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The French National Authority for Health (HAS) recently issued guidelines for patient blood management (PBM) in surgical procedures. These recommendations are based on three usual pillars of PBM: optimizing red cell mass, minimizing blood loss and optimizing anemia tolerance. In the preoperative period, these guidelines recommend detecting anemia and iron deficiency and taking corrective measures well in advance of surgery, when possible, in case of surgery with moderate to high bleeding risk or known preoperative anemia. In the intraoperative period, the use of tranexamic acid and some surgical techniques are recommended to limit bleeding in case of high bleeding risk or in case of hemorrhage, and the use of cell salvage is recommended in some surgeries with a major risk of transfusion. In the postoperative period, the limitation of blood samples is recommended but the monitoring of postoperative anemia must be carried out and may lead to corrective measures (intravenous iron in particular) or more precise diagnostic assessment of this anemia. A "restrictive" transfusion threshold considering comorbidities and, most importantly, the tolerance of the patient is recommended postoperatively. The implementation of a strategy and a program for patient blood management is recommended throughout the perioperative period in healthcare establishments in order to reduce blood transfusion and length of stay. This article presents an English translation of the HAS recommendations and a summary of the rationale underlying these recommendations., (Copyright © 2024. Published by Elsevier Masson SAS.)

Objectives: Low-viscosity bone cement impregnated with gentamicin is frequently used to fix femoral prostheses. Three cardiac arrests occured successively during cementoplasty oh hip replacements, leading to the death of two patients. The objective of this study is to describe the actions undertaken to establish a potential link between the use of the bone cement and the occurrence of these serious adverse events (SAE)., Methods: A mortality and morbidity review was organised in order to study the causality of bone cement and to propose improvement actions, following 3 considered SAE associated to materiovigilance reporting., Results: All three SAE occurred following the injection of the same reference of bone cement. The incriminated batches were rapidly placed in quarantine. Analysis by the manufacturer revealed no defects in production quality requirements but suggested the possibility of Bone Cement Implantation Syndrome (BCIS). A literary review on BCIS confirmed that this rare intraoperative complication was plausible in all three cases. Management of these SAE via a health care safety process enabled to provide a rapid answer concerning the causality of the cement and practice deviations of its use., Conclusions: Systemic analysis completed by the manufacturer's analysis provided corrective actions for professional practices. Implementation and efficacy of these actions will be monitored as part of the facility's programme for the improvement of quality and patient safety., (Copyright © 2023 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.)

Background: Traumatic hemorrhage guidelines include point-of-care viscoelastic tests as a standard of care. Quantra (Hemosonics) is a device based on sonic estimation of elasticity via resonance (SEER) sonorheometry to assess whole blood clot formation., Objectives: Our study aimed to assess the ability of an early SEER evaluation to detect blood coagulation test abnormalities in trauma patients., Methods: We conducted an observational retrospective cohort study with data collected at hospital admission of consecutive multiple trauma patients from September 2020 to February 2022 at a regional level 1 trauma center. We performed a receiving operator characteristic curve analysis to determine the ability of the SEER device to detect blood coagulation test abnormalities. Four values on the SEER device were analyzed: clot formation time, clot stiffness (CS), platelet contribution to CS, and fibrinogen contribution to CS., Results: A total of 156 trauma patients were analyzed. The clot formation time value predicted an activated partial thromboplastin time ratio of >1.5 with an area under the curve (AUC) of 0.93 (95% CI, 0.86-0.99). The AUC of the CS value in detecting an international normalized ratio of prothrombin time of >1.5 was 0.87 (95% CI, 0.79-0.95). The AUC of fibrinogen contribution to CS to detect a fibrinogen concentration of <1.5 g/L was 0.87 (95% CI, 0.80-0.94). The AUC of platelet contribution to CS to detect a platelet concentration of <50 G/L was 0.99 (95% CI, 0.99-1.00)., Conclusion: Our results suggest that the SEER device may be useful for the detection of blood coagulation test abnormalities at trauma admission., (© 2023 The Author(s).)

Competing Interests: Déclaration de liens d'intérêts Les auteurs déclarent ne pas avoir de liens d’intérêts.

