[House Hearing, 112 Congress]
[From the U.S. Government Publishing Office]
SACRED OBLIGATION: RESTORING
VETERAN TRUST AND PATIENT SAFETY
=======================================================================
HEARING
before the
COMMITTEE ON VETERANS' AFFAIRS
U.S. HOUSE OF REPRESENTATIVES
ONE HUNDRED TWELFTH CONGRESS
FIRST SESSION
__________
MAY 3, 2011
__________
Serial No. 112-10
__________
Printed for the use of the Committee on Veterans' Affairs
_____
U.S. GOVERNMENT PRINTING OFFICE
67-185 WASHINGTON : 2011
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COMMITTEE ON VETERANS' AFFAIRS
JEFF MILLER, Florida, Chairman
CLIFF STEARNS, Florida BOB FILNER, California, Ranking
DOUG LAMBORN, Colorado CORRINE BROWN, Florida
GUS M. BILIRAKIS, Florida SILVESTRE REYES, Texas
DAVID P. ROE, Tennessee MICHAEL H. MICHAUD, Maine
MARLIN A. STUTZMAN, Indiana LINDA T. SANCHEZ, California
BILL FLORES, Texas BRUCE L. BRALEY, Iowa
BILL JOHNSON, Ohio JERRY McNERNEY, California
JEFF DENHAM, California JOE DONNELLY, Indiana
JON RUNYAN, New Jersey TIMOTHY J. WALZ, Minnesota
DAN BENISHEK, Michigan JOHN BARROW, Georgia
ANN MARIE BUERKLE, New York RUSS CARNAHAN, Missouri
TIM HUELSKAMP, Kansas
Vacancy
Vacancy
Helen W. Tolar, Staff Director and Chief Counsel
Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public
hearing records of the Committee on Veterans' Affairs are also
published in electronic form. The printed hearing record remains the
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of converting between various electronic formats may introduce
unintentional errors or omissions. Such occurrences are inherent in the
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C O N T E N T S
__________
May 3, 2011
Page
Sacred Obligations: Restoring Veteran Trust and Patient Safety... 1
OPENING STATEMENTS
Chairman Jeff Miller............................................. 1
Prepared statement of Chairman Miller........................ 49
Hon. Bob Filner, Ranking Democratic Member....................... 2
Prepared statement of Congressman Filner..................... 50
Hon. John Barrow, prepared statement of.......................... 50
Hon. Michael R. Turner, prepared statement of.................... 51
Hon. Jerry F. Costello, prepared statement of.................... 52
WITNESSES
U.S. Department of Veterans Affairs:
Hon. Robert A. Petzel, M.D., Under Secretary for Health,
Veterans Health Administration............................. 5
Prepared statement of Dr. Petzel......................... 52
John D. Daigh, Jr., M.D., Assistant Inspector General for
Healthcare Inspections, Office of Inspector General........ 7
Prepared Statement of Dr. Daigh.......................... 58
U.S. Government Accountability Office, Randall B. Williamson,
Director, Health Care.......................................... 8
Prepared statement of Mr. Williamson......................... 62
U.S. Department of Health and Human Services:
Michael Bell, M.D., Deputy Director, Division of Healthcare
Quality Promotion, Centers for Disease Control and
Prevention................................................. 39
Prepared statement of Dr. Bell........................... 67
Anthony D. Watson, BS, MS, MBA, Director, Division of
Anesthesiology, General Hospital, Infection Control, and
Dental Devices, Office of Device Evaluation, Center for
Devices and Radiological Health, Food and Drug
Administration............................................. 41
Prepared statement of Mr. Watson......................... 71
MATERIAL SUBMITTED FOR THE RECORD
Post-Hearing Questions and Responses for the Record:
Hon. Bob Filner, Ranking Democratic Member, Committee on
Veterans' Affairs, to Hon. Eric K. Shinseki, Secretary,
U.S. Department of Veterans Affairs, letter dated May 12,
2011, and VA Responses..................................... 76
SACRED OBLIGATION: RESTORING
VETERAN TRUST AND PATIENT SAFETY
----------
TUESDAY, MAY 3, 2011
U.S. House of Representatives,
Committee on Veterans' Affairs,
Washington, DC.
The Committee met, pursuant to notice, at 10:34 a.m., in
Room 334, Cannon House Office Building, Hon. Jeff Miller
[Chairman of the Committee] presiding.
Present: Representatives Miller, Bilirakis, Roe, Stutzman,
Johnson, Runyan, Benishek, Buerkle, Huelskamp, Filner, Reyes,
McNerney, Donnelly, Walz, Barrow, and Carnahan.
Also Present: Representatives Clay, Costello, Luetkemeyer,
Ros-Lehtinen, Shimkus, Turner, and Wilson.
OPENING STATEMENT OF CHAIRMAN MILLER
The Chairman. This meeting will come to order.
Thank you, everybody, for attending today's hearing
entitled, ``Sacred Obligation: Restoring Veteran Trust and
Patient Safety.''
Before we begin, I would like to ask unanimous consent that
all the Members whose names are in front of us be allowed to
sit at the dais. That would be Lacy Clay, Jerry Costello,
Blaine Luetkemeyer, Ileana Ros-Lehtinen, John Shimkus, Mike
Turner, and Frederica Wilson. Without objection, they will be
allowed to participate in today's hearing.
Mr. Filner. Hold it. I do not want Ileana.
The Chairman. Okay. Ileana, you have to leave.
Hearing no objection, thank you all for joining us for this
important hearing.
We, as a Nation, put our trust in the men and women who
serve in our Armed Forces to protect us and our freedom. And in
return, our servicemembers put their trust in us to provide
them with the highest quality healthcare.
However, incident after incident of serious patient safety
violations in U.S. Department of Veterans Affairs (VA) medical
facilities across the Nation in locations such as Dayton, St.
Louis, and Miami resulting in thousands of veterans across the
country receiving notification of their potential risk for
infectious diseases like the human immunodeficiency virus (HIV)
and hepatitis shatters that very trust that veterans should
have in each of us.
After each of these incidents, the VA assured Congress and
the country that it was aggressively addressing patient safety
issues and never again would a veteran's trust be compromised
by lapses in quality care at a VA medical facility and, yet,
each patient safety incident has seemingly led the way for the
next lessons learned and the unacceptable and inexcusable
revelation that the patient safety culture in VA is fractured
and accountability and leadership at the helm are lacking.
The time for talk is over. VA has to confront these issues
head on, deepen the obligation to care for the veterans
affected by these incidents, and make the necessary changes
within the VA healthcare system to prevent any future incidents
that would put veteran patients at risk.
To that end, at this hearing today, we will address in
depth the efficacy of VA's patient safety policies and VA
leadership's ability to provide adequate oversight of its
medical facilities.
Further, we are going to explore the development of
proactive strategies for addressing the issues that underlie
the lapses we have seen in patient safety including the need
for improvements in reprocessing of reusable medical equipment,
systematic ways for VA to limit the activities of suspect
practitioners, and better and more consistent risk management
and notification processes for veteran patients when incidents
do occur.
It is unconscionable that any one of our veterans should
ever be exposed to infectious diseases because of the care they
receive at a VA medical facility.
I want to assure all of you that this Committee will be
tireless in its oversight to ensure that VA lives up to its
creed to provide only the very best and the very safest care
anywhere.
I thank you all for joining us for this ongoing and most
important discussion.
Before I yield to the Ranking Member, I would like to
remind the witnesses that testimony is due no later than 48
hours in advance of a Committee or a Subcommittee hearing. I am
told that the Disability Assistance and Memorial Affairs (DAMA)
Subcommittee did not receive VA testimony until late yesterday
in preparation for today's 8:00 a.m. hearing. To me, that is
inexcusable.
And in addition, I and other Committee Members submitted a
series of questions 7 weeks ago in relation to VA's 2012 budget
request, yet no responses have been received.
I would ask those here representing VA to please convey my
disappointment about this performance and my expectation that
things will improve in the very near future.
And with that, I yield to the Ranking Member, Mr. Filner,
for an opening statement.
[The prepared statement of Chairman Miller appears on p.
49.]
OPENING STATEMENT OF HON. BOB FILNER
Mr. Filner. Thank you, Mr. Chairman, and thank you for
holding this hearing.
Obviously we want to gauge VA's response to several recent
incidents that profoundly affect veterans, as you pointed out,
due to the failure of some to follow policies, procedures, and
protocols that have been put in place to prevent such
occurrences.
We are going to look at what measures have actually been
implemented to ensure that these types of lapses never happen
again.
I have to say, and I think you would certainly agree, Mr.
Chairman, that we have been here before. You have acknowledged
some of the events, but let me just point out the most recent
things.
In December 2008, we were notified of improper reprocessing
of endoscopes, which put thousands of veterans in Murfreesboro
and Mountain Home, Tennessee and Miami, Florida, at possible
risk of hepatitis and HIV.
In February of 2009, another thousand veterans in Augusta,
Georgia, received notifications that they were at risk for
hepatitis and HIV because of improper processing of ear, nose,
and throat endoscopes.
In July 2010, this Committee held a field hearing in St.
Louis, Missouri, which you attended, Mr. Chairman, along with
many of our colleagues here today after we had learned of
lapses in protocol with the cleaning of dental equipment, which
put at risk 1,800 veterans.
The most recent notification, the egregious incidents in
Dayton, Ohio, affected over 500 veterans and involved a whole
host of problems.
The findings beg the questions of proper accountability,
effective oversight, and enforcement of clear policies and
procedures.
Policies and procedures that are sometimes not followed or,
worse, get completely ignored are the issue. I would like to
know where is the strong leadership and effective communication
that is critical when you are entrusted with the care and well-
being of our Nation's veterans.
Let me point to another big concern as a result of these
incidents and that is the absolute need for effective
communication within management ranks and below and also
between management and the Congress.
I am sure that the Secretary of Veterans Affairs agrees
with me on this.
Clearly, VA has had issues with ensuring the sterility of
reusable medical equipment in the past and now other patient
safety issues have come to light as evidenced in the continuing
problem of veterans being vulnerable to infectious diseases due
to the problematic yet prevalent issue of lack of following
sound agency guidelines and policies concerning patient safety.
In addition to what has been looked at over the past 3
years, I am strongly dedicated to the need for ensuring that we
do everything possible so we do not trouble our veterans again.
As we are all well aware, VA has a higher commitment and a
moral compact to provide the utmost level of care possible. It
is this Committee's responsibility to ensure that VA has the
proper resources to fulfill that mission.
Of course, we want to acknowledge and recognize the VA's
excellent healthcare services overall and the dedication of the
vast majority of its staff. The work that you have done so far
to try to mitigate the issues that we will be discussing today
is to be commended.
I would like to pretend that I am looking forward to
today's hearing, but I am not. These are not easy questions.
And, frankly, Mr. Chairman, the issues go beyond just the
incidents themselves.
They go to the communication within the VA. It took a long
time for the right people to know what was going on in each of
these incidents. It goes to the communication with our VA
patients. Sending a letter that basically says you may have HIV
is not the way to deal with these issues.
There is no case management. There is no way for the
veteran to really talk about what is happening, what the
probability of infection is, how to get immediate help, blood
tests and everything else. A phone call going out or a letter
going out to 1,500 people or 1,800 people without further
explanation, without a 24-hour hotline to call?
As far as I know, on some of these incidents, neither the
Secretary, nor this Committee, was ever notified for days or
weeks of the incident. We people at the VA trying to figure out
how to cover it up or try to stifle the whole thing rather than
allowing the most information possible? It seems to me that the
culture of secrecy, the culture of covering up is too prevalent
here.
Mistakes are made in every institution and they will be
made in the VA. But we have to acknowledge and deal with them,
get the information out as quickly as possible and honestly
figure out what happened.
As far as I know, and maybe the panel can correct me, with
all these incidents, we have never been told, Mr. Chairman, of
any personnel changes as a result. The only way to send a
message to an organization that we take these things seriously
is by firing or whatever.
I know you have all kinds of guidelines for this to protect
employee rights and information, but there has to be a way,
even with the issues of the employee rights, to understand
there is accountability here.
I do not know of anybody who has ever been fired. I do not
know of anybody who has ever been let go. I do not know of
anybody who has been specifically reprimanded, punished, or
dealt with when they put the safety of these veterans in
jeopardy.
I think there probably have been, but we have never been
told that. You tell us that personnel changes have been made.
That is not enough. That is not enough. That is not enough to
assure us and then that is not enough to assure the public.
That is not enough to make sure that the good employees at the
VA know that if someone makes a mistake, they are going to be
dealt with.
I think we have to find a new way to handle this, Mr.
Chairman. Not just the procedures and sterilizations, but how
are you going to deal with accountability in a public
institution when employees do have rights, but the public
accountability is paramount?
We have to understand that and deal with it in a new way.
I thank the Chairman.
[The prepared statement of Congressman Filner appears on p.
50.]
The Chairman. I thank the Ranking Member for his opening
statement.
And as usual with this Committee, we ask that all Members
hold their statements so that we can get to the witnesses, but
each Member will be allowed to enter their statement into the
record without objection for printing purposes.
And I would like to welcome the first panel to the table
this morning, Dr. Robert Petzel, who is VA's Under Secretary
for Health; Dr. John Daigh, Assistant Inspector General for
Healthcare Inspections at the VA Office of Inspector General
(OIG); and Mr. Randall Williamson, Director of the Healthcare
team at the U.S. Government Accountability Office (GAO).
Gentlemen, thank you very much for joining us here this
morning.
And, Dr. Petzel, you may proceed.
STATEMENTS OF HON. ROBERT A. PETZEL, M.D., UNDER SECRETARY FOR
HEALTH, VETERANS HEALTH ADMINISTRATION, U.S. DEPARTMENT OF
VETERANS AFFAIRS; JOHN D. DAIGH, JR., M.D., ASSISTANT INSPECTOR
GENERAL FOR HEALTHCARE INSPECTIONS, OFFICE OF INSPECTOR
GENERAL, U.S. DEPARTMENT OF VETERANS AFFAIRS; AND RANDALL B.
WILLIAMSON, DIRECTOR, HEALTH CARE, U.S. GOVERNMENT
ACCOUNTABILITY OFFICE
STATEMENT OF HON. ROBERT A. PETZEL, M.D.
Dr. Petzel. Chairman Miller, Ranking Member Filner, and
other Members of the Committee, thank you for the opportunity
to discuss the Department of Veterans Affairs' patient safety
policies and strategies to build trust and ensure the safe and
compassionate care of this Nation's veterans.
I am accompanied today in the first row by Dr. Robert
Jesse, the Principal Deputy Under Secretary for Health; Mr.
William Schoenhard, Deputy Under Secretary for Health,
Operations, and Management; Dr. George Arana, Acting Assistant
Deputy Under Secretary for Health for Clinical Operations; and
Dr. Andrea Buck, Acting Chief Medical Officer.
I have submitted the written testimony and ask that it be
entered into the record.
First and foremost, I want to apologize on behalf of the
Department of Veterans Affairs to those veterans who have been
affected by these lapses in patient safety practices at any of
our facilities.
The primary commitment of every VA employee is the well-
being of our veteran patients. When a lapse in patient safety
practices occurs, we believe that we must be open and
transparent with regard to our mistakes and any necessary
actions that need to be taken.
We carefully consider the effects of any disclosure, but
our practice is to provide more information to our veterans in
an abundance of caution even if the risk is very, very low.
We believe we provide excellent healthcare overall. Despite
caring for patients that are on average sicker, older, less
affluent than the general population, VA's performance exceeds
the best U.S. healthcare systems.
We are very open with our information. We report more
quality data about our programs online than any other
healthcare system in this country.
Our written statement provides an overview of our quality
and safety programs, our practices for standardization, of
reprocessing, and our credentialing and privileging practices
and finally our risk management and notification for patients'
procedures.
Right now I would like to make three points. First, we are
focused on continuous improvement to all of our programs. We
publish an annual report on each facility's quality and safety
performance online and we are providing data to the U.S.
Department of Health and Human Services' (HHS) Web site so that
veterans can compare the care that is delivered in their
facilities with the care that is delivered in the private
practice.
We conduct detailed investigations of not only adverse
events but of close calls because even if a veteran was not
harmed in a particular situation, we never want to put that
patient at risk for that particular problem again.
We subject our facilities to dozens, dozens of reviews
annually. Our facilities are subjected to inspections by the
Joint Commission, the Commission on Accreditation of
Rehabilitation Facilities, the Inspector General, the Medical
Inspector, the GAO, and a number of other external and internal
quality and safety reviews.
We not only appreciate this oversight, we welcome it. It is
through these internal and external assessments that we can
detect problems, identify best practices, and change the way we
do our business. No matter what the outcomes, these reviews do
improve the care that we deliver to our veteran patients.
Secondly, we have made significant progress in
standardizing, sterilizing, and processing reusable medical
equipment across the country. Several of the incidents that are
being discussed today were the result of improper reprocessing
of reusable medical equipment. This is one area we are looking
at for even further enhancements.
We standardized the purchase of reusable medical equipment
and we are using leases to ensure that the latest and best
equipment is available so that we go from 40 different brands
of colonoscope at a medical center to less than 10 brands of
colonoscope at that medical center to simplify the process of
re-sterilizing that equipment.
We have created an Office of Clinical Consultation and
Compliance that is implementing better tracking and
documentation control measures over our reusable medical
equipment.
And we are subjecting our programs to the requirements of a
program called ISO-9001. This is an industrialized,
standardized process for quality control. And we are
collaborating with the leaders in this field to improve our
training, accountability, and practices in our Supply,
Processing and Distributions (SPDs).
We are looking to work with the private sector to automate
our practices to reduce the potential for human error, and four
levels of review of our SPD programs are conducted. The
facility does reviews. The network or Veterans Integrated
Services Networks (VISN) does reviews. There are national
reviews and we have external entities that review our SPD
processes on an annual basis.
Finally, we have a careful assessment process to determine
when we should disclose an event to veterans. We convene a
fact-finding board to discuss the event and a clinical review
board to determine if disclosure should occur. This rigorous
process has been recognized by The New England Journal of
Medicine as a best practice and a model for the rest of the
country.
These boards are comprised of subject matter experts from a
range of disciplines to determine who should be notified and
how we best should do that.
In conclusion, our mission is to serve the Nation's
veterans by providing them the best healthcare anywhere. We
take this responsibility very seriously. And we appreciate the
opportunity to discuss these programs that we have in place to
deliver on this promise.
Thank you for inviting us to testify here, and my
colleagues and I look forward to your questions.
[The prepared statement of Dr. Petzel appears on p. 52.]
The Chairman. Thank you, Dr. Petzel.
Dr. Daigh.
STATEMENT OF JOHN D. DAIGH, JR., M.D.
Dr. Daigh. Good morning, Mr. Chairman, Ranking Member,
Members of the Committee. It is a privilege to discuss the
published work of the Office of Inspector General as it relates
to the patient safety issues under discussion today.
I believe that based on the body of work that we have done
over the last several years, the VA does, in fact, provide
high-quality medical care to veterans. Nevertheless we are here
today to discuss failures by VA to provide properly
reprocessed, reusable medical equipment at the point of care,
delivery thus resulting in the notification to thousands of
veterans that they are at risk of becoming infected with blood-
borne pathogens.
My conclusion is that these instances result from two
problems. One is the inability of selected facilities to follow
established guidelines and directives with a zero defects
culture, that is to do their job correctly every day and every
time.
The second problem that I see from these issues is
instances of leadership failure where compromises were made to
acceptable infection control standards that placed veterans at
risk.
I recommend the VA consider changes to their current
policies and procedures and offer a few suggestions.
One, the hospital leaders must have unfettered input from
their employees, particularly those employees who I would call
technicians. They run the lab. They operate the ultrasound
machines. They provide and support a great deal of the care
that is provided throughout the hospital.
The nurses have a direct line of flow of data to the
hospital leadership. The providers have a direct line of flow
of unfettered data. I think it is imperative that the hospital
director reach out and speak directly with the technicians to
ensure that the data is congruent, that they are hearing about
what is going on in their hospital.
The second, I think VA should consider position rotations
or forced vacations as a management tool in selected
circumstances. Where senior hospital leadership is viewed as
unresponsive to employee concerns, the quality of medical care
may be placed at risk.
The third, I believe VA has, in fact, an excellent adverse
event disclosure policy that is, in fact, the national
standard. However, I think in light of recent events, I think
it is time to have a broader discussion of the risk management
policies and the communication policies that entail this
adverse event disclosure issue.
And, fourth, I think senior hospital officials must very
carefully examine those instances in which a provider has
privileges at the hospital that are less than expected for that
provider's position or recent history. A limitation of
procedures alone may not provide the margin of safety
anticipated by the credentialing and privileging Committees.
I thank you for this opportunity to testify today and will
do my best to answer your questions.
[The prepared statement of Dr. Daigh appears on p. 58.]
The Chairman. Thank you, Dr. Daigh.
Mr. Williamson.
STATEMENT OF RANDALL B. WILLIAMSON
Mr. Williamson. Good morning, Members of the Committee.
The Chairman. You might check your microphone really
quickly.
Mr. Williamson. I am sorry. I am pleased to be here today
to discuss our report issued this morning that addresses VA
policies and oversight governing the cleaning and disinfecting
of reusable medical equipment, which I will refer to as RME.
Lapses by some medical centers in cleaning such equipment,
which includes dental instruments, endoscopes, and surgical
instruments have recently come to light. Such lapses have put
thousands of veterans receiving care at these medical centers
at risk to exposure of HIV, hepatitis, and other infectious
diseases.
In my testimony today, I will describe our findings in two
areas. First, I will address deficiencies in VA policy
requirements for training its medical center staff to properly
clean and disinfect RME. And, second, I will discuss needed
improvements in VA's oversight of medical center staff to
ensure that they comply with these policy requirements.
Regarding the first area, we visited a cross-section of six
VA medical centers across the Nation and found some disturbing
deficiencies with respect to VA requirements for devicespecific
training for cleaning and disinfecting RME. These deficiencies
indicate systemic problems that need to be corrected at the
national level.
Two issues came to light here. For one, almost all medical
center officials we talked with said that VA guidance was
unclear as to which types of RME required devicespecific
training to ensure proper cleaning techniques. This resulted in
devicespecific training not being developed at all six medical
centers we visited for some critical RME such as surgical
instruments.
At one medical center, for example, officials told us they
had developed devicespecific training for non-critical RME such
as wheelchairs, but they have not completed training for more
critical RME.
Another training issue involved conflicting guidance that
was provided to medical care staff about developing training on
how to clean RME.
Officials in three medical centers, for example, told us
that certain headquarters' or VISN officials had told them to
develop devicespecific training for RME that closely matched
manufacturer guidelines.
Later other headquarters' and VISN officials told them to
write reprocessing instructions in a way that could be readily
understandable rather than strictly following the manufacturer
guidelines.
This led to multiple rewrites of training instructions by
medical center staff, which are both time consuming and a waste
of resources and could lead to preparation of insufficient
training instructions for cleaning RME at some medical centers.
Headquarters' officials told us they are aware of these
deficiencies and have begun efforts to remedy them. For
example, VA officials said they have recently gained access to
a commercial database of standardized devicespecific training
developed by manufacturers for over a thousand pieces of RME
and have made this database available to medical centers.
For RME where manufacturers have not developed
devicespecific training, VA officials said they plan to develop
this training and provide standardized instructions to its
medical centers. But at the time of our review, VA had not yet
done this and had no firm plans or time table for completing
this task.
With respect to RME oversight, VA has recently initiated
efforts to improve its oversight of medical centers with
respect to complying with RME reprocessing requirements. These
efforts include increasing the frequency of unannounced site
inspections to medical centers, requiring VISNs to use
standardized assessment tools, and requiring the results of RME
inspections at medical centers to be reported to headquarters.
Despite these changes, improvements in VA oversight are
still needed. Most notably, while VA now requires that all RME
inspection results from its medical centers and VISNs be
submitted to headquarters, VA does not systematically analyze
this information across its medical centers. Such analysis are
important to assess the extent and risk of noncompliance with
RME reprocessing requirements across its medical centers and to
determine whether identified noncompliance cases have been
addressed.
VA headquarters' officials said they planned to address
oversight weaknesses we identified including analyzing
information to identify noncompliance with RME requirements
across its medical centers. However, completing these changes
is contingent on implementation of the VA organizational
realignment in this area which was still ongoing earlier this
month.
In summary, while VA has taken some steps to strengthen
both its methods for reprocessing RME and its oversight over
this process, much remains to be done. Until VA's improvement
efforts in this area are completed, veterans may continue to be
at risk to RME related infectious diseases.
Thank you, Mr. Chairman.
[The prepared statement of Mr. Williamson appears on p.
62.]
The Chairman. Thank you for your testimony.
And we will start a round of questioning. As our usual
course, Committee Members will go first and then we will have a
round for the non-Committee Members as well.
But on my time, and I will adhere to the 5-minute clock as
well, Dr. Petzel, would you like to respond to Mr. Williamson
and his presentation regarding their report?
Dr. Petzel. Thank you, Mr. Chairman. I would.
We appreciate both the GAO and the OIG inspecting our
reusable medical equipment processes as well as the other
things they do because, as I said in my oral testimony earlier,
we do learn. And we have concurred in the recommendations that
the GAO specifically made.
I want to point out a couple of things. Number one is that
we do now have a standardized database that covers the
majority, the vast majority, in fact, of the processes, the
standard operating procedures for processing reusable medical
equipment. And that means we do have across the country
standardized operating procedures for cleaning. In those areas
where the commercial database does not cover, we have developed
those ourselves.
And contrary to what Mr. Williamson said, we do not
tolerate people writing their own procedures. We have a
standard for cleaning whatever that piece of equipment is
across the country. It may not have been completely in place at
the time they did their inspection, but it is now and it is our
practice around the country.
The Chairman [continuing]. If I could----
Dr. Petzel. Two----
The Chairman. If I could, on number one, you said in place
for most of, but the implication is not all?
Dr. Petzel. Well, what I said was that the commercial
database that we bought does not cover absolutely everything.
And we have developed or we have in place processes for those
things not covered, which are relatively few, not covered by
this database that we----
The Chairman. Give me an example of what would not be
covered.
Dr. Petzel. There might be some small surgical instruments.
The Chairman. Does that mean you wrote them or----
Dr. Petzel. That means the manufacturer has them, they are
not in the database, and we use the manufacturer's information.
The Chairman. So you do have everything covered, but some
is not in that database that you purchased?
Dr. Petzel. That is correct.
The Chairman. Okay. And number two?
Dr. Petzel. And number two is that the training that was
described in the GAO report is, in fact, in place and has been
done in the vast majority of our places. We have begun a
process of certification for all of our technicians. We have
developed an institute or an academy of SPD where we bring
people specifically down to go through the training process.
We require that every SPD document the fact that their
people, their technicians have been trained on the instruments
that they are responsible for reprocessing.
And I believe that the last look that the OIG made at how
well we have done with that training indicated that we were
close to but not yet perfect in terms of the number of people
that were trained. In other words, there were some instances
where they found no evidence of the training, not that the
training had not been done, but no evidence.
So that is number two is that we have indeed set up a
process for ensuring that our people are properly trained.
And then the last item that I wanted to discuss in the GAO
report is the Central Office oversight, again a point that we
agreed with, that we need to have in place the mechanisms that
allow us to be assured and are able to assure our patients and
you all that we are periodically looking at the SPD and how it
is functioning and assuring ourselves, you all, and the public
that indeed those things that we say need to be done are being
done, the training, the following standard operating
procedures, et cetera.
As I mentioned in my oral testimony, there are four levels
of oversight that occur in the SPD. There is a local
requirement for oversight. We changed the reporting structure
in SPD to a clinical person, the nurse executive in the
executive quadrant.
We require that the networks periodically, three times a
year, inspect the SPD using a standardized assessment tool
which I think most people would agree is probably a benchmark
standard within the industry. Then we from Central Office do
our regular periodic inspections of the SPD for both infection
control processes and reprocessing.
And then finally, as mentioned, there are a number of
outside organizations that periodically look. The OIG does
their combined assessment programs that include looking at the
SPD and that is done every 3 years. The Joint Commission looks
at SPD. The medical inspector periodically looks at SPD. We
have an internal Systematic Ongoing Assessment and Review
Strategy (SOARS) process that looks at SPD.
So there are at least nine levels of oversight of SPD right
now.
The Chairman. I think in your opening statement you talked
about four levels of oversight.
I think the GAO talked about inability to follow guidelines
and need for unfettered input from employees. They found
disturbing deficiency and systematic problems. You said you
have begun a process of certification.
If you do all of those things and your managers do not
follow the rules, what do you do?
Dr. Petzel. We would discipline them.
The Chairman. Have you?
Dr. Petzel. We have.
The Chairman. Have you fired anybody?
Dr. Petzel. We have proposed removal in a number of
instances and almost invariably the individual has resigned or
retired as a result of the proposed removal.
The Chairman. Can you give us a number of individuals that
you proposed removal of?
Dr. Petzel. There are, I believe, three physician or dental
level people that that has occurred with, several chiefs of SPD
where that has happened. We have also reprimanded individuals,
suspensions, and letters of counseling.
The Chairman. One of the dentists was in his eighties; is
that correct?
Dr. Petzel. Close, yes.
The Chairman. Mr. Filner.
Mr. Filner. Dr. Petzel, you are here as a representative of
the VA. We have gone through this before, sir. It seems to me
your job here should have been, and we have Members of Congress
from all the districts that have been affected, was to begin to
restore some trust and confidence in your institution.
I hate to take a poll. If I did, if I asked how many people
now have confidence that everything is fine in your VA
hospital, I doubt if anybody would raise their hand. You said
everything was fine. It is not true, simply not true.
You talk about transparent procedures and New England
Journals, best practices, and, yet, every time something
happens, we have a disaster.
We do not have a way of communicating. We do not have a way
of dealing with the personal concerns. We do not have any
knowledge that anybody has been reprimanded.
Now you tell us that you have reprimanded three employees.
We have been going over this for years and now hear these
results. Still, you have never told this Committee those
figures before, as far as I know.
But, Dr. Petzel, we have gone through this before. We have
raised concerns in our opening statement. You read your opening
statement as if we never said anything. So you never addressed
issues of accountability. You never addressed issues of
communication, whether within your agency, the veterans or with
this Committee.
I have gone through the timelines with almost every one of
these Members here and their hospitals. You say panels get
together to decide should we disclose, what should we disclose,
who should we--it looks to many of us like they get together to
decide what do we keep secret from our--you keep shaking your
head no.
Why did it take 8 weeks at St. Louis where Mr. Carnahan
will raise the issues for that panel to decide to tell people
that almost 2,000 people were infected, possibly infected with
HIV? It took 2 months before you guys decided that.
The Secretary was not notified, as far as I know, in his
words to me during that whole period of time. It sounds like
you are sitting there deciding ``what is the minimal amount of
information that we can give out so people do not get upset
with us'' rather than the maximum.
That first day, I would have had the Secretary have a press
conference and explain the possibility of X hundred or X
thousand of people being exposed. We are going to get to you
right away. We want to make sure you know this is happening and
put pressure on yourselves to become public because, otherwise,
there is no pressure for you to do anything.
We did not know anything. The Secretary did not know
anything. I do not know if you knew anything because these guys
are basically meeting to determine how to keep this secret for
as long as possible and maybe we do not have to disclose at all
because your question was, should we disclose, not how to do
it.
As I said, your whole disclosure process is as if everybody
knows all your acronyms and your initials for everything and
all these SPDs and RMEs as if the patients know what is going
on.
They get a letter. I have seen these letters. It says
basically, it is not this bad, but you may have HIV. They get a
letter. It may have even gone to a wrong address.
For 1,500 people, as I said to you earlier at a hearing,
you should have had 1,500 of your 250,000 employees, assigned
to somebody to call them, go visit them, find out when they can
come back, when they can get their blood test. Treat them as if
they may have HIV, and they are scared to death that they are
going to die. Instead, you send them a letter.
There is no one necessarily there to answer a phone call
when they call back because you do not have people working this
like case managers. One person to every five people is not
enough, I think you should do one on one.
What you described as this open, transparent process does
not come through. And every one of these people has
constituents which I bet can confirm what I just said. Even if
it is only the perception and not reality, that is just as bad.
You were not very personal in your notification. You were not
very clear about what it is that they might have. You did not
followup in a way that was very quick. And then, we do not know
anything about accountability. We know nothing from basically
what you said today.
You have to develop a new system. We just killed Osama Bin
Laden and they notified eight Members of Congress and the
Committees were notified and, they kept that confidential.
Maybe you should notify the Chair and Ranking Member of the
Veterans Committees about what you are doing in terms of your
personnel.
But there is no sense that you have done anything. Nobody
in Dayton, nobody in St. Louis, nobody in Miami, nobody in
Tennessee knows anything about that accountability. And I doubt
anybody in the system knows about it, so they do not think
there is any accountability.
