[Safety management and compliance with rules]. / Management des risques et respect des règles.

The design of rules (laws, norms, policies, procedures, protocols) and the implementation of a management that aimed at conforming the behaviors of operators with these rules has long been the dominant approach to improve safety in socio-technical systems. This approach has proven to be effective in enhancing safety by enabling organizations to cope with predictable risks and failures. However, in our modern and constantly evolving socio-technical systems, where the management of unforeseen situation has become the rule, this approach has shown its limitations: operators' initiatives, which sometimes deviate from rules, are equally important for maintaining safety. Therefore, while the rules remain a key feature of risk management, the challenge is not the search for total compliance with rules, but the permanent monitoring of their use to detect and distinguish gaps that constitute a drift towards the accident from gaps that highlight that the rule has become inappropriate and which the compliance with may prove dangerous for safety.

Validation of the French version of the Hospital Survey on Patient Safety Culture questionnaire.

OBJECTIVE: To assess the psychometric properties of the French version of the Hospital Survey on Patient Safety Culture questionnaire (HSOPSC) and study the hierarchical structure of the measured dimensions. DESIGN: Cross-sectional survey of the safety culture. SETTING: 18 acute care units of seven hospitals in South-western France. PARTICIPANTS: Full- and part-time healthcare providers who worked in the units. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Item responses measured with 5-point agreement or frequency scales. Data analyses A principal component analysis was used to identify the emerging components. Two structural equation modeling methods [LInear Structural RELations (LISREL) and Partial Least Square (PLS)] were used to verify the model and to study the relative importance of the dimensions. Internal consistency of the retained dimensions was studied. A test-retest was performed to assess reproducibility of the items. RESULTS: Overall response rate was 77% (n = 401). A structure in 40 items grouped in 10 dimensions was proposed. The LISREL approach showed acceptable data fit of the proposed structure. The PLS approach indicated that three dimensions had the most impact on the safety culture: 'Supervisor/manager expectations & actions promoting safety' 'Organizational learning-continuous improvement' and 'Overall perceptions of safety'. Internal consistency was above 0.70 for six dimensions. Reproducibility was considered good for four items. CONCLUSIONS: The French HSOPSC questionnaire showed acceptable psychometric properties. Classification of the dimensions should guide future development of safety culture improving action plans.

[Glucose variability in intensive care unit]. / La variabilité glycémique en réanimation.

Hyperglycemia is significantly associated with increased mortality in critically ill patients and then, strict control of blood glucose (BG) concentration is important. Lowering of BG levels with intensive insulin therapy (IIT) was recommended in order to improve patient outcomes. But recently, some recent prospective trials failed to confirm the initial data, showing conflicting results (significantly increased mortality with IIT, more hypoglycemic episodes). So there is no consensus about efficiency and safety of IIT. Significant associations between glucose variability and mortality have been confirmed by several recent studies. A difference in variability of BG control could explain why the effect of IIT varied from beneficial to harmful. Managing and decreasing this BG variability could be an important goal of BG control in critically ill patients. Clinicians have to consider definitions, physiopathology and impacts of glucose variability, in order to improve patient outcomes.

[Errors of red cell concentrates recipients: method of analysis using the adverse events notified to the hemovigilance network in 2009]. / Erreurs de destinataire de concentrés de globules rouges : méthode d'analyse à partir de déclarations d'incidents de la chaîne transfusionnelle en 2009.

CONTEXT: Among the adverse events in the blood transfusion process, transfusion to a "wrong" patient is potentially dangerous, as it can lead to an adverse reaction at least in case of ABO incompatible red cell concentrate. MATERIAL AND METHODS: The "Root Cause Analysis" working party of the National Hemovigilance Commission developed a tool to collect this type of adverse event, and tested it on a sample of 43 cases involving red cell concentrates notified between March, 2009 and February, 2010. RESULTS: One hundred and nine failures of a step in the transfusion process were observed, i.e. 2.5 failures per adverse event. Failures may occur early in the process. However, they are mainly found at the time of issuing of the blood component, and further, in the clinical ward. How the failure is eventually detected is not always described when the blood component has been fully transfused, in contrast with the cases where actual transfusion to the wrong patient has been prevented. Knowing the way of failure detection enables an objective approach of the efficacy of the numerous existing safety measures. In this sample, bedside controls (documents check as well as the use of anti-A and anti-B reagents with patient's blood and red cell concentrates) detected the failure in three cases out of 34, which were not detected before, showing an efficacy similar to the administrative control done at reception in the clinical ward. CONCLUSION: The document, set up to analyse step by step these cases of patient errors, will be used in the future to analyse all similar cases, not only with red cell concentrates, but also with platelet concentrates and fresh frozen plasma, ultimately in order to improve their prevention.

