[House Hearing, 111 Congress]
[From the U.S. Government Printing Office]
[H.A.S.C. No. 111-182]
FIGHTING SUPERBUGS: DOD'S RESPONSE TO MULTIDRUG-RESISTANT INFECTIONS IN
MILITARY TREATMENT FACILITIES
__________
HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON ARMED SERVICES
HOUSE OF REPRESENTATIVES
ONE HUNDRED ELEVENTH CONGRESS
SECOND SESSION
__________
HEARING HELD
SEPTEMBER 29, 2010
[GRAPHIC] [TIFF OMITTED] TONGRESS.#13
U.S. GOVERNMENT PRINTING OFFICE
62-994 WASHINGTON : 2010
-----------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Printing
Office, http://bookstore.gpo.gov. For more information, contact the
GPO Customer Contact Center, U.S. Government Printing Office.
Phone 202-512-1800, or 866-512-1800 (toll-free). E-mail, gpo@custhelp.com.
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
VIC SNYDER, Arkansas, Chairman
JOHN SPRATT, South Carolina ROB WITTMAN, Virginia
SUSAN A. DAVIS, California WALTER B. JONES, North Carolina
JIM COOPER, Tennessee MIKE ROGERS, Alabama
JOE SESTAK, Pennsylvania TRENT FRANKS, Arizona
GLENN NYE, Virginia CATHY McMORRIS RODGERS, Washington
CHELLIE PINGREE, Maine DOUG LAMBORN, Colorado
NIKI TSONGAS, Massachusetts TODD RUSSELL PLATTS, Pennsylvania
John Oppenheim, Professional Staff Member
Thomas Hawley, Professional Staff Member
Famid Sinha, Staff Assistant
C O N T E N T S
----------
CHRONOLOGICAL LIST OF HEARINGS
2010
Page
Hearing:
Wednesday, September 29, 2010, Fighting Superbugs: DOD's Response
to Multidrug-Resistant Infections in Military Treatment
Facilities..................................................... 1
Appendix:
Wednesday, September 29, 2010.................................... 25
----------
WEDNESDAY, SEPTEMBER 29, 2010
FIGHTING SUPERBUGS: DOD'S RESPONSE TO MULTIDRUG-RESISTANT INFECTIONS IN
MILITARY TREATMENT FACILITIES
STATEMENTS PRESENTED BY MEMBERS OF CONGRESS
Snyder, Hon. Vic, a Representative from Arkansas, Chairman,
Subcommittee on Oversight and Investigations................... 1
Wittman, Hon. Rob, a Representative from Virginia, Ranking
Member, Subcommittee on Oversight and Investigations........... 3
WITNESSES
Collier, Col. James D., USAF, M.D., Assistant Surgeon General,
Health Care Operations, Office of the Surgeon General.......... 9
Hospenthal, Col. Duane, USA, M.D., Office of the Surgeon General,
Infectious Diseases Consultant................................. 6
Martin, Capt. Gregory, USN, M.D., Program Director, Infectious
Disease Clinical Research Program.............................. 7
Smith, Dr. Jack, Acting Deputy Assistant Secretary for Clinical
and Program Policy, Office of the Assistant Secretary of
Defense for Health Affairs..................................... 4
APPENDIX
Prepared Statements:
Collier, Col. James D., joint with Lt. Col. Michael Forgione. 63
Hospenthal, Col. Duane, joint with Col. Jonathan Jaffin...... 45
Martin, Capt. Gregory, joint with Judith F. English.......... 52
Slaughter, Hon. Louise McIntosh, a Representative from New
York, Committee on Rules................................... 31
Smith, Dr. Jack.............................................. 34
Wittman, Hon. Rob............................................ 29
Documents Submitted for the Record:
[There were no Documents submitted.]
Witness Responses to Questions Asked During the Hearing:
[There were no Questions submitted during the hearing.]
Questions Submitted by Members Post Hearing:
Dr. Snyder................................................... 77
FIGHTING SUPERBUGS: DOD'S RESPONSE TO MULTIDRUG-RESISTANT INFECTIONS IN
MILITARY TREATMENT FACILITIES
----------
House of Representatives,
Committee on Armed Services,
Subcommittee on Oversight and Investigations,
Washington, DC, Wednesday, September 29, 2010.
The subcommittee met, pursuant to call, at 1:30 p.m., in
room 2118, Rayburn House Office Building, Hon. Vic Snyder
(chairman of the subcommittee) presiding.
OPENING STATEMENT OF HON. VIC SNYDER, A REPRESENTATIVE FROM
ARKANSAS, CHAIRMAN, SUBCOMMITTEE ON OVERSIGHT AND
INVESTIGATIONS
Dr. Snyder. Good afternoon, and welcome to the Subcommittee
on Oversight and Investigations' hearing on the Defense
Department's efforts to monitor and control outbreaks of
multidrug-resistant infections that have occurred in military
hospitals over the past several years.
While the U.S. military has provided high-quality
healthcare for servicemembers wounded in Iraq and Afghanistan,
infection outbreaks caused by multidrug-resistant bacteria
emerged as a problem early on during military operations. One
of the pathogens with the most notoriety is Acinetobacter
baumannii--incidentally, any pronunciations are my own and any
resemblance to accurate pronunciations is clearly coincidental,
so--Acinetobacter baumannii, a group of opportunistic bacteria
which can accumulate antibiotic resistance relatively quickly.
The only treatments available to fight the infections, in some
cases, are highly toxic, older drugs that can cause harm to a
patient's health.
According to the DOD [Department of Defense], over 3,300
servicemembers developed Acinetobacter infections from 2004 to
2009. While the bacteria are found in the natural environment,
evidence suggests that the source of infections was in the
military hospitals. Contamination in these hospitals placed
other patients at risk. Outbreaks of multidrug-resistant
infections have created management challenges for the military.
Initially, the source of infections was difficult to
identify because wounded personnel are evacuated to several
treatment facilities before reaching a medical center in the
United States. Also, determining the nature and extent of the
problem took time because infections did not show up in
patients until days after injury, and screening and
surveillance capabilities were limited.
Moreover, implementing infection control and prevention
measures in combat hospitals are challenging given the physical
conditions and limited infrastructure available. The lack of
infection control expertise at these facilities, as well as
limited experience in treating multidrug-resistant infections
compounded efforts to manage outbreaks.
In the past few years, the number of infections in military
hospitals has decreased significantly, in part because the
total number of combat casualties has gone down, but also
because DOD and the services have implemented measures to
strengthen infection screening, control, and prevention in the
military healthcare system. Steps have been taken to promote
awareness of basic infection control practices such as using
new gloves and gowns with each patient. Guidelines for
isolating patients with suspected multidrug-resistant
infections and more targeted use of antibiotics were
implemented. Additional infection control training is now
available to deploying medical personnel. Furthermore,
standardized screening for multidrug-resistant bacteria has
been instituted at the major military medical centers.
Lastly, research has been conducted, which has led to a
better understanding of the risks and treatments associated
with multidrug-resistant infections.
While considerable progress has been made in controlling
infections, the problem has not been solved and new outbreaks
will be a continuing challenge. According to some service
officials, there is a need for (1) a more comprehensive
surveillance system to monitor infections; (2) enhanced
training and expertise in infection control; (3) a coordinated
and sustained approach in research and development; and (4)
perhaps an infection control consultant in each combat theater.
The incidence of drug-resistant infections is a national
and global problem in both the civilian and military world that
has grown dramatically over the past decade in civilian
hospitals. According to the Centers for Disease Control and
Prevention, almost 100,000 Americans are killed each year by
hospital-acquired infections. Health experts warn that the
problem could get worse in the next several years because there
are few new antibiotic treatments expected from the drug
research pipeline. Because patients with severe injuries are
most susceptible to these infections, DOD and the services must
remain vigilant in their efforts to monitor and prevent them.
The purpose of this hearing is to examine how the
Department of Defense has responded to outbreaks of multidrug-
resistant infections over the past several years and whether
effective surveillance, prevention, and research programs are
in place to manage this challenge in the future, and what
Congress can do to help.
That concludes my opening statement.
Congresswoman Louise Slaughter has had an interest in this
issue of multidrug-resistance for some years now. I would ask
unanimous consent to include as an addendum to my opening
statement, a statement from Representative Slaughter.
[The prepared statement of Ms. Slaughter can be found in
the Appendix on page 31.]
Dr. Snyder. And I will now recognize Mr. Wittman for any
comments he would like to make.
STATEMENT OF ROB WITTMAN, A REPRESENTATIVE FROM VIRGINIA,
RANKING MEMBER, SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
Mr. Wittman. Well, thank you, Chairman Snyder. And good
afternoon to our witnesses. Thank you so much for joining us
today and thank you for your service to our country.
You know, it is easy to start a debate or to find a
contrary view on almost every issue that arises here in
Washington. The good news is that the subject of today's
hearing is that rare exception to the rule. You know, there is
no political party, no healthcare provider and certainly no
patient that wants any part of infection, much less the
virulent infections that are the subject of today's hearing.
Multidrug-resistant organisms, or MDROs, are a serious
matter for both our military and civilian healthcare providers
and are with us to stay, I fear.
I understand that infection control demands constant
vigilance in medical facilities, requiring careful training and
strict adherence to proper procedures within all areas of
military treatment facilities. Infection control is
particularly difficult in an austere deployed setting with
limited supplies, limited access to fresh water, and the
necessity of handling potentially large numbers of casualties
who have been living in a field environment.
I traveled last spring to Afghanistan and after a single
day was covered in a significant layer of dust. So I can tell
you after moving through Kandahar Province, I have a deep
appreciation for what you all have to deal with downrange. And
I can only imagine the condition of troops living in the field
for months at a time, just based on my short experience there.
So I know infection control under such circumstances must
be daunting. And we are all glad to see that the growing
problem of Gram-negative bacterial infections in military
facilities was identified several years ago, and that
considerable progress has been made in screening for and
controlling these infections. In fact, the number of cases of
the most virulent bacteria was cut by almost two-thirds of
military facilities from the peak. My hat is off to you on
that.
Still, improvements can be made in enforcing infection
control protocols and reporting mechanisms and in research for
both the better treatment and better control procedures.
We on the committee fully support your efforts in this
area, and I look forward to hearing from you on how we can help
to continue to make progress in combating infections of all
types.
I look forward to your testimony today. And again, thank
you so much for what you have done. And thank you in the future
for what you will do in addressing this daunting issue.
And, Mr. Chairman, with that I yield back.
[The prepared statement of Mr. Wittman can be found in the
Appendix on page 29.]
Dr. Snyder. Thank you, Mr. Wittman.
Our witnesses today are Dr. Jack Smith, the Acting Deputy
Assistant Secretary for Clinical and Program Policy, Office of
the Assistant Secretary of Defense for Health Affairs; Colonel/
Dr. Jonathan Jaffin, Director, Health Policy and Services,
Office of the Army Surgeon General; Colonel/Dr. Duane
Hospenthal, Infectious Disease Consultant to the Army Surgeon
General and Chief of Infectious Disease Service at Brooke Army
Medical Center; Colonel/Dr. James D. Collier, Assistant Air
Force Surgeon General for Health Care Operations; Lieutenant
Colonel/Dr. Michael Forgione, Infectious Disease Consultant to
the Air Force Surgeon General and Chief of Medicine at Keesler
Air Force Medical Center; Captain/Dr. Gregory Martin,
Infectious Disease Consultant to the Navy Surgeon General and
Program Director of the Infectious Disease Clinical Research
Program at the Uniformed Services University of the Health
Sciences; and Ms. Judith English, Navy Bureau of Medicine and
Surgery Infection Control Consultant.
Thank you all for being here. We will--somewhere we have a
clock that you can see. We will turn the clock on for five
minutes. When the red light starts flashing, it means five
minutes have gone by. If you have more things to say, let us
know. Otherwise, we will get to our questions. We have seven
witnesses but only four of you actually are doing opening
statements. And we will begin with you, Dr. Smith.
STATEMENT OF DR. JACK SMITH, ACTING DEPUTY ASSISTANT SECRETARY
FOR CLINICAL AND PROGRAM POLICY, OFFICE OF THE ASSISTANT
SECRETARY OF DEFENSE FOR HEALTH AFFAIRS
Dr. Smith. Thank you, sir. Chairman Snyder, Ranking Member
Wittman, members of the committee, thank you for the
opportunity to discuss Department of Defense efforts to address
the growing challenge of healthcare-associated infections,
particularly those from multidrug-resistant organisms, or
MDROs.
