Table Of Content

S. HRG. 106–847 MEDICAL MISTAKES JOINT HEARINGS BEFORETHE SUBCOMMITTEE ON LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND RELATED AGENCIES COMMITTEE ON APPROPRIATIONS THE COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS ANDTHE COMMITTEE ON VETERANS’ AFFAIRS UNITED STATES SENATE ONE HUNDRED SIXTH CONGRESS FIRST AND SECOND SESSIONS SPECIAL HEARINGS Printed for the use of the Committees on Appropriations, Health, Education, Labor, and Pensions, and Veterans’ Affairs ( Available via the World Wide Web: http://www.access.gpo.gov/congress/senate U.S. GOVERNMENT PRINTING OFFICE 61–732cc WASHINGTON : 2001 For sale by the U.S. Government Printing Office Superintendent of Documents, Congressional Sales Office, Washington, DC 20402 COMMITTEE ON APPROPRIATIONS TED STEVENS, Alaska, Chairman THAD COCHRAN, Mississippi ROBERT C. BYRD, West Virginia ARLEN SPECTER, Pennsylvania DANIEL K. INOUYE, Hawaii PETE V. DOMENICI, New Mexico ERNEST F. HOLLINGS, South Carolina CHRISTOPHER S. BOND, Missouri PATRICK J. LEAHY, Vermont SLADE GORTON, Washington FRANK R. LAUTENBERG, New Jersey MITCH MCCONNELL, Kentucky TOM HARKIN, Iowa CONRAD BURNS, Montana BARBARA A. MIKULSKI, Maryland RICHARD C. SHELBY, Alabama HARRY REID, Nevada JUDD GREGG, New Hampshire HERB KOHL, Wisconsin ROBERT F. BENNETT, Utah PATTY MURRAY, Washington BEN NIGHTHORSE CAMPBELL, Colorado BYRON L. DORGAN, North Dakota LARRY CRAIG, Idaho DIANNE FEINSTEIN, California KAY BAILEY HUTCHISON, Texas RICHARD J. DURBIN, Illinois JON KYL, Arizona STEVEN J. CORTESE, Staff Director LISA SUTHERLAND, Deputy Staff Director JAMES H. ENGLISH, Minority Staff Director SUBCOMMITTEE ON LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND RELATED AGENCIES ARLEN SPECTER, Pennsylvania, Chairman THAD COCHRAN, Mississippi TOM HARKIN, Iowa SLADE GORTON, Washington ERNEST F. HOLLINGS, South Carolina JUDD GREGG, New Hampshire DANIEL K. INOUYE, Hawaii LARRY CRAIG, Idaho HARRY REID, Nevada KAY BAILEY HUTCHISON, Texas HERB KOHL, Wisconsin TED STEVENS, Alaska PATTY MURRAY, Washington JON KYL, Arizona DIANNE FEINSTEIN, California ROBERT C. BYRD, West Virginia (Ex officio) Professional Staff BETTILOU TAYLOR MARY DIETRICH JIM SOURWINE AURA DUNN ELLEN MURRAY (Minority) Administrative Support KEVIN JOHNSON CAROLE GEAGLEY (Minority) (II) COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS JAMES M. JEFFORDS, Vermont, Chairman JUDD GREGG, New Hampshire EDWARD M. KENNEDY, Massachusetts BILL FRIST, Tennessee CHRISTOPHER J. DODD, Connecticut MIKE DEWINE, Ohio TOM HARKIN, Iowa MICHAEL B. ENZI, Wyoming BARBARA A. MIKULSKI, Maryland TIM HUTCHINSON, Arkansas JEFF BINGAMAN, New Mexico SUSAN M. COLLINS, Maine PAUL D. WELLSTONE, Minnesota SAM BROWNBACK, Kansas PATTY MURRAY, Washington CHUCK HAGEL, Nebraska JACK REED, Rhode Island JEFF SESSIONS, Alabama MARK E. POWDEN, Staff Director SUSAN K. HATTAN, Deputy Staff Director J. MICHAEL MYERS, Minority Staff Director and Chief Counsel COMMITTEE ON VETERANS’ AFFAIRS ARLEN SPECTER, Pennsylvania, Chairman STROM THURMOND, South Carolina JOHN D. ROCKEFELLER IV, West Virginia FRANK H. MURKOWSKI, Alaska BOB GRAHAM, Florida JAMES M. JEFFORDS, Vermont DANIEL K. AKAKA, Hawaii BEN NIGHTHORSE CAMPBELL, Colorado PAUL W. WELLSTONE, Minnesota LARRY E. CRAIG, Idaho PATTY MURRAY, Washington TIM HUTCHINSON, Arkansas CHARLES BATTAGLIA, Staff Director JIM GOTTLIEB, Minority Chief Counsel/Staff Director (III) CONTENTS MONDAY, DECEMBER 13, 1999 Page Opening statement of Senator Arlen Specter ........................................................ 1 Statement of Dr. John Eisenberg, Director, Agency for Healthcare Research and Quality, Department of Health and Human Services ............................... 2 Statement of Mary Wakefield, Ph.D., member, Quality of Health Care in America Committee, Institute of Medicine; director, Center for Health Pol- icy, Research and Ethics, George Mason University......................................... 8 Statement of Ray McEachern, president, Association for Responsible Medi- cine, Tampa, FL ................................................................................................... 14 Statement of Patricia McEachern .......................................................................... 16 Statement of Diane Artemis, Falls Church, VA .................................................... 19 Statement of Debra Malone, Vail, CO ................................................................... 23 Statement of Dr. Nancy Dickey, immediate past president, American Medical Association ............................................................................................................ 28 Statement of by Anne Shea, acting executive director and chief operating officer, National Patient Safety Foundation ...................................................... 28 Summary statement ......................................................................................... 29 Statement of Mary Foley, R.N., first vice president, American Nurses Associa- tion ........................................................................................................................ 33 Statement of Stanton Smullens, chief medical officer, Jefferson Health Sys- tem, Philadelphia ................................................................................................. 38 Statement of Martin D. Merry, M.D., associate professor of health manage- ment, University of New Hampshire .................................................................. 