United States
GAO General Accounting Office
Washington, D.C. 20548
Accounting and Information
Management Division
B-281270
June 11,1999
The Honorable Togo D. West
The Secretary of Veterans Affairs
Subject: Year 2000 Computing Crisis: Actions Needed to Ensure Continued Delivery
of Veterans Benefits and Health Care Services
Dear Mr. Secretary:
On April l&1999, we testified before the Subcommittee on Oversight and
Investigations, House Committee on Veterans’ Affairs, on the readiness of the
Department of Veterans Affairs (VA) to deliver benefits and health care services
through the turn of the century.’ In our testimony we reported that, while VA
continues to make progress, key actions remain to be performed. Specifically, (1) the
Veterans Benefits Administration (VBA) and Veterans Health Administration (IHA)
have not yet completed testing of their mission-critical systems to ensure that the
systems can reliably accept future dates, (2) VHA has not yet completed assessments
of its facility systems, (3) VHA’s pharmaceutical operations are at risk because the
automated systems supporting its consolidated mail outpatient pharmacies (CMOP)
are not yet Y2K compliant, (4) VHA does not yet include the CMOP systems in its
quarterly report of mission-critical systems to the Office of Management and Budget
(OMB), and (5) VHA does not yet know if its medical facilities will have a sufficient
supply of pharmaceutical and medical-surgical supplies on hand because it does not
have complete information on the YtZK-readiness of these manufacturers.
This report transmits our recommendations to VA for completing key actions
necessary to ensure the continued delivery of benefits and health care services to
veterans beyond January 1,200O. Our testimony, reprinted as enclosure 1, contains a
description of our objectives, scope, and methodology. As you know, we
incorporated VA’s comments into our April 15 testimony. We performed our work in
accordance with generally accepted government auditing standards.
‘Year 2000 Computing Crisis: Action Needed to Ensure Continued Deliverv of Veterans
&n&its and Health Care Services(GAOfl-AIMD-99-136,April 15,1999).
GAO/AIh!lD-99-190R
Veterans Benefits and Health Care Services
B-281270 a
Recommendations to the Secretary of Veterans Affairs
Based on our April 15,1999, testimony, we recommend that the Secretary of Veterans
Affairs ensure that the following specific actions are taken:
CompleteY2K testing of VBA and VHA mission-critical systems-including
systems acceptance testing, full future-date testing, end-to-end testing, and
business process simulation testing on compliant platforms.
Set deadlines to complete assessment, renovation, validation, and implementation
of VHA facility systems.
Develop business continuity and contingency plans for VHA CMOPs to ensure an
uninterrupted supply of medications to veterans in the event of Y2K problems at
these facilities.
ReassessVA’s decision not to report CMOP systems as mission-critical. Reporting
these systems as mission-critical to VA top management and OMB wilI help ensure
that necessary attention is paid and action taken.
Seek the assistance of the Food and Drug Administration and industry trade
associations in obtaining information on the Y2K readiness of specific
pharmaceutical and medical-surgical suppliers that did not respond to WA’s
survey, and publicize the results in a single data clearinghouse.
Apencv Comments and Our Evaluation
In commenting on a draft of this report, the Department of Veterans Affairs generally
concurred with our recommendations. VA also provided additional information on its
efforts to assure confidence in its ability to continue delivering services to veterans
and their beneficiaries. For example, it noted that all VA applications, including those
supporting benefits delivery and health care, have completed the renovation,
verification, and implementation phases. VA noted that it still needs to complete
post-implementation testing and said that testing is scheduled to be complete by
September 1,1999. VA further noted that it has completed business contingency and
continuity plans for benefits delivery and health care and that these are in place at
each of VA’s regional offkes and medical facilities. VA’s written comments are
reprinted in their entirety as enclosure 2.
This report contains recommendations to you. As you know, the head of a federal
agency is required by 31 U.S.C. 720 to submit a written statement on actions taken on
these recommendations to the Senate Committee on Governmental Affairs and the
House Committee on Government Reform not later than 60 days after the date of this
report. A written statement must also be sent to the House and Senate Committees
on Appropriations with the agency’s first request for appropriations made more than
60 days after the date of this report.
Page2 GAOMMD-99-190R Veterans Benefits and Health Care Services
r
B-281270
We are sending copies of this report to Senator Christopher S. Bond, Senator Robert
Byrd, Senator Tom Harkin, Senator Barbara Mikrdski, Senator John D. Rockefeller,
Senator Arlen Specter, Senator Ted Stevens, Representative Michael Bilirakis,
Representative Corrine Brown, Representative Sherrod Brown, Representative Lane
Evans, Representative Terry Everett, Representative Bob Filner, Representative Luis
Gutierrez, Representative Ron Klink, Representative Alan B. Mollohan,
Representative Jack Quinn, Representative Clifford Stearns, Representative Bob
Stump, Representative Fred Upton, and Representative James T. Walsh in their
capacities as Chairmen and Ranking Minority Members of Senate and House
Committees and Subcommittees. We are also sending copies to the Honorable Jane
E. Henney, Commissioner of the Food and Drug Administration; the Honorable Jacob
J. Lew, Director of the Office of Management and Budget; and the Honorable John
Koskinen, Chair of the President’s Council on Year 2000 Conversion. Copies will also
be made available to others upon request.
Should you or your staff have any questions concerning this report, please contact me
at (202) 512-6253. I can also be reached by e-mail at memssenj.aimd@gao.gov
Major contributors to this report are listed in enclosure 3.
Sincerely yours,
Director, Civil Agencies Information Systems
Page 3 GAO/AIMD99-190R Veterans Benefits and Health Care Services
Enclosure 1
GAO Testimony Dated April 15,1999
United States General Acconnting Office
GAO Testimony
Before the Subcommittee on Oversight and Investigations,
Committee on Veterans’Affairs, House of Representatives
YEAR2OO0COMPUTING
CRISIS
Action Needed to Ensure
Continued Delivery of
Veterans Benefits and
Health Care Services
Statement of Joel C. W2lemssen
Director, Civil Agencies Information Systems
Accounting and Information Management Division
j&$&g&&
GAO/T-m-99-136
Page 4 GAO/AIMD-99-190R Veterans Benefits and Health Care Services
Enclosure 1
GAO Testimony Dated April 15,1999
Page 5 GAO/AIMD-99-190R Veterans Benefits and Health Care Services
Enclosure 1
GAO Testimony Dated April 15,1999
Mr. Chairman and Members of the Subcommittee:
We appreciate the opportunity to participate in today’s hearing on the
readiness of the Department of Veterans Affairs (VA) to deliver benefits and
health care services through the turn of the century. We will focus on the
Year2000 (Y2K) readiness of automated systems that support such
delivery, the compliance status of biomedical equipment used in patient
care. and the Y2K readiness of the pharmaceutical and medical-surgical
manufacturers upon which VA relies. In discussing biomedical equipment
and pharmaceutical products, we will also share with you information on
the Food and Drug Adminlltion’s (FDA) Y2K effortz~~
In brief, VA continues to make progress in its Y2Kreadiness. However, key
actions remain co be perfornwd. For example, the Veterans Reneiits
Administration (TBA) and Veterans Health Administration (VHA) have not
yet complatad testing of their missio~ca~ systems to ensure that these
systems can reliably accept future dates-such as January 1,2000. Also,
VHA has not completed assessments for its facility systems, which can be
essential M ensuring continuing health rare. In addition, neither VA nor
FDA have implemented our prior recommendation to review the test
results for biomedical equipment used in critical cawlife support
environments. Further, Vi-IA’s pharmaceutical operations are at risk
because the automated systems supporting its consotidated mail outpatient
pharmacies are not Y2K compliant. Finally, VHA does not know if its
medical facilities will have a sufficient supply of pharmaceutical and
medical-surgical supplies on hand because it does not have complete
information on the Y2K readiness of these manufacturns. It is critical that
these concerns be addressed ifVA is to continue reliily delivering benefits
and health care.
