Risks faced by laboratory workers in the AIDS era.

Laboratory workers are at occupational risk of exposure to microrganisms that cause a wide variety of diseases, from inapparent to life-threatening ones. Principal routes of transmission include percutaneous and permucosal inoculation (comprising clinical inapparent cutaneous or mucosal exposure to blood or blood products), inhalation, and ingestion. The appearance of the Acquired Immunodeficiency Syndrome (AIDS) epidemic and the first reports of occupational Human Immunodeficiency Virus (HIV) infections in health care workers resulted in high anxiety among laboratory workers. Indeed, 21% of worldwide documented cases of occupational HIV infection occurred among laboratory workers. Research laboratories pose the highest risk of infection. Safe methods for managing infectious agents ("containment") in the laboratory setting include laboratory practice and technique, safety equipment, and facility design. Infection control in the laboratory setting should take into account adherence to guidelines (biosafety levels), education and training, and the development of safety products designed to reduce the risk of exposure.     

Biodefense research: can secrecy and safety coexist?

Over the next 10 years, the United States will spend 6 billion US dollars to develop countermeasures against biological and chemical weapons. Much of this research on highly virulent pathogens will be done in academic settings around the country. This article explores the challenges in ensuring secrecy to protect national security while accommodating the right of local communities to have access to safety information regarding select agents and laboratory-acquired infections. Secrecy has been defended as being vital for protecting national security. Problems with secrecy can include the misinterpretation of intentions, particularly in laboratories located in nuclear weapons design facilities, and the restricted access to information relevant to public health and safety. While federal select agent legislation requires laboratories to have emergency plans in place with first responders, these plans do not necessarily include public health professionals, who will be responsible for any future public health action, such as quarantine, surveillance, or mass vaccinations, in the unlikely event that a laboratory-acquired infection spreads into a community. Laboratory-acquired infections do occur, even with the best safety mechanisms in place; however, the epidemiology of the incidence and severity of these infections are not known since there is no national surveillance reporting system. Evidence suggests that many of these infections occur in the absence of an actual laboratory accident. The best emergency plans and surveillance systems are only as good as the participation and vigilance of the laboratory workers themselves. Thus, laboratory workers have a responsibility to themselves and others to report all laboratory accidents and spills, regardless how minor. In addition, they should have a lower threshold than normal in seeking medical attention when feeling ill, and their physicians should be aware of what pathogens they work with to reduce the risk of a delay in diagnosis.     

Biological Containment Facility for Studying Infectious Disease

To effectively characterize newly recognized viruses (Marburg, Lassa, etc.) and to study other highly virulent infections for which no effective prophylaxis or therapy exists, special containment facilities must be utilized and conventional techniques modified to minimize risk to laboratory personnel. This paper describes a laboratory suite for such studies, contained within a larger research facility; two separate biological safety cabinet systems, animal rooms support laboratories, change room facilities, shower, air lock, and other safety features are contained in the area. Details of design, construction, airflows, and equipment are described in addition to a discussion of operation, techniques, and modification of laboratory equipment utilized in actual studies.     

Implementation of biosurety systems in a Department of Defense medical research laboratory

New biosurety regulations and guidelines were implemented in 2003 because of increased concern for the safety and security of biological select agents and toxins (BSAT) that may be used as weapons of mass destruction. Biosurety is defined as the combination of security, biosafety, agent accountability, and personnel reliability needed to prevent unauthorized access to select agents of bioterrorism. These new regulations will lead to increased scrutiny of the use of select biological agents in registered research laboratories, but the regulations may have unintended effects on cost, progress, and perceptions in programs previously considered part of the academic research community. We review the history of biosurety, evolving guidelines, implementation of the regulations, and impacts at the lead research laboratory for medical biological defense for the Department of Defense.     

