Riv Ital Med Lab (2012) 8:16–25 DOI 10.1007/s13631-012-0037-0

RASSEGNA

Laboratory and occupational medicine: considerations and perspectives regarding biological risk Medicina di laboratorio e occupazionale: considerazioni e prospettive riguardanti il rischio biologico Maria Concetta D’Ovidio • Nicoletta Vonesch • Agnese Martini • Stefano Signorini

Ricevuto: 16 settembre 2011 / Accettato: 20 dicembre 2011 © Springer 2012

Summary Background. We considered some aspects of laboratory medicine and occupational medicine, with special reference to biological risk, looking for those elements that could be essential parts of both medical fields. Methods. We evaluated the national and international literature on biological risk with particular attention to the main features of laboratory and occupational medicine, including errors sources, quality, concept of risk, guidelines and risk reduction. Results. Risk management, training, communication, involvement and participation of different professionals are characteristics of both disciplines, and it is important to promote a risk culture in order to mitigate biological risk. Conclusions. The study of biological risk should include risk assessment and management, through a multidisciplinary approach aimed at eliminating and/or reducing risks. The spread of new methodologies has led to improvement in

M.C. D’Ovidio · N. Vonesch · A. Martini INAIL, Research, Department of Occupational Medicine (formerly ISPESL), Via Fontana Candida 1, 00040 Monte Porzio Catone, Rome, Italy S. Signorini INAIL, Research (formerly ISPESL), Rome, Italy M.C. D’Ovidio (쾷) INAIL, Research, Department of Occupational Medicine (formerly ISPESL), Via Fontana Candida 1, 00040 Monte Porzio Catone, Rome, Italy E-mail: mariaconcetta.dovidio@ispesl; [email protected]

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the study of biological risk and better integration between laboratory and occupational medicine. Key words Biological risk · Workers · Laboratory medicine · Occupational medicine

Riassunto Premesse. Sono stati considerati alcuni aspetti riguardanti la medicina di laboratorio e occupazionale con particolare riferimento al rischio biologico, mettendo in evidenza alcuni elementi che possono essere parti essenziali di entrambi i campi della medicina. Metodi. In tale lavoro è stata studiata la letteratura nazionale e internazionale sul rischio biologico, con particolare attenzione alle principali caratteristiche della medicina di laboratorio e occupazionale: fonti di errori, qualità, concetto di rischio, linee guida, riduzione del rischio. Risultati. La gestione del rischio, la formazione, la comunicazione, il coinvolgimento e la partecipazione di diverse figure professionali sono caratteristiche principali di entrambe le discipline ed è importante promuovere una cultura del rischio al fine di mitigare il rischio biologico. Conclusioni. Lo studio del rischio biologico dovrebbe includere la valutazione e la gestione del rischio, attraverso un approccio multidisciplinare volto a eliminare e/o ridurre il rischio. La diffusione di nuove metodologie ha consentito di migliorare lo studio del rischio biologico e una migliore integrazione tra medicina di laboratorio e medicina del lavoro. Parole chiave Rischio biologico · Lavoratori · Medicina di laboratorio · Medicina del lavoro

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Laboratory and occupational medicine

