[A structured ePortfolio to handle a programme of professional competences assessment in the area of transfusion medicine]. / Un portfolio électronique structuré pour la gestion et le suivi des dossiers d'évaluation des pratiques professionnelles en technique et médecine transfusionnelles.

In order to organize a nationwide program for the evaluation of professional practices in the area of blood transfusion, the French National Blood Transfusion Institute and the Nice-Sophia Antipolis University designed and implemented a web based service aimed at following-up and guiding the physicians involved in such an assessment program. The core component is a structured electronic portfolio (ePortfolio), the implementation of which was based on an object-oriented environment combined with a content management system. The modelling of the global evaluation system makes it possible to describe this type of portfolio according to six axes: an axis "objectives" (competencies accreditation); an axis "target" (heath care professionals); an axis "content" (numerical documents); an axis "structure" (matrix of answer defined in space and time); an axis "source" (single source peer-reviewed); an axis "level of evidence" (validation of the proof after its deposit by an identified and authenticated peer user, whole tracking of the exchanges and interactions between users and device).

[Theoretical risk management and legitimacy of the precautionary principle in medicine. Look back at HIV contamination through blood transfusion in France, twenty years ago]. / La gestion d'un risque potentiel et la légitimité du principe de précaution en médecine. Regard vingt ans après sur la contamination transfusionnelle par le VIH en France.

The precautionary principle first appeared in France during the health crisis following the contamination of patients with HIV via blood transfusion. This study analyses whether the risk associated with blood transfusion was taken into account early enough considering the context of scientific uncertainty between 1982 and 1985. The aim was to evaluate whether a precautionary principle was applied and whether it was relevant. First, we investigated the context of scientific uncertainty and controversies prevailing between 1982 and 1985. Then we analysed the attitude and decisions of the French authorities in this situation to determine whether a principle of precaution was applied. Finally, we explored the reasons at the origin of the delay in controlling the risk. Despite the scientific uncertainties associated with the potential risk of HIV contamination by transfusion in 1983, we found that a list of recommendations aiming to reduce this risk was published in June of that year. In the prevailing climate of uncertainty, these measures could be seen as precautionary. However, the recommended measures were not widely applied. Cultural, structural and economic factors hindered their implementation. Our analysis provides insight into the use of precautionary principle in the domain of blood transfusion and, more generally, medicine. It also sheds light on the expectations that health professionals should have of this principle. The aim of the precautionary principle is to manage rather than to reduce scientific uncertainty. The principle is not a futile search for zero risk. Rather, it is a principle for action allowing precautionary measures to be taken. However, we show that these measures must appear legitimate to be applied. This legitimacy requires an adapted decision-making process, involving all those concerned in the management of collective risks.

[Global risk management]. / Gestion globale des risques.

Risk management is a fundamental component of any successful company, whether it is in economic, societal or environmental aspect. Risk management is an especially important activity for companies that optimal security challenge of products and services is great. This is the case especially for the health sector institutions. Risk management is therefore a decision support tool and a means to ensure the sustainability of an organization. In this context, what methods and approaches implemented to manage the risks? Through this state of the art, we are interested in the concept of risk and risk management processes. Then we focus on the different methods of risk management and the criteria for choosing among these methods. Finally we highlight the need to supplement these methods by a systemic and global approach including through risk assessment by the audits.

[The quality audit in a blood transfusion center]. / L'audit qualité dans l'établissement de transfusion sanguine.

A quality audit is a systematic and independent examination used to determine whether quality activities and related results comply with planned arrangements, and whether these arrangements are implemented effectively and are suitable to achieve objectives. It typically applies to, but is not limited to, a quality system or elements thereof, to processes, products or services. Such audits are often called "quality system audit", "process quality audit", "product quality audit" or "service quality audit". Confidence is necessary between the quality auditor and auditees. In blood transfusion, the audit is a tool for improvement and risk management of processes, products or services.

[Blood transfusion and quality assurance]. / Transfusion sanguine et assurance de la qualité.

