Development and implementation of evidence-based laboratory safety management tools for a public health laboratory
Graphical abstract
Introduction
Laboratory safety is first, and most importantly, an occupational health concern for the estimated 290,988 public health workers in the United States (Beck et al., 2014). However, contaminated or infected employees can also transmit occupationally acquired pathogens outside the laboratory, making any actual or perceived safety breach in a public health laboratory a serious concern (ASTPHLD, 1997, Fleck, 2004, Blaser and Lofgren, 1981, Hawkes, 1979). In 2014, a series of safety incidents among multiple federal agencies drew extensive national media attention to the issue of safety in public health laboratories (McCarthy, 2014). These safety failures can erode trust in the public health system (Cohen, 2014), which has the potential to decrease compliance with public health agency recommendations (Ward, 2017). Therefore, the consequences of laboratory incidents in public health laboratories can be severe and widespread, even when occupational health risks are low (Centers for Disease Control and Prevention, 2014).
While incidents involving biological hazards are often the focus of laboratory-related safety discussions, it is well known that laboratories contain many potential hazards - including chemical, physical, and radiological (World Health Organization, 2004, Chosewood and Wilson, 2009, Occupational Health and Safety Administration, 2011). Unfortunately, current data about laboratory incidents is difficult to obtain as there is not yet a standardized system for reporting of laboratory incidents (Chamberlain et al., 2009, Dirnagl et al., 2016, Blaine, 2012). However, some insight into laboratory incidents can be gained using Bureau of Labor statistics, which show that of the incidence rate (2011–2016) of nonfatal occupational injuries and illnesses involving days away from work in medical and diagnostic labs is 100/10,000 full-time workers. Of these 100 illnesses or injuries, the source of 1% were directly related to chemicals and chemical products. The other 99% of illnesses and injuries came from a variety of potential chemical, physical and biological hazards which underlie the Occupational Injury and Illness Classification System 2.01 source categories of containers, furniture and fixtures (15%), machinery (5%), parts and materials (8%), persons, plants, animals and minerals (26%), structures and surfaces (17%), tools, instruments and equipment (4%), vehicles (10%) and other sources (13%). While it is difficult to relate these reported source categories with the underlying hazards, the breadth of incident sources does make obvious the need for laboratory safety risk assessments to consider all-hazards – not just biological. In addition to hazard types, there is a growing body of knowledge about various contributors to workplace safety (e.g. the effects of mental workload (Charles and Nixon, 2019); the need for leadership training (Gravina et al., 2019); the importance of occupational ergonomics (Fasanya and Shofoluwe, 2019) and the effects of worker personality on safety behavior (Jong-Hyun et al., 2018), which have not been well-studied in the laboratory setting.
While laboratory safety has long been a priority in public health laboratories (Moskowitz, 1948, Cook, 1961, Fuscaldo et al., 1980), multiple gaps remain between published best practices and the actual implementation of these practices in laboratories (Westgard, 2017, Herrmann-Werner et al., 2013, Van Noorden, 2013). There are many regulations, guidelines and standards relevant to the work performed in laboratories, but strategies for implementation of these guidelines are left to individual laboratories to develop (World Health Organization, 2004, Chosewood and Wilson, 2009, Richmond and Nesby-O'Dell, 2002, Ned-Sykes et al., 2015, 7 CFR Part 331, 9 CFR Part 121, and 42 CFR Part 73 - Select Agent Regulations, 2018, International Organization for Standardization, 2017, Miller et al., 2012, 42 CFR 493, 2018, United States Code, 1988, International Organization for Standardization, 2018, International Organization for Standardization, 2003, International Organization for Standardization, 2012, 29 USC, 1910, 2018). Laboratory Quality Management Systems (LQMS) can provide a framework for document and process controls, as well as risk assessment and monitoring procedures to improve laboratory safety (Ahlin and Weiss, 2007, Lord, 1990, Nichols, 2011); however, LQMS in public health laboratories are frequently focused on patient safety and test result accuracy as opposed to occupational health and safety (Allen, 2013, Lippi and Guidi, 2007, Njoroge and Nichols, 2014).
