Cultura de segurança em unidades de terapia intensiva na perspectiva da equipe multiprofissional: Estudo multicêntrico / Cultura de seguridad en unidades de terapia intensiva en la perspectiva del equipo multiprofesional: Estudio multicéntrico / Safety Culture in intensive care units from multiprofessional team perspective: A multicenter study

Resumo Introdução: A Cultura de Segurança do Paciente é considerada um importante componente estrutural dos serviços, que favorece a implantação de práticas seguras e a diminuição da ocorrência de eventos adversos. Objetivo: Identificar os fatores associados à cultura de segurança do paciente nas unidades de terapia intensiva adulto em hospitais de grande porte da região Sudeste do Brasil. Método: Estudo transversal do tipo survey e multicêntrico. Participaram 168 profissionais de saúde de quatro unidades (A, B, C e D) de terapia intensiva adulto. Foi utilizado o questionário "Hospital Survey on Patient Safety Culture". Considerou-se como variável dependente o nível de cultura de segurança do paciente e variáveis independentes aspectos sociodemográficos e laborais. Foram usadas estatísticas descritivas e para a análise dos fatores associados foi elaborado um modelo de regressão logística múltipla. Resultados: Identificou-se associação entre tipo de hospital com onze dimensões da cultura de segurança, quanto à função a categoria profissional médico, técnico de enfermagem e enfermeiro foram relacionadas com três dimensões; o gênero com duas dimensões e tempo de atuação no setor com uma dimensão. Conclusão: Evidenciou-se que o tipo de hospital, categoria profissional, tempo de atuação no setor e gênero foram associados às dimensões de cultura de segurança do paciente.

Resumen Introducción: La cultura de seguridad del paciente se considera un componente estructural importante de los servicios, que favorece la aplicación de prácticas seguras y la reducción de la aparición de acontecimientos adversos. Objetivo: Identificar los factores asociados a la cultura de seguridad del paciente en unidades de terapia intensiva adulto en hospitales de la región Sudeste del Brasil. Metodología: Estudio transversal de tipo encuesta y multicéntrico. Participaron 168 profesionales de salud de cuatro unidades (A, B, C y D) de terapia intensiva adulto. Se utilizó el cuestionario "Hospital Survey on Patient Safety Culture". Se consideró como variable dependiente el nivel de cultura de seguridad del paciente y variables independientes los aspectos sociodemográficos y laborales. Fueron usadas estadísticas descriptivas y, para analizar los factores asociados, fue elaborado un modelo de regresión logística múltiple. Resultados: Se identificó asociación entre tipo de hospital con once dimensiones de cultura de seguridad del paciente. En relación a la función, personal médico, técnicos de enfermería y personal de enfermería fueron asociados con tres dimensiones, el género con dos dimensiones y tiempo de actuación con una dimensión en el modelo de regresión. Conclusión: Se evidenció que el tipo de hospital, función, tiempo de actuación en el sector y género fueron asociados a las dimensiones de la cultura de seguridad del paciente.

Abstract Introduction: Patient safety culture is considered an important structural component of the services, which promotes the implementation of safe practices and the reduction of adverse events. Objective: To identify the factors associated with patient safety culture in adult intensive care units in large hospitals in Belo Horizonte. Method: Cross-sectional survey and multicenter study. A total of 168 health professionals from four units (A, B, C and D) of adult intensive care participated. The questionnaire "Hospital Survey on Patient Safety Culture" was used. The patient's level of safety culture was considered as a dependent variable, and sociodemographic and labor aspects were the independent variables. Descriptive statistics were used and a multiple logistic regression model was developed to analyze the associated factors. Results: An association was identified between the type of hospital and eleven dimensions of the safety culture. In terms of function, the doctors, nursing technicians, and nurse were related to three dimensions; gender with two dimensions, and time working in the sector with one dimension. Conclusion: It was evidenced that the type of hospital, function, time working in the sector, and gender were associated with the dimensions of patient safety culture.

[Indicators and outcomes associated with the quality of care: how to use them and interpret results]. / Indicatori ed esiti associati alla qualità dell'assistenza: come usarli e come interpretare i risultati.

. Indicators and outcomes associated with the quality of care: how to use them and interpret results. Outcomes related to care (or nursing sensitive outcomes) such as pressure ulcers, failure to rescue, accidental falls are specific patient outcomes influenced by nursing care. They are used to monitor the quality of care and patient safety in hospitals across the country. However, their association with nursing care is not always clear, and the attention should be focused on avoidable events. From the following issue a reflection on the main indicators will be proposed with some hints on how to collect data and interpret the results.

Evaluation of SINERGIAPS, an intervention to improve patient safety in primary healthcare centers in Spain based on patients' perceptions and experiences: a protocol for a hybrid type I randomized clinical trial.

