[Senate Hearing 111-177]
[From the U.S. Government Publishing Office]
S. Hrg. 111-177
HEARING ON OVERSIGHT OF VA QUALITY MANAGEMENT ACTIVITIES
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HEARING
BEFORE THE
COMMITTEE ON VETERANS' AFFAIRS
UNITED STATES SENATE
ONE HUNDRED ELEVENTH CONGRESS
FIRST SESSION
__________
JUNE 24, 2009
__________
Printed for the use of the Committee on Veterans' Affairs
Available via the World Wide Web: http://www.access.gpo.gov/congress/
senate
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COMMITTEE ON VETERANS' AFFAIRS
Daniel K. Akaka, Hawaii, Chairman
John D. Rockefeller IV, West Richard Burr, North Carolina,
Virginia Ranking Member
Patty Murray, Washington Lindsey O. Graham, South Carolina
Bernard Sanders, (I) Vermont Johnny Isakson, Georgia
Sherrod Brown, Ohio Roger F. Wicker, Mississippi
Jim Webb, Virginia Mike Johanns, Nebraska
Jon Tester, Montana
Mark Begich, Alaska
Roland W. Burris, Illinois
Arlen Specter, Pennsylvania
William E. Brew, Staff Director
Lupe Wissel, Republican Staff Director
C O N T E N T S
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June 24, 2009
SENATORS
Page
Akaka, Hon. Daniel K., Chairman, U.S. Senator from Hawaii........ 1
Burr, Hon. Richard, Ranking Member, U.S. Senator from North
Carolina....................................................... 1
Specter, Hon. Arlen, U.S. Senator from Pennsylvania.............. 3
Begich, Hon. Mark, U.S. Senator from Alaska...................... 4
Tester, Hon. Jon, U.S. Senator from Montana...................... 4
Isakson, Hon. Johnny, U.S. Senator from Georgia.................. 5
Johanns, Hon. Mike, U.S. Senator from Nebraska................... 20
WITNESSES
Nolan, Thomas, Ph.D., Senior Fellow, Institute for Healthcare
Improvement.................................................... 5
Prepared statement........................................... 7
Wise, Robert A., M.D., Vice President of Standards and Survey
Methods, The Joint Commission.................................. 9
Prepared statement........................................... 10
Watrous, Julie A., RN, MS, Director, Combined Assessment Program,
Office of Healthcare Inspections, Office of Inspector General,
U.S. Department of Veterans Affairs; accompanied by John D.
Daigh, M.D., Assistant Inspector General for Healthcare
Inspections; and Victoria H. Coates, Regional Director of the
Atlanta Office of Healthcare Inspections....................... 15
Prepared statement........................................... 17
Cross, Gerald M., M.D., FAAFP, Acting Under Secretary for Health,
Veterans Health Administration, U.S. Department of Veterans
Affairs; accompanied by Dr. William E. Duncan, M.D., Ph.D.,
MACP, Associate Deputy Under Secretary for Health for Quality
and Safety; Juan A. Morales, RN, MSN, Director, Tennessee
Valley Healthcare System; Rebecca J. Wiley, Director, Charlie
Norwood (Augusta) VA Medical Center; and Mary D. Berrocal, MBA,
Director, Miami VA Healthcare System........................... 34
Prepared statement........................................... 37
HEARING ON OVERSIGHT OF VA QUALITY MANAGEMENT ACTIVITIES
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WEDNESDAY, JUNE 24, 2009
U.S. Senate,
Committee on Veterans' Affairs,
Washington, DC.
The Committee met, pursuant to notice, at 9:31 a.m., in
room 418, Russell Senate Office Building, Hon. Daniel K. Akaka,
Chairman of the Committee, presiding.
Present: Senators Akaka, Tester, Begich, Specter, Burr,
Isakson, and Johanns.
OPENING STATEMENT OF HON. DANIEL K. AKAKA, CHAIRMAN,
U.S. SENATOR FROM HAWAII
Chairman Akaka. The hearing of the Senate Committee of
Veterans Affairs will come to order.
Let me say that we know of several instances of poor
quality care including the prostate cancer treatment in
Philadelphia. The deaths at Marion, Illinois, of course, and at
certain facilities which failed to clean endoscopes properly,
putting veterans at risk for infectious diseases.
In the case of the cancer treatment, VA contracted with an
outside entity for a large sum of money, with the expectation
that good care would be provided. Good care was not the result
and VA failed to monitor such care. I want to be clear that
each of these instances is a breach of our promise to provide
the highest quality of care to our veterans.
As I said I would keep my opening statement short, I would
like to call on our Ranking Member, Senator Burr, for his
opening statement.
STATEMENT OF HON. RICHARD BURR, RANKING MEMBER,
U.S. SENATOR FROM NORTH CAROLINA
Senator Burr. Thank you Mr. Chairman. Aloha.
Chairman Akaka. Thank you.
Senator Burr. Mr. Chairman, I want to thank you for
honoring my request from early May and calling what I think is
a vitally important hearing about the VA's improper cleaning of
its medical equipment. I want to welcome our witnesses today.
There is a human element to this issue that must not be
forgotten or overlooked at all. Those affected are all veterans
who served their country with honor.
These are people like Michael Priest, a Navy veteran who
had a colonoscopy performed at the Murfreesboro VA Medical
Center in June 2007. Mr. Priest was to submit a statement today
about his experience, though we haven't gotten it yet, Mr.
Chairman.
The VA notified Mr. Priest by telephone that he had tested
positive for Hepatitis B and HIV. After he came in for more
extensive tests and treatment, they notified him by phone a
week later that the first round of tests were inaccurate: he
was not infected.
The lack of sensitivity displayed by VA officials in Mr.
Priest's case is troubling, to say the least. There was no
formal apology issued to him, no phone call from a higher up
from the hospital explaining why there was a mix-up, just a
single phone call saying, ``We got it wrong,'' as if the detail
was trivial and not life-impacting. There was this and
clinicians informing his wife, who accompanied him for the
second test and was also presumed to be infected, that she was
on her own when looking for treatment, that the VA would not
necessarily facilitate for her.
Simply put, this is an unacceptable way to treat our
veterans or their families. Unlike Mr. Priest, who was
ultimately found to be negative for these diseases, 52 of his
fellow veterans have tested positive. While it is still unclear
if the procedures at VA facilities are responsible for
infection, what is clear is that VA's practices opened the door
to exposure.
Mr. Priest has abandoned the VA health system and is now
seeing a private provider. When veterans lose their confidence
in the VA, then we have all failed in our mission to care for
those who fought for us.
Although the VA has been working to restore confidence in
their services, veterans are still hesitant; and, quite
frankly, who can blame them? The more I learn about this issue,
the more it seems to be a case of extreme negligence.
With multiple past incidents, multiple warning signs,
multiple patient safety alerts, multiple internal VA
directives, widespread media attention, an on-going Inspector
General's investigation, and pending hearings on the issue,
there is no possible justification as to why this has still not
been corrected.
I am going to run through a brief timeline, Mr. Chairman.
March 2003. Patient Safety Advisory issued stated that the
auxiliary water channels on endoscopies must be cleaned after
each use. Again, March 2003. Despite this warning, this was not
followed in at least 18 facilities, including Murfreesboro and
Miami.
February 2004. Another alert, this time about using the
correct connectors. Despite this warning, incorrect connectors
were used in Murfreesboro.
Are you noticing a pattern here? I sure am. Since this 2004
February alert, there have been 11 additional Patient Safety
Alerts on the topic of medical devices and equipment
reprocessing. Eleven.
April 2006. Over 500 Maine veterans are tested due to
improper disinfection of biopsy needles. Seventeen facilities
in 11 States are found to have the same problem.
March 2008. 714 veterans at an Illinois facility put at
risk because of improper cleaning of biopsy valves. VA put out
a Patient Safety Alert in response.
July 2008. 159 veterans at a North Dakota facility put at
risk because of improper cleaning of the ENT endoscopies,
strikingly similar to the problem we saw at the Augusta Medical
Center.
As you can see, despite 6 years of warnings about improper
cleaning of medical devices, we now arrive at the current
problem that has all of our attention.
December 2008. In the wake of improper reprocessing at
Murfreesboro, another Patient Safety Alert issued. Again, not
new issues, but issues first brought out in 2003 and 2004.
February 2009. VA issues another directive, detailing the
proper procedures for the maintenance of equipment. The IG
report shows this was ignored by many facilities.
March 2009. VA conducts a ``Step-Up Week,'' in which,
according to a VA press release, VA would focus on
``retraining, accountability, and training of standard
operating procedures.'' The IG reports that this was also
ignored at many facilities.
Mr. Chairman, it is one thing for the VA to discover
problems at its facilities and disclose them. But that's only
one part of the equation. The other part is learning from
mistakes so they are not repeated. That did not happen. It has
not happened to date.
The IG conducted unannounced visit to a random sample of
hospitals on May 13 and 14, and in these visits, less than 50
percent of the facilities were able to prove they are doing
this right. Thirteen and 14 May. Still after all that has
happened to shed light on the proper way to do this, they are
still not doing it right.
In the wake of Murfreesboro, we were told that all
facilities were looking at their procedures and fixing any
problems that they had.
The VHA directive on February 9 was supposed to have
codified the procedures. The Step-Up Week in early March was
supposed to have engaged senior hospital management in
personally assuring that the procedures were being done right;
then came the IG's findings.
Mr. Chairman, the warning signs were there, but the
decision not to focus on them and to take corrective action is
what we cannot tolerate. That is the culture that must change.
I look forward to hearing from not only our first panel,
but our second panel of VA witnesses. I am not satisfied that
the larger problem of patient safety is being adequately
addressed. I hope to be convinced today--not for my sake, but
the safety of our veterans who trust this medical system as
their lifeline.
Mr. Chairman, thank you.
Chairman Akaka. Thank you very much Senator Burr.
And now I would like to call on our Member, Senator
Specter, for his brief statement.
STATEMENT OF HON. ARLEN SPECTER,
U.S. SENATOR FROM PENNSYLVANIA
Senator Specter. Thank you very much, Senator Akaka. Thank
you Mr. Chairman and Senator Burr for convening this hearing.
I want to speak briefly about a problem which is very
similar which has occurred at the Philadelphia Veterans
Administration Hospital. According to a New York Times article
last Sunday, a rogue cancer unit at the Philadelphia VA Medical
Center botched 92 of 116 cancer treatments over a span of more
than 6 years and kept quiet about it. Ninety-two implant errors
resulted from a system-wide failure in which the safeguards
were ignored.
The approach is to have seeds the size of a grain of rice
permanently inserted into the prostate through needles instead
of having an operation. And the insertions were to the wrong
area.
I very much appreciate, Mr. Chairman, your authorizing a
field hearing in Philadelphia, which we have scheduled for next
Monday. I regret that I cannot stay, as we have an
extraordinarily busy morning with the live quorum at 10 o'clock
and the vote at 11. I think, as most everyone knows, there are
many committees meeting simultaneously, so we have to be
quadruplets really to make all of the events. We have invited
Dr. Cross to come to Philadelphia and I hope he will join us at
that time.
I can't see all of the nameplates. Is Dr. Cross in the
room? Will you join us on Monday?
Dr. Cross. Sir, if you need me there I will be there. I
have a family wedding to go to, but if need be, I will skip it.
Senator Specter. Well, I very much appreciate your
willingness to accommodate our schedule. There's a tremendous
amount of concern in Philadelphia--really more broadly
speaking, but certainly in Philadelphia--where these implants
occurred and I think that prompt oversight is something that we
ought to do to respond to the public concern.
Thank you very much Mr. Chairman.
Chairman Akaka. Thank you very much, Senator Specter, for
your brief statement. I would now like to call on Senator
Begich and then we will hear from Senator Tester afterwards.
STATEMENT OF HON. MARK BEGICH,
U.S. SENATOR FROM ALASKA
Senator Begich. Mr. Chairman, because of limited time, I
will bypass my opening statement and look forward to the
questions.
Chairman Akaka. Thank you.
Senator Tester.
STATEMENT OF HON. JON TESTER,
U.S. SENATOR FROM MONTANA
Senator Tester. Thank you, Mr. Chairman. I am going to make
my statement very, very brief. First of all, thank you all for
being here. I appreciate it and look forward to a good question
and answer session.
The material I have gotten is, as I read through it, I can
only draw one conclusion and that is there are some things that
have been happening that are unacceptable. I think from a
medical standpoint you probably know that better than I since
I'm not in that profession, yet I guess it. In the testimony
that the panel comes forward with, I would just say that I want
to know what steps have been taken so it doesn't happen again.
I want to know what has been done so that there can be internal
reporting without any doubt about it if people see it. Because
people in the medical profession, overall--and the VA is no
exception--has some pretty competent people. They know what is
right and they know what is wrong. And for this to have
happened there absolutely was a breakdown in reporting, and
there was a breakdown in the overall program; and I want to
know how it is going to be fixed to eliminate some of the
things that have happened that you guys are going to be talking
about today.
With that, Mr. Chairman, I appreciate you having this
hearing, as always, and I hope we have an opportunity to ask
questions at the end. This is a very, very, very serious
situation, as Senator Specter pointed out from his perspective
in Pennsylvania. It's the same way across the country. I think
that we need to be sure that we have done everything possible
to make sure our veterans are treated the way they are supposed
to be treated and not put in harm's way because of poor medical
practices.
Thank you.
Chairman Akaka. Thank you very much Senator Tester.
Senator Isakson.
STATEMENT OF HON. JOHNNY ISAKSON,
U.S. SENATOR FROM GEORGIA
Senator Isakson. Thank you very much, Chairman Akaka. I,
too, will be brief because the testimony is far more important
from those who came than hearing from us.
The Charlie Norwood VA Center in Augusta is one of the
three hospitals where we had, I think, four instances or four
cases. Obviously, veterans in Georgia are very concerned and I
am very concerned. I have the highest regard for what has been
done in Augusta--what they have done regarding seamless
transition for the wounded warriors who come back to DOD and
transfer to VA--has been tremendous. They have been real
leaders.
But this is a very, very serious subject and it is very
important that we have a mechanism of accountability to assure
our veterans that we are doing everything we can to ensure that
all of the equipment and all of the use of equipment is
absolutely consistent with the highest forms of hygiene and
medical science.
So, Mr. Chairman, I appreciate very much your calling the
hearing. I look forward to hearing from the witnesses.
Chairman Akaka. Thank you very much, Senator Isakson.
I want to welcome the witnesses on our first panel. Dr. Tom
Nolan, a distinguished Senior Fellow with the Institute for
Healthcare Improvement will begin our discussion of quality
management. Also testifying will be Dr. Robert Wise on behalf
of the Joint Commission and Ms. Julie Watrous accompanied by
Dr. David Daigh and Ms. Vicki Coates on behalf of the Office of
Inspector General.
I thank all of you for being here this morning. Your full
testimony will appear in the record.
Dr. Nolan will you please begin?
STATEMENT OF THOMAS NOLAN, PH.D., SENIOR FELLOW, INSTITUTE FOR
HEALTHCARE IMPROVEMENT
Mr. Nolan. Mr. Chairman and Members of the Committee, thank
you for extending me the privilege of testifying at this
hearing on Quality Management on behalf of the Institute for
Healthcare Improvement, also known as IHI. I'm a Senior Fellow
at IHI. IHI is an independent not-for-profit organization
helping to lead the improvement of health care throughout the
world.
Although modern approaches to quality management originated
and evolved outside of health care, the application of these
methods has gained significant traction within health care. Two
landmark reports issued by the Institute of Medicine, To Err Is
Human in 1999 and Crossing the Quality Chasm in 2001,
highlighted the extent of defects in health care in the United
States and the opportunity for improvement. The ``Chasm''
report declared that the performance of any health care system
should be evaluated on six dimensions: safety, effectiveness,
patient-centeredness, timeliness, efficiency, and equity. The
authors of the report recognized that these dimensions were an
interacting set of qualities that must be pursued together and
in balance.
One of the pioneers of quality management was W. Edwards
Deming. Deming was one of the first theorists to recognize that
most problems of quality and safety arise because of faults of
the system rather than because of faults of individuals working
in the system.
A simple example illustrates this fundamental principle.
Consider how an Automated Teller Machine, or ATM, operates. A
customer inserts a bank card, enters the PIN, and then requests
an amount of money to be dispensed. In one type of machine, the
money comes out first; once the customer removes the money, the
bank card comes out. In another type of machine, the bank card
comes out first; once the customer removes the card, the money
comes out a simple reversal of steps in the process.
The choice between these two designs matters. The customer
is far more likely to forget the bank card at the ATM machine
if the money comes out first and then the bank card. A
directive sent to customers to ``please remember your card''
will not produce a sustained reduction in cards left at the
ATM.
Of course, health care is not banking, but our health care
system has thousands of similar opportunities for well-meaning
but fallible humans aiming to cure, comfort, or help veterans
to make mistakes that harm them. From the viewpoint of quality
management, the job of health care executives is to ensure
design of systems that both prevent these errors and mitigate
the harm when errors do occur.
By what method? Joseph Juran, another pioneer of modern
quality management, outlined three key elements of quality
management systems: quality planning or system design; quality
control in operations; and quality improvement.
How might these apply to the problem that has recently
surfaced at VA facilities of contamination in reprocessing of
endoscopes? Few systems in the U.S. could produce such thorough
and insightful reports as the Inspector General's report on the
``Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA
Medical Facilities'' and the ``National Center for Patient
Safety Review of Reprocessing Issues.'' Among other things, the
Inspector General's report recommended instituting more
reliable processes. The National Center for Patient Safety
suggested areas of system design that would be needed to
accomplish a more reliable overall system.
It is notable, however, that these two reports appear after
the fact. If instead they were an input to quality planning and
system design, this would help accomplish one of the key goals
of quality management: prevention of defects through design of
reliable systems. This is the frontier of quality management in
health care.
How would one know at a VA facility if quality management
and the resulting high quality were present? One could start by
ascertaining how the executives and managers view their role in
quality management. They know the trends in the performance of
the system through measurement and audit. They invest in
improvements to the system. They provide an environment in
which everyone in the system can improve the processes in which
they work. They promote cooperation between parts of the
system, for example, between a hospital and a clinic.
The Veterans Health Administration has been a leader in
applying quality control, modern quality control, and quality
improvement. We at IHI believe that the VHA could now lead the
country into the realm of quality planning and design of a safe
system, to prevent these problems from happening in the first
place.
Thank you.
[The prepared statement of Dr. Nolan follows:]
Prepared Statement of Thomas Nolan, Ph.D., Senior Fellow on behalf of
the Institute for Healthcare Improvement
Thank you for extending me the privilege of testifying at this
hearing on quality management on behalf of the Institute for Healthcare
Improvement--also known as IHI. I am Tom Nolan, Senior Fellow at IHI.
IHI is an independent not-for-profit organization helping to lead the
improvement of health care throughout the world. Founded by a small
group of health care leaders in 1991, IHI is based in Cambridge,
Massachusetts. We work to accelerate improvement by building the will
for change, cultivating promising ideas for improving patient care and
safety, and helping health care systems put those ideas into action.
IHI employs a core staff of approximately 100 people, along with
hundreds of faculty members. We maintain worldwide action- and results-
oriented partnerships with thousands of organizations, and tens of
thousands of individuals, offering comprehensive programs and
maintaining a large research agenda. Our aim is to improve the lives of
patients, the health of communities, and the joy of the health care
workforce. We believe that, in most settings, this could be
accomplished while simultaneously reducing per capita cost.
Although modern approaches to quality management originated and
evolved outside of health care, the application of these methods has
gained significant traction within health care. Two landmark reports
issued by the Institute of Medicine, To Err Is Human in 1999 and
Crossing the Quality Chasm in 2001, highlighted the extent of defects
in health care--and the opportunity for improvement. The ``Chasm
Report'' declared that the performance of any health care system should
be evaluated on six dimensions: safety, effectiveness, patient-
centeredness, timeliness, efficiency, and equity. The authors of the
report recognized that these dimensions were an interacting set of
qualities that must be pursued together and in balance.
One of the pioneers of quality management was W. Edwards Deming.
Deming was one of the first theorists to recognize that most problems
of quality and safety arise because of faults of the system rather than
because of faults of individuals working in the system.\1\ A simple
example illustrates this fundamental principle. Consider how an
Automated Teller Machine, or ATM, operates. A customer inserts a bank
card, enters the PIN, and then requests an amount of money to be
dispensed. In one type of machine, the money comes out first; once the
customer removes the money, the bank card comes out. In another type of
machine, the bank card comes out first; once the customer removes the
card, the money comes out--a simple reversal of steps in the process.
---------------------------------------------------------------------------
\1\ Deming WE. Out of the Crisis. Cambridge, MA: MIT Press; 1986.
---------------------------------------------------------------------------
The choice between these two designs matters. The customer is far
more likely to forget the bank card at the ATM machine if the money
comes out first and then the bank card. The customer knows how to
operate the machine--and suffers a loss if he forgets his bank card--
but still forgets the bank card if the money comes out first. A
directive sent to customers to ``please remember your card'' will not
produce a sustained reduction in cards left at the ATM.
