Unacknowledged adverse transfusion reactions: Are they a mine to dig?

OBJECTIVES: Haemovigilance has long tried to characterize and understand transfusion reactions in order to prevent them. Unacknowledged ones are now a minority but they question us. Are they the result of incomplete clinical setting and/or insufficient medical reasoning, or can they contain real new entities we have not yet understood? MATERIAL AND METHODS: Ten volunteer experts reviewed 30 recent unacknowledged cases. Their diagnostic propositions were compared with data issued from a five-year repository we have analysed in terms of statistical links between clinical signs and diagnoses. RESULTS: Experts' opinions are only quite unanimous in 60% of the cases, and the proposed diagnosis remains unacknowledged in 53%. Repository comparison shows that signs like pain or digestive symptoms are far more frequent in unknown reactions. However, it is more the absence of some other signs which drives to that conclusion, in a default diagnosis mechanism. CONCLUSION: Errors in transfusion reactions medical analysis are rare. Unacknowledged cases are more often linked to poor or unspecific clinical setting. But a particular attention must be paid with infrequent diagnoses which are far less characterised, like metabolic complications. Pain high occurrence in unknown cases also commands us to go further in the characterisation of acute pain transfusion reaction diagnosis, which is suggested by some authors.

[Delayed adverse reactions to blood donation: From haemovigilance data to specific studies]. / Les effets indésirables retardés chez les donneurs de sang : des données de l'hémovigilance aux études spécifiques.

OBJECTIVES: Delayed adverse reactions to blood donation occur after the donor left donation site. Their intrinsic gravity and possible complications can be increased by the fact the donor is alone. This can also increase bad memories, leading to a donation giving up. Blood transfusion centre is only aware in case of donor feedback, hence an event underrating. We choose to compare our data upon delayed adverse donor reactions with those we could find in past studies. METHODS: A first data level comes from French haemovigilance data while serious adverse reactions declaration is mandatory. But a second level can be reached using blood transfusion centre computerized data because all the donation reactions are saved whatever the gravity is. In both cases, delayed reactions are only those reported by donors. We try to make an exhaustive search of specific studies upon the real delayed reactions incidence so as to compare with our data. RESULTS: There were 1957 serious adverse reactions declared in our regional haemovigilance database between 2011 and 2015: 49 % occurring during donation, 40 % after it but before donor departure, and 11 % delayed events. There were 16,050 adverse reactions recorded during the first trimester of 2016 in mainland France, with 2.7 % delayed ones. Proportion of delayed events rises when gravity rises, until 27.6 % for the most serious ones. It varies between 2.2 % and 2.7 % for vasovagal reactions, haematomas, and other local reactions, and reaches 16.2 % for other general reactions. Data found in other studies with a spontaneous donor notification are of the same kind. But four studies soliciting specifically donor notification give a dramatically higher delayed reactions incidence, with an understatement greater than three out of four. Moreover, these studies found a majority of delayed reactions, which are not included in haemovigilance like fatigue or bruising. CONCLUSIONS: Occurrence of a delayed donor reaction is clearly underrated in standard haemovigilance. It remains to be seen whether it have the same impact on donor return as immediate reactions. Considering that delayed reactions are much larger, it might be interesting to take them into account in the evaluation of strategies dedicated to lower immediate reactions.

EFS Centre-Atlantique donor's biobank: Ten years of samples usage.