Key Actions Remain to Likemany o~anizations, VA faces the possibility of computer system
failures at the turn of the century due to incorrect information processing
Ensure That VA Can relating to dates. The reason for this is that in many systems, the year 2000
Deliver Benefits and is indistinguishable from 1900, since the year is represented only by ‘00.”
Health Care Into the This could make veterans who are eligible for benefits and medical can
appear ineligible. If this happens, the issuance of benefits and the
Next Century
Page 6 GAO/AIMD-99-190R Veterans Benefits and Health Care Services
Enclosure 1
GAO Testimony Dated April 15,1999
1
provision of medical care that veterans rely on could be delayed or
interrupted.
As we reported last August,’ VBA had made progress in addressing the
reconmwndatiow in our May 1997 report’ and making its information
systems Y2K compliant. 1 reported it had renovated 75 percent of its
missioncritical applications as of June 1998. At the same time, VHA
reported it had assessed all and renovated the vast mqiority of its mission-
critical infonw.tion systems.
Despite this progress, VBA was making limited progress in renovating two
key mission-critical applications-the compensation and pension online
application and the Beneficiary Identification and Record Locator Sub-
System. And, except for its insurance Service, VBA bad not developed
business continuity and contingency plans for irs program services-
Comuensation and Pension (the larzesth Education. Loan Guaranty. and
Voc&onal Rehabilitation a& Cou&li$-to ens& that they would
continue to operate if Y2K failures occurred.
VHA’s YZK progmm likewise had areas of concern. For example, although
WA’s medical facilities had hospital contingency plans. as required by the
Joint Commission on Accreditation of Healthcare Organizations, they had
not yet completed Y2K business continuity and contingency plans. To
address these areas and to reduce the likelihood of delayed or interrupted
benetits and health care services, we recommended that VA
l reassess its Y2K mission-critical efforts for the compensation and
pension online application and the Beneficisq Identification and
Record Locator Sub-System, as well as other information technology
initiatives, such as special projects, to ensure that the Y2K efforts have
adequate resources, including contract support, to achieve compliance
in time;
l establish critical deadlines for the preparation of business continuity
and contingency plans for each core business process or program
service so that missionuitical functions affecting benefits delivery can
be carried out even if software applications and commercial-off-the-
GAO/AIMD-99-19OR Veterans Benefits and Health Care Services
Enclosure 1
GAO Testimony Dated April 15,1999
shelf (COTS) products fail, including a description of resources, staff
roles, procedures, and timetables needed for implementation; and
l ensure rapid development of business continuity and contingency plans
for each medical facility so that mission-critical functions affecting
patient care can be carried out if software applications, COTS products,
and/or facility-reIated systems and equipment do not function properly,
including a description of resources, staff roles, procedures. and
timetables needed for implementation4
VA Continues to Make VA has been responsive to our recommendations. For example, VBA
Progress reassessed its missionsriticai effoas for the compensation and pension
online application and the Beneficiary Identification and Record Locator
SubSystem, as well as other information &xhnoIogy initiatives. it also
reallocated resources to ensure that the Y2K efforts had adequate
resources, including contract support, to achieve compliance.
In addition, VBA completed a dmft business continuity and contingency
plan in January 1999 for its core business processes, as well as a related
planning template for its regional oflices. The plan provides a high-level
overview of the resmrces, staff roles, procedures, and timetables for its
implementation. It addresses risks, includii mitigation~actions to reduce
the impact of Y2K:mduced business failures, and analyzes the effect on
each business line of a number of potential Y2K disasters-such as loss of
electrical power, loss of communications, loss of datilprocessing
capabilities, and failure of internal inlrastructurc. According to VBA, the
plan, which it expects to test this August, is an evolving document, to be
revised and updated periodically untilJanuary 1.2000.
VBAk plan makes no reference to contingencies for the failure of three of
VB& benefit payment systems-Compensation and Pension, Education,
and Vocational Rehabilitation and Counseliw. However. it is currentlv
developing a payment contingency plan for these systams and expects this
to be completed in May 1999. A VBA o~cial told us that the payment
contingency plan should have beenraferencedin VU’s business continuity
and contingency plan and will be in future versions. The current plan also
does not contain the designation of an infmmation technotogv security
coordinator and a physical security coordinator-individualsthat VBA
acknowledges are essential to the agency’s Y2K efforts-with responsibility
Page 8 GAOIAIMD-99-19OR Veterans Benefits and Health Care Services
Enclosure 1
GAO Testimony Dated April 15,1999
for ensuring overall security for VBAs network and web site and backing
up data storage before, during, and following January 1,2CC0. This type of
information will be necessary if security-related failures occur. According
to VBA, it expects to designate these individuals by August 1999.
VHA has also made progress in developing business contfnui~ and
contingency plans for its medical facilities. Last month. VHA issued its
Patient-Focused Year 2000 Contingency Planning Guidehook to its medical
facilities describing actions they can take to minindze Y2K-related
disruptions to patient care. The guidebook discusses how the facilities
should develop contingency plans for each major hospital function-such as
radiology, pharmacy, and laboratory+s well as each major support
function-such as telecommunications, facility systems, medical devices,
and automated information systems. The guidebook also contains
examples of plans, policies, and solutions for problems that a medical
faciiity may face and provides Y2K templates describing the areas a facility
should address by specific hospital function. VA provided this guidebook
to the medical facilities early last month and expects the facilities to use it
to prepare their individual business continuity and contingcncyplans, set
to be completed by April 30. The guidebook stresses that these plans
should be tested and suggesrs that the medical facilities be&t testing in
June.
The guidebook addresses external emergency preparedness se weIl as
int.emal operations. Specifically, it discusses three functions that medical
facilities should perform in order to ensure thal potential external hazards
are considered and planned for. Theseare (1) performing an assessment of
hazard vulnerabilities-that is, the types and kinds of Y2Kproblems that are
anticipated within the community, (2) conducting an inventory of
conununity resources-people. money, clinical space, supplies, and
equipment-available to address these hazards, and (3) closing the gap
between vulnerabihties and capabilities by putting into place measures that
will mitigate potential diiptions in critical servicers by developing new
working relationships with Various government agencies, non-VA he&h
care organizations, and vendors of crhical auppliis.
1x1addition to implementing our recommendations, VA continues to make
progress renovating, validating, and implementing its systems. On
March 31.1999, VA reported to the Office of Management and Budget
(OMB) that the department has renovated and implemented all of the
mission-critical applications supporting its 11 .systems areas. As shown in
table 1, VBA has six of these areas, and VHA has two.
GAOIAIMD-99-19OR Veterans Benefits and Health Care Services
Enclosure 1
GAO Testimony Dated April 15,1999
Table 1: Reported status of VA’s Mirsion-Clitisel Cornput& Systems Amas kd ”
Their Appllcattona
Number of applications
renovated DI **Placed
Veterans Benefits Compensattm and Pension 30
Administration (6) Fd,nwnn 74
Loan Guaranty 19
Vocational Rehabilitatiin 4
Administmtiue 27
V’dlerans Health v*temns Hs*th 1”tommtion
Admtntstrabn (2) Systems and Technolagy
Archttectur.3
Vet%ms Health Administration
Corporate Syslems
Total
National Cemetety Burial opeatians support S~Srn/
System (1) Automated Monument Application
System
Reengineer
mtat
Ollice 01 Financial Petsannel and Accounting
fdanegement (2) tntegrated Data
Ftnamial Management System
Total
v* total II
-3 mir Wtal.316 appllcatiDnswere re”wat8d snd two welo mpaw3.
