    [House Hearing, 109 Congress]
    [From the U.S. Government Publishing Office]

                                  PUBLIC REPORTING OF
                             HOSPITAL-ACQUIRED INFECTION
                                  RATES:  EMPOWERING
                               CONSUMERS, SAVING LIVES
    ============================================================================

                                      HEARING

                                     BEFORE THE

                            SUBCOMMITTEE ON OVERSIGHT AND
                                   INVESTIGATIONS

                                       OF THE

                              COMMITTEE ON ENERGY AND
                                      COMMERCE

                             HOUSE OF REPRESENTATIVES

                            one hundred ninth congress
                                  second session

                                      -------

                                  March 29, 2006

                                Serial No. 109-85

                                      -------

                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
                          JOE BARTON, Texas, Chairman
    RALPH M. HALL, Texas                      JOHN D. DINGELL, Michigan
    MICHAEL BILIRAKIS, Florida                  Ranking Member
      Vice Chairman                           HENRY A. WAXMAN, California
    FRED UPTON, Michigan                      EDWARD J. MARKEY, Massachusetts
    CLIFF STEARNS, Florida                    RICK BOUCHER, Virginia
    PAUL E. GILLMOR, Ohio                     EDOLPHUS TOWNS, New York
    NATHAN DEAL, Georgia                      FRANK PALLONE, JR., New Jersey
    ED WHITFIELD, Kentucky                    SHERROD BROWN, Ohio
    CHARLIE NORWOOD, Georgia                  BART GORDON, Tennessee
    BARBARA CUBIN, Wyoming                    BOBBY L. RUSH, Illinois
    JOHN SHIMKUS, Illinois                    ANNA G. ESHOO, California
    HEATHER WILSON, New Mexico                BART STUPAK, Michigan
    JOHN B. SHADEGG, Arizona                  ELIOT L. ENGEL, New York
    CHARLES W. "CHIP" PICKERING,  Mississippi ALBERT R. WYNN, Maryland
      Vice Chairman                           GENE GREEN, Texas
    VITO FOSSELLA, New York                   TED STRICKLAND, Ohio
    ROY BLUNT, Missouri                       DIANA DEGETTE, Colorado
    STEVE BUYER, Indiana                      LOIS CAPPS, California
    GEORGE RADANOVICH, California             MIKE DOYLE, Pennsylvania
    CHARLES F. BASS, New Hampshire            TOM ALLEN, Maine
    JOSEPH R. PITTS, Pennsylvania             JIM DAVIS, Florida
    MARY BONO, California                     JAN SCHAKOWSKY, Illinois
    GREG WALDEN, Oregon                       HILDA L. SOLIS, California
    LEE TERRY, Nebraska                       CHARLES A. GONZALEZ, Texas
    MIKE FERGUSON, New Jersey                 JAY INSLEE, Washington
    MIKE ROGERS, Michigan                     TAMMY BALDWIN, Wisconsin
    C.L. "BUTCH" OTTER, Idaho                 MIKE ROSS, Arkansas
    SUE MYRICK, North Carolina
    JOHN SULLIVAN, Oklahoma
    TIM MURPHY, Pennsylvania
    MICHAEL C. BURGESS, Texas
    MARSHA BLACKBURN, Tennessee

                           BUD ALBRIGHT, Staff Director
                          DAVID CAVICKE, General Counsel
          REID P. F. STUNTZ, Minority Staff Director and Chief Counsel
                                      -------

                   SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
                         ED WHITFIELD, Kentucky, Chairman
    CLIFF STEARNS, Florida                    BART STUPAK, Michigan
    CHARLES W. "CHIP" PICKERING,  Mississippi   Ranking Member
    CHARLES F. BASS, New Hampshire            DIANA DEGETTE, Colorado
    GREG WALDEN, Oregon                       JAN SCHAKOWSKY, Illinois
    MIKE FERGUSON, New Jersey                 JAY INSLEE, Washington
    MICHAEL C. BURGESS, Texas                 TAMMY BALDWIN, Wisconsin
    MARSHA BLACKBURN, Tennessee               HENRY A. WAXMAN, California
    JOE BARTON, Texas                         JOHN D. DINGELL, Michigan
      (EX OFFICIO)                              (EX OFFICIO)

                                    CONTENTS

                                                                           Page
    Testimony of:

    Wagner, Jr., Raymond T., Legal and Legislative Vice President,
     Enterprise Rent-a-Car                                                   17
    Cardo, Dr. Denise, Chief, Division of Healthcare Quality Promotion,
     Centers for Disease Control and Prevention, U.S. Department of Health
     and Human Services	                                                 39
    Goeschel, Chris, Executive Director, MHA Keystone Center for Patient
     Safety and Quality	                                                229
    Haley, Dr. Robert Ware, Division of Epidemiology, Southwestern Medical
     School, University of Texas Southwestern Medical Center	        237
    Volavka, Marc, Executive Director, Pennsylvania Health Care Cost
     Containment Council	                                                242
    Shannon, Dr. Richard P., Chair, Department of Medicine, Allegheny
     General Hospital                                                       253
    Hammer, Dr. Scott, Chief, Division of Infectious Diseases, New York
     Presbyterian Hospital/Columbia University Medical Center	        262
    Hanrahan, Dr. Jennifer A., Chairperson, Infection Control Committee,
     HetroHealth Medical Center	                                        268
    Daley, Dr. Jennifer, Senior Vice President and Chief Medical Officer,
     Tenet Healthcare Corp.	                                                274
    Additional material submitted for the record:

    Volavka, Marc, Executive Director, Pennsylvania Health Care Cost
     Containment Council, response for the record	                        287
    Cardo, Dr. Denise, Chief, Division of Healthcare Quality Promotion,
     Centers for Disease Control and Prevention, U.S. Department of Health
     and Human Services, response for the record	                        292
    Haley, Dr. Robert Ware Haley, Division of Epidemiology, Southwestern
     Medical School, University of Texas Southwestern Medical Center,
     response for the record	                                        298
    Wagner, Jr., Raymond T., Legal and Legislative Vice President,
     Enterprise Rent-a-Car, response for the record	                        303

                                PUBLIC REPORTING OF
                            HOSPITAL-ACQUIRED INFECTION
                           RATES:  EMPOWERING CONSUMERS,
                                   SAVING LIVES

                                     -------
                             WEDNESDAY, MARCH 29, 2006

                            HOUSE OF REPRESENTATIVES,
                        COMMITTEE ON ENERGY AND COMMERCE,
                 SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS,
                                                                 Washington, DC.

    The subcommittee met, pursuant to notice, at 2:00 p.m., in Room
    2322 of the Rayburn House Office Building, Hon. Ed Whitfield
    (chairman) presiding.
    	Members present:  Representatives Ferguson, Burgess, Barton (ex
    officio), Stupak, DeGette, Inslee, Murphy, and Whitfield.
    	Staff present:  Andrew Snowdon, Counsel; Mark Paoletta, Chief
    Counsel for Oversight and Investigations; Mike Abraham, Legislative
    Clerk; Edith Holleman, Minority Counsel; and Elizabeth Ertel, Minority
    Professional Staff Member.
            MR. WHITFIELD.  Good afternoon, and I am going to call this hearing
    to order.
    	As you know, the title of today's hearing is "Public Reporting of
    Hospital-Acquired Infections Rates: Empowering Consumers and Saving
    Lives."  Hospital-acquired infections are a significant, yet largely
    unnoticed public health crisis in our country.  The costs of hospital-
    acquired infections are staggering, not just in financial terms, but also in
    terms of human suffering.  Every year, nearly two million people pick up
    infections in hospitals, and 90,000 of them die from those infections,
    more than die from breast cancer or automobile accidents.
    	Numbers that large are almost incomprehensible and they often
    become just another statistic, but as we will hear from our first witness,
    Mr. Raymond Wagner, each and every hospital-acquired infection
    represents a real human being, and I hope that fact will remain front and
    center as we discuss this important and complex issue.
    	The question, then, isn't whether something needs to be done about
    hospital infections, but what should be done?  Today's hearing will
    examine one approach to this oppressing problem.  Many States have
    recently passed laws requiring public reporting of hospital infection
    rates, believing that public accountability will drive change.  To date, 6
    States have passed public reporting laws, and some 20 to 30 others have
    legislation pending.
    	The public reporting train has left the proverbial station, so
    collectively, we need to figure out how to make public reporting as
    effective and fair as possible.  A patchwork of State reporting laws
    presents both a challenge in terms of differing standards and
    requirements, but also an opportunity.  Uniform national standards might
    ultimately be appropriate, but in the meantime, these State efforts serve
    as an excellent laboratory to identify the best practices.
    	On a personal note, I feel strongly that consumers should have the
    right to know how hospitals measure up on this important issue.
    Transparency has been a fundamental theme of this committee's
    healthcare work, and hospital infections are no different.
    	To steal a line from Dr. Haley, one of the witnesses here today,
    "What gets measured, gets done."  I hope that this hearing will shine a
    spotlight on hospital-acquired infections and provide an opportunity to
    obtain diverse perspectives on how best to confront the crisis.  This is not
    a simple issue.
    	While everyone supports the concept of public reporting, the devil
    truly is in the details.  As States move forward with legislation and the
    Federal government considers its role in this arena, complexities such as
    consistency in compliance and variations among patient populations, also
    known as the "our patients are sicker" defense, will have to be addressed.
    	We certainly are not going to resolve all of these thorny issues this
    afternoon, but perhaps we can identify some common ground that will
    serve as a meaningful starting point.  Throughout this process, however,
    all parties involved, from legislators to hospitals to consumer groups to
    insurers to standard organizations, must be careful not to allow details to
    derail the ultimate goal of public reporting and transparency, reducing
    the number of hospital-acquired infections.  There are too many lives at
    stake to permit the perfect to be the enemy of the good.
    	I want to thank all of the witnesses who have agreed to participate in
    today's hearing.  As I mentioned earlier, the first witness will be Ray
    Wagner, whose teenage son got a serious staph infection after
    undergoing surgery for a broken arm.  Determined to prevent other
    families from going through the same horrible experience, Mr. Wagner
    was instrumental in the passage of Missouri's public reporting law.
    	We will also hear from the Centers for Disease Control about what
    the Federal government has done to track and report hospital infections,
    and finally, we will hear from the experts on our third panel about the
    advantages of and concerns about public reporting, as well as the
    tremendous successes that some of these people have had in reducing
    hospital-acquired infections.
    	I am especially interested in hearing from several hospital
    representatives, since they are on the very front line battling this crisis on
    a daily basis.  I look forward to a lively and informative hearing this
    afternoon, and once again, I want to thank all of the witnesses.  We know
    it takes a lot of time and effort for you to appear, but we do value your
    input.
    	[The prepared statement of Hon. Ed Whitfield follows:]

    PREPARED STATEMENT OF THE HON. ED WHITFIELD, CHAIRMAN, SUBCOMMITTEE ON
    OVERSIGHT AND INVESTIGATIONS

             Hospital-acquired infections are a significant, yet largely
    unnoticed, public health crisis in this country.  The costs of hospital-acquired infections are staggering, not just in financial terms, but also
    in terms of human suffering:  every year nearly 2 million people
    pick up infections in hospitals, and 90,000 of them die -- more than die
    from breast cancer or automobile accidents.  Numbers that large are almost
    incomprehensible, and they often become just another statistic.  But as we
    will hear from our first witness, Mr. Raymond Wagner, each and every
    hospital-acquired infection represents a real human being, and I hope that
    fact will remain front and center as we discuss this important and
    complex issue.
    	The question, then, isn't whether something needs to be done about
    hospital infections, but what.  Today's hearing will examine one approach
    to this pressing problem.  Many states have recently passed laws requiring
    public reporting of hospital infection rates, believing that public
    accountability will drive change.  To date, six states have passed public
    reporting laws, and some 20 to 30 others have legislation pending.  The
    public reporting train has left the proverbial station, so, collectively,
    we need to figure out how to make public reporting as effective and fair
    as possible.  A patchwork of state reporting laws presents both a challenge,
    in terms of differing standards and requirements, but also an opportunity.
    Uniform national standards might ultimately be appropriate, but in the
    meantime, these state efforts serve as an excellent laboratory to identify
    the best practices.
            On a personal note, I feel strongly that consumers should have the
    right to know how hospitals measure up on this important issue.
    Transparency has been a fundamental theme of this Committee's healthcare
    work, and hospital infections are no different.  To steal a line from Dr.
    Haley, one of the witnesses here today:  "What gets measured gets done."
            I hope that this hearing will shine a spotlight on hospital-
    acquired infections and provide an opportunity to get some diverse
    perspectives on how best to confront this crisis.  This is not a simple
    issue.  While almost everyone supports the concept of public reporting, the
    devil truly is in the details.  As states move forward with legislation --
    and the federal government considers its role in this arena -- complexities
    such as consistency in compliance and variations among patient populations,
    also known as the "our patients are sicker" defense, will have to be
    addressed.  We certainly aren't going to resolve all of these thorny issues
    this afternoon, but perhaps we can identify some common ground that will
    serve as a meaningful starting point.
            Throughout this process, however, all parties involved -- from
    legislatures, to hospitals, to consumer groups, to insurers, to standards
    organizations -- must be careful not to allow the details to derail the
    ultimate goal of public reporting:  reducing the number of hospital-acquired
    infections.  There are too many lives at stake to permit the perfect to be
    the enemy of the good.
            I want to thank all of the witnesses who have agreed to participate
    in today's hearing.  As I mentioned earlier, the first witness will be Ray
    Wagner, whose teenage son got a serious staff infection after undergoing
    surgery for a broken arm.  Determined to prevent other families from going
    through the same terrible experience, Mr. Wagner was instrumental in the
    passage of Missouri's public reporting law.  We will also hear from the CDC
    about what the federal government has done to track and report hospital
    infections.  Finally, we will hear from the experts on our third panel
    about the advantages of, and concerns over, public reporting, as well as
    the tremendous successes that some of these people have had in reducing
    hospital-acquired infections.  I am especially interested in hearing from
    several hospital representatives, since they are at the front line,
    battling this crisis on a daily basis.
            I look forward to a lively and informative hearing this afternoon.
    With that, I turn to Mr. Stupak, the Ranking Member of this Subcommittee,
    for his opening remarks.

            MR. WHITFIELD.  At this time, I would like to recognize Mr. Stupak,
    the Ranking Member of this subcommittee for his opening remarks.
    	MR. STUPAK.  Thank you, Mr. Chairman, and thank you for holding
    this hearing on a topic of immense importance to the American public.
    	Most of us have either been in a hospital or had family or friends
    in a hospital.  We all know that in recent years, there has been a growing
    and real sense among the public that you should get out of the hospital as
    soon as possible to avoid getting a hospital-acquired infection.
    	The Centers for Disease Control estimates that 90,000 patients die
    every year from hospital-acquired infections, and that 75 percent of them
    are preventable deaths.  Over 80 percent of these deaths each year could
    be prevented.  The human loss is tragic and unacceptable.  The economic
    loss is staggering.  In Pennsylvania alone, the additional costs of treating
    these infections is $2 billion.
    	Perceiving a lack of will from the healthcare industry, consumer
    advocates have launched legislative and public information campaigns to
    demand that hospitals clean up their acts, so to speak, and publicly report
    their infection rates.  However, reporting is only one of the many tools
    worthy of examination.  Reporting alone will not reduce infections.
    	Although CDC has been collecting data from a small group of
    hospitals for over 30 years, it has not been able to stop the epidemic of
    hospital-acquired infections.  Reducing hospital infection rates requires
    more than agreeing on definitions of what a hospital-acquired infection
    is.  It requires process changes: process changes in hospital cleanliness,
    in the insertion of central lines, in the operating rooms where surgical
    site infections occur, and in the treatment of patients on ventilators.
    More importantly, it requires commitment and enforcement at the top
    levels of hospital administration: the full cooperation of doctors, nurses,
    and surgeons; a good hospital training program; and clear action plans
    that have real results.
    	Two of our witnesses today are from Michigan, and one is from
    Pennsylvania.  They will demonstrate what can be done when hospitals
    decide to act.  Lives are saved and healthcare costs are reduced.  I am
    particularly proud of the work done by Michigan hospitals through the
    Keystone Center for Patient Safety and Quality.  Ms. Chris Goeschel is
    here today representing Michigan's efforts without public reporting and
    with very little public money.  Ms. Goeschel will also point out how
    much this country spends on developing new healthcare technologies,
    and how little this country spends on actually improving the delivery of
    healthcare.  Fortunately, many nonprofit groups are working on changing
    processes in hospitals.  Consumers Union provides a checklist for
    persons undergoing surgery to discuss with their doctors.  The Institute
    for Healthcare Improvement, sponsored by private foundations, set up a
    project with 14 hospitals that reduce ventilator associated pneumonia, a
    leading killer in hospital-acquired infections, to zero for an entire year.
    	The hospitals implemented simple procedures, such as raising the
    head of patients.  The project has now been expanded to 3,000 hospitals
    as part of their campaign to save 100,000 lives by implementing
    evidence-based preventative care for not only ventilator associated
    pneumonia, but also surgical site and central line infections.
    	At a time when our country is facing a healthcare crisis, we must act
    now.  These infections cost lives and billions of dollars in healthcare
    costs in untold amounts to the larger economy.  There is no more time
    for excuses.  Hospitals, government agencies, and legislators cannot sit
    back and allow this unacceptable trend of increased hospital infections to
    continue.  I hope this hearing will advance the discussion and shine light
    on this important consumer and health issue.
    	With that, Mr. Chairman, I yield back the balance of my time.
    	MR. WHITFIELD.  Thank you, Mr. Stupak.
    	At this time, I recognize Dr. Burgess of Texas for his five-minute
    opening statement.
    	MR. BURGESS.  Thank you, Mr. Chairman, and thank you for
    holding this hearing today.  I want to give a special welcome to two
    North Texans who were gracious enough to travel here to Washington,
    D.C. to testify with us today, Dr. Jennifer Daley and Dr. Robert Haley.
    Dr. Jennifer Daley is the Senior Vice President and the Chief Medical
    Officer at Tenet Healthcare Corporation in Dallas, while Dr. Haley is
    with the Division of Epidemiology at Southwestern Medical School and
    the University of Texas Southwestern Medical School in Dallas.  Dr.
    Haley also has the distinction of being the individual who cracked the
    code and solved the riddle of Gulf War Syndrome as being a pseudo-
    cholodestrates deficiency, and we were all very grateful for your work in
    that endeavor, Dr. Haley.  Of course, Southwestern Medical School, as
    everyone in Washington knows, is one of the premier medical
    institutions in the Nation.  I don't need to tell this committee that.  I am
    proud to have an established healthcare fellowship program in my office,
    and my healthcare fellow is with us today.  Dr. Daley and Dr. Haley,
    thank you both very much for being here and spending some time with
    us today.
    	I was Chief of Staff at Lewisville Medical Center in Lewisville,
    Texas, back in the '90s, and I understand all too well the dangers of those
    communal infections.  There are many thousands of people each year
    who suffer and in fact die because of infections they contract while
    staying in a hospital, but I also understand the difficulties involved with
    managing these situations.  In fact, I remember as in intern at Parkland
    Hospital we were not allowed to use what were called prophylactic
    antibiotics, and someone pointed out one day that our C-section infection
    rate was so high everyone got sick, so it wasn't really prophylactic
    antibiotics, it was early treatment.  Once we switched to early treatment,
    we were able to save a lot of patients serious morbidity and possibly
    even mortality.
    	As Members of Congress, it is our duty to utilize our effective
    oversight methods to ensure that the healthcare needs are adequately met
    and that patients have the tools available to them to make informed
    decisions, and this degree of transparency is something that I think we
    need to really establish.
    	But again, Mr. Chairman, I thank you for holding this hearing in
    which we can address some of these important concerns relating to
    hospital-acquired infections.  It is not an easy subject and there are not
    any absolutely right or absolutely wrong answers, but it behooves us to
    direct our time and attention to this matter.  And with that, I will yield
    back the balance of my time.
    	MR. WHITFIELD.  At this time, I recognize the gentleman from
    Washington, Mr. Inslee, for his opening statement.
    	MR. INSLEE.  Thank you.  One of the things that has really impressed
    me about this subject and others is how often using existing technology
    can be so supremely effective, you know.  I know everybody has been
    associated with a hospital and knows about all the new technology we
    have, but using existing technology can be so effective.
    	I was just reading in the Washington Post this morning about
    Allegheny General Hospital found that they had this problem with
    intravenous infections, or at least they perceived improvements could be
    made, and they standardized procedures, investigated every single
    infection in 24 hours.  They cut their annual infections from 49 to three.
    They reduced their deaths from 19 to one.  They slashed their infections
    from ventilators from 45 to eight, just by using standardized procedures
    of well-known techniques, not inventing a new gizmo or a new medical
    device, just by using what is known.  It is so impressive of the results
    that can be attained, so I hope out of this hearing we have some ways to
    help hospitals and consumers spare this, because I think consumers can
    be a pretty effective incentive for all of us to continue to improve.
    	Thanks for holding this hearing, Mr. Chairman.
    	MR. WHITFIELD.  Thank you, Mr. Inslee.  At this time, the Chairman
    of the Committee of Energy and Commerce is here, and we will
    recognize Chairman Joe Barton of Texas for his opening statement.
    	CHAIRMAN BARTON.  Thank you, Mr. Chairman, and I want to thank
    you for holding this hearing.  There is so much going on today that it is
    probably not going to get the attention it deserves, but there is no more
    important hearing in the Congress today than this one that we are about
    to undertake.
    	When people check into the hospital, they hope and expect to leave
    better off than when they checked in, but unfortunately, some of the
    people that check in pick up an infection and they are lucky to check out,
    or very unfortunately, some never do.  Hospital-acquired infections are a
    serious and growing problem, and I want to thank you for agreeing to
    hold a hearing to shine the spotlight on this problem.
    	Two weeks ago, the Health Subcommittee heard about pricing
    transparency in the health market.  During that hearing, I said that the
    term "healthcare market" is an oxymoron because the current system
    prevents consumers from making informed choices by denying them
    access to relevant information.  I want to add today that the quality of
    healthcare is at least as murky as its cost.  We don't know which
    hospitals are safe and successful anymore than we know how much they
    charge.  I believe consumers should have the right to find out just how
    well their hospitals perform.  We demand safety information when we
    buy a car or a child safety seat.  It is baffling that we would accept less
    when it comes to something as important as our health in our hospitals.
    	I hope that this is beginning to change.  A half dozen States have
    passed laws requiring hospitals to publicly report their infection rates,
    and more than 20 others, including my State of Texas, are considering
    similar legislation.  I applaud these efforts, but it seems likely that a
    patchwork of 50 different State reporting laws might confuse consumers
    and burden hospital systems operating in more than one State.  I am also
    mindful of the fact that this is not a simple issue, and I expect that we are
    going to hear this afternoon some of the concerns and complexities
    associated with public reporting.
    	I do believe, though, that transparency and public scrutiny create
    pressure to improve.  Pressure comes from a variety of sources: it comes
    from the peers in the medical community, of course, but it also comes
    from the employers, the Federal government, and private insurers who
    don't want to pay top dollar for substandard care.  To some extent, it
    comes from the individual patients like me.  Back in December I had a
    heart attack.  I was taken to the emergency here in Washington, D.C., at
    a local hospital.  I can promise you that at that time, the specific topic of
    infection rates was not at the top of my mind, but I was never more
    interested in the general topic of quality.
    	I will give an example.  The doctor here in the Capitol, when he told
    me that I was having a heart attack, he asked if I had a cardiologist.
    Well, obviously, I didn't have a cardiologist, so as we were speeding in
    the ambulance, my Chief of Staff, Bud Albright, and my personal
    assistant, Ryan Thompson, they actually got to the hospital a little bit
    before the ambulance did, which was amazing.  They go into the
    emergency room and they start asking about cardiologists.  Mr. Albright
    said "do you all recommend a cardiologist?"  And the emergency room
    doctor said "we can't recommend anybody."  And Bud said, "isn't this
    where Vice President Cheney had his heart operation?"  And the
    emergency room doctor said "yes."  Bud said "we want his doctor."  And
    that's who we got.
    	MR. BURGESS.  That's why they sedated you during your procedure,
    by the way.
    	CHAIRMAN BARTON.  So I was very interested in the quality when I
    went into the emergency room with my heart attack.
    	My presence here today at this hearing is evidence that I found a lot
    of quality in the staff at the hospital here in Washington, D.C., and in
    their practice of medicine, and I am very thankful to those people for all
    that they did for me and they have done for hundreds, if not thousands, of
    others.  I didn't really have a choice.  I had to see a doctor and I had to
    have an operation.  If I were choosing today to submit to elective
    surgery, I think I would want to know a little bit more about the hospital,
    and I would want to know a little bit more about the infection rates and
    things like that.  It seems to me that there is no better indicator of poor
    quality than hospitals which in and of themselves might make people
    sick.
    	I want to express my thanks to the witnesses for being here this
    afternoon.  I am especially anxious to hear from Dr. Haley about the
    status of the Texas reporting law.  I look forward to learning from these
    distinguished experts how we can stem the tide of hospital-acquired
    infections and make sure the consumers get the information that they
    need to make informed healthcare decisions.
    	Again, Mr. Chairman, thank you for holding this hearing.
    	[The prepared statement of Hon. Joe Barton follows:]

    PREPARED STATEMENT OF THE HON. JOE BARTON, CHAIRMAN, COMMITTEE ON ENERGY
                                    AND COMMERCE

              When people check into the hospital, they hope and expect to leave
    better off than they arrived.  But some of the millions of Americans who
    pick up infections in hospitals each year are lucky to check out, and a
    few never do.  Hospital-acquired infections are a serious and growing
    problem in this country, and I want to thank Chairman Whitfield for
    shining a spotlight on them.
              Two weeks ago, the Health Subcommittee heard about pricing
    transparency in the health care market.  During that hearing, I said that
    the term "health care market" is an oxymoron in this country because the
    current system prevents consumers from making informed choices by denying
    them access to relevant information.   I want add today that the quality of
    health care is at least as murky as its cost.  We don't know which hospitals
    are safe and successful any more than we know how much they charge.  I believe
    consumers should have the right to find out just how well their hospitals
    perform.  We demand safety information when we buy a car or child safety
    seat, so it is baffling that we would accept less when it comes to something
    as important as our health.
              I hope that this is starting to change.  A half-dozen states have
    passed laws requiring hospitals to publicly report their infection rates,
    and more than 20 others, including Texas, are considering similar legislation.
    While I applaud these efforts, it seems likely that a patchwork of 50
    different state reporting laws might confuse consumers and burden hospital
    systems operating in more than one state.  I am also mindful of the fact that
    this is not a simple issue, and I expect that we will hear this afternoon
    some of the concerns and complexities associated with public reporting.
              Having said that, I firmly believe that transparency and public
    scrutiny create pressure to improve.  This pressure comes from a variety of
    sources.  It comes from peers in the medical community, of course, but it
    also comes from large employers, the federal government, and private insurers
    who don't want to pay top dollar for substandard care.  And, to some extent,
    it comes from individual patients, like me.
               Back in December, I had a heart attack and was taken to the
    emergency room at a local hospital.  I can promise you that at that time,
    the specific topic of infection rates was not in the front of my mind, but
    I've never been more interested in the general topic of quality.   My
    presence here today is evidence that I found a lot of it in the staff and
    practices at George Washington Hospital that night.  That's good, because
    I had no choice.  If I were choosing today to submit to elective surgery,
    however, I'd want to know a lot about a hospital's infection rate.   It
    seems to me that there is no better indicator of poor quality than hospitals
    which make people sick.
              I want to express my thanks to the witnesses for being here this
    afternoon.  I am particularly anxious to hear from Dr. Haley about the status
    of the Texas reporting law, and I look forward to learning from these
    distinguished experts how we can stem the tide of hospital-acquired
    infections and make sure that consumers get the information that they need
    to make informed health care decisions.

    	MR. WHITFIELD.  Thank you, Chairman Barton.
    	At this time, I recognize the gentlelady from Colorado, Ms. DeGette.
    	MS. DEGETTE.  Thank you very much, Mr. Chairman.
    	Mr. Chairman, every year, thousands of people are injured or die
    unnecessarily because of infections that they contract as patients in a
    hospital.  Too often, these are infections that could be easily prevented
    and in many cases, just making one small change is all it would take to
    save a life.
    	Hospitals that have made a commitment to reducing infections have
    seen substantial benefits, both to patient care and to their bottom line.  As
    this morning's Washington Post noted, though, while the medical
    community is well aware of the risks of contracting an infection during a
    hospital stay, we do not have enough quantifiable data to support making
    necessary changes.  The CDC has maintained a database of hospital-
    acquired infections since the 1970s, but this database only includes data
    from 300 hospitals.  The CDC has recently expanded data collection on
    hospital-acquired infections through its new National Healthcare Safety
    Network, but the data remains insufficient to truly understand the
    problem.
    	Mr. Chairman, I would suggest that we need to do more to support
    increased reporting of hospital-acquired infection data, but we also have
    to ensure that the process by which we collect this data and the method
    used to disseminate the information are effective.  We need to have a
    standards-based approach to see how hospitals collect data on infections
    that will enable apples to apples comparisons.  If we are going to have an
    accurate picture of infections throughout the country, the data cannot be
    ambiguous.
    	As part of this, we must not forget to include qualifying information
    on infection data.  As some of the witnesses will address in their
    testimony today, some hospitals may indeed have patients who are
    unhealthier than on average, and so have greater numbers of co-
    morbidities.  We need to have an infection reporting system that includes
    collection of this qualifying information so that all hospitals will be
    judged fairly, and using this qualifying data will also prevent hospitals,
    in the other direction, hiding behind excuses.
    	How we report this data is just as important as how the data is
    collected.  Some have suggested that we should aggregate infection data
    into one collective grade for each hospital.  Consumers would compare
    hospitals in their area then based on overall infection rates.  This type of
    reporting concerns me in that all hospitals provide different services, and
    aggregation can often be misleading.  I believe we need a more
    sophisticated method of comparing data from hospitals, examining types
    of infections, so we can get a more complete picture.  Having more
    nuanced reporting will also help Federal agencies to provide needed
    assistance to hospitals looking to improve infection rates.
    	At the same time that I support increased data collection of hospital-
    acquired infections and improved reporting systems, I think this is
    merely the first step.  We need to look at better ways to use this data.
    Maybe some patients will go online to verify the infection grade when
    deciding which hospital to select for surgery, although I suspect the
    Chairman probably didn't have time to go online before he ran over to
    the hospital when he had his heart attack.  In most cases, patients don't
    even have a choice when it is non-emergency where they obtain their
    care.  So I don't think that we can rely solely on market forces to
    improve infection rates.  Reducing infection rates must be addressed in a
    much more comprehensive way.
    	Correctly reporting and analyzing data is just the first step we need
    to take before tackling the bigger problem of reducing these infections.
    And as I am sure we are going to hear from Dr. Shannon later, Allegheny
    General Hospital was able to reduce bloodstream infections by
    standardizing procedures and reviewing each case of infection within 24
    hours.  We need to figure out how to replicate the response to infections
    that places like Allegheny had.  We also need to develop evidence-based
    best practices that can be utilized by all hospitals to reduce infection
    rates.
    	Mr. Chairman, lowering infection rates in hospitals is about a
    continuum of care.  Our system must collect infection data in a
    standardized format.  The data then must be reported to various
    stakeholders, including patients, in the most effective way possible.  We
    need programs in place to help hospitals employ best practices to lower
    their infection rates, and finally, we need to examine data over time to
    verify improvement so that we can make changes where necessary.  This
    is how we will make lasting change.  Yes, we need to examine how we
    report data, but what we really need to do, Mr. Chairman, is to talk about
    how we can use that data to reduce infections in hospitals.
    	Thank you.
    	MR. WHITFIELD.  Thank you, Ms. DeGette.
    	At this time, I recognize Mr. Ferguson of New Jersey for his opening
    statement.
    	MR. FERGUSON.  Thank you, Mr. Chairman.  Thank you for holding
    this important hearing.
    	Today is my mom's birthday.  She would have been 62 years old
    today.  She died 2 1/2 years ago at 59.  She fought bone marrow cancer
    for six years, and she was in and out of hospitals all the time.  For six
    years, she and our family spent an enormous amount of time--and any
    one of you who knows has been through that, either yourself or with
    someone you love--know how much time you spend in a hospital.  She
    had a bone marrow transplant, she had a compromised immune system
    for better part of five years, and we were constantly in fear that she
    would contract some sort of illness, an infection of some sort, that would
    literally kill her.  Fortunately, she had great medical care.  She was in
    wonderful hospitals and had professionals who helped her, and she lived
    6 years with this disease and got to meet three of her grandkids.  It is a
    great story.  She would have been 62 today, so I think about her a lot,
    particularly today.  But it highlights a very, very important issue, which
    many, many, many Americans face, sometimes without very good
    results, and that is why I am very pleased, Mr. Chairman, that you are
    holding this hearing.
    	The CDC estimates that two million Americans contract infections
    during the course of a hospital stay, and 90,000 of them die from the
    infection that they acquired.  In our hospitals today, physicians and
    nurses are fighting what seems like a never-ending battle against an
    invisible enemy, and today we are fighting new germs that are resistant
    to some antibiotics.  At the same time, hospitals see the sickest patients,
    the elderly and the young, whose immune systems, like my mom's, have
    been compromised and may be more susceptible than yours or mine to
    germs.
    	To win this battle, infection control has to be everybody's job.  And I
    remember every time we went into the room to see my mom, we would
    have to get our anti-bacterial gel and wipe our hands down, and anything
    else that may have been carrying germs.  Hospitals have a long track
    record of working at preventing infections, and are already reporting
    infection prevention measures.  I believe the information has to be
    meaningful and has to be comparable.  The information shared should
    focus on infections that have the potential for the greatest consequences
    to patients, areas where clinically proven prevention efforts exist and
    areas where good solid data exists.
    	Today, more than 1,300 hospitals are sharing information about
    infection prevention on a public website, and in the coming year
    additional information will be shared specific to surgical infections.
    Through the Institute for Healthcare Improvements 100,000 Lives
    Campaign, more than 3,000 hospitals are implementing one or more
    evidence-based interventions and establishing new standards of care.  For
    example, in my home State of New Jersey, a consortium of 23 teaching
    hospitals has reduced their bloodstream infection rates by 50 percent, and
    in their intensive care units, the rate of ventilator-associated pneumonia
    has been reduced by 75 percent over a 9-month period.  This is definitely
    a step in the right direction, but maybe more can be done, and that is
    what we have to figure out.
    	I look forward to hearing from our panels today.  Thanks very much
    to our witnesses all for being here today to help us gain new insights into
    the best ways that we can track this phenomenon and work in ways to
    curb its danger.
    	Thank you, Mr. Chairman.  I yield back.
    	MR. WHITFIELD.  Thank you, Mr. Ferguson.
    	Dr. Tim Murphy is a member of the full Energy and Commerce
    Committee.  He is not a member of the Oversight and Investigations
    Subcommittee, but he has had a special interest in hospital infection
    rates, and I would ask unanimous consent that he be allowed three
    minutes to give an opening statement, if there is no objection.
    	Mr. Murphy, you have three minutes.
    	MR. MURPHY.  Thank you, Mr. Chairman.  I appreciate the special
    privilege of being allowed to speak.
    	You know, if an airplane went down in America today, we would
    send every Federal agency around to investigate it.  If another plane went
    down tomorrow, we would be alarmed at this.  And if a plane went down
    the next day, we would shut down the airline industry.  Curiously
    enough, more people die in America every day from an infection they
    may pick up while seeking medical care.
    	Now, the thing about this is we are facing some 90,000 deaths a year
    according to the CDC, far more than died in Vietnam.  We are facing an
    enemy that is microscopic, and yet one that we can kill off before it kills
    us by things as simple as taking some gel and wiping your hands off
    before you see a patient, making sure supplies and other instruments are
    cleaned up before we see patients.  But oftentimes, that doesn't happen.
    	When I was visiting a relative in a hospital, I watched someone come
    in who had gloved and scrubbed before they came in and began to handle
    this patient's IV line, until I stopped them and asked them to fix it up and
    to say wash their hands again.  It is a concern that happens, and yet
    despite the deaths, despite the problems, we continue this on too long.
    Medicare and Medicaid pay billions of dollars a year in this care that we
    could be preventing, and the loss of life goes on.  However, a number of
    hospitals have done some remarkable things to turn this around.  We are
    going to hear today from Dr. Richard Shannon, the Chair of the
    Department of Medicine at Allegheny General Hospital, who I greeted
    over there today as a hero in what he has done to really actively save
    lives and turn a hospital around.
    	We will also hear from Mr. Mark Volavka of the Pennsylvania
    Healthcare Cost Containment Council, who will talk about some research
    that they have found in Pennsylvania among hospitals that are reported
    with some of their data to tell us what is going on.
    	It is a serious concern, and I believe as we look at things that
    Congress talks about and argues about in the area of healthcare,
    oftentimes we are talking about who is going to pay for the expensive
    costs of healthcare.  We may argue about health savings accounts or
    association health plans or single payer having the Government to take
    over.  None of those will work to drive costs down in healthcare like
    taking care of infection rates.  In fact, the issue is so staggering, I wonder
    why we have not taken action before.  I think the action of this
    committee is courageous in what it is doing.  We could actually find all
    the savings we are looking for in Medicare and Medicaid if this was the
    only thing that Congress did for the rest of year.  It could actually do a
    whole lot towards balancing the whole budget and taking care of these
    issues.  That is why I am introducing legislation to establish pay for
    performance incentives through Medicare to greatly incentivize
    providers to continue their efforts to reduce infections and save
    thousands of lives.
    	So amidst the horror stories that may be out there--we may hear
    some today--the shining light is that it can be done.  I know in hospitals
    that I worked at, I have seen them turn this system around, and we have a
    lot to be proud of from what hospitals have done, and we need to find
    ways of continuing to encourage hospitals around the Nation to do this.  I
    know that some of the VA hospitals have taken the lead on these issues,
    and you can't go by a room or a hall without finding some sort of
    dispenser of some sort of alcohol or other gel to make sure you wash and
    clean up.  We also need to be telling patients' families the same thing
    when they come in to visit.
    	So, Mr. Chairman, thank you so much for doing this.  As we
    approach this, I hope we are all careful at looking at the methodology of
    these studies and being able to apply them in a cost-effective and
    efficient way as we tackle this terrible enemy of infections.
    	Thank you, Mr. Chairman.
    	MR. WHITFIELD.  Thank you very much.
    	Today, we have three panels of witnesses, and on the first panel we
    have Dr.--not doctor, but you probably feel like a doctor by now.
    	MR. WAGNER.  I have begun to.
    	MR. WHITFIELD.  Mr. Raymond Wagner, Jr., who is a Legislative
    Vice President and Legal Vice President of Enterprise Rent-a-Car, and
    he is going to relate to us a personal experience that he had with his son,
    Raymond, and also, we are going to hear from him about his
    involvement in passing legislation in the State of Missouri on this very
    topic.
    	So before we begin, Mr. Wagner, you are aware that the committee
    is holding an investigative hearing, and when doing so, we have the
    practice of taking testimony under oath.  Do you have any objection to
    testifying under oath today?
    	MR. WAGNER.  No, Mr. Chairman.
    	MR. WHITFIELD.  And I am assuming that you do not have any legal
    counsel, so if you would stand I would like to swear you in.
    	[Witness sworn.]
    	MR. WHITFIELD.  Thank you.  You are now sworn in, Mr. Wagner,
    so if you would turn on your microphone, we look forward to your
    opening statement.

