[Who are the recipients of labile blood products? A multicenter nation-wide study--a "donation day." Blood banks, health facilities]. / Qui sont les receveurs de produits sanguins labiles (PSL)? Une étude nationale multicentrique - un jour donné. Etablissement de transfusion sanguine (ETS) - établissements de santé (ES).

During the years 1994-2001, a progressive decrease of the number of blood units transfused has been reported in France. In contrast, since 2002, there is an increasing number of blood units issuing (+7.6% between 2001 and 2006) and this must be investigated. On behalf of the French Society of Blood Transfusion, the "Recipients" working group promoted a nation wide survey with the support of the regional blood transfusion centres. This survey was aimed at describing the profiles of the transfused patients: socio-demographical patterns, and reasons of the blood transfusion (main and associated diagnoses). A cross-sectional survey was designed. All the patients who received a blood unit during a specific day were considered as the population of the study. They were identified by the regional transfusion centres by means of the "individual issuing form". Survey forms were fully filled for 90% of the patients. It has been considered as a good answer rate. Seven thousand four hundred and twenty-two blood units, delivered to 3450 patients were analyzed. Three groups of pathologies were found as a reason of transfusion: haematology-oncology (52.70% of the prescriptions) with 892 patients (27.8%) for haematological malignancies; surgical procedures (23.99%); intensive care and medicine procedures (21.92%). More than 50% of the recipients are 70 years old and more. This result is explained by the age distribution of inpatients. In a context of lack of donors and consequently difficulties to provide patients with optimal number of blood units, this study is helpful. Variability of blood unit issuings must be detected, analyzed and monitored in real time by the actors of the transfusion process, using computerized dashboards: the blood units provider (in order to adjust the strategy of blood units provision) and the health care establishment as well as care blood components prescribers (reasons of blood transfusion and evaluation of practices).

[Coordination of health vigilances: for a global management of hospital risks]. / La coordination des vigilances sanitaires : pour une gestion plus globale des risques hospitaliers.

The sanitary vigilances represent a permanent sanitary surveillance. They signal, enregister, treat and investigate the adverse events occurring through the use of health products. They assure the traceability of these health products and the management of the sanitary alerts. The sanitary vigilances are part of the sanitary security. They are optimized when coordinated and integrated to the global risk management process of the health care establishments.

[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).

[Transfusion safety and haemovigilance committees]. / Le comité de sécurité transfusionnelle et d'hémovigilance.

Transfusion safety and haemovigilance committees (TSHC) were initially created in the public health care sector. Nowadays, they are also a mandatory committee of private health care institutions. The members of the TSHC, as well as the way the committee is driven and organized, are defined by law. The aim of the committee is focused on the management of transfusion safety and haemovigilance. The TSHC takes part in the improvement of the safety of transfused patients, and monitors the applying of haemovigilance rules. It also handles the training of all staff members involved in the blood transfusion process.

[Evaluation of continuous education in transfusion for professionals in hospitals and clinics]. / Evaluation d'un enseignement en transfusion sanguine proposé aux professionnels des établissements de santé.

Professional health workers need continuous update of knowledge in blood transfusion practice. To fulfill this expectation, the "Etablissement français du sang (E.F.S) Auvergne-Loire", in cooperation with the Department of Regional Affairs in Health Services in the Auvergne region, has set up a proximity-based and a dedicated continuous education course, for more than three years. The content of this update course was based upon regulatory recommendations. The course is one day long; an evaluation of the course by the teachers as well as an evaluation of the teachers' level after the course is carried out. Each course attendant is given a CD-ROM which comprises all of the presentations of the day, along with relevant law texts. We now report on our experience in teaching 127 individual professionals in eight sessions: 95% gave full appreciation. This experience reached - up to now - 53% of the public and private hospitals with transfusion services in the Auvergne region and the Loire district and 90% of structures having remote blood banks. This experience can easily be extended to other regional E.F.S. settings.

[Prevalence of pressure sores in a university hospital in 2003]. / L'escarre à l'hôpital en 2003: enquête de prévalence un jour donné.