INTRODUCTION: The French Establishment of Blood Centre Atlantique (EFSCA) is one of the French regional blood transfusion centers. Donor's biobank is a mandatory activity leading to the storage of biological samples taken from the blood donor. Samples of each blood donation are preserved for a 5-year period at Châteauroux in the form of two straws of 500microliters stored in liquid nitrogen. The aim of this study was to analyze the samples usage by studying quantitative, qualitative and economic criteria. MATERIAL AND METHOD: We analyzed all the requests of stored blood samples from 2005 to 2014. They were coming either from the blood donor qualification laboratory (BDQL), in order to perform complementary tests, or from hemovigilance inquiry. RESULTS: Among the blood donation samples, 2,144,636 (whole blood, plasma or platelets apheresis) were preserved during these ten years. During this period, 548 (0.025%) requests for samples were received; 78% were in relation with a request of the BDQL and 22% in relation with a request of hemovigilance. For the straws, the mean exit delay with regard to the blood donation date was 11.5 months (2-55). The cost of samples exit includes only working hours of a laboratory technician. On average, the annual working time dedicated to this activity was 23h. Also, the average price for one-year issuing activity was 620.31 euros. CONCLUSION: In our study, the donor's biobank was little used. The part of hemovigilance was weak but essential for the blood safety.

[North-South cooperation on transfusion and hematology teaching: A Benin experience]. / Coopération Nord-Sud pour le renforcement des capacités du personnel de santé en hématologie et transfusion : expérience du Bénin.

Hematologic diseases are a significant part of health disorders in Benin. As an example, anemia is the second cause of hospitalization, measuring up to 7.9% all over the country (National Plan of Sanitary Development, 2009-2018). By contrast, there is only one active hematologist in the country. Thanks to two partnerships, on one hand between the health sciences faculty in Cotonou (Benin) and the medicine one in Tours (France), and on the other hand between the Beninese Blood Transfusion National Agency and the French Blood Establishment, a first blood transfusion and hematology formation was held in Cotonou on December 2014. Among other benefits, was created an hematology-transfusion network in order to facilitate relations between Beninese hospital doctors, with the support of the two French partner institutions. The article describes this progress.

Blood donors--Serious adverse reactions (SAR) 2010-2014 EFS Châteauroux, France.

BACKGROUND: In 2013, the national French incidence of serious adverse reactions (SAR) was 155.7 per 100,000 donations and 82% of SAR were grade 2 (French classification of SAR related to blood donors) AIMS: The purpose of our study was to describe the profile of blood donator candidate which had a SAR in our center. METHODS: The study contains all the SAR superior to grade 1 occurred on the site EFS Châteauroux (site and mobile blood collection) from January 2010 to October 31, 2014. We analyzed 37 parameters from the e-fit files (e-site French blood vigilance) and In-log software. RESULTS: We identified 82 SAR for 72,553 blood donations (incidence: 113.02 SAR per 100,000 donations). Forty-one men and 41 women, middle age 39 years (18-66). Average height: 1.68 m (1.49-1.85); average weight: 68 kg (50-98); body mass index (kg/m(2)): 24,13(18.6-31.9). All donors were Caucasian and 30% unemployed. We found 74 vasovagal syncope (VVS), 5 hematomas, 2 arterial injuries and an adverse reaction to citrate. In 90%, the SAR was immediate and of grade 2 in 85% of cases. Thirty-seven percent of SAR were first donation in connection with whole blood in 87% of cases. Regarding the seniority of donors, the number of average donations (whole blood, plasma, platelets) was 16.5. An SAR determined the stop of blood donation in 65% of cases with nearly 80% stoppage if it was a first donation. Seventy-three percent of SAR as a VVS took place during blood collection or within 5 minutes following the end of the donation. Sixty-one percent were men. Forty-four percent of cases were a first donation and 83% occurred in mobile blood collection. Average age was 36 years. The result was a permanent stop of all type of donations in 76% of cases. Twenty-seven percent of SAR as a VVS took place beyond 5 minutes after the end of the donation. Seventy-five percent were women. Thirty percent of cases were a first donation and 95% of SAR occurred in mobile blood collection. Average age was 42 years. The result was a permanent stop of all type of donations in 40% of cases. CONCLUSIONS: When the SAR as a VVS occurs during or within 5 minutes following the end of the donation, it leads to a permanent stop of any type of donation in 76% of cases.

Patient labels as a quality indicator of identitovigilance in French hospitals.

