Analysis of Transfusion-Related Acute Lung Injury and Possible Transfusion-Related Acute Lung Injury Reported to the French Hemovigilance Network From 2007 to 2013.

Using the French Hemovigilance Network database from 2007 to 2013, we provide information on demographics, incidence, and risk factors of reported transfusion-related acute lung injury (TRALI) and possible TRALI, analyze TRALI mitigation efforts for fresh frozen plasma and platelet concentrates, and consider the impact of platelet additive solutions on TRALI incidence. We applied the Toronto consensus conference definitions for TRALI and possible TRALI. Two TRALI subgroups were considered: "antibody positive" when a donor has human leukocyte antigen (class I or II) and/or human neutrophil antigen antibodies and the recipient has cognate antigen, and "antibody negative" when immunological investigation is negative or not done. The analysis targeted 378 cases, divided into antibody-positive TRALI (n=75), antibody-negative TRALI (n=100), and possible TRALI (n=203). TRALI patients were younger and received more blood components than the general population of transfused patients. Moreover, we identified the following clinical conditions where patients seemed to be at higher risk to develop TRALI: postpartum hemorrhage, acute myeloid leukemia, liver transplantation, allogeneic and autologous hematopoietic stem cells transplantation, polytrauma, and thrombotic microangiopathy. Policy measures intended to reduce antibody-positive TRALI were found effective for apheresis platelet concentrates and fresh frozen plasma but not for whole blood-derived platelet concentrates. The use of platelet additive solutions was associated with a significant reduction in the incidence of TRALI following transfusion of buffy coat-derived platelet concentrates but not following transfusion of apheresis platelets. Our data reinforce the concept that possible TRALI and TRALI, as defined in the Canadian consensus conference, share many characteristics. No specific policy measures are currently directed at mitigation of possible TRALI despite its impact on transfusion safety. Despite TRALI mitigation measures, the overall incidence of TRALI cases reported to the French Hemovigilance system was not significantly reduced. Therefore, additional research is needed to reduce, if not eradicate, all TRALI categories.

Blood products use in France: a nationwide cross-sectional survey.

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 × 109 and 50 × 109 /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.

Assessment of the contribution of morbidity and mortality conferences to quality and safety improvement: a survey of participants' perceptions.

BACKGROUND: Evidence for the effectiveness of the morbidity and mortality conferences in improving patient safety is lacking. The aim of this survey was to assess the opinion of participants concerning the benefits and the functioning of morbidity and mortality conferences, according to their organizational characteristics. METHODS: We conducted a survey of professionals involved in a morbidity and mortality conference using a self-administered questionnaire in three French teaching hospitals in 2012. The questionnaire focused on the functioning of morbidity and mortality conferences, the perceived benefits, the motivations of participants, and how morbidity and mortality conferences could be improved. The perception of participants was analysed according to the characteristics of morbidity and mortality conferences. RESULTS: A total of 698 participants in 54 morbidity and mortality conferences completed the questionnaire. Most of them (91 %) were satisfied with how the morbidity and mortality conference they attended was conducted. The improvements in healthcare quality and patient safety were the main benefits perceived by participants. Effectiveness in improving safety was mainly perceived when cases were thoroughly analysed (adjusted odds ratio [a0R] =2.31 [1.14-4.66]). The existence of a written charter (p = 0.05), the use of a standardized case presentation (p = 0.049), and prior dissemination of the meeting agenda (p = 0.02) were also associated with the perception of morbidity and mortality conference effectiveness. The development and achievement of improvement initiatives were associated with morbidity and mortality conferences perceived as being more effective (p < 0.01). Participants suggested improving the attendance of medical and paramedical professionals to enhance the effectiveness of morbidity and mortality conferences. CONCLUSIONS: Morbidity and mortality conferences were positively perceived. These results suggest that a structured framework and thoroughly analyzing cases improve their effectiveness.

Characteristics of morbidity and mortality conferences associated with the implementation of patient safety improvement initiatives, an observational study.

BACKGROUND: The aim of this study was to identify the characteristics of morbidity and mortality conferences (MMCs) associated with the implementation of patient health-care quality and safety improvement initiatives. METHODS: We conducted an observational study of MMCs and followed up improvement initiatives for 1 year. Data on MMC baseline characteristics were abstracted using document analysis and observation of a meeting in three university hospitals in France (Grenoble, Nice, and Cochin [Paris] hospitals). Fifty-nine MMCs were included in medical (n = 24), surgical (n = 21), and anesthesiology and/or intensive care (n = 14) departments. An effectiveness index was computed by summing a composite score for each initiative pertaining to the MMC. RESULTS: Overall, 282 initiatives were identified in 42 MMCs. During the follow-up period, 215 initiatives (76%) were totally or partially implemented and the impact was evaluated for 73 (26%). An effectiveness index higher than the median (i.e., ≥10) was associated with a standardized presentation of cases (81% versus 29%, p <0.001), recording of improvement initiatives (94 versus 57, p = 0.001), the existence of an annual activity report (94% versus 68%, p = 0.01), the prior dissemination of a meeting agenda (71% versus 36%, p = 0.007), longer meeting duration (109 versus 80 min, p = 0.005), anesthesiology and/or intensive care specialty (39% versus 7%, p = 0.02), a theme-focused MMC (29% versus 4 %, p = 0.01), and a thorough analysis of failures (58% versus 25%, p = 0.01). CONCLUSIONS: This study suggests that the implementation of improvement initiatives relates to MCC characteristics. Recommendations for developing more effective patient safety-oriented MMCs can be proposed.