Source: “A. We hm not independen~vsrifipdthlrfn~rmatl~n.
Testing of Mission-Critical Complete and thorough Y2K testing is essential to providing reasonable
Systems Not Yet Complete assurance that new or modified systems will process dates correctly and
will not jeopardize an organization’s ability to perform core business
operations.~ Because the YZK problem is so pewasive, potentially affecting
an organization’s systems software, applications soffnrare, databases,
hardware, firmware, embedded processops, tekcommunicaticns, and
Page 10 GAO/AIMD-99-19OR Veterans Benefits and Health Care Services
Enclosure 1
GAO Testimony Dated April 15,1999
interfaces, the requisite testing can be extensive and expensive.
Experience is showing that YZK testing is consuming between 60 and 70
percent of a YZK project’s time and resources.
According to our Y2K guide, to be done effectively, testing should be
planned and conducted in a shuctured and disciplined fashion. Our guide
describes a step-by-step framework for managing MK testing, which
includes the following key processes:
* Software unit testingto verify that the smallest defined module of
software (individual subprograms or procedures) continues to work as
intended.
l Sotham integration tcscingto verify that units of sofhvare, when
combined, contiiue to work togetheras intended. ?srpicalJy,integration
testing focuses on ensuring that the interfaces work correctly and that
the integrated softwsre meetS requirements.
l System acceptance testing to verify that the complete system-that is,
the full complement ofapplication software running on the target
hardware and systems software infrastructure-satisfies specific
requirements and is acceptable to users. This testing can be run
separately or in some combiition in an operational environment
factual or simulated) and collectively veiifles that the entire system
performs as expected.
According to VBA and VHA officials, their testing criteria were based on
theirsoftware development life cycle guidance documents. They said that
upon completion of software unit and integration testing, a system is
considered Y2K compliant. They said this type of testing had been
completed for all of their mission-critical systems.
As of March 31,1999, neither VBA nor VHA had completed systems
acceptance testing-which requires that each system be tested, includii
full forward-date testing, on a compliant platform-for all their mission-
critical systems. Specifically, according to VBA officials, the agency had
completed systems acceptance testing for half of its mission-critical
systems-Insurance, Loan Guaranty, and Vocational Rehabilitation and
Counseling. According to VW’s Man% 1999 draft test plan, systems
acceptance testing of the Compensation and Pension and most of the
Education systems was to start in mid-April 1999. According to a VBA
official. one of the reasons for the late systems testing was that the IBM
platfom at its Hines, Illinois, data center was not made Year 2000
GAOfAIMD-99-190R Veterans Benefits and Health Care Services
Enclosure 1
GAO Testimony Dated April 15,1999
compliant until the compiler’ was upgraded in February 1339. According
to VBA, the Compensation and Pension and most of the Education systems
will be future-date tested throughout April.
VHA also plyls to begin system acceptance testing of its missioncritical
systems this month and complete it this June. According to VHA officiaLs,
they could not perform thii type of testing before March of this year
because VHA did not have a separate YZK-compliant test environment to
isolate the testing from the hospital systems in use.
In addition to testing of individual systems, end-to-end testing of multiple
systems GGalso critical. End-m-end testing, as defined lo our test guide,
verities that a defined set of interrelated systems, which collectively
support an organizational core business area or function, continues to
work as intended inan operational environment, either actual orsimulated.
For example, in order to successfully process a compensation benefit
payment to aveteran, VBXs Compensation and Pension System must work
correctly with its Beneficimyldentitication and Records Locator Sub-
System. Treasury’s Financial Management System, the Federal Reserve
System, and fmancial institution systems.
VBA and VHA plan to conduct end-mend testing between now and this
July. VBA is defining end-to-end testing as verification that core mission-
critical business functions, including benefit payments and vendor and
payroll payments, process correctly. The interfaces behveen VBA’s benefits
system and ~easu& Financial Management System are to be tested in
May. VBA also plans to test transactions that interface with WA syxems,
such as infomratian related toveteran eligibility. VITA is defining end-t-
end testing as verification that core missionaitical business fununctions,
includii patientcare transactions and vendor and payroll payments,
process correctly. Once these tests are completed. VBA and VHAplan to
conduct a %usiness process simulation” during the July 4,1999, weekend.
This simulation of day-today work at VA is to include users at the VBA
regional offkes and VHA test laboratories, who wlIl simulate various
transactions and process them through a set of interrelated systems
necessary to complete a core business function. VBA expects to pretest the
business process simulation during May.
Page 12 GAO/AIMD-99-190R Veterans Benefits and Health Care Services
Enclosure 1
GAO Testimony Dated April Xi,1999
Assessment of VHAk VAk facility systems are essential to the continued delivery of health care
Facility Systems Not Yet sctices. For example, heating, ventilating. and air conditioning equipment
is used by hospitals to ensure that contaminated air is confined to a
Complete specified area such as an isolation room or patient ward. If computer
systems used to maintain these syst~s were to fail, any resulting climate
fluctuations could affect patient safety.
Despite their importance, WA has not yet completed its ascssment of
facility systems. As of February 28,1939, VHA medical facilities reporccd
that they had assessed 55 percent of their facility systems. According to
VHKs Director of Safety and Technical Programs, the remaining 45 percent
have not been folly assessed primarily because (1) facility systems tend to
be a combination of unique elements that have to be separately assessed
for compliance-a timecousumingproce-and (2) WA is still awaiting
compliance status information from facility systemmanufacturers. VHA
has not established milestones for completing its assessment and
implementation of compliant facility systems. To help ensure that sufficient
time remains to complete these activities, we recommend that VHA
consider setting such deadlines.
In the event that facility-related systems and equipment do not function
properly due to Y2K problems. VHA medical facilities will need to ensure
that they have business continuity and contingency plans addressing how
mission-critical functions affecting patient care will be carried out.
According to WA’s Director of Safety and Technical Programs, most of its
facility systems have some kid of manu.s.loverride or reset that will allow
them to continue functioning after a YZK problem. He agreed, however,
with the importance of developing contingency plans lhat fully document
continued delivery of essential services in the event of a facility system
failure. WA medical facilities expect to have individual business
continuity and contingency plans completed by April 30.
On April 14.1999, VA informed us that its February 28,13Q9.report
contained an error. The corrected numbers for facility systems at the end
of February were 91 percent assessed and 3 percent not assessed.
Page 8
GAOIAIMD-99-190R Veterans Benefits and Health Care Services
Enclosure 1
GAO Testimony Dated April 15,1999
BiomedicalEquipment: The question of whether medical devices such as magnetic r&onance
imaging (MRi) systems, x-ray machines. pacemakers, and cardiac
Additional Status monitoring equipment can be counted on to work reliably on and after
Information Available, January 1,2000, is also critical toVHA To the extent that biomedical
But Test Results Not equipment uses embedded computerchips, it is vulnerable to the Y2K
problem. Such vulnerability carries with it possible safety risks. This could
Reviewed range from the more benign-such as incorrect formatting of a printout-to
the most serious-such as incorrect operationof equipment with the
potential to adversely affect the patient. The degree of risk depends in
laq$e pat on the role the equipment playsin a patient’care.
s
Additional Biomedical Last September we testified before this Subcommittee that VHAwas
Equipment Status making progress in assessing its biomedical equipment, but that it did not
Information Available know the full extent of the Y2K problem with this equipment because it had
not received compliance information from 398 manufacturers (26.7
perccnt).7 According to WA, as ofMarch 16, 1999, the number of
nonresponsive manufacturers had been reduced to 126 (3.5 per~ent).~ As
shown in tile 2, about 19 percent of the manufacturers in VIWs database
of suppliers had at least one biomedical equipment item that was either
noncompliant or conditionally compliant.