So I wish you would address these issues. We have gone over
them for several years. You and I have gone over these exact
issues several times at hearings and then you do the exact same
thing. You give me a prepared statement that everything is
fine. You move the discussion into these arcane things about
SPDs and RMEs and you neglect the basic issues of communication
and accountability that are at the heart of the confidence that
our people have in your system.
You may comment in any way you want.
Dr. Petzel. Thank you, Mr. Filner.
What I want to do is first talk about our notification
process. The process by which we determine who ought to be
notified or who might be at risk, as I said before, is an
industry standard. I will stand by that process. Under any
circumstance, it takes some time, but it is transparent and it
is weighted heavily in the favor of----
Mr. Filner. Nobody knew about St. Louis for 8 weeks, 8
weeks.
Dr. Petzel. Sir----
Mr. Filner. If that is the industry standard, you should
not--we should not be following the industry standard.
Dr. Petzel. Sir, I am not talking about the communication.
I am talking about the process that we go through. It is very
thorough and it is weighted on the side of being abundantly
cautious to be sure that we take into account every possible
risk.
The process by which we disclose to patients involves
letters, phone calls, and case managers, particularly in the
instance of St. Louis. Every single individual that was
affected was called. They were offered a case manager. There
was a case manager involved. In fact, in some instances, the
leadership of the medical center.
I will admit that we have learned iteratively since the
first episode----
Mr. Filner. But, sir, that conflicts exactly with what you
said to me at St. Louis. The Chairman was there. Mr. Carnahan
was there and Mr. Clay was there. Mr. Shimkus was there. You
never mentioned the word case manager. You never mentioned that
they were called.
Is that right?
Dr. Petzel. No.
Mr. Filner. I mean, we went through this discussion with
you. This is the first word I ever heard of a case manager
because I said to you, why don't you have case managers. You
said, yes, we will look at that.
We are both going to review your testimony in St. Louis
because it is contrary to what you just said now.
Dr. Petzel. Again, we have learned iteratively about the
process of notifying people and early in this with the first
episodes that we had in Miami and Augusta, I do not think we
did a good job to be very candid with you.
But with the next several episodes, I think we have done a
better job of sending letters, calling people, and giving a
hotline number to call and making people available to them to
answer their questions about what happened.
And, again, after reviewing what is done across the Nation,
I would stand by the process that we have right now as being an
excellent way of notifying people when there has been potential
exposure.
Mr. Filner. I hope all of our non-Committee Members who are
here will speak to those issues from the way you saw them or
your constituents told you. I hope so.
Thank you.
The Chairman. Dr. Roe.
Mr. Roe. Thank you, Mr. Chairman.
And not too many questions, but having served as chief of
staff of a hospital and a hospital board chairman, you are
responsible and you feel that responsibility for the care that
is given by your institution.
And I have noticed a couple of things here that bother me a
little bit for the last couple of years is that when you talk
about the instruments, SPDs where the instruments are cleaned,
it really gets down to one or two or three people in any
hospital that are doing this. It is not a whole big system. It
is people doing it.
And those people probably think they are doing the job
right, but if they have not been trained to do it properly,
they are going to continue to do it wrong.
I can assure you that in the private sector, had this
occurred like this just did and a medical/legal case had
resulted out of it, you just get your pencil out and start
writing commas and zeros. I can tell you can get the checkbook
out because this private system would not tolerate this.
I can tell you right now when you have this no matter if it
is the SPD that does it, I know who is captain of the ship and
I know who is going to be responsible for that error that has
occurred. And there have been numerous errors here.
One of the things that we have to sell in medicine is
trust. Our patients need to trust us. They need to trust the VA
that that is where the quality of care and transparency. Mr.
Filner is absolutely 100 percent correct. I can assure you that
when I had a problem go wrong in my shop when I practiced
medicine, not the clerk that answered the phone made the call
to the patient, I made the call to the patient. I called them
up. I explained to them. I had them come in and tell them what
was going on.
And I can tell you in a large institution with multiple
people, I would have had the highest level people contacting
someone when they think they have HIV or a potential life-
threatening condition.
Now, because these instruments were cleaned in a certain
way does not mean that it gave the patient that. We do not know
what the incident was to start with. I mean, we do not know, in
these patients, we do not know, but they do not know either.
So I think Mr. Filner is absolutely dead on right. And it
is not the crime. It is the cover-up or even perceived cover-
up. I mean, nobody is trying to hide. I do not think you are
trying to hide anything. I know that. In my gut, I know that.
But you have a huge system and you have to put systems in
place where people are trained and to where their training is
evaluated so that those things do not occur. And I do not have
the feeling yet that that has been done. Maybe it has been.
Maybe you can make me feel better. But from what I hear from
Mr. Williamson, he did not see it that way.
Comment.
Dr. Petzel. Dr. Roe, I believe the training is in place. I
do believe the policies are in place to do this.
The Chairman. Doctor, could you hit your microphone? Thank
you, sir.
Dr. Petzel. I do believe it is up to our oversight
processes to assure us, assure you, and assure the veteran
population that, in fact, those things are being done.
We have learned a lot from these episodes going back to
2008. And I think we are a better system because of it and I
think we do have the best, if you will, in terms of
reprocessing an SPD that is available in this country right
now.
Mr. Roe. One of the things that we had in our medical/legal
training in Tennessee was we had the airline people come to us
and go over their procedures, which are absolutely textbook.
Now, when you take a plane off and you will almost find out
every time it is a pilot error.
And what you will find out here without oversight, it will
be an individual person making an error as in the dentist
example you gave. But that was not dealt with. That is the
other problem is that when you see that problem, it has to be
dealt with.
And I have done that. It is not fun to go in to talk to
somebody who is a 30-year member of your shop and say you are
not performing at the level we accept. That is not easy. I have
done that. That is very hard to do.
And I do not get the feeling that that was handled very
well when this problem apparently was identified for years and
never dealt with. So again, you have to have those procedures
in place and then you have to follow those procedures and they
have to be lock step. If you do not, you will have these
errors.
And I think the other thing you are doing is it is much
simpler when you have the same equipment all the time. And you
have multiple kinds of equipment and doctors are terrible about
that. We have our little toy we like to play with. But we can
play with any toy if we learn how to do it. The fewer toys you
have, the easier it is to not make those errors.
Dr. Petzel. I absolutely agree with that last comment. We
are frantically standardizing our reusable medical equipment.
We just signed two lease contracts for colonoscopes and
endoscopes. There are only two manufacturers. The fact that
they are leases means that we will be able to turn over the
latest model.
What has happened in the past is that they will buy some
new endoscopes, but they will keep the old endoscopes as well.
So you have maybe 7 or 8 years worth of models all of which
have different instructions about how to clean, et cetera. This
is going to allow us to have only the most up-to-date models
and many, many fewer instruments that we have to learn the
procedures for cleaning. I think that is an excellent point.
Mr. Roe. Thank you.
I yield back, Mr. Chairman.
The Chairman. Mr. Walz.
Mr. Walz. Thank you, Mr. Chairman.
And thanks to all of our witnesses for being here.
And I, like Dr. Roe, was at that hearing a few years ago on
the endoscopes. And I do appreciate some folks brought several
into my office and taught me how to do it because my goal was
to see exactly what the procedure here was.
And I want to be very clear. Everybody in this room, the
care of our veterans is the number one concern. And I
absolutely have no doubt of that. It is a zero sum game. One
injured veteran is one too many.
But I want to bring up, Mr. Williamson, to you, and I was
looking at a recent New England Journal of Medicine report, let
us be very clear here that this is not a problem associated
with only the VA.
How do the private hospitals report this? When I hear
numbers of 98,000 deaths, 1.5 million injuries per year in the
private sector and I was. Dr. Roe, I am going to have to get
with you on that. I almost thought I heard you saying that the
threat of the legal action kept people doing better things, but
I will clarify that with you.
But the idea on this is how much, how prevalent, can you
make any comparison to--is this systemic with the leadership in
the VA or how things are done or is this is a broader problem,
which I would argue representing places like the Mayo Clinic
and VA facilities that it is systemic across the board in
medical delivery.
Mr. Williamson. Well, Mr. Walz, you may be right about the
breadth of it, but we basically concentrated on VA. We did not
examine any private-sector data in this regard.
Mr. Walz. So we do not have the ability then to--we were
using best practices there, but the argument I would make is
are we absolutely certain, and do not get me wrong, one is too
many, but are we absolutely certain the practices being applied
in the VA are worse than the private sector even though our
goal is to have the best care?
Dr. Petzel, can you----
Dr. Petzel. Congressman Walz, thank you. I can make just a
couple of comments.
The New England Journal of Medicine article that I was
describing before that cites us as being the best, the best
example of how to assess risk and how to contact patients also
cites 18 other examples of potential exposure across the
country ranging from 40,000 people in one instance to just a
couple in another. It is a prevalent problem across the
country.
I believe, and we have had some confirmation of this from
other people, that we are doing an excellent job of trying to
achieve the Six Sigma performance in our SPD.
The ISO-9001 that I spoke about before is an
industrialization of the whole process. Very few other people
are doing that in their SPDs. The inspections that we go
through are not done in many other parts of the country.
So I think that, I mean, I do not want to compare us to the
private sector completely, but I think we are doing a good job,
not a perfect job. As has been pointed out by a number of
people, we have to do better and we will continuously improve
this. But I think we are on the right path.
Mr. Walz. So the Six Sigma process is translating. Are we
focusing on the one/one-thousandths in here because I said even
if that is what it is, we are going to focus on that, the care
for our veterans? Is that what is happening?
Dr. Petzel. That is the kind of performance that we are
trying to emulate, correct.
Mr. Walz. That is right.
Mr. Williamson. I would add, too, though, that we looked at
VA policies and what VA requires and the standard of excellence
that they require of their people you can compare VA to the
private sector, and I really do not know what is going on
there, but you really need to compare it against the standard
of excellence that VA set for itself. And it was not doing the
job.
Mr. Walz. Yeah. Good point.
And I think that, Dr. Petzel, you agree with that, too,
because I think the question and the frustration coming from my
colleagues is that whether it be communication or very
disturbing to me with the dental incident of someone actually
passing on information of poor practices, less than best
practices and, yet, the appearance was not anything done about
it.
I think that frustration that the Chairman experienced
asking, well, did you remove these people because there are
barriers to doing that? I want to be very clear on that. Are
our managers given the freedom to be able to make changes in
due process with basic principles, but are they able to do
that?
Dr. Petzel. They are. The Civil Service rules are complex
and complicated, but if you follow the right processes and
procedures, it is possible to do that.
I want to just make a comment about Dayton and the dental
that has come up a couple of different times. And I want to be
perfectly clear. That was a failure of leadership. That was a
failure of leadership within the dental clinic.
The people that worked with this individual knew that this
was not appropriate. The technicians knew that it was not
appropriate. The chief of dentistry knew that that was not
appropriate. And for a long period of time, none of these
people took the kind of action that they needed to take. And
unquestionably that is a failure of leadership.
Mr. Walz. I appreciate that. I appreciate all your work.
And as I said, I am, of course, your biggest supporter, but I
will also be your harshest critic until we get this down to the
best anywhere. So I appreciate that.
And I yield back.
The Chairman. Mr. Johnson.
Mr. Johnson. Thank you, Mr. Chairman.
You know, as a former Air Force officer myself and as a
veteran, I am very concerned about what I am hearing here. You
mentioned several things. I heard earlier in your testimony or
in response to one of the questions, you indicated that none of
the technicians were permitted to write their own instructions,
that there are standards to follow.
I think you also expressed confidence in your oversight
processes to catch these things. And just now to my colleague's
questions, you talked about how everyone in Dayton knew that
this was going on and that it was a failure of leadership.
Which leadership are you referring to? Where is the
failure?
Dr. Petzel. I did not refer to everyone in Dayton knew this
was going on. I referred to everybody in the dental clinic----
Mr. Johnson. Right. Okay.
Dr. Petzel [continuing]. Knew this was going on. And I
think the primary failure there was the leadership in the
dental clinic.
Mr. Johnson. Okay. Well, let me refer you to a GAO report
that came out today. The title of it says ``Weaknesses in
Policies and Oversight Governing Medical Supplies and Equipment
Pose Risks to Veterans Safety.'' Down in the oversight over
reprocessing requirements, let me give you this quote.
It says although VA headquarters receives information from
VISNs on any noncompliance they identify as well as VAMC's
corrective action plans to address this noncompliance, VA
headquarters does not analyze this information to inform its
oversight.
Dr. Petzel, how can you express such confidence in an
oversight process that does not even properly identify and
analyze the information coming up through the system? And I
submit to you that the failure in leadership is not just at the
dental clinic. It is right here in Washington.
Dr. Petzel. Well, first of all, Congressman, the issue in
the dental clinic in Dayton was not one of reprocessing. This
was one of infection control and the practices of a particular
individual.
Mr. Johnson. But aren't those covered under your oversight
processes?
Dr. Petzel. In a different manner than the reusable medical
equipment, but, yes, there are some oversight processes
associated with that.
Mr. Johnson. Well, let me take just a second. Why GAO did
this study, Department of Veterans Affairs' VA clinicians used
expendable medical supplies, disposable items that are
generally used one time, and reusable medical equipment, which
is designed to be reused for multiple patients.
And this GAO study looked at all of that. So they are
looking at not only the reusables, but they are looking at the
exposables and they identified serious weaknesses in the
analysis and identification of the information that comes to VA
headquarters.
How do you respond to that?
Dr. Petzel. We agreed with them and we agree that that was
an appropriate thing to be doing and are now instituting a
process to do that, to systematically look at the information
we get to look for trends, to look for possible themes that run
through those things. And we are now doing that. We agreed with
them that that was a wise thing to be doing.
Mr. Johnson. I guess I refer back to my colleague, Mr.
Filner. You know, we have been talking about these things for a
very, very long time. Why are we just now starting?
You know, I met with a group last week, whether it is in
the oversight of expendables and reusables or whether it is in
oversight of the claims process, I met with a focus group that
has identified glaucoma cases where patients, veterans have
been identified with glaucoma and, yet, their referral for
treatment took so long to get through the system that by the
time it actually came up that they got treatment, it was too
late and their condition was irreversible.
And in the oversight and investigation arm of this
Committee, I can assure you we are going to be looking into
those as well.
So how can we say that your oversight processes are even
close to being adequate and why are we still talking about
these things rather than doing something about them to protect
the health and welfare of our veterans?
Dr. Petzel. Well, Congressman, we have not just started
doing this. We have been doing this for----
Mr. Johnson. But that is what you just said. That is what
you just said.
Dr. Petzel. I said that particular----
Mr. Johnson. You said we are now doing it.
Dr. Petzel [continuing]. I said that particular aspect of
the oversight is something that we are beginning to do early in
2010.
Mr. Johnson. My----
Dr. Petzel. But the process of looking at RME, of improving
RME, of oversight, of training, et cetera, these began quite a
long time ago. And they have been continuously improved since
our first instance of exposure possibly in 2008.
Mr. Johnson [continuing]. My time is up, Dr. Petzel, and I
am going to yield back, but I want to just summarize with this.
And I agree with my colleague, Mr. Filner.
If there is anything that it appears that the VA is expert
in, it is talking around these problems and kicking the ball
down the stream in a number of areas. We do not seem to get
specific solutions to specific problems that greatly affect the
health and welfare of our veterans. And that is a very
concerning scenario to me.
Mr. Chairman, I yield back.
The Chairman. Mr. Reyes.
Mr. Reyes. Thank you, Mr. Chairman.
And thank you, gentlemen, for being here this morning.
I wanted to ask if there was a way to compare what is
occurring at the VA in terms of these particular issues,
failings with whatever the standard might be on the civilian
side or perhaps even in other systems similar to the VA even if
we are considering other countries.
I understand that my colleague, Mr. Walz, asked something
similar, but I have to leave for a little bit and so I
apologize for doing that. But I wanted to know if there is a
basis for comparison about what is occurring at the VA.
Dr. Petzel. Well, Congressman Reyes, there is and there is
not. First of all, whatever, however we compare to the civilian
sector, the fact that this happens to even one of our patients
is not a good thing and needs to be changed and needs to be
improved.
So on the one hand, it is almost irrelevant how we compare
to the private sector if we are allowing these things to
happen. I think we need to address that directly in the ways
that we are able to do this such as what is our disclosure
policy like, how does our disclosure process work. We can
compare that to what some private-sector people do. And ours
compares very favorably.
In terms of the incidents of this happening, it is not
possible to compare it. And, again, I think that is irrelevant.
The fact that it happens once is too often in our system and we
need to be working in the direction of this not being able to
happen ever again.
Mr. Reyes. I understand.
Dr. Petzel. It is very hard to compare. I just have to say
it is very hard to compare.
Mr. Reyes. Well, first, but my point is and you are right.
Even one instance is one too many, but the reality is, and that
is why we have lawsuits against doctors, against hospitals,
sponges have been found stitched in after operations and
scissors and all those kinds of things, the reality is that
those kinds of things exist and happen in medical treatment.
My point was if we are going to, are we in essence holding
the Veterans Administration accountable realistically compared
to other medical systems or are we in a situation where perhaps
the VA needs to have an assessment, a self-assessment of the
quality of healthcare that is going on because perhaps
incidents are much higher than they would be in other kinds of
systems?
That was the point of my question. Yes, we can criticize
you for every single misstep, but, you know, we all should
strive for perfection, but the reality is perfection does not
exist in the medical world just like it does not exist any
place else.
We are seeing the shuttle delayed by a week or so because
of a mechanical problem. And that is in a system that is
designed by all the checks and double checks and triple checks
to be a zero defects operation. So that was the question that I
had.
Dr. Petzel. Congressman Reyes, I appreciate that. First of
all, as the gentleman from the GAO said, we have to be held
accountable for following the policies and procedures that we
have out there. I mean, we should, number one.
And number two is that whatever the comparison might be
between the private sector, we need to again be held
accountable for how we do. And I think that the goal has to be
that we do not leave any surgical sponges in a patient's
abdomen, that we do not fail in our reprocessing efforts with
any piece of reusable medical equipment. I mean, that needs to
be the standard against which we are judged, not necessarily
what goes on.
So I appreciate the concern and I appreciate the angst that
people feel about the failures that we have, but I do not want
to excuse those by saying that we are better than the civilian
sector.
We have to solve those problems internally by following or
having the right policies and procedures, by following those
policies and procedures, by having the kind of oversight that
is necessary to assure us that is happening, and then, as you
all have said repeatedly today, we need to hold people
accountable if they do not follow those procedures.
Mr. Williamson. If I could add to that, I think, Chairman
Miller, you hit the nail on the head initially when you said
that you could have all the requirements, you know, very good
requirements, but if people are not following them, therein
lies a problem. And let me just give you one example.
In July of 2009, VA came out with a directive for its
medical centers that said you shall have or you shall develop
devicespecific training for your RME equipment.
When we went into St. Louis in the fall of last year, they
had not developed that kind of training requirements for 80
percent of their RME. And that was 15 months after the
directive came out and it was 6 months, we were in there 6
months after the initial incident with the dental instruments.
So I think, again, it is tough to compare the private
sector with VA. I think VA in many cases had very good policy
requirements and very good policies, but you have to get people
to implement them.
The Chairman. Thank you.
Mr. Reyes. Thank you, Mr. Chairman.
I was just going to ask perhaps the question that needs to
be answered is, as we talk about accountability, how when
issues like this come up, how they respond to it, not just with
procedures, but accountability by the people that have been
involved which, by the way, when Dr. Petzel mentioned, the
Secretary has been in my district and I think Mr. Filner was
there with us, his goal is to have the best available
healthcare system on the planet, that has been articulated. We
just have to make sure that there is accountability.
Thank you.
The Chairman. Mr. Runyan.
Mr. Runyan. Thank you, Mr. Chairman.
And thank you all on the panel for your testimony.
I actually just chaired the DAMA Subcommittee hearing that
the Chairman spoke about earlier. And I want to go back a
little bit to what I ended up saying at the end. And I know the
Chairman and several other of the Subcommittee chairmen have
had meetings with Secretary Shinseki and we talked about
accountability.
The fact that we use the word oversight means there is a
total lack of accountability. It really needs to leave our
vocabulary because oversight means there was a mistake and we
need to move on from that because we all agree to that fact.
But going back to the dental scenario we were talking about
that everyone knew was going on, have we made any steps in
developing procedures and/or whistle blowing within that
management team and moving in that direction to really stop
something like that from happening because I think that is
another place where I know people are afraid of stepping on
toes of people senior to them?
And I really think it needs to be addressed because
obviously there is a situation where that did not need to be
happening. I think if you had procedures and protocols in
place, you could have avoided those situations.
Dr. Petzel. Congressman Runyan, you make an excellent,
excellent point. What is missing and what needs to be there and
needs to be in all of our medical centers is what is developing
in St. Louis and that is an atmosphere where people can come
forward, as you said, to the management, to whoever they need
to come forward to and say this is happening, this is wrong,
somebody needs to look at it. And that did not happen at
Dayton. And for a long time, that did not happen at St. Louis.
There is very good evidence that things are changing in St.
Louis. And my expectation is with the management team that is
now in place in Dayton we are going to create that same kind of
atmosphere.
Not only do people need to be able to come forward, but the
management team needs to be able to sit down and candidly
discuss what is going on in the medical center to keep each
other informed as well as hearing from what is coming up. And,
again, just to reiterate, that was not the case at Dayton.
Mr. Runyan. I think we can all totally agree on that. And,
you know, my experience with dealing with higher powers is, you
know, a lot of times, the truth hurts. And I think to be able
to have that communication, open communication in a team is
desirable no matter what team you are on.
And you really have to make a push forward and just take
the attitude of, you know, just the procedures that are in
there, the standards that are in there, and, you know, the
accountability you have personally to just get the job done and
not worry about what my superiors are thinking but knowing that
whether someone lower down has the backing of the Secretary who
is going to blow the whistle, they need to be informed and
assured that if they do blow the whistle on someone that it is
not going to cost them their job and/or their career.
With that, Mr. Chairman, I yield back the remainder of my
time.
The Chairman. Mr. Carnahan.
Mr. Carnahan. Thank you, Mr. Chairman and Ranking Member
Filner.
You all have been on this issue. You both have been to St.
Louis with a Missouri, Illinois bipartisan delegation and I
appreciate your commitment to this issue.
Also, I want to make really just a brief personal thanks to
Phylicia Woods, who is LA on my staff, who is going to be
leaving to go in the Peace Corps after this hearing. And I want
to thank her for all of her great work for my office and for
veterans in St. Louis, also the Veterans Advisory Committee
that we work with in St. Louis who are back home watching this
hearing today, and the many committed medical professionals at
Cochran that are committed to reforming that institution.
I spoke with Director Rema Nelson a little over a week ago.
She described to me that they are working on a comprehensive
turnaround plan, that they are working to incorporate many of
these recommendations from the GAO and the Inspector General
that can help this facility be what it needs to be for the
veterans in St. Louis.
My question for Dr. Petzel is, are you aware of this plan?
We were promised to get a draft copy of it. By the end of last
week, we have yet to receive that.
But I think it is critical to turn that facility around, to
have such a plan, to get buy-in from our veterans, our
community leaders because we want them to succeed. But I think
they have to have an aggressive plan to make that happen and
they have not had it up to now.
Dr. Petzel. Congressman Carnahan, I have not seen yet the
plan. As soon as we finish from this hearing, I will get in
contact with the director, Rema Nelson, and find out where it
is. And if she has promised a copy of it to you, we will be
sure that you get it.
[VA subsequently provided the following information:]
The St. Louis plan for the way forward was delivered by OCLA
on Tuesday, May 10, 2011.
Mr. Carnahan. To me, that is critical point going forward.
And to the point of reforming the adverse event disclosure
procedures, we may have the best scientific procedures there
are in the world, but if it does not reflect the human impact
on veterans, it is not a good system. So we have to have the
human side of that system in place.
And to Mr. Filner's point, at the hearing in St. Louis,
there was not a case management part of this in place. People
in St. Louis, they got a cold form letter like a parking
summons in the mail. That is it. And so that is when folks at
the hearing said at the request from many people at that
hearing that they would follow on and have the more personal
followup.
So I appreciate that that happened, but that is not where
this started.
Dr. Petzel. Thank you, Congressman.
I will have to go back and review my recollection of it. I
do know that we eventually ended up with case managers' phone
calls in addition to the letters. And you may well be right
that that occurred after the hearing. I just do not remember
the sequence.
Mr. Carnahan. I am right and that is the way it happened.
Dr. Petzel. Okay.
Mr. Carnahan. So we need to review it. That is the way it
happened.
Dr. Petzel. I will believe you.
Mr. Carnahan. Anyway, the other thing, in light of the
incidents at Cochran and other medical centers around the
country, at what point is the management evaluated at these
institutions and are they held accountable?
Again, I am very pleased that the management of Cochran is
developing this plan, but what we have heard from Dr. Daigh and
others there have been repeated visits, citations, problems
that have not been addressed starting with his work back in
March of 2007, another visit and evaluation in August of 2008,
May of 2009, March of 2010 and, of course, the Congressional
hearing in July of last year. A lot of these problems are still
lingering or not fixed yet.
And, you know, the question is, how many times do our
veterans have to fall in the same pothole before we fix it? And
so I want to have this system in place. I want to have a
comprehensive plan in place for Cochran. I want to get the
community and veterans to buy-in, but at some point, people
have to be held accountable if it is not implemented.
Dr. Petzel. I absolutely agree with you, absolutely agree.
Mr. Carnahan. Mr. Chairman, my time is up and thank you
again. And I yield back.
The Chairman. Thank you.
Dr. Benishek.
Mr. Benishek. Thank you, Mr. Chairman, Mr. Filner, and
thanks for the panel here.
I worked at the VA during the time of this colonoscopy
event and I was aware that they shut the whole thing down. So
it has some personal meaning to me.
And I guess what I have found here is I guess you talked
about this dental clinic a little bit, but are those people you
identified here in your testimony, you know, the dental
supervisors, the facility chief of staff, I mean, that dentist
in question, I mean, did those people--have those people been
punished or have they been fired or what exactly happened to
those people?
Dr. Petzel. I have to speak generically. The principal in
question has retired. And there is no way that we can prevent
somebody, even though we may want----
Mr. Benishek. Right.
Dr. Petzel [continuing]. To discipline them, from
retiring----
Mr. Benishek. What about the chief of staff?
Dr. Petzel. The chief of dentistry I believe has resigned
as well. And the chief of staff of that medical center, we have
not yet determined what the situation is going to be.
There are three administrative investigative boards going
on right now as it relates to Dayton and we do not have the
results of those yet.
Mr. Benishek. All right. This is the kind of thing that is
frustrating when there is, you know, a serious lapse of
leadership that you mentioned, and, yet, you know, a
significant amount of time has gone by and you have not decided
what to do with this guy or gal.
The other thing that disturbs me is Mr. Williamson's
testimony about the 15 months elapsing between the, you know,
the saying that you are going to be doing implementation of
protocol for cleaning RMEs and then he reports that 80 percent
of the--that has not been done in 80 percent of the places
after 15 months.
I would like to know who is responsible for that. I mean,
who is the guy in charge of that, implementation of that
process?
Dr. Petzel. Just a comment. There were six medical centers
that they reviewed out of 152. And I do not know where those
medical centers were. If the GAO is willing to identify them,
we would be delighted to go in and look and see what the
problems were and what happened.
Mr. Filner. Why didn't you ask them before this?
Dr. Petzel. I beg your pardon?
Mr. Filner. Why didn't you ask them to identify the medical
centers?
Dr. Petzel. I just got the GAO report.
Mr. Benishek. Well, it is just frustrating to me to have--
you know, we have two agencies of the government here that sort
of conflict. And, you know, Mr. Williamson seems to identify an
area of leadership, that there is something wrong, where there
is 15 months and now we--I cannot--how do I understand this
information. You are saying one thing. He is saying another.
And we are trying to decide how to best treat our veterans.
I think we definitely need to followup on this, you know,
from this Committee further and make sure that there is, you
know, not only at the chief of staff level but higher up in the
chain of bureaucracy, that we have effective leadership and
accountability for those people at each of those higher up
positions.
Mr. Williamson, did you have a comment?
Mr. Williamson. By the way, we went to Albany, Cheyenne,
Detroit, Miami, Palo Alto, and St. Louis.
You know, obviously we cannot travel to 90. And what we try
to do when we go to a location is we look for systemic problems
that transcend one facility. So while you only may go to a
small number, you are verifying that something is missing
throughout the system. So that is kind of the methodology that
we use.
I have to say that as most of the Members here who have
been a recipient of GAO reports know, we have a very rigid and
rigorous process for verifying our information. And all the
things that I have told you in the report and in my opening
remarks, VA has agreed with. We have an exit conference with
VA. We give them 30 days to comment and so on. And we verify
that pretty rigorously.
So I do not think Dr. Petzel is disagreeing with the 80
percent figure I used. I think he is probably coming from a
different way. But, you know, accountability is our middle
name. And so we are pretty careful, you know, about being
right.
Mr. Benishek. Well, thank you for your answer.
I just want to try to follow up with this at a later date,
so I do not lose track of this kind of information. I
appreciate your comments and yield back the remainder of my
time.
The Chairman. I was just looking at a copy of the GAO
report where there is a letter from Mr. Gingrich, Chief of
Staff, saying VA has reviewed this report and appreciates the
opportunity to comment on the draft.
So VA had seen the draft, correct?
Dr. Petzel. Just got it.
The Chairman. You saw the report. This is talking about the
draft.
Dr. Petzel. Oh, the draft. Yeah, I am sure that it was
reviewed here. I cannot recollect that I saw it, but, yes.
The Chairman. You have not reviewed the draft?
Dr. Petzel. I cannot recollect that I did. That does not
mean I did not. I just do not know.
The Chairman. If there was a report entitled ``Weaknesses
in Policies and Oversight Governing Medical Supplies and
Equipment Pose Risks to Veteran Safety,'' you would not
remember that you saw it?
Dr. Petzel. I might not, no.
The Chairman. I hope you did. I hope you did or somebody at
VA did.
Ms. Wilson, you are next. Thank you for joining the
Committee today.
Ms. Wilson. Thank you, Chairman Miller and Ranking Member
Filner.
I am new to this and I inherited this from my predecessor,
I am from Miami, Kendrick Meek. And so my following of this
debacle was by reading the Miami Herald.
And then my great Congresswoman Ros-Lehtinen invited me to
a tour of the VA hospital and a meeting with the people there,
with the administrators there, and then a press conference.
And at the meeting, I was really shocked by the cavalier
attitude of the administrator of the hospital and the way she
was going about answering the questions.
First of all, I found out that there were five people who
contracted HIV-AIDS (acquired immune deficiency syndrome), HIV,
eight hepatitis C patients, and one hepatitis B. We are not
sure whether it was from the instruments or but they have it
and they were tested with the unsterilized instruments.
So my question to her was, where are these people now and
what are they doing. And no one at that meeting had an answer.
No one could tell us what was happening with these particular
patients who were infected.
So I asked them to assign one person from the hospital to
be in charge of, sort of like a case worker, to make sure that
they were being treated, that they were following up with it,
and to get back to us and let us know what was happening.
So we got a letter saying that they had followed up with
all of them except four. And they could not find these four.
And they could not find the--they could not--four were--came in
for one treatment and then--I mean, two and then two they could
not find at all.
So my concern was that these two people, and they did not
identify which two they were, they did not identify which
malady they contracted from the hospital, and I am just
wondering for their safety and the safety of the public is
there any way that we should include the Florida Department of
Law Enforcement (FDLE) or the Federal Bureau of Investigation
(FBI) or the local authorities to try to find these people,
even private investigators, so that they would know that they
are infected and they, in fact, should have the opportunity for
treatment. That is the first question.
The second question has to do with Ms. Berrocal who is the
woman that was in charge of the hospital. It is my
understanding when this debacle first occurred she was
reassigned and someone from Jacksonville took her place.
Before she was put back into her place at Miami Hospital,
there was supposed to have been a report and some sort of
evaluation that was supposed to be released before she was sent
back to her position.
She was sent back to the position. There was no report
done. The Miami Herald, through a public records request, asked
for this report and to date, they still do not have it. And she
is still there.
Are you aware of all of these circumstances at the Miami
Veterans Hospital?
Dr. Petzel. I am aware of them, Congresswoman. There was a
report. And Ms. Berrocal is back at the Miami VA Medical
Center. I do not recollect the specifics of what was in the
report, but we can certainly resurrect that and see.
I would say that I think that Congressman Ros-Lehtinen and
others would agree that Miami is really beginning to turn
around, that the atmosphere and the practices of that hospital
are really quite improved over what they were when we
originally had the colonoscopy incident several years ago.
Ms. Wilson. My question has to do with finding the patients
who are unaccounted for. What can we do to find them at this
point?
Dr. Petzel. That is a good question. And I honestly do not
know. I know that the medical people follow up. I do not think
that they use private investigators, the police, or the FBI.
