[House Hearing, 115 Congress]
[From the U.S. Government Publishing Office]
ASSESSING VA'S RISKS FOR DRUG DIVERSION
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HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON VETERANS' AFFAIRS
U.S. HOUSE OF REPRESENTATIVES
ONE HUNDRED FIFTEENTH CONGRESS
FIRST SESSION
__________
MONDAY, FEBRUARY 27, 2017
__________
Serial No. 115-4
__________
Printed for the use of the Committee on Veterans' Affairs
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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
BRAD R. WENSTRUP, Ohio 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 KILILI SABLAN, Northern Mariana
JODEY ARRINGTON, Texas Islands
JOHN RUTHERFORD, Florida ELIZABETH ESTY, Connecticut
CLAY HIGGINS, Louisiana SCOTT PETERS, California
JACK BERGMAN, Michigan
JIM BANKS, Indiana
JENNIFFER GONZALEZ-COLON, Puerto
Rico
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 SCOTT PETERS, California
JENNIFER GONZALEZ-COLON, Puerto KILILI SABLAN, Northern Mariana
Rico Islands
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
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C O N T E N T S
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Monday, February 27 2017
Page
Assessing VA's Risks For Drug Diversion.......................... 1
OPENING STATEMENTS
Honorable Jack Bergman, Chairman................................. 1
Honorable Ann Kuster, Ranking Member............................. 2
WITNESSES
Carolyn Clancy, M.D., Deputy Under Secretary For Health For
Organizational Excellence, Veterans Health Administration,
Department Of Veterans Affairs................................. 4
Prepared Statement........................................... 26
Accompanied by:
Michael A. Valentino, R.Ph., MHSA, Chief Consultant, Pharmacy
Benefits Management Services, Veterans Health
Administration, Department of Veterans Affairs
Mr. Nick Dahl, Deputy Assistant Inspector General for Audits and
Evaluations,VA Office of Inspector General..................... 6
Prepared Statement........................................... 30
Accompanied by:
Emorfia Valkanos, R.Ph., Health Systems Specialist, Office of
Healthcare Inspections, VA Office of Inspector General
Mr. Randall B. Williamson, Director, Healthcare Team, U.S.
Government Accountability Office............................... 8
Prepared Statement........................................... 33
Keith Berge, M.D., Consultant in Anesthesiology, Chair, Mayo
Clinic Enterprise-wide Medication, Diversion Prevention
Committee, Mayo Clinic......................................... 9
Prepared Statement........................................... 38
STATEMENTS FOR THE RECORD
Jeffrey Plagenhoef, M.D., President, American Society of
Anesthesiologists.............................................. 39
Letter From: Michael J. Missal - Reponse to Question............. 41
ASSESSING VA'S RISKS FOR DRUG DIVERSION
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Monday, February 27, 2017
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 3:30 p.m., in
Room 334, Cannon House Office Building, Hon. Jack Bergman
[Chairman of the Subcommittee] presiding.
Present: Representatives Bergman, Bost, Poliquin, Dunn,
Arrington, and Kuster.
Also Present: Representatives Roe and Walz.
OPENING STATEMENT OF JACK BERGMAN, CHAIRMAN
Mr. Bergman. Good afternoon. This hearing will come to
order. I want to welcome everyone who has joined us today.
Today, we will address the lack of oversight and internal
controls regarding controlled substances within the Veterans
Health Administration that leave facilities open to drug
diversion and veteran harm.
The diversion of drugs from VA health care facilities is an
incredible patient safety issue that puts veterans, VA
employees, and the public at tremendous risk. Unfortunately,
the news has recently been filled with story after story of
drug diversions within VA.
In Little Rock, Arkansas, a VA pharmacy technician
reportedly used his access to medical supplies Web sites to
order and divert 4,000 oxycodone pills, over 3,000 hydrocodone
pills, and more than 14,000 Viagra and Cialis pills, at the
cost to the VA of more than $70,000. This technician was
allegedly selling these drugs on the street, where they had a
value of more than $160,000.
At a VA facility in Florida, a registered nurse was
apparently stealing oxycodone and hydromorphone from the
hospital to feed her addiction. Keep in mind, these are
medications that should have been going to veterans for their
care.
These issues are, in part, a result of VA having inadequate
procedures in place to safeguard against theft and diversion of
controlled substances. A recent Government Accountability
Office audit requested by this Committee found that one VA
medical center missed 43 percent of the required monthly
inspections, mostly in critical care areas such as the
operating room and the intensive care unit. In addition, three
other facilities did not follow all of VHA's requirements for
inspections of controlled substances.
This is not the first instance where weaknesses were
identified in VA's controlled substance inspection program. In
2009 and 2014, the VA Office of Inspector General found that
some medical facilities were not conducting monthly inspections
and some inspections were incomplete. VA has been given
multiple opportunities to address these concerns. This leaves
me wondering what VA is doing to repair the lax oversight and
apparent absence of accountability regarding these issues
within VHA.
To make matters worse, there are also issues with drug
testing employees to ensure that they are suitable to provide
care to our veterans. A 2015 Office of Inspector General report
found that VA Medical Centers were not conducting preemployment
and random drug tests for testing-designated positions in many
instances across VHA, which amounted to tens of thousands of
employees not receiving drug tests required by the Drug-Free
Workplace Program.
Most recently, in January 2017, the OIG found high backlogs
in background checks, to include drug testing, for high-risk
positions at the Atlanta VA Medical Center.
It is precisely these tools that have been put into place
to help protect patients and health care organizations from
drug diversions and harm. However, VA does not seem to be
taking them as seriously as it should.
Based on the oversight reports and numerous diversion
incidents we will discuss today, I am concerned that VA's
controlled substance oversight program is not working and that
staff who fail to follow proper procedures are not being held
accountable for violations.
In case after case, what we see are examples of drugs being
diverted for personal use or personal gain, yet there does not
seem to be much progress made by the VA to correct the glaring
problems that allow it to happen.
What is even more concerning is that the programs to help
deter diversion or identify illegal employee drug use are not
being implemented consistently within the VA health system. We
are in the midst of an opioid epidemic, and it's time for VA to
start making effective changes to avoid putting veterans and
the employees who serve them at risk.
With that, I recognize Ranking Member Kuster for her
opening statement.
OPENING STATEMENT OF ANN KUSTER, RANKING MEMBER
Ms. Kuster. Thank you, Mr. Chairman.
And thank you for choosing this topic. I am particularly
interested, as the cochair, the founding cochair, of our
congressional Task Force to Combat the Heroin Epidemic. I
appreciate this testimony.
This afternoon, we are again examining VA's role in
ensuring that prescription drugs are safely controlled in VA
medical facilities.
Less than a year ago, former Chairman Kaufman and I held a
hearing of the O&I Subcommittee on this very issue in Colorado
because the Drug Enforcement Agency, DEA, found several
violations in the Denver VAMC. We continue to hear disturbing
reports in hospitals and clinics, in our communities, that some
health care employees are stealing controlled substances for
their own personal use or personal gain. We know that these
cases are on the rise throughout the country.
One health care employee diverting controlled substances
can be a serious public health risk and can cause significant
harm to many patients. We learned this lesson the hard way in
New Hampshire with the technician who was injecting himself
with fentanyl at a hospital in Exeter, New Hampshire. But it
turned out this had started at the Baltimore VA Medical Center
and continued in more than a dozen hospitals in other States,
infecting up to 50 patients in our community with Hepatitis C,
and some of these patients were veterans.
From this example, it is clear that the nationwide trend of
opiate diversion also impacts our VA. The VA health system is
one of the Nation's leading prescribers of opioid medication.
Diversion in the VA threatens the safety of veterans and
hampers efforts to address the opioid epidemic in our
communities. Preventing diversion of these substances should be
a paramount concern.
That's why I find the GAO and IG's findings particularly
troublesome. It's unacceptable that some VA medical facilities
are not conducting routine inspections to prevent and identify
drug diversion. Background investigations that could
potentially identify employees who have diverted drugs or who
may have a drug/substance-use problem were backlogged in
Atlanta. Healthcare employees at the Atlanta Medical Center
were not subject to drug testing for 6 months, which could
identify diversion of prescription drugs.
We need to get to the bottom of why these safeguards and
processes are not being followed. I want to know if the
procedures when followed would work to prevent drug diversion.
I want to know if VA has the resources it needs to conduct the
inspections, the background checks, and to administer its Drug-
Free Workplace Program.
I am also concerned about the VA hiring freeze that is
currently in place and that VA HR employees are not exempt. The
GAO and IG identified that staff need more personnel and more
training to properly conduct these inspections. They also
identified the need for more HR personnel to address the
background-check backlog in Atlanta. Without adequate support
staff in place, VA medical facilities will continue to struggle
to comply with the procedures and programs that they must
follow to ensure that our veterans receive safe care.
Finally, I look forward to learning about progress at the
VA with regard to the Opioid Safety Initiative that we passed
within CARA, the Comprehensive Addiction and Recovery program,
just last year to bring down the rate of opioid prescriptions
for all of our veterans. We must do everything we can to help
veterans suffering from chronic pain and to help veterans
struggling with substance abuse and addiction.
The opioid epidemic is destroying the lives of veterans and
their families in communities across New Hampshire and all
across the country, and we need to work together to find
innovative solutions to end this epidemic. As I say to my
colleagues, heroin does not choose R's and D's. We can work
together. We are proud champions of the Comprehensive Addiction
Recovery Act that we passed last Congress, and I look forward
to hearing about VA compliance.
Thank you, Chairman Bergman, and I yield back.
Mr. Bergman. Thank you, Ranking Member Kuster.
I ask that all Members waive their opening remarks, as per
this Committee's custom.
With that, I welcome our first and only panel, who is now
seated at the witness table.
On the panel, we have Dr. Carolyn Clancy, Deputy Under
Secretary for Health for Organizational Excellence. She is
accompanied by Dr. Michael Valentino, Chief Consultant for the
Pharmacy Benefits Management Services of the Veterans Health
Administration.
We also have Mr. Nick Dahl, Deputy Assistant Inspector
General for Audits and Evaluations. He is accompanied by Ms.
Emorfia Valkanos, Health Systems Specialist for the Office of
Healthcare Inspections in the Office of the Inspector General.
Finally, we have Mr. Randall Williamson, the Director of
the Healthcare Team for the Government Accountability Office;
and Dr. Keith Berge, Consultant in Anesthesiology and Chairman
of the Mayo Clinic Enterprise-Wide Medication Diversion
Prevention Committee.
I ask that the witnesses please stand and raise your right
hand.
Do you solemnly swear, under penalty of perjury, that the
testimony you are about to provide is the truth, the whole
truth, and nothing but the truth?
Please be seated.
Let the record reflect that all witnesses have answered in
the affirmative.
Dr. Clancy, you are now recognized for 5 minutes.
STATEMENT OF CAROLYN CLANCY, M.D.
Dr. Clancy. Good afternoon, Chairman Bergman, Ranking
Member Kuster, and Members of the Subcommittee. Thank you for
the opportunity to discuss oversight of controlled substances
and the Drug-Free Workplace Program at VA facilities. I will
address inspections to minimize diversion, drug testing for
selected employees, and our commitment to accountability for
employees who do not live up to our core values.
I am accompanied today, as you mentioned, by Mike Valentino
from Pharmacy Benefits.
GAO's recently released report on medical facility
controlled substance inspection programs in four of our
facilities has prompted a swift response. We concurred with
GAO's six recommendations and are now implementing them. Expect
them to be fully implemented by October of this year. We
conducted a conference call last week with over 450 field-based
staff to launch the action plans and to provide tools that
support that effort, followed by distribution of written
instructions. Additional dissemination efforts are planned over
the next 2 weeks.
Although GAO and VA Inspector General identified selected
instances of noncompliance with these robust controls, I
believe the system is working as designed to make it difficult
for VA staff to divert drugs and, most importantly, to give us
the tools to be able to detect diversion rapidly and take
action when it does occur.
VHA implemented robust controlled substance internal
controls in the early 1980s. In many cases, these measures
exceed those required by the Controlled Substances Act, and we
believe they align closely with Mayo Clinic's recommended best
practices.
Data from January 2nd of 2014 through March 11th of 2016
show that VA's reported controlled substances loss rate is
0.008 percent, or 8 per 100,000. And it is VA's very own
internal controls that lead to the vast majority of diversion
cases being identified.
The use of illegal drugs by VA employees is inconsistent
with the special trust placed in those who care for veterans.
The Inspector General recently reviewed allegations at the
Atlanta VA Medical Center of a backlog of unadjudicated
backgrounds investigations and found that mandatory drug
testing of new hires did not occur over a 6-month period,
resulting in a backlog of about 200 background investigations.
It was also found that the Drug-Free Workplace Program was not
administered from November of 2014 to May of 2015.
Atlanta VA leadership implemented a number of changes in
2016 in response to these recommendations, such as moving the
human resources department under the direct supervision of the
Medical Center director and developing a secondary database for
staffing and tracking all background investigations.
We expect that that backlog will be cleared by the end of
this March, and, if not, we'll keep you informed.
In addition, VA has made great strides towards improving
the Drug-Free Workplace Program. In October 2015, drug program
coordinators began certifying on a monthly basis that employees
selected for random drug testing were tested, when they were
tested, or why they were not tested.
The VA is also developing procedures to ensure the drug-
testing coding of employees in approximately 180,000 testing-
designated positions is accurate and complete. On March 1st of
2016, the Assistant Secretary For Human Resources and
Administration published a memorandum stating that 100 percent
of all applicants tentatively selected for appointment to a
testing-designated position be drug tested prior to
appointment.
VA works closely with local, State, and Federal law
enforcement entities to identify specific geographic areas with
reported mail losses, and VA's identification of loss clusters
has led to successful arrests, prosecutions, and convictions.
VA has developed a culture of controlled substance loss
reporting and has adopted a practice of over- rather than
underreporting suspected cases of diversion.
Mr. Chairman, I am proud of the health care our facilities
provide to our veterans, including prescription drug services.
The issues we're discussing here today are closely related to
our Nation's overarching struggle with opioid use. As a whole,
our Nation needs to come up with a better alternative to pain
management than opioids.
VA is at the forefront of this challenge with our Opioid
Safety Initiative, which we pioneered in August of 2013. We are
actively reducing the number of opioids we prescribe and the
number of veterans receiving these prescriptions. Instead,
we're offering a variety of complementary and integrative
medicine treatments for chronic pain, such as chiropractic and
acupuncture, among many other options. Initiatives like these
will reduce the number of controlled substances VA prescribes,
making it easier to maintain their oversight.