We greatly appreciate the committee's interest in this
important issue and its continued strong support for the
dedicated men and women of America's Armed Forces.
Mr. Chairman, as the committee so well understands,
healthcare-associated infections, including those from MDROs,
are a serious problem for the military but also represent a
growing problem in healthcare facilities across the Nation.
These pathogenic organisms, which are predominantly bacteria,
have not only increased the length of hospital stays but also
mortality rates. So the problem is quite serious and one that
we must continue to address.
The sources of these bacteria and infections are
multifactorial with both environment and facility-related
factors. In hospital settings, they are most likely to
contaminate environmental surfaces, equipment such as
ventilators and dialysis machines, the hands of healthcare
workers, visitors and family members, and the respiratory,
urinary, skin, and gastrointestinal tracks and wounds of
hospitalized patients.
Accumulated data have shown that transmission of MDRO
infections in combat-wounded servicemembers who have returned
to the U.S. does not appear to have a single source or involve
a single strain of bacteria but, rather, are derived from
multiple sources and must be addressed as system issues.
DOD has been actively engaged in measures to screen,
surveil, prevent, and control infections in military treatment
facilities at home and on the battlefield. The military health
system maintains a quality assurance program implemented in all
military treatment facilities that establishes policies and
procedures and requires training of our personnel to minimize
the risk of infection to patients and staff, control the spread
of infection, assess patient care, review healthcare records,
and manage health resources and risk.
We have also established an Infection Prevention and
Control Panel with service subject matter experts as a
subcommittee of our Military Health System Quality Forum. The
Global Emerging Infection Surveillance and Response System, a
division of the Armed Forces Health Surveillance Center, is a
central hub that leverages the surveillance and response assets
of the services and oversees military medical research units
and is paving the way for laboratory standardization for
microbes of military interest.
The Multidrug-Resistant Organisms Repository and
Surveillance Network System, established by the Medical
Research and Materiel Command, is working to rapidly
characterize emerging drug-resistant threats, track and monitor
MDRO patients, and reduce the risk of healthcare-associated
infections, which will aid in the development of a daily alert
surveillance system for MDROs of significant importance.
Since December of 2008, the military health system has been
participating in the Centers for Disease Control's national
healthcare safety network. Currently, 33 of our military
treatment facilities are participating. We are also
participating in the American College of Surgeons National
Surgical Quality Improvement Program, or NSQIP, which is
focusing on, among other issues, the occurrence of surgical-
site infections which could involve MDROs. And the Joint
Theater Trauma Registry is adding an infectious disease module
to study and better understand the risks, interventions, and
outcomes associated with combat trauma.
Standard infection prevention and control practices and
standard clinical practice guidelines have been established and
implemented in both garrison military treatment facilities and
deployed areas.
Admission MDRO colonization screening is performed at the
four major receiving military medical centers for OEF
[Operation Enduring Freedom] and OIF [Operation Iraqi Freedom]
wounded: Landstuhl Regional Medical Center, Walter Reed Army
Medical Center, National Naval Medical Center, and Brooke Army
Medical Center. Patients are not released from contact
precautions or isolation until they screen negative. And
screening results are collected, reviewed, and reported.
And DOD partnerships have been established with the VA
[Veterans Administration] and the CDC [Centers for Disease
Control] to address the challenges presented by MDRO and other
infections. In addition to screenings, surveillance,
prevention, and control, DOD has numerous studies underway to
further our understanding of MDRO and other infections to
enhance the prevention and control of infections and develop
new treatments and therapeutics. Several DOD research
laboratories receive funding to conduct research on MDROs,
including Walter Reed Army Institute of Research, U.S. Naval
Research Laboratory, U.S. Navy Medical Research Center, the
Institute of Surgical Research, the Armed Forces Institute of
Pathology, and the four major medical centers already
mentioned.
Mr. Chairman, the Department shares the committee's
concerns about the threat of multidrug-resistant organisms and
we are working to improve our preventive measures, treatment,
surveillance, and research as we respond to outbreaks of MDRO
and other infections in military personnel and facilities.
We appreciate the committee's interest in this important
issue and I will be happy to respond to any questions you may
have.
[The prepared statement of Dr. Smith can be found in the
Appendix on page 34.]
Dr. Snyder. Thank you, Mr. Secretary.
Colonel Hospenthal, I think you are next. You are
recognized.
STATEMENT OF COL. DUANE HOSPENTHAL, USA, M.D., OFFICE OF THE
SURGEON GENERAL, INFECTIOUS DISEASES CONSULTANT
Colonel Hospenthal. Chairman Snyder, Representative
Wittman, members of the committee, thank you for this
opportunity to discuss how the U.S. Army operates to prevent
and treat multidrug-resistant organism infections.
As you have already pointed out, multidrug-resistant
organisms have increasingly become a healthcare threat in the
U.S. and throughout the world. Focus in the U.S. and abroad to
control these infections has included attempts to prevent
transmission within our hospitals and other healthcare
settings. These efforts have been championed by the Joint
Commission through patient safety goals, and by the Centers for
Disease Control and Prevention through guidelines and the
prevention of MDROs.
Since the onset of Operations Iraqi Freedom and Enduring
Freedom, infections and colonizations with MDROs, especially
MDR Acinetobacter and the extended spectrum beta-lactamase
producing E. coli and Klebsiella, have complicated the care of
our injured U.S. military personnel. The source of these
bacteria in returning combat-injured personnel has not been
fully elucidated, but it appears that most likely these
bacteria are spread nosocomially, both in the combat theater,
along the journey back to, and within, military medical centers
in the United States.
In addition to routine practices and participation and U.S.
civilian healthcare standards, which I have mentioned, the
military healthcare system has responded to the problem with
specific efforts focusing on ameliorating the problem in
returning injured personnel. And these efforts include the
admission MDRO screening, which Dr. Smith has discussed;
development of specific guidelines to prevent infections in the
combat injured; efforts to improve infection prevention and
control in the combat theaters; establishment of an MDRO
repository and surveillance network; and enhanced research
efforts.
Admission MDRO colonization screening is performed, as
mentioned, in the four major receiving medical centers.
Patients are not released from contact isolation until they
screen negative. This provides near real-time monitoring in the
rates of this colonization and potential infections in
evacuated personnel to feed back to the combat theater.
Clinical practice guidelines, developed by a consensus
conference including the Army, Air Force, Navy, and civilian
personnel have been produced and promoted. These guidelines for
the prevention of infection after combat-related injuries have
focused on limiting antibiotic overuse and basic infection
control interventions in theater.
Critical review of infection control practices and
challenges in the combat theater hospitals was conducted by
myself and Colonel Helen Crouch in 2008 and 2009. These reviews
produced multiple interventions to improve our infection
control in a deployed setting. And this includes a renewed
emphasis and focus on basic infection control methodologies and
practices; development of electronic resources and Web pages;
deployment of clinical microbiology and antibiotic control; as
well as the establishment at the Army Medical Department Center
and School, a short five-day course for identified infection
control officers for deployed Level III hospitals.
Also a standardized infection control policy was produced
and is being staffed currently in the Afghanistan theater.
The repository established to collect and study MDROs was
established in June of 2009. The MDRO Repository and
Surveillance Network, the MRSN, was established to collect and
characterize bacterial isolates and provide epidemiological
data to manage this problem. In conjunction with clinical and
transportation data, the MRSN could help localize sources of
MDROs to enhance and focus infection control methods. And data
from the Joint Theater Trauma Registry will be essential to
this effort.
Over the past several years, the DOD has enhanced and
expanded research in the prevention and treatment of MDROs. The
Army is committed to aggressive efforts to prevent and treat
MDRO infections. This includes a commitment to continue
research aimed at understanding, preventing, and treating these
infections. Additional efforts are underway to prevent
transmission of MDROs within our military hospitals. We join
civilians and other Federal agencies in our commitment to
combat the spread of MDRO infections.
Thank you again for this opportunity to address the Army's
efforts. And thank you for your continued support to our
Nation's soldiers.
[The prepared statement of Colonel Hospenthal and Colonel
Jaffin can be found in the Appendix on page 45.]
Dr. Snyder. Thank you. Captain Martin.
STATEMENT OF CAPT. GREGORY MARTIN, USN, M.D., PROGRAM DIRECTOR,
INFECTIOUS DISEASE CLINICAL RESEARCH PROGRAM
Captain Martin. Chairman Snyder, Congressman Wittman,
distinguished members of the subcommittee, I am pleased to have
the opportunity to update you on Navy Medicine's response to
the problem of multidrug-resistant organisms.
As the Navy Surgeon General specialty leader for infectious
diseases and a practicing infectious disease physician at
Bethesda Naval Hospital, I can assure you this issue is vitally
important to the Vice Admiral Adam Robinson and to all of Navy
medicine.
One only has to listen to NPR [National Public Radio] or
watch the evening news to understand that the threat from
multidrug-resistant organisms has really become a global issue.
The Infectious Disease Society of America, the Institute of
Medicine, and the World Health Organization have all identified
resistant infectious agents as major public health threats for
which a coordinated global effort is urgently needed.
The DOD has been a national leader in identifying and
addressing the MDRO challenge. While focused on the combat
injured, many of whom have survived overwhelming blast injuries
with burns and amputations, the reality of treating these
infections has been sobering. In some cases, MDRO infections
have been responsible for persistent infections, leading to
delayed healing, amputations, or sepsis.
MDRO infections in our combat injured were first identified
in 2003 on the hospital ship Comfort and at Bethesda. The Naval
Hospital began screening of OEF/OIF patients for MDROs and
instituted infection control measures to prevent their
acquisition and transmission among patients and staff. Bethesda
screening was then adopted in each of the major casualty
screening centers in the U.S. and in Landstuhl.
Our Army colleagues deployed an expert team to treatment
facilities in theater to assess infection control measures and
ensure that standard precautions were being adhered to, even in
forward treatment areas. Their efforts led to changes in
practice in all three services with cohorting of long-term
patients separately from the acutely injured patients who were
unlikely to harbor MDROs and were typically being MedEvac'd
back to Landstuhl and CONUS [continental United States] Army
and Navy facilities.
Furthermore, infection control training needs were
identified and a predeployment infection control course made
available to each of the services.
The establishment of the MDRO repository and surveillance
network to collect isolates will enable a more definitive
molecular analysis of the relationships among the MDROs, as
well as common sources for their acquisition. As our patients
transfer between hospitals of the different services, all DOD
MTFs [Military Treatment Facilities] will benefit from the
repository system.
Most importantly, our patients, their families, and our
clinicians would like to know what can be done to limit the
harm these infections inflict on our wounded warriors. In this
regard, Navy BUMED [Bureau of Medicine] has funded the Trauma
Infectious Disease Outcome Study, or TIDOS, to combine
surveillance, laboratory, and clinical data from combat-injured
patients and follow them through their subsequent care in VA
hospitals.
The DOD is uniquely capable to develop a program like TIDOS
that can monitor a large group of patients and develop
evidence-based recommendations that will be utilized not only
in the care of an injured marine from Afghanistan but also the
high school student with an infection after a car accident.
In the last few weeks, the TIDOS project has expanded to
include the VA hospitals, and is now one of the first medical
programs to bridge the military to the VA transition. We are
enthusiastic that TIDOS will provide the data to assess our
treatment of combat-related infections and effect changes in
practice that will improve future outcomes.
Overall, I feel the response of the DOD infectious diseases
and infectious control communities to the worldwide threat of
MDROs is something we should be proud of. Careful surveillance,
coordinated interventions, and increased research efforts are
helping the Navy and the DOD to remain at the forefront in the
response to MDROs.
I appreciate the opportunity to have updated you on our
efforts and look forward to your questions. Thank you.
[The prepared statement of Captain Martin and Ms. English
can be found in the Appendix on page 52.]
Dr. Snyder. Thank you, Captain Martin. Colonel Collier.
STATEMENT OF COL. JAMES D. COLLIER, USAF, M.D., ASSISTANT
SURGEON GENERAL, HEALTH CARE OPERATIONS, OFFICE OF THE SURGEON
GENERAL
Colonel Collier. Chairman Snyder, Representative Wittman,
good afternoon and thank you very much for this opportunity to
discuss this critical issue with you today.
The Air Force is working diligently with our sister
services to control infectious diseases in theater and in our
medical treatment facilities. As you are well aware, this
problem continues to challenge the medical community in both
the public and private sectors around the globe. And we
appreciate your support in our endeavors to address it.
As I am the last to speak, I will try not to be redundant
to the previous witnesses, and have submitted my full statement
for the record.
