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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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.

According to the literature, effective design and implementation of a safety reporting system (SRS) includes consideration of program goals and organizational culture to guide decisions in three key areas: (1) reporting and analysis, (2) reporter protection and incentives, and (3) feedback mechanisms. Program goals are best identified through stakeholder involvement and organizational culture, through assessment. Case studies of SRSs in three industries--aviation, commercial nuclear, and health care--indicate that (1) assessment, dedicated resources, and management focus are needed to understand and improve safety culture; (2) broad reporting thresholds, experience-driven classification schemes, and local-level processing are useful SRS features in industries new to safety reporting; (3) strong legal protections and incentives encourage reporting and prevent potential confidentiality breaches; and (4) a central, industry-level unit facilitates lesson sharing and evaluation. While the CDC and APHIS Select Agent Program (SAP) has taken steps in the three key areas to improve the usefulness of the TLR system for select agents, steps for improvement remain. Specifically, the agencies have taken steps to better define reportable events, ensure the confidentiality of reports, and dedicate resources to use TLR data for safety improvement. However, lessons from the literature and case studies suggest additional steps in the three key areas to enhance the usefulness of the system. For example, lowering reporting thresholds could provide precursor data and limited immunity could increase the incentive to report. Finally, the CDC and APHIS are in a unique position--as recognized authorities in the lab community and with access to TLR reports from across the industry--to guide SRS evaluation and ensure safety lessons are broadly disseminated. For a national safety reporting system for all biological labs, existing information--about labs' organizational culture and the lab community's limited experience with SRSs--suggests the following features in the three key areas: (1) Reporting and analysis. Reporting should be voluntary; available to all workers; cover hazards, incidents, and less serious accidents; accessible in various modes (Web and postal); and with formats that allow workers to report events in their own words to either an internal or external SRS system. (2) Reporter protections and incentives. Strong confidentiality protections, data deidentification processes, and other reporting incentives are needed to foster trust in reporting. (3) Feedback mechanisms. SRS data should be used at both the local and industry levels for safety improvement. An industry-level entity is needed to disseminate SRS data and to support evaluation. GAO recommends that, in developing legislation for a national SRS for biological labs, Congress consider provisions for certain system features. GAO also recommends three improvements to the CDC and APHIS TLR system. HHS disagreed with the first two recommendations and partially agreed with the third. USDA agreed with the three recommendations.

Matter for Congressional Consideration

  1. Status: Open

    Comments: Congress has not taken action on this recommendation.

    Matter: 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.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: 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.

    Recommendation: 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.

    Agency Affected: Department of Agriculture: Animal and Plant Health Inspection Service

  2. Status: Closed - Implemented

    Comments: 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.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services: Public Health Service: Centers for Disease Control

  3. Status: Closed - Implemented

    Comments: Regarding executive recommendation (3) only: 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.

    Recommendation: 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.

    Agency Affected: Congress

 

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