[Certification of health establishments: the changing perspective on transfusion risk]. / Certification des établissements de santé pour la qualité des soins : le regard évolue sur le risque transfusionnel en ES.

The HAS certification for healthcare organisation has gradually introduced the concepts of risk and relevance of care. Related to quality and safety of care, the transfusion act has early been part of the referential, and it seemed interesting to us to observe the changes in the requirements on this topic. After taking into account the regulations and the organization of haemovigilance in the establishment, it is now the search for the factual result for the patient which is the objective of the two main criteria devoted to transfusion. At the same time as the referential, the investigation methods have also evolved: the targeted tracer for Labile Blood Products and Blood-Derived Medicines allows a more detailed analysis geared towards the effective implementation of good transfusion practices. In conclusion, certification has moved from organizing and auditing the process to directly measuring transfusion safety for the patient.

[Recommendations and management in Home Blood Transfusion: Levers, brakes and prospects]. / Recommandations et prise en charge transfusionnelle en HAD : leviers, freins et perspectives.

In our roles as regional coordinator for haemovigilance and transfusion safety (RCHTS - CRHST), Correspondant for haemovigilance in a medical and surgical obstetrics/hospital home care centre (MSO/HHCC-MCO/HAD) and a doctor responsible for haemovigilance in HHC, we shared our interdisciplinary viewpoints and compared our practices in an attempt to gain a better understanding of the factors that hinder and facilitate the development of blood transfusion in HHC. Despite the revaluation of tariffs for blood transfusion in HHC (effective since March 2018), and the widespread circulation of recommendations for good practice in the transfusion of packed red blood cells in HHC (April 2018), this sector is still struggling to develop. On completing our analysis, we were able to demonstrate that while our institutional and regional work continues to be essential, the power to move things forward now lies in the hands of a national authority. In our opinion, using this power would give strong, national recognition of the vital role which HHC played at a nationwide level throughout the recent health crisis.

Concerning one case of rupture of a flow regulator: How patient safety procedures contribute to the correct use of medical devices.

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.

[Intravenous lines in transfusion and their medical devices]. / Les voies d'abord transfusionnelles et leurs dispositifs médicaux.

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.

[Analysis of causes of destruction of labile blood products in health institutions: A multicentric study]. / Analyse des causes de destruction des produits sanguins labiles dans les établissements de santé : une étude multicentrique.

OBJECTIVE: One of the tasks of haemovigilance correspondents in Health Institutions (HI) is to reduce the destruction of labile blood components (LBC). The objective of this study was to analyse in depth, five years after a first multicentric study, the causes of LBC destruction in order to assess the impact of measures taken and to define new ways of improvement. METHODS: Prospective analysis was carried out throughout 2016. For every LBC destroyed, the following elements were reported: type of LBC, transfusion department, cause of destruction analysed according to a decision tree, subsequently classed as avoidable or unavoidable. RESULTS: The study included 15 HI. A total 3058 LBC were destroyed, representing an average 0.90% of issued LBC, and this analysis concerned 2576 LBC. Sixty-seven percent of LBC were issued for surgery, intensive care or emergencies. Forty percent of the causes of destruction were patient-related (death, clinical worsening, adverse effects or abnormal constants prior to delivery). Thirty percent were prescription-related, mainly cases of excessive prescription for different reasons. Eleven percent were linked to organisational issues. The rate of destruction judged avoidable, all causes combined, was 36%. CONCLUSION: Comparison with the precedent study shows improvement, thus revealing the efficacy of implemented measures (single-dose distribution, return procedures back to the site of distribution, training of participants). In order to further reduce this rate of destruction, we suggest to promote storage procedures and, above all, to continue to raise awareness within healthcare teams.

[Is the research of posttransfusional alloantibodies still relevant?] / Est-ce que la réalisation de la recherche d'anticorps antiérythrocytaires post­transfusionnelle est toujours pertinente ?

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.

[French haemovigilance from 1994 to nowadays: Evolution and prospects]. / L'hémovigilance française de 1994 à nos jours : évolution et perspectives.

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.

Unreliable patient identification warrants ABO typing at admission to check existing records before transfusion.

BACKGROUND AND OBJECTIVES: This study describes patient identification errors leading to transfusional near-misses in blood issued by the Alps Mediterranean French Blood Establishment (EFSAM) to Marseille Public Hospitals (APHM) over an 18-month period. The EFSAM consolidates 14 blood banks in southeast France. It supplies 149 hospitals and maintains a centralized database on ABO types used at all area hospitals. As an added precaution against incompatible transfusion, the APHM requires ABO testing at each admission regardless of whether the patient has an ABO record. The study goal was to determine if admission testing was warranted. MATERIALS AND METHODS: Discrepancies between ABO type determined by admission testing and records in the centralized database were investigated. The root cause for each discrepancy was classified as specimen collection or patient admission error. Causes of patient admission events were further subclassified as namesake (name similarity) or impersonation (identity fraud). RESULTS: The incidence of ABO discrepancies was 1:2334 including a 1:3329 incidence of patient admission events. Impersonation was the main cause of identity events accounting for 90.3% of cases. The APHM's ABO control policy prevented 19 incompatible transfusions. In relation to the 48,593 packed red cell units transfused, this would have corresponded to a risk of 1:2526. CONCLUSION: Collecting and storing ABO typing results in a centralized database is an essential public health tool. It allows crosschecking of current test results with past records and avoids redundant testing. However, as patient identification remains unreliable, ABO typing at each admission is still warranted to prevent transfusion errors.

