[House Hearing, 115 Congress]
[From the U.S. Government Publishing Office]
REUSABLE MEDICAL EQUIPMENT: CONTINUING TO EXAMINE VHA'S STERILE
PROCESSING PROBLEMS
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON VETERANS' AFFAIRS
U.S. HOUSE OF REPRESENTATIVES
ONE HUNDRED FIFTEENTH CONGRESS
SECOND SESSION
__________
WEDNESDAY, SEPTEMBER 5, 2018
__________
Serial No. 115-74
__________
Printed for the use of the Committee on Veterans' Affairs
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Available via the World Wide Web: http://www.govinfo.gov
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COMMITTEE ON VETERANS' AFFAIRS
DAVID P. ROE, Tennessee, Chairman
GUS M. BILIRAKIS, Florida, Vice- TIM WALZ, Minnesota, Ranking
Chairman Member
MIKE COFFMAN, Colorado MARK TAKANO, California
BILL FLORES, Texas JULIA BROWNLEY, California
AMATA COLEMAN RADEWAGEN, American ANN M. KUSTER, New Hampshire
Samoa BETO O'ROURKE, Texas
MIKE BOST, Illinois KATHLEEN RICE, New York
BRUCE POLIQUIN, Maine J. LUIS CORREA, California
NEAL DUNN, Florida CONOR LAMB, Pennsylvania
JODEY ARRINGTON, Texas ELIZABETH ESTY, Connecticut
CLAY HIGGINS, Louisiana SCOTT PETERS, California
JACK BERGMAN, Michigan
JIM BANKS, Indiana
JENNIFFER GONZALEZ-COLON, Puerto
Rico
BRIAN MAST, Florida
Jon Towers, Staff Director
Ray Kelley, Democratic Staff Director
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
JACK BERGMAN, Michigan, Chairman
MIKE BOST, Illinois ANN MCLANE KUSTER, New Hampshire,
BRUCE POLIQUIN, Maine Ranking Member
NEAL DUNN, Florida KATHLEEN RICE, New York
JODEY ARRINGTON, Texas CONOR LAMB, Pennsylvania
JENNIFER GONZALEZ-COLON, Puerto
Rico
Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public
hearing records of the Committee on Veterans' Affairs are also
published in electronic form. The printed hearing record remains the
official version. Because electronic submissions are used to prepare
both printed and electronic versions of the hearing record, the process
of converting between various electronic formats may introduce
unintentional errors or omissions. Such occurrences are inherent in the
current publication process and should diminish as the process is
further refined.
C O N T E N T S
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Wednesday, September 5, 2018
Page
Reusable Medical Equipment: Continuing To Examine VHA's Sterile
Processing Problems............................................ 1
OPENING STATEMENTS
Honorable Jack Bergman, Chairman................................. 1
Honorable Ann M. Kuster, Ranking Member.......................... 3
WITNESSES
Teresa D. Boyd, D.O., Assistant Deputy Under Secretary for Health
for Clinical Operations, U.S. Department of Veterans Affairs... 5
Prepared Statement........................................... 25
Accompanied by:
Beth Taylor, D.H.A., R.N., N.E.A.-B.C., Deputy Assistant
Deputy Under Secretary for Health for Clinical
Operations, U.S. Department of Veterans Affairs
Sharon Silas, Acting Director, Health Care, U.S. Government
Accountability Office.......................................... 6
Prepared Statement........................................... 27
John Daigh, M.D., Assistant Inspector General for Healthcare
Inspections, Office of Inspector General, U.S. Department of
Veterans Affairs............................................... 8
Prepared Statement........................................... 32
REUSABLE MEDICAL EQUIPMENT: CONTINUING TO EXAMINE VHA'S STERILE
PROCESSING PROBLEMS
----------
Wednesday, September 5, 2018
U.S. House of Representatives,
Committee on Veterans' Affairs,
Subcommittee on Disability Assistance
and Memorial Affairs,
Washington, D.C.
The Subcommittee met, pursuant to notice, at 10:03 a.m., in
Room 334, Cannon House Office Building, Hon. Jack Bergman
[Chairman of the Subcommittee] presiding.
Present: Representatives Bergman, Bost, Poliquin, Roe,
Kuster, Peters, and Lamb.
OPENING STATEMENT OF JACK BERGMAN, CHAIRMAN
Mr. Bergman. Good morning. This hearing will come to order.
I want to welcome everyone today as we discuss problems with
the Veterans Health Administration sterile processing of
reusable medical equipment, or RME.
RME items such as endoscopes, forceps, and other surgical
equipment is meant to be used repeatedly rather than discarded
after a single use and, therefore, must be re-sterilized
between uses to prevent infection. These re-sterilization
practices, which fall largely under the jurisdiction of VA
sterile processing services, or SPS, departments, must be both
meticulous and timely to ensure that procedures occur safely
and on schedule.
Today, you will hear a lot of discussion about inspections
and reports. In simplest terms, VA medical centers are required
to conduct annual self-inspections on their SPS departments and
report the findings to VHA. Additionally, VISNs are required to
conduct annual inspections of SPS departments within their
network and report the findings up to VHA central office.
On top of that, VHA central office must conduct triennial
inspections of each medical center SPS department. If followed,
this oversight procedure would help ensure SPS departments are
operated safely.
Based on issues we uncovered regarding VHA's sterile
processing services, we requested that GAO conduct an audit to
identify any systemic shortcomings. Unfortunately, GAO found
VHA's processes for ensuring the safety and consistent
sterilization of RME to be sorely lacking.
The findings in this report represent a collision of
several issues this Committee has tracked throughout this 115th
Congress. Of course the report describes ongoing issues with
sterile processing and workforce management, two challenges
that the VA routinely battles. But an examination of root
causes reveals another familiar theme: breakdowns in enterprise
governance, particularly at the network and central office
level. These create the opportunity for failures in safety
protocols to go unnoticed or uncorrected.
It is troubling to learn that VISNs were not consistently
conducting annual inspections of their medical centers' SPS
departments, meaning that networks don't know if their medical
centers are training their employees, conducting quality
checks, or otherwise running their sterile processing
departments in an appropriate manner.
But what is equally concerning is the fact that VHA's
central office apparently had no idea that some VISNs were
failing to submit SPS inspection reports to central office,
suggesting that blame goes all the way to the top.
Specifically, GAO's report explains how VHA officials were not
even aware that they had not received all of these inspection
reports until we requested this audit and GAO started asking
questions.
To explain a little further, GAO found that over one-
quarter of the expected 144 reports were never submitted. In
some of these cases, GAO found that networks had conducted
reviews but just never bothered to submit reports to VHA
central office. When one network office was asked why they
failed to turn in reports, they told GAO that they ``see no
value in submitting them''.
To that point, VHA officials admitted that they seldom
share information like SPS trends or best practices with the
field, leaving medical centers and networks unaware of how they
compare to other programs and in what areas there is room for
them to improve. If VHA pays this information little attention
and the field has no access to it, then clearly the established
mechanisms for collecting and disseminating data fail to serve
VA employees or, most importantly, veterans. The current
governance structure is simply not getting the job done.
The Committee has raised this issue several times this
year, including an entire hearing dedicated to VHA governance
in general and the role of VISNs in particular. Central to that
hearing and to this one today is the hospital that became the
poster child for many of these issues, the Washington, D.C.,
Medical Center.
Since the OIG's reports in our May hearing, we found out
last month that the D.C. VA Medical Center performed so poorly
this past quarter that its status has been downgraded from
``high-risk'' to ``critical.'' So VHA'S central office will
become even more hands-on in their attempt to rehabilitate the
hospital. It is also still without a permanent director.
The SPS issues we will discuss today are the tip of an
expansive iceberg of governance issues continuing to prevent VA
medical centers from consistently delivering high-quality
health care in a timely manner. I look forward today to not
only discussing solutions to RME-related issues but also
continuing our conversation regarding the broader root problems
that continue to dog the system as a whole.
With that, I yield to Ranking Member Kuster for any
introductory comments she may have.
OPENING STATEMENT OF ANN M. KUSTER, RANKING MEMBER
Ms. Kuster. Thank you, Chairman Bergman, for holding this
hearing, and thank you to our witnesses on the panel,
particularly GAO and IG, who continue to investigate and study
sterile processing of medical equipment and medical supply
chain concerns. It is important that these vital functions
succeed, because their failure, as we now know from too many
incidents, put patients at risk of harm.
The results of GAO's latest report are troubling. Not only
did GAO find that the VA lacked reasonable assurance its
medical centers were following policies intended to provide
clean, reusable medical equipment but that these recent
findings were similar to those reported in 2011.
Worse, the IG found these same problems at the D.C. VA
Medical Center, as referenced by the chair. And for those of
you familiar with the many problems reported by the
whistleblowers at Manchester, New Hampshire, VA Medical Center,
sterilization and facility maintenance issues contributed to
patient-access and quality-of-care problems there as well.
This continued pattern of lax oversight and accountability
over basic functions of a modern hospital is indicative of a
systemic problem with the VHA, a problem that justifies VHA's
listing as an agency of high risk. The sad reality is that the
VA has been on GAO's high-risk list for years, and yet still
the VA has failed to provide an action plan to improve
operations, nor has VA made significant progress in making
obvious corrections to its poorly heeded internal controls.
GAO's report found 27 percent of inspections of the sterile
processing services at VA medical facilities were not even
reported to the national sterile processing office in VA's
central office or that the central office does not communicate
inspection results to the VISNs or VA medical facilities so
that they could address common deficiencies. Without this data,
VA cannot know which of their facilities are experiencing
problems to prevent incidents like those at the Manchester, New
Hampshire, VA.
GAO found that VA has yet to study its nationwide workforce
shortage within sterile processing services so that it can
determine why some facilities are experiencing major problems
due to understaffing.
GAO found that facility infrastructure problems, especially
in older facilities, were leading to inspection deficiencies,
but it is unknown whether VA has the resources, let alone even
a plan, or if they are working on a plan to address these
issues.
And I hope we will hear from you on that today.
In May, this Committee held a hearing that investigated a
related issue, the failed implementation of the real-time
locating system, RTLS, a failure that contributed to problems
at D.C. and a system intended to help manage and provide
oversight and accountability of sterilization.
I am disappointed to see that VA's written testimony lacks
a progress report on this half-billion-dollar system that is
years overdue. And, again, I hope that you will provide this
Committee with an update.
Underlying all of these findings is a lack of planning,
resources, and especially leadership throughout VHA to use the
information it receives in inspections to correct deficiencies,
identify issues, and, as the chair mentioned, disseminate best
practices so that other medical facilities can take action. VHA
must ensure that there is an adequate workforce to clean and
process increasingly complex reusable medical equipment.
To its credit, GAO found that the VA has the organizational
structure and processes in place to ensure medical equipment is
sterilized and processed accordingly. And we also know that
providers, such as the doctors and nurses and frontline health
care staff who care for our veterans, have often gone above and
beyond to overcome supply-chain failures and that lack of
leadership so that veterans will receive quality care.
The importance of good leadership and the willingness to
reform processes at the facility level is crucial for VA
successes. I am pleased to report that, after new leadership
was installed at the Manchester facility, they acted to resolve
issues around sterile processing.
Recent reviews by the joint commission have identified
their reformed practices and procedures as a, quote/unquote,
best practice that the VA should use nationally. And I would
invite the VA to come up and meet with Mr. Al Montoya and to
review what changes were made. These are the actions the VA
needs, and I hope the VA can take the initiative and
disseminate these practices across the country.
What the VA needs, once again, is good leaders and
sufficient resources to ensure that processes are followed so
that our veterans receive the highest-quality and timely care.
I hope from this hearing we can get a commitment from the VA to
devote resources to staff and facility infrastructure to
address logistics and sterile processing challenges and to
ensure that every VA facility inspection leads to corrective
action to address issues threatening the health and well-being
of our veterans.
Thank you, Mr. Chairman, and I yield back.
Mr. Bergman. Thank you, Ranking Member Kuster.
I now welcome the members of our first and only panel, who
are seated at the witness table. With us today from VA, we have
Dr. Teresa Boyd, Assistant Deputy Under Secretary for Health
for Clinical Operations. She is accompanied by Dr. Beth Taylor,
Deputy Assistant Deputy Under Secretary for Health for Clinical
Operations.