Considerations regarding occupational medicine

In the past few years laboratory medicine has undergone numerous major changes that have helped to ensure increasingly reliable results, as well as optimizing the execution and duration of analyses, thanks in part to the introduction of so-called innovative methods. Molecular technologies in particular have undergone considerable evolution, leading to the use of biochips, or completely automated systems for analysing biological microsamples [1–4]. The future of microarray-based technologies is promising. With the constant drive of the postgenomic revolution in biomedical research, proteomics is likely to play an even more important role, and microarray-based technologies will continue to be used in a wide range of different applications [5–8]. The development of laboratory methodologies has revolutionized not only the field of general medicine but also many specializations, including occupational medicine [9–16]. It has indeed become increasingly clear that while working in a biomedical laboratory exposes workers to a variety of risks, it is also true that laboratory methodologies have helped to improve the diagnosis of work-related pathologies. Biological risk is a sector that the European Agency for Safety and Health at Work classified among key research priorities in the field of occupational safety and health (WHO) [17]. This report considers “Exposure assessment to biological agents in the workplace”, and asserts that “biological hazards in the work environment have received increasing attention recently due to a number of emerging issues such as bioterrorism, epidemics of treatment resistant tuberculosis in some European countries, an increasing importance of methicillin resistant Staphylococcus aureus (MRSA) in hospital environments, or the occurrence of bovine spongiform encephalopathy (BSE) and consequently possible exposures to workers in meat processing”. Moreover, “Exposure to biological agents also occurs in traditional workplace settings or due to changes in work technologies” [17]. Laboratory medicine is closely related to occupational medicine, not only as an essential instrument for the study of infections, but also as a source of potential risks for laboratory workers. This paper considers some aspects of laboratory medicine in general and focuses on occupational medicine, with special reference to biological risk, highlighting aspects shared between the two fields. In particular, risk management, quality of analytical processes, personnel training and participation, information and communication, examination and verification, are aspects characterizing the two medical disciplines and represent a value acquired by laboratory medicine.

In the field of occupational medicine the need to guarantee quality has grown in recent years, and has been met by so-called risk management [18, 19]. This need will increase with the establishment of innovative methodologies which, on the one hand, are completely automated methods where human intervention is kept to a minimum, and, on the other hand, have to be validated and standardized, with collaboration programmes among different laboratories that seek to raise the reliability of analytical data. Accordingly, guaranteeing quality in the field of occupational medicine is related to the management of the entire process, which obviously includes laboratory methodologies.

Protection of the health of workers exposed to biological risk in the laboratory The most ambitious goal of occupational medicine is to eliminate the risks to which workers can be exposed. In Europe biological risk is governed by Directive 2000/54/EC [20]. In Italy exposure to biological agents is regulated by Title X of Legislative Decree 81/2008 [21] and subsequent Legislative Decree 106/2009 [22, 23], in which all workplaces where this risk may emerge are considered, as well as collective and individual protection measures to be adopted to minimize exposure to such risk.

Reducing exposure Assuming that it is not possible to completely eliminate biological risk, measures must be adopted to safeguard workers’ health and reduce exposure through structural containment and the adoption of behavioural measures by all laboratory staff. Where these measures are insufficient, collective and individual protection devices must be used [24–26]. Examples of collective protective measures are the adoption of biological hoods, and the prohibition of eating and drinking in the laboratory. Personal protective equipment includes gloves, face masks, caps and coats.

Occupational health surveillance One of the main tasks of occupational medicine is health surveillance to prevent occupational and/or work-related pathologies. Laboratory medicine is indispensable for the occupational physician, who can thus use increasingly reliable tools to carry out health surveillance in all work-

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ing phases. Annex IV of Directive 2000/54/EC “Practical recommendations for the health surveillance of workers” underlines the fact that “Further tests may be decided on for each worker subjected to health surveillance, in light of the most recent knowledge available to occupational medicine” [20]. Section V of Italian Legislative Decree 81/08 and further amendments deal with health surveillance of workers. Health surveillance with regard to biological risk has the following aims: clinical-preventive, legal, epidemiological, and fitness to work [27]. As part of preventive health examinations, in addition to the medical check-up and instrumental tests, an important contribution is also made by laboratory tests. As mentioned in Legislative Decree 81/08 and further amendments, the competent physician, following medical examinations, “shall express one of the following opinions regarding the specific job: fitness; partial fitness, temporary or permanent, with prescriptions or limitations; temporary unfitness; permanent unfitness” [21].