[Responsibility for prescribing and monitoring an act transfusion and safety blood transfusion]. / La responsabilité en matière de prescription et surveillance d'un acte transfusionnel et sécurité des produits sanguins.

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.

[Evaluation of transfusion hemochromatosis prevalence, SFVTT-01 study: preliminary results of the SFVTT working group]. / Évaluation de la prévalence de l'hémosidérose post-transfusionnelle, étude SFVTT-01: résultats préliminaires du groupe de travail de la SFVTT.

RATIONAL: Although notification of post-transfusion hemosiderosis is mandatory since 1994 among the French hemovigilance network, it is so far largely under reported. PATIENTS AND METHODS: We screened 42,443 patients hospitalized for blood diseases in France in 2009 and 2010 and determined which patients had received more than 20 PRC. Among them, we selected those having at least one measure of serum ferritin, and subsequently those which ferritin was greater than or equal to 1000 ng/mL. RESULTS: Three thousand eight hundred and twelve patients (9%) received more than 20 PRC, 1935 (4.5%) had a ferritin assay, which was increased in 1216 patients (2.9%). Eight hundred and eighty-one patients underwent an hemovigilance report form. Forty-nine percent had low-risk myelodysplasia or acute leukemia, 7% hemoglobinopathies. Hemosiderosis was asymptomatic for 680 patients (77%), serious 188 (88%) and life-threatening for 11 (1%). Two patients died of terminal heart failure. The most severe hemosiderosis (≥ grade 2) were low-risk myelodysplasia and idiopathic aplastic anemia. Ninety-two percent of thalassemia patients and 46% of sickle cell anemia patients received an iron chelator. For low-risk myelodysplastic syndromes and idiopathic aplastic anemia, 228 of the 317 patients whose treatment is known and who could benefit from iron chelation (72%) have not received it. CONCLUSION: These results encourage seeking optimal transmission of information (over 20 CGR) to the clinician, and prolonging hemovigilance action towards a more comprehensive statement of post-transfusion hemochromatosis.

[Why is it necessary to review the December 15th 2003 circular relative to the transfusion act?]. / Pourquoi réviser la circulaire du 15 Décembre 2003, relative à l'acte transfusionnel?

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.

[Documents and transfusion acts: heterogeneous practices]. / Documents et acte transfusionnel: hétérogénéité des pratiques.

Blood transfusion is currently a delegated medical act in patient care services. 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. We conducted a survey among haemovigilance correspondents to establish the documents needed to practice blood transfusion. Blood products delivery depends on the hospitals local organizations and blood products traceability relies on hospitals levels of computerization. We notice heterogeneous practices. Consequently, an updating of the December 15th 2003 circular relative to the transfusion act seems necessary and could thus lead to blood transfusions homogenous practices.

[Roundtables of SFTS Congress 2013: Needs, indications and safety of blood products; self-sufficiency in blood products]. / Besoins, prescriptions et sécurité des produits sanguins labiles ; autosuffisance en produits sanguins labiles.

The current issues debate brings 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 are confronted.

[Interest of a collaboration between the vigilances' coordination and care-related risks management committees in a health care center]. / Intérêt d'une collaboration entre la coordination des vigilances et la gestion des risques liés aux soins dans un établissement de santé.

Health care vigilance committees appeared with time in France. Some vigilance entities are present at a regional level, but all are found at the National Drugs and Health Care Products Safety Agency. Along with health care centers' certification, vigilance committees' coordination has evolved: whereas its presence was optional in the first version of certification, it has now imposed itself within health care centers with the more recent versions of certification, detailing the actions it must undertake. In parallel, a lot of attention is put on health care-related risk management with a health care center. Vigilances' coordination can thus take advantage of this in sharing an incident declaration system common with that of health care-related risks management. This collaboration will enable the generation of a priori risks' maps, help analyze adverse events and use the notion of criticality within a global safe care policy in each health care facility.

[Self-sufficiency, needs, prescription and safety of blood products]. / Autosuffisance, besoins, prescription et sécurité des produits sanguins labiles.

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.

[Organization of safe cost-effective blood transfusion: experience APHM-EFSAM]. / Pour une organisation transfusionnelle sécuritaire aux risques et coûts maîtrisés : l'expérience APHM-EFSAM.

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.

[National survey of transfusion practices in the neonatal period for the development of recommendations based on the "Haute Autorité de Santé methodology"]. / Enquête nationale sur les pratiques transfusionnelles pendant la période néonatale en vue de l'élaboration de recommandations selon la méthodologie de la Haute Autorité de santé.

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.