the systems that we would 
want to use for our own treatment. Yet, simple reporting of 
error rates would mislead us.
    We believe that additional study will be necessary before 
meaningful data that guide rather than mislead the public will 
be available. VA has chosen to use its unique position as a 
publicly accountable healthcare system to lead in the effort to 
insure the safety of patients. We also use our strengths as a 
major research and educational organization to conduct research 
on safety and to add human factors and organizational design to 
the curriculum of clinical administrative students in the VA. 
Thank you.
    [The prepared statement of Thomas L. Garthwaite follows:]
Prepared Statement of Thomas L. Garthwaite, Deputy Under Secretary for 
                 Health, Department of Veterans Affairs
    Mr. Chairmen and Members of the Committees, I am pleased to appear 
before you to discuss VA's ongoing activities and initiatives to ensure 
the safety of patients who receive care from VA. In December 1999, the 
Institute of Medicine (IOM) released a report ``To Err is Human: 
Building a Safer Health System.'' The report reviewed existing studies 
and concluded that as many as 98,000 preventable deaths occur each year 
in United States' healthcare due to error. The IOM recommended creating 
a new National Center for Patient Safety that would focus on research 
and policy related to errors in healthcare, improved error reporting 
systems, improved analysis/feedback methods, performance standards for 
healthcare organizations and individuals, and other specific 
governmental actions. Importantly, they cautioned that the focus must 
be on creating a culture of safety that will require improving systems, 
not assign blame.
    VA interpreted the IOM report as a validation of our commitment to 
improving patient safety in our healthcare system. All of the IOM 
recommendations applicable to VA have either been in place or were in 
the process of being implemented prior to the release of the report. 
While VA has had quality and safety related activities ongoing for many 
years, it was in 1997 that our formal patient safety program was 
launched (see Attachment 1). Leaders in the field of patient safety and 
medical error outside VA have participated in the design of our system 
and recognize VA as a pioneer in these efforts.
    During 1997, VA intensified its already extensive efforts in 
quality improvement by launching a major initiative on patient safety. 
We recognized that programs to improve quality and safety in healthcare 
often share purpose and corrective actions. However, we believed that 
patient safety required a new and different approach. We set out to 
create a new culture of safety in which our employees detect and tell 
us about unsafe situations and systems as part of their daily work. 
Once we know about unsafe situations and systems, we are committed to 
design and implement new systems and processes that diminish the chance 
of error.
Highlights of Patient Safety Activities at VA: 1997-Present
    VA recognized that patient safety is not a VA-specific issue, 
therefore we asked other health care organizations to join us in an 
effort to understand the issues and to act for patient safety. As a 
result, the National Patient Safety Partnership (NPSP), a public-
private consortium of organizations with a shared interest and 
commitment to patient safety improvement, was formed in 1997. The 
charter members, in addition to VA, included the American Medical 
Association, the American Hospital Association, the American Nurses 
Association, the Joint Commission on Accreditation of Healthcare 
Organizations, the Association of American Medical Colleges, the 
Institute for Healthcare Improvement, and the National Patient Safety 
Foundation at the AMA. Five additional organizations have subsequently 
joined the charter members in the Partnership: the Department of 
Defense Health Affairs, National Institute for Occupational Safety and 
Health, the Food and Drug Administration, Agency for Healthcare Quality 
and Research, and the Health Care Financing Administration. This group 
addresses high impact issues that are of importance to a broad cross 
section of the healthcare industry. An example of the Partnership's 
activity was the establishment of a clearinghouse for information 
related to the effect of Y2K computer issues on medical devices. The 
NPSP also called public and industry attention to Preventable Adverse 
Drug Events and promulgated simple actions that patients, providers, 
purchasers and organizations could take to minimize their chance of an 
adverse drug event. (See Attachment 2) The partnership serves as a 
model of what a private-public collaboration can do to improve patient 
safety.
    In 1998, VA created the National Center for Patient Safety (NCPS) 
to lead and integrate the patient safety efforts for VA. As the IOM 
report advises, VA created this center as a commitment to patient 
safety as a corporate priority with a direct reporting relationship to 
the Under Secretary for Health. The NCPS employs human factors 
engineering and safety system approaches in its activities. The first 
task for the Center was to devise systems to capture, analyze and fix 
weaknesses in our systems that affect patient safety.
    We sought to design reporting systems that would identify adverse 
events that might be preventable now or in the future. In addition, we 
sought systems to identify and analyze situations or events that would 
have resulted in an adverse event if not for either luck or the quick 
action of a healthcare provider--we call such events ``close calls.'' 
We believe that ``close calls'' provide the best opportunity to learn 
and institute preventive strategies, as they will unmask most system 
weaknesses before a patient is injured and avoid the liability issues 
implicit in investigation of injury. This emphasis on ``close calls'' 
has been employed by organizations outside of healthcare with great 
success.
    VA consulted with experts (Expert Advisory Panel for Patient Safety 
System Design) obtaining advice to enhance the design of VA's reporting 
systems. These experts in the safety field included Dr. Charles 
Billings, one of the founders of the Aviation Safety Reporting System, 
as well as other experts from NASA and the academic community. They 
advised us that an ideal reporting system a) must be non-punitive, 
voluntary, confidential and de-identified; b) must make extensive use 
of narratives; c) should have interdisciplinary review teams; and d) 
most importantly, must focus on identifying vulnerabilities rather than 
attempting to define rates of error. VA has used these principles to 
design the patient safety reporting systems we have in use or in 
development.
    Based on the expert advice and on lessons learned from our first 
generation mandatory adverse event reporting, the NCPS has developed a 
comprehensive adverse event, close call analysis and corrective action 
program which includes an end-to-end handling of event reports. This 
system not only allows for the determination of the root causes, but 
also captures the corrective actions as well as the concurrence and 
support of local management for implementation. The system includes a 
number of innovations such as algorithms and computer aided analysis to 
determine the root cause of adverse events and close calls. The Joint 
Commission on Accreditation of Healthcare Organizations and the 
American Hospital Association are currently evaluating parts of the 
system for use.
    The improved event reporting system is being pilot tested in VA's 
VISN 8. Extensive training is used as the new system is introduced to 
assure full understanding of the search for the root cause and redesign 
of the system. To date, response from the pilot site is positive. The 
quality managers and clinicians using the system believe that the new 
methods analysis of error will make a significant difference in the 
care of veterans.
    A complementary, de-identified voluntary reporting system is in the 
process of being implemented. It is patterned after the highly 
successful Aviation Reporting System that NASA operates on behalf of 
the FAA. It will be external to VA and will allow employees and 
patients to report unsafe occurrences without fear of administrative or 
other action being taken against them.
    Based on lessons learned, VA has promulgated specific procedures 
and policies aimed at reducing risk of error. These include such things 
as restricting access to concentrated potassium chloride on patient 
care units, use of barcode technology for patient identification and 
blood transfusions in operating rooms, and for verification procedures 
prior to injection of radio-labeled blood products. (Attachments 3-6) 
Based on the observation of a VA nurse when she returned a rental car, 
VA developed a system for using wireless bar coding to improve 
medication administration. That system was piloted at the Topeka VA 
Medical Center and will be in all VA hospitals by June of this year. At 
least two-thirds of medication errors can be prevented with this 
system.
    In 1999, VA established four Patient Safety Centers of Inquiry. 
These Centers conduct research on critical patient safety challenges. 
Activities at the Centers of Inquiry range from fall prevention and 
operating room simulators to understanding the role of poor 
communication in patient safety. The Center in Palo Alto, which is 
affiliated with Stanford University, is a recognized leader in the area 
of simulation and has been featured prominently in the media. Their 
simulated operating room allows surgeons and anesthesiologists to train 
and do research without endangering a patient. VA expects to create 
additional simulation facilities to train its physicians and other 
healthcare professionals. One simulator with appropriate staff could 
train about 600 anesthesiologists and residents-in-training per year. 
This means that virtually all VA anesthesiologists/anesthetists can be 
trained in a year on clinical situations that could not be simulated 
safely in patients. As a result of analyzing common variations during 
simulated operations, the center has developed a checklist card of 
facts that should be kept close at hand. These checklist cards will be 
attached to all anesthesia machines across VA.
    VA is partnering with the Institute for Healthcare Improvement to 
build learning collaboratives aimed at reducing medication errors, a 
major issue identified in the Institute of Medicine report. IHI 
collaboratives will affect several hundred VHA personnel each year. 
Other IHI collaboratives have resulted in measurable improvements and 
similar results are anticipated with medication errors.
    Another key VA strategy to reduce medical errors involves the 
development of a new curriculum on safety. VA is moving forward with 
plans to provide education and training relevant to patient safety not 
only to those already in practice but also at the medical, nursing, and 
health professional school level. This will be the first time an 
extensive safety curriculum will be developed and broadly implemented. 
VA is particularly well situated to lead the educational effort due to 
the extensive role it plays in the education of healthcare 
professionals in the United States. (VA is affiliated with 105 medical 
schools and up to one-half of all physicians train in a VA facility 
during medical school or residency.) Additionally, we have instituted a 
performance goal and measure to provide VA employees 20 hours of 
training on patient safety this year.
    VA instituted a Patient Safety Improvement Awards Program to focus 
interest on and reward innovations in identifying and fixing system 
weaknesses. Not only does this produce ideas for patient safety 
improvements that might otherwise go unnoticed but it further 
reinforces the importance that VA places on patient safety activities. 
(Attachment 7)
    In 1995, VA instituted a Performance Measurement System that uses 
objective measures of patient outcomes to set goals and reward 
achievement. Since 1998, VA has incorporated a performance goal and 
measure for its executives for accomplishment in patient safety 
activities. Last year, each network had to implement three patient 
safety initiatives to be fully successful and six initiatives to be 
outstanding.
    Other performance goals and measures assess the use of Clinical 
Practice Guidelines. By holding entire medical centers and geographic 
networks responsible for measured outcomes, we are able to institute 
reminder systems and redundancies that lead to dramatic improvements in 
performance. For example, patients who receive medications known as 
``beta-blockers'' following a heart attack are 43 percent less likely 
to die in the subsequent two years and are rehospitalized for heart 
ailments 22 percent less often. A goal of providing this therapy to 80 
percent of eligible patients has been set in the private sector, and 
recent medical literature reports rates of use as low as only 21 
percent in some settings. In the VA, over 94 percent of heart-attack 
patients receive this life-saving medication.
    Another example of the power of using systems rather than relying 
on individual adherence to clinical guidelines is in immunization. It 
is estimated that 50% of elderly Americans and other high-risk 
individuals have not received the pneumococcal pneumonia vaccine 
despite its demonstrated ability to minimize death and hospitalization. 
VA's emphasis on preventive healthcare has led to achieving pneumonia 
vaccination rates that exceed standards set for HMOs by almost 20% and 
nearly double published community rates. Similar accomplishments have 
been achieved in providing annual influenza vaccinations.
    We believe that patient safety can only be achieved by working 
towards a ``culture of safety.'' Patient safety improvement requires a 
new mindset that recognizes that real solutions require an 
understanding of the ``hidden'' opportunities behind the more obvious 
errors. Unfortunately, systems' thinking is not historically rooted in 
medicine. On the contrary, the field of medicine has typically ascribed 
errors to individuals and embraced the name-blame-shame-and-train 
approach to error reduction. Such an approach by its very name 
forecloses the opportunity to find systems solutions to problems. Other 
industries such as aviation have recognized the failings of this 
approach and over many years have succeeded in transitioning from a 
similar blame and faultfinding approach to a system-based approach that 
seeks the root causes of errors. VA realized how pivotal culture is to 
improving safety and in 1998, conducted a culture survey of a sample of 
employees. Of interest, the shame of making an error was a more 
powerful inhibitor of reporting than was fear of punishment. Employees 
readily forgave mistakes in others but were intolerant of their own. We 
plan to survey culture broadly in VA for several years to track the 
progress of our efforts.
    VA created a database of adverse events and asked our Medical 
Inspector to review it. The report has been widely, yet often 
inaccurately, quoted or critiqued in the media. The database was 
created to discover common and important adverse events in order to 
focus our efforts in patient system redesign. Commonly, the media 
assumed that all the adverse events (and deaths) were due to error. 
They were not. Neither the report nor the database cataloged which 
adverse events were preventable with today's state of knowledge and 
therefore could be characterized as errors. For example, most of the 
adverse events were falls, suicides and fatal events (attempted 
suicides, suicide gestures), or medication errors. It is not possible 
with today's knowledge to operate a national system of nursing homes 
and acute-care hospitals treating the elderly and chronically ill 
without a number of falls. Yet, we know that it is important to look 
for common factors to allow us to reduce the frequency of falls in the 
future. Similarly, psychiatrists have tried unsuccessfully to predict 
which patients will commit suicide. By looking at our data we hope to 
be able to predict high-risk patients in the future and therefore be 
able to prevent suicides. We have already learned that men with a 
recent diagnosis of cancer, who live alone and who own a gun, are more 
likely to commit suicide. We plan to study the use of additional 
interventions in this subgroup of patients at high risk of suicide.
Conclusion
    With no successful models in large healthcare systems to guide us, 
VA turned to other high risk, high performance industries to learn 
principles for safety. We have borrowed both methods and people from 
safety-conscious settings such as aviation and space travel and from 
underutilized disciplines like human factors engineering. These efforts 
have already produced significant improvements in VA, and we believe 
will do the same in all healthcare settings.
    We would prefer that all of healthcare had begun to address the 
issue of patient safety long ago. For too long, the emphasis has been 
on holding individuals accountable and hoping that well-intended and 
well-educated professionals wouldn't make human mistakes. As the IOM 
aptly states in the title of its report: ``To err is human.'' We are 
pleased to be on the leading edge as healthcare takes a systems 
approach to patient safety. We are anxious to discover new ways to make 
VA and all healthcare safer. We appreciate your support of these 
efforts and intend to keep you fully informed of our progress.


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    Mr. Stearns. Dr. Bagian, we had assumed that the two of you 
would be together. Did you have an opening statement that is 
more abbreviated? We are hoping that since you are accompanying 
Dr. Garthwaite that the two of you would share the 5 minutes. 
Maybe that was not explained to you so if not, I would be very 
happy to offer you an opening statement but I prefer it not to 
be a full 5 minutes.
    Mr. Bagian. I will try to be as brief as I can, sir, if 
that is okay.
    Mr. Stearns. Sure.

                    STATEMENT OF JAMES BAGIAN

    Mr. Bagian. Let me just get to the response to some of the 
comments that were made earlier. First, we certainly think 
reporting is important but one has to remember the purpose for 
reporting as has been mentioned earlier is what you learn from 
the reports and then what you do to prevent the problem. The 
real key is at the end of the line after the report occurs, 
what do you do about it. A report by itself doesn't do very 
much.
    We looked at both mandatory and voluntary reporting systems 
and we think both are important and we have actually a 
mandatory system that is in place but we have tried to encase 
in that system some of the qualities that we believe make it 
more successful, that is, that we make a very clear definition 
for the people that report so they understand how it will be 
used so they are not fearful. In fact, one of the ways we 
understood this better was we did cultural surveys and 
published these results almost a year and a half ago 
approximately.
    One of the things we found was that people's reticence to 
report was not just that they fear punishment, deliberate 
punishment, but it was shame. When we asked people are you 
ashamed if other people know you have erred 49 percent said 
yes, they were ashamed. They strongly agreed that shame was the 
barrier. Whereas when we asked them on the other hand how do 
you view others that have erred, only 4 percent held that 
against them, thought less of them for that.
    So it points out that it is not just through rules that say 
you will be held harmless from punishment, it is actually the 
opinion of your peers or your colleagues that has a large role. 
The role of close calls also was mentioned earlier. I don't 
think that is the term that was used but that is the event that 
doesn't occur where disaster or tragedy is averted at the last 
moment. That is something where you can learn quite a bit. In 
aviation they have shown that often you can get even more 
information that is of value from a close call because people 
are more likely to honestly talk about that and openly, because 
no disaster occurred and they actually saved the day at the 
last minute.
    One has to be aware when you have these kind of reports, 
and there is data out there, in one particular series they 
showed in an industrial setting where they had close call 
reporting when they just started to institute it, they had 
about one close call for every 233 employees. Four years later 
after they had emphasized this is an important modality, they 
had one close call every 54 employees, almost a five fold 
increase.
    Now if someone mentioned on the news, you could imagine the 
report that night could be, wow, this industry is out of 
control because they have had a five fold increase in close 
calls but in fact if you look at the outcome they were 
measuring which was lost time injuries. Lost time injuries were 
reduced by two-thirds at the same point. The emphasis here is 
not on the number of reports. It is on what you do with those 
reports and how you reduce your vulnerability. Reporting 
systems tell you vulnerabilities and as Mr. Smith pointed out 
``we want to have good statistics.''
    It is hard to know the denominator, that is, the incidence, 
but one is even too much and if you can identify a systems 
problem then you aggressively attack that and we put processes 
in place to do just that and follow through with the 
accountability piece at the management level as Dr. Berwick 
spoke about earlier. So we think the key is to understand 
reporting systems or vulnerabilities and then what do you do 
about it. That the important thing is to get closure. And while 
we will never have full reporting, we never will, nobody ever 
can, you want to do the best you can with that to make things 
better and we think that can be done. And I will stop there.
    Mr. Stearns. Dr. Nelson.

                   STATEMENT OF AUDREY NELSON

    Ms. Nelson. Mr. Chairman and members of the committee, I am 
very pleased to appear before you to discuss one VA innovation, 
specifically the Patient Safety Center of Inquiry located in 
Tampa, Florida. I am the Director of that center and I am a 
nurse researcher by background. Funded for 3 years starting in 
March, our center focuses on safe mobility for frail elderly 
and persons with disabilities, two very vulnerable patient 
groups.
    Our research area is to look at preventing patient falls 
and promoting safe wheelchair transfers. The unique aspects and 
strengths of our center I will summarize in five points. First, 
we have a state-of-the-art biomechanics laboratory which allows 
us to very carefully analyze risks related to falls and 
dynamics of patient wheelchair transfers. This lab was funded 
by the VA 2 years ago.
    Second, the problems that we are studying affect many 
Americans, not just veterans. Therefore, we have made it a 
point of partnering with industry, public, government agencies, 
and, more importantly, consumers in solving some of these very 
practical problems. Third, problems that affect veterans happen 
more commonly with regard to falls in the community, not in 
hospitals, and we are making it a real point to come up with 
solutions that are appropriate for veterans living in the home 
as well as those that are in long-term care facilities or 
hospital-based settings.
    An example is the project that we have just submitted on an 
evidence-based practice fall prevention program which looks at 
instituting a community-based fall program in all VISN 22 and 
VISN 8. Fourthly, our research center has taken a very 
practical approach not only to conducting research but also in 
getting that research out and into clinical practice and 
embedded into what people are doing in a very quick fashion. We 
are product-oriented. We are working at developing clinical 
pathways, protocols, resource guides, new equipment and other 
techniques and devices that have immediate application.
    Last, our center is somewhat unique in that we are looking 
to technology for answers. We have partnered with a variety of 
disciplines outside the traditional healthcare arena to help us 
in looking at new technology and new answers for preventing 
some of these injuries and issues. An example is our work in 
developing a safe patient room of the future which will be 
housed at the Museum of Science and Industry which looks at 
integrating patient care equipment across all of patient care 
activity domains in a safe fashion that would support patient 
independence as well.
    In summary, finding these patient safety centers of inquiry 
have encouraged us to develop a cadre of researchers dedicated 
to patient safety topics. This will accelerate the pace of 
learning and the application of this research to practice. 
Thank you.
    [The prepared statement of Audrey L. Nelson follows:]
Prepared Statement of Audrey L. Nelson, Director, VISN 8 Patient Safety 
          Center of Inquiry, James A. Haley Veterans Hospital
    Mr. Chairmen and Members of the Committees, I am pleased to appear 
before you to discuss an example of a VA innovation to support patient 
safety, the establishment of Patient Safety Centers of Inquiry. Our 
center is one of the four centers that were funded for three years 
starting in March 1999. The VISN 8 Patient Safety Center of Inquiry 
focuses on Safe Mobility for Frail Elderly and Persons with 
Disabilities. Specifically, our center's focus is on efforts to prevent 
patient falls and promote safe wheelchair mobility. Falls are a 
critical problem in health care, accounting for 25% to 84% of all 
adverse events in hospitals.
    The mission of our center is to support clinicians in providing 
safe patient care by designing and testing clinical innovations, 
technological solutions, and patient safety improvement systems. Our 
research efforts will target two patient populations with compromised 
mobility: frail elderly and persons with disabilities.
    We have identified two primary goals: (1) to improve functional 
status and quality of life for frail elderly and persons with 
disabilities by addressing mobility enhancement and safety issues, and 
(2) to build a ``culture of safety'' to support clinicians in providing 
safe patient care and safe working environments. To address these 
goals, our research efforts have focused in four key areas:

 Develop and Test Clinical Innovations Related to Safe Mobility
 Design Technological Solutions Related to Safe Mobility
 Redesign Patient Safety Systems
 Facilitate Innovation Diffusion
    Our center includes staff with expertise in a variety of 
disciplines, including: architecture, computer science, epidemiology, 
ergonomics, industrial design, health economics, industrial 
engineering, interior design, law, mechanical engineering, medical 
equipment manufacturing, medicine, nursing, social sciences, technology 
brokerage, and quality/risk management. Many of our project teams 
include consumers.
    We are actively collaborating with partners in industry and 
government, as well as public and private sectors. In addition to 
consumers, key partners include: ARJO,' the Joint Commission 
on Accreditation of Health Care Organizations (JCAHO), Food and Drug 
Administration (FDA), Museum of Science and Industry, Paralyzed 
Veterans of America (PVA), University of South Florida, VA Healthcare 
Analysis & Information Group, and VHA Office of Quality & Performance. 
In the future, we plan to partner with the Agency for Healthcare 
Research & Quality (AHRQ), National Institutes of Health (NIH), and the 
National Aeronautics and Space Administration (NASA).
    We have a number of projects underway to address safe mobility. A 
few of these projects are outlined below:

 Establish Gait and Balance Clinics to prevent falls in high 
        risk veterans
 Evaluate Tai Chi as a strategy for Fall Prevention
 Evaluate a Tele-monitoring program to Prevent Falls for 
        Veterans with Parkinson's Disease
 Develop a Resource Guide to Identify Alternatives to Bed Rails 
        for Frail Elderly
 Develop a Resource Guide for Safe Patient Movement
 Develop Clinical Pathways to prevent falls
 Design an Evidence-Based Program for Fall Risk Assessment & 
        Prevention
 Convene an Expert Panel to set Research Agenda for Patient 
        Falls
 Evaluate Fall Risk Assessment Tools
 Develop Clinical Practice Guidelines to Preserve Upper 
        Extremity Function in Wheel Chair Users
 Pilot test the National Patient Safety Handbook
 Identify barriers to reporting patient safety incidents/near 
        misses
 Describe the epidemiology of falls in a variety of health care 
        settings
 Develop a report on the direct and indirect costs of patient 
        falls in VA
 Conduct a biomechanical assessment of safe wheelchair 
        transfers to preserve upper extremity function in persons with 
        spinal cord injuries
 Conduct a biomechanical assessment of the gait of individuals 
        who repeatedly fall
 Redesign patient lifting equipment to prevent patient and 
        caregiver injuries
 Participate on the AHRQ sponsored Expert Panel to set the 
        Research Agenda for Health Care Environments
 Establish a Consensus Validation Conference for ``Technology 
        to Support Safe Patient Care'' (hope to partner with VA's 
        Rehabilitation Research & Development Service, NIH, AHRQ, 
        NIOSH)
 Establish a web-based VA Safety Information Center
 Design of a safe patient care room of the future, evaluate its 
        effectiveness in the VA healthcare environment, and display 
        this prototype at the Museum of Science and Industry
Conclusion:
    We believe that VA deployment of resources and expertise will allow 
us to address the significant safety challenges related to safe 
mobility for frail elderly and persons with disabilities. Our efforts 
will impact persons living in the community as well as persons in 
acute, long-term care, or assisted living facilities. We are working 
closely with consumers, as well as partners in industry, government 
agencies, and the private sector to provide practical solutions to 
patient safety problems. We will work with VA's National Center for 
Patient Safety to disseminate these innovations throughout VHA, the 
larger health care arena, and to the general public. We appreciate your 
support of these efforts, and would be delighted to share our progress 
in the future.

    Mr. Stearns. Dr. Heinrich, welcome. Just pull that 
microphone right close to you. Thank you.