Judging fitness to work Providing an opinion on fitness to work is the basic aim of health surveillance. There are varying degrees of fitness, which go towards determining the degree of “compatibility” between the specific work task and the worker. In particular, following the findings of health surveillance, taking into account the worker’s clinical records and the results of instrumental and laboratory analysis, the occupational physician is able to rate a worker as: fit for the job; partially fit, on a temporary or permanent basis, with prescriptions or limitations; or unfit for the job, on a temporary or permanent basis. In recent years judging fitness has been the subject of studies and research which have had the aim, under special conditions, of so-called reintegrating workers, i.e. a form of tertiary prevention in the occupational field. The new frontier of occupational medicine is indeed that of being able to reintegrate workers subjected to occupational prescriptions and enabling them to return to work.

Aspects shared between laboratory and occupational medicine: the concept of risk Issues pertinent to both laboratory and occupational medicine include those related to risk, guidelines, staff training/information, communication and risk mitigation [28–33]. In the field of occupational medicine the term risk may be defined as the likelihood of a harmful event

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occurring in a susceptible population in a given timeframe. In the health-care sector, the question of risk can chiefly be viewed in terms of patient safety, using two types of analysis: one reactive, the other proactive. Reactive analysis entails a subsequent study of accidents, and is aimed at pinpointing causes that allowed an incident to happen, and should be conducted chronologically in reverse. Proactive analysis, on the other hand, seeks to pinpoint and eliminate criticalities in the system before an accident happens, and is based on an integrated qualitative/quantitative analysis of the processes making up the activity. It identifies critical points in order to design safe systems [34–36]. Laboratory medicine must also ensure patient’s safety, in particular by means of correct laboratory diagnosis [37]. The reliability of analytical data is one of the main objectives of laboratory medicine, and can be attained through procedures forming part of the quality management process, which includes: laboratory personnel training, information on methodologies, systems for the calibration and verification of equipment, regular checks, identification and correction of laboratory nonconformities, intra- and interlaboratory meetings, consideration of economic, organizational and efficiency aspects. These aspects of the quality management process represent socalled evidence-based laboratory management, which can be implemented through a number of methodologies [38, 39]. More generally, in the biomedical laboratory, it is necessary to implement risk management, vocational training, clinical auditing, information technology, research, development, management of personnel and resources and patient centrality, which are all components of clinical governance. Within the biomedical laboratory, therefore, numerous components need to be implemented, and the same elements are found in occupational medicine. Terms such as risk management, training, communication, involvement and participation of different professionals, characterizing both laboratory and occupational medicine, need to be transferred and finalized in order to be able to construct an integrated vision regarding each of the two medical disciplines. With this aim, it is fundamental to promote a risk culture within the biomedical laboratory that takes into account not only the risk of giving incorrect analytical data, but also the biological, chemical, physical, carcinogenic risk, etc. Clinical pathology should increasingly be an integral part of occupational medicine, involving not only laboratory personnel but also occupational physicians. It is thus necessary to gauge the effectiveness of actions performed to mitigate risks, not only in laboratory medicine but also in occupational medicine.

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Guidelines

Training and information

The Institute of Medicine (IOM, http://www.iom.edu) has drawn up the guidelines “Clinical practice recommendations, drawn up with a systematic process, with the aim of assisting physicians and patients in deciding on the most appropriate healthcare methods in specific clinical situations”. The best known definition of guidelines is that formulated by the IOM in 1992, that is: “recommendations developed in a systematic manner to help professionals and patients to make decisions on the most appropriate healthcare when dealing with a specific clinical condition” [40, 41]. In Italy the National Guidelines System (http://www. snlg-iss.it) was created by an agreement between the Ministry of Health (http://www.salute.gov.it) and the Istituto Superiore di Sanità (http://www.iss.it), with “the aim of promoting processes to assess and improve the development of diagno stic-therapeutic procedures, through the drafting of Guidelines, policy documents and Consensus Conferences on top priority clinical problems”. With regard to laboratory medicine, it is very important to define the parameters that can guide choices in the best possible way. The drafting and publication of guidelines serves to provide suggested rules of conduct in order to minimize laboratory errors. In 1999 the IOM published a study entitled “To err is human: building a safety health system” [42] that gives three possible ways of reducing errors and applying correct risk management strategies: (1) going from a punitive to a nonpunitive system in order to encourage the voluntary reporting of errors; (2) creating a safety culture and promoting quality based on the prevention and forecasting of errors; and (3) creating a system for singling out and remedying situations at risk of error [43, 44]. In the workplace, biological risk is an area that is still not given top priority, despite the fact that every year about 320,000 workers die around the world as a result of transmissible diseases, 5,000 in the European Union [45]. With reference to guidelines on biological risk in the field of occupational medicine, some websites can be cited, in particular the National Guideline Clearinghouse (NGC, www.guideline.gov), produced by the Agency for Healthcare Research and Quality (AHRQ, www. ahrq.gov) in collaboration with the American Medical Association (AMA, www.ama-assn.org) and with the American Association of Health Plans (AAHP, www.aahp.org). The guidelines are thus, in both laboratory and occupational medicine, steering instruments for the choice of appropriate behaviour and practices to reduce risk.