In response to the challenge of treating and managing MDRO
infections in our returning servicemembers, the DOD has
instituted coordinated Tri-Service efforts in the areas of
infection control and prevention, in surveillance, and in
research and development.
I will speak briefly about Air Force infection control
initiatives. The Air Force is committed to infection control
throughout our continuum of care. The most common patients in
our Air Force theater hospitals to develop MDRO infections are
those who remain in intensive care units for extended periods
of time. Active Duty ICU patients are stabilized and sent to
Landstuhl Regional Medical Center or CONUS hospitals as quickly
as possible.
In contrast, injured and ill host-nation patients have very
limited resources for long-term medical care within their
country; thus they tend to stay longer in our theater
hospitals. This population is the one most susceptible to MDRO
infection and colonization.
Our theater hospitals have a physician and nurse as the
infection control officer and representative to provide ongoing
oversight and promote continuing awareness of infection control
standards. They conduct surveillance, provide educational
briefings on antibiotic-resistance issues and wound management,
and emphasize basic infection control efforts to prevent spread
between hospitalized patients throughout the deployment
rotation.
The Air Force also has a specific package, the
expeditionary infectious disease team, which is available to
provide dedicated infectious disease and infection control
assets for the theater surgeon. As the primary source of
patient transportation from theater hospitals to Landstuhl and
back to and throughout CONUS, air medical evacuation [AE] is
the linchpin of our healthcare continuum.
Our AE crews are trained annually in infection control. In
addition to the usual standard precautions, crews are trained
to mitigate the risk of transmitting nosocomial infections in
the operational environment. They are trained to disinfect
equipment and have in-flight kits that contain both spill kits
and personal protective equipment. Further, hand sanitizers are
placed throughout the aircraft cabin. AE personnel are also
educated about airflow in our different air frames and where
best to position patients to avoid the spread of infection.
The Air Force has formal infection control courses that are
conducted at Sheppard Air Force Base in Texas. There are three
levels of training provided: for those assigned to infection
control positions, both officer and enlisted on the active duty
side; for those assigned as the infection control function and
committee chairperson; and training specific for our reserve
component members.
We also utilize equivalent civilian infection control
courses. The new draft of our Air Force instruction, entitled
``Infection Prevention and Control Program'' has added an
optional element, which suggests that an active duty officer
serve as an infection control assistant and rotate through the
infection control office in those facilities that have a
civilian infection preventionist assigned. This is designed to
facilitate actual hands-on management of the infection control
program in garrison for active duty officers so they may gain
experience prior to deploying.
While none of our Air Force MTFs consistently receive
combat-injured U.S. personnel at this time, our medics do
practice in all of the major MTFs responsible for the care of
these patients, which include forward-based hospitals and, as I
mentioned, in our air and medical evacuation system.
An MDRO colonization screening process of OIF and OEF
wounded, upon admission, is now in place; and, encouragingly, a
recent review of this data has shown a significant decrease in
the number and percentage of patients colonized with
Acinetobacter upon arrival at Landstuhl and the three Level V
CONUS facilities.
While much remains to be done and understood to control or
eliminate this complex medical dilemma, we continue to work
with the world's foremost infectious disease experts to find
the answers that will prevent future patients from contracting
an infectious disease from others in the very environment
designed to protect and heal them.
Whether they are our military and family members here in
CONUS or our wounded warriors in theater, we must find a
solution to this constantly evolving challenge.
We appreciate your support, Mr. Chairman, and that of the
committee as we seek to achieve this daunting but critical
goal. Thank you.
[The prepared statement of Colonel Collier and Colonel
Forgione can be found in the Appendix on page 63.]
Dr. Snyder. Thank you all. I thank you all for being here.
Colonel Collier, I think you were the only person brave
enough to try your own pronunciation of Acinetobacter. So we
applaud you for that. You know--well, Mr. Wittman, I will put
ourselves on the 5-minute clock, whoever the timekeeper is
here.
When you think about what this means for families and
individuals who have been wounded, moved to a military facility
in country, moved to Landstuhl, come back to the United States,
get put into one of our military hospitals, have family members
probably down there by then, and then to develop one of the
infections and have things go south very rapidly, it must be
just heartbreaking not only for the family but also for the
healthcare providers that are trying to take care of this
person.
And, Dr. Smith, I will ask you the question but then I will
let you defer to whoever you want to. I would like a little
tutorial, if I could get one, on IED [improvised explosive
device] injuries, and if the fact of a blast effect, in
addition to an open wound, how that--if that is a factor in
these infections.
Dr. Smith. Well, sir, I am certainly not an expert on IED
injuries. But as we all know, they have become quite a problem
for us in DOD during the course of this war. I believe we do
have Colonel Hospenthal who could perhaps respond to that.
Colonel Hospenthal. Sure. I mean, certainly the blast
injuries from IEDs cause tremendous tissue damage and
devascularization. Initially when we were looking for a source
of these MDROs, we were concerned whether there are--some of
the bacteria in the soil and organic debris were actually being
lodged up in organic fragments and such. And so certainly it
doesn't look like that is the main cause of these MDRO
infections, but certainly the damage is. The damage that is
caused there has to be carefully debrided while trying to save
tissue, and so devitalized tissue may need the--the surgeons
may need to go back multiple times to try to debride off the
dead parts of the tissue, to allow the vascularized surviving
tissues to survive, all during the while there is pressure
from--or colonization with bacteria, like we have bacteria
always on our bodies. And in the hospitalized environment,
these bacteria are all off in these multidrug-resistant
bacteria that then colonize these wounds and can cause the
infections that we see.
Dr. Smith. And, Colonel Jaffin, you have some comments
concerning this.
Colonel Jaffin. Sir, I guess I am the only surgeon at the
table. But what we see, especially with the large blast
injuries, is a lot of separation of tissue along the tissue
planes, that there is disruption of the vascular supply leading
to large amounts of tissue. And so in order to minimize
deformity and dysfunction, we try and preserve as much of that
tissue as we can.
At the same time, we are caught trying to make sure that we
remove all of the tissue that is not viable. That nonviable
tissue is a great culture medium for any organism. And that is
why the importance of the drug--of the infection control
measures to prevent colonization with the multidrug-resistant
organisms.
Dr. Snyder. In terms of the availability of research
dollars, you all have your own budgets, and we have a lot of
activity going on with NIH [National Institutes of Health]. I
don't have a sense of the adequacy of research dollars
available to you all for looking at this issue. Is it adequate?
Is it inadequate? It seems like it actually went down over the
last couple of years. This is in the area where Congress can
help. If we are not doing our job, you won't have adequate
research dollars.
Dr. Smith or anyone else want to comment?
Dr. Smith. Yes, sir. I will begin with what is budgeted at
the DOD level. We have currently in this fiscal year $13.68
million allocated for studies related to multidrug-related
organisms or multidrug-resistant organisms--I am sorry--$10.25
of that in antimicrobial countermeasures and $3.43 of that in
wound infection prevention and management. And the other--the
services do allocate some research dollars I believe as well to
MDROs and infectious-disease issues. And I will let the
services speak to those.
Dr. Snyder. I think that is your cue.
Dr. Smith. Do you have figures for Army, MIDRP [Military
Infectious Diseases Research Program] or----
Colonel Jaffin. I can probably take that, sir. For MIDRP,
there is about $430,000. For the specific on wound infections,
there is $895,000. U.S. Navy wound infection research also gets
money. I don't have the exact number right here. USUHS
[Uniformed Services University of the Health Sciences] has a
little over $4 million. For congressional special interest
projects on wound infection, there is almost $12 million. SBIR
[Small Business Innovation Research] project is about $3.7
million.
Dr. Smith spoke about the Defense health programs and then
war supplemental intermural projects, there is about another
$2.5 million, sir.
Dr. Snyder. Anyone else have any comment?
Dr. Smith, I thought that the upcoming year--you said out
of the current fiscal year--I thought the upcoming estimate is
actually going to be a drop of several million dollars, from
almost $14 million; is that correct?
Dr. Smith. Sir, I don't have figures for fiscal year 2011
or beyond at this point. It is my understanding that money has
been programmed for this area of research. And in addition to
that, there is incremental funding of programs in the outyears.
So that if there is promising research that has been identified
and is ongoing, then that is often funded in the year of
execution.
Dr. Snyder. In your opening statement, you described that,
Dr. Smith, as vigorous research funding. It doesn't seem
incredibly robust to me. Am I wrong? I mean, it seems like this
is a huge problem; it is a huge national and international
problem. You have got major facilities around the world. It
seems like that money would be stretched out pretty thinly,
pretty rapidly. Is that a fair statement?
Dr. Smith. I am not sure that I used the ``vigorous
funding,'' sir, when--in my statement.
Dr. Snyder. I think you said ``vigorous research.''
Dr. Smith. We certainly do have funding allocated for
research. And this is very definitely an important, a vital
area of interest for the military. But as you pointed out, it
is also a national problem and we are collaborating with,
coordinating with the National Institutes of Health and other
organizations that are devoting research dollars to this. We do
have to balance our research funding in this area with other
areas of military research interest. So it is in a competitive
process. But as I say, we have $13.6 million for this year.
Dr. Snyder. I think your opening statement on page six says
the DOD has a vigorous research program. And around here when
we hear ``vigorous,'' we automatically think of funding, I
guess.
Mr. Wittman, I went over my time. Mr. Wittman.
Mr. Wittman. Thank you, Mr. Chairman. I will begin with Dr.
Smith, and I would like to get the perspective, too, of the
other folks here from the different service branches. I want to
focus on the element of training and the element of deployed
infection control officers downrange.
First of all, I would like for you to give us an overview
about the scope and breadth of training that our infection
control officers receive and our infection control personnel
receive and our medical care personnel receive. Both in a
deployed situation and back stateside; and then also to
determine how are those individuals deployed downrange? What
mixture of personnel do we have there? Is there a specifically
assigned officer in charge of infection control at these
medical care facilities downrange? Who are those personnel? I
understand in the past that there were nurses that were
assigned as infection control officers. Is that still the case?
If you could tell us a little bit about the extent of
training and then how those individuals are deployed in our
medical care facilities.
Dr. Smith. Yes, sir. Well, I will begin with the policy
level and work down probably as far as the stateside
facilities, and then pass it to my service colleagues to speak
a little bit more about the deployed environment.
But, of course, infection control is an element of the
training of all medical professionals now. So our physicians,
our nurses, our corpsmen, our technicians, are all being
trained in their basic professional training about infection
control.
There also is Joint Commission accreditation of our
inpatient facilities and we have ambulatory accreditation of
our outpatient clinics which have initiatives focused on
infection control. Infection control programs are a requirement
for accreditation in those. And along with that goes
appropriate training and orientation of staff in the facility-
level infection control programs.
I do know that in the predeployment setting, DOD is also
providing some additional training for personnel, but would
urge that we keep in mind that the people who are deploying
into the operational setting are the same people who have been
providing the care back in the medical treatment facilities.
So certainly the professional, fundamental training, the
infection control specific training that they are getting and
utilizing every day in our military treatment facilities is
useful as they deploy to that operational environment. And
there has been pointed out in some of the testimony some of the
challenges of practicing good infection control procedures and
prevention in that austere environment. That is very definitely
a critical factor.
But let me pass to my left and ask whether the services
would like to comment on the deployed environment.
Colonel Hospenthal. I would agree with everything Dr. Smith
has just stated. Certainly as medical healthcare professionals,
we all receive nearly continuous training in infection control
because it has become such a big issue throughout the world.
In the deployed setting, certainly all the medical
personnel have been working in hospitals and do have the basic
training. Our mission in 2008 to review infection control
practices and challenges revealed that there really weren't
well-trained, dedicated infection control officers in charge of
the program at the Level III facilities. It wasn't that the
personnel weren't doing infection control or weren't doing a
pretty good job, but the infection control officers that we
have seen downrange really had not had more training and
additional training. And often they were nurses, and often they
really didn't have dedicated time to do their infection control
officer duties.
And that is really the challenge that we identified and
focused on over the last several years: developing the kind of
just-in-time five-day infection control officer course and in
getting policy changed on the Army side to stress infection
control.
Recently there was an EXORD [executive order], actually
this week, that went through that makes it a requirement that
as the CSH is--as the Combat Support Hospital breaks into
separate pieces, rather than operate as one single unit, that
each one of those pieces or slices as we call them that have
inpatients have an infection control officer who has been
trained in either our five-day just-in-time course, or who has
experience.