With support from Congress, we look forward to continuing
to improve our oversight of controlled substances and Drug-Free
Workplace Programs, which will further improve the care of our
veterans and the care that they deserve.
Thank you for the opportunity to testify, and I look
forward to your questions.
[The prepared statement of Carolyn Clancy appears in the
Appendix]
Mr. Bergman. Thank you, Dr. Clancy.
Mr. Dahl, you are now recognized for 5 minutes.
STATEMENT OF NICK DAHL
Mr. Dahl. Mr. Chairman, Ranking Member Kuster, and Members
of the Subcommittee, thank you for the opportunity to testify
today on the Office of Inspector General's work related to the
Drug-Free Workplace Program and the oversight of controlled
substances at VA facilities.
I am accompanied by Emorfia Valkanos, who is a member of
the OIG's Healthcare Inspection staff in Manchester, New
Hampshire, and is also a former VA pharmacist.
The Federal Drug-Free Workplace Program was initiated with
the goal of establishing a drug-free Federal workplace. The
program made it a condition of employment for all Federal
employees to refrain from using illegal drugs on or off duty.
VA has designated safety-sensitive occupational series as
testing-designated positions, including positions such as
physicians, nurses, police officers, and motor vehicle
operators.
In recent years, the OIG has completed two projects that
assessed aspects of the Drug-Free Workplace Program. In March
2015, the OIG issued a report detailing the results of an audit
of VA's program. We identified program weaknesses in three
areas.
First, preemployment applicant drug testing. If a tested
applicant has a verified positive test result, VA should
decline extending a final offer of employment. However, we
reported that VA did not ensure compliance with policy to drug
test all applicants selected for a testing-designated position
prior to appointment. Instead, VA selected only about 3 of
every 10 applicants for testing.
Second, employee random drug testing. We estimated VA
achieved a national drug-testing rate of 68 percent of
employees selected for random drug testing in fiscal year 2013.
In our review of 22 randomly selected facilities, we found 4
facilities did not test any randomly selected employees, 10 had
compliance rates ranging from 31 to 89 percent, while the
remaining 8 facilities tested at least 90 percent of their
randomly selected employees.
We also estimated at least 9 percent of about 206,000
employees in testing-designated positions were not subject to
the possibility of random drug testing because they were not
properly coded with a drug test code in VA's personnel system.
Those not subjected to random drug testing included physicians,
nurses, and addiction therapists.
Finally, reasonable-suspicion drug testing. We reported VA
lacked sufficient oversight practices to monitor whether
facilities referred all employees with a positive drug test
result to the Employee Assistance Program.
Based on our work, we determined VA's program was not
accomplishing its primary goal of ensuring illegal drug use was
eliminated and VA's workplace was safe. We made five
recommendations, and, as of today, one recommendation remains
open.
A more recent report focused on human resources issues at
the Atlanta VA Medical Center. During this review, we
substantiated an allegation that there was no drug testing of
employees in testing-designated positions for at least 6 months
in 2014 and 2015. Despite the lack of drug testing for 6
months, we found no indications VA management at either the
local or the national level was aware of the lapse.
Because no drug testing occurred, the Atlanta VA Medical
Center lacked assurance that employees who should have been
subject to drug testing during this period remained suitable
for employment. We made two recommendations focused on the
Drug-Free Workplace Program, and VA reported they have taken
action on these recommendations.
VA also requires that managers at VHA facilities ensure
that a controlled substances inspection program is implemented
and maintained. The OIG has reviewed VA's management of
controlled substances during our combined assessment program
reviews. We rolled up the results of our work in June 2014, and
GAO references that work in their recent report.
The OIG also has a vigorous investigative program related
to drug diversion. We primarily focus on three categories:
first, the diversion of controlled and noncontrolled substances
by VHA employees. The diversion of drugs by health care
providers for personal use is a serious issue that the OIG
diligently pursues.
Next, the diversion of controlled substances and
noncontrolled substances for illegal distribution, which
involve cases where VA pharmaceuticals are diverted or stolen
for the purpose of illegal sale.
Also, the diversion of controlled substances by a theft of
mailed pharmaceuticals. Our investigations have revealed mailed
pharmaceuticals are vulnerable to theft at any point in the
process, with the most common occurrence being theft by
employees of the mail carrier.
In conclusion, the OIG has provided crosscutting oversight
of the Drug-Free Workplace Program and controlled substances
inspections through our audits and inspections. This oversight
is necessary to ensure VA takes the steps necessary to reduce
risks to the safety and well-being of veterans and VA employees
by having and following proper program controls. We also
actively investigate drug diversion and seek prosecution for
those engaged in drug diversion.
Based on our work in recent years, we have concluded VA
lacked reasonable assurance that it is achieving a drug-free
workplace and adequately securing controlled substances.
Mr. Chairman, this concludes my statement. We would be
happy to answer any questions that you or other Subcommittee
Members may have.
[The prepared statement of Nick Dahl appears in the
Appendix]
Mr. Bergman. Thank you, Mr. Dahl.
Mr. Williamson, you are now recognized for 5 minutes.
STATEMENT OF RANDALL B. WILLIAMSON
Mr. Williamson. Thank you, Chairman Bergman and Ranking
Member Kuster and Members of the Subcommittee.
The increase in the prescribing and use of opioids over the
last two decades, sometimes referred to as the opioid
explosion, has brought with it the need for medical facilities
to undertake efforts to prevent diversion of opioids and other
controlled substances by facility employees for their own
personal use.
Diversion of controlled substances can compromise patient
treatment, can be costly to the facility, and can cause harm in
our communities for those that are the recipients of illegally
obtained controlled substances.
I am here today to discuss our recent report on VHA's
efforts to prevent diversion of opioids and other controlled
substances through its controlled substance inspection
programs.
All VA medical facilities that store and dispense
controlled substances are required to undertake monthly
inspections of all areas within the facilities that are
authorized to have controlled substances.
Each facility director is responsible for overseeing the
inspection program and appointing a coordinator to manage the
program and inspectors who conduct the inspections. Usually,
both the coordinators and the inspectors have other
responsibilities within each facility and work part-time on the
inspection program. The coordinator is responsible for ensuring
that monthly inspections are conducted and for submitting
reports to the facility director summarizing inspections and
any trends.
We found that the program was not being managed according
to VHA policy and needed improvement in certain areas.
First, monthly inspections are not always being conducted
as required. We visited four VA medical facilities across the
country and found that, over a 14-month period, one facility
missed 43 percent of the required inspections while another
missed 17 percent. The operating rooms in one facility, for
example, were not inspected at all because we were told that
the inspectors needed to arrive before or after normal
operating room hours and could not do so because of their
conflicting work schedules.
Second, when conducting the inspections, facility
inspectors did not always follow VHA policy requirements, as
was the case for three of the four facilities we visited. For
example, inspectors don't always verify that controlled
substances have been properly transferred from pharmacies to
automated dispensing machines in patient care areas; or
inspectors didn't always count all of the controlled substances
stored in patient care areas.
Third, we found that local written inspection procedures
were not fully consistent with VHA policy requirements. We
found this problem at three of the four hospitals we visited.
These three weaknesses increased the risk of diversion at
VA facilities.
We found that many of these problems were allowed to
happen, in part, due to poor oversight at the facility and
network levels. Facility directors at two of the four
facilities we visited did not consistently perform their
oversight responsibilities for the inspection program, which
include reviewing monthly inspection reports and implementing
corrective actions if missed inspections or other problems are
identified.
Also, we found that two of the four network managers who
had oversight responsibilities for the medical centers we
visited did not review facilities' quarterly trend reports, as
required. The controlled substance inspection coordinator is
required to prepare and submit these quarterly reports based on
trends identified in the monthly inspections.
Further, one of the two networks that actually did review
the quarterly trend reports took no action to ensure that one
of the facilities in our review that had not prepared quarterly
trend reports had a corrective action plan to do so in the
future.
Aside from the oversight weaknesses, we found that there is
limited training for coordinators to better ensure that they
have a complete and detailed understanding of VHA's inspection
procedures.
Finally, two of the facilities we visited had backup
coordinators to help manage the inspection process and complete
inspections when the primary coordinator or inspectors could
not carry out their responsibilities because of pressing job
duties or unforeseen circumstances. We recommended that VA
adopt this type of practice systemwide, and VA concurred. VA
also concurred with our five other recommendations to improve
the process and provide better oversight.
This concludes my opening remarks.
[The prepared statement of Randall B. Williamson appears in
the Appendix]
Mr. Bergman. Thank you, Mr. Williamson.
Dr. Berge, you are now recognized for 5 minutes.
STATEMENT OF KEITH BERGE, M.D.
Dr. Berge. Chairman Bergman, Ranking Member Kuster, and
Members of the Subcommittee, thank you for the opportunity to
speak with you today about drug diversion from the health care
workplace. Such diversion is a crime that endangers all
patients, health care employers, coworkers, and even endangers
the diverters themselves.
While we have long known of these hazards of patients being
deprived of pain medication by diversion, only fairly recently
has the grave risk to extremely vulnerable patients been
revealed by outbreaks of disease, such as blood poisoning by
bacteria or viruses that have been transmitted by drug
diverters swapping syringes in the commission of their crimes.
In the process, many patients have been infected with
potentially fatal illnesses.
I have attached for your review a paper authored by the CDC
investigators outlining six such outbreaks over a 10-year
period that resulted in illness and death in patients.
One of these diversion infection scenarios included
Veterans Affairs patients being exposed to a diverter that
communicated his hepatitis C infection to approximately 50
patients. This individual was referred to earlier in the
introduction comments. This diverter was a radiation
technologist who traveled the country, working for multiple
employment agencies. He had been fired from multiple jobs for
diverting fentanyl for his own use, but by simply lying about
previous terminations on job applications and in the absence of
a national registry of radiation technologists, he had no
trouble finding employment.
In the darkened invasive radiology suites, he would swap
fentanyl syringes on the anesthesia cart with ones he had
previously used to inject himself. He would then excuse himself
to a restroom, inject himself with the stolen fentanyl, draw up
tap water, and repeat the process with the next patient's
fentanyl. In this manner, he conveyed his potentially lethal
illness to many innocent victims.
The patients described in these eight outbreaks were all
extremely vulnerable positions, either undergoing an invasive
procedure while under anesthesia or while in an intensive care
unit.
Clearly, such behavior is unacceptable. In recognition of
these dangers posed by diversion, the Drug Enforcement
Administration requires stringent drug control policies and
procedures to be put in place to protect controlled substances
from attack across all points of the manufacturing,
distribution, dispensing, administration, and disposal
spectrum.
The drugs used in the health care setting are highly
sought-after drugs of abuse, both by addicts and by those who
would profit richly from the sale of stolen drugs. Experience
at the Mayo Clinic and elsewhere has shown the necessity of
having robust surveillance, detection, investigation, and
intervention programs in place in order to minimize the risk to
all involved.
While it will impossible to completely eliminate drug
diversion from the health care workplace, it is imperative that
robust systems rapidly detect and halt such activity. I have
attached for your review an article from the Mayo Clinic
authors, myself included, which outlines our program from its
inception through its very successful implementation.
While we continue to try to improve our system, it has
proven quite effective in identifying a host of drug diverters
since implementation 7 years ago. Diverters come from diverse
backgrounds and include physicians, pharmacists, pharmacy
techs, nurses, nursing students, nursing assistants, janitors,
patients, patient family members, nursing home attendants,
hospice workers, and strangers off the street.
These stories are incredible, but they all point to the
powerful draw that these drugs have over addicts. As such, it
is not good enough to merely have effective policies and
procedures on the books; they must actually be rigorously
followed.
Diverters are generally clever and desperate, and they will
gravitate into areas of a system where they perceive the drugs
to be most vulnerable to attack. It therefore behooves any
health care facility to have a reputation for being effective
at rapidly identifying, terminating, and prosecuting drug
diversion and drug diverters. Only by doing so can we protect
the most vulnerable of our patients from preventable harm.
As I've stated, this problem will never go away, so we must
become very good at rapid intervention. Only by instituting and
following effective antidiversion policies and procedures will
this be possible.
I thank the Committee for its attention to this very
important issue and stand ready to answer any questions you may
have. Thank you.
[The prepared statement of Keith Berge appears in the
Appendix]
Mr. Bergman. Thank you, Dr. Berge.
The written statements of those who have just provided oral
testimony will be entered into the hearing record.
Mr. Bergman. We will now proceed to questioning.
Dr. Clancy, in your testimony, you state that the VA
performs an actual count of all controlled substances every 72
hours. Who performs these counts, and who oversees that these
counts actually occur at each facility?
Dr. Clancy. So what I saw when I made a more or less
unannounced visit to the D.C. VA last week is that pharmacy
techs who are working in the vault are doing that, and they are
double counting as they're doing it. So, in other words, there
are two assistants who are each verifying, because counting a
lot of pills is prone to missing one and so forth. And that is
further verified by a supervisor.
Mr. Bergman. Given the weaknesses identified by the OIG and
more recently by GAO, how can VA central office be sure that
these counts are taking place and that they are accurate? You
observed one.
Dr. Clancy. Yes. Well, I think that Dr. Berge just said it
well. We have very good policies in place, but it's very
important that they are rigorously followed. So we are
exploring right now how we might do some backup audit to make
sure that those policies are followed.
As I mentioned in my opening, we actually have already
disseminated written statements to the field. I would be happy
to make a copy of that memo available for the record or just
for your interest.
But, again, it's very, very important to know that this
actually happens, that our aspirations are as good as what
we're delivering on.
Mr. Bergman. Thank you.
Dr. Clancy, how many cases of drug diversion has the
Controlled Substance Inspection Program identified in the last
2 years?
Dr. Clancy. So what I have here is a poster, which we could
make available to the Committee--Mike, if you could just turn
that around--of controlled substance losses by type.
So the data that we looked at specifically goes from
January 2nd of 2014 to March 11th, I believe, of 2016. What you
see is that 91.4 percent of these losses occur outside our
facility in the mail system. And that leaves about 1.5 percent,
I believe, from employees internally.
But, again, this is something that we're checking all the
time. And if there's any question whatsoever, VA police are
engaged, as well as the Inspector General's Office, and they've
been most helpful.
Mr. Bergman. And of those losses that occurred at VA
facilities outside of the loss in the postal, will you be able
to provide the Subcommittee a list of those facilities where
the drugs have been reported missing or stolen in the last 2
years?
