Patient blood management knowledge and practice among clinicians from seven European university hospitals: a multicentre survey.

BACKGROUND AND OBJECTIVES: The aim of this survey was to evaluate the knowledge about Patient Blood Management (PBM) principles and practices amongst clinicians working in seven European hospitals participating in a European Blood Alliance (EBA) project. MATERIALS AND METHODS: A web-based questionnaire was sent to 4952 clinicians working in medical, surgery and anaesthesiology disciplines. The responses were analysed, and the overall results as well as a comparison between hospitals are presented. RESULTS: A total of 788 responses (16%) were obtained. About 24% of respondents were not aware of a correlation between preoperative anaemia (POA) and perioperative morbidity and mortality. For 22%, treatment of POA was unlikely to favourably influence morbidity and mortality even before surgery with expected blood loss. More than half of clinicians did not routinely treat POA. 29%, when asked which is the best way to treat deficiency anaemia preoperatively, answered that they did not have sufficient knowledge and 5% chose to 'do nothing'. Amongst those who treated POA, 38% proposed red cell transfusion prior to surgery as treatment. Restrictive haemoglobin triggers for red blood cell transfusion, single unit policy and reduction of number and volumes of blood samples for diagnostic purposes were only marginally implemented. CONCLUSION: Overall, the responses indicated poor knowledge about PBM. Processes to diagnose and treat POA were not generally and homogeneously implemented. This survey should provide further impetus to implement programmes to improve knowledge and practice of PBM.

Patient Blood Management in Europe: surveys on top indications for red blood cell use and Patient Blood Management organization and activities in seven European university hospitals.

BACKGROUND AND OBJECTIVES: Patient Blood Management (PBM) in Europe is a working group of the European Blood Alliance with the initial objective to identify the starting position of the participating hospitals regarding PBM for benchmarking purposes, and to derive good practices in PBM from the experience and expertise in the participating teams with the further aim of implementing and strengthening these practices in the participating hospitals. METHODS: We conducted two surveys in seven university hospitals in Europe: Survey on top indications for red blood cell use regarding usage of red blood cells during 1 week and Survey on PBM organization and activities. RESULTS: A total of 3320 units of red blood cells were transfused in 1 week at the seven hospitals. Overall, 61% of red cell units were transfused to medical patients and 36% to surgical patients, although there was much variation between hospitals. The organization and activities of PBM in the seven hospitals were variable, but there was a common focus on optimizing the treatment of bleeding patients, monitoring the use of blood components and treatment of preoperative anaemia. CONCLUSION: Although the seven hospitals provide a similar range of clinical services, there was variation in transfusion rates between them. Further, there was variable implementation of PBM activities and monitoring of transfusion practice. These findings provide a baseline to develop joint action plans to further implement and strengthen PBM across a number of hospitals in Europe.

Donor cycle and donor segmentation: new tools for improving blood donor management.

BACKGROUND AND OBJECTIVES: An adequate donor population is of key importance for the entire blood transfusion chain. For good donor management, a detailed overview of the donor database is therefore imperative. This study offers a new description of the donor cycle related to the donor management process. It also presents the outcomes of a European Project, Donor Management IN Europe (DOMAINE), regarding the segmentation of the donor population into donor types. MATERIALS AND METHODS: Blood establishments (BEs) from 18 European countries, the Thalassaemia International Federation and a representative from the South-Eastern Europe Health Network joined forces in DOMAINE. A questionnaire assessed blood donor management practices and the composition of the donor population using the newly proposed DOMAINE donor segmentation. 48 BEs in 34 European countries were invited to participate. RESULTS: The response rate was high (88%). However, only 14 BEs could deliver data on the composition of their donor population. The data showed large variations and major imbalances in the donor population. In 79% of the countries, inactive donors formed the dominant donor type. Only in 21%, regular donors were the largest subgroup, and in 29%, the proportion of first-time donors was higher than the proportion of regular donors. CONCLUSION: Good donor management depends on a thorough insight into the flow of donors through their donor career. Segmentation of the donor database is an essential tool to understand the influx and efflux of donors. The DOMAINE donor segmentation helps BEs in understanding their donor database and to adapt their donor recruitment and retention practices accordingly. Ways to use this new tool are proposed.

