RESUMEN
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.
Asunto(s)
Seguridad de la Sangre/tendencias , Bancos de Sangre/organización & administración , Bancos de Sangre/normas , Predicción , Francia , Humanos , Sistemas de Identificación de Pacientes , Prescripciones/normas , Garantía de la Calidad de Atención de Salud/organización & administración , Gestión de Riesgos/organización & administración , Medicina Transfusional/educaciónRESUMEN
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.
Asunto(s)
Bancos de Sangre/legislación & jurisprudencia , Seguridad de la Sangre , Transfusión Sanguínea/legislación & jurisprudencia , Garantía de la Calidad de Atención de Salud/legislación & jurisprudencia , Bancos de Sangre/normas , Tipificación y Pruebas Cruzadas Sanguíneas , Seguridad de la Sangre/normas , Transfusión Sanguínea/normas , Recolección de Datos , Bases de Datos Factuales , Francia , Personal de Salud , Humanos , Selección de Paciente , Vigilancia de la Población , Prescripciones/normas , Gestión de Riesgos , Reacción a la TransfusiónRESUMEN
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.
Asunto(s)
Seguridad de la Sangre , Conducta Cooperativa , Instituciones de Salud/normas , Seguridad del Paciente , Comité de Profesionales/organización & administración , Gestión de Riesgos/organización & administración , Certificación/normas , Contención de Riesgos Biológicos , Seguridad de Equipos , Francia , Humanos , Política Organizacional , Sistemas de Identificación de Pacientes , Seguridad del Paciente/normas , Farmacovigilancia , Administración de la Seguridad , Sociedades MédicasRESUMEN
French regulation requires hospital blood banks to have data processing of their blood transfusion activities. In order to help them to achieve this goal, guidelines were published by an official working party. For their diffusion, a study was launched to assess current gaps between guidelines and reality. Analysis of the first forty responses shows: 1) computerization is already set up for main blood banks and is going well for the others; 2) most of guideline functionalities are now working in main blood banks; but some points need specific developments; 3) taken as a whole, other blood banks are further from guideline requirements, even if some have already reached the goal; 4) guidelines are able to point out to all hospital blood banks what remains to be done.
Asunto(s)
Bancos de Sangre , Sistemas de Computación , Hospitales , Francia , HumanosRESUMEN
In the Poitou-Charentes area, a regional pilot program was implemented over a two year-period to improve transfusion safety in public and private hospitals. This program consisted in: (i) an evaluation of the transfusion chain in hospitals; (ii) a regional program to guide hospitals in improving the quality process. Five workgroups were set up. Three persons in each hospital should participate in the workgroup: one representing the administration, one the medical staff and one the nursing staff. After a six months follow-up several hospitals were prompted to implement corrective and preventive measures to improve transfusion safety; (iii) a letter was regularly published to contribute to set-up a regional haemovigilance network. Such a quality improvement program revealed to be a relevant method to steer the changing blood transfusion process in hospitals.
Asunto(s)
Transfusión Sanguínea/normas , Recolección de Muestras de Sangre/normas , Francia , Hospitales Privados/normas , Hospitales Públicos/normas , Humanos , Garantía de la Calidad de Atención de Salud , Control de Calidad , Regionalización/normas , SeguridadRESUMEN
OBJECTIVES: Evaluation (usefulness and safety) of programmed autologous transfusion in obstetrics. SITE. Blood Transfusion Centre, Hôpital Louis-Mourier, F 92700 Colombes. PATIENTS: Prospective study of 150 patients for whom blood withdrawal was planned during the last month of pregnancy. Entry criteria were either a risk of haemorrhage or persistent patient request. PROTOCOL: Two withdrawals were planned during the last month of pregnancy at the out-patient clinic at a one-week interval. The autologous units were transfused per-partum in case of haemorrhage and/or post-partum in case of anaemia. RESULTS: One hundred pregnant women entered the protocol (43 had a risk of haemorrhage). Both preplanned withdrawals were made in 60 of these patients. Per-partum transfusions were necessary in only 7 patients including 4/43 with a risk factor (9%) and 3/57 with no risk factor (5%). Post-partum transfusions were made in 22 other patients. Consequently, 117 of the 160 units collected were not used (73%). CONCLUSION: Despite good tolerance (5% incidence) due to the known problems in evaluating the risk of haemorrhage and the small percentage of patients without risk factors who were transfused per-partum, we have decided to reserve this protocol for patients with an authentically identified risk of haemorrhage (placenta praevia, cesarean section, uterine scar tissue).