INTRODUCTION: Identity risk is frequent and serious. Between 2007 and 2010, 25.6% of 1572 serious adverse events declared in France are related to identitovigilance. No regulation clearly defines an ideal patient label even when a delivery refusal is applied in case of absent or incomplete identity (absence of surname and/or first name and/or birth date). The aim of the study was to draw up the current situation of patient labels in hospitals connected with our blood transfusion center and being used for blood products delivery and immuno-hematology analyses. MATERIALS AND METHODS: We defined an ideal label with 5 items which must be present and clearly identified: surname, usual or marital name, first name, birth date and sex. It contains also an identifier, if possible with a bar code. We compare it with labels used in our hospitals. RESULTS: Only 22% (17/76) had a patient label in compliance with our ideal label. Most of the items, even if they were not clearly identified on the label, were present. The surname was present and clearly indicated in 75% of cases (57/76). In approximately 50% of cases, there was a barcoded permanent and/or stay identifier. CONCLUSION: Our results, with only 22% of labels considered as 'ideal', show all the work which remains to be done. A temporary solution can be the elaboration by hospitals of an identification guide of their present labels.

[Postdonation information: the French fourth hemovigilance sub-process]. / L'information post-don, le quatrième sous-processus de l'hémovigilance.

Postdonation information is the knowledge of information about the donor or his donation, occurring after it, which challenges quality or safety of the blood products stemming from this or other donations. Classical hemovigilance sub-processes concerning donors or recipients adverse events do not cover this topic. France is just about to make it official as a fourth sub-process. Less formal management of postdonation information is already set up for more than ten years. French data of the year 2013 are presented, including the regional notification level and the national reporting one. A significant level of heterogeneity is observed as for other hemovigilance sub-processes. It is mainly due to subjective rather than objective differences in risk appreciation. A real consensual work is expected about it in the future.

[Evaluation of blood grouping in ABO and Rh systems in health facilities in Benin]. / Évaluation du groupage sanguin dans les systèmes ABO et Rh dans les formations sanitaires du Bénin.

STUDY PURPOSE: The goal of this work is to assess the modalities of blood typing achievement in Benin with the view of their improvement. METHODS: On the basis of a questionnaire including the detailed operative process, a prospective investigation has been achieved in public and private health centers laboratories. RESULTS: It came out that the execution of ABO and Rh blood typing took place globally on the fringe of the standards. We note that 72.4% of the private laboratories and 48.9% of the public ones lacked at least one equipment and 51.3% at least one material for blood withdrawal; 38.2% of the laboratories did not respect blood withdrawal standards; 1.32% of the laboratories applied the 4×2 rule. The assessment revealed that respectively 10.8% and 30.7% of the blood centers and non-blood centers achieved the globular test solely; the same 40.5% and 46.2% used reagents of different brands. Anti-A1 and anti-H sera, and A1 and A2 red cells were not available in any laboratory. More than 64% of laboratories have senior technicians and biomedical analysis engineers but only 6.6% of the laboratories were directed by biologists, and 9.2% of the laboratories function with only one technician. CONCLUSION: Instead of some assets, the laboratories assessment noted important non-conformities we ought to raise as a matter of urgency. It is a challenge whose resolution must give blood transfusion centers a reference position relatively to blood grouping when facing blood typing difficulties.

[Reality and importance of transfusion-transmitted malaria in a stable endemic context: Cotonou case in Benin]. / Réalité et importance du paludisme transfusionnel dans un contexte d'endémie stable : cas de Cotonou (Bénin).

