[House Hearing, 107 Congress]
[From the U.S. Government Publishing Office]



 
 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.1 An American Association for Retired 
Persons survey showed that 58 per cent of the elderly population makes 
errors when taking their medications.2 Nearly 10 per cent of 
all Medicare hospital admissions are reported to be the result of 
medication non-compliance.3 Furthermore, it has been 
estimated that the annual economic cost of non-compliance exceeds $100 
billion per year.4
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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 
1:14.5 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.6 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:

 Patients taking incorrect doses
 Patients taking medication at the wrong time
 Patients forgetting one or more doses
 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.7 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.8
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.9 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.
---------------------------------------------------------------------------
    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:
     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.
     A litigious health care environment is not conducive to 
        the promotion of awareness and information sharing necessary to 
        understand and avoid medical errors.
     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 TM 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 1, 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:

 Speak up if you have questions or concerns.
 Pay attention to the care you are receiving. Make sure you are 
        receiving the right treatment. Don't assume anything.
 Educate yourself about your diagnosis and the medical tests 
        you are undergoing and your treatment plan.
 Ask a trusted family member or friend to be your advocate if 
        you can not advocate for yourself.
 Know what medications you take and why you take them.
 Use a hospital, clinic, surgery center or other type of health 
        care organization that has undergone rigorous on-site 
        evaluation.
 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.

 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.
 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.
 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 SM, 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:

 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.
 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.
 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.
 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.
 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.

 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.''
 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.
 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.
 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.
 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):

 Veterans Administration Adverse Drug Event Working Group 
        Project
 Veterans Administration Work Group on Nomenclature and 
        Taxonomy for Creating a Medication Error Reporting System
 JCAHO Expert Panel on Medication Safety
 Pittsburgh Regional Healthcare Initiative, AHRQ Grant Advisor 
        on Improving Patient Safety: Health Systems Reporting, 
        Analysis, and Safety Improvement Research Demonstrations
 National Quality Forum Safe Practices Steering Committee, Vice 
        Chair of Technical Advisory Panel to the NQF Committee
 Health Research and Education Trust of the AHA, Commonwealth 
        Grant Advisor on Reducing Medication Errors, Pathways for 
        Medication Safety.
 University of North Carolina, AHRQ Grant for Centers for 
        Education and Research on Therapeutics--Reporting Adverse Drug 
        Events in Infants, Children, and Adolescents
 American Academy of Family Physicians, AHRQ Grant Advisor on 
        Developing Center for Education and Research on Patient Safety 
        in Primary Care
 University of Pennsylvania, AHRQ Grant Advisor on Developing 
        Innovative Approaches to Improving Patient Safety
 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.
 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.
 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.
 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.
 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.
 The causes of errors and their solutions must be widely shared 
        so that all healthcare organizations can learn from the 
        experiences of others.
 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:

 34% more patients getting medications to prevent a second 
        heart attack;
 23% more stroke patients receiving drugs that prevent 
        subsequent strokes;
 12% more heart failure patients getting treatment needed to 
        extend their active lives;
 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 TM (NGC TM)--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.
 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.
 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.
 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.
 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.
 The causes of errors and their solutions must be widely shared 
        so that all healthcare organizations can learn from the 
        experiences of others.
 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\,\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\,\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:

 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.
 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.
 There should be encouragement for the development of voluntary 
        reporting efforts including the review and coordination of 
        sponsors and users of external reporting systems.
 Peer review protection for data related to patient safety and 
        quality improvement should be expanded.
 Performance standards and expectations for health 
        professionals should focus greater attention on patient safety.
 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.
 Health care organizations and professionals should, make 
        continually improving patient safety programs a declared and 
        serious aim that includes defined executive responsibility.
 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\,\6\,\7\,\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\,\16\,\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\,\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\,\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\,\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\,\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\,\53\,\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\,\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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