Combating Terrorism:

Accountability Over Medical Supplies Needs Further Improvement

GAO-01-463: Published: Mar 30, 2001. Publicly Released: May 1, 2001.

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This report updates the status of corrective measures taken by federal agencies to address internal control weaknesses that could affect the United States' ability to effectively respond to chemical or biological terrorist attacks. GAO, which cited these weaknesses in 1999, found that the agencies have significantly improved accountability over the medical supplies needed to treat victims of chemical or biological terrorism. However, ensuring that supplies are current, accounted for, and readily available depends in large part on successful collaboration with other entities. Until the Centers for Disease Control and Prevention (CDC) and the Office for Emergency Preparedness (OEP) formalize ad hoc arrangements with other entities covering the storage, management, stock rotation, and transporting of supplies, they run the risk that, in the event of a chemical or biological attack, the appropriate supplies will be unavailable. Also, unless the agencies' inventory requirements lists are up-to-date and reflect their own identified needs, the agencies cannot guarantee that they have the supplies on hand to fulfill their mission.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: On April 4, 2001, CDC's agent, VA, executed a 1-year contract with a pharmaceutical wholesaler (with options to renew for 2 additional years) for the storage, management, and rotation of medical supplies. The contract ensured that fresh supplies would be kept on hand, and cost savings would be realized through credits to CDC for the return, redistribution and replacement of certain pharmaceutical supplies within expiration dating. Also, the Strategic National Stockpile (SNS) Program, through its contracting agent, VA, established written agreements with all contracting partners responsible for the transportation of critical medical supplies maintained by the SNS Program. These agreements were signed between October 2002, and June 2004. According to a program official, the contracts typically extend anywhere from 1 to 10 years, with up to 7 option years.

    Recommendation: To minimize risks associated with partnering with private-sector companies and other entities in managing the National Pharmaceutical Stockpile, the Secretary of Health and Human Services should require the Director of the Centers for Disease Control and Prevention to execute written agreements as soon as possible with all CDC's partners covering the storage, management, stock rotation and transporting of medical supplies designated for treatment of biological or chemical terrorism victims.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Implemented

    Comments: In May 2001, CDC issued standard operating procedures (SOPs) for maintaining National Pharmaceutical Stockpile program assets at storage sites. The SOPs include guidance on topics such as security, quality assurance, access, maintenance, and mobilization.

    Recommendation: To minimize risks associated with partnering with private-sector companies and other entities in managing the National Pharmaceutical Stockpile, the Secretary of Health and Human Services should require the Director of the Centers for Disease Control and Prevention to issue written guidance on security to private warehouses that store stockpiles, on such issues as granting access to the wholesale distributor for stock rotation.

    Agency Affected: Department of Health and Human Services

  3. Status: Closed - Implemented

    Comments: Since the completion of GAO's field work, CDC has installed fences at the locations where stockpiles are currently stored.

    Recommendation: To minimize risks associated with partnering with private-sector companies and other entities in managing the National Pharmaceutical Stockpile, the Secretary of Health and Human Services should require the Director of the Centers for Disease Control and Prevention to, to the extent practical, install proper fencing prior to placing inventories at storage locations.

    Agency Affected: Department of Health and Human Services

  4. Status: Closed - Implemented

    Comments: On February 27, 2001, OEP developed, approved, and issued an inventory requirements list of pharmaceutical and medical supplies that are to be kept on hand in its stockpiles for treating victims of chemical or biological terrorist attacks.

    Recommendation: To improve accountability over medical supplies in its inventory, the Secretary of Health and Human Services should require the Director of the Office of Emergency Preparedness to finalize, approve, and issue an inventory requirements list.

    Agency Affected: Department of Health and Human Services

  5. Status: Closed - Implemented

    Comments: The medical supplies were moved to a new location in June 2001. The storage cage in which the controlled substances are stored is equipped with intrusion alarms, motion detectors, and access monitoring systems.

    Recommendation: To improve accountability over medical supplies in its inventory, the Secretary of Health and Human Services should require the Director of the Office of Emergency Preparedness to improve physical security at its central location to comply with Drug Enforcement Administration regulations, or move the supplies as soon as possible to a location that meets these requirements.

    Agency Affected: Department of Health and Human Services

  6. Status: Closed - Implemented

    Comments: OEP and VA agreed that one complete annual inventory will be performed at each storage location. Furthermore, as expired items are replaced, the storage unit affected will be counted and reconciled to system data. OEP established a tolerable error rate of 3-5 percent for low-cost items, and items for which a replacement is readily available. However, OEP established a zero tolerance for errors related to controlled substances.