                   STATEMENT OF JANET HEINRICH

    Ms. Heinrich. I am pleased to have the opportunity to 
testify as you consider adverse medical events in our 
healthcare system. Adverse events have been receiving 
considerable attention with the report of the Institute of 
Medicine ``To Err Is Human''. Efforts to identify adverse 
events and evaluate the causes are important strategies to 
reduce harm to patients. Recent GAO reports have considered a 
range of surveillance systems for medical products. These 
studies have implications for the design of surveillance 
systems to detect adverse events and medical errors.
    First, while adverse events are recognized as a serious 
problem, the full magnitude of the threat to the health of the 
American public is not known. The best information we have on 
the incidence of adverse events of all types comes from the two 
studies that have been mentioned, the first, from the sample of 
medical charts in New York, and the second in Colorado and 
Utah. That is where the widely cited estimate of 44,000 to 
98,000 deaths per year attributed just to medical errors comes 
from.
    And they do extrapolate the numbers from these studies to 
the rest of the country, not taking into account the variation 
in clinical practice patterns. There is even less information 
known about adverse events in ambulatory settings or other 
health care settings. Second, the task of gathering valid 
information about adverse events is an extremely difficult one. 
All systems that rely on healthcare providers to take the 
initiative to make a report, in other words, both passive and 
spontaneous reporting systems, have serious limitations and 
this is true whether or not providers are required to report 
these events.
    In our review of the research on adverse drug events, we 
learned what is known about the strengths and limitations of 
these reporting systems. It is well known that all spontaneous 
reporting systems experience a high level of under reporting. 
For example, the FDA believes that its system for gathering 
voluntary information about adverse drug events receives 
reports for no more than 10 percent of all events. And the 
States that mandate adverse reporting receive highly variable 
numbers of reports for example, approximately 15,000 in New 
York and 4,000 in California, even though California has 72 
percent more people.
    And certainly the VA in its report of its system also 
experienced significant variability in reporting. Commonly 
cited reasons for under reporting include fear of being blamed, 
the potential for legal liability or an expectation that the 
report will have no effect. Protecting the confidentiality of 
reports, reporters and information, is often suggested as a way 
to increase reporting.
    A pilot study conducted by FDA on adverse events for 
medical devices included confidentiality of reporters as one 
component. Adverse event reports increased by tenfold, but it 
was much harder to follow up on missing or ambiguous 
information. A truly confidential reporting system places a 
significant burden on reports to contain all information needed 
to follow up in protecting the public's health. Under reporting 
is only part of the problem. We also know that there is a 
significant bias in terms of which events are reported. In the 
area of drug-related events, we found that a wide variety of 
factors such as how long a drug had been on the market could 
affect the likelihood of reporting.
    To get valid and complete information on the incidence of 
adverse events we need data that do not come from a spontaneous 
reporting system. This requires a proactive examination of 
random samples of patients and their records as was done in New 
York, and Colorado and Utah. Many of the injuries suffered by 
patients as a result of medical treatment are not due to errors 
but reflect the inherent risk of treatments that are 
administered correctly. It can be difficult to identify these 
adverse reactions and to distinguish them from medical errors 
or from the course of the patient's illness. We know, for 
example, that one-half to two-thirds of adverse drug events 
occur when drugs have been used appropriately. Events that 
result from what is deemed appropriate treatment need study so 
that better treatment guidelines can be developed.
    In conclusion, surveillance systems that uncover and 
document adverse events can collect valuable information but 
they are not sufficient by themselves to improve medical care. 
The data need to be carefully analyzed and interpreted to 
create a good understanding of the reasons why events occur. A 
thoughtful analysis can lead to the specific changes in our 
healthcare systems that will reduce the likelihood of adverse 
events. This concludes my prepared remarks, Mr. Chairman, and I 
of course will be happy to answer any questions.
    [The prepared statement of Janet Heinrich follows:]
   Prepared Statement of Janet Heinrich, Associate Director, Health 
   Financing and Public Health Issues, Health, Education, and Human 
       Services Division, United States General Accounting Office
    Mr. Chairman and Committee Members: I am pleased to have the 
opportunity to testify today as you consider issues related to adverse 
medical events in the nation's health care system. Adverse events are 
receiving considerable attention now as a result of the recent 
Institute of Medicine report on medical errors.1 Adverse 
events are injuries to patients caused by medical treatment; medical 
errors are mistakes in medical care that may or may not lead to harm. 
Efforts to identify adverse events and evaluate their causes are 
important components of strategies to reduce harm to patients. Several 
of our recent reports have considered surveillance systems for medical 
products, particularly drugs and medical devices. For example, last 
week we released a report that synthesizes current research on adverse 
drug events (ADE).2 We have also evaluated the Food and Drug 
Administration's (FDA) system for monitoring problems with medical 
devices.3
---------------------------------------------------------------------------
    \1\ Institute of Medicine, To Err Is Human: Building a Safer Health 
System (Washington, D.C.: National Academy Press, 1999).
    \2\ Adverse Drug Events: The Magnitude of Health Risk Is Uncertain 
Because of Limited Incidence Data (GAO/HEHS-00-21, Jan. 18, 2000).
    \3\ Medical Device Reporting: Improvements Needed in FDA's System 
for Monitoring Problems With Approved Devices (GAO/HEHS-97-21, Jan. 29, 
1997).
---------------------------------------------------------------------------
    In summary, I believe that the results of our work have important 
implications for addressing adverse medical events including the design 
of surveillance systems to detect adverse events and medical errors. 
First, while adverse events have been recognized as a serious problem, 
the full magnitude of their threat to the health of the American public 
is unknown. Second, gathering valid and useful information about 
adverse events is extremely difficult. For example, all systems that 
rely on health care providers to take the initiative to make a report--
known as passive or spontaneous reporting systems--have serious 
limitations. This is true whether or not providers are legally required 
to report adverse events; that is, both mandatory and voluntary 
spontaneous reporting systems share this limitation. Furthermore, many 
of the injuries patients suffer as a result of medical treatment do not 
stem from errors but reflect the inherent risks of treatments that are 
administered correctly. It can be difficult both to identify these 
adverse reactions and distinguish them from medical errors or from the 
course of a patient's underlying illnesses.
         little is known about the incidence of adverse events
    Relatively little information exists on the incidence of adverse 
events of all types, including, for example, those caused by drugs, 
medical device malfunctions, and diagnostic mistakes. Aside from small 
studies of individual institutions, the best available information 
comes from two studies of statewide samples of hospitalized patients. 
The first assessed adverse events in New York in 1984, and the second 
employed a comparable approach to examine the incidence of adverse 
events in Utah and Colorado in 1992.4 The widely cited 
estimate that 44,000 to 98,000 deaths per year are attributable just to 
medical errors comes from an extrapolation of the results of these two 
studies to the United States population as a whole. Although these 
studies are the best available, national estimates based on them have 
not taken into account regional variations in clinical practice 
patterns and patient characteristics.
---------------------------------------------------------------------------
    \4\ T.A. Brennan and others, ``Incidence of Adverse Events and 
Negligence in Hospitalized Patients: Results of the Harvard Medical 
Practice Study I,'' New England Journal of Medicine, Vol. 324, No. 6 
(1991), pp. 370-76, and E.J. Thomas and others, ``Incidence and Types 
of Adverse Events and Negligent Care in Utah and Colorado,'' Medical 
Care, forthcoming.
---------------------------------------------------------------------------
    The largest category of adverse events caused by medical treatment, 
about one-fifth of the total, consists of those brought about by drugs. 
Although it is clear that a wide range of commonly used drugs cause 
adverse drug events with potentially serious consequences for patients, 
relatively little is known about the frequency of ADEs. In part, this 
reflects the reality, which we discuss later, that identifying a 
medication as the cause of an adverse event can often be difficult and 
uncertain. Consequently, the available information on ADE incidence 
tends to be fragmentary and inconsistent. Data routinely collected on 
ADEs during clinical trials or after drugs have been marketed are 
intended to identify which ADEs are associated with particular drugs 
and do not focus on how often ADEs take place. Information on the 
overall incidence of ADEs from all drugs is limited to a few research 
studies that typically examine the experience of patients in one or two 
specific institutions--generally hospitals or sometimes nursing homes--
leaving the overall incidence of ADEs in outpatient care largely 
unexplored.
    The most broadly based information on ADE incidence comes from the 
two studies that I mentioned earlier. These studies applied a 
particularly restrictive definition of ADEs in finding that they 
occurred at a rate of 0.56 for every 100 patients admitted in Colorado 
and Utah and 0.72 per 100 admissions in New York. The studies counted 
only ADEs that resulted in disability, prolongation of a patient's 
hospital stay, or death, meaning that a significant fraction of the 
patients less seriously injured by drugs was omitted. Other studies 
that used broader definitions, but applied them in the context of 
specific institutions, found a range of 2 to 30 ADEs per 100 hospital 
admissions. There are still fewer published studies examining ADEs in 
nursing homes, and all are limited to one or two individual providers. 
Two of these studies reported an incidence of 0.44 to 0.71 ADEs per 
patient month, rates roughly comparable to the rate reported in one 
study of hospital ADEs that presented ADE incidence in terms of time 
spent in the hospital.
   useful and valid information about adverse events is difficult to 
                                 obtain
    Recent proposals to increase our understanding of adverse events 
have focused on improving adverse event reporting systems. However, 
some of the inherent limitations of these systems are difficult to 
overcome. Further, it can be difficult to ascertain whether patient 
injuries or harm come from adverse events or their underlying illness, 
and many adverse events are not the result of medical errors.
Limitations of Spontaneous Reporting Systems
    The Institute of Medicine has recently issued a set of 
recommendations on measures that the various components of the U.S. 
health care system can take to reduce the incidence of medical errors. 
Among their proposals was the suggestion that two types of medical 
error reporting systems be instituted: a mandatory system focusing on 
medical errors that resulted in serious injury or death and a voluntary 
system for reporting events in which errors occurred but led to at most 
minor injuries. While the proposal for voluntary systems has received 
widespread support, many provider and professional groups have raised 
concerns about establishing a national program of mandatory reporting 
of serious adverse events.
    In our recent review of the research on adverse drug events, we 
learned what is known about the strengths and limitations of adverse 
event reporting systems of both the mandatory and voluntary variety. It 
is well known that all spontaneous reporting systems experience a high 
level of underreporting. For example, FDA believes that its system for 
gathering information about ADEs, the Adverse Event Reporting System 
(AERS), receives reports for only about 1 to 10 percent of all ADEs. 
Indeed, FDA relies on AERS primarily to generate ``signals'' of new 
adverse drug events that the agency can then investigate through other 
data sources.
    Even mandatory systems can manifest extensive underreporting. For 
example, the Institute of Medicine collected detailed information on 
mandatory adverse event reporting programs in 13 states. According to 
these data, the state programs receive highly variable numbers of 
reports. For example, between 15,000 and 20,000 reports are submitted 
annually in New York, compared with approximately 4,300 in California. 
The Institute of Medicine did not cite any studies assessing the extent 
of underreporting in the various state programs, but it noted the 
general presumption that to varying degrees all are affected by it. 
Thus, no one knows at this point what proportion of reportable cases is 
actually reported to any of the state systems.
    There are many possible reasons for underreporting. Among those 
commonly cited are the fear of being blamed, the potential for legal 
liability, and an expectation that reports will not have any effect. In 
addition, depending on the definition of adverse events, and how that 
definition is interpreted, there may be considerable variability among 
health care providers and institutions about the kinds of events that 
are reported. Some of the examples of serious adverse events to be 
covered by the Institute's proposed mandatory reporting program are 
relatively unambiguous--a maternal death, for instance. But others, 
such as ``serious injuries associated with the use of a new device, 
operation, or medication,'' are not as clear because they are based on 
judgments of the causes of patient injury, not an easily observed 
clinical outcome.
    Various measures can be taken to address some of these 
disincentives to reporting and thereby increase the number of reports 
submitted. These include protecting the confidentiality of reporters 
and making it easier to file reports. Both were part of a pilot study 
FDA sponsored of a new system for collecting reports about adverse 
events for medical devices. That study received adverse event reports 
at a rate ten times greater than in the current medical device 
surveillance system, even though the current system mandates the 
reporting of the same types of events. However, because the reporters 
may be unknown in a confidential reporting system, it is much harder to 
follow up reports in order to clarify important information that may be 
ambiguous or missing. A truly confidential reporting system places a 
significant burden on adverse event reports to contain all the 
information that a regulatory agency, or a product's manufacturer, 
needs or will need in the future to understand the potential public 
health risk.
    Moreover, underreporting is only part of the problem. The bigger 
difficulty is that the subset of adverse events that are reported does 
not accurately reflect the universe of all adverse events. The 
available studies indicate that there is substantial bias in reporting. 
In the area of drug-related events, we found that a wide variety of 
factors could affect the likelihood of reporting. For example, more 
reports are received during a drug's first few years on the market than 
later, and drug manufacturers with extensive postmarketing surveillance 
efforts gather more reports than other companies do. Therefore, it is 
not legitimate to infer that patterns or trends that emerge in reported 
events reflect what is happening with adverse events overall.
    To get valid information on the incidence of adverse events, we 
need data that do not come from a spontaneous reporting system. This 
generally involves a proactive examination of a random sample of 
patient records, as was done in both the New York and Utah and Colorado 
studies that I mentioned earlier. In fact, the Institute of Medicine 
report supports having a new organization, a Center for Patient Safety, 
collect data on the incidence of adverse events through studies of this 
type. More such studies are needed if we are to have accurate data on 
the magnitude of the problem that adverse events represents.
    However, studies based on large, representative samples of patient 
records tend to be expensive and time consuming to complete. Therefore, 
there will always be the temptation to draw implicit inferences from 
the more readily available data from the existing adverse event 
reporting systems about where medical errors are most likely to occur 
and how much progress, if any, has been made in reducing them. The 
Institute of Medicine's recommendation to implement standard 
definitions and formats for the mandatory reporting of serious adverse 
events is likely to encourage greater reliance and use of those 
reports. Standardizing definitions cannot overcome the 
nonrepresentative quality of reported adverse events. Standardized 
definitions and formats will, however, enhance the utility of adverse 
reports for other types of analyses that are not concerned with 
incidence. For example, they will facilitate analyses of multiple 
instances of a particular type of adverse event. Such analyses can help 
identify the key underlying factors that explain why these adverse 
events occur.
    Even with the limitations of mandatory and voluntary reporting 
systems, the information they generate can help in reducing medical 
errors and associated adverse events. In some cases, the fact that a 
particular kind of adverse event occurred one or more times and has 
been reported is sufficient to motivate action and dictate its 
direction. In those cases, incident reporting systems can function 
effectively and may have substantial advantages. However, it is often 
important to understand the frequency of a particular type of error and 
whether that has changed over time. In these cases, the incomplete data 
coming from reporting systems may not be sufficient. It is better to 
rely then, if possible, on data that derive from an examination of a 
sample of patient records.
Many Adverse Events Are Not Caused by Medical Errors
    Efforts to reduce adverse events should not focus exclusively on 
those caused by errors. The available studies indicate that just over 
half of adverse events of all types are caused by errors in treatment. 
The study of New York hospital discharges found that 58 percent of 
adverse events were preventable, compared with 53 percent in the 
corresponding study of Utah and Colorado hospital patients. This means 
that nearly as many adverse events result from appropriate medical 
treatment as from errors.
    The proportion of adverse events involving drugs that is due to 
medical error is even lower. Available data suggest that one-half to 
two-thirds of ADEs occur when drugs have been used appropriately. Many 
of these ADEs are the result of a drug's known pharmacological 
properties and are often listed on the medication's label. For example, 
hemorrhaging is the most common adverse reaction for warfarin, a drug 
that reduces the risk of heart attack, stroke, and other conditions by 
decreasing the clotting ability of blood. Other adverse reactions, 
including allergic reactions, are less predictable, caused by 
sensitivities in individual patients who have no history of adverse 
reactions to a specific drug. Still other adverse reactions are related 
to previously undetected risks. These include drug-drug and drug-food 
interactions that become evident as a drug is used by many types of 
patients, having many kinds of concurrent illnesses, and taking many 
other medications, as well as over-the-counter drugs and dietary 
supplements. FDA's system for collecting voluntary reports on adverse 
experiences with marketed drugs is designed specifically to uncover 
these kinds of previously unknown risks.
    Many types of drugs can cause adverse reactions. Some drug classes 
are associated with a substantial number of adverse reactions mainly 
because they are prescribed to many patients. These include 
antibiotics, narcotic analgesics, drugs to control hyperglycemia in 
type II diabetics, psychotropic drugs such as antidepressants and 
tranquilizers, and nonsteroidal anti-inflammatory drugs (NSAIDs). 
However, some classes of drugs have notably lower rates of adverse 
reactions despite high rates of use. Antihistamines and the statin 
drugs prescribed to lower cholesterol levels are rarely associated with 
serious adverse reactions.
    Patients who are very ill, including those with several concurrent 
diagnoses, have a greater risk of adverse reaction than others do. Not 
only are they more fragile but their illnesses may require several 
simultaneous treatments. In addition, they may be receiving more 
aggressive treatments that are known to entail significant risks. Some 
reports have found that elderly persons and women have more adverse 
reactions than younger persons and men. However, it is possible that 
age and gender are merely related to other risk factors instead of 
independently increasing the likelihood of an adverse reaction. In some 
studies, controlling for the number of medications being taken 
substantially diminishes any relationship between age and adverse 
reactions.
    As with medical errors, passive surveillance systems are inadequate 
for measuring the frequency or rate of adverse drug reactions. Other 
kinds of studies are required to develop this information. Thus, 
adverse reactions that develop after the prolonged use of a drug 
require studies with long follow-up periods to determine whether the 
adverse events are related to the drug. Similarly, rare adverse 
reactions require studies with very large numbers of patients to 
accumulate a sufficient number of problematic cases, and adverse 
symptoms that mimic those of a patient's underlying condition require 
carefully controlled clinical trials. For example, the Cardiac 
Arrhythmia Suppression Trial found that antiarrhythmia medications 
doubled the risk of cardiac arrest and death in heart attack survivors. 
This was not detected in clinical practice (nor fully captured in 
spontaneous reporting systems) because patients with heart disease 
regularly have arrhythmias and heart attacks, providing a ready 
alternative explanation that masked the causal role of the drugs. It 
has been estimated that these medications caused up to 50,000 premature 
deaths.5
---------------------------------------------------------------------------
    \5\ See D.S. Echt and others, ``Mortality and Morbidity in Patients 
Receiving Encainide, Flecainide, or Placebo,'' New England Journal of 
Medicine, Vol. 324, No. 12 (1991), pp. 781-88.
---------------------------------------------------------------------------
    In conclusion, surveillance systems that uncover and document 
adverse events can collect valuable data, but they are not sufficient, 
by themselves, to improve medical care. The data need to be analyzed 
and interpreted to create a better understanding of the reasons for 
adverse events. Sometimes one adverse event, if carefully examined, can 
provide insights of this sort. At other times, analysts need to assess 
multiple examples of a particular type of event to discern the critical 
causal factors. However, for both types of analysis, the quality of the 
data that are collected is critical. Accurate information on the 
process of care provided and the patient's response to that care is 
required to determine the key factors that led to an adverse event. 
Thoughtful analyses can then use these data to identify specific 
changes in health care systems and processes that can reduce the 
likelihood of adverse events caused by both medical errors and the 
normal risks of adverse outcomes inherent in all medical interventions.
    This concludes my prepared statement, Mr. Chairman. I will be happy 
to respond to any questions that you or members of the committees may 
have.
Contacts and Acknowledgments
    For future contacts regarding this testimony, please call Janet 
Heinrich at (202) 512-7119. Key contributors include Martin T. Gahart 
and Eric A. Peterson.

    Mr. Bilirakis. Thank you very much, Doctor. Ms. Cousins. 
Please pull that microphone closer, if you would.

                  STATEMENT OF DIANE D. COUSINS

    Ms. Cousins. Good afternoon, Mr. Chairman, and members of 
the committees. I thank you for this opportunity to testify 
today. My name is Diane Cousins. I am a pharmacist and the Vice 
President for the Practitioner and Product Experience Division 
of the United States Pharmacopeia. I have directed this 
division for the past 18 years. USP is a not-for-profit 
organization whose sole mission is to promote the public 
health. USP establishes and disseminates legally enforceable 
standards of quality for medicines and related articles 
including nutritional supplements, herbals and blood products.
    USP's expertise as a standard-setting body is recognized in 
Federal law. Thus, USP has for many years participated in a 
public, private relationship, a very unique one, with the 
Federal Government, especially the FDA. Since 1971, USP has 
operated reporting programs as a free service to health 
professionals in support of our standard-setting activities. As 
a partner in the FDA's Med Watch program, USP shares all its 
reports with the FDA at no cost to the government.
    Since 1991, the USP has operated a medication errors 
reporting program, a spontaneous practitioner-based system in 
cooperation with the Institute for Safe Medication Practices. 
The program has collected more than 4,000 reports that have 
identified errors in various healthcare settings, including 
retail pharmacies, nursing homes and home healthcare. Through 
the program we found that errors can be committed by 
experienced and inexperienced staff, by health professionals, 
support staff, students, and even patients and their 
caregivers.
    The causes of error may be due to human error, to product 
names or design or to the medication handling and delivering 
systems in which individuals operate and interact. In August 
1998 USP developed a complimentary program to the medication 
errors reporting program called MedMARx. USP found that 
hospitals would be willing to submit reports if reporting could 
be done anonymously and in a standardized format that would 
allow them to track, trend and compare their experiences to 
other participating hospitals.
    Today I have been asked to demonstrate MedMARx to the 
committees. Although this is a slide presentation MedMARx is 
actually an Internet program. When hospitals first access 
MedMARx, the system randomly assigns a specific permanent 
facility ID which becomes the hospital's pin number of sorts in 
the system. Although USP knows what hospitals are enrolled and 
what IDs are in the system, USP has no way to match a hospital 
to a specific facility ID thereby maintaining anonymity.
    After entering MedMARx for the first time hospitals create 
a facility profile which captures characteristics such as bed 
size, type of facility, staffing, and services offered for both 
inpatient and outpatient. MedMARx includes hospitals of bed 
sizes ranging from under 25 to more than 800. Currently over 
150 hospitals are participating including institutions of the 
Department of Veterans' Affairs and the Department of Defense. 
MedMARx uses a standardized definition of medication error. Our 
experience shows that hospitals define errors differently.
    For example, some hospitals define error as deviation from 
the prescriber's order, thus presuming the order is correct. 
Other hospitals only capture errors in administration and not 
in dispensing or prescribing. As the GAO report on adverse drug 
events notes, a broad definition for error means that the total 
number of errors will inherently be higher. Using a 
standardized category index hospitals classify errors on the 
severity of outcome to the patient. Four of the nine categories 
are shown here and include potential errors in category A and 
near misses in category B.
    Category C and D errors reach the patient but do not cause 
harm. The remaining categories reflect some degree of harm 
including fatalities. Note that all errors from potential to 
fatal are captured in a single data base providing added value 
to MedMARx users. The next four slides capture the fields for 
basic report entry. The volume of data captured in each report 
is tiered so that more data is collected as the severity of the 
outcome increases.
    MedMARx's data shows that most common types of error are 
missed doses and wrong doses. MedMARx captures causes of 
errors, contributing factors and location of the error. The 
data show that a top cause of error is performance deficit 
meaning that healthcare professionals were trained to know 
better yet erred nonetheless. Contributing factors reportedly 
associated with this cause are distractions and workload 
increase, an important point in this environment of cost 
containment.
    Because MedMARx was designed as a systems approach to 
medication error reduction the program does not capture names 
of individuals involved in the error but rather examines the 
level of staff involved in the error which provides opportunity 
for focus policy development, training and education. These 
final fields and basic record entry capture the learning that 
can be achieved by reporting to a national data base. Hospitals 
are not only able to see the errors entered by other hospitals 
but also to learn what actions were taken and the details of 
those actions.
    At this point, the hospital can continue to enter 
information about the product and the patient. And for your 
information, the patient's age, not the date of birth, is 
captured as a risk factor and will be useful in studying errors 
in pediatric and elderly populations. Various formats of output 
are available in the search area including spreadsheets, graphs 
and date export. A hospital can search its own data, other 
hospitals' data, or all data.
    The hospital selects certain search criteria, then 
generates the output. This example shows where in the 
medication use process the errors occurred and severity of 
those errors. To read the two records causing temporary harm, 
for example, which is category E that were committed at the 
prescribing phase, you would click to drill down on that area 
of the chart, then click again on the hyperlink to access the 
specific record. In conclusion, this presentation of the 
MedMARx program illustrates only part of USP's vision for a 
national data base.
    This year USP is partnering with Champion Hospitals to 
identify best practices and safer processes. USP believes that 
MedMARx can become a rich repository of experiences that can be 
of great value especially to regulators, manufacturers, 
educators and researchers. Congress can play an important role 
in strengthening voluntary reporting systems. Based on USP's 
experience, we believe that hospitals and providers would be 
more willing to supply information about medical errors if they 
are confident that their self-critical analysis will not be 
used against them in litigation.
    We strongly support the recommendation in Chapter 6 of the 
IOM report that Congress act to make such communications 
privileged and confidential. We understand that Congresswoman 
Connie Morella will soon introduce a bill to implement this 
recommendation and we urge support for her proposal. This 
change in Federal law will not shield incompetent practitioners 
from liability but will encourage the development of a robust 
reporting system that can prevent errors and enhance patient 
safety in the long run. USP looks forward to playing an active 
role in providing solutions to this national issue through its 
reporting programs. Thank you, Mr. Chairman, for this 
opportunity to address the committee, and I look forward to 
your questions.
    [The prepared statement of Diane D. Cousins follows:]
 Prepared Statement of Diane D. Cousins, Vice President, Practitioner 
               and Product Experience, U.S. Pharmacopeia
    The United States Pharmacopeia (USP) is pleased to have the 
opportunity to provide this statement to the House Commerce 
Subcommittees on Health and Environment and Oversight and 
Investigations and the Veterans' Affairs Subcommittee on Health. USP 
strongly supports Congressional consideration of actions it might take 
to ensure the significant reduction of preventable medical mistakes 
that occur throughout the continuum of the prescription, dispensing, 
administration, and use of medicines. USP further believes that 
development and implementation of federal legislation and regulatory 
policies, which will direct and guide public and private initiatives at 
the national, state, and local levels, must be achieved to ensure 
patient safety from medical mistakes, and to reduce substantively the 
multi-billion dollars that such mistakes currently cost the health care 
system each year.
    USP comments, offered for consideration, cover the following:

 Information about the U.S. Pharmacopeia's 30-year record of 
        stimulating voluntary health care practitioner reporting and 
        using the analysis of those reports to improving patient 
        safety.
 Background on USP's ability to affect change in drug product 
        labeling, packaging, and nomenclature when such are identified 
        as contributing to medication errors.
 An explanation of USP's new MedMARx' program--a 
        national, Internet-based, anonymous medication error reporting 
        system, introduced in July 1998, and now used by over 150 U.S 
        hospitals.
 A recommendation for Congressional action that can directly 
        and quickly remove one of the most significant barriers to 
        hospital and practitioner reporting of medication errors.
              usp's medication error reporting experience
Background
    USP, founded in 1820, is a volunteer-based, not-for-profit 
organization whose sole mission is to promote the public health by 
establishing and disseminating officially recognized standards of 
quality and authoritative information for the use of medicines and 
related articles for professionals, patients, and consumers. It is 
composed of approximately 500 members representing state associations 
and colleges of medicine and pharmacy, ten agencies of the federal 
government, and about 75 national professional, scientific and trade 
organizations, and members-at-large, including government agencies from 
other countries that recognize USP standards and non-U.S. 
pharmacopeias. The USP's expertise as a standards-setting body has been 
recognized by Congress in the enactment of the Drug Import Act of 1848, 
the Pure Food and Drug Act of 1906, the Federal Food Drug and Cosmetic 
Act in 1938, and by the Food and Drug Modernization Act in 1997, and 
others. Standards published in the official compendia, U.S. 
Pharmacopeia and National Formulary (USP-NF) are also referenced in 
most state pharmacy laws governing practice.
    USP began developing information relating to proper medicine use, 
in 1970, as support to its standards-setting activities. The USP DI, 
the compendia of USP drug information, is today recognized by the 
Federal Omnibus Budget Reconciliation Acts of 1990 and 1994 as a 
reimbursement resource for Medicaid Agencies considering issues 
associated with off-label uses of medicines and guidance for patient 
counseling. Based upon its federal recognition, and its reputation as a 
credible, authoritative, and non-biased source of information developed 
by approximately 800 volunteer experts, USP DI' also serves 
as a reimbursement resource for insurers and third party payers, and as 
the basis for drug formulary decisions.
    The process by which drug standards and information are developed 
is open, participative (notice and comment) and subject to integrity 
safeguards, including conflict of interest disclosure.
USP Practitioner and Product Experience Programs
    Because of our concern with the quality of drug products on the 
market, in 1971, the USP co-founded the Drug Product Problem Reporting 
Program--a national program in which health professionals were asked to 
voluntarily report problems and defects experienced with drug products 
on the market. Often the product problems or defects had to do with 
inadequate packaging or labeling--labeling that could lead to confusion 
on the part of health professionals or lead to errors; for example, 
look-alike color or design labels (color and design) and sound-alike 
drug names. Today, we continue to operate our Drug Product Problem 
Reporting, and a newer program, the Veterinary Practitioners Reporting 
Program, which collect voluntary reports on human and animal drug 
products.
    Eight years ago, in 1991, USP decided to focus more intensely on 
the problem of medication errors and what it could do to prevent them. 
Our focus today is on both the product and on the system in which the 
product is prescribed, dispensed, administered, and used. USP does not 
set practice standards per se, but practicably, many of our standards 
do indirectly affect professional practice and many practice standards 
are based on USP-NF standards.
    The USP learned that The Institute for Safe Medication Practices 
(ISMP) was seeking support of a national organization to bring its 
program, The Medication Errors Reporting (MER) Program, to the national 
level. USP agreed to coordinate the national program for ISMP. The
    MER Program is now one of four USP voluntary, spontaneous reporting 
programs for health care practitioners. The MER Program is operated 
under the umbrella of the USP Practitioner and Product Experience 
Division.
    Since late 1991, the MER Program has received more than 4,000 
voluntary reports of actual and potential medication errors. We also 
continue to receive medication error reports through USP's other 
reporting programs. These reports have identified errors in various 
health care delivery environments, including hospitals, nursing homes, 
physicians' office, pharmacies, emergency response vehicles, and home 
care. Through these reports, we have seen that errors are multi-
disciplinary and multi-factorial. They can be and are committed by 
experienced and inexperienced health professionals, support personnel, 
interns, students, and even patients and their caregivers. Medication 
errors can and regularly do occur anywhere along the continuum from 
prescribing to transcribing to dispensing and administration. The 
causes of errors may be attributed to human error, to product names or 
designs, and to the medication handling and delivery systems in which 
the products are used and individuals operate and interact. For 
purposes of voluntary reporting, USP does not seek to limit the types 
of errors that may be reported, because all information received may 
have some future value in determining how to reduce or prevent errors. 
We do not, however, actively solicit reports of adverse drug reactions, 
but USP cooperates with the Food and Drug Administration as a MedWatch 
partner and refer all reports submitted to USP.
    We recognize that an actual error may be reported as a potential 
error because of liability concerns, or a facility's risk management 
policies, so each report is treated with the utmost seriousness by USP, 
no matter how it is characterized by the reporter. As each MER report 
is received, it is shared with the product manufacturer and with the 
Food and Drug Administration. USP does not require, in the MER Program, 
that the name of the reporter, patient identity, or facility be 
provided. If provided, however, USP respects the desire of the reporter 
to keep his or her identity confidential and will purge the identity of 
the individuals or institutions named in the report in accordance with 
the instructions of the reporter. Reporters are advised of any actions 
resulting from their report either individually or through USP's 
Quality Review publication, which is disseminated to all persons who 
have reported to the MER Program and is publicly available on USP's web 
site.
                     usp's ability to affect change
    USP has 30 years of experience and demonstrated effectiveness in 
designing and operating voluntary reporting systems for health care 
professionals relating to drugs and their use, and using those data to 
improve product standards and safe drug use information.
Standards-Setting Authority
    Encouraging the reporting of errors is only one aspect of USP's 
efforts to promote safety of the medication use system. USP evaluates 
and implements, through its standards-setting authority, changes in 
drug products to prevent the recurrence of errors. The following 
examples describe some of the changes or other steps taken by USP in 
response to MER Program reports.

 Death reported due to the accidental misadministration of 
        concentrated Potassium Chloride Injection led to (1) changing 
        the official USP name to Potassium Chloride for Injection 
        Concentrate (emphasis added) to give more prominence to the 
        need to dilute the product prior to use; (2) labels must now 
        bear a boxed warning ``Concentrate: Must be Diluted Before 
        Use;'' and (3) the cap must be black in color (the use of black 
        caps is restricted to this drug product only), and (4) the cap 
        must be imprinted in a contrasting color with the words, ``Must 
        be Diluted.''
 Deaths reported due to the confusion and resultant injection 
        of the anticancer drug, Vincristine Sulfate for Injection, 
        directly into the spine instead of into the vein, resulted in 
        changes in the requirements for packaging by pharmacies and 
        manufacturers preparing ready-to-use doses. Each dose, whether 
        prepared by the manufacturer or the pharmacist, now must be 
        wrapped in a covering labeled ``FOR INTRAVENOUS USE ONLY'' and 
        that covering may not be removed until the moment of injection.
 Deaths reported due to the name similarity of Amrinone and 
        Amiodarone have lead USP and the United States Adopted Names 
        (USAN) Council to consider changing the official and 
        nonproprietary names of one, or both, products. (See attached 
        Quality Review: ``Proposed Drug Name Changes for Error 
        Protection.'')
 Deaths reported due to the inadvertent mix-up of neuromuscular 
        blocking agents (which paralyze the respiratory system) with 
        other drugs, have led to recommended changes in standards for 
        labeling and packaging of the therapeutic class of neuro-
        muscular blocking agent products.
 Medication Error Reporting reports of deaths identified the 
        need to establish dosing limitations for the sedative-hypnotic 
        Chloral Hydrate for use in children, and for the anti-gout drug 
        Colchicine. These dosing limitations have been incorporated 
        into the USP DI information in a special section in each drug 
        monograph to caution health professionals on each drug's proper 
        use based upon reports of errors received through the program.
    (See attached examples of Quality Reviews that describe other 
medication errors identified through the MER Program and for which USP 
has identified and communicated to health care professionals 
information and prevention strategies: ``Three is a Crowd;'' ``Insulin 
Oversight'' and ``Vincristine Sulfate Monographs Revised--Dispensing 
Pharmacy Practice Affected.'')
    Throughout its 180-year history, USP has focused on improving the 
quality of our medicines and their appropriate use. All of USP's 
programs focus on these goals. The standards in the official compendia, 
the USP-NF, define the identity, strength, purity, quality, packaging 
and labeling of drugs and their dosage forms. The USP is a member, with 
the American Medical Association, American Pharmaceutical Association, 
and the Food and Drug Administration of the United States Adopted Names 
Council (USAN) and publishes USAN names in the USP Dictionary of Drug 
USAN and International Drug Names, which is an international resource 
for pharmaceutical manufacturers, regulators, and health care 
practitioners. As noted elsewhere in this testimony, USP has taken 
actions, independently and in concert with USAN, to change the names of 
drugs and dosage forms when they have resulted in medication errors.
    Reported medication errors also have brought about other changes in 
USP standards and guidance to practitioners. For example, (1) USP 
discontinued recognition in the USP-NF of the apothecary system, a 
centuries old system of measuring weights and measures, in favor of the 
metric system in order to avoid misinterpretations that led to 
overdoses; (2) USP has made changes in general label requirements for 
marketed drug products, strengths less than one unit must be expressed 
as a decimal preceded by a zero (e.g. 0.1 grams, not .1 grams) to avoid 
ten-fold overdoses; and (3) USP standards also require that the 
strength of a product when expressed as a whole number be shown without 
a zero trailing the decimal to avoid ten-fold overdoses by the lack of 
recognition of the decimal point (e.g. 1mg, not 1.0 mg).
Collaborative Relationships: Food and Drug Administration; National 
        Association of Boards of Pharmacy; Colleges of Pharmacy
    Prior to the formation of the Food and Drug Administration (FDA) 
Office of Post Marketing Drug Risk Assessment, the Agency developed a 
formal mechanism for receiving and evaluating MER reports--the 
Subcommittee on Medication Errors. USP and FDA also created a joint 
advisory panel on the Simplification and Improvement of Injection 
Labeling to reduce medication errors. The Food and Drug Modernization 
Act of 1997 recognizes product labeling recommendations of that joint 
initiative.
    In 1991, to expand the scope of the MER Program, USP developed a 
joint program with the National Association of Boards of Pharmacy. The 
Boards of Pharmacy database is maintained by USP and assists each Board 
of Pharmacy to determine the relative extent of errors in its state and 
contributes to the overall incident collection effort.
    In addition to using the MER program to stimulate changes in 
enforceable standards and information, USP has used the MER information 
to develop educational tools for the health professions. In 1993, a 
curricular resource entitled--Understanding and Preventing Medication 
Errors--was distributed at no charge of colleges of pharmacy throughout 
the U.S. USP also has attempted to reach the public directly to teach 
patients how to protect themselves from medication errors through the 
development of a public service campaign--Just Ask . . . About 
Preventing Medication Errors.
National Coordinating Council for Medication Error Reporting and 
        Prevention
    USP has worked diligently during the past eight years, particularly 
in the standards-setting area, to build coalitions among health care 
organizations and to provide health care expert review of medication 
errors. In 1995 USP spearheaded formation of the National Coordinating 
Council for Medication Error Reporting and Prevention (NCC MERP). USP 
is the founding organization and continues to serve as NCC MERP 
Secretariat. To date, NCC MERP, comprises of 17 national organizations 
and federal agencies that share a common mission to promote the 
reporting, understanding and prevention of medication errors. Member 
organizations include practice organizations of medicine, nursing, and 
pharmacy, the licensing board of pharmacy and nursing, organizations of 
the pharmaceutical industry, the Department of Veterans Affairs, the 
Joint Commission, regulators, the FDA, the Joint Commission on the 
Accreditation of Healthcare Organizations (JCAHO), the American 
Hospital Association, and USP. In the years since its inception, the 
Council has produced internationally recognized work products, such as:

 a standardized definition of ``medication error.'' [See 
        Quality Review: National Council Focuses on Coordinating Error 
        Reduction Efforts]
 a categorization index to classify medication errors by the 
        severity of the outcome to the patient
 a taxonomy of medication errors
 recommendations to reduce the error prone aspects of 
        prescription writing; product labeling and packaging; and broad 
        recommendations related to the dispensing and administration 
        phases of the medication use process.
The Council is now re-examining how the standardized definitions noted 
above and in the attached Quality Review: ``Use Caution--Avoid 
Confusion'' can be honed, based upon experience gained from the MER and 
MedMARx (see below) Programs to provide clearer differentiation between 
categories. In addition the Council is examining issues of process 
failures in the use of verbal orders, benchmarking and inter-
organizational comparisons, and error rates.
Ad hoc Advisory Panel on Medication Errors
    In 1996 USP appointed an Advisory Panel on Medication Errors, an 
interdisciplinary group of health care practitioners who: review 
reports submitted to the USP Medication Errors Reporting Program; make 
recommendations for USP standards-setting; and make recommendations and 
participate in the activity of the NCC MERP. Mr. Michael Cohen, ISMP 
President, served as the first chair of this Panel and continues to 
serve as a member.
    In 2000, USP will constitute a new expert committee on ``Safe 
Medication Use'' that will fulfill a broader scope of responsibilities 
of the Advisory Panel that it will replace. The new expert committee 
will review data and provide guidance for the development of best 
practice solutions that will result in the reduction and prevention of 
medication errors.
USP DI and Drug Information Expert Advisory Panels
    The USP DI database is recognized internationally as containing the 
most up-to-date and authoritative information on off-label uses, 
warnings, contraindications, etc. New USP programs that will enrich the 
USP DI database will focus on the special needs to standardize products 
and develop information for neonatal, pediatric, and geriatric patients 
and populations. A unique contribution of the pediatric effort, 
developed in conjunction with experts in pediatric medicine 
communications is the ``Ten Guiding Principles on the Use of Medicines 
by Children and Adolescents.'' These principles have been distributed 
broadly and are being used in educational materials by pharmaceutical 
manufacturers and volunteer organizations. [See Guiding Principles 
Ruler enclosed.]
                         usp's medmarx program
    In early 1998, USP developed a nationwide program for hospitals to 
report medication errors. Hospitals were eager to submit reports to USP 
if reporting could be done anonymously and in a standardized format 
that would allow hospitals to track trends, and compare their data to 
other participating hospitals. USP's goal was to develop a model for 
hospitals first, ensure success of the model, then broaden the model to 
include other health care settings, e.g. long-term and ambulatory care 
settings, and other types of reporting such as medical error and 
adverse drug reactions.
    On July 27, 1998, USP made MedMARx TM available to 
hospitals nationwide. MedMARx is an internet-accessible, anonymous 
reporting program that enables hospitals to voluntarily report, track 
and trend data incorporating nationally standardized data elements 
(i.e., definitions and taxonomy) of the USP Medication Errors Reporting 
Program, the National Coordinating Council for Medication Error 
Reporting and Prevention (NCC MERP), and the American Society of 
Health-System Pharmacists. MedMARx is structured to support an 
interdisciplinary systems-approach to medication error reduction and 
fosters a non-punitive environment for reporting.
    Hospitals are encouraged to use MedMARx as part of the 
organization's internal quality improvement process, thereby extending 
their ``peer-review'' group to the group of hospitals in the program. 
Hospitals review the errors entered by other institutions in ``real 
time'' and also can view any reported action taken by another 
institution in response to an error or to avoid future similar errors. 
This feature affords institutions the opportunity to examine errors in 
a proactive manner. For example, the institution can review the error 
profile of a drug or class of drugs before a product is added to the 
institution's formulary to determine if certain risk prevention 
measures or training programs should be instituted prior to the drug's 
availability within the institution. Or, if the error profile is 
significantly serious, a determination to not stock the drug can be 
made. MedMARx also supports the performance improvement standards of 
the Joint Commission on the Accreditation of Healthcare Organizations 
(JCAHO), which requires institutions to look outward at the experiences 
of others in order to reduce risk.
    Currently over 150 hospitals have enrolled in the MedMARx program 
and other progressive hospitals and health systems are joining rapidly. 
Profiles of the participants show that hospitals of various types and 
sizes spanning fewer than 50 beds to approximately 1000 beds are 
enrolled. MedMARx hospitals include institutions of the Department of 
Veterans Affairs and the Department of Defense, and state-owned 
facilities.
    The USP commitment to MedMARx is broader than merely collecting 
data. In the coming year, USP will enroll champion hospitals 
participating in MedMARx in a long-term project to propose indicators 
of quality in the medication use process and to identify best practice 
standards and best process standards for the medication-use system.
               a recommendation for congressional action
    USP is heartened by the national attention resulting from release 
of the Institute of Medicine Report--``To Err is Human--Building a 
Safer Health System.'' USP is particularly gratified at the immediate 
action being taken by the House Commerce Committee's Subcommittees on 
Health and Environment and Oversight and Investigations and the House 
Committee on Veterans' Affairs Subcommittee on Health. We are pleased 
to offer the following specific recommendations:
 Focus Attention on the Quality of Health Care System
    As the first step in preventing medication errors, the priority 
should be on fixing the system, not the blame. The IOM report is clear 
that mandatory programs at state and federal levels have not 
effectively captured the full number of errors occurring. The report 
argues that the public needs some assurance of a minimum level of 
protection (i.e., through reporting, investigations and follow-up) and 
that health care organizations need to be ``incentivized'' to improve 
patient safety. In fact, mandatory reporting could provide a false 
sense of protection if the mandatory programs are no more effective 
than those already in existence. Therefore, perhaps the question at 
this time should be: ``What needs to be done to improve the quality of 
healthcare systems that will provide these assurances and incentives?'' 
Numbers and statistics from such mandatory programs may not be as 
useful to the public and, in fact, may erode the confidence of the 
public if shear numbers are used as a gauge of quality. What confidence 
can a citizen have in the health care system when the error profiles 
for both (or maybe the only) rural hospital(s) in their area show that 
harmful errors have occurred there? ``To Err Is Human'' leads us to 
believe that no hospital is likely to be error free. The fact that a 
harmful error has not yet occurred in a facility is no assurance that 
it will not occur, or that it has, in fact, occurred but has not been 
recognized as such or reported. To better serve the public, it would be 
far more useful to have the knowledge and assurance that the hospital 
has adopted safer processes and best practices when errors have 
occurred in order to reduce the possibility of errors. We believe a 
system that provides a public indicator that these best practices are 
adopted, in effect a facility's ``report card,'' would be a more 
effective tool for consumers to help choose the best and safest health 
care facilities for themselves and their families.
    A national voluntary reporting system ensuring confidentiality in 
support of the above framework should help accomplish this by reporting 
and documenting actions taken in response to an error. A more robust 
database will also provide opportunities for risk prevention and 
designing error out of medication use processes. As an incentive to 
report, information submitted to the system should be treated as 
privileged per federal statute as is currently the case in states that 
provide for peer-review protection. What should be mandated for 
hospitals and other healthcare facilities is not reporting, per se, but 
the development of quality control systems (of which reporting is a 
part) that implement these best practices and improvements to prevent 
and correct system weaknesses. For example, the federal government can 
create a public report card using the inspection and survey processes 
of state boards of pharmacy, HCFA, and JCAHO. Incentives for facilities 
can be provided by third party payers and insurers that require the 
adoption of such standards and practices into every healthcare system 
as a contingency of reimbursement under Medicare and Medicaid programs.
    Finally, under all circumstances, every victim and/or the family 
should have the legal right to be told by the health care professional 
or facility if an error has been committed in the deliverance of their 
care that has resulted in harm to the patient, increased 
hospitalization, or medical or therapeutic intervention.
 Protect the Confidentiality of Data Submitted to National 
        Voluntary Reporting Programs
    Among the IOM Report's discussions and recommendations is 
recognition that the absence of federal or state protection from 
disclosure of medication error reported information poses a major 
barrier to voluntary reporting of errors, or potential errors. Health 
care practitioners are concerned about reprisals and practitioners and 
health care institutions and delivery systems are concerned about 
liability. USP believes, therefore, that Congress can make a 
significant contribution to the development and successful 
implementations of systems that facilitate voluntary medication error 
reporting and tracking through immediate consideration of legislation 
that would protect information developed in connection with error 
reporting by hospitals and other institutions and health care settings. 
USP currently is developing such legislative language for House and 
Senate consideration.
                               conclusion
    In closing, I wish to assure Committee and Subcommittee members 
that USP shares with Congress the goal of a safe medication use system. 
USP has made a public and long-term commitment to working proactively 
with all stakeholders toward that goal. We particularly look forward to 
working with Congressional leadership on the issue of fostering 
effective systems that support best practices, accountability, and 
confidentiality to stimulate greater reporting, analysis, and system 
changes to prevent medication and medical errors and to ensure 
confidence in our health care delivery system.

    Mr. Bilirakis. I thank the panelists. I will start out with 
the first series of questions. Dr. Cousins, I was just 
intrigued when you were talking about the report card. I was 
wondering if you would elaborate on that. Would other members 
of the panel also like to comment, perhaps, on your report 
card. Go ahead.
    Ms. Cousins. The report card is mentioned in our written 
testimony. Essentially in the debate of mandatory versus 
voluntary as posed in the IOM report, it is clear that the 
mandatory systems to date have not yet been effective. In fact, 
having such a system that is modeled the way previous systems 
have been modeled could in fact give a false sense of 
protection to the public. Perhaps we would reframe that 
question and ask what would be done to assure the public that 
systems are safe. To that end, I would imagine that the public 
data base posed in IOM might, for example, serve me as a 
patient if I were to look at what hospitals in my area might 
have errors and look at their safety profile.
    I might find, in fact, that the only two hospitals to my 
region both show that there have been errors at the facilities. 
So what assurance does that really give me that the quality of 
care that I had at either of those institutions of my choice 
might meet my standard. I might also say that if I see no 
reports for those hospitals, what would that tell me? Well, it 
doesn't really tell me much. Does that give me any assurance 
that that wouldn't happen to me, that there wouldn't be a 
serious or fatal error when I am admitted.
    We feel that in order to get to the issue of safer systems, 
we need to provide some kind of way for patients to be able to 
analyze information in a more understandable way and so the 
concept of a report card would provide oversight by those that 
are responsible for various settings like National Association 
of Boards of Pharmacy for retail pharmacies or perhaps the 
Joint Commission for Hospitals whereby their survey results are 
public but specific in areas for medication error prevention 
and the adoption of the lessons that we have learned to help 
prevent those errors in the future.
    Mr. Bilirakis. Anyone else on the panel that would like to 
comment on that? Dr. Garthwaite.
    Mr. Garthwaite. I think I would largely concur with that. I 
think the public would be most interested in and would be most 
helped if systems adhere to certain principles. Do they adhere 
to telling patients if they commit error, do they communicate 
that to the patient, do they have a system to report their 
experience so that the fewest number of people have to be 
injured in order to learn lessons? Have they implemented all 
applicable safety standards including those related to adverse 
drug events, and do they have in place an effective safety 
program?
    I think if your health care system has all those in place 
you would have some reasonable assurance that they are making 
progress at identifying error, putting in place standards of 
safety, and they may have other measures of quality that might 
also be helpful on a report card.
    Mr. Bilirakis. Dr. Bagian, as a former F-15 pilot, an 
astronaut, and an expert in the whole area of computer 
simulation, I would be curious if you think that computers 
could use simulation to help bring medical errors down.
    Mr. Bagian. Well, yes, sir. Just one correction. I wasn't 
an F-15 pilot.
    Mr. Bilirakis. Okay.
    Mr. Bagian. Yes. We think simulators have huge value. The 
reason for simulation in aviation as it is in medicine are 
basically three fold. You simulate in areas where the events 
either happen too infrequently to provide an adequate training 
opportunity, where the event is too hazardous, certainly in 
patient care that would fit as it does in aviation, and the 
other is the cost involved to do that. Medicine qualifies in 
those areas.
    At the Palo Alto VA, in fact, we have a simulation facility 
there where both training and research is done where we have an 
entire operating room setup that is indistinguishable from a 
real OR as far as the type of equipment used. It is real 
equipment. There is a mannequin there that has eyes, the pupils 
dilate, they expire gases, reflect the metabolic state of the 
patient so to speak so it actually changes the concentrations 
of carbon dioxide or oxygen accordingly, the anesthetic gas the 
same way. So it really acts in all ways as a human would under 
various situations.
    And then you can impose various problems, you know, 
illness, complications, a reaction to a medication, for 
example, various things such as that. And this enables you to 
not only train but to try to observe what are the most 
effective strategies to deal with certain normally uncommon but 
very severe situations. We think this is the way to really do a 
lot of your training in a high hazard area. For instance, with 
codes, cardiac arrest treatment, you can do this many times 
where people can learn without having real patient problems so 
we think there is tremendous utility to simulation. Absolutely.
    Mr. Bilirakis. Thank you. I would just conclude, Dr. 
Garthwaite, that I think when we looked at the President's 
budget for 2001 the staff and I were concerned there is no 
increases in the VA research funding. This would effectively 
shrink the research program. And I guess considering patient 
safety is a No. 1 topic, why hasn't the President increased 
funding in that area?
    Mr. Garthwaite. Well, we believe within the allocation we 
can prioritize funding in different areas and we are 
prioritizing health services research on patient safety. In 
addition, some of the studies are at the level of more 
administrative evaluations which I think we can fund out of 
medical care dollars to some degree.
    Mr. Bilirakis. Mr. Barrett for 5 minutes.
    Mr. Barrett. Thank you, Mr. Chairman. I appreciate you all 
being here. Dr. Garthwaite, nice to see you. Dr. Heinrich, I am 
not always really that excited about saying when I have made a 
mistake, and I don't know that I am that different from a lot 
of people in that if you make a mistake you would just as soon 
forget it and you probably are a little less likely to want to 
acknowledge it if you think it might have some ramifications on 
your career, so even if we have a good reporting system where 
individuals can voluntarily report their errors and they feel 
safe doing so, aren't there some real sort of human nature 
limitations that come--other types of limitations in relying on 
reporting systems?
    Ms. Heinrich. Certainly in our review of the spontaneous 
reporting systems, we found that there are a variety of issues 
that affect the ability of people to report and to wish to 
report. First of all, there is the issue of the complexity of 
medical care and the fact that it is very difficult to really 
attribute a particular result to a particular event. As we 
said, many of the adverse events are because of adverse 
reactions when medical care was appropriate.
    I also think that one of the issues that my colleagues here 
have brought up was related to definitions of those events. I 
think that there are many different definitions of what is 
being requested in terms of reporting systems and those vary 
from institution to institution. And then of course we have 
heard that fear is of great concern in terms of reporting. We 
did note that when we looked at the experiment, the pilot study 
that the FDA did when they were doing the medical devices when 
they did include confidentiality there was an increase in 
reporting, but there was also then the problem of having more 
difficulty in following up when the information wasn't complete 
so that they could take some kind of corrective action.
    Mr. Barrett. This issue is obviously a hot issue. The media 
has been paying a lot more attention to it and I think people 
are just generally more interested. And I guess I was under the 
impression that the data we are working with now is not coming 
primarily from self-reporting, it is coming more from 
scientific studies. And so I am wondering as you sort of look 
into the future, how important is it for us to continue the 
scientific studies or other than a self-reporting system what 
do you see as an effective mechanism to provide us with the 
data that we need?
    Ms. Heinrich. If we are really going to understand the 
magnitude of the problem, we do need those special studies and 
they are expensive. The very best data that we have as we said 
before, are from the statewide studies that were done, the one 
in New York and then the studies that were done more recently 
in Colorado and Utah. They are taking good random samples of 
patients who have been in a hospital over a period of time, and 
as I think was said from the previous panel those studies have 
very clear definitions and the interpretation of the medical 
records was done by experts. This kind of study is expensive 
but we clearly need to do more of them.
    Mr. Barrett. Dr. Garthwaite, what is your view on this?
    Mr. Garthwaite. I agree with Dr. Bagian's point that we 
need to find the errors and the weaknesses in the systems from 
whatever means possible. Scientific studies are very helpful in 
estimating the magnitude of the problem. Once you find 
vulnerability, the key is whether you can design a fix and 
implement it. We understood that the timing of administration 
of medications, the writing of the prescription or order for 
medication, the interpretation by a whole series of people 
along the line was prone to error.
    What we found was that one of our hospitals had designed 
their own system for bar coding that eliminated a lot of the 
human factors. With that knowledge what we needed was the 
courage to find the funds to implement that nationwide once we 
determined that that was going to prevent the bulk of 
medication administration errors in our healthcare system. So I 
think we learned that relatively readily. It didn't take a huge 
number of studies to find the problem. It is a commitment to 
redesign the system and fix it.
    Mr. Barrett. Well, you both have mentioned the need for 
investment and obviously we can collect data until the cows 
come home but if we don't have an investment in developing that 
data. What kind of an investment are you talking about here, 
Doctor?
    Mr. Garthwaite. Our plan for the year 2000 is to invest 
about $118 million out of our budget in safety-related 
activities. That covers the gamut and the largest amount of 
that is in training our employees to think about safety, to 
understand the reporting system, and the nature of errors, to 
think about close calls and to report them, and that means 
training 180,000 people essentially to change the way they do 
business.
    That is critical. It involves Jim Bagian's staff. It 
involves the Centers of Inquiry for Research. It involves some 
funding for some scholars in this area because we don't think 
that physicians have been trained adequately in general in the 
United States yet, and it involves the computer support for the 
reporting systems we put into place. So we have a fairly 
comprehensive plan that is expensive, but it is the right thing 
to do. In the long-term we will save because mistakes are 
expensive and paying for the extra care caused by the mistakes 
is expensive.
    Mr. Barrett. Thank you.
    Mr. Stearns [presiding]. The gentleman's time has expired. 
Mr. Smith from New Jersey.
    Mr. Smith. Thank you very much, Mr. Chairman. First of all, 
I want to thank and praise in the strongest possible terms the 
good work of the VA in being proactive. I just now read the 
handbook. I heard about it and now I see it and look at it in 
more detail and it seems to be a very comprehensive document. 
And obviously the proof will be in the implementation but I 
have every confidence that you will do it and do it well.
    I do have a question, Dr. Garthwaite, or perhaps Dr. 
Bagian, a question about once there is a near miss or some 
other problem that is discovered, what does the counseling 
actually look like in the VA hospital?
    Mr. Bagian. I will be happy to answer that, sir. What 
happens is when the report first comes in, and I will use the 
term risk manager, some places we call it a quality manager or 
process manager but the individual with whom those reports 
reside when they come in from numerous avenues. They then make 
a determination and the first thing that we make very clear is 
they make a determination ``is this an intentionally unsafe 
act,'' and we have paragraph 3.d. I think is where the 
definition is if I recall.
    And what you do is you say intentionally unsafe acts are 
just those that appear to be intentionally unsafe. That means 
we don't use the word reckless because that has certain legal 
meanings. We say if it appears that somebody did something that 
was unsafe in an intentional manner, that doesn't come in the 
safety system. That needs to be addressed another way. We say 
cases where the caregiver, the provider, was impaired due to 
alcohol or substance abuse that goes a different route. Alleged 
patient abuse, that goes a different route, and criminal 
activity goes a different route.
    As long as it doesn't fall into one of those four 
categories, and very, very few do, I might add, then it comes 
into the safety system. The safety system, then we do a very 
thorough root cause analysis, which it is a computer-aided tool 
that helps the individuals in a team, we impanel a team, they 
are told and actually by letter from the facility director that 
they are to serve on this team, what their capacity is. They 
then are charged to go out and to gather whatever information 
is necessary to understand what the root contributing causes 
are.
    Then they not only do that but come up with what the 
appropriate corrective actions are, the plan for implementation 
including funding or whatever else is necessary to make this 
happen. Then, and this all goes into a report, they will check 
to make sure it works. It is one thing to say here is a 
solution. It is another thing to prove that it in fact works. 
We think it will but until you prove it you really don't know.
    And then the critical phase we have is, the facility 
director has to sign and either concur with each individual 
corrective action or not concur, and they may not. And there 
are good reasons they may not but then they have to report 
their rationale why they didn't. It is not just ``because.'' 
They have to say, you know, what the real because is and then 
the group comes to some agreement as to what the alternative 
corrective action will be. And then they classify their 
corrective actions as to if it eliminates the problem, controls 
the problem or they accept the problem. They say, hey, we don't 
have a solution right now.
    And that way anything that is not eliminated and verified 
to be eliminated you can look at in the future and you will 
have a way to look at it to say was this the best control. 
Anesthesia was brought up earlier, by I forget which gentleman 
here. Anesthesia, had a big problem in the early 1980's. There 
was no pulse oximetry. Inadvertent disconnect from the 
breathing circuit was one of the primary causes of 
complications and once pulse oximetry existed, which was in the 
mid-'80's, that suddenly went way down.
    So you have a good technique in the 1980's and you are 
telling everybody to be careful. I was an anesthesiology 
resident then. I can tell you, be very careful you are 
cautioned. Nobody goes in to hurt a patient but it happens. 
When they came up with a mechanism that also helped you it went 
way down so it was a system solution. So we put that all 
embedded in there so there is a system that rolls up. We can 
look at it, we can help them with that, and we think that makes 
a more robust system. Does that kind of answer it?
    Mr. Smith. Very well, and hopefully the VA will be able to 
provide at least a path for others to follow because you are 
obviously the most integrated network of healthcare in the 
country. I have a question for Dr. Heinrich. Your comments 
obviously seem to--are adverse to the IIO's comments with 
regards to the 44,000 to 98,000. In that you point out that 
there is just a little evidence available out there.
    It is my understanding that the New York study, there were 
71 deaths, and I could be wrong on that but that is my 
understanding and then that was extrapolated out to 98,000. I 
mean what kind of science are we dealing with here in terms of 
methodology from your point of view? Again, some of those 
studies are old as I pointed out earlier but the New York death 
rate or the deaths attributable to the hospitals, the care, 71. 
What is your feeling on that?
    Ms. Heinrich. Well, as you have noted, we did express some 
concern about the extrapolation of studies in these three 
States to the rest of the country. We have pretty good 
information about the variability in medical care across our 
country so I think there is some concern in making an 
extrapolation like that.
    Mr. Smith. The problem is, if I could take one final 
second, most of the press have left. We don't want hyperbole. 
We want good patient safety based on good science. The VA 
certainly is being proactive and I think we are all very proud 
of that fact that they are doing that but we don't want to have 
misinformation out there so that it has the unwitting 
consequence of people saying I am not going to the hospital 
because I don't want to get sick or die when that is not the 
case. We want good honest figures and I think that study may 
unwittingly again do a disservice by not being more reliable.
    Mr. Stearns. The gentleman's time has expired. Mr. 
Strickland, recognized for 5 minutes.
    Mr. Strickland. Thank you, sir. I have two questions, one 
for Ms. Cousins and one for Dr. Heinrich. The first question, 
Ms. Cousins, USP is proposing legislation that would allow 
hospitals to report information to MedMARx without waiving peer 
review privilege granting confidentiality information. This 
would insure that hospitals are protected from having 
information disclosed but the question I have is granting these 
protections to an institution won't address all the problems 
associated with individuals who may choose to report because 
they are afraid, because they don't want to be embarrassed 
because the supervisor may find out, because they may lose 
their job, not get a promotion, a variety of reasons.
    And my question is do you believe that protections for 
individuals who do reporting are something that we need to be 
concerned about and discuss, and if so what kind of steps can 
be taken to assure that practitioners are given the kind of 
assurance that they need that would encourage them to come 
forward?
    Ms. Cousins. I believe what we are proposing would cover 
all healthcare sites, not just hospitals, and also would cover 
the individuals involved so it would be any information that is 
created in support of a medication error event submitted to 
national reporting programs, not just actually MedMARx but all 
of those programs that we would operate so we are looking at 
the broader picture.
    I believe that what needs to happen to give confidence to 
those involved in the healthcare system is really an overall 
review of their internal processes to establish these systems. 
We find that the first thing that happens when they bring 
MedMARx into an institution is that they need to separate 
sometimes for the first time the performance of individuals 
from the ability to capture information on errors so that first 
step within a facility gives the individuals confidence that 
there won't be reprisal regarding their positions.
    And then we talk often times with hospitals that say, well, 
how do I go about separating and how do I pursue those 
disciplinary problems or those performance problems so that is 
something we work out with each hospital based on what they 
might be doing internally but really that is the first step is 
to make that division and then that I think demonstrates the 
commitment of the administration to that kind of a system and 
then the system is built around identifying the errors 
separately.
    Mr. Strickland. Reporting could be done by individuals who 
are directly involved in the error.
    Ms. Cousins. Yes.
    Mr. Strickland. And I assume reporting is also done by 
individuals who may not have been involved in the error but who 
have observed that, people we have referred to as 
whistleblowers. What kind of protections would you envision 
that would be necessary for individuals who may not be directly 
involved in the particular error but who have observed that and 
feel that it should be reported?
    Ms. Cousins. Again, I think the protections for the 
information as we are proposing but we do in fact have cases 
where other individuals who either observed the event or were 
involved in the event tangentially do share reported 
information with us and openly so I think it is really the 
information that we are looking to protect.
    Mr. Strickland. I would just make the point that in the 
patient's Bill of Rights, which was recently passed by the 
House individuals who would choose to come forth and report 
incidents would enjoy protections from retaliation for having 
done so. Dr. Heinrich, if we are really going to learn from our 
mistakes, and we certainly want to, it seems to me that we are 
going to need to have the ability to collect a lot of 
information about what went wrong and why it went wrong, i.e., 
inadequate staffing, for example. I hear a lot of information 
from nurses saying that they are being stretched too thin and 
their responsibilities are being given to people with lesser 
training and so on and so forth.
    How important is it to have the ability to follow up to 
gather follow-up information regarding these error reports and 
do we see a problem in our ability to gather follow-up data in 
existing systems and what limitations on gathering follow up 
information would be the result of having anonymous or 
confidential reporting systems?
    Ms. Heinrich. I think your question hits a very critical 
point and that is that the surveillance systems in and of 
themselves aren't so helpful. It is your ability to go back and 
really understand the cause, the circumstances, or the systems 
and how they operate that impact on adverse events. I think it 
is interesting that now, certainly in hospitals and other 
healthcare environments, it is required that we have records of 
adverse events. And again we know that they are probably under 
reported by a significant amount.
    What I question or what we question is the kind of really 
proactive analysis of that information that there is either at 
the institutional level or at the State level or at the 
national level.
    Mr. Stearns. The gentleman's time has expired. The chairman 
of the Health Subcommittee, Mr. Bilirakis.
    Mr. Bilirakis. Thank you, Mr. Chairman. Doctor, first I 
want to welcome the panel and to thank them for taking the time 
to be here. Of course thanks to Dr. Nelson particularly for 
leaving that much better weather down there in our Tampa Bay 
area to come up here. Welcome. Dr. Heinrich, you have 
questioned, the extrapolation from three States, etc. Does GAO 
have any opinion as to a better answer in terms of the numbers? 
Or did you just merely review what was done and then give us 
your opinion regarding it, but not go any further than that?
    Ms. Heinrich. That is absolutely correct. The studies that 
we are referring to are the studies that give us the very best 
information on the magnitude of the problem. And as others have 
said, we know even less about what is going on in ambulatory 
care and nursing homes, for example.
    Mr. Bilirakis. Some time ago I think we requested some sort 
of a GAO study. Well, anyhow the point is that there is no 
better information available that you know of.
    Ms. Heinrich. That is correct.
    Mr. Bilirakis. Dr. Nelson, just again very quickly, I 
wonder how well the VA's revised patient safety handbook has 
been received by the staff in Florida's VISN network. In other 
words, have the VA employees accepted it and are they using it? 
Do you have an opinion about that?
    Ms. Nelson. Yes. We are the first pilot site for the 
patient safety handbook and I participated in the training 
sessions for the quality managers and risk managers and they 
were very enthusiastic about the potential. I guess they 
started in the fall so, yeah, they are just getting into it 
right now but the response has been very favorable.
    Mr. Bilirakis. Great, good to hear that. Well, again, very 
fundamentally to Dr. Garthwaite and Dr. Bagian, as the VA 
healthcare system has evolved away from an inpatient hospital 
system, and we know that it has, the VA has increased the 
amount of care provided to veterans through contracts with 
other healthcare providers. So I guess my question is are these 
providers required to tell veterans when they have made an 
error, are they required to report errors to the VA even though 
they are contract and not really directly employed by the VA?
    Mr. Garthwaite. That is a good question. I need to find out 
the answer to that for you. I will get back to you. I can't 
answer with certainty. I should be able to.
    Mr. Bilirakis. Do you know if the medical inspector's 
report on the VA patient safety event registry includes 
information from these contract healthcare providers?
    Mr. Garthwaite. It wouldn't, I don't believe. It was done a 
couple years ago and it was really a report of our internal 
rollup of events.
    Mr. Bilirakis. So there may be a gap there that should be 
looked at.
    Mr. Garthwaite. I appreciate that. I will look into that.
    [The following was received for the record:]

    The VA's patient Safety Event Registry did not include 
separate identifiers for contract healthcare facilities in FY 
1997 and 1998. The three identifiers used were: patient, 
outpatient and long-term care. In a few instances contract 
nursing homes were identified. VHA's new system will be capable 
of identifying care location.