BACKGROUND: To determine the prevalence of pressure sores in a university hospital and to assess the risk of developing a pressure sore. METHODS: A one-day survey was performed in all hospitalized patients, day hospital excepted. The Garches scale was used to assess the severity of pressure sores and the Braden scale was used to measure the patient's risk for the development of pressure ulcers. RESULTS: One thousand six hundred and eleven patients were included, mean age was 62+/-23 years and 53.3% were over 65 years old. In hospitalized patients, 64% were in acute care, 29% in intermediate medicine and long-term care and 7% in intensive care units. We have found 675 pressure sores in 268 patients, mean age of 76 years; 263 decubitus ulcers were acquired during hospitalization. The most frequent sites were heels (46%) and sacrum (26%). Stage 1 pressure ulcers showed 33% of the total. The total prevalence was 16.6%, 95% CI (14.9-18.6), the hospital acquired pressure sores prevalence was 7.5%, all stages included. A Braden score less than or equal to 15 was found in 29.1% of hospitalized patients. Standard mattresses were used in 37% of patients with pressure sores. Multivariate analysis showed that age and a Braden score less than or equal to 15 were significantly associated with pressure sores. CONCLUSION: Pressure sores are still an important problem in hospital; occurrence must be considered as an iatrogenic event and management requires a multidisciplinary approach.

Visceral leishmaniosis in HIV-positive patients: primary infection, reactivation and latent infection. Impact of the CD4+ T-lymphocyte counts.

OBJECTIVE: To discriminate cases of visceral leishmaniosis (VL) following a primary infection from cases originating in a reactivation of a latent Leishmania infection and to assess the impact of CD4+ T-cell counts on the occurrence of VL in patients with HIV disease. METHODS: We searched by Western blotting for the presence of Leishmania infantum-specific antibodies in the sera of 236 HIV-positive patients. We performed a follow-up of antileishmanial serology and analysed the evolution of the CD4+ T-cell counts for 14 HIV-positive VL patients and for 18 HIV-positive Leishmania-seropositive patients without VL. RESULTS: This study (1) showed that the VL disease/Leishmania infection ratio in HIV-positive individuals is high (1 : 10); (2) discriminated between a primary Leishmania infection (five patients who converted from Leishmania-seronegative to Leishmania-seropositive) and a reactivation of a latent infection (seven patients); (3) showed that HIV-positive individuals with dramatically low CD4+ T-cell counts maintained or generated a specific antileishmanial antibody production; (4) demonstrated that the primary-VL appeared at significantly higher (P = 0.028) CD4+ T-cell levels than the reactivation-VL; (5) documented the existence of HIV-positive Leishmania-seropositive individuals who despite a severe and prolonged immunosuppression did not develop VL (eight of 18). CONCLUSION: Our data stress the utility of the follow-up by Western blotting for an early diagnosis of VL, and therefore an early treatment, for HIV-positive patients living in endemic areas. They suggest that in a latent Leishmania infection supplementary control mechanism(s) might operate in addition to the T-cell-mediated response, and provide a further example of non-appearance of an opportunistic infection despite a severe reduction in CD4+ T cells.

A sandwich method of enzyme-immunoassay. II. Quantification of rheumatoid factor.

A sandwich enzyme-immunoassay (EIA) has been applied to the determination of the rheumatoid factor (RF). This non-competeitive assay comprises 3 steps: 1) the RF to be assayed is extracted for the biological medium by an immunosorbent of aggregated IgG linked to cellulose; 2) the solid phase is then incubated with the enzyme-labeled aggregated IgG; 3) the enzymatic activity of the immunosorbent is then measured with a suitable chromogenic reagent. This activity is a direct function of the amount of RF to be assayed. This assay gave reproducible results in the range 0.5-50.0 IU/ml. A good agreement was obtained between the EIA and the Waaler-Rose test but no correlation was obtained with the latex slide-test. This assay permits a quantitation of RF with a good reproducibility (coefficient of variation in the range of 10% for moderately elevated values) and thus allows a closer follow-up of patients. The results do not depend on the interpretation of the technician performing the test, which can be easily automated. Finally, it may detect some RF devoid of agglutinating activity.