                  STATEMENT OF RAYMOND T. WAGNER, JR., LEGAL AND
                  LEGISLATIVE VICE PRESIDENT, ENTERPRISE RENT-A-
                                        CAR

    	MR. WAGNER.  Mr. Chairman, members of the committee, thank you
    for the opportunity to appear before you today.  My name is Ray
    Wagner.  I am from St. Louis where I am employed by Enterprise Rent-
    a-Car, as you stated.  I do not appear today as a representative from my
    company; I appear today as a father.
    	You heard the statistics in the opening statements, and yet there
    seems to be a quiet paralysis in the medical and hospital community
    about what to do about these infections.  I appear today before you
    because my son is one of those nameless, faceless statistics you heard
    about and you read about all too often today.
    	On Christmas Eve, 2002, my son Raymond went out to ride his sled
    and he suffered a break to his left elbow from falling from his sled.  He
    needed surgery.  The surgery appeared to go well and Raymond was
    discharged on Christmas Day, 2002, his 14th birthday.  A fever developed
    and persisted.  To make a year-long story very short, Raymond had
    acquired a staph infection, which developed into osteomyelitis.  In total,
    he endured six additional surgeries and surgical procedures.  Raymond
    spent several weeks in the hospital.  He endured bone scans, CAT scans,
    ultrasounds, countless x-rays, aspirations, hearing tests, kidney tests, just
    to name a few.  He can tell you about one surgery where he was awake
    with his eyes closed because he was not given enough anesthesia for a
    boy his size.  He remembers every detail of that surgery.  Raymond spent
    many months on a PIC line--with a PIC line threaded up his arm into his
    chest muscles to inject antibiotics.  When his veins collapsed and he
    could no longer sustain the PIC line, he received a Broviac catheter
    pump, which was surgically embedded into his chest, again for several
    months.  There were regular visits from the home health professionals for
    wound cleanings, broken equipment, pulled catheter lines, and concerns
    of new infections.  He managed a very structured antibiotic pill regimen
    for many months thereafter as well.  He spent countless hours in physical
    therapy to stretch his arm, which had frozen into a right angle.
    	Of course, Raymond missed school.  He missed baseball, swimming,
    football his freshman year, and lifeguarding that summer.  We were
    devastated each time we learned that the infection had returned and he
    needed one more surgery.  One very poignant moment came as we were
    talking to the team of doctors over his bed one evening, and one doctor
    looked at our little boy in his bed and asked if he had any questions.  He
    replied "Yes.  Am I going to die from this?"  We assured him that he
    would not die.  We would not let that happen.  His mother and I looked
    at each other; we were not so sure.  Raymond next asked "Am I going to
    lose my arm over this?"  And let me show you a brief clip.  We will
    come back to that, but that was Raymond in the hospitals after one of his
    surgeries.
    	Today, we believe Raymond's infection is cleared up.  We thank
    God and we consider ourselves to be among the lucky ones.  Our son is
    alive.  We spent several thousand dollars in miscellaneous expenses as
    well associated with Raymond's treatments, including co-pays,
    deductibles, out-of-pocket, network expenses, un-reimbursed expenses,
    et cetera.  The overall costs to the health system must be staggering, as
    was alluded to in the opening statements.  And of course, we had
    ongoing battles with certain providers about expenses and coverage
    which took over two years to resolve.  There were also the lost days of
    work for Raymond's mother and me.
    	The question which haunted me as a parent was how could this have
    happened to us?  We live in a community with more than a dozen
    excellent, highly regarded hospitals.  How could we have known that the
    hospital we chose might be more likely to threaten his life?  The answer
    was that we simply could not have known.  There was no form of public
    or non-public reporting of hospital-acquired infections.  So Raymond and
    I started an effort to require public reporting in Missouri.  We worked to
    develop a model bill with the Consumers Union, which had then just
    undertaken a major initiative to address this subject.  We joined forces
    with a State representative who is also a practicing medical physician.
    We enlisted the support of the State Hospital Association.
    	In short, Missouri Senate Bill 1279 requires the Department of
    Health to make available on their website risk-adjusted infections for
    certain types of infections, after consulting with an advisory committee
    and the CDC.
    	1279 passed the legislature in a single session nearly unanimously.
    Raymond spent time before the legislature.  His story received
    considerable attention.  The bill widely became known as "Raymond's
    Bill."  Lobbyists, legislators, and staff all freely and willingly joined in
    the effort because of their own experiences.  While the effort was
    predominantly consumer and patient driven, business groups and hospital
    medical groups ultimately embraced the topic.
    	I know that it is not as easy as simply reporting raw data on hospital-acquired infections, but to let these doubts and issues overcome any
    solution or serious effort to address the problem would do a grave
    injustice to the victims of hospital-acquired infections.  The Missouri
    Department of Health and its advisory committee are addressing the
    concerns that often are raised.  My written statement addresses these in
    more detail as well.  All of these challenges can be overcome by proper
    guidance and instruction at the State and Federal level, experience in
    gathering statistics, and developing reports.  I think much can be learned
    from the growing volume of State experiences.
    	It has been important for me to underscore that our involvement has
    never been about assigning any blame or embarrassment to any hospitals.
    We certainly never considered any legal recourse as a result of
    Raymond's surgeries.  I have never publicly named any of the hospitals
    or the doctors involved in our case.  Our simple goal was to put a
    spotlight on the growing issue of hospital infections.  In my opinion,
    hospitals were not leading the discussion as they should.  This, I believe,
    is why you see consumers and patients across the country demanding
    attention on this issue.
    	I hope and look forward to this committee and Congress studying all
    approaches under consideration.  I urge you, the medical community, and
    the hospital community to embrace the issue and to earnestly look for
    solutions with a level of commitment that they have not shown to date.
    This effort needs their expertise.  Please include individual consumers in
    the process, people such as myself who have been touched by hospital-
    acquired infections.  This effort needs their motivation.  Together, I
    believe we can make huge advances so that other hospital patients do not
    have to become a statistic like my son Raymond.
    	Mr. Chairman, thank you, and with the Chairman's permission, I
    would like to attach to my statement a statement from my son who could
    not be with us today, and he has a brief video which, with your
    permission, I could show right now.
    	[The prepared statement of Raymond T. Wagner, Jr. follows:]

    PREPARED STATEMENT OF RAYMOND T. WAGNER, JR., LEGAL AND LEGISLATIVE VICE
                           PRESIDENT, ENTERPRISE RENT-A-CAR

            Chairman Barton, Chairman Whitfield, Members of the Committee,
    Thank you for the opportunity to appear before you today to speak about this
    very serious issue of hospital-acquired infections.
            My name is Ray Wagner. I am from St. Louis, Missouri.  I am employed
    by Enterprise Rent-A-Car where I serve as the Government Relations and
    Legislative Vice-President.  However, I do not appear before you today as a
    representative from my company. I appear before you today as a father.
             I thank this Committee for involving itself in this issue. As you
    will undoubtedly learn, this growing phenomenon of hospital-acquired
    infections is reaching epidemic proportions.  It is time that state and
    Federal policy makers undertake a comprehensive, and even coordinated, look
    at these infections. The Center for Disease Control has estimated that 90,000
    deaths per year are caused from hospital infections.  Nearly 3/4 of the
    deadly infections or about 75,000 were preventable according to the CDC,
    the result of unsanitary facilities, germ-laden instruments, unwashed hands,
    and other lapses in hospital practices. Astoundingly, deaths linked to
    hospital germs represent the fourth leading cause of mortality among
    Americans, behind major heart disease, cancer and lung ailments according to
    recent studies.  These infections kill more people each year than motor
    vehicle accidents, fires and drownings combined. In addition, according to
    Consumers Union, one in 20 hospital patients will get an infection while
    being treated for an unrelated health care problem, thus translating to
    almost two million patients each year. And yet, it seems there has been a
    quiet paralysis in the medical and hospital community about what to do about
    this problem.
            I appear before you because my family is one of these statistics.
    My son is one of those nameless, faceless statistics which we read about all
    too often with increasing frequency on an almost daily basis.
             I will begin by telling you a bit about the nosocomial infection or
    staphylococcus aureus infection which infected my son, Raymond Wagner III.
    Today, Raymond is a healthy junior in high school.  He is an honor student,
    currently studying in Europe at the International School of Luxembourg while
    my wife is working in Luxembourg for the time being.  Raymond wishes he could
    be here, but that is not possible under the circumstances. On his behalf, I
    have submitted his brief statement for the record.  And, with the Chairman's
    permission I have a brief video which I would like to show at the end of my
    remarks.
            On Christmas Eve, December 24, 2002, the day before Raymond's 14th
    birthday, we had a beautiful snow fall in St. Louis.  That afternoon, Raymond,
    then 13, went out to ride his sled behind our house with some friends. While
    he was playing, he suffered a serious break to his left humorous bone from
    falling off his sled as he was coming down the hill.  When his brother raced
    in to tell us about the accident and I saw Raymond moments later, I knew
    instantly that we had a problem.  We put him in the car. I drove him on the
    snow-covered roads to a local hospital.  Once in the hospital, pain
    medication was administered and X-rays were taken.  As was immediately
    clear from the X-rays, the orthopedic surgeon on call explained that he
    would need surgery on his left arm due to the seriousness of the break.
            After consulting with his pediatrician, we calmly and coolly
    determined to move him in an ambulance to a different hospital where he
    would be attended to by a more experienced surgeon specializing in pediatric,
    orthopedic surgeries.  His surgery appeared to go well, although he received
    a screw and two pins in the area of his elbow.  Raymond was discharged the
    next morning, on Christmas day, also his 14th birthday.
            In the following days, a fever developed and persisted. There were
    several immediate trips to the hospital where we were told that such a fever
    was normal following such a traumatic break.  To make a nearly year long
    story very short, Raymond had acquired staph infection which also developed
    into osteomyelitis, meaning the infection had burrowed into his bones.  In
    total, he endured six additional surgeries and surgical procedures following
    the initial surgery.  All of this, we firmly believe resulted from his broken
    arm. It was a serious break, but one without a cut or tear to the skin when
    he arrived in the hospitals.
            Cumulatively, Raymond spent several weeks in the hospital. It seemed
    all too often we were meeting with his medical team of orthopedic surgeons,
    infectious disease doctors, pediatricians and nurses only to learn that we
    had not yet rid his body of this invader, and that we needed one more surgery.
    We were devastated each time we were informed that the infection had returned.
    He endured bone scans, CAT scans, ultra-sound scans, X-Rays, aspirations,
    hearing tests and kidney tests due to the strong medicine, all to name just
    a few procedures.  He can even tell you about one surgery he well remembers
    where he was awake with his eyes closed during the surgery because he was
    not given enough anesthesia for a boy his size; he remembers every detail
    of that surgery.
            During the ordeal, Raymond spent many months with a "PIC line"
    inserted into his arm.  In this procedure, a plastic catheter tube was
    inserted through his veins in the area of his wrist where it was threaded up
    his arm and into his chest muscle to inject antibiotics into his upper body.
    The line originated from a pump strapped around Raymond's waist for several
    months, 24 hours per day.  When the veins in Raymond's arm failed and he
    could no longer sustain the PIC line, he received something known as a
    "Broviac catheter pump."  This was surgically imbedded into his chest
    cavity right above his heart, again connected to a strapped pump for several
    months. And, there were regular visits from the home health professionals
    for wound cleanings, broken equipment, pulled catheter lines, and concerns
    of further infections.  Fourteen year old Raymond became extremely adept at
    changing his dressings and antibiotic packets.
            Once the Broviac pump was removed from his chest, Raymond underwent
    a very structured antibiotic pill regiment for many months.  He consumed two
    large pills at exactly 6:00am, noon, 6:00pm and midnight.  He spent countless
    hours in physical therapy to stretch his arm, which had frozen into a right
    angle during the course of his surgeries and subsequent casts and braces. He
    dutifully engaged in many months of early morning and evening stretching
    exercises to regain the full use of his arm.
            Needless to say, Raymond missed many days of school.  He was,
    however, able to perform the role of the Cowardly Lion in his 8th grade
    school play, the Wizard of Oz; he was escorted from the hospital by a nurse
    and he was returned to the hospital right after the play that evening where
    he was reconnected to his lines and monitoring devices. Raymond missed
    baseball that spring, swimming that summer, and most unfortunately - in his
    mind - football that fall, his freshman year in high school.  He was also
    scheduled to be a junior lifeguard during that following summer. He had
    competed for one of these few positions and he was excited for the
    opportunity.  He was able to remain working for the pool, although he was
    forbidden from getting wet. Raymond spent that summer monitoring the pool
    deck for running children.
            My family and our relatives, friends and colleagues endured many
    days of anxious agony. One very poignant moment captures the essence of the
    agony of this whole experience.  As Raymond's mother and I were talking to
    the team of infectious disease doctors and other doctors over his bed one
    evening, one doctor looked at our boy in his bed and asked if he had any
    questions. He replied, "Yes. Am I going to die from this?" We assured him
    that he would not die; we would not let that happen to him.  His mom and I
    looked at each other. We were not so sure.  Raymond next asked, "Am I going
    to lose my arm?" Again, we assured him that would not happen.  We told him
    we would go anywhere and do anything we needed to ensure that he would not
    loose his arm. (Then he pushed the envelope too far and asked if he would
    be able to play football at St. Louis University High School in the upcoming
    fall of his freshman year in school.  He served as the team manager that
    freshman season and waited until his sophomore year to play.)
            Today we believe Raymond's infection is cleared up.  Although, one
    cannot be certain for sure; the staph infection may spring back to life
    someday with a slight trauma of some sort.  In addition, Raymond is unable
    to fully extend or flex his arm, even though it is fully functional.  We want
    to believe we are through the most difficult stages.  We thank God and we
    consider ourselves to be among the lucky ones in light of what these
    infections are doing to thousands of families across the country each year.
            Aside from the very real human emotional costs, another dimension to
    this problem is the financial costs to victims of hospital-acquired staph
    infections. We spent several thousand dollars in miscellaneous expenses
    associated with Raymond's treatments, including co-pays, deductibles, out
    of network expenditures, unreimbursed expenses etc. And, of course, as is
    probably all too common, we had ongoing battles with certain providers about
    expenses and coverages which took over two years to resolve.  From my
    conversations with many others who have endured hospital-acquired infections,
    they have suffered similar financial experiences and strains.  And, of
    course, there were the lost days of work for Raymond's mother and me.
            We were not content to simply thank our lucky stars.  Raymond had
    suffered too much and the family had made too great a sacrifice to not see
    something positive come out of this ordeal.  We kept telling Raymond
    throughout his treatments that something good would come from this. Yet,
    the question which haunted me, as a parent, throughout all of this was:
    How could this have happened to us?  We live in a community with more
    than a dozen excellent, highly-regarded hospitals.  I had even transferred
    my son on the evening of his accident from one hospital to another where I
    thought he might receive better care from the specialist on call that
    evening.  How could we have known that the hospital we chose might be more
    likely to cause our son a hospital staph infection which threatened his life?
    The answer at that moment was that we simply could not have known whether
    one hospital was more prone to cause infections over another hospital in
    our community.  There was no form of public or non-public reporting or
    comparisons of hospital-acquired infection rates.
    ----------
      Missouri statutes and regulations are replete with reporting requirements
    for other issues.  For example, genetic and metabolic diseases in newborns
    are reportable to the department of health.  Animal bites are to be reported
    to the department of health.  Hospitals are to report AIDS, arsenic poisoning,
    carbon monoxide poisoning, different venereal diseases, mercury poisonings,
    hepatitis, lime disease, mumps, pesticide poisoning, respiratory diseases
    triggered by environmental contaminants, rocky mountain spotted fever,
    salmonellas, tetanus, toxic shock syndrome, West Nile fever and even leprosy,
    only to name a few.  Yet staph infections were not reportable and the
    information was not collected by the department of health in any fashion.
    Any yet staph infections are the fourth leading cause of death in this
    country behind heart disease, cancer and lung ailments.

            Standing in line at the pharmacy to refill a prescription for
    Raymond, I saw the February 2003 publication of Readers Digest. The cover
    read "FATAL HOSPITAL MISTAKES How to Avoid Them."   I found myself reading
    the entire related article entitled "Death Beds.  Dirty hospitals kill
    75,000 patients a year. Unnecessarily." before I left the pharmacy.  The
    basic premise of the article was that hospitals do have the capacity to take
    steps to minimize staph infections; the article underscored that there is
    little government regulation to force hospitals to step up infection control.
    About the same time, I learned that Pennsylvania and Illinois had passed laws
    to require public reporting.
            Inspired by this article and the actions in Pennsylvania and
    Illinois, Raymond and I discussed the idea of starting an effort to require
    public reporting in Missouri. It was too late at that point for the 2003
    session, so we focused on the next 2004 legislative session.  I wrote a
    draft, starting with the Illinois and Pennsylvania reporting laws, as well
    as concepts from other Missouri reporting laws. I contacted the Consumers
    Union which had just undertaken a major initiative to address the subject of
    hospital-acquired infections.  I am very grateful to the Consumers Union
    for its tenacious efforts which can be reviewed at
    www.stophospitalinfections.org, and in particular Lisa McGiffert who is
    here today. Together, we prepared a model bill which we would introduce in
    Missouri and hopefully other states around the country.  (Legislation has
    been introduced in 30 states this year and six states have passed reporting
    bills: Illinois, Pennsylvania, Missouri, Florida, Virginia and New York.)
            With this first draft of a public reporting type bill in Missouri,
    we joined forces with a then-freshman State Representative who is also a
    practicing medical physician.  Dr. Robert Schaaf had a very keen interest
    in hospital-acquired infections.  We approached the Missouri Hospital
    Association and ultimately enlisted their help and support in refining a
    bill that would be workable and acceptable to the hospitals.  From this
    effort, Senate Bill 1279 was introduced.
            In short, SB1279 requires the department of health to make
    available on their website risk-adjusted infection rates for certain types
    of infections such as class I surgical site infections, ventilator-
    associated pneumonia, central line-related bloodstream infections, and
    other infections defined by rule by the department. The bill also requires
    hospitals to monitor for compliance with infection control regulations.
    The bill required the department of health and an advisory committee of
    mostly medical experts to work out the technical, finer details of the
    reporting system.  This bill provided effective dates well off into the
    future in order to allow the department, the advisory committee and the
    medical community sufficient opportunity to develop specific guidelines
    to deal with these important matters.  In addition, this bill directed
    the advisory committee to draw upon the considerable body of expertise
    and methodology established by the Federal Centers for Disease Control
    and Prevention National Nosocomial Infection Surveillance System.

            The simple philosophy behind this bill is that a certain level of
    public reporting on hospital-acquired infections will serve the public in
    two ways.  One, patients will be given an opportunity to evaluate their
    health care facility choice and therefore make more informed decisions.
    More importantly, hospitals will work diligently to improve their outcomes
    on publicly reported indicators which will help facilitate the adoption of
    best practices of patient care  (hand washing, surgery prep, cleanliness,
    etc) thus minimizing such infection rates in hospitals.
            Prompt passage of SB 1279 proved very successful. The effort had
    enthusiastic sponsors in both Chambers of the legislature.  The process was
    transparent and inclusive of all concerned.  SB 1279 passed the legislature
    in a single session.  It passed unanimously in the Missouri Senate and with
    all but one vote in the House of Representatives. The Governor signed the
    bill in a large signing ceremony.
            My son Raymond and I testified before the Missouri legislature.
    We together visited and called legislators about the bill. His story
    received considerable attention.  The bill became widely known as "Raymond's
    Bill".  During that process, it became apparent about how many people are
    affected by hospital-acquired staph infections.  Lobbyists, legislators and
    their staffs all freely and willingly joined in the effort because of their
    own experiences.  The various business groups and consumer groups all saw the benefits to be derived from SB1279.  While the cause was predominantly
    consumer and patient driven, the hospital association and other medical
    groups ultimately embraced this issue in an effort to do something
    constructive to address these staph infections.
            Notwithstanding the benefits of disclosure and public reporting, I
    have come to recognize that it is not as easy as simply reporting raw
    incidences of hospital-acquired infections to a department of health for a
    public report. A system must address issues relating to the patient-base or
    type of the hospital, the types of infection, the disparate statistic
    gathering practices within those hospitals, and so on.  Each of these must be
    taken seriously. But, to let these doubts and issues overcome any solution or
    serious effort to address the problem would be a grave injustice to the
    victims of hospital-acquired infections.
            Some critics of public reporting have said a reporting law can not
    be consistently applied from hospital to hospital. They contend it would
    cause hospitals with scrupulous reporting practices to look unfavorable as
    compared to hospitals with less- meticulous practices. While I recognize the
    complexity of the task, I don't accept this premise.  As a society, we are
    able to apply health codes to rate all kinds of restaurant establishments.
    We are able to apply a complex set of state and Federal tax codes to every
    type of business, as well as individuals.  We have building codes, traffic
    codes, uniform labor codes, all to name just a few. I believe these
    challenges can be overcome with proper guidance and instruction at the state
    and Federal level, experience in gathering statistics, potential adverse
    licensure consequences for intentional under-reporting, etc.
            Some say that public reporting will be flawed due to differences in
    the types of hospitals and the practices and services they offer.  A rural
    hospital and an urban hospital will have different reportable experiences;
    a teaching hospital and non-teaching hospital will have different reportable
    experiences; a critical-care hospital will  have different experiences; and
    so on.  I believe states are developing valuable experiences to address
    these issues.  Missouri, for example, has developed categories for hospitals
    and surgical procedures.  The Missouri statute also calls for risk-adjusted
    assessments.  I think much can be learned from the growing volume of state
    experiences.
            Some raise the difficulty in distinguishing between hospital-acquired
    infections and community-based staph infections which also are reportedly on
    the rise. There is concern that any hospital reporting system may falsely
    include staph and other serious infections acquired outside of the hospital.
    Reporting systems will have to be sensitive to this.  In Missouri, the law
    focuses primarily on Class I surgeries i.e., surgeries where the patient
    does not have an open wound upon arrival in the hospital.  In my son's case,
    he arrived at the hospital with no broken skin.  Surgery was performed on his
    left elbow. The infection and osteomyelitis was located at the surgery site.
    It was clear to me that this was likely a hospital-acquired infection, not a
    community-based staph infection.  On the other hand, patients arriving in the
    hospital burn unit should not be placed in the same category as Class I
    surgery patients.
            I spoke earlier of the financial cost to my family. I would venture
    to say that the overall cost on the national health system for hospital
    acquired infections is staggering.  And so much of it can be avoided.  I
    mentioned the costs to my family and the several thousand dollars this cost
    us.  The balance of most of those costs was covered by my health insurance
    carrier. Ultimately, in theory, employers absorb these costs the following
    year through increased co-pays, higher deductibles, etc. And for those
    victims of staph infection who have no insurance, the system as a whole
    absorbs those expenses. At that point, all consumers and taxpayers pay. I
    can not begin to quantify what must be a very large amount, but it becomes
    easy to see that all of us are absorbing a tremendous cost, much of which
    might be avoidable if hospitals reduced the incidences of these infections.
            During the course of our work on Missouri SB1279, it was important
    for me personally to underscore that our involvement in this cause, like
    our involvement here today, was never about assigning any blame or
    embarrassment to any hospitals for my son's staph infection. Nor is it about
    in any way disparaging hospitals or the important work they do. We certainly
    never considered any sort of legal recourse.  I personally, have nothing
    but gratitude and respect for the doctors, the scientists, their teams and
    hospitals involved in my son's case. I have never publicly named the
    hospitals or doctors involved in my son's case.   Our simple goal was to
    help put a spotlight on a growing very serious problem. We wanted to
    stimulate discussion about how imperative it is for hospitals to reduce
    their infection rates by all available means. In my opinion, hospitals
    were not leading this discussion, as they should.  This is the positive
    outcome we wanted to see come from Raymond's ordeal. In Missouri, the
    policymakers concluded that public reporting was the most important way for
    consumers to pick the best and safest hospitals. Other states are adopting
    similar measures, and still other states are taking other approaches. I can't tell you for sure that Missouri has adopted the best approach.  I hope
    that in ten years we will look back on the Missouri approach and recognize
    that it was a good first step, but that it evolved and improved.
            I respectfully ask this Committee and Congress to study all of the
    approaches under consideration by the states today, as well as the Centers
    for Disease Control. I encourage you to collaborate with CDC and other
    government experts to study what works.  I encourage you to include the
    medical community and hospital community.  I urge them to embrace this issue
    of hospital-acquired infections and to earnestly look for solutions to
    this major health threat with a level of commitment they have not universally
    shown to date. This effort needs their expertise.  And, I believe it is
    critically important to include individual consumers in this process, people
    such as myself who have been touched by hospital-acquired infections. This
    effort needs their motivation.
            Together, I believe we can make huge advances toward minimizing the
    devastating consequences of these all too frequent infections so that other
    hospital patients do not have to become a statistic like my son, Raymond.
            Thank you, Mr. Chairman and Members of the committee.

                        PREPARED STATEMENT OF RAYMOND T. WAGNER III

            Mr. Chairman and Members of the Committee:
            My name is Raymond Wagner.  Thank you for allowing me to speak to
    you today.  I just wanted to add that I appreciate the Committee for
    considering this issue of hospital-acquired infections.  As my Dad outlined,
    I had a tough time during that year following my sledding accident.  I
    missed a lot during that year, but I also grew a lot.
            I am very thankful to the doctors who helped cure my infection.  I
    am also thankful to my Mom and Dad and all of my friends and teachers who
    helped me.
            I think this hearing is a good way to begin to look at this problem
    of hospital staph infections so that no other teenagers like me, or new
    babies, or older people like my Grandparents have to go through what I went
    through and my family went through.
    Thank you very much.

    	MR. WHITFIELD.  Without objection, go ahead.
    	[Video.]
    	MR. WHITFIELD.  Well, thank you, Mr. Wagner, and we appreciate
    that video from your son.
    	Your son was injured December 24, 2002--
    	MR. WAGNER.  Yes, sir.
    	MR. WHITFIELD.  --and he had surgery and went home, what, the
    next day or two, right?
    	MR. WAGNER.  The next day.
    	MR. WHITFIELD.  And then how long was it before he received a
    clean bill of health from the infection being over with?
    	MR. WAGNER.  He took his last antibiotic pill on Thanksgiving Day
    the following year, so it was nearly a full year later, and then we return to
    the doctor periodically every couple of months for the following year, so
    it was approximately maybe during the second year that we felt that we
    were out of the woods.  So it was over a year process.
    	MR. WHITFIELD.  I do appreciate your testimony.  Now, in your
    testimony, you used the word "quiet paralysis."  You said that there's
    been a quiet paralysis in the medical and hospital community.  Now,
    would you elaborate on that a little bit for me?
    	MR. WAGNER.  Yes, sir.  In my experience, both as a father of
    Raymond, the patient, and in my subsequent involvement in this effort to
    pass a law in Missouri, it became fairly clear to me that hospitals have
    not, up to that point, embraced this issue fully.  They were oftentimes
    resistant to the public reporting.  I know that there are many issues which
    need to be addressed which were highlighted in the opening statements
    and are highlighted in my statement as well, but the word infection is a
    difficult word for even hospitals to speak when you are there as a patient,
    or in my case, the father of a patient.  We really weren't told that we had
    a staph infection until well into his treatments for these sorts of things,
    and so I think that there's been resistance.  Certainly as I have tracked
    legislation in other States across the country, oftentimes it is the hospital
    that is resisting adopting any sort of legislation and taking this first step
    to dealing with this problem.
    	MR. WHITFIELD.  So I take it during this process, you had a number
    of discussions with the hospital administrators.  Is that true?
    	MR. WAGNER.  I did.  I met with infectious disease professionals in a
    number of the hospitals throughout the State of Missouri during the
    course of this legislation.  We included them in the drafting of the
    legislation.  The bill itself went through some 10 different revisions.  The
    medical association came on board and assembled a team of medical
    doctors to look at it as well.  It was important to me that the legislative
    process be inclusive of the professionals and that they had a buy into this,
    and we took advantage of their expertise.
    	The legislation also established an advisory committee which
    consisted of, I believe, eight medical professionals in addition to a couple
    of consumer representatives, and so there is ongoing inclusion of
    professionals in the drafting of the regulations.
    	MR. WHITFIELD.  And you said that the Missouri Hospital
    Association worked with you closely as you formulated this legislation?
    	MR. WAGNER.  The Missouri Hospital Association did work with us,
    and that was very fortunate.  We started out this effort without including
    them.  As I developed the legislation and worked with the Consumers
    Union, began to look at what had happened in other States--Illinois,
    Pennsylvania was looking at the time--I began to talk to sponsors and
    built the legislative support.  Then the Hospital Association got on board
    and really helped to craft what I think ended up being a fine bill.
    	MR. WHITFIELD.  Now, what were the major obstacles as you moved
    forward in passing this legislation?  What concerns were raised about
    why we should not pass this kind of legislation?
    	MR. WAGNER.  Well, there were a number of obstacles, and not all
    of them were addressed in legislation.  There is a process where we
    continue to develop regulations with the legislation, but certainly
    Missouri has several teaching hospitals, and teaching hospitals have a
    different patient base and a different experience level than non-teaching
    hospitals.  Missouri has several urban communities, St. Louis, Kansas
    City, Springfield, and then there are rural hospitals, and that presents
    issues.
    	And then there were concerns about the issue of risk-adjusted data
    which needed to be addressed, and was addressed to a large degree.  The
    issue of the different practices in collecting statistics was one that came
    up and we attempted to deal with that.  Some hospitals that were more
    meticulous about collecting their data might look less favorable than
    those who were not as meticulous.  So these were a number of the
    hurdles that we needed to address, and then of course the basic science,
    the statistical gathering, how to report it to the public, these were all
    issues that we dealt with.  We worked closely with the Department of
    Health, the experts, who collaborated with the CDC, incorporated
    reliance upon the CDC into the legislation as well.
    	MR. WHITFIELD.  I am assuming that as you became involved in this,
    you looked into some other States to see what legislation they had
    adopted.  What States did you look to?
    	MR. WAGNER.  Yes, Mr. Chairman, at the time Illinois had just
    passed legislation and that became a good starting point.  Pennsylvania
    had adopted legislation.  New York was considering legislation.  Then I
    looked to a number of the reporting regulations in Missouri already.
    Missouri, like I am sure many States, requires extensive reporting from
    hospitals to the Department of Health, everything from child abuse to
    certain animal bites to rabies to venereal diseases.  We are even required
    to report--it is slipping my mind right now.  But in any event, we wanted
    to take some of these regulations and incorporate them into the statute as
    well.
    	MR. WHITFIELD.  Now, in the healthcare field today, particularly
    with all of the litigation that is going on and people are always concerned
    about gigantic judgments against them, I am assuming, were there
    concerns on the part of the hospital about plaintiff lawyers using this
    kind of information to file more lawsuits against them?
    	MR. WAGNER.  There was concern on the part of the hospitals about
    that.  That was a concern that I personally am very sensitive about in my
    role with my own company and being aware of the litigious society that
    we live in today.  And so we included a provision in the Missouri bill
    that stated plainly that none of the reports created by the Department of
    Health would create any sort of standards for purposes of any litigation.
    And after having vetted that through the hospital's attorneys and the
    attorneys for the various groups that were working with us, we felt
    comfortable that that would insulate the hospitals and provide the
    information, because the goal was to get the information out.  I made it
    very plain that I wanted it to be lawsuit neutral, neither to enhance
    anybody's capacity to sue or impair anybody's capacity to sue.
    	MR. WHITFIELD.  And in the other States that you looked at, do they
    have that same kind of provision?
    	MR. WAGNER.  I do not believe so, Mr. Chairman.  I don't know, but
    I don't recall seeing any at the time.  I have not studied a number of the
    pending bills you mentioned.  There are 20 to 30 pending in other States.
    I have looked at a number of these.  I would suspect by now it has been
    included in some because it is a real concern that has to be dealt with.  I
    did not want to put any sort of chilling effect on the hospitals.
    	MR. WHITFIELD.  And what day was the Missouri law signed into
    effect?
    	MR. WAGNER.  It was signed I believe June 28 of 2004.
    	MR. WHITFIELD.  And what has the effect of that law been?
    	MR. WAGNER.  Well, at this particular moment, the bill is still being
    implemented.  We established effective dates that were fairly well-
    distanced into the future so that the Department of Health and Senior
    Services would have sufficient time to collaborate with CDC and other
    organizations to develop the appropriate regulations.  So we established
    that the first report would be published on December 31 of 2006.  The
    data has just started coming in as of the first part of this year.  We
    categorized different types of infections.  We focused on Class I type
    surgeries because we thought those would be least likely to be tainted,
    and that information is now just starting to roll in.  It will be coming in in
    quarters and the reports will be published in 12-month rolling
    increments, commencing December 31, 2006.
    	MR. WHITFIELD.  Now your son did not have a complicated fracture,
    per se, was it?  I mean, he did not have the skin punctured or anything
    like that?
    	MR. WAGNER.  He did not have his skin punctured, which had his
    skin been punctured, the circumstances might have been different.  It
    might be more understandable that he had an infection because he might
    have acquired it in the community, but he arrived in the hospital with
    certainly a fractured humerus bone at the elbow, and he required surgery
    and manipulation of the bones and a couple of pins, but the skin was
    unbroken when he arrived in the hospital.  The infection appeared at the
    site of the surgery.
    	MR. WHITFIELD.  Mr. Wagner, my time is expired.  Thank you.
    	I recognize Mr. Stupak for 10 minutes.
    	MR. STUPAK.  Thank you, and thank you, Mr. Wagner, for appearing
    here today.
    	Knowing what you know now about the causes of hospital-acquired
    infections and the specific steps that can be taken to prevent them, do
    you think that public reporting is sufficient to stop it?
    	MR. WAGNER.  I don't think public reporting alone, Congressman, is
    sufficient.  It is a step.  It is one of the arrows in the quiver, if you will.  I
    think there needs to be standardized training, I think there needs to be a
    very conscious level of attention to hospital practices, processes have to
    be streamlined and focused upon in connection with infectious disease.
    	Reporting, I think, will be an important step.  It will certainly give
    consumers a tool.  It will help to establish best practices.  No hospital is
    going to want to see their numbers look inferior compared to other
    hospitals in the community, so they are going to raise their own
    standards and so on, but it is not the total solution, no, sir.
    	MR. STUPAK.  Well, I missed part of your testimony because I had to
    meet with some other folks here, but does the Missouri bill do anything
    other than public reporting?
    	MR. WAGNER.  The Missouri bill does do other things besides public
    reporting.  It requires hospitals to establish a monitoring practice of their
    own internal infectious disease procedures, some of which is done when-
    -
    	MR. STUPAK.  Infectious disease or through infectious medical
    procedures which lead to--like we know intravenous--
    	MR. WAGNER.  They are required to monitor their own procedures
    aimed at reducing infections and infectious diseases they implement to
    ensure precautions so that the patients don't get the--
    	MR. STUPAK.  Well, has the Missouri Hospital Association done
    anything to try--much like we did in Michigan, much like the Keystone
    where you actually put forth practices to reduce infections?
    	See, my concern is I would think that a consumer, it would be more
    important not to know what the infection rate is, but what is the hospital
    doing to reduce the infections?
    	MR. WAGNER.  Yes.  Well, certainly the Department of Health is
    preparing guidance and brochures on the legislation.  Information has
    been provided to hospitals and to patients as to how to handle their stay
    in a hospital.  Comment cards are made available to the patients under
    the legislation.  There is a provision which encourages hospital staff to
    report violations or practices that would be susceptible to infections, and
    they would be protected from any sort of retaliation.
    	MR. STUPAK.  So have the infection rates gone down?  It has been
    less than two years since this bill has been signed, I think you said it was
    June 28, 2004.  Have you seen any change in infection rates in Missouri,
    or is it more just the reporting of infection rates?
    	MR. WAGNER.  At this point, sir, I could not quantify or could not
    give an opinion as to whether or not the infection rate has gone down.
    The first report has not yet come out.  The law is still in the
    implementation phase.
    	Now to the extent that public awareness has increased, this
    legislation and the regulations and the procedures have received
    widespread attention throughout the State of Missouri, and consumers, I
    think we have had the deaths of a couple of prominent individuals in the
    State.  A county executive for St. Louis County died of a staph infection;
    one of our former coaches for the Rams and broadcasters recently passed
    away, and so on, so attention has been focused on this and that has
    perhaps had a positive impact, but I would not be able to articulate any
    quantifiable data at this point.
    	MR. STUPAK.  You indicate in questions from the Chairman that the
    legislation in Missouri--and you took great pains to make it lawsuit
    neutral.  How about terminology neutral for the average consumer,
    because in preparing for the hearing here, CDC uses the word, and
    hopefully I am saying it right, nosocomial infection--
    	MR. WAGNER.  Nosocomial.
    	MR. STUPAK.  The average person doesn't know what the heck that
    is, so I would hope that Missouri law, besides worrying about litigation,
    would also have legislation that would break down these words so the
    consumer could understand it.
    	MR. WAGNER.  That is a very fair point, and I will make a point to
    raise that at our next advisory meeting as we continue to develop what
    the website will look like and the information we put forward.  The bill
    itself, we named it "The Nosocomial Act of 2004," reduction act, I
    believe.
    	Largely, we--and again, in an interest to getting the hospitals to work
    with us, we avoided the term hospital-acquired infection to appear to be
    disparaging in any way to the hospitals, so we used a more technical
    term.
    	MR. STUPAK.  Yeah, but then you probably lost the consumers.
    Nosocomial Legislation Act of 2004, that doesn't really warm my heart
    or do anything to really get me focused on the issue.
    	MR. WAGNER.  Well, my hope or my expectation is that consumers
    are not going to be aware of the law, per se, they are going to be aware of
    the result between the hospital administrators.  For example, when I took
    my son to a hospital, we appeared at one hospital, I talked to the doctor
    and I asked him if he was the best doctor to do this surgery.
    	MR. STUPAK.  Right.
    	MR. WAGNER.  He said there was another hospital down the road
    that did more surgeries on elbows, so I consulted with my pediatrician,
    and we put our son in an ambulance and sent him down the road.  If this
    law were in effect, I would trust that my pediatrician would be aware of
    the technicalities and be aware of the reports and might have said to me,
    you know, Ray, you are better off staying where you are with Raymond
    as opposed to going down the road, and so on and so forth.
    	So I think between consumers and also the doctors, that it should
    have a positive impact.
    	MR. STUPAK.  Sure, but the best surgeon for your son's case may not
    have had privileges at the hospital with the lowest infection rates, if that
    was all you are basing it upon.
    	MR. WAGNER.  But at least at that point, Congressman, I would have
    been able to ask myself, am I willing to trade an environment where
    maybe he does not have the best surgeon, but they have a lower
    likelihood that he is going to be infected with a staph infection or an
    MRSA or VRE or some other deadly infection?  At least then I would
    have been able to make a more informed decision.  As it was, I did not
    have that information.  I took him to the hospital down the road, and I
    probably would have been better served to keep him at the original
    hospital, take my chances with the fine doctor who attended to him, even
    though he was less experienced with pediatric children and perhaps had
    less experience with growth plates on the elbows and so on and so forth.
    But my son maybe would not have acquired the infection.
    	MR. STUPAK.  Well before--and I appreciate everything you have
    done to try to bring this to public attention, and also try to lower
    infection rates, but after this whole incident, would you have known
    before all this where to even begin to look on infection rates in the
    hospital?  Was there anything in Missouri which would allow you to
    access any kind of information as to infection rates of certain hospitals
    throughout Missouri?
    	MR. WAGNER.  At the present time, there is no such mechanism.
    There is no opportunity for either consumers directly or their internist, or
    in my case, the pediatrician, to know.  And that, of course, is what gave
    rise to my--
    	MR. STUPAK.  Absolutely.
    	MR. WAGNER.  --interest in doing this.
    	MR. STUPAK.  And there is what, about six States now who are using
    this field of knowledge?
    	MR. WAGNER.  As I understand it, six States that have passed
    legislation and are in the process of implementing reporting.  I think only
    one State so far has produced reports, and in some other 20, I think it is
    closer to 30, States are considering legislation.
    	Each of the bills are slightly different.  They all have a common
    thread, and I think in the course of a few years we should have a pretty
    good sampling of perhaps what works, working in cooperation with the
    professionals here in this hearing room and CDC and the other
    organizations.
    	MR. STUPAK.  Let me ask you one more question.  Mr. Murphy sort
    of alluded to it in his opening statement, and I believe one of the
    witnesses from Pennsylvania is going to testify that if Congress would
    crack down and not pay Medicare or Medicaid payments to a hospital if
    the Medicare or Medicaid patient had an infection as sort of a way to
    financially bring about a change in infection rates, do you think that
    would be an appropriate approach?
    	MR. WAGNER.  I think it is an approach which could and should be
    discussed.  It is certainly an approach, as I listen to those remarks, that I
    thought about is done with highway dollars and considerable public
    policy, I think, is established tied to highway funding and so on and so
    forth.  So I think it is something that could provide the additional
    incentive for States to take the steps within those States, working with
    CDC to come up with the right formula.
    	In the Missouri bill, another provision did direct that a hospital
    receiving any State funding not receive some or all of that State funding
    if it is not implementing and complying with the mandates of the law,
    and I suspect that will have a positive impact.
    	MR. STUPAK.  Two quick questions.  There are probably some
    infections we can't anticipate or get control of, so how do you separate
    those from the preventable?  Secondly, did Missouri law put in any
    financial incentives to help the hospitals develop an infection prevention
    program?
    	MR. WAGNER.  On your first question, there is no doubt in my mind
    that there are infections which are not going to be stopped no matter
    what is done by way of regulations or laws or anything else, and
    certainly--
    	MR. STUPAK.  Do you know a percentage?
    	MR. WAGNER.  I don't.
    	MR. STUPAK.  Three percent, five percent?
    	MR. WAGNER.  I suspect it is probably--certainly you should ask one
    of the other professionals--double digits.  I am confident, but those
    infections which are preventable through attention to details such as hand
    washing, the isolation--I can go on and on and on--I think are going to be
    significant and substantial and are going to reduce those 90,000 people
    that die, and that was a statistic compiled in the '90s, it is probably more
    today.  It is going to reduce that substantially, but there are going to be
    infections acquired in a community that are brought into the home,
    infections that cannot be stopped no matter what.
    	My hope, at least when comparing hospital to hospital, that those
    statistics will wash in the end and there will be, over time, we will be
    able to see a fluctuation in the infections which can be managed and
    controlled.
    	You asked secondly if there were any financial incentives.  There
    were no financial incentives.  There was money allocated even before the
    bill was passed, which was sort of a statement from the legislature about
    how strongly it felt to implement the bill and to take the steps to develop
    the computer system.
    	MR. STUPAK.  Thanks for your time and testimony.
    	MR. WAGNER.  Thank you very much.
    	MR. WHITFIELD.  The gentleman from Texas, Dr. Burgess is
    recognized for 10 minutes.
    	MR. BURGESS.  Thank you, Mr. Chairman, and Mr. Wagner, thank
    you for being here and sharing what I am sure is sometimes a difficult
    story to relate.
    	Can you help us just a little bit?  I know you abbreviated this in your
    testimony for the sake of time, but go through the timeline with us a little
    bit about the day the injury occurred.  Your child was taken to the first
    hospital and received a diagnosis, diagnostic x-rays in the emergency
    room at that hospital?
    	MR. WAGNER.  On December 24, 2002, Christmas Eve--
    	MR. BURGESS.  Christmas Eve, approximately what period of time
    did you spend in the first hospital?
    	MR. WAGNER.  We took him into the first hospital--I drove him there
    through the snow.  The x-rays were taken, he was given some shots of, I
    believe, morphine in his arm.  His coat was cut off of him, and within the
    hour or so, we had the x-rays.  I was consulting with the orthopedic
    surgeon on call and at the same time, I had reached out to his pediatrician
    by phone and we had gone through the process where I summoned up
    some of the nerviness within me to ask the doctor if he was the
    appropriate doctor to be doing this surgery.  The bone was crossways in
    the elbow.  It was in three or four pieces--
    	MR. BURGESS.  And it involved the growth plate?
    	MR. WAGNER.  I was concerned of the growth plate.  So we had him
    on the ambulance to hospital number two probably 2-1/2 hours after he
    entered hospital number one.
    	MR. BURGESS.  And then the surgery took place?
    	MR. WAGNER.  The surgery took place a couple of hours later.  We
    arrived at the first hospital about 3:00 in the afternoon, when I should
    have been arriving at my in-law's home, and then the surgery
    commenced around 9:00 and interestingly, I knew the surgeon who
    performed the surgery, a college friend of mine.  I knew many of the
    nurses and people there in the hospital.  The surgery was completed
    around 10:30, 11:00, the doctor came to see me.  Then Raymond was in
    the hospital, I stayed in the hospital, his mother as well, the two of us
    were there, and we brought him home, I believe around 8:00 in the
    morning or so, the following morning.
    	MR. BURGESS.  To the best of your knowledge, were any antibiotics
    administered during the hospitalization, during the surgery?
    	MR. WAGNER.  I don't know, sir.
    	MR. BURGESS.  Neither do I know whether that would be a common
    practice.  I was just wondering.
    	MR. WAGNER.  I know nowadays through my involvement in this
    project, this cause, that that is something that should receive, perhaps,
    more attention.
    	MR. BURGESS.  Certainly, if Dr. Murphy gets his way and they get
    punished by Medicare, yeah, that's a dissance.  They will get the
    antibiotics with the surgery.
    	But in any case, then how many days later was it that the infection
    cropped up, the symptoms of infection?
    	MR. WAGNER.  He probably acquired a fever within a day or so of
    being home, and we called the doctor and the hospital.  And they said
    well, this is normal given the trauma that he has been through with the
    elbow.  And we called back the next day and at some point, he was
    administered an antibiotic at that point that we picked up, again, without
    having seen the infection.  Then we brought him into the hospital and
    they looked at the dressing and so on and so forth, and then we were
    back and forth to the doctor a couple of times.  The infection didn't go
    away and it was actually I believe his dentist that said, you know, you
    need to get him into the hospital and you need to get him in there now.
    We went, and that is when he was received and--
    	MR. BURGESS.  So the first antibiotics would have been about three
    days after surgery on oral antibiotics?
    	MR. WAGNER.  I believe that is correct.  I could certainly check.  I
    have copies of his records.  I could be more specific if you like.
    	MR. BURGESS.  I have got to say, it is very commendable that you
    thought enough to ask the doctor if he was the right guy to do the
    surgery.  I don't know that I would have, even as someone who has some
    experience in the healthcare field, I don't know whether I would have
    had the knowledge to ask that question.
    	Do you think, if this were to happen and that law already was on the
    books, do you think you would have asked about the hospital's infection
    rate?
    	MR. WAGNER.  You know, that is an excellent question and I have
    asked myself that in my mind, and there is a very good chance that I
    would not have known the law was on the books, or that that information
    would be available to me.  But that is okay because one, I consulted with
    the pediatrician and I am confident that she would have known about it
    and she would have a sense for which hospitals in the community are
    more prone to infections over other ones, and she would be able to say to
    me, you know, Ray, again, you ought to go down to this hospital or that
    hospital, or stay away from this hospital.
    	And then, I think even more importantly, the hospitals would know
    that the report is there, and they would be tracking it and they would be
    comparing themselves with other hospitals in the community, and they
    would establish best practices--
    	MR. BURGESS.  Let me interrupt you there, because--and it has been
    a few years since I have been in the hospital.  But I seem to recall us
    talking about things like infection rates pretty regularly in hospital board
    meetings and executive committee meetings.  So I guess part of the
    statement that I would question is would your pediatrician have know?
    Perhaps this was information that was already available, but maybe not
    information that was monitored by a non-surgical specialist, by a
    pediatrician.  I mean, I think if I knew that in my primary hospital, we
    have got a problem with MRSA, I am going to think twice before going
    to the operating room.  Because none of us want from the patients family
    to be sure, but you know, as a physician you don't want to have to go
    through this type of ordeal.  Do we know anything about the infection
    rate at either of the two hospitals you were in that night, the first hospital
    or the secondary receiving hospital?
    	MR. WAGNER.  Congressman, no, I don't know anything about the
    infection rates, which of course, was the origin for me wondering why
    that was, and why I didn't know that or why it would not be available.
    	But, if I might just quickly go back to your first observation about
    internal infection and the discussion you had when you were on staff and
    the attention that hospitals give.  All hospitals do give attention to their
    own infection rates.  I have become very clear on that point.  Many of
    them have infectious disease departments and monitor this sort of thing.
    The problem is they don't share it with anybody else, and they don't
    share it, then you don't have any comparisons about one hospital to the
    next, and each of them, I've come to understand, has their own
    constraints in terms of resources and what level of attention those
    infection rates get.  I have seen in some of the most prominent hospitals
    in Missouri their graphs and their charts of how they track this stuff
    internally.  The problem is something is lost in the translation from that
    internal observation and attention as compared to the next one, in my
    opinion.  That is part of the paralysis that I believe I--
    	MR. BURGESS.  I will tell you thee is a pretty prolific grapevine in
    the hospital, just among doctors and nurses.  If there is a problem,
    generally at least doctors who use the operating room are aware of that,
    but that information also is, as I recall, the Joint Commission for
    Accreditation of Hospitals, at least in Texas, that is information that they
    are interested in, infection rates and MRSA rates.
    	I guess I would just wonder if that is not something that is known at
    some point along the line, but that information was never shared with
    you.
    	MR. WAGNER.  It certainly was not shared with me, and from all my
    involvement in Missouri with the hospitals, the doctors, the Department
    of Health and so on and so forth, I don't believe that there is
    comprehensive infectious disease information made available to the
    Department of Health, and certainly, is it not made available to patients.
    	What can be obtained and what was obtained during the course of
    legislative activities were how many people on death certificates where it
    was noted that people died of, you know, infections, MRSA, VRE, and
    so on and so forth.  But that certainly is not a sample.
    	MR. BURGESS.  But, you know, just listening to your story, too, it is
    also possible that the collitization with the staph occurred in the x-ray
    department in the first hospital, and the second hospital may have had an
    absolutely clean infection rate until your son's case.  So that can be
    information that might be helpful.
    	One of the things that I do want us to think about, and in this county,
    where people are generally healthy, have high health literacy, and can
    stay away from those neighborhoods where infection rates might be
    expected to be higher than the foreign neighborhoods.  If we are not
    careful about how we construct this, we should be very careful to make it
    a positive reinforcement and not a negative reinforcement, and Mr.
    Chairman, you have been very indulgent.  I will yield back.
    	MR. WAGNER.  Thank you, Doctor, and I completely agree with your
    last comment as well.  That is hopefully where some of the risk
    adjustment will come into play.
    	MR. WHITFIELD.  Mr. Inslee is recognized for 10 minutes.
    	MR. INSLEE.  Thank you, Mr. Wagner, thank you for being here.  I
    want to ask you kind of a hard question, and I appreciate your being here.
    You are Vice President at Enterprise rental cars?
    	MR. WAGNER.  Right.
    	MR. INSLEE.  One of the hard things of our job is figuring out when a
    regulatory scheme is appropriate, because regulatory screening equals
    cost on business.  There are truths of the time which are tough to deal
    with, businesses normally sort of reject regulatory schemes.
    	In this case, you have suggested this effort to make sure that
    consumers are aware of disparate results by different hospitals.  Let us
    say that someone suggested in the rental car industry, rental car
    companies are to disclose their fatalities per mile or your fatalities per
    accident or something so that the consumer can make decisions.  I
    suspect if someone proposed that, good-hearted people around the car
    industry would say well, we have different customer bases.  It is hard to
    compare apples with oranges.  There is no proven record that this
    recordkeeping will really advance safety, that kind of thing.
    	I just wonder if you could give us your thoughts on why it is
    appropriate in this context in a hospital situation to give the consumer
    this information, this sort of compiled data, given where not maybe other
    industries in other contexts even involving safety issues.
    	MR. WAGNER.  Thank you for that question, Congressman, and I
    don't particularly find that to be a hard question as perhaps you
    suggested.  I think coming from representing corporations, I certainly
    understand the perspective that less regulation is better, and corporations
    certainly pursue that, and I do on behalf of my company from time to
    time.  But I think when it comes to protecting the sickest among us, the
    people that use our hospitals, I think that is a very legitimate place for
    government to interject itself and to perhaps establish parameters and
    even a regulatory scheme, if possible.  Particularly if the regulated, if you
    will, the hospitals, the medical community are not doing everything that
    they can on their own to address the situation.
    	I think during the course of the Missouri legislation, there were
    just a few people along the road that scratched their head and said, you know,
    Ray, how do you find yourself in this position?  And I found myself with
    new partners that I did not have before, but at the end of the day, the bill
    passed unanimously in the State of Missouri, save one vote in the House
    of Representatives.  All Republicans, 100 percent of them signed on to
    the bill or voted for it, and nearly all Democrat members of the
    legislature.  It was viewed as, certainly, a pro-consumer, pro-patient bill
    that we talked about, and it was viewed as a pro-business bill.  I was
    somewhat embarrassed throughout the course of this every time that I
    explained to my employer that I was going back into the hospital for my
    son, that my employer was picking up the expenses of all of these costs,
    except the countless deductibles, co-pays, and so on and so forth, out-of-
    network expenditures that I had, but it was a tremendous cost burden on
    employers, from a time standpoint away from my day-to-day
    responsibilities, the costs that went into this, I don't know what they are.
    At one point, I got a little bit of a look at them.  I am sure they are well
    over $100,000 that was factored into the base that led to the following
    year's co-pays and deductibles and benefits provided to all my
    colleagues.  And so it was very much a pro-business bill in concept as
    well.
    	MR. INSLEE.  Did you consider more vigorous efforts to require
    specific anti-infection protocols or, for instance, one of our witnesses
    later today will suggest that if Medicare would stop paying for infections
    that exceed a certain rate, that that would be an incentive that would be
    more effective than this one of public information.  Did you consider that
    or do you have any comments about those ideas?
    	MR. WAGNER.  We did not consider any sort of punitive or incentive
    steps like that.  We wanted to ensure that the legislation was manageable.
    We articulated particular types of surgeries and then as we became more
    adept at particular types of procedures as a State would, the Department,
    then others could be added by regulations.  So the only punitive measure
    that is in there is the withholding of State funds if a hospital's funds that
    are otherwise provided to a hospital, if a hospital is not complying with
    the legislation.  And then the public reporting speaks for itself, and some
    of the other monitoring provisions and so on and so forth could be dealt
    with during the course of licensure of each of the facilities on an annual
    basis.
    	So there are those ramifications, but there was, at this point in
    time, and from what I understand in my conversations with the Department of
    Health and through my involvement on the advisory committee, I was
    appointed to be a consumer representative on this advisory committee.
    The procedures, the data collection, the statistical methodology that has
    been put forward for them to use is being well received and the
    information is coming in.
    	MR. INSLEE.  Thank you.  I will ask you privately how you get your
    son of that age to wear a tie later.
    	Thank you very much.
    	MR. WHITFIELD.  Well, Mr. Wagner, we genuinely appreciate your
    being here today, and your testimony was quite helpful to us.  I think
    everyone has completed their questions, so you are dismissed and we
    wish you the very best.  Tell your son we appreciate him testifying as
    well.
    	MR. WAGNER.  Thank you, Mr. Chairman, thank you, members of
    the committee.  It was a pleasure to be here.  Thank you for looking at
    this issue.
    	MR. WHITFIELD.  At this time, I will call the second panel which
    consists of one person, and that is Dr. Denise Cardo, who is the Chief of
    the Division of Healthcare Quality Promotion at the Centers for Disease
    Control and Prevention in the U.S. Department of Health and Human
    Services.  Dr. Cardo, we welcome you and we look forward to your
    testimony.
    	As you are aware, this is an investigatory hearing, and it is our
    policy at these hearings to have our witnesses testify under oath.  Do you
    have any difficulty with testifying under oath today?
    	DR. CARDO.  No.
    	MR. WHITFIELD.  And I assume you do not have a lawyer either?
    	DR. CARDO.  No.
    	MR. WHITFIELD.  So if you would stand.
    	[Witness sworn.]
    	MR. WHITFIELD.  Thank you.  You are under oath, Dr. Cardo, and
    we would welcome you to give your 5-minute opening statement.