Assessment of occupational hazards and associated risks in fuzzy environment: A case study of a university chemical laboratory

University laboratories involve various occupational hazards during the research and course activities, which might affect health and safety of both researchers and students, including chemical, physical, electrical, mechanical, as well as ergonomic and psychosocial risk factors. There are many aspects open to improvements in Occupational Health and Safety management of laboratories, and it is required to deal with risks, reduce them in an acceptable level, and implement control measures. In this study, a risk assessment approach is proposed for the university laboratory operations. The proposed approach incorporates 5S methodology, failure modes and effects analysis (FMEA), interval type-two fuzzy sets (IT2FSs), analytic hierarchy process (AHP), and the VlseKriterijumska Optimizacija I Kompromisno Resenje (VIKOR). AHP is injected into IT2FSs in the phase of evaluation and weighting of severity (S), occurrence (O), and detectability (D) parameters of FMEA. By applying IT2FVIKOR, it is aimed at prioritizing the emerged hazards in the chemical laboratory of the observed university. The proposed approach reveals the important hazards and suggests control measures for managing them. The study methodologically contributes to risk assessment in the knowledge, while a case study in a chemical laboratory of a newly established university offers an insight into education industry in safety improvement.     

Survey of safety and health care in British medical laboratories.

A retrospective postal survey of 24 000 medical laboratory workers in England, Wales, and Scotland showed highly variable standards of safety and health care. Pre-employment health screening was offered to two-thirds of employees, the physicians being the least likely to be examined (15%). Scottish laboratories provided better safety control than English and Welsh laboratories, while Public Health Service Laboratories had a better record than National Health Service establishments. Mouth pipetting is still practised in 65% of English and Welsh laboratories, and the use of protective clothing is rarely compulsory. The servicing of safety cabinets is often inadequate. Known and suspected carcinogens are still apparently used in a few laboratories (2-10%). In view of the wide variation in standards among laboratories, urgent consideration should be given to establishing regulations for codes of safe practice rather than relying merely on recommendations as at present.     

合成生物学伦理、法律与社会问题探讨

合成生物学是以基因组学、系统生物学知识和分子生物学技术为基础,综合了科学与工程的一门新兴交叉学科。它使生命科学和生物技术研发进入了以人工设计、合成自然界中原本不曾出现的人造生命体系,以及对这些人工体系进行体内、体外优化,或利用这些人造生命体系研究自然生命规律为目标的新时代。然而,合成生物学研究在迅速发展、表现出巨大潜力和应用前景的同时,也引发了社会各界对相关社会、伦理、安全,以及知识产权等问题的重视与讨论。就世界各国针对合成生命对传统意义上生命概念的挑战、合成生物学产品存在的潜在风险危害、合成生物学研究的风险评估与监管等问题进行回顾综述和相关探讨。     

International Society for Analytical Cytology biosafety standard for sorting of unfixed cells.

BACKGROUND: Cell sorting of viable biological specimens has become very prevalent in laboratories involved in basic and clinical research. As these samples can contain infectious agents, precautions to protect instrument operators and the environment from hazards arising from the use of sorters are paramount. To this end the International Society of Analytical Cytology (ISAC) took a lead in establishing biosafety guidelines for sorting of unfixed cells (Schmid et al., Cytometry 1997;28:99-117). During the time period these recommendations have been available, they have become recognized worldwide as the standard practices and safety precautions for laboratories performing viable cell sorting experiments. However, the field of cytometry has progressed since 1997, and the document requires an update. METHODS: Initially, suggestions about the document format and content were discussed among members of the ISAC Biosafety Committee and were incorporated into a draft version that was sent to all committee members for review. Comments were collected, carefully considered, and incorporated as appropriate into a draft document that was posted on the ISAC web site to invite comments from the flow cytometry community at large. The revised document was then submitted to ISAC Council for review. Simultaneously, further comments were sought from newly-appointed ISAC Biosafety committee members. RESULTS: This safety standard for performing viable cell sorting experiments was recently generated. The document contains background information on the biohazard potential of sorting and the hazard classification of infectious agents as well as recommendations on (1) sample handling, (2) operator training and personal protection, (3) laboratory design, (4) cell sorter set-up, maintenance, and decontamination, and (5) testing the instrument for the efficiency of aerosol containment. CONCLUSIONS: This standard constitutes an updated and expanded revision of the 1997 biosafety guideline document. It is intended to provide laboratories involved in cell sorting with safety practices that take into account the enhanced hazard potential of high-speed sorting. Most importantly, it states that droplet-based sorting of infectious or hazardous biological material requires a higher level of containment than the one recommended for the risk group classification of the pathogen. The document also provides information on safety features of novel instrumentation, new options for personal protective equipment, and recently developed methods for testing the efficiency of aerosol containment.     