The laboratory managers and staff who develop, document and implement laboratory procedures bring their own beliefs, knowledge, education, training, attitudes and experience to their work, and this can affect how they identify and interpret laboratory hazards (Buxton et al., 2011, Steelman and Alexander, 2016, Senthil et al., 2015). Laboratory risk assessments are complex and differ significantly from laboratory to laboratory making a standardized risk assessment approach difficult. However, obtaining a measure of worker perceptions regarding laboratory safety can improve risk management (Xia et al., 2017, Tziaferi et al., 2011). These are compelling reasons why better integration of safety and quality management in public health laboratories is needed (Sciacovelli et al., 2007).
To determine a standardized process of assessing and mitigating laboratory risk, we chose to develop a standardized, evidence-based continuous quality improvement (CQI) cycle. The cycle starts with the solicitation of expert opinion regarding laboratory hazards through an annual survey. Next is the gap analysis of the survey data to identify potential laboratory hazards and perform risk analysis. Based on the gap analysis, we then design and implement targeted mitigation measures. With the subsequent annual survey, the cyclic process ends when data is compared with the previous year to infer the effectiveness of the mitigation interventions and begins again by identifying new hazards or risks to target. Here we describe the development of the survey tool and risk assessment method and the application of these tools to design and evaluate evidence-based interventions.
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Developed practical tools for use by laboratory staff and safety personnel including:
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Annual all-hazards survey tool designed to gather laboratory safety data.
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Tailored to the highest risk group pathogen handled at least weekly
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Collected information on severity, probability and exposure for biological, chemical, physical and radiological hazards associated with equipment and processes performed in the lab.
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Method for stratifying the risk of microorganisms handled in a BSL-2 laboratory
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Three-Dimensional Risk Assessment Tool designed for analysis of survey data
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Identified laboratory-specific risks for targeted intervention
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Potential underutilization of engineering controls
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Potential underreporting of near-misses
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Potentially low awareness of process hazards
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Measured significant differences in survey responses after interventions
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Staff training increased use of engineering controls
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Increased incident reporting burden may cause lower near-miss reporting
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Hazard awareness was increased through presentation of survey results
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Section snippets
CQI stage one - expert opinion
To start the CQI cycle, data is collected from our laboratory staff regarding their perceptions related to laboratory safety using a survey, which utilizes a non-random sampling methodology that is purposive to assess risk and develop mitigation measures in a specific federal public health laboratory. The anonymous survey is offered to all staff in the laboratory on an annual basis, but its completion is not mandated. Because the sampling is purposive, results from this survey are not
Demographics
To describe the sample population while maintaining respondent anonymity, we collected demographic data in a separate survey presented in Table 2. These demographics were collected in March of 2017 (10 months after the 2016 survey and 2 months prior to the 2017 survey) and therefore the demographics are most representative of the population sampled in 2017. The average respondent (see bolded categories) was a non-supervisory laboratory employee; 25–34 years of age with a Master’s-level degree
Discussion
Designing an effective laboratory safety program requires data to formulate safety interventions that are evidence-based (Cote et al., 2016, Yarahmadi et al., 2016, Smith and Morrato, 2014, Kimman et al., 2008, Birnbaum et al., 2016), but data on laboratory safety are limited in various ways. Limitations of published safety data include only being relevant to a specific pathogen (Leunda et al., 2013, Tyshenko et al., 2011, Rozell, 2015, Wagar, 2016, Li et al., 2012, Pedrosa and Cardoso, 2011,
Acknowledgements
This work was supported by the Centers for Disease Control and Prevention, Office of the Associate Director for Laboratory Science and Safety [Laboratory Safety Science and Innovation (LaSSI) Intramural Research Fund]. We would also like to acknowledge the Laboratory Leadership Service Fellowship program and specifically, Ren Salerno, for providing invaluable training in the area of risk assessment. Lastly, we wish to acknowledge the participation of our laboratory staff in the development of
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