Dr. Clancy. We would be happy to do that.
Mr. Bergman. Okay.
Mr. Williams, what is the role of the medical center
directors in terms of ensuring inspections and proper
oversight?
Mr. Williamson. Well, they are key at the facility level
for reviewing the monthly inspection reports, identifying any
issues that arise, such as missed inspections, inspections that
are not done correctly and other things that the coordinator
reports to them. And they then are responsible for holding
staff accountable and developing corrective action plans.
Mr. Bergman. I see I've got about a minute left here.
Dr. Berge, VA's Office of Human Resources Management
reported to the OIG that they interpreted language in the VA's
Drug-Free Workplace Handbook to require only some job finalists
for testing-designated positions to be drug tested before being
appointed.
Would this be an acceptable practice in your health care
organization?
Dr. Berge. I believe in our health care organization we do
post-offer-of-employment testing on all applicants.
Mr. Bergman. And what are the consequences for hiring
health care workers prior to drug testing or completing
background checks?
Dr. Berge. Well, you might be letting the fox in the
henhouse. You might be letting somebody who would test positive
and is, in fact, an addict into an area where they can get
their hands on drugs.
There's an example of that in the Denver area within about
3 years ago. Kristen Parker, she is now spending 30 years in
Federal prison for infecting about 36 patients with her
hepatitis C. But, in retrospect, she was a heroin addict that
took a job in a facility and started diverting fentanyl.
Mr. Bergman. Thank you.
Ranking Member Kuster, you are recognized for 5 minutes.
Ms. Kuster. Thank you, Mr. Chair.
Thank you to our panel. I particularly want to thank the
GAO and the IG for their helpful reports.
I want to focus in on evidence demonstrating we know what a
successful drug diversion deterrence program would look like,
and yet we continue to have this problem at various VISNs.
My question is: Currently, the VA gives authority to the
individual facilities to implement these inspection procedures.
Is there any reason--and I guess this is for Dr. Clancy--why
the VA could not streamline this process and apply one standard
to all facilities and, in fact, have an inspection team based
out of the central office that would go out to the VISNs?
It seems what I'm hearing is that this is often just an
added task. In fact, in one case, it was somebody who was a
food services worker, that this was just an add-on. It doesn't
seem as though we're taking it sufficiently seriously.
And wouldn't it make more sense if we had an office of
inspection that would then go out to the VISNs perhaps, as you
did yourself, without advance warning and do these checks?
Dr. Clancy. Thank you, Congresswoman. That's exactly what
we're going to be looking into. And I think what we need to
look at is how much of this could be done remotely, how much of
it requires on-site presence, and, frankly, how much can we
identify ahead of time which facilities are likely to have the
most challenges.
I suspect that in some instances--but we need to test
this--we will know which facilities are more likely to be
compliant. I guessed correctly which one was the facility in
the GAO report based on many, many other things I knew about
that particular facility. And I wasn't incredibly surprised by
the distribution of the others.
But we need to actually up our game and make sure that
great policies are implemented consistently. There's no
question about that.
Ms. Kuster. And at least have consistency. What I'm curious
about is having a system that would be consistent throughout.
So I have got a couple minutes. I want to return to the
issue of reducing the amount of opiate medication generally in
the VA population. We had testimony from a medical researcher
that, out of the 60,000 surgeries a year, 99 percent of people
get opiate medication, and 1 in 15 will become a chronic user
of opiates. That's what is feeding this epidemic.
Can you talk to me more about both the program within CARA,
encouraging VAs to reduce the use of opiate medication, or any
other examples that you might have in the system?
Dr. Clancy. Of course. And thank you for the question.
I'm happy to report that we are on track for all the
provisions in CARA. Incredibly enough, VA's portion of that is
named for a veteran who died under our care. And I was
literally speaking with his father yesterday, and I have been
most impressed by the family honoring the experience of their
son by working with us to make sure that we provide better
care.
VA has really been on the forefront of reducing the use of
opioids. So, beginning in August of 2013, we've seen a 31-
percent reduction in the number of patients receiving opioids.
We've seen a 56-percent reduction in the number of veterans who
are receiving an opioid and another type of drug which has a
particularly high risk for adverse reactions.
We are doing much more frequent urine testing, because
we're trying to minimize diversion from patients, veterans
actually selling the drugs that they got at VA to elsewhere. So
the right answer on a urine drug screen is positive, that
you're actually taking the medications you received.
We're seeing the overall dosage of opioids has decreased
quite significantly for--and we've also seen--we have seen
these results at a time when we've seen an overall growth in
the number of veterans we are serving.
I want to be clear: We're not done, and we will continue to
monitor this. And I'm very proud of the work that we are doing
to offer veterans alternatives to chronic pain management.
Ms. Kuster. My time is up, but I would just say to the
chair that, as we continue, I would love to have further
testimony about the chronic pain programs and how we can bring
down the use of opiate medication.
Thank you.
Mr. Bergman. Mr. Bost, you are recognized for 5 minutes.
Mr. Bost. Thank you, Mr. Chairman.
And, Dr. Clancy, I'd like to continue down that same path.
The Ranking Member actually asked the first part of the
question I was going to ask, but I still want to go down that.
And that was, okay, the report from 2009 and then again in 2014
on the weakness that the VA Controlled Substance Program had,
now, you kind of explained what the VA central office was
doing, but what about the VISN and at the faculty level? What
are we doing there?
Dr. Clancy. So every one of our networks that's a Veterans
Integrated Service Network has a pharmacy lead there. I will
say that it's my understanding that there's some variability in
terms of how many other members of the team that they have.
Many of them are quite strong in terms of reviewing facility
reports and providing that kind of oversight. Others, it's my
understanding, are less so. I'd be happy to provide more detail
for the record.
But I think that we need a very consistent approach: here's
the facility's responsibility; here is the second line, which
should be the network; and then central office providing what
is sometimes referred to as the third line of defense. I'm
quoting from, sort of, accepted practices in internal audit,
which is an area that we have just started up within my group.
Mr. Bost. Okay. And I know that you've been trying to do
that since the 2014 report, but why do you suppose that when
all of a sudden the GAO came back, many of those same
weaknesses showed up again? What are we not doing correctly to
move quick enough to try to deal with this?
And it is getting to a point of epidemic, and not just in
the VA. It's nationwide, the epidemic that we're dealing with.
But we have to set the example.
Dr. Clancy. I would agree. And that's precisely how we
think of it, as setting an example.
I think, to some extent--I believe it was Mr. Williamson
referred to the fact that some of these coordinators have
collateral duties. I do note that, for many of our facilities,
anesthesia and the operating rooms tend to be areas, probably
because of the hours, where there have been problems conducting
inspections.
Every facility in our system has been directed, redirected
quite recently, to have a backup coordinator.
My colleague from pharmacy who's here today--not Mr.
Valentino, one of his top lieutenants--came with me the other
day, and he noticed that maybe there was a little problem with
not randomly conducting the inspections throughout the month.
If you let it go till the end of the month, which is
understandable--but, nonetheless, if, you know, stuff happens
that week, that means you will have slipped a month and so
forth.
So that is the kind of thing that I think we can and will
improve on.
Mr. Bost. My next question is for Mr. Dahl.
In your investigation related to the 2015 and 2017 reports,
how many positions identified as no background check completed
were the high-risk or the testing-designated positions? Do you
know that?
Mr. Dahl. Well, the 2015 report did not get into the
background investigations. Our 2017 report, which was focused
only on the Atlanta VA Medical Center, I wouldn't have that
information at hand, but I'd be happy to look into that.
Mr. Bost. Can we get a copy of that to try to figure that
out? Because we want everyone tested, because, as you
described, somebody at the panel did, that everyone is at risk
with this, anyone we hire. That being said, if we're going to
drop them into those high-risk positions, we've definitely got
to do some backing up and making sure.
And I'm kind of short on time here, but, Dr. Berge--and
this is a question that I'm sure my constituents and people
throughout this Nation are going to ask, would your health care
organization hire a clinic professional prior to completing a
background check?
Dr. Berge. No.
Mr. Bost. That's what I thought.
Okay. What risks are associated with hiring a clinical
staff prior to a background check?
Dr. Berge. Well, one source of frustration is, like, when
we are interviewing an applicant for, say, our nurse anesthesia
school, that employment law forbids us to ask, have you been
through treatment for chemical dependency before? Well, we have
had such people come in that developed fentanyl addiction and
then, in retrospect, well, they've gone through treatment for
cocaine abuse in the past.
So, in some ways, we're barred from asking some of those
questions. But we would complete the post-offer-of-employment
drug testing.
Mr. Bost. And if I can just add, first off, let me say
this--and I know I'm running short on time, Mr. Chairman--but
this is an issue I've dealt with on a State level and then here
at this level as well. The one thing we want to remember is how
vitally important those tests are, because this disease--and it
is a disease to be an addict.
I had a friend that, one time, when we begged him to talk
to us, he gave us an information, it wasn't correct, and he
came back and said to us, what part of I'm an addict, I lie,
don't you understand? That's why it's so vitally important to
not only do the question but make sure that we do the followup
checks.
And the concern I see is the holes that are existing in the
system. We can't have it--we want to do everything we can to
empower you to try to stop this epidemic that is affecting--and
it doesn't matter what your race is, what your gender is, what
your socioeconomic status is. We've got to continue to work on
this.
So thank you very much.
Mr. Chairman, I yield back.
Mr. Bergman. Thank you.
Mr. Walz, you are recognized for 5 minutes.
Mr. Walz. Thank you, Mr. Chairman.
And thank you all for being here.
Dr. Clancy, you and I have a long history in this too. Just
for the Committee's sake, for the new members, the first piece
of legislation that we authored in 2008 was the pain directive
that went to the VA to set up the step pain management. That
was with a lot of work that came in from the folks from the
Mayo Clinic, from Boston Scientific, and all of the best
practices, working in conjunction with the VA. This is one of
those issues that the seamlessness between the private sector
and the VA is pretty strong. We all have the same issues.
But my colleagues were getting at it, and the Ranking
Member knows this, the fundamental issue here is pain
management. It's in the beginning, and our Nation goes through
these cyclical issues of issuing opioids, pulling them back,
which creates its own problem.
The diligence on the control side, we can always do better
on that. And I think there's been some great suggestions there.
But I would suggest to all of us--that program, am I right, Dr.
Clancy, was never fully implemented? We had this discussion out
in Tomah, Wisconsin, here about 18 months ago. Did we ever
fully implement it before it expired?
Dr. Clancy. I'm not sure, but I could get back to you on
that.
What I do know is, thanks to the new legislation that
Representative Kuster was asking about, the CARA bill, we are
now making sure that there is pain management expertise and
teams accessible by all our facilities. For some of our
facilities, that's going to be partly virtual, but, you know,
as an integrated system, we can do that--
Mr. Walz. But it builds on that same principle--
Dr. Clancy. Absolutely.
Mr. Walz [continued].--and fully implemented the same thing
that's happening in the private sector. Because most of us
know, as the VA goes, so goes the rest of the system in a lot
of ways, just because of the sheer volume of this.
How much collaboration, Dr. Clancy, do you have with, like
Dr. Berge, experts that are out there?
Dr. Clancy. Well, I am just meeting Dr. Berge today,
although we have a mutual colleague friend. But we consult with
others pretty broadly. And, in fact, when the CDC published
their guidelines on opioids last year, they drew on expertise
from a number of folks in the VA, including from your district.
Because, as you said, this is all about a common health
challenge shared by the country.
Mr. Walz. Dr. Berge, again, thank you for being here. And
you and your colleagues over the years have--I think the thing
about this is to not think everything is reactive, and this
recent opioid epidemic and the overdoses and everything else
that come with it, that that was not a surprise to many folks
like yourself.
But when you said Mayo Clinic saw that you had maybe some
holes in there, you decided to turn around, and now recognized
as one of the best, how long did it take you to implement that
before you saw or expected to see change?
Dr. Berge. We were probably about a year and a half in
creating our system. And that was in response to a tampering
diversion that ended up on the front page of the newspaper and
embarrassed us. We tried to work through every spot in the
supply chain where we were vulnerable and figure out a plan to
address that. And it takes some time to go through that
process.
Mr. Walz. And you have facilities--how many facilities?
Dr. Berge. Well, we have the Midwest, the Minnesota
facility and surrounding area. We also have Jacksonville,
Florida, and some small surrounding area; and Scottsdale,
Arizona, and some surrounding area.
Mr. Walz. So the numbers, you have 50,000-plus employees,
roughly?
Dr. Berge. About 70,000 employees.
Mr. Walz. About 70,000 for the entire system on that, so
this is a big health care system that's been able to--I think
one of the maybe frustrations--and I know it frustrates you
too, Dr. Clancy--is sometimes the slowness of the reacting to
these situations as the bureaucracy takes time.
You're feeling comfortable now, Dr. Clancy, that there is,
with the new legislation, with the emphasis on this, with the
situations that come up that are unacceptable--and the thing
is, as I think for many of us, we know that what's happened in
these situations that have been brought to light are happening
in the private sector. Our responsibility is the VA. Our
responsibility, both from an oversight and a legal
responsibility but also from an ethical responsibility, is to
those veterans.
Do you feel like it's moving quickly enough for you?
Dr. Clancy. I'm excited by how enthusiastic our employees
are about this. I mean, this is a national problem. I'm excited
by the progress we've made. But we will be tracking this very,
very closely.
Mr. Walz. Because I get it too. They're embarrassed by
this. We recognize that when it's not done right--the issue
in--the surrounding areas impacted it. This is a tragic
situation.
I guess the news for all of us in here is we can do
something about it and do something quickly, because we have
that ability in the VA. And I guess I'm just looking to see
these things maybe be implemented as quickly as we can, and I
know you are too.
And I thank you all for your testimony.
Mr. Bergman. Thank you.
Mr. Poliquin, you are recognized for 5 minutes.
Mr. Poliquin. Thank you, Mr. Chairman, very much.
Mr. Dahl, you're with the Inspector General's Office,
correct, sir?
Mr. Dahl. Yes, sir.
Mr. Poliquin. And, Mr. Williamson, you're with the
Government Accountability Office?
Mr. Williamson. Correct.
Mr. Poliquin. Okay. Great.
You two gentlemen, please, the last 8 years or so, you've
repeatedly reported that there's a problem with keeping track
of the drugs at the VA facilities, making sure they're not
stolen and sold and so forth and so on. Is that correct?
[Nonverbal response.]
Mr. Poliquin. Okay. So would you both conclude that we
still have a problem?
