[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.
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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
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\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
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\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.
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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.
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\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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