<DOC>
[107th Congress House Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:79468.wais]
REDUCING MEDICAL ERRORS: A REVIEW OF INNOVATIVE STRATEGIES TO IMPROVE
PATIENT SAFETY
=======================================================================
HEARING
before the
SUBCOMMITTEE ON HEALTH
of the
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED SEVENTH CONGRESS
SECOND SESSION
__________
MAY 8, 2002
__________
Serial No. 107-112
__________
Printed for the use of the Committee on Energy and Commerce
Available via the World Wide Web: http://www.access.gpo.gov/congress/
house
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__________
COMMITTEE ON ENERGY AND COMMERCE
W.J. ``BILLY'' TAUZIN, Louisiana, Chairman
MICHAEL BILIRAKIS, Florida JOHN D. DINGELL, Michigan
JOE BARTON, Texas HENRY A. WAXMAN, California
FRED UPTON, Michigan EDWARD J. MARKEY, Massachusetts
CLIFF STEARNS, Florida RALPH M. HALL, Texas
PAUL E. GILLMOR, Ohio RICK BOUCHER, Virginia
JAMES C. GREENWOOD, Pennsylvania EDOLPHUS TOWNS, New York
CHRISTOPHER COX, California FRANK PALLONE, Jr., New Jersey
NATHAN DEAL, Georgia SHERROD BROWN, Ohio
RICHARD BURR, North Carolina BART GORDON, Tennessee
ED WHITFIELD, Kentucky PETER DEUTSCH, Florida
GREG GANSKE, Iowa BOBBY L. RUSH, Illinois
CHARLIE NORWOOD, Georgia ANNA G. ESHOO, California
BARBARA CUBIN, Wyoming BART STUPAK, Michigan
JOHN SHIMKUS, Illinois ELIOT L. ENGEL, New York
HEATHER WILSON, New Mexico TOM SAWYER, Ohio
JOHN B. SHADEGG, Arizona ALBERT R. WYNN, Maryland
CHARLES ``CHIP'' PICKERING, GENE GREEN, Texas
Mississippi KAREN McCARTHY, Missouri
VITO FOSSELLA, New York TED STRICKLAND, Ohio
ROY BLUNT, Missouri DIANA DeGETTE, Colorado
TOM DAVIS, Virginia THOMAS M. BARRETT, Wisconsin
ED BRYANT, Tennessee BILL LUTHER, Minnesota
ROBERT L. EHRLICH, Jr., Maryland LOIS CAPPS, California
STEVE BUYER, Indiana MICHAEL F. DOYLE, Pennsylvania
GEORGE RADANOVICH, California CHRISTOPHER JOHN, Louisiana
CHARLES F. BASS, New Hampshire JANE HARMAN, California
JOSEPH R. PITTS, Pennsylvania
MARY BONO, California
GREG WALDEN, Oregon
LEE TERRY, Nebraska
ERNIE FLETCHER, Kentucky
David V. Marventano, Staff Director
James D. Barnette, General Counsel
Reid P.F. Stuntz, Minority Staff Director and Chief Counsel
______
Subcommittee on Health
MICHAEL BILIRAKIS, Florida, Chairman
JOE BARTON, Texas SHERROD BROWN, Ohio
FRED UPTON, Michigan HENRY A. WAXMAN, California
JAMES C. GREENWOOD, Pennsylvania TED STRICKLAND, Ohio
NATHAN DEAL, Georgia THOMAS M. BARRETT, Wisconsin
RICHARD BURR, North Carolina LOIS CAPPS, California
ED WHITFIELD, Kentucky RALPH M. HALL, Texas
GREG GANSKE, Iowa EDOLPHUS TOWNS, New York
CHARLIE NORWOOD, Georgia FRANK PALLONE, Jr., New Jersey
Vice Chairman PETER DEUTSCH, Florida
BARBARA CUBIN, Wyoming ANNA G. ESHOO, California
HEATHER WILSON, New Mexico BART STUPAK, Michigan
JOHN B. SHADEGG, Arizona ELIOT L. ENGEL, New York
CHARLES ``CHIP'' PICKERING, ALBERT R. WYNN, Maryland
Mississippi GENE GREEN, Texas
ED BRYANT, Tennessee JOHN D. DINGELL, Michigan,
ROBERT L. EHRLICH, Jr., Maryland (Ex Officio)
STEVE BUYER, Indiana
JOSEPH R. PITTS, Pennsylvania
W.J. ``BILLY'' TAUZIN, Louisiana
(Ex Officio)
C O N T E N T S
__________
Page
Testimony of:
Freeman, Kenneth W., Chairman and CEO, Quest Diagnostics
Incorporated on behalf of the Healthcare Leadership Council 15
Hethcox, James M., Vice President, Pharmacy Practice,
Cardinal Health, Inc....................................... 9
O'Leary, Dennis S., President, Joint Commission on
Accreditation of Healthcare Organizations.................. 22
Westra, Bonnie, American Nurses Association.................. 38
Williams, Roger L., U.S. Pharmacopeia........................ 29
Material submitted for the record by:
American Academy of Orthopaedic Surgeons, prepared statement
of......................................................... 55
American Federation of Labor and Congress of Industrial
Organizations, prepared statement of....................... 57
American Health Quality Association, prepared statement of... 58
American Medical Association, prepared statement of.......... 61
American Society for Clinical Pathology, prepared statement
of......................................................... 67
American Society of Radiologic Technologists, prepared
statement of............................................... 68
American Society for Quality, prepared statement of.......... 69
Harding, Jonathan, Medical Director, Fallon Clinic, prepared
statement of............................................... 86
Premier, Inc., prepared statement of......................... 89
(iii)
REDUCING MEDICAL ERRORS: A REVIEW OF INNOVATIVE STRATEGIES TO IMPROVE
PATIENT SAFETY
----------
WEDNESDAY, MAY 8, 2002
House of Representatives,
Committee on Energy and Commerce,
Subcommittee on Health,
Washington, DC.
The subcommittee met, pursuant to notice, at 10 a.m., in
room 2123, Rayburn House Office Building, Hon. Michael
Bilirakis (chairman) presiding.
Members present: Representatives Bilirakis, Deal, Ganske,
Cubin, Wilson, Shadegg, Brown, Barrett, Capps, Eshoo, Wynn, and
Green.
Staff present: Patrick Morrisey, deputy staff director and
majority counsel; Steve Tilton, health policy coordinator;
Cheryl Jaeger, majority professional staff; Eugenia Edwards,
legislative clerk; John Ford, minority counsel; Karen Folk,
minority counsel; and Jessica McNiece, minority staff
assistant.
Mr. Bilirakis. I call this hearing to order. I appreciate
the patience of the panelists and the audience. I would like to
thank our witnesses for taking the time to appear before the
subcommittee.
The Institute of Medicine's 1999 report, ``To Err is
Human,'' brought the frequency and devastating effects of
medical errors into public scrutiny. In the report the
Institute of Medicine estimates that an unbelievably high
number, between 44,000 and 98,000, of Americans die each year
as a direct result of potentially preventable mistakes.
During the 106th Congress, the American Nurses Association,
the Joint Commission on Accreditation of Health Care
Organizations, and U.S. Pharmacopeia testified before our
subcommittee about strategies for reducing medical errors. Once
again, we have the opportunity to hear from these
organizations.
Today's hearing provides our committee with evidence about
the successes the private sector has achieved in addressing
this issue. I am also pleased that the administration has taken
an active role in addressing patient safety. Last year
Secretary Tommy Thompson announced the release of $50 million
to fund 94 new research grants, contracts, and other projects
to reduce medical errors and improve patient safety.
In addition, President Bush's fiscal year 2003 budget
proposal includes a $10 million increase for patient safety
activities at the Food and Drug Administration and the Agency
for Health Care Research and Quality. The information presented
will be invaluable as we determine Congress's role, if any, in
addressing this problem.
I have always believed that not every problem in our
country requires action by the Federal Government. This hearing
will play an important role as we consider legislative
alternatives.
Again, I would like to thank our witnesses for appearing
before the subcommittee today, and I would ask at this point
unanimous consent that certain members of the panel who would
like to supplement their verbal or oral testimony with visual
presentations be allowed to do so, and that their time be
extended accordingly. Hearing no objection, that will be the
case, and I will yield to the ranking member, my friend, Mr.
Brown, for an opening statement.
Mr. Brown. Thank you, Mr. Chairman, for holding today's, I
hope, informative hearing. I would like to thank our
distinguished witnesses for joining us. Cardinal Health, Quest
Labs, JACO, Pharmacopeia have been working to reduce medical
mistakes, and they have important successes to share with the
subcommittee today, and we thank you for that.
I want to extend a special welcome to Jim Hethcox, Vice
President of Pharmacy Practice at Cardinal Health, and in my
home State of Ohio and in Dublin, Ohio. Cardinal has developed
a bar code technology to help ensure that patients receive the
proper dosage at the correct time. They have also developed
innovative packaging to help patients comply with their
prescribing instructions.
I am looking forward, too, to the testimony of Bonnie
Westra, a registered nurse. With the current critical shortage
of nurses, they have a unique perspective of how error
reduction programs are actually working.
The statistics, as we know, on medical errors are alarming.
Medical errors are the eighth leading cause of death in the
United States. Each year 90-some-thousand deaths are attributed
to these errors. Medical errors drain an estimated $29 billion
from the health care system every year, with 44 million
Americans uninsured. There is a gaping hole in Medicare, where
prescription drug coverage should be. There are unjustifiable
and unconscionable disparities in the health of minorities. We
don't have a cure for cancer and AIDS and heart disease, and on
and on. We don't have $1, let alone $29 billion, to burn.
According to an IOM report published 3 years ago, medical
errors are more often the result of systemic flaws, not
negligence on the part of individual health care providers. The
current system all too often leads to numerous errors that are
unique: Infections resulting from lapses in hand washing,
medication errors resulting from prescriptions difficult to
read, missed diagnoses, improper treatments, contaminated blood
products. Each of these types of errors calls for a different
solution.
It is considered an error if patients have difficulty
taking their multiple prescriptions, some with food, some
without, some every few hours, some only at night, and then
those patients are admitted into a hospital for failing to
comply with the medications' directions. These examples
highlight the flaws of the health care delivery system more
than they do the failures of an individual.
Two years ago, the Commerce Committee held a hearing to
examine the medical error problem highlighted in a report from
the Institutes of Medicine. At that time it was clear there
were no quick fixes to the problem of medical errors, but since
then both the private and the public sectors have made
remarkable progress in the development of products and services
aimed at reducing medical errors, as we have mentioned
Cardinal's a moment ago.
While the private sector is here today to share their
findings, I am disappointed that the administration is not here
to share how, for instance, the Agency for Health Care Quality
and Research at HHS is addressing this issue. They should be
here to share their findings.
Aside from that, Mr. Chairman, I am pleased again to hear
from our panelists. I hope this hearing adds to the momentum
that has been building and the apparent successes in reducing
medical errors. I thank the chairman.
Mr. Bilirakis. I thank the gentleman. Dr. Ganske, for an
opening statement.
Mr. Ganske. Thank you, Mr. Chairman. I think it is really
important to have this hearing. I appreciate the effort you and
the staff have put into this important issue. Prior to coming
to Congress, I was a reconstructive surgeon. So I am intimately
aware of the issue that we are talking about today.
I think it is important to start out by making a
distinction between a good result and a bad result and an
error, because it is inherent in human activity that sometimes
not everything goes perfect. Let me give you an example.
If a patient gets an infection, now that is a bad result.
Something unfortunate has happened, but was it an error? Maybe,
and maybe not, because infections can happen, despite the best
sterile technique. I mean, the skin is not a sterile organism,
for example. No matter how much you scrub it, there are still
going to be bacteria there.
Some operations take a long time, because they are very
complicated. We know, for example, that the longer an operation
goes on and you have an open wound, the higher the chance that
you may have an infection. So what is an acceptable infection
rate? Maybe it is half a percent or 1 percent for certain
procedures. Maybe if you are operating on the gut in an
emergency situation, doing everything right would still result
in a higher infection rate than that.
So I think it is important for the public to make a
distinction between a complication and an error. That is a
very, very important distinction. There are errors of
commission where you may do something wrong. There are errors
of omission where you haven't done something that you should.
There are errors in diagnosis, errors in treatment. There are
errors in process, errors in evaluation and management.
In the operating room, an error in process would be, for
instance, operating on the wrong extremity. So it will be
interesting to hear some ideas from our panelists on how we can
create processes and techniques to reduce the chance of those
errors occurring.
A simple way might be that in the operating room, or in the
pre-op area where the patient is awake, the surgeon is talking
to him, you pick up the hand that you are going to operate on
and you put an X in the palm, or there is a procedure to put a
red wrist band on the extremity that is going to be operated
on.
Another thing I always thought was important in terms of
making sure there weren't errors in the operating room was to
reduce the sort of pandemonium and chaos that can sometimes
occur. Operating rooms--I'm not saying that you can't have
music in the operating room. Sometimes some quiet, soothing
music is helpful, but sometimes some rock music and a lot of
people talking can be distracting.
So there are different things that you can, practically
speaking, do to reduce the chance of an error occurring. It
will be interesting to hear the comments of the different
panelists on this, but this is something that we should all be
concerned about.
In every human endeavor there are errors, but in every
human endeavor we strive to reduce the incidence of those
errors, and I am looking forward to the testimony today, and I
thank you, Mr. Chairman.
Mr. Bilirakis. I thank you, Dr. Ganske. You have been a
terrific addition to this committee because of the practical,
real world experience that you have, and I appreciate your
being here this morning. Ms. Capps for an opening statement.
Ms. Capps. Thank you, Mr. Chairman. I appreciate this
opportunity to review the progress that has been made in
reducing medical errors. After the 1999 Institute of Medicine
report was published, this committee held hearings to consider
its findings, and it is only appropriate that we now return to
the subject to find out what has changed.
I am looking forward to hearing the opinions of our
witnesses today regarding this important subject, and
understand that they will be focusing on the technologies and
the systems that health care providers can use to avoid medical
errors. I am eager to hear what they have to say, but I also
want us to be sure to look at the role of proper staffing in
avoiding medical errors.
I have been very pleased to work with Chairman Bilirakis,
ranking members Brown and Dingell, and several other members of
this committee to address the growing shortage of registered
nurses as one piece of this staffing issue. Five months ago, we
passed a version of my bill, the Nurse Reinvestment Act, and
the Senate has passed their own version of the same bill, and
since then we have been working to develop a final bill that
could be sent to the President's desk. This, I am convinced,
will at least help to address the topic of shortages, which can
be seen as a part of the issue around errors.
The nursing shortage is an increasing threat to patient
safety, and it is one of the causes for the medical errors we
are trying to address. We clearly have a shortage of nurses,
and the number of patients is not going down. In fact, we can
anticipate greater shortages and more and more patients in the
future.
This means that nurses, and other staff people as well, but
I am focusing now on nurses, are overworked and overstressed.
They are forced to do the work of two or three nurses on a
regular basis, and sometimes nurses are placed into jobs that
they do not have the training for, because there isn't a
properly trained nurse available to do that work. These are
conditions that are guaranteed to create serious medical
errors.
When nurses and other health professionals are tired and
frustrated, they are more apt to make mistakes. They are human.
We are all human, and the low morale that comes from these
mistakes and the workplace frustrations contribute to other
mistakes.
Unfortunately, we cannot just flip a switch and suddenly
have staffing where we need it. It takes a few years for a
nurse to complete training and enter the workforce. For some in
specialty positions, advanced clinical practices, it takes
longer than that, and that is why it is imperative to pass
nurse shortage legislation and get it signed by the President
and out into the communities soon.
A bill that provides better training through scholarships,
internships, and residencies and helps to foster better
management practices can help us to ease the shortage and also
to reduce medical errors. There are many steps we can take to
avoid more medical errors, perhaps limiting residents' work
hours, for example, but passing the Nurse Reinvestment Act soon
and getting it onto the President's desk is a good first step
to address these issues.
I have been pleased to work with you on this, Mr. Chairman.
As you know, we have talked about it incessantly, and I do look
forward to wrapping up this bill quickly. I yield back the
balance of my time.
Mr. Bilirakis. Amen to your comments. You and I met last
night on the nursing bill, and we plan to meet during this
hearing as soon as we can get somebody to come here to replace
us. Ms. Wilson for an opening statement.
Ms. Wilson. Thank you, Mr. Chairman. I look forward to
listening to the testimony and reviewing the testimony, and I
have no opening statement. Thank you.
Mr. Bilirakis. Ms. Eshoo for an opening statement.
Ms. Eshoo. Thank you, Mr. Chairman. Good morning to you and
to our ranking member, Sherrod Brown. This is an important
hearing, and I welcome it taking place.
I am concerned, because it has been a long time since the
Institute of Medicine released its report on this issue, and
Congress has yet to take steps to help reduce the number of
medical errors occurring in our country. So we have some work
to do.
Certainly, the report takes us, points us, in the direction
of--It gives us the information from which we need to take
action. The numbers from the 1999 report are really
astonishing. More than 44,000 Americans are dying every year
from medical errors, many of which could be prevented. We are
all familiar with the term ``the practice of medicine,'' and we
know that there isn't a human being, regardless of where they
hold their degree and how brilliant they are, that things can,
obviously, go wrong. It is the mark of humanity, but there are
many steps that can be taken by the Congress to help prevent
what the report tells us.
So that is why I welcome this hearing, and to the
distinguished panel that is here today, because obviously, we
can't act in a vacuum.
One of the key elements of any proposal is to reduce
medical errors. To reduce them, we have to have the access to
the technologies that are specifically designed for specific
purposes. Cardinal Health, represented here today, has a number
of companies and products that are dedicated to helping
hospitals and providers reduce their error rates.
I also think, and I am going to slide something in here,
Mr. Chairman, that they are not--hospitals are not going to be
able to afford to buy these technologies unless we do something
that helps them, because they are in a vise, hospitals across
the country, certainly in rural America but all over the
country. Hospitals are in a vise between the public
reimbursement systems and the private reimbursement systems.
So when the BBA Fix bill comes up, we need to keep--All of
these issues are linked with one another. They are not just
separate standing smokestacks. We really have to address them
as a whole. Automated dispensing and health care worker
identification are just two advanced mechanisms that can help
hospitals and providers safeguard against improper or mistaken
use of drugs or supplies.
As we rely more and more on a multitude of pharmaceuticals
and devices to treat diseases, it is important that we also
advance our ability to monitor the correct use of the products.
Lifesaving products such as drugs and devices should be just
that, lifesaving, not threatening.
Let us hear from our expert witnesses, and I am looking
forward to hearing from them today. Then I hope this committee,
which has distinguished itself in the past in so many different
areas to make a difference for our country, will take action on
the essence of the report and bring something forward to the
full committee and to the full House so that we can bring these
numbers down and really score a victory for the American
people.
Thank you, Mr. Chairman. I yield back.
Mr. Bilirakis. I thank the gentlelady.
[Additional statements submitted for the record follow:]
Prepared Statement of Hon. Chip Pickering, a Representative in Congress
from the State of Mississippi
Mr. Chairman, thank you for holding this hearing today regarding
medical errors. I look forward to the testimony from our panel of
witnesses. When one looks at the number of individuals that are
affected each year due to medical errors they find it astonishing.
Studies have shown that there are at least 44,000 Americans that die
each year due to medical errors and the number may be as high as
98,000. This is a problem that must be addressed.
In 1999, Congress reauthorized the Agency for Healthcare Quality
and Research within the Department of Health and Human Services as the
lead agency to improve healthcare quality, improve patient safety and
to expand access. We also gave the AHRQ the authority to conduct
research that will help us to better understand medical errors.
While Congress has not mandated a federal reporting system of
medical errors, there are already some voluntary and mandatory systems
in place. The Center for Disease Control in Atlanta operates a
voluntary reporting system known as the National Nosocomial Infections
Surveillance System. This system compiles data that reports on medical
errors that occur through hospital-associated infections. The CDC also
coordinates the National Immunization Program Vaccine Adverse Events
Reports System. This system is designed to report the rare adverse
effects that are associated with vaccinations.
At the Food and Drug Administration, healthcare professionals
report any adverse events that involve medical products to MedWatch.
MedWatch is a voluntary program that reports on the errors of medical
products. The FDA also administers the Biological Product Deviation
Reporting System. This system was developed in order for reports to be
given from licensed manufacturers of all biological products and
unlicensed registered blood establishments on deviations in
manufacturing.
Also, several private non-profit organizations have created
reporting systems that are committed to reducing the number of medical
errors. The Joint Commission on the Accreditation of Healthcare
Organizations encourages companies to maintain a process for
identifying, reporting, and analyzing medical errors.
There is no doubt that great strides have been taken among all in
the healthcare community to reduce the number medical errors. Again,
Mr. Chairman, I look forward to the discussion we are going to have
this morning and commend you once again for your efforts and commitment
to the quality of healthcare in our nation.
______
Prepared Statement of Hon. W.J. ``Billy'' Tauzin, Chairman, Committee
on Energy and Commerce
Thank you, Mr. Chairman for holding this important hearing to
discuss medical errors.
Patient safety is, and should always be, an important concern for
our committee. Government policies should always promote and encourage
America's companies to produce products and services that reduce the
incidents of consumer harm or error. This is not only sound public
policy, but good business sense. Competition drives innovation, and it
is this impetus that has made America the world leader in new solutions
to help people live longer and better.
Two years ago, the House Commerce Committee held a joint hearing
with the Committee on Veterans Affairs to focus on the problem of
medical errors. This hearing followed the release of the Institute of
Medicine's November 1999 report, To Err Is Human. In that report, the
IOM estimated that at least 44,000 Americans die each year as a result
of medical errors, and that the number may be as high as 98,000. If
accurate, medical errors cause a greater number of deaths than motor
vehicle accidents, breast cancer, or AIDS. Even more alarming, we may
or may not be properly accounting for all of the medical errors that
occur on a minute-to-minute basis or taking the appropriate steps to
reduce their occurrence.
Human error is, by definition, unavoidable. We may not be able to
achieve perfection, but we must strive to ensure that when a medical
error occurs, the harm it causes to a patient is minimized. Today, we
have an outstanding panel of witnesses who understand clearly that
patient safety is the bottom line for their businesses. They represent
companies which have a broad range of approaches to addressing the
medical error problem. What is most exciting is that these witnesses
represent merely a glimpse of some of the incredible collaborative
efforts underway within the health care community that are creating new
technologies and improving the delivery of services for patient safety.
Today, we have an opportunity to learn from the witnesses about the
steps their businesses and non-profit organizations have taken since
the publication of the IOM report. Though the recommendations of the
Institute of Medicine were numerous, they certainly gave both the
public and private sector a clear starting point for some serious
discussion of how to comprehensively achieve better patient safety.
Three of our five witnesses represent organizations that originally
testified before this committee two years ago. I am most interested to
hear from you all about the advances that have been made since then.
The federal government is an important player in our efforts to
improve patient safety. Our public policies directly affect the ability
of the private sector to conduct their business. The federal government
currently maintains and operates numerous reporting systems and
databases to help track medical errors and prevent their reoccurrence.
The federal government also champions research to evaluate and
determine the options available to address health care improvement. We
must constantly examine these programs to enhance their efficiency and
ensure that we are not trampling on the private sector's ability to
innovate. The private sector represents our best opportunity to reduce
the occurrence of medical error. We should ensure that any legislation
we advance emphasizes that point.
Today, I would also like to take a moment to recognize a true
leader in this field, John Eisenberg, former Director of the Agency for
Health Care Research and Quality who recently passed away. His tireless
determination and dedication to this issue will be sorely missed.
Thank you, again, Mr. Chairman for holding this hearing. It's nice
to take a break--albeit temporarily--from our work on Medicare and
focus on another important issue. We have so many priorities at this
Committee. I'm excited that we are addressing such an important issue.
______
Prepared Statement of Hon. Gene Green, a Representative in Congress
from the State of Texas
Thank you Mr. Chairman for holding this hearing today on strategies
for reducing medical errors.
In November of 1999, the Institute of Medicine released its eye-
opening report on medical errors.
In its groundbreaking report, To Err is Human, the IOM made us
painfully aware of the shortcomings in the area of patient safety.
According to some estimates, as many as 98,000 people die in any
given year from medical errors that occur in hospitals. That's more
than die from motor vehicle accidents, breast cancer, or AIDS.
The costs of preventable adverse events are staggering. The direct
and indirect costs of medical errors range from $17 billion to $29
billion. By any standard, that is far too much.
At a time when other industries are finding more efficient ways to
do things, the health care industry lags far behind.
As the IOM study points out, between 1990 and 1994, the U.S.
airline fatality rate was less than one-third the rate experienced in
mid century. In 1998, there were no deaths in the United States in
commercial aviation.
In health care, however, preventable injuries have been estimated
to affect between three to four percent of hospital patients.
We would never tolerate these statistics in any industry, be it air
travel or food safety, and there is no reason we should excuse the
health care industry.
Mr. Chairman, I am not condemning the hard-working health care
professionals who serve this nation every day. I know they are
committed, skilled individuals who do their best.
But it is abundantly clear that we can and should do better in this
area.
The Institute of Medicine recommended a number of options to help
reduce medical errors, such as the creation of a Center for Patient
Safety within the Agency for Health Quality and Research.
They also suggested a new system of reporting, and better use of
technological advancements.
And we certainly have seen, and will hear testimony, about how
these methods can improve patient safety.
Technological advances in recent years can help us substantially
reduce the number of medical errors.
For example, adverse drug events account for approximately $5.1
billion in costs each year. Almost one-third of these events are
entirely preventable.
Better utilization of existing technologies could help us reduce
these adverse drug events significantly.
I am happy to see a witness here from Cardinal Health Care.
I recently had the opportunity to learn more about Cardinal's Pixys
(Pick-sus) system at a demonstration in the Cannon Caucus Room, and I
was impressed by their product and the potential it has to reduce
errors.
I am also interested in the bedside verification and bar code
technology.
Those of us who remember the good-old-days when cashiers actually
keyed in the cost of groceries, know how much more efficient bar code
scanning is.
These are the kinds of time-tested technologies that could and
should be adapted on the larger scale throughout our health care
system.
I am also interested in the other witnesses testimony about their
approaches to improving patient safety.
I realize there is no single solution to our patient safety
problems, but I think we should consider all of our options, and am
pleased that we will have the opportunity to do that today.
Thank you Mr. Chairman, and I yield back the balance of my time.
______
Prepared Statement of Hon. John D. Dingell, a Representative in
Congress from the State of Michigan
Chairman Bilirakis, thank you for convening this hearing on
strategies to reduce medical errors and improve the quality of care for
all of America's patients. Two years ago, a report published by the
Institute of Medicine (IoM) changed the way we think about medical
errors. The report concluded that, most often, medical errors are
caused by flaws in the health care delivery system, and less often are
the fault of individual doctors, nurses, or other practitioners in the
health care industry. And the report said that medical errors can be
reduced or even eliminated by designing better systems.
Both the government and the private sector have embraced the
conclusion of the IoM report and begun to examine in earnest the
systems that lead to inadvertent mistakes. I would particularly like to
commend the late Dr. John Eisenberg in his role as head of the Agency
for Health Research and Quality. Dr. Eisenberg recognized that quality
health care is not just an abstract ideal, but an attainable goal that
can be reached through application of the best available science.
Through his vision and dedication, the agency became the Nation's
leader in the science of medical error reduction.
Today's witnesses will describe patient safety initiatives in the
private sector. Several will highlight how new technology can
dramatically decrease medical errors. Others will describe how
management philosophies from manufacturing industries can be applied to
health care. Finally, some will comment on how providers on the front
lines of the health care delivery system can translate these new
technologies and management philosophies into practice.
I would like to acknowledge the work of one additional organization
who is not a witness today, but has been highly instrumental in
mobilizing large purchasers of health care to promote patient safety.
General Motors, in conjunction with the ``Leapfrog Group,'' pioneered
the practice of rewarding health care providers that demonstrate
quality results. As the largest purchaser of health care in the
country, the Federal government should carefully study this example.
I look forward to the testimony of our distinguished panel and to
working with the Chairman on this important topic.
Mr. Bilirakis. We will now go to the panel of witnesses.
Your written statements are a part of the record, and we would
hope that you would supplement and complement them. I have
already asked for unanimous consent as far as the videos are
concerned. I understand that Mr. Hethcox has one. So why don't
we start off with you, sir.
Mr. James Hethcox is Vice President of Pharmacy Practice,
Cardinal Health, Inc. out of Dublin, Ohio, Mr. Brown's area,
and I would turn the clock on to 5 minutes at this point in
time. Please try to complete your oral statement within that 5
minute period of time, but then we will give you additional
time on the video. Thank you, sir.
STATEMENTS OF JAMES M. HETHCOX, VICE PRESIDENT, PHARMACY
PRACTICE, CARDINAL HEALTH, INC.; KENNETH W. FREEMAN, CHAIRMAN
AND CEO, QUEST DIAGNOSTICS INCORPORATED ON BEHALF OF THE
HEALTHCARE LEADERSHIP COUNCIL; DENNIS S. O'LEARY, PRESIDENT,
JOINT COMMISSION ON ACCREDITATION OF HEALTHCARE ORGANIZATIONS;
ROGER L. WILLIAMS, U.S. PHARMACOPEIA; AND BONNIE WESTRA,
AMERICAN NURSES ASSOCIATION
Mr. Hethcox. Mr. Chairman, Congressman Brown, and members
of the subcommittee. As stated, I am Jim Hethcox, Vice
President for Pharmacy Practice for Cardinal Health. Prior to
joining Cardinal, I was a pharmacy practitioner for 25 years in
hospitals ranging in bed size from 200 to 1,000 beds.
I want to thank the subcommittee for the opportunity to
testify regarding the products and services being developed by
the private sector to assist in reducing medication errors as
well as the obstacles the industry faces in broader adoption of
patient safety tools.
Cardinal Health is a comprehensive provider of health care
products and services. We provide product development,
manufacturing and packaging, as well as distribution,
operations and clinical improvement services. I am pleased to
have the opportunity to comment on two of our cutting edge
products that improve patient safety, specifically compliance
packaging for the outpatient setting and automated bedside
verification of medication administration in the inpatient
setting.
First, compliance packaging. Medication noncompliance--that
is, a patient failing to take his or her medication as
prescribed--is a major health problem and has been described as
America's ``other'' drug problem. In the general population,
rates of medication noncompliance range from 20 to 70 percent.
The issue is exacerbated among the elderly, as they take an
increased number of prescriptions and may have increasingly
compromised physiology. The average elderly patient takes 17 to
24 prescriptions a year. An AARP survey showed that 58 percent
of the elderly population makes errors when taking medications,
and nearly 10 percent of all Medicare hospital admissions are
the result of medication noncompliance. Furthermore, the cost
impact of noncompliance exceeds $100 billion per year.
Cardinal Health, a leader in pharmaceutical packaging
promotes compliance packaging to help reduce such medication
errors. Compliance packaging is a pre-packaged, ready to
dispense system used for a treatment cycle of a medication that
provides day and time reminders as well as patient education
information to help patients take their medications correctly.
We believe that compliance packaging can help reduce errors
in the outpatient setting, thus enhancing the probability of
positive outcomes. Moreover, compliance packaging could save up
to 1,700 hours a year in a busy retail pharmacy; this is an
important benefit, given the shortage of pharmacists now facing
this country.
The elderly are especially at risk of medication
noncompliance. In 1999, the Congress directed the Department of
Health and Human Services to award a grant to study the
benefits of compliance packaging and improving seniors' ability
to take their drugs as prescribed. That study will commence
next month.
Turning to automated medication dispensing and bedside
verification: Up to 30 percent of all hospitalized patients
experience an adverse drug event, and research suggests that up
to one-third of these are preventable. Patients who experience
in-hospital medication related errors often require 2 to 5
additional days of hospitalization at a cost of $2,000 to
$5,000 per admission.
Most errors are the result of breakdowns in the system of
care. With approximately 3.75 billion drug administrations made
annually to patients in hospitals, with an average of 20 steps
per admission, the opportunity for things to go wrong are
significant.
Pyxis, a Cardinal Health company, has revolutionized
medication distribution within hospitals through development of
an automated medication dispensing systems. These systems have
greatly decreased the steps in the medication use process, and
thus have improved safety.
A next step is to move medication related patient safety
technologies directly to the patient's bedside. Such
technology, specifically bedside verification, uses barcode
scanning at the point of administration to ensure that the
right patient receives the right medication in the right dose
by the right route at the right time.
With the permission of the chairman, I have a short video
of the Pyxis Veri5 system that I would like to show at the end
of my testimony to demonstrate this technology.
The most significant obstacle inhibiting adoption of this
exciting technology is the lack of barcodes on medication.
Approximately 30 percent of unit dose medications bear
manufacturer printed barcodes. We are encouraged that the FDA
has indicated intent to publish a notice of proposed rulemaking
on this issue. We believe standards developed in this area must
be done in a thoughtful and cost effective manner, ensuring
patients have timely access to this important patient safety
technology.
Knowing that we share a common commitment to improve
patient safety, I would like to leave you with three concluding
thoughts.
One, the provision of patient care is indeed complex. There
is no simple silver bullet or quick fix. Two, nor there is a
cookie cutter solution for all organizations. Each environment
has a unique set of needs, challenges, and capabilities.
Finally, the road to patient safety will be an ongoing work in
progress. Given health care's resource constraints, a logical
and planned progression in which the work of each tomorrow will
build upon a solid foundation built by each preceding today
should serve us well.
Now I would like to let you hear directly from the
practitioners currently using our bedside verification
technology, and I thank you for your interest and attention.
[The prepared statement of James M. Hethcox follows:]
Prepared Statement of Jim Hethcox, Vice President, Pharmacy Practice,
Cardinal Health, Inc.
Mr. Chairman and Members of the Subcommittee: I am Jim Hethcox,
Vice President of Pharmacy Practice at Cardinal Health. I want to thank
the Subcommittee for holding this very important hearing on medical
errors and for receiving testimony on products and services developed
by the private sector to assist in reducing these errors and obstacles
the industry faces in broader adoption of these and other patient
safety tools.
Cardinal Health is a comprehensive provider of products and
services supporting the health care industry. The company has over
50,000 employees serving the hospital, retail pharmacy, and
manufacturing segments of healthcare. Our purpose is to provide
essential support that helps our customers succeed in their respective
roles within patient care. The company's mission is to be an integral
partner in the delivery and improvement of healthcare. We act as a
vital link between manufacturers and providers of patient care,
providing product development, manufacturing, and packaging services as
well as distribution, operations, and clinical improvement services.
Our products and services span the continuum of care, which includes
acute, subacute, long-term, and outpatient care settings as well as the
home. Cardinal Health is a leader in the health care industry in
developing and delivering an unparalleled array of cutting-edge
products and services that focus on improving medication safety.
Cardinal Health is committed to helping improve patient safety, and
I am pleased to have the opportunity to comment on two of the many
products and services provided by various companies within Cardinal
Health that help to improve patient safety and reduce medical errors.
The first is compliance packaging for the outpatient setting, and the
other is automated bedside verification of medication administration in
the inpatient setting.
compliance packaging
Medication non-compliance is simply a patient failing to take his/
her medications as prescribed and represents a major health problem. In
fact, it is such a common occurrence that the National Council on
Patient Information and Education designated non-compliance as
``America's other drug problem.'' In the general population, rates of
medication non-compliance range from 20 to 70 percent. Most of the
Members of this Committee as well as the other people in this room are
probably personally familiar with the challenges of taking prescription
medications correctly. This issue is exacerbated among the elderly, as
they take an increased number of prescriptions and may have
increasingly compromised physiology.
