PUBLIC REPORTING OF 

HOSPITAL-ACQUIRED INFECTION 

RATES: EMPOWERING 

CONSUMERS, SAVING LIVES 

HEARING 

BEFORE THE 

SUBCOMMITTEE ON OVERSIGHT AND 

INVESTIGATIONS 

OF THE 

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED NINTH CONGRESS 

SECOND SESSION 

MARCH 29, 2006 

Serial No. 109-85 

Printed for the use of the Committee on Energy and Commerce 

Available via the World Wide Web: http://www.access.gpo.gov/congress/house 

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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 

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28-512PDF 
COMMITTEE ON ENERGY AND COMMERCE 

JOE BARTON, Texas, Chairman 

RALPH M. HALL, Texas 

MICHAEL BILIRAKIS, Florida 

 Vice Chairman 

FRED UPTON, Michigan 

CLIFF STEARNS, Florida 

PAUL E. GILLMOR, Ohio 

NATHAN DEAL, Georgia 

ED WHITFIELD, Kentucky 

CHARLIE NORWOOD, Georgia 

BARBARA CUBIN, Wyoming 

JOHN SHIMKUS, Illinois 

HEATHER WILSON, New Mexico 

JOHN B. SHADEGG, Arizona 

CHARLES W. “CHIP” PICKERING, Mississippi 

 Vice Chairman

VITO FOSSELLA, New York 

ROY BLUNT, Missouri

STEVE BUYER, Indiana 

GEORGE RADANOVICH, California 

CHARLES F. BASS, New Hampshire 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE FERGUSON, New Jersey 

MIKE ROGERS, Michigan 

C.L. “BUTCH” OTTER, Idaho 

SUE MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

JOHN D. DINGELL, Michigan 

 Ranking Member 

HENRY A. WAXMAN, California 

EDWARD J. MARKEY, Massachusetts 

RICK BOUCHER, Virginia 

EDOLPHUS TOWNS, New York 

FRANK PALLONE, JR., New Jersey 

SHERROD BROWN, Ohio 

BART GORDON, Tennessee 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

BART STUPAK, Michigan 

ELIOT L. ENGEL, New York 

ALBERT R. WYNN, Maryland 

GENE GREEN, Texas 

TED STRICKLAND, Ohio 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MIKE DOYLE, Pennsylvania 

TOM ALLEN, Maine 

JIM DAVIS, Florida 

JAN SCHAKOWSKY, Illinois 

HILDA L. SOLIS, California 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

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 

CHARLES W. “CHIP” PICKERING, Mississippi 

CHARLES F. BASS, New Hampshire 

GREG WALDEN, Oregon 

MIKE FERGUSON, New Jersey 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

JOE BARTON, Texas 

 (EX OFFICIO)

BART STUPAK, Michigan 

 Ranking Member 

DIANA DEGETTE, Colorado 

JAN SCHAKOWSKY, Illinois 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

HENRY A. WAXMAN, California 

JOHN D. DINGELL, Michigan 

 (EX OFFICIO)

(II)
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-aCar, response for the record ........................................................................................... 303 

(III) 

(1) 

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 hospitalacquired 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 
2

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. 
3

 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. 
4

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 
5

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 pseudocholodestrates 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 
6

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 
7

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 
8

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:] 
9

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. 
10

 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 hospitalacquired 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 comorbidities. 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 hospitalacquired 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 
11

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, 
12

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 
13

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 
14

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. 
15

STATEMENT OF RAYMOND T. WAGNER, JR., LEGAL AND 

LEGISLATIVE VICE PRESIDENT, ENTERPRISE RENT-ACAR 

 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 Renta-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 
16

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 hospitalacquired 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 
17

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 hospitalacquired 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 VicePresident. 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 
18

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 
19

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 
20

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.1

 

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 

 

1

 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. 
21

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 hospitalacquired 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. 
22

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. 
23

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 hospitalacquired 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 
24

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, 
25

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. 
26

 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 welldistanced 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 
27

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 
28

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. 
29

 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? 
30

 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. 
31

 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. 
32

 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 
33

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. 
34

 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. 
35

 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-ofnetwork 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? 
36

 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.] 
37

 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 healthcareassociated 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 healthcareassociated 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, 
38

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 healthcareassociated infections. This document includes recommendations to 

States considering legislation for mandatory reporting of healthcareassociated 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:] 
39

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 healthcareassociated 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. 
40

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 healthcareassociated 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 
41

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 healthcareassociated 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 healthcareassociated infections. 
42

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 healthcareassociated 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 healthcareassociated 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 healthcareassociated 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 
43

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 realtime response to infections. These experiences with Pittsburgh Regional Healthcare 

Initiative highlight the importance of regional data for local action to prevent healthcareassociated 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 healthcareassociated 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 
44

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 healthcareassociated 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. 
45

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. 