Of course, health care is not banking, but our health care system
has thousands of similar opportunities for well-meaning but fallible
humans aiming to cure, comfort, or help patients to make mistakes that
harm them. From the viewpoint of quality management, the job of health
care executives is to ensure the design of systems that both prevent
these errors and mitigate the harm when errors do occur.
By what method? Joseph Juran, another pioneer of modern quality
management, outlined the three key elements of a quality management
system: quality planning (system design), quality control in
operations, and quality improvement.\2\
---------------------------------------------------------------------------
\2\ Juran JM, Godfrey, AB. Juran's Quality Handbook. 5th ed. New
York, NY: McGraw-Hill; 1999: 2-6.
---------------------------------------------------------------------------
Quality planning includes:
Designing processes capable of being executed reliably to
meet the needs of customers or produce the desired outcomes;
Training and certifying people in the skills necessary to
do the work. In health care, professional licensure and board
certification are ways in which this happens; and
Understanding the types of defect that are possible in the
system and developing a means for the routine tracking of the
occurrence of these defects.
Quality control includes:
Tracking performance during routine operations of key
factors in the process or elements of a clinical guideline;
Identifying failures in operation and mitigating the harm
caused to patients; and
Monitoring defects and the trend in their frequency--for
example, are drug overdoses going up, down, or staying the same?
Quality improvement includes:
Setting priorities for defect reduction;
Applying design concepts such as simplification, visual
controls, and waste reduction; and
Capturing the learning and spreading it to other
locations.
How might this thinking apply to the problem that has recently
surfaced in the VA of contamination in reprocessing of endoscopes? Few
systems in the US could produce such thorough and insightful reports as
the Inspector General's report on the ``Use and Reprocessing of
Flexible Fiberoptic Endoscopes at VA Medical Facilities'' and the
``National Center for Patient Safety Review of Reprocessing Issues.''
Among other things, the Inspector General's report recommended
instituting more reliable processes. The National Center for Patient
Safety suggested areas of system redesign that would be needed to
accomplish a more reliable overall system.
It is notable, however, that these two reports appeared after the
fact. If instead they were an input to quality planning and system
design, this would help accomplish one of the key goals of quality
management: prevention of defects through design of reliable systems.
This is the frontier of quality management in health care.
How would one know at a VHA facility if quality management--and the
resulting high quality--were present? One could start by ascertaining
how the executives and managers view their role in quality management:
They know the trends in the performance of the system
through measurement and audit. In a system such as the Veterans Health
Care system, this would include knowing the variation in performance
among different VHA sites.
They invest in improvements to the system. These
investments range from capital investments to install an electronic
medical record, to the investment of clinicians' time to test and
implement a protocol for treating heart attack victims effectively,
safely, and efficiently.
They provide an environment in which everyone in the
system can improve the processes in which they work. This environment
includes the freedom to surface problems in the system without fear of
retribution.
They promote cooperation between parts of the system--for
example, between a hospital and a clinic, or between the Department of
Defense health care system and the VHA.
The Veterans Health Administration has been a leader in applying
quality control and quality improvement. We at IHI believe that the VHA
could now lead the country into the realm of quality planning and
design of a safe system, to prevent these problems from happening in
the first place.
Resources: IHI Website: www.ihi.org
Chairman Akaka. Thank you very much, Dr. Nolan. And now we
will hear from Dr. Wise.
STATEMENT OF ROBERT A. WISE, M.D., VICE PRESIDENT OF STANDARDS
AND SURVEY METHODS, THE JOINT COMMISSION
Dr. Wise. Mr. Chairman, Ranking Member, and Members of the
Committee, on behalf of The Joint Commission, thank you for the
opportunity to testify at this very important hearing.
The Joint Commission accredits approximately 146 Department
of Veterans Affairs organizations, including all of its
hospitals. We strive to ensure that our Nation's veterans are
receiving high quality and safe care. The Joint Commission
accreditation is a risk-reduction process, which is designed to
assist health care organizations in reducing the safety risks
that are ubiquitous in health care.
Providing health care is fundamentally a human endeavor.
The Joint Commission emphasizes to health care organizations
the importance of having a systems approach to the delivery of
care that requires all staff to work together to create a
culture of safety similar to that found in high reliability
industries such as nuclear power and commercial aviation.
For example, the systems approach to reducing health care
associated infections within health care organizations involves
all parts of the organizations and all staff--from physicians
and nurses to housekeeping.
This systems approach requires organizations to establish a
just culture in which people feel safe to identify and report
errors has happened in the VA when problems with cleaning
equipment was discovered.
There are five critical components of the hospital
accreditation program. First is the need to meet evidence-based
standards and National Patient Safety Goals. Second is the
ongoing collection of data, such as patient outcomes,
complaints, and past survey results. Third is a periodic onsite
survey process in which unannounced onsite surveys emphasize
the need for organizations to be in continuous compliance with
all accreditation standards.
Surveys start with a group of patients and then each
patient's experience is traced through the organization. Thus,
a surveyor is able to both understand the care directly
delivered to these patients and how well the services are
integrated to produce good
outcomes.
Fourth, hospitals are required to complete an annual self-
assessment tool regarding its ongoing compliance with Joint
Commission standards. And last is public access to a robust
complaint process for families, patients, staff or anyone else
who has concerns about the care provided at an organization.
Raising the bar.
The Joint Commission helps organizations focus on priority
safety issues. Infection prevention remains one of the most
challenging issues in the safe delivery of health care. The
Joint Commission has worked closely with both government and
professional organizations to identify the most effect ways to
use scarce resources to reduce the number of HAIs.
The Joint Commission's Infection Prevention Standards
require the creation of a hospital-wide program that addresses
the specific risks to the organization, which must be re-
evaluated and modified on a yearly basis. Our surveyors examine
a sample of disinfection and sterilization processes. While not
every type of procedure is reviewed, the overall framework of
how the organization manages this portion of its infection
prevention program is always part of
accreditation.
The Joint Commission's experience with the VA. Because of
the way the VA is organized, the opportunities exist to achieve
high quality safe care when compared to other health care
organizations. Among the VA's attributes are a single medical
record for each patient across all care, an integrated health
care system allowing coordination of care, and the ability to
standardize medical equipment through centralized purchasing.
As an example of the positive attributes of the VA system, its
sophisticated information system allowed much of the
performance measured data required by the Joint Commission to
be gathered in an electronic manner, which has resulted in
almost uniformly strong performance on measures pertinent to
heart attack, heart failure, pneumonia, and surgical infection
prevention.
Furthermore, the power of the VA's unique environment was
demonstrated when more than a dozen organizations stepped up to
describe similar process breakdown in their own facilities.
This type of self-disclosure is unusual in an industry that too
often is seen hiding these types of problems.
What the Joint Commission is doing to improve safety in
health care. The Joint Commission learns lessons from high-risk
industries and from other disciplines such as systems
engineering that have been successful in creating safe
environments as they strive toward high reliability of their
processes. To create a high reliability organization an
attitude of safety must exist through all levels of an
organization. This expectation is essential to the Joint
Commission's accreditation process and its message.
The delivery of health care is a complex undertaking that
depends on human beings, therefore making it error prone. The
Joint Commission began years ago to help organizations become
safer organizations by expecting cultures of safety. This
direction will remain our top priority.
On behalf of The Joint Commission, I would like to thank
you again for this opportunity to testify.
[The prepared statement of Dr. Wise follows:]
Prepared Statement of Robert A. Wise, M.D., Vice President of Standards
and Survey Methods, The Joint Commission
introduction
Mr. Chairman, Ranking Member and Members of the Committee, on
behalf of The Joint Commission, I want to thank you for the opportunity
to testify at this very important hearing on the Oversight of VA
Quality Management Activities. Founded in 1951, The Joint Commission is
an independent, not-for-profit organization whose mission is to
continuously improve the safety and quality of care provided to the
public through the provision of health care accreditation and related
services that support performance improvement in health care
organizations.
While The Joint Commission has its roots in hospital accreditation,
over the years it has developed evaluation programs for a diverse array
of health care settings. Today, The Joint Commission evaluates and
accredits approximately 16,000 health care organizations and programs
in the United States, including ambulatory care, behavioral health
services, durable medical equipment providers and suppliers, home care,
hospices, hospitals, laboratories, and long term care facilities.
The Joint Commission accredits approximately 146 Department of
Veterans' Affairs organizations, including all of its hospitals. In
partnership with the Veterans Health Administration, the Joint
Commission strives to ensure that our Nation's veterans are receiving
high quality and safe care. We take situations such as the improper
cleaning or reprocessing of colonoscopy equipment at VA medical centers
very seriously and are working with the VA to identify the causes that
contributed to this problem and to develop solutions so that these
problems do not occur again.
the joint commission's accreditation process
Joint Commission accreditation is a risk-reduction process. The
Joint Commission's accreditation process is designed to assist
healthcare organizations in reducing the ubiquitous safety risks that
are an integral part of the delivery of the high quality health care
found in the United States and to then assess the level of the
organization's success. While risk will never be completely removed,
organizations can be highly successful in substantially reducing,
though not eliminating, errors.
The delivery of health care is complex and is fundamentally a human
endeavor. The role of The Joint Commission is to help organizations
decrease errors through compliance with state-of-the-art standards that
focus on a ``systems approach'' to delivering care. The Joint
Commission emphasizes to health care organizations the importance of
having all staff work together to create a culture of safety, and
establishing and maintaining a strong commitment from leadership to
evolve toward high reliability organizations such as those found in the
high risk industries of nuclear power and commercial aviation.
Systems Approach and Culture of Safety
Joint Commission efforts to improve patient safety in all types of
health care organizations are based upon a recognition of the need for
organization leaders and health care practitioners to adopt a ``systems
approach'' to managing risk and keeping inevitable human error from
reaching patients. For example, to help reduce the possibility of
acquiring and transmitting an infection, organizations need to
establish a robust, systematic infection prevention and control program
that starts with strong expectations from organizational leadership and
emphasizes communication and collaboration among all parts of the
organization. Attempting to eliminate healthcare associated infections
(HAIs) within health care settings requires attention to the entire
care delivery process and involves everyone, from physicians and nurses
to housekeeping and receptionists.
This systems approach requires organizations to establish a just
culture in which people feel safe to systematically identify and report
errors and near misses so that these events serve as important learning
experiences for the organization and its staff. The Joint Commission
recognizes that the VA is a leader in American medicine in creating
such a culture and has spent a great deal of time and effort in
creating and maintaining it. A safety-focused learning environment is
one in which safety is always top of mind and in which there is
constant vigilance by the organization's leaders and staff to identify
and eliminate risks. The Joint Commission's standards, survey process,
and other quality and safety improvement initiatives are designed to
stimulate and facilitate the creation of a culture of safety within
accredited organizations.
Accreditation Methods
The Joint Commission has created a framework to enhance patient
safety. The critical components needed to achieve lasting improvement
in organizational performance include:
Evidenced-Based Standards and National Patient Safety
Goals: Standards describe the successful operation of administrative
and other critical systems of the health care organization (e.g.,
medication management, infection control and prevention, and
leadership), while National Patient Safety Goals focus on specific high
risk processes that directly impact the quality and safety of care
delivered to patients (e.g., reduction of central line infections, safe
use of anticoagulation medications, reduction of wrong site surgery).
These requirements are developed in collaboration with experts and key
stakeholders with final review carried out by a Nation-wide field
engagement.
Ongoing Collection of Data: The Joint Commission initiated
the first national standardized data collection program for hospitals.
This program has formed the basis for Medicare's current pay-for-
reporting program; the VA has been an active participant in this
program since its inception. The data collected on each organization
reflect the degree to which the organization routinely delivers safe
and quality health care. Data on sentinel events, patient complaints,
past survey results, and performance measures are collected on every
Joint Commission-accredited healthcare organization and help The Joint
Commission focus and drive the onsite assessment.
Periodic Onsite Survey Process: Unannounced onsite surveys
emphasize the need for organizations to be in continuous compliance
with all accreditation standards. The organization's annual self-
assessment augments the onsite survey process. Additionally, the
availability of data about the performance of an organization gives the
Joint Commission surveyors an informed method to pick patients in the
organization whose experience can highlight how the organization is
performing in its delivery of quality and safe medical care; this data
allows the surveyors to use the important ``tracer methodology'' tool.
By starting with a specially selected patient and then ``tracing'' that
patient's experience through the organization, a surveyor is able to
both understand the care directly delivered to patients and the
integration of systems within the organization. For example, a patient
with a hospital acquired MRSA infection in the ICU will not only reveal
how an infectious patient is treated, but will also lead the surveyor
to appreciate the healthcare organization's entire infection prevention
and control program.
Completion of an Annual Self-Assessment Tool: In addition
to being assessed for compliance with standards during the onsite
survey, every health care organization is required to complete an
annual self-assessment of compliance with all standards. Part of that
process is an opportunity to discuss questions and concerns with Joint
Commission staff about the organization's approach to compliance with
the accreditation requirements.
Ready Public Access to a Robust Complaint Process: As a
way to receive ongoing information about the delivery of care at all of
the accredited organizations, there exists a toll-free complaint
hotline, the confidentiality of which is maintained for those who
report concerns about an accredited organization. This hotline is
available to patients, families, staff, or anyone else who might have
concerns about the care provided at an organization. There is a team
that investigates all complaints and has the resources to do an onsite
visit if required. Also, this information becomes part of the data used
by the Joint Commission to focus the onsite survey.
raising the bar
The Issue of Infection Prevention and Control
Infection prevention and control remains one of the most important
issues challenging the safe delivery of health care, and the approach
to eliminating infections is constantly changing and improving. The
Joint Commission is aware of this and strives to remain on the cutting
edge of initiatives and advancements in this area of health care. Since
there are numerous ways in which errors may occur in delivering health
care, The Joint Commission helps organizations to focus on priority
areas. For example, The Centers for Disease Control and Prevention
(CDC) estimates that tens of thousands of central line-associated
bloodstream infections occur annually; 12-25% of patients with these
infections die. The Joint Commission created a National Patient Safety
Goal requiring organizations to implement best practices to prevent
central line-associated bloodstream infections. These requirements
specify steps an organization must take and are based on evidenced-
based national guidelines (Compendium of Strategies to Prevent
Healthcare-Associated Infections
in Acute Care Hospitals, found at www.shea-online.org/about/
compendium.cfm). A March 2008 GAO report underscores the importance of
providing such explicit implementation guidance to hospitals trying to
reduce the transmission of infections. For example, the GAO stated that
the CDC has over 13 guidelines for hospitals on infection control and
prevention containing almost 1200 recommended practices. However, these
practices are not framed for easy implementation and in a manner that
provides a blueprint for action. The Joint Commission recognizes that
many of these practices are vague or framed as contingencies (e.g., if
this, then maybe that). To help to address the GAO's concern, The Joint
Commission was active in the development of the Compendium of
Strategies to Prevent Healthcare-Associated Infections in Acute Care
Hospitals. The Compendium addresses these implementation issues to help
hospitals be successful in a complex area.
In regard to the VA's situation pertaining to the use of
colonoscopes, because of the complexity of disinfection and
sterilization of equipment, the process can be error-prone. Though the
number of infections resulting from these processes is not as high as
other sources of HAIs, disinfection and sterilization remains a current
area of focus.
The need to decrease the number and seriousness of healthcare
associated infections remains a focus of Joint Commission
accreditation. In the last several years, The Joint Commission has
worked closely with both government (e.g., CDC) and professional
organizations (e.g., SHEA, APIC) to identify the most effective way to
use scarce resources to mitigate the continuing problem of HAIs. Four
infections are responsible for the majority of HAIs. The National
Patient Safety Goals identify the most dangerous of those infections
and create the expectation that the organization develops processes to
significantly lower their incidence in the hospital.
Simply knowing about problems will not immediately remedy the
situation, but it is the first step. Usually, an epidemic triggers an
investigation and the results of that investigation uncover system
failures or process breakdowns. For example, an outbreak of Hepatitis
in Nevada led to an investigation which uncovered the reusing of
syringes or needles in clinics. In the VA situation, there is no known
epidemic; the performance improvement process is working. The VA self-
identified a process problem, conducted an investigation, and is
implementing improvements. The lapses that happened within the VA
system are probably typical of what may be occurring within health care
organizations outside of the VA system. The Joint Commission will
actively disseminate what is being learned from this situation to other
health care organizations.
The Infection Prevention and Control Standards stress the fact that
everyone who works in the organization has a role in infection
prevention and control; must be given the tools and training necessary
to fulfill that role; and must be held accountable for following
procedures that minimize risks to patients. In addition, the Infection
Prevention and Control Standards require the creation of a program that
addresses the specific risks to the organization and which must be re-
evaluated and modified on a yearly basis.
A standard part of any infection control and prevention program is
the proper processing of equipment, devices, and supplies. This would
include all surgical
instruments, scopes, and other equipment. While the frequency of
infections directly associated with poorly cleaned equipment is not
well established (compared to, for example, those associated with the
insertion of devices in the body), the control and prevention of HAIs
nevertheless remains an integral part of all infection control
and prevention programs. The Joint Commission expects organizations to
use evidence-based national guidelines when developing infection
prevention and control activities. The two widely recognized guidelines
pertaining to cleaning, disinfecting,
and sterilizing equipment are the Centers for Disease Control and
Prevention's Healthcare Infection Control Practices Advisory
Committee's Guideline for Disin-
fection and Sterilization in Healthcare Facilities (http://www.cdc.gov/
ncidod/
dhqp/pdf/guidelines/Disinfection_Nov_2008.pdf, and The Society for
Healthcare Epidemiology of America's Multi-society Guidelines for
Reprocessing Flexible Gastrointestinal Endoscopes (http://www.shea-
online.org/Assets/files/position_papers/SHEA_endoscopes.pdf).
It is important to emphasize that, as part of every accreditation
survey, the surveyors will examine disinfection and sterilization
processes. Surveyors are trained to ask health care workers about
manufacturer's instructions and how they process medical equipment;
observe medical equipment being processed; and review information about
parametric, chemical, and biologic indicators. Surveyors are well
prepared to review how an organization manages the processing of
medical equipment. Surveyors receive ongoing training on the proper
management and processing of medical equipment, and they also have
access to infection prevention and control experts within The Joint
Commission who can guide them while conducting the onsite review.
A combination of cleaning, decontamination, disinfection, and
sterilization methods are used in handling medical equipment.
Regardless of the methods required, organizations are expected to
follow the manufacturer's guidelines. Additionally, organizations are
expected to have an on-going quality control process that ensures that
proper medical equipment handling protocols are being followed. In a
large hospital, there will be many procedures requiring disinfection
and sterilization in which many staff are involved. So, while not every
type of sterilization procedure is reviewed, the overall process of how
the organization manages this portion of its infection control and
prevention program is always part of an accreditation survey.
the joint commission's experience with the va
How the VA Differs from Other Health Care Systems
The Joint Commission has been asked to comment on how the VA health
care organizations perform in relation to private health care
organizations. Because of issues such as confidentiality and limited
resources, The Joint Commission does not routinely conduct such data
analyses. However, because of the way the VA is uniquely organized (for
example, the integration of care for a single episode is generally
unique to the VA system), the opportunity exists to achieve high
quality, safe care when compared to other health care organizations.
Among the VA's positive attributes are the following:
A single medical record for each patient across all care
settings supporting coordination of care
A centralized, integrated health care system allowing
coordination of care
A standardized credentialing and privileging process for
the appointment of medical staff
The capability to achieve enhanced epidemiology through
the integrated medical record
The ability to standardize medical equipment through
centralized purchasing
Leadership's commitment to and support of performance
improvement and the encouragement of a culture of safety that impacts
the entire delivery system
The power of the VA's unique environment was demonstrated through
its ability to reach out to the entire hospital membership once the
process breakdown in the colonoscopy cleaning process was discovered.
That more than a dozen organizations stepped up to describe similar
process breakdowns in their own facilities is unusual in an industry
that too often is seen as hiding these types of problems. The advantage
of the VA's medical record system was demonstrated through the
identification of all of the potentially infected veterans and the
seeming ease with which the VA contacted those patients with proper
next steps.
The Joint Commission's Process with the VA
The Joint Commission's Office of Quality Monitoring is working with
the VA to assist with the organizations that are experiencing issues
with colonoscope cleaning. According to the responses from the
organizations to date, no definitive connection between the equipment
and the positive diagnoses found in patients has been made. In
addition, prior survey history and prior complaint history were absent
any indication of infection control or equipment management problems at
any of the three facilities. While the organizations' responses were
thorough and credible, ongoing guidance with Joint Commission
management and leadership was sought related to whether any alternative
approaches should be considered due to the common theme among these
events and with the knowledge that the situation was being addressed by
the VA at a leadership level. The Joint Commission is continually in
communication with the VA regarding this matter, and will ensure
through survey and other means that follow-up is successful.
what the joint commission is doing
Complexity of Health Care
There are a number of industries operating within complex
environments that have been more successful in avoiding the number and
variety of errors that continue to plague the delivery of medical care.