Current legislation in Italy in the area of occupational health and safety stresses the importance of adequately training and informing all workers. In particular, as mentioned in Legislative Decree 81/08 and further amendments, the employer shall ensure that every worker receives adequate information: “on specific risks to which he is exposed with reference to the working activity performed, safety standards and corporate provisions in place in this sphere; dangers associated with the use of hazardous substances and mixes on the basis of safety datasheets as required by existing legislation and codes of practice; protection and prevention measures and actions adopted”. Furthermore, “the employer shall ensure that every worker receives adequate training on the subject of health and safety, also with regard to a knowledge of the language, with special reference to: concepts of risk, harm, prevention, protection, organization of prevention, rights and duties of company officers, supervisory bodies, control, care; risks relating to job tasks and possible damage and consequent prevention and protection measures and procedures typical of the sector in which the company operates”. The employer must thus ensure that every worker receives adequate training in the area of health and safety; “training and, if applicable, specific training must be given on the occasion of: a) the start of the employment relationship or the start of utilization in the event of the provision of work; b) transfer or change of job tasks; c) introduction of new work equipment or new technologies, new hazardous substances and mixes” [21]. It is important that laboratory staff, as in other working environments, are involved in many aspects of the organization through effective communication and dissemination of information [24, 41–47]. It has been reported that “According to Goldschmidt, if the mission of Laboratory Medicine is to provide clinics with correct, timely information in an adequate format, then it sets itself at least four objectives: 1) diagnostic information must be given (not just numbers); 2) information must be correct (errors are not allowed); 3) information must be timely (not as soon as possible but as useful as possible); 4) information must be adequate (not a column of numbers, but numbers associated, when pertinent, with an interpretation)” [48]. A fundamental characteristic for attaining and maintaining these aims is the application of a quality management system, which has traditionally been tackled in the field of clinical pathology, but has received some attention in the occupational field too, checking results achieved and objectives for maintaining and improving results.

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Risk communication Communication has the inherent characteristic of being inevitable. The first law of communication indeed states that it is impossible not to communicate. Communication must possess some characteristics, including that of reaching all the main referents affected, and be carried out in an effective, strategic, appropriate and transparent manner [49, 50]. In the laboratory setting, as in any other work environment, it is essential to give transparency to the quality of analysis conducted and to adopt a language that is understandable and suitable for the content of the message [51, 52]. To this aim, “the information content must be easy to understand for workers, enabling them to acquire the relative knowledge” [21]. Regarding the risk communication, which is an important concept in both the clinical laboratory and in occupational medicine, a number of variables come into play that need to be kept in mind [30, 53, 54]. The complexity and sensitivity of the message is evident when a patient is told about the possibility of the onset and/or progress of a given pathological condition following a given analytical result, and when workers have to be informed about risks to health and safety in the workplace. It is possible to consider three types of risk communication, that is care communication, consensus communication and crisis communication, and four areas of application, that is communication for the environment, for safety, for health and in event of a crisis or emergency [55–58].