And I believe this problem has really developed because of
the operational tempo. We have a lot of hospitals downrange. We
have been there a long time, and these hospitals are not
operating as a single CSH. They are broken into multiple
segments. And because of that, we just did not have enough
infection control officers trained throughout this.
Captain Martin. I really have to defer to my two previous
colleagues because I think most of what they said really refers
to all of us. Since all of these in-theater hospitals are
really Tri-Service, we talk constantly. I mean, I am on a
constant first-name basis with all of these guys; and we know
what is going on, who is going where, and we have a pretty good
handle on the issues.
I think, as Colonel Hospenthal just brought up, earlier on
in the war things were a little less organized as far as what
we knew was going on. And now the focus on infection control is
much more evident at all of these facilities, both in CONUS and
OCONUS [outside the continental U.S.]. So I think that we are
really--have a much better handle on ensuring that infection
control practices--standard practices are being met, even at a
much more forward setting than we had previously.
I also have with me Ms. Judy English, who is your Navy
infection control leader consultant. And any comments about
specific things that you would want to bring up from--she is an
infection control nurse, and I think she is one of the only
nurses we have in here. And it has been an important thing for
Judy to be at BUMED because I think it emphasizes just how
important infection control is to the Navy both in CONUS and
OCONUS.
Ms. English. Thank you. Thank you, sir.
The Navy infection prevention and control arena has been
trying in CONUS to civilianize. So that at this point in time,
68 percent of our infection preventionists are civilians. And I
have a monthly video teleconference and digital conference
online that is two times in the day, so people all over the
world can sign on. And this is for management and education
purposes. And we do this continuously, as well as the usual
getting together.
We are also working with the Army and the Air Force as
members of the TMA [TRICARE Management Activity] Infection
Prevention and Control Panel. And we are now going over the
data that Army, Navy, Air Force are all entering into the CDC's
National Health Care Safety Network relevant to central line-
associated bloodstream infections and ventilator-associated
pneumonias in babies through the elderly in critical care.
And now the Navy is working with the Navy-Marine Corps and
Public Health Center with beta testing sites to document all
MDROs that are in CHCS [the Composite Health Care System], so
that as soon as the Centers for Disease Control can accept HL7
[Health Level 7] download of these data, the entire Navy MTFs
[medical treatment facilities] and DTFs [dental treatment
facilities] will immediately go into downloading all of the
MDROs, working with DOD and CDC. And this will be another
benchmark data that is not as high as the pulsed-field gel
electrophoresis that is going on. But this is the best that we
can do without higher technology. This will be a 21st-century
technology download as soon as CDC can accept these data.
Colonel Collier. Thank you. I think in the Air Force we
mirror our sister services in our in-garrison performance,
although, because of the small size of most of our facilities,
it is a dual-hatted position. Downrange, we also dual-hat it,
but those personnel have to have passed the training level
required of an infection disease preventionist to get that
position in our downrange hospitals.
The only additional place where we carry out additional
training then is our air medical evacuation business. And the
air medical evacuation crews do receive additional training in
order to understand how that works on an otherwise dirty
airplane.
So, yes, sir, thank you.
Dr. Snyder. Thank you, Mr. Wittman.
Maybe I will start with you, Colonel Collier, and go the
other way, or maybe you can speak for the whole group. But in
terms of the development of new drugs--I mean, those are
expensive research projects to try to come up with a new drug.
How much are--is the military or military patients involved in
research looking for the next generation or a new kind of drug
to deal with these infections?
Colonel Collier. Sir, I am not able to answer that
question, but I would ask my colleague if he has some input.
Colonel Forgione. Thank you. As far as the Air Force's
position in that, we do participate in clinical trials through
the Infectious Disease Clinical Research Program that is stood
up at USUHS and is NIH-collaborative as well. And so we do
occasionally have patients that will participate in large
multicenter trials. As far as a direct research initiative in
the Air Force looking for new drugs, we do not have that
service at this time.
Captain Martin. This is kind of a difficult question
because the DOD is not really set up well to develop new
antimicrobial agents. That is really probably such an expensive
and difficult undertaking that ``Big Pharma'' is really the
only ones with pockets deep enough and with the ability to
develop a lot of new antimicrobial agents. Whereas the DOD,
especially the Army, has developed all the anti-malarials we
have, and we have a pretty good system for looking at that.
It would really not be in our best interest for the DOD to
start looking at the very basic science needed to do a lot of
the regular antimicrobials. So what we have done, I think, is
focus more on some of the things that we can work on. And that
is the clinical side of it.
So we are doing some testing on some agents that are not
approved in the United States now that have been funded, some
Japanese products, and some other drugs that are really second-
and third-line drugs we are using for some of these. We are
looking at doing some studies with those clinically.
I think the more important thing is that we are able to
collect a lot of these different isolates. We are allowed to.
With our repository services and whatnot, able to molecularly
characterize these. And then when other universities that have
the ability to do this ask for isolates, we are able to send
them out. We are able to send a lot of multidrug-resistant
Acinetobacter isolates out because we have a large collection
of them, because we have been able to hold them. And these are
clinical isolates that they actually need.
So we partner with a lot of our civilian organizations. Dr.
Smith talked about a lot of the funding. A lot of that funding
actually goes out to civilian universities to do studies that
we are really not equipped to be able to do. We are trying to
focus more on the clinical end of things and directly with
patients.
Colonel Jaffin. Mr. Chairman, one of the things that we try
and do in DOD medical research is we try and target those areas
that the civilian sector is not targeting. There is an
extensive, and has been mentioned, an extremely expensive
program in Big Pharma to look for new antimicrobials. We have a
few agents that we are looking at, some polypeptides and things
like that.
But the main focus is to partner--to try to expand the
indications for the new agents that a pharmaceutical company
may be working with to try and target the specifically
difficult organisms or organisms that are not seen commonly in
civilian practice. And again, as Captain Martin mentioned, it
is that partnership and the working with Big Pharma and other
universities to enable to leverage our research dollars and our
research interests with theirs.
Dr. Smith. Yes, sir. And if I may comment, I agree with
what has been said by my colleagues to my left. There are a few
specific areas of research that DOD is pursuing that may have
some particular military usefulness with human albumin and
plastic coatings of orthopedic implants, predatory bacteria
microbial biofilms for the treatment of burns and wound
infections, and a look at Staph aureus [Staphylococcus aureus]
toxoids.
So I think what we do have is a need for collaboration,
coordination across many sectors, with DOD focusing on those
areas of particular military interests, sir.
Dr. Snyder. Do you think that the--you mentioned--I guess,
you, Colonel Jaffin, mentioned Big Pharma dealing with this
issue. Are you convinced that there is adequate research going
on in the private sector on resistant organisms? I mean, when
you start looking at a specific Gram-negative bacteria that has
resistance, the number of cases--it can be devastating to a
person, devastating to a hospital to have to deal with it.
Are the economics there to make it worthwhile for a company
to invest in that kind of research, not being sure you are
going to find a solution?
Dr. Smith. Sir, I am unable to comment on what Pharma may
be investing in.
Dr. Snyder. Well, we are talking about--you talked about
you thought you had a specific niche, implying that the rest of
it is over in the private sector. I am not convinced that there
is adequate research going on in this area, looking for the
next generation.
Colonel Hospenthal, do you have a comment?
Colonel Hospenthal. I mean, from the non-DOD side,
certainly the Infectious Disease Society of America which we
are--the three consultants are members of--have identified this
as a problem in getting new drugs, as has a similar counterpart
in the EU [European Union]. There isn't that many drugs in the
pipeline. I think----
Dr. Snyder. If I can interrupt. That is actually what led
to this hearing today, it was because, I don't know, sometime
in the last couple of years I became convinced that this is an
example where the military is inheriting a problem, whether it
is lack of foreign language skills or whatever it is, and you
are having to try to figure out how to solve it, but this is
going to be a tough one to solve.
The reason there is not adequate dollars in the civilian
side, is because it is going to take a huge amount of money to
find a new drug, or two or three, for a relatively small number
of cases, without much financial payoff. So then the question
becomes, well, should we actually be beefing it up, should that
perhaps be a role that we could play?
So I am interrupting you, but that is what led to this
discussion. Because I don't see them in the pipeline either.
Colonel Hospenthal. Well, because of the cost and because
of the Big Pharma story, we have chosen to focus really the DOD
research dollars on the wound, the colonization itself, the
biofilms that are in the wound that allow these bacteria to,
you know, survive and develop resistance.
So it isn't that we are not doing research on
antimicrobials. We mostly have focused on topical
antimicrobials in the wound, immune response in wounds, and how
can we make that--and a wound has to have bacteria in it. We
have bacteria all over our body. So how can we keep the numbers
of the bacteria down and not produce superbugs in those wounds?
That has been the focus that we have chosen with the research
dollars over the last several years.
Captain Martin. You know, I just want to add to that, as
you suggest, any microbial pipeline is really pretty empty. I
mean, we don't have many new things coming down the line that
look very promising for these really bad bugs. And as Colonel
Hospenthal said, we are able to look at some other things,
other than antimicrobials to treat these. And I think vaccines
have been a portion of it.
So we have a major problem with Staph aureus infections in
the military, especially in recruit settings, just because they
are common skin flora. And MRSA [Methicillin-resistant
Staphylococcus aureus], widely known all over, is a big problem
for us as well. So we are partnering with Pharma and looking at
Staph aureus vaccines and doing those trials actually in troops
in boot-camp type settings to see does this actually work in
our setting. What we need in DOD, not what we need in end-stage
renal disease patients in an ICU [incentive care unit]
somewhere, but what we need in DOD.
So there are other vaccine-type candidates. We have to look
at--something was mentioned a little bit about phage, where
viruses that will attack bacteria have been looked at. All of
these are important other avenues besides antimicrobials that
we are trying to pursue. And, again, looking at the clinical
end, where the science meets the patient; because that is what
we are having to deal with as the clinicians involved in caring
for these patients.
Ms. English. And this whole lack of medication. People
can't take a pill or have an IV [intravenous line] to kill the
bug that they have, that we got so used to over the last few
decades has brought us back to bedside care and scrupulous
adherence to standard precautions. And if anybody shows any
symptoms of something that might be contagious, we put a
barrier between the healthcare provider and those moist body
substances from the time they come back from overseas. And we
use a long-acting chlorhexidine gluconate that stays on the
skin for bathing these wounded warriors when they come back.
And we find out as soon as we can that they are colonized
or infected, so that we go back to basics to keep them as
healthy as possible and not to share their bugs among
themselves. It is real hard to keep marine buddies away from
each other when one of them is isolated and their buddy is in
an ICU and is not isolated. But you know, in special
circumstances, we have dressed up a marine dad so he could go
in to see his baby born when he had Acinetobacter, when he had
to do it on a video screen, and he and mom were able to know
that they were there for each other.
Dr. Snyder. Mr. Wittman.
Mr. Wittman. Thank you, Mr. Chairman. I think all these
different pieces of the issue are very interesting in how they
fit together and how we make sure that we are successful in the
end.
One of the critical elements, I believe, is the system of
surveillance; how do we look at reporting and tracking these
multidrug-resistant organisms; how do we do that in our medical
facilities?
And let me ask this. Can you all talk--and we will begin
with Dr. Smith--talk a little bit about the current
surveillance system? Is it adequate? What is it focused on? Has
it developed through the years?
I know that the Army, I believe, has a system of tracking
infections. I wanted to know a little bit about is that maybe a
model that should be used across all of our medical facilities?
And this is both downrange and deployed facilities and
nondeployed facilities back here stateside.
So just a little bit about that in looking at the Army's
multidrug-resistant organism repository and surveillance
network to see if that is maybe a paradigm that could be used
or what are the other services using as far as that effort to
track and keep up with these organisms and the infections that
go along with them?
Dr. Smith, I will begin with you and then I would like to
get the other panel members.
Dr. Smith. Yes, sir. Thank you.
I think we have--I would have to say we have a developing
system of surveillance. It certainly has gotten better and
better over time. And I mentioned a number of the elements of
that network of surveillance.
We are utilizing our Armed Forces Health Surveillance
Network. The Global Emerging Infections System is out there
gathering information from our overseas labs. We are
participating now in NSQIP, the National Surgical Quality
Improvement Program, which has a focus on infectious
complications of surgery. We are participating in the National
Health Care Safety Network through the CDC, which gives us part
of the picture. So we have a great deal of information that is
beginning to be available to us. And the NHSN [National
Healthcare Safety Network] and the NSQIP are relatively new for
us. We are still looking at how we utilize those data.