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 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 healthcareassociated 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. 
212

 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? 
213

 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, 
214

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 
215

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 longterm 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 longterm 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. 
216

 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 
217

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 
218

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 hospitalacquired 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? 
219

 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 inhospital infection. Have we just developed some really strong bugs out 

there, or are there other factors involved here? 
220

 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 overprescription 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? 
221

 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 
222

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 
223

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 
224

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 
225

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 fiveminute 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. 
226

 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 inkind 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 catheterrelated 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 
227

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 
228

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 
229

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 
230

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. 
231

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), 
232

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 
233

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 
234

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 controlintervention 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 
235

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 
236

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 
237

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 
238

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 
239

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. 
240

 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 hospitalacquired 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.” 
241

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. Hospitalacquired 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 
242

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, 
243

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 hospitalacquired 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 
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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 hospitalacquired 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. 
245

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 hospitalacquired 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 hospitalacquired 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. 
246

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 
247

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 openheart 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: 
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“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 hospitalacquired 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 hospitalacquired 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. 
249

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. 
250

 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 
251

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 
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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. 
253

 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. 
254

The Theory of Inevitability 

A major challenge to the integrity of public reporting is the notion that hospitalacquired 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 CareTM 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. 
255

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. 
256

 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 CareTM, 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 
257

Traditional 

Approach

FY 03

PPC Approach

FY 04

Year 1

PPC Approach

FY 05

Year 2

PPC Approach

FY 06 (8 months)

Year 3

ICU Admissions 

(n)

1753 1798 1829 1394

Atlas Severity 

Grade

1.9 2.0 2.1 2.2

Age (years) 62 (24-80) 62 (50-74) 65 (39-71) 64 (56-76)

Gender (M/F) 22/15 3/3 4/7 1 / 2

Central lines 

employed (n)

1110 1321* 1487* 1605*

Line-days 4687 5052* 6705* 6667*

Infections 49 6* 11* 3*

Patients Infected 37 6* 11* 3*

Rates (infections/ 

1000 line-days)

10.5 1.2* 1.6* 0.45*

Deaths 19 1 * 2 * 1 *

Reliability (# of 

lines placed to get 

1 infection)

22 185* 135* 535*

Figure 1

Case 1 

• 37 year old video game programmer, father of 4, 

admitted with acute pancreatitis secondary to 

hypertriglyceridemia.

• Day 3: developed hypotension, and respiratory failure

• Day 6 : fever and blood cultures positive for MRSA 

secondary to a femoral vein catheter in place for 4 

days.

• Multiple infectious complications requiring exploratory 

laparotomy and eventually tracheotomy

• Day 86: Discharged to nursing home

Figure 2
258

The Impact of CLABs on Gross Margin

LOS 4 38 41 86

Costs 170,565

attributable 

to CLAB

Gross 119 40,309 27,482 -41,813

Margin

Expense 5,788 58,905 98,094 241,844

Revenue ($) 5,907 99,214 125,576 200,031

Pancreatitis 

w trach

Pancreatitis 

w cc

Acute 

pancreatitis

DRG 483 Case 1

(n=2)

DRG 191

(n=3)

DRG 

204/2721

(n=3)

Figure 3

 

The Losses Attributable to 

CLABs are Staggering

• Average reimbursement: $64,894

• Average Expense: $91,733

• Average Loss from Operations: -$26,839

• Total Loss from Operations:-$1,449,306 

• In only 4 cases did the hospital make money!

• The cost of the additional care averaged 43% 

of the total costs of care

• Average LOS: 28 days (5-86)

• Only three patients were discharged to home.

Figure 4
259

The Losses Attributable to Ventilator 

associated Pneumonia are Equally 

Staggering

• Average reimbursement: $62,883

• Average Expense: $87,318

• Average Loss from Operations: -$24,435

• Total Loss from Operations:-$2,419,065

• The average payments were twice that for similar care 

with VAP ($33,569)

• Average LOS: 34 days versus 17 days 

• 32% of patients died and 43% underwent tracheotomy.

