LEARNING FROM NEAR MISSES IN MEDICATION ERRORS: A BAYESIAN APPROACH

Medical errors originating in health care facilities are a significant source of preventable morbidity, mortality, and healthcare costs. Voluntary error report systems that collect information on the causes and contributing factors of medi- cal errors regardless of the resulting harm may be useful for developing effective harm prevention strategies. Some patient safety experts question the utility of data from errors that did not lead to harm to the patient, also called near misses. A near miss (a.k.a. close call) is an unplanned event that did not result in injury to the patient. Only a fortunate break in the chain of events prevented injury. We use data from a large voluntary reporting system of 836,174 medication errors from 1999 to 2005 to provide evidence that the causes and contributing factors of errors that result in harm are similar to the causes and contributing factors of near misses. We develop Bayesian hierarchical models for estimating the log odds of selecting a given cause (or contributing factor) of error given harm has occurred and the log odds of selecting the same cause given that harm did not occur. The posterior distribution of the correlation between these two vectors of log-odds is used as a measure of the evidence supporting the use of data from near misses and their causes and contributing factors to prevent medical errors. In addition, we identify the causes and contributing factors that have the highest or lowest log-odds ratio of harm versus no harm. These causes and contributing factors should also be a focus in the design of prevention strategies. This paper provides important evidence on the utility of data from near misses, which constitute the vast majority of errors in our data.

Near miss materno e iniquidades em saúde: análise de determinantes contextuais no Rio Grande do Norte, Brasil

The scope of this study was to identify socioeconomic contextual and health care factors in primary care associated with maternal near misses and their marker conditions. This is an ecological study that used aggregated data of 63 clusters formed by the municipalities of State of Rio Grande do Norte, Brazil, using the Skater method of area regionalization, as the unit of analysis. The ratio of maternal near misses and their marker conditions were obtained from the Hospital Information System of the Brazilian Unified Health System. In multiple linear regression analysis, there was a significant association between maternal near misses and variables of poverty and poor primary health care. Hypertensive disorders were also associated with poverty and poor primary care and the occurrence of hemorrhaging was associated with infant mortality. It was observed that the occurrence of maternal near misses is linked to unfavorable socioeconomic conditions and poor quality health care that are a reflection of public policies that accentuate health inequalities.

Near miss materno e iniquidades em saúde: análise de determinantes contextuais no Rio Grande do Norte, Brasil

The scope of this study was to identify socioeconomic contextual and health care factors in primary care associated with maternal near misses and their marker conditions. This is an ecological study that used aggregated data of 63 clusters formed by the municipalities of State of Rio Grande do Norte, Brazil, using the Skater method of area regionalization, as the unit of analysis. The ratio of maternal near misses and their marker conditions were obtained from the Hospital Information System of the Brazilian Unified Health System. In multiple linear regression analysis, there was a significant association between maternal near misses and variables of poverty and poor primary health care. Hypertensive disorders were also associated with poverty and poor primary care and the occurrence of hemorrhaging was associated with infant mortality. It was observed that the occurrence of maternal near misses is linked to unfavorable socioeconomic conditions and poor quality health care that are a reflection of public policies that accentuate health inequalities.

Prevalência e fatores associados ao Near Miss Materno: inquérito populacional em uma capital do Nordeste Brasileiro

The scope of this study was to determine the prevalence of near misses and complications during pregnancy and the puerperal period, identifying the main clinical and intervention markers and socioeconomic and demographic factors associated with near misses. It involved a cross-sectional, population-based and probabilistic study with multi-stage complex sampling design conducted in Natal, State of Rio Grande do Norte, Brazil. A validated questionnaire was given to 848 women aged 15 to 49 identified in 8,227 households in 60 census sectors. In theanalysis of associations, the Chi-square test applied and calculated the prevalence ratio (PR) with Confidence Interval (CI) of 95% and 5% significance. The prevalence of maternal near misses was 41.1/1000LB, with hospitalization in an Intensive Care Unit (19.1/1000LB) and eclampsia (13.5/1000LB) being the most important markers. The prevalence of complications during pregnancy and the puerperal period was 21.2%. The highest prevalence of near misses was observed in older women, of black/brown race and low socioeconomic status. Conducting population surveys is feasible and may add important information to the study of near misses and the markers highlight the need for enhancing maternal care to reduce health inequality.