Industries such as commercial aviation and nuclear power have had
similar types of challenges and have been more successful in creating
safe environments known as High Reliability Organizations. While a
complete discussion of what constitutes a High Reliability Organization
is beyond the scope of this document, it is important to at least list
the characteristics that are generally associated with organizations
that have achieved such a status. These five characteristics are:
Preoccupation with failure
Reluctance to simplify interpretations
Sensitivity to operations
Commitment to resilience
Deference to expertise
For an organization to incorporate these characteristics into its
fabric, an attitude of safety must exist through all levels of an
organization. While that achievement is quite difficult, at a minimum
an expectation that the organization will remain safe through the use
of established tools must be solidly part of the leadership's
attitudes. The expectation that health care organizations continually
move toward achieving this state of high reliability is at the core of
The Joint Commission's accreditation process and its components.
The Joint Commission continues to work with the VA in a
collaborative and collegial fashion to resolve the VA's infection
prevention and control issues. The Joint Commission's pledge to help
health care organizations help patients by providing them with useful
guidelines and tools (such as the Standards and National Patient Safety
Goals) drives The Joint Commission to constantly evolve and grow. In
addition to disseminating all lessons learned through its interaction
with the VA, The Joint Commission will:
Survey health care organizations using state-of-the-art
standards;
Guide and educate these organizations on the most critical
of issues through the National Patient Safety Goals;
Launch the Center for Transforming Healthcare which will
allow The Joint Commission to directly partner with the most innovative
and advanced organizations in the country to address the most critical
health care issues facing the industry today;
Regularly introduce new initiatives to the health care
industry, such as the forthcoming hand hygiene initiative;
Help health care organizations to reach the same high
reliability status as the commercial aviation and nuclear power
industries;
Share with the health care industry all lessons learned;
Help organizations to provide the highest quality, safest
care possible; and
Serve and protect patients.
conclusion
The delivery of health care is a complex undertaking with numerous
intricate and complicated processes that fundamentally depend upon
human beings, which tends to make these processes error-prone. The
Joint Commission began a number of years ago to help organizations
become safer environments for patients and staff by moving
organizations toward establishing cultures of safety that are
characterized by encouraging the reporting of problems and unsafe
practices; prospectively wrapping envelopes of safety systems around
high risk processes; and involving all parts of the organization in
keeping safety top of mind.
The Joint Commission is pleased that the VA has moved expeditiously
in this direction and has spent significant resources on creating the
safety infrastructure that can take them into the future. We note that
it was a VA employee who identified the risk to patients and the VA
leadership took appropriate action to minimize risks for patients being
treated at other VA facilities. These types of actions are critical to
the evolution of a culture of safety.
On behalf of The Joint Commission, I would like to thank you again
for this opportunity to testify. We are firmly committed to working
with all of our partners--public and private--to ensure continuous
improvement in the delivery of safe, quality health care.
Chairman Akaka. Thank you very much, Mr. Wise. We have a
quorum call at 10, so we're going to recess and be on the
floor. Ms. Watrous, when we return we will hear your testimony.
So the Committee stands in recess at the call of the Chair.
[Recess.]
Chairman Akaka. The hearing of the Senate Committee on
Veterans' Affairs will come to order.
Ms. Watrous, will you please begin with your testimony.
STATEMENT OF JULIE A. WATROUS, R.N., M.S., DIRECTOR, COMBINED
ASSESSMENT PROGRAM, OFFICE OF HEALTHCARE INSPECTIONS, OFFICE OF
INSPECTOR GENERAL, DEPARTMENT OF VETERANS AFFAIRS, ACCOMPANIED
BY JOHN DAIGH, M.D., ASSISTANT INSPECTOR GENERAL FOR
HEALTHCARE; AND VICTORIA COATES, MSW, DIRECTOR,
ATLANTA REGIONAL OFFICE
Ms. Watrous. Mr. Chairman and Members of the Committee,
thank you for the opportunity to testify today on a subject
that is very important to all of us and to me personally--
Quality Management in the VA. I have worked for over 20 years
in the VA to manage and improve the quality and safety of
health care for our veterans.
I will highlight the results of two reports that we have
recently published in this area. I will also briefly discuss
our recent report, on the reprocessing of endoscopes.
VHA employs many thousands of care providers who work
everyday to provide high quality health care to our veterans
and they mostly succeed. VA does some things very well and the
quality of care in VHA is generally high. However, the controls
need to be improved to ensure the consistent delivery of a
uniform medical
benefit.
I run the Combined Assessment Program (CAP) with site
visits to each VA facility approximately every 3 years. We
cover a variety of patient-care administration and quality
management topics. We have had findings in environmental
issues, medication management, and coordination of care, among
others.
In our report, ``Evaluation of Quality Management in VHA
Facilities Fiscal Year 2008,'' we summarize our findings from
44 CAP reviews. Quality management programs were generally
comprehensive and effective. Two of the 44 facilities had
significant weakness in their QM programs, and those were
Detroit and St. Louis. Specific recommendations for those two
sites addressed peer review, adverse event disclosure, and
patient safety among other issues. Both facilities submitted
acceptable action plans and we tracked the actions to
completion.
In our report, we recommended that patient complaints be
critically analyzed and actions taken when trends are
identified. Medication reconciliation needed to be actively
monitored, medical records needed to be reviewed for
inappropriate use of the copy and paste function, and a system-
wide fix needed to become a high priority. Compliance with
moderate sedation monitoring requirements needed to be
reinforced and the length of privileges granted to physicians
needed to match the length of the employment association. VHA
concurred and submitted an acceptable action plan.
VHA's Patient Safety Program is world renowned and has been
copied in other health care systems. However, there is room for
improvement. In our report titled ``Evaluation of VHA's
National Patient Safety Program,'' we made three
recommendations for improvement. All relevant patient data
sources needed to be assessed for patient safety significance
coordinated across the VA's Quality and Safety Programs and
used to drive change.
Organized coordinated oversight of the National Patient
Safety Program needed to be systematically provided and VHA
needed to develop a plan to systematically review all aspects
of the program for efficiency and effectiveness, and revise as
needed. VHA concurred and submitted an adequate action plan.
The third report to discuss today is titled ``Use and
Reprocessing of Flexible Fiberoptic Endoscopes.'' This review
was a reaction to recent events. We reviewed the topic at
Murfreesboro, Tennessee, Miami, Florida, and Augusta, Georgia,
in detail. We also conducted unannounced visits to 42 other
reprocessing sites to assess the extent of related problems
across the system. Dr. Daigh testified on this topic before the
House Veterans' Affairs Subcommittee on Oversight and
Investigation last week.
In our report we concluded that facilities had not complied
with directives to ensure appropriate endoscope reprocessing.
We also noted that the Clinical Risk Assessment and Advisory
Board has been an effective mechanism for providing guidance on
the disclosure of adverse events. We recommended that VHA
ensure compliance with relevant directives regarding endoscope
reprocessing, explore the possibilities to improve the
reliability of endoscope reprocessing, and review the
organizational structure and make necessary changes to
implement controls that will ensure compliance.
Mr. chairman, thank you again for the opportunity to appear
before the Committee. We would be pleased to take your
questions.
[The prepared statement of Ms. Watrous follows:]
Prepared Statement of Julie A. Watrous, RN, MS, Director, Combined
Assessment Program, Office of Healthcare Inspections Office of
Inspector General, U.S. Department of Veterans Affairs
Mr. Chairman and Members of the Committee, thank you for the
opportunity to testify today on Quality Management in the Department of
Veterans Affairs. I will focus on the results of two reports that we
recently published in this area (1) Healthcare Inspection--Evaluation
of Quality Management in Veterans Health Administration Facilities
Fiscal Year 2008; and (2) Healthcare Inspection--Evaluation of the
Veterans Health Administration's National Patient Safety Program. I
will also discuss our recent report, Healthcare Inspection--Use and
Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical
Facilities. I am accompanied by Dr. John D. Daigh, Assistant Inspector
General for Healthcare Inspections, Office of Inspector General (OIG)
and Victoria H. Coates, Regional Director of the Atlanta Office of
Healthcare Inspections, OIG.
background
The Joint Commission (JC), an accrediting body, describes quality
management (QM) as a continuous process that involves measuring the
functioning of important patient care processes and services and, when
indicated, identifying changes that enhance performance. JC conducts
triennial surveys at all Veterans Health Administration (VHA) medical
facilities. However, external surveyors typically do not focus on VHA
requirements. Also, the JC changed the focus of their survey process in
2004, resulting in a reduction in the JC's onsite attention to those
standards that define many requirements for an effective QM program.
Since the early 1970s, VA has required its health care facilities
to operate comprehensive QM programs to monitor the quality of care
provided to patients and to ensure compliance with VA directives and
accreditation standards. Several VHA offices have created programs to
evaluate and seek improvement in patient care and safety. Each of these
offices has access to comprehensive patient databases and can obtain
reports that assess performance against metrics, such as procedure
complication rates, surgery waiting times, and patient satisfaction.
Some specific programs have developed databases tailored for their
patient care review needs, such as the National Surgical Quality
Improvement Program (NSQIP), the Inpatient Evaluation Center, and the
Cardiac Assessment Reporting and Tracking System.
In 1999, VHA issued the National Patient Safety Improvement
Handbook, which established a policy for identifying, reporting, and
mitigating vulnerabilities that may result in adverse patient events
(such as patient falls and medication errors). VHA facility staff are
expected to identify and report actual adverse patient events. Facility
patient safety managers (PSMs) prioritize them for severity and
probability. A root cause analysis (RCA) may be used by facility staff
to determine the reasons why events occurred and to try to prevent
future occurrences. The handbook describes two types of RCAs--
aggregated and individual. Aggregated RCAs may be used for four events
(falls, adverse drug events, parasuicides [actual or attempted
suicides], and missing patients) for which data are gathered over time
and evaluated annually. Individual RCAs are conducted for more serious
events. PSMs enter adverse event information into the National Center
for Patient Safety's (NCPS) database. The NCPS has access to all
reported patient adverse events, close calls, and RCAs across the VA
system.
The OIG is required by Public Law 100-322, Veterans' Benefits and
Services Act of 1988, to oversee VHA's QM programs at every level.
Oversight is provided through four different approaches:
Combined Assessment Program (CAP) Reviews--These site
visits are scheduled at each VHA facility approximately every 3 years
and cover a variety of patient care administration and QM topics. The
QM program review has been a consistent focus during CAP reviews since
1999.
National Reviews--These system-wide reviews vary by topic
and scope but have repercussions for VHA policies and practices. The
review of VHA's National Patient Safety (NPS) Program is an example of
a national program review.
Hotline Complaint Inspections--These inspections address
complaints made to the OIG Hotline. They may address issues at one
facility, several facilities, or may be wider in scope.
Community Based Outpatient Clinic Reviews (CBOC)--This new
program of site visits began in April 2009. The goal is to visit all
CBOCs over time. A variety of quality and safety topics will be covered
in these reviews.
the evaluation of quality management in vha facilities
The OIG conducted CAP reviews in 44 VA medical facilities during
fiscal year (FY) 2008. To evaluate QM activities, we interviewed
facility directors, chiefs of staff, and QM personnel, and we reviewed
plans, policies, and other relevant documents. Some of the areas
reviewed did not apply to all VHA facilities because of differences in
functions or frequencies of occurrences.
The components of a typical QM program are not standardized. For a
complete list of the program areas we defined to comprise a
comprehensive QM program, please see our report,\1\ but some of the
areas we chose to include are:
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\1\ Healthcare Inspection--Evaluation of Quality Management in
Veterans Health Administration Facilities Fiscal Year 2008, May 19,
2009.
QM and Performance Improvement (PI) committees,
activities, and teams.
Peer reviews.
Patient complaints management.
Disclosure of adverse events.
Patient safety functions.
Reviews of patient outcomes of resuscitation efforts.
Medical record documentation quality reviews.
As a result of our review we made five recommendations, which VHA
concurred with:
Patient complaints needed to be critically analyzed and
actions taken when trends are identified.
Medication reconciliation needed to be actively monitored.
Medical records needed to be reviewed for inappropriate
use of the copy and paste functions and a system-wide fix needed to be
made a high priority.
Compliance with moderate sedation monitoring requirements
needed to be reinforced.
The length of privileges granted to physicians needed to
match the length of the employment association.
In addition to these five issues, we expressed concern about the
following seven areas and will continue to monitor them:
Adverse event reporting.
Utilization management.
Patient flow.
Peer review.
RCA timeliness.
Implementing and evaluating corrective actions.
Continuous performance monitoring for physicians.
Although all 44 facilities we reviewed during FY 2008 had
established comprehensive QM programs and performed ongoing reviews and
analyses of mandatory areas, the St. Louis VA Medical Center and John
D. Dingell VA Medical Center, Detroit, Michigan, had significant
weaknesses. While facility senior managers supported their QM programs
and were actively involved, they needed to implement and/or reinforce
efforts to improve action item implementation and evaluation.
evaluation of vha's national patient safety program
On June 18, 2009, we published the results of our evaluation of
VHA's NSP Program.\2\ We reviewed the VHA National Patient Safety
Improvement Handbook (VHA Handbook 1050.01, May 23, 2008), reports,
training materials, and other relevant documents. We interviewed NCPS
staff in July 2008, as well as staff at VA Central Office, at the
Veteran Integrated Service Network (VISN) level, and at the facility
level. Also, we assessed patient safety review results and feedback
gathered from VHA facilities during CAP reviews.
---------------------------------------------------------------------------
\2\ Healthcare Inspection--Evaluation of the Veterans Health
Administration's National Patient Safety Program.
---------------------------------------------------------------------------
It is important to identify as many safety concerns as possible
from all available sources in order to understand the magnitude of the
concerns and prioritize actions to address them. Many programs under
the broad umbrella of quality and safety have the potential to identify
safety issues and adverse events. At the facility level, the following
programs comprise a partial list:
Patient incident reporting.
Patient advocate.
Peer review.
Tort claim information system.
Morbidity and mortality conferences.
NSQIP.
Infection control.
While some facility staff may share data from these programs to
identify patient safety issues and events, no such sharing is required
by directives. Most of these programs require facility data to be
entered into databases or sent in reports that are available to the
responsible program offices at the VA Central Office level. If these
databases were available to all relevant program offices for use in
data analysis, it is possible that resulting actions could improve
patient care quality and safety. However, quality and safety
information is not always well coordinated among VHA entities.
Patient safety could be improved by better coordinating existing
data sources in various programs, expanding the identification of
patient events through the addition of automated systems, making
appropriately identified data available for analysis, and using the
data to drive change. High frequency event types should be given
appropriate attention.
We found that although the NCPS monitors selected data elements
within required processes, it does not provide comprehensive oversight
of the NPS Program. It is expected that organized, coordinated
oversight of VHA programs be provided to determine whether policies are
effective and relevant or in need of revision. Currently, there appears
to be redundancy and lack of role clarity between NCPS and VISN staff,
resulting in confusion. The NCPS does not document the systematic
evaluation of required patient safety processes to determine if
revision is needed. It is a general philosophy of any quality review
activity to continually assess and seek to improve key processes. We
identified the following four areas that would benefit from systematic
assessment and possible revision.
Cumbersome processes and content.
Follow-up of action items.
Inter-rater reliability.
Adverse event disclosure.
As a result of our review, we made three recommendations:
All relevant patient data sources needed to be assessed
for patient safety significance, coordinated across VHA's quality and
safety programs, and used to drive change.
Organized, coordinated oversight of the NPS Program needed
to be systematically provided by either the NCPS or another VHA entity.
VHA needed to develop a plan to systematically review all
aspects of the NPS Program for efficiency and effectiveness and make
revisions as appropriate.
VHA concurred with our recommendations and provided an
implementation plan that is responsive to our recommendations.
use and reprocessing of flexible fiberoptic endoscopes
at va medical facilities
Based on requests from the VA Secretary, the Chairmen and Ranking
Members of our oversight committees, and other interested Members of
Congress, we conducted a review of the reprocessing of endoscopic
equipment at several specific VA medical centers (VAMCs), and assessed
the extent of related problems throughout VHA.\3\ We visited the
facilities that had been the subject of considerable media attention:
the Bruce W. Carter VAMC in Miami, FL; the Tennessee Valley Healthcare
System-Alvin C. York Campus in Murfreesboro, TN; and the Charlie
Norwood VA Medical Center in Augusta, GA. We reviewed applicable
regulations, policies, procedures, guidelines, and conducted
unannounced onsite visits at 42 randomly selected VHA facilities to
examine pertinent endoscope reprocessing documentation.
---------------------------------------------------------------------------
\3\ Healthcare Inspection--Use and Reprocessing of Flexible
Fiberoptic Endoscopes at VA Medical Facilities, June 16, 2009.
---------------------------------------------------------------------------
We estimated that VA medical facilities:
Have the appropriate endoscope Standard Operating
Procedures (SOPs) available 78 percent of the time.
Have documented proper training of staff 50 percent of the
time.
Are compliant with both SOPs and documentation of
competency 43 percent of the time.
We concluded that facilities did not comply with directives to
ensure compliance with reprocessing of endoscopes, resulting in a risk
of infectious disease to veterans. Endoscope reprocessing requires a
standardized, monitored approach to ensure that these instruments are
safe for use in patient care. The failure of medical facilities to
comply on such a large scale with repeated alerts and directives
suggests fundamental defects in organizational structure.
As a result of our review, we made three recommendations:
Ensure compliance with relevant directives regarding
endoscope reprocessing.
Explore possibilities for improving the reliability of
endoscope reprocessing with VA and non-VA experts.
Review the VHA organizational structure and make the
necessary changes to implement quality controls and ensure compliance
with directives.
VHA has concurred with our recommendations and will provide an
action plan for implementation within 30 days.
conclusion
The OIG works diligently to provide oversight of quality and safety
activities and programs in VA's large and complex health care system.
While our reports indicate that VA has a program in place for quality
management and patient safety activities, it is important that VHA and
facility senior managers strengthen QM programs through increased
compliance with existing Joint Commission standards and VHA
requirements and continue to improve the NPS Program's effectiveness
and oversight.
When internal controls and supervisory monitoring fail, as in the
case of endoscope reprocessing, it is essential that appropriate
actions are taken to standardize the processes, strengthen the
monitoring, and holding staff accountable for performance failures.
Mr. Chairman, thank you again for this opportunity to appear before
the Committee. We would be pleased to answer any questions that you or
Members of the Committee may have.
Chairman Akaka. Thank you very much for your testimony.
Senator Johanns if you have any opening statement, you may
give it at this time.
STATEMENT OF HON. MIKE JOHANNS,
U.S. SENATOR FROM NEBRASKA
Senator Johanns. Mr. Chairman, if I might, I would like to
give just a very brief opening statement.
First of all, I do want to say I am glad to be here. I
really appreciate the Chairman calling this hearing. I am
especially interested to have an opportunity to visit with the
witnesses. I appreciate your testimony.
I will tell you as a Member of the Committee I was very
concerned about the report that was released by the VA
Inspector General last week entitled, ``Use and Reprocessing of
the Flexible Fiberoptic Endoscopes at VA Medical Facilities.''
It highlighted what I would regard as widespread lapses in a
standard of equipment handling. The report was initiated after
several deeply troubling instance in various VA facilities,
which potentially exposed veterans to deadly viruses:
Hepatitis, HIV.
The veterans who had sought treatment at the locations were
called back for testing and some of them discovered that they
had been infected. The VA Inspector General decided to conduct
a more widespread survey and its findings were nothing to be
proud of. Out of the 42 facilities inspected by the IG, less
than half were following the correct procedures. I recognize
that the failing rates of compliance with these two factors
does not necessarily mean that the equipment was not cleaned
properly. It does not necessarily mean that the staff do not
know how to use the equipment.
But I think what it does mean is that something is wrong in
terms of the management of VA, since these lapses occurred
after the instance of contamination at other VA facilities.
They occurred after the VA sent out several directives
concerning these issues and after a lot of media attention.
I must admit, I do not understand how VA medical facilities
were not 100 percent alert after all of this. I am sure that by
now you are familiar with the IG report I am describing--
probably very familiar--but I just want to quote one part.
``The failure of medical facilities to comply on such a large
scale with repeated alerts and directives suggest fundamental
defects in organizational structure.''
I could not agree more. After the report was released I did
write a letter to the Secretary outlining my personal concerns.
I believe we are fortunate to have representatives of non-VA
institutions who have the best and most timely information
about the specific challenges facing our veterans who give us
their thoughts. Perhaps they have some suggestions on how to
address the problem.
I am especially concerned about what I quoted; this
structural issue really, really worries me. I found as a
previous Cabinet Member that those are the most difficult
problems to address. So, I am very anxious to hear how we fix
what we are dealing with in the go-forward plan.
Thank you, Mr. Chairman.
Chairman Akaka. Thank you very much, Senator Johanns.
Now for questions. Dr. Nolan, you made a very good point in
your testimony when you said that too often we are reacting to
problems instead of designing our systems to prevent them. How
would you suggest we restructure our systems to reduce the
chances of these kinds of errors that are occurring?
Mr. Nolan. Well, it starts with aims. We have many, many
facilities in the VA system. The question, say of the endoscope
reprocessing is, are these problems limited to a few facilities
or is it systemwide?
My prediction would be that even the best facilities will
not be defect free. So, if this is a priority systemwide, my
view is that unless we take a design approach--as opposed to
each facility fixing its own problems we are never going to get
to the point where all of us want to see this care for our
veterans. What would that mean?