41 Prepared statement of Hon. Pete Stark, U.S. Representative from Califor- nia.......................................................................................................................... 47 Prepared statement of the United States Pharmacopeia ..................................... 48 Prepared statement of Salvador Castro, Professional Engineer .......................... 52 TUESDAY, JANUARY 25, 2000 Opening statement of Senator Arlen Specter ........................................................ 55 Prepared statement of Senator John D. Rockefeller IV ....................................... 57 Statement of Molly Joel Coye, M.D., member, Institute of Medicine, Com- mittee on Quality of Health Care in America.................................................... 65 Statement of Thomas L. Garthwaite, M.D., Acting Under Secretary for Health, Department of Veterans Affairs ............................................................ 75 Prepared statement .......................................................................................... 77 Statement of Joseph Donahey, Circuit Court Judge, Pasco County, FL............. 90 Statement of Ralph Specken, M.D., New York, NY .............................................. 93 TUESDAY, FEBRUARY 22, 2000 Opening statement of Senator Bill Frist ............................................................... 99 Prepared statement of Senator James Jeffords .................................................... 101 Opening statement of Senator Edward M. Kennedy ............................................ 102 Prepared statement .......................................................................................... 104 Opening statement of Senator Arlen Specter ........................................................ 104 Opening statement of Senator Tom Harkin .......................................................... 105 Opening statement of Senator Susan M. Collins .................................................. 106 Opening statement of Senator Jack Reed.............................................................. 107 Opening statement of Senator Jeff Bingaman ...................................................... 107 Opening statement of Senator Christopher J. Dodd............................................. 107 Prepared statement .......................................................................................... 107 (V) VI Page Statement of Dr. John M. Eisenberg, Director, Agency for Healthcare Re- search and Quality, Department of Health and Human Services, and Oper- ating Chair, Quality Interagency Coordinating Task Force ............................. 108 Prepared Statement ......................................................................................... 113 Statement of Dr. Thomas Leonard Garthwaite, Deputy Under Secretary for Health, Department of Veterans Affairs ............................................................ 116 Prepared statement .......................................................................................... 118 Statement of Dr. I. Steven Udvarhelyi, senior vice president and chief medical officer, Independence Blue Cross, Philadelphia, PA, on behalf of the Amer- ican Association of Health Plans ........................................................................ 165 Prepared statement .......................................................................................... 166 Statement of Dr. Thomas R. Russell, executive director, American College of Surgeons ........................................................................................................... 170 Prepared statement .......................................................................................... 172 Statement of Dr. Dennis O’Leary, president, Joint Commission on Accredita- tion of Healthcare Organizations, Chicago, IL .................................................. 176 Prepared statement .......................................................................................... 178 Statement of Dr. Arnold S. Relman, professor Emeritus of Medicine and of Social Medicine, Harvard Medical School, Boston, MA ................................ 187 Prepared statement .......................................................................................... 189 Prepared statement of the American Academy of Orthopaedic Surgeons and the American Association of Orthopaedic Surgeons.......................................... 205 Prepared statement of the American College of Physicians—American Society of Internal Medicine............................................................................................. 207 Prepared statement of the American College of Radiology .................................. 211 Prepared statement of Healthcare Provider Credentials Verification Associa- tion ........................................................................................................................ 212 Prepared statement of the National Association of Chain Drug Stores.............. 