That is certainly something that we can look into if we still
are not able to contact those last two patients. And we will
look into that.
Ms. Wilson. Okay.
The Chairman. Thank you, Ms. Wilson.
I would like to use the Chairman's prerogative if I would
and beg the indulgence of the Committee Members. And since we
are dealing with Miami, which Ms. Wilson has been talking
about, I would like to go ahead and recognize Chairman Ros-
Lehtinen if she would to continue the questioning regarding
Miami.
Ms. Ros-Lehtinen. Well, thank you so much, Mr. Chairman and
Mr. Filner. Thank you for your leadership on this issue that
has been ongoing. It is so frustrating for so many of us. And
Mr. Under Secretary, you said you are doing better, but you
continue to find patients who were not notified in Miami, 12
additional names this past December. You state that excellent
way of notifying industry standards, those kinds of phrases.
And while I am happy that the VA is making efforts to
reform its procedures in the area of reusable medical equipment
and in notifying at-risk patients, we have been down this path
before. We are so frustrated. Ms. Wilson, Mr. Rivera, Mr. Diaz-
Balart and I.
In 2009, the Miami VA, as you know, notified over 2,400
veterans that they may have been at risk for infectious
diseases. Then a year later during a review of the VA's
facility logs, a year later an additional 79 veterans were
discovered to have been at risk. And now just this past
December where Ms. Wilson was talking about another 12 names
were discovered in an third review. Of these veterans, 17 have
been tested for HIV hepatitis B or C. It doesn't mean that it
is cause and effect, but it is very alarming. So over these 3
years, the list has kept growing.
Members have previously sat in this very Committee room,
were assured by VA that the Administration was taking action to
correct this previously failed policy. This has not happened,
those steps have not been put into place.
The VA Central Office initially left it up to the Miami VA
to identify at-risk patients, and I would like to ask these
questions.
Will another review, if we were to do another review, find
more at-risk patients? What degree of confidence do we have
that every time you have done a review you have found
additional folks who have fallen through the cracks? I don't
have confidence that the entire pool of at-risk patients have
been identified.
Secondly, are there now oversight mechanisms in place at
the VA Central Office where an independent authority will take
charge and make certain that a local VA like Miami will
meticulously review patient files to identify those who require
notification? Or is the attitude of the Central Office things
are going well, patients are being identified, and all systems
go?
And number three, so here we are again, Members are being
told that the VA has taken steps to eliminate the problems from
the VA centers, and if additional names are found or if it is
discovered that facilities continue to use improperly
sterilized equipment what then? What steps will be taken?
And I share Congresswoman Wilson's frustration. We have had
so many meetings about the follow up, and I remember the first
meeting that we had, and that was with her predecessor, Mr.
Meek, and we made this oh so brilliant suggestion that perhaps
they could go door to door and knock on the veteran's home,
apartment, wherever the veteran is, and they said, oh, that is
a good idea. And we are just so brilliant that way. And so they
said, okay. So they got back to us and they said, yes, we have
knocked on the doors. And then we kept asking, okay, of those
you have identified and you have knocked on their doors, have
each of these veterans been informed that they can get
treatment? Have they turned the treatment down?
And I understand that there are privacy concerns. We are
not asking for their names and their addresses, but they cannot
tell us, at least they haven't told us. They have not told us
this is the pool, these have been notified, these are under
care. We have no degree of confidence that they are in fact
getting care. We don't have to force someone to get care, but
we are talking about community health problems if these
veterans don't get the care.
So it is not just that veteran, it impacts the entire
community. You can't force them to get care, but you can
certainly work with that veteran to have that veteran
understand how serious this is, how it can impact the
community, and let us know that those veterans are indeed
getting care.
But I want you to understand how frustrated we are that we
have these meetings once and again and again, and honestly we
are saying this is water, and they will say, oh, okay this is
water, and it is very patronizing to us, because we know that
they must know more. I pray that they know more than they are
telling us. I pray that the veterans are getting the treatment
that they are getting, but they are not telling us.
So, I would like to say, with a degree of confidence, to my
constituents this problem really has been worked out after all
of these years, but I don't have that confidence, but I thank
Ms. Wilson for everything that she has been doing and Mr.
Rivera, Mr. Diaz-Balart, we are all united, we have a very
united delegation on this, and I thank the Chairman and the
Ranking Member for being such fearless leaders on this.
I would like to see if you could answer those questions.
Are we going to do another review in Miami? Do you have a
degree of confidence that every at-risk individual has been
identified, that there has been some followup care, that
everything really is what it should be? And if it turns out
that it isn't what then?
Thank you, Mr. Chairman.
Dr. Petzel. Thank you Congresswoman. I can answer those
questions. First let me start with the last.
We can provide you with information. Again, not specific
names, but about the number of people that have been contacted,
the number of people that are under care, and that is available
and we will certainly get that to you.
The second thing is when they are notified part of that
notification involves one of the consequences of this potential
exposure and what are the remediations so that if somebody
feels as if this indeed was the cause of their contracting HIV
or hepatitis C they have a legal remedy, and every single
person that we notify that is positive is told about that legal
remedy.
In terms of the----
Ms. Ros-Lehtinen. And let me ask you, when you say that we
can get you that, that is the same thing that happens to us
when we meet with them. They will say they can get it to us as
if we were meeting on what to order for lunch. I mean that is
the purpose of our meeting, so that is the information we want,
and then after every meeting they say we will get you that
info, so that is the purpose of what we want. All of those
individuals without any names where are they getting care?
Dr. Petzel. We can get that to you within a week.
The second question involved the process and how certain am
I that we have identified and notified everybody. And I am as
certain as I am going to be, that we have done that.
We learned a lot in the Miami process, just to reiterate.
Initially that was the identification of who should be notified
was the responsibility of the facility, and they made a
decision to use a computerized medical record and the coding
that was in there to identify the people that had
colonoscopies. It was found out several months, almost a half a
year, after that notification someone called up and said, I had
a colonoscopy during that period of time but I wasn't notified.
So there were some errors, if you will, in the coding that
occurred that went into the computerized medical record. That
was the second iteration.
And then the third iteration had to do with a logbook that
shouldn't have been there but was used and had in it again 11
patients that weren't on the computer list because those 11
patients had been inappropriately coded when they went into the
computer list.
But the primary lesson we have learned here is that we have
a Central Office team now that does the process of identifying
who should be notified.
This event is something that occurs hopefully once in the
lifetime of a medical center. They have no experience in
developing the material that you need to get a list, so we have
now made that a Central Office function.
We send a group of people down who have experience doing
this and have done this in other circumstances and they have
become responsible for developing the list of people that need
to be notified.
Ms. Ros-Lehtinen. Thank you. And Mr. Chairman, just one
last note. The Miami Herald, Fred Task, has been doing an
excellent job on this and I hope that he would not need to file
another Freedom of Information Act to get information about
these vets. I would hope that you would share information with
our community, not names and addresses, but what is new on the
status. It is a big concern with them.
[The VA subsequently provided the following information:]
Of the 17 patient positives, one (1) expired from other
causes. One (1) patient is currently being followed and treated
at a VA Medical Center in Arkansas and was last seen on April
9, 2011. One (1) patient is currently being followed by his
private physician in the Miami area. The remaining fourteen
(14) patients are being followed by the Miami VAHS. Of those,
eleven are actively receiving care. The remaining three
patients have not responded to VA's outreach efforts. We will
continue to make sure that they are aware of our services and
remain available to treat them if they choose VA care.
The Chairman. Thank you, Madam Chairman. Mr. Clay.
Mr. Clay. Thank you, Mr. Chairman, thank you for conducting
this hearing.
Let me personally thank you and Mr. Filner as well as the
Committee staff for giving the time and attention to the issues
that have arisen over the last year or more at Cochran VA
hospital in St. Louis in my district.
Let me start with Dr. Daigh or Mr. Williamson. Have the
sterilization problems in the dental clinic at John Cochran
hospital been resolved?
Dr. Daigh. Yes, sir, I believe they have.
Mr. Clay. Thank you. You think they have.
Okay, now what was the final source of the contamination in
the surgical unit? What was the cause? Can either one of you
speak to that? Or can you, Mr. Petzel?
Dr. Petzel. I think I can. I don't believe, Congressman,
that they have had any experience with that, and I assume that
you are referring to the fact that there was some discoloration
discovered on surgical instruments by one of the scrub nurses,
and we then stopped surgery in St. Louis while we tried to
discover what that discoloration was.
There was not a sterilization problem or an issue, those
instruments were sterile, and eventually we came to the
conclusion that it was a combination of events; the fluid that
was used in pre-wash and the filters on the steam sterilization
unit. When the solution was changed and when the filters were
changed we were able to get rid of the discoloration and that
started up again.
This is something that we discovered and I think was
managed quite well.
Mr. Clay. Okay, Doctor, was that a vendor issue or was it
inside the hospital?
Dr. Petzel. Well, it was inside the hospital insofar as the
instruments were being sterilized in the hospital, but again,
it had to do apparently to the fluid that was being used and to
the filters in the sterilization.
Mr. Clay. Which caused the spots on the instrument.
Dr. Petzel. Which caused spots on the instrument, correct,
discolorations, but not an issue of sterilization.
Mr. Clay. Okay. Let me ask you, why does Cochran VA Medical
Center consistently receive a low patient satisfaction when
compared to other VA facilities, and why does this problem
persist year after year?
Dr. Petzel. Let me take a few minutes to explain this.
Mr. Clay. Go right ahead, I have a little time here. Go
right ahead.
Dr. Petzel. When you look across the country inside or
outside the VA wherever you have customers, wherever you have
patients the satisfaction of the individual patients with their
care is a direct reflection of employee satisfaction. There is
a very, very strong relationship. If you have a satisfied
workforce that enjoys their job and is doing it, you know, with
a smile, so to speak, you are going to have generally speaking
a group of patients that are going to also feel good about
their experience.
And I think there was a history at John Cochran, again
before my time, where we had an employee group that was not
particularly satisfied or happy in the workplace.
Mr. Clay. Now wait a minute, let me stop you. That tells me
as a cultural issue----
Dr. Petzel. Absolutely.
Mr. Clay [continuing]. In that facility.
Dr. Petzel. Absolutely.
Mr. Clay. Have you addressed it and how?
Dr. Petzel. I believe that we are addressing it. Rema
Nelson, the new director there has created a much more open
atmosphere where people can talk to her about problems, she is
approachable, she is out walking around that hospital
continuously testing the waters, taking the temperatures,
seeing how things are happening.
We hear now from the union and from the service
organizations that the atmosphere there has changed, that this
is a better place to work, a happier place to work.
My hope and expectation is that this is going to be
reflected in the patient satisfaction scores.
Mr. Clay. When will we know that?
Dr. Petzel. Every month we do a series of inpatient and
outpatient satisfaction scores, so I am hoping relatively soon.
I don't know how long. I don't know how long, but I am hoping
relatively soon we will see a change.
Mr. Clay. Okay, my concern is this, Doctor. If we cannot
improve conditions perhaps it is time for the St. Louis region
to try perhaps a voucher system for patients to receive medical
attention from our two world-class medical facilities that are
a stones throw away from the VA Cochran.
If you cannot do the job for these people that deserve it,
perhaps we need to look at another system to deliver medical
care to them.
Dr. Petzel. My expectation is that we are going to see
improved patient satisfaction scores at the John Cochran.
Mr. Clay. As soon as you receive it share that with us.
Dr. Petzel. We absolutely will.
[The VA subsequently provided the following information:]
Patient Satisfaction at St. Louis VAMC, 2011
National Satisfaction Scores (SHEP)*
------------------------------------------------------------------------
INPATIENT SATISFACTION 2011 (%)
------------------------------------------------------------------------
John Cochran 42.3
------------------------------------------------------------------------
Jefferson Barracks Cases too low
------------------------------------------------------------------------
Overall 42.3
------------------------------------------------------------------------
------------------------------------------------------------------------
OUTPATIENT SATISFACTION 2011 (%)
------------------------------------------------------------------------
John Cochran 54.7
------------------------------------------------------------------------
Jefferson Barracks 40.3
------------------------------------------------------------------------
Overall 49.1
------------------------------------------------------------------------
Because of the time lag between the time of care and the survey report,
the FY 11 scores reflected here only data from October through
January. Until second quarter data is obtained a comparison between FY
10 and FY 11 is difficult due.
Quick Card
In order to provide some real time information on customer
satisfaction, the Medical Center has implemented a Quick Card
survey system. Here are the results of the Quick Card surveys
from December 2010 through April 2011:
------------------------------------------------------------------------
QUICK CARD QUESTIONS (yes / no) YES RESPONSES (%)
------------------------------------------------------------------------
Courtesy of Staff 97
------------------------------------------------------------------------
Timely Service 88
------------------------------------------------------------------------
Experienced Delay 25
------------------------------------------------------------------------
Facility Appearance 94
------------------------------------------------------------------------
Professional Appearance of Staff 97
------------------------------------------------------------------------
Mr. Clay. Thank you. Thank you, Mr. Chairman, and I yield
back.
The Chairman. Ms. Buerkle.
Ms. Buerkle. Thank you, Mr. Chairman, and thank you to you
and to Ranking Member Mr. Filner for your taking the lead on
this issue, very important issue, and thank you to our panelist
today.
I am Chairman of the Subcommittee on Health. I am a
registered nurse and I also am an attorney and I represented a
major teaching hospital for many years, so this is all of very
particular interest to me.
I think the first thing that concerns me is when we refer
veterans to our healthcare veteran facilities that they have
some sense of what Dr. Roe mentioned, trust, and that we are
referring them to a system that will take care of them, and at
the very least that care should be what the industry offers.
I think you are all familiar with JCO, every hospital
hunkers down when The Joint Commission comes in and reviews all
of the processes, every system, every process, and they hold
the hospital accountable and everyone prepares for that and
there is that accountability factor.
So I guess my first question, Dr. Petzel, is what in the VA
system is analogous to the JCO reviews that a hospital has to
undergo every few years?
Dr. Petzel. Well, Congresswoman, first of all we do undergo
the Joint Commission reviews just like everybody else, so our
hospitals are all accredited by the Joint Commission.
Number two, and the process has changed recently insofar as
now you don't know when they are going to come, and what
happens is what we call continuous readiness. That is you have
to be ready for them to drop in at any moment. They do not
announce that they are coming and they show up at your doorstep
on a Monday morning or a Tuesday morning and begin their
survey.
It is a tremendous improvement from my perspective, because
previously we all dropped everything for 6 months before the
Joint Commission came and cleaned the floors and uncluttered
the hallways and did all those sorts of things and now you have
to do that all the time, which is the way it should be.
We also have the SOARS process, which is an internal within
the Veterans Health Administration (VHA) process of inspection
that occurs. The OIG does their Combined Assessment Program
reviews. Every 3 years they go to every facility and are much
more thorough than the Joint Commission in terms of oversight
and looking at us. And those are probably our two biggest VA-
related internal reviews like the Joint Commission.
Ms. Buerkle. Well, then how do situations like these occur
with that kind of oversight, with that--kind of what happens
that these situations--the VA finds themselves in these
situations? Any private hospital would have corrected it, it
wouldn't happen again. And these instances continue to occur.
And if you have this oversight in place why aren't corrections
being made?
Dr. Petzel. Well, at each one of the medical centers,
Congresswoman, that are involved those corrections have
occurred. We don't have a recurrence of any of these incidents
at any of the medical centers that were--of these four that we
have been discussing. They have cleaned up their act, they have
changed their practices, and they are doing the things that
they need to do to appropriately sterilize the equipment.
I think that why this has happened in our system, we are a
national integrated system, everybody should be aware of what
is going on, and I think again there is a failure of
leadership, people not holding other people accountable, people
not checking to be sure that indeed everybody does have
training in the SPD, indeed everybody does do their job. We are
supposed to watch somebody do their training, and I think when
these things break down it is a failure of those things to
happen. It is again a failure of leadership.
Ms. Buerkle. I would submit that if it is happening in any
of the VA hospitals and it hasn't been corrected we are looking
at a hospital system, and so the policies and procedures should
apply to all. So if there is a problem here that correction
should take place in all of the hospitals, and apparently that
hasn't been done.
Dr. Petzel. And I absolutely agree with you, Congresswoman,
that is absolutely the way this system should work.
Ms. Buerkle. Just briefly in my few seconds that I have
left. When we look at medical malpractice, the question is also
asked what is the deviation in the standard of care, and that
is how we gauge whether or not there is malpractice.
What is the standard of care that the VA hospital, what
standard of care would you be adhering to? Which one standard
of care? I hear lots of different oversights, but what is the
standard of care you apply?
Dr. Petzel. I am sorry, Congresswoman, I don't quite
understand the question.
Ms. Buerkle. Well, I assume the VA hospital adheres to one
set of processes and one set of procedures based on something,
and whether it is JCO standards or what--it sounds to me like
it is rather arbitrary.
Dr. Petzel. First of all sort of at the top would be the
Joint Commission standards. We are again accredited by the
Joint Commission, every one of our 152 medical centers and 871
outpatient clinics have that accreditation, so that would be
one standard.
Second, we have policies and procedures that are much more
specific than what the Joint Commission would be looking at for
many, many things, and we adhere to those standards.
And I think we would not get argument either from Dr. Daigh
or Mr. Williamson about our policies and procedures. We have
good policies and procedures that are at the top. The problem
is adherence to those policies and procedures. The problem is
our people following those policies and procedures.
So I am not as concerned about the standard that we are
setting as I am about are we adhering to that.
Ms. Buerkle. I am out of time. Would the Chairman just
allow one more question?
The Chairman. Very short.
Ms. Buerkle. Dr. Daigh, would you agree with what Dr.
Petzel is saying?
Dr. Daigh. Yes, ma'am. I believe VA has really quite
excellent policies and procedures that are in most cases
industry standard and often put together with the use of
experts who spend part of their time at VA facilities and part
of their time at the various universities. So much of the staff
at the VA is medical school plus VA, so I think their policies
are correct.
As I indicated in my statement, I think the issue is
execution, that is doing what you are supposed to do every day.
Ms. Buerkle. Thank you, Mr. Chairman.
The Chairman. Mr. Turner.
Mr. Turner. Thank you, Mr. Chairman. I want to thank the
Chairman and the Ranking Member for their tenacity on this
issue, but I particularly want to thank the Chair.
Chairman Miller has taken a particular interest in these
issues. His care for veterans has been evident throughout his
work on this Committee, but in these instances where these
specific infractions came to light Chairman Miller has dived
in, he came to my community and has personally read all the
documents that are involved, and I want you to know that if it
hadn't been for Chairman Miller, I don't think my community
would even have the information that it has today.
The VA has stone-walled my community, they have not been
responsive. If it wasn't for this Committee beginning to force
the VA to work with my community, I honestly believe that we
would have even less than we have today.
Mr. Petzel, you said this is unquestionably a failure of
leadership. Then when you were asked about accountability for
that leadership, what happened to those people who would have
been that failed leadership, you really didn't know what had
happened to the people in this chain.
We have in my community a dentist who for almost 2 years
violated the standard care of practice, not sterilizing
equipment, taking things from people's mouths, using the same
gloves the entire day while working on people, not cleaning
instruments and tools that he used on numerous people, and this
isn't something that was going on for a couple decades in
secret, it was visibly obvious, it was in a clinic that it
occurred, that was located directly above the director's
office. This wasn't even in an isolated, located facility away
on campus. This is something that was known.
So when you say failure of leadership I agree. The dentist
in question though got to retire, the Chief of Staff got to
retire, the director was promoted.
So if it is leadership, if we go up the chain of command
where it goes from the patient to the dentist to the chief of
staff to the director no one has been held accountable. So we
have a failure of accountability.
We also have a failure of being able to complete an
investigation. The OIG was unable to talk to the dentist in
question because he retired, or the chief of staff, or even the
complainants because the people having left the system. So we
don't have accountability and we don't even have the ability to
do a complete and total investigation.
The review that was undertaken by the VA was pretty much
done in secret. The review board that the VA empanelled and
even the testimony that was taken when it was released to the
community, the names of all the individuals were redacted, and
they were redacted so we wouldn't even know who it was that you
were relying on to review what had occurred in advising the VA
as to what patients to be notified or even what their care was
supposed to be.
I contacted the Greater Dayton Hospital Association for my
community, your regional peers, and I asked them to review what
you did provide the community. They provided a report basically
saying one, that all of the information needs to be released.
There is a number of documents that are really critical for our
community to understand whether or not you are taking
appropriate precautions for those that were subjected to a risk
of HIV and for hepatitis.
Secondly, they disagree with your scope of the patients
that are notified. They believe that many more people were
subjected to exposure to HIV and hepatitis, and so they have
asked for in addition to an expansion of the documents that are
released for additional patients to be notified.
Now I appealed your redacting of the documents that were
provided to us. I was told that you wanted to protect those who
were part of the review board so they would not be subject to
harassment.
You know in our court system we don't let juries stand
behind a screen. We require that they be held accountable to
the community for what their decisions are on things that are
very, very significant judicially and to people's lives.
There is no reason why you should be empanelling review
Committees that are then done in secret, that we all then have
to guess as to what their motives were, their backgrounds,
their experience, or their basis for their determination.
When I asked for the non-redacted version to be released,
you answered that even the dentist's name in question should
not be released because of the nature of the investigation and
seriousness of the allegation, the dentist could be subject to
harassment or worse. You actually indicated that you didn't
want to release it because he could be subject to annoyance or
harassment. Annoyance or harassment like being subject to the
risk of HIV and hepatitis? I mean this is incredibly serious,
and the VA is not being open with my community or I think even
giving an ability for proper oversight from Congress.
I have three questions for you. You said this is a failure
of leadership, now we are going to come to the issue of your
leadership.
Are you willing to expand the number of patients that were
notified, tested, and received treatment as a result of the
actions that occurred at the Dayton VA? Are you willing to
release the documents that were requested by our Greater Dayton
Hospital Association so that they can review your investigation
to these practices? And are you willing to release the non-
redacted review transcript from your review board so that we
can actually evaluate your approach on this issue?
Dr. Petzel. In answer to the first question, we are and
will go back and look at the process that we went through in
terms of identifying the patients that needed to be identified.
At this present time I stand by the decision that the
clinical review board made as to who should be notified, but we
are going to look at that.
Number two is that we have made available to the Committee,
to the Chairman all of the material that they request. We
cannot release some of this material to the Greater Dayton
Hospital Association. We cannot release----
Mr. Turner. Sir, hold on a second. I know my time is brief,
but if you would permit it, Mr. Chairman.
I have the documents of the Freedom of Information Act
provisions that you are standing on, they are all
discretionary, and when I was briefed by your staff in my
office they admitted it was discretionary. So please don't say
that you cannot release them, because of course you can. There
is no patient information that is being protected here, because
no patient information is included in what is been being asked.
It is procedures, policies, and actions.
Dr. Petzel. I am sorry, Congressman, but I have been told
by our attorneys that we cannot release to you, or to the
community, those unredacted documents.
Mr. Turner. Okay. Well then they were in my office, your
attorneys by the way, if you and I meet in my office with your
attorneys and your attorneys say that it is discretionary does
that mean that you are willing to release them? Because you are
not prohibited from releasing them.
Dr. Petzel. If they tell me that they are releasable----
Mr. Turner. That it is discretionary.
Dr. Petzel. Beg your pardon?
Mr. Turner. That it is discretionary within your discretion
you will use that discretion and release them.
Dr. Petzel. I would have to then consider doing that, but
that is not what I have been told.
Mr. Turner. You are not required to maintain the redaction
and you may release those documents.
So I would expect that you would use that discretion that
you have and release them based upon your testimony today.
And then my third question. You were answering on the
redaction and the release of the documents. Is it combined,
both on the issue of redaction and release the documents?
Dr. Petzel. Correct.
Mr. Turner. Okay. Thank you. Mr. Chairman, thank you for
your work on this.
The Chairman. Thank you, Mr. Turner. Mr. Bilirakis.
Mr. Bilirakis. Thank you, briefly. Thank you, Mr. Chairman,
I appreciate it.
Question for the panel. Should a person acquire an
infectious disease and it is a result of a mistake by the VA
health system, what resources are available to that individual
besides the legal remedies that you mentioned?
Thank you.
Dr. Petzel. That is an excellent question, Congressman.
First of all you can never establish for sure that it was
associated with the event or that it wasn't associated with the
event. The assumption has to be that if they had a colonoscopy
with what was felt to be an unsterilized colonoscope and
developed hepatitis C that that was responsible, so we assume
the responsibility for anybody that is converted.
Two things are fundamentally available. They are eligible
for and will receive healthcare from us for as long as they
need it for the rest of their lives if that may be the case.
Two, is that they have a legal remedy insofar as they could
file what we call a tort claim and recover damages if the court
indeed believes that there is a relationship between our event
and their disease.
So healthcare on the one hand, compensation on the other.
Mr. Bilirakis. Does it require filing a lawsuit to receive
any sort of compensation?
Dr. Petzel. In most instances, yes, but let me ask one of
the people here with me. I think that we may be able to
service-connect somebody who develops a disease because of
something we did. Is that correct? They believe so. Let me get
back to you specifically about that.
Mr. Bilirakis. Okay, please do.
Dr. Petzel. I will.
[The VA subsequently provided the following information:]
The statutory provision at 38 U.S.C. 1151 authorizes
payment of compensation for additional disability or death that
is not the result of the Veteran's willful misconduct and is
caused by hospital care, medical or surgical treatment, or
examination furnished to the Veteran under laws administered by
VA. To meet the qualifications of 38 U.S.C. 1151, the
proximate cause of additional disability or death must be:
Carelessness, negligence, lack of proper skill,
error in judgment, or similar instance of fault on the part of
VA in furnishing the hospital care, medical or surgical
treatment, or examination; or
An event not reasonably foreseeable.
VA may pay compensation under 38 U.S.C. 1151 for disability
resulting from hepatitis B and C, as well as HIV, if there is
competent medical evidence of record showing that these
conditions were proximately caused by either carelessness,
negligence, lack of proper skill, error in judgment, or a
similar instance of fault on the part of the VA in furnishing
hospital care, medical or surgical treatment, or examination.
Mr. Bilirakis. Thank you. I yield back, Mr. Chairman. Thank
you.
The Chairman. Mr. Filner.
Mr. Filner. Let me just go back to my original statement,
Dr. Petzel.
Again, you have said over and over that again that it is a
failure of leadership, and yet again, I think it is more
bureaucratic defensiveness and secrecy. We don't know that
there has been accountability.
I think we need to work with you and your lawyers to
develop a new way to give us some assurance these issues are
being handled. What you have given us today gives us very
little confidence that these personnel decisions are being
handled with some accountability. You gave us three examples of
something happening, mainly retirement, or I forget what you
called them. Three employees for all these years of problems?
Whether we can sit in executive session as a Committee and
talk to you about that, I don't know. I think we have to
examine that, Mr. Chairman.
We need a new process here because you are standing on
Civil Service protections, you are standing on secrecy, you are
standing on legal matters, and yet I don't care what the
private sector does, this is a public institution. We have to
get trust and confidence in a different way. The same legal
remedies are not available to someone with regard to a public
system any way. But I think we need to have a discussion about
how we do this. This is very, very unsatisfactory.
If you could tell us more and we could get more in a
setting with, perhaps, just the Chair and the Ranking Member of
either the whole Committee or a Subcommittee Executive Session.
We need to figure out a way to get a better handle on this
stuff, because we can't tell our constituents anything because
we don't know anything. Even if we knew something it would help
us to have confidence, and know it has been taken care of. I
can't say that to anybody right now.
So you need to find a way to give us the confidence to give
our constituents, and we would be happy to work with you. We
need a new way to do this and it is just not working the way it
is.
Thank you, Mr. Chairman.
The Chairman. I thank you very much. Are there any other
questions of the Committee?
I thank the panel for being here today. There probably will
be some questions that will be sent for the record. We thank
you for your testimony.
If the second panel will begin coming forward. We have two
more witnesses here to be with us today. Dr. Michael Bell, he
is the Deputy Director of the Division of Healthcare Quality
Promotion for the Centers for Disease Control and Prevention
(CDC), and Mr. Anthony Watson, Director of the Office of Device
Evaluation of the Centers for Devices and Radiological Health
for the Food and Drug Administration (FDA).
We thank you both for sitting through the testimony from
the first panel and the questions. We thank you for being here
today.
As you have witnessed, the patient safety incidents at VA
medical centers are complex and have wide ranging implications.
I look forward to hearing from you today on how we can take a
comprehensive proactive approach to patient safety for our
veteran heroes and for all Americans.
So with that, Dr. Bell, you are recognized for 5 minutes.
STATEMENTS OF MICHAEL BELL, M.D., DEPUTY DIRECTOR, DIVISION OF
HEALTHCARE QUALITY PROMOTION, CENTERS FOR DISEASE CONTROL AND
PREVENTION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES; AND
ANTHONY D. WATSON, BS, MS, MBA, DIRECTOR, DIVISION OF
ANESTHESIOLOGY, GENERAL HOSPITAL, INFECTION CONTROL, AND DENTAL
DEVICES, OFFICE OF DEVICE EVALUATION, CENTER FOR DEVICES AND
RADIOLOGICAL HEALTH, FOOD AND DRUG ADMINISTRATION, U.S.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
STATEMENT OF MICHAEL BELL, M.D.
Dr. Bell. Good afternoon Chairman Miller, Ranking Member
Filner, and other distinguished Members of the Committee. I am
Dr. Michael Bell, Deputy Director of the Division of Healthcare
Quality Promotion at the Centers for Disease Control and
Prevention.
Thank you for this opportunity to discuss the important
topics of preventing healthcare associated infections and
ensuring safe healthcare nationwide.
Healthcare associated infections are infections that
patients get while receiving care. These infections range from
those related to highly specialized intensive care procedures
down to infections caused by lapses in the most basic safe
practices, for example, reusing disposable syringes.
CDC estimates that roughly 1 in 20 hospital patients have
healthcare associated infection. These infections are often
severe and can kill people, and in hospitals alone they result
in an estimated $26 to $33 billion a year in excess costs.
Fortunately we know how to protect patients from many of these
infections, and if we can protect them then we must protect
them.
Healthcare associated infections can occur in any
healthcare setting. These settings include hospitals, dialysis
centers, ambulatory surgical centers, and nursing homes.
Medical care that used to take place only in hospitals is
now increasingly being delivered in non-hospital settings. As
that shift occurs, we are seeing a growing number of outbreaks
in those settings. These are settings where infection control
programs and oversight are generally less rigorous compared to
hospitals.
Today I will focus my remarks on healthcare associated
infections that happen because of lapses in basic infection
control.
Infection control refers to the established collection of
rules and procedures designed to prevent the spread of
infection during healthcare, including basic safe practices
such as not reusing syringes or appropriately sterilizing or
disinfecting equipment. Lapses in those basic safe practices
are entirely unacceptable. These are never events.
Unfortunately, we continue to see egregious errors that have
resulted in transmission of serious infections. As a result CDC
is working in a number of ways to evaluate the problem and
launch prevention strategies to stop these lapses from
occurring.
CDC has worked with State and local health departments
across the country and identified numerous lapses in basic
infection control over the past several years. Recent examples
include using the same syringe for more than one patient,
accessing a shared vial of medication with a used syringe,
using contaminated equipment for diabetic testing, inadequately
cleaning and disinfecting medical equipment, such endoscopes,
and improperly reusing medical devices like biopsy needle
guides. Such practices are simply unacceptable, unfortunately
they are happening across the spectrum of healthcare,
particularly in non-hospital settings. More must be done to
ensure that correct infection control practices are maintained
wherever medical care is delivered.
CDC is actively engaged in eliminating these events. Our
current efforts include developing national infection control
guidelines and working with Centers for Medicare & Medicaid
Services (CMS) to ensure that they are followed, developing
checklists for State and CMS surveyors to evaluate facilities
infection control practices, responding to outbreaks and
emergent patient safety threats, educating healthcare personnel
and patients about basic infection control requirements, and
promoting the development of safer medical devices.
Our ultimate goal is to ensure that all patients receive
safe care in every healthcare setting. We use CMS oversight and
payment policies to drive adherence to CDC's infection control
guidelines; however, when there is a lapse in infection control
patients must be protected from harm. Local and state
authorities are used to halt the unsafe medical practice. It is
then necessary to identify which individuals were exposed and
to promptly notify them so that they can receive appropriate
care.
Sadly in the past 10 years, over 100,000 patients have had
to be notified that they were exposed to infection control
lapse related to the unsafe injections, even more patients have
been exposed to other areas such as improper sterilization of
equipment.
Ensuring appropriate infection control in all healthcare
settings is a priority for CDC. Our public health system is
crucial to ensuring safe care for patients, providing a unified
approach to implementing infection control, monitoring safety,
investigating and controlling outbreaks, providing oversight
and education, and researching new ways to improve healthcare
quality.