It would mean that we design systems that can be executed
reliably across the board in different settings. This is not a
trivial matter; it is not a matter to be left to individual
facilities. In my testimony I mentioned just a small change of
whether the bank card or the money comes out that can have a
big effect. Well, you can imagine all of the small changes
which can have an effect on this.
My recommendation would be start with quality design with a
qualified group of people, including people for facilities.
Make sure we have processes that can be executed reliably then
put the accountability for the quality control and quality
improvement on facilities. But if we start going back to each
facility we will be back in the same situation in the near
future.
Chairman Akaka. Dr. Wise, in light of some of the problems
in VA's quality management as described in the IG reports, will
you be changing the way in which you evaluate VA and private
hospitals?
Dr. Wise. There has been. Obviously we have taken a lot of
this information and brought it back to our surveyors. The way
we do surveys is we have an extensive program on infection
control and prevention. We tend to be driven by where the
scientific evidence is, where those scarce resources should be
used.
Currently people talk about the four major causes of
infection--things like catheter-related, ventilator, et cetera.
As we start to hear about these other types of processes we
need to pull back and make decisions of how we should begin to
take a look at this which is disinfection and sterilization.
Actually over the last year we have run into significant
problems around the issues of steam sterilization, which is
quite different. It is when instruments are then sterilized by
steam and brought forward. We now know that there have been
significant problems with steam sterilization. We are hearing
some very concerning issues about what is going on with
colonoscopies and all endoscopes. There is no question now that
we are going to pull back and take a look at a much broader
process, specific to what is happening with this area and that
will become more of a focus now of our survey.
Chairman Akaka. Ms. Watrous, we have heard about the
problems with prostate cancer treatments in Philadelphia VA.
How did the Philadelphia VA Hospital perform during your last
inspection?
Ms. Watrous. Thank you for that question. We did a CAP
review there in September 2007. There were a number of issues
that we identified needing improvement there including peer
review, tracking patient complaint data, improving processing
time for patient safety reviews called Root Cause Analyses, et
cetera.
There were a total of 12 recommendations that we found
there at Philadelphia, so they certainly had issues that they
needed to fix.
Chairman Akaka. Dr. Nolan, a recent news story described a
problem where a doctor from the University of Pennsylvania, who
was under contract with VA put radioactive implants in the
wrong place in dozens of prostate cancer patients. Isn't it
part of good quality management for a health care system to
require proof of competency to perform a procedure before
privileging a physician to do it?
Mr. Nolan. Yes, of course, it is part of quality planning
and design. I am not particularly familiar with all the details
of that incident, but the question becomes, is this particular
physician a special case or is the variation in that system in
need of redesign?
Chairman Akaka. Ms. Watrous, what role has the Veteran
Integrated Service Network played in overseeing the quality of
health care in Veterans Administration and what role do you
think they should play?
Ms. Watrous. Each of the Network offices has a dedicated
staff person for quality management--a quality management
officer. They are expected to do oversight of their
facilities'--the facilities within that network--quality
management programs. I know that is probably variable across
the system. We are actually working on a task force with the
VHA folks to develop an assessment tool that can be used across
all of the facilities and all of the network so there is more
consistency in their quality management programs.
I do think they have a role to play, an important role.
Again, we focus on the systems. If the system is in place it is
much more likely--an important alert or any kind of new
direction coming down from headquarters--is more likely to be
implemented if we have good systems in place. All similarly, if
there is an adverse event--we all hope that there won't be--but
when there is an adverse event, if the systems are in place it
is more likely to be identified and addressed and, hopefully, a
review process put together so that that particular event will
not repeat itself.
Chairman Akaka. Dr. Daigh, do you have any further comments
on that?
Dr. Daigh. Yes, sir I have a few. I would say that I've
been disappointed at the VISNs ability to influence what
happens with respect to the delivery of health care, the
quality of health care across VISNs.
We looked at the peer review process sometime ago and there
was a specific role for VISNs to try to ensure that peer review
is accomplished in a meaningful way. So, if you have a hospital
that has a large number of internists, they may well have a
pool of physicians who can provide peer review. If you have a
hospital that has some specialist for which there are not very
many, you would hope that there would be a system where within
the VISN one could pool a number of experts who could then
provide adequate peer review.
So, from my point of view I think we see hospitals having
difficulty individually. We do not see hospitals have
difficulty by VISNs. So I am not confident that VISNs are
appropriately affecting quality of care issues.
Chairman Akaka. Thank you. Senator Burr.
Senator Burr. Thank you Mr. Chairman. Dr. Nolan let me ask
you to look at the VA in comparison to sort of the private
health care infrastructure that we have in this country. In the
private health care system do they routinely not sterilize or
disinfect reprocessed devices?
Mr. Nolan. Not intentionally.
Senator Burr. And is it my understanding that a
manufacturer of a reprocessed device issues with that device
their recommendations about sterilization or disinfection and
in addition to that there is a back up in the application
approval process at FDA there is also some requirements that
FDA issues as to the use of that equipment?
Mr. Nolan. Yes.
Senator Burr. So is it safe for everybody to assume that a
health care professional hired to work with this equipment
would either know the manufacturer's recommendation for
sterilization/disinfection or the FDA's recommendation that
probably dovetails with the manufacturers' for disinfection or
sterilization?
Mr. Nolan. Well, let's assume what they may not have is and
it may not be working in a process which reliably allows them
to carry out their intention.
Senator Burr. So why would an institution not require a
health care professional to follow the manufacturer's
recommended sterilization and/or the FDA's recommendation? What
benefit would there be?
Mr. Nolan. I cannot see a benefit of requiring and not to
follow it. The question is are they in systems which allow them
to follow it reliably? They may be able to follow it 90, 95
percent of the time.
Senator Burr. Is there a significant cost to the
sterilization/disinfection?
Mr. Nolan. I am not an expert in disinfections.
Senator Burr. Dr. Wise can you help me at all?
Dr. Wise. The types of devices you are talking about are
quite complicated. Actually some of these colonoscopies will be
20, 25 different steps and the problem is if there are so many
changes going on in the actual devices that a device that you
are using today may end up having changes that you are not
using----
Senator Burr. And in fact, the safety alerts that were put
out by the VA actually were put out because of changes in
certain devices if I understand the chronology of those alerts.
Dr. Wise. That I am not sure, but I do know that one of the
things that we are talking about--systems--is that when you are
dealing with 20-25 steps, you probably need to have something
on the wall that says, ``here you do this, this, this.'' It is
pretty much like a checklist. If you are trying to commit those
steps to memory, the chance that you are going to miss one or
after a while start doing the same thing consistently, becomes
much higher.
So, that's really one of the changes that needs to be
made--when you walk into one of these types of departments you
would see that.
Senator Burr. Well, I will turn to the AIG. I take for
granted that there was not a step-by-step process clearly
visible for individuals to follow.
Dr. Daigh. The directive from VHA was that there would be
on the wall, basically where these reprocessing occurs, the
instructions for the different kinds of scopes that that
facility had.
Senator Burr. And you found that----
Dr. Daigh. And we found that about 20 percent of the time
that instruction was not there. So you would think that there
was non-compliance about 20 percent of the time for that
feature. The second feature was that we would expect that the
training records of the individuals who actually cleaned the
scopes would reflect that they had knowledge and expertise to
clean the different variety of scopes that the facility had and
that was not present a significant percent of the time. So,
only 43 percent of the facilities that we visited met both
criteria.
Senator Burr. According to your report in 1998, a VA panel
recommended the creation of the National Center for Patient
Safety Office and a director was hired shortly thereafter
reporting directly to the Under Secretary for Health, VA. Your
report further states that since 2007 the National Center for
Patient Safety director has been reporting to the Associate
Deputy Under Secretary for Health and Quality and Safety.
You get any understanding in your investigation as to why
the change?
Dr. Daigh. We did not explore that administrative change. I
have no comment on that.
Senator Burr. OK. I will take it up with the VA, but
clearly quality and safety seems to have diminished from a
standpoint of importance given that your recommendation and
quick action in 1998 put it directly under the Under Secretary
of Health and now we know how--when you sort of knock down the
food chain--all of a sudden the focus begins to change.
In your opinion would an organization committed to patient
safety lower it's Safety Office status?
Dr. Daigh. I have not discussed with the Under Secretary of
Health why they made or did not make that change, nor have I
discussed with the principals who you are talking about, who
either manage patient safety or who the Patient Safety Director
reports to. I take all of those individuals to be serious
individuals committed to patient safety; and how VHA determines
the structure within the organization, I have not been asked to
look at and have not looked at that.
Senator Burr. I appreciate that. Mr. Chairman, I will have
to have a second round with this panel. Let me just say to Dr.
Cross and his colleagues, I deeply respect the work that they
do. Now is when I separate the high regard that I hold them in
and the functions of the institution, of the agency. This is a
very, very serious issue. If we were here with one veteran who
had been infected because we had not sterilized or disinfected
correctly, I would think that is important. If it were one, we
would be here looking at the procedure, and I am not here to
highlight the warts at VA. I am here after 11 alerts to say
enough's enough.
I thank the Chair.
Chairman Akaka. Thank you very much, Senator Burr.
Senator Tester.
Senator Tester. Thank you, Mr. Chairman. Dr. Daigh, to just
kind of follow up on some things that you said to some previous
questions. You said that 20 percent of the hospitals had no
instructions on how to use the equipment, 80 percent did; and
then you said, if I heard you right, 43 percent of the
hospitals only had instructions and what I interpret as kind of
a job logbook. Is that what you meant?
Dr. Daigh. When we were asked to look at the endoscopic
issue at a national level, having looked at three sites in the
report it became clear to me that the reprocessing of
endoscopes was a high risk area. So we then had to come up with
a way to try and address it as a national problem. I do not
have individuals on my team with the knowledge to actually
reprocess an endoscope. So we read the directives very
carefully as to what VHA asks the facilities to do and then we
checked to see whether they had done two of those things.
Senator Tester. Procedures.
Dr. Daigh. That is correct. So what I am saying is that
essentially 80 percent of the time they had the directions on
what to do and a much lower percent of the time they had the
training records to demonstrate that the people, or that one
person who cleans the scopes was adequately trained.
Senator Tester. OK. Thanks. Earlier you talked about the
fact that the VISNs did not have the ability to influence
individual hospital quality of care, from your perspective.
Dr. Daigh. From my perspective, what I see is difficulty in
individual hospitals. The VISNs, in my view, have not stepped
in to ensure consistent high quality of care across their
facilities.
Senator Tester. Is there any recommendation that you would
have so that those individual hospitals could be influenced in
a way to follow the procedures?
Dr. Daigh. I believe that it would be appropriate to look
at the organization within hospitals which are now organized
very differently--VISNs which are organized very differently--
to look at the organizational structure and determine if that
is best for the current needs for VHA. I think at the same time
one needs to look at the data that you need to capture to
manage and look at the flow of data through the organization.
Senator Tester. Were you able to capture, in fact, whether
the VHA directives actually got to the hospitals? And if you
want to defer that you can.
Dr. Daigh. I would have to get back to you on that, but I
do not believe there is any doubt that they got there. I can
get back to you on that. I will check and if I am in error I
will say, but I do not believe there was any doubt about that.
Senator Tester. Dr. Wise, can you briefly explain how the
Joint Commission conducts the accreditation surveys?
Dr. Wise. There are several parts. One is that we are
constantly collecting information about organizations
throughout the cycle. We talked about patient complaints and
other information that allow us to understand what the
potential strengths and weaknesses of an organization are. When
you go into a hospital it is a big place. There are a lot of
places to look at in a reasonably short period of time. So that
information allows us to target in on patients who in some way
are affected by it.
Senator Tester. So your standard is zero tolerance?
Dr. Wise. For an organization to remain accredited it must
adhere to all standards a hundred percent of the time.
Senator Tester. OK. And is that the same as with the
private sector?
Dr. Wise. Yes. They are exactly the same standards.
Senator Tester. Exactly the same standards. Have you done
any evaluations in the private sector?
Dr. Wise. We look at about over 4,000 hospitals.
Senator Tester. Do you see that the VA is--and by the way I
agree with what Senator Burr said, one case is bad--but I want
to know where the VA ranks in relationship to the private
sector as far as occurrences of screw ups in this particular
area.
Dr. Wise. That question was actually asked, to see if we
could pull the data. We have lots and lots of data. That
particular analysis has not been completed; so it is something
that we have the data for, but not the effort required to do
it. So, we do not know. But we do know the kinds of
infrastructure that exist within the VA that does not exist
within other parts of the private sector, which I had talked
about in my testimony, which in fact, gives it a leg up in
being able to do a whole lot better than many parts of the
private sector.
Senator Tester. OK, I am out of time. I will pass it on.
Thank you, Mr. Chairman, and I thank the panelists.
Chairman Akaka. Thank you very much, Senator Tester. Now we
can move on to questions from Senator Isakson.
Senator Isakson. Thank you, Mr. Chairman. Following up on
that question, so there is no relevant data on private sector
occurrence of these infections in terms of if it happens at all
or how frequent it happens?
Dr. Wise. We do not have that data at our fingertips
through the accreditation process, no.
Senator Isakson. Do you have any idea, Dr. Nolan?
Mr. Nolan. I do not have the data, no.
Senator Isakson. Ms. Watrous, in terms of the VA in
previous history, has this type of occurrence happened before?
Ms. Watrous. I am sorry, I do not have data for that.
Dr. Daigh. What do you mean exactly, sir? Do you mean----
Senator Isakson. Infection from a procedure--either
colonoscopy or endoscopy.
Dr. Daigh. There have been a number of instances where
instruments have not been cleaned or sterilized correctly,
leading to issues with patients. So, in the prostate biopsy
issue, which was cited earlier, and certainly with respect to
the insertion of cranial implants some years ago, there were
some issues around that. So I am aware of isolated cases where
this has occurred, yes, sir.
Senator Isakson. Ms. Watrous, seeing these occurrences at
the three VA hospitals, you have in place a procedure called
CAP--Combined Assessment Program?
Ms. Watrous. Yes.
Senator Isakson. And those are every 3 years in each
facility. Is that correct?
Ms. Watrous. Yes.
Senator Isakson. Are you now making a specific inspection
of the disinfecting process of this equipment as a part of
that?
Ms. Watrous. I believe we will be adding that to our cadre
of topics, yes.
Senator Isakson. Ms. Coates, I know you are in Georgia. It
is good to have a hometown person here. Are you in Clermont or
are you in the regional office in Atlanta?
Ms. Coates. I am at the regional office on Clermont, yes.
Senator Isakson. Is Augusta VA, the Charlie Norwood
Hospital, is that in your region?
Ms. Coates. Yes, sir, it is.
Senator Isakson. Since the incident or instances that took
place there, has there been a change in procedures or have you
implemented a program to prevent the possibility of infection
being transferred with this type of equipment?
Ms. Coates. My office has done that. I am working with Ms.
Watrous to develop and design that for the CAP reviews.
Senator Isakson. Would your office be the appropriate
office to put in new procedures or direct new procedures?
Ms. Coates. We would identify issues during our CAP reviews
and make recommendations to VHA to make improvements.
Senator Isakson. So you are in the process of determining,
in terms of the CAP inspections, what procedures you are going
to create to ensure redundant inspections of this type of
disinfectant?
Ms. Coates. Yes.
Senator Isakson. For all VA facilities?
Ms. Coates. Yes.
Senator Isakson. You have a complaint process, is that
correct?
Dr. Daigh. Yes, sir, we do. We have a hotline process that
is very active.
Senator Isakson. You mean you get a lot of calls?
Dr. Daigh. Yes, sir.
Senator Isakson. Do you have the personnel necessary to
follow up on those calls?
Dr. Daigh. I am not sure. We have the capability and
publish about 50 hotline reports a year. We get several
thousand calls either by email or telephone a year. Many of
those, we refer back to VHA's management one level above the
level of the complaint. The most serious ones, we address in
writing and publish on our Web site.
Senator Isakson. To your knowledge, were all of the
instances of infection in these three facilities self-reported
by the facilities or did they come to you by virtue of the
hotline?
Dr. Daigh. In this case, all three were self-reported
through VHA systems, not primarily through us.
Senator Isakson. Well, I think that is an important quality
fact. We do not want any mistakes to take place, but we do want
to have a culture that when a mistake does take place, we take
immediate action from a standpoint of the specific case, and
also--it would seem like in this CAP program--that I would be
working as fast as I could to have procedures in place so every
future inspection would address the disinfecting program on
this type of equipment in the hospital.
Dr. Daigh. Could I comment, sir?
Senator Isakson. Yes, you can.
Dr. Daigh. We have been asked, and will in 90 days, do a
follow-up inspection on this topic. And it has been our general
observation that when things are really on the front burner and
everybody is aware of it that VHA then will pay attention to
it, and I think it is often important to follow up--down the
road when the light has moved off that a little bit--to look
closely at not only the reprocessing of endoscopes but
reprocessing of reusable medical equipment. So, we will look at
it and take a serious long-term look at this.
Senator Isakson. Thank you very much, Mr. Chairman.
And, Mr. Chairman, if I can, I want to apologize to Rebecca
Wiley on the second panel, that I may not be back. I do not
want her to consider that local hometown boy not coming back,
but I am on the Health Care Committee markup and I have to get
back there this afternoon. Thank you, Mr. Chairman.
Chairman Akaka. Thank you very much for being here, Senator
Isakson.
Now we will hear from Senator Johanns.
Senator Johanns. Thank you very much, Mr. Chairman.
Let me, if I could, start out with the Inspector General
here. The first thing I would like to say is how much I
appreciate your work.
As you know, I was the Secretary of Agriculture, where I
worked with an Inspector General, and I always found that her
work was very, very professional. I will tell you that some of
the gray hair I have came from the various reports, but I do
appreciate the work.
I quoted from your report here where it said the failure of
medical facilities to comply on such a large scale with
repeated alerts and directives suggests defects in
organizational structure. What drew my attention to that was,
unfortunately, there can be cases where an employee is not
paying attention for whatever reason. Maybe they have had a bad
day or a bad night or whatever, and something goes wrong, and
that is deeply as tragic. But it does not imply what you are
implying here.
Talk to me a little bit about that conclusion; why you
think that in fact is the case; and then I would like you to
just give me two or three or four, whatever, bullets on how you
fix that. If it is really a structural problem here, what is
your recommendation in terms of how to deal with that?
Dr. Daigh. So, in response to your question, I do believe
it is a structural problem. There are, I believe, at least
several instances we have been dealing with where a directive
goes out from VACO to the field on things that I think are
important wherein compliance is not what one would expect. And
so, I do find that to be an issue.
I think that the solution to the problem--and let me also
say that the current structure of VA, I think, has produced a
wonderful health care system that produces very high quality
care. It also has produced a medical record, and I think an
excellent culture of safety. I believe the ladies and gentleman
behind me have done a wonderful job with that.
I think the problem, though, now is to stamp out variation
in delivery, so that every time you deliver care it is
excellent care.
And there are parts of health care that require intellect
and thought and planning, and I think those need to be very
carefully preserved. But there are parts of health care that
are a process, almost an industrial process. You order an x-ray
of the chest that needs to be done correctly, timely, and
reported correctly.
And I think that it is time to take a look at whether the
current variety of organization within hospitals--some
hospitals have a Department of Surgery, a Department of
Anesthesia; some hospitals have a Surgical Care Line. So, I
think the people need to sit down and think about what
organization would best allow us to drive out the variation,
and I think that is the troubling part.
You have wonderful population metrics and variation that
troubles us. The variation can never be driven out, but I think
there are some significant steps to do that.
I also think the talent exists within VHA to do that. I
think that the people behind me understand that, recognize
that. I just would encourage that we move out on that topic.
Senator Johanns. I think the report is very thorough. We
can read that. We can understand, man, something really went
wrong here.
If there is anything I would ask as your office is working
to try to assist a structural change here that does what you
are suggesting--and I agree these things have to be done
routinely and well each time--is to let us know if this is not
being overcome, because if it is not being overcome then you do
have a serious problem. You have got a serious management
issue. You have got a serious issue in terms of how management
is driving this message down to the actual care level, and that
is what we need to know.
Like I said, everybody understands a variation. We do not
want to see it ever, but we can understand it. But if what is
happening here is variations are occurring because the message
is not getting down to the care level in terms of what to do,
how to do it, and when to do it, then that is a very
significant issue because this problem will not go away. It
will just continue to repeat itself over and over.
Then the final thing I wanted to say, Mr. Chairman, is
this: what worries me about the structural issue in your
finding here is what else is happening. You know what I am
saying?
If there is a structural issue in the organization, I doubt
that you just happen to stumble onto the problem that it was
causing. I worry that there are other issues out there that you
have not been asked to look at or you have not looked at or
audited or whatever, that are going to be the subject of
another hearing and another hearing. So I am hoping you will
somehow keep us apprised of what we are dealing with and
whether you are seeing the change that needs to occur to solve
the problem.
Senator Burr [presiding]. Thank you, Senator Johanns.
I am going to recognize myself. You have not voted, have
you?
Senator Johanns. I think we have. Have we been called to a
vote?
Senator Burr. We have been called to a vote. You need to
leave.
Senator Johanns. I need to get out of here and vote.
[Laughter.]
Senator Burr. I will try to fill in until the troops, the
cavalry come back.