Risk reduction Legislative Decree 81/08 and further amendments establish that general protection measures must entail “the elimination of risks with reference to knowledge acquired through technical progress and, should this prove to be impossible, the reducing of risk to a minimum; reduction of risks at source; adequate information and training for: workers, managers and officers, workers’ safety representatives; adequate instructions to workers; participation and consultation of workers; participation and consultation of workers’ safety representatives; planning of measures deemed to be appropriate for ensuring the improvement of safety levels over time, in part through the adoption of codes of conduct and best practices; emergency measures to be enacted in the event of first aid needs, firefighting, worker evacuation and serious and immediate danger; use of warning and safety signalling; regular maintenance of environments, equipment, plants and machinery, with special reference to safety devices in compliance with manufacturers’ instructions” [21].

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Consequently, one aim should be to minimize risk due to errors that may be committed at various levels of the work process. On this point, in the clinical pathology laboratory in particular, but also in other types of laboratory in different work settings, the automation of equipment and relative computer-assisted management is one way of reducing errors, also bearing in mind the need to implement actions designed to ensure control of the entire analytical and/or productive process [59]. The means for reducing errors provided by automation are basically of two types: greater production capacity and precision of systems, and reductions in variability in single procedures and final product. The rise in reproducibility, and thus the drop in variability of automated processes, also help to reduce the possibility of error. The reduction in variance helps to combat events that deviate significantly from average behaviour, and that can thus be deemed errors; excellent average performance coupled with large variance means that a certain number of unacceptable events will occur [32, 60–62]. On the subject of occupational health the European Agency identified research priorities in 2005, considering that, with reference to occupational biological risk, the “assessment as well as measurement methods for workplace exposures of this kind are still very much at an experimental stage. There are no limit values for occupational exposure to biological agents. There is an urgent need to focus research on biological agents related to workplace exposures. A systematic mapping of these workplaces, encompassing the biology of the microorganisms involved, exposure routes, effects and mechanisms, preventive measures, medical surveillance and rehabilitation proves necessary” [17]. Reducing the risk in both laboratory and occupational medicine must entail the management of prevention [62–67] that includes informing/training, communicating risk, checking learning levels, drawing up guidelines, and planning

Informing/training Workers need to be aware of risks, errors, strategies and methods for reducing and/or eliminating all possible risks. An in-depth knowledge is thus required of all operating procedures, methodologies and instruments regarding work phases that, in the case of laboratories, are made up of preanalytical, analytical and postanalytical phases but that, in other work settings, concern the various processing/production phases. It is accordingly necessary to modify the culture of prevention and safety by means of: education, information, training, retraining, examination, verification performed in an integrated manner, in a multidisciplinary and beneficial context in order to improve the quality of the

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service and satisfy users in the clinical/laboratory as well as clinical/occupational ambits.

Communicating risk Risk should be communicated through an interactive process, entailing the exchange of information and opinions among individuals, groups and institutions, and among persons involved in evaluating and managing health risks, with the aim of making decisions on whether to accept, reduce or avoid the specific risk. Thus, physicians performing laboratory or occupational medicine services, just as other workers, should acquire skills in addition to those of their own area of expertise, that are specific and recognized outside their own occupational ambit. Recently a working group of the “European Communities Confederation of Clinical Chemistry and Laboratory Medicine” (EC4) published a guide to define the skills required of a consultant in clinical chemistry and laboratory medicine for identifying a model of specific activities, comprising clinical practice, the quality of services provided, professional liability, training and research, and management. The list of the 86 skills required, expressed as simple and generic skill standards, is broken down into six main areas: clinical, scientific, technical, communicative, managerial and professional. The most innovative aspect is “the communicative skills needed to be able to communicate effectively within the discipline, with users and with the broader clinical, scientific and political community” [68].

Checking learning levels Learning levels are checked through the carrying out of audits. Clinical audit is one of the main activities employed in the risk management system with reference to both the prevention and resolution of criticalities. The main goals of the audit is to prevent any condition that may lead to an adverse event, to analyse situations that have favoured such an event and to decide on the most appropriate actions for improvement. Training courses for workers to verify their learning progress are undoubtedly a methodology to be followed to ensure the effectiveness of workers’ knowledge levels regarding exposure to specific risk factors in the workplace.