Exploration and Practice of Biological Engineering Experiment Reform

Reform of experimental teaching should be the integration of relevant experimental courses,rational use of laboratory equipment to share resources and improve equipment utilization.Experimental results showed that the teaching reform significantly improved the utilization of laboratories and equipment,and significantly enhanced the practical ability of students.     

Role of the embryology laboratory in the human embryonic stem cell line derivation process

With the introduction of regenerative medicine and cell therapy programmes by means of human embryonic stem cells (hESC), several research centres have begun projects of derivation of hESC lines. In some stem cell banks, such as the Andalusian Stem Cell Bank, the law also permits the creation of these cell lines. Therefore, the recovery of cryopreserved embryos, their culture and the subsequent derivation to hESC lines requires a suitable embryology laboratory and specialized and highly qualified staff. Moreover, new techniques, from therapeutic nuclear transfer, need this type of laboratory and staff, too. Several International Associations have drawn up some guidelines for laboratories where embryos are manipulated and they reflect the physical space, the staff and the equipment needed in these kinds of laboratories. Nevertheless, we can see that these guidelines do not distinguish between IVF laboratories and other laboratories that obtain hESC lines, so it would be convenient to make a distinction. Following these guidelines, we have tried to draw up concurrent aspects applicable to areas of embryology within stem cell banks. So, the design and the specific implementation programmes for these areas and other research centres with this area but which do not use IVF techniques is vital to develop embryonic cell lines in optimum conditions for future therapeutic applications, although maybe it is rather premature to standardize this type of research.     

Improving the NHS cervical screening laboratory performance indicators by making allowance for population age, risk and screening interval

OBJECTIVE: One of the key performance measures in the monitoring of the NHS cervical screening programme is the targeting of laboratories with very high or low percentages (outside the 10th-90th percentile) of adequate smears that have moderate dyskaryosis or worse. These laboratories are assumed to include those laboratories that may have extremes of sensitivity and specificity. A clear limitation with this methodology is that laboratories do not examine smears from women with the same underlying risk, age distribution or screening interval and adjustment for these factors should considerably improve the method. METHODS: This paper describes a method that allows for these confounding variables and a new age-risk-interval adjusted moderate dyskaryosis or worse rate (ARI-adjusted mod+ rate) can be calculated. The adjusted rate is the rate of moderate or worse dyskaryotic smears that the laboratory would have detected had it been screening women with an English 'average' age-risk-interval. All laboratories can therefore be compared using this method. RESULTS: The methodology is illustrated using data from the NHSCSP South West Region. The particularly low percentage of moderate or worse smears detected by one or two laboratories can be shown to be due to a local screened population with a very low risk because of a high mean age, relatively short screening interval and census variables associated with a low risk, rather than any under-calling by the associated laboratories. CONCLUSIONS: The ARI-adjusted mod+ rate requires to be calculated for all laboratories in England if it is to be used as a primary performance indicator. Alternatively, it can be used to further examine laboratories that are deemed to be outliers using the current methodology.     

Virtual laboratories in science education: students’ motivation and experiences in two tertiary biology courses

Potential benefits of simulations and virtual laboratory exercises in natural sciences have been both theorised and studied recently. This study reports findings from a pilot study on student attitude, motivation and self-efficacy when using the virtual laboratory programme Labster. The programme allows interactive learning about the workflows and procedures of biological and biochemical experiments, the operation of relevant apparatuses, including the ability to adjust parameters, and the production of results. The programme was used as supplement to mandatory laboratory exercises in two undergraduate courses (i. microbiology and ii. pharmaceutical toxicology) at the University of Southern Denmark. With a theoretical basis in motivational theories, students’ (n = 73) motivation and attitude towards the virtual exercises were evaluated. After completing virtual laboratory cases, the students felt significantly more confident and comfortable operating laboratory equipment, but they did not feel more motivated to engage in virtual laboratories compared to real laboratories. Teachers observed that students were able to participate in discussions at higher levels than in previous years where the programme was not used. The study concludes that virtual laboratories have the potential to improve students’ pre-laboratory preparation.     