To those of you from the Inspector General's Office, in
your report, you detailed how in the wake of the January 2006
event with reprocessing of prostate biopsy devices VHA had
conducted a national review to assess compliance with
reprocessing standards. You mentioned that all VHA facilities
conducted self-assessments, and the aggregated results were
published in 2007. Tell us what was found to be the main
conclusions from those assessments.
Dr. Daigh. I did not review the conclusion. I do not know
the answer to that.
Senator Burr. In the course of the investigation, did you
find that the VA had used the results in a constructive manner?
Dr. Daigh. I think that the litany of notification to
facilities that this is a high-risk area and the fact that
there had been self-reporting of lack of following the
directions at quite a number of facilities led us to the
conclusion that we needed to take a hard look at what was going
out universally. So we then had the unannounced inspection to
try to determine whether compliance was systemwide or not.
Senator Burr. You know what I am asking here. It is sort of
impossible to assess what and if VA took a constructive step in
the right direction if in fact the IG did not even look at what
the reviews were that came back from this internal process.
I am trying to give the VA a fair opportunity to detect
what was wrong and begin to try to fix it. Whether that was a
structural change, I think is in question. But is there any
reason for me to believe that from the information they gleaned
in the 2007 self-assessment, that they learned something and
acted on it?
Dr. Daigh. I would say that the fact that there were the
incidents we described in the report--that would be Miami,
Murfreesboro, and Augusta--the repeated notifications of
failure to properly reprocess ENT scopes at several other
sites, the 16 or so sites who indicated that they were not
following all of the directions with respect to reprocessing
led us to the conclusion that whatever had happened before was
not effective at the current time. And so, I think that the
facilities did not recognize this to be the high-risk area that
it was or, as we go through the recent events, there should
have been a facility or two that had a problem, but there were
quite a number of facilities that had reprocessing problems.
Senator Burr. So, in other words, the medical alerts that
went out were ignored or devalued from a standpoint of
importance?
Dr. Daigh. I think that it was not appreciated that
multiple alerts about the same problem or series of problems--
not exactly the same issue--set up a situation where
reprocessing of these instruments was a high-risk area that
needed more than just casual oversight because of the risk
involved in them. Otherwise, there would not be so many
recurring alerts about these topics.
Senator Burr. Last week, you released a report evaluating
VHA's National Patient Safety Program. I am sort of curious.
When conducting analysis with a national safety program, you
made no mention of the multiple alerts that were ignored with
respect to endoscopy. Can you share with me why?
Dr. Daigh. The issue that we were looking at there was
whether we thought the effectiveness of that organization could
be improved or not, and we did not specifically look at the
endoscopy alerts at the time that we did that report.
I should say that about 2 years ago we conducted an
unannounced review of VHA to see whether or not the facilities
had complied with the National Patient Safety Alert which dealt
with the recall of cadaver material to be used in surgery. So
an alert went out. We then, after a period of time that we
thought appropriate for VHA to respond, had a similar
unannounced inspection. We published that report, and VHA did
extraordinarily well. We thought they had complied very well
with that patient safety alert.
So, from my point of view, I thought the alerts were, in
fact, being addressed reasonably and that people were
responding to them. So these unannounced inspection results are
a surprise to me, that we found the answer that we did.
Senator Burr. I guess I am having a little disconnect
because in the previous question you suggested they were
ignored. Yet, in this process, the alerts were not important to
come to a determination about. Is that what I understand?
Dr. Daigh. I am suggesting that. Yes.
Senator Burr. Have there been any personnel actions that
have been taken throughout VHA in response to any of these
mistakes, to your knowledge?
Dr. Daigh. I am aware of a variety of administrative board
actions. I am unaware of the outcome of that human resources
effort. So, I think the second panel could much better speak to
what actions have been taken or not been taken, but I am aware
that there have been efforts along that pathway.
Senator Burr. Now the VA has maintained that it is very
transparent when it comes to its disclosure of adverse events,
even more so than the private sector. But in your June 18
report, you detailed that during your 2007 VA facility reviews,
``We assessed adverse event disclosure and reported weaknesses.
We reported that only 54 percent--21 of 39 facilities--had
completed full disclosure.''
Given these facts, what is the IG's opinion of the VA's
level of transparency both with respect to this specific
situation as well as the overall VA health care system?
Dr. Daigh. Let me say that the disclosure policy the VA
has, I think, leads the country in terms of the requirement to
disclose to patients when events occur that are not life-
threatening, when events occur that are life-threatening, and,
as a third category, when events occur that require the
disclosure to a large number of people.
And I believe that when you go back and look at the
disclosures that have been made--and in this case VHA
identified the problem and then disclosed to the affected
patients that there was a risk--I think VHA has been very
forthright in their disclosure, both with respect to the
prostate issue and with respect to this current problem.
Senator Burr. Dr. Nolan, relative to proper sterilization
or disinfection of reusable devices, how many lives need to be
at risk before this is a medical problem?
Mr. Nolan. Well, any one death or injury is one too many.
In the Quality Chasm report, Joseph Juran pointed that out.
Senator Burr. How about from a standpoint of infection? How
many Hepatitis B or HIV before this is a medical problem?
Mr. Nolan. The goal is zero, clearly.
Senator Burr. That is sort of the way I look at it.
In conducting the random site visits during the course of
your investigation, you visited 42 hospitals specifically to
evaluate their procedures, if I am correct. You excluded Miami,
Murfreesboro, and Augusta from the review because you said
separate detailed onsite inspections were taking place there. I
take for granted you meant by the IG's office?
Dr. Daigh. Yes. Victoria Coates went to all three of those
sites.
Senator Burr. Could I ask you or her to give more details
about what the IG is doing to ensure the safety of our veterans
at those facilities?
Dr. Daigh. I think that what we have done is identify
clearly to the management of those facilities the defects that
we found, and have strongly encouraged that they comply with
the standards that are written which should be followed.
We will also have a follow-up inspection, within 90 days,
of VHA's facilities to assess the system's response to this
directive.
We will also incorporate into our CAP process a look at
aspects of reusable medical supplies so that this does not go
away in 2 or 3 months; that we continue to track this until we
are comfortable that everyone has the message and that that is
being done well.
I do not have the power to tell people exactly how to
change their process or to make personnel changes. We point out
to management what we find as problems and ask management to
respond.
Senator Burr. Mr. Chairman, I am nearly done, but I just
want to follow this up.
Chairman Akaka [presiding]. Sure.
Senator Burr. At what point--and I am talking about these
three facilities and the continuing inspections--at what point
would you determine it is appropriate for the IG to release
something versus for this to be internal between the IG and the
VA in hopes that this might be remediated; or are the results
of your initial findings made public?
Dr. Daigh. I would consider this a hotline in our records.
So, from my point of view, Congress and the Secretary asked us
to look at this issue, and so on my books this is a hotline.
Every hotline that I accept I either publish on our Web
site--and I would say that that is fully 80 percent of all the
hotlines we accept--and then there are a few, say maybe 10
percent or 20 percent, where the allegations are completely
unsubstantiated, and to publish a series of allegations that
are serious and unsubstantiated I think is not in the public
interest.
Senator Burr. I would agree.
Dr. Daigh. And I close those administratively.
We have occasionally been asked by Members of Congress
about those cases, those hotlines, and then we respond
appropriately with respect to that. But, if my office accepts a
report, we put it on the Web.
Senator Burr. I guess my direct question is having noted
those deficiencies in those three facilities, at what point
would it trigger you to take a more aggressive stand relative
to VA's remediation of the deficiencies?
Dr. Daigh. I think that if--yes, I think----
Senator Burr. Does it happen voluntarily on your part or
does it require us to ask you?
Dr. Daigh. No, no, no. I think what you are asking is at
what point would I call the Under Secretary for Health and say,
we need to do something very quickly and very seriously
systemwide to address the issue.
Let me say that if what we had done in our inspection was
to actually pull scopes off the wall and inspect them for
whether or not they were properly cleaned and in proper
condition to be used, and if I had found in that circumstance
that the scopes were not appropriate, I would have called and
said that patients are clearly at risk.
The review I did looked at administrative compliance. Did
you have the SOP there? Did your training records reflect that
folks were trained? That is close to saying that things are not
going well, but that is not the same as saying that patients
are actually at risk.
There are instances where I become aware through the
hotline process that patients are at risk. I routinely pick up
the phone and call Dr. Cross in either his current or his prior
role, and the response has always been immediately trying to
take steps to make sure that that risk is immediately
mitigated, and that we can then work to figure out what the
facts are and how to move forward.
So, I would say over the last 5 or 6 years I have had this
job I have had that discussion a couple of times a year at
least with the Under Secretary, the Deputy Under Secretary, or
the Chief of Staff of VHA, and it has always been a very
professional: What do we need to do to try to make sure that
veterans are not harmed?
Senator Burr. I thank you.
I thank the Chair.
Chairman Akaka. Thank you very much, Senator Burr.
I want to thank this first panel very much for your
testimony. It is good to hear from the Institute, the
Commission and also the IG's Office on this.
We, without question, want to maintain the quality or raise
the quality of what we are doing for our veterans, and the
bottom line is our veterans' well being. We must take greater
measures to ensure these problems do not recur.
So, I want to thank you all for what you are doing and look
forward to working with you. Thank you very much.
Let me introduce the second panel. We will hear from Dr.
Gerald Cross who is Acting Under Secretary of Health. He is
accompanied by Dr. William Duncan, Associate Deputy Under
Secretary for Health, for Quality and Safety.
Also, we have medical center directors from Murfreesboro,
Tennessee, Augusta, Georgia, and Miami, Florida, to respond to
questions. VA originally identified problems with the cleaning
of endoscopes at these facilities.
Dr. Cross, thank you very much for being here. Your full
testimony will appear in the record and we look forward to your
testimony. Will you please begin, Dr. Cross?
STATEMENT OF GERALD M. CROSS, MD, FAAFP, ACTING UNDER SECRETARY
FOR HEALTH, VETERANS HEALTH ADMINISTRATION, DEPARTMENT OF
VETERANS AFFAIRS, ACCOMPANIED BY WILLIAM E. DUNCAN, MD, PhD,
MACP, ASSOCIATE DEPUTY UNDER SECRETARY FOR HEALTH FOR QUALITY
AND SAFETY; JUAN A. MORALES, RN, MSN, DIRECTOR, VA TENNESSEE
VALLEY HEALTHCARE SYSTEM; REBECCA J. WILEY, DIRECTOR, CHARLIE
NORWOOD VA MEDICAL CENTER; AND MARY D. BERROCAL, MBA, DIRECTOR,
MIAMI VA HEALTH CARE SYSTEM
Dr. Cross. Mr. Chairman, my comments were written in regard
to the original hearing topic which was quality management. I
am now including comments on quality management, but also
endoscopy and brachytherapy.
Nothing that I am going to say reflects any defensiveness
or satisfaction, and, if you hear any hint of pride about our
overall programs, you will hear nothing but humility and
determination in regard to any errors in patient care. My
focus, my team's focus, our foremost and always focus is the
patient's well-being.
VA health care is dedicated to caring for our most honored
citizens. Today's challenge for VA health care is consistency--
consistency at all sites of care. In other words, while overall
quality is above average, a few of our 1,400 facilities have,
on occasion, performed poorly on some aspects of care. I am
referring to the VA sites that self-reported systemic problems
with their endoscopy reprocessing or brachytherapy treatment.
In the vast majority of cases, VA's experiences and
achievements have had an extremely positive impact on national
health care and VA will continue to play a key leadership role
in the success of our Nation's health care future.
There are several reasons for it. First, VA trains a large
number of our Nation's health care workers--about 100,000
health care workers per year. Second, our research has provided
significant proportion of our Nation's medical research
advances. In the past 7 years, VA authors and co-authors have
published more than 46,000 articles, contributing significantly
to the world's library of medical knowledge; and that is just
the beginning.
VA also is the innovator of several of the tools that our
Nation will need to support health care delivery improvements.
For example, VA has developed creative techniques to
dramatically lower the cost of purchasing and distributing
medications. Our performance management system also holds our
senior clinical and administrative leaders accountable for
achieving evidence-based quality targets and has led to
dramatic improvement across our health care system.
At VA, we have seen time and again that quality and
innovation go together. Perhaps one of the most famous
innovations is our world-class electronic health record. The
use of the electronic health records for all of our patients
led to soaring improvements in quality of care over the last
decade.
VA innovations enable us to provide superior care to
veterans we treat. For example, we developed a new system of
health care such as our National Polytrauma System of Care,
telemedicine and teleradiology. We are looking beyond
traditional hospitals to a new concept: health care centers
that will meet the vast majority of patient needs without the
expense of a large inpatient facility. Our NSQIP program, that
stands for National Surgical Quality Improvement Program, which
monitors surgical quality is so successful that it has been
adopted by others including the American College of Surgeons.
Mr. Chairman, I provided you and the Members of the
Committee a few slides which demonstrate the current state of
VA health care quality, which I believe is unmatched in the
Nation today. These slides permit a quality base comparison
between VA results and others. The slides demonstrate VA's
exceptional record with regard to preventive health care
including screening for cholesterol, cancer and diabetes.
Patients report high levels of satisfaction with the care
they receive, whether inpatient or outpatient facilities, and
the medical literature documents these accomplishments. For
example, after accounting for the burden of chronic illness,
risk-adjusted mortality for older VA patients was almost 30
percent lower than patients enrolled in Medicare Advantage.
This was published by Dr. Alfredo Selim's research in the
Journal of Medical Care in April 2006.
If you have any specific questions about these slides, I
look forward to discussing them after my oral statement.
As the Nation moves to its health care future, ethics
policies, such as those developed at VA, should serve as a
foundation for organizational responsibility. We have a strong
policy of disclosure when we do something wrong. We disclose
our errors publicly because we believe it promotes the trust of
our patients. We believe it is the right thing to do. It may be
painful, and I can assure it is in the short term, but it is
the best thing for everyone, particularly for our patients, in
the long term.
This policy of disclosure has been put to the test several
times. Recently, we discovered that several of our facilities
were not following manufacturer instructions for the
reprocessing of endoscopes. Last year, we discovered problems
with the dosing and follow-up for brachytherapy patients.
When we found these problems and determined that there was
a potential risk to patients, we took action. We informed
Members of Congress. We put information on the internet. We met
with veterans service organizations. We contacted patients to
come in for special follow-up with respect to endoscopy. And,
with respect to endoscopy, we engaged the Inspector General's
Office.
What is more, we implemented a corrective plan that goes
beyond endoscopy to address more broadly how we use all
reusable equipment and how it is handled. The plan focuses on
training. It focuses on standardization, and it focuses on
oversight. Further, we have devoted additional funding just as
of this week, about $26 million, to upgrade reprocessing
equipment. We have been working on that plan for some time.
In regards to brachytherapy, reviews of the program at the
Philadelphia VAMC, my external experts gave our program high
marks. Yet, when we noted problems, I directed a review of all
sites--not just Philadelphia--but all sites providing this
therapy. We hired a highly regarded radiation oncologist to
review our practices, and all of this followed an external
assessment in August 2007 by the American College of Radiation
Oncology in which the brachytherapy program reviewer gave the
quality assurance program high marks and described one portion
as the best I have seen on any site visit.
In any case of medical error, our foremost priority is to
work with individual patients to acknowledge errors when they
occur and to do all that we can for each patient. We are
committed to holding our staff accountable for their
performance. VHA must ensure compliance with SOPs and encourage
those who raise concerns about the quality of care. We need to
encourage them and reward them.
Our patient safety program depends on both external
oversight and internal self-reports. When our staff members
feel that they can bring problems forward, we are more likely
to hear about those problems. That is why we foster a culture
of self-reporting.
Conclusion: In conclusion, Mr. Chairman, quality and
innovation are important to our Nation's health care future. VA
will continue to lead the Nation in these areas. But when
problems occur, ethics, disclosure, and accountability also are
vital to our veterans' trust and our veterans' care.
Thank you, sir.
[The prepared statement of Dr. Cross follows:]
Prepared Statement of Gerald M. Cross, MD, FAAFP, Acting Under
Secretary for Health, Veterans Health Administration, U.S. Department
of Veterans Affairs
Mr. Chairman, Ranking Member Burr, and Members of the Committee:
Thank you for providing me this opportunity to discuss the Department
of Veterans Affairs' (VA) quality management and safety programs, as
well as the facts and circumstances surrounding recent gaps in the
reprocessing of endoscopes and how VA's quality management programs
responded to this situation. I am accompanied today by Dr. William E.
Duncan, M.D., Ph.D., MACP, Associate Deputy Under Secretary for Health
for Quality and Safety; Juan Morales, Director of the Tennessee Valley
Healthcare System; Rebecca Wiley, Director of the Charlie Norwood
(Augusta) VA Medical Center; and Mary Berrocal, Director of the Miami
VA Healthcare System.
Before reviewing the details of the recent shortfalls in VA's
endoscope reprocessing at several of its medical centers, I will review
the quality management organizations and activities in place. Quality
management is fundamental to VA health care, which exists solely to
serve our Nation's Veterans. Professional publications and the
mainstream media have recognized and lauded our accomplishments in
providing the best integrated health care in the country. These
achievements are possible because of VA's ability to link four
fundamental elements of health care delivery: access by eligible
Veterans, regardless of pre-existing condition or ability to pay;
systems of care, such as primary care and community-based long term
care coordination that focuses on the whole patient; a comprehensive
electronic health record that follows the patient throughout the
continuum of care; and systems of performance measurement that ensure
consistently safe, high-quality health care. Despite caring for
patients that are, on average, sicker, older, and less affluent, VA
health care compares favorably with the best U.S. health care systems.
VA maintains broad and robust quality management and safety
programs that incorporate multiple components, including improvement
activities, patient safety reporting and analysis, internal and
external reviews including accreditation by recognized professional
groups, performance management, close monitoring of patient care
experiences, evidence-based clinical guidelines, utilization
management, risk management activities, and a systematic approach to
process improvement and redesign. VA tracks more than 250 measures and
monitors that are routinely used to evaluate processes and outcomes of
care, as well as to hold its senior administrative and clinical leaders
accountable. Some examples of these measures include breast and
cervical cancer screening, diabetes exams, hypertension screening,
smoking cessation counseling, immunizations and the use of beta
blockers after a heart attack. Based upon standard benchmarks from
other Federal systems and the private sector, the Veterans Health
Administration (VHA) has consistently improved its performance annually
for the past decade on nearly every measure and VHA's performance
equals or exceeds the average for commercial health plans, Medicare and
Medicaid. Veterans' perceptions of care provided by VHA likewise equal
or exceed those in the community on standard measures of patient
satisfaction. VA provides this information online
(www.qualityofcare.va.gov/home.cfm). This Web site provides information
on 10 quality measures at the facility, Veterans Integrated Service
Network (VISN), and national levels and compares VA's performance with
other providers; on all 10 measures, VA outperforms its counterparts.
My testimony today will describe how VA has centralized quality and
safety management, how it turns measurement into action, and discuss in
detail how VA identified problems in some of its facilities concerning
the reprocessing of endoscopic equipment, including how VA began and
continues to notify patients, and what remedies it has adopted in
response to these incidents.
centralizing quality and safety management
VA has long been a leader in measurement of quality and
performance. Our current Performance Measurement System began as the
External Peer Review Program in 1992, focusing primarily on compliance
with evidence-based guidelines for inpatient and outpatient care. Even
prior to that, the Continuous Improvement in Cardiac Surgery Program
(founded 1987) and the National Surgical Quality Improvement Program
(1991) developed some of the first tracking systems for risk-adjusted
surgical mortality and morbidity to provide VA a comprehensive quality
assurance program for surgical services.
VA established the Office of Quality and Safety on November 16,
2008, to better align and integrate ongoing quality and safety
activities and to provide senior leaders with trustworthy analysis of
quality data and monitors from multiple sources in order to drive
improvement and transformation throughout VHA. This new Office also
provided a mechanism to ensure that quality and safety indicators
across multiple measurement approaches were being routinely analyzed
and trended. This Office consists of three units: the National Center
for Patient Safety, the Office of Quality and Performance, and the
Quality and Safety Analytics unit.
VA's National Center for Patient Safety (NCPS) has been in
existence since 1999. NCPS takes a systems approach to patient safety
that is adapted from known high reliability organizations such as
aviation or nuclear power. These system-level interventions include
safety engineering tools (e.g., Root Cause Analysis, Healthcare Failure
Mode and Effect Analysis), checklist and template-driven approaches to
standardizing care processes (e.g., Patient Daily Plans, Universal
Protocols to Ensuring Correct Surgery and enforce Hand Hygiene
guidelines), and leadership training (e.g. Medical Team Training). High
reliability organizations align all their activities to create an
organizational mindfulness of safety. VA accomplishes this through a
national, externally validated, organizational safety culture survey.
NCPS utilizes reports of adverse events and ``close calls'' from
facilities to identify vulnerabilities that require intervention.
``Close calls'' are those events that did not result in significant
harm but identified vulnerabilities that, under other circumstances,
might have resulted in harm. One measure of the dissemination of
safety-mindedness is the continued growth in self-reported adverse
events and close calls. Since its inception, NCPS has conducted
Aggregated or Individual Root Cause Analyses that targeted over 425,000
adverse events and close calls. Dozens of countries around the world
recognize this system of analysis and monitoring as a benchmark and
have adopted it for their own health care systems.