[Work organisation improvement methods applied to activities of Blood Transfusion Establishments (BTE): Lean Manufacturing, VSM, 5S]. / Méthodes d'amélioration organisationnelle appliquées aux activités des établissements de transfusion sanguine (ETS): Lean manufacturing, VSM, 5S.

BACKGROUND: Continuous improvement of efficiency as well as new expectations from customers (quality and safety of blood products) and employees (working conditions) imply constant efforts in Blood Transfusion Establishments (BTE) to improve work organisations. METHODS: The Lean method (from "Lean" meaning "thin") aims at identifying wastages in the process (overproduction, waiting, over-processing, inventory, transport, motion) and then reducing them in establishing a mapping of value chain (Value Stream Mapping). It consists in determining the added value of each step of the process from a customer perspective. Lean also consists in standardizing operations while implicating and responsabilizing all collaborators. The name 5S comes from the first letter of five operations of a Japanese management technique: to clear, rank, keep clean, standardize, make durable. The 5S method leads to develop the team working inducing an evolution of the way in the management is performed. RESULTS: The Lean VSM method has been applied to blood processing (component laboratory) in the Pays de la Loire BTE. The Lean 5S method has been applied to blood processing, quality control, purchasing, warehouse, human resources and quality assurance in the Rhône-Alpes BTE. The experience returns from both BTE shows that these methods allowed improving: (1) the processes and working conditions from a quality perspective, (2) the staff satisfaction, (3) the efficiency. CONCLUSIONS: These experiences, implemented in two BTE for different processes, confirm the applicability and usefulness of these methods to improve working organisations in BTE.

[Patient blood management]. / Gestion du sang du patient et pour le patient.

OBJECTIVES: In a context of regular review of transfusion practice, the aim of this review is to present an update of the scientific basis of the so-called "patient blood management" (PBM), the state of its development in Europe, and possible ways to progress its development further in France. METHODS: Analysis and synthesis of the data from scientific literature on the scientific basis of PBM (methods, indications, efficacy, risks, efficiency). RESULTS: PBM appears as an evidence-based, patient centred, multidisciplinary approach, aiming to optimise the care of patients who might need transfusion and, consequently, the use of blood products. PBM is based on three pillars: optimise the patient's own blood supplies, minimise blood loss, optimise patient's tolerance of anaemia. Available scientific evidence can be considered as sufficient to consider PBM guidelines and practices as an indispensable complement to the transfusion medicine guidelines and practices. Several countries have launched PBM programmes (alternatives to allogeneic transfusion and optimisation of the use of blood components). Although current French national transfusion guidelines contain some PBM measures, PBM programmes should be further developed in France, primarily for medical reasons. CONCLUSIONS: Possible ways, using the existing basis having proved to be effective, are proposed to further develop PBM in France, as a complement to transfusion medicine, with the participation of involved stakeholders, including experts from relevant medical specialties, both at local and national levels.

The revision of the European blood directives: A major challenge for transfusion medicine.