Administrating safe blood products and being able to produce the evidence of procedures correctly employed, is today vital for healthcare professionals. Industrial quality assurance is an appropriate answer to this problem. Indeed, this approach allows the mastering of a processing system thanks to the combination of three elements: a detailed description of processes, control mechanisms and corrective measures. It relies on an information system and must be applied to all steps of blood transfusion.

[Contribution of hemovigilance to immunologic safety of blood transfusions: assessment after 3 years]. / Apport de l'hémovigilance a la sécurité immunologique des transfusions sanguines: bilan après 3 ans.

The haemovigilance system has indirectly introduced three types of information: a more precise tally of accidents and risks (even if the total number of events remains difficult to assess); an evolution of the mode of collecting relevant information (even if, after 3 years, it has become important to define new objectives and collection procedures); the identification of the main causes of errors leading to immunological accidents allowing the elaboration of schemes pointing out the possible failures and critical points of the various processes, such as blood bag distribution, ABO control at bedside, the prescription of examinations prior to transfusion. The analysis of haemovigilance data has induced a number of important consequences, particularly clinical practitioners' awareness of blood transfusion risks; elaboration of reliable and documented tools for the training of professionals and the information of patients; implementation of corrective and preventive measures, particularly to reduce accidents due to ABO incompatibility. These haemovigilance data will provide more fruitful results when cross-analysed with data from the reactovigilance system which is being set up. Until then, they will largely be used to elaborate blood transfusion quality assurance standards.

[Failure mechanisms in the transfusion process. Importance of anticipatory operational safety analysis]. / Modes de défaillance du processus transfusionnel. Intérêt de l'analyse prévisionnelle de sûreté de fonctionnement.

The methods used for the safety previsional analysis of operations represent an interesting set of tools to follow the so-called transfusion process, defined as all the steps from donors sensitization to recipients follow-up. FMECA (Failure Mode Effects and Criticality Analysis) can be used as a prevention tool, independently of any dysfunction in the process. Of course, it can also be used following a failure, in order to analyse its causes and to apply specific corrections. Operation safety, quality insurance, epidemiologic surveillance and safety monitoring act in synergy. These three aspects of transfusion safety constitute a dynamic system.

[Preventing deficiencies in the transfusion process]. / La prévention des défaillances du processus transfusionnel.

The methods of system reliability analysis represent an interesting set of tools used to follow the so-called "transfusion process", defined as all the steps from donors sensitization to recipients follow-up. FMECA, (Failure Mode Effects and Criticality Analysis), can be used as a prevention tool, independently of any dysfunction in the process. Of course, it can equally be used following a failure, in order to analyse the causes and to apply the specific corrections. Quality insurance, system reliability analysis, epidemiologic surveillance and safety monitoring operate in synergy. These three issues pertaining to transfusion safety constitute a dynamic system.

[Blood transfusion audit methodology: the auditors, reference systems and audit guidelines]. / La méthodologie de l'audit en transfusion sanguine: auditeurs, référentiels, guide de l'auditeur.

The audit has become an essential aspect of the blood transfusion sector, and is a management tool that should be used judiciously. The main types of audit that can be envisaged in blood transfusion are the following: operational audit concerning a predetermined activity; systems quality audit; competence audit, combining the operational audit on a specific activity with quality management, e.g., laboratory accreditation; audit of the environmental management system; and social audit involving the organization of an activity and the management of human resources. However, the main type of audit considered in this article is the conformity audit, which in this context does not refer to internal control but to conformity with an internal guideline issued by the French National Blood Service. All audits are carried out on the basis of a predescribed method (contained in ISO 10 011). The audit is a system of investigation, evaluation and measurement, and also a means of continuous assessment and therefore improvement. The audit is based on set guidelines, but in fact consists of determining the difference between the directions given and what has actually been done. Auditing requires operational rigor and integrity, and has now become a profession in its own right.

[Quality in training]. / La qualité en formation.

Knowledge has become an essential resource in developed societies, and hence the role of training has become ever more important. Training is the basis of professional proficiency. This is of particular interest in a public service such as blood transfusion, which is rapidly developing. To remain competent, a professional must regularly update his (her) basic knowledge. This requires an efficient training support. To implement a quality assurance system in a training center, several factors must be considered: the choice of a reference system; the evaluation of the customer's needs; the control and the assessment procedures.

