HEARING 2 ON YEAR 2000 COMPUfER COMPU· 

ANCE IN THE DEPARTMENT OF VETERANS 

AFFAIRS 

HEARING 

BEFORE THE 

SUBCOMMITTEE OVERSIGHT AND INVESTIGATIONS 

OF THE 

COMMITTEE ON VETERANS' AFFAIRS 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED FIFTH CONGRESS 

FIRST SESSION 

SEPl'EMBER 25, 1997 

Printed for the use of the Committee on Veterans' Affairs 

Serial No. 105-22 

u.s. GOVERNMENT PRINTING OFFICE 

WASHINGTON: 1998 

For sale by !be u.s. Government Printing Office 

SuperioIeDdenI of Documents, CoogJessionaI Sales Office, Wasbingtoo, DC 20402 

ISBN 0·16-056363·1 
COMMITTEE ON VETERANS' AFFAIRS 

BOB STUMP, Arizona, ChairnIGII 

CHRISTOPHER H. SMITH, New Jeraey LANE EVANS, Illinoia 

MICHAEL BILIRAKIS, Florida JOSEPH P. KENNEDY II, Mauachuaetta 

FLOYD SPENCE, South Carolina BOB FILNER, Calitomia 

TERRY EVERETI', Alabama LUIS V. GUTIERREZ, Illinoia 

STEVE BUYER, Indiana JAMES E. CLYBURN, South Carolina 

JACK QUINN, New York CORRINE BROWN, Florida 

SPENCER BACHUS, Alabama MICHAEL F. DOYLE, Pennaylvania 

CLIFF STEARNS, Florida FRANK MASCARA, Pennaylvania 

DAN SCHAEFER, Colorado COLLIN C. PETERSON, Minnesota 

JERRY MORAN, Kanaas JULIA CARSON, Indiana 

JOHN COOKSEY, Louiaiana SILVESTRE REYES, TeXllll 

ASA HUTCHINSON, Arkansas VIC SNYDER, Arkansas 

J.D. HAYWORTH, Arizona CIRO D. RODRIGUEZ, TeX811 

HELEN CHENOWETH, Idaho 

RAY LAHOOD, ILLINOIS 

CARL D. COMMENATOR, Chief Couruel and Staff Director 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS 

TERRY EVERETI', Alabama, Chairman 

BOB STUMP, Arizona 

FLOYD SPENCE, South Carolina 

STEVE BUYER, Indiana 

JAMES E. CLYBURN, South Carolina 

VIC SNYDER, Arkansas 

FRANK MASCARA, Pennsylvania 

(0) 
CONTENTS 

OPENING STATEMENTS 

Chairman Everett ................................................................................................... . Hon. Lane Evans, ranking democratic member, House Committee on Veterans' Affairs ........................................................................................................... . Hon. Frank Mascara ............................................................................................... . Hon. James E. Clyburn .......................................................................................... . 

WITNESSES 

Catlett, D. Mark, Acting Assistant Secretary for Management, Actin2 Chief 

Information Officer, Acting Chief Financial Officer, Department of \'eteran 

Aft'airaj accompanied bY' David R. AlbinBon CIO, Veterans Health Administration, Department of Veteran Affairsj and Newell E. Quinton, CIO, Veter- ans Benefits Administration, Department of Veteran Affairs ......................... . 

Sho~C!~~~D~t~ ~~i··~i~~··~f·Ei~~~··~d·C;;~p;i~; SCience, Office of Science and Techno o~, Center Cor Devices and Radiological H~~~ Food and Drug Administration ...................................................... . PrepBnlO statement of Mr. Shope .................................................................. . Willemaaen Joel C., Director, Information Reaourcea Management, Accounting and Information Division, General Accounting Office.i. accompanied by Helen Lew, Aaaistant Director, Information Reaourcea Management, Accounting and Information ~ment Division, General Accounting Office, 

and Leonard J. Latham, Technical Aaaistant Director, Office of the Chief 

Scientist, Accounting and Information Management Division, General Accounting Office ..................................................................................................... . Prepared statement of Mr. Willemaaen ......................................................... . 

MATERIAL SUBMITTED FOR THE RECORD 

Charta: 

VB:~ ~~mf~rC:;eD~l~~ .. ~~~~.~~.~.~~ Status of Medical Device Manufacturer Responses to VHA Industry Letter, submitted by DVA ................................................................................. . Written committee questions and their reBj)Onaes: 

Congreaaman Evans to Department ofVeterana Affairs ............................. . Congreaaman Evans to U.S. General Accounting Office ............. : ................ . Congreuman Evans to Food and Drug Administration, Department of 

Health and Human Services ....................................................................... . 

(m) 

1,24 

2 

28 

25 

8 

51 

19 

58 

2 

32 

14 

18 

65 

68 

70 

HEARING 2 ON YEAR 2000 COMPUTER COM· 

PLIANCE IN THE DEPARTMENT OF VETERANS AFFAIRS 

THURSDAY, SEPTEMBER 26, 1997 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, 

COMMITTEE ON VETERANS' AFFAIRS, 

Washington, DC. 

The subcommittee met, pursuant to notice, at 9:30 a.m., in room 

334, Cannon House Office Building, Hon. Terry Everett (chairman 

of the subcommittee) presiding. 

Present: Representatives Everett, Evans, and Mascara. 

Mr. EVERETT (presiding). The hearing will come to order. 

Good morning. This moming's hearing is a follow-up to the hearing the Subcommittee on Oversight and Investigations had on June 

26, on the V Ns efforts to achieve year 2000 computer compliance. Our last hearing emphasized the picture within Veterans Benefits 

Administration, VBA, and this hearing will emphasize the Veterans Health Administration, VHA, with an overview of the Depart- ment-wide activities. As some industry analyst predicted, the more 

the problem is examined, the bigger it appears to be. Cost estimates are rising remarkably and rapidly. 

I stated during the last hearing that time is running out. We 

again have a real-time computer display, this one new and improved with audio, counting down to the year 2000, which occurs 

here on the Internet. There are 828 calendar days left, not a lot 

of time for the amount of work that we have to do. 

Today, we will hear from the General Accounting Office which 

the subcommittee asked to look at-particularly at VHA. Also, of 

course, we hear again from the VA, and we'll hear again from the 

Federal Drug Administration on Y2K impacts on health care delivery and patient safety issues related to non-compliance medical devices and equipment. 

I look forward to having the hearing. At the outset, let me also 

thank our full committee ranking member, who will take over the 

Chair of this hearing. I regret, unfortunately sometimes we serve 

on more than one committee and I have a bill that I have to introduce in another committee, and our ranking member is not feeling well today and sends his apologies for not being here. 

I appreciate the witnesses turning uf' and I'll look forward to reviewing your testimony. At this time would ask Lane Evans-as 

I said, our ranking full committee chairman, and who is no stranger to this seat also-to take over. His interests and my interests 

(1) 
2 

have :parallel on this particular problem for a number of years. So, 

Lane if you'll take over, I'd appreciate it. 

OPENING STATEMENT OF HON. LANE EVANS, RANKING DEMOCRATIC MEMBER, HOUSE COMMITTEE ON VETERANS' 

AFFAIRS 

Mr. EVANS. I am very pleased that Chairman Evans has scheduled this all-important follow-up to this summer's hearing on the 

VA's efforts to achieve year 2000 compliance. In June, the GAO 

told us that the VA has a long way to ~o to solve this problem, but 

not much time to get there. Time obVlously doesn't stand still, at 

least not in this life, so we've got to do all we can on the committee 

to ensure that the VA is able to provide high-quality, non-interrupted service to our veterans once the clock turns over to the next 

millennium. 

I am encouraged that the subcommittee continues to carefully monitor the VA's progress on this issue. I am particularly pleased 

with the steps that the Veterans Benefits Administration has taken 

to bolster the management of its year 2000 compliance efforts, and 

I am hopeful that the Veterans Health AdminIstration will make 

similar progress in the days and weeks to come. Still there is no 

doubt that the VA has a daunting management task ahead of itself 

if it is to meet the year 2000 goals. 

I believe I also speak for the chairman when I say that this subcommittee stands ready to continue its aggressive oversight on this 

issue so that the VA will be in the best possible position to ensure 

that it brings its mission-critical systems into year 2000 compliance. 

Again, I want to thank Chairman Everett for his continued leadership, and I look forward to today's testimony. 

Mr. EVERETT. At this time I would like to have recognition for 

panel number one: Joel Willemssen, Director, Information Resources Management, Accounting and Information Management Division of the GAO, and ask him to introduce his colleagues. 

STATEMENT OF JOEL C. WILLEMSSEN, DmECTOR, INFORMATION RESOURCES MANAGEMENT, ACCOUNTING AND INFORMATION DMSION, GENERAL ACCOUNTING OFFICE; ACCOM· 

PANIED BY HELEN LEW, ASSISTANT DmECTOR, INFORMA· 

T10N RESOURCES MANAGEMENT, ACCOUNTING AND INFORMATION MANAGEMENT DMSION, GENERAL ACCOUNTING 

OFFICE, AND LEONARD J. LATHAM, TECHNICAL ASSISTANT 

DmECTOR, OFFICE OF THE CHIEF SCIENTIST, ACCOUNTING 

AND INFORMATION MANAGEMENT DMSION, GENERAL AC· 

COUNTING OFFICE 

Mr. WILLEMSSEN. Thank you, Mr. Chairman. Accompanying me 

today is Helen Lew, Assistant Director, and L.J. Latham, Technical 

Assistant Director. 

Thank you for inviting us here today to testify on the progress being made by the Federal Government, and in particular VA, in 

addressing the rear 2000 computing challenge. As requested, I will 

briefly summanze my statement. 

Regarding the Federal Government's overall efforts to address 

the year 2000 issue, the progress of many of the major agencies 
3 

continues to be too slow. Seventy-five percent of the agencies' total 

number of 8,500 mission-critical systems still need to be repaired 

or replaced, and the total cost estimate has now increased to $3.8 

billion up about $1 billion from the estimate of 3 months ago. 

Reports of several of the agencies are disappointing, and therefore, OMB is now placing more urgency on this issue and beginning 

to demand evidence of progress. 

Turning to the VA, it's critical that the Department's systems be 

made year 2000 compliant to avoid disruption to benefits and services. Our past and current work at VA mdicates that the Department recognizes the urgency of its task, and it has made progress. 

But much remains to be done if it is to avoid wide-spread computer 

failures. If left uncorrected, the types of possible problems that 

could occur include: late or inaccurate benefits' payments, lack of 

patient scheduling for hospital treatments, and misinterpretation 

of patient data. 

As we testified in June, VBA has responded to the challenge by 

initiating a number of actions. However, several risks remain. 

These include: schedules for the renovations of key applications 

such as compensation and pension being compressed and other renovations schedules being very tight. In addition, although VBA has 

comeleted an inventory of its internal and external data-interfaces, 

it still has not assessed the m~ority of these for year 2000 compliance. If VBA is to avert serious disruption, it will need to address 

issues such as these. 

The year 2000 challenge for the health side of VA is enormous. 

VHA is in the initial stages of assessing the compliance of its mission critical systems. It does not plan to complete assessment until 

January 1998, and renovations until July 1998. To effectively assess and renovate, it is necessary to understand how local facilities 

are using National applications. If it is true that some local facilities have customized these National applications, it's important 

that VHA know where these applications have been changed so as 

to ensure that they also are year 2000 compliant. 

Physical facilities are another area of concern. VHA has not yet 

completed an inventory of facilities' related systems and equipment 

such as: ventilating systems, securitY, systems, and disaster recovery systems. Such elements are VItal to providing health care 

services. 

Biomedical devices could also be affected by the year 2000. The 

impact could range from incorrect formatting of a print-out to incorrect operation of the device, having a potential to affect patient 

care or safety. In attempting to precisely determine this unpact, 

VHA has sent letters to manufacturers. Based on the responses received from its first letter, VHA recently sent more detailed letters 

asking more specific questions. These letters were sent to about 

1,600 manufacturers on September 9, with a request for a response 

by October 3. 

FDA, in its role of protecting the public from unsafe or ineffective 

medical devices, also recently began communicating with manufacturers. FDA sent a letter in early July of this year to about 13,000 

such manufacturers reminding them of their responsibility to ensure that their products will not be affected by the century change. 

According to FDA, one response was received to this letter. An 
4 

FDA official explained that it was not the agency's intention to solicit a specific response because FDA expects manufacturers to report any problems through normal reporting channels. 

That concludes a summary of my statement, and I'd be pleased 

to address any questions that ;rou may have Ranking Member 

Evans or Congressman Mascara. Thank. you. 

[The prepared statement of Mr. Willemssen appears on p. 32.] 

Mr. EvANS (presiding). Thank. you very much. We appreciate 

your testimony. The Office of Management and Budget places the 

VA in the upper-half of Federal agencies as far as year 2000 compliance efforts are concerned. Would you agree with this assessment? 

Mr. WILLEMSSEN. I have a fairly good idea on the pro~ess of the 

other agencies and I would say, especially in terms of Its recognition of the urgency of the issue, its commitment to make it a top 

priority, and its devotion to put the necessary resources towards it, 

VA would definitely be in the u:pper half of the 24 major departments and agencies at this point m time. 

Mr. EVANS. How realistic is the VA's $162 million budget estimate for its year 2000 compliance efforts? 

Mr. WILLEMSSEN. At this point, it's the best we have. Frankly, 

I would anticipate that you will see it gradually escalate over the 

next several months as the assessment of VHA is completed. It 

may not necessarily escalate, but that would be our best estimate 

at this point. 

Mr. EVANS. As you indicated, we've seen a $1 billion increase in 

OMB's estimate for Government-wide Year 2000 operations in the 

last 3 months or so, up to $3.8 billion. Is that something we can 

expect as well? 

Mr. WILLEMSSEN. Yes, sir. Until full assessments are done at all 

the major agencies you can still expect some gradual increases in 

all likelihood. 

Mr. EVANS. I think almost everyone agrees with the view that 

the year 2000 compliance problem represents management rather 

than technical challenges to Federal agencies. Would you agree 

with such an assessment, and if so, could you specify what additional steps VA must take to adequately address these management issues? 

Mr. WILLEMSSEN. We would definitely agree that the challenge 

is more managerial than technical. Regarding VHA, it's absolutely 

crucial to complete, from a management perspective, their assessment and renovation activities as soon as possible. As they begin 

collecting more information on the health side, including biomedical devices, it is especially important that they disseminate 

that information as widely as possible so that every one knows 

exactly what they and others are finding in terms of the compliance of their systems and various medical devices. I think there is 

also an open question for both the VHA and, more importantly 

FDA, on the extent to which they may decide to independently assess manufacturer claims that various devices are indeed year 2000 

90mpliant. 

!. Mr. EVANS. The VA's testimony in June suggested that this prob-

.em was not nearly as severe at the Veterans Health Admimstra- ~on as it is at the Veterans Benefits Administration. Your testi-
5 

mony suggests, however, that enormous challenges remain at VHA. 

Are you satisfied with the steps the VA has taken to address these 

problems? And how would you compare VHA's efforts to those of 

VBA's? , Mr. WILLEMSSEN. I'd say that VHA and VA recognize the enormous challenge they face, but frankly, looking at the statistics, 

VHA is obvi~:~k a little behind its counterpart on the benefits 

side. And, I . before we can say exactly what the magnitude 

of the problem is, VHA has to get through the assessment phase 

as quickly as possible. 

One of the concerns that we have, and we mention it in our 

statement, is the extent to which individual hospitals and other facilities have customized National applications software. To the extent that this has happened to a wide degree, it is going to be incumbent on VA to go out and check each of those facilities to make 

sure they are year 2000 compliant. But whether that is the case 

right now or not, I don't think anyone fully knows until that assessment has been completed. 

Mr. EVANS. The Veterans Health Administration has sent several 

letters to manufacturers of medical devices that may not be year 

2000 compliant. VHA also intends to rely on the Food and Drug 

Administration to seek similar feedback from manufacturers in 

order to better gauge the health and safety risks if certain devices 

are non-compliant. Is this all the VA can do at this point to address 

the medical device safety issue? And what would be additional 

steps you would recommend for the VA and the FDA in this 

re2'8rd? 

Mr. WILLEMSSEN. On the medical device area, I would i3lll"number one: it is especially critical that whatever activities VHA has 

engaged in, that they widely disseminate the data that they are 

collecting to all affected parties so that everyone knows what the 

manufacturers' claims are. And then secondly, as I mentioned before, I think VHA and FDA have to think about next steps after 

they've received all the manufacturers' claims about their products; 

is there going to be some kind of independent assessment of whether those claims are in fact true. As you know, we have just recently 

begun our assessment at VHA, and that's an issue that we plan to 

explore further. 

Mr . EVANS. At this point I yield to the maJority counsel. 

Mr. Kingston SMITH. Thank you, Mr. Chamnan. 

Mr. Willemssen, at this point, what does GAO believe are the top 

three issues that Veterans Benefits Administration must aggres- sively address regarding the year 2000 compliance problem? 

