Biosafety Practices Research Articles

Laboratory Focus on Improving the Culture of Biosafety: Statewide Risk Assessment of Clinical Laboratories That Process Specimens for Microbiologic Analysis.

The Wisconsin State Laboratory of Hygiene challenged Wisconsin laboratories to examine their biosafety practices and improve their culture of biosafety. One hundred three clinical and public health laboratories completed a questionnaire-based, microbiology-focused biosafety risk assessment. Greater than 96% of the respondents performed activities related to specimen processing, direct microscopic examination, and rapid nonmolecular testing, while approximately 60% performed culture interpretation. Although they are important to the assessment of risk, data specific to patient occupation, symptoms, and travel history were often unavailable to the laboratory and, therefore, less contributory to a microbiology-focused biosafety risk assessment than information on the specimen source and test requisition. Over 88% of the respondents complied with more than three-quarters of the mitigation control measures listed in the survey. Facility assessment revealed that subsets of laboratories that claim biosafety level 1, 2, or 3 status did not possess all of the biosafety elements considered minimally standard for their respective classifications. Many laboratories reported being able to quickly correct the minor deficiencies identified. Task assessment identified deficiencies that trended higher within the general (not microbiology-specific) laboratory for core activities, such as packaging and shipping, direct microscopic examination, and culture modalities solely involving screens for organism growth. For traditional microbiology departments, opportunities for improvement in the cultivation and management of highly infectious agents, such as acid-fast bacilli and systemic fungi, were revealed. These results derived from a survey of a large cohort of small- and large-scale laboratories suggest the necessity for continued microbiology-based understanding of biosafety practices, vigilance toward biosafety, and enforcement of biosafety practices throughout the laboratory setting.

Promoting Scientific Transparency to Facilitate the Safe and Open International Exchange of Biological Materials and Electronic Data.

Scientific communication, collaboration and progress are enhanced through the exchange of data, materials and ideas. Recent advances in technology, commercial proprietary discovery and current local and global events (e.g., emerging human, animal and plant disease outbreaks) have increased the demand, and shortened optimal timelines for material and data exchange, both domestically and internationally. Specific circumstances in each case, such as the type of material being transferred (i.e., select agent, disease-causing agent and assessed biosafety risk level) and current events, dictate the level of agreements and requirements. Recent lessons learned from emerging disease issues and emergencies have demonstrated that human engagement and increased science diplomacy are needed to reinforce and sustain biosafety and biosecurity practices and processes, for better scientific transparency. A reasonable and accepted framework of guidance for open sharing of data and materials is needed that can be applied on multiple cooperative levels, including global and national. Although numerous agreement variations already exist for the exchange of materials and data, regulations to guide the development of both the language and implementation of such agreements are limited. Without such regulations, scientific exchange is often restricted, limiting opportunities for international capacity building, collaboration and cooperation. In this article, we present and discuss several international case histories that illustrate the complex nature of scientific exchange. Recommendations are made for a dual bottom-up and top-down approach that includes all stakeholders from beginning negotiation stages to emphasize trust and cooperation. The broader aim of this approach is to increase international scientific transparency and trust in a safe and open manner, supporting increased global one health security.

Network Experiences from a Cross-Sector Biosafety Level-3 Laboratory Collaboration: A Swedish Forum for Biopreparedness Diagnostics.

The Swedish Forum for Biopreparedness Diagnostics (FBD) is a network that fosters collaboration among the 4 agencies with responsibility for the laboratory diagnostics of high-consequence pathogens, covering animal health and feed safety, food safety, public health and biodefense, and security. The aim of the network is to strengthen capabilities and capacities for diagnostics at the national biosafety level-3 (BSL-3) laboratories to improve Sweden's biopreparedness, in line with recommendations from the EU and WHO. Since forming in 2007, the FBD network has contributed to the harmonization of diagnostic methods, equipment, quality assurance protocols, and biosafety practices among the national BSL-3 laboratories. Lessons learned from the network include: (1) conducting joint projects with activities such as method development and validation, ring trials, exercises, and audits has helped to build trust and improve communication among participating agencies; (2) rotating the presidency of the network steering committee has fostered trust and commitment from all agencies involved; and (3) planning for the implementation of project outcomes is important to maintain gained competencies in the agencies over time. Contacts have now been established with national agencies of the other Nordic countries, with an aim to expanding the collaboration, broadening the network, finding synergies in new areas, strengthening the ability to share resources, and consolidating long-term financing in the context of harmonized European biopreparedness.