[Factors of risk perception and risk acceptability: a contribution for the knowledge of the perception of the risk associated with blood transfusion]. / Les facteurs de perception et d'acceptabilité du risque: un apport pour la connaissance des représentations du risque transfusionnel.

The concept of risk cannot be limited to simply knowing the probability of occurrence and the seriousness of the damages caused. It's a matter of social construction and numerous elements contribute towards its perception and acceptability. These elements have been studied for 20 years or so. Some of these elements influence risk perception such as awfulness, unfamiliarity, the number of people exposed to it, other elements influence its acceptance such as individual perceptions, social factors, ethics and equity. Their knowledge allows a better understanding of the evolution of perception and of the risk acceptability in general and transfusion risk in particular.

[Legal obligation to inform the patient on the theoretical risk of CJD transmission by blood]. / L'obligation d'informer le patient sur le risque potentiel de transmission de la MCJ par voie sanguine.

Legal obligation to inform the patient does not include theoretical risks. However, due to the very sensitive situation of blood transfusion in France, following the tainted-blood affair, a circular was issued to extend this obligation (1998) to inform the theoretical risk of CJD transmission by blood. Ethically speaking, this raises three questions: Is it beneficial to the patient to be informed on theoretical risk? Is the use of a "circular", less legally binding, appropriate? Finally, what is the situation in other countries? The evolution of the law tends to be more positive in that it no longer involves any theoretical risk.

[The fundamentals of precaution]. / Les fondements de la précaution.

The precautionary principle appeared in the health vocabulary, especially in blood transfusion, at the beginning of the 1990s. It is applied to potential risks in case of scientific doubt and corresponds to an hypothesis of risk that must be completely distinguished from the case of an exceptional residual risk. This principle lies on two innovations: the breach of the link between scientific knowledge and decision, and the creation of a context for a new normative value. Because of their consequences, these innovations should generate a debate between professionals about the caution principle's foundations, its conditions of application, and its judicial drawbacks. This article, mainly dealing with the foundations of caution, will also present the social construction of the precaution, its judicial aspects, as well as the change in the relationship to risks induced by it.

[Computer-based hospital transfusion process: why and how does one establish a link between continuous quality improvement and clinical information system?]. / Informatisation du processus transfusionnel à l'hôpital: pourquoi et comment établir le lien entre amélioration continue de la qualité et système d'information clinique?

Within a hospital, the need for a computer-based transfusion system has became mandatory. It facilitates the tracing of healthcare activities, which is the basis of the security of the care and a functional element of continuous quality improvement procedures. In order to implement this traceability, reactive and real-time information systems are needed close to healthcare participants, which is not the case of current information systems which rely on a recorded collection of data, far from the needs of the caregiver, and mainly answering to an objective evaluation of results. In the context of continuous quality improvement programmes started in our hospital, hemovigilance was the first to use a process analysis approach, from the prescription of blood units to their administration and follow-up. Several questions arise from this: 1) how to use the process analysis work to specify the users' needs of a generalized and real-time transfusion information system? 2) how to spread this model to other healthcare activities? 3) how to integrate or interface the whole of these quality programmes with a clinical information system? A user-centered methodology was used, based on 'usage cases'. For each step of the transfusion process, this method allowed us to specify participants, data necessary for an activity (observed, deduced or decision-support data), data issuing from the activity, roles (the interaction between user and activity) and functions (the result of the interaction between user and activity).

[Immuno-hemolytic transfusion reactions. IV. Analysis, risks and prevention]. / Les accidents immuno-hémolytiques transfusionnels. IV. Analyse, risques et prévention.

The immunological risk of red blood cell transfusions now seems higher than the viral risk. According to studies, severe accidents due to blood incompatibility occur with a frequency estimated at 1/6000 to 1/29000; despite technical progress, the risk does not significantly diminish. The majority of accidents do not originate from laboratory or production stages but from defects in the application of clinical procedures. Preventive measures are based on (i) the elaboration of clinical guidelines, (ii) the compliance to strict rules in carrying out bedside ABO check, and (iii) the realization and interpretation of antibody screening tests. The implementation of quality assurance systems and of the epidemiological surveillance system, which define the basis of a prevention policy, leads to the expectation of an improvement of transfusion safety.