Also on the panel we have Ms. Sharon Silas, Acting Director
of the Health Care Team for the Government Accountability
Office. Finally, from the VA Office of Inspector General, we
have Dr. John Daigh, the Assistant Inspector General for
Healthcare Inspections.
I ask the witnesses to please stand and raise your right
hand.
[Witnesses sworn.]
Mr. Bergman. And let the record reflect that all witnesses
have answered in the affirmative.
Dr. Boyd, you are now recognized for 5 minutes.
STATEMENT OF TERESA D. BOYD
Dr. Boyd. Thank you. Good morning, Chairman Bergman,
Ranking Member Kuster, and Members of the Subcommittee. I
appreciate this opportunity to discuss the Department of
Veterans Affairs sterile processing services programs with
respect to reusable medical equipment, or RME.
I am accompanied today by Dr. Beth Taylor, Deputy Assistant
Deputy Under Secretary for Health for Clinical Operations and a
former chief nurse executive with oversight responsibilities of
SPS at a VA medical center.
VHA operates one of the largest health care delivery
systems in the Nation, serving over 9 million veterans, one of
whom is my stepson, who recently transitioned from Active Duty
Navy.
In providing health care services to veterans, VA medical
centers use RME, which must be reprocessed between uses. Due to
the increasing complexity of design and components,
reprocessing has become much more complicated and time-
consuming. Improper reprocessing creates potential risks, such
as infection, and can adversely affect timely access to care,
such as delayed or canceled surgeries due to the lack of
properly reprocessed RME.
Understanding that a successful SPS program involves many
services at a facility, a group of stakeholders came together
earlier this year to address the top trended challenges
reported in our SPS programs. These challenges were identified
through internal audits at all levels of the organization as
well as via issue briefs, an internal communication that I have
come to embrace and welcome.
We identified four major areas to work on: workforce,
including conversion of the sterile processing occupation to
Title 38 hybrid; streamlining contracting and procurement
processes; improvement of reporting and auditing; and
addressing repairs and coordination of such within our aging
infrastructures.
SPS is dedicated to sustainable corrective actions and is
achieved through improved communication, focused education and
training, as well as commitment to collaborative policy changes
with key stakeholders.
In the GAO draft report issued in June 2018, there were
three recommendations to the Under Secretary for Health, which
are detailed in my written testimony, all of which VHA fully
concurs with. We appreciate the GAO report and found it
validating, as their recommendations correspond with our
aggressive actions undertaken prior to the draft report. We are
strongly committed to developing long-term solutions that
mitigate risk and improve quality and safety of the VA health
care system.
Central to the success of SPS operations in the field is a
solid and strong workforce. It is imperative that we have not
only trained and experienced frontline staff but also solid
leadership in every SPS program. We know all too well the risk
that leadership turnover poses on any program, including the
oversight and management of this very complex and vital one.
And we continue to address the need to not only hire and train
frontline staff but retain them.
SPS programs have significantly improved the efficiency and
safety of health care of our veterans, as well as non-veterans,
as exemplified in recent cases of factory vendor deficits noted
by VA staff and who are now working with industry for universal
changes.
Patient safety and infection control will be improved
because surgical instruments are being reprocessed correctly.
As a physician, as a VA leader, and as the mother of a Navy
veteran who receives his care at the D.C. VA Medical Center, I
am confident in our ability as a learning organization to
become one of high reliability.
To sustain these efforts, we look forward to working with
Congress, the GAO, and OIG as we collaborate to modernize VA.
It is critical that we continue this current momentum and
preserve the gains made thus far. Congressional support is
essential to providing care for veterans and their families and
is greatly appreciated.
Mr. Chairman, this concludes my testimony. My colleague and
I are prepared to answer any questions.
[The prepared statement of Teresa D. Boyd appears in the
Appendix]
Mr. Bergman. Thank you, Dr. Boyd.
Ms. Silas, you are now recognized for 5 minutes.
STATEMENT OF SHARON SILAS
Ms. Silas. Thank you. Chairman Bergman, Ranking Member
Kuster, and Members of the Subcommittee, thank you for the
opportunity to be here today to discuss a recently issued
report on the oversight of VA medical centers' processing of
reusable medical equipment.
The VA has a responsibility to ensure that veterans are
receiving safe and timely access to care. Improper processing
of reusable medical equipment could pose extreme risk to
veterans' health, potentially exposing patients to infection or
leading delays in care if equipment are not readily available
for medical procedures.
VA medical centers use reusable medical equipment for a
variety of procedures. This type of equipment can be used
daily, often multiple times, and range from simple medical
instruments such as surgical scalpels to more complex medical
devices such as camera-bearing endoscopes.
Historically, the Veterans Health Administration has
encountered problems ensuring that medical equipment has been
properly processed. For example, in 2009, the VA notified
nearly 10,000 veterans that they may have been exposed to
various infections due to endoscopes that were improperly
processed at VA medical centers.
Since then, both GAO and the VA OIG have reported numerous
times on these challenges, highlighting the need for better
sterile processing practices and guidance and more effective
training for VA's sterile processing staff.
The Veterans Health Administration has tools to help ensure
medical centers adhere to policies and requirements. For
example, each year, VA's regional offices, or VISNs, use a
standardized inspection checklist to review medical centers'
sterile processing programs. There are also issue briefs
generated when a medical center is involved in a significant
safety incident that affects a group or a cohort of veterans.
We examined the Veterans Health Administration's oversight
of VA medical centers' processing of reusable medical equipment
and found that the VA central office did not have complete
information on the VISN inspections of the medical centers'
sterile processing departments, departments which are
responsible for managing and conducting the processing of
reusable medical equipment.
Specifically, we found that for 144 VISN inspections that
were supposed to have been conducted in fiscal year 2017 the
central office was missing 39 inspection reports. Further, we
learned that, in some instances, some of these inspections were
not conducted at all.
We also found that the central office does not analyze or
share information on inspection results across the VA health
care system due to a lack of resources. As a result, VA is
missing out on an opportunity to share lessons learned and best
practices that could help mitigate potential problems across
the VA health care system. And, in fact, VA medical center
staff we spoke with told us they would like information on
inspection outcomes and trends and findings so they can better
address processing challenges.
Lastly, we identified areas where VA medical centers were
experiencing challenges in processing reusable medical
equipment. For example, sterile processing departments
experienced challenges hiring and retaining qualified staff to
properly manage and handle the processing of reusable medical
equipment. These departments, like many others across VA,
typically experience long timeframes to hire qualified staff.
We also heard that staff typically receive low pay and, once on
board, often have to work overtime and have limited
opportunities for job growth.
Particularly as medical equipment continues to evolve and
become more complex, it is even more important that VA has
enough highly trained staff to process reusable medical
equipment.
Based on our findings, we recommended that VA should ensure
that the annual VISN inspections of VA medical centers' sterile
processing programs are conducted, and the findings reported to
the central office and that the results of these inspections be
shared across the VA health care system to help all programs
improve. Lastly, VA should study sterile processing workforce
needs to ensure medical centers have enough qualified staff to
effectively reprocess medical equipment.
In short, although the Veterans Health Administration has
taken steps in the last few years to improve their oversight of
reusable medical equipment, such as developing new guidance and
policies, we found there are still some areas of improvement
needed to ensure veterans continue to receive safe and timely
access to health care.
This concludes my opening remarks. Thank you.
[The prepared statement of Sharon Silas appears in the
Appendix]
Mr. Bergman. Thank you, Ms. Silas.
Dr. Daigh, you are now recognized for 5 minutes.
TESTIMONY OF JOHN DAIGH, M.D.
Dr. Daigh. Thank you, Chairman Bergman, Ranking Member
Kuster, Chairman Roe, Members of the Committee, it's an honor
to be asked to testify before this Committee today.
I think it's fairly straightforward to understand the
functions of sterile processing, logistics, and human resources
at a VA hospital. The OIG report on critical deficiencies at
the D.C. VA highlights the fact that the risk of clinical error
and, therefore, harm to patients increases when these business
functions do not operate successfully. In addition, the poor
performance by these functions increases the cost of VA health
care.
The OIG reports and the current GAO report identify VA's
organizational structure, in my view, as an impediment to the
efficient operation of these business functions by presenting
confusing lines of authority. The current administrative
alignment of VA, in my view, is outdated. It was created before
the widespread use of email, before the prevalence of large
data systems. And it is, I think, time to consider changes to
the organizational structure of VHA's VISN system.
With respect to SPS controls, VA currently places too much
risk-prevention strategy upon the shoulders of the bedside
clinician to recognize and react to problems when the equipment
they are provided may in some way be defective--that is, at the
point of care.
Having said that, this conversation is mostly about the
risk of harm to veterans. I am not infrequently called and
asked to comment on why a facility closed their operating room
or chose to limit certain procedures, and when I call VHA
leadership, invariably I get a wonderfully responsive,
appropriate answer indicating that there was found some defect
in SPS processing or other defect, and they've taken the exact
correct step in the interest to not harm veterans.
I would be pleased to answer any of your questions. Thank
you.
[The prepared statement of John Daigh appears in the
Appendix]
Mr. Bergman. Thank you, Dr. Daigh.
I now yield to Ranking Member Kuster. Do you want to go
ahead and do your questions first?
Ms. Kuster. I would be happy to.
Mr. Bergman. All right.
Ms. Kuster. Thank you very much. Thank you, Mr. Chairman.
And thank you to our panel for being with us today.
I wanted to focus in, and hopefully our VA witness will
have a plan in place about this, but what is being done to hold
senior leaders at VA medical facilities, VISNs, and VHA
accountable for the management failures within the facilities'
sterile processing services? And is there a plan for
improvement and particularly for sharing best practices?
Dr. Boyd. So the first question, about accountability, this
came up in multiple conversations, as I mentioned earlier, when
a group got together in looking at the world of SPS and the
failures and the weaknesses and gaps that we needed to address.
And you mentioned, I think, earlier as well about VHA
governance and some of the modernization as well.
What we found is that--and there's no excuse for it--there
have not been very codified, clear roles and responsibilities
at all levels of the organization. Coming in new to this role,
as many of us did, and coming from the field, this is an
improvement that must occur. So we are working on those roles
and responsibilities at all levels, so everybody knows what the
expectation is, what they're accountable for.
And this goes all the way down to the chief nurse exec
within a facility, who actually reports and works hand-in-hand
with the medical center director, all the way on up through the
VISN, with a quality management or the chief nurse at a VISN
level, all the way on up to my level as well.
Ms. Kuster. Do you agree that, for example, in Manchester,
New Hampshire, surgeries had to be stopped because there was--
the quote that I read--rust or blood on the surgical
instruments? Does that threaten the quality of care for
veterans and even access to care if surgeries have to be
canceled?
Dr. Boyd. So, twofold. It's important that we, like Dr.
Daigh mentioned, actually welcome staff stopping the line when
they find things like that. Now, that being said, if there is a
trend on that, if it's not a one-off, then we need to, you
know, really look, you know, further and deeper and move it to
the left and say, what happened along the way that we're
getting this?
Ms. Kuster. Well, even if it's a one-off, what's the
process? Is there an investigation when that happens?
And, I mean, I guess what I want to hear from you is some
urgency in tackling this. Because another example, there were
10,000 veterans notified of potential hepatitis infection. I
mean, this seems, to me, urgent in terms of our interest in
caring for our veterans.
Dr. Boyd. So you mentioned the 10,000 back in 2009. There
was a tremendous sense of urgency at that point, and that's
when SPS changed from purely an administrative, non-clinical,
logistics-type function in a program very rapidly into a
clinical--under the clinical nurse exec at the field. And
that's when we realized we needed SOPs, standard operating
procedures, in place, manufacturer instructions and to use
those.
And so there was a huge sense of urgency back in 2009. I
hope--
Ms. Kuster. Do you feel like that's lost now?
Dr. Boyd. I do not feel that that's lost, Ranking Member
Kuster.
What we have in place, though--what we're finding now are,
I would hope, the one-off. And if it's a one-off, it's still a
problem. We need to stop and figure out what happened along the
way. Was there a competency issue? Were the SOPs not in place
for that particular frontline staff member? All along the way,
we need to figure that out.
