Entities' experiences and perceptions of reporting the theft, loss, or release of select agents or toxins to CDC
- Collection:
- Health Policy and Services Research
- Contributor(s):
- United States. Department of Health and Human Services. Office of Inspector General. Office of Evaluation and Inspections, issuing body.
- Publication:
- [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, February 2018
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Biohazard Release Mandatory Reporting Toxins, Biological Laboratories Organizational Culture Safety Theft Humans United States United States. Department of Health and Human Services. Centers for Disease Control and Prevention (U.S.)
- Genre(s):
- Technical Report
- Abstract:
- In recent years, Congress and the media have devoted attention to several events at laboratories involving the theft, loss, or release of select agents or toxins. Select agents and toxins are bacteria, viruses, fungi, or other microorganisms that have the potential to pose severe threats to health, such as smallpox, Ebola, or anthrax. Entities registered to possess, use, and transfer select agents and toxins must report all events that involve a potential theft, loss, or release (TLR events) to the Federal Select Agent Program (FSAP). The Centers for Disease Control and Prevention's (CDC) Division of Select Agents and Toxins (DSAT) provides oversight of entities that are registered with the Federal Select Agents Program (FSAP) to possess, use, and/or transfer select agents and/or toxins that pose a severe risk to public health and safety. In FSAP terminology, a "theft" is the unauthorized removal of a select agent or toxin. A "loss" is a failure to account for a select agent or toxin. A "release" is an occupational exposure or discharge of a select agent or toxin outside of the primary barriers of a biocontainment area. CDC requested that the Department of Health and Human Services' (HHS) Office of Inspector General (OIG) collect information on entities' experiences and perceptions of reporting TLR events. The request was spurred by our May 2017 report on CDC's oversight of the FSAP, which found that almost 3 of every 4 entities (201 of 275) had reported no TLR events over a 3-year period (from 2013 through 2015). Although the number of TLR events reported to the FSAP has increased over time--which CDC attributes to entities' becoming more aware of the reporting requirements--CDC has expressed concern that entities with no reported TLR events for multiple years may be underreporting them and may pose more of a risk than entities that regularly report TLR events. This report describes the extent to which sampled entities have reported TLR events; their perceptions of obstacles to and benefits of reporting TLR events; and the actions that CDC and entities can take to ensure reporting of all required events. We did not independently verify the accuracy or validity of entities' statements. These comments reflect entities' experiences and perceptions of the reporting of TLR events. Including these comments in this report does not indicate that OIG endorses these statements. This report is the second of three HHS OIG reports on CDC's oversight of entities registered with the FSAP. The first report found that while CDC generally met its inspection goals for the FSAP, opportunities exist to strengthen its oversight.6 The third report will assess CDC's oversight of entities' compliance with the requirements at 42 CFR subsection 73.9(a)(6) regarding annual internal inspections.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (29 pages))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 101737987 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/101737987