Malaria endemic status of our countries supports avoiding malaria screening for the blood qualification. But this attitude makes young children, pregnant women and people without semi-immunity incur a high risk of malaria. The goal of the survey was to value the reality and the importance of transfusion-transmitted malaria and to assess its determining factors. The study included 141 packed-red-cells units transfused to 77 hospitalized recipients, not suffering from malaria and not having been transfused the last two weeks. Every packed-red-cells assigned to a patient was tested for malaria before use. Thick and thin blood film were performed 96hours after transfusion. A clinical follow-up was undertaken as well as in the hospital and at home after release. In all, 13.47% of the transfused packed-red-cells were positive for the thick blood film. Plasmodium research in patients was negative 96hours after transfusion, even in the 19 patients who had received parasitized blood units! The home follow-up had permitted to note that 15.78% of blood recipients had developed clinical malaria. Parasitic density ≥240 parasites/mm(3) seems to be a determining factor. Transfusion-transmitted malaria is a reality we ought to consider. Introduction of malaria screening in donated blood qualification testings simultaneously with a framing of the blood donors appear the lasting solution to hope in the future to limit the waited excessive blood evictions.

[Data processing and blood transfusion activities: fact and future in 2013]. / La place de l'informatique dans l'activité transfusionnelle et son évolution--Panorama 2013.

It is now hard to think of blood transfusion activities without data processing. Blood transfusion centers are unable to work without it since a long time. Its necessity in hospital blood banks is following the same pattern. Electronic data interchange between them is growing because of their high interdependence. A lot has already been done and works routinely. But a lot remains to be done, due to continuous evolution of computer science and blood transfusion itself.

[Computerization of hospital blood banks in France]. / Informatisation des dépôts de produits sanguins labiles en France.

In France, most blood products are delivered by the établissement francais du sang, directly to the recipients, and hospital blood banks deliver a minor part, but are independent from it. However that may be, hospital blood banks are hazardous activities regarding to recipients, blood products, blood supply of the hospital and regional blood supply. Because of the high risk level, a computerized information system is compulsory for all hospital blood banks, except for those only devoted to vital emergency transfusion. On the field, the integration of computerization in the different processes is very heterogeneous. So, it has been decided to publish guidelines for computerizing hospital blood banks information systems and production management. They have been built according to risk assessment and are intended to minimize those risks. The principle is that all acquisition and processing of data about recipients or blood products and tracking, must be fully computerized and that the result of all manual processes must be checked by computer before proceeding to the next step. The guidelines list the different processes and, for each of them, the functions the software must play. All together, they form the basic level all hospital blood banks should reach. Optional functions are listed. Moreover, the guidelines are also aimed to be a common tool for regional health authorities who supervise hospital blood banks.

[Computerization of hospital blood banks in France: what has been done and what remains to be done]. / Informatisation des dépôts de sang: ce qui est fait et ce qui reste à faire.

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.

[Factsheets: support in the analysis of recipients' adverse reactions]. / Fiches techniques: aide à l'analyse des effets indésirables receveurs.

In order to help the analysis of adverse effects of transfusion, factsheets have been written by working groups of the French agency for the safety of health products ANSM. Each factsheet deals with a blood transfusion side effect and is composed of five parts, including pathophysiological mechanisms, diagnostic criteria, management recommendations, etiologic investigations and rules for filing the notification form to ANSM. Since 2006, 11 factsheets have been published on the French haemovigilance network website. The major characteristics of the two last sheets published "post-transfusion purpura" and "non erythrocyte incompatibility reaction" are presented, followed by the updated card for "allergy". These factsheets give relevant guidelines allowing better evaluation of recipients' adverse reactions, particularly their diagnosis, severity and accountability. They also could initiate studies among European and international haemovigilance networks.

Hypersensitivity reactions to blood components: document issued by the allergy committee of the French medicines and healthcare products regulatory agency.

These guidelines represent a consensus among experts on hypersensitivity reactions occurring after transfusion of blood components. They cover recognition, investigation, treatment, and prevention of such reactions. Implemented in France under the auspices of the French Medicines and Healthcare Products Regulatory Agency (AFSSAPS) and based on current knowledge, research, and experience, they aim to provide effective and easily teachable means of further improving the quality of hemovigilance databases, promote interest in this field, and help identify possible mechanisms and at-risk patient groups.