                STATEMENT OF DR. DENISE CARDO, CHIEF, DIVISION OF
                    HEALTHCARE QUALITY PROMOTION, CENTERS FOR
                        DISEASE CONTROL AND PREVENTION, U.S.
                     DEPARTMENT OF HEALTH AND HUMAN SERVICES

    	DR. CARDO.  Good afternoon, Mr. Chairman and members of the
    subcommittee.  I am Dr. Denise Cardo, Director of the Division of
    Healthcare Quality Promotion at the Centers for Disease Control and
    Prevention, CDC.  I am pleased to be here today to describe the activities
    the CDC has undertaken in monitoring and preventing healthcare-
    associated infections.
    	CDC provides leadership in surveillance, outbreak investigations,
    laboratory research, and prevention of healthcare-associated infections.
    CDC is committed to protecting the Nation's health and helping all
    Americans receive the best and safest care when they go to a hospital or
    other healthcare facility.
    	Healthcare-associated infections are infections that patients acquire
    during the course of receiving medical treatment for other conditions.
    These infections are a threat to patient safety.  Based on 2002 data, CDC
    estimates that each year, there are approximately 1.7 million healthcare-
    associated infections in U.S. hospitals, with 99,000 associated deaths.
    	An increase in public awareness of this severe problem has led to a
    call for public disclosure of healthcare infection rates in the United States
    through mandatory reporting.  Information about healthcare-associated
    infections can lead to an increased focus on infection control and
    prevention.  CDC's experience has shown that sharing information for
    local action can prevent infections and improve patient safety.
    	Educating clinicians, decision-makers, and the public about the
    prevention of healthcare-associated infections is an important benefit of
    the dialogue created by the public reporting movement.  Through
    voluntary reporting from a national network of sentinel hospitals, CDC
    has monitored healthcare-associated infections since 1970, using the
    surveillance methods of the National Nosocomial Infections Surveillance
    System, also known as NNIS.  This systematic collection and analysis of
    data on healthcare-associated infections has provided critical information
    to improve infection prevention and control.
    	The purpose of surveillance is not simply to count and characterize
    infections, but most importantly, to control and prevent them.  Hospitals
    that participated in the NNIS system have reduced rates of infections.
    For example, the rates of bloodstream infections for vascular catheters,
    known as central lines, decreased during the period of 1990 to 2004, as
    you can see here in the graphic.
    	Working with a group of hospitals participating in the Pittsburgh
    Regional Healthcare Initiative, also using NNIS, we demonstrated that
    these infections could be reduced even more.  This collaboration resulted
    in a 68 percent reduction in the rate of bloodstream infections during
    2001 and 2004, as you can see here in this graphic.
    	This experience highlights the importance of regional data for local
    action to prevent healthcare-associated infections.  It also underscores the
    confidence participants had in the NNIS standards that allow fair
    comparisons among facilities.
    	CDC has developed a web-based surveillance system called the
    National Healthcare Safety Network, or NHSN, to replace NNIS.  This
    system provides the ability for facilities to analyze their own data and to
    tailor their infections to meet their greatest needs.  As a result of CDC's
    discussions with States, technical enhancements of NHSN are planned to
    better support public reporting.
    	In February 2005, the Healthcare Infection Control Practices
    Advisory Committee, in collaboration with CDC and professional
    organizations, published guidance for public reporting of healthcare-
    associated infections.  This document includes recommendations to
    States considering legislation for mandatory reporting of healthcare-
    associated infections, and also highlights strategies to avoid potential
    unintended consequences.
    	CDC supports national standards as a key to consistency in case
    finding, data collection, trend analysis, risk adjustments, and
    comparisons across surveillance sites and jurisdictions.  CDC also
    supports the use of electronic data for surveillance as a way to streamline
    case detection and reporting.
    	In conclusion, healthcare-associated infections are a threat to patient
    safety.  While many organizations are working hard to prevent infections
    in U.S. hospitals, this issue continues to be a challenge and more needs to
    be done.  Public reporting of healthcare-associated infections can be a
    tool for increased adherence to recommendations.  Individuals at the
    Federal, State, and local levels in the public and private sectors need to
    work together to improve strategies to meet this healthcare challenge.
    CDC is strategically positioned to continue to provide leadership in this
    area.
    	Thank you very much for your attention, and I will be happy to
    answer any questions you may have.
    	[The prepared statement of Dr. Denise Cardo follows:]

    PREPARED STATEMENT OF DR. DENISE CARDO, CHIEF, DIVISION OF HEALTHCARE QUALITY
      PROMOTION, CENTERS FOR DISEASE CONTROL AND PREVENTION, U.S. DEPARTMENT OF
                             HEALTH AND HUMAN SERVICES

            Good afternoon Mr. Chairman and Members of the Subcommittee. I am
    Dr. Denise Cardo, Director of the Division of Healthcare Quality Promotion
    of the National Center for Infectious Diseases, Centers for Disease Control
    and Prevention (CDC).  I am pleased to be here today to describe the
    activities CDC has undertaken in monitoring and preventing healthcare-associated infections. CDC provides leadership in surveillance, outbreak
    investigations, laboratory research, and prevention of healthcare-associated
    infections. Knowledge gained through these activities is used by CDC to 1)
    assess the magnitude, trends, and risk factors of healthcare-associated
    infections; 2) detect new patterns and mechanisms of antimicrobial resistance;
    3) detect infections and adverse events related to new procedures performed
    in healthcare; and 4) develop new strategies to prevent healthcare-associated
    infections.

    Healthcare-associated Infections:  The Hidden Harm of Healthcare
            As the nation's health protection agency, CDC is committed to
    helping all Americans receive the best and safest care when they are treated
    at a hospital or other healthcare facility. CDC has defined twenty-one
    specific health protection goals to prioritize and focus its work and
    investments and measure progress. Our Division has been designated as the
    lead for the goals to increase the number of healthcare settings that
    provide safe, effective, and satisfying patient care. Healthcare-associated
    infections are infections that patients acquire during the course of receiving
    medical treatment for other conditions; these infections are a threat to
    patient safety. An increasing public awareness of this serious problem has
    led to a call for public disclosure of healthcare infection rates
    in the United States through mandatory reporting of information related to
    healthcare-associated infections.
            Healthcare-associated infections in the hospital are among the most
    common adverse events in healthcare. CDC estimates there are approximately
    1.7 million healthcare-associated infections in U.S. hospitals and 99,000
    associated deaths each year. There are approximately 4.5 infections per 100
    hospital admissions, 9.3 infections per 1000 patient days in Intensive Care
    Units (ICUs), and 2 surgical site infections per 100 operations. These
    estimates are based on best available data, but some infections are
    known to be underreported, so the actual number of healthcare-associated
    infections may be higher.
            Estimates of the economic impact of healthcare-associated infections
    vary because of differences in how the data are defined and analyzed.  Data
    from published studies indicate the estimated cost of healthcare-associated
    infection, adjusted to 2004 dollars, ranges from $10,500 per case for
    bloodstream, urinary tract, and pneumonia infections to $111,000 per case for
    antibiotic-resistant bloodstream infection in transplant patients.

    Who is at Risk for Healthcare-associated Infections?
            Healthcare-associated infections are defined as infections affecting
    patients who receive either medical or surgical treatments. The procedures and
    devices used to treat patients can also place them at increased risk for
    healthcare-associated infections. A patient's skin, the natural protection
    against bacteria entering the blood, is continually compromised by the
    insertion of needles and tubes to deliver life saving medicine. Microbial
    pathogens can be transmitted through tubes and devices that are going into
    patients, providing a pathway into the blood stream and lungs. Because of the
    number of procedures and the seriousness of patient conditions, patients
    treated in the ICU have the highest risk of healthcare-associated infections.
            The frequency of healthcare-associated infections varies by body site.
    In the United States from 1990-2004, the most frequent healthcare-associated
    infections reported to the National Nosocomial Infections Surveillance (NNIS)
    system, overall, were urinary tract infections (34%), followed by surgical
    site infections (17%), bloodstream infections (14%), and pneumonia (13%).

    Bacterial Species Causing Healthcare-associated Infections
            To understand the problem of healthcare-associated infections, it
    is vitally important to recognize the intertwined problem of antimicrobial
    resistance.  Infections that are acquired in hospitals and other healthcare
    settings are frequently caused by bacteria that have become resistant to
    multiple antimicrobial drugs.  These organisms have gained resistance while
    remaining highly infectious and are easily spread in healthcare settings.
    Efforts to prevent healthcare-associated infections must therefore be
    strategically interwoven into efforts that address increasing antimicrobial
    resistance.
            Resistant infections contribute substantially to healthcare costs,
    illness, and death.  Although a number of different bacteria can cause these
    infections, there are a few that cause the majority of diseases.  Of
    particular concern is the bacteria known as methicillin-resistant
    Staphylococcus aureus or MRSA. MRSA was first recognized as a cause of
    healthcare-associated infections in the 1960's and has become commonplace in
    many hospitals in the United States.  According to CDC surveillance, MRSA
    was the cause of 29% of Staphylococcus aureus infections acquired by patients
    in intensive care units in 1991.  By 2003, that number had increased to 60%.
    The number of MRSA infections among hospitalized patients in the United States
    has been estimated to be at least 126,000 per year.  Because of the tremendous
    impact of MRSA and other resistant bacteria as causes of healthcare-associated
    infections, an integrated approach to detection, control, and prevention is
    required and is being recommended by CDC.

    Investigation and Response
            Bacteria and other microbial pathogens causing healthcare-associated
    infections are constantly changing. As new antibiotics are released, the
    organisms find ways to develop resistance. As new devices are used in
    hospitals, the organisms find new or unexpected ways to infect patients.
    The dynamic nature of healthcare-associated infections requires a vigilant
    eye for detecting and responding to these emerging threats.
            CDC serves as a national leader for investigating outbreaks of
    healthcare-associated infections along with state and local health
    departments.  Discussions or calls from concerned clinicians and infection
    control professionals often prompt further investigation.  During
    investigations involving contaminated medical devices or medication, CDC
    works with the Food and Drug Administration to recall contaminated
    devices and medicines if necessary to prevent further infections and save
    patients' lives. For some outbreaks, CDC sends its own epidemiologists,
    physicians, and scientists to hospitals to interview patients and staff, to
    review medical records and to test for microbial contamination of devices or
    of the environment. During investigations, CDC staff interview and gather
    information from patients and family members.  Information
    from these investigations have a direct impact on controlling and preventing
    healthcare-associated infections at these facilities, but also directly lead
    to improvements in national infection control guidelines and in development
    of definitions used for public reporting in those states mandating it.  For
    example, CDC epidemic intelligence service officers were
    recently deployed to North Carolina to investigate increases in reports of
    cases caused by Clostridium difficile, a bacterium that causes over 200,000
    cases of healthcare-associated diarrheal disease each year. Interviews with
    patients and family members are leading to a better understanding of the
    characteristics of the illness and the source of infection. In addition to
    prevention of infections, this information is being used to make practical
    definitions available for use in public reporting for states that are
    considering making Clostridium difficile infection reportable as was recently
    done in Ohio.

    Prevention
            CDC leads and supports a range of infection prevention activities
    at the national, regional and local levels.  CDC's healthcare-associated
    infection prevention activities include developing evidence-based practice
    guidelines, assessing institution- and provider-level barriers and best
    practices for adoption of effective practices, developing and disseminating
    educational materials and toolkits to assist in translating policy into
    practice, and identifying and evaluating novel prevention strategies.
            CDC guidelines serve as the standard of care in U.S. hospitals and
    guide the clinical practices of physicians, nurses and other providers.
    However, full adherence to these recommendations in clinical practice remains
    a challenge. For example, CDC developed and disseminated evidence-based
    guidelines to prevent surgical site infections.   Subsequent assessment of
    adoption of these practices among U.S. surgeons has shown that adherence to
    these recommendations needs to be improved. CDC has successfully
    partnered with the Centers for Medicare and Medicaid Services (CMS), surgical
    societies, and other stakeholders to design and launch a national initiative
    for prevention of surgical site infections.  In addition, CDC guidelines have
    served as the basis for national healthcare quality initiatives such as the
    Institute for Healthcare Improvement's 100,000 Lives Campaign, and the
    Surgical Care Improvement Project.  These collaborations help to standardize
    clinical practice, translate policy into practice, and reduce healthcare-associated infections.

    Monitoring Infections
            Through voluntary reporting from a national network of sentinel
    hospitals, CDC has monitored healthcare-associated infections since 1970
    using the surveillance methods of the NNIS system.  With these data, CDC has
    provided hospitals nationwide with infection rates that they use to track
    their progress in prevention and control efforts.
            More than just a reporting mechanism, NNIS has set standards that
    have been used by hospitals and healthcare researchers internationally to
    measure healthcare-associated infections and to document progress with
    adherence to infection control practices. Standard definitions for
    surveillance and standard approaches to data collection and analysis have
    allowed clinicians and hospital staff to gauge how well they are preventing
    infectious disease outcomes such as bloodstream infections, pneumonias,
    urinary tract infections, and surgical site infections. Because hospitals
    may have very different kinds of patients, rates of healthcare-associated
    infections can be calculated to account for differences in severity of
    illness or in the complexity of procedures performed. The use of
    these "risk-adjusted rates" allows facilities to more accurately compare
    their own progress in infection prevention and control to other facilities
    as well as to their own rates in the past.
            The purpose of surveillance is not simply to count and characterize
    healthcare-associated infections, but most importantly to control and prevent
    them. The data are only as good as our ability to improve the quality of
    healthcare and to minimize and eliminate infections. For this reason, CDC
    built into NNIS, and now into the recently launched web-based surveillance
    system called the National Healthcare Safety Network (NHSN), the ability for
    facilities to analyze their own infection data and to tailor their activities
    to meet their greatest needs. This feedback, coupled with quality improvement
    initiatives to increase adherence to CDC infection control practice standards,
    can reduce healthcare-associated infections.

    National Data for Local Action
            The systematic collection and analysis of data on healthcare-associated infections yields critical information that can improve infection
    prevention and control. Hospitals that participated in the NNIS system have
    been successful in reducing rates of specific infection types across the
    spectrum of healthcare-associated infections.  During 1990-2004, rates of
    infections from medical devices decreased for three main body sites: the
    respiratory tract, urinary tract, and bloodstream, which are all monitored
    in ICUs.  Bloodstream infections from tubes or catheters used to monitor
    patients or deliver medicine directly into major blood vessels (central
    lines) decreased substantially over the 14-year period. They decreased by
    54% in medical ICUs, by 43% in coronary ICUs, 43% in surgical ICUs, and 27%
    in pediatric ICUs. For urinary catheter-associated infections, similar
    decreases among these same four ICU types ranged from 43% to 61%. Trends of
    ventilator-associated pneumonia rates were assessed through 2001 and
    substantially decreased from 31% to 58% among these same ICU types.  These
    data are derived from CDC's NNIS and NHSN systems, which have proved to be
    instrumental in initiating change by effectively providing hospitals feedback about their own infection rates resulting in these significant decreases.
            One example of how the system has led to improvement in healthcare-associated infection rates comes from a hospital in New York.  Linda Greene
    is an Infection Control Professional whose 500-bed hospital in New York has
    participated in the NNIS system since 1995.  She states, "We have made
    significant improvements in several areas as a result of being able to
    utilize infection data which is reliable, valid, and risk adjusted.  We
    are then able to turn this data into information which allows care
    providers to improve both the outcomes of care as well as those processes
    most closely associated with these outcomes."  She reports that one specific
    project resulted in a 75% reduction in central line-associated bloodstream
    infections over 2 years resulting in a drop in attributable mortality to
    zero and preventing more than one million dollars in costs.  Their reduction
    has been statistically significant and sustainable.
            At the core of efforts to share prevention solutions is the use of
    healthcare-associated infection data as a common measurement and feedback
    tool. Using a standardized form of measuring healthcare-associated infections,
    such as the kind NNIS and NHSN provide, allows hospitals to communicate with
    one another about the impact of their prevention efforts in a meaningful and
    credible way and spread the word about prevention strategies that work.

    Regional Data for Local Action
            The Pittsburgh Regional Healthcare Initiative includes approximately
    40 healthcare facilities in the Pittsburgh area with the goal of eliminating
    preventable healthcare-associated infections.  Working closely with our
    prevention partners in southwestern Pennsylvania and elsewhere, CDC is using
    NHSN to collect data in standardized ways and collect process measures (e.g.,
    selected practices used during central line insertion, such as correctly
    preparing the skin) and outcome measures (e.g., selected healthcare-associated
    infections such as central line-associated bloodstream infections) in the
    participating hospitals in the Pittsburgh area.  These data and the successful
    prevention methods are shared with clinicians and hospitals. Our work there
    suggests that hospitals are eager for this type of productive sharing of
    regional information. For example, a bloodstream infection prevention
    initiative involved over 70% of the eligible hospitals in Pittsburgh
    metropolitan statistical area, and included a wide range of facilities from
    the very smallest community hospitals to the very largest tertiary care
    facilities.
            This CDC-supported collaboration in Pennsylvania resulted in a 68%
    reduction in the rate of central line-associated bloodstream infections during
    the period April 2001--March 2005, a reduction that is estimated to result in
    at least 40 lives saved every year among the group of intensive care units
    that participated. Strategies perceived as important to this success include
    the involvement of leadership; feedback of unit-, facility-, and region-specific rates of healthcare-associated infections using the NHSN
    system; measurement and feedback of adherence to recommended practices; and
    real-time response to infections.  These experiences with Pittsburgh Regional
    Healthcare Initiative highlight the importance of regional data for local
    action to prevent healthcare-associated infections and underscore the
    confidence participants had in NNIS standards that allowed fair comparisons
    among facilities.  We need standard definitions and data collection tools in
    order to compare, share, and improve practices.  Standardized process
    and outcome measures for national healthcare performance for hospitals,
    nursing homes, and other settings have been endorsed by several agencies and
    organizations, including other U.S. federal agencies and other organizations
    such as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).

    Public Reporting of Healthcare-associated Infections
            An increasing public awareness of the serious problem of
    healthcare-associated infections and the uses of data collection have led to
    a call for public disclosure of healthcare infection rates in the United
    States. Since 2002, seven states have enacted legislation mandating
    hospitals and other healthcare organizations to report healthcare-associated
    infection rates. These states are Florida, Illinois, Missouri, Nevada, New
    York, Pennsylvania, and Virginia.  All but Nevada include a provision for
    public disclosure.  In addition, 22 states have 2006 legislative activity
    underway and six states have bills requiring further study on the issue.
            CDC believes that information about healthcare-associated infections
    can lead to an increased focus on infection control and prevention. In
    addition, CDC experience has shown that sharing information for local action
    can improve patient safety. CDC believes that educating clinicians, decision
    makers, and the public about the prevention of healthcare-associated
    infections is an important benefit of the dialogue created by the
    healthcare-associated infection public reporting movement.
            In order to better guide the states considering legislation for
    mandatory reporting of healthcare-associated infection information, CDC
    partnered with the Healthcare Infection Control Practices Advisory Committee,
    the Council for State and Territorial Epidemiologists, the Association for
    Professionals in Infection Control and Epidemiology (APIC), and the Society
    for Healthcare Epidemiology of America (SHEA) to develop guidance for public
    reporting of healthcare-associated infections.
            These recommendations include 1) to use established public health
    surveillance methods when designing and implementing mandatory
    healthcare-associated infection reporting systems; 2) to create
    multidisciplinary advisory panels, including persons with expertise in the
    prevention and control of healthcare-associated infections, to monitor the
    planning and oversight of public reporting systems for healthcare-associated
    infection; 3) to choose appropriate process and outcome measures based on
    facility type and phase-in measures to allow time for facilities to adapt
    and to permit ongoing evaluation of data validity; and 4) to provide regular
    and confidential feedback of performance data to healthcare providers.  As
    more research and experience becomes available, the recommendations will be
    updated.
            CDC's experience with Pittsburgh Regional Healthcare Initiative and
    other groups indicates that monitoring healthcare-associated infections
    through both process measures and outcome measures is desirable. When deciding
    what should be recommended, the Healthcare Infection Control Practices
    Advisory Committee and partners considered infections with simple definitions
    and existing measurement recommendations by CDC, JCAHO and CMS.
            Over time, any standard will need to be revised when new scientific
    information becomes available and as medical practice evolves. It is clear
    from CDC's experience that a reporting system will produce quality data when
    the infrastructure includes trained infection control personnel, maintenance
    of manual and automated data collection systems and databases, analysis and
    interpretation of findings, creation of evidence-based recommendations, and
    feedback to healthcare professionals to effect change in practices.
            CDC supports national standards as a key to consistency in case
    finding, data collection, trend analysis, risk adjustment, and comparisons
    across surveillance sites and jurisdictions.  As the science of risk
    adjustment advances, CDC will lead the effort to incorporate these advances
    into the system in order to respond better to future national and state needs
    or requests.  CDC also supports use of electronic data for surveillance as
    a way to streamline case detection and reporting, provided the electronic
    data are sufficiently detailed and reliable for those purposes.  The design
    of NHSN will accommodate transmission of data in electronic form from
    hospital  systems to CDC.  As electronic health record systems are more
    widely adopted, NHSN is well positioned to accept electronic data that
    originate in clinical care.
            It has been recognized that with the benefits that public reporting
    may bring, there is also the potential for unintended consequences.  Mandatory
    public reporting that does not incorporate sound surveillance principles and
    reasonable goals may divert resources to reporting infections and collecting
    data for risk adjustment and away from patient care and prevention.  Such
    reporting also could result in unintended disincentives to treat patients at
    higher risk for healthcare-associated infection. Lastly, publicly reported
    healthcare-associated infection rates can mislead stakeholders if inaccurate
    information is disseminated. Therefore, in a mandatory public report of
    healthcare-associated infection information, the limitations of current
    methods should be clearly communicated within the publicly released report.
    Research and evaluation of existing and future healthcare-associated
    infection reporting systems is needed to answer questions about 1) the
    comparative effectiveness and efficiency of public reporting systems and
    2) the occurrence and prevention of unintended consequences. Ongoing
    evaluation of public reporting will be needed to confirm the appropriateness
    of the methods used and the validity of the results.

    Building on NNIS Success - NHSN
            To enhance the potential for public reporting, enable even more
    healthcare facilities to participate in a national surveillance system, and
    use recent advances in information technology, CDC launched the NHSN in 2005.
    NHSN is a secure, Internet-based system that builds on the working
    relationships and surveillance standards established in NNIS.  The system is
    built using standard approaches for information exchange consistent with
    the HHS National Health Information Technology Initiative. Through NHSN,
    participating hospitals can report to CDC and can join a group (e.g., a
    state reporting agency or healthcare system) allowing the agency or
    healthcare system to see their data. Additionally, the data can be entered
    once but can be used for multiple purposes, both for guiding prevention
    programs in the hospital and for public reporting.  This removes parallel,
    redundant data entry.  As a result of CDC's discussions with states about
    NHSN, technical enhancements are planned to better support public reporting.
    CDC is expanding its training and user support for NHSN and is adding
    information technology capacity to handle the anticipated increase in system
    use.
            Virginia now requires the use of NHSN and Missouri recommends that
    NHSN be used for purposes of public reporting. Other states, including New
    York, are considering the use of NHSN. CDC is working with various state
    colleagues regarding the option of using NHSN to meet their needs and to
    define the roles and responsibilities of CDC and state agencies if NHSN is
    selected for use. Wide adoption and adherence to nationally standardized
    infection criteria, data collection protocols, and statistical methods
    enables NHSN to be used more effectively for public reporting across states.
    The ability to compare data produced through a standards-based approach will
    increase the value of healthcare-associated infection reporting for the
    public, policy makers, and practitioners.

    Conclusion
            Healthcare-associated infections are a threat to patient safety.
    While many organizations are working hard to prevent infections and fight
    antimicrobial resistance in U.S. healthcare settings, this issue continues
    to be a challenge.  These problems are larger than any one institution or
    agency can solve alone. Individuals at the federal, state, and local levels,
    in the public and private sector, need to work together to improve strategies
    to meet this healthcare challenge. The information derived from public
    reporting of healthcare-associated infections can be a catalyst for increased
    adherence to recommendations, while steering public and private efforts to
    develop new strategies to prevent healthcare-associated infections. CDC is
    strategically positioned to continue to provide leadership in this area.
            Thank you very much for your attention. I will be happy to answer
    any questions you may have.

            MR. WHITFIELD.  Dr. Cardo, thank you.  And before I ask questions,
    I do want to ask unanimous consent that we introduce this exhibit binder
    into the record, and I believe you all have seen this.  So ordered.
    	[The information follows:]

