Biological Laboratories: Design and Implementation Considerations for Safety Reporting Systems
GAO-10-850
Published: Sep 10, 2010. Publicly Released: Oct 12, 2010.
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Highlights
As the number of biological labs increases, so too do the safety risks for lab workers. Data on these risks--collected through a safety reporting system (SRS) from reports of hazards, incidents, and accidents--can support safety efforts. However, no such system exists for all biological labs, and a limited system--managed by the Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS)--applies to only a subset of these labs. While a national SRS has been proposed, design and implementation are complex. In this context, GAO was asked to identify lessons from (1) the literature and (2) case studies; and to apply those lessons to (3) assess CDC and APHIS's theft, loss, or release (TLR) system for select agents, such as anthrax, and (4) suggest design and implementation considerations for a labwide SRS. To do its work, GAO analyzed SRS literature; conducted case studies of SRSs in aviation, commercial nuclear, and health care industries; and interviewed agency officials and biosafety specialists.
Recommendations
Matter for Congressional Consideration
| Matter | Status | Comments |
|---|---|---|
| In developing legislation for a national reporting system for the biological laboratory community, Congress may wish to consider provisions for the agency it designates as responsible for the system to take into account the following in design and implementation: (1) including stakeholders in setting system goals; (2) assessing labs' organizational culture to guide design and implementation decisions; (3) making reporting voluntary, with open-reporting formats that allow workers to report events in their own words and that can be submitted by all workers in a variety of modes (Web or postal), with the option to report to either an internal or external entity; (4) incorporating strong reporter protections, data deidentification measures, and other incentives for reporting; (5) developing feedback mechanisms and an industry-level entity for disseminating safety data and safety recommendations across the lab community; and (6) ensuring ongoing monitoring and evaluation of the safety reporting system and safety culture. | Congress has not taken action on this recommendation. |
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Animal and Plant Health Inspection Service | To improve the system for reporting the theft, loss, and release of select agents, the Centers for Disease Control and Prevention and Animal and Plant Health Inspection Service Select Agent Program, in coordination with other relevant agencies, should consider the following changes to their system: (1) lowering the threshold of event reporting to maximize collection of information that can help identify systemic safety issues, (2) offering limited immunity protections to encourage reporting, and (3) developing mechanisms for sharing safety data for international lab safety improvement efforts and processes for identifying reporting gaps and system evaluation to support targeted outreach and system modification. |
Regarding executive recommendation (1)and(3): CDC/ APHIS (USDA) report that they have improved the TLR system by developing mechanisms and processes as GAO recommended for using safety data for safety improvement efforts and for identifying gaps to support targeted outreach. 1. They presented sessions in two National Select Agent Workshops October 2010 and May 2011 2. They analyzed data from APHIS/CDC Form 3 for the Report of Theft, Loss or Release of Select Agents and Toxins, communicating it to the biosafety community both through an October, 2010 meeting of the American Biological Safety Association and through a scheduled publication. 3. They are taking the lead with Canadas WHO Collaborating Center to pilot in 2012 an international database of biosafety reports of lab exposures and lab acquired infections (LAIs) in order to provide an evidence base for best practices, trend analysis, and recommendations to reduce exposures and LAIs. CDC/APHIS formal analysis of the safety data they collect and their use of it in outreach to the Select Agent community and beyond to the US Bio-safety community and to the international community will facilitate more rapid safety reporting system modification.
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| Centers for Disease Control and Prevention | To improve the system for reporting the theft, loss, and release of select agents, the Centers for Disease Control and Prevention and Animal and Plant Health Inspection Service Select Agent Program, in coordination with other relevant agencies, should consider the following changes to their system: (1) lowering the threshold of event reporting to maximize collection of information that can help identify systemic safety issues, (2) offering limited immunity protections to encourage reporting, and (3) developing mechanisms for sharing safety data for international lab safety improvement efforts and processes for identifying reporting gaps and system evaluation to support targeted outreach and system modification. |
Regarding recommendation (1)(3):CDC/ APHIS report that they have developed mechanisms and processes as GAO recommended for using safety data for safety improvement efforts and for identifying gaps to support targeted outreach. 1. They presented sessions in two National Select Agent Workshops October 2010 and May 2011 2. They analyzed data from APHIS/CDC Form 3 for the Report of Theft, Loss or Release of Select Agents and Toxins, communicating it to the biosafety community both through an October, 2010 meeting of the American Biological Safety Association and through a scheduled publication. 3. They are taking the lead with Canadas WHO collaborating Center to pilot in 2012 an international database of biosafety reports of lab exposures and lab acquired infections (LAIs) in order to provide an evidence base for best practices, trend analysis, and recommendations to reduce exposures and LAIs. CDC/APHIS formal analysis of the safety data they collect and their use of it in outreach to the Select Agent community and beyond to the US Bio-safety community and to the international community will facilitate more rapid safety system modification.
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Biological researchIndustrial accidentsIndustrial engineeringIndustrial facilitiesIndustrial safetyLaboratoriesLaboratory safetyLossesMonitoringOccupational safetyProgram evaluationReporting requirementsRisk managementSafety regulationSafety standardsPolicies and procedures