“More and more, it’s impossible to keep track of hundreds of thousands of lines of documentation and review notes” using paper, said Fred Farmer, information technology program director in the FDA’s Office of the Chief Information Officer. Instead, the FDA relies on specialized scientific computing, which has to be reliable to avoid any costly breakdowns in the review process. And since the agency began consolidating its information technology management into a single office 18 months ago, that mission has gotten easier. The multiple centers and offices mostly still handle the information in different ways, using different systems to store and disseminate that information.
But now, the FDA’s information technology services will be increasingly coordinated by the CIO and the new Office of IT Shared Services, in Rockville, Md., improving efficiency and reliability and boosting the capability of FDA offices to receive, handle and store submissions electronically.
The advantages of this IT consolidation and sharing can be seen, for instance, in the agency’s enhanced regulation of products that combine a medical device and a drug. Consider a stent, a stainless steel tube that is inserted into a coronary artery to keep the artery from narrowing and the blood flowing from the heart. The tube is coated with a drug that is released slowly to limit growth of normal tissue that can start narrowing the artery again. One FDA office may review the drug component of the stent, while another may review the hardware — and the central IT office has aligned the information systems so it can better coordinate the product review for such new combination products.
The IT consolidation and sharing effort started out mainly as a way to accommodate tighter budgets — the agency underwent a 15 percent IT budget cut in 2004. The IT Shared Services unit took another 7.5 percent budget cut in 2005. Staff cuts were accomplished through attrition, with no jobs lost. But the “opportunity to do more with less” improved how each of the seven FDA centers does its job, Farmer said.
The IT consolidation has benefited not only the product review process, but also other operations at FDA. The shared services office also supports the Employee Resource and Information Center, an FDA call center and Internet Web portal, which allow employees to get quick answers to a variety of personnel-related questions or to seek help for computer-related problems.
The reorganization is expected to save FDA $10 million over five years.
The IT consolidation was part of a broader FDA overhaul that also consolidated acquisitions, financial and other administrative operations. Gregory Doyle, chief of FDA’s Office of Shared Services, said that conversion to shared IT and other services has achieved “a significant amount of success — probably exceeding any expectations the leadership might have had.”
For example, a computer upgrade no longer relies on an office’s systems support staff learning about a software upgrade and coming up with the money on its own to do the upgrade, Farmer said. Now, with computers networked and control consolidated, an upgrade is automatically applied to all computers, often remotely.
Also, the level of IT service at any given FDA office is not based on the size of that office’s budget. Rather, a common level of service is available throughout the agency.
Model for government
The Office of Management and Budget has given FDA high praise for its consolidation efforts. A key to the agency’s success in this transition to shared services was its communications with staff and other stakeholders to explain “the decision itself, why it was made and that it would be given the appropriate resources and focus,” said Karen Evans, OMB administrator of e-government and information technology. Important factors included “selecting a hard implementation date and never faltering from it, having an effective communication plan, and maintaining realistic expectations,” she told Federal Times.
The FDA picked a conversion team staffed with experienced individuals “energized by change,” Evans said, chose leaders with shared services familiarity from other agencies or companies, and selected a contractor, Booz Allen Hamilton, which had experience in handling other IT consolidation projects. In this case, the contractor served in an advisory capacity, and FDA managed the effort.
FDA officials say they think the reorganization has made the agency more streamlined and competitive in taking on any bids from contractors to outsource the agency’s administrative functions.
“Had we not gone through this conversion, I don’t know how we would have made it,” he said, referring to the budget and staffing pressures.
“We feel a lot more competent,” regarding any outsourcing threat or other threat, he added.
Making it happen
In charting its course to consolidation, FDA started with an enterprise architecture, which is an IT blueprint that helps managers understand how to realign and connect IT systems to manage information more effectively. The architecture laid out the plan for the new operation, including the process, people and business model, and a plan for further cost savings, said Gary Washington, FDA’s chief enterprise architect.
The effort has earned the agency high marks from the Government Accountability Office, which assesses how well agencies manage IT using enterprise architecture. GAO scores agencies on a scale of 1 to 5, with 1 indicating that an agency is just starting to develop the architecture and 5 meaning that it is making full use of the architecture.
GAO gives FDA a 3 on its scorecard, well above the score of 1 most agencies get, Washington said. Signs of the FDA architecture’s progress: It has business, applications, security and technical data; and it integrates capital planning. Further steps for FDA will involve establishing targets for how IT supports the agency’s business and fashioning a transition for getting there. All this will have to be put on the Internet, Washington said.
Educating and training IT employees in the new concept was crucial for its success. In October 2003, five town hall-style meetings, with 20 to 30 employees at each meeting, were held at a Rockville, Md., facility to explain the conversion goals and process.
Because FDA employees were engaged in the design and implementation of the conversion, they felt ownership, OMB’s Evans said. And since then, both IT employees and their customers — the FDA centers being served — have been surveyed to assess the consolidation’s performance.
“We wanted to make sure that everyone understood what we wanted to do, because any kind of changed management requires the participation of our employees,” said Jeff Cooper, director of the Office of IT Shared Services. “Any time that you undergo a major change, there is a certain amount of angst.”
Despite some resistance, employees before long began to show enthusiasm for the new approach, Cooper said. Unions, too — initially concerned whether the change was in the best interest of employees — seemed to realize that the efficiencies promised by the consolidation meant that “the shared services organization really positioned us to be competitive with anybody else,” Cooper said.
Other challenges included trying to meet the high expectations of the FDA units being served, and dealing with the sense of loss of power and control by the units ceding their IT people to the new Office of IT Shared Services. Now, the biggest remaining challenge is developing common standard practices such as with the purchase of personal computers, Cooper said. “Any time you take a decentralized organization and develop a centralized organization, you have different standards, and the big challenge is developing common standards,” he said.
But benefits from the conversion are mounting. Portfolio management — deciding where to spend IT money across 31 investment areas — has been accomplished.
“IT is helping people look across the lines of their organizations,” said Farmer. “Let the drug reviewers focus on the drug review process, not document management.”
Autor: Al Karr
Quelle: Federal Times, 05.04.2005