VA's Office of Quality and Performance has, since the 1990s, been
responsible for assessing patient experiences and satisfaction;
measuring, analyzing and reporting on VA's performance; identifying and
promoting evidence-based practices; monitoring accreditation of
facilities and programs, physician credentialing and privileging, peer
review and risk management; and supporting utilization management.
Since 2006, VA has used the Survey of Healthcare Experiences of
Patients to track patient satisfaction. This year, VA selected a new
contractor and a new instrument, the Consumer Assessment of Healthcare
Providers and Systems (CAHPS), to measure patient satisfaction. The
Agency for Healthcare Quality and the Centers for Medicare and Medicaid
Services developed the CAHPS, which has been widely adapted by other
health systems. VA made this shift because the CAHPS is a shorter
survey, has a wealth of research already available, will improve
turnaround reporting of fully adjusted and weighted satisfaction
information to the field, and allows benchmark comparisons with private
and other Federal health care organizations. Early results suggest VA
is outperforming the private sector. Similarly, the American Customer
Satisfaction Index has shown VA performance to be superior for hospital
and outpatient care in each of the last 5 years.
VA's newest organization, the Office of Quality and Safety
Analytics, compiles and analyzes quality and safety data from multiple
sources and supports education and training of quality management
professionals across all of VHA. This unit is the outgrowth of a
national Inpatient Evaluation Center (IPEC) program begun in 2005 to
measure and report risk-adjusted medical or surgical care outcomes,
including length of stay, use of intensive care units, and rates of
complications such as central-line associated bloodstream infections,
ventilator associated pneumonia, and venous thromboembolism. IPEC staff
generates quarterly reports for all facilities and are available to
facilitate onsite quality improvement efforts.
The Office of Quality and Safety seeks input from both internal and
external subject matter experts. Many of the country's leading experts
on these issues are VA clinicians, who serve on an internal advisory
committee. VHA also recently participated in the Institute for
Healthcare Improvement's ``5 Million Lives'' Campaign.
from measurement to action
VA has set the national standard for quality measurement and
transparency, but measurement alone is not enough--action is also
needed. Last year, VA issued Quality Management Program Directive 2008-
061, which emphasized the critical responsibility of facility, VISN,
and national leadership to ensure health care is safe, effective,
patient-centered, timely, efficient and equitable. It designated that
leaders must have accountability structures in place, must understand
and be able to articulate the flow of quality management within their
organizations, and must take responsibility for identifying,
prioritizing, and coordinating improvement activities within their
organization. VISNs were tasked with doing an annual evaluation of the
Quality Management Programs at their facilities, developing action
plans for identified deficiencies and tracking these until they have
been corrected. Networks and facilities are held accountable for these
measures in their performance plan; the Deputy Under Secretary for
Health for Operations and Management conducts quarterly reviews with
Network Directors to review their progress. Additional interventions
may be triggered by specific circumstances--for example, the
appointment of any VHA physician who meets identified malpractice
triggers is subject to mandatory review by the VISN Chief Medical
Officer. Facilities with special concerns can also undergo a detailed
Analytic Site Review coordinated through the VISN office and conducted
by staff from the Office of the Associate Deputy Under Secretary for
Health for Quality and Safety. These comprehensive assessments attempt
to identify areas of concern by linking and analyzing over a thousand
quality metrics in multiple domains. Follow up site visits by teams of
experts are often initiated as a result.
VA is committed to improving systems and redesigning them when
necessary to improve the care delivered to patients by engaging front
line staff in productive and meaningful changes. A national approach to
process improvement and redesign, known internally as Systems Redesign,
is adapting approaches such as Six Sigma, Lean Thinking, and
International Standards Organization (ISO) Quality Management Systems,
all of which are proven tools in highly complex and high reliability
organizations, to tackle some of the most challenging problems in
health care, including optimizing use of staff and beds to avoid delays
in emergency rooms, operating rooms, and intensive care units; ensuring
critical laboratory values are brought to the attention of clinicians
responsible for the care of patients immediately; and making care
transitions and handoffs--such as when a patient transfers between
hospital units, or is discharged home--as safe as possible. We are
hiring systems improvement professionals and aligning them with our
executives because quality improvement can only be sustained if it is
supported by top leadership. We are also establishing our first four
Veterans Engineering Resource Centers because these partnerships with
the Nation's leading schools of engineering will bring critical
insights from disciplines not typically used in health care settings.
These perspectives have particular value in analyzing complex,
recurring processes such as the sterile reprocessing of medical and
diagnostic devices.
High quality care also demands attention to everyday activities,
such as improving hand hygiene practices to reduce health care
associated infections and other efforts to prevent the spread of
Methicillin-Resistant Staphylococcus Aureus (MRSA) in hospitalized
patients. VA's MRSA prevention program has had a significant impact on
infection rates, transmission rates, and has been recognized as a
national model. Falls and pressure ulcers are among the most common
inpatient adverse events, particularly for older patients, and have the
potential to greatly extend a hospital stay. VA is deploying special
programs to assess and reduce the risk of falls and skin breakdown in
hospitals across the country.
Another routine task is the process of verifying the training,
licensure, and employment of all licensed, registered and certified
health care professionals in VHA, including nearly 55,000 licensed
independent practitioners and 70,000 non-independent professionals. VA
continually improves its process for credentialing and privileging
health care providers to ensure VHA clinicians meet the highest
possible standards. Last year, VHA enrolled all licensed independent
practitioners in the National Practitioner Data Bank--Health Integrity
and Protection Data Bank Proactive Disclosure Service, which ensures
immediate notification of medical malpractice payments and adverse
actions. To ensure VA is aware of any actions taken against a physician
for all current and previously-held licenses, we monitor physician
licensure through the Federation of State Medical Boards' Disciplinary
Alert Service. We also obtain confirmation from the Federation of all
licenses currently or previously held by all physicians who work for
VHA (employees and contractors).
VA has an exceptional program for ensuring patients receive the
right medication, in the right dose, at the right time through its
patient-centric electronic health record (EHR). VA's EHR is supported
by the Computerized Patient Record System (CPRS), electronic medication
order entry, and direct prescription into Pharmacy Vista and the Bar
Code Medication Administration (BCMA), which has become the model for
the private sector and foreign countries alike. The EHR also
automatically checks for allergies or possible drug interactions,
further improving patient safety and care. VA's Center for Medication
Safety (VAMedSAFE) is a national, comprehensive pharmaco-vigilance
program that emphasizes the safe and appropriate use of medications.
VAMedSAFE utilizes different methods and tools, including passive and
active surveillance, to continuously monitor for potential adverse drug
reactions. In many instances, VAMedSAFE directly and promptly notifies
providers across VA's health care system if patients are at risk. VA
has a Memorandum of Understanding with the Food and Drug Administration
(FDA) that allows close collaboration on specific post-marketing
surveillance efforts and other drug and vaccine safety projects. These
efforts are conducted through FDA's newly established Sentinel
Initiative and the Office of Surveillance and Epidemiology's Center for
Drug Safety and Epidemiology Research. Medications and prescriptions
are essential to effective health care management, but inaccuracies can
have severe repercussions. In 2008, VA provided approximately 130
million prescriptions to more than 5 million patients. Our error rate
for these prescriptions is less than 1 in every 294,000, significantly
better than the private sector.
endoscope reprocessing
Legitimate questions have been raised about the overall quality and
safety of VA's care due to inadequate reprocessing of fiber-optic
endoscopic equipment at some of its facilities. VA's number one
priority is the well being of our Nation's Veterans, and we deeply
regret these incidents occurred. Our Veterans were willing to make the
ultimate sacrifice and they deserve the best possible care, at every
facility that we operate. We have an obligation to provide them a safe
environment in which to receive medical care. Veterans and their
families need to feel confident that when they come to VA they are in
good hands and that they are being provided consistently safe, high-
quality health care. As this incident shows, however, we must
consistently challenge ourselves to remain diligent stewards of leading
health care initiatives and services.
Leaders in health care quality have long recognized the challenges
of maintaining high reliability across complex activities such as
endoscope reprocessing in the face of production pressure. Although we
are not able to provide comparison rates for reprocessing discrepancies
in non-VA health systems, it is important to emphasize that a
cornerstone of VA's quality and safety programs is a commitment to
identifying problems, identifying any patients at risk, disclosing any
problems to them, and offering appropriate testing, counseling and
treatment. The reprocessing issues identified at our facilities were
identified by VA employees committed to quality and safety, and we have
kept Veterans Service Organizations, the media, and Congress informed
about this issue as new facts become available.
Secretary Shinseki has made accountability and transparency top
priorities for VHA and for the entire Department. It is unacceptable
that this has happened and the Secretary directed aggressive action to
inform, test and support our patients. We will use this unfortunate
experience to understand how we can transform our Department. VA is a
results-driven organization that learns from its mistakes. Everyday we
need to push ourselves to better serve and care for our clients--
Veterans.
The Secretary has demanded that we continue to rigorously monitor
this situation. Our next step is to utilize the findings of these
investigations to implement necessary corrective actions in a firm,
responsible fashion. We will do this while continuing to maintain an
environment that encourages all staff to identify concerns that impact
the care and safety of our Veterans.
In relation to the inadequate processing of endoscopes, that is,
those steps taken to disinfect at a high level endoscopic equipment and
prepare it for further use, VA has taken local and national actions to
better understand how this could happen and to ensure it does not
happen again. We are committed to an open and honest assessment of our
policies and procedures. While we never want to worry patients
unnecessarily, we believe patients have a right to know about important
information that could potentially affect their health. VA's policy
requires disclosure to patients of any adverse events related to their
health care that causes or may potentially cause harm. VA has notified
patients about even those events that may not be obvious or severe or
those that pose only a minimal risk to a patient's health. The
probability that anyone was harmed as a result of our inadequate
reprocessing at these four facilities is very low.
The disclosures we are making to Veterans are based on the very
small potential for harm. At present, there is no definitive evidence
to suggest that the positive tests we have found so far are the result
of inadequate reprocessing of endoscopy equipment. In this country,
many adults who are infected with Human Immunodeficiency Virus (HIV),
Hepatitis B and C have not been tested and would not be aware that they
are infected. In recent weeks VA has been testing many patients who
have never been tested before. As a result, we would expect some of
these patients would test positive. No matter how low the likelihood
that any disease occurred due to suboptimal scope disinfection, VA will
care for patients regardless of the source of infection.
There were other facilities where there was inadequate reprocessing
of endoscopes but, after review, it was determined that the risk of
harm to patients at these facilities was so remote that it did not
justify informing patients.
background
Endoscopes are small diameter devices that allow a physician to see
internal organs through external orifices by utilizing a system of
optics. There are many different types of flexible and rigid
endoscopes. The endoscopes discussed below are inserted either through
the nose or mouth to visualize the esophagus, nasal passages, lung,
stomach and upper part of the small intestine, or they are inserted
through the rectum to visualize the colon. Some of these endoscopes
used for colonoscopies have an internal tube that allows the physician
to inject a stream of water through the endoscope to flush away any
material that might obstruct adequate visualization of the colon.
Flexible endoscopes are complex devices that need to be reprocessed
before they can be used again safely. Reprocessing procedures are
defined by the endoscope manufacturer and generally involve careful
cleaning of the entire external and internal surfaces with an
appropriate cleaner, brushing any interior channels, and subjecting the
entire scope to high level disinfection or sterilization as recommended
in the manufacturer's instructions.
discovering the problems
On Monday, December 1, 2008, at the Tennessee Valley Health Care
System, Alvin C. York (Murfreesboro) VA Medical Center (VAMC) in
Tennessee, VA staff observed during the third endoscopic colonoscopy of
the day a discoloration in the tubing that supplies water to flush the
colonoscope. They immediately realized that this presented a potential
problem to the patient and investigated further. Over the next 2 days,
staff determined they were not using a water irrigation tube with a
check valve designed to prevent contaminated fluid from the patient
from flowing back into the scope and irrigation water tubing. As they
investigated further, the staff discovered the Auxiliary Water Tube
(MAJ-855) had been altered with a different connector that was not a
one-way valve. In the process of examining the procedures for the use
and reprocessing of the colonoscope, the Murfreesboro staff discovered
that they were not changing and reprocessing the MAJ-855 in accordance
with the manufacturer's instructions.
The Murfreesboro staff reported these problems to the facility
Patient Safety staff on December 4, 2008, and the next day, to VA's
National Center for Patient Safety (NCPS). NCPS conducted fact finding
by evaluating the equipment and procedures used at Murfreesboro and by
closely working with the endoscope manufacturer.
Based on this work, a Patient Safety Alert (AL09-07) was issued to
the entire VA system on December 22, 2008. This alert requested that
all facilities determine they were using the correct valve and also
stressed that the manufacturers' instructions for all endoscopes were
to be exactly followed regardless of the brand. All facilities were
directed to determine if manufacturers' instructions were followed in
the use or reprocessing of flexible endoscope tubing and accessories
and to report any deviations to VA Central Office by January 7, 2009.
As a result of this alert, in early January 2009, 16 additional
facilities reported they had in some way not reprocessed their
endoscope water flushing systems in accordance with the manufacturers'
instructions.
It must be emphasized that failure to follow a manufacturer's
instructions does not necessarily result in significant additional risk
of cross contamination because the equipment is designed to have
redundant safety features. With this in mind, NCPS contacted the
manufacturer, which conducted tests to clarify what additional clinical
risk might accrue from the failure to follow its instructions. As a
result of these clinical and lab-based tests, the VHA Clinical Risk
Assessment Advisory Board (CRAAB) determined there was no appreciable
additional risk of cross-contamination if the only practice was
incorrect reprocessing of the MAJ-855 between patients. This
determination was made on February 6, 2009, following receipt of
results of the manufacturer's clinical tests. The CRAAB is a
multidisciplinary committee that makes recommendations to the Principal
Deputy Under Secretary for Health (PDUSH) as to clinical risk and
whether large scale notifications (disclosure) should be made to
Veterans.
The CRAAB concluded there was a very small risk of cross-
contamination if the MAJ-855 was not reprocessed between patients and
either (1) the proper check valve was not attached to the MAJ-855; or
(2) the clinician did not prime the MAJ-855 with water prior to
initiating the examination. Following the February 6, 2009, meeting,
the CRAAB, therefore, recommended disclosure only where either of these
two circumstances existed in addition to improper reprocessing of the
MAJ-855. Of the 17 VAMCs reporting noncompliance with manufacturers'
instructions, these circumstances existed only at Murfreesboro and
thus, the CRAAB only recommended disclosure to patients at this
facility.
VA has a formal process to evaluate clinical risks to patients when
a risk, and hence the need for disclosure, is not clear. The CRAAB
weighs the nature of the harm, the probability, severity, magnitude and
duration of the harm, and courses of action, and balances these factors
against the potential medical, social, psychological or economic
benefits or burdens to Veterans resulting from the disclosure itself.
On January 26, 2009, the Augusta VAMC informed VA Central Office of
a problem it discovered with reprocessing of its Ear, Nose and Throat
(ENT) scopes. These scopes are different from the colonoscopes used at
Murfreesboro. As a result of a personnel change in January 2008, ENT
scopes were not reprocessed in accordance with the manufacturer's
instructions. After reviewing the circumstances, the PDUSH decided that
potentially exposed patients should be informed.
To ensure all VHA facilities were reprocessing endoscopic medical
equipment correctly, on January 28, 2009, the Deputy Under Secretary
for Health for Operations and Management issued a memorandum requiring
all VAMCs performing any endoscopic procedures to conduct a review of
the set up and reprocessing of these devices. On February 9, 2009, the
Under Secretary for Health instructed all medical centers to conduct a
safety Step-Up Week from March 9 through 13, 2009, to focus facilities
on retraining staff on the proper use of all endoscopy equipment,
establishing easily tracked accountability chains for instrument
cleaning, and training all appropriate staff about standard operating
procedures.
On February 24, 2009, Mountain Home VAMC reported that ENT
endoscopes were not reprocessed in accordance with manufacturer's
instructions. On February 27, 2009, after reviewing the facts with the
facility and a group of experts, the PDUSH decided that disclosure to
patients was required. The facility notified its local congressional
delegation, local Veterans Service Organizations, and Veterans at
potential risk.
On March 4, 2009, in preparation for the Step-Up Week, staff at the
Miami VA Medical Center discovered they had erroneously reported in
January they were in compliance with the manufacturer's instructions.
Miami staff found that the water irrigation tubing was not correctly
reprocessed and that it was not consistently primed and flushed prior
to the start of the patient examination. While either one of these
omissions by themselves would not have resulted in increased risk to
patients, both practices together created a slightly increased
potential for cross contamination between patients. The CRAAB
recommended disclosure to affected Veterans, and the PDUSH agreed.
The official policy of VHA is that ``VHA facilities and individual
VHA providers have an ethical and legal obligation to disclose to
patients adverse events that have been sustained in the course of their
care, including cases where the adverse event may not be obvious or
severe, or where the harm may only be evident in the future.''
As a result of increased scrutiny of the reprocessing of medical
equipment within VHA, 10 VA medical centers, in addition to the 17
originally identified, have found reprocessing practices that were not
in compliance with manufacturer's instructions. At each facility where
we found a problem, we evaluated the situation to determine if
notification was required.
local response
Each of the four medical centers mentioned above took prompt action
to notify possibly affected Veterans; to offer testing, counseling and
needed treatment; and to identify and implement necessary procedural
changes to ensure the issues would not develop again. Other changes
varied among medical centers and are discussed below. Specifically,
each VAMC:
Identified Veterans who received endoscopic colonoscopies
or esophageal studies during the applicable date range and sent them
letters by regular or certified mail, return receipt requested. The
letters informed the Veteran they were potentially at risk and offered
testing for Hepatitis B, C, and HIV infection. Hepatitis B, C and HIV
were identified as the significant viral conditions which have the
potential to be transmitted via endoscopic cross-contamination. The
letter provided a toll-free telephone number to call to answer
questions or schedule testing.
Established and staffed call centers to respond to
questions from Veterans.
Established systems to track Veterans who were notified
and tested.
Established clinics to provide, on a priority basis,
testing and treatment as appropriate.
Instituted changes in staffing and processes as necessary
to ensure endoscopic equipment would be properly reprocessed according
to manufacturer's instructions.
At the Murfreesboro campus, staff identified 6,805 Veterans in
initial reports as having received colonoscopies between April 2003,
when VA first began using the affected equipment, and December 2008,
when VA discovered the issue. After conducting an intensive medical
record review to ensure all potentially affected Veterans were
identified, VA added 418 patients to the list for notification. VA
completed certified mailings to the first group by February 13, 2009,
while the second group was notified by certified letters sent May 8,
2009. Murfreesboro VAMC continues to search for Veterans whose letters
have been returned. The staff is using additional databases and general
Internet searches. VA is closely monitoring the results of this
outreach, and the records will continue to be updated. My oral
statement will include the most current information. As part of its
participation in the national Step-Up week in March 2009, the
Murfreesboro VAMC conducted an intensive review of the procedures for
reprocessing of all reusable medical equipment (RME), ensuring they
complied with manufacturers' reprocessing instructions. It also
conducted a Root Cause Analysis to identify and understand all
components of this issue, validated standard operating procedures
(SOPs), confirmed training of all clinical and support staff, and
verified staff competencies.
At the Mountain Home VAMC, staff identified 297 Veterans as
possibly affected by improper scope reprocessing that was not in strict
compliance with the manufacturers' instructions. All scopes are now
reprocessed by the facility's Supply, Processing and Distribution (SPD)
program. The facility has updated policies to require better
coordination among departments when RME is purchased and SOPs are
written. All staff members responsible for handling RME are trained and
certified. Training is noted in each competency checklist prior to
actual operations. Supervisors are responsible for maintaining
competency checklists and periodically validating adherence to
standards. All facility SOPs are aligned with the manufacturers'
written instructions.
At the Augusta VAMC, staff identified 1,069 Veterans who received
ENT procedures between January and November 2008. VA completed an
initial mailing of letters to these Veterans by February 10, 2009.
Additionally, VA released public service announcements with the help of
local media to further increase awareness among Veterans and family
members. VA staff called Veterans who had not contacted the VAMC in
response to the initial mailing. At the end of March 2009, VA sent 137
certified letters to patients who still had not made contact in
response to the initial mailing or who could not be reached by phone.
Of those letters, 128 were successfully delivered, one was declined,
and six were returned. Of the six returned letters, one was identified
as not deliverable because the patient was deceased. As of May 29,
2009, all but five of the 1,069 patients in the risk pool have received
mail notification, and we are continuing to attempt to locate these
five patients.
Augusta VAMC also conducted a Root Cause Analysis and, based on its
findings, took the following steps to improve medical equipment
reprocessing. First, reprocessing of RME was consolidated into the SPD
function. Construction also began on a new SPD station near the
gastrointestinal endoscopy suite. A multidisciplinary task force
ensured the ready availability of manufacturers' instructions for
reprocessing and that SOP and staff competency checklists matched those
instructions, revising where needed. VA re-trained all staff involved
in RME reprocessing and evaluated them using competency checklists.
