Prevalence, characteristics, and impact of Adverse Events in 34 Madrid hospitals. The ESHMAD study.

INTRODUCTION: Adverse Events (AE) are one of the main problems in healthcare. Therefore, many policies have been developed worldwide to mitigate their impact. The Patient Safety Incident Study in Hospitals in the Community of Madrid (ESHMAD) measures the results of them in the region. METHODS: Cross-sectional study, conducted in May 2019, in hospitalised patients in 34 public hospitals using the Harvard Medical Practice Study methodology. A logistic regression model was carried out to study the association of the variables with the presence of AE, calibrated and adjusted by patient. RESULTS: A total of 9,975 patients were included, estimating a prevalence of AE of 11.9%. A higher risk of AE was observed in patients with surgical procedures (OR[CI95%]: 2.15[1.79 to 2.57], vs. absence), in Intensive Care Units (OR[CI95%]: 1.60[1.17 to 2.17], vs. Medical), and in hospitals of medium complexity (OR[CI95%]: 1.45[1.12 to 1.87], vs. low complexity). A 62.6% of AE increased the length of the stay or it was the cause of admission, and 46.9% of AE were considered preventable. In 11.5% of patients with AE, they had contributed to their death. CONCLUSIONS: The prevalence of AE remains similar to the previously estimated in studies developed with the same methodology. AE keep leading to longer hospital stays, contributing to patient's death, showing that it is necessary to put focus on patient safety again. A detailed analysis of these events has enabled the detection of specific areas for improvement according to the type of care, centre, and patient.

[Impact of the COVID-19 pandemic on patient safety incident and medication error reporting systems]. / Impacto de la pandemia COVID-19 en los sistemas de notificación de incidentes de seguridad del paciente y errores de medicación.

BACKGROUND AND AIM: To determine the impact of the COVID-19 pandemic on the epidemiology of safety incidents (SI) and medication errors (ME) reported to the CISEMadrid notification system in the hospital and primary care settings of the Madrid Health Service (SERMAS). MATERIALS AND METHODS: Observational and descriptive study with a retrospective analysis of data including all CISEMadrid notifications from 01-Jan-2018 to 31-Dec-2020, from 33 hospitals and 262 health care centres of the SERMAS. The two periods in 2020 with the greatest increase in COVID-19 cases were identified to compare incidents reported in the pre-pandemic and pandemic periods. RESULTS: 36,494 incidents were reported. Comparing both periods, an overall decrease in pandemic notifications of 60.7% was observed, being higher in primary care, falling to 33% of previous levels. The reduction in notifications was similar in the peaks and valleys of the waves. The three most frequent SIs in both periods and care settings were: diagnostic tests, medical devices/equipment/clinical furniture and organisational management/citations. In ME, dose failure and inappropriate selection were the most frequent in both settings and periods. There were no relevant differences in patient consequences in both periods. CONCLUSIONS: During the pandemic, patient safety notifications decreased although the most frequent types remained the same, as did their impact on the patient, both in hospitals and in primary care. The safety culture of organisations is a critical aspect for the maintenance of reporting systems.

The Study on Safety in Hospitals in the Region of Madrid (ESHMAD) design: Screening and analysis of incidents and adverse events.

BACKGROUND: A Study related to Safety in Hospitals in the Region of Madrid (ESHMAD) was carried out in order to determine the prevalence, magnitude and characteristics of adverse events in public hospitals. This work aims to define a useful methodology for the multicenter study of adverse events in the Region of Madrid, to set out the preliminary results of the hospital enrollment and to establish a model of a strategy of training of trainers for its implementation. METHODS: ESHMAD was a multicenter, double phase study for the estimation of adverse events and incidents prevalence across the Region of Madrid. First phase comprehended a 1-day cross-sectional prevalence study, in which it was collected, through a screening guide, information about admission, patient characteristics, intrinsic and extrinsic risk factors, and the possibility of an adverse event or incident had happened during the hospitalization. Second phase was a retrospective nested cohort study, in which it was used a Modular Review Form for reviewing the positive screenings of the first phase, identifying in each possible adverse event or incident the classification of the patient safety event, clinical onset, root, and associated causes and factors, impact, and preventability. A pilot study was performed in an Internal Medicine Unit of a tertiary hospital. RESULTS: 34 public hospitals participated, belonging to 6 healthcare categories and with more than 10,000 hospitalisations aggregate capacity. 72 coordinators were enrolled in the strategy of training of trainers, which was performed through five on-site training workshops. In the pilot study, 45.2% patients were identified with at least one positive event of the screening. Of them, 48.1% (25 positive events) were identified as truly AE, with a result of 0.29 EA per analyzed patient. CONCLUSIONS: The ESHMAD protocol allows to estimate the prevalence of adverse events, and the strategy of training of trainers facilitated the spread of the research methodology among the participants.