The services, as you have heard, do have some other parts
of that picture. But before I turn it over to them, let me say
that they participate in our quality forum, which is run across
service lines at the OSD [Office of the Secretary of Defense]
level. So we do have our Infection Prevention Control Panel
with the subject matter experts coming together to look at what
can we see, what do we identify as problems, and what do we
need to do about them in terms of both treatment, prevention,
further surveillance, and also the research picture?
So let me turn it over then to service representatives to
address their specifics.
Colonel Hospenthal. Well, this is certainly a huge problem.
And the biggest issue that I see that is difficult to actually
fix here is that if we had a single thing to track and follow
around this would be a whole lot easier. We could make it a
reportable thing, call it brucellosis, and things would be much
easier.
Even the CDC doesn't see this as something that is easy to
put your arms around, because there are dozens of genus of
these Gram-negative rods, there is probably 200 species of
these Gram-negative rods, and there are literally probably
thousands of different genetic elements that cause these
resistance patterns.
So if you put all of those combinations together, they are
hard to even decide what we are tracking and what we are
looking to track with surveillance methodologies. And so even
to pick out what we want to look for is difficult.
Certainly the Marine and Navy Public Health Center is
working this through the CHCS data, but it is very difficult.
CDC guidelines, because of this, really are to identify issues
at your own facility and individualize your response and
whether you conduct surveillance by doing cultures or by doing
syndromic versus diagnostic results.
Certainly because of this and because of the fact that a
lot of these don't even track by ICD-9 [International
Classification of Diseases, 9th revision] codes, there is not
an ICD-9 code for Acinetobacter, is one of the reasons that we
actually put together the standardized screening at Landstuhl,
National Naval, Walter Reed, and BAMC [Brooke Army Medical
Center] is just so we could have an idea of how many of these
Acinetobacters and how many of these other MDROs are coming
through the door from the combat theater, from Landstuhl as
they transfer into the U.S.
So with the MRSN [Multidrug-resistant Organism Repository
and Surveillance Network], the hope would be that this will
help provide some answers with some tracking data from the JTTS
[Joint Theater Trauma System] and JTTR [Joint Theater Trauma
Registry]. The MRSN is housed as an Army program currently, but
it has always been thought of as being a DOD program over the
long term. And certainly my Navy and Air Force colleagues were
involved and still are involved in running that program. That
program is based at the Walter Reed Army Institute of Research,
but it certainly gets National Naval Medical Center isolates,
Landstuhl isolates, et cetera.
Captain Martin. Just to add on to what Colonel Hospenthal
said, I think that this is also an issue of trying to track
these things where you don't know if a patient is colonized or
infected. We get asked how many of these you have. Well, do you
count the one that the same patient has had multiple times in
the lab over a long period of time? It becomes really difficult
to track.
We have been able to, and it was just alluded to through
the Navy and Marine Corps Public Health Center looking at the
CHCS computer system that is used DOD-wide, now able to really
look at the--they are trying to get all the hospitals to report
resistance the same way so they can look at this.
But this whole question about the recent superbug coming
out of India, NDM-1, we are asked how much of this are we
seeing in the Navy and Marine Corps? We are very quickly able
to go through and say, we are not seeing any of this; we
haven't seen any isolates of this. We could go through and look
at all of the stuff in the repository and say, there is not any
of this.
The study I talked about, TIDOS, the Trauma Infectious
Diseases Outcomes Study, is really collecting all of these
specimens from everybody, Army, Navy, Air Force. Even though it
has a Navy-funded program, most of the work is actually done at
Army hospitals. All of those isolates are collected, we are
able to save them and see what is going on, and have a pretty
good handle now, which we really didn't have five or six years
ago on what is going on with MDROs.
Ms. English. Infection control-wise, in the Navy and Army
for patients who have MDROs or some other epidemiologically
important pathogen, since the BRAC [Base Realignment and
Closure] is coming soon, Walter Reed and National Naval Medical
Center have become closer and closer, and we have devised
identical protocols. And we put, for bed management, if a
patient has ever had an MDRO, we have them listed. We note that
in AHLTA and/or CHCS [the patient electronic health record] so
the bed manager will note when they come back to the clinic or
as an inpatient and puts them on appropriate transmission-based
precautions. And this is communicated among the different
services, and as people are sent to San Antonio to go back
closer to home. But inside the Beltway is where this started.
We also devised a clearance culture protocol using the
Infectious Diseases and Infection Prevention people from Walter
Reed and National Naval Medical Center in congruence with the
Centers for Disease Control, because it is so hard to keep
people on isolation precautions when they feel better, they are
not dripping anymore. Do we have to stay here? Can't I go visit
my buddy? And we devised a protocol so that there are three
screenings, at least 72 hours apart, when the person has been
off all antimicrobial therapy for the bug for at least 72
hours. And this was agreeable to all three places. And that was
a first, to get people off isolation without having to wait
weeks or months.
Colonel Forgione. I think, as all the folks up here have
expressed, that this is really a process in evolution. And I
think we have some very good basic surveillance going and some
platforms that are going to help us to answer a lot of these
questions.
With these MDROs, it is a little different than some of our
tried-and-true reportable diseases, like tuberculosis, where we
have a very long history of managing this, very good guidelines
of how we do it, and it is all reported. I think we are still
defining what an MDRO infection is in some places and what
colonization versus true infection means.
And as the network that I think we have set up across the
services continues to evolve, we will be able to provide better
answers and then provide maybe guidelines out there that would
then better define exactly what these entities are and how to
address them.
Captain Martin. Sir, can I add one thing? Also not to toot
our own horns, but I think in infectious disease, infection
control communities in the DOD are probably one of the more
united groups of anywhere in medicine in the DOD. We cross-
train at Bethesda and Walter Reed. We are Army and Navy. In San
Antonio we are Army and Air Force. We swap staff around
frequently. We have a very good idea of what is going on.
And so when we talked about this before, it was hard for us
to separate out what we would do in each service, because we
really do this very much in a unified fashion, which I think is
the best way for our patients and the best way overall for the
way we want to go with this.
Dr. Snyder. And for the sake of our transcriptionist, that
``staff'' was with a double F, and not with a P-H kind of
thing.
I wanted to ask Ms. English, you talked very eloquently
about really getting in the prevention aspects of it. Have you
seen a difference over time, over the last several years, once
an infection has been diagnosed in terms of how well patients
have done as you have tracked that over the last six or seven
years, once they are diagnosed with an infection?
Apparently not a dramatic improvement.
Captain Martin. I think that is a tough question and I
think it is a very good question. I think that we are much more
sensitive to the fact that we have to be ready to treat an MDRO
right up front much more quickly. So we tend to collect our
samples and maybe more broadly treat with antimicrobial
therapies up front than we would have before, which may give us
a day or two jump on this before material comes back from the
lab.
And we also have a pretty robust discussion among ourselves
about how do you want to tackle this one. You know, this
patient has renal failure, and on top of it has this MDRO and
these other issues going on. Because these are tough, tough
clinical cases to handle very frequently.
So I think we are a little faster to be able to get that
together than maybe we were at first when we were a little more
shocked by these. I don't know if you have any comments to add,
Colonel Forgione, or----
Colonel Hospenthal. I would agree with that. We have also
made ourselves and our surgical colleagues aware that just
looking for bacteria because it might be there is not always
the best idea. So we do not swab wounds like we used to when we
first started thinking about Acinetobacter and just treating
the colonization. So we really have become more sophisticated
into only treating folks who clearly have infections. That way
we are not exposing our folks to some of these older and more
toxic agents.
Overall, I think patients are doing better. But that is my
anecdotal--my opinion. The TIDOS study certainly will give us
that data on how folks were treated, what works best. The
orthopedic groups in the military and across the civilian are
doing some larger studies for prevention with irrigation
pressures, irrigation fluids, irrigation additives for most of
these.
Most of these are traumatic extremity injuries. So there is
major funding for that research that is being done multicenter
and internationally. And I certainly think that data will help
us as well. We have developed prevention guidelines that talk
about peri-injury antibiotics, debridement, irrigation, et
cetera. That is a DOD, Army, Air Force, Navy program. We are
actually in the middle of revising those guidelines and doing
an update for prevention.
And I guess one side note, during all of this we noticed
that minocycline was actually an effective old drug for at
least the Acinetobacters. And we did work with the company that
actually owned the license for intravenous minocycline to get
it back on the market. It was never--it is still approved. It
is now available again.
Dr. Snyder. Colonel Hospenthal, I want to make sure I
understand what you are saying about the irrigation. On the
studies on the irrigation, are you saying that sometimes there
is inadequate irrigation in terms of cleansing, or you can
fire-hose it away to where you devitalize some tissue?
Colonel Hospenthal. Right. Probably the latter is more
important. I mean no one really knows how much irrigation fluid
to use. But is that really important? If you need to use it,
how much you need to get all the visible junk out of there.
More important is the pressure. There is a division among
surgeons, and in the literature, both basic research and animal
research and clinical trials, that high pressure is better
because these explosive IED blasts push things up in there and
we need to get them out so they don't become a nidus of
infection, versus high pressure is really only used to chisel
away at bones and take out bone marrow, and you shouldn't be
using high pressure and causing more tissue damage that then
might get infected. So trying to sort out which of those
actually is the better approach is being funded as a clinical
trial.
And then there is the debate, you know, naturally you are
thinking if I am pushing fluid up in there, wouldn't it be
better to have some antimicrobial or antiseptic compound in
that fluid? Well, the research on that is all over the board as
well. A lot of the things that we would put in fluid to
irrigate actually kills bacteria, but it also kills growing and
granulating tissue. And so it may cause delayed healing that
then does get infected. So there are research projects into
looking at additives for irrigation fluid as well.
Dr. Snyder. I can't let you all get out of here today
without at least having you respond to the following question.
I had a discussion this morning with somebody who works on the
Hill, expressing their disappointment about going to the doctor
yesterday with about a day and a half of a cold, and the doctor
just flat-out refused to give them antibiotics. And this person
was incensed that that was the case, and probably was doctor
shopping.
Any one of you want to comment on the issue of the proper
use and overuse of antibiotics and its relationship to these
challenges you all are talking about today?
Colonel Jaffin. Sir, I think you have hit the--one of the
big problems around the world is that the expectation that
anything that you go to a doctor for needs antibiotics to cure.
We have aggressively taught that to all our healthcare
providers, all our healthcare team, that you only use
antibiotics when clinically indicated, and you use the most
specific antibiotic for that particular organism to prevent the
growth of drug resistance.
Captain Martin. I think it is a very, very interesting
question. And I have found kind of a dichotomy. That here in
the U.S., because people now have heard about the overuse of
antibiotics, in some people it has been easier to tell them you
don't need an antibiotic for this.
I think, as the Colonel just mentioned, the problem is in a
lot of the rest of the world--and I have lived and worked
overseas before in Latin America, and we are seeing this now
with the bugs coming out of India. A lot of the other world,
the rest of the world, you can just go and buy antibiotics. And
people frequently do, and take a day or two, or a dose or two
of all kinds of antibiotics.
So we see some of the most resistant bugs coming out of the
developing world, where you wouldn't expect that they would
have ready access to some of these, but they do. So we see
whether it is multidrug-resistant Salmonella infections out of
Southeast Asia or sexually transmitted infections. Big problems
with this. And a lot of it is inappropriate use of antibiotics.
I think we have a lot of inappropriate use in the U.S. still,
not nearly what we had before.
And the example you brought up is I think the most common
one. I mean, busy physicians who have six and a half minutes to
see a patient, sometimes it is easier to pull out the
prescription pad and give them what they want than it is to
talk them through the fact that they have a viral infection.
Ms. English. Excuse me. But on the other hand, this weekend
starts the 2010-11 flu season. And if your colleague had a
fever above 100.4 and upper respiratory symptoms, he would be
wise to consult with his primary care provider to receive
oseltamivir if he hasn't received his flu shot by now.
Mr. Wittman. Just one additional question. This is a little
bit in the weeds. But I noticed, Ms. English, you made
reference to pulsed field as one of the treatments. I know I
was intrigued by some of the research that is going on out
there with actually accelerating wound healing with that
technology. And I know that in my previous life in working in
public health, there was a lot of research there as far as food
safety, and having it as an antimicrobial agent in food
preparation.
But I would be interested to hear a little bit more from
you about the future of that technology and the applicability
there as far as infection control.
Captain Martin. I think there was a little confusion. What
she was talking about was pulsed-field gel electrophoresis
characterizing organisms, which is a different thing than what
you are talking about, which is also being looked at.