AIM: Using both patient-focused and donor-focused perspectives, to review the current EU blood directives, in order to derive proposals, in principle, for what should evolve during the revision process of these directives. METHODS: Review of the EU blood directives in the light of scientific literature, related reports from the Directorate General Health and Consumers (DG SANTÉ), and from the Council of Europe (CoE). RESULTS: The analyses led us to present the main following proposals: developing voluntary unpaid donations: the directives should consider taking into consideration ethically acceptable forms of compensation consistent with altruistic donation (including plasma donations for fractionation); current expertise: more extensive utilization of the expertise of blood establishments and their consultants should be considered; donor selection: an evidence-based approach for basing donor deferral criteria on sound scientific evidence should be promoted; donor reactions: measures to prevent donor reactions and to make donations safer for the donors should also be included; quality control: The quality control requirements should relate to the Council of Europe Blood Guide specifications: these should become minimum standards (as is the case with monographs of the European Pharmacopeia), facilitating regular update of blood component lists and related specifications and compliance with the specifications; haemovigilance: because of reporting difficulties (e.g. lack of number of blood products transfused), the effectiveness of haemovigilance has so far been limited. This should lead appropriate bodies to investigate alternative or complementary ways to help improve patient safety, taking into consideration, in principle, patient blood management and the appropriate use of blood products. Furthermore, donor vigilance, which is still absent from the current directive should be included in a revised directive. CONCLUSIONS: These proposals for revising the current EU blood directives (if taken into account and given appropriate regulatory formulation) should help to optimize patient safety and donor care, progress the compliance with the ethical principles for donors and improve the efficiency of the healthcare systems dedicated to transfusion medicine.

Measurement of GPV released by activated platelets using a sensitive immunocapture ELISA--its use to follow platelet storage in transfusion.

Thrombin, the most potent platelet agonist, plays a central role in haemostasis and in the occurrence of thrombotic events. This agonist activates platelets by cleaving the PAR G-protein coupled receptors and by binding to glycoprotein (GP) Ib and also cleaves GPV at the platelet surface to liberate the soluble 69 kDa fragment GPVf1. Monoclonal antibodies (MoAbs) to GPV were developed as tools to study the mechanism of platelet GPV cleavage and measure release of GPV in pathological situations. Specificity of the MoAbs for GPV was confirmed by flow cytometry and immunoprecipitation of proteins from human platelets and Dami megakaryocytic cells. A sensitive immunocapture sandwich ELISA for soluble GPV was developed using two MoAbs recognizing different epitopes of GPV and purified platelet or recombinant GPV as reference protein. This ELISA was employed to determine the mean plasma concentration of GPV in 100 normal individuals (17.3 ng/ml), to demonstrate the dose-dependent release of GPVf1 from washed platelets stimulated with thrombin and to follow the progressive release of GPVf1 during storage of therapeutic platelet concentrates. The present report describes a sensitive GPV ELISA of direct application to survey the processing and storage of platelet concentrates for transfusion and of potential value to monitor platelet activation in thrombotic states.

Simultaneous enzymo-immunologic assays of platelet associated IgG, IgM and C3. A useful tool in assessment of immune thrombocytopenias.

A solid phase enzymo-immunologic assay (EIA) has been developed to measure platelet associated (PA) IgG, IgM and C3. Washed platelets are mixed with a goat anti-IgG (IgM or C3) antiserum and then incubated in serum coated polystyrene plates. There is an inverse relationship between the level of PA IgG (IgM or C3) and the amount of goat antibodies binding to the IgG (IgM or C3) coating the plates. These goat antibodies are detected by addition of a phosphatase-labelled sheep anti-goat immunoglobulins antibody followed by a substrate giving a colour reaction. Using this technique, platelets from normal donors gave values of 2.04 +/- 1.10 fg IgG/platelet (mean +/- SD), 8.66 +/- 2.61 x 10(-16) g IgM/platelet and 5.67 +/- 2.63 x 10(-16) g C3/platelet. In 35 thrombocytopenic ITP patients we observed an increased level of PA IgG in 25, of PA IgM in 24 and of PA C3 in 23, and all of them had at least an increase of one of the 3 components. In 10 ITP patients in remission, 2 had an increased level of PA IgG while PA IgM and C3 values were normal in all. On the other hand, 2 non thrombocytopenic patients with systemic lupus erythematosus had an increased level of PA IgM. Compared to the standard antiglobulin consumption assay (ACA), the EIA was simpler to perform and more sensitive.

Intravenous high-dose IgG therapy induced alterations of spleen lymphocyte IgM secretion and T cell subsets in patients with idiopathic thrombocytopenic purpura.