Page 14 GAO/AIMD-99-190R Veterans Benefits and Health Care Services
Enclosure 1
GAO Testimony Dated April 15,1999
Table 2: Status of Hanufactwer Responses to VHA 8% of March I&“1999
Category
Compliant manuladurersa 816 55.2
Noncompliant manufacture& 126 6.5
Conditinalcompliant manufacturersc 156 10.5
Pending manulactumrsd 29 2.0
Manufadurers mergedar bought cd 226 15.3
Nonresponsive manuIadurers’ 126 a.5
Total 1,479 100.0
*For i”duSim inthlscatsgory. IW pe”xnt 01 the tnmyIB”“rer’s products hadlo be c&dwed
mmptiant.
To identify specific biomedical equipment in the inventories of WAS
medical facilities that still require Y2K compliance status information from
manufacturers, V?Ws Chief Network Oflker sent a letter to the directors of
VEiA’s 22 Veterans Integrated Service Networks (VISN). This letter
requested that they (1) review VIWs list of manufactw.?rs that have yet to
respond and compare it with a list of manufacturers from whom their
medical facilities still require compli~e information and (2) indicate the
equipment item that the facility owns for each matmfacturer. According to
VHA’s YZK project director, as of mid-March-with 136 of 147 medical
reporting sites-47 biomedical equipment items involving 35 manofactorers
were identified as still requiring compliance stauis information. The
project diitar told us that VHA medical facilities have been instructed to
replace or eliminate equipment in their inventories for which they do not
know the compliance status by June 30. According to WA’s February 1999
status report on medical devices, medical facilities &mated that the total
cost of renovations will be about $41 million.
Page 15 GAOIAIMD-99-190R Veterans Benefxts and Health Care Services
Enclosure 1
GAO Testimony Dated April 15,1999
We have previously reported that most manufacturers citing noncompliant
producti listed incorrect display of date and/or tie as the Y2K problanY
According to VA, these cases do not present a risk to patient safety because
health care providers, such as physicians and numes, can work around the
problem. Of more setious concern are situations in which devices depend
on date calculation.+the results of which can be incorrect One
manufacturer cited the example of a product used for plawing delivay of
radiation treatment using a radioactiie isotope zs the source. An error in
calculating the strength ofthe radiation source on the day of treatment
could result in a dose that is too high or too low, which could have an
adverse effect on the patient. Other examples of equipment presenting a
risk to patient safety identified by manufacturers to FDA include
hemodiiysis delivery systems, therapeutic apheresis system~,‘~ alpha-
fetoprotein kits for neural tube defects;” various types of medical imaging
equipment; and systems that store, track. and recall images in
chronological order.
To track the compliance status of its biomedical equipment, WA uses a
monthly status report on medical devices based on information provided
by the VISNs. According to the February 1999 report, appmximatcly
426,000 o1531.000medical devices in VIIA medic& facilities are compliant.
Of the remaining devices, 86,452were identified as conditional-compliant
or were not assessed for Y2K compliance because the manufacturers
certified that the equipment contained no software or embedded chips, and
19,073were reported as being noncompliant Of the noncompliant devices
identified, 15,621are to be repaired, 1,582 are to be replaced, 757 are to be
used as is. 255 are to be retired, and 855 are still awaiting a decision on the
remedy. According to WA’s Chief Biomedical Engineer, most of the
noncompliant devices identif%edincorrectly displayed date/time.
As we reported last September, FDA was also trying to determine the Y2K
compliance status of biomedical equipment.‘” Its goal is to provide a
pal .._ s.l”mn~
K?40/.4lMD98240,
September
LB.Pxe).
Page 16 GAOIAIMD-99-190R Veterans Benefits and Health Care Services
Enclosure 1
GAO Testimony Dated April 15,1999
comprehensive, centralized source of information on the Y2K compliance
status of biomedical equipment used in the United States and make this
information publicly available on a web site. At the time, however, FDA
had a disappointing response mte from manufacturers to its letter
requesting compliance information. And, while FDA made thii
information available to the public, it-was not detailed enough to be useful.
Specifically, FDAS lii of compliant equipment lacked information on
particular make and model.
To provide more detailed information on the compliance status of
biomedical equipment, as well as to intsgratc more detailed compliance
information gathered by K-X, we recommended that VA and the
Department of Health and Human Services @HS) jointly develop a single
data clearinghouse that provides such information to all users. We said
development of the clearinghouse should involve representatives from the
health care industry, such as the Department of Dcfcnse and the Health
Industry Manufacturers Association. We recommended that the
clearinghouse contain such information as (1) the compliance status of all
biomedical equipment by make and model and (2) the identity of
manufacturers that are no longer in busins%%.We also recommended that
VHA and FDA dctcnnine what actions should be taken regarding
biomedical equipment manufacturers that have not provided compliance
infoItnation.
In response to our recommendation, FDA-in cor(iunction with VI&%-has
established the Federal Year 2OKJBiomedical Equipment Clearinghouse.
With the assisrance of VHA, the Department of Defense, and the Health
Industry Manufacturers Association, FDA has made progress in obtaining
compliance-status information from manufacturers. For exampie,
according to FDA, as of April 5,1999,4,261 biomedical equipment
manufacturers had submitted data to the clearinghouse. As shown in
f@ue 1, about 64 percent of the manufacturers reported hating products
that do not employ a date, while about 16 percent reported having date-
related problems such as incorxct display of date/time. FDA is still
awaiting responses from 399 manufachuers.
L
GAO/AIMD-99-190R Veterans Benefits and Health Care Services
Enclosure 1
GAO Testimony Dated April 15,1999
Figurel: Biomedical EquIpmentCompliance-S~~sIntDrma;ion Reportedto FDAby
t&n”‘aCtUrers as ot April 5.1999
FDA has &o expanded the information in the cletinghouuse. For example,
users can now find information on manufaausers that have merged with or
have been bought out by other tims In collaboration with the National
Patient Safety Partneahip,” FDA is in the process of obtaining more
detailed information from manufacturers on noncompIian& products, such
as make and model and descriptions of tbe impact of the YZK problem on
products MtuncoHected.
Page 18 GAO/AI&ID-99-19OR Veterans Benefits and Health Care Services
Enclosure 1
GAO Testimony Dated April 15,1999
Review of Biomedical We reported last September that VHA and FDA r&cd on manufacturers to
Equipment Test Results validate, test, and certify that equipment is YZK compliant’” We also
reported that there wss no awxance that the msnufacturers adequately
Lacking addressed the Y2K emblem for noncompliant equipment because F’IIA did
not require medi&dsvice manufacture& to submit test results to it
certifying compliance. Accordingly, we recommended that VA and HHS
take prudent steps fo jointly review manutacturem’ compliance test results
for critical careA& support biomedical equipment. We were especially
concerned that VA and FDA review test results for equipment previously
detcnnined to be noncompliant but now deemed by manufacturers to be
compliant, or equipment for which concen~ about compliice remain. We
also recommended that VA and HHS determine what legislative, regulatory
or other changes were ncc~sary to obtain assursnccs that the
manufacturers’ equipment was compliant, including performing
independent vezitication and validation of the manufacturers’
certiflications.