And in fact in the new hospital, the new Bethesda that we
are building, they are looking a lot at using some pulses of
ultraviolet and whatnot to knock down contamination in
operating rooms and in other rooms. So that is another moving
area that is really important, especially when you are talking
about organisms that are even becoming resistant to some of the
topical antimicrobials that we use. So that is ongoing research
as well.
Dr. Snyder. Thank you all for your time today, and thank
you for the work that you do. I will leave it as an open-ended
question for the record. If any of you have anything additional
you would like to add, please send it to the staff here in the
next week or so, and we will get it to the Members and also
include it as part of the record of this hearing.
I hope as time goes by, as you all continue your thinking
about these issues, if you see a further congressional role in
this, I hope you will let us know, because we would be very
receptive to doing what we can. If it is a funding need or
whatever it is, we would certainly be glad to look at it if you
see some additional needs there that are not being met that
Congress can play a role in.
Thank you all very much. The hearing is adjourned.
[Whereupon, at 2:51 p.m., the subcommittee was adjourned.]
?
=======================================================================
A P P E N D I X
September 29, 2010
=======================================================================
?
=======================================================================
PREPARED STATEMENTS SUBMITTED FOR THE RECORD
September 29, 2010
=======================================================================
[GRAPHIC] [TIFF OMITTED] T2994.001
[GRAPHIC] [TIFF OMITTED] T2994.002
[GRAPHIC] [TIFF OMITTED] T2994.003
[GRAPHIC] [TIFF OMITTED] T2994.004
[GRAPHIC] [TIFF OMITTED] T2994.005
[GRAPHIC] [TIFF OMITTED] T2994.006
[GRAPHIC] [TIFF OMITTED] T2994.007
[GRAPHIC] [TIFF OMITTED] T2994.008
[GRAPHIC] [TIFF OMITTED] T2994.009
[GRAPHIC] [TIFF OMITTED] T2994.010
[GRAPHIC] [TIFF OMITTED] T2994.011
[GRAPHIC] [TIFF OMITTED] T2994.012
[GRAPHIC] [TIFF OMITTED] T2994.013
[GRAPHIC] [TIFF OMITTED] T2994.014
[GRAPHIC] [TIFF OMITTED] T2994.015
[GRAPHIC] [TIFF OMITTED] T2994.016
[GRAPHIC] [TIFF OMITTED] T2994.017
[GRAPHIC] [TIFF OMITTED] T2994.018
[GRAPHIC] [TIFF OMITTED] T2994.019
[GRAPHIC] [TIFF OMITTED] T2994.020
[GRAPHIC] [TIFF OMITTED] T2994.021
[GRAPHIC] [TIFF OMITTED] T2994.022
[GRAPHIC] [TIFF OMITTED] T2994.023
[GRAPHIC] [TIFF OMITTED] T2994.024
[GRAPHIC] [TIFF OMITTED] T2994.025
[GRAPHIC] [TIFF OMITTED] T2994.026
[GRAPHIC] [TIFF OMITTED] T2994.027
[GRAPHIC] [TIFF OMITTED] T2994.028
[GRAPHIC] [TIFF OMITTED] T2994.029
[GRAPHIC] [TIFF OMITTED] T2994.030
[GRAPHIC] [TIFF OMITTED] T2994.031
[GRAPHIC] [TIFF OMITTED] T2994.032
[GRAPHIC] [TIFF OMITTED] T2994.033
[GRAPHIC] [TIFF OMITTED] T2994.034
[GRAPHIC] [TIFF OMITTED] T2994.035
[GRAPHIC] [TIFF OMITTED] T2994.036
[GRAPHIC] [TIFF OMITTED] T2994.037
[GRAPHIC] [TIFF OMITTED] T2994.038
[GRAPHIC] [TIFF OMITTED] T2994.039
[GRAPHIC] [TIFF OMITTED] T2994.040
[GRAPHIC] [TIFF OMITTED] T2994.041
[GRAPHIC] [TIFF OMITTED] T2994.042
[GRAPHIC] [TIFF OMITTED] T2994.043
[GRAPHIC] [TIFF OMITTED] T2994.044
[GRAPHIC] [TIFF OMITTED] T2994.045
?
=======================================================================
QUESTIONS SUBMITTED BY MEMBERS POST HEARING
September 29, 2010
=======================================================================
QUESTIONS SUBMITTED BY DR. SNYDER
Dr. Snyder. What does the Department of Defense need in order to
have sufficient surveillance capabilities to identify and monitor
multidrug-resistant infections throughout the military healthcare
system? Should the Army's Multidrug-resistant Organism Repository and
Surveillance Network (MRSN) be expanded to become a department-wide
capability? If so, what policy and resources are needed to make this
happen?
Dr. Smith. The Department of Defense currently has sufficient
surveillance capabilities to identify and monitor multidrug-resistant
infections throughout the military healthcare system. We do not believe
it's necessary to expand Army's Multidrug-resistant Organism Repository
and Surveillance Network to become a department-wide capability. When
necessary, we will consult Congress on the need for additional
resources and authority.
Dr. Snyder. Shouldn't MDROs be made reportable medical events in
DOD and service surveillance systems such as the Global Emerging
Infections Surveillance and Response System (GEIS)? Why aren't they?
Dr. Smith. Although including selected Multidrug-Resistant
Organisms as reportable events could have helped quantify the size of
the issue, TRICARE Management Activity's Infection Prevention and
Control Panel, which includes Service representatives and infectious
disease experts, felt that in most circumstances tracking the
infections was unlikely to affect the treatment and outcome for
individual patients because patterns are monitored and acted upon by
infectious disease and infection control practitioners among others at
the local level. The panel also felt that electronic systems would soon
be available (e.g., Multidrug-resistant Organism Repository and
Surveillance Network System) that can be mined to help answer questions
related to the size of the issue. The Department of Defense (DOD)
determines which medical events are included in the DOD Tri-Service
Reportable Events Guidelines only after reviewing recommendations from
the Centers for Disease Control and Prevention, the Council of State
and Territorial Epidemiologists, other public health organizations,
International Health Regulations from the World Health Organization,
and after soliciting advice from Infectious Disease experts throughout
the Department.
Dr. Snyder. What resources and policy are needed to provide
military treatment facilities, particularly those in deployed areas,
adequate standardized laboratory testing capabilities to identify and
characterize MDROs?
Dr. Smith. At this time, the Department of Defense does not need
additional resources and policies to standardize laboratory testing
capabilities to identify and characterize Multidrug-Resistant Organisms
(MDROs). We will consult and work with Congress if resources and policy
changes are necessary.
Dr. Snyder. Over the past several years military research and
development related to MDROs has been funded through several different
Department, service, and congressional programs and initiatives. Why
hasn't there been a long-term, stable funding source for MDRO-related
research? Is there a need for a more coordinated and sustained research
and development program (i.e., a program of record) focused on MDROs?
If so, who should be responsible for it?
Dr. Smith. There has not been long-term, stable funding for
Multidrug-Resistant Organisms (MDRO)-related research because in the
years immediately preceding Operation Iraqi Freedom/Operation Enduring
Freedom, there was no military medical research in the area of MDROs.
Military personnel who suffer combat-related injuries are at
significant risk of developing acute and chronic infectious
complications. Prior to 2008 and preceding Operation Iraqi Freedom/
Operation Enduring Freedom, there was no military medical research in
the area of MDROs.
In view of the fact that more in-depth research was required on
MDROs, DOD established an intramural program of research on wound
infections. In 2010 and subsequent years, the Defense Health Program
(DHP) has increased funding for medical research to address wounded
warrior focus areas to include wound infections. Research and
development activities sponsored under the DHP represent a long-term
sustainable program for preventing or inhibiting infection with MDROs.
Moving forward, the Department will ensure there is a coordinated
and sustained biomedical research and development program. To address
this, DOD has established the Armed Services Biomedical Research
Evaluation and Management (ASBREM) Committee. The ASBREM Committee
serves to facilitate coordination and prevent unnecessary duplication
of effort within DOD. The ASBREM is chaired by the Director of Defense
Research and Engineering and co-chaired by the Assistant Secretary of
Defense for Health Affairs. The ASBREM Committee includes Senior
Executive representatives from the Services, and acquisition
executives. Given the establishment of ASBREM, in future, it may serve
as an oversight committee for managing the research and development
focused on MDROs.
Dr. Snyder. What are the principal knowledge gaps and priorities
for military research and development related to MDRO infections?
Dr. Smith. The principle knowledge gaps and priorities for military
research and development related to Multidrug-Resistant Organism
infections include the following Defense Health Program-sponsored
activities in basic and applied research:
Basic research in wound infection prevention and management is
focused on the following knowledge gaps and priorities:
-- Identification and characterization of host immune response
biomarkers, particularly those predictive of infection, to aid
in clinical decisionmaking (e.g., optimal wound closure time);
-- Development of capabilities for early detection of
antimicrobial resistance and characterization of antimicrobial
resistance patterns in wound-colonizing and infecting
organisms;
-- Development of tools to detect and identify nosocomial
pathogens; and
-- Discovery of novel environmental treatments to prevent and/
or eliminate pathogen contamination from military medical
settings.
Basic research in antimicrobial countermeasures is focused on
the following knowledge gaps and priorities:
-- Identification and characterization of microbial virulence
factors and other potential therapeutic targets of metabolic or
signaling pathways associated with wound infection and biofilm
processes;
-- Identification of novel therapeutics (e.g., drugs) to
mitigate wound infection and biofilm processes; and
-- Discoveries applicable to polymicrobial infections and
topical treatment approaches.
Applied research in wound infection prevention and management
is focused on the following knowledge gaps and priorities:
-- Development of an in vivo model for polytrauma/blast wound
infection;
-- Identification and characterization of host immune response
biomarkers, particularly those predictive of infection, to
support clinical wound-management decisions (e.g., optimal
wound closure time);
-- Development of tools for early detection of antimicrobial
resistance and characterization of antimicrobial resistance
patterns in wound-colonizing and infecting organisms;
-- Development of tools to detect and identify nosocomial
pathogens; and
-- Development of novel environmental treatments to prevent
and/or eliminate pathogen contamination from military medical
settings.
Applied research in antimicrobial countermeasures is focused on
the following knowledge gaps and priorities:
-- Development of strategies to mitigate the action of
microbial virulence factors and other potential therapeutic
targets of metabolic or signaling pathways associated with
wound infection and biofilm processes;
-- Development of novel therapeutics (e.g., drugs) targeting
microbial virulence factors and/or other pathway components to
mitigate wound infection and biofilm processes;
-- Preference is for topical treatment therapies applicable to
polymicrobial infections, although novel treatment approaches
are also encouraged (e.g., chelators, antibody, phage,
antimicrobial peptides, quorum-sensing inhibitors, lysine, and
host immunoaugmentation including antibody); and
-- Preference is for projects with facile applicability for
advanced development leading to Food and Drug Administration-
approved products.
Dr. Snyder. According to the Navy's statement, coordination of
surveillance, treatment, and research efforts regarding infections in
combat injured has taken years to develop and is only in the last year
coming to fruition. Why did it take so long to achieve this level of
coordination? What ``lessons-learned'' are being implemented to prevent
future delay in similar situations?
Dr. Smith. The question is referring to the development of TIDOS
(Trauma Infectious Diseases Outcome Study) that has been developed at
the Uniformed Services University's Infectious Diseases Clinical
Research Program (IDCRP).
While we understand the congressional concern, the delay between
recognizing the problem and initiating a new program was not a failure
to achieve coordination among the Services. With the establishment of
the IDCRP in 2006, seed money from the National Institute of Allergy
and Infectious Diseases became available to initiate TIDOS. Shortly
thereafter, IDCRP investigators were able to demonstrate the critical
data that TIDOS would provide clinicians treating the war injured. Navy
Medicine provided funding for TIDOS in 2009 after the program's value
was properly assessed for its ability to generate evidenced based data
to improve how we deliver care. Adequate funding for TIDOS has been
planned through 2011.
We will continually review our efforts to fund clinical research
programs to best respond to emerging needs across the enterprise.
Dr. Snyder. DOD recently established a new research program--the
Wound Infection Research Program--which was funded at about $14 million
in 2010. Why is the Department only requesting about $2 million dollars
for this program in 2011?
Dr. Smith, Colonel Jaffin, Captain Martin, Ms. English, Colonel
Collier, and Colonel Forgione. When DOD established the Wound Infection
Research program in FY 2010, we did not have the multiyear funding
option to spread the cost over multiple years. Therefore, the upfront
cost in FY 2010 included two to three years' worth of medical research.
The FY 2011 cost reflects smaller adjustments we need to achieve long-
term research planning.
