[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]



 
 ANALYZING VA'S ACTIONS TO PREVENT LEGIONNAIRES' DISEASE IN PITTSBURGH 

=======================================================================

                                HEARING

                               before the

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                 of the

                     COMMITTEE ON VETERANS' AFFAIRS
                     U.S. HOUSE OF REPRESENTATIVES

                    ONE HUNDRED THIRTEENTH CONGRESS

                             FIRST SESSION

                               __________

                       TUESDAY, FEBRUARY 5, 2013

                               __________

                            Serial No. 113-1

                               __________

       Printed for the use of the Committee on Veterans' Affairs

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                     COMMITTEE ON VETERANS' AFFAIRS

                     JEFF MILLER, Florida, Chairman

DOUG LAMBORN, Colorado               MICHAEL H. MICHAUD, Maine, Ranking 
GUS M. BILIRAKIS, Florida            Minority Member
DAVID P. ROE, Tennessee              CORRINE BROWN, Florida
BILL FLORES, Texas                   MARK TAKANO, California
JEFF DENHAM, California              JULIA BROWNLEY, California
JON RUNYAN, New Jersey               DINA TITUS, Nevada
DAN BENISHEK, Michigan               ANN KIRKPATRICK, Arizona
TIM HUELSKAMP, Kansas                RAUL RUIZ, California
MARK E. AMODEI, Nevada               GLORIA NEGRETE MCLEOD, California
MIKE COFFMAN, Colorado               ANN M. KUSTER, New Hampshire
BRAD R. WENSTRUP, Ohio               BETO O'ROURKE, Texas
PAUL COOK, California                TIMOTHY J. WALZ, Minnesota
JACKIE WALORSKI, Indiana

            Helen W. Tolar, Staff Director and Chief Counsel

                                 ______

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                    MIKE COFFMAN, Colorado, Chairman

DOUG LAMBORN, Colorado               ANN KIRKPATRICK, Arizona, Ranking 
DAVID P. ROE, Tennessee              Minority Member
TIM HUELSKAMP, Kansas                MARK TAKANO, California
DAN BENISHEK, Michigan               ANN M. KUSTER, New Hampshire
JACKIE WALORSKI, Indiana             BETO O'ROURKE, Texas
                                     TIMOTHY J. WALZ, Minnesota

Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public 
hearing records of the Committee on Veterans' Affairs are also 
published in electronic form. The printed hearing record remains the 
official version. Because electronic submissions are used to prepare 
both printed and electronic versions of the hearing record, the process 
of converting between various electronic formats may introduce 
unintentional errors or omissions. Such occurrences are inherent in the 
current publication process and should diminish as the process is 
further refined.



                            C O N T E N T S

                               __________

                            February 5, 2013

                                                                   Page

Analyzing VA's Actions To Prevent Legionnaires' Disease In 
  Pittsburgh.....................................................     1

                           OPENING STATEMENTS

Hon. Mike Coffman, Chairman, Subcommittee on Oversight and 
  Investigations.................................................     1
    Prepared Statement of Hon. Coffman...........................    61
Hon. Ann Kirkpatrick, Ranking Minority Member, Subcommittee on 
  Oversight And Investigations...................................     3
Hon. Mike Doyle, (D-PA-14).......................................     4

                               WITNESSES

Dr. Robert Jesse, Principal Deputy Under Secretary for Health, 
  U.S. Department of Veterans Affairs............................     6
    Prepared Statement of Dr. Jesse..............................    62
    Accompanied by:

      Mike Moreland, Network Director, VISN 4, U.S. Department of 
          Veterans Affairs
      Dr. Gary Roselle, Chief, Medical Service, Program Director, 
          Infectious Diseases, U.S. Department of Veterans 
          Affairs
Dr. Lauri Hicks, Medical Epidemiologist, National Center for 
  Immunization and Respiratory Diseases, Center for Disease 
  Control and Prevention.........................................     8
    Prepared Statement of Dr. Hicks..............................    65
Dr. Victor L. Yu, Professor of Medicine, University of Pittsburgh    39
    Prepared Statement of Dr. Yu.................................    69
    Executive Summary of Dr. Yu..................................    81
Dr. Janet Stout, Director, Special Pathogens Laboratory..........    41
    Prepared Statement of Dr. Stout..............................    82
    Executive Summary of Dr. Stout...............................    87
Aaron Marshall, Operations Manager, Enrich Products, Inc.........    43
    Prepared Statement of Mr. Marshall...........................    89
Steve Schira, Chairman and Chief Executive Officer, Liquitech, 
  Inc............................................................    45
    Prepared Statement of Mr. Schira.............................    90
Kathleen Dahl, President, AFGE Local 2028, Pittsburgh Veterans 
  Affairs Medical Center.........................................    46
    Prepared Statement of Ms. Dahl...............................    91
    Executive Summary of Ms. Dahl................................    98

                       SUBMISSION FOR THE RECORD

Mr. Edward Dudek, M.P.P.M., Assistant Vice President, Facilities, 
  Engineering, and Maintenance, University of Pittsburgh Medical 
  Center, UPMC Presbyterian Shadyside Hospital and Dr. Carlene 
  Muto, Associate Professor of Medicine, University of Pittsburgh 
  Medical Center.................................................    98

                        QUESTIONS FOR THE RECORD

Letter From: Hon. Michael H. Michaud, Ranking Minority Member, 
  Full Committee, To: Hon: Eric K. Shinseki, Secretary, 
  Department of Veterans Affairs.................................   101
Questions From: Hon. Michael H. Michaud, Ranking Minority Member, 
  Full Committee, and Hon. Ann Kirkpatrick, Ranking Minority 
  Member, Subcommittee on Oversight and Investigations To: 
  Department of Veterans Affairs.................................   101
Responses From: Department of Veterans Affairs, To: Hon. Michael 
  H. Michaud, Ranking Minority Member, Full Committee, and Hon. 
  Ann Kirkpatrick, Ranking Minority Member, Subcommittee on 
  Oversight and Investigations...................................   102
Letter From: Hon. Michael H. Michaud, Ranking Minority Member, 
  Full Committee, To: Dr. Lauri Hicks, D.O., Medical 
  Epidemiologist, Division of Bacterial Diseases, Centers for 
  Disease Control and Prevention, U.S. Department of Health and 
  Human Services.................................................   108
Questions From: Hon. Michael H. Michaud, Ranking Minority Member, 
  Full Committee, To: Centers for Disease Control and Prevention, 
  U.S. Department of Health and Human Services...................   108
Response From: Centers for Disease Control and Prevention, U.S. 
  Department of Health and Human Services, To: Hon. Michael H. 
  Michaud, Ranking Minority Member, Full Committee...............   109


 ANALYZING VA'S ACTIONS TO PREVENT LEGIONNAIRES' DISEASE IN PITTSBURGH

                       Tuesday, February 5, 2013

             U.S. House of Representatives,
                    Committee on Veterans' Affairs,
              Subcommittee on Oversight and Investigations,
                                                   Washington, D.C.
    The Subcommittee met, pursuant to notice, at 9:59 a.m., in 
Room 334, Cannon House Office Building, Hon. Mike Coffman 
[Chairman of the Subcommittee] presiding.
    Present: Representatives Coffman, Roe, Huelskamp, Benishek, 
Walorski, Kirkpatrick, Kuster, and Walz.
    Also Present: Representatives Miller, Rothfus, Murphy, and 
Doyle.

             OPENING STATEMENT OF CHAIRMAN COFFMAN

    Mr. Coffman. Good morning. This hearing will come to order.
    I want to welcome everyone to today's hearing titled 
Analyzing VA's Actions to Prevent Legionnaires' Disease in 
Pittsburgh.
    I would also like to ask unanimous consent that several of 
our Pennsylvania colleagues be allowed to join us here on the 
dais to hear about an issue very specific to their 
constituents. Hearing no objection, so ordered.
    Today's hearing is based on a recent outbreak of 
Legionnaires' Disease in the Pittsburgh VA Medical Center. At 
least 26 recent cases of Legionnaires' Disease have been 
associated with the Pittsburgh VAMC.
    While VA has stated that eight of these cases were 
definitely not contracted at their hospital, it has also stated 
that it cannot determine whether 16 of these cases were 
contracted at the hospital.
    VA contacted the CDC last fall to investigate the issue. 
The CDC's report just released on Friday not only determines 
that many veterans likely contracted Legionnaires' Disease 
through the Pittsburgh VA Healthcare System, but that 
tragically five veterans have died over the past two years from 
Legionnaires' Disease acquired at the hospital.
    The CDC report paints a more complete picture and it turns 
out that problems originated much earlier than the VA has 
stated and are much more widespread.
    While VA's public acknowledgment of Legionella bacteria in 
the water at Pittsburgh VAMC did not occur until November 2012, 
the Subcommittee in the course of its investigation uncovered a 
great deal of evidence that officials at the Pittsburgh VAMC 
were aware of the serious problems with their water 
sterilization system well before this time.
    What is more, this outbreak was more than likely 
preventable. This event is rooted to the history of the special 
pathogens lab that at one time was a hallmark of the Pittsburgh 
VAMC and the flagship of Legionella research across the globe.
    Its abrupt closure in 2006 under questionable circumstances 
was followed by a congressional hearing in 2008 that led to the 
exoneration of Dr. Stout and Dr. Yu, the lab's directors, and 
the admonition of VA.
    But the loss of the special pathogens lab and the experts 
within it directly impacted VA on both a local and as well as 
on a national scale.
    According to VA's own documents, the Legionella protocol in 
place at Pittsburgh from 1997 to 2006 resulted in no hospital 
acquired Legionnaires' Disease. This protocol mandated testing 
copper and silver levels and Legionella testing every other 
month. How is it that a successful system is now blamed for the 
problems in Pittsburgh?
    VA also tells us that Legionella is a national problem. I 
agree that there should be a more comprehensive program with a 
single focal point.
    However, VA provided documents to the Subcommittee stating 
that as of December 17, 2012, there have been only five 
Legionella cases across the entire VA health care system and 
all five cases were community acquired.
    Even basic news reports tell us that these numbers are far 
from accurate. Does VA even know how many cases of 
Legionnaires' Disease exist in its patients and where they 
could have originated?
    The recent CDC report indicates VA either has no idea or is 
deliberately downplaying what actually happened. The deaths of 
five veterans and the many other cases of Legionnaires' Disease 
are nothing to be downplayed.
    I understand that different agencies have different 
protocols for preventing and responding to Legionella bacteria. 
It is my wish that today's discussion and the recent outbreak 
in Pittsburgh can provide an opportunity for appropriate 
agencies to put forth a unified effort to establish a national 
framework on addressing Legionella.
    From that framework, local protocols can be put in place so 
that a local facility can respond appropriately. The 
Subcommittee is not advocating for any one method of Legionella 
treatment, just that whatever proven system is put in place be 
used correctly regardless of the method.
    What happened in Pittsburgh could have been prevented and 
veterans have unnecessarily paid the price.
    I look forward to a thoughtful discussion today on what VA 
officials knew about Legionella in the water at Pittsburgh 
VAMC, when they knew it, and what actions they took to address 
this serious problem in a responsible and timely manner.
    However, I am disappointed that, despite several requests 
to VA from the Subcommittee, no one from the Pittsburgh VAMC 
who was there during the incident is here to deliver firsthand 
knowledge of events.
    Hopefully the witnesses that are here today can at the very 
least recommit to the Department following its own protocols 
and holding accountable those employees who fail to do so.
    I now yield to the Ranking Member for her opening 
statement.

    [The prepared statement of Chairman Coffman appears in the 
Appendix]

           OPENING STATEMENT OF HON. ANN KIRKPATRICK

    Ms. Kirkpatrick. Thank you, Mr. Chairman.
    Because they have already paid the price, we must fight for 
our veterans with all our might. Today this Subcommittee will 
examine the sufficiency and efficacy of the Veterans Health 
Administration's policies and protocols on the prevention of 
Legionnaires' Disease.
    We will also scrutinize the actions and follow-up measures 
that the Department of Veterans Affairs took once it learned of 
the outbreak.
    In December 2012, we were informed by the VA that there had 
been an outbreak of Legionnaires' Disease at the VA Pittsburgh 
Healthcare System. VA had identified a total of 29 cases of 
veterans with Legionella pneumonia with five of those cases 
having originated in the hospital. I am sad to say that five 
patients have since died.
    Legionnaires' is a deadly disease. I am sure everyone here 
would agree that we must ensure every precaution is taken to 
mitigate the risk of exposure both for the veteran patients and 
employees.
    It is my understanding that the VA Office of Inspector 
General is not only reviewing the VA Pittsburgh Healthcare 
System, but they have also begun a national review of 
Legionnaires' Disease at Veterans Health Administration 
facilities. I look forward to reading both reports.
    Because of this unfortunate outbreak, our attention has 
been drawn to really focus on the sufficiency of the policies, 
protocols, and guidelines that are available to the VA medical 
facilities about the prevention of Legionella.
    In a recently released trip report on the Pittsburgh 
facilities, the Centers for Disease Control reported that 
Pittsburgh had a large number of health care associated 
Legionnaires' Disease cases during 2011 and 2012 and widespread 
Legionella in the hospital's potable water system.
    I understand that Pittsburgh VA was recognized as the 
leader in Legionella research and was considered a model for 
control and prevention, even providing Legionella services for 
VA facilities nationwide. Indeed, they had no hospital acquired 
cases from 1997 to 2006.
    In testimony, Dr. Stout, who established the program at 
Pittsburgh, attributes the recent outbreaks to inadequate 
Legionella testing of the water and inadequate monitoring for 
ionization levels.
    I am troubled by this. If it turns out to be true, that 
means that the current outbreak could have been avoided had 
someone done their job properly.
    Further, it begs the question when did Pittsburgh actually 
learn of Legionella in the water, what steps did they take to 
mitigate it, did Pittsburgh alert the National Office of the 
Legionella in the water, why were patients and VA employees not 
notified earlier that a problem may have existed? Looking back, 
were the decisions that were made rational responses to a 
developing crisis?
    Finally, I would hope by the end of this hearing to come to 
a better understanding of what actually happened, when it 
happened, where failures occurred, and how we can fix it.
    With that, Mr. Chairman, I yield back.
    Mr. Coffman. Thank you, Ranking Member Kirkpatrick.
    I ask that all Members waive their opening remarks as per 
Committee's custom. However, I understand that one of our 
visiting colleagues, Congressman Doyle, is going to have to 
depart early, and since his constituents are directly impacted, 
I will yield five minutes to him for opening remarks.
    Mr. Doyle.

              OPENING STATEMENT OF HON. MIKE DOYLE

    Mr. Doyle. Thank you, Mr. Chairman.
    And I want to thank you and Ranking Member Kirkpatrick for 
allowing me to address the Subcommittee and today's witnesses.
    I served on this Committee for six years. The Veterans' 
Affairs Committee is a great Committee.
    As many of you know, I represent the city of Pittsburgh and 
the events in the last several months have been of great 
concern to our community, myself included.
    As disturbing reports about the Legionella outbreak at the 
Pittsburgh VA began to break in the local media late last year, 
I, along with my colleague and friend, Tim Murphy, contacted 
the Veterans' Affairs Committee to request a hearing. And I am 
extremely thankful to the Committee's swift action on this 
issue.
    I want to start off by saying that in the 18 years that I 
have represented Pittsburgh in Congress, the Pittsburgh VA has 
been an asset to my community and my constituents. The VA, its 
doctors, its nurses, its volunteers serve our veterans with 
top-of-the-line care.
    I frequently speak to veterans in my district and I 
constantly hear great stories from them about the care they 
receive at Pittsburgh VA. And as our soldiers return from tours 
abroad, providing the best care to those who have served our 
country has never been more critical.
    My father was a hundred percent service-connected disabled 
vet who received excellent care at Pittsburgh VA in the 1950s 
and 1960s, so we know firsthand as a family about the good care 
that comes from Pittsburgh VA. And I am proud to represent the 
facility.
    But having said that, we are all here today with the same 
goal, to get to the bottom of a very clear failure of water 
testing and treatment at Pittsburgh VA. This tragic incident 
resulted in the death of at least one veteran and possibly four 
more at VA. This is simply unacceptable.
    It is my hope that today we can start getting some of the 
much needed answers. It is critical that Pittsburgh VA clarify 
both for this Committee and the victims' families, some of whom 
are here, exactly what happened.
    The questions must be answered. When did the VA know that 
there were unacceptable levels of Legionella bacteria in the 
water? What did they do about it once they knew? And was that 
response appropriate? And perhaps more importantly, was this an 
isolated incident or does VA need to develop and mandate better 
standards for testing and treatment of water at its facilities 
across the country?
    I think these are relatively simple questions that we need 
answers to. It is my hope that not only do we leave here today 
with a greater understanding of the events as they occurred, 
but also with a plan to move forward.
    This tragic series of events makes clear that we need a 
better set of best practices when dealing with Legionella. 
Clearly this is a regionally significant issue for southwestern 
Pennsylvania, and I hope that this Committee and the testimony 
of these witnesses will help us move forward with a protocol to 
prevent future outbreaks in my region and across the country if 
it turns out that this is not an isolated incident.
    Mr. Chairman, I apologize that my duties on Energy and 
Commerce require me to be at a hearing which has started also 
at ten o'clock, but I know that my colleague, Tim Murphy, is 
here to ask questions on both of our behalf. My staff will be 
staying here for the entire hearing. I look forward to finding 
out what we learn here today and reviewing what the 
Subcommittee learns.
    And I want to just close by once again, Mr. Chairman, thank 
you and the Ranking Member for agreeing to hold this critical 
oversight and investigation hearing and allowing me the 
privilege to once again address the Veterans' Affairs 
Committee.
    Thank you very much.
    Mr. Coffman. Thank you, Congressman Doyle.
    With that, I invite the first panel to the witness table. 
On this panel, we will hear from Dr. Robert Jesse, Principal 
Deputy Under Secretary for Health at the Department of Veterans 
Affairs.
    Dr. Jesse is accompanied by Mr. Mike Moreland, Network 
Director for VISN 4, and Dr. Gary Roselle, Chief of Medical 
Service and Program Director for Infectious Diseases at the 
Department of Veterans Affairs.
    We will also hear from Dr. Lauri Hicks, Medical 
Epidemiologist at the National Center for Immunization and 
Respiratory Diseases with the Centers for Disease Control and 
Prevention.
    Both of your complete written statements will be made part 
of the hearing record.
    Dr. Jesse, you are now recognized for five minutes.

 STATEMENTS OF ROBERT JESSE, PRINCIPAL DEPUTY UNDER SECRETARY 
FOR HEALTH, U.S. DEPARTMENT OF VETERANS AFFAIRS ACCOMPANIED BY 
  MIKE MORELAND, NETWORK DIRECTOR, VISN 4, U.S. DEPARTMENT OF 
  VETERANS AFFAIRS, AND GARY ROSELLE, CHIEF, MEDICAL SERVICE 
   PROGRAM DIRECTOR, INFECTIOUS DISEASES, U.S. DEPARTMENT OF 
VETERANS AFFAIRS; LAURI HICKS, MEDICAL EPIDEMIOLOGIST, NATIONAL 
 CENTER FOR IMMUNIZATION AND RESPIRATORY DISEASES, CENTERS FOR 
                 DISEASE CONTROL AND PREVENTION

                   STATEMENT OF ROBERT JESSE

    Dr. Jesse. Thank you, sir.
    Chairman Coffman, Ranking Member Kirkpatrick, and Members 
of the Subcommittee, and I would add Members representing 
constituents in the Pittsburgh area, thank you for the 
opportunity to speak to you today about the causes of 
Legionnaires' Disease identified at the Department of Veterans 
Affairs Pittsburgh Healthcare System.
    I am accompanied, as mentioned, by Mr. Michael Moreland, 
who is the Director of the VISN Integrated Service Network 4, 
and Dr. Gary Roselle, the National Director for VA's Infectious 
Disease Program.
    VA takes the prevention of Legionella serious and has 
partnered nationally and locally to understand and control 
Legionella related illnesses.
    The current situation in Pittsburgh is complex and not 
fully understood. But regardless, we express our deepest 
regrets to the affected patients and we pledge that we will do 
whatever is necessary to implement corrective actions that 
might prevent this from happening again.
    Legionnaires' Disease is a form of pneumonia caused by the 
bacteria Legionella commonly found in water sources. It is 
typically associated with the water supply building since warm 
water is most conductive to bacterial growth.
    Individuals become ill after inhalation of water droplets 
containing Legionella usually within two to 14 days after 
exposure. It is important to note that Legionella is not 
contagious. The bacteria is not transmitted from person to 
person.
    Controlling Legionella in water distribution systems 
requires active surveillance of both the environment and of 
clinical infections and is balancing the risk of bacterial 
growth with the potential for scalding by hot water.
    To mitigate the latter, VA Pittsburgh has a copper- silver-
ion system to further suppress Legionella growth to maintain a 
lower hot water temperature and prevent scalding.
    Pittsburgh routinely tests water for the presence of 
Legionella, and over the spring and summer of 2012 performed 
remediation protocols to the water systems because of positive 
findings.
    Despite this remediation from August of 2012 through 
September, they identified patients with pneumonia who tested 
positive for Legionella who might have become infected while 
receiving care.
    Pittsburgh retested its water system again and the presence 
of Legionella was again confirmed and the system was again 
remediated.
    Additionally, Pittsburgh worked through the local and state 
public health authorities to engage the Centers for Disease 
Control and Prevention, CDC, and request gene typing to compare 
the Legionella from these patients with the environmental 
samples. The testing results that showed a relationship became 
available October 31st and Pittsburgh requested assistance from 
the CDC.
    A team comprised of staff from Pennsylvania Department of 
Health, the Allegheny Health Department, and CDC arrived at 
Pittsburgh on November 7th, 2012. Based on their findings, CDC 
recommended immediate remediation of the potable water system 
and Pittsburgh promptly implemented an aggressive multi-phase 
remediation effort including again super heating the water 
supply to 167 to 170 degrees followed by hyper-chlorination of 
the hot water distribution system.
    For safety reasons, Pittsburgh restricted patients' 
exposure to potable water until testing results indicated that 
Legionella mitigation was completed. These restrictions were 
lifted at the University Drive campus on November 30th and the 
Heinz campus on December the 7th.
    Pittsburgh will continue to test the water at various 
locations in the distribution system every two weeks per CDC 
recommendations.
    Pittsburgh also took its existing copper-silver ionization 
system off-line and to assure that patient care remained 
uninterrupted temporarily installed a continuous chlorine drip 
to maintain control of Legionella levels until a long-term 
definitive plan is implemented.
    VA recognized the need for transparency and an incident 
command and call center was activated to communicate news and 
updates to veterans, staff, and family members.
    Additionally, Pittsburgh attempted to contact all known 
veterans diagnosed with Legionella but whose sources of 
infection was unknown to offer those individuals testing of 
their home water systems.
    In response to Legionella cases, the Pittsburgh VA has 
implemented a number of system-wide control strategies 
including the reemphasizing with all networks and medical 
center directors the requirements regarding Legionella 
prevention.
    The under secretary for Health has directed site visits by 
VA's medical inspector starting with those having transplant 
programs being the centers at highest risk.
    Currently, VA is updating its directives regarding 
Legionella which will incorporate the lessons learned from the 
activities going on in Pittsburgh now, new scientific evidence, 
recommendations from the CDC, and current industry standards.
    This is a very complex issue and we greatly appreciate the 
support of the CDC, Allegheny County, the State of 
Pennsylvania, the Joint Commission, and others who have visited 
with us.
    The assistance helped us validate that we have taken the 
necessary steps to effectively reduce Legionella to ensure 
safety and protection of our patients at all facilities.
    We are committed to the prevention of Legionella infection 
and we will continue to update our practices as well as seek 
expert consultation and analysis to provide the best care for 
veterans.
    I thank the Committee for the opportunity to appear before 
you today to discuss this important issue, and my colleagues 
and I are ready to address your questions. Thank you.

    [The prepared statement of Robert Jesse appears in the 
Appendix]

    Mr. Coffman. Dr. Hicks, you are now recognized for five 
minutes.

                    STATEMENT OF LAURI HICKS

    Dr. Hicks. Good morning, Mr. Chairman and other 
distinguished Members of the Committee.
    My name is Lauri Hicks and I am a medical officer at the 
Centers for Disease Control and Prevention within the 
Department of Health and Human Services.
    Thank you for this opportunity to speak to you today about 
CDC's investigation into the Legionnaires' Disease outbreak at 
the VA Pittsburgh Healthcare System or VAPHS.
    I want to extend my deepest sympathies to the patients and 
their families affected by this outbreak.
    I will provide background on Legionnaires' Disease, CDC's 
role in responding to outbreaks, details regarding the findings 
of the investigation, and our recommendations.
    Legionella bacteria are often implicated in outbreaks 
associated with building water systems. Exposure to Legionella 
occurs when a person inhales water droplets containing the 
bacteria. Most people who are exposed do not get sick. Persons 
with underlying lung disease, a history of smoking, and immune 
suppression are at higher risk.
    Legionella causes a severe form of pneumonia called 
Legionnaires' Disease. While treatable with antibiotics, five 
to 15 percent of patients die.
    The CDC's Legionnaires' Disease Program supports public 
health partners and hospitals by providing assistance through 
consultations and field investigations or Epi-Aids. And these 
are conducted with the goal of controlling and preventing 
outbreaks.
    On October 12th, CDC received two isolates from the 
Pennsylvania Bureau of Laboratories obtained from VAPHS 
patients who had Legionnaires' Disease and one environmental 
isolate from the hospital.
    On October 29th, CDC reported preliminary results 
indicating a link between the two patients and the hospital. 
The Pennsylvania Department of Health requested an Epi-Aid.
    With the agreement of VAPHS on November 6th, CDC sent a 
team to Pittsburgh. The field investigation began on November 
7th and the last member of our field team left on November 
16th.
    The objectives of our investigation were to identify and 
characterize cases of Legionnaires' Disease, complete an 
environmental investigation, and recommendation interventions 
to prevent ongoing disease transmission.
    We conducted case finding by searching medical and public 
health records for cases of Legionnaires' Disease at VAPHS in 
2011 and 2012. We identified five definitely and 16 probably 
health care associated cases for a total of 21 cases. Five 
patients died.
    The 16 probable cases were among patients who were only in 
the hospital for part of their exposure period which means they 
could have been exposed somewhere else.
    Our environmental investigation revealed that 29 of 44 
samples collected from the hospital water system grew 
Legionella. The outbreak strain was widespread.
    VAPHS used copper-silver ionization to disinfect its water 
system. We measured copper and silver ions in 11 samples and 
found that mean copper and silver levels were within the 
manufacturer's recommended ranges. All 11 samples showed growth 
of Legionella and nine were positive for the outbreak strain 
indicating that the copper-silver ionization system was not 
controlling Legionella growth at the time of our investigation.
    In summary, the CDC investigation identified an outbreak of 
health care associated Legionnaires' Disease during 2011 and 
2012. The outbreak occurred in the setting of a Legionella risk 
reduction program consistent with the national Veterans Health 
Administration and the local health department guidelines.
    Factors contributing to this outbreak included, one, 
persistence of a dangerous strain of Legionella in the water 
despite copper-silver ionization.
    Two, reliance upon the VHA directive action thresholds. 
Cases occurred despite Legionella levels in the water system 
that were below the action threshold. CDC guidelines recommend 
eradication of Legionella from the water as there is no known 
safe level.
    Three, construction on hospital campus likely reduced 
incoming chlorine in the water, thus promoting Legionella 
growth.
    And, four, the hospital believed that their Legionnaires' 
Disease cases were not health care associated.
    CDC made recommendations to VAPHS to stop disease 
transmission including super-heating and hyper-chlorinating the 
building water system. They also recommended limiting patient 
exposure to the water and enhancing their Legionella risk 
reduction program.
    The hospital was very cooperative and immediately 
implemented our recommendations to protect patients. The steps 
taken by the hospital were successful and no further cases of 
health care associated Legionnaires' Disease have been 
detected.
    CDC will continue to provide support to VAPHS on an as-
needed basis.
    Thank you, and I am happy to answer your questions.

    [The prepared statement of Lauri Hicks appears in the 
Appendix]