Reform on Knowledge and Skills of Clinical Laboratory Biosafety and Biosecurity Among Chinese Medical Students

Laboratory workers deal with clinical specimens, the threat of exposure to occupational hazards, emerging infectious agents, and antimicrobial-resistant microbes. During student training, it is necessary to strengthen their knowledge and skills in the laboratory. Education covers a range of biosafety and biosecurity principles and practices. 642 medical students from different medicine professions were classified into two groups as research objects and controls to explore the teaching reform of laboratory biosafety, biosecurity theory and experimental courses. Teacher designed programe-based learning (PBL) covered microbiology laboratory biosafety incidents, laboratory training, and the methods used in man-machine interactions in clinical practice. From a four stage reform of laboratory biosafety theory and experimental teaching, the protective awareness of biosafety of the students was strengthened. Students could also run standardized, timely detection protocols and treat laboratory biological factors arising from emergencies and accidents in clinical practice. These increased the competency and proficiency among BSL laboratory users and guarantee adherence to stipulations on biosafety and biosecurity.

Biosafety and Biosecurity in European Containment Level 3 Laboratories: Focus on French Recent Progress and Essential Requirements.

Even if European Union (EU) Member States are obliged to implement EU Directives 2000/54/EC on the protection of workers from risks related to exposure to biological agents at work, national biosafety regulations and practices varied from country to country. In fact, EU legislation on biological agents and genetically modified microorganisms is often not specific enough to ensure harmonization leading to difficulties in implementation for most laboratories. In the same way, biosecurity is a relatively new concept and a few EU Member States are known to have introduced national laboratory biosecurity legislation. In France, recent regulations have reinforced biosafety/biosecurity in containment level 3 (CL-3) laboratories but they concern a specific list of pathogens with no correlation in other European Members States. The objective of this review was to summarize European biosafety/biosecurity measures concerning CL-3 facilities focusing on French specificities. Essential requirements needed to preserve efficient biosafety measures when manipulating risk group 3 biological agents are highlighted. In addition, International, European and French standards related to containment laboratory planning, operation or biosafety equipment are described to clarify optimal biosafety and biosecurity requirements.

¿Cómo influyen los conocimientos de bioseguridad en las prácticas que realizan los enfermeros limeños?

El objetivo fue analizar la fuerza de asociación entre los niveles del conocimiento y prácticas de bioseguridad en los licenciados de enfermería. La muestra fue de 185 licenciados de enfermería de dos hospitales nacionales de Lima. Las variables del estudio fueron: conocimientos y prácticas sobre la bioseguridad. Se empleó la bondad de ajuste de la prueba Hosmer-Lemeshow. De los 185 enfermeros un 50.4% tenía un conocimiento regular de bioseguridad y un 70.8% de los mismos realizaban una práctica apropiada de bioseguridad. Se observa una mayor fuerza de asociación entre el conocimiento bueno y la práctica apropiada de bioseguridad de los enfermeros en comparación con los que tienen un conocimiento regular (OR:2.44). Respecto al conocimiento bueno de la dimensión de medidas de bioseguridad se asoció con una práctica apropiada de bioseguridad (OR:4.38). El conocimiento bueno de bioseguridad influye en la práctica apropiada de la misma en comparación con un conocimiento regular. Se promueve la elaboración de guías de procedimientos acerca de las medidas de bioseguridad según las características del área laboral. Asimismo se recomienda incentivar en los establecimientos de salud el uso de materiales de protección con el fin de aplicar las medidas de bioseguridad de manera eficaz.

Occupational accidents with biological material among professionals in clinical laboratories in Cajazeiras, Paraíba, Brazil.