It is estimated that the average elderly person takes 17-24
prescriptions a year.<SUP>1</SUP> An American Association for Retired
Persons survey showed that 58 per cent of the elderly population makes
errors when taking their medications.<SUP>2</SUP> Nearly 10 per cent of
all Medicare hospital admissions are reported to be the result of
medication non-compliance.<SUP>3</SUP> Furthermore, it has been
estimated that the annual economic cost of non-compliance exceeds $100
billion per year.<SUP>4</SUP>
---------------------------------------------------------------------------
\1\ Kreling, David H., Mott, David A., Wiederholt, Joseph B. of the
University of Wisconsin School of Pharmacy and Lundy, Janet, Levitt,
Larry of The Kaiser Family Foundation, Prescription Drug Trends: A
Chartbook Update. November 2001.
\2\ Prescription Drugs: A Survey of Consumer Use, Attitudes and
Behavior. American Association of Retired Persons, Washington, D.C.,
1984.
\3\ A Study of Long-Term Care in Oregon with Emphasis on the
Elderly. Oregon Department of Human Resources, March 1981.
\4\ Noncompliance with Medications: An Economic Tragedy with
Important Implications for Health Care Reform. The Task Force for
Compliance, April 1994.
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Cardinal Health is a leading provider of diversified pharmaceutical
packaging services and promotes the use of compliance packaging to help
reduce medication errors among consumers. Compliance packaging is a
prepackaged, ready-to-dispense system that is used for a treatment
cycle of a medication and that provides day and time reminders as well
as patient education information to facilitate and motivate patients to
take their medications correctly. Such packaging provides for the day
and time for administration to be clearly identified on the package
directly beside each dose. For example, a patient ``punches out'' the
tablet from a blister package and takes the correct dose on the correct
day at the correct time. An example of this type of compliance
packaging is the packaging commonly used for birth control pills.
This type of compliance packaging encourages a patient to continue
to take a medication to the end of the originally prescribed regimen
and eliminates the need for patients to transfer their medications to
other compliance containers. It aids patients in remembering when to
take their medication and readily identifies when they have already
taken a particular dose.
We believe that compliance packaging can help reduce errors of
under- and over-consumption in the outpatient setting. When patients
take prescription medications correctly at home, they are more likely
to experience positive therapeutic outcomes. Studies have shown that
compliance-improving programs have a cost-benefit ratio as high as
1:14.<SUP>5</SUP> When properly used, compliance packaging can help
physicians and pharmacists provide standardized medication instructions
in a minimum amount of time. A study conducted at Michigan State
University estimated that compliance packaging could save up to 1,700
hours a year in a busy retail pharmacy.<SUP>6</SUP> This is especially
important given the pharmacist shortage now facing this country.
---------------------------------------------------------------------------
\5\ Smith, M. The Cost of Non-Compliance and the Capacity of
Improved Health Care Costs. In Improving Medication Compliance,
Proceedings of a Symposium. N&I Pharmaceutical Council, 1984.
\6\ Lockhart, Hugh E., Twede, Diana, Thomas, Dena Briggs, Kokikar,
Manisha P. Comparative Cost Study: Packaging of Solid Oral
Pharmaceutical Dosage Forms in Bulk and in Unit Dose Blisters. Michigan
State University School of Packaging, April 1994.
---------------------------------------------------------------------------
We believe that compliance packaging can help decrease or eliminate
the following types of non-compliance issues:
<bullet> Patients taking incorrect doses
<bullet> Patients taking medication at the wrong time
<bullet> Patients forgetting one or more doses
<bullet> Patients receiving unclear or small, unreadable instructions
As discussed previously, the elderly are especially at risk from
medication non-compliance because of the number of prescription and
over-the-counter medications taken in a day and the complexity
resulting from different instructions on how to take each medication.
In 1999, the Congress recognized the need to address this very
important issue by directing the Department of Health and Human
Services to award a grant to perform a study to determine the benefits
of compliance packaging. The formal study will commence next month led
by The Ohio State University, The University of Arizona, and Brigham
and Women's Hospital to further research the issue of compliance and
how packaging can improve seniors' ability to take their drugs as
prescribed.
The study will monitor 300 Medicare patients for one full year,
half receiving their medication in traditional prescription vials and
half receiving their medication in a new, innovative ``pill calendar''
compliance package. Both compliance and clinical indicators will be
monitored.
automated medication dispensing and bedside verification
Cardinal Health recognizes that many medication errors that occur
in inpatient settings are indeed preventable. Results from several
studies suggest that the incidence of adverse drug events (ADEs) ranges
from 1 to 30 percent of all hospitalized patients, depending on the
broadness of the ADE definition used. Research shows that up to one-
third of these adverse drug events are preventable.<SUP>7</SUP> Many of
these preventable events are associated with significant rates of
morbidity and mortality and have a significant impact on hospital
costs. Patients who experience in-hospital, medication-related errors
often require 2-5 additional days of hospitalization at an additional
cost of $2,000-$5,000 per admission.<SUP>8</SUP>
---------------------------------------------------------------------------
\7\ Bates, DW, Cullen, DJ, Laird, N, et al. Incidence of Adverse
Drug Events and Potential Adverse Drug Events: Implications for
Prevention. Journal of the American Medical Association, 1995;
274(1):29-34.
\8\ Bates, DW, Spell, N, Cullen, DJ, et al. The Costs of Adverse
Drug Events in Hospitalized Patients. Adverse Drug Events Prevention
Study Group. Journal of the American Medical Association, 1997;
277(4):307-11.
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Most errors are the result of one or more breakdowns in the system
of care. It has been estimated that there are on average 20 steps
involved in the medication-use process.<SUP>9</SUP> When you consider
that approximately 3.75 billion drug administrations are made annually
to patients in hospitals, with 20 steps per administration, the
opportunities for things to go wrong are significant.
---------------------------------------------------------------------------
\9\ Leape, LL. The Health Profession's Responsibility for Reducing
Adverse Drug Events: Improving the Quality of the Medication Use
Process. Escovitz, A, Pathak, DS, Schneider, PJ (eds). New York:
Pharmaceutical Products Press. 1998:109-134.
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Errors in the medication-use process also can occur in long-term
care settings. Indeed, the risks might be greater in these settings
because the patients usually receive a greater number of drugs, and
there is a limited presence of on-site physicians and pharmacists to
help clarify medication orders.
Pyxis, a Cardinal Health company, is the leading provider of
automated medication- and supply-dispensing systems for hospitals and
other healthcare facilities. Pyxis has revolutionized the way
medications are distributed within these facilities. Resembling a
network of ATM machines, the technology is a point-of-care,
computerized system that automates the distribution, management, and
control of medications within hospitals and other facilities. It allows
a pharmacist to perform safety and quality checks and approve
medication orders electronically. Nurses gain immediate access to drugs
from the point-of-care cabinets on the nursing unit. The drugs in these
cabinets are packaged as unit-dose packages (i.e., a single dose per
package) and are placed in individual compartments in the cabinet. In
order to access medications, the nurse must first authenticate his or
her identity.
While this technology has greatly decreased the number of steps in
the medication-use process in the hospital and thus has significantly
improved safety, our hospital customers have been clamoring for even
more patient protections in the medication-use process. They want to
ensure that the right patient is getting the right medication in the
right dose by the right route at the right time.
This can be accomplished by utilizing bar code-scanning technology
at the point of administration, i.e., at the patient's bedside, to
verify administration of the proper medication. This verification is
accomplished through the use of bar codes on medication packages, the
patient's hospital identification bracelet, and the nurse's name badge.
Once the nurse obtains the medication for a patient, a bar code on the
unit-dose medication package is scanned with a hand-held device. The
nurse then scans the bar code on the patient's bracelet and the bar
code on his or her name badge. A rules-driven software program hosted
on a computer verifies that the right patient is receiving the
appropriate medication. If there are any safety concerns such as a
wrong drug, dosage, etc., an alert is presented immediately notifying
the nurse of the problem and thus helping to prevent an error.
This new technology is important to patients as well as healthcare
providers. If the Chairman would allow, I have a short video of the
Pyxis Veri5SM system that I would like to play at the end of my
testimony to demonstrate how this technology works.
Such bedside, medication-verification products have only been on
the market as a complete system for approximately two years. Hospitals
choosing to implement this technology must invest in the technology
itself as well as a radio-frequency infrastructure and then train their
staff. However, the most significant obstacle that inhibits the
adoption rate for this exciting technology is the lack of bar codes on
unit-dose medications. Presently, approximately 30 percent of the unit-
dose medications have manufacturer-printed bar codes. This means that
hospitals must either pay a third-party vendor to repackage their unit-
dose medications with bar code labeling or invest in capital equipment
to repackage and bar code the unit-dose medications within the
hospital. The first of these alternatives drives additional operating
costs while the second alternative requires a capital investment plus
the expense of precious staff time to operate the equipment. Further,
current Food and Drug Administration (FDA) and Drug Enforcement
Administration (DEA) regulations place constraints on repackaging and
relabeling of unit-dose medications. More specifically, third-party
vendors as well as hospital systems are constrained in packaging unit-
dose medications at one facility for transfer to other hospitals, even
to hospitals within the same system. This further impedes efficient use
of both capital and human resources.
We were very encouraged to see that the FDA has indicated an intent
to publish a notice of proposed rulemaking on the issue of bar coding
of pharmaceuticals. Development of a uniform standard for the bar
coding of unit-dose medications used within the institutional setting
would be extremely helpful. However, this must be done in the most
cost-effective manner possible for both providers and pharmaceutical
manufacturers. Cardinal Health recognizes that health care costs
continue to increase, and if the regulations are too complex or rigid,
we may not only increase costs inappropriately but also unintentionally
delay the implementation of this important safety initiative.
Cardinal Health also sees a tremendous potential for utilizing
automated medication dispensing equipment and bedside verification
tools in nursing homes. Given the elderly population and the high use
of pharmaceuticals in this setting, the patient safety advantages could
be most significant. However, the DEA currently prohibits ``floor
stock'' in nursing homes, instead requiring that drugs be prepackaged
for each patient for one month at a time. While this site of care
closely mirrors a hospital setting, it is treated through regulations
as an outpatient setting. The current distribution system has some
advantages, but it also creates a great deal of waste and
inefficiencies. The DEA published a concept paper on the issue of
automated dispensing equipment in nursing homes over a year ago. We
would encourage additional attention to this issue. Technology has
advanced greatly over the past several years and could now accurately
inventory and distribute medications in a safe and effective manner so
as to improve the administration of medications within the nursing home
setting.
Again, I appreciate the opportunity to testify about just two of
the innovative patient safety tools that Cardinal Health provides to
help ensure medications are used safely and appropriately. I would be
pleased to answer any questions the Committee Members may have
regarding my testimony. Thank you.
Mr. Bilirakis. Thank you, sir. Let's see. We will dim the
lights and hope that everything works.
[Video shown.]
Video Voice. What Veri5 affords us is the ability to take
barcoding to the bedside, whereby the nurse, the drug and the
patient all----
Mr. Bilirakis. Volume? Okay, we have a problem.
Video Voice. Very quickly, they recognized the benefit of
being able to feel more assured that that drug that they were
given was, in fact, the drug intended for that patient.
Mr. Pasque. One of the reasons that we chose this product
was Pyxis' history of support in these types of products, and
Veri5 has not failed to meet our expectations in this area.
Ms. Jewell. The Pyxis Veri5 is a plus to have on your
nursing unit in the hospital, I believe, because it shows the
nurses that the hospital has taken an initiative to move
forward.
Ms. Bovie. I think the single most important benefit that
this has brought to the patients at East Jefferson as well as
our nursing staff is patient safety.
Ms. April. We have had several near misses that really made
nurses say, wow, if I did not have this piece of machinery,
Pyxis Veri5, I would have given this medication, and it would
have been an error.
Ms. Bovie. On this post-partal unit where we have the
device working, we have seen a total reduction from--I think
our numbers were like five and six medication errors a month,
now down to nothing. In the area of quality control, Pyxis
Veri5 is the manager's dream. It certainly takes an awful lot
of time off my plate in being able to have the pharmacist and
his staff generate reports for us.
Mr. Pasque. One of the advantages that we can see, having
brought Veri5 live on our initial unit, is the assistance that
it will give us in meeting the regulatory agencies such as
Joint Commission, those requirements and regulations.
Ms. Bovie. We can track everything from what we are now
calling near misses in our medication process team, house-wide
medication process team, those times when you go to a bedside
and you go, oops, that medicine is not for you or, oops, yes,
you do have an allergy to that. This device prints out a
report. They go into the Pyxis med station and are able to vend
that medication, and then take that from that point to a higher
safety level. Now they can actually take that to the bedside
when they are in a hurry and trying to accomplish all of those
other things that nursing wants us to do. In the end, it saves
time, because now you don't have nurses chasing down medication
errors.
Ms. April. I think this would be an excellent marketing
tool to retain and recruit new nurses.
Ms. Jewell. I would have to say, short sentence, Pyxis
Veri5 improves patient safety.
Ms. Bovie. It is patient safety, and you either want your
patients to be safe or not, your choice.
Mr. Hethcox. Thank you.
Mr. Bilirakis. Thank you. Does that complete your
presentation?
Mr. Hethcox. Yes, sir.
Mr. Bilirakis. Thank you very much.
Ken Freeman is the Chairman and CEO of Quest Diagnostics
Incorporated. He is here on behalf of the Healthcare Leadership
Council. Mr. Freeman, please proceed, sir.
STATEMENT OF KENNETH W. FREEMAN
Mr. Freeman. Mr. Chairman, thank you for the opportunity to
speak with you this morning about a subject near and dear to my
heart, improving patient safety in America.
I am Chairman and Chief Executive Officer of Quest
Diagnostics, the Nation's leading provider of diagnostic
testing, information, and services. We operate 30 full-service
laboratories across the country and in Mexico and the U.K., as
well as more than 1,350 conveniently located patient service
centers where doctors send patients to have specimens
collected, employing more than 30,000 people.
Today I am testifying on behalf of Quest Diagnostics as
well as the Healthcare Leadership Council, or HLC. HLC is a
coalition of chief executives from all disciplines within the
health care system that meets to jointly develop policies,
plans and programs to achieve our vision of an effective 21st
century health care system. I will briefly describe the HLC's
patient safety initiative and then describe what my company,
Quest Diagnostics, is doing to reduce errors, thereby improving
quality and safety.
The Healthcare Leadership Council's Chief Executive Task
Force on Patient Safety was created so that all sectors of the
health care industry could work together to help elevate public
confidence in the safety of the Nation's health care system.
HLC members have been active in seeking to improve safety for a
long time, and their efforts represent a broad range of ongoing
programs. I have attached to my statement a brief description
of some of these programs, which I would like to submit for the
record.
Mr. Bilirakis. Without objection.
Mr. Freeman. Thank you. Coming from all facets of health
care, each HLC member company is addressing different safety
needs in the health care system, while adhering to a common set
of guiding principles. For example, we believe that solutions
should be developed collaboratively and with senior executive
responsibility and leadership. If the CEO isn't the most
passionate advocate of a patient safety initiative, it simply
will not happen.
We believe that a holistic quality assessment system must
be developed and adopted for use in health care, because errors
are caused by bad processes, not bad individuals. Improving
quality requires that we improve processes, based on facts and
data that are not always easy to collect. Safe practice
standards should be evidence based and appropriately flexible.
Again, we must analyze the data to identify ways to improve
practice standards, the processes, that are causing the errors
themselves. Finally, HLC members strive to establish a culture
of awareness, not blame, to drive sharing information about
health care errors in an open manner. It all starts with
acknowledging the opportunity for improvement.
At my own company, Quest Diagnostics, we have incorporated
these concepts into our own ``Six Sigma'' initiative to help
take us to the next level in improving quality and safety. The
Six Sigma approach has paid dividends for countless
manufacturing companies during the past 20 or more years,
including General Electric, Texas Instruments, and Motorola.
We are the first major company in health care services to
pursue Six Sigma and have been underway for more than 2 years.
Six Sigma is already changing Quest Diagnostics, and I am
absolutely convinced that it will ultimately change the world
of health care quality and safety for the better, forever.
During today's hearing, you will learn about many
fascinating and important technology solutions that will reduce
errors and improve safety, but technology can only be as
effective as the processes that employ it. The Six Sigma
approach is a philosophy and a type of analytic thinking that
can permeate an organization and drive behavioral change.
Quality, safety, effectiveness and efficiency go hand in hand.
Improving quality and safety is not only a moral imperative for
us. It also makes solid business sense.
We have made a significant investment to provide foundation
training for virtually all of our employees. We have
extensively trained almost 200 Six Sigma experts that are
called ``Black Belts.'' These experts are leading more than 200
distinct defect reduction projects, with several dozen having
been completed.
Six Sigma is a statistical measure representing virtual
perfection, defined as 99.9997 percent quality, or no more than
3.4 errors per million opportunities. Our pursuit of Six Sigma
quality is in its early stages, and we also have much more to
achieve, but we are making great progress.
One of our most successful Six Sigma projects has focused
on improving the effectiveness of our specimen handling process
to reduce the number of misplaced specimens for testing. When
we started, this process already reflected a high level of
quality. Now, in our business units that have implemented the
new process, it nears perfection.
In another Six Sigma project we collaborated with hospital
customers to reduce specimen collection errors that were
causing nurses to re-draw blood from premature infants in
neonatal intensive care units. These errors delayed diagnoses
and subjected fragile, tiny patients to needless trauma. The
root cause or reason was that the ICU nurses had never been
properly trained in sample collection. Designing and
implementing a simple training course to standardize the best
procedures for drawing specimens made an enormous difference
for premature infants and their families.
In another Six Sigma project we developed a new
standardized medical report using the Six Sigma process,
starting by listening to the voices of our physician clients.
The report is easier to read, lets a doctor identify abnormal
results more readily, and shortens the time required to review
reports, reducing the likelihood that a doctor will
misinterpret a test result.
We provide a critical health care service. Diagnostic test
results drive more than 70 percent of health care decisions,
but represent only about 4 percent of total health care
spending in the U.S. Every day, doctors and hospitals order
diagnostic tests to diagnose, treat or monitor the treatment of
millions of patients; tests that are performed by the Nation's
10,000-plus independent and hospital laboratories. Early
detection not only saves lives, it also saves money.
There is no looking back. The patient quality movement is
gaining momentum among health care services providers. More
companies and institutions are starting to discuss quality
improvement in health care, and it is about time. This is the
mega-trend that we collectively must act on, for the sake of
patients.
In closing, I am confident that together the health care
industry, including my fellow members of the Healthcare
Leadership Council, is rising to the challenge, recognizing the
opportunity to drive quality improvement, and taking action by
measuring defects and analyzing and improving the many
processes that cause them. This is the right thing to do for
patients and their families, and it is also good business
practice.
Once again, Mr. Chairman, thank you for the opportunity to
speak with you this morning.
[The prepared statement of Kenneth W. Freeman follows:]
Prepared Statement of Kenneth W. Freeman, Chairman and CEO, Quest
Diagnostics Incorporated on Behalf of Healthcare Leadership Council
Mr. Chairman, thank you for the opportunity to speak with you this
morning about a subject near and dear to my heart--improving patient
safety in America.
I'm Chairman and Chief Executive Officer of Quest Diagnostics, the
nation's leading provider of diagnostic testing, information and
services. We operate 30 full-service laboratories across the country
and in Mexico and the U.K., as well as more than 1,350 conveniently
located patient service centers, where doctors send patients to have
specimens collected, employing more than 30,000 people.
Today I am testifying on behalf of Quest Diagnostics as well as the
Healthcare Leadership Council, or HLC. HLC is a coalition of chief
executives from all disciplines within the healthcare system that meets
to jointly develop policies, plans and programs to achieve our vision
of an effective 21st century healthcare system. I will briefly describe
the HLC's patient safety initiative and then describe what my company--
Quest Diagnostics--is doing to reduce errors, thereby improving quality
and safety.
The Healthcare Leadership Council's Chief Executive Task Force on
Patient Safety was created so that all sectors of the healthcare
industry could work together to help elevate public confidence in the
safety of the nation's healthcare system. HLC members have been active
in seeking to improve safety for a long time and their efforts
represent a broad range of ongoing programs. I have attached to my
statement a brief description of some of these programs, as well as
HLC's principles on patient safety, which I would like to submit for
the record.
Coming from all facets of healthcare, each HLC member company is
addressing different safety needs in the healthcare system, while
adhering to a common set of guiding principles. For example, we believe
that solutions should be developed collaboratively and with senior
executive responsibility and leadership. If the CEO isn't the most
passionate advocate of a patient safety initiative, it simply will not
happen.
We believe that a holistic quality assessment system must be
developed and adopted for use in healthcare, because errors are caused
by bad processes, not bad individuals. Improving quality requires that
we improve processes, based on facts and data that are not always easy
to collect. Safe practice standards should be evidence-based, and
appropriately flexible. Again, we must analyze the data to identify
ways to improve practice standards--the ``processes''--that are causing
the errors. Finally, HLC members strive to establish a culture of
awareness--NOT blame--to drive sharing information about healthcare
errors in an open manner. It all starts with acknowledging the
opportunity for improvement.
At my own company, Quest Diagnostics, we have incorporated these
concepts into our own Six Sigma initiative to help take us to the next
level in improving quality and safety. The Six Sigma approach has paid
dividends for countless manufacturing companies during the past twenty
or more years, including General Electric, Texas Instruments, and
Motorola.
We are the first major company in healthcare services to pursue Six
Sigma, and have been underway for more than two years. Six Sigma is
already changing Quest Diagnostics, and I am absolutely convinced that
it will ultimately change the world of healthcare quality and safety
for the better, forever.
During today's hearing, you will learn about many fascinating and
important technology solutions that will reduce errors and improve
safety. But technology can only be as effective as the processes that
employ it. The Six Sigma approach is a philosophy and a type of
analytic thinking that can permeate an organization and drive
behavioral change. Quality, safety, effectiveness and efficiency go
hand-in-hand. Improving quality and safety is not only a moral
imperative for us, it also makes solid business sense.
We have made a significant investment to provide foundation
training for virtually all of our employees, and we have extensively
trained almost 200 Six Sigma experts called Black Belts. These experts
are leading more than 200 distinct defect-reduction projects, with
several dozen having been completed. Six Sigma is a statistical measure
representing virtual perfection, defined as 99.9997% quality, or no
more than 3.4 errors per million opportunities. Our pursuit of Six
Sigma quality is in its early stages and we also have much more to
achieve. But we are making great progress.
One of our most successful Six Sigma projects has focused on
improving the effectiveness of our specimen-handling process, to reduce
the number of misplaced specimens for testing. When we started, this
process already reflected a high level of quality. Now, in our business
units that have implemented the new process, it nears perfection.
In another Six Sigma project we collaborated with hospital
customers to reduce specimen collection errors that were causing nurses
to re-draw blood from premature infants in neo-natal intensive care
units. These errors delayed diagnoses and subjected fragile, tiny
patients to needless trauma. The root cause or reason was that the ICU
nurses had never been properly trained in sample collection. Designing
and implementing a simple training course to standardize on the best
procedures for the draw made an enormous difference for premature
infants and their families.
In another Six Sigma project we developed a new standardized
medical report using the Six Sigma process--starting by listening to
the voices of our physician clients. The report is easier to read, lets
a doctor identify abnormal results more readily, and shortens the time
required to review reports, reducing the likelihood that a doctor will
misinterpret a test result.
We provide a critical healthcare service. Diagnostic test results
drive more than 70% of healthcare decisions, but represent only about
4% of total healthcare spending in the U.S. Every day, doctors and
hospitals order diagnostic tests to diagnose, treat or monitor the
treatment of millions of patients--tests that are performed by the
nation's 10,000-plus independent and hospital laboratories. Early
detection not only saves lives, it also saves money.
There is no looking back. The patient quality movement is gaining
momentum among healthcare services providers. More companies and
institutions are starting to discuss quality improvement in healthcare.
And it's about time--this is the megatrend that we collectively must
act on--for the sake of patients.
In closing, I am confident that together the healthcare industry,
including my fellow members of the Healthcare Leadership Council, is
rising to the challenge, recognizing the opportunity to drive quality
improvement, and taking action by measuring defects and analyzing and
improving the many processes that cause them. This is the right thing
to do for patients and their families, and it is also good business
practice.
Once again, thank you for the opportunity to speak with you this
morning.
Patient Safety in the Health Care System
hlc statement of principles
The Healthcare Leadership Council's Chief Executive Task Force on
Patient Safety was created so that all sectors of the health care
industry could work together to help elevate public confidence in the
safety of the nation's health care system. We are accomplishing this by
uniting behind a self-initiated protocol for addressing patient safety
in the health care system responsibly, positively, and tangibly. The
HLC task force is guided by the following principles:
1. Solutions should be developed collaboratively and with executive
responsibility and leadership. A zero error medical environment
will require devoted, thoughtful and creative collaboration of
ALL STAKEHOLDERS: Care givers must increase awareness of the
potential for errors, administrators must facilitate systems of
improvement, patients must be committed to complying with
treatment programs, industry executives must make patient
safety improvement a declared and serious aim by establishing
programs with defined executive responsibility, and lawmakers
and regulators must resist mandates that could stifle
innovative problem solving.
2. A holistic quality assessment system must be developed and adopted
for use in health care. Individuals are not the true source of
errors in health care or any other industry. Systemic review of
processes, practices and policies to uncover sources of error
so the source of those errors can be eliminated is essential
for improving safety in the health system. The health care
system should incorporate the lessons learned in other
industries that have greatly reduced their error rates.
3. Safe practice standards should be evidence-based, flexible and
feasible. Nationally recognized safe-practice standards should
be developed only through analysis of conclusive data on broad-
based effectiveness and feasibility, and should consider
evolving science. In addition to recognizing broad-based safe
practices, health care organizations should be encouraged to
and should be recognized for adopting tailored safe practice
programs unique to their specific risk points, specialties, and
patient populations.
4. Healthcare organizations, lawmakers, and other policy officials
should support the automation of patient safety systems to the
greatest extent possible. The Institute of Medicine is urging a
new generation of patient safety systems that are automated,
information system-based, and technologically driven. A
voluntary health system information technology infrastructure
should be encouraged and facilitated as broadly and rapidly as
possible to help reduce incidence of human error in the
practice of medicine.
5. Establish a culture of awareness--NOT blame--to drive health care
errors into the open. Improving patient safety depends heavily
on the ability to collect and analyze patient safety data, and
to use that information to develop safer systems. Laws that
perpetuate litigation are antithetical to the goal of
transforming medical adverse events and ``near misses'' to
permanent and pervasive systems improvements. Lawmakers should
carefully consider any new laws or regulations that could
actually do damage to the current health care system by making
errors and ``near misses'' even harder to identify. Peer review
protections should be instituted to protect organizations from
the fear of litigation which will prevent the sharing of
information.
6. A system of incentives is the key to patient safety. Using positive
incentives to encourage health care organizations and all care
providers to swiftly report health care delivery problems and
to develop processes and procedures to prevent further errors
in the area is the key to improving the safety of health care
system.
7. Focus on prevention instead of errors. Instead of devoting major
efforts to medical errors after the fact, develop a system
focused on studying near misses, to prevent adverse events in
the first place. This focus should be firmly impressed early on
in graduate medical education programs as well as training
programs for all types of health care professionals.
8. Consider the larger context. The cause of--and solutions for--
adverse medical events must be considered in full context
beyond the individual incidents that result in medical errors:
<bullet> A hyper-regulated health care environment is not conducive
to patient safety. Coping with more than 111,000 pages of
complex Medicare rules, guidelines and instructions reduces the
amount of time and attention left for providers to focus on
their patients.
<bullet> A litigious health care environment is not conducive to
the promotion of awareness and information sharing necessary to
understand and avoid medical errors.
<bullet> A price-controlled health care environment reduces the
ability for health care organizations and systems to implement
the necessary technology that can positively affect patient
safety.
Members of the Healthcare Leadership Council have been leaders in
developing innovations to improve safety within the health care system.
The following illustrates a subset of patient safety initiatives
underway at a few HLC member companies and organizations.
ABBOTT LABORATORIES
Abbott is helping to reduce medication errors through continued
innovation in drug products. Abbott helped pioneer the availability of
premixed solutions and prefilled syringes to minimize mixing and
handling errors. Abbott also has developed numerous design and safety
improvements for medication administration, including a pre-filled bar-
coded syringe which automatically programs infusion pumps, helping to
avoid medication errors caused by manual programming. Abbott also
develops and continually improves products that protect against
needlestick injuries.
In addition, Abbott has a error-reducing label enhancement program
that includes color coding to help differentiate between products,
printing on the backside of IV containers to ensure clinicians see all
appropriate information, and machine readable industry standard bar
codes on unit-of-use products.
Using Abbott's own clinical nurse consultants and partnerships with
independent third parties, Abbott's support has made it possible for
hundreds of health care professionals to complete continuing medical
education programs developed by Abbott in cooperation with the
Institute for Safe Medication Practices.
ASCENSION HEALTH
Ascension Health, the nation's largest non-profit hospital system,
has numerous hospitals nation-wide which have implemented patient
safety programs unique to their specific needs. Examples include:
Columbia-St. Mary's Hospital of Milwaukee, Wisconsin asked all
clinical staff to complete a survey on medical errors. Over 400
responses offered many narrative comments on areas where the hospital
excels in safety as well as areas in need of improvement. The survey
prompted increased organizational communication with all clinical staff
which is providing valuable information on how to improve the
hospital's culture of safety. One project resulting from the survey is
a leadership patient safety rounds pilot program to assess safety
throughout the hospital.
St. Vincent's Medical Center of Bridgeport, Connecticut conducts a
similar leadership rounds program to speak with front-line staff in a
non-punitive way to discover ``near misses'' and to rapidly initiate
changes to prevent recurrences.
Western Maryland Health System of Cumberland, Maryland has adopted
several new medication-related programs, which include a non-punitive
computerized medication event-reporting system, a computerized adverse
drug reaction surveillance system, a patient Warfarin education program
conducted by pharmacists, and computerized, patient-specific physician
alerts for ``black box'' and other FDA-related drug warnings.
St. Agnes Hospital of Baltimore, Maryland has established the
MICROMEDEX system on their Intranet which provides detailed monographs
on drugs, alternative medicines, toxicological management, reproductive
risks, and interactions, among others. This system is used extensively
by medical and pharmacy staff to reduce medication errors. In addition,
St. Agnes invested $1 million in state-of-the-art patient beds which
have alarms to prevent patients from falling, allow patients to sit up
in bed to avoid bed sores, and allow patients to be weighed in bed by
built-in scales.
BAXTER INTERNATIONAL, INC.
The AUTROS Point of Care System, developed by Baxter, is the first
automated medication management system that combines medication bar-
coding and wireless technology to link physicians, pharmacy and nursing
at the point of care. This solution set integrates drug delivery
products with the information required to ensure safe and effective
delivery of medication. The clinical decision supports and accompanying
alerts and warnings of the system is delivered through a wireless
network, which supplies data in a way that improves clinician workflow,
as it supports the clinicians as they deliver patient care under
increasing time and cost pressures.
This integrated patient management solution provides instantaneous
decision support at the bedside to ensure the five rights of patient
safety: the right patient, the right medication, the right dose, the
right time, and the right route; together, these facilitate the right
outcome.
BD
BD (Becton, Dickinson and Company) is well known for its health
care worker safety initiatives designed to reduce the incidence of
sharps injuries. In addition to these initiatives, BD takes a systems
approach to two key and highly interrelated processes that directly
impact patient safety: the pre-analytical laboratory specimen process
and the medication administration process.
Accurate Lab Specimens: The majority of erroneous laboratory
results--which can lead to the prescribing and administration of
inappropriate and perhaps harmful treatments--are caused by mis-
identification of specimens at the point of collection. BD helps
eliminate these errors by providing an affordable and comprehensive
system that includes process analysis and redesign, root cause error
analysis, a unique line of bar coded specimen containers, hand-held and
bar code enabled computer technology, and management reports that allow
hospitals to track and measure the results achieved with the system.
These components have demonstrated specimen error reduction by an
average of 79 percent, and have improved safety through the reduction
of medication, transfusion, and other errors.
Bedside Identification: The last opportunity to halt medication
errors is at the point of administration, or the patient's bedside.
Designed to halt medication errors at the point of administration, the
BD Rx System uses hand-held and bar code enabled computer technology to
identify the system user, the patient, and the drug prior to
administration. This ensures compliance with the clinician's order and
safe medical practice.
CLEVELAND CLINIC FOUNDATION
The Cleveland Clinic's widely acclaimed ``POEMs'' (Prevention of
Errors in Medicine) Initiative is based on the premise that each
specialty and practice group understands error-prone links in its own
clinical work better than any administrative body. The Cleveland
Clinic's POEMs task force has had each component within the Clinic
contemplate medical errors encountered in that specialty's duties, or
``near misses'' experienced or heard about in its specialty. As part of
this process, each department chairman was directed to discuss the
issue and the project at all staff meetings and to encourage the
solicitation of specific activities and procedures that represent
potential error-prone processes germane to that department or
specialty.
Each department determined and ranked its top 2-3 specific error-
prone processes. An internal departmental working group then developed
appropriate interventions and strategies to mitigate potential errors.
FRANCISCAN MISSIONARIES OF OUR LADY HEALTH SYSTEM, INC.
A group of hospitalists at Our Lady of the Lake Regional Medical
Center in Baton Rouge, Louisiana, led by Dr. Richard Slataper, has
developed a tracking and reporting tool to promote evidence-based
treatment. This is a hybrid system of paper and computer technology. It
uses a customized data collection program from Pendragon Forms written
for hand-held computers. This tool has already been successful in
improving the use of ACE inhibitor therapy in patients with chronic
heart failure. Current plans are to expand to other areas such as
coronary artery disease, stroke, diabetes, hypertension, vaccinations,
code status and living wills, pain assessment, restraint use, smoking
cessation, and deep venous thrombosis prophylaxis.
MERCK & COMPANY, INC.
Merck has undertaken several initiatives to reduce medication
errors in both the inpatient and outpatient settings. Examples include:
Inpatient: Merck has introduced color-coded unit dose blisters to
aid clinicians in distinguishing different doses of the same medication
and to minimize dispensing errors. Merck also has voluntarily placed
National Drug Code bar codes on virtually all hospital unit-of-use
products to aid hospitals choosing to use drug identification
technologies.
Outpatient: Because patient under- or over-dosing is an important
source of medication errors, Merck has developed innovative packaging
for some products that includes a simple calendar that can be
personalized to help patients remember when they should take their next
dose. The special pack also contains a user-friendly patient leaflet
(in addition to the more technical leaflet for pharmacists and doctors)
to help inform patients about their medicine and their condition to
improve compliance with treatment.
PREMIER, INC.
Premier's Clinical Performance Initiatives (CPI) seek to improve
the quality and safety of health care and reduce costs at its more than
1,800-member nonprofit hospitals. This is done through the use of
evidence-based best practices that are implemented for widespread use.