    Mr. Bilirakis. Well, thank you. The annals of internal 
medicine suggest that hospitals can forestall expensive 
litigation by admitting mistakes and offering fair compensation 
before the patient or the patient's family even realizes the 
error. The VA Medical Center in Lexington has a policy that 
calls for full disclosure to patients injured either 
accidentally or through medical negligence. I believe that the 
results seem to be good in that regard, right? Has the VA 
implemented this policy nationwide and if not why hasn't it?
    Mr. Garthwaite. Yes. That is current VA policy. Lexington 
carries out this policy but they more proactively set up who 
does that and took additional steps to assure that there was 
some consistency to how that was done with their district 
counsel and with the specific members of their medical staff so 
I think we have learned from that.
    That report came out I think in either December or January, 
late December. Although we made the rest of our networks and 
the other providers aware of that, we haven't had an 
opportunity to review what the advantage is system wide of 
implementing their process.
    Mr. Bilirakis. So you haven't contemplated whether you 
might mandate that throughout the entire system?
    Mr. Garthwaite. We have already mandated that everyone is 
informed and so what we need to understand is what are the 
nuances of the way they have done it that help. Very clearly if 
you feel fairly treated as a patient, if people admit they have 
made a mistake and help provide you remedies for that mistake 
your need----
    Mr. Bilirakis. Good bedside manner, so to speak. I know 
that is what I have seen over the years. Frankly, doctors with 
a fine bedside manner that show caring are sued less than 
others. I know my time has expired and maybe we won't go into 
any response to this but I am concerned what kind of factors do 
you look at when you conduct a root cause analysis?
    Do we look at factors like--and other areas have been 
mentioned--number of hours or shifts an employee worked prior 
to the event, etc.? I don't really want to take up too much 
time. If you have a quick response and the chairman will allow 
it.
    Mr. Bagian. If I may, I can give a quick response. Yes. In 
fact, we can show you another time if you like, we have a whole 
human factors module that goes in here where we ask some 
prompting questions, was fatigue a problem, was scheduling a 
problem, was equipment, things like that, and then it gives 
them a whole host of questions that get right into that exactly 
so it is not left for their memory. It is a human factors tool. 
It steps them through a number of questions so that we do very 
specifically delve into just those things, sir. Yes.
    Mr. Bilirakis. Thank you. Thank you, Mr. Chairman.
    Mr. Stearns. The gentleman's time has expired. Dr. Snyder 
is recognized for 5 minutes.
    Mr. Snyder. Thank you, Mr. Chairman. I am sorry I was late 
getting here. The Armed Services Committee was meeting with 
Secretary Cohen and General Sheldon this morning. But in 
deference to you in my time to ask questions of Secretary 
Cohen, I did bring up the issue of medical errors since they 
also have a closed system and have opportunities, I am sure, 
for improving things. I will make one comment. In the Armed 
Services Committee room, we don't let the smell of food in the 
room during the noon hour.
    I don't know what it is here but we got the distinct 
impression we are being tempted. You know, some time in my past 
I went through a phase over a few months of asking people 
involved in the business what was the worse mistake they ever 
made. You know, these are friends. I remember talking to a 
nurse one time and her first job had been as a nurse's aide in 
a nursing home before, you know, literally hiring people off 
the street and teaching them how to administer meds.
    And she gave a dose of morphine 1 day and a short time 
later the patient was dead. And it was only years later when 
she was in nursing school learning how to administer drugs 
doses did she realize she had missed a decimal point and almost 
for sure killed that patient. My favorite one was an emergency 
room that had an active resuscitation going on and they were 
administering oxygen. I think it was some kind of humidifying 
agent.
    And they realized later after the patient had expired that 
they had instead of using like normal saline or something had 
grabbed the preservation fluid for pathology samples. But the 
best part of it was when it was called to the staff's attention 
in the emergency room, they said, you know, that happened last 
week too because the bottles were right next to each other, 
very similar, and in the course of a code you just grab that 
same bottle. But somewhere is two very well-preserved sets of 
lungs that didn't survive.
    I remember talking to a young man one time in his residency 
that worked as a military doctor and he said to me one time, he 
said, you know, I know I have killed people, he said, but it 
was always in the context of trying very, very hard to do the 
right thing. I think that is what everybody is about it how do 
you help people who try very, very hard not to do the wrong 
thing. So it seems like this report that came out is a real 
opportunity for our country and for healthcare facilities and 
healthcare providers and for patients to do the right thing.
    I have some fear we may get all bogged down in our politics 
and, you know, all the different advocacies that can come to 
bear on this problem in general but that is just the nature of 
the system. One specific question I wanted to ask, and I 
apologize if this has been discussed earlier, but I come from a 
State that has both rural and metropolitan areas. We have a 
fair number of hospitals of varying sizes. If I am a hospital 
administrator out there and I have read this book and I think, 
gee, every hospital thinks we are doing--we are safety 
conscious, we are doing the right thing, this report seems to 
indicate that perhaps we are not doing anywhere near what we 
ought to do.
    What should I do as a hospital administrator or a doctor 
working in a hospital or medical facility, what should I do 
starting today? What recommendations do you have for people out 
there who want to do the right thing?
    Ms. Cousins. Two things I would recommend. I think the 
first thing, everyone would probably agree, would be the 
culture change. There needs to be support from the top, from 
the administration, that it is safe to share your experiences 
and to share them outright. The second thing is that I think we 
have learned so much from our medication errors reporting 
program and through the good work of the Institute of Safe 
Medication Practices, there has been so much education done and 
yet the lessons we have learned have not been adopted.
    So if I was in the administration I would seek out those 
things that have been put out to the public as recommendations 
or guidelines or guidances or general information about the 
kinds of errors we are seeing and insure that my facility is 
adopting the things that make good sense for us.
    Mr. Garthwaite. I would totally agree with that. I think 
that as an administrator you have to realize that your job is 
not to hire perfect human beings and hope you can catch them 
making a mistake. Your job is to hire human beings and 
recognize they are going to make mistakes and understand it is 
your job to try to help design systems to support them in doing 
their job that minimizes the chance of making a mistake and 
that minimizes the consequences if a mistake is made.
    And so you should go back and say Formalin and normal 
saline have to be in different colored bottles and they must 
not be stored next to each other because that would be 
confusing. What we did was find that concentrated potassium 
chloride because of the potential for error in mixing and 
calculating the dose shouldn't be done sporadically, it should 
be done by someone who does it all the time so it should be in 
the pharmacy, never on the wards, and we removed it all from 
the wards. We also found that bar codes prevent you from making 
mistakes such as confusing which patient gets the medication, 
what dose of the medication is given, and the time of the 
administration of medication.
    It is all those system things that are really at the root 
of all this. It is critical for an administrator to recognize 
that, say that, and when someone is willing to come forward and 
say there is something broken in the system, reward them for 
it, don't punish them. Thank you.
    Mr. Snyder. Thank you. Thank you, Mr. Chairman.
    Mr. Bilirakis. I thank the gentleman. If there aren't any 
further questions with this panel, we will release you again 
with our thanks. You have been of immense help. The last and 
third panel, the third and last panel, Mr. Daniel Perry, 
Executive Director of the Alliance for Aging Research on behalf 
of the Foundation for Accountability, Dr. Dennis S. O'Leary, 
President of the Joint Commission on Accreditation of 
Healthcare Organizations, Dr. William Golden, President of the 
American Health Quality Association, Dr. Michael L. Langberg, 
Senior Vice President, Medical Affairs, Chief Medical Officer, 
Cedars-Sinai Health System on behalf of the American Hospital 
Association, and last and not least, Ms. Mary Foley, RN, 
President of the American Nurses Association.
    Well, as you have heard, your written statements are a part 
of the record. We will set the clock at 5 minutes. I would 
appreciate it if you would stay as close to it as you possibly 
can and obviously hopefully you will be complimenting and 
supplementing your written testimony. And we will kick it off 
with Dr. Perry.

 STATEMENTS OF DANIEL PERRY, EXECUTIVE DIRECTOR, ALLIANCE FOR 
  AGING RESEARCH, ON BEHALF OF FOUNDATION FOR ACCOUNTABILITY; 
DENNIS S. O'LEARY, PRESIDENT, JOINT COMMISSION ON ACCREDITATION 
  OF HEALTHCARE ORGANIZATIONS; WILLIAM E. GOLDEN, PRESIDENT, 
   AMERICAN HEALTH QUALITY ASSOCIATION; MICHAEL L. LANGBERG, 
SENIOR VICE PRESIDENT, MEDICAL AFFAIRS, CHIEF MEDICAL OFFICER, 
  CEDARS-SINAI HEALTH SYSTEM, ON BEHALF OF AMERICAN HOSPITAL 
    ASSOCIATION; AND MARY FOLEY, PRESIDENT, AMERICAN NURSES 
                          ASSOCIATION

    Mr. Perry. Thank you, Mr. Chairman. I will summarize my 
written statement. My name is Dan Perry, and I serve as 
Chairman of the Board of Trustees for the Foundation for 
Accountability, commonly known as FACCT. FACCT is a 4-year-old 
not-for-profit organization dedicated to helping Americans have 
reliable information they can use to help make better health 
decisions. FACCT was created by and continues to be governed by 
large healthcare purchasers and consumer organizations.
    In my professional life, as you have stated, I also serve 
as Executive Director of the Alliance for Aging Research here 
in Washington. Safe health is the first concern of every 
patient and it must be recognized also as a vital public 
interest. We applaud the work of the Institute of Medicine and 
the interested congressional panels in raising public awareness 
about the unacceptably high rates of medical errors in our 
health system. And we are pleased that so many healthcare 
leaders have come forward to acknowledge the seriousness of the 
issue and the need for corrective action.
    However, we are not confident that the health professions 
and the leading healthcare institutions are capable of 
correcting these problems without external pressure, pressure 
that could be provided by individual patients and by the 
public's collective expectations of better healthcare. Wherever 
we have looked at health plans, medical groups, integrated 
health systems we find inconsistent and inadequate care being 
delivered to too many people. We also find a general 
unwillingness to share quality information with the public and 
a discomfort with the basic premises of public accountability 
which is that health professionals and organizations must 
disclose how they are doing.
    Our research and others confirms that safe medical care is 
a central concern of most Americans. A survey by the American 
Society of Health System Pharmacists revealed that 61 percent 
were very concerned about being given the wrong medication in a 
hospital. The AMA has found that 42 percent of Americans 
believe that they or a family member or a friend has been the 
victim of a medical error. A 1996 survey by AHCPR reported that 
86 percent of Americans want information about the quality of 
their doctor and 83 percent would like information about the 
quality of their hospital.
    Certainly each of us is deeply concerned about quality and 
wants to have information that would enable us to make good 
decisions for ourselves and our families. Yet, the leading 
healthcare organizations often resist such initiatives. The 
leaders of American healthcare, that is clinical directors, 
organization executives, policy researchers, have been aware of 
high medical error rates at least since 1991.
    In considering the tragic proportions of our patient safety 
problems, Congress should not labor under the presumption that 
skilled and concerned professionals will suddenly solve 
problems that have been well known for many years particularly 
when market pressures offer little reward for a commitment to 
quality care. Eighty-seven years ago Louis Brandeis argued that 
sunlight is said to be the best of disinfectants. The IOM has 
bravely embraced this principle in its recommendations, 
favoring a ``nationwide, mandatory reporting system about 
adverse events that result in death or serious harm.'' The IOM 
further states that the result of analyses of individual 
reports should be made available to the public, and I am still 
quoting, ``the public also has the right to be informed about 
unsafe conditions. Requests by providers for confidentiality 
and protection from liability seem inappropriate in this 
context'' says the IOM. Medical ethics dictates that doctors 
have a duty to disclose errors to patients and relatives, 
regardless of liability concerns, as you heard this morning.
    Shouldn't a patient facing a vital healthcare decision 
selecting a hospital for surgery or choosing a nursing home for 
an ailing parent be able to factor in that facility's safety 
record when making that decision. If any person or agency knows 
based upon reliable methods that one hospital or one nursing 
home provides safer care than another that information should 
be disclosed to a prospective patient. While we have a moral 
responsibility to let patients and families know about the 
risks they may face when entering a healthcare facility, we 
should also recognize that the health system itself will not 
become accountable until information on institutional 
performance is public.
    Entrenched cultural, technical, and management systems 
permit unsafe systems to prosper and to escape scrutiny. So 
long as health care organizations face no economic consequences 
or risk of public embarrassment when they fail to address 
safety problems, they will continue to put safety at the bottom 
of the priority list. As the Philadelphia Inquirer recently 
editorialized, ``if the counteroffensive against medical 
mistakes is shrouded in secrecy-as the error rate still is 
today-that will limit the pressure on hospitals to improve.
    There is little doubt that public disclosure increases an 
institution's sense of urgency and accountability about a 
problem. Congress needs to make sure the medical establishment 
comes clean.'' Mr. Bilirakis. Please summarize, Dr. Perry.
    Mr. Perry. I would summarize by saying that if we have both 
the responsibility ethically to the patients and their families 
and also to the system, which we would like to see improve and 
that improvement will only come when there is public 
understanding of the variability and the risks that they may 
face. Thank you.
    [The prepared statement of Daniel Perry follows:]
   Prepared Statement of Daniel Perry, Chairman, Board of Trustees, 
                     Foundation for Accountability
    My name is Dan Perry. I serve as Chairman of the Board of Trustees 
of the Foundation for Accountability, commonly known as FACCT. FACCT is 
a four-year old non-profit organization dedicated to helping Americans 
have reliable information they can use to make better health care 
decisions. FACCT was created by and continues to be governed by large 
health care purchasers and consumer organizations. Our Trustees include 
private sector leaders such as General Motors, AT&T, AARP, the National 
Coalition for Cancer Survivorship, and the National Alliance for the 
Mentally Ill as well as public purchasers such as the Federal Employee 
Health Benefit Program, the Health Care Financing Administration, and 
several state governments. In my professional life, I also serve as 
Executive Director of the Alliance for Aging Research here in 
Washington.
    Safe health care is the first concern of every patient, and must be 
recognized as a vital public interest. We applaud the work of the 
Institute of Medicine and the interested Congressional panels in 
raising public awareness about the unacceptably high rates of medical 
errors in our health system. And we are pleased that so many health 
care leaders have come forward to acknowledge the seriousness of the 
issue and the need for corrective actions.
    But we are not confident that the health professions and leading 
health care institutions are capable of correcting these problems 
without external pressure--pressure provided by every individual 
patient and by the public's collective expectation of improved care. 
The leaders of U.S. health care--clinical directors, organization 
executives, policy researchers--have been aware of high medical error 
rates since at least 1991, but cultural, structural and economic 
barriers have impeded internally generated solutions. In particular, 
FACCT believes that the culture of secrecy that has shielded health 
care performance from public view must be challenged if patient safety 
is to be improved.
    The Foundation for Accountability has developed and applied various 
measures of the quality performance of our health care system. Much of 
our own work has focused on the quality of care for chronic illnesses 
and for children's health. Wherever we look--at health plans, medical 
groups, integrated health systems--we find inconsistent and inadequate 
care being delivered to too many people. We also find a general 
unwillingness to share quality information with the public, and a 
discomfort with the basic premises of public accountability--that 
health professionals and organizations must disclose how they're doing. 
In the managed care industry, for example, only about 50% of eligible 
HMOs report the industry standard quality measures to the national 
accrediting body--and one-third of those refuse to make their data 
public. The nation's PPOs have been unwilling to collect or publish any 
quality information. In a recent California initiative to capture 
simple patient satisfaction data from hospital patients--fully funded 
by a foundation--only about half of the hospitals were willing to have 
their patients surveyed. Today, only about one-third of US hospitals 
have installed computerized medication order systems--and only one per 
cent require their doctors to use those systems!
    At the same time, our research and others' confirms that safe 
medical care is a central concern of most Americans. A recent survey by 
the American Society of Health System Pharmacists revealed that 61% 
were very concerned about being given the wrong medication in the 
hospital. The AMA found that 42% of Americans believe that they or a 
family member or friend has been the victim of a medical error. A 1996 
AHCPR survey reported that 86% of Americans want information about the 
quality of their doctor and 83% would like information about the 
quality of their hospital.
    Certainly each of us is deeply concerned about quality and wants to 
have information that would enable us to make good decisions for 
ourselves and our families. Yet the leading health care organizations 
often resist most such initiatives. The risk of public embarrassment, 
the difficulty of creating effective management systems in our highly 
fragmented health care world, and the cost and uncertainty of investing 
in computer technology prevent even the best intentions of so many 
health care professionals from achieving meaningful changes. In 
considering the tragic proportions of our patient safety problems, 
Congress should not labor under the presumption that skilled and 
concerned professionals will suddenly solve problems that have been 
well-known for many years--particularly when market pressures offer 
little reward for a commitment to quality care.
    Louis Brandeis argued--eighty-seven years ago--that ``publicity is 
justly commended as a remedy for social and industrial diseases. 
Sunlight is said to be the best of disinfectants.'' The Institute of 
Medicine bravely embraced this principle in its Recommendation 5.1, 
favoring a ``nationwide, mandatory reporting system--about adverse 
events that result in death or serious harm.'' The IOM further stated 
that ``the results of analyses of individual reports should be 
available to the public,'' (p. 75) and that ``the public also has the 
right to be informed about unsafe conditions. Requests by providers for 
confidentiality and protection from liability seem inappropriate in 
this context.'' (p. 88)
    Public disclosure of quality of care problems is important for two 
reasons--one ethical, one structural.
    First, patients have an absolute right to know about the risks they 
face when receiving medical care.
    Second, the health system will not improve until consumers 
recognize the deficiencies of today's health care system--in their own 
backyard and in understandable terms--and demand changes.
    Our failure to honor these two principles contributes to the 
persistent alienation of the public from health policy and the 
continued difficulty the nation faces in improving the performance of 
its health system.
    Medical ethics dictates that doctors have a duty to disclose errors 
to patients and relatives, regardless of liability concerns. Similarly, 
we should view the advance disclosure of risks, including the risks of 
error, as an intrinsic part of informed consent. The IOM and others 
have estimated that on the order of 3-4% of all hospital admissions 
involve some kind of avoidable error. For a mid-sized community 
hospital serving 20,000 admissions per year, that represents as many as 
800 cases in a year, enough to constitute a measurable index of 
quality. In states such as Connecticut, mandatory reporting systems 
have produced as many as 14,000 reports per year in the nursing home 
system alone--so we know that mandatory reporting can work. Shouldn't a 
patient facing a vital health care decision--selecting a hospital for 
surgery or choosing a nursing home for an ailing parent--be able to 
factor in the facility's safety record when making that decision? If 
any person or agency knows, based on reliable methods, that one 
hospital or nursing home provides safer care than another, that 
information should be disclosed to a prospective patient.
    While we have a moral responsibility to let patients and families 
know about the risks they may face when entering a health care 
facility, we should also recognize that the health system will not 
become accountable until information on institutional performance is 
public. Entrenched cultural, technical, and management systems permit 
unsafe systems to prosper and escape scrutiny. So long as health care 
organizations face no economic consequences or risk of public 
embarrassment when they fail to address safety problems, they will 
continue to put safety at the bottom of the priority list. As the 
Philadelphia Inquirer recently editorialized, ``if the counteroffensive 
against medical mistakes is shrouded in secrecy--as the error rate 
still is today--that will limit the pressure on hospitals to improve. 
There's little doubt that public disclosure increases an institution's 
sense of urgency and accountability about a problem . . . Congress 
needs to make sure the medical establishment comes clean.'' [1/25/2000]
    Finally, the avoidance of public accountability for medical error 
has damaging, if subtle, consequences for our society. By treating 
error rates as protected information subject only to professional 
review and action, we perpetuate the false notion that patients should 
be passive users of a system that possesses adequate management and 
professional controls to assure their safety. Patients remain unable to 
make good decisions, to make trade-offs between various dimensions of 
risk, benefit, and cost, and they remain unable to exert any pressure 
on the health system to change.
    Our health system is insulated from public scrutiny or constructive 
incentives. No one--doctors, hospitals, HMOs--is recognized or rewarded 
for achieving better results or providing safer care. Consumers have no 
useful information to guide them to providers who are likely to give 
them better care. In the absence of quality information, corporations 
and consumers continue to favor providers that are cheaper or more 
convenient, even though we know incredible variations in quality 
persist. Our personal and collective health is threatened by a system 
that fails to monitor and disclose its own performance and fails to 
respond to public concerns. Our health system will not materially 
improve until the public demands high quality care and evidence that 
it's being delivered. Congress should act on the IOM recommendations 
and establish a mandatory national reporting system for medical error, 
and ensure that understandable, relevant information about patient 
safety is available to every American consumer.

    Mr. Bilirakis. Thank you, sir. Dr. O'Leary.

                   STATEMENT OF DENNIS O'LEARY

    Mr. O'Leary. I am Dr. Dennis O'Leary, President of the 
Joint Commission on Accreditation of Healthcare Organizations. 
I am very pleased to have the opportunity to address you today 
concerning medical errors. This is perhaps the most pressing 
quality issue we face in healthcare today. The Joint Commission 
accredits over 18,000 organizations whose services include 
acute care, long-term care, ambulatory care, behavioral health 
care, laboratory services and home care.
    This broad experience gives the Joint Commission a 
panoramic view of the strengths and weaknesses inherent in our 
healthcare delivery system. My testimony will discuss briefly 
the important features of the Joint Commission's Sentinel Event 
Program but stress the reality that without congressional 
assistance the Joint Commission's error reporting program and 
others like it will continue to fall well short of their 
intended goals. Simply stated, the Joint Commission's Sentinel 
Event Program should be viewed by policymakers as a treasure 
cove of lessons learned in designing any program to promote 
medical error reduction.
    There are two messages that I would like you to take away 
from my testimony today. The first is that medical error 
reduction is an information problem. We believe that the 
solution to reducing the numbers of medical errors resides in 
collecting, analyzing and applying existing information about 
medical errors. The second message is that we will not be 
successful in securing access to this information if the 
Congress does not establish Federal protections that will 
permit the surfacing evaluation and sharing of that 
information.
    The Joint Commission initiated its formal Sentinel Event 
Program in 1996. In so doing, the Joint Commission saw a clear 
need to understand the epidemiology of medical errors and to 
initiate a systems approach to developing error reduction 
strategies. We designed the Sentinel Event Program to have four 
information-driven functions. The first encourages the 
reporting of specifically defined sentinel events. A sentinel 
event is our label for an unanticipated death or major 
permanent loss of function in a patient not related to the 
natural course of the patient's underlying illness.
    Because there must be incentives for error reporting, we do 
not penalize the accreditation status of an organization that 
surfaces an error and performs the required due diligence. 
However, despite the incentive to report errors to the Joint 
Commission, the fear of public castigation and litigation are 
significant impediments for most healthcare providers. We have 
therefore experienced very limited reporting to our data base. 
The second element of our program is a requirement that the 
organization conduct an indepth analysis following the 
occurrence of a sentinel event to identify the underlying 
causes of the error and to form the basis for an appropriate 
action plan.
    These root cause analyses, which we believe hold the 
critical answers to future error reduction efforts, focus 
primarily on organization systems and processes. Unfortunately, 
the majority of today's reporting systems, both voluntary and 
mandatory, fail to require or encourage the performance of 
these intensive assessments. Not surprisingly, organizations 
are hesitant to share these root cause analyses with the Joint 
Commission or anyone else.
    We must recognize that preparing a document that lays bare 
the weaknesses and healthcare provider system is akin to 
writing a plaintiff's brief. Therefore, we cannot expect 
uniform preparation of these documents without Federal 
protections against their inappropriate disclosure. The third 
feature is monitoring. The Joint Commission monitors the action 
plans of accredited organizations, which have experienced 
serious medical errors to insure that planned system changes 
are in fact implemented.
    We view the monitoring function as a key element of public 
accountability. The public must have confidence that there is 
an external body overseeing patient safety issues in the 
organizations that are delivering their care. Because error-
related data and information undergird the system of 
accountability and oversight, we also believe that any national 
reporting program must insure appropriate data sharing among 
all of the responsible oversight bodies.
    Efforts should at least be made to better utilize the 
existing private sector and public sector structures through 
improved data sharing and encourage the broad dissemination of 
what has been learned from medical mistakes. The last feature 
of the Sentinel Event Program is dissemination of lessons 
learned from errors so that all organizations may reduce the 
likelihood of similar adverse occurrences. The Joint Commission 
does this through a series of sentinel event alerts.
    To date, we have issued alerts on medication errors, wrong 
side surgery, restraint-related deaths, blood transfusion 
errors, inpatient suicides, infant abductions, and post-
operative complications. We have preliminary data indicating 
that these have significantly reduced the frequency of certain 
serious errors. The Joint Commission is pleased that the IOM 
report is galvanized the professional and policymaking 
communities around this critical set of quality issues.
    However, there is danger that in rushing to address a 
serious public policy issue all of the elements necessary to 
success may not be considered. The Joint Commission Sentinel 
Event Program contains those elements and it demonstrates very 
clearly that no reporting system for serious errors can fulfill 
its objectives without congressional help. We therefore urge 
the Congress to create statutory protections from disclosure 
and discoverability of the indepth, causal information that 
must be gathered in any mandatory or voluntary reporting 
system.
    Without clear Federal protection from disclosure of root 
cause analysis information no reporting system can achieve its 
goals for error reduction. Today we have the opportunity to 
dramatically reduce the numbers and types of errors in the 
healthcare system but we must have your help to reach this 
goal. Thank you.
    [The prepared statement of Dennis O'Leary follows:]
 Prepared Statement of Dennis O'Leary, President, Joint Commission on 
               Accreditation of Healthcare Organizations
    I am Dr. Dennis O'Leary, President of the Joint Commission on 
Accreditation of Healthcare Organizations. I am pleased to have the 
opportunity to address each of the three House subcommittees regarding 
``Medical Errors: Improving Quality of Care and Consumer Information.'' 
Medical errors is one of the most pressing quality issues we face in 
the health care industry as we approach the next millennium.
    The Joint Commission is the nation's oldest and largest standard-
setting body for health care organizations. We accredit over 18,000 
organizations that provide a wide range of services, including 
hospitalization; long term care; ambulatory care; behavioral health 
care; laboratory services; managed care; and home care. Based on its 
broad experience, the Joint Commission has a panoramic view of the 
strengths and weaknesses inherent to our health care delivery system. 
We believe that the problem of medical errors is endemic to the way 
health care is carried out, but that we have the tools and commitment 
with which to sharply reduce their incidence.
    My testimony will focus on the Joint Commission's Sentinel Event 
Program which was designed to reduce medical errors among all of our 
accredited organizations. I will discuss briefly its important 
features, and relate how the program has assuredly saved lives and 
prevented injury. But I will also stress the fact that without 
Congressional assistance, the Joint Commission's error reporting 
program will continue to fall significantly short of its intended 
goals. Simply stated, the Joint Commission's Sentinel Event Program 
should be looked to by policy makers for ``lessons learned'' when 
designing any national, state or local program of medical error risk 
reduction.
    There are two messages that I would like you to take from my 
testimony today. The first is that medical error reduction is an 
information problem. I will expand on this message by describing the 
attributes of the Joint Commission's Sentinel Event Program, which 
specifically build on this point. We believe that the solution to 
reducing the number and types of medical errors resides in developing 
mechanisms for collecting, analyzing, and applying existing 
information. If we are going to make significant strides in enhancing 
patient safety, we must think in terms of what information we need to 
obtain, create, disseminate and apply to the problem.
    The second message is that we will not be successful in performing 
these information-driven activities if the Congress does not pass 
federal protections that will encourage the surfacing, evaluating, and 
sharing of that information. I will discuss this issue in the 
concluding portion of the testimony.
                       the sentinel event program
    Concerned about a spate of serious medical errors that came to its 
attention during 1995, the Joint Commission initiated its formal 
Sentinel Event Program in 1996. It is noteworthy that the recently 
released Institute of Medicine Report, ``To Err is Human: Building a 
Safer Health System.'' lists many of the same events that spurred us 
into action four years ago. Many of these errors achieved high media 
visibility, but it became abundantly clear that these were the tip of 
the iceberg, and that even the most premier health care institutions 
were not immune to serious mistakes.
    It would be easy to attribute what appeared then to be a rise in 
errors to the increasing complexity of health care combined with 
escalating financial challenges in the health care industry. Certainly, 
health care has been experiencing restructuring, resource constraints, 
rapid technological advances, and an explosion of medical knowledge 
that makes it more difficult for practitioners to keep up with the 
latest knowledge and skill sets. As important as these factors may be, 
they should more aptly be considered exacerbating conditions rather 
than root causes of error. In fact, the very high dependence on human 
interventions and interactions characteristic of health care makes it 
prone to error. An industry so reliant upon human factors such as 
memory, emotions, communication, skills, and physical well-being must 
be supported by organizational and technologic systems to reduce the 
likelihood of mistakes.
    The Joint Commission saw the need to take a leadership role in 
helping health care organizations better understand the epidemiology of 
medical errors as well as the need for a systems approach to effective 
error reduction strategies. Therefore, the Sentinel Event Program was 
launched with the primary goal of applying scientific methodology to 
the problem to bring about a significant reduction in the numbers and 
types of medical errors.
    We designed the Sentinel Event Program with four information-driven 
functions:

1. Encouragement to report specifically defined sentinel events;
2. Requirement of the conduct of an in-depth systems (``root cause'') 
        analysis following the occurrence of a sentinel event to 
        elucidate the underlying causes of the error and to form the 
        basis for an appropriate action plan;
3. Monitoring of the organization to assure its compliance with patient 
        safety standards and implementation of the action plan; and
4. Dissemination of lessons learned from errors so that all 
        organizations may reduce the likelihood of similar adverse 
        occurrences.
Reporting of Sentinel Events
    It is imperative that any medical error reporting program operate 
under a pragmatic and carefully crafted definition of what is a 
reportable event. Standardization of the information to be collected is 
an important prerequisite for aggregating events in a consistent and 
meaningful fashion. Further, without a pragmatic definition, a 
reporting program would be flooded with hundreds of thousands of lesser 
injuries that would overwhelm the system. With this in mind, we 
identified a subset of sentinel events \1\--including their 
nomenclature and taxonomy--that would be reported to the Joint 
Commission on a voluntary basis.
---------------------------------------------------------------------------
    \1\ The Joint Commission defines a sentinel event as ``any 
unexpected occurrence involving death or serious physical or 
psychological injury, or the risk thereof. Serious injuries include a 
loss of limb or function. The phrase ``or the risk thereof'' includes 
any process variation for which a recurrence would carry a significant 
chance of a serious adverse outcome.
---------------------------------------------------------------------------
    These reportable events affect recipients of care (patients, 
residents, enrollees) and meet the following criteria:

 the event has resulted in an unanticipated death or major 
        permanent loss of function, not related to the natural course 
        of the patient's illness or underlying condition, or
 the event is one of the following:
   suicide of a patient in a round-the-clock care setting,
   infant abduction or discharge to the wrong family,
   rape,
   hemolytic transfusion reaction involving administration of 
            blood or blood products having major blood group 
            incompatibilities, or
   surgery on the wrong patient or wrong body part.
    The foregoing definition of a reportable event minimizes the 
external reporting burden to health care organizations while focusing 
on the most serious occurrences that have a high likelihood of being 
preventable. The fact that the Sentinel Event program seeks to collect 
data on the most serious errors, or ``crashes,'' distinguishes the 
Joint Commission's reporting program from the voluntary programs 
encouraged in the IOM report, which would collect information only on 
the ``near misses.''
    An important feature of the Sentinel Event Program is the non-
punitive reporting environment it seeks to create. Hoping to foster a 
positive culture that will promote error reduction efforts, the Joint 
Commission has designed the Sentinel Event policies not to penalize the 
accreditation status of an organization that surfaces an error and 
performs the appropriate due diligence required under the policy. The 
resulting atmosphere provides incentives that favor the surfacing of 
information about errors that eventually contributes to error reduction 
strategies that can be used by other organizations.
    Despite the incentive to report errors to the Joint Commission, the 
fear of public hangings and litigation are significant impediments for 
the majority of health care providers. Therefore, we have experienced 
only limited reporting to the Joint Commission's database. Over the 
years, our Sentinel Event Program has made procedural accommodations to 
protect sensitive error-related information, such as having our 
surveyors review reported errors onsite rather than having information 
sent to the Joint Commission's central office. But these manipulations 
are only stop gap measures that we believe must be replaced by federal 
protections for error-related information.
    I am going to return to the need to create a positive culture for 
reporting later in this testimony, because I believe it is the most 
important contribution that Congress can make to reducing medical 
errors nationwide. The Joint Commission has been especially pleased by 
the past support by some members of the Commerce committee for 
legislation that would promote a non-punitive environment for surfacing 
and learning from errors.
Systems Analyses to Discover Root Causes
    While reporting is voluntary, the production of a root cause 
analysis following a sentinel event is a mandatory feature of the 
Sentinel Event Program. An accredited organization that experiences a 
sentinel event must produce an intensive analysis that encompasses a 
no-holds-barred vetting of all of the causes underlying the event. We 
call these responses root cause analyses--a term borrowed from the 
engineering world's reliance on a systems approach to both solving 
problems and producing desired outcomes.
    A root cause analysis focuses primarily on systems and processes, 
not on individual performance. While an individual is almost always the 
most proximal cause of a mistake in health care, it is also almost 
always the case that the fundamental causes of error relate to systems 
failures distal to the error itself. For example, systems may fail to 
provide simple checks and balances; or they may be missing critical 
safeguards; or may have design flaws that actually promote the 
occurrence of errors.
    These intensive analyses are rich learning processes that can 
elucidate multiple factors that ultimately contributed to the error. 
Many of these are not readily apparent until the root cause analysis is 
undertaken. Therefore, the analysis must be comprehensive, thorough, 
and engage the personnel involved in all aspects of the care giving and 
support processes. These are also time consuming investigations, and 
their complexity may require external technical assistance to do well. 
The Joint Commission has developed several comprehensive guides on how 
to conduct a good root cause analysis, and continues to be the leading 
source of guidance for health care organizations in this area.
    Unfortunately, the majority of reporting systems--both voluntary 
and mandatory--fail to require or encourage the performance of these 
intensive assessments. This was evident during our review of many state 
reporting programs. A reporting system that ends with the report of the 
event itself is not a credible program and will not contribute to error 
prevention. Root cause analyses also offer extraordinary insights into 
how processes must change to control unwarranted variations, and they 
tell stories of what systems must be developed to guard against the 
occurrence of similar human error. Root cause analyses hold the promise 
of prevention. They are also the necessary substrate from which risk 
reduction action plans are created.
    Not surprisingly, organizations are hesitant about sharing these 
root cause analyses with the Joint Commission or anyone else. Although 
many organizations have done so, we must recognize that preparing a 
document that lays bare the weaknesses in a health care provider's 
system is akin to writing a plaintiff's brief for purposes of 
litigation. Therefore, we cannot expect uniform preparation of these 
documents without accompanying federal protections against their 
inappropriate disclosure.
Monitoring Action Plans and Safety Standards
    The Joint Commission monitors the action plans of accredited 
organizations which have experienced serious medical errors, in a 
manner similar to the way we monitor any quality of care area in need 
of improvement. This ensures that there is an independent review of the 
milestones associated with anticipated systems changes. Monitoring is 
an important part of the strategy for preventing errors, to ensure that 
the response to an error does not terminate in only the report itself 
or a discussion of what went wrong. We want to see an organizational 
response that results in preventive actions.
    The Joint Commission developed explicit patient safety standards 
that became applicable to accredited organizations beginning in January 
1999. These new standards were specifically created to establish 
patient safety as a high priority in provider organizations.
    The new standards require that the leadership of a health care 
organization establish processes for identifying and managing sentinel 
events and put these into practice. The standards also require that the 
organization monitor performance of particular processes that involve 
risks or may result in sentinel events, and intensely analyze 
undesirable patterns or trends in performance. The standards make 
patient safety a visible responsibility of health care organizations 
and a requirement for accreditation. Compliance with these new patient 
safety standards is evaluated through our onsite inspection process.
    We view the monitoring function as a key element to public 
accountability. The public must have confidence that there is an 
external body requiring attention to patient safety within the 
organization that is delivering their care. We believe that the public 
views safety as a threshold concern. While citizens probably do not 
wish to have detailed data about safety prevention in each health care 
organization, they should reasonably expect that responsible oversight 
bodies are acting conscientiously and effectively on their behalf. This 
includes aggressive and timely follow-up to the occurrence of a serious 
medical error and holding the organization accountable for making 
necessary systems improvements. That assurance must be provided to the 
American public.
    At the same time, it is error-related data and information that 
undergird and drive this system of accountability and oversight. 
Therefore, we believe that any national response to the IOM report must 
ensure appropriate data sharing among all of the responsible oversight 
bodies which perform any of the functions discussed in this testimony. 
The health care quality oversight system has a variety of private 
sector and public sector players today. Efforts should at least be made 
to better utilize existing structures through improved data sharing and 
encourage the broad dissemination of what has been learned from medical 
mistakes.
Dissemination of Lessons Learned
    To have a positive national effect on patient safety, information 
gleaned from errors must be aggregated, analyzed and disseminated to 
the health care community at large. The Joint Commission began its 
series of Sentinel Event Alerts to share the most important lessons 
learned--known risky behaviors as well as best practices--from its 
database of error-related information. To date we have issued Alerts in 
a number of areas, including medication errors; wrong site surgery; 
restraint-related deaths; blood transfusion errors; inpatient suicides; 
infant abductions; and post-operative complications.
    We are confident that these Alerts have saved lives. Unfortunately, 
we cannot calculate real decreases in error rates with scientific 
certainty, because the full scope and frequency of serious adverse 
events is simply not known. However, we have some data which 
illustrates the effects of our Sentinel Event program in selected 
areas. For example, we have seen a notable significant effect from our 
first Alert dealing with the importance of appropriate storage and 
handling of potassium chloride (KCl)--a substance that is deadly when 
given in concentrated form and is easily mistaken for less benign 
substances. In analyzing the causes of KCl-related deaths in 1997, it 
became evident that accidental injection of KCl stored on hospital 
floors was an important cause of unanticipated deaths. The Joint 
Commission issued its Alert on the subject in February 1998. The number 
of reported deaths has dropped from about 12 the year before to only 
one in 1998 and one in 1999.
    We believe that significance should be attached to how information 
is disseminated and by whom. The risks associated with potassium 
chloride have long been known to practitioners. But when the principal 
accreditor of provider organizations issued a major alert, it caught 
the attention of organization leaders and health care practitioners. 
Moreover, it was clear to the recipients of the information that the 
Joint Commission would be paying attention to this particular issue and 
following up during onsite evaluations of the organization's 
performance. This program of Alerts is an example of the type of 
vehicle necessary to achieve behavior change in health care 
organizations.
                     need for congressional action
    The Joint Commission is pleased that the IOM report has galvanized 
the professional and policy making communities around this critical set 
of quality issues. Such synergy of purpose among stakeholders is a 
prerequisite for solving complex, multifactorial problems that depend 
upon information sharing among the parties. Dramatically reducing the 
numbers and types of errors will take a concerted effort by all who 
play a role in the health care system.
    However, there is always the danger that in rushing to address a 
serious public policy issue, all of the elements necessary to success 
are not considered. The Joint Commission's Sentinel Event program 
contains those elements, but it demonstrates very clearly that no 
reporting system for serious errors can fulfill its objectives without 
Congressional help. We urge, therefore, that Congress create statutory 
protections from disclosure and discoverability of the in-depth, causal 
information which must be gathered in any mandatory or voluntary 
reporting program for serious adverse events.
    The Joint Commission took this position publicly several years ago 
in seeking federal confidentiality protections for the root cause 
analysis information produced in response to a serious medical error. 
Soon after we began our Sentinel Event Program, many organizations 
expressed grave concerns that existing peer review statutes would not 
adequately protect the production and sharing of the intensive 
analyses. In fact, the Joint Commission's subsequent review of state 
laws verified that they were inconsistent and often unclear about the 
extent to which health care organizations can share with accreditors or 
other third party external review organizations any assessments of 
cause and still maintain peer review protections.
    Therefore, the Joint Commission began seeking federal legislative 
protection which would make clear that information developed in 
response to a sentinel event--and shared with an accreditor--would be 
provided clear protections from disclosure and discovery. We are 
convinced that without such clear federal protection from disclosure of 
root cause analysis information, no reporting system will achieve its 
goals for error reduction. We believe this to be true for both 
mandatory and voluntary programs, for serious errors or programs for 
near misses.
    Fear of reprisals, public hangings, and loss of business will 
continue to impede both reporting and the production of in-depth, 
intensive investigations of the root causes behind medical errors. 
Rather than surfacing reports of errors, our blame-and-punishment-
oriented culture drives them underground. Congress can make an 
extremely critical contribution to solving the information problem by 
passing legislation to address these legitimate fears.
    We also encourage you to consider all of the elements contained in 
the Joint Commission's Sentinel Event program as components necessary 
to the successful address of the problem of medical errors, 
irrespective of whether solutions are considered at national, state or 
local levels. To actually accomplish the tasks presented in this 
testimony, many stakeholders must play roles. This will take 
significant data sharing between the public and private sectors to 
ensure that all of these functions can be effectively carried out.
    Thank you for the opportunity to present our views.

    Mr. Bilirakis. Thank you very much. Dr. Golden.

                 STATEMENT OF WILLIAM E. GOLDEN

    Mr. Golden. Yes, good morning, Mr. Chairman. As Principal 
Clinical Coordinator for a Medicare Peer Review Organization, I 
am very pleased to be here today to discuss the issue of 
medical errors. While I spend substantial time at the Arkansas 
Foundation for Medical Care, I am also Professor of Medicine at 
the University Medical School in Little Rock. The PRO has 
extensive experience in performance measurement and conducts 
quality improvement, HEDIS measurements, and patient 
satisfaction surveys for Medicaid as well as for Medicare.
    We have supplied the Joint Commission Oryx Program with 10 
percent of its national core measures proposed for its system. 
Today as President of the American Health Quality Association, 
I would like to address issues that reflect the concerns and 
the capabilities of the QIOs, which are members of the HQA, an 
association of organizations and individuals dedicated to 
healthcare quality improvement. QAOs are private, community-
based, work in all healthcare settings, outpatient and 
inpatient nursing homes and are in all 50 States, including 
District of Columbia and the U.S. territories.
    We all work together on our 3-year programs and contracts 
with the Health Care Financing Administration to improve 
quality of care for Medicare beneficiaries. Over the last 10 
years the PROs have evolved into a national network of quality 
improvement experts that systematically evaluate the delivery 
of healthcare in a region and institute projects to educate and 
alter the clinical behavior of institutions, health 
professionals and patients.
    We have assembled staffs of clinical experts, nurses and 
physicians, data and statistical professionals, medical record 
abstraction teams. We have an extensive infrastructure of 
relationships with community hospitals and physicians who have 
expertise in outreach strategies. In fact, the studies that you 
heard today from Colorado and Utah were performed--the 
abstraction and the data was collected by PRO staff.
    The IOM points out two kinds of errors, errors of omission, 
errors of commission involved with the prevention, diagnosis 
and treatment of illness. Much of the PRO system currently 
works to reduce errors of omission in prevention, diagnosis and 
treatment. Examples include improving the rates of mammography, 
increased use of pneumoccal vaccine and influenza vaccine, 
making sure patients get appropriate drugs after a myocardial 
infarction to avoid subsequent myocardial infarctions, 
antibiotics for the treatment of pneumonia, making sure 
patients get appropriate therapy for congestive heart failure, 
better monitoring of diabetes and its complications.
    We even do work on areas of commission. One project right 
now is to eliminate the use of a dangerous drug used in the 
acute treatment of stroke. We have attached 22 performance 
indicators that we are currently working on nationwide to 
improve care and reduce errors in the Medicare program. The 
PROs serve as a good model for a national patient safety 
program because these indicators affect a large percentage of 
elderly Americans. They have a strong scientific basis and they 
also are a standardized system that allows comparison and 
performance between regions, between States, pre and post 
project activity.
    We have seven recommendations for improving patient safety 
and to reduce errors in this country. One is to expand the 
current performance monitoring system that the PROs are 
currently involved with. There are many areas that we could 
focus activity including adverse drug events, hospital acquired 
infections, pulmonary embolism, post-operative hemorrhage. We 
agree that the Agency for Healthcare Research and Quality, 
HCFA, the QIOs and other professional groups should work 
together to define the highest priority areas for scrutiny for 
error prone healthcare processes.
    We need focus and we need to define what we are going after 
to achieve results. It is important that a system of monitoring 
that we have to expand upon would not impose undue burdens to 
these hospitals because the current system using administrative 
data sets and data abstraction teams can conduct and collect 
most of this information with minimal burden to the 
institutions.
    Our second suggestion is to require mandatory reporting of 
catastrophic errors. Some of these random and adverse accidents 
that occur, which we have been hearing about, do not get fully 
reported, and we believe that a data base would be very useful 
for us to find root causes and to allow institutions that have 
not seen the errors to learn from errors at other settings and 
put in place patient safety practices to reduce the incidence 
of these events in the future.
    We would like to assure accountability of the system and 
that these medical error collection systems should be handled 
by a qualified expert organization that is independent of the 
hospital providers and is capable of analyzing incidence of 
errors and the response to those errors and find best 
practices. PROs are especially accountable to the system 
because we are under Federal contracts to improve the 
performance of the healthcare system in their region.
    Fourth, we want to assure confidential treatment of 
reported errors, as many have mentioned. We want to encourage 
reporting, not discourage and punish people for helping develop 
a safer system. And we believe that a collection system at the 
State level would be of assistance. Confidentiality of course 
is important. We would like to establish a mechanism to find 
unreported errors by surveillance much like we saw in the 
Colorado and Utah studies where random surveillance of charts 
by qualified experts could find these errors and collect more 
information to improve the system.
    We can promote best practices by finding institutions that 
have implemented good practices and share them with others. One 
system that we had in our State reduced the use of myocin to 
reduce hospital infections and that has now become a national 
model after being shared with our institutions. And finally we 
want to separate malpractice reform from error reduction. We 
believe that is a very complex topic but these suggestions that 
we have made today can go a long way to make the system safer 
for patients, and malpractice reform is almost a separate topic 
that goes apart from these issues here that can improve the 
system for all of us. Thank you.
    [The prepared statement of William E. Golden follows:]
Prepared Statement of William E. Golden, President, The American Health 
                          Quality Association
    Good morning, Mr. Chairman. As the Principal Clinical Coordinator 
for a Medicare Peer Review Organization, and as a physician who has 
treated hundreds of veterans in VA medical centers, I am particularly 
happy to have this opportunity to participate in a joint hearing of the 
Commerce Committee and the Veterans' Affairs Committee on the important 
problem of medical errors.
    While I spend most of my professional time working for the Arkansas 
PRO, I am also a Professor of Medicine and Director of General Internal 
Medicine at the University of Arkansas Medical School. The Arkansas PRO 
has extensive experience in performance measurement and conducts 
quality improvement, HEDIS measurement, and patient satisfaction 
surveys for the state Medicaid program. We are also a recognized vendor 
for the Oryx Program of the Joint Commission on Accreditation of 
Healthcare Organizations (JCAHO). In fact, we created three of JCAHO's 
thirty performance measures in the proposed national core program.
    I am here today as President of the American Health Quality 
Association (AHQA), a national membership association of organizations 
and individuals dedicated to health care quality improvement. Our 
member Quality Improvement Organizations (QIOs) are private, community-
based organizations that promote health care quality in all health care 
settings. QIOs work in all 50 states, the District of Columbia and the 
U.S. Territories.
    The QIOs have several lines of business including work with state 
governments and private health plans. The work that unites them all, 
however, is their 3-year, competitively awarded contracts from HCFA to 
evaluate and improve the quality of care delivered to Medicare 
beneficiaries. For this work, our members are more commonly referred to 
as Medicare Peer Review Organizations, or PROs.
    Congress established the PROs in 1983 to look for single case 
problems. During the 1990s, the PRO system evolved to become a national 
network of quality improvement experts that systematically evaluate the 
delivery of health care in a region and institute projects to educate 
and alter the clinical behavior of institutions, health professionals 
and patients. QIOs are staffed with clinical experts, communication 
experts, and data and statistical professionals who work together to 
analyze and collaborate with the health care system in their 
communities.
    Today's PRO system is uniquely qualified to serve as the core of a 
new national system for improving patient safety. One of the greatest 
strengths of the PRO system is its extensive infrastructure of 
relationships in every region of the country. PROs work individually 
with hospital staffs and physicians offices. They are also increasingly 
engaged with home health care systems, nursing homes, academic health 
centers, and community groups such as heart associations and cancer 
coalitions.
    In addition to technical expertise, they have developed public 
relations and outreach strategies with professional associations, 
public health authorities and state officials. This is critical for 
helping hospitals and other facilities implement improvement strategies 
as well as tailoring messages to the public about improving their 
health (e.g. public awareness of receiving pneumococcal vaccinations or 
getting regular eye examinations to reduce the risk of diabetes-related 
blindness). This is also critically important for the effectiveness of 
the PROs' required projects with underserved and disadvantaged 
populations. These projects often require forms of outreach and 
communication that are culturally appropriate.
    The Institute of Medicine (IOM) report released last November 
targets both medical errors of omission--care not provided that should 
have been--as well as errors of commission. In addition, the IOM 
Committee also states that errors occur and should be detected in all 
phases of medical care: prevention, diagnosis and treatment.
    The Medicare PRO Program as a Model Error Reduction Program. 
Medicare's national PRO system has been identifying, measuring and 
reducing error rates for several years. The PRO program is now 
embarking on an expanded three-year mission to identify and eliminate 
medical errors. The new program is focused largely on errors of 
omission--such as prescriptions that were not ordered for prevention of 
heart attack--and on errors in all three categories mentioned by the 
IOM. For example, in the prevention area, PROs are working to promote 
immunizations to prevent the most common fatal infection, pneumococcal 
disease. In the area of missed diagnoses, the PROs will be working to 
increase mammography screening and diabetic retinopathy testing. An 
example of PRO work to reduce treatment errors is that PROs will be 
emphasizing timely administration of antibiotics for newly hospitalized 
pneumonia patients.
    I have attached a complete list of the 22 performance indicators in 
each of six clinical topic areas for which the PROs must reduce error 
rates. These PRO performance indicators serve as a useful model for a 
new medical error reduction system for several reasons. These clinical 
topics were carefully chosen because they affect a large percentage of 
older Americans and because the scientific basis for the desired 
therapy or action is well established. A national error reduction 
program should also focus on high priority problems and adopt a 
science-based approach.
    In addition, the standardized national set of performance 
indicators assures national comparability of data within and between 
all states, which is critical to accurately measure improvement. We 
believe this is a sound model for a national system of identification 
and reduction of medical errors.
    Recommendations. Based on our experience working within a national 
system to identify quality problems and work collaboratively with 
providers to bring about improvement, here are our recommendations for 
a new system for improving patient safety.
    1. Expand Monitoring System for Error Prevention. Congress should 
expand the current system utilized by Medicare to monitor a targeted 
list of health care processes and patient conditions known to be 
associated with a disproportionate amount of medical errors. This 
system will identify many errors and adverse events which have not yet 
resulted in dramatic or catastrophic patient outcomes.
    The published literature identifies some categories of preventable 
adverse events that are both relatively frequent and frequently 
preventable, and might be targeted by a national monitoring system. 
Some examples include adverse drug events, hospital acquired 
infections, deep venous thrombosis, postoperative hemorage. The Agency 
for Healthcare Research and Quality (AHRQ) and the Health Care 
Financing Administration (HCFA) should collaborate with representatives 
of our national network of Quality Improvement Organizations (QIOs), as 
well as professional and provider groups to define the highest priority 
areas of scrutiny for error-prone health care processes, and to develop 
a standardized system for measurement.
    Congress will be asked to consider the burden of error reporting. 
The system of monitoring that I have described can be accomplished 
without imposing significant additional reporting burdens on hospitals 
or other providers. PROs can accomplish much of the data gathering 
necessary by expanding their current mechanisms for review of medical 
records and abstraction of key data for analysis. Quality improvements 
based on this kind of monitoring will probably continue to be the major 
method by which patient safety is enhanced. Because the PRO program has 
already established the relationships with hospitals necessary to 
perform this function, there is very little new work that hospitals 
must do to facilitate an expanded program to address errors in patient 
care planning and execution.
    2. Mandatory Error Reporting. We have recommended that Congress 
devote substantial resources to monitoring and educating providers 
about the adverse events that have strong potential to harm patients, 
rather than wait for patient harm to occur. But the smaller number of 
more dramatic events that result in patient harm must also be addressed 
by an error reduction system because the results of such errors are so 
often tragic and irreversible. This subset of adverse events often 
captures the attention of local health professionals and often results 
in demands for system changes to eliminate recurrence.
    Health facilities should report the rare and seemingly random 
adverse events that result in patient harm to a regional entity to 
create a database. Monitoring and analysis of such a database can offer 
insight into better system design for all of our communities. The 
reporting of such errors allows for hindsight analysis to be available 
throughout the health system, so that more people can benefit from the 
analysis than just those in the local environment that witnessed the 
adverse event. The PROs are well qualified to manage and interpret such 
a database in each state, and have proven adept at educating providers 
and practitioners about ways to avoid errors in the future.
    3. Ensure Accountability. Congress should hold providers 
accountable for measurably reducing the incidence of errors. A 
qualified expert organization, completely independent of hospital 
providers, should analyze the incidence of errors and judge whether 
improvements are being made. The PRO program is already performing this 
function on a more limited scale. For the period 2000-2002, PROs will 
be accountable under their Federal contracts for measuring and reducing 
the frequency of missed prescriptions to prevent strokes and heart 
attacks, or missed lab tests to help control diabetes. If a PRO cannot 
accomplish sufficient measurable improvement, it may lose its Federal 
contract. In a new medical error system, Congress can rely on the QIOs 
to measure error rates and identify providers that have made no 
progress in eliminating errors. Providers that are making no progress 
on errors could be reported to a regulatory body such as the 
appropriate federal or state agency, or to the Joint Commission for 
Accreditation of Healthcare Organizations (JCAHO).
    4. Assure Confidential Treatment of Reported Errors. Reports 
identifying specific providers and individuals should generally not be 
disclosed. Part of the reason for this is that ``naming names'' tends 
to fix blame, even when this is inappropriate. The IOM report [page 45] 
noted, ``Complex coincidences that cause systems to fail rarely have 
been foreseen by the people involved.'' This suggests that it is more 
important to understand system failures than to attempt to affix blame 
on one or more individuals involved in a system failure.
    It is critically important to not to discourage, let alone punish, 
the active search for errors. Several studies demonstrate that errors 
are much more numerous than anyone can know without actively digging to 
find them. The IOM relied on two large studies of the prevalence of 
medical errors. PROs, in fact, did the medical record abstraction for 
the second study, based in Utah and Colorado. Both studies found a 
large number of preventable adverse events through careful review of 
the medical record. But these researchers also noted that many other 
errors could not be found in the medical record alone. When researchers 
at the LDS Hospital in Salt Lake City wanted to find out the true 
incidence of adverse drug events in their institution, they started by 
counting the incident reports filed by doctors, nurses, and 
pharmacists. They came up with about 20 reports a year. But after 
extensive mining of lab data, prescription records, and interviews with 
hospital personnel, they found the true incidence of adverse drug 
events was over 580 events a year. The hospital then tracked down the 
causes of these problems and reduced their true error rate below the 
original apparent rate.
    The LDS project puts the idea of public reporting in context. If 
hospital personnel know that any error they find involving patient harm 
will be subject to public reporting, few will undertake the costly and 
difficult investigations that are necessary to discover errors. If 
public disclosure and punishment await those who dig effectively to 
find the true extent of errors, few errors will be found, and fewer 
still will be eliminated.
    Congress has repeatedly recognized the importance of maintaining 
confidentiality for sensitive internal hospital quality improvement 
activities. For example, Federal law ensures that confidential data 
reported to PROs shall not be disclosed. Congress can ensure 
confidential treatment of this information by requiring that error 
reports be sent to the PRO in each state. The current PRO statute 
protects such information from unauthorized disclosure. Public 
reporting of errors should be reserved for those institutions 
identified by the PRO that cannot or will not improve error rates.
    At the state level, aggregate information without identifiers for 
individuals or institutions could be released to the general public. 
Data reported at the national level would first be encrypted for 
aggregate public reporting and would then be considered a publicly 
accessible dataset.
    5. Establish a Mechanism to Find Unreported Errors. Experience with 
other mandatory reporting systems for errors and health quality 
problems reveals that no mandatory reporting system will receive all 
appropriate reports. A separate mechanism to identify unreported errors 
is needed. One such system is already in place nationwide. Individual 
PROs periodically request records and analyze them for indicators of 
errors such as delayed administration of antibiotics in newly 
hospitalized pneumonia patients, and missed opportunities to prescribe 
medications to heart attack and heart failure patients. In addition, 
the national PRO program also utilizes clinical data abstraction 
centers (CDACs) to accomplish this task. These centers also observe 
strict confidentiality in managing the records, and have achieved a 
high degree of reliability in finding and reporting errors to PROs, 
which then work with the hospitals to prevent their recurrence. This 
system can be utilized to find many more types of errors.
    Institutions should be required to provide information in response 
to a PRO request to actively identify or pursue information that may 
not be readily identifiable in standardized reports. This mechanism 
will help to ensure the integrity of the mandatory reporting system, as 
it may uncover reports that should have been filed with the PRO but 
which were not.
    6. Promote Best Practices. Once errors are found, their causes must 
be understood, and solutions must be implemented. This is now 
accomplished through the national Medicare PRO program by collecting 
from each PRO their successful interventions to improve care, and then 
sharing it with all the rest. In this way, every PRO can approach local 
institutions with the benefit of the best knowledge of all the PROs and 
providers that have previously tried to solve a problem. By assisting 
hospital personnel in finding best practices, the PROs go far beyond 
merely holding hospitals accountable for their failures.
    7. Separate Malpractice Reform from the Error Reduction Program. 
Tort reform and facilitation or limitation of litigation is a matter 
for a separate set of public policy deliberations. All information 
should be reported to the PROs for the purpose of assuring that 
measurable quality improvement is accomplished. Neither regulatory 
remedies nor liability law need be affected by reports to the PRO or by 
the confidentiality protections afforded such reports.
    AHQA believes these are the basic elements necessary for creating a 
systematic approach to reducing medical errors that will assure both 
medical professionals and patients that the problem is being addressed 
fairly and effectively. The key to a successful solution to this 
problem will be giving the medical community the opportunity to fully 
identify the possible extent of their errors and do the work necessary 
to systematically and measurably improve. Without this measurable 
improvement, the problem will continue to be discussed but never solved 
and consumers will never be assured that the quality of their medical 
care will become any better. The nation's QIOs can provide the 
accountability and results that the system will require.
    Thank you again for the opportunity to share this information with 
Congress. I look forward to continued discussion as you work to improve 
the safety of patients across America.

                     National Health Quality Improvement Projects of Medicare PROs 1999-2002
----------------------------------------------------------------------------------------------------------------
                                          Quality Indicators
                                            (proportion of       Data Sources (Medicare      Expected Health
            Clinical Topic                  beneficiaries              FFS Only)                 Outcomes
                                             receiving:)
----------------------------------------------------------------------------------------------------------------
Acute MI.............................  Early administration of  Hospital medical         Inpatient mortality
                                        aspirin on admission.    records for AMI          rates
                                       Early administration of   patients.               Mortality rates at 30
                                        beta blockers on                                  days
                                        admission.                                       Mortality rates at 1
                                       Timely reperfusion.                                year
                                       ACE inhibitors for low                            Readmission rates with
                                        left ventricular                                  AMI
                                        ejection fraction.
                                       Smoking cessation
                                        counseling during
                                        hospitalization.
                                       Aspirin at discharge.
                                       Beta blockers at
                                        discharge.
CHF..................................  Angiotensin-related      Hospital medical         Inpatient mortality
                                        drugs for left           records for heart        rates
                                        ventricular ejection     failure patients.       Mortality rates at 30
                                        fraction when                                     days
                                        appropriate.                                     Mortality rates at 1
                                                                                          year
                                                                                         Readmission rates w/
                                                                                          CHF
Pneumonia............................  State Influenza          Flu and pneumonia        Hospital admission
                                        vaccination rate.        immunizations--Claims    rates
                                       State Pneumococcal        or survey similar to    Hospital readmission
                                        vaccination rate.        CDC's BRFSS.             rates
                                       Inpatient Influenza      Other indicators:        Inpatient mortality
                                        vaccination (or          Hospital medical         rates
                                        screening).              records for pneumonia   Mortality rates at 30
                                       Inpatient Pneumococcal    patients.                days
                                        vaccination (or                                  Readmission rates with
                                        screening).                                       Pneumonia
                                       Blood culture before
                                        antibiotics are
                                        administered.
                                       Appropriate initial
                                        empiric antibiotic
                                        selection.
                                       Initial antibiotic dose
                                        within 8 hours of
                                        hospital arrival.
Stroke/TIA and Atrial Fibrillation...  Discharged on warfarin,  Hospital medical         Inpatient mortality
                                        aspirin or other         records for stroke,      rates
                                        antiplatelet drug        TIA, and chronic        Mortality rates at 30
                                        (stroke or TIA only).    atrial fibrillation      days
                                       Discharged on warfarin    patients.               Readmission rates with
                                        (chronic atrial                                   stroke/TIA
                                        fibrillation only).
                                       Avoiding inappropriate
                                        use of sublingual
                                        nifedipine (stroke or
                                        TIA only).
Diabetes.............................  Biennial retinal exam    Claims for all diabetic  Mortality rates at 1
                                        by an eye professional.  beneficiaries.           year
                                       Annual HbA1c testing.                             Rate of development of
                                       Biennial lipid profile.                            diabetic retinopathy
                                                                                         Rate of development of
                                                                                          ESRD
Breast Cancer........................  Biennial mammography     Claims for all female    Percent of new cases of
                                        screening.               beneficiaries.           breast cancer detected
                                                                                          at stage 1
----------------------------------------------------------------------------------------------------------------


    Mr. Bilirakis. Thank you, Doctor. Dr. Langberg.