    	MR. WHITFIELD.  Dr. Cardo, how long have you actually been the
    Chief of Healthcare Quality at the Centers for Disease Control?
    	DR. CARDO.  I have worked in the field of prevention of healthcare-
    associated infections since 1984.  I have been at CDC for 13 years in that
    division, and I have been the director of the division for the last two
    years.
    	MR. WHITFIELD.  So a big part of your career has been devoted to
    preventing infections, I take it?
    	DR. CARDO.  Yes.
    	MR. WHITFIELD.  Just how serious is healthcare-acquired infections
    within the totality of our healthcare system in America today?
    	DR. CARDO.  We know there are several problems in our healthcare
    system, but healthcare-associated infections are a very important
    problem.  And as it was said before, it is a problem that more needs to be
    done in order to prevent more infections.  So it is not just a big problem,
    but a problem that deserves more attention so more action can be done
    and more infections can be prevented.
    	MR. WHITFIELD.  And do you have any way today to determine what
    the, say, hospital-acquired infection rate is in any hospital in the U.S.?  If
    I come to you and I say what are the infection rates for patients
    undergoing surgery at George Washington Hospital in Washington, D.C.,
    can you answer that question?
    	DR. CARDO.  No, I cannot answer that question.  At CDC, we have
    voluntary surveillance system that includes 300 hospitals, most of them
    medium or large-sized hospitals, and we are now in the process of
    expanding that to any healthcare facility in the United States.
    	MR. WHITFIELD.  So--
    	DR. CARDO.  The system has assurance of confidentiality, so as
    CDC, we cannot provide the rate of a specific hospital, but we are
    changing the system in a way that if a State wants to get access to that
    information, it is going to be possible.
    	MR. WHITFIELD.  But you are saying because of Federal laws
    relating to the patient's privacy, that you are prohibited from providing
    information, even if a hospital did have a high infection rate?  Is that
    correct?
    	DR. CARDO.  That is correct.
    	MR. WHITFIELD.  But you are taking steps to change that.  Now, do
    you have the authority to do that from a regulatory standpoint?
    	DR. CARDO.  What we are changing is the way that the information
    can be shared.  So we would not be the one providing that information in
    case you call us, but the hospital can give this authority to other groups,
    like a State.  If we work with Missouri or Virginia and they want to use
    our system so hospitals can report their information, the State can get
    access to that information.  So we are really moving towards a way to
    facilitate sharing that information.
    	MR. WHITFIELD.  But how does it infringe on a patient's right of
    privacy to obtain an infection rate for a hospital if you are not giving any
    information about a particular patient?
    	DR. CARDO.  It is not just a patient's right.  The 308(d) assurance of
    confidentiality gives assurance not just for the patient, but also for the
    hospitals.
    	MR. WHITFIELD.  So the hospital has privacy protection as well?
    	DR. CARDO.  Exactly.
    	MR. WHITFIELD.  And what is the section that provides that
    protection?
    	DR. CARDO.  I remember this.  It is 308(d).
    	MR. WHITFIELD.  308(d), okay.
    	DR. CARDO.  I can provide you more information later if you need.
    	MR. WHITFIELD.  But the NNIS system is the voluntary system, is
    that correct?
    	DR. CARDO.  Correct.
    	MR. WHITFIELD.  But now you are moving to this National
    Healthcare Safety Network?
    	DR. CARDO.  Correct.
    	MR. WHITFIELD.  And what is the difference in those two?
    	DR. CARDO.  The difference is that, as you heard before, things are
    changing and we are learning from that, so it is an improvement of what
    we had before.  It is a web-based system.  It is a system that any
    healthcare facility in the United States can use to collect information on
    infection rates.  We also include information in what is called process,
    that is, how the clinicians are following the recommendations that should
    be used to prevent those infections.  And we are working with the States
    and other healthcare organizations so if they want, they can work with
    their hospitals and they can share the data among those hospitals, like we
    did with Pittsburgh Regional Healthcare Initiative, and finally, we are
    also being ready for the use of the electronic data for hospitals that may
    have that available that could facilitate the detection and monitoring of
    those infections.
    	MR. WHITFIELD.  You know, the testimony that we have heard today
    is that between 1.7 and two million people acquire these infections every
    year, and we have heard figures of 9,000 people dying a year, or 99,000
    people dying a year, which is quite a large figure.  The Centers for
    Disease Control, have you all determined or been able to determine or is
    it your responsibility to determine what is the primary cause of these
    types of infections?
    	DR. CARDO.  In looking at the information that we get from
    hospitals, it is very important, because not only are we determining the
    primary cause of those infections, but also we learn in ways that we can
    prevent those infections, because that is our primary goal.  Our primary
    goal is to prevent those infections.  So we know that the most frequent
    types of infections, like bloodstream infections, urinary tract infections,
    pneumonias, and surgical site infections, and we also know the type of
    bacteria that cause those infections.  So it is not just a way to monitor,
    but a way to learn from that and make a difference in terms of providing
    that information and using information for action in the local levels so
    they can prevent those infections.
    	MR. WHITFIELD.  Do you feel like the time is right for national
    standards relating to this issue, or do you recommend we adopt national
    standards, or do you feel like you are trying to adopt national standards,
    or should we wait for more States to adopt standards?  What should we
    do?
    	DR. CARDO.  The time is now for us to act.
    	MR. WHITFIELD.  The time is now?
    	DR. CARDO.  For us to act and prevent more infections.  I think we
    are ready to respond, and we have started in the way to look at national
    standards.  We still need to learn more in terms of what should be the
    national standards for all hospitals in the United States, especially when
    we consider that most of what we have learned is from large and
    medium-sized hospitals, and there are many hospitals that are small-sized
    hospitals.
    	But this should not be a reason for us not to do anything, and in
    terms of public reporting, HICPAC, CDC, and professional
    organizations, we published a guideline that has been used by States so
    they can start something, and we are also working with the National
    Quality Forum to move towards national standards in the consensus
    process can be used.  But we are working very closely with all the States
    that want to do something about it, so we can at least have some common
    standards or some common language that we are going to follow.  One
    concern is if we start using different definitions and different ways of
    collecting information, in the future it will be very difficult to assess the
    impact of everything that we are doing right now.
    	MR. WHITFIELD.  Now, do you have any enforcement mechanism
    against hospitals at all?
    	DR. CARDO.  We don't.
    	MR. WHITFIELD.  Do not?
    	DR. CARDO.  We do not.  So the way we do, we work with partners
    and we work also with our colleagues in CMS.  We work very closely
    also with the Joint Commission and we work with partners that can do
    things that we cannot.  We don't have any regulatory--
    	MR. WHITFIELD.  So it is all a partnership basis and the Joint
    Commission and so forth?
    	DR. CARDO.  Yes.
    	MR. WHITFIELD.  And do you feel like the partners that you have,
    the groups that you are working with, do they view this as a significant
    issue as well, or do they think that there are other more serious issues
    that they need to deal with?
    	DR. CARDO.  I think the good news is that we are not the only ones
    now who think that it is an important issue.  In the past, it was CDC and
    the professional organizations directly involved in the prevention of
    healthcare-associated infections.  We see that now the partnership has
    expanded.  We have the public, we have the purchasers, and then we also
    have CMS being very involved in the issues, and we are working very
    close together.  We have the Joint Commission, and the fact that we are
    here today and we see so many people talking about the problem and
    how to solve it shows that I think there is a commitment now on several
    levels to make a difference.
    	MR. WHITFIELD.  And do you have a task force that deals explicitly
    with hospital-acquired infections or healthcare-associated infections?
    	DR. CARDO.  Our whole division works with that, and we also have
    an advisory committee that is called HICPAC.  It is an advisory
    committee to the Secretary of HHS and to CDC that has experts as part
    of that committee to help advise and move forward.  In that committee,
    we have, again, the results from all the different partners that are directly
    or indirectly involved in the prevention of infections.
    	MR. WHITFIELD.  Well, my time is expired.  I will recognize Mr.
    Stupak for 10 minutes.
    	MR. STUPAK.  Thank you.
    	Doctor, in your testimony, you refer--and the words have been used a
    lot here today-healthcare-associated infections, yet all of your statistics
    that you refer to refer to infections acquired in hospitals.  So isn't really
    healthcare associated infections misleading and confusing to the public?
    	DR. CARDO.  Thank you for giving me the opportunity to clarify that.
    As you mentioned before, nosocomial was a very confusing word, so we
    tried to move away from that because every time we said we are trying to
    prevent nosocomial infections, people say, what?  So we really saw the
    importance of changing that.  Then hospital-acquired infections was the
    terminology; however, now procedures are not just done in hospitals,
    they are done in healthcare.  So we are seeing similar problems in long-
    term care, ambulatory care, so if you look at the data I provided, I said
    healthcare-associated infections, but in U.S. hospitals--
    	MR. STUPAK.  Right, but are you collecting statistics for the long-
    term care facilities?
    	DR. CARDO.  We are now starting the process of--
    	MR. STUPAK.  So you are just starting?
    	DR. CARDO.  But again, it is not just collecting statistics, but also
    looking at ways to improve prevention of infections in those settings.
    	MR. STUPAK.  Well, let us talk about that because CDC has been
    collecting this information for 35 years, since 1970 you stated, right?
    	DR. CARDO.  Yes, CDC started with a few hospitals.
    	MR. STUPAK.  So for 35 years, and when you are talking about
    national standards, you said the time to act is now.  Then you said, but
    we need to learn more.  So does that mean we are not going to do
    anything?  In response to the Chairman on national standards you said
    the time to act is now, but we need to learn more.  So we don't do
    anything until we learn more?  That is not the way it should go.  It has
    been 35 years.
    	DR. CARDO.  Again, thank you for the opportunity.  Thirty-five years
    of collecting information, that has been extremely important, to even
    define what needs to be done, so groups like were mentioned before,
    Keystone and Pennsylvania, groups that we are working very closely
    with to see how those recommendations can be implemented and prevent
    infections.
    	Today we are focusing on the collection of information, but it is
    really a dynamic process and we work very close in terms of having not
    just collection of data, but recommendations and evaluations so we can
    make a difference.  My reference in terms of we need to learn a little bit
    more is related to the development of national standards, and I think the
    experience we are seeing in some of the States can be very helpful for us
    to learn how to best implement the public reporting.  That is the only
    thing I was referring to.  I am sorry if I misled you.
    	MR. STUPAK.  No, you are not misleading me.  You have been doing
    this for 35 years.  You worked with a small group of hospitals, about 10
    percent of all the hospitals in the United States.  During that time,
    hospital stays have become dramatically shorter, yet infection rates
    continue to go up.  It would appear that CDC's efforts have not been
    very effective beyond the hospitals in your network, which is less than
    10 percent.  I mean, I would think that while you are collecting this
    information, what you just said, you are making recommendations.
    Since hospital stays are shorter, infection rates should be going down,
    but as we see, they are going up.  So while you are collecting
    information, I don't see how you have been effective in reducing it.  And
    I say that respectfully, but everyone is saying this is a national crisis, but
    I don't see where CDC has taken that underneath the same type of
    approach, other than collecting information.
    	DR. CARDO.  Congressman, again, thank you for mentioning that so I
    can clarify that in addition to collecting information, we also have a very
    active program in terms of having recommendations.  Those
    recommendations are the ones that are being implemented in
    Pennsylvania and Keystone, and again, the good news is although at the
    national level, we may not be seeing a lot of progress, we are very happy
    to see that our work on a regional basis with several groups has really
    made a difference in terms of preventing infections.
    	We took the risk a few years ago of working with those in
    Pennsylvania, adopting the elimination of preventable infections, and
    that was very important in terms of showing some of the results you are
    going to--
    	MR. STUPAK.  Sure, they are testifying later, and I will ask them
    about that.
    	But in the Keystone, wasn't that through Johns Hopkins University?
    Keystone was through Johns Hopkins, it wasn't through CDC.
    	DR. CARDO.  The recommendations being used in the Keystone are
    recommendations published in the CDC guidelines and Johns Hopkins--
    	MR. STUPAK.  Did you make these CDC guidelines available to all
    hospitals?
    	DR. CARDO.  Yes, sir.
    	MR. STUPAK.  Okay.  You indicated that you had this website, and I
    think it is called NHSN, right, that was launched in 2005?  It is a secure
    Internet-based system that builds on work relationships and surveillance
    standards developed by the NNIS.  Does the public have a right to access
    that information for public information as to the infection rates of these
    hospitals?
    	DR. CARDO.  The public has the right of assessing in aggregate
    fashion.
    	MR. STUPAK.  No, NHSN.
    	DR. CARDO.  NHSN is not a web--it is a web-based system--
    	MR. STUPAK.  Okay.
    	DR. CARDO.  --and we do have a website that provides information
    in--
    	MR. STUPAK.  To the general public?
    	DR. CARDO.  --how to prevent infections and everything.
    	MR. STUPAK.  No, as to how my hospital is doing.  If I want to look
    up my hospital, can I go to your website and find out how my hospital is
    doing on infection rates?
    	DR. CARDO.  No, you cannot.
    	MR. STUPAK.  So you collect information for 35 years and the only
    ones who know about it are hospitals, not the public, right?
    	DR. CARDO.  We--
    	MR. STUPAK.  Let me ask you this.  On enforcement, don't you have
    a right to enforce as to hospital's infection rates, which would be
    something that would be serious, underneath Section 1864(c) of the
    Medicare/Medicaid Act, to survey and accredit hospitals participating in
    Medicare, and if there are allegations that suggest the existence of
    significant deficiencies, such as infection, can't you withhold their
    accreditation for Medicare and Medicaid payments?
    	DR. CARDO.  CMS can, and that is the reason we work with CMS.
    	MR. STUPAK.  Well, earlier you said CMS is one of your partners
    here, so wouldn't that be an enforcement mechanism if you really want
    to drive down infection rates?
    	DR. CARDO.  Working with CMS so they can do that, and that is
    what we have been doing.
    	MR. STUPAK.  You have been doing that?
    	DR. CARDO.  That is what I mentioned initially.  The work--
    	MR. STUPAK.  Have you ever--
    	DR. CARDO.  --with CMS--let me rephrase.  We work very closely
    with CMS, so the standards that CMS enforces can be used to better
    prevent infections.
    	MR. STUPAK.  Okay, but has CDC worked with CMS and threatened
    to withhold Medicare and Medicaid payments to a hospital that had high
    infection rates?  Have you ever done that?
    	DR. CARDO.  We are working with CMS in the budget reconciliation
    bill--
    	MR. STUPAK.  Sure, but my question is, have you ever used Sections
    1864(c) to threaten a hospital to clean up its infections rates or you
    would withhold payments under Medicare and Medicaid?
    	DR. CARDO.  Not as CDC.
    	MR. STUPAK.  Okay.  There seems to be some debate whether the
    Pittsburgh Initiative and some of the other groups have put in place very
    specific evidence-based practices that dramatically reduce hospital-
    acquired infections.  We are going to hear from those folks next.  But
    there does not seem to be debate over whether these practices work or do
    not work, in fact, they work quite well.  Why hasn't CDC and then your
    partners there, the Center for Medicaid and Medicare Services, demand
    that these programs be instituted now at every hospital getting Federal
    money?  I mean, you talked about Pittsburgh and we talked about
    Keystone here today, and you said they are good programs, so why
    haven't you required every hospital getting Federal money to institute
    these practices?
    	DR. CARDO.  And that is the reason we are trying more and more to
    improve our relationships with the ones that have such authority, such as
    CMS and Joint Commission, so those things in the future could be done.
    	MR. STUPAK.  So after today, you will start doing that?
    	DR. CARDO.  No, sir, we have been trying.
    	MR. STUPAK.  That is 35 years, though, I mean, when are you going
    to start trying, really start?
    	DR. CARDO.  We are learning from the process and we have
    improved it, and we have been trying even more.  And I think the fact
    that we are here today talking about it shows the knowledge and
    importance for the United States, not just for CDC.  So I hope the fact
    that we are here today can even motivate other groups who have the
    prevention of infections as a priority.
    	MR. STUPAK.  What do we have to do to motivate CDC to do it?  I
    mean, seriously, I am not trying to be flippant here, but hospital stays are
    shorter, infection rates are up.  You testified it is a dramatic thing.  You
    have talked about other initiatives that work.  We've got Mr. Murphy
    over here proposing that we withhold Federal payments to hospitals that
    don't lower their infection rates.  I believe you already have that
    authority under Section 1864(c), so the Murphy legislation may not be
    necessary.  And 35 years that CDC has been looking at it, and I don't see
    any dramatic or I don't see even a recommendation from CDC to tell
    hospitals, clean it up or we will enforce it.  I won't be here 35 years later
    asking you the same questions, but--
    	DR. CARDO.  We have had several recommendations, and we are
    very strong in our recommendations that prevention should be a priority
    and what hospitals should be doing.  I agree that there is a gap between
    what hospitals should be doing and what exactly is happening, and that is
    the reason we are working with partners that have that as a priority, like
    the ones that were mentioned before, to show that if things are done the
    way they should be done, we can prevent infections and save lives.  And
    I think this is the success of the CDC work and with all the partners
    engaged into this effort.
    	CMS is the enforcement authority with regard to hospitals, and I
    would be more than happy to get an answer for you from CMS and
    provide it for the record, because we don't want to talk on their behalf.  I
    can say what we are doing at CDC, but I would be more than happy to
    get--
    	MR. STUPAK.  The last line of your testimony says "CDC is
    strategically positioned to continue to provide leadership in this area."
    We would just like you to start and get these recommendations in and cut
    down on the infection rates.
    	DR. CARDO.  I agree.  Thank you.
    	MR. WHITFIELD.  Dr. Burgess, you are recognized for 10 minutes.
    	MR. BURGESS.  Thank you, Mr. Chairman.  Dr. Cardo, thank you for
    being with our committee today.
    	Now, we keep hearing a figure of 90,000 deaths caused by in-
    hospital infection.  Have we just developed some really strong bugs out
    there, or are there other factors involved here?
    	DR. CARDO.  Ninety-thousand deaths are associated with the
    infections, not all caused by the infections, but you are correct that most
    of the infections we see now are caused by multi-drug resistant
    organisms.  Some of them are very difficult to treat.  In addition to that,
    some of the patients who get infections are sicker, so it sometimes also
    contributes to that.
    	MR. BURGESS.  So not all the patients fit the prototype of the
    otherwise healthy 14-year-old boy who broke his arm on a sled; some are
    going to be patients with co-morbid conditions, some, in fact, receiving
    heroic therapy at the end of life on ventilators for long periods of time
    and that sort of thing?  Is that a correct assumption on my part?
    	DR. CARDO.  It is a correct assumption.
    	MR. BURGESS.  Okay.  What percentage of the hospital-acquired
    infections would you say would be caused from the overuse of
    antibiotics?
    	DR. CARDO.  What we see is the increase, as I said, in resistance and
    not just in the staphylococcus like the MRSA, but also in the gram
    negative bacteria.  And we see infections caused by multi-resistant gram
    negative bacteria, and most of them were related because of the
    transmission of infections from patient to patient, like hand hygiene, but
    also because of the misuse and the overuse of antibiotics.
    	Another problem that we are seeing as a result of the overuse of
    antibiotics is like the emergence of dclostridium difficile infections.
    They are killing more than they used to do before, and they are also
    affecting more people in the hospitals than they did before.
    	MR. BURGESS.  That would be postrating dificilic infections?
    	DR. CARDO.  Yes, so not only the problem in terms of transmitting
    those infections from one person to another, but the overall misuse of
    antibiotics really plays an important role and makes things even worse.
    	MR. BURGESS.  Yeah, I can remember years ago the pediatrician at
    our hospital told us that they were primarily using cantomicin in the
    nursery, and they were saving genomicin because they didn't want to
    overuse it.  The rest of us weren't saving genomicin, we were using it
    hand over fist.  So I don't know what the pediatricians were saving it for,
    and I have always wondered about that.
    	But let me ask you this.  If part of the problem is overuse and over-
    prescription of antibiotics by the physician, by the provider community,
    what do you think would happen to antibiotic use with Mr. Stupak's
    suggestion of withholding Medicare and Medicaid payments to hospitals
    where patients acquire a hospital infection?  Don't you think that is going
    to put people in a position where they will be a little quicker on the
    trigger with starting the antibiotics in the IV?
    	DR. CARDO.  I think if we prevent infections to start with, we don't
    need to treat the infections.  I just wanted to say that because I think it is
    a very important message.  Many times we focus on the management of
    antimicrobial use, and we may go in the wrong direction.  I think if we
    prevent infection, we don't even have the antimicrobial resistance
    problem to deal with.
    	MR. BURGESS.  But let me--for just a second, because if I am a
    surgeon or I am a physician practicing in a hospital and I do an operation
    and I think, oh, golly.  If I get a darn post-op infection, they are going to
    nick me for half of my surgical fee on this, so I am just going to go ahead
    and start triple drug therapy at the time of surgery, rather than let the
    patient run a fever.
    	DR. CARDO.  And that is when it may be a potential problem, but we
    also work with the institutions so they can have systems to monitor
    appropriate use of antibiotics, so you won't have that as an unintended
    consequence of the pay per performance or pay per reporting issue.
    	MR. BURGESS.  Well, really it gets down to collecting the data and
    the proper use and dissemination of that data, and sometimes it does take
    35 years to acquire some of the information that we have to receive.
    	But like most good physicians, one spinal cord synapse will
    generally do, don't generally need a lot of cortical input.  If I don't want
    my patient to get an infection and I don't want to get nicked from a
    Medicare or Medicaid payment, I am going to start the antibiotics.  I
    think that is just normal human behavior, and doctors are not exempt
    from that.
    	Let me just ask you a question, because we are going to run short of
    time.  The collecting of information that can--we don't know if the
    statement you have in your record--and I apologize for being out of the
    room while you gave your testimony, but the statement is "We don't
    know yet if public reporting will reduce the number of infections, but we
    do support the collection of information."  Now, we are going to hear
    from some epidemiologists later on and I will bet they tell us to measure
    is to manage, and I don't know that I will disagree with that statement,
    but since public reporting has been shown to be effective--well, I guess
    to get back to what Mr. Stupak was asking, when you identify a hospital
    with high rates, do you share that with the Joint Commission of
    Accreditation of Hospitals?
    	DR. CARDO.  No, what we do, we call the hospital and we really
    work with the hospital so infections can be prevented.  We cannot share
    that information with other institutions, but--
    	MR. BURGESS.  Why is that?
    	DR. CARDO.  It is because of the CDC authority.  We don't have
    authority to do that, but we work--and I just want to mention that
    monitoring--when we say collect information, it is not just collecting
    rates.  All the information that has been collected in all these years has
    evolved and we have learned more and more, and lots of the
    recommendations that we have now are really based on what we learned
    from information that has been collected.  We are not recommending
    collection of information just for collection of information, and we think
    it is very important, even with this movement for public reporting.  And I
    go back to the comment that was said before, that not only are we
    looking at rates, but we also look at how hospitals are doing in terms of
    adherence to the recommendations that we know can reduce infections.
    	And so again, CDC is a public health agency, and we have limited
    authority, different than other agencies in terms of sharing information or
    sharing the identity of either a specific hospital or a patient.
    	MR. BURGESS.  But if authority to share information with other
    agencies or other organizations, I don't know, perhaps that is something
    we could provide you.  The silo effect there bothers me.  If you have that
    data readily at hand, as a practitioner at a hospital that has such a
    problem, if my administration hasn't made me aware of it, I would very
    much appreciate someone making me aware of it, even if it was the
    CDC.
    	Let me go on, because I am going to run out of time here.  I am a big
    believer in transparency, and I think, as far as our healthcare system, one
    of the real benefits we can give the patients is increased transparency.
    But I also recognize that there is a dark side to transparency.  Opacity has
    value in some venues.  What would be your opinion about the concerns
    you have about public reporting?  Is there a downside to having these
    reports up and available to the public on the Internet?
    	DR. CARDO.  At this point, we believe that public reporting can be a
    tool to really improve prevention, and when we talk about the hospitals
    that report data to our voluntary system, we believe that probably not all
    the hospitals are doing the same thing and following the same standards.
    So it could be a very good motivation for hospitals to really have more
    commitment and more priorities in terms of preventing infections.
    	MR. BURGESS.  So there is no down side to the hospitals--
    	DR. CARDO.  The down side is if we don't do it right, we may
    mislead people, and so I think several things were mentioned here
    before, and they are not just how to provide information, but provide
    information that is meaningful.  And if we want to compare hospitals, we
    need to have some risk adjustment that can really compare hospitals that
    perform different procedures or have different types of patient
    populations.
    	So I think the main thing is we need to make sure that the
    information that is going to be shared is helpful and we are not
    misleading.  It should be information that can be used again for
    prevention.
    	MR. BURGESS.  What is your opinion, not necessarily official CDC
    opinion, but what is your opinion of the top three things that a hospital or
    healthcare provider can do to prevent infections?
    	DR. CARDO.  For hospitals, the first thing that they need to do is to
    have prevention as a priority for them, and to make that as a priority for
    every healthcare provider that works in that institution.  I think that what
    we are seeing with several collaborations is the no tolerance, no excuse
    for not doing what is right, and can you really change--it is a cultural
    change.  I think in the past we said that most of the infections were not
    preventable.  Now, what we need to look at is each infection is
    potentially preventable unless proven otherwise.  And when you change
    that, you really change the motivation that your providers, your
    clinicians, everyone in the institution will have in terms of following all
    the recommendations that we know can prevent infections.  And we have
    seen in collaborations in Pittsburgh, in Michigan, in several groups, that
    when they do that, they see a major improvement in the decrease in
    infections.
    	So I think that is the main strategy.  It is just do the right thing all the
    time, no exceptions.  But leadership is a very important point to get it
    done.
    	MR. BURGESS.  May I just ask one brief follow-up to that?  Are there
    other institutional settings, such as jails, college dormitories, Army
    barracks where multiple antibiotic resistant bacteria are a problem?
    	DR. CARDO.  Yes, probably all the ones that you mentioned.  And we
    see problems in terms, again, inappropriate use of antibiotics and also
    transmission of those infections.
    	MR. BURGESS.  And are you working with those institutions--
    	DR. CARDO.  Yes.
    	MR. BURGESS.  --as hard as you are with your hospitals?  Thank you.
    	MR. WHITFIELD.  Yes, I just have a couple of other questions.
    	We hear a lot about antibiotic resistant bacteria.  You had mentioned
    it, a number of other people had mentioned it, and it is my understanding
    that in Europe, particularly in northern European countries, that they
    have been able to get their MRSA infections down to almost zero by
    doing active surveillance cultures of all high risk patients.  And I was
    wondering, what is your opinion of that?
    	DR. CARDO.  Screening patients when they are hospitalized and then
    isolating patients is an effective way of decreasing infections, but it is not
    the only way.  You do need to have a comprehensive approach.  I think
    the major issue is that you need to have people following
    recommendations, like, washing their hands and following the
    appropriate recommendations to prevent infections all the time.
    	So we have some facilities in the United States that are screening
    patients and being successful, and others are being successful even
    without doing that.  The main issue is to have healthcare providers
    following a recommendation to prevent transmission of infections all the
    time, because MRSA is one problem.  We also see that some of the
    hospitals in Europe, now they are having problems with other bacteria
    with multi-drug resistance.  So I think we need to address the problem in
    a more comprehensive way and really make sure that we are doing our
    best all the time.
    	MR. WHITFIELD.  This is the last question.  The National Quality
    Forum recently announced that it would be endorsing national reporting
    standards for healthcare acquired infections, as well as a standardized
    method for collecting, reporting the data.  Will CDC have any
    involvement in that project?
    	DR. CARDO.  Yes, we do.
    	MR. WHITFIELD.  Okay.
    	DR. CARDO.  We have been involved since the beginning--
    	MR. WHITFIELD.  Okay.
    	DR. CARDO.  --and we have helped them to draft, with other groups,
    what the proposals should be, and we have members of CDC
    participating in all the different committees.  And we are also providing
    all the standards that we have at CDC to see if they should be the
    standards that are going to be considered as national standards.
    MR. WHITFIELD.  Does anyone have any additional questions?
    	MR. STUPAK.  No.
    	MR. WHITFIELD.  Okay.  Well, Dr. Cardo, thank you very much for
    being with us today.  We appreciate your testimony and hope that you
    will continue to maintain focus on this issue, and we look forward to
    working with you as we move forward.
    	DR. CARDO.  Thank you very much for the opportunity for looking at
    this issue.
    	MR. WHITFIELD.  At this time, we will call the third panel forward,
    and I will introduce the third panel at this time.
    	Mr. Marc Volavka, who is Executive Director of the Pennsylvania
    Health Care Cost Containment Council; we have Dr. Richard P.
    Shannon, who is the Chair of the Department of Medicine at the
    Allegheny General Hospital; we have Ms. Chris Goeschel, who is the
    Executive Director of the Keystone Center for Patient Safety and
    Quality; we have Dr. Robert Haley, Southwestern Medical School,
    University of Texas Southwestern Medical Center; we have Dr. Jennifer
    Daley, who is Senior Vice President and Chief Medical Officer of Tenet
    Healthcare; we have Dr. Scott Hammer who is Chief of the Division of
    Infectious Diseases at the New York Presbyterian Hospital/Columbia
    University Medical Center; and we have Dr. Jennifer Hanrahan, who is
    the Chairperson of the Infection Control Committee at the MetroHealth
    Medical Center.
    	Those of you who are members of the third panel, thank you very
    much for being with us today.  We appreciate your patience.  We
    certainly look forward to your testimony, because you have a vast period
    of experience and you are on the front lines of this issue, and we really
    do value your input.
    	As you heard me discuss earlier, any time we do an oversight hearing
    we like to have the witnesses testify under oath.  Do any of you have any
    difficulty testifying under oath today?  And I am assuming you do not
    have an attorney with you today.  So if you would stand--oh, you do have
    a legal attorney, okay.  Is he going to be testifying or--okay.  If you
    would stand and raise your right hands, I will swear you in.
    	[Witnesses sworn.]
    	MR. WHITFIELD.  Thank you very much.
    	Dr. Hammer, it is always good to have your attorney with you, so we
    are glad for that.
    	Okay, at this time we will recognize Ms. Goeschel for your five-
    minute opening statement.

    STATEMENTS OF CHRIS GOESCHEL, RN, MPA, MPS, EXECUTIVE DIRECTOR, MHA
    KEYSTONE CENTER FOR PATIENT SAFETY AND QUALITY; DR. ROBERT WARE HALEY,
    DIVISION OF EPIDEMIOLOGY, SOUTHWESTERN MEDICAL SCHOOL, UNIVERSITY OF
    TEXAS SOUTHWESTERN MEDICAL CENTER; MARC VOLAVKA, EXECUTIVE DIRECTOR,
    PENNSYLVANIA HEALTH CARE COST CONTAINMENT COUNCIL; DR. RICHARD P.
    SHANNON, CHAIR, DEPARTMENT OF MEDICINE, ALLEGHENY GENERAL HOSPITAL; DR.
    SCOTT HAMMER, CHIEF, DIVISION OF INFECTIOUS DISEASES, NEW YORK
    PRESBYTERIAN HOSPITAL/COLUMBIA UNIVERSITY MEDICAL CENTER; DR. JENNIFER
    HANRAHAN, CHAIRPERSON, INFECTION CONTROL COMMITTEE, METROHEALTH MEDICAL
    CENTER; AND DR. JENNIFER DALEY, SENIOR VICE PRESIDENT AND CHIEF MEDICAL
    OFFICER, TENET HEALTHCARE CORP.

    	MS. GOESCHEL.  Thank you, Mr. Chairman and members of the
    committee.  Good afternoon.  My name is Chris Goeschel and I am the
    Executive Director of the MHA Keystone Center for Patient Safety and
    Quality, which is a division of the Michigan Health and Hospital
    Association.
    	In 1999, the landmark Institute report, "To Error is Human"
    suggested that at least 44,000 people die annually in U.S. hospitals from
    preventable medical error.  The report challenged healthcare providers to
    design safer healthcare systems and suggested that most errors do not
    result from individual recklessness, but instead are caused by faulty
    systems, processes, and mistakes.  The MHA concluded that if the
    Institute of Medicine was correct, surely healthcare providers have the
    capacity to fix the system problems and eliminate preventable errors.
    	Early in 2003, the Association established the Keystone Center,
    whose job it is to help all Michigan hospitals translate evidence into
    practice.  Standard strategies for our projects include creating will,
    building relationships, partnering with experts, using our collective
    voice, and being courageous.  The Keystone ICU project, which I am
    going to talk to you about today, has nothing to do with public reporting
    and everything to do with eliminating hospital healthcare-associated
    infections.  The Keystone ICU project is a collaborative project between
    the MHA Keystone Center, 77 hospitals, 127 intensive care units, and the
    quality and safety research group at Johns Hopkins University.
    	In October of 2003, we received critical initial funding from the
    Agency for Healthcare Research and Quality as one of 13 projects
    awarded a patient safety matching grant.  The $1 million that Michigan
    received over two years was matched by over $14 million in cash and in-
    kind contributions by Michigan hospitals that participated in the project.
    Dr. Peter Pronovost from the Johns Hopkins University is the principal
    investigator for the project, and I am the director.
    	Our goals when we began Keystone ICU included to have 80 percent
    of staff in each ICU report positive safety culture, to eliminate catheter-
    related bloodstream infections, and ventilator associated pneumonia, and
    to ensure that evidence-based therapies were provided for patients on
    respirators.  All Michigan hospitals with ICUs were invited to participate
    in the project.  Each team was required to have a senior executive as a
    member of the team, and on a periodic basis, Dr. Pronovost and I sent
    letters to those senior executives encouraging their continued support and
    giving them specific tasks to demonstrate their engagement with this
    project.
    	We could not have accomplished what has happened in Michigan
    without our expert partners.  The Johns Hopkins Quality and Safety
    Research Group developed the interventions that we used in the ICU
    project, they supplied the supporting empiric evidence, they participated
    in the development and evolution of electronic data collection tools, and
    worked with us to analyze the data that we were looking at.  Dr.
    Pronovost and his colleagues on the research team served as faculty at
    biannual workshops, led monthly conference calls with our teams, and to
    this day, we have weekly conference calls with those 127 intensive care
    units.
    	Part of the success of our project, we believe, is bound in the fact
    that we use standardized data collection.  We developed measures based
    on CDC definitions, data collection tools that allowed every hospital
    participating throughout the project to be collecting the same evidence
    the same way, and report it on a regular basis.  We gave them feedback
    on monthly and quarterly bases, we compared their results to aggregate
    State-wide improvements, and every single week we talked with them to
    figure out how the teams that were doing the best were accomplishing
    what they did.
    	What have we accomplished?  Using a predictive model that is based
    on the empiric evidence and actual data collected in our project, during
    the first 15 months of Keystone ICU, we suggest that the ICU teams
    saved over 1,500 lives, 80,000 ICU days, and in excess of $165 million.
    By the end of the 15 months' worth of data collection that was part of the
    AHRQ funded project, those numbers looked at almost 1,578 lives, $175
    million, and 84,000 patients' days.  It is not insignificant to understand
    that Michigan hospitals are now paying for the opportunity to continue
    this important work.
    	Importantly, in the State of Michigan for over a year, the median
    bloodstream infection rate in those 127 ICUs is zero, none, nada.  When
    we started, we were a little over the NNIS mean.  We are now at zero.  A
    bloodstream infection from a central IV catheter in one of our ICUs is a
    rare event and it is treated as such.  It is investigated thoroughly.
    	How did we get there?  We looked at changing the culture.
    Hospitals are complex networks of information, interests, and competing
    priorities, and changing culture is incredibly challenging work.  Our
    explicit goal was to improve the ICU care for patients in every single
    hospital.  We encouraged teams to share what they were learning, and
    they were amazingly candid in doing so.  We discovered early in our
    project that the brightest and most motivated clinicians, even when they
    were presented with the evidence for changing practice, encountered
    obstacles that required new understanding and new skills, and so we
    created a change model that involved engagement, telling the stories, and
    creating the imperative for change.  Education, providing the evidence to
    support the system redesign that we are asking for.  Execution, providing
    the materials and resources that were necessary to collect the data, and
    evaluation, seeing if what we were doing was really making a difference.
    	As we move forward today, there are a couple of key lessons that I
    would like to leave with you that we think have utility for the discussion
    that is happening here today.  We think operational areas for
    improvement must be clearly defined and manageable.  We selected the
    ICU because clearly one-quarter of those healthcare-associated infections
    that have been talked about all day, if you read the literature, those
    infections occur in intensive care units.  If we want to go after infections,
    let us start where we know there are lots of them.
    	Clinical targets have to be equally well defined in significance in
    terms of the opportunity to improve, and supported by clear evidence of
    how to improve.  We have heard today that 35 years worth of CDC data
    on infections hasn't changed.  What we need is help in understanding
    how to go about eliminating the infections that data was suggesting
    absolutely exist.  We believe in voluntary partnering.  Every hospital in
    this State was invited to be part of this, and it was a safe environment in
    which to learn.  We think that freedom from concern about imminent
    public reporting created an environment where clinicians could share
    openly, learn rapidly, and quickly improve care.
    	In Michigan, we have a long and honorable history of voluntarily
    reporting hospital-specific data, but for this project, we really felt it was
    important to get our arms around eliminating the infections.  We believe
    that it is critically important to increase our involvement in health
    services research.  Suggesting as the IOM did that providers could design
    a safer healthcare system as evidence-based assumes that there is clinical
    evidence on what works in the healthcare delivery, and unfortunately, the
    facts don't support that.  As a country, we invest very little in health
    services research.  The NIH budget last year, which is primarily
    dedicated to the development of better treatments for illness, was some
    $29 billion.  The AHRQ budget, dedicated to solving delivery problems,
    was only $320 million.  Put another way, for every dollar that Congress
    allocates to develop breakthrough treatments, it allocates one penny to
    ensure that Americans actually receive those treatments.
    	We believe the MHA Keystone ICU project was a powerful example
    of what Federal pennies can do.  If additional investments were made to
    take what we have learned and support similar expert-led evidence-based
    projects throughout the country, the impact could be profound.  If similar
    pennies were invested in funding health services research to improve
    delivery of surgery care or emergency care or obstetrics care, we would
    likely expedite the pace of measurably improved patient outcomes and
    save money, yet the funding stream to AHRQ remains paltry and current
    AHRQ research priorities are focused primarily on technology, a crucial
    tool for healthcare improvement, but clearly not the only area where
    more research is needed.
    	Finally, we learned that our breathtaking results can serve as
    leverage for additional quality and safety initiatives.  Hospital demand in
    Michigan is high for Keystone projects to address surgical infection
    prevention, and we have a project on the drawing board.  Emergency
    department care and high-risk obstetric care are also priorities.  While
    there are national data collection efforts in all of these areas, there are
    few resources to help us understand how to efficiently improve.
    Evidence is scarce on how we should proceed.
    	In conclusion, as the committee continues its work, we would
    encourage consideration of addressing healthcare-associated infections
    by focusing initially on areas where the evidence is clear and research is
    available on how to implement the needed changes.  We favor voluntary
    initiatives premised on inclusiveness.  We encourage additional funding
    for AHRQ so that research related to designing safer healthcare can be
    expanded.  We encourage the development of funding mechanisms so
    that when initiatives are successful, like Keystone ICU, they can be
    disseminated throughout the country.  We hope there will be additional
    research dollars allocated to support development of needed evidence on
    how to improve care in all high-risk, high-volume clinical settings.
    	Finally, we hope that the decisions regarding public reporting of
    infection data will reflect the complexity of identifying and attributing
    infections.  Changing the impetus from doing good to looking good will
    not serve patients or the industry.  The return on investment for the $1
    million of AHRQ funding is clear.  The Keystone ICU project is an
    example of the genuine improvement that can occur.
    	Thank you, Mr. Chairman.
    	[The prepared statement of Chris Goeschel follows:]

    PREPARED STATEMENT OF CHRIS GOESCHEL, RN, MPA, MPS, EXECUTIVE DIRECTOR,
    MHA KEYSTONE CENTER FOR PATIENT SAFETY AND QUALITY

            Mr. Chairman, members of the Committee and staff - good afternoon.
    My name is Christine Goeschel and I am the Executive Director of the Keystone
    Center for Patient Safety and Quality; a 501( c) ( 3 ) division of the
    Michigan Health and Hospital Association (MHA). The MHA is an association of
    149 not-for-profit acute care hospitals in Michigan. The MHA works to promote
    better health within our communities; improve the quality of patient care;
    and improve coverage for high-quality, affordable health care services for
    all Michigan residents.  The MHA Keystone Center is an essential vehicle for
    achieving the MHA mission, which is to advocate for hospitals and the
    patients they serve.
            In 1999, the landmark Institute of Medicine report To Err is Human
    suggested that at least 44,000 people die annually in hospitals throughout
    the United States as a result of preventable medical errors. The report
    challenged health care providers to design safer delivery systems and
    suggested that most errors do not result from individual recklessness, but
    instead are caused by faulty systems, processes and mistakes.  The
    MHA concluded that if the Institute of Medicine was correct, surely
    healthcare providers have the capacity to fix system problems and eliminate
    preventable errors.
            Michigan hospitals have a long and distinguished record of
    voluntarily working with the MHA and each other to address health care
    issues.  This concern for quality and patient safety was no different.  In
    early 2003 the association established the MHA Keystone Center for Patient
    Safety and Quality, to help all Michigan hospitals "translate evidence into
    practice."   Standard strategies for project development include creating
    will, building relationships, partnering with experts, using our collective
    voice, and being courageous.
            In my comments today I will describe a large and very successful
    voluntary effort that resulted in an unprecedented reduction in IV catheter
    related blood stream infections and ventilator associated pneumonias in
    intensive care units throughout Michigan. Then I will discuss the downstream
    impact of that project and the implications of the effort for health policy
    in Michigan. Finally, I will summarize the key lessons from our experience
    that we believe have broad utility.

    The Michigan Keystone ICU Project
    	The Keystone ICU Project is a collaborative effort between the
    Michigan Health & Hospital Association (MHA)-Keystone Center for Patient
    Safety & Quality, 77 hospitals, and 127 individual intensive care units and
    the Johns Hopkins Quality and Safety Research Group (QSRG). In October 2003
    we received critical initial funding from the U.S. Agency for Healthcare
    Research and Quality (AHRQ) as one of 13 projects awarded a patient safety
    matching grant. The one million dollars of funding we received over two years
    was matched by over  14 million dollars in cash and in-kind contributions
    from the MHA and the hospital participants. Dr. Peter Pronovost from The
    Johns Hopkins University is the principle investigator for the project and
    I am the MHA project director. The ICU improvement project received
    Institutional Review Board approval by the Johns Hopkins University School
    of Medicine.

    Project Goals
            The overall objective of the project is to improve ICU care in
    Michigan.  The specific goals are to have 80% of staff in each ICU report a
    positive safety culture; to eliminate catheter-related blood stream
    infections (CRBSIs) and pneumonia associated with being on a breathing
    machine (ventilator) (VAP); and to ensure that evidence-based
    therapies for patients on ventilators are being used consistently and
    appropriately in each ICU.

    Enlisting Hospital Participation
            All Michigan hospitals with ICUs were invited to participate during
    the grant application process in June, 2003.  Each hospital was required to
    assemble an ICU improvement team, and provide the MHA Keystone Center with a
    list of team members and a written commitment to the project signed by a
    hospital senior executive. At a minimum, the ICU improvement team included a
    senior executive, the ICU director and nurse manager, an ICU physician and
    nurse, and often a department administrator. Hospital senior executives were
    asked to ensure that the ICU physician and nurse would commit 20% of their
    time to the project. In addition, each team committed to implementing the
    specific patient safety interventions, collecting and submitting the
    required data in a timely manner, attending the biannual 1.5 day
    conferences and participating in monthly conference calls.

    Importance of Experts
            The Johns Hopkins Quality and Safety Research Group, as the expert
    partner, developed the interventions used in the ICU project, supplied
    supporting empiric evidence, participated in the development and evolution of
    electronic data collection tools and worked with MHA Keystone Center staff
    to analyze the ICU data. Dr. Peter Pronovost and his research team served as
    faculty at the biannual workshops and led the monthly conference calls.  As
    a means to reinforce senior executive involvement, the principal
    investigator and I periodically sent letters to the CEOs of participating
    hospitals outlining the project's progress and challenging them with tasks
    to demonstrate continued support for their ICU improvement team.  We created
    a manual of operations which included explicit definitions for each process
    and outcome measure. Standardized data collection forms were developed,
    pilot tested, revised and distributed to ICU teams and then converted into
    an electronic format. We provided ICUs with monthly and quarterly
    reports of performance within their ICU and compared their performance to
    aggregate results from the other participating ICUs.

    Resources to achieve the goals
    	 MHA Keystone staff and I interacted with participating hospitals
    via e-mail, phone calls and face to face visits.  In the early months of the
    project it was not unusual to receive over 1500 emails a week. We committed
    to answering e-mails within a business day to keep the hospitals engaged in
    the work of change. I also met regularly with the Johns Hopkins University
    research group. A website (www.mhakeystonecenter.org) was created to provide
    participants access to educational materials, implementation tools, reference
    documents, project data (with encrypted ICU identifiers) and project updates. I provided updates to the MHA Board on a regular basis, and ICU teams were
    asked to provide project reports to their local management teams and senior
    leadership groups.

    Mid-Project Results
    	Using a predictive model based on empiric evidence and actual data
    collected from project participants, the first 15 months of the project
    resulted in savings of 1558 lives, over 80,000 ICU patient days, and in
    excess of $165 million dollars. By the end of the 18 months of data
    collection that were part of the  AHRQ funded project, the predictive model
    suggests that teams saved  1,574 lives, over 84,000 ICU days and over $175
    million dollars. Infections from central IV catheters plummeted. The median
    CR-BSI rate in participating ICU's has now been at zero for almost a year.
    Ventilator associated pneumonia rates in the ICU's have been cut by 40%.
    Forty six ICU's have gone for over six months with no ventilator associated
    pneumonias. Fifty seven ICU's have gone for over six months with no blood
    stream infections from IV catheters .The culture of safety and teamwork as
    measured by the most psychometrically sound instrument  in the field (and
    reflecting the perceptions of nearly 7,000 ICU doctors and nurses) has
    improved by a statistically significant margin, but still has a ways to go.

    Facilitating Culture Change
    	Culture, simply defined is "the way we do things around here."
    Hospitals are complex networks of information, interests and competing
    priorities and changing culture is incredibly challenging work..   Since our
    explicit goal was to improve ICU care for the patients in every participating
    hospital, teams were encouraged to share their experiences and provide social
    support to each other. They were amazingly candid in doing so. We
    discovered early in our MHA Keystone ICU project that the brightest and most
    motivated clinicians, even when presented with evidence for changing
    practice, encountered obstacles that required new understanding and new
    skills.
            We developed a change model designed to help teams navigate the
    system obstacles they encountered.   Our model involves engagement
    (creating the imperative for change), education (providing the evidence
    supporting the system redesign being asked for), execution (providing the
    materials and resources required to redesign work and ensure patients
    receive evidence-based interventions), and evaluation (perform rigorous
    data collection and analysis to determine if patient safety and clinical
    outcomes are improved).

    What We Learned
            There are several important lessons  from this study that we
    believe are important for our interest today in understanding ways to
    eliminate health care associated infections and maximize the usefulness
    of reporting mechanisms.
            1. Operational areas for improvement must be clearly defined and
    manageable. ICU was a target for us because it represents one of the most
    expensive and complex settings in health care, yet typically involves a
    limited set of clinicians with whom to facilitate the work of change. The
    science of safety is new; our interest in making measurable improvements
    demands reasonable steps.
            2. Clinical targets must be equally well defined, significant in
    terms of the opportunity to improve, and supported by clear evidence on how
    to improve.  CDC definitions for catheter related blood stream infection are
    clear and widely accepted. Definitions for ventilator associated pneumonia
    are less clear, but the range is well defined and again, well accepted by
    industry infection control experts. In our case, Dr. Pronovost and his
    research team at Johns Hopkins experts had developed tools to facilitate
    broad and rapid improvement.
            3. Voluntary partnering, with an emphasis on achieving improvement
    in all organizations, facilitated development of a virtual learning
    community. The experts brought rigorous data collection methods and
    measurement, tools to improve care based on the measurement, and empiric
    evidence supporting the changes which would have been inefficient, perhaps
    even impossible to pursue one organization at a time.  The MHA Keystone
    Center was a trusted, local, neutral convener.  This link efficiently and
    effectively allowed unprecedented improvement in record breaking time,
    across a diverse group of ICU's.
            4.  Freedom from concern about imminent public reporting creates an
    environment where clinicians can share openly, learn rapidly and quickly
    improve care. Because the focus of the project was and is to improve care
    for patients, everything else became a secondary issue.  Teams did not
    waste time explaining away less than stellar performance; rather, time was
    spent determining how to improve care by tapping the learning community:
    that is, the 126 other ICU's working on the same initiatives, using the
    same standardized definitions, same data collection methodologies and same
    tools for improvement.  Michigan has a long history of voluntary public
    reporting of hospital specific parameters of care, always structured in a
    way to support consumer use. Yet, the Keystone ICU project leaders agreed
    that public reporting could have changed the focus from "doing good" to
    "looking good". Measuring and improving infection rates is clinically
    complicated.  It would be difficult to present infection information to
    consumers in a way that reflects appropriate consideration in individual
    decision making.   Instead, the focus continues to be to make the best
    evidence based care possible for every individual receiving ICU services in
    a participating hospital.
              5.  Increased investment in health services research is a critical
    component of improving healthcare delivery.  Suggesting that providers can
    design a safer healthcare system that is evidence-based assumes there is
    plentiful evidence on "what works" in health care delivery.  Unfortunately,
    facts don't support that assumption. As a country we invest very little in
    health services research.  The National Institutes of Health (NIH) budget
    last year (primarily dedicated to development of better treatments for
    illness) was some $29 billion dollars.  The AHRQ budget (dedicated to
    solving delivery problems) was only $320 million dollars.  As Dr. Steven H.
    Woolf from the Virginia Commonwealth University stated so poignantly in his
    January 8, 2006 editorial in the Washington Post: "for every dollar congress
    allocates to develop breakthrough treatments, it allocates one penny to
    ensure that Americans actually receive those treatments".     We believe
    MHA Keystone ICU is a powerful example of what federal pennies can do.
    National estimates are that there are nearly 75,000 central line infections
    in ICU's each year, and some 14,000-28,000 deaths.   If additional
    investments were made to take what we have learned and support similar
    expert led, evidence-based projects throughout the country, the impact
    could be profound.  If similar pennies were invested in funding health
    services research to improve delivery of surgery care or emergency department
    care or obstetrics care, we would likely expedite the pace of
    measurably improved patient outcomes and save money.  Yet the funding stream
    to AHRQ remains paltry, and current AHRQ research priorities are focused
    primarily on technology: a crucial tool for healthcare improvement, but
    clearly not the only area where more research is needed.
    	 6.  Payers may support quality and safety improvement efforts that
    are evidence based, involve large cohorts of hospitals and are data driven
    using rigorous methods for data definition and collection.  Blue Cross Blue
    Shield of Michigan (BCBSM), the largest insurer in the state, recognized early
    the importance of the MHA Keystone ICU project.  They had a pre-existing
    quality program in which hospitals could earn an incentive payment for
    achievement of specific quality improvement goals.  MHA Keystone ICU was
    incorporated into this plan for 2004 and 2005.
            Finally, we learned that these breathtaking results can serve as the
    leverage for additional quality and safety initiatives. State-wide
    initiatives are underway to improve stroke care and organ donation rates and
    a Keystone project aimed at eliminating healthcare associated infections is
    in the planning stages.  Health policy committees of the Michigan legislature
    have heard presentations on our work and are enthusiastic about the
    efficiency and effectiveness of our voluntary effort. Hospital demand is
    high for Keystone projects to address surgical infection prevention,
    emergency department care and high-risk obstetric care.  While there are
    national data collection efforts in many of these areas, there are few
    resources to help hospitals efficiently improve. Evidence is scarce
    regarding how to proceed.
            In conclusion, as the committee continues its work, we would
    encourage consideration of addressing healthcare associated infections
    focusing initially on areas where evidence is clear and research is
    available on how to implement needed changes.  We favor voluntary
    initiatives premised on inclusiveness. We encourage additional funding
    for AHRQ, so that research related to designing safer healthcare can be
    expanded. We encourage development of funding mechanisms so that when
    initiatives are successful, they can be disseminated throughout the
    industry.   We hope there will be additional research dollars allocated
    to support development of needed evidence on how to improve care in
    high-risk, high volume clinical settings. Finally we hope that any
    decisions regarding public reporting of infection data will reflect the
    complexity of identifying and attributing infections, and the limited
    evidence on how to prevent them. Changing the impetus from doing good to
    looking good will not serve patients or the industry. The return on
    investment for the $1 million of AHRQ funding is clear. The Keystone ICU
    project is an example of the genuine improvement that can occur when
    hospitals are supported, given expert guidance, firm targets for
    improvement and an opportunity to learn together.      We encourage
    further investments of this type, where the focus can be learning how to
    improve delivery of care and patient outcomes.