214 MEDICAL MISTAKES MONDAY, DECEMBER 13, 1999 U.S. SENATE, SUBCOMMITTEE ON LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND RELATED AGENCIES, COMMITTEE ON APPROPRIATIONS, Washington, DC. The subcommittee met at 10:30 a.m., in room SD–138, Dirksen Senate Office Building, Hon. Arlen Specter (chairman) presiding. Present: Senator Specter. OPENING STATEMENT OF SENATOR ARLEN SPECTER Senator SPECTER. Good morning. The hour of 10:30 having ar- rived, the Committee on Labor, Health, Human Resources, and Education of the Appropriations Committee will proceed with our hearing. On November 29, the Institute of Medicine issued a report enti- tled ‘‘To Err is Human: Building a Safer Health System,’’ which cataloged an enormous number of medical errors which occur at our health care delivery system hospitals and doctors offices. Now, this had followed some rather dramatic disclosures about medical errors. A prominent health reporter in the Boston Globe, Betsy Layman, died from an overdose during treatment in Florida. Mr. Willy King had the wrong leg amputated. Two large studies, one conducted in Colorado and another in Utah, found adverse events occurring in about 3 to 4 percent of hospitalizations, respectively, and the pro- jected estimates are that as many as 44,000 Americans may die each year from medical errors. These errors comprised the fifth leading cause of death in the United States, with the costs esti- mated in the range of $20 billion a year. The study of the Institute of Medicine recommended that the Agency for Health Care Research and Quality receive an appropria- tion initially of some $30 million. That agency is funded by this subcommittee, and it was decided that we should push ahead with the hearing at an early date, even though the Congress is in recess at this time, so that we may investigate the issue and proceed with the dialogue, hopefully being in the position to introduce legislation on this subject when the Congress reconvenes in late January. There are a number of agencies, really, to be heard from on this matter, and today’s hearing will really just begin the dialogue, but the issue has been raised. In addition to the Agency for the Health Care Research and Quality, a number of other agencies funded through the initiation of this subcommittee may also have an im- (1) 2 portant role to play, such as the Health Care Financing Adminis- tration, the National Institutes of Health, which received an enormous increase in funding, some $2.3 billion this year, to a total of almost $18 billion a year, the Centers for Disease Control, the Health Resources and Services Administration, the Administration on Aging, Substance Abuse, and Mental Health Administration, and also the surgeon general’s office. I might say parenthetically, I talked to Dr. Satcher last week about that very important report on mental health, which is to be released today, and the advanced billing show that to be a matter of enormous concern, and, again, a subject which has been funded through this subcommittee, having enormous implications, which we may have a hearing on later and address those issues. STATEMENT OF DR. JOHN EISENBERG, DIRECTOR, AGENCY FOR HEALTHCARE RESEARCH AND QUALITY, DEPARTMENT OF HEALTH AND HUMAN SERVICES Senator SPECTER. A fuller statement will be admitted for the record, but to proceed at the earliest moment with our very distin- guished panel of witnesses, I would like to call at this time Dr. John Eisenberg and Dr. Mary Wakefield to be our initial witnesses. Dr. Eisenberg is the Administrator of the Agency for Healthcare Research and Quality, the agency called upon by this study to take the lead in addressing these serious issues. Dr. Eisenberg was chairman of the Department of Medicine of Physicians, and Chief at Georgetown University, and before that was the Chief of Gen- eral Internal Medicine at the University of Pennsylvania, a grad- uate of Princeton, Washington University, St. Louis School of Medi- cine, and the Wharton Business School. That is quite a varied background, Dr. Eisenberg. Thank you for joining us here today, and the floor is yours. Dr. EISENBERG. Thank you, Senator Specter. Mr. Chairman, when I read the Institute of Medicine’s report on patient safety and errors in the health care system, I, like every physician, had some reminiscences. It brought back some memories. I recall the woman whom I took care of; we had had a pap test done to screen her for cervical cancer. The result was suspicious, but I never knew that, because I never got the report back, and I did not realize that I had not gotten the report back until she called me and asked about the report. I tracked it down. I found out it was suspicious. We followed it up, and fortunately, it turned out not to be anything serious, but that was a near miss, and it was a near miss that could have been a tragedy, had she not called me, had she not taken part in detect- ing and preventing errors. That happened at the University of Pennsylvania, when I headed the General Internal Medicine Divi- sion there. It is a great hospital, as you know, but even at the best institutions, errors happen. Senator, when I spoke at three medical school graduations last spring, I asked all of the students who were graduating, and I asked all of the faculty to raise their hands if they had ever made a mistake in taking care of a patient, and every single student raised his or her hand, and every faculty member raised his or her hand. So we have established the fact that these errors exist; we 3 have established that the best physicians at the best institutions make mistakes. What the Institute of Medicine’s report has done, has been to alert us to the magnitude of this problem, to point out to us that if it were a disease, it would be the eighth leading cause of death in the United States. But if it were a disease, Senator Specter, I think we would call it an epidemic. Senator SPECTER. Dr. Eisenberg, did you say the eighth leading cause of death—— Dr. EISENBERG. The eighth leading cause. Senator SPECTER [continuing]. Not the fifth leading cause of death? Dr. EISENBERG. Not the fifth. The eighth. It is somewhere between 44,000 and 98,000 deaths per year, is what the IOM has es- timated. Now, that is bad news, but there is some good news, and the good news is that these