Each year-long collaborative effort between the CPI staff and
representatives from Premier hospitals includes: face-to-face meetings
and conference calls with CPI project directors, medical experts, and
statistical analysts who guide Premier hospitals through clinical
improvement processes; site visits by Premier's CPI staff to learn the
specific needs of hospitals; networking among hospitals to overcome
barriers and share successes; and analysis of data submitted by each
hospital to Premier's Perspective <SUP>TM</SUP> database, a national
warehouse of clinical data. Premier experts analyze this data to help
hospitals identify ways to improve health services while reducing
costs.
VHA INC.
VHA offers its member hospitals Patient Safety Team Training, a
product focused on improving patient safety, patient satisfaction, and
performance in the emergency or labor delivery departments. VHA's
Patient Safety Team Training uses proven methods based on aviation crew
resource management techniques employed in that industry. Grounded in
two decades of research and development, this training process was
evaluated at 12 leading health care organizations over two years.
Effectiveness results included fewer observed clinical errors,
minimized litigation costs, and enhanced ability to achieve compliance
with patient safety standards of the Joint Commission for Accreditation
of Healthcare Organizations as well as with the IOM's 1999 patient
safety recommendations.
Under this program, a VHA physician and nurse who have expertise in
team training implementation in the high-performance, high-stress care
environment first conduct an on-site assessment of an organization's
readiness. They then conduct ``train the trainer'' sessions where
select physicians and nurses in the organization learn to present the
core curriculum to all staff members, bring about a culture change in
their department, and reinforce team work behaviors using facilitated
leadership and coaching.
Mr. Bilirakis. Thank you very much, Mr. Freeman.
Dr. Dennis S. O'Leary is President of the Joint Commission
on Accreditation of Healthcare Organizations, and he, too, will
show a video after his remarks.
Dr. O'Leary, please proceed.
STATEMENT OF DENNIS S. O'LEARY
Mr. O'Leary. Thank you. The Joint Commission very much
appreciates the opportunity to testify today on the important
contributions of the private sector toward improving patient
safety in health care organizations.
The Joint Commission is the Nation's predominant health
care standards setting and accrediting body. Founded in 1951,
the Joint Commission accredits almost 18,000 organizations
across the mainstream of the health care delivery system. The
scope of its activities and its focus on the safety and quality
of health care services has long placed the Joint Commission in
a unique position both to set and leverage expectations for
patient safety across the full spectrum of provider services.
In 1995, patient safety issues assumed an even more
prominent role in the Joint Commission's priorities. Having
just introduced a new standards framework that emphasized
attention to risk points in delivering health care services, we
were faced with an apparent outbreak of unanticipated injuries
and deaths in a variety of settings, including some of the
Nation's most prestigious hospitals.
These sentinel events became a clarion call to the Joint
Commission and to others that more needed to be done to improve
the safety of health care in this country. To this end, the
Joint Commission committed itself to a major national
leadership role in helping health care organizations understand
how and why health care errors occur, and in providing guidance
and direction in efforts to reduce health care errors and
adverse events.
First, we launched the Sentinel Event Program to encourage
the identification, reporting, and analysis of adverse events
inside health care organizations. Organizations were also asked
to report these events and the results of their analyses to the
Joint Commission's Sentinel Event data base.
We discovered that most serious adverse events were not
being made known, even to organization leaders, principally
because health care professionals involved in such occurrences
are deeply shamed and, at the same time, deeply fearful of the
humiliation and punishment that all too often has been the knee
jerk response to human error.
Joint Commission standards now require organizations to
develop internal processes that facilitate the identification
and thorough evaluation of adverse events and to take actions
to reduce or eliminate the possibility of such events in the
future.
Second, we have made a major investment in the development
and refinement of the tools necessary for in depth analyses of
these events. This has lent great credence to our iron clad
requirement that a root cause analysis be performed following
each sentinel event. Development of the root cause analysis
template for sentinel events is one of the most important
contributions that the Joint Commission has made to the patient
safety movement.
Third, the Joint Commission has introduced engineering
principles into its standards requirements to promote the
identification, analysis, and redesign of vulnerable
organization systems. Vulnerable systems increase the risk that
inevitable human errors will actually affect patients. The new
requirement for the conduct of failure mode and effects
analyses should create learning and preventive opportunities
without the actual experience of adverse events.
Fourth, the Joint Commission has worked aggressively to
share lessons learned with accredited organizations. By early
1998, the Sentinel Event data base had accumulated sufficient
data to identify significant groupings of sentinel events and
their underlying causes. With this information in hand, the
Joint Commission launched ``Sentinel Event Alert'' as a brief
periodical bulletin that would focus upon specific types of
sentinel events, describe lessons learned from the root cause
analyses of that group of sentinel events, and suggest measures
that health care organizations could take to avoid the
occurrence of such events in their own settings.
To date, the Joint Commission has issued 25 ``Sentinel
Event Alerts'' to its accredited organizations that address
such topics as patient suicide, infant abductions, wrong-site
surgery, transfusion reactions, and patient falls, amongst
others.
We have several new initiatives on the horizon. This coming
summer the Joint Commission will begin to focus the attention
of accredited organizations on a series of national patient
safety goals. Beginning next January, organizations will be
expected to be in compliance with specific high priority
recommendations associated with these goals.
Finally, the Joint Commission will convene a national
invitational conference on the business case for patient
safety. This conference is being co-funded with the Agency for
Healthcare Research and Quality. The purpose of this initiative
is to convince health care organization leaders that financial
investments in patient safety will indeed serve the bottom line
priorities that necessarily drive many of these organizations.
The road to patient safety is a never ending journey. This
is because the continuing evolution of this Nation's health
care capabilities make achievement of our patient safety goals
a moving target, but it is also because long standing change
will require counterintuitive strategies, culture change, and
radical alterations in the way health care professionals are
trained.
The patient safety challenges are neither small in number
nor small in magnitude, but progress is being made by the
private sector, by the public sector, and importantly, by both
working together. We should take great heart in this progress
as we continue our journey.
I would now like to conclude these remarks with the
presentation of one of the public service announcements we have
developed to encourage patients to also become involved in
reducing medical errors. Thank you.
[The prepared statement of Dennis S. O'Leary follows:]
Prepared Statement of Dennis S. O'Leary, President, The Joint
Commission on Accreditation of Healthcare Organizations
I am Dr. Dennis O'Leary, President of the Joint Commission on
Accreditation of Healthcare Organizations. Our organization very much
appreciates the opportunity to testify today on the important
contributions of the private sector towards improving patient safety in
health care organizations.
For those of you who are not familiar with the Joint Commission, we
are the nation's predominant health care standard-setting and
accrediting body. Founded in 1951, the Joint Commission is a not-for-
profit, private sector entity that is dedicated to improving the safety
and quality of care provided to the public. Its participating member
organizations include the American College of Surgeons; the American
Medical Association; the American Hospital Association; the American
College of Physicians-American Society of Internal Medicine; and the
American Dental Association. In addition to representation from these
organizations, the 28-member Board of Commissioners provides seats for
the field of nursing, and for public members whose expertise covers
such diverse areas as medical ethics, public policy, and health
insurance.
The Joint Commission accredits approximately 18,000 health care
organizations. In addition to accrediting the substantial majority of
hospitals in this country, the Joint Commission's accreditation
programs evaluate the quality of care provided by home care agencies;
ambulatory care centers and offices whose services range from primary
care to outpatient surgery; behavioral health care programs; nursing
homes; hospices; assisted living residencies; clinical laboratories;
and managed care entities. The Joint Commission is also active
internationally and, in fact, has provided leadership in promoting
attention to patient safety in other countries.
The scope and nature of the Joint Commission's involvement in the
health care delivery system places it in a unique position to both set
expectations for patient safety across the entire spectrum of provider
services and to measure adherence to those expectations.
history of the joint commission's involvement with error reduction
During the late 1980s, the Joint Commission initiated a complete
re-engineering of the accreditation process. The new standards
framework that was finally introduced in 1994 focused on identified
``risk points'' in health care delivery processes and substantially
strengthened the Joint Commission's emphasis on patient safety.
In 1995, patient safety assumed an even more prominent role among
the Joint Commission's priorities. The intensified focus on the
occurrences of serious adverse events in health care organizations--
which we call ``sentinel events''--grew out of an apparent ``outbreak''
of widely publicized, unanticipated serious injuries and deaths in a
variety of settings, including some of the nation's most highly-
regarded hospitals. While not necessarily unique, as later studies
would show, these sentinel events became a clarion call to the Joint
Commission and to others that more needed to be done to improve the
safety and quality of health care in this country.
We understood early on the critical importance of learning more
about the epidemiology of these serious events, including the types of
occurrences, their incidence, and their underlying causes. Only through
amassing such information could we develop the capacity to share
knowledge with and provide guidance to health care organizations,
towards the objective of reducing future health care errors and
sentinel events. Such information would also prove to be essential to
future refinements of the Joint Commission's standards. The Joint
Commission, therefore, committed itself to a major national leadership
role in facilitating the identification of health care errors and
adverse events; in working with individual organizations to reduce the
risk of future adverse occurrences; and in sharing ``lessons learned''
with all accredited organizations. To these ends, the Joint Commission
launched its Sentinel Event Program in 1996.
The Joint Commission's experience with its Sentinel Event Program
provides us the unique perspectives we wish to share with you today.
Our odyssey has been both an enlightening and sobering experience. The
risk of errors in health care is high--an inevitable correlate of the
intense human effort involved in patient care; the complexity of the
services provided; the expectations as a matter of public policy, that
care be provided with fewer resources; and the progressive introduction
of new procedures, new technologies, and powerful new drugs, each with
their potential great benefits and their potential for leading to
patient harm. But we are dealing with more than the complexity and
humanity of patient care. Most health care errors and even serious
adverse events are not made known to organization leaders. This is
principally because health care professionals involved in such
occurrences are deeply shamed and, at the same time deeply fearful of
the humiliation and punishment that all too often has been the knee-
jerk response to human error by organization leaders as well as by
professional licensure boards and state and federal quality oversight
bodies.
In truth, if responsibilities are to be assigned, they have lain,
and continue to lie, with organization leaders in assuring that safety
is prospectively (and today retrospectively) built into all vulnerable
organization systems and processes that have the potential to impact
patient care. Humans, including health care professionals, will always
make errors. The goal, we now understand, is to prevent those errors
from reaching or affecting the patient. And the continuing challenge
for all of us is to leverage and incent health care organizations and
health care professionals to invest in these preventive efforts.
The Joint Commission's odyssey has involved the gathering of
information, the sharing of knowledge, and the setting and application
of state-of-the-art standards. However, as reflected in the Joint
Commission's Sentinel Event Database <SUP>1</SUP>, we are far closer to
the beginning of the journey than we are to the end.
---------------------------------------------------------------------------
\1\ The Joint Commission's Sentinel Event Database contains
information on nineteen types of serious adverse events in ten
different settings. The database has been used to inform the
development of recommended practices and available to other
organizations who are working on patient safety initiatives.
---------------------------------------------------------------------------
the joint commission's approach to error-reduction
From the outset of its intensified focus on patient safety in 1995,
the Joint Commission has required the performance of an in-depth
analysis (``root cause analysis'') of underlying causes for any
sentinel event made known to the Joint Commission either through self-
reporting (currently 80% of known occurrences) or through other sources
such as the media (currently 20%.) The Joint Commission defines a
reportable sentinel event as an unanticipated death or permanent loss
of function. The definition also encompasses certain other serious
occurrences such as transfusion reactions, infant abductions, and
patient rape, among others. Joint Commission standards now require
organizations to adopt a definition of sentinel event that is at least
as encompassing as that of the Joint Commission, to establish internal
processes for reporting sentinel events, to conduct root cause analyses
of all such occurrences, and to make appropriate changes in
organization systems based on the root cause analysis findings.
Current policy also encourages the voluntary reporting of sentinel
events and the associated root cause analysis results to the Joint
Commission's Sentinel Event Database. The root cause analysis is in
essence a retrospective evaluation of what went wrong. Almost all of
these analyses identify multiple contributory factors (``latencies''),
which can be addressed through systems improvement. The value in
gathering and sharing this information lies in the reality that these
are in fact rare events with which most organizations have had little
or no first hand experience. The preventative efforts that they are
able to undertake based on this information have the potential to
reduce the overall frequency of future sentinel events.
Development of the root cause analysis template by the Joint
Commission is probably one of the most important contributions that it
has made to patient safety. This tool has been made available to the
field through numerous publications that provide step-by-step
descriptions for completing these analyses. The Joint Commission places
such a premium on the effective conduct of these analyses that failure
to perform a satisfactory root cause analysis after a known sentinel
event places the organization at risk for loss of its accreditation.
While root cause analyses play a vital role in efforts to reduce
health care errors and adverse events, they are by definition reactive
in nature. For this reason, the Joint Commission--in collaboration with
widely-recognized patient safety experts--has now developed and
recently implemented additional patient safety standards that place the
onus on organization leaders to ``create a culture of patient safety.''
The standards delineate expectations for the organization's patient
safety program that draw particular attention to the needs for teamwork
and effective communications among responsible care-givers. These
latter priorities are based both upon the well-known experiences of the
aviation industry and upon findings from the Sentinel Event Database
which identify communication breakdowns as the most common underlying
factor across all types of sentinel events.
These standards also create new requirements for the prospective
analysis and where appropriate, re-design of systems identified as
having the potential to contribute to the occurrence of a sentinel
event. These ``failure mode and effects analyses'' (FMEA) are expected
to create learning and preventive opportunities without the actual
experience of an adverse event. Because there are today multiple
vulnerable systems in health care organizations, each organization is
expected to set FMEA priorities based either upon its own risk
management experience or upon external sources such as the Joint
Commission's Sentinel Event Database.
The new patient safety standards finally create the expectation
that unanticipated outcomes will be communicated to patients and/or
their families. Here again, the Joint Commission has taken a leadership
role in addressing the public's patient safety interests.
By early 1998, the Sentinel Event Database had accumulated
sufficient data to identify significant groupings of sentinel events
and their underlying causes. With this information in hand, the Joint
Commission launched Sentinel Event Alert as a brief periodic bulletin
that would focus upon specific types of sentinel events, describe
lessons learned from the root cause analyses of that group of sentinel
events, and suggest measures that health care organizations could take
to avoid the occurrence of such events in their own settings.
The first Sentinel Event Alert issue dealt with the then common
practice of storing concentrated potassium chloride on nursing units.
This liquid concentrate is used in the preparation of intravenous
solutions but is deadly when administered in an undiluted form. The
Alert suggested that concentrated potassium chloride not be available
outside the pharmacy unless specific safeguards were in place. By all
reports, this Alert and the attention placed on it by Joint Commission
surveyors has been instrumental in virtually eliminating deaths due to
the unintended administration of concentrated potassium chloride to
patients. Since 1998, the Joint Commission has issued 25 Sentinel Event
Alerts to its accredited organizations. These Alerts include over 50
evidence or expert-based recommendations for preventing adverse events
of various types. The topics addressed cover a wide range of issues--
inpatient suicide, infant abductions, wrong site surgery, transfusion
reactions, and patient falls, to name a few.
During an onsite survey, Joint Commission surveyors typically
assess the organization's familiarity with and use of Sentinel Event
Alert information. Each accredited organization is expected to consider
for its own adoption information in the Sentinel Event Alerts that is
relevant to its services. This coming summer, the Joint Commission will
focus attention of accredited organizations on a series of National
Patient Safety Goals. Beginning in January 2003, organizations will be
expected to be in compliance with specific recommendations associated
with these Goals that have previously been published in Sentinel Event
Alerts or show that they are using alternative approaches that are just
as effective. The National Patient Safety Goals will be recommended to
the Joint Commission's Board of Commissioners by an expert panel that
was appointed earlier this year.
Last month the Joint Commission, with the active support of the
Centers for Medicare and Medicaid Services, launched its consumer-
oriented Speak Up campaign. This program seeks to actively engage
patients as members of the health care team and as active participants
in their own care by ``speaking up.'' The key messages of the Speak Up
campaign, which are delineated in greater detail in its eye-catching
brochure, include the following:
<bullet> Speak up if you have questions or concerns.
<bullet> Pay attention to the care you are receiving. Make sure you are
receiving the right treatment. Don't assume anything.
<bullet> Educate yourself about your diagnosis and the medical tests
you are undergoing and your treatment plan.
<bullet> Ask a trusted family member or friend to be your advocate if
you can not advocate for yourself.
<bullet> Know what medications you take and why you take them.
<bullet> Use a hospital, clinic, surgery center or other type of health
care organization that has undergone rigorous on-site
evaluation.
<bullet> Participate in all decisions about your treatment.
This campaign acknowledges that physicians, health care executives,
nurses and other health care workers are working hard to address the
problem of health care errors. This campaign reinforces their efforts.
The Joint Commission has already provided thousands of brochures and
Speak Up buttons to accredited organizations. The brochures, now
available in English and Spanish, are tailored to specific types of
organizations such as hospitals or nursing homes, and contain a blank
panel that allows the individual organization to add its own patient
safety message to the brochure. The response to the campaign has thus
far been very positive. Other groups--such as pharmaceutical companies,
business coalitions, advocacy groups, and church groups--are also now
expressing interest in using the brochures with their employees/
constituents.
The next Joint Commission patient safety initiative, also of recent
vintage is the core component of a Patient Safety Taxonomy. It is no
small irony that the progressively expanding national discussions on
patient safety over the past several years are not based on a common
language. For example, there are no agreed upon definitions of medical
error or adverse event. This critical missing element has hindered our
collective ability to collect patient safety data in a consistent
fashion, analyze of process failures, mine data (e.g., trends, pattern
analysis), and disseminate new knowledge about patient safety.
The Joint Commission has now created the framework of a
comprehensive Patient Safety Taxonomy and is working with the Agency
for Healthcare Research and Quality and others to finalized a
communication tool that will have broad potential utility for
consumers, provider organizations, health care practitioners,
purchasers, researchers and other audiences. The framework of the
Taxonomy has recently been shared with the Institute of Medicine for
consideration by its newly established committee on patient safety data
standards.
Finally, as the creator (in 1996) of the highly regarded Annenberg
Conferences on patient safety, the Joint Commission will branch-out
over the next nine months to serve as the convener of four diverse
national conferences on topics whose common underlying theme is patient
safety. The most significant of these--an invitational conference on
the Business Case for Patient Safety that is being co-funded through
the Agency for Healthcare Research and Quality--will seek to convince
health care organization leaders that financial investments in patient
safety will indeed serve the bottom-line priorities that necessarily
drive many of these organizations. Following the identification of a
persuasive business case, the conference will frame a research agenda
that has the potential to support a future business case for safety.
The remaining three conferences will bring together both recognized
experts and disparate interests to address the issues of Nurse
Staffing, Emergency Preparedness, and Emergency Unit Overcrowding. The
confluence of factual information across these three sets of issues
already suggests that a progressively under-girded delivery system is
unable to either meet public expectations nor the provision of state-
of-the-art or to assure the public of the safety of the care that is
delivered to those able to access service. Significant public policy
recommendations are expected to emerge from each of these conferences.
In still other collaborative efforts, the Joint Commission is
working with the Centers for Medicare and Medicaid Services, the Agency
for Healthcare Research and Quality, the National Quality Forum,
purchaser-led Leapfrog Group, and others to further these patient
safety initiatives.
the challenges ahead
The road to patient safety is a never-ending journey this is
because the continuing rapid evolution of this nation's health care
capabilities make achievement of our patient safety goals a moving
target. But it is also because long-standing change will require
counter-intuitive strategies, culture change, and radical alterations
in the way health care professionals are trained.
<bullet> Counter-intuitive strategies must meet the need to protect and
support caregivers who make errors rather than punish them.
When caregivers feel safe, patients are more likely to be safe
because such strategies create the opportunities to truly learn
from identified errors.
<bullet> If we cannot change the blame and punishment culture of our
society, we must incent and promote counter-cultures of safety
in our nation's health care organizations. This is a non-
delegatable responsibility of organization leaders; those
having the courage to rise to this challenge should be
rewarded.
<bullet> This country has trained generation after generation of
outstanding individual clinicians--physicians, nurses, and
other professionals who make important, even life-and-death
decisions for and with patients every day. Now we need to
expand the applied knowledge base of future generations to
include systems thinking and analysis, and we need to train
this new advance guard of health care professionals as
interdisciplinary teams.
The patient safety challenges are neither small in number nor small
in magnitude. But progress is being made by the private sector, by the
public sector, and importantly, by both working together. We should
take great heart in this progress as we continue our journey.
Mr. Bilirakis. Okay, go ahead. Please proceed, Dr. O'Leary.
Video Narrator. Hospitals: One place patients hope nothing
will go wrong, but sometimes things do go wrong with
potentially life threatening consequences. Reported cases of
wrong-site surgery are on the rise, according to an alert just
issued by the Joint Commission on Accreditation of Healthcare
Organizations.
The problems include surgery performed on the wrong body
part or site, the wrong patient, or even the wrong surgical
procedure altogether.
Mr. O'Leary. These cases leave patients and their families
incredulous and undermine their confidence in doctors and
hospitals. They should never happen, but unfortunately, they
still do. That is why we are enlisting patients and their
families to help eliminate these tragic mistakes.
Video Narrator. Patient Mark Deedan who had knee surgery
made himself part of the health care team, learning all he
could about the procedure before being wheeled into the
operating room.
Mr. Deedan. I was the one being operated on, and I felt it
was my responsibility to make sure that things went well in the
operating room and to become part of the health care team.
Video Narrator. Here are some tips for patients to prevent
wrong-site surgery. Ask to have the surgical site marked with a
permanent marker to avoid any confusion. Make sure there is
total agreement between you and your surgeon about exactly what
will be done and where. Finally, don't be intimidated. Bring in
a list of any and all questions to the surgeon before the
procedure.
Video Voice. The team, consisting of the surgeon, the
anesthesiologist and the nursing staff, must work together and,
if there is an issue and there is some concern about a process,
they need to stop and regroup so that we understand what the
optimal thing to do is for the patient.
Video Narrator. The warning about surgical mistakes is the
latest alert issued by the Joint Commission, a group dedicated
to making patient safety the top priority among accredited
health care organizations. This is Sarah Vedor reporting.
Mr. Bilirakis. Thank you, Doctor. Does that complete your
presentation?
Mr. O'Leary. It does. Thank you.
Mr. Bilirakis. Thank you very much, sir.
Dr. Roger L. Williams is with U.S. Pharmacopeia. Dr.
Williams also has a demonstration after his oral statement.
Please proceed, sir.
STATEMENT OF ROGER L. WILLIAMS
Mr. Williams. Thank you, Mr. Chairman. It is an honor to be
here speaking on this important topic. I will speak briefly
about the United States Pharmacopeia, and then about our
innovative programs to promote patient safety, after which Ms.
Diane Cousins who presented before this subcommittee
approximately 1\1/2\ years ago, will give a demonstration of
one of our reporting programs termed MedMARx.
USP was begun in 1820 and, as such, is only slightly
younger than the U.S. Congress. Physicians published the first
pharmacopeia in the United States in 1820 as a means of listing
the best medicines, giving them useful names, and providing
standard recipes for their preparation. Even then,
practitioners wanted their patients to receive carefully
prepared medicines and use them correctly.
Over the years, Congress has relied on USP on many
occasions. In 1848, Congress passed the Drug Import Act which
requires drugs entering the United States to conform to USP
standards. In 1906, in the Pure Food and Drug Act Congress
recognized USP standards for manufactured drugs.
In 1938, Congress stated that FDA can legally enforce USP
standards, including its packaging and labeling requirements.
This policy represented an early attempt by Congress itself to
address patient safety. Deaths at the time were occurring in
the United States, because bichloride of mercury tablets, which
is a highly poisonous disinfectant, were being confused with
mercurous chloride tables, a therapeutic product. I am sure the
committee can see how easy that confusion would occur.
In the last 30 years, USP has been in the forefront of
innovative efforts to promote patient safety. This focus arose
because of USP's historic concern with the quality of
therapeutic products. In 1971 USP created a quality defect
reporting program, and in 1991 USP moved to medication errors,
based on the understanding that medication errors are multi-
disciplinary and multi-factorial, not just related to product
defects.
From this early experience, USP developed a new program for
medication errors, termed MedMARx. MedMARx is innovative in
many ways. First, it uses a standard terminology and
classification for medical errors, thus facilitating reporting.
Second, MedMARx captures extensive information beyond just the
facts of the errors. It looks at factors within a hospital
system that contributes to the error. Third, MedMARx allows
anonymous reporting. Finally, MedMARx embraces the latest in
information technology by receiving reports into USP's national
data base electronically over the Internet.
The success of MedMARx has been impressive. Over 500 of the
Nation's hospitals currently utilize MedMARx. In 1999, there
were 6,000 reports to the data base. The next year there were
40,000 reports. Last year, there were over 100,000 reports, and
this year we are expecting 200,000 reports from practitioners
all across the country to the USP data base. That will total
approximately 400,000 error reports to our data base.
MedMARx has already provided highly useful information. We
have learned that, obviously, the practitioners are willing to
report errors if a useful reporting tool is available and if
reporting is protected from disclosure. Hospitals in the
program for more than 1 year also report more frequently.
We have learned that the vast majority of errors do not, in
fact, cause patient harm. Only a small fraction, 5 percent, of
total reports are associated with patient harm, and this
finding corresponds with other industries. In the aviation
industry, it is well known that most errors do not result in
plane crashes. This information is critical to understanding
how to implement system improvements.
We have learned that certain drugs are especially error
prone, insulin, anticoagulants, and the opiates, which is not
surprising considering their narrow dose range. And we have
gathered important information about medications in children
and the elderly, because MedMARx captures both gender and age
information.
Here we have learned some specific things, and here are two
examples. Deaths have been reported due to inadvertent mix-up
of neuromuscular blocking agents which paralyze the respiratory
system and are highly useful in anesthesiology. USP, by its
standards setting activities, responded with proposed warnings
and color differentiation on packaging and labeling of these
products.
Another example: Deaths have been reported due to the
direct injection of an anti-cancer drug, Vincristine sulfate,
into the spine instead of into the vein. It is highly toxic
when given into the spine. USP responded again with changes in
packaging and product labeling requirements that have reduced
the error.
USP is excited about MedMARx, and we have many plans for
the future. It can be expanded to other points of care. It can
include adverse events and medical errors. The data base
enhances research efforts to determine best practices for
reducing errors, and it supports USP standard setting
activities that approve packaging and labeling of therapeutic
products.
We are interested in setting standards for computer based
physician order entry systems and other support tools for
practitioners, and USP wants to work collaboratively with all
stakeholders in this effort.
As the Institute of Medicine recommended in its landmark
1999 report, Congress can strengthen MedMARx and other
reporting programs by enacting a Federal medical error
reporting privilege approach. For example, USP has worked
closely with Congresswoman Morella in preparing a bill she
first introduced last Congress and which she introduced
yesterday to provide a privilege for information reported to
USP. We believe that such legal protection would enhance
reporting even beyond the assurance of anonymity.
In closing, I would like to make the following reports. A
national data base for error reporting is highly desirable. USP
is building that data base and will work collaboratively with
Congress and all other stakeholders in its use.
Standard nomenclature and report formats, coupled with
cutting edge information technology approaches, promote error
reporting at points of care. The national error reporting data
base should be extended to all points of care and all types of
health care errors.
Thank you for the opportunity, and I will now turn the
presentation over to Ms. Cousins who will demonstrate MedMARx.
[The prepared statement of Roger L. Williams follows:]
Prepared Statement of Roger L. Williams, Executive Vice-President and
Chief Executive Officer, United States Pharmacopeia
On behalf of the United States Pharmacopeia (USP), I appreciate the
opportunity to testify before the Health Subcommittee of the House
Energy and Commerce Committee regarding innovative strategies to
improve patient safety.
In recent years, USP has been in the forefront of innovative
efforts to promote patient safety. Patient safety depends on the
availability of methods and procedures to understand patient risk at
the point of care. USP's primary effort in this regard has been to
develop reporting programs that capture medication error risk and lead
to the implementation of systems to prevent errors.
USP's patient safety efforts have culminated in the development of
MedMARx <SUP>SM</SUP>, an interactive, anonymous, Internet-based
medication error reporting program. MedMARx compiles medication error
reports from participating hospitals in order to analyze patient safety
trends, develop best practices and disseminate this information to
participating hospitals. Approximately ten percent of the nation's
hospitals participate in the program.
In the three full years since its inception, MedMARx has captured
over 200,000 reports of errors from participating institutions. USP has
already issued an annual report based on 1999 data and is preparing
another report for the year 2000 data. Our annual reports are provided
to Congress and other stakeholders, and data from the MedMARx program
can be shared in anonymous form with relevant Federal and State
agencies.
MedMARx is based on the premise that patient safety can more
effectively be enhanced in a culture that emphasizes systemic change
rather than blame. Early results support this view. We are encouraged,
for example, by a marked increase in the number of second year reports
from hospitals that participated in the first and second consecutive
years of MedMARx availability.
The core innovation of MedMARx lies not just in a software program,
but more broadly through engagement of frontline practitioners who, at
the end of the day, are critical to any effort to promote patient
safety. Whatever success MedMARx achieves rests on these practitioners
and their commitment to good patient care.
Based on its experience, USP strongly supports congressional
efforts to reduce preventable mistakes that occur throughout the
continuum of prescribing, dispensing, administration and use of
medicines. Specifically, USP supports enactment of a federal medical
error reporting privilege to enable health care providers to report
errors to systems like MedMARx without fear of adverse legal
consequences. USP further believes that federal policies should
encourage public and private initiatives at the national, state, and
local levels to enhance patient safety and reduce the medical mistakes
that cost the health care system billions of dollars each year.
i. background on usp
Founded in 1820, USP is a private not-for-profit organization whose
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. USP's governing bodies
include its Convention, which meets every five years, and a Board of
Trustees, which provides direction to staff in the years between
Convention meetings. Standards-setting activities are conducted by the
USP Council of Experts.
Membership in the Convention (representing approximately 400
associations), on the Board (11 members representing Convention
constituencies), and on the Council and its Expert Committees
(approximately 800 members) is entirely voluntary. To support the
activities of these bodies, USP maintains a paid staff of approximately
320 in its Rockville offices. USP derives its income from the sale of
its publications and reference standards materials. USP's expertise as
a standards-setting body has been recognized in numerous federal laws.
USP standards are published in the United States Pharmacopeia and
National Formulary (USP-NF). These standards are officially recognized
in the Food, Drug and Cosmetic Act and are enforceable by the Food and
Drug Administration. Thus, USP's primary publications are official
compendia of the United States. More recently, Congress named USP and
NF as the official compendia for dietary supplements.
Key components of USP's legal authority derive from efforts to
improve patient safety. For example, prior to 1938 only USP standards
for determining the identity, strength, quality, and purity of articles
used in medical practice were legally enforceable, but that year
Congress recognized and made legally enforceable USP packaging and
labeling requirements in response to numerous fatalities resulting from
the accidental ingestion of bichloride of mercury tablets. At that
time, compendial packaging and labeling standards for bichloride of
mercury tablets (a disinfectant), which was frequently and mistakenly
taken for mercurous chloride tablets (a cathartic), recommended the
following:
``[t]ablets of an angular shape having the word `poison' and
skull and crossbones design distinctly stamped upon it. The
tablets are to be colored blue. They are to be dispensed in
securely stoppered glass containers on the exterior of which is
placed a red label bearing the word `poison'.''
Even today, many of our monographs (e.g., potassium chloride for
injection concentrate) incorporate legally enforceable packaging and
labeling requirements for the purposes of reducing medication errors.
ii. usp reporting programs
In 1971, USP's historical concern with the quality of drug products
led it to collaborate with the FDA and the American Society of Health
System Pharmacists to create the Drug Product Problem Reporting
Program--a national program in which health professionals were asked to
voluntarily report problems experienced with drug products on the
market. These defects often related to inadequate packaging or labeling
such similarity in color or design of the label, or similar sounding
drug names.
USP's 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 as a practical matter, many of
USP's standards indirectly affect professional practice and many
practice standards are based on USP standards.
(a) Medication Errors Reporting Program
In 1991, USP began working with the Institute for Safe Medication
Practices to coordinate the Medication Errors Reporting (MER) Program.
Since then, the MER Program has received more than 7,000 reports of
actual and potential medication errors. 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, USP has come to understand that errors are
multi-disciplinary and multi-factorial. They can be committed by
experienced or inexperienced staff, by health professionals, support
personnel, students, and even patients and their care givers.
Medication errors can 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, or to the medication handling and delivery systems in which
the products are used and in which individuals operate and interact.
As each MER report is received, it is shared with the product
manufacturer and with the Food and Drug Administration. USP does not
require that the name of the reporter, patient identity, or facility be
reported. When such information is provided, however, USP respects the
confidentiality of the report and will purge the identity of the
institutions and individuals named in the report upon request.
Reporters are advised of any corrective actions resulting from their
report. Such actions are disseminated to all individuals who have
reported to the MER Program and are publicly available on the USP web
site.
In 1995, USP helped form the National Coordinating Council for
Medication Error Reporting and Prevention. The Council, for which USP
serves as secretariat, brings together 23 national organizations and
agencies to promote the reporting, understanding and prevention of
medication errors. The Council has developed a standardized definition
of medication error, a taxonomy for error reporting and a newly revised
index for categorizing medication error severity.
(b) MedMARx
Through USP's work with the MER Program and other collaborative
efforts, USP realized the need for national standardization of
medication error reporting, especially in hospitals. Hospitals were
eager to submit reports to USP in an anonymous and standardized format
that would allow them to compare their errors to those in other
participating facilities. USP set out to develop and refine such a
model for hospitals, and then broaden the model to include other health
care settings and other types of reporting such as adverse drug
reactions.
On July 27, 1998, USP made MedMARx 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). MedMARx is structured to support an
interdisciplinary systems approach to medication error reduction and
foster a non-punitive environment for reporting.
Hospitals use the program as part of the organization's internal
quality improvement process. Hospitals can review errors entered by
other institutions in ``real time'' and can also view any reported
action taken by other institutions in response to the error. 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 whether risk prevention measures
or training programs should be instituted or, if the error profile is
so serious, whether the decision to stock the drug should be rejected.
MedMARx also supports the performance improvement standards of the
Joint Commission on the Accreditation of Healthcare Organizations
(JCAHO), which requires institutions to learn from the experiences of
others in order to reduce risk.
Currently, over 500 hospitals have enrolled in the MedMARx program
and other hospitals and health systems are joining rapidly. Hospitals
of various types and sizes spanning fewer than 50 beds to approximately
1000 beds are enrolled. Participating hospitals include some operated
by the U.S. Departments of Veterans Affairs and Defense (which includes
hospitals around the world), as well as state-owned facilities.
Since 1998, more than 210,000 records have been submitted to the
MedMARx database. USP has issued a summary of MedMARx data collected in
1999. In that first calendar year, 6224 reports were submitted by 56
facilities. The 2000 data report will be released on May 20th. During
the second year of the program, participation strengthened to 184
hospitals submitting 41,296 reports.
The data show that the most common products involved in errors--
Insulin, Heparin, Warfarin, and Opiate analgesics--require careful
dosing, close monitoring, and adherence to protocol where established.
The most common types of errors are omission, wrong dose, and
unauthorized/wrong drug. With the aforementioned drugs, the outcome of
such errors could be serious to fatal.
Yet another key finding is that most errors do not reach the
patient--only 3% of errors reported to MedMARx caused patient harm. USP
continues to gather reports of ``near misses'' because, as the
experience with aviation has shown, all errors are critical to an
understanding of patient risk.