[Computerization of hospital blood banks in France]. / Informatisation des dépôts de produits sanguins labiles en France.

In France, most blood products are delivered by the Établissement français du sang, directly to the recipients, and hospital blood banks deliver a minor part, but are independent from it. However that may be, hospital blood banks are hazardous activities regarding recipients, blood products, blood supply for the hospital and regional blood supply. Because of the high risk level, a computerized information system is compulsory for all hospital blood banks, except for those only devoted to vital emergency transfusion. On the field, integration of computerization in the different processes is very heterogeneous. So it has been decided to publish guidelines for computerizing hospital blood banks information systems and production management. They have been built according to risk assessment and are intended to minimize those risks. The principle is that all acquisition and processing of data about recipients or blood products and tracking, must be fully computerized and that the result of all manual processes must be checked by computer before proceeding to the next step. The guidelines list the different processes and, for each of them, the functions the software must play. All together, they form the basic level all hospital blood banks should reach. Optional functions are listed. Moreover, the guidelines are also aimed at being a common tool for regional health authorities who supervise hospital blood banks.

[Immunological blood transfusion safety and selection of red blood cells issued from hospital blood banks]. / Choix des concentrés érythrocytaires délivrés par les dépôts et sécurité transfusionnelle immunologique.

Allogeneic red blood cells transfusion is always an immunological challenge and the choice of the blood products is crucial for the patient safety. But this choice may be hampered by the quality or the quantity of the available supply. In the end, the lack of transfusion may be more harmful than transfusion. The balance between patients' needs and blood centres supplying is always delicate. The conditions are not the same for all blood groups. Things are easier for the KEL1 phenotype, where the supply must ensure only 92.5% of KEL: -1 red blood cells instead of the 91% expected. More complicated is the situation for group O red blood cells with 47 versus 43%. But the major problem concerns RH: -1 red blood cells, for which the needs reach 20.1 versus 15%. These challenges require a lot of efforts from blood centres staffs to influence blood donors' recruitment and appointments. A justified and carefully selected blood products issuing may be of great help, especially for group O RH: -1 red blood cells. Therefore, hospital blood banks must have ad hoc procedures and a trained staff to put them into practice.

[Hypotension and adverse transfusion reactions: from the associated clinical signs to the hypotensive transfusion reaction]. / L'hypotension artérielle dans les effets indésirables receveurs: du signe clinique associé à la réaction transfusionnelle hypotensive.

OBJECTIVE: The first aim of this study was to confirm the presence of hypotension blood transfusion reactions and to assess the part of hypotension as a principal event, as defined by the literature but not characterized in French haemovigilance data. As well, recent series of several cases led us to consider a possible incidence increase. STUDY DESIGN: Using a retrospective observation, the haemovigilance data from 2000 to the end of 2007 of two French regions were reviewed. During this period, 1159657 blood units were transfused by nearly 100 hospitals and 3727 adverse reactions observed. RESULTS: One hundred and sixty-eight adverse reactions with hypotension were noticed and analyzed, representing 4.5% of all transfusion reactions and revealing an incidence of 14.5 for 100000 blood units transfused. It turned out to be mostly male recipients, severe reactions and appearing rather in the beginning of transfusions. Although platelets having greater incidence, all types of blood products may be involved. The clinical diagnosis was the following: 40 to 47% were classified as febrile reactions, 13 to 17% were allergic reactions, 8 to 9% were due to immunologic and/or haemolytic reactions, 5 to 7% resulted of cardiologic disorders, 5% resulted of hypovolemic contexts and 22% were unexplained hypotensive transfusion reactions. CONCLUSION: In about three cases out of four, transfusion-induced hypotension was associated with other clinical reactions. Indeed, hypotensive transfusion reactions were identified, having an incidence of 3.2 for 100000 blood units transfused. Furthermore, there was no explanation found for the incidence increase in our region during 2007. A national study was suggested to analyse the national data as well as a prospective study to clear out this type of transfusion reactions.