Drawing up guidelines Working groups, scientific societies and institutions should issue guidelines to encourage the exchange of

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multidisciplinary skills, and when drafting guidelines, the views of several observers and experts in different disciplines should be taken into account to obtain an integrated approach to the same problem. Guidelines should take into consideration and give recommendations on sampling, methodologies, result evaluation, best practices, measures to be adopted to minimize various risks of exposure, work organization models, and all information deemed to be useful in terms of appropriateness and risk mitigation.

Planning All organizational, procedural and executive phases of the entire work process need to be planned. Planning makes it possible to be aware of all aspects of different working phases so that measures can be adopted for each phase that are appropriate for reducing risks and protecting the health and safety of workers.

Discussion and conclusions Laboratory testing spread throughout Italy, Europe and America in the 19th century [69, 70]. In Italy in 1868 the first “Clinical chemistry handbook” came out, followed in 1886 by the first “Atlas of clinical microscopy” [71]. In the second half of the 20th century independent chemical/clinical and microbiological analysis laboratories were created [72], and in the new millennium some objectives were set out for laboratories to aim for and attain. Indeed, it was asserted that “the necessary rationalisation of laboratory medicine must be carried out in conjunction with the review of the hospital network, within the framework of an integrated and managed network of services, opening up to all actors of the system and respecting the ‘natural’ population. Effectiveness and efficiency must be closely related: the driving force is appropriateness, in the most modern meaning given to the term. In this sense, we put ourselves forward as the main actors for test selection and laboratory response in a general context (evidence-based medicine and guidelines; measurement of outcomes and auditing) and for the specific patient (reporting and consultancy). We also put ourselves forward as managers, aware of effects and of the organisation that best meets cost-saving and productivity criteria, enhancing disciplinary specificities in activity relating to clinical-laboratory interfacing rather than in routine analytical activity” [73]. The development of traditional methodologies and the spread of new methodological approaches for studying different pathologies have revolutionized the panora-

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ma of laboratory medicine. Traditional technologies such as microscopy have evolved in technological terms, leading to new applications using optical microscopy, stereoscopic microscopy, ultraviolet microscopy, polarized light microscopy, phase contrast microscopy, electron microscopy and scanning electron microscopy [74–78]. Spectrophotometry, a basic methodology used in laboratory medicine, is also now used in a number of applications, as is chromatography, which beginning with socalled normal-phase adsorption chromatography, has been developed to include partition chromatography, paper chromatography, thin-layer chromatography, ion exchange chromatography, affinity chromatography, high-performance liquid chromatography and gas chromatography [79–85]. An important sector is that of immunological methods which, exploiting the principle of precipitation, have led to two-dimensional double gel diffusion, radial gel diffusion and immunoelectrophoresis, while the principle of agglutination has been used to highlight other antigen–antibody reactions [86, 87]. Other methodologies include complement fixation, serum neutralization, immunofluorescence, direct and indirect immunoassays, competitive and non-competitive microparticle enzyme immunoassay, chemiluminescence magnetic immunoassay, radioimmunoassay, enzymelinked immunosorbence assay, fluorescence immunoassay and chemiluminescence immunoassay [88–93]. Molecular methodologies have served to enormously broaden the diagnostic potential of laboratory medicine; such methodologies include southern blotting, northern blotting, polymerase chain reaction (PCR) (with its variants nested PCR, multiplex PCR, real-time PCR, ligase chain reaction, nucleic acid sequence-based amplification and branch DNA), fluorescence in situ hybridization and microarrays [94–100]. At the present time, therefore, a number of methods are used in laboratory diagnostics and, starting with molecular methods, these increasingly involve genomic analyses thanks in part to the identification of numerous genes. The “Human Genome” project has indeed produced not only an immediate effect in terms of studying multiple pathologies, but is also an inexhaustible treasure to be tapped in the future. Currently available genetic bases undoubtedly allow us to take a sophisticated approach to the study of diseases, providing us with a tool that until a few years ago could only be dreamed about. The spread of methodologies such as genomics, proteomics and pharmacogenomics within the sphere of laboratory medicine has brought about an enormous development of instruments that can also be used in the occupational field [101, 102]. The new scenario of laboratory technologies makes constant and continuous professional updating essential