Because you're absolutely right--
Ms. Kuster. It seems like there's also a lack of staff,
there's a shortage of staff, and that there's a long wait time
to hire staff. Is anything being done to focus on that problem?
I understand they enter as a GSA-5. That probably isn't
drawing the quality of the--
Dr. Boyd. Right.
Ms. Kuster [continued].--staff that you need in these
roles.
Dr. Boyd. You're absolutely correct. And one of the major
changes that has recently occurred is that we finally have
changed the occupation series from a strict Title 5 to a Title
38 hybrid, which gives us pay flexibility. It will also--this
is fairly new, so we finally got that. And so this will change
the grades as well.
Now, that's not everything. You know, we still have the
assistant chief and chiefs with which to deal with. But it does
address our authorities at the front line for these folks.
You're absolutely right.
Ms. Kuster. So my time is up. I yield back.
Mr. Bergman. Thank you.
Chairman Roe, you are recognized for 5 minutes, sir.
Mr. Roe. Thank you, Mr. Chairman.
And I want to say that I find it amazing that we're even
having this meeting today. I mean, it's astonishing to me.
Koch's postulates, which the three of you, I know for sure,
know what that is, is a German theory of disease published by
Dr. Koch in 1890. So we've known what that is. The most basic
function that's performed in a hospital--and I know the three
of you all have been in operating rooms, in patients' rooms--is
to make sure that you have sterile equipment in which to
operate and take care of those patients. That is the most basic
thing we do in a hospital.
And I find it absolutely amazing that we're having this
hearing this morning, that we're even talking about it. Because
I know, when I went in the operating room--I've been there
thousands of times, as a primary surgeon, as an assistant
surgeon, as a medical student, as a resident, and then as a
professor teaching residents how to operate--I never even
thought about was the equipment going to be sterile that I'm
using today. Every day, before I went in the operating room,
somebody from the surgical suite would come in and say, ``Dr.
Roe, you're doing this tomorrow. We have your sutures pulled.
We have all the equipment you need to do your surgery.'' I
don't ever recall a case that was canceled because the
equipment wasn't sterilized properly.
If you're in a for-profit hospital system, as many people
have here, that information got out, that thousands of people
potentially were harmed because of that, that hospital system
probably would cease to exist because of lawsuits.
And, I mean, I still cannot imagine that we don't have
procedures, very basically, about how we train people to
sterilize equipment. I find it amazing.
This is my 10th year here. If I'm fortunate enough and come
back, am I going to continue to see stories in the paper about
we haven't gotten--someone's going to the operating--because, I
mean, your stepson may be going into the operating room. And I
would want to think that that young man would confidently go
there, thinking, ``I'm at a VA hospital and I'll be cared for
properly here and that the equipment is sterilized.'' Can he go
there with that assurance?
That's my question. Can he?
Dr. Boyd. I believe he can. And here is--
Mr. Roe. Well, believing is different than knowing that he
can. I want to know that he can go there and that the surgeons
know that the equipment is sterile and that they can
confidently know that when they take he or she veteran to the
operating room or to wherever, to any procedure room, that that
equipment will be functioning and it will be sterile and that I
don't have to even worry about that.
Dr. Boyd. That's correct.
And what I can say to that is this. When you look at
surgical site infections--because I think that's a surrogate
marker for poor or inadequate operative arenas--the surgical
site infection rate at the D.C. VA is 1.09 percent. The
national rate is 1.41 percent. And the most recent industry
data is 1.9 percent. And this is in the operatories; it's the
surgical site infection rate.
I can also say that because of our culture of safety and
our transparency, which we absolutely stress--
Mr. Roe. Let me back up.
Dr. Boyd. Okay.
Mr. Roe. And we can argue about those things. The question
I have--and, obviously, if you're in a trauma center, your
infection rate is going to be higher than if you're doing all
elective surgeries.
Dr. Boyd. That's true.
Mr. Roe. You've got to compare apples to apples. If you're
doing sterile gallbladder laparoscopic cholecystectomies, that
infection rate ought to be minimal. If you're doing gunshot
wounds and trauma, open fractures, you're going to have a
higher infection rate. So you've got to know what you're
comparing to.
Dr. Boyd. Absolutely, sir, yes.
Back to your question, though, of the operations that we
had on the books that were scheduled and that we actually
performed in the VA in the past year, we had over 424,000
surgeries performed, and our cancellation rate was only 0.8
percent that was attributed to RME issues. And our staff report
very quickly, which is a good thing, that they stop the line if
there is an issue. So 0.8 percent of those cases were canceled
due to RME.
Mr. Roe. Let me ask you very quickly, and I know my time is
about expired, but, basically, Dr. Boyd, what are you doing to
address the key oversight breakdowns in the National Program
Office for Sterile Processing?
And then why were these issues not addressed after the 2011
GAO report and the IG report on the Washington, D.C., VA? And
I'll leave that for later if we have a second round.
I yield back.
Mr. Bergman. Thank you.
Mr. Peters, you're recognized for 5 minutes.
Mr. Peters. Thank you, Mr. Chairman.
And thanks to the witnesses for being here.
I did know that in San Diego that there's been a recent
renovation of the sterile processing services facilities. But
there's this issue that I think GAO, Ms. Silas identified with
respect to personnel. They have found that the SPS technician
position was downgraded by the VA's classification unit. The
local facility can't change the classification of that
position. And then, as I think was mentioned, the hiring
process is 3 to 4 months long. There's long hours, limited pay,
limited promotion.
So what, programmatically, is going to be the VA's response
to this? Are we going to talk about changing the classification
of the position? What would we do to make sure we get the right
people taking care of this important task?
Ms. Taylor. I think there's a couple things in response to
your question. One, that it's going to be one of our top
priorities to address the workforce issues. Because you're
absolutely right; these are key to the success of any well-
staffed, well-run SPS program.
The downgrades occurred with regards to the SPS leadership
roles, the chief and the assistant chief, not to the
technicians.
So we did have published guidance this summer that came out
that transitioned them from a pure Title 5 to a hybrid 38,
which Dr. Boyd mentioned. That we consider as step one.
Step two is moving forward to look at those classifications
of our leadership roles and ensure we have the right
classifications, the right salaries to attract the quality and
the skill sets required to run this very complex service.
Mr. Peters. So, Dr. Taylor, do you disagree with any of the
things that Ms. Silas mentioned about the difficulty in hiring
the right kind of employees? Do you generally agree with that?
Ms. Taylor. I generally agree, yes, sir.
Mr. Peters. So you've talked about one reclassification--I
think that's what you said just now--that you did?
Ms. Taylor. The classification of the SPS service, the
downgrade was focused on the chief and assistant chief.
Mr. Peters. Right.
Ms. Taylor. So that's going to be our priority going
forward, is getting those classified at the level we think is
commensurate to attract and retain the quality and skill set we
need.
Mr. Peters. And have you made any specific conclusions
about what you need to do to address this in terms of the level
of salary or--
Ms. Taylor. Yes. We have a workforce work group, actually,
that has convened, started the work earlier this summer. We're
requesting that they provide a do-out by the end of December of
this calendar year focusing on that exact issue, sir.
Mr. Peters. Okay. So, to me, that seems like a lot of time
for a pretty specific question that's been raised about, you
know, one workplace employee. So I am disappointed to hear it's
December.
But when do you anticipate you're going to make a
recommendation on actually changing the conditions or the
turnaround or the salaries so that we know we get the right
people in these jobs?
Ms. Taylor. You know, I think it's important for me to
share that in the interim we're also looking at the application
of the pay authorities that we currently have and ensuring that
the medical centers who have challenges or are in markets such
as San Diego and greater Los Angeles, et cetera, that they're
using those authorities in a way that they can retain the
staff.
For example, you know, retention bonuses that were just
implemented in greater Los Angeles for the technicians, not the
chief or assistant chief but at the technician level, to make
sure that we could retain those individuals.
So that's really a priority for us, to dialogue with the
human resource officers at the VISN and the local levels
between now and the end of the year to ensure that we're using
the authorities we have most--
Mr. Peters. So you're looking at the employment market VISN
by VISN, so that's why it takes more time. Is that what you're
saying?
Ms. Taylor. That's correct. The employment market in
greater Los Angeles is different than the employment market in
Grand Junction, Colorado, for example.
Mr. Peters. Right. Okay.
And then after you get the report in December, do you have
a sense for how long it will take you to make a recommendation?
It doesn't seem like a very complicated thing to me.
Ms. Taylor. I think we should have recommendations within
the next 6 months.
Mr. Peters. All right. Good. Well, I'll look forward to
seeing you back at the Committee--
Ms. Taylor. Yes, sir.
Mr. Peters [continued].--or if the Chairman wants to
entertain it in writing, whatever, we'd be happy to hear what
you do about this.
Obviously, it's fun to hear Dr. Roe talk about how basic
this is. I think a lot of us lay people who are customers in
hospitals, we worry about infections these days. And, you know,
we know that the kinds of infections that we're susceptible to
in hospitals are particularly pernicious. So I think it's
certainly important for us to get in charge of this, and hope
you take that seriously.
Ms. Taylor. Absolutely.
Mr. Peters. Thank you, Mr. Chairman. I yield back.
Mr. Bergman. Thank you, Mr. Peters.
Mr. Poliquin, you're recognized for 5 minutes.
Mr. Poliquin. Thank you, Mr. Chairman, very much. I
appreciate it.
Ms. Silas, you're involved with the GOA, right? GAO.
Whatever it is. I know what you folks do, generally speaking.
Every 3 years, the VA central here in D.C. is supposed to
make sure that 150 or 160 different VA hospitals around the
country submit a report such that the VA central is comfortable
knowing that the hospitals in the field follow a procedure to
make sure things are sterilized when they operate on our
veterans. Is that right? Yes or no?
Ms. Silas. Well, there are actually a number of oversight
tools that--
Mr. Poliquin. Is VA central due to investigate these folks
every 3 years? Yes or no?
Ms. Silas. The VISN inspections happen annually.
Mr. Poliquin. Well, I was going there next, is that we have
18 VISNs, which are the regional folks, right?
Ms. Silas. Uh-huh.
Mr. Poliquin. Not VA central here in D.C., but the regional
folks. And they're supposed to get annual reports from the
hospitals out there. Is that right?
Ms. Silas. Yes.
Mr. Poliquin. Okay. But, if I understand this correctly, in
2017, 27 percent of the hospitals didn't even submit a report
that they followed these protocols to make sure this equipment
is sterile. Is that correct?
Ms. Silas. It was actually 27 reports had been submitted.
Mr. Poliquin. Okay. A bunch have not been, right?
Ms. Silas. Yes.
Mr. Poliquin. Okay. And then those that were submitted, I
think anywhere from 20 to 40 percent did not adhere to the
procedures that were outlined to keep this equipment sterile.
Is that right?
Ms. Silas. Those were the 27--
Mr. Poliquin. Okay. I just heard--thank you.
I just heard from Ms. Boyd, I think it was, that--and read
somewhere, also, that VA central doesn't have enough resources
to make this happen. Doesn't have enough resources.
Let me remind everybody here that 10 years ago the VA
system had 230,000 employees. They now have 385,000 employees.
And over the last 8 years, the budget's gone from roughly $80
billion or $90 billion to $187 billion per year.
You think you can find someone there to do this right?
How long has this been going--Ms. Boyd, how long has this
been going on? How long have we had a problem with making sure
this equipment is sterile, which is so commonsense, so our
veterans, who gave us our freedom, gave us our country, aren't
impaired? How long has this been going on?
Dr. Boyd. So, if I could just make one just real
clarification here--
Mr. Poliquin. Sure.
Dr. Boyd [continued].--the reports that get rolled up, the
audits and the oversight, the site visits that occur from a
VISN into a facility and then also our triennials, there are
160 some-odd checkpoints on there. And it's everything from
documentation of competencies to--
Mr. Poliquin. Yep.
Dr. Boyd [continued].--the humidity, I mean, all sorts of
things.
Mr. Poliquin. Yep.
Dr. Boyd. So, not clearly that they're just not following--
they're not ending up with safe equipment.
Mr. Poliquin. Yeah, I know. That was one of the things you
folks said, that the clinics are so unique that a standard
protocol doesn't fit every site.
Doctor, do you believe that?
Dr. Daigh. I think the standard protocols would apply to a
piece of equipment across each site.