Mr. WILLEMSSEN. On the benefits side, the top three would probably be: first, regarding the tight and compressed schedules for various key applications, there must be urgent mana~ement attention 

to the progress in actually renovating those applications to make 

sure that the schedule is met. And to the extent that the schedule 

starts slipping more, VA management will have to look at other op- tions since we can not have a slip in the schedule. 

Secondly, regarding data exchanges and interfaces, we think it is 

especially critical that they be assessed for compliance as quickly 

as possible. To VBA's credit, they have identified about 590 interfaces, but now the next important step is to assess whether those 
6 

interfaces are compliant; and to the extent that VA can't get the 

cooperation from other external entities, it needs to raise those issues as quickly as possible. 

And third, we would say it's fairly critical that VBA consider updating the risk assessment that it did earlier this year to take into 

account its revised strategy in its year 2000 program. 

Mr. Kingston SMITH. Thank you, Mr. Chairman. 

Mr. EVANS. The gentleman from Pennsylvania. 

Mr. MAsCARA. Thank you very much, Mr. Evans. 

I have an opening statement I'd like to include in the record. 

Mr. EVANS. Without objection, Frank, it will be entered in the 

record for this proceeding. 

[The prepared statement of Congressman Mascara appears on p. 

28.] 

Mr. MAsCARA. I had an opportunity to read over some of the 

statements last night; and is the problem with the VA unique some 

how, or does this transcend the VA across the entire governmentthe problem of 2000 compliance? 

Mr. WILLEMSSEN. The problem transcends the Federal Government. 

Mr. MAsCARA. Do you think perhaps the President or the administration or the Congress should appoint some kind of czar who 

would be in charge of a coordinated effort to solve the problem? I 

mean, as I see, and from what I read, you said that the budget, 

"The Office of Management and Budget has determined the VA is 

making much more progress than many other agencies." So each 

agency is dealing with the 2000 problem? 

Mr. WILLEMSSEN. That's correct, Congressman. 

Mr. MAsCARA. Do you believe that perhaps some concerted effort 

by the administration or the Congress to appoint some czar to deal 

with this problem would be to our benefit and maybe we would 

solve the problem before we get to the year 2000? 

Mr. WILLEMSSEN. We are on record in testimony in July stating 

that we thought OMB's actions to date at that time had been insufficient and that more urgency needed to be placed on this issue 

than has been. Frankly, though, we're encouraged by the most recent report of OMB that they are taking this issue more seriously; 

that they are urging more corrective action; and that, in some cases 

for certain agencies who clearly haven't made as much progress for 

their information technology acquisitions, OMB will not necessarily 

fund those acquisitions unless they are for year 2000 activities. So, 

I think the bar has been raised as we speak today, even compared 

to a couple of months ago. 

Mr. MAsCARA. How long have you been trying to solve this problem; or someone recognized we had a problem and thought we 

should do something about it? What timeframe? 

Mr. WILLEMSSEN. The broad recognition of this being a clear 

Government-wide and National problem; it's probably best to say 

about Spring 1996 is when it really started to begin to get attention. However, at the same time, I would say that people who program for a living have known that this would eventually hit all 

along, but when they were programming many of these systems, 

15, 20, 25 years ago, they had no idea they would still be around 
7 

as we approach the year 2000, and that's what in many cases has 

occurred. 

Mr. MAsCARA. The reason I ask that question, I'm curious because I was a county commissioner in Washington County and 

under our administration we computerized the county and talked 

about the year 2000. But even before that, as an accountant who 

computerized his offices back in the late 1960s and 1970s, we knew 

there was a problem then. And I'm just wondering why 1996, it 

took somebody--

Mr. WILLEMSSEN. I think that's when it really started to get a 

lot of attention. Beyond, I'd say even a year ago, the individuals 

who are not familiar with computer technology thought that this 

was still some sort of a scam by the information technology community to acquire additional funds. There was a denial phase that 

many had to go through. I think we're beyond that now. 

Mr. MAsCARA. How about cost? I read some figures, and I think 

the last time we had a hearing someone said that it was in excess 

of $300 billion worldwide in costs to solve this problem. Is there an 

estimate of what it's going to cost this government to solve the 

problem? 

Mr. WILLEMSSEN. The most recent estimate for the 24 major Federal agencies is $3.8 billion. That estimate does not include the cost 

of fixing various State systems which also are frequently helped 

with Federal funds. It does not include, obviously, the costs of 

many of the private sector firms that are going to have to make 

these fixes in order to minimize the economic impact to the 

country. 

Mr. MAsCARA. It seems to me, this is a National emergency. If 

we can't generate the checks for the GI bill, or health benefits, or 

VA pensions, and Social Security checks, and across the board, isn't 

this some kind of National emergency problem that someone should 

step forward and say, "Hey, we have a national emergency here. 

If we don't solve the Pl"oblem there's going to be chaos?" 

Mr. WILLEMSSEN. We have been tryin~ to sound that message. 

The year 2000 issue is one of GAO's high-risk areas within the 

Federal Government that we try to focus attention on and sound 

the alarm on. 

Mr. MAsCARA. Well then I guess its true that we work best under 

crisis, so it's not a crisis yet. We'll wait until 1999 and get into November and December and say, "We have a real serious problem," 

and malbe we'll solve it. 

I don t mean to be cynical, Lane, but someone needs to tell me 

something-I'm not a computer expert, I don't understand it, at 

best I'd say let's go back to 1900 and say that that means 2000 and 

just go forward, if it will accept 1900; I'm not sure if that's the case 

or not. But someone needs to make a concerted effort, and I don't 

think all these agencies should be out there running around spending money trying to figure out how we're going to solve it. If one 

person solved it, would it be across the board that all agencies 

could use that technology to solve the problem? 

Mr. WILLEMSSEN. No. The difficultyMr. MAsCARA. It is unique in certain circumstances? 

Mr. WILLEMSSEN. Yes, the computing environments are so heterogeneous that there is no single solution. You've got to go into 
8 

each individual system and you're not dealing just with applications, you're also dealing with operating systems, databases, telecommunications; so it is something you have to go in-and that's 

why we said earlier, it's not so much a technical challenge, it's a 

management challenge. It's a lot of tedious work to go in and analyze all that code. 

Mr. MAscARA. Are we hiring outside firms to come in and assist 

the government in solving these problems? 

Mr. WILLEMSSEN. Many of our agencies are hiring outside firms 

to help, and I think VA could also attest to that, that they are trying to get outside help also. 

Mr. MAscARA. Thank you. 

Mr. EvANS. Thank you; I appreciate your participation in the 

hearing today. 

We want to thank the GAO for their testimony and excellent response to our questions. We may have some follow-up from members that aren't here, and we'1l ask that you respond to those in 

writing and the questions and answers will be made part of the 

record of this proceeding. 

Mr. WILLEMSSEN. Thank you. 

Mr. EVANS. Thank you. At this time, we would like to welcome 

Mr. Mark Catlett, the VA's Actin~ Assistant Secretary for Management, the Acting Chief Information Officer, and the Acting Chief 

Finance Officer, and ask him to introduce his staff appearing with 

him today. 

STATEMENT OF D. MARK CATLETT, ACTING ASSISTANT SEC· 

RETARY FOR MANAGEMENT, ACTING CIDEF INFORMATION 

OFFICER, ACTING CIDEF FINANCIAL OFFICER, DEPART· 

MENT OF VETERAN AFFAIRS; ACCOMPANIED BY DAVID R. 

ALBINSON, CIO, VETERANS HEALTH ADMINISTRATION, DE· 

PARTMENT OF VETERAN AFFAIRS; AND NEWELL E. 

QUINTON, CIO, VETERANS BENEFITS ADMINISTRATION, DE· 

PARTMENT OF VETERAN AFFAIRS 

Mr. CATLETl'. Good morning, Mr. Chairman. 

Mr. EVANS. Good morning. 

Mr. CATLETl'. Accompanying me today are Mr. Dave Albinson, 

the Chief Information Officer for the Veterans Health Administration; and Mr. Newell Quinton, the Chief Information Officer for the 

Veterans Benefits Administration. 

Would you like me to go ahead with my full statement? . Mr. EvANS. Please, if you would at this time. 

Mr. CATLETl'. Mr. Chairman and members of the subcommittee, 

it is my pleasure to testify on behalf of the Department of Veteran 

Affairs on the status of our information systems for the year 2000. 

I am accompanied today by the gentlemen I just mentioned. We 

last met with you on June 26, and today we wish to give you an 

update on our progress. I have submitted my full statement to the 

subcommittee, which I ask to be made a part of the hearing record. 

I would like to take this opportunity to provide the subcommittee 

with an update on VHA's, VBA's, and the Austin Automation Center's year 2000 accomplishments. 

For the Veterans Health Administration: VHA has prepared and 

widely distributed a detailed compliance plan, organized in accord-
9 

ance with the GAO's draft year 2000 best practices. We provided 

a copy of that plan to the subcommittee in June. In the ]llan, key 

responsibilities and accountability were assigned to the VIlA CIO 

and associate CIOs; the Veterans Integrated Service Network 

CIOs, the 22 people there at the networks; and VIlA health care 

facility management. 

VIlA's goal is to complete its assessment, including the nationwide assessment of biomedical equipment at all VA medical centers 

by January 1998. VIlA's plan is to complete any necessary renovation by July of 1998, validation by January of 1999, and implemen- tation by October of 1999. 

As of August 31, 1997, 30 percent of VIlA's mission-critical applications are compliant. This percentage represents both the VISTA, 

which used to be DHCP, and the VHA corporate system applications. I would add that the definition of compliance is the fact that 

includes those applications that are intended to be retired, as defined by OMB. 

VHA has assigned priorities to and scheduled the renovation of 

VHA mission-critical systems. VISTA information system applications have been categorized according to their criticality to VHA's 

mission. To support the detailed VISTA application assessment 

process, VHA has acquired and is using an automated tool to support code analysis for both the National software applications and 

for locally developed software applications. VHA has begun to use 

this tool on some of its larger, more complex applications; code that 

will require renovation appears to be limited. As of August 31, 

1997, 31 percent of VISTA applications have been assessed and 27 

percent of VISTA applications are compliant or will be eliminated 

by the year 2000. 

VHA is currently assessing all of its corporate information systems. System owners have been asked to determine the compliance 

status of their systems and to establish schedules for completing 

the process if the systems are non-compliant. To date, 37 percent 

of the corporate systems have been assessed, 33 percent are either 

already compliant or, again, will be eliminated by the year 2000. 

VHA has completed its inventory of commercial-off-the-shelf 

products for each hospital and has begun to determine the compliance of these products. 

For biomedical equipment, as we testified in June, the potential 

year 2000 impact on biomedical equipment is a National issue, 

clearly, affecting both the private sector and Federal health care 

communities. VA, along with other agencies and the private health 

care community, is a consumer of biomedical equipment; we do not 

regulate the industry. Let me bring the subcommittee up to date 

on the specific actions VA is taking in the area of biomedical 

equipment. 

VIlA formed the Medical Devices Integrated Product Team, a 

multi-disciplinary oversight committee within VHA, to assist with 

identifying, inventorying, assessing, and evaluating medical devices 

at risk. 

A subcommittee of this team created a database listing manufacturers of medical devices currently in use in VHA. Experts from 

the team were consulted to ensure that manufacturers in all "soocialty areas were included. A letter requesting more detailed infor-
10 

mation and plans from biomedical manufacturers was sent on September 10 to all 1,580 manufacturers in the database. Vendors 

were asked to respond by October 3; thus far, 135 responses have 

been received. VHA is reviewing these responses and will share the 

results with the Food and Drug Administration. 

For VBA: significant progress on year 2000 efforts has been 

made in recent months. As of August 31, 1997,52 percent ofVBA's 

applications have been renovated and made year 2000 compliant. 

Two payment applications, Chapter 31, the Vocational Rehabilitation Program; and a small one, the Reinstated Program for Survivors are compliant. Our insurance application is on schedule with 

its renovation and will begin testing in February of 1998. 

We testified in June that we awarded a task order for oversight 

support. The oversight team completed their assessment of VBA's 

year 2000 effort. Their assessment substantiates the attention VBA 

has given this issue. VBA's year 2000 effort is on track and its 

schedules and resources are realistic. The oversight team has made 

suggestions and recommendations that are being incorporated into 

VBA's year 2000 project plan. 

Overall, education system milestones are on track for completion 

within the projected timeframes and well before any application 

fail date. However, the project completion date provided by our contractor shows a slippage for the Chapter 1606 redesign component 

of the education system. This slippage has not jeopardized our 

overall completion date for making education systems compliant. 

As for loan guaranty applications, task orders have been awarded, and will be awarded, to renovate non-compliant applications ensuring that all loan guaranty applications are compliant by the projected timeframes and before any fail date. 

VBA is developing a new application for real-estate property 

management. That schedule has slipped, but that will not impact 

the year 2000 schedule because the existing application is already 

compliant. 

Let me address the compensation and pension application and its 

status. Forty-six percent of compensation and pension modules are 

year 2000 compliant. However, year 2000 work is competing with 

legislative program changes for spina bifida and incorporating Minimum Income for Widows, plus preparing for the annual cost of living adjustments. To minimize the risk that the complexities of implementing legislative changes would jeopardize year 2000 efforts, 

VBA awarded a contract, very recently, for renovation support of 

our compensation and pension application. This contract provides 

an automated year 2000 conversion tool for the application and additional contract support. 

The oversight team that we've mentioned, that we've formed, 

both with a contract and some of our folks, has identified C&P as 

our highest risk in VBA in the year 2000. Managing the contract 

and developing detailed plans for applications testing to be done by 

the VBA staff in Hines, IL need to be improved. We agree with the 

team's assessment and are taking action to meet this need. 

VBA has addressed all areas of potential year 2000 problems. 

They have assessed all of their third party products and have budgeted for their replacements. In addition, VBA is working hard to 
11 

resolve interface issues. Forty percent of their interfaces are year 

2000 compliant as of today. 

At the Austin Automation Center, we provide VA-wide information technology support for all components of the Department. As 

of August 31, 1997, 79 percent of the applications they support 

have been renovated and are year 2000 compliant. The AAC, as I 

call the Austin Automation Center, plan is to have all systems renovated by September of 1998, validated by October of 1998, and 

fully implementec!]>y September of 1999. 

VA, VBA, and VHA representatives are actively involved in several interagency efforts to find common solutions to year 2000 issues and are representing VA's interest in several subgroups of the 

Federal CIO Council Subcommittee on the year 2000. Included are: 

the biomedical equipment, telecommunications, and building systems subgroups. 

In summary, Mr. Chairman, VA, organizations have prepared detailed systems inventories; and developed testing methodologies, individual project plans, and contingencies. We are monitoring our 

progress for each application supporting our mission-critical systems. We are also monitoring such key elements as estimated linesof-code, number of modules, operating systems and COTS 

packages. 

We are committed to ensuring VA's information systems will provide uninterrupted service supporting the full range of veterans 

benefits delivery and medical care for the year 2000 and beyond. 

I thank you for this opportunity to present our progress on the year 

2000. Mr. Albinson, Mr. Quinton and I would be happy to answer 

anLof your questions. Thank you very much. 

[The prepared statement of Mr. Catlett appears on p. 51.] 

Mr. EVANS. Thank you, Mr. Catlett. The GAO and your outside oversi~ht team, have strongly indicated that better management is 

essential to year 2000 compliance. What additional steps will you 

be taking to solidify year 2000 man~ement efforts? 

Mr. CATLETT. Mr. Chairman, I think the steps that we are now 

taking are sufficient; and I say that in this way: we meet monthly 

with these two ~entlemen and their staffs to review progress, to 

look at the tracking that's going on. 

I'll raise an issue that you mentioned earlier. You noted that we 

had identified 11 mission-critical systems, and there was a concern-a legitimate concern-raised by you that that may be too 

few, when there were other departments that listed hundreds. But, 

within those 11 systems we have over 500 applications. And we 

have people on my staff and on these two gentlemen's staffs that 

are looking at those daily to track them. Frankly, we use the 11 

systems to make it easier for you and for me to look at and give 

you a broad overview of what our progress is in terms of dealing 

with all the complexities and a wide variety of applications that we 

deal with. 

So again, I'd say that, as we have attention brought to us both 

by GAO and our own contractors that we're hiring to identify problems in the schedules that we have developed, we'll react to those 

within this framework that we've set up. 

One thing I would add, again it's nothing new based on this GAO 

report-the GAO has been very helpful in the things they have 
12 

identified, but as we did last rear we will have an independent assessment of our efforts again m the December to March timeframe. 

Actually, I would like to have it a little sooner, but we're going to 

wait for the VHA assessment to be completed and then we're going 

to have an independent contractor come in and look at what we're 

saying both in those plans and also the work that's been identified 

as completed, both in VHA and VBA, and at the Austin Automation Center. 

So, we understand the urgency, we understand it's a lot of work 

and we're putting forth a ~ood effort and we'll continue that and 

certainly intensify it as indications come, both from ourselves, from 

our contractors, and from GAO. 