    Mr. Coffman. Mr. Moreland, were you aware that Legionella 
was identified in the facility over the Labor Day weekend in 
September 2012?
    Mr. Moreland. Yes, sir. When I look at the data for the 
water sample testing over multiple years, it is not uncommon to 
find Legionella in the water.
    What is required then is that immediate response to that 
occurrence of the Legionella in the water which includes heat 
and flushing and also going to the areas where you find it and 
chlorine washing and cleaning it.
    And over the years, we have had samples that have positive, 
we have taken that action.
    Mr. Coffman. Mr. Moreland, did you know that your employees 
were caught falsifying copper level data in December 2011?
    Mr. Moreland. I am not aware of anyone falsifying data 
about the copper-silver levels.
    Mr. Coffman. Mr. Moreland, between June 2011 and September 
2011, VA Pittsburgh had at least two Legionella incidents.
    Did VA issue any written alerts to physicians, staff, or 
patients so that they could protect themselves and the 
patients?
    Mr. Moreland. Over the course of many years, we have had 
situations where we had Legionella identified in the water and 
took remediation action.
    We have had anywhere between two and eight diagnosed 
Legionella cases pretty much every year going back as far as I 
can find the data back to 2000----
    Mr. Coffman. Please answer the question.
    Mr. Moreland. And----
    Mr. Coffman. Would you like me to repeat the question?
    Mr. Moreland. Yes, please.
    Mr. Coffman. Okay. Between June 2011 and September 2011, VA 
Pittsburgh had at least two Legionella incidents.
    Did VA issue any written alerts to physicians, staff, or 
patients so that they could protect themselves and the 
patients?
    Mr. Moreland. There was no written alert at that time.
    Mr. Coffman. Dr. Hicks, the Pittsburgh VA microbiology 
laboratory is CDC certified for Legionella environmental 
testing, yet it failed to detect Legionella during routine 
testing and used out-of-date methods.
    How is it possible that a lab with a CDC ELITE 
certification could fail so miserably and yet retain CDC 
certification? If this can happen, what is the value of the 
ELITE certification?
    Dr. Hicks. Thank you, Mr. Chairman.
    Actually, during our investigation when we reviewed reports 
of the laboratory testing that had been done on the 
environment, we actually found that the lab was quite capable 
of detecting Legionella in the environment. And they repeatedly 
detected Legionella in the environment.
    So I am not sure why there is a perception that Legionellae 
were not being detected. They were. They routinely tested their 
water for Legionella and they routinely found Legionella.
    And it is my impression that the volumes they were 
collecting were somewhat smaller than what CDC recommends. So 
CDC recommends collecting a liter volume sample as opposed to a 
100 milliliter sample which was what the VA was using at the 
time.
    What we did when we arrived on-site is we actually compared 
our results. We sampled in tandem. We had the infection 
prevention folks sample along with us. And they used a liter 
water sample and we used a liter water sample. And their lab 
was quite capable of detecting Legionella throughout the 
system.
    So they have always been able to detect Legionella. And I 
am a little perplexed as to why there is a perception that they 
were not detecting Legionella. They were finding Legionella. It 
was just below the action threshold that they usually use for 
taking action.
    Mr. Coffman. But is it correct that no amount of Legionella 
is positive?
    Dr. Hicks. So CDC recommends that when you find Legionella 
in a water system that you do everything possible to eradicate 
it because we know of no known safe level of Legionella.
    However, in the VHA directive and in several published 
reports recommend using a 30 percent threshold. That means a 
threshold of 30 percent of sites positive in order to initiate 
action.
    And so I think what happened here is that folks on the 
ground felt like they had a false sense of security because 
they were receiving test results back. They knew they had 
Legionella, but their levels of Legionella were typically below 
30 percent and below that action threshold recommended to take 
widespread action to remove Legionella from the system.
    I think it is really important to note that we compared an 
old strain from 1982, actually a couple of old strains from 
1982 to strains from this outbreak in 2012 and what we found is 
that old strain was almost the same strain from 1982 all the 
way to 2012.
    So it indicates that in the system, there has been a 
persistent outbreak strain that has never been eradicated.
    Mr. Coffman. Ranking Member Kirkpatrick.
    Ms. Kirkpatrick. Thank you, Mr. Chairman.
    Thank you for your testimony today.
    Many of you know that I have a background as a hospital 
attorney and so this is, a very serious concern of mine.
    Dr. Jesse, I want to start with you. In your written 
testimony, you say there has been a 217 percent increase in 
Legionella from 2000 to 2009.
    To what do you attribute that?
    Dr. Jesse. That actually is data from the CDC. It is 
national data about the incidence of Legionella in this 
country.
    Now, it is important to note that over that time, the 
sensitivity, the capability to test for Legionella has improved 
and, frankly, the sensitivity, the awareness of the need for 
testing, I think, has become more common.
    Ms. Kirkpatrick. So you just attribute that not to more 
cases but increased surveillance?
    Dr. Jesse. Well, it may be more cases, but Legionella 
historically is, at least the perception is that it is under 
reported because if you do not test for it, you do not see it. 
It is particularly difficult to grow.
    As was mentioned, there is a certification for labs that 
actually do culture it. There is a urine test that one can look 
for a urinary antigen for Legionella. But in many instances, 
patients show up with respiratory symptoms and they are simply 
put on antibiotics. And it is not necessarily followed through.
    And it has been a practice at Pittsburgh to pretty 
aggressively test patients for Legionella because we know that 
is a problem there.
    Ms. Kirkpatrick. Dr. Jesse again, would you explain the 
hierarchy of the personnel who are responsible at the facility 
level for maintaining the system to keep the growth of 
Legionella under control? So can you just explain from the 
bottom up how that is reported and who is responsible?
    Dr. Jesse. If it is okay with you, I would defer that to 
Mr. Moreland.
    Ms. Kirkpatrick. That is fine.
    Dr. Jesse. Okay.
    Ms. Kirkpatrick. Mr. Moreland.
    Mr. Moreland. Yes, ma'am. The system of control for 
Legionella, as the CDC said, at Pittsburgh is very 
comprehensive. And so you have the engineering department who 
is looking at the water and managing the water.
    Then you have a group of infectious disease professionals 
who are reviewing the copper-silver ionization levels. They are 
reviewing the water samples and they are looking at that. So 
that is their surveillance of the environment.
    And then you also have the infectious disease docs looking 
at the incidence of Legionella diagnosed pneumonia.
    So it starts with there is an engineering group and the 
infectious disease group. They meet as a committee in a group.
    So the next level is a committee of infectious disease. And 
on that committee you have clinical professionals and the 
engineering group and they talk about this at every meeting 
every other month all through the year.
    They feed that information to the clinical administrative 
group which is chaired by our chief medical officer at the 
hospital and they review that data at the Executive Clinical 
Leadership Board. And ultimately that is passed to the hospital 
director who oversees the entire operation.
    And then finally, it comes to me as the VISN director who 
is overseeing the system across the ten VA hospitals in VISN 4.
    Ms. Kirkpatrick. How often do you get those reports?
    Mr. Moreland. I generally do not see the reports unless 
there is an issue. And so when the medical center director 
identifies that there is a concern, then they inform me. And I 
get those kind of reports when there is an issue of concern.
    Ms. Kirkpatrick. When did you first receive the report on 
this facility?
    Mr. Moreland. Yeah. The first time that I heard about a 
concern at VA Pittsburgh was in the fall of 2011. And in that 
fall of 2011, there were several diagnosed cases not confirmed 
as hospital acquired but several diagnosed cases.
    And at that time, the VA Pittsburgh sat down and did a very 
structured situational review, what was going on, what 
happened. They made some changes to the system. And rather than 
rely on the 30 percent rule, for example, they decided if we 
find Legionella anywhere, we will do a heat and flush. So they 
made some changes to that.
    They made some changes to their preventative maintenance of 
the copper-silver ionization system stepping up and above and 
beyond what the manufacturer guidelines were. They called in 
the manufacturers to say let's talk about this and how does 
this work and make sure that they knew what was happening. And 
they made some changes to that.
    And the clinical group on the infectious disease stepped up 
their work. For five months after that, we had no cases. The 
assumption was the actions that we took care of the issue.
    And so it was not then until months later that we again saw 
some cases and this time when it happened, the infectious 
disease professionals came to the chief of staff, that next 
level, came to the hospital director, came to me and said we 
see this happening again, we are surprised. We think we need 
some help.
    And that is when we initiated our actions to go to the CDC 
and say come help us, we want to make sure we are on top of 
this.
    Ms. Kirkpatrick. Would it have been possible at any time 
just to change your water system, for instance, bring in 
bottled water or something just to make sure that it was not 
spreading to the patients?
    Mr. Moreland. And this is where, you know, when you look at 
data in a 12-month window, you only see 12 months. This is 
pretty typical what happens over going back to at least 2003 
when I have looked at the data. And so it is not unusual to 
have water in the--have Legionella in the water and then you 
remediate and you move forward and you do not see cases.
    That is kind of what happened. We did have a hospital 
acquired case in 2005. We did have a hospital acquired case in 
2007. The difference in this episode is that we had three cases 
in the fall. And that is why I think the hospital director 
called me and I said absolutely call the CDC because it was 
something different and unusual. And so a different response 
was required and that is why we called the help chain.
    Ms. Kirkpatrick. I appreciate your answer, but I do not 
think you completely answered my question which is, why not use 
an alternate water source? Why not bring in bottled water or 
something else during that investigation stage?
    Mr. Moreland. Yeah. You know, when you look back, that 
might have been something to consider. But, you know, at the 
time, the professionals that we were dealing with, the 
infectious disease docs, we did not think that it was at a 
level of danger to be worried.
    Remember, it is not the drinking of the water. It is the 
inhalation of the fumes, of the droplets. And so you can drink 
the water and it is not an issue. The problem is when you 
breathe it and inhale the droplets. So that is why that.
    But the reason we used bottled water was actually because 
we were hyper-chlorinating the water. It was not about the 
Legionella. It was about the hyper-chlorination.
    Ms. Kirkpatrick. What efforts were made to notify the 
providers that this was an issue?
    Mr. Moreland. Well, when we finally confirmed that there 
was hospital acquired cases, not only did we inform the 
providers, but we went on the Internet and put it on the 
hospital's Web page. We issued a fact sheet. The hospital 
director called each of the union presidents to talk to them to 
make sure they knew what was going on. We sent out an all 
employee news blast.
    You know, it happened once we had confirmed and knew that 
we had a real problem and that was November the 14th, I think, 
when CDC gave us the final report that confirmed that there was 
really a problem.
    Ms. Kirkpatrick. Thank you.
    I may have additional questions, but I will submit those in 
writing. Thank you.
    Thank you, Mr. Chairman.
    Mr. Coffman. Dr. Roe.
    Mr. Roe. Thank you, Mr. Chairman.
    First, I want to complain a little bit about getting 
written testimony on a Monday night. I have seen this happen 
over and over again and it is very frustrating for me. I 
actually read these things. And I cannot read them if I do not 
get them.
    So I almost did not come to this hearing because there is 
no point in me being here and wasting my time if I have not had 
a chance to prepare. So that is just a bit of frustration.
    Number two, Saturday I went to a basketball game in Johnson 
City, Tennessee where we have a VA. And I presented basketballs 
to five wounded warriors there at halftime. And a soldier 
expects to be at risk when they are on the battlefield. They do 
not expect to be at risk when at a VA hospital. We expect to be 
at risk for our lives then, but we are there to help them at 
the VA.
    And I see some real shortcomings here and I have several 
questions I would like to ask.
    And, Dr. Hicks, you said that the VA was complacent. And I 
know you have had a system. When you said that same strain of 
Legionella had been there since 1982, they obviously had a 
system from many years where no cases of Legionella were 
detected.
    So I think in just listening to this testimony, I do not 
know, it sounds like that you may have had a sampling error. I 
did not realize you used a 30 percent, 30 percent of the disks 
had to be positive for you to consider there to be a problem.
    And when you only test this much volume versus that much 
volume, when there is not much bacteria in there to start with, 
that may have--do you think that is the reason why or why did 
they become complacent? Was it the ten years or so of no cases? 
And whatever they were doing, they obviously were doing it 
correctly.
    Dr. Hicks. Yeah. It is my perception that they had a false 
sense of security. They were under the impression that they had 
Legionella control in the environment because they had a 
copper-silver ionization system in place.
    And when we were on-site, we measured those levels. Those 
levels were adequate. And we looked at the maintenance of the 
system while we were on-site and at the----
    Mr. Roe. Let me stop you there. And obviously you are the 
expert here.
    Dr. Hicks. Uh-huh.
    Mr. Roe. Is that a bad system? I mean, it worked for ten 
years----
    Dr. Hicks. Yeah. I----
    Mr. Roe.--with no cases. And so now you say the levels are 
all fine. That gives me a very bad feeling because then what 
metric do I use?
    Dr. Hicks. I think that is a question that we would like to 
look into more. We have not had many opportunities to really 
evaluate the system. This was actually our first field 
investigation into an outbreak where there was a copper-silver 
system.
    But we do receive over 200 consultations each year related 
to Legionella. Many of them are related to troubles controlling 
Legionella in the environment and many of those are related to 
concerns about copper-silver----
    Mr. Roe. Here is where I think the antenna should have been 
up. And when you are in a big system seeing a lot of people and 
incidence of something is so small, I understand that, but an 
outbreak is defined as two or more cases.
    Dr. Hicks. Uh-huh.
    Mr. Roe. That is all. And the same bug and the same 
environment, that happened and that was the antennas apparently 
did not go up.
    Dr. Hicks. Uh-huh.
    Mr. Roe. So why do you think that was?
    Dr. Hicks. It goes back to the perception that they were 
doing everything they could to control Legionella in the 
environment. And when they were testing their water, they found 
levels that were below the 30 percent threshold that calls for 
action.
    Mr. Roe. And I do not want to delve on this too long, but 
have other VAs, have you seen this elsewhere because if it is, 
then you have got a system that does not work?
    Dr. Hicks. In terms of the copper-silver system?
    Mr. Roe. Yeah.
    Dr. Hicks. I have not personally done a field investigation 
into copper-silver system ionization, but we have received 
anecdotal reports from other facilities that have also had 
trouble with it, yes.
    Mr. Roe. Well, then I think that is a metric that needs to 
be looked at certainly if that is the case.
    I think one of the things that also, and this is not in any 
of the testimony because I did not get it, but I was reading a 
news report, and Dr. Murphy may have some more information on 
this, but one of the family members was asked to go home and 
test their water.
    Dr. Hicks. Uh-huh.
    Mr. Roe. And I think that that family member felt like that 
they may have caused the--and that was very wrong to do that 
when you knew you had an outbreak right there in your own shop. 
I do not understand that. And, I mean, that is now putting the 
blame on me that I did something to my dad to cause his death. 
And that is not the case at all it turned out.
    Dr. Hicks. Yeah. I mean, I think it is very----
    Mr. Roe. You mentioned that early.
    Dr. Hicks. Yeah.
    Mr. Roe. And I think we do owe these families an apology. 
And I know that people were trying. I mean, I understand that. 
I am not here--people--I mean, good, smart people were out 
there trying to do that.
    Dr. Jesse, why aren't the people who were involved in 
actually doing that here? Why are you here? I mean, because if 
I had a problem in the operating room, I would want to talk to 
the surgeon who did the surgery.
    Dr. Jesse. Well, sir, I am here in my role as a principal 
deputy under secretary having oversight over----
    Mr. Roe. I think that is fine.
    Dr. Jesse.--the system. There was----
    Mr. Roe. And I appreciate you being here, but my question 
is, where are the people who actually were involved in doing 
this? They should be the ones who are here.
    Dr. Jesse. Well, there is a huge team of people that are 
involved in this. It is the building engineers, as you have 
heard. It is the----
    Mr. Roe. You can--you can----
    Dr. Jesse.--infection control folks. It is the hospital 
staff.
    Mr. Roe. Dr. Jesse, when I go to the operating room, there 
are huge numbers of people there, too, but I know who is 
responsible, me.
    Dr. Jesse. Right.
    Mr. Roe. It is not the scrub nurse, the anesthesiologist, 
and all those other people. There is somebody that is 
responsible at the top. That is who should be sitting here.
    I yield back.
    Mr. Coffman. Mr. Walz.
    Mr. Walz. Well, thank you, Mr. Chairman.
    And, first of all, congratulations to you and your 
Chairmanship, and to the Ranking Member. I appreciate the work 
you do.
    Mr. Coffman. Thank you, Sergeant Major.
    Mr. Walz. I would also like to comment on the very proud 
work and I think from institutional knowledge of this Committee 
several years ago, Dr. Roe under his leadership initiated a 
very similar hearing on contamination of medical instruments, 
of colonoscopy scopes, for example, which led to not only best 
practices and changes in that, but it went systemwide 
throughout the country as a best practice.
    So I appreciate the spirit that this is being held and 
trying to figure that part of it out.
    Dr. Hicks, could you explain to me how the protocols at the 
VA compare to their civilian counterparts in the region and 
maybe nationally? I understand this is more of a geographic 
issue to a certain degree, but could you explain to me, is 
there a difference there or is there a uniform protocol?
    Dr. Hicks. Okay. There is a VHA directive that has been in 
place since 2008, I believe, and we also have a CDC guideline 
for prevention of health care associated Legionnaires' Disease. 
And there are some differences.
    One thing I would mention before I get into the differences 
is that most health systems in this country do not have a 
prevention plan at all. And so I think it is important to 
recognize that the VA is ahead of the game because they do have 
a prevention plan. They do require that hospitals have a 
written prevention plan and all their hospitals have to comply 
with this.
    This hospital had a plan, but it goes to show you that 
policies are not necessarily full proof. And so in this 
situation, we looked at the VHA directive and we compared the 
directive to our policies. And there are some areas where we 
would recommend some changes and we are going to be looking 
forward to working with the VHA colleagues to make those 
changes.
    The one area that I think is probably most critical is this 
threshold, action threshold level. So throughout the directive, 
there is mention of an action threshold. And it implies that if 
your testing reveals that you are below 30 percent, then you 
will not have health care associated cases or you will not be 
at risk for health care associated cases.
    And in our experience, that has not been the truth or not 
the case. We have actually investigated several outbreaks where 
we found fewer than 30 percent of sites colonized.
    And, in fact, this situation perfectly illustrates why that 
policy does not work because the VA repeatedly detected fewer 
than 30 percent of sites colonized over and over again. So they 
thought that they had their Legionella problem under control.
    So that was a big issue that I think we really need to work 
on together. The other issue has to do with the volume of 
sampling. And CDC typically uses a liter volume when we sample 
and that increases our ability to detect Legionella when we are 
doing an investigation.
    Mr. Walz. Was this an issue here that the sample size was 
too small?
    Dr. Hicks. From what I can tell you, I do not think it made 
a big difference in the ability to detect Legionella in the 
long run. I do not think it plays a huge role in this 
particular outbreak because they were detecting Legionella even 
with the smaller volume.
    Mr. Walz. Then the question I was going to ask on this, I 
understand it is this issue of should we test for everything. 
You can do an X-ray for every single thing or whatever, but at 
some point the cost benefit analysis is reduced.
    Is there a point where you have these areas especially in 
the northeast or whatever? About how much does it cost to test? 
What does it cost to test?
    Dr. Hicks. Yeah. I cannot speak to the exact amount. I 
would be happy to get back to you on that. But it is expensive. 
And, of course, the larger volume you use, the more money it 
costs because it takes more money to ship the sample, so----
    Mr. Walz. Would it be just not wise to test all the time at 
these places? Would that be an unwise use of resources that 
would not detect or would not prevent?
    Dr. Hicks. Yeah. I think that in a setting where you have 
decided to use testing as your measure for your effectiveness 
of your Legionella prevention plan, I mean, you do have to 
routinely test.
    But I think it is important to note that testing is one 
parameter to measure, but there are many others that you can 
evaluate in addition to actually evaluating Legionella in the 
environment.
    So things like temperature and your disinfection levels and 
pH and chlorine, so there are----
    Mr. Walz. This issue of hospital acquired infections and 
illnesses is far broader than this issue, right----
    Dr. Hicks. It is very----
    Mr. Walz.--and all these come together?
    Dr. Hicks. Right.
    Mr. Walz. Okay. Very good.
    Dr. Hicks. This is very complex.
    Mr. Walz. My time is up. I would like to end by thanking 
all of you.
    And the question was, why are you here, Dr. Jesse. I am 
glad you are here and I know it is public health. You are a 
public health expert and I think this gets into the broader 
question obviously, I think.
    And I appreciate, Dr. Hicks, your concern. One patient 
infected that could have been prevented is one too many and it 
is very difficult to get to zero, but we have to strive for 
that. So I appreciate the spirit that you are taking that.
    I yield back.
    Mr. Coffman. Mr. Huelskamp.
    Mr. Huelskamp. Thank you, Mr. Chairman. I appreciate the 
opportunity to ask a few questions this morning.
    First, I had a follow-up with Dr. Hicks.
    You mentioned 30 years of Legionella in this facility?
    Dr. Hicks. Yes.
    Mr. Huelskamp. Are there other cases CDC is aware of where 
you have 30 years of the same strain of Legionella?
    Dr. Hicks. Well, we only conducted the investigation going 
back to 2011, so I cannot comment on cases prior to 2011. But I 
believe earlier in the testimony some folks mentioned that 
there had been other cases. So perhaps my VA colleagues can 
comment on that.
    Mr. Huelskamp. And I will follow-up with them. I am just 
curious of what you knew elsewhere given your regimen.
    Do you have a different standard or certification regimen 
if you have 30 years of persistent cases of the same strain or 
do you just treat them all the same across the board?
    Dr. Hicks. Our approach to Legionella's prevention is if 
you find Legionella in the environment, especially in a place 
where there are vulnerable patients, you must try to get rid of 
it.
    The policies that have been in place for very many years 
allowed for about 30 percent of sites to remain colonized. And 
these policies were carried forward over many decades.
    And so what I think is really important here is to 
understand that there was a perception that if you have low 
levels of Legionella in your system that you will not see cases 
of Legionnaires' Disease. And that is just not true.
    And when we tested----
    Mr. Huelskamp. Yeah. Well, it is certainly not true in this 
case----
    Dr. Hicks. Right.
    Mr. Huelskamp.--after 30 years on and on.
    Dr. Hicks. Right.
    Mr. Huelskamp. And that would be a question if I could for 
Mr. Moreland.
    How long have you been in your particular position?
    Mr. Moreland. I have been the network director since 2006.
    Mr. Huelskamp. And so this whole time you knew there had 
been at that time 24 straight years of this persistent strain 
of Legionella in this particular facility?
    Mr. Moreland. When they are talking about that particular 
strain, they are talking about the genotyping for that specific 
strain. And so not every case is necessarily from that specific 
genotype strain. But the strain that they found now, I think, 
matches six out of eight----
    Dr. Hicks. Yeah.
    Mr. Moreland.--of the chromosomes, I guess it is, for that 
strain. So it is kind of a grand daddy of a grand daddy to that 
strain. So it is a very closely related strain, but that does 
not mean that there were not different strains of pathogenic 
Legionella that occurred on occasion across the years.
    Mr. Huelskamp. And my question is, are you doing the same 
testing regimen in other facilities that do not have this 30-
year case history? Did you treat this facility any differently?
    It is my understanding elsewhere in VA, you--there is a 
facility, and I am not sure which one it is, actually does 
testing three times a week.
    How often did you do testing in this particular facility?
    Mr. Moreland. The testing at the VA Pittsburgh historically 
has been every other month and that has been not just one test 
every other month but multiple tests of multiple distal sites 
in the water system during those months.
    Now, since we have had this outbreak, we are doing it every 
two weeks and we will continue that until we have got a system 
where we believe it is stable.
    There is a lot of activity if you would like to ask about, 
you know, what are we going to do, the way forward, and how are 
we going to change because, you know, we have looked at what we 
have done and the effectiveness of what and we have decided to 
move in a different direction and use a different system for 
control.
    Mr. Huelskamp. And I appreciate that, Mr. Moreland. My 
concern, though, we have got the testing, one can argue that 
probably not enough testing, improper sample size. Also the 
question I have is remediation.
    Mr. Moreland. Right.
    Mr. Huelskamp. And can you describe very briefly the 
remediation efforts since you arrived there in 2006, how often 
they were done and clearly they were insufficient? What would 
you have done differently and did it meet the CDC standards for 
necessary remediation?
    Mr. Moreland. Yeah. The testing was done and when we found 
positive samples, we did remediation. The remediation 
included----
    Mr. Huelskamp. Only if it was over 30 percent?
    Mr. Moreland. Not necessarily. While that is the VA policy 
to, you know, to look at what level do you think, and it is not 
directed that you use the percent, but that is kind of what we 
had in your policy. However, we still did the remediation at 
lower levels.
    And as I mentioned earlier, in 2011, they decided let's do 
remediation no matter what the level. And so for at least a 
year, we have been doing remediation every time we found some 
Legionella. The remediation----
    Mr. Huelskamp. And you found Legionella every time you 
tested?
    Mr. Moreland. Not every time we tested.
    Mr. Huelskamp. No, that is not what you said earlier. Every 
test you found some level of Legionella. Is that----
    Mr. Moreland. No.
    Mr. Huelskamp.--incorrect----
    Mr. Moreland. No.
    Mr. Huelskamp.--the earlier statement?
    Mr. Moreland. Not every test was positive. We did multiple 
tests. So we may have done 15 or 20 tests and maybe three or 
four of them showed positive or----
    Mr. Huelskamp. Positive at the 30 percent level when you 
say a positive test?
    Mr. Moreland. There would be ten sites. You go out and you 
test all ten. And if there are one or two, that is less than 30 
percent. However, we would remediate those two sites anyway.
    Mr. Huelskamp. Even though it is in the same system, you 
mean?
    Mr. Moreland. Even though it is in the same system, yeah, 
because it is interesting. The Legionella can be in a dead leg 
of a pipe. It can be in the faucet. It does not have to be in 
the entire system.
    Mr. Huelskamp. And I do not know where it is. All I know is 
we have deceased veterans and their families asking for answers 
here.
    And my question is, you are now saying you have remediated 
every single time you found a sample with Legionella in it?
    Dr. Jesse. If I may give a concrete example, following----
    Mr. Huelskamp. No. I want a concrete answer. If you can 
provide it back to the Committee every time you did a 
remediation.
    And has there been independent review of all the sampling? 
Who did the sampling for you?
    Mr. Moreland. The sampling of the Legionella water samples?
    Mr. Huelskamp. Well, yeah. That is what we are talking 
about.
    Mr. Moreland. Yeah. Well----
    Mr. Huelskamp. I do not know what else we would be talking 
about. Go ahead.
    Mr. Moreland.--there is a silver test as well. But for the 
Legionella test of the water, it was done by our lab in VA 
Pittsburgh which is a certified lab. And that lab continues to 
do testing for multiple hospitals across the VA.
    Mr. Huelskamp. And they recommend the 30 percent level?
    Mr. Moreland. That recommendation of the 30 percent level 
is in the policy by the infectious disease group that is in our 
local VA policy. But despite that policy set, and it is also at 
the national policy level, despite that number, in 2011 when 
they wanted to make sure that they were doing above and beyond, 
they started doing heat and flushes and chlorine washing of the 
faucets every time at the site where they found a positive 
test.
    Mr. Huelskamp. Okay. I appreciate that.
    And I yield back my time. Look forward to a list of the 
remediation efforts tied to the testing results. Thank you.
    Mr. Coffman. Thank you, Mr. Huelskamp.
    Ms. Kuster.
    Ms. Kuster. Yes. Thank you very much, Chairman, and Ranking 
Minority, thank you.
    I have a question to follow-up on this 30 percent because 
it seems as though that is where our attention is getting 
focused.
    And I wanted to ask Dr. Jesse whether the VA has a plan to 
reevaluate the existing guidelines and policies that might not 
have been adequate when it comes to preventing Legionella or 
the outbreak of Legionnaires' and would you consider a change 
in recommendations to lower that to a zero threshold or some 
number less than the 30 percent to address what Dr. Hicks has 
described as a false sense of security?
    Dr. Jesse. Yeah. So the Legionella directive, the national 
Legionella directive is under revision now. They are completing 
their evidence review which will review all the published 
literature particularly that has been out since the last 
directive was put in place.
    And as I said earlier, that directive will be informed by 
the lessons learned from Pittsburgh as well as the emerging 
scientific evidence, consultation with CDC and others. So I can 
assure you that there will be a change in that 30 percent 
threshold.
    That directive was written in 2008 and it was informed by 
prior experience. And the experience across many years was that 
that appeared to be a safe level.
    As Mr. Moreland said, in 2011, they changed, despite the 
national policy, it does not restrict you, but they said 
because of the issues here, we're going to remediate and at one 
point even finding one of 27 samples positive they did a 
remediation process.
    Ms. Kuster. Yeah. It just seems as though this is a much 
more persistent bug than had been earlier predicted.
    And, Dr. Hicks, do you think that would be an appropriate 
change in policy that could hopefully--I mean, the purpose of 
this hearing is to protect future veterans and to spare their 
families.
    And I want to agree with my colleague on the other side of 
the aisle that we understand our troops are going to be in 
harm's way, but when we get them home safely, our goal is 
obviously to keep them safe going forward.
    Dr. Hicks. So I absolutely agree the VHA directive is 
wonderful because there is a policy in place intended to 
prevent Legionellosis. And this is a policy that has had great 
uptake, from what I understand, across the VA.
    But I do think this is an opportunity to identify where we 
can make improvements so that we can protect this very 
vulnerable population.
    Ms. Kuster. And I just have one other question and that is 
with regard to the people that are working in this facility.
    Have you had any instances of employees that have been 
stricken with Legionella or Legionella leading to Legionnaires' 
Disease? And also, what are the precautions that are being 
taken going forward because I could imagine this would be a 
stressful work environment?
    Mr. Moreland. When we sent out the notice on November the 
14th or 15th to tell everybody that we had a concern, we 
advised every employee if you have any kind of respiratory 
concern, please come to employee health. We will provide tests 
and assistance with you.
    We have had people come with respiratory concerns, but we 
have had no diagnosed Legionella of employees. The challenge is 
you have to get, you know, a clinical test to make sure it is 
diagnosed. And so there are concerns of a couple employees that 
had pneumonia, but they do not have a diagnosed Legionella 
diagnosis and that is a concern.
    My understanding is that they filed a claim with the 
Department of Labor for workmen's comp and we certainly support 
their opportunity to file that claim and doing that.
    In terms of the way forward in the water system, was that 
what you asked me?
    Ms. Kuster. Well, I am just thinking about precautions both 
for incoming patients but also particularly the people who are 
working there day in and day out, their exposure to an 
obviously very dangerous bug.
    Mr. Moreland. Yes, ma'am. I think the most important thing 
is to clear the system of the Legionella. And what we are in 
the process of doing now, in fact, just a week ago because 
since they started in November, we have been sitting down with 
experts, what do you do, how do you make things better, what we 
do in the way forward, and one of the main suggestions we have 
had is to raise the temperature in the pipes.
    And as we talked earlier, one of the challenges is when you 
raise the temperature, you have got to be careful of scalding 
patients because I do not want to be back here talking about 
scalding patients.
    Ms. Kuster. Yes.
    Mr. Moreland. And so what we have done is we have purchased 
some scald protection faucets and showerheads that we have just 
let a contract on. They will start the installation of those.
    Once those get into place, we can raise the temperature in 
the pipes to a much higher level and we believe that will add a 
higher level of suppression of Legionella. And then we will 
move forward with some consideration of other supplemental 
systems.
    Ms. Kuster. Thank you.
    Mr. Moreland. Thank you.
    Mr. Coffman. Thank you, Ms. Kuster.
    Chairman Miller.
    Mr. Miller. Thank you very much.
    I want to thank Dr. Murphy and Mr. Doyle for bringing this 
personally to my attention.
    But, Mr. Moreland, I have got a couple quick questions. Is 
it your testimony you say that this all started in November?
    Mr. Moreland. I said in November of 2011 that we had some 
concern and took remediation and then had five or six months of 
no concern. And then it returned again in the fall of this year 
and that is when we are in this current outbreak.
    Mr. Miller. And you allowed employees immediately once you 
found out that it was an issue again, that is when you told the 
employees to go ahead and report to you if they had any 
respiratory concerns?
    Mr. Moreland. Once we confirmed that there was a 
substantial outbreak in the water, yes, sir.
    Mr. Miller. How long did that take for you to confirm there 
was a substantial outbreak in the water?
    Mr. Moreland. When we got the final report from the CDC 
November the 14th of this year.
    Mr. Miller. Did you know any earlier than that before the 
final report?
    Mr. Moreland. Over the course of, and this is, I am sorry 
you missed, but over the course of years, we have had 
Legionella positive water testing.
    Mr. Miller. Oh, no. I have been here.
    Mr. Moreland. Oh.
    Mr. Miller. I apologize. I have been monitoring on the 
television as well.
    Mr. Moreland. Okay.
    Mr. Miller. Yeah. I am very well aware it has been in the 
system for a very, very long time.
    Mr. Moreland. Right. And then we have done remediation and 
cleared it and then done samples. And we have done that for 
years. So it was not really until we got the confirmed report 
from the CDC in November that we recognized that we had a very 
significant issue and took aggressive action for remediation.
    Mr. Miller. Did you suspect before you got the final report 
from CDC that you had a serious problem?
    Mr. Moreland. I think that what happened was in early 
September and into October, we had concern, but no 
confirmation.
    Mr. Miller. What did you do when you have had that concern? 
What action did you take?
    Mr. Moreland. We collected samples from the patient's 
clinical samples. We collected water samples, talked to 
Allegheny Health Department, got the information to them so we 
could get it to CDC, asked them to help us look at the 
situation. We did----
    Mr. Miller. And once that occurred----
    Mr. Moreland.--heat and flush of the water system.
    Mr. Miller. Once that occurred, who did you notify within 
the physician groups or the staff? I mean, did anybody know 
that this was happening?
    Mr. Moreland. The infectious disease group knew because 
they were the ones that were working with the local clinical 
people at the hospital.
    Mr. Miller. But the staff did not at the hospital----
    Mr. Moreland. We did not do a general----
    Mr. Miller.--the physicians did not----
    Mr. Moreland.--announcement to the staff, no.
    Mr. Miller. Because you just did not think that it was 
warranted until you had the final report from CDC or----
    Mr. Moreland. We had had these kind of concerns multiple 
times over years and done heat and flushes and had things 
resolve effectively. This time we were concerned and called 
CDC. And once we confirmed it----
    Mr. Miller. But wouldn't you want a physician to know? I 
mean, wouldn't physicians want to know that you had a concern 
that was so serious that you were bringing the Allegheny County 
Health Department? I just----
    Mr. Moreland. Well, certainly the chief of staff, the 
medical director of the hospital, the infectious disease 
community, we were working in an open environment talking about 
how to work----
    Mr. Miller. But, again, open environment to who? I guess my 
concern is----
    Mr. Moreland. Right.
    Mr. Miller.--if I had a suspicion that there was a--if I 
had had this for 20 years and I thought that there was a very 
large suspicion that it was more than what I had been coping 
with, I would have thought that I would have--but where did the 
30 percent number come from? I mean, I know you were saying the 
group, the clinical group. But, I mean, is that a written 
policy? I am interested in knowing where the 30 percent comes 
from.
    Dr. Roselle. Okay. I have heard a lot about 30 percent so 
far this morning and I think the 30 percent--first, let's talk 
about the directive because that is where the hospitals get 
their information from the VA.
    And what it says specifically is the directive specifies 
that each facility set its own threshold and that is directive 
2008-010, page 85. The directive then goes on to recommend 30 
percent and that is because in the literature, 30 percent is 
noted as a risk level. It is consistent with Allegheny County 
and many other places. So----
    Mr. Miller. I mean, is the problem any less virulent in 
Florida than in--why would you give hospitals the ability to 
set their own levels?
    Dr. Roselle. Oh, this was discussed at great length when 
this directive was written by the consensus group because there 
is no absolute data on the--while the CDC I agree with, it is 
impossible to know what a safe level is. Legionella is 
ubiquitous and it is very, very, very hard to eradicate.
    So the literature is inconsistent now, even now about what 
those numbers mean which is why we gave enough flexibility to 
the facility to set their own threshold because they know their 
pipes, they know their system.
    And, in fact, Pittsburgh did just that. When they 
considered that they had some issues, they remediated not with 
no regard to the 30 percent and did heat and flushes and all 
the things that we have been talking about.
    So the flexibility is designed for the stations because 
there are a lot of hospitals with a lot of plumbing and yet the 
30 percent is in the literature. So I think that everything 
that they did was consistent with the directive.
    Now, should there be more rigor----
    Dr. Jesse. To answer your question directly, yes, there is 
a difference between Pittsburgh, Florida, Arizona, California 
both in terms of the prevalence of the disease--the CDC will 
say that it is the mid-Atlantic, Pennsylvania, New York, New 
Jersey where it is the highest and other areas of the country 
it is significantly lower.
    And the other issue is that I think the number is 25, but 
many of our facilities get their water from municipalities who 
treat their water with monochloramine which seems to be a way 
to get it to the tap without having to do anything intervening.
    So it would not make sense to have a national policy that 
has a one-size-fits-all. The important thing is that every 
facility needs to assess its risk of Legionella. It does that 
through surveillance of both the water supply and clinical 
cases and based on that builds its strategy.
    Mr. Miller. Thank you.
    And thank you, Dr. Murphy, for allowing me to speak out of 
order.
    Mr. Coffman. Dr. Murphy.
    Mr. Murphy. Thank you, Mr. Chairman, and thank you for 
holding this hearing.
    So how often is the VA Pittsburgh required to test its 
water systems?
    Mr. Moreland. So the requirement is based on----
    Mr. Murphy. Just how often?
    Mr. Moreland. It would be absolutely required twice a year.
    Mr. Murphy. Twice a year.
    Mr. Moreland. And that would be----
    Mr. Murphy. Is every VA the same?
    Mr. Moreland. No.
    Mr. Murphy. Okay. So Pittsburgh is twice a year. Other VAs 
may be how often?
    Mr. Moreland. Other VAs may be not at all.
    Mr. Murphy. Okay. So this is based on----
    Mr. Moreland. But it is----
    Mr. Murphy. How about the CDC, how often does the CDC 
recommend hospitals test their systems?
    Dr. Hicks. So in the setting where there are transplant 
patients, we recommend that a testing protocol----
    Mr. Murphy. Just number.
    Dr. Hicks.--but there is no----
    Mr. Murphy. Once or twice a year? You do not have a 
protocol?
    Dr. Hicks. No.
    Mr. Murphy. Now, for those who are not aware, the VA system 
in Pittsburgh is in the midst of the University of Pittsburgh 
campus across the street from the huge Peterson Event Center 
where we have our basketball games, a block away or across the 
street from Western Psychiatric Institute and clinic, a block 
away from Presbyterian Hospital, a lot of transplants are done 
there, Montefiori Hospital, several hospitals nearby.
    When the CDC was looking at Legionella levels, did you 
check any other hospitals nearby?
    Dr. Hicks. No, we did not check any other hospitals nearby.
    Mr. Murphy. Do we know if they have Legionella levels that 
are a problem?
    Dr. Hicks. I know that other hospitals in the area have 
struggled with Legionellosis and it is a very common problem in 
hospitals across the country.
    Mr. Murphy. I understand that. But I am saying here we have 
one hospital here and we have several hospitals across the 
street and nobody checked for their Legionella levels. Am I 
correct?
    Dr. Hicks. Yes. Well, I do not know what their current 
policies are.
    Mr. Murphy. That is important too.
    Dr. Hicks. Yes.
    Mr. Murphy. I am just trying to find out if CDC checked and 
I would hope we would find that out because if you are going to 
do an epidemiological study, you have to find out why at one 
building and not others.
    When did Pittsburgh VA first learn they had some problem 
levels outside the normal reading levels with their copper-
silver ionization system? Do you know that, Mr. Moreland?
    Mr. Moreland. For as many years as I know, there has always 
been issues of maintaining the copper-silver level. And that is 
why they have a valve that you adjust the levels. And so if you 
look at the levels over several years, there is low levels and 
high levels and then a group of levels in the middle.
    Mr. Murphy. And to your knowledge, no one has ever caught 
any staff putting false numbers down for copper-silver 
ionization levels?
    Mr. Moreland. I have seen no such evidence.
    Mr. Murphy. Whenever there is abnormal or outside the 
normal limits of copper-silver ionization levels, does this 
increase the risk that Legionella could be surviving in the 
water systems?
    Mr. Moreland. I really do not know that. I mean----
    Mr. Murphy. Well, perhaps we will have some testimony later 
on in that. If you do not know, we will just have someone ask 
that.
    And it was first detected in the system when? What was the 
date of that when you first detected Legionella in the water 
system?
    Dr. Jesse. Legionella has been in----
    Mr. Moreland. Nineteen eighties.
    Mr. Murphy. But, I mean, during this recent outbreak 
because you had several years without Legionella cases.
    Mr. Moreland. Looking at the date from 2003 until 2012, 
there were two to seven diagnosed cases every year of 
Legionella but not hospital acquired. We had a hospital 
acquired case in 2005 and a hospital acquired case in 2007.
    Mr. Murphy. Mr. Moreland, you know I have the highest 
respect for you and the VA. And you have received national 
awards in the Veterans Administration for your work to stop 
hospital acquired infections. Something broke down here.
    And one of my concerns also is here you have some cases 
showing up and the medical staff was not notified. This is a 
serious problem.
    So you have Legionella above the 30 percent threshold. Am I 
correct in that? So the medical staff was not notified that it 
was showing above that level. But even then, we are not sure if 
this 30--you could have one percent and it could still be 
dangerous.
    Dr. Hicks. That is the point I was making. Actually most of 
the cases that occurred here were when levels were well below 
30 percent.
    Mr. Murphy. It almost sounds like in some ways it is people 
washing their hands and saying, you know what, I did not set 
the standards, there are no national standards. Everybody gets 
to make up their own standards. Thirty percent is some number 
that people pulled out, but one percent could be enough.
    And we have some people dead here and I do not hear anybody 
saying, you know what, this was wrong. The CDC and the VA and 
hospital associations nationwide are going to set some other 
standards here.
    Dr. Hicks. Uh-huh.
    Mr. Murphy. Is that going to happen?
    Dr. Hicks. One thing I would like to mention is that there 
is a new standard about to be released and the CDC has been 
working on that standard----
    Mr. Murphy. Thank you.
    Dr. Hicks.--with a number of other experts related to 
Legionella. And this standard is called prevention of 
Legionellosis associated----
    Mr. Murphy. Can I just ask something?
    Dr. Hicks. Yes.
    Mr. Murphy. Mr. Chairman, could I just be given another 
minute here because there are a couple more critical things I 
just want to ask? Would that be all right, Mr. Chairman?
    Mr. Coffman. Go ahead, Mr. Murphy.
    Mr. Murphy. When you tested the water systems at the 
Pittsburgh VA, how many different water systems are there 
within the Pittsburgh VA system?
    Dr. Hicks. It is a very complex water system.
    Mr. Murphy. Just how many?
    Dr. Hicks. Oh, I could not tell you off the top of my head. 
I would have to get back to you on that.
    Mr. Murphy. Three, four, five, six maybe, self-enclosed, 
does that sound about right?
    Dr. Jesse. I think there is four.
    Mr. Murphy. Four? There is four different systems. Did you 
test all the systems?
    Dr. Hicks. Yes.
    Mr. Murphy. And when the systems were flushed, were all the 
systems flushed thoroughly?
    Dr. Hicks. Uh-huh.
    Mr. Murphy. Every faucet, every showerhead?
    Dr. Hicks. Right.
    Mr. Murphy. Every one was tested?
    Dr. Hicks. Yes. Well, not every single one was tested, but 
many of them were tested.
    Mr. Murphy. What does that mean?
    Dr. Hicks. So when we went in, we had to collect a 
representative sample----
    Mr. Murphy. But I also heard someone say that, you know, 
you could have some dead-end pipes and things which could still 
be remaining in there.
    Dr. Hicks. Correct.
    Mr. Murphy. And so a representative sample?
    Dr. Hicks. Right.
    Mr. Murphy. At least five people died. One other thing I 
wanted to point out here, when people are saying that there was 
some testing done, what I have here is some information that 
says that is not true.
    Some testing was done on urine antigen levels, but 
Legionella cultures were not done on several people. We do not 
have names. But patients number one, two, four, six, seven, 11, 
12, 13, 19, 21, 22, 23, 25, 26, and 28, there was no Legionella 
cultures done.
    Why was that?
    Dr. Jesse. So these are individual patients. I cannot 
answer the specifics of why as for each. But I would say as a 
generalization it is often difficult to get sputum and the 
cultures have to come from sputum from those patients. Often 
when you get a urinary antigen test, and the patients may 
already have been put on antibiotics which would suppress the 
growth in----
    Mr. Murphy. And if we had----
    Dr. Jesse. I cannot answer----
    Mr. Murphy. If we had the information, though, could we 
also compare the sources of that if we looked back on some of 
the things from the old lab, the pathogen labs that would have 
had some of that old data in terms of sources?
    Dr. Hicks. So I just want you to know that we were able to 
compare what we had from the patients to what we found in the 
environment. And we had isolates from both patients.
    Mr. Murphy. But you did not have the old data from the old 
lab. I understand that was destroyed.
    Dr. Hicks. We had some isolates from the old----
    Mr. Murphy. But the old lab----
    Dr. Hicks.--from the 1980s.
    Mr. Murphy.--all that old was--a lot of that was destroyed, 
though, right?
    Dr. Hicks. I do not know, but I know that we had three 
isolates from the 1980s for testing.
    Mr. Murphy. Mr. Chairman, I hope that someone could answer 
this question because it is critical because I understand a lot 
of that data had been destroyed. And I understand my time is 
up, but I hope you or someone else will follow-up and ask that 
question why was all of that data destroyed and who ordered 
that.
    Thank you, Mr. Chairman.
    Mr. Coffman. Thank you, Mr. Murphy.
    Dr. Benishek.
    Mr. Benishek. Thank you, Mr. Chairman.
    Were all of you at the VA in Pennsylvania? Doctor, have you 
ever been there, Dr. Hicks? Dr. Jesse----
    Dr. Jesse. I have been there. I have not----
    Mr. Benishek. Have you been there since this happened and 
interviewed people?
    Dr. Jesse. No. Dr. Roselle.
    Mr. Benishek. Mr. Moreland, have you been to the----
    Mr. Moreland. Yes, I have.
    Mr. Benishek. You were there since this happened and 
interviewed people?
    Mr. Moreland. I have been there and I have talked to 
numerous people involved in the process, yes.
    Mr. Benishek. Well, you know, that is one of the questions 
that I am concerned about whenever we have this sort of hearing 
is that we just do not get to talk to the people that are 
directly involved. And that is very frustrating to me because 
it seems to be filtered through people like you.
    And I do not understand why we can't get to talk to the 
people that are actually involved to try to get a better 
answer. It always comes through, you know, congressional 
liaison people.
    So is there a better answer? Can anyone tell me why that 
some of the people from the Pittsburgh VA are not here 
specifically? Dr. Jesse?
    Dr. Jesse. Well, it was our feeling that this is a broad 
issue, that Mr. Moreland could, you know, represent the events 
that occurred at the VA.
    Dr. Roselle had a team that went in and did a thorough 
investigation, spoke to everybody there, not everybody, but the 
appropriate----
    Mr. Benishek. I know, but only Mr. Moreland has actually 
spoken to people at that VA. None of you----
    Dr. Jesse. No. Dr. Roselle has. Dr. Roselle took a team in 
of infectious disease----
    Mr. Benishek. Dr. Roselle, you were there? I did not get 
that.
    Dr. Roselle. Yes.
    Mr. Benishek. So who exactly did you talk to, Mr. Moreland, 
at that VA?
    Mr. Moreland. I have talked to the hospital director, the 
chief medical officer, the chief of infectious disease, the 
chief of engineering, the water maintenance supervisors, and 
other people as well.
    Mr. Benishek. So there is not a really good answer to the 
question as why we could not hear those people ourselves? No, I 
guess not.
    Let me ask another question about this 30 percent. This is 
30 percent of the samples that are taken, that is the threshold 
where something has to be done? So are these the same places 
that are being sampled every time? I mean, is it the same place 
that is positive consistently and there is only 20 percent of 
the places that are positive? I mean, is that what happens? I 
mean, are you aware if the 20 percent that is positive are the 
same sampling sites?
    Mr. Moreland. They do a random sample across the entire 
system and if there is a positive, they do a heat and flush and 
then retest to make sure that it is a negative. And then they 
rotate around.
    Mr. Benishek. Are they aware then which sample site is 
positive?
    Mr. Moreland. Absolutely.
    Mr. Benishek. And was it the same sample sites that were 
repeatedly positive?
    Mr. Moreland. I have not looked at that closely.
    Mr. Benishek. That would be sort of like an important 
thing, wouldn't it? I mean, if the same site is consistently 
positive, that 20 percent, that does not really mean anything 
then because----
    Mr. Moreland. They tested----
    Mr. Benishek.--it is the same site that is positive all the 
time.
    Mr. Moreland. They tested the site. Then they heat and 
flushed and they retested to make sure it was negative. And 
then they went around and picked other sites.
    Mr. Benishek. Can you explain to me a little bit further 
about why there is a discrepancy between the CDC and the no 
tolerance and this 30 percent? Who made that decision?
    Dr. Roselle. When that policy was written, because the 
science is not very good, I brought together a consensus group 
of experts including people from Pittsburgh and others----
    Mr. Benishek. Who made that decision; do you know?
    Dr. Roselle. When we wrote it, it was a group decision. We 
wrote the directive. And then it goes through a standard 
concurrence process.
    Mr. Benishek. So that was your decision then or is there a 
panel?
    Dr. Roselle. I do not make decisions alone. It was a 
consensus group in the VA.
    Mr. Benishek. What group is that? What is the name of that 
group?
    Dr. Roselle. It was a group formed just for this purpose.
    Mr. Benishek. So do you ever talk to the CDC about this 
because obviously their standard is different than yours?
    Dr. Roselle. Yes and no. The CDC, yes, we have talked to 
the CDC multiple times over the years. Remember the CDC does 
not even make a firm recommendation that water should be tested 
at all. For transplant centers, it says periodic testing can be 
done. For non-transplant centers, it is an unresolved issue. So 
when we----
    Mr. Benishek. Well, I guess I do not understand. When she 
is telling us that there is no percentage of Legionella is 
acceptable and then you are saying that up to, you know, 30 
percent of the samples can be positive, so I cannot understand 
the difference between that.
    Dr. Roselle. The difference between that is there has been 
and still is differences of opinion on action levels, water 
culturing at all, and Legionella remediation. The science is 
imprecise. So we end up making decisions that are reasonable. 
And, again, Allegheny County has made the same decision. So I--
--
    Mr. Benishek. Do you think that this decision is reasonable 
at this time?
    Dr. Roselle. The group is going to reconvene. In fact, it 
was supposed to convene today--it has been postponed--to start 
looking at this again going back to the science, talk to the 
CDC----
    Mr. Benishek. But you think it is unreasonable? Today you 
would say it was unreasonable?
    Dr. Roselle. Pardon me?
    Mr. Benishek. Today you would say that was an unreasonable 
decision that you guys made----
    Dr. Roselle. We are going to look at that.
    Mr. Benishek.--in retrospect?
    Dr. Roselle. We are going to look at----
    Mr. Benishek. All right.
    Dr. Roselle. We try to go in retrospect.
    Mr. Benishek. My time is up.
    Mr. Coffman. Thank you, Dr. Benishek.
    Mr. Rothfus.
    Mr. Rothfus. Thank you, Mr. Chairman.
    My apologies for not being here for the earlier testimony. 
We have multiple hearings going on.
    Just a couple quick questions. As I understand it, there 
was an issue spotted back in November of 2011; is that correct?
    Dr. Jesse. In 2011, there was one hospital acquired and 
then a group of other diagnosed cases of Legionella.
    Mr. Rothfus. But did testing reveal that there was 
Legionella in the system at the time in November of 2011?
    Dr. Jesse. Yes, it did. And there were actually three 
rounds of remediation that occurred at that time.
    Mr. Rothfus. And did that, in fact----
    Dr. Jesse. And the final was where a single sample of 27 
was positive and they did another heat remediation.
    Mr. Rothfus. And that was over a period of how many months 
from November 2011?
    Dr. Jesse. Well, that was September, October, November when 
the cases were identified. There actually was a remediation in 
August and November and December and in January. From December 
through April of 2012, there were no cases.
    Mr. Rothfus. And so between January 2012 then and November 
2012, there were not----
    Dr. Jesse. No. Actually, through April of 2012, there were 
no cases. There were three cases of Legionella diagnosed at the 
facility, one in May, two in June. None in July. And then in 
August, this seemed to come out where two were hospital 
acquired.
    This is where the epidemiologists, infectious disease folk 
at the hospital became concerned because they needed to link 
them back. In fact, one of those patients was never 
hospitalized, had only been there, I believe, on two occasions 
for outpatient visits.
    But involving the CDC through local and county health 
authorities and doing genotyping which takes time because you 
have to culture and grow the Legionella and then do the 
genotyping. So those results came back to the VA on October 
31st.
    November 2nd I think the letter from the director went out 
through the county and state authorities to request inter-
session of the CDC. That team was on-site on the 7th, was there 
through the 16th.
    Mr. Rothfus. Following the remediation that followed the 
2011 finding, what would the standard procedure have been for 
testing again?
    Dr. Jesse. Well, again, the standard is one that is set by 
the local system. I think the minimum mandate would have been 
twice a year because they have a transplant center. The 
practice was they actually did it more like six to ten times 
per year. And, in fact, testing was done in March and April and 
in June.
    Mr. Rothfus. And the results of those tests?
    Dr. Jesse. I shall put my glasses on and tell you. Zero in 
March, zero in April, five of 26 in June. Remediation followed 
that.
    Mr. Rothfus. Okay. Thank you.
    Thank you, Mr. Chairman.
    Mr. Coffman. Thank you, Mr. Rothfus. All right. We are 
going to begin a second round of questions with the same panel. 
Dr. Jesse, was the outbreak of Legionnaires' Disease in 
Pittsburgh preventable?
    Dr. Jesse. So I am going to answer that cautiously.
    Mr. Coffman. Just answer it please. Thank you.
    Dr. Jesse. It would be preventable by maintaining a water 
temperature at the tap of 130 degrees. There is a risk in the 
risk of scalding of patients, and that is an unacceptable 
risk----
    Mr. Coffman. Versus a patient dying?
    Dr. Jesse. Patients die from scalds. So what we are dealing 
with is an area between a water temperature between about 110 
and 130 degrees, where one has to balance the risk of scalding 
patients----
    Mr. Coffman. Was it preventable?
    Dr. Jesse. Was it preventable? As I said if you put the 
water temperature high enough----
    Mr. Coffman. Can you just answer the question?
    Dr. Jesse. I have answered the question. If we had turned 
the water temperature----
    Mr. Coffman. You are saying that it is preventable?
    Okay. Please put up a slide.
    [Slide]
    Mr. Coffman. According to information provided to this 
Subcommittee by the VA as of December 17, 2012, can we get that 
up? Okay, you are bringing it up? There were only two 
Legionnella cases in 2012 and neither were hospital acquired. 
Okay, I will wait until that is up. Okay. In speaking to just 
one of the county health departments that VA would typically 
report Legionella cases to, VA reported seven Legionella cases 
in 2007, six in 2008, one in 2009, five in 2010, ten in 2011, 
and seven in 2012. These numbers do not necessarily represent 
hospital acquired Legionella. But CDC's investigation that 
covers only two years shows 14 Legionella cases definitely or 
probably acquired at the VA facility in 2011, and 17 Legionella 
cases definitely or probably acquired at the VA facility in 
2012. There is a glaring disparity between what VA accepts 
responsibility for and what CDC and others attribute to the VA. 
Would any of you care to comment on that?
    Dr. Jesse. Sure, let me make a couple of comments. I think 
you started off talking about two cases, and let me make very 
clear what that refers to. When we had seen the issues in 
Pittsburgh at a national level, we went to every VA facility 
and said, ``Do you have any cases of Legionella now?'' A point 
in time survey. There were five cases, two in Pittsburgh, I 
think one in New England, one in the Intermountain West, one in 
the South. That was a point in time survey. It was in no way 
intended to, it was point prevalence, not incidence.
    In terms of the number of cases being reported, be very 
cautious. Because CDC often reports county data. And so in 
Allegheny County in 2012 there were 50-plus or minus one or two 
because of late December, we are not sure, cases of Legionella. 
Five of those were VA patients. But that is only patients who 
were in the county. It is not from the hospital, it is county 
residents. So it is a different reporting structure.
    My understanding in looking at CDC, we fully agree with the 
number of cases reported by the CDC. We fully agree with the 
attribution of hospital acquired.
    Mr. Coffman. Mr. Moreland, why was the lab data destroyed 
in 2006?
    Mr. Moreland. When the Special Pathogens Lab was closed, 
there were multiple sets of data and specimens in the Lab. All 
lab specimens that were categorized, labeled, and had a catalog 
were moved intact to the other laboratory at the VA Pittsburgh. 
Those things still reside there. The only thing destroyed at 
the VA Pittsburgh, at Pittsburgh when the Special Pathogens Lab 
closed were uncategorized, unlabeled samples that did not have 
a catalog of what the samples were. So they were unknown 
samples left in the lab. That's the only thing that was 
destroyed. Because uncatalogued samples left in a laboratory 
are considered biohazards and need to be destroyed.
    Mr. Coffman. Ranking Member Kirkpatrick?
    Mrs. Kirkpatrick. Thank you, Mr. Chairman, and thank you 
panel. I have many questions about this and I will submit most 
of them in writing in the interest of time for this Committee. 
But in my briefing materials I want to take the conversation in 
a little bit different direction. There is a note that there 
was a sprinkler system interruption due to a water line break 
in November of 2012. And then I also want to reference for the 
record the CDC report of January 25th of this year. And here is 
what it says. ``Extensive construction at the hospital, the 
timing of construction work at the hospital coincides with the 
outbreak. Construction likely introduced organic matter to the 
potable water system, increasing consumption of chlorine in the 
municipal water supply leading to amplification of Legionella. 
Residual chlorine in the water system, although at adequate 
levels in the incoming municipal water supply, was at an 
insufficient concentration for microbicidal activity at all 
distill sites measured within the hospital.''
    That is extremely concerning to me. Dr. Hicks, could you 
talk with me about that? And I would like to know, what the 
circumstances were, but also what remedial efforts have been 
put into place?
    Dr. Hicks. Okay. So I think it is important to note that 
this hospital was not paying particular attention to the 
chlorine levels because they had a copper-silver ionization 
system in place. And the claim is that copper-silver ionization 
in and of itself is effective for disinfecting water. What we 
found here is that obviously during our investigation when we 
measured copper and silver levels, we found Legionnella in all 
of those samples despite adequate levels. So we were trying to 
hypothesize as to why this happened when it did. Because this 
copper-silver system has been in place for so many years.
    So we looked back and the construction work that had been 
done and the construction work actually was, it was right 
before this big increase in cases. And so we hypothesized that 
the construction introduced material into the water supply that 
consumed chlorine. And it may have been that quite a bit of 
chlorine was getting through to the distill parts of the 
building and lowering levels of Legionella prior to the 
construction work. And that may have kind of produced a 
synergistic effect with the copper-silver system.
    But once that chlorine was out of the picture, one there 
was no chlorine in the system to knock back Legionella levels, 
then Legionella just grew rampantly.
    Mrs. Kirkpatrick. Dr. Jesse, can you address in terms of a 
systemwide effort or policy to be more vigilant during times of 
construction? It looks like there is definitely a clear link.
    Dr. Jesse. Well it may not be so clear. There has been 
construction on that campus going back many, many years. I 
think the issue here is that this is indeed complex. What we 
are trying to answer is, why did a system that was apparently 
effective for many years all of a sudden start having problems? 
And despite having adequate levels of copper and silver ions in 
the system could still grow Legionella? And so as Dr. Hicks 
said, you have to start looking beyond the obvious, and what 
are other things that might have contributed? And the 
construction would be one. So----
    Mrs. Kirkpatrick. Excuse me for interrupting, but not to 
quibble with you but my reading material says that Legionella 
has been at this campus since 1981.
    Dr. Jesse. Legionella has been everywhere since, you know, 
time immemorial. So----
    Mrs. Kirkpatrick. Right. My question, and I understand 
systemwide, but my question is have you looked at construction, 
you say that happens all the time on the campus, to be more 
vigilant? And maybe Mr. Moreland----
    Dr. Jesse. Absolutely, I think we need to be. And as we are 
rewriting the national directives, I think this is something 
that has to come into play. It clearly is one of the things 
that explains the difference. But it is, at this point it is a 
hypothesis. But I think we need to take it seriously.
    Mrs. Kirkpatrick. Thank you, Mr. Chairman. I yield back.
    Mr. Coffman. Thank you, Ranking Member Kirkpatrick. Dr. 
Roe?
    Mr. Roe. Thank you. Thank you, Mr. Chairman. And I think we 
have to go back and say why is this a serious issue? And the 
reason it is a serious issue, as Dr. Hicks brought up, is that 
Legionella pneumonia carries a five to 15, some as high as a 30 
percent, mortality rate. That is higher than open heart 
surgery. So that is why it is a serious issue, because it has 
such a high mortality rate. And that is why we have to be 
vigilant and try to prevent this. Because we know, and these 
are either immunocompromised patients, or patients over 65, or 
patients with chronic lung disease, or any of the debilitating 
diseases that we get as we age. So that is why it is important.
    And the Chairman asked a minute ago, was this preventable? 
And I think you can say that yeah, the easy answer is a lot of 
things were tried but the answer is yes because it is prevented 
in a lot of other places. And there are I think 37 other 
systems that use a copper-silver system that has not had this 
problem. So it is clearly working somewhere. Something 
happened. And Dr. Jesse, you may be right. It could be the 
factor, the construction, or whatever that was another factor 
in there if the levels were normal. But some of the analytics 
that we have got here, and this is a very cumbersome book, I 
obviously did not read that all last night, that suggests that 
these levels were not adequate. Is that right?
    Dr. Jesse. So I do not know and I cannot speak to the 
necessity to constantly maintain these levels at all times. We 
do know that these systems require a lot of manipulation to 
keep them line. The testimony submitted from Pittsburgh 
Presbyterian describes a process very much like what VA was 
doing, measuring, readjusting, readjusting constantly. But we 
also know there has been another hospital in Pittsburgh that 
despite having good silver ion levels over a long period of 
time also was no longer handling the Legionella burden and put 
in place a monochloramine system. That was reported in an 
abstract.
    Mr. Roe. It says, these analytics right here say that for 
more than a year that the silver levels were not adequate.
    Dr. Jesse. I do not know if they were not adequate. There 
were probably points in that year when they were not on, I do 
not think that there was time----
    Mr. Roe. Yeah, these are yours. These are not, I mean, 
these are reports from the VA here. So we need to get that 
answer because we need to know that.
    Dr. Jesse. But we----
    Mr. Roe. And obviously those patients in that hospital and 
their families need to know that. I think that is, we will get 
a written after this is over. We will put that in writing for 
you. And Dr. Hicks, have you seen this? I know you do not just 
look at VA's, you look at hospitals across the country.
    Dr. Hicks. Mm-hmm.
    Mr. Roe. Have you seen this? I have been in a medical 
center with 600 beds, and a VA hospital right next door to it 
that is a large VA, and I have not seen this problem at either 
one of those facilities in over 30 years I have been in Johnson 
City, Tennessee. Have you seen this in other hospitals where 
outbreaks? And again, when you are seeing thousands of 
patients, I realize that it is hard to identify two which would 
be an outbreak.
    Dr. Hicks. Mm-hmm.
    Mr. Roe. I have got that. I understand that. Have you seen 
that?
    Dr. Hicks. Yes, I would say that it is a very unfortunate 
occurrence. But health care associated Legionnaires' Disease is 
quite common. And in the U.S. we believe there are somewhere 
between 8,000 and 18,000 cases of hospitalized Legionnaires' 
Disease every year and a good portion of those are health care 
associated. So this is not an uncommon occurrence in hospitals. 
And I would say that I suspect, and this may, this will be very 
disturbing to many of you, I suspect that many of these 
outbreaks go undetected. I think this is a situation where this 
outbreak was detected because they have a very aggressive 
testing policy, both for testing patients----
    Mr. Roe. I would think though that, I mean we are pretty, 
when you look at an x-ray, and you have many times and I have 
too, of pneumonia, you are going to pretty aggressively try to 
diagnose because you have to know what antibiotic to treat it 
with.
    Dr. Hicks. Sure. Yes.
    Mr. Roe. Not just a, ``Here is a pneumonia and let me just 
take a shotgun and fire it at the x-ray.''
    Dr. Hicks. Mm-hmm.
    Mr. Roe. You want to know exactly what bug it is because 
you can lose that patient by not doing that, and certainly in 
patients that are debilitated to begin with.
    Dr. Hicks. Yes.
    Mr. Roe. Who typically get pneumonia. So I think we need 
some answers to this right here. It is important because this 
seems to be an outlier.
    Dr. Hicks. Right.
    Mr. Roe. As opposed to what happened. And I think the 
reason it would give me some comfort is if those levels were 
normal then maybe those standards need to be changed. And I 
think the other thing, I was a little, I did not know how 30 
percent, you know, a lot of times things are arbitrary. How 
many liters of fluid went on the space shuttle? Somebody said 
four, and that's how many there are. So this 30 percent, was 
there any basic science in that that said, ``This was a 
threshold,'' or any studies that document----
    Dr. Jesse. Yeah, there has been a study that talks about 
this and documents it. But I will reiterate what I said before. 
The science for almost everything we have talked about today is 
weak. Most recommendations are not strong for any of these 
because the science just is not there. So, which is again why 
we are going to, we are reviewing the literature again. And I 
am sure that new guidelines coming from the CDC will have also 
reviewed all of the literature----
    Mr. Roe. Just one more question for you all and Dr. Hicks, 
is the CDC's recommendation zero tolerance?
    Dr. Hicks. Yes, that is correct.
    Mr. Roe. Okay, that is the standard. That would be easy. I 
could make that vote this afternoon. I yield back.
    Mr. Coffman. Thank you, Dr. Roe. Mr. Walz?
    Mr. Walz. Thank you. I'm going to kind of piggyback onto 
what Dr. Roe said. I think that is really the bigger issue 
here. This is a much broader issue. Dr. Jesse, I appreciate 
your point on that.
    Obviously, we come back again to this issue of zero sum. I 
do not know if there has ever been a congressional hearing on 
private sector hospitals and their infection rates, but we 
heard on this. We are going to hear from some experts next that 
I think is going to help clarify some of this and go through 
it.
    But can someone tell me is it kind of just personal choice? 
Or is it cost involved? Why chlorine dioxide over copper-silver 
ionization? The research I looked at, and some of the people 
who wrote the research are sitting behind you, seems to 
indicate it is up in the air. Is there a reason? And what do 
the other local hospitals, you just mentioned it a little bit, 
Dr. Hicks, they used the chlorine, or excuse me, the copper-
silver ionization.
    Dr. Hicks. So I think it is a really important question 
because there really is no one size fits all solution to 
controlling this problem. And it is a very difficult problem to 
solve. And as someone mentioned recently that it is like trying 
to get rid of house flies. But obviously a much more dangerous 
type of situation here.
    Mr. Walz. Yes. Okay.
    Dr. Hicks. So it obviously needs to be taken very 
seriously. But there are, there are different disinfection 
methods to try to address it in the environment. The two that 
are currently EPA approved are chlorine and chlorine dioxide. 
And so those are the two EPA approved methods for disinfection 
of water systems. And it would be nice, ideally, if we can 
build the capacity within our program and work with EPA, we 
would really like to take the opportunity to evaluate all of 
these different approaches to Legionellosis prevention and do 
head to head studies.
    Mr. Walz. Because I am interested. And from a CDC 
perspective, I understand. And it is, we all want to reach 
zero. We want to do this. But there are considerations based on 
cost, what you have the capacity to put in place and things 
like that.
    Dr. Hicks. Right.
    Mr. Walz. And I would get back at this issue of 
preventability. I mean, I think it is important. But this is a 
tough one with medicine. And maybe it is because of the 
successes that we have had that folks want to see that and we 
should strive for zero on this. But from a preventability case. 
The only way to prevent that they would have gotten this there 
is for them not to enter the facility. The same way to prevent 
automobile accidents, if no one drives. That is the only 
certain way you can do that. But the cost of not doing that, 
the cost of a veteran not going to the Pittsburgh hospital with 
chronic chest pains because of this, I think we have to be very 
careful. On we want to strive for a zero preventability. But I 
think there is always a squeezing of the balloon, if you will, 
that something happens somewhere else. And the same thing on 
are we putting our money in the right place? Are we testing 
accordingly? Are we mitigating circumstances where they should 
be?
    Because I think, and I was just mentioning this, I would 
have to think if there were any test at all that showed 
anything at the Minneapolis VA, all kinds of red flags would go 
up. Because if I am understanding it right, that is very 
unusual, that I do not think they would get a test. Am I right 
on this, where we are going?
    Dr. Jesse. So as I said, there are some VAs whose municipal 
water is treated with monochloramine that do not have a 
problem. It is almost pointless for them to test. And if they 
did, and something popped up, it would really raise a red flag. 
There are certain parts of the country, likewise, never had a 
case, never tested positive in the water. So to continue 
testing would not make sense.
    But again, the management of Legionella is not a single 
thing. It is surveillance of both the clinical cases, and this 
is the only thing I know of where we also monitor environmental 
cases. You know, we monitor pertussis, we monitor TB from the 
clinical incidents. But in this case, we are also monitoring 
the environment. And we do that most rigorously in cases, in 
areas, in hospitals where we have historically had a problem or 
we have ever identified cases. And the strategy then is built 
on, you know, the individual hospital and their history.
    Mr. Walz. Dr. Hicks, would you happen to know if CDC's 
budget is cut under sequestration or not?
    Dr. Hicks. I do not know anything about the budget----
    Mr. Walz. I am just curious, as we as a Nation have these 
conversations, I am guessing and I am seeing this, this 
monitoring and this remediation is a very expensive process. Am 
I right to say that?
    Dr. Hicks. Yes.
    Mr. Walz. Now my question is, is that it is worth it, 
because I agree that no veteran should go there, or no patient 
should go to a U.S. hospital. But I think this broader issue, 
and if there are specific issues of, that we missed at a high 
chance hospital, or high rate hospital, we should work with 
that. But I think this gives us an opportunity, Mr. Chairman, 
to take this to a broader level about what is CDC's role, what 
are those standards. Because I am baffled, too, by the 30 
percent thing. And I understand that at some point you have to 
set a number. But I kind of agree with Dr. Roe, that if it is 
causing it, that is where it should be.
    But I yield back. Thank you, Mr. Chairman.
    Mr. Coffman. Thank you, Mr. Walz. Dr. Benishek? Mr. 
Rothfus?
    Mr. Rothfus. A question on the copper-silver ionization. Do 
you have confidence today that that process, is it still being 
used at the VA in Pittsburgh?
    Dr. Jesse. VA Pittsburgh took the copper-silver offline. 
Again the major sway point was that at the time the CDC looked 
at their samples, the copper and silver ion levels were within 
range and they could still grow Legionella. And again, this was 
a system that had worked for many years of suppressing 
Legionella. It does not eradicate it completely, but it 
suppresses it. And clearly at this point in time something 
different, something had changed. So now it is offline and they 
are using what is called a chlorine drop to increase the 
chlorine level running to the tap heads to control that.
    And again, that is pending the, a more long-term and 
permanent solution, as Mr. Moreland mentioned, that is going to 
include putting a scald free taps in place for all the taps and 
showers. And that allows us to raise the water temperature up, 
which also mitigates growth. And a more permanent solution, 
whether it is monochloramine, whether it is chlorine dioxide, 
we do not know. We have to look into that. We will make that 
decision based on the best advice of both internal and external 
experts and advisors.
    Mr. Rothfus. How recently was the chlorine drip initiated?
    Dr. Jesse. It was initiated in November? Yeah.
    Mr. Rothfus. Have we done testing since that time?
    Dr. Jesse. So they did, the CDC recommendation was, they 
did the heat remediation, they followed that with a 
hyperchlorination. So that is like chlorine to pool level. You 
cannot drink it. And now a chlorine drip that maintains a lower 
but, you know, drinkable level of chlorine in that system.
    Mr. Rothfus. When was the last time we tested for the 
presence of Legionella?
    Dr. Jesse. We've been testing, they have been testing every 
two weeks and the system has been clear. The plan is to 
continue that testing for at least 90 days. And then in 
consultation with CDC, we will change whatever that testing 
strategy might be.
    Mr. Rothfus. Thank you. Thank you for that.
    Mr. Coffman. Thank you so much, panel. And I just want to 
note again for the record that the individuals that were 
requested to be here and testify, that were directly involved 
in this particular incident, are not here today. Oh, Mr. 
Murphy? Okay. Let us bring the next panel. I now invite the 
second panel to the witness table.
    On our second panel, we will hear from Dr. Victor Yu, 
Professor of Medicine at the University of Pittsburgh; Dr. 
Janet Stout, Director of the Special Pathogens Laboratory; Mr. 
Aaron Marshal, Operations Manager for Enrich Products, Inc.; 
Mr. Steve Schira, Chairman and Chief Executive Officer of 
Liquitech, Inc.; and Ms. Kathleen Dahl, President of AFGE, 
Local 228 at the Pittsburgh Veterans Affairs Medical Center. 
All of your complete written statements will be made part of 
the hearing record. Dr. Yu, you are now recognized for five 
minutes.