errors can be prevented. If this were a disease, then let us think about what we would do. We would attack it with the best research that we could muster, we would put resources into translating that research into im- proved practices, and it is going to take resources, and it is going to take teamwork in order for us to respond to this problem. I want to commend you, Mr. Chairman, and the other Members of the Senate and the House of Representatives for recently taking what I think is a significant and very timely step in November to reauthorize our agency and to rename it from the Agency for Health Care Policy and Research to the Agency for Healthcare Re- search and Quality, or AHRQ, as we will call it. The name quality in our name is very important, because this is an issue of health care quality. Errors and even near misses, like the one that I had, are not new problems, but they have finally gotten the attention that they deserve. Congress did show foresight in raising the awareness of medical errors as an important part of the health care quality agency through that legislation that reauthorized our agency and renamed it. You gave AHRQ not only the authority, but you gave us the re- sponsibility to carry forward many of the error prevention rec- ommendations in the Institute of Medicine’s report. Now, while an investment is going to be required to make system improvements to reduce medical errors, I think we can be confident that it will also reap substantial benefits. In the long run, when these medical errors are prevented, the IOM estimates that we could save as much as $8.8 billion that is spent on health care today. The research we have sponsored shows that many adverse drug reactions and events can be prevented if appropriate systems are put in place. I recall, for example, in the mid-1980s, when at Penn, our faculty developed with the Philadelphia College of Pharmacy and Science, one of the first systems to detect adverse drug reactions, and these kinds of systems are now being computerized, but Senator Specter, it is more than just about drug errors. In fact, the Institute of Medicine found that while about 10 percent of the errors clearly involve drugs, 12 percent of them were the failure to prevent an injury, and 17 percent were diagnostic mistakes, like the one that I almost made. 4 While the statistics of errors are astonishing to many and they are distressing to all of us, it is very important for us to remember that the IOM emphasized that this is a problem of the health care system, not incompetent careless individuals. Our approach to medical mistakes has to change from the old mode of name them, blame them, and shame them, to one of look- ing at systems, finding out what the root causes of these errors are, and then sharing information so that those errors are not repeated. Like the patients that they care for, health care professionals are human, and we humans are not perfect. As the IOM report recog- nized, to err is, in fact, human. Now, research has shown us that errors exist, and we need to understand the dimensions of those errors, but we cannot stop just by counting the errors. We have to evaluate why they occur, and then we have to develop systems in order to prevent them. Our new name, AHRQ, is symbolic of the need to develop an arc or a bridge between the problem and its solution, between what we know and what we actually do in health care. Let me give you one example. Our agency funded a study that tested whether emergency rooms could put together dedicated chest pain observation units, which could reduce the number of people who are mistakenly sent home even though they have had a heart attack. These units have specially trained staff, they have dedicated equipment, and they have validated treatment protocols that have led them to reduce the number of people who are sent home mistakenly by as much as 100-fold, says the research. We can learn from the aviation industry, as we know, and we know that in health care more can be done as well. Some of the earliest research, in fact, in error reduction in health care was done in anesthesia. Applying the lessons of that research has allowed anesthesiologists, the people who provide anesthesia for surgery, to reduce their error rate by about seven fold. We have seen, in the Department of Defense and in the Depart- ment of Veterans Affairs, programs that show that improvements can be made in reducing errors, but if we are going to reduce errors in health care, Senator Specter, we are going to have to share information on those practices and share information on effective so- lutions, but we cannot share information if we do not have information. What the Institute of Medicine’s report told us is that we can help change the culture of secrecy surrounding medical errors into a culture of education and improvement. I want to thank you and your colleagues for providing our agency with the funding that you mentioned earlier in fiscal year 2000. That, combined with our new authorizing language, is going to allow us to make a down payment on research in this critical area. We have already expanded our commitment to research in reducing medical errors. We are going to fund about $2 million in research on medical errors and patient safety this year, identify op- portunities for further research that we can carry out in the future, and continue supporting a very exciting new initiative, the Centers for Education and Research in Therapeutics (CERTS). You may have seen the article about CERTS in the Wall Street Journal on Friday, which will help to reduce adverse events from drugs, and