Flow regulators are widely used in hospitals to assist with intravenous (IV) infusion of medication. The rupture of a flow regulator at the base of the clamp was observed during parenteral nutrition. This rupture resulted in fluid leakage and an inlet of air, responsible for an air embolism in a fragile patient who had undergone a bilateral lung transplant. The patient's clinical condition required him to be transferred to a continuous monitoring unit. A serious Adverse Event in Healthcare (AEH) was reported, as well as a medical device vigilance report. A Feedback Committee (FC) was set up and it recommended an audit within the health care departments to study the conditions for use of flow regulators and to propose corrective actions. Despite the technical data sheet of the device not recommending the administration of lipid emulsions and glucose solutions above 10%, the manufacturer's expert report concluded that the mechanical failure could not be linked to the type of solution. However, the audit did reveal a lack of knowledge of certain rules for using this device. The analysis of this AEH is part of the establishment's patient safety procedure. The AEH highlighted a deviation in care concerning the conditions for use of flow regulators, thus resulting in misuse. The collaboration between the various actors involved in the analysis of this AEH led to the implementation of improvement actions on the root causes, related to the lack of information and of training for professionals on correct use of the medical device.

Treatment by blood transfusion first requires an intravenous cannula. Professionals remember the optimal diameter for transfusion (16 to 18G). Practices differ according to the department concerned. Neonatology and paediatric wards use precision filters and put in fine cannulas (24G) with the constraint that this restricts transfusion flow rate. In haematology and oncology departments, the state of the patient's veins has to be considered when administering chemotherapy which may be toxic for vascular endothelium and the implantation of a venous port by a critical care anaesthetist may be suggested. Emergency departments use central venous catheters, blood warmers and, exceptionally, intraosseous infusion which is now being used again. Haemodialysis requires repeated vascular access making the creation of arteriovenous fistula necessary. We wanted to have an overview of all the different techniques potentially used in the departments of a health institution. These medical devices are managed by the pharmacies in our institutions., (Copyright © 2018 Elsevier Masson SAS. All rights reserved.)

The decision of November 6th, 2006 defining the principles of best practices recommends that posttransfusional red cell alloantibodies research is performed after one to three months after. In the University hospital of Brest, the haemovigilance unit takes charge of sending the medical prescription within the required time and centralizing the results. We wished to estimate if the realization of this research still remains relevant., Methods: A prospective analysis was performed in 2015. We evaluated the realization rate, the red cell alloantibodies rate and the recipient adverse reactions with the diagnostic category: alloimmunization (delayed serological transfusion reaction, DSTR)., Results: In 2015, 2162 prescriptions were sent to the 3271 transfused patients. One thousand and eighteen red cell alloantibodies research were done, i.e. a return rate of 61%. Among them, 12 alloantibodies appeared (0.9%) within an average of 56 days. Thirty-three other alloantibodies appeared and were discovered most frequently before a new transfusion. In 10 cases, a posttransfusional research was done that was negative. A survey was conducted among GHCOH members to describe the practices in these health institutions. Twelve questionnaires were analysed. Ten institutions performed a posttransfusional alloantibodies research by issuing a prescription at the patient's exit with a return rate between 0.14 and 16%; 1 institution has a centralized organization with a return rate of 68.3%; 1566 red cell alloantibodies research were performed and among them, 24 alloantibodies appeared (1.53%)., Conclusion: These results indicate that to be effective, the management of this biological test must be centralized. Despite this, the red cell alloantibodies rate remains very low (0.9 and 1.53%) and raises the question of the relevance of this systematic testing after transfusion, which is in any case mandatory before a new transfusion of red blood cells., (Copyright © 2017 Elsevier Masson SAS. All rights reserved.)

Born in France in 1993, haemovigilance aims at monitoring the blood transfusion chain from the donor to the recipient, receiving labile blood products. It differs from the other vigilances due to its organization and its completeness dealing with the collected information. Prior to the European directive, the French agency created a new gravity level: grade 0, aiming at reporting and analyzing the blood transfusion chain dysfunction. Thus, haemovigilance gradually integrates the management of the risks and is given new missions in hospitals and private hospitals. One of its first actions will be to achieve an a-priori analysis, preventing the risks throughout the blood transfusion chain. Such crosscutting missions will be used to manage the coordination of vigilance and in some cases identity monitoring. Haemovigilance may be a key player in identity monitoring because patients' immunology-hematological data base can make it possible to confirm or deny a patient's identity (misused identity or homonyms). Haemovigilance is going to meet other challenges such as the training of health professionals', the implementation of patients' blood management and the periodic revision of the blood transfusions bulletin. A new crosscutting medical profession appears in some countries: blood transfusion practitioner. It combines vigilance, risk management, support for the therapeutic blood transfusions, health professionals training and the evaluation of practices and results. A final mission would be for haemovigilance to be responsible for medicinal products derived from human blood to allow a better monitoring of plasma transfusions., (Copyright © 2017 Elsevier Masson SAS. All rights reserved.)