                STATEMENT OF MICHAEL L. LANGBERG

    Mr. Langberg. Mr. Chairman, my name is Dr. Michael 
Langberg. I am the Senior Vice President and Chief Medical 
Officer of Cedars-Sinai Health System in Los Angeles. The 
Cedars-Sinai Medical Center is the largest, not-for-profit 
acute care hospital in the western United States. Together with 
more than 2,000 physicians associated with our system, Cedars-
Sinai provides care to an urban population of considerable 
diversity. I have spent almost all of my professional career at 
Cedars-Sinai as a general internist.
    Since 1996, I have served as its chief medical officer and 
am responsible for overseeing system wide quality initiatives 
and information systems. In the course of this I have developed 
a deep knowledge of the complexity of modern health care and 
have a broad background in improving the quality and the safety 
of patient experience. I am here today on behalf of the 
American Hospital Association. The AHA realizes that the entire 
health community has to address the serious issues raised in 
the Institute of Medicine's report on medical safety.
    I also want to share with you some of what the hospitals 
and health systems are doing in this critical area. To begin, I 
would like to remind the committee and the American public that 
hospitals provide care to millions of patients safely every 
year. People who deliver healthcare, the doctors, the nurses 
and others, are highly trained, receive continuous education 
and strive every day to deliver safe and compassionate care.
    They believe in the dictum, first, do no harm, but 
healthcare today is extraordinarily complex and even our best 
intentions can have unwanted and unintended consequences. The 
IOM report, To Err Is Human, points out that as good as our 
systems are for preventing and reducing medical errors of all 
kinds, we can and must do better. We applaud the members of the 
IOM committee for developing a report that shines a bright 
light on the problem of medical errors and are heartened by the 
quick response this has received.
    We agree with the report in urging all to avoid blaming 
individuals for past errors and instead to focus on preventing 
future errors by designing safety into the system. This 
stresses two principles that we have learned reduce errors and 
increase patient safety. First, to err is human. We must 
understand and improve the systems in which people work to make 
errors less likely. As a result, reducing errors requires us to 
design and implement more error resistant systems.
    Second, we have to create an environment where caregivers 
feel they can come forward when an unfortunate mistake does 
occur. We need to create a non-punitive environment that allows 
the candid discussions of errors, their sources and their 
causes. If we cannot discuss our mistakes, we cannot learn from 
them or prevent them.
    The AHA also agrees that stepped up efforts are needed. 
There are many organizations today that specialize in the area 
of reducing and preventing medical errors. We at the AHA are 
working with some of these experts. In December the AHA 
announced an initiative to target and improve medication 
safety. Why? Because medication-related errors are one of the 
most common sources of all medical errors. As part of this 
initiative the AHA formed a partnership with a highly respected 
organization in this field, the Institute for Safe Medication 
Practices.
    This non-profit research and education organization and its 
President, Michael Cohen, have been dedicated for over 25 years 
the continual reduction of medication errors throughout the 
healthcare system. We are pleased that they will provide 
leadership and the technical expertise for AHA's initiative. As 
part of our effort, we will share with every one of our members 
successful practices for improving medication safety. We have 
already sent a quality advisory on improving medication safety 
to our 5,000 hospital and health system members.
    This advisory includes background on the issue, resources 
our members can turn to for help, and a three-page list of 
successful practices for improving medication safety. We will 
follow up on how the successful practices are being implemented 
with a medication safety awareness assessment. We will also 
serve as a clearinghouse for information and resources and are 
planning a national summit involving other organizations and 
hospital leaders to discuss widespread efforts to improve 
medication safety.
    In summary, Mr. Chairman, the IOM's report is timely. It 
brings together a number of stakeholders all at the same time 
to collectively address this important issue. As the report 
notes, large complex problems require thoughtful multi-faceted 
responses. The AHA is pledged and committed to keep its member 
hospitals and health systems responsive to this critical issue. 
I will be happy to answer any questions.
    [The prepared statement of Michael L. Langberg follows:]
   Prepared Statement of Michael Langberg, Senior Vice President for 
 Medical Affairs and Chief Medical Officer, Cedars-Sinai Health System 
             on Behalf of the American Hospital Association
    Mr. Chairmen, I am Michael Langberg, M.D., senior vice president 
for medical affairs and chief medical officer of Cedars-Sinai Health 
System in Los Angeles. I am here today on behalf of the American 
Hospital Association's (AHA) nearly 5,000 hospital, health system, 
network, and other health care provider members. We are pleased to have 
the opportunity to testify on an issue of critical importance for 
hospitals and the patients and communities they serve: the Institute of 
Medicine's (IOM) report on medical safety, and what hospitals and 
health systems are doing to improve patient safety.
    The Cedars-Sinai Health System includes a number of physician 
officers distributed across the Los Angeles metropolitan area. Cedars-
Sinai Medical Center is the largest not-for-profit acute care hospital 
in the western United States. Together with the 2,000 physicians 
associated with our system, Cedars-Sinai provides care to an urban 
population of considerable racial, ethnical, social, linguistic, 
religious and economic diversity.
    I have spent almost all my professional career at Cedars-Sinai on 
the faculty in General Internal Medicine, originally as Director of 
Medical Education. In 1996, I assumed the role of chief medical officer 
overseeing system-wide quality initiatives and information systems. I 
have developed a deep knowledge of the complexity of modern health 
care, and have a broad background in improving the quality and safety 
of the patient experience. I believe that much of what is outlined in 
the IOM report is accurate. The report has focused attention at a time 
when many other activities are under way to address these issues, which 
many of the members of the IOM panel first brought to national 
awareness several years ago.
                               background
    For thousands of years, healers have lived by the motto primum non 
nocere--first, do no harm. The nurses, doctors, and others on the 
patient care team in hospitals strive every day to deliver the safe, 
compassionate care that patients deserve. But in today's complex, high-
tech world of medicine, our best intentions can have unwanted and 
unintended consequences. The IOM report, ``To Err is Human: Building a 
Safer Health System,'' points out that, as good as our systems are for 
preventing and reducing medical errors of all kinds, we can and must do 
better.
                      the iom report and hospitals
    We applaud the members of the IOM Committee on Health Care in 
America for developing a report that shines a bright yet objective 
spotlight on the problem of medical errors. The IOM report is 
important, outlining the significance of the medical error problem in 
this country.
    It acknowledges that medicine is delivered by people who are highly 
trained and receive continuous education to stay on top of their 
respective areas of discipline. Hospitals and caregivers already work 
under strict internal quality control procedures, in addition to 
federal, state, local and independent oversight. Hospitals have 
important systems in place--checks and balances to reduce the potential 
for human error. For example, they have quality teams, physicians and 
nurses who examine unexpected deaths, treatment errors and accidents, 
to identify and correct the cause. And most hospitals have teams of 
experts whose sole focus is to develop and oversee safety policies to 
prevent accidents before they happen.
    In addition, there are many organizations that specialize in the 
area of reducing and preventing medical errors. The AHA is working with 
several of these organizations so that we can help hospitals and health 
systems benefit from their knowledge and expertise. Among them: the 
National Patient Safety Partnership--a public/private partnership of 
organizations; the National Coordinating Council for Medication Error 
Reporting and Prevention; and the American Medical Association National 
Patient Safety Foundation. We're doing this because, as the IOM report 
points out, a vigilant, ongoing, stepped-up effort to improve patient 
safety is needed.
    We agree with the report that we need to avoid ``blaming 
individuals for past errors'' and instead ``focus on preventing future 
errors by designing safety into the system.'' We also agree that, as 
the report states, ``professional societies and groups should become 
active leaders in encouraging and demanding improvements in patient 
safety.'' The AHA is committed to being just that kind of leader, so 
that America's health care system does indeed focus not on blame, but 
on prevention.
    The IOM report focuses on the broad issue of medical safety. The 
AHA, at a White House event in December with President Clinton, 
announced an initiative to improve medication safety, because 
medication errors are one of the most common sources of overall medical 
errors. We used the opportunity to point out that whatever happens at 
the national level will only be valuable if it helps the women and men 
like me and those I work with at the Cedars-Sinai Health System--people 
who are on the front lines of health care--do their jobs even better.
    Speaking of action at the national level, we understand the 
committee's interest in determining whether further legislation is 
needed to address medication errors. But before moving to consider new 
legislation, we urge Congress to consider the reporting mechanisms 
currently in place--by organizations like the Veterans Administration, 
the Joint Commission on the Accreditation of Healthcare Organizations, 
and the Institute for Safe Medication Practices--to collect and use 
information on errors. Congress should know how these current 
mechanisms work and consider ways to improve them, if necessary, before 
proposing new reporting systems.
    The AHA believes we need to be clear about what our objectives are 
in collecting information on events that may be related to errors. 
Reporting should be a tool for reducing and preventing errors. It 
should be designed to stimulate organizations and practitioners to 
analyze what went wrong and make the necessary changes to ensure that 
the mistakes do not happen again. In addition, lessons learned from one 
error should be widely shared with others. Provider accountability 
should be tied to these objectives.
    The quantity of reports is not nearly as important as the quality. 
One need not read 500 reports of workers mixing up two similar sounding 
medications, before it becomes obvious that the two medications need 
better labeling. Our goal should not be to ensure that every provider 
report every event, but rather to encourage dialogue to learning.
                             aha activities
    More than a year ago, the AHA board and many of our hospital 
leaders attended a national forum in Cleveland. The topic: improving 
patient care. Though we have long been involved in improving the 
quality of care provided in the nation's hospitals, we came away from 
that particular meeting with a strong sense from hospital leaders that, 
on a national level, we could do more--we needed to address these 
issues head on.
    But the issue of medical error is very broad in scope. We set our 
sights specifically on improving medication safety--reducing and 
preventing medication errors that result from things like different 
drugs being packaged in similar containers, use of confusing 
abbreviations on labels and prescriptions, illegible doctor 
handwriting, and more.
    Against the backdrop of all this activity came the IOM report, 
which led overnight to increased awareness of the importance and 
seriousness of this issue. The release of the report came as we were 
preparing to kick off our initiative to take a comprehensive look at 
hospitals' ability to prevent medication errors and help them make 
improvements where needed.
    As part of our initiative, we formed a partnership with a highly 
respected organization in this field, the Institute for Safe Medication 
Practices (ISMP). This non-profit research and education organization 
is dedicated to reducing the incidence of medication error throughout 
the health care system, and will provide leadership and technical 
expertise for the AHA's initiative.
    ISMP provides independent review of errors reported through the 
Medication Errors Reporting Program (MERP), which ISMP was instrumental 
in founding. Through MERP, health care professionals across the nation 
voluntarily complete pre-addressed mailers or dial a toll-free number 
(800-23-ERROR) to report actual and potential medication errors with 
complete confidentiality. As an official MedWatch partner, ISMP shares 
all information and prevention ideas with the U.S. Food and Drug 
Administration (FDA) and other professional and policy organizations. 
Working with practitioners, regulatory agencies, health care 
institutions, professional organizations, and the pharmaceutical 
industry, ISMP provides timely and accurate medication safety 
information and works toward improvements in drug distribution, naming, 
packaging, labeling, and delivery system design.
    The following four objectives are key to our medication safety 
campaign with ISMP.
Develop a non-punitive process for discussing errors
    Most of what has been learned in recent years about how to reduce 
errors and increase patient safety is based on two principles. First, 
individuals, by the very nature of being human, are vulnerable to 
error. Although they are the focus of the error, errors happen because 
of the systems in which these individuals work. As a result, reducing 
errors will require us to design and implement more error-resistant 
systems.
    Second, we have to create an environment in which we learn from 
failure. This requires us to identify an effective mechanism for candid 
discussion of errors. This cannot be achieved in an environment of 
punishment or fear. Doctors, nurses and other caregivers should not be 
penalized for stepping forward after an unfortunate mistake is made. A 
more open environment can only occur when health care providers are 
afforded adequate legal protections.
    Today, when health care providers are required to disclose 
confidential internal information to health care oversight agencies, 
they may jeopardize state law that protects internal quality analysis 
discussions and expose themselves to crushing legal liabilities. There 
is no incentive to share this information with others to prevent 
similar events in other institutions. We believe protections that 
currently apply to such information should also apply when it's 
disclosed. We believe that evidentiary, confidentiality and other legal 
reforms should be considered to help foster an evironment that promotes 
candor.
    Candor is absolutely critical if we are to be truly successful in 
identifying, learning from and reducing not only medication errors, but 
all medical errors, and making the health care system safer. We need to 
create a non-punitive culture at all levels that supports the 
collection of information about errors, along with candid discussion of 
errors, their causes, and ways to prevent them from happening again. A 
safe, non-punitive environment will encourage people to report and 
discuss errors--the first step in lessening the chance they will happen 
in the first place and making sure they do not happen again.
Share successful practices with every hospital and health system
    We sent to every AHA member the attached ``Quality Advisory on 
Improving Medication Safety.'' The advisory includes background on the 
issue, a long list of resources our members can turn to for help, and a 
three-page list of ``successful practices'' for improving medication 
safety. Some of these practices can be adopted easily and quickly, such 
as providing staff with information about ordering, dispensing, 
administering and monitoring medications, not storing certain 
concentrated solutions on hospital wards, and helping patients better 
understand what they are talking, why, and how to use it safely.
    Others are longer-term practices that, with time and money, can 
create significant changes throughout our members' organizations. Among 
these are the development of a voluntary, non-punitive system to 
monitor and report errors that might occur within hospitals, and the 
computerization of medication administration systems.
    We compiled the list of successful practices with the help and 
advice of some of the best experts in the field--including the ISMP, 
the Institute for Healthcare Improvement, the Massachusetts Coalition 
for the Prevention of Medical Errors, the National Coordinating Council 
for Medication Error Reporting and Prevention, the National Patient 
Safety Partnership and many others.
Develop a ``medication safety awareness test'' for use by hospitals
    To follow up on how the successful practices are being implemented, 
we are working with ISMP to develop a ``Medication Safety Awareness 
Test'' to help our members assess their progress. This tool will also 
help the AHA get an idea of what other help its members may need, and 
help us track and demonstrate hospitals' success at improving 
medication safety.
Serve as a clearinghouse of information and resources for hospitals
    The AHA will continue making available to its members up-to-date 
information on improving medication safety. We will gather information 
from outside sources and work with other national organizations to 
develop information and data. We are planning a medication safety 
``summit,'' gathering other organizations and hospital leaders together 
to discuss widespread efforts to improve medication safety. And we will 
be adding to our Web site (www.aha.org) a special area containing all 
the information, data, best practices, and other resources we compile 
in our medication safety improvement campaign.
                               conclusion
    Mr. Chairman, the IOM report is very timely. It comes as America's 
health care system enters a new century of caring for people. It marks 
an opportunity for us to rebuild the public's confidence and trust in 
the health care system they rely on every day. And it reminds us that, 
despite setbacks, we still deliver the greatest health care in the 
world.
    But it also notes that ``large, complex problems require 
thoughtful, multifaceted responses.'' Reducing and preventing 
medication errors, and improving the overall safety of the health care 
system, will demand the thoughtful collaboration and participation of 
everyone involved in the health care field: hospital leaders, 
pharmacists, drug manufacturers, doctors, nurses, government agencies, 
other organizations, and consumers. America's hospitals and health 
systems are committed to this effort.

    Mr. Bilirakis. Thank you very much, Doctor. Ms. Foley.

                     STATEMENT OF MARY FOLEY

    Ms. Foley. Thank you. I want to first start to take a 
moment to mention committee member, Congresswoman Lois Capps, 
who could not be here with us today because of the death in her 
family. I just recently had the opportunity to meet with the 
Congresswoman and we discussed a number of nursing issues. We 
did talk about the IOM report and the medical errors issue as 
it relates to nurses and she has indicated a strong interest in 
investigating the faulty systems in place that often result in 
medical errors. The ANA appreciates the work that Congresswoman 
Capps is doing in this area and looks forward to continuing 
this important discussion with her.
    My name is Mary Foley and I am President of the American 
Nurses Association. I am also the former Director of Nursing, 
Chief Nurse Executive at St. Francis Memorial Hospital in San 
Francisco, California. The ANA appreciates the opportunity 
today to discuss patient safety and medical errors. And it is 
an issue of great importance to us, one that is not missed by 
the front line healthcare workers who I describe as the patient 
and safety monitors on a 24-hour a day basis.
    ANA is the only full service professional organization 
representing the Nation's 2.6 million registered nurses and our 
membership includes staff nurses, nurse practitioners, clinical 
nurse specialists, nurse midwives, registered nurse 
anesthetists and nurse administrators and educators as well. We 
have been very pleased with the release of the report by the 
Institute of Medicine, problems that they have identified as 
not new to the registered nurse population or to ANA and we 
have long recognized these problems and have worked to address 
issues related to nursing care that enhanced patient safety and 
outcomes for many years.
    We are encouraged by the release of this report in the 
effort to spur public dialog and reach consensus on solutions 
to these pressing issues. As has been stated, 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 full strength drugs, even though they are toxic 
and less 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 healthcare 
system often lacks adequate coordination and appropriate 
systems to insure patient safety. 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 or even take time to read the chart to find 
that information out.
    Despite increasing evidence the systems fail. Institutions 
are continuing to assign and emphasize individual blame for 
errors, misjudgments and patient dissatisfaction. Hospital 
systems and administrators are assuming that the appropriate 
way to deal, and I know not all of us do this or did that, that 
the most 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 healthcare 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 the patients the severity 
of discipline applied to individual providers for mistakes is 
increasing. Healthcare organizations must approach problem-
solving strategies through shared accountability and 
partnerships.
    ANA supports many of the IOM study recommendations 
including the creation of a center for patient safety. Such a 
center 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 and we support 
this entity and we believe it must include adequate 
representation by nurses and other healthcare professionals who 
are the front line providers.
    The center must support research to determine what leads to 
errors. Specifically, they must be charged with collecting data 
on organizational practices and other factors that may be 
associated with the occurrence in errors. In our current 
knowledge, no one can state with certainty what practices could 
or more likely lead to errors. Some practices are more obvious 
than others. ANA has voiced criticism, however, of the report 
for its lack of attention to the staffing component of the 
issues. We in 1994 initiated at the ANA a quality of safety 
initiative and we have been collecting data about the 
relationship between the outcome of patient care in relation to 
the number of nurses and the number of patients.
    Inadequate or inappropriate staffing may mean too few 
registered nurses, a lack of appropriate training or 
orientation for an RN assigned to a unit or the inappropriate 
use of unlicensed assisted personnel. Adequate numbers of staff 
are necessary to reach a safe level of patient care services. 
Ongoing evaluation and benchmarking related to staffing are 
necessary elements in the provision of quality care. At a 
minimum, the center for patient safety should collect data 
related to the average ratio of patients to registered nurses 
and licensed nurses and the unlicensed personnel load, measures 
which differentiate between the 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 
healthcare errors.
    Mr. Bilirakis. Please summarize, Ms. Foley, if you would.
    Ms. Foley. Sure. Thank you. I think you have identified a 
major theme in our statement that while there is certainly 
great merit in the Institute of Medicine report, I have 
appreciated the many comments of the members today who 
recognize that the relationship between the workload, the 
opportunity for a professional, in our case for the nurse, to 
be truly responsible may have a resource relationship in terms 
of the number of staff, their preparation, and their ability to 
be attentive to the professional duty and to be the patient 
advocate that we want to be.
    So we really look forward to working with these committees. 
It was a wonderful event to see them come together today. And 
we appreciate the opportunity to be at the table and to speak 
in support of those elements that we find would help patient 
care and identify areas for improvement in the report.
    [The prepared statement of Mary Foley follows:]
     Prepared Statement of Mary Foley, President, American Nurses 
                              Association
    The American Nurses Association (ANA) appreciates the opportunity 
to discuss 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 errors. ANA is the only full-
service professional organization representing the nation's 2.6 million 
registered nurses, including staff nurses, nurse practitioners, 
clinical nurse specialists, certified nurse midwives and certified 
registered nurse anesthetists through its 53 state and territorial 
nurses associations.
    To Err is Human: Building a Safer Health System To Err is Human 
(IOM, December 1999) describes a fragmented health care system that is 
prone to errors and detrimental to safe patient care. This problem is 
not new to registered nurses and the American Nurses Association (ANA). 
ANA has long recognized this problem and has worked to address issues 
related to nursing care that enhance patient safety and outcomes for 
many years. We are encouraged, however, by the release of this report 
in an effort to spur public dialogue and reach consensus on solutions 
to these pressing issues.
    The human cost of medical errors is high. Based on the findings of 
one major study, medical errors kill some 44,000 people in U.S. 
hospitals each year. Another study puts the number much higher, at 
98,000. Even using the lower estimate, more people die from medical 
mistakes each year than from highway accidents, breast cancer, or AIDS. 
Moreover, while errors may be more easily detected in hospitals, they 
affect every health care setting: day-surgery and outpatient clinics, 
retail pharmacies, nursing homes, as well as home care. Deaths from 
medication errors take place both in and out of hospital settings--more 
than 7,000 annually--exceeding those from workplace injuries.
    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. 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.
    Despite increasing evidence that systems fail, institutions are 
continuing to assign and emphasize individual ``blame'' for errors, 
misjudgments 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. For example, in a 1996 Colorado case, medication errors 
were no longer treated as the domain of the hospital and the state 
licensing board, but drew the attention of the media and the court 
systems. Three registered nurses were charged with criminally negligent 
homicide when a medication error resulted in the death of a child 
(``Colorado Case Blurs Line'', 1997). Although criminal prosecution for 
medication errors is not a common practice, the fact that such cases 
exist point to the adherence to promoting a culture of individual 
blame. 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.
    Specific recommendations of the IOM report follow with ANA's 
response to each recommendation:

4.1 IOM recommends that Congress should create a Center for Patient 
        Safety within the Agency for Health Care Research and Quality. 
        The Center should: 1) set the national goals for patient 
        safety, track progress in meeting those goals, and issue an 
        annual report to the President and Congress on patient safety; 
        and 2) develop knowledge and understanding of errors in health 
        care by developing a research agenda, funding Centers for 
        Excellence, evaluation methods for identifying and preventing 
        errors, and funding dissemination and communication activities 
        to improve patient safety.ANA supports the creation of a Center 
        for Patient Safety as an oversight body to advance standards, 
        policies and actions related to reducing health care error. 
        Such a center 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 Center must support research to determine what factors lead to 
errors. Specifically, the Center 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 
causal factors that may contribute to health care errors may not be as 
apparent. For example, the IOM report lacks important information on 
the relationship between system errors and appropriate nurse staffing. 
In fact, ANA has voiced criticism of the report due to its inadequate 
attention to the staffing component of this issue.
    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 
Center for Patient Safety 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 Center for Patient Safety should examine the 
relationship between the errors 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 for a substitute for adequate 
supply of staff.
    The vital importance of registered nurses at the bedside, is a 
critical piece in preventing medication errors. The registered nurse at 
the patient's bedside is the patient's safety net. ANA agrees with the 
study's recommendation that health care organizations should implement 
proven medication safety procedures. However, an area of inadequate 
staffing that needs to be addressed in this recommendation, is the 
inappropriate use of unlicensed assistive personnel, UAP. The role of 
the UAP is important. The UAP assists the registered nurse, not provide 
nursing duties that are within an RN's scope of practice. More health 
care facilities, especially state facilities are increasingly relying 
on UAP's to administer medications.Currently, a number of states have 
legalized medication administration by unlicensed personnel in state 
institutions and subacute. For example, the Commonwealth of 
Massachusetts General Law Chapter 94C,7g authorizes unlicensed 
personnel to administer medication to patients within the Departments 
of Mental Retardation and Mental Health. The oversight of a registered 
nurses is not mandated by the state. The Massachusetts Nurses 
Association has been battling with the Massachusetts state legislature 
for many years regarding this issue. Financial cost appears to be the 
reason the Commonwealth does not raise the standard of care for their 
most vulnerable patients. Massachusetts is not the only state that 
relies on UAP's to administer medications, New York, Maine, Illinois 
and others have similar laws. ANA recommends that the Center of Patient 
Safety review the inappropriate use of UAP's administering medications 
in each state. Another area where the administration of medication by 
unlicensed individuals is increasing is in schools. In 1996, there were 
approximately 45,000 school nurses, mostly part-time for 87,125 school 
buildings and millions of school children. Due to the low number of 
school nurses working in the school systems, many students receive 
their medication from school administrators.

5.1/5.2 IOM recommends that a mandatory reporting system should be 
        established that provides for the collection of standardized 
        information by state governments about adverse events that 
        result in death or serious harm. Reporting should initially be 
        required of hospitals and eventually be required of other 
        institutional and ambulatory care settings.
    ANA supports the IOM's proposal that errors which lead to death or 
serious injury be the subject of mandatory reporting as an initial step 
in formalizing this system. In the long term, such mandatory reporting 
should include additional data beyond the sentinel events. ANA believes 
it is critical to evolve a comprehensive system of mandatory reporting 
to ensure that all factors in a system can be studied and assessed. 
What differentiates a fatal error from a minor error may be luck or 
chance. From a system's perspective, it is critical to understand the 
causal factors in any error in order to analyze them and prevent them 
in the future--whether that error resulted in an easily remedied 
situation or whether that error resulted in death. ANA agrees that it 
makes sense to start the operations of any mandatory system at one 
level of reporting, but the Congress must examine and direct how 
quickly a more comprehensive approach can be implemented.
    Whether reporting is mandatory or voluntary, there must be 
provisions that protect a nurse's right to speak out about activities 
and/or practices that threaten the health and safety of patients.

6.1 IOM recommends that Congress should pass legislation to extend peer 
        review protection 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.
    ANA understands the rationale for making this recommendation and 
some form of limited immunity may be appropriate in some instances. We 
are concerned, however, that any immunity be tailored narrowly enough 
to ensure that it helps attain the goal of patient safety, but doesn't 
provide a means for hospitals to hide or escape their accountability in 
health care errors.

7.1 IOM recommends that performance standards and expectations for 
        health care organizations (regulators/accreditors and public/
        private purchasers) should focus greater attention on patient 
        safety.
    ANA strongly supports the establishment of performance standards 
and expectations for health care organizations. In particular, ANA 
supports systems for evaluating the impact of reorganization efforts on 
patient care, the overall patient care environment and the ability of 
health care providers to continue to practice in safety.

7.2 IOM recommends that performance standards and expectations for 
        health professionals should focus greater attention on patient 
        safety.
    ANA long advocated for continuous education of health care 
professionals on patient safety issues as well as assuring that 
registered nurses stay current in their practice as approaches that can 
help reduce errors and promote patient safety. Toward this end, we have 
supported and worked on approaches to measuring continuing competence 
of registered nurses that would meet this goal. We do not see how the 
IOM proposal for relicensure contributes to measuring the competence of 
professionals since so many professionals practice within speciality 
areas and periodic relicensing does not assure measure of continuing 
competency in one's speciality field. Relicensure is one approach to 
many approaches to measuring continuing competency that has been 
discussed. It is premature and unhelpful to identify that as the only 
approach to be promoted as an overall effort to reduce error.
    The American Nurses Credentialing Center (ANCC) recently released 
an international survey of certified registered nurses in the U.S. and 
Canada. A statistical significant portion of the survey respondents 
reported that certification enabled their surveillance and early 
intervention practices--thereby reducing health care error. The 
competence of health care providers is an important issue, but ANA 
would support a variety of approaches to this issue.

7.3 IOM recommends that the Food and Drug Administration should 
        increase attention to the safe use of drugs in both pre- and 
        post-marketing processes.
    ANA supports this recommendation. ANA has long supported safer 
manufacturing and distribution of drugs, medical devices, and 
equipment. Through participation in the National Patient Safety 
Partnership Initiative for Preventing Adverse Drug Events earlier this 
year, nurses spoke for these specific issues and took part in 
developing and disseminating best practice recommendations and consumer 
guidelines.

8.1 IOM recommends that health care organizations and the professionals 
        affiliated with them should make continually improved patient 
        safety programs with defined executive responsibility.
    ANA strongly supports any effort that makes patient safety a 
coordinated focused effort 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.

8.2 Health care organizations should implement proven medication safety 
        practices.
    ANA supports the implementation of medication safety practices that 
are based on sound science and evaluation of those practices. Such 
improvements should be public information and reach to the core or root 
cause, not merely be a band-aid approach. For example, having a 
pharmacist accompany a nurse at medication administration time is not 
the answer if in fact there is only one nurse for 15 patients and he/
she has 2 admissions and 3 discharges at medication time. There are 
other factors that must be accounted for such as appropriate staffing 
in this recommendation.
    ANA thanks the Committee for sponsoring these hearings on such a 
critical issue in the health care delivery system today. ANA believes 
through a variety of strategies and collaboration that we can address 
this important issue in today's health care system.