Mr. EvANS. During your testimony in June you downplayed the 

seriousness of the problem within the Veterans Health Administration. Do you still have that same level of optimism with regard to 

the year 2000 challenges faced by VHA. 

Mr. CATLE'M'. I'm going to quibble with your words there in 

terms of "downplaying." We have a schedule. I still define the prob- lem of VHA as one that's broad but not very deep. As we know, 

the size of that system and the number of applications and the 

number of specific activities out there are numerous, huge in number. And, we have to look at all of those. VHA is on the schedule 

that they had projected and we had submitted to you in June; and 

as I said, I'm sure, that as we have had with VBA to date, we'll 

find areas where we will have to intensify our effort. I think the 

resources are there within VHA to do that, both in terms of the 

personnel that will be needed to do it and the dollars that will be 

necessary to do that. 

The one thing I would add, is that in terms of biomedical equipment, 1999 is the year of concern for me for biomedical. In terms 

of systems work, that has to be underway now; and particularly through 1998. For biomedical equipment, it's largely going to be 

funding, if its non-compliant, the replacement of that equipment. 

We at this point, don't expect that to be a huge number. But we 

will want to have that information in time to make an adjustment 

to our 1999 budget request, if necessary, for biomedical equipment. 

Mr. EvANS. Because of a pending vote, I'd like to yield to the gen- tleman from Pennsylvania, in case he might not be able to make 

it back. If there are any questions? 

Mr. MAsCARA. My question is, deals with the possibility of not 

solving the problem entirely, and what could happen then. Do you 

have a back-up plan? If all else fails, the worst possible scenario 

not being able to solve the problem. entirely by the year 2000? 

Mr. CATLETl'. Well, Mr. Congressman, as GAO noted, there are 

a lot of negative consequences for not getting it done. We will-we 

do have plans, and as GAO says, we need to update our risk assessment, which we agree with and will do. But, I don't believe this 

is an issue of not getting the checks out. We could be late getting 

the check out; we may ~et the wrong amount out; and that's a 

problem, I'm not minimizmg that. But it is not a question of veterans not getting paid. If we have to do it by paper and pencil, we'll 

do it. But again we don't think that we're in that mode of a crisis. 

I agree with some of the things that you had to say in the sense 

that this is a huge problem. But again, we think we're on top of 
13 

it, and fully expect in that there will be problems that come up 

that we haven't anticipated; but we think we have the resource levels required. Much of the resources we need, we already have. It's 

not a question of getting contractor help for the first time, as VBA 

already has. But a lot of the work in VHA that's going to be required, will be done by their own staff. It's a matter of making sure 

within the staff that deals with information technology systems, 

that they get a focus. And, Mr. Albinson has it under way. And I'm 

very confident that we are paying attention to this and trackintf 

this monthly so that when problems do arise, as they will, we wi 

respond quickly. Our cost estimates will probably go up, but we are 

a very, very tiny part of that billion dollar increase that's been 

talked about here today; I want that on the record. We've increased 

our estimate by $18 million on a base of $144 million over this 

three year period. I expect that they will go again. 

And as I said in June, in biomedical equipment, we haven't estimated the impact there. We expect it not to be large; but not to 

be large is in the sense of a $17 billion a year operation that the 

health care system is. So we will be seeing our prices go up as we 

get the information on biomedical that we expect. 

So, again, we are tracking the problem, we are watching the 

problem, and as issues rise that we haven't anticipated, I am confident that we have the resources to address those. 

Mr. MAsCARA. Thank you, Mr. Catlett. Thank you, Mr. Chairman. 

Mr. EVANS. Thank you. We're going to go to recess now because 

of a pending vote which may be followed by another vote, as I understand it. So, we're going to recess and try to get back by about 

10:30 or so. 

Mr. CATLETl'. Sure, Mr. Chairman, we'll be here. 

Mr. EVANS. We'll recess at this time. 

[Recess.] 

Mr . EVANS. The hearing will now resume, and we'll yield to majority counsel. 

Mr. Kingston SMITH. Thank you. 

Mr. Catlett, the VA has some significant computer interfaces 

with other agencies and departments of the Federal Government. 

What are those interfaces, and what is the status of Y2K compliance for those interfaces? 

Mr. CATLETl'. I'm going to ask Mr. Quinton to give you some information on that, and we'll probablr. need to provide some specifically for the record, to get more detailed information on it. 

(Subsequently, the Department of Veterans Affairs provided the 

following information:) 
VBA Year 2000 External I

VBA Year 2000 Project Office A profile of VBA External Interfa

Interface Partner Hines Austin Philadelp

VA Entities 133 195 9 

DOD 40 18 12 

Treasury 43 0 4 

Dept. of Labor 43 0 0 

Internal Revenue 4 22 0 

Social Security 10 0 3 

CreditIBanks/Ins. Cos 7 28 0 

Colleges/CongressN ets 0 23 0 
15 

Mr. CATLETl'. But, as you noted or implied, clearly, with the 

major departments and agencies throughout the government, we 

have a lot of interfaces as we move payments and move information back and forth. The one I'm most concerned about now is the 

Department of Treasury. I've had preliminary discussions with the 

CIO there. We have met. We have a list of the interfaces with 

Treasury that affects primarily our payments to veterans, which is 

the first focus that we all have. We'll be meeting with them soon 

at a staff level;.-mcluding the Financial Management Service, FMS, 

as they call it, and their CIO. We will review our roles and respon- sibilities and reach agreement on the list of interfaces. 

And as I said, Mr. Quinton's office has put together a comprehensive list of the interfaces that VBA has with Treasury. We have 

done some work at our Austin Automation Center for the same 

thing, and we will be meeting with them in the next several weeks. 

Mr. QUINTON. Sir, our inventory of interfaces shows a total of 

731, and that includes interfaces to all of our mission-critical systems at our Hines facility, Philadelphia and Austin. Of the 731, 

342 involve the Hines Data Processing Center and reflect the interfaces which provide information to or from our payments system. 

I think it is Important to note, when we speak of interfaces, a sig- nificant amount of these are for information and are not paymentrelated. 

As we said earlier this morning, 40 percent of those interfaces 

are compliant; 33 percent are not compliant, and our approach 

right now is to continue to look at every single interface to make 

a determination of whether it involves a date field and then to get 

it resolved. A significant percentage of the 731 interfaces are internal to VA, as opposed to sharing information with other Federal 

agencies, as Mr. Catlett indicated. 

Another effort that we will take with interfaces is to separate those that result in the generation or execution of a payment from 

those that would involve information for report purposes. This will 

provide a focus for us to address the ~ayment issues first. 

Mr. Kingston SMITH. Thank you. It's our understanding that the 

VA is planning to take $5 million from VETSNET funding to help 

fund the increased financial requirements of the year 2000 compliance. Is that correct? 

Mr. CATLETl'. I'm glad you raised the question. We had a hearing 

last week on GPRA, and that issue came up as a side item. As we 

discussed with you, this committee, over this past year, we've made 

the commitment; the Deputy Secretary and now the Secretary-designate made the commitment that, if we have a funding need for 

year 2000 purposes, that is more than other sources can produce, 

we would use our VETSNET money. But that's different than what 

folks are looking at now in terms of an Appropriations Committee 

report, a Senate report, that said, shift that $5 million. The $5 million I think you're referring to is in a Senate Appropriations subcommittee. report that says, for 1998, to move the VETSNET 

money. I think they've reached that conclusion, based in part at 

least on the NAPA report. 

We have e~ressed our opinion that it's important to move forward with VETSNET. We understand the concerns about the timing and the schedule for VETSNET, but, nonetheless, we support 
16 

the VETSNET effort, and will continue to move with that. So, as 

I said, the distinction is we may have to take some money off 

VETSNET for year 2000. As stated last spring, we're still committed to that. Right now we don't think we'll need to, but, again, it 

all depends on what happens in the conference the next few days 

for the 1998 budget. That same commitment stands; if we need it, 

we will move it. At this point, making an assumption about the 

amount of money we expect to get for 1998, we don't think that will 

be necessary. 

Mr. Kingston SMITH. Thank you. 

Mr. EVANS. Your testimony and the testimony of GAO indicates 

that the renovation of VBA's compensation and pension application 

appears to be a major hurdle. Can you describe in detail what the oversi~ht team recommended in this regard and outline what steps 

you will be taking to address this issue? 

Mr. CATLETT. Yes, sir, I'd ask Mr. Quinton to give you those details. 

Mr. QUINTON. Yes, sir, Mr. Chairman. We agree that the compensation and pension program is certainly our most critical system, and it is also one that we must pay closest attention to. In 

essence, the oversight team focused on the issue of increased management of the conversion eftbrt, and that effort is focused on a 

change in approach with our in-house staff at Hines. Their experience truly is in the development and maintenance of the compensa- tion system, where they have the expertise developed over some 20 

to 30 years. We have accelerated our effort to make the systems 

compliant, and in that process we have added a significant contractor effort. 

The concern raised in oversight is whether or not our staff, who 

over the years have been developing and maintaining that system, had the contract management expertise, and we recognize that that 

is a shortfall. So we have to provide training and provide onsite 

support to manage a contract. We do not believe this is insurmountable. In essence, with the contractor actually being onsite, 

working hand-in-hand with our developers, it becomes more manageable than it would be if the contractor was offsite and we were 

looking for a deliverable. So the focus truly is one of adding an 

extra task to our staff at Hines to say; in addition to doing the 

work that has been done for the last 25 or 30 years, also manage 

the day-to-day activities of a contractor. It is our intention right 

now to provide additional management support to the staff, as I 

said earlier, and to provide immediate training to our project management staff at Hines. 

Mr. CATLETT. Mr. Evans, I would add, I think as I noted earlier, 

this obviously will be an item that we will review in our monthly 

status reports with Mr. Quinton, and we'll be glad to keep the committee informed of our progress there. 

Mr . EvANS. All right. With regard to the medical device issue, 

are you satisfied with the feedback you've received to date from the 

manufacturers? Do you believe that the Food and Drug Administration has conducted sufficient outreach to accurately determine 

the severity of the problem among medical device manufacturers? 

Mr. CATLETT. The answer to your first question is yes, and I'm 

going to ask Dave to speak to the second because I think he's had 
17 

more direct communication and involvement than I have with the 

FDA. 

Mr. ALBINSON. Thank you, Mark. 

Earlier this month we sent a letter from the VA to the 1,580 

manufacturers of medical devices actually in use at our facilities. 

We have been very encouraged by the response of industry to this 

letter, and over the past 3 weeks we've already received nearly a 

15 percent response rate. Of those who have answered back, 70 

percent have indicated that there is no time clock involved in their 

particular medical device; approximately 15 of the remaining 30 

percent, were almost half, have indicated that they do use a clock; 

It is compliant, and the remaining 15 percent have indicated that th~)' need to check further into the problem. Working through the numbers, that means that we have somewhere between 200 and 300 manufacturers of biomedical devices 

which may produce an issue for us. We feel this is a manageable 

number, and we're addressing it directly, and we've been very encouraged by the cooperation we've received from industry. 

Mr. EVANS. Can I get you to submit that data for the record, 

please? 

Mr. ALBINSON. I certainly will. 

Mr. EVANS. Thank you. 

(Subsequently, the Department of Veterans Affairs provided the 

following information:) 
Status of Medical Device Manufacturer Responses to VHA 

(as of September 23, 1997) 

Total Number of Manufacturers Written to: 1580 

Total Number of Responses Received: 213 

Percentage of Manufacturers Responding: 13.5% 

Date Manufacturers Manufacturers Manufac

asserting product(s) asserting asserting responses 

received have no time clock, product(s) have a product(s) 

and are therefore time clock, have further ana

compliant been checked, determ

and are compliant complia

19-5ep-1997 76 15 12 

23-Sep-1997 74 14 22 

Total 150 29 34 

% of Total 

Resp~llses 70% 14% 16% 

-
19 

Mr. EVANS. All right, I yield to majority counsel. 

Mr. Kingston SMITH. Thank you. What action does the VHA plan to take on those manufacturers 

who have not responded to your September 9, 1997 letter? 

Mr. ALBINSON. Well, we're going to give it a little more time. It's 

been 2 weeks. At some point we will follow up with them directly, 

and the letter was couched such that it required a res~nse whether or not they thought there was a problem. So we mtend to get 

a response from all 1,580 manufacturers eventually. Mr. Kingston SMITH. At this point does VHA have any indications of Y2K compliance problems with any of its biomedical equipment? 

Mr. ALBINSON. Our current indications are that 15 percent of the 

respondents have indicated that they need more time in order to 

get back to us, and we're assuming that there may be problems 

with those manufacturers. They have been highlighted in our 

efforts. 

Mr. CATLETl'. Kingston, I'd add that we would, if we have difficulty with manufacturers corresponding with us, this is an issue 

that we'll raise back through the CIO council committee on this 

that I believe FDA has. I know it's an HHS-Ied effort, and we will 

make sure that that committee and OMB, if necessary, are involved with that, to bring some leverage to getting that attention 

on this issue. So it's something that, as Mr. Albinson said, we will 

follow up ourselves this fall, in the month of October, and if there's 

continued lack of correspondence, then it's an issue that we'll raise 

within the administration with the OMB-Ied effort to make folks 

aware of that, to try to bring some more leverage on the issue. 

As we testified, we're not probably-for many of these companies, 

we do a lot of business from our view, but from their view we may 

not be a large customer. So we wanted to bring all the leverage we 

can with the Federal Government effort, not just our own. 

Mr. EVANS. I want to thank the panel for testifying today, and 

we'll excuse you right now. 

Mr. CATLETT. Thanks. 

Mr. EVANS. And at this time we'll bring our third panelist forward: Tom Shope, Acting Director of the Division of Electronic and 

Computer Science, Office of Science and Technology, Center for Devices and Radiological Health, of the Food and Drug Administration. 

Doctor, you may proceed when you're ready. 

STATEMENT OF THOMAS SHOPE, ACTING DIRECTOR, DM· 

SION OF ELECTRONIC AND COMPUTER SCIENCE, OFFICE OF 

SCIENCE AND TECHNOLOGY, CENTER FOR DEVICES AND RA· 

DIOLOGICAL HEALTH, FOOD AND DRUG ADMINISTRATION 

Mr. SHOPE. Thank you. Good morning, Mr. Chairman and members of the subcommittee. I'm Thomas Shope. I'm the Acting Director, as the chairman said, of the Division of Electronics and Computer Science in the Office of Science and Technology' of the Center 

of Devices and Radiological Health of the Food and Drug Administration. 

Having previously testified before this subcommittee at the June 

26th hearing, I'm pleased to be here today to provide further infor-
20 

mation about the year 2000 date issue and its impact on medical 

devices. Although FDA has not received any significant information 

since the previous hearings to indicate that there will be any major 

impact on medical device safety, I am here to assist the committee 

in its efforts to examjne the issue. 

FDA is responsible for proUding the public health by helping ensure that medical devices are safe and effective. Any computer software that meets the statutory definition of a medical device is subject to applicable FDA medical device regulations. An issue that 

has been identified as warranting review is the impact of the year 

2000 on some medical device computer systems and software applications. These products could be impacted by the year 2000 date 

problem only if they use a date in their algorithm or calculation or 

function or in recordkeeping and if a two-digit year format for the 

date was used in their design. 

At the last hearing, I described some of the technical issues associated with the types of products that we regulate. I'1l not go into 

that in detail today. It is in our written testimony. 

In July, the Center sent a letter to all medical device manufacturers, approximately 13,000, both domestic and foreign, to ensure 

that manufacturers were addressing the year 2000 issue, and we 

reviewed both embedded and non-embedded software product issues in that letter. In addition, we asked manufacturers to review 

any computer-controlled design, froduction, or quality control processes for the possible impact 0 a two-digit date in any of these 

computer applications. 

This letter reminded manufacturers that, pursuant to manufacturing regulations, they have a legal obligation to investigate and 

correct devices that fail to operate according to their specifications 

because of an inaccurate date-recording or calculation operation. 

Our letter did not require a response from the manufacturers. 

We have regulations already in place that require manufacturers 

to notify us, FDA, of problems with devices that could lead to a significant risk to public health. 

For devices that are already on the market, we requested manufacturers to conduct hazards and safety analyses to determine 

whether device performance is affected. We expect manufacturers 

who identify products which have a date-related problem that could 

affect safety or effectiveness of a device to take the necessary action to remedy the problem. It is the obligation of the manufacturers to notify FDA of problems with devices that present a risk of 

serious injury, and of corrective actions taken to reduce a risk to 

health. Again, let me stress that we do not anticipate a large number of devices to be impacted or a large number of significant problems which would affect patient safety with individual medical devices. We want to ensure the continued safety and effectiveness of 

these devices by addressing the issues before they arise. 