Background: Blood products use has increased in France between 2000 and 2011. To understand the reasons for this increase, data about transfused patients and transfusion practices needed to be updated., Study Design and Methods: A nationwide cross-sectional survey was performed with health care establishments. Diagnoses and indication for the transfusion, pretransfusion laboratory results, and blood products used were collected during a randomly selected 24-hour period in 2011. All patients who received at least one blood product delivered on the survey day were included., Results: A total of 10,794 blood products were requested for 4720 patients: 8688 red blood cell (RBC) units, 842 platelet (PLT) concentrates, and 1264 fresh-frozen plasma (FFP) units. Hematologic and cancer pathologies included 46% of transfused patients, 34% of the patients had transfusions in a surgical context, and 32.4% of transfused patients were receiving medication with an impact on transfusion. Nearly half of RBC transfusions were performed with hemoglobin levels of less than 8 g/dL. PLT transfusions for prophylactic indication were prescribed with PLT counts of less than 20 × 10 9 and 50 × 10 9 /L in 56.9 and 86.6% of patients, respectively. RBCs and PLTs transfusion practices were in agreement with national guidelines. FFP units were involved in 8.0% of all prescriptions. Among these, 57.4% were requested in the context of an acute hemorrhage and 8.4% for plasma exchange. The median of FFP use (n = 2) in a nonsurgical context, excluding plasma exchange, suggests an insufficient dosing of FFP., Conclusion: Except for insufficient FFP dosing per patient and limitations on assessment of indications for prescribing, transfusion practices were in agreement with national guidelines., (© 2016 AABB.)

The act to transfuse is a prescription following basic rules similar to drug prescriptions. If harm happens, potentially linked with this prescription, the harm's responsibility is borne by the physician, the paramedics, the care organization but by the supplier laboratory too. The setting of good practice rules consistent with science data at the time when the act is performed, the respect of the patient's rights and the quality of supplied products will be assessed during the expertise. Under restorative responsibility, it is necessary to previously establish a direct and certain causation between the litigious act and the harm to enforce the vicarious liability. Nowadays, legal precedents grant a larger protection to more and more numerous victims, enhancing the field of the fault with the appeal to assumption of fault. At the same time, the lawmaker himself promulgated objective conditions of compensation for many categories of victims of medical risk from which transfused people are part. The law of March the 4th of 2002 went one step closer devoting a new foundation of compensation: national solidarity., (Copyright © 2014 Elsevier Masson SAS. All rights reserved.)

Blood transfusion is currently a delegated medical act in patient care services. Following severe adverse events, hemovigilance now disposes of a dense regulation. Data collection and analysis in the national hemovigilance "e-FIT" database allow detection of errors or malfunctions in the transfusion act. Blood transfusion safety depends on the strict respect of processes from the prescription of blood products and required patient immuno-hematology exams to the administration of blood products and follow-up of the patient. In the circular relative to the transfusion act, many steps of the transfusion process, less explicit, can be interpreted differently by health care professionals and thus lead to errors or severe adverse events. Standardization of procedures for the transfusion act and its surveillance would increase their safety and avoid potential risks for the patient., (Copyright © 2014 Elsevier Masson SAS. All rights reserved.)

The current issues debate will bring together experts around the themes of self-sufficiency (in its national and European aspects) and of needs in cellular blood products. The point of view of the manufacturer and prescribers of blood products will be confronted., (Copyright © 2013 Elsevier Masson SAS. All rights reserved.)

Introduction: Blood transfusion safety depends on strict compliance with each step of a process beginning with the order for labile blood products and related immunohematologic testing and ending with administration and follow-up of the receiver. This process is governed by stringent regulatory texts and guidelines. Despite precautions, processing errors are still reported. Analysis of incident reports shows that the most common cause involves patient identification and that most errors occur at two levels, i.e. the entry of patient information and management of multiple regulatory crosschecks and record-keeping using different systems., Method: The purpose of this report is to describe the collaborative approach implemented by the Établissement français du Sang Alpes-Méditerranée (EFSAM) and the Assistance publique des Hôpitaux de Marseille (APHM) to secure the blood transfusion process and protect interfaces while simplifying and facilitating exchanges., Results: Close cooperation has had a threefold impact with simplification of administration, improvement of experience feedback, and better management of test ordering. The organization implemented between the two institutions has minimized document redundancy and interfaces between immunohematologic testing and delivery. Collaboration based on experience feedback has improved the level of quality and cost control., Conclusion: In the domain of blood transfusion safety, the threshold of 10(-5) has been reached with regard to the risk of ABO errors in the distribution concentrated red cells (CRC). In addition, this collaborative organization has created further opportunity for improvement by deploying new methods to identify simplification measures and by controlling demand and usage., (Copyright © 2013 Elsevier Masson SAS. All rights reserved.)

