[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


                                  -------
                    U.S. GOVERNMENT PRINTING OFFICE
28-512                      WASHINGTON : 2006
_____________________________________________________________________________
For sale by the Superintendent of Documents, U.S. Government Printing Office
Internet: bookstore.gpo.gov  Phone: toll free (866) 512-1800; DC area (202) 512-1800 Fax: (202) 512-2250  Mail: Stop  SSOP, Washington, DC 20402-0001



                    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 ([email protected])

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

	