Measurement of the anti-HIV agent 2',3'-didehydro-2',3'-dideoxythymidine (D4T) by competitive ELISA.

2',3'-didehydro-2',3'-dideoxythymidine (D4T) is a thymidine analogue with potent anti-HIV activity in vitro and is currently being investigated therapeutically in patients with advanced HIV infection. We describe a first one-step competitive ELISA method developed for D4T measurement. Anti-D4T rabbit antibodies were raised against a D4T hemisuccinate-bovine serum albumin immunogen. A D4T-hemisuccinate-horseradish peroxidase conjugate and a monoclonal anti-rabbit IgG antibody insolubilized onto a microtiter plate were used as a tracer and capture system, respectively. The method was capable of detecting 2 ng/ml of D4T in cell cultures and 20 ng/ml of D4T in plasma samples previously separated in microconcentrator devices. Cross-reactivity analysis showed that thymidine, D4T monophosphate, or azidothymidine, were weakly recognized by the ELISA and that thymine or other nucleosides were unreactive. The test was successfully used for the quantification of D4T in cell extracts from CEM or Molt 4 cell lines cultured with D4T and in the plasma of patients with advanced HIV infection, receiving D4T therapy. Moreover this ELISA could be used for the indirect quantification of D4T phosphorylated intracellular metabolites previously separated by reverse phase HPLC and hydrolyzed with alkaline phosphatase.

Use of the leishmanin skin test and western blot analysis for epidemiological studies in visceral leishmaniasis areas: experience in a highly endemic focus in Alpes-Maritimes (France).

Fifty unselected subjects living in Alpes-Maritimes, France, a high risk area for visceral leishmaniasis due to Leishmania infantum, were examined simultaneously by the leishmanin skin test and the Western blot technique in 1993; 32% and 38%, respectively, gave a positive reaction. The concordance of the 2 methods was 82%. Thus, in this high risk area, a large proportion of inhabitants had been exposed to the parasite. The use of these 2 tests should permit the detection of potential cases of reactivated leishmaniasis in prospective follow-up investigations.

Detection by Western blot of four antigens characterizing acute clinical leishmaniasis due to Leishmania infantum.

Western blot analysis of sera from 32 patients with acute clinical leishmaniasis due to Leishmania infantum showed the simultaneous presence of antibodies against 4 antigens with molecular masses of 18, 21, 23, 31 kDa. The simultaneous presence of these 4 antigens was specific to the clinical disease and it was not detected in 47 sera from asymptomatic individuals living in the leishmaniasis endemic area of Alpes-Maritimes (southern France) or in 37 sera from patients with other protozoan infections.

Technical and clinical aspects of cascade filtration plasma exchange (CFPE).

Cascade filtration plasma exchanges (CFPE) were realized using an hemofiltration system (HFS) coupled to 2 filters with different pore sizes. The first one (F1 = plasma-separator; Asahi plasmaflo HI-05) separates plasma from whole blood, the second one (F2 = plasma filter; Asahi XK-60, Kuraray EVAL 2A or 4A) filtrates high molecular weight (MW) components from the separated plasma. F2 filtrate returns to patient mixed with blood cells and 4% Albumin solution or Plasmion R replacing plasma discarded (about 0.5-0.8 I for 1-1.5 plasma mass (PM) treated). The HFS is able i) to modulate the different pressures (venous pressure, F1 and F2 transmembrane pressures (TMp] using pumps speed variators, ii) to recirculate and concentrate extracted plasma and iii) to know F2 treated PM. Blood pressure, pulse rate and electrocardiogram were monitored during each CFPE session. Nineteen CFPE were performed for 8 patients selected among our PE indications, this selection taking into account presence or not of risk factors linked to disease e and/or to patient. Anti-histamine drugs were always infused before CFPE session. On a biological point of view, the problem lies into F2 selectivity which is relatively good for low (as Albumin) and high (as IgM) MW molecules which are returned to patient or discarded, but should be improved for the intermediate ones (as IgG). On a technical point of view, the plasma substitute quantity is reduced about six times. But the control of F2 TMp is not perfectly and the PM to be treated has to be investigated.(ABSTRACT TRUNCATED AT 250 WORDS)

Modelling health care processes for eliciting user requirements: a way to link a quality paradigm and clinical information system design.