As we work toward elimination of healthcare associated
infections, ongoing vigilance is needed as new healthcare
settings and changing technologies create new challenges to
healthcare safety. CDC continues to address those challenges
working to ensure that our patients are safe in every
healthcare setting. We know how to protect patients from these
infections; they can and must be prevented.
Thank you for this opportunity to testify. I am happy to
take any questions you might have.
[The prepared statement of Dr. Bell appears on p. 67.]
The Chairman. Thank you very much, Doctor.
Mr. Watson, you are recognized.
STATEMENT OF ANTHONY D. WATSON, BS, MS, MBA
Mr. Watson. Mr. Chairman, Ranking Member Filner, and
Members of the Committee, thank you for the opportunity to
discuss reprocessing of reusable medical devices and the
importance of adequate reprocessing to protect patient safety.
Today, I will discuss the challenges to ensuring the safety
of reprocessed medical devices and describe actions FDA is
taking to address those challenges.
Reusable medical devices are devices that are designed and
labeled for use on multiple patients and are made of materials
that can withstand repeated reprocessing, including manual
brushing and the use of chemicals. Some examples of reusable
medical devices are surgical instruments, such as clamps and
forceps; endoscopes, used to visualize areas inside the body;
and accessories to endoscopes, such as arthroscopic shavers;
and laparoscopic surgery accessories, such as graspers and
scissors.
All reusable medical devices can be grouped into one of
three categories according to the degree of risk of infection
associated with their use. Critical devices, such as surgical
forceps, semi-critical devices, such as endoscopes, and non-
critical devices, such as stethoscopes.
Adequate reprocessing of reusable medical devices is a
critically important step in protecting patient safety.
Reprocessing is intended to remove blood, tissue, and other
debris to ensure that devices are safe for the next patient
use. Reprocessing can be both labor-intensive and time-
consuming, because most reusable medical devices require a
specific reprocessing regimen.
In general, reprocessing reusable medical devices involves
three steps: initial cleaning which is at the point of use;
transfer to the reprocessing work area where the device is
thoroughly cleaned; and disinfection or sterilization,
depending on the intended use of the device, its risk of
infection transmission, and the materials from which it is made
as well. The device is then stored or routed back into use.
Many factors contribute to reprocessing difficulties,
including device complexity, absence of best practices, user
error, and poor instructions on how to reprocess.
Manufacturers, healthcare facilities, healthcare
professionals, and FDA share responsibility for reducing the
risk of healthcare-associated infections, or HAIs, from
inadequately reprocessed reusable medical devices.
HAIs are infections caused by a wide variety of common and
unusual bacteria, fungi, and viruses during the course of
receiving medical care.
Under FDA labeling regulations, a device must have adequate
directions for use. This includes instructions on how to clean
and disinfect or sterilize a reusable device to ensure that it
is effectively prepared for its clinical use.
FDA applies its unique position and expertise to reduce the
risk of infection from reusable medical devices by evaluating
devices prior to marketing, identifying device designs that
facilitate proper reprocessing, assuring that manufacturer
instructions are clear, and promoting collaboration among all
stakeholders.
FDA also works with manufacturers to correct product
problems associated with reprocessed medical devices.
FDA expects manufacturers to design their devices to
minimize debris retention, provide complete and easy to
understand reprocessing instructions, and validate the
reprocessing protocols using clinically relevant soil.
Healthcare institutions should periodically assess
infection control practices in clinical areas, ensure that
those responsible for reprocessing understand the importance of
the job, and are given the necessary training to perform it
properly. Reprocessing staff should understand the distinct and
separate steps of reprocessing, and they should follow
reprocessing instructions provided by device manufacturers.
Physicians and nurses should consider that reprocessing
plays a role in device performance and follow up with the
appropriate chain of accountability, such as reporting adverse
events that may be related to inadequate reprocessing,
following guidelines established by professional societies, and
communicating with manufacturers regarding labeling issues and
ease of reprocessing.
While FDA believes that the risk of acquiring an HAI from a
reasonable device is relatively low and that the benefits of
these important devices outweigh their risks, we are taking a
collaborative approach toward improving the reprocessing of
reusable medical devices.
On April 29th, 2011, FDA launched the Reusable Medical
Devices Improvement Initiative to reduce the risk of HAIs from
inadequately reprocessed medical devices.
FDA's approach to addressing reprocessing problems focuses
on collaborating with other government agencies, manufacturers,
healthcare facilities, and healthcare professionals to
strengthen all steps in reusable device reprocessing by
fostering improved, innovative device designs to reduce debris
retention, strengthening the science of cleaning and high-level
disinfection or sterilization of medical devices, and ensuring
that healthcare facilities properly perform cleaning,
disinfecting, and sterilization.
Specifically, FDA has issued revised draft guidance that
updates and clarifies the recommended content of and review
procedures for medical device applications concerning the
labeling instructions for reprocessing reusable medical
devices.
In addition, this draft document provides more detail about
FDA's recommendations for the validation of processes intended
to support reprocessing.
We have also announced a public meeting to be held on June
8th and 9th to bring together key stakeholders, including
industry user facilities, standards organizations, healthcare
accreditation organizations, government agencies, and
professional societies.
This is the first in a series of conversations between FDA
and reusable device stakeholders to discuss factors effecting
the reprocessing reusable medical and FDA's plans to address
the identified issues.
Finally, FDA has developed a Web page that provides general
outreach about reprocessing of reusable medical devices to
educate consumer and healthcare professionals.
Reducing the risk of infection from reusable medical
devices is critical to protecting patients and is a shared
responsibility. By using its unique vantage point, FDA is
helping to address current problems with reprocessed devices
while facilitating improvements in innovative design in the
next generation of these devices.
Mr. Chairman, this concludes my formal statement. I will be
happy to address any questions you may have.
[The prepared statement of Mr. Watson appears on p. 71.]
The Chairman. Thank you very much, Mr. Watson. Is it safe
for me to assume that VA has been invited to your June
workshop?
Mr. Watson. Absolutely.
The Chairman. Thank you. Do you see a need for research
into technologies to develop indicators to improve the ability
to monitor the quality of reprocessing of reusable medical
equipment?
Mr. Watson. One of the elements we have introduced in our
initiative yesterday was a draft guidance. I apologize that was
actually Friday. That draft guidance contains information or
method validation and labeling for these devices.
In that guidance we talk about the science of reprocessing,
we get into the steps for reprocessing, we talk about different
methods of validation, and by doing that we hope that users
will be able to take that information and use it to improve
their processes.
So our role as we see it is to help facilitate
communication to help ensure that the right information is out
there for the devices, and as well to help the manufacturers
produce excellent labels so that people can understand what
they are actually trying to do in the reprocessing area.
Specifically we have also included information in there
that includes a human factors evaluation where users actually
have to use the labeling to determine whether they can
reprocess the device properly.
So our role as we see it is to help facilitate that
communication, that is what the workshop is about on June 8th
and 9th.
The Chairman. And I would like to ask one question for both
of you to answer. Mr. Watson, if you would answer it first.
What lessons are to be learned from VA's experience with
large scale adverse event disclosures?
Mr. Watson. Well, I think what we have observed from the VA
is not uncommon as some other Members of the Committee have
mentioned earlier.
We have learned that we need to improve the labeling of
these devices to make sure that people can use them properly.
And again, I will say that by doing so we can help people do a
better job of actually reprocessing these devices.
The communication that we would like to have in the June
8th and 9th workshop will also allow us to get other
perspectives, by the way that guidance that we put out is a
draft so we are asking for comments back on that. We are hoping
that we can get some more communication in that workshop from
all stakeholders we have, not only the VA, we have other
healthcare organizations arriving, we have accreditation
organizations like JCO, for example, the Commission is going to
be there, and we are also hoping that users and medical device
manufacturers will be there so that they can have a dialogue on
the actual ground-level problems that they are seeing. By doing
so, we can help those manufacturers come up with better device
designs.
Some of the device designs that are out there right now
don't facilitate reprocessing. They might have narrow lumens
that make it difficult to clear, they might have hinges, they
might have rough surfaces on the inner lumens that collect
debris.
So we are hoping that by having this dialogue we can lay
the ground work for future device designs to come out that will
help facilitate those folks in the hospitals to do a better
job.
The Chairman. Dr. Bell.
Dr. Bell. Unfortunately I think one of the most striking
things related to what we have heard about today is that it is
not unique to the VA system. It is emblematic of healthcare in
the United States. We are seeing lapses in basic practices
across the county and in Canada as well. This is something that
needs to be tackled systematically.
I think that the benefits of being able to work through
something like this include having an opportunity to deliver
better products to the users. We have been able to take our
long-standing guidelines, and this is nothing new in terms of
science, but those guidelines are now packaged in handy tools
for CMS surveyors to use when they actually look at facilities.
The same tools are being used by the Joint Commission.
It is striking to me that a facility that was shut down in
Nevada a couple years ago was shut down 3 months after it
passed with flying colors from a local inspection. The problem
there is that they are inspecting many of the wrong things.
They are looking at fire extinguishers and hallway widths, all
of which are fine, but they are not looking at some of the
critical issues about infection safety and other safe medical
practices.
Being able to translate our guidelines into useful tools to
put into the hands of the surveyors is one way that we are
making use of these unfortunate examples.
Being able to build the guidelines into CMS payment
policies so that at a broader level we are able to enforce
adoption of these guidelines with fiscal authorities, that is a
second way that we are seeing some benefit here.
With regard to the notification issue we were asked for
input from the VA and we provided that. Related to that we also
were able to do some consumer outreach and find out what people
really wanted to hear about and how they wanted to hear it.
That is something that we have published on now.
And then lastly we convened an ethics group to understand
all of the ramifications of notification, including when is the
notification something that could be harmful and how do you get
around that harm to ensure transparency?
The Chairman. Thank you. Mr. Filner.
Mr. Filner. Thank you for your testimony today. For the
record, I would like to note that Secretary Petzel and his
staff are all in the room. Thank you for staying. I was always
frustrated when the VA folks would testify and then walk out
and never listen to the other testimony. So thank you for being
here and listening to the other witnesses.
I assume you were here for the earlier testimony. My senses
was, and tell me if I am right or wrong, but the issues that we
are dealing with here today are not primarily those of either
the science or the procedures. We have the procedures, and Dr.
Petzel explained nine levels of oversight to make sure that
when mistakes occur we get those new policies in place. That is
not my sense of where the problem is.
My sense is still in the accountability and the way we
communicate. We are a public institution, and we have to handle
things in a different way than in the private sector and how we
notify not only the patients, but the public at large and the
stakeholders.
I don't know what your sense is that because in all these
cases that we heard, and I have been to most of the hospitals,
the problem was whether the employees were implementing good
policies or not or whether they were covering up those
incidents. Those became the problems. I think the public
understands that mistakes are going to be made, they just want
to have honesty about it. What is the risk, what do I do to
treat it, and let us get on with it. Not that mistakes won't
get made.
I don't know what your sense is, if you want to comment on
that. I am harping on the accountability because I think that
is where the problem is.
Dr. Bell. Well, if I may, I will say that what you are
describing is an important transformation to a culture of
safety. This is something that is important across the
healthcare system in this country.
There was a time when infection prevention was presumed to
be the job of an infection control nurse and that that
individual would take care of. In fact it is everybody's job.
Anybody who has any contact with a patient is responsible to
ensure that individual's safety. And having that be understood
throughout a healthcare system is one of the major goals and
challenges that we face right now.
When you talk about accountability hand in hand with
transparency we want a system where any individual can stop a
process cold and say, no, what I just saw was a mistake, we
have to stop that. We have seen that work.
Shortly after the public was notified in the newspaper of
syringe reuse mistakes there was a Secretary in a clinician's
office who watched the physician start to reuse a syringe and
say I just read that that is wrong. We have to stop doing that,
and by the way we should notify the health department.
So that kind of culture of accountability and safety is
something that I think needs to increase throughout our
healthcare system.
Mr. Watson. I would like to add to that if I could. So I
would like to echo Dr. Bell's comments, and I would like to say
that it is not only an issue of not being able to communicate
properly or lack of leadership, it is also unfortunately a lack
of knowledge and understanding of the process and the
procedures. There is some science, the science is well known,
but not to everybody.
I think there is some element of understanding the
importance of what needs to be done as well. For our part, what
we have been trying to do is help propagate that message of the
importance of doing the right thing all the time and ensuring
that the folks that are going to be responsible for cleaning
these devices actually have something less complex that they
can actually clean.
We heard from Dr. Petzel that they were reducing the number
of devices in their hospital, that all the people would have to
learn how to reprocess. That is a very important step. One of
the things that we talk about is reducing the complexity of the
reprocessing system.
I think it is more than just goes to leadership, it
actually goes to fixing the system, making sure that we can all
communicate properly and that we all take our responsibility
for the links that we put in the chain to correct the system,
and that is what we are trying to do right now. And I believe
from what I have heard that it is also what VA and CDC have
done. We have had communication about various topics, not just
this issue, where we are trying to close the loop on that.
Mr. Filner. Thank you very much. Thank you, Mr. Chairman.
The Chairman. Mr. Bilirakis.
Mr. Bilirakis. I have no questions, they were already
asked.
The Chairman. Ms. Buerkle.
Ms. Buerkle. Thank you, Mr. Chairman. Thank you both for
being here today. Just a question to Dr. Bell.
What guidance do you think the CDC could provide for risk
management?
Dr. Bell. By risk management do you mean in terms of
preventing these problems?
Ms. Buerkle. Yes.
Dr. Bell. We have actually just produced a consolidated
document that takes all of the existing guidelines, which
admittedly are substantial, and condenses them down for the use
of ambulatory care settings where many of these errors are
occurring. That is now up on the Web site and is a nice 12-page
synopsis of the minimum expected standards for safe practices.
I think we are recognizing increasingly that having a large
scientific document sitting on a Web site is not good enough
and that we need to produce easy, simple, straight forward
things.
We are also partnering with organizations like the Safe
Injection Practices Coalition to produce useful graphic
materials and tri-fold pamphlets and so on, posters, that
individuals can use at the site of care as reminders for care
providers.
So I think there are many ways that we can reduce risk by
pushing the information. As Mr. Watson said, it is not a lack
of information, it is that the people doing the practices don't
always have it.
Ms. Buerkle. And just if either one of you know the answer
to this question.
What percentage of instruments that are used on an ordinary
basis in a hospital are disposable versus reusable?
Mr. Watson. I don't have that information. We have try to
go back and find that out though if you would like.
[The FDA subsequently provided the following information:]
According to our database, the Food and Drug Administration
(FDA or the Agency) has cleared approximately 232 devices that
are intended to be reprocessed since 1980. These are various
devices such as endoscopes, (e.g., bronchoscopes,
duodenoscopes, and colonoscopes), endoscope accessories,
forceps, arthroscopic shavers, etc. However, this number cannot
be considered comprehensive because there are limitations to
the information. For example, our databases have not always had
the ability to track devices intended to be reprocessed. Also,
this number could include devices that have been modified and
provided to FDA under a new submission. Therefore, this number
would include duplicates. Another challenge is that not all
devices require a submission to FDA. For example, most of the
reusable manual surgical instruments are Class I exempt and are
reusable. They do not need a submission to FDA to go to market.
Regarding disposable devices, the percentage in use in
hospitals depends on what one calls ``disposable.'' Some
devices are comprised of both reusable and disposable
components, making a calculation for the percentage in use
rather difficult. For example, scalpel handles are reusable,
but their blades are single use, disposable. Large bore biopsy
needles may be reusable but most narrow lumen needles are
single use, disposable. Endoscopes used during surgery are
reusable, but their connecting tubing--to deliver and drain
irrigation fluid, is disposable. There are perhaps a hundred,
if not more, 510(k) clearances for the reusable rigid
sterilization trays and containers which hold the reprocessed
manual surgical instruments. Most of the more recent
submissions have multiple models of trays in different sizes
and shapes, with different internal configurations to hold
specialized instruments in some cases.
Ms. Buerkle. That would be helpful.
And as a followup to that, of those that are reusable which
ones pose the most significant problems, and what are the ones?
Obviously not all of reusable instruments probably have the
same occurrence as with complication, so if there is any way to
find out which are the ones most responsible for these problems
that would be helpful as well.
Mr. Watson. Well, if I may, we are actually doing that
research to get that information, because one of the things we
want to do is be able to help manufacturers understand which of
their devices are most at risk. But we do know some of the
device design issues that play into that and I kind of
mentioned some of those earlier, narrow lumens, devices that
have rough surfaces on the inside that retain debris. If that
debris happens to dry out and they don't clean it properly and
it happens to dry it is very difficult to get out at a later
date and it might actually still be there further down the
line, devices that have attachments to them they collect
debris, and sometimes there are issues chemicals and material
compatibility also.
So we are actually studying device designs that we know are
problematic, and in fact we have partnered with the University
of Michigan, and they are doing a two-phase study for us. They
are actually looking at device designs that might cause
problems, and there will be some interesting information coming
back on that, and they are also looking at reprocessing
instructions, that is the next phase at very specific devices
looking at the reprocessing instructions to see if those
reprocessing instructions make sense and they can actually be
followed.
So we will hopefully have more information on that at a
later date, but we are looking at that right now.
Ms. Buerkle. Very good. Thank you very much. I yield back
my time.
The Chairman. Thank you very much. Any other further
questions? If not we thank you. We do have some followup
questions that will be submitted for the record.
All Members will have 5 legislative days to revise and
extend their remarks and submit questions for the record if
desired.
Thank you very much for being here, we thank VA for being
here today, and we have votes coming up in just a moment, so if
there is no further business this Committee meeting is
adjourned.
[Whereupon, at 1:04 p.m., the Committee was adjourned.]
A P P E N D I X
----------
Prepared Statement of Hon. Jeff Miller,
Chairman, Committee on Veterans' Affairs
The Committee will come to order.
Good morning and welcome to today's Full Committee hearing ``Sacred
Obligation: Restoring Veteran Trust and Patient Safety.''
Before we begin, I would like to ask unanimous consent for our
colleagues Lacy Clay from Missouri, Jerry Costello from Illinois,
Blaine Luetkemeyer from Missouri, Ros-Lehtinen from Florida, John
Shimkus from Illinois, Mike Turner from Ohio, and Frederica Wilson from
Florida to sit at the dais and participate in today's proceedings.
Hearing no objection, so ordered. Thank you all for joining us.
We, as a Nation, put our trust in the men and women who serve in
our Armed Forces to protect us and our freedoms. And, in return, our
servicemembers put their trust in us to provide them with the highest
quality healthcare.
However, incident after incident of serious patient safety
violations in VA medical facilities across the Nation in locations such
as Dayton, St. Louis, and Miami, resulting in thousands of veterans
across the country receiving notification of their potential risk for
infectious diseases like HIV and hepatitis, shatters the very trust
veterans should have in us.
After each of these incidents, the VA assured Congress, and the
country, that it was aggressively addressing patient safety issues and
never again would a veteran's trust be compromised by lapses in quality
care at a VA medical facility. And yet, each patient safety incident
has seemingly led the way for the next ``lessons learned'' and the
unacceptable and inexcusable revelation that the patient safety
culture in VA is fractured and accountability and leadership at the helm
are lacking.
The time for talk is over. VA must confront these issues head on,
deepen the obligation to care for the veterans affected by these
incidents, and make the necessary changes within the VA healthcare
system to prevent any future incidents that would put veteran patients
at risk.
To that end, at this hearing today we will address in depth the
efficacy of VA's patient safety policies and VA leadership's ability to
provide adequate oversight of its medical facilities.
Further, we will explore the development of proactive strategies
for addressing the issues that underlie the lapses we've seen in
patient safety including the need for: (1) improvements in reprocessing
of reusable medical equipment; (2) systematic ways for VA to limit the
activities of suspect practitioners; and (3) better and more consistent
risk management and notification processes for veteran patients when
incidents do occur.
It is unconscionable that any one of our veterans should ever be
exposed to infectious diseases because of the care they receive at a VA
medical facility.
I want to assure all of you that this Committee will be tireless in
its oversight to ensure that VA lives up to its creed to provide only
the very best and the very safest care anywhere.
I thank you all for joining us for this important and ongoing
discussion.
Before I yield to the Ranking Member, I'd like to remind witnesses
that testimony is due no later than 48 hours in advance of a Committee
or Subcommittee hearing. I am told the DAMA Subcommittee did not
receive VA testimony until late yesterday in preparation for today's
8:00 a.m. hearing. That is inexcusable.
In addition, I and other Committee Members submitted a series of
questions 7 weeks ago in relation to VA's FY 2012 budget request, yet
no responses have been received. I would ask those here from VA today
to please convey my disappointment about this performance and my
expectation that things will improve in the very near future. I yield
to the Ranking Member.
Prepared Statement of Hon. Bob Filner,
Ranking Democratic Member, Full Committee on Veterans' Affairs
Good morning. I would like to thank everyone for attending this
important hearing today.
The purpose of today's hearing is to gauge VA's response to several
recent incidents that profoundly affect veterans due to the failure of
some to follow policies, procedures and protocols that have been put in
place to prevent such occurrences.
We are also going to look at what measures have actually been
implemented to ensure that these types of lapses do not happen again.
Mr. Chairman, I have to say, and I think you would certainly agree
that we have been here before! Please indulge me in my brief chronology
of events.
In December 2008, we were notified of improper reprocessing of
endoscopes which put thousands of veterans in Murfreesboro, Mountain
Home Tennessee, and Miami, Florida, at possible risk of hepatitis and
HIV.
In February 2009, another 1,000 veterans in Augusta, Georgia,
received notifications that they were at risk for hepatitis and HIV
because of improper processing of ear, nose, and throat endoscopes.
In July 2010, this Committee held a field hearing in St. Louis,
Missouri, a hearing you attended Mr. Chairman, along with many of our
colleagues today, after we had learned of lapses in protocol with the
cleaning of dental equipment which put at risk 1,800 veterans.
The most recent notification, the egregious incidents at Dayton,
Ohio, affected over 500 veterans and involved a whole host of problems.
The findings beg the questions of proper accountability, effective
oversight and enforcement of clear policies and procedures.
Policies and procedures that are sometimes not followed--or worse--
get completely ignored. I would like to know, where is the strong,
proper leadership and effective communication that is critical when you
are entrusted with the care and well being of our Nation's veterans.
Let me point to another big concern as a result of these incidents
and that is the absolute need for effective communication within the
management ranks and below. I am sure the Secretary of Veterans'
Affairs would agree with me on this.
Clearly, VA has had issues with ensuring the sterility of reusable
medical equipment in the past and now, other patient safety issues have
come to light, as evidenced in the continuing problem of veterans being
vulnerable to infectious diseases due to the problematic, yet
prevalent, issue of lack of following sound agency guidelines and
policies concerning patient safety.
In addition to what has been looked at over the past 3 years, I am
strongly dedicated to the need for ensuring that we do everything
possible so that this does not happen again.
And, as we are all aware, VA has a higher commitment and a moral
compact to provide the utmost level of care possible. It is this
Committee's responsibility to ensure that VA has the proper resources
to fulfill that mission.
I would like to acknowledge and want to recognize the VA's
excellent healthcare services and the dedication of the vast majority
of their staff.
I would also like to acknowledge the work they have done to
mitigate the issues at hand. We know it has not been easy.
I look forward to hearing today's testimony.
Prepared Statement of Hon. John Barrow
Thank you Chairman Miller and Ranking Member Filner for holding
this hearing on restoring the trust our veterans have in VA's services.
We can't keep those promises if veterans don't trust that VA's
facilities and services are safe.
This is an issue that hits close to home for the veterans in my
district. The Charlie Norwood VA Medical Center in Augusta, GA has been
found out of compliance of VA's sterilization process in 2008, 2009,
and 2010. They have had to warn veterans that they may have been
infected with diseases because of unclean ear, nose, and throat
utensils. As recently as November, the Charlie Norwood VA Medical
Center had to halt all elective procedures because they were not
following the proper sterilization procedure.
Just 2 weeks ago, The American Legion inspected the Charlie Norwood
VA Medical Center in Augusta, GA. The Legion found what we already
know: like many VA facilities throughout the Nation, the Charlie
Norwood VA Medical Center has been under the supervision of an ``Acting
Director'' for several months. Without a permanent director a VA
hospital does not have the long term leadership to initiate the reforms
to ensure high quality, safe, and reliable care. And until veterans can
trust that the care they receive is high quality, safe, and reliable we
aren't keeping the most basic promise to them.
I look forward to the testimony of today's witnesses, and I hope we
can identify specific solutions to specific problems, like having too
many ``Acting Supervisors'' in positions that require long term
accountability.
Prepared Statement of Michael R. Turner,
a Representative in Congress from the State of Ohio
Chairman Miller, Ranking Member Filner, I would like to thank you
for your leadership on this issue. Your responsiveness to my request to
visit the facility in Dayton and decisiveness in holding this vitally
important hearing are a testament to your dedication to our Nation's
veterans.
Along with the many other tragic issues addressed in today's
hearing, the events that transpired at the Dayton VA Dental Clinic are
extremely disconcerting because they further illustrate systemic
problems in the medical system that provides care for our Nation's
veterans. The dentist in question violated infection control standards
for nearly two decades. During a significant period of this time he did
so with the knowledge of many fellow employees and some supervisors. In
failing to report these problems the clinic needlessly put thousands of
veteran lives at risk. Several patients have tested positive with
hepatitis, and I, along with a panel of healthcare professionals,
believe that many more are at risk and should be notified and tested.
Last week, I participated in a field hearing with Senator Brown
under the jurisdiction of the Senate Veterans Affairs Committee on this
same issue. As I discussed there, it is important for the community to
become involved in this process because they were the victims and their
input will be vital in reestablishing the community's trust. In an
effort to ensure the safety of all the identified victims and
potentially unidentified victims, the Greater Dayton Area Hospital
Association (GDAHA) has reached out to the VA to help in this process.
GDAHA is empaneled by a group of local physicians and has the community
interests in mind.
During the course of their investigation GDAHA recently published
an interim report in which they disagreed with the VA's decision to
limit the look-back period to 1992. Instead the group concluded that
the VA should notify and test all patients seen by the DIQ, to include
the next-of-kin of deceased patients. Their independent conclusions
were made with a view towards the best interest of the patients and
community and were free from the influence of VA leadership. I have
submitted this information to Secretary Shinseki and requested that he
adhere to their recommendations. I hope that he will choose to enact
these recommendations in order to protect those that may have been
exposed and help restore the community's faith in the VA.
While I appreciate the investigations that have been conducted by
the VA, I would like to point out that internal constraints placed on
the OIG investigative team bring the findings of their investigation
into question. I am concerned that the scope of the OIG investigation
was limited by an inability to interview key witnesses. As the report
itself states, the OIG investigative body was unable to interview
several key witnesses simply due to their retirement. These witnesses
included the original SOARS complainants, a fellow dentist and the
facility's Chief of Staff. Their exclusion from the evidence gathering
process devalues the OIG's findings significantly and raises a very
serious question.
Simply stated: What kind of system does the VA have in place where
the leadership can evade investigative processes simply by opting into
retirement? The ultimate consequence of this model is that veterans and
their families carry the scars and the taxpayers carry the debt while
the responsible individuals walk away into comfortable retirement
without accounting for their negligence.
This system is broke and it needs to be fixed. The VA and Congress
share a responsibility to provide the greatest amount of protection for
all the potentially affected veterans and their families. In light of
this, I concur with GDAHA's recommendations that the VA should notify
and test all patients seen by the DIQ, to include the next-of-kin of
deceased patients. I also take issue with the underlying rationale to
limit the scope of the testing.
In moving forward, I hope that the VA will make a greater effort to
work with Congress and the community to ensure that all potentially
affected victims are notified and tested. Further, I would like the VA
to work in concert with regional stakeholders to identify the
underlying problems that allowed this tragedy to happen, and devise a
solution that will prevent it from ever happening again. In order to
accomplish this, the VA should conduct an open and transparent process
that includes information sharing with GDAHA and the community.
After all, our country has thousands of young men and women that
are making as great of a sacrifice as any generation before them. We
need to make sure that they have the peace of mind to know that if they
need help when they are done, there will be a fully functioning and
competent VA here to give them that help when they need it. Further, we
need to ensure that a system is in place that holds the leadership
accountable for their actions and does not allow them to simply walk
away at the first sign of trouble. This leadership from the rear
mentality has no place in the Department of Veterans Affairs and is
particularly shameful in an environment built to care for those
veterans that kept our country safe and free.
Prepared Statement of Hon. Jerry F. Costello,
a Representative in Congress from the State of Illinois
I would like to thank Chairman Miller for holding today's hearing
to examine repeated lapses in patient safety at U.S. Department of
Veterans Affairs (VA) facilities. I look forward to hearing about the
underlying issues causing these failures and what changes were
implemented to ensure they do not happen again.
As I have said on numerous occasions, the dedicated efforts of VA
employees and their strong commitment to quality care are an example of
our country's sincere promise to look after the brave men and women who
have protected our Nation for over two centuries. Their compassion and
expertise are an asset to the VA and I encourage the employees to
remain diligent about communicating discrepancies in protocols.
Many of my constituents receive medical care from John Cochran
Veterans Medical Center (VAMC) in St. Louis, Missouri, which was the
subject of a July 2010 field hearing to examine lapses in cleaning
reusable dental equipment. This occurrence was disturbing by itself--
putting the health of 1,812 veterans at risk--but to know that it is
one of many instances in which the VA has failed to perform the basic
duties of its daily operations is truly shocking. For example, a March
7, 2011, VA Office of Inspector General (VA OIG) report on a site visit
to John Cochran VAMC noted numerous inconsistencies remained after the
July hearing, ranging from the unavailability of manufacturer's
instructions on how to clean reusable medical equipment (RME),
insufficient staff training, and inadequate oversight.
Several other reports and investigations by the VA OIG and the
General Accountability Office (GAO) have also identified continued
breakdowns in management practices for VA and facility leadership.
Despite the fact that both the VA OIG and GAO indicate that policies
and directives are in place, we are holding another hearing regarding
repeated oversight and compliance failures that put patient safety in
jeopardy.
These occurrences must stop and I implore the VA to work with
Congress to implement the proper training and oversight necessary to
limit these occurrences in the future, as we have been promised several
times would happen by VA officials.
Patient safety remains our top priority and our veterans deserve
the very best care available. Congress has a sacred obligation to
ensure the VA has the resources necessary to fulfill this promise.
I look forward to today's testimony.
Prepared Statement of Hon. Robert A. Petzel, M.D.,
Under Secretary for Health, Veterans Health Administration,
U.S. Department of Veterans Affairs
Chairman Miller, Ranking Member Filner, and other Members of the
Committee. Thank you for the opportunity to discuss the Department of
Veterans Affairs' (VA) patient safety policies and strategies that
build trust and ensure the safe and compassionate care of our veterans.
I am accompanied today by Robert Jesse, M.D., Ph.D., Principal Deputy
Under Secretary for Health; William Schoenhard, Deputy Under Secretary
for Health Operations and Management, George Arana, M.D., Acting
Assistant Deputy Under Secretary for Health for Clinical Operations,
and Andrea Buck, M.D., Acting Chief Medical Officer.
First and foremost, I would like to apologize on behalf of the
Department to those veterans who have been affected by a lapse in
patient safety practices at any of our facilities. The greatest
commitment of every VA employee is the well-being of our veterans. In
the Veterans Health Administration (VHA), from the housekeeper, who
ensures each patient's room is clean, to the Under Secretary for
Health, we are united in a common mission to protect and provide
quality healthcare for those who served to defend this Nation.
When a lapse in patient safety practices occurs, it is VA's
fundamental belief that we must be open and transparent with regard to
our mistakes and any necessary actions that may result. This can result
in disclosing medical events even when not a common practice by others
in the medical community. For example, in 2010, The New England Journal
of Medicine published an article noting that large-scale adverse events
in medical settings are not uncommon; the article described in detail
VA's disclosure policies and concluded, ``The VHA policy represents a
valuable resource for all healthcare institutions.'' \1\ We carefully
consider the effects of any disclosure, but our practice is to provide
more information to our veterans in an abundance of caution, even if
the risk to their health is low.
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\1\ Denise M. Dudzinski, Philip C. Hebert, Mary Beth Foglia, and
Thomas H. Gallagher. ``The Disclosure Dilemma, Large Scale Adverse
Events.'' The New England Journal of Medicine. Vol. 363, no. 10.
September 2, 2010. P. 978-986, p. 984.
