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E Hergon

Publications and source records attributed to E Hergon.

At least 19 recordsLinked to original sources
PubMed2004

[Theoretical risk management and legitimacy of the precautionary principle in medicine. Look back at HIV contamination through blood transfusion in France, twenty years ago].

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.

Acquired Immunodeficiency Syndrome↗
PubMed2004

[Factors of risk perception and risk acceptability: a contribution for the knowledge of the perception of the risk associated with blood transfusion].

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.

Blood Transfusion↗
PubMed2004

[The precautionary principle applied to blood transfusion. What is its impact on practices and risk management?].

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.

Blood Transfusion↗
PubMed2004

[The responsibility of the physician prescriber of blood products].

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.

Blood Component Transfusion↗
PubMed2004

[Legal obligation to inform the patient on the theoretical risk of CJD transmission by blood].

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.

Blood Transfusion↗
PubMed2001

[The fundamentals of precaution].

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.

Australia↗
PubMed2000

[Computer-based hospital transfusion process: why and how does one establish a link between continuous quality improvement and clinical information system?].

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).

Blood Transfusion↗
PubMed2000

[Blood transfusion audit methodology: the auditors, reference systems and audit guidelines].

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.

Blood Banks↗
PubMed1999

[Risk management program in a health facility using a project approach: transfusion risk management].

Risk management in the hospital, which is one of the referentiels of the ANAES accreditation manual, may be considered on two levels. Firstly, risk management may be approached globally, in the same way as it is tackled in the accreditation process. Secondly, risk management may be more definite. A specific risk chosen in accordance with the priorities of a particular plan may be dealt with individually. In this respect, the tranfusion process allows the risk management method to be tested and developed. f1

Blood Banks↗
PubMed1999

[Quality in training].

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.

Blood Transfusion↗
PubMed1998

[Contribution of hemovigilance to immunologic safety of blood transfusions: assessment after 3 years].

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.

ABO Blood-Group System↗
PubMed1998

[The quality audit in a blood transfusion center].

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 Banks↗
PubMed1996

[Quality assurance and prevention of immuno-hemolytic incidents in blood transfusion].

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.

Anemia, Hemolytic↗
PubMed1996

[Improvement of transfusion safety in a health care service through the implementation of a quality program].

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.

France↗