High-dose intravenous (IV) IgG therapy is an effective possible means of raising platelet counts in patients with idiopathic thrombocytopenic purpura (ITP). In order to elucidate further the mechanism of action of such treatment we comparatively studied spleen mononuclear cells (SMC) from two groups of ITP patients. Group I consisted of 9 patients who had not received any recent treatment before splenectomy. The 8 patients in group II had received IV IgG infusions 1-5 days before splenectomy. The SMC were cultured either unstimulated or stimulated by pokeweed-mitogen (PWM), and proliferation (as assessed by 3H-thymidine uptake), and IgG and IgM secretion were measured. In addition T lymphocyte subsets were determined in the SMC by indirect immunofluorescence using monoclonal antibodies (OKT3,4,8). By comparison with group I SMC, our results in group II SMC mainly showed a significant decrease in proliferation and IgM secretion, in both unstimulated and PWM stimulated cultures. In addition, a significant decrease in the proportion of T helper-inducer lymphocytes (OKT4+ cells) was also found in group II SMC, as compared to group I SMC. However, these immunological alterations in group II SMC were paradoxically more pronounced in those patients who failed to respond to IV IgG infusions. Thus, these results suggest that, although immune suppression takes place in the SMC of ITP patients following IV IgG therapy, it has not a pronounced effect on the increase of platelet.

Apheresis-elutriation program for adoptive immunotherapy with autologous activated monocytes in cancer patients.

Human blood monocytes (Mo) and monocyte-derived macrophages (M phi) are known to be potent antitumor cytotoxic effector cells through activation with recombinant human interferon gamma (rIFN-gamma), bacterial muramyldipeptide or the synthetic derivative muramyltripeptide phosphatidylethanolamine entrapped in liposomes (L-MTP-PE). Large-scale generation of ex vivo activated Mo from the blood of cancer patients proved feasible. We report our experience with a fixed rotor speed counterflow centrifugation elutration (CEE) procedure using the newly available Beckman high capacity JE-5.0 rotor system that reproducibly isolates up to 1.0-1.5 x 10(9) Mo with greater than 90% purity, in suspension and functionally intact derived from peripheral blood mononuclear cell-enriched suspensions obtained by leukapheresis (LP) from healthy volunteers and cancer patients. The semiclosed, easy to handle CCE system, was adapted to a sterile technique that permitted clinical trials in adoptive monocyte immunotherapy. Freshly isolated Mo did not lose morphological or functional integrity and had no spontaneous activation. Their abilities to become activated to the cytotoxic state after 18-h stimulation with 500 U/ml rIFN-gamma or 1 microgram/ml L-MTP-PE and to differentiate into matured M phi in vitro were not altered. The system was therefore used to isolate large numbers of Mo for a phase I clinical trial of intraperitoneal immunotherapy with L-MTP-PE activated autologous Mo in nine patients with peritoneal carcinomatosis. Each patient received weekly Mo infusions (n = 5) with an intrapatient dose escalation schedule (from 10(7) to 10(9) Mo). Toxicities were mild including fever, chills and abdominal pain. There was no treatment-induced thromboembolic event or capillary leak syndrome.(ABSTRACT TRUNCATED AT 250 WORDS)

A randomized study of on-line plasma perfusion over protein A-sepharose and 5-fluorouracil chemotherapy in patients with metastatic colorectal carcinoma.

To evaluate the safety of on-line plasma perfusion over protein-A sepharose and the therapeutic advantage of combining plasma perfusion (PP) over protein-A sepharose with 5-fluorouracil (5-FU) chemotherapy in patients with metastatic colorectal carcinoma (MCRC), thirty patients were randomized after surgery of primary CRC to receive a combination of 5-FU and PP over protein-A sepharose (group A), or a combination of 5-FU and PP over sepharose (group B), or 5-FU alone (group C). Bi-weekly on-line PP over 200 ml protein-A sepharose gel (group A) or 200 ml sepharose gel (group B) were performed with a Cobe 2997 blood cell separator for a maximum of 19 treatments per patient. 5-FU was given at 1000 mg/m2/d on days 1-5 of a 4-weekly cycle until progression. PP was well tolerated and no severe or life-threatening toxicity was observed. Mild clinical side-effects consisted of fever and chills (36% in group A, 23% in group B). The most common biological effects of PP over protein-A sepharose were significant drops in IgG (66% of pre-PP values), CH50 and C3 (73% of pre-PP values) and a significant generation of C3a and C5a anaphylatoxins. Tumor response rates were 40% for group A, 0% for group B and 20% for group C. The median survival times tended to be longer in group A (17 months) than in group B (10 months) and in group C (9 months). This is the first randomized trial showing some therapeutic advantage in combining PP over protein-A sepharose with conventional chemotherapy in MCRC.