Transfusions are exceptional while patients are rushed to hospital for sanitary reasons. The quality of care requires the collaboration with different partners (samu, blood bank centre, haemovigilance correspondents…). In response to dysfunctions that occurred during transports for sanitary reasons we have drawn up a regional procedure, which specifies how to get and use blood products. This procedure harmonizes our medical practice, states the role of the different participants (traceability of blood samples of immunohaematology tests, etc.), including a part dedicated to identity vigilance. The expected impacts of this procedure are: the decrease of dysfunctions and of destructions of red blood cells, the improvement of security while patients are transfused., (Copyright © 2012 Elsevier Masson SAS. All rights reserved.)

Although transfusion practices have changed these last years, the neonatal period remains one period when the transfusion of blood components (in particular in red blood cells concentrates) is frequent, particularly for low birth weight premature babies. It is thus important to know well the pathophysiological characteristics specific to this age of life in order to reduce the risks of transfusion and to allow an optimal effectiveness of this treatment. Various studies on neonatal transfusion show that transfusion practices during the neonatal period are very heterogeneous from a team to another, and even within the same team. Therefore, we wanted to know the practices in France, by addressing a questionnaire to neonatology centres, in collaboration with the French Society Vigilance and Transfusion Therapy and the French Society of Neonatology (SFN). The results obtained confirm the heterogeneity of practices. To follow up on this study, we constituted a working group, in partnership with the SFN, the SFVTT and the EFS, with an aim of proposing good practice recommendations according to the methodology of the French "High Authority for Health", in order to homogenize at the national level transfusion practices of the new-born baby., (Copyright © 2012. Published by Elsevier SAS.)

The French haemovigilance system designates a physician in charge of haemovigilance in each hospital. She/he collects the adverse reactions and events reported by medical staff or nurses. In 2010, 7360 (2.42/1000 units) adverse reactions and 518 adverse events (excepted donors) were reported. These results mean that the system is particularly effective in hospitals. This study collected the opinion of physicians in charge of haemovigilance about this organization., (Copyright © 2012 Elsevier Masson SAS. All rights reserved.)

The purpose of this retrospective observational multicenter study was to assess appropriateness of red blood cell (RBC) transfusion, according to the French national guidelines (Agence française de sécurité sanitaire des produits de santé) published in 2002. Six hundred and thirty-nine RBC transfusions from nine institutions have been randomly selected and analysed. The data collected are issued from different specialities. Patients' characteristics, occurrences of transfusion, admission, pre-transfusion, post-transfusion and discharge haemoglobin concentrations have been collected. Two physicians (who are in charge) must evaluate the appropriateness of pre-transfusion, discharged haemoglobin concentrations, quantity and quality of transfused RBC. The mean pre-transfusion haemoglobin concentration was 7.89 ± 1.24, the median number of transfused RBC was two (extremes: 1-16), the mean discharge haemoglobin concentration was 10.14 ± 1.30 (-5 days after the end of transfusion). The pre-transfusion and discharge haemoglobin concentrations were higher if the patient presented a co-morbidity factor. Ninety-three percent of pre-transfusion and 79% of discharge haemoglobin concentrations are in accordance with the guidelines. According to the physicians, the RBC transfusions are too "precocious" when pre-transfusion haemoglobin concentration is above nine and the anaemia is asymptomatic. 50% of RBC transfusion with discharge haemoglobin concentration above 10 is not excessive. In case of acute anaemia, the pre-transfusion and discharge haemoglobin concentrations are higher and RBC transfusion excessive. In this study, the trigger haemoglobin concentration is "restrictive", but the target haemoglobin concentration is "liberal" with a high-discharge haemoglobin concentration. Inappropriate RBC transfusions are mainly due to over-transfusion., (Copyright © 2010 Elsevier Masson SAS. All rights reserved.)

The Marseille public hospital system (APHM) has expressed its willingness to pool its services of immunohematology and delivery of labile blood products with those of the French blood institute Alps Mediterranean division (EFS AM). An agreement setting out the terms of this partnership was signed between the two parties. The users of the APHM and EFS AM blood watch wished to preserve the channels of distribution. Implementation of this reorganization has focused on ensuring transfusional safety, reinforcing harmonization of APHM practices, and finding ways to reduce costs. Despite joint information campaigns (to medical and paramedical personnel) carried out by the APHM and EFS AM blood watch, problems have arisen during start-up and adjustments have been necessary on both sides. The success of this project hinges on the involvement of the EFS AM in our transfusional practices, deployment of a system for diffusion of information, and consolidation of physical and human resources at the level of the APHM blood watch.