At the time, VA stated that it had no legislative or regulatory authority to
impk.ment the recommendation to review test results from manufacturers.
in its response, HHS stated that it did not concur with OLUrecommendation
to review test results supporting medical device equipment manufacturers’
certifications that their equipment is compliant. It believed that the
submission of appropriate certTfications of compliance was sufficient to
ensure that the certifying manufacturers are in compliance. HHS also
stated thar it did not have the resources to undertake such a review, yet we
are not aware of HHS’requesting resources from the Congress for this
Purp==.
More recently, VHAk Chief Biomedical Engineer told us that VB.A medical
facilities are not mque9ting test results for critical ca&life support
biomedical equipment; they aiso are not curently reviewing the test results
available on manufacturers’ web sitcs. He said that VHA’s priority is
determining the compliance status of its biomedical equipment inventory
and replacing noncompliant equipment. The director of FDAk Division of
Electronics and Computer Science likewise said FDA sees no need ta
question manufacturers’ certifications.
Page 19 GAO/AIMD-99-190R Veterans Benefits and Health Care Services
Enclosure 1
GAO Testimony Dated April 15,1999
In contrast to WA’s and FDXs ~ositiors. some hospitals in the private
sector believe that testing hio&edical eq&ment i.~ncceesary to prove that
they have exercised due diligence in the pmtection of patient health and
safety. Officials at three hospitals told us that their biomedical engineers
established their own test programs for biomedical equipment, and in many
cases contacted the manufacturers for their tat protocols. Several of
these engineers informed us that their testing identified some
noncompliant equipment that the manufacturers had certified as
compliant. Accordiig to these engineers, to date, the equipment found to
be noncompliant all had diibxy problems and was not critical care/life
support equipment. We were told that equipment found to bc incorrectly
certified as compliant included a cardiac catheterization unit, a pulse
oxymeter, medical imaging equipment, and ultrasound equipment.
WA, FDA, and the Emergency Care Research Institute” continue to
believe that manufacturers are best qualified to analyze embedded systems
or software to determine YZK compliance. They further believe that
manufacturers are the ones with full access to all design and operating
parameters contained in the internal software or embedded chips in the
equipment VHA believes that such testing can potentially cause
irreparable damage to expensive health care equipment, causing it to lock
up or otherwise cease functioning. Further, a number of manufacturers
also hwe recommended that users not conduct veriliration and validation
testing.
We continue to believe that rather than relying solely on manufacturers’
certifications, organizations such as VfL4 or FDA can provide users of
medical devices with a greater level of confidence that the devices are YZK
compliant through independent reviews of manufacturers’ compliance test
results. The question of whether to independently verify and validate
biomedical equipment that manufacturers have certified as compliant is
one that must be addressed jointly by medical fac!Mies clinical sti,
biomedical engineers, and corporate management. The overriding
crimion should be ensuring patient health and safety.
Page 20 GAOIAIMD-99-19OR Veterans Benefits and Health Care Services
Enclosure 1
GAO Testimony Dated April 15,1999
VHA Pharmaceutical Another critical component to VA’s ability to deliver health care at the turn
of the century is ensuring that the automated systems supporting VHA’s
Operations Also Face medical faciliQ pharmacies and its consolidated mail outpatient
YZK Risks pharmacies (CMOP) are Y2K compliant. VEXAreported that in 1998. itfmed
about 72 million prescriptions for3.4 million veterans, at an estimated cost
of about $2 billion. About half of the prescriptions were tilled by the over
200 pharmacies located in%% medical centers, clinics, and nursing homes.
These pharmacies rely on the pharmaceutical applications in the Veterans
Health Information Systems Architecture (VIST.4) for (1) drug distribution
and inventory management, (2) dispensing of drugs to inpatients and
outpatients, (3) patient medication information, and (4) an electronic
connection between the pharmacies and the CMOPs. Y2K failures in these
applications could impair the pbarnmcies ability to fill prescriptions.
The remaining 50 percent of VHA’s prescriptions are tilled by seven CMOPs,
geographically located throughout the United States. These facilities are
supported by automated systems provided by one of two contractors-
SUBaker, Inc. and Siemens ElectroCom. ” For example, the CMOP
electronically receives a prescription for a veteran through the medical
center. The prescription is downloaded to highly automated dispensing
equipment to he filled. The tilled prescription is then validated by a
pharmacist who compares the medication against a computerized image of
the prescribed medication. Afterward, the prescription is packaged and an
automatically generated mailing label is applied for delivery to the veteran.
Finally, the medical center is electronically notified that the prescription
has been Jilled. Because of the reliance on automation, the CMOPs’ abiity
to ffl prescriptions could be delayed or interrupted if a YZK failure
occurred.
VHA has determined that the automated systems supporting its CMOPs are
not Y2K compliant. Specifically, neither of the systems provided by their
contractors are Y2K compliant. According to the Y2K coordinator for the
SI/Baker facilities, failure to make the SyBaker systems Y2K compliant
may delay the fu of outpatient prescriptions. The SI/Baker systems are
used by three of VI-I& CMOPs-Hines, IUinois; Charleston, South Carolina;
and Mmfreesboro, Tennessee; they handle about 58 percent of all
prescriptions filled by CMOPs. In contrast to the SUBalter systems,
according to a contractor hid by the CMOPs that use these sysrems,
Page 21 GAO/AIMD-99-190R Veterans Benefits and Health Care Services
Enclosure 1
GAO Testimony Dated April 15,1999
failure to make tbe Siemens ElecPoCom systems YZK compliant may result
in delays in processing management reports for prescriptions filled, but not
the actual tilling of prescriptions.
Although the CMOPs plan to replacetheir noncompliant systemswith
compliant ones, these systems are nbt scheduled to be implemented until
mid- to late-1999. As shown in table 3, the earliest estimaed completion
date for implementing a compliant system is June 30.1999. while the latest
is December 1.1999. This leaves little time to address any unexpected
implementation problems.
15.000
June 30.1999 16,000
June 30.1999 14.ow
July 31.1999 16.000
septemmr 1. 1999 23,000
September SO, 1999 3B.000
December 1.1999 21.000
Given the late schedule for implementing compliant sy#ms, it is crucial
that the CMOPs develop business continuity and contingency plans to
enswe that veterans will continue to receive their medications if these
systems are not implemented in time or fail to operate properly. AS of
March 31. VA had not completed a business continuity and contingency
plan for the GMOPs. The YZK coordinator for the Siemens ElectroCon~
system has been tasked with developing this plan. which is to be completed
by the end of thii month.
Further, VA did not include the CMOP systems in its quarterly reports of
missioncritical systems to OMB. According to Ws Y2K project direcror,
VHA considered the GMOP systems to be COTS products and, therefore,
Page 22 GAOIAIMD-99-190R Veterans Benefits and Health Care Services
Enclosure 1
GAO Testimony Dated April 15,1999
did not report them as mission-critical systems. Given the criticality of
these systems to VHA’s ability to ffi prescriptions at thetorn of the century,
we believe VA should reassess this decision, reportiog CMOPs as mission-
critical to VA top management and OMB to help ensure ti-& neefssaxy
attention is paid to and action is taken on them.
VA Taking Action to VA, like otber users of pharmaceutical and medical-surgical products.
~~~~ YAK ~~~~~~~ ,,f needs to know whether it will have a sumdent supply of these items for its
Pharmaceutical and customers. Themfore, it has taken a leadership role in lhe federal
gowmment in determining whether manufacturers supplying these
Medical-Surgical productsto VHA are Y2K-ready. This information is essentii to VII&
Manufacturers medical faciiities and CMOPs because of their “just-in-tin&t7 inventory
policy. Accordiigly, they must know whether theirmarmfacturers’
processes, which are highly automat.ed,‘8 ace at risk, as well as whether the
rest Of the supply chain will function properly.