Healthcare institutions are looking at ways to increase their efficiency by reducing costs while providing care services with a high level of safety. Thus, hospital information systems have to support quality improvement objectives. The elicitation of the requirements has to meet users' needs in relation to both the quality (efficacy, safety) and the monitoring of all health care activities (traceability). Information analysts need methods to conceptualise clinical information systems that provide actors with individual benefits and guide behavioural changes. A methodology is proposed to elicit and structure users' requirements using a process-oriented analysis, and it is applied to the blood transfusion process. An object-oriented data model of a process has been defined in order to organise the data dictionary. Although some aspects of activity, such as 'where', 'what else', and 'why' are poorly represented by the data model alone, this method of requirement elicitation fits the dynamic of data input for the process to be traced. A hierarchical representation of hospital activities has to be found for the processes to be interrelated, and for their characteristics to be shared, in order to avoid data redundancy and to fit the gathering of data with the provision of care.

[Biovigilance, a vigilance exercised on the utilization of products obtained from the human body]. / La biovigilance, une vigilance exercée sur l'utilisation des produits issus du corps humain.

Organ transplantations and tissue/cells grafts are efficacious in many diseases. Nevertheless, beside the risk due to the technology which permits to carry out transplantations and grafts (surgery, tissue and cells collection, preservation, storage, cell expansion technics, immunosuppressive regimen,...), the microbiology risk must be controlled throughout the process leading to the transplantation or the graft. The structures, the organizations, the procedures, the information network and the controls assure the control of the risk. It is the main objective of human product vigilance. Future regulations will define the objectives of this sanitary vigilance more precisely.

[What is the use of hemovigilance?]. / A quoi sert l'hémovigilance?

The French Blood Agency has developed a national system of surveillance and alert, from blood collection to the follow-up of the recipients, called haemovigilance. The French haemovigilance network is now operational, and aims at detecting, gathering and analysing unexpected or undesirable effects associated with transfusion in order to remedy their causes and prevent their recurrence. Thanks to 1) traceability of blood products from donors to recipients, 2) spontaneous reports of transfusion adverse events, and 3) rigorous management of information related to the transfusion process, haemovigilance effectively contributes to blood 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.

[Materials surveillance, a surveillance performed on the use of medical devices]. / La matériovigilance, une vigilance exercée sur l'utilisation des dispositifs médicaux.

One of the missions of the Agence Française due Sang was to set up a haemovigilance system based on a national network of surveillance and alert, for the whole blood chain from blood collection to receivers' follow-up. This system is now operational and contributes with efficacy to the safety of blood transfusions (see: A quoi sert l'hémovigilance? Transfus Clin Biol 1998; 5: 415-21.). The French law No. 98-535 dated July 1st 1998, whose enforcement orders were published in March 1999, is the legal foundation of the system. In this article the national and regional structures of the national system of sanitary safety are described, and the main guidelines of material vigilance, the last element of this system, is presented.

[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).

[Data interchange in blood transfusion: the impact of a new standard on the evolution of health electronic data exchange in France]. / Echange de données en transfusion sanguine: impact d'une nouvelle norme sur l'évolution de l'EDI santé en France.

The sanitary and social data interchange within care establishments or networks is today the subject of many national or international considerations. Electronic data interchange in the health field has characteristics linked to ethical and deontological principles of care staff. Used daily, this tool contributes to the quality of care, to the optimization of patient treatment and to the organization of the system care. In the transfusion field, the standardization of messages related to the traceability of blood products in now required by the No. 2 instruction of French Blood Agency, which rules the using of national norms elaborated by the French Agency of Normalization. If the technicality is the greater part of these regulated and formalized messages, this standardization systematizes and justifies the nominative and ciphered data interchange in an open environment, opening a new dimension in the interoperability of data system between care establishments. This article analyzes the characteristics and the potential impact of this normalization on the evolution of the electronic data interchange in the health field.