[Plasma-derived products: therapeutic biological products]. / Produits dérivés du plasma: des produits biologiques à effet thérapeutique.

The status of proprietary medicinal product has been conferred upon plasma derived products (PDP) by the European Community in its directive issued on the 14 of June 1989. This directive requires each Member State to comply with the current regulations applicable to medicinal products related to production, control and registration of PDP. A different evolution characterized the American regulation in which PDP have been classified as biological products, submitted to a particular regulation since 1992. These different conceptions led the authors to systematically review the specificities of PDP in comparison to classical medicinal products: plasmatic raw material, production of active ingredients and manufacturing of products in the same facility, divergent production of several products from a single starting material, infection risks and variability characterizing biological products, registration and distribution. The analysis of complementary regulation issued to adapt the pharmaceutical principles to the PDP shows that it does not provide all the expected answers to the specificities of the PDP. This shows the advantages that could be expected by giving a status of biological therapeutic product to the PDP. This could above all allow to federate qualified people and data in order to take into account more accurate and more immediate information about risks which may arise in very dispersed fields. This could also serve as a reminder of the ethical principles attached to the preparation of products coming from a human source.

[Comparative validation of manual and automated methods for mixing and volume control of total blood samples]. / Validation comparative de méthodes manuelle et automatisée pour l'agitation et le contrôle de volume des prélèvements de sang total.

During blood collection, agitation and volume limitations are critical to ensure thorough mixing of the blood with the anticoagulant and obtention of the predetermined volume. These 2 factors are essential to prevent blood activation and to obtain well standardized blood products. The objective of this study was to compare the quality of the blood collected using 2 types of collection method: tripping of a scale at a predetermined volume limit of 450 mL in the presence of manual agitation, and the 3 blood collection monitors currently available in France. A minimum of 100 collection procedures was performed for each of the 4 methods tested. Results were found to be equivalent using either the manual or the automated procedures with regard to both the accuracy and reproducibility of the blood volumes obtained and the collection times and flow rates. The characteristics of the red blood cell concentrates, platelet concentrates and plasma units prepared from the first 30 collections of each group were assessed and compared to regulatory requirements. The quality of all these products was found to be comparable to that currently observed at quality control and no product was rejected at the release control for reasons of poor collection. An assessment of the practicability of the different methods showed that the automated devices are subject to practical difficulties involving transport and battery loading. In addition, the cost of this equipment is approximately 5 times higher than that of the scales. In conclusion, the results of this study show that in our hands, no significant advantage could be expected from the use of automated blood collection monitors as compared to simple scales with manual mixing. These results further raise the question of the applicability to labile blood products of the comparative validations currently accepted in the pharmaceutical industry, in order to allow the use of correctly validated alternative methods.

[Staff certification for mobile blood collection units]. / Une expérience de certification du personnel des prélèvements en collectes mobiles.