To determine the Y2K readiness of their suppliers, on January 8,1999, VA’s
National Acquisition Center (NAC)” sent a survey to 334 phatmaceutical
firms and 459 medicalsurgical firms with which it does business. The
survey contained questions on the fums’ overall YZX status and inquired
about actions taken to assess. inventory, and plan for any perceived impact
that tbe century tomover would have on their ability to operate at normal
levels. In addition, the tirms were asked to provide status information on
progress made to become Y2K compliant and a reliable estimated data
when compliance will be achieved for business processes such as
(1) ordering and receipt of raw materials, (2) mixing and processing
product, (3) comph?ting fiial product processing, (4) packaging and
labeling product, and (5) distributing fmished product to distributors/
wholesalers and end customers.
According to NAC ofEci&, of the 465 firms that responded to the survey as
of March 31.1999, about 55 percent completed all or part of the survey.
The remainder provided general information on their Y2K readiness stahrs
Page 23 GAO/AIMD-99-19OR Veterans Benefits and Health Care Services
Enclosure 1
GAO Testimony Dated April 15,1999
or litemtwem on their efforts. As shown in table 4, more than half of the
pharmaceutical fums surveyed responded (52 percent), with just less than
one-third (37.percent) of those respondents reporting that they are
compliant. Among the pharmaceutical fkms that had not responded as of
March 31, however, were two of VA’s five largest sup~Iiem.~ The three
large pharmaceutical suppliers that did respond provided general
informaticm on their Y2K readiness status, rather ihan answering the
survey, and enimated thatthey will be compliant by June 30,1999.
Table4: Status of CompaniesSutvsycd by “Ii* as of March31.1999
Table 4 also shows that 54 percent of the medical~wgical tkms surveyed
responded, with about two-thirds of them (166) repating that they are Y2K
compliant. All five of Vlis lzugea medicalsurgical suppliers have
responded. Spec’fically, two reported being compliiant, two reported they
would be compliant by June 30,1999, and the remaining supplier did not
report an expected compliance date.
On March 17,1999, NAC sent a second letter to its pharmaceutical and
medical-surgical fums, infaming them of VA’s plans to make YZK readiness
information previously provided to VA available to the public through a
web site (wwxva.gov/cx&m1tina/nady2k). VAmade the survey results
available an its web site on April 13, 1999. The letter also requested that
Page 24 GAOIAIMD-99-190RVeterans Benefits and Health Care Services
Enclosure 1
GAO Testimony Dated April X,1999
manufacturers that had not previously responded provide information on
their readiness. NAG Executive Director said that he would personally
contact any major VA supplier that does not respond. On a broader 1~4
VHA has taken a leadership role in obtaining and sharing information on
the YZX readiness of the oharmaceutical industw. Suecif~caW. VHA chairs
the Year 2000 Pharmace&cals Acquisitions andDi&ibution~
Subcommittee, which reports to the Chair of the President’s Council on
Year 2000 Conversion. The purpose of this subcommittee is to bring
together federal and pharmaceutical representatives to address issues
concerning supply and distribution as they relate to the yew 2000. The
subcommittee consists of FDA, federal health care providers, and industry
trade associationssuch as the Pharmaceutical Research and Manufacturers
of America (PhRMA), the National Association of Chain Drug Stores, and
the National Wholesale Drug&w’ Association. Several of these trade
associations have surveyed their members on their Y2K readiness and
made the results available to the public. Ilowever. the information is not
manufacturer-specific or as detailed as VHA’s survey results.
FDA’s Y2K Efforts for FDA’s oversight and regulatory responsibility for pharmaceutical and
Pharmaceutical and biological produc@ is to ensure that they are safe and effective for public
Biological Products use. Because of its concern about the Y2K impact on manufactun?rs of
these products, FDA has taken several actions to raise the Y2K awareness
Industries Were Initially of the pharmaceutical and biological products industries. In addition. it is
Focused on Awareness thinking about conducting a survey to determine the industry’s Y?.K
readiness.
One of FDA’s actions to raise industry awareness was the danwry 1998
issuance of indus!ay guidance by the Center for Biologics Evaluation and
Research (CBER) on the Y2K impact of computer systems and software
applications used in the manufacture of blood products. In addition, as
shown in table 5, FDA has issued several letters to pharmaceutical and
biological trade associations and sole-source drug manufacturers.
Page 25 GAO&MD-99-190R Veterans Benefits and Health Care Services
Enclosure 1
GAO Testimony Dated April l&l999
Table 5: FDA Letters to Msnutacturerc Regarding YZK
Purpose
To relay to msrnbers FDA% axpectaticm that the
pharmawticat industry would (1) make resolution of
YZK a htgh priority. (2) ensure that prOduction SWemS
were tixed and tested prior in January 1.2000. and (3)
ume menufacturew to dB”e.lW YZK rn”ti”oe”cv da”*.
October Center for Siologics Bidogtcs manufacturer trade Same as above.
,898 Evaluatim and Research a.ssDclatiDns
January 1999 centerior Sole-source drug Same as above. Also (1) noted thal the impact of YZK
Drug Evaluation and manutacturers w, pharmaceutical sat&y, efllcaoy, and availability
Research merits special attention fw lirms who are the sole
mnufachrmrs af drug mmponants bulk ingredients.
and Cmitwd prcdwts and (2) statedthat
pharmaceutical indusby suppEers must have YZK-
mmpliint systems to protect agatnst diiruptkm in the
ROWof pmduct camponenb. packaging materials. and
equipment to pharmaceutical manufacturers
Further, ort February 11,1999, FDA’s director of emergency and
investigation operations sent a memorandum on FDA!s interim inspection
policy for the YZK problem to the directors of FDA’s investigations branch.
The policy emphasizes FDA’s Y2K awareness efforts for manufacturers. It
states that FDA inspectors are to (1) inform the firm of FDA’s Y2K web page
(URL hnp:/~~dagov/cdr~rgO~4e~gOOO.h~I~, (2) provide the fum
with copies of theappropriate FDA Y2K awareness lettex, (3) explain that
Y2K problem could potentially affect aspefts of the firm’s operations,
includinn some areas not reeulated by FDA. nnd that FDA anticipates that
fums will take prudent steps to ens&c that’they are not adversely affected
by YZK, and (4) provide fvms with a copy of FTNe compliance policy guide
*Year 2000 (YZK) ComputerProblems.”
In addition, FDA and PbRMA jointly held a governmentlindustrg forum on
the Y2K preparedness of the pharmaceutical and biotech industries on
February 22.1999. The objectives of t&is forum ‘Ivenv to (1) share
information on Y2K programs conducted by health care providers,
phmmceutical companies, FDA, and other federal agencies. (2) provide a
vehicle for networkin!& and (3) raise awareness.
On March 231999, FDA revised its February 1 I, 1999, interim inspection
policy. The revision states that field inspectors are now to inquire about
manufactuxem’ efforts to ensure that their computer-conWoUed or date-
Page 26 GAOMMD-99-190R Veterans Benefits and Health Care Service:
Enclosure 1
GAO. Testimony Dated April 15,1999
sensitive manufacturing processes and distribution systems are Y2K
compliant. Inspectors are to include this information in their reports, along
with a determination of activities that fums have completed or started to
ensure that they will be Y‘ZK compliant.