    Mr. Bilirakis. Thank you very much, Ms. Foley. Let me just 
start off with you. You didn't mention this in your oral 
remarks. If I read your testimony right, you acknowledge the 
need for some form of limited immunity. If you did mention it 
in your oral remarks I missed it but, in any case do you 
acknowledge that, the need for some form of limited immunity to 
encourage healthcare organizations to participate in voluntary 
reporting and reduction systems?
    Ms. Foley. I did not mention it in the oral remarks. If you 
are asking a question related to the lack of blame or 
discipline for the individual practitioner, we certainly 
support that. And in a blame environment folks are not going to 
be coming forward. The question was asked earlier how do people 
find out about errors. A nurse coming on to the next shift may 
walk in the room and find the inappropriate intravenous bag 
hanging, wrong patient name, wrong drug, wrong mixture of 
medication. The individual making that report would be very 
troubled by that. Perhaps they may be pointing blame at their 
prior co-worker. They, however, could be assisting in solving a 
problem in the future. Perhaps it was a pharmacy error or a 
delivery error. So I do believe that ANA does support certainly 
for the individual provider----
    Mr. Bilirakis. In the illustration you mentioned, to whom 
would that immunity apply, which nurse?
    Ms. Foley. Well, certainly the individual wishing to make 
the report that they had a finding, that there had been an 
error that had occurred. In this case that person would really 
be a party to making an improvement and I think we would have 
to look at the system that allowed the error to happen in the 
first place.
    Mr. Bilirakis. You are pretty clear in that regard.
    Ms. Foley. Without applying blame or individual 
responsibility. We are certainly aware that healthcare 
professionals have to be responsible for their practice, and 
they wish to be and they wish to be accountable for their 
practice. And I think we are struggling as an association to 
define where the liability and the protections for that go 
while we still want to promote the reporting. So I am not sure 
I have the definitive answer today.
    Mr. Bilirakis. You don't have an idea of what you may mean 
by limited immunity, what sort of limited immunity----
    Ms. Foley. No, I think limited is open to definition.
    Mr. Bilirakis. You are limited in terms of----
    Ms. Foley. And we look forward to participating more in 
that discussion among our own association members.
    Mr. Bilirakis. Thank you Dr. Langberg. I appreciate your 
testimony, of course, and the depth of your experience as a 
physician practicing in a large urban hospital system. On page 
7 of your written testimony, and you talked about this, you 
said confidentiality and other legal reforms, tort reform and 
liability in any case, should be considered to help foster an 
environment that promotes candor in reporting medical errors.
    Ms. Foley mentioned limited immunity, which I guess is 
consistent with what I understood you to mean. What specific 
kinds of legal reforms do you think would be useful in this 
context?
    Mr. Langberg. I think from the AHA's perspective the key 
point that we are trying to identify is creating an atmosphere 
that will promote the reporting of events and not be punitive. 
The experience we have had both as has been reported, and I can 
speak specifically in my institution has been that the more 
people fear either legal or job-related consequences the more 
they are unlikely to report. The more they are unlikely to 
report, we ultimately don't know and we can't ultimately 
identify solutions to problems.
    So at this point I would have to say that the nature of the 
kind of immunity or protection we are speaking about from a 
legal point of view, I will defer getting into specific detail 
on. I think the key is no matter what we ultimately create as 
far as any kind of reporting obligations that we make sure to 
encourage rather than inhibit.
    Mr. Bilirakis. Yes, and that is good and that is of course 
what Ms. Foley's point was too. But you would throw it upon the 
shoulders of Congress then to determine what those protections 
should be and without any suggestions as to what they may be. 
And then no matter what we come up with it would probably be 
criticized in one way or another. This is why I ask those 
questions.
    If you have any ideas--whether you want to state them today 
or whether you want to do it in writing, please submit them.
    Mr. Langberg. I will be happy to respond in writing after 
today's hearing. I would point out that there are existing 
protections. I know in California there are protections for 
peer review, confidentiality, and there are also Federal 
protections in that regard. I think those are examples of the 
kind of protections that we have experienced as having a great 
support for the disclosures that people in professional 
capacities can give.
    As far as your comment on putting it at the feet of 
Congress, I think that we in the AHA and among the colleagues 
you have heard today probably have different opinions about 
ways to go about this particular question of immunity or 
disclosability reporting. I think what I would encourage is an 
opportunity for Congress to hear inclusive of the different 
perspectives we all represent.
    Mr. Bilirakis. Yes, I don't think we have done very much in 
the area of healthcare that the American Hospital Association 
and all of the other healthcare organizations have not been a 
part of. Mr. Barrett.
    Mr. Barrett. Thank you, Mr. Chairman. Ms. Foley, under the 
current system nurses are required to report certain events 
like needle stick injuries but from what I understand often 
times even these injuries are not reported. What is your 
analysis, what is the reason for that?
    Ms. Foley. In part, fear of discipline and claims, very 
wild claims unfortunately. We have had nurses who had an 
accidental needle stick and actually have been accused of self 
inflicting it for retribution against their facility. We have 
had some really outrageous stories of what I would call the 
worst of practices in the environments, not the best of 
practices by any means. There is a concern that once the report 
is there that there was a magic number back in the early 
nursing days, you know, three medication errors and you would 
be out.
    There is usually no such hard and fast rule but those 
beliefs exist in people's minds and in some environments 
unfortunately they are trying very actively to discourage 
mistakes in such a way that it discourages the reporting.
    Mr. Barrett. I guess the needle stick one sort of sticks in 
my mind more than any one, no pun intended. Because I see two 
powerful incentives for the nurse to report it. First, 
obviously if there was any type of exposure to hepatitis C or 
HIV just for medical reasons alone to do it. And, second, if 
ultimately there is going to be any sort of disability dispute 
not having a record I think would make it more difficult for 
the nurse to get payments and so to me it sort of brings in the 
question of how if in a situation where you have the two most 
powerful incentives for a person to self report, you are still 
not getting it. I wonder how effective ultimately this is going 
to be.
    Ms. Foley. I believe if the system approach is used and 
institutions and our industries are encouraged to participate 
in a meaningful way that there would be an atmosphere in which 
there would be trust and the culture of reporting and the 
culture of supportive changes. You know, when someone has a 
needle stick it may be because the equipment is flawed. It may 
have nothing to do with personal use practices. And 
unfortunately we are still as we find in a lot of working 
industries, there is a blame the victim, blame the worker, they 
must have made the mistake, they must have done something 
wrong.
    I work on a program where we recreate the scenarios in 
which injections are given and we try to create every 
impossibility to do it safely when we are testing new products 
because we want to find out is that product going to help you 
when your hands are slippery with blood or the lights are dim 
or the table is moving or the ambulance is rocking down the 
hill. Some of those opportunities to test devices and do a 
system approach for the improvement would take away the blame 
that if an injury occurred perhaps you better look at why it 
occurred and not at the person as the result or as the problem.
    Mr. Barrett. We have had a little bit of a love fest here 
today in regards to the VA and the reporting system that they 
have, and that is good. But if you look at the VA, its 
structure isn't necessarily like the structure of hospitals or 
healthcare providers outside of that setting. Obviously there 
is more control, more authority in the VA system. Dr. Langberg, 
what would we need to have in place outside of the VA system to 
have an effective system?
    Mr. Langberg. The experience that we have had at Cedars-
Sinai really relates directly to the work that the Joint 
Commission has done, a sentinel event on the sentinel event 
policy, and I want to actually publicly acknowledge Dr. O'Leary 
for his leadership in creating that process. Over the last 
couple of years we have assiduously developed a program to get 
individuals to report things that they see, whether they are 
sentinel events as defined by the Joint Commission or near 
misses. We define that collection of things as significant 
adverse events.
    Whether or not they know it to be true as long as they 
think it might be true, we have developed a policy and a 
practice to do that. Our original experience at the beginning 
of this was that few reports were made and as we developed 
education educating all the staff and all the physicians in the 
institution, we found that there was almost a geometric 
increase in reports. I would say at least half of those reports 
upon preliminary evaluation are not close to being a 
significant adverse event but a good proportion of them were 
and we were able to use a root cause analysis methodology again 
that was originally proposed by the Joint Commission to learn 
from those.
    The experience we have, in answer to your question, is that 
it take a culture change within an institution to encourage 
people to report and to make them believe that if they report 
not only will they not suffer consequences but that the 
information will actually be used to improve taking care of 
patients in the institution. Culture is not an on or off 
experience. It is not a switch one can throw that you have it 
tomorrow when you don't have it today. It takes time. It takes 
education. It takes consistent behavior on the part of 
management and employees and physicians and it takes education 
and commitment. And that has been in our experience the keys to 
the solution.
    Mr. Barrett. Thank you, and thank you, Mr. Chairman.
    Mr. Bilirakis. Thank you. Chairman Stearns.
    Mr. Stearns. Thank you, Mr. Chairman. Dr. O'Leary, what are 
the critical elements of an effective reporting system?
    Mr. O'Leary. I think the critical elements of a good 
reporting system are first of all to define what is to be 
reported very crisply so that we are going to get a clear drop 
of the things that are really important and not a lot of wheat 
and shaft. The numbers we are dealing with are huge potentially 
and we need to be able to focus on the critical elements. 
Second, as I think has been emphasized here, we have to have a 
requirement for root cause analyses. The reporting of the 
events themselves does not give you the information you need to 
solve problems. The root cause analyses are where the action 
really lies.
    Third, we have to protect the confidentiality of the 
reported information or we are simply not going to get it. I 
would be happy to elaborate on that further but that is a 
critical element, and I think that has to be provided not in 
the rubric of tort reform but under the rubric of peer review 
protection statute, something that we have in most of the 
States in the country but which are very uneven. Some are 
strong and some are very weak and we need something uniform, I 
would say, from the Federal level.
    Fourthly, we need data sharing amongst all responsible 
parties to say that there are a lot of different players in 
this system. Not all hospitals or all health provider 
organizations in this country are accredited by the Joint 
Commission. We are a major player but there are other major 
players as well. And, finally, we have to be able to 
disseminate lessons learned and best practices across the 
delivery system. We have to harvest the information we glean 
out of our root cause analyses.
    Mr. Stearns. Anyone else on the panel, when Dr. Cousins 
talked about the public would be better served by a hospital 
report card which focused on a facility's adoption of a set of 
best practices rather than by an error score card, anyone else 
on the panel that would like to give comments to that prior 
testimony? Yes. Dr. Golden.
    Mr. Golden. The experience that I have had working with 
hospitals in my state, there is--report cards have limitations 
on adverse events because they are often dealing with small 
numbers and you can have unfortunate implications from very 
small numbers. On the other hand, we work with the institutions 
in our State to assess how they are responding to our projects 
and how they implement them. And so we right now are 
essentially giving hospitals in our State in a way a report 
card of their ability to implement quality improvement.
    And they have been very responsive to that and have been 
very interested in assessing how they are responding to the 
challenge of clinically pertinent data to improve their 
processes and it has been very successful. We have had about 35 
projects in that area and many QIOs are doing similar kinds of 
activities.
    Ms. Foley. Part of the nursing quality and safety 
initiative was to develop a nursing care report card. We have 
activities now in six States and we are really going to be 
working closely with the Hospital Association in some future 
dialog to try to expand the project. It does measure our nurse 
sensitive indicators that we have shown through research that a 
patient's effect will change dependent on the relationship of 
adequate numbers of nurses. Pain management is a very clear 
example. When there isn't adequate staff the pain is usually 
not assessed and treated appropriately and quickly.
    Falls is another indication perhaps that there isn't 
adequate observation of an individual's risk for injury. And so 
we have identified the nursing care report card elements as an 
opportunity for consumer judgment of a facility based on 
staffing and some of the outcomes that they will experience as 
patients or that their family would experience.
    Mr. Stearns. Dr. O'Leary, if you or I, or you or Chairman 
Bilirakis, you were a Member of Congress, and after this 
hearing--were you here on the two prior panels, did you hear 
them?
    Mr. O'Leary. Yes, I did.
    Mr. Stearns. What would you do in terms of a piece of 
legislation? Do you think a piece of legislation is required? 
Do you think we could legislate something here out of the 
Commerce Committee or out of the Veterans--not out of the 
Veterans but out of the Commerce, Mr. Bilirakis' committee, we 
could legislate something here in terms of a national safety 
center or in terms of a report card. What is your feeling?
    Mr. O'Leary. Well, if I get one bite of the apple it is the 
Federal protection for the reported information. Quite frankly, 
I don't believe that any of the recommendations in the IOM 
report can be meaningfully implemented without that kind of 
protection. We have to create--we have to force a safe 
environment for surfacing these problems and be able to, as Dr. 
Langberg has said, talk about them, talk about them inside our 
organizations, talk about them with responsible oversight 
bodies, harvest information, share that information.
    This is not like airplane crashes. These crashes occur one 
at a time. They are well hidden in our organizations. If you do 
the math, let us say there are 60,000 deaths a year and there 
are 6,000 hospitals. That is 10 crashes a year. If you talked 
to any hospital CEO in this country, I will bet you not one of 
them will tell you that they know of ten sentinel events in 
their organization in the past year and I believe them because 
this information is not even getting up inside organizations.
    We have to create a very different environment and culture 
change has to happen but it is going to take a long time and I 
think we need to create a statutory framework that fosters that 
kind of culture change. Downstream I think we can talk about 
mandatory reporting systems. We can talk about public reporting 
but you have got to gain the confidence of providers that it is 
safe to talk about and safe to surface this information or it 
is simply not going to happen.
    Mr. Langberg. Could I make a comment?
    Mr. Stearns. Yes, certainly.
    Mr. Langberg. I just wanted to comment that right now 
without legislation that environment exists.
    Mr. Stearns. So you don't think we need legislation.
    Mr. Langberg. Well, I am saying that right now we can do a 
lot of what Dr. O'Leary has outlined right now through the QIO 
system because that confidentiality now exists with the QIOs at 
the State level. And so many of the things that we have been 
talking about in similar testimony about the need to measure, 
the need to report and need to disseminate best practices can 
be done now in a confidential environment through working with 
the QIO system.
    Mr. O'Leary. If I might, I don't think that is actually 
clear where a hospital reports that information to you. The 
information you have may be protected but they may have waived 
their confidentiality protections. I don't think that has been 
tested actually.
    Mr. Stearns. Well, very quickly, sir. We don't want to get 
into----
    Mr. Golden. It is our understanding that it was tested in a 
case in Tennessee a few years back and it does have protection.
    Mr. Bilirakis. Mr. Green.
    Mr. Green. Thank you, Mr. Chairman. I have a number of 
questions and I know I will run out of my 5 minutes. Ms. Foley, 
the Joint Commission's definition of a sentinel event includes 
some very serious errors, surgery on the wrong body part, 
abduction of an infant, a rape of a patient. Don't you think 
these type of serious adverse events should be subject to a 
mandatory public reporting system?
    Ms. Foley. They certainly rise to the level of severity and 
probably merit stronger encouragement, perhaps mandatory. They 
are the most of the severe of the severe. I mean I support what 
the Sentinel Event Program has accomplished and did participate 
in a few root cause analyses myself as an administrator, but we 
also know that there are a lot of errors that occur well below 
the threshold of severe and permanent harm or death or rape or 
infant abduction that could be corrected in systems if we knew 
about them, talked about them, shared that information. So I 
don't want to evade the answer. I think we all need to figure 
out at some point there is a threshold from where it becomes so 
severe the potential for harm that there should be a mandatory 
nature.
    Mr. Green. Again, those that I mentioned obviously should 
rate a little higher above just inadvertent error. Dr. Golden, 
you mentioned in your testimony that reporting information 
regarding medical errors should be mandatory. Many of our 
witnesses have focused on the voluntary reporting, and why do 
you think it should be mandatory?
    Mr. Golden. The errors I am talking about now are adverse 
events, certain specific categories of, if you will, accidents. 
Those are the kinds of issues that were discussed by the IOM as 
often complex interactions that resulted in consequences and 
events that were not foreseen by the participants, and I think 
that those are often very rare and we can identify them in 
certain categories.
    And since they are fairly rare and sort of a random kind of 
process of system failures it is useful to report those so we 
can analyze them and allow institutions that hadn't seen that 
error yet to learn from that experience of others so we can 
raise the safety of the entire system and not just one or two 
institutions that have that error.
    Mr. Green. Do you think the idea is to get the data into a 
big system and run the analysis and then see what we find out, 
and the second approach is like that followed by the PROs where 
you go into the records and look at specific areas known to 
have problems and focus on improvement in those areas?
    Mr. Golden. I think that since some of these events are 
very small numbers and you have to go through lots of charts 
the mandatory reporting would help us identify those rare 
events. At the same time, we can focus on specific diseases and 
processes and through structured review find errors of omission 
and commission that basically can become disease focused sort 
of like Dr. Norwood said earlier about becoming focused on 
areas of improvement.
    So it is a combination of factors there, one for rare 
events and one for systematic evaluation of diseases and 
processes that can be high yield and then bring about 
improvement.
    Mr. Green. Can Congress focus on encouraging more of those 
focused studies like the PROs are doing and while we are still 
trying to understand how to create this large error data bank. 
Is there something we can do on a short-term basis?
    Mr. Golden. Yes, I think we can expand the current programs 
we have in place with the PROs. I think we can support AHRQ in 
terms of research to identify the performance measures. That is 
really what it comes down to. A lot of this is performance 
measurement, which we are very well adapted and many 
institutions now can do to get the data to look at the gaps and 
performance and then to educate and outreach.
    And that is the other piece of what many of us are doing 
now especially at the local level is to work with institutions, 
give them technical assistance to work with the data, and then 
improve what they are doing. That is the last piece to make a 
difference in performance in response to data.
    Mr. Green. Mr. Chairman, I have one other question of Ms. 
Foley here. Dr. Berwick, first on our panel and other experts 
in the study of medical errors, cite the need to develop best 
practice guidelines that are shown to reduce medical errors. At 
the moment there is already a good bit of information or 
knowledge about practices that can reduce medication errors. 
For example, physicians can electronically write prescriptions, 
hospitals can bar code medications. What is your opinion about 
such best practices for medication? How much are we going to 
help reduce medical errors by those using the technology we 
have heard from other panels?
    Ms. Foley. I think it would be a tremendous asset and there 
have been a few demonstrations. I know some institutions have 
implemented pieces of this. I would support it wholeheartedly 
and be very realistic in saying that that will take a resource 
allocation both in terms of the research and development of the 
best devices and the mechanisms that would be supportive of 
that and then for the institutions to be able to bring that 
into their system and get that up and running there would also 
be an accompanying cost but it would be an incredible step 
forward.
    Illegible handwriting, there is no secret that that is a 
major problem in our system and the number of people who have 
to read, interpret and touch a prescription and order from the 
point it is ordered to the point it is administered is a chain 
of individuals who wish to be very responsible, and the more 
the systems can support their care the better the outcome will 
be. I think it would be a major reduction in those types of 
mistakes, not always that end up in the most adverse event but 
they can lead to them and they certainly count as the errors 
that we know are frequent.
    Mr. Green. How would that compare to the concerns about 
staffing shortages?
    Ms. Foley. Well, I think we need to do both. Very 
seriously.
    Mr. Bilirakis. Dr. Ganske to inquire.
    Mr. Ganske. Thanks, Mr. Chairman, and thanks to the panel. 
So much in so little time, I guess. I guess I should start by 
saying, Mr. Chairman, that I think we should have some 
additional information on the validity of the incidence of 
significant medical errors. And one way that we could do that 
within the existing structure would be to instruct the National 
Institutes of Health to look at this problem and to look at 
particular disease treatment regimens, follow them, look at 
them, because as I pointed out in my opening statement before, 
you have to be careful about attributing a result to an error 
when it could be the result of the disease or the natural 
progression particularly if you are dealing with very 
complicated patients with a lot of different illnesses.
    And there is a certain incidence, whatever is acceptable, 
regardless of how good your technique is. I would never claim 
to a patient that I was operating on that I had a 0 percent 
incidence of infection. I don't know how you can do that. So I 
think we need to look at very carefully how you define an 
error, the level of the error, and I think there is that 
expertise, for instance, at the NIH that we ought to look at.
    Second, I would make a point, I do not think that this 
debate on errors should lead to an opening of the national 
practitioner data bank. That practitioner data bank was set up 
for another reason. The data in that data bank did not 
necessarily indicate errors. Some of that data is related to 
settlements. And, you know, a practitioner, be it a nurse or a 
physician, may not have made that decision. That is an 
insurance company decision as to whether that settlement was 
made or not.
    In fact, the nurse or the doctor may feel very, very 
strongly that they want to take it to court because they know 
that they did not commit any malpractice. And yet it is 
reported in there as a settlement and if you would release that 
data the public wouldn't make that differentiation. I even 
heard some Members of Congress say that they think that this 
information ought to be posted on a doctor's office wall, for 
goodness sakes.
    I want to ask this panel, why don't we just go down the 
line, yes or no, do you think that the national practitioner's 
data bank should be open?
    Mr. Perry. I don't think that is the best way to do it but 
I do believe in public awareness at least at the institutional 
level of medical errors.
    Mr. O'Leary. No.
    Mr. Golden. A little bit longer. I talked to physicians. 
They are interested in improving care. They are fearful of data 
banks because of what could happen to the data, so I would say 
no.
    Mr. Langberg. No.
    Ms. Foley. And no.
    Mr. Ganske. Okay, so pretty much unanimous no. This is what 
my fear about some of what we are talking about and that is 
when we are talking about errors of omission or commission 
these are decisions that are frequently medical judgments. Let 
me give you an example and this is where you have to be very 
careful when you use best practice guidelines. I was a hand 
surgeon and I took care of thousands of finger fractures. The 
vast majority of those finger fractures I could treat with 
splinting, a closed reduction splinting, and you get a good 
result.
    But, you know, once in a while I might have a pianist come 
along or professional musician or a surgeon and instead of just 
getting 80 percent range of motion as your result you might 
need nearly normal range of motion. And so your decision, your 
judgment there might be to do an open reduction and an internal 
fixation type procedure. But when you are looking at best 
practice guidelines there is always inherently a value judgment 
that determines how you determine that and it almost always is 
on the basis of cost versus optimal outcome.
    And so I, for instance, might have taken care of a patient 
that needs that operation. Maybe that patient was that one 
patient out of 200 that gets an infection because they had a 
dirty finger open fracture. Somebody looks at that and now they 
say, oh, you know, you shouldn't have treated it that way. That 
is where I think we need to have some very sophisticated 
analysis and I think that goes along with what you were 
alluding to, Dr. O'Leary, when we look at this question.
    Two other things. Mr. Chairman, I am very glad we had this 
but you know what, if you really want to look at some egregious 
medical practices going on in this country, I would like to 
share with you some of the web sites on medical quackery. You 
would be amazed at what some people are being sold over the 
Internet as medical care and some of the really, really bad 
results that people are getting from unprofessional or really 
quack treatments. And this is something we ought to look at.
    Finally, I want to say this about HMOs as it relates to 
your comments, Ms. Foley. It was 6 months or 12 months ago that 
either on Nightline or Front Line or PBS, some such program, 
there was a documentary on the effect of HMOs in the system, 
and I will never forget the segment where they interviewed an 
RN who was in charge of a floor. Dr. Langberg, you are shaking 
your head like you know what I mean. And I am not bashing 
hospitals on this because I know that hospitals are under that 
gun.
    But this poor nurse just about--I think she broke down and 
cried on that interview about how frustrated she was with 
having to deal with the degree of medical complexity and being 
left with health aides. And they interviewed a health aide, 
what a good soul that lady was. She was doing her honest to God 
best to take care of patients and she just didn't have the 
training or the knowledge to do that.
    And I think, Mr. Chairman, we need to look at the effect of 
HMOs on the medical errors that are occurring around the 
country, especially as it relates to nursing staffing in 
hospitals.
    Mr. Bilirakis. I thank the gentleman. Dr. Snyder.
    Mr. Snyder. Thank you, Mr. Chairman. Dr. Golden, as the 
Arkansas representative here, I will aim my questions at you. 
This report that came out, there has been some discussion 
earlier today about how reliable we think the studies and the 
extrapolations were. Do you buy the numbers?
    Mr. Golden. I am not sure about the death rates, 
extrapolated death rates, but I looked at one of the studies, 
some of the data has not been published, but a study out of 
Utah and Colorado the other day, and they seemed reasonable. 
Certain percentages of the adverse events were deemed 
preventable or not preventable. And I thought the numbers in 
that paper and surgical literature was actually fairly 
reasonable.
    Mr. Snyder. Now if you all and the public and perhaps 
Congress and the State legislatures, if they are in the year 
2010 and we are looking back and saying, well, how are we 
doing, do we have any base line numbers out there that we are 
going to be able to tell over the next few years how we are 
doing?
    Mr. Golden. We are increasingly developing those base line 
numbers but I think as you heard earlier I think from Dr. 
Norwood, I think you have to base it on individual disease 
states and surgeries and processes, and we have those numbers 
now. On certain kind of catastrophic problems it is more random 
and I think we have a harder time getting those base line 
numbers but the more specific we ask the question the better we 
will have the base line. So those numbers are available now and 
we can get numbers to compare our progress. We sure can.
    Mr. Snyder. As opposed to kind of the whole system wide----
    Mr. Golden. Well, that is correct. I mean we know now the 
drug time for treatment of MIs, for acute thrombolysis. We know 
how many people are getting aspirin. We know when people are 
getting Ace inhibitors for their congestive heart failure. We 
know the rates of mammography use. We have those numbers and we 
can use those numbers to assess our progress.
    Mr. Snyder. The last question I wanted to ask you with UMS 
and Little Rock that is just a bridge away across the street to 
the VA hospital, and we have talked a lot about the VA today 
and the work that they are doing, what is happening in the 
medical school or the nursing school curriculum, what changes 
have you seen recently or do you foresee happening with regard 
to patient safety?
    Mr. Golden. There are a number of things. I taught physical 
diagnosis for years at UNS and Dr. Jeanie Hurd came along with 
me. She became now the dean of graduate medical education. She 
and I worked together on these issues specifically and in fact 
will be a member of the QIO board I think this summer. She 
developed a whole program called Objective Structured Clinical 
Examinations where students can't just get an easy path. They 
have to go in a room. They have a standardized patient, a 
standardized set of clinical circumstances, and they can't 
hide. Somebody is watching that exam. And schools all over the 
country are developing these things.
    It makes the students very nervous but if you go in a room 
and you ask the student, okay, here is a patient sitting there, 
tell me what you hear when you listen to the heart. They either 
hear the murmur or they don't. And you begin to get a sense of 
performance, of competency. The student gets immediate feedback 
of what they can or cannot do and that to me is a terrific 
improvement in medical education because it is a standardized 
event where the student either gets it or he doesn't or she 
doesn't and gets immediate feedback as to what they know and 
don't know.
    Mr. Snyder. That is a tremendous opportunity and I think we 
are going to have more and more education on these issues as 
well for quality improvement with the health staff. Thank you, 
Mr. Chairman.
    Mr. Bilirakis. I thank you, Dr. Snyder, and thank all the 
members of the subcommittee. We have been here for quite some 
time. Ms. Foley and gentlemen, thank you so very much for being 
here. I failed to make this point to the other panels, but I 
hope that any questions we may forward to you, you might 
respond to, if you would as soon as you possibly can. Thank you 
so much. Tough subject. I would like to think that you have 
helped us an awful lot in addressing it.
    [Whereupon, at 2:20 p.m., the subcommittees were 
adjourned.]
    [Additional material submitted for the record follows:]
  Prepared Statement of The American Osteopathic Association and The 
              American Osteopathic Healthcare Association
    This statement is presented on behalf of the American Osteopathic 
Association (AOA) and the American Osteopathic Healthcare Association 
(AOHA). The AOA represents the 44,000 osteopathic physicians throughout 
the United States who practice medicine and are committed to ensuring 
the highest standards of patient care. The AOA is the national 
professional organization for osteopathic physicians, and is the 
recognized accrediting authority for colleges of osteopathic medicine, 
osteopathic postdoctoral training programs and osteopathic continuing 
medical education. The AOHA represents the nation's hospitals and 
health systems that deliver osteopathic healthcare or osteopathic 
graduate medical education. Through a for-profit subsidiary, the AOHA 
provides its members with access to risk management assistance, among 
other products and services.
    Osteopathic medicine is one of two distinct branches of medical 
practice in the United States. While allopathic physicians (MDs) 
comprise the majority of the nation's physician workforce, osteopathic 
physicians (DOs) comprise more than five percent of the physicians who 
practice in the United States. Significantly, D.O.s represent more than 
15 percent of the physicians practicing in communities of less than 
10,000 and 18 percent of physicians serving communities of 2,500 or 
less.
    The AOA and the AOHA are deeply concerned about the frequency of 
adverse events cited by the Institute of Medicine in its recent study, 
``To Err is Human.'' The Institute reported that between 44,000 and 
98,000 patients died or were injured in 1984 and 1992 as a result of 
these adverse events.
    The members of the osteopathic medical profession have long 
supported efforts to improve patient care by drastically reducing 
medical errors. In 1945, the AOA's Healthcare Facilities Accreditation 
Program (HFAP) was established. The HFAP is authorized by the Health 
Care Financing Administration (HCFA) to accredit osteopathic and 
allopathic hospitals and healthcare systems for Medicare purposes. The 
HFAP assists hospitals and their staffs in reducing or eliminating 
medical errors by developing Quality Monitoring and Improvement 
programs that monitor patient safety. On January 27, the AOHA held its 
first seminar on improving patient safety and reducing medical errors. 
Additional seminars are planned for March 24, and will be held 
throughout the year.
    The AOA and AOHA generally support the IOM's recommendations to 
bolster nationwide efforts to improve patient safety. We support forums 
that explore ways in which healthcare organizations can participate in 
the effort to reduce medical errors. The healthcare community can, and 
should, expand current activities to identify and address system 
failures that lead to medical errors.
    The osteopathic medical community will continue its efforts to 
strengthen existing quality improvement activities at every level, 
including the education and training of medical professionals and 
administrative personnel. We do not believe that the way to improve 
healthcare is to increase federal mandates, regulation, and 
administrative burdens, which could suppress reporting and inhibit open 
discussion of adverse events and medical errors.
    The AOA and the AOHA agree with the IOM that it is important to 
have reliable information about adverse events that healthcare 
professionals can use to assess, analyze and correct systemic and other 
failures that lead to such events. There is potential for such 
information to enhance the understanding of medical errors, while 
preventing future errors. Unfortunately, there is scant proof among the 
approximately 20 states currently reporting such data that the 
healthcare systems are any safer in those states than in states that do 
not have such reporting.
    We do believe, however, that state medical error reporting programs 
already in place may offer models for a federal effort to compile 
similar data. These should be closely reviewed and considered before 
federal action is taken. For instance, the data now being collected 
should be analyzed to determine whether or not the data used in the IOM 
study is reflective of the current state of affairs. Additionally, 
consideration ought to be given to the development of pilot projects 
designed to collect adverse event data. Finally, federal agencies 
should use the data compiled by states with mandatory reporting 
programs to determine whether their data is comparable with the IOM's 
data, which may be outdated.
    Outdated data may have distorted the IOM's conclusions about the 
alleged epidemic of medical errors. Accurate data could help federal 
agencies determine which areas of healthcare experience the most errors 
and are most in need of restructuring. Accordingly, the AOA and AOHA 
would recommend a revised study using more current data than 1984 or 
1992 as reported by the IOM.
    Mandatory reporting of adverse events presents a number of serious 
problems. Healthcare facilities may be reluctant to cooperate with 
mandatory (or even voluntary) data reporting if they perceive that they 
will be disciplined. It will be difficult to learn from errors and to 
improve systems if facilities and individuals fear that the information 
will be used against them. Only after the IOM study and its supporting 
data have been analyzed fully and pilot projects established, should 
policymakers consider the establishment of a national database, with 
either voluntary or mandatory reporting.
    If a national effort to gather and analyze adverse event data goes 
forward, the information should not be solely available to federal 
healthcare agencies. Stripped of its identifiers, it also must be 
available to healthcare facilities, researchers, accreditation 
organizations, and other healthcare entities that, in turn, could use 
the data to benchmark and monitor changes in the occurrence of medical 
errors. In this way, the database would serve as a tool to promote 
higher standards of patient care. Healthcare facilities and providers 
who report and assess medical errors can attempt to rectify particular 
problems by monitoring their data and comparing it with federal, state 
and local trends. Identifiable data is not necessary for this function 
to be met.
    Identifiable data should not be available to the public because to 
do so would inhibit reporting due to a natural fear of punishment and 
litigation. Healthcare professions continuously work to correct medical 
errors. The AOA and the AOHA believe that the American healthcare 
system operates well on the whole. Public confidence in that system 
should not be undermined while healthcare providers seek to increase 
patient safety.
    Another reason that the AOA and the AOHA recommend national data 
remain confidential and secure is that such data could be used as 
background information for litigation. Any national data that is 
gathered should be considered information only for peer review. Since 
peer review protections vary greatly from state to state, at a minimum, 
any federal data gathering initiative must provide protection from 
discoverability and use in malpractice litigation. The data must be 
used only for the purpose of improving the safety standards of American 
healthcare.
    The AOA and the AOHA stand ready to support the IOM in improving 
patient safety in the United States. We welcome the opportunity to work 
with this committee and others dedicated to patient safety. Our members 
and staff are available to assist in the development of legislation 
that would lead to the continued improvement of the American healthcare 
system.
                                 ______
                                 