Currently, and for future medical device pre-market submissions 

for new products, FDA will review device design and function to assure that the products have been designed to perform date recording and computations properly and safely. We will also be working 

with manufacturers on any reported problems with the devices that 

are currently on the market and in monitoring their activities. 
21 

Thank you, Mr. Chairman, for the opportunity to tell you about 

the issue of the year 2000 in medical devices. Let me assure you 

that we at FDA take this issue very seriously, as we do all problems that could affect public health. We have been evaluating the 

possible impact on devIces since early last year. We are committed 

to a scientifically-sound regulatory environment that will provide 

Americans with the best medical care. FDA has looked at this issue 

and does not see any major problem with medical devices that cannot be addressed satisfactorily. It is the manufacturer's responsibility to meet high standards in the design, manufacture, and evaluation of their products. They are ultimately responsible for these 

products, but FDA will provide the rellUlatory framework to ensure 

that the collaborative efforts of both the FDA and the manufacturers result in the best medical device products. 

That's all my oral statement, sir. 

[The prepared statement of Mr. Shope appears on p. 58.] 

Mr . EVANS. Thank you, Doctor. Your testunony indicates that the 

FDA has sent a letter to all medical device manufacturers reminding them of their obligation to advise the FDA, should there be any 

serious safety risk associated with the year 2000 problem. Given 

the FDA's ultimate responsibility to address the year 2000 problem, what additional steps will you be taking to ensure the safety 

and effectiveness of such devices? 

Mr. SHOPE. There are a number of steps that we are involved in 

or that we are contemplating taking to further our activities in this 

area. For one thing, we'll be stressing with our inspectional force 

that visit the manufacturing plants to raise this issue with the 

manufacturers during those inspectional visits. We will be carefully 

monitoring any reports of corrections or recalls that manufacturers 

are required to give us about products that could present a significant risk when they take an action to either correct a problem or 

to recall their product, and particularly we'll monitor those for any 

year 2000-type problems. 

We are probably most active with the Chief Information Officers' 

Subcommittee on the Year 2000 Working Group which is dealing 

with medical devices and scientific research instruments. These are 

two types of products for which the Federal Government has a 

large interest m the year 2000 compliance issue, as purchasers and 

users of those kinds of products, as well as an interest in making 

sure that the public users of those kinds of products have information on the possible year 2000 impact. 

This group is looking at ways to provide information to the Federal purchasers of these products, as well as to the public, on those 

products which will have problems due to the ,ear 2000 date problem, and the steps which the manufacturers 0 those products plan 

to take to deal with the problem. Our current approach to this is probably going to be the establishment of a website, hopefully in conjunction with the current 

GSA year 2000 website, and to provide the opportunity for manufacturers to provide information on that site regarding the year 

2000 status of their products. We would expect that this would be 

a mechanism where by the manufacturer could either provide the 

information which would be posted there or provide a link to their 

own web site, where they could provide the detailed information 
22 

themselves on the status of their products. This would provide a 

central facility for anybody who's concerned about their product 

status to check and verify. We will continue to look at new products coming to market to 

make sure they're compliant, and we'll investigate any reports, as 

we have been doing this summer, about products that may have a 

problem. We have seen in the public press and in other venues reports of products that have problems. We've actively investigated 

any of those that have come to our attention. Most of those-in 

fact, all of them that we have looked into-have turned out to be 

unfounded reports. It is not the defibrillators that are going to have 

problems as far as we can determine. Pacemakers are not ~oing to 

have problems. Our last episode was looking into the infusion 

pump issue. We contacted all the U.S. manufacturers of infusion 

pumps, and were not able to determine a date problem associated 

with the operation of infusion pumps from those contacts. 

So we will continue to actively follow up on any reports that we 

have. We expect that as manufacturers assess their products and 

determine that there may be a product that contributes a risk, we'll 

get that information from the manufacturer and we'll monitor their 

efforts to correct the problem. 

Mr. EVANS. Apparently, the FDA regulations require that manufacturers alert the agency if they think a medical devise poses a 

safety threat, but don't require manufacturers to provide feedback 

if they do not anticipate a safety. Put in fairly simply terms, how 

do we know whether the manufacturers are up-to-speed on possible 

year 2000 issues? How can we be sure that these manufacturers 

are properly addressing possible year 2000 issues? 

Mr. SHOPE. Well, I think we have taken a number of steps to 

make sure manufacturers are aware of the issue. I think our letter 

is the first step. We have had conversations with the ma;yor associations that represent the medical device manufacturers, the Health 

Industry Manufacturers Association, National Electrical Manufacturers Association, and the Medical Device Manufacturers Association-to bring it to their attention and to encourage their communication with their membership as to the problem and the need to 

take actions here, and to discuss with these groups the usefulness 

and receptivity of the industry to the website idea of a way to centralize and post the information. That's one of the areas where 

we've taken steps to try to make manufacturers aware of the issue. 

We'll continue to follow up on any voluntary reports and reports 

from user facilities that we obtain that would indicate a problem 

with a device. 

I think. manufacturers, though, outside our regulatory scheme, 

have the desire to satisfy their customers and some liability issues 

that would probably be more influential in their actions, perhaps, 

than some of the FDA :::~ries that we might be making as to the 

status of things. So It' there are a number of things that push 

the manufacturers to deal with this problem and to deal with it in 

an upfront manner. 

Mr. EVANS. From a policy perspective, do you believe your agency has the necessary tools to adequately survey and receive useful 

feedback from manufacturers on the year 2000 compliance issue? 

And given the unique nature of this issue and the limited amount 
23 

of time left to address it, is there anything Congress can do to assist you in getting a better handle on this situation? 

Mr. SHOPE. Well, I think we have done the things that the current law and regulations give us in the way of tools to explore 

these issues. I think if Congress has some other ideas on things 

that might be done to assist us in gathering information, we'd certainly be glad to discuss those with you and see what could be 

worked out there. 

We are different than, say, the Veterans Health Administration, 

who can go to a manufacturer and ask questions because of the 

contractual relationship they have as customers, and prospective 

customers, to be asking for information on things they may be buy- ing. We, as a regulatory agency, have to make sure we don't impose 

reporting burdens on manufacturers or the public that aren't appropriately consonant with our OMB reporting requirements, information request requirements. So we work within the existing framework. There might be some things that could be done to that 

framework that would give us additional flexibility, but I personally think that we have the tools that we need to address this prob- lem. The manufacturers will be responsible, will take the necessary 

actions. 

One of the things about medical technology is it's a very fastmoving kind of technology, so it wouldn't be unusual to find that 

only very old products are the ones that are affected here, and 

those are likely to be on a replacement schedule. 

Mr. EVANS. Your testimony indicates there are a very limited 

number of devices that will probably have year 2000 problems. Can 

you give us a list of devices that might have those kinds of problems that you're aware of at this time, and submit that to us for 

the record? 

Mr. SHOPE. We could attempt to put together such a list, I think. 

That will be based on our internal expertise of our medical device 

review staff as to the technologies involved and which ones of those 

could have a potential problem. Again, without knowledge of the 

actual algorithms that manufacturers have implemented, it's a little difficult to know exactly which products will or will not have 

problems. (See p. 72.) 

Mr. EvANS. At this time I recognize majority counsel. 

Mr. Kingston SMITH. Dr. Shope, what happens if manufacturers 

do not live up to their legal obligations and public responsibilities? 

What harm could come to members of the public and to veterans? 

Mr. SHOPE. If there is a product that somehow encounters a year 2000 problem, I think there's a possibility for either failure of diagnosis or failure of treatment, based on that failure. 

Mr. Kingston SMITH. Has the FDA done any systematic analysis 

of the types of risks that might be posed to the :public? 

Mr. SHOPE. As I sa~, when we started looking at this problem about a year-and-a-half ago, we had discussions with all the medical device review staff, basically polled and did a consideration of 

in what kinds of devices could a year 200O-associated problem lead 

to a significant risk to the patient or to public health, and I have 

to tell you that, from our internal discussions of our knowledge of 

the various technologies and the way devices function, it was a 
24 

rather short list of those that came up that could be potential prob- lems. We don't know for sure whether there are problems with 

those products because of not knowing the intimate details of the 

algorithms that were used, but we do have a list of a few kinds of 

products for which there is a potential for risk. Followups with 

some manufacturers of those products, however, have indicated 

that they are not subject, typically, to date problems because they 

didn't use a two-digit date format. 

Mr. Kingston SMITH. If a manufacturer doesn't live up to its obligations to make information available to the FDA, how will the 

FDA know there's a problem until after it's occurred? 

Mr. SHOPE. I think there will be a lot of commer~:)lkressure to 

satisfy customers, and 80 I think manufacturers are ely to not 

live up to their obligations. There are, of course, penalties for failing to notify FDA of problems that come to the attention of the 

manufacturer. We've put the manufacturers on notice that this is 

a potential problem with our letter. That means that they're obligated to investigate and to deal with any potential problem. Failure to do that is a violation of the regulations and would subject 

the manufacturers to sanctions. 

Mr. Kingston SMITH. Thank you. 

Mr. EvANS. Thank you, Doctor. We appreciate your testimony 

today. 

This concludes our hearing. Without objection, I will include 

Chairman Everett's closing statement in the record. 

[The statement of Chairman Everett follows:] 

CLOSING STATEMENT 

I appreciate the attendance and testimony of our witneaaea this mominlf. 

It does appear that VA, particularly the Benefits Administration, 18 making 

progress on Y2K compliance. But, as GAO points out, substantial risks remain for 

the VA, and that means substantial risks remain for our veterans. So we're not out 

of the woods yet. 

I remain concerned about the biomedical equipment situation. It's a much bigger 

problem than just the VA. FDA's rather relued approach strikes me as inadequate and I do not see the kind of leadership within the administration that is neceaaary 

to assure the American public that the biomedical equipment used in this COUDtry 

is going to be safel>.' and effectively operating on January 1 2000. The basic ap- proach of leaving It up to the equipment manufacturers does not inspire con- fidence-at least not my confidence. I mtend to continue my interest in this subject. 

This baa been hearing II on these issues. In the next aeaaion, or sooner if need 

be, the subcommittee will have more hearings, and we will maintain our focus until 

the VA baa achieved full Y2K compliance and we can tell our veterans that. 

Mr. EVANS. I thank all the witnesses and interested citizens for be~g here today, and we now conclude the hearing. [Whereupon, at 11:05 p.m., the subcommittee adjourned subject 

to the call of the Chair.] 
APPENDIX 

REMARKS OF THE 

HONORABLE JAMES E. CLYBURN 

RANKING DEMOCRATIC MEMBER 

SUBCOMMITTEE ON OVERSIGHT 

AND INVESTIGATIONS HEARING 

ON YEAR 2000 COMPLIANCE 

SEPTEMBER 25. 1997 

I WOULD LIKE TO COMMEND CHAIRMAN 

EVERETT FOR HAVING THE FORESIGHT TO PUT 

TOGETHER THIS CRITICAL HEARING THIS 

MORNING. 

IF THE VA IS UNABLE TO SUCCESSFULLY 

MANAGE ITS TIME AND RESOURCES TO DEAL 

WITH THE IMPENDING YEAR 2000 CRISIS, IT WILL 

PLACE THE VETERANS IT EXISTS TO SERVE AT 

GREAT RISK. 

(25) 
26 

I AM PLEASED THAT THE VA HAS BEGUN THE 

MAJOR SYSTEM-WIDE CHANGES THAT MUST BE 

DONE IF VA IS ABLE TO BRING ITS MISSION 

CRITICAL SYSTEMS INTO YEAR 2000 

COMPLIANCE. 

THE VA, AND PARTICULARLY THE VETERANS 

BENEFITS ADMINISTRATION, HAS BEEN WORKING 

HARD OVER THE PAST SEVERAL MONTHS TO 

ADDRESS THE YEAR 2000 ISSUE, AND I WANT TO 

COMMEND THEM FOR THEIR EFFORTS. 

THE YEAR 2000 PROBLEM IS OF CRITICAL 

CONCERN TO THIS COMMITTEE AND TO OUR 

VETERANS. THANKS TO THE LEADERSHIP OF 

CHAIRMAN EVERETT, THE VA CAN EXPECT 

CONTINUED OVERSIGHT ON THIS ISSUE 
2'1 

THROUGHOUT THE REMAINDER OF THIS 

CONGRESS. 

THANK YOU AGAIN, MR. CHAIRMAN. I LOOK 

FORWARD TO THE TESTIMONY THIS MORNING. 
28 

CONGRESSMAN MASCARA'S STATEMENT 

V A HEARING ON YEAR 2000 COMPUTER COMPLIANCE 

SEPTEMBER 25, 1997 

GOOD MORNING MR. CHAIRMAN. I AM PLEASED 

TO BE TAKING PART IN THIS IMPORTANT HEARING TO 

ASSESS WHAT PROGRESS THE VA HAS MADE IN 

RECENT MONTHS IN FIXING THE YEAR 2000 

COMPUTER COMPLIANCE PROBLEM. 

I READ OVER THE PREPARED TESTIMONY LAST 

EVENING AND I AM SOMEWHAT TORN BY WHAT IT 

INDICATES. WHILE I WAS GLAD TO READ THAT THE 

OFFICE OF MANAGEMENT AND BUDGET HAS 

DETERMINED THE VA IS MAKING MUCH MORE 

PROGRESS THAN MANY OTHER AGENCIES, I REMAIN 

WORRIED THAT THE PROGRESS IS NOT FAST ENOUGH, 

IF THE SITUATION DOES NOT DRAMATICALLY 

IMPROVE, I AM AFRAID VETERANS COULD STILL FIND 

THEMSELVES FACING DELAYED PAYMENTS AND 
29 

COUNlLESS OTHER PROBLEMS ONCE THE CALENDER 

REACHES JANUARY 1,2000. 

THIS IS UNACCEPTABLE AND I WANT TO GET 

SOME REASSURANCE TODAY FROM V A OFFICIALS 

THAT THEY ARE SOMEHOW GOING TO RECTIFY THIS 

SITUATION, PARTICULARLY AS IT PERTAINS TO 

COMPUTER PROGRAMS HANDLING V A PENSIONS, 

HEALTH AND GJ. BENEFITS. 

I ALSO MUST SAY THAT I CONTINUE TO BE 

ASTONISHED THAT THE EXECUTIVE BRANCH DOES 

NOT YET SEEM TO GRASP THE SERIOUSNESS OF THE 

PROBLEM IT FACES IN MAKING SURE ALL 

GOVERNMENT COMPUTERS ARE ABLE TO HANDLE 

THE TRANSITION TO THE NEXT CENTURY. 

I WAS STUNNED TO READ IN THE GAO 

TESTIMONY THAT 75 PERCENT OF OUR AGENCIES' SOCALLED "MISSION-CRITICAL SYSTEMS" STILL NEED 

45-928 - 98 - 3 
30 

TO BE REPAIRED OR REPLACED AND THAT THE 

TOTAL COST HAS NOW RISEN ANOTHER $1 BILLION 

TO $3.8 BILLION. 

AS I SAID AT THE LAST HEARING, THE PRESIDENT 

NEEDS TO APPOINT A COMPUTER CZAR TO DEAL 

WITH THIS PROBLEM AND HE OUGHT TO DO IT NOW. 

WHEN I WAS SERVING IN COUNTY GOVERNMENT, 

MANY YEARS AGO, WE WERE TALKING ABOUT HOW 

THE COUNTY WAS GOING TO DEAL WITH THIS 

PROBLEM. 

IT IS SIMPLY AMAZING TO ME THAT A LOCAL 

GOVERNMENT HAD THE FORESIGHT TO RECOGNIZE 

THAT THE YEAR 2000 PRESENTED A MAJOR 

COMPUTER PROBLEM AND BEGAN TO WORK 

TOWARDS A SOLUTION, WHILE THE FEDERAL 

GOVERNMENT WAS "FIDDLING WHILE ROME WAS 

BURNING." 
31 

AGAIN, WE MUST ALL DO BETTER AND 

HOPEFULLY THIS HEARING TODAY WILL SPUR 

FURTHER ACTION. 

THANK YOU MR. CHAIRMAN. I YIELD BACK THE 

BALANCE OF MY TIME. 

THE END 
GAO 

For __ COl DeIhery 

Eapoctod9:JOLIL 

'IlIondIJ. 

~25.1997 

GAOII' ·AIMD-f7·174 

32 

Testimony 

Before die Subc:ommitlee OIl Oversisht UId Investigllioos. 

Conunittee on VeterIIIs' Aft'aira. House ofRep-rativea 

VETERANS AFFAIRS 

CO:MPUTER SYSTEMS 

Action Underway Yet Much 

Work Remains To Resolve 

Year 2000 Crisis 

StaIemeIU of Joel C. Wil1emssen 

DirecIor. InformaIioo Resounles Manaaemeot 

ACCOIIIItiq UId InformaIioo Manaaemeot Divilioo 

• 
33 

Mr. Chairman and Members of the Subcommittee: 

We are pleased to be here today to discuss the progress being made by the federal 

government and, in particular, the Department of Veterans Affairs (V A), in making sure 

that its automated information systems are ready for the upcoming century change. As 

you know, we testified before the Subcommittee earlier this summer, at which time our 

report was released detailing the activities of one V A component!, the Veterans Benefits 

Administration (V8A), to make its systems Year 2000 .compliant.2 

As requested, my testimony today will first summarize federal progress in addressing 

the Year 2000 problem and will then examine VA and its major components. My 

statement will discuss action taken by V A as a whole, and steps taken by VBA in 

response to recommendations contained in our recent report. We have just begun a 

detailed review of the Veterans Health Administration's (VHA) Year 2000 activities; 

consequently, my testimony in this area will be limited to results to date. 