    STATEMENTS OF DR. VICTOR L. YU, PROFESSOR OF MEDICINE, 
  UNIVERSITY OF PITTSBURGH; DR. JANET STOUT, DIRECTOR SPECIAL 
 PATHOGENS LABORATORY; MR. AARON MARSHALL, OPERATIONS MANAGER, 
  ENRICH PRODUCTS, INC.; MR. STEVE SCHIRA, CHAIRMAN AND CHIEF 
  EXECUTIVE OFFICER, LIQUITECH, INC.; AND MS. KATHLEEN DAHL, 
PRESIDENT, AFGE LOCAL 2028, PITTSBURGH VETERANS AFFAIRS MEDICAL 
                             CENTER

                   STATEMENT OF DR. VICTOR YU

    Dr. Yu. Mr. Chairman, I was Chief of Infectious Disease at 
the VA Medical Center for almost 30 years and received superior 
performance evaluations for each of those 30 years. And I also 
want to say that the Pittsburgh VA is a great medical center. 
Healthcare givers and the services there are extraordinary.
    However, the upper layer of bureaucrats causes, and this I 
think is true for many hospitals, the bureaucrats cause us some 
problem. But as I was listening to today, where you say, ``Hey, 
it is not 30 percent so you do not have to do anything.'' They 
had 16 cases with five deaths. And maybe if there is a patient 
who dies of Legionnaires' Disease, maybe you should pay 
attention to that one and not whether or not it is 30 percent. 
So that is just a parenthetical statement.
    I was also Chief of the Special Pathogens Lab. And the 
Special Pathogens was established under the aegis of VA's 
central office in the early 1980's because of the massive 
number of outbreaks. Not only the American Legion outbreak, but 
outbreaks at Wadsworth VA Medical Center, 200 cases, four 
years; VA Medical Center, 100 cases, three years; Togus VA 
Medical Center, 50 cases, possibly in one to two years. And 
based on that, our lab was designated as a special reference 
lab. And then it was formalized under the previous director, 
before Mr. Moreland came, as a special clinical resource center 
for the VA. And one of the things that we were supposed to do 
was because of the prominence of our lab, we were doing not 
only cultures for the entire VA Medical Center, but for all 
academic medical centers in the United States, and in public 
health agencies that would send specimens just because we were 
the only lab that was doing that. And therefore the VA thought, 
``We can charge money for it.'' And three special clinical 
resource centers were set up. Yale, for virology; Florida, for 
fungi, but the most famous one of them all became the 
Pittsburgh VA Special Pathogens Clinical Resource Center. And 
we did the cultures for the entire VA.
    Now our accomplishments I think are a matter of record. And 
we received many honors, not only from NIH, but most of them 
have come from the VA, from international societies. And the 
one that I treasure the most is from the American Legion. Here 
are a few of the key things that were done.
    Janet Stout discovered the source of Legionella in the 
hospitals was not in the cooling towers. It came right from the 
drinking water of the hospital, published in the New England 
Journal of Medicine in 1982. But 1976 was when the outbreak was 
occurring. So these outbreaks are occurring all over the world, 
actually, at this time. And they started to look for cooling 
towers and it was right in the drinking water.
    But that discovery also meant another thing. If we know 
where it is, and it is right in the hospital, we can prevent it 
by going after it in the hospital. And this is a sore point 
between we and CDC because we endorsed the drinking water 
concept and CDC endorsed the cooling tower concept. And it now 
turns out that we have a pretty good record now. And so now we 
are able to prevent it. And so we and the University of 
Pittsburgh Department of Engineering instituted a systemic 
process where we would try innovative ideas, trying to figure 
out how could we get this organism out of the water 
distribution system? Dr. Hicks was so shocked that this was, 
this organism was in there since 1982. And she is relatively 
new to Legionella. Every hospital, this is be it Barcelona, 
Spain, or Palo Alta VA, or all of the VAs, that organism stays 
in the hospital for the rest of the lifetime of the hospital. 
And Columbia Presbyterian wondered maybe they should tear out 
all their pipes? They did that accidentally by using 
chlorination and then would later switch over to copper-silver.
    So the organism, it gets into the biofilm, which is a thick 
film and detritus, the calcium deposit, and it stays there. And 
so you can suppress it pretty easily. But if you do not 
maintain the system, that organism will come out. And so every 
hospital, be it Barcelona, Spain, the United Kingdom, when it 
comes out it is the same organism by genotyping that was there 
30 to 40 years ago. That is an actual fact that almost all 
Legionella experts know about.
    Now this is what we and the Department of Engineering did. 
And these were engineers that were graduate students and 
professionals in engineering. We were the first to evaluate all 
of these innovative technologies. The first one we tried was 
super heat and flush. There are some problems with that because 
it is tedious. The second one we tried was chlorination. And so 
many, many hospitals institute chlorination and we did the 
first controlled study published in the Lancet in 1985. So we 
know chlorination. And there are some problems with 
chlorination. But by the early 1990's, we decided to try 
another modality called copper-silver. That modality is now, 
and you have a list, all the great medical centers in the 
United States, almost all of them have copper-silver today. And 
that can be discussed later.
    We were the first to introduce chlorine dioxide in the 
United States. The second, but the first one to evaluate it in 
the controlled studies. The chlorine dioxide had failed in the 
United Kingdom. But we found out that it could work if you did 
some certain things and that will come out.
    Monochloramine, which Dr. Jesse mentioned. We are the first 
in the United States to institute monochloramine. That is our 
study and it is undergoing evaluation.
    Now we also developed all of the microbiology methods. You 
do not need to use a liter, or 100 liters. And I will not go 
into that. Every one of the culture media used for isolation 
from patients or from the drinking water, we developed that 
media. That media is commercialized. We gave out no patent. So 
all of the culture media that all of the hospitals use in the 
United States today, almost all of them are based on----
    Mr. Coffman. All right. I think, I am sorry, but we are 
running out of time. I wonder if you could just conclude with 
your testimony? And we will get to the rest of the panel and 
then we will get to questions, and you will certainly have an 
opportunity to amplify things in questions.
    Dr. Yu. Okay. Well the most important that we did, we came 
up with the antibiotic that resulted in over a 95 percent cure. 
And we tested all the antibiotics for the pharmaceutical 
industry. And based on that, we recommended that certain 
antibiotics come out two one. One is called Azithromycin, which 
is the Z-pack. What is used in the hospital is a more powerful 
IV form. Then the second one that we came out was Levaquin, or 
Levofloxacin. And that one led to almost no mortality.
    So that is the one point that we want to make. You can not 
only prevent it from occurring in the hospital. If it occurs, 
you can save their life by giving them the antibiotics. And so 
from 1996 to, 21 consecutive years where there was not a single 
case of Legionella. But if there was, they would have lived.
    And Arlen Specter and the American Legion, because when 
they closed the Special Pathogens Lab, they warned the VA that 
maybe this is not a good idea for the patient. And Brad Miller, 
Congressman Brad Miller in the 2008 hearings, made this 
prophetic statement. He said, ``Dr. Yu, we will never know how 
many patients died because of what the VA did.'' But it turned 
out Congressman Miller was wrong. We did know. There were five 
at the Pittsburgh VA Medical Center. Preventable disease by 
prevention, and preventable with antibiotics.

    [The prepared statement of Dr. Victor Yu appears in the 
Appendix]

    Mr. Coffman. We will come back to you with questions. Dr. 
Stout, you are now recognized for five minutes.
    Dr. Yu. It says only four minutes on my clock, sir. 4:50. I 
only have one sentence to make, if I could just make it? 
Because I do have ten seconds on my clock. Oh, okay.

                    STATEMENT OF JANET STOUT

    Ms. Stout. Okay. I want to thank the House Veterans' 
Affairs Subcommittee on Oversight and Investigation for holding 
the hearing; Senator Casey, Congressmen Doyle and Murphy for 
requesting investigations into the Legionnaires' Disease 
outbreak that occurred at the VISN 4 health care facility in 
Pittsburgh. The affected veterans and their families deserve 
full disclosure from the administrators at the University Drive 
and Heinz facilities in Pittsburgh.
    I am a microbiologist trained in environmental and clinical 
microbiology, and hold a masters and Ph.D. degree from the 
University of Pittsburgh Graduate School of Public Health. I am 
testifying today as a subject matter expert on Legionnaires' 
Disease. My 30 years of research in the field of Legionnaires' 
Disease provides me with special knowledge about Legionella 
bacteria, the methods to control it in hospital water systems, 
and the methods to investigate possible cases of hospital 
acquired Legionnaires' Disease. I also have intimate knowledge 
of the procedures and practices that were established at the 
Pittsburgh VA facilities in response to previous outbreaks at 
those facilities. And this includes methods and scheduling for 
monitoring or testing Legionella and the copper and silver 
ions, maintenance of the ionization system, and the 
microbiological methods for detecting Legionnaires' Disease 
both in patients and the environment.
    The approach to prevention of Legionnaires' Disease 
developed at the Pittsburgh VA stopped an epidemic and resulted 
in groundbreaking discoveries in case detection and water 
system disinfection. These procedures were followed by other 
facilities to prevent the disease, including guidelines in 
Pennsylvania, Maryland, New York, and the Veterans Healthcare 
System. Through our efforts, Legionnaires' Disease was 
controlled at the Pittsburgh VA. In fact, as we heard earlier, 
there were no cases of hospital acquired Legionnaires' Disease 
for over ten years.
    So the question is, how did this happen? You will hear 
excused and diversions trying to shift responsibility to 
methodology, policies, public health authorities, and even 
blaming the disinfection technology that protected the VA 
patients from 1994 to 2006. Do not be distracted.
    The failures to be investigated include, one, failure of 
the Pittsburgh VA to recognize they had an outbreak and take 
preventative actions. The delay may have contributed to 
additional cases and deaths. Two, failure of the VA lab to 
detect Legionella in the water at the VA University Drive. This 
has likely contributed to delay in detecting the outbreak. And 
this failure was due to lack of knowledge and experience, a 
problem that was brought to the VA Inspector General's 
attention in 2009. Three, failure of the VA to operate and 
manage the copper-silver ionization disinfection system. And 
finally, failure to communicate with physicians, staff, 
patients, and families regarding the increase in cases. The 
delay in alerting physicians may have contributed to additional 
morbidity and mortality.
    The only way an outbreak of this magnitude could have 
occurred is if the water system at the Pittsburgh VA had become 
heavily contaminated with Legionella. The environmental testing 
performed by the VA microbiology laboratory should have 
detected this increase.
    At the time of the 2012 outbreak reports from the 
ionization manufacturers indicated that the copper-silver 
system monitoring, when performed, did not meet the suggested 
target levels and that documentation of this condition began as 
early as the spring of 2012. We really need to know what were 
those results of testing for copper-silver in 2011 and 2012?
    Based on my experience, and after review of the CDC report, 
I offer the following comments and recommendations. The 
Pittsburgh VA microbiology laboratory failed to detect 
Legionella in environmental samples due to inexperience, lack 
of knowledge, and use of outdated methods. A problem that, as I 
said, was brought to the attention of the Inspector General in 
2009. However, they continue to perform testing for other VA 
facilities. The Pittsburgh VA microbiology laboratory should 
discontinue this process of offering testing to other VAs and 
they should notify those facilities that the results of that 
testing may be inaccurate.
    The CDC is invited to assist with facilities in dealing 
with outbreaks. As their guest, their recommendations will not 
assign responsibility, but will merely suggest changes in 
policy, which we have heard today. It will be the role of this 
Committee to hold people and the administration accountable for 
the failures that led to this outbreak. And accountability 
needs to come from the top down, not the bottom up.
    The VA Legionella directive and public health policies 
should not be rewritten due to the management failures of this 
facility. It was the responsibility of the Pittsburgh VA to be 
current in knowledge and vigilant in following the policies and 
procedures that were already in place. The system is not 
broken, so do not fix it.
    Finally the VA management does owe an apology to the 
physicians, staff, patients, and families regarding the delay 
in informing them that there was an increase in cases and that 
an outbreak of Legionnaires' Disease was suspected.
    Thank you for your attention. I am happy to answer any of 
your questions.

    [The prepared statement of Dr. Janet Stout appears in the 
Appendix]

    Mr. Coffman. Thank you, Dr. Stout. Mr. Marshall, you are 
now recognized for five minutes.

                  STATEMENT OF AARON MARSHALL

    Mr. Marshall. Mr. Chairman, Committee Members, thank you 
for inviting me to testify today. My name is Aaron Marshall and 
I am the operations manager for Enrich Products. Enrich 
supplies copper-silver ionization systems for the control of 
Legionella in potable water systems. I am also a veteran of the 
U.S. Army, having served honorably for over four years. And my 
father was also a veteran who received exception medical care 
from the VA Health System for many years and currently receives 
that same exception care in West Virginia VA Health System.
    The intent of my testimony is to provide information that 
will contribute to a better understanding of what transpired at 
the VA University Drive Campus in Pittsburgh, and to provide 
supporting evidence that copper-silver ionization, when applied 
properly, is an effective method for controlling Legionella in 
potable water systems.
    There are two ways copper-silver ionization systems can be 
implemented. The first is a proactive course, and the second is 
a reactive course. In a proactive course a copper-silver 
ionization system is installed as a preventative measure. In 
these facilities, there is no confirmed cases of Legionnaires' 
Disease or Legionellosis. The facility may not even test for 
Legionella. In a reactive course, a facility has either 
confirmed the presence of Legionella in the water through 
testing, or the facility's potable water system is suspected or 
implicated as the source of Legionnaires' Disease or 
Legionellosis cases. In response, a copper-silver ionization 
system is installed temporarily or permanently. Once the 
desired results are achieved through the reactive course, the 
equipment is either removed or continues to operate in the 
course as transition to the proactive regimen.
    The difference between the two rests in the courses of 
action recommended, and they are quite significant. In the 
proactive course, lab monitoring for copper and silver ions is 
recommended monthly. Flushing of non-used fixtures is 
recommended monthly also, and Legionella testing may or may not 
happen.
    In the reactive course, lab monitoring for copper and 
silver ions is performed weekly. The facility institutes a 
controlled flushing program such that all fixtures are flushed 
weekly and Legionella testing at day 15 and day 30 is conducted 
to determine the course's effectiveness. This reactive course 
has been successfully implemented at numerous facilities, 
including the Cleveland VA Medical Center, as well as 
facilities in Pennsylvania, Florida, New York State, North 
Carolina, and Illinois.
    I am here today because in June of 2012, at the request of 
the Pittsburgh VA, I personally was called in to perform a 
review of the copper-silver ionization system and its operation 
at their facility located on University Drive in the Pittsburgh 
neighborhood of Oakland. I was asked to make recommendations 
that would help to improve the functioning of their existing 
equipment, their existing equipment provided by Liquitech. And 
they are just another supplier of copper-silver ionization 
equipment.
    Before submitting my general recommendation report on July 
6, 2012, I visited the VA University Drive campus facility 
three times. The dates were June 4, June 24, and July 2. There 
was no charge to the VA for these visits, or for my report. 
During my visits, I personally viewed the four different 
locations where the Liquitech copper-silver systems were 
installed. I was provided access to the site records from 
January, 2012 until the end of June, 2012, and the lab copper-
silver data from June, 2011 through July, 2012. I requested but 
was denied access to view the Legionella test results.
    During two of the three visits, I had separate visits with 
infection control and engineering and maintenance personnel. 
The two meetings covered similar topics. Those major topics 
were system maintenance, frequency for monitoring of copper and 
silver ion levels, and criteria to determine site tests and lab 
testing locations. In each of the two meetings I covered the 
Enrich recommendations for the routine and reactive course of 
actions, as described earlier. Had Enrich Products been aware 
of the presence of Legionella or Legionellosis cases at the VA 
University Drive campus, we would have definitely recommended 
implementing the reactive course immediately.
    Sometime in November, 2012 Enrich learned through the media 
that in fact there were reported cases of Legionnaires' Disease 
at the VA University Drive campus and that there were deaths as 
a result. In addition to the reporting of the outbreak the 
media, through quotes from the CDC and others, offered data on 
the efficacy of copper-silver ionization.
    Copper-silver ionization is an effective method of 
controlling Legionella bacteria. However, in order to maintain 
its efficacy, the installed system needs to be properly 
maintained and regularly monitored. Another important point to 
note is that in order to definitely know where the source of 
Legionella, or Legionnaires' Disease cases came from, testing 
must be conducted. Often it is assumed automatically that the 
source must be the hot water system in a facility. We have 
found a number of times, that sources were other than hot 
water, and more recently they have been identified from water 
features and ice machines.
    In conclusion, during the short time that Enrich worked 
with the VA University Drive campus through today, the VA has 
not shared its Legionella testing data or results with Enrich. 
If the investigation concludes a potable hot water system was 
the source of the outbreak, there is no question that regular 
testing could have detected the presence of the bacteria and 
that the reactive course of actions would have been 
implemented, at least we would have recommended it immediately, 
likely minimizing the risk of the outbreak.
    We hope to have the opportunity to work with the Department 
of Veterans Affairs in the future in an effort to reduce this 
risk at all of their facilities. We also hope to establish a 
dialogue with the CDC where we can share data and information 
demonstrating the real world experiences and successes of 
copper-silver ionization.
    Thank you, Chairman. And I would yield the remainder of my 
time.

    [The prepared statement of Aaron Marshall appears in the 
Appendix]

    Mr. Coffman. Thank you. Mr. Schira, you are now recognized 
for five minutes.

                   STATEMENT OF STEVE SCHIRA

    Mr. Schira. Thank you. I would like to thank the 
Subcommittee to allow us to try to assist in devising, 
learning, and understanding what goes on in an environmental of 
care in dealing with pathogenic bacterias such as Legionella.
    I am going to somewhat drop my offered statement here a 
little bit, because I was so shocked at some of the things I 
heard. First of all, much of what I have to say, which I will 
try to state where we physically were at the VA in two courtesy 
visits. But basically what Aaron has stated is in fact the gold 
standard, if you will, for how to maintain and operate a 
copper-silver system. It just requires, okay, a partnership 
between you and your client, your customer. We have more than 
1,400 systems installed for over 20 years. We know how to 
collaborate and work on the issues as Aaron has just analyzed, 
as well as what we were. We never got a call from the VA to 
come in and help. We had not heard from them for years. We 
collect a history datalogue sheet on every system that we try 
to have communications that logs their copper-silver, logs 
their Legionella, logs their ICPs, logs the cleaning cycle. We 
had zero on the four sheets for the four systems at the Oakland 
VA. We prompted a courtesy call back in December of 2011, where 
we went unsolicited to simply see if we could regenerate some 
dialogue with the facility. During that visit we were actually 
informed that there was potential problems with Legionella, 
they had sporadic shows, low levels. But we also were able to 
see in the walk through, that the systems were not being 
maintained, clearly the issue of maintenance of the flow cells 
and also the settings.
    The systems that are installed at the VA have what is 
called proportional control. They increase and decrease. There 
is no valves. There is no switching around, as was indicated. 
It is a computer that actually reacts instantaneously to the 
water demands on that hot water loop. So we are giving you more 
ions or less ions according to that water demand. We are also 
able to remote monitor that system and collect data minute by 
minute of what those systems, every one of those four systems 
at the Oakland VA, were capable of having such remote 
monitoring. They chose not to do it.
    Copper-silver as a disinfection technology has been, I 
would venture to say, more popular, more successful than 
chlorine or chlorine dioxide. We would be happy to contribute 
as much data and information to what those site visits we 
learned. One was, frankly, in April where three of our people 
were visiting with a Dr. Mutter, a Patty Harris, a Rodney Gutz, 
all of whom admitted that the systems were not being maintained 
as they should. One of the reasons for that was there was a 
gentleman who was in charge was out on disability and therefore 
the few people left did not really know what to be doing. We 
offered that we would jump in and do whatever we could possibly 
do, give them advice, give them the ability to remote, we told 
them we would clean the cells if necessary. We never got a 
response. Nobody ever came back to us.
    So what has occurred here is clearly, clearly a lack of 
true concern for the veterans that are being treated at that 
facility. Because since 1993, where a research study was done 
by Dr. Yu and Dr. Stout, and were able to control the 
Legionella after trying chlorine, chlorine dioxide, heat and 
flush, they were able to utilize the system we gave them in 
1993 and affect the right results.
    One last point as a matter of more chemistry than 
technology. If you are going to heat and flush, if you are 
going to hyper-chlorinate while you are trying to use a copper-
silver system, you might as well turn the copper-silver system 
off. Because you are throwing out all the ions when you are 
doing those flushes and operations. So, which we were never 
told. We had no idea they were doing these things. There are 
steps and actions you can take that could potentially work, and 
you want to do heat and flush that is okay. But we should know 
what you are going to do and collaborate how you are going to 
get the ions back up to where they are at. Thank you.

    [The prepared statement of Steve Schira appears in the 
Appendix]

    Mr. Coffman. Thank you for your testimony, Mr. Schira. Ms. 
Dahl, you have five minutes for your testimony.

                   STATEMENT OF KATHLEEN DAHL

    Ms. Dahl. Chairman Coffman, Ranking Member Kirkpatrick, and 
Members of the Committee, thank you for the opportunity to 
testify today. My responsibility as an AFGE local president is 
to present the safety concerns surrounding the current 
Legionella outbreak.
    Notification on November 16, 2012 that the hospital was 
going to water conservation due to elevated water samples for 
Legionella really was not heart stopping at that moment. As a 
nursing assistant that started in 1994, became an RN in 1995, I 
was often told, ``Do not drink the water,'' because Legionella 
had been in the pipes for a very long times. Hospital employees 
are surrounded by exposure risks everyday, be it TB, 
tuberculosis, the flu, Hepatitis, MRSA, C. Diff. But hospitals 
used isolation precautions, immunizations, masks, and other 
preventative measures everyday to reduce these risks. Why would 
Legionella be any different?
    It became heart stopping when I began to piece together 
media reports, employee reports, emails, and previous notices 
of emergency heat and flushes and problems with the pipes. I 
began to question exactly how long did the VA know about this 
and why were not preventative measures put in place? I grew 
concerned and requested to meet with Director Terry Wolf. She 
was not on campus at that time but promptly arranged a meeting 
with her leadership designees.
    Following that meeting, I really began to feel that 
employees were simply collateral damage, not even considered to 
be harmed or at risk. They were not provided protective gear. 
They were not provided notification to take precautions. I had 
employees that stopped me in the halls, coming to our office, 
and calling on the phone with concerns that they had assisted 
with the flushing and did not, they were not provided masks. 
Could they get it? How do I get it? Should the hospital be 
shutting down? They were in the hospital with pneumonia only 
four weeks prior to the notification. Was it related? Reports 
started coming in back in July and August of being hospitalized 
for five to six weeks. We instructed them to report to Employee 
Health, only to be turned away.
    AFGE immediately notified VA leadership that Employee 
Health had been turning the employees away, and they 
immediately corrected the problem. But the employees when they 
did go, they were told that they did not need a urine antigen 
test to see if respiratory illness was related to Legionella. 
After all, it was flu season. Legionella can be contracted in 
your homes. Or they were told it was too late to get tested 
because it was only good for 30 days and that they were not at 
risk. It only happens to immunocompromised people, people that 
are sick.
    Do not forget our employees. They are an aging population 
that are over 50. Some of them smoke, ex-smokers, some of them 
have diabetes, some of them are on chemotherapy and they come 
to work. They are immunocompromised. So they were at risk.
    OSHA guidelines are clear and AFGE shared them with 
leadership. When you have two or more positive cases of 
Legionella within 30 days, this is considered an in progress 
outbreak. The VA should be screening employees who are absent 
three or more days in a six-week timeframe in relation to these 
positive cases. This would have allowed early identification 
and information to employees that they were potentially exposed 
and provide the opportunity for a voluntary response. This 
would have allowed for timely testing and linking, or even 
better, ruling out Legionella exposure.
    Please do not forget the employees. Many of them are 
veterans themselves. They worked day and night to flush these 
pipes to reduce the Legionella without personal protective 
equipment and were not even instructed that they needed to. 
They were not screened or timely tested for Legionella as they 
should. They took care of our veterans during this time. They 
have a tough job, toileting and bathing patients that may or 
may not have control of their bodily functions. Imagine doing 
that without running water. They cleaned patients with hand 
wipes and small bottles of drinking water. There is pressure to 
not only hygiene the patients, but to prevent cross 
contamination of other infectious diseases.
    It is the law and VA policy to maintain safe environment at 
all times. We can do this by developing stronger policies that 
deal specifically with water interruption related to the 
existence of Legionella in our pipes and the construction. We 
can do this by better training those in the plumbing shop. Not 
all of them are plumbers. We can do this by having awareness 
and implementation of OSHA guidelines when sometimes occurs and 
protect the employees that provide to our veterans.
    Our Director Terry Wolf is genuinely concerned about the 
well being of the patients and the staff. I am confident that 
she is going to find solutions that prevent something like this 
from happening again. But the union needs to be part of this 
process in educating the employees and providing safe 
environments. It is the law and it is common sense. Thank you.