[Second wave of the French drug harmonisation programme to prevent medication errors: overall appreciation of healthcare professionals]. / Évaluation de l'impact auprès des professionnels de la mise en œuvre de la seconde vague du plan d'harmonisation de l'étiquetage des injectables.

BACKGROUND: Medication errors are a significant cause of severe healthcare-associated complications. In December 2006, the French Health Products Agency (Afssaps) has issued a protocol to harmonise labeling of injectable drugs vials. In 2007, a first change was launched for four drugs and was followed in 2008-2009 by a second wave concerning 42 active drugs. METHODS: The present study describes how healthcare professionals have perceived this change and their overall appreciation of the drug harmonisation programme. A survey using an electronic questionnaire was distributed to medical and non-medical professionals in anaesthesia and intensive care and pharmacists in a representative sample of 200 French hospitals. RESULTS: The harmonisation procedure was felt as being overall satisfactory by 53% of professionals who had responded but it was recognised that the new procedure is associated with improved readability and understanding of drug dosage. The use of colour coding was also well accepted by the personnel of clinical units. Respondents expressed significant criticisms regarding both the communication plan and the way the plan was implemented locally in hospitals. Old and new labeling coexisted in 66% of responding hospitals and many respondents described being aware of errors or near-misses that were considered related to the transition. For many important topics, pharmacists had views that were significantly different from clinicians. CONCLUSION: This national survey describing the perception of healthcare professionals regarding the new harmonisation procedure for injectable drugs highlighted some progress but also a number of deficiencies, notably regarding communication and implementation of the change in clinical units. This survey will be used by the French Health Products Agency to improve future steps of the long-lasting campaign against medication errors.

[Epidemiology of war injuries, about two conflicts: Iraq and Afghanistan]. / Type et épidémiologie des blessures de guerre, à propos de deux conflits actuels : Irak et Afghanistan.

Since March 2003, military operations in Iraq "Operation Iraqi Freedom" (OIF) and in Afghanistan "Operation Enduring Freedom" (OEF), have made many wounded and killed in action (KIA). This article proposes to highlight the specific epidemiology of combat casualties, met in these both non-conventional and asymmetric conflicts. Personal protective equipments, Kevlar helmet and body armor, proved their efficiency in changing features of war injuries. Health Force Services organized trauma care system in different levels, with three main objectives: immediate basic medical care in battalion aid station, forward surgery and early aeromedical evacuation. The Joint Theater Trauma Registry (JTTR), a war injury registry, provides medical data, analyzed from the combat theater to the military hospital in United States. This analysis concluded that during modern conflicts, most injuries are caused by explosive devices; injuries are more severe and interestingly more specifically the head region and extremities than the trunk. Hemorrhage is the first cause of death, leading to the concept of avoidable death. Specific databases focused on mechanisms and severity of injuries, diagnostic and treatment difficulties, outcomes can guide research programs to improve war injuries prevention and treatment.

Auscultation in flight: comparison of conventional and electronic stethoscopes.

OBJECTIVES: The ability to auscultate during air medical transport is compromised by high ambient-noise levels. The aim of this study was to assess the capabilities of a traditional and an electronic stethoscope (which is expected to amplify sounds and reduce ambient noise) to assess heart and breath sounds during medical transport in a Boeing C135. METHODS: We tested one model of a traditional stethoscope (3MTM Littmann Cardiology IIITM) and one model of an electronic stethoscope (3MTM Littmann Stethoscope Model 3000). We studied heart and lung auscultation during real medical evacuations aboard a medically configured C135. For each device, the quality of auscultation was described using a visual rating scale (ranging from 0 to 100 mm, 0 corresponding to "I hear nothing," 100 to "I hear perfectly"). Comparisons were accomplished using a t-test for paired values. RESULTS: A total of 36 comparative evaluations were performed. For cardiac auscultation, the value of the visual rating scale was 53 ± 24 and 85 ± 11 mm, respectively, for the traditional and electronic stethoscope (paired t-test: P = .0024). For lung sounds, quality of auscultation was estimated at 27 ± 17 mm for traditional stethoscope and 68 ± 13 for electronic stethoscope (paired t-test: P = .0003). The electronic stethoscope was considered to be better than the standard model for hearing heart and lung sounds. CONCLUSION: Flight practitioners involved in air medical evacuation in the C135 aircraft are better able to practice auscultation with this electronic stethoscope than with a traditional one.