MedMARx is readily expandable to other points of care in addition
to hospitals and can collect information about medical errors beyond
medication errors--in fact, USP is moving in this direction at the time
of this report.
iii. post-reporting activities
Reporting is not a goal in itself. Rather, the purpose of reporting
systems is to analyze the information provided and to implement
effective, sustainable interventions that will prevent errors from
recurring. Ideally, these interventions will be replicated throughout
health care settings. Data received through USP reporting systems have
led to changes in individual hospitals, across health systems, and have
even led to changes in USP-NF packaging, labeling and nomenclature
standards for health care systems nationwide.
(a) Actions by Hospitals and Health Systems
By compiling and trending errors in a standardized way, USP's
reporting systems can lead to innovative strategies to address errors.
For example:
<bullet> Patient Misidentification--A health system identified a trend
of ``wrong patient'' errors and determined that nurses were not
verifying the patient's identification (i.e., checking the
patient's wrist band) before administering medications. A
thorough review of the cases found that wrist bands were often
coming off or being removed for various reasons. This finding
resulted in a reevaluation of all wrist band materials and
procedures that will likely impact the entire system. A program
is also being developed to encourage patients to ask questions
and be informed about the medication administration process.
<bullet> Prescription Writing Abbreviations--A health system noted an
unexpected increase in medication errors due to the use of
abbreviations in prescription writing. The health system was
puzzled since it had banned the use of error-prone
abbreviations in prescription writing procedures. A closer look
at MedMARx data revealed that the health system had acquired a
hospital in the region, but newly privileged physicians had not
been apprised of the no-abbreviations rule. Educational
programs were immediately implemented for physicians from the
newly-acquired hospital.
<bullet> Additions to a Hospital's Formulary--In considering whether to
add a new drug to its formulary, a hospital looked at the
accumulation of reports and actions taken by other institutions
as documented in MedMARx. The information was used in two ways:
(a) to determine if the errors were severe enough to deny the
drug's addition to this hospital's formulary; and, (b) to
determine what preventative measures could be incorporated in
this hospital's processes to allow adding the drug.
<bullet> Dispensing by Robotics--A hospital interested in purchasing a
robot to dispense medications reviewed its MedMARx data and
identified which dispensing errors might be prevented by the
robot. The reduction in health care costs realized by
preventing such errors justified the investment in new
technology.
<bullet> Medication Omissions--A notable trend of treatment omissions
for respiratory therapy led respiratory therapy directors from
hospitals across a health system to convene. The reasons for
the omissions were two-fold: (1) patients were not in their
rooms at treatment times because they were receiving therapy
elsewhere in the hospital; and, (2) patients were refusing
therapy. Two possible solutions are being tested. First, a new
method of scheduling treatments will bring various caregivers
to the patient's bedside in turnstile fashion so that
respiratory, occupational, and other therapies are
appropriately sequenced. Second, the hospitals are now actively
explaining to patients the need for each treatment.
(b) Actions by USP
Data collected through its reporting programs enable USP to
evaluate and implement drug product standards, and in some cases
practice standards and requirements, aimed at preventing errors. The
following examples describe some of the steps taken by USP in response
to medication error reports. The standards that have been developed as
a result of USP's error reporting programs have emerged from USP's
Council of Experts, which has a number of Expert Committees that
develop appropriate standards to reduce medication errors.
<bullet> Product and Nomenclature Standards--Deaths reportedly due to
the accidental misadministration of concentrated Potassium
Chloride Injection led to (1) changing the official USP name to
Potassium Chloride for Injection Concentrate to give more
prominence to the need to dilute the product prior to use; (2)
a requirement that labels bear a boxed warning that reads:
``Concentrate: Must be Diluted Before Use;'' and (3) a unique
requirement that the cap for this drug must be black in color
and must be bear an imprint in a contrasting color with the
words: ``Must be Diluted.''
<bullet> Product Standards and Practice Recommendations--Deaths
reportedly 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.
<bullet> Nomenclature Standard--Deaths reportedly due to the name
similarity of Amrinone (cardiotonic) and Amiodarone (cardiac
depressant) have led USP and the United States Adopted Names
(USAN) Council to change the official and nonproprietary name
of Amrinone to Inamrinone to distinguish the two.
<bullet> Product Standard--Deaths reportedly 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 of this therapeutic class of neuro-
muscular blocking agents. The standards would add warnings and
color differentiation to the labeling and packaging of the
products.
<bullet> Practice Recommendations--A study of MER and MedMARx data in
pediatric populations led to the development of recommendations
for error avoidance in this population. The recommendations are
aimed at all disciplines across all health care settings and
include packaging and labeling recommendations as well as
recommendations for compounding and dosing medications safely.
(c) USP leadership activities
Because MER and MedMARx are the only private-sector, national
medication error reporting systems, USP is uniquely situated to play a
leadership role in national and international efforts to improve
patient safety.
The USP commitment to medication error prevention is broader than
merely collecting data. USP has enrolled a number of MedMARx-
participating hospitals in a long-term project called ``Strategic
Research Partnerships'' to propose indicators of quality and best
practice standards for use of specific medications. The first project
involves Heparin, a drug revealed by both MER and MedMARx data to be
commonly involved in errors. These hospitals aim to create a standard
protocol for Heparin therapy, implement the protocol, and develop best
practices for prescribing, dispensing, administering and storing the
drug which will address the reasons for recurring errors.
Because of its long history in medication error reporting and
prevention, USP participates in many collaborative efforts at the
national and state levels to reduce health care errors. Thus USP is
involved in (ongoing activities are italicized):
<bullet> Veterans Administration Adverse Drug Event Working Group
Project
<bullet> Veterans Administration Work Group on Nomenclature and
Taxonomy for Creating a Medication Error Reporting System
<bullet> JCAHO Expert Panel on Medication Safety
<bullet> Pittsburgh Regional Healthcare Initiative, AHRQ Grant Advisor
on Improving Patient Safety: Health Systems Reporting,
Analysis, and Safety Improvement Research Demonstrations
<bullet> National Quality Forum Safe Practices Steering Committee, Vice
Chair of Technical Advisory Panel to the NQF Committee
<bullet> Health Research and Education Trust of the AHA, Commonwealth
Grant Advisor on Reducing Medication Errors, Pathways for
Medication Safety.
<bullet> University of North Carolina, AHRQ Grant for Centers for
Education and Research on Therapeutics--Reporting Adverse Drug
Events in Infants, Children, and Adolescents
<bullet> American Academy of Family Physicians, AHRQ Grant Advisor on
Developing Center for Education and Research on Patient Safety
in Primary Care
<bullet> University of Pennsylvania, AHRQ Grant Advisor on Developing
Innovative Approaches to Improving Patient Safety
<bullet> Maryland Patient Safety Coalition
iv. recommended congressional action
USP believes that its reporting systems have already contributed to
improvements in patient safety. But the full potential of USP's
reporting programs remains to be realized, and Congress can help
accelerate this progress. Specifically, USP urges Congress to create a
more conducive legal environment for reporting medical errors through
enactment of a federal medical error reporting privilege. Such a
privilege would strengthen reporting systems and thereby foster the
development of systems to prevent medical errors.
Many states have established peer review privilege statutes to
encourage self-evaluation in the interest of improving the quality of
healthcare. But the extent and application of state protections vary,
and state laws do not necessarily protect information that is reported
outside the hospital, for example to a national reporting system. In
some states, the privilege is explicitly waived if information is
provided to a third party. These policies discourage practitioners and
facilities from sharing medication error reports with USP and other
organizations.
In its landmark 1999 study ``To Err is Human,'' the Institute of
Medicine specifically endorsed establishment of a federal reporting
privilege. Since then, USP has urged Congress to implement the IOM
recommendation. For example, we have worked closely with Congresswoman
Morella in the development of legislation she introduced in the 106th
Congress (H.R. 3672) to establish a privilege for USP reporting
systems. We understand that just yesterday, Congresswoman Morella
reintroduced her bill with bipartisan cosponsorship. We urge serious
consideration of the Morella bill, and any similar legislation that
provides clear protection to practitioners and facilities that report
medical errors for the purposes of improving patient safety.
We have also worked in coalition with the American Medical
Association, the American Hospital Association, the American Nurses
Association, the Joint Commission on the Accreditation of Health Care
Organizations and other health care organizations to develop principles
for the development of patient safety legislation. In brief, our
principles call for the establishment of a federal privilege to
encourage reporting in a non-punitive environment that encourages a
culture of safety.
A federal privilege will encourage facilities and practitioners to
report medication errors to USP in a consistent and uniform manner,
thereby increasing the chances of identifying trends and implementing
effective corrective measures that will help improve the quality of
care for patients nationwide.
If strengthened in this manner, the USP reporting programs may lead
to creation of a national database of medication errors. Such a
database can be highly useful to Federal and State officials,
practitioners, patients and others as they seek to understand patient
risk and ways to reduce it. We contemplate a continually evolving
database that can be used in many different circumstances and to
different purposes. A great deal of work--and active participation from
many constituencies--is needed to achieve USP's goals in this area and
thereby improve health care in the United States and other countries as
well.
conclusion
USP looks forward to working with Congress and other stakeholders
in the ongoing effort to improve patient safety. We especially look
forward to working with Congress to strengthen legal protections that
will result in greater use of reporting systems, and thereby fuel the
development of system changes that will prevent errors before they
occur.
Mr. Bilirakis. Please proceed.
Ms. Cousins. Good morning, Mr. Chairman and members of the
subcommittee. Thank you for this opportunity to demonstrate
MedMARx.
MedMARx was developed based on USP's experiences and
collaborations. Hospitals look to USP as a trusted intermediary
with whom reports could be shared. Although this is a slide
presentation, MedMARx is actually an Internet accessible data
base.
When hospitals first access the system, the system randomly
assigns a specific facility ID which becomes the hospital's PIN
number of sorts in the system. Although USP knows what
hospitals are enrolled and knows what IDs are registered in the
system, USP has no way to match a hospital to a specific
facility ID, thereby maintaining anonymity.
When accessing MedMARx for the first time, hospitals create
a facility profile which captures characteristics such as bed
size, type of facility, staffing levels, and services offered.
MedMARx includes hospitals ranging in bed size from under 25 to
more than 800. Currently, over 500 hospitals participate,
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 error differently.
Some hospitals define error as a deviation from the
prescriber's order, thus presuming the order is correct. Other
hospitals only capture errors at the point of administration
and not in dispensing or prescribing.
The GAO report on adverse drug events noted that a broad
definition of error means that the total number of errors
reported will be inherently higher. Using the standardized
category index, hospitals classify errors based on the severity
of outcome to the patient. There are nine categories, including
potential errors, intercepted errors, and harmless errors that
reach the patient. The remaining categories reflect varying
degrees of harm, including fatality.
Prior to using MedMARx, hospitals have focused only on
harmful errors or only on errors that reach the patient, and
have given little attention to potential or intercepted errors.
The next four slides capture the fields for basic report
entry. MedMARx fields are an optimal mix of free text, together
with structure and coding. The volume of data captured in each
report is tiered so that more data is collected as the severity
of the outcome increases. MedMARx data show that the most
common types of errors are misdoses and wrong doses.
MedMARx captures causes of errors, contributing factors to
the error, and location where the error occurred. The data show
that the top cause of error is performance deficit, meaning
that health professionals were trained to know better, yet
erred nonetheless. Further analysis shows contributing factors
here are distractions and workload increase.
Because MedMARx was designed to have a systems approach to
medication error reduction, the program does not capture the
names of individuals involved in the error, but rather the
level of staff involved. These data help identify areas for
focused policy development and training.
These final fields in basic report entry capture the
learning that can be achieved by participating in a national
data base. Hospitals are not only able to see the errors
entered by other hospitals, but also able 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.
For your information, the patient's age but not date of
birth or other identifiers is captured as a risk factor and
will be useful in studying errors in pediatric and elderly
populations.
Various formats of output are available through the search
function, including spreadsheets, graphs, and data 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 the points in the medication use process
where the errors occurred and the severity of those errors. To
view the two records causing temporary harm, which are category
E in red, that were committed in the prescribing phase, they
would click to drill down on that area of the chart, and then
click on the hyperlink to access the specific record.
Presently, a hospital can view its own data or all data
submitted by other participants. This summer a complementary
program called a multi-facility module will allow a health
system to group the data for its hospitals as another subset.
The health system's involvement will drive a higher level of
participation by its hospitals, help identify error trends
across the system, and help to design, implement, and monitor
systemwide solutions to errors.
Thank you, Mr. Chairman, for this opportunity to
demonstrate MedMARx.
Mr. Bilirakis. Thank you. Dr. Williams, does that complete
your presentation?
Mr. Williams. Yes.
Mr. Bilirakis. Dr. Bonnie Westra is a PhD and an RN and
here representing the American Nurses Association. Please
proceed, Doctor.
STATEMENT OF BONNIE WESTRA
Ms. Westra. Good morning, Mr. Chairman and members of the
subcommittee. I am Bonnie Westra, a registered nurse and former
co-chair of the American Nurses Association's Committee on
Nursing Practice Information Infrastructure, which is a
committee of the Congress on Nursing Practice and Economics.
I thank you for the opportunity to address medical errors
and technology, important issues for every nurse. The ANA is
the only full service association representing the Nation's
registered nurses through its 54 constituent member
associations. Our members include RNs working and teaching in
every health care sector across the entire United States.
Nurses are the largest health care workforce in the Nation,
numbering more than 2.7 million nurses, from the nurse midwives
who attend delivery to geriatric nurse practitioners who manage
end-of-life care to staff nurses who care for us during times
of acute injury or illness. Nurses are integral to health care
across the human life span.
Nurses are always seeking to have better outcomes through
their management with health care professionals in hospitals,
clinics, community health centers, offices, nursing homes and
also patient homes. We are the ones who provide the majority of
direct patient care and who manage the technologies
incorporated into health care experiences.
Recent advances in medical technology have resulted in
truly amazing treatments and procedures. These advances are
extending and improving the quality of our lives. They also are
increasing the complexity of health care. Just think of
premature infants in neonatal units or the burn victims from
recent terrorist attacks. These patients are able to survive
and to thrive when only a few years ago they could not.
Nurses in the units manage patients who are supported by
complex technologies such as heart-lung bypass machines,
ventilators, and constant drug infusers. Patients such as these
require constant monitoring, as even minute changes can quickly
lead to disaster. Today's nurses are engaged in painstaking,
complicated care. They have fewer support systems than ever
before, and that significantly increases the potential for
error.
Numerous opportunities for failure exist at many points,
even in the simplest health care experiences. Nurses, in the
role of patient advocate, often intercede to prevent system
errors which may or may not result in patient harm. Appropriate
technology applications can assist nurses in order to be able
to prevent medical errors, but conversely, these same
technologies can compromise the health care delivery process
and even create more adverse outcomes.
Current health care information system resources can
prevent errors by removing unreadable, handwritten orders and
documentation. Errors can be significantly reduced if the
information systems include decision support capabilities such
as direct Internet access to journal articles and professional
references, prompts and alerts, drug-to-drug and drug-to-food
interaction alerts, and care pathways or protocols and clinical
guidelines. But such robust capabilities remain useless if, in
fact, nurses and other health care professionals don't have
immediate access to the technologies, must engage in difficult
or prolonged sign-on efforts, or have to make do with
documentation or order entry systems that fails to meet the
information needs.
Information systems and their software applications must be
designed with user input, incorporating standardized data and
processes, wherever possible. Nurses and other clinicians who
actually use the system are the best source to identify data
needed, how to match the way they think and work, and where to
remove redundant data entry. Use of standard data enables
abstraction of information from routine charting for quality
assessment initiatives aimed at identifying and preventing
medical errors.
Unless standardized data are built into routine charting,
data cemeteries will result when information cannot be
abstracted and systems can't talk to each other. The lack of
interface between systems results in lack of accessible
information to all of the patient's providers, potentially
contributing to increased health care costs and delays in
patient care.
New technologies need to be evaluated carefully. For
example, voice recognition technologies have been recommended
for the incorporation into health care practice settings to
reduce medical errors. This has considerable potential, but
also the potential for new medical errors emerge in the form of
incorrect conversion of the audio file to digital content.
On the other hand, barcode technology is a mainstay within
the business community and is now finally moving into the
health care mainstream as a method to reduce medical errors.
This technology can assist in ensuring the right patient
receives the right medication in the right dose via the right
route at the right time. However, delays in its use will
continue to occur unless a single set of barcode standards are
identified, acceptable hardware devices create reliable
results, and health care professionals review their business
processes to identify junctures and activities that can benefit
from safe and effective barcode use within the practice
settings.
Internet access and electronic mail, or e-mail, use
continues to explode in consumers and health care professionals
and the technologies in their daily lives. With these increases
in communication between clinician and patient or between
clinician and clinician, however, we can actually create
medical errors if we use informal communication processes,
rather than using built-in algorithms, decision rules and
documentation components of health care information systems
that could be incorporated.
Proper use of any technology involves correct preparation
of the user. This may involve formal education, but frequently
it is informal or nonexistent learning experiences. With
increasing budget constraints, such educational opportunities
are cut, and users are expected to intuitively discover how to
use technology. Trial and error may be fine when you are
learning at home, but it is unacceptable in a dynamic hustle
and bustle of a health care setting. Just in time learning is
too late in a patient care emergency, and increases the risk of
error.
Standards organizations, vendors, and health care
professionals are partnering to integrate communications,
documentation, and other standards into health care
environments to be able to help and reduce the impact of
medical errors. By establishing recognized language and data
standards, everyone can use the same terms with the same
definitions and meanings, and thereby prevent confusion and
error. Standard product, procedure, and process naming
conventions can then be programmed into information systems so
that software is able to permit the user to select the correct
items.
The recognized standards must accommodate all health care
professionals in their practice. For example, the current HIPAA
code sets at this time do not include complementary and
alternative therapies nor the diagnoses, interventions and
outcomes terms used by registered nurses in their diverse
practice settings.
These few examples reflect the complexity of medical errors
issues. Although medical technology is often most presented as
the preventive or curative strategy for medical errors, unless
nurses and other clinicians are involved in the design,
implementation and evaluation of technology solutions, medical
errors could actually increase. Quick fix technology fails to
address the systems and cultural changes necessary to maximize
patient safety and care.
Nurses strive to be partners within a nonpunitive system
that meets the needs of patients and reduces the patient risk.
Our nurses are providers who will ultimately implement the new
technologies and, therefore, need to play a substantial role in
the development, implementation, evaluation and redesign of
these systems. Their contribution is integral to the prevention
of medical errors.
Thank you very much.
[The prepared statement of Bonnie Westra follows:]
Prepared Statement of Bonnie Westra, on Behalf of the American Nurses
Association
Good morning, Mr. Chairman and Members of the Subcommittee. I am
Bonnie Westra, a registered nurse and former co-chair of the American
Nurses Association's Committee on Nursing Practice Information
Infrastructure, a committee of the Congress on Nursing Practice and
Economics. Thank you for the opportunity to address medical errors and
technology, important issues for every nurse. The American Nurses
Association is the only full-service association representing the
nation's registered nurses (RNs) through its 54 constituent member
associations. Our members include RNs working and teaching in every
health care sector across the entire United States.
Numbering more than 2.7 million, nurses are the largest health care
workforce in the nation. From the nurse midwives who attend delivery,
to geriatric nurse practitioners who manage end-of-life care, to staff
nurses who care for us during times of acute injury or illness, nurses
are integral to health care across the human lifespan. Nurses touch
patients and manage teams of healthcare professionals in hospitals,
clinics, community health centers, offices, nursing homes and patient's
homes, always seeking to have better outcomes. We are the ones who most
often care for patients and manage the technologies incorporated into
their healthcare experiences.
Recent advances in medical technology have resulted in truly
amazing treatments and procedures. These advances are extending and
improving the quality of our lives. They are also increasing the
complexity of health care. Just think of premature infants in neonatal
units or the burn victims from the recent terrorist attacks; these
patients are able to survive and thrive when only a few years ago they
could not. Nurses in these units manage patients who are supported by
heart-lung bypass machines, ventilators, and constant drug infusers.
Patients such as these require constant monitoring, as even minute
changes can quickly lead to disaster. Thus, today's nurses are engaged
in painstaking, complicated care, with fewer supports than ever before
and significantly increased potential for error.
error
Error is defined as the failure of a planned action to be completed
as intended (an error of execution) or the use of a wrong plan to
achieve an aim (an error in planning). (IOM, 2000) Numerous
opportunities for failure exist at many points in even the simplest
healthcare experience. Nurses, in the role of patient advocate, often
intercede to prevent system errors which may or may not result in
patient harm. Appropriate technology applications can assist the nurse
in these efforts to prevent medical errors. Conversely, those same
technologies can compromise the healthcare delivery process and create
even more adverse outcomes.
The identification, resolution, and prevention of medical errors
necessitates participation by every stakeholder, including registered
nurses who are at the bedside, in examining and then improving the
appropriate processes and systems. Such process improvement and re-
engineering initiatives demand appropriate ongoing data collection and
analysis strategies, implementation of standards and protocols to
effect change, and measurement of outcomes that demonstrate success or
failure in preventing the same or new types of error. Assessment of
human factors associated with the proposed technology need appropriate
attention. Computer-based information systems can assist in some of
those activities.
healthcare information systems
Current healthcare information system resources can prevent errors
by removing unreadable handwritten orders and documentation. Errors can
be significantly reduced if the information systems include decision-
support capabilities such as direct internet access to journal articles
and professional references, prompts and alerts, drug-drug or drug-food
interaction alerts, ``order set'' templates, and care pathways/
protocols and clinical guidelines. But such robust capabilities remain
useless if nurses or other healthcare professionals do not have
immediate access to the technologies, must engage in difficult and
prolonged sign-on efforts, or have to ``make do'' with a documentation
or order entry system that fails to meet their information needs.
Inadequate orientation and skills at making the system work optimally
further contribute to failures of the systems.
For example, personal digital assistant devices (PDAs) or other
larger handheld data entry units can aid in point of care data entry by
nurses. However, if the available software applications do not support
recording of standardized terms used to describe the assessments,
diagnoses, interventions, and outcomes, nurses can not describe the
patient, care activities and future plans. These elements are then lost
to other nurses and healthcare professionals as they assume
responsibility for patient care management. Similarly, lack of
communications technology standards may also prevent effective
information transmission to and from the PDA if network, software and
hardware incompatibilities exist. And what about the practical aspects
of the nurse having to carry yet another item in a pocket, in hand, or
on a belt or waistband? Can the device accommodate right or left hand
users? Are displays adequate for the viewer or must the nurse scroll
through numerous screens to find the necessary information or data
entry screen? Does the device remain charged long enough to allow
completion of the necessary documentation or information seeking
activities?
Information systems and their software applications provide
significant volumes of clinical and administrative data and
information. However, in order to assure that the data is most
meaningful and that it relates to the appropriateness of the patient's
care, nurses must be integral to the design and development of the
system. This ensures that information can be tapped for quality
assessment initiatives aimed at identifying and preventing medical
errors. The technology also provides the opportunity to reevaluate
systems and processes already in place, as a means to reducing
inefficiencies. Unfortunately, data cemeteries may be the more common
result when information systems are unable to ``talk'' to each other or
the reports can not be generated because documentation standards have
not been implemented. Duplication results when the information gathered
isn't accessible to all of the patient's providers, potentially
contributing to increased healthcare costs and delays in patient care.
These deficiencies are being targeted by HIPAA rules and various
standards initiatives such as HL7, ASTM, ANSI, and DICOM.
voice recognition
Voice recognition technologies have been recommended for
incorporation into healthcare practice settings to reduce medical
errors when clinicians refuse or cannot complete manual data entry
processes in an information system. Although errors caused by poorly
written orders and documents have been removed with voice recognition
systems, the potential for new medical errors emerges in the form of
incorrect conversion of the audio file into digital content.
When considering implementation of this technology to reduce
medical errors, nurses find such a strategy less useful because of the
concern for maintaining the confidentiality of patient information.
Nurses are highly mobile healthcare professionals who frequently
document assessments and caregiving information. They usually work in
noisy and populated work centers, patient's private homes, and busy
community clinics. Such locations do not support confidentiality of
patient information that may be dictated into an information system
microphone.
Currently specific ``machine'' training for voice recognition
systems must be completed for each individual user, not a small task
for the regular and float nursing staff assigned to a busy hospital
nursing unit or clinic. To further complicate any voice recognition
system implementation plans, the current practice for registered nurses
incorporates report activities that are completed at end of shift or at
time of transfer of patient care to another provider. Therefore, this
technological approach to medical error reduction and prevention could
prove cumbersome and may be difficult to implement for this group of
professionals.
barcode technology
Barcode technology is a mainstay within the business community and
is now finally moving into the healthcare mainstream as a method to
reduce medical errors. Potential uses include barcodes for supplies and
pharmacy products, as well as unique patient, staff, and location
identification labels. This technology can assist in ensuring the right
patient receives the right medication in the right dose via the right
route at the right time. Implementation delays will continue to occur
until a single set of barcode standards are identified, acceptable
hardware devices create reliable results, and healthcare professionals
review business processes to identify junctures and activities that can
benefit from safe and efficient barcode use within practice settings.
Provisions must be made for effective backup strategies that must
accommodate times of network or electrical power failures. For example,
packaging of unit dose medications needs standardization of barcode
labeling, an initiative being addressed by device vendors,
pharmaceutical and pharmacy representatives, and must include
consumers, nurses and other healthcare professionals. Education and
Training
Proper use of any technology involves correct preparation of the
user. This may involve formal, or most frequently, informal or non-
existent learning experiences. With increasing budget constraints, such
educational opportunities are cut and users are expected to intuitively
discover how to use the technology. Trial and error may be fine when
learning how to use a computer, computer application, cell phone, PDA,
or some other device or procedure in the privacy of the home, but is
unacceptable in the dynamic hustle and bustle of a healthcare setting.
Just in time learning is too late in a patient care emergency and
increases the risk of error.
Instruction manuals may not have been purchased, may not be current
for the newest software application, or disappear if attached to the
device. The paper or on-line manuals may not be understandable to the
user as many frustrated cell phone users can attest. Human factors
considerations may not have been incorporated in the learning
materials.
Healthcare professionals are obligated to maintain their skills,
knowledge, and competence to provide quality care without errors.
Academic preparation for entry into practice and continuing education
professional experiences need to provide opportunities for acquisition
and refinement of computer and information management skills,
understanding of new processes and technologies, and the appreciation
of prevention of medical errors and development of quality assessment
and implementation programs. Addition of such curriculum content
involves faculty preparation and funding for supporting technologies.
role of standards
Standards organizations, vendors, and healthcare professionals are
partnering to integrate communications, documentation, and other
standards into the healthcare environment to help prevent errors or
reduce the impact of medical errors. By establishing recognized
language and data standards, everyone can use the same terms with the
same definitions and meanings and thereby prevent confusion and error.
Standard product, procedure, and process naming conventions can then be
programmed into information system software programs to permit the user
to select the correct item.
The recognized standards must accommodate all healthcare
professionals in their practice. For example, recognized HIPAA code
sets do not yet include complementary and alternative therapies, nor
the diagnoses, interventions and outcomes terms used by registered
nurses in their diverse practice settings. Incorporation of
standardized language of practice will permit appropriate data
collection and reporting, improved information management strategies,
and knowledge generation activities. This supports incorporation of
appropriate protocols and practice guidelines into practice to prevent
errors and track outcomes and variances that may need to be identified
as medical errors. The secondary review of clinical documentation about
diagnosis, interventions and outcomes will finally permit more accurate
accounting of actual or potential medical errors, whether an error in
the planning or an error in the execution of the plan.
unique patient identifier
Although not yet available and not considered a technology by some,
the unique patient identifier is significant for nurses patients to
prevent errors in the practice environment. Nurses care for patients
across every setting and need to share extensive amounts of information
about these individuals, groups, and populations with colleagues and
other health professionals. Continuity of care between home health,
hospital, long term care or hospice settings is a mandate. Reliance on
name or hospital number does not help the nurse in confirming the
correct patient information is being accessed or displayed when the
individual uses the name Mary Smith today but was identified as
Kathleen Mary Jones a month ago before her final divorce decree.
electronic mail and internet access
Internet access and electronic mail (e-mail) use associated with
healthcare delivery continues to explode as consumers and healthcare
professionals include these technologies in their daily lives.
Consumers are using the billions of electronic worldwide web pages for
information about health promotion, disease characteristics, and
treatment options. Healthcare professionals respond to resultant
consumer questions about care options and decisions and may use select
available Web educational materials as quality patient education
resources.
Increasing reliance on e-mail communications, between clinician and
patient or between clinician and clinician, opens new avenues for
medical error prevention or generation, depending on the viewpoint. For
example, patients can raise their questions before taking a dietary
supplement or vitamin that may interact with a prescribed medication or
treatment. Similarly, patients may alert the clinician of an
observation or response that could become a significant problem if
allowed to continue.
However, on the negative side, use of electronic mail can create
medical errors because this somewhat informal communication mechanism
does not incorporate the checks and balances provided in the carefully
tested, built in algorithms or rules-based order entry and
documentation components of healthcare information systems. Similarly,
medical errors may result when confidentiality and security measures,
like public-key and encryption technologies, are not in place to
prevent tampering or public disclosure. A unique patient identifier
becomes even more important in this environment where e-mail addresses
may be shared by multiple users and e-mail content should be linked to
the appropriate patient's clinical record.
Potential medical error opportunities exist in the arena of web-
based personal health records. Internet services may broker patient
health information stored on the website which may include marketing of
inappropriate products to the individual that may result in medical
errors. Potentials for incorrect reporting of laboratory or other
results exist that then become parts of the individual's personal
health record. Medical errors may occur if clinicians consider these
results to be valid and reliable measurements and use them to make
decisions about a patient's care.
culture and context
Incorporation of technology solutions into practice requires active
integration by the healthcare professional in each work setting. The
past practice has been to purchase the technology and then expect
nurses and other healthcare professionals to welcome the new tools,
gadgets, or processes. However, imposition of these solutions may not
yield the preferred outcomes and may even result in the creation of
medical errors. Careful evaluation of the setting before and after the
implementation to validate the appropriateness of the technology
solution and resultant outcomes occurs infrequently. This evaluation
process, rarely done, must include examination of the impact of change
on the organization's culture and patient outcomes within the
healthcare system.
conclusion
These few examples reflect the complexity of the medical errors
issue. Although technology is most often presented as the preventive or
curative strategy for medical errors, nurses find that not to be the
case in most instances and view it as ``technology looking for an
application.'' ``Quick fix'' technology fails to address the systems
and cultural changes necessary to maximize patient safety and care.
Nurses strive to be partners within a non-punitive system that meets
the needs of patients and reduces patient risk. They are the providers
who will ultimately implement these new technologies and therefore need
to play a substantial role in the development, implementation,
evaluation and redesign of these systems. Their contribution is
integral to prevention of medical errors.
Reference
Committee on Quality of Health Care in America, Institute of
Medicine. (2000). To err is human: Building a safer health system.
Washington, DC: National Academy Press.
Mr. Bilirakis. Thank you, Doctor. As a follow-up to your
comments, Dr. Westra, do any of the State licensing boards for
nurses require skills training in technology as part of their
licensing renewal process?
Ms. Westra. I would like to probably follow up with that on
some written testimony. My experience in working with schools
of nursing is I am not sure that it is required as part of
licensure. However, curriculum development has moved heavily as
of 10 years ago to start incorporating computerization as part
of the basis for nursing practice. But I will ask ANA to follow
up with some written testimony on licensure.
Mr. Bilirakis. Great. We would appreciate that.
Dr. O'Leary, have you found that accredited organizations
are complying with your patient safety standards, and maybe you
can share with us what might be the most challenging of your
expectations in that regard.
Mr. O'Leary. Well, I think our early experience--the newest
of the patient safety standards were introduced last July. So
we have a modest base of experience, but the early indications
are good.
I think the really great challenge here lies in achieving a
culture of safety inside organizations, and just a couple of
comments about that. It is really necessary that this be led by
the chief executive officer of the organization. It is not
really a delegatable function, and people in the organization
are not going to believe that it is safe to report medical
errors and adverse events unless it really is safe, and unless
the organization takes action when something happens.
That is going to be a slower process. One of the things
that our new standards do require is the introduction of new
engineering principles called Failure Mode and Effects
Analysis. That is a new concept inside health care
organizations, but maybe progressively we will see some of
these hospitals hiring engineers. it would be a great stride
for us.
Mr. Bilirakis. What sort of attitude are you getting from
them in response to all that?
Mr. O'Leary. I'm sorry, I can't hear you.
Mr. Bilirakis. What attitude do you see among these
hospitals and other health facilities?
Mr. O'Leary. Well, I think that patient safety is high on
their screen. I think the reality that everyone is facing that
resources are very limited; there are hospitals that worry
about making payroll on Monday. They need to be persuaded that
investing in patient safety is good for their future,
individually good for the CEO, a career enhancing decision, and
I think some believe that and some don't.
Our hospitals are strapped. I would come back to an earlier
remark here. You know, I know that Mr. Scully has commissioned
a recent study that showed that hospitals have adequate
operating margins, but that is a steady state circumstance in
which our patients remain at very high risk.
We are understaffed, not just for nurses but across the
board. One of the things that always gets cut when money is
tight is adequate training and orientation of staff, and all of
this is happening in the face of the introduction of new and
more complex drugs, procedures, technologies.
This is a little frightening, and I think we do have a
challenge in figuring out how we are going to infuse more
funding into the infrastructure of our hospitals and assure
that that money goes to the right places to buttress patient
safety activities.
Mr. Bilirakis. Dr. O'Leary, we have had three technologies
shared with us here today, and there are others out there. How
does a hospital select the one that they feel would be best for
them? Is it a matter of cost? Is it perhaps tied into the way
the hospital currently functions? How do they make that
decision?
Mr. O'Leary. Well, I think we get down to very simple
things like size, financial stability, and applicability of the
technology to the organization. Quite frankly, I think that we
almost need to use kind of a camel's nose approach by looking
at technologies that are relatively less expensive and more
likely to yield results in order to, one, produce savings for
organizations and, two, show them that these investments are
worthwhile so that we work our way to things like computerized
physician order entry, which many of us believe very
passionately will work as long as there is adequate training
and appropriate safeguards built into that technology. But you
see, many organizations don't have those resources, and they
are making difficult choices about what they select.
One way to make these things happen, of course, is to
require it by law or regulation, but we do that with some
hazard, because a lot of these rules and regulations do not
follow the one-size-fits-all rule. We have to be careful.
Mr. Bilirakis. Well, thank you. My time is about to expire.
So I am going to yield to Ms. Capps. Are you replacing Mr.
Brown? All right, Mr. Green.
Mr. Green. In fact, I'll ask a question that Ms. Capps
would probably want to ask. Ms. Westra, you mentioned in your
testimony that sometimes nurses are presented with new
technologies, and some we have seen today, expected to figure
out how to do it without formal training.
Now it is one thing if I buy a home computer and try to put
it in myself, but as you mentioned, nurses are working in an
environment where they can't afford to learn to operate a new
device by trial and error. Could you elaborate on the
importance of a facility's commitment to provide accurate
training when implementing these new technologies?