Mr. Dahl. I'm sorry, I missed that.
Mr. Poliquin. Would you conclude that we still have a
problem?
Mr. Dahl. I would think that, based on GAO's recent work,
that there is still an issue.
Mr. Poliquin. Thank you.
Dr. Clancy, you are the Deputy Under Secretary for Health
for Organizational Excellence. What does that mean? Does that
mean, in part, keeping track of who's got these harmful drugs
and make sure they're not put in the wrong hands?
Dr. Clancy. What it means is providing oversight for
quality, for safety of care, and for integrity.
Mr. Poliquin. Okay.
Dr. Clancy. And integrity is about compliance with the
stated policies.
Mr. Poliquin. Okay. What person at the VA, Dr. Clancy, what
one person is responsible for this problem? Who's the head
banana?
Dr. Clancy. That would be the Under Secretary for Health.
Mr. Poliquin. Who's that?
Dr. Clancy. Right now, that is someone in an acting
position, Dr. Poonam Alaigh. You know that our Under Secretary
was recently confirmed as Secretary.
Mr. Poliquin. Could you spell that name for me, please?
Dr. Clancy. A-l-a-i-g-h.
Mr. Poliquin. Okay. And you report to that person, that
individual?
Dr. Clancy. What?
Mr. Poliquin. You report to that individual. Is that
correct?
Dr. Clancy. Yes.
Mr. Poliquin. Okay.
When someone is caught, Dr. Clancy, stealing drugs and
selling them or making them available to folks that shouldn't
have them, like our veterans that we're working so hard to
help, what action is taken?
Dr. Clancy. It depends on the specifics of the
circumstances--
Mr. Poliquin. Do you call the cops?
Dr. Clancy. Yes.
Mr. Poliquin. You do. Good. Okay.
And what sort of actions recently have taken place in the
system that you can share with us about people being held
responsible for this abuse?
Dr. Clancy. I think you have probably seen from newspaper
articles that a fair number of people that we have brought to
the attention of law enforcement have, in fact, been convicted
and are serving time. They're paying their debt to society. And
we would be happy to get you a whole list for the record.
Mr. Poliquin. That would be great. We will make sure we get
that list. Thank you very much.
Integrated services networks, who are they and what do they
do? And how are they involved in this?
Dr. Clancy. So we have facilities--that is hospitals,
clinics, and so forth--all over the country, including Alaska
and Hawaii and Guam and even a clinic in Manila and so forth.
So a big, big span of reach. And so the system is organized
into these networks. This is sort of a submanagement model.
Mr. Poliquin. Okay. And what does the integrated service
networks do?
Dr. Clancy. They manage and provide oversight for the
facilities and clinics in that particular area.
Mr. Poliquin. Okay. So they'd be responsible also for
making sure that we have a good headcount, so to speak, on
where the drugs are and where they're being dispensed, correct?
Dr. Clancy. Yes.
Mr. Poliquin. Okay. Good. And who's the head person over
there?
Dr. Clancy. There are 18 of these networks. So, in your
area, that would be Dr. Michael Mayo-Smith for New England.
Mr. Poliquin. Okay. We'll make sure we get a list of these
people also.
Mr. Williamson, have you found in traveling around the
country and dealing with separate VA facilities that there is
inconsistency--and I think Congresswoman Kuster asked this
question earlier; I want to make sure I get it straight--there
is inconsistency in which organizations, which medical
facilities actually do a better job than not in following these
protocols?
Mr. Williamson. Absolutely.
Mr. Poliquin. Okay. How do you fix that problem?
Mr. Williamson. There was one facility that we looked at
that did everything right, and what was going on there was
commitment and leadership from the medical director right down
to the inspectors. And that's what you need. It's a culture--
Mr. Poliquin. So there is an example at the VA that this
can be done correctly.
Mr. Williamson. Yes.
Mr. Poliquin. Okay. And what would you guess, what
percentage of the VA facilities around the country are doing
this well?
Mr. Williamson. Ten, 15 percent.
Mr. Poliquin. Ten or 15 percent.
So, Mr. Chairman, there are 85 percent of the VA facilities
around the country who are dispensing drugs illegally or at
least in a hurtful way, correct?
Mr. Williamson. I wouldn't say dispensing drugs illegally.
They're not following the tenets of the inspection process.
Mr. Poliquin. Okay. And, as a result, these drugs get in
the wrong hands.
Mr. Williamson. Correct.
Mr. Poliquin. Okay. Good.
Dr. Berge, you're in the private sector over at Mayo,
correct?
Dr. Berge. Correct.
Mr. Poliquin. Okay. At least you're outside the government
sector.
Dr. Berge. Correct.
Mr. Poliquin. Good. Have you found that with an effective
drug control program that you can save money?
Dr. Berge. I believe we can. I believe if you were to ask
the executives of the Exeter, New Hampshire, hospital that's
being, you know, sued, you know, multiple lawsuits, that they
wish they had a more effective system in place.
Mr. Poliquin. Besides avoiding litigation, is there a way
to save money when you have an effective program like this?
Dr. Berge. That's extremely hard to quantify, I think. I
mean, to have an effective system in place is not an
inexpensive endeavor in itself. But it allows you to--we have
heard that the word on the street is don't go to work for Mayo,
because if you're going to steal drugs, they'll catch you.
Mr. Poliquin. Gotcha. Thank you.
Thank you very much for being here.
Mr. Chairman, thank you very much.
Mr. Bergman. Thank you.
Dr. Dunn, you are recognized for 5 minutes.
Mr. Dunn. Thank you, Mr. Chairman.
Dr. Clancy, I serve a constituency that actually has a
veterans hospital, the Lake City facility. And there was
testimony here that we did not read aloud but I think you're
familiar with that they had a problem in the Lake City facility
recently with a nurse misappropriating drugs.
Can you discuss the corrective actions and protocols that
have been established at that Lake City facility in the wake of
this incident to restore the quality of care and the level of
workplace safety for the community?
And, also, tell me if your current controlled substance
coordinator in that facility is properly certified and educated
on the management of controlled substances and the supply chain
and the management policies.
Dr. Clancy. I would be happy to take that for the record.
Our first focus was on protecting patients and then holding the
individual accountable. But I will get the rest of the
information--
Mr. Dunn. Okay. So you're not familiar with that particular
incident in the Lake City facility?
Dr. Clancy. I am familiar with the incident. I'm not
familiar with all of the details of the followup. But we will
find that for you.
Mr. Dunn. All right.
Let me depart for a second. Dr. Berge, you're an expert in
substance abuse, I think, and how it comes to pass. I'm a
surgeon, and I've managed operating rooms, I've directed
hospitals and, you know, large clinics. And this is a problem
we all have to address. It's just part of the job that we have
to do when we do health care.
Mr. Dunn. And I've seen this studied at the State level as
well. I'm looking at this particular pie chart here that
suggests that 90 percent of the problem with diversion with
controlled substances is occurring not in the health care
facilities, but in the United States Postal Service and in UPS.
Now, I want to tell you that I've looked at a lot of drug
diversion, a lot of problems with this in my 35-year career as
a surgeon, I have never seen anything like this reported. This
is perilously close to the old excuse, the dog ate my homework.
Do you believe that 90 percent of the problem of drug diversion
in this country occurs in the United States Postal Service?
Mr. Berge. I'm not really qualified to comment on that
because that's not where we see it. I'm basically assigned to
within the walls of our healthcare facility, so what happens
without, I don't know. That's not what we see at Mayo, we see
other forms of diversion.
Mr. Dunn. Perhaps I should redirect that question, Dr.
Clancy, and say, do you mean by this that the 90 percent of the
problem occurs in the Veterans Administration facility mail
rooms? Or are you actually saying that employees of the United
States Postal Service, and the United Parcel Service, or people
who victimize them are getting 90 percent of the diverted
drugs?
Dr. Clancy. What I am saying, and I'll ask my colleague to
elaborate, is that between the time the prescriptions are put
in an envelope, and understand that we have a central mail
order pharmacy which, for most prescriptions, works
extraordinarily well, it does a high order of business, very
large volumes. Somewhere between there and the veterans home
where it was supposed to go is where it is diverted. On
occasion, we've heard from veterans that that's actually
diverted by a family member and so forth. But it could be any
one of those points and that's where working with the inspector
general, VA police, and outside law enforcement has been very
helpful.
Mr. Dunn. Okay. So let's drill down on this a little bit
farther, because this looked like they were laying it off on
the Postal Service. What's happening is the VA is taking--
getting receipt of the drugs from who they purchased from, and
then they are distributing it in their system. Now they may be
using UPS or USPS, and somewhere between once the VA has the
drug and the VA passes it off to another part of the VA, the
drugs are being diverted. Is that the system?
Dr. Clancy. No, this is outside the VHA system.
Mr. Dunn. So I have to tell you, 35 years, I've never heard
this kind of accusation, 90 percent of the problems in the
postal system, I'm flabbergasted, Mr. Chairman. And let the
record reflect my incredulity.
Mr. Williamson. Dr. Dunn, we looked at this. One of the
first things that we tried to obtain was good data. I would be
very suspicious of the VA data because drug losses are not
always synonymous with diversion, so one has to be careful of
that. But the reporting system, VA doesn't have a good
reporting system for drug diversion cases, so I would be very
suspicious of this VA data.
Mr. Dunn. I am too. Thank you.
Mr. Bergman. Thank you.
Dr. Roe, you're recognized for 5 minutes.
Mr. Roe. Thank you, Mr. Chairman. I want to go along with a
little bit of what Dr. Dunn was doing. Obviously, we know that
there's a drug epidemic, and certainly in the State of
Tennessee I live in, it is. Is there any data on how many
veterans die of drug overdose deaths by both with Diazepines
and with opioids? Dr. Clancy, do you have any information on
that? How many of our veterans?
Dr. Clancy. We do track that very closely, and we would be
happy to get that for you for the record.
Mr. Roe. The other thing I have, as I looked at this graph
more, I couldn't figure out you determined 90 percent. I mean,
if somebody is home and just said I didn't get my drugs. Look,
one good thing, if there is any good thing about an electronic
health record, what used to happen to us when we would close
our office at 5 o'clock, people would start calling in and ask
about, Well, I just had surgery--we had a big practice--2 weeks
ago, and Dr. So-and-so didn't leave me enough medicine, I need
you to call me a prescription in. The EMR, I'd just pull it up
and say, well, you don't seem to be a patient in our practice.
People are very clever at being able to get drugs. How many--
when you say 90 percent, how in the world could you ever figure
that number out, because you say here that the Post Office
doesn't deliver it. How do you know that?
Mr. Valentino. I can help with that. This is based on a
sample of reports from January 2014 through March of 2016. So
whenever we have a loss, we have a template that the individual
facility fills out. What happened? Who did you report it to?
DEA, OIG, VA police and security and so on and so forth. In
those reports, we're able to glean information and identify if
it was a situation where a VA staff member diverted a drug, or
whether it was a patient calling and saying, I didn't get my
package. And our packages are sent with tracking information.
So we can tell where it is in the delivery stream. And at
some point, if the patient says they don't get it, we have one
of two situations: either they did get it, or a family member
got it, or it went missing somewhere. So these are--I agree,
these may not be diversions, but these are indeed lost reports
that are generated--
Mr. Roe. I'm sorry to interrupt you, because my time is
short. But it looked to me like, if we can know how many died,
if there is a real problem, looks like there may be a better
way to deliver these medications to people, than sending them
out in the mail. I mean, if that's where nine out of 10 of
these problems are, and we're losing a lot of people, it looks
to me like that's a sloppy system, if that's the case.
Anyway, Dr. Clancy, in your written testimony, you said 92
percent of--get lost by mail, and you sort of answered about
how you got at that information. And in viewing the DEA forms
106 submitted to the Committee, we learned of instances where
VA mailed controlled substances to the wrong address, and
worse, to the wrong veteran. How many cases from the 92 percent
that were missing in the mail were those delivered to the wrong
address or to the wrong person? That's really sloppy.
Dr. Clancy. We would be happy to get that for the record.
Mr. Roe. Well, just--and we appreciate that. And please
take that for the record and note that the numbers--and bring
those numbers to the Committee. And for now, what's the VA
doing to ensure that they get the right prescription? That's
just sloppy work when you mail it to the wrong address, or to
the wrong person, for goodness sakes.
Dr. Clancy. There's a big part of the effort initiated by
Secretary McDonald and my VA transformation that includes
making sure that veterans data is integrated from multiple
sources, because after all, many veterans get multiple services
from us, so that when they move, change phone numbers or
whatever, we've got accurate information. Everything that is
mailed out is bar-coded so that it can be tracked. So if a
veteran calls up a facility and says, My medications didn't
come, they can actually track it, there's a tracking number,
whether it's Postal Service or UPS. And ultimately, that's
helpful in law enforcement in figuring out what happened.
Mr. Roe. But is that a system we want to continue at the
VA? Because the VA is a huge system, and treating millions of
people, and not thousands, but millions.
Mr. Valentino. So you're right, absolutely right that this
is an area where it's not working as well as it should. If we
required every veteran to come in to pick up their controlled
substances, we could certainly do that, I think it could create
some unintended consequences, some of our veterans live very
far away. So we may have to look at other options for them to
get their controlled substances.
Mr. Roe. Now I agree with that, it would do that. I'm not
saying that you should do that. We have a situation now where
there's 30-something thousand people, these are all deaths that
are preventable. It is really disturbing to me, that when you
have probably as many people die of drug overdose deaths as car
wrecks now, so it is a huge problem for the entire country.
Mr. Chairman, I yield back.
Mr. Bergman. Mr. Poliquin is recognized for one follow-on
question.
Mr. Poliquin. Thank you very much, Mr. Chairman. I
appreciate it. I would like to follow up on what Chairman Roe
was just talking about. It's clear to me and I think everybody
in this room that the VA, and God bless them, they are doing a
horrible job when it comes to this issue. Why in the heck do we
have to dispense the pills from the VA? How many pharmacies do
we have in this country? I don't know, Doctor, I mean we have a
bunch of them, right? Why in the heck can't we have pharmacies
around the country closer to where our population is, where our
veterans are, why don't they dispense the pills, if you guys
are doing such a horrible job? Dr. Clancy?
Dr. Clancy. I'm sure, as my colleague noted, first of all,
mail order works extraordinarily well for other types of
medications, and as we work through how to reduce this area of
vulnerability, there may be a lot of other options that we
could consider.