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We are particularly concerned about any event where veterans are
put at risk because we believe we provide excellent care, and we have
the data to support that belief. Despite caring for patients that are,
on average, sicker, older, and less affluent than the general
population, VA's performance overall exceeds the best U.S healthcare
systems. Our data collection and publication program is unprecedented
in U.S. healthcare, as we report more data about our programs online
than anyone else. As the Wall Street Journal observed in March 2011,
``This usually comprehensive sort of consumer information on medical
outcomes remains largely hidden from the tens of millions of Americans
outside the VA system.'' \2\ Professional publications and the
mainstream media have recognized and lauded our accomplishments in
providing the best integrated healthcare in the country. Recently, The
New England Journal of Medicine published an article praising our
programs to reduce healthcare-associated infections by methicillin-
resistant Staphylococcus aureus (MRSA), a bacteria known to be
resistant to most antibiotics.\3\ In the words of a New York Times
editorial about this study, ``If other hospitals could replicate the
effort, thousands of patients might be saved from needless infections
acquired after they entered the hospital.'' \4\
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\2\ Thomas M. Burton. ``Data Spur Changes in VA Care.'' The Wall
Street Journal. March 29, 2011. Available online: http://
online.wsj.com/article/SB10001424052748703512404576208812390
820304.html.
\3\ Rajiv Jain, et al. ``Veterans Affairs Initiative to Prevent
Methicillin-Resistant Staphylococcus aureus Infections.'' The New
England Journal of Medicine. Vol. 364, no. 15. April 14, 2011. P. 1419-
1430.
\4\ The New York Times. ``Hospitals Shouldn't Make You Sicker.''
April 17, 2011. Available online: http://www.nytimes.com/2011/04/18/
opinion/18mon3.html.
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These accomplishments are significant, but they are not, and never
will be, enough. We owe it to our veterans and ourselves to continually
strive to be better. We must be the veteran-centric, results-driven and
forward-looking organization the Secretary has called us to be. This
means we will continually learn how to do our jobs more effectively,
more efficiently, and more compassionately.
My testimony today will provide an overview of our quality and
patient safety programs. It will then describe our practices for
standardized reprocessing of reusable medical equipment; our systematic
approach to limiting the activities of suspect practitioners through
rigorous credentialing and privileging, as well as peer review; and
risk management and notification processes for veterans.
VA Quality and Safety Programs
VA is committed to providing the safest and highest quality
healthcare for veterans. We have established a wide array of innovative
and comprehensive programs to measure, analyze, improve and report on
all aspects of healthcare quality and patient safety. We have published
an annual report on each facility's quality and safety performance
since 2008, and these reports are available online (http://www1.va.gov/
health/HospitalReportCard.asp). The 2010 report includes new metrics,
such as medical and surgical outcomes data, as well as a detailed
analysis of VA's safety reports. We have identified six domains in line
with the Institute of Medicine's recommendations for quality in
healthcare: effective, equitable, safe, timely, patient-centered, and
efficient. We have been an early adopter of performance measurement and
improvement because we at VA have a special responsibility to maintain
the trust of the veterans we serve and the public at large.
All eligible VA facilities and programs have been accredited by The
Joint Commission, and over 200 programs were accredited by the
Commission on Accreditation of Rehabilitation Facilities. The Joint
Commission's accreditation is nationally recognized as a symbol of
quality and is considered one of VA's major external quality reviews.
Joint Commission accreditation confers recognition that VA healthcare
organizations meet certain standards of quality and safety, as well as
compliance with healthcare quality standards of payors. The Commission
on Accreditation of Rehabilitation Facilities reviews VA programs
designed to provide specialized treatment and quality rehabilitation to
veterans with disabilities. Various specialty programs are also often
reviewed and accredited by boards with expertise in those disciplines.
We estimate that more than 4,100 site visits occur at VA healthcare
facilities each year to support approximately 2,000 total accreditation
reviews and inspections.
According to the Healthcare Effectiveness Data and Information Set
(HEDIS), VA facilities provided high quality outpatient medical care
and compared favorably with the top performing health plans in the
Nation. When looking at disease-specific healthcare within inpatient
settings, VA also compares favorably with the best hospitals in the
Nation on core indicators of quality that are published on Medicare's
Hospital Compare Quality of Care Web site. The rates of hospital-
acquired infections at VA were generally low when compared with
national averages according to the Centers for Disease Control and
Prevention. Many VA facilities report rates that match or are lower
than the top 10 percent of reporting hospitals in the country (lower
infection rates are better). High quality outpatient care was available
to veterans regardless of where they lived. Women veterans receive
gender-specific care that substantially exceeds care available in non-
VA healthcare systems.
There are several programs that have proven instrumental to VA's
success in overseeing quality care. First, VA's Surgical Quality
Improvement Program (VASQIP) monitors surgical procedures and tracks
risk-adjusted surgical outcomes, including complications (morbidity)
and mortality rates. VASQIP analyzes aggregate patient data from
surgical outcomes of 124 VA facility surgical programs using
mathematical models to predict an individual patient's expected outcome
based on the patient's pre-operative characteristics and the complexity
of the surgical procedure being performed. This calculated expected
outcome is then compared to an observed outcome on a regular basis.
Facilities with an observed adverse outcome that significantly exceeds
expected outcomes undergo a quality improvement assessment to identify
specific issues that require resolution to enhance patient safety. This
kind of monitoring has resulted in reductions in patient morbidity and
mortality across the organization. VASQIP was developed more than 15
years ago, and the American College of Surgeons now offers a similar
program to private sector hospitals.
Another effort is VA's National Center for Patient Safety (NCPS),
which was established more than 10 years ago to improve the quality and
safety of care we provide. One key process that NCPS uses when an
adverse event or a ``close call'' happens is a root cause analysis
(RCA) to identify the basic or contributing causal factors. This is an
interdisciplinary review process that focuses primarily on systems and
processes, rather than individuals, to determine what actually or
almost went wrong. These investigations can identify changes that
should be made to either redesign or develop our practices and reduce
the risk of a similar event in the future. Approximately 40 percent of
RCAs are done on events that produced little or no harm to patients.
This is a testament to VA's developed culture of safety, as it reflects
the willingness of staff to identify close calls for review and
analysis. The five most common subjects for an RCA include falls;
delays in treatment, diagnosis, or inpatient surgery; ``high alert''
adverse drug events; unexpected deaths (other than suicide); and
outpatient suicides. Both The Joint Commission and VA require an RCA to
be completed within 45 days; as such, we track the timeliness of these
investigations, and we have shown continued improvement over the last
several years in completing these in a timely manner.
Finally, VA has recently begun publishing detailed quality and
safety data online to inform veterans and the public of the care we
provide. These efforts also improve our internal accountability
structure. ASPIRE is a Web-based dashboard that documents quality and
safety goals for all VA hospitals and reports on how individual
hospitals are meeting these standards. The standards identified by
ASPIRE are the gold standard and should be the target of every
healthcare organization; for example, we have targeted zero MRSA
infections in all of our facilities. We will not necessarily meet these
objectives, but they should always be our goal. The Linking Knowledge
and Systems (LinKS) dataset is another dashboard that summarizes
outcomes in areas such as acute care, safety, intensive care, and other
measures. LinKS reports quarterly risk adjusted as well as unadjusted
data that shows how well each VA hospital is performing and areas in
which each facility can improve. Much of the data in the LINKS and
ASPIRE dashboards are simply not available in other healthcare systems,
which limits VA's ability to compare itself against other healthcare
systems.
Nevertheless, VA has been identified as a leader in the field, and
we are setting the bar for other systems to meet. Perhaps most
importantly, we are using these quality and safety datasets to inform
the performance reviews of senior leadership. A key element of the
performance plan for every Veterans Integrated Service Network (VISN)
Director and VA Medical Center (VAMC) Director is based on objective
performance in healthcare quality and safety, as measured by
independent sources of information pulled from our electronic health
record system. VA has also contracted for an external peer review
program, which selects a statistically significant random sample of
cases for each facility and assesses the care we provided. This assists
VA with validating our internal peer review process and helps ensure we
are providing the highest quality of care to our veterans.
Standardized Reprocessing of Reusable Medical Equipment
VA has made significant progress in standardizing sterile
processing techniques across the Department. We have worked with the
International Association of Healthcare Central Service Material
Management, an internationally recognized organization in sterile
processing, to provide supply, processing and distribution training. We
have also obtained a national contract to ensure all facilities are
supplied with up-to-date manufacturers' instructions for sterile
processing. New standard operating procedures for reprocessing are
currently in place. Beyond standardizing processes, VA seeks to set the
standard for effective and safe sterile processing techniques
nationwide. We have been soliciting proposals from the private sector
to automate sterile processing techniques to reduce the opportunities
for human error, and VA is internally pursuing innovations to improve
the safety, efficiency, and effectiveness of sterile processing.
Between January 1 and September 30, 2010, VA's Office of Inspector
General (OIG) Combined Assessment Program reviewed 45 VA facilities to
evaluate reusable medical equipment practices (RME) to determine if
facilities complied with VA standards for RME sterilization and high
level disinfection, provided documentation for annual training, and
assessed and documented annual competencies for employees who perform
RME reprocessing activities. OIG identified six areas where compliance
with RME requirements needs to improve. We appreciate their assessment
and their recommendations. We have concurred with their
recommendations, and we have either already completed these
improvements or we will do so within the next 6 months. Specifically,
the OIG recommended that VA senior managers (at the national, network,
and local levels) ensure that:
Standard operating procedures (SOPs) are current,
consistent with manufacturers' instructions, and located within the
reprocessing areas;
Employees consistently follow SOPs, supervisors monitor
compliance, and annual training and competency assessments are
completed and documented;
Flash sterilization is used only in emergent situations,
supervisors monitor compliance, and managers assess and document annual
competencies for employees who perform flash sterilization;
Appropriate personal protective equipment is donned
before entering and is worn in decontamination areas;
Ventilation systems are inspected and filters are changed
quarterly in all reprocessing areas and that temperature and humidity
are monitored and maintained within acceptable ranges in sterile
storage areas; and
Processes for consistent internal oversight of RME
activities are established to ensure senior management involvement.
In response to these recommendations, VA has modified inspection
processes at the network and facility level to ensure that employees
consistently follow SOPs and that training and competency assessments
are complete and documented. Staff from VA's Sterile Processing
Departments (SPDs) will perform site visits to provide additional
oversight to ensure that annual training and competency assessments are
complete as well. We developed and deployed a standardized template as
of February 14, 2011, that requires facilities to conduct six
inspections of SPD per year, and for VISN staff to conduct three
unannounced inspections each year. We will track and review the results
of these inspections nationally to refine our oversight methods. VA has
developed a national action plan to specifically address RME concerns
throughout its entire healthcare system. When VA Central Office learns
of an adverse event, we immediately activate a fact finding team of
appropriate subject matter experts to assess the event for veteran
risk. Depending on this team's determinations, VA may convene a
Clinical Review Board (CRB) to determine if disclosure to patients
should occur. We have also realigned our organization to create a
national SPD office that will provide guidance and oversight for our
experts in the field.
We believe veterans should be encouraged by the results of the
OIG's inspection. While the report identifies areas for improvement, it
also commends VA facilities for recognizing the importance of
maintaining consistent RME practices to ensure patient safety. VA's
policy is to cooperate with all reviews and investigations, from the
OIG and others, that have been designed to improve service and develop
better practices for healthcare. Our facilities have been increasingly
vigilant in monitoring, self-identifying, and investigating any
inconsistencies in procedures for cleaning RME, and our facilities are
conducting frequent and repeated reviews of their patient care areas to
ensure that procedures are clear and followed.
The Government Accountability Office (GAO) has also reviewed
selected VA facilities to assess the purchasing, tracking, and
reprocessing requirements for RME. GAO specifically looked at relevant
VA policies, as well as two purchasing, two tracking, and two
reprocessing requirements. These requirements were instituted following
patient safety incidents at the Palo Alto VAMC, the Miami VAMC, and the
Augusta and Murfreesboro VAMCs, respectively. GAO did not identify any
inadequacies in the purchasing requirements they selected for review in
the context of patient safety. In the area of tracking requirements,
GAO found VA has a limited ability to identify equipment on which there
are alerts or recalls and maintaining inventory, and that it also
experiences challenges developing required training in this area. For
reprocessing requirements, GAO found VA did not adequately specify the
types of RME that require device-specific training and that there is
conflicting guidance on the development of RME reprocessing training.
We greatly appreciate the work of the GAO in helping VA ensure our
programs are providing the quality of care our veterans deserve. We
have already begun instituting changes to address these concerns and
are ahead of the timeline we outlined for GAO. We are analyzing
information on non-compliance by specific VA medical centers and are
overseeing the development of corrective action plans. We are also
developing a systematic approach to analyzing information to identify
areas of non-compliance across the Nation, with particular focus on
those that occur frequently, pose high risks to veterans' safety, or
that have gone unaddressed. VA has drafted a new handbook that will
replace all existing sterile processing policies; this handbook will be
reviewed by experts from the field before publication to ensure its
requirements are consistent with best practices and capable of
implementation. To reduce the variation in equipment and accompanying
processes, VA has established national product specifications and
criteria for selecting standardized endoscopic equipment. Similarly, an
Integrated Product Team for Endoscopes has been charged with developing
recommendations for gastrointestinal (GI) endoscopic equipment. As part
of our ongoing effort to standardize the reprocessing of RME, we have
secured a national contract that supplies up-to-date manufacturers'
instructions to all VA facilities. These efforts will enhance patient
safety and quality, realize economic value, and reduce variability for
set up and reprocessing this equipment.
In addition, VA is partnering with local communities to provide
state-of-the-art training to those responsible for providing oversight
of VA's SPD. For example, in Phoenix, Arizona, VA has entered into a
first-of-its-kind agreement with a local technical college to provide
VISN SPD boards with a laboratory environment for hands-on training in
the reprocessing of RME. The first of these courses will begin in June.
By training the trainers and those responsible for oversight within the
Department, as well as providing support to community training efforts,
VA is setting the standard for excellence in the reprocessing of RME
nationwide.
Credentialing, Privileging, and Peer Review
Credentialing, privileging, and peer review are essential
components of our quality and safety program as they assess who is
competent to perform what types of procedures and how well they
perform. Credentialing refers to the systematic process of screening
and evaluating qualifications and other credentials, including
licensure, required education, relevant training and experience,
current competence and health status. Clinical privileging is a process
by which a practitioner, licensed for independent practice, is
permitted by law and the facility to practice independently, to provide
specified medical or other patient care services within the scope of
the individual's license, based on the individual's clinical competence
as determined by peer references, professional experience, health
status, education, training, and licensure. Privileging is both
facility- and provider-specific.
All VA healthcare providers who are permitted by law and the
facility to provide patient care independently must be credentialed and
privileged to do so. VetPro is VA's electronic credentialing system and
must be used for credentialing of all providers who are granted
clinical privileges or are credentialed for other reasons. This system
helps reduce the chance for human error and improves the care we
deliver at VA. All candidates must submit an application to VetPro
providing information regarding malpractice, adverse actions against
licensure, privileges, hospital membership, research, and other
factors. We do not allow an offer of employment to be made to providers
until the credentialing process is complete. This process entails
screening the candidate through the appropriate State Licensing Board,
the Federation of State Medical Boards, and the National Practitioner
Data Base (NPDB). The NPDB is a secondary flagging system intended to
support a comprehensive review of healthcare practitioners'
professional credentials by identifying any malpractice payments or
adverse actions against clinical privileges. NPDB screening is required
before an applicant's appointment; VA then monitors appointed
practitioners through the NPDB's continuous query program for as long
as they maintain an appointment at a VA medical facility. The
information we receive from NPDB offers further insight into the
provider's history as a clinician and is considered with other relevant
data in evaluating a practitioner's credentials. VA oversees this
program at the national, network and facility level to ensure
compliance.
Applicants for VA positions are required to respond to questions
concerning clinical privileges at VA and non-VA facilities. Privileges
are valid for a period not to exceed 2 years. To approve privileges for
a provider, VA requires evidence of current licensure, relevant
training and experience, current competence, and information associated
with the person's health status as it relates to the individual's
ability to perform the requested clinical privileges. We also require
information related to malpractice allegations or judgments, loss of
medical staff membership, loss or reduction of clinical privileges, or
challenges to licensure. At the facility level, each service chief is
responsible for developing additional criteria consistent with the
needs of the patient population at the facility. We continue to monitor
privileges based upon quality and performance data on an ongoing basis,
and we provide numerous training opportunities to ensure that those
responsible for assessing and validating credentialing and privileging
standards have the resources they need to help ensure quality patient
care.
VA also maintains a robust peer review program to oversee quality
and accountability for care. Peer review is a process carried out by an
individual healthcare professional or a select committee of
professionals to evaluate the performance of other providers. When
conducted systematically and credibly, as is VA's process, peer review
can result in both immediate and long-term improvements in patient care
by revealing areas for improvement in the practice of one or more
providers, which contributes to organizational improvement and better
patient outcomes. Peer review is intended to be a comprehensive,
confidential and non-punitive process that contributes to overall
quality improvement efforts and to the improvement of care for
veterans.
Peer reviews are conducted by internal and external parties. For
internal reviews, it is VA policy that each VISN and healthcare
facility must establish and maintain a program of peer review for
quality management purposes relevant to the care provided. Our
facilities must comply with the requirements of all applicable
accrediting and oversight agencies that review VA healthcare
facilities, including The Joint Commission. We have established
criteria that indicate who can serve as a peer reviewer to ensure these
individuals provide competent and accurate information to other
providers. VHA Directive 2010-025 provides clear guidelines for which
clinical events require a peer review for quality management purposes.
As mentioned earlier, VA maintains an external peer review program to
gather and validate information related to outcomes and processes for
each of our medical facilities. This provides an important, independent
assessment of the care we offer and provides an additional source of
validation for our internal processes.
Risk Management and Notification Processes
VA has an ethical and legal obligation to disclose to patients
adverse events they experienced during the course of their care,
including when the adverse event may not be obvious or severe, or where
the harm may only manifest in the future. Disclosure of these events is
consistent with our core values of trust, respect, excellence,
commitment and compassion. Facility Directors are responsible for
ensuring that healthcare providers communicate these events to patients
or the patients' representative and to support staff members who are
involved. It is VA policy to notify our patients of their rights under
section 1151 of title 38 United States Code and the Federal Tort Claims
Act, including information about procedures available to request
compensation as well as where and how to obtain assistance in filing
claims.
One of my chief priorities is to ensure VA is a learning
organization, and I have emphasized the importance of this philosophy
to all of our healthcare employees. If an error or an adverse event
occurs, we must determine if this was the result of a lack of training,
or some deeper problem. I believe in holding our providers accountable,
but accountability can take many forms and needs to be evaluated on a
case-by-case basis. Sometimes disciplinary action is warranted, and in
a number of situations, we have taken these necessary steps by
convening Administrative Investigation Boards (AIB) to determine the
proper response which can and has included administrative action.
Recommendations from all AIBs are shared and discussed with VHA
leadership for awareness and as a learning opportunity to understand
how to deal with any potential future adverse event within their
facilities.
In terms of notifications, any events that may require large scale
patient disclosures must be documented and communicated to VA Central
Office. When we learn of a potential adverse event, we convene a fact
finding team of subject matter experts from a range of disciplines to
assess the situation. At the conclusion of the fact finding review, a
Clinical Review Board (CRB) may be convened. The CRB is made up of
appropriate representatives from a range of disciplines and include
experts on quality and safety, public health, ethics, operations and
management, patient care, and VHA leadership. The CRB considers factors
such as the population at risk, the potential severity of outcomes, the
probability of those outcomes, and other factors relevant to the
population at risk. VHA Directive 2008-002 provides specific guidance
regarding what adverse events warrant disclosure, when disclosure
should occur, and how adverse events should be communicated.
We are also keenly aware of the need to disclose in a manner that
does not exacerbate problems and unduly worry our veterans or their
families. We have convened a working group that is developing common
guidance and templates for disclosures, and we expect to have results
from this group this summer.
Conclusion
Our primary mission at VA is to serve our Nation's veterans. In
terms of healthcare, this means providing veteran-centered care that
focuses on improving the lives and well-being of our patients. VA is
more transparent and makes available to the public more information
about our entire system than any other healthcare provider in the
country. Our initiative in this area earned the Department the Annual
Leadership Award from the American College of Medical Quality. We
subject our facilities to greater scrutiny through both external
commissions and accreditation organizations as well as internal reviews
from the facility, network and national level, including from the
Office of the Inspector General and GAO. We welcome these assessments
because they provide us with learning opportunities that will produce
even better healthcare systems and outcomes. And we welcome
Congressional oversight, as we work together to serve our veterans.
At VA, our fundamental belief is that our healthcare system is
designed to serve veterans, and that to do so, veterans must be an
equal partner in their healthcare decisions. For this partnership to
work, we must make sure they have access to the data they need to make
an informed decision, and that they must trust us to provide them this
information. We understand that disclosures can raise concerns among
the public, but we believe that veterans will have greater confidence
in a system that errs on the side of providing more information to
them, even when their health risk is low.
Thank you for inviting me here to testify today to discuss our
efforts in these vital areas. My colleagues and I look forward to any
questions you may have, and we welcome this discussion.
Prepared Statement of John D. Daigh, Jr., M.D.,
Assistant Inspector General for Healthcare Inspections,
Office of Inspector General, U.S. Department of Veterans Affairs
Mr. Chairman and Members of the Committee, thank you for this
opportunity to testify on aspects of patient safety that are critical
to the delivery of quality medical care to veterans. My statement and
comments are based on reports by the Office of Inspector General (OIG).
While the subject of this hearing is on substantive performance
gaps where the Department of Veterans Affairs (VA) needs to improve, I
want to clearly state that from the body of work conducted by the OIG's
Office of Healthcare Inspections, it is clear that VA provides veterans
with high quality medical care that has the support of veterans and
employees as measured by satisfaction surveys and is rated with the
best healthcare plans in the country. That being said, VA has had
several high profile and highly publicized incidents that naturally
would shake the faith of those who receive care from VA. Some of the
incidents were the result of improper reprocessing of complex medical
equipment and others were the result of leadership failing to act when
presented information of serious breaches of infection control
protocols.
REUSABLE MEDICAL EQUIPMENT
The reprocessing of reusable medical equipment (RME) is categorized
based on the associated risk of and the level of cleaning required to
prevent infection. Devices that enter normally sterile tissue,
including joints and the vascular system, require sterilization to
eliminate all forms of microbial life. Other devices, including many
endoscopes, examine intact mucous membranes and do not ordinarily
penetrate sterile tissue. For these devices, which are often
constructed of materials and mechanisms that are unable to withstand
exposure to the high temperatures or chemicals required for
sterilization, high-level disinfection (HLD) is appropriate. HLD
eradicates all micro-organisms ``except for small numbers of bacterial
spores.'' \1\
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\1\ W.A. Rutala, D.J. Weber, and the Healthcare Infection Control
Practices Advisory Committee, Centers for Disease Control and
Prevention, Guideline for Disinfection and Sterilization in Healthcare
Facilities, 2008.
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OIG Reports on RME
Healthcare Inspection, Use and Reprocessing of Flexible Fiberoptic
Endoscopes at VA Medical Facilities (June 16, 2009) and Healthcare
Inspection. Follow-Up Colonoscope Reprocessing at VA Medical
Facilities, September 17, 2009)
In June 2009, we reported on difficulties in reprocessing
colonoscopes at the Miami, Florida, VA Medical Center (VAMC) and the
Murfreesboro, Tennessee, VAMC, which led to the notification of 2,531
veterans at Miami and 6,805 veterans at Murfreesboro that they were at
risk of developing the blood borne infections of hepatitis B, hepatitis
C, and HIV. The same report details defects in reprocessing ear-nose-
throat endoscopes that resulted in 1,069 Augusta, Georgia, veterans
being notified of their risk of contracting blood borne viral
illnesses.
The report includes the results from an unannounced inspection of
VA medical centers that found more than half did not have appropriate
standard operating procedures (SOPs) and documented evidence of
employee training for the colonoscopes in use at the medical center. In
a follow up inspection of 129 VA medical centers that reprocessed
colonoscopes, we found that all had the appropriate SOPs for
reprocessing colonoscopes and one did not have adequate documentation
of employee training to reprocess the scopes
Healthcare Inspections, Patient Safety Issues VA Caribbean Healthcare
System San Juan, Puerto Rico Report (March 16, 2010)
The OIG received allegations regarding quality of care and patient
safety related to the RME reprocessing at the VA Caribbean Healthcare
System (the system) in San Juan, Puerto Rico. The complainant provided
more than 137 pieces of evidence to support their allegations. In our
March 2010 report, we substantiated multiple allegations:
For approximately 2 years, endovaginal transducers at the
Mayaguez Outpatient Clinic were not submitted to high-level
disinfection as required after each patient procedure.
Leak testing was not performed on colonoscopes in the
Operating Room for at least 9 months, leak testing was not performed on
laryngoscopes in Radiotherapy and at the Ponce OPC for 9 months and 3
years respectively.
Pre-cleaning was improperly performed on the
laryngoscopes in Radiotherapy.
One of the laryngoscopes had a leak while it was in
service during this time.
The system inaccurately certified compliance with RME
reprocessing procedures and training on three occasions.
Senior system leadership and responsible managers were
aware of these issues but took no action to assess the risk to
patients.
As a result of our review, issue briefs (IB) on each area were
discussed on pre-Clinical Risk Assessment Advisory Board (CRAAB)
conference calls. Based on information provided by the system, the risk
to patients was determined to be negligible. An Administrative
Investigation Board (AIB) was completed after our visit to address
management responsiveness. We recommended that the Veteran Integrated
Service Network (VISN) Director follow up on all recommendations from
the AIB and take appropriate administrative action.
Healthcare Inspection, Alleged Endoscope Reprocessing Issues St. Louis
VA Medical Center St. Louis, Missouri (April 21, 2010)
This review was conducted to determine the validity of allegations
regarding ongoing issues in the Supply, Processing, and Distribution
(SPD) department related to endoscope reprocessing and communication at
the St. Louis VA Medical Center, St. Louis, Missouri.
We substantiated:
Endoscope reprocessing issues have been ongoing. We
reviewed documentation related to three contaminated gastrointestinal
(GI) endoscopes, which were identified prior to patient use. We also
reviewed documents notifying managers that damage and repairs to
endoscopes had increased. We requested the 2009 repair log and
associated costs from SPD and found that a majority of the scopes that
were damaged or needed repair belonged to the GI service.
Breakdowns in communication of adverse events and
outcomes existed. We found minimal documentation as well as
communication failures for two of the three adverse event reports (AER)
reviewed.
In addition, we conducted an unannounced inspection of the SPD
area. We identified several items related to reusable medical equipment
reprocessing and staff safety that needed improvement as required by
Veteran Health Administration (VHA) policies.
We recommended that the AER reporting process is clearly defined,
timely, and well-documented and that implemented action plans are
monitored for compliance to eliminate ongoing endoscope damage and
reprocessing issues. We also recommended that SPD meet VHA policy and
is monitored for compliance.
The VISN and Medical Center Directors agreed with the findings and
recommendations. We closed this report on February 17, 2011.
Healthcare Inspection, Reprocessing of Dental Instruments, John Cochran
Division of the St. Louis VA Medical Center, St. Louis, Missouri (March
7, 2011)
The purpose of this review was to determine the sequence of events
involving alleged improperly cleaned and sterilized dental RME; errors
in reprocessing or sterilization; actions taken to correct
deficiencies; and decisions related to patient notification of breaches
in dental equipment reprocessing or sterilization.
The dental RME reprocessing issues at the John Cochran Division
(JCD) were a long-standing problem that went unrecognized and
unaddressed by VISN and VAMC managers. VHA self-identified the
deficiencies and took actions to correct them; however, those actions
did not always resolve the issues. Responsible managers did not verify
the adequacy of RME reprocessing practices, nor did they assure that
corrective actions were consistently implemented in response to VHA
guidance and the Infectious Disease Program Office (IDPO) report. As a
result, SOPs were not developed in a timely manner for the reprocessing
of dental RME, SOPs did not always match manufacturers' instructions,
and Dental Clinic staff had not received training on dental RME pre-
treatment or reprocessing.
We concluded that the occurrence of a patient-to-patient
transmission of a blood-borne infectious disease at the JCD was
unlikely. Nevertheless, the Clinical Risk Board adhered to the process
outlined in VHA Directive 2008-002, Disclosure of Adverse Events to
Patients (January 18, 2008), when it recommended disclosure to 1,812
patients potentially affected by breaches in the cleaning and
sterilization processes. We concluded that the VAMC promptly set-up and
staffed its Dental Review Clinic, made appropriate efforts to contact
identified patients, and provided adequate support and follow-up to
patients.
We recommended that the VISN Director require the VAMC Director to
monitor the facility's compliance with all appropriate elements of RME
reprocessing, SOPs, staff training, and staff competencies as defined
in relevant VHA guidance; ensure that the VISN SPD Management Board
provides monitoring to ensure that SOPs based on manufacturer's
instructions are in place and that staff training and competencies are
current; and take appropriate administrative actions based on the
findings of the Administrative Board of Investigation and IDPO report.
The VISN and Medical Center Directors agreed with the findings and
recommendations
Combined Assessment Program Review Results
Despite the fact that VA leadership issued clear guidance to
facilities on standards for reprocessing RME and that Congress held
hearings on reprocessing failures at these sites, the OIG continues to
find non-compliance with VA directives. Because of the persistence of
deviations from expected performance by staff at VA facilities, a
review of RME reprocessing practices was included in the OIG's Combined
Assessment Program (CAP) reviews from January 1, 2010, through
September 30, 2010. \2\ Facility results were reported at the time of
the inspection and rolled up to present a representative view of the
system. We found that 87 percent of the reprocessing SOPs were
consistent with manufacturers' instructions and 92 percent were located
within the reprocessing areas. In our observations of employees
reprocessing equipment, the SOPs were followed 87 percent of the time.
Documented annual training was found for 82 percent of the employees
and item specific competencies were documented 87 percent of the time.
Proper protective equipment was worn by employees 89 percent of the
time. VA requires that RME activities (e.g. validation of staff
competency, compliance with established SOPs, results of infection
prevention and control monitoring, and risk management activities) be
reported to the Executive Committee of the Medical Staff (ECMS). Of the
45 facilities inspected in this CAP cycle, 37 (82 percent) had
documented ECMS discussion of all required elements. Compliance with
these standards at the 82 percent to 92 percent level is not sufficient
to ensure proper patient safety.
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\2\ Combined Assessment Program Summary Report, Evaluation of
Reusable Medical Equipment Practices in Veterans Health Administration
Facilities Report, March 14, 2011.
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Recommendations
A zero defects culture is essential at all VA medical facilities to
ensure patient safety and promote patient confidence. Employees and
managers must establish a climate of trust to ensure that RME is only
presented for patient use when it is in the appropriate condition.
Reprocessing high technology equipment and endoscopes can be
complex. The methods available to report that proper reprocessing has
occurred are not as clear as those used to indicate proper
sterilization has occurred. Users of devices that require reprocessing
must work with regulators and manufacturers to produce equipment that
reduces the likelihood of reprocessing errors. VA must consider a
variety of novel strategies from the method of procurement to the
support of applicable basic scientific research in its quest to insure
providers have equipment in the proper condition when patient care is
delivered.
VA's Disclosure of Adverse Events \3\ policy was one of the
Nation's earliest efforts to systematically address the issue. A recent
article in the medical literature, The Disclosure Dilemma, Large-Scale
Adverse Events,\4\ highlights some of the issues faced by institutions
as they struggle to deal with the application of the limits of science
and proper public policy. I believe it is time to have a national body
advise VA on potential changes to this policy in light of the broad
national experience with these complex issues.
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\3\ VHA Directive 2008-002, Disclosure of Adverse Events to
Patients, January 18, 2008.
\4\ Denise M. Dudzinski, Ph.D., Philip C. Hebert, M.D., Ph.D., Mary
Beth Foglia, R.N., Ph.D., and Thomas H. Gallagher, M.D., New England
Journal of Medicine, The Disclosure Dilemma, Large-Scale Adverse
Events, Volume 39, September 2, 2010.
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LEADERSHIP ISSUES
Leadership failures may endanger patients' lives. There have been
two recent occasions\5\ when facility staff deviated from RME
reprocessing standards resulting in VA CRAAB reviews. Failure to comply
with accepted infection control policies in the Dayton, Ohio, VAMC
Dental Clinic resulted in the notification to 535 veterans that dental
care may have put them at risk of acquiring blood borne viral
infections.
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\5\ Healthcare Inspection Patient Safety Issues VA Caribbean
Healthcare System San Juan, Puerto Rico, March 16, 2010; Healthcare
Inspection Oversight Review of Dental Clinic Issues Dayton VA Medical
Center Dayton, Ohio, April 25, 2011.
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In our recent report on the Dayton VAMC Dental Clinic, we concluded
that the subject dentist did not adhere to established infection
control guidelines and policies, and multiple dental clinic staff had
direct knowledge of these repeated infractions. These violations of
infection control policies placed patients at risk of acquiring
infections including those that are blood borne.
In our report on the VA Caribbean Healthcare System RME issues, we
substantiated multiple allegations including that senior system
leadership and responsible managers were aware of these issues but took
no action to assess the risk to patients.