Ms. Westra. It is my experience that basic training is
provided with new technology. If you look at the development of
nursing curriculum or any other curriculum, there are stepping
stones to learning, and it is one thing to name something and
to define it. It is another to actually be able to trouble
shoot with it.
Oftentimes, for instance, the industry I work in is
community based practice or home care. Nurses are left
floundering out in the home care with new technology, and when
things fail, you know, understanding how the complexities of it
works, that is the level of education oftentimes that does not
occur.
I think basics are there, and I think that we need to
really take a look at, with the tight financial environments in
health care, how do we actually support agencies, not because
they don't care but that they really need to figure out how to
financially provide more education at a higher level of
education and not just entry level education with technology.
Mr. Green. Mr. Chairman, with that I would like to yield
the remainder of my time to Ms. Capps before we end up having
to leave to go vote.
Mr. Bilirakis. Ms. Capps is recognized.
Ms. Capps. I appreciate my colleague yielding, and I also
would follow up with Dr. Westra.
From my perspective, I guess maybe a bias as a nurse, we
heard wonderful progress in technology along this panel, and I
support and applaud all of it. This is what our ingenuity in
this country does best, and responding to the studies of errors
is sobering and people have responded to it. But the rubber
hits the road at the place where the patient and the health
practitioner interact with each other, whether it is in a home
setting, whether it is in the emergency room, whether it is in
critical care units.
I am going to zero in on nurse shortage, 125,000 positions
open today for RNs, the bulk of the people who do actually put
into practice the industry and our own desires to rectify
errors. So I am going to ask Dr. Westra about education and
training of nurses and how we can do this better, and also if
you would comment--it is kind of a two-pronged one--tell us how
we could improve the level of training, and give nurses the
feeling of competence and the skills so that they can be
competent and also the downside of when this is not in place.
What is it like to be floundering in the setting that you
described?
Ms. Westra. Well, it is my experience that coming out of
school today nurses have a fairly broad background in terms of
being able to practice. The specialty within health care is
overwhelming.
I used to work at Mayo Clinic. I worked in the emergency
room. For a year I did what we call float nursing. I was not
prepared to be specialized in orthopedic nursing, to be
specialized in all of the technology and the critical care area
where I would float to frequently.
People would do their best to help you understand, you
know, what was going on, but the number of new technologies
continuously coming through--you know, one IV pump is different
than the next IV pump when you are working with it. So I think
basic education really helps prepare for basic nursing to be
able to graduate, but it really doesn't provide the experience
level that you need on an ongoing basis.
I am concerned in the nurse shortage not only about
recruitment of people into the profession and being able to
support people to get through nursing education. I am also
concerned about retention. In Minnesota we had a strike last
year which was devastating in the Twin Cities area, and one of
the biggest issues that occurred as part of that strike was the
mandatory overtime.
Try to work, you know, 10, 12, 16 hours in an ICU with
complex technology, patients crashing around you, and the very,
very, very difficult medication management that you are doing
when you are tired. It doesn't work well, and then have it be
mandatory. This does not bode well for retention of nurses. So
we need to be able to retain nurses as well as recruit new
nurses into the practice.
Ms. Capps. And mandatory overtime is not something that
hospitals like to impose. They tell me that they are doing it
because there is a shortage.
Ms. Westra. They are desperate.
Ms. Capps. They are desperate, and if I could just follow
up with the average age of a nurse today is somewhere in the
mid-40's. It is a workforce that is aging. You talk about
nurses coming out of school today, those who come out and are
equipped. We also have the challenges of continuing and the
opportunity for a career ladder so that specialty training can
be made available with these more complex techniques that would
provide the kind of beside care and kind of care that we want.
I know I have used--I'm taking my time now, Mr. Chairman. I
won't ask for anymore.
Mr. Bilirakis. We can't even go into your time as yet,
because we have a vote.
Ms. Capps. We have a vote. I understand.
Mr. Bilirakis. Why don't we just go ahead and cut it at
this point, Mr. Green's time having expired, and then when we
return, if somebody is back on this side, we will go here. If
not, we will go right over here.
Ms. Capps. Thank you very much.
Mr. Bilirakis. Thank you. Will you please excuse us for--
I'm not really sure how long. I think we may have two votes. We
will be back as soon as we can.
[Brief recess.]
Mr. Bilirakis. The chairman will now yield to the
gentleman, Mr. Brown.
Mr. Brown. Thank you, Mr. Chairman, and I apologize on
behalf of the committee also and the way you sometimes
unfortunately get treated here. As the chairman said, those of
you that have never been here wonder about this place, and
those of you that have been here before also wonder about this
place, but are used to wondering about this place.
I have a couple of questions for Mr. Hethcox. The products
you have shown today are impressive in their potential to
reduce errors. I would think, and be almost certain, that many
hospitals, other facilities, would be eager to take advantage
of the products that you and others have offered.
I have heard, though, that some hospitals are reluctant to
implement new technology, because there is a lack of uniform
standards in the health care information technology field. Tell
us about that, if you would.
Mr. Hethcox. My assumption from your comment would be that
what they are referring to is when you go into most health
systems, you find that there have been varying philosophies
around the information infrastructure, whether it is a
completely integrated one, vendor system supporting all the
clinical departments as well as the patient information systems
or a philosophy that says basically we are going to select the
best of breed, so we are going to buy a laboratory system. We
will buy a general ledger system. We will buy a materials
management system, a pharmacy system, etcetera, and get best of
breed.
What you typically have, at least in that latter situation,
is a lot of great functionality that is oriented toward the
specific functionality of what that department does, like the
pharmacy department or a bedside charting system for nursing or
the materials management system, but health care really is a
team sport. When you look at it, everybody needs to be able to
play together, and too frequently we've got information systems
that are, in fact, fragmented to where they might work very
nicely for some subset of the institution but not well across
the board for all the disciplines that need to access data
that's critical.
In patient safety, for example, being a pharmacist one of
the things that we are real concerned about is what about lab
values? Well, if our pharmacy system doesn't have the
capability of communicating with the laboratory system so that
we get real time reports on abnormal lab values, we could
easily be dispensing medications that, frankly, are
contraindicated for that patient without being aware of it.
So I think you are starting to see, as you have heard a
little this morning already, institutions trying to find ways
to link the communications. In some cases it is better; in some
cases, it is worse.
Through Pyxis, because we do have to take information feeds
from a number of those systems that are sometimes disparate, we
have developed a great interfacing capability and, frankly, are
working today with most all the information infrastructure
systems that are out there, but it is through an interface
process and, frankly, a lot of the technologies that are in the
marketplace today do not have that expertise for interface
resident within their company structure. That presents a unique
set of challenges.
Mr. Brown. You mentioned health care is a team sport
nowadays. Talk, if you would, of the connection between a
hospital's decision to use your technology and its commitment
to devoting to human resources needed to manage it in terms of
when Cardinal might come in and selling a product and training.
Run through that briefly, if you would.
Mr. Hethcox. Well, let me use Pyxis maybe as an example to
put a real life case before us, since that is the technology we
talked about this morning. Let me back up to a point of saying
that, with our Pyxis products, we employ a group of folks that
are referred to as professional associates. These are nurses
and pharmacists that have come out of the practice world after
a number of years having used the Pyxis equipment.
They really become the counselors and the resource to help
the customer, the institution, really, if you would, size and
develop their implementation plans for the equipment that is
being brought in. So part of what we do is provide user type
expertise to help in identifying what should be structured, how
it should be implemented, and to work with the hospital staff
in doing the training.
The additional thing that we have recognized within the
Pyxis offerings is the number of folks, especially in the
nursing side of things, that we touch with the equipment and
the imperative that each nurse understands how to use that
equipment effectively. We have changed our training mode from
one where we used to have people literally leave the work site
to go to San Diego for a ``train-the-trainer'' process. They in
turn had to come back to the hospital, train other trainers,
and it just kind of filtered down, very complex, time consuming
process that is just really incompatible with today's
marketplace with the nursing shortage, etcetera.
So we have literally gone to Web based training, and the
nurses are left, in many cases, doing a lot of the training on
the patient care area without ever having to leave their
patient station. It becomes more of a flexible process
incorporated into the work environment, but one that is built
around competency standards, check-offs as they do their self-
study to validate that they, in fact, did comprehend how to use
the equipment, etcetera.
So we feel that we have tried to bring a very effective
tool to the marketplace with that training.
Mr. Brown. Thank you, Doctor. One more question, if I
could. Dr. Williams, you talked about medical errors and
reporting systems and strengthening reporting systems. That,
obviously--you are collecting the data, doing a better job of a
systematic reporting system, so it's just sort of a systematic
reporting, doesn't automatically translate into useful
information.
Run through, if you would, the process that USP uses to
turn reports on errors into information a hospital can use,
beginning from the time the error is committed and reported
until the hospital implements it.
Mr. Williams. Okay. Well, it is an excellent question.
First of all, Ms. Cousin has talked about how MedMARx itself
has a whole bunch of capability to issue reports that a
hospital can use internally. Hospitals can also work with other
hospitals and with USP in the main data base analysis.
Now USP, in addition, creates annual reports of the data
base for each year. We have prepared one already for 1999,
which we can certainly make available to the committee. We are
finishing the one for 2000, which again we can make available
to the committee, and we will try to create one for each year
annually that not only talks about the year itself but prior
years as well.
Then finally, I think USP wants to work very vigorously
with partners and stakeholders in the hospitals to issue action
items, alerts, specific reports, and also support for the
research efforts.
Mr. Brown. Dr. O'Leary, the root cause analysis that the
Joint Commission has encouraged hospitals and other facilities
to use is, I think, a pretty valuable tool. The Commission,
however, I think, has a valuable role, a role beyond education,
beyond sort of promoting--both encouraging and promoting
education.
Tell us more about your role in accrediting hospitals,
managed care organizations, other facilities, in light of
ensuring that these facilities do better in terms of
implementing, after gathering the data and analyzing mistakes,
to better prevent those mistakes. Run through that, if you
would.
Mr. O'Leary. Well, actually, the framework that we adopted
in the early 1990's was just really a continuous quality
improvement framework. It really requires an organization to
select key areas to measure, analyze data, and make systems
changes based upon the data, and then remeasure to show that
they achieved improvements.
We have new standards going into place in July, for
instance, which will require the use of measures that are
sensitive to nurse staffing and to staffing of other health
care professionals, with the expectation that when those
measures show that there is a problem, that we will require an
effective analysis and identification of the underlying problem
and appropriate action, whether that is the need for more
nurses, more commonly more training of nurses, or what have
you.
Our Sentinel Event data base, for instance, found that in
24 percent of the instances across all of these events, there
is a staffing numbers related problem. In more than twice those
instances, there are problems related to the training and
orientation of nurses for the kind of tasks that they are
supposed to be doing.
This coming July we will also establish a series of
national patient safety goals and specific recommendations
associated with those goals. This is a new venture, because for
the first time, above and beyond the broader standards
framework that is accreditation, we will be requiring our
organizations to comply with what, in essence, are clinical
practice guidelines. So we are getting down to the nitty gritty
level in terms of expectations.
So what, in essence, started as an educational vehicle, the
Sentinel Event Alerts, has come to the point of urging and now
requiring that certain things happen. I think that you can look
for that effort to expand over time.
Mr. Brown. Dr. Westra, would you want to either comment on
that or on sort of--My question to Mr. Hethcox, the first
question I asked, in terms of training when the systems are
brought into a hospital and the training is done jointly with
the hospital and Cardinal or the hospital and other providers,
other vendors, if you will, sort of the nurses' role in that.
Are you satisfied with the way hospitals are bringing nurses
into the training and dealing with these systems after the data
is gathered?
Ms. Westra. The majority of health care facilities do have
education departments or designated staff who are responsible
for education with nurses. As I mentioned earlier, I think we
are seeing initial education about equipment when it comes into
play. I think a lot of the trouble shooting is where the
challenges are. So we need to take a look at having incremental
learning modules, I believe, where it is initially how do you
use it, but then how do we develop expertise across staff in
terms of the trouble shooting that happens.
One of the things that I think is real important is that,
as we take a look at health care and where health care is
delivered, we have been tightening the belt on the inpatient
side so that more and more health care is being delivered in
community based settings and long term care facilities.
You have a lot less support out in those facilities for
dollars for education and staff available for doing trouble
shooting and education. I think with the aging population, it
is critical that we take a look at the preparation for people
to practice in those settings and to be able to do much more
advanced types of trouble shooting, because technology is
really--I mean, it has gone down to a level of practice that I
can't believe.
When I worked in a hospital, you know, using IV pumps was
something that took specialized training. Now we just send
people home with them and tell family to take care of them, as
well as a much more complex level of training. So we need to
take a look at how we not only train our staff but how our
staff are prepared to train our patients, because they are the
ones that are managing a lot of the technology when we are not
in the inpatient setting.
Mr. Brown. Thank you. Thank you, Mr. Chairman.
Mr. Bilirakis. I would like to finish up unless others come
in. I referred to the Institute of Medicine's 1999 report where
they estimated that between 44,000 and 98,000 Americans die
each year as a direct result of potentially preventable
mistakes.
Now that is quite a gap. So when we use the word estimate,
that is quite an estimation. So I don't know what the proper
figure is. But Dr. Ganske earlier in his opening statement
referred to the lack of proper definition, and each hospital is
on its own in defining that sort of thing.
A general question in that connection: In your estimation
are we finding more preventable type of hospital errors these
days than used to be the case? Maybe when I say used to be the
case, maybe we go back to prior to technology. We've got all
this technology we have heard about here today, and yet we are
talking about almost as many as 98,000, 100,000 deaths
attributable to medical errors. Any comments on that, brief
comments, if you would, please. Dr. O'Leary.
Mr. O'Leary. I don't think anyone knows what the real
baseline is. Even the figures you site were based upon medical
record reviews that were probably close to 10 years old by the
time they were published. Some people would say those are
probably underestimated, because they were based on things that
were written in medical records, and what about the things that
were not, and they only talked about hospitals, after all, and
there are a lot of other settings.
I would think, though, that if you looked at how we are
doing on the things that were reflected in that study, that we
have probably done a lot in terms of reducing those errors. But
health care changes radically every day. We've got the new
drugs, the new procedures, the new technologies. We are
introducing new benefits and new risks every day, and there are
major challenges in training people in even identifying what
those risks are and building safety into the systems that
support the care. That is really the challenge for the future.
What we do have is the attention of care providers now, and
we need to capitalize on that opportunity.
Mr. Bilirakis. More so than we have had that attention in
the past?
Mr. O'Leary. That is true.
Mr. Bilirakis. Dr. Westra, do you agree?
Ms. Westra. I do, and just one last plug, if I may. That
is, as we take a look at technologies, one of the most critical
technologies that we have is the information that we try to use
to communicate effectively. As one of the speakers mentioned
earlier, the more we can get to standardization of data so that
we can interface data across systems, I think the better off we
are.
There is a tremendous effort underway right now, including
HL7, SNOMED, the HIPAA legislation, a tremendous volume of
standardized data organizations working to take a look at how
we can build information technology. I think, if there is
anything that comes out of this hearing, the more we can
support standardization of processes and information so that,
in fact, we can communicate effectively, I think the better off
that we will be, and the contribution of this committee could
make would be tremendous.
Mr. Bilirakis. Okay. That really leads me into the last
question. I was asked by a member of the press as I was
hustling to make the vote did I anticipate that we would have
legislation as a result of this hearing, as a result of the
problem in general.
I said, that is the reason you hold a hearing. Legislation
is not always the answer in and by itself. But none of you, I
don't think, and I have asked Cheryl to remind me, have
mentioned that additional legislation is required. Should there
be maybe some legislation on our part to maybe standardize the
definition? Should there be legislation? How can Congress help?
I know, additional dollars for additional manpower, nurses,
etcetera, but I mean aside from that, which we are familiar
with those problems. There's no doubt about it. Yes, sir? Go
ahead, Mr. Freeman.
Mr. Freeman. Mr. Chairperson, our belief, certainly from
our perspective, would be that it is always important for us to
be partners and working with each other between the government
and industry. Our belief also in this perspective is that, as I
think you heard this morning, many of us in the health care
industry are working on our own to address the significant
challenges that exist in health care.
Our belief in general would be that we can, and will,
address these issues moving forward. It does take significant
leadership among those of us in the health care industry and,
quite frankly, our industry is behind what has been done in
other industries historically, particularly high tech
manufacturing.
The biggest challenge we face, I believe, includes in part
technology innovation, but even more importantly, behavioral
change in health care. So much of health care today still
thinks that, if we get it right 95 percent of the time, that's
okay. But since every occurrence of a defect is a human life,
think about a 95 percent correct rate. That's 95 percent. It
was great in high school. It's not great today in health care.
That means you have got 50,000 parts per million or
individuals out of every 1 million that are inadequately being
served. So striving for perfection is an attitude adjustment
that we in health care are starting to make.
You heard it from various members of our panel here this
morning, and we believe the best way to make that happen is for
us to take the lead as opposed to encountering perhaps
multitudes of additional regulations, in fact, that will drive
us in perhaps unproductive ways to change health are.
Mr. Bilirakis. Good point. Dr. O'Leary, very briefly, if
you could, please, sir.
Mr. O'Leary. First of all, I don't think we need
legislation for a new language or taxonomy. We have an
initiative to do that. It is being broadly shared.
Mr. Bilirakis. Can that become standard or uniform?
Mr. O'Leary. We can standardize the language, and we need
to do that, I think, for a variety of important reasons. The
legislation, I think, that we do need is protection against the
discovery or release of these adverse events and the underlying
causes.
We have a data base. It is the best and the richest of the
data bases on the stuff. We've got less than half a percent of
the real cases out there. If we are going to learn from these
events, we have to have access to the information, and there is
a huge show over that, and I think that is a role that Congress
could play.
Mr. Bilirakis. Okay. Dr. Williams.
Mr. Williams. Well, I think we would echo that, too. We
certainly support the privileged aspects of the bills that are
under consideration, and speaking as a standard setting body, I
am delighted to hear the chorus of calls for good standards,
which I could only agree will help reporting and help prevent
these errors.
Mr. Bilirakis. Thank you, Doctor. The Chair now yields to
Ms. Capps, and I would like to announce that one of the reasons
she has returned, in addition to asking you some questions, is
because we are going to hold that meeting on the nursing bill
right after this hearing is over. Go ahead, Lois.
Ms. Capps. Thank you very much, Mr. Chairman, and I will be
brief. I will sound, I suppose, like a one-note Charlie, but it
was acknowledged by more than one person on the panel that the
backbone of health care is the nursing profession. The delivery
system is done in large part by nurses across this country. So
errors are very much of concern to all of us who have the
initials R.N. after our names.
I focused my initial questions to Dr. Westra, and maybe,
Dr. Williams, you could help clarify for me, because you have
collected so much data. From your data on medication errors,
could you talk even just briefly about any way that staff
shortages or numbers of nurses or that kind of issue plays a
role in this?
Mr. Williams. Yes, Congresswoman. It's a very good point.
One of the things MedMARx does is it captures contributing
factors, and where contributing factors were noted, about 40
percent of the time people talked about staff issues,
shortages, temporary help, other problems with staffing as
contributing to the error.
Ms. Capps. So that it would be possible maybe, as we are
beginning to wrap up this hearing, to say that one of the areas
in which we can focus our attention to addressing medication
errors could be with some staffing issues, dealing with the
shortages, dealing with the workplace situations that impede
with all of the technology that you have developed. Anyone else
want to comment on that, I would be happy.
Mr. O'Leary. Well, I will just comment. We have actually
had an expert roundtable on the nurse staffing issue in place
since last November, and one of the basic messages, I think,
coming out of that is that America's nurses need to want to go
to work in the morning, and the environment in which they are
working now is not that environment.
There are a lot of issues there, but the thing that I am
encouraged by is the success of the magnet hospital program----
Ms. Capps. Yes.
Mr. O'Leary. [continuing] which tells me that it is
possible. There are magnat hospitals with waiting lists for
nurses in the face of this shortage, and these are environments
in which others delegated authority to the floor nurse. There
is attention to flexible scheduling. There is not mandatory
overtime, because they don't need mandatory overtime, and all
of the irritants have been addressed.
This kind of modeling, I think, holds out a lot of hope for
the rest of America.
Ms. Capps. In other words, the irritants, stress,
shortages, do contribute to medical errors?
Mr. O'Leary. And we know that from our data base. While you
were out, 24 percent of the adverse events in our data base
relate directly to insufficient staff, and another almost twice
that relate to inadequate training and orientation for the
kinds of things that are being done today. This is very real.
Ms. Capps. I appreciate that you gave us the bright note,
because there are many instances. We are focusing today on
problems, on errors, on shortages, but when it comes together
with the right kind of symmetry, it can be a marvelous thing to
behold.
Mr. O'Leary. Yes, it can.
Ms. Capps. Thank you. I yield back.
Mr. Bilirakis. And referring again to the RNs and the piece
of legislation we are considering is, we feel, very, very
important and very much needed.
Having said that, I also see some efforts being made on the
local basis toward this. I know what used to be a junior
college in our area is now a 4-year community college with
emphasis on training nurses, teachers, nurses, particularly
those two areas where there is such a shortage.
I was commencement speaker at the graduation the other
night, Monday night, and there was maybe a page and a half full
of RNs graduating, which is, I thought, terrific. I am not
saying that that is the sole answer, but that is certainly a
part of it. So there are other nongovernment groups out there
also who see this shortage and who are trying to address it.
Well, all right. That terminates this hearing. Again, I
apologize for that great big gap of time that you had to wait.
The least we could have done is told you to take time to go get
something to eat, but we--or buy them lunch. I misjudged. But
in any case, thank you so much.
Again, as per usual, we will be submitting written
questions to you, and hopefully, you will respond to those
written questions in a timely fashion to help us out here.
Again going back to that question I asked about
legislation, any ideas toward that end, if we don't know what
your thoughts are toward that end, we can't, obviously,
consider it. Thank you very much.
The hearing is adjourned.
[Whereupon, at 1 p.m., the subcommittee was adjourned.]
[Additional material submitted for the record follows:]
Prepared Statement of American Academy of Orthopaedic Surgeons
The American Academy of Orthopaedic Surgeons (AAOS), representing
18,000 board-certified orthopaedic surgeons, appreciates Chairman
Bilirakis' efforts to hold a hearing to address health quality and
patient safety. AAOS has long supported initiatives to reduce medical
errors and improve the quality of health care for all health care
recipients.
AAOS has designated the elimination of medical errors as a high
priority in our policies and practices, and, as a result, has committed
significant financial and clinical resources to educate our members in
the practice of safe care. We are pleased to share highlights of our
work over the past several years to reduce or eliminate specific types
of surgical errors.
In 1997, we launched the ``Sign Your Site'' initiative, an
education program that urges surgeons of all surgical specialties to
mark the operative site, in consultation with the patient, as part of
their pre-surgery routine. This protocol has the overwhelming support
of our members, who believe this program will prevent wrong-site
surgery. Numerous hospitals throughout the country have responded
positively to this campaign, and mandatory ``Sign Your Site'' programs
have been initiated at an increasing number of hospitals. AAOS supports
the ``Sign Your Site'' initiative as a required protocol for every
hospital seeking certification by the Joint Commission on the
Accreditation of Healthcare Organizations (JCAHO). We also believe that
a unified effort among surgeons, hospitals and other health care
providers to initiate pre-operative and other procedures will help to
prevent surgical error.
Since 1990, the AAOS Committee on Professional Liability has
conducted a series of closed-claim professional liability insurance
studies, through on-site retrospective review of the records of
insurance companies across the country, in order to assist orthopaedic
surgeons in providing optimum patient care. Several orthopaedic
diagnoses and procedures have been reviewed, including foot and ankle
surgery, spine surgery and spine fusion, total hip and knee
replacement, knee arthroscopy, fractures of the hip, femur and tibia,
and pediatric problems, and have resulted in the publication of two
books and numerous articles that have identified trends in unexpected
outcomes and medical errors and provided risk management. From these
studies, we have been able to establish or clarify appropriate
treatment protocols and methods of operation, enabling us to promote
safe and appropriate surgical practice. This guidance emphasizes
thorough patient consent discussions about treatment options and
alternatives, risks of treatment, non-treatment, and patient
expectations regarding eventual functional ability after treatment.
The AAOS Board of Directors recently created a ``Patient Safety
Committee'' within the organization to promote safe practices and to
reduce and prevent adverse events that could occur in orthopaedic
practice. This permanent committee will undertake several initiatives
over the next few years to enhance member and patient knowledge about
safe medical practices. A few of the Committee's goals include the
development of educational programs and communication publications that
will alert our members to potential medical product and drug
interaction complications; development of a curriculum on patient
safety for adoption into residency and fellowship programs; and
development of working relationships with other professional societies
and federal agencies that will focus on community based and national
collaborative initiatives for implementation of patient safety
improvements. A major charge to the Committee will be the continued
education of AAOS members to achieve a culture of safety within their
practice and to incorporate patient safety considerations into practice
guidelines.
AAOS also remains a recognized leader in the process of Continuous
Quality Improvement (CQI), an important cornerstone of our strategic
plan that helps us provide ``Best Care'' to our patients. We have
developed a comprehensive patient education program that will empower
patients by encouraging them to take control of managing their own
health care and increased communications to the public about the AAOS'
own commitment to this effort. The AAOS Committee on Evidence Based
Medicine remains focused on developing clinical practice guidelines and
performance measures to improve quality and efficiency of care, which
can be used to assist physicians in diagnosis and treatment decisions.
In addition to our internal education efforts, we continue to look
beyond our own organization to work with Federal agencies and other
health care organizations that support efforts to reduce medical
errors. The Department of Health and Human Services' Agency for
Healthcare Research and Quality (AHRQ) dedicated itself under the
leadership of Director John Eisenberg, MD, to conduct and disseminate
research in order to improve the outcomes, quality, access, cost and
utilization of health care services. We have maintained a dialogue with
key AHRQ staff to continue to provide input into their research efforts
and medical error projects, and AAOS Fellows have participated in
discussions surrounding the formation of a key AHRQ initiative, the
Patient Safety Task Force. This Task Force has begun to evaluate and
explore ways to minimize the burden of reporting adverse events and
errors and to explore the development of a single, coordinated system
for collecting data that would be easy to use and would provide
reliable, valid information.
We also are active participants in the National Quality Forum
(NQF), a not-for-profit public-private membership organization
established to develop and implement a national strategy for health
care quality measurement and reporting.
AAOS, as part of a large group of national health care
organizations, developed a set of key principles and safeguards that we
believe should be incorporated into voluntary patient safety reporting
systems. These principles call for: the creation of a non-punitive
environment for safety reporting that focuses on preventing and
correcting systems as opposed to laying blame on individuals or
organizations, a comprehensive analysis of data to identify where
improvements can be made and new protocols should be developed,
assurance of confidentiality protections for patients, healthcare
professionals and organizations, the ability to disseminate and share
patient safety information to facilitate positive improvements, and
federal protection for reporting system information. We believe it is
critical that data collected and shared for the purposes of improving
patient safety be privileged, or use of patient safety reporting
systems may ultimately be discouraged. (Please see attached listing of
principles.)
As the Subcommittee evaluates appropriate responses to prevent
patient harm and minimize health systems errors, policies should
encourage a constructive partnership between the federal government,
hospitals, physicians, and other medical providers and personnel. These
public and private initiatives should be encouraged through a non-
punitive, cooperative environment, and should take a system-wide
approach that ensures patient confidentiality and appropriate legal
protection of all information involved in patient safety reporting
systems. Before instituting new reporting systems, AAOS encourages
federal and state governments to determine through initial,
scientifically sound research whether and how existing reporting
programs have led to a reduction in medical errors.
AAOS thanks Chairman Bilirakis, Ranking Member Brown, and the
members of the Subcommittee for holding this important hearing. We
stand ready to work with the Subcommittee and other Members of Congress
to ensure safe practices in our health care system.
General Principles for Patient Safety Reporting Systems
1. Creating an Environment for Safety. There should be a nonpunitive
culture for reporting healthcare errors that focuses on
preventing and correcting systems failures and not on
individual or organization culpability.
<bullet> Healthcare professionals and organizations should foster a
positive atmosphere that encourages the submission of
healthcare error reports to public or private oversight
organizations, accrediting bodies, an official compendial body,
or other generally recognized patient safety reporting systems.
The existence of a reporting system does not relieve healthcare
professionals and organizations of their responsibility to
maintain professionally recognized standards of care.
2. Data Analysis. Information submitted to reporting systems must be
comprehensively analyzed to identify actions that would
minimize the risk that reported events recur.
<bullet> Systems within organizations should be scrutinized to identify
weaknesses and processes that make healthcare errors possible
or likely to occur, and to identify actions to prevent future
errors. Effective procedures and/or protocols developed through
reporting systems should be compiled and widely disseminated to
all healthcare professionals and organizations.
3. Confidentiality. Confidentiality protections for patients,
healthcare professionals, and healthcare organizations are
essential to the ability of any reporting system to learn about
errors and effect their reduction.
<bullet> Reporting systems should protect the identity of individual
patients and abide by all relevant confidentiality laws and
regulations. The identities of healthcare professionals and
organizations involved in errors should not be disclosed
outside a reporting system without consent.
4. Information Sharing. Reporting systems should facilitate the sharing
of patient safety information among healthcare organizations
and foster confidential collaboration with other healthcare
reporting systems.
<bullet> Sharing information is fundamental to a reporting system's
ability to achieve widespread improvements in patient safety
and to instill a confidence in the public that safety issues
are being addressed. Sharing of error-related information is
subject to the confidentiality principle.
<bullet> The causes of errors and their solutions must be widely shared
so that all healthcare organizations can learn from the
experiences of others.
<bullet> In some circumstances, it will be desirable to share reports
of errors among reporting systems, and with other appropriate
quality improvement entities, in order to accomplish root cause
analyses, to construct action plans, and to engage in other
efforts to enhance patient safety.
5. Legal Status of Reporting System Information. The absence of federal
protection for information submitted to patient safety
reporting systems discourages the use of such systems, which
reduces the opportunity to identify trends and implement
corrective measures. Information developed in connection with
reporting systems should be privileged for purposes of federal
and state judicial proceedings in civil matters, and for
purposes of federal and state administrative proceedings,
including with respect to discovery, subpoenas, testimony, or
any other form of disclosure.
(a) Scope. The privilege for the information prepared for a
reporting system should extend to any data, report, memorandum,
analysis, statement, or other communication developed for the purposes
of the system. This privilege should not interfere with the disclosure
of information that is otherwise available, including the right of
individuals to access their own medical records.
(b) No Waiver. The submission of healthcare error information to a
reporting system, or the sharing of information by healthcare
organizations or reporting systems with third parties in accordance
with these principles, should not be construed as waiving this
privilege or any other privilege under federal or state law that exists
with respect to the information.
(c) Freedom of Information Act. Healthcare error information
received by and from reporting systems should be exempt from the
Freedom of Information Act and other similar state laws. Such an
exemption is necessary to preserve the privilege discussed in this
principle.
(d) Impact on State Law. A federal law is necessary to assure
protection of information submitted to national reporting systems, but
the federal protection should not preempt state evidentiary laws that
provide greater protection than federal law. Providing such information
to reporting systems should not constitute a waiver of any state law
privilege.
______
Prepared Statement of American Federation of Labor and Congress of
Industrial Organizations
On behalf of the working men and women of the AFL-CIO, we
congratulate Chairman Tauzin and Members of the Committee for
conducting this hearing on such a vitally important aspect of our
health care system: reducing medical errors. The AFL-CIO represents 13
million members and their families. We are purchasers and consumers of
health care; many are also working on the front lines of patient care.
Reducing medical errors and ensuring patient safety is an issue that
affects us all.
A recently released report from The Commonwealth Fund estimated
that nearly 23 million people have experienced a medical error of some
kind, either personally or through a family member. Those numbers echo
the findings of a highly regarded 1999 Institute of Medicine (IOM)
report that found up to 98,000 deaths occur each year as a result of
medical errors at a cost of $29 billion. IOM further found that the use
of information technology is key to reducing medical errors and
improving quality health care delivery.
With today's hearing, the committee will examine ways technology
can be used to help reduce medical errors, saving both lives and health
care resources. One such technology--computerized physician order entry
(CPOE) systems--ensures that patients are not prescribed dangerous
combinations of medication and are given the appropriate medication in
the proper dosage. Some studies have found the use of CPOE systems have
reduced medication errors by as much as 88 percent. The AFL-CIO
supports legislation that would provide grants to hospitals and skilled
nursing facilities to purchase information technology specifically
designed to reduce medication errors, including CPOE systems. The
Medication Errors Reduction Act, H.R. 3292, is currently in the Energy
and Commerce Committee.
However, as important and effective as this technology is, it is
just one part of what must be a comprehensive effort to reduce medical
errors and prevent avoidable injury and death. Another IOM report found
medical errors to be the result of poorly designed systems, rather than
careless mistakes of individual health care providers. Following the
lead of those industries that have significantly improved their safety
records, the IOM report noted that restructuring health care workplace
systems so that they are geared towards safety would play a vital role
in reducing medical errors. One way to do this is by developing a
system for reporting errors in a blame-free environment, which would
allow for the root cause analysis necessary to identify system-wide
solutions to compromised patient safety.
A comprehensive approach to reducing medical errors will also
address the link between patient safety and poor working conditions,
including personnel shortages and requiring nurses to work overtime in
order to solve gaps in staffing. The Joint Commission on Accreditation
of Healthcare Organizations has found that when examining serious
medical errors, almost one quarter of them have inadequate nurse
staffing as a major underlying factor. Faced with insufficient
staffing, many employers have opted to require nurses to work overtime.
Not only is this practice of mandatory overtime making the nurse
shortage more acute, it is compromising patient care. The capacity to
deliver high quality care is seriously compromised when nurses are
exhausted from long hours of work and insufficient time off. The
likelihood of making an error in judgment, misreading a patient chart,
or missing an important indicator while observing or examining a
patient increases significantly when nurses are exhausted.
We urge the committee to consider these additional steps to
reducing medical errors and ensuring patient safety. We support your
efforts here today and would like to work with the Members of the
Committee to develop and enact a comprehensive solution that will
benefit health care institutions and workers, as well as the patients
they serve.
______
Prepared Statement of David G. Schulke, Executive Vice President,
American Health Quality Association
The American Health Quality Association represents independent
private organizations--known as Quality Improvement Organizations
(QIOs)--that hold contracts with the Centers for Medicare and Medicaid
Services (CMS) to improve the quality of care for Medicare
beneficiaries in all 50 states and U.S. territories.
Congress created the QIO network to monitor and improve the quality
of care delivered to Medicare beneficiaries and supports the work of
the QIOs with about $300 million annually from the Medicare Trust Fund.
In the early years of the program, QIOs were known as Peer Review
Organizations and focused on utilization management and quality
assurance. However, over the past decade QIOs have dramatically changed
their approach.
QIOs today work directly and cooperatively with hospitals and
medical professionals across the country to implement quality
improvement projects that address the root causes of medical errors.
QIOs today are working to accomplish what this committee--in its
announcement of this hearing--suggests should be a major bipartisan
goal: resolving endemic problems that result from failing systems of
care.