!Along with VSA, the other two major VA components are the Veterans Health 

Administration and the National Cemetery System. 

2Veterans Benefits Computer Systems: Uninterrupted DelivetY of Benefits Dl:pends on 

Timely Correction of Year-2000 Problems (GAO/T-AIMD-97-114, June 26,1997) and 

veterans Benefits Computer Systems: Risks of VBA's Year-2000 Efforts (GAOl AIMD-97· 

79, May 30, 1997). 
FEDERAL AGENCY PROGRESS: 

EFFORTS MUST BE EXPEDITED 

As we testified in July,J time is running out for agencies and the pace needs to be 

accelerated if widespread systems problems are to be avoided as the Year 2000 

approaches. We stressed in our testimony that the Office of Management and Budget 

(OMB) and key federal agencies need to move with more urgency. Among the other 

related issues we noted was that increased attention was required on validation and 

testing of Year 2000 solutions, data interfaces and exchanges, and contingency planning. 

OMB's most current Year 2000 progress report on the federal government's efforts, 

released last week, again demonstrates that although federal agencies are generally 

making progress toward achieving Year 2000 compliance, the overall pace of that 

progress is too slow.~ Based on individual agency reports, 75 percent of the agencies' 

approximately 8,500 mission-critical systems remain to be repaired or replaced, and the 

3Year 2000 Computing Crisis: Time Is Running Out for Federal A~ to Prepare for 

tbe New Mjllennium (GAO/T-AIMD-97-129, July 10, 1997), before the Subcommittee on 

Government Management, Information and Technology, House Committee on 

Government Reform and Oversight, and the Subcommittee on Technology, House 

Committee on Science. 

~Pmgress on Year 2000 Conversion. U.S. Office of Management and Budget, August 15, 

1997. 

2 
35 

total cost estimate has risen to $3.8 billion, up $1 billion from the previous quarterly 

report.5 

According to OMB, reports of several of the agencies were disappointing; consequently, 

it placed agencies in one of three categories, depending upon evidence of progress. In 

the first catego?, are four agencies that OMB found had "insufficient evidence of 

progress:" For these agencies, OMB established a "rebuttable presumption going into 

the Fiscal Year 1999 budget formulation process this Fall that we [OMB) will not fund 

requests for information technology investments unless they are directly related to fixing 

the year 2000 problem." 

OMB's second category contains 12 other agencies for which it cited "evidence of 

progress but also concerns:' These agencies were put on notice that continued funding 

for information technology investments would be contingent on continued progress.7 

Finally, for the eight remaining agencies that, according to OMB, appear to be making 

progress-and this includes V A-funding requests will be handled in the usual manner, 

'Gettin& Federal Computers Ready for 2000: Progress Report U.S. Office of 

Management and Budget, May 15, 1997. 

'Agriculture, Education, Transportation, and the Agency for International Development. 

7These are Commerce, Defense, Energy, Health and Human Services, Interior, Justice, 

Treasury, Environmental Protection Agency, Federal Emergency Management Agency, 

National Aeronautics and Space Administration, Office of Personnel Management, and 

Small Business Administration. 

3 
36 

although progress at all agencies will be reevaluated on the basis of their next quarterly 

reports, due November 15.' 

We are encouraged by OMB's statements and believe they reflect an increased urgency 

to address the Year 2000 issue. Further, we note that in its report, OMB states that it 

plans to address other issues that we raised in our July testimony.' 

• OMB emphasized that proper validation of changes was critical to success. It 

stated that it planned to meet with agencies over the coming months to discuss 

the adequacy of scheduled timetables for completing validation. 

• OMB said it would discuss with agencies the preparedness of communications 

interfaces with systems external to the federal government, including those of 

state and local governments and the private sector. 

• OMB asked agencies for a summary of the contingency plan for any missioncritical system that was reported behind schedule in two consecutive quarterly 

reports so that it could summarize such plans in future reports to the Congress. 

We look forward to implementation of these key activities as we continue monitoring 

OMB's leadership of the federal government's Year 2000 effort. 

'Along with VA, this category encompasses Housing and Urban Development, Labor, 

State, General Services Administration, National Science Foundation, Nuclear Regulatory 

Commission, and Social Security Administration. 

'GAO/T-AlMD-97-129. 

4 
37 

VA; DiE STAKES ARE HIGH 

V A is very vulnerable to the impact of the new millennium because of the large number 

of veterans and their dependents that it serves; this is why it is so important that V A's 

systems be made compliant in time to avoid disruption to the benefits and services on 

which millions.of Americans depend. Our past and current work at VA indicates that 

the Department recognizes the urgency of its. task, and it has made progress. But much 

remains to be done if it is to avoid the widespread computer failures that unmodified 

systems could bring. If left uncorrected, the types of possible problems that could occur 

include but are not limited to late or inaccurate benefits payments, lack of patient 

scheduling for hospital treatments, and misinterpretation of patient data. The number of 

areas vulnerable to problems is vast. 

The Department's June 1997 Year 2000 plan (YA Year 2000 Solutions) outlines VA's 

strategy, activities, and major milestones. According to this plan and in line with OMB 

guidance, V A's primary approach is to make its 11 existing mission-critical systems 

compliant; one, in fact, already is. Table 1 lists these systems, along with the numbers of 

applications they serve and the responsible V A component or office. 

5 
38 

Table l' VA's Mjssion~ritical Computer Systems (11) and Their AWlications (464) 

Component/Office Number of 

(Number of Systems) Systems Applications 

Veterans Benefits Administration • Compensation &: Pension 157 

(6) • Education 

• Insurance • Loan Guaranty • Vocational Rehabilitation 

• Administrative 

Veterans Health Administration • Veterans Health Information 143 

(2) Systems and Technology 

Architecture 

• Veterans Health 160 

Administration Corporate 

Systems 

National Cemetery System (1)" • Burial Operations Support 2 

System/ Automated 

Monument Application 

System-Reengineer 

Office of Financial Management • Personnel and Accounting 1 

(2) Integrated Data 

• Financial Management System 1 

"The only system that VA considers to be fully Year 2000 compliant. 

Source: VA. 

Responsible for overseeing the Year 2000 problem at VA is its chief information officer 

(CIO); he is assisted by the CIOs of both VBA and VHA, by senior information 

technology managers in the National Cemetery System, and by staff offices at VA 

headquarters. VA has also designated a Year 2000 project manager, responsible for 

general oversight and monitoring. 

6 
39 

According to VA's August 14, 1997, quarterly report to OMB, the Department has made 

progress in addressing the Year 2000 problem. As noted in the report, one of its 11 

mission-critical systems-the one serving the National Cemetery System-is already fully 

compliant. Of the. ten remaining mission-critical systems and their applications, 85 

percent have been assessed and 51 percent have been renovated. In addition, VA has 

updated its total Year 2000 cost estimate from $144 million (May 1997) to $162 million; 

VA's stated reason for the increase is the need for upgrades to its commercial off-theshelf software and hardware, and more contractual support. 

Further, VA's current estimate shows that it expects systems assessment to be completed 

by the end of next January, renovation of systems by November 1998, validation by 

January 1999, and implementation by OctoQer 1999-2 months earlier than VA reported 

in May. 

VBA HAS BEGUN TO IMPl.EMENT 

GAO RECOMMENDATIONS 

As we testified before the Subcommittee in June,t° correcting the Year 2000 problem is 

critical to VBA's mission of providing benefits and services to veterans and their 

dependents. VBA has responded to this challenge by initiating a number of actions, 

ID(;AO/T-AlMD-97-114, June 26,1997. 

7 
40 

including developing an agencywide plan and a Year 2000 strategy, and creating a 

program management organization. However, several substantial risks remain. If VBA 

is to avert serious disruption to its ability to disseminate benefits, it will need to 

strengthen its management and oversight of Year 2000-related activities. 

Our May 30, 1997, report contained ten specific recommendations to the Secretary of 

Vetl!rans Affairs on actions that VBA needed to take to address the Year 2000 problem. II 

V A concurs with all ten, and is in the process of implementing them. For example, 

according to VBA: 

• To strengthen its Year 2000 program management office, it has assigned oversight 

and coordination responsibilities for all Year 2000 activities to this office alone. 

• It has completed inventories of data interfaces and third-party products 

(hardware, sohware, mainframes, minicomputers, operating systems, and utilities). 

VBA has also determined that most of its third-party products are Year 2000 

compliant-98 percent of its personal computers, local area networks, 

minicomputers, and commercial sohware; and all of its imaging equipment and 

associated sohware. 

• It has renovated half of the 157 applications that make up its six mission-critical 

systems. It plans to renovate the remaining applications by November 1998. 

IIGAO/ AlMD-97-79. 

8 
While we are encouraged by these positive actions, we understand from discussions 

with VBA officials that key work schedules have been compressed, creating added 

pressure. For example, renovation of VBA's largest and most critical applications-those 

necessary to the functioning of its Compensation and Pension Service-may not be 

completed by VBA's target date of December 1998. Changes to these applications have 

had to be delayed in order to effect this year's legislatively mandated changes and costof-living increases. Time is simi1arly short for work on the loan guaranty system, for 

which all phasesl2-including assessment-remain to be completed. For example, the new 

claims and verification application is scheduled to start in early fiscal year 1998, but it 

has a fail date13 of December 1998. This leaves VBA only slightly over one year to 

design, develop, test, and implement this application. 

A further challenge for VBA is that it has not modified its schedule to take into account 

recent problems and delays in its attempts to replace an education payment system for 

selected reservists known as chapter 1606. Such schedules are important to ensuring 

that all mission-aitica1 applications are fixed; they therefore need to be modified or 

updated to reflect realistic estimations of the difficulty of the work involved. 

1~ Year 2000 program phases are 1ZWQrene5S, /lSSeSsmDlt, rmDfHItion, validation, and 

implnnenttllion. 

IlJhe date on which this application will experience the effects of dates on cakulations. 

9 
42 

In addition, although VBA has completed an inventory of 590 internal and external 

interfaces, as of July 31, 1997, only 26 percent of the interfaces had been assessed for 

compliance. VBA's Year 2000 project manager indicated that VBA is encountering 

problems determining whether its external interfacesl

• are Year 2000 compliant because 

external sources have not provided the necessary information. 

VBA also has not updated its January 1997 risk assessment to reflect the recent change in 

its Year 2000 strategy. Specifically, in response to concerns raised regarding its initial 

approach, VBA redirected its Year 2000 strategy by focusing on converting its existing 

benefits payment systems rather than replacing the noncompliant systems. Since risk 

assessment is an important prerequisite fOr effectively prioritizing projects and 

mitigating potential problems, updating the previous risk assessment to take this change 

into account is essential. 

An internal VA oversight committee, established to monitor and evaluate the progress of 

VBA's Year 2000 activities, identified concerns similar to ours. Specifically, according to 

a member of this committee, little time remains for VBA to make the necessary 

modifications to its compensation and pension and loan guaranty systems, and much 

work remains in assessing the external interfaces for compliance. 

14An example of an external interface is the exchange of disability compensation 

information between the Department of Defense and VBA. Defense currently provides 

VBA with electronic information on the amount of disability benefits paid to a veteran 

by Defense for offset against the amount paid by VBA to this same veteran. This offset 

is necessary because, by law, the veteran cannot be paid twice for the same disability. 

10 
43 

VHA HAS BEGUN TO ASSESS ITS SYSTEMS 

AND RELATED PRODUCTS FOR COMPLIANCE 

The Year 2000 challenge for VHA is enormous. As the largest centrally directed civilian 

health care system in the United States, VHA manages health care delivery to veterans 

within 22 regional areas geographically dispersed throughout the country; these areas 

are known as Veterans Integrated Service Networks (VlSNs), and they encompass 173 

V A medical centers, 376 outpatient clinics, 133 nursing homes, and 39 domiciliaries-a 

total of 721 facilities. These sites utilize a wide range of electronic information systems, 

biomedical equipment, facilities systems, and other computer-based system products. 

Accordingly, it is essential that each of these 22 regional health care networks thoroughly 

assesses and plans for ensuring Year 2000 compliance so that service delivery is not 

interrupted. 

Within VHA, the CIO has overall responsibility for planning and managing Year 2000 

compliance. The CIO created a VHA Year 2000 project office, empowered to develop 

compliance guidance. In April 1997 this office developed a VHA plan for addressing the 

year 2000; the pian was approved by VA's Under Secretary for Health on May 14 of this 

year. The CIOs of each of the 22 regional networks, medical facility directors, and 

managers have ultimate responsibility for preparing and executing their individual Year 

2000 plans, including all required assessment, renovation, validation/testing, and 

implementation activities. 

11 
According to VA's August 14, 1997, quarterly report to OMB, VHA is in the initial stages 

of assessing the compliance of its two mission-critical systems-the Veterans Health 

Information Systems and Technology Architecture (VISTA)ls-formerly known as the 

Decentralized Hospital Computer Program (DHCP)-and the VHA corporate systems, 

V A also reported that of the two systems' applications, 17 percent have been assessed 

and 16 percent renovated. VHA plans to complete this assessment and renovation by 

the end of January 1998 and July 1998, respectively. 

According to VA's Year 2000 readiness review, VHA's strategy for the national VISTA 

applications is to assess all 143 applications and recode as necessary. According to 

VHA, 34 of its 143 applications16 have been assessed; 33 of these 34 were eliminated as a 

result of the assessment. 

In order to effectively assess and renovate, it is necessary to understand how local 

facilities are using the national VISTA applications. One potential risk is that some local 

facilities have customized national applications, according to VA's Year 2000 readiness 

lsVIST A represents the national health care information applications along with related 

commercial products, personal computers/workstations, and other items used in VHA 

health care facilities. 

16Examples of applications include dietetics, pharmacy/inpatient, health summary, 

prosthetics, and laboratory. 

12 
45 

review.17 If this is true, it is important that VHA know where applications have been 

changed-even in small ways-so as to ensure that they are Year 2000 compliant. Beyond 

customization, local facilities may purchase software add-ons to work with the national 

applications; here, too, these must be inventoried and Year 2000 compliance assessed. 

An inventory of internal and external VISTA interfaces has not yet been completed; 

systems developers plan to identify such interfaces when they assess each application. 

Should internal information be corrupted by exposure to uncorrected external interfaces 

through network exchanges, system crashes and/or loss of data could result. VA's Year 

2000 project manager has expressed concern that this information may not be obtainable 

from external sources, who have yet to inform VHA whether their interfaces are Year 

2000 compliant. 

As with interfaces, VHA must be assured that the commercial software products it uses 

are Year 2000 compliant. It has completed an inventory of its commercial products, such 

as personal computer operating systems, office automation software, and medical 

applicalions; according to the project manager, over 3,000 software products and 1,000 

software vendors have been identified. VHA plans to rely on the General Services 

Administration to provide it with a general list of commercial products that are Year 

17Such customization includes special-purpose programs written by local information 

resources management staff or other system users on-site or imported from other VA 

medical centers. They generally meet a specific local need or extend the functionality of 

nationally released software. 

13 
46 

2000 compliant. For specialized products unique to the health care industry, VHA plans 

to contact manufacturers for compliance information. 

Physical facilities are another area of concern. According to VHA's Year 2000 program 

manager, VHA has not completed an inventory of facilities-related systems and 

equipment such as elevators; heating, ventilating, and air conditioning equipment; 

lighting systems; security systems; and disaster recovery systems. Such elements are 

vitally important to VHA's ability to provide high-quality health care services. VHA is 

working with the General Services Administration and manufacturers on this issue. 

Since it is often critical that medical services not be interrupted, VHA is required to have 

contingency plans in place in case hospital systems fail. These plans are reviewed and 

assessed regularly by the Joint Commission on Accreditation of Healthcare 

Organizations. However, such contingency plans are meant to ensure continued 

operation in the event of disaster; such approval does not necessarily ensure that all 

backup systems are Year 2000 compliant. 

VHA IS ASSESSING YEAR 2000 lMPACf ON MEDICAL DEVICES 

Health care facilities depend on the reliable operation of a variety of biomedical devicesequipment that can record, process, analyze, display, or transmit medical data. 

Examples include computerized nuclear magnetic resonance imaging (MRI) systems, 

14 
47 

cardiac monitoring systems, cardiac defibrillators, and various tools for laboratory 

analysis. Such devices may depend on a computer for calibration or day-ta-day 

operation. This computer could be either a personal computer that connects to the 

device from a distance, or a microprocessor chip embedded within the device. In either 

case, the software that controls the operation of the computer may be susceptible to the 

Year 2000 problem. The impact could range from incorrect formatting of a printout to 

incorrect operation of the device, having the potential to affect patient care or safety. 