Finally, the facility also increased use of the SPD Observational
Assessment Tool from once per year, as nationally required, to once a
month to ensure continued compliance with all requirements.
At Miami VAMC, VA identified a total of 2,609 Veterans through
medical record searches and reviews as having been possibly at risk for
cross contamination. VA began mailing notifications to all affected
Veterans March 23, 2009. After checking other databases for address
updates or changes, the facility sent a second certified mailing to
Veterans whose first letters were returned as undeliverable. Miami has
a particularly mobile population, so the facility undertook additional
efforts to locate Veterans who could not be notified by mail. These
measures included searches for alternate addresses on other VA
databases and commercial Web sites and multiple visits to homeless
shelters in the Miami area. The facility continues to attempt to locate
and notify remaining potentially affected Veterans.
Miami also reorganized its SPD program and realigned executive
leadership and line managers to make them accountable for reprocessing
activities. The facility added a Clinical Nurse Specialist to enhance
clinical knowledge in the line management function. It also reviewed
and revised competency definitions for all employees assigned to the
gastrointestinal clinic or to SPD to address proper equipment handling,
maintenance, use, and cleaning. VA conducted extensive training for
gastrointestinal technicians and nurses in proper equipment set-up and
pre-cleaning practices. Some of this training was done by
manufacturers' representatives, while some was done by sending staff to
other VAMCs. Facility leadership verified the competencies of all SPD
staff responsible for endoscope cleaning by April 7, 2009. Beyond this,
the facility established a continuing education plan, including
professional certification activities. By enhancing quality management
committees and establishing a VISN-level team responsible for
conducting unannounced inspections, VA continues to exercise effective
oversight of facilities and to preserve patient
safety.
va's national response
VA has taken a number of steps nationally to identify and correct
shortfalls with the proper set up, use, reprocessing, and maintenance
of reusable endoscopy equipment at all other VAMCs.
The Safety Step-Up Week and the series of communications to the
field (including memoranda, the patient safety alert, and reminders on
national calls and at national meetings) alerted all facilities about
potential problems with endoscope processing and training. Facilities
have been given an opportunity during national calls to inform other
facility leaders about what they have learned concerning the discovery
of problems, patient disclosures, or best practices.
VHA developed, published and implemented a national directive
(Veterans Health Administration Directive 2009-004, dated February 9,
2009, ``Use and Reprocessing of Reusable Medical Equipment (RME) in
Veterans Health Administration Facilities''). Cornerstones of the
directive are:
Assigning responsibilities, especially at the front line
level with Network and Facility Directors, but also with key staff
within each medical facility;
Requiring oversight programs be established, including
unannounced site audits and quality assurance processes;
Requiring through policy that manufacturers' instructions
for the use, reprocessing, and maintenance of RME must be obtained and
followed. These instructions must be used to develop local standard
operating procedures and have them available for use by staff; and
Requiring staff training and assessing staff competency to
ensure manufacturers' instructions are being followed correctly.
VA's national SPD program has developed several training courses to
increase the professionalism and education of field SPD employees. For
example, VHA has developed a 5-day course, which includes a National
SPD Certification Test, for new SPD staff, particularly front-line
technicians. SPD Chiefs, Assistants and Supervisors can take a three-
day seminar, and managers who supervise Chiefs of SPD can take a
different three-day class. A new 3-day class is available for new SPD
Chiefs and Assistant Chiefs. The VHA National Infectious Diseases
Program and Employee Education System have produced one educational
video for reprocessing endoscopes, distributed it to medical facilities
and is completing the production of another video.
Oversight of SPD is accomplished by both internal and external
mechanisms. First, a National SPD Self-Evaluation involves each
facility analyzing its SPD-related activities twice a year. A
facility's performance is judged in part on the results of this
evaluation. Second, the National SPD Quality Management Observational
Assessment Tool (SPD Tool) was conducted in fiscal years (FY) 2007 and
2008 and is being repeated this fiscal year. VA distributed the SPD
Tool to VISNs and facilities in May for completion. The SPD Tool
requires a four-person team at each medical facility to directly
observe staff members reprocessing cytoscopes, colonoscopes,
bronchoscopes, and upper GI endoscopes. Low outliers identified by this
SPD Tool are scheduled for special site visits. One of the
recommendations of the FY 2008 SPD Tool was to establish and fill
Assistant Chief of SPD positions at all Complexity Level 1
facilities.\1\ All Complexity Level 1 and 2 facilities have been
directed to establish these positions, and facilities are working to
establish and fill them. These positions will assist with the oversight
of reprocessing activities that occur both inside and outside of SPD.
Finally, the National SPD Site Review Program also sends a site review
team each year to one-third of VHA facilities. Areas reviewed by the
site review team include the SPD department and areas outside SPD where
medical equipment reprocessing occurs.
---------------------------------------------------------------------------
\1\ There are five levels of Complexity: 1a, 1b, 1c, 2 and 3, in
descending order of complexity. VA determines facility complexity based
upon a formula that considers the patient population, the patient risk,
the level of intensive care unit and complex clinical programs, as well
as education and research indices.
---------------------------------------------------------------------------
future actions
VA has several initiatives underway to improve SPD and ensure it
becomes a high reliability production environment. We are working to
develop and deploy a systems-based approach that will become the
standard for quality management systems for SPD. In addition, a
workgroup continues to investigate ways to standardize the brands and
models of endoscopes used in a particular facility, which will simplify
reprocessing protocols and training needs. The workgroup is also
evaluating leasing options that will provide repair, maintenance and
training services. VA has issued a request for information (RFI) for a
software solution for SOP management that can also be used for
competency verification and document control. VA expects such software
will facilitate automatically transmitting any changes to the
manufacturers' instructions to users and verifying receipt of these
changes. We are also developing a new directive that will align SPD at
each medical center under the facility Chief of Staff. Standardizing
organizational alignment will simplify communication lines from VA
Central Office to the field and vice versa. It will also enhance clear
lines of authority and responsibility for the SPD function.
To better understand any possible connection between newly
discovered chronic blood borne infections and reports of possible
improper reprocessing of endoscopy equipment, VA has assembled a team
of subject matter experts to conduct a detailed epidemiologic
investigation, starting with an extensive review of electronic medical
records. The review encompasses all recent and prior testing for HIV,
Hepatitis B, and Hepatitis C, as well as other relevant laboratory test
results (e.g. liver function tests); medical histories and risk factors
for each of the three viral infections; and details of the actual
procedures. The team will also review the sequence of patients
receiving endoscopic exams, to assess whether a Veteran previously
diagnosed with one of the three viruses preceded a newly-diagnosed
Veteran on a daily examination schedule. It is very important to note
that, even when completed, this study will not be able to demonstrate
causality. However, it will be able to answer the following questions:
Have all positive test results for HIV, Hepatitis B and C
been confirmed? Are there any false positives?
Is there evidence that any Veteran with a positive post-
endoscope test was infected prior to their endoscopic procedure, but
never diagnosed?
Can we identify whether a patient who was previously
diagnosed with HIV or Hepatitis had an endoscope procedure the same day
as a Veteran who is now newly diagnosed with these viruses?
It is expected that the first phase of this investigation will take
several weeks, to permit review of relevant charts and completion of
any additional blood work. We will share the results with the Committee
when it is available. Additional analyses will need to be performed
after the remaining patients exposed have been tested.
Very limited information exists in the medical literature that
could elaborate or quantify the known risks associated with
reprocessing of endoscopy equipment. One long-term review (1970 through
2003) examined health care associated infections related to
gastrointestinal endoscopy and found 281 transmitted infections.\2\
Major reasons for endoscope-related infections from this study were
inadequate cleaning, improper selection of a disinfecting agent,
failure to follow recommended cleaning and disinfection procedures, and
flaws in endoscope design or automated endoscope reprocessors. Failure
to follow established reprocessing guidelines has continued to result
in infections associated with gastrointestinal endoscopes.\3\
---------------------------------------------------------------------------
\2\ Seoane-Vazquez E. et al. (2007). Endoscopy-related infections
and toxic reactions: an international comparison. Endoscopy 39(8): 742-
78.
\3\ See ibid.
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Flexible endoscopes are particularly difficult to disinfect and
easy to damage because of their intricate design and delicate
materials. Meticulous cleaning must precede any sterilization or high
level disinfections of these instruments. Failure to perform thorough
cleaning can result in sterilization or disinfection failure, and
outbreaks of infection can occur.\4\ Because of the large variety of
types and models of endoscopic equipment, a single, standard process
for reprocessing all reusable endoscope equipment does not exist. This
equipment is also constantly being updated, improved, and changed. Our
responsibility for effective maintenance and disinfection is further
complicated by the growing plethora of equipment, as each type of
equipment or each piece and component requires unique reprocessing
techniques. The leasing option described above is one approach to
improving SPD and should help address this concern.
---------------------------------------------------------------------------
\4\ See Seoane-Vazquez E., Rodriguez-Monguio R. (2008). Endoscopy-
related infection: relic of the past?. Curr Opin Infect Dis; 21(4):
362-6.
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A recent article summarized the information available in the
scientific literature about endoscopy-related exogenous infections (an
infection having a cause from outside the body) or pseudo-infections
(where patients may have a positive test result but do not develop
clinical symptoms). The article identified 140 outbreaks during the
period 1974 through 2004, roughly half of which occurred in the United
States and half elsewhere.\5\ Overall, the risk of infection due to
inadequate endoscope reprocessing is reported as very low.\6\
---------------------------------------------------------------------------
\5\ See ibid.
\6\ See nn 2, 4, ibid; also Schembre D.B. (2000) Infectious
Complications Associated with Gastrointestinal Endoscopy.
Gastrointestinal Endoscopy Clinics of North America; 10(2) 215-231.
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conclusion
Quality is a journey without end. Our quality monitoring systems
continue to be refined and, by objective measures of performance,
indicate that VHA continues to set the pace for health care in the
country. Nonetheless, the recent troubling revelations regarding
endoscope reprocessing show just how hard it can be to ensure that care
is safe and effective 100 percent of the time. We do feel, however,
that these revelations validate our effort over the past several years
to develop a culture of transparency in which staff are not afraid to
raise issues and concerns and in which we share with our Veterans and
other stakeholders our success and our shortcomings. This allows us to
re-think and re-design our systems of care and create additional tools
and measures to strengthen quality management.
Mr. Chairman, quality remains a priority at VA. Our Veterans are
the finest America has to offer and they deserve the best care
possible, and because of our quality and safety programs, I can state
VA is answering that call. Thank you again for the opportunity to
testify. My colleagues and I are prepared to answer your questions.
Chairman Akaka. Thank you very much, Dr. Cross, for your
testimony.
Dr. Cross, this morning, we received a copy of the contract
for radiation oncology services at the Philadelphia VA. It
looks like VA paid $133,000 for about 5 months of radiation
oncology services. Yet, nationally, such physicians make an
average of $165,000 for an entire year's work. My question to
you is: Did VA get their money's worth here?
Dr. Cross. Sir, I do not know what the amount was we spent
on that contract. The comparison that you give in regard to
others, I think, is that they were working, I think, only part-
time on some of these programs.
I do not think we got our money's worth, and I would like
to reflect what some external reviewers reported to us. I have
their report, sir, right here that you can request if you
choose to.
They were reviewed. Those individuals you are talking about
were reviewed by the American College of Radiation Oncology. I
will read you just a couple of their comments. This is an
external reviewer looking at the quality of the program at the
exactly relevant time that you are talking about.
And they said, this process utilized to evaluate your
practice consisted of in-depth appraisals of your practice,
your facility, your equipment, policies, procedures, staff and
clinical treatment methods, and they describe their review as
extensive. They reported that the VA radiation oncology
program--this is their statement, not mine--``This VA radiation
oncology department is under the control of the University of
Pennsylvania.''
They went on to say in their report that there is a very
strong quality assurance program for the doctors and technical
staff, both intra and interdepartmental. There is a printed
summary of a chart-check tumor board and peer review which
appears fully accurate and, according to the onsite physician
reviewer, it is ``the best I have seen on any site visit.''
He says, continuing medical education was available to the
physicians and staff, and it appeared that they met or exceeded
the State licensure requirements.
Here is the summary conclusion from this report: ``In
summary, your PVAMC practice, as noted above, is well
organized; an operated radiation oncology practice that not
only meets but in many aspects exceeds the ACRO standards for
practice accreditation. The ACRO is pleased to inform you that
the PVAMC has been awarded full 3-year accreditation.''
Chairman Akaka. Thank you, Dr. Cross, for the answer you
gave me before you read that letter.
Dr. Cross, we have heard many proclamations about how VA
care is the best anywhere. How can VA's care be the best
anywhere in light of the problems we heard about today?
Dr. Cross. Sir, I appreciate your asking that question.
Our best care anywhere I think is true, and it is in regard
to the overall organization.
The problem I am facing, the problem I am working with and
that I am challenged to change is consistency. It is not enough
that we are better. I take no glory in that. I take no pride in
that. That is, as long as any patient is being hurt anywhere
because there is a deficiency or variation, I cannot be
satisfied.
So the issue here is consistency throughout this large
system. I have 1,400 plus sites of care. I have to make sure
that every single one of them is performing up to standard on
these very complicated procedures, and these are complicated
procedures with many, many steps.
We wrote that there are directions from the manufacturer.
Well, it turns out that every single scope has a direction. It
turns out that every different manufacturer has directions. It
turns out that different scopes have different directions. Then
they change them periodically as they upgrade their thinking
about it. Furthermore, other organizations put out guidance,
and they all vary one from the other.
We have said we cannot deal with that. We are a large
organization. We have to have consistency. You must go by the
current directions from the manufacturer. That is the only
standard that we will follow. We will ignore the other ones
because we have to focus on that.
And these slides that we have given you, sir, reflect the
broad overview of VA quality; and even our patients fare better
in terms of mortality within our system than in other systems.
But that is not enough for me. That is not enough for you, I
believe, sir. While there is any problem left, we have to deal
with that variation.
Chairman Akaka. Thank you very much.
Let me call on Senator Burr for his questions.
Senator Burr. Thank you, Mr. Chairman.
Dr. Cross, welcome. And to all that are here, I meant what
I said earlier. I hold you in high esteem for the jobs that you
do.
Oversight, I hope you understand, is a very important role
of this Committee, and I think it is impossible to fully
understand the depth of a problem until you have had an
opportunity to air it. Our role is to take bits and pieces that
are out there and try to construct a picture out of it. It is
not pleasant. I would rather not spend the time on it, but I
think we all agree that the patient population that is served
demands that we do this.
Let me ask you, Dr. Cross, how many hospitals in the system
today are compliant with the VA plan for sterilization from
infection of reprocessing equipment?
Dr. Cross. Sir, like you, I was very disappointed in the
report from the IG on their documentation issue--looking at the
documentation of the SOPs and the training documents had to be
in place. In fact, I mandated that each of the VISN directors
report to me within days that every single one of those SOPs
were in place and that every single one of those training
documents were in place, and that if I walked into one of those
places this morning I could be absolutely assured that I would
find them. They certified that to me in writing about 2 weeks
ago.
Senator Burr. You read an independent review of the
Pennsylvania facility on the brachy treatment. If an
independent facility went and assessed all of the facilities
relative to reprocessing devices, would the report be as
glowing today?
Dr. Cross. You have hit right on the issue. None of those
external agencies found the problem. None of the oversight
organizations, of which we have many, found any of these issues
with endoscopy reprocessing or with the brachytherapy program.
We reported those. We found them internally.
That is why it is so important--this is the critical
point--that we have external oversight and that we have
internal reporting. My staff have to believe that they should
do the right thing. If they see something wrong, they have got
to come report it.
And I have got to be very careful about discouraging that
by saying that I am going to shoot the messenger. I do not want
to do that. If anything, I would like to reward the messenger.
But then I have to balance that with the external
reporting, like with the IG, that we have a very collaborative
relationship with. After they told me that they made the
correction, the IG sent people out to look and make sure that
it was done. If they were not, then that becomes for me an
accountability issue.
And we are now taking disciplinary action at multiple sites
across the country, reluctantly, not so much for the people who
reported the problems--not at all--but for the people that I
held accountable to institute the corrections. And so, those
issues largely related to supervisors. They include demotions.
They include, in some cases, changes of jobs, changes of
organization, and I think one person resigned.
Senator Burr. In the National Center for Patient Safety
review of the situation dated 17 April and included in the IG's
report, the VA stated the following: ``The analog for endoscopy
reliability would be commercial or military aviation
maintenance.''
I am going to be real direct on this one. Keeping in mind
that that is your statement and not mine, if a surprise
inspection was done on an airline and it was found that the
airline was compliant with both procedures and documentation 43
percent of the time, would you fly on it or would you have your
family fly on it?
Dr. Cross. Well, fortunately, documentation and the actual
care of the patient are not necessarily the same thing, but I
feel no satisfaction in that. I was distraught by that report.
I found it unacceptable, and that is why I mandated that my
VISN directors immediately confirm to me that, in fact, the
paperwork that the reviewers were looking for was in place.
I agree with you. I would have been very concerned.
Senator Burr. I requested and received a list of dates when
endoscopy procedures were performed for those veterans who
tested positive. I am not an epidemiologist, I admit that, but
I would gather that if multiple veterans who tested positive
had this procedure performed at the same hospital on the same
day, then there is a fairly good chance that the VA caused at
least one of those infections.
The data I received back from Augusta shows that five of
the seven infected patients had this procedure performed on the
same day as another infected veteran--on April 16, June 10,
August 20, September 10; two infected patients had this ENT
procedure performed on the same day.
What is the VA's opinion of these facts?
Dr. Cross. Here is what we have done. We have asked the
epidemiology team--these are scientists that deal with
investigation in terms of how infection occurs, where it
spreads and so forth--that they look at this and do a detailed
analysis, including genetic testing of the viruses to see if
there is any link at all. They are in the process of doing this
at this time. However, sir, I do have a statement I can read to
you at this moment.
Senator Burr. OK.
Dr. Cross. Coming from my epidemiology team in regard to
the numbers of cases, understanding that this is preliminary,
that they are still working on this, that they do not have a
final report at this time and that we are not ready to draw any
final conclusions at this time. This is just where they are at
the moment.
It should be noted they say that the number of veterans who
have been newly diagnosed with HIV, HBV or HCV as a result or
in association with endoscopy look-back analysis is consistent
with or less than the number of infected veterans that we would
expect to find based on previously published SERO prevalence
studies. Although not definitive proof, this suggests that
these infections are not associated with the endoscopy
procedures.
VA is in the process of conducting an epidemiological look-
back study of those veterans and others who underwent endoscopy
procedures at those sites to better characterize the possible
risk transmission of these infections in these procedures.
That is interesting as a matter of science. But when those
patients come in and we find that they are positive, I am not
worried about what the cause was. I do not question them about
the cause. That is not my issue. I just want to take care of
them at that point--first and foremost, take care of the
patient.
This evaluation that we are doing is all in the background.
It is not to question them. It is not to lay any blame. It is
not to redirect where the responsibility might lie. Our first
priority is to take care of the patient. This is a scientific
investigation that we will publish over time.
Senator Burr. I can go to your charts because you should be
proud of the lack of MRSA infections within the system.
Dr. Cross. MRSA is a scary infection.
Senator Burr. Yes, you highlight it. And there is nobody
today that can tell us we have not done everything to prevent
it. We sterilize equipment. We sterilize operating rooms. Yet,
somehow, this bug lives somewhere.
You highlight the fact that we do a better job than
everybody else. So, I listen to that last response from your
epidemiologist and I ask, well, where does that get us?
I mean I think we all know that there is--I am going to use
Dr. Nolan--there is a structural problem. You cannot assure me
that everybody is doing it exactly like your dictates ask. I
think we all agree with that. We all agree that it should be--
that noncompliance is unacceptable.
I will only say this, I hope that you will publicly or
privately share with us when those epidemiologists come back
after they have looked at the genomic connection, so that we
can know, once and for all, if there was a direct link.
Clearly, when you look at it on the surface, same day, same
place.
Dr. Cross. Different scopes.
Senator Burr. Same process followed within the hospitals.
Dr. Cross. Sir, I concur, and I have already pledged that
when we produce this report it is my intention to publish it.
Senator Burr. My last question, Mr. Chairman. You have been
very kind to me today. Dr. Cross, 297 veterans are currently
being tested for possible exposure to Hepatitis B, C and HIV at
Mountain Home, Tennessee, VA Medical Center. In my capacity as
Ranking Member of the Committee and as a Senator from North
Carolina who represents 7,500 veterans in a 3-county area that
are serviced by Mountain Home, I was not told, my staff was not
told, that you are contacting 297 veterans about the
possibility of infection.
I assume that some of them may be from North Carolina. I
have sort of got two skins in the game: as Ranking Member of
the Committee actively involved in this investigation through
this oversight process; as a Senator from North Carolina
concerned about the veterans that live there, given the fact
that this occurred after the Murfreesboro and Augusta
disclosures.
Why was this not treated at the same level as the other
issues with public disclosure, at least congressional
notification?
Dr. Cross. Sir, let me be very clear that I apologize to
you for lack of notification to your office. The notifications
were done by the local facility to the congressional delegation
in Tennessee. There was also a communication with the
Committee. Also, we put it on the internet to some degree. We
talked to the patients and did disclosure to the patients. In
fact, I have a copy of the internet site here if you want it.