    	MR. WHITFIELD.  Thank you.  Dr. Haley, you are recognized for 5
    minutes for your opening statement.
    DR. HALEY.  Thank you, Mr. Chairman.
    	I want to say, I am a convert to public reporting of infection rates.  I
    started my career at the CDC over 30 years ago in the hospital infections
    branch, doing research on this problem.  At that time, it was a problem
    that we knew very little about.  There weren't systematic definitions,
    there was no measurement.  What we found, and I think this is a lesson
    for us in why we are going to do public reporting, we found that when
    we investigated epidemics in hospitals, we would go into a hospital and
    we would immediately meet resistance, particularly if we used the words
    "hospital-acquired" or "healthcare-acquired" and so we made up the
    name nosocomial to reduce the sensitivity of the doctors and the nurses
    and the administrators in the hospital so that they would let us in and let
    us help.  We found that when we measured their infection rates, suddenly
    the resistance melted away.  They saw that their rates were high, higher
    than they thought, and immediately people would ask, as in the Keystone
    project, what can we do now?  But you see, the ingredients in Keystone
    and in all these other individual instances we are going to hear about,
    they are going to talk about how we took these actions and the infection
    rate fell.  Well, how did you know the infection rate fell?  It is because
    you had a measurement first, and the measurement then gets people
    interested that you can get them together and incent them to take these
    actions.  They intervene with things they should have been doing
    anyway, but they didn't because they weren't measuring.  You measure,
    they intervene, the rates go down, and you save lives and we see that
    over and over and over again.
    	We actually did a study back in the '70s and '80s where we took a
    random sample of U.S. hospitals, several hundred hospitals.  We looked
    at 300,000 patients and we looked at hospitals that were doing
    measurement, hospitals that were not doing measurement, hospitals that
    were doing intensive control efforts without measurement or with
    measurement, and then we measured their infection rates over five years
    with an independent system.  We found that in order to reduce the
    infection rates consistently over a number of years, the vital elements
    were you had to have measurement and you had to have control-
    intervention activity.  You had to have both.  If you lacked either one,
    you had no impact.  That is basically still the only major controlled study
    that has looked at the effectiveness of any kind of quality-controlled,
    quality-improved intervention.
    	I was 10 years at CDC.  I then went to Parkland Hospital in Dallas
    about 20 years ago, served on the infection control committee there for
    20 years, and now I am on the Texas Expert Panel for designing our
    statewide reporting system.  So the key thing is, you have got to measure.
    To measure is to control, as we say in infection control.  What gets
    measured gets done.
    	Now, what is also interesting, I just looked on Medline the other day
    before I came.  There are 18,000 scientific papers on the problem of
    hospital-acquired infections published since 1970.  It is a huge amount of
    research.  We know a lot.  We know how to do this.  We don't need more
    research to know what to do.  That doesn't mean we are going to stop
    research, because we can continue to improve, but there is a ton of stuff
    known.  CDC led the way all the way through this thing.  APIC, the
    Association for Professional in Infection Control, and the Society of
    Hospital Epidemiologists helped lead the way.
    	Here is the dilemma.  We know all of this, we have had good
    leadership.  Many of our hospitals are doing just those things that you
    need to do to control the infections.  The problem is a lot more are not
    doing it, have never done it, and are not going to do it until it is
    mandatory.  That is just the way it is.  Up until about a year ago, I would
    have said no, we don't want to make this public because then we will
    alienate the hospitals and they won't participate.  And then Lisa
    McGifford and the Consumers Union came forward and started this
    movement among States and legislatures, and suddenly it occurred to me,
    you know, it has been 30 years, as Representative Stupak said, it has
    been 35 years and we have been waiting for the hospitals to all do it, and
    they didn't do it.  And now the Consumers Union is leading a movement
    to make this public.  It is time.  Then we said it is time, and then we
    found who were our best collaborators, it was the Texas Hospital
    Association.  It was the Hospital Association saying yeah, let us do it.
    Nobody was opposed to it.
    	The real question is how do you do it?  And there is a big argument
    going on now.  It is sort of a clandestine argument.  Is it process
    measures or outcome measures?  There is a big movement, particularly at
    CMS, let us measure process only because it seems easy to measure and
    it seems like, it is really closer to the prevention effort.  I would submit
    to you that it is going to have no impact.  Remember the big study I
    talked about, it is called the Scenic Project.  Unless you have outcome
    measurement and process intervention, if you weigh out both of those, it
    is not going to work.  If all you are going to do is measure process, you
    are going to have process intervention with no outcome measurement, I
    guarantee you there will be no--but that is the way the country is moving.
    I am going to predict that the National Quality Forum, that is what they
    are going to come down heavy on because it is easy to do, seems easy to
    do.  The reason it seems easy to do, we have never done it very much.
    We know all the problems with outcome measurement because we have
    done it a lot.
    	Now, why did I really convert?  Partly it is why I mentioned, but the
    other thing is we have been doing so much measurement in so many
    hospitals for so long, the sensitivity over it is gone.  Hospitals are no
    longer concerned about their infection rates and somebody knowing
    them.  That sensitivity has gone away because we have done it so much,
    and so we are not seeing a push back by the hospitals and the hospital
    organizations.
    	Okay.  Now let me point out, there are three big problems with
    measurement, and the devil is in the details and here they are.
    	For 30 years, we have learned gradually how do you do this, and
    there are some lessons.  First of all, you can't just do something that is
    easy.  You can't just put the numbers of infections up there on a website.
    You know what that is going to do?  It is an easy number and the
    consumers would love it because it is easy to understand, but when you
    just look at the numbers and not the percentage rates, you are going to
    actually steer the patients to the worst hospitals, not to the best ones,
    because--and the same thing with risk adjustment--if you just show the
    hospitals the raw infection rates without risk adjustment, what you are
    going to do is end up sending them to the worst hospitals, not to the best
    hospitals.  And also, just the issue of rates themselves--I am sorry.  The
    completeness of measurements themselves, the hospitals that do the least
    effort, put the least effort into measuring their infections will detect the
    fewest.  Their infection rates will be lowest, they will look the best, and
    then those rates will direct the patients to the worst hospitals, the ones
    that aren't trying.  They are not measuring, and thus not controlling.
    	And so you see, as we designed this we have got to get it right and
    do the things that we worked out in these 18,000 articles over the last 20
    years, and not just take some easy path because it looks easy and looks
    inviting.  We have got to do the research into what really works.
    	Now, let me end up sort of talking about Texas.  Our Texas system--
    	MR. WHITFIELD.  Please summarize.
    	DR. HALEY.  Yeah, that is what I am going to summarize.
    	Basically, in Texas we are going to take the hard road.  We are going
    to measure the hardest things to measure, which is surgical site infection
    rates in a very high percentage rate of our operations, not just in a few
    clean ones, but most of them.  It is going to be a real tough job.  We are
    also going to measure infections in ICUs.  We are going to do rates, we
    are going to do risk adjustment.  And the Texas Department of Health,
    our health department, we are going to collect the data ourselves.  We are
    not going to have our reports go to CDC because if we collect the data
    ourselves, we can do the quality control on it.  We can get patient's
    names because when you have a State law mandating it, you then are free
    from HIPAA and a lot of the legal entanglements.
    	Then what are we going to do when we clean the data and get it all
    ready?  At the end of the year we are going to ship it to CDC for the
    research process so they can aggregate the data.  But we think that is the
    model and where we are going in Texas.  So I think the bottom line is
    measurement is important, just as process activities are important.  You
    have got to have them both.  Most hospitals are not measuring worth a
    darn, and we need mandatory reporting, but at this point, it should be a
    State activity, and as several people have said earlier, we need various
    States to experiment and find out what is the way to do it.  And then, at
    that point, we need a National Quality Forum to do it.  I think it is too
    soon to have a National Quality Forum looking at it.  Certainly, you
    don't want Federal legislation.  We want the States to experiment and
    learn from it.
    	That is my comment.
    	[The prepared statement of Dr. Robert Ware Haley follows:]

    PREPARED STATEMENT OF DR. ROBERT WARE HALEY, MD, DIVISION OF EPIDEMIOLOGY,
    SOUTHWESTERN MEDICAL SCHOOL, UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL
    CENTER

            Good afternoon, members of the Subcommittee on Oversight and
    Investigations.  I thank you for this opportunity to come before you today
    to discuss the critical issue of  public reporting of hospital-acquired
    infections, also referred to as healthcare-associated infections,
    nosocomial infections, or simply hospital infections.
            I should point out that I am a convert.  For 30 years I have
    performed research on this problem and pushed hard for hospitals to measure
    their infection rates and use the information to reduce their infection
    risks of their patients, but not to report them publicly.  But when Lisa
    McGiffert and the Consumer's Union started this national movement for public
    reporting, they created a new perspective that has caused me, like most
    experts in the field, to rethink my position and now to become a strong
    supporter of public reporting.
            In 1973 right out of my medical residency, I joined the U.S. Public
    Health Service as an officer in the Epidemic Intelligence Service at CDC
    and ended up serving there for 10 years.  I worked in the Hospitals
    Infections Branch, a small unit doing the early studies on what then was
    a newly emerging disease problem in hospitals, about which no one knew very
    much.  During my 10 years there, I worked full time in research on the
    problem, developing definitions for the infections, methods of measuring
    them, and ways of using the measurements to reduce the infection risks.
    There I directed a national study called the SENIC Project (Study on the
    Efficacy of Nosocomial Infection Control), in which we studied a
    representative sample of U.S. hospitals to determine what approaches
    actually lead to reductions in hospital infection rates.  In that project,
    we studied over 300,000 patients in several hundred hospitals all over the
    country and found out what works.  This remains the only study ever to test
    whether quality improvement programs are effective.
            We found that measuring the hospital infection rates and then using
    those rates to direct control measures led to large reductions of the
    infection rates over 5 years; whereas, in hospitals that did not measure
    infections rates, the rates either did not change or went up over the 5 year
    period.  In other words, we proved the old saw "what gets measured gets
    done," or as we say about hospital infections, "To measure is to control."
            From this finding and other scientific information, CDC recommended
    that all hospitals voluntarily measure their infection rates to reduce them
    to the irreducible minimum.  Subsequently, CDC and other researchers have
    done extensive research into how to do the measurements so as to get the
    biggest impact in reducing infection risks.  In a computer literature search,
    I found over 18,000 scientific papers on the epidemiology, prevention and
    control of nosocomial infections since 1970. So you can see that there has
    been a tremendous amount of research focused on this problem, and one of the
    main findings is that certain types of measurements of infection rates has a
    powerful impact in reducing infection risks to patients.
            The good news is that, in the past couple of decades, many hospitals
    have adopted these recommendations and have reduced their infection rates
    substantially; the bad news is that another sizeable group of hospitals have
    not adopted this approach.  Years ago hospitals were very defensive about
    infection rates.  We were very concerned that releasing infection rates
    publicly would lead to obstruction of infection rate measurements within the
    hospitals and paradoxically to increasing infection risks for patients.
    But over the years, as measurement became routine-and useful-in many
    hospitals, the defensiveness has declined.  So when Lisa McGiffert and the
    Consumers Union began pushing for public reporting, we encountered little
    objection from hospitals, and instead we saw a way to get all hospitals
    doing the types of measurement they should have been doing all along.
    That's why I became a convert.
            However, there still are some scientific problems with reporting
    hospital infection rates to the public that must be addressed in the state
    reporting systems.  These problems are real.  If not addressed, they could
    cause public reporting to have unintended negative consequences for patients.
    And these problems are what well meaning critics of public
    reporting cite as the basis for their opposition.  Let me trace several of
    them.
            First, there is the problem of accuracy in identifying the
    infections.  These infections are hard to discover.  An expert infection
    control professional must apply standardized definitions.  Many infections
    occur after the patient goes home.  If you just rely on the discharge codes
    assigned by a clerk in the medical records department, you will miss and
    make many errors. Codes depend on what has been documented, but the
    information is written by the physician in a way that considers important
    infection criteria.  The effect is that hospitals that do the best job will
    have higher infection rates than those who give it little effort or who rely
    on clerks not trained in infection control, and so the publicly reported data
    would tend to direct patients to the more careless hospitals rather than to
    the careful ones who are reducing their infection rates.
            Second, many consumers and advocates want very simple numbers of
    infections that they can understand without much thought or study.  Experts
    are rightly concerned about this because simple numbers are misleading.
    Let's take a simple example: suppose one hospital in town has 25 to 30
    surgical infections per month, and the second hospital has twice as many,
    50 to 60 surgical infections per month.  The consumers would understand
    these numbers easily and would decide to go to the first hospital because
    it has fewer surgical infections.  But suppose the first hospital performed
    only one-quarter as many operations as the second.  This would mean that the
    actual risk of infection after surgery would be twice as high in the first
    hospital.  Again, the simple numbers would appear easier to understand but
    would lead the consumers to a much higher risk hospital.  The solution to
    this problem is to report rates of infection-the number of infections divided
    by the number of operations, a percentage-rather than simple numbers of
    infections.  It takes a little thought to understand a percentage instead of
    a number, but it gives the consumer a truer measure of the risk in different
    hospitals.
            Third, a more subtle, but equally serious problem is with differences
    in the intrinsic risk of the patient mix in different hospitals.  Suppose that
    two hospitals perform the same number of operations each month but the first
    hospital does mainly elective hernia operations and coronary bypass operations
    on stable business executives, and the other hospital is a level 3 trauma
    center operating on gunshot wounds to the chest and abdomen and people with
    fresh heart attacks.  The surgical infection rates in the second hospital
    will be several times higher than those in the first hospital, but it is
    likely that the surgeons in the second hospital have better outcomes when you
    compare apples to apples.  Again, consumers seeing simple infection rate
    comparisons might choose the first hospital for their coronary bypass
    operation even though their chance of a complication might be far less in
    the second hospital.  The solution to this problem is to apply what's
    called a multivariate risk index to level the playing field on the
    underlying risk of infection-that is to compare apples to apples.  I
    developed the first index for this purpose, and now a modified version of
    this, called the NNIS (National Nosocomial Infection System) Risk Index, is
    used all over the world.  Again, it takes a little more thought to understand,
    but it gives the consumer a truer measure of the risk in different hospitals.
            From these examples, you can see why well meaning experts would
    oppose public reporting without the qualifiers I've just described.  Today
    that opposition exists because rightly concerned consumer activists want
    simple information on their healthcare facilities.  This information will
    end up misleading those very consumers, directing them to the riskiest
    hospitals rather than to the safest ones, rewarding the hospitals with
    lenient infection control programs and penalizing the most vigorous programs.
            Right now a number of states are developing statewide public
    reporting systems and trying different approaches.  I am a member of the
    expert panel appointed by our Texas state legislature to design our state
    system.  We are putting together a plan that will require all Texas hospitals
    to perform the type of risk-adjusted infection rate measurements that will
    translate into reduced infection risks, and then they will upload their
    datasets to the Texas state health department as a byproduct of doing what
    will control their infection risks.  We are not going to create some
    simplistic administrative activity that takes our infection prevention and
    control professionals away from productive measurement. The data, the state
    of Texas intends on reporting publicly will be the most meaningful
    information for consumers to consider in assessing the safety of different
    hospitals.
            I understand that thirty-four other states have introduced,
    considered or passed bills for public reporting.  Some states are planning
    to have their hospitals' infection prevention and control professionals
    submit their data to the CDC network which may or may not be reported to
    their state and then to the CDC. The National Quality Forum is going to
    develop consensus standards which may not address how data is collected and
    reported.
            In Texas, we are going to handle the whole thing within our state
    and then provide CDC with our collective data for research purposes.
            I personally am not in favor of mandating reporting of infection
    rates on all states until additional research and methods have been tested
    and proven.  I think the various state legislative initiatives will provide
    information on what works best, and then a national consensus may take shape
    naturally.  There is much to learn in this early stage from a diversity of
    state experiments.
            Above all, the scientific evidence is clear.  Measurement of
    infection rates is an essential component of controlling the infection risks
    in a hospital.  What gets measured gets controlled.  Sophisticated
    measurement approaches, including risk adjustment, can make the process
    valid and insightful.  Overly simplistic approaches, while immediately
    attractive, are regressive for controlling infection risks and misleading
    to consumers.  I see both industry leading organizations such as APIC
    (Association for Professionals in Infection Control and Epidemiology), SHEA
    (Society for Healthcare Epidemiology of America) and the Consumers Union
    playing  constructive roles in driving this movement in a productive
    direction at the state level, where it should remain focused for now. I
    expect that the movement will eventually lead to meaningful reduction in
    hospital infection risks as well as to better informed consumers.

    	MR. WHITFIELD.  Thanks, Dr. Haley, and we want all of you to be
    enthusiastic and keep these opening statements within 5 minutes.
    	Mr. Volavka, you are recognized.
    MR. VOLAVKA.  And I could do it real quick by saying I agree with
    him, with one exception, and I think we know where that is going.  I
    think we would have some discussion on risk adjustment.  But I deeply
    appreciate the opportunity to be here, and there is a slide presentation
    that should be up.
    	I am going to start with a riddle.  When is a surgical site infection a
    surgical site infection, and the answer is when the hospital puts them on a
    bill and sends them to the third party payer to pay.
    	Riddle number two:  When is a surgical site infection not a surgical
    site infection?  The answer is when PHC4 is doing a public report.
    	I have already given you my written remarks, but there are six key
    points I would like to make.  The first one that I think is most compelling
    is that hospital-acquired infections are deadly.  This is data based upon
    Pennsylvania's collection.  For every 1,000 patients who get a hospital-
    acquired infection, 130 die.  For every 1,000 patients that do not get a
    hospital-acquired infection, 24 die.  What that means is 104 additional
    deaths for every 1,000 patients.  In other words, if you get an infection in
    the hospital, the odds that you will die during that hospitalization are
    5.41 greater than if you don't.  I don't like those odds.  Nationally, on the
    basis of all underreported data, this translates to 40,000 additional deaths.
    That is approximately 110 people per day.  If 110 people per day were
    dying from the bird flu, I think we would be calling that an epidemic.
    	Second, the cost of hospital-acquired infections is staggering.  The
    statewide average payment, real dollars checks, for a patient hospitalized,
    absent an infection, in Pennsylvania, is $8,000.  The average payment for
    a patient in Pennsylvania hospitalized with an infection is $60,600.  That
    is a $54,000 difference, payment, real check.  And this pie chart will tell
    you in Pennsylvania who is paying most of that bill.  Medicare, 68
    percent of the infections reported in Pennsylvania.  The taxpayers of this
    country are paying this bill, and I humbly suggest that they are paying it
    in 49 other States as well.
    	The cost of hospital-acquired infections continues to place an already
    financially shaky healthcare system at greater jeopardy.  Now, we cannot
    improve what we do not measure.  I absolutely agree with that, and I just
    have to take some issue with the CDC.  This is Representative Stupak's
    point.  This is 20 years of CDC.  Patient days are down, lengths of stays
    are down, surgical things are down.  The incidences of infection is up by
    36 percent.  This is from the New England Journal of Medicine.  Now,
    this same journal at the same time said in its editorial, "If collecting data
    in isolated hospital areas represents best practice, when two million
    Americans develop a hospital-acquired infection resulting in 90,000
    deaths and $5 billion in costs, then best is just not good enough."
    Hospital-acquired infections are preventable.  With patients, payers, and
    providers all losing out, it is hard for me to understand why there is still
    so much debate surrounding this point.  Hospital-acquired infections are
    not inevitable, nor should they be expected.
    	For years, there has been a so-called myth of inevitability, that is, the
    hospital-acquired infections are inevitable byproducts of providing
    hospital-based care.  Too often, blaming inevitability instead of bringing
    some control and standards to current chaos is the norm.  Hospital-
    acquired infections should not be about placing blame or fault.
    However, they also should not be about masking their existence behind
    statistical methodology, like infections per 1,000 line days and language
    like nosocomial that only the experts can understand and explain.  We
    need to get some of the most dedicated people I have ever met, the
    infection control professionals, out of the data collection business and
    onto the floors and into the patient rooms where they can do what they
    are trained to do.  We need to provide them with the resources to support
    them.
    	Don't let the perfect be the enemy of the good.  While I believe, like
    the New England Journal, that the best has been problematic, I do not
    believe that data needs to be perfect, particularly when it comes to data
    collection and public reporting, we don't need pine needle detail, data
    perfection, or epidemiological purity to shine light on a problem.  Those
    who argue about needing perfection before we publicly report miss both
    the light and the point.  Sometimes sunshine is the best disinfectant.
    	Public reporting works.  Public reporting is the first step and not the
    only step in measuring the extent of the problem and the effectiveness of
    solutions implemented.  Public reporting does change behavior.
    	With that said, my final message today is that the States have
    historically been and continue to be the incubators for innovations and
    solutions, and as such, their role in transforming the Nation's healthcare
    system needs to be engaged and enlarged.  In testifying before the U.S.
    Senate two weeks ago, Paul O'Neill said, "Unfortunately, the Federal
    government rarely sets performance targets at all, let alone setting them
    at the theoretical limit of human attainment.  The result of not insisting
    on the elimination of fundamental problems with the performance of the
    healthcare system is more of the same or worse."  I believe Mr. O'Neill
    was right.  States need the flexibility and the Nation benefits when States
    are encouraged to experiment with solutions that may work toward the
    common goal, while recognizing the unique socioeconomic and political
    environments that vary dramatically among the 50 States.
    	Rather than setting a single standard on the whats and hows of data
    collection, what Congress can do best is establish performance targets
    and goals and then provide incentives the States can use.  If Congress
    said simply and clearly in 5 years, the goal of our healthcare delivery
    system should be to eliminate all hospital-acquired infections, and in 5
    years, Medicare will no longer pay for any hospitalization in which a
    hospital-acquired infection occurs, I humbly suggest the goal of patient
    safety that we all share would be transformed into action virtually
    overnight by a hospital and physician community.  There could be no
    more noble or compelling issue for Congress or the Nation to tackle.
    	Mr. Chairman, with all due credit to a former Member of this august
    chamber, I would like to close with the following observation.  I think
    we all agree that this is an elephant, and I think we all agree that this is a
    mouse.  And since Pennsylvania began its path of recording, I have been
    accused more than once of seeing pink elephants where none exist.  But
    to me, this is a pink elephant, and yet those who argue for scientific
    purity and epidemiological perfection might challenge me and say no,
    that is an inference, not a fact.  That could just as easily be that mouse
    you just showed with a glandular condition because of the metal he was
    eating.  Well, when it comes to hospital-acquired infections, Mr.
    Chairman, to me, and I think to virtually every citizen of this country, it
    really doesn't matter if you call it a pink elephant or a mouse with a
    glandular condition, because on this one, the public gets it.  They know
    hospital-acquired infections are bad.  They know they don't want one.
    They know they don't want their family or their friends to get one, and
    they know that if they must be hospitalized, they would like to have
    information about the facilities in their area that have the lowest possible
    number.
    	They get it, Mr. Chairman, and on this issue, what they actually get
    is they don't want to get it.  I think it is time to stop, to roll up our
    sleeves, stop wringing our collective hands, and start washing them.
    	Mr. Chairman, on behalf of the Governor and the General Assembly
    of Pennsylvania, my council members who set our policy in direction,
    and the incredibly dedicated staff of my tiny little obscure State agency, I
    humbly thank you for the privilege and the honor of testifying here
    today.
    	[The prepared statement of Marc Volavka follows:]

    PREPARED STATEMENT OF MARC VOLAVKA, EXECUTIVE DIRECTOR, PENNSYLVANIA
    HEALTH CARE COST CONTAINMENT COUNCIL

    ?	Pennsylvania began collecting data on hospital-acquired infections
    in January 2004.  Almost every state has the capability to establish a
    reporting system based on Pennsylvania's model.
    ?	The Pennsylvania Health Care Cost Containment Council (PHC4) has
    found that the patient safety and financial impact of hospital-acquired
    infections is larger than originally reported.  During the first nine months
    of 2005, Pennsylvania hospitals confirmed more hospital-acquired infections
    than for all 12 months of 2004.
    ?	Hospital-acquired infections are deadly.  You are over five times
    more likely to die during a hospital admission in which you acquire an
    infection than if you don't.
    ?	The costs of hospital-acquired infections are staggering.  Payment
    data suggests that, on average for commercially-insured patients, there was
    a $52,600 difference between hospital admissions in which the patient
    acquired a hospital-acquired infection and one in which the patient did not.
    ?	Hospital-acquired infections are not inevitable, nor should they be
    expected.  Simple and effective methods, such as hand washing, using gloves,
    and properly sterilizing equipment, can dramatically reduce and/or eliminate
    hospital-acquired infections.
    ?	We cannot improve what we do not measure.  Requiring the collection
    and publicly reporting of data are two steps in measuring the extent of the
    problem and identifying solutions.
    ?	Don't let the perfect be the enemy of the good.  When it comes to data
    collection and reporting on hospital-acquired infections, the data need not be
    perfect.  In fact, we ultimately need to find ways to get infection control
    professionals out of the data collection business and into the business of
    finding and preventing hospital-acquired infections.

            Mr. Chairman and Members of the Committee:
            Good afternoon, my name is Marc P. Volavka, and I am the Executive
    Director of the Pennsylvania Health Care Cost Containment Council.  I am
    honored to have the opportunity to address this Committee today and to talk
    about the importance of publicly reporting hospital-acquired infections.
            Last summer, the Pennsylvania Health Care Cost Containment Council -
    often referred to by its acronym, PHC4 - issued a landmark report on
    hospital-acquired infections.  Thus, Pennsylvania became the first state
    in the nation to put some hard figures around the incredible burden of
    these infections.
            While we expected to receive some attention, we were, quite frankly,
    astounded by the firestorm of debate that tiny, four-page report caused.
    Since our first report, PHC4 has issued two additional briefs on
    hospital-acquired infections, one of which has just been released today.

    Data Collection and Reporting in Pennsylvania
            I thought I should begin by giving some background on Pennsylvania's
    data collection process.  I also think it is important to set the record
    straight about what PHC4 did and did not report in our groundbreaking
    Research Brief.  First and foremost, despite what some have said, we did
    not use "billing data" to identify hospital-acquired infections.  The
    infections listed in our reports were identified, submitted and confirmed
    by Pennsylvania hospitals.
            To define hospital-acquired infection, PHC4 adopted, with minor
    clarifications, the Centers for Disease Control and Prevention (CDC)
    definition:  an infection is a localized or systemic condition that 1)
    results from adverse reaction to the presence of an infectious agent(s) or
    its toxin(s) and 2) was not present or incubating at the time of admission
    to the hospital.  Essentially, what this means is: you didn't come in with
    it, and you got it in the hospital.  Frankly, this is not a difficult
    concept to grasp.
            PHC4 also adopted the CDC's 13 major site categories that define
    the hospital-acquired infection location, and expanded the list of 13 to
    include a category for multiple infections and to differentiate device
    related and non-device related infections.  We then redefined a
    two-character data field (Field 21d) on the Pennsylvania Uniform Claims and
    Billing Form, which is submitted along with administrative and billing data
    for each inpatient hospital admission.  Hospital personnel enter one of a
    defined set of codes into this field when the relevant hospital-acquired
    infection is present.  Almost every state in the nation is already
    positioned to use the uniform billing form in a similar manner.
            In Pennsylvania, data collection began in January 2004, and
    hospitals were required to submit data to PHC4 on four types of
    hospital-acquired infections: surgical site, urinary tract, pneumonia,
    and bloodstream infections.  The data collection requirements were
    gradually expanded over a period of several quarters, and as of January 2006,
    Pennsylvania hospitals are now required to submit data on all
    hospital-acquired infections.
            So what did PHC4's first report on hospital-acquired infections
    reveal?  In 2004, Pennsylvania hospitals confirmed 11,668 hospital-acquired
    infections.  The hospital admissions in which these infections occurred were
    associated with an additional 1,510 deaths, 205,000 extra days of
    hospitalization and $2 billion in additional hospital charges.  While these
    numbers are certainly shocking, what is chilling is that the figures
    were underreported - just the tip of the iceberg.  PHC4's most recent report
    released today, which looks at only the first three quarters of 2005,
    underscores that the problem of hospital-acquired infections is larger and
    more costly than originally estimated.  It also highlights the difficulty in
    getting a standard, consistent and understandable form and format to identify
    and collect this information.
            During the first nine months of 2005, Pennsylvania hospitals
    confirmed and reported 14,526 hospital-acquired infections. If the reporting
    trend continues for fourth quarter, we will approach 20,000 identified HAI's
    for all of 2005.
            13,711 of the 14,526 are identical to the 4 categories that were
    confirmed and reported in 2004 -- the 11,668 figure.  The hospital admissions
    in which these 13,711 infections occurred were associated with an additional
    1,456 deaths, 227,000 extra hospital days and $2.3 billion in additional
    hospital charges.

    Hospital-acquired Infections Are Deadly
            While I think all of this background is important, there are really
    six key points I would like to make today based on Pennsylvania's public
    reporting experience.  The first, and perhaps most compelling, is that
    hospital-acquired infections are deadly.
            As I previously mentioned, based on only nine months of 2005 data
    from Pennsylvania hospitals, the hospitalizations with hospital-acquired
    infections were associated with 1,456 additional deaths.  Extrapolated
    nationally, this translates to almost 40,000 additional deaths annually.
    That's approximately 110 people per day dying nationally.  If 110 people
    were dying daily from the Bird Flu, I think we'd be calling that an
    epidemic.
            While I hate to throw out too many numbers because real people and
    real lives are at the heart of this issue, a comparison of the mortality
    rates of patients with and without hospital-acquired infections is also
    eye-opening.  Of the 13,711 Pennsylvania patients with a hospital-acquired
    infection in first nine months of 2005, 13 percent died, compared
    to 2.4 percent of patients who did not contract such an infection.  What
    that means is, you are over five times MORE likely to die during a
    hospitalization if you get an infection, than if you don't.  Those aren't
    good odds.

    The Costs of Hospital-acquired Infections Are Staggering
            Just as hospital-acquired infections are a major patient safety
    issue, their financial implications are staggering, which brings me to my
    second point.  The cost of hospital-acquired infections continues to place
    an already financially shaky health care system at greater jeopardy.
    Through insurance premiums and tax dollars, Americans are spending
    exorbitant amounts of money on these infections, which are, in almost all
    instances, preventable.
            Again, based on only nine months of 2005 data, the hospital
    admissions in which these infections occurred were associated with $2.3
    billion in additional hospital charges, just in Pennsylvania.  Extrapolated
    nationally, the total would reach $46 billion.
            As our research brief issued today identifies, Pennsylvania has also
    become the first state in the nation to put hard numbers around actual
    payments.  Pennsylvania received actual payment data from third-party
    commercial insurers and matched it to the hospitalizations for 2004 in which
    the reported hospital-acquired infections occurred.  In 2004, the average
    payment - that is the actual payment, not charge - for a hospitalization
    with a hospital-acquired infection was $60,678.  The average payment for a
    hospitalization without a hospital-acquired infection was $8,078.
            This data shows that, on average, there was a $52,600 payment
    difference between hospital admissions with and without a hospital-acquired
    infection.  As a result, we estimate additional insurance payments to
    Pennsylvania hospitals from the private sector, Medicare and Medicaid at
    $613.7 million for the 11,668 hospital-acquired infection cases in 2004.  To
    extrapolate for all of 2005, with the assumption that payments did not
    change at all (not a solid assumption) we estimate that payments made to
    hospitals for patients who get a hospital-acquired infection will be over
    $1.2 billion in Pennsylvania alone.  That would be $24 billion in payments
    nationally.  And, this is only the hospital portion of the payment.  It does
    not include the additional physician payments, or the ongoing care many of
    those patients need, if they are the lucky ones who survive the infection.
            This is a major concern to Pennsylvania businesses and labor unions
    that pay insurance premiums through the commercial market and to public sector
    programs.  It also contradicts those who say there is no low-hanging fruit in
    health-care cost savings left to find.
            Now, as compelling as these numbers are for the health care
    purchasers paying the tab, there is an equally compelling business case for
    hospitals to prevent hospital-acquired infections.  While hospitals get paid,
    on average, seven times more for a patient that acquires an infection, work
    done by Dr. Richard Shannon, under the auspices of the Pittsburgh Regional
    Healthcare Initiative, and continued by others, indicates that the cost of
    treating these infections far exceeds the extra payment received.  I believe
    Dr. Shannon will testify more on this point, so I will leave that to him.

    Hospital-acquired Infections Are Not Inevitable
     	With patients, payers and providers all losing out, it is hard to
    understand why there is still so much debate surrounding my third point.
    Hospital-acquired infections are not inevitable, nor should they be expected.
    These infections can be prevented.  For years, there has been this so-called
    myth of inevitability - that is, hospital-acquired infections are the
    inevitable byproducts of providing hospital-based care.  This myth has
    persisted despite the fact that simple and effective methods, such as hand
    washing, using gloves and properly sterilizing equipment, can dramatically
    reduce the incidence of hospital-acquired infections.
            Too often, blaming "inevitability", instead of identifying and
    correcting poor processes of care, is the norm.  Hospital-acquired infections
    should not be about placing blame or fault, with either patients or providers.
    However, they also should not be about masking their existence behind
    statistical methodologies like "infections/1000 line days" and language like
    "nosocomial" that only the "experts" could understand or explain.  When
    talking about hospitals, if you didn't come in with it, and you got it in
    the hospital, to me, that's a hospital-acquired infection.
     	The new moniker; "healthcare-associated infections", concerns me,
    because it has the potential to blur and soften the implications of, and the
    solutions for, infections acquired while hospitalized.

    We Cannot Improve What We Do Not Measure
            Of course, finding solutions is ultimately what we should be about.
    That is why PHC4 has a history of public reporting.  We cannot bring
    attention to problems that see no light.  We cannot improve what we do not
    measure.
            Obviously, not all of the feedback PHC4 has received with respect
    to its publicly reporting hospital-acquired infections has been positive.
    One of the criticisms we have received is that our public reporting about
    this deadly issue does not help to improve care.  In fact, we have heard
    over and over again from industry officials that reporting infection rates
    is not the same as reducing infections.  Well, on that point, I agree.  But,
    if you don't collect data, you can't identify the problem; and if there is
    no public accountability, where is the incentive to provide solutions?
            After PHC4's first report was issued, one of our critics said,
    "There is no evidence to support the public disclosure as a means to reduce
    the incidence of these infections."  My response to was that he was only
    half right.
            There is no evidence to support public disclosure because public
    disclosure of hospital-acquired infections has never been done - until now.
            We have also been cautioned about the potential consequences of
    mandatory reporting for hospital-acquired infections.  It has been argued
    that such mandatory reporting may deflect resources from patient care and
    prevention, mislead stakeholders if inaccurate data is published, and cause
    some physicians to avoid treating sicker patients.  This theme - "the
    unintended consequences of public reporting" - has been repeated in
    the recent literature on public reporting.
            Let me address this issue head on.
            First, while there may not be any evidence yet that public reporting
    DOES help reduce the incidence of hospital-acquired infections, I would
    humbly suggest there is ample evidence that the way we have been doing
    business over the past 30 plus years, which has relied heavily on private,
    voluntary, non-public collection and analysis of data by the CDC is NOT
    working.
            In an article published in the New England Journal of Medicine in
    2003 they reported that nationally between 1975 and 1995:

    ?	The number of patient days decreased by 36.5%
    ?	Lengths of stay decreased by 32.9%
    ?	The number of inpatient surgical procedures decreased by 27.3%
    ?	The number of infections decreased by 9.5%

            However:

    ?	The incidence of nosocomial infections per 1,000 bed days increased
    by 36.1% (New England Journal of Medicine, 348:7, 2003)

    	It was these statistics that caused the Journal to publish the
    following remarks in its editorial:

            "If collecting data in isolated hospital areas represents "best
    practice" when 2 million Americans develop a hospital-acquired infection,
    resulting in 90,000 deaths, and $5 billion in cost, then best is just not
    good enough." (New England Journal of Medicine, 348:7, 2003).

            To echo the title of today's hearing, PHC4 believes that public
    reporting IS about saving lives and money by empowering consumers and
    purchasers of health care benefits.  Public reporting is the first step in
    measuring the extent of the problem and the effectiveness of solutions
    implemented.  Public reporting changes behavior.  The best scientific
    evidence of this is the most recent study done by Dr. Judith Hibbard, and
    published in the July/August 2005 issue of Health Affairs, indicating that
    hospitals that were publicly reported on in Wisconsin had significant
    quality improvement the following year - while those that were NOT publicly
    reported on, and that had only private feedback, or no feedback at all,
    showed little, if any, improvement.
            And with respect to hospital-acquired infections, PHC4 believes
    that by providing objective, comparative data to the public, both patients
    and third-party payors can make more informed decisions about choosing a
    hospital and our hospitals themselves, with heightened awareness of the
    seriousness of this issue, and with the potential for public accountability,
    will more rapidly implement better and more contemporary infection control
    practices.
            PHC4 works under the philosophy that the public reporting of health
    care data is the policy approach that saves the most lives and best
    stimulates quality improvement.  This philosophy is, in fact, consistent
    with the Administration's current goal of increased health care price and
    quality transparency.  And the case for public reporting can be made
    by several PHC4 achievements.  For example, since PHC4 began publicly
    reporting patient mortality rates for Pennsylvania hospitals, these rates
    have dropped from significantly above the national average in 1993 to
    significantly below the national average in 2003.  Similarly, mortality
    rates for coronary artery bypass graft surgery in Pennsylvania have dropped
    48% in the past ten years, mirroring the years of public reporting by PHC4.
    And, Hannan, Chasen et al, demonstrated that in the case of the two
    states that had been publicly reporting on CABG mortality the longest, New
    York and Pennsylvania, the decrease in CABG mortality was significantly
    greater that that experienced across the nation at large. (Medical Care,
    2003).
            One of the other criticisms I would like to address is the rhetoric
    of the "meaninglessness" of our data, perhaps best articulated in an August
    2005 Governing magazine article:

            "Put out these gross statistics and people get all alarmed, but
    what are they going to do with this data? If you think hospitals are going
    to scramble and fix it, then maybe, but I don't think that's what will happen.
    I think they will look at the data and call it what it is - meaningless."

            Meaningless? To whom?
            The following letter to the editor appeared in the July 29, 2005
    issue of the Pittsburgh Post Gazette:

            I was interested in reading about hospitals and infections ("Alarms
    Raised on Hospital Infections," July 12). My husband went into one of the
    large hospitals in the Pittsburgh area for a heart catheterization and was
    told he needed open-heart surgery. I spoke with the surgeon after the
    operation and was told that the operation was a success. After about four
    days of intensive care, I saw a new bag hanging beside the bed and asked
    why and what for. I was told he had an infection and needed an antibiotic.
    I asked how did he get an infection. The reply was "Everyone thinks that
    hospitals are the cleanest places in the world, but they are not." My
    husband died on the 12th day in the intensive care unit. Remember the old
    saying, "The operation was a success, but the patient died"? How true."

            ELINOR ROGERS McGINN
            Churchill

            And, on July 18, 2005, Frederick K. Miller said:

            "I am glad to see a state agency doing its job!  My wife had three
    operations.  The Dr. did not address her infection for a year after surgery.
    She got the infection at a local hospital.  There is a low staff of nurses.
    I had several relatives get an infection at the same hospital.  One of them
    died."

            While I take issue with the notion that our data is meaningless, I
    am cognizant of the fact that the data on hospital-acquired infections needs
    to be improved, and made both meaningful and actionable.
            And, with all due respect and deference to the CDC, what is currently
    viewed as the national standard for gathering information on hospital-acquired
    infections - the National Nosocomial Infections Surveillance System (NNIS)
    and the definitions and guidelines that it uses - does not meet the mark.
    This voluntary system has operated for over 30 years, involves data
    collection which is not comprehensive, consistent or comparative and, for
    the most part, is not publicly available.
            In a study of the NNIS data collection/reporting, conducted by the
    Centers for Disease Control and Prevention itself, and subsequently reported
    in a 1998 issue of Infection Control and Epidemiology, three separate groups
    of infection control experts reviewed 1136 patient charts in order to
    determine the consistency, objectivity and credibility in using such a
    surveillance system for identifying hospital-acquired infections.  After a
    review of the charts, results from abstracters at nine NNIS participating
    hospitals indicated 611 infections were present.  A second group of trained
    reviewers evaluating those same patient charts found 474 out of those 611
    infections reported were in fact, hospital-acquired infections, but also
    found 790 additional infections not reported by the hospital, for a total of
    1264.  Finally, in a review of the charts by CDC personnel themselves, 525
    out of the 611 were identified as hospital-acquired infections with an
    additional 340 infections not reported for a total of 865 total infections.
            The study, in my eyes, demonstrates that, a voluntary, hospital-based
    reporting system used to monitor hospital-acquired infections and guide the
    prevention efforts of infection control practitioners, is neither objective,
    nor consistent; and brings all the biases that human judgment and diffuse
    guidelines produce.  In today's age of technology and the ability to
    electronically download lab, pharmacy, and other vital clinical data,
    private companies like MedMined, Theradoc, Cereplex, and others have already
    developed software tools that in a far more automated way, detect and
    identify hospital-acquired infections.  Just as it is with a patient's
    medical record and history, it's time to let the paper and pen go.

    Don't Let the Perfect Be the Enemy of the Good
            I believe, to its credit, that the CDC will acknowledge some of the
    shortcomings of the manner in which the NNIS database was collected, and the
    problems with very complicated and often misinterpreted definitions.  While
    I believe it has been problematic, I do not believe that the data needs to
    be perfect.  That is why my fifth message is that we cannot let the perfect
    be the enemy of the good.  When it comes to data collection and public
    reporting, we do not need pine needle detail, data perfection or
    epidemiological purity to shine light on a problem.  Those who argue about
    needing perfection before we publicly report, miss both the light, and the
    point.  Sometimes, sunshine is the best disinfectant!
            In fact, we need to find ways to get some of the most dedicated
    people I've met - the physicians in infectious disease and our infection
    control professionals - out of the pine needles of manual data collection,
    and onto the floors and into the rooms of hospitals, so they can do the job
    they were trained for - finding and preventing the causes of the
    hospital-acquired infections.
            I also think I can safely say that the pattern in Pennsylvania, as
    well as in other states that embrace public reporting, is that once health
    care data gets reported, the data gets better and so do the improvement
    efforts.