[Blood transfusion and supply chain management safety]. / Transfusion sanguine : la sécurité de la chaîne.

The level of safety attained in blood transfusion now makes this a discipline better managed care activities. This was achieved both by scientific advances and policy decisions regulating and supervising the activity, as well as by the quality system, which we recall that affects the entire organizational structure, responsibilities, procedures, processes and resources in place to achieve quality management. So, an effective quality system provides a framework within which activities are established, performed in a quality-focused way and continuously monitored to improve outcomes. This system quality has to irrigate all the actors of the transfusion, just as much the establishments of blood transfusion than the health establishments.

From the description of activities to the identification of risks for clinical management: a proposal of building, merging and sharing knowledge representations of care processes.

Management of clinical processes and hospital activities takes advantage of business process reengineering methodology. It is now recognized that care process modeling must integrate the definition of goals and the assessment of risk. Two kinds of issues have been outlined: 1) the lack of an integrated model to identify and describe processes and their components according to a functional point of view; and 2) an increasing amount of documents that hospital staff members have to create, collect, index and maintain. As initial models focused only on a structural view of activities, we reviewed different sources of standards and norms to extract and classify a set of metadata aimed at describing any activity and its outcomes. The model includes links to structured terminologies to name attributes or value them. An object-oriented information model has been created and implemented to test the relevance and the feasibility of the modeling approach. Conceptually speaking, this model gives opportunity to bridge tacit and explicit knowledge. Practically speaking, limits to generalization remain partly due to the lack of a template processes database.

[Evaluation of the professional practices of physicians in transfusion technology and medicine]. / L'évaluation des pratiques professionnelles des médecins en technologie et médecine transfusionnelles.

The evaluation of the professional practices (EPP) is obligatory for all the physicians since July 1, 2005 for a first five-year period. It represents one of the components of the continuous medical training (CMT). The French Society of Blood Transfusion and National Institute of Blood Transfusion are the promoters of the EPP in transfusion technology and medicine. Initially, the programs of EPP will be conceived and controlled by experts and will relate to their basic activities. During a five years cycle, the physician taking part in a program must validate a specific action and take part in a rolling programme. At the end of the programme, the physician will receive a certificate issued by National Institute of Blood Transfusion and will have to submit it to a committee placed under the responsibility of the regional physicians' committee.

Mapping care processes within a hospital: from theory to a web-based proposal merging enterprise modelling and ISO normative principles.

Today, the economic and regulatory environment, involving activity-based and prospective payment systems, healthcare quality and risk analysis, traceability of the acts performed and evaluation of care practices, accounts for the current interest in clinical and hospital information systems. The structured gathering of information relative to users' needs and system requirements is fundamental when installing such systems. This stage takes time and is generally misconstrued by caregivers and is of limited efficacy to analysts. We used a modelling technique designed for manufacturing processes (IDEF0/SADT). We enhanced the basic model of an activity with descriptors extracted from the Ishikawa cause-and-effect diagram (methods, men, materials, machines, and environment). We proposed an object data model of a process and its components, and programmed a web-based tool in an object-oriented environment. This tool makes it possible to extract the data dictionary of a given process from the description of its elements and to locate documents (procedures, recommendations, instructions) according to each activity or role. Aimed at structuring needs and storing information provided by directly involved teams regarding the workings of an institution (or at least part of it), the process-mapping approach has an important contribution to make in the analysis of clinical information systems.

Mapping care processes within a hospital: a web-based proposal merging enterprise modelling and ISO normative principles.

Today, the economic and regulatory environment are pressuring hospitals and healthcare professionals to account for their results and methods of care delivery. The evaluation of the quality and the safety of care, the traceability of the acts performed and the evaluation of practices are some of the reasons underpinning current interest in clinical and hospital information systems. The structured collection of users' needs and system requirements is fundamental when installing such systems. This stage takes time and is generally misconstrued by caregivers and is of limited efficacy to analysis. We used a modelling technique designed for manufacturing processes (SADT: Structured Analysis and Design Technique). We enhanced the initial model of activity of this method and programmed a web-based tool in an object-oriented environment. This tool makes it possible to extract the data dictionary from the description of a given process and to locate documents (procedures, recommendations, instructions). Aimed at structuring needs and storing information provided by teams directly involved regarding the workings of an institution (or at least part of it), the process mapping approach has an important contribution to make in the analysis of clinical information systems.

Towards elicitation of users requirements for hospital information system: from a care process modelling technique to a web based collaborative tool.

Growing attention is being given to the use of process modeling methodology for user requirements elicitation. In the analysis phase of hospital information systems, the usefulness of care-process models has been investigated to evaluate the conceptual applicability and practical understandability by clinical staff and members of users teams. Nevertheless, there still remains a gap between users and analysts in their mutual ability to share conceptual views and vocabulary, keeping the meaning of clinical context while providing elements for analysis. One of the solutions for filling this gap is to consider the process model itself in the role of a hub as a centralized means of facilitating communication between team members. Starting with a robust and descriptive technique for process modeling called IDEF0/SADT, we refined the basic data model by extracting concepts from ISO 9000 process analysis and from enterprise ontology. We defined a web-based architecture to serve as a collaborative tool and implemented it using an object-oriented database. The prospects of such a tool are discussed notably regarding to its ability to generate data dictionaries and to be used as a navigation tool through the medium of hospital-wide documentation.