    [The prepared statement of Kathleen Dahl appears in the 
Appendix]

    Mr. Coffman. Thank you, Ms. Dahl. Dr. Stout or Dr. Yu, in 
your professional opinions were the deaths of the five veterans 
preventable?
    DR. Yu. Yes, absolutely. I write the chapters in Harrison's 
Textbook of Medicine, the most widely used textbook, up-to-
date, and all of the infections disease texts. And one of the 
points I make to physicians and medical students, that the 
mortality from Legionnaires' Disease with these new antibiotics 
that we have brought drops the mortality close to zero. So it 
does not have to be that we have knocked out the 40 mortality 
that we saw in hospitalized patients.
    So how did these patients die? First of all, we showed you 
could prevent it. Twenty-one consecutive years. The only way 
that they could have died was they did not get the antibiotic 
or they got it way too late, as they were dying. And the 30 
percent has been characterized. It is not that you ignore 
everything with 30 percent. As soon as it hits that danger 
point of 30 percent you go into red zone. Essentially what you 
do, and this was done and we monitored this at the Pittsburgh 
VA, infection control nurse looked at all the chest x-rays just 
to see if somebody with congestive heart failure may actually 
have Legionnaires' Disease and to see if they received the 
Legionella test. The culture is actually the best test. That 
disappeared after we left. The urinary antigen picks up 80 
percent. So another 20 percent were missed. Everybody in the 
ICU has to get a culture.
    So as soon as Legionella reentered the water supply, 
probably as early as 2007, because that was the first case 
after we left, and certainly after 2011 where you now have 16 
cases, you go into red zone alert. And this is what was done. 
The fact that Legionella had recontaminated the system, was not 
communicated to the emergency room physician, the hospitalist, 
or the intensive case physician.
    Mr. Coffman. Dr. Yu, thank you. So it was preventable. Dr. 
Stout?
    Ms. Stout. Well I would have to completely agree with that. 
And all you have to do is look at the history at the Pittsburgh 
VA to know that it was preventable. And I really do not know 
how much more evidence you need. We were using the same system. 
We were vigilant about monitoring for the ions in the cases. In 
fact, one of the things that is noted in the CDC report was the 
absence of the culture respiratory specimens of patients that 
were diagnosed by the urinary antigen test. Well when we were 
there, even if the physician did not order a Legionella culture 
of the sputum, we made sure that that sputum that he ordered 
for staph streptococcus was in the refrigerator and held for 
seven days. And we could go back to that sputum and recover 
Legionella and do the matching. And you know, these are things 
that should have been done there, should have been continued in 
our absence. And clearly they were not.
    Mr. Coffman. Okay. Mr. Marshall, was the Pittsburgh VA 
forthcoming with information that helped your company work with 
it better to detect and prevent Legionella in its water system?
    Mr. Marshall. Mr. Chairman, no. In fact, as I mentioned in 
my earlier testimony, Enrich never received an indication 
either verbally or written that there was a Legionella issue, 
or Legionella positivity in the water at their hospital. So the 
way that I perceive it is that we were not able, as an outside 
source, to do our job as effectively as we possibly could.
    Mr. Coffman. Thank you. Mr. Schira, did your company brief 
the VA in December of 2011 about poor results related to the 
Pittsburgh facility's water?
    Mr. Schira. Well first of all, we did not have any results 
as to what was going on. The only thing that actually was 
shared during that visit was that they were experiencing 
problems and had some issues. We never, either previously or 
even during the visit, had the opportunity to actually do 
copper test, or copper-silver tests. Or the ultimate test, of 
course, is the Legionella validation. So we were just operating 
from what we were told as to what was going on in their 
environment of care, which it now sounds like there was a lot 
more going on than we realized.
    Mr. Coffman. Thank you. Ranking Member Kirkpatrick?
    Mrs. Kirkpatrick. Thank you, Mr. Chairman. Let me just say 
this is an excellent hearing. I thank you very much for putting 
together these panels.
    Ms. Dahl, do you feel that you are being treated 
differently by the VA since you have assisted this Committee?
    Ms. Dahl.  I probably would not know that until I return to 
my place of duty.
    Mrs. Kirkpatrick. Were you told that your reference to four 
employees who had respiratory illness to the media could be a 
HIPAA violation?
    Ms. Dahl. I was advised that I was close to a HIPAA 
violation. I have quite a bit of awareness, as my profession is 
a nurse, to know that I did not provide any identifiers. But I 
was told by leadership that was close to it, and cautioned me 
when I speak with the press.
    Mrs. Kirkpatrick. Thank you for your testimony today.
    Ms. Dahl. Thank you.
    Mrs. Kirkpatrick. Mr. Schira, you indicated that the 
copper-silver system was not being properly maintained. What 
signs pointed you to this conclusion?
    Mr. Schira. Well the systems that we had provided to them, 
first of all, were to have attachments of flow meters so that 
the automatic computer can react to the water demand and those 
were not properly installed or in most cases not functioning. 
We were able to see that the ionization chambers when sitting 
or removed from the system were heavily caked with scale, which 
will prevent the amount of appropriate number of ions to be 
admitted. Also the systems were being run in a continuous mode 
as opposed to what would be a proportional control mode.
    Mrs. Kirkpatrick. Can you describe for us, what should be 
in place to have the proper maintenance for these copper-silver 
systems? What would be the proper way that they should have 
been handling this?
    Mr. Schira. Well basically what we do is, first of all, we 
do a start-up and training, which typically will take about 
three hours. We provide the facility with an education binder, 
a three-ring binder, which literally walks you through what the 
whole start-up and training is about. Then we work with 
infections control to find out how many distill sites they and 
the facility would like to test for the Legionella, the 
frequency of that testing. Also, we recommend, because the data 
can come up and we move it around, that you stay at, for one 
quarter, the same sites. So we can track to see exactly if 
there are any anomalies in what is going on. One of the key 
factors in paying attention to your environment of care on any 
system, but a copper-silver system of course in our particular, 
is knowing whether there are situations where rooms and distill 
sites are not being used. They actually start to create a dead 
link and are capable of generating Legionella, even though our 
system is installed and operating. That is why we have a three-
page protocol for flushing of inactive sites in the operation.
    And then the most important thing is share the data. Tell 
us what is going on so that we can contribute. And if it is 
remote monitoring, we can actually adjust the system remotely. 
So we will know exactly what your water demand was, what your 
amps, your volts, and how the system may be adjusted to be 
either more aggressive or potentially turned down. But it is 
data collection and consolidation of that data to be able to 
have a true environment of care view.
    Mrs. Kirkpatrick. And so it is constant maintenance? And 
that is something that you thought was missing at this 
particular hospital?
    Mr. Schira. That is correct.
    Mrs. Kirkpatrick. Thank you. I yield back the remainder of 
my time.
    Mr. Coffman. Thank you, Ranking Member Kirkpatrick. Dr. 
Murphy?
    Mr. Murphy. You said you tested some of the systems within 
the hospital? Am I correct in that?
    Mr. Marshall. We did not, Enrich did not test any of the 
systems. But what we did receive from the Pittsburgh VA was 
site records and lab copper-silver data, which is what----
    Mr. Murphy. Did you receive lab copper-silver data that 
said the readings were outside of their acceptable ranges?
    Mr. Marshall. Yes. In fact as I look at them now, the one, 
it is why I also like to know exactly where the cases happen.
    Mr. Murphy. Okay.
    Mr. Marshall. Because then we can, but in one system in 
particular, AA114, the levels for both copper and silver were 
below from June, 2011 until April, 2012.
    Mr. Murphy. Did you make a recommendation to the hospital 
that they should take some action?
    Mr. Marshall. Yes, of course.
    Mr. Murphy. Did they take any action?
    Mr. Marshall. Well the recommendations I made in my report 
was more or less based on a routine monitoring. And again, if I 
would have known more----
    Mr. Murphy. If you would have known there was Legionella 
cases you would have done something differently?
    Mr. Marshall. But even at that, I still requested 
increasing the frequency of their lab copper-silver testing. 
Simply because with a history of low levels that would have 
given us a better opportunity to make more timely adjustments.
    Mr. Murphy. Okay. Now Ms. Dahl, it has been stated that 
whoever was supposed to more or less manage, maintain, monitor 
this was out on disability. Were there sufficient staff within 
the VA system who had expert knowledge of how to manage and 
monitor this system available consistently throughout time?
    Ms. Dahl. I can only speak of my first, this year is my 
first year as local president. I have learned things that I did 
not know before, you know, regarding boiler plants and the 
plumbing and things of that nature. So I am not an expert to 
state. But I do know that there has been consolidation of, to 
build efficiencies in staffing. So we have combined duties to 
make, fit into the----
    Mr. Murphy. But I would, something like this, is this 
something that requires, for someone to work on these systems, 
requires some level of experience or training? Or can they 
simply walk on the job and look at the chart and do it?
    Ms. Dahl. They would need some form of training to know 
what to do with the information.
    Mr. Murphy. But we understand that the person who normally 
does this was out on disability, and so were other sufficiently 
trained staff available to your knowledge? If you do not know--
--
    Ms. Dahl. To my knowledge they had 15 minutes of training, 
what they reported to me.
    Mr. Murphy. All right. Thank you.
    Ms. Stout. Can I comment on the backside of that?
    Mr. Murphy. Yes.
    Ms. Stout. Just to point out that the VA's own policy 
indicates that there should be two fully trained individuals on 
how to operate this system at all times.
    Mr. Murphy. Are there two fully trained individuals on how 
to operate this system at the VA? Do any of you know that? If 
you do not know----
    Ms. Dahl. I do not know.
    Mr. Murphy. Mr. Schira, I want to read you something from a 
timeline the Committee has here. It says, ``Liquitech 
reports,'' and this is April 16, 2012, ``that they completed a 
site visit with contractor regarding new system as well as 
facilities and infection prevention regarding existing systems. 
The contractor, Tomco, and VMS people were having issues 
connecting the systems up. Nika and John resolved these issues. 
The LTI team visited each system and met with IP and facility 
management. We were told that the gentleman who normally takes 
care of our systems was out on leave or disability and the 
remaining maintenance staff did not know how to maintain the 
systems. Furthermore, they had not been doing weekly testing or 
regular maintenance. When the LTI team went into the 
maintenance shop, LTI personnel encountered Oakland VA staff 
fabricating,'' as in falsifying, ``handheld copper records. 
Upon visiting the systems, there was obvious evidence that the 
systems had not been regularly maintained and flow meters were 
not working. Infection prevention said they had some dark water 
issues.''
    Sir, to your knowledge is it true that someone was 
fabricating this data?
    Mr. Schira. I believe so, yes. We queried the three people 
who are on site. Two were very experienced, knowledgeable 
engineers. And the term of whipping copper levels is where you 
simply, to respond quickly----
    Mr. Murphy. How did you query the people? And please put 
your microphone right in front of you, if you would?
    Mr. Schira. Oh, I am sorry.
    Mr. Murphy. That is okay. How did you query these staff 
who, someone physically observed someone writing down false 
information?
    Mr. Schira. Correct. These were three of my employees.
    Mr. Murphy. And your employees saw someone else writing 
down information?
    Mr. Schira. Correct.
    Mr. Murphy. Was it from lack of training? They didn't know 
what to do? They just, they didn't understand how to write down 
the data? Did you query to find out?
    Mr. Schira. No. It was somewhat embarrassing so they did 
not even comment.
    Mr. Murphy. Was that brought to the attention of the VA, or 
to anybody else to find out what----
    Mr. Schira. Unfortunately, no.
    Mr. Murphy. And because of this information was registered, 
did it come out then that the copper ionization levels were 
acceptable?
    Mr. Schira. I believe that is what was being documented on 
the sheet, yes.
    Mr. Murphy. You know, I have got to tell you. A few years 
ago when I joined the Navy, I did it to try and help a lot of 
our wounded soldiers when they were coming back and coming in 
the hospital. And what I am hearing here is deeply disturbing. 
That either we have weak or absent standards of what we should 
be doing, weak adherence to standards, or some incredible 
negligence that led to the death of five people. I yield back.
    Mr. Coffman. Thank you, Dr. Murphy. Mr. Walz?
    Mr. Walz. Well, thank you. First of all, my comments here 
is that some of the accusations that were made here, I am going 
to put in for the record, Mr. Chairman, that I think these 
witnesses should have been sworn in, or still should be. 
Because the accusation of knowledge of a crime of this 
magnitude is a pretty serious accusation. My question now is 
are we going to get names? Are those people involved in this 
going to have recourse? So for the record, I would counsel 
that. With that in mind, witnesses, we all here want to get the 
best care for our veterans the best way possible and find out 
what's going on. But there have been some pretty serious 
accusations. If they prove true, someone should be prosecuted, 
someone should go to jail. But I hope all our witnesses 
understand to make such a statement in this setting holds very 
serious consequences. So with that, and not to further the 
stereotype of passive-aggressive Minnesotans, I just do have a 
couple of questions.
    I did dovetail on that, Ms. Dahl, I am concerned for your 
workers. The government, a government entity should always set 
the standard in terms of workplace safety, workplace protocols 
that are in place. I myself do not know, that is why I think 
Dr. Murphy's questions were correct. Were we following 
protocol? Were we putting your people in a position? I think 
that is something this Committee needs to follow up on. And I 
pledge to you, that is what we will do.
    Mr. Marshall, do other companies share their data with you, 
that you have this installed with?
    Mr. Marshall. Well first of all, this is not our equipment.
    Mr. Walz. Okay.
    Mr. Marshall. So but yes----
    Mr. Walz. Are you on contract to the VA to maintain the 
equipment?
    Mr. Marshall. No.
    Mr. Walz. Okay.
    Mr. Marshall. We service equipment all over North America, 
and we also sell equipment all over North America. This was not 
our equipment, but they were familiar with us helping them or 
other facilities in the Pittsburgh area, and asked us to come 
in and just put a new set of eyes on it.
    Mr. Walz. Okay. Mr. Schira, you said that no one told you 
or whatever. Are you under contract to the VA to provide that 
type of counsel? So were you prepared to do that pro bono? Are 
you prepared to do that today, to go in there pro bono?
    Mr. Schira. We did two site visits at no charge trying to 
learn what was going on.
    Mr. Walz. So if they choose to use you, though, they are 
going to have to pay you. And we are going to have to go 
through the contracting procedures that are put in place. So it 
would not be unusual for them to not share that data with 
someone who is looking for a contract? Would you say that is 
fair?
    Mr. Schira. Yeah. I would say if you interpret sharing the 
data is simply a financial motivation for technologies like us. 
That is not the purpose. The purpose is to validate the 
efficacy of the system. And the only way we know what that 
validation is, is by you sharing it.
    Mr. Walz. I agree. And there are protocols to do this. I 
thought it was getting intimate, at that folks were ignoring 
you and had they listened to you things could have been better. 
I think there might be some data that would need to be first 
before they entered into such a contract to prove that. Is that 
true?
    Mr. Schira. Well I think we have the data and the track 
record that actually does provide that and prove it. We are 
installed in more than 15 VA hospitals that we are able to work 
with. So we have history that can----
    Mr. Walz. Did this VA hospital handle it different than 
your other ones?
    Mr. Schira. Mostly from lack of communications.
    Mr. Walz. Okay. All right. Doctor, you and Dr. Stout, you 
again, some pretty strong statements. You said knowing the 
history of this VA. Could you tell me your history with that VA 
center?
    Ms. Stout. I started to work at the Pittsburgh VA as a 
graduate student in 1980. And then I went on to be employed at 
the Pittsburgh VA starting in 1983. And my work there with Dr. 
Yu was to basically understand Legionnaires' Disease 
transmission, prevention, not only at the Pittsburgh VA but for 
health care facilities nationwide.
    Mr. Walz. And I want to be clear that the research you have 
done is greatly appreciated. When you look up Legionella.org it 
is you, and it is the two of you. So I want to be very clear on 
that and the work you have done there. I also want to be very 
clear, it is the 800-pound gorilla in the room. Is it safe to 
say there is some history between the two of you and the 
Pittsburgh VA?
    Ms. Stout. Well as was actually brought up by the Chair, I 
believe, in 2006, and people probably do not know this, the 
chapter that then had sued happened because I had worked for 
the VA since 1983 and this is 2006, and never asked for a 
raise. When I asked for a raise, after getting a masters 
degree, a Ph.D., and national prestige for the VA, the 
administrator said, ``Give her a raise? And why do we even need 
the Special Pathogens Laboratory? I think I will close it and 
make Dr. Stout,''----
    Mr. Walz. Is that on official record?
    Ms. Stout. Yes, it is part of the testimony----
    Mr. Walz. From 2008?
    Ms. Stout.--from 2008. And I also, just because Mr. 
Moreland brought it up, I want to share with the Committee, you 
know, this is the result of the 2008 investigation. Which 
showed clearly that our collection of isolates was a well 
catalogued, very well maintained----
    Mr. Walz. So you dispute the comments that it was----
    Ms. Stout.--not a bunch of broken glass and----
    Mr. Walz. So you do dispute that point on the----
    Ms. Stout. Absolutely. And I do not dispute it. The hearing 
proved that it was untrue. And I am astonished that it was 
asserted here today. Amazing. It really calls into question the 
testimony of Mr. Moreland.
    Mr. Walz. Doctor, how did you end your employment with the 
VA?
    Dr. Yu. I was fired. And I was fired because they closed 
the Special Pathogens Lab. But we had specimens that had to be 
processed and they came from some of the most famous hospitals 
in the United States and public health agencies if they 
suspected an outbreak. And I said, ``You are closing it? But we 
have got all of these that we are processing.'' So they said, 
``Stop processing them.'' And I wrote a letter to Specter and 
to Mr. Moreland. I had a choice between my conscience as a 
physician to process these samples that were being sent to look 
at outbreaks, or I could stop. So I processed them and that was 
the reason I was fired.
    Mr. Walz. Did you go through due process? Did you go to 
court over your firing?
    DR. Yu. It turns out that I am a University of Pittsburgh 
professor with tenure, as many, many of the VA deans hospitals 
are. And they said that I had no recourse.
    There is one anecdote that you would be interested in. One 
of the specimens that we processed turned out to have 
Legionella. And we, and it turned out they were having an 
outbreak. So we informed them that, ``You have an outbreak. 
Your cultures are all positive for Legionella.'' And then 
because I was fired, because I processed those cultures, the 
health care facility's manager emailed me because this had 
become national news. And thanked me for doing them this 
service because they now recognized that the Legionella in 
their patients had come from that in the water and that they 
recognized that they----
    Mr. Walz. You know as a layman, I have to tell you on this, 
and I say this not because I have any expertise on that, but 
because of the nature of it, I represent the Mayo Clinic area 
and have had numerous encounters with this. Biobanking is very 
complex. I had a critical access hospital that was nearly 
closed and went through six years of fights because a lab had a 
broken centrifuge and they carried it to another lab. The two 
of you know this is serious business. This is serious, the 
slightest breaks in protocol on biobanking are certainly 
reasons for recourse. Is that an untrue statement? And that 
biobanking----
    Ms. Stout. I do not really follow your logic there. What 
are you talking about, breaks in, what are you----
    Mr. Walz. The protocol. This issue of saying that you 
processed them afterwards. From a layman's perspective, I think 
there is great frustration. If we had samples here, and said 
that they could have helped on this, how those samples are 
collected, and the chain of custody of them, and how they are 
done is so critically important. One lab test carried in a 
hospital from one lab to another broke the protocol of that and 
almost closed down the entire hospital because of contamination 
and all of those issues. So my question here is, is no one is 
denying the value of the research but how the research is 
conducted is critically important. Is that correct? Am I wrong 
on that, Dr. Stout?
    Ms. Stout. Well all I have to say is that after months of 
investigation what the Committee found, which is the Committee 
on Oversight and Investigation in Science and Technology is 
that there was absolutely nothing wrong with the protocols that 
were being followed at the Pittsburgh VA in the Special 
Pathogens Laboratory.
    Mr. Walz. So in recourse then I would have assumed that you 
would have gone to court to right your wrong, your grievances.
    Ms. Stout. One of the things that I always say is that as 
an employee in the laboratory service, I was able to be 
represented by the union. Without representation by the union, 
I would have been fired without the ability to defend myself. 
With the union's help, I successfully defended myself against 
various accusations which were patently false.
    DR. Yu. Let me answer your question directly. Because I 
think you are implying that maybe if we mislabeled something, 
left a tube out, hey, that is good enough reason to destroy the 
whole collection. Is that what you are saying?
    Mr. Walz. I am not saying it is good enough reason. But I 
am saying that those protocols are into effect.
    Dr. Yu. Right. And so----
    Mr. Walz. And you both know that. If you----
    Dr. Yu. Yes, I agree with you.
    Mr. Walz. That is a serious violation.
    Dr. Yu. It is a serious violation. Dr. Melham said that 
that is the reason she destroyed it and she mentioned that in 
the televised hearing. But when she was deposed in a lawsuit 
she said she never, she never gave that order. It was done by 
four employees without her knowledge.
    Mr. Walz. Okay. Well I just, Mr. Chairman, and I apologize 
for going down the road. The question I always have is trying 
to find this. I think myself a sense of frustration that maybe 
a third person in this field maybe should have been here too, 
because there is a history. And that does not invalidate your 
testimony. It certainly does not invalidate the work that you 
have done. I think it brings into question, especially when 
strong accusations are made of criminal behavior, it brings 
into question the validity of that. And I think that undermines 
our ability to get at the heart of this. So thank you for your 
patience on that.
    Mr. Coffman. Let me just remind the witnesses and read from 
a little section that was sent to you. And it says, ``Please be 
reminded that testimony requested or pursuant to this is 
governed by the applicable provisions of Section 1001, 1505, 
and 1621 of Title 18, United States Code, which dictate 
penalties pertaining to submitting intentionally false 
statements to the Committee, or knowingly falsifying or 
concealing pertinent facts related to inquiries made by the 
Committee.''
    With that, I have got a few questions. Oh, I am sorry, Mr. 
Rothfus?
    Mr. Rothfus. I yield back.
    Mr. Coffman. Okay. Mr. Schira, what is the remote 
monitoring system, or RMS, and why is it important?
    Mr. Schira. The remote monitoring system allows, if they 
are willing to tie it in, allows us to see minute by minute the 
activity of the individual computer and controller as to how 
much amperage, voltage, and GPM is, oh I am sorry, I keep doing 
that, how much amperage is required to maintain the targeted 
levels of copper and silver ionization. This is recorded. It is 
graphed and documented all automatically with no intervention 
on the customer's part or our part, and it all goes to a Web 
site that collects the data which is accessible to the 
individual customer, their infectious control personnel, their 
engineering staff, etcetera. So it just gives us another 
insight to really seeing what is going on in that environment 
of care.
    Mr. Coffman. Did the Pittsburgh VA have the remote 
monitoring system?
    Mr. Schira. They had the capabilities. We had provided them 
with systems with the computer boards that was capable. But 
they chose not to connect them to a modem that would have 
allowed that remote monitoring access.
    Mr. Coffman. Ms. Dahl, have you experienced any retaliation 
related to your scheduled appearance here, or in any other role 
at the Pittsburgh VAMC?
    Ms. Dahl. I have not been retaliated for my testimony here 
today. Like I said, I will not know how people will respond 
until I return to my duty station.
    Mr. Coffman. Any intimidation?
    Ms. Dahl. I have been advised that I did not have to come. 
I do not think I was, in a mean way. It was just----
    Mr. Coffman. Were you encouraged not to come?
    Ms. Dahl. I was told I could be sick.
    Mr. Coffman. Really?
    Ms. Dahl. Yes, sir.
    Mr. Coffman. And who told you that?
    Ms. Dahl. The associate director.
    Mr. Coffman. Okay. When did they tell you that?
    Ms. Dahl. The Friday before I left.
    Mr. Coffman. Okay. Mr. Schira, did your company provide 
training and written documentation to Pittsburgh VA personnel?
    Mr. Schira. Yes, we did. Over probably easily three or four 
years with the institution of the newer model systems, and on-
site training was provided to the various facilities people.
    Mr. Coffman. Okay. Ranking Member Kirkpatrick?
    Mrs. Kirkpatrick. I yield back. Thank you, Mr. Chairman.
    Mr. Coffman. Thank you, Ranking Member. Mr. Murphy?
    Mr. Murphy. Thank you, Mr. Chairman. I am curious for 
everyone who has worked at the VA hospital, and I go back to, I 
remember once being at a ceremony at VA Pittsburgh receiving 
some national recognition for its superb record of dealing with 
hospital acquired infections. And I have talked to many people 
over the years and that has helped me with learning and push 
forth some legislative issues in terms of how to handle 
hospital acquired infections and reduce them. It is a serious 
concern. I think it causes about 50,000 lives a year and maybe 
$100 billion or so. Or maybe I have those numbers reversed. But 
let me ask this. Dr. Yu to start, when you were at the VA 
system in Pittsburgh and what was the protocol when there was 
some infectious disease outbreak? MRSA or something else? Were 
staff generally notified when there was an infectious disease 
that was----
    Dr. Yu. Sure. The 30 percent rule was not that you just 
ignore everything.
    Mr. Murphy. I mean, with any infectious disease.
    Dr. Yu. Yes. It is standard to certainly notify the staff 
because they are at the front lines.
    Mr. Murphy. But do you think that helped the VA develop a 
stellar record in terms of handling infections, because staff 
were notified fairly quickly?
    Dr. Yu. Yes.
    Mr. Murphy. And so, like I say, anything like Methicillin-
resistant Staphylococcus aureus, or central line infections, or 
pneumonia, any communicable disease. How were staff usually 
notified when there was an outbreak?
    Dr. Yu. Well, I was in charge of all of that when I was 
there. And we did it through a combination. I met with all the 
interns and residents, because it is a teaching hospital. An 
infection control practitioner met with all the nurses. And 
then we gave conferences. And then I rounded with the intensive 
care unit physicians, because they handle the sickest patients. 
And we notified them of, ``You have to wash your hands. 
Legionella has come back into the water system. And so forth.''
    Mr. Murphy. And other----
    Dr. Yu.--very strong contact.
    Mr. Murphy. Would this have been done within a week, a day, 
an hour, I mean, immediately?
    Dr. Yu. Immediately.
    Mr. Murphy. Okay. And Ms. Dahl, for employees of the VA 
hospital system, are there standards also set in terms of 
notification timing of employees when there is an infectious 
disease outbreak that you might be aware of?
    Dr. Yu. Yes. When we are, we have protocols in place for 
things like the MRSA, and things that you, there are screening 
tools that identify a person, that they need isolation 
precautions. So the staff use gowns and things of that sort. 
With the Legionella, you know, again, I learned all my 
information from googling OSHA guidelines as far as Legionella 
goes. And one of the things that they first said was that we 
should screen the employees that had been out for six weeks as 
soon as they noticed that there was an outbreak, which was two 
or more positive cases. So I immediately brought that to the 
attention of leadership because I was concerned that we were 
not going to do that. And I was told that that would be a HIPAA 
violation to screen for that and send out letters. And I had 
argued that it was a Legionella outbreak and not a HIPAA 
violation.
    Dr. Yu. We also notified the patients and if they had 
Legionnaires' Disease, all of them lived, so it was no big deal 
that you have Legionnaires' Disease, we are treating you for 
this. And we did that with MRSA patients as well.
    Mr. Murphy. Dr. Yu, I just wanted to clarify something too. 
You said there was zero Legionnaires' Disease between 1997 and 
2006?
    Dr. Yu. 1996 to 2001.
    Mr. Murphy. 1996 to 2001.
    Dr. Yu. It was in 2005, they have one there. But we have a 
memo from the hospital director that says exactly the same 
years. Ten years, there were none.
    Mr. Murphy. So with regard to my questioning regarding 
following protocol if there was an infectious disease outbreak. 
We have already heard testimony that when Legionella was 
discovered in the water system, medical staff were not 
immediately notified. Is that your experience, Ms. Dahl? That 
people were not notified?
    Ms. Dahl. Yes, sir.
    Mr. Murphy. And do you have any, what was that lapse of 
time between an official notification, not what you may have 
found on the Internet but an official notification, and the 
others?
    Ms. Dahl. The first notification that I had as the local 
president was on the 16th of November, 2012. That there was a 
problem, we were going to water conservation. I received a call 
from the director.
    Mr. Murphy. And what was the date, do you recall what the 
date was that they actually detective Legionella in the system 
then?
    Ms. Dahl. When I met with them on the 20th, leadership at 
the VA, to inquire about the situation with Legionella, I had 
asked, ``When did you first know that there were patients that 
were positive Legionella?'' And they had generally stated at 
least a couple of weeks prior, earlier in the month.
    Mr. Murphy. Okay. I am just trying to establish how much 
time between when the hospital knew and you were notified. We 
will have to check that in the record, too. Ms. Dahl, you 
mentioned that the associate director said to you that you 
could be sick today. Who is that associate director?
    Ms. Dahl. Her name is Lavita Ford.
    Mr. Murphy. Was that a private meeting?
    Ms. Dahl. It was.
    Mr. Murphy. So no one else was present?
    Ms. Dahl. No, sir.
    Mr. Murphy. Any notes taken of that meeting? Any emails? 
Anything else?
    Ms. Dahl. No.
    Mr. Murphy. All right. Thank you. I yield back.
    Mr. Coffman. I want to thank the panel for your testimony 
today, and thank you very much. And this panel is concluded 
now, excused.
    The Chair would now like to call Mr. Michael Moreland back 
to the witness table. Thank you, Mr. Moreland. Mr. Moreland, 
what is the training for Pittsburgh VA employees in running the 
sterilization system and how much training was provided?
    Mr. Moreland. I really do not have the details on that. I 
know that they met with the vendor. I am sorry, but I do not 
know the details of the exact minutes and time. I know that 
they met with the contractor to have an orientation to the 
system. But I do not have that at the tip of my tongue.
    Mr. Coffman. Are there supposed to be two FTE, or full-time 
equivalent employees, assigned at all times to run the system 
as was stated? And how many were at Pittsburgh VAMC?
    Mr. Moreland. I know that the policy prior to its more 
recent talked about recommending two people. But the most 
recent policy, which I will have to pull out and reference, 
requires two people to be there at all times.
    Mr. Coffman. And were there two people there at all times?
    Mr. Moreland. I do not know that for a fact.
    Mr. Coffman. It would really help to have the people that 
we asked to be here to testify that would in fact have that 
information, would it not?
    Mr. Moreland. I can find that information for you, sir.
    Mr. Coffman. For the record? What was the reason for 
removing Dr. Stout?
    Mr. Moreland. Dr. Stout was not removed. She resigned.
    Mr. Coffman. And Dr. Yu?
    Mr. Moreland. Dr. Yu was, his services were not longer 
required because as mentioned he was doing work that was not 
authorized and not needed at the VA.
    Mr. Coffman. What is the VA's response to the fabrication 
of results?
    Mr. Moreland. I am not aware and I do not recall ever 
having seen any information about that. If there was concern 
that that occurred, it would have been my expectation that that 
would have been communicated to the VA Pittsburgh so that we 
could have taken action to address that concern.
    Mr. Coffman. Ranking Member Kirkpatrick?
    Mrs. Kirkpatrick. I yield back my time.
    Mr. Coffman. You are dismissed. Thank you.
    Mr. Moreland. Thanks.
    Mr. Coffman. My thanks to the panel. VA Pittsburgh has been 
caught manipulating their own data to cover poor maintenance of 
the copper-silver system. VA has been caught intimidating its 
own employees, both those who wanted to convey information to 
their fellow employees about potential unsafe working 
conditions, as well as those testifying today. Make no mistake, 
the VA will be closely scrutinized for its actions towards 
those who have testified here today and towards employees who 
do the right things. Furthermore, there has been a serious 
breakdown in how the VA assessed its responsibility in 
diagnosing and reporting Legionella. There was a dismal failure 
in the VA following its own policy and CDC guidance in 
addressing Legionella. There was a tragic failure in leadership 
at the local level, the VISN level, and at the VA central 
office level. And in the end, five veterans died. Five veterans 
died that we know of. And others, both veterans and employees, 
became very ill.
    This hearing was necessary in order to accomplish a number 
of items. One, there must be an accounting for the failures 
that have been identified through hard evidence. Two, the VA 
central office needs to strengthen the inherent weakness of the 
infection control program office, thoroughly reviewing the 
reports and plans from well performing facilities and applying 
those practices elsewhere. Three, there needs to be a unified 
focus from CDC, the VA, and other organizations to ensure 
everyone knows what to do, everyone can be held accountable, 
and that this travesty never happens again. Four, within 30 
days, I expect the VA to contact my Subcommittee staff and in a 
bipartisan fashion we will chart out a road ahead. With that, 
this hearing is adjourned.

    [Whereupon, at 1:08 p.m., the Subcommittee was adjourned.]



                            A P P E N D I X

                              ----------                              

           Prepared Statement of Hon. Mike Coffman, Chairman
    Good morning. This hearing will come to order.
    I want to welcome everyone to today's hearing titled ``Analyzing 
VA's Actions to Prevent Legionnaire's Disease in Pittsburgh.'' I would 
also like to ask unanimous consent that several of our Pennsylvania 
colleagues be allowed to join us here on the dais today to hear about 
an issue very specific to their constituents. Hearing no objection, so 
ordered.
    Today's hearing is based on a recent outbreak of Legionnaire's 
Disease at the Pittsburgh VA Medical Center. At least 29 recent cases 
of Legionnaire's Disease have been associated with the Pittsburgh VAMC. 
While VA has stated that eight of these cases were definitely not 
contracted at their hospital, it has also stated that it cannot 
determine whether 16 of these cases were contracted at the hospital.
    VA contacted the CDC last fall to investigate the issue. The CDC's 
report, just released on Friday, not only determined that many veterans 
likely contracted Legionnaire's Disease through the Pittsburgh VA 
health care system but that, tragically, five veterans have died over 
the past two years from Legionnaire's Disease acquired at the hospital. 
The CDC report paints a more complete picture, and it turns out that 
problems originated much earlier than what VA has stated and are much 
more widespread. While VA's public acknowledgment of Legionella 
bacteria in the water at Pittsburgh VAMC did not occur until November 
2012, the Subcommittee in the course of its investigation uncovered a 
great deal of evidence that officials at the Pittsburgh VAMC were aware 
of serious problems with their water sterilization system well before 
this time.
    What's more--this outbreak was more than likely preventable.
    This event is rooted to the history of the Special Pathogens Lab 
that at one time was the hallmark of the Pittsburgh VAMC and the 
flagship of Legionella research across the globe. Its abrupt closure in 
2006, under questionable circumstances, was followed by a congressional 
hearing in 2008 that led to the exoneration of Dr. Stout and Dr. Yu, 
the Lab's directors, and the admonition of VA. But the loss of the 
Special Pathogens Lab and the experts within it directly impacted VA on 
both a local as well as a national scale.
    According to VA's own documents, the Legionella protocol in place 
at Pittsburgh from 1997 to 2006 resulted in no hospital acquired 
Legionnaire's Disease. This protocol mandated testing copper-silver 
levels and Legionella testing every other month. How is it that a 
successful system is now blamed for the problems in Pittsburgh?
    VA also tells us that Legionella is a national problem. I agree 
that there should be a more comprehensive program with a single focal 
point. However, VA provided documents to this Subcommittee stating 
that, as of December 17, 2012, there have been only five Legionella 
cases across the entire VA health care system, and all five cases were 
community acquired. Even basic news reports tell us that these numbers 
are far from accurate. Does VA even know how many cases of 
Legionnaire's Disease exist in its patients and where they could have 
originated?
    The recent CDC report indicates VA either has no idea or is 
deliberately downplaying what actually happened. The deaths of five 
veterans- and the many other cases of Legionnaire's Disease- are 
nothing to be downplayed.
    I understand that different agencies have different protocols for 
preventing and responding to Legionella bacteria. It is my wish that 
today's discussion and the recent outbreak in Pittsburgh can provide an 
opportunity for appropriate agencies put forth a unified effort to 
establish a national framework on addressing Legionella. From that 
framework, local protocols can be put in place so that a local facility 
can respond appropriately. This Subcommittee is not advocating for any 
one method of Legionella treatment - just that whatever proven system 
is put in place be used correctly. Regardless of the method, what 
happened in Pittsburgh could have been prevented, and veterans have 
unnecessarily paid the price.
    I look forward to a thoughtful discussion today on what VA 
officials knew about Legionella in the water at the Pittsburgh VAMC, 
when they knew it, and what actions they took to address this serious 
problem in a responsible and timely manner. However, I am disappointed 
that, despite several requests to VA from the Subcommittee, no one from 
the Pittsburgh VAMC who was there during the incident is here to 
deliver first-hand knowledge of events. Hopefully the witnesses that 
are here today can, at the very least, recommit to the Department 
following its own protocols and holding accountable those employees who 
fail to do so.

                                 
        Prepared Statement of Hon. Robert L. Jesse, M.D., Ph.D.
    Good morning, Chairman Coffman, Ranking Member Kirkpatrick and 
Members of the Subcommittee. Thank you for the opportunity to discuss 
the cases of Legionnaires' disease identified at the Department of 
Veterans Affairs' (VA) Pittsburgh Healthcare System (VAPHS). I am 
accompanied today by Mr. Michael E. Moreland, Director, Veterans 
Integrated Service Network 4, and Dr. Gary Roselle, National Director, 
VHA Infectious Diseases Service.
    VA is committed to providing quality care to our Veterans and has 
partnered nationally and locally in an ongoing effort to understand and 
control Legionella. Legionnaires' disease is a form of pneumonia caused 
by a bacterium known as Legionella, discovered and named following an 
outbreak of pneumonia among attendees of a July 1976 American Legion 
convention at the Bellevue Stratford Hotel in Philadelphia. 
Legionnaires' disease is contracted by breathing in an aerosol (mist or 
vapor) of water containing the Legionella bacteria. The disease is not 
contagious and cannot be transmitted from one person to another. Most 
people exposed to the bacteria do not become ill, though patients who 
are immune-suppressed are most at risk.
    According to the Centers for Disease Control and Prevention (CDC) 
website, between 8,000 and 18,000 people are hospitalized with 
Legionnaires' disease or Legionellosis in the United States each year. 
However, it is likely that many Legionella infections are not diagnosed 
or reported, so this number may be higher. In a recent publication, CDC 
reported that Legionellosis is increasing in the United States with an 
increase of 217 percent reported through surveillance between 2000 and 
2009. This publication reports the highest age-adjusted incidence rate 
is found in the Middle Atlantic region (New York, New Jersey, and 
Pennsylvania).
    As a national health care system, the Veterans Health 
Administration (VHA) recognizes that there are two critical components 
to the management of Legionella in its facilities. The first consists 
of surveillance of both clinical infection of patients and the presence 
of Legionella in the environment. The second is preventing the growth 
of Legionella in the facilities' water systems. VHA has one of the most 
comprehensive Legionella prevention policies in the United States, 
including very specific algorithms for annual evaluation of risk at the 
facility level. The VHA Policy requires an annual evaluation of 
facility risk. For example, in transplant centers, VHA specifically 
directs twice-yearly testing of water samples, consistent with CDC 
guidance. VA Pittsburgh is a transplant center and performs water 
sampling at a rate more frequent than the VHA Policy or CDC require. Of 
note, the CDC makes no recommendations regarding long-term, 
supplemental systemic treatment of hospital water systems to prevent 
Legionella growth. Several supplemental treatment systems exist 
including copper-silver ionization and several methods of chlorination. 
These are in addition to the primary prevention strategy which is 
control of water temperature limits for the hot water distribution 
system. While these practices will not entirely eliminate the 
possibility of hospital acquired Legionella, the risk of it can be 
substantially reduced.
Background on Legionella Prevention at VA Pittsburgh Health Care System 
        (VAPHS)
    Legionella is naturally present in water and is particularly 
prevalent in the area around Pittsburgh, and is most problematic in 
late summer through the fall. Legionella prefers warm water, and can 
grow at temperatures as high as 115 degrees Fahrenheit. As a result, 
there is a need to maintain the hot water supply at a temperature that 
can balance the risk of Legionella growth versus the risk of scalding 
individuals. Generally, this is done by maintaining a temperature 
gradient that is high at the source but reduced at the taps.
    It is expected that Legionella would be sporadically detected in 
some VAPHS water samples, and this has been the case over the years. 
Regardless of whether the levels detected met VAPHS thresholds for 
action, the facility would typically perform remediation when detection 
levels rose. When Legionella is confirmed in a facility's water system, 
two methods of remediation are most commonly used in this country; 
super-heating or hyper-chlorination of the water. For VAPHS, 
remediation included super-heating of water systems where feasible as 
well as manual disinfection of water outlets. Remediation is not always 
successful and successive remediation efforts may be required to reduce 
Legionella contamination.
    Additionally, VAPHS has used a supplemental, continuous copper-
silver ionization system to maintain long-term suppression of 
Legionella bacteria in the water supply. Ion levels may be affected by 
water pH or other elements present in municipal water systems. The 
protocol for the routine examination of the water system and copper-
silver Legionella control consisted of visual checks of the amperage 
and voltage of the copper-silver ionization system, monthly rotation 
and cleaning of the flow cell units of the copper-silver ionization 
system and periodic water sampling to evaluate ion levels. The copper-
silver ionization system requires frequent monitoring and ion levels 
may vary based on fluctuations in the character of the incoming 
municipal water source. More recently, continuous chlorine infusion 
into the water supply has been introduced as a method of Legionella 
suppression. The long-term solution is a plumbing project which will 
add instantaneous water heaters and mixing valves in order to maintain 
consistently high hot water temperatures while preventing the risk of 
scald injuries. This will be coupled with a chlorine dioxide water 
treatment system, which will provide Legionella suppression to all 
water entering the facility.
Recent Cases of Legionella
    On October 5, 2012 a Legionella specimen from two patients and one 
from an environmental culture were transmitted to the CDC via a 
protocol that involved the state and local public health authorities. 
The purpose was to determine if the patients might have a hospital-
acquired infection even though they had limited contact with VAPHS. 
Following this, a third patient was diagnosed and a specimen was sent 
to CDC on October 23, 2012. A positive relationship, i.e., DNA sub-type 
similarity between the patient and environmental strains of Legionella, 
for the first two patients was communicated to VAPHS on October 30, 
2012, at which time these two were counted among the hospital-acquired 
Legionnaires' disease group. Working again through Allegheny County 
Health Department (ACHD) and the Pennsylvania Department of Health 
(PDoH), VAPHS requested assistance from CDC, and on Nov 7, 2012 a team 
representing CDC, ACHD, and PDoH arrived at VAPHS to initiate their 
case review and environmental assessment.
    The CDC used its water sample collection technique, which results 
in a more sensitive screening process. For the patient case review, 
they expanded the definition of the incubation period for Legionella 
pneumonia in order to capture the widest possible number of Veterans 
who may have been infected. When the first 44 water sample tests were 
complete, more than half of them demonstrated Legionella growth.
    During the course of the collaborative review by VAPHS and the CDC, 
a total of 29 cases of Veterans with Legionella pneumonia were 
identified from January 1, 2011 through November 2012. Five of those 
cases were confirmed to have originated at VAPHS. Of the five cases 
confirmed as hospital-acquired, four patients recovered and one died 
within 30 days of the Legionnaires' disease diagnosis. The Veteran who 
died suffered primarily from congestive heart failure, but Legionella 
pneumonia was listed as a contributing cause of his death. Sixteen 
cases were identified to have had contact with VAPHS, which means that 
they may have contracted the disease at the VAPHS but a definitive 
determination cannot be made. CDC refers to these cases as ``probable 
hospital-acquired''. Eight cases were determined to be community-
acquired, meaning that they contracted the infection outside of the 
hospital. It is important to note that none of the probable or 
confirmed cases was in a transplant patient.
    CDC confirmed the linkage of Legionella in the water supply with 
pneumonia patients in a communication that VAPHS received on October 
30, 2012, and on November 15, 2012, after performing its environmental 
assessment, CDC recommended remediation. VAPHS promptly instituted an 
aggressive, multiphase water remediation effort. Phase one of this 
effort involved superheating the potable water system from 160 to 170 
degrees Fahrenheit and then flushing this system with a goal of 
eliminating any existing Legionella bacteria. Due to the complexity of 
the water systems, the heat and flush procedure was successfully 
implemented at some, but not all, parts of the water system. As an 
added measure, VAPHS then hyper-chlorinated its water system per CDC 
guidelines and instituted water-use restrictions. Water restrictions at 
University Drive and H.J. Heinz campuses were initiated on November 16, 
2012. The restrictions were lifted on November 30, 2012 at the 
University Drive campus after water cultures, which require two weeks 
to process, confirmed successful remediation. On December 7, 2012, the 
restriction was lifted at the H.J. Heinz campus. VAPHS continues to 
conduct water testing at various locations in the water distribution 
system, every 2 weeks as per CDC recommendations and protocol. 
Bimonthly water testing will continue until CDC recommends lower 
frequency of testing and any areas testing positive are immediately 
remediated.
    VAPHS had concerns about Legionella growing in water samples with 
sufficient copper-silver ion levels, and there had been numerous past 
adjustments to the copper-silver ion levels in response to both low and 
high levels of one or the other ions. As a result, VAPHS took the 
copper-silver ionization system off-line. VAPHS also instituted a 
continuous chlorine drip to help maintain control of Legionella levels 
in the water system until a permanent supplemental treatment strategy 
is formalized.
    VAPHS had been balancing the need for maintenance of high hot water 
temperatures with the need for preventing scald injuries, which 
resulted in water temperatures that were low enough to permit the 
growth of Legionella. The decision regarding the circulating hot water 
temperature was made with the belief that copper-silver ionization 
provided sufficient supplemental protection. However, as previously 
noted, the performance of this system, its maintenance and monitoring, 
is complex and may have failed to consistently prevent Legionella 
growth.
    VAPHS has also chartered a water safety committee, which will be 
charged with the oversight of efforts to maintain effective 
communication about water safety and oversight of monitoring and 
remediation efforts throughout the facility. The chairperson is the 
associate director and the group will have representation from 
facilities management, infection prevention, and laboratory service. 
The committee will report to the medical center's executive leadership 
board.
Outreach Efforts
    VAPHS proactively contacted local media and provided a brief 
summary of the findings, the status of remediation efforts, the number 
of confirmed hospital-acquired cases of Legionella at VAPHS to date 
(5), and the number of probable cases to date (16). On November 16, 
2012, VAPHS leadership activated an incident command center and tasked 
this center with clarifying facts and communicating news and updates to 
Veterans and employees. A call center was established to answer 
questions from Veterans, staff, and family members. All inquiries were 
addressed by the call center staff or referred to the Director of 
Infectious Disease for resolution. In addition, VAPHS leadership held 
Town Hall meetings with employees at all three VAPHS campuses. VAPHS 
public affairs department also notified local congressional offices, 
union partners, and the media about the presence of Legionella in the 
VAPHS water system and the identification of patients with Legionella 
pneumonia. VAPHS has identified and attempted to contact all known 
Veterans diagnosed with Legionella pneumonia, but whose source of 
infection is unknown. For patients where community acquired 
Legionnaires' disease was suspected, VAPHS proactively offered to test 
the water systems in the homes of these individuals and access to our 
medical experts in order to determine if the source of infection was in 
their home. To date, in response to this request, no samples were 
received. Finally, the VAPHS public affairs department has been posting 
pertinent updates and information in various places on VAPHS' internal 
and external Web sites, http://www.pittsburgh.va.gov. The designated 
call center remains open and Veterans can contact the call center at 
(412) 360-1199. Any employees with questions relating to Legionella 
have access to an e-mail group that will address their questions and 
concerns. Legionella updates were provided at recent employee town hall 
meetings and a Veteran roundtable event.
Summary
    VAPHS is following the recommendations of the numerous external and 
internal review teams, such as superheating and hyper-chlorinating the 
water system among other remediation efforts. These efforts have 
successfully reduced Legionella in the water supply. Our ability to 
provide the best care to our Veteran patients improves through this 
expert consultation and analysis. VHA is committed to the prevention of 
Legionella and is continually looking to update best practices for 
prevention.
    Chairman Coffman and Ranking Member Kirkpatrick, VA is committed to 
providing the highest quality of care that our Veterans have earned and 
deserve and continues to take appropriate actions to ensure the safety 
and protection of our patients. We deeply regret that any Veteran was 
exposed to Legionella bacterium at VAPHS.
    We appreciate the opportunity to appear before you today. My 
colleagues and I are now prepared to answer your questions.