Mr. Poliquin. Yeah, I would think so too.
Could you answer my question, Ms. Boyd, that I asked a
minute ago? How long has this been going on? How long have you
had a problem with this?
Dr. Boyd. Your question, again, was how long have we had a
problem with maintaining oversight?
Mr. Poliquin. No, making sure that the equipment is sterile
at the hospitals such that our veterans are cared for properly,
which means they've got to follow a procedure, right, that's
dictated from central or from the VISNs, and they clearly
aren't doing that. How long has this been going on, all of it?
Dr. Boyd. Okay. So we still have--
Mr. Poliquin. A year? Two years? Ten years? As long as
you've been there? How long?
Dr. Boyd. We do have opportunities to improve our--
Mr. Poliquin. Who is--forget the question, because you're
not going to answer it?
Who is responsible--who is responsible at--I want the head
person who is responsible at VA central to make sure this
equipment is sterile and folks in the field are following the
protocols? Who is responsible? I want a name. Who is it,
please?
Ms. Taylor. We are, sir.
Mr. Poliquin. You are. Good.
You too?
Dr. Boyd. Uh-huh. Yes, sir.
Mr. Poliquin. Wonderful. How long have you been there, each
of you?
Ms. Taylor. I came in April, sir.
Mr. Poliquin. April of this year?
Ms. Taylor. Yes, sir.
Mr. Poliquin. And how long have you been there, Ms. Boyd?
Dr. Boyd. And I came in May.
Mr. Poliquin. In May. So you're new. So I can't point
fingers at you because you're trying to fix the problem, right?
Dr. Boyd. Yes, sir. And we both came from the field.
Mr. Poliquin. Great. Thank you very much. So I won't lose
my patience with you.
Is this getting better, or are you going to come before us
a year from now and say, ``We have the same problems,'' and
these nice folks over at the GAO and over at Inspector General
are going to say, ``No, they talked about it, they haven't
fixed it''? Are you going to fix this or not?
Dr. Boyd. I would like to answer that. Yes--
Mr. Poliquin. Take your time.
Dr. Boyd [continued].--sir.
Mr. Poliquin. Good. When?
Dr. Boyd. Yes, sir. We will be glad to come back here at
the request of the Chairman at any time and give you an update.
Mr. Poliquin. Thank you.
Dr. Boyd. We have multiple work groups, we have multiple
actions in place, thanks to the oversight that we get from OIG
and GAO. They are our partners.
Mr. Poliquin. Before you came here, Ms. Boyd, who was
responsible for this? Before you and Ms. Taylor came here.
Dr. Boyd. So the person in this role prior was Dr. Lynch.
Mr. Poliquin. Was Dr. Lynch. Is he still at the VA?
Dr. Boyd. No, sir. He is retired.
Mr. Poliquin. He's retired. Anybody else involved? Or just
Dr. Lynch, he was the person?
Dr. Boyd. In the role that I--I took over in that role.
Mr. Poliquin. Did he retire, or was he asked to leave?
Dr. Boyd. Oh, he retired.
Mr. Poliquin. He retired. Okay.
Dr. Boyd. Yes, sir.
Mr. Poliquin. Keep doing what you're doing. We'll help you
every way we can. Thank you very much.
Dr. Boyd. Thank you.
Ms. Taylor. Appreciate that.
Mr. Poliquin. Thank you, Mr. Chairman.
Mr. Bergman. Thank you, Mr. Poliquin.
By the way, we will have a second round. So, you know, for
those--because I think we may have some more questions,
especially given the knowledge base of our panel here.
So, Mr. Lamb, you're recognized for 5 minutes.
Mr. Lamb. Thank you, Mr. Chairman.
Ms. Boyd, Ms. Taylor, I just want to ask about an incident
at the Clarksburg VA in West Virginia involving spotting on
some of the surgical instruments. Are you familiar with that
episode? It happened in the last few years.
Yeah. So, when that happened, some of the veterans who were
affected by it, in terms of their appointments and procedures,
were sent up to the Pittsburgh VA, close to where I live, in my
district, and I believe they were treated there in some cases.
And so I was curious, when that happens--I'm assuming it's
probably happened in other places around the country, where
they notice a problem, they look to nearby VAs to cover the gap
in the meantime--is there a mechanism to make sure that the VA
who's covering, in this case the Pittsburgh VA, gets additional
resources or gets additional tools that they need to cover that
new influx of patients? How is that handled?
Ms. Taylor. That's a great question. I think, typically,
the receiving VA will determine that they have the capacity to
assume that additional workload, those additional patients. And
so they will actually reach out and say, ``We can do this.'' So
they may not receive any additional support, because they have
determined that they have the capacity to take--
Mr. Lamb. So they basically volunteer if they're able to do
it.
Ms. Taylor. Uh-huh.
Mr. Lamb. Okay. Thank you.
Ms. Taylor. Yes, sir.
Mr. Lamb. Ms. Silas, you mentioned in your testimony that
at least part of the problem here was a shortage of employees.
And I think you mentioned something about a lack of overtime
pay for those who were remaining and who were working on some
of these issues. Could you just elaborate on that a little bit
more?
Ms. Silas. Certainly. I did note that there was an issue
with overtime. I didn't speak specifically about the overtime
pay.
Mr. Lamb. Sure.
Ms. Silas. But it was something that we heard consistently
across both our interviews with the VISN officials and at the
facility level, that staff were often asked to work overtime
and that that could potentially result in issues with delays in
processing the reusable medical equipment.
Mr. Lamb. And can you just--what is it exactly that you
heard? Can you explain that to me? Because it sounds like, if
they're asking them to work overtime, someone's working on the
problem. So what's the issue?
Ms. Silas. Yeah, that there was a number of vacancies, and
so then they were asked to work overtime to fill for those
vacancy spots. So there wasn't enough numbers of staff in the
program itself to make sure that the equipment was being
processed.
Mr. Lamb. Okay.
And, Mr. Daigh, I just wanted to ask you to elaborate a
little bit on your comments that you think the VA's
administrative alignment is outdated these days. Can you talk a
little bit about the cause and effect? Like, what's the cause
of the failure to comply with sterile processing procedures
from an administrative standpoint?
Dr. Daigh. So, it seems to me that an operating room's
function is pretty basic to the operation of a hospital. And,
it seems to me, that the staffing of SPS, sterile supplies,
staffing of logistics, the pre-check to make sure you have the
equipment that Dr. Roe spoke of, should all occur every day,
all the time without any interruption.
When we go to the VA hospital in D.C., we found that a
number of services that were business offices were critically
understaffed. Something like--I have to make this up, but,
like, half of the people in SPD were not on the books; a
significant portion of the people in logistics were not on the
books.
So, if you're running a hospital where the only metric you
look at is infection rate, for example, that's a good metric to
look at, but it doesn't speak to the business operation of what
you're really trying to do.
So, the short answer is I think the director of a hospital
ought to take whatever action is needed to make his operating
room or her operating room run efficiently. And, if you need
SPD people, then you hire SPD people. If you need logistics
people, you hire logistics people. And if you can't get it
done, then you go up and talk to the next level of command and
say, ``I need help.'' And if they can't get it done, they come
to you and say, ``I need help.''
So, I think this particular problem, I think that at a
national level, whether they're going to buy software, for
example, or whether they're going to have--the government has
certain standards about, you know, classification of people--I
think that's all a national issue. But the actual--just making,
you know, juice out of oranges every day, that has to work well
at the local level.
So, I have a very hard time understanding why these
problems continue to exist. They do exist.
If you go back to 2009, one of the more interesting
features of the episode that we had where VA's colonoscopy
equipment was not being properly reused or recleaned, the Under
Secretary for Health sent out a directive to everyone in the
field and said, we want you to do this. And, it laid out an
organizational structure and a few things they were supposed to
do. We went out about 6 months later and checked to see if
they'd done that, and people just really hadn't.
One of the problems VA has is that health care is local.
Well, local is great unless you're trying to provide a standard
benefit that the government wants to provide to everyone in the
country. You need people in small places to do what the Under
Secretary of Health says every time. You have to see that.
So, your hospital is wired differently than--and it has a
different organizational chart than the hospital in
Indianapolis, then the hospital in D.C. So, all of these lacks
of standards make it difficult for Central Office to
communicate effectively with the field and get things done.
So, I think it's a system that really needs to be
redesigned and thought through, who should be responsible for
this and that and then given the right authorities and then
allowed to do that.
I find VISNs to be very ineffective every time I look to
see what VISNs might do. Maybe--since I only get called to see
problems--maybe they're doing things I'm not aware of. That's a
possibility. But I don't find them to be, you know, the savior
at the end of the day to solve a problem or prevent something
from happening.
Mr. Lamb. Thank you, sir. We seem to hear that a lot as
well.
Mr. Chairman, thank you.
Mr. Bergman. Thank you.
We heard Dr. Roe talk about what it was like to be the
surgeon handling the instruments. My first career, after 7
years of active duty in the Marine Corps, was in the surgical
instrument business.
So let's talk about the end of the case, when the patient's
already left the room, going out into recovery, and they're
taking all the instrument trays, whether they're going back for
processing to go into an autoclave or they're going to go into
a sterile soak, whatever they happen to be doing, but they're
all going to leave that O.R. They're going to probably go on a
cart, whether it gets on an elevator or down a hallway, into
central supply. ``Central sterile supply'' it used to be called
a long time ago.
The point is, would anybody venture a guess at the table
how many of your medical center directors have ever spent any
time in central supply, gloved up, understanding the difference
between what it means to clean the box lock of a hemostat as
opposed to the canula around an optical head? I mean, would
anybody want to venture a guess, how many of your medical
center directors know the details? Not that they're proficient
in all of them, but they've actually hands-on observed or
whatever it is?
Ms. Taylor. Sir, speaking as a former nurse executive, I
can share that all of the directors that I worked with would
accompany me from time to time, whether it's on environment-of-
care rounds, whether it's just rounding to visit the staff--
Mr. Bergman. Okay, so they know how it works. So there's
nobody sitting up in the corner office not having a clue how it
works. So you're saying you're vouching for all your medical
center directors, that they know how things are supposed to go
on in central supply.
Ms. Taylor. The ones I worked with, yes, sir, they did.
Mr. Bergman. Okay.
So then if you're the captain of that ship, if you will,
you're the director of that medical center, and you know that
to eliminate that infection rate because of the use of a dirty
instrument is going to ensure better outcomes for your VA
patients, why aren't the directors of the medical centers who
have a sterile processing unit within their building confines,
why are they not like, you know, a pit bull on your ankle when
it comes to getting it right?
Ms. Taylor. Well, sir, again, I'll speak to the directors
that I have worked with. And they have been pit bulls, a few of
them.
Mr. Bergman. So then what I hear, the VISN is part of the
problem, not part of the solution. So, if I'm the medical
center director, the VISN is somewhere else in another city, I
know I'm responsible for the outcome of my patients. What's
inhibiting the medical center directors from just taking the
bull by the horns and making sure that those standards are
adhered to and those instruments are clean?
Ms. Taylor. I'd like to make one point of clarification,
because we've mentioned ``dirty instruments in the O.R.'' And I
believe it's important to make the distinction that between
``dirty instruments going to the O.R.'' and ``one step in one
process for one piece of equipment or instrumentation is missed
and therefore we are not compliant with an SOP.''
I think how we are measured is if we're completely
compliant with our standard operating procedures. In a 1A
facility where I worked for the past couple of assignments, we
had anywhere from 200 to 250 standard operating procedures,
each of which may have up to 150 steps. So--
Mr. Bergman. Okay. So have we got too many procedures, I
mean, too many steps, too many compliance steps? Because you've
got someone who actually physically has to handle that
instrument--
Ms. Taylor. Yes, sir.
Mr. Bergman [continued].--whether it be in an instrument
tray or whether it be just a separate instrument as in an
endoscope.
Ms. Taylor. That's right.
Mr. Bergman. So they're the ones that are ultimately hands-
on, they're the eyeballs-on. They have their procedures to
check exactly if that instrument passes muster to go back into
a sterile tray, then to go back into the sterilization process,
then to go back into the O.R.
Ms. Taylor. Correct.
