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MAY 1, 2001

Mr. Chairman and Members of the Committee,

Once again, it is my pleasure to appear before this Committee to discuss program activities of the Office of Emergency Preparedness (OEP). I am Dr. Robert Knouss, the Director of OEP.

Last year, I appeared here to discuss the General Accounting Office (GAO) report that had been recently released about the four specialized pharmaceutical caches used by our National Medical Response Teams (NMRTs).

These pharmaceutical stockpiles were designed to be deployed with our NMRTs in responding to a weapon of mass destruction (WMD) event and providing medical care to its victims. Three of the teams (West Coast, Central and East Coast) can be deployed anywhere in the country. The Mid-Atlantic team is committed to responding to incidents in the Washington, D.C. metropolitan area, including the U.S. Capitol. The stockpiles associated with each of these four teams contain specialized pharmaceuticals to treat up to 5,000 victims of a chemical exposure to nerve agents such as sarin and VX; vesicants, such as mustard gas; and pulmonary agents such as phosgene. In addition, each stockpile has medicines to provide the initial care at the scene for these victims, stabilizing them medically until they arrive at a health care facility.

In the original report on the status of the stockpiles, GAO raised concerns about the manner in which the caches were managed and the oversight provided by OEP. We have appreciated GAO's comments, suggestions and insights, and have been working diligently with the Department of Veterans Affairs (VA) to correct problems, improve internal controls and tighten OEP management practices.

We have made a great deal of progress in these areas. We have assured appropriate storage and physical security of the stockpiles; strengthened internal controls, including 100 percent inventories of all of the caches, as well as independent reviews; established regular communications with the VA; conducted risk assessments; ensured regular and recurring management oversight by OEP; approved operational plans for each location; and ensured that an approved, updated inventory requirement list is maintained.

However, we still have a number of things to do. GAO recently completed its final report on the stockpiles. We appreciate that they noted the significant progress that we have made to bring these caches into compliance with all regulations and appropriate internal control procedures.

In its recently released report, GAO commented on some progress that still needed to be made, and made some recommendations to OEP. At this time, I would like to address these recommendations and discuss what we are still doing to complete the activities, to ensure that the stockpiles meet all requirements and to be able to deploy them in a timely and effective response.

Within the next month or two, we will be moving our Central cache to a new location, in order to ensure that appropriate physical security and safeguards are in place, as well as to ensure that temperature controls are maintained. This action will mitigate problems that have occurred at the current location with some of the cache being exposed to higher than acceptable temperatures. We do not believe that the observed temperature fluctuation degraded the effectiveness of the pharmaceuticals. However, we will be replacing all of the affected drugs when the cache is moved. While the GAO report notes that the items that were exposed to the higher temperature may not be effective in the event of a terrorist incident, we would note that we have three other caches that can be moved if necessary.

GAO noted that OEP lacked detailed written inventory procedures necessary to help ensure overall reliability of inventory records. They also said that OEP had not updated its requirements list for significant increases to its stockpile. Both of these issues have subsequently been addressed. Detailed inventory procedures and operating plans have been approved for each cache location and detailed requirements lists have been updated and transmitted to the VA. I would add that this was, in large part, a procedural matter in that plans that had been approved lacked solely the final signature.

GAO also stated that there were no published discrepancy rates, and that in the absence of this information, there was no data with which to measure the inventory results. Error rates have been discussed with the VA. We established a zero tolerance error rate for controlled substances and an error rate of three to five percent for low cost items.

Finally, GAO expressed concern about the lack of training for VA personnel involved in stockpile management. Later this month, we will be bringing VA personnel, in addition to other Public Health Service teams to the Noble Training Center in Anniston, AL, to conduct training, in conjunction with CDC, on deploying and distributing the National Pharmaceutical Stockpile. We will be providing Oracle software training to VA staff for managing cache inventories. And we recently provided HAZMAT training for VA staff at the National Disaster Medical System conference that was held last month in Dallas.

Mr. Chairman, OEP has been working diligently to ensure that all internal control procedures are met, that the stockpiles are current and adequately safeguarded, and that we can deploy them quickly. It is my sincere hope that these stockpiles will never have to be used, but we will continue to assure our readiness to respond, if necessary.

That concludes my prepared remarks. I would be pleased to answer any questions you may have.

Last revised: May 30, 2001