[The responsibility of the physician prescriber of blood products]. / La responsabilité du médecin prescripteur de produits sanguins labiles.

Blood transfusion presents mainly virological, bacteriological, immunohaematological and volemic risks; with the latter two particularly concerning health establishment employees. This article tackles the physician's responsibility in blood transfusion. Taking into account the regulations that surround the activity, prescribing physicians must know and put into action the relative requirements in their practises in order to avoid taking on its responsibility, or that of the health establishment in which they work, as any lack of respect for the rules and regulations could result in being held liable for any side affects suffered by the patient. The article has the objective of identifying the main regulation requirements in order to control them despite a difficult environment, from the point of view of patients' rights regarding the benefits and the consequences of transfusion. These requirements focus mainly on information and patient consent, the prescription of blood products as well post transfusion information and the follow-up care. Proof of respect for these rule requirements must be available for each of these aspects.

[Immunologic risks of blood transfusion and public health]. / Risque immunologique en transfusion sanguine et santé publique.

The general objective is the study, through scientific approaches, of the main components of immunological risks linked to red blood cell transfusions, as well as their consequences, in order to define precise rules for prevention, taking into account that 2,700,000 units were transfused in 1992. To reach this general aim, five intermediary objectives have to be achieved: 1) The sentinel study of the methodology used to collect information about transfusion accidents, as well as their identification and their early clinical expression; 2) The analysis of the occurrence mechanisms of incompatibilities and transfusion accidents; 3) The up-date definition of post-transfusion alloimmunization, in particular regarding 3 parameters: a) the immunogenicity of the different erythrocyte antigens, that will have to be reassessed; b) the modes of occurrence of post-transfusion anti-erythrocyte alloimmunization; c) the different types of chronology in the appearance and the persistence of anti-erythrocyte antibodies. 4) The search for significant criteria in order to assess the immunopathological correlations of the consequences of antigen-antibody conflicts; 5) The elaboration of the principles for tests evaluation and identification of the techniques linked to blood groups and the study of anti-erythrocyte antibodies.

[The precautionary principle applied to blood transfusion. What is its impact on practices and risk management?]. / Le principe de précaution appliqué à la transfusion sanguine: quel impact sur les pratiques et la gestion des risques?

The precautionary principle has boomed in the French public health sector through blood transfusion. There has been, however, no perambulatory reflection on the definition, objectives, methods of application or consequences of this principle. The question of the pertinence of its application remains unanswered. This study, based on interviews with blood transfusion practitioners, aims to establish their perceptions of the precautionary principle's application in this specific field and of its consequences in terms of risk management and patients' rights. The pros and cons of this application are analysed based on these perceptions. According to our analysis, the precautionary principle seems to be born of confusion. It is seen more as a way to protect decision makers than patients and, if taken to extremes, could prejudice medical logic. Nevertheless, it also brings measures which renew and encourage evolution in transfusion risk management.

[Improvement of transfusion safety in a health care service through the implementation of a quality program]. / Amélioration de la sécurité transfusionnelle dans un établissement de santé par le développement d'une démarche qualité.

The quality policy brings with it an efficient method as well as relevant tools to improve transfusion safety in health care services. This article illustrates the details of the approach through the presentation of a project developed in the East Picardie region throughout several hospitals. It underlines the importance of the choice of a good reference system, of a pertinent method and the necessity of a real project management. Furthermore, the follow-up of the project has enabled us to identify a certain number of success criteria in the steering of the changing process.

[Quality assurance and prevention of immuno-hemolytic incidents in blood transfusion]. / Assurance de la qualité et prévention des incidents immuno-hémolytiques en transfusion sanguine.

Direct and indirect measures of the reliability of the transfusion process are described. These measures can be used to assess the improvement of the transfusion process with a view to preventing hemolytic incidents. Quality assurance arrangements required by their use are made clear. The stress is put upon four points: processes must be formalized and standardised; quality audits must become a routine part of the transfusion process; the system of error reporting must be extended to include all failures; anonymity must be insured to improve reporting.