Mr. Bergman. So what's inhibiting that it would--do I hear
you saying we have too many compliance--
Ms. Taylor. No. I was attempting to put the noncompliance
in context. It's simple, as was stated before, but simple
doesn't equate to easy. And when you have--
Mr. Bergman. But is someone training--if I'm the person, if
I'm that new person that you've just hired--
Ms. Taylor. Yes.
Mr. Bergman.--and you're teaching me how to clean that
instrument and you're my supervisor, or you're that third-party
training entity--don't care, because companies who manufacture
those instruments, they provide expertise to come in there and
train the people not only how to use the instrument in the O.R.
but also how to clean the instrument so it's ready to use
again.
So whoever is responsible for the training of that
individual, I mean, are we missing something here?
Ms. Taylor. I don't believe we're missing something.
And to go back to a question that was asked a little bit
earlier about the history, in '09 when the issue was raised
initially or when we really had a lot of discussion about this,
again, I was a nurse executive in the field. We had very few,
if any, standard operating procedures. We had very little
guidance. We did not have--
Mr. Bergman. Hold on.
Ms. Taylor [continued].--many structures.
Mr. Bergman. Hold on.
Ms. Taylor. So we--
Mr. Bergman. Hold on. Just hold on here.
Ms. Taylor. Sure.
Mr. Bergman. VA medical centers aren't the only hospitals
in the world--
Ms. Taylor. Correct.
Mr. Bergman [continued].--okay? And in my district, I have
Dickinson County Memorial Hospital, a county hospital, four
blocks from the VA hospital. They do the same procedures, in a
lot of cases. And they're going to have two separate, you know,
central sterile processing departments.
Are you saying that outside the VA system there's not
enough data, not enough standardization procedures that we can
just take what's working in another hospital somewhere--are we
reinventing the wheel here?
Ms. Taylor. I don't believe we're reinventing the wheel,
sir. But I can say that our national office has actually been
asked to consult with the joint commission as they review
sterile processing services not only within the VA but also in
the private sector, because they do believe that the approach
that we have taken is the most thorough.
Mr. Bergman. Well, you know what? When you have a veteran
who's getting a procedure done today, and if they have to think
that they're assuming risk--again, I'll use Iron Mountain,
Michigan, as the example--that they're assuming unnecessary
risk by going to the Kingsford VA Hospital as opposed to going
to Dickinson County Hospital, that's shameful. It's the wrong
thing. And if that's what we're saying in the VA, we have to do
more paperwork and add more--you know, the VISNs involved and
all that, then we've totally missed the boat here.
So you guys are the messengers. You know that. Every time
we have one of these hearings, you come in here and you take
the spears.
Ms. Taylor. Yes, sir.
Mr. Bergman. And the point is we, and all on this
Committee--it doesn't make any difference which side you sit
on--we want to make sure the veterans don't get infections
because instruments aren't cleaned.
So I will yield back.
Mr. Peters, would you like to ask a second round of
questions?
Mr. Peters. I just have one more question--
Mr. Bergman. Okay.
Mr. Peters [continued].--which is an indirect question. And
it has to do with facility maintenance issues, particularly in
older facilities that lack proper ventilation. I know that this
has been an issue with respect to infections as well.
Do you have the resources at the VA to address the
deficiency when they're identified during the inspection? And
do you know how much is budgeted for VHA to address this
problem?
Dr. Boyd. So, for the first part of that question--and
that's a very good question, because one of the areas that we
found early on this year was that we really needed to match up
what goes on in the engineering portion in our infrastructure,
in our facilities, the facilities management, because their
activities, whether it be regular maintenance or flushing pipes
or changing steam traps or whatever, that affects SPS processes
for that day. And so those two people need to--those two
services need to talk. So, very important, especially within
our infrastructures that are aging.
The second part of your question, I am not aware of that
information--I do not have that information, but it's something
that we could get back to you on. It would be someone else that
I'd have to ask about that budgetary line item.
Mr. Peters. Yeah, that would be very helpful. I appreciate
that.
Ms. Taylor. Absolutely.
Mr. Peters. And I would yield back. Thank you, Mr.
Chairman.
Mr. Bergman. Thank you.
Dr. Roe, you're recognized.
Mr. Roe. Thank you.
Just a couple of questions. One, just to reassure people,
most situations, people going to the operating room at a VA
hospital is perfectly safe. I want people to understand that.
These are the outliers that we're talking about today.
And I think Dr. Daigh hit the nail right on the head when
he was talking about this really is a local issue, it's a local
situation, not to a VISN or to the central office; this is very
basic operation of a hospital. And it is to mean these
procedures are there for a reason. They're to protect people.
And like you said, that doesn't make them simple. These can be
very complex things to do. But they're there for a reason, and
they're there for patient safety.
And so I think the responsibility lies absolutely with each
individual hospital director and the director of the O.R. I
mean, it's not any more complicated than that. Doesn't need to
be up here; we don't need to be hearing about it. It needs to
be taken care of at the local level.
And with that being said, how do you evaluate the
performance of a director who's responsible, for instance, for
the VA Washington Medical Center? I've heard about the VA
Medical Center in Washington, D.C., since I've been here, for
10 years.
Ms. Boyd. So, great question. And, actually, that goes back
to one of my earlier comments. I absolutely agree with Dr.
Daigh. We really need to push rights and responsibilities and
authorities down to the lowest level possible. And, in this
case, it is at the front line. That's where we take care of our
veterans every day.
And really to the meat of your question, this year, we
have, in a validation--a timeline right now, we're looking at:
What would be those four metrics that would be conversation
starters? In other words, it would be a high-level way for us
to get kind of a sniff test that maybe this medical center is
not up to snuff with regards to their SPS working. So we have
four metrics in prototype that we're looking at to validate to
see if in fact it's what we need.
In my office, we will be using that with our network
directors, first of all--not solely--but communicating to them
about their medical centers as well. But then we'd be using
that with each medical center as well. And it will allow us to
become over time a more predictive model, we hope, a more
reliable tool to determine if there are some, you know, early
warnings signs of something going astray.
So this is the administrative SAIL metrics for SPS, and we
look forward to coming back and letting you know how that's
working. But we really do need that model and that conversation
with it.
Mr. Roe. Oh, I think it's pretty simple. I mean, if you've
got a hospital that can't get--with the funding we've put out
there. And as Mr. Peters said, are there needs out there we
need to know about? We need to know about it; we'll provide
those resources. But I think if you don't, you've got to
replace your medical center director. I mean, that's so simple
and basic that it doesn't need to go a VISN or central office.
That person needs to do something else, they need to be in a
different line of work if they can't get that done.
Mr. Chairman, I hope that this is the last we have to hear
about this. I hope this is fixed. And, you know, I have never
had an operation in my life, and I had two major ones done on
me in the last 2 years. And it never dawned on me that I have
to worry about whether the equipment was sterile. That was the
least of my worries. That should be the least of any patient's
worries.
I yield back.
Mr. Bergman. Thank you.
Dr. Boyd, we were told at our May 22nd hearing on VISN
restructuring that VA would complete its VISN reorganization
plan by July 1st. It's now early in September, that would be
the 5th. And GAO's report highlights more shortcomings in VHA's
governance structure.
What is the status of the VA's efforts to reform the VISNs,
and when will we be given the plan?
Dr. Boyd. So we have mentioned VHA governance restructuring
and the discussion about VISNs. With our new Secretary now on
board, I do believe--I know he was briefed just very recently,
in the past few days, about the work to date. And so we are
awaiting his discussion and his feedback, his recommendations
to move forward.
Mr. Bergman. Okay. Can you give me a date when we might,
you know, see this information? I mean, can you provide any
insight into the changes that Secretary Wilkie could
potentially be considering?
Dr. Boyd. I wish I could, but I do not have any knowledge
of that.
Mr. Bergman. Okay. Well, do you get a chance to meet with
Secretary Wilkie?
Dr. Boyd. I have yet to have a one-on-one meeting with him,
sir. I do meet with our executive in charge, Dr. Rich Stone, at
the VHA level.
Mr. Bergman. Well, maybe we could facilitate a one-on-one
for you, because then you can pass along to Secretary Wilkie.
And we've talked about this--the urgency or lack of urgency
within, if you will, the bureaucracy to get to an end game,
which we all agree we have to get to sooner rather than later.
Because if you reduce infections, you increase the quality
of care and the recovery and reduce the overall cost. So it's a
win-win for us to tackle. And the case is us, you, VA. And when
I include the ``us,'' I could potentially be that patient on
your table, and I want to make sure, as Dr. Roe said, I don't
have to think about are the instruments clean.
If you don't assume the mission and take control of it and
take responsibility for it, we're going to be having hearings
like this again. We don't want that. We have identified the
problem. There's no wondering what the problem is. The question
is how and how quickly do we move forward with logical
solutions.
So the ball's in your court. And we need, as in ``we,'' all
of the veterans and all of the families of veterans, need a
response to solving the problem. Okay?
And as Dr. Roe said, a medical center director shouldn't
have to go to the VISN to ask permission, or whatever it is, to
run their own backyard, their own operation.
So, anyway, having said that, I'd like to thank all of you
for your testimony today.
Before I close, I'd like to point out that today was the
first time that Ms. Silas testified before Congress.
Is that true?
Ms. Silas. Yes.
Mr. Bergman. First time. Okay. You look forward to coming
back, right? Okay. But, you know, you did an excellent job of
representing GAO. And I'm sure you will be asked, if not
dragged, to come back here, you know, at some point in the
future.
But, you know, with that, the panel is now excused.
I ask unanimous consent that all Members have 5 legislative
days to revise and extend their remarks and include extraneous
material.
Without objection, so ordered.
Mr. Bergman. I once again would like to thank all of our
witnesses and the audience members for joining us here this
morning.
And the hearing is now adjourned.
[Whereupon, at 11:14 a.m., the Subcommittee was adjourned.]
A P P E N D I X
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Prepared Statement of Dr. Teresa D. Boyd
Good morning Chairman Bergman, Ranking Member Kuster, and Members
of the Subcommittee. I appreciate the opportunity to discuss the
Department of Veterans Affairs (VA) Sterile Processing Services (SPS)
programs in respect to reusable medical equipment (RME). I am
accompanied today by Dr. Beth Taylor, Deputy Assistant Deputy Under
Secretary for Health (USH) for Clinical Operations.
VA's Veterans Health Administration (VHA) operates one of the
largest health care delivery systems in the Nation, serving over 9
million Veterans. In providing health care services to Veterans, VA
medical centers (VAMC) use RME which must be reprocessed between uses.
Reprocessing refers to the cleaning, disinfecting, or sterilization of
RME, such as surgical instruments or endoscopes. Due to the increasing
complexity of device designs and components, reprocessing has become
much more complicated and time consuming. Improper reprocessing creates
potential risks, like infection, and can adversely affect timely access
to care, such as delayed or canceled surgeries due to the lack of
properly reprocessed RME. The SPS programs within each VAMC provide
oversight and manage reprocessing within their respective facility. To
help ensure patient safety, VHA policy establishes requirements VAMCs
must adhere to when reprocessing RME. Further, VHA policy requires
inspections to be completed each year to determine the extent to which
VAMCs are following said requirements and that incidents involving
improperly reprocessed RME are reported.
On June 8, 2018, the U.S. Government Accountability Office (GAO)
provided VA with a draft report entitled ``VA HEALTH CARE: Improved
Oversight Needed for Reusable Medical Equipment.'' In the report, GAO
states that VHA does not have reasonable assurance that VAMCs are
following policies related to reprocessing RME. Further, the report
contends that VHA has not ensured that all VAMC RME inspections have
been conducted because it has incomplete information from the annual
inspections from the Veterans Integrated Service Networks (VISN) which
oversee VAMCs. GAO also found that VAMCs face challenges operating
their SPS programs, notably addressing workforce needs. The report
resulted in three recommendations that VHA agreed to implement to
further strengthen the SPS programs and solidify patient safety
standards.
GAO recommended that the USH ensure all RME inspections are being
conducted and reported as required and that the inspection results VHA
has are complete. VHA fully concurs with this recommendation. The
National Program Office for Sterile Processing (NPOSP) will establish
an oversight process for reviewing and monitoring findings from site
inspections and reporting to VA Central Office leadership. NPOSP's
oversight process will include follow-up and feedback loops with VISNs
on their oversight of facility corrective action plans. The Office of
the Deputy USH for Operations and Management will ensure SPS and RME
issues are reported to a National RME Committee advisory group for risk
assessment and response. The target completion date of July 2019
reflects implementation of the new oversight and governance processes
and time for data collection.
