Developing Norms for the Provision of Biological Laboratories in Low-Resource Contexts Proceedings of a Workshop (2019) / Chapter Skim
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2 THE NEED FOR CONTAINMENT LABORATORIES
2 THE NEED FOR CONTAINMENT LABORATORIES
Pages 7-16
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From page 7... ...
and other infectious agents in research and medicine; making accurate and rapid diagnoses for PPPs and other infectious agents to ensure appropriate medical care; detecting antimicrobial resistance in infectious agents; facilitating epidemiological investigations of infectious disease outbreaks; and detecting biological attack agents. During his presentation on the need for containment laboratories, Tom Ksiazek, DMV, used the above list as a guide, reframing the needs as follows: Diagnostics -- identifying etiology Supporting clinical care -- identifying cases Supporting epidemiology identifying cases identifying chains of transmission using modern molecular tools Supporting and carrying out ecological investigations Applied research Testing and evaluating therapeutics -- preclinical studies Testing and evaluating vaccines Basic research -- developing pathways and targets for therapeutics and vaccines Dr.
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From page 8... ...
But there remains a need to provide public health services and medical treatment, such as diagnostics and epidemiological work, in low-resource settings. This fact creates a dilemma for policy makers who must balance the need to improve public health with the need to prevent the use of hazardous pathogens as weapons of mass destruction.
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From page 9... ...
However, because an Army laboratory inadvertently sent live samples rather than inactivated samples of Bacillus anthracis (anthrax) to scores of other laboratories, the company announced in July 2015 that it will no longer ship research samples of Select Agents through its regular shipping service.
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FIGURE 2.1 Personal protection plotted against environmental containment, showing the distribution of the containment levels along these two metrics. SOURCE: Thomas Ksiazek.
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To detect biological attack agents and to distinguish engineered agents from naturally occurring outbreaks, researchers need epidemiological information to sort outbreak situations and early sequence data to assess what species or strain the attack agent is most closely related to. Depending on the nature of the agents, such situations may require either tier 1 or regional reference labs or both.
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FIGURE 2.2 Surveillance leading to early detection and outbreak responses, which in turn led to a significant decrease in intensity and duration of VHF outbreaks in Uganda. SOURCE: Shoemaker et al., 2018.
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From page 13... ...
Kojima noted that the LBM revision is meant to follow an "evidence-based" and "risk-based" approach, as the best way to inform the risk assessment process and policy instruments, allow logical prioritization to avoid overkill and overdesign of lab facilities, and learn from actual incidents to prevent recurrences. These considerations should facilitate resource optimization.1 He also discussed the findings from "Surveillance of laboratory exposures to human pathogens and toxins: Canada 2016."2 In 2016, a total of 100 lab workers were accidentally exposed with no reports of secondary exposures.
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From page 14... ...
The Canadian data on laboratory accidents showed that the most well-designed and engineered laboratory is only as good as its least-trained worker, and that human factors are generally the cause of laboratory-acquired infections rather than malfunction of engineering controls. However, "risk (hazard)
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From page 15... ...
The revised WHO LBM will replace risk groups and biosafety levels with a thorough risk assessment and appropriate risk mitigation and control measures based on the consequence of infection from the pathogen and the risks associated with the procedures to be performed. Activities that have only "core requirements," the minimum requirements for safely executing the majority of lab procedures, because there is a low process risk and low consequence of infection.
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From page 16... ...
WHO will undertake a new project to analyze the biosafety and biosecurity legislative framework of different WHO Member States and to develop a proposal for a harmonized international approach to ensure state-of-the art legislation for biosafety and biosecurity in biomedical laboratories.
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