QIOs are improving the quality of health care not only by targeting
errors of ``commission''--medical errors that make the headlines--but
also by systematically working with medical professionals to reduce
errors of ``omission'' that result in care that falls short of
evidence-based medicine. Examples of errors of omission include failure
to administer antibiotics prior to major surgery, or failure to
prescribe ACE inhibitor drugs to appropriate heart failure patients.
why the qio approach works
QIOs are local organizations, employing local professionals, with a
national mandate to improve systems of care. As such, QIOs act as
catalysts for change trusted by both beneficiaries and providers. QIOs
educate beneficiaries about preventive care and encourage hospitals and
doctors to adopt and build into daily routines ``best practices'' for
treating seniors with common and serious medical conditions.
Medical professionals work voluntarily and often enthusiastically
with QIOs because QIO projects reduce duplication of effort and burden
on doctors participating in multiple hospitals and health plans. These
projects also reduce the burden on hospitals that participate in
multiple health plans, by bringing the parties together to work on the
same urgent clinical priorities, using the same measures, the same
abstraction tools, the same key messages. Even the best consultants
working for individual hospitals cannot have this effect--and many
providers cannot afford costly consultants. In short, QIOs accelerate
diffusion of evidence-based medicine to all providers--small, large,
urban and rural.
what qios have accomplished
QIOs use data to track progress towards eliminating errors and
improving treatment processes. They use data to measure hospital and
provider performance on a list of clinical indicators over the course
of a QIO project, and then compare results to baseline data to document
change.
From 1996-1999, QIOs worked on local projects to improve clinical
indicators in care for diseases and conditions that broadly afflict
seniors' heart attack, congestive heart failure, stroke, pneumonia,
diabetes, and breast cancer. Results from these projects show that QIOs
have already made a significant difference. The latest available
national data (1996-1998) show QIO projects resulted, for example, in:
<bullet> 34% more patients getting medications to prevent a second
heart attack;
<bullet> 23% more stroke patients receiving drugs that prevent
subsequent strokes;
<bullet> 12% more heart failure patients getting treatment needed to
extend their active lives;
<bullet> 20% more patients hospitalized with pneumonia receiving rapid
antibiotic therapy.
In 1999, CMS launched a national campaign for QIOs to improve care
for cardiovascular conditions, pneumonia, diabetes, and breast cancer.
The campaign began with creation of the first national quality portrait
for Medicare. This baseline data showed considerable room for
improvement in standard care in the six targeted clinical areas.
The baseline data for heart attack treatment, for example, shows
the following percentages of patients (by state) receiving evidence-
based care:
------------------------------------------------------------------------
Clinical Process Best State Worst State
------------------------------------------------------------------------
Prompt aspirin administration............... 97% 67%
Aspirin at discharge........................ 97% 60%
Prompt beta blocker administration.......... 79% 33%
Beta blocker at discharge................... 93% 47%
------------------------------------------------------------------------
Recent re-measurement of a significant segment of this national
data (for 19 states) indicates that QIO interventions are having
substantial impact. For example, initial re-measurement data on
reducing system failures in the treatment of heart attacks and
pneumonia show:
------------------------------------------------------------------------
Median State
Heart Attack Clinical Process Improvement
------------------------------------------------------------------------
Prompt aspirin administration............................. 16%
Aspirin at discharge...................................... 18%
Prompt beta blocker administration........................ 26%
Beta blocker at discharge................................. 26%
------------------------------------------------------------------------
------------------------------------------------------------------------
Median State
Pneumonia Clinical Process Improvement
------------------------------------------------------------------------
Antibiotic within 8 hours................................. 8%
Appropriate antibiotic administration..................... 29%
Pneumococcal vaccination.................................. 15%
------------------------------------------------------------------------
Besides participating in the national campaign to improve care in
these six critical areas, QIOs are working to improve care in rural
areas, to improve care for minority and ethnic populations, and to
cooperate more closely with community-based groups that focus on better
health care. QIOs are also working with nursing homes on the prevention
of pressure sores, fall prevention, pain management, development of
quality measures for rehabilitation services, improving diabetes
outcomes, improving anticoagulant use, and conducting state-wide
immunization campaigns.
qio confidentiality requirements
The confidentiality of information collected or developed by a
Medicare QIO is assured by Section 1160 of the Social Security Act. It
was the intent of Congress in drafting this provision to provide
safeguards for information identifying a specific patient, practitioner
or reviewer. These safeguards foster an environment that is conducive
to quality improvement efforts and learning from errors.
Generally, the disclosure of data or information collected or
developed by a QIO in carrying out its functions for Medicare is
strictly prohibited. This information is not subject to subpoena or
discovery for the purposes of an administrative or civil action.
Further, the law states that any individual who violates the
prohibition is subject to criminal fines and/or imprisonment.
The law does provide exceptions for QIOs to disclose to specific
individuals or entities information that may identify providers or
practitioners. Under certain circumstances, QIOs may provide such
information to the practitioner or the institution where the
practitioner works, State licensure and certification agencies, fraud
and abuse or public health officials. These entities may only disclose
information obtained from a QIO in the context of a judicial,
administrative or other formal legal proceeding resulting from an
investigation conducted by the agency. All of these exceptions are for
the intended purpose of identifying and protecting the public from
substandard care, fraud or abuse.
The confidentiality of QIO quality improvement efforts has helped
establish a relationship of trust with providers. Currently, nearly 80%
of Medicare hospitals nationwide are working with QIOs on one or more
quality improvement projects. QIOs have also had some success working
with outpatient physician offices, nursing homes and home health
agencies. Efforts in the non-hospital settings will increase
significantly over the next few years.
The QIO approach to improving care is voluntary, educational,
collaborative and non-punitive. Through this approach, QIOs have
assisted providers and practitioners in identifying quality issues and
instituting appropriate changes to bring about measurable improvement.
This process has achieved significant improvements in the quality of
care for Medicare beneficiaries--and improving systems of care with
Medicare participating practitioners and providers improves care for
all patients.
looking ahead
CMS recently announced new directions for QIO efforts over the
2002-2004 contract period. National QIO quality improvement efforts
will be expanded beyond the six original clinical areas to include care
provided by nursing homes and home health agencies, reduction of
surgical site infections in hospitals, and work with physicians offices
on improving care for chronic diseases and preventive services such as
cancer screening and adult immunizations.
QIOs will also be deeply engaged in a new CMS initiative to educate
consumers with quality information to help them choose higher quality
providers and motivate poor performers to improve. While CMS will be
publishing the data, QIO efforts will be critical to public
comprehension and use of the data. Nursing homes motivated to improve
performance will receive QIO technical assistance to implement
strategies that have worked in similar settings.
recommendation
We urge the Committee to take closer note of what this program has
accomplished and to verify its value through discussions with leaders
of the medical community. We look forward to working with the Committee
as it considers legislation to improve the quality and safety of
Medicare.
______
Prepared Statement of the American Medical Association
On behalf of our physician and medical student members, the
American Medical Association (AMA) appreciates Chairman Bilirakis'
initiative in calling this hearing today to discuss the important issue
of patient safety and quality of care.
The issue of safety and quality of care for patients in our
nation's health care system has long been a concern of the AMA. The
elimination of health system errors is not only a high priority for the
AMA, it is also an important ethic of the medical profession. As an
association founded on the commitment of physicians to improving the
quality of medical care, we believe that any error that harms a patient
is one error too many.
ama's commitments to patient safety and quality improvement
The AMA has been a pioneer in the effort to reduce health care
system errors and ensure that our patients receive safe, quality health
care. For example, in 1996, the American Association for the
Advancement of Science, the Joint Commission on Accreditation of
Healthcare Organizations (JCAHO), and the AMA joined with the Annenberg
Center for Health Sciences to convene the first multidisciplinary
conference on errors in health care. Since that time, several
initiatives in patient safety have been undertaken at the state and
national level, such as preventing patient injuries due to medication
errors. Given the importance of this issue, in 1997 the AMA also
established the National Patient Safety Foundation (NPSF), a broad-
based partnership of health care clinicians, consumer advocates, health
product manufacturers, public and private employers and payers,
researchers, regulators, and policymakers, which is now an independent
not-for-profit organization. Through leadership, research support, and
education, the NPSF is committed to making patient safety a national
priority.
In 1999, the public's attention became further focused on the issue
of patient safety and quality of care when the Institute of Medicine
(IOM) released its report entitled, To Err is Human: Building a Safer
Health System. While much of the information in the 1999 IOM report is
not new, there is much that is new and exciting in the public and
private sector's response to the issues raised in that report. For
instance, the AMA has been working in a concerted manner with the
federal government on several of its initiatives to improve patient
safety. In 2001, Health and Human Services (HHS) Secretary Tommy
Thompson created the HHS Patient Safety Task Force, comprised of the
Agency for Healthcare Research and Quality (AHRQ), the Centers for
Medicare and Medicaid Services (CMS), the Food and Drug Administration
(FDA), and the Centers for Disease Control and Prevention (CDC). Under
the dedicated leadership of John Eisenberg, MD, Director of AHRQ, the
Task Force has pursued an ambitious effort to create a federal
confidential, non-identifiable database of information collected on
patient safety events so that important research can be conducted and
shared and interventions can be designed to prevent future health care
errors. The AMA serves in an official advisory role to the Task Force
and its important work. The AMA also is a founding member of, and a
liaison board member to, the National Quality Forum (NQF), a public-
private partnership created in 1999 that seeks to develop consensus
among key stakeholders in the private sector as well as state and
federal governments on performance measures and patient safety
practices to improve health care quality.
The AMA believes health professionals and organizations should be
encouraged to report and evaluate health care errors and to share their
experiences with others in order to prevent similar occurrences. We
also believe that true reform must include all components of the health
care system and not focus only on individual components. Hospitals,
physicians, nurses, pharmacists, drug and device manufacturers, nursing
homes, and others must all work together to identify, study, and solve
system-wide problems that could cause errors or adverse outcomes.
Towards this end, in 2000 the AMA joined with over 20 other national
health care organizations to form a coalition to develop a set of
General Principles for Patient Safety Reporting Systems (see attachment
A) that constitute the five essential elements of effective reporting
systems. The General Principles underscore the point that, for error
reporting systems to be successful, they must be constructed in a non-
punitive manner that provide appropriate confidentiality protections.
Currently, over 90 national and state-based health care organizations
have endorsed these principles (see attachment B).
In 2001, the IOM released a report entitled, Crossing the Quality
Chasm: A New Health System for the 21st Century. This report calls for
action to ``improve the American health care delivery system as a
whole, in all its dimensions of quality, for all Americans.'' The AMA
supports the 2001 IOM report's central conclusion that innovative
changes are needed within the current health care system to ensure all
Americans receive high quality care. As the report states, many of the
current problems cannot be solved simply by asking physicians and other
health care professionals to try harder. Real, meaningful systemic
change is needed.
The AMA shares the IOM's view that health care should be safe,
effective, patient-centered, timely, efficient, and equitable. In fact,
many AMA programs and initiatives are already addressing these areas of
concern. As discussed above, the AMA is a leader in addressing patient
safety issues. In addition, the AMA is involved in several efforts
aimed at helping physicians adopt evidence-based clinical guidelines in
caring for their patients. Key efforts include: the National Guideline
Clearinghouse <SUP>TM</SUP> (NGC <SUP>TM</SUP>)--sponsored by the AMA,
AHRQ, and the American Association of Health Plans (AAHP)--offering an
internet-based repository of clinical practice guidelines designed to
assist physicians in their clinical decision-making; the Practice
Guidelines Partnership (PGP)--composed of 13 of the largest national
medical specialty societies, AMA, AHRQ, American Hospital Association,
JCAHO, and CMS--is working together to identify issues relevant to
appropriate development, evaluation, and implementation of clinical
practice guidelines; the Clinical Quality Improvement Forum (CQIF)--
hosted annually by the AMA--brings together national experts in
clinical quality to share information that health care professionals
can use in their own work to improve patient care; the Quality Care
Alert (QCA)--a collaborative effort by the AMA and specialty societies
that results in concise mailings and Web site postings to alert
physicians to important gaps between medical knowledge and practice;
and the Physician Consortium for Performance Improvement--convened by
the AMA--brings together clinical content and methodology experts from
over 50 medical specialty societies, AHRQ, and CMS to identify and
develop clinical measures that result in improved patient care.
Further, the Collaborative is a cooperative effort of JCAHO, the
National Committee for Quality Assurance, and the AMA to identify and
promote clinical performance measures.
These efforts are important pieces of a larger puzzle. As the 2001
IOM report makes clear, transforming the current system cannot rest
solely on the shoulders of health care professionals. There needs to be
a broad commitment from all sectors if the goals and the vision put
forth in the 2001 IOM report are to be achieved. In our quest to
improve the current system, however, we must not disrupt all the good
things happening in medicine today. Despite its systemic problems, our
health care system is still the best in the world. The 2001 IOM report
is a call to all of us to develop a system that can deliver the promise
of high quality health care to all our patients. The AMA stands ready
and willing to do its share and we look forward to working with others
to build a better health care system for all Americans.
recent federal activity to advance patient safety and improve quality
There have been several notable efforts at the federal level to
address patient safety and quality of care issues over the past few
years. In fact, Congress has already taken several steps to move toward
creating a ``culture of safety.'' A few years back, Congress passed
specific legislative language to reduce errors in the health system. In
December 1999, the Healthcare Research and Quality Act of 1999 (P.L.
106-129) was enacted into law to reauthorize the AHRQ (formerly AHCPR).
In Section 912(c) of this law, Congress clearly showed its commitment
to reduce errors in the health care system by, inter alia, directing
AHRQ to conduct and support research and build private-public
partnerships to: ``(1) identify the causes of preventable health care
errors and patient injury in health care delivery; (2) develop,
demonstrate, and evaluate strategies for reducing errors and improving
patient safety; and (3) disseminate such effective strategies
throughout the health care industry'' (emphasis added).
When Congress created the Medicare Payment Advisory Commission
(MedPAC) as part of the Balanced Budget Act of 1997, it directed MedPAC
to look at issues related to quality of care for Medicare
beneficiaries. Accordingly, MedPAC's June 1999 Report to Congress
contains seven recommendations to Congress addressing the issue of
``health care errors under Medicare.'' In its report, MedPAC recommends
that the Secretary of HHS establish patient safety as a quality
improvement priority for Medicare and take steps to minimize
preventable errors in health care delivery.
More recently, Congress has provided additional funding for patient
safety research. In its fiscal year 2001 budget, the AHRQ was
appropriated $50 million to: further understand when, how, and under
what circumstances errors occur; identify the causes of errors; develop
tools, data, and research needed to foster a national strategy to
improve patient safety; and work with public and private partners to
apply evidence-based approaches to the improvement of patient safety.
In fiscal year 2002, AHRQ received additional funding to work with CDC,
FDA, and CMS in developing a common vocabulary to link existing patient
safety reporting systems and to assist those who develop such systems.
Also, in February 2001, the AHRQ announced it would fund up to 13
cooperative agreements to sponsor demonstration projects to assess the
effectiveness of various methods of collecting and using information to
reduce errors. AHRQ is awarding $25 million annually in fiscal years
2001-2003 to support these agreements. Further, in January 2001, the
AHRQ changed the name of its Center for Quality Measurement and
Improvement to the Center for Quality Improvement and Patient Safety
(CQuIPS) to reflect the AHRQ's new responsibilities for patient
safety--consistent with the 1999 IOM report.
current patient safety reporting systems
Currently about 20 states have enacted some reporting mechanism for
health care errors. State programs vary considerably with regard to the
types of reports required, with some involving anonymous submission of
aggregate data and others involving individual, named incident reports.
In some states, participation is mandatory, while in others it is
voluntary. A number of medical specialty societies also have
sophisticated programs that collect information about patient outcomes,
adverse events, and other quality indicators. Perhaps most well known
is the Closed Claims Project of the American Society of
Anesthesiologists.
On a national level, the United States Pharmacopoeia has
implemented a voluntary medication error reporting program, known as
MedMarx. This program is guided by the National Coordinating Council
for Medication Error Reporting and Prevention. The FDA has implemented
the MedWatch reporting system for serious adverse events associated
with medical products. The Department of Veterans Affairs has a number
of health system error reporting projects, and the aviation industry is
often cited as an example from which important lessons can be learned.
The National Transportation Safety Board has an Accident/Incident
Database, which applies only to data on actual aviation accidents.
Aviation safety incidents (near misses) are voluntarily reported under
the Aviation Safety Reporting System (ASRS), which is funded by the
Federal Aviation Administration and administered by the National
Aeronautics and Space Administration. The ASRS collects, analyzes, and
responds to voluntarily submitted aviation incident reports,
maintaining confidentiality, in order to lessen the likelihood of
future accidents. The success of this system is based on its approach
of looking for solutions to prevent future accidents, not on
establishing blame.
Congress should consider the effectiveness of these existing
programs in searching for workable and sound policies and procedures
that promote the collection of data that are valid and reliable and
which, ultimately, resulted in improved patient safety.
creating a culture of safety though federal legislation
The AMA strongly supports the principal underlying the 1999 IOM
Report that the health care system needs to transform the existing
culture of blame and punishment that suppresses information about
errors into a ``culture of safety'' that focuses on openness and
information sharing to improve health care and prevent adverse
outcomes. The AMA also supports the 1999 IOM's focus on the need for a
system-wide approach to eliminating adverse outcomes and improving
safety and quality, instead of focusing on individual components of the
health system in an isolated or punitive way.
This transformation to a ``culture of safety'' requires the
initiative of Congress to pass legislation that will encourage
reporting of health care errors without the fear of punishment. We
believe that the primary goal of patient safety legislation should be
to facilitate the development of a confidential, non-punitive, and
evidence-based system for reporting health care errors so that such
errors can be identified and analyzed to improve patient safety by
preventing future errors.
The general approach should allow the AHRQ to certify entities to
collect error reports from health care providers (e.g., hospitals) and
providers of services (e.g., physicians), analyze such reports, provide
direct feedback to the providers, and make recommendations on ways to
reduce errors. The certified entities could also report non-identified
information on improving patient safety directly to the AHRQ. The AHRQ
would act as the lead agency for the dissemination of information
learned about reducing errors and improving patient safety and the
quality of care.
For an error reporting system to be truly effective, it is
essential that reports on health care errors remain confidential
(except for consensual sharing of information with other certified
entities) and privileged (i.e., not subject to discovery or subpoena).
Currently, information about errors is not adequately shared because of
fear among health care professionals and organizations of legal
reprisal. The absence of federal protections for information reported
to a certified entity would discourage participation in such a system
and impede patient safety improvement efforts. The integrity of a
certified entity could be ensured by allowing the AHRQ to rescind
certification if regulatory standards are not maintained.
In such a system, only health care error reports developed for
reporting to a certified entity would be protected--the underlying
facts of any error event, medical records, and documents maintained
separately from the error reporting system would not be protected. All
information that is required to be reported under state or any other
law would not be affected, and any information that is subject to legal
discovery under current and future laws would remain discoverable.
There is a very broad and strong consensus of agreement on this
legislative approach among the organizations that endorsed the General
Principles for Patient Safety Reporting Systems. Also, there are
efforts in the Senate to develop a federal patient safety reporting
system consistent with this approach. We support these efforts and
encourage the House to adopt a similar approach.
MedPAC and JCAHO have made recommendations to Congress that are
consistent with the approach outlined above. The June 1999 MedPAC
Report recommends that Congress enact legislation ``to protect the
confidentiality of individually identifiable information relating to
errors in health care delivery when that information is reported for
quality improvement purposes.'' The IOM Report states that MedPAC's
recommendation is a ``promising alternative.'' Likewise, JCAHO has
testified that it has been seeking federal legislative protection to
protect from disclosure information developed in response to a sentinel
event and shared with an accreditor.
The matter of accountability for negligent or incompetent actions
is already well established in our health care and judicial systems for
physicians and other health care providers. State and Federal courts,
state licensing boards, and accrediting bodies such as JCAHO all
function to maintain accountability and standards. However, the very
fear of existing legal liability or its misapplication are the greatest
hurdles to pioneering patient safety efforts.
For example, when the Anesthesia Patient Safety Foundation was
founded, legal liability was a major concern. The creative approach
employed by the anesthesiologists was to start by looking at claims
that have already been settled or closed. Unfortunately, waiting for a
case to settle or close before a problem can be discussed without the
fear of litigation needlessly delays important feedback that otherwise
could result in an immediate solution. Congress can help create a
culture of safety by allowing medical professionals to convene to
discuss patient safety problems and potential solutions without having
their discussions, findings, or recommendations become the basis for
class action or other lawsuits. If the fear of litigation continues to
pervade efforts to improve patient safety and quality, our
transformation into a culture of safety on behalf of our patients may
never be fully realized.
Non-punitive approaches have yielded useful results in related
contexts. For example, Congress should consider the experience of the
past several decades in preventing hospital-acquired infections. With
the scientific support of the CDC and AHRQ, hospital epidemiologists
and physicians specializing in hospital-based infectious diseases have
systematically undertaken thousands of investigations of endemic and
epidemic infections. These studies have been done in a blame-free
environment in which learning was the major goal. The infection
controllers observed that spontaneous reporting of infections and
broad, voluntary surveillance provided misleading information. They
recognized the need for targeted, systematic surveillance and focused
objectives for the infection control program, as well as for simple,
clear definitions of infections. Hospital-acquired infection rates have
declined precipitously as a result of these efforts.
conclusion
The AMA believes that true reform must include all components of
the health care system and not focus only on individual components.
Hospitals, physicians, nurses, pharmacists, drug and device
manufacturers, nursing homes, and others must all work together and be
encouraged to work together to identify, study, and solve system-wide
problems that could cause errors or adverse outcomes. Our common goal
must be to detect errors and system barriers to make corrections before
a patient is harmed.
Adding more regulation and more mandates is not the answer to
improving patient safety and quality. It is important for Congress to
recognize the efforts already being implemented in both the public and
private health care delivery systems before passing legislation. When
and if legislation is enacted, we must all be certain that it will
support and enhance the initiatives already underway, and not set back
these efforts. As stated in the 1999 IOM Report, a system must be
designed to detect, prevent, and minimize health care system hazards to
reduce errors. This can be achieved best by first acknowledging that
the vast majority of health care system errors are not intentional and
must be distinguished from truly negligent behavior. The focus must
remain on reforming the system, not punishing the individual. We must
collectively focus our efforts on identifying solutions that benefit
patients.
Nationwide dissemination of the identified solutions would do a
great deal to improve the safety of the nation's health care system. As
it has done with dissemination of practice guidelines, Congress should
support the AHRQ's charge to disseminate current information on patient
safety and prevention of adverse events, and provide sufficient grants
to research currently available data.
The AMA is committed to continuing and redoubling our efforts to
work with Congress and our partners in the health care system to
achieve a system in which patients are assured of safe, quality health
care. We appreciate having the opportunity to submit this statement for
the Record and commend Chairman Bilirakis and this committee for
focusing on needed improvements in patient safety and quality of care.
Attachment A
general principles for patient safety reporting systems
1. Creating an Environment for Safety. There should be a nonpunitive
culture for reporting healthcare errors that focuses on
preventing and correcting systems failures and not on
individual or organization culpability.
<bullet> Healthcare professionals and organizations should foster a
positive atmosphere that encourages the submission of
healthcare error reports to public or private oversight
organizations, accrediting bodies, an official compendial body,
or other generally recognized patient safety reporting systems.
The existence of a reporting system does not relieve healthcare
professionals and organizations of their responsibility to
maintain professionally recognized standards of care.
2. Data Analysis. Information submitted to reporting systems must be
comprehensively analyzed to identify actions that would
minimize the risk that reported events recur.
<bullet> Systems within organizations should be scrutinized to identify
weaknesses and processes that make healthcare errors possible
or likely to occur, and to identify actions to prevent future
errors. Effective procedures and/or protocols developed through
reporting systems should be compiled and widely disseminated to
all healthcare professionals and organizations.
3. Confidentiality. Confidentiality protections for patients,
healthcare professionals, and healthcare organizations are
essential to the ability of any reporting system to learn about
errors and effect their reduction.
<bullet> Reporting systems should protect the identity of individual
patients and abide by all relevant confidentiality laws and
regulations. The identities of healthcare professionals and
organizations involved in errors should not be disclosed
outside a reporting system without consent.
4. Information Sharing. Reporting systems should facilitate the sharing
of patient safety information among healthcare organizations
and foster confidential collaboration with other healthcare
reporting systems.
<bullet> Sharing information is fundamental to a reporting system's
ability to achieve widespread improvements in patient safety
and to instill a confidence in the public that safety issues
are being addressed. Sharing of error-related information is
subject to the confidentiality principle.
<bullet> The causes of errors and their solutions must be widely shared
so that all healthcare organizations can learn from the
experiences of others.
<bullet> In some circumstances, it will be desirable to share reports
of errors among reporting systems, and with other appropriate
quality improvement entities, in order to accomplish root cause
analyses, to construct action plans, and to engage in other
efforts to enhance patient safety.
5. Legal Status of Reporting System Information. The absence of federal
protection for information submitted to patient safety
reporting systems discourages the use of such systems, which
reduces the opportunity to identify trends and implement
corrective measures. Information developed in connection with
reporting systems should be privileged for purposes of federal
and state judicial proceedings in civil matters, and for
purposes of federal and state administrative proceedings,
including with respect to discovery, subpoenas, testimony, or
any other form of disclosure.
(a) Scope. The privilege for the information prepared for a
reporting system should extend to any data, report, memorandum,
analysis, statement, or other communication developed for the purposes
of the system. This privilege should not interfere with the disclosure
of information that is otherwise available, including the right of
individuals to access their own medical records.
(b) No Waiver. The submission of healthcare error information to a
reporting system, or the sharing of information by healthcare
organizations or reporting systems with third parties in accordance
with these principles, should not be construed as waiving this
privilege or any other privilege under federal or state law that exists
with respect to the information.
(c) Freedom of Information Act. Healthcare error information
received by and from reporting systems should be exempt from the
Freedom of Information Act and other similar state laws. Such an
exemption is necessary to preserve the privilege discussed in this
principle.
(d) Impact on State Law. A federal law is necessary to assure
protection of information submitted to national reporting systems, but
the federal protection should not preempt state evidentiary laws that
provide greater protection than federal law. Providing such information
to reporting systems should not constitute a waiver of any state law
privilege.
The following organizations support these principles (as of May
2001): Academy of Managed Care Pharmacy; American Academy of Child and
Adolescent Psychiatry; American Academy of Dermatology; American
Academy of Facial Plastic and Reconstructive Surgery; American Academy
of Family Physicians; American Academy of Neurology; American Academy
of Ophthalmology; American Academy of Otolaryngology--Head and Neck
Surgery; American Academy of Physician Assistants; American Association
for Thoracic Surgery; American Association of Health Plans; American
Association of Neurological Surgeons; American Association of
Orthopaedic Surgeons; American Association of Pharmacy Technicians;
American College of Cardiology; American College of Chest Physicians;
American College of Emergency Physicians; American College of Medical
Quality; American College of Nuclear Physicians; American College of
Nurse-Midwives; American College of Obstetricians and Gynecologists;
American College of Osteopathic Family Physicians; American College of
Osteopathic Surgeons; American College of Physicians-American Society
of Internal Medicine; American College of Preventive Medicine; American
College of Radiology; American College of Surgeons; American Geriatrics
Society; American Health Care Association; American Health Quality
Association; American Hospital Association; American Medical
Association; American Medical Group Association; American Nurses
Association; American Osteopathic Association; American Pharmaceutical
Association; American Psychiatric Association; American Society for
Therapeutic Radiology and Oncology; American Society of
Anesthesiologists; American Society of Cataract and Refractive Surgery;
American Society of Clinical Oncology; American Society of Clinical
Pathologists; American Society of General Surgeons; American Society of
Health-System Pharmacists; American Society of Plastic Surgeons;
American Urological Association; College of American Pathologists;
Congress of Neurological Surgeons; Connecticut State Medical Society;
Federation of American Hospitals; Hawaii Pharmacists Association;
Healthcare Leadership Council; Idaho Medical Association; Institute for
Safe Medication Practices; Iowa Medical Society; Joint Commission on
Accreditation of Healthcare Organizations; Kentucky Medical
Association; MedChi, The Maryland State Medical Society; Medical
Association of Georgia; Medical Group Management Association; Medical
Society of Delaware; Medical Society of the District of Columbia;
Medical Society of New Jersey; Medical Society of the State of New
York; Michigan State Medical Society; Minnesota Medical Association;
Mississippi State Medical Society; Missouri State Medical Association;
National Association of Psychiatric Health Systems; National Committee
for Quality Assurance; National Patient Safety Foundation; New
Hampshire Medical Society; New Mexico Medical Society; North American
Society of Pacing and Electrophysiology; Ohio State Medical
Association; Oncology Nursing Society; Oregon Medical Association;
Oklahoma State Medical Society; Premier; Renal Physicians Association;
Rhode Island Medical Society; Society of Critical Care Medicine;
Society of Nuclear Medicine; Society of Thoracic Surgeons; South
Carolina Medical Association; South Dakota State Medical Association;
State Medical Society of Wisconsin; Texas Medical Association; U.S.
Pharmacopeia; Utah Medical Association; VHA, Inc.; Washington State
Medical Association; and Wyoming Medical Society.
______
Prepared Statement of the American Society for Clinical Pathology
The American Society for Clinical Pathology appreciates this
opportunity to comment on patient safety, an issue of great importance
to the pathology and laboratory community. This statement focuses on
private patient safety initiatives within the pathology and laboratory
medicine field, and shows how health care quality may improve as a
result.
The American Society for Clinical Pathology (ASCP) is a nonprofit
medical specialty society representing 151,000 board certified
pathologists, other physicians, clinical scientists (PhDs), medical
technologists and technicians. It is the world's largest organization
representing pathology and laboratory medicine. As the leading provider
of continuing education for medical laboratory personnel, the ASCP
enhances the quality of the profession through comprehensive
educational programs and materials.
The purpose of the ASCP is to improve public health by advancing
the science and practice of pathology and laboratory medicine. Patient
safety is an important part of this principle. To continue its
leadership role in advancing patient safety, ASCP has developed a
Patient Safety Initiative, which encompasses every part of the
laboratory.
Transfusion Medicine Protocols
Transfusion medicine laboratory professionals have a long tradition
for error detection and prevention systems by following standard
operating procedures and conducting audits. While the proper
application of these complex processes is critical to transfusion
safety, dependency on numerous, diverse human interactions makes these
processes prone to accidents and errors. Blood administration-related
accidents and errors--which occur outside the confines of blood bank/
transfusion service laboratory--represent a significant cause of
transfusion morbidity and mortality. In the ongoing quest for improved
transfusion safety, it is imperative that blood transfusion process
safety be accorded the same emphasis as blood component safety.
To address this issue, ASCP joined with the American Organization
of Nurse Executives in a Patient Safety Transfusion Medicine Project
Team to identify seven essential components of the blood transfusion
process. The joint project team developed flow charts and standard
operating procedure checklists to assist hospital personnel in
assessing the status of their own processes and procedures and take
necessary actions to close gaps that may compromise blood transfusion
safety. The preliminary results of this joint patient safety project
were unveiled last month at a workshop sponsored by the Food and Drug
Administration and the Agency for Healthcare Research and Quality.
Minimum Standards Necessary
The Centers for Medicare and Medicaid Services (CMS) found in a
recent survey that 32% of waived laboratories failed to have current
manufacturer's instructions, 16% didn't follow the manufacturer's
instructions, 9% didn't follow manufacturer's storage and handling
instructions, and 6% were using expired reagents and kits. This
preliminary information is based on a survey conducted by CMS from
October 2000 to January 2001. The results showed overall that a
substantial 48% of waived laboratories surveyed had quality testing
problems. The survey results were produced from an expanded pilot
project undertaken by the agency of 270 certificate of waiver
laboratories and 190 provider-performed microscopy laboratories
surveyed in eight states.
Standards for clinical laboratory testing such as quality control,
quality assurance, personnel standards, proficiency testing, and site
neutrality should not be eroded as they have helped to raise the
standard by which all laboratories operate. Problems that are
identified can and are being corrected with the help and guidance of
federal and private inspectors.
Use of the Autopsy
The autopsy is an important quality control vehicle. For example, a
study published in the August 1998 issue of the American Journal of
Clinical Pathology found that of 176 autopsies examined in a major
tertiary care transplantation referral center, 79 autopsies, or 44.9%,
revealed one or more undiagnosed causes of death. There were 123
undiagnosed causes of death in the 79 cases. Of the 123 undiagnosed
causes of death, 13 were sole immediate causes of death, 72 were one of
multiple immediate causes, 22 were intervening causes, and 16 were
underlying causes of death. Low-technology autopsies frequently
discover diagnoses that go undetected by modern high-technology
medicine. Through the autopsy, problems in diagnosis may be recognized
and ultimately assist in finding solutions to similar medical problems
in future patients.
To accommodate better the needs and concerns of family members,
hospitals should develop a coherent set of policies that explain the
usefulness of an autopsy. ASCP suggests that these policies may
include: developing an informational pamphlet that is made available to
the patient's family, describing the autopsy procedure and its values;
creating an office of decedent affairs within the hospital organization
to assist dying patients, families and involved members of the medical
staff to understand the details surrounding dying and death in the
hospital environment; and creating in-service programs to ensure that
nurses and social workers provide assistance in facilitating any
efforts to obtain an autopsy consent.
The ASCP firmly believes that the autopsy is necessary to monitor
the clinical judgment in the medical community. For quality assurance
purposes alone, the autopsy is a critical service. Any condition of
participation addressing the autopsy should also assure appropriate
compensation for this service.
Second Opinions in Diagnostic Anatomic Pathology
As part of its Patient Safety Initiative, ASCP hosted the
``Consensus Conference on Second Opinions in Diagnostic Anatomic
Pathology: Who, What and When'' on June 21, 2000, in Washington, DC.
The conference, which was open to the public, convened with pathology
experts of various disciplines, surgical representation, and a patient
advocate. The conferees worked to reach a consensus on what specimens
should be reviewed under second opinions, whose opinion prevails upon a
second review, when a second opinion should occur, and to develop
general guidelines for second opinions in diagnostic anatomic
pathology.
The conference determined that second opinion is an important
component of total quality assurance programs in diagnostic surgical
pathology and cytopathology and is a key aspect in the assurance of
patient safety for tissue and cytology based diagnoses. The conference
urged the implementation of educational programs to inform clinicians
and patients regarding the value of second opinion; the turn around
time delays which second opinion will produce, and the legitimate
differences of opinion that can exist in difficult cases.
It was recommended that all insurers provide a fair reimbursement
structure for second opinion services, and that funding agencies
support research into the detailed analysis of second opinion as a
patient safety mechanism and that academic pathology centers should
engage in such research. Overall, the effective use of second opinion
in diagnostic anatomic pathology is a subject that needs to be better
communicated to clinicians and patients.
Conclusion
Pathology and laboratory medicine have developed and continue to
support the use of quality processes for the systematic detection and
prevention of errors. These efforts concentrate on building safety into
the delivery of health care, similar to the recommendations of the
Institute of Medicine Committee on Quality of Health Care in America.
Many patient safety initiatives, such as those recognized in donor
blood testing and autopsies, have been absorbed by the laboratory
profession in the interest of maintaining and improving quality. As new
efforts are disseminated, it will be important that custodians of those
efforts receive the resources they need to accomplish the task.
Thank you for the opportunity to provide this statement to the
subcommittee.
______
Prepared Statement of American Society of Radiologic Technologists
Mr. Chairman and members of the Committee: On behalf of the 96,000
members of the American Society of Radiologic Technologists (ASRT) and
the millions of patients we serve, I want to thank you for this
opportunity to contribute to this dialogue on the role technology plays
in reducing medical errors and improving patient safety.