                                 
                 Prepared Statement of Dr. Lauri Hicks
    Good morning Mr. Chairman and other distinguished Members of the 
Committee. My name is Lauri Hicks, and I am a medical officer at the 
Centers for Disease Control and Prevention (CDC), within the Department 
of Health and Human Services. Thank you for the opportunity to speak to 
you today about CDC's epidemic assistance investigation (Epi-Aid) into 
a Legionnaires' disease outbreak at the Veterans Affairs (VA) 
Pittsburgh Healthcare System in Pittsburgh, Pennsylvania. I also want 
to extend my deepest sympathies to the patients and their families 
affected by this outbreak.
    Today, I will provide some background on Legionnaires' disease and 
CDC's role in these types of investigations. I will then provide 
specific details on CDC's epidemic-assistance investigation (Epi-Aid) 
at the Pittsburgh VA Medical Center, a description of our findings, and 
our proposed recommendations.
Legionnaires' disease
    In 1976, CDC in cooperation with other Federal, State, and local 
authorities launched one of the largest joint disease investigations in 
history following an outbreak of severe pneumonia among the 
participants of the American Legion Convention in Philadelphia. This 
investigation led to the identification of the previously unrecognized 
bacterium, Legionella, and the establishment of Legionnaires' disease 
(LD). Legionella is a type of bacteria found in fresh water. Outbreaks 
of legionellosis have occurred after persons have breathed mists that 
come from a manmade water source, such as building potable water 
systems (i.e., through exposure to faucets and showers), air 
conditioning cooling towers, whirlpool spas, or decorative fountains 
contaminated with Legionella bacteria. Most people who are exposed to 
Legionella do not get sick, but Legionella can cause a severe form of 
pneumonia, referred to as LD. The illness most often affects the 
elderly, those who smoke cigarettes or have chronic lung disease, and 
persons whose immune system are suppressed by diseases such as cancer, 
kidney failure requiring dialysis, or diabetes.
    Legionella does not spread from person-to-person. LD can usually be 
successfully treated with antibiotics, but it does lead to death in 5-
15 percent of cases. CDC estimates that between 8,000 and 18,000 people 
are hospitalized with LD in the United States each year.
    Even though Legionella may be present in fresh water systems, 
finding it there does not necessarily mean it is the source of 
someone's illness. There is not a clear relationship between the amount 
of Legionella in the water and risk for disease, and therefore there is 
no safe level of Legionella in a water system. When Legionella is 
identified in a water system, CDC recommends that measures be taken to 
remove the bacteria from the water, known as remediation. The most 
frequently used initial remediation measures include superheating or 
hyper-chlorinating the water system. These methods do not usually lead 
to permanent removal, so a long term plan for prevention of Legionella 
growth is almost always necessary.
The CDC role in epidemic assistance investigations (Epi-Aids)
    CDC provides rapid assistance to States and Federal agencies, as 
well as international organizations and ministries of health, through 
formal requests for epidemic-assistance investigations (Epi-Aids). 
Since 1946, CDC has conducted more than 5,000 investigations. Epi-Aids 
always are performed collaboratively with the requesting partners and 
with the goal of controlling an epidemic and preventing future 
epidemics attributable to the same or related causes. The specific 
objectives of an investigation are to define the parameters of the 
epidemic (i.e., time of illness onset and conclusion of the epidemic, 
number of cases, and morbidity and mortality), to identify control or 
prevention measures, and possibly to identify new data relevant to the 
epidemiology of the health problem.
    When CDC is invited to conduct an Epi-Aid, the general role of its 
investigators is to assist with: verifying the diagnosis and developing 
a list of hypotheses for the cause of the outbreak; establishing a case 
definition; collecting and analyzing data; categorizing cases as 
possible, probable, or confirmed on the basis of available data and 
knowledge; evaluating the hypotheses as to the outbreak's cause based 
on the data collected; determining and implementing control measures; 
using surveillance to assess the control strategy; and writing and 
disseminating the final report. The report provides the requesting 
public health officials with an explanation of the extent of the 
outbreak and potential causes, which enables timely and effective 
public health action. The report identifies the risk factors that 
resulted in the epidemic, and it is disseminated to the health 
authorities and persons who requested assistance with the 
investigation.
CDC's epidemic-assistance investigation (Epi-Aid) at the VA Pittsburgh 
        Healthcare System
    CDC works 24-7 to save lives and protect people from harm, and this 
investigation illustrates the power of public health in action both to 
identify serious health problems and to coordinate a targeted response 
that protects our nation and its citizens from infectious disease 
threats.
    On October 5, 2012, the Pennsylvania Bureau of Laboratories 
contacted CDC Legionella laboratory to request subtyping of some 
Legionella isolates at the VA Pittsburgh Healthcare System (VAPHS).
    On October 12, 2012, CDC received two clinical isolates and one 
environmental isolate for sequence-based typing (SBT). On October 29, 
2012, CDC reported preliminary results indicating a link between these 
two cases of LD with onsets of illness on August 25 and August 27, 2012 
and an environmental Legionella isolate collected from the VAPHS 
University Drive Campus on October 3, 2012. CDC notified the 
Pennsylvania Department of Health (PA DOH), which notified the 
Allegheny County Health Department (ACHD) for further investigation. A 
conference call was held on November 5, 2012 with CDC, VAPHS and others 
and, upon learning of the results, the VAPHS Director promptly 
requested a visit from the CDC.
    PA DOH requested an Epi-Aid on November 2, 2012. After discussion 
and with the agreement of VAPHS on November 6, 2012, CDC sent two 
Epidemic Intelligence Service (EIS) Officers and one microbiologist to 
Pittsburgh to join the ACHD and PA DOH EIS Officers and epidemiologists 
in the investigation. The field investigation began on November 7, 2012 
and the last member of the field team left Pittsburgh on November 16, 
2012. The objectives of this Epi-Aid were to: 1) Identify additional 
cases of LD among patients at VAPHS; 2) Complete an environmental 
assessment of LD risk and environmental sampling for Legionella at the 
hospital; and 3) Recommend interventions to prevent ongoing disease 
transmission.
    For background purposes, I would like to provide a brief 
description of the VAPHS. The VAPHS serves the veteran population 
throughout the tri-state area of Pennsylvania, Ohio, and West Virginia, 
and has three campuses in Pittsburgh. The University Drive campus, 
``the hospital'', is a 150 bed acute-care hospital that opened in 1954 
and provides inpatient and outpatient services. The H.J. Heinz campus 
houses primary care clinics, a long-term care facility, substance abuse 
program, and dental rehabilitation. The Highland Drive campus serves 
only administrative functions. Since 2007, electronic medical records 
have allowed computerized linkage of patient care information across 
all campuses.
    In May 2004, VAPHS was approved for an almost $200 million major 
construction project and underwent extensive construction work on all 
campuses, beginning at the University Drive campus in January 2009.
    VAPHS uses copper-silver ionization to control Legionella in its 
water distribution system. The process of copper-silver ionization 
releases positively-charged copper and silver ions into the water, 
which form electrostatic bonds with negatively charged bacteria cell 
walls. This bond is thought to disrupt bacterial cell walls and lead to 
cell death.
Case-finding
    To identify additional cases, CDC queried two databases for LD 
cases occurring between January 1, 2011 and October 31, 2012. We 
searched the Pennsylvania National Electronic Disease Surveillance 
System (PA-NEDSS) for Legionnaires' disease cases for which VAPHS was 
mentioned in the case entry. We also searched the VAPHS's electronic 
medical records for positive laboratory results for Legionella-specific 
respiratory culture and Legionella urine antigen testing.
    Using a medical chart abstraction form developed for this Epi-Aid, 
and with the help of the infection prevention team at the hospital, we 
classified cases into definitely healthcare-associated, probably 
healthcare-associated, and not healthcare-associated and collected 
epidemiologic, clinical, and exposure data on cases. A probable case 
had exposure to VAPHS, including but not limited to: overnight stay, 
outpatient visit, visitor, employee, and volunteer, during a portion of 
the 2-14 days prior to onset, and a clinical respiratory isolate was 
not available for molecular testing to confirm whether the clinical and 
environmental isolate were the same. We requested all available patient 
isolates for subtyping at CDC's Legionella laboratory. VAPHS reported 
all new-onset cases directly to the Epi-Aid team following their 
departure from Pittsburgh.
    We identified five definitely and 16 probably healthcare-associated 
cases of LD, for a total of 21 cases. All cases were patients who had 
been exposed to VAPHS before the CDC-recommended interventions were 
implemented. The median age of the 21 healthcare-associated case-
patients was 64 years. All case-patients were male. All case-patients 
were Pennsylvania residents except for one from West Virginia. All 
cases were in patients at VAPHS; none were staff or visitors. Five 
case-patients or 24 percent died within 30 days of a positive 
diagnostic test for LD. All 21 cases had Legionella urinary antigen 
testing performed and nine of these also had Legionella-specific 
culture performed. In 13 cases, the exposure was only to the University 
Drive campus, in two cases only to the Heinz campus, and in six cases 
to both.
Environmental Assessment and Evaluation
    The environmental investigation, which was conducted on the 
University Drive campus, began on November 7, 2012 with a visual 
inspection of the healthcare facility to determine possible sources of 
aerosolized water. This included patient care areas, waiting areas, 
decorative fountains, and cooling towers. We reviewed the potable water 
system, including visual inspection of the instantaneous hot water 
heaters and distribution system as well as three copper-silver 
ionization flow cells and controllers. Additionally, we reviewed 
blueprints and process flow diagrams of the potable water system with 
the facility manager.
    We discussed the hospital's layout, equipment, and maintenance 
practices with the hospital facilities and infection prevention staff. 
The staff provided verbal information and written records regarding 
construction work on campus and associated water outages; measured 
copper and silver levels, maintenance logs, and a consultative report; 
pH measurements; Legionella-specific culture results; date and site of 
emergency remediation measures; and their written protocol for 
Legionella risk-reduction.
Results of Environmental Sampling
    For our environmental sampling for Legionella, CDC collected 
specimens in tandem with the hospital infection preventionists at their 
routine sampling locations. We also collected additional samples later 
that same day from patient care areas, central distribution points, and 
the decorative water fountain according to standard CDC sample 
collection protocol. We measured total chlorine, pH, and temperature 
and collected samples for copper and silver concentrations at 
representative locations throughout the potable water system.
    Twenty-nine of 44 environmental samples collected by our field team 
in November showed growth of Legionella. Legionella grew from samples 
collected from various locations throughout the potable water system, 
including from all samples collected from sites immediately after the 
copper-silver systems, indicating widespread Legionella colonization 
throughout the hospital. Distal sites testing positive included patient 
care areas, the sink of the intensive care unit room of one probably 
healthcare-associated case, and a shower in a room used for liver 
transplant patients.
    Clinical Legionella isolates from three cases were identical and 
matched environmental isolates collected from multiple locations in the 
hospital's potable water system. This strain of Legionella was the 
outbreak strain. There were several other types of Legionella found in 
addition to the outbreak strain. Also, a sample from the sand filter of 
the decorative fountain at the entrance showed growth of the outbreak 
strain; therefore the fountain cannot be ruled out as a potential 
source of exposure for some cases.
    Copper and silver levels were measured in 11 water samples in 
tandem with Legionella testing at routine sampling locations; seven 
samples were from distal sites, and four were collected from sites 
immediately before or after copper-silver flow cells. For copper, the 
mean concentration was 0.33 parts per million (ppm) at central sites, 
and 0.24 ppm at distal sites.
    For silver, these mean concentrations were 0.04 and 0.02 ppm, 
respectively. Seven of 11 samples were within the manufacturer's 
recommended range for Legionella control for both copper and silver. 
However, all 11 samples showed growth of Legionella, and nine were 
positive for the outbreak strain.

    Our environmental assessment and evaluation identified the 
following factors and policies that contributed to the outbreak:

      There was persistence of a highly pathogenic strain of 
Legionella in the potable water system despite copper-silver ionization 
and intermittent superheating during the past two years. At the time of 
our investigation, the copper and silver levels in the water were 
appropriate for controlling Legionella according to the manufacturer's 
recommendations and the hospital's protocol. However, these same 
samples still tested positive for Legionella, indicating that the 
copper-silver ionization system was not controlling Legionella growth. 
The diversity of species, serogroups, and serotypes among Legionella 
isolates makes resistance to copper-silver ionization an unlikely 
explanation for amplification within the system, and points to an 
environment adequate for Legionella growth, indicating a systemic 
problem that was not being controlled by the copper-silver ionization 
system at the time of sample collection. The hospital collected small 
volumes (100 ml) of water for routine culture-based monitoring of the 
potable water system for Legionella. Compared to the 1 L volumes 
recommended by CDC, this smaller volume likely resulted in decreased 
sensitivity to detect widespread colonization of the potable water 
system.
      The hospital relied upon an action threshold (30 percent 
of distal sites positive) to prompt remediation. Cases occurred when 
sampling indicated that less than 30 percent of sites were colonized. A 
recent review determined that the 30 percent threshold provides both 
low specificity (74 percent) and sensitivity (59 percent) for 
legionellosis risk assessment. CDC's records on known outbreaks from 
2011 revealed two outbreaks where Legionnaires' disease cases occurred 
after exposure to building water systems with Legionella positivity at 
less than 30 percent of distal sites.
      The hospital has been undergoing extensive construction. 
The timing of construction work at the hospital coincides with the 
outbreak. Construction likely introduced organic matter to the potable 
water system, increasing consumption of chlorine in the municipal water 
supply leading to amplification of Legionella. Residual chlorine in the 
water system, although at adequate levels in the incoming municipal 
water supply, was at an insufficient concentration for microbicidal 
activity at all distal sites measured within the hospital.

    In addition, the following epidemiologic and surveillance factors 
were found to contribute to the outbreak:

      The hospital did not recognize healthcare-associated 
cases of LD for an extended period of time. A low index of suspicion 
that lab-confirmed cases were healthcare-acquired can be partially 
attributed to a perception of Legionella control in the hospital water 
systems.
      The cases reported to county and state public health 
offices were not recognized to be healthcare-associated and part of an 
outbreak. This may be due to a high baseline prevalence of 
Legionnaires' disease in Pittsburgh.
CDC's Findings and Recommendations
    CDC findings and recommended interventions to prevent ongoing 
transmission of LD at the VAPHS have been detailed in a report provided 
to the VAPHS and the PA DOH.
    The CDC investigation revealed a large number of healthcare-
associated LD cases during 2011-2012 and widespread colonization of 
Legionella in the hospital's potable water system. These cases occurred 
in the setting of a comprehensive Legionella risk-reduction program 
consistent with national Veterans Affairs and county health department 
guidelines. This program included disease surveillance, environmental 
testing, and a long-term disinfection system for control of Legionella 
in the potable water.

    CDC made some initial recommendations to stop disease transmission, 
which included:

      Minimize patient exposure to potable water sources. There 
are several ways to do this, including restricting patient showering, 
restricting drinking from potable water sources, installing point-of-
use filters for faucets and showerheads, and turning off all decorative 
water features and whirlpool spas until remediation strategies have 
been shown to be effective.
      Implement short-term systematic potable water system 
remediation as referenced in American Society of Heating, Refrigerating 
and Air-Conditioning Engineers, Inc. ASHRAE Guideline 12-2000: 
Minimizing the risk of legionellosis associated with building water 
systems, 2000:

    I   Hyperchlorination to greater than or equal to 2 ppm at all 
distal sites and flushing at all points of use , and/or
    I   Superheating and flushing of the potable water system to 160-
170 degrees.

    CDC also recommended enhanced testing and surveillance for LD to 
identify any new cases.
    Additionally, CDC made recommendations for long-term Legionella 
control measures, including:

      The long-term disinfection system for prevention of 
Legionella growth in the hospital's potable water system should be 
reevaluated in consultation with experts.
      The facility should strive for eradication of Legionella 
from the potable water system, as there is no known safe level of 
Legionella.
      The hospital should continue testing for Legionella every 
two weeks for three months, and then every month for three months to 
ensure remediation has been effective. If any Legionella is detected 
during this time frame, remediation throughout the facility will need 
to be adjusted and the testing cycle must start over.
      LD surveillance should be conducted at the hospital 
according to CDC recommendations, with a strict case definition and 
action upon identifying one definite or two possible healthcare-
associated cases.
      Close communication among hospital staff and between the 
hospital and public health would improve surveillance.
      The Legionella control protocols of the hospital, the 
Veterans Health Administration, and the Allegheny County Health 
Department should be carefully reevaluated to include changes in 
surveillance methodology, including action thresholds and sampling 
methods.
      The hospital should modify their Legionella sample 
collection procedures. Both swabs and 1L water bottles should be 
collected at various sampling sites, with samples processed as soon 
after collection as possible and results communicated to infection 
preventionists, building facilities manager, hospital administrators, 
and CDC. Chlorine, pH, and maximum temperature should be measured at 
the water heaters and at least a couple of distal sites.
      A standard operating procedure for appropriate 
maintenance, including regular cleaning, of decorative fountains should 
be drafted and followed. Facility managers should consult with the 
manufacturer of the decorative fountain to determine an acceptable 
biocide for Legionella control.
Conclusion
    The VAPHS has rapidly implemented CDC's recommendations and has 
taken several steps to protect patient safety. The hospital shut down 
their potable water system on November 15, 2012 to initiate 
remediation. Meanwhile, a combination of bottled water and point-of-use 
filters were used for patient care needs. Superheating and 
hyperchlorination were performed, followed by installation of a 
chlorine drip to maintain the chlorine level at approximately 1-2 ppm 
throughout the system. Repeat sampling two weeks later showed that 
remediation was successful, and water usage restrictions were lifted on 
November 30, and the VAPHS declared the water system clear of 
Legionella. To date, no further LD cases have been detected.
    I would be happy to answer any questions the Committee may have.

                                 
                Prepared Statement of Victor L. Yu, M.D.
    I was Chief of the Infectious Disease Section at the VA Medical 
Center, Pittsburgh, Pennsylvania for 30 years and received superior 
performance evaluations for each of these 30 years. I was also Chief of 
the Special Pathogens Laboratory (SPL) instituted under the aegis of VA 
Central Office during the Legionella outbreaks of the late 1970s. In 
the late 1970's, outbreaks of hospital-acquired legionellosis occurred 
throughout the VA hospitals: 200 cases at Wadsworth VA (CA) in 4 years, 
50 cases at Togus VA (ME) in 2 years, 100 cases at Pittsburgh VA (PA) 
over 3 years. In 1996, the SPL was established as a Special Clinical 
Resource Center by Thomas Cappello, previous director of the VA (see 
Appendix).
    Our accomplishments are matter of record garnering honors from the 
VA, NIH, International societies and for me, the most treasured one, 
from the American Legion.

    These are a few of many key discoveries

      Dr. Janet Stout's discovery of the source in 1982 -the 
hospital drinking water. This was a controversial discovery not well-
accepted by CDC for many years. They believed cooling towers were the 
source. This discovery suggested that prevention was possible.
      The SPL and the Department of Engineering at the 
University of Pittsburgh then instituted a systematic process of 
discovery and evaluation of possible disinfectants against Legionella 
in the drinking water. We were the first to either introduce and/or 
evaluate these methods in a controlled fashion:

    --Superheat and Flush (Lancet, 1983)
    --Chlorination (Lancet 1985)
    --Copper-Silver Ionization (Water Research 1996, Am J Infect 
Control 1997, Infect Control Hosp Epidemiol 2003)
    --Chlorine dioxide (J Am Water Work Assoc 2004)
    --Monochloramine (APIC abstract, 2012)

      The SPL developed and evaluated all the microbiologic 
methods in current use today. The culture media for isolation from 
water and from patients that is commercially available today was 
formulated by the Special Pathogens Laboratory. We performed the first 
comparative evaluation of the urinary antigen test for Legionella and 
found it to be accurate. This test is now the most common method used 
for diagnosis today.
      Most importantly, we formulated the strategy of using 
Legionella contamination of the hospital drinking water as the key 
parameter for assessing risk in the hospital - an approach opposed by 
CDC. However, several US states, most of Western Europe and Taiwan have 
adopted this approach.
      Our greatest discovery for the purpose of this Hearing 
was that the Special Pathogens Laboratory evaluated the antibiotics 
that could kill Legionella. The ones that were promising were 
commercialized by the pharmaceutical industry and we confirmed their 
effectiveness in FDA-approved patient studies of azithromycin, (Z-
Mycin, Pfizer) and levofloxacin (Levaquin, Ortho McNeil). In a larger 
U.S. study for FDA approval, we found levofloxacin dropped the 
mortality of Legionnaires' disease to 0%. This was confirmed by a large 
Spanish study of epidemic Legionnaires' disease in which the mortality 
was again 0% (zero).

    From 1991-2006: 21 consecutive years, not a single case of 
hospital-acquired Legionnaires' disease occurred at the Pittsburgh VA. 
Compare this with subsequent numbers of cases seen at the Pittsburgh VA 
from 2007 to today (See Table in Appendix).
    The Pittsburgh VA is an excellent medical facility with the 
superior physicians and capable healthcare staff. As the VA physicians 
well know, bureaucrats often dominate the VA system in ways not 
conducive to optimal care. This case is an unusually extreme and 
unfortunate example. I remain a loyal VA physician and feel dismayed 
that these bureaucrats have tarnished the reputation nationally and 
undermined its reputation for the veterans who obtain their care there.
    With the closure of the Special Pathogens Laboratory, Senator Arlen 
Specter (R-PA) and the American Legion expressed concern about patient 
care. Mr. Moreland stated that the problem had been solved and we were 
no longer needed. Congressman Brad Miller (D-NC) from the 2008 
Congressional Hearing decrying the destruction of our treasured 
scientific collection stated ``We will never know how many patients 
will die because of the VA's action''. He was wrong. Today, you know of 
at least 5 deaths at the Pittsburgh VA. Ironically, this was the 
hospital in which a zero percent mortality rate was first reported with 
antibiotic therapy. The most likely reason is that they did not receive 
the antibiotic at all or received the antibiotics too late.
    We learned at this Hearing today that the fact that Legionella had 
re-entered the drinking water of the Pittsburgh VA in 2011 had been 
withheld from the physicians in the Emergency Room, the hospital ward, 
and most importantly, the nurses and physicians in the ICU. These 
veterans never had a chance.
APPENDIX
    Special Pathogens Laboratory and Disinfection
    VA Cases of hospital-acquired Legionnaires' disease
    Credentials of Dr. Yu
    Reasons for Dr. Yu's ouster from Pittsburgh VA
    Publications of Legionnaires' disease from Pittsburgh SPL

Appendix: Special Pathogens Laboratory and Disinfection
         Special Pathogen Laboratory - Position on Disinfection
Background
    Dr. Janet E. Stout and the Pittsburgh Special Pathogens Laboratory 
made the crucial discovery of finding the source of hospital-acquired 
Legionnaires' disease in 1982. To everyone's surprise, especially US 
CDC which had linked cooling towers to hospital-acquired Legionnaires' 
disease, the actual source was found to be the drinking water of the 
hospital. Although controversial initially, scientific validation was 
soon forthcoming. Once this source was discovered, prevention became 
possible by disinfecting the drinking water such that Legionella would 
no longer grow and propagate.
Disinfection Modality-General Approach
    Over the next 30 years the Special Pathogens Laboratory, in 
conjunction with the University of Pittsburgh Department of 
Environmental Engineering, formulated and devised innovative approaches 
to disinfection and evaluated their efficacy in hospitals. All the 
methods in use today were first evaluated in controlled studies by SPL. 
These included heat and flush, hyperchlorination, ultraviolet (UV) 
light, copper-silver ionization, chlorine dioxide and monochloramine.
Specific Disinfection
    Super heat and flush was the first modality tried. This method 
proved effective but it was tedious in that every faucet and showerhead 
needed to be flushed with hot water for at least 30 minutes (Best 
1984). Patient care areas were flushed twice! This method is still used 
during emergencies and can be implemented immediately since no special 
equipment is needed.
    Chlorination or Hyperchlorination. The Special Pathogens group was 
the first to perform a controlled evaluation of chlorination in the 
world (Lancet 1985). This method became the predominant method as 
numerous hospital outbreaks were uncovered. Unfortunately, we found 
that this method had distinct disadvantages. Chlorine concentrations 
had to be monitored compulsively; if chlorine concentrations dropped 
below disinfection levels, Legionella quickly re-entered the water 
distribution system. This led to inconsistent efficacy. Corrosion of 
the water distribution system with pinholes leaks occurred in the 
piping such that flooding occurred behind the walls. Public health 
studies established that chlorine was a carcinogen.
    Ultraviolet (UV) Light. While UV light is an effective method of 
disinfection, we were unsure of its efficacy if used on a water 
distribution system to control Legionella in downstream faucets. So we 
placed a UV unit on a hospital water system and tested for Legionella. 
UV was consistently effective only if used in combination with a 
systemic disinfectant and prefiltration (Liu- 95 Water Research)
    Copper-Silver Ionization: This new modality was assessed by SPL in 
a laboratory model and a plumbing system. Copper-silver penetrated the 
biofilm of the pipes and eradication persisted for up to three months 
even if the copper silver was withdrawn thus providing a margin of 
safety (Liu 98 CID). Moreover, it had no odor and caused notably less 
corrosion than chlorination. It quickly emerged as the dominant 
disinfection modality worldwide. This system was installed at the 
Pittsburgh VA Medical Center in 1994 after experience in other 
hospitals showed efficacy. Legionella disappeared from the drinking 
water and the incidence of Legionnaires' disease approached zero at the 
Pittsburgh VA (Stout 98). Independent evaluation at 16 medical centers 
proved it was highly effective (Stout ICHE 2003); 16 hospitals using 
copper-silver ionization over 5 to 11 years represented the final step 
in a proposed 4-step evaluation process of disinfection systems (see 
below for Stout Criteria).
    Chlorine Dioxide: This modality was introduced in Europe where it 
proved disappointingly ineffective. Johns Hopkins instituted chlorine 
dioxide and found that Legionella could be adequately controlled; 
however, it took about one year before Legionella control could be 
sustained. We initiated the first controlled evaluation of chlorine 
dioxide in the United States and also found that efficacy required 
almost one year of disinfection (Sidari JAWWA 2004). We ultimately 
performed two more field evaluations with similar results (Zhang 2007, 
2009). However, there were numerous advantages such as the ability to 
treat large volumes of cold water in multiple buildings. A study has 
not yet been done providing confirmatory reports from multiple 
hospitals during a prolonged time. Consequently, chlorine dioxide has 
fulfilled only 3 of the 4 Stout criteria (see below) and we have 
recommended its installation in selected facilities.
    Monochloramine: We have completed the first U.S. evaluation of a 
new system capable of on-site generation of monochloramine in a 
Pittsburgh hospital. Preliminary results are promising (Kandiah 2012).
Stout Criteria
    In 2003 we proposed that all disinfection systems undergo objective 
evaluation that includes four steps:

    a. demonstrated efficacy of Legionella eradication in vitro using 
laboratory assays

    b. anecdotal experiences in preventing Legionnaires' disease in 
individual hospitals,

    c. controlled studies in individual hospitals

    d. validation in confirmatory reports from multiple hospitals 
during a prolonged time

    To date, copper-silver ionization is the only disinfection modality 
to have fulfilled all four evaluation criteria.
Conclusion
    In all of our consultations for disinfection with numerous medical 
centers in the U.S., we have never requested nor received a finder's 
fee for recommending a specific disinfection modality. Evidence-based 
medicine is the criteria for our recommendations. Advantages and 
disadvantages exist for each individual modality. What works at one 
hospital may not be ideal for another. Water quality, pH, and the 
network design of each hospital will affect our recommendation. In 
addition, the susceptibility of the patients at that hospital (e.g. 
transplant patients are at higher risk than ambulatory patients) are 
also considered. All options are presented and every recommendation is 
transparent.
    In summary, we have been leaders in the design and application of 
Legionella disinfection systems. We have acted mainly as researchers in 
academia. As consultants for hospitals requiring disinfection, we 
receive no financial incentive from any commercial manufacturers.
Publications
    Best M, Yu VL, Stout J, Goetz A, Muder R, Taylor F. Legionellaceae 
in the hospital water supply: epidemiologic link with disease plus 
evaluation of a method for control of nosocomial Legionnaires' disease 
and Pittsburgh pneumonia. Lancet 2:307 310, 1983.
    Best M, Goetz A, Yu VL. Heat eradication measures for control of 
nosocomial Legionnaires' disease: implication, education, and cost-
analysis. Amer J Infect Control 12:26-30, 1984.
    Goetz A, Yu VL. Screening for nosocomial legionellosis by culture 
of the water supply and targeting high risk patients for specialized 
laboratory testing. Amer J Infect Control 19:63-66, 1991.
    Goetz A, Yu VL. Copper-silver ionization: cautious optimism for 
Legionella disinfection and implications for environmental culturing. 
Am J Infect Control 25:449-451, 1997.
    Kandiah S, Yassin MH, Rahman H, Ferrelli J, Fabrizio M, Porter L, 
Duda S. Control of Legionella Contamination with Monochloramine in a 
Large Urban Hospital Hot Water System. Poster Presentation: Infectious 
Disease Week, San Diego, CA. 2012.
    Lee TC, Stout JE, Yu VL. Factors predisposing to L. pneumophila 
colonization in residential water systems. Arch Environ Health 43:59-
62, 1988.
    Lin YSE, Stout JE, Yu V, Vidic RD. Disinfection of water 
distribution systems for Legionella. Semin Resp Infect 13:147-159, 
1998.
    Lin YSE, Vidic RD, Stout JE, Yu VL. Legionella in water 
distribution systems. J Amer Water Works Assoc. 90:112-121, 1998.
    Lin YE, RD Vidic, JE Stout, VL Yu. Individual and combined effects 
of copper and silver ions on inactivation of Legionella pneumophila. 
Water Research 30:1905-1913, 1996.
    Lin YSE, Vidic R, Stout JE, McCartney CA, Yu VL. Inactivation of 
mycobacterium avium by copper and silver ions. Water Res 32:1997-2000, 
1998.
    Lin YSE, Stout JE, Vidic R, Yu VL. Negative effect of high pH on 
biocidal efficacy of copper and silver ions in controlling Legionella 
pneumophila. Appl Environ Microbiol 68:2711-2715, 2002.
    Lin YE, Stout JE, Yu VL. Controlling Legionella in hospital 
drinking water: an evidence-based review of disinfection methods. 
Infect Control Hosp Epidemiol 32:166-73, 2011.
    Lin YE, Stout JE, Yu VL. Prevention of hospital-acquired 
legionellosis. Curr Opin Infect Dis. 24:350-2356, 2011.
    Liu Z, Stout JE, Tedesco L, Boldin M, Hwang C, Diven W, Yu VL. 
Controlled evaluation of copper/silver ionization in eradicating 
Legionella from a hospital water distribution system. J Infect Dis 
169:919 922, 1994.
    Liu Z, Stout JE, Tedesco L, Boldin M, Hwang C, Yu VL. Efficacy of 
ultraviolet light in preventing Legionella colonization of a hospital 
water distribution system. Water Res. 29:2275-2280, 1995.
    Liu Z, Stout JE, Boldin M, Rugh J, Diven WR, Yu VL. Intermittent 
use of copper-silver ionization for Legionella control in water 
distribution systems: A potential option in buildings housing low risk 
individuals. Clin Infect Dis 26:138-140; 1998.
    Muraca P, Stout JE, Yu VL. Comparative assessment of chlorine, 
heat, ozone, and ultraviolet light for disinfection of L. pneumophila 
within a model plumbing system. Appl Environ Microbiol 53:447 453, 
1987.
    Muraca PW, Goetz A, Yu VL. Disinfection of water distribution 
systems for Legionella: a review of application procedures and 
methodologies. Infect Control Hosp Epidemiol 11:79-88, 1990.
    Sidari FP, Stout JE, VanBriesen JM, Bowman AM, Grubb D, Neuner A, 
Wagener MM, Yu VL. Chlorine dioxide as a disinfection method for 
Legionella control. J Amer Water Works Assoc. 96: 111-119, 2004
    Stout J, Yu VL, Best M. The ecology of Legionella pneumophila 
within water distribution systems. Appl Environ Microbiol 49;221-228, 
1985.
    Stout J, Yu VL, Muraca P. Isolation of Legionella pneumophila from 
the cold water of hospital ice machines: implications for origin and 
transmission of the organism. Infect Control 6:141-146, 1985.
    Stout J, Best M, Yu VL. Susceptibility of members of the family 
Legionellaceae to thermal stress: implications for heat eradication 
methods in water distribution systems. Appl Environ Microbiol 52:396-
399, 1986.
    Stout JE, Yu VL, Yee YC, Vaccarello S, Diven W, Lee TC. Legionella 
pneumophila in residential water supplies: environmental surveillance 
with clinical assessment for Legionnaires' disease. Epidemiol Infect 
30:537-539, 1992.
    Stout JE, Yu VL, Muraca P, Joly J, Troup N, Tompkins LS. Potable 
water as a cause of sporadic cases of community-acquired Legionnaires' 
disease. N Engl J Med 326:151-155, 1992.
    Stout JE, Lin YE, Goetz AM, Muder RR. Controlling Legionella in 
hospital water systems: experience with the super-heat-and-flush method 
and copper-silver ionization. Infect Control Hosp Epid 19:911-914, 
1998.
    Stout JE, Yu, VL. Experience of the first 16 hospitals using 
copper-silver ionizaton for Legionella control: implications for the 
evaluation of other disinfection modalities. Infection Control Hosp 
Epid. 24(8): 563-568, 2003.
    Ta AC, Stout JE, Yu VL, Wagener MM. Comparison of culture 
methodologies for monitoring Legionella in hospital potable water 
systems and recommendations for standardization. J Clin Microbiol 
33:2118-2123, 1995.
    Vickers RM, Yu VL, Hanna S, Muraca P, Diven W, Carmen N, Taylor F. 
Determinants of L. pneumophila contamination of water distribution 
systems: 15-hospital prospective study. Infect Control 1987; 8:357-363.
    Yu VL, Liu Z, Stout JE, Goetz A. Legionella disinfection of water 
distribution systems: principles, problems, and practice. Infect 
Control Hosp Epidemiol 14:567-570, 1993.
    Yu VL, Stout JE. Legionella anisa and hospital water systems. J 
Infect Chemother 10:133, 2004.
    Zhang R, McCann C, Stout JE, Piesczynski S, Hawks R, Vidic R, Yu 
VL. Safety and efficacy of chlorine dioxide for Legionella control in a 
hospital water system. Infect Control Hosp Epidemiol 28:1009-1012, 
2007.
    Zhang Z, McCann C, Stout JE, Piesczinsky S, Hawks R, Vidic R, Yu 
VL. Prospective study of the efficacy and safety of chlorine dioxide 
for Legionella control in a hospital water system. Infect Control Hosp 
Epidemiol 28;1009-1012, 2007.
    Zhang Z, Stout JE, Yu VL, Vidic R. Effect of pipe corrosion scales 
on chlorine dioxide consumption in drinking water distribution systems. 
Water Res 42:129-136, 2008.
    Zhang R, McCann C, Hanrahan J, Jencson A, Joyce D, Fyffe S, 
Piesczynski S, Hawks R, Stout JE, Yu VL, Vidic V. Legionella control by 
chlorine dioxide in hospital water systems. J Am Water Works Assoc. 
101: 117-127. 2009
Appendix: VA Cases of hospital-acquired Legionnaires' disease
    Hospital-acquired cases
    2012 5
    2011 16
    2010 0
    2009 0
    2008 0
    2007 1
    =====Victor Yu ousted and SPL closed===========
    2006 0
    2005 0
    2004 0
    2003 0
    2002 0
    2001 0
    2000 0
    1999 0
    1998 0
    1997 0
    1996 0
Appendix: Reasons for Dr. Yu's Ouster from the Pittsburgh VA
    The stated reason for Dr. Yu's ouster by the VA was that he 
processed water specimens sent from hospitals or public health agencies 
concerned about Legionnaires' disease after being ordered not to do so 
by the VA following the ill-advised order for closure of the SPL. Dr. 
Yu justified the processing by noting that the processing had already 
been initiated and these institutions relied on the Special Pathogens 
Laboratory (SPL) to assist them in solving an outbreak of a deadly 
disease. He noted the Hobson's Choice in his reply to Mr. Moreland: 
follow his conscience as a physician vs. obey an order that he judged 
to be irrational and unjust. Ironically, one of the hospitals was a 
southwestern VA Medical Center. This VA Medical Center would 
subsequently express their gratitude to Dr. Yu and acknowledged that 
his firing was a result of his assistance in resolving their outbreak 
of Legionnaires' disease.
    After protests from the scientific community, his patients and 
members of Congress, Mr. Moreland asserted that:

    1) Dr. Yu was conducting unapproved research on VA patients
    2) Dr. Yu was providing laboratory testing to non-VA facilities and 
this was inappropriate.
    Both of these assertions were false and documented to be false.

    See website below for overview of closure of the SPL and ouster of 
Dr Victor Yu http://www.legionella.org/vasplhome.asp

    1. Dr. Yu was conducting unapproved research on VA patients.
    This claim was not only untrue but malicious. It is discussed at 
length in the 2008 Congressional Hearing before the Subcommittee on 
Investigations and Oversight, Committee on Science and Technology, 
September 9, 2008. Serial no. 110-120. Biobanking: How the lack of a 
coherent policy allowed the VA to destroy an unreplaceable collection 
of Legionella samples, pages 416, 426-428.
    The summary of the audited research claimed that ``Dr. Yu had 
conducted human subjects research without prior IRB and R&D Committee 
approvals''. The auditor (Barbara Strelec) denied writing this summary. 
However, a sentence that she had written noted that Dr Yu's studies 
were performed prior to HIPAA enactment and thus IRB and R&D approval 
were not required. This important sentence was removed from the 
document submitted to VACO without her knowledge. As the 2008 
Congressional investigation noted, none of the VA administrators 
including Dr. A. Sonel, who signed the document, would admit to 
deleting this sentence.

    2. Dr. Yu was providing laboratory testing to non-VA facilities and 
this was inappropriate.
    See the Link below for a rebuttal of the untrue claims made by 
Michael Moreland in closing the SPL. http://www.legionella.org/vaspl/
spl-FR.htm
    In 1996, the previous administration (Thomas Cappello, Director) 
and Chief, Laboratory Medicine and Pathology (Dr. Gurmukh Singh) 
established the Pittsburgh VA Special Pathogens Laboratory as a Special 
Clinical Resource Center Laboratory (M-2, Part VI, Chapter 11, March 
1994) under VACO Guidelines. The Guidelines explicitly stated that work 
within the private sector was acceptable, since an objective was to 
obtain funds for VA use by exploiting the prestige of select 
laboratories within the VA system. Advertising to the community was 
proposed for this laboratory by the Pittsburgh VA administrators. We 
were instructed by the Pittsburgh VA financial officer (Ray Laughlin) 
that a Memorandum of Understanding or contracts was not required and we 
were instructed to use a fee-for-service system for billing
    (http://www.legionella.org/vaspl/
Attachment%208%20SPLRef%20LabTestingServices1996Memos%20doc.pdf)
    Mr. Moreland testified under oath to my lawyer that had he known of 
this Guideline and approval by the prior Pittsburgh VA Director, he 
would not have closed the SPL. In fact, he was informed of this fact 
prior to closure and copy of the Special Clinical Resource Center 
Laboratory Guidelines had been submitted to an ABI initiated by him.
Appendix: Publications of Legionnaires' disease from Pittsburgh SPL
    PUBLICATIONS ON LEGIONNAIRES' DISEASE FROM INFECTIOUS DISEASE 
SECTION AND SPECIAL PATHOGENS LABORATORY, PITTSBURGH VA MEDICAL CENTER 
AND UNIVERSITY OF PITTSBURGH