Occupational accidents in health institutes can result in the transmission of human infectious diseases. Thecollection and processing of biological samples are risk factors for accidents involving clinical laboratory workers. Toidentify occupational accidents with biological material among healthcare workers in the clinical laboratories of Cajazeiras city, Paraíba, Brazil. We conducted a cross-sectional and analytical study using a semi-structured questionnaire distributed to 38 workers at six clinical laboratories. Social-demographic data, types of occupational accidents, post-exposure procedures, biosafety practices, and emotional impact were analyzed. Workplace accidents were reported by 22 (57.9%) interviewees. Female gender (81.6%) was more prevalent in this study population. Nurse technicians and biochemists related the most frequent exposures. Accidents occurred mainly in the upper extremities (91%). The biological fluids related to the occupational accidents included blood (81.8%) and urine (45.5%). Thirty-three (86.8%) workers reported undergoing a post-exposure evaluation in the workplace. Fourteen (63.6%) participants underwent laboratory testing after biological material exposure. The data showed that occupational accidents in clinical laboratories are frequent among healthcare workers. We suggest new approaches for occupational accidents in the clinical laboratories to ameliorate the biosafety guidelines and working conditions of healthcare professionals.

Development of an RT-qPCR assay for the specific detection of a distinct genetic lineage of the infectious bursal disease virus

ABSTRACTThe infectious bursal disease virus (IBDV) is a major health threat to the world’s poultry industry despite intensive controls including proper biosafety practices and vaccination. IBDV (Avibirnavirus, Birnaviridae) is a non-enveloped virus with a bisegmented double-stranded RNA genome. The virus is traditionally classified into classic, variant and very virulent strains, each with different epidemiological relevance and clinical implications. Recently, a novel worldwide spread genetic lineage was described and denoted as distinct (d) IBDV. Here, we report the development and validation of a reverse transcription-quantitative polymerase chain reaction (RT-qPCR) assay for the specific detection of dIBDVs in the global poultry industry. The assay employs a TaqMan-MGB probe that hybridizes with a unique molecular signature of dIBDV. The assay successfully detected all the assessed strains belonging to the dIBDV genetic lineage, showing high specificity and absence of cross-reactivity with non-dIBDVs, IBDV-negative samples and other common avian viruses. Using serial dilutions of in vitro-transcribed RNA we obtained acceptable PCR efficiencies and determination coefficients, and relatively small intra- and inter-assay variability. The assay demonstrated a wide dynamic range between 103 and 108 RNA copies/reaction. This rapid, specific and quantitative assay is expected to improve IBDV surveillance and control worldwide and to increase our understanding of the molecular epidemiology of this economically detrimental poultry pathogen.

BSL2 Audit and Certification Program: An Effort to Harmonize and to Raise Standards in Both Laboratory Infrastructure and Biosafety Practices in Singapore

The critical aspects of biosafety and bio-containment have been increasingly important in recent years. Biological agents involved in biological research projects at the Nanyang Technological University (NTU) Singapore are usually those with low risks. Biosafety level 2 or BSL 2 laboratories are widely used. However, biosafety measures which refer to the implementation of laboratory practices and procedures, specific construction features of laboratory facilities and safety equipment must be in place to reduce the exposure of laboratory personnel, the public or the environment to potentially infectious agents or other biological hazards. It is also required to pay more attention to laboratory-acquired infections (LAIs) which may occur in research laboratories, clinical laboratories or animal facilities. BSL 2 audit and certification program is implemented as an internal exercise covering laboratories in the university where biological agents are handled or biological research works are carried out. We have put some efforts to raise biosafety standards university-wide in both laboratory infrastructure and laboratory practices to a higher level. Common audit findings are briefly discussed in this presentation.

Status of Laboratory Biosafety and Biosecurity in Veterinary Research Facilities in Nigeria.