GAO recommended that the USH consistently analyze and share top
common RME inspection findings and possible solutions with VISNs and
VAMCs. VHA fully concurs with this recommendation. NPOSP will analyze
data from site inspections; identify trends or risks; develop possible
solutions in collaboration with VISNs; and provide a written briefing
to the National RME Committee, VISNs, and facilities. NPOSP will
publish the briefing and possible solutions on the NPOSP Web site with
a target completion date of July 2019. Additionally, NPOSP will
communicate the report with the VISN and VAMC leadership through
current educational sessions and national calls.
Lastly, GAO recommended that the USH examine SPS workforce needs
and take action based on this assessment, as appropriate. VHA fully
concurs with this recommendation. The VA Workforce Management and
Consulting (WMC) Office is championing an interdisciplinary work group
with NPOSP, the VA Office of Nursing Service (ONS), and the VA Quality,
Safety, and Value (QSV) High-Reliability Systems and Consultation
Service. The work group has identified actions to address the SPS
workforce needs including: a revised qualification standard that will
encompass a specified assignment for a VISN SPS Program Manager;
implementation of an enhanced market-based approach to pay; and
establishment of an occupational-specific recruitment and development
infrastructure. Additionally, WMC will provide workforce related data,
as available, to assist partners in ONS, NPOSP, and QSV in their
development of a staffing model for the occupation. This will allow
VAMCs and health care systems to appropriately determine resources
needed to more effectively execute mission requirements. This
initiative has a target completion date of December 2018.
The VA Office of Inspector General (OIG) released a report in March
2017 entitled ``Critical Deficiencies at the Washington DC VA Medical
Center.'' The report mentioned a myriad of concerns, including SPS
issues. However, despite these issues, the Washington, DC VAMC has
lower infection rates than that of the overall industry. In fact, the
rolling 12-month surgical site infection (SSI) rate for all surgical
procedures assessed under the VA Surgical Quality Improvement Program
ending March 31, 2018, is 1.41 percent nationally, whereas the SSI rate
for the Washington, DC VAMC for the same time period is 1.09 percent.
Notably, these are both lower than the most recent data on infection
rates industry-wide, which found an SSI rate of 1.9 percent.
OIG made several recommendations and VHA concurred in full and has
since taken action. The Washington, DC VAMC Acting Medical Center
Director, in collaboration with NPOSP, and the VISN 5 Patient Safety
Officer, developed a Quality Assurance process which was implemented on
November 2, 2017, to verify the cleanliness, functionality, and
completeness of instrument sets to ensure that the sets are available
when needed. Any non-conformities are communicated to SPS in real time
as well as data collected and aggregated. The Quality Assurance staff
representative for SPS meets with the Chief of SPS twice weekly to
review Quality Assurance monitors.
Moreover, a new policy regarding the proper reprocessing of loaner
instruments and trays was developed, published, and communicated to
staff through training during staff meetings. The policy was also
reviewed by the facility RME Committee, who is charged with
responsibility for monthly tracking of policy compliance. There is
currently a process for reporting all non-conformities in the RME
Committee meeting; these data are reviewed monthly. Also, SPS will
report to the RME Committee monthly regarding the maintenance of
readily-accessible standard operating procedures for all instruments
and equipment within SPS and its satellite areas in accordance with VHA
policy. Compliance with standard operating procedures completion will
be validated through facility and VISN-led inspections as well as
through the monthly RME Committee.
Lastly, SPS will report to the RME Committee monthly regarding the
status of competencies and proficiencies of the SPS employees. Ongoing
compliance with competencies will be validated by competency audits
incorporated into facility and VISN-led SPS inspections. Staff from the
NPOSP provided on-site training to all SPS staff, including contract
technicians, during the week of December 4, 2017. Since that training,
there are staff trained with appropriate competencies to work in all
areas where RME reprocessing is occurring. Competency validation,
however, is an ongoing process. New staff, as part of their
orientation, will have appropriate training and competency validation
prior to independently performing reprocessing. As new equipment or
instrumentation is acquired and as standard operating procedures are
updated and/or implemented, staff members who use the equipment or
instrumentation will have training with competency validation. The
Washington, DC VAMC remains committed to patient safety and the well-
being of our Veterans.
VHA is strongly committed to developing long-term solutions that
mitigate risks to the timeliness, cost-effectiveness, quality, and
safety of the VA health care system. VHA will use these findings to
continue to make improvements and fulfill our mission of honoring
America's Veterans by providing exceptional health care that improves
their health and well-being.
NPOSP is dedicated to sustainable corrective actions. This is
achieved through communication, education, and training, as well as
commitment to collaborative policy changes with key stakeholders which
include workforce management and consulting, logistics, contracting,
facilities management, risk management, and patient safety.
As evidence of VHA's commitment to sustainable improvements, NPOSP
has implemented several actions to enhance the reporting of findings
and improve communication with the field, VISN, and national
stakeholders to provide support for the success of SPS programs. These
actions include: updating NPOSP-led triennial audit/ action plans every
60 days until all non-conformities identified by the audit have been
completed; follow up on all issue briefs relating to SPS every 30 days
until closed; and maintaining regular calls with SPS-challenged
facilities; and organizing a variety of communication methods and
forums to share trends. NPOSP is also in the process of leading a
national initiative consisting of a point-in-time audit, follow-up
training, and a VISN audit - all occurring in the next 90 days. These
events will assist in establishing reliability of the SPS audit tool
and ensure NPOSP has a complete and accurate data set indicating the
current performance of all SPS facilities. To assist in identifying
facilities at risk, NPOSP is developing a risk assessment tool that
will be available for testing in approximately 90 days.
NPOSP recognizes deficiencies and is aggressively creating cultural
changes in quality improvement processes, as well as strengthening
executive communication with all levels of executive leadership in
order to expedite effective change and accountability.
VA is leveraging long-standing staffing models for primary care,
mental health, and nursing and is developing, evaluating, and refining
additional staffing models for other functional areas. VA will continue
to evolve its clinical staff modeling and workforce planning for other
practice areas such as SPS.
Additionally, VA is establishing a manpower-capacity tracking
system for the entire Department and is committed to deploying a
position management solution for both clinical and non-clinical
requirements. An updated, efficiently-aligned position categorization
structure will enable VA facilities to more precisely define their
clinical and non-clinical staffing requirements. Such a structure will
also enable staffing predictive power on the part of VAMCs and VISNs.
SPS programs have significantly improved the efficiency and safety
of health care of our Veterans. Patient safety and infection control
will be improved because surgical instruments are being reprocessed
correctly. In order to sustain these efforts, we ask Congress for
continued support of VA modernization. It is critical that we continue
to move forward with the current momentum and preserve the gains made
thus far. Your continued support is essential to providing care for
Veterans and their families. Mr. Chairman, this concludes my testimony.
My colleague and I are prepared to answer any questions.
Prepared Statement of Sharon Silas
Improvements in Oversight Needed for Reusable Medical Equipment
Chairman Bergman, Ranking Member Kuster, and Members of the
Subcommittee:
I am pleased to be here today to discuss the use of reusable
medical equipment (RME) in the Department of Veterans Affairs (VA). As
you know, VA's Veterans Health Administration (VHA) operates one of the
largest health care delivery systems in the nation, serving over 9
million enrolled veterans. In providing health care services to
veterans, VA medical centers use RME, such as endoscopes and surgical
instruments, which must be reprocessed-that is, cleaned, disinfected,
or sterilized-between uses. \1\ The proper reprocessing of surgical
instruments and other RME used in medical procedures is critical for
ensuring veterans' access to safe care. Accordingly, VHA policy
establishes requirements VA medical centers must follow when
reprocessing RME to help ensure the safety of veterans who receive care
at its facilities.
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\1\ An endoscope is an instrument used for direct visual inspection
of hollow organs or body cavities.
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Nevertheless, VHA has had ongoing challenges related to properly
reprocessing RME. For example, in 2011 we found that VHA had not
provided sufficient guidance to VA medical center staff operating the
Sterile Processing Services (SPS) programs to ensure that staff were
reprocessing RME correctly, which posed potential safety risks to
veterans. \2\ In 2016, the VHA Office of the Medical Inspector reviewed
and corroborated allegations that the SPS department at one VA medical
center failed to provide surgeons with RME free of bioburden, debris,
or both. \3\ Further, in March 2018, the VA Office of Inspector General
reported on problems at another VA medical center including delayed and
cancelled procedures due to the fact that the necessary RME had not
been properly reprocessed and were therefore unavailable. \4\
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\2\ The VA medical center SPS programs consist of the SPS
department, which has primary responsibility for reprocessing RME, and
other areas such as dental clinics, where certain reprocessing
functions occur. See GAO, VA Health Care: Weaknesses in Policies and
Oversight Governing Medical Supplies and Equipment Pose Risks to
Veterans' Safety, GAO 11 391 (Washington, D.C.: May 3, 2011). We
recommended that VA develop and implement an approach for providing
standardized training for reprocessing all critical and semi-critical
RME to VA medical centers and that VA hold VA medical centers
accountable for implementing device-specific training for all of these
RME. VA concurred with this recommendation, and, in November 2012,
stated that over 1,200 employees had been certified by a professional
organization dedicated to the education and certification of SPS
employees. In addition, in March 2016, VA implemented a policy which
requires, among other things, standardized training for reprocessing
RME and oversight of reprocessing activities.
\3\ Bioburden is a measure of an object's microorganism
contamination. See Department of Veterans Affairs, Department of
Veterans Affairs Cincinnati Veterans Affairs Medical Center Cincinnati,
Ohio, Veterans Integrated Service Network 10, TRIM 2016-D-1082
(Washington, D.C.: May 8, 2016).
\4\ See Department of Veterans Affairs, Office of Inspector
General, Veterans Health Administration, Critical Deficiencies at the
Washington DC VA Medical Center, Report #17-02644-130 (Washington,
D.C.: Mar. 7, 2018).
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My testimony today summarizes the findings from our August 2018
report that analyzed VA's oversight of reusable medical equipment. \5\
Accordingly, this testimony addresses
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\5\ See GAO, VA Health Care: Improved Oversight Needed for Reusable
Medical Equipment, GAO 18 474, (Washington, D.C.: Aug. 3, 2018).
1.VHA's oversight of VA medical centers' adherence to RME policies,
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and
2.challenges VA medical centers face in operating their SPS
programs and efforts VHA has taken to address these challenges.
As part of my testimony, I will highlight the three recommendations
we made to VA to improve its oversight of RME and ensure access to safe
care for veterans. VA concurred with all three of the recommendations
and said it would take actions to implement them.
To conduct the work for our August 2018 report, we reviewed VHA RME
policy as well as other documents such as VHA Directive 1116(2), which
describes RME policy requirements and instructions for how inspections
of VA medical centers' adherence to these requirements should be
conducted. \6\ We also reviewed VHA summary data on inspections of VA
medical centers conducted by their respective Veterans Integrated
Service Networks (VISN) in fiscal year 2017. \7\ We reviewed the full
inspection reports provided by the VISNs for inspections the VISNs had
conducted in fiscal year 2017, but for which VHA did not have a record,
and identified information about nonadherence to RME policy
requirements. In addition, we interviewed VHA officials, officials from
all 18 VISNs, and officials from four VA medical centers selected for
our review. \8\ As part of our review, we assessed VHA's oversight
efforts and its efforts to address any identified RME-related
challenges in the context of federal standards for internal control.
\9\ Further details regarding the scope and methodology of our work are
included in our August 2018 report. The work on which this statement is
based was performed in accordance with generally accepted government
auditing standards.
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\6\ See VHA Directive 1116(2), Sterile Processing Services (SPS)
(Washington, D.C.: Mar. 23, 2016). See Department of Veterans Affairs,
Deputy Undersecretary for Health for Operations and Management (10N),
10N Guide to VHA Issue Briefs (Washington, D.C.: June 26, 2017).
\7\ VISNs are responsible for ensuring adherence to VHA's policies
among the VA medical centers within their region.