    Recommendation: To improve accountability over medical supplies in its inventory, the Secretary of Health and Human Services should require the Director of the Office of Emergency Preparedness to issue a written policy on the frequency of inventory counts and acceptable discrepancy rates.

    Agency Affected: Department of Health and Human Services

  7. Status: Closed - Implemented

    Comments: On March 8, 2001, OEP approved and issued to VA the national and local operating plans for immediate implementation. The plans address key responsibilities of VA personnel for the procurement, storage, management, and deployment of the supplies, including the amount of space and level of security to be provided at various warehouse sites.

    Recommendation: To improve accountability over medical supplies in its inventory, the Secretary of Health and Human Services should require the Director of the Office of Emergency Preparedness to finalize and implement approved national and local operating plans addressing the Department of Veterans Affairs' (VA) responsibilities for the procurement, storage, management, and deployment of OEP's stockpiles.

    Agency Affected: Department of Health and Human Services

  8. Status: Closed - Implemented

    Comments: On March 8, 2001, OEP approved and issued to VA the national and local operating plans. Subsequently, OEP, its logistical contractor, and the VA emergency pharmacy staff have provided related training to VA staff. Periodic quality reviews are being conducted during monthly teleconference calls and on-site audits of supply inventories and management.

    Recommendation: To improve accountability over medical supplies in its inventory, the Secretary of Health and Human Services should require the Director of the Office of Emergency Preparedness to train VA personnel and conduct periodic quality control reviews to ensure that national and local operating plans are followed.

    Agency Affected: Department of Health and Human Services

  9. Status: Closed - Implemented

    Comments: Samples of temperature stressed drugs were shipped to FDA for potency testing on June 12, 2001.

    Recommendation: To ensure the effectiveness of medical supplies in its inventory, the Secretary of Health and Human Services should require the Director of the Office of Emergency Preparedness to immediately contact the Food and Drug Administration or the pharmaceutical and medical supply manufacturers of items stored at its central location to determine the impact of items exposed to extreme temperatures.

    Agency Affected: Department of Health and Human Services

  10. Status: Closed - Implemented

    Comments: VA ordered drugs to replace temperature stressed drugs including diazepam, Mark I auto-injectors, and ciprofloxin.

    Recommendation: To ensure the effectiveness of medical supplies in its inventory, the Secretary of Health and Human Services should require the Director of the Office of Emergency Preparedness to replace those items deemed no longer usable.

    Agency Affected: Department of Health and Human Services

  11. Status: Closed - Implemented

    Comments: In June 2001, OEP moved the supplies in the central location to a new air-conditioned facility with temperature monitoring systems.

    Recommendation: To ensure the effectiveness of medical supplies in its inventory, the Secretary of Health and Human Services should require the Director of the Office of Emergency Preparedness to either add environmental controls to the current location or move the supplies as soon as possible to a climate controlled space.

    Agency Affected: Department of Health and Human Services

  12. Status: Closed - Implemented

    Comments: According to correspondence from the DOD OIG, the Marine Corps Systems Command transferred $454,000 of fiscal year 2001 O&M funds on June 26, 2001, to cover identified deficiencies in the Chemical Biological Incident Response Force (CBIRF) AMAL configuration. CBIRF filled the deficiencies by October 1, 2001.

    Recommendation: To ensure that medical supplies on hand reflect those identified as being needed to respond to a chemical or biological terrorism incident, the Commandant of the Marine Corps should direct the Marine Corps Systems Command to program funding and complete the fielding plan for the Chemical Biological Incident Response Force specific authorized medical allowance list and require the Commanding Officer of the Chemical Biological Incident Response Force to adjust its stock levels to conform with the authorized medical allowance list.

    Agency Affected: Department of Defense: United States Marine Corps

  13. Status: Closed - Implemented

    Comments: According to correspondence from the DOD IG, Marine Corps Systems Command transferred $454,000 of fiscal year 2001 O&M funds to the Marine Expedition Fund on June 26, 2001, to cover identified deficiencies in the CBIRF AMAL configuration. As of January 8, 2002, CBIRF stock levels conformed to the authorized medical allowance list. Also, as of this date, CBIRF removed or replaced all expired items.

    Recommendation: To ensure that medical supplies on hand reflect those identified as being needed to respond to a chemical or biological terrorism incident, the Commandant of the Marine Corps should direct the Marine Corps Systems Command to program funding and complete the fielding plan for the Chemical Biological Incident Response Force specific authorized medical allowance list and require the Commanding Officer of the Chemical Biological Incident Response Force to remove expired items from its stock and replace them with current pharmaceutical and medical supplies.

    Agency Affected: Department of Defense: United States Marine Corps

 

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