BackgroundThis study determined current status of laboratory biosafety in Nigerian veterinary research facilities.MethodsA questionnaire was developed to obtain information from researchers across Nigeria from July 2014 to July 2015. Information regarding demographics, knowledge of laboratory biosafety, availability and proper use of personal protective equipment (PPE), any priority pathogens researched, attitude on and use of standard laboratory practices, and biosafety awareness was obtained using a numeric scoring system. Data were analyzed with descriptive statistics, and univariate and multivariate logistic regression.ResultsA total of 74 participants from 19 facilities completed the questionnaire. General knowledge scores ranged from 3 to 28 (out of 28 possible points), with 94.6% of respondents receiving low scores (scores < mean + 1 standard deviation). Very few (17.6%) reported availability or use PPE. Many participants (63.5%) reported no access to biosafety level (BSL)-1–3 facilities. None reported availability of a BSL-4 facility. Knowledge scores pertaining to biosafety management practices ranged from 0 to 14 (out of 14 possible points) with 47.3% of respondents receiving good scores (scores > mean + 1 standard deviation). Only 16.2% of respondents (from four facilities) reported having biosafety officers. Rabies virus was the most researched pathogen (31.1% of respondents). The majority (71.6%) were unaware of laws guiding biosafety. Researchers [odds ratio (OR) = 18.0; 95% confidence interval (CI): 1.63, 198.5; p = 0.023], especially in BSL-2 (OR = 258.5; 95% CI: 12.71, 5256; p < 0.001) facility of research institute (OR = 25.0; 95% CI: 5.18, 120.6; p < 0.001), are more likely to have adequate access to and properly utilize biosafety devices and PPE.ConclusionsCurrent knowledge of laboratory biosafety is limited except among a few researchers.

Barriers to Implementation of Optimal Laboratory Biosafety Practices in Pakistan.

The primary goal of biosafety education is to ensure safe practices among workers in biomedical laboratories. Despite several educational workshops by the Pakistan Biological Safety Association (PBSA), compliance with safe practices among laboratory workers remains low. To determine barriers to implementation of recommended biosafety practices among biomedical laboratory workers in Pakistan, we conducted a questionnaire-based survey of participants attending 2 workshops focusing on biosafety practices in Karachi and Lahore in February 2015. Questionnaires were developed by modifying the BARRIERS scale in which respondents are required to rate barriers on a 1-4 scale. Nineteen of the original 29 barriers were included and subcategorized into 4 groups: awareness, material quality, presentation, and workplace barriers. Workshops were attended by 64 participants. Among barriers that were rated as moderate to great barriers by at least 50% of respondents were: lack of time to read biosafety guidelines (workplace subscale), lack of staff authorization to change/improve practice (workplace subscale), no career or self-improvement advantages to the staff for implementing optimal practices (workplace subscale), and unclear practice implications (presentation subscale). A lack of recognition for employees' rights and benefits in the workplace was found to be a predominant reason for a lack of compliance. Based on perceived barriers, substantial improvement in work environment, worker facilitation, and enabling are needed for achieving improved or optimal biosafety practices in Pakistan.

Recent Scenario of Emergence of Kyasanur Forest Disease in India and Public Health Importance

Several viral hemorrhagic fever (VHF) diseases affect large populations in India. Among these, Dengue is the most common endemic mosquito-borne VHF disease. Two other common VHF diseases are tick-borne: Kyasanur Forest disease (KFD) and Crimean Congo hemorrhagic fever (CCHF). CCHF was detected in India recently. KFD virus has a wide range of tick vector species and involves several mammalian hosts. Until 2011, KFD was seen only in southern India, but recently its presence was confirmed in the Western Ghats region, including Karnataka, Tamil Nadu, Kerala, Goa and Maharashtra states. This discovery has raised suspicion whether it existed earlier in these areas. Although, the risk of human-to-human transmission of this disease is very low, it is important to consider the high prevalence of the vectors namely ticks; small mammals, monkeys, and domestic animals that are carriers of infected ticks as well as deforestation. Knowledge of KFD pathogenicity, improved and cost-effective diagnostics, laboratory networks, increased awareness of travelers to forested areas, and surveillance are needed to reduce fatality. The use of standard biosafety practices in handling the virus in the laboratory and in associated field work reduces the risk associated with infection.

A Case-Study of Implementation of Improved Strategies for Prevention of Laboratory-acquired Brucellosis.

