Impact of an Original Methodological Tool on the Identification of Corrective and Preventive Actions After Root Cause Analysis of Adverse Events in Health Care Facilities: Results of a Randomized Controlled Trial.

OBJECTIVE: The aim of the study was to assess the effectiveness of a new methodological tool for the identification of corrective and preventive actions (CAPAs) after root cause analysis of health care-related adverse events. METHODS: From January to June 2010, we conducted a randomized controlled trial involving risk managers from 111 health care facilities of the Aquitaine Regional Center for Quality and Safety in Health Care (France). Fifty-six risk managers, randomly assigned to two groups (intervention and control), identified CAPAs in response to two sequentially presented adverse event scenarios. For the baseline measure, both groups used their usual adverse event management tools to identify CAPAs in each scenario. For the experimental measure, the control group continued using their usual tools, whereas the intervention group used a new tool involving a systemic approach for CAPA identification. The main outcome measure was the number of CAPAs the participants identified that matched a criterion standard established by eight experts. RESULTS: Baseline mean number of identified CAPAs did not differ between the two groups (P = 0.83). For the experimental measure, significantly more CAPAs (P = 0.001) were identified by the intervention group (mean [SD] = 4.6 [1.7]) than by the control group (mean [SD] = 2.8 [1.2]). CONCLUSIONS: For the two scenarios tested, more relevant CAPAs were identified with the new tool than with usual tools. Further research is needed to assess the effectiveness of the new tool for other types of adverse events and its impact on patient safety.

Improving the safety climate in hospitals by a vignette-based analysis of adverse events: a cluster randomised study.

OBJECTIVE: To assess the impact of a vignette-based analysis of adverse events (AEs) on the safety climate (SC) of care units. DESIGN: Prospective, open, cluster (a unit) randomised controlled trial. SETTING: Eighteen acute care units of seven hospitals in France. PARTICIPANTS: Healthcare providers who worked in the units. INTERVENTION: Vignette-based analyses of AEs were conducted with unit's providers once per month for six consecutive months. The AEs were real cases that occurred in other hospitals. The hospital risk manager conducted each analysis as follows: analysis of the immediate and root causes of the AE; assessment of the care unit's vulnerabilities and existing barriers in the occurrence of an identical AE and search for solutions. MAIN OUTCOME MEASURE: SC was measured using the French version of the Hospital Survey on Patient Safety Culture questionnaire. The primary outcome was the difference in the 'Organisational learning and continuous improvement' dimension score, from before to after the analyses. RESULTS: Median participation rate in the analyses was 20% (range: 7-45%). Before intervention, the response rate to the SC survey was 80% (n = 210) in the intervention group and 73% (n = 191) in the control group. After intervention, it was 59% (n = 141) and 63% (n = 148), respectively. The dimension score evolved differently for the groups from before to after intervention (intervention: +10.2 points ±8.8; control: -3.0 points ±8.5, P = 0.04). Side effects were not measured. CONCLUSIONS: Vignette-based analysis was associated with the improvement of the perception of participants regarding their institution's capacity for organisational learning and continuous improvement.

Insurance statements related to regional anaesthesia: A French database analysis.

BACKGROUND: Adverse events in the perioperative period remain frequent, occurring in about 30% of the hospital admission and may be avoidable in nearly 50% of cases. Improving safety needs a continuous assessment of the risk level. MATERIAL AND METHODS: Data from the MACSF-Sou medical insurance company, including all the statements declared by anaesthesiologists and intensivists, were analyzed retrospectively by three experts, senior anaesthesiologists, of the SFAR, the French society of anesthesia and intensive care (Société française d'anesthésie réanimation) to describe the risk associated with regional anaesthesia. RESULTS: One hundred and sixty-four events were analyzed, involving young patients (mean age of 48.3±15years; sex ratio: 0.57). The most involved surgical specialties were: orthopaedic surgery (61%) and obstetric surgery (13.4%). Reported events were predominantly peripheral nerve injury (64.6%). Mechanical complications of puncture (pneumothorax, haemothorax, complications of axial punctures) accounted for approximately 15% of events, infection for 11%. The revelation was predominant in the postoperative course (137 cases, 83.6%), particularly after the release of the operating room in over 47% of cases, including 39 cases (22%) after discharge from the hospital. CONCLUSION: Collaboration with insurance companies allows a relevant approach of the perioperative risk. In most cases, liability related to regional anaesthesia involved young patients in the perioperative course of scheduled surgery. One of the future challenges in managing, the anaesthetic and perioperative risks should be to invest more accurately the postoperative care both in the hospital or ambulatory settings.