Laboratory animal allergens

Allergic sensitivity to laboratory animals can pose a significant occupational hazard to anyone with regular animal contact. Reactions to mice and rats are most common although all furred animals produce allergens that can lead to sensitization and disease. Most of the relevant allergens of laboratory animals have been defined and characterized, which has revealed that these allergens are typically small, acidic glycoproteins and that many of them are members of a superfamily of extracellular proteins called lipocalins. In addition to understanding their molecular characteristics, the identification of these allergens has also made it possible to measure their distribution in laboratory environments and to relate exposure levels to sensitization and symptoms. These studies have shown that the major laboratory animal allergens are carried on small particles that are both capable of remaining airborne for extended periods and penetrating into the lower airways of exposed workers. These advances in the understanding of these important occupational allergens will allow for the development of better methods of diagnosis and avoidance for affected workers and others who may be at risk for future difficulties.     

Risk of occupationally acquired illnesses from biological threat agents in unvaccinated laboratory workers

Many vaccines for bioterrorism agents are investigational and therefore not available (outside of research protocol use) to all at-risk laboratory workers who have begun working with these agents as a result of increased interest in biodefense research. Illness surveillance data archived from the U.S. offensive biological warfare program (from 1943 to 1969) were reviewed to assess the impact of safety measures on disease prevention (including biosafety cabinets [BSCs]) before and after vaccine availability. Most laboratory-acquired infections from agents with higher infective doses (e.g., anthrax, glanders, and plague) were prevented with personal protective measures and safety training alone. Safety measures (including BSCs) without vaccination failed to sufficiently prevent illness from agents with lower infective doses in this high-risk research setting. Infections continued with tularemia (average 15/year), Venezuelan equine encephalitis (1.9/year), and Q fever (3.4/year) but decreased dramatically once vaccinations became available (average of 1, 0.6, and 0 infections per year, respectively). While laboratory-acquired infections are not expected to occur frequently in the current lower-risk biodefense research setting because of further improvements in biosafety equipment and changes in biosafety policies, the data help to define the inherent risks of working with the specific agents of bioterrorism. The data support the idea that research with these agents should be restricted to laboratories with experience in handling highly hazardous agents and where appropriate safety training and precautions can be implemented.     

Laboratory technicians; the Clinical Laboratory Law and its meaning to private physicians

The present laws and regulations relating to clinical laboratories in California are the outcome of over a quarter century of cooperative development. The medical profession, public health department, laboratory workers, and the legislature have worked together in this development.At first the system of certifying technicians and laboratories was on a voluntary basis. The clinical laboratory law in effect legalized and made generally applicable a system which had already been accepted voluntarily. The application of the clinical laboratory law provides physicians a reasonable assurance that competence and reliability will prevail in clinical laboratory operation. Of great importance is the conduct of proper training programs by approved laboratories. Since modern medical practice is so dependent on accurate clinical laboratory work it is essential that special effort be directed by physicians toward influencing young people to enter the profession of medical technology.     

“医学微生物学”本科实验教学中生物安全的落实与实践

"医学微生物学"实验课的主要实验材料是病原微生物,因此实验室生物安全是本课程区别于其它实验课程的重要特征之一。因条件限制,我校以前的"医学微生物学"实验课只能安排在不具备生物安全防护等级的普通实验室中进行,不仅存在安全隐患,也使一部分内容不能正常进行,使医学微生物实验教学的发展遇到了瓶颈。为解决这一矛盾,本研究通过医学微生物学教学师资队伍的培训、实验室硬件条件升级改造以及对课程内容涉及的菌(毒)种及其配套软件建设等一系列措施,建立了具有北京大学医学特色的"医学微生物学"实验教学新体系,保证了微生物实验室生物安全相关法规条例的落实及实验教学的正常进行。     

