Documenting and reporting laboratory safety and security breaches
A major conclusion of the research is the need for earlier detection and for more systematic documenting and reporting of these breaches at the national level, to improve the quality of information on which efforts to strengthen safety and security are based. To a large extent, both the amount and the quality of available information remain insufficient, even in well-resourced countries. In many situations, there may be a requirement to record accidents in a laboratory ledger or computer system, but the information is not passed up to the national level, nor is it published or shared with the wider biosafety community seeking to learn lessons from such breaches. It is important to note that reporting of accidents may be included as a requirement in a laboratory’s biosafety and biosecurity strategy: however, that specific part of the strategy may not be adequately funded.
Where laboratory reporting systems are in place, they often need to be improved, and where there are no reporting systems, they should be established. Reporting should include not only the occurrence of breaches but also analysis of the root causes. This would help greatly in achieving a more accurate understanding of the scale of the problem, identifying lessons to be learned and therefore directly informing improvements in laboratory safety and security.
Relevant to root-cause analysis is the role played in avoidable human error by senior decision-makers, for example by failing to listen to concerns from workers about working practices, by not allowing the work to be done properly, or by creating a culture of fear such that workers will not report incidents for fear of reprisals.
Thought needs to be given to a range of issues related to reporting, such as: raising awareness of how reporting can improve risk management and lead to safer and more secure laboratories; considering how best to provide incentives to encourage the behaviour changes that are needed; deciding what should constitute an incident that requires reporting; and determining what type of reporting system is appropriate and achievable. The latter should include consideration of whether efforts should be made to establish a global norm and whether enforcement or verification mechanisms are needed – or, where they are already in existence, whether they are functioning properly. Consideration also needs to be given to how best to support the development and implementation of robust reporting systems at a national level.
Globally, it has to be recognized that reporting requirements – such as those that exist for outbreaks of infectious diseases of international concern under the International Health Regulations and for animal diseases and zoonoses under WOAH international standards – can constitute a sensitive political issue and thus a further challenge for policymakers to consider. There can be concerns over geopolitical implications, further intrusive scrutiny, embarrassment and reputational damage, at both the laboratory management level and at the political level. For instance, no country would want to be included in a list of disease emergence ‘hotspots’ linked to laboratory biocontainment breaches.
To inform decision-making, it is important to understand the extent and circumstances not only of accidents, but also of near misses.
A shift towards a risk-based approach
To minimize the likelihood and consequence of pathogen leaks, the research emphasizes the importance of continuing towards the adoption of an integrated and sustainable risk-based approach. This approach must consider the pathogens, the type of activity and the personnel performing it, as well as the local context, including the resources context, and stands in contrast to the more traditional approach, which applies a one-size-fits-all classification of laboratories based solely on the hazard category of the organisms they handle. Risk analysis – particularly risk assessment and risk management, including decision-making as to which risk management option to choose – needs to be informed by an evidence base. This, in turn, should be informed by reporting, by lessons learned from laboratory accidents and near misses, and by ongoing systematic review of the available evidence.
Such a shift would mark an important evolution in the understanding of biosafety. A wide range of laboratories – including government diagnostic and research laboratories, and other public, academic or private laboratories – with different biosafety level classifications work with high-consequence pathogens. Many different activities take place in laboratories within the same biosafety classification. For instance, Biosafety Level 3-classified laboratories include considerable numbers of clinical diagnostic laboratories around the world, as well as large research laboratories conducting potentially high-consequence experiments with wild animals. Routine diagnostic activities in a small hospital laboratory would likely have a very different risk profile from the activities of a large research laboratory that might be developing medical countermeasures or investigating novel animal or human pathogens.
It is also important to consider the environment outside the laboratory itself. For example, if a pathogen is widely detected in nature – as in the case of the anthrax bacillus, which is found in infected animal carcasses – in any one country, the biosafety and biosecurity measures adopted might reasonably be different from those employed in a country where anthrax is rarely seen. Laboratory biocontainment policies therefore need to be consistent with the relevant national infectious disease control policies.
The risk-based approach is relevant to all aspects of the laboratory system, including not only research and waste disposal, but also facility and engineering controls and administrative controls.
The global biosafety community – in the human, animal and environmental health sectors – is moving in this direction, and it is a key part of making laboratories across the world more sustainable. But progress has been slow to date. If laboratories are not sustainable, lapses in laboratory biosafety and biosecurity, giving rise to laboratory infections and leaks, will be more likely.
If laboratories are not sustainable, lapses in laboratory biosafety and biosecurity, giving rise to laboratory infections and leaks, will be more likely.
Increases in regulation are not necessarily indicated, particularly where tighter regulation is likely to remain unenforced or, worse, fails to address the core problems. Agencies such as WOAH and WHO have issued updated best-practice guidance on biosafety, including on minimizing the likelihood and consequences of laboratory accidents. However, regulations remain in place which do not allow for a risk-based approach, and many practices that are currently being followed either do not have an evidence base or are disproportionate or otherwise inappropriate to the risk involved in the procedures. Furthermore, what works in one region may not be appropriate in another. For instance, an outbreak of foot and mouth disease in the United States or the United Kingdom would require a more aggressive approach to biocontainment (in laboratories) and biosecurity (on farms) to stop it becoming widespread, with severe consequences for national and international trade, in comparison with a similar-sized outbreak (in terms of the number of cases) in a country where the disease is already endemic.
These examples illustrate that much more can – and must – be done to move away from traditional thinking around one-size-fits-all global biosafety and biosecurity standards, and to build the risk-based approach into laboratory culture around
the world.
Training and education
The biosafety profession is still very much in its infancy in many parts of the world, and there is a severe shortage of personnel with the skills to make risk-based assessments or develop a risk-based approach. Therefore, although WOAH, WHO and other organizations have issued guidance, there are currently too few competent professionals to make the laboratory system resilient and sustainable. The gap in risk analysis capacity needs to be addressed. A lack of standardization of professional qualifications across the biosafety industry further complicates the issue.
Meanwhile, many countries face capacity and capability shortfalls more widely, making the fundamental biosafety and biosecurity challenges difficult or impossible to manage. These shortfalls need to be addressed without delay. Successfully making the shift to a risk-based approach entails strengthening training and education, not only on how to adopt and implement the approach, but also to build capacity and capability for robust risk assessment and ethics review. In addition, each laboratory should have its own guidance and on-the-job training programme for its staff, supplemented by enhanced specialized training for staff who undertake particular functions. Some international funders are starting to devote resources to filling that gap, but there is a long way to go. The ability to manage laboratory biosafety and wider biosecurity will remain compromised as long as these gaps remain unaddressed.
Furthermore, the necessary shift in mindset needs to be introduced earlier in career development terms, particularly through the higher education system. This, together with a greater awareness of emerging technologies – some of which will make, or have already made, laboratory work safer and some of which will present new risks – will undoubtedly help progress to be made in the future.
The wider context of laboratory activity
In addition to what happens in laboratories, there is a wider chain of activity in pathogen research that is important for biosafety and biosecurity and that remains largely ungoverned, at both the national and international levels.
A conversation is also urgently required on the value of establishing an oversight mechanism for high-consequence research involving dangerous pathogens and activities along the entire chain of activities, from risky practices in wildlife sample collection in the field and the transport of specimens, to laboratory-based activities, to biobanking of samples and waste disposal.