The risks for a specific medical device depend on the role of the device in the patient's 

care and the design of the device. Although medical treatment facilities have the 

expertise to understand how medical devices are used, they rely on device 

manufacturers to analyze designs and disclose Year 2000 compliance status. 

As a health care provider and user of medical devices, VHA is a key stakeholder in 

determining compliance of such tools. Another key player is the Food and Drug 

Administration (FDA), in its role of protecting the public from unsafe and/or ineffective 

medical devices. 

In attempting to ascertain the potential impact of the century change on its biomedical 

devices, VHA on two separate occasions sent letters to manufacturers. Its first letter was 

sent over a period of a few days beginning June 23 of this year to equipment 

manufacturers identified by selected experts within VHA. In the letter, VHA inquired as 

15 
to steps the manufacturer planned to take to resolve the Year 2000 issue. Out of 118 

letters, VHA received 32 responses. These responses were reviewed by VHA's medical 

device integrated product team, comprising internal experts from a variety of fields. 

On the basis of the team's analysis, VHA sent more detailed letters asking specific 

questions, including whether the manufacturer provided any devices to V A that 

incorporate a real-time clock; if such devices were provided, whether they are Year 2000 

compliant; and for those that are not compliant, asking for model numbers, device 

names, and the specific impact the century change would likely have on the device. 

These letters were sent to about 1,600 manufacturers on September 9, 1997, with a 

request for responses by October 3. According to VHA, 50 responses had been received 

as of September 15. 

Product team members plan to review responses to ensure that they are categOrized 

correctly as compliant, noncompliant, or pending; VHA will maintain a database of the 

manufacturers and their responses. This database will be made available to VA medical 

centers through the VHA intranet, although key personnel such as biomedical engineers 

may not have easy access to the intranet at some medical centers. The information will 

also be communicated to V A medical centers through monthly conference calls among 

engineers and communications with medical center directors. We feel that it is 

imperative that such results be widely disseminated; if the VHA intranet is insufficient 

for this task, other means should be found. 

16 
49 

FDA also recently began communicating with manufacturers. According to officials, 

FDA sent a letter in early July of this year to about 13,000 such manufacturers, 

reminding them of their responsibility to ensure that their products will not be affected 

by the century change. In the letter FDA reminded manufacturers that, according to 

section 518 of the Federal Food, Drug, and Cosmetic Act, they are required to notify 

users or purchasers when FDA determines a device presents an unreasonable risk of 

substantial harm to public health. Although one response was received, the acting 

director of FDA's Division of Electronics and Computer Science explained that It was not 

the agency's intention to solicit a specific response because FDA expects manufacturers 

to report any problems found through normal reporting channels. FDA plans to 

disseminate information on any Year 2000 problems reported by manufacturers to the 

public through its reporting systems, such as the Medical Products Reporting Program 

{"MedWatch"). 

According to the director of FDA's Cardiovascular Division, the agency's strategy for 

helping to determine whether medical devices are Year 2000 compliant is to rely on the 

knowledge and experience of its resident experts. These experts, with backgrounds in 

electrical engineering, software engineering, and/or biomedical engineering, have 

reviewed the design of selected medical devices to determine whether the devices would 

be affected by the century change. In the case of pacemakers, for example, FDA experts 

have concluded that no adverse effect will result. This conclusion was based on the fact 

that the internal operations of pacemakers do not involve dates. The experts further said 

17 
50 

that although pacemaker settings are often changed with the assistance of a computer, 

which often uses dates and may be noncompliant, a trained physician is always involved 

in controlling the settings. 

A federal entity-the Year 2000 Subgroup on Biomedical Equipment-is working to 

coordinate the effort to obtain Year 2000 compliance status information from medical 

device manufacturers. This group plans to follow up on nonrespondents to 

questionnaires sent out by VHA, FDA, and other federal health care providers to 

manufacturers requesting this information. 

In closing, Mr. Chairman, I want to stress that while our detailed review of the VHA 

area is just now underway, it is clear that for VA as a whole to have all of its missioncritical systems compliant by January 1, 2000 will entail a huge, well-coordinated effort. 

This concludes my statement. I would be happy to respond to any questions that you or 

other Members of the Subcommittee may have at this time. 

(511236) 

18 
51 

STATEMENT BY 

THE HONORABLE D. MARK CATLETT 

ACTING ASSISTANT SECRETARY FOR MANAGEMENT AND 

ACTING CHIEF INFORMATION OFFICER 

DEPARTMENT OF VETERANS AFFAIRS 

BEFORE THE 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, 

COMMITTEE ON VETERANS' AFFAIRS 

U.S. HOUSE OF REPRESENTATIVES 

September 25,1997 

Introduction 

Mr. Chairman and Members of the Subcommittee, it is my pleasure to testify 

on behalfofthe Department of Veterans Affairs (VA) on the status of our 

information systems for the Year 2000. I am accompanied today by the 

Yeterans Health Administration (VHA) Chief Information Officer, Mr. R. 

Da\'id Albinson, and the Veterans Benefits Administration (VBA) Chief 

Information Officer, Mr. Newell E. Quinton. 

We are committed to ensuring VA's information systems will provide 

uninterrupted service supporting the full range of veterans benefits delivery 

and medical care for the Year 2000 and beyond. 

I would like to bring the Subcommittee up-to-date on steps we are taking and 

our progress in resolving Year 2000 problems. As I have previously testified, 

we are following the standardized, governmentwide Year 2000 best practices 

phases (assessment, renovation, validation and implementation) established 

by the Office of Management and Budget (OMB) in conjunction with the 

Federal CIO Council Subcommittee on Year 2000. 

Year 2000 Accountability and Monthlv Reporting Requirements 

As VA's CIO, I am responsible for overseeing and ensuring the completion of 

the Year 2000 project for all VA systems. The VBA CIO, VHA CIO, and 

senior information technology managers in the National Cemetery System 

(NCS) are responsible for developing specific plans and managing the projects 

within their respective jurisdictions. 

I have established detailed monthly internal reporting requirements to track 

our progress in addressing Year 2000 problems. This monthly report, 

modeled after OMB's governmentwide Year 2000 quarterly report, measures 

the progress of each VA administration for each of the established phases. 

Page 1 
52 

In addition to this formal reporting mechanism, the Administration-level 

ClO's and their Year 2000 program officials meet with me monthly to provide 

status reports addressing their successes and progress toward meeting the 

milestones presented in their plans. Monitoring monthly progress reports 

from each organization provides my office with early notice should an 

organization fall behind schedule. This early notice gives me the ability to 

recommend to VA's Chief Operating Officer, the Deputy Secretary, the 

necessary redirection and refocusing of appropriate resources to bring an 

organization back on schedule. 

Year 2000 Project Offices 

Both VBA and VIlA have Year 2000 Project Offices that report directly to 

their organization's CIO. These Project Offices provide for the planning, 

guidance, oversight and technical support for their organization's Year 2000 

efforts. 

I would like to take this opportunity to provide the Subcommittee an update 

on \'HA's and VBA's Year 2000 accomplishments. 

Veterans Health Administration 

\1iAPlan 

\ 1iA has prepared and widely distributed a detailed compliance plan, 

organized in accordance with the General Accounting Office (GAO) draft Year 

2000 best practices. We provided a copy of the plan to the subcommittee in 

June. In the plan, key responsibilities and accountability were assigned to 

the \1iA CIO and Associate CIOs, the Veterans Integrated Service Network 

(VISfl.1) ClOs, and VIlA healthcare facility management. Each of the 22 

VISN CIOs has the responsibility to develop and execute Year 2000 

compliance plans within their respective network. Many ofthe VISN CIOs 

have garnered management support, created Year 2000 workgroups, and 

identified key Year 2000 coordinators within their VISNs. The VISN ClOs 

have been provided guidance and reporting formats to generate consistent 

monthly statistics on both compliance status and Year 2000 costs. 

VIlA Year 2000 Milestones and Status 

VIlA's goal is to complete its assessment, including the nationwide 

assessment of biomedical equipment at VA medical facilities, by January 

1998. VIlA's plan is to complete any necessary renovation by July 1998, 

validation by January 1999 and implementation by October 1999. As of 

August 31. 1997, 30 percent of VIlA's mission-critical applications are 

Page 2 
68 

compliant. This percentage represents both the VISTA and VHA corporate 

system applications. 

VHA has assigned priorities to and scheduled the renovation ofVHA missioncritical systems. VISTA information system applications have been 

categorized according to their criticality to VHA's mission. To support the 

detailed VISTA application assessment process, VHA has acquired and is 

using an automated tool to support code analysis for both the national 

software applications and for locally developed software applications. VHA 

has begun to use this tool on some of its larger, more complex applications; 

code that will require renovation appears to be limited. As of August 31, 

1997,31 percent of VISTA applications have be assessed and 27 percent of 

VISTA applications are compliant or will be eliminated by the Year 2000. 

VHA is currently assessing all of its corporate information systems. System 

"owners" have been asked to determine the compliance status of their 

systems, and to establish schedules for completing the process if the systems 

are non-compliant. To date, 37 percent of the corporate systems have been 

assessed and 33 percent are either already compliant or will be eliminated by 

the Year 2000. 

VHA has completed its inventory of commercial-off-the-shelf (COTS) products 

for each hospital and has begun to determine the compliance of these 

products. My office, in conjunction with VHA and VBA, will share 

information on COTS provider status with all VA offices and use the federal 

CIO Council Subcommittee on Year 2000 Web page being established and 

maintained by the General Services Administration (GSA) on COTS 

products. 

Biomedical Equipment 

As I testified in June, the potential Year 2000 impact on biomedical 

equipment is a national issue, affecting both the private sector and federal 

health care communities. VA, along with other agencies and the private 

health care community, is a consumer of biomedical equipment; we do not 

regulate the industry. Let me bring the Subcommittee up-to-date on the 

specific actions VA is taking in the area of biomedical equipment. 

VHA formed the Medical Devices Integrated Product Team (MDIPT), a multidisciplinary oversight committee, to assist with identifying, inventorying, 

assessing and evaluating medical devices at risk. The MDIPT membership 

includes the following; 

Page 3 
." 

Deputy Director of Nuclear Medicine at Ann Arbor, MI, 

Biomedicai Engineer from VAMC Milwaukee, WI, 

Chief, Laboratory and Pathology Medicine at the Dallas V AMC, 

Cardiologist from the St. Louis VAMC, 

Director, Biomedical Engineering in HQ, and 

Chief of Surgery Service at the Salem V AMC. 

The team met in August to review and refine VHA's Year 2000 medical 

device plan. As a result, initial steps were validated and expanded; the 

model for assessing risk and for establishing priorities was validated and a 

comprehensive plan was produced. 

A subcommittee of the team created a database listing manufacturers of 

medical devices currently in use in the VHA. Experts from the team were 

consulted to ensure that manufacturers in all specialty areas were included" 

Members of the MDIPT rewrote the initial compliance status request letters 

using "lessons learned" from responses to the letters sent out in June 1997. 

A revised letter requesting more detailed information and plans from 

biomedical manufacturers was sent on September 10, 1997 to all 1,580 

manufacturers in the database. Vendors were asked to respond by October 3, 

1997; thus far, 135 responses have been received. VHA is reviewing those 

responses and will share the results with the Food and Drug Administration. 

Veterans Benefits Administration 

\"sA has made significant progress on its Year 2000 efforts in recent months. 

As of August 31, 1997,52 percent ofVBA's applications have been renovated 

and made Year 2000 compliant. Two payment applications, Chapter 31 

(Yocational Rehabilitation>, and the Reinstatement Program for Survivors 

(REPS) are compliant. Our Insurance application is on schedule with its 

renovation and will begin testing in February 1998. 

Overall Education system milestones are on track for completion within their 

projected timeframes and well before any application fail date. However, the 

projected completion date provided by our contractor shows a slippage for the 

Chapter 1606 redesign component of the Education system. This slippage 

has not jeopardized our overall completion date for making the Education 

system compliant. As for Loan Guaranty applications, task orders have been 

awarded or will be awarded to renovate noncompliant applications, insuring 

that all Loan Guaranty applications are compliant by their projected 

timeframes and before any fail date. VBA is developing a new application for 

real estate property management. The schedule has slipped but will not· 

impact the Year 2000 schedule because the existing application is coPlpliant. 

Page 4 
Let me address the Compensation and Pension application and its status. 

Forty-six percent ofthe Compensation and Pension modules are Year 2000 

compliant. However, Year 2000 work is competing with legislative program 

changes for Spina Bifida and incorporating Minimum Income for Widows, 

plus preparing for the annual cost of living adjustments. To minimize the 

risk that the complexities of implementing legislative changes would 

jeopardize Year 2000 efforts, VBA awarded a contract for renovation support 

of our Compensation and Pension application. This contract provides an 

automated Year 2000 conversion tool for the application and additional 

contractor support. 

We testified in JUDe that we awarded a task order for Oversight support. 

The Oversight Team completed their assessment ofVBA's Year 2000 effort. 

Their assessment substantiated what we knew all along: That VBA's Year 

2000 effort is on track and that schedules and resources are realistic. The 

Oversight team has made suggestions and recommendations that are being 

incorporated into VBA's Year 2000 Project plan. 

VBA has recently increased the amount of contractor support for their project 

managers, and will award task orders to support their software quality and 

testing efforts, as well as some loan guaranty renovations within the next few 

months. VBA's Oversight team will continue efforts to identify risk areas for 

VBA, including facility, telephone and non-information technology areas that 

could impact the delivery of benefits to our veterans. 

VBA has addressed all areas of potential Year 2000 problems. They have 

assessed all of their third party products and have budgeted for their 

replacements. They have acquired a compliant Honeywell 9000 platform for 

Year 2000 testing. As you know the Honeywell supports our Compensation, 

Pension, Education, and Vocational Rehabilitation applications. New, 

compliant IBM hardware and software is also being installed. In addition, 

VBA is working hard to resolve interface issues. Forty percent of their 

interfaces are Year 2000 compliant. 

VA's Austin Automation Center (AAC) 

The AAC provides VA-wide information technology support to all components 

within the Department. As of August 31, 1997,79 percent ofthe applications 

they support have been renovated and are Year 2000 compliant. The AAC 

plan is to have all systems renovated by September 1998, validated by 

October 1998, and fully implemented by September 1999. 

Page 5 
56 

VA working with Year 2000 Interagency efforts 

VA, VBA and VHA representatives are actively involved in several 

interagency efforts to find common solutions to Year 2000 issues and are 

representing VA's interest in several subgroups oftbe Federal CIO Council 

Subcommittee on Year 2000. Included are: 

• The biomedical equipment subgroup. This subgroup is chaired by the 

Department of Health and Human Services (HHS) and includes 

representatives from FDA, Nuclear Regulatory Commission, National 

Institutes of Health, DoD and each of the uniformed services. 

• The telecommunications subgroup chaired by GSA to address issues in 

voice and data communications systems. 

• The subgroup on building systems chaired by GSA to address issues 

related to the operation of buildings and facilities. 

• The Year 2000 best practices subgroup chaired by the Social Security 

Administration to share approaches to resolving Year 2000 problems. 

• The state and local subgroup dealing with state and F.ederal Year 2000 

issues. 

In addition, VHA staff meets monthly with staff from the Office of the 

Assistant Secretary of Defense for Health Affairs to pursue the identification 

of Year 2000 issues and solutions common to both organizations. 

Summary 

\'A organizations have prepared detailed systems inventories, and developed 

testing methodologies, individual project plans and contingencies. We are 

monitoring our progress for each application supporting our mission-critical 

systems. We are also monitoring such key elements as estimated lines-of· 

code, number of modules, operating systems and COTS packages. 

We will continue to work with the Federal CIO Council Subcommittee on the 

Year 2000 and continue sharing information among Federal agencies. We 

will continue to work with the HHS-chaired biomedical committee to resolve 

potential issues with biomedical equipment. 

Page 6 
57 

We are committed to ensuring that VA information systems will be ready for 

the coming millennium. VA information systems will continue to provide 

uninterrupted support to our programs and ensure that we deliver the 

highest quality benefits and medical care to our Nation's veterans and their 

families. I thank you for this opportunity to present our progreB8 in 

preparing for the Year 2000. Mr. AlbinBOn, Mr. Quinton and I would be 

happy to answer any questions you might have. 

Page 7 
58 

DEPAJITMENT OF HEALTH .. HUMAN SEIlVICES 

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59 

IHTBQQOCI'lON 

Good. aorninq. Mr. Cbair.an and ~. of the SuI:Icoaaitt... My 

..... ia Dr. 'l'h ...... Shope. I .. the Acting Dir.ctor. Diviaion of 

El.ctronic. and coaputer SCienc.. Office of SCience and 

T.chnolOCJY. center for Devicea and Radioloqical Health (CORH). 

Food and Drug AdainiatraUon (FDA). Having pravioualy t .. titied 

befora thi. ~ittaa at the June 26. 1997. hearinq. I .. 

pl ... ed to be her. today to provide intor.ation on the "Year 

2000· data i •• u ... it relat.. to ...sical d.vicea. Although FDA 

ha. not r.ceived any infor.ation .inca the pr.vioua hearinq to 

indicat. that thera vill be .iqnificant probl ... vith ...sical 

davie... I .. hera to a •• i.t the SuI:Icoaaittaa in ita .ffort. to 

.x .. in. the i •• u •• 

WHAT IS A MmXCAI. PINICJ!!' 