    Gorman GW, Yu VL, Brown A, Hall JA, Corcoran K, Martin WT, Morris 
GK, Magnussen MH, Fraser DW. Isolation of Pittsburgh Pneumonia Agent 
from nebulizers used in respiratory therapy. Ann Intern Med 
1980;93:572-573.
    Yu VL, Stout J, Zuravleff J, Brown A. Aspiration of contaminated 
water may be mode of transmission for Legionella pneumophila. Intersci 
Conf Antimicrob Ag Chemother, #297, Chicago, 1981.
    Zuravleff, Yu VL, Rihs J, Shonnard J, Elder E. Sensitivity of 
diagnostic tests for Legionnaires' disease: a reappraisal. Annual 
Meeting of the American Society for Microbiology, C39, Atlanta 1982.
    Cordes LG, Wisenthal AW, Gorman GW, Phair JP, Brown A, Yu VL, 
Magnussen MH, Meyer RD, Wold JS, Shands KN, Fraser DW. Isolation of 
Legionella pneumophila from hospital shower heads. Ann Intern Med 
1981;94:195-197.
    Yu VL. Legionnaires' disease: an epidemiologic overview. JAMA 1981; 
245:2429.
    Zuravleff, Yu VL, Rihs J, Shonnard J, Elder E. Sensitivity of 
diagnostic tests for Legionnaires' disease: a reappraisal. Annual 
Meeting of the American Society for Microbiology, C39, Atlanta 1982.
    Brown A, Yu VL, Magnussen MH, Vickers GM, Garrity RM, Elder EM. 
Isolation of Pittsburgh pneumonia agent from a hospital shower. Appl 
Environ Microbiol 1982;43:725-726.
    Stout J, Yu VL, Vickers RM, Zuravleff J, Best M, Brown A, Yee RB, 
Wadowsky R. The ubiquitousness of Legionella pneumophila in the water 
supply of a hospital with endemic Legionnaires' disease. N Engl J Med 
1982;306:466-468.
    Yu VL, Kroboth FJ, Brown A, Shonnard J, McDearman S, Magnussen MH, 
Elder E. Legionnaires' disease: new clinical perspective from a 
prospective study, Amer J Med 1982;73:357-361.
    Goetz A, Yu VL. Cost-effectiveness of eradication measures directed 
at Legionnaires' disease. Association of Practitioners of Infection 
Control. 10th Annual Educational Conference, #PS-11, San Diego, 1983.
    Yu VL, Zuravleff JJ, Elder EM, Brown A. Pittsburgh pneumonia agent 
may be a common cause of nosocomial pneumonia: seroepidemiologic 
evidence. Ann Intern Med 1982;97:724-725.
    Best M, Yu VL, Stout J, Goetz A, Muder RR, Taylor F. Legionellaceae 
in the hospital water supply: epidemiological link with disease and 
evaluation of a method for control of nosocomial Legionnaires' disease 
and Pittsburgh pneumonia agent. Lancet 1983;2:307-310.
    Kroboth FJ, Yu VL, Reddy S, Yu AC. Clinicoradiographic correlations 
with the extent of Legionnaires' disease. Amer J Roentgen 1983;141:263-
268.
    Muder RR, Yu VL, McClure J, Kroboth FJ, Kominos S, Lumish RM. 
Nosocomial Legionnaires' disease uncovered in a prospective pneumonia 
study: implications for underdiagnosis. JAMA 1983;249:3184-3188.
    Muder RR, Yu VL, Vickers R, Rihs J, Shonnard J. Simultaneous 
infection with Legionella pneumophila and Pittsburgh pneumonia agent -- 
clinical features and epidemiological implications. Amer J Med 
1983;74:609-614.
    Muder RR, Yu VL, Zuravleff JJ. Pneumonia due to the Pittsburgh 
pneumonia agent: new clinical perspective plus a review of the 
literature. Medicine 1983;62:120-128.
    Yu VL, Zuravleff JJ, Gavlik L, Magnussen MH. Lack of evidence for 
person-to-person transmission of Legionnaires' disease. J Infect Dis 
1983;l47:362.
    Zuravleff JJ, Yu VL, Shonnard J, Davis B, Rihs JD. Diagnosis of 
Legionnaires' disease: an update of laboratory methods with new 
emphasis on isolation by culture. JAMA 1983;250:1981-1985.
    Zuravleff JJ, Yu VL, Shonnard J, Rihs J, Best M. Legionella 
pneumophila contamination of a hospital humidifier: demonstration of 
aerosol transmission and subsequent subclinical infections in exposed 
guinea pigs. Amer Rev Respir Dis 1983;128:657-661.
    Muraca PW, Yu VL, Neufeld R, Best M, Stout J. Growth and 
inactivation studies of the Legionnaires' disease bacterium. American 
Water Works Association, Pittsburgh, PA 1984.
    Best M, Goetz A, Yu VL. Heat eradication measures for control of 
nosocomial Legionnaires' disease: implication, education, and cost-
analysis. Amer J Infect Control 1984;12:26-30.
    Muder RR, Reddy S, Yu VL, Kroboth FJ. The radiology of pneumonia 
caused by Pittsburgh pneumonia agent. Radiology 1984;150:633-637.
    Vickers RM, Yu VL. Clinical laboratory differentiation of 
Legionellaceae family members with pigment production and fluorescence 
on media supplemented with aromatic substrates. J Clin Microbiol 
1984;19:583-587.
    Best MG, Stout JE, Yu VL, Muder RR. Tatlockia micdadei growth 
kinetics may explain its infrequent isolation from water and the low 
prevalence of Pittsbugh pneumonia. Appl Environ Microbiol 1985;49:1521-
1522.
    Johnson JT, Yu VL, Best MG, Vickers R, Goetz A, Wagner, R, Wicker 
H, Woo A. Nosocomial Legionellois in surgical patients with head and 
neck cancer: implications for epidemiologic reservoir and mode of 
transmission. Lancet 1985;2:298-300.
    Muder RR, Yu VL. Legionnaires' disease: an emerging problem for 
geriatric patients. Geriatric Med Today 1985; 63-75.
    Rihs JD, Yu VL, Zuravleff JJ, Goetz A, Muder RR. Isolation of 
Legionella pneumophila from blood using the Bactec: a prospective study 
yielding positive results. J Clin Microbiol 1985;22:422-424.
    Stout J, Yu VL, Best M. The ecology of Legionella pneumophila 
within water distribution systems. Appl Environ Microbiol 1985;49:221-
228.
    Stout J, Yu VL, Muraca P. Isolation of Legionella pneumophila from 
the cold water of hospital ice machines: implications for origin and 
transmission of the organism. Infect Control 1985;6:141-146.
    Johnson J, Yu VL, Wagner R, Best M. Nosocomial Legionella pneumonia 
in a population of head and neck cancer patients. Laryngoscope 
1985;95:1468-1471.
    Stout JE, Best M, Yu VL, Rihs JD. Symbiosis of Legionella 
pneumophila and Tatlockia micdadei with human respiratory flora. J Appl 
Bacteriology 1986; 60:297-299.
    Muder RR, Yu VL, Woo AH. Mode of transmission of Legionella 
pneumophila: a critical review. Arch Intern Med 1986; 146:1607-1612.
    Stout J, Best M, Yu VL. Susceptibility of members of the family 
Legionellaceae to thermal stress: implications for heat eradication 
methods in water distribution systems. Appl Environ Microbiol 1986; 
52:396-399.
    Muraca P, Stout J, Yu VL. Comparative assessment of chlorine, heat, 
ozone, and ultraviolet light for killing of Legionella pneumophila 
within a model plumbing system. Appl Environ Microbiol 1987; 53:447-
453.
    Korvick J, Yu VL. Legionnaires' disease -- an emerging surgical 
problem. Ann Thoracic Surg 1987; 43:341-347.
    Korvick J, Yu VL, Fang GD. The role of Legionella sp. in nosocomial 
pneumonia. Semin Respiratory Infections 1987; 2:34-47.
    Stout J, Yu VL, Muraca P. Legionnaires' disease acquired from the 
water supply within the homes of two patients. JAMA 1987; 257:1215-
1217.
    Yu VL, Beam TR, Lumish RM, Vickers RM, Fleming J, McDermott C, 
Romano J. Routine culturing for Legionella in the hospital environment 
may be a good idea: a 3-hospital prospective study. Amer J Med Sci 
1987; 294:97-99.
    Vickers RM, Yu VL, Hanna S, Muraca P, Diven W, Carmen N, Taylor F. 
Determinants of L. pneumophila contamination of water distribution 
systems: 15-hospital prospective study. Infec Control 1987; 8:357-363.
    Brennen C, Vickers RM, Yu VL, Puntereri A, Yee YC. Discovery of 
occult Legionella pneumonia in a long-term care facility. Brit Med J 
1987; 295: 306-307.
    Muder RR, Yu VL, Parry M. Radiology of Legionella pneumonia. Semin 
Resp Infec 1987; 2:242-254.
    Fang GD, Yu VL. Infection caused by Pittsburgh pneumonia agent 
(Tatlockia micdadei, Legionella micdadei). Semin Resp Infec 1987; 
2:262-266.
    Vickers RM, Stout JE, Yu VL, Rihs JD. Culture methodology for the 
isolation of Legionella pneumophila and other Legionellaceae from 
clinical and environmental specimens. Semin Resp Infec 1987; 2:274-279.
    Lee TC, Stout JE, Yu VL. Factors predisposing to L. pneumophila 
colonization in residential water systems. Arch Environ Health 1988; 
43:59-62.
    Stout J, Joly J, Para P, Plouffe J, Ciesielski, Blaser M, Yu VL. 
Comparison of molecular methods for subtyping patient and 
epidemiologically-linked environmental isolates of Legionella 
pneumophila. J Infec Dis 1988; 157:486-495.
    Muraca PW, Stout JE, Yu VL. Environmental aspects of Legionnaires' 
disease. J Amer Water Works Assoc 1988; 80:78-86.
    Fang GD, Yu VL. Diagnosis and treatment of Legionnaires' disease. 
Infec Medicine 1988; 5:27-54.
    Muraca PW, Stout JE, Yu VL, Yee YC. Legionnaires' disease in the 
work environment: implications for environmental health. Am Industr Hyg 
Assoc J 1988; 49:584-590.
    Muder RR, Yu VL, Fang GD. Community acquired Legionnaires' disease. 
Semin Resp Infect 1989; 4:32-39.
    Fang GD, Yu VL, Vickers RM. Disease due to the Legionellaceae 
(other than L. pneumophila): historical, microbiological, clinical and 
epidemiological review. Medicine 1989; 68:116-132.
    Vickers RM, Stout JE, Yu VL. Failure of a diagnostic monoclonal 
immunofluorescent reagent to detect Legionella pneumophila in 
environmental samples. Appl Environ Microbiol 1990; 56:2912-2914.
    Fine J, Orloff JJ, Arisumi D, Fang GD, Arena V, Hanusa B, Yu VL, 
Singer D, Kapoor WN. Prognosis of patients hospitalized with community-
acquired pneumonia: a prospective derivation and validation of a 
mortality risk index. Amer J Med 1990; 88 (5N): 5/1N-7N.
    Fang GD, Stout JE, Yu VL, Goetz A, Rihs JD, Vickers RM. Community-
acquire pneumonia caused by Legionella dumoffii in a patient with hairy 
cell leukemia. Infection 1990; 18:383-385.
    Fang GD, Fine M, Orloff J, Arisumi D, Yu VL, Kapoor W, Grayston T, 
Wang SP, Kohler R, Muder RR, Yee YC, Rihs JD, Vickers RM. New and 
emerging etiologies for community-acquired pneumonia with implications 
for therapy: A prospective multicenter study of 359 cases. Medicine 
1990: 69:307-316.
    Goetz A, Yu VL. Screening for nosocomial legionellosis by culture 
of the water supply and targeting high risk patients for specialized 
laboratory testing. Amer J Infect Control 1991;19:63-66.
    Oliverio MJ, Fisher MA, Vickers RM, Yu VL, Menon A. Diagnosis of 
Legionnaires' disease by radioimmunoassay of Legionella antigen in 
pleural fluid. J Clin Microbiol 1991; 2893-2894.
    Nguyen MH, Stout JE, Yu VL. Legionellosis. Infect Dis Clin N Amer 
1991;5:561-584.
    Swanson DJ, Sung RJ, Fine MJ, Orloff JJ, Chu SY, Yu VL. 
Erythromycin ototoxicity: prospective assessment with serum 
concentrations and audiograms in a study of pneumonia patients. Am J 
Med 1992; 92:61-68.
    Vickers RM, Stout JE, Tompkins LS, Troup NJ, Yu VL. Cefamandole 
susceptibile strains of Legionella pneumophila, serogroup 1: 
implications for diagnosis and utility as an epidemiological marker. J 
Clin Microbiol 1992;537-539.
    Stout JE, Yu VL, Yee YC, Vaccarello S, Diven W, Lee TC. Legionella 
pneumophila in residential water supplies: environmental surveillance 
with clinical assessment for Legionnaires' disease. Epidemiol Infect 
1992;30:537-539.
    Woo AH, Goetz A, Yu VL. Transmission of Legionella by respiratory 
equipment and aerosol generating devices: A review. Chest 1992; 
102:1586-1590.
    Stout JE, Yu VL, Muraca P, Joly J, Troup N, Tompkins LS. Potable 
water as a cause of sporadic cases of community-acquired Legionnaires' 
disease. N Engl J Med 1992; 326:151-155.
    Williams P, Yu VL. Successful use of ciprofloxacin and rifampin for 
treatment of Legionella pneumonia in a heart transplant recipient. 
Transpl Sci 1992; 2:73-74.
    Yu VL. Could aspiration be the major mode of transmission for 
Legionella? Amer J Med 1993; 95:13-15.
    Yu VL. Legionnaires disease: new understanding of community-
acquired pneumonia. Hosp Prac 1993; 28:63-70.
    Singh N, Muder RR, Yu VL, Gayowski T. Legionella infection in liver 
transplant recipients: implications for management. Transplantation 
1993;56:1549-1551.
    Lee TC, Vickers RM. Yu VL, Wagener MM. Growth of 28 Legionella 
species on selective culture media: a comparative study. J Clin 
Microbiol 1993; 31:2764-2768.
    Yu VL, Liu Z, Stout JE, Goetz A. Legionella disinfection of water 
distribution systems: principles, problems, and practice. Infect 
Control Hosp Epidemiol 1993; 14:567-570
    Canadian Community Acquired Pneumonia Consensus Group (Chairmen: 
Mandell LA, Marrie T, Yu VL, Neiderman M). Antimicrobial treatment of 
community acquired pneumonia in adults; a conference report. Canad J 
Infect Dis 1993; 4:25-28.
    Niederman MS, Bass J, Campbell GD, Fein A, Grossman R, Mandell LA, 
Marrie TJ, Sarosi GA, Torres A, Yu VL. Guidelines for the initial 
management of adults with community-acquired pneumonia: diagnosis, 
assessment of severity, and initial antimicrobial therapy. Amer Rev 
Resp Dis 1993;148:1418-1426.
    Mandell LA, Marrie TJ, Niederman MS, Bass J, Chow A, Craven D, 
Finch R, Nicolle L, Sarosi G, Thornsberry C, Wise R, Yu VL. Initital 
antimicrobial treatment of hospital acquired pneumonia in adults: a 
conference report. Canad J Infect Dis 1993; 4:317-321.
    Vickers RM, Yee YC, Rihs JD, Wagener MM, Yu VL. Prospective 
assessment of sensitivity quantitation and timing of urinary antigen, 
serology, and direct fluorescent antibody for diagnosis of 
Legionnaires'disease. 93rd Amer Soc Microbiol, #C17,Las Vegas, 1994.
    Liu Z, Stout JE, Tedesco L, Boldin MM, Hwang CC, Yu VL. Ultraviolet 
light irradiation of potable water for Legionella colonization in a 
hospital water distribution system. ASHRAE Transactions 1994; 100:3751.
    Ta AC, Stout JE, Yu VL, Wagener MM. Comparison of culture 
methodologies for monitoring Legionella in hospital potable water 
systems and recommendations for standardization. J Clin Microbiol 
1995;33:21118-2123.
    Lin YSE, Vidic RD, Stout JE, Yu VL. Individual and combined effects 
of copper and silver and silver ions on inactivation of Legionella 
pneumophila. Water Research 1996;8:1905-1913.
    Chang FY, Jacobs SL, Colodny SM, Stout JL, Yu VL. Nosocomial 
Legionnaires' disease caused by Legionella pneumophila, serogroup 5: 
laboratory and epidemiological infection. J Infect Dis 1996;174:1116-
1119.
    Lin A, Stout JE, Rihs JD, Vickers RM, Yu VL. Improved Legionella 
selective media by addition of fluconazole: results of in vitro testing 
and clinical trial. Amer Soc Microbiol 1997; C-100, Miami Beach.
    Chang FY, Stout JE, Yu VL. Assessment of enzyme immunoassay vs. 
radioimmunoassay for detection of Legionella pneumophila serogroup 1 
antigen in frozen urine specimens. J Clin Microbiol 1996;34:2628-2629.
    Goetz A, Yu VL. Copper-silver ionization: cautious optimism for 
Legionella disinfection
    and implications for environmental culturing. Am J Infect Control 
1997;25:449-451.
    Vergis E, Yu VL. Macrolides are ideal antimicrobial agents for 
empiric therapy of community-acquired pneumonia. Semin Resp Infect 
1997;12:322-328.
    Stout JE, Yu VL. Current concepts: Legionellosis. N Engl J Med 
1997; 337: 682-687.
    Mietzner SM, Stout JE, Yu VL. Prospective study of the effect of 
storage temperatur on the stability of the Legionella pneumophila 
serogroup 1 urinary antigen. 98th Amer Soc Microbiol 1998; C-3, 
Atlanta, GA.
    Liu Z, Stout JE, Boldin M, Rugh J, Diven WF, Yu VL. Intermittent 
use of copper-silver ionization for Legionella control in water 
distribution systems: a potential option in buildings housing low risk 
individuals. Clin Infect Dis 1998;26:138-140.
    Goetz AM, Stout JE, Jacobs SL, Fisher MA, Ponzer RE, Drenning S, Yu 
VL. Nosocomial Legionnaires' disease discovered in community hospitals 
following cultures of the water system: seek and ye shall find. Am J 
Infect Control 1998;26:8-11.
    Stout JE, Arnold B, Yu VL. Comparative activity of ciprofloxacin, 
ofloxacin, levofloxacin, and erythromycin against Legionella species by 
broth microdilution and intracellular susceptibility testing in HL-60 
cells. Diagn Microbiol Infect Dis 1998;30:37-43.
    Stout JE, Arnold B, Yu VL. Activity of azithromycin, 
clarithromycin, roxithromycin against Legionella species by 
intracellular susceptibility testing in HL-60 cells. J Antimicrob 
Chemother 1998;41:289-291.
    Lin YSE, Vidic R, Stout JE, McCartney CA, Yu VL. Inactivation of 
mycobacteriumavium by copper and silver ions. Water Res 1998;32:1997-
2000.
    Chow JW, Yu VL. Legionella: A major opportunistic pathogen in 
transplant recipients. Semin Resp Infect 1998;13:132-139.
    Lin Yu, Stout JE, Yu V, Vidic RD. Disinfection of water 
distribution systems for Legionella. Semin Resp Infect 1998;13:147-159.
    Lin YSE, Vidic RD, Stout JE, Yu VL. Legionella in water 
distribution systems. J Amer Water Works Assoc. 1998;90:112-121.
    Yu VL. Resolving the controversy on environmental cultures for 
Legionella: a modest proposal. Infect Control Hosp Epidemiol 
1998;19:893-897.
    Lin A, Stout JE, Rihs JD, Vickers RM, Yu VL. Improved legionella 
selective media by the addition of fluconazole: results of in vitro 
testing and clinical evaluation. Diagn Microbiol Infect Dis 
1999;34:173-175.
    Yu VL. Nosocomial Legionellosis. Curr Opin Infect Dis 2000;13:385-
388.
    Squier C, Stout JE, Yu VL. Waterborne nosocomial infections. Curr 
Infect Dis Resp 2000; 2:490-496.
    Muder RR, Stout JE, Yu VL. Nosocomial Legionella micdadei infection 
in transplant recipients: fortune favors the prepared mind. Am J Med 
2000;108:346-348.
    Yu VL. Nosocomial legionellosis. Curr Opinion Infect Dis 
2000;13:385-388.
    Drenning DS, Stout JE, Joly JR, Yu VL. Unexpected similarity of 
pulsed-field gel electrophoresis patterns of unrelated clinical 
isolates of Legionella pneumophila serogroup 1. J Infect Dis 
2001;183;628-632.
    Vergis EN, Akbas E, Yu VL. Legionella as a cause of severe 
pneumonia. Sem Resp Crit Care Med 2000;21:295-304.
    Mulazimoglu L, Yu VL. Can Legionnaires' disease be diagnosed by 
clinical criteria? Chest 2001;120:1049-1053.
    Akbas E, Yu VL. Legionnaires' disease and pneumonia. Postgrad Med 
2001; 109:135-147.
    Yu, V.L. Legionella surveillance: political and social implications 
- a little knowledge is a dangerous thing. J Infect Dis 2002; 185:259-
261.
    Stout JE, Yu, VL. Legionella in the hospital water supply: a plea 
for decision making based on evidence-based medicine. Infect Control 
Hosp Epidemiol 2001; 22:670-672.
    Lin YSE, Stout JE, Vidic R, Yu VL. Negative effect of high pH on 
biocidal efficacy of copper and silver ions in controlling Legionella 
pneumophila. Appl Environ Microbiol 2002; 68:2711-2715.
    Sabria M, Yu ML. Hospital-acquired legionellosis: Solutions for a 
preventable infection. Lancet Infect Dis 2002; 2: 368-373.
    Singh N, Stout JE, Yu VL. Source for Legionella infection in 
transplant patients: Implications for prevention. Transplantation 2002; 
74; 755-756.
    Pedro-Botet ML, Stout JE, Yu VL. Legionnaire's disease contracted 
from patient homes: coming of the third plague. Eur J Clin Microbiol 
Infect Dis 2002: 21:699-705.
    Muder RR, Yu VL. Infections due to Legionella species other than L. 
pneumophila. Clin Infect Dis 2002; 35:990-998.
    Yu VL, Plouffe JE, Cstellani-Pastoris M, Stout JE, Schousboe M, 
Widmer A, Summersgill J, File T, Heath CM, Paterson DL, Chereshsky A. 
Distribution of Legionella species and serogroups isolated by culture 
in patients with sporadic community-acquired legionellosis: an 
International Collaborative Survey. J Infect Dis 2002; 186:127-128.
    Stout JE, Yu VL. Experience of the first 16 hospitals using copper-
silver ionization for Legionella control: Implications for the 
evaluation of other disinfection modalities. Infect Control Hosp 
Epidemiol 2003; 82:322-332.
    Marrie TJ, DeCarolis E, Yu VL, Stout Je. Legionnaires' disease - 
results of a multicenter Canadian study. Can J Infect Dis 2003; 14:154-
158.
    Stout JE, Yu VL. Hospital-acquired Legionnaires' disease: new 
developments. Curr Opin Infect Dis 2003; 16:337-341.
    Sidari FP, Stout JE, VanBriesen JM, Bowman AM, Grubb D, Neuner A, 
Wagener MM, Yu VL. Chlorine dioxide as a disinfection method for 
Legionella control. J Amer Water Works Assoc 2004; 96:111-119.
    Yu VL, Greenberg RN, Zadeikis N, Stout JE, Khasab MM, Olson WH, 
Tennenberg AM. Levofloxacin efficacy in the treatment of community-
acquied legionellosis. Chest 2004; 125:2135-2139.
    Yu VL, Stout JE, Singh N. Legionnaires' disease in transplantation: 
a standardized approach for an underdiagnosed opportunistic pathogen. 
Transplant Infect Dis 2004; 6:58-62.
    Yu VL, Stout JE. Legionella anisa and hospital water systems. J 
Infect Chemother 2004; 10:133.
    Stout JE, Sens K, Mietzner S, Obman A, Yu VL. Comparative activity 
of quinolones, macrolides and ketolides against Legionella species 
using in vitro broth dilution and intracellular susceptibility testing. 
Int J Antimicrob Agents 2005; 24:302-307.
    Squier CL, Stout JE, Krystofiak S, et al. A protective approach to 
prevention of health
    care-acquired Legionnaires' disease: the Allegheny County 
(Pittsburgh) experience. Am J Infect Control 2005; 33:360-367.
    Seenivasan MH, Yu VL, Muder RR. Legionnaires' disease in long-term 
care facilities: overview and proposed solutions. J Am Geriatr Soc 
2005; 53:875-880.
    Liu Z, Lin YSE, Stout JE, Huang CC, Vidic R, Yu VL. Effect on flow 
regimes on the
    presence of Legionella within the biofilm of a model plumbing 
system. J Appl Microbiol 2006; 101:437-442.
    Greenberg D, Chiou CC, Famigilieti R, Lee TZ. Problem pathogens: 
paediatraic legionellosis - implications for improved diagnosis. Lancet 
Infect Dis 2006; 6:529-535.
    Pedro-Botet L, Yu VL. Legionella: macrolides or quinolones? Clin 
Microbiol Infect 2006; 12:25-30.
    Stout JE, Muder RR, Mietzner S, Wagener MM, Perri MB, DeRoos K, et 
al. Role of environmental surveillance in determining risk for 
hospital-acquired legionellosis: a national surveillance study with 
clinical correlations. Infect Control Hosp Epidemiol 2007;28:818-824.
    Zhang Z, McCann C, Stout JE, Piesczinsky S, Hawks R, Vidic R, Yu 
VL. Prospective study of the efficacy and safety of chlorine dioxide 
for Legionella control in a hospital water system. Infect Control Hosp 
Epidemiol 2007;28:1009-1012.
    Yu VL. Cooling towers and legionellosis: A conundrum with proposed 
solutions. Int J Hyg Environ Health 2008;211(3-4):229-34.
    Yu VL, Stout JE. Community-acquired Legionnaires' disease: 
Implications for under diagnosis and laboratory testing. Clin Infect 
Dis, 2008:46.
    Pedro-Botet ML, Yu VL. Treatment strategies for Legionella 
infection. Expert Opin Pharmacother 2009;10(7):1109-1021.
    Stout JE, Yu VL. Environmental culturing for Legionella: Can we 
build a better mouse trap. Am J Infect Control 2010;38:341-343.
    Yu VL, Lee TC. Neonatal legionellosis: the tip of the iceberg for 
pediatric hospital-acquired pneumonia? Pediatr Infect Dis J 
2010;29:282-284.
    Lin YE, Stout JE, Yu VL. Controlling Legionella in hospital 
drinking water: an evidence-based review of disinfection methods. 
Infect Control Hosp Epidemiol 2011;32:166-73.
    Lin YE, Stout JE, Yu VL. Prevention of hospital-acquired 
legionellosis. Curr Opin Infect Dis. 2011;24(4):350-6.
    Yu VL, Stout JE. Legionellosis in nursing homes: What the Slovenia 
experience can teach us. Scand J Infect Dis 2012; 44(9):716-719.

    Textbook Chapters

    Yu VL: Legionellosis. In: Cherniack RM, ed. Current Therapy of 
Respiratory Disease, B. C. Decker, 1984.
    Yu VL. Legionellosis. In: Bayless MC, Brain M, Cherniack R, eds. 
Current Therapy in Internal Medicine, C. V. Mosby, 1984.
    Yu VL. Nosocomial Legionellosis: current epidemiologic issues. In: 
Swartz M, Remington J, eds. Current Clinical Topics in Infectious 
Disease, McGraw Hill, 1986.
    Yu VL. Legionellosis. In: Cherniack R, ed. Current Therapy of 
Respiratory Disease, B.C. Decker, 1987.
    Yu VL. Legionellosis. In: Bayless T, Brain M, Cherniak R, eds. 
Current Therapy in Internal Medicine - 2, B.C. Decker, 1987.
    Yu VL. Legionellosis. In: Rakal R, ed. Conn's Current Therapy, W. 
B. Saunders, 1988.
    Yu VL. Legionellosis. In: Schaechter M, ed., Mechanisms of 
Microbial Disease, Williams and Wilkins, 1989.
    Yu VL. Pathophysiology of Legionella infection in the 
immunocompromised host. In: Revillard JP, Wierzbicki N, eds. 
Opportunistic Infections. Fondation Franco-Allemande, France, 1989.
    Yu VL. Infections due to Legionella pneumophila. In: Mandell G, et 
al, ed. Principles and Practice of Infectious Diseases. Churchill-
Livingston, l990.
    Fang GD, Yu VL. Infections due to Legionella species (other than L. 
pneumophila). In: Mandell G, et al, ed. Principles and Practice of 
Infectious Diseases. Churchill-Livingston, 1990.
    Muder RR, Yu VL. Clinical Infection: Legionnaire's disease. In: 
Gorbach S, et al, ed. Infectious Diseases in Medicine and Surgery, W.B. 
Saunders, 1991.
    Yee YC, Yu VL. Microbial agent: Legionella. In: Gorbach S, et al, 
ed. Infectious Diseases in Medicine and Surgery. W.B. Saunders, 1991.
    Yu VL. Legionellosis. In: Rakal R, ed. Conn's Current Therapy, W.B. 
Saunders, 1992.
    Nguyen MLT, Yu VL. Legionella infection. In: Winterbauer R, ed. 
Atypical pneumonia syndromes. Clinics in Chest Medicine, W.B. Saunders, 
Philadelphia, 1991.
    Nguyen M. Hong, Stout YE, Yu VL. Legionellosis. In: Wallace R, ed. 
Lower respiratory infections. Infectious Disease Clinics of North 
America, W.B. Saunders. Philadelphia, 1992.
    Yu VL, Nguyen MLT. Legionnaires' disease: New insights. 
Contemporary Int Med, 1992;4:49-59.
    Yu VL. Legionnaires' disease. World Book Encyclopedia. 1992.
    Yu VL. Legionella infection. In: Neu H, Young LS, Zinner S (eds). 
The New Macrolides, Azalides, and Streptogramins, Marcel Dekker, New 
York, 1993.
    Muder RR, Yu VL. Legionella group of organisms. In: Neiderman M, et 
al, eds. Respiratory Infections, W.B. Saunders, Philadelphia, 1994.
    Stout JE, Yu VL. Legionella pneumophila. In: Chmel H, Bendinelli M, 
Friedman H (eds.). Pulmonary Infections and Immunity. Plenum Press, New 
York, 1994.
    Yu VL, Goetz A. Nosocomial legionellosis. In: Mayhall CG (ed) 
Hospital Epidemiology and Infection Control. Williams and Wilkins, 
1994.
    Yu VL. Infection due to Legionella pneumophila. In: Mandell G, et 
al, eds. Principles and Practice of Infectious Diseases, Churchill-
Livingston, 1994.
    Muder RR, Yu VL. Infections due to Legionella species (other than 
Legionella pneumophila). In: Mandell G, et al, eds. Principles and 
Practice of Infectious Diseases, Churchill-Livingston, 1994.
    Chang FY, Yu VL. Pneumonia. In: Root RK, et al., ed. Clinical 
Infectious Diseases: a Practical Approach. Oxford University Press, 
1996.
    Mulazimaglou L, Yu VL. Legionella. In: Schlossberg D. Current 
Therapy in Internal Medicine, Mosby Yearbook, 1996.41.
    Chang FY, Yu VL. Haemophilus pneumonia. In: Schlossberg D. Current 
Therapy in Internal Medicine. Mosby Yearbook, 1996.
    Goetz A, Yu VL. Legionella. In: APIC and Applied Epidemiology: 
Principles and Practice. Infection Control. Mosby, 1996.
    Vergis E, Yu VL. Pulmonary infections due to Legionella species. 
In. Fishman AP, et al (eds). Fishman's Pulmonary Diseases and 
Disorders, McGraw Hill, 1996.
    Chang FY, Yu VL. Legionella Infections. In: Isselbacher K, et al 
(ed). Harrison's Principles of Internal Medicine. 15th ed. McGraw-Hill, 
2001.
    Mulazimoglu L, Yu VL. Legionella Infections. In: Isselbacher K, et 
al (eds). Harrison's Principles of Internal Medicine, 14th ed. McGraw-
Hill, 1997.
    Paterson DL, Yu VL. Legionellosis: In: Rakal R, ed., Conn's Current 
Therapy, W.B. Saunders, 1999.
    Mulazimoglu L, Yu VL. Legionella. In: Kassirer J, Greene H (Eds), 
Current Therapy in Adult Medicine, Mosby, 1997.
    Invited reviews, book reviews, miscellaneous
    Yu VL. Book review of Infectious Diseases--Diagnosis and 
Management. Edited by T. Yoshikawa. JAMA 245:771, 1981.
    Yu VL. Tap water rinse for invasive equipment may spread 
Legionnaires' disease. Hospital Infection Control 1984; 1:97-98.
    Chow JW, Yu VL. New perspectives on Legionella pneumonia. J Crit 
Ill 1988; 3:17-27.
    Stout JE, Yu VL. Legionnaires' disease and water distribution 
systems. Infect Dis Newsletter 1993; 12:25-28.
    Stout JE, Lin YSE, Yu VL. State of the art in disinfection methods 
for controlling Legionella pneumophila in water systems. Water 
Conditioning Purific. 1997:82-85.
    Stout JE, Yu VL. Eradicating Legionella from hospital water 
(letter). JAMA 1997;278: 1401-1405.
    Yu VL. The growing arsenal of agents Legionnaires' disease. J Crit 
Care 1997;12:338.
Executive Summary
    Victor L. Yu, M.D., Professor of Medicine, University of 
Pittsburgh, Pittsburgh, Pennsylvania
    I was the former Chief of the Infectious Disease Section at the 
Pittsburgh VA Medical CenterI. I received Superior evaluations for 29 
consecutive years. I was also the Chief of the Pathogens Laboratory 
(SPL) - a laboratory initiated under the aegis of VACO during the 
Legionella outbreaks in VA hospitals in the late 1970s. Discoveries 
were made by the VA Special Pathogens Laboratory that brought honor and 
renown to the Pittsburgh VA Medical Center.

      Discovery of the source of hospital-acquired 
Legionnaires' disease was the drinking water of the hospital. In 1982, 
this historic discovery was published in the New England Journal of 
Medicine. It was a controversial article that was not accepted by 
authorities at that time, notably the CDC who favored cooling towers as 
the source.
      Formulation and application of disinfection strategies 
which included : Superheat and Flush, Chlorination, Copper-Silver 
Ionization, Chlorine dioxide, Monochloramine (see Appendix).
      Testing and patient evaluation of new antibiotics 
effective for treating Legionnaires' disease. Azithromycin and 
Levofloxacin decreased the mortality to < 5%.
      Development and testing of the current laboratory 
methodologies including the culture media for patients and water plus 
the evaluation of the urinary antigen test in pneumonia patients.
      Creation of the strategy for prevention of hospital-
acquired Legionnaires' disease that has been adopted by the VA and 
worldwide. Ironically, CDC opposes this strategy which uses 
contamination of drinking water as the key parameter for prevention.

    In 2006, our SPL was abruptly closed. I was fired because I had 
disobeyed an order not to process specimens during my appeal to VACO. 
One set of cultures uncovered an outbreak of Legionnaires' disease. 
This VA later thanked me for processing the cultures knowing that I had 
been fired because I assisted them in their time of need (See 
Appendix). After protests from my patients, the American Legion and 
members of Congress , Mr. Michael Moreland, Hospital Director, informed 
the press and others was that I had conducted unapproved research and 
operated a rogue laboratory for profit. Both of these accusations were 
proven false. (See Appendix)
    The primary issue before you is the deaths of the 5 veteran 
patients. From 1996 to 2006, we saw no cases of hospital-acquired 
Legionnaires' disease. After closure of the SPL, patients began 
contracting Legionnaires' disease after entering the VA. Physicians 
were not warned that Legionella had re-entered the drinking water. 
Attempts to disinfect the re-contaminated water supply were 
unsuccessful for more than one year.
    In Congressional investigations, you have uncovered deficiencies 
and mismanagement by senior VA bureaucrats and you have been frustrated 
by a culture in which maximum effort is given to protecting the 
bureaucrats rather than the veteran patients. Despite a 2008 
congressional investigation and the adverse media publicity, all of the 
bureaucrats s involved in closing the SPL and destroying a valued 
scientific collection were promoted. The VA is an excellent healthcare 
care system but it is tragic that its reputation has been so tarnished.
APPENDIX
    Special Pathogens Laboratory and Disinfection
    VA Cases and hospital-acquired Legionnaires' disease
    First two pages of CV
    Special Clinical Resource Center
    Publications of Legionnaires' disease

                                 
               Prepared Statement of Janet E. Stout, PhD
PURPOSE AND BACKGROUND
    I am testifying today before the House Veterans Affairs 
Subcommittee on Oversight and Investigation to assist in gathering 
information about an outbreak of Legionnaires' disease that occurred at 
the VISN 4 Veterans Health Administration facility at University Drive, 
Pittsburgh, PA. The affected veterans and their families deserve full 
disclosure from the administrators at the University Drive and Heinz 
facilities in Pittsburgh.
    I have been invited to testify today as a subject matter expert on 
Legionnaires' disease. My 30+ years of research in the field of 
Legionnaires' disease provides me with specialized knowledge about 
Legionella bacteria, the methods used to control it in hospital water 
systems and the methods used to investigate possible cases of hospital-
acquired Legionnaires' disease.
    I also have intimate knowledge of the procedures and practices that 
were established at the Pittsburgh VA facilities in response to 
previous outbreaks. I was among the group of scientists that were 
funded by VA Central Office to investigate and study the occurrence of 
Legionnaires' disease at the Pittsburgh VA - the VA facility that is 
the subject of this investigation. I started my studies with the group 
in 1980, the year after the first cases of Legionnaires' disease were 
diagnosed at the Pittsburgh VA. I became part of the VA Special 
Pathogens Laboratory, which was created to study Legionnaires' disease 
and ultimately became a Legionella special reference laboratory.
    Over 100 cases of hospital acquired Legionnaires' disease were 
diagnosed at the Pittsburgh VA in the first years of the outbreak. 
These veterans had come to the VA for routine procedures, but were 
infected with Legionella bacteria from the hospital water system and 
developed a severe form of pneumonia called Legionnaires' disease. The 
mortality rate for hospital-acquired Legionnaires' disease can be as 
high as 30-40%.
    We were the first to definitively demonstrate the link between 
Legionnaires' disease and the presence of Legionella in hospital water 
systems This seminal discovery in 1982 shifted the focus from cooling 
towers to water distributions systems as the primary source for 
Legionnaires' disease.
    I participated in many studies on Legionnaires' disease which were 
conducted in collaboration and under the direction of Dr. Victor Yu, 
Chief of Infectious Diseases and Microbiology at the Pittsburgh VA. 
These studies resulted in seminal findings on identification of the 
source of the bacteria, the treatment of the disease and prevention of 
the disease through disinfection of the hospital hot water system.
    Through these efforts, Legionnaires' disease was controlled at the 
Pittsburgh VA and our findings translated into hundreds of peer-
reviewed papers which helped countless other healthcare and non-
healthcare facilities prevent Legionnaires' disease.
    My work at the Pittsburgh VA Medical Center from the early 1980's 
through 2007 provided me with specific relevant information of the 
processes and procedure we put in place at the Pittsburgh VA to prevent 
hospital-acquired Legionnaires' disease. This includes the methods and 
schedule for monitoring (testing) Legionella and copper and silver 
ions, maintenance of the ionization system, diagnostic and 
microbiological methods used for detecting Legionnaires' disease in 
patients at the Pittsburgh VA, and procedures used to investigate 
possible cases of hospital-acquired Legionnaires' disease.
    In 1981, while at the Pittsburgh VA Medical Center, I was part of 
the team that first demonstrated the link between the presence of 
Legionella bacteria in hospital water systems and the occurrence of 
hospital-acquired Legionnaires' disease. This seminal discovery was 
published in the New England Journal of Medicine in 1982. We went on to 
develop the prevention strategy for hospital-acquired Legionnaires' 
disease which now serves as the model for national guidelines.
    We also developed the diagnostic and microbiological approaches and 
methods used for detecting Legionnaires' disease in patients at the 
Pittsburgh VA, and the procedures used to investigate possible cases of 
hospital-acquired Legionnaires' disease.
QUALIFICATIONS (CV Attached)
    I am a microbiologist trained in clinical and environmental 
microbiology. I received a BS in Biology from Clarion State College, 
Clarion, Pennsylvania; and a Masters and PhD degree in Microbiology 
from the University of Pittsburgh Graduate School of Public Health. I 
am the Director of the Special Pathogens Laboratory in Pittsburgh, PA 
and concurrently a Research Associate Professor in the Department of 
Civil and Environmental Engineering University of Pittsburgh.
    My research and academic studies on Legionella-the bacteria the 
causes Legionnaires' disease have received international recognition. 
As an invited speaker to international and national scientific and 
professional organizations, including the International Symposium on 
Legionella and Legionnaires ' disease, I lecture worldwide on the 
subject of Legionnaires' disease. I serve as a subject matter expert in 
legal cases dealing with Legionnaires' disease, and am a member of 
national societies such as the American Society for Microbiology, the 
Association for Professionals in Infection Control, the Cooling 
Technology Institute, and the America Society of Heating, Refrigerating 
and Air-conditioning Engineers (ASHRAE), in which I a member of the 
ASHRAE Legionella Standards and guideline committees. My expertise 
includes disinfection and control strategies for the prevention of 
Legionnaires' disease and other waterborne pathogens.
    My research on Legionnaires' disease in water systems of homes, 
buildings, hospitals, hotels and utility water systems has been 
reported in over 100 articles published in medical and scientific peer-
reviewed journals. I co-authored the ``Legionella'' chapter published 
in Hospital Epidemiology and Infection Control and the Manual of 
Clinical Microbiology. Currently, I serve as a reviewer on the 
editorial board of Infection Control and Hospital Epidemiology, the 
International Journal of Environmental Health, the Journal of Clinical 
Microbiology, and Water Research.
OUTBREAK OF HOSPITAL- ACQUIRED LEGIONNAIRES' DISEASE AT THE PITTSBURGH 
        VETERANS HEALTHCARE SYSTEM UNIVERSITY DRIVE (VAHS-UD)
    The focus of this investigation should be:

    1.The failure of the Pittsburgh VA to recognize they had an 
outbreak and take preventive actions. We now know there were 16 cases 
and 5 deaths. The delay in recognizing the outbreak may have 
contributed to additional cases and deaths.
    2.The failure of the VA lab to detect Legionella in the water 
system of the VA University Drive. This likely contributed to the delay 
in detecting the outbreak. This failure was due to lack of knowledge 
and experience - a problem brought to the attention of the VA Inspector 
General in 2009.
    3.Failure of the VA to operate and manage the copper-silver 
ionization disinfection system.
    4.Failure to communicate with physicians, staff, patients and 
families regarding the increase in cases of hospital-acquired 
Legionnaires' disease. The delay in alerting physicians may have 
contributed to additional morbidity and mortality.

    Legionnaires' disease Reported: On November 16, 2012, the 
Pittsburgh VAHS-UD reported that it had an outbreak of Legionnaires' 
disease and would ultimately report that 5 cases of hospital-acquired 
Legionnaires' disease had been diagnosed at the University Drive 
facility. One of these five patients died. In a latter report the VA 
disclosed that 16 cases of Legionnaires' disease had been diagnosed at 
the facility in 2011, but these cases were described as having been 
acquired prior to admission to the UD facility, i.e. were community 
acquired.
    In setting the bar for prevention of Legionnaires' disease, the 
Pittsburgh VA cannot be compared to what is done at other facilities, 
but should be judged only by whether they followed their own policies 
and procedures.
MONITORING FOR LEGIONELLA
    Methods: We established the methods used to test for Legionella in 
water systems, including developing the culture media used to isolate 
Legionella. For many years I collected the samples (swabs and water) 
and processed them in the Special Pathogens Laboratory. This task was 
ultimately taken over by other members of the Special Pathogens 
Laboratory. A minimum of 10 outlets and water from the hot water tanks 
were regularly tested as part of the infection control policy for 
Legionnaires' disease prevention.
    When a case of Legionnaires' disease was diagnosed at the 
Pittsburgh VA, we tested the water outlets that the patient may have 
been exposed to, including the faucets and showers in their immediate 
environment.
    Frequency of Testing: When we began testing for Legionella in the 
water supply at the Pittsburgh VA in 1981, the frequency of testing was 
monthly. After the ionization system was installed in 1994, the 
frequency of testing was reduced to every other month. This frequency 
was derived from studies that showed that an interruption in ion 
generation would result in growth of Legionella within 8- 12 weeks 
(Liu-98). Therefore we were uncomfortable with extending the frequency 
of testing beyond the every other month schedule. When I left the 
Pittsburgh VA in 2007, testing for Legionella was conducted every other 
month.
    The Pittsburgh VA microbiology laboratory failed to detect 
Legionella during routine testing and were using out of date methods. 
However, the Pittsburgh VA microbiology laboratory is listed as a CDC 
certified laboratory for Legionella environmental testing - 
successfully participating in the CDC Environmental Legionella 
Isolation Techniques Evaluation (ELITE). Obviously a CDC ELITE 
certification does not guarantee that a laboratory is knowledgeable and 
experienced enough to give reliable results. This failure was due to 
lack of knowledge and experience of the technicians doing the testing - 
a problem brought to the attention of the VA Inspector General in 2009 
(case number 2000-01219-HL-0293).
UNANSWERED QUESTIONS:
    1. How was it determined that the 16 cases of Legionnaires' disease 
diagnosed in were not hospital-acquired and who made this 
determination?

    2. Following the diagnosis of Legionnaires' disease in all of these 
patients, was Legionella testing performed on water outlets (faucets 
and showers) in the immediate vicinity of each of these patients - a 
practice that was instituted during my tenure at the Pittsburgh VA?

    3. What was the schedule for Legionella testing at the University 
Drive VA?

    4. What were the results of routine Legionella testing for 2011 and 
2012 at the University Drive and Heinz campuses?

    5. Were these results discussed at the Infection Control Committee 
and are the minutes of the committee meetings for 2011 and 2012 
available for review?

    6. Why does the current (2011) Pittsburgh VA Infection Control 
Policy (MCM IC-001) stipulate retention of Legionella testing for a 
minimum of 1 year?
THE COPPER-SILVER IONIZATION SYSTEM
    Water System Disinfection: The press release from the Pittsburgh VA 
stated that the disinfection system copper-silver ionization system 
``may not be as effective as previously thought''. This statement seems 
to attempt to shift the responsibility for the outbreak to the 
technology. Subsequent statements from VA Healthcare officials have 
also suggested that the original installation of the ionizations system 
in 1994 was not scientifically based.
    Heat & flush thermal disinfection was used at the Pittsburgh VA 
from 1981 to 1994. The difficulty in performing heat & flush 
eradication procedures, as well as the propensity for Legionella to 
recolonize months after the procedure, led us to seek alternative 
disinfection approaches. Starting the early 1980's, the Special 
Pathogens Laboratory, in conjunction with the University of Pittsburgh 
Department of Environmental Engineering, formulated and devised 
innovative approaches to disinfection and evaluated their efficacy in 
hospitals. All the methods in use today were first evaluated in 
controlled studies by SPL. These included heat and flush, 
hyperchlorination, ultraviolet (UV) light, copper-silver, chlorine 
dioxide and monochloramine.
Efficacy of Copper-silver Ionization:
    This disinfection system was installed at the Pittsburgh VA Medical 
Center in 1994 after results from laboratory studies and field studies 
in other hospitals showed efficacy in controlling (killing) Legionella 
bacteria. The first hospital to install ionization in Pittsburgh Mercy 
Hospital, not the Pittsburgh VA. It was 1994 when an ionization system 
was installed at the Pittsburgh VA .
    Compared to thermal heat & flush, ionization was found to be more 
effective in controlling Legionella environmental positivity and 
occurrence of cases. Following the use of heat & flush (from 1981 to 
1994) and after 4 years of use of copper silver ionization (from 1994 
to 1998) there was a significant reduction in environmental Legionella 
positivity (Stout 98). Our prospective studies showed ionization was 
more effective than thermal methods (Heat & Flush) in reducing both 
environmental positivity and the incidence of Legionnaires' disease at 
the Pittsburgh VA.
    By 2005, among 48 healthcare facilities in Western Pennsylvania, 
85% of hospitals with Legionella in their water systems had initiated 
disinfection and 29% had used a copper-silver ionization system (Squier 
2005). Nationally, by 2001 nearly 300 healthcare facilities had 
installed ionization.
    Not relying solely on our own experience, we conducted a survey of 
16 hospitals also using ionization located in cities across the U.S. 
These 16 hospitals were surveyed twice, once in 1995 and again in 2000. 
The results showed that ionization was also highly effective in 
preventing hospital-acquired Legionnaires' disease in these 16 
hospitals (Stout ICHE 2003). These hospitals had had ionization in 
place for 5 to 11 years. This study represented the final step in a 
proposed 4-step evaluation process of disinfection systems. At the time 
of this publication (2003), a further reduction in Legionella 
environmental positivity and hospital-acquired cases was seen at the 
Pittsburgh VA Medical Center. It was noted in this publication that 
zero (0) cases of hospital acquired Legionnaires' disease occurred at 
the Pittsburgh VA Medical Center from 1999 to 2002 (the date of the 
report submission). This trend continued until the cluster (outbreak) 
of Legionnaires' disease which seems to have occurred at the Pittsburgh 
VA Healthcare system (University Drive and Heinze) in 2011 and 2012.
MONITORING AND MAINTENANCE OF THE COPPER - SILVER SYSTEM AT THE 
        PITTSBURGH VA HEALTHCARE SYSTEM - UNIVERSITY DRIVE
    Methods and Schedule: I established the program for monitoring the 
ionization system at the Pittsburgh VA. In the September 1999 
Pittsburgh VA policy (Memorandum IC-1 entitled ``Copper-silver 
Ionization System Maintenance and Monitoring'') copper testing by a kit 
was to be performed by engineering weekly and silver (+ copper) 
monitored by an analytical test laboratory monthly. Sometime later, 
water samples for laboratory-based testing for copper and silver ions 
was performed on water samples collected on the same schedule as the 
routine Legionella testing - every other month. This testing was 
performed in the Special Pathogens Laboratory by atomic absorption 
spectroscopy (AA). Weekly testing for copper was done by the VA 
plumbers (Facilities Management Service) using a hand held device 
colorimetric test. In the 1999, 2007 and 2011Infection Control 
policies, the suggested target levels for copper was 0.2 - 0.8 mg/L 
(ppm) and for silver 0.02 - 0.08 mg/L (ppm).
    Maintenance of the ionization system was performed by the plumbers 
on a routine basis, generally monthly to quarterly depending on the 
condition of the electrodes.
    At the time of the 2012 outbreak, reports from the ionization 
manufacturers (LiquiTech and Enrich Tarn-Pure) indicated that the 
copper and silver monitoring, when performed, did not meet the 
suggested frequency for testing or the target levels. Documentation of 
this condition began as early as the spring of 2012. In addition, at 
the request of CDC, the Pittsburgh Water and Sewer Authority performed 
copper and silver testing on 11 samples in mid-November and found the 
levels to be ``low''.
UNANSWERED QUESTIONS
    1. Can the VA Healthcare System (University Drive and Heinz) 
produce the records of regular documentation of the amperage and 
voltage of the ionization systems in 2011 and 2012?