Further, FDA inspectors may review~diocumcntation in cases in which firms
have made changes to their computerized production or manufacturing
control srjtems to address WK problems, The purpose of this review is to
ensure Chatthe changes were made in accordance with the firms’
procedures and applicable regulations. If inspectors determine that a firm
has not taken steps to ensure YZK compliance, they are to notify their
district managers and the responsible FDA center.
FDA’s interim policy describes steps inspectors an to take in reviewing
manufacturers’Y2K compliance. However. FDA stated that the primary
focus of its inspections for the remainder of 1999 will be to ensure that
products sold in the United States arc safe and effective for public use and
comply with federal statutes and regulations, including “good
manufacturing practice” (GMP).23 FDA ofticiale explained that the agency
does not have sufficient resources to perform both regulatory oversight of
the manufacturers and in-depth evaiuations of firms XX compliance
activities.
Nevertheless, according to the March 29,1999, memorandum, field
inspecton are to note any concerns they may have with a fii’s Y2K
readiness in the admiitrative remarks section of their inspection reports.
These reports are to be reviewed by FDA district managers. If the Y2K
concern appears to present a serious problem to a Grm’s ability to produce
safe, effective medication, the district manager can discuss this issue with
FDAk Offke of Regulatory Affairs and determine a course of action.
However, FDA offIcizds have stressed that the agency cannot take any
regulatory action toward the fum until a Y2K-related problem affects a
pharmaceutical or biological product.
LikeVHA. FDA is interested in the impact of Y2K readiness of
pharmaceutical and biological products on the availability of products for
health care facilities and individual patients. FDA3 Acting Deputy
Commissioner for Policy informed us on bfarch 24,1999. that the agency is
Page 27 GAO/AIMD-99-190R Veterans Benefits and Health Care Services
Enclosure 1
GAO Testimony Dated April 15,1999
thinking about surveying pharmaceutical and biological products
manufacturers, distributors, product repackagers, and others in the drug
dhensine chain. on their Y2Kreadiness and contingency planning. In
an&zip&n of a &ssible survey, the agency has publish&a notice in the
March !z2, 1999, -regarding this matter. The Acting Deputy
Commissioner said that potential survey questions on contingency
planning would include steps the manufacturers are taking to ensure an
. adequate supply of bulk manufacturing materials from overseas suppliem.
l’hk is a key issue because, as we reported in March 1998.” according to
FDA. as much as 80 percent of the bulk pharmaceutical chemicals used by
U.S. manufacturers to produce prescription drugs is imported.
In summary, VBA and VHA continue to make progress in preparing their
missioncritical systems for the year 2000. However, key actions remain to
be taken in the ereas of mission-critical systems testing, VHA facility
systems compliance, and CMOPsystems compliance. We also reiterate the
need for vH?L and FDA to take prudent steps to ensure that the tesf results
of critical care/life support biomedical equipment are obtained and
reviewed. Finally, VHA needs information on the Y2R readiness of specific
pharmaceutical and medic&surgical manufacturers. Until this information
is obtained and publicized, VHA medical facilities and veterans will remain
in doubt as to whether an adequate supply of pharmaceutical and biological
products will be available. FDA and the pharmaceutical and biological
trade aswciations can play key roles in helping VHA obtain thii
information and publicize the results in a single data clearinghouse.
In carrying out this assignment, we reviewed and analwed VA’s Y2K
documents and plans, comparing them against our guidance on Y2.K
activities. We also reviewed and analyzed FDA documentation relating to
its Y2K efforts on biomedical devices and pharmaceutical manufacturers.
In addition. we visited selected VHA medical centers. VA data centerS and
WA consolidated mail outpatient pharmacies to dis~oss their Y2K
activities, and interviewed VA and FDA officials on those activities. We
also interviewed ofiXals of the Emergency Care Research Institute
regarding their statements on biomedical equipment testing. Finally, we
interviewed selected private hospital oftXals about their Y2K actions and
GAO/AIMD-99-19OR Veterans Benefits and Health Care Services
Enclosure 1
GAO Testimony Dated April l&l999
pharmaceutical trade associations on their Y2K readiness surveys of
pham~aceuticalmanufacturers.
Mr. Chairman, thii concludes my statement. I would be pleased to respond
to any questions that you or other members of the Subcommittee may have
at this time.
Page 29 GAOIAIMD-99-190R Veterans Benefits and Health Care Services
Enclosure 1
GAO Testimony Dated April 15,1999
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Page 30 GAOIAIMD-99-190R Veterans Benefits and Health Care Servic
Enclosure 1
GAO Testimony Dated April l&l999
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Page 31 GAO/AIMD-99-19OR Veterans Benefits and Health Care Services
Enclosure 2
Comments From the DeDartment of Veterans Affairs
DEPARTMENT OF VETERANS AFFAIRS
ASSISTANT SECRIXARY FOR POLICY AND PLANNING
WASHINGTON DC 20420
JLN 3 1999
Mr. Gene Dodaro
Assistant Comptroller General
Accounting and Information Management Division
U. S. General Accounting Office
441 G Street, NW
Washington, DC 20548
Dear Mr. Dodaro:
This is in response to your draft report, YEAR 2000 COMPUTlNG CRISIS:
Actions Needed to Ensure Continued Delivery of Veterans Benefits and ffealfh
Care Services (GAO/AlMD-99-190). This report was based on the April 15. 1999,
Congressional Testimony on the readiness of the Department of Veterans Affairs (VA)
to deliver benefits and health care services through the turn of the century. While we
generally agree with GAO’s statement, we believe that additional perspective on VA’s
progress is warranted to assure stakeholder confidence in VA’s ability to continue
delivering services to our nation’s veterans and their beneficiaries.
In its testimony, GAO stated that forward-date systems acceptance testing on VA
computer platforms had not been completed. However, VA has conducted extensive
forward-date testing of our software applications. We view the testing that GAO is
concerned about as post-implementation testing. Post-implementation testing is the
additional step of actually moving the dates forward on our platforms to ensure that
commercial-off-the-shelf, vendor-certified compliant hardware and software will actually
work. Further, we required compliant products from manufacturers to forward-date test
our systems, and some of those products were not available at the time the applications
were corrected. The vendor has now provided those products, and VA is conducting
this additional post-implementation testing.
It is important to note that all VA applications, including those supporting benefits
delivery and health care, have completed the renovation, verification, and
implementation phases and are successfully processing Year 2000 dates today. In
addition, VA has completed the business contingency and continuity plans for benefits
delivery and health care. These are in place at each of VA’s regional offices and
medical facilities.
In addition, on April 21, 1999, the Veterans Health Administration (VHA) issued
Directive 99-016, Facility Review and Approval of Medical Devices for Year 2000
Compliance. This directive requires all facilities to document by June 1999, the
continued use and proposed disposition of medical devices that are not yet assessed or
Page 32 GAO/AI&ID-99-190RVeterans Benefits and Health Care Services
Enclosure 2
2. Mr. Gene Dodaro
that are assessed as non-compliant. In addition, all conditionally compliant medical
devices must be evaluated for disposition no later than September 1999. VHA has
assured GAO of its commitment to complete this review process and has kept GAO
apprised of its efforts in this regard.
We also share GAO’s concern that all of VA’s medical facilities and Consolidated
Mail Outpatient Pharmacies (CMOPs) are Y2K compliant. VHA designated the VISTA
(Veterans Health Information Systems Architecture) CMOP software application as
being mission-critical and has renovated and implemented that application per OMB
guidelines as of March 31, 1999. We have accelerated the schedule for the upgrade
and replacement of noncompliant vendor-supplied components of the CMOP
automated systems. We anticipate completing the upgrades and replacements by
August 1999. We will continue to work with FDA to ensure that all suppliers of
pharmaceutical and medical-surgical products are Y2K compliant and that all of our
medical facilities will have sufftcient inventories at the turn of the century.