Mr. Poliquin. Good. So, in other words, what you are saying
if you're getting an aspirin or something like that, it will
probably make sense, but a controlled substance. Maybe it's
better if it's closer to home, right, where folks come in and
they are known by the folks at the pharmacy, and you know,
we've got a problem here, so forth and so on. Why not? I think
we ought to consider that. I don't know what the protocol is,
Mr. Chairman, I bet these nice folks can come back to us at
some time and report back to us. I would like to follow up, if
I can, along the same vein, is that Mr. Dahl and Mr.
Williamson, my eyes are bad, it's Mr. Williamson, right? Great.
You two fellows said that roughly 10 or 15 percent of the
medical facilities in the VA are doing this right. That means
there are 80, or 85 percent, or 90 percent--
Ms. Williamson. That's what I would--we only looked at
four, and the IG looked at 58, but that's based on, you know,
some--
Mr. Poliquin. There are a bunch of them that are doing it
wrong?
Ms. Williamson. Excuse me?
Mr. Poliquin. There are a bunch of them that are doing it
wrong?
Ms. Williamson. Correct.
Mr. Poliquin. I have an idea, Mr. Chairman, why don't we
get you nice folks to talk to our great staff here, and find
out who's doing if right? And we'll have our staff, Mr.
Chairman, call up the folks that are doing it right, and let's
find out why they are doing it right, and then maybe we can
have this nice person, Mr. Alaigh, who, I believe, Dr. Clancy
report to, who would be the Under Secretary for Health
Organizational Excellence, have him come before the Committee,
and then we can see, okay, we've had these folks that are doing
it right, now we're having a problem at the VA doing it wrong.
Maybe you can tell us why 80 percent are doing it wrong. It's
just an idea. What do you think about that, Mr. Dahl, do you
think that would work?
Mr. Dahl. I missed that last part, sir.
Mr. Poliquin. Do you think that would work? Would that give
us a little bit of help to the folks that are doing it wrong?
Mr. Dahl. Best practices, it wouldn't hurt to share them.
Mr. Poliquin. There you go. We are all trying to get this
right, because we have a lot of veterans who are in pain, and
we got a lot of folks that are having problems with opioids and
heroin, including the Second District of Maine that I'm very
concerned about. So anything that we can do to help you folks,
we'll do that. And I know our great staffer, Kate, will be in
touch with you folks to get the names that we talked about.
Yes, Doctor.
Dr. Clancy. I just wanted to make the point that we often
do do sharing of best practices and have a big initiative on
that now, and I think it is a splendid idea to--
Mr. Poliquin. Have you been doing that for the last 8
years?
Dr. Clancy. Not in this particular area. We have focused a
lot on reducing opioid use.
Mr. Poliquin. The last year, the last 2, or the last 3?
Dr. Clancy. The last couple of years.
Mr. Poliquin. The last couple of years. But you still have
about 80 percent not doing it right?
Dr. Clancy. I am not quite as confident. I think that may
be a slightly pessimistic projection, but I will tell you when
we look, I will let you know.
Mr. Poliquin. Thank you. Even more, Mr. Chairman, more
reason for us to get the folks who are doing it right to come
and report to us and maybe have the person who is in charge of
everybody tell us why the other folks are doing it right.
Dr. Clancy. If I might, Dr. Alaigh is a woman.
Mr. Poliquin. Wonderful. Thank you very much. I appreciate
it. Thank you, Mr. Chairman. I yield back my time.
Mr. Bergman. Thank you. Thanks to everyone. Thanks to the
witnesses. This has been a great next first step as we move
forward with a very serious issue here. You are now excused.
It is clear from the testimony that has been provided
today, as well as the numerous cases we here about in the news
that drug diversion is a major problem at VA facilities. The
lack of oversight over VA's controlled substances and the
apparent lack of accountability for failing to monitor proper
distribution, storage and destruction is troubling. We hope
that by bringing this issue to light, it will encourage the VA
to take steps necessary to impose better oversight and control.
I look forward to hearing back on the progress and changes
the VA is making. 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.
I would like to, once again, thank all our witnesses and
the audience members for joining in today's conversation. With
that, this hearing is adjourned.
[Whereupon, at 4:44 p.m., the Subcommittee was adjourned.]
A P P E N D I X
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Prepared Statement of Carolyn Clancy, M.D.
Good morning, Chairman Bergman, Ranking Member Kuster, and Members
of the Subcommittee. Thank you for the opportunity to discuss oversight
of controlled substances and Drug Free Workplace programs at Department
of Veterans Affairs (VA) facilities. I am accompanied today by Michael
A. Valentino, Chief Consultant for the Veterans Health Administration's
(VHA) Pharmacy Benefits Management Service (PBM).
Introduction
VHA is the Nation's largest integrated health care system, and
pharmacy services are a vital part of delivering the high-quality
health care our Veterans deserve. Our pharmacy program is widely
regarded as the professional benchmark for clinical pharmacy practice,
drug formulary management, prescription fulfillment services, and
1A\1\medication 1A\2\safety. \3\
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\1\ Gellad, W.F., Good, C.B., & Shulkin D.: Addressing the opioid
epidemic: Lessons from the Veterans Affairs. JAMA Int. Med. (in press).
\2\ Aspinall, S.L., Sales, M.M., Good, C.B., Canzolino, J.J.,
Calabrese, V., Glassman, P.A., Burk, M., Moore, V., Neuhauser, M.M.,
Golterman, L., Ourth, H., Morreale, A., Valentino, M., & Cunningham,
F.E. Pharmacy benefits management in the Veterans Health Administration
revisited: 2004-2014- A decade of advancements. J. Manag. Care. Pharm.
2016; 22(9):1058-1063.
\3\ United States Senate Committee on Veterans' Affairs, Hearing on
Overmedication: Problems and Solutions. Apr. 30, 2014. 113th Cong. 2nd
sess. Washington: GPO, 2015 (statement of Mark Edlund, Health Services
Researcher, RTI International).
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VHA's PBM is responsible for providing a broad range of pharmacy
services via 260 VA medical center and community-based outpatient
clinic pharmacies and 7 Consolidated Mail Outpatient Pharmacies (CMOP).
In fiscal year (FY) 2016, VHA dispensed more than 147 million
prescriptions to over 5 million unique Veterans. Of these, 30 million
were provided by medical facility pharmacies, and 117 million by CMOPs.
Oversight of controlled substances is multi-faceted and involves:
1) ensuring VA lists controlled substances on its National Formulary
that have evidence of safety and effectiveness; 2) providing evidence-
based prescribing criteria for controlled substances; 3) developing
internal controls for physical drug security; 4) using electronic
prescribing to prevent forgery; 5) monitoring suspected cases of theft
or diversion and taking appropriate follow-up action; 6) addressing any
controlled substances prescribing that does not align with evidence-
based criteria; 7) implementing patient-focused initiatives such as
medication take-back programs; 8) overdose education and naloxone
distribution; and 9) ensuring the availability of complementary and
integrative medicine therapies in place of controlled substances.
As part of its long-standing focus on medication safety, VHA
implemented robust controlled substance security measures in the early
1980s. In many cases, these security measures far exceed the
requirements of the Controlled Substances Act (CSA). For example, CSA
requires that an actual count of scheduled II controlled substances and
an estimated count of most of Schedule III through V controlled
substances be performed every two years. However, VA performs an actual
count of all Schedules of controlled substances every 72 hours. In
addition CSA allows Schedule III through V controlled substances to be
dispersed among non-controlled substances in the pharmacy. However, VA
requires all Schedules of controlled substances to be stored under lock
and key, with electronic access controls requiring two-factor
authentication.
Individuals who are determined to divert controlled substances may
find a way to do so despite the existence of robust controls. This is
true within and outside of VA. Data from January 2, 2014, through March
11, 2016, show that VA had 2,405 reports of internal and external
losses, some of which were due to diversion. The data also show that
approximately 92 percent of controlled substances losses occur in the
mailing system during shipping to the Veteran, 1.5 percent of losses
are due to diversion by VA staff, 1.2 percent are due to external theft
outside of the mailing system, 0.3 percent are due to dispensing errors
and 5.6 percent are unknown but likely due to manufacturer shortages in
stock bottles, miscounts, or similar issues.
During this same time period, VA dispensed approximately 29 million
prescriptions for controlled substances, as well as a very large number
of individual doses of controlled substances for hospitalized patients.
Using only the number of controlled substance prescriptions, which
overestimates reports of loss by not including inpatient doses, the
2,405 reports filed indicate a controlled substance loss rate of 0.008
percent.
Opioid Safety Initiative (OSI)
The OSI was chartered by the Under Secretary for Health in August
2012 and piloted in several Veterans Integrated Service Networks
(VISN). Based on the results of these pilot programs, OSI was
implemented nationwide in August 2013. The OSI objective is to make the
totality of opioid use visible at all levels in the organization. This
includes key clinical indicators such as the number of unique pharmacy
patients dispensed an opioid, unique patients on long-term opioids who
receive a urine drug screen, patients receiving an opioid and a
benzodiazepine (which puts them at a higher risk of adverse events), as
well as the average morphine equivalent daily dose (MEDD) of opioids.
OSI has demonstrated achievement by multiple metrics, including by:
a reduction in the number of patients receiving opiate analgesics; 2) a
reduction in the number of patients receiving them for longer than 90
days; 3) a reduction in the concurrent prescription of opiate
analgesics with other controlled substances that have potential for
drug interactions; 4) a reduction in their average daily dose; and 5)
an increase in the number of patients who are receiving opiate
analgesics with completed drug screens.
Results of key clinical metrics for the OSI from the fourth quarter
4 of FY 2012 (beginning in July 2012) to the first quarter of FY 2017
(ending in December 2016) are:
208,036 fewer patients receiving opioids (679,376
patients to 471,340 patients, a 31 percent reduction);
69,148 fewer patients receiving opioids and
benzodiazepines together (122,633 to 53,485 patients, a 56 percent
reduction);
157,300 fewer patients on long-term opioid therapy
(438,329 to 281,029, a 36 percent reduction).
The percentage of patients on long-term opioid therapy
who have had a urine drug screen to help guide treatment decisions has
increased from 37 percent to 86 percent (a 49 percent increase)
The overall dosage of opioids is decreasing in the VA
system as 26,350 fewer patients (59,499 to 33,149, a 44 percent
reduction) are receiving greater than or equal to a 100 MEDD.
Additionally, the desired results of OSI have been achieved despite
an overall growth of 119,766 patients who are receiving prescriptions
from VA at the same time. While these changes may appear to be modest,
given the size of the VA patient population, they signal an important
trend in VA's use of opioids. VA expects this trend to continue as it
renews its efforts to promote safe and effective pharmacologic and non-
pharmacologic pain management therapies.
GAO Report
The Government Accountability Office (GAO) provided VHA a draft
report on December 16, 2016, titled VA HEALTH CARE: Actions Needed to
Ensure Medical Facility Controlled Substance Inspection Programs Meet
Agency Requirements. In the report, GAO found that diversion of opioid
pain relievers and other controlled substances by health care providers
has occurred at several VA medical facilities. VA concurred with GAO's
six recommendations from this report:
1.The Under Secretary for Health should ensure that VA medical
facilities have established an additional control procedure, such as an
alternate controlled substance coordinator or a pool of extra
inspectors, to help coordinators meet their responsibilities and
prevent missed inspections.
2.The Under Secretary for Health should ensure that VA medical
facilities have established a process where coordinators, in
conjunction with appropriate stakeholders (e.g., pharmacy officials),
periodically compare facility inspection procedures to VHA's policy
requirements and modify facility inspection procedures as appropriate.
3.The Under Secretary for Health should improve the training of VA
medical facility controlled substance coordinators by ensuring the
training includes the inspection procedures that VHA requires.
4.The Under Secretary for Health should ensure that medical
facility directors have designed and implemented a process to address
nonadherence with program requirements, including documenting the
nonadherence and the corrective actions taken to remediate nonadherence
or the actions that demonstrate why no remediation is necessary.
5.The Under Secretary for Health should ensure that networks review
their facilities' quarterly trend reports and assure facilities take
corrective actions when nonadherence is identified.
6.The Under Secretary for Health should ensure that networks
monitor their medical facilities' efforts to establish and implement a
review process to periodically compare facility inspection procedures
to VHA's policy requirements.
The final GAO report was published on February 15, 2017, and VA is
in the process of implementing the recommendations:
1.VHA's Directive 1108.02, Inspection of Controlled Substances,
provides guidance to Facility Directors to ensure the Controlled
Substances Programs develop and remain compliant with the requirements.
The PBM will develop a memorandum that outlines the expectations of
Directive 1108.02 and specifically the requirements to: 1) have
mandatory training; 2) appoint an alternate Controlled Substance
Coordinator; and if one is not already appointed, to provide back-up
support; and 3) adding inspectors to the program to ensure inspections
are not missed. Each Facility Director will then be provided this
memorandum, and Facility Quality Managers (QM) will report compliance
to the VISN QM Officer.
2.Each Medical Facility Director will be required to compare the
current inspection program policy and procedures with VHA Directive
1108.02 using the Self-Assessment guide. The self-assessment will be
completed by a multidisciplinary group including the Controlled
Substance Coordinator, Chief of Pharmacy or designee, Nurse Executive
or designee, and Facility QM or designee. The results of the self-
assessment will be reviewed by the facility QM Committee. An action
plan must be developed for identified deficiencies and progress tracked
until completion through the QM committee.
3.The Deputy Under Secretary for Health for Operations and
Management (DUSHOM) will provide the memorandum developed in response
to Recommendation 1 that outlines the requirements that all current and
future Controlled Substance Coordinators complete the Talent Management
System web-based Controlled Substance Inspector Certification training
program in addition to the Controlled Substance Coordinator Orientation
Training Course. The certification course contains detailed information
on conducting inspections. VHA Directive 1108.02, Inspection of
Controlled Substances, will be updated with this requirement.
4.PBM will develop guidance to be distributed by the DUSHOM
directing Medical Facility Directors to assess adherence with program
requirements at least quarterly. The facility QM Committee will review
and evaluate monthly and quarterly reports for adherence with
requirements and corrective actions taken or required to ensure
compliance with program requirements in VHA Directive 1108.02. All
corrective actions will be documented and followed through to
completion by the QM Committee and reported to the Medical Facility
Director.
5.PBM will develop a memorandum that outlines the expectations of
Directive 1108.02 and specifically the requirements that Networks will:
1) review their facilities' quarterly trend reports and ensure
facilities take corrective actions when nonadherence is identified, and
2) monitor their medical facilities' efforts to establish and implement
a review process to periodically compare facility inspection procedures
to VHA's policy requirements. The DUSHOM will provide this memorandum
to each Network Director, who will disseminate it to the Facility
Directors, thereby ensuring appropriate actions have been taken to
ensure the actions listed in the memorandum are completed.
