[Check-list "Patient Safety" in the operating room: one year experience of 40,000 surgical procedures at the university hospital of Nice]. / Check-list "Sécurité du patient au bloc opératoire": une année d'expérience sur 40 000 interventions au centre hospitalier universitaire de Nice.

OBJECTIVES: The implementation of the check-list "Safe surgery saves live" (CL) has proven effective to reduce morbidity and perioperative mortality. Since 1st January 2010 it is a requirement of the HAS as part of the process of certification of hospitals. The CL has been established on all the operating rooms of our hospital after the onset of a near accident. METHODS: The CL has been computerized to facilitate its adoption by professionals. An internal benchmarking was immediately implemented to allow each surgical specialty to benchmark themselves with other teams. We conducted an audit concerning the CL and periodic assessments in order to learn more precisely concerning the expectations and feelings of medical and nursing teams. RESULTS: Nearly 40 000 CL were collected in the patient record. The completeness of information of some items seems to reflect the difficulty for professionals to realize the difference between traceability and information sharing within the team on the implementation of a protocol. This audit has confirmed the difficulty in sharing information orally. CONCLUSIONS: The CL is involved in developing a safety culture in the operating room and led to the establishment of a risk mapping in the operating room and the recovery room and participation in the program error prevention procedure and surgical site through international program "High 5s" whose purpose is to improve the safety of care.

[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.

[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.

[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.

[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).

[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.

[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.

[Are the indications and choice of labile blood products adapted? National survey on prescriber's knowledge]. / Les indications et le choix des produits sanguins labiles sont-ils adaptés? Enquête nationale sur les connaissances des prescripteurs.

OBJECTIVE: There is little data available on current practice related to prescription of labile blood products (LBP) by French physicians. The aim of this study was to assess whether prescriptions were conform to Anaes (French Medicine's agency) guidelines, with regard not only to indications but also quality of the products, so as to define the improvements that could be made. METHOD: Thirty-four clinical case reports, classified by specialties were sent to prescribing physicians working in the regional health centers, from 17 different blood banks, from October 1997 to February 1998. The prescribers were requested to answer only the questions that were specific to their particular field of experience. Each case description included multiple choice questions on the indication for transfusion of concentrated of red blood cells (RBC) and/or platelets (CP) and/or plasma, and the possible requirements for specification or modification of the guidelines applicable to these products. The primary end point of analysis was the adequation of the answers to the Anaes recommendations. RESULTS: Answers were obtained regarding 5092 clinical cases from 818 physicians. The participation rate was of 30%. The specialties were as follows: 34% anesthesiologists, 14% oncologists-haematologists, 13% internal medicine specialists, 11% emergency physicians, 10% paediatricians, 8% obstetricians, 7% geriatricians, and 3% transplantation surgeons. Eighty-two percent of the answers came from physicians working in the public health services. The adequation with the indication for transfusion was of 90.3% for RBC, 92.3% for platelets and 93.8% for plasma. The percentages of correct answers regarding the indications for specification or modification of the LBP were as follows: 90.3% were correct for irradiation (of either RBC or platelets); 68.8% and 53.2% respectively for leukocyte depletion from RBC and platelets; 64% for phenotyped RBC; 68.2% for compatibilized RBC; and 57.3% for apheresis platelet concentrates. There was no difference in results depending on the type of center, private or public, and the quality of LBP prescribed. The answers obtained from the anaesthesiologists' clinical cases were less accurate with regard to RBC but more accurate with regard to PC compared with other specialists. CONCLUSION: This study shows the correct management of the indications for transfusion by the prescribing physicians who participated in the study, but the lack of knowledge with regard to the indications for specifications and/or transformations of LBP. The respect of the indications for transfusion is the corner stone of safe transfusion and this phase should be optimized with improved dissemination of information on transfusion and training for the physicians and programs that would improve the quality.

[How the information system can contribute to the implementation of a risk management program in a hospital?]. / Comment le système d'information peut-il aider un programme de gestion des risques en établissement de santé?