[EFQM Model in the hospitals of Madrid Regional Health Service: full self-assessment cycle]. / Modelo EFQM en los hospitales del Servicio Madrileño de Salud: ciclo completo de autoevaluación.

AIM: To analyse a complete cycle of self-assessment using the European Foundation for Quality Management (EFQM) Model in the hospitals of the Madrid Health Service as regards the fundamental concepts of excellence (FCE). METHOD: Descriptive study of the EFQM self-assessments of the entire public hospital sector identifying the methodology and the information on strengths, weaknesses, evidence, RADAR matrix (Results, Approach, Deployment, Assessment and Review), and the related FCEs in the enabling criteria and in the prioritised action plans. RESULTS: The self-assessment was carried out in 85% of the hospitals (29/34), 86% of them required specific training (25/29), with a total of 329 teaching hours and 833 people in training. Multidisciplinary working groups were required in 83% of the hospitals (24/29), with 123 groups and 857 people involved. There were 3,686 strengths and 3,197 weaknesses identified: strengths and weaknesses were 78% (2,869) and 74% (2,355), respectively, for the enabling criteria and 22% (817) and 26% (842), respectively, for the results criteria. The mean score was 404 points with a median of 399. The main FCEs were managing with agility, developing organisational capability, sustaining outstanding results, creating a sustainable future, succeeding through the talent of people, and adding value for customers, with harnessing creativity/innovation and leading with vision, inspiration and integrity being placed in lower positions. A total of 113 action plans were identified for all the hospitals. CONCLUSION: A complete EFQM self-assessment cycle of the entire public hospital sector of a Regional Health Service is provided, linking the analysis and action plans with the FCE of the EFQM Model.

Barreras y retos de las unidades funcionales de gestión de riesgos sanitarios en los hospitales del Servicio Madrileño de Salud / Barriers and challenges of the functional healthcare risk management units in hospitals of Madrid health service

Objetivo. Identificar las barreras y los retos para el desarrollo efectivo de las unidades de gestión de riesgos sanitarios en los hospitales del Servicio Madrileño de Salud. Material y métodos. Estudio descriptivo transversal dirigido a los equipos directivos y a los miembros de las unidades funcionales de 31 hospitales del Servicio Madrileño de Salud. Se solicitó en forma de texto libre, dentro de un cuestionario autoadministrado, la identificación de un máximo de 5 barreras y retos y su priorización a través de la adjudicación de uno a 5 puntos de acuerdo con su importancia. Posteriormente se realizó un análisis del discurso agrupando los temas comunes y ordenándolos de acuerdo con la puntuación recibida. Resultados. La tasa de respuesta global fue del 94%. Las barreras más frecuentemente identificadas fueron: falta de tiempo (21%), insuficiente cultura de seguridad (13%), escasa difusión de sus actividades (10%) y falta de formación (10%). El reto más importante fue potenciar la formación (18%), seguido de mejorar la cultura (17%), difundir las actividades de seguridad (11%) y lograr el liderazgo de los responsables de los servicios (11%). Conclusiones. En las condiciones del estudio, la barrera fundamental identificada fue la falta de tiempo y el reto principal la necesidad de formación. Por ello parece necesario mejorar el apoyo organizativo a la seguridad clínica en el ámbito objeto de estudio (AU)

