Program Goals and Organizational Culture Guide Safety Reporting System Design and Implementation in Three Key Areas

According to lessons from our review of the literature, the design and  implementation of an effective safety reporting system (SRS) includes  consideration of program goals and organizational culture for decisions in  three key areas: reporting and analysis, reporter protection and incentives,  and feedback mechanisms. Case Studies Demonstrate the Need for Assessment and Resources in Design and Implementation and Suggest Certain Features in the Three Key Areas

Lessons from case studies of safety reporting systems (SRS) in three  industries—aviation, commercial nuclear power, and health care— indicate the importance of cultural assessment and resource dedication in  SRS design and implementation, and suggest certain features in the three  key areas. 3. Reporting has  increased. Lesson 2: Broad Reporting Thresholds, Experience- Driven Classification Schemes, and Processing at the Local Level Are Useful Features in Industries New to Safety Reporting

After the three industries instituted a voluntary SRS, workers experienced  a sharp learning curve in recognizing a reportable event and developing  trust in reporting. The CDC and APHIS Have Taken Steps to Improve the Usefulness of the TLR Reporting System; Lessons from the Literature and Case Studies Suggest Additional Steps

The CDC and APHIS Select Agent Program (SAP) has taken steps to  improve reporting and enhance the usefulness of the theft, loss, and  release (TLR) reporting system as a safety tool. Expanding the TLR reporting threshold to  include hazards could provide additional data that might be useful for  safety improvement efforts. The CDC and NIH—as recognized authorities on working safely with  infectious diseases—disseminate safety information to the entire lab  community. The Centers for Disease Control and Prevention (CDC) and Animal and  Plant Health Inspection Service (APHIS) Select Agent Program (SAP)  manage a mandatory reporting system for theft, loss, and release (TLR) of  select agents. Both of these  reporting options will also require strong confidentiality protections, data  deidentification, and other reporting incentives to foster trust in reporting. Matters for Congressional Consideration

In developing legislation for a national reporting system for the biological  laboratory community, Congress should consider provisions for the  agency it designates as responsible for the system to take into account the  following in design and implementation:  include stakeholders in setting system goals;    assess labs’ organizational culture to guide design and implementation    make 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;  incorporate strong reporter protections, data deidentification measures,  and other incentives for reporting;    develop feedback mechanisms and an industry-level entity for  disseminating safety data and safety recommendations across the lab  community; and    ensure ongoing monitoring and evaluation of the safety reporting system  and safety culture. Lastly, the HHS partially agreed with the third recommendation. While the  agency agreed with the recommendation to develop processes for  identifying reporting gaps and system evaluation to support targeted  outreach and system modification, they disagreed with the  recommendation to share TLR data for international lab safety  improvement efforts. GAO staff who made major contributions to this report  are listed in appendix V.

Appendix I: Objectives, Scope, and Methods

This appendix details the methods we used to identify lessons for  designing and implementing an effective safety reporting system (SRS)  from (1) the literature and (2) case studies of SRSs in the airline,  commercial nuclear power, and health care industries; and apply those  lessons to (3) assess the theft, loss, and release (TLR) reporting system for  the Select Agent Program and (4) suggest design and implementation  considerations for a national SRS for all biological labs. (1) Assessment, dedicated resources, and  management focus are needed to  understand and improve safety culture. (3) Strong legal protections and incentives  encourage reporting and help prevent  confidentiality breaches. (1) Consider limited immunity provisions to increase the reporting  incentive. (4) A central, industry-level unit facilitates  lesson sharing and evaluation. That is  why our recommendations for improvements to the TLR program are  directed to the CDC and APHIS, while recommendations for a national  SRS for all labs are directed to Congress through matters for  consideration. 3. 2, no. GAO. 1-2.
Why GAO Did This Study

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.

What GAO Found

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.

What GAO Recommends

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.