Accordinq to the d.finition in the Fadaral Food. Drug. and 

Co ••• tic Act (FD'C Act). a "d.vic." i.: 

an inatnlllent. apparatua. illplaaent ... chin •• contrivance. 

iaplant. in vitro r .. gent. or other .tailar or r.lated 

article. including any co.ponent. part or accea.ory. which 

i. intended for u.e in the diaqno.i. of di..... or other 

conditiona. or in the cur ••• itigation. tr .. taant. or 

prevention of di...... in .an or other aniaal.. or int.nded 

to affect the .tructura or any function of tha body and 

vhich c10aa not achiava ita pr iaary int.nded purposaa through 

chaaical action and which ia not d.pendent upon beinq 

_tabolized for tha achiav ... nt of ita priaary intandac1 

purpoa ... 

As thi. d.finition .ugg .. ta. .any differant typaa of product. are 

properly raqulated a • ...sical davicea. Medical davicea includa 

over 100.000 product. in aore than 1.700 cateqori... 'l'haaa 

product. raqulated by FDA a • ...sical davicea ranq. fro. .iapla 

everyday articl... .uch a. theraoaater.. tongue dapraaaor.. and 
60 

heatinq pads, to tha acra ccmplex davicee, auch as pa~ers, 

intrautarine davie .. , fatal stanta, and kidney dialyaie machin ... 

FDA ie r"ponsibla for protectiDg public health by belpirMJ to 

ensura that ...tical dsvicee ara .. fa and affective. FDA carri .. 

out its misaion by avaluatiDg new producta ~fora they ara 

marketed: assurinq quality control in aanuractura ~ 

inspection and snforcaaant activiti .. : and acnitorinq adver .. 

events in already markated producta, takiDg action, when 

necessary, to prsvent injury or death. A device aanufacturer 

must comply with all tha raguiraaenta of tha FD'C Act, includinq: 

establishaent registration and davice listinq, praaarkat raview, 

use of goad manufacturinq practicee (_), raportiDg advar .. 

events, and othsrs. 

As diverse as ...tical devic .. ara, so are tha ranga and 

complexity of probl_ wbich can ari .. from thair usa. Th_ 

probl .. s include .. chanical failura, faulty dasiqn, poor 

manufacturing quality, adverse effects of materials iaplanted in 

the body, iaproper maintenance/specifications, usar error, 

compromisad sterility/shslf life, and electromaqnatic 

intarferenca among davices. 

Any coaputer software which .. ata the legal dafinition of a 

medical davice is subject to applicabla FDA ...tical davica 

regulations. Madical devices which usa computers or software can 

take saveral foraa including: ~dad microchips which ara part 

of, or components of, devices: non-~ded software used with, 

or to control, devicea or record data from davices: or individual 

software programs which use or process patient data to reach a 

diagnosis, aid in therapy, or track donors and products. 

An issue which has been identified as varrantinq raview ie tha 

impact of ths 'Year 2000· on _ ...tical davice ccmputer syet_ 

and softwara applications. Tha .. producta could be i~cted by 
61 

the ·Year 2000· data probl .. only if th.y usa • data in th.ir 

algorithJl or calculatiollS. or in raoord k_pingl and a tvo-digit 

year to .... t wa. uaad in th.ir da.ilJll. Manufacturer. ot .uch 

producta are the only r.liabl. .ource of info .... tion a. to the 

details of the m.thods uaed in the progr ... ing and wh.th.r th.s. 

two conditions are .. t. While w. are in the process of r.viaving 

this issue. w. do not curr.ntly beli.v. that th.r. will be any 

aajor iapact on aedical d.vice sat.ty. 

Embedded Software 

Coaput.r software frequently is aabad4.d as a ·coapon.nt· ot 

devic ... i •••• sottware contained on a microchip to control 

device operation. BxlUlples ot such d.vices ar.: pa~ers. 

infusion pumps. ventilators. and aany oth.rs. It is unlik.ly 

that most ot these products would be iapacted by the ·Y.ar 2000· 

problem. Almost none of thes. d.vic.s require knowledg. of the 

currant date to operate sat ely and .ftectively. For .xample. 

pacemakers do not uae the current date in their operation. 

Hon-embedded Igftwora 

Non-embedded sottwar. is intended to be operated on a separate 

computer. oft.n a personal computer or work station. Such 

software d.vic.s aay be ua.d to enhance the operation of anoth.r 

devie. or devie.s and. further. aay ua. the two-digit y.ar 

format. It is possible that non-embedded software devie •• aay 

rely on the current date for proper operation and. further. aay 

use the two-digit year tormat. Such products might be att.cted 

by the ·Year 2000" date change. 

An example of non-embedded sottware is a computer program uaed to 

plan radiation therapy treatm.nts delivered using radioactiv. 

isotopes as the radiation source (teletherapy or brachytherapy). 

These treatments pos.ibly could be aftected it the coaputer 
62 

proqra. used to calculate the radiation dose para.eters uses only 

a two-digit year representation. Tbe calculation of the length 

of time since the source was last calibrated could be in error 

and thus lead to an incorrect treataent prescription. 

Other exa.ple. of non-embedded .oftware devices include: 

conversion of paceaaker telemetry data; conversion, trans.ission, 

or storage of medical images; off-line analysis of ECG data; 

digital analysis and graphical presentation of ECG data; 

calculation of rate response for a cardiac pacemaker; perfusion 

calculations for cardiopulmonary bypass; and calculation of bone 

fracture risk frca bone densito.etry data. While there is a 

chance that the two-digit format may affect the performance of 

these software devices, we believe that the ·Year 2000· risk will 

be mitigated through proactively working with manufacturers. 

Letter to Medical Deyice MAnufacturer. 

In light of our review of the i.pact of the ·Year 2000· on so.e 

medical device computer systeas and software applications, CORH 

sent a letter in July to 13,407 medical device manufacturers, 

8322 domestic manufacturers and 5,085 foreign manufacturers, to 

ensure that manufacturers address this issue and review both 

embedded and non-embedded software products. We reminded 

manufacturers that, in addition to potentially affecting the 

functioning of so.e devices, the two-digit year format also could 

affect computer-controlled design, production, or quality control 

processes. We requested that the manufacturers review the 

software used to determine if there is any risk. 

CORH recommended specific actions to ensure the continued safety 

and effectiveness of these devices. Por currently manufactured 

medical devices, manufacturers should conduct hazard and safety 

analyses to determine whether device performance could be 

affected by the ·Year 2000· date change. If these analyses show 
63 

that device .afety or effectivene •• could be affected. then 

appropriate steps should be taken to correct current production 

and to as.i.t custoaers who have purcha.ed .uch device.. For 

coaguter=gpotrp11e4 4 •• ign prpdugttgn and quality ggntrpl 

proce.u.. aanutacturer. should a •• ure that two-digit date 

formats or ca.putetions do not cause probl... beginning 

January 1. 2000. 

In our letter to industry. we r_inded aanufacturers that under 

the GNP regulation and the current Quality sy.t .. Regulation 

(which beca.e eft.ctive Jun. 1 and incorporat •• a •• t of check. 

and balances in manufacturer.' d .. ign proc ••••• to as.ure a sat •• 

effective finish.d product). th.y mu.t inv •• tigate and correct 

probl ... with .edical d.vices. This includ.s devic .. whicb fail 

to operate according to th.ir .pacifications because of 

inaccurate data r.cording and/or calculations. 

As a result of our l.tter. ws expect manufacturers who identify 

producte which have a date-r.lated problem which can posa a 

significant risk to the patient to take the n.ce.sary action to 

remedy the probl... This might include notitication ot d.vice 

purchasers so that their devics can be appropriately aoditied 

betore the ·Year 2000.· Manufactur.rs who discover a .ignificant 

risk pr .. ented by a date probl .. are required to notify CORK and 

take appropriate action. Again. w. do not anticipate any 

significant probl ... with individual .edical devices. however. we 

want to ensur. the continued safety and .ffectivenes. of th •• e 

devices. 

For ~ .edicel d.vice praaark.t .ua-i •• ion •• aanufacturer. of 

devices whose safe operation could be aff.cted by the ·Year 2000· 

date change will be required to daaon.trat. that the product. can 

perform date recording and computations properly. i •••• ·Year 

2000· compliant. 
COIICLUIOM 

Thank you, Mr. Chair.an, ror the opportunity to tell you about 

the iasue or ·Year 2000· and _ical devicea. Let _ a_ure you 

we at FDA take thia isaue vary aeriously aa _ do all probl ... 

which could attect the public health. We are ca.aitted to a 

scientitically sound regulatory environaent which will provide 

AIIet'icana with the best medical care. In the public intereat, 

FDA's commitaent to industry must be coupled with a reciprocal 

commi~nt: that _ical device tirma will meet hiqh standards in 

the desiqn, manutacture, and evaluation ot their products. We 

recoqnize that this can only be attained throuqh a collaborative 

ertort -- between FDA and industry -- qrounded in mutual reapect 

and reaponsibility. The protections attorded the AIIerican 

consUDer, and the benet its provided the medical device induatry, 

cannot be underestimated. 
65 

P08T-llBABlNG QUB8TION8 

CONCERNING THE 8EPl'EMBBB" 188'1 

BEARING ON YEAR lIOOO COMPUTBll COIIPLIANCB 

IN THE DBPAR'nIIBNT OF VBTEBAN8 AftI'AIB8 

FOR D. MARK CA'ILETl' 

ACl'ING A8818TANT 8BCRBTARY FOR MANAGEMENT 

DBPAR'nIIBNT OF VB'l'BRAN8 AftI'AIB8 

FROM THE HONORABLE LANB EVANS 

RANKING DEMOCRATIC MEMBEIl 

COIOllTl'BB ON VBTBRAN8' AftI'AIB8 

VA HOVSB OF RBPRBSBNTATIVB8 

QaudOD 11 '!'be ovenIPt team that VA oontnoted with iD JaDe to _ the ~ 01 it. J8U' lIOOO eftorU COIIclacied that "Mvwal 

U'eU 01 rUlE req1Iiriq ··D· ..... t .... U- wen DOUd." Ca:yo. 

icIeDtitJ' for the ~Uee the..,.aUlc rUlE U'eU iD order 01 

tbeir iaportaDoe1 Ca)'Ol1 u.o detail the ... )'011 will be taIdq to 

addreN u-e potaaUal trouble 8POtII'l 

Auwen 'lbe 8RA lDtemational (BRA> B._~ cooduded that 

eipificant ~ hal been nwle in the VetenmI 8eDeIit. AllmiDiltnlion 

(VBA) eftbrta to make it. applieatiOlli camp1iaut BRA did identifY IeVII1'IIl 

areu of riIb requiriDr VBA IDIID8pIIIAIDt attention. 

8RA identified the l'IlD09IItion of the Compenution and PeMlon (CloP) 

application aa a riak becaue VBA _tly awarded a contract for support of 

Year 2000 rIIIIOfttiOlli. BRA found that the IyftemIi development Itaft" at the 

Hm. 8eDeIit. DeliVIII'Y Center, wbich ia l'8IpOJI8ible for the CloP .)'Item, hal 

limited contract maJI8IIlIIUIIlt aperlence and 1ac1red detailed project plana. 

VBA hal since provided contract manapmant traiDiDg to key penonnel and 

a detailed plan ia under development by HiDea staff and will be completed in 

early November. 

8RA a1ao identi6ed the two CIIIlIzada for _ating two applieatlOlli for 

admiDiatnltive f\mcti0lli aa riIb becaue. they too, had ~y been 

awarded 

~ 

by VBA'.1yftemIi development staffin Austin, Tezaa. VBA 

in Austin hal COIlIz'IIdUIc manac-t aperieDce, bow_, 

the key ~ will be the Idu8l veudor plana and perfarmanoe. Both 

veDdon are beiDc doeely moaitond by the &.tin ltaft"to Elan! they are 

performiuc .. apected. 

Qautioa I: Your teRimoD)' aDd the teRimoD)' 01 GAO ' .... ice ... that 

the ~oa 01 the VRA'. Com.,... .. tioa aDd PeuioD appHcation 

appean to be a --.lor laanlle. Ca)'Ol1 ~ iD detail what the 

0ftI'IIiPt team '-Dladed iD thiI npnl, ad ODtIiDo what .... )'011 will be taIdq iD the _ t.m to acIcIn. thiI crWeal pnbIea1 

Auwen 8RA recommended that the systems development staff at Hm. 

obtain n-.ary contract ~ traiDiDg and develop detailed project 

plaDa. The _ation of the CloP application by the HiDes staffrepreaent. a 

hieh riak becaue the kDown leciIlative and maintenance c:baucea to the 

system diverted ~ £ram Year 2000 work. 
66 

VBA baa tabo aev81'lll1lte.,. to mitipte this riak. VBA baa awarded a 

c:ontnu:t to support Year 2000 l'8D098tion of the syatem. In addition, VBA 

baa provided c:ontnu:t ID8JI8IIlIIUIIlt tniniDg aDd a detailed plan ia UDder 

development by ume. staff to belp IIIIIIUn! timely completion of the Year 2000 

renovation. Pendinc lID,)' lDlI,jor chanpe to the ume. workload, we are 

confident this atrateeY will keep 118 on lCbeduJe. 

VBA baa made IligDffiCllDt ~ renovaq the C&P syatem in recant 

months aDd ita Year 2000 tdrorts ia on lICbedule. A. of September SO, 1997, 

52" of the C&P application JII'OII'IIIIl modullll are compliant. 

QaHU_ 8: It .. oar ~ that _ u.o.e application. 

witbbt the Ve&enu1IBeD.eftta ~ (VIlA) tbat have been 

_mpletely npoyNad lire DOt ~ ",..,,*,00" and tbenIore 

DOt year 1000 _pliaD.t. .. tbI8 aad~ cornet, and 1180, 

what .,.--taaa 01 the nmovated .,..... witbbt VBA lire laDy 

operatioaal Ai tbI8 poIat' 

App!icati0D8 that are _ated are Year 2000 compliant aDd operaticma1. 

These appljcatiODB are properly proceeBiDg datea for the Year 2000 aDd 

beyond. 

Auwen VBA ia not counting lID,)' application aa completing the 

implementation phaae, .. defined by the Office of Management aad Budget 

(OMB), until it ia actually nmning on hardware using a compliant operating 

syatem. For eumple, in the caee of the Vocaticma1 Rebabilitation 

application, it baa 00en renovated, validated and ia in production. However, 

the fully compliant operating syatem for the mainframe Honeywell system 

hardware will not be available for production until early in the second 

quarter of 1998. Preaently, we report to OMB that aiI percent ofVBA's 

applicatiODB have completed the implementation phase and are nmning 

using Year 2000 compliant operating syatems. The percentage complete for 

the implementation phase will grow 8ubetantially wben the remaining 

compliant operating syatems are installed. 

QaeIltiOD 4: Tbe ovenfcht t.m IndJcated that the VA baa yet to pDt 

toðer detaned _pliaD.ce plan. tor it. CompenaatioD and 

Penai_ II)'atem. Why lire DO ncb plana in ...... and when wiD IIUch 

• plan be pDt in place' 

Anawer: Plana have always been in place for the compliance of the 

compensation aDd pension syatem. However, the ovenight team pointed out 

that the eziating p1ana did not have the specificity -.ary for an effiJrt of 

this magnitude. Action ia being tabo to revisit theee p1ana aDd mesh them 

with the vendor's plan for renovation. VBA expecta those plans to be 

completed by early November. 

Queation 5: Tbe ovenfcht t.m baa pointed oat _pia 

~t probleauo witbbt the loan IUlU'IUlty prop't!Dl tbat have 

raUed CODCeI'D witbbt the qeney. Can yon briefly esplaiD W. 

problem and esplaiD the VA'. plan. to ad .... it' 

Auwen The oversight contnu:tor pointed out that Loan Guaranty 

applicatioDB are run on aev81'lll hardware platforms making lIlIIDIIgement of 

theee syatema aliihtly more complu. Multi-platform app1icati0D8 are not 

unuauai today and VBA baa an ezce1lent III8DIIg8IIl8Dt team with plans in 

place to IIUlII8P the renovation of noncompliant Loan Guaranty applications. 
6'1 

AI. .we teetified in September, tuk orden have been awarded to I'IIDIJYBte 

IU'nrompliant Loan Guaranty applicatioua, iDBurinc that all Loan Guaranty 

applicatiOllll are compliant by their prqjected time&ameII and befure any fail 

date. We al80 noted that VBA'. acheduJ.e for a II8W application for real estete 

property JDaD8PIII8Ilt had elipped but would DOt impact the Year 2000 

ec:hedule because the eziating application is compliant. 
"-dol_I' tie 

M. ' ...... 

B-2'18619 

Ncmmber 7. 1997 

The HooonbIe LaDe EvIns 

BIInIIIn8 MinorIt¥ Member 

Committee 011 Vetenn8' MrIirI 

HOUIt! of Representatives 

68 

SuIUect: Yetmoa Health AdmlnIItratIgn f)dII&y SyItegv!; Sqpe Prpcraw M"'e In 

Eputng Year 2000 Cggm!IarM:e but C'3!e!!en!et Bem!!p 

Dear Mr. Evan&: 

11d& letter reaponda to your October 10. 1997, letter. wbIcb aired • queetion ariIing 

from our September 26, 1997, te&IImony 011 Year 2000 InItIaIives at the Department 

of Vetenn8 MrIirI (VA).' Your questiOll 8IId our re&pOIlIIe follow. 