Laboratory Diagnosis and Characterization of Fungal Disease in Patients with Cystic Fibrosis (CF): A Survey of Current UK Practice in a Cohort of Clinical Microbiology Laboratories

There is much uncertainty as to how fungal disease is diagnosed and characterized in patients with cystic fibrosis (CF). A 19-question anonymous electronic questionnaire was developed and distributed to ascertain current practice in clinical microbiology laboratories providing a fungal laboratory service to CF centres in the UK. Analyses of responses identified the following: (1) current UK laboratory practice, in general, follows the current guidelines, but the scope and diversity of what is currently being delivered by laboratories far exceeds what is detailed in the guidelines; (2) there is a lack of standardization of fungal tests amongst laboratories, outside of the current guidelines; (3) both the UK CF Trust Laboratory Standards for Processing Microbiological Samples from People with Cystic Fibrosis and the US Cumulative Techniques and Procedures in Clinical Microbiology (Cumitech) Guidelines 43 Cystic Fibrosis Microbiology need to be updated to reflect both new methodological innovations, as well as better knowledge of fungal disease pathophysiology in CF; (4) there is a need for clinical medicine to decide upon a stratification strategy for the provision of new fungal assays that will add value to the physician in the optimal management of CF patients; (5) there is also a need to rationale what assays should be performed at local laboratory level and those which are best served at National Mycology Reference Laboratory level; and (6) further research is required in developing laboratory assays, which will help ascertain the clinical importance of ‘old’ fungal pathogens, as well as ‘emerging’ fungal pathogens.     

Shifting paradigms in the history of classical biological control

Classical biological control using insects has led to the partial or complete control of at least 226 invasive insect and 57 invasive weed species worldwide since 1888. However, at least ten introductions of biological control agents have led to unintended negative consequences and these cases have led to a focus on risk that came to dominate the science and practice of classical biological control by the 1990s. Based upon historical developments in the field we consider that the era of focus on benefits began in 1888 and that it was supplanted by an era in which the focus was on risks during the 1990s. This paradigm shift greatly improved the safety of biological control releases but also led to a decline in the number of introductions, probably resulting in opportunity costs. We note here the development of a third paradigm: one in which the benefits and risks of biological control are clearly and explicitly balanced so that decisions can be made that maximize benefits while minimizing risks.     

From cell biology to biotechnology in space

In this article I discuss the main results of our research in space biology from the simple early investigations with human lymphocytes in the early eighties until the projects in tissue engineering of the next decade on the international space station ISS. The discovery that T lymphocyte activation is nearly totally depressed in vitro in 0 g conditions showed that mammalian single cells are sensitive to the gravitational environment. Such finding had important implications in basic research, medicine and biotechnology. Low gravity can be used as a tool to investigate complicated and still obscure biological process from a new perspective not available to earth-bound laboratories. Low gravity may also favor certain bioprocesses involving the growth of tissues and thus lead to commercial and medical applications. However, shortage of crew time and of other resources, lack of sophisticated instrumentation, safety constraints pose serious limits to biological endeavors in space laboratories.     

What's hot in animal biosafety?

In recent years, the emergence or re-emergence of critical issues in infectious disease and public health has presented new challenges and opportunities for laboratory animal care professionals. The re-emergence of bioterrorism as a threat activity of individuals or small groups has caused a heightened awareness of biosecurity and improved biosafety. The need for animal work involving high-risk or high-consequence pathogens and for arthropod-borne diseases has stimulated renewed interest in animal biosafety matters, particularly for work in containment. Application of these principles to animals retained in outdoor environments has been a consequence of disease eradication programs. The anticipated global eradication of wild poliovirus has prompted the promulgation of new biosafety guidelines for future laboratory and animal work. Increased concern regarding the use of biologically derived toxins and hazardous chemicals has stimulated a new categorization of facility containment based on risk assessment. Recognition that prion disease agents and other high-consequence pathogens require safe handling and thorough destruction during terminal decontamination treatment has led to the development of new biosafety guidelines and technologies. The implementation of these guidelines and technologies will promote state-of-the-art research while minimizing risk to laboratory animals, researchers, and the environment.