[Understanding mistake-proofing]. / Comprendre la notion de détrompage.

The mistake-proofing concept often refers to physical devices that prevent actors from making a wrong action. In anaesthesiology, one immediately thinks to specific design of outlets for medical gases. More generally, the principle of mistake-proofing is to avoid an error, by placing knowledge in the world rather than knowledge in the head. As it often happens in risk management, healthcare has received information transfers from the industry. Computer is changing the concept of mistake-proofing, initially based on physical design, such as aerospace and automotive industry. The mistake-proofing concept may be applied to prevention, detection, and mitigation of errors. The forcing functions are a specific part of mistake-proofing: they prevent a wrong action or they force a virtuous one. Grout proposes a little shortcut to identify mistake-proofing devices: "If it is not possible to picture it in action, it is probably not a mistake-proofing device".

[Patient safety and root cause analysis]. / Sécurité des patients et analyse des causes racines.

Safety in the field of transfusion medicine has greatly improved in France. The risk of viral transmission has decreased by a factor greater than 1500 within the last 20 years. In comparison, the risk related to ABO error has decreased only by half. The reporting of critical incidents, which occur at any step of the transfusion procedure is now mandatory in France and is subject to an in-depth analysis, using methods close to that used in aviation safety. The goal of these analyses is to better understand human factors in order to implement more adequate prevention measures.

Mortality related to anaesthesia in France: analysis of deaths related to airway complications.

Death certificates from the French national mortality database for the calendar year 1999 were reviewed to analyse cases in which airway complications had contributed to peri-operative death. Respiratory deaths (and comas) found in a previous national 1978-82 French survey (1:7960; 95% CI 1:12,700 to 1:5400) were compared with the death rate found in the present one: 1:48,200 (95% CI 1:140,000 to 1:27,500). In 1999, deaths associated with failure of the breathing circuit and equipment were no longer encountered and no death was found to be related to undetected hypoxia in the recovery unit. Deaths related to difficult intubation also occurred at a lower rate than in the previous report (1:46,000; 95% CI 1:386,000 to 1:13,000) in 1978-82 vs 1:176,000 (95% CI 1:714,000 to 1:46,000) in 1999, a fourfold reduction. In most cases, there were both inadequate practice and systems failure (inappropriate communication between staff, inadequate supervision, poor organisation). This large French survey shows that deaths associated with respiratory complications during anaesthesia have been strikingly reduced during this 15-year period.

[Survey of anaesthesia-related mortality in France: the role of aspiration of gastric contents]. / Enquête mortalité Sfar-Inserm: analyse secondaire des décès par inhalation de liquide gastrique.

Aspiration of gastric contents is a major complication in relation with the practice of anaesthesia. The present article is aimed at describing detailed data related to aspiration which were obtained during the French national survey on anaesthesia-related mortality conducted by both Sfar and CépiDC-Inserm. Information regarding methods of the survey and the main results has been previously published. In brief, the first part of the survey described the number and characteristics of anaesthetic procedures performed in 1996 (denominator). The second survey analysed deaths related to anaesthesia which were identified from death certificates of the calendar year 1999. Because of the numerical importance of aspiration among the causes of deaths, a secondary analysis was undertaken to assess into details factors leading to the occurrence of this complication. Eighty-three cases of death were found related to aspiration, i.e. one-fifth of deaths related completely or partially to anaesthesia, implying a death rate of one for 221,368 general anaesthetic procedures or 4.5 x 10(-6) (95% IC: 0.8 x 10(-6)-14 x 10(-6)). Patients involved were all in a severe clinical condition (ASA> or =3: 92%), very old and often scheduled for urgent abdominal surgery. Two cases of death occurred during colonoscopy but none in obstetric patients. Aspiration almost always occurred during induction of anaesthesia. Analysis of practice patterns disclosed significant deviations from recommendations. French anaesthetists should voluntarily move through a personal and active process toward an improvement of their practice to reduce the incidence of aspiration.