    States are the Incubators of Health Care System Innovation
            With that said, my final message today is that states have
    historically been, and continue to be, the incubators for innovation and
    solutions, and, as such, their role in transforming the nation's health care
    system needs to be engaged, and enlarged.  In addition to shedding light on
    the problem of hospital-acquired infections, Pennsylvania, and others, have
    led the way in other efforts to promote greater transparency in health care
    through collecting and reporting health care data.   Florida, Maine, New York,
    Maryland, New Jersey, and Virginia are also laboratories of transparency,
    using different outcome measures and different data collection methods, but
    all aimed at the same goal:  greater public transparency on both quality and
    cost.
    	In testifying before a U.S. Senate Committee two weeks ago, Paul H. O'Neill said:

    	"Unfortunately, the federal government rarely sets performance
    targets at all, let alone setting them at the theoretical limit of human
    attainment. The result of not insisting on the elimination of fundamental
    problems with the performance of the healthcare system is more of the same,
    or worse. For example, there are clear reasons that the appalling
    healthcare-acquired infection rate - affecting approximately 1 in 12 people
    admitted to the hospital -- has been steady or increasing for decades."

            I believe Mr. O'Neill was right.  It's time to stop wringing our
    collective hands, and start washing them!
    	States need the flexibility, and the Nation benefits, when states
    are encouraged to experiment with solutions that may work toward a common
    goal, while recognizing the unique socio-economic and political environment
    that varies dramatically amount the 50 states.
    	Rather than setting a single standard on the "what's and "how's" of
    data collection, what Congress can best do is establish performance targets
    and goals, and then provide incentives that states can use, with flexibility,
    and, given their own limited resources, begin to act on reducing and
    eliminating hospital-acquired infections.
    	If Congress said simply and clearly:  In five years, the goal of our
    health care delivery system should be to eliminate all hospital-acquired
    infections, and, in five years, Medicare will no longer pay for any
    hospitalization in which a hospital acquired infection occurs; I humbly
    suggest the goal of patient safety that we all share would be transformed
    into action virtually overnight by our hospital and physician community.
    	There could be no more noble or compelling issue for Congress, and
    our nation, to tackle.
    	While the public may not fully grasp the nuances of a risk adjusted
    mortality rate, or how to decipher HEDIS measures on appropriateness of
    preventive care outcomes, when it comes to hospital-acquired infections, the
    public "gets it"!  Hospital-acquired infections are bad.  They don't want one;
    they don't want their family or friends to get one; and they want to know,
    should they have to be hospitalized, which hospitals in their area are doing
    the best to prevent them.
    	In fact, what the public fully "gets" is, they DON'T want to "get it".
    	In Pennsylvania, we're doing our best to provide usable, actionable
    information to see that this goal is achieved.
    	Mr. Chairman, on behalf of the Council members that set our
    priorities and agenda, and with pride in the dedicated and talented staff of
    PHC4, I thank you for the honor and the privilege of testifying here today.

    	MR. WHITFIELD.  Well, thank you, Mr. Volavka.
    	At this time, I recognize Dr. Shannon for his 5 minutes.
    DR. SHANNON.  Thank you, Mr. Chairman.  I will ask my colleague,
    Mr. Volavka, to help tee up a couple of slides I would like to share by
    way of illustration.
    	It is my goal today to convince you that hospital-acquired infections
    are not inevitable, but products of unreliable processes and mal-aligned
    incentives that reward activity, not clinical outcomes.
    	A major challenge to the concept of public reporting has been the
    theory of inevitability, the notion that a hospital-acquired infection is an
    inevitable consequence of complex care, and therefore an acceptable
    form of collateral damage in our daily battle against disease.  An
    additional barrier, however, is the fact that we shroud this problem in
    epidemiologic metrics that are obscure and tend to hide the human face,
    thereby mitigating the harm.
    	As an example, we were reporting for years an average infection rate
    of 5.1 infections per 1,000 line days.  One day, I said how many human
    beings is that?  Five, 10, 50?  There was simply no way to know.  When
    data is presented in obscure fashions, it may be understandable to an
    epidemiologist, but I submit that we, and I venture to say most healthcare
    professionals, were totally unaware of the tragic human consequences or
    of our primary involvement in them.  As a result, it becomes easy as a
    healthcare professional to dismiss such a common occurrence as
    unavoidable or inevitable.
    	We now know at Allegheny General Hospital that with respect to
    hospital-acquired infections, there is only one acceptable benchmark:
    zero.  The unambiguous goal of zero that no one should contract an
    infection in a hospital that did not arrive with it obviates the need for a
    complex metric.
    	Now, the argument that the data needs to be normalized in order to
    compare hospitals of different sizes and types, simply to my mind
    focuses the attention on the wrong set of comparisons.  Rather, I would
    submit the correct approach is for each hospital to benchmark against
    itself in its current condition and to demonstrate rapid and consistent
    progress toward the theoretical limit.  If the public were to know that we
    were all getting better, it would be greatly reassured.
    	And to those that argue that their patients are sicker, I say please
    hurry, because that is all the more reason to perfect your processes, as I
    know of no critically ill patient that gets better when a superimposed
    hospital-acquired infection occurs.
    	But the best way for me to challenge the myth of inevitability is to
    illustrate how close you can come to the theoretical limit.  Over the last
    32 months, we have dedicated ourselves to the proposition of eliminating
    hospital-acquired infections using work redesign borrowed from
    industries such as Toyota and ALCOA, which are leaders in producing
    reliable products.  I won't belabor the data on this first slide.  It is
    included in the testimony and you have heard today through the
    Washington Post that we have been successful in reducing our line
    infections from 49 to 3 and our deaths from 19 to 1.  What I want to tell
    you about these results is they have occurred at the same time that we
    have seen a doubling of the use of central catheters and we have seen a
    steady increase in the acuity of illness in our patients as measures by the
    Atlas severity grade.  Said differently, using more catheters and caring
    for sicker patients are not justifications for higher numbers of infections.
    In our ICUs, we decided to replace the flawed theory of inevitability with
    the proven principles of reliability in practice.
    	Now, needless to say, when you define a hospital-acquired infection
    as inevitable, you also create the rationale for paying for it, but little is
    known as to whether the hospitals actually make or lose money on these
    cases.
    	[Slide.]
    	To explore this, we have looked at 54 central line infections from our
    institution, and I want to just share a few factors from them.  We believe
    that an economic analysis must begin with an understanding of exactly
    how the harm occurred and specifically how it affected the patient.  So I
    share with you the case of a 39-year-old man who came to our hospital,
    not with a critical illness, but with pancreatitis, an inflammation of his
    pancreas due to high plasma triglycerides.  On the sixth hospital day, this
    man developed a central line-associated bloodstream infection with
    methacillin resistant staphylococcus aureus due to a femoral line that had
    been in place for four days.  As a result of that bacterium, he developed
    multiple surgical complications requiring repeat laparoscopies to drain
    abscesses, he developed renal failure requiring dialysis, he needed to
    undergo a tracheotomy to maintain his ventilation, and 86 days after this
    man came to our hospital, he was discharged to a long-term care facility.
    	Now, I don't share this with you because I am proud of it; I share it
    with you because unless you understand the human consequences, there
    is no motive to change.  Healthcare workers are not motivated by line
    infections per 1,000 line days, but they renounce a current condition
    when they understand the magnitude of the human harm expressed in
    such human terms, and they begin to believe they can do something
    about it.  Next slide.
    	[Slide.]
    	Now, at Allegheny General Hospital, we have had a chance to look
    at the economics of such cases.  In the right-hand panel, you see that we
    got paid $200,000 for this care, yet it cost us $241,000 to provide it,
    meaning we lost from operations a full $41,000 on this case alone.
    Notably, the care provided as a result of the complication cost $170,000,
    or nearly 71 percent of the entire cost of care.  In addition, I have shared
    for you in this slide risk adjustments that you constantly hear about.
    These are three different sets of patients, all age-matched, matched by
    their Atlas severity grade at the time of admission, and matched for their
    admitting diagnosis.  In the left-hand panel, you can see that when we
    actually do it right in the pancreatitis, the payment is much less, $5,900,
    but so too is the cost.  Yet as a hospital, we make a cool $119 on average.
    	Arguably, this patient was sicker, due to the initial presentation with
    hypertension and partial pancreatic obstruction, but in the second
    illustration I provide you with the common finding that our hospital is
    paid very well when it provides an advanced level of care, the kind of
    care we are expected to provide, particularly when it is surgical care.
    And in such complex cases, we have a very nice operating margin of
    $40,000.
    	By the third comparison, though, I show you two other patients who
    developed severe pancreatitis and needed to be intubated for long periods
    of time and required a tracheotomy.  Again, our hospital is well paid,
    $125,000 for such complex care, even though the result is less than
    optimal.  And the margin, $27,000 remains quite healthy.  Yet in the case
    of my 37-year-old patient, when complex care is further complicated by
    a central line infection, the economic turns sharply negative with an
    operating margin of -$41,000.  These costs do not include payments to
    physicians, they do not include the cost of long-term care, his ongoing
    dialysis, or the loss of a productive worker.  Next slide.
    	[Slide.]
    	This is the average data for 54 infections.  $64,000 is the payment,
    $91,000 is the cost.  We lose $26,000 on average for every infection.
    $1.4 million is the operating loss per year.  Only three people went home.
    Next slide.
    	[Slide.]
    	I am going to click through to the bottom in the interest of the
    Chairman's time.
    	We have reduced both ventilator-associated pneumonia and central
    line infections in our organization.  This has resulted in savings that
    approach $2.2 million over two years.  We received a $2.1 million
    incentive payment for the good work.  That means this work alone in two
    ICUs netted for the hospital a new operating margin of $4.3 million.  In
    the course, we spent $34,000 in investment, not one penny of Federal
    money, and we admitted 126 additional patients to our unit, and we
    saved 47 lives.
    	Mr. Chairman and members of the committee, it is quite obvious
    what we need to do.  We do need to measure, but more importantly, we
    need to act.  This is a win-win.  It is a win for patients, it is a win for
    providers, it is a win for payers, and it is a win for purchasers.  We need
    to be about it, and we need to be about it now.
    	Thank you.
    	[The prepared statement of Dr. Richard P. Shannon follows:]

    PREPARED STATEMENT OF DR. RICHARD P. SHANNON, MD, CHAIR, DEPARTMENT OF
    MEDICINE, ALLEGHENY GENERAL HOSPITAL

                                       Summary
    Hospital Acquired Infections: The Conspiracy of Error and Waste in Healthcare

    1.	Hospital acquired infections in general and central line infections
    (CLABs) and ventilator-associated pneumonias (VAP) in particular are not
    inevitable consequences of complex healthcare but are indicative of unreliable
    processes and perverse economic incentives.

    2.	These infections and their consequences can be reduced through work
    standardization and commitment to safety as a precondition of caring for
    patients.

    3.	The costs of these preventable infections in both human and economic
    terms are staggering and largely unappreciated by both payers and hospitals.

    4.	Preventing these infections could free up limited resources now wasted
    in their care.

            Mr. Chairman and Members of the Committee:
            It is an honor to be asked to testify before this distinguished body
    on a matter of vital national interest. You are undoubtedly aware of the
    litany of statistics from the Institute of Medicine and Centers for Disease
    Control defining the national epidemic of hospital acquired infections and
    you  have heard specifically about the magnitude of the problem in the
    Commonwealth of Pennsylvania. I will not reiterate these findings. The
    fact remains that these numbers are so staggering as to be almost
    imponderable, suggesting that the problem is complex and insolvable.
            Rather, it is my goal today to convince you that error and harm in
    healthcare is not inevitable, but a product of unreliable processes and
    misaligned incentives that reward activity not outcome. I will demonstrate
    using our own work that public reporting is not only accurate and informative,
    but establishes the basis for action. I will then show you that at an
    individual hospital level, hospital acquired infections in general and
    central line infections and ventilator associated pneumonias in particular
    cost our hospital and others like it millions of dollars and hundreds of
    human lives, illustrating the conspiracy of error and waste prevalent in
    healthcare.
            The work that I will present was performed at Allegheny General
    Hospital, a large academic medical center located in Pittsburgh's inner city.
    We are a major teaching affiliate of the Drexel University College of
    Medicine, a mentor hospital of the Institute for Healthcare Improvement and
    a founding member of the Pittsburgh Regional Healthcare Initiative, a
    regional collaborative established by former Treasury Secretary Paul O'Neill
    and Karen Feinstein PhD.

    The Theory of Inevitability
            A major challenge to the integrity of public reporting is the notion
    that hospital-acquired infections are an inevitable consequence of complex
    care and therefore an acceptable form of collateral damage in a daily battle
    against human disease.  The notion of inevitability has its genesis in the
    fact that when infections occur, the root cause is not determined immediately.
    Three or more months after the fact when the infection is finally reported,
    the cause of the infection is not apparent, leading to the conclusion that it
    must be inevitable. Yet, there is no biological basis or genetic mutation
    that predisposes to hospital-acquired infections, although there are
    recognized conditions that pose a greater risk.
            A major barrier in addressing the issue of hospital-acquired
    infections is the fact that we shroud the problem in epidemiological metrics
    that obscure the human face, thereby mitigating the harm. As an example, in
    work from our Medical Intensive Care Unit and Coronary Care Unit, we were
    reporting average infections rates of 5.1 infections per 1,000 line-days. But
    how many human beings did that represent? Five? Ten? Fifty?  When the data were presented in such an obscure fashion, we, and I venture to say most
    healthcare professionals, were unaware of the tragic human consequences or
    our own involvement in the events. As a result, it is then easy to dismiss
    these common occurrences as "unavoidable or inevitable". Until recently, the
    best we could do was benchmark against available "norms" such as the National
    Nosocomial Infection Surveillance data, generating a list of what has become
    known in safety circles as "the cream of the crap". We now believe that with
    respect to harmful conditions in healthcare, the only acceptable benchmark is
    the pursuit of the theoretical limit. Simply stated: zero infections. The
    unambiguous goal of zero.that no one should contract an infection in the
    hospital that they did not have when they arrived .obviates the need for any
    complex metrics. The Pennsylvania Healthcare Cost Containment Council should
    be commended for reporting the actual number of infections in just such an
    unambiguous fashion.
            The argument that normalization of data is necessary to compare
    hospitals of different size and types simply focuses attention on the wrong
    set of comparisons. The correct approach is for each hospital to demonstrate
    consistent progress toward the theoretical limit. To those that argue that
    their patients are sicker, I say then all the more reason to perfect your
    processes as no critically ill patient gets better with a superimposed
    hospital acquired infection.
            I would like to challenge the notion that hospital-acquired
    infections are inevitable by demonstrating that it does not have to be this
    way. Over the course of the last 32 months, we have dedicated ourselves to
    the proposition that we can eliminate hospital acquired infections through
    work redesign borrowing from the lessons of Toyota and Alcoa, industry
    leaders in producing reliable products. The principals of Perfecting
    Patient Care? are an adaptation of the industrial methods employed by the
    Toyota Production System and the Alcoa Business System, but designed for
    healthcare and taught in a 5-day course developed and sponsored by Pittsburgh
    Regional Healthcare Initiative.  I will not focus on those processes here to
    but rather refer you to the PRHI website (www.prhi.org) where the process is
    outlined in greater detail.
            Figure 1 illustrates the progress toward the eradication of central
    line infections. We have reduced the number of central line infections
    progressively from 49 to 3, deaths associated with these infections from 19
    to  1 and improved the safety and reliability of the process from 1 infection
    in every 23 lines placed to 1 in every 535 lines placed as of the end of
    February, 2006. We have not had a central line infection in these two critical
    care areas since August 14,2005. The progress to zero has occurred despite a
    near doubling in the use of catheters and a steady increase in the severity
    of illness of patients in our ICUs. Stated differently, using more catheters
    and caring for sicker patients are not justifications for higher numbers of
    infections.

    Do Hospitals Make Money on Central Line Infections?
            Needless to say, when you define hospital-acquired infections as
    inevitable, you also create the rationale for paying for them. But little is
    known as to whether hospitals make or lose money when care is complicated by
    hospital-acquired infections. Therefore, understanding the economy of
    hospital-acquired infections is essential to changing the culture.
            To explore this issue we examined the payments and expenses
    associated with 54 central line infections in our two ICUs over three years.
    In our work, each economic analysis begins with an understanding of exactly
    how the error occurred and specifically how it affected the patient (Figure
    2).
            A thirty-nine year old video programmer, father of four was
    admitted with acute inflammation of the pancreas due to elevated plasma
    triglycerides. On the third hospital day, he developed hypotension and
    metabolic acidosis related to pancreatic inflammation and required pressor
    support and mechanical ventilation. On day 6, he developed fever
    and recurrent hypotension. Blood cultures were positive for methacillin
    resistant staphylococcus aureus and the same organism grew from his femoral
    venous catheter that was placed four days previously. He developed multiple
    complications from the catheter related bacterial sepsis including
    intra-abdominal abscesses requiring multiple laproscopic drainage
    procedures and renal failure requiring dialysis. The prolonged course
    required that he undergo tracheotomy to facilitate ongoing requirements for
    mechanical ventilation. Finally, after 86 days in the hospital, he was
    transferred to an acute long-term care facility for further rehabilitation.
            Now, I do not share this with you because I am proud of it, but
    rather, to illustrate the human face and the actual harm that can accompany
    these infections. Health care workers are not motivated by epidemiological
    metrics such 5 infections /1000 day days, but they renounce the current
    condition when the magnitude of the error is expressed in its human
    dimensions and when they come to believe that there is something that they
    can do about it. The consequences to the patient are considerable and a
    sufficient cause for action, but what are the economic implications?
            In Figure 3, we see that Allegheny General Hospital received
    $200,765 in payments for the care rendered; yet the hospital costs were
    $241,844, such that the loss from operations was -$41, 813 on this single
    case. Notably, the additional care provided as a result of the preventable
    central line infection and its associated complications amounted to
    $170,565 or nearly 71% of the total cost of care with an 86-day
    hospitalization. Now, I want to emphasize that these are actual hospital
    costs, not charges that were actually billed as $828,847!
            In addition, I want to share three comparisons with our case as
    illustrated in Figure 3. In the first example, you see the economics from
    the hospital's perspective for providing good basic care to three other
    patients that presented with the same diagnosis. When we do it right, the
    payment is much less ($5,907), the costs are much less, but so too is the
    hospital margin (+ $119).
            Arguably, our patient had a more severe case of pancreatitis due
    to the initial hypotension and presence of partial pancreatic obstruction.
    In the second illustration, you see the common finding that our hospital is
    well paid ($99,214) for providing an advanced level of care, particularly
    surgical care, in such a complex case, with an operating margin of
    + $40,309.
            A third comparison is made with two other patients who developed
    severe pancreatitis, required prolonged mechanical ventilation, and
    eventually underwent tracheotomy, similar to our patient. Again, our
    hospital was well paid ($125,576) when complex care results in a less
    than optimal outcome, although the margin is less (+$27,482) than that
    seen with complex surgical care alone.
    	Yet, in the case of our 39 year-old patient, when complex care is
    further complicated by a central line infection, the economics turn sharply
    negative for our hospital with an operating margin of -$41,813.
            Now this is all from the hospital's perspective. These costs do not
    include payments to physicians and for long term care or for the patient's
    need for ongoing dialysis or the loss of a productive laborer in the
    workforce. But, let me highlight for you what society pays for these various
    levels of care. The payment increases progressively as care becomes both
    complex and complicated from $5,907 to $200,031, yet the patient's outcome
    is inversely proportional to the payment.
            In summary, I have illustrated in Figure 4 the economic impact on
    hospital operating margins of 54 central lines infections that we examined
    from our two ICU's. The average payments was $64,894, yet the average costs
    were $91,733 such that the hospital had a negative gross margin of $26,839
    per infection and a total negative gross margin of $1,449,306. The average
    payment for a central line infection in my two ICUs is a number that is
    remarkably close to what has been reported by PHC4 in the Commonwealth of
    Pennsylvania.
            In Figure 5, I provide a similar summary of the economic and
    clinical impact of 99 ventilator associated pneumonia (VAP) cases in the
    same two ICUs over 3 years. The average payment was $62,883, but the costs
    were $87,318, such that the average loss from operations was -$24,435 per
    case, totally a three-year loss of $2,419,065. The payments in cases of
    ventilator-associated pneumonias were twice those in comparable cases
    ($33,569) uncomplicated by this preventable hospital acquired infection.
    With a similar approach using the principals of Perfecting Patient Care?,
    we reduced the number of ventilator-associated pneumonias from 45 to 8.
            Finally, I would like to highlight the economic benefits to our
    hospital as a result of nearly eliminating two classes of HAI over the
    last two years, illustrated in Figure 6. The work has resulted in
    operational improvements of  +$2,238,927 and an additional $2,100,000 in
    incentive payments totaling $4,338,927 in improvements. We invested a
    total of $34,927 over two years to achieve the result. In the process, we
    have increased the number of admissions to the ICUs by 126 and saved 47
    lives. Thus, our hospital has incurred substantial losses when care was
    complicated by a hospital-acquired infection. On the other hand, both our
    patients and we have benefited by efforts to eradicate these insidious
    infections.
    	Mr. Chairman and distinguished Members of the Committee,
    The greatest and certainly most expensive healthcare system in the world is
    teetering on the brink of a financial crisis and is an unbearable drag on
    the nation's economy. The unreliable systems of care delivery and the unsafe
    conditions that are created as a result undermine the promise of new
    technology and threaten our ability to afford it. The value added from the
    elimination of hospital-acquired infections is more than sufficient to
    provide insurance for the growing number of uninsured and working Americans
    as well as to give us a down payment on the promising new technologies that
    offer real hope for eradicating disease. Before us lies the first and most
    important challenge to realize these goals. Are we as informed citizens and
    as an honorable profession willing to commit together to eliminate the harm
    and the waste associated with preventable hospital acquired infections?
            Thank you

            MR. WHITFIELD.  Thank you, Dr. Shannon.
    	Dr. Hammer, you are recognized for five minutes.
    DR. HAMMER.  Thank you.  Mr. Chairman and distinguished
    members of the committee, good afternoon.  Thank you for convening
    this hearing on policy issues surrounding the benefits of reporting
    healthcare associated or hospital-acquired infections.  My name is Dr.
    Scott Hammer and I am the Chief of the Adult Division of Infectious
    Diseases and a Professor of Medicine and Epidemiology at the New
    York Presbyterian Hospital/Columbia University Medical Center, the
    largest single hospital in epidemic medical center in the New York
    metropolitan area.  On behalf of the NYPH, I appreciate the opportunity
    to testify this afternoon and share my insights on the benefits and
    challenges presented by measures requiring hospitals to collect, monitor,
    and report HAI data.
    	At the outset, I would like to acknowledge the importance of the
    committee's inquiries into HAIs, an issue that poses significant
    challenges to the public health system in the United States.  In a February
    2005 report, HICPAC estimated that each year, HAIs account for two
    million infections and $4.5 billion in excess healthcare costs.  As
    significant as these statistics may seem, they do not adequately convey
    the impact that HAIs can have on the lives of patients and their families.
    Accordingly, NYPH supports efforts to require the public reporting of
    HAI data, provided that it is collected and calculated properly and
    conveyed to the public in a responsible, comprehensive, and meaningful
    manner.  Thus, any approach mandating the disclosure of HAI rates
    should address two fundamental issues.
    	First, any effort should establish national standards regarding
    methodologies for the collection of HAI data, the collection of HAI rates,
    and the presentation of HAI rates.
    	Second, the reporting framework should establish an effective risk
    adjustment procedure to direct for variances amongst patient populations
    with respect to underlying risk factors for infection.  Currently, multiple
    Federal and State regulatory frameworks provide guidance for the
    collection and dissemination of HAI data.  These approaches differ in
    certain respects, however, often directing facilities in different States to
    adopt varying definitions and methodologies.
    	This present lack of methodological consensus means that hospitals
    adopting different approaches will not be subject to valid comparisons,
    which is one of the primary goals of public reporting.  Thus, in order to
    be of value to the healthcare community and the public, any public
    reporting system should establish uniform methodologies for collecting
    data and calculating rates.  It is important to assure that hospitals be
    required to provide data in a consistent manner.
    	Even when opting to gather similar types of data, hospitals can
    choose to monitor different processes and outcomes.  Each of these
    approaches may be equally valid, yet quite distinct.  As a result,
    comparisons among hospitals using disparate measures would be
    uninformative.  Attempts to produce a comparison among these statistics
    could prove misleading and potentially harmful to our Nation's
    healthcare consumers.
    	Another concern inherent to HAI reporting is that healthcare
    facilities treat an array of patient populations reflecting various levels of
    acuity.  For instance, as an academic medical facility, NYPH often
    performs very specialized and high-risk procedures.  NYPH also serves
    as the burn center for the New York City Fire Department and cares for
    numerous patients who have received an organ transplant.  Due to the
    use of immunosuppressant medications, each of these patient groups
    inherently is vulnerable to the threat of elevated HAI rates, which would
    require risk adjustment prior to being reported so as to allow meaningful
    comparison to other patient groups and facilities.
    	Furthermore, without effective risk adjustment to correct for these
    disparate patient populations and acuity levels, it could be quite
    challenging to generate a meaningful comparison between HAI rates at
    academic medical centers and other tertiary hospitals with the rates
    observed at a typical community hospital.  Moreover, it has become
    increasingly difficult to identify whether some infections were acquired
    while at the hospital or within the community.  Risk adjustment,
    therefore, is critical because it enforces the validity of inter-hospital
    comparisons and addresses whether an infection likely was acquired
    during or prior to a patient's hospital stay.
    	Unfortunately, the risk adjustment methods currently available are
    limited in their ability to account for these differences.  The result may
    be that unadjusted or poorly adjusted HAI rates may lead to unintended
    and undesirable public health consequences.  For example, a patient
    misinterpreting HAI data may avoid seeking treatment at a particular
    facility, despite its being more experienced and better equipped to treat
    the patient's condition.  In order for the public reporting of HAI rates to
    achieve the committee's objectives, to improve hospital performance and
    to provide patients and their families with educated decision-making
    tools, such rates should be reviewed and adjusted for among other
    considerations, acuity level, and patient mix.
    	In addition, Federal and State reporting agencies should remind
    consumers that HAI rates are not to be viewed in isolation.  Consumer
    interest groups and professional associations also should play a role in
    this process to educate patients and their families about the benefits and
    limitations of HAI data.  In the end, the public should understand that
    HAI rates represent only one of a myriad of factors to be used in
    deciding where to receive quality healthcare.
    	Thank you, Mr. Chairman, and I would be pleased to answer any of
    your questions after the opening statements.
    	[The prepared statement of Dr. Scott M. Hammer follows:]

    PREPARED STATEMENT OF DR. SCOTT M. HAMMER, MD, CHIEF, DIVISION OF INFECTIOUS
    DISEASES, NEW YORK PRESBYTERIAN HOSPITAL/COLUMBIA UNIVERSITY MEDICAL CENTER

            Mr. Chairman, distinguished members of the Committee and staff -
    good afternoon.  Thank you for convening this hearing on policy issues
    surrounding the data collection and reporting of hospital-acquired
    infections ("HAIs"). My name is Dr. Scott Hammer, and I am the Chief of the
    Adult Division of Infectious Diseases and a Professor of Medicine and
    Epidemiology at the NewYork-Presbyterian Hospital/Columbia University
    Medical Center ("NYPH").  NYPH is the largest single hospital and academic
    medical center in the New York metropolitan area, and is affiliated with two
    medical schools:  the Columbia University College of Physicians & Surgeons;
    and Cornell University's Weill Medical College.  Collectively, our five
    separate campuses serve a vast geographic region and a diversity of
    communities.  On behalf of NYPH, I appreciate the opportunity to testify
    this afternoon and share my insights on the benefits and challenges
    presented by legislative measures requiring hospitals to collect, monitor
    and report HAI data.

    I.  Overview
            At the outset, I would like to acknowledge the importance of the
    Committee's inquiry into HAIs - an issue that poses significant challenges
    to the public health system in the United States.  In a February 2005 report,
    the Healthcare Infection Control Practices Advisory Committee ("HICPAC")
    estimated that each year, HAIs account for two million infections, and $4.5
    billion in excess healthcare costs.  As significant as these statistics may
    seem, they do not adequately convey the impact that HAIs can have on the
    lives of patients and their families.
            Accordingly, NYP supports efforts to require the public reporting
    of HAI data, provided that it is collected and calculated properly, and
    conveyed to the public in a responsible, comprehensive, and meaningful
    manner.  Thus, any approach mandating the disclosure of HAI rates should
    address two fundamental issues.  First, any effort should establish national
    standards regarding methodologies for:  (i) the collection of HAI data;
    (ii) the calculation of HAI rates; and (iii) the presentation of HAI rates.
    Second, the reporting framework should establish an effective risk-adjustment
    procedure to correct for variances among patient populations with respect to
    underlying risk factors for infection.
            In order to formulate an effective national reporting system, this
    process will require consultation among the various public and private
    stakeholders, including:  (i) the Centers for Disease Control and Prevention
    ("CDC"); (ii) state health departments; (iii) hospitals and other health care
    facilities, including academic medical centers; (iv) national associations
    representing infection control practitioners, such as the Association for
    Professionals in Infection Control and Epidemiology ("APIC"), and the
    Society for Healthcare Epidemiology of America ("SHEA"); and (v) non-profit
    patient advocacy groups.

    II.  Lack of Consensus Among Federal and State regulatory frameworks on
            Methodologies for Collecting and Calculating HAI Data
            Currently, multiple federal and state regulatory frameworks provide
    guidance for the collection and dissemination of HAI data.  These approaches
    differ in certain respects, however, often directing facilities in different
    states to adopt varying definitions and methodologies.  This present lack of
    methodological consensus means that hospitals adopting different approaches
    will not be subject to valid comparisons, which is one of the primary goals
    of public reporting.  Given the technology, effort and expense required
    to gather accurate HAI data, it is important to insure that hospitals be
    required to work within a single regulatory regime with respect to HAI
    reporting.
            On the federal level, no law currently in effect requires public
    reporting of HAI data.  On a voluntary basis, however, some hospitals
    presently report HAI data to the National Nosocomial Infections Surveillance
    Network ("NNIS"), sponsored by the CDC.  NNIS requires participating
    hospitals to collect HAI data using standardized protocols called
    "surveillance components," which target the adult and pediatric intensive
    care, high-risk nursery, and surgical patient units.  For a minimum period
    of one month, participating hospitals must track all incidences of HAIs
    within the surveillance components.  They then categorize incidences of
    HAIs into major and specific infection sites, using definitions developed
    by the CDC.
            The CDC/NNIS methodologies for collecting HAI data and calculating
    HAI rates have been influential and form the closest existing approximation
    to a national standard.  But the CDC/NNIS standard has not achieved universal
    acceptance.  Notably, the only federal legislation that would require
    hospitals to report HAI data appears in a provision of the Deficit Reduction
    Act ("DRA").  Enacted on February 8, 2006, but not yet in effect, the DRA
    adopts neither the CDC definitions for HAIs, nor the CDC/NNIS
    rate-calculation methodologies.  Rather, the DRA directs the Secretary of
    Health and Human Services (the "Secretary") to develop the agency's own
    definitions and methodologies for collecting HAI data and calculating HAI
    rates, in consultation with the CDC and other appropriate national consensus
    building entities.  The Secretary also must select two HAIs for acute care
    hospitals to track through admission and discharge codes, and include
    pneumonia and surgical site infection data in its group of quality indicators.
    The DRA expands the number of quality indicators that acute care hospitals
    must monitor and report in exchange for receiving the maximum price inflation
    adjustment under the Medicare program.  And, under the DRA, by October 1,
    2008, Medicare would not provide a facility with full reimbursement of
    treatment expenses if patients develop either of these two selected HAIs.
            On the state level, six legislatures have enacted laws mandating
    public reporting of HAIs.   Many of these have yet to become effective, with
    others merely in the early stages of implementation.  Like the DRA, however,
    a number of these states have opted to direct the development of their own
    methodologies on collection of HAI data and calculation of HAI rates, rather
    than adopt the CDC or NNIS models.  New York, for example, requires its
    Department of Health to create methodologies for infection identification,
    coding, tracking and reporting.  The Pennsylvania law establishes similar
    requirements.  On the other hand, Florida requires its hospitals to collect
    HAI data using the distinct methodologies developed by the Centers for
    Medicare and Medicaid Services ("CMS").
            Given that federal and state regulatory frameworks employ disparate
    methodologies for collection of HAI data and for calculation of HAI rates,
    attempted comparisons among hospitals falling within different regulatory
    frameworks may yield results that are suspect and difficult to interpret.
    Thus, in order to be of value to the healthcare community and the public,
    any HAI reporting system should establish uniform methodologies for
    collecting data and calculating rates
            One proposed approach towards achieving this uniformity would be
    to require hospital participation in NNIS.  NNIS then could make its HAI
    database available to state agencies, which could use the data to compare
    hospitals and identify potentially problematic trends.  Where appropriate,
    such state agencies could take further action against specified hospitals.
            Such mandatory hospital participation in NNIS would pose challenges
    for two reasons.  First, the CDC is in the process of redesigning the NNIS
    system into a user-friendly web-based resource, called the National
    Healthcare Safety Network ("NHSN").  Although there has been no formal
    announcement of a precise launch date, the CDC projects that the NHSN will
    be operational at some point in 2006.  Until that occurs, and understandably
    for some period of time afterwards, the system may undergo additional
    changes toward becoming an effective resource for the health care community.
            Second, the NNIS (as well as the successor NHSN), is designed to
    report only outcome measures, which establish the rate of infection for
    certain diseases within targeted patient populations (e.g., the number of
    patients who contract pneumonia from ventilators).  Moreover, the NHSN
    changes the current list of NNIS outcome measure requirements by collecting
    data for a narrower range of HAIs - namely, central-line associated
    bloodstream infections, ventilator associated pneumonia, catheter-associated
    urinary tract infections, and surgical site infections.
            Highlighting the lack of consensus with respect to HAI reporting,
    the NNIS approach does not provide for the collection or distribution of
    information regarding adherence to process measures, which determine the
    hospital staff's adherence to procedures believed to reduce the spread of
    HAIs (e.g., the number of influenza vaccinations administered to staff).
    Notably, the HICPAC report concluded that outcome measures, like the ones
    required by NHSN and NNIS, often are more difficult to observe accurately
    than process measures.  In its view, process measures should form the core of
    a mandatory reporting system because:  (i) they are easy to observe; (ii)
    hospitals should unambiguously aim for 100% adherence to measured processes;
    and (iii) they do not have to be adjusted for a patient's underlying risk of
    infection.  Consequently, HICPAC believes that outcome measures are more
    costly to implement, but ultimately produce a less reliable indication for
    the performance of HAI control programs.

    III.  Lack of COnsensus Among Hospitals on Methodologies for COllecting and
    Calculating HAI Data
            Hospitals have long employed differing methodologies for collecting
    HAI data and calculating HAI rates.  For instance, a given facility may track
    process measures, outcome measures, or a combination of both as indices of
    their own internal HAI-related performance. Accordingly, it would not be
    meaningful to attempt a comparison between the HAI rates of a hospital using
    primarily process measures with one primarily observing outcome measures.
            Even when opting to gather similar types of data (i.e., process
    measures vs. outcome measures), hospitals can monitor different processes
    and outcomes.  For example, NYPH calculates HAI rates through outcome
    measures by conducting targeted surveillance of specific types of infections,
    including:  (1) central venous catheter bloodstream infections in the
    Intensive Care Unit ("ICU"); (2) surgical site infections in select patient
    populations; (3) epidemiologically-significant resistant organisms, such as
    Methicillin-resistant Staphylococcus Aureus ("MRSA") and Vancomycin-resistant
    Enterococcus ("VRE"); (4) Rotavirus infections; and (5) Respiratory Syncytial
    Virus ("RSV") infections.  NYPH also monitors certain process measures
    associated with HAIs, such as hand hygiene (through a direct observation
    program), and influenza vaccination rates (based on the number of staff
    members who receive an immunization).
            On the other hand, our peer hospitals that also monitor process
    measures may reasonably have selected alternative procedures to target.
    Similarly, when tracking outcome measures, other facilities may collect data
    on different infectious agents.  Each of these approaches may be equally
    valid, yet entirely distinct.  As a result, comparisons among hospitals using
    disparate measures would be uninformative.  Attempts to produce a comparison
    among these statistics could prove misleading and potentially harmful to
    our nation's healthcare consumers.

    IV.  The Importance of Standardizing Risk-Adjustment Procedures
            From one facility to the next, healthcare facilities treat an array
    of patient populations, reflecting various levels of acuity.  By virtue of
    our geographical location and affiliation with Columbia University Medical
    Center and Weill Cornell Medical Center, NYPH serves a wide range of
    communities, including some of the nation's most vulnerable, living within
    economically-disadvantaged neighborhoods such as Harlem and Washington
    Heights.  Moreover, as an academic medical facility, NYPH often performs
    extremely specialized and high-risk procedures for patients with diseases
    that community hospitals lack the expertise or resources to treat.  For
    instance, NYPH serves as the burn center for the New York City Fire
    Department, and cares for numerous patients who have received an organ
    transplant.  Each of these patient groups is inherently vulnerable to the
    threat of elevated HAI rates due to the use of immunosuppressant medications,
    which would require risk adjustment prior to being reported, so as to allow
    meaningful comparison to other patient groups and facilities.
            Furthermore, without effective risk adjustment to correct for these
    disparate patient populations and acuity levels, it would be quite
    challenging to generate a meaningful comparison between HAI rates at academic
    medical centers (and other tertiary hospitals), with the rates observed at a
    typical community medical center.  Moreover, in some situations it has become
    increasingly difficult to identify whether an infection was acquired while at
    the hospital, or within the community (e.g., the current epidemic of
    community-associated MRSA infections).  Risk-adjustment of outcome measures
    therefore is critical, because it enforces the validity of inter-hospital
    comparisons and addresses the issue of whether an infection likely was
    acquired during or prior to a patient's hospital stay.
            Unfortunately, the risk adjustment methods currently available are
    limited in their ability to account for differences in patient population and
    acuity levels among facilities.  As noted in the HICPAC report, "current risk
    adjustment techniques improve but do not guarantee the validity of
    inter-hospital comparisons, especially comparisons involving facilities with
    diverse patient populations (i.e., community versus tertiary-care
    hospitals)."  Current risk adjustment procedures thus incorporate only a
    portion of all potential confounding variables, and as such they are limited
    in their ability to correct for variability among data collectors in the
    accuracy of locating and reporting events.
            Unadjusted or poorly-adjusted HAI rates may lead to unintended and
    undesirable public health consequences.  For example, a patient
    misinterpreting HAI data may avoid seeking treatment at a particular
    facility, despite its being more experienced and better-equipped to treat
    the patient's condition.  And as noted above, with reimbursement rates
    increasingly becoming tied to outcomes, the public reporting of HAI rates
    may lead to decreasing reimbursements from third-party payors and a loss of
    patient revenues at facilities with higher infection rates.
            Given this lack of uniformity in the current HAI methodologies for
    collecting data, calculating rates, and adjusting for risk, facilities that
    publicly report also may face undue negative publicity and misplaced legal
    liability, each of which would undermine efforts to serve patients and their
    communities.  In the absence of a consensus for definition, measurement,
    data capture and denominator consistency, the release of current data may
    misrepresent the HAI environment to the public.
            In order for the public reporting of HAI rates to achieve the
    Committee's objectives - to improve hospital performance, and to provide
    patients and their families with educated decision making tools - such rates
    should be reviewed and adjusted for, among other considerations, acuity level
    and patient mix.  Moreover, the federal and state reporting agencies should
    remind consumers that HAI rates are not to be viewed in isolation.  Consumer
    interest groups and professional associations also play a role in the
    process to educate patients and their families about the benefits and
    limitations of HAI data.  In the end, the public should understand that HAI
    rates represent only one of a myriad of factors to be used in deciding where
    to receive quality healthcare.
            Thank you, Mr. Chairman, and I would be pleased to answer any of
    your questions.

    	MR. WHITFIELD.  Thank you, Dr. Hammer, and Dr. Hanrahan, you
    are recognized for 5 minutes.
    DR. HANRAHAN.  Mr. Chairman, members of the committee, thank
    you for allowing me to speak today about a subject that is very
    important.
    	Those of us who work in infection control know how critical what
    we do is, and we wish that everyone would pay more attention to
    infection prevention.  Public disclosure may be one of the methods to get
    people to pay more attention to infection prevention.  The question is
    how to do it properly.
    	Ideally, all infections would be reported in order to get the most
    comprehensive picture of what goes on, but the problem is that you
    really do need standard definitions and adjustments for patient factors
    that contribute to the risk of infections.  Right now, we don't have
    precise and valid definitions and appropriate rate adjustments for all
    infections.  We have this for some.
    	In order for public reporting to provide useful information, clear
    definitions have to exist that can be followed by the people that are doing
    the surveillance, and this is really critical.  I can tell you of several
    instances where our infection control personnel have called the CDC to
    get guidance on some of the NNIS definitions, the National Nosocomial
    Infection Surveillance system, and we found out that the definitions that
    we were using were not exactly what they had intended.  And so it really
    is important to be unambiguous.
    	HICPAC, the Hospital Infection Control Practices Advisory
    Committee, has made recommendations for process measures to be used
    in addition to outcome measures.  They have recommended things like
    influenza vaccination rates, adherence to hand hygiene, and so on, and
    they have also recommended reporting of central catheter bloodstream
    infections and select surgical site infections, because these have the least
    ambiguous definitions.  They have also recommended standardized
    methods for case findings as well as validation methods to ensure
    accuracy and completeness of hospital reporting.  This is really critical so
    that hospitals that are doing the most complete case finding are not
    looking worse than hospitals that are actually doing less complete a job.
    	Influenza vaccination has been mentioned as one of the process
    measures for hospitals.  In theory, this is a really great idea, but in
    practice, this may not really work too well.  Let us keep in mind that
    influenza vaccine availability has been a perennial problem, and is going
    to continue to be so in the near future.  Sanofi Pasteur, one of the major
    suppliers for influenza vaccine in the United States, released a statement
    on February 1, 2006, regarding unprecedented demand for influenza
    vaccine for the coming flu season, 2006-2007, and acknowledged that it
    will be unable to supply influenza vaccines to all those who are
    requesting it.  There were people that were not even able to get through
    to place their order because their phone lines were so busy.  Our hospital
    was one of those.  Until sufficient influenza vaccine is available to all
    those individuals for whom it is recommended, this process may not be a
    useful measure.  In order to reduce infection risks in hospitals, the
    influenza vaccine supply problem has to be resolved for both patients
    and healthcare workers.
    	NNIS is currently the method by which hospitals benchmark their
    hospital-acquired infection data.  This system was established in order to
    track the incidence of hospital-acquired infections and the risk factors for
    these infections.  NNIS does adjust for risk factors to an extent, but the
    risk stratification may not be sufficient.  For example, NNIS publishes
    benchmark data for infection rates in surgical intensive care units.
    Surgical intensive care units vary a great deal as to whether they are
    taking predominantly patients who have had elective surgery or people
    who have had trauma.  Trauma patients can differ a great deal, depending
    on what the mechanism of injury is, whether you are dealing with blunt
    trauma related to motor vehicle accidents, industrial accidents, gunshot
    wounds, stab wounds, et cetera.  Trauma patients with severe injuries are
    at higher risk for infections because of the nature of the trauma itself, and
    their hospital stays are often long and they usually include numerous
    procedures.  The risk of infection in these patients is different than the
    risk of infections in a patient undergoing elective or emergency surgery,
    and should not be grouped together.  However, the current NNIS
    definition for trauma intensive care unit includes those surgical intensive
    care units where 80 percent of the bed days consist of trauma patients.
    The hospital that I work in is the major trauma center in northeast Ohio.
    When a really bad accident happens on the news, I know that if that
    patient survives that accident, I am going to be seeing them at some
    point.
    	Our surgical intensive care unit typically has about 70 percent bed
    occupancy from trauma patients.  That means that our rates are compared
    to community hospitals that have surgical intensive care units who are
    not caring for trauma patients.  This is clearly inappropriate and really
    does not yield a valid comparison.  Methods to control for this need to be
    instituted prior to public reporting.
    	The last item that I want to mention is C.diff colitis, clostridium
    difficile colitis, which is an infection that has been in the news a great
    deal.  Currently, there is a hypervirulent strain of this organism in
    hospitals throughout the United States, Canada, and Europe, and this
    disease is causing a great deal of morbidity and mortality.  C.diff can be
    transmitted in hospitals on the hands of healthcare workers and from
    contaminated surfaces.  There has been demand for public reporting of
    this infection, and currently is a reportable infection in the State of Ohio.
    	Public awareness has been somewhat good in that it has led to
    increased awareness among healthcare workers, and I have seen
    increased attention to infection control precautions and hand washing.
    The problem with this infection is that currently there is no standard
    definition that is used by all hospitals to collect data, so you can't
    compare the rates that we are reporting in Ohio to other places that are
    reporting.  For example, Quebec is one of the places that initially noticed
    this outbreak.  You cannot make the comparison because we are not
    using the same definitions.
    	It is often not possible to determine where C.diff originated.  One of
    the problems is that patients may be hospitalized in several different
    hospitals and long-term care facilities over a period of months.  While
    C.diff is often a healthcare-acquired infection, the location where an
    individual became exposed is often difficult to determine.  In our
    institution, many of the C.diff cases that we see were acquired elsewhere.
    Currently, there is no standard definition that allows for complete
    reporting of all of the cases in Ohio.
    	There are potential adverse effects from public reporting.  The
    process of public reporting should be carefully thought out in order to
    avoid these consequences.  The HICPAC guidelines list potential
    diversion of resources from infection control education and prevention,
    disincentives for hospitals and healthcare workers to treat patients at
    higher risk for infection, as well as a potential for dissemination of
    misleading information if public reporting is not well planned.
    	I will stop there.  Thank you.
    	[The prepared statement of Dr. Jennifer Hanrahan follows:]

    PREPARED STATEMENT OF DR. JENNIFER HANRAHAN, D.O., CHAIRPERSON, INFECTION
    CONTROL COMMITTEE, METROHEALTH MEDICAL CENTER

                                      Summary
            Hospital-acquired infections are a major problem in the United
    States, and are one of the most common complications of hospitalization.
    Infections develop as a consequence of hospital factors and patient factors.
    Factors related to healthcare worker behavior and hospital systems can be
    changed, while patient factors often cannot be changed. Public reporting of
    hospital-acquired infections has the potential to impact infection rates by
    increasing awareness among healthcare workers and patients, and by increasing
    adherence to infection control measures.  In addition, public reporting has
    the potential to allow comparison of infection rates between institutions if
    it is done properly.  One of the problems with hospital-acquired infections
    is that the definitions currently being used by infection control are not all
    precise and uniformly applied.  This means that comparison between
    institutions using current definitions may not be valid.  There are
    infections for which definitions are more precise, and these include select
    surgical site infections and central catheter-related bloodstream infections.
    In addition to using precise definitions for infections, risk adjustment is
    necessary to account for different patient populations.  Hospitals that serve
    patients with a greater severity of illness are expected to have higher
    infection rates due to patient factors.  Risk stratification as performed by
    the National Nosocomial Infection Surveillance System may not be sufficient
    to account for the differences in patient populations.