\8\ We selected the four VA medical centers to achieve geographic
and medical center complexity variation and the highest and lowest
performance regarding operating room lag time. VHA assigns each VA
medical center to one of five complexity groups based on patient
population served, clinical services offered, education and research
complexity, and administrative complexity. Operating room lag time data
captures the time elapsed from one patient leaving and the next patient
entering the operating room; lag time can be attributed to RME not
being available, among other factors. The four VA medical centers we
selected were located in Chicago, IL; Erie, PA; Fort Meade, SD; and
Little Rock, AR. We were not able to speak with the Chief of SPS at the
Chicago Jesse-Brown VA medical center; as such, some of our reported
results are for three VA medical centers.
\9\ See GAO, Standards for Internal Control in the Federal
Government, GAO 14 704G (Washington, D.C.: September 2014). Internal
control is a process effected by an entity's oversight body,
management, and other personnel that provides reasonable assurance that
the objectives of an entity will be achieved.
VHA's Oversight Does Not Provide Reasonable Assurance That VA Medical
---------------------------------------------------------------------------
Centers Are Following RME Policies
In our August 2018 report, we found that VHA had not ensured that
it has complete information from the annual inspections VISNs conduct.
VISNs are required to conduct annual inspections at each VA medical
center within their VISN and to report their inspection results to VHA.
These inspections are a key oversight tool providing the most current
information on adherence to RME policies VA-wide, as VHA does not
inspect every VA medical center each year. VHA's lack of complete
information from inspection results is inconsistent with standards for
internal control in the federal government regarding monitoring and
information that state management should establish and operate
monitoring activities and use quality information to achieve the
entity's objective. \10\ Without complete information from these
inspections, VHA cannot reasonably ensure that VA medical centers are
following RME policies intended to ensure veterans are receiving safe
care.
---------------------------------------------------------------------------
\10\ See GAO 14 704G.
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For fiscal year 2017, we determined that VHA was missing 39-or more
than one-quarter-of the required VISN inspection reports. \11\ VISN
officials suggested several reasons for the missing reports. For
example, an official from one VISN provided evidence that the VISN had
conducted almost all of its inspections, but told us the VISN did not
submit reports to VHA because it has yet to receive information from
VHA regarding VISN inspection outcomes, common findings across VISNs,
or best practices and therefore the VISN sees no value in submitting
the reports. A VHA official told us the office had not been aware that
it did not have all of the required VISN inspection reports because it
has largely relied on the VISNs to monitor inspections since VHA does
not have sufficient resources to do so itself.
---------------------------------------------------------------------------
\11\ VISNs were able to provide GAO with evidence that they had
conducted 27 of the 39 missing inspections.
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We also found in our report that VHA does not consistently share
information, particularly inspection results, with VISNs and VA medical
centers, and that VISNs and VA medical centers would like more of this
information. Specifically, about two-thirds of the VISN and VA medical
center officials we interviewed told us that sharing information on the
common issues identified by VA medical center inspections as well as
potential solutions developed to address these issues would allow the
VA medical centers to be proactive in strengthening their adherence to
RME policies and ensuring patient safety. For example, one VA medical
center official we interviewed told us that there were problems with
equipment designed to sterilize heat- and moisture- sensitive devices,
and that seeing how other VA medical centers addressed the problem
would be helpful. Further, officials from some VISNs we interviewed
said VHA cited their VA medical centers for issues that had been found
at other facilities and that, had they been aware of the issue
beforehand, they could have corrected or improved their processes for
adhering to RME policies.
When asked about sharing inspection results and other information,
VHA Central Office officials told us the office does not analyze or
share VISN inspections information due to inadequate resources. More
specifically, one VHA official told us that the office does create an
internal report of common issues identified through the third of VA
medical centers it inspects each year, but does not share this report
with VISNs and VA medical centers because the office lacks the
resources needed to prepare reports that are detailed enough to be
correctly understood by the VISN and VA medical center recipients.
According to this official, VHA has occasionally shared information
regarding common inspection issues through newsletters, national calls,
and trainings. However, VHA officials we interviewed at 8 of the 18
VISNs and 1 of the 4 VA medical centers we reviewed said that they
rarely or never received such information. For example, officials from
one VISN told us that they recall just one or two instances where VHA
sent a summary of the top five RME-related issues found during VHA
inspections. Insufficient sharing of information is inconsistent with
standards for internal control in the federal government regarding
communication, which state that management should internally
communicate the necessary quality information to achieve the entity's
objectives. \12\ Until this sharing becomes a regular practice, VHA is
missing an opportunity to help ensure adherence to its RME policies,
which are intended to ensure that veterans receive safe care.
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\12\ See GAO 14 704G.
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Based on our findings, in our August 2018 report we recommended
that VA take steps to ensure that all RME inspections are being
conducted and the results of those inspections are reported to VHA as
required. We also recommended that VA consistently analyze and share
top common RME inspection findings and possible solutions with VISNs
and VA medical centers. VA concurred with these recommendations and
said it would establish an oversight process for reviewing and
monitoring findings from RME inspections and for reporting this
information to VHA leadership. Further, VA noted that VHA will analyze
data from RME inspections and share findings and possible solutions
with VISNs and VA medical centers via a written briefing.
VA Medical Centers Reported Facing Challenges Related to RME Policies
and Workforce Needs, but VHA Has Not Sufficiently Addressed These
Challenges
We also found in our August 2018 report that the top challenges VA
medical centers face in operating their SPS programs were related to
meeting certain RME policy requirements and challenges addressing SPS
workforce needs. Regarding the challenges VA medical centers face in
meeting RME policy requirements, the majority of the 18 VISN and four
selected VA medical center officials interviewed reported experiencing
challenges adhering to two requirements from VHA's 2016 Directive
1116(2).
Climate control monitoring requirement. According to
officials from 16 VISNs and two VA medical centers, meeting the climate
control monitoring requirement related to humidity and airflow in
facility areas where RME is reprocessed and stored is a challenge for
some, if not all, of their VA medical centers, particularly older VA
medical centers that lack proper ventilation systems. \13\
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\13\ Under the climate control monitoring requirement, airflow
needs to be carefully controlled in areas where RME is reprocessed and
stored to minimize movement of air from dirty areas to clean areas
(e.g., areas where used instruments are brought to be reprocessed and
areas where unused instruments are stored before usage). Also, humidity
must be monitored in the areas RME is reprocessed and stored so that
humidity levels do not exceed certain thresholds.
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Reprocessing transportation deadline requirement.
Officials from 16 VISNs and two VA medical centers reported that
meeting the reprocessing transportation deadline was challenging for
their VA medical centers. They said this was particularly challenging
for VA medical centers that must transport their RME to another
facility for cleaning, such as community based outpatient clinics in
rural areas that must transport their RME to their VA medical center's
SPS department. \14\ Under the requirement, used RME must be
transported to the location where it will be reprocessed within 4 hours
of use to prevent bioburden or debris from drying on the instrument and
causing reprocessing challenges.
---------------------------------------------------------------------------
\14\ Under the reprocessing deadline requirement, all used RME must
be transported to the location where it will be reprocessed within 4
hours (or 12 hours for offsite facilities if a specific pre-cleaning
spray is used, per a VHA memorandum issued on June 1, 2016).
In a report we issued in September 2017 examining VA's policy
management practices, we recommended that VHA establish a mechanism
through which program offices could systematically obtain feedback from
VISN and VA medical center officials after the implementation of new
national policies. \15\ The more recent findings of our August 2018
report provide further evidence of the need for VA to address that
recommendation.
---------------------------------------------------------------------------
\15\ VHA agreed with our recommendation; however, as of March 2018
VHA had not implemented it. GAO, VA Health Care: Additional Actions
Could Further Improve Policy Management, GAO 17 748 (Washington, D.C.:
Sept. 22, 2017).
---------------------------------------------------------------------------
Regarding the challenges VA medical centers face in meeting SPS
workforce needs, almost all of the 18 VISN officials and officials from
the three selected VA medical centers we interviewed reported
experiencing challenges related to lengthy hiring timeframes, the need
for consistent overtime practices, and limited pay and opportunities
for professional growth. According to these officials, such challenges
make it difficult for SPS programs to maintain sufficient staffing
levels.
Lengthy hiring timeframes. Officials from 14 VISNs and
three VA medical centers reported that the lengthy hiring process for
SPS staff creates challenges in maintaining a sufficient SPS workforce.
For example, officials from one VISN estimated that it can take 3 to 4
months on average to hire a new SPS staff member.
Need for overtime. Officials from 16 VISNs and two VA
medical centers reported that needing SPS staff to work overtime is a
challenge. Further, officials from one VISN told us that their VA
medical center had used overtime to meet increased workload demands
required to implement VHA's RME policies. One official we interviewed
noted that the overtime has led to dissatisfaction and retention issues
among SPS staff.
Limited pay and opportunities for professional growth.
Officials identified limited pay and lack of opportunities for
professional growth as the biggest SPS workforce challenge. \16\ These
officials stated that the relatively low maximum allowable pay
discourages staff from accepting or staying in SPS positions and the
current pay grade does not create a career path for SPS medical supply
technicians to grow within the SPS department. VHA officials told us
that a proposed increase in the pay grade for SPS staff has been
drafted; however, the officials do not know when or if it will be made
effective. Further, according to VHA officials with knowledge of the
proposed changes, the changes could still be insufficient to recruit
and retain SPS staff with the necessary skills and experience.
---------------------------------------------------------------------------
\16\ In our review, officials from all 18 VISNs and three VA
medical centers reported experiencing challenges with relatively low
pay. Officials from 14 VISNs and 1 VA medical center reported
experiencing challenges with professional growth for SPS staff.
While VHA is aware of these workforce challenges cited by VISN and
VA medical center officials, it has not studied SPS staffing issues at
VA medical centers. VHA officials told us that VHA is considering
studying its SPS workforce. However, the agency has not announced a
plan or a timeframe for doing so. Until the study is conducted and
actions are taken based on the study, as appropriate, VHA will not have
addressed a potential risk to its SPS programs. This is inconsistent
with standards for internal control in the federal government for risk
assessment, which state that management should identify, analyze, and
respond to risks related to achieving defined objectives. \17\ Without
examining SPS workforce needs, and taking action based on this
assessment, as appropriate, VHA lacks reasonable assurance that its
approach to SPS staffing helps ensure veterans' access to care and
safety.
---------------------------------------------------------------------------
\17\ See GAO 14 704G.
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Based on our findings, we recommended in our August 2018 report
that VA assess its SPS workforce needs, and take action based on this
assessment, as appropriate. VA concurred with this recommendation and
said that VHA has an interdisciplinary work group that has identified
actions it can take to address SPS workforce needs.
Chairman Bergman, Ranking Member Kuster, and Members of the
Subcommittee, this concludes my statement. I would be pleased to
respond to any questions that you may have at this time.
GAO Contact and Staff Acknowledgments
For further information about this statement, please contact Sharon
Silas at (202) 512-7114 or [email protected]. Contact points for our
Offices of Congressional Relations and Public Affairs may be found on
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above, key contributors to this statement were Karin Wallestad
(Assistant Director), Teresa Tam (Analyst-in-Charge), Kenisha Cantrell,
Krister Friday, and Michael Zose.
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Washington, DC 20548
Prepared Statement of JOHN D. DAIGH, JR., MD, CPA
Mr. Chairman, Ranking Member Kuster, and members of the
Subcommittee, thank you for the opportunity to discuss the Office of
Inspector General's (OIG's) oversight of VA facilities' Sterile
Processing Services (SPS) and how VA has responded to our
recommendations. High-quality sterile processing of reusable
instruments and equipment is critical to patient safety, yet has
traditionally been difficult for VA to consistently deliver.
BACKGROUND
Over the past decade, the OIG has issued significant findings and
recommendations for corrective action related to sterile processing of
Reusable Medical Equipment (RME). As highlighted in our March 2018
report on Critical Deficiencies at the Washington, DC VA Medical Center
(DC Report), there is still cause for concern regarding the management
of sterile processing operations and VA's ability to ensure consistent
compliance with quality standards across its medical facilities. The DC
Report underscores the ongoing need for VA leaders to respond
aggressively to reports of management failures within individual
facilities' Sterile Processing Services and other hospital business
lines that have a direct impact on patient care. Just as consequential,
VA must take appropriate proactive steps to ensure these processes are
properly carried out by adequately trained professionals whose work and
qualifications are being consistently and carefully monitored.