         Prepared Statement of National Medical Concepts, Inc.
    New Medical Concepts, Inc. (NMC), a telecommunications and 
healthcare information company headquartered in Fort Lauderdale, FL is 
pleased to present this statement for the hearing record to the House 
Commerce Committee Subcommittees on Oversight and Health and 
Environment and the House Veterans Affairs' Subcommittee on Health as 
they examine medical errors. We believe the Institute of Medicine's 
Report To Err Is Human: Building A Safer Health System and the report 
to Congress issued last week by the General Accounting Office on 
Adverse Drug Errors provide a strong basis for Congressional action on 
one of the most serious problems in our healthcare system: the need to 
improve patient safety.
    Our comments focus on problems associated with one of the most 
significant aspects of this problem in terms of impairment of quality 
of care and unnecessary costs: the need to assure safe prescription 
drug use by patients in the outpatient setting.
                       new medical concepts, inc.
    NMC was founded in 1997 by a group of business, healthcare and 
telecommunications professionals with recognized expertise in 
innovative technology, medicine, pharmacy and healthcare operations. 
The firm has developed RxAlerts, a unique voice and text messaging 
alert system using automated, personalized wireless and wired 
communications, which has the potential for dramatically reducing 
patient medication non-compliance and fostering more effective 
communications between healthcare providers and their patients.
    Most would acknowledge that drug therapy is often the most 
effective and cost-efficient way to achieve desired therapeutic 
outcomes in the treatment of patients. But drugs cannot work if they 
are not taken or are taken improperly. All drugs have side effects; 
some known, some unknown; some serious, some not. Because of the 
potential for harm and the increased significance of drug therapy as a 
treatment modality, safe medication use must be a priority objective in 
today's healthcare system. The problem of medication noncompliance is 
very real and demands practical solutions, the kind that foster 
integrated communication between patient and provider and which our 
company has developed.
Adverse Drug Events
    An adverse drug event (ADE) would typically be defined as any 
undesired effect associated with drug therapy such as harmful reactions 
(adverse drug reactions or ADRs), treatment failure, medication errors, 
overdoses and non-compliance. Consequences range from ineffective 
treatment to injuries, at times resulting in death. The population that 
is most at risk because of these events are the chronically ill 
patients of all ages and the elderly. With an aging population, the use 
of prescription drugs will rise and likewise, the risk of medication 
misuse and ADEs will also increase.
Medication Non-compliance
    We wish to emphasize to the Committee that the problems associated 
with medical errors and adverse drug events are just as significant 
(and probably more prevalent) in the outpatient setting as in the 
institutional setting. Certainly the overwhelming percentage of the 
several billion medications dispensed per year are to patients who are 
not in hospitals, nursing homes or other institutional settings, but 
who receive their drugs from community pharmacies. Safe medication use 
and the associated problem of medication non-compliance by patients in 
the ambulatory setting deserve this Committee's serious attention.
    Indeed, the General Accounting Office report on ``Adverse Drug 
Events'' released last week identified patient non-compliance in the 
ambulatory setting as a major source of adverse drug events. The report 
also described medication non-compliance as a major source of emergency 
room and hospital admissions. For example, the GAO cites a report 
finding that 58 percent of adverse drug events in patients visiting an 
emergency room were caused by medication non-compliance. Another study 
it cites found that 11 percent of all elderly admissions to a hospital 
were related to medication non-compliance. Among the proposals the GAO 
makes for reducing adverse drug events is improving communication 
between patients and physicians about the risks and benefits of 
medication.
           definition, reasons, those most seriously affected
    Medication non-compliance, or not taking a medicine as it was 
prescribed, is a worldwide health issue. Non-compliance includes taking 
too much medication, taking medication not prescribed, not taking 
medication prescribed, altering the prescribed dosage, or altering the 
time between doses. The reasons for non-compliance vary and may include 
forgetfulness, confusion over generic and brand names, unclear 
information about how to take or how much to take of a medication, 
disappearing symptoms of an illness, no perceived improvement in a 
patient's condition or well-being and, for those with low income, the 
difficult choice of having to select food or heat over drug 
expenditures. As with ADEs generally, the elderly and the chronically 
ill are particularly susceptible to the problem of medication non-
compliance. They usually take multiple prescriptions, and they are more 
susceptible to memory problems and confusion.
                          relevant statistics
 Thirty years ago (1970) only 650 medications were available; 
        today the number approaches 10,000
 Over 2.7 billion retail prescriptions were dispensed in the 
        U.S. in 1998. (GAO)
 30-50 percent of all prescriptions are not taken correctly. 
        (U.S. Food & Drug Administration)
 More than a billion prescriptions are taken incorrectly each 
        year. (U.S. Chamber of Commerce)
 The estimated annual cost of medication non-compliance exceeds 
        $100 billion. (National Pharmaceutical Council)
 Non-compliance kills 125,000 Americans each year. (National 
        Pharmaceutical Council)
                    social and economic consequences
    Non-compliance with the taking of medication has significant 
implications not only in terms of poor health outcomes for the patient 
but for the healthcare system itself. Its full effect on morbidity, 
mortality, and the associated healthcare costs are only beginning to be 
recognized. One national study revealed more than $75 billion in direct 
annual costs (with variable assumptions, the range was from $31 to $137 
billion) as a result of medication use problems in the United States. 
It based its findings on preventable treatment associated with 
increased admissions to hospitals and nursing homes and increased 
visits to physician offices and hospital emergency rooms which resulted 
from medication non-compliance.
    The costs estimated in this study related only to the direct cost 
of first time events and did not address consequential adverse health 
events (i.e., new medical problems resulting from the primary illness) 
or the indirect cost of lost employee productivity/absenteeism and 
turnover. When indirect costs due to non-compliance are added to the 
direct cost figures, total economic costs exceed $150 billion (Johnson, 
Jeffrey A. and J. Lyle Bootman. ``Drug-Related Morbidity and Mortality: 
A Cost-of-Illness Model,'' Archives of Internal Medicine 155:1949-56, 
Oct. 6, 1995). Drug-related morbidity and mortality costs are in the 
same range as diabetes, cardiovascular disease and obesity--leading 
some experts to suggest that drug-related problems should be considered 
a major category of disease.
                     failure to address the problem
    Medication non-compliance has reached the forefront of the medical 
community's awareness, but efforts to focus on safe medication use and 
the problem of medication non-compliance have been limited. While there 
have been major efforts made in developing technologies to detect and 
minimize adverse drug reactions, essentially sophisticated computer 
systems utilized by pharmacies and hospitals, these innovations do not 
address the more complex and subtle causal factors associated with 
noncompliance, notably communications between patient and healthcare 
professionals. Patient counseling requirements, consumer information 
sheets that accompany prescriptions, public service announcements, 
educational brochures and the specialized educational programs that are 
part of ``disease management'' programs are all positive developments, 
but have not proven sufficient to assure appropriate and safe 
medication use by patients. There have been few efforts made, 
technological or otherwise, to develop programs or products to assist 
health professionals and individual patients in dealing comprehensively 
with the problem.
conclusion: innovation that addresses medication non-compliance must be 
                               encouraged
    The inescapable conclusion is that if patients are non-compliant 
with medication therapy, desired outcomes (whether it be a cure, relief 
of symptoms or improved quality of life) are impaired. Indeed, it is 
clear that many emergency room and physician office visits and hospital 
and nursing home admissions could be prevented with interventions 
targeted at improving medication compliance. There can be little doubt 
that non-compliance is a significant health and economic burden on the 
healthcare system; that interventions directed at improving compliance 
will result in improved health outcomes; and that a significant cost 
savings will be realized through interventions directed at improving 
compliance.
    NMC believes our product RxAlerts is an effective and practical 
tool which will assist the healthcare system in addressing the problem 
of medication non-compliance. RxAlerts is a comprehensive medication 
compliance and support product/program which uses sophisticated state-
of-the-art software, utilizing proprietary computer time-clocking 
engines, to provide personal customized health-related information to 
patients from their health providers through wired and wireless 
communication media--alphanumeric and voice paging, facsimile 
transmission, cellular telephony, the internet, wired telephones and 
television (pending). The product applications have two-way 
communications capability and are encrypted to assure patient 
confidentiality. NMC is initially focusing its efforts on disease 
states like HIV, asthma, diabetes, post-organ transplants and certain 
pulmonary and heart conditions where medicine regimens are difficult, 
where there is a criticality of maintaining consistent medicine levels, 
where there is a need to modify or enhance behavior and where there is 
an overall need to communicate with patients on a regular basis.
    New Medical Concepts is encouraged that the Committee is examining 
the issue of medical errors, and we pledge to work with Congress, 
federal and state health agencies and the healthcare community in 
finding real world ``Patient Connectivity'' solutions which will foster 
safe medication use and improve the quality of care patients receive.
                                 ______
                                 
                Prepared Statement of Shands HealthCare
    Dear Mr. Chairman, Members of the Committee: I am writing as CEO of 
Shands HealthCare, with its mission of providing excellent patient 
care, improving community health, and supporting education and research 
for the State of Florida. Shands HealthCare is an integrated clinical 
delivery system, which offers the most comprehensive range of services 
in North Central Florida. The not-for-profit enterprise encompasses six 
acute care hospitals, two specialty hospitals, a home care company, and 
manages the University of Florida clinic operations as well as an 
extensive physician network. Shands at the University of Florida, the 
system's flagship hospital, is the academic medical center for the 
University of Florida Health Science Center and is recognized as one of 
the Southeasts leading tertiary care centers, and as such receives the 
majority of its patients from every county of Florida and Southeast 
Georgia. Shands at the University of Florida is closely linked with the 
College of Medicine at the University of Florida resulting in the 
development and delivery of cutting edge technology for the delivery of 
patient care.
    In addition, Shands HealthCare, the University of Florida, and 
University and Methodist Medical Centers have joined forces to form 
Shands Jacksonville, of which I am the Chairman of the Board of 
Directors.
    I also have the honor of serving as Chairman of the Council of 
Teaching Hospitals (COTH), a division of the Association of American 
Medical Colleges (AAMC), representing over 400 teaching hospitals 
across the nation. In addition, I serve on the Boards of the American 
Hospital Association and the Florida Hospital Association, and was 
recently elected Chair of the Florida Statutory Teaching Hospital 
Council. As a member of the Board of the National Committee for Quality 
Health Care, I have been directly involved in the promotion of quality 
for health care teams.
    We believe that we have a fundamental responsibility to continually 
improve the quality of care and services provided to our patients. As 
part of their mission, teaching hospitals provide a disproportionate 
share of the most complex health care services. This translates to 
patients entering the health system who are sicker and more complicated 
yielding health needs greater than those traditionally seen elsewhere.
    Hospitals have long recognized their role in improving the care 
provided to patients. Initiatives already in place at teaching 
hospitals include, but are not limited to: leadership commitment to 
improving the care provided; internal reporting of incidents for the 
identification of possible opportunities for improvement; use of 
external benchmarking; proactive attention to improving processes 
through the use of quality improvement tools and techniques; and, 
sharing of information related to trends and successes.
    Shands HealthCare participates in each of these, as well as 
required external reporting to the State of Florida for specified 
serious incidents. These reporting processes have only been successful 
because of the protections put in place by the Florida Legislature to 
maintain the confidentiality of the information reported. This is a 
crucial step to ensure that the process remains non-punitive and 
successful.
    One of the keys to success has been the focus of the Quality 
Committee of the Board of Directors on quality improvement, of which 
reducing efforts is but one component. Reporting of issues and 
involvement of the Board has reinforced the commitment at all levels of 
the organization to improving and maintaining the health of people in 
the State of Florida and the Southeastern United States.
    Thank you for your consideration and response to our desire to work 
closely with Congress as it pursues ways to continue to improve the 
quality of health care services.
                                 ______
                                 
Prepared Statement of American College of Physicians--American Society 
                          of Internal Medicine
    The American College of Physicians-American Society of Internal 
Medicine (ACP-ASIM), representing over 115,000 physicians who 
specialize in internal medicine and medical students with an interest 
in internal medicine, appreciates the opportunity to comment on the 
report of the Institute of Medicine (IOM), To Err is Human: Building a 
Safer Health System. Our membership includes practicing physicians, 
teaching physicians, residents, students, researchers, and 
administrators who are dedicated to assuring high quality medical care.
    The IOM report highlights unacceptable quality and safety problems 
in the nation's health care system. The report reveals that more people 
die each year as a result of medical errors than from motor vehicle 
accidents, breast cancer, or AIDS. It notes that medication errors 
alone account for over 7,000 deaths annually. This is a dismal record 
that exceeds the 6,000 deaths each year due to workplace injuries. 
Significantly, the IOM report finds that ``the problem is that the 
system needs to be made safer'' and indicates that the ``problem is not 
bad people.''
    The IOM report concludes that the U.S. health care industry lacks a 
systematic way of identifying, analyzing, and correcting unsafe 
practices. In order to achieve this end, the report states: 
``Preventing errors means designing the health care system at all 
levels to make it safer. Building safety into processes of care is a 
more effective way to reduce errors than blaming individuals. The focus 
must shift from blaming individuals for past errors to a focus on 
preventing future errors by designing safety into the system.'' The 
report lays out a comprehensive strategy for addressing these problems. 
It challenges the profession to make significant changes to achieve a 
safer health care system. We accept this challenge.
    ACP-ASIM offers the following comments regarding specific 
recommendations in the IOM report:
Creation of a Center for Patient Safety (IOM Recommendation 4.1):
    ACP-ASIM agrees with the IOM recommendation that a highly visible 
center is needed with secure and adequate funding to set national 
goals, evaluate progress, and develop and coordinate a research agenda 
to achieve improvements in patient safety. We firmly believe that such 
an effort should involve the many private sector initiatives that are 
also now underway. We concur with the IOM that a coordinated national 
effort is needed and that adequate and stable funding must be assured. 
If the center is to be housed in a federal agency, it should be in a 
non-regulatory agency such as the Agency for Healthcare Research and 
Quality (AHRQ). A coordinated program for research and achievement of 
national goals for improvements in patient safety should be as 
objective as possible and should not be tied to a federal agency with 
regulatory responsibilities. AHRQ has the expertise and an existing 
infrastructure for funding research and coordinating activities 
concerning health care quality. ACP-ASIM, therefore, supports increased 
funding for AHRQ to accomplish these expanded functions.
Mandatory Reporting (IOM Recommendation 5.1):
    The IOM report recognizes the need for both mandatory and voluntary 
error reporting systems. It explains that mandatory reporting systems 
are needed to hold providers accountable for their performance. It 
further advises that mandatory reporting should focus on the 
identification of serious adverse events (deaths or injuries resulting 
from medical interventions). The IOM notes that the focus of a 
mandatory reporting system should be narrowly defined. It recommends 
that the Forum for Health Quality Care Measurement and Reporting (The 
Quality Forum), a recently formed public/private partnership charged 
with developing a comprehensive quality measurement and public 
reporting strategy, should be responsible for promulgating and 
maintaining reporting standards.
    The IOM report also calls for licensing and accreditation bodies to 
expand the scope and magnitude to which patient safety is reviewed and 
evaluated in rendering licensing/accreditation decisions.
    ACP-ASIM agrees with the intent of this recommendation, but is 
concerned about its possible implementation. We strongly agree that 
physicians have a professional obligation to patients and society to 
report serious errors resulting in adverse events. It is appropriate 
that information on serious adverse events be reported to appropriate 
authorities and that a uniform, national reporting format be developed. 
We further agree that a public/private sector body, such as The Quality 
Forum, should be responsible for clearly defining what should be 
reported and developing the uniform reporting format. However, we are 
apprehensive about the possible role of the federal government in 
mandating what is to be reported and what will be done with the data. 
We urge Congress and federal agencies not to define reporting 
requirements too broadly or to be overly inclusive. We are concerned 
that mandatory reporting requirements could be excessively burdensome 
to institutions and individual physicians. We, therefore, agree with 
the IOM that a more narrowly defined program has a better chance of 
being successful.
    We also wish to highlight that the IOM calls for devoting adequate 
attention and resources for analyzing reports of adverse outcomes to 
identify those attributable to error. The IOM notes that it is only 
after careful analysis that the subset of reports attributable to error 
can be identified and follow up action taken. We agree with the IOM 
that the results of the analyses, not all data that are required to be 
reported, should be made available to the public.
    ACP-ASIM emphasizes that licensing and accreditation bodies 
considering patient safety issues in making licensing/accreditation 
decisions should not review every case patient record, but should 
review representative samples of patient care. Patient safety reviews 
should be completed within a reasonable time and with minimal 
disruption or additional administrative burdens for physicians or 
institutions.
Voluntary Reporting Systems (IOM Recommendation 5.2 and 6.1):
    The IOM calls for voluntary reporting systems to collect 
information on errors that cause minimal or no harm. It notes that 
voluntary reporting of less serious errors can identify and remedy 
patterns of errors and systemic problems. It notes that the aim of 
voluntary systems is to lead to improvements in patient safety and that 
the cooperation of health care professionals is essential. The IOM 
clearly recommends that voluntary reporting systems must be protected 
from legal discovery. IOM further recommends that Congress 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.
    ACP-ASIM supports voluntary reporting of incidents that do not 
result in fatalities or major errors, but could be symptomatic of 
systemic problems. However, protection of the confidentiality of data 
is essential to ensure that events involving medical errors or other 
incidents adversely effecting patient safety are reported and acted 
upon. Physicians and other health professionals have a responsibility 
to patients and the public to assure that all actions adversely 
affecting the quality and safety of patient care are reported and acted 
upon through a system of continuous quality improvement. However, ACP-
ASIM recommends that voluntary quality improvement systems must protect 
individual confidentiality. The confidentiality of reported data must 
be protected so that physicians and other health care professionals are 
encouraged to report all adverse incidents without fear that their 
cooperation will increase their exposure to law suits for professional 
liability or other sanctions. Any potential increased exposure to 
fines, loss of hospital privileges, or even possible loss of medical 
licensure will discourage physicians from voluntarily reporting ``near 
misses'' and other adverse incidents.
    Consequently, we strongly suggest that any voluntary reporting 
system must be primarily educational rather than punitive.
    Nevertheless, ACP-ASIM acknowledges that physicians have a 
professional obligation to disclose to patients information about 
procedural or judgment errors made in the course of care if such 
information is material to the patient's well-being. Errors do not 
necessarily constitute improper, negligent, or unethical behavior, but 
failure to disclose them may. (ACP-ASIM Ethics Manual, 1998, p.8-9)
The President's Executive Order
    In response to the IOM report, President Clinton announced on 
December 7, 1999, that he had signed an executive order directing a 
task force to analyze the report and report back within 60 days about 
ways to implement its recommendations. He also directed the task force 
to evaluate the extent to which medical errors are caused by misuse of 
medications or medical devices, and to develop additional strategies to 
reduce these errors. He further directed each of the more than 300 
private health plans participating in the Federal Employee Health 
Benefits Program to institute quality improvement and patient safety 
initiatives. He also signed legislation reauthorizing the Agency for 
Healthcare Research and Quality and providing $25 million for research 
to improve health care quality and prevent medical errors. The AHRQ 
will convene a national conference with state health officials to 
promote best practices in preventing medical errors. In addition, the 
President announced that he was directing his budget and health care 
teams to develop quality and patient safety initiatives for next year's 
budget.
    ACP-ASIM applauds all of these actions by the Executive branch to 
address the problems identified in the IOM report.
Issues for Further Review
    The IOM report raises many questions that will require further 
examination. We urge Congress to consider the following:

 What should be required for mandatory reporting? Should 
        reporting be required only for the most egregious errors 
        involving death or serious injury? How will ``serious errors'' 
        be distinguished from ``less serious'' errors? Will mandatory 
        reporting be cumulative, by institutions or by individual 
        physicians?
 To whom should data be reported? Should it be reported to 
        state agencies only, to states and the federal government, or 
        to private agencies?
 What data should be released to the public? For errors causing 
        serious injury or death, what should be the extent of data 
        released? Should everything be reported or just the final 
        analysis? Does the public have a right to know the number of 
        adverse incidents reported by a physician?
 What happens to the information that is reported? Will there 
        be follow-up actions, and if so, will these be released to the 
        public? Who will have access to the raw data, and will there be 
        adequate protections of confidentiality?
 Should licensing bodies use data on errors to deny or revoke 
        physician licenses? Should data on physicians be available to 
        hospitals for consideration in granting or denying hospital 
        privileges?
 How can reporting requirements avoid creating excessive costs 
        and administrative burdens for physicians and health care 
        organizations?
Conclusion
    ACP-ASIM is strongly supportive of the recommendations of the IOM 
report, To Err is Human: Building a Safer Health System. The College 
agrees that far too many preventable errors are committed that do not 
get reported and that solutions are needed to improve the quality and 
safety of patient care. ACP-ASIM concurs with the IOM's conclusion that 
the focus must be the reform of the system, not the punishment of 
individuals. ACP-ASIM encourages the profession to take up the 
challenge raised by the IOM to improve the quality and safety of 
patient care. The College supports setting a national goal of reducing 
medical errors by 50% within five years. Such an achievement will 
require substantial commitment of resources and effort. Substantial 
financial costs will be involved, but these may be largely offset by 
benefits in improved patient care and better health outcomes. 
Regardless of the costs, the public has a right to expect health care 
that is safe and effective. The profession is responsible to individual 
patients and to the public to continuously seek to improve the quality 
of medical care and make sure that health care services are provided as 
safely as possible.
    The College applauds the prompt initiatives instituted by the 
President and will look forward to working with Congress in addressing 
issues requiring legislative action. However, as we have indicated, 
there are many questions that need to be addressed before a national 
plan with mandatory and voluntary reporting requirements can be 
implemented. ACP-ASIM appreciates the deliberation that the Committee 
is giving to the IOM report and the opportunity to submit testimony. We 
are prepared to work with the Congress and the Administration to reduce 
the number of medical errors.
                                 ______
                                 
 Prepared Statement of Hon. Helen Chenoweth-Hage, a Representative in 
                    Congress from the State of Idaho
    I would like to thank Chairman Bilirakis and Chairman Everett for 
holding today's hearing. I appreciate the subcommittees for holding a 
joint hearing to discuss ways to improve the quality of our nation's 
healthcare system. By working together we can reduce the frequency of 
medical errors.
    When the Institute of Medicine released a report ``To Err is Human: 
Building a Safer Health System'', I was shocked to learn that as many 
as 98,000 preventable deaths occur each year.
    If this is true, then the frightening thing is, no one knows the 
exact number of preventable deaths. Each year, an estimated 44,000 to 
98,000 patients preventable deaths occur in our healthcare system. 
Forty-four thousand and 98,000 is an unacceptably high number. Why 
can't the Administration determine with more precision the actual 
number of preventable deaths? Why are so many preventable deaths 
occurring in the world's most advanced nation? The high number of 
preventable deaths is unacceptable. We can and must do more. People 
must have faith in the system.
    As Congress works to improve the quality of medical care, we must 
also work to restore people's trust in the system. They are, after all, 
entrusting their precious lives in the hands of America's doctors. 
Patients must be assured that they are receiving high quality care at 
all times.
    I look forward to hearing from our excellent panels of witnesses. 
We must take their recommendations to heart. After all, they are the 
ones who deal with the system on an everyday basis.
    Chairman Bilirakis and Chairman Everett, I thank both of you for 
holding this hearing and I look forward to working with everyone on 
both committees to improve our nation's healthcare system.
                                 ______
                                 
                 Consumer Coalition for Quality Health Care
                                                   February 7, 2000
The Honorable Michael Bilirakis, Chairman
Subcommittee on Health and Environment
Commerce Committee
U.S. House of Representatives
2125 Rayburn HOB
Washington, DC 20515
    Dear Chairman Bilirakis: I am writing in support of your efforts to 
examine ways that the federal government can address the issue of 
medical errors. As the Institute of Medicine (IOM) report released last 
fall revealed, medical errors are unnecessarily robbing our nation of 
valuable lives and resources. It is critical that Congress focus on 
ways to systematically attack this crisis in the health care industry 
and your hearing this week will help to move this public discussion 
forward.
    As the Committee considers alternatives to identifying, measuring, 
and reducing medical errors in the health care system, I ask that you 
carefully consider the appropriate use of the quality monitoring and 
improvement infrastructure that already exists. Quality Improvement 
Organizations (QIOs), also known as Medicare Peer Review Organizations 
(PROs), offer a unique opportunity for Congress to quickly address some 
of the medical error issues outlined in the IoM study. PROs already 
evaluate and work to improve the quality of care provided to millions 
of Medicare beneficiaries.
    QIOs are known to the consumer community for their work in 
community-based quality improvement projects and hospital discharge 
appeals. They have a strong track record in using multidisciplinary 
teams with the clinical expertise necessary to work with providers and 
purchasers in the private sector with the goal of reducing medical 
errors and improving the quality of care for Medicare and Medicaid 
patients.
    Any national system to reduce medical errors must be perceived by 
consumers as objective and sufficiently independent. QIOs have the 
appropriate external independence necessary to carry out the difficult 
and often sensitive work of identifying and working to correct medical 
errors.
    As the Committee weighs its options on public reporting of serious 
medical errors and a national approach to reduce medical errors and 
``near misses,'' please consider the value of those entities that can 
successfully identify the root-causes of errors, the best practices 
from across the country, and objectively assist hospitals in developing 
systems interventions. I believe that you will find there is great 
potential in using the PRO system. They are available to do this kind 
of work in every state without creating a new infrastructure--this 
would provide consistency and save valuable resources.
    Thank you for your consideration of these important issues. I look 
forward to working with you on these and other concerns regarding 
medical errors in the future.
            Sincerely,
                                                  Brian W. Lindberg
                                 ______
                                 
                 Consumer Coalition for Quality Health Care
                                                   February 7, 2000
The Honorable Sherrod Brown, Ranking Minority Member
Subcommittee on Health and Enviroment
Commerce Committee
U.S. House of Representatives
2125 Rayburn HOB
Washington, DC 20515
    Dear Ranking Minority Member Brown: I am writing in support of your 
efforts to examine ways that the federal government can address the 
issue of medical errors. As the Institute of Medicine (IOM) report 
released last fall revealed, medical errors are unnecessarily robbing 
our nation of valuable lives and resources. It is critical that 
Congress focus on ways to systematically attack this crisis in the 
health care industry and your hearing this week will help to move this 
public discussion forward.
    As the Committee considers alternatives to identifying, measuring, 
and reducing medical errors in the health care system, I ask that you 
carefully consider the appropriate use of the quality monitoring and 
improvement infrastructure that already exists. Quality Improvement 
Organizations (QIOs), also known as Medicare Peer Review Organizations 
(PROs), offer a unique opportunity for Congress to quickly address some 
of the medical error issues outlined in the IoM study. PROs already 
evaluate and work to improve the quality of care provided to millions 
of Medicare beneficiaries.
    QIOs are known to the consumer community for their work in 
community-based quality improvement projects and hospital discharge 
appeals. They have a strong track record in using multidisciplinary 
teams with the clinical expertise necessary to work with providers and 
purchasers in the private sector with the goal of reducing medical 
errors and improving the quality of care for Medicare and Medicaid 
patients,
    Any national system to reduce medical errors must be perceived by 
consumers as objective and sufficiently independent. QIOs have the 
appropriate external independence necessary to carry out the difficult 
and often sensitive work of identifying and working to correct medical 
errors.
    As the Committee weighs its options on public reporting of serious 
medical errors and a national approach to reduce medical errors and 
``near misses,'' please consider the value of those entities that can 
successfully identify the root-causes of errors, the best practices 
from across the country, and objectively assist hospitals in developing 
systems interventions. I believe that you will find there is great 
potential in using the PRO system. They are available to do this kind 
of work in every state without creating a new infrastructure--this 
would provide consistency and save valuable resources.
    Thank you for your consideration of these important issues. I look 
forward to working with you on these and other concerns regarding 
medical errors in the future.
            Sincerely,
                                                  Brian W. Lindberg
                                 ______
                                 
 Prepared Statement of Hon. Constance A. Morella, a Representative in 
                  Congress from the State of Maryland
    Mr. Chairman and members of the Subcommittee, thank you for the 
opportunity to appear before you to heed the call for Congressional 
leadership in response to the recent report that as many as 98,000 
Americans die unnecessarily every year from medical mistakes made by 
physicians, pharmacists and other health care professionals.
    Before I read the November 29, 1999 report from the Institute of 
Medicine (IOM), I knew that the human cost of medical errors was high. 
However, I was surprised to read that medical errors kill between 
44,000 and 98,000 people in U.S. hospitals each year. The IOM report 
estimates that the financial costs of these preventable errors are 
between $17 billion and $29 billion each year. Medical errors afflict 
patients in a variety of health care settings, including hospitals, 
day-surgery and outpatient clinics, retail pharmacies, nursing homes, 
and even in home care. The magnitude of this loss of life is staggering 
because these numbers mean more people die from avoidable medical 
mistakes each year than from highway accidents, breast cancer, or AIDS. 
Yet while other areas of the U.S. economy have coordinated safety 
programs that collect and analyze accident trends, including those that 
track nuclear reactor accidents, highway crashes and airline disasters, 
there is no centralized system for keeping tabs on medical errors and 
using that information to prevent future mistakes.
    According to the IOM report, the majority of medical errors do not 
result from individual recklessness, but from basic flaws in the way 
the health system is organized. For example, stocking patient-care 
units in hospitals with certain full-strength drugs--even though they 
are toxic unless diluted--has resulted in deadly mistakes. Also, 
illegible writing in medical records has resulted in the administration 
of a drug for which the patient has a known allergy. A May, 1999 report 
from the U.S. Pharmacopeia (a copy of which is attached) found that 
confusion over similarly named drugs, such as ``Cefuroxime'' versus 
``Cefotaxime,'' accounts for approximately one-quarter of all reports 
to the USP Medication Errors Reporting Program.
    In addition to the preceding examples, other concerns stem from the 
increasing complexity of numerous health care specialists where, when a 
patient is treated by several practitioners, they often do not have 
complete information about the medicines prescribed by other 
practitioners or the patient's illnesses unrelated to the specific 
concern that practitioner is addressing.
    Before the technological advances we've benefitted from over the 
past decades, scientific knowledge moved forward through the concept of 
``trial and error.'' Unfortunately, expecting each of the thousands of 
Americans hospitals to continue to rely on trial and error to improve 
patient care is not an acceptable solution when it comes to protecting 
the quality of human life. Mr. Chairman, we have the technology before 
us to remedy the lack of coordination resulting from our rapidly 
evolving health care system and to stop putting patients at risk as 
mistakes are repeated because one practitioner cannot learn from the 
mistakes of another.
    One solution specifically suggested in the IOM report is the 
increased utilization of the voluntary reporting system called MedMARx. 
MedMARx is maintained by the U.S. Pharmacopoeia (USP), a not-for-
profit, volunteer-based, private organization located in my district in 
Rockville, Maryland. The mission of the USP is to promote the public 
health by establishing and disseminating officially recognized 
standards of quality and authoritative information for the use of 
medicines and other health care technologies by health professionals, 
patients, and consumers.
    The MedMARx program, launched in August 1998, is a national 
Internet-based, anonymous database designed to help prevent and reduce 
medication efforts in hospitals. MedMARx is based upon the premise that 
the sharing of field experiences and concerns among health care 
professionals is important to reducing medication errors and providing 
safer, better quality health care. MedMARx allows hospitals to 
anonymously report, track, and monitor their medication errors, and to 
identify trends and pinpoint problem areas. Users also can learn from 
the experiences of other hospitals. By using MedMARx, hospitals 
throughout the United States can learn from other hospitals and their 
experiences with proactive risk assessment and product processes. This 
revolutionary method of risk avoidance improves patient safety and the 
quality of patient care, while reducing the substantial financial and 
emotional costs associated with medication errors.
    MedMARx now boasts 100 hospitals throughout the United States as 
participants, making it the first national program to help hospitals 
prevent medication errors. However, in order to make this system more 
successful, and with the encouragement of Dianne Cousins, R.Ph., Vice 
President for USP, I will soon introduce legislation to encourage the 
growth of MedMARx by giving hospitals and health care professionals the 
incentive to voluntarily report problems encountered during clinical 
practice. According to USP, it is ``clear that a significant obstacle 
to the full implementation of any national medication error reporting 
program is the lack of disclosure of the reports in civil litigation 
and regulatory investigation.'' Therefore, my legislation will protect 
the confidentiality of MedMARx data on medical mistakes where the 
information is collected and analyzed solely for the purpose of 
improving safety and quality. The information covered by my legislation 
shall not be subject to subpoena or discovery in any administrative or 
civil proceeding, provided, however, that these materials are kept 
confidential. Further, the protection afforded by my legislation will 
not extend to the underlying fact that an error occurred, which would 
be otherwise discoverable by traditional means. Without the protection 
afforded by this simple but important legislation, hospitals and health 
care professionals fear that information reported to MedMARx might 
ultimately be subpoenaed and used in lawsuits against them, thereby 
discouraging their participation in MedMARx.
    I am committed to working with my colleagues in Congress to promote 
the widespread use of MedMARx and allow the USP to build a 
comprehensive Internet-based information database to provide feedback 
to reporting professionals, product manufacturers, and regulatory 
agencies. Working together, Congress can ensure the success of MedMARx 
and begin improving patient safety and the quality of patient care, and 
as a result, reduce the substantial financial and emotional costs 
associated with medication errors.
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