There has not been long-term, stable funding for Multidrug-
Resistant Organisms (MDRO)-related research because in the years
immediately preceding Operation Iraqi Freedom/Operation Enduring
Freedom, there was no military medical research in the area of MDROs.
Military personnel who suffer combat-related injuries are at
significant risk of developing acute and chronic infectious
complications. Prior to 2008 and preceding Operation Iraqi Freedom/
Operation Enduring Freedom, there was no military medical research in
the area of MDROs.
In view of the fact that more in-depth research was required on
MDROs, DOD established an intramural program of research on wound
infections. In 2010 and subsequent years, the Defense Health Program
(DHP) has increased funding for medical research to address wounded
warrior focus areas to include wound infections. Research and
development activities sponsored under the DHP represent a long-term
sustainable program for preventing or inhibiting infection with MDROs.
Moving forward, the Department will ensure there is a coordinated
and sustained biomedical research and development program. To address
this, DOD has established the Armed Services Biomedical Research
Evaluation and Management (ASBREM) Committee. The ASBREM Committee
serves to facilitate coordination and prevent unnecessary duplication
of effort within DOD. The ASBREM is chaired by the Director of Defense
Research and Engineering and co-chaired by the Assistant Secretary of
Defense for Health Affairs. The ASBREM Committee includes Senior
Executive representatives from the Services, and acquisition
executives. Given the establishment of ASBREM, in future, it may serve
as an oversight committee for managing the research and development
focused on MDROs.
Dr. Snyder. To what extent does the Department of Defense formally
coordinate and share information with the Department of Veterans
Affairs on the surveillance, prevention, and treatment of MDRO
infections? How is this done?
Dr. Smith. Currently, there are no formal coordination efforts
between the DOD and VA on the surveillance, prevention, and treatment
of MDRO infections. However, there are collaborative efforts underway
between the Department of Defense (DOD) and Department of Veterans
Affairs (VA) under the National Institute of Allergy and Infectious
Diseases/Uniformed Services University Infectious Diseases Clinic
Research Program which have established a long-term research protocol,
entitled ``Trauma Infectious Diseases Outcomes Study,'' to study
interventions and outcomes in our combat wounded who develop multidrug-
resistant organism (MDRO) infections. Patient recruitment for this
protocol began in June 2009.
Dr. Snyder. What does the Department of Defense need in order to
have sufficient surveillance capabilities to identify and monitor
multidrug-resistant infections throughout the military healthcare
system? Should the Army's Multidrug-resistant Organism Repository and
Surveillance Network (MRSN) be expanded to become a department-wide
capability? If so, what policy and resources are needed to make this
happen?
Colonel Hospenthal and Colonel Jaffin. The Department of Defense
should continue to maintain and strengthen established infection
prevention and control policy and practice at the local military
treatment facility (MTF), Service, and Department levels. Staffing and
support resources along with implementing policy are needed in order to
effect adequate identification and surveillance of MDRO infections
throughout the military healthcare system. The Army's MRSN could be
expanded throughout the Department to better coordinate and enhance
MDRO surveillance, characterization, and response.
Dr. Snyder. Shouldn't MDROs be made reportable medical events in
DOD and service surveillance systems such as the Global Emerging
Infections Surveillance and Response System (GEIS)? Why aren't they?
Colonel Hospenthal and Colonel Jaffin. MDRO infections are
currently tracked at the individual medical treatment facility level as
suggested by the Centers for Disease Control and Prevention (CDC) and
other professional organizations. As opposed to other reportable
diseases (e.g., cholera or measles), MDROs are an ill-defined group of
organisms. If MDROs were reportable the definition of an MDRO and the
diagnostic procedures would have to be constantly updated. The term
MDRO is chiefly used to discuss multidrug-resistant (MDR) Gram-negative
bacteria even though current CDC definitions include Gram-positive
organisms (e.g., methicillin-resistant Staphylococcus aureus (MRSA),
vancomycin-resistant Enterococcus (VRE)). MDROs potentially include
hundreds of individual species and resistance genes. Many of the
resistance mechanisms can only be identified by specialized laboratory
testing such as gene sequencing. Due to new resistance mechanisms and
predominant bacterial species continuing to emerge, Gram-negative MDRO
infections are not currently reportable events in U.S. civilian or
military sectors.
Dr. Snyder. What resources and policy are needed to provide
military treatment facilities, particularly those in deployed areas,
adequate standardized laboratory testing capabilities to identify and
characterize MDROs?
Colonel Hospenthal and Colonel Jaffin. Most military medical
treatment facilities (MTF) outside of the combat zones have adequate
capabilities to identify and characterize MDROs. The larger deployed
MTFs have been provided clinical microbiology assets and equipment.
Dr. Snyder. Since the outbreak of MDRO infections, what additional
infection control and prevention training and education do medical
personnel in deployed military treatment facilities receive? Please
describe the nature and extent of the training, what personnel are
required to take it, and where and how often it is provided. Are there
plans to expand infection control training and education?
Colonel Hospenthal and Colonel Jaffin. Additional infection control
training was added to the Joint Forces Combat Trauma Management Course
at Fort Sam Houston, Texas. This training is provided to personnel
staffing level III deployed medical treatment facilities such as the
Army's Combat Support Hospitals (CSHs). Additionally, a 5-day short
course was established to train Infection Control Officers who are
responsible for infection control programs within these hospitals.
Because a single CSH may split to operate in multiple locations, a
September 2010 Army Execute Order requires the CSH to assign an
Infection Control Officer at each location that provides inpatient
care.
Dr. Snyder. Do all deployed military treatment facilities have
trained and qualified infection control officers? If not, why? What
policy or resources are needed to ensure there is not a shortage of
military healthcare personnel trained and experienced in infection
control?
Colonel Hospenthal and Colonel Jaffin. Reviews of the combat
theater hospitals in 2008 and 2009 found that not all had trained and
qualified infection control officers (ICO). There is a shortage of
personnel trained and qualified to serve as ICOs at all deployed
medical treatment facilities (MTF). To remedy the shortage of qualified
ICOs, a 5-day short course was established to train personnel who are
responsible for infection control programs and have been identified to
serve as Infection Control Officers at the CSH. Because a single CSH
may split to operate in multiple locations, a September 2010 Army
Execute Order requires the CSH to assign an Infection Control Officer
at each location that provides inpatient care. Department of Defense
staffing policy should be revised to require trained and qualified ICOs
at all level III deployed MTFs (i.e., deployed hospitals).
Dr. Snyder. According to the Army's statement, critical reviews of
infection control practices and challenges in combat theater hospitals
were conducted in 2008 and 2009, which led to improved infection
control efforts. Are there plans to conduct such reviews on a regular
basis in the future? If so, who will conduct these reviews, how often
will they be conducted, and where will the results be reported to? If
not, what policy and resources are needed to establish this process?
Colonel Hospenthal and Colonel Jaffin. These reviews have been and
continue to be planned and conducted ad hoc by the Infectious Disease
and Infection Control Consultants to the U.S. Army Surgeon General with
the support of the U.S. Central Command (CENTCOM) Surgeon. The informal
plan is to continue these reviews on an annual basis with results
communicated to the CENTCOM Surgeon, the three Services Surgeons
General offices, and through presentations and publications to
deploying healthcare providers. These reviews will be conducted on a
routine and regular basis, ideally in conjunction with standardized
theater infection control practices and establishment of an infection
control theater consultant.
Dr. Snyder. What are the principal knowledge gaps and priorities
for military research and development related to MDRO infections?
Colonel Hospenthal and Colonel Jaffin. For military research and
development related to MDRO infections, principal knowledge gaps
existed in diagnostic and treatment products and programs have been
established to mitigate these gaps. Principal research priorities focus
on addressing knowledge gaps in addition to research on prevention
strategies and technologies. Programs established to address these
knowledge gaps and priorities include the Military Infectious Diseases
Research Program--Wound (MIDRP-W) and the Infections Diseases Clinical
Research Program (IDCRP). The MIDRP-W focuses on wound infection
research. The IDCRP, a joint program between Department of Defense
(DOD) and National Institutes of Health, focuses on the design, conduct
and publishing of collaborative clinical infectious disease research of
importance to the DOD and the National Institutes of Allergy and
Infectious Diseases through an effective research network that rapidly
responds to evolving infectious disease threats.
Dr. Snyder. According to the Navy's statement, coordination of
surveillance, treatment, and research efforts regarding infections in
combat injured has taken years to develop and is only in the last year
coming to fruition. Why did it take so long to achieve this level of
coordination? What ``lessons-learned'' are being implemented to prevent
future delay in similar situations?
Colonel Hospenthal and Colonel Jaffin. Since multidrug-resistant
Acinetobacter were first discovered as infecting patients on the United
States Naval Ship Comfort at the start of Operation Iraqi Freedom,
several ad hoc groups have helped to coordinate the Department of
Defense response to MDROs. This initial discovery and identification
did not include all MDROs, only Acinetobacter. The work and
coordination of these ad hoc groups have grown over the subsequent
years to what exists today. Implemented lessons learned include the
rapid identification and assessment of the class of infection along
with rapid dissemination of findings to other services and Department
of Defense infectious disease oversight organizations.
Dr. Snyder. What does the Department of Defense need in order to
have sufficient surveillance capabilities to identify and monitor
multidrug-resistant infections throughout the military healthcare
system? Should the Army's Multidrug-resistant Organism Repository and
Surveillance Network (MRSN) be expanded to become a department-wide
capability? If so, what policy and resources are needed to make this
happen?
Captain Martin and Ms. English. The collection of Multidrug-
resistant Organisms (MDROs) specimens from the National Naval Medical
Center Bethesda for the MRSN is already occurring and could be expanded
to other Navy military treatment facilities (MTFs). Most Navy MTFs have
an MDRO identification and surveillance capability and the Navy and
Marine Corps Public Health Center (NMCPHC) is expanding the central
monitoring of CHCS (Composite Health Care System) laboratory input to
eventually include all Navy MTFs.
Dr. Snyder. Shouldn't MDROs be made reportable medical events in
DOD and service surveillance systems such as the Global Emerging
Infections Surveillance and Response System (GEIS)? Why aren't they?
Captain Martin and Ms. English. No, the Centers for Disease Control
and Prevention (CDC) have not recommended tracking MDROs in this
manner. Diseases that are reportable are connected to individual
patients whereas MDRO isolates may be from clinical specimens,
colonization surveillance, environmental samples.
Data regarding the resistance profiles of bacteria are best
gathered in an antibiogram (spreadsheet describing the antibiotic
susceptibility of bacteria from a facility's microbiology lab that is
updated periodically). Collection and review of the data from Navy MTFs
on a regular basis allows for MDROs to be tracked more effectively. The
Navy and Marine Corps Public Health Center (NMCPHC) is tracking the
resistance profiles of bacteria at Navy hospitals electronically by
collecting data from the laboratory computer input into CHCS (Composite
Health Care System).
Dr. Snyder. What resources and policy are needed to provide
military treatment facilities, particularly those in deployed areas,
adequate standardized laboratory testing capabilities to identify and
characterize MDROs?
Captain Martin and Ms. English. Much of the initial identification
of MDROs can be performed with standard microbiology techniques (with
the addition of some commercially available test strips) and does not
require high-tech capacity. The ability to provide reliable data
regarding MDROs in the deployed areas requires a basic microbiology
laboratory, not only with the basic capabilities currently in place,
but also a trained microbiologist/micro lab tech to interpret the
laboratory data and guide further testing.
The provision of even a basic microbiology in a far forward-
deployed setting is often not possible. In these cases, identification
of MDROs could also be achieved by shipping the MDRO suspect isolates
on to Landstuhl Regional Medical Center or CONUS facilities where these
organisms can be more reliably evaluated.
Fully characterizing MDROs requires highly advanced laboratory
abilities and could not be done in the deployed setting and is best
performed at a centralized site such as that functioning with the
Multidrug-resistant Organism Repository and Surveillance Network
(MRSN).
Dr. Snyder. Since the outbreak of MDRO infections, what additional
infection control and prevention training and education do medical
personnel in deployed military treatment facilities receive? Please
describe the nature and extent of the training, what personnel are
required to take it, and where and how often it is provided. Are there
plans to expand infection control training and education?
Captain Martin and Ms. English. Infection Control is a universal
part of the training of all medical, dental and nurse corps officers as
well as hospital corpsmen. The Navy does not require special training
in infection control and has no specialized prevention training
specifically for those deployed, but does have several programs to
train Infection Preventionists (IPs). We have reemphasized basic
infection control in the deployed military treatment facilities and
requests for additional training, as needed, are strongly encouraged.