Your tatimony indicata that tM Vete1U1U Health Adnaini8tration (VHAJ htu 

fojkd to oompleu an inventory of til« eklJOtor. heatinIl. air oonditionin6. li6hting 

tlytdemtl, and di8atder recouery tlytdel1lll at iU hoBpitala. How critical II problon 

is tllia, and is tll«re Btill time to IIlldresII this problem within til« VHAF 

EnauriIIg Year 2000 compII&nce for fadIi1y-reJated system&, 8UCh as tOO. sy&tems 

controlling elevator, heatIn& air condIttOllln& ventllaUon, 8IId JISIttIng as well as the 

dI&aater recovery or backup systems for these product&, Is • crttIc&l problem for 

both pubHc 8IId private orpnlzat1on&. MaI!,y facIHtIes built or renovated wItIdn the 

Ia&t 20 years contain embedded computer systems that control, mOl\lt(]c, or a&1IiIIt in 

operatIol1&. MaI!,y of these systems could 1IIiiItunctI0II due to vuInenbIIIt¥ to the 

Year 2000 problem. For eumple, 011 J8IItwy I, 2000: 

• EIevator& could automatically park them&eIve& 011 the first floors, open tbeIr 

doors, 8IId shut down. 

• Heatin8 8IId air condItionIn8 WIIt& could &toP functioning property. 

• Card-entty aecurlt,y systems could cease to opente. 

• AutomatIc JISIttIng device& could fall to reacUva&e. 

Addre&sIng the fadJity-reJated systems problem Is eapecIaIIy crttIc&l for VIlA, 

bec&u&e It oversees 173 medlc&l centers, 376 outpaUen& dIDlc&, 133 nlll1lin8 home&, 

8IId 39 domiclllaries-a total of 721 facII1Uea. VIlA rec:oplI2e& the criUc&ItV of 

enaurIng Year 2000 compII&nce for 8UCh system8; Ita Year 2000 plan 8ta&e& that 

"fadI1ty-reJated system products are vitally Important to VIlA in providing quaI1ty 

healtlH:are aerv1ce.' 

VIlA baa made aome progreaa. Ita Year 2000 prqJect oftlce baa begun to develop • 

centtallzed Inventory for the facIIIty-reJated systems at Ita heaItlH:are facIIItIea. It 

eatabUshed • prqJect team, COIIIistIng of 20 technical ezpert& in various f&dIitie& 

system&, to pull together • II8t of fadIi1y-reIated sy&tems manufacturenl to be II&ed 

by VIlA as the starting point for this Inventory. The team baa drafted 8IId pI&ns to 

'YeterapR MJa1rB Cgmput.er SyIteqw; Ad10n tJpdenm Yet Much Work RepyInR To 

Rnn!yr Year 2000 CrtaIs (GAOII'-ADfD.97-174, Sept. 26, 1997). 

GAOr'~lR VIlA Year 2000 FacIIItlea s,atems 
69 

8-2'18619 

IIeIId IeUen to these manufacturers uIdng If tbeir products are Year 2000 c:ompIIant 

and wbat tbeIr plans are for 8CIdevInI compliance for IlClIICClIIIpIIII)'IIItem8 or 

prodactB. AI8o, VIlA's medical centen are CUI1'IlIItIy developin& 8IIinve1ltmy and 

IIB!III!IIng tbeIr facI11ty systems for Year 2000 compliance. FIn8IIy, VIlA Is &lao 

working with the CIO CouncIl's newb'-fonned Year 2000 BuIldInI s,.t.ems Subpoup 

011 facI11ty-reJated systems --. 

VHA, however, fIIces IOIIle m..- cIIIIlenaes-

• VIlA has. very short Ume frame to addreII the Year 2000 computing problem; 

there are 0IlIy 26 IIIOIIths rematnIn8 until J8II1W)' I, 2000. AccordIng to VIlA's 

Year 2000 prqJect JIIBIIa(Ier, VIlA JIUI,Y not complete Its lSI mMta of facI11tyrelated II)'IIItem8 by J8II1W)' 31, 19II8. 

• The prqJect JIIBIIa(Ier IncIIated tNt manufacturers JIUI,Y not promptly reIJIOIId to VHA. He further IncIIated tNt these manufacturers JIUI,Y not know If tbeIr 

products are Year 2000 compliant becaIIIIe IIOIIIe of the components tNt maIIe 

up the product JIUI,Y have been built by othen. As. result, manufacturers wIl1 

have to contact the reepoIIIlIbIe lIuppI1ers to determlne whether the components 

are Year 2000 compliant. 

• AccordIng to Its Year 2000 prqJect JIIBIIa(Ier, VIlA Is largely dependent upon the 

III&IIUfacturen to determine whether • Year 2000 problem er:Iats and how 811)' 

Year 2000 problemI wIl1 be corrected. Once manufacturer reI!IJIOIIIII!I are 

received and verI1Ied, VIlA must provlde them to Its VetenD8 lnfonnatlOll 

Service Networks (VJSN) and medical centen 10 tNt they can complete and 

Implement tbeir plans for Year 2000 compliance. 

• FIn8IIy, VIlA must Implement manufacturers' recommendat10111 for IICbievID8 

Year 2000 compliance of facI11ty systems and validate tNt an facI11ty-related 

II)'IIItem8 are Year 2000 compliant. AI8o, In coordInatlon with disaster recoYell' 

plans IIready In effect It its medical center8, VIlA must develop cooUngency 

plans !!pedfl~ deIIIped for Year 2000 failures and I!!TOI'II. 

We dI8cuIIIed • draft of tills report with VIlA ofIlclals, and tbeIr commentl have 

been Incorporated where 1IIJI)rOIIrlate. VIIA'I Year 2000 prqJect JIIBIIa(Ier SlId tNt 

the report ICCUlIteIy reflected VIlA's CII1l1IDt IIituItIoo for facI11ty-related .,sems. 

In 8IIIwer\ng tills question, we nMewed and anabzed II\!IlC)' documents referring 

to Year 2000 prqject&-IuCh .. VIIA'I Year 2000 Plan and VIlA's VISN Year 2000 

PIans-and Interviewed key VIlA Year 2000 oMdals. We conducted our work from 

October 20 through NCM!IIIber 6, 1997, In accordance with generaDy accepted 

pemment audItIn& SIandards. 

We are sending copies of tills report to the CIudnnan of the Bouse Committee 011 

VetenD8' A1raIrs, other IIItereIted COOIIIIlttees, and the AcUng Sec:retIl)' of VetenD8 

AtraIr8. CopIes wIl1 &lao be made avallable to other parties upon request. If you 

have 811)' quesdOlll concerning tills report, pIeue contact me It (202) 5l2-Q53 or 

Helen Lew, AsIIbtant DIrector, It (202) 512-9366. You JIUI,Y &lao e-mail us It 

wilkmBlle'li.aimd@gao.gou or lewh.aimd@gao.gou. 

i~2~ ~.1:~- DIrector, lnfonnatlOll ReIOurces Management 

(51l238) 

2 GA9'~lR VIlA Year 2000 FacIlitIes Systems 
(4 

-...9-

70 

DIPAIITMENT or IllALTH .. RUMAN SIIIIVICIS 

The Honorabl. I.ane BvanII ~ift9 Kinority -..ber ec-itt_ on v.ter .... ' Affain __ of Jlep~tet1v_ 

•• abift9ton, D.C. 30515-6335 

Dear 1Ir. BvanII. 

--- --"""-

_MIla.> 

Tbl8 18 in rae ........ to your l.ttera of ~ 1', october 10 and october 37, ltt7 re4Jardlft9 foll .......... lnto~tion to tbe JUne 36 and 8ap_ 35, 1tt7 _ittaa on OYanipt and 

Inv .. tig.tiOll8, ec-ittaa on v.terana' Aff.ira, _rlft98 OIl 

Year 3000 (nK) I .. u .. and Their I .... ct on the Dapart8ant of V.t.rena' Aff.in. Tbi. l.tt.r 18 raaponaiv. to the thraa 

l.tten r.f.nncad above •• the i .. u.. in your l.ttara .n interral.tacl. 

xQllTIrxClTIQM AKD CQRB'CTIQM or Y21 PRO'11l8 

Let u. bagin by ••• uring you tbet the Pood and Drug 

Adainl8tr.tion (Pm or the Aganoy), and partioularly tbe caatar for DaYi .... and Radiological aealth, taItaa tbe 18 .... of poa.lbl. Y3K probl_ in _ical device. vary aarioualy, and _ 

.r. ccma1ttacl to .ddra.a1ng .ffactiv.ly thi. _tt.r. we .l ..... dy have .ddraaaacl thl8 i .. u. with _icel device _nuf.ctur.n, •• outlina4 in our t •• t1llony, and _ will ba taking .dditional .t.pa, •• _t forth in .on d.te11 balov, to ••• ur. tbe contlnuacl .af.ty .nd .ffactiv.n ... of _ical daYi ..... 

Preaarkat nview .uthority i. the principal preventiv • ...mani .. Pm ..... to k •• p _ical device. that .n unaaf. or in.ffactiv. off the _rkat. unl ... explicitly _~ by the 

Ag8llCY, .inca 1976 ev.ry _ical device _t ba tbe .ubjact of • clearacl p~rk.t notification .ubai •• ion or an .pprovacl p~rk.t .pprov.l .pplication. Aa w. have t •• titiacl previo ... ly bafon the 8w.co.aitt_, tor new _ical device., Pm nov 18 r.viewing .ubal8.iona to ana=- that the producta can parforll data r.cording and ccmputetiona that will ba unaffactacl by the Y3K data chang •• 

In t.raa of product •• l ..... dy on the _rkat, Pm ._urea the •• f.ty and .ftactiven ••• ot _ical devi .... .ark.tad and _ 

in the Unitacl stat •• pri.ar11y through lnapactiona of _ical devic. _nuf.cturing t.ciliti.. and through _nitoring and 

a.aking corr.ction ot id.ntifiacl probl_ Which h.va occurred 
71 

Page 2 - The Honorable Lane EVans 

with already _rketed producte. FDA. inepects ..sical device 

tira. to deteraine co.pliance with the Federal Food, Drug, and 

Co ... tic (FDC) Act and FDA. requlatione, 1ncludil\9 the Quality Syst.. Regulation (previoualy the Good Kanutacturil\9 Practice 

(GNP) Regulation) (21 CPR 820). Under the Quality syst .. Regulation (21 CPR 820.100(a) (1», ..sical device aanutacturer. 

_t _ure and docuaent that their ..sical devicee pertora accordil\9 to speciticatione and otherwi .. coaply with GMPa. 

FDA believes its authority under the Quality Syst .. Regulation 

to require GNP coapliance is our clearest avenue to _ure that 

..sical device 80ttware and integrated ca.ponente are Y2K 

coapliant. Thia entails directing tira. to check and verity whether their producte present any potential Y2K prObl... and 

to bring potential probl... that have been identitied to the 

attention ot responsible parties at _nutacturing establis~ts. .e would, it necesaery, take regulatory action 

against tira. that tai~lto coaply with the Quality syst .. Regulation or other requir .. ents • 

• e have alerted the ..sical device induatry with the July 1997 

letter ot their obligation to identity and correct any prObl ... with their product.. IIOreover, in an ettort to clarity this 

authority, the Aqency plans to toll ow-up the letter with a loderal Register Notice that clearly direct. _nutacturer. to 

tultill their obligations under 21 CPR 820.100(a) (1) and that 

reiterates that it is the aanutacturer's existing legal responsibility to identity, to investigate and, when necesaery, 

to correct the cause ot product prObl ... , including those 

related to Y2K issues. The Aqency will suggest in this Notice a target schedule to coaplete this review. 

Section 519(t) ot the FDC Act, which _s added by the sate 

Medical o.vice Act ot 1990, requires _nutacturers to report certain corrections and r .. ovals ot ..sical devic_ undertaken 

by _nutacturers. Accordirigly, wha." aanutacturerlJ conduct 

their Y2K checks under the GNP Regulation, it probl... are tound and corrections _de -to reduce a risk to health posed by 

the device, or to remedy a violation ot this Act caused by the 

device which _y present· a risk to health, - these correctione 

would be reportable to FDA. under section 519(t)ot the FDC Act. 

This is a new provision whose regulations will beco.e ettective 

upon coapletion ot the adainistrative review procedures under 

the Paperwork Reduction Act ot 1995. The laderal Baai.ter 

Notice will underscore that any such potential Y2K prObl ... aust be identitied, corrected and reported to the Agency. 
72 

Paqe 3 - The Honorable Lane BVana 

L:rST or UDICAL rmrIcu 

Ba.ed on it. .cientific a .... aaent of the Y2K i •• ue, FDA 

believe. that there are very fev -.4ical device. dependent on calculation. which use date infor.ation for proper functioninq. There are .a.. qeneric types of device. which aay rai.. Y2K 

coapliance i •• ue., but FDA doe. not bave a li.t of -.4ical 

device. which bave been deterained to be Y21t COIIpliant or non-coapliant by industry sourcee. 

The only -.4ical device currently known to FDA to bave a Y2K 

probl_ which could illpact patient eafety i. one vendor'. 

radiation treat.ent planninq .y.~. That vendor currently i. 

developinq a .olution for the probl_ which will be aade 

available to purcha.ers. 

In your letter you .tate that, ·one of the .o.t .erious 

challenqe. to be addre .. ed involve. the Y2K coapliance of 

aachinery, .uch a. aedical device., which u._ ~ded chips.· OUr enqineerinq analy.i. indicate. that to create a probl_ the 

eabedded chip al.o au.t incorporate the u.e of a date, and that 

date au.t have been repre.ented u.inq a two diqit foraat for 

the year. It i. iaportant to note that this qualification qreatly reduce. the univer.e of affected product.. There are few aedical device. in which the u.e of a date i. critical for 

the device function. 

A .y.t_ which deteraine. a patient'. aqe for use in an alqoritba froa inforaation entered detailinq the patient'. birthday and the current date aay have Y2K coapliance i •• ue •• There are .everal cateqorie. of this type of device, .uch a. electrocardioqram interpretation proqrams or device. which 

provide diaqno.tic inforaation ba.ed on various paraaeter., includinq the aqe of the patient, which are provided a. input 

to the device. other .y.t ... with a potential for date-related 

probl ... are auxiliary or acce •• ory equipaent u.edwith 

pacemaker. to di.play or adju.t device function, but for which 

the critical functioninq of the device (the pacinq function) i. 

not date-dependent, and central nur.inq .tation. recordinq data 

froa aultiple patient. or coaputer-run .y.tems trackinq certain 

it ... in an operatinq room. At this time, FDA bas no inforaation which document. non-coapliance or probl ... with any of the.e type. of device •• 

CONSULTATION WITH THE VETBBANS' BUI,TH ADMINISTRATION 

Should the Veteran.' Health Adaini.tration (VHA) reque.t .pecific con.ultation or a •• i.tance froa FDA, we will provide whatever assistance that can be made available. VHA and FDA, 

alonq with representatives of other Federal aqencie., 
73 

Page 4 - The Honorable Lane EVan. 

participate on the Chief Inforaation Officers Council 

Subco.aittee on the Year 2000 workinq group on -.dical device. 

and .cientific equipaent. Thi. working group meet. regularly 

to addre •• i •• ue •• ucb a. you have rai.ed in your letters. 

One action under coneideration i. the creation of en Internet 

web.ite early in 1998 for di .... inatin; Y2K inforaation on -.dical device. provided voluntarily or through required 

report. by aanufacturer.. The webeite could be de.iqned to 

provide public acce •• to the Y2K coapliance .tatue of -.dical 

device. and .cientific equi~nt voluntarily provided by aanufacturer.. Thi. inforaation would be available to the 

Depart.ent of veteran.' Affair., a. well a. to other Federal 

and public health care facilitie •• 

We will continue to work with the public, induetry, and other 

intere.ted public health agencie. to en.ure that any potential Y2K probl... affecting medical device. are identified and 

corrected. We hope thi. inforaation i. helpful. If we aay be 

of any further a •• i.tance, plea.e let ue know~ 

Sincerely, 

Ae.ociate 

~~6~ co.ai •• ioner 

for Leqi.lative Affair. 

cc: The Honorable Bob stUllp Chairaan, Ca.aittee on veterane' Affair. 

o 
ISBN 0-16-056363-1 

90000 

9 801t60 563638