The enclosure describes our actions taken and planned to implement your
recommendations. I appreciate the opportunity to review the draft of your report.
Enclosure
Page 33 GAO/AIMD-99-190R
Veterans Benefits and Health Care Services
Enclosure 2
Enclosure
DEPARTMENT OF VETERANS AFFAIRS COMMENTS TO
GAO DRAFT REPORT, YEAR 2000 COMPUTING CRISIS: Actions
Needed to Ensure Continued Deffvefy of Veterans Benefits
and Health Care Services
(GAOIAIMD-99-190)
Based on its April 15, 1999, testimony, GAO recommends that the Secretary of
Veterans Affairs ensure that the following specific actions are taken:
l Complete YZK testing of VBA and VHA mission-critical systems
including systems acceptance testing, full future-date testing, end-to-
end testing, and business process simulation testing on compliance
platforms
Concur - VA has completed the renovation, validation, and implementation phases as
defined by the Office of Management and Budget. As discussed in our cover letter,
GAO’s above recommended actions are identified as post-implementation testing and
are well underway. These actions will ensure that vendor-certified Y2K compliant
hardware and software will work correctly. The VBA’s Compensation and Pension
system has undergone forward-date testing. End-to-end testing with the Department of
Treasury began on May 17,1999, as scheduled. The business process simulation is
on schedule for the July 4”’weekend. VHA is completing the additional post-
implementation testing of its VISTA system, which is scheduled for completion by
September 1, 1999. It is important to note that all VA applications, including those
supporting benefits delivery and health care, are Y2K compliant and in production
successfully processing Year 2000 dates. In addition, VA has completed the business
continuity and contingency plans for benefits delivery and health care. These are in
place at each of VA’s regional offices and medical facilities.
l Set deadlines to complete assessment, renovation, validation, and
implementation of VHA facility systems
Concur - VHA is developing a policy directive for facility systems similar to the existing
policy for medical devices concerning the disposition of non-compliant devices. This
policy will require VA facilities to establish or identify a committee to review utility
systems’ components with an unknown or non-compliant Year 2000 status and
determine what action needs to be taken. Action includes replace, retire, or use-as-is.
The facility director must approve the proposed disposition of the device. The facility
systems policy will also require a documented plan of action for systems that are
identified as non-compliant or unknown by a specified completion date. We anticipate
completing this directive by July 31, 1999. In addition, the OMB defined phases of
assessment, renovation, validation and implementation do not apply to facility systems
as they do to software applications.
1
Page 34 GAO/AIMD-99-190R Veterans Benefits and Health Care Services
Enclosure 2
Enclosure
DEPARTMENT OF VETERANS AFFAIRS COMMENTS TO
GAO DRAFT REPORT, YEAR 2000 COMPUTING CRISIS: Actions
Needed to Ensure Continued Delivery of Veterans Benefits
and iiealfh Care Services
(GAOIAIMD-99-I 90)
(Continued)
l Develop business continuity and contingency plans for VHA ClVlOPs to
ensure an uninterrupted supply of medication to veterans in the event
of Y2K problems in these facilities;
Concur - VHA completed the business continuity and contingency plans for each of the
seven CMOPs by April 30,1999.
l Reassess VA’s decision to not report CNlOP systems as mission-
critical. Reporting these systems as mission-critical to VA top
management and OMB will help ensure that necessary attention is paid
to and action taken on them.
Concur in Princiole - As stated in the cover letter, we have accelerated the schedule for
the upgrade and replacement of noncompliant vendor-supplied components of the
CMOP automated systems. VVe anticipate completing the upgrades and replacements
by August 1999. VHA has completed the renovation, validation and implementation of
the mission-critical VISTA CMOP application. It is implemented as compliant. The
following functions in the VW-A CMOP application have always been identified as
mission-critical, and were tracked and reported to OMB as such:
Pharmacist order entry
Electronic transmission of prescription data to CMOP facility
Transfer of prescription data to the automated dispensing equipmeni
Return of release information to medical center files
Integration with Outpatient Pharmacy application
Automatic screening of prescriptions prior to transmission to the CMOP facility
Status tracking of prescriptions
Interface to prescription co-payment billing
Complete inventory control, order tracking and operational data for the CMOPs.
l Seek the assistance of the Food and Drug Administration and industry
trade associations to obtain information on the Y2K readiness of
specific pharmaceutical and medical-surgical suppliers who did not
respond to VHA’s survey to suppliers, and publicize the results in a
single data clearinghouse.
2
-
Palge 35 GAO/AIMD-99-190R Veterans Benefits and Health Care Services
Enclosure 2
Enclosure
DEPARTMENT OF VETERANS AFFAIRS COMMENTS TO
GAO DRAFT REPORT, YEAR 2000 COMPUTING CRISIS: Actions
Needed to Ensure Continued Delivery of Veterans Benefits
and Health Care Services
(GAO/AI MD-99-l 90)
(Continued)
Concur - VA is working with FDA and various industry associations to obtain and share
information on the Y2K readiness of specific pharmaceutical and medical-surgical
suppliers, especially those who have not responded to VA’s supplier survey. VA has
surveyed all of its VA pharmaceutical and medical-surgical suppliers in all aspects of
the Y2K issue. FDA is cognizant of all pharmaceutical and medical-surgical suppliers
doing business federally and publicly in the United States. VA results are published
and available on VA’s Homepage on the Internet (hti@/www.va.gov). We update this
information periodically. VA will continue to query industry and tiork hand-in-hand with
the FDA as their survey results become available. After June 30, 1999, VA will be
contacting all survey respondents to determine whether system remediation and testing
deadlines have been met as indicated.
3
Page 36 GAO/AIMD-99-190RVeterans Benefits and Health Care Services
Enclosure 3
GAO Contacts and Staff Acknowledgements
GAO Contact
Helen Lew, (202) 512-9396
Acknowledplements
In addition to the person named above, Nabajyoti Barkakati, Tonia Johnson,
Barbara Oliver, John Riley, and Michael Resser made key contributions to this
report.
Page 37 GAO/AIMD-99-190RVeterans Benefits and Health Care Services
Related GAO Products
Year 2000 Comnutinn Crisis: Readiness of Medicare and the Health Care Sector
(GAO/T-AIMD-99-160, April 27,1999).
Year 2000 Comnutinn Crisis: Kev Actions Remain to Ensure DeIiverv of Veterans
Benefits and HeaIth Services (GAO/T-AIMD-99-152,April 20,1999).
Year 2000 Comnutin~ Crisis: Leadershin Needed to Collect and Disseminate
Critical Biomedical Eauipment Information (GAO/T-AIMD-98-310, September 24,
1998).
Year 2000 Commuting Crisis: ComnIiance Status of Manv Biomedical Eauipment
Items Still Unknown (GAO/AIMD-98-240, September l&1998).
Year 2000 Commuting Crisis: Progress Made in Compliance of VA Svstems, But
Concerns Remain (GAO/AIMD-98-237, August 21,1998).
(511259)
Page 38 GAO/AIMD-99-190RVeterans Benefits and Health Care Services
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Address Correction Requested
Year 2000 Computing Crisis: Actions Needed to Ensure Continued Delivery of Veterans Benefits and Health Care Services
Published by the Government Accountability Office on 1999-06-11.
Below is a raw (and likely hideous) rendition of the original report. (PDF)