Objective. To identify the barriers and challenges for the effective development of risk management units in hospitals of the Madrid Health Service Material and methods. Descriptive cross-sectional study aimed at the management teams and members of the functional units of 31 hospitals in the Madrid Health Service. A self-administered questionnaire requesting answers in free text was used, identifying up to five barriers and challenges, and their prioritization by awarding from 1-5 points according to their importance. A discourse analysis was then conducted, grouping common themes and sorting them according to their score. Results. The overall response rate was 94%. The most frequently identified barriers were lack of time (21%), inadequate safety culture (13%), lack of publication of their activities (10%), and lack of training (10%). The most important challenge was developing the training (18%), followed by improving the culture (17%), communication of safety activities (11%), and achieve leadership from the managers of the services (11%). Conclusions. According to the study conditions, the main identified barrier identified was the lack of available time, and the principal challenge found was promoting a proactive learning culture (AU)

[Barriers and challenges of the functional healthcare risk management units in hospitals of Madrid health service]. / Barreras y retos de las unidades funcionales de gestión de riesgos sanitarios en los hospitales del Servicio Madrileño de Salud.

OBJECTIVE: To identify the barriers and challenges for the effective development of risk management units in hospitals of the Madrid Health Service. MATERIAL AND METHODS: Descriptive cross-sectional study aimed at the management teams and members of the functional units of 31 hospitals in the Madrid Health Service. A self-administered questionnaire requesting answers in free text was used, identifying up to five barriers and challenges, and their prioritization by awarding from 1-5 points according to their importance. A discourse analysis was then conducted, grouping common themes and sorting them according to their score. RESULTS: The overall response rate was 94%. The most frequently identified barriers were lack of time (21%), inadequate safety culture (13%), lack of publication of their activities (10%), and lack of training (10%). The most important challenge was developing the training (18%), followed by improving the culture (17%), communication of safety activities (11%), and achieve leadership from the managers of the services (11%). CONCLUSIONS: According to the study conditions, the main identified barrier identified was the lack of available time, and the principal challenge found was promoting a proactive learning culture.

Conferencia de consenso sobre información de eventos adversos a pacientes y familiares / Consensus conference on providing information of adverse events to patients and relatives

Objetivo. Elaborar unas recomendaciones sobre «Información de eventos adversos a pacientes y familiares», mediante la realización de una conferencia de consenso. Material y métodos. Se realizó una revisión bibliográfica de la evidencia disponible, de las principales publicaciones de políticas y guías internacionales y la legislación específica desarrollada en algunos países sobre dicho proceso. La revisión bibliográfica constituyó la base para dar respuesta a una serie de preguntas planteadas en una sesión pública. Un grupo de expertos presentaron la mejor evidencia disponible interaccionando con las partes interesadas. Al término de la sesión un jurado, interdisciplinario y multiprofesional, estableció las recomendaciones finales de la conferencia de consenso. Resultados. Las principales recomendaciones abogan por el interés de elaborar políticas y guías institucionales en nuestro ámbito que favorezcan el proceso de información sobre eventos adversos a los pacientes. Se destaca la necesidad de formación de los profesionales en habilidades de comunicación y en seguridad del paciente, así como el desarrollo de estrategias de soporte a los profesionales que se ven implicados en un evento adverso. Se considera evaluar el interés e impacto de legislación específica que ayudará a la implantación de dichas políticas. Conclusiones. Es necesario un cambio cultural a todos los niveles, matizado y adaptado a las circunstancias específicas sociales y culturales de nuestro ámbito social y sanitario, e implicar a todos los actores del sistema para crear un marco de confianza y credibilidad en el que pueda hacerse efectivo el proceso de información sobre eventos adversos (AU)