Figure 5

CCU/MICU and HAI

A Big Return on Investment

• Total Savings 

CLAB= $1,235,765 (2 years)

VAP= $1,003,162 (1 year)

• Highmark PFP = $2,100,000

• HAI elimination Initiatives = +$4,338,927

• Investment = $34,927

• 126 additional ICU admissions

• 47 lives saved

Figure 6

MR. WHITFIELD. Thank you, Dr. Shannon. 

 Dr. Hammer, you are recognized for five minutes. 
260

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 
261

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. 
262

 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 NewYorkPresbyterian 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 
263

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 ratecalculation 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.1

 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 

 

1

 Two additional states – Nevada and Nebraska – also have enacted legislation to require the 

collection and calculation of HAI rates, however, the resulting data are reported only to the state 

agencies responsible for public health, and presently are not disclosed to the public. 
264

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 userfriendly 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 Methicillinresistant 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 
265

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 betterequipped 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 
266

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 
267

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. 
268

 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 
269

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 healthcareacquired 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 clearlydefined 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 infectionrelated 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 
270

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 healthcareacquired 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 
271

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 healthcareacquired 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 
272

 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, ventilatorassociated, 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 
273

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 hospitalacquired 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 hospitalacquired 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 
274

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. 
275

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 catheterassociated 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), vancomycinresistant 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. 
276

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 
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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 
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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 
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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 
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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. 
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 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 
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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. 
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 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. 
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 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 
285

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. 
286

 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.] 
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RESPONSE FOR THE RECORD BY MARC VOLAVKA, EXECUTIVE DIRECTOR, PENNSYLVANIA 

HEALTH CARE COST CONTAINMENT COUNCIL
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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. 

 
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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 
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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? 
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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 CareTM 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. 
296

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 
297

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 healthcareassociated 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. 
298

RESPONSE FOR THE RECORD BY DR. ROBERT WARE HALEY, MD, DIVISION OF 

EPIDEMIOLOGY, SOUTHWESTERN MEDICAL SCHOOL, UNIVERSITY OF TEXAS 

SOUTHWESTERN MEDICAL CENTER

THE UNIVERSITY OF TEXAS 

SOUTHWESTERN MEDICAL CENTER 

AT DALLAS 

Robert W. Haley, M.D. Department of Internal Medicine 

Professor of Internal Medicine Division of Epidemiology and 

Holder of the U.S. Armed Forces Veterans Preventive Medicine 

 Distinguished Chair for Medical Research, 

 Honoring America’s Gulf War Veterans 

Reply To: Ed Whitfield 

Chairman 

Subcommittee on Oversight and Investigations 

2125 Rayburn House Office Building, 

Email to Michael Abraham (Michael.Abraham@mail.house.gov) 

From: Robert W. Haley, M.D. 

 Professor and Director 

 Division of Epidemiology 

 Department of Internal Medicine 

 University of Texas Southwestern Medical Center 

 Dallas, Texas 

Date: June 22, 2006 

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

1. In your testimony, you mentioned that the NNIS risk index is used all over the 

world. Relating this to reporting of hospital infections; 

• How do European or other developed economies track and handle these 

issues? 

• How do we compare? 

Yes, the NNIS risk index is used in many countries throughout the world. Here is 

the evidence. 

• Scientific papers reporting validation and use of the NNIS risk index have been 

published by scientists from the U.S., Germany, Spain, Belgium, France, 

Brazil, Vietnam and Pakistan. I have attached 24 references to these papers. 

• An infection control expert in Spain provided the following information: “SSI 

surveillance is routinely carried out in most tertiary and secondary hospitals in 

Spain. The situation is something different in primary (small local) hospitals. 

The NNIS has become the predominant index and it is used to adjust for 

differences between services and hospitals, even for changes in patients’ 

intrinsic risk of infection across time. The Spanish Society of Hospital 

Preventive Medicine has sponsored a software which allows to estimate 

indirect standardized rates using as reference the American NNIS strata rates. 

To my knowledge in Germany and Denmark there are similar systems to the 
299

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 
300

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 
301

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 standardsetting 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 

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13. Delgado-Rodriguez M, Gomez-Ortega A, Llorca J, Lecuona M, Dierssen T, SilleroArenas M et al. Nosocomial infection, indices of intrinsic infection risk, and inhospital 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:Suppl77. [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] 
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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. 
304

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 rulemaking 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 

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