In these instances, VA local leaders did not perform to the
expected standard and placed veterans' health at risk. It is imperative
that leaders take the appropriate actions to ensure compliance with
policies designed to ensure patients are not placed at risk of
preventable disease in the normal course of the delivery of patient
care.
Recommendations
Just as physicians have access to senior facility leaders via
clinical department leaders and nurses have access through the Chief
Nurse, VA clinical leaders should strive to receive unfiltered
information from the many technicians who are critical to the daily
delivery of quality medical care. Current lines of communication may
not be adequate to get the technicians concerns to facility leaders.
Ongoing discussions between the facilities leadership and the
hospital's technicians may provide important data necessary to improve
quality care.
Some successful organizations recognize that the rotation of
individuals through leadership positions or positions of special
responsibility provide a periodic check for the organization on its
adherence to policy. VA should consider how this management tool might
improve performance at network offices and at medical centers.
CONCLUSION
Clearly VA can perform better regarding RME reprocessing. Attention
from Congress and VA senior leadership has improved processes but
continuous attention to this issue at the medical center level will go
a long way to easing veterans concerns about the safety of medical
procedures and easing anxiety about having routine preventive tests
such as colonoscopies and regular dental check-ups.
Mr. Chairman, thank you for this opportunity and I would be pleased
to respond to any questions that you or other Members of the Committee
have.
Prepared Statement of Randall B. Williamson,
Director, Health Care, U.S. Government Accountability Office
VA HEALTHCARE: Weaknesses in Policies and Oversight
Governing Medical Equipment Pose Risks to Veterans' Safety
Chairman Miller, Ranking Member Filner, and Members of the
Committee:
I am pleased to be here today as you discuss patient safety
incidents at Department of Veterans Affairs (VA) medical centers and
potential strategies to address the underlying causes of those
incidents. VA operates one of the largest integrated healthcare
delivery systems in the United States, providing care to over 5.5
million veterans annually. Organized into 21 Veterans Integrated
Service Networks (VISN), VA's healthcare system includes 153 VA medical
centers (VAMC) nationwide that offer a variety of outpatient,
residential, and inpatient services.\1\ In providing healthcare
services to veterans, clinicians at VAMCs use reusable medical
equipment (RME), which is designed to be reused for multiple patients
and includes such equipment as endoscopes \2\ and some surgical and
dental instruments. Because RME is used when providing care to multiple
veterans, this equipment must be reprocessed, that is, cleaned and
disinfected or sterilized between uses. VA has established requirements
for VAMCs to follow when reprocessing RME,\3\ which are designed, in
part, to help ensure the safety of the veterans who receive care at
VAMCs.
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\1\ The management of VAMCs is decentralized to 21 VISNs.
\2\ An endoscope is a device with a light attached that is used to
look inside a body cavity or organ.
\3\ VA Handbook 7176, Supply, Processing, and Distribution (SPD)
Operational Requirements (Aug. 16, 2002); VHA Directive 2009-004, Use
and Reprocessing of Reusable Medical Equipment (RME) in Veterans Health
Administration Facilities (Feb. 9, 2009); and VHA Directive 2009-031,
Improving Safety in the Use of Reusable Medical Equipment Through
Standardization of Organizational Structure and Reprocessing
Requirements (June 26, 2009).
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My testimony today, based on our May 2011 report,\4\ which is being
released today, examines issues related to veterans' safety, including
(1) selected reprocessing requirements established in VA policies,
based on their relevance to patient safety incidents and (2) VA's
oversight of VAMCs' compliance with these selected requirements.
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\4\ See GAO, VA Health Care: Weaknesses in Policies and Oversight
Governing Medical Supplies and Equipment Pose Risks to Veterans'
Safety, GAO-11-391 (Washington, D.C.: May 2011).
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To examine VA reprocessing requirements, we reviewed relevant VA
policies and from these policies, we judgmentally selected the
following two types of reprocessing requirements that we determined
were relevant to patient safety incidents that were identified at
certain VAMCs. \5\
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\5\ We reviewed applicable VA policies, including VHA Directive
2009-031, Improving Safety in the Use of Reusable Medical Equipment
Through Standardization of Organizational Structure and Reprocessing
Requirements; VHA Directive 2009-004, Use and Reprocessing of Reusable
Medical Equipment (RME) in Veterans Health Administration Facilities;
and VA Handbook 7176, Supply, Processing, and Distribution (SPD)
Operational Requirements.
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Training requirements. To ensure that RME is reprocessed in
accordance with manufacturers' guidelines, VA requires that each VAMC
develop device-specific training for reprocessing RME. To develop this
training, VA requires VAMCs to create device-specific standard
operating procedures (SOP), which provide step-by-step instructions for
reprocessing. VA also requires VAMCs to assess staff annually on their
competence to reprocess RME in accordance with these SOPs.
Operational requirements. To ensure that reprocessing activities
are performed safely and that RME is reprocessed correctly, VA policies
establish operational requirements for VAMCs, which include that VAMC
staff must monitor sterilizers to ensure that they are functioning
properly, use personal protective equipment when performing
reprocessing activities, and segregate dirty and clean RME.
After selecting these requirements for our review, we judgmentally
selected six VAMCs from the following locations to visit: Albany, New
York; Cheyenne, Wyoming; Detroit, Michigan; Miami, Florida; Palo Alto,
California; and St. Louis, Missouri. These VAMCs represent different
surgical complexity groups,\6\ sizes of veteran populations served, and
geographic regions.\7\ At these six VAMCs, we examined the adequacy of
the selected reprocessing requirements to help the facilities ensure
the safety of veterans who received care at these facilities. To do
this, we examined how the selected requirements were implemented and
whether or to what extent these requirements directly or indirectly
created a potential risk to veterans' safety. We reviewed applicable
VAMC committee meeting minutes \8\ and other documentation on the
implementation of these requirements. We also interviewed VAMC
officials who were responsible for implementing the selected
requirements to determine whether these requirements are adequate to
help ensure veterans' safety.
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\6\ VA assigns each VAMC a complexity score between 1 and 3, with
level 1 being the most complex, using a facility complexity model. That
model uses multiple variables to measure facility complexity arrayed
along four categories, namely patient population served, clinical
services offered, education and research complexity, and administrative
complexity.
\7\ Each of the six VAMCs we visited is located within a different
VISN.
\8\ We reviewed minutes from the following committees: commodity
standards, equipment, medical executive, infection control, and RME.
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To examine VA's oversight of VAMCs' compliance with the selected
reprocessing requirements, we reviewed VA's oversight of these
requirements and evaluated whether this oversight provides VA with
adequate information to identify and address noncompliance. As part of
this review, we assessed VA's oversight in the context of Federal
standards for internal control for monitoring.\9\ The internal control
for monitoring refers to an agency's ability to assure that ongoing
review and supervision activities are conducted, with the scope and
frequency depending on the assessment of risks; deficiencies are
communicated to at least one higher level of management; and actions
are taken in response to findings or recommendations within established
timelines. We interviewed officials responsible for overseeing VAMCs'
compliance with the requirements we selected for review from VA
headquarters, VA's Office of Inspector General (OIG), and six VISNs
that are responsible for overseeing compliance with the requirements we
selected for review at the VAMCs we visited. In addition, we obtained
and reviewed relevant documents regarding VA oversight, including
internal reports, VAMCs' plans to correct problems identified through
oversight activities, and policy memorandums.
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\9\ See GAO, Standards for Internal Control in the Federal
Government, GAO/AIMD-00-21.3.1 (Washington, D.C.: November 1999) and
GAO, Internal Control Management and Evaluation Tool, GAO-01-1008G
(Washington, D.C.: August 2001).
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We conducted this performance audit from March 2010 to May 2011 in
accordance with generally accepted government auditing standards. Those
standards require that we plan and perform the audit to obtain
sufficient, appropriate evidence to provide a reasonable basis for our
findings and conclusions based on our audit objectives. We believe that
the evidence obtained provides a reasonable basis for our findings and
conclusions based on our audit objectives.
In summary, we found that the VA reprocessing requirements we
selected for review are inadequate to help ensure the safety of
veterans who receive care at VAMCs. Although VA requires VAMCs to
develop device-specific training for staff on how to correctly
reprocess RME, it has not specified the types of RME for which this
training is required. Furthermore, VA has provided conflicting guidance
to VAMCs on how to develop device-specific training on reprocessing
RME.\10\ This lack of clarity may have contributed to delays in
developing the required training. Without appropriate training on
reprocessing, VAMC staff may not be reprocessing RME correctly, which
poses potential risks to veterans' safety. VA headquarters officials
told us that VA has plans to develop training for certain RME, but VA
lacks a timeline for developing this training.
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\10\ According to VA headquarters officials, certain RME are
difficult to reprocess because they need to be fully disassembled in
order to be reprocessed correctly, so developing device-specific
training for reprocessing these items is important to help ensure
veterans' safety.
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We also found that despite changes to improve VA's oversight of
VAMCs' compliance with selected reprocessing requirements, weaknesses
still exist. These weaknesses render VA unable to systematically
identify and address noncompliance with the requirements, which poses
potential risks to the safety of veterans. Although VA headquarters
receives information from the VISNs on any noncompliance they identify,
as well as VAMCs' corrective action plans to address this
noncompliance, VA headquarters does not analyze this information to
inform its oversight. According to VA headquarters officials, VA
intends to develop a plan for analyzing this information to
systematically identify areas of noncompliance that occur frequently,
pose high risks to veterans' safety, or have not been addressed across
all VAMCs.
To address the inadequacies we identified in selected VA
reprocessing requirements, GAO recommends that VA develop and implement
an approach for providing standardized training for reprocessing all
critical and semi-critical RME to VAMCs and hold VAMCs accountable for
implementing this training. To address the weaknesses in VA's oversight
of VAMCs' compliance with selected requirements, GAO recommends that VA
use information on noncompliance identified by the VISNs and
information on VAMCs' corrective action plans to identify areas of
noncompliance across all 153 VAMCs and take action to improve
compliance in those areas.
Selected VA Reprocessing Requirements Are Inadequate to Help Ensure
Veterans' Safety
We found that the VA reprocessing requirements we selected for
review are inadequate to help ensure veterans' safety.
Lack of specificity about types of RME that require device-specific
training. The VA reprocessing requirements we reviewed do not specify
the types of RME for which VAMCs must develop device-specific training.
This inadequacy has caused confusion among VAMCs and contributed to
inconsistent implementation of training for reprocessing. While VA
headquarters officials told us that the training requirement is
intended to apply to RME classified as critical, such as surgical
instruments, and semi-critical, such as certain endoscopes,\11\
officials from five of the six VAMCs we visited told us that they were
unclear about the RME for which they were required to develop device-
specific training.
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\11\ RME is generally categorized into critical, semi-critical, or
non-critical items based on the degree of risk for infection involved
in use of the item. Critical items, such as surgical instruments, are
those that enter sterile tissue or the vascular system and require
sterilization because they confer a high risk of infection. Semi-
critical items, such as certain endoscopes, are those that contact
mucous membranes or non-intact skin and minimally require high-level
disinfection. Non-critical items, such as wheelchairs, are those that
come into contact with intact skin and may be cleaned with low-level
disinfectants.
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Officials at one VAMC we visited told us that they did not develop
all of the required reprocessing training for critical RME, such as
surgical instruments, because they did not understand that they were
required to do so. Officials at another VAMC we visited also told us
that they had begun to develop device-specific training for
reprocessing non-critical RME, such as wheelchairs, even though they
had not yet fully completed device-specific training for more critical
RME. Because these two VAMCs had not developed the appropriate device-
specific training for reprocessing critical and semi-critical RME,
staff at these VAMCs may not have been reprocessing all RME properly,
which potentially put the safety of veterans receiving care at these
facilities at risk.
Conflicting guidance on the development of RME reprocessing
training. While VA requires VAMCs to develop device-specific training
on reprocessing RME, VA headquarters officials provided VAMCs with
conflicting guidance on how they should develop this training. For
example, officials at three VAMCs we visited told us that certain VA
headquarters or VISN officials stated that this device-specific
training should very closely match manufacturer guidelines in one case
verbatim, while other VA headquarters or VISN officials stated that
this training should be written in a way that could be easily
understood by the personnel responsible for reprocessing RME. This
distinction is important, since VAMC officials told us that some of the
staff responsible for reprocessing RME may have difficulty following
the more technical manufacturers' guidelines.\12\ In part because of
VA's conflicting guidance, VAMC officials told us that they had
difficulty developing the required device-specific training and had to
rewrite the training materials multiple times for RME at their
facilities. Officials at five of the six VAMCs also told us that
developing the device-specific training for reprocessing RME was both
time consuming and resource intensive.
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\12\ VA officials stated that manufacturer guidelines for
reprocessing RME may be technically complex and may include steps that
staff at VAMCs are unable to follow. For example, these officials
stated that guidelines from RME manufacturers may require the use of a
specific disinfectant that is not available in the United States. The
Food and Drug Administration has responsibility for overseeing RME,
including the guidelines written by manufacturers for reprocessing
these items.
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VA's lack of specificity and conflicting guidance regarding its
requirement to develop device-specific training for reprocessing RME
may have contributed to delays in developing this training at several
of the VAMCs we visited. Officials from three of the six VAMCs told us
that that they had not completed the development of device-specific
training for RME since VA established the training requirement in July
2009. As of October 2010, 15 months after VA issued the policy
containing this requirement, officials at one of the VAMCs we visited
told us that device-specific training on reprocessing had not been
developed for about 80 percent of the critical and semi-critical RME in
use at their facility.
VA headquarters officials told us that they are aware of the lack
of specificity and conflicting guidance provided to VAMCs regarding the
development of training for reprocessing RME and were also aware of
inefficiencies resulting from each VAMC developing its own training for
reprocessing types of RME that are used in multiple VAMCs. In response,
VA headquarters officials told us that they have made available to all
VAMCs a database of standardized device-specific training developed by
RME manufacturers for approximately 1,000 types of RME and plan to
require VAMCs to implement this training by June 2011. The officials
also told us that VA headquarters is planning to develop device-
specific training available to all VAMCs for certain critical and semi-
critical RME for which RME manufacturers have not developed this
training, such as dental instruments. However, as of February 2011, VA
headquarters had not completed the development of device-specific
training for these RME and has not established plans or corresponding
timelines for doing so.
Despite Changes Intended to Improve VA's Oversight of VAMCs' Compliance
with Selected Reprocessing Requirements, Weaknesses Continue to
Exist
We found that VA recently made changes to its oversight of VAMCs'
compliance with selected reprocessing requirements; however, this
oversight continues to have weaknesses. Beginning in fiscal year 2011,
VA headquarters directed VISNs to make three changes intended to
improve its oversight of these reprocessing requirements at VAMCs.\13\
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\13\ VA headquarters generally delegates responsibility for this
oversight to the VISNs. In addition to oversight conducted by the
VISNs, some entities within VA headquarters conduct oversight of VAMCs'
compliance with VA reprocessing requirements, including those we
selected for review. Specifically, VA's OIG and Sterile Processing
Department conduct site visits to investigate allegations of VAMC
noncompliance with VA reprocessing requirements. In addition, since
around 2005, VA's System-wide Ongoing Assessment and Review Strategy
has included reviews of the selected VA reprocessing requirements as
part of broader reviews of VAMC compliance with VA policies in
preparation for external accreditation reviews approximately every 3
years. In 2010, VA's OIG also conducted reviews of the selected VA
reprocessing requirements as part of broader ongoing reviews of VAMC
compliance with VA policies.
VA headquarters recently required VISNs to increase the
frequency of site visits to VAMCs, from one to three unannounced site
visits per year, as a way to more quickly identify and address areas of
noncompliance with selected VA reprocessing requirements.
VA headquarters also recently required VISNs to begin
using a standardized assessment tool to guide their oversight
activities.\14\ According to VA headquarters officials, requiring VISNs
to use this assessment tool will enable the VISNs to collect consistent
information on VAMCs' compliance with VA's reprocessing requirements.
Before VA established this requirement, the six VISNs that oversee the
VAMCs we visited often used different assessment tools to guide their
oversight activities. As a result, they reviewed and collected
different types of information on VAMCs' compliance with these
requirements.
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\14\ VA headquarters officials told us that they may refine this
assessment tool over time.
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VISNs are now required to report to VA headquarters
information from their site visits. Specifically, following each
unannounced site visit to a VAMC, VISNs are required to provide VA
headquarters with information on the facility's noncompliance with VA's
reprocessing requirements and VAMCs' corrective action plans to address
areas of noncompliance. Prior to fiscal year 2011, VISNs were generally
not required to report this information to VA headquarters.\15\
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\15\ While VISNs were not generally required to report to VA
headquarters information on VAMCs' noncompliance with VA's reprocessing
requirements, VISNs were required to report to VA headquarters
information about noncompliance that may have resulted in harm to
veterans. VA headquarters officials told us that following a review of
that information and collection of additional information as needed, a
panel of experts would determine whether the noncompliance identified
in the reviews resulted in risks to veterans' safety and, if so,
whether veterans should be notified. See VHA Directive 2008-002,
Disclosure of Adverse Events to Patients (Washington, D.C.: Jan. 18,
2008).
Despite the recent changes, VA's oversight of its reprocessing
requirements, including those we selected for review, has weaknesses in
the context of the Federal internal control for monitoring. Consistent
with the internal control for monitoring, we would expect VA to analyze
this information to assess the risk of noncompliance and ensure that
noncompliance is addressed. However, VA headquarters does not analyze
information to identify the extent of noncompliance across all VAMCs,
including noncompliance that occurs frequently or poses high risks to
veterans' safety. As a result, VA headquarters has not identified the
extent of noncompliance across VAMCs with, for example, VA's
operational reprocessing requirement that staff use personal protective
equipment when performing reprocessing activities, which is key to
ensuring that clean RME are not contaminated by coming into contact
with soiled hands or clothing. Three of the six VAMCs we visited had
instances of noncompliance with this requirement. Similarly, because VA
headquarters does not analyze information from VAMCs' corrective action
plans to address noncompliance with VA reprocessing requirements, it is
unable to confirm, for example, whether VAMCs have addressed
noncompliance with its operational reprocessing requirement to separate
clean and dirty RME. Two of the six VAMCs we visited had not resolved
noncompliance with this requirement and, as a result, are unable to
ensure that clean RME does not become contaminated by coming into
contact with dirty RME.
VA headquarters officials told us that VA plans to address the
weaknesses we identified in its oversight of VAMCs' compliance with
reprocessing requirements. Specifically, VA headquarters officials told
us that they intend to develop a systematic approach to analyze
oversight information to identify areas of noncompliance across all
VAMCs, including those that occur frequently, pose high risks to
veterans' safety, or have not been addressed in a timely manner.\16\
While VA has established a timeline for completing these changes,
certain VA headquarters officials told us that they are unsure whether
this timeline is realistic due to possible delays resulting from VA's
ongoing organizational realignment, which had not been completed as of
April 6, 2011.\17\
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\16\ VA headquarters officials also told us that a temporary staff
member was assigned in March 2011 to begin reviewing some information
from VISNs' oversight activities. Specifically, that staff member will
be responsible for reviewing whether VAMCs have developed the required
device-specific training for reprocessing RME and the extent to which
VAMCs are utilizing flash sterilization, a sterilization technique that
should be used only in limited circumstances.
\17\ As part of this realignment, VA headquarters is establishing a
new position within the Office of the Deputy Under Secretary for Health
for Operations and Management, which will be responsible for overseeing
certain departments, including VA headquarters' Sterile Processing
Department.
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In conclusion, weaknesses exist in VA's policies for reprocessing
RME that create potential safety risks to veterans. VA's lack of
specificity and conflicting guidance for developing device-specific
training for reprocessing RME has led to confusion among VAMCs about
which types of RME require device-specific training and how VAMCs
should develop that training. This confusion has contributed to some
VAMCs not developing training for their staff for some critical and
semi-critical RME.
Moreover, weaknesses in oversight of VAMCs' compliance with the
selected reprocessing requirements do not allow VA to identify and
address areas of noncompliance across VAMCs, including those that occur
frequently, pose high risks to veterans' safety, or have not been
addressed by VAMCs. Correcting inadequate policies and providing
effective oversight of reprocessing requirements consistent with the
Federal standards for internal control is essential for VA to prevent
potentially harmful incidents from occurring.
To help ensure veterans' safety through VA's reprocessing
requirements, we are making two recommendations in our report. We
recommend that the Secretary of Veterans Affairs direct the Under
Secretary for Health to take the following actions:
Develop and implement an approach for providing
standardized training for reprocessing all critical and semi-critical
RME to VAMCs. Additionally, hold VAMCs accountable for implementing
device-specific training for all of these RME.
Use the information on noncompliance identified by the
VISNs and information on VAMCs' corrective action plans to identify
areas of noncompliance across all 153 VAMCs, including those that occur
frequently, pose high risks to veterans' safety, or have not been
addressed, and take action to improve compliance in those areas.
In responding to a draft of the report from which this testimony is
based, VA concurred with these recommendations.
Chairman Miller, Ranking Member Filner, this concludes my prepared
statement. I would be happy to respond to any questions you or other
Members of the Committee may have.
Contacts and Acknowledgments
For further information about this testimony, please contact
Randall B. Williamson at (202) 512-7114 or [email protected]. Contact
points for our Offices of Congressional Relations and Public Affairs
may be found on the last page of this testimony. Individuals who made
key contributions to this testimony include Mary Ann Curran, Assistant
Director; Kye Briesath; Krister Friday; Melanie Krause; Lisa Motley;
and Michael Zose.
Prepared Statement of Michael Bell, M.D., Deputy Director,
Division of Healthcare Quality Promotion Centers for Disease Control
and
Prevention, U.S. Department of Health and Human Services
Good morning Chairman Miller, Ranking Member Filner and other
distinguished Members of the Committee. I am Dr. Michael Bell, Deputy
Director of the Division of Healthcare Quality Promotion at the Centers
for Disease Control and Prevention (CDC). I am pleased to be here to
discuss the prevention of healthcare-associated infections (HAIs) and
ensuring safe healthcare nationwide.
Healthcare associated infections are infections that patients
acquire while receiving care. They include a variety of infections
ranging from those related to specialized intensive care procedures to
infections caused by lapses in basic safe practices, like re-using
disposable syringes or inappropriate reprocessing of equipment. CDC
estimates that approximately 1 in 20 hospital patients have HAIs. These
infections are associated with increased mortality and greater cost of
care; and can occur in any healthcare setting--hospitals, long-term
care, dialysis clinics, ambulatory surgical centers, and even doctors'
offices. As complex care is increasingly delivered in non-hospital
settings, we are seeing a concomitant increase in potentially life-
threatening infections related to care outside of hospitals. Infections
caused by lapses in basic infection control are unacceptable. We know
how to protect patients from these events; they can and must be
prevented.
Based on CDC data, the four most frequent infections related to
specialized care procedures accounting for approximately three quarters
of HAIs are: 1) urinary tract infections; 2) surgical site infections;
3) bloodstream infections; and 4) pneumonia. These infections are
caused by both common pathogens such as Staphylococcus aureus,
including Methicillin-resistant Staphylococcus aureus (MRSA), and by
emerging pathogens such as drug-resistant Klebsiella pneumoniae. In
addition, we continue to see egregious failures in basic infection
control and safety practices (e.g., using the same syringe to
administer medication to more than one patient) that have resulted in
transmission of blood borne and other pathogens (i.e., hepatitis C
virus, [HCV], hepatitis B virus [HBV]). HAIs in hospitals alone result
in excess healthcare costs of an estimated $26 to $33 billion each
year. Yet, most HAIs are preventable. HHS and its public and private
sector partners are working together to eliminate these costly and
deadly infections. HHS recently launched the Partnership for Patients:
Better Care, Lower Costs, a new public-private partnership that will
help improve the quality, safety and affordability of healthcare for
all Americans. The Partnership for Patients brings together leaders of
major hospitals, employers, health plans, physicians, nurses, and
patient advocates along with State and Federal Governments in a shared
effort to make hospital care safer, more reliable, and less costly.
The Centers for Disease Control and Prevention, working with
several other agencies in the U.S. Department of Health and Human
Services, has taken a lead role in addressing the important public
health challenge of preventing HAI's by identifying and implementing
prevention strategies, providing guidelines for prevention, monitoring
HAIs and tracking prevention progress, and detecting and responding to
emerging threats.
The HHS Action Plan to Prevent HAIs sets specific targets for
monitoring and preventing HAIs nationally and represents a national
blueprint for promoting HAI prevention. CDC has played an integral role
in the HHS led effort to develop and implement the HHS Action Plan,
including chairing the Prevention and Implementation working group and
co-chairing the Information Systems and Technology working group. Since
the release of the initial HHS Action Plan, CDC has collaborated
closely with the HHS Assistant Secretary for Health, the Agency for
Healthcare Research and Quality (AHRQ), the Centers for Medicare and
Medicaid Services (CMS), the Department of Veterans Affairs (VA), and
other Federal agencies to expand and implement the HHS Action Plan to
include ambulatory surgical centers and hemodialysis centers.
There has been significant progress in several areas; however more
work is needed to ensure that appropriate infection control practices
are adhered to in all healthcare settings. The VA has been an important
partner in implementing HHS HAI prevention initiatives. However, recent
infection control lapses, such as those at VA facilities in Dayton OH,
St. Louis MO, and Miami FL, demonstrate the need for constant
vigilance.
Today, I will focus my remarks on 3 specific areas: 1) the issue of
basic infection control in healthcare, including CDC's efforts to
prevent them; 2) CDC's collaborations with the VA related to HAIs; and
3) recommended strategies to halt improper practices when they are
identified and to notify patients that were exposed to those practices.
Healthcare-Associated Infections Related to Failure to Maintain Basic
Infection Control
CDC has worked with State and local health departments to identify
numerous breaches in basic infection control practices in recent years.
Infections acquired through lapses in basic infection control practices
are generally through an intermediate device or material. A medical
device (e.g., syringe, needle, lancet) or medication becomes
contaminated with an infectious agent and the infectious agent is then
passed to a previously uninfected patient through inappropriate
exposure to the contaminated material. Examples of improper practices
include:
Using the same syringe to administer medication to more
than one patient;
Accessing a shared medication vial with a syringe that
has already been used to administer medication to a patient; and
Performing finger stick blood sampling with a reused
lancing device or checking blood glucose levels with a blood-
contaminated glucose meter.
Improper reprocessing (i.e., cleaning and disinfection)
of endoscopes
Improper reprocessing and sterilization of medical
equipment (e.g., surgical equipment)
Improper reuse of medical devices (e.g., syringes,
prostate biopsy needle guides)
These unacceptable practices put patients at risk of infectious and
non-infectious adverse events and have been associated with a wide
variety of procedures. Unfortunately, these practices are occurring
across the healthcare spectrum and in non-acute care settings outside
of hospitals, where infection control capacity is often less extensive
and oversight more limited.
Healthcare should never be a conduit for transmission of
infections. Basic infection control practices have long been
established as part of the evidence-based and common sense precautions
that are necessary to prevent transmission of pathogens.
CDC's Efforts to Prevent HAIs Due to Failure To Maintain Basic
Infection Control
Leading the Nation's efforts to protect patients from transmission
of pathogens due to lapses in infection control during healthcare
delivery, CDC is engaged in a number of efforts to eliminate these
events, including:
development and implementation of HAI prevention
guidelines,
development of survey tools to evaluate facilities'
adherence to infection control practices,
identifying and responding to new and emerging threats to
patient safety,
educating healthcare providers and patients in basic
infection control, and
promoting development of safer medical devices.
Development and Implementation of Infection Prevention Recommendations
CDC, working with the HHS Healthcare Infection Control Practices
Advisory Committee (HICPAC), develops evidence-based guidelines for HAI
prevention. Key existing guidelines include: (1) the Guideline for
Disinfection and Sterilization in Healthcare Facilities, 2008,
presenting evidence-based recommendations on the preferred methods for
cleaning, disinfection and sterilization of medical equipment and for
cleaning and disinfecting the healthcare environment, (2) the
Guidelines for Environmental Infection Control in Health-Care
Facilities, 2003, a compilation of recommendations for the prevention
and control of infectious diseases that are associated with healthcare
environments, and (3) the 2007 Guideline for Isolation Precautions:
Preventing Transmission of Infectious Agents in Healthcare Settings.
CDC and HICPAC also developed summary recommendations specifically for
ambulatory care targeting basic infection control practices that should
be used in all healthcare settings. CDC has worked with professional
associations to reach out to healthcare professionals and is
collaborating with CMS to incorporate CDC guidelines into CMS practice
requirements.
Tools To Improve Basic Infection Control
CDC develops tools to translate CDC and HICPAC guidelines into
practice. For example, CDC is improving basic infection control
practices through collaborations with CMS to expand survey and
oversight capacity of non-acute healthcare settings. CDC and CMS worked
together to develop a new tool that state inspectors can use to better
ensure the quality of care in ambulatory surgical centers (ASCs); use
of the tool has been expanded nationwide. In a 2008 Federal survey of
ASCs, 68 percent of 68 surveyed had noncompliance with the infection
control requirements in the Medicare ASC health and safety standards.
CMS has found infection control problems in ASCs to be both common and
egregious, ranging from failure to clean equipment between patients and
re-use of single-dose vials of medication for multiple patients. CDC is
working with CMS to expand incorporation of basic infection control
content into CMS interpretive guidance for their conditions of
coverage. The tool has now been adapted for use in nursing homes and
used to assess infection control practices in Nevada nursing homes. CDC
continues to work with CMS to develop similar tools for use in acute
care and other healthcare settings.
Breaches in basic infection control practices have put greater
focus on the authorities and role of State and local health departments
in ensuring patient safety. State licensure boards can promote ongoing
training and certification as a part of licensure requirements for
healthcare professionals. State health departments play critical public
health roles in preventing harm due to incorrect practices, including
issuance of cease and desist notices when necessary.
Identifying and Responding To New and Emerging Threats
CDC serves as a national and global leader in the investigation and
control of HAI outbreaks. Through its investigations, CDC identifies
problems, develops new prevention strategies, and works with partner
agencies such as the Food and Drug Administration (FDA) to implement
policy changes. Investigation of single suspect cases has in many
instances led to the detection of sizable outbreaks, highlighting the
point that recognized outbreaks are usually only the tip of the
iceberg. Outbreaks often reveal unsafe practices and can require large
scale patient notifications (as described below). Countless infections
were prevented because of interventions that were implemented in
collaboration with FDA and other partners to stop these outbreaks,
including the identification and recall of contaminated or defective
products, changes in device construction, revised recommendations for
device use, closure of non-compliant facilities, and recommendation of
new practices to prevent additional infections.
CDC deploys experts including healthcare epidemiologists,
infectious disease physicians, and laboratory scientists to assess
healthcare settings, collect and analyze data, evaluate practices, and
perform microbiologic testing in response to a recognized outbreak or
problem. CDC has assisted with laboratory testing of patients put at
risk for hepatitis. Information from these investigations not only
serves to control the immediate problem, but also has a direct impact
on future HAI prevention nationwide. Experience from outbreak
investigations also contributes to refinement of infection control
guidelines and improvements in HAI tracking.
Viral hepatitis is a reportable condition in all States, but our
ability to detect transmission in healthcare settings through this
routine surveillance is limited because the system relies on passive
reporting and in many cases we cannot evaluate how patients became
infected. Therefore, CDC provides funding to several States to conduct
enhanced viral hepatitis surveillance through the Emerging Infections
Program (EIP). A case control study was conducted as part of the EIP
activity to examine the role of healthcare exposures among older adults
with acute hepatitis B and C. Results of this study indicate that viral
hepatitis infections transmitted to individual patients in healthcare
settings represent a significant but under-recognized problem.
Promotion of Infection Control Through Education
CDC is working with partners through the Safe Injection Practices
Coalition (SIPC), a partnership of healthcare-related organizations,
professional organizations, and patient advocacy groups, that promote
safe injection practices in healthcare settings. Through CDC funding,
the SIPC developed the One & Only Campaign--a public health education
and awareness campaign--aimed at both healthcare providers and patients
to advance and promote safe injection practices and implemented the
campaign in Nevada, New York, and New Jersey. In addition, CDC has
disseminated almost 5,000 DVDs and logged over 20,000 online views of a
10-minute educational video for healthcare providers on safe injection
practices launched in collaboration with the SIPC.
Promoting Development of Safer Medical Devices
CDC is working to promote innovation and development of product and
marketing improvements to protect patients. For example after the
identification of several outbreaks of viral hepatitis resulting from
shared use of fingerstick (lancing) devices and point of care blood
testing devices for glucose monitoring, in August 2010, the FDA, CDC,
and CMS issued clinical reminders and public health notifications
highlighting the risk of transmission of disease from these devices.
FDA is working with manufacturers to ensure that adequate labeling and
instructions for use are provided to healthcare personnel so that they
can adhere to recommended practices.