Radiologic technologists are the health professionals responsible
for performing diagnostic imaging examinations and for planning and
delivering radiation therapy treatments. Radiologic technologists use
some of the most complex equipment in the medical field, including
magnetic resonance scanners, computed tomography units and positron
emission tomography machines. The images that radiologic technologists
obtain with this equipment are used to diagnose many diseases and
injuries.
Remarkable advances have been made in medical imaging technology
during the past few years. However, the technology is ineffective
unless the health care professional operating it is capable of
maximizing its potential. Every medical imaging examination is
operator-dependent. In other words, the diagnostic quality of any
medical image is directly linked to the skill and competence of the
person who obtained the image. Individuals must have extensive
education and training to perform the exam correctly.
Because our members have a key role in diagnosis, the ASRT is
committed to finding ways to reduce medical errors in the radiology
arena. Accurate diagnosis leads to recovery and cure, while inaccurate
diagnosis leads to additional testing, delays in treatment and extended
suffering by the patient. In addition, diagnostic errors cost the U.S.
health care system millions of dollars annually in unnecessary medical
bills.
The ASRT strongly believes that the best way to improve the quality
of radiologic care is to improve the qualifications of the caregivers.
That is why the ASRT, along with 17 other radiologic science
organizations, supports the Consumer Assurance of Radiologic Excellence
bill (H.R. 1011). The CARE bill would establish minimum educational and
credentialing standards for personnel who plan and deliver radiation
therapy and who perform all types of medical imaging examinations
except sonography. The ASRT believes the establishment of these
standards will have a significant beneficial impact on the safety of
patients undergoing radiologic procedures, as well as reduce the number
of medical errors caused by improper diagnosis. The CARE bill will
ensure that personnel are qualified to operate the high-tech equipment
that has been entrusted to them.
More than 220,000 registered radiologic technologists work in the
United States. Registered radiologic technologists graduate from an
accredited educational program, pass a national certification
examination and obtain continuing education in their field.
Unfortunately, thousands of unqualified individuals also work in the
medical imaging field. That's because 12 states and the District of
Columbia do not license people who provide medical imaging or radiation
therapy services. In states where no regulations exist, anyone is
permitted to perform these procedures, sometimes after just a few weeks
of on-the-job training. And even in states that do regulate radiologic
technologists, some of the licensing laws are so weak that they offer
patients little protection from unqualified personnel.
The Consumer Assurance of Radiologic Excellence bill would protect
patients by requiring personnel to prove that they are qualified,
through education and credentialing, to perform radiologic examinations
and deliver radiation therapy treatments. The CARE bill has 49
cosponsors in the U.S. House of Representatives.
Currently, mammography is the only medical imaging procedure
regulated by the federal government. In 1992, the Mammography Quality
Standards Act (MQSA) set educational, credentialing and experience
guidelines for the personnel who obtain and interpret mammograms. Many
question why the personnel who obtain mammographic images are
regulated, while those who obtain x-ray, MRI and CT images are not.
Mammography makes up only 8 to 10 percent of the total number of
medical imaging procedures performed in the United States annually.
``While this emphasis on quality in breast imaging is laudable,
[evidence] suggests that more attention needs to be devoted to
improving the quality of the other types of x-ray exams as well,''
stated a 1992 article.\1\
More than 300 million radiologic examinations are performed
annually in the United States, at an annual cost of nearly $22
billion.\2\ If only 0.5 percent of those medical images is performed
improperly, more than 4,000 defective medical images would be produced
every day of the year.
To Err is Human, the Institute of Medicine's 1999 report on patient
safety, states that 17 percent of preventable medical errors are errors
in diagnosis.\3\ The ASRT believes that a significant number of these
diagnostic errors may be attributed to poorly performed medical imaging
examinations. After all, an underexposed chest x-ray cannot reveal
pneumonia, just as a poor quality MRI scan cannot reveal a malignant
lesion. Poor imaging examinations are a threat to patient health and
safety.
Dr. Lucian Leape, a professor at the Harvard School of Public
Health and a chair of the IOM commission that produced the To Err is
Human report, estimates that physicians misread 20 percent of
angiograms and 15 percent of chest x-rays for pneumonia.\4\ In many of
these cases, it is likely that the films presented to the physician are
misread because their technical quality is poor. In a 1990 article
concerning the misdiagnosis of lung cancer,\5\ researchers at Michigan
State University wrote, ``If the quality of the image is so poor that a
reasonably responsible and prudent radiologist would not have
interpreted it, then poor image quality alone may be a source of
negligence.'' A poor technique produces films with little or no
diagnostic value.
Because the technology used in the radiology department is so
complex, most patients would not recognize incompetence or poor quality
work. ``If an illness is not detected as early as it could have been
because of a shoddy x-ray . . . the patient probably never knows it,''
according to an article in the Dec. 24, 1999, Birmingham News.\6\ ``The
reason public outcry is not louder and malpractice suits more common is
that most patients have no idea they may be getting substandard care.''
Errors made by unqualified personnel can result in unreadable
images, which may have disastrous ramifications for the patient. The
patient may be required to undergo additional unnecessary tests, he may
receive treatment for a condition he does not have, or he may receive
no treatment at all. In each scenario, the patient's health and safety
are threatened.
The simplest and best way to improve the quality of radiologic care
is to establish educational and credentialing standards for the
personnel who perform the exams. Licensing and credentialing radiologic
personnel would build reliability and consistency into the way medical
images are obtained and help standardize their level of quality. Only
qualified, competent personnel should be allowed to perform these
procedures.
The Consumer Assurance of Radiologic Excellence bill (H.R. 1011)
will ensure a minimum level of education, knowledge and skill for those
who perform radiologic procedures. Ultimately, it will improve the
quality and safety of patient care.
REFERENCES
\1\ Edmiston RB, Levin DC. Film quality assessment varies among
specialties. Diagnostic Imaging. July 1992.
\2\ Sunshine JH, Mabry MR, Bansal S. The volume and cost of
radiologic services in the United States in 1990. American Journal of
Roentgenology. September 1991.
\3\ Institute of Medicine. To Err Is Human: Building a Safer Health
System. National Academy Press, Washington, D.C. 1999.
\4\ Leape L. Error in medicine. Journal of the American Medical
Association. Dec. 21, 1994.
\5\ Potchen EJ, Bisesi MA. When is it malpractice to miss lung
cancer on chest radiographs? Radiology. January 1990.
\6\ Gerome J. Group seeks licensing for x-ray technicians.
Birmingham News. Birmingham, Ala. Dec. 24, 1999.
______
Prepared Statement of the American Society for Quality
During the last decade, steadily mounting evidence has focused on
the problems of prescription drug errors. We now have a great deal of
knowledge of what the problems are and their causes, and yet these
problems persist. Adverse events resulting from medical mismanagement
are estimated to affect anywhere from 1% to 30% of hospitalized
patients \1\<SUP>,</SUP>\2\; of these, drug-related complications are
the most common type of adverse event.\3\ An estimated one-fourth to
one-half of all adverse drug events among hospital patients are the
result of medication errors.\4\<SUP>,</SUP>\5\ The annual cost of these
drug errors is estimated at $3-4 billion.\6\ And one in three Americans
say they have been affected by serious medical mistakes, of which 28%
involve a medication error.\7\ What seem to be lacking are widely
accepted methods for dealing with the problems and solid commitment for
following through.
This paper proposes methods for dealing with these shortcomings--
methods arising out of multidisciplinary perspectives for dealing with
complex systems. It also makes a case for making smart use of
technology-based solutions to prescription drug problems and for
addressing cultural factors that hinder advances in reducing medication
errors.
A set of broad principles underlying quality improvement in health
care can be found in a position paper \8\ written by the Health Care
Quality Special Interest Group of the American Society for Quality's
Health Care Division and the Society for Healthcare Epidemiology of
America. Those principles relate to prescription drug errors as well as
the entire range of health care quality issues and form a basis for
many of the points raised here. That position paper is attached and
should be considered an integral part of this report.
Complex Systems
The seemingly simple act of prescribing and dispensing medication
is actually part of a highly complex system in which errors can appear
at many points. The entire process encompasses everything from
manufacture and distribution through dispensing and use, and errors
affecting the safety of the patient who takes the drug can occur at any
of several points. Many of these errors arise as a result of poorly
designed complex systems. This was a principle conclusion of the now
widely known Institute of Medicine report titled To Err Is Human:
Building a Safer Health System.
Headway in reducing prescription drug errors will come only when a
critical mass of people on the front lines and in administrative
decision-making positions gain understanding of these complex systems
and working knowledge of an array of tools meant to be applied to the
design, analysis, and operation of complex systems. Clearly, in our
health care delivery systems we have not yet reached that critical
mass.
Tools
These tools can be broadly classified into two main types: the
tools of process management and the tools of quality management. Among
the former are tools and techniques for breaking down any system,
simple or complex, into its essential processes, revealing inputs and
outputs at various points in the process, ``customers'' and their
requirements, key relationships, and measurements at appropriate points
that will indicate if actual improvements have been made.
Basic quality tools such as control charts and simple problem-
solving tools are known to have widespread applicability in health care
settings. Two especially promising methodologies for health care
applications are Failure Mode and Effects Analysis (FMEA) and Root
Cause Analysis.
FMEA, primarily a system design tool, is used to identify and
prevent known and potential problems from reaching the customer--in
this case, the patient receiving the medication. It begins with a
process map of the system and proceeds to catalog ways in which things
could go wrong in the system. The causes and effects of each failure
mode are identified. These potential failures are assigned a risk
priority by evaluating their likely severity, detectability, and
frequency of occurrence. Prioritizing potential failures points the way
to making the most effective changes in a system design or in an
existing system.
Root Cause Analysis identifies the most basic reasons for an
undesirable condition--and the most obvious opportunities for
improvement in present operations and for preventing problems or faults
from being introduced into the system in the first place.
Any quality tools must, of course, be applied within a logical
framework for improvement. Such a framework is provided by several
complementary approaches: the Baldrige criteria, the ISO 9000 quality
management system standards, and the Six Sigma methodology, which taken
together are three key drivers of quality in an organization and which
are finding increased use in health care.
ISO 9000 is the approach that assures that a minimum standard of
quality is controlled in routine operations. This system of management
of quality does not by itself provide competitive advantage or assure
the long-term strength of an organization. It merely declares that the
quality system that is documented is being followed regularly.
Guidelines have been developed for the use of ISO 9000 quality
systems standards by health services organizations. IWA-1 Quality
Management Systems--Guidelines for Performance Improvements \9\ is
based on the ISO 9004:2000 standard. It contains much of the text of
ISO 9004:2000, supplemented by specific guidance for its implementation
in the health care sector. The guidelines provide a framework for the
design and improvement of process-based quality management systems by
health care organizations. The guidelines are voluntary and they are
not intended for certification or accreditation.
The value of ISO 9000 in health care is in the area of writing down
procedures and documenting. Clearly defined policies and procedures
that would pass muster in an ISO 9000 audit are not widely found in
most pharmacies. And it is not uncommon for different patient care
units and different shifts in the same organization to follow different
procedures for accomplishing the same medication goal. There are
currently more than 600 ISO 9000 registrations in health care
worldwide,\10\ and the number is rising.
The Baldrige performance excellence model focuses on enhancing
competitiveness by providing criteria for performance that represents
an aspiration level for most organizations, i.e., targets and practices
that stretch the thinking and approach of the organization's leaders.
Together, ISO 9000 and Baldrige assessment provide a lower control
limit and an upper target for performance.
When Six Sigma is added to this consolidated approach to quality,
the formula becomes much more complete. Unlike Baldrige and ISO 9000,
Six Sigma is a highly prescriptive approach for delivering quality in
the design of products and services and in the work processes that
deliver them. Six Sigma is a rigorous process for learning about the
sources of variation that cause defects in production processes,
service delivery mechanisms, and administrative procedures. Each step
in the Six Sigma problem-solving process requires the use of a
specified sequence of analytical tools in order to obtain profound
knowledge about process operations. Six Sigma is a methodology to
eliminate variation from work processes, which is precisely the aim of
efforts to reduce prescription drug errors.
There are a handful of hospitals in the United States that are
using the Six Sigma methodology. One of these, Froedtert Memorial
Lutheran Hospital in Milwaukee, showed significant improvement in
medication delivery by continuous IV infusion.\11\ Thirty days after
implementation of the Six Sigma strategy, Level 1 discrepancies fell
from 47.4% to 14%; Level 2 discrepancies fell from 21.1% to 11.8%; and
Level 3 discrepancies fell from 15.8% to 2.9%. The discrepancies were
classified into these three categories based on the deviation of the
actual infusion rate from the prescribed dose rate (Level 1 being less
than 1 ml/hr discrepancy and Level 3 being more than 5 ml/hr
discrepancy). Substantial efforts are ongoing to move toward the goal
of a six-sigma level of control.
It is instructive to note that Froedtert's was a multidisciplinary
effort among physicians, nurses, pharmacists, and administrators. The
group developed a process map that revealed nine key steps in the
administration of 22 medications delivered by continuous IV infusion.
Each of these steps was subjected to FMEA to identify the two most
error-prone steps in the IV infusion process, which became the target
steps for reducing errors. Root cause analysis was performed to
determine true causes of discrepancies in infusion rates.
The National Patient Safety Foundation and the American Society for
Quality recently formed an alliance to develop a Patient Safety
Toolbox. The major component of this project is the provision of Six
Sigma training for health care professionals.
Use of these tools is in its infancy in health care settings. While
there have been several published studies of the use of FMEA, there are
no published studies of continuing follow-up in these cases. There
appears to be inadequate commitment to the necessary steps of re-
measurement and continuing application beyond an initial demonstration
project and to making these steps standard procedure. Necessary system
changes have proven difficult to implement.
Rapid advances are being made in two areas that hold great promise
for reducing medication errors: technology-based solutions and
development of clinical guidelines and evidence-based best practices
models. Both of these are useful at the patient/provider interface,
where the art of medicine comes into play.
There is an array of new technological tools bringing helpful
changes at the patient/provider interface. Hand-held computers running
software such as ePocrates can provide on-the-spot, current information
about a medication. Physicians report that patients feel confident when
they see their physicians consulting this source of immediate
information. Other software such as i-Scribe is starting to make an
impact in reducing handwriting errors. And barcoded patient wristbands
also introduce a measure of error proofing into the system.
Understanding the science of human error and using that understanding
to error-proof system designs is an important step. Adoption of these
and other technological advances into physicians' practice patterns
needs to be systematically encouraged.
Clinical practice guidelines condense the knowledge of many
individuals and institutions. These evidence-based best-practices
models help the physician in his or her practice and are growing in use
and importance.
In the pharmaceutical manufacturing and distribution processes
there is a long history of the use of both simple and sophisticated
quality methods. Quality is sufficiently high that we almost take it
for granted, but there is a continuing need for vigilance in these
areas. Furthermore, manufacturers and distributors have a role to play
in efforts to reduce current levels of medication errors, particularly
in the areas of packaging and storage. Making look-alike and sound-
alike drugs different in their outward appearance, packaging, and
handling requirements can reduce the occurrence of human error in the
administration of drugs to patients.
Cultural Factors
For any of these approaches to take hold and have any lasting
effect, attention must first be paid to numerous cultural factors that
enable system-wide organizational change. First and foremost is the
need to establish a non-punitive environment in which causes for errors
can be examined and corrected, an environment where the emphasis is on
fixing and preventing problems rather than assigning blame. Instituting
policies and procedures that encourage self-reporting and discourage
disciplinary action for human error is a logical first step.
There must also be a willingness to routinely bring
interdisciplinary perspectives to bear on the challenges of reducing
prescription drug errors. When the problems call for smart design and
redesign of systems of work, much can be gained when physicians and
nurses, pharmacists, epidemiologists, administrators, academics, and
quality engineers join their skills and knowledge to the effort.
A growing body of knowledge relating to specific institutional
practices and procedures for reducing medication errors is arising out
of the work of groups such as the Institute for Healthcare Improvement,
National Patient Safety Foundation, American Society of Health-System
Pharmacists, and the Joint Commission on Accreditation of Healthcare
Organizations. It is not our purpose to repeat these well-documented
efforts. Rather, the important contribution we can make is to point the
way toward methodological approaches that these groups and others
interested in health care quality can implement in order to achieve
breakthroughs in reducing prescription drug errors.
Notes
\1\ Brennan, T.A., et al. ``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.
\2\ Bowman, L., et al. ``Incidence of Adverse Drug Reactions in
Adult Medical Patients.'' Canadian Journal of Hospital Pharmacy, Vol.
47 (1994), pp. 209-16.
\3\ Lesar, T.S., L. Briceland, and D.S. Stein. ``Factors Related to
Errors in Medication Prescribing.'' Journal of the American Medical
Association, Volume 277, Number 4 (1997), pp. 312-17.
\4\ Bates, D.W., et al. ``Incidence of Adverse Drug Events and
Potential Adverse Drug Events: Implications for Prevention.'' Journal
of the American Medical Association, Vol. 274, No. 1 (1995), pp. 29-34
\5\ Classen, D.C., et al. ``Adverse Drug Events in Hospitalized
Patients: Excess Length of Stay, Extra Costs, and Attributable
Mortality.'' Journal of the American Medical Association, Vol. 277, No.
4 (1997), pp. 301-06.
\6\ Leape, Lucian L., Andrea Kabcenell, Donald M. Berwick, and Jane
Roessner. Reducing Adverse Drug Events. Breakthrough Series Guide.
(Boston: Institute for Healthcare Improvement, 1998)
\7\ Louis Harris/National Patient Safety Foundation survey:
``Designing a Safer, Smarter Health care System.'' American Medical
News, October 27, 1997.
\8\ Birnbaum, David, Ron Berglund, Ulises Ruiz, and the Health Care
Quality Special Interest Group of the American Society for Quality's
Health Care Division and of the Society for Healthcare Epidemiology of
America. Quality and Quality Improvement in Health Care Services. 2001.
\9\ ISO/AIAG/ASQ. IWA-1:2001--Quality Management Systems:
Guidelines for Process Improvements in Health Service Organizations.
\10\ Reid, Ralph Daniel, and Marvin M. Christensen. ``Quality
Healthcare--A Path Forward.'' Transactions, 55th Annual Quality
Congress (Milwaukee: American Society for Quality, 2001)
\11\ Buck, Cathy. ``Application of Six Sigma to Reduce Medical
Errors.'' Transactions, 55th Annual Quality Congress (Milwaukee:
American Society for Quality, 2001)
______
Quality and Quality Improvement in Health Care Services
David Birnbaum, PhD, MPH, Ron Berglund, MPH, CHE, CQmgr, Ulises Ruiz,
MD, PhD, FACS and the Health Care Quality Special Interest Group* of
the American Society for Quality's Health Care Division and of the
Society for Healthcare Epidemiology of America
abstract
Recent national debates over methods to reduce errors in health
care have tended to ignore the pertinent heritage of early clinical and
administrative pioneers of quality in hospitals who had the courage to
``break the rules'' and innovate, hospital epidemiology, and the
industrial quality sciences. Critical appraisal of evidence in reports
fueling those debates, as well as in other documents; consideration of
all stakeholders' opinions; and development of effective solutions
requires interdisciplinary effort. We acknowledge that historic
improvements in public health quality have contributed significantly to
improving longevity and reducing the burden of many diseases; however,
the focus of this position paper is on acute care services. As a
profession, healthcare has been paralyzed. The system which we are
observing was 'designed' to produce the outcome we are measuring, and
no amount of policy tinkering or additional resources thrown at
measurement will have significant impact: well-considered structural
changes are required to prevent system failures. This position paper,
developed by an international, interdisciplinary group, examines
central issues and associated evidence to assist facilities and
healthcare professionals in responding to emergent challenges.
i. an interdisciplinary approach to improving health care quality
Specific conclusions and recommendations in the Institute of
Medicine's report To Err Is Human 1\1\ challenge us to build a system
of new processes that will create a ``Safer Health System''. As an
international, interdisciplinary group of academics, hospital
epidemiologists, infection control practitioners, management engineers,
medical administrators, nurses, pharmacists, physicians, and other
health professionals dedicated to improving health care services, we
are addressing issues raised by that body of work which apply to all
countries and include:
<bullet> National governments should set national goals for patient
safety, develop knowledge and understanding of errors in health
care, while funding the dissemination and communication of
activities to improve patient safety.
<bullet> There should be countrywide mandatory reporting systems that
would provide for the collection of standardized information by
regional governments about adverse events that result in death
or serious harm. Reporting should begin with hospitals and
expand to other health service organizations.
<bullet> There should be encouragement for the development of voluntary
reporting efforts including the review and coordination of
sponsors and users of external reporting systems.
<bullet> Peer review protection for data related to patient safety and
quality improvement should be expanded.
<bullet> Performance standards and expectations for health
professionals should focus greater attention on patient safety.
<bullet> Agencies that regulate drugs (e.g. US Food and Drug
Administration) should increase attention to the safe use of
drugs in both pre-and post-marketing processes.
<bullet> Health care organizations and professionals should, make
continually improving patient safety programs a declared and
serious aim that includes defined executive responsibility.
<bullet> Health care organizations should implement proven medication
safety practices.
While no one can disagree with the need to continuously improve
health services and organizations that provide them, the report's
dependence on government intervention, its implication that health care
professionals have not been paying attention to patient safety, and
even the estimated number of patient deaths attributed to errors, may
be misleading.\2\ When the problems of nonconformance, adverse
outcomes, and errors are examined from system, process, epidemiologic
and quality engineering perspectives, these problems frequently are
rooted in technical deficiencies of health care delivery systems rather
than isolated action of individuals alone. This is not a new
conclusion,\3\ having been addressed by WHO-Europe in 1982,\4\ and
through different perspectives of the traditional role and
responsibilities of care-
givers.\5\<SUP>,</SUP>\6\<SUP>,</SUP>\7\<SUP>,</SUP>\8\ Our position is
that permanent outcome improvement and error reduction are possible
only when deficient processes that make errors likely are
systematically improved through evidence-based approaches.
There are many lessons from decades of experience in hospital
epidemiology and infection control that apply to other types of adverse
outcomes in the broader context of health care service system failure.
SENIC (the Center for Disease Control's 10-year $12-million Study on
the Efficacy of Nosocomial Infection Control) assessed the cost-
effectiveness of hospital infection control programs and identified
those program elements associated with reducing patients' risk of
infection.\9\ Surveillance is a cornerstone of what has been called the
premier quality assessment program in United States hospitals,\10\ and
these proven surveillance methods have been applied beyond nosocomial
infection. Nettleman and Nelson, for example, employed standard
prospective surveillance methods to document frequency and distribution
of events that caused or had potential to cause patient injury, as well
as sensitivity, efficiency and cost of using different clinical
information sources.\11\ Epidemiology, which provides the scientific
basis for public health, has been successful in discerning complex
relationships in health care institutions but has been less successful
in promoting permanent system-wide changes there.
Traditional tools of quality control and quality management, proven
in monitoring and improving defined processes of other industries,
similarly had mixed success in national demonstration projects on
quality improvement in health care.\12\ Epidemiology is not
incompatible with these tools of monitoring and change,\13\ and in fact
provides a complementary aiming mechanism to better position their use
in the complexities of health care services.\14\ Novel
interdisciplinary approaches to improving quality have not been a
mainstream feature in health care, but are not
unprecedented,\15\<SUP>,</SUP>\16\<SUP>,</SUP>\17\ and have more
potential to succeed than the more common single-discipline,
prescriptive, rule-based approaches. However, to succeed in the future,
we need to understand why seemingly successful novel programs of the
past have not persisted to be today's paradigms.
The difficulties most likely to be faced when introducing and
implementing such concepts in the health care sector have been
described as ``early cynicism, issues of cultural fit to the complex
nature of the health care sector itself, and resistance from the
traditional professional identities of key role-holders'' \18\ and as
``quality being the flavor of the month, . . . a poor appreciation of
TQM concepts, principles and practices, . . . a lack of structure for
TQM activities and ineffective leadership.'' \19\ On the other hand,
many reports show successful introduction and use of various quality
tools and techniques in health care organizations. In a review of the
introduction of Total Quality Management (TQM) at a number of sites
within the UK National Health Service, it was found vital that the
medical staff, clinical directors, nurses and all health professionals
at all levels of the organization, and cross functionally, be involved
from the very beginning and that there needs to be ongoing education
and training. It also was found essential for senior managers to be
fully committed to the introduction of the chosen model and a carefully
planned implementation.\20\ Design and implementation of a Quality
Management Plan in the Spanish Health System also revealed some of the
advantages and obstacles described above,\21\<SUP>,</SUP>\22\ as also
found by a European study in 113 hospitals of 10 countries.\23\ Novel
interdisciplinary approaches have to be understood and applied as a
global culture change when introducing system and process thinking in
the daily operations of health services. Trying to apply traditional
tools and methods of quality without having set the appropriate
organizational cultural ground will be regarded by health professionals
as foreign and non-applicable, which may explain the mixed success of
these initiatives.\24\ Consequently new approaches are being
implemented in Spain,\25\ as elsewhere.
ii. definition of terms
Being a special interest group formed from societies with heritages
of industrial quality sciences and of epidemiology, we turn to those
directions for definitions. W. Edwards Deming, a luminary of modern
quality precepts, placed great emphasis on the need for clear
operational definitions. Epidemiology, similarly, achieves clarity when
technical terms are used precisely. We therefore choose to adopt terms
defined by established, internationally-recognized bodies including the
World Health Organization (WHO, which published pertinent definitions
on its web pages (http://www.who.int/aboutwho/en/definition.html &
http://www.who-umc.org/defs.html); the International Standards
Organization (ISO) and American National Standards Institute
(ANSI);\26\ International Epidemiology Association (IEA, which
published definitions in its dictionaries.\27\); and the US Institute
of Medicine (IOM).
Quality is more than just the absence of error. The definition of
quality in health care, as well as related terms (including
nonconformance, adverse outcome and error) can be viewed from five
perspectives:
1. scientific research
2. consumer of service (patients and the public at large)
3. dictionaries such as Webster's Medical Dictionary
4. accreditation, regulatory and other agencies or professional
associations
5. Type one and two errors and the potential impact of both
THE PERSPECTIVE OF SCIENTIFIC RESEARCH
Health and health care quality are multidimensional constructs.
Researchers create operational measures to define domains of these
constructs, as illustrated in Figure 2;\28\ working conditions and
worker satisfaction should be considered an additional domain of health
system performance measurement. We must be concerned as to whether
measures selected within each domain are sufficiently precise,
accurate, reliable, and meaningful to guide necessary decisions.
When we look at quality defined by scientific conclusion we look at
various disease rates including the ever-present nosocomial infection.
The assessment of health care quality is a complex problem. National
Committee for Quality Assurance (NCQA) reports and press releases note
improvement in quality ratings of organizations it surveyed last year,
and NCQA requirements have created an imperative for all health plans
to build the information systems needed to track and improve
performance. However, as we've learned from our experience monitoring
nosocomial infection rates, an overall or ``crude'' rate masks patterns
in its composite ``specific'' rates.\29\ Similarly, some aspects
monitored by NCQA show improvement while others show room for
improvement. Assurance of improvement in service quality requires
methods that can be applied in a wide range of settings.\30\ Meaningful
assurance also requires the type of ``Patient-Oriented Evidence that
Matters'' (POEMS) recommended by advocates of evidence-based health
care, and there is evidence suggesting that accreditation standing or
other typical measures are not highly correlated with consumers' rating
of care.\31\ Just as fundamental changes in health care delivery
systems are needed to reduce the risk of system failures, fundamental
changes in research funding and contracting models may be needed to
reduce the risk of misinformation.\32\<SUP>,</SUP>\33\ Scientific
research can answer questions, but we need to be sure the right
questions are being asked and answered.
THE PERSPECTIVE OF CUSTOMERS, CLIENTS, PATIENTS, AND THE GENERAL PUBLIC
A quality systems perspective typically considers quality as
satisfying both internal and external customers. All internal and
external customers don't necessarily see quality as an absence of
infections, a reduction in mortality rates, or an increase in trained
personnel. Each wants the health care services provider to meet their
own valid customer needs. As such, internal customers (health care
providers, departments and suppliers within the system) and external
customers (patients, their families and communities) have unique needs.
An organization has to assure that all its processes are controlled. A
care giver has to assure that their patients are adequately informed
about the products or service offered, the risks involved, and the
outcomes expected so that individuals looking to them for care can make
the most appropriate decision. Agreement between those who provide a
good or service and those who desire a good or service is the major
focus of any quality improvement approach, and is recognized as a
client-focus approach However, there is more to health care quality
than patient satisfaction alone, and satisfaction is a complex
construct that is not simple to survey meaningfully.\34\ Although it
recently became more common in health services to refer to patients as
clients or customers, we believe that this is still not well understood
terminology in the whole of the services sector. ``Customers'' brings
to mind the informed consumer of competitive economics. Referring to
patients as clients or customers may be misleading for health care
providers and consumers not familiar with contemporary quality
improvement terminology and approaches in health services for two
reasons. First, historically, patients know less about their condition
and the health care that might help them than their physician. The
physician is the patient's agent, and provides expert advice. Despite
efforts by groups like the international Cochrane Collaboration to
monitor and objectively assess the ever-growing body of research
literature,\35\ as well as quantitative and critical appraisal methods
applied by individual practitioners,\36\ much of that advice often must
be based on expert opinion in the face of incomplete evidence. Many
patients may be becoming better informed today, in no small part due to
development of internet-based resource sites and support groups, and an
informed customer is consistent with tenets of quality improvement
philosophies. However, quality of information from those resources is
quite variable, and the majority of individuals who seek health care
seek a special relationship with the professional who provides that
care. Second, patients do not value health care per se, they value
health; ``health care'' is an intermediate good that people consume
(based on expert advice) in hopes of deriving a health benefit. Many
patients, and especially those under duress of serious illness, do not
have the time, interest, or ability to gain sufficient knowledge to be
equally informed as their health care provider. So, no matter how much
information patients receive, choosing your surgery is never going to
be like buying a car. People can judge very well how well their car
works. The quality of their surgery (or other treatments) is much
harder to judge. The outcome of each surgery or treatment is clear and
self-evident as a success, partial success, or failure in meeting
expectations, but in most cases the technical issues pertaining to
quality are not as easy to judge on a case-by-case basis (viz. assuming
expectations were realistic, it is difficult if not impossible for
individuals to judge whether their condition would have improved anyway
without or despite the intervention; whether it failed to improve or
suffered adverse outcome due to subtle or transient differences in
skill or performance levels given the probabilistic rather than
deterministic nature of health care; or whether the best that a given
provider offers is commensurate with risk-adjusted performance of
providers elsewhere). All but the most flagrant technical problems
require population-based evaluation, the realm of epidemiology, and
state-of-the-art in meaningful risk-adjusted-metrics has raised
concerns about several so-called ``report card'' metrics. From the
perspective of some health economists, it is less subject to
misinterpretation to use the word patient when talking about someone
receiving care from a physician or other health care professional. Only
when we are explicitly talking about people choosing between, for
example, HMOs in the USA, or between health care professionals, or
deciding whether to buy supplemental insurance, then the health
economics perspective of ``customers'' could make sense. The special
nature of patient relationships requires holistic yet practical
approaches which engage ``the entire membership of individual health
care providers.'' \37\
Some health systems and organizations are at present using these
terms with increasing ease, once they have fully understood their
meaning. Indeed, in this spirit, the recent ISO Industry Workshop
Agreement 1 (IWA-1) document acknowledges the term ``patient-client''.
A related problem is changing the culture of the health sector. A
system or organization trying to change culture faces well-known
resistance of caregivers to loss of traditional role and
responsibilities. That is one reason why physicians have been
entrenched, up to not so long ago, in the classical technical quality
assurance approach where no challenge is accepted. This traditional
approach assures their role as patient's agent which overcomes the role
of the provider of expert advice. As provider, one has to discuss
advice with customers and reach an agreement with them about it.
Continuous Quality Improvement (CQI) might be able to reconcile the
trade-offs from both perspectives.\38\<SUP>,</SUP>\39\ However, at
present, referring to patients as clients or customers in an
organization with no CQI culture might be misleading.
The Henry Ford Healthcare System when approached by some of its
major automotive-industry customers decided to use the customers'
definition of a quality organization and they have seen better ``health
care measures'' and ``a noticeable increase in the number of clients
from the automobile industry wishing to use their facility''.\40\
THE PERSPECTIVE OF DICTIONARY DEFINITIONS
The definition of error based upon the medical dictionary states
that it is a ``deviation from right or truth; a mistake; a blunder;
sin.'' \41\ This is pretty strong language especially the ``sin'' part
when we look at our customers. ``Medical error'' is not defined in such
sources, and we do not consider pejorative dictionary definitions of
``error'' pertinent. We suggest that only dictionaries and definitions
published by well-recognized expert bodies (such as WHO, ISO, ANSI,
IEA) be considered.
THE PERSPECTIVE OF ACCREDITATION, REGULATORY AND OTHER AGENCIES OR
PROFESSIONAL ASSOCIATIONS
Adverse event (also known as adverse reaction or adverse outcome)
is defined by IEA. We accept the IEA definition to describe ``an
undesirable or unwanted consequence of a preventive, diagnostic, or
therapeutic procedure''; we recognize that further classification of
such events that do cause harm is consistent with the IOM definitions.
This definition of adverse event is also consistent with the more
recent ISO Industry Workshop Agreement (IWA-1) definition (``any event
which is not consistent with the desired, normal or usual operation of
the organization. Typically these are documented and require the
completion of an incident report''). If non-conformance is serious and
distinctive, the event can also be known as a ``sentinel event'' which
requires immediate corrective action.
Nonconformance is defined by ISO. We accept ISO and ANSI
descriptions of nonconformance, and recognize that further
classification of such events that could cause harm is consistent with
the IOM definitions. Depending upon the regulatory body, the definition
of error can go from a ``sentinel event'' to a missed signature on a
piece of paper even though all the required services were rendered.
Health care actions traditionally have been governed by policies,
procedures and clinical practice guidelines. Professional society and
institutional policies stipulate clear boundaries for acceptable
practice; violation of those boundaries is subject to disciplinary
action by professional colleges, societies, or institutional
administrations. Failure of such bodies to communicate with each other
has permitted continuing incompetent practice of individuals who
relocated, again a system failure. Institutional procedures define the
steps expected to complete an activity; while there may be choices
between procedures, deviation from steps within a procedure requires
justification (or, if frequent, a change in the written procedure).
Although some feel that deviation from clinical practice guidelines
constitutes error, there is longstanding evidence that such guidelines
do not guide practice,\42\<SUP>,</SUP>\43\ numerous examples of expert
consensus (as opposed to graded evidence) guidelines being inconsistent
with the underlying evidence; further, while such guidelines can form a
basis for audit, expert opinion holds that guideline-derived evaluation
represents ``a tool, not a rule'' to understand and inform rather than
coerce practice.\44\ We conclude that deviation from procedure or
practice guideline can be justified but requires documentation of
reason (a brief description of professional judgment); deviation per se
is not medical error, but failure to document or inadequate
justification may be.
We accept the IOM report definition of error (``failure of a
planned action to be completed as intended or the use of a wrong plan
to achieve an aim''),\1\ as well as its perspective that much can be
learned from the analysis of errors, not all errors result in adverse
events, and not all adverse events are preventable or the result of
error. Thus, error is one category of system failure in which
nonconformance through action, inaction, or incomplete documentation is
evident.