    2. What was the schedule for copper and silver ion monitoring, both 
in-house and by the external analytical laboratory in 2011 and 2012?

    3. When was that schedule established?

    4. What were the results of this testing for all tests performed in 
2011 and 2012?

    5. If results were not adequate (meeting their own internal 
standards), what corrective actions were taken to remedy the situation?

    6. As stipulated in the Pittsburgh policy, were problems reported 
to Infection Control in a timely fashion?
CASES OF LEGIONNAIRES' DISEASE AT THE PITTSBURGH VA HEALTHCARE SYSTEM 
        UNIVERSITY DRIVE AND HEINZ FACILITY
    As stated above and reported in peer-reviewed publications, the use 
of copper-silver ionization for controlling Legionella in the water 
system of the Pittsburgh VA facilities had been effective in reducing/
eliminating hospital-acquired Legionnaires' disease. The Pittsburgh VA 
Healthcare System administration reported 5 confirmed cases of 
hospital-acquired Legionnaires' disease acquired from exposure to 
Legionella from the hospital water system in 2012. They later reported 
that 16 cases were diagnosed in 2011, but whether they were hospital-
acquired or had the disease on admission could not be determined.
    The Pittsburgh VA Healthcare System administration appears to have 
been aware of a problem with Legionnaires' disease at their facilities 
well before the November 16th media release reporting the outbreak. 
There were meetings with the Allegheny County Health Department. 
Strains of Legionella recovered from sick veterans seen at the 
University Drive facility were sent to the Centers for Disease Control 
and Prevention for analysis before November 1st.
    The CDC guidelines state that an investigation is required if 2 
cases of probable hospital-acquired Legionnaires' disease are 
identified within a 6 month period? Did the Pittsburgh VA conduct such 
an investigation in 2011 after identifying 2 cases?
UNANSWERED QUESTIONS
    1. What was the date of admission, date of onset of symptoms and 
date of diagnosis for all cases of Legionnaires' disease diagnosed at 
the Pittsburgh VA Healthcare System (University Drive and Heinz) for 
2011 and 2012?

    2. Who made the determination and what were the criteria used to 
conclude that the 16 cases of Legionnaires' disease diagnosed in 2011 
were acquired prior to admission in the community and were not acquired 
at the Pittsburgh VA University Drive or Heinz facilities?

    3. What was the result of analysis by CDC of the Legionella strains 
taken from VA patients and compared to the Legionella from the water 
systems of the University Drive VA and Heinz facility?

    4. Were these strains compared to historical strains from other 
cases of hospital-acquired Legionnaires' disease diagnosed at the 
Pittsburgh VA Healthcare System (University Drive and Heinz) and 
historical water system strains?

    5. The Special Pathogens Laboratory had a collection of thousands 
of Legionella strains from the patients and water at Pittsburgh VA 
Healthcare System dating back to 1979. Unfortunately, administrators at 
the Pittsburgh VA Healthcare System destroyed this collection in 2006 
without approval from the Research Compliance Office and on the day 
that I was to meet with a representative of the Research office to 
transfer the collection to the University of Pittsburgh.

    From 1981 to 2006 the Pittsburgh VA had a Legionella special 
reference laboratory - the Special Pathogens Laboratory that 
successfully controlled Legionella. The microbiologists in this 
laboratory had more than 50 years of experience in Legionnaires' 
disease. As part of our Legionella management program, we coordinated 
and communicated effectively with infection control and engineering to 
insure patient safety. This laboratory also housed a collection of 
thousands of Legionella strains from the patients and water at 
Pittsburgh VA Healthcare System dating back to 1979. Unfortunately, 
administrators at the Pittsburgh VA Healthcare System closed the 
laboratory and destroyed this collection in 2006 without approval from 
the Research Compliance Office and on the day that I was to transfer 
the collection to the University of Pittsburgh.
    A congressional hearing on the matter was conducted in 2008 by the 
Subcommittee on Investigations and Oversight, Committee on Science and 
Technology. The proceedings were published and entitled ``Biobanking: 
How the Lack of a Coherent Policy Allowed the Veterans Administration 
to Destroy an Irreplacable Collection of Legionlla Samples''. The 
committee found no credible rationale for the destruction of this 
collection and closure of the Special Pathogens Laboratory. The 
Chairman of the Subcommittee, Congressman Brad Miller warned that 
``there was something terribly wrong with the management at the 
Pittsburgh VA'' . I expressed concern about the VA microbiology and 
their lack of knowledge and experience - a problem brought to the 
attention of the VA Inspector General in 2009 (case number 2000-01219-
HL-0293). Dr. Yu forecasted in 2008 when he said ``By doing this, 
they've hurt the entire VA system and its patients,'' Incredibly no one 
was held accountable and there were no consequences for closing the lab 
and destroying the microbes.
    Here we are again 5 years later; unfortunately, people died this 
time, not just microbes.

    Recommendations:

    1.The Pittsburgh VA microbiology laboratory failed to detect 
Legionella in environmental samples due to inexperience, lack of 
knowledge and use of outdated methods. They perform testing for other 
VA facilities across the U.S. The Pittsburgh VA microbiology laboratory 
should discontinue offering Legionella testing services to other VA 
medical centers and should notify those facilities that the results of 
that testing may be inaccurate.

    2.The Pittsburgh VA microbiology laboratory is listed as a CDC 
certified laboratory for Legionella environmental testing - 
successfully participating in the CDC Environmental Legionella 
Isolation Techniques Evaluation (ELITE). Obviously a CDC ELITE 
certification does not guarantee that a laboratory is knowledgeable and 
experienced enough to give reliable results. The CDC should revisit 
their certification qualifications to address this weakness in the 
program. They should require laboratories to participate in another 
external proficiency program such as the European Health Protection 
Agency Legionella External Quality Assessment for Legionella Isolation 
from Water Samples.

    3.The CDC is invited to assist facilities in dealing with 
outbreaks. As a guest, their recommendations will not assign 
responsibility, but will merely suggest changes in policy. It will be 
the role of this committee to hold people in administration accountable 
for the failures that led to this outbreak - both past and present. 
They are management failures, not the failures of the front line 
worker. Accountability needs to be from the top down, not the bottom 
up.

    4.The VA Legionella Directive and public health policies should not 
be rewritten due to the management failures at this facility. It was 
the responsibility of the Pittsburgh VA to be current in knowledge and 
vigilant in following the policies and procedures that were already in 
place. The system is not broken, so don't fix it.

    5.The VA management owes an apology to the physicians, staff, 
patients and families regarding the delay in informing them in a timely 
manner about the concerns that there was an increase in cases and that 
an outbreak of Legionnaires' disease was suspected.

    Disclosure: I am the Director of the new Special Pathogens 
Laboratory, Pittsburgh, PA. We provide Legionella testing services to 
VA hospitals across the U.S.
Executive Summary
    When it comes to Legionnaires' disease, the Pittsburgh VA is 
unique. From 1980-2006, the Pittsburgh VA was recognized as the leader 
in Legionella research, a model for control and prevention, and 
provided Legionella services for VAs nationwide. Unfortunately, in 
2012, veterans have now died from a wholly preventable disease.
    The Pittsburgh VA identified the cause of the outbreak on November 
16 stating that the disinfection system copper-silver ionization 
system, ``may not be as effective as previously thought.'' However, 
this explanation is inadequate and raises more questions regarding 
monitoring and maintenance required for efficacy.
    As a microbiologist and former director of the Special Pathogens 
Laboratory housed at the Pittsburgh VA from the 1980s through 2007, I 
established the program for monitoring the ionization system at the 
Pittsburgh VA. From 1997 - 2006, no cases of hospital-acquired occurred 
at the facility using this same technology. It is my understanding that 
this trend continued until the cluster (outbreak) of Legionnaires' 
disease, which seems to have occurred at the Pittsburgh VA Healthcare 
system (University Drive and Heinz) in 2011 and 2012.
    Based on 30 years of expertise in Legionnaires' disease and 
intimate knowledge of Legionella control and prevention at the 
Pittsburgh VA, it is my suspicion that adequate Legionella testing of 
the water and adequate monitoring for ionization levels weren't 
conducted. At the time of the 2012 outbreak, reports from the 
ionization manufacturers indicated that the copper and silver 
monitoring, when performed, did not meet the suggested frequency for 
testing or target levels and that documentation of this condition began 
as early as the spring of 2012.
    My research at the Pittsburgh VA Medical Center from the early 
1980s through 2007 provides me with specific relevant information of 
the processes and procedures in place at the Pittsburgh VA to prevent 
hospital-acquired Legionnaires' disease. This includes the methods and 
schedule for monitoring (testing) Legionella and copper and silver 
ions, maintenance of the ionization system, diagnostic and 
microbiological methods used for detecting Legionnaires' disease in 
patients at the Pittsburgh VA, and procedures used to investigate 
possible cases of hospital-acquired Legionnaires' disease.
    Through these efforts, Legionnaires' disease was essentially 
eliminated at the Pittsburgh VA and our findings translated into 
hundreds of peer-reviewed papers which helped countless other 
healthcare and non-healthcare facilities prevent Legionnaires' disease. 
The Pittsburgh VA had the expertise that others went to for help and 
set the highest standard for prevention. Unfortunately, in 2006, VA 
officials determined that Legionnaires' disease was no longer a 
priority and closed the lab suddenly ending the nation's most 
prestigious program and research for Legionnaires' disease.
    The focus of this investigation should be:

    1.The failure of the Pittsburgh VA to recognize they had an 
outbreak and take preventive actions. We now know there were 16 cases 
and 5 deaths. The delay in recognizing the outbreak may have 
contributed to additional cases and deaths.

    2.The failure of the VA lab to detect Legionella in the water 
system of the VA University Drive. This likely contributed to the delay 
in detecting the outbreak. This failure was due to lack of knowledge 
and experience - a problem brought to the attention of the VA Inspector 
General in 2009.

    3.Failure of the VA to operate and manage the copper-silver 
ionization disinfection system.

    4.Failure to communicate with physicians, staff, patients and 
families regarding the increase in cases of hospital-acquired 
Legionnaires' disease. The delay in alerting physicians may have 
contributed to additional morbidity and mortality.

Recommendations:
    1.The Pittsburgh VA microbiology laboratory failed to detect 
Legionella in environmental samples due to inexperience, lack of 
knowledge and use of outdated methods. They perform testing for other 
VA facilities across the U.S. The Pittsburgh VA microbiology laboratory 
should discontinue offering Legionella testing services to other VA 
medical centers and should notify those facilities that the results of 
that testing may be inaccurate.

    2.The Pittsburgh VA microbiology laboratory is listed as a CDC 
certified laboratory for Legionella environmental testing - 
successfully participating in the CDC Environmental Legionella 
Isolation Techniques Evaluation (ELITE). Obviously a CDC ELITE 
certification does not guarantee that a laboratory is knowledgeable and 
experienced enough to give reliable results. The CDC should revisit 
their certification qualifications to address this weakness in the 
program. They should require laboratories to participate in another 
external proficiency program such as the European Health Protection 
Agency Legionella External Quality Assessment for Legionella Isolation 
from Water Samples.

    3.The CDC is invited to assist facilities in dealing with 
outbreaks. As a guest, their recommendations will not assign 
responsibility, but will merely suggest changes in policy. It will be 
the role of this committee to hold people in administration accountable 
for the failures that led to this outbreak - both past and present. 
They are management failures, not the failures of the front line 
worker. Accountability needs to be from the top down, not the bottom 
up.

    4.The VA Legionella Directive and public health policies should not 
be rewritten due to the management failures at this facility. It was 
the responsibility of the Pittsburgh VA to be current in knowledge and 
vigilant in following the policies and procedures that were already in 
place. The system is not broken, so don't fix it.

    5.The VA management owes an apology to the physicians, staff, 
patients and families regarding the delay in informing them in a timely 
manner about the concerns that there was an increase in cases and that 
an outbreak of Legionnaires' disease was suspected.

    Disclosure: I am the Director of the new Special Pathogens 
Laboratory, Pittsburgh, PA. We provide Legionella testing services to 
VA hospitals across the U.S.
    It is my hope that these hearings will underscore the need for a 
stronger commitment by the VA to protect veterans from a disease that 
should have never happened, especially at the Pittsburgh VA.

                                 
                  Prepared Statement of Aaron Marshall
    Mr. Chairman and Committee Members, thank you for inviting me to 
testify at this hearing today. My name is Aaron Marshall and I am 
Operations Manager for Enrich Products. Enrich supplies copper-silver 
ionization systems for the control of Legionella in potable water 
systems. I am also a veteran of the US Army having served honorably for 
just over four years. My father, also a veteran, received exceptional 
medical care from the Pittsburgh VA Health System for many years. 
Currently he receives the same exceptional care in the West Virginia VA 
Health System.
    The intent of my testimony is to provide information that will 
contribute to a better understanding of what transpired at the VA 
University Drive Campus in Pittsburgh and to provide supporting 
evidence that copper silver ionization, when applied properly, is an 
effective method for controlling Legionella in potable hot water 
systems.
    There are two ways copper-silver ionization systems can be 
implemented. The first is a proactive course and the second is a 
reactive course.
    In a proactive course, a copper-silver ionization system is 
installed as a preventative measure. In these facilities there is no 
confirmed case(s) of Legionnaires' disease or Legionellosis. The 
facility may not even test for Legionella.
    In a reactive course, a facility either has confirmed the presence 
of Legionella in the water through testing, or the facility's potable 
water system is suspected or implicated as the source of Legionnaires' 
disease or Legionellosis cases; in response, a copper silver ionization 
system is installed (temporarily or permanently). Once the desired 
results are achieved through the reactive course, the equipment is 
either removed or continues to operate and the course is transitioned 
to the proactive regimen.
    The differences between the two rest in the course of actions 
recommended and they are significant:
    In the proactive course, lab monitoring for copper and silver ions 
is recommended monthly, flushing of non-used fixtures is recommended 
monthly and Legionella testing may or may not happen.
    In the reactive course, lab monitoring for copper and silver ions 
is performed weekly, the facility institutes a controlled flushing 
program such that all fixtures are flushed weekly, and Legionella 
testing at day 15 and day 30 is conducted to determine the course's 
effectiveness.
    This reactive course has been successfully implemented at numerous 
facilities including The Cleveland VA Medical Center, as well as 
facilities in Pennsylvania, Florida, New York State, North Carolina, 
and Illinois.
    I am here today because in June of 2012, at the request of the 
Pittsburgh VA, I was called in to perform a review of the copper-silver 
ionization system (and its operation) at their facility located on 
University Drive in the Pittsburgh neighborhood of Oakland (sometimes 
referred to as the VA Oakland facility). I was asked to make 
recommendations that would help to improve the functioning of their 
existing LiquiTech equipment. LiquiTech is another supplier of copper-
silver ionization equipment.
    Before submitting my general recommendation report on July 6, 2012, 
I visited the VA University Drive Campus facility three times. The 
dates were June 4th, June 21st and July 2nd. There was no charge to the 
VA for these visits or my report.
    During my visits I personally viewed the four different locations 
where the LiquiTech copper-silver systems were installed. I was 
provided access to the site records from January 2012 until the end of 
June 2012, and the lab copper-silver data from June 2011 through July 
2012. I requested but was denied access to view the Legionella test 
results.
    During two of the three visits, I had separate meetings with 
Infection Control and Engineering / Maintenance personnel.
    The two meetings covered similar topics. The major topics were: 
system maintenance, frequency for monitoring copper-silver ion levels, 
and criteria to determine site test locations. In each of the two 
meetings I covered Enrich recommendations for the routine course and 
reactive course as described earlier.
    Had Enrich Products been aware of the presence of Legionella or 
Legionellosis cases at the VA University Drive Campus, we would have 
recommended implementing the reactive course immediately.
    Sometime in November of 2012, Enrich learned through the media that 
in fact, there were reported cases of Legionnaires Disease at the VA 
University Drive Campus and that there were deaths as a result. In 
addition to the reporting of the outbreak, the media, through quotes 
from the CDC and others, offered doubt on the efficacy of copper silver 
ionization.
    Copper silver ionization is an effective method of controlling 
Legionella bacteria. However, in order to maintain its efficacy, the 
installed system needs to be properly maintained and regularly 
monitored.
    Another important note is that in order to definitively know where 
the source is, testing must be conducted. Often it is assumed 
(automatically) that the source must be the hot water system in a 
facility; we have found a number of times that sources were ice 
machines or decorative water features in the facility.
Conclusion:
    During the short time that Enrich worked with the VA University 
Drive Campus, through today, the VA has not shared its Legionella 
testing data or results.
    If the investigation concludes that the potable hot water system 
was the source of the outbreak , there is no question that regular 
testing could have detected the presence of the bacteria and that the 
reactive course of actions would have been implemented immediately 
minimizing the risk of outbreak.
    We hope to have the opportunity to work with the Department of 
Veterans Affairs in the future in an effort to reduce this risk at all 
of their facilities.
    We also hope to establish a dialogue with the CDC where we can 
share data and information demonstrating the ``real world experiences'' 
of copper silver ionization's effectiveness in treating Legionella in 
facilities throughout the country.
    Thank you for your attention.

                                 
                   Prepared Statement of Steve Schira
    I would like to thank the Subcommittee; we appreciate the 
opportunity to share what we know, to ensure the truth gets told and 
most importantly to work together to see that preventable outbreaks of 
Legionella do not occur in the future.
    I think it is important to state that we consider Veterans 
Administration a proactive organization in regard to its efforts to 
prevent Legionnaires Disease. In 2008, the VA issued a directive to 
assess and address Legionella in their facilities water system.
    Unfortunately, during our interaction with the Oakland VA 
Pittsburgh, it was obvious the VA was not performing the maintenance 
essential to keeping the copper silver ionization systems effective. 
The lack of regulation and oversight also plays an important role here. 
Without anyone checking to make sure they are maintaining a safe water 
environment, this important area of patient safety is the proverbial, 
``out of sight, out of mind'' and all too often gets set aside for 
seemingly higher priority issues.
    In December of 2011, LiquiTech provided a courtesy site visit to 
the Pittsburgh Oakland VA in an effort to reengage the hospital. Prior 
to this visit LiquiTech did not have any performance data, the VA was 
not sharing any copper silver levels, or legionella results. This lack 
of communication, partnership and most importantly validating data, is 
a big red flag and cause of concern.
    While a walkthrough of the facility found obvious evidence that 
there were maintenance shortcomings, multiple people at the VA 
acknowledged and understood that adequate maintenance was not being 
performed. This also resulted in the first disclosure that the VA was 
experiencing low levels of Legionella. Additionally, Mr. Goetz brought 
up that there was an area of the hospital that was left untreated, 
seemingly because of plumbing renovations that needed to be corrected. 
The VA staff in attendance, Mr. Rodney Goetz, Patty Harris and Dr. 
Muder was supportive of the need for maintenance improvements. They 
requested proposals for service and support what would help solve the 
issues they were having. The sentiment we took away from this meeting 
was that the VA was going to take action to correct the maintenance 
problems.
    LiquiTech provided a second courtesy site visit in April of 2012. 
During this visit LiquiTech service engineers found that no maintenance 
activities were being performed. The explanation given was that the 
gentleman put in charge of the systems was out on disability leave. 
Three LiquiTech representatives also encountered a VA staff member 
falsifying copper levels.
    After these visits, a LiquiTech account manager made multiple 
attempts to follow up on the proposals provided and follow through on 
the issues encountered to no avail.
    While LiquiTech has improved its technology and services to include 
remote monitoring and control, in an effort to prevent occurrences such 
as this, clearly the VA could have prevented the Legionella problem 
itself with simple maintenance. Had routine maintenance been preformed, 
had more decisive action been taken by the VA and had the VA 
communicated or requested help this outbreak could have been avoided.
    In our opinion, there needs to be better measures in place to 
ensure that any disinfection method is being maintained with sufficient 
third party CDC elite validation that Legionella is not present.

                                 
                  Prepared Statement of Kathleen Dahl
    Chairman Coffman, Ranking Member Kirkpatrick and Members of the 
Subcommittee.
    Thank you for the opportunity to testify before the Subcommittee on 
the critical issues surrounding the Legionnaire's Disease outbreak at 
my facility, the Pittsburgh VA Healthcare System. I hope my testimony 
will assist the Subcommittee in its efforts to ensure that patients and 
workers are adequately protected from Legionnaires going forward.
    As President of AFGE Local 2028, I represent approximately 2,500 
non-management employees at the University Drive (UD) and Heinz 
facilities representing a wide range of positions. These include 
plumbers, engineers, physicians and nurses, and support personnel 
making patient appointments and working in medical labs among other 
functions.
    As a union President, it is my duty and privilege to ensure that 
all of our employees are provided a safe working environment and 
preventions to maintain this environment at all times. Therefore, when 
an incident such as the current outbreak occurs, it is my job to ensure 
that employees receive adequate personal protective equipment, timely 
notices of exposures, and timely testing to ensure proper treatment.
    Management is required by statute and regulation to contact me 
regarding all changes in working conditions, information that needs to 
be disseminated to employees, and to request input and suggestions from 
the union. Equally important, I am the person who employees talk to 
when they have concerns, especially when they are afraid to voice those 
concerns to management on their own.
    As indicated in my timeline (Appendix A), I was not aware of any 
potential Legionella outbreak at my facility until the morning of 
November 16th, when Director Terry Wolf called the union Vice President 
Antoine Boyd. In that call, Director Wolf informed him that the water 
supply at UD was being tested for Legionella bacteria because some 
patients had reported feeling ill, similar testing would begin at Heinz 
as soon as possible, the water supply would be flushed with chlorine 
over the weekend (Nov. 17-18) and water conservation would be in effect 
for approximately two weeks until test results on the water came back.
    On November 16th at 12:36PM, management put out its first all-
employee notice at both UD and Heinz. We were informed that there would 
be no tap water for hand washing, drinking or bathing. Employees were 
instructed to use bottled water for hand washing for visibly soiled 
hands or following care of patients with Clostridium Difficile. Later 
on the 16th, UD and Heinz held town hall meetings for staff but none of 
the union officers could attend given the short notice.
    The news about water conservation did not alarm me initially. Back 
in 1994, when I started at the VA, I was advised not to drink the water 
because it had problems with Legionella, and I knew that Legionella had 
been in the pipes since at least 1981. However, over the next few 
weeks, through various emails from staff, union local officers and the 
media I began to realize that management may have learned about this 
outbreak much earlier than they represented to us. This demonstrates 
VA's failure to comply with OSHA requirements about notification and 
precautions. For example, I first assumed that flushing of the water 
system on November 13th and 14th was related to a steam line break 
earlier that month.
    Similarly, in early November (November 5th-9th), I was one of 
several employees notified of pertussis exposure. We were sent to 
Employee Health, where we were screened and given the antibiotic 
azithromycin. Later, the pertussis incident raised two red flags in my 
mind: first, if management followed OSHA rules about notice and 
screening for a pertussis outbreak, why didn't they follow these rules 
for a Legionella outbreak after receiving two confirmed cases in early 
November? Second, was it a coincidence that management provided the 
same antibiotic for pertussis exposure that would also be prescribed 
for Legionella exposure?
    Other events prior to November 16th suggested to me that 
confirmation of the outbreak occurred earlier. For example, on November 
15th, I learned through an email forwarded to AFGE Local President 
Colleen Evans at the Highland Drive (HD) facility that Executive Leader 
Mona Melham had contacted supervisors in her service line. Dr. Melham 
told the supervisors to wear masks when washing their hands and to 
drink bottled water because water had tested positive at UD for the 
same Legionella bacteria recovered 20 years ago. Dr. Melham attributed 
this recurrence to the failure of an old copper silver system that had 
been installed to eliminate the organisms, and she stated that efforts 
were underway at UD to hyperchlorinate water and conduct additional 
surveys at Heinz and HD.
    After I learned that plumbing staff was already flushing the water 
system as early as November 13th, I questioned whether employees were 
instructed to wear masks and provided with other necessary personal 
protective equipment (PPE). In my discussions with the employees 
involved with Legionella remediation, I learned that they were not 
provided with any PPEs and there were no communications from management 
regarding PPEs. I also inquired about PPEs at a January 2013 meeting 
with Director Wolf, Chief of Staff Sonel, and national AFGE leadership. 
I was disturbed when COS Sonel responded that he did not know that 
plumbing staff should be provided PPEs to flush the water systems and 
had not made any effort to determine if they were needed under OSHA 
guidelines or VA's own policy.
    Based on my growing concerns about the events unfolding around 
November 16th, I requested a meeting with management to ensure that 
employees received more accurate information. The meeting took place on 
November 20th and included union officials and executive leadership 
from the facility. During the meeting, AFGE representatives raised the 
issue of delayed notification to the union and employees as well as 
management's failure to link Legionella with employees diagnosed with 
pneumonia or exhibiting other respiratory symptoms.
    I also asked COS Sonel why management had not surveyed employees 
over recent absences and illnesses as required by OSHA. His reply was 
troubling and dismissive. He stated that employees were more likely to 
be exposed to Legionella in their own homes. Deputy Director Cord said 
that the symptoms could be related to the flu since it was flu season. 
I reminded them that many of our employees are over 50, smokers, ex-
smokers, diabetics, on corticosteroids and chemo which could place them 
at risk. At that point, management agreed to evaluate employees if they 
reported to Employee (occupational)Health. When I asked how employees 
would be treated, the response from management was if they had symptoms 
and reported to Employee Health, they would obtain a chest x-ray and if 
necessary, treated with azithromycin.
    I requested that they do an employee survey as required by OSHA and 
referred management to a sample OSHA letter on its website. COS Sonel 
replied that they could not conduct this OSHA survey because it would 
violate HIPAA (which I knew to be incorrect based on my knowledge of 
OSHA and the requirement to conduct these surveys once an outbreak 
exists).
    At the end of this meeting I was not confident that our employees 
would be screened or evaluated for this workplace exposure. Therefore, 
I utilized social media and email campaigns to inform our employees 
about symptoms related to Legionella and Pontiac Fever, including early 
flu like symptoms (slight fever, headache, aching joints/muscles, lack 
of energy, tired feeling and loss of appetite) or common pneumonia like 
symptoms (high fever, cough [dry first then phlegm producing], 
shortness of breath, chills or chest pains). If employees had any of 
these symptoms we instructed them to report to Employee Health. If the 
employees were turned away they were also told to notify the union.
    After the meeting, I learned of several instances where employees 
who went to Employee Health for screening were turned away and made to 
feel they had no right to be there. Employees were also denied urine 
antigen tests. We reported this issue to management, and I was pleased 
that it was corrected in some cases but not consistently. For example, 
some employees were still not given the urine antigen test. Others were 
treated for bronchitis with azithromycin, which can cause false 
negatives if tested for Legionella later.
    Director Wolf did send out a letter to employees (dated December 
5th) but it placed more of the burden on employees to seek screening, 
instead of complying with the OSHA requirement that management first 
screen by reviewing time of leave records for absences of three days or 
more in a six week period.
    I also learned during this process that OSHA guidance on Legionella 
requires the union to participate in inspections after an outbreak is 
confirmed, and the union should be jointly involved in potential 
abatement procedures and to participate in periodic collections of 
water samples. These requirements were never met.
    I do want to commend management for not trying to exclude AFGE from 
the process of the Root Cause Analysis when the employee requested a 
union representative be present, or from the meeting with Congressman 
Tim Murphy when he came to the VA to inquire about the Legionella 
situation. More generally, I believe Director Wolf is genuinely 
concerned about the well-being of the patients and staff, and the VA is 
currently doing everything in its means to appropriately manage 
Legionella in our water system. However, there are still serious 
concerns regarding OSHA compliance.
    Therefore, I urge that the following actions be taken in the future 
to prevent and remediate this type of outbreak, and to ensure the well-
being of patients and employees.
      More training of management and rank and file employees 
on OSHA guidelines for inspections, notifications, screenings and PPEs;
      If elevated Legionella levels are detected, start using 
bottled water and limited showers immediately and continue doing this 
as long as a risk of outbreak exists;
      Review VA's practices of using employees other than 
certified plumbers to address these water system issues. Currently, the 
Pittsburgh VA Healthcare system has only one permanent, certified 
plumber whose primary role is inspector contractor work. The hands-on 
plumbing work is performed primarily by pipefitters and steamfitters 
instead of certified plumbers who typically do this work in the private 
sector;
      Revise VA procedures for testing of Legionella in the 
pipes, including improved communication between construction teams and 
infection prevention teams. Our piping system is complex and has many 
``loops'' that require testing. Our construction is constant and 
sometimes requires shut off to water supplies. When water sits stagnant 
it can breed the Legionella colonies. We may need a stronger policy to 
demonstrate what happens when there is water interruption and to find 
ways to rid the system of the many ``dead legs'' that exist.
    Thank you again for the opportunity testify.
                              APPENDIX A:
 TIMELINE OF EVENTS SURROUNDING 2012 LEGIONELLA OUTBREAK AT PITTSBURGH 
                          VA HEALTHCARE SYSTEM
Prepared by Kathi Dahl, President, AFGE Local 2018
November 6, 2012
      AFGE received email notice about Sprinkler System 
interruption at University Drive due to a water line break.
November 14, 2012
      AFGE received email notice of Steam Outage at Heinz for 
steam line repairs. The following work was conducted: workers shut down 
the main steam service from the Boiler Plant to the hospital buildings, 
A/C shop technicians replaced 5 inch gate valve and failed gaskets on 
8x5 gate valves and then returned steam service and HVAC systems to 
full operation. Building numbers affected were 32, 49, 50, 51, 52, 53, 
54, 69, 70, and 71. This email included a utility outage contingency 
plan that indicated the steam outage would affect the entire Heinz 
campus except for the Villas. Domestic hot water was not available in 
the inpatient wings and conventional baths for patients were not 
available, patients instead used ``bath in a bag.'' There was no space 
heating available so extra blankets were provided to the patient units. 
No steam available for cooking or dishwashing for food services. Boiler 
plant and AC shop had additional staff on hand to bring the boilers and 
campus steam supply back to operating conditions as soon as possible.
November 15, 2012
      AFGE received email regarding University Drive (UD) 
Emergency Heat and Flush for November 15-16. Work was conducted in the 
following affected areas: Building 1, 3 West, 4 West, 5 West and 
Ambulatory Surgery Unit from 12am-7am on November 15-16, 2012. AFGE was 
informed FMS employees would notify the Patient Care Coordinators (PCC) 
when it was safe to use hot water once the flushing operations are 
completed.
      AFGE received email from one of our union safety stewards 
at Heinz at 2:11pm. He understood there was a problem at University 
Drive and there were several cases of bottled water that were sent to 
Oakland. He had heard Heinz would be under water shut down and 400 
cases of bottled water were ordered. He wanted to know if the union 
safety officer James Dozier or I knew anything about the water 
shutdown. I responded to him that we had received notice of the water 
outage (but no information about the Legionella.)
November 16, 2012
      I received an email from AFGE Local 2028 Executive VP 
Boyd at approximately 12:17pm telling me that VAPHS Director Terry Wolf 
called the Heinz union office because she was unable to contact me. The 
Executive VP's email indicated that the Director informed him they were 
testing UD water supply for Legionella bacteria because some patients 
were not feeling well. He was also told that they would begin flushing 
the water supply with chlorine for 24 hours starting on Saturday, 
November 17 and then flush the water supply with regular water on 
Sunday, November 18 for the whole day. He was advised by the Director 
that employees would be instructed to use hand sanitizers for hand 
washing and use bath wipes in lieu of showers for patients. The 
Director told him that the water conservation would be in effect for at 
least 2 weeks while they wait for the culture results to come back. In 
addition, she had told him that testing would begin at Heinz as soon as 
possible. She informed him of a town hall meeting this same day at 12pm 
and 4pm at the Heinz and UD facilities. One of our safety Stewards at 
UD did attend this meeting with the Logistic team on Friday.
      Email from the Director's office was sent out to all VA 
employees regarding the restricted water usage at UD and Heinz 
campuses. This email went out at 12:36pm. The employees were instructed 
that effective immediately, there would be restrictions from using tap 
water for hand washing, drinking and bathing at UD and Heinz campuses 
for all patients, employees, volunteers and visitors. They encouraged 
everyone to use hand sanitizer when possible instead of hand washing 
with soap and water. They indicated the instances to use bottled water 
for hand washing was after care for a patient with Clostridium 
Difficile and when visibly soiled. At this time the Director's office 
provided numbers for incident command center and where to request hand 
sanitizer and signage.
      There was a town hall meeting scheduled for a 12-1pm live 
meeting, but the message was not forwarded to me until 12:41pm.
      I received an email from Highland Drive (HD) AFGE Local 
3344 President Colleen Evans. She had forwarded me an email from 
Executive Leader Mona Melham dated Thursday November 15, 2012 at 
8:16pm. This email was addressed to supervisors as a high alert message 
that testing the water system at UD revealed Legionella organisms 
similar to those recovered 20 years ago. She stated it was attributed 
to the failure of the old copper-silver system installed to 
specifically eliminate the organisms. She also indicated other 
hospitals in the Pittsburgh area were dealing with similar issues; 
efforts were underway to test the Heinz and HD campuses. She informed 
them that Legionella is a micro-organism (bacteria) that can cause 
pneumonia when inhaled by immunocompromised and/or debilitated 
patients. Legionella is easily treated with ciprofloxacin, azithromycin 
or erythromycin. She instructed the supervisors to refrain from using 
water fountains and sinks until further notice and that if they had to 
wash their hands to wear a mask to prevent inhalation of aerosolized 
droplets.
      HD AFGE Local 3344 President Colleen Evans included me in 
email at 1:04pm to executive leadership. In this email she wanted to 
know why she was hearing from bargaining unit employees about the 
Legionella outbreak, hot water flushing, potential fire hazards and 
``plans'' to test water at Heinz and HD sites. She wanted to know why 
she had not received one notice from VAPHS leadership.
November 18, 2012
      I sent an email to James Rowlett (incident command) and 
Director Terry Wolf regarding employee concerns about hand hygiene and 
using the little bottles of water to do so. There was an issue where 
the employees were puncturing holes in the tops of the bottles to spray 
the water rather than pour the bottles in order to conserve water. AFGE 
recommended for future incidents that management consider using 5 
gallon water dispensers as often used by campers. Mr. Rowlett 
immediately responded and added Environmental Management Services (EMS) 
and logistics supervisors to advise them to be prepared to address this 
issue first thing Monday morning.
      I received a phone call from Marge Engwer (VA Safety 
Chief) that vendors were coming on Monday to provide hand washing 
stations.
      The Director's office sent out an email notification to 
all staff at 6:35pm that water restrictions were still in effect at 
University Drive and reminded everyone of the same information provided 
in the first Legionella notification to employees. They indicated this 
would be for approximately 2 weeks or until further notice.
November 19, 2012
      AFGE received an email from our union safety steward at 
8:26am inquiring if we had been cleared to use the water. She indicated 
that they were taking necessary precautions in regards risks related to 
use of their postage and folder machine.
      AFGE Local 3344 President Colleen Evans sent another 
email at 9:21am as a follow up to the unanswered November 16 email 
stating again that restrictions and precautions were in place for UD 
and Heinz but she had still not received notification or information at 
HD. She asked someone to tell the union office if HD had Legionella in 
the water. She wanted to know if and when the water would be tested at 
HD. The Deputy Director David Cord responded to her at 9:48am 
indicating that he had a call scheduled with her at 10am and would 
update her then.
      By end of the day when I had caught up with the emails 
and activities up to this date, I became suspicious that we had not 
been informed in a timely manner about the Legionella. At 4:20pm I 
emailed Director Terry Wolf to request a meeting between her and the 
union to discuss the facts surrounding the Legionella situation at the 
VA. At this time I informed her that an employee had approached me 
earlier that day and had been diagnosed with bacterial pneumonia. The 
employee was out for 4 weeks and this was her first day back. I 
expressed concerns to the director as to whether the Legionella was 
related to her pneumonia. I also wanted clarification for the rumors 
about whether the wrong pipes had been flushed at Heinz. Some of the 
concerns I raised were whether cold water instead of hot water was 
being flushed and whether tap water was safe to be used to serve 
coffee. The Director forwarded the email to the Deputy Director David 
Cord, Associate Director, Chief of Staff Dr.Sonel, and Infection 
Control Chief Dr. Muder. Deputy Director Cord responded at 4:52pm that 
he was acting as Director and would be able to meet the following day 
at 1pm.
November 20, 2013
      We had a meeting between the union and management about 
Legionella at 1pm. Attendees included myself, Local 3344 President 
Colleen Evans, Local 2028 Safety Officer James Dozier, Deputy Director 
David Cord, Associate Director Lovetta Ford, Dr. Sonel, and Dr. Muder.
      At this meeting, the union expressed to leadership that 
as healthcare workers we understand the risk of exposures and that 
Legionella had been in the pipes for several years so this was not a 
surprise.
      We expressed concerns that VA was conducting heat flushes 
prior to our notification and that we were not notified in a timely 
manner. VA indicated that they did not heat flush the pipes. I told 
them I had a notice that they did. They insisted they did not. Deputy 
Director Cord stated that it would put me, as the Local President, in a 
difficult position if I had that information and was not able to share 
it with the employees.
      AFGE's concerns included the construction being 
conducted, all of the ``dead legs'' within the plumbing system, and 
VA's testing protocol since Legionella existed in the pipes since 1981. 
VA advised they were routinely monitoring the pipes. The union stated 
that OSHA provides routine maintenance guidelines for flushing pipes 
with the presence of Legionella. Deputy Director Cord stated they had 
been conducting routing maintenance and monitoring the piping system. 
The union stated that Legionella must be controlled since it cannot be 
eradicated from the pipes once it is there. He indicated they were 
monitoring levels of Legionella.
      VA verbally provided the union with the plan to treat the 
situation with hyperchlorination. They stated that they had contacted 
CDC and were following their guidelines.
      We requested the plan for employee exposures to 
Legionella. They indicated that healthy employees were not at risk. I 
reminded them that many of our employees are over 50, smokers, ex-
smokers, diabetics, using corticosteroids and chemotherapy which could 
place them at risk. Leadership responded that Legionella is more likely 
to exist in our homes and is not necessarily contracted from the 
hospital. I reminded Dr. Sonel that Legionella was at the hospital and 
that if there were 2 or more diagnosed Legionella cases, OSHA 
recommends it be treated as a Legionella outbreak. I asked if they were 
going to survey employees that were out for more than 3 days to let 
them know that there was an exposure. They indicated they could not 
survey employees since it was a HIPAA violation. I responded that it 
was not a HIPAA violation and that if a Legionella outbreak occurs, 
OSHA requires that management to provide a survey letter to employees 
offering voluntary testing when an outbreak occurs. Management did not 
agree and did not commit to complete any survey.
      The union asked how we should respond to employees 
indicating they had or have pneumonia, respiratory symptoms or symptoms 
related to Pontiac Fever. Deputy Director Cord said they should go to 
their Personal Care Provider (PCP). I indicated that CA-2 forms should 
be completed for an occupational exposure. Once again they indicated 
the employees' illnesses may not necessarily be associated with 
hospital exposure to Legionella since they could be exposed at home. 
They also indicated that it was flu season and that might be the cause 
of their illness. Eventually, the VA agreed to evaluate employees if 
they reported to Employee Health. When I asked about the treatment 
plan, they said they would evaluate the employee and provide a chest X-
ray and medicate with the antibiotic azithromycin. I was not confident 
at the end of this meeting that our employees would be screened and 
evaluated for this work exposure.
      The union utilized social media and email campaigns to 
inform our employees about symptoms related to Legionella and Pontiac 
Fever, including early flu like symptoms (slight fever, headache, 
aching joints/muscles, lack of energy, tired feeling and loss of 
appetite) or common pneumonia like symptoms (high fever, cough [dry 
first then phlegm producing], shortness of breath, chills or chest 
pains) to report to Employee Health. If employees were turned away they 
were instructed to notify the union.
November 21, 2012
      I forwarded the heat and flush announcement from November 
14, 2012 to the Associate Director Lovetta Ford. She apologized and 
acknowledged the announcement; she explained that when she denied 
(during the November 20 meeting) the occurrence of pipe heating and 
flushing pipes prior to November 16, that she was referencing the 
corrective action from CDC.
      I received an email from Local 3344 President Colleen 
Evans that on November 20th, special showers were installed in 2 rooms 
on each floor of the consolidation building at UD.
      AFGE received an email from Occupational Safety 
Specialist for the VA Kevin Geeting that the deadline for submitting an 
application for the Voluntary Protection Program (an OSHA safety 
program) is approaching and he wanted continued commitment from the 2 
locals regarding participation in the VPP application.
      AFGE received an update from Deputy Director Cord that 
all the shower heads were installed and they were able to place in line 
filters in the consolidation building to create 2 shower rooms for each 
floor. Hand washing stations would be available on November 25, 2013.
November 23, 2013
      AFGE received a copy of a complaint letter from OSHA and 
VA's response to their complaint. The letter stated, ``Employees may 
potentially be exposed to a Legionella outbreak in the consolidation 
building.'' The response provided by VA Deputy Director Cord indicated 
that during routine testing, VA found some suspect samples of 
Legionella and they had contacted CDC for assistance. He also stated 
``no cases of employee exposure have been identified.''
November 25, 2013
      AFGE safety officer James Dozier states to VA safety that 
it is imperative to have hand washing stations in the Nutrition and 
Food Services at UD and Heinz campuses due to food handling. Health and 
safety issues were expressed for patients and staff.
November 26, 2012
      AFGE Local 3344 President Colleen Evans informed VA 
Safety Officer Geeting that they were withdrawing support for VPP in 
light of several safety issues that had occurred recently where VA 
failed to include or inform her local. She expressed that she no longer 
had confidence that the union would be an equal and informed partner.
      I verbally informed VA Safety Officer Geeting that Local 
2028 concurred with Local 3344's opinion and we would not be able to 
support VPP at this time.
November 30, 2012
      Water restrictions at UD were lifted but remained in 
effect for all other campuses until further notice.
      Hyperchlorination at HD was initiated due to some 
positive testing areas for Legionella. However, the treatment was moved 
to December 7-9.
      AFGE was notified that UD restrictions should remain in 
place for the ice machines. VA indicated that Facility Management 
Service would begin cleaning them over the weekend.
December 3, 2012
      AFGE Local 2028 Steward inquires about getting ``water 
buffalos'' in the villas. They did not receive hand washing stations 
for over 120 veterans and 60 employees. VA responded by sending hand 
washing stations that were no longer needed at UD.
      I informed Deputy Director Cord that I had an interview 
with the newspaper and had talked about four employees that I was aware 
of being treated for respiratory symptoms. I told him that I had 
advised the newspaper that the union is still content with the 
immediate response to the situation but would be monitoring how the 
employee exposures, if any, would be handled.
December 4, 2012
      Hand washing stations delivered to Building 69 Villas.
      AFGE began receiving inquiries from employees about an 
earlier pertussis scare which may have been due to a Legionella 
exposure. AFGE informed the Director about the employees' concerns on a 
phone call. She was very sincere and was concerned about the well-being 
of our employees and if they have any symptoms she wants them evaluated 
and treated.
December 5, 2012
      Deputy Director Cord phoned me to caution that my 
discussion with the newspaper bordered a HIPAA violation. I verbalized 
that I did not agree that my comments were violating any privacy 
issues. During this call I informed Deputy Director Cord I had been 
contacted by several news stations for on camera interviews and had 
declined, as advised by AFGE leadership. I informed him that all of my 
future communication with the media would be through AFGE leadership 
and the national Communications department.
      AFGE received information from a 5th employee that 
suggested that they may have had ``Pontiac Fever'' the week of November 
5-9 on the same week of our Pertussis scare. He had received 
azithromycin.
      Director sends out an email to all employees stating that 
the VA is working to confirm specifics about the Legionella exposure. 
VA says they are trying to determine if illness reports are pertinent 
to the outbreak and the source of infection for each reporting employee 
who sought medical care for pneumonia in recent months. She provides a 
list of symptoms related to Legionella and tells employees to report to 
their PCP or Employee Health. If they have pneumonia, they should tell 
VA as soon as possible. This letter does contain all the language 
required by the OSHA sample letter.
December 18, 2012
      AFGE was interviewed by Joint Commission Bill McCully and 
Vicki Pritchard. The Joint Commission asked the union if something 
could be done to better protect employees. The union again requested 
urine antigen tests from the VA for those employees with symptoms.
December 19, 2012
      2 plumbers came to the union office, expressing concerns 
that they may have to provide depositions. They expressed fear that 
management will try to place blame on the employees. They stated that 
they were never trained to do water treatments (Chlorination). They 
indicated that at the end of their shift on December 14 they were asked 
by their supervisor to sign a form that they were trained to do water 
treatments. They did not sign.
December 31, 2012
      AFGE received an email notice with a list of employees 
that were scheduled to meet with the Root Cause Analysis (RCA) team for 
the Legionella issue scheduled for January 3, 2013.
January 3, 2013
      RCA team conducts interview with a pipefitter and an 
infectious disease nurse.
January 9, 2013
      RCA team conducts interview with a plumber.
January 25, 2013
      AFGE received a communication from an employee voicing 
concerns about his qualifications to complete Heinz Mixing Valve 
Project as COR on this project.
January 30, 2013
      HR sends out OSHA notice to all employees of the 
employees' rights to access medical and workplace exposure records.
Executive Summary
    As President of AFGE Local 2028, I represent approximately 2,500 
non-management employees representing a wide range of positions at the 
University Drive (UD) and Heinz campuses of the Pittsburgh VA Health 
Care System. When the most recent Legionella outbreak occurred at the 
Pittsburgh VA, it was my job to ensure that employees receive adequate 
personal protective equipment, timely notices of exposures, and timely 
testing to ensure proper treatment, and to present employee concerns to 
management, especially when they were afraid of retaliation.
    I was not aware of any potential Legionella outbreak at my facility 
until Director Wolf contacted the union on November 16, 2012. However, 
I soon realized that management may have learned about this outbreak 
much earlier than the union and employees were notified and that 
preventive measures such as bottled water for patients and staff, and 
masks and other personal protective equipment for plumbing staff were 
not provided timely, in violation of OSHA requirements and VA policy. 
Management was also unwilling to comply with the OSHA requirement to 
survey employees to identify individuals may have been absent due to 
Legionella-related illness. I was also disappointed in management's 
reluctance to properly test employees for Legionella.
    Management also failed to comply with the OSHA requirement that the 
union participate in inspections after an outbreak is confirmed, be 
jointly involved in potential abatement procedures and participate in 
periodic collections of water samples.
    I recommend the following actions going forward: (1) More training 
of management and rank and file employees on OSHA guidelines for 
inspections, notifications, screenings and PPEs; (2) Start using 
bottled water and limited showers immediately and as long as a risk of 
outbreak exists; (3) Review VA's practices of using employees other 
than certified plumbers to address these water system issues; and (4) 
Revise VA procedures for testing of Legionella in the pipes, improve 
communication between construction teams and infection prevention 
teams, better understand the impact water interruption and improve ways 
of ridding the system of the many ``dead legs'' that exist.