Insurance statements from French anaesthesiologists and intensivists: A database analysis.

BACKGROUND: From its origins, anaesthesia is a leading medical specialty for improving patient safety. However, perioperative adverse events remain frequent and may be preventable in 50% of cases. We conducted a collaborative retrospective study analysis of the insurance-database of the MACSF-Sou Medical insurance company to assess the perioperative risk. MATERIAL AND METHODS: Retrospective study, including all the statements declared by anaesthesiologists to the MACSF-Sou Medical insurance company. A description of risk in perioperative medicine was performed by the assessment of these statements by three experts member of the SFAR. All the statements concerning regional anaesthesia and dental injuries were excluded. RESULTS: Eight hundred and seventy statements were analyzed. The patients involved were predominantly women (sex-ratio: 0.86), with a mean age of 56 years (±18). Three hundred and fifteen cardiac arrests, 157 severe systemic complications, 340 moderate complications and 106 conflicts were analyzed. Most of the events were revealed postoperatively (79.3%) and almost half of them after the discharge of the postanesthetic care unit. The medical consequences were considered as serious. Death followed 35.9% of the events declared. Relative or true hypovolaemia and stroke were responsible for a large part of postoperative mortality and morbidity. CONCLUSION: Collaborating with insurance companies allows a relevant approach of the perioperative risk. The study highlighted the importance of the delayed complications and is a plea for a more intense implication of anaesthesia in the postoperative care with the aim of improving patient safety.

A Serious Game for Massive Training and Assessment of French Soldiers Involved in Forward Combat Casualty Care (3D-SC1): Development and Deployment.

BACKGROUND: The French Military Health Service has standardized its military prehospital care policy in a ''Sauvetage au Combat'' (SC) program (Forward Combat Casualty Care). A major part of the SC training program relies on simulations, which are challenging and costly when dealing with more than 80,000 soldiers. In 2014, the French Military Health Service decided to develop and deploy 3D-SC1, a serious game (SG) intended to train and assess soldiers managing the early steps of SC. OBJECTIVES: The purpose of this paper is to describe the creation and production of 3D-SC1 and to present its deployment. METHODS: A group of 10 experts and the Paris Descartes University Medical Simulation Department spin-off, Medusims, coproduced 3D-SC1. Medusims are virtual medical experiences using 3D real-time videogame technology (creation of an environment and avatars in different scenarios) designed for educational purposes (training and assessment) to simulate medical situations. These virtual situations have been created based on real cases and tested on mannequins by experts. Trainees are asked to manage specific situations according to best practices recommended by SC, and receive a score and a personalized feedback regarding their performance. RESULTS: The scenario simulated in the SG is an attack on a patrol of 3 soldiers with an improvised explosive device explosion as a result of which one soldier dies, one soldier is slightly stunned, and the third soldier experiences a leg amputation and other injuries. This scenario was first tested with mannequins in military simulation centers, before being transformed into a virtual 3D real-time scenario using a multi-support, multi-operating system platform, Unity. Processes of gamification and scoring were applied, with 2 levels of difficulty. A personalized debriefing was integrated at the end of the simulations. The design and production of the SG took 9 months. The deployment, performed in 3 months, has reached 84 of 96 (88%) French Army units, with a total of 818 hours of connection in the first 3 months. CONCLUSIONS: The development of 3D-SC1 involved a collaborative platform with interdisciplinary actors from the French Health Service, a university, and videogame industry. Training each French soldier with simulation exercises and mannequins is challenging and costly. Implementation of SGs into the training program could offer a unique opportunity at a lower cost to improve training and subsequently the real-time performance of soldiers when managing combat casualties; ideally, these should be combined with physical simulations.

Hospital audit of delayed transfusion after orthopaedic surgery.

BACKGROUND AND OBJECTIVES: To understand the mechanisms related to both the onset and correction of severe anaemia after orthopaedic surgery, we analysed all the full blood counts (FBCs) for patients on one orthopaedic ward during a one-year period in an academic hospital. METHODS: FBCs were screened and the medical records of those patients for whom a postoperative haemoglobin (Hb) concentration below 8 g/dL was recorded at least once were reviewed. The onset of postoperative anaemia was determined by calculating the various time intervals delineated by surgery, the time at which the transfusion threshold was reached and the time at which the lowest Hb level (nadir) and transfusion (if any) occurred. RESULTS: A total of 6573 FBCs drawn from 1255 patients were screened. The medical records of 74 consecutive patients with at least one Hb value < 8 g/dL were analysed. The postoperative Hb nadir was 7.4 (± 0.6) g/dL (mean - SD). The medians (IQR 25-75) of the calculated intervals were: (surgery - nadir): 72 (48-144) h, (nadir - transfusion): 7 (5-21) h and (transfusion threshold - transfusion): 26 (11-51) h. CONCLUSIONS: Delayed transfusion (defined as > 12 hours between the time at which the transfusion threshold was reached and actual transfusion) was observed in 57% of severely anaemic patients after orthopaedic surgery.