A more complete focus on quality and error reduction has been found
by several organizations that have moved from compliance to ongoing
systematic process control and improvement. Memorial Medical Center of
West Michigan in Ludington Michigan now uses the State of Michigan to
perform the required Medicare/ Medicaid certification and has developed
a clear set of customer expectations which not only meet customer
requirements but all Federal and State requirements while saving
thousands of dollars a year in external regulatory audits.\45\ This is
one example of the emerging use of ISO 9001:2000, ISO 9004:2000 and
IWA-1 as a basis for health care quality management systems, documents,
and standards.
THE PERSPECTIVE OF TYPE I AND TYPE II ERROR
Surveillance and screening programs are subject to two types of
misclassification error, which correspond to the two types of
statistical error: Type I (also known as alpha-error or producers'
risk) and Type II (also known as beta-error or consumer's risk). The
consequences of false-positive Type I error (unfairly damaged
reputations; excess cost of unnecessary inspection, investigation, and
possible rejection of good product; misguided changes to policy or
procedure) and false-negative Type II error (missed cases, with lost
potential to prevent injury or loss) must be considered to achieve
optimal balance. Although high sensitivity, specificity, and predictive
accuracy all are desired, when compromises are necessary surveillance
systems and screening programs typically place different emphasis on
these. Screening programs are designed to intervene in each case as
early as possible to avoid further harm, and tend to follow very
sensitive initial screens with a more specific confirmatory step (thus,
for example, programs to prevent medication error may be more concerned
with false-negative than false-positive initial assessments).
Surveillance programs are designed to monitor whether systems are
operating within expectation as well as detect incipient trends, but
trigger intervention on trends rather than on a case-by-case basis
(thus, for example, infection surveillance programs may be more
concerned with damage to credibility caused by false-positives so
emphasize specificity over sensitivity). Sensitivity and specificity
refer to the proportion of true cases and true non-cases correctly
identified, respectively. The CDC (Center for Disease Control &
Prevention) SENIC and NNIS (National Nosocomial Infection Surveillance)
programs have demonstrated the importance of clear, explicit target
event definitions as a requirement for effective surveillance or
screening programs. When we look at Type I or Type II errors the
question always gets back to the process in question. Finding the right
balance for each process in question is the key to producing cost-
effective programs. The Wayne Regional Orthopedics PLLC instituted a
new systematic approach to error reduction and improved quality which
during the installation year improved its customer satisfaction by 8%,
reduced its data entry errors from 30% to 10% and was able reduce
unnecessary staff costs.\46\
iii. causes and solutions for healthcare system failure
Healthcare is just recently returning to outcome-based assessment
of quality, first introduced by Ernest Codman in the early 1900s,
following decades of focus on standards to govern structure, process
and output alone.\47\ The complementary nature of epidemiology and
systems engineering techniques in this return has been noted.\48\ This
introduces concepts of processes, systems and system fundamentals. The
ISO Quality management system-fundamentals and vocabulary definition
states: ``Process--a set of interacting activities, which transforms
inputs into outputs.
Note 1. Inputs to a process are generally outputs of other
processes.
Note 2. Processes in an organization are generally planned and a
carried out under controlled conditions to add value.
Note 3. A process which the conformity of the resulting product can
not be readily or economically verified is frequently referred to as a
special process.'' \49\
This leads to a realization that the outcome we are measuring
reflects a misdesign or at least a lack of design of the system which
we are observing, and no amount of policy tinkering or additional
resources thrown at measurement will have significant impact: well-
considered structural changes are required to prevent system failures.
All stakeholders must be engaged in evidence-based review of
improvement priorities, system changes, and evaluation of the impact of
system changes: essentially, the familiar CQI Plan-Do-Check-Act cycle
(Figure 3) guided by approaches like ABNA,\15\ the IOM Model Process
for Technology Assessment,\50\ etc. Applied research, in-service
education, and ongoing training are essential components to create so-
called learning organizations that embody this (organizations that
learn and progress through continuous improvement of their processes).
Applied research in both the epidemiologic and CQI approaches
considers the framework of Structure-Process-Output-Outcome, while
other approaches that have been used in health care focus on Structure-
Process-Output regulation and simply assume causal relationships
between given regulated activity and desired outcome. Research has
shown that such assumptions have not always been valid, leading on
occasions to regulated activity that was not effective, cost-effective,
nor in some cases even safe. Assessing outcomes of a specific health
system, service, or institution requires an estimate of the best that
can be achieved (attainment) and of the least that can be demanded
(performance), given that the raison d'etre of a health system is to
protect and improve population health and not to thrive on disease.
Applied research and assessment of performance, in turn, must be linked
with assessment and delivery of effective education and training.
According to the ISO 9004:2000 IWA-1:
``Ongoing training--The organization should review qualifications
periodically to identify and provide necessary in-service training to
all instructors and staff to enable instruction personnel to carry out
their tasks with minimal supervision. If in-service is not available
and this impairs the quality of instruction, then a staff communication
procedure within the quality system should be considered to address
this. Records should show a periodic review of training needs.
NOTE: The prerequisites, objectives, standards of assessment,
instructional strategies, necessary controls, and the materials used
for instruction shall be available.
``Identification of patient family education/training programs--The
organization should use the results of an initial patient evaluation/
assessment and review of the patient health record, if any, to identify
training needs of the patient and/or family or others as appropriate.
The organization should maintain records of patient and/or family or
others training as appropriate. Where applicable, these records should
be included in the patient health record. The organization should
ensure that the patient and/or family or others can demonstrate the
ability to perform prescribed activities, if any. Any instruction plan
should require that conditions for learning include safe classrooms,
free of health hazards and physical distractions. Supporting services
should reinforce learning and not interfere with the learning
process.'' \51\
Human System response (special cause variation) may be defined as
how a human being responds to an assemblage of objects arranged after
some distinct method, usually logical or scientific (a system of
processes) based upon their training and experiences.
Quality Management Systems and their advantages require us to focus
on what a Quality Management System is and what advantages the various
existing systems present to ensure quality and reduce medical errors.
The most commonly defined systems include among others: ACHCS in
Australia, CCHSA in Canada, ANAES in France, ALPHA from ISQua, PACE and
NIAZ in Netherlands, HAPNZ in New Zealand, UKAS in UK, COHSASA in South
Africa, PAHO for South America, JCAHO, NCQA and URAC in USA; ISO
9001:94 and 9002:94 are being used as basic systems in Australia,
Finland, Ireland, Israel, New Zealand, Spain, Sweden, Switzerland, USA.
Our question is to decide if these sets of requirements and
guidelines constitute a management system or are they external
regulations designed to meet selected requirements of selected
customers. If we accept that they are selective in what they regulate
and not a complete system, then our focus will be easy. To build a
quality management system we would want to include the perspective
shown in Figure 1. This figure is taken from the IWA-1 which gained
world wide approval during ``An interactive ISO-sanctioned workshop
(which) took place in Detroit, MI, January 18-19.2001, involving 135
healthcare professionals representing 17 countries. IWA-1 will provide
guidelines to health service providers for implementing or improving
quality management systems (QMSs) based ISO on ISO 9004:2000 Quality
management systems-Guidelines for performance improvements.'' \51\
We will follow the lead of these 135 individuals if we request that
all health care services in the USA be subject to the HCFA Program
Safeguard, Statement of Work, Attachment J-1, Paragraph 10.A.3 and
become ISO compliant. Currently only American contractors annually
performing work totaling more than $1million under all Task Orders has
to become ISO compliant. Currently this involves over 30 organizations
including some Blue Cross/Blue Shield organizations. ISO 9001:94 and
9002:94 are being currently used in other countries around the world,
as indicated above. Our recommendation is that all health systems,
services and organizations within a five year period from the
publication of this document, will set in motion quality management
systems based upon the IWA-1 QUALITY MANAGEMENT SYSTEMS--Guidelines for
process improvement in health service organizations; Based on ISO
9004:2000 Second edition 2000-12-15 Quality management systems
``Guidelines for performance improvements (Systemes de management de la
qualite--Lignes directrices pour l'amelioration des performances. 1/19/
2001.)
iv. other logistical considerations
FINANCIAL IMPLICATIONS
Resource allocation for improvement activity is an important
consideration with two dimensions: Infrastructure to support infection
control and epidemiology departments as well as other service
units,\52\<SUP>,</SUP>\53\<SUP>,</SUP>\54\ and financial incentives as
well as non-financial incentives to change care provider practice
patterns. In the USA, despite the HMO movement, the majority of care is
still provided in the fee for service mode. Some feel that this does
not present individual providers' much incentive for efficiency and
appropriate levels of care. Others feel that the fee for service system
as implemented in the US engenders a lot of motivation for efficiency.
Reimbursements are relatively fixed, so providers must be efficient in
order to make money. Competition does stimulate efficiency; however, we
should be talking about effectiveness, too. There are no ``well baby
visit'' fee items in many health jurisdictions, nor other incentives to
spend more time doing a thorough job on health promotion and humane
support aspects of primary care. Fee for service doesn't encourage
primary care practitioners to provide non-fee-reimbursable services, to
refer out of system when in the patient's best interest but not the
Health Maintenance Organization's financial interest, nor to consider
more system-efficient approaches that aren't cost-effective for
individual physicians (e.g. renewing prescriptions over the phone
rather than billing for an office visit since only office visits are on
the fee schedule). On the other hand, salary without consideration of
efficiency and meaningful accountability or profit can breed
complacency, doesn't encourage facilities to innovate or reinvent
themselves to better meet stakeholders' needs. Perhaps we need to look
to other industries for models of employee ownership and profit-
sharing! One interesting suggestion in the last IOM report is to base
reimbursement on quality of service. At present, hospitals (and
doctors) get paid the same for doing things poorly. Payers fixated on
least cost (notoriously HMOs) only want it cheap. The shift to HMOs in
the United States is a good example of a great shift of power from
providers to insurers, who now largely control access to health
professionals. Other models to finance healthcare through public and
private providers are in place in other countries. One covers all or
most citizens through mandated employer and employee payments to
insurance or sickness fund, another relies mainly on tax revenues and
public provision. The cost of poor quality needs to be factored into
monetary incentives.
In developing a position on improving health care quality, the
utility of quality improvements and cost of quality deficiencies must
be on the agenda. If we accept that the Taguchi quality loss function
is valid, then cost must be an element in quality improvement
decisions. While many clinicians acting as agent of their patients
still argue for technical quality at any cost, other stakeholders today
have more realistic and balanced views. In evaluating quality
improvements as a reduction of poor quality performance, resources
often are redistributed with no increase in total cost for improvements
achieved. Quality is free to that point,\55\ somewhere beyond which the
Taguchi loss function recognizes an optimal point where the next unit
of improvement will no longer cost less but start to increase the cost
of the unit of care being provided, a point where costs, benefits, and
cost-effectiveness must be considered by all stakeholders. To
economists, ``costs'' means opportunity costs, the value of the lost
opportunities to do something else. Insurance payments and victim
compensation payments, while important to those who pay or receive
them, are actually transfer payments, not costs; they do not affect
society's overall resource use, just its distribution. The major
opportunity costs of adverse events in health services relate to lost
enjoyment of life of victims and their families, as well as waste in
healthcare resources and time by duplication of effort, and ad hoc
attempts to correct poor quality processes. In health services as in
any other organization, organizational waste may represents at least
20% and up to 40-50% of the total costs.\12\ Recent breakthrough
strategic methods like Six-Sigma, which tries to enhance the
predictability of positive outcomes, seem to prove that reducing rate
of defects (adverse events and errors) to roughly 3.4 per million
opportunities (nearly error-free, 99.99966% perfect, performance) is
possible in industrial applications and deserves further consideration
in health service applications. After a Six-Sigma program was
implemented, one organization's radiology cost per procedure decreased
from $68.13 to $49.\56\ As a guiding framework for producing new
evidence, we might consider another health economics tool: the
Technology Assessment Iterative Loop, an iterative process with
literature review informing research design, and evaluation results
informing future literature review, in a continuing cycle of improving
information and methods.\57\
INFORMATICS IMPLICATIONS
Organizations of businesses that contract for health care services,
notably the LeapFrog Group (http://www.leapfroggroup.org), have
admonished health care to speed up introduction of information
technology. The VA system, among others, has been perfecting paperless
medical records for several years and some hospitals are completely
paperless. Some have even developed rule-based artificial intelligence
to identify potential problems when early prevention or intervention
still is possible. Bar code medication administration systems have been
introduced in recent years. These systems can be extremely
helpful,\58\<SUP>,</SUP>\59\ but if there is poor planning new problems
do arise and staff may circumvent cumbersome processes. Even if all
stakeholders are involved from the beginning, new challenges arise.
Complex computer systems can introduce as many problems as they solve
if effective quality safeguards are missed.\60\ Automation cannot be
ignored as part of the solution, but is not a panacea.
v. recommendations
1. Proven quality management methods should be implemented in all
healthcare delivery settings.
2. We encourage applied research in order to understand what needs
to be measured to define health care quality, then develop appropriate
measurement parameters. Patient-Oriented Evidence that Matters, to
borrow a phrase from the evidence-based health movement, should be
collected and evaluated in individual facilities and network
initiatives among them.
3. These initiatives should promote the integration of
epidemiologic methods and industrial tools of quality in healthcare
institutions. Epidemiologic principles should guide collection of data
on adverse events and system failures that could cause adverse
outcomes, as well as root cause analysis to determine whether error or
other factors explains these events. Continuous quality improvement as
well as technology assessment principles should guide development of
appropriate interventions.
4. Healthcare institutions should go beyond typical health care
methodology and ``steal shamelessly and implement profusely'' the
things that work in other industries where accidents and errors have
been reduced.
5. Expert working groups should determine applicability of proposed
or best practice (``benchmark standard'') methods to the international
healthcare community, considering both developed and developing
countries.
6. Interdisciplinary working groups should consider how we can
expect health services providers to honestly report errors and near
misses without fear of having to defend themselves against legal or
administrative retribution.
7. Special interest groups, such as this one, should be used as an
efficient means of communicating requests for proposals, grant
opportunities, and of forming liaisons.
8. We should preserve traditional relationships, such as CDC with
the healthcare epidemiology and infection control community, and
develop new collaborative initiatives from current, successful
activities.
9. Within a five year period from the publication of this document,
health services organizations should set in motion quality management
systems based upon the IWA-1 QUALITY MANAGEMENT SYSTEMS--Guidelines for
process improvement in health service organizations, based on ISO
9004:2000 Second edition 2000-12-15 Quality management systems
``Guidelines for performance improvements.
With the development of the ISO 9004:2000 quality management
systems for all health services and systems, the various funding
agencies, insurers and or service users will have a consistent quality
standard to depend upon. For Federal funding agencies in the United
States or Canada, they could follow the ISO Audit principals to
guarantee performance and the customers (i.e. Company sponsored health
plans will be sure that this major supplier meets the minimum world
quality ISO guidelines).
Adverse event and error reporting system would become the province
of the organization using its internal Audit process for Non-
conformities and customer required ``corrective action'' which will
lead to preventive actions. External compliance will be possible using
the ISO registration system for those health systems which choose to
become ISO registered, or for those using the different current
approaches for accreditation or the JCAHO, NCQA or URAC delegated
reviews. The reviews are a method for state governments and the federal
governments in the United States and Canada to use non-government
organizations to review the service providers to whom they make
payments. We propose that the ISO Registrars serve the same purpose as
is currently provided by JCAHO, NCQA or URAC should a health service
organization decide to become ISO registered.
ACKNOWLEDGEMENTS:
Members of the special interest group at the time this position
paper was ratified are: Brazil: Mariangela Cavalcante, MD, MPH; Cresio
Pereira, MD, MSc. Canada: Brian Addison, RN, CQA; David Birnbaum, PhD,
MPH; Joanne Langley, MD, MSc, FRCPC; Shirley Paton, MN, RN; Virginia
Roth, MD, FRCPC; Sam Sheps, MD, MSc; Geoffrey Taylor, MD, FRCPC;
Rebecca Warburton, PhD. Germany: Michael Kramer, MD, MPH. Greece: Dr
Harry Angelopulos. Italy: David Paterson, MD. Japan: Nahoko Shindo, MD,
PhD. Spain: Angel Asensio, MD, PhD; Maxima Lizan, MD, PhD, Ulises Ruiz,
MD, PhD, FACS; Toni Trilla, MD, MSc. United Kingdom: Barry Cookson,
MRCP, FRCPath. United States: Mel Alexander; Elias Anaissie, MD; Jean
Barry-Walker, PhD, RN; Murray Batt, MD; Ron Berglund, MPH; Robert
Burney, MD; Mickey Christensen, P.E; Bill Crede, MD; Richard Dixon, MD,
FACP; Mark Eckman, MD; Jeffrey Engel, MD; Marvin Fojtasek, MD; Nelson
Gantz, MD; Don Graham, MD; Peter Gross, MD; Tracy Gustafson, MD; Jim
Hinderlang; Amy Beth Kressel, MD; Steve Kritchevsky, PhD; Tammy
Lundstrom, MD; R. Michael Massanari, MD; MS; Glen Mayhall, MD; Howard
Nadworny, MD; Dan Nafziger, MD, MS; Mary Nettleman, MD, MS; Gary
Noskin, MD; Gary Preston, PhD; Salah Qutaishat, PhD, CIC; Tom Reiley,
MD; Jon Rosenberg, MD; Thomas Rushton, MD; Charles Salemi, MD, MPH; Ken
Sands MD MPH; Marisel Segarra-Newnham, PharmD, BCPS; David Simmons,
ScD, PE, CCE, CQE; Kathleen Stillwell, RN, MPA, HSA; Bernadette
Sullivan, MBA, CIC; Alan Tice, MD; Allison Weinmann, MBBS; Todd Wiblin,
MD, MS; Lynda Winterberg RN, MBA, CPHQ.
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Prepared Statement of Jonathan Harding, Medical Director, Fallon Clinic
My name is Jonathan Harding and I am the Medical Director of the
Fallon Clinic, based in Worcester, Massachusetts. Fallon Clinic, a
multi-specialty medical group practice, is part of the Fallon
Healthcare System, which also includes Fallon Community Health Plan and
the Fallon Foundation. The health plan is closely integrated with the
medical group, as was the case with many of the first managed care
plans in the country, and we believe that adherence to this model is
one reason why Fallon has been recognized over the years as a leader in
health care quality and patient satisfaction. We would like to commend
the House Energy and Commerce Committee for holding this hearing,
``Reducing Medical Errors: A Review of Innovative Strategies to Improve
Patient Safety.''
We are committed to providing quality health care to our patients,
and we demonstrate this commitment daily. Below are some examples of
the initiatives Fallon Clinic has implemented over the past couple of
years to enhance patient safety. Unless otherwise noted, all existing
projects were funded out of Fallon Clinic operations. There is much
more we can do. We know what to do. We know how to do it. We only
require resources--in programming, measurement, information technology
systems, and/or personnel at many levels--to implement additional
programs.
1. Adverse drug events recurrence prevention: Once an adverse
reaction to a drug, in hospital, nursing home, or from an ambulatory
prescription, is identified and reported, the patient should not be
inadvertently re-challenged with the same agent. At Fallon Clinic, we
trained our physicians, nurses, and others to report any adverse drug
event, through a paper reporting process, e-mail, a reporting form on
our intranet, an adverse event hotline, and other means. We identified
over 500 adverse events in a year, which a clinical pharmacist
reviewed. Notations were made in the paper chart, the electronic chart,
and in the pharmacy dispensing profile for each patient, so that
physicians of any specialty would not prescribe that drug again, and
pharmacists would not dispense the drug again to that patient even if
prescribed.
This project continues, and we seek to expand it to increase
identification of adverse events. While our physicians, case management
nurses, and nurse practitioners who detect these events in hospitals
and nursing homes are encouraged to report these events, we currently
do not get reporting of the events directly from facilities, nor does
our prior adverse event information get transmitted to the hospitals
where our patients are subsequently hospitalized, and we would like to
work to develop those links.
We also have experimented with computerized algorithms which detect
potential adverse drug events from pharmacy, laboratory, outpatient
medical visit, and inpatient claims data, and flag them for pharmacist
review. The key is to only flag prescriptions with a high yield of true
adverse events. We would like to expand this study, and further refine
and implement these algorithms, to detect and prevent more adverse drug
events. We would also like to create linkages to laboratory data to
capture even more information, create even more sophisticated
algorithms, and detect yet more ADEs. We are allocating $12,000 from
two prior awards for our ADE program to create a laboratory result
database, but then must find funding to create, test, and implement the
algorithms.
2. Adverse drug events prevention: Our adverse drug event
prevention system also allowed us to create a database of adverse
events, by drug and by type of event. That database identified specific
problematic drugs, and we have chartered teams of clinicians to develop
programs to prevent such events. Warfarin was the drug with the most
adverse events, mostly bleeding. We developed Warfarin prescribing and
monitoring guidelines, and trained special Warfarin nurses on
implementing these guidelines in the monitoring of patients on this
drug. We developed an intranet-based patient dose/test result tracking
system so that these nurses can enter their data on each patient on the
drug, and so that information is available to the primary care
physicians and specialists who treat each patient, at whatever site the
patient is seen.
The second most common cause of adverse drug events was diuretic
induced electrolyte abnormalities. We would like to implement programs
to reduce these errors simultaneously with our efforts to reduce
Warfarin errors.
3. Concurrent drug administration errors prevention: Our pharmacy
network (owned by the medical group) implemented a program of computer
screening and flagging of potential duplicate, interacting,
contraindicated, or poly-pharmacy prescribing before dispensing.
Physicians and pharmacists worked together to develop rules and our
Information Services department developed the programs to implement the
rules. As a result, before a drug is dispensed to a patient, a
pharmacist may get a warning of a potential adverse effect from the
drug. The pharmacist can then contact the prescriber to ensure that the
prescriber was aware of that potential problem, and to jointly develop
an alternative treatment plan if such is warranted.
For several drugs that are often malprescribed, we require prior
authorization. This ensures we can enforce drug prescribing guidelines
concurrently.
4. We have retrospective prescribing error prevention programs. For
example, we notify physicians who have prescribed drugs that are
relatively contraindicated in certain age groups, especially pediatric
and geriatric, of that potential drug-age interaction and ask them to
reassess them. We perform drug use review, comparing prescribing
practices to drug prescribing guidelines and identifying variations. We
could do more. We would like to increase the number of drug use
reviews. And, we could detect patients on drugs that require laboratory
or visit monitoring but for which we have no claim for such monitoring,
and notifying physicians of this lapse, before complications ensue.
5. We have prospective prescribing error prevention programs. These
include development and dissemination of drug prescribing guidelines,
notification to physicians of drug recalls, new literature about
specific drugs, warnings about common drug interactions or toxicities,
and other education about appropriate prescribing. We maintain a
telephonic drug information service to provide prescribers a real-time
consultation about the best drug therapy given a patient's specific
situation.
We would like to institute clinical pharmacist review of the drug
profile of new patients to the practice; a brown bag program to
identify patients who do not understand their drug regimen; review of
the prescriptions of patients who do not fill called-in prescriptions
(pharmacist return-to-stock lists) to detect dangerous patient non-
compliance; and other programs to ensure patients take the drugs that
they need for optimum health.
6. Maldispensing Error Prevention: In a small percentage of
dispensed drug prescriptions, a patient, a pharmacist, a nurse, or a
physician detects an error in the prescription. Perhaps the wrong drug
was dispensed to a patient, or a wrong dose or form of the correct drug
was given to the patient. In some cases, the wrong instructions were
written on the prescription. This occurs for a variety of reasons,
including translation errors (if the pharmacist misreads a doctor's
handwriting), human error, switched bottles between two patients
arriving at the pharmacy at the same time, and for a variety of other
causes.
Our pharmacy system monitors and reports dispensing errors by
category and site, and feeds this information back to prescribers and
dispensers. This allows changes in processes to reduce such errors.
Examples of such changes include: giving feedback to physicians about
handwriting; encouraging pharmacists to confirm prescriptions verbally
in the event of any doubt, confirming the patient's diagnosis to ensure
the prescription is appropriate for the patient, reinforcing the need
to confirm the patient's identity, changing the location of look-alike
and sound-alike drugs to avoid mal-dispensing, and a variety of other
interventions.
Tracking such errors also allows us to benchmark our dispensing
performance of sites against each other, and against similar
information from other organizations, when available.
7. Chemotherapy administration safety: Chemotherapy drugs have a
narrow therapeutic index. Accurate dosing is critical. Dosing is often
based on new and experimental treatment protocols, so that physician
and nursing staff are not familiar with the doses. And dosing is often
complex, based on weight, body mass index, or other patient specific
variables. We established processes to ensure patients get the correct
dose dispensed by pharmacy and administered by nursing. This project
involves use of specific forms, procedures to double check orders
before and after drug mixing, education of pharmacists and nursing
staff and medical staff.
8. Reducing ``lost to follow-up'' Current clinical guidelines
recommend that patients at high risk of cancer recurrence get specified
screening at specified, multiyear intervals. We developed cancer risk
registries to track required monitoring of patients who need secondary
screening studies, including colonoscopy, PSA, follow-up PAP smears,
mammography, chest x ray or CT scan have the recommended test done in
the required time interval. If not, reminders are sent to the patients'
primary care physicians reminding them of the needed screening test.
The Clinic has expended several hundred thousand dollars to this
effort over the past two years. With additional funding, we could
expand this program to more diagnoses. We could add additional cancer
types in which screening for recurrence with specified tests at
specified intervals is recommended. Also, we would like to enter
patients with identified small abdominal aortic aneurysms into our
registry to ensure they have regular follow-up as indicated by
guidelines for care.
The Fallon Clinic maintains a retrospective Quality Assurance
program to identify, track to resolution, and trend for prioritization
and systemic action, episodes of low quality. We maintain an atmosphere
of openness to admitting errors, in order to learn of as many such
episodes as possible. When the issues are identified, interdepartmental
or intradepartmental teams of staff develop systems to prevent the
episodes from recurring. This program is expensive to maintain, but is
necessary to detect and fix errors that could potentially affect
patient safety.
9. The Fallon Clinic maintains a Peer Review program, which, on the
basis of peer judgments, determines if standards of care have been met
in specific cases. When appropriate, corrective actions are taken--
focused on the individual or on the systems of care--to prevent
recurrence of any breaches in the standard of care. Our systems to
assess prior care are overwhelmed by the volume of cases reviewed. We
could widen our net of potential referral sources and expand the degree
of scrutiny with more resources. We already expend clerical, nursing,
and physician resources to review hundreds of cases each year.
10. The Fallon Clinic also maintains a prospective quality
assurance program. We select important aspects of clinical care for
many departments, design or adopt measurements of these aspects of
care, and measure our performance against goals, benchmarks, or
expectations. If we do not meet our own goals, we take actions--system
redesign, education, reminders, or others--to improve our performance.
JCAHO mandates such programs for Hospitals, and NCQA-accredited HMOs
must have such programs, but these requirements do not apply to
physician practices. Our state Department of Public Health does mandate
a Patient Care Assessment program, but our quality improvement
activities go beyond the requirements of the regulations.
11. Specialty Clinics: patients with diseases that are complex and
require the involvement of physicians in multiple specialties often
must make multiple appointments, receive conflicting advice, or may get
referred back and forth between specialists. Even when these obstacles
are avoided, a sequence of multiple consultations takes time and may
delay appropriate treatment to the detriment of the patient.
The Fallon Clinic has developed multi-specialty clinics for
treatment of breast cancer (oncology, surgery, radiation therapy,
social services), diabetes (endocrinology, podiatry, diabetic
educators), and incontinence (gynecology, urology, and physical
therapy). We have plans for several other such clinics--for peripheral
vascular disease, infertility, breast cancer diagnosis, chronic pain,
and other conditions. We believe that after an initial investment of
management and physician time, and marketing, these multidisciplinary
clinics will be self-sustaining. The only limitation to the development
of such clinics is the start-up investment of management and staff
time.
We would also like to develop an intranet based obstetrical
registry to ensure that physicians and midwives have access to clinical
assessment and laboratory data on patients at any site they are seen,
including outpatient offices and the Labor and Delivery suite. This
will ensure that clinical information is available when patients
present with pre-term labor, even when offices are closed. It will also
allow us to correlate obstetrical outcomes with pre-natal care
processes. While Fallon Clinic has historically had low prematurity and
low birth weight rates compared to national averages, this registry may
allow us to improve further upon this record.
There are many, many ideas in the marketplace of patient safety
initiatives; ideas are not the rate-limiting step in implementing
medical error reduction. What we need is a commitment to reducing the
incidence rate of medical errors and the resources to make patient
safety a reality. At Fallon, I believe we have a high level of such
commitment. We also devote a steadily increasing amount of resources to
safety programs, and are fortunate to be able to count on some project
aid in addition to our own outlays in order to fund them. However, we
are limited--as are the rest of the provider community and the health
plans--by the economics of health care delivery these days: too few
reimbursement dollars for an ever-increasing level of demand. We look
forward to a solution to this resource constraint in the form of a
policy commitment at the national level to help the medical community
reduce medical errors. With that support we can put in place the
measures that we know will save lives. I want to thank the members of
the committee for putting this matter on the national agenda.
______
Prepared Statement of Premier, Inc.
Premier, Inc., a strategic alliance of leading not-for-profit
hospitals and health systems nationwide, appreciates the opportunity to
share our perspectives on healthcare quality, patient safety, and
adverse medical events. There are, perhaps, no issues of greater
significance in the healthcare arena today than the sustained
improvement of care quality and the reduction of systemic error. We
thank Health Subcommittee Chairman Mike Bilirakis (R-FL) and Ranking
Member Sherrod Brown (D-OH) for holding today's hearing.
The 1999 Institute of Medicine report, To Err is Human, and its
2001 sequel, Crossing the Quality Chasm, engendered a maelstrom of
public attention on medical errors and patient safety. Initially,
public policy debate coalesced around the controversial notion of
mandatory versus voluntary reporting of medical errors and adverse drug
events (ADEs). Subsequent discussion was diverted from rhetorical,
litigious finger-pointing and individual blame in favor of more pointed
analysis of systemic shortcomings and cultural reform.
Premier strongly believes that caregivers ought to be encouraged to
share medical error and patient safety information without reprisal in
a voluntary, non-punitive environment. In the drive for sustained
medical error reduction, the importance of education and lessons
learned cannot be overstated.
Premier hospitals have long prioritized patient safety and the
pursuit of sustained quality improvement in the delivery of care. The
IOM reports, and subsequent accounts by other independent
organizations, validate our core belief that quality improvement in the
health delivery system can be achieved and sustained when multi-tiered,
systemic approaches are employed in support of an open environment that
replaces a culture of blame with that of safety, education,
information-sharing and the pursuit of technological and clinical
innovation.
Support for a non-punitive reporting environment that prioritizes
prevention and the correction of systemic shortcomings ought to serve
as the launch pad for any congressional action. Premier believes that a
comprehensive confidential reporting system--one that does not focus on
individual culpability or organizational blame--would effectively
facilitate the sharing of safety and error-related information among
health organizations, and foster collaboration with other providers.
Premier and its member health systems have developed and continue
to expand upon comparative databases of clinical, financial, and
operational metrics at the provider level. Such databases allow
hospitals to compare their performance against that of peer
institutions, and to determine areas ripe for measurable improvement.
In collaboration with the Institute for Healthcare Improvement (IHI),
we have launched clinical performance initiatives (CPIs) in such key
areas as medication management and adverse drug event (ADE) prevention,
and stroke, community-acquired pneumonia, cardiac (coronary artery
bypass) care. Armed with comparative data supporting evidence-based
evaluation of processes and practices, health systems working together
can delve deeper, further and faster into the realm of safer, higher
quality healthcare than they ever could alone. As the 1999 IOM report
concluded, the core problem in healthcare service delivery is most
certainly not a lack of effort or conviction on the part of the
individuals within those settings. Rather, investigators argued, the
systems necessary to foster and facilitate improvement must be
developed. Premier's healthcare informatics databases were built with
this notion in mind. (As addenda to this statement, please find the
commentary of Premier President and CEO Richard Norling, published in
the Feb. 18, 2002 Modern Healthcare, and a fact sheet outlining
Premier's activities in the sharps safety arena. Both documents offer
additional insight into our philosophy of healthcare quality and safety
improvement, and detail the initiatives and programs through which we
put our philosophy into living, breathing practice.)
The Premier Safety Institute, an alliance-wide initiative,
integrates the safety-related activities of members, service units,
business partners, and communities. These include the identification of
safety-focused products, equipment, and services; the provision of
training, educational resources, and clinical and technical
information; and the fostering of opportunities for networking and
collaboration. Premier's on-going medication CPI, for example,
integrates new and existing projects to improve patient outcomes by
measurably reducing ADEs and supporting drug utilization improvements.
The aim of this patient safety collaborative is to reduce the average
number of preventable ADEs at participating hospitals by 50 percent by
June 2004.
This week, the Safety Institute reported on the results of two six-
month field evaluations of safety-equipped syringes and phlebotomy
(blood-drawing) devices to better assess clinical efficacy and
practitioner preference. The studies were designed to identify safety
device performance considerations that would contribute to innovative
product design, as well as gain member clinician input for Premier's
contracting process. Premier currently leads the industry in offering
its hospitals access to sharps safety devices from 15 contracted
business partners. The landmark 2000 needlestick safety and prevention
legislation, upon whose crafting Premier offered guidance and support,
stands as a critical tool in the effort to protect caregivers from
injurious needlesticks and blood-borne infections, like HIV and
Hepatitis C.
Premier is also a passionate champion of industry adoption of the
Universal Product Number (UPN) and accompanying bar code technology for
the standard identification and tracking of hospital-administered
drugs, biologicals and devices. We believe Congress ought to facilitate
such implementation as yet another innovative strategy for improving
patient safety.
HHS Secretary Tommy Thompson echoed this sentiment last November at
a hearing before the full Energy and Commerce Committee on bioterrorism
preparedness:
I have said on several occasions that bar-coding technology has
mass potential for safeguarding against medical mistakes. Since
September 11, we are all the more aware of how critical it is
to shore-up and expedite the healthcare supply chain and
delivery function--so we can save more lives, especially in
times of crises.
Numerous public and private organizations have engaged in
campaigns, programs, and initiatives to foster the desired changes
outlined here. The National Quality Forum (NQF), of which Premier is a
member, is a public-private partnership charged with developing and
implementing a national strategy for healthcare quality measurement and
reporting. One current NQF project is aimed at generating consensus on
a core set of patient safety measurements, with respect to avoidable
adverse events in hospital care. The core measure set will enable
standardized data collection and event reporting within and across
states. The wealth of knowledge and clinical information to be mined
from Premier's informatics databases can prove instrumental in this and
similar efforts.
The Department of Health and Human Services' Agency for Health Care
Research and Quality (AHRQ), with which Premier collaborates, supports
medical error reporting demonstration projects, and the deployment of
new and emerging information and patient safety technologies for the
reduction of adverse events. Premier was gratified to learn that this
year, AHRQ plans to zero-in on patient safety; quality and disparity
reporting, the translation of research into clinical practice, and
consumer education. We support full agency funding for these
priorities.
Again, we appreciate this opportunity to provide a statement for
the record on issues of such paramount importance as patient safety and
care quality.
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