At completion of each of these actions, the VISN QM Officer will
monitor compliance and provide an action plan for any non-compliant
facilities within that VISN to PBM and the DUSHOM. The two offices will
meet and decide whether any further actions are needed. The status of
each response is in process, and the target completion date is October
2017.
VA's Drug Free Workplace Program
VA, as an employer, understands that well-being of its employees is
essential to the successful accomplishment of the agency's mission, and
is dedicated to maintaining high employee productivity. As such we are
committed to implementing Executive Order (EO) 12564, signed by
President Ronald Reagan on September 15, 1986, requiring all Federal
agencies to develop a plan to combat drugs in the workplace.
VA takes very seriously our mission to provide top quality care and
services to our Veterans. In doing so, our human resources offices play
a very vital role in implementing our Drug Free Workplace Program
(DFWP). As the second largest employer in the Federal Government, VA
can and should continue to show the way towards achieving drug-free
workplaces through programs designed to offer drug users a helping hand
and, at the same time demonstrating that drugs will not be tolerated in
the workplace. The use of illegal drugs by VA employees is inconsistent
with the special trust placed in such employees who care for Veterans.
VA has recently made great strides towards improving the Drug Free
Workplace Program.
Beginning in October 2015, Drug Program Coordinators began
certifying on a monthly basis that employees selected for random drug
testing were tested, when they were tested, or why they were not
tested. In November 2015, the Office of Human Resource Management began
reviewing the data entered in the notification site for compliance and
has continued in the ensuing months to conduct this review. Those
Coordinators not in compliance with the certification process are
reported to their chain of command until compliance is achieved.
VA is developing procedures to ensure the drug testing coding of
employees in Testing Designated Positions (TDP) is accurate and
complete. We are working with our HR Smart (VA's recently implemented
human resources information system) business partner to implement a
monthly process ensuring that all employees occupying Testing
Designated Positions identified in VA Directive 5383 are included in
the pool of random selectees each month. The update process will run
prior to the random selection of employees to be tested that month. In
addition, queries are now available to human resource (HR) offices to
assist them in ensuing all testing designated positions are
appropriately coded.
VA is committed to 100 percent testing of all final selectees for
Testing Designated Positions prior to appointment. On March 1, 2016,
the Assistant Secretary for Human Resources and Administration
published a memorandum stating that 100 percent of all applicants
tentatively selected for appointment to a TDP be drug tested prior to
appointment.
VA has implemented a process to monitor local compliance with VA's
DFWP requirements. Beginning in March 2016, the DFWP website was
modified to reflect that Coordinators were to certify that all
applicants selected for all TDPs were tested in accordance with VA
Handbook 5383. Those Coordinators not in compliance with the
certification process are reported to their chain of command until
compliance is achieved.
OIG Review of Drug Testing at Atlanta VA Medical Center
In April 2015, the VA Office of Inspector General (OIG) opened an
investigation at the Atlanta VA Medical Center (VAMC) to review
allegations of a backlog of over 300 unadjudicated background
investigations and that mandatory drug testing of new hires did not
occur over a 6-month period. It is important to note that this
inspection happened before many of the institutional changes described
above were implemented.
The investigation substantiated both allegations and found that, as
of July 2015, the Atlanta VAMC had a backlog of about 200 unadjudicated
background investigations; Atlanta VAMC human resources personnel
acknowledged a backlog dating as far back as 2012. It was also found
that the DFWP was not administered from November 2014 to May 2015.
VA appreciates OIG's work in making recommendations to improve our
hiring processes. Atlanta VAMC leadership implemented a number of
changes in 2016 including:
realigning the human resources department under the
direct supervision of the Medical Center Director;
hiring a new human resources officer;
dedicating a senior staff member to the personnel
security section to oversee personnel assigned to that function; and
developing a secondary database to work in tandem with
the current system for staffing and tracking all background
investigations, expiration, status, open and closed dates.
Atlanta VAMC identified 220 employees who require drug testing, and
began notifications to these employees in December 2016. A phased
approach is necessary to take into account workload, the number of
people tested, and staffing levels. The Atlanta VAMC expects to
complete testing by March 2017.
Conclusion
Mr. Chairman, I am proud of the health care our facilities provide
to our Veterans, including prescription drug services. With support
from Congress, we look forward to continuing to improve our oversight
of controlled substances and drug free workplace programs, which will
further improve the care our Veterans deserve. Thank you for the
opportunity to testify before this subcommittee. I look forward to your
questions.
Prepared Statement of Nicholas Dahl
Mr. Chairman, Ranking Member Kuster, and Members of the
Subcommittee, thank you for the opportunity to testify today on the
Office of Inspector General's (OIG) work related to oversight of
controlled substances and drug free workplace programs at VA
facilities. I am accompanied by Emorfia Valkanos, a member of the OIG's
Office of Healthcare Inspections staff in Manchester, New Hampshire,
who is also a pharmacist.
BACKGROUND
The Federal Drug-Free Workplace Program was initiated by Executive
Order 12564 in 1986. The Executive Order established the goal of a
drug-free Federal workplace and made it a condition of employment for
all Federal employees to refrain from using illegal drugs on or off
duty. The following year, Congress passed legislation (P.L. 100-71,
Supplemental Appropriations 1987) designed to establish uniformity
among Federal agencies' drug testing, confidentiality of drug test
results, and centralized oversight of the drug testing program.
Within VA, the Deputy Assistant Secretary for Human Resources
Management is responsible for the implementation of the Department's
Drug-Free Workplace Program. Drug Program Coordinators at each Veterans
Health Administration (VHA) facility are responsible for scheduling
drug tests each month for randomly selected employees. Department-wide,
VA randomly selects 285 employees each month across its facilities for
drug testing-for an annual total of 3,420 employees.
VA Directive and Handbook 5383, VA Drug-Free Workplace Program,
establishes policies and procedures for VA's Drug-Free Workplace
Program. The Handbook designates safety-sensitive occupational series
as Testing Designated Positions (TDPs), such as physicians, nurses,
police officers, motor vehicle operators, and Senior Executive Service
employees.
There are several components to VA's Drug-Free Workplace Program,
including:
Pre-employment applicant testing of final selectees for
TDPs.
Random monthly drug testing of employees in TDPs. (Human
Resources officials are responsible for properly coding employees in
TDPs with the drug test code in VA's personnel information system.)
Drug testing of employees when there is reasonable
suspicion of on-the-job drug use or where drug use is suspected
following a workplace accident or injury.
VA also requires that managers at VHA facilities ensure that a
controlled substance inspection program is implemented and maintained.
VHA Handbook 1108.02, Inspection of Controlled Substances, details
requirements for facility controlled substances inspections.
OIG WORK
In recent years, the OIG has conducted an audit and a review where
we assessed aspects of the Drug-Free Workplace Program. The audit
included a comprehensive assessment of the effectiveness of VA's Drug-
Free Workplace Program. We identified program weaknesses and made
recommendations to improve the effectiveness of the program. The review
revealed one medical center did not conduct drug testing for a 6 month
period. The review also revealed a lack of oversight of the Drug-Free
Workplace Program, both at a local and national level, in that the 6
month lapse in testing was not timely identified.
Drug-Free Workplace Program
In March 2015, we reported VA needed to improve the management of
its Drug-Free Workplace Program to ensure the program was effective in
maintaining a workplace that is free from illegal drug use. \1\ We
identified program weaknesses and determined VA's Program was not
accomplishing its primary goal of ensuring illegal drug use was
eliminated and VA's workplace was safe.
---------------------------------------------------------------------------
\1\ Audit of VA's Drug-Free Workplace Program, March 30, 2015.
---------------------------------------------------------------------------
Pre-Employment Applicant Drug Test
We reported that VA's Office of Human Resources Management (OHRM)
did not ensure facility Human Resource Management Officers complied
with VA's policy to drug test all applicants selected for a TDP prior
to appointment. Instead, VA selected about 3 of every 10 applicants
selected for a TDP for pre-employment drug testing. If a tested
applicant has a verified positive test result, VA should decline
extending a final offer of employment. While VA's Drug-Free Workplace
Program Handbook states every individual tentatively selected for
employment in a TDP is subject to a drug test before appointment, OHRM
officials interpreted this language as meaning only some finalists for
TDPs needed to be drug tested before being appointed. Because of this
interpretation, we estimated approximately 15,800 (70 percent) of the
nearly 22,600 individuals VA reported appointing into TDPs during
fiscal year (FY) 2013 were not drug tested before being hired.
Employee Random Drug Testing
We estimated VA achieved a national employee random drug testing
rate of 68 percent of the 3,420 employees selected for random drug
testing in FY 2013. Of 22 randomly selected facilities, we found 4 did
not test any randomly selected employees, 10 had compliance rates
ranging from 31 to 89 percent, and 8 tested at least 90 percent of
their randomly selected employees. Facility Coordinators could not
explain why the majority of the 32 percent of employees were not
tested.
We also estimated at least 19,100 (9 percent) of about 206,000
employees in TDPs were not subject to the possibility of random drug
testing because they were not coded with a Drug Test code, as required,
in VA's personnel information system. Those not subjected to random
drug testing included physicians, nurses, and addiction therapists. In
addition, VA may have incorrectly identified as many as 13,200
employees with the Drug Test code-meaning, employees in positions that
do not usually require random drug testing were subject to testing. We
found VA did test non-DTP employees, which reduced the probability that
employees in high-risk, safety sensitive TDPs were selected for drug
testing.
Reasonable Suspicion Drug Testing
OHRM lacked sufficient oversight practices to monitor whether
facilities referred all employees with a positive drug test result to
the Employee Assistance Program (EAP). VA's Drug-Free Workplace Program
Handbook requires facilities to refer all employees with a positive
drug test result to its EAP for assessment, counseling, and referral
for treatment or rehabilitation. However, facility Coordinators
reported that only 17 of 51 employees who tested positive for drugs as
a result of reasonable suspicion or after a workplace accident or
injury were referred to their facility's EAP.
We made five recommendations to the Deputy Assistant Secretary for
Human Resources Management. These recommendations included:
Ensuring all final selectees for TDPs complete pre-
employment drug testing prior to appointment
Increasing accountability to ensure all employees
selected for random drug testing are tested
Improving the accuracy of Drug Test coding in VA's
personnel information system
Implementing procedures to ensure Custody and Control
forms are accurately completed
Ensuring compliance with Program requirements, such as
referring employees who test positive to the EAP.
The then Acting Deputy Assistant Secretary concurred with our
recommendations and provided action plans that were responsive to our
recommendations. This included a plan to require mandatory pre-
employment drug testing of all candidates selected for a TDP. Action in
response to four of the five recommendations has been completed. VA
continues to work on actions to ensure the accuracy of Drug Test coding
in its personnel information system. Recently, VA notified us that they
continue to work with their personnel information system business
partner to implement this recommendation. We will continue to track
their progress until we receive documentation that action is complete.
Human Resources Delays
In January 2017, we reported on delays in the processing of certain
human resources functions at the Atlanta VA Medical Center (VAMC). \2\
We conducted our work to assess allegations that there was a backlog of
unadjudicated background investigations \3\ and mandatory drug testing
for new hires in TDPs \4\ did not occur for a period of at least 6
months between 2014 and 2015. We substantiated both allegations.
Regarding the allegation that the Atlanta VAMC did not administer the
Drug-Free Workplace Program for 6 months, we found no drug testing was
completed at the VAMC from November 2014 through May 2015. This lapse
occurred because the facility Coordinator left the position in
September 2014 and the alternate Coordinator did not assume the
collateral duties required of this position. Further, other VAMC Human
Resources personnel were unaware of the Drug-Free Workplace Program
responsibilities. Despite the lack of drug testing for 6 months, we
found no indications VA management was aware of the lapse. Because no
drug testing occurred, the Atlanta VAMC lacked assurance that employees
who should have been subject to drug testing remained suitable for
employment. We made five recommendations in the report:
---------------------------------------------------------------------------
\2\ Review of Alleged Human Resources Delays at the Atlanta VAMC,
January 30, 2017.
\3\ An adjudication is considered backlogged after 90 days without
a determination.
\4\ There was also no monthly random drug tests for current
employees in TDPs.
Develop an action plan to ensure staff have appropriate
background investigations and determinations are accurately recorded
Ensure all suitability adjudicators receive the mandatory
training and background investigation required for the position
Provide training to all human resources staff on the
requirements of the personnel suitability program
Ensure human resources staff are trained on the
requirements of the Drug-Free Workplace Program and the
responsibilities of their positions
Review the Drug-Free Workplace Program on a regular basis
to ensure compliance with regulations and that employees hired during
gaps are subject to corrective testing.
The Atlanta VAMC Director concurred with our recommendations and
reported that action has been taken with regards to the Drug-Free
Workplace Program. When we receive documentation of action related to
those recommendations, we anticipate closing them.
Evaluation of the Controlled Substances Inspection Program
During our past inspections of VHA medical centers through our
Combined Assessment Program reviews (CAP Reviews), we analyzed pharmacy
operations including environment of care, management of controlled
substances, and pharmacy security. In 2008, we reported facility
managers needed to reinforce compliance with VHA policy regarding
controlled substances inspections. We conducted another review during
our fiscal year 2013 CAP Reviews to include 58 facilities and issued a
summary of the results in June 2014. \5\ The summary report contained
10 recommendations focused on opportunities for improvements:
---------------------------------------------------------------------------
\5\ Combined Assessment Program Summary Report - Evaluation of the
Controlled Substances Inspection Program at Veterans Health
Administration Facilities, June 10, 2014.
Conducting annual physical security surveys and
correcting identified deficiencies
Completing controlled substances quarterly trend reports
and providing them to facility Directors
Conducting monthly controlled substances inspections of
non-pharmacy areas
Completing non-pharmacy controlled substances inspection
activities
Performing emergency drug cache quarterly controlled
substances physical counts and monthly verification of seals
Validating completion of required drug destruction
activities
Verifying 10 percent of outpatient pharmacy written
prescriptions for Schedule II drugs
Validating accountability of prescription pads stored in
the pharmacy
Defining policy for acceptable reasons for missed
controlled substances area inspections
Providing annual controlled substances inspectors
training.
VA concurred with the recommendations and reported in December 2014
that action had been taken to address these recommendations.