Prevalência e fatores associados ao Near Miss Materno: inquérito populacional em uma capital do Nordeste Brasileiro

The scope of this study was to determine the prevalence of near misses and complications during pregnancy and the puerperal period, identifying the main clinical and intervention markers and socioeconomic and demographic factors associated with near misses. It involved a cross-sectional, population-based and probabilistic study with multi-stage complex sampling design conducted in Natal, State of Rio Grande do Norte, Brazil. A validated questionnaire was given to 848 women aged 15 to 49 identified in 8,227 households in 60 census sectors. In theanalysis of associations, the Chi-square test applied and calculated the prevalence ratio (PR) with Confidence Interval (CI) of 95% and 5% significance. The prevalence of maternal near misses was 41.1/1000LB, with hospitalization in an Intensive Care Unit (19.1/1000LB) and eclampsia (13.5/1000LB) being the most important markers. The prevalence of complications during pregnancy and the puerperal period was 21.2%. The highest prevalence of near misses was observed in older women, of black/brown race and low socioeconomic status. Conducting population surveys is feasible and may add important information to the study of near misses and the markers highlight the need for enhancing maternal care to reduce health inequality.

L'erreur en médecine ambulatoire: comment l'aborder. [Error in ambulatory medicine: how to deal with it?]

Medical errors compromise patient safety in ambulatory practice. These errors must be faced in a framework that reduces to a minimum their consequences for the patients. This approach relies on the implementation of a new culture without stigmatization and where errors are disclosed to the patients; this culture implies the build up of a system for reporting errors associated to an in-depth analysis of the system, looking for root causes and insufficient barriers with the aim to fix them. A useful education tool is the "critical situations" meeting during which physicians are encouraged to openly present adverse events and "near misses". Their analysis, with supportive attitude towards involved staff members, allows to reveal systems failures within the institution or the private practice.

Effectiveness of Pilotage

The objective of the pilotage effectiveness study was to come up with a process descrip-tion of the pilotage procedure, to design performance indicators based on this process description, to be used by Finnpilot, and to work out a preliminary plan for the imple-mentation of the indicators within the Finnpilot organisation. The theoretical aspects of pilotage as well as the guidelines and standards used were determined through a literature review. Based on the literature review, a process flow model with the following phases was created: the planning of pilotage, the start of pilo-tage, the act of pilotage, the end of pilotage and the closing of pilotage. The model based on the literature review was tested through interviews and observation of pilotage. At the same time an e-mail survey directed at foreign pilotage organisations, which included a questionnaire concerning their standards and management systems, operations procedures, measurement tools and their attitude to the passage planning, was conducted. The main issues in the observations and interviews were the passage plan and the bridge team co-operation. The phases of the pilotage process model emerged in both the pilotage activities and the interviews whereas bridge team co-operation was relatively marginal. Most of the pilotage organisations, who responded to the query, also use some standard-based management system. All organisations who answered the survey use some sort of a pilotage process model. According to the query, the main measuring tools for pilotage are statistical information concerning pilotage and the organisations, the customer feedback surveys, and financial results. Attitudes to-wards passage planning were mostly positive among the organisations. A workshop with pilotage experts was arranged where the process model constructed on the basis of the literature review was tuned to match practical pilotage. In the workshop it was determined that certain phases and the corresponding tasks, through which pilo-tage can be described as a process, were identifiable in all pilotage. The result of the workshop was a complemented process model, which separates incoming and outgoing traffic, as well as the fairway pilotage and harbour pilotage from each other. Addition-ally indicators divided according to the data gathering method were defined. Data con-cerning safety and traffic flow is gathered in the form of customer feedback. The pilot's own perceptions of the pilotage process are gathered through self-assessment. The measurement data which is connected to the phases of the pilotage process is generated e.g. by gathering statistics of the success of the pilot dispatches, the accuracy of the pi-lotage and the incidents that occurred during the pilotage, near misses, deviations and accidents. The measurement data is collected via the PilotWeb at the closing of the pilo-tage. A separate project and a project group with pilots also participating will be established for the deployment of the performance indicators. The phases of the project are: the definition phase, the implementation phase and the deployment phase. The purpose of the definition phase is to prepare questions for ship commanders concerning the cus-tomer feedback questionnaire and also to work out the self-assessment queries and the queries concerning the process indicators.