CDC's Collaborations With the VA To Prevent Infections
CDC's efforts to eliminate HAIs are amplified through close
collaborations with a range of Federal agencies, including the VA. The
VA has been directly involved with CDC in many of the efforts outlined
above. A senior representative from the VA serves as an ex-officio
member of HICPAC, and as such is engaged in the ongoing development of
infection prevention guidelines and strategies for surveillance and
prevention of HAIs. The VA is also engaged in HHS inter-agency
initiatives to improve and expand HAI prevention efforts, including the
HHS Steering Committee for the Prevention of Healthcare-Associated
Infections, of which the VA is an active member. CDC has worked with
the VA in the investigation and response to lapses in basic infection
control at VA medical facilities.
The VA hospital system has been a leader in implementing CDC and
HICPAC infection prevention recommendations. CDC has directly partnered
with the VA to implement prevention initiatives resulting in a 60
percent reduction of MRSA in VA facilities over a 32 month period,
initially as a pilot project at the local level and ultimately
translated into regional and national programs. CDC is working with
several groups to assess the effectiveness of several other successful
implementation strategies. These and other prevention implementation
examples demonstrate the savings in lives and healthcare costs that can
result from national implementation of evidence-based HAI prevention
programs.
When Infections Occur
The ultimate goal is to ensure that all healthcare is delivered
safely across the spectrum of healthcare delivery; however, when an
infection control failure is identified, there is a need to notify
patients who might have been exposed and to protect other patients from
harm. During the past decade, over 120,000 patients had to be notified
of the need to seek testing in the context of two dozen incidents and
outbreaks involving unsafe injections; additional patients have been
notified of risks associated with other errors, such as improper
sterilization of equipment. In addition to Federal oversight and
payment policies to drive prevention of unsafe practices, local and
State authorities are necessary to temporarily or permanently halt
unsafe medical practices. Once halted, strategies for identifying
exposed individuals are needed so that those put at risk by incorrect
practices can be notified and provided care.
Patient Notifications
When failures of infection control result in a need to notify
patients who were put at risk, such notifications and the accompanying
diagnostic testing can be resource and labor intensive and are not
without potential harm to patients notified. Decisions regarding
notification of exposed patients when there is no evident disease
transmission are challenging. CDC has engaged diverse partners that
include State and local health departments, patient advocates, public
health professionals, ethicists, healthcare industry representatives,
and the Safe Injection Practices Coalition to discuss and obtain input
on the ethical and communication issues related to such patient
notification. CDC also hosted six focus groups in New York and Atlanta
to identify best practices for notification. CDC's Public Health Ethics
Committee also informed the process.
Based on the process described, CDC has developed recommendations
for determining whether patient notification should be initiated and
how best to do so. This includes evaluation of the problem in order to
classify it as Category A: a gross error or demonstrated high-risk
practice (e.g., reuse of needles or syringes between patients or use of
contaminated syringes to access shared medication vials), or Category
B: an error with lower likelihood of blood exposure (e.g., endoscope
reprocessing errors). Patient notifications are indicated for Category
A. When an error is classified as Category B and there is no known
transmission of blood borne or other pathogens, decisions should be
based on several factors, including the risk of infection, the duty to
warn versus the potential harm to patients from the notification, and
addressing public concerns.
CDC is currently developing a patient notification communications
toolkit based on the information gathered through the process above.
The toolkit will contain resources for developing documents for patient
notification (e.g., sample notification letters, sample patient test
results letter, resources for risk communication); establishing
communication resources (e.g., setting up a call center); planning
media and communication strategies (e.g., sample press release); and
best practices for patient notification (e.g. planning the release of
media and notification letters, communicating with key stakeholders and
partners).
CDC has met with and continues to work with the VA to share CDC's
recommended practices for patient notifications.
Conclusion
Ensuring that appropriate infection control practices are adhered
to in all healthcare settings is a priority for CDC. Public health
plays an important role in ensuring a unified approach through
systematic implementation of prevention practices, monitoring to detect
problems, outbreak investigation and control, oversight, education, and
research. As healthcare continues to grow in complexity and is
increasingly provided in outpatient settings such as ambulatory
surgical centers, dialysis centers, and nursing homes, where infection
control programs and oversight are generally less rigorous, outbreaks
from transmission of pathogens through lapses in basic infection
control practices have grown. As a result, CDC has undertaken a number
of efforts to evaluate the problem and develop prevention strategies so
that these errors do not recur. Many of these efforts are in
collaboration with diverse partners, including the VA, allowing for
broad implementation of recommended practices.
As we continue to work toward elimination of HAIs, new healthcare
settings and changing technology will create new challenges and will
require continued vigilance. CDC continues to strive to address those
challenges and ensure that patients are safe in every healthcare
setting. Infections caused by lapses in basic infection control are
unacceptable. We know how to protect patients from these events; they
can and must be prevented.
Thank you for the opportunity to testify today; I am happy to take
any questions you may have.
Prepared Statement of Anthony D. Watson, BS, MS, MBA, Director,
Division of Anesthesiology, General, Hospital, Infection Control, and
Dental Devices, Office of Device Evaluation, Center For Devices and
Radiological Health, Food and Drug Administration,
U.S. Department of Health and Human Services
Introduction
Mr. Chairman, Ranking Member Filner, and Members of the Committee,
I am AnthonyD. Watson, Director, Division of Anesthesiology, General
Hospital, Infection Control, and Dental Devices, Office of Device
Evaluation, Center for Devices and Radiological Health (CDRH) at the
Food and Drug Administration (FDA or the Agency). Thank you for the
opportunity to discuss reprocessing of reusable medical devices and the
importance of adequate reprocessing to protect patient safety. FDA is
committed to working with our partners in industry, government and care
settings to ensure patients are not at risk from unacceptable lapses in
patient safety practices related to the reprocessing of medical
devices. Today, I will provide you with an overview of medical device
regulation, discuss the background on reprocessed medical devices, and
describe actions FDA is taking to address safety concerns related to
reprocessing of reusable medical devices.
Overview of Device Regulation
A medical device, as defined by Federal law, encompasses several
thousand health products, from simple articles such as tongue
depressors and heating pads to cutting-edge and complex devices such as
implantable defibrillators and robotic equipment for minimally invasive
surgery.
The Medical Device Amendments of 1976 to the Federal Food, Drug,
and Cosmetic Act (FD&C Act or the Act) gave FDA specific authority to
regulate the safety and effectiveness of medical devices. Medical
devices are assigned to one of three regulatory classes based on risk.
Class I, General Controls, is the lowest risk category of devices
and includes items such as adhesive bandages. These devices are subject
to the General Controls of the Act, which include establishment
registration and device listing, compliance with current Good
Manufacturing Practice (cGMP) and labeling, recordkeeping, and
reporting requirements.
Class II, Special Controls, is the next category of risk and
includes devices such as intravenous catheters and powered wheelchairs.
They are subject to the General Controls of the Act as well as Special
Controls, which may include special labeling requirements, mandatory
performance standards, and post-market surveillance, in order to
provide reasonable assurance of the safety and effectiveness of the
device.
Class III is the highest risk category of device and includes
devices such as heart valves and coronary stents. These devices are
subject to the General Controls of the Act, plus approval prior to
marketing of a premarket approval application containing scientific
evidence of the device's safety and effectiveness.
Adverse Event Reporting
Once a medical device is marketed, FDA monitors reports of adverse
events and alerts health professionals and the public when needed to
ensure proper use of devices and the health and safety of patients. FDA
uses two principal systems to capture device-related adverse event and
product problem reports: the Medical Device Reporting regulation (MDR)
and the Medical Product Safety Network (MedSun).
MDR is the mechanism by which FDA receives over 300,000 significant
medical device adverse events annually from manufacturers, importers,
and user facilities, including hospitals. FDA carefully evaluates the
reports received to identify safety concerns of public health
importance, such as product problems that could potentially cause
injury. User facilities are required to report deaths to the
manufacturer and FDA and serious injuries to the manufacturer.
Manufacturers must report to FDA within 30 days deaths, serious
injuries, and malfunctions that could contribute to a death or serious
injury. FDA also receives voluntary reports from many different sources
including consumers and healthcare professionals.
The limitations inherent in passive reporting systems such as MDR,
include underreporting of adverse events, the submission of incomplete
or difficult-to-understand reports, and insufficient information to
accurately identify the product in question. Recognizing the
limitations of passive reporting systems, FDA launched MedSun in 2002.
MedSun is an ``active'' adverse event reporting program that allows FDA
to work collaboratively with the clinical community to identify,
understand, and solve problems with the use of medical devices. Over
350 healthcare facilities, primarily hospitals, participate in the
MedSun Network.
Facilities participating in the MedSun Network use an Internet-
based system to report adverse medical device events to FDA. MedSun
facility reporting differs from the other (mandatory) user facility
reporting because MedSun participants not only report medical device
problems that result in serious injury or death, but they also are
encouraged to voluntarily report problems with devices, such as
``close-calls,'' potential for harm, and other safety concerns.
In general, FDA may become aware of device-related or associated
adverse events that occur in hospitals through the following
mechanisms:
1. the hospital submits an MDR directly to FDA (as described
above);
2. a voluntary report from a clinician or patient associated with
the hospital and/or the event;
3. a report to the MedSun program (if the hospital is in the
program, as described above);
4. the hospital submits information regarding the event to the
manufacturer, who then reports an MDR to FDA as part of their MDR
reporting obligation; and
5. through the Centers for Disease Control and Prevention (CDC)
when it undertakes a possible outbreak investigation at the request of
a State health department.
Reprocessing of Reusable Medical Equipment
Reusable medical devices are devices that are designed and labeled
for use on multiple patients and are made of materials that can
withstand repeated reprocessing, including manual brushing and the use
of chemicals. Some examples of reusable medical devices are surgical
instruments, such as clamps and forceps; endoscopes, used to visualize
areas inside the body; and accessories to endoscopes, such as
arthroscopic shavers; and laparoscopic surgery accessories, such as
graspers and scissors.
All reusable medical devices can be grouped into one of three
categories according to the degree of risk of infection associated with
their use:
Critical devices, such as surgical forceps that come in
contact with the bloodstream or normally sterile tissue.
Semi-critical devices, such as certain endoscopes that
come in contact with mucus membranes.
Non-critical devices, such as stethoscopes that come in
contact with intact skin.
Description of Reprocessing Process
Adequate reprocessing of reusable medical devices is a critically
important step in protecting patient safety. Reprocessing is intended
to remove blood, tissue, and other debris and to inactivate infectious
microbes to ensure that devices are safe for the next patient use.
Reprocessing can be both labor-intensive and time-consuming, because
most reusable medical devices require a specific reprocessing regimen.
In general, reprocessing reusable medical devices involves three
steps: initial decontamination and cleaning at the point of use;
transfer to the reprocessing work area where the device is thoroughly
cleaned; and, either low/intermediate disinfection, high-level
disinfection, or sterilization, depending on the intended use of the
device, its risk of infection transmission, and the materials from
which it is made. The device is then stored or routed back into use.
Many factors contribute to reprocessing difficulties, including
device complexity, absence of best practices, user error, and poor
instructions on how to reprocess. Manufacturers, healthcare facilities,
healthcare professionals, and FDA share responsibility for reducing the
risk of healthcare-associated infections (HAIs) from inadequately
reprocessed reusable medical devices. HAIs are infections caused by a
wide variety of common and unusual bacteria, fungi, and viruses during
the course of receiving medical care.
FDA Authority/Role
Under FDA labeling regulations, 21 CFR Part 801, a device must have
adequate directions for use. This includes instructions on how to
reprocess (i.e., clean and disinfect or sterilize) a reusable device to
ensure that it is effectively prepared for its clinical use. FDA
applies its unique position and expertise to reduce the risk of
infection from reusable medical devices by evaluating devices prior to
marketing, identifying device designs that facilitate proper
reprocessing, assuring that manufacturer instructions are clear, and
promoting collaboration among all stakeholders. FDA also works with
manufacturers to correct product problems associated with reprocessed
medical devices.
Manufacturer Role
Manufacturers should design their devices to minimize debris
retention, so they can be easily and effectively cleaned. Instructions
for reprocessing, included in product labeling, should be complete,
detailed, practical, and easy to understand. FDA expects manufacturers
to validate their reprocessing protocols using clinically relevant
soil, considering the internal components of the device, and using an
actual marker(s) (a measured component of the soil, such as protein,
inorganic carbon, etc.) for clean under-simulated use conditions and
worst-case scenarios.
Healthcare Facility and Provider Roles
Healthcare institutions and staff and medical personnel share
responsibility for preventing problems associated with reprocessing.
Facilities should periodically assess infection control practices in
clinical areas using audit tools. Facilities should also ensure that
those responsible for reprocessing understand the importance of the
job, are given the necessary training to perform it properly, and
maintain proficiency in performing reprocessing for each type of device
they reprocess. Reprocessing staff should understand that pre-cleaning,
cleaning, high-level disinfection, and/or sterilization are distinct
and separate steps of reprocessing and that they should follow
reprocessing instructions provided by device manufacturers.
Physicians and nurses should consider that reprocessing plays a
role in device performance and follow-up with the appropriate chain of
accountability. They can do this by reporting adverse events that may
be related to inadequate reprocessing, following guidelines established
by professional societies, and communicating with manufacturers
regarding labeling issues and ease of reprocessing.
Challenges
Based on adverse event reports received, FDA has identified several
safety concerns with reprocessed medical equipment. For example, in a
review of adverse event reports on endoscopes filed with the Agency
from January 1, 2007, to May 11, 2010, FDA identified 80 reports of
inadequate reprocessing and 28 reports of infection that may have
occurred from inadequate reprocessing. Endoscopes are long thin tubes
with a camera or a light that are threaded into the lungs, the blood
vessels, or other cavities to visualize areas within the body. The
designs of endoscopes are intricate and complex, making optimal
cleaning, high-level disinfection, or sterilization difficult. It is
important to note, however, that endoscopes are used in over 10 million
medical procedures per year. While it appears that the risk of
acquiring such an infection is relatively low and that the benefits of
these important devices outweigh their risks, we continue to work with
industry, provider and government partners to further reduce risks to
patients.
Additional challenges to adequate reprocessing of reusable devices
include the detailed, labor-intensive, and time-consuming nature of the
necessary processes and the fact that each reusable medical device
requires specific reprocessing steps or techniques appropriate for that
device. While manufacturers are required to validate their reprocessing
instructions by documenting that the recommended cleaning,
disinfection, or sterilization process consistently results in an
adequately reprocessed device, many manufacturers do not use a
clinically relevant test soil in the validation testing of their
cleaning instructions for use, nor do they use an adequate marker for
the removal of soil. Finally, facility reprocessing challenges, such as
inadequate staff training and failure to consistently follow
reprocessing procedures, have been noted.
FDA's Work With the VA and CDC
The VA and FDA have a Memorandum of Understanding in place which
allows for timely information sharing to enhance knowledge and
efficiency between the Federal partners. Within FDA, CDRH has
designated a liaison that the VA may contact at any time regarding
questions or concerns on any topic. With regard to reprocessing,
beginning in 2008, the VA and FDA have collaborated to address concerns
regarding reprocessing of reusable medical devices and cross-
contamination of endoscopes during reprocessing. The Agency has
provided labeling and general information on FDA regulations and
participated in the VA conference entitled ``Reprocessing of Reusable
Medical Equipment: Using a Team Approach Towards a Strategic Plan,''
December 9-11, 2009.
Further, on November 19, 2009, the VA, CDC, and FDA issued a joint
safety communication regarding endoscope reprocessing, cautioning
healthcare facilities, including hospitals, ambulatory care facilities,
and private practices, about the risks to patients of improperly
processed flexible endoscopes and their accessories and recommended
steps to reduce these risks.
The VA has developed and shares with FDA information from its
national electronic Cardiovascular Assessment Reporting and Tracking
System (CART-CL), a network of approximately 70 cardiac catheterization
labs. FDA staff reviews this information with VA on a monthly basis,
and triages for appropriate further actions. Ongoing communication
benefits both parties, with FDA learning of unexpected lab-based
experiences, and CART-CL learning about FDA recalls and public health
communications.
CDC and FDA communicate quite frequently on matters related to
general infection control and to coordinate on the approval of some
respiratory devices. FDA has an ex-officio member on CDC's Healthcare
Infection Control Practices Advisory Committee. CDC has an official
liaison stationed at FDA, and there are regular interagency
teleconferences with CDC, FDA and EPA to discuss liquid chemical
germicides, high- level disinfectants and various aspects of
reprocessing of mutual interest to all three agencies.
Actions FDA is Taking
Adequately reprocessing reusable medical devices is a critically
important step in protecting patient safety. FDA is taking a
collaborative approach toward improving the reprocessing of reusable
medical devices. On April 29, 2011, FDA launched the Reusable Medical
Devices Improvement Initiative to reduce the risk of HAIs from
inadequately reprocessed medical devices. FDA's approach to addressing
reprocessing problems focuses on collaborating with other government
agencies, manufacturers, healthcare facilities, and healthcare
professionals to strengthen all steps in reusable device reprocessing
by fostering improved, innovative device designs to reduce debris
retention, strengthening the science of cleaning and high-level
disinfection or sterilization of medical devices, and ensuring that
healthcare facilities properly perform cleaning, disinfecting, and
sterilization.
Specifically, FDA has issued revised draft guidance that updates
and clarifies the recommended content of, and review procedures for,
medical device applications concerning the labeling instructions for
reprocessing reusable medical devices. In addition, this draft document
provides more detail about FDA's recommendations for the validation of
processes intended to support reprocessing. We have also announced a
public meeting to be held on June 8-9, 2011, to discuss factors
affecting the reprocessing of reusable medical devices and FDA's plans
to address the identified issues. Finally, FDA has developed a webpage
that provides general outreach about reprocessing of reusable medical
devices, the challenges of reprocessing, actions FDA is taking to
improve safety and effectiveness, and steps consumers and healthcare
professionals can take to learn more about reprocessing reusable
medical devices and reporting problems to FDA.
Goals of These Actions
The Reusable Medical Devices Improvement Initiative focuses on
improvements in device design, reprocessing procedures and protocols,
and healthcare facility quality assurance practices. This initiative
will promote innovation in next-generation reusable medical device
design that will make medical devices easier to clean, disinfect, and
sterilize, advance the science of cleaning and cleaning validation
methods, foster healthcare facility reprocessing quality assurance
programs, and share best practices.
The Public Meeting will bring together key stakeholders including
industry, user facilities, standards organizations, healthcare
accreditation organizations, government agencies, and professional
societies the first in a series of conversations between FDA and
reusable medical device stakeholders.
Conclusion
Reducing the risk of infection from reusable medical devices is a
shared responsibility, and one that the FDA takes very seriously. By
using its unique vantage point, FDA is helping address unacceptable
patient safety problems with reprocessed devices while facilitating
improvements in innovative design of the next generation of these
devices. Mr. Chairman, this concludes my formal statement. I will be
happy to address any questions you may have.
MATERIAL SUBMITTED FOR THE RECORD
Committee on Veterans' Affairs
Washington, DC.
May 12, 2011
The Honorable Eric K. Shinseki
The Secretary
U.S. Department of Veterans Affairs
Washington, DC 20420
Dear Secretary Shinseki:
In reference to our Full Committee hearing entitled ``Sacred
Obligation: Restoring Veteran Trust and Patient Safety,'' that took
place on May 3, 2011, I would appreciate it if you could answer the
enclosed hearing questions by the close of business on June 24, 2011.
In an effort to reduce printing costs, the Committee on Veterans'
Affairs, in cooperation with the Joint Committee on Printing, is
implementing some formatting changes for materials for all full
Committee and Subcommittee hearings. Therefore, it would be appreciated
if you could provide your answers consecutively and single-spaced. In
addition, please restate the question in its entirety before the
answer.
Due to the delay in receiving mail, please provide your response to
Debbie Smith by fax at 202-225-2034. If you have any questions, please
call 202-225-9756.
Sincerely,
BOB FILNER
Ranking Democratic Member
CW:ds
__________
The Honorable Bob Filner
Ranking Democratic Member
House Committee on Veterans' Affairs
Hearing on Sacred Obligation: Restoring Veteran Trust and Patient
Safety
May 3, 2011
Question 1: Dr. Petzel, would you agree that there is a problem
within the Veterans Health Administration with compliance of
established protocols, policies and procedures? If so, what are you
doing about it?
Response: Yes, there are challenges in ensuring 100 percent
compliance with established policies across 152 medical centers, 798
community based outpatient clinics, and 313,539 employees. Because this
is such an important issue, I, as Under Secretary for Health, have
undertaken a realignment of the Veterans Health Administration (VHA).
Clinical elements previously focused only policy development have been
moved into the Deputy Under Secretary for Health for Operations and
Management (DUSHOM) Operations and Management section. This realignment
provides clinical leaders who will: better ensure compliance with
existing policies; improve compliance mechanisms in future policies;
and improve accountability, with a direct link to the Veterans
Integrated Service Network operational structure and the ability to
directly influence practices and clinical outcomes.
These clinical leads will develop a dashboard, or set of metrics,
in the areas of homelessness, primary care, mental health, dental,
surgical services, geriatrics and extended care, sterile processing
department (SPD), disability management, and rural health operations.
These dashboards allow the DUSHOM to better monitor the quality of care
provided at the field level. For example, we are aggressively
inspecting SPDs (a total of 9 per year per facility), and are
consolidating inspection data to track policy compliance in several key
areas. Facilities with problems identified through inspections must
submit remediation plans that are tracked through completion by VA's
national SPD office.
Additionally, VHA oversight functions have been consolidated under
the Principal Deputy Under Secretary for Health (PDUSH). This will
serve to align and reconcile results of internal and external reviews,
with VHA performance metrics and performance results within a single
entity allowing for clear identification of outliers and improvements.
Under the leadership of the PDUSH and DUSHOM, operations and management
leaders will work closely with a new VHA Quality, Safety, and Value
(QSV) program office to ensure policy compliance and oversight is
improved. QSV will increase senior leader accountability for the
quality of clinical programs as well as the quality of VHA oversight of
those clinical programs. The Clinical Consultation and Compliance
program within QSV is tasked with implementing an International
Organization for Standardization (ISO) 9001-consistent Quality
Management System (QMS) in VHA, beginning with SPD.
ISO 9001 is the internationally recognized standard for the quality
management of businesses. It applies to the processes that create and
control the products and services an organization supplies. This
approach prescribes systematic control of activities to ensure that the
needs and expectations of customers are met. This method is designed
and intended to apply to virtually any product or service, made by any
process anywhere in the world. The ISO 9001 tools are widely recognized
as a best practice approach to hardwire continuous quality improvement
into organizational structures. I believe this approach will move VHA
forward in reaching our shared goals for improvements in the VA
healthcare system.
Question 2: It is clear to me that more attention needs to be
brought upon managers within the system who are accountable for
ensuring that policies are in place, enforced and reinforced and that
the management of personnel who are entrusted with carrying out the
policies needs to be bolstered. People need to be held accountable at
every level for not doing the right thing. When you have a Service
Chief who does not do ANYTHING about the behavior of practicing
dentist, even though he had been informed that infectious control
protocols were being completely ignored, indicates to me a glaring
weakness in leadership principles.
Question 2(a): How can behavior such as that [of the dentist in
question in Dayton] go unnoticed for as long as it did when multiple
staff members knew what was going on?
Response: This error was one of leadership--a failure on the part
of the service chief to act in response to employee complaints.
Inadequate leadership by the dental service chief created an atmosphere
in the dental clinic that discouraged individual employee
responsibility and accountability. The employees failed to go above the
service chief to make the medical center director or others aware of
the issue. Given the number and frequency of physical reviews and
inspections of the dental clinic by individuals from other departments
at the Dayton VAMC, employees from other VHA facilities, and
organizations external to VHA, I, as Under Secretary for Health, was
greatly disappointed to learn that the dental clinic issues were not
reported earlier. As a side note, a large number of VHA employees are
also veterans who receive care at their place of employment. These
employees represent the full range of healthcare professional and
support occupations, and are trained in VHA's expectations for
infection control and customer service. VHA did not receive complaints
from our non-dental service employees who received dental services.
During the week of May 2-5, 2011 a Management Review Team conducted
an on-site Management Program Review at the dental clinic as requested
by the DUSHOM. This team was comprised of seasoned current and former
VHA executives. Among many issues reviewed in detail were the length of
time the unacceptable practices continued and the failure to correct
those practices. The team report offered 11 recommendations for
improvement across many program areas. These recommendations are under
final review and action plans have been developed to implement them .
Again, while this situation occurred primarily due to a failure of
leadership by the former service chief, it was determined that
improvement actions were needed in other program areas such as quality
management, organizational development, and patient safety.
Question 2(b): Why do you think other staff members did not come
forward when nothing was done about the dentist's behavior?
Response: Cultural and other environmental factors may have
contributed to staff members not reporting. However, despite concerns
regarding the impact of making such a complaint on their career, or
about retaliation from the dentist in question or the former service
chief, VHA employees have various means of reporting complaints or
concerns. These include reporting through the Office of the Inspector
General (OIG), Office of the Medical Inspector, or to Infection Control
or Patient Safety. Additionally, the System-wide Ongoing Assessment and
Review Strategy (SOARS) program, The Joint Commission, and OIG had
visited the facility on multiple occasions before discovery of this
unacceptable practice. Dental employees could have approached those
individuals at any time to make them aware of these issues.
The VHA National Center for Organizational Development (NCOD)
offers organizational assessment and consultation services to VHA
organizations nationwide. NCOD assists with the design, administration,
and feedback provision of the VHA All Employee Survey. NCOD also
maintains an active research arm focused on organizational outcomes.
Approximately 1 year prior to discovery of the practices of the
dentist-in-question, NCOD had been engaged by Dayton VAMC to review and
assess outlier employee satisfaction scores identified at the dental
clinic via the nationally administered All Employee Survey. Since the
discovery of issues at the dental clinic, NCOD has conducted onsite
programs in the dental clinic to help clarify organizational climate
and environmental issues. NCOD is available to provide training,
coaching, and other assistance to individual leaders, managers, and
supervisors in all programs and departments at the Dayton VAMC.
Although this report is still being reviewed, of the
recommendations in the Management Review Team Report, three encompass
organizational climate and development issues: specifically executive
team building; development of soft skills across the organization; and
executive leadership transition. NCOD will provide additional
consultation in these areas and actions are underway to identify
seasoned VHA leaders to provide additional coaching and consultation as
action plans are developed to move forward to address the
recommendations made by the review team.
Additionally, the situation in the dental clinic has been used as a
teachable moment in a variety of meetings with Dayton VAMC staff, in
particular the obligation and requirement to report instances of
improper infection control and substandard patient care, to pursue
those reports further if action is not taken to address identified
issues, and to identify methods such reporting can be accomplished
either anonymously or by self identification. This was specifically
addressed during the stand-down period held in the dental clinic, where
the dental clinic was temporarily closed to allow for staff retraining.
Question 2(c): Is the leadership team not accessible to the front-
line worker?
Response: We have no evidence that any employee from the dental
clinic ever attempted to bring their concerns to the leadership team
and were turned away, or prevented from doing so. No member of the
dental clinic staff interviewed stated that they had made any effort to
contact the leadership team.
The senior leadership team at any VA Medical Center is accessible
to staff by several means, including scheduled committee meetings,
special hospital wide programs and celebrations, visits to various work
areas, and facility assessment walk throughs. In addition, all senior
leadership team members are accessible by email, as they are included
in the e-mail directory at each location.
A number of reviews of the dental clinic were conducted prior to
the discovery of practices of the dentist in question. Among these were
semi-annual physical environmental inspections conducted by a large
multi disciplinary team from other Dayton VAMC departments and led by
the Associate Medical Center Director. During these environmental
rounds, extensive discussions take place between team members and
employees in the area undergoing inspection. These discussions take
place simultaneously in the various work areas under review. It would
not have been possible for the former service chief to monitor or
control in any way all related interactions or discussions. The
practices of the dentist in question were not identified during these
physical inspections of the dental clinic.
At the Dayton VAMC, suggestion boxes are placed at multiple
locations across the Dayton campus to allow for employees, patients and
visitors to communicate directly with the senior leadership team. This
approach allows for anonymous participation. The former Medical Center
Director conducted quarterly all employee town hall meetings where any
employee had the opportunity to raise issues and/or ask him questions
directly.
Presently, the Acting Medical Center Director has a well-publicized
open door policy allowing for any employee to drop by unscheduled, to
discuss any issue. He is frequently out in the medical center on
unannounced ``walkabouts'' to seek out and engage employees. A formal
ambassador program has been created for senior leaders where senior
leaders all are scheduled for well-publicized informal engagement
sessions in the main hospital lobby and accessible to employees,
veterans, and visitors. A new working group has been established that
includes Veteran Service Organization (VSO) and elected officials
representatives, to share information collaboratively and specifically
identify stakeholder issues and concerns. Finally, the Acting Medical
Center Director is making personal visits to individual VSO posts
across the Dayton VAMC service area.
Question 3: Please explain to the Committee how long the external
peer review program has been in place and how often they look at cases
for each facility to assess the care provided?
Question 3(a): What, as a manager, do you do with those reports?
Question 3(b): The Veterans Integrated Service Network Directors
are very senior employees, how do these reports affect them?
Response: The national external peer review contract was awarded on
September 30, 2009 and was implemented during FY 10. The external
reviews consist of audit reviews and facility requested peer reviews.
The audit reviews serve to assess inter-rater reliability on peer
reviews completed by facility staff as well as validate our local
process. Facility requested peer reviews are conducted when there is
not enough clinical depth in a particular specialty to obtain a peer
review, when a senior level provider, such as a service chief, is under
review, or when facility leadership determines an independent outside
review is warranted.
All VA facilities are required to submit cases once per quarter for
audit review. The large tertiary care facilities (complexity 1a and 1b)
submit 15 cases/quarter; the smaller facilities (complexity 1c, 2, and
3) submit 10 cases/quarter. As of May 20, 2011, 281 facilities
requested reviews and 1,785 audit reviews have been completed. The
completed external peer reviews have a secondary review by clinical
staff in the Office of Quality and Safety (OQS). Any clinical concerns
are brought to the attention of the VISN Chief Medical Officer, VISN
Quality Management Officer, facility Chief of Staff, and the facility
Quality Manager or Risk Manager. Teleconference calls are scheduled
with OQS staff, medical experts from the contractor, VISN, and medical
staff to discuss cases when an opportunity for performance improvement
is identified. The external peer review program is contributing to our
ongoing mission to provide high quality care to our veteran population.
Question 4: What qualities and skills does VHA look at when
considering a selection for a VA Medical Center Director?
Response: Any Medical Center Director candidate must have a broad
and in-depth knowledge of healthcare systems. They must be able to
analyze complex issues, identify steps to resolve problems or implement
policy, evaluate outcomes and take corrective action where indicated.
They must have strong leadership skills to responsibly and effectively
triage clinical and management issues as they arise. Sound judgment is
paramount and must foster an environment of professionalism, optimism,
honesty, integrity, commitment to quality, continuous learning and
candor. The candidate must have a strong sense of duty, honor and
commitment to provide the highest quality of healthcare to those who
have served our country. Potential candidates are required to have
demonstrated hands-on healthcare operations experience, professional
board certification and continuing education are used to ascertain an
individual's commitment to maintaining and advancing one's personal
skill set, and a proven record of significant prior accomplishments is
required.
Question 5: What are the actions taken with facility management and
leadership when the VA Inspector General repeatedly finds problems at a
facility?
Response: VA leadership assesses each case and takes appropriate
personnel actions when indicated. A broad range of actions may be
considered ranging from the development of remediation plans to
disciplinary action depending on the nature and severity of the issue.
Issue-specific action plans may also be developed by the facility to
address identified issues. These are approved by the VISN and the OIG
and implementation is then monitored at the facility and VISN level.
Question 6: Both the Inspector General and the Government
Accountability Office have stated in separate reports that patient
safety is at risk due to leadership failures and weaknesses in policies
and oversight.
Question 6(a): What are you doing to improve leadership quality and
management training?
Response: As stated previously, a VHA reorganization is being
implemented at the highest levels of VHA to ensure appropriate
resources are aligned to accomplish the improvements needed. NCOD as
described previously, is a nationwide resource, that is actively
engaged across the VHA system to help identify improvement
opportunities and provides the tools and support necessary to achieve
improvements.
Additional actions have been taken by the National Center for
Patient Safety (NCPS). NCPS provides patient safety training programs
geared toward improving communication and hand-offs for facility staff
and leadership including: Medical Team Training (MTT), and Clinical
Crew Resource Management (CCRM). Specifically in regards to infection
control and re-useable medical equipment, training modules and tools
related to supply/equipment reprocessing resulting from joint work have
been shared with facilities, Networks and VHA Central Office leadership
and staff. These include: a series of core lessons learned from
reprocessing investigations completed in late 2010 (Attachment A); a
nationwide Healthcare Failure Mode and Effects Analysis (HFMEA) project
completed in 2007 (Attachment B); and, a presentation at the national
Network and Facility leadership meeting ``Preventing Infection is
Everyone's Job'' in early 2011.