                                 
                       Submission For The Record

    Testimony of: Edward Dudek, MPPM, Assistant Vice-President, 
Facilities, Engineering & Maintenance, UPMC Presbyterian Hospital; and 
Carlene A. Muto, MD, MS, Medical Director of Infection Prevention and 
Hospital Epidemiology, UPMC Presbyterian Hospital Center for Quality, 
Safety and Innovation

    Chairman Coffman, Ranking Member Kirkpatrick, and Members of the 
Subcommittee:

    Thank you very much for inviting the University of Pittsburgh 
Medical Center (UPMC) to testify about the important issue of 
Legionella prevention in clinical settings. We are happy to be of 
assistance in providing an understanding of the UPMC Presbyterian 
Hospital's various systems and controls employed to protect our water 
systems from contamination, specifically in this instance regarding 
legionella.
    We are Carlene A. Muto, MD, MS and Edward Dudek, both of UPMC 
Presbyterian Hospital.
    I, Carlene, am the Associate Professor of Medicine and Epidemiology 
and direct the Infection Control and Hospital Epidemiology program at 
UPMC. I am a member of the ID Epidemiology Research Unit. I received a 
Bachelor of Science Degree in medical technology from Bloomsburg 
University in Pennsylvania. After receiving a medical degree from 
Temple University School of Medicine in Philadelphia, I received 
training in infectious diseases and earned a Master of Epidemiology 
from the University of Virginia.
    I, Edward, am the Assistant Vice President of Facilities, 
Engineering and Maintenance at UPMC Presbyterian Hospital. I have been 
with the hospital in a variety of roles for the past 25 years. I have 
held my present position for approximately six years, and I have served 
as the department head for about 12 years. I hold a Bachelor's Degree 
from the University of Pittsburgh, as well as a Masters of Public 
Policy and Management Degree from the University of Pittsburgh's 
Graduate School of Public and International Affairs. Additionally, I 
hold a Class 1 Engineer's License with the National Institute for the 
Uniform Licensing of Power Engineers and a Master Plumber's License 
with Allegheny County.
    We cannot stress enough the truly collaborative approach to this 
issue. The Infection Control Department and the Facilities, Engineering 
and Maintenance Department work in tandem, with great success. Further, 
we do not want to portray ourselves as ``experts'' on Legionella or 
Legionella
    prevention. Rather, we speak from the position of department heads 
that have been fortunate enough to have kept Legionella at bay. We can 
only speak to the technology, systems and controls used to protect the 
water systems at UPMC Presbyterian Hospital.
    UPMC Presbyterian Hospital is a large academic hospital with 792 
licensed beds. This facility is the flagship UPMC hospital and is where 
major surgeries, transplants and research are conducted. The facility 
also provides general care. The oldest part of the structure dates back 
to 1938 with additional wings and additions through the mid-1990s. 
Continual internal upgrades and construction have been conducted, and 
the facility has evolved in ways that I suspect are typical of many 
older hospitals.
    We have within the facility, five separate and isolated domestic 
hot water systems; all have steam converter type water heating 
equipment with no storage tanks. Each of these individual systems has 
its own dedicated copper and silver ionization system consisting of a 
Liquitech controller and flow cell(s).
Copper and Silver Ionization System Components:
    The copper and silver ionization systems are comprised of two 
primary components. The first component is the electronic controller 
which controls the amount of copper and silver ions that are released 
into the hot water system. The second component is the copper and 
silver flow cell. Within the cell are a number of copper and silver 
bars that are immersed in the hot water system's return piping, the 
number of which is determined by the volume of water that is being 
treated.
    The controller sends an electric current at a determined amperage 
rate to the cell and directly to the immersed bars. The amperage from 
the controller to the cell regulates the rate at which the copper and 
silver bars are sacrificed, thus releasing ions into the water flow.
    The composition of the bars is typically 70 percent copper and 30 
percent silver. That composition can be changed if the operating 
characteristics of a particular system dictate that need. Typically, 
what would dictate that a change is required is a negative trend that 
is confirmed through atomic absorption testing of the hot water system. 
There are optional control devices that can be used, such as flow 
meters and continuous copper analyzers that can automatically adjust 
the output set point of the controller. However, the operating 
characteristics, the size, and the consistent flow rates of our systems 
provide a situation where a manual constant set point provides the most 
reliable operation that is confirmed through atomic absorption testing.
    These are the components of a copper and silver ionization system, 
but proper operation can only be achieved in a properly-designed and 
fully-operational hot water system with a strong and consistent return 
loop. Inadequate flow, undersized pumps, or long lengths of pipes 
connecting the distil sites to the return loop will decrease the 
ability to properly sanitize the hot water systems. These issues with 
the return system can be an issue in older buildings or larger systems, 
but we address any such deficiencies through ongoing construction 
projects and through routine operation repairs. In extreme cases, the 
hot water systems may actually be split into a number of smaller 
systems.
Operation:
    The systems operate by electrically sacrificing the copper and 
silver bars and introducing those minerals into the hot water system. 
The minerals are continuously circulated throughout the system, 
sanitizing all surfaces they come into contact with. A considerable 
amount of minerals are also captured within the bio-film on the 
interior pipe surfaces, providing residual sanitization if the system 
would be out of service for brief periods of time.
    Any interruption of this type in excess of 24 hours would initiate 
discussion with the Infection Control Department to determine if 
additional steps are necessary. Over the past operations, we have never 
had an interruption in the system service of this type and duration.
    The rate of sacrifice of the bars is controlled by the electronic 
controller through the output amperage setting. The amperage set point 
is controlled by one of three methods:

    1. Constant Set Point - the amperage is set and remains at that 
level until it is manually changed.

    2. Flow Rate - the amperage is raised or lowered in conjunction 
with the make-up flow rate of the cold water into the system. The set 
point is lowered at low usage times and raised as the water usage 
increases.

    3. Constant Copper Analysis - there is an analyzer that constantly 
monitors the copper levels in the return loop of the hot water system. 
If the copper level drops below a predetermined set point, the amperage 
level automatically increases.

    Again, due to the volume of water that our facilities use and after 
a decade of experience, we have found the Constant Set Point method to 
be the most effective in treating our system.
    The set point is determined by the levels of copper and silver in 
the systems compared to the predetermined levels required by our 
Infection Control Department and the recommendations by the
    Allegheny County Health Department. The copper and silver levels 
required are .2-.8 ppm and .02-.08 ppm, respectively.
Testing and adjusting:
    The copper levels are tested two times per week using a hand-held 
device. During this testing, the copper levels are recorded as well as 
the amperage set point, the voltage reading, the hot water supply 
temperature, and the hot water return temperature. No system 
adjustments are made from these copper results.
    The voltage reading is of particular importance during this 
inspection. If the voltage has increased significantly, it typically is 
an indication that the bars may be deteriorated to a level that affects 
their ability to sacrifice or are dirty. Either of these situations can 
affect the operation. If this situation exists, we change out the flow 
cell and/or clean the cell and sacrificial bars and verify that the 
system is operating appropriately.
    Monthly, the Facilities, Engineering and Maintenance Department 
collects water samples from numerous areas throughout the building and 
from each individual hot water system loop. The copper and silver 
levels in these water samples are tested monthly through an outside 
laboratory using atomic absorption. All system adjustments are made 
based on the independent atomic absorption lab test results. The atomic 
absorption results are then sent to the Facilities, Engineering and 
Maintenance Department and Infection Control Department for review. If 
the levels are outside of the required parameters, there is a 
discussion between the two departments and the proper course of action 
is determined by the Infection Control Department.
Maintenance:
    In addition to the cell in service on each system, there is a spare 
cell always on site. The cells in service are checked bi-weekly for 
operation and are cleaned as required. Cleaning is performed with a 
lime-removing chemical and a wire brush. During the bi-weekly 
maintenance, the cells are pulled from the system and cleaned or 
replaced. If the bars are sacrificed beyond approximately ='' diameter, 
that cell is pulled and replaced with the spare, and the depleted cell 
is sent out to our local supplier to be rebuilt, replacing the 
sacrificial copper/silver bars.
Exception-Based Thermal Eradication:
    If ion levels and test results are outside of set points, a 
collaborative discussion between the Facilities, Engineering and 
Maintenance Department and the Infection Control Department takes place 
to determine if the system(s) may be vulnerable to contamination. If it 
is determined that the system may be vulnerable to contamination, we 
perform a thermal eradication of the entire system. This is initiated 
and managed by the Facilities, Engineering and Maintenance Department 
and the Infection Control
    Department in collaboration with Nursing, Clinical Operations and 
our Environmental Health and Safety Department.
    This process provides a level of protection from contamination for 
a period, as the Facilities, Engineering and Maintenance Department 
addresses and investigates the cause for our readings straying from set 
point and system operations are restored.
    In summary, Mr. Chairman, while copper-silver ionization is one of 
the most effective and cost-effective methods available, the success of 
any disinfection modality is dependent not only on the equipment, but 
also on the overall hot water system management, the consistency of 
Legionella surveillance, water monitoring, duration of the disinfection 
measure and cooperation among the Infection Control personnel, 
Engineering Staff and Administration.
    Thank you, Mr. Chairman and committee members, for the opportunity 
to provide this testimony to you. We stand ready to answer any 
questions you might have.

                                 
                        Question For The Record

    Letter From: Hon. Michael H. Michaud, Ranking Minority Member, Full 
Committee, To: Hon: Eric K. Shinseki, Secretary, Department of Veterans 
Affairs

    March 5, 2013

    The Honorable Eric K. Shinseki
    Secretary
    U.S. Department of Veterans Affairs
    810 Vermont Avenue, NW
    Washington, DC 20420

    Dear Mr. Secretary:

    In reference to our Full Committee hearing entitled, ``Analyzing 
VA's Actions to Prevent Legionnaire's Disease in Pittsburgh'' that took 
place on February 5, 2013, I would appreciate it if you could answer 
the enclosed hearing questions by the close of business on April 15, 
2013.
    In preparing your answers to those questions, please provide your 
answers consecutively and single-spaced and include the full text of 
the question you are addressing in a bold font. To facilitate the 
printing of the hearing record, please e-mail your responses in Word 
format, to Carol Murray at [email protected] by the close of 
business on April 15, 2013. If you have any questions please contact 
her at 202-225-9756.

    Sincerely,

    MICHAEL H. MICHAUD
    Ranking Member

    CW:cm

                                 


    Questions From: Hon. Michael H. Michaud, Ranking Minority Member, 
Full Committee, and Hon. Ann Kirkpatrick, Ranking Minority Member, 
Subcommittee on Oversight and Investigations To: Department of Veterans 
Affairs
Questions Submitted by Ranking Member Kirkpatrick
    1. Please provide the Committee with a detailed timeline regarding 
when VA Pittsburgh Health Care personnel realized that they had a 
possible problem with controlling Legionella growth? What actions were 
taken, by whom, and were these actions appropriate?

    2. What role does the National Infection Control Office have in 
educating, training, or oversight of the VA's national Legionella 
Prevention Program? Does VA plan to strengthen the role of this office 
in order to better coordinate responses to other Legionella outbreaks 
if they occur?

    3. One of the recommendations of the CDC investigation was to 
improve communication between the laboratory or the infection 
prevention team and health care providers when a positive result is 
found. How does VA ensure that communication lines stay open and that 
everyone is trained on the proper procedures to follow?

    4. One of the recommendations of the CDC report was to have persons 
responsible for carrying out the hospital's Legionellosis prevention 
plan, including infection prevention, facilities management, building 
engineering, and the Legionella laboratory, meet regularly in-person as 
a team to facilitate communication.

    a. Has the VA implemented, or planned to implement, this 
recommendation?

    b. What are the roles and functions of the Infection Control 
Committee at the facility level?

    c. By what process or mechanism does facility Infection Control 
Committees have with VA Central Office?

    5. One of the findings of the CDC points to VA's reliance upon an 
action threshold (30 percent of distal sites positive) to prompt 
remediation that may not be adequate since CDC found cases occurred 
when sampling indicated that less than 30 percent of sites were 
colonized.

    a. Would you agree that this finding indicates that VA may need new 
standards for remediation?

    b. Does VA have a plan to reevaluate some of the other existing 
policies and guidelines that may not be adequate when it come to 
preventing Legionella?

    6. Since this outbreak, has VA done any nationwide polling of other 
VA facilities as to testing, surveillance and general compliance with 
existing policy?

    a. Have you become aware of any other facilities that have had 
problems controlling Legionella?

    b. Are best practices shared throughout the system and if so, how 
are they shared?

    7. When were the employees notified of a possible risk for exposure 
to Legionella and what precautions were taken?

                                 


    Responses From: Department of Veterans Affairs, To: Hon. Michael H. 
Michaud, Ranking Minority Member, Full Committee, and Hon. Ann 
Kirkpatrick, Ranking Minority Member, Subcommittee on Oversight and 
Investigations

    1. Please provide the Committee with a detailed timeline regarding 
when VA Pittsburgh Health Care personnel realized that they had a 
possible problem with controlling Legionella growth? What actions were 
taken, by whom, and were these actions appropriate?
    Response: Yes, the actions taken were appropriate given the 
information that was available at the time of the occurrence. VA 
Pittsburgh Healthcare System (VAPHS) has a history of performing 
routine environmental testing of its potable water system as well as an 
active infectious disease surveillance program. Three cases of 
Legionella pneumonia were diagnosed during the summer and late fall of 
2012. Environmental testing had not demonstrated positive findings in 
areas the patients had occupied, yet it seemed feasible that the 
infections were hospital acquired given the incubation period of the 
disease. In October, 2012, VAPHS sent to the Centers for Disease 
Control and Prevention (CDC) three samples for testing (one 
environmental and two clinical). Also, late that month, CDC linked the 
two patient cases of Legionella pneumonia at VAPHS's University Drive 
campus and the environmental water sample within the facility. In early 
November 2012, VAPHS consulted with CDC and the Allegheny County Health 
Department (ACHD) to conduct a collaborative review of the Legionella 
observations. Below is the timeline of activities that progressed from 
the confirmation that there was a Legionella issue to present. It 
should be noted that there have been no new cases of hospital-
associated Legionella since these measures were implemented.

      Beginning November 7, 2012, the CDC/ACHD team conducted a 
review of patient records and collected environmental samples for 
testing.
      On November 9, 2012, VAPHS cultured 44 water samples; 
slightly more than one-half of those samples tested positive for 
Legionella. The VAPHS promptly implemented an aggressive, multiphase 
water remediation effort per CDC recommendation. Phase one of this 
effort involved superheating the potable water system to 160 to 170 
degrees Fahrenheit and then flushing this system with a goal of 
eliminating any existing Legionella bacteria. On November 14, 2012, 
VAPHS performed water system super-heating. As an added measure, VAPHS 
then hyper-chlorinated its water system and instituted water-use 
restrictions. Hyper-chlorination of the water supply began on November 
16, 2012. VAPHS provided an alternate water supply in the interim.
      Water restrictions at the University Drive and HJ Heinz 
campuses were initiated on November 16, 2012. Restrictions were lifted 
on November 30 at the University Drive campus and December 7 at the HJ 
Heinz campus, when environmental cultures indicated successful 
remediation.
      On November 16, 2012, VAPHS leadership activated an 
incident command center, and tasked this center with clarifying facts 
and communicating news and updates to VAPHS Veterans and employees. The 
command center established a call center to answer questions from 
Veterans, staff, and family members. The command center also notified 
stakeholders of town hall meetings held by the VAPHS Director at all 
VAPHS campuses.
      Additionally, VAPHS notified providers to increase 
testing of both urine and sputum for evidence of Legionella infection, 
enhanced its mechanisms for reporting cases of Legionnaires' disease 
within VAPHS and to the Pennsylvania version of the National Electronic 
Disease Surveillance System (PA-NEDSS), and limited Veterans' 
environmental exposure to water while in the hospital.
      On December 6, 2012, environmental cultures for 
Legionella at the HJ Heinz campus were confirmed to be negative. VAPHS 
continues to conduct water testing in remediated areas every 2 weeks. 
Any areas that test positive are remediated again.
      The Veterans Health Administration (VHA) Central Office 
sent a team of clinical and environmental subject matter experts to 
review the events and issues surrounding the Legionella pneumonia cases 
and to review practices and protocols related to Legionella prevention 
and control. The team was at the facility from December 17, 2012 to 
December 18, 2012. They also focused on identifying lessons learned and 
understanding possible additional future prevention measures.
      On December 18, 2012, two surveyors from The Joint 
Commission (infection prevention and life safety) arrived at VAPHS to 
conduct an unannounced, for-cause survey. The Joint Commission may 
conduct a for-cause survey if the occurrence of an event creates either 
of the following situations: concern that a continuing threat to 
patients may exist; or, indication that the hospital is not or has not 
been in compliance with The Joint Commission policy. The focus of this 
visit was to evaluate the detection and remediation of Legionella. 
Interviews were conducted with senior leadership, engineering, 
infection prevention and control, and the union president. Tracers were 
completed through chart reviews of Legionella, transplant, and 
pneumonia cases. VAPHS has received The Joint Commission results. There 
were two findings. First, the surveyors observed that the hospital had 
not yet completed a mapping and inventory of the entire water piping 
system and indicated that this must be accomplished to identify areas 
of stagnation and ``dead heading.'' Second, the surveyors observed that 
the infection prevention and control plan should be studied in an 
effort to reduce the number of entry points, and hence the potential 
for error. VAPHS received notification on March 1, 2013, from The Joint 
Commission, that the evidence of standard compliance has been accepted 
and no further response is required.
      The Office of Inspector General (OIG) agreed to examine 
this issue and VAPHS welcomed their review, which began on January 14, 
2013. Findings from the OIG healthcare inspection were released on 
April 23, 2013.
      VAPHS has implemented several new approaches to 
maintaining open and clear communication between laboratory personnel, 
infection prevention and control practitioners, facilities management, 
and VAPHS leadership. These processes will ensure that all testing and 
remediation of distal water sites is clearly documented and that 
patient communication, in cases of possible Legionella exposure, can be 
quickly implemented along with appropriate intervention.
      VAPHS chartered a water safety committee with 
representation from facilities management, infection prevention and 
control, laboratory, the safety office, executive leadership, the 
research department, and local union officials. All aspects of 
Legionella control including water testing, water remediation, 
construction projects, and issues with water quality from the local 
water authority are discussed and interventions implemented where 
appropriate.
      VAPHS implemented a database project which required that 
every distal water outlet in the facility be uniquely identified with a 
number and barcode. As water samples are taken, the individual sink or 
shower is identified and linked to the specific sample. In the event 
that a sample result is positive for Legionella, an electronic work 
order would be placed and the individual number of that work order 
would be linked to the distal site and sample so that the remediation 
may be specifically identified and described. This system will 
facilitate the tracking and randomization of sampling sites as well as 
queries into areas where remediation has taken place so that trends may 
be identified. The database will also create a documentation trail 
which is searchable and easily monitored and audited. The capability 
exists to add events such as construction activities and newly 
installed distal water outlets.
      Institutional disclosures are scheduled through the 
middle of May 2013, to those identified as having a hospital-associated 
or probable hospital-associated case of Legionella. Over half the 
disclosures are complete.
      In accordance with current practice, Veterans who 
contract Legionella are told whether their infection was a result of 
exposure within the facility or from elsewhere in the community. In 
cases where Legionella is community-associated, testing of their home 
water system will be offered.
      A comprehensive water chlorination system will be 
installed for the treatment of all water entering all patient care 
campuses. This system will replace the chlorine drip system currently 
in place and will serve as a secondary Legionella mitigation control 
system. VAPHS is still considering options for chlorination systems due 
to the relative advantages and disadvantages of chlorine delivery 
methods. On February 19, 2013, a third party consultant arrived to 
assess the VAPHS water systems and provide recommendations for 
effective chlorination system options.
      VAPHS developed a scope of work to map the entire 
plumbing system, update diagrams, and identify unused plumbing sections 
(dead legs) in the system. The contract is on schedule to be awarded in 
May 2013. The goal is to eliminate areas of water stagnation that could 
lead to Legionella amplification. This was a recommendation of The 
Joint Commission and of the CDC.
      Decorative fountains and water features were drained and 
taken out of service since they were also identified as a potential 
source of infection. This was a specific recommendation of the CDC.
      Long-term Legionella mitigation plans include the 
installation of mixing valves on every point of use showerhead and 
faucet to allow circulating water temperatures to be increased to over 
130 degrees Fahrenheit. The contract for this project was awarded on 
February 8, 2013, and work is expected to start in April 2013. The goal 
for project completion is August 2013. Increasing the temperature of 
circulating hot water was a recommendation of the panel of subject 
matter experts sent from VHA Central Office.
      VAPHS is following the water sampling protocol discussed 
and recommended by the CDC. VAPHS conducts sixty random samples across 
its three facilities every two weeks. Each sample is one liter in 
volume which is in accordance with the CDC recommendations. The CDC has 
recommended that bi-weekly sampling continue until good long-term 
control of Legionella can be demonstrated. The determination as to when 
good long-term control has been achieved will be made in close 
consultation with the CDC and any change in the sampling plan will be 
carefully documented and monitored but will remain well within the 
requirements set forth by VHA Directive.
      Any distal water outlets that show a result positive for 
Legionella will be re-tested after remediation until samples 
demonstrate that there is no further Legionella growth at that water 
outlet. All distal water outlets have been individually identified at 
all VAPHS campuses and water samples are tracked to the exact distal 
outlet.
      Any sites that test positive for Legionella will be 
remediated using the electronic work order process which will permit 
all sites, their sampling history, and remediation history, to be 
stored in a single database for accountability, monitoring, and process 
auditing.
      VAPHS continues to test any Veteran presenting with 
symptoms of pneumonia for Legionella infection with both urinary 
antigen and sputum tests.
      A small subgroup of the water safety committee has been 
tasked to study variables such as heat, pH, dissolved solids, and other 
organic matter that may impact the concentration of chlorine present in 
various sections of the plumbing system. The subgroup consists of VAPHS 
researchers with expertise in epidemiology and healthcare database 
design as well as the facilities manager, and representatives of 
facility leadership. A consultant specializing in the evaluation of 
plumbing systems utilizing chlorine-based Legionella prevention will 
also be included. The purpose of this subgroup effort will be to assess 
what relationships exist between chlorination levels in various 
plumbing segments and other variables present in the water such as 
temperature, pH, dissolved solids, and other organic matter. The 
findings will be informative for VAPHS policy and may lead to knowledge 
that can be informative for other healthcare facilities.
      The Allegheny County Health Department (ACHD) has 
recognized that Legionella exposure and infection is a matter of public 
health concern and requires a regional response that addresses 
mitigation strategies from a standpoint of public policy. To that end, 
ACHD has proposed a task force which would seek input from community 
and healthcare stakeholders in order to inform public policy regarding 
optimal strategies to mitigate Legionella risk on a regional level. 
VAPHS has expressed a strong level of interest in participating in the 
effort and a task force charter is pending.

    2. What role does the National Infection Control Office have in 
educating, training, or oversight of the VA's national Legionella 
Prevention Program? Does VA plan to strengthen the role of this office 
in order to better coordinate responses to other Legionella outbreaks 
if they occur?

    Response:

      The National Infectious Diseases Service (formerly known 
as the Infectious Diseases Program Office) had a primary role in 
developing Veterans Health Administration (VHA) directive Legionella 
prevention policies, along with other stakeholders such as engineering, 
public health and laboratory. The Infectious Diseases Program Office, 
Healthcare Engineering, and Pathology and Laboratory Medicine Service 
are listed in these policies as the national contacts for facilities 
that have questions about Legionella disease and prevention or request 
consultation on their policies or activities.
      When VHA Directive 2008-010 (Prevention of Legionella 
Disease) was published in 2008, the National Infectious Diseases 
Service had a primary role of communicating the new policy to 
facilities and numerous outreach modalities were used at the time. For 
example:

    I   The Directive was e-mailed to the VHA Publications distribution 
group - the routine mechanism for distribution of new policies.
    I   The Directive was e-mailed to key groups such as Infection 
Prevention and Control professionals across the country.
    I   National phone calls with different stakeholders [e.g. Network 
leadership, facility leadership, facility Infection Prevention and 
Control professionals, and facility laboratory professionals] were held 
to provide education on the Directive's components.
    I   In 2011, the National Infectious Diseases Service developed an 
educational information sheet for all facilities to reinforce and 
clarify components of the Directive.

      In recent months, the National Infectious Diseases 
Service has collaborated with VHA Office of Operations and Management 
program offices to reach out to facilities in numerous ways to again 
reinforce implementation of Legionella prevention policies. For 
example:

    I   An Information Letter was published and distributed in January 
2013 to emphasize the components of VHA's Legionella policies.
    I   National phone calls have been held with various stakeholders, 
which have included Network Directors, and Engineering, Safety and 
Health Managers.
    I   A memorandum was distributed by VHA's Office of Operations and 
Management reinforcing the need for facilities to follow VA's written 
Legionella policies.
    I   An updated Information Letter was published and distributed in 
May 2013 to emphasize the components of VHA's Legionella policies.

      VHA has worked to strengthen and enhance its Issue Brief 
reporting system - a system in which facilities report issues to their 
Network Office, which then can forward the issue to VHA Central Office 
and the appropriate subject matter experts/offices are informed and/or 
consulted.
      Legionella prevention is a multifaceted issue that 
involves numerous stakeholders - for example, infection prevention and 
control, engineering, operations, laboratory, and others - and these 
entities came together when the Directive policy was developed 6 years 
ago. Concerted efforts have also been made in recent months to improve 
routine communication between the National Infectious Diseases Service 
with other Central Office entities, such as Operations and Engineering, 
for the exact purpose of coordinating communications with facilities. 
Examples of this communication include:

    I   Regular contact between Operations leadership and the National 
Infectious Diseases Services has been strengthened.
    I   VHA National Infectious Diseases Service, the Office of Public 
Health, and Office of Operations and Management collaborated on an 
educational Information Letter on Legionella prevention.
    I   National Infectious Diseases Service and Engineering jointly 
interface with facilities that request assistance regarding Legionella 
prevention.

    3. One of the recommendations of the CDC investigation was to 
improve communication between the laboratory or the infection 
prevention team and health care providers when a positive result is 
found. How does VA ensure that communication lines stay open and that 
everyone is trained on the proper procedures to follow?
      
    Response: VAPHS chartered a water safety committee with 
representation from facilities management, infection prevention and 
control, laboratory, the safety office, executive leadership, the 
research department, and local union officials. All aspects of 
Legionella control including water testing, water remediation, 
construction projects, and issues with water quality from the local 
water authority are discussed and interventions implemented where 
appropriate. This allows for rapid and thorough communication between 
the laboratory or infection prevention team and health care providers 
in the event of a positive result. In addition, identified training 
needs are reviewed and addressed through the use of competency 
validation with remedial education where indicated.
    VAPHS implemented a database project which required that every 
distal water outlet in the facility be uniquely identified with a 
number and barcode. As water samples are taken, the individual sink or 
shower is identified and linked to the specific sample. In the event 
that a sample result is positive for Legionella, an electronic work 
order would be placed and the individual number of that work order 
would be linked to the distal site and sample so that the remediation 
may be specifically identified and described. This system will 
facilitate tracking and randomization of sampling sites as well as 
queries into areas where remediation has taken place so that trends may 
be identified. The database will also create a documentation trail 
which is searchable and easily monitored and audited. The capability 
exists to add events such as construction activities and newly 
installed distal water outlets.

    4. One of the recommendations of the CDC report was to have persons 
responsible for carrying out the hospital's Legionellosis prevention 
plan, including prevention, facilities management, building 
engineering, and the Legionella laboratory, meet regularly in-person as 
a team to facilitate communication.

    a. Has the VA implemented, or planned to implement, this 
recommendation?

      Response: Yes. VAPHS chartered a water safety committee 
with representation from facilities management, infection control, 
laboratory, the safety office, executive leadership, the research 
department, and local union officials. All aspects of Legionella 
control including water testing, water remediation, construction 
projects, and issues with water quality from the local water authority 
are discussed and interventions implemented where appropriate.

    b. What are the roles and functions of the Infection Control 
Committee at the facility level?

    Response: The committee reports to the executive leadership through 
the executive leadership board. The committee serves as a forum that 
brings key stakeholders and clinical service leaders together to 
establish an organization-wide, evidence-based infection prevention and 
control program that identifies risks for healthcare-associated 
infection (HAI) and responds by reducing risks that may lead to the 
transmission and acquisition of HAI among patients, staff, volunteers, 
and visitors. The committee focuses on minimizing the risks for HAI 
through collaboration with other services in the medical center.

    c. By what process or mechanism does facility Infection Control 
Committees have with VA Central Office?

    Response: Infection control committees operate at the local 
facility level for local infection prevention and control decisions. 
Any identified issues or concerns raised to facility leadership can be 
forwarded to VHA Central Office using the Issue Brief reporting system 
- a system where facilities report issues to their Network Office, 
which then can forward the issue to VHA Central Office where the 
appropriate subject matter experts/offices are informed and/or 
consulted. In addition, local facility leaders can reach out directly 
to VHA services and program offices, such as the National Infectious 
Diseases Service, for consultative assistance and/or advice.

    5. One of the findings of the CDC points to VA's reliance upon an 
action threshold (30 percent of distal sites positive) to prompt 
remediation that may not be adequate since CDC found cases occurred 
when sampling indicated that less than 30 percent of sites were 
colonized.

    a. Would you agree that this finding indicates that VA may need new 
standards for remediation?

    Response: A Work Group that consists of VA subject matter experts 
(e.g. engineering, infectious diseases, infection prevention and 
control, public health, occupational safety and health, laboratory, 
construction and facilities management) is actively meeting to review 
and revise existing VA Legionella prevention policies, including a 
review of remediation guidance. Numerous information resources are 
being used by the Work Group such as published scientific articles, CDC 
recommendations, information from professional groups [e.g. the 
American Society of Heating, Refrigerating and Air Conditioning 
Engineers (ASHRAE)], and recent lessons learned.

    b.Does VA have a plan to reevaluate some of the other existing 
policies and guidelines that may not be adequate when it come (sic) to 
preventing Legionella?

    Response: Yes. The Work Group outlined in part (a) of this question 
is reviewing all aspects of current VA Legionella prevention policies. 
Numerous information resources are being used by the Work Group such as 
published scientific articles, CDC recommendations, information from 
professional groups [e.g. the American Society of Heating, 
Refrigerating and Air Conditioning Engineers (ASHRAE)], and recent 
lessons learned.

    6. Since this outbreak, has VA done any nationwide polling of other 
VA facilities as to testing, surveillance and general compliance with 
existing policy?

    a. Have you become aware of any other facilities that have had 
problems with controlling Legionella?

    Response: VA is not aware of any Legionnaires' disease outbreaks 
currently in other VHA facilities. VA Central Office is continuing to 
reach out to and assist any facilities regarding routine environmental 
controls to prevent Legionella.

    b. Are best practices shared throughout the system and if so, how 
are they shared?

    Response: Yes. VHA has a number of mechanisms to share best 
practices throughout the health care system. Formal and public 
mechanisms include the routine updating of directive policies, and the 
publication of information letters. Other mechanisms include national 
teleconferences, educational conferences, and webinar series to provide 
information to specific groups in the VHA health care system.

    7. When were the employees notified of a possible risk for exposure 
to Legionella and what precautions were taken?

    Response: Water restrictions at University Drive and HJ Heinz 
campuses were initiated on November 16, 2012, and were lifted on 
November 30, 2012, at the University Drive campus and December 7, 2012, 
at the H J Heinz campus, when environmental cultures indicated 
successful remediation. On November 16, 2012, leadership activated an 
incident command center, and tasked this center with clarifying facts 
and communicating news and updates to VAPHS Veterans and employees to 
include: the establishment of a call center to answer questions from 
Veterans, staff, and family members and notifications of town hall 
meetings held by the VAPHS Director at all VAPHS campuses. An employee 
fact sheet was made available and additional information as well as 
questions and answers were posted on the facility's internet and 
intranet websites. Employees with concerns about their health status or 
risk of exposure were encouraged to contact the infection control and 
prevention program office or to report to employee health for 
evaluation.

                                 


    Letter From: Hon. Michael H. Michaud, Ranking Minority Member, Full 
Committee, To: Dr. Lauri Hicks, D.O., Medical Epidemiologist, Division 
of Bacterial Diseases,Centers for Disease Control and Prevention, U.S. 
Department of Health and Human Services

    June 19, 2013

    Dr. Lauri Hicks, D.O.
    Medical Epidemiologist
    Division of Bacterial Diseases,
    Centers for Disease Control and Prevention
    U.S. Department of Health and Human Services

    Dear Dr. Hicks:

    Thank you for appearing before the Committee on Veterans' Affairs 
on February 5, 2013, to testify at the hearing entitled ``Analyzing 
VA's Actions to Prevent Legionnaire's Disease in Pittsburgh''. I 
appreciate the time and effort you gave as a witness before the Full 
Committee.
    Following the hearing, the Committee wrote to you on March 5, 2013, 
requesting additional information. We have yet to receive your 
response. I have taken the liberty in attaching the letter and 
questions for the record. It would be greatly appreciated if you would 
respond to the attachment as soon as possible so we can finalize this 
particular hearing.
    Committee practice permits the hearing record to remain open to 
permit Members to submit additional questions to the witnesses. 
Attached are additional questions directed to you.
    In preparing your answers to these questions, please provide your 
answers consecutively and single-spaced and include the full text of 
the question you are addressing in bold font. To facilitate the 
printing of the hearing record, please e-mail your responses in Word 
format, to Carol Murray at [email protected] by the close of 
business on July 31, 2013. If you have any questions please contact her 
at 202-225-9756.

    Sincerely,

    MICHAEL H. MICHAUD
    Ranking Member

    CW:cm

                                 


    Questions From: Hon. Michael H. Michaud, Ranking Minority Member, 
Full Committee, To: Centers for Disease Control and Prevention, U.S. 
Department of Health and Human Services

    1. It seems that there is not a huge amount of consensus as to the 
best way to keep Legionella under control, what system to use, how 
often to test, how vigilant should a program be etc.

    a. Could you please give us a quick synopsis of the CDC guidelines 
and how you work with other organizations to help guide them through 
the Legionella prevention programs?

    b. What are the CDC reporting requirements in the case of an 
outbreak?

    2. According to the CDC legionellosis is on the rise. The United 
States has seen an increase of 217 percent between 2000-2009.

    a. What help do you need from us to formulate more of a national or 
federal program with a goal of coming to a better consensus on handling 
Legionella?

    b. Do you think more focused research is needed?

    c. What would a program like that look like?

                                 


    Response From: Centers for Disease Control and Prevention, U.S. 
Department of Health and Human Services, To: Hon. Michael H. Michaud, 
Ranking Minority Member, Full Committee

    1. It seems that there is not a huge consensus as to how to keep 
Legionella under control, what system to use, how often to test, how 
vigilant a program should be etc.

    a. Could you please give a quick synopsis of the CDC guidelines and 
how you work with other organizations to guide them through the CDC 
Legionella prevention programs?

    CDC published Guidelines for Preventing Health-Care-Associated 
Pneumonia, 2003 (Recommendations of CDC and the Healthcare Infection 
Control Practices Advisory Committee) in 2004.1 These guidelines are 
intended for use by public health authorities and other persons 
involved in preventing healthcare-associated infections. The guidelines 
provide information regarding how Legionnaires' disease cases should be 
identified, how to respond to cases that are healthcare-associated, and 
recommendations for remediation of water systems. CDC staff are liaison 
members to The American Society for Heating Refrigerating and Air 
Conditioning Engineers (ASHRAE) committees that publish Standards and 
Guidelines that focus on the environmental control of Legionella. 
ASHRAE Standard 12-2000, Minimizing the Risk of Legionellosis 
Associated with Building Water Systems, is used by facility managers, 
engineers, and public health authorities to address Legionella in the 
environment. Currently under public review, ASHRAE Standard 188, 
Prevention of Legionellosis Associated with Building Water Systems, 
when approved and published, will complement the ASHRAE Guideline. CDC 
subject matter experts worked with ASHRAE to develop the Standard, 
which provides a framework for preventing Legionella colonization of 
water systems. This ASHRAE Standard is the first document of this kind 
in the United States to focus on primary prevention.
    CDC provides assistance, at the request of state and local health 
authorities, to identify the source for legionellosis outbreaks, 
conduct environmental and epidemiologic investigations, and provide 
recommendations to prevent ongoing disease. While CDC makes 
recommendations for short term remediation, CDC does not provide 
recommendations for long-term remediation, as there is no ``one size 
fits all approach to Legionella control''. Well-designed studies that 
address long-term remediation and prevention of Legionella colonization 
in water systems are needed.

    b. What are the CDC reporting requirements in the case of an 
outbreak?

    Legionellosis is a nationally notifiable disease. However, each 
state health department has the jurisdiction to establish the reporting 
requirements. Most states require that legionellosis cases be reported 
to the state department of health, and, in turn, the state department 
of health reports cases to CDC. As part of the reporting process, the 
state or local health department is asked to determine whether the case 
is associated with an outbreak. This determination is at the discretion 
of the reporter and is submitted at the time the case is reported. It 
is common for cases to be initially reported as sporadic and then later 
be identified as part of an outbreak after additional cases are 
reported. We recommend that all state health departments report 
outbreaks directly to CDC's Legionella program as soon as they are 
recognized, but it is at the discretion of the state public health 
authorities to determine the urgency of the situation and decide 
whether CDC's assistance is needed. CDC also has a surveillance system 
called The National Outbreak Reporting System (NORS), which is a web-
based platform designed to support reporting to CDC by local, state, 
and territorial health departments in the United States of all 
waterborne disease outbreaks. States are required to report 
legionellosis outbreaks through this mechanism as well, but they are 
typically reported after the investigation is completed.

    2. According to CDC, legionellosis is on the rise. The United 
States has seen an increase of 217 percent between 2000-2009.

    a. What help do you need from us to formulate more of a national or 
federal program with a goal of coming to a better consensus on handling 
Legionella?

    Based on current resource levels, CDC's priority is to respond to 
and stop disease outbreaks. CDC currently has a team of two 
epidemiologists and three laboratorians who work on Legionella 
routinely with others playing supporting roles and providing capacity 
for surge response. The team receives over 200 consultations and 
conducts an average of five field investigations each year. Much of 
what is known about Legionnaires' disease has been learned through 
outbreak investigations, but most, approximately 90 percent, of 
Legionnaires' disease cases are acquired in the community, and most 
cases are not associated with outbreaks. However, Legionella is one of 
the most common causes of waterborne disease outbreaks and is the most 
common cause of outbreaks associated with drinking water systems.

    b. Do you think more focused research is needed?

    There are gaps in knowledge related to Legionella and Legionnaires' 
disease. Research is needed to better understand both the human and 
environmental factors that are contributing to the increase in reported 
cases, as well as the major sources of infection in the community. 
Research is also needed to improve diagnostic testing and identify best 
practices for disease prevention and control. Development and 
evaluation of newer technologies to diagnose cases, particularly 
molecular testing and urine tests, could enhance disease detection. 
Studies should assess different strategies to prevent disease and 
outbreaks. Approaches to prevent Legionella growth in the environment 
need to be evaluated and to recognize and detect outbreak-causing 
strains. Well-designed studies that evaluate the different strategies 
and disinfection approaches to stop Legionella growth in the 
environment once it is detected are also needed.

    c. What would a program like that look like?

    This effort would include:

    1. National, State, and local epidemiologic and laboratory capacity 
to detect, report, and investigate legionellosis cases, along with 
expanded engineering and environmental health expertise in the 
Legionella program;

    2. Improved communication and education among healthcare providers 
and infection preventionists to improve testing practices and detection 
of legionellosis cases;

    3. Partnerships with researchers in academia, healthcare, and 
government (including the Veterans Health Administration) to conduct 
well-designed studies aimed at evaluating the various prevention and 
remediation strategies in use and identify best practices for 
prevention and remediation;

    4. Engagement with stakeholders to develop consensus on a set of 
national policies, standards and practices to reduce disease due to 
Legionella.

    (1) Tablan, O. C., L. J. Anderson, R. Besser, C. Bridges, R. 
Hajjeh, CDC, and Healthcare Infection Control Practices Advisory 
Committee. 2004. Guidelines for preventing health-care--associated 
pneumonia, 2003: Recommendations of CDC and the Healthcare Infection 
Control Practices Advisory Committee. MMWR. Recommendations and reports 
: Morbidity and mortality weekly report. Recommendations and reports / 
Centers for Disease Control 53:1-36.

                                  
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