Investigative Work
The OIG conducts criminal investigations regarding drug diversion
classified in three categories.
Diversion of Controlled and Non-controlled Substances by VHA Employees
Diversion by healthcare providers is a serious issue that OIG
diligently pursues. Not only is it an issue of theft, it is potentially
an issue of patient safety if the provider is ingesting controlled
substances while on duty, if false entries are placed in patient files
to cover up the diversion, or if patients are given another substance
in place of the diverted drug. OIG recently concluded an investigation
of drug diversion that resulted in a former Albany, New York, VAMC
hospice nurse being sentenced to 82 months' incarceration and 3 years'
supervised release after pleading guilty to tampering with a consumer
product and obtaining controlled substances by deception and
subterfuge. The investigation by the OIG and the Food and Drug
Administration, Office of Criminal Investigation, revealed the
defendant stole oxycodone hydrochloride from syringes and replaced the
contents with Haldol, an anti-psychotic medication. The investigation
further revealed the defendant may have inflicted pain and suffering on
dying hospice patients by diverting their pain medications for his own
use and replacing it with a drug that was subsequently administered by
other nurses.
Diversion of Controlled and Non-controlled Substances for Illegal
Distribution
VA pharmaceuticals are also diverted or stolen for the purpose of
illegal sale. An ongoing investigation at the Little Rock, Arkansas,
VAMC has led to two pharmacy technicians and a pharmacy technician
student trainee being indicted for charges to include conspiracy,
theft, and possession with intent to distribute. The OIG investigation
resulted in the defendants being charged with diverting and
distributing 4,000 oxycodone tablets, 3,300 hydrocodone tablets, 308
oz. of promethazine with codeine syrup, and over 14,000 Viagra and
Cialis tablets. Three additional VA employees were identified as part
of the drug diversion, resulting in a resignation and reassignments.
The monetary loss to VA is over $77,000.
Diversion of Controlled Substances via Theft of Mailed Pharmaceuticals
Mailed pharmaceuticals are vulnerable to theft at any point in the
process. The most common occurrence is theft by employees of the mail
carrier, either Government or private. This type of diversion results
in veterans experiencing delays in receiving their medication. A recent
VA OIG and UPS Security investigation revealed a defendant stole
several VA packages containing oxycodone and morphine that were
intended for veterans residing in Memphis, Tennessee. During the
investigation, the defendant was caught attempting to steal an
additional package and confessed to the thefts. The (now) former UPS
driver was sentenced to time served and 3 years' probation after
pleading guilty to theft.
CONCLUSION
The OIG has provided cross cutting oversight of the Drug-Free
Workplace Program through our audits, inspections, and investigations.
This oversight is necessary to ensure that VA takes the necessary steps
to reduce risks to the safety and well-being of veterans and VA
employees by having and following the proper program controls. We also
have an active program investigating and having those engaged in drug
diversion prosecuted. Without appropriate actions, we concluded VA
lacked reasonable assurance that it is achieving a drug-free workplace
and adequately securing controlled substances.
Mr. Chairman, this concludes our statement. We would be happy to
answer any questions that you or other Subcommittee Members may have.
Prepared Statement of Randall B. Williamson
Actions Needed to Ensure Medical Facilities' Controlled Substance
Programs Meet Requirements
Chairman Bergman, Ranking Member Kuster, and Members of the
Subcommittee:
I am pleased to be here today to discuss our recent report on the
controlled substance inspection programs at medical facilities run by
the Department of Veterans Affairs (VA). \1\ The Veterans Health
Administration (VHA), which operates VA's health care system, requires
that each of its medical facilities with stocks of controlled
substances implement an inspection program to help reduce the risk of
employees diverting for their own personal use controlled substances
intended for veterans. Diversion of controlled substances such as
opioid pain relievers can occur anywhere in a facility where employees
have access to controlled substances, and this diversion can pose a
risk to veterans-for example, by depriving them of needed medications.
Without effective practices to reduce the risk of diversion by
employees and to quickly identify it, diversion can remain undetected.
---------------------------------------------------------------------------
\1\ GAO, VA Health Care: Actions Needed to Ensure Medical Facility
Controlled Substance Inspection Programs Meet Agency Requirements, GAO
17 242 (Washington, D.C.: Feb.15, 2017).
---------------------------------------------------------------------------
Under its controlled substance inspection program, VHA requires
medical facilities to conduct monthly inspections following specified
procedures outlined in VHA's inspection program policy. These
inspections must be performed in all facility areas that are authorized
to have controlled substances-including pharmacies and patient care
areas such as operating and emergency rooms. \2\ At each medical
facility, the facility's director is primarily responsible for
overseeing the inspection program and ensuring that the facility's
program adheres to VHA's requirements. The facility director must
appoint a coordinator to manage the controlled substance inspection
program and the inspectors who conduct the inspections. The coordinator
is responsible for ensuring that the inspections are conducted each
month and submitting reports summarizing the results from the monthly
inspections and trends to the facility director. The Veterans
Integrated Service Network (network) that oversees the facility is
responsible for reviewing the inspection program trend reports
annually.
---------------------------------------------------------------------------
\2\ As described in our report, we reviewed VHA's controlled
substance inspection program policy issued in 2010, which was the most
current policy at the time our review. See Department of Veterans
Affairs, Veterans Health Administration Handbook 1108.02, Inspection of
Controlled Substances (Washington, D.C., Mar. 31, 2010). VHA issued an
update to its policy in November 2016. See Department of Veterans
Affairs, Veterans Health Administration Directive1108.02, Inspection of
Controlled Substances (Washington, D.C., Nov. 28, 2016).
---------------------------------------------------------------------------
My testimony today summarizes the findings from our report
analyzing the implementation and oversight of controlled substance
inspection programs at select VA medical facilities. Accordingly, this
testimony addresses:
1.the extent to which selected VA medical facilities have
implemented controlled substance inspection programs as required by VHA
policies, and
2.VHA's oversight of these programs at selected VA medical
facilities.
In our report, we recommend several key actions that VA should take
to ensure that the facilities' inspection programs meet VHA's
requirements, and my testimony summarizes these recommendations and
VA's response to them.
To conduct our work, we reviewed VHA policies and interviewed
officials from 1) VHA Central Office, 2) a nongeneralizable selection
of four VA medical facilities, and 3) the four networks that oversee
these facilities. We selected the four facilities to achieve variation
in geography and in the number of prescriptions for opioid pain
relievers dispensed in the states in which the facilities operate. The
four VA medical facilities we selected are located in Washington, D.C.;
Milwaukee, Wisconsin; Memphis, Tennessee; and Seattle, Washington. We
compared the number of controlled substance inspections that officials
from each of the four VA medical facilities reported to us as having
been completed from January 2015 through February 2016 to the number of
inspections that should have been conducted, based on VHA's policy
requirements. We reviewed the inspection procedures in place at each of
the four facilities as described in the facilities' inspection program
policies and other guidance documents, and we compared these procedures
to VHA's policy requirements. We also reviewed the monthly and
quarterly inspection reports for each of the four selected facilities
during our review period and analyzed the contents of VHA's online
training courses for coordinators and inspectors. We compared the
implementation and oversight of the facilities' controlled substance
inspection programs to VHA's policy requirements and to federal
standards for internal control related to control activities,
monitoring, and oversight. \3\ Further details on our scope and
methodology are included in our report. \4\ The work this statement is
based on was performed in accordance with generally accepted government
auditing standards.
---------------------------------------------------------------------------
\3\ GAO, Standards for Internal Control in the Federal Government,
GAO 14 704G (Washington, D.C.: Sept. 10, 2014). GAO, Standards for
Internal Control in the Federal Government, GAO/AIMD-00-21.3.1
(Washington, D.C.: Nov. 1, 1999). Internal control is a process
effected by an entity's management, oversight body, and other personnel
that provides reasonable assurance that the objectives of an entity
will be achieved.
\4\ See GAO 17 242.
Selected VA Medical Facilities Did Not Conduct All Monthly Inspections
---------------------------------------------------------------------------
or Follow All Required VHA Inspection Procedures
We found that from January 2015 through February 2016, one of the
four selected facilities we reviewed missed 43 percent of the required
monthly inspections, and another facility missed 17 percent of these
inspections. Further, at both facilities, most of the missed
inspections were for patient care areas such as the operating rooms.
\5\ At one of the two facilities, inspectors had missed all 14
inspections of the facility's operating rooms during our 14-month
review period. The facility's coordinator told us that the operating
rooms were not inspected during this time because the assigned
inspectors needed to arrive before or after normal operating room hours
to obtain access to the controlled substances and were unable to
conduct the inspections due to their conflicting work schedules. \6\ As
a result of missed inspections in the operating rooms and other patient
care areas, these medical facilities lack reasonable assurance that
their physical inventory of controlled substances matches the recorded
inventory, thereby increasing the risk that controlled substances could
be stolen. Further, their ability to protect veterans from the harm
that can result from diversion, such as depriving them of needed pain
medications, is limited. The other two VA medical facilities we
reviewed fully adhered to VHA's requirement to conduct monthly
inspections in their patient care areas and pharmacies.
---------------------------------------------------------------------------
\5\ VHA's inspection program policy requires that facilities
inspect patient care areas and pharmacies on a monthly basis using
specific procedures.
\6\ A team of inspectors is assigned from various areas of the
medical facility.
---------------------------------------------------------------------------
We also found that three of the four selected VA medical
facilities, when conducting inspections, did not include, or correctly
follow, three or more of the nine VHA inspection requirements we
reviewed. The fourth facility we reviewed had implemented inspection
procedures that followed these nine requirements. For example,
inspectors at two facilities did not verify that controlled substances
had been properly transferred from their facility pharmacies to the
automated dispensing machines in patient care areas. \7\ VHA requires
inspectors to verify that all controlled substances transferred by a
pharmacy on a selected day were received in patient care areas such as
the operating room. However, at one facility, inspectors told us that
they did not conduct this required procedure in one of the facility's
two pharmacies. At another facility, inspectors verified only a sample
of controlled substances dispensed by the pharmacy to confirm that the
substances were actually transferred. Without checking that all
controlled substances were properly transferred, inspectors may not
identify controlled substances that are dispensed by the pharmacy and
subsequently diverted rather than stocked in the automated dispensing
machines located in patient care areas. \8\
---------------------------------------------------------------------------
\7\ Automated dispensing machines are computerized drug storage and
dispensing medication cabinets.
\8\ The VA Office of the Inspector General also found in 2009-and
again in 2014-that VA medical facilities did not always conduct
required inspections or follow VHA's required procedures. For example,
see VA Office of the Inspector General, Combined Assessment Program
Summary Report: Evaluation of the Controlled Substances Inspection
Program at Veterans Health Administration Facilities (Washington, D.C.:
June 10, 2014).
---------------------------------------------------------------------------
We found that several factors contributed to the missed inspections
and incorrect implementation of inspection procedures that we
identified.
First, the two VA medical facilities that missed inspections lacked
an additional control procedure, such as designating an alternate
coordinator or appointing additional inspectors, to help prevent missed
inspections when the assigned inspectors could not conduct them. Both
of the facilities that conducted all of the required monthly
inspections had an alternate coordinator to assist the coordinator in
managing the inspection program, including scheduling the inspections
and following up with inspectors to ensure inspections are completed.
In addition, the alternate coordinator at one of these facilities
conducted inspections when inspectors had unforeseen circumstances that
prevented them from completing the assigned inspections. In contrast,
the two medical facilities that missed inspections did not have an
additional control procedure, such as the use of an alternate
coordinator. Without coordinators ensuring that the monthly inspections
are conducted, VA medical facilities lack assurance that the inspection
programs are meeting the objective to reduce the risk of diversion of
controlled substances.
Second, three of the four VA medical facilities in our review did
not have written inspection procedures that were fully consistent with
VHA's policy requirements. This likely contributed to their inspections
not following certain VHA policy requirements. (See figure 1.)
[GRAPHIC] [TIFF OMITTED] T9370.001
Note: At the four selected Department of Veterans Affairs (VA)
medical facilities, we reviewed written inspection procedures that were
included in the local inspection program policies, training manuals and
other guidance documents and compared them to the Veterans Health
Administration's (VHA) inspection program requirements included in
VHA's 2010 policy. See Department of Veterans Affairs, Veterans Health
Administration Handbook 1108.02, Inspection of Controlled Substances
(Washington, D.C.: Mar. 31, 2010).
aVA medical facility C had no written procedures for its pharmacy
inspections. Although this VA medical facility's inspection program
policy stated that inspections must follow the required procedures
included in VHA's Handbook 1108.02, this handbook was not included in
the guidance that inspectors told us they used in performing and
implementing the inspection procedures.
The one VA medical facility that had written inspection procedures
that were consistent with VHA's policy requirements has an ongoing
process to conduct comprehensive reviews of its procedures. At this
facility, the coordinators had conducted separate reviews of the
facility's procedures in coordination with two pharmacy managers,
according to a facility official. In contrast, at the other three
selected VA medical facilities, the coordinators' reviews of the
facilities' procedures were not as comprehensive. For example, the
coordinator at one facility told us he had compared the facility's
procedures to the VHA requirements but did not involve other facility
officials to verify the accuracy of his review.
Third, while VHA relies on coordinators to ensure that the
inspections are conducted correctly, we found that VHA's training
course for coordinators lacks substantive information about VHA's
required inspection procedures. VHA's training course for inspectors,
in comparison, includes substantive information about the required
inspection procedures. While two of the four coordinators we
interviewed told us they were provided helpful on-the-job training at
their medical facilities, which included shadowing the prior
coordinator, three of them told us that additional coordinator training
was needed.
In our report we noted that missed inspections and gaps in
facilities' local inspection procedures and coordinator training are
inconsistent with federal internal control standards, which state that
management should periodically review their procedures for
effectiveness and provide proper training to achieve results. We
concluded that missed inspections and gaps in inspection procedures and
training could significantly limit VHA's ability to reduce the risk of
diversion of controlled substances. To address these shortcomings, we
recommended that VA ensure that VA medical facilities establish an
additional control procedure, such as an alternate coordinator, to help
prevent missed inspections as well as a process in which coordinators
and other stakeholders compare facility inspection procedures to VHA's
policy requirements and modify facility procedures, as appropriate. We
also recommended that VA improve its coordinator training by ensuring
that the training includes the inspection procedures that VHA requires.
VA agreed with these recommendations and said it plans to take steps to
implement them by October 2017.