BackgroundIn 2012, the Alaska Section of Epidemiology investigated personnel potentially exposed to a Brucella suis isolate as it transited through three laboratories.MethodsWe summarize the first implementation of the United States Centers for Disease Control and Prevention 2013 revised recommendations for monitoring such exposures: (1) risk classification; (2) antimicrobial postexposure prophylaxis; (3) serologic monitoring; and (4) symptom surveillance.ResultsOver 30 people were assessed for exposure and subsequently monitored for development of illness. No cases of laboratory-associated brucellosis occurred. Changes were made to gaps in laboratory biosafety practices that had been identified in the investigation.ConclusionAchieving full compliance for the precise schedule of serologic monitoring was challenging and resource intensive for the laboratory performing testing. More refined exposure assessments could inform decision making for follow-up to maximize likelihood of detecting persons at risk while not overtaxing resources.

Wildlife veterinarians rabies vaccination in Chile: a survey

Rabies is a lethal but preventable disease. Knowing the extent of immunization coverage among at risk populations, may help to guide immunization efforts, as well as increase the effectiveness of rabies control and prevention programs. To determine the proportion of wildlife veterinarians in Chile, as part of a group at risk of rabies transmission. An electronic survey was sent to wildlife veterinarians in Chile. We found that veterinarians in Chile work mainly with carnivores and deer compared to other mammals (p < 0.001), rarely works with bats (p = 0.6572). Most of the participants had been bitten by domestic animals, while a lesser proportion (29%) by wild animals. Most of the participants never received rabies vaccination (53%), while within the group that had started a rabies vaccination scheme, a substantial proportion (39%) did not complete it. Identify the vaccination status of risk groups is important for infectious disease control and prevention programs, as this information helps to identify priority groups during outbreaks or vaccine scarcity. Wildlife veterinarians in Chile are at risk of rabies transmission and should be included in rabies prevention programs, especially considering their vulnerability and lack of biosafety practices. Increasing education in rabies epidemiology and prevention is urgently needed in veterinary faculties in Chile.

Effects of a plasma heating procedure for inactivating Ebola virus on common chemical pathology tests.

The recent declaration of Ebola virus disease as epidemic by the World Health Organization indicates urgency for affected countries and their laboratories to evaluate and provide treatment to patients potentially infected by the Ebola virus. A heat inactivation procedure involving treating specimens at 60°C for 60 minutes has been suggested for inactivation of the Ebola virus. This study aimed at evaluating the effect of plasma heating on common biochemical tests. Comparative experimental study. A regional chemical pathology laboratory in Hong Kong. Forty consecutive plasma specimens for general chemistry analytes on Beckman Coulter AU5822 and another 40 plasma specimens for troponin I analysis on Access 2 Immunoassay System were obtained, anonymised, and divided into two aliquots. One aliquot was analysed directly and the other was analysed after heating at 60°C for 60 minutes. A total of 20 chemical pathology tests were evaluated. Nine tests (sodium, potassium, chloride, urea, creatinine, total calcium, phosphate, total protein, and glucose) were not significantly affected by the heat inactivation procedure and remained clinically interpretable. Results for magnesium (15% mean increase), albumin (41% mean increase), bilirubin (8% mean decrease), amylase (27% mean decrease), and troponin I (76% mean decrease) were still interpretable using regression estimation with proportional bias. However, all enzymes studied except amylase (alanine transaminase, aspartate transaminase, alkaline phosphatase, gamma-glutamyltransferase, creatine kinase, and lactate dehydrogenase) were inactivated to a significant degree. Their Pearson r or Spearman rho values ranged from no significant correlation (P≥0.05) to 0.767, and most normality was rejected. Heat inactivation results in no significant change in electrolytes, glucose, and renal function tests, but causes a significant bias for many analytes. Recognition of the relationship between pre- and post-heat inactivation specimens allows clinical interpretation of affected values and contributes to patient care. For safety and diagnostic accuracy, we recommend use of a point-of-care device for blood gases, electrolytes, troponin, and liver and renal function tests within a class 2 or above biosafety cabinet with level 3 or above biosafety laboratory practice.