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for the occupational physician who, in order to be able to fully exploit all available methodologies, should first be aware of their existence [103]. Consequently, while laboratory medicine is credited with the ability to see diseases through the biochemistry of cellular metabolic reactions, it is also necessary to pursue the goal of foreseeing the health of both the patient and the worker [104, 105]. The new millennium is likely to stand out for two fundamental trends in the field of diagnostics: the move from seeing to foreseeing diseases, and the move from interpreting health and disease in mutually exclusive terms to interpreting health and disease in a “fuzzy” manner [106–110]. There should thus be the growth of a more dynamic and active culture in the field of occupational medicine so that we are alert to, grasp and exploit everything that can be offered by laboratory technology. The study of biological risk must take these evolutionary trends into account and include in risk evaluation and management the need to adequately communicate risk, a process conceived by the occupational physician and by all prevention actors, and aimed at workers, with the primary goal of improving their state of health. This priority is confirmed in the Constitution of the WHO (WHO, http://www.who.int/en/), the UN agency set up in 1948 with the aim that all populations should attain the highest level of health possible, defining health as “a state of complete physical, mental and social wellbeing and not merely the absence of disease or infirmity”. To achieve this goal it is important to spread the culture of prevention and safety, pursued through adequate information and training. The European Agency, in the document on research priorities, states that “further research is required to determine what factors (at all levels) facilitate or hinder the creation of a successful and sustainable prevention culture” [17]. It is necessary to manage prevention actions in work environments, aimed at eliminating/reducing risks, to provide adequate information/training to workers, managers and officers and to involve everyone called upon to roll out the prevention system [111–113]. In the field of health surveillance “the employer, having consulted the competent physician, shall adopt special protection measures for workers requiring, for personal health-related motives, special protection measures, including making available effective vaccines for workers not already immune to the biological agent present in the laboratory process, to be given by the competent physician”. Furthermore, “the competent physician shall provide workers with adequate information on health monitoring and on the need for check-ups even after the termination of activities, entailing the risk of exposure to particular biological agents listed in appendix XLVI and on the pros and cons of the

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vaccination and of non-vaccination” [21]. For the purposes of prevention in the workplace, special importance is attached to technological progress: “the enormous advances made in the spheres of science and technology in the 20th century have produced a considerable improvement in laboratory analysis methodologies and instrumentation. This trend is likely to continue into the 21st century, resulting in requests for quality guarantees, funding for research and training and radical changes to information technology and online communication” [114]. In conclusion, medicine in the 21st century, in all its specializations, will have to set itself new objectives, taking into account management of prevention. quality of services, rationalization of costs, enhancement of individuals’ professional skills, interdisciplinary dialogue, and dissemination of a safety and prevention culture. These objectives should be directed to all workers employed in various ways to prevent occupational risks in general, and biological risk in particular. Verification, effectiveness tests, best practices, evidence and systematic reviews are all tools to be used in an integrated and multidisciplinary manner: “Emphasizing and practising the role of the laboratory professional as a skilled clinical consultant strongly grounded in evidence as well, in addition to better integration of laboratory and clinical information and improved laboratory reports will overcome most barriers. There is a poverty of good, primary studies of test evaluations. Institution of more consistent standards for the design and reporting of studies on diagnostic accuracy should improve the situation. If nothing else, systematic reviews have demonstrated the need for more good-quality primary research in laboratory medicine” [115]. A better integration of laboratory and occupational medicine makes it possible to improve the management of occupational biological risk. Conflicts of interest None

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