Nowadays, information system is recognised as one of the key points of the management strategy. An information system is regarded conceptualised as a mean to link 3 aspects of a firm (structure, organisation rules and staff). Its design and implementation have to meet the objectives of medical and economical evaluation, especially risk management objectives. In order to identify, analyse, reduce and prevent the occurrence of adverse events, and also to measure the efficacy and efficiency of the production of care services, the design of information systems should be based on a process analysis in order to describe and classify all the working practices within the hospital. According to various methodologies (usually top-down analysis), each process can be divided into activities. Each activity (especially each care activity) can be described according to its potential risks and expected results. For care professionals performing a task, the access to official or internal guidelines and the adverse events reporting forms has also to be defined. Putting together all the elements of such a process analysis will contribute to integrate, into daily practice, the management of risks, supported by the information system.

[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.

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.

Towards health care process description framework: an XML DTD design.

The development of health care and hospital information systems has to meet users needs as well as requirements such as the tracking of all care activities and the support of quality improvement. The use of process-oriented analysis is of-value to provide analysts with: (i) a systematic description of activities; (ii) the elicitation of the useful data to perform and record care tasks; (iii) the selection of relevant decision-making support. But paper-based tools are not a very suitable way to manage and share the documentation produced during this step. The purpose of this work is to propose a method to implement the results of process analysis according to XML techniques (eXtensible Markup Language). It is based on the IDEF0 activity modeling language (Integration DEfinition for Function modeling). A hierarchical description of a process and its components has been defined through a flat XML file with a grammar of proper metadata tags. Perspectives of this method are discussed.

Integration of health care process analysis in the design of a clinical information system: applying to the blood transfusion process.

Hospital information systems have to support quality improvement objectives. The requirements of the system have to meet users' needs in relation to both the quality (efficacy, conformity, safety) and the monitoring of all health care activities (traceability). Information analysts need complementary methods to conceptualize clinical information systems that provide actors with immediate individual benefits and guide collective behavioral changes. A methodology is proposed to elicit users' needs using a process-oriented analysis, and it is applied to the field of blood transfusion. We defined a process data model, the main components of which are: activities, resources, constrains, guidelines and indicators. 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 this approach to be generalised within the organisation, for the processes to be interrelated, and for their characteristics to be assessed.

[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).

[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.

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

Hospital information systems have to support quality improvement objectives. The design issues of health care information system can be classified into three categories: 1) time-oriented and event-labelled storage of patient data; 2) contextual support of decision-making; 3) capabilities for modular upgrading. 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 conceptualize 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 field of blood transfusion. An object-oriented data model of a process has been defined in order to identify its main components: activity, sub-process, resources, constrains, guidelines, parameters and indicators. 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 this approach to be generalised within the organisation, for the processes to be interrelated, and for their characteristics to be shared.

[Risk management program in a health facility using a project approach: transfusion risk management]. / Un programme de gestion des risques dans l'établissement de santé à travers une démarche par projet: la gestion du risque transfusionnel.

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

Occurrence of Leishmania infantum parasitemia in asymptomatic blood donors living in an area of endemicity in southern France.

Visceral leishmaniosis (VL) due to Leishmania infantum (L. chagasi) is a lethal disease if untreated, but asymptomatic L. infantum infections have been reported previously. A better understanding of parasite transmission, dissemination, and survival in the human host is needed. The purpose of this study was to assess whether L. infantum circulated in peripheral blood of subjects with no history of VL. Sera from 565 blood donors were screened by Western blotting to detect Leishmania-specific antibodies and identify individuals with probable past exposure to Leishmania. Seropositivity was found in 76 donors whose buffy coats were examined by PCR and direct culture. The parasite minicircle kinetoplast DNA was amplified from blood samples of nine donors. Promastigotes were detected by culture in blood samples from nine donors. Only two donors were PCR and culture positive. These results indicate that L. infantum circulates intermittently and at low density in the blood of healthy seropositive individuals, who thus appear to be asymptomatic carriers. Implications for the safety of blood transfusion are discussed.