Indicent reporting in shipping. Experiences and best practices for the Baltic Sea

Incident and near miss reporting is one of the proactive tools of safety management. By analyzing incidents and near misses and by corrective actions, severe accidents can potentially be avoided. Near miss and incident reporting is widely used in many riskprone industries such as aviation or chemical industry. In shipping incident and near miss reporting is required by the mandatory safety management system International Safety Management Code (ISM Code). However, in several studies the conclusion has been that incidents are reported poorly in the shipping industry. The aim of this report is to highlight the best practices for incident reporting in shipping and to support the shipping industry in the better utilization of incident reporting information. The study consists of three parts: 1) voluntary, shared reporting systems in shipping (international experiences), 2) interview study at four shipping companies in Sweden and in Finland (best practices), 3) expert workshop on incident reporting (problems and solutions). Preconditions for a functional reporting system are an existing no blame culture, commitment of the top management, feedback, good communication, training and an easy-to-use system. Although preconditions are met, problems can still appear, for example due to psychological, interpersonal or nationality-related reasons. In order to keep the reporting system functioning, the shipping company must be committed to maintain and develop the system and to tackle the problems. The whole reporting process from compiling, handling and analyzing a report, creating corrective actions and implementing them has to be handled properly in order to gain benefits from the reporting system. In addition to avoiding accidents, the functional reporting system can also offer other benefits by increasing safety awareness, by improving the overall safety and working conditions onboard, by enhancing team work and communication onboard and between ships and the land-based organization of shipping companies. Voluntary shared reporting systems are supported in the shipping industry in principle, but their development in the Baltic Sea is still in its infancy and the potential benefits of sharing the reports have not been realized. On the basis of this study we recommend that a common reporting system be developed for the Baltic Sea area which all the ships operating in the area could use regardless of their flag. Such a wider system could prevent some of the problems related to the current national systems. There would be more incident cases available in the database and this would support anonymity and thus encourage shipping companies to report to a shared database more frequently. A shared reporting system would contribute to the sharing of experiences and to the wider use of incident information in the shipping industry.

Factores de riesgo para morbilidad materna extrema en gestantes

Introducción: La morbilidad materna extrema es un término usado para definir cualquier condición obstétrica severa que amenaza la vida y requiere una intervención médica urgente con el fin de prevenir la probable muerte materna. Con el presente estudio se pretendió evaluar los factores de riesgo para morbilidad materna extrema en las gestantes del Hospital Universitario Mayor. Metodología Se realizó un estudio de casos y controles, comparando pacientes con MME y sin MME en una relación de 1:1. Se realizó un muestreo aleatorio simple teniendo en cuenta 95% de la población apareadas por diagnóstico de ingreso. Resultados Se incluyeron un total de 110 pacientes (55 en cada grupo). Ambas poblaciones fueron comprables. Ser de estrato socioeconómico bajo (p 0,000), haber tenido 2 o menos partos (p 0,000), ser tipo de sangre negativo (p0.000) realizar entre 0-3 controles prenatales (p 0,000), tener antecedente de preeclampsia (p 0,000), hipotiroidismo (p 0,000), o trastorno bipolar (p 0,000), son factores de riesgo significativos para presentar MME. Entre los factores protectores están tener más de tres partos OR 0,60 (IC95%: 0,17-0,82, p=0,00) y 7 o más controles prenatales OR 0,23 (IC95%: 0,09-0,55, p=0,000). Resultados concordantes con la literatura Discusión: Es importante dar a conocer los resultados del presente estudio para promover las campañas de prevención primaria, secundaria y terciaria con el fin de evitar las altas complicaciones que se pueden presentar en las mujeres en edad fértil de nuestra población.

