Food and Drug Administration:

Insufficient Planning for Field Laboratory Consolidation Decisions

HRD-88-21: Published: Dec 4, 1987. Publicly Released: Jan 5, 1988.

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In response to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) plans to close or consolidate its field laboratories, particularly the: (1) criteria it used to determine which of its laboratories to close or merge; (2) cost-effectiveness of the closings; and (3) impact of the closings on FDA ability to carry out its functions.

GAO found that FDA: (1) plans to close five of its field laboratories in order to reduce excess capacity; (2) did not consider any cost-effective alternatives to closure or the impact of closure on its future needs; (3) overstated some of the costs and savings it would realize from the proposed closure, and understated or omitted others; and (4) did not take into consideration possible increases in future shipping costs, sample transportation times, and laboratory processing times in making its decision.

Recommendations for Executive Action

  1. Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    Recommendation: The Secretary of Health and Human Services should direct the Commissioner, FDA, to defer decisions regarding laboratory closure/consolidation until FDA has developed a long-range plan based on its future program needs. This plan should identify the extent to which vacant work stations may be in excess of current and future laboratory needs. If a significant amount of unused and unneeded laboratory capacity is identified, the Secretary should direct the Commissioner to explore the full range of alternatives available to deal with the problem.

    Agency Affected: Department of Health and Human Services

  2. Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    Recommendation: In considering the closure/consolidation option, the Secretary of Health and Human Services should direct the Commissioner, FDA, to identify the laboratories for closure/consolidation by evaluating all appropriate factors, including forecasts of future analytical needs, to ensure that the resulting laboratory network can support the FDA consumer protection mandate in a timely, cost-effective manner.

    Agency Affected: Department of Health and Human Services

  3. Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

    Recommendation: In considering the closure/consolidation, the Secretary of Health and Human Services should direct the Commissioner, FDA, to develop accurate and comprehensive costs/savings analyses detailing the economic consequences of closures decisions.

    Agency Affected: Department of Health and Human Services

 

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