Objective: To develop recommendations regarding «Information about adverse events to patients and their families», through the implementation of a consensus conference. Material and methods: A literature review was conducted to identify all relevant articles, the major policies and international guidelines, and the specific legislation developed in some countries on this process. The literature review was the basis for responding to a series of questions posed in a public session. A group of experts presented the best available evidence, interacting with stakeholders. At the end of the session, an interdisciplinary and multi-professional jury established the final recommendations of the consensus conference. Results: The main recommendations advocate the need to develop policies and institutional guidelines in our field, favouring the patient adverse events disclosure process. The recommendations emphasize the need for the training of professionals in communication skills and patient safety, as well as the development of strategies for supporting professionals who are involved in an adverse event. The assessment of the interest and impact of specific legislation that would help the implementation of these policies was also considered. Conclusions: A cultural change is needed at all levels, nuanced and adapted to the specific social and cultural aspects of our social and health spheres, and involves all stakeholders in the system to create a framework of trust and credibility in which the processing of information about adverse events may become effective (AU)

[Consensus conference on providing information of adverse events to patients and relatives]. / Conferencia de consenso sobre información de eventos adversos a pacientes y familiares.

OBJECTIVE: To develop recommendations regarding «Information about adverse events to patients and their families¼, through the implementation of a consensus conference. MATERIAL AND METHODS: A literature review was conducted to identify all relevant articles, the major policies and international guidelines, and the specific legislation developed in some countries on this process. The literature review was the basis for responding to a series of questions posed in a public session. A group of experts presented the best available evidence, interacting with stakeholders. At the end of the session, an interdisciplinary and multi-professional jury established the final recommendations of the consensus conference. RESULTS: The main recommendations advocate the need to develop policies and institutional guidelines in our field, favouring the patient adverse events disclosure process. The recommendations emphasize the need for the training of professionals in communication skills and patient safety, as well as the development of strategies for supporting professionals who are involved in an adverse event. The assessment of the interest and impact of specific legislation that would help the implementation of these policies was also considered. CONCLUSIONS: A cultural change is needed at all levels, nuanced and adapted to the specific social and cultural aspects of our social and health spheres, and involves all stakeholders in the system to create a framework of trust and credibility in which the processing of information about adverse events may become effective.

Evaluación del sistema de información de seguridad del paciente de los centros sanitarios del Servicio Madrileño de Salud (Atención Primaria y Hospitales) / Assessment of Patient Safety reporting system in Madrid Health Services (Primary Care and Hospitals)

Objetivos. Mejorar el sistema de información de seguridad del paciente de las unidades funcionales de gestión de riesgos sanitarios (UFGRS) de los centros del Servicio Madrileño de Salud; analizando la opinión de las UFGRS sobre el contenido, cumplimentación y utilidad, detectando las dificultades e identificando las áreas de mejora. Método. Se ha realizado un estudio descriptivo mediante cuestionarios dirigidos a las 45 UFGRS de los centros sanitarios del Servicio Madrileño de Salud. Resultados. El cuestionario, en una escala de 1 a 5, obtuvo respuestas en promedios superiores a 3,70 en: los contenidos (3,77), la forma de cumplimentar (3,72) el formulario; la claridad en la exposición de los datos del informe (3,94) y en la utilidad global de la información (3,77). Las dificultades detectadas más significativas estaban relacionadas con el exceso y reiteración de información solicitada. En las áreas de mejora destacan la demanda de mayor depuración y análisis de información sobre prácticas seguras, la realización de dos formatos de informe de resultados para facilitar la difusión en los centros y la revisión de la clasificación de incidentes de seguridad. Conocer la opinión de las unidades funcionales sobre el sistema de información permite mejorar la utilidad del mismo en cuanto a la accesibilidad, presentación e intercambio de la información en materia de seguridad del paciente(AU)

Objectives. Improve the patient safety reporting system of the Functional Units of Health Risk Management (UFGRS) in Madrid health services, analysing the opinion of the UFGRS about its content, completion and usefulness, detecting the difficulties and identifying the areas for improvement. Method. A descriptive study was conducted using a questionnaire addressed to the 45 UFGRS of the Madrid Health Services. Results. The questionnaire, with a scale of 1 to 5, received responses with an average higher than 3.70: contents (3.77); how to complete the form (3.72); clarity of data shown in the report (3.94) and the overall usefulness of the information (3.77). The most significant difficulties found were related to the excess and reiteration of the information requested. As regards areas for improvement, the most notable was the demand for more refining and analysis of the information about safe practices, the execution of two types of format for reporting results in order to facilitate dissemination among the centres and the review of the classification of safety incidents. Knowing the opinion of the Functional Units of the information system may improve the usefulness of the report as far as accessibility, presentation and exchange of information on patient safety is concerned(AU)

[Assessment of patient safety reporting system in Madrid health services (primary care and hospitals)]. / Evaluación del sistema de información de seguridad del paciente de los centros sanitarios del Servicio Madrileño de Salud (Atención Primaria y Hospitales).