Training and official acknowledgment of the competence of each staff member are essential to the quality and safety of collected blood products prepared and delivered by a blood transfusion center. A procedure was created to indicate in detail the methods employed to implement such accreditation. Based on individual training according to activity, it defines for each type of activity (secretary, physician, collector, driver) the required theoretical and practical knowledge of his/her position. Accreditation, consisting of assessment of the degree of competence attained in these areas of responsibility, was applied to the members of mobile blood collection teams in 1995. No major deficiency was detected, and this certification was well accepted by the staff. In order to complete this initial accreditation, blood collection abnormalities (inadequate blood volumes, clots or defective welding of tubing) were assessed for each collector individually. Comparison of these abnormalities in qualified nurses and laboratory technicians with a blood collection diploma showed no differences. On the other hand, significantly higher numbers of abnormalities were found in intermittent as compared to regular collectors and in senior as compared to new collectors. The applied corrective measures led to obviation of differences and improvement in performance. In 1996, in the first individual evaluation of medical selection carried out by each physician, discrepancies of one to 20 donors (0.7-14.2%) were observed from one doctor to another in the frequency of elimination of candidates for blood donation after the medical interview. Regular meetings with physicians resulted in reducing these discrepancies to one to 3.1 donors (4.6-14.1%) in 1997. In conclusion, the association of an initial accreditation procedure with an individual follow-up of work quality allowed satisfactory assessment of the training and competence of staff members. This kind of method could be extended to those working in other fields of transfusion medicine.

[Evaluation of measurements intended to develop regularity of blood donation]. / Evaluation de mesures destinées à développer la régularité du don de sang.

An increase in the regularity of blood donation is desirable for two main reasons. First, the lower incidence of viral disease markers in regular donors when compared to first donors could help to reduce risks of transmissible diseases. Second, a higher frequency of donation could contribute to a more satisfactory supply of blood products. Two measures implemented with the aim of increasing the regularity of blood donation were evaluated: (i) an increase in the annual frequency of blood collection by mobile teams at collection sites, and (ii) a "next donation document" given to each donor indicating the earliest possible date of the next donation. The regularity index was calculated as the mean number of cellular donations (whole blood and platelet apheresis) per donor per year, over two consecutive periods: 1-7-1993-30-6-1994 (P1) and 1-7-1994-30-6-1995 (P2). The junction of these two periods corresponded to the date of introduction of the "next donation document" and to the time of reinforcement of the mobile collection frequency. First donors in either period were not taken into account in the study. A significant relationship was observed between the annual frequency of mobile collection and the average number of donations per donor (comparison test of two means on large samples, p < 0.001 in all the cases excepted those of stable mobile collection numbers). Thus, in the first period, the average donation rate was the lowest on sites having only one mobile collection per year (M: 1.55, W: 1.38) and the highest on sites with five mobile collections per year (M: 2.05, W: 1.71). These average numbers significantly increased in the second period as compared to the first (M: +4.8%, W: +1.8%; comparison test of two means from paired series, p < 0.001), as did the yearly frequency of mobile blood collections (+9.2%). On the other hand, the "next donation document" was not associated to any change in the regularity index. The results of this study therefore showed an increase in the frequency of visits of mobile collection teams to be the main factor leading to an improvement in the regularity of blood donation. Moreover, this evolution was associated with a decrease in the incidence of viral markers detected at donation.

Satisfaction survey in general hospital personnel involved in blood transfusion: implementation of the ISO 9001: 2000 standard.

As part of its policy of constant quality improvement, Etablissement francais du sang (EFS) des pays de la Loire (Pays de la Loire Regional Blood Transfusion Centre) carried out a satisfaction survey among the hospital personnel involved in prescribing and using immunohaematological tests and labile blood products (LBP). The polling tool selected by agreement between the Saint Nazaire's hospital management and Quality Assurance (QA) Department was a questionnaire that permitted item rating and free commentary. It addressed the personnel's perception of the quality of erythrocyte immunohaematological (EIH) testing and of the products administered, as well as their perception of the quality of communications with the local EFS. The questionnaire was sent to 26 physicians and 32 senior nurses in 15 hospital departments. The reply rate was 60% and expressed an 85% overall satisfaction level. Dissatisfaction causes were more specifically analysed, the main one involving LBP distribution in emergency situations. A joint undertaking by the EFS and the hospital led to the implementation of corrective measures, including the writing and implementation of a common standard operating procedure for emergency transfusion management. The results obtained demonstrated the feasibility of this type of survey and the interest, to a blood transfusion centre and the hospital personnel involved in transfusion, of assessing their very own perception of service quality.