IPs in charge of infection prevention and control programs must
receive documented education in basic concepts of infection
surveillance, prevention, and control from an accredited program
providing continuing education credits. Navy Medicine holds monthly
video teleconference/digital conference online (VTC/DCO) meetings
hosted by the BUMED Infection Control Consultant. These sessions are
offered to all medical treatment facility/dental treatment facility
(MTF/DTF) IPs. They provide education on infection prevention/control
topics as well as updates related to current literature and Joint
Commission surveys.
Additionally, each MTF/DTF is encouraged to send IPs to current,
up-to-date courses. Examples include: EPI 101 (Fundamentals of
Infection Surveillance, Prevention and Control) courses by Association
for Professionals in Infection Control and Epidemiology (APIC); Courses
in Healthcare Epidemiology cosponsored by the Society for Healthcare
Epidemiology of America and the Centers for Disease Control and
Prevention (SHEA/CDC); Annual Fellows Course in Hospital Epidemiology
and Infection Control at the Johns Hopkins Hospital in Baltimore,
Maryland; the Statewide Program for Infection Control and Epidemiology
(SPICE) at the University of North Carolina at Chapel Hill.
Dr. Snyder. Do all deployed military treatment facilities have
trained and qualified infection control officers? If not, why? What
policy or resources are needed to ensure there is not a shortage of
military healthcare personnel trained and experienced in infection
control?
Captain Martin and Ms. English. All Medical, Dental, and Nurse
Corps officers along with enlisted Hospital Corpsmen have training in
infection control and infection control has been re-emphasized in all
Navy facilities as the increase in Multi-Drug Resistance Organisms
(MDROs) has occurred. There is not a specific designation for infection
control officers in the Navy. Military treatment facilities in deployed
settings assign a medical department officer to be responsible for
infection control. The hospital ships USNS Comfort and USNS Mercy, each
have assigned infectious diseases staff who are subject matter experts
in infection control, and other ships with a large medical department
may also deploy with an infectious diseases physician.
The Navy has not experienced a shortage of military healthcare
personnel trained and experienced in infection control.
Dr. Snyder. According to the Army's statement, critical reviews of
infection control practices and challenges in combat theater hospitals
were conducted in 2008 and 2009, which led to improved infection
control efforts. Are there plans to conduct such reviews on a regular
basis in the future? If so, who will conduct these reviews, how often
will they be conducted, and where will the results be reported to? If
not, what policy and resources are needed to establish this process?
Captain Martin and Ms. English. We are continually working to
improve how we deliver healthcare in all our medical facilities.
Continuously reviewing and revising how we do business helps us ensure
we are evaluating and implementing best clinical practices. The Army's
recent review of Infectious Disease and Infection Control was a good
example of how we have learned and adapted to conditions in-theater. It
was evident from the review that there was a need to reemphasize basic
infection control practices. This approach has had a positive impact
for not only our patients in-theater, but also for those in CONUS. In
addition to our renewed emphasis on basic infection control, the Navy
and Marine Corps Public Health Center (NMCPHC) is electronically
tracking the resistance profiles of bacteria at Navy Military Treatment
Facilities. Navy Medicine will continue to conduct additional reviews
as appropriate and in collaboration with our partners in-theater.
Dr. Snyder. What are the principal knowledge gaps and priorities
for military research and development related to MDRO infections?
Captain Martin and Ms. English. The principal gap in MDRO-related
research is the lack of available drugs in the development pipeline to
effectively treat these infections. This problem is not specific to the
military as it affects civilian facilities worldwide. The need for an
international focus on development of new drugs for these infections is
outside the research capabilities in the U.S. military at this time.
The military has chosen to focus its intramural research efforts on
areas of specific concern for clinical care of the injured warfighter.
The Navy has focused funding on the clinical aspects of MDRO
infections in war injuries. The two focus areas are:
1. Developing enhanced surveillance and electronic reporting from
Navy laboratories of MDROs to determine the source of these organisms
and minimize their acquisition and spread among patients and staff.
2. Assessing what treatment and management strategies for wound
infections with MDROs are associated with the best outcomes through the
TIDOS (Trauma Infectious Disease Outcome Study).
Dr. Snyder. According to the Navy's statement, coordination of
surveillance, treatment, and research efforts regarding infections in
combat injured has taken years to develop and is only in the last year
coming to fruition. Why did it take so long to achieve this level of
coordination? What ``lessons-learned'' are being implemented to prevent
future delay in similar situations?
Captain Martin and Ms. English. The question is referring to the
development of TIDOS (Trauma Infectious Diseases Outcome Study) that
has been developed at the Uniformed Services University's Infectious
Diseases Clinical Research Program (IDCRP).
With the establishment of the IDCRP in 2006, seed money from the
National Institute of Allergy and Infectious Diseases (NIAID) became
available to initiate TIDOS. Shortly thereafter, IDCRP investigators
were able to demonstrate the critical data that TIDOS would provide
clinicians treating the war injured. Navy Medicine provided funding for
TIDOS in 2009 after the program's value was properly assessed for its
ability to generate evidenced based data to improve how we deliver
care. Adequate funding for TIDOS has been planned through 2011.
The delay between recognizing the problem and initiating a new
program was not a failure to achieve coordination among the Services.
Navy Medicine has a strong working relationship with the Army and Air
Force in the area of infection control. Our efforts to uncover the
Multidrug-Resistant Organism problem were successful and subsequent
efforts to fund clinical research programs have been addressed. Navy
Medicine is currently funding TIDOS and is continuously reviewing
priorities to best respond to emerging needs across the enterprise.
Dr. Snyder. What does the Department of Defense need in order to
have sufficient surveillance capabilities to identify and monitor
multidrug-resistant infections throughout the military healthcare
system? Should the Army's Multidrug-resistant Organism Repository and
Surveillance Network (MRSN) be expanded to become a department-wide
capability? If so, what policy and resources are needed to make this
happen?
Colonel Collier and Colonel Forgione. Expansion of the Army's MSRN
to become a DOD-wide program would provide sufficient surveillance to
identify and monitor these infections. We would work with the Army to
determine what resources would be needed to make this a reality.
Dr. Snyder. Shouldn't MDROs be made reportable medical events in
DOD and service surveillance systems such as the Global Emerging
Infections Surveillance and Response System (GEIS)? Why aren't they?
Colonel Collier and Colonel Forgione. The CDC's National Healthcare
Safety Network and The Joint Commission requires programs to track and
control healthcare-associated infections (from catheters, ventilators,
etc.) and has specific definitions for methicillin-resistant
Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE),
Gram-positive infections. Certain MDROs are not reported due to their
diverse species and broad range of resistance mechanisms; these make
them complex to characterize. While mandatory reporting of Multidrug-
Resistant Organisms (MDROs) across the DOD would be challenging to
establish and maintain, such a program would allow for coordinated
surveillance and response. The first step will be to define which MDROs
will be tracked.
GEIS has supported the clinical laboratories that perform MDRO
screening for our four major military medical centers who receive
combat-wounded U.S. personnel using funds within the currently
established current screening program. A DOD program as suggested in
question one could potentially improve oversight in reporting MDROs
across the DOD. GEIS focuses predominantly on emerging infections
overseas.
Dr. Snyder. What resources and policy are needed to provide
military treatment facilities, particularly those in deployed areas,
adequate standardized laboratory testing capabilities to identify and
characterize MDROs?
Colonel Collier and Colonel Forgione. USAF military medical
treatment facilities (MTF) outside of the deployed areas are adequately
equipped and staffed to perform bacterial identification and antibiotic
sensitivities; emerging Multidrug-Resistant Organisms (MDROs) will be
referred to designated DOD referral labs for advanced testing and
characterization. Larger deployed MTFs should receive supplemental
clinical microbiology assets and equipment. A DOD program policy to
standardize deployed clinical microbiology assets would enhance
surveillance and is essential to standardized analysis, interpretation
and reporting of emerging MDROs.
Dr. Snyder. Since the outbreak of MDRO infections, what additional
infection control and prevention training and education do medical
personnel in deployed military treatment facilities receive? Please
describe the nature and extent of the training, what personnel are
required to take it, and where and how often it is provided. Are there
plans to expand infection control training and education?
Colonel Collier and Colonel Forgione. All USAF medics receive
annual training in infection control (IC) practices and principles as
part of their normal duty assignment. Medics identified to deploy
receive refresher IC training at various training courses (i.e. EMEDS,
CCAT, etc). Individuals identified to deploy as the infection control
officer are required to complete the 5-day Infection Control Course.
Also there is a specific joint course available: ``Infection Control in
the Deployed Setting,'' which deploying IC officers are required to
take. There are no plans to expand these requirements.
Dr. Snyder. Do all deployed military treatment facilities have
trained and qualified infection control officers? If not, why? What
policy or resources are needed to ensure there is not a shortage of
military healthcare personnel trained and experienced in infection
control?
Colonel Collier and Colonel Forgione. Yes, the USAF provides an
officer who has completed the infection control basic course to manage
infection control at Expeditionary Medical Support (EMEDS) facilities.
Dr. Snyder. According to the Army's statement, critical reviews of
infection control practices and challenges in combat theater hospitals
were conducted in 2008 and 2009, which led to improved infection
control efforts. Are there plans to conduct such reviews on a regular
basis in the future? If so, who will conduct these reviews, how often
will they be conducted, and where will the results be reported to? If
not, what policy and resources are needed to establish this process?
Colonel Collier and Colonel Forgione. According to the Army
Infectious Disease (ID) Consultant there are no formal plans for
regular reviews of the infection control practices and challenges in
deployed level III medical treatment facilities (MTF), but plans are
currently underway for a review of the Afghan theater operations in
winter of 2011 by the Army ID Consultant. The USAF has no plans to
conduct a theater review in the coming year. We agree that there is a
need to conduct routine and regular reviews, and support a joint team
concept, using standardized theater infection control practices. The
Air Force Surgeon General is working to have AFIA, our inspection
agency, review infection control practices and outcomes at our
hardened, sustained, MTFs in theater.
Dr. Snyder. What are the principal knowledge gaps and priorities
for military research and development related to MDRO infections?
Colonel Collier and Colonel Forgione. The Joint Program Committee-2
(JPC-2) used Fiscal Year 2010 Defense Health Program e-funds for
approximately 32 Multidrug-Resistant Organisms (MDRO)-focused research
projects in five DOD laboratories, in five civilian university
laboratories, and in four companies in the commercial sector. The
Military Infectious Diseases Research Program (MIDRP)/JPC2 current gaps
for MDROs are:
a. Wound Infection Prevention & Management: Fundamental research
to prevent infections and inform clinical wound management.
b. Antimicrobial Countermeasures: Fundamental research for
discovery of tools to treat MDRO wound infections.
c. Wound Infection Prevention & Management: Applied research for
development of tools to prevent wound infection and inform clinical
wound management.
Dr. Snyder. According to the Navy's statement, coordination of
surveillance, treatment, and research efforts regarding infections in
combat injured has taken years to develop and is only in the last year
coming to fruition. Why did it take so long to achieve this level of
coordination? What ``lessons-learned'' are being implemented to prevent
future delay in similar situations?
Colonel Collier and Colonel Forgione. There was coordination
initially at the level of the infectious diseases specialists from the
time the problem was identified initially on the USNS Comfort at the
start of the Iraqi War in 2003 and the three services mobilized to
tackle this challenging problem. Over the last seven years and despite
the absence of a central coordinating body, the services created a
relatively robust response to the issues despite the challenges
outlined in these questions and our previous testimony. The
infrastructure and research initiatives initiated to date laid the
groundwork upon which we may build a more vigorous and improved DOD
response in 2010 and beyond.
The Air Force Medical Service has not been faced with many patients
with Multidrug-Resistant Organism (MDRO) infections; so, as a service,
the issue has not required significant resources. However, our
significant participation in transporting wounded joint/coalition
patients via the patient movement system (Air Evacuation and through
our theater hospitals (Balad, Bagram)) and the guarantee that we will
be similarly involved in future conflicts mean we must join the joint
effort to address MDROs. To that end, we will continue to place
competent and trained infection control officers at our Military
Treatment Facilities and we support making the Army's Multidrug-
Resistant Organism Repository and Surveillance Network (MRSN) a DOD
program and the use of the Global Emerging Infectious Surveillance and
Response System (GEIS) as a database to track and analyze MDRO
infections.
|
NEWSLETTER
|
|
Join the GlobalSecurity.org mailing list
|
|
|