OBJECTIVES: Improve the patient safety reporting system of the Functional Units of Health Risk Management (UFGRS) in Madrid health services, analysing the opinion of the UFGRS about its content, completion and usefulness, detecting the difficulties and identifying the areas for improvement. METHOD: A descriptive study was conducted using a questionnaire addressed to the 45 UFGRS of the Madrid Health Services. RESULTS: The questionnaire, with a scale of 1 to 5, received responses with an average higher than 3.70: contents (3.77); how to complete the form (3.72); clarity of data shown in the report (3.94) and the overall usefulness of the information (3.77). The most significant difficulties found were related to the excess and reiteration of the information requested. As regards areas for improvement, the most notable was the demand for more refining and analysis of the information about safe practices, the execution of two types of format for reporting results in order to facilitate dissemination among the centres and the review of the classification of safety incidents. Knowing the opinion of the Functional Units of the information system may improve the usefulness of the report as far as accessibility, presentation and exchange of information on patient safety is concerned.

Utilización de los ejes transversales del modelo EFQM en el ámbito sanitario público / Use of the EFQM Red Threads in the Health Public Health System

Objetivo: Analizar la utilización de los ejes transversales (EETT) del modelo EFQM en la autoevaluación de las organizaciones de servicios en una comunidad autónoma, y describir el resultado de la autoevaluación para el conjunto del sistema sanitario público (SSP). Material y métodos: Estudio descriptivo en dos etapas: 1) evaluación del uso del modelo EFQM en el SSP, y 2) análisis de la metodología de trabajo mediante EETT. En la primera fase se analizó el 100% de los informes de autoevaluación (37 gerencias) de Atención Primaria (AP) y Especializada (AE) (2007). Se realizó un análisis cuantitativo de la distribución de puntos fuertes (PF) y áreas de mejora (AM), según nivel asistencial, centro sanitario y su agrupación en criterios y EETT del Modelo. Resultados: La utilización del modelo EFQM en el conjunto del SSP alcanza el 84% de las gerencias (32/37) y el 94% despliegan planes de mejora (30/32). Se describen 3.543 PF y 3.573 AM, para el SSP. Del total de PF, los criterios agentes suponen un 67,6%.ResultadosLos resultados por EETT resaltan la dominancia de los ejes de gestión de la organización, personas, clientes, proceso y comunicación. Resultados: Las dificultades para su aplicación derivan del liderazgo de la organización en gestión de la calidad, de las estrategias formativas para su despliegue, del carácter novedoso que supone la herramienta en determinados entornos, y de la potencial carga de trabajo generada. Conclusiones: Los EETT se perciben como un método de trabajo factible para la agrupación y síntesis de las AM, precisando una formación adecuada para optimizar su utilización (AU)

Objective: To analyse the use of transversal axes (TA) of the EFQM Model in the self- assessment of the service organisations in an Autonomous Community and to describe the self assessment results for the health care system (HCS) as a whole. Material and methods: Descriptive study divided in two phases: 1) evaluation of the use of the EFQM model in the HCS, and 2) analysis of the methodology using TA. All (37) of the self-assessment reports corresponding to Primary Care and Hospitals in 2007 were analysed. A quantitative analysis was performed on the strengths (S) and areas of improvement (AI) identified, stratifying them according to level of care, centre and EFQM criteria and TA. Results: The use of the EFQM in the HCS reaches 84% of the organizations (32/37), and 94% deploy improvement plans (30/32). A total of 3543 S and 3573 AI were described for the HCS as a whole. From the total identified S, enablers reach 67.66%. Results: Results according to TA the organization management axes are the dominant ones: people, clients, process and communication. Results: Application difficulties derive from the organizations’ leadership in quality management, the training strategies for deployment, the innovation character of the model in certain settings and the potential workload generated. Conclusions: TA are perceived as a feasible work method to gather and synthesize AI. However it requires appropriate training to optimize its use (AU)

[Use of the EFQM red threads in the health public health system]. / Utilización de los ejes transversales del modelo EFQM en el ámbito sanitario público.