[Satisfaction survey in general hospital personnel involved in blood transfusion: implementation of the ISO 9001: 2000 standard]. / Enquête de satisfaction des acteurs impliqués dans la transfusion dans un centre hospitalier général: une application de la norme ISO 9001: 2000.

As part of its policy of constant quality improvement, Etablissement Français du Sang (EFS) des Pays de la Loire (Pays de la Loire Regional blood transfusion institution) carried out a satisfaction survey among the hospital personnel involved in prescribing and using immuno-hematological tests and labile blood products. The polling tool selected by agreement between the hospital management and quality assurance department was a questionnaire that permitted item rating and free commentary. It addressed the personnel's perception of the quality of erythrocyte immuno-hematological (EIH) testing and of the products administered, as well as their perception of the quality of communications with the local EFS. The questionnaire was sent to 26 physicians and 32 senior nurses in 15 hospital departments. The reply rate was 60% and expressed a 85% overall satisfaction level. Dissatisfaction causes were more specifically analysed, the main one involving labile blood product distribution in emergency situations. A joint undertaking by the EFS and the hospital led to the implementation of corrective measures, including the writing and implementation of a common standard operating procedure for emergency transfusion management. The results obtained demonstrated the feasibility of this type of survey and the interest, to a blood transfusion centre and the hospital personnel involved in transfusion, of assessing their very own perception of service quality.

[Quantitative bacteriological evaluation of a method for skin disinfection in blood donors]. / Evaluation bactériologique quantitative d'une méthode de désinfection cutanée chez les donneurs de sang.

Skin disinfection at the site of venipuncture is a critical point in every blood transfusion collection procedure, as it contributes to ensure the bacterial safety of transfusion. Quantitative and qualitative analysis of bacteria present in the antecubital fossae before and after skin disinfection may be one method of assessing the anti-bacterial efficiency of disinfection. Swab culture systems and contact plates are the two techniques usually employed for this purpose. A washing and swabbing technique was used to quantify bacteria before and skin disinfection of the antecubital fossae in blood donors. This contra-placebo study was carried out on 32 donors, each of whom served as his own control, with a random choice of test arm and opposing control arm. Bacterial counts were determined in the antecubital fossae without skin disinfection (control, n = 32) and after a 3 step skin preparation procedure (cleaning, wiping, disinfection) using placebo (distilled water, n = 16) or an antiseptic product (mixture of chlorexidine, benzalkonium chloride and benzylic alcohol, n = 16). The absence of a statistical difference in bacterial counts between the right and left antecubital fossae without disinfection was controlled in a preliminary study of 20 subjects. Mean bacterial counts were 25,000/cm2 and 27,400/cm2 respectively for aerobic and anaerobic bacteria before disinfection, with a wide variation in results between individuals. When using placebo, preparation of the venipuncture site by the 3 step method (cleaning, wiping, disinfection) resulted in a non significant mean reduction of 0.56 log in aerobic and anaerobic bacteria. Using the antiseptic product, the same method resulted in a significant mean reduction of 1.8 and 1.7 log respectively in aerobic (p = 0.015) and anaerobic flora (p = 0.005). On an average, 2,750 aerobic bacteria/cm2 and 2,910 anaerobic bacteria/cm2 remained after disinfection, while qualitative analysis showed that disinfection suppressed the transitory flora in all cases but left part of the resident flora in 12/16 cases. These findings are comparable to those of other studies carried out to evaluate this kind of technique for the disinfection of operation sites. In comparison with other techniques classically employed for this type of evaluation (swab systems or contact plates), the method used in this study was the advantage of allowing the quantification of the reduction in bacteria. Hence this method could be employed for comparative assessment of skin disinfection techniques with the aim of improving their anti-bacterial efficiency and could also make possible the definition of a minimum bacterial count (resident flora) to be obtained in all cases after disinfection.