Oversight of Controlled Substance Inspection Programs by Selected VA
Medical Facilities and Networks Is Inconsistent
We found inconsistent oversight of the controlled substance
inspection programs at selected VA medical facilities by facility
directors and by the networks to which the facilities report. Directors
at two of the four facilities had not implemented corrective actions to
address missed inspections identified by coordinators in the monthly
inspection reports that the directors had reviewed. In addition, one of
four facility directors did not receive quarterly trend reports during
our review period as required by VHA policy and did not implement a
corrective action to ensure that he receives future reports. Further,
we found that two of the four networks did not review their facilities'
quarterly trend reports as required by VHA policy. Officials at one of
these two networks told us that they were unaware of the requirement,
while an official in the other network told us the officials
responsible for reviewing the reports did not realize it was a
requirement. \9\ One network that had reviewed the quarterly trend
reports did not follow up with a facility in our review to ensure that
the coordinator had submitted missed trend reports to the facility's
director. We also found that this coordinator had not completed other
quarterly trend reports, and the facility's director did not develop a
corrective action plan to ensure the completion of these reports in the
future.
---------------------------------------------------------------------------
\9\ VHA included this network requirement in a 2014 memo that it
issued in response to the VA Office of the Inspector General findings
on weaknesses in the inspection programs. See VA, Memorandum on
Controlled Substance Inspection Program Requirement, VA Office of
Inspector General-Combined Assessment Program Findings (Washington,
D.C.: July 9, 2014).
---------------------------------------------------------------------------
In our report, we pointed out that the inconsistent oversight by
the directors and networks is contrary to federal internal control
standards, which call for oversight to be ongoing to assess
performance, promptly remediate deficiencies, and hold individuals
accountable for their responsibilities. We concluded in our report that
without ongoing monitoring by facility directors and networks-including
holding facilities accountable for correcting nonadherence to program
requirements-VHA lacks reasonable assurance that facilities will
correct deficiencies on a timely basis. To address these oversight
problems, we recommended that VA ensure that medical facility directors
have a process in place to document and correct nonadherence with
program requirements. We also recommended that VA ensure that the
networks review their facilities' quarterly trend reports and ensure
that facilities take corrective actions when program nonadherence is
identified. VA agreed with our recommendations and said it plans to
take steps to implement them by October 2017.
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 Contacts & Staff Acknowledgments
If you or your staff members have any questions concerning this
testimony, please contact me at (202) 512-7114 ([email protected]).
Contact points for our Offices of Congressional Relations and Public
Affairs may be found on the last page of this statement. Other
individuals who made key contributions to this testimony include Marcia
A. Mann, Assistant Director; Pamela Dooley (Analyst-in-Charge); Krister
Friday; and Carmen Rivera-Lowitt.
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Prepared Statement of Keith H. Berge, M.D.
Chairman Bergman, Ranking Member Kuster, and Members of the
Committee,
Thank you for the opportunity to speak with you today about drug
diversion from the health care workplace. Such diversion is a crime
that endangers all patients, health care employers, coworkers, and even
endangers the diverters themselves. While we have long known of these
hazards of patients being deprived of pain medicine by diversion, only
fairly recently has the grave risk to extremely vulnerable patients
been revealed by outbreaks of diseases such as blood poisoning by
bacteria or viruses that have been transmitted by drug diverters
swapping syringes in the commission of their crimes. In the process,
many patients have been infected with potentially fatal illnesses. I
have attached for your review a paper authored by CDC investigators
outlining 6 such outbreaks over a 10 year period that resulted in
illness and death in patients. One of the diversion/infection scenarios
included Veteran's Affairs patients being exposed to a diverter that
communicated his Hepatitis C infection to approximately 5O patients.
This diverter was radiation technologist who traveled the country
working for multiple employment agencies. He had been fired from
multiple jobs for diverting fentanyl for his own use, but by simply
lying about previous terminations on job applications, and in the
absence of a national registry of radiation technologists, he had no
trouble finding employment. In the darkened invasive radiology suites
he would swap the fentanyl syringe on the anesthesia cart with one he
has previously used to inject himself. He would then excuse himself to
a restroom, inject himself with the stolen fentanyl, draw up tap-water,
and repeat the process with the next patient's fentanyl. In this
manner, he conveyed his potentially lethal illness to many innocent
victims. The 8 patients described in these outbreaks were all in
extremely vulnerable positions, either undergoing an invasive procedure
while under anesthesia, or in an Intensive Care Unit. Clearly, such
behavior is unacceptable, and in recognition of these dangers posed by
diversion the Drug Enforcement Administration requires stringent drug
control policies and procedures to be put in place to protect
controlled substances from attack across all points of the
manufacturing, distribution, dispensing, administration and disposal
spectrum. The drugs used in the healthcare setting are highly sought
after drugs of abuse, both by addicts and by those who would profit
richly by the sale of stolen drugs.
Experience at the Mayo Clinic and elsewhere has shown the necessity
of having robust surveillance, detection, investigation, and
intervention programs in place in order to minimize the risk to all
involved. While it will be impossible to completely eliminate drug
diversion from the healthcare workplace, it is imperative that robust
systems rapidly detect and halt such activity. I have attached for your
review an article from Mayo Clinic authors, myself included, which
outlines our program from its inception to very successful
implementation. While we continue to try to improve our system, it has
proven quite effective in identifying a host of drug diverters since
implementation 7 years ago. Diverters come from diverse backgrounds,
and include physicians, pharmacists, pharmacy techs, nurses, nursing
students, nursing assistants, janitors, patients, patient's family
members, nursing home attendants, hospice workers, and strangers off
the street. The stories are incredible, but they all point to the
powerful draw that these drugs have over addicts. As such, it is not
good enough to merely have effective policies and procedures on the
books; they must actually be rigorously followed. Diverters are
generally clever and desperate, and they will gravitate into the area
of a system where they perceive the drugs to be most vulnerable to
attack. It therefore behooves any healthcare facility to have a
reputation for being effective at rapidly identifying, terminating, and
prosecuting drug diversion and drug diverters. Only by doing so can we
protect the most vulnerable of our patients from preventable harm. As
I've stated, this problem will never go away, so we must become very
good at rapid intervention. Only by instituting and following effective
anti-diversion policies and procedures will this be possible.
I thank the Committee for its attention to this important issue,
and stand ready to answer any questions you may have.
Keith H. Berge, M.D.
Consultant, Anesthesia & Perioperative Medicine
Chair, Medication Diversion Prevention Subcommittee
Statements For The Record
AMERICAN SOCIETY OF ANESTHESIOLOGISTS
Jeffrey Plagenhoef, M.D., President, American Society of
Anesthesiologists
On behalf of more than 52,000 members, the American Society of
Anesthesiologists r (ASA) would like to thank Chairman Bergman, Ranking
Member Kuster and members of the Subcommittee for holding the hearing,
``Assessing VA's Risks for Drug Diversion,'' and providing ASA the
opportunity to submit a Statement for the Record. We greatly appreciate
your willingness to discuss this important topic and how it impacts our
nation's Veterans. Physician anesthesiologists are health care
professionals who manage and administer a large number of controlled
substances in their roles as perioperative physicians, and are pain
medicine specialists, diagnosing and treating patients with complex
pain conditions. As leaders in patient safety, anesthesiologists
thereby are uniquely positioned to address this issue. ASA believes
prevention of, and education about, drug diversion activities are
critical. We look forward to working with the Committee and others on a
multidisciplinary approach to minimize the potential for drug diversion
and ensure patients in the Department of Veteran Affairs continue to
receive high-quality care.
It is no secret that the potential for drug diversion by
clinicians, staff, patients, family members and others is a real threat
at any hospital, surgery center, nursing home, pharmacy or other care
organizations. News media and internal reviews, such as the February
2017 GAO report on controlled substance inspection programs, \1\ have
played an important role in revealing some of these instances where
health care professionals have diverted drugs for their own use, and in
some cases, the patient fatalities that have been the result. Moreover,
a report by the Substance Abuse and Mental Health Services
Administration (SAMHSA) illustrates that drug diversion contributed to
a fourfold increase in substance abuse treatment admissions between
1998 and 2008 among individuals aged 12 and older. \2\ It is also
widely known that certain healthcare specialties, such as
anesthesiology, are associated with increased risk for abuse of and
dependency on certain classes of drugs. For this reason, ASA feels
strongly about identifying and adopting strategies that lead to
successful drug diversion deterrence programs. As a result, ASA's
Committee on Occupation Health has created a model curriculum on
substance use and disorder. This curriculum identifies the problem of
drug diversion and addiction, specifically in the occupation of
anesthesiology, detection, re-entry into the occupation, as well as
prevention. \3\
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\1\ United States Government Accountability Office, Actions Needed
to Ensure Medical Facility Controlled Substance Inspection Programs
Meet Agency Requirements, February 2017, Available at: http://
www.gao.gov/assets/690/682804.pdf
\2\ The TEDS Report, Substance Abuse Treatment Admissions Involving
Abuse of Pain Relievers: 1998 and 2008, July 15, 2001. Available at:
https://www.dea.gov/divisions/dal/2010/dallas071610.pdf?utm--
source=ABCeAlert&utm--
campaign=Hospital%20Drug%20Diversion%20Prevention&utm--content=2-20-17
\3\ SUD Curriculum, ASA Committee on Occupational Health, Tetzlaff,
John, November 12, 2015, Available here: https://www.asahq.org//media/
sites/asahq/files/public/resources/asa%20committees/substance-use-
disorder-model-curriculum-42216.pdf?la=en
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As the Committee is aware, there are institutions that already
implement successful drug diversion deterrence programs. In fact, some
of these programs have been highlighted in testimony for this hearing.
In addition, the Centers for Medicare & Medicaid Services (CMS) has
resources describing the role of practitioners in preventing drug
diversion.
Furthermore, Congress and Federal agencies have taken important
steps to curb opioid abuse and misuse. For example, during the 114th
session, Congress passed the Comprehensive Addiction and Recovery Act
(CARA), which included ASA-supported provisions to expand access to
naloxone; allow patients to partially fill prescriptions for controlled
substances; reauthorize NASPER, a public health grant program for
prescription drug monitoring programs; and enable National Institutes
for Health (NIH) to intensify pain research. Additionally, the Centers
for Disease Control and Prevention (CDC) issued the Guideline for
Prescribing Opioids for Chronic Pain, which ASA collaborated with the
agency to develop.
There has been a heightened focus by regulators to tighten
prescription requirements and work to change prescribing practices in
response to the opioid epidemic. ASA is a long-time proponent of the
use of multimodal, multidisciplinary pain management strategies
including interventional techniques that will decrease reliance on
opioids for chronic pain. While efforts to address the opioid epidemic
are underway, there is a growing need to address drug diversion. ASA
believes it is important to consider these alternative treatments as
not only a method of decreasing patient reliance on opioids, but to
also reduce the incidence of drug diversion.
The Drug Enforcement Agency (DEA) is heightening its scrutiny of
healthcare organizations. As evidenced DEA's FY 2016 Performance
Budget, there was a 9% increase in the budget devoted to Diversion
Control. \4\ It is no surprise that hospitals, surgery centers, nursing
homes, pharmacies and other organizations will be held accountable for
a lack of oversight and diligence when diversion occurs. Therefore, it
would be prudent for health care providers, including
anesthesiologists, to take preemptive steps to mitigate risks.
---------------------------------------------------------------------------
\4\ Drug Enforcement Agency, FY 2016 Budget and Performance
Summary, Available here: https://www.justice.gov/sites/default/files/
jmd/pages/attachments/2015/01/30/28--bs--section--ii--chapter-----
dea.pdf
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As previously mentioned, there are already institutions
implementing successful drug diversion deterrence programs and a lot to
be learned from the information that already exists. ASA believes that
training and education are integral to successful drug diversion
deterrence programs. ASA recommends that all employees be educated on
how to identify, detect and report potential drug diversion. It is also
important that they are able to do this anonymously, either through a
telephone hotline or other immediate method. A limited number of health
care professionals should also be properly trained on the use of
automated dispensing units, with the caution that overreliance on these
units can create a false sense of security. Multimodal pain management
techniques should be considered and employed whenever possible in order
to reduce reliance on opioids. Additionally, policies and procedures
should be developed with respect to waste/destruction of controlled
substances and segregation of duties, including the ordering, receipt,
inventory, storage, and stocking of controlled substances in different
locations. It is also advisable to frequently review drug management
data, including investigating and reviewing discrepancies on a timely
basis and conducting `unscheduled' reviews.
ASA believes it is important to proactively take steps to mitigate
the risk of drug diversion. Having procedures in place that inform
every employee of the importance of preventing drug diversion,
including disciplinary actions, can reduce risks. Even with certain
safeguards in place, institutions are vulnerable. Therefore, it is
important to work closely with and in cooperation with law enforcement,
including local police and the DEA.
ASA thanks the Committee for the opportunity to submit this
Statement for the Record and would like to offer our members as a
resource to the Committee, and also to emphasize our willingness to
work with you and the Department of Veterans Affairs to address the
issue of drug diversion.
Sincerely,
Jeffrey S. Plagenhoef, M.D.
President
American Society of Anesthesiologists
VA OIG QFR RESPONSE
March 24, 2017
The Honorable Jack Bergman
Chairman
Subcommittee on Oversight and Investigations
Committee on Veterans' Affairs
U.S. House of Representatives Washington, DC 20151
Dear Mr. Chairman:
At the February 27, 2017 hearing before the Subcommittee, Mr. Nick
Dahl, Deputy Assistant Inspector General for Audits and Evaluations,
was asked a question regarding a recent Office of Inspector General
(OIG) report, Review of Alleged Human Resources Delays at the Atlanta
VA Medical Center, that he replied to that he would provide the
information for the record.
The question was from Congressman Mike Bost dealing with the number
of background checks that were not completed at the Atlanta VA Medical
Center (VAMC) for positions that were high-risk or testing designated
positons. The Atlanta VA Medical Center did not maintain adequate
records for us to identify the number individuals who had not completed
the background investigation process during our audit work. On February
3, 2017, we requested additional information on the status of the
reviews. In a response dated February 22, 2017, the Atlanta VAMC
Director advised that they determined that 863 background
investigations needed to be adjudicated. This number varies from the
original reported backlog of 200 due to a severe lack of documentation
and subsequent discovery that Human Resource personnel performing the
background adjudication checks during this timeframe did not have the
necessary training or the minimal background level.
We request that this letter be included in the hearing record.
Thank you for your interest in the OIG.
Sincerely,
/s/
MICHAEL J. MISSAL
Copy to: The Honorable Mike Bost
[all]