    	Hospital-acquired infections are a major problem in the United
    States, and elsewhere throughout the world where healthcare is available.
    These infections constitute one of the most common complications of being
    hospitalized, and lead to a great deal of morbidity and mortality.1,2
    Some of these infections are preventable, and there are steps that can be
    taken by both healthcare workers and patients to decrease infection rates.
    In recent years there has been increasing discussion about mandatory public
    reporting of healthcare-acquired infections.  A number of states currently
    mandate reporting or have pending legislation regarding this issue.  Should
    public reporting be mandated?  The answer to this is an unequivocal yes.
    Public reporting has the potential to increase awareness and accountability,
    and may lead to increased attention to infection control measures by
    healthcare workers.  It may lead to increased funding for hospital infection
    control personnel, and anyone working in infection control would welcome
    this change.
    	Public reporting has the potential to give patients and families
    important information about risks of hospitalization and surgical procedures.
    In an ideal world, people would be able to make informed decisions about
    where to get healthcare, and would be able to understand the differences
    between healthcare institutions.  Public reporting should allow comparison
    between different types of hospitals, and should allow for direct comparisons
    of specific types of infection rates.  The challenge before you is to decide
    how public reporting should take place so that it gives people this kind of
    useful information.
    	One of the difficulties in deciding how to proceed is determining
    which types of infections should be reported.  Ideally, all infections would
    be reported in order to give the most complete picture. However, this would
    require standard definitions and clearly-defined methods to adjust for patient
    factors that contribute to the risk of infection.  In 2002, Dr. Gerberding
    described the following characteristics as desirable for characterizing
    hospital-acquired infections,	"Precise and valid definitions of infection-
    related adverse events, standardized methods for detecting and reporting
    events, confidentiality protections, appropriate rate adjustments for
    institutional and case-mix differences, and evidence-based intervention
    programs...3  All of these characteristics are desirable and would facilitate
    reporting of hospital-acquired infections. The problem is that precise and
    valid definitions and appropriate rate adjustment do not exist for all
    infections.  Current legislation for public reporting includes language
    about adjusting for risk factors for infection. The Society for Healthcare
    Epidemiology of America states the following in their position paper on
    public disclosure, "Although the language in these laws may be appropriate,
    unfortunately, there is currently no widely agreed upon, scientifically
    validated method for risk adjusting healthcare-acquired infection
    indicators."4
    	In order for public reporting to provide useful information,
    clear definitions must exist that can be followed by infection control
    personnel throughout the United States.  The Hospital Infection Control
    Practices Advisory Committee (HICPAC) outlined the essential elements of a
    public reporting system.5   The first step involves identifying appropriate
    measures of health care performance. HICPAC recommends inclusion of
    process measure because these can be followed in a variety of healthcare
    settings, and do not depend on adjustment for patient risk factors.
    Examples of process measures include influenza vaccination rates, adherence
    to hand hygiene, adherence to surgical antibiotic prophylaxis, etc.  HICPAC
    also recommends inclusion of outcome measures, meaning specific types of
    infections.  These outcome measures must have unambiguous definitions, and
    because of this, not all hospital-acquired infections should be included in
    public reporting.  HICPAC recommends reporting of central catheter-related
    bloodstream infections and select surgical site infections.  These infections
    have the most unambiguous definitions, and require less interpretation by
    infection control personnel.  Standardized methods for case-finding are
    recommended, as well as validation methods to ensure accuracy and
    completeness of hospital reporting.  Validation is critical to ensure
    that infections are comparable from hospital to hospital, and to ensure
    that some hospitals do not report less than others because their
    case-finding is less complete.
    	Influenza vaccination has been recommended as a process measure for
    hospitals.  In theory this is a great idea.  This should be easy to measure,
    and should be easy to replicate between hospitals.  However, influenza
    vaccine availability has been a perennial problem in recent years, and
    promises to continue being a problem.  Sanofi Pasteur, one of the major
    suppliers for influenza vaccine in the United States, released a statement on
    2/1/06 regarding an unprecedented demand for influenza vaccine for 2006-2007,
    and acknowledged that it will be unable to supply influenza vaccine to all of
    those who are requesting it.  Until sufficient influenza vaccine is available
    to all of those individuals for whom it is recommended, this process measure
    may not be useful.  One of the problems in the last few years has been that
    influenza vaccine has arrived too late in the season to be useful.  It is
    difficult to convince healthcare workers to get vaccinated once the annual
    epidemic has occurred.  Influenza vaccine supply problems should be resolved
    prior to implementing this as a process measure.
    	In choosing outcome measures, infections for which clear definitions
    exist should be included. Hospital-acquired pneumonia is an example of an
    infection for which substantial problems with definitions exists. One of the
    problems with using healthcare-acquired pneumonia as an outcome measure, is
    that definitive diagnosis is difficult.  According to 2005 guidelines of the
    American Thoracic Society and the Infectious Disease Society of America, "the
    diagnosis of hospital-acquired pneumonia is difficult, and most studies have
    involved clinical diagnosis, with sputum culture, but bronchoscopy has been
    used less often, making the reliability of the bacteriologic information
    uncertain and the specificity of the diagnosis undefined." 6 A number of
    different clinical criteria and diagnostic criteria have been proposed for
    the diagnosis of hospital-acquired pneumonia, and still no clear definition
    exists.  Infection control personnel currently use a definition that includes
    a number of clinical criteria, and leaves too much room for interpretation.
    These definitions are useful to individual institutions in that they can be
    used to follow trends over time for an individual hospital.  However, valid
    comparisons to other hospitals would be difficult, as individuals performing
    surveillance may interpret the definitions differently.
    	The National Nosocomial Infections Surveillance System (NNIS) is
    currently the method by which hospitals benchmark their hospital-acquired
    infection data.  This system was established in order to track the incidence
    of hospital-acquired infections and the risk factors for these infections.
    NNIS does adjust for risk factors to an extent, but the risk
    stratification may not be sufficient.  For example, NNIS publishes benchmark
    data for infection rates in surgical intensive care units.  Surgical intensive
    care units may vary substantially in patient populations.  These intensive
    care units may care for critically ill surgical patients and for trauma
    patients.  Trauma patients may have had a variety of injuries such as blunt
    trauma related to motor-vehicle accidents, industrial accidents, gunshot
    wounds, etc.  Trauma patients with severe injuries are at higher risk for
    infections because the nature of the trauma itself may lead to infection,
    and their hospital stays are often long and include numerous procedures.
    The risk of infection in these patients is different than the risk of
    infection in a patient undergoing elective or emergent surgery, and should
    not be grouped together.  However, the current NNIS definition for a
    trauma intensive care unit includes those surgical intensive care units where
    80% of the bed days consist of trauma patients.  The hospital that I work
    in is the major trauma center in Northeast Ohio.  We care for critically ill
    trauma patients with multiple injuries, and serve as a referral center for
    critically ill medical and surgical patients.  Our surgical intensive care
    unit typically has about 70% bed occupancy from trauma patients.  That
    means that our surgical intensive care unit is compared to other surgical
    intensive care units that do not care for predominantly trauma patients for
    NNIS benchmarking purposes.  Because of the severity of the injuries that our
    trauma patients have, comparison to other non-trauma intensive care units does
    not yield a valid comparison.  Methods to control for this need to be
    instituted prior to public reporting.  Case-finding methodology for NNIS is
    also costly and definitions are complex and may be difficult to
    apply.1
    	Clostridium difficile colitis (C.diff) is another infection that has
    received a great deal of attention recently. This infection is caused by
    bacteria that may be part of the normal bacterial flora in the intestines,
    and can manifest as an infection after exposure to antibiotics.  Currently
    there is a hypervirulent strain of this organism in hospitals throughout the
    United States, Canada and Europe, and this disease has caused a great deal
    of morbidity and mortality.  There have also been isolated cases of this
    disease occurring in individuals not previously exposed to antibiotics, which
    is unusual for this infection.  C.diff can be transmitted in hospitals on the
    hands of healthcare workers and from contaminated surfaces.  There has been
    demand for public reporting of this infection, and currently this is a
    reportable infection in the state of Ohio. The public awareness has led
    to increased awareness among healthcare workers, and I have seen increased
    attention to infection control precautions and handwashing.  The problem with
    this infection is that currently there is no standard definition that is used
    by all hospitals to collect data regarding rates of infection.  For public
    reporting to be most useful, there should be a standard definition followed
    be hospitals throughout the United States that would allow valid comparisons.
    The current definition being used in Ohio does not account for all
    cases of C. diff, and is different than the surveillance definitions that
    were previously being used by hospitals.  It is often not possible to
    determine where C.diff originated.  One of the problems is that patients may
    be hospitalized in several different hospitals and long-term care facilities
    over a period of months.  While C.diff is often a healthcare-acquired
    infection, the location where an individual became exposed is often difficult
    to determine.  In our institution, many of the C.diff cases that we see were
    acquired elsewhere.  Currently there is no standard definition that allows
    for complete reporting of all of the cases.
    	There are potential adverse effects from public reporting.  The
    process of public reporting should be carefully thought out in order to avoid
    these consequences.  HICPAC states the following:

    	Conversely, as with voluntary private reporting, mandatory public
    reporting that doesn't incorporate sound surveillance principles and
    reasonable goals may divert resources to reporting infections and collecting
    data for risk adjustment and away from patient care and prevention; such
    reporting also could result in unintended disincentives to treat patients at
    higher risk for HAI. In addition, current standard methods for HAI
    surveillance were developed for voluntary use and may need to be modified
    for mandatory reporting. Lastly, publicly reported HAI rates can mislead
    stakeholders if inaccurate information is disseminated. Therefore, in a
    mandatory public report of HAI information, the limitations of current
    methods should be clearly communicated within the publicly released report.5

            These potential adverse consequences must be carefully considered in
    the implementation of public reporting.  A system that diverts infection
    control personnel from surveillance and education of healthcare workers could
    have the unintended consequence of increasing hospital-acquired infections.
    	In conclusion, public disclosure of hospital-acquired infections has
    the potential to make useful information available to the public, and may
    lead to improvement in quality of healthcare in the United States.  In order
    for the public to get useful information that allows valid comparisons
    between hospitals, the process and outcome measures must be carefully
    considered, and it is imperative that definitions exist that can be applied at
    hospitals throughout the country.  Further, there need to be methods to
    validate reported information, and adequate personnel so that reporting does
    not detract from current infection control responsibilities.

    References
    1.	Burke JP. Infection control - a problem for patient safety. N Engl J
    Med. 2003 Feb 13;348(7):651-6.
    2.	Weinstein RA. Nosocomial infection update. Emerg Infect Dis
    1998;4:416-420.
    3.	Gerberding JL. Hospital-onset infections: a patient safety issue.
    Ann Intern Med. 2002 Oct 15;137(8):665-70.
    4.	Wong ES, Rupp ME, Mermel L, Perl TM, Bradley S, Ramsey KM, Ostrowsky
    B, Valenti AJ, Jernigan JA, Voss A, Tapper ML.  Public disclosure of
    healthcare-associated infections: the role of the Society for Healthcare
    Epidemiology of America. Infect Control Hosp Epidemiol. 2005
    Feb;26(2):210-2.
    5.	McKibben L, Horan T, Tokars JI, Fowler G, Cardo DM, Pearson ML, Brennan PJ; Healthcare Infection Control Practices Advisory Committee.
    Guidance on public reporting of healthcare-associated infections:
    recommendations of the Healthcare Infection Control Practices Advisory
    Committee. Am J Infect Control. 2005 May;33(4):217-26.
    6.	American Thoracic Society; Infectious Diseases Society of America.
    Guidelines for the management of adults with hospital-acquired, ventilator-
    associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med.
    2005 Feb 15;171(4):388-416.

    	MR. WHITFIELD.  Dr. Hanrahan, thank you.
    	Dr. Daley, you are recognized for 5 minutes.
    DR. DALEY.  Thank you for inviting me here today, Chairman
    Whitfield and Congressman Stupak and other members of the committee.
    I both appreciate the opportunity to address you and also compliment
    you for your interest in this issue, which is a passion for all of us here on
    the panel.
    	I am the Senior Vice President for Clinical Quality and the Chief
    Medical Officer for Tenet Healthcare Corporation based in Dallas,
    Texas.  I have had that position since July of 2003.
    	Since joining Tenet, I have collaborated with my boss, who is the
    CEO of Tenet Healthcare, Trevor Fetter, to develop a new quality
    program for all of our hospitals, which is called the Commitment to
    Quality.  Its sole purpose is to bring evidence-based practices to improve
    safety and quality for all our hospitals.  One of the critical components of
    that is reducing hospital-acquired infections.
    	We have endorsed two goals.  Our primary one is to reduce the
    incidence of these infections to zero, and the second is to share accurate
    data with our patients and our consumers.
    	One critical component of our infection control program is the
    creation of a web-based system that allows us to identify every hospital-
    acquired infection in every hospital concurrent with the patient's
    hospitalization.  If you went to almost any hospital in the United States
    and asked to meet the hospital infection control person, you would find
    them in the basement, somewhere distant from healthcare, collecting data
    on patients from six months ago.  This allows our infection control
    practitioners to, every morning when they come to work, identify all the
    hospital-acquired infections for that day and get out on the floors within
    a matter of an hour to start preventing the next infection.
    	We have taken the philosophical approach that every hospital-
    acquired infection should be taken as an opportunity to review the root
    causes and to change our approaches to proactive prevention so that we
    can prevent any subsequent infection.  This system also produces
    comparative reports across our hospitals, and secondarily, while we have
    done that for comparative reasons, it has also given us the ability to
    develop incentives toward achievement of our goal of zero infections.
    	So my boss, Mr. Fetter, and I have collaboratively developed
    something known as the balance scorecard, which puts significant weight
    on improvement in quality and safety, and in 2006, all executive
    compensation calculations for bonus in Tenet include a component for
    reducing the rate of hospital-acquired infections with our own form of
    paper performance.
    	We also want to provide reliable and credible information to the
    public and our patients.  We believe in being transparent with our
    patients and their families, as well as our physician and payer partners,
    about the quality and safety in our hospitals and who benefits from them,
    and that is a reinforcement of our commitment to quality.
    	As everyone has noted on the panel, State legislatures are stepping
    up to this plate in an aggressive way, and we support that.  I personally
    have a concern that the State experiments will result, in my case, where
    we provide healthcare in 13 different States, that I will have 13 different
    reporting requirements to incorporate into my systems.  That presents
    somewhat of a burden to us as a national healthcare company.  I would
    prefer to see standard definitions, strategies for surveillance and
    identification, and reporting of hospital-acquired rates.  If you decide that
    that single approach is in the best interest of the country, I would
    encourage you to examine what the NQF is doing.  I am a little more
    optimistic than some of my panel members that we will have both
    process and outcome measures come out of that.
    	I think we can do this.  In a life prior to my life at Tenet, I was the co-chair of the National Surgical Quality Improvement Program in the
    VA.  We were able to reduce in major surgery in the VA the
    complication rates which primarily consisted of surgical site infections,
    ventilator-associated pneumonia, and central line infections by 50
    percent, and those have continued to drop subsequently.  We saw a 25
    percent decrease in the number of deaths related to surgery in the VA,
    and as you know, it is now recognized as one of the best high-quality
    healthcare systems in the United States.
    	On the issue of risk adjustment, in a former life with my colleagues
    at Harvard, we wrote three books about risk adjustment.  I think we have
    to explore this very carefully because there are some populations of
    patients, you mentioned trauma patients, you mentioned burn patients
    and immuno-compromised patients, like Congressman Ferguson's
    mother, where we do need to understand whether they are at higher risk
    and how we can mitigate those risks.
    	We take this issue extremely seriously.  We are absolutely
    committed to quality healthcare that is both effective and safe.  Let me
    reiterate that we at Tenet are willing to cooperate in any way that we can
    and to implement the best standards for reducing the incidence of
    hospital-acquired infections.  We do know how to reduce the incidence
    of these infections, and indeed eliminate them.  The evidence exists.
    Those of us in this profession know what bundles are.  For reducing
    ventilator-associated pneumonia, there are five things that you can do
    that work.  There is a bundle for every single one of the things that we
    are talking about.  We can do this.
    	Thank you again for the opportunity to speak to you, and for your
    commitment in making care safer for all our patients.
    	[The prepared statement of Dr. Jennifer Daley follows:]

    PREPARED STATEMENT OF DR. JENNIFER DALEY, MD, SENIOR VICE PRESIDENT AND CHIEF
    MEDICAL OFFICER, TENET HEALTHCARE CORP.

            Chairman Whitfield, Congressman Stupak, Subcommittee members:
            I thank you for inviting me to appear today before the Subcommittee.
            I am the Senior Vice President of Clinical Quality and Chief Medical
    Officer for Tenet Healthcare Corporation, headquartered in Dallas, Texas.  I
    have served in this capacity since July 2003.  Prior to joining Tenet, I was
    the Director of the Center for Health Systems Design and Evaluation at
    Massachusetts General Hospital and an Associate Professor of Medicine at
    Harvard Medical School.  Tenet Healthcare owns and operates 69 acute care
    hospitals in 13 states, including four leading academic medical centers and
    one children's hospital.
            Since 1990, I have been researching and applying quality improvement
    activities in hospitals and am proud today to oversee Tenet's commitment to
    improving the areas of quality of care and patient safety in our hospitals.
    Since joining the company, I have worked with CEO Trevor Fetter to develop and
    implement a new quality program for our hospitals known as the "Commitment to
    Quality," which is designed to enhance the overall quality and productivity of
    our care delivery process.  The Commitment to Quality consists of a
    comprehensive set of initiatives all aimed at one purpose: to utilize
    evidence-based medicine and demonstrable best practices across a large
    hospital system to improve clinical outcomes and patient safety.  The
    initiatives focus on quality of care and patient safety, nursing practice,
    medical staff governance and other important areas related to patient care.
            I am pleased to be able to speak with you today about an important
    component of our Commitment to Quality and a critical challenge facing the
    nation's healthcare system - reducing the incidence of hospital-acquired
    infections ("HAIs").  I would like to begin by emphasizing the fact that
    Tenet endorses two goals, the most important of which is reducing the
    incidence of HAIs, and the second of which is sharing accurate and useful
    information about infection control efforts with patients and the public.
    	Tenet's commitment to reducing the incidence of HAIs and resultant
    infections in our own hospitals is evidenced by several aggressive programs
    implemented by Tenet.  Our infection prevention and control efforts focus on
    four main categories of HAIs: surgical site infections, ventilator-associated
    pneumonia, central venous catheter-associated bloodstream infections, and
    urinary catheter-induced urinary tract infections.  We are also targeting
    infections resulting from antibiotic resistant strains of bacteria, such
    as methicillin-resistant Staphylococcus aureus ("staph" bacteria/infection),
    vancomycin-resistant Enterococci (VRE), and Clostridium difficile (colitis).
    	In mid-2005, Tenet issued a Model Infection Control Program Plan as
    a framework to assist our hospitals in the development of hospital-specific
    infection control and prevention programs.  The model plan, a copy of which
    has been provided to the Subcommittee, is designed to meet the 2005 regulatory
    requirements from the Centers for Medicare and Medicaid (CMS) Conditions of
    Participation and the 2005 Joint Commission on Accreditation of Healthcare
    Organizations (JCAHO) Standards for Practice.  The plan also takes into
    account the position statements for the infrastructure and essential
    activities of infection control and epidemiology in hospitals from the
    Society for Healthcare Epidemiology of America (SHEA) and the Association for
    Professionals in Infection Control and Epidemiology (APIC).  In distributing
    the model plan, Tenet advised our hospitals that notwithstanding the fact that
    they might have existing policies, those policies at the very least were to
    be modified to include all components of the model plan.
    	The basic purpose of Tenet's extensive Infection Control Program
    Plan is to actively identify infections and reduce the risk of disease
    transmission through the introduction of proactive preventive measures.  We
    at Tenet recognize that effective infection control programs no longer
    consist of generating incident infection reports from a cubicle in the
    hospital basement.  Superior infection control programs require a systematic
    approach, including the adoption of specific infection control procedures
    and efforts to ensure compliance with those procedures.  Tenet's infection
    control program exemplifies this high standard and includes the creation of
    an Infection Control Committee, provisions for risk assessment, and numerous
    specific strategies for preventing infection.  Moreover, Tenet's own infection
    control program, coupled with our participation in the "100,000 Lives
    Campaign," provide effective and uniform standards across all 69 of Tenet's
    hospitals.  Local variations in infection control programs, within Tenet's
    hospitals, are being eliminated as Tenet strives to create a unified set of
    the highest infection control standards.
            As previously stated, in addition to implementing our own, very
    rigorous and uniform Infection Control and Prevention Plan as part of an
    effort to reduce the occurrence of HAIs, Tenet and all of its hospitals were
    founding members of IHI's "100,000 Lives Campaign."  The overall goal of the
    Campaign, consistent with Tenet's infection control program goal, is to make
    healthcare safer and more effective to ensure that hospitals achieve the best
    possible outcomes for all patients.  Like Tenet's infection control program,
    the campaign implements specific targets which aim to reduce or prevent
    infection in hospitals.
            A critical component of Tenet's approach to infection control is the
    company's creation of an internal system of reporting the incident-rate of
    HAIs in our hospitals.  This system, which is currently being implemented,
    produces comparative reports of HAIs within Tenet and will be an effective
    tool in improving the quality of care and patient safety in all of Tenet's
    hospitals.
            Finally, I know that the Subcommittee, others in Congress, and
    officials at CMS are exploring mechanisms by which "pay for performance" can
    be used to provide incentives for improving quality among healthcare
    providers.  Since assuming leadership of Tenet in 2003, Trevor Fetter has
    spearheaded the development of an innovative compensation program for
    corporate and hospital executives, know as the Balanced Scorecard, which
    places significant weight on achieving quality improvement goals.  This year,
    and for the first time, success in reducing the rate of HAIs in Tenet
    hospitals will be a significant factor in all executive compensation
    calculations.  This change will affect all levels of executive management,
    including Trevor himself.
    	In addition to Tenet's and my primary goal of reducing HAIs, it is
    also our goal to ensure that reliable information is properly disseminated to
    patients and the public.  Getting information to consumers not only allows
    them to make informed decisions about their healthcare, but more importantly,
    it enables hospitals to analyze their own infection control methods and see
    what is working effectively to reduce the incidence of HAIs and what areas of
    infection control need improvement.
            Recently, state legislatures have taken aggressive steps to ensure
    that public reporting of HAIs becomes a priority.  As it currently stands,
    more than thirty states have passed or are considering legislation regulating
    the reporting of HAIs.  Three of the states in which Tenet owns or manages
    hospitals currently mandate the public reporting of HAI rates: Pennsylvania,
    Missouri and Florida.  Over the next year, four additional states in
    which Tenet operates hospitals will consider implementing public reporting
    requirements of HAI rates: California, Alabama, Georgia and Mississippi.
    Finally, three states in which Tenet operates hospitals currently have study
    bills: Texas, Tennessee and Louisiana.
    	While it is our goal to see that data related to hospital infection
    rates are collected and accurately publicly reported, it is critical to point
    out that not all reporting methods will necessarily be helpful or effective.
    The legislation varies among states, creating the very real possibility that
    Tenet and other national healthcare providers will be subject to multiple and
    varied reporting requirements and methodologies.  Some state legislation
    requires reporting according to specific procedures, and different states may
    require reporting for different procedures.  Individual state legislation also
    varies according to the particular type of HAI for which reporting is
    required.  State legislation can also vary according to the type of healthcare
    facility in which infection occurs, such as critical care units, hospitals,
    ambulatory surgical centers, and nursing homes.  With such varied approaches
    to reporting requirements among several states, following each state's law
    accurately will create a significant burden for national healthcare providers
    such as Tenet.
    	Because of the difficulty and burden inherent in having different
    reporting requirements, there would be some benefit to establishing a single
    national standard for the identification, definition and reporting of HAI
    rates, provided that the single standard is established after thoughtful and
    collaborative evaluation.  If it is decided that a single standard is the
    best approach, I would encourage Congress to examine current industry
    efforts to establish reporting requirements.  One good example of such an
    effort is the National Quality Forum ("NQF") expert panel, currently being
    formed by the NQF.  Members of the National Societies of Hospital
    Epidemiologists (SHEA and APIC), as well as representatives from the CDC,
    will be represented on this panel.  I believe this group is capable of
    arriving at scientifically sound and feasible methods and definitions
    that will serve as reasonable national references and standards.
    	In addition to establishing a reasonable national standard, the NQF
    panel is in the best position to make recommendations on how to adjust for a
    higher baseline risk of infection in acute care units.  Currently, Tenet has
    several hospitals with high patient acute care units, such as trauma units
    and burn units, in which the baseline risk of HAIs is higher than in many
    intensive care units and general medical/surgical units.  Appropriately
    adjusting for this higher baseline of risk of infection in critically ill
    patients would ensure that the information provided to public consumers is
    more useful and accurate.
    	Hospitals across the country are taking the issue of HAIs and
    resultant infections very seriously and increasing their efforts to combat
    this problem.  I am particularly proud of Tenet's work on implementation of
    infection control and prevention plans in all of our 69 hospitals and our
    participation in the IHI's "100,000 Lives Campaign," which provide strong
    examples of industry efforts to reduce the incidence of HAIs and resultant
    infections.  With industry cooperation and increased awareness of the issues
    created by hearings such as this, the healthcare industry can further our
    dual goals of reducing the incidence of HAIs and disseminating accurate and
    useful information to patients and the public.
            Tenet is absolutely committed to quality healthcare that is both
    effective and safe for patients.  As part of this commitment, let me
    reiterate that Tenet is willing to cooperate to help establish the best
    standards for reducing the incidence of HAIs and for public reporting of
    HAI rates.  Thank you again for the opportunity to speak with you today.

    	MR. WHITFIELD.  Dr. Daley, thank you, and thanks to the entire
    panel.  We appreciate it very much.
    	Dr. Daley mentioned these risk adjustment factors, Dr. Hanrahan
    certainly referred to them, and Dr. Hammer referred to them.  In my brief
    involvement in this issue, it appears that risk adjustment factors continue
    to be an area that creates quite a bit of concern by a lot of people.
    	Dr. Haley, you heard Dr. Hammer and Dr. Hanrahan and their
    discussion about risk adjustment factors, Dr. Shannon, you also.  Would
    you comment on the concerns that they had, and then I would like for
    you all to comment on what they say as well.
    	DR. HALEY.  I think it has to do with where you use the data, and I
    think Dr. Shannon's comments were appropriate.  In the hospital when
    you are trying to incent doctors and nurses to be more careful and so
    forth, looking at numbers of infections is good.  In fact, at Parkland, we
    have a chart where we look at the risk adjusted rates and the numbers and
    all of that on the same graph, and we share that information.
    	On the other hand, when you are trying to put up a website where
    you have data that consumers are going to look at, and presumably it is
    there so they can make a decision which hospital to go to.  If you don't
    risk adjust the data, chances are the hospital with the lowest infection
    rate is going to be the one that takes care of the least acute patients, the
    wellest patients, and the ones with the highest rates are going to be the
    ones that take care of the sickest patients.  To some extent, that is
    unavoidable.  You can't reduce the surgical wound infection rates to
    zero.  No one has ever shown that you could ever do that.  And so if you
    don't risk adjust, that confounding is going to automatically send the
    patients to the ones with the lower rates, which are the ones that take care
    of the least acute patients, and you are looking at apples versus oranges.
    Whereas if you risk adjust, you might find that a big hospital that takes
    care of the most complicated patients actually does the better job when
    you risk adjust, and the patient would then go to the one with the higher
    rate because that is actually where they do a better job and prevent
    infection better.
    	So if you don't risk adjust, you are in the paradox of sending the
    patients to the place where they had the highest risk of infection.
    	MR. WHITFIELD.  All right.  Dr. Shannon, what comment do you
    have?
    	DR. SHANNON.  Briefly, I certainly would be willing to pull all of the
    burn unit patients out of public reports and compare them separately.  I
    would be willing to pull all the cancer center patients out of the public
    reports and compare them separately.  I would be willing to pull all the
    trauma unit patients out of the public reports and compare them
    separately.
    	In our experience in the 54 central line infections that I showed you,
    only one patient was immuno-compromised.  The most common
    diagnosis was heart failure, not a disease that I would say anyone would
    identify as at high risk for a line infection.  It is not diabetes; we have
    looked at this.
    	So I think we could pull out the high risk patients, and in the
    experience in Pennsylvania Mr. Volavka could comment, but of the
    11,668 reported infections, only 300 were in any of the high risk groups
    you have heard mentioned today, so what about the 11,300 other people
    that aren't in high risk groups?
    	So I would be willing, in deference to the risk adjustment, to take out
    of public reports, or compare separately, if that is what you want to do.
    But I think to hold up the process by virtue of waiting for an acceptable
    risk adjustment methodology to account for that is going to be a delay.
    	MR. WHITFIELD.  What about you, Mr. Volavka?
    	MR. VOLAVKA.  I can give you the numbers.  Dr. Shannon just gave
    them to you.  I would agree with all the panelists.  I would take issue
    with the framing of the concept of risk adjustment.  I don't believe it is
    appropriate to risk adjust.  I do believe it is inappropriate to exclude.  I
    would absolutely concede--and we had this argument--to trauma patients,
    burn victims, transplants.  I don't want to compare a community hospital
    that doesn't do burns, doesn't do trauma, doesn't do transplants with a
    hospital that does.  But we went in and actually looked at the data that
    was reported in Pennsylvania, and as Dr. Shannon indicated, of the
    11,668 patients that got an infection in Pennsylvania hospitals, that the
    hospitals put their hands up and said yes, we gave this patient an
    infection.  Less than 300 of them fell into any of those categories.  I will
    exclude them.  I don't want to risk adjust for them, I will exclude them.
    	Further, I think it would be very helpful to look at those patient
    populations in and of themselves, but that is an exclusion.  That is not a
    risk adjustment.  There were still 11,368 patients that fall into the
    category that don't fall into those major areas where I would agree it is
    not fair to compare a hospital that takes a lot of those patients with a
    hospital that doesn't.  So it is terminology.
    	MR. WHITFIELD.  Dr. Hammer, any comment?
    	DR. HAMMER.  I think what you are hearing is that there is more
    agreement here than disagreement.  That in fact, we are all in the
    business of improving patient care and improving quality at the same
    time, and it is a win/win situation, which was mentioned earlier, to
    reduce lengths of stay and to reduce hospital-acquired infections.
    	I personally think I would like a system that it more inclusive and
    risk adjusted than where we start carving out exclusions, because I think
    the country has many centers and many academic medical centers that
    take on these more complicated patients.  In fact, these more complicated
    patients--and I will be brief--are not as uncommon as we think.  Organ
    transplantation, for example, is a widespread issue across the Nation, and
    I think we have to keep those patients in the mix.  We just have to risk
    adjust and stratify properly for them.
    	I will defer to my colleagues on my left.
    	MR. WHITFIELD.  Any comment, Dr. Hanrahan?
    	DR. HANRAHAN.  Yeah, I agree.  It sounds like we actually all
    mostly agree on this.  I certainly am in favor of public disclosure.  I
    would like more people to pay attention to infection prevention, so I am
    very much in favor of it and I am not suggesting holding it up for
    purposes of risk adjustment, but I want to make sure we really are
    comparing apples to apples.
    	And so one of the things in our hospital, I can tell you in our medical
    intensive care unit and our cardiac intensive care unit, we have had zero
    catheter-related bloodstream infections since July of 2004.  That is not
    where we are seeing it.  We are seeing it in our trauma and burn patients.
    And so in our hospital, we have tried to implement some of the same
    things that we did to get our rates down in those other areas, and it has
    not been successful on the trauma patients.
    	And so I think that there are certain infections that you can't prevent.
    	MR. WHITFIELD.  Dr. Haley, I may have misunderstood you, but I
    had the impression in your testimony that you were saying we really
    didn't need a national system that the States could do this.  Yet, on the
    other hand, it does look like you get a patchwork of different systems,
    and if there was one area where Federal government should be involved,
    it would be in this area.
    	DR. HALEY.  Yeah, I think eventually that would be a good idea.  I
    just think at this point you see the disagreement over the nuts and bolts of
    how this should be done.  And I think we have seen like four Medicaid
    and other Federal areas, when you have States experimenting for a period
    of time, you get all kinds of different models.  Then over time, you learn
    about them, you have national meetings and scientific meetings where
    people debate it, and then two or three or four years from now, we might
    be in a position where you would want to have a national standard, or
    one might just evolve, if we all sort of agree on what needs to be done.
    	So I think to freeze it right now, before there is the experimentation,
    I think might reduce innovation.
    	MR. WHITFIELD.  Right.  What about you, do you agree with that,
    Ms. Goeschel?
    	MS. GOESCHEL.  I think that in Michigan we agree that transparency
    is important, but we think that overall, we dedicate far too many
    resources to debating how to report data versus how to eliminate
    infections.
    	And so when I started my testimony by saying we aren't about
    public reporting, we will report anything anyone wants, because we don't
    have the infections.  The reality is, we want to go about continuing to
    support getting rid of the infections, not laborious debate over how to
    report them.
    	MR. WHITFIELD.  In our exhibit book here, the HICPAC report
    warns that mandatory public reporting may have unintended
    consequences, such as diverting resources away from patient care and
    creating disincentives to treat high risk patients.  Do you all share those
    concerns?
    	DR. HALEY.  I don't.  I think what we are seeing in Missouri, for
    example, I was talking to them just the other day.  When they passed
    their law, suddenly hospitals started hiring a bunch of new infection
    control practitioners.  There was a big hiring frenzy going on.  So I think
    hospitals are responding responsibly when they see they are going to
    have to measure.
    	MR. VOLAVKA.  That is a great question.  It really is.  Before the
    Pennsylvania requirement went into business, the rumor was around the
    country that ICPs were already leaving Pennsylvania in droves.  The
    reality is that we have seen exactly what you are seeing, and quite
    frankly, because we have started to do some public disclosure of
    potentially under-reporting hospitals.  I can tell you, even as late as
    yesterday, I got a letter from a CEO who had been identified as a
    potential under-reporter, and quite frankly, that hospital is now
    undergoing an independent audit.  I won't tell you the nature of the
    conversation I had with him three weeks ago, but I will tell you what the
    letter said.  The letter said we are hiring additional ICP personnel to
    ensure that we meet the goals of public reporting.  It is happening all
    over.
    	I would like the opportunity to congratulate Michigan, number one.
    I think that is the ultimate goal.  I may be one of the few that actually has
    known about what has been occurring in Michigan.  I think Michigan is a
    shining example of where a hospital association is way out in front of the
    curve.  There are others in this country, and Texas is another one.  I
    know some Texas people in the hospital association very well.
    	MR. WHITFIELD.  Ms. Goeschel?
    	MS. GOESCHEL.  And I was just going to say, I think a key point, and
    hopefully it came through in my testimony, is that although there wasn't
    public reporting, we were all about measurement.  This is hard work and
    people pushed back in terms of how to define.  But the minute we
    created that these are the definitions, this is what we are doing, this is
    how we are going to collect, this became a learning community like no
    other.
    	And that is where the tough balance is, between is it reporting or is it
    eliminating the infections, and that is part of the debate.
    	MR. WHITFIELD.  And Dr. Daley, do you have any comment on this
    HICPAC report?
    	DR. DALEY.  I think it will create positive incentives for hospitals.
    	MR. WHITFIELD.  Okay.
    	DR. DALEY.  I am not worried about that at all.  The goal is to reduce
    infections.
    	MR. WHITFIELD.  My time is expired.  Mr. Stupak?
    	MR. STUPAK.  Thank you.
    	Ms. Goeschel, did Michigan have to hire all kinds of infection
    control officers?
    	MS. GOESCHEL.  To my knowledge, we did not hire.  I didn't hear
    anything about hiring infection control practitioners in droves.  What I
    will tell you is that the infection control community is highly involved in
    our project, extremely supportive, because the reality is every clinician in
    Michigan in ICUs is now an infection control practitioner.  The
    awareness of what we need to do to eliminate infections doesn't belong
    to infection control practitioners, it belongs to everyone.
    	MR. STUPAK.  Let me ask this question.  It came up earlier.  In your
    experience, and since you are all infection people you are probably tuned
    into it, but does the doctor, as a general rule, know the infection rate of
    the hospital he is licensed at?  Most of you are shaking your head no.
    	DR. HANRAHAN.  I can tell you that is definitely not the case at our
    hospital.
    	MR. VOLAVKA.  I can tell you further that when we have started to
    show them their infection rates, they get astounded and they engage.
    	DR. HALEY.  Now, remember, the majority of hospitals are not
    measuring, so if they don't measure, nobody can know the rate.
    	MR. STUPAK.  And even CDC only did less than 10 percent of the
    hospitals in the United States.
    	DR. HANRAHAN.  Can I just make a clarification?
    	We do get feedback to physicians about their infection rates, but
    somebody else, another physician is not going to know the hospital
    infection rates.
    	MR. STUPAK.  In surgery, one of the issues that came up today is
    infection in surgeries.  When you go to surgery, before you actually go to
    surgery, don't you get an antibiotic to try to prevent infection?  Isn't that
    sort of like standard operating procedure?
    	DR. HANRAHAN.  It depends what the procedure is.  It is not
    recommended for all surgical procedures.  For clean surgical procedures,
    there is no need, you know.  It really depends what you are talking about.
    If you are having--
    	MR. STUPAK.  Let us say Mr. Wagner's son here who had the broken
    humerus.  Would it have been--given him an antibiotic before--
    	DR. HANRAHAN.  You know, I don't want to comment specifically--I
    don't know the details of that case.
    	MR. STUPAK.  Right, but without knowing the details, isn't it sort of
    standard operating procedure?  Isn't there a protocol you have to follow?
    No?
    	DR. HANRAHAN.  Not unless there is going to be an implant.
    	DR. HAMMER.  I would just say that for an orthopedic procedure of a
    fracture as described, and I don't know the details, with metal implanted
    there would be a prophylactic antibiotic given.
    	DR. HALEY.  You know, there is a push-pull here, and there is huge
    scientific literature on this.  There are certain procedures where it is
    proven that prophylactic antibiotics reduce the infection rate.  There are
    others where it has been proven that they don't.
    	MR. STUPAK.  Sure.
    	DR. HALEY.  And if you give antibiotics on those, what you are
    doing is exposing the patient to the untold side effects of antibiotics,
    which can be very serious sometimes, with no prospect of gain.  And so
    surgeons are much better these days than they were 20 years ago in
    giving it in those cases where it is indicated and not giving it when it is
    not indicated.
    	MR. STUPAK.  Okay.  Dr. Daley, back in your testimony you said in
    your previous life, you worked at the VA and reduced infections by 50
    percent?
    	DR. DALEY.  We reduced post-operative complications, which were
    primarily post-operative infections, surgical site infections.  This was all
    from major surgery, ventilator-associated pneumonia, central line
    infections, by 50 percent.
    	MR. STUPAK.  Okay.  You probably didn't have definitions back
    then, so--
    	DR. DALEY.  Yes, sir, we did.  We used the CDC definitions.
    	MR. STUPAK.  Okay.  Why can't you do that at your hospital now, at
    Tenet?
    	DR. DALEY.  I am.  That is my goal in life.
    	MR. STUPAK.  Okay.  This is sort of a recent goal, right, because you
    just put financial rewards for compensation to reduce the--
    	DR. DALEY.  We have had the program since I arrived in July of
    2003.
    	MR. STUPAK.  Okay.
    	DR. DALEY.  We have got all the standard definitions in place, and
    now we have the standard web-based reporting system.  We put our
    hospital executives on notice that this was going to happen six months
    ago, and we pulled the trigger on January 1.
    	MR. STUPAK.  Of this year?
    	DR. DALEY.  My phone has been ringing off the hook.
    	MR. STUPAK.  Okay, that is good.  That is good.
    	DR. DALEY.  Yes, sir, it is.
    	MR. STUPAK.  Dr. Hanrahan, I got the impression you have a lot of
    reluctance about this public reporting, definitions of infections in trauma
    units, and risk situations that you seemed to be concerned about.  But
    what concerns your hospital--and I guess what I didn't hear is what is
    your hospital doing to reduce its own incidence of hospital-acquired
    infections?  For example, ventilator-associated pneumonia is one of the
    most deadly hospital infections, and in some simple steps such as I
    mentioned in my opening statement, elevating the head of the patient will
    reduce the incident.  But instead, in your testimony you sort of talked
    about lack of a flu vaccine.
    	So I guess my question is what is MetroHealth Medical Center doing
    to reduce this infection, or any other infection, regardless of how it is
    counted?
    	DR. HANRAHAN.  Thank you for giving me an opportunity to clarify
    that, because we certainly are doing a great deal, and I guess in my
    testimony today I really wanted to emphasize the things that I think are
    potential problems with public disclosure, not to just tell you what we
    have done to decrease our infection rates.  I will go into that in a
    moment.
    	But I want to clarify, I am not opposed to public disclosure, I am
    very much in favor of it.  I just think that it really needs to be done
    properly and it is incumbent upon all of you to make sure that this
    happens properly, otherwise it is not going to yield useful information.
    What is going on in Ohio right now with the C.diff reporting, I have
    serious concerns about and I think this is an example of where some of
    the information can potentially mislead people.  People are not getting all
    of the information about C.diff that they think they are getting.
    	So what our hospital is doing, what you mentioned about raising the
    head of the bed to prevent ventilator-associated pneumonia, we are doing
    those things.  The things that the IHI has recommended, and their
    100,000 Lives campaign, we are doing all of those things.  We have had
    excellent adherence to hand hygiene once HICPAC and CDC made the
    recommendation to change to alcohol-based hand hygiene products.  Our
    hand hygiene compliance rates have been upwards of 90 percent, which
    is unheard of when you compare it to lots of other studies that are being
    done.
    	MR. STUPAK.  Okay.  Have your infection rates been going down?
    	DR. HANRAHAN.  Yes.  For central line associated infections in
    certain intensive care units, as I said before, the infection rates have gone
    down.
    	MR. STUPAK.  Wouldn't you want that to be known then?
    	DR. HANRAHAN.  Sure.
    	MR. STUPAK.  I mean, I don't think the issue is what definitions we
    are using.  Isn't the real issue here reducing the infections?
    	DR. HANRAHAN.  No, I absolutely want that to be known.  My
    comment was regarding specifically the trauma patients, and I can tell
    you we have not been able to have that same impact in that patient
    population.  I think it is important to highlight that we really are talking
    about some different patient populations.
    	MR. STUPAK.  Well, let me ask Dr. Shannon this, because this patient
    population, I am not sold on that.  When we prepared for this hearing,
    our staffs spent a lot of time with several hospitals and the argument was
    made or talked about that because they were like inner city hospitals or
    teaching hospitals or trauma centers, that their patients were sicker than
    those in other hospitals, and as thus, more susceptible to infection than
    other patients in other hospitals.  So I guess I would ask Dr. Shannon, is
    it your view then that the patient should not get infections in the other
    hospitals or at a greater rate of risk than other patients?  I mean, I just
    think that is--
    	DR. SHANNON.  Yes, I believe that there isn't a differential rate of
    risk, except in biological circumstances in which we recognize the
    person has a predilection to those infections, immunosuppresion, burn
    patients, perhaps trauma patients.
    	I think this is not about biology and organisms.  This is about
    processes of care in which one places a catheter in an arm in a standard
    way and then guarantees it is going to be maintained in a sterile fashion
    for the period that it is in dwelling.  This has to do with educating
    operators that variations in the way to put in the line are not helpful to a
    process. Can't we, as intelligent people, agree that there is one way to
    place a subclavian line?  We don't--some of us gown, some of us don't,
    some of us glove, some of us don't, some wear caps, some don't.  Some
    nurses don't remain sterile when they hook the catheter up, some do.
    What we have done is standardized those processes so that at any
    moment, a variation can identify a potential harmful circumstance that
    might propagate into an infection.  So too, we have done the
    standardization around maintaining the catheter's integrity.  If the
    catheter is in for 12 days, focusing on the day it is placed alone is
    insufficient to guarantee its integrity.
    	So I would like not to focus so much on is my arm different than
    yours?  Is my hair different than yours?  And ask the question, can't we
    in institutions that do open heart surgery and cardiac transplantation put a
    catheter in safely for a period of time?
    	MR. STUPAK.  Well, let me ask you this, then.  I have only got a little
    bit of time left.  And you started to do this a little bit, but would you
    explain briefly the Toyota process you are using, and I believe Tenet is
    going to use the same system, right?  And how similar is your perfecting
    patient care system to that what Michigan was using?
    	DR. SHANNON.  I can't answer the latter question, but I am confident
    given our results are close that it is probably pretty good.  I would like to
    hear more about it.
    	Perfecting patient care is the application of the principles of the
    Toyota production system to healthcare delivery.  It involves setting four
    important steps.  The first is decoding your data so you understand it in
    its most basic human element, not 5 infections per 1,000 line days, but
    who are the people that get them.
    	The second is observing the current conditions so you understand the
    variation in existing processes, and then you get the workers, not the
    infection control committee, to agree what they think is the best way to
    do it.  You provide guidance through established evidence, but they
    decide on the worker's process and then everyone agrees to it.
    	The third and critical step is each infection must be investigated in
    real time.  That is the context in which you can learn how it happened.
    And if you don't know how it happened, you can't prevent it from
    happening the second time.  And the fourth, then, is to continually look
    at the countermeasures and adjust them as you develop new processes.
    	MR. STUPAK.  Thank you.
    	MR. WHITFIELD.  Thank you, Mr. Stupak.  One other question, Dr.
    Shannon.  In your testimony, you referred to this conspiracy of error and
    waste, and do you think that most hospital administrators really do not
    understand the financial impact of infections?
    	DR. SHANNON.  I believe they do not understand the financial impact
    of these infections.  One of the important exercises that I hope this
    discussion will engender is an opportunity for hospitals across the
    country to go home and look at the cases of their hospital-acquired
    infections and show to their chief financial officers that in fact they are
    losing money on these cases, thereby aligning the incentives all across
    the board for getting serious about fixing them.
    	MR. WHITFIELD.  Well, thank you all very much.  We genuinely
    appreciate your testimony.  It is quite helpful for us, and we loved your
    enthusiasm.  I hope all the participants out there who did not serve on a
    panel enjoyed their day with us as much as we did with them.
    	And so with that, the hearing is adjourned.  The record will be kept
    open for the appropriate number of days for additional filing.
    	[Whereupon, at 5:45 p.m., the subcommittee was adjourned.]