Ensuring that Sterile Processing Services are functioning properly
is of critical importance. To advance both patient safety and sound
financial management, RME must be reprocessed by individuals with the
required competencies, according to manufacturers' instructions and
related procedures, and then inventoried, secured, and maintained in
clean conditions. Proper sterile processing and storage of RME is
essential to preventing contamination and patient infections, as well
as product deterioration. The OIG has reported instances in which
improper sterile processing has resulted in canceled surgeries and
delays in procedures, inefficiency due to repeat processing of RME, and
increased risk of patient harm.
OIG OVERSIGHT
The OIG has provided oversight of Sterile Processing Services
primarily through two types of inspections or reviews. First, we have
conducted reviews and published individual reports in response to
specific allegations of problems with sterile processing of RME,
usually through complaints received by the OIG Hotline. The second line
of reporting results from our Comprehensive Healthcare Inspections
Program (CHIP) in which OIG staff examine sterile processing as part of
recurring routine inspections of VA medical centers (VAMCs).
As an example of specific allegations, in 2009, OIG reported on the
Veterans Health Administration's (VHA) difficulty reprocessing
endoscopes and concluded that, \1\
---------------------------------------------------------------------------
\1\ Healthcare Inspection Use and Reprocessing of Flexible
Fiberoptic Endoscopes at VA Medical Facilities, June 16, 2009.
``Facilities have not complied with management directives to ensure
compliance with reprocessing of endoscopes, resulting in a risk of
infectious disease to veterans. Reprocessing of endoscopes 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.''
In 2010, we reported on similar issues in Puerto Rico where RME was
not properly sent for reprocessing. \2\ In addition to the RME issues
that involve surgical service, the OIG has reported on instrument
reprocessing issues with dental equipment, which is not directly under
the control of Sterile Processing Services in all facilities. \3\
---------------------------------------------------------------------------
\2\ Healthcare Inspection Patient Safety Issues VA Caribbean
Healthcare System San Juan, Puerto Rico, March 6, 2010.
\3\ Healthcare Inspection Reprocessing of Dental Instruments John
Cochran Division of the St. Louis VA Medical Center St. Louis,
Missouri, March 7, 2011; Oversight Review of Dental Clinic Issues
Dayton VA Medical Center Dayton, Ohio, April 25, 2011; Healthcare
Inspection-Review of Improper Dental Infection Control Practices and
Administrative Action, Tomah VA Medical Center, Tomah, Wisconsin,
September 7, 2017.
---------------------------------------------------------------------------
As for CHIP reviews, previously known as the Combined Assessment
Program (CAP) reviews, the OIG performs recurring inspections of all
VAMCs in which we assess a wide range of hospital functions and
performance areas. In the 2009-2010 CAP cycle, sterile processing was
one of the areas reviewed. In a 2010 roll-up report of data and trends
from completed CAP reviews, the OIG provided recommendations for
system-wide improvements to Sterile Processing Services. The OIG
reported the following:
``We identified six areas that needed improvement. We recommended
that the Under Secretary for Health, in conjunction with Veterans
Integrated Service Network and facility senior managers, ensures that:
(1) standard operating procedures (SOPs) be current, consistent with
manufacturers' instructions, and located within the reprocessing areas;
(2) employees consistently follow SOPs, supervisors monitor compliance,
and annual training and competency assessments be completed and
documented; (3) flash sterilization be used only in emergent
situations, supervisors monitor compliance, and managers assess and
document annual competencies for employees who perform flash
sterilization; (4) appropriate personal protective equipment be donned
before entering and worn in decontamination areas; (5) ventilation
systems be inspected and filters changed quarterly in all reprocessing
areas and that temperature and humidity levels be monitored and
maintained within acceptable ranges in sterile storage areas; and (6)
processes for consistent internal oversight of RME activities be
established to ensure senior management involvement.''
Altogether, the above OIG reports highlighted the need for proper
equipment sterilization throughout each medical center. They also
demonstrated that VA did not employ business practice standards that
were consistently enforced in all areas of the medical centers that use
and reprocess medical equipment.
VA RESPONSE
In VA's response to our findings, there was recognition that beyond
the specific issues we identified, there were important organizational
challenges that needed to be addressed to ensure consistent and proper
reprocessing of surgical equipment. In their response to our 2009
endoscopy report, VA stated, \4\
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\4\ Healthcare Inspection Follow-Up Colonoscope Reprocessing at VA
Medical Facilities, September 17, 2009.
``Additional components that VHA will specifically evaluate and
address include organizational structures and systems in order to
ensure reusable medical equipment is reprocessed according to
manufacturers' instructions with high reliability, and to document
facility compliance with recommended standard operating procedures as
well as with implementation of appropriate responses to alerts and
directives impacting reprocessing. VHA will take several measures to
---------------------------------------------------------------------------
ensure this:
A. VHA will implement systems to ensure that all individuals
engaged in reprocessing reusable medical equipment will have device-
specific competencies documented and demonstrated at a minimum on an
annual basis.
B. VHA will implement measures to ensure that device and procedure
specific standard operating procedures (SOPs) are uniformly available,
are updated as required, and are reviewed at least annually.
C. And ensure that robust quality control is implemented and
appropriately documented in all VHA facilities where reprocessing
occurs.
D. VHA will standardize equipment at the facility level where ever
possible to ensure uniformity in the setup, use and reprocessing of
equipment.
E. VHA will negotiate national contracts to ensure standardization
of equipment and leverage its ability to maximize added value from the
vendors, including support of maintenance, repair and training.''
VA also took the significant step of reorganizing the management of
Sterile Processing Services to fall under nursing staff supervision.
The progress that VA made was seen in the 2016 CAP review cycle,
when the OIG again included a section focused on sterile processing.
The OIG team reviewed facility policies, procedures and guidelines for
(1) reprocessing RME, (2) training and demonstrating competencies for
employees who reprocess RME, and (3) quality control measures for
testing bioburdens in endoscopes. In addition, the review tested
whether the manufacturer's instructions for proper sterile processing,
local SOPs, and quality control measures were in place for the
reprocessing of selected endoscopes at central and peripheral areas
within the VAMC. The majority of medical centers reviewed during the
2016 CAP inspection cycle scored above 90 percent in the sterile
processing section. VA also demonstrated that policies were in place to
review the quality of reprocessing of individual scopes if quality
assurance testing indicated the scope was not reprocessed correctly.
\5\
---------------------------------------------------------------------------
\5\ Data pulled from individual CAP reviews from Fiscal Year 2016
cycle.
---------------------------------------------------------------------------
The results of the 2016 reviews indicate that many facility leaders
were focused on ensuring sterile processing of RME was being correctly
performed and demonstrated marked improvement from previous reviews. In
support of these findings, the OIG is aware of numerous instances at
VAMCs where sterile processing errors were made and the proper
corrective actions were taken or the operating room was closed until
further evaluation of instrument status could be obtained. \6\ Although
shutdowns should clearly be avoided, it is important to be supportive
of facilities that recognize a problem and take proper measures to
ensure patient safety. In recent years, the OIG has engaged in numerous
informal discussions with VA leaders when there have been reports or
evidence of a possible sterilization problem at a medical center. In
these instances, we have found overall that appropriate prompt actions
have been taken by VA to ensure sterile processing errors do not result
in more serious adverse outcomes for patients.
---------------------------------------------------------------------------
\6\ Healthcare Inspection - Delayed Access to Primary Care,
Contaminated Reusable Medical Equipment, and Follow-Up of Registered
Nurse Staffing Concerns, Southern Arizona VA Health Care System,
Tucson, Arizona, September 26, 2017.
---------------------------------------------------------------------------
CRITICAL DEFICIENCIES AT THE WASHINGTON DC VAMC
VA's improvements in sterile processing make the findings in our
report, Critical Deficiencies at the Washington, DC VA Medical Center,
all the more startling. \7\ The OIG detailed multiple and extensive
deficiencies within the Washington, DC VAMC's Sterile Processing
Services that impeded healthcare providers' efforts to deliver quality
patient care, included the following:
---------------------------------------------------------------------------
\7\ Critical Deficiencies at the Washington DC VAMC, March 7, 2018.
Problems in the sterile processing of instruments, such
as discolored or broken instruments reaching clinical areas; incomplete
surgical trays in the operating room; improper tracking and
reprocessing procedures for loaner instruments; missing or expired
sterile processing supplies; failure to follow reprocessing
instructions; and not separating clean and dirty items in satellite
reprocessing areas
An ineffective quality assurance program to ensure that
instruments were cleaned appropriately prior to being returned to a
clinical area
No reliable way for ensuring that instrument sets sent
back to clinical areas were complete and ready for use
Some clean/sterile storerooms did not meet selected
infection prevention criteria and/or selected cleanliness criteria
Multiple problems with competencies for the technicians
responsible for sterilizing instruments and equipment, including
expired or undated competencies, lack of documentation regarding
required training, and competencies not consistently updated to keep
pace with manufacturer's issuance of instructions
DC VAMC personnel often attributed deficiencies in Sterile
Processing Services to chronic understaffing. The OIG confirmed that
Sterile Processing Services had experienced historically high vacancy
rates. A number of factors contributed to these rates, including a
failure to maintain accurate data on the number of authorized positions
throughout the medical center; the Resource Management Committee not
performing its duties in accordance with policy; and HR not completing
hiring actions appropriately.
The OIG also determined that high turnover rates in HR leadership
may have contributed to the failure to resolve staffing issues. VA has
reported progress in hiring, but vacancy rates for Sterile Processing
Services staff are still high at the medical center. During our DC
review, VHA leaders reported that they have experienced difficulties in
recruiting qualified SPS staff nationwide, in part because of a
relatively low salary structure. The fact that many VAMCs continue to
provide high-quality Sterile Processing Services suggests that staffing
issues alone do not necessarily result in deficiencies like those found
at the DC VAMC.
Additionally, it is important to note that the problems identified
in the DC Report were not new. It is clear that information and
documentation outlining some, if not most, of the sterile processing
failings in the medical center reached responsible officials as early
as 2013. That includes the DC VAMC leadership, the Veteran Integrated
Service Network (VISN) 5 leaders, and VHA Central Office. \8\ However,
actions taken by leadership did not effectively remediate the
conditions. Overall, the DC Report highlights the negative impacts
resulting from a lack of leadership attention placed upon key business
practices and logistics.
---------------------------------------------------------------------------
\8\ VISN 5, VA Capitol Health Care Network, has managerial
oversight responsibility over the Washington, DC VAMC.
---------------------------------------------------------------------------
During the DC VAMC review process, we noted some real-time
improvements in the cleanliness of storage rooms. The medical center
had entered into a contract with a commercial cleaning service in June
2017 to supplement the medical center Environmental Management Services
staff. Additionally, as of September 2017, the Acting Human Resources
Director reported to the OIG that 138 of 147 authorized EMS positions
were filled. We have conducted a follow-up review of the DC VAMC and
will be reporting our findings in the near future.
CONCLUSION
Although the findings and recommendations in the DC Report focus on
issues in sterile processing at that facility, VHA leadership at all
levels could use the findings as a checklist to ensure properly
functioning Sterile Processing Services at all VAMCs. The DC Report is
about the breakdown of systems and leadership at multiple levels that
other VAMCs should be cautioned to avoid or quickly redress.
The OIG's ongoing oversight and communication with VA leaders
indicates that some individual facilities have made important strides
in how sterile processing is managed. Yet reports like the one on the
DC VAMC makes clear that these problems still resurface in individual
facilities, due in part to both the complexity of the processes and the
lack of adequate internal controls to provide assurance that sterile
processing is meeting essential quality standards. Staffing may also be
an ongoing challenge in addressing sterile processing problems.
Finally, VA must have effective leaders who understand the critical
importance of close oversight of nonclinical services that affect
patient care within medical centers to continue its improvement
efforts. Leaders at all VA facilities must take appropriate proactive
steps and have reactive measures in place to address sterile processing
concerns. Failure to do so puts at risk the safety and quality of care
delivered to veterans.
Mr. Chairman, this concludes my statement. I would be happy to
answer any questions you or other members of the Subcommittee may have.
[all]