OBJECTIVE: To analyse the use of transversal axes (TA) of the EFQM Model in the self- assessment of the service organisations in an Autonomous Community and to describe the self assessment results for the health care system (HCS) as a whole. MATERIAL AND METHODS: Descriptive study divided in two phases: 1) evaluation of the use of the EFQM model in the HCS, and 2) analysis of the methodology using TA. All (37) of the self-assessment reports corresponding to Primary Care and Hospitals in 2007 were analysed. A quantitative analysis was performed on the strengths (S) and areas of improvement (AI) identified, stratifying them according to level of care, centre and EFQM criteria and TA. RESULTS: The use of the EFQM in the HCS reaches 84% of the organizations (32/37), and 94% deploy improvement plans (30/32). A total of 3543 S and 3573 AI were described for the HCS as a whole. From the total identified S, enablers reach 67.66%. Results according to TA the organization management axes are the dominant ones: people, clients, process and communication. Application difficulties derive from the organizations' leadership in quality management, the training strategies for deployment, the innovation character of the model in certain settings and the potential workload generated. CONCLUSIONS: TA are perceived as a feasible work method to gather and synthesize AI. However it requires appropriate training to optimize its use.

Las unidades funcionales para la gestión de riesgos sanitarios (seguridad del paciente / Operational units for health risk management (patient safety)

En 1995, el INSALUD comenzó a desarrollar actuaciones de asesoría en gestión de riesgos que después de las transferencias culminaron en el desarrollo de estructuras funcionales en los centros sanitarios. Estas unidades están compuestas por un conjunto de profesionales, incluidos directivos, y tienen como objetivo identificar, evaluar, analizar y tratar los riesgos sanitarios para mejorar la seguridad de los pacientes. Su estructura organizativa puede variar en función de necesidades, recursos y filosofía de cada organización. En este artículo se presenta la experiencia de las unidades de gestión de riesgo desarrolladas en las comunidades autónomas de Madrid, País Vasco, INGESA (Ceuta y Melilla) y Galicia. Asimismo, se plantea una reflexión sobre la evaluación de su impacto y sus futuras funciones para mejorar la seguridad de los servicios sanitarios (AU)

In 1995 INSALUD began to develop performance measures in the field of risk management, and following transfer of powers to the regions, these led to the development of operational units in individual healthcare centres. These units, which consist of a group of health professionals, including managers, aim to identify, evaluate, analyse and deal with health risks, to enhance patient safety. Their organisational structure can vary in accordance with the needs, resources and philosophy of each individual organisation. This paper presents the experience of the risk management units developed in four Spanish regions: Madrid, the Basque Country, Galicia and INGESA (Ceuta and Melilla). It also includes reflections on assessment of their impact and on their future role in improving safety in healthcare services (AU)

[Operational units for health risk management (patient safety)]. / Las unidades funcionales para la gestión de riesgos sanitarios (seguridad del paciente).

In 1995 INSALUD began to develop performance measures in the field of risk management, and following transfer of powers to the regions, these led to the development of operational units in individual healthcare centres. These units, which consist of a group of health professionals, including managers, aim to identify, evaluate, analyse and deal with health risks, to enhance patient safety. Their organisational structure can vary in accordance with the needs, resources and philosophy of each individual organisation. This paper presents the experience of the risk management units developed in four Spanish regions: Madrid, the Basque Country, Galicia and INGESA (Ceuta and Melilla). It also includes reflections on assessment of their impact and on their future role in improving safety in healthcare services.