    RESPONSE FOR THE RECORD BY MARC VOLAVKA, EXECUTIVE DIRECTOR, PENNSYLVANIA
    HEALTH CARE COST CONTAINMENT COUNCIL

    RESPONSE FOR THE RECORD BY DR. DENISE CARDO, CHIEF, DIVISION OF HEALTHCARE
    QUALITY PROMOTION, CENTERS FOR DISEASE CONTROL AND PREVENTION, U.S.
    DEPARTMENT OF HEALTH AND HUMAN SERVICES

    Centers for Disease Control and Prevention
    Congressional Responses for the Record
    Questions from Rep. Blackburn and Rep. Dingell
    June 1, 2006

    Rep. Blackburn

    1. In your testimony, you mentioned that CDC developed and disseminated
    evidence-based guidelines to prevent surgical site infections and follow-up
    studies indicated that surgeons were in large part not adhering to those
    recommendations.
    ?	In this example, where is the breakdown?  Have you determined the
    reasons why surgeons were not following the recommendations?
    ?	Did they receive the information?
    ?	Would mandatory reporting help this situation?

            CDC developed and disseminated evidence-based guidelines to prevent
    surgical site infections in April of 1999. Examples of the recommendations
    in this guideline include antimicrobial prophylaxis (first dose,
    antimicrobial agent and duration), preoperative glucose control, and skin
    care.
            These recommendations were made available on CDC's website.  They
    were also published in the American Journal of Infection Control, the
    Journal of Infection Control in Hospital Epidemiology as well as the
    Journal of Surgical Outcomes.    CDC has partnered with the Centers for
    Medicare and Medicaid Services (CMS) in the Surgical Infection Prevention
    Project (SIPP)- a study to assess and promote the adoption of these
    practices among US surgeons.  Results of SIPP revealed that, among 34,133
    surgical procedures (cardiac, vascular, hip/knee, colon, hysterectomy)
    performed in Medicare patients, adherence to recommendations for the
    antimicrobial agents was high (92%), whereas adherence to recommendations
    for timing (48%) and duration (41%) of prophylaxis were suboptimal.
            In addition, CDC conducted an assessment of the adoption of this
    guideline at three hospitals of varying types to identify barriers to
    following recommendations and to discover strategies to improve adherence.
    The evaluation focused on clinicians' adherence to recommended practices for
    surgical prophylaxis and perioperative glucose control among patients
    undergoing major surgical procedures (i.e., coronary artery bypass grafting,
    prosthetic joints, vascular surgery, and general surgery).  Adherence to
    guideline recommendations varied by procedure and facility but overall was
    similar to the SIPP results.  Factors identified from qualitative
    investigation that can foster improved adherence to guidelines included
    orientation and refresher training for staff, multifaceted dissemination of
    recommendations, feedback of infection control data to providers, integration
    of prevention practices into job functions, nurse/physician champions,
    surgical team stability, and outreach to surgeons practicing at multiple
    locations.
            Public reporting of healthcare-associated infections can be a tool
    for increased adherence to recommendations.  CDC's Healthcare Infection
    Control Practices Advisory Committee (HICPAC) has recommended surgical site
    infection rates and antimicrobial prophylaxis prescribing practices as
    measures to be included in mandatory reporting systems for
    healthcare-associated infections.

    2. In your testimony you stated that we need standard definitions and data
    collections tools to improve our practices with hospital acquired infections.
    o	It seems that one of the main issues is trying to agree what the
    definitions should be and how they should be reported.  In your opinion can
    the CDC, working with hospitals and patients, develop these definitions
    without new legislation?
    o	How can this get done?

            Definitional work with a broad spectrum of partners is a major
    component of CDC's national leadership in prevention and control of
    healthcare-associated infections (HAIs).  Past efforts coordinated by CDC
    have yielded widely used, standard definitions for specific types of
    infections.  This work has been accomplished through CDC's programmatic
    initiative and its strong working relationships with multiple stakeholders.
    It has not required specific legislative authority.  Further work is needed
    to update and add to the CDC definitions.  To that end, CDC is actively
    participating in the recently launched National Quality Forum (NQF) project
    on consensus standards for the reporting of HAIs. Preliminary discussions
    in the NQF project suggest that in many instances CDC's definitions will be
    adopted without modification for use by NQF.  The NQF project also provides
    an excellent opportunity to update and add to CDC's definitions as needed
    through a broad based, consensus process.

    3.  In your testimony you mentioned that recently CDC staff were sent to
    North Carolina to study an increase in a certain type of bacteria.  As I
    understand, North Carolina is not one of the states that require mandatory
    reporting.  In this example;
    ?	How did you determine this bacteria, Clostridium difficile, was
    increasing?  What reporting mechanism was used?
    ?	In this case, would mandatory public reporting for this bacteria
    have helped either the patients or you?  Expound on this.

            The investigation of Clostridium difficile infections in North
    Carolina is a good example of the importance of outbreak investigations to
    better understand the characteristics of the illness, the source of
    infection, and prevention strategies. Although Clostridium difficile is the
    most common identified cause of diarrhea among patients in healthcare
    facilities, the investigation in North Carolina is focused on a change in
    the way this organism is infecting people outside of healthcare facilities.
    These persons were presenting to North Carolina hospitals after they become
    infected and it was a physician at a major teaching institution there who
    first noticed the increased number of patients with this infection. The
    healthcare facility contacted the State Health Department and they called
    CDC for assistance. Because these infections were likely acquired outside
    the hospital, it is unlikely that public reporting of healthcare
    facility-associated infection rates alone would have detected this change.
     	This episode highlights the important role that outbreak
    investigations conducted by CDC and local partners can play in the discovery
    and characterization of emerging infectious diseases and other health threats.
    These cases of Clostridium difficile were reported to CDC and were
    investigated as an outbreak of an unusual infection (community associated
    Clostridium difficile).  This and other outbreak investigations of
    Clostridium difficile led to the discovery of the new strain in this country.

    Rep.  Dingell

    1. You testified that hospitals that report the number of certain
    hospital-acquired infections (HAI) as part of the National Nosocomial
    Infections Surveillance System (NNIS) also took steps to reduce their level
    of infection, but they represent only 10 percent of the Nation's hospitals.
    As The New England Journal of Medicine (348:7, 2003) stated in an editorial,
    "If collecting data in isolated hospital areas represents "best practices"
    when 2 million Americans develop a hospital-acquired infection resulting in
    90,000 deaths, and $5 billion in costs, then best is just not good enough."
    What is the Centers for Disease Control and Prevention doing to expand this
    network (National Nosocomial Infections Surveillance System) and to institute
    changes at non-participating hospitals to reduce infection rates and deaths?

            In January 2005, CDC introduced the successor system to its
    National Nosocomial Infections Surveillance (NNIS) system.  The new system,
    the National Healthcare Safety Network (NHSN), enables participation by all
    healthcare facilities that want to voluntarily join with CDC in national
    surveillance of healthcare-associated infections (HAIs).  The information
    technology infrastructure used to build NHSN is more scalable and extensible
    than the infrastructure used to support the NNIS system.  As a result, more
    healthcare facilities can participate, and CDC can more easily add data
    collection and analysis features that focus on facility-level process of care
    improvements.  In addition, non-participating facilities can take advantage
    of the national comparative data produced by NHSN to gauge their progress in
    reducing infection rates and associated costs and mortality.

    2. Will the National Healthcare Safety Network be easier and cheaper for
    participating hospitals?  Are more hospitals expected to participate?

            Yes, the National Healthcare Safety Network (NHSN) will be cheaper
    and easier for hospitals to use.  CDC has streamlined manual data collection
    by reducing the number of data fields that had been required for the National
    Nosocomial Infections Surveillance (NNIS) system.   No additional hardware
    or software purchases will be necessary for hospitals that participated in
    the NNIS system, and new hospitals will not incur substantial information
    technology costs to join the successor system.  As a result, many more
    hospitals are expected to participate in NHSN.  NHSN is being considered as
    a primary tool by several states with public reporting legislation and CDC
    is working with those States to facilitate the use of NHSN for public
    reporting and local prevention of healthcare associated infections.

    3. CDC has its own definitions for HAIs, which many agree are quite
    adequate.  But under the recent Deficit Reduction Act, the Secretary of
    Health and Human Services is mandated to develop definitions and
    methodologies for collecting information on HAIs, and the Nation Quality
    Forum is just beginning a project to establish uniform definitions.  How is
    this (CDC, HHS, NQF) all going to work together?  Are there going to be
    three sets of definitions?

            CDC is working closely with other HHS agencies, including the
    Center for Medicare and Medicaid Services (CMS), and with the National
    Quality Forum (NQF) to assure that a single set of healthcare-associated
    infections (HAIs) definitions will be used in mandatory and voluntary data
    collection activities.  This work requires close collaboration across public
    and private sector organizations.  CDC has considerable experience and
    success in working with other organizations to establish and maintain
    definitional standards.

    4.  What role is CDC playing in the "Save 100,000 Lives" initiative?  Is
    CDC or any other branch of the Federal Government putting any money into
    this effort, or is it completely privately funded?

            Three of the six initiatives of the "Save 100,000 Lives" campaign
    are based on CDC's evidence-based guidelines to prevent bloodstream
    infections, surgical-site infections, and pneumonia. CDC joined the Save
    100,000 Lives campaign in April 2005.  CDC serves as a scientific partner to
    the Institute for Healthcare Improvement (IHI) and provides its expertise in
    preventing healthcare-associated infections to the local and regional
    hospital teams taking part in this campaign to save 100,000 lives. CDC has
    also partnered with IHI in the development of recommendations and tools to
    promote hand hygiene.   The initiative also has been endorsed by two other
    agencies of the Department of Health and Human Services - the Centers for
    Medicare & Medicaid Services and the Agency for Healthcare Research and
    Quality.

    5. Please describe CDC's efforts to collect infection rates from other
    healthcare institutions, such as long-term care facilities, and from
    outpatient procedures performed in both hospitals and specialty medical
    centers.

            CDC's National Healthcare Safety Network (NHSN) is designed for use
    by any healthcare facility that chooses to participate.  The initial version
    of NHSN focuses on healthcare-associated infections reported from acute care
    facilities, including those that perform outpatient operations.  CDC is
    actively enrolling outpatient hemodialysis centers in NHSN at this time.
      	Although the technical infrastructure of the NHSN application can
    be used by any type of healthcare facility, surveillance protocols and
    healthcare-associated infection definitions for settings other than acute
    care and hemodialysis are currently lacking.  CDC is working with partners
    to develop these definitions and protocols.  They will need to be developed
    and tested in other types of healthcare settings, such as long-term care
    facilities, before the full potential of NHSN can be realized.
            Currently, facilities such as long-term care facilities can use
    the system to collect other important pieces of information such as
    antibiotic usage or needlestick injury rates while these other components
    are being developed and tested.

    6.  You testified that both the Keystone and Pittsburgh projects are using
    CDC's recommended practices to reduce HAIs.  But both of those projects
    have copyrighted their processes.  Are they just copyrighting CDC's
    guidelines?  How does CDC distribute its guidelines?   Please include the
    guidelines in your response to this question.

            The copyrighted materials to which you refer (for example, PRHI's
    Perfecting Patient CareT system), are designed to facilitate the successful
    and complete implementation of evidenced-based preventive practices, such as
    CDC recommendations. Neither PRHI nor Keystone, for example, created the
    evidence based practices they used for preventing catheter-associated
    bloodstream infections or ventilator-associated pneumonia; those practices
    come directly from CDC guidelines (which are in the public domain). Rather,
    such organizations are helping to create innovative approaches to changing
    the culture and organization of healthcare delivery in order to help
    hospitals overcome local barriers to successful implementation of
    evidence-based practice, such as the guidance CDC provides. There exists a
    valuable and synergistic relationship between CDC, who provides specific
    evidence-based practice recommendations for preventing
    healthcare-associated infections, and organizations such as PRHI,  Keystone,
    IHI, and others who provide innovative ways to ensure that
    CDC-recommendations are followed.
            CDC distributes its guidance via the Mortality Morbidity Weekly
    Report, through publication in peer reviewed journals, and through the CDC
    website. The guidance documents can be viewed on line at http://www.cdc.gov/ncidod/dhqp/index.html. Hard copies are also attached
    for your perusal.

    7.  At the hearing, you agreed to provide information on the efforts on
    the CMS to reduce HAIs at hospitals serving Medicare patients.  Please
    provide that information for the record.

            The following response was provided by CMS. CMS states:

            "As is indicated in the email received from CDC, it was asserted
    during the E&C oversight hearing that CMS has the authority to withhold
    Medicare and Medicaid payment from hospitals with high rates of
    healthcare-associated infection.  Section 1864(c) in the Social Security
    Act was referenced as giving us this authority.  Section 1864(c) grants
    authority to use state agencies to determine compliance by providers with
    Medicare's conditions of participation.

            In response to the questions raised below, Medicare establishes
    conditions of participation (CoPs) that hospitals must meet to participate
    in the program.  To determine compliance with these Medicare CoPs, CMS
    contracts with state agencies that survey providers to identify situations
    in which the hospital is out of compliance with the standards established
    by Medicare (in so doing, the survey agency identifies "deficiencies").  In
    the case of hospitals, the Social Security Act permits such surveys to
    be conducted by the Joint Commission on Accreditation of Healthcare
    Organizations (JCAHO), if the hospital so chooses.  In the case of
    complaints about particular CoPs, the state survey agencies and CMS can
    also conduct surveys to determine whether the hospital is in compliance
    with CoPs related to the complaint.
     	One such hospital CoP relates to infection control.  The focus of
    the CoP is on monitoring, preventing, and controlling infections and
    communicable diseases.  The hospital Infection Control CoP can be found in
    the Medicare regulations at 42 CFR 482.42.  Hospitals have had to meet the
    infection control requirements since 1986.  To be in compliance with this
    requirement the hospital must:
    	(1) have an active hospital-wide program for the prevention, control,
    and investigation of infections and communicable diseases;
    	(2) provide a sanitary environment to avoid sources and
    transmission of infections and communicable diseases;
    	(3) designate an infection control officer(s), who must develop and
    implement system for preventing, identifying, controlling, investigating,
    and reporting infections as well as maintain a log of incidents related to
    infections and communicable diseases; and
    	(4) hospital leadership must ensure that the hospital-wide quality
    assurance program and training programs address problems identified by the
    infection control officer(s) and they are responsible for the implementation
    of successful corrective action plans in affected problem areas.
            The CoP does not require hospitals to post their infection rates;
    it also does not establish thresholds regarding high or low infection rates.
    However, high infection rates are a clue to surveyors that a hospital's
    program is not preventing infections.  Surveyors evaluate both outcomes
    (such as high infection rates) and processes (such as required practices
    and systems in place to prevent infections) when evaluating compliance with
    the CoP.  Additionally, if a surveyor finds a hospital with high infection
    rates, he/she would also target in on their Quality Assessment and
    Performance Improvement (QAPI) program (which is another CoP) to see if
    they have addressed the infection problem in accordance with the QAPI CoP.
            If the hospital is found to be out of compliance with the CoP (i.e.,
    the hospital is cited for having a serious deficiency related to the CoP),
    then the hospital is put on a track to be terminated from the Medicare
    program.  A hospital in this situation has to respond to the deficiencies
    with a plan of correction.  In its plan of correction, the hospital must
    develop and implement a system-wide plan that corrects the problem and
    improves their performance by implementing measures to correct the
    identified problem, monitor their corrective action(s), and sustain the
    improvements.  If the plan of correction is accepted by the state agency
    then the termination is stopped.  Under this process, the primary
    enforcement mechanism is termination from the program; we do not assess
    civil money penalties."

    8.  Can HAIs be reduced by the single step of requiring hospitals to report
    on the steps they are taking to reduce infections, or does the infection
    rate itself need to be tracked?

            CDC recommends that States considering mandatory public reporting
    of healthcare-associated infections collect both the steps for reducing
    infections (also called process measures) and the risk adjusted rates of
    infections.  This combined information can provide a roadmap for reducing
    infections if it is used to inform local action.

    9.  What is CDC's budget for healthcare quality promotion in FY 2006?
    What has been proposed for FY 2007?

            The FY 06 budget for the Division of Healthcare Quality Promotion,
    CDC  to detect, monitor and prevent healthcare-associated infections was
    $14,759,590. Level funding is expected for FY 07.

    RESPONSE FOR THE RECORD BY DR. ROBERT WARE HALEY, MD, DIVISION OF
    EPIDEMIOLOGY, SOUTHWESTERN MEDICAL SCHOOL, UNIVERSITY OF TEXAS
    SOUTHWESTERN MEDICAL CENTER

    THE UNIVERSITY OF TEXAS
    SOUTHWESTERN MEDICAL CENTER
    AT DALLAS

    Robert W. Haley, M.D.	                                               Department of Internal Medicine
    Professor of Internal Medicine	                                       Division of Epidemiology and
    Holder of the U.S. Armed Forces Veterans	                                      Preventive Medicine
       Distinguished Chair for Medical Research,
       Honoring America's Gulf War Veterans

    Reply To: 	Ed Whitfield
    Chairman
    Subcommittee on Oversight and Investigations
    2125 Rayburn House Office Building,
    Email to Michael Abraham (Michael.Abraham@mail.house.gov)

    From:		Robert W. Haley, M.D.
    			Professor and Director
    			Division of Epidemiology
    			Department of Internal Medicine
    			University of Texas Southwestern Medical Center
    			Dallas, Texas

    Date:		June 22, 2006

    Subject:	Your questions (in bold) and my replies (following)

    1. In your testimony, you mentioned that the NNIS risk index is used all
    over the world. Relating this to reporting of hospital infections;
    	 	How do European or other developed economies track and
    handle these issues?
    	 	How do we compare?

            Yes, the NNIS risk index is used in many countries throughout the
    world.  Here is the evidence.
    ?	Scientific papers reporting validation and use of the NNIS risk
    index have been published by scientists from the U.S., Germany, Spain,
    Belgium, France, Brazil, Vietnam and Pakistan.  I have attached 24
    references to these papers.
    ?	An infection control expert in Spain provided the following
    information:  "SSI surveillance is routinely carried out in most tertiary
    and secondary hospitals in Spain. The situation is something different in
    primary (small local) hospitals. The NNIS has become the predominant index
    and it is used to adjust for differences between services and hospitals,
    even for changes in patients' intrinsic risk of infection across time. The
    Spanish Society of Hospital Preventive Medicine has sponsored a software
    which allows to estimate indirect standardized rates using as reference
    the American NNIS strata rates.  To my knowledge in Germany and Denmark
    there are similar systems to the Spanish and currently are giving indirect
    standardized SSI rates. In the United Kingdom surveillance is performed
    mainly by microbiologists and the use of the NNIS or the SENIC indices is
    not very common. In Italy and France the situation is something between
    Spain and the UK: some centers do routine SSI surveillance and others don't."

            It is difficult to say how the U.S. compares with other countries
    in the implementation of SSI surveillance using the NNIS risk index because
    no recent surveys have documented these practices here.  I would make the
    following comments on this question.
            My impression is that a sizeable minority of U.S. hospitals measure
    rates of SSI and compare their rates to the national standard rates within
    NNIS risk index categories.  Although I have seen no measurements of the
    prevalence of this practice, I suspect it is more than 20% of hospitals and
    probably less than 50%.  From the comments above, the prevalence of this
    practice in U.S. hospitals is probably less than in Spain, Germany and
    Denmark but probably more than in the U.K. and perhaps comparable to Italy
    and France.  Clearly, our practices in U.S. hospitals are not up to what
    they should be if we are serious about employing cost-effective practices
    proven to reduce SSI rates to a practical minimum.  This approach is not
    expensive and yet has been shown to have a powerful effect in reducing SSI
    rates.  The problem is that SSI outcome measurement has never been a high
    priority for many hospitals and in recent years has gotten lost in a sea
    of well intentioned but unproven quality improvement ideas.  Our best
    opportunity right now is to get all hospitals measuring HAI rates while
    coupling this with implementing the "bundle" concept or process control
    popularized by (Institute for Healthcare Improvement) IHI.  These appear to
    be synergistic measures.
            As a note of caution, I would add that we have as yet no experience
    in using the NNIS risk index in public reporting of HAI rates to consumers.
    Undoubtedly, we will need to experiment with a variety of statistical
    approaches to learn the best way to use the NNIS index so that we can
    provide consumers with scientifically valid comparisons of hospitals which
    at the same time are understandable.  This may require new statistical
    methods for using the index and constructing summary rate scores.  Such
    research is starting to pop up in states that are grappling day to day with
    the new mandated reporting systems.  These types of innovations are unlikely
    to come out of expert panels of the NQF or other national standard-setting
    committees.

    2. In your testimony you mentioned that you are in full support of public
    reporting but are not in support of a national mold preceding the states
    activities. You also mention that you expect that the movement within the
    states and with the consumer's union will eventually lead to meaningful
    reduction in hospital infections.
             When Americans read the articles about 90,000 hospital infection
    deaths, they probably won't like to hear that the deaths will eventually be
    less. In your mind, how long is eventually?

            Yes, I am in favor of public reporting of HAI rates but I am not
    in favor of a single national mold for public reporting, such as that being
    explored by the National Quality Forum.  Here is my reasoning.
            ? National standards are useful for issues where strategies are
    well worked out and broadly tested.  Then national standards bring the few
    laggard states and communities up to the proven mark.  With public reporting
    of HAI rates, there is little experience yet with which to judge which
    organizational and logistic approaches are going to be useful and which
    useless or destructive.  It is one thing to say that outcome measurement of
    HAI rates for the public is a good think and to identify the exact way of
    doing it on a statewide basis.  Therefore, I think it is premature to
    establish a national standard for organization and implementation because
    the substance of the standard will be based on speculation rather than on
    broad experience.
            ? Establishing a national standard here at the very start of the
    public reporting movement will curtail valuable experimentation by the
    states-it will dumb down the practice to a common mediocre level.  We have
    seen in countless programs in the past from highway safety to Medicaid
    models that, when allowed to try creative solutions, states come up with
    all kinds of good ideas that eventually catch hold and become de facto
    standards.  The legislatures of several states have empanelled expert
    committees to design their own solutions, and creative ideas have already
    emerged. If a national standard is postponed, we could have potentially 50
    competing experiments from which to choose the most successful.  If we
    encourage or force all states to conform to a single model at this early
    moment, we would lose the benefit of the states' creative ideas and
    experiments and thus do a disservice to patients over the long haul.
            ? I am extremely concerned that a national forum, such as that to
    be convened by the NQF, will be usurped by special interests represented
    on their panels that will steer the national standard toward proprietary or
    ideological solutions that will ultimately prove ineffective.  Such panels
    are also likely to be swayed by enthusiastic reports of anecdotal successes
    not representing truly proven and tested approaches.  Hopefully the expert
    panels in various states will steadfastly pursue their own creative ideas
    so that in the end the effective strategies will rise to the top.
            ? Fundamentally public reporting of HAI rates has risen as a state
    issue being effectively addressed by state legislatures and expert panels
    within those states.  I see no basis for the federal government to become
    involved in standard setting at this time.  The federal funding programs
    will be better served to watch the states reporting programs emerge and
    weigh in when effective approaches are identified and studied.

            I believe that the public reporting movement will eventually lead
    to large reductions in HAI rates in all U.S. hospitals.  Outcome measurement
    with feedback of outcome rates has been demonstrated widely in industry to
    improve manufacturing quality (reference the quality control principles of
    W. Edwards Deming based fundamentally on outcome measurement).  The only
    scientific evidence from controlled studies on reducing HAI rates
    demonstrated that outcome measurement with feedback to surgeons and other
    hospital personnel drives the reduction of HAI rates.  This has been known
    for over 100 years, is proven, and has been successfully implemented in a
    sizeable minority of U.S. hospitals.  Therefore, I am confident that
    implementing outcome measurement in all U.S. hospitals will have a large
    impact and reduce HAI rates far below their present level.
            Very simply, I believe that the numbers of deaths, as well as the
    suffering, disability and costs, from HAIs will immediately start falling
    as more and more hospitals implement outcome measurement with risk
    stratification and feedback of rates to surgeons and other hospital
    personnel.  State laws requiring outcome measurement for the different
    purpose of informing the public will greatly hasten its wide implementation,
    and if the rates reported to the public are also effectively fed back to
    surgeons and other hospital personnel, rates will fall.  With the rapid
    progress in adoption by state legislatures that we are seeing at present, I
    suspect that outcome measurement could be happening in perhaps half the
    states within 2 years.  As successes from these become publicized, I
    suspect the remaining states will be on board in 4-5 years time.
            To the impatient, I would urge restraint.  The biggest threat to
    implementation of approaches that have been proven to work is a hasty dash
    to require all hospitals to conform.  This is likely to lead to some
    national standard-setting body's decreeing the wrong organizational and
    logistical approaches and ending up with no reductions in the deaths,
    morbidity, disability and costs at all.  We saw a vivid illustration of
    this problem in Pennsylvania in its first years of public reporting.
            Right now, we see a healthy grass roots movement, fueled by the
    Consumer Union, taking root in state after state.  If the states are left
    to experiment and evolve the best programs, in several years we will know
    what works and then we can develop national standards to bring the laggard
    states and hospitals up to par.  But premature standard-setting at this
    critical moment is likely to clutch defeat from the jaws of victory.

    References on use of the NNIS Risk Index in various countries

    1. Haley RW, Culver DH, Morgan WM, White JW, Emori TG, Hooton TM.
    Identifying patients at high risk of surgical wound infection. A simple
    multivariate index of patient susceptibility and wound contamination. Am J
    Epidemiol 1985; 121:206-215. [US]
    2. Culver DH, Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG et al.
    Surgical wound infection rates by wound class, operative procedure, and
    patient risk index. National Nosocomial Infections Surveillance System.
    Am J Med 1991; 91:152S-157S. [US]
    3. Gross PA. Striving for benchmark infection rates: progress in control
    for patient mix. Am J Med 1991; 91:16S-20S. [US]
    4. Haley RW. The scientific basis for using surveillance and risk factor
    data to reduce nosocomial infection rates. J Hosp Infect 1995; 30
    suppl:3-14. [US]
    5. Barrasa Villar JI, Domingo C, I, Vizmanos SF. Use of the NNIS index for
    determining the intrinsic risk of surgical infection. Medicina Clinica
    1996; 107:767-771. [Spain]
    6. Ronveaux O, Mertens R, Dupont Y. Surgical wound infection surveillance:
    results from the Belgian hospital network. Acta Chirurgica Belgica 1996;
    96:3-10. [Belgium]
    7. Salemi C, Anderson D, Flores D. American Society of Anesthesiology scoring
    discrepancies affecting the National Nosocomial Infection Surveillance System:
    surgical-site-infection risk index rates. Infect Control Hosp Epidemiol 1997;
    18:246-247. [US]
    8. Delgado-Rodriguez M, Medina-Cuadros M, Martinez-Gallego G, Sillero-Arenas
    M. Usefulness of intrinsic surgical wound infection risk indices as predictors
    of postoperative pneumonia risk. J Hosp Infect 1997; 35:269-276. [Spain]
    9. Delgado-Rodriguez M, Sillero-Arenas M, Medina-Cuadros M, Martinez-Gallego
    G. Nosocomial infections in surgical patients: comparison of two measures of
    intrinsic patient risk. Infect Control Hosp Epidemiol 1997; 18:19-23. [Spain]
    10. Korinek AM. Risk factors for neurosurgical site infections after
    craniotomy: a prospective multicenter study of 2944 patients. The French
    Study Group of Neurosurgical Infections, the SEHP, and the C-CLIN Paris-Nord.
    Service Epidemiologie Hygiene et Prevention. Neurosurgery 1997; 41:1073-1079.
    [France]
    11. Delgado-Rodriguez M, Sillero-Arenas M, Medina-Cuadros M, Martinez-Gallego
    G. Usefulness of intrinsic infection risk indexes as predictors of
    in-hospital death. American Journal of Infection Control 1997; 25:365-370.
    [Spain]
    12. Delgado-Rodriguez M, Medina CM, Martinez GG, Sillero AM. [The usefulness
    of intrinsic risk factors of infection of the surgical site as predictors of
    other infections and death]. [Spanish]. Enfermedades Infecciosas y
    Microbiologia Clinica 1998; 16:2-8. [Spain]
    13. Delgado-Rodriguez M, Gomez-Ortega A, Llorca J, Lecuona M, Dierssen T,
    Sillero-Arenas M et al. Nosocomial infection, indices of intrinsic infection
    risk, and in-hospital mortality in general surgery. J Hosp Infect 1999;
    41:203-211. [Spain]
    14. Valls V, Diez M, Ena J, Gutierrez A, Gomez-Herruz P, Martin A et al.
    Evaluation of the SENIC risk index in a Spanish university hospital. Infect
    Control Hosp Epidemiol 1999; 20:196-199. [Spain]
    15. Freitas PF, Campos ML, Cipriano ZM. Suitability of the Hospital Infection
    National Surveillance System (NNISS) risk index for the prediction of the
    incidence of surgical site infection at a university hospital in
    Florianopolis, South Brazil. Revista Da Associacao Medica Brasileira 2000;
    46:359-362. [Brazil]
    16. Roy MC, Herwaldt LA, Embrey R, Kuhns K, Wenzel RP, Perl TM. Does the
    Centers for Disease Control's NNIS system risk index stratify patients
    undergoing cardiothoracic operations by their risk of surgical-site
    infection? Infect Control Hosp Epidemiol 2000; 21:186-190. [US]
    17. Delgado-Rodriguez M, Gomez-Ortega A, Sillero-Arenas M, Martinez-Gallego
    G, Medina-Cuadros M, Llorca J. Efficacy of surveillance in nosocomial
    infection control in a surgical service. American Journal of Infection
    Control 2001; 29:289-294. [Spain]
    18. Gaynes RP, Culver DH, Horan TC, Edwards JR, Richards C, Tolson JS.
    Surgical site infection (SSI) rates in the United States, 1992-1998: the
    National Nosocomial Infections Surveillance System basic SSI risk index.
    Clin Infect Dis 2001; 33:Suppl-77. [US]
    19. 	Astagneau P, Rioux C, Golliot F, Brucker G, INCISO Network Study Group.
    Morbidity and mortality associated with surgical site infections: results from the
    1997-1999 INCISO surveillance. J Hosp Infect 2001; 48:267-274. [France]
    20. Nguyen D, MacLeod WB, Phung DC, Cong QT, Nguy VH, Van NH et al.
    Incidence and predictors of surgical-site infections in Vietnam. Infect
    Control Hosp Epidemiol 2001; 22:485-492. [Vietnam]
    21. Reid R, Simcock JW, Chisholm L, Dobbs B, Frizelle FA. Postdischarge
    clean wound infections: incidence underestimated and risk factors
    overemphasized. ANZ J Surg 2002; 72:339-343. [US]
    22. Pishori T, Siddiqui AR, Ahmed M. Surgical wound infection surveillance
    in general surgery procedures at a teaching hospital in Pakistan. American
    Journal of Infection Control 2003; 31:296-301. [Pakistan]
    23. Hirsemann S, Sohr D, Gastmeier K, Gastmeier P. Risk factors for
    surgical site infections in a free-standing outpatient setting. American
    Journal of Infection Control 2005; 33:6-10. [Germany]
    24. Thu LT, Dibley MJ, Ewald B, Tien NP, Lam LD. Incidence of surgical
    site infections and accompanying risk factors in Vietnamese orthopaedic
    patients. J Hosp Infect 2005; 60:360-367. [Vietnam]

    RESPONSE FOR THE RECORD BY RAYMOND T. WAGNER, JR., LEGAL AND LEGISLATIVE VICE
    PRESIDENT, ENTERPRISE RENT-A-CAR

    June 1, 2006

    Congressman Ed Whitfield
    Chairman, Subcommittee on Oversight and Investigations
    Committee of Energy and Commerce
    Rayburn House Office Building, Room 2125
    Washington, DC 20515

    Re:  Questions submitted during open period following March 29, 2006 hearing on
    Hospital Acquired Infections.

    Dear Chairman Whitfield:

            I write in response to the questions forwarded to me by the
    Subcommittee on Oversight and Investigations, following the hearing entitled
    "Public Reporting of Hospital-Acquired Infections: Empowering Patients,
    Saving Lives" held on March 29, 2006.  Two questions were presented by
    Honorable Marsha Blackburn.  I will repeat each question and then provide
    my comment below.

            Question 1)  This past Sunday, the Lexington Herald Leader ran a
    story on hospital acquired infections. In this article, an epidemiologist is
    quoted as saying, "The more honest you are, the more you put yourself in a
    bad light." He was referring to some hospitals being aggressive in reporting
    while others less so.  Through your experience with your son as well as your
    experience as a Legislative Vice President, I know you understand the inner
    workings of hospital infections as well as the regulatory process.
     What is your reaction to that comment?
     Is it valid?

            At first blush, this statement ("The more honest you are, the more
    you put yourself in a bad light.") could have some credence, however,
    looking at the converse of that statement ("The more dishonest you are, the
    more you put yourself in a favorable light."), suggests a different answer.
    I do not believe that hospital professionals will intentionally or
    negligently circumvent the rules. Any potential for differences in data
    collection based upon the aggressiveness of the hospital collecting staff
    will be smoothed out through proper hospital training, as well as proper
    guidance from state health departments, hospital associations, the Centers
    for Disease Control (CDC), and other professional organizations.
    Furthermore, a state's regulatory and oversight process will also provide a
    checks and balance on information gathering and reporting techniques.
            Finally, the notion that there will be different outcomes based
    upon the level of implementation or aggressiveness, strikes me as a typical
    response of any "regulated group" when guidelines or regulations are
    proposed.  Restaurants certainly comply with uniform health and safety
    codes.  Businesses comply with uniform employment laws and tax codes.
    Many industries are subject to inspections by oversight governmental bodies.
    The argument of uneven application of a regulation, if followed by
    governmental entities as a rule, would lead to paralysis in the promulgation
    of health and safety standards throughout the country.  Reporting laws can
    be uniformly implemented, and will be improved in the course of time with
    experience.

            Question 2)  In your testimony, you mentioned, "the hospitals were
    not leading the discussion, as they should." Through you taking the bull
    by the horns, you worked and earned the support of the Missouri Hospital
    Association.
             In your experience, are the hospitals now leading this discussion,
    or are at least willing to make steps forward?
             On our third panel, we have Administrators representing 7 different
    hospitals or hospital chains. What would you like to hear from them regarding
    this issue?

            In response, I believe that hospitals are increasingly willing to
    take steps forward in response to the increased demand from the public
    across the country.  It is my understanding that similar reporting bills
    have been introduced in thirty or more states throughout the country.
    Hospital associations are increasingly taking part in these legislative
    efforts.  That said, there is room for substantial improvement on the part
    of the hospital community.  To date, the states and the Federal government
    have not come far enough to address the problem of hospital-acquired deadly
    infections, largely due to hospital opposition and claims that "this can't
    be done."
            In Missouri, I was very pleased and proud that the Missouri Hospital
    Association took a leadership role in supporting legislation once the bill
    was introduced.  They provided necessary expertise during the course of the
    legislative and the subsequent rule-making process.  This cooperative effort
    between hospitals, medical professionals, consumers, patient groups, and the
    business community has served the Missouri process well.  I believe the other
    states could be well-served with pro-active hospital participation and
    aggressive CDC participation.
            Regarding hospital administrators, I would like to hear that they
    are committed to progressively addressing the problem of hospital-acquired
    infections.  I would like to see them pledge to establish appropriate long
    term goals to minimize or rid hospitals of these deadly infections, e.g.,
    reducing hospital-acquired infection rates by 50% or 75% within five years,
    or 100% compliance with hand-washing guidelines within 12 months.  Hospitals
    should recognize that patients and their families are demanding attention
    to this problem.  Only through proper regulations and implementation of
    best practices can this problem effectively be addressed.
            I would respectfully ask administrators to commit to raise the
    level of awareness of the seriousness of hospital-acquired infections with
    their staff and with patients.  Action under this commitment would include
    proper training of hospital staff and education of patients and visitors
    when visiting hospitals.
            I hope that this is responsive to Congresswoman Blackburn's
    questions.  I would be pleased to offer any additional follow-up to Members
    of the Committee.  Again, I thank you very much for holding this important
    hearing.  I stand ready to continue to assist the important work with your
    Subcommittee in every way possible.

    Very truly yours,

    Raymond T. Wagner, Jr.
    Legal and Legislative Vice-President
    Enterprise Rent-A-Car Company
    St. Louis, Missouri