Fortunately, no positives, small-scale and one of the
errors that they made at Mountain Home is a different character
from all the others. The type of antiseptic they were using, it
was not that it was too weak; it was too strong. They were not
diluting it enough, and so the actual concentration of
antiseptic--one of the errors that they were making--was
several times too high.
Senator Burr. Well, let me end with this because my staff
had posed the question and the answer that they got was that it
did not involve a large enough group of veterans.
Dr. Cross. But we did notification, and we did call the
local delegation. We were in error in not notifying you as
well.
Senator Burr. What is the size it has to get to before it
is at a level of importance?
Dr. Cross. Well, at the moment, we are at zero positives.
Senator Burr. No. What is the size of the potential pool
before this raises to the threshold of being concerned?
I mean 297. I am going by VA's statement, and I apologize,
but that is all I can do: ``The decision not to include
Mountain Home results on the national Web site was that it did
not involve a large number of veterans. The local delegation
was notified and veteran disclosure has begun.''
What is the threshold? If 297 does not meet it, then what
is the number?
Dr. Cross. Sir, I will define that according to however you
would like me to define it. If it is one, we will do that.
Senator Burr. I hope that the concern at the VA is one. I
am not sure that an IG investigation, I am not sure that a
public disclosure, and I am not sure that a Web site
notification is required at that number.
But I would just say, as the Ranking Member of the
Committee, I think 297 is a big number. I think that suggests
that there is something extremely serious to look at, whether
there is fire behind the curtain. I am glad to hear that we are
finding out there is not, but I think that that number as a
threshold is significant. I just have a problem with the answer
that we were given, which was it did not meet the threshold of
a large group of veterans.
Dr. Cross. Sir, the only answer I have for you is I
apologize, and it was an error to not inform you.
Senator Burr. I thank you.
I thank the Chair.
Chairman Akaka. Thank you very much, Senator Burr.
Just to let Senator Tester know, we still are in the first
round. Senator Tester.
Senator Tester. Thank you, Mr. Chairman. I will try to make
this as quick as I can.
Dr. Cross, sorry I missed your testimony, but I want to go
back to a previous comment that Dr. Daigh made to get your
opinion on it. He talked about the VISNs' lack of ability to
influence individual hospitals' quality of care. He has taken a
look from a different perspective than somebody inside the
organization. Do you think that this is correct?
Do you think that it can be improved upon and how are you
going to do it? Or, is it not their job? Does it need to come
from somewhere else?
Dr. Cross. Let me say that it is their job, and I think
that has been an area where we need improvement.
Let me tell you how. Let me talk to you for a moment, sir,
if I may, about how this works. I have some of the best experts
in the world on my staff to help me figure how these things
should be done--safety, quality, so forth--and we put out very
good instructions and directives. That is fine. That is a piece
of paper. And then we have meetings and so forth to discuss
that.
Execution then becomes of paramount importance. A key link
in the execution chain is the VISN who are the intermediate
commanders, so to speak. While their focus may be on the
interaction, budget, all of those kinds of administrative
things, quality of care also has to be acknowledged and a part
of their responsibility at all levels. Many of them do a
wonderful job on this. I think that we need to enhance the work
and the role that they play, particularly in quality of care.
Senator Tester. What role does peer review play in quality
of care?
Dr. Cross. Peer review has a long and famous history. It is
not highly regarded in some organizations.
I highly regard it. We track it. We classify the numbers.
We look at each facility in terms of how many peer review
reports, reviews that they are doing and what grade they gave
those reports. If they are not doing very many or if they are
grading them in a way that we think is too generous, we call
them up and talk to them about it.
Senator Tester. How do you guard against retribution from a
negative peer review analysis?
Dr. Cross. In our system, the individual always has the
right to appeal, and they can ask for a further review.
Senator Tester. All right, but I am talking about the other
direction. Let's say that I see something going on as a peer
that is not up to snuff. I report it, and I am dressed down for
it. How do you guard against that?
Dr. Cross. Let me ask my colleagues who might give you
more.
Senator Tester. That would be fine. If you want to defer
it, you can.
Dr. Cross. Juan or Bill?
Mr. Morales. Sure. I am the Director at Tennessee Valley
which is Nashville to Murfreesboro.
Senator Tester. Yes.
Mr. Morales. Part of the peer review process is that if
let's say there is another provider that reports--is that your
question?
Senator Tester. No. My question is that for a peer review
process to work, the person who is being the bad guy--who is
doing the work that nobody wants to do, pointing out an
inadequacy in the system--needs to be guarded against so that
retribution does not take place. How do you stop or guard
against retribution toward somebody who is giving an honest
analysis on somebody who is inept?
Mr. Morales. Well, that is where my responsibility comes
in: to make sure that whatever is being reported by the person,
that we are protecting that person, that we are taking the
right steps.
Senator Tester. Are they being adequately protected now?
Mr. Morales. I can tell you from Tennessee Valley, what we
have in the organization and what we follow, the VHA policy,
yes.
Senator Tester. OK. Yes, go ahead, Dr. Duncan.
Dr. Duncan. I think the key element is building a culture
of quality and safety and building a culture that we are a
learning organization.
Senator Tester. That is right.
Dr. Duncan. I think you can look at peer review as a
punitive mechanism. I think we try to approach it from a
viewpoint that is a learning mechanism. I think that we do
monitor how many of our peer reviews fall into where there are
questions raised about the care, and so we do that, and we do
see that people are utilizing peer review to point out errors
and point out areas we can improve.
Senator Tester. OK. I appreciate those answers. Let's go
back to Dr. Cross.
Dr. Cross, you said that you valued peer review. I know
oftentimes people at the top have certain goals in mind that do
not filter through the system. Maybe VISN is part of it. Maybe
there are other parts. I mean is it valued throughout the
system to the extent you would like to see it valued?
Dr. Cross. Probably not, but here is what I have done to
correct that. I worry about the internal aspects of peer
review, the people who are reporting on their colleagues and
that they may not want to do that.
Senator Tester. Yes, that is right.
Dr. Cross. It is alluding to what you were talking about
before. So I decided we should do this externally as well. So
we now ordered a grant which the acquisition folks are still
working on, nationwide, to give us an external arm of peer
review nationwide, and so that someone completely unrelated
comes in and does this same process and gives us another level
of evidence.
Senator Tester. OK. So you are doing an investigation right
now.
And, excuse me, Mr. Chairman. I know my time has run over.
I have this next question to ask.
You are doing an investigation right now on Hepatitis and
HIV linked to the procedures of the unclean equipment. That is
correct. Who is doing your peer review?
Dr. Cross. On the epidemiology?
Senator Tester. Yes, on your investigation?
Dr. Cross. We are going to publish it in the peer review
journal if they will accept it.
Senator Tester. OK. If there is another round, I will wait.
If not, I can keep going.
Chairman Akaka. We will have another round.
Senator Tester. OK.
Chairman Akaka. Thank you. Thank you, Senator Tester.
Dr. Cross, this is a follow-up to questions that have been
asked on endoscopes. Your testimony that says VA's quality of
care is good and that your quality management works. How, then,
do you reconcile your testimony with the IG's report that only
half--half--of the VA's facilities complied with the internal
policy for endoscopes even after you told them to fully comply
as part of the step-up?
The question is, what is the disconnect? Are your network
directors listening to you?
Dr. Cross. I guarantee you they are going to listen, and
they know how I feel about this report. We had some very heart-
to-heart discussions. I was very disappointed in that report,
and, further, we are holding folks accountable.
Now, again, I want to make the important distinction that
folks who come forward and report things and say they are
wrong, I would like to pat them on the back and say, thank you
for doing a good job.
But when we have identified something is wrong, I expect it
to be corrected; and we have talked about it several times. It
has got to be done, and that becomes an issue of accountability
at that point.
Chairman Akaka. Well, thank you, Dr. Cross.
Last year, we had problems with privileging of physicians
to perform procedures they were not qualified to do at the
Marion VA. Now the person is reporting that the doctor in
Philadelphia responsible for the problems with the prostate
procedures was allowed to do those procedures at VA but not at
the University of Pennsylvania. The bottom line, did the
Philadelphia VA have proof that the physician could perform
this procedure competently before they let him do it?
Dr. Cross. I have not looked into that specific allegation
as of yet.
There is an important distinction here that I would like to
point out to you about something that you raised earlier. You
mentioned the contract and how much it cost. The contract was
not with the individuals. The contract was with the university,
the health care system, to provide the appropriate people to do
that care, but that does not in any way minimize, escape or
excuse our oversight of that process. I want to be very, very
clear. If it is in our facility, it is our responsibility.
And so, sir, I will look into that allegation.
Chairman Akaka. Well, thank you so much for pointing that
out as one would assume the university would send a qualified
person.
Dr. Cross, the IG's reports describe significant problems
in VA's quality management and patient safety efforts, and you
have shared with us what you will do to address those concerns.
But a fundamental question arises. Do you have confidence that
VA's Central Office has a handle on the quality of care being
provided in the field?
Dr. Cross. Senator Burr asked a question a while ago: why
did we change the reporting relationship? I have been looking
for an opportunity to answer that, and this relates to it very
well, as you just opened up that discussion.
Quality is so fundamentally important that the previous
Under Secretary for Health reorganized it. He felt that patient
safety, quality and the Quality Office should not be managed
independently. He found that they should interact very closely;
that they should be working together. They should be within the
same organization. So, he merged those into the same
organization. The head of that organization does report to me,
the Under Secretary of Health, directly.
I would like to have Dr. Duncan comment on that, sir, to
provide further response to your question.
Chairman Akaka. Thank you.
Dr. Duncan?
Dr. Duncan. Thank you for the opportunity to respond.
I cannot speak for Dr. Kussman, but in my conversations
with him, what Dr. Cross said is absolutely correct. The IOM
report, when it was looking at quality health care systems,
defined--and Dr. Nolan gave those to you at his opening
statement--the whole universe of what a health care system
should be. It is that quality includes patient safety and that
our patient safety organization is in Ann Arbor, Michigan.
It is true that they reported directly to the Under
Secretary before. By reporting to me, I am in Washington every
morning. I sit in on the Under Secretary and the senior
leadership of the VA. I sit in with them, and they hear about
quality and safety every day. I am in the Under Secretary's
office. I can walk into his office anytime with any issue. So
it was, I think, Dr. Kussman's desire to elevate the place of
quality and safety, to coordinate it across our whole system.
And the second point I want to make is that quality and
safety does not reside just in my office or in the National
Center for Patient Safety. It is the responsibility of every
program office. It is the responsibility of every facility
director and every member of our VA family to ensure that we
have quality and safety. And so, coordinating that is a huge
job, and this is the reason they set up my office.
Chairman Akaka. Thank you. Thank you very much.
Let me call on Senator Tester for the second round.
Senator Tester. Yes, thank you. Thank you, Mr. Chairman.
OK, Dr. Duncan, quality and safety is your job. I do not
doubt it just by the tone of your voice and your resoluteness
to that.
We are dealing with a number of individuals here. Compared
to the private sector, it may be lower than the standard of
screw ups, but it may be equal to or higher. For the purpose of
this hearing and for the purpose of my perspective, I think I
agree with Senator Burr. One is too many, so we have to go for
zero tolerance.
What are you doing to make sure it gets to the ground, if
you know what I mean? We can have all these visits in Senate
Committees, and we can have visits in Dr. Cross's office and
your office, but the fact is where it happens is in the
hospital, on the ground with the patients. What is being done
to get it there?
Dr. Duncan. I think that is a very central question, and
right now my office is actually right in the center of the
operations. So I have access to the people that oversee the
VISNs and the operational element.
Senator Tester. So, we will just back up for a minute. I do
not mean to cut you off. So what are you doing with the VISNs
since they are inadequate by several different people's
perspective? What are you doing with those VISNs, just for an
example, to get them fired up, get them off their duff and get
them going in the right direction; do what they need to do to
make sure things happen?
Dr. Duncan. We are trying to coordinate. We do this with
many mechanisms where we bring together the various elements in
VHA that are responsible and have quality and safety programs.
We coordinate those at the Under Secretary's Coordinating
Committee for Quality and Safety.
A big player in this is the Operations. The Operations has
the responsibility for doing quality improvement. My office is
doing the coordination. We do the measurement and analysis, and
then we work with them to execute the quality improvement.
They have developed a very robust systems redesign. You
heard Dr. Nolan talking about designing a system. Well, in Dr.
Cross's testimony, you can see the many systems that have been
put in place to do the quality improvement. So this is a
journey that we are on.
Dr. Cross. Can I add just a word to that?
Senator Tester. Yes, you can.
Dr. Cross. A concrete example, in this last go-round when
you heard me say I made them certify that those SOPs and
training documents were in place, I did something else too. By
the 14th of July, their staff are to have visited every single
facility unannounced--unannounced by the 14th of July.
Senator Tester. What are they looking for?
Dr. Cross. The reprocessing, training, and documentation
issues.
Senator Tester. Do you have the results of those visits?
Dr. Cross. By the 14th of July.
Senator Tester. Oh, July, OK. I am a month ahead of myself.
OK. I would love to see what the results of those visits are.
If that is public information, I would love to get it from you.
And the reason is this: I am a farmer, which is fairly
well-known around here. You can grease the tractor until the
cows come home, but if you don't get on it and get some work
done, nothing ever happens.
And so, we need to make sure that the information that I
believe is in your guys' heads--I really believe it. I believe
that you are sincere about it, and I believe that you want to
see it happen. Something is happening--a disconnect here. It is
not getting to the ground where the work is being done.
I do not know how to do it. I have my own ideas, but you
guys are in the business, and I am sure there are better ideas
than I have.
Just a couple more things, Dr. Cross. Has there been any
evaluation or follow-up as far as the prostate issue and how
many were affected; if any have died?
Dr. Cross. When we found the issue in Philadelphia, which
we found, I decided and the Under Secretary at the time decided
that we should do this the way we normally do things. We should
not just assume that the issue was limited to one facility. So
I mandated a review of all the facilities that do those
procedures.
We did find some deficiencies. I have curtailed some
programs.
Senator Tester. What about its impacts on vets?
Dr. Cross. I am not aware of adverse impact. I know about
the case that was reported in the newspaper. But, in terms of,
you said, mortality?
Senator Tester. Yes.
Dr. Cross. I am not aware of any such issue.
Senator Tester. I just want to close real quick, if I
might, Mr. Chairman.
I spend more time on this Committee than any other
committee I have, and I have some really important committees.
I go around the State of Montana. I visit with vets all over
the place. I have 110,000 of them in the State of Montana. They
all, for the most part, speak very, very highly of the VA.
Because of that, I speak very, very highly of the VA because
the service they offer is really the proof in the pudding.
Where I am getting at on this is that I know that there are
allowances made for things not happening and certain people
getting sick because of screw ups. I am very proud of the VA. I
think they do a great job. I am not proud of them on this one,
and I think that it needs to be fixed.
And, if the results come back that the private sector is
worse than the VA, do not even look at that. That is too low of
a bar. That is like me comparing things here to the private
sector. We do not want to do that. We want to set our bar at a
standard because, quite frankly, this is a good outfit, and I
do not like to see it get black eyes. And I will do everything
I can do to help you fix it, but in the end it has to be fixed.
I was just given a timeline of how things have happened
here. I know hindsight is 20-20, but if you look at that
timeline it is totally ridiculous that it came to this point.
This should have been fixed a long time ago. I do not think it
slipped through the cracks. And I know you are not Superman,
but we expect you to be.
Thank you very much.
Chairman Akaka. Thank you very much, Senator Tester.
I have a question for the medical center directors from
Murfreesboro, Miami, and Augusta, and really it comes down to
two questions. One is, because we have been talking about this,
how do you go about creating an environment in which employees
feel comfortable bringing problems to the attention of
leadership? That is one.
And the other is, can you describe for us the extent to
which networks and Central Office provide you with oversight on
your quality management work?
So let me, in that order, call on Mr. Morales first, then
Ms. Berrocal and Ms. Wiley. Mr. Morales?
Mr. Morales. Thank you for the question, Senator Akaka.
The environment or the culture of safety--in that employees
can come forward and report things--it starts in my office
setting the example that when things are reported we listen to
the employees, we follow through, and we fix it. If the
employee feels that they are going to come forward and nothing
is done by the leader of the organization, then they know that
they are wasting their time.
So it starts within my office, making sure that when things
are reported we look into it. We report it immediately to the
people that need to hear it, and we take care. The first
question that we ask is was there any harm to our patients?
That is how the culture in the organization starts.
I think the other thing is how important it is to have our
patient safety officers being part of any discussion that has
to do with patient activity because they bring a very different
perspective. They look at things and can help with making sure
that the environments are safer for our patients. So that is
number 1.
Number 2, the support that we get. I can say from my
perspective, that since I have been a director at Tennessee
Valley--I came in at VISN 9--I have gotten tremendous support
in looking at our quality management issues and how we are
structured. We had our CAP review about a year ago, and they
identified some areas that we needed to improve in our program.
We took action. We work very closely with our network office,
and also we follow through when there are things that come from
either the VISN or from Central Office and things that we need
to look at and that we need to pay attention to.
Chairman Akaka. Thank you very much.
And, Ms. Berrocal?
Ms. Berrocal. Thank you, Senator Akaka.
At our medical center, we believe that the patient safety
issue is the responsibility of everyone in the medical center,
and we encourage a culture that would allow people to come
forward.
Similar to Mr. Morales, what we do is we ensure that when
people bring issues to our attention--whether that be a
Congressman's office or an employee, a patient, whomever--we
are listening and we take steps to ensure that they know we are
taking some kind of an action on it. In that same manner, we
assign administrative investigation boards where we think there
might be issues that require more in-depth analysis, and we
take appropriate action if there is something that is not a
system issue, but negligence on someone's part or a misconduct
issue.
I work very carefully with the whole leadership team to
ensure that our decisions are patient-centered, so that if we
are always focused on the patient, what is proper and correct
for the patient, that that is how we should make our decisions,
and that is how we should always question things.
I also indicate to them that we need to create a culture
where it is not just business as usual, but every single thing
we do is important and critical because we take care of
patients' lives.
I have the patient safety officer reporting directly to me.
And what we are doing now with patient alerts and that kind of
thing is: we have them come every Monday. She comes to us and
reports to the whole leadership team in terms of any patient
alerts and who they went to for response, how we are validating
those responses. We ensure that she then keeps the evidence of
how we validated that, so that I can make sure we are
continuing to create a culture of consciousness about patient
safety.
At the network level, we receive a lot of support. We have
a Joint Commission Readiness Program at the network level.
There is a Patient Safety Program. There is the Quality
Management Office that provides support for us. We have the
VISN Performance Improvement Teams that come by the medical
centers and check to see whether we are doing things properly
or not. We, obviously, have the other external reviews that we
have to respond to in terms of our accountability to the
network and Central Office in terms of the IG CAP and the SOARS
visits, and those kinds of things.
Chairman Akaka. Thank you. Thank you very much.
Now we will hear from Ms. Wiley.
Ms. Wiley. Thank you, sir.
In Augusta, we believe that safety has to be embedded in
everything that we do. It is the underpinning of quality, and
we incorporate that. I walk around, as does my leadership team,
and as we are making rounds on our units, talking to our
providers, we talk about safety.
We also incorporate safety as a part of agenda items for
all of our committees, even at the basic levels of the
organization. We include staff in a lot of our safety reviews,
our RCAs--which are our Root Cause Analysis--of systems issues.
We have staff that are involved in that. I sit in on all those
reviews as they are summarized, so that we can look at safety
and other systems issues that might need improvement.
How the VISN supports us in Georgia: monthly, our VISN
director and other members of his staff, including the quality
management officer, come to our medical center where we walk
around and look. We talk. We meet with staff about all the
pertinent issues that may be involved in our performance
improvement activities.
We have a quarterly meeting that encompasses all of the
quality management and performance improvement activities for
all of the eight medical centers in our VISN, so that we are
not only talking about quality at one site. We are looking at
it systematically in our VISN.
Chairman Akaka. Well, thank you very much for your
responses. We really appreciate your being here.
In closing, we have heard of problems today in VA health
care that are very disturbing. It is not enough that VA
outperforms private hospitals in many ways. The Nation's
veterans deserve more, and the Committee will continue to
insist that VA provide the best care anywhere.
I look forward to working with the new administration, and
in a way it is good to say, ``the new administration'' because
it is like a commencement for a new system and a better system
with better quality. We know some of the problems and look
forward to working with you to correct that in the case where
it needs to be corrected and to improve our system. But the
sense here is that you all are poised to move ahead here with
this administration and try to improve the system to deal with
and service our veterans, which is what this is all about.
So thank you very much. I am looking forward again to
working with you and the new administration to find solutions
to the overarching problem of who is managing VA quality. I
think we need to consistently look at this and continue to try
to improve the system and maybe work up a new design, but we
need to change it.
As I like to say to our old-timers, we cannot continue with
a World War II system. We have to change that system and move
it to these current times. This is what we are all about, and,
together, we can bring these changes about.
So thank you very much.
The hearing is adjourned.
[Whereupon, at approximately 12:27 p.m., the hearing was
adjourned.]