A simulator-based study of in-flight auscultation.

INTRODUCTION: The use of a stethoscope is essential to the delivery of continuous, supportive en route care during aeromedical evacuations. We compared the capability of 2 stethoscopes (electronic, Litmann 3000; conventional, Litmann Cardiology III) at detecting pathologic heart and lung sounds, aboard a C135, a medical transport aircraft. METHODS: Sounds were mimicked using a mannequin-based simulator SimMan. Five practitioners examined the mannequin during a fly, with a variety of abnormalities as follows: crackles, wheezing, right and left lung silence, as well as systolic, diastolic, and Austin-Flint murmur. The comparison for diagnosis assessed (correct or wrong) between using the electronic and conventional stethoscopes were performed as a McNemar test. RESULTS: A total of 70 evaluations were performed. For cardiac sounds, diagnosis was right in 0/15 and 4/15 auscultations, respectively, with conventional and electronic stethoscopes (McNemar test, P = 0.13). For lung sounds, right diagnosis was found with conventional stethoscope in 10/20 auscultations versus 18/20 with electronic stethoscope (P = 0.013). CONCLUSIONS: Flight practitioners involved in aeromedical evacuation on C135 plane are more able to practice lung auscultation on a mannequin with this amplified stethoscope than with the traditional one. No benefit was found for heart sounds.

Brief report: pulmonary auscultation in the operating room: a prospective randomized blinded trial comparing electronic and conventional stethoscopes.

BACKGROUND: We compared the subjective quality of pulmonary auscultation between 2 acoustic stethoscopes (Holtex Ideal® and Littmann Cardiology III®) and an electronic stethoscope (Littmann 3200®) in the operating room. METHODS: A prospective double-blind randomized study with an evaluation during mechanical ventilation was performed in 100 patients. After each examination, the listeners using a numeric scale (0-10) rated the quality of auscultation. Auscultation quality was compared in patients among stethoscopes with a multilevel mixed-effects linear regression with random intercept (operator effect), adjusted on significant factors in univariate analysis. A significant difference was defined as P < 0.05. RESULTS: One hundred comparative evaluations of pulmonary auscultation were performed. The quality of auscultation was rated 8.2 ± 1.6 for the electronic stethoscope, 7.4 ± 1.8 for the Littmann Cardiology III, and 4.6 ± 1.8 for the Holtex Ideal. Compared with Holtex Ideal, auscultation quality was significantly higher with other stethoscopes (P < 0.0001). Compared with Littmann Cardiology III, auscultation quality was significantly higher with Littmann 3200 electronic stethoscope (ß = 0.9 [95% confidence interval, 0.5-1.3]). CONCLUSIONS: An electronic stethoscope can provide a better quality of pulmonary auscultation than acoustic stethoscopes in the operating room, yet with a magnitude of improvement marginally higher than that provided with a high performance acoustic stethoscope. Whether this can translate into a clinically relevant benefit requires further studies.

[Specificities of war surgery, and capacities of the military health service]. / Spécificité de la chirurgie de guerre et capacités du service de santé des armées.

In view of the recent evolution of military conflicts, particularly in the Afghan theater, and the conditions in which wounded warriors are managed in the field prior to hospitalization, the authors examine the technical specificities of medical teams, based on studies of avoidable mortality. War surgery has become a separate specialty, following the disappearance in France of the general surgical specialty, of which it was the military coun-terpart. The authors stress the role of hemorrhaging and its treatment, based on three strategies: damage control resuscitation, blood transfusion, and early evacuation within the "golden hour ". The French Armed Forces Health Service, in a new strategic plan, is refocusing its activity on war traumatology, through better education and training of medical-surgical teams and by opening up its scholarship structures to the French civilian public health service sector.

[The nurse, a key player in transfusion safety]. / L'infirmière, acteur clé de la sécurité transfusionnelle.

In the chain of transfusion safety, the nurse is the last line of defence in the battery of controls to avoid transfusion errors. The final pre-transfusion test carried out at the patient's bedside is a meticulous procedure. It involves cross-referencing documents, checking the identity of the patient and determining the ABO blood group through an agglutination test.