Errors associated with the preparation of aseptic products in UK hospital pharmacies: lessons from the national aseptic error reporting scheme

Background Pharmacy aseptic units prepare and supply injectables to minimise risks. The UK National Aseptic Error Reporting Scheme has been collecting data on pharmacy compounding errors, including near-misses, since 2003. Objectives The cumulative reports from January 2004 to December 2007, inclusive, were analysed. Methods The different variables of product types, error types, staff making and detecting errors, stage errors detected, perceived contributory factors, and potential or actual outcomes were presented by cross-tabulation of data. Results A total of 4691 reports were submitted against an estimated 958 532 items made, returning 0.49% as the overall error rate. Most of the errors were detected before reaching patients, with only 24 detected during or after administration. The highest number of reports related to adult cytotoxic preparations (40%) and the most frequently recorded error was a labelling error (34.2%). Errors were mostly detected at first check in assembly area (46.6%). Individual staff error contributed most (78.1%) to overall errors, while errors with paediatric parenteral nutrition appeared to be blamed on low staff levels more than other products were. The majority of errors (68.6%) had no potential patient outcomes attached, while it appeared that paediatric cytotoxic products and paediatric parenteral nutrition were associated with greater levels of perceived patient harm. Conclusions The majority of reports were related to near-misses, and this study highlights scope for examining current arrangements for checking and releasing products, certainly for paediatric cytotoxic and paediatric parenteral nutrition preparations within aseptic units, but in the context of resource and capacity constraints.

Análise dos fatores intervenientes na ocorrência de quase-acidentes: um estudo de caso em uma equipe do departamento de logística de uma indústria química

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Mortalidade Materna: uma abordagem atualizada

Purpose: to review literature, highlighting current aspects of maternal mortality.  Method: research initiated through electronic data base PubMed [http:// www.ncbi.nlm.nih.gov/pubmed], limited to the last 10 years. The selected cases which related to pre-defined aspects of interest to the study, such as vulnerable population, risk factors, causes, difficulties in obtaining data, preventive measures e new approaches to the problem, among them, ‘near misses’ and severe maternal morbidity.  Results: maternal death is directly related to the quality of life of the population, with relevant disparities among the different social economic areas. Although maternal mortality is the proper indicator to the female population health, its numbers are presented in unrealistic manners due to the difficulties in identifying the cases through death certificates. Preventive measures associated to early and adequate diagnose and treatment are benefic factors in decreasing those maternal deaths. Apart from these, identification and classification of ‘near misses’ and maternal morbidity are featured in the contemporary approach to the issue.  Final considerations: In spite of advanced technology and recognition of preventive measures, a large number of women die daily due to complications in the pregnancy and puerperal cycle. To decrease such tragedy political, social and economical commitment to Health is necessary, in order to promote the needed reforms in the assistance of such cycle.