Analysing adverse events is part of the medical practice in so far as the part it plays is outstanding in terms of feedback and improved healthcare safety. The integrated implementation of this practice is based on a four-dimensional system: strategic (corporate policies), cultural (safety-oriented cultural mindset), structural (dedicated organization and resources) and technical (methodologies and utilities). Two case studies illustrate the sequencing process from selecting the to-be-analyzed event down to figuring out the appropriate action plan. Beyond the visible and obvious origin, thanks to the implemented methods such as causal tree or ALARM method, far-fetched analysis elements and identified factors likely to explain events can be discovered. Comments on the role and terms of feedback are also hereto expressed.

Incidents and accidents analysis is one part of risk management in healthcare organisations. It is based on methods such as healthcare process analysis and the Association of Litigation and Risk Management (ALARM) method, to understand not only immediate causes but also root causes. The goal is to implement relevant remedial and preventive actions to secure healthcare processes. The hospital's risk management unit has to be involved in the methodological analysis of every grade zero transfusion incident. The system is based on a retrospective analysis process in compliance with the French National Authority for Health's ongoing requirements for risk reactive approach, allowing to identify failures and start relevant actions. Healthcare teams should overcome difficulties in order to be totally involved in the process. Human factors recognition, establishment of clear and effective communication between individuals and critical points of control should provide optimum quality care services that are safe and free of unnecessary risks.

The hospital risk management department is firstly involved in the methodological analysis of grade zero transfusion incidents. The system is based on a subsequent analysis process in compliance with the ongoing requirements of the Haute Autorité de santé (HAS) for a reactive approach to risk, allowing to identify failures and start the appropriate preventive and corrective measures. The use of the association of litigation and risk management method makes easier the grade zero analysis and brings to light the team or institutional, organizational, temporal, individual factors representative of undesirable effects. Two main factors come out again from this analysis, the absence of the identification bracelet coupled with a disrespect of transfusion procedures in force. The whole institution must be concerned by these improvement actions. Health teams should overcome difficulties to be totally involved in such a process. Human factors' recognition, establishment of clear and effective communication between individuals and information sharing should provide optimum quality care services which are safe and free of unnecessary risks.

From 2005, PACA area has formed think-tank group a priori risk in the transfusional chain. It has enabled to determine each step of the elementary process and evaluate the frequency, the seriousness and critical effect of the errors. Blood sample and conformity are the most critical points and depend on the vigilance identity. In September 2007, the southern blood bank of France has settled 12 nonconformities levels of blood samples. They send the listing of the nonconformities every month. This listing enables the executive staff to determine the errors and, therefore, to solve them. The regional notification of 2007 to 2008 confirms analysis of the think-tank team. Hence, we were able to list the most serious cases. Public and private hospitals have to notify the serious events and will be bound to evaluate professional practices. These acts will be taken into account by the regional-medical contract.

Blood transfusion is a medical act, which follows the dictates of important rules in medical responsability. The following presentation will mention the legal responsibility of the practitioner throughout the transfusion process: first, giving the patient complete and precise information and geting his full consent; then, writing the appropriate prescription; finally, balancing the benefice and risk of therapy and using reglementation to avoid the practitioner's responsibility to be put at risks.

Unlabelled: This multi-centre study aimed to assess the knowledge in blood transfusion of medical staff in 14 state-run hospitals., Materials and Methods: A questionnaire was distributed to all potential prescribers of blood products. It contained 35 questions concerning various subjects: blood products, immuno-haematology, prescription of blood products, transfusion practice, interpretation of the final bedside controls. The rate of correct answers (RCA) was obtained for each question, for each subject, and for nine questions defined as essential for patient safety. A weighted score was also calculated by ranking each question between one and six according to its importance., Results: Six hundred and ninety four questionnaires were analysed (rate of return 15%). The RCA ranged from 14 to 89%, according to the questions. The RCA ranged from 47 to 78% for seven of the nine essential safety questions, and 82% and 83% for the two questions concerning the interpretation of incompatible final bedside controls: there were 9% of wrong answers, which validated an incompatible blood transfusion. The mean weighted score was 62%. Both the RCA and the weighted score were higher for those that regularly prescribe blood products than for that only prescribe them occasionally. There were no significant differences between hospitals., Conclusion: This study has confirmed that medical staff have deficiencies in their knowledge of blood transfusion, deficiencies which are acknowledged by medical staff. These first results will help the members of the study group to develop and prioritize various actions to improve this state of affairs, and to follow the effects of the training given.