A Survey of Biosafety Practices of Clinical Laboratory Personnel in Four Selected Clinical Laboratories

Objective: Biosafety is an important element of quality management systems in laboratory practice as it is a measuring tool for compliance with accreditation and certification standards. Our aim was to assess the practices of laboratory personnel towards biosafety measures in their respective laboratories. Methods: The study design was a quantitative and qualitative cross sectional prospective one obtained with the use of a structured questionnaire. Data analysis was done with Epi Info version 3.4.1 and was presented using frequency tables with chi square calculated for different variables with the significant p value set at ≤ 0.05. Results: There were 63 respondents in the study. Private laboratories fared better in an assessment of their biosafety practices. Comparative variables identified as unsafe biosafety practices between public and private laboratories were non availability of Hepatitis B virus antibody testing, p value 0.01, odds ratio 5.4, consuming food in the laboratory, p value 0.00, odds ratio 0.2., non-use of N95 masks p value 0.04, O.R 3.9 and biosafety cabinet use p value 0.05, O.R 2.8. Discussion: Biosafety practices in Nigeria need to be streamlined in accordance with good laboratory practices in order to forestall workplace accidents and promote a safe environment for testing of clinical human samples. Conclusion: The absence of appropriate biosafety policies and practices is one of the challenges facing health care workers in sub Saharan Africa. There is the need for biosafety to be placed in the front burner of issues in laboratory practice in our respective facilities.

Biosafety principles and practices for the veterinary diagnostic laboratory.

Good biosafety and biocontainment programs and practices are critical components of the successful operation of any veterinary diagnostic laboratory. In this chapter we provide information and guidance on critical biosafety management program elements, facility requirements, protective equipment, and procedures necessary to ensure that the laboratory worker and the environment are adequately protected in the challenging work environment of the veterinary diagnostic laboratory in general and provide specific guidance for those laboratories employing molecular diagnostic techniques.

Knowledge and practices of laboratory workers on standardized antimicrobial susceptibility testing and biosafety practices to prevent the spread of superbugs in Pakistan

A cross-sectional survey using structured questionnaire was conducted to assess practices of microbiological laboratories working with pathogens. Forty-eight laboratory workers (50%) agreed that laboratory methods to detect antimicrobial resistance are not standardized in Pakistan, and 6% of the laboratory workers were not aware of the standardization of antimicrobial susceptibility testing in Pakistan. Reported rates of awareness regarding the role of waste disposal, disinfection, and handwashing in limiting the spread of antimicrobial resistance were 75%, 42%, and 81%, respectively. Our results provide baseline data for planning programs to train, supervise, and improve the operational quality of microbiological laboratories nationwide to prevent the spread of superbugs.

National-level biosafety norms needed for dual-use research.

National-level biosafety norms needed for dual-use research.

Biosafety in the Field: An Account of a Kyrgyz Antiplague Expedition

The Soviet Union had a unique system to control plague (causative agent, Yersinia pestis) and other “especially dangerous diseases.” This system continues to exist in many of the countries of the former Soviet Union, although with more limited funding. One of the key activities of the antiplague system is to look for the causative agent of plague in its natural reservoirs in the environment. This article is an account of an antiplague expedition that took place in the mountains of eastern Kyrgyzstan near the Chinese border. It describes the work conducted and the biosafety and biosecurity practices employed. During the 40-day expedition: A field laboratory was established; known Y. pestis reservoirs such as gray marmots were trapped and analyzed for plague using serological, bacteriological, and biological methods; information on the populations of rodents and their ectoparasites was gathered; and gray marmot burrows were treated with insecticide intended to kill the fleas and so control plague. An area of 800 km2 was investigated, and a total of 321 rodents analyzed. Y. pestis was found in the region for the first time since 1983. The laboratory and biosafety practices employed were determined by Kyrgyz government regulations, which are largely based on Soviet regulations and practices. Some of these practices might be considered dated in the West. However, the apparent lack of infections acquired as a result of this work, over a period of many years, would suggest that the safety procedures are effective.