Development of advanced tools and methods for the assessment and management of risk due to atypical major accident scenarios

Proper hazard identification has become progressively more difficult to achieve, as witnessed by several major accidents that took place in Europe, such as the Ammonium Nitrate explosion at Toulouse (2001) and the vapour cloud explosion at Buncefield (2005), whose accident scenarios were not considered by their site safety case. Furthermore, the rapid renewal in the industrial technology has brought about the need to upgrade hazard identification methodologies. Accident scenarios of emerging technologies, which are not still properly identified, may remain unidentified until they take place for the first time. The consideration of atypical scenarios deviating from normal expectations of unwanted events or worst case reference scenarios is thus extremely challenging. A specific method named Dynamic Procedure for Atypical Scenarios Identification (DyPASI) was developed as a complementary tool to bow-tie identification techniques. The main aim of the methodology is to provide an easier but comprehensive hazard identification of the industrial process analysed, by systematizing information from early signals of risk related to past events, near misses and inherent studies. DyPASI was validated on the two examples of new and emerging technologies: Liquefied Natural Gas regasification and Carbon Capture and Storage. The study broadened the knowledge on the related emerging risks and, at the same time, demonstrated that DyPASI is a valuable tool to obtain a complete and updated overview of potential hazards. Moreover, in order to tackle underlying accident causes of atypical events, three methods for the development of early warning indicators were assessed: the Resilience-based Early Warning Indicator (REWI) method, the Dual Assurance method and the Emerging Risk Key Performance Indicator method. REWI was found to be the most complementary and effective of the three, demonstrating that its synergy with DyPASI would be an adequate strategy to improve hazard identification methodologies towards the capture of atypical accident scenarios.

Critical incidence reporting systems - an option in equine anaesthesia? Results from a panel meeting.

OBJECTIVE To provide a brief introduction into Critical Incident Reporting Systems (CIRS) as used in human medicine, and to report the discussion from a recent panel meeting discussion with 23 equine anaesthetists in preparation for a new CEPEF-4 (Confidential Enquiry into Perioperative Equine Fatalities) study. STUDY DESIGN Moderated group discussions, and review of literature. METHODS The first group discussion focused on the definition of 'preventable critical incidents' and/or 'near misses' in the context of equine anaesthesia. The second group discussion focused on categorizing critical incidents according to an established framework for analysing risk and safety in clinical medicine. RESULTS While critical incidents do occur in equine anaesthesia, no critical incident reporting system including systematic collection and analysis of critical incidents is in place. CONCLUSIONS AND CLINICAL RELEVANCE Critical incident reporting systems could be used to improve safety in equine anaesthesia - in addition to other study types such as mortality studies.

Outpatient Parenteral Antimicrobial Therapy Practices among Adult Infectious Disease Physicians

Objective. To identify current outpatient parenteral antibiotic therapy practice patterns and complications. Methods. We administered an 11-question survey to adult infectious disease physicians participating in the Emerging Infections Network (EIN), a Centers for Disease Control and Prevention-sponsored sentinel event surveillance network in North America. The survey was distributed electronically or via facsimile in November and December 2012. Respondent demographic characteristics were obtained from EIN enrollment data. Results. Overall, 555 (44.6%) of EIN members responded to the survey, with 450 (81%) indicating that they treated 1 or more patients with outpatient parenteral antimicrobial therapy (OPAT) during an average month. Infectious diseases consultation was reported to be required for a patient to be discharged with OPAT by 99 respondents (22%). Inpatient (282 [63%] of 449) and outpatient (232 [52%] of 449) infectious diseases physicians were frequently identified as being responsible for monitoring laboratory results. Only 26% (118 of 448) had dedicated OPAT teams at their clinical site. Few infectious diseases physicians have systems to track errors, adverse events, or "near misses" associated with OPAT (97 [22%] of 449). OPAT-associated complications were perceived to be rare. Among respondents, 80% reported line occlusion or clotting as the most common complication (occurring in 6% of patients or more), followed by nephrotoxicity and rash (each reported by 61%). Weekly laboratory monitoring of patients who received vancomycin was reported by 77% of respondents (343 of 445), whereas 19% of respondents (84 of 445) reported twice weekly laboratory monitoring for these patients. Conclusions. Although use of OPAT is common, there is significant variation in practice patterns. More uniform OPAT practices may enhance patient safety.