__________
NCPS Lessons Learned--Reusable Medical Equipment in VHA
Lori A. King, Biomedical Engineer, NCPS
The National Center for Patient Safety (NCPS) has been involved in
many investigations involving set-up, use, and reprocessing of reusable
medical equipment (RME) over the last few years. We have issued Patient
Safety Alerts and Advisories on some of these topics. The two most
well-known VHA Patient Safety Alerts on the subject are the following:
Patient Safety Alert AL06-11, issued on April 3, 2006,
dealt with transrectal ultrasound transducers used for prostate
biopsies (http://www.patientsafety.gov/alerts/B-
KMedicalTransducerAlert06-011.pdf). The facility reported soiled needle
guides and later learned that brushes had not been used to clean the
lumens of the needle guides. Patients from several medical centers
required notification and follow up testing (for HIV, Hep C, and Hep
B), resulting in the largest look back/notification in VHA's history.
Patient Safety Alert AL09-07, issued on December 22,
2008, discussed improper setup and reprocessing of endoscopic
irrigation accessories (http://www.patient safety.gov/alerts/
OlympusScopesAlertAL09-07-WWW.pdf). This Alert also required patient
notification for some facilities and prompted VHA to look at all of the
reprocessing of RME in VHA facilities.
With all of the additional attention provided nationally to
reprocessing since December 2008, numerous issues with set-up, use, and
reprocessing of RME have been reported from VHA facilities via Issue
Briefs up through their VISN Offices to Central Office. Additional
issues have been identified in Office of the Inspector General Combined
Assessment Program (OIG-CAP) reports, System-wide Ongoing Assessment
and Review Strategy (SOARS) reports, and other investigations.
From involvement in many of these investigations we have identified
causative factors that have contributed to the potential for risk to
patients. The risk factors are outlined below along with suggestions
that facilities can put in place to mitigate the risks. The risk
factors and suggestions are listed in no particular order; all are
important to protect our veterans from potential harm.
By providing an environment where staff feel protected to report
discrepancies, without fear of retribution or discipline, we encourage
such issues to come to light and they (along with suggestions for
mitigating the risks) can be shared nationally to ensure we are
providing the best care for our veterans.
Attachment A
------------------------------------------------------------------------
Suggestion to
Risk Factor Mitigate Risk
------------------------------------------------------------------------
Reprocessing devices and device accessories in a
manner inconsistent with manufacturer's instructions
(i.e., not following the manufacturer's instructions
step by step or omitting steps).
Some examples:
Devices and device accessories not fully
disassembled before reprocessing
Follow the
Devices not sufficiently cleaned prior to manufacturer's
disinfection or sterilization (e.g., neglecting to instructions
brush lumens or channels; failing to fully submerge a for
device that requires full submersion into the reprocessing--e
cleaning solution) xactly, step by
step.
------------------------------------------------------------------------
Use of reprocessing agents not approved by
the manufacturer (e.g., use of hand soap instead of
an enzymatic cleaner; use of alcohol or sterilizing
wipes instead of high level disinfection or
sterilization)
Do not rely on
Devices not high level disinfected or verbal or
sterilized (e.g., not using the sterilization emailed
parameters set forth by the manufacturer's instructions
instructions; cleaning but not high level from
disinfecting or sterilizing) manufacturers.
Follow official
guidance from
the
manufacturer
(e.g.,
information
obtained from
the
Instructions
for Use,
Reprocessing
Guides, Company
Brochures,
Memorandum on
company letter
head, etc.).
------------------------------------------------------------------------
Manufacturer's set up and/or use instructions not
followed
Some examples:
Not priming endoscope irrigation systems
prior to insertion into patient
Staff ``rigging'' or ``making do'' with
defective devices or devices missing parts such that
procedures don't get canceled
Follow the
Multiple patient use of single use devices manufacturer's
instructions
for set-up and
use--exactly,
step by step.
------------------------------------------------------------------------
Purchase devices
and systems
with built-in
fault
tolerance,
where possible,
making it
harder for
users to make
mistakes in set
up or
operation.
------------------------------------------------------------------------
Inappropriately trained staff Ensure that
there are an
adequate number
of trained
staff and
supervisors at
all times in
SPD to meet
their mission
and
responsibilitie
s.
------------------------------------------------------------------------
Use of reusable devices that are difficult to clean Where possible,
properly, by design, even when the manufacturer's purchase and
instructions are followed (e.g., certain graspers, use disposable
Kerrison Rongeurs, suction tips, dental burrs) or ``take apart
devices'' for
hard to
reprocess
items.
------------------------------------------------------------------------
Staff not wanting to surrender instruments to SPD for Have the
reprocessing for fear of loss or damage to devices department work
closely with
SPD and ensure
SPD staff is
properly
trained to
handle and
reprocess the
department's
delicate
devices.
------------------------------------------------------------------------
Not reprocessing a reusable device according to the Reprocess the
original equipment manufacturer's instructions once a device
protective sheath has been removed (e.g., removing according to
the sheath and then using sterilizing wipes followed the original
by application of another sheath) equipment
manufacturer's
instructions
after each use--
even if a
protective
sheath was used
on the device
during the
procedure.
------------------------------------------------------------------------
Unclear terminology and/or lack of clear reprocessing Don't make
instructions from the manufacturer and subsequent assumptions if
assumptions made by staff a
manufacturer's
instructions
are unclear or
non-existent.
Get
clarification
in writing (in
a manner more
official than
email) from the
supplier. If
this proves
impossible,
contact the
National SPD
Office at 513-
487-6030.
------------------------------------------------------------------------
Lack of communication/acceptable hand off between Ensure staff
staff in SPD (and other areas reprocessing RME) and communicate
subsequent assumptions made (e.g., a staff member what step they
hands off the process to another staff member, are at in the
without indicating where they are in the process) reprocessing
process when
they hand off
the process to
another staff
member. If the
staff member
receiving the
hand off is
unsure of any
details after
the hand off,
they should err
on the side of
caution (i.e.,
assume that
nothing has
been done on
the device and
start from the
beginning).
------------------------------------------------------------------------
Use of inappropriate storage containers for dirty Use appropriate
devices (e.g., using sterilization bags to store and storage
transport dirty items) and use of inappropriate containers for
storage containers for reprocessed devices (e.g., dirty and clean
using reprocessing cassettes, use of foam-backed devices.
transport containers)
------------------------------------------------------------------------
Reprocessing occurring in peripheral locations (e.g., Consolidate
Dental, Eye Clinic, GI, Urology, Radiology, etc) and reprocessing to
oversight staff not knowing that reprocessing was SPD if at all
going on in the peripheral areas possible. If
not possible,
include audits
of all areas
outside of SPD
(e.g., Dental,
GI, Eye Clinic,
GI, Urology,
Radiology,
etc).
------------------------------------------------------------------------
Not being cognizant of different reprocessing steps Finding
done on the same device used in different areas of different
the facility (e.g., laryngoscope blades sterilized reprocessing
for the OR but high level disinfected for other areas processes
of the facility--when the manufacturer instructions existing with
indicate to sterilize) the same model
of device
should raise a
red flag to be
investigated.
Note however
that sometimes
it is perfectly
acceptable that
the same device
can be
reprocessed
differently
depending on
area used in
the facility--
that is,
provided the
manufacturer's
instructions
indicate it can
be reprocessed
in these
manners and the
areas where the
devices will be
used can accept
the level of
reprocessing.
------------------------------------------------------------------------
Human factors/systems issues with devices and
automatic reprocessors
Some examples: Not using the appropriate automatic
reprocessor
Ensure staff has
Not using appropriate connections with the been properly
automated reprocessor trained on the
use and
function of any
automatic
reprocessor
they use. ------------------------------------------------------------------------
Staff not following facility policy/protocol or lack
of policy/protocolSome examples: Use of equipment prior to having the
approval to use it Physician bringing in his/her own device
(e.g., intubation device) and reprocessing it (often
inappropriately) Damaged scope (to be sent for repair) used
on patient Loaner instruments cleaned but not
sterilized
Put in place the
Loaner instruments not being reprocessed proper policies/
prior to use (e.g., delivered from the vendor to the protocols to
OR instead of SPD) ensure the
examples shown
to the left
will not occur
at your
facility. ------------------------------------------------------------------------
A special thanks to the staff at VHA facilities and VISNs, as this
document would not be possible without their commitment to patient
safety and their diligence in discovering issues and bringing them to
light. Special thanks also to Sherri Bull and Rosie Fardo from the
National SPD Office for their thorough review of this document.
__________
Attachment B
2007 Healthcare Failure Mode and Effect Analysis (HFMEA) on
Supply Processing and Distribution (SPD) Topics
Topics/Processes
1. The process of reprocessing a flexible cystoscope between
patients including transportation, decontamination, high level
disinfection, sterilization and storage.
2. The process of reprocessing a flexible colonscope between
patients including transportation, decontamination, high level
disinfection, sterilization and storage.
3. The process of reprocessing a flexible bronchoscope between
patients including transportation, decontamination, high level
disinfection, sterilization and storage.
4. The process of reprocessing a flexible
esophagogastroduodenoscope (EGD) between patients including
transportation, decontamination, high level disinfection, sterilization
and storage.
5. The process of reprocessing a rigid endoscope used in urology
between patients including transportation, decontamination, high level
disinfection, sterilization and storage.
6. The process of reprocessing a rigid endoscope used in ENT
between patients including transportation, decontamination, high level
disinfection, sterilization and storage.
7. The process of reprocessing reusable items used to perform a
transrectal prostate biopsy between patients including transportation,
decontamination, high level disinfection, sterilization and storage.
8. The process of assuring sterility of orthopedic implantable
devices that come in orthopedic loaner instrument trays.
9. The process of communicating positive biological test results
from steam, EtO, and plasma sterilizers to the Chief of Staff, Chief of
Surgical Service, Operating Room Supervisor and Infection Control.
10. The process of disinfecting an infusion pump after patient use
including transportation and storage.
11. The process of using a pre-vacuum steam sterilizer in SPD
including verifying testing (e.g. Bowie-Dick, biological), reviewing
printouts (to determine sterilization parameters were met, signature of
reviewer, content list (detailed enough to enable item[s] retrieval if
necessary) and documentation of all required aspects of sterilization
process.
12. The process of using the ethylene oxide (EtO) sterilizer
within SPD including verifying testing (biological), reviewing
printouts (parameters were met, content list, list of items), content
list (detailed enough to enable item(s) retrieval if necessary) and
documenting the results.
13. The process of using the plasma sterilizer within SPD
including verifying biological testing, reviewing printouts (to
determine sterilization parameters were met, signature of reviewer),
content list (detailed enough to enable item(s) retrieval, if
necessary) and documentation of all required aspects of the
sterilization process.
14. The process of using steam sterilization in Dental including
verifying biological testing (Bowie-Dick type test if using a pre-
vacuum sterilizer), reviewing printouts (to determine if sterilization
parameters were met, signature of reviewer), content list (detailed
enough to enable item(s) retrieval, if necessary), and documentation of
all required aspects of the sterilization process.
15. The process of decontaminating surgical instruments prior to
sterilization.
16. The process of preparing surgical instruments for
sterilization including preparing the surgical instrument trays (e.g.
inspecting for bioburden, checking for instrument usability, correct
instruments in correct trays) and packaging instruments.
17. The process of coordinating and communicating the availability
of needed equipment and supplies between the OR and SPD.
18. The process of maintaining the primary storage environment
including: monitoring room temperature, humidity, the number of air
exchanges per hour, pest control; maintaining the storage arrangement
(e.g. stock rotation, avoiding outdates); and maintaining cleanliness
for sterilized instrumentation, equipment and supplies in SPD.
19. The process of maintaining the secondary storage environment
in the operating room including: monitoring room temperature, humidity,
the number of air exchanges; pest control; storage arrangement, and
cleanliness for sterilized instrumentation, equipment and supplies.
20. The processes of using sterilizers for flash sterilization in
the operating room including monitoring the frequency of use,
biological testing, identification of the date and patient and the
item(s) flash sterilized, and reviewing printouts to verify
sterilization parameters are being met.
Topic 1
The process of reprocessing a flexible cystoscope between patients
including transportation, decontamination, high level disinfection,
sterilization and storage.
Number of reporting facilities: 8
------------------------------------------------------------------------
Potential failure modes, causes and vulnerabilities Proposed
identified: solutions:
------------------------------------------------------------------------
Untrained Personnel Provide
Scope not cleaned properly all staff with
Scope not cleaned as per manufacturer's a thorough
instructions education
Lack of standardized staff training Impleme
nt a mentoring
program that
matches new
employees with
seasoned
employees
Provide
specific
training on
procedures that
are more
difficult to
perform or
remember
Provide
cognitive aids
to reduce the
amount of
information
that SPD staff
must recall
from memory
Provide
training on
manufacturer's
procedure for
cleaning
Repeat
training
annually as
necessary
------------------------------------------------------------------------
Scope not placed in distinguishable container for Place
transport distinguishable
May result in damage to the scope containers in
Red containers not easily accessible easy access
Difficult to find areas and areas
where they are
used often------------------------------------------------------------------------Unable to notify SPD or bring scope to SPD when needed Designa
SPD not available te other staff
Off hours to transport as
Not enough staff per policy for
off hours scope
use
------------------------------------------------------------------------Frequent use of brush tends to damage bristles Use
Result in bioburden build up single use
Single use brushes used more than once brushes once
and throw away
when done ------------------------------------------------------------------------Personal Protective Equipment (PPE) is not donned for Place
cleaning procedure PPE in easy to
PPE is not available access ------------------------------------------------------------------------Scopes dry in a horizontal position that causes Purchas
pooling e a drying
cabinet with a
fan within
which scopes
can be hung
vertically
------------------------------------------------------------------------Proper protocol not followed due to lack of adequate Purchas
equipment e more
Not enough equipment equipment
Not the right equipment (e.g. wrong sized
brush can cause damage to the scope)
------------------------------------------------------------------------Scopes are not being processed at the highest level of Purchas
sterilization because there are not enough scopes to e more scopes
meet the caseload of the clinic to allow proper
sterilization
between
patients------------------------------------------------------------------------Using different sized sinks or wash basins can alter Limit
the cleaner to water ratio process to use
of a standard
basin only.
Ensure all
staff use the
correct basin------------------------------------------------------------------------
Topic 2
The process of reprocessing a flexible colonscope between patients
including transportation, decontamination, high level disinfection,
sterilization and storage.
Number of reporting facilities: 8
------------------------------------------------------------------------
Potential failure modes, causes and vulnerabilities Proposed
identified: solutions:
------------------------------------------------------------------------
Failure to disassemble endoscope before cleaning Use the
endoscope
manufacturer
provided
cognitive aids
showing the
cleaning
process will be
posted where
clearly visible
during the
cleaning of the
endoscope
If none
are available,
construct
cognitive aids
to provide to
staff
------------------------------------------------------------------------
Surgical residents performing endoscopic procedures Use
after hours and on weekends do not wipe down the signage to
scope with a detergent soaked sponge/cloth remind
immediately post procedure residents of
post-
operational
cleaning
Annual
staff education
on proper
maintenance
Purchas
e a cleaning
kit to be kept
bedside for the
surgeon to do
initial
cleaning of the
endoscope
Develop
a checklist/
instruction for
the immediate
pre and post
procedure care
of the
endoscope and
associated
equipment and
post it in the
appropriate
areas
------------------------------------------------------------------------
Personal Protective Equipment (PPE) not used regularly Provide
PPE in
locations near
where
reprocessing
takes place
Use
signage to
indicate where
and when to use
PPE
Be sure
to educate
staff on proper
use of PPE
------------------------------------------------------------------------
Endoscope does not dry properly, water pools in the Provide
endoscope a storage
Clean endoscope cabinet located in same cabinet that
area as contaminated endoscopes has adequate
ventilation and
is equipped to
store the
endoscopes
vertically
Flush
lumens with
alcohol and/or
air prior to
storage to
promote drying
Move
clean endoscope
cabinet to an
area without
contaminated
endoscopes
------------------------------------------------------------------------
Steps skipped when going through procedures of Post
cleaning and disinfecting (i.e. forgetting to flush signage of
lumens with alcohol) steps for
cleaning to jog
memory
Set up
room to promote
the proper
cleaning and
disinfecting
procedures
------------------------------------------------------------------------
Appropriate containers not used to transport See
contaminated endoscopes topic 4
Choose not to use container because it is ``Transportatio
only a short distance to decontamination area n''
Appropriate containers not available (i.e. Post
only open top containers available) signage
indicating that
contaminated
endoscopes must
always be
transported in
a closed top
container
Provide
more
appropriate
(i.e. closed
top) containers
for transport
of contaminated
endoscopes
Be sure
to place an
adequate amount
of the
containers in
areas they are
needed
------------------------------------------------------------------------
Water temperature not adequate for activating Install
enzymatic solution thermometers to
verify water
temperature
before using
the enzymatic
solution
------------------------------------------------------------------------
Not using adequate amount of solution when flushing Purchas
lumens with alcohol or other cleaning steps e measuring
containers that
will measure
and/or dispense
the exact
amount of
solution needed
when flushing
lumens or
otherwise
cleaning the
endoscopes------------------------------------------------------------------------Timing is not adequate for steps in the reprocessing Purchas
of endoscopes (i.e. soak time) e and install a
timer in the
appropriate
areas to use
when timing
reprocessing
steps
------------------------------------------------------------------------Endoscope not picked up from Operating Room (OR) in a Provide
timely manner SPD staff with
a means of
communication
(i.e. pagers)------------------------------------------------------------------------Results for each scope are not traceable to specific Staff
patients on whom a procedure was performed will record the
scope number in
the procedure
log
Create
a column in the
procedure log
that is used to
record the
endoscope
number for each
procedure on
each patient
Impleme
nt a barcode
system, coding
both the
patient's
wristband and
the endoscope------------------------------------------------------------------------Scopes which fail leak test may be reprocessed and Add to
used again on a patient the procedure
the process to
follow if a
leak test fails
All
scopes which
fail the leak
test either
before or after
the procedure
should have a
work order
placed and be
taken out of
service until
repaired------------------------------------------------------------------------Patient specific tracking not done Develop
and implement
patient
specific
tracking log
for all scopes------------------------------------------------------------------------
Topic 3
The process of reprocessing a flexible bronchoscope between patients
including transportation, decontamination, high level disinfection,
sterilization and storage.
Number of reporting facilities: 10
------------------------------------------------------------------------
Potential failure modes, causes and vulnerabilities Proposed
identified: solutions:
------------------------------------------------------------------------Transportation Set up
Lack of appropriate space to separate clean separate rooms
from dirty instruments/equipment for dirty and
Adequate container not available for clean
transport instruments/
equipment
Set up
the dirty room
so that it is a
negative air
flow room with
monitor checked
daily
See
Topic 4
``Transportatio
n''
Provide
an appropriate
transport
container that
is rigid and
properly
labeled (i.e.
biohazard)------------------------------------------------------------------------
Decontamination Post
Not performed correctly the cleaning
Lack of training checklist, use
Process not standardized as a cognitive
aid
Make
employees
accountable by
including the
employee's
identification
tag to
determine who
processed the
instruments
Maintai
n record log to
reflect serial
number of each
scope
reprocessed and
name of the
staff doing the
procedure
Require
annual training
for all staff
Develop
SOP for all
processes and
educate staff
------------------------------------------------------------------------
Cannot properly complete procedure because of lack of Purchas
supplies e adequate
supplies
Create
and utilize a
system to
report and
purchase needed
items
Bar
code area for
items needed------------------------------------------------------------------------
Staff unaware of correct brush to use to remove Purchas
bioburden e only
disposable
brushes
Educate
staff on which
brushes to use
to adequately
remove
bioburden
------------------------------------------------------------------------
Staff too busy to properly perform process Re-
write position
descriptions to
adequately
reflect the
need of the
hospital and
fill all vacant
positions
------------------------------------------------------------------------
Lack of appropriate pre-cleaning/Decontamination room Provide
and potential for contamination appropriate
space to
separate clean
from dirty
instruments/
equipment that
meets VA
directive 7176
requirements
Provide
a technician to
perform all
decontamination
procedures
------------------------------------------------------------------------
Disinfection of bronchoscope is performed in various Designa
areas making it difficult to monitor and ensure te one area
compliance with proper procedure where the whole
process of
disinfecting
the
bronchoscope
occurs
Require
disinfection of
brochoscopes to
occur in SPD------------------------------------------------------------------------
Proper concentration of enzymatic solution not used Place a
waterproof
label in the
sink to
indicate water
level needed
Purchas
e a container
that will
dispense the
amount of
enzymatic
solution needed
for that amount
of water (pump
bottle)
Or
purchase a
measuring
device for
obtaining the
correct amount
of enzymatic
solution
(measuring cup/
scoop)
------------------------------------------------------------------------
Improper sterilization Develop
a checklist
using
manufacturer's
recommendations
Direct
observation by
supervisor to
assure
compliance with
manufacturer's
checklist
------------------------------------------------------------------------
Scope not aspirated with alcohol, substituted with Educate
another solution staff on
alcohol use
Impleme
nt an initialed
log to identify
scope and
process steps------------------------------------------------------------------------Inappropriate storage Provide
Clean scopes left lying flat in clean separate areas
containers in dirty areas to accommodate
patient
procedure
decontamination
and storage of
instruments and
equipment in a
cabinet
Change
the procedure
to ensure that
scopes are hung
to dry after
reprocessing------------------------------------------------------------------------Failure to link scope and patient to processing cycle Use a
bar coding
system
Develop
a system that
tracks trays
and scopes to
patient and
process used
Number
the scopes and
keep a log that
links scope
number to
patient and
process------------------------------------------------------------------------
Topic 4
The process of reprocessing a flexible esophagogastroduodenoscope (EGD)
between patients including transportation, decontamination, high level
disinfection, sterilization and storage.
Number of reporting facilities: 6
------------------------------------------------------------------------
Potential failure modes, causes and vulnerabilities Proposed
identified: solutions:
------------------------------------------------------------------------
Transportation Develop a system
Uncertain which bin to use using different
Potential for mixing the rinsed soiled colored bins to
scope with the clean scope differentiate
Potential for wrong container to transport dirty and clean
from manual cleaner to Steris scopes
Potential for using wrong bin for delivery Purchas
of scope to end user e different
Scope could be transported incorrectly colored bins,
(e.g. on its knobs, coiled, twisted or double example:
stacked) Red
bins: Biohazard
and dirty
scopes
White
bins: Transport
from manual
cleaning to
Steris
Gray
bins: Clean
scope delivery
to end user
Educate
staff on the
need for proper
transportation
of these scopes
and the need to
transport all
equipment
correctly------------------------------------------------------------------------
Improper decontamination Have
reprocessing
manual
available for
GI and SPD
staff for
immediate
reference
during
reprocessing------------------------------------------------------------------------
Potential for using the wrong sized brush or not Keep an
having the appropriate brushes available ample supply of
appropriately
sized,
disposable
brushes------------------------------------------------------------------------
Potential for attaching the wrong cover to the Impleme
channels (i.e. different type of scope or different nt plastic
manufacturer) identifier card
using sturdy
chains
installed to
each connector
that identifies
type of scope
and
manufacturer
Impleme
nt bar coding
system if
possible------------------------------------------------------------------------
Scope is not wiped down immediately following Develop
procedure procedure for
nursing
supervisor and
ICU staff on
pre-cleaning
and handling
scopes
immediately
after a
procedure------------------------------------------------------------------------
Dried bioburden is not removed Compete
ncy for GI
nurses will
include details
on aspirating
detergent and
flushing air
through channel
Ensure
appropriate
brushes are
available for
removing
bioburden
Post
instructions as
to proper
removal of
bioburden
emphasizing
proper
technique------------------------------------------------------------------------
Failure to accomplish leak testing Monitor
Failure to deflect distal tip to check for number of wet
leakage tests related
to number of
scope
procedures
completed
Post a
detailed
sequence of
steps in view
of key staff
assigned to
reprocessing of
scopes with
demonstrated
competency
assessed
annually and as
changes occur
Monitor
number of tip
deflections
performed
related to
number of scope
procedures
performed------------------------------------------------------------------------
High level disinfection Write
SOP to provide
a standard of
practice on
processing
scopes using
high level
disinfection to
clean scopes on
clinical days
SOP
needs to be in
place to
provide
communication
with end users
on processing
of scopes to
use during high
level
disinfection------------------------------------------------------------------------
Biological results are positive, but are not Alter
communicated as such the process to
include running
biological
indicator at
the end of the
shift
Results
will be
available to
ensure next
morning's
workload begins
with an
operational
unit
Develop
means of
communicating
test status
between
microbiology
and endoscopy------------------------------------------------------------------------
Staff may not be aware to test the Steris system each Quality
day control book
should be
maintained to
ensure each
Steris machine
is checked for
diagnostics and
biologicals
daily during
regular tours
Educate
staff and post
signage near
the Steris
indicating
daily
procedures------------------------------------------------------------------------
All staff may not be aware of the minute details that Assign
should be completed for each cleaning of scopes key staff to
endoscope
cleaning
trained with a
detailed step
by step
process,
annually or as
changes occur
Create
a specialty
team for the
scope cleaning
process
------------------------------------------------------------------------
Storage Provide
a cabinet that
will allow
scopes to hang
to promote
proper drying
------------------------------------------------------------------------
Topic 5
The process of reprocessing a rigid endoscope used in urology between
patients including transportation, decontamination, high level
disinfection, sterilization and storage.
Number of reporting facilities: 8
------------------------------------------------------------------------
Potential failure modes, causes and vulnerabilities Proposed
identified: solutions:
------------------------------------------------------------------------
Transportation Purchas
Containers used for storage and e and implement
sterilization do not protect the scopes during appropriate
transportation containers to
Sterile instruments are transported on a protect the
dirty wire cart scopes during
Scope transported without a solid lid transportation
------------------------------------------------------------------------Variation in the concentration of the enzymatic Purchas
cleaner e a measuring
device to
select the
correct amount
of enzymatic
solution ------------------------------------------------------------------------Brushes being re-used Deconta
minate the
brushes daily ------------------------------------------------------------------------Scopes arrive at SPD with dried debris on them Impleme
nt use of
enzymatic
cleaner in a
spray bottle to
spray scopes
with after
procedures to
prevent dried
debris
------------------------------------------------------------------------Staff unaware that ultrasonic cleaner needs to be Place
changed often and needs enzymatic solution signage above
the ultrasonic
cleaner
regarding the
use of the
enzymatic
cleaning
solution and
the amount to
be used ------------------------------------------------------------------------
Variation in the scope cleaning process by SPD staff Standar
dize the
process by
implementing a
SOP
Educate
staff in SOP
Install
cognitive aids
indicating
appropriate
steps to take
during process
of cleaning
Be sure
to purchase
adequate
numbers of
scopes to allow
reprocessing in
SPD between
uses
Purchas
e adequate
amounts of
cleaning
supplies to
allow
appropriate
reprocessing
procedures
Create
a system such
as bar coding
to track the
scope to the
person who
cleaned it
------------------------------------------------------------------------
Washer/Disinfector machine's dry cycle does not dry Ensure
instruments that the
biomedical
engineer's
periodic
maintenance
includes drying
cycle checks
Ensure
SPD staff know
how to report
malfunctions
Add
malfunction
reports to
annual staff
training and
new employee
orientation
------------------------------------------------------------------------
Variations in scope cleaning process by SPD staff Establi
sh SOP and
include it in
new employee
orientation,
and annual
staff training
------------------------------------------------------------------------
Storage Store
Inadvertently placed soiled items on the all sterile
top of the cart where clean items are being stored supplies in a
There are environmental hazards such as sterile supply
cleaning materials or dust in the storage area room only
Evaluat
e for the
availability of
storage space
for clean items
in the OR rooms
so clean items
are not stored
on the top of
the case cart
during
procedures
Purchas
e closed
shelving units
for quarantined
items
Relocat
e current
shelving to
minimize the
contamination
of packages due
to
environmental
hazard
------------------------------------------------------------------------
Topic 6
The process of reprocessing a rigid endoscope used in ENT between
patients including transportation, decontamination, high level
disinfection, sterilization and storage.
Number of reporting facilities: 2
------------------------------------------------------------------------
Potential failure modes, causes and vulnerabilities Proposed
identified: solutions:
------------------------------------------------------------------------
Transportation Obtain
While transporting the scope to be cleaned, larger
it is broken containers to
Endoscope may not be used in an area where transport
biohazard bags are present, resulting in endoscopes scopes out of
not placed in biohazard bags room to the
area where they
are processed
Provide
biohazard bags
inside
transport case
to cover
contaminated
endoscope from
inpatient units
after use
Post in
the exam rooms
and outside of
the endoscope
transportation
case, signage
indicating that
used endoscopes
must be placed
in biohazard
bags
------------------------------------------------------------------------
Timing for disinfecting and cleaning steps is not Purchas
consistent e and install a
clock with a
second hand in
the work room
Purchas
e timers to
time endoscope
exposure to
enzymatic
detergent and
Cidex OPA
------------------------------------------------------------------------
Crucial steps in the cleaning process are omitted or Sterile
incomplete processing of
endoscopes
should be done
by SPD staff
who have
completed
required
training and
certification
as per VHA
directive 7176
Ensure
manual is
updated and
available
Provide
in-service by
vendor to all
who are
responsible for
cleaning the
endoscopes
Due to
tedious
process, rotate
SPD staff
through
different
duties during
the day
Impleme
nt a system for
accountability
using
identifying
tags, or a bar
coding system
------------------------------------------------------------------------
Personnel without validated VAMC competency initiate ENT
the high level disinfection process clinic staff,
ENT medical
staff and
rotating ENT
resident
rosters should
be reviewed for
competency
If not
competent,
schedule in-
service
training for
staff who need
it
Schedul
e in-service
training for
physicians and
residents as
well
------------------------------------------------------------------------
Storage cabinets are not labeled potentially causing Label
clean and dirty instruments to be mixed up clean storage
cabinets
``clean
endoscope''
Label
any container
that holds
dirty
instruments
``dirty
endoscope''
------------------------------------------------------------------------
Topic 7
The process of reprocessing reusable items used to perform a
transrectal prostate biopsy between patients including transportation,
decontamination, high level disinfection, sterilization and storage.
Number of reporting facilities: 7
------------------------------------------------------------------------
Potential failure modes, causes and vulnerabilities Proposed
identified: solutions:
------------------------------------------------------------------------
Power goes out: weather, earthquake, fire Resched
ule cases
Obtain
backup power
sources
Develop
a backup plan
to use other
facilities
------------------------------------------------------------------------
Nobody in SPD available to receive items (i.e. lumens) Hire
Staffing issues more staff or
Lack of communication process backup staff
Use an
end of shift
report, morning
and afternoon
reports and a
communication
board in a
prominent
location
------------------------------------------------------------------------
Items missing/left in urology procedure area or in the Urology
OR should assume
Items picked up by SPD staff inadvertently the
from the OR area responsibility
Items are thrown away after the case for items used
during OR
(operating
room)
procedures and
should perform
initial
cleaning prior
to delivering
items to SPD
decontamination
area
------------------------------------------------------------------------
Incorrect solution or ratio of enzymatic cleaning Identif
agent and water used for cleaning y correct
amount of
enzymatic
cleaning agent
purchasing
container that
dispense
correct amount
of cleaning
agent or using
other measuring
device (i.e.
cup) Post
this
information at
the
decontamination
sink to avoid
re-labeling
each new bottle
and to identify
the correct
solution Add
measurement
markers at 1
gallon
intervals to
act as a visual
aid for staff
when they fill
the sink with
water------------------------------------------------------------------------
Failure to follow the correct protocol when cleaning Educate
the instruments the staff in
the
standardized
processes
available for
instrument
maintenance Review
this
information
annually Post
visual aids and/
or memory
joggers to
assist staff------------------------------------------------------------------------
Contamination occurs during handling Establi
sh strict
standardized
procedure for
handling and
sterilization
of the prostate
needle guide
device. SPD
manual H90.1
guideline (ID/
SPD Note: this
should be the
VA Directive/
Handbook 7176)
will be
followed to
prevent
contamination
(e.g. end user
rinses the
dirty device
with tap SPD
picks up the
device the
device is
submerged in
cleaning
solution
external and
internal------------------------------------------------------------------------
Instruction not complete/correct For new
equipment/
devices
procedures/
instructions
are developed
using the
manufacturer's
guidelines.
Guidelines are
attached to the
new procedure------------------------------------------------------------------------
Failure to follow manufacturer's instructions Reduce
Staff is hurried and/or distracted distractions in
Staff was never informed of the the work area
instructions
------------------------------------------------------------------------
Brush Issues Establi