Background: Adverse events in the primary care setting result in a direct cost equivalent to at least 2.5% of total healthcare spending. Across OECD countries, they lead to more than seven million avoidable hospital admissions annually. In this manuscript, we describe the protocol of a trial aimed at evaluating the effectiveness of SinergiAPS (a patient-centered audit and feedback intervention) in reducing avoidable hospital admission and explore the factors that may affect its implementation. Methods: We will conduct a 24-month, parallel, open-label, multicenter, pragmatic, hybrid type 1 randomized clinical trial. 118 primary healthcare centers with wide geographical distribution in Spain will be randomly assigned (ratio 1:1) to two groups. The intervention group will receive two audits (baseline and intermediate at 12 months) based on information collected through the administration of the PREOS-PC questionnaire (a measure of patient-reported patient safety) to a convenience sample of 100 patients per center. The intervention group will receive reports on the results of both audits, along with educational resources aimed at facilitating the design and implementation of safety improvement plans. The control group will receive care as usual. The primary outcome will be the rate of avoidable hospitalizations (administrative data). Secondary outcomes: patient-reported patient safety experiences and outcomes (PREOS-PC questionnaire); patient safety culture as perceived by professionals (MOSPSC questionnaire); adverse events reported by healthcare professionals (ad hoc questionnaire); the number of safety improvement actions which the re has implemented (ad hoc questionnaire). Outcome data will be collected at baseline and 24 months follow-up. For the evaluation of the implementation of the SinergiAPS intervention, we will draw on the Consolidated Framework for Implementation Research (CFIR). We will collect and analyze qualitative and quantitative data (30 individual interviews, implementation logbooks; questionnaires for professionals from intervention centers, and level of use of the SinergiAPS web tool). Discussion: This study will expand the scarce body of evidence existing regarding the effects and implementation of interventions aimed at promoting patient and family engagement in primary healthcare, specifically for enhancing patient safety. The study has the potential to produce an impact on clinical practice, healthcare systems, and population health.Clinical Trial Registration: https://clinicaltrials.gov/study/NCT05958108?term=sinergiAPS&rank=1 (NCT05958108).

A palpable sense of frustration with NHS patient safety culture development.

John Tingle, Lecturer in Law, Birmingham Law School, University of Birmingham, discusses two recent reports on NHS patient safety.

Putting Patient Safety First for the Quality Care: An Essential Component at all Healthcare Settings.

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Knowledge and Perception Regarding Medication Error Among Nurses.

BACKGROUND: Patient safety is the major concern in providing quality care. Medication errors have been identified as the most common type of preventable errors. This study aimed to assess the knowledge and perception regarding medication error among nurses. METHODS: A quantitative cross-sectional research design was used. The study was conducted in four different private hospitals in Lalitpur. A total enumerative sampling technique was used to select 302 nurses from these hospitals. Descriptive statistical methods were used to assess socio-demographic variables and inferential statistics methods such as the chi-squared test was used to analyse the association between knowledge, perception, and its socio-demographic characteristics. RESULTS: Most of the respondents 244 (80.8%) agreed the cause of medication error occurs due to unclear handwriting and 217 (71.9%) agreed prescribing the wrong route or dose and time. Mostly respondents 126 (41.7%) had inadequate knowledge, 101 (33.4%) had adequate knowledge and 75 (24.8%) had moderate knowledge on medication error. Mostly respondents 273 (90.4%) had positive perception and 26 (8.6 %) had negative perception. CONCLUSIONS: Most of the nurses had inadequate knowledge but has positive perception on medication error. Appropriate strategies for reducing nurses' workload, barriers to reporting, and sensitization workshops in a regular basis by the administrator should be developed to address medication errors and enhance patient safety in hospital settings.

How much time do emergency department physicians spend on medication-related tasks? A time- and-motion study.

BACKGROUND: Medication-related problems are an important cause of emergency department (ED) visits, and medication errors are reported in up to 60% of ED patients. Procedures such as medication reconciliation and medication review can identify and prevent medication-related problems and medication errors. However, this work is often time-consuming. In EDs without pharmacists, medication reconciliation is the physician's responsibility, in addition to the primary assignments of examining and diagnosing the patient. The aim of this study was to identify how much time ED physicians spend on medication-related tasks when no pharmacists are present in the EDs. METHODS: An observational time-and-motion study of physicians in three EDs in Northern Norway was conducted using Work Observation Method by Activity Timing (WOMBAT) to collect and time-stamp data. Observations were conducted in predefined two-hour observation sessions with a 1:1 relationship between observer and participant, during Monday to Friday between 8 am and 8 pm, from November 2020 to October 2021. RESULTS: In total, 386 h of observations were collected during 225 observation sessions. A total of 8.7% of the physicians' work time was spent on medication-related tasks, of which most time was spent on oral communication about medications with other physicians (3.0%) and medication-related documentation (3.2%). Physicians spent 2.2 min per hour on medication reconciliation tasks, which includes retrieving medication-related information directly from the patient, reading/retrieving written medication-related information, and medication-related documentation. Physicians spent 85.6% of the observed time on non-medication-related clinical or administrative tasks, and the remaining time was spent standby or moving between tasks. CONCLUSION: In three Norwegian EDs, physicians spent 8.7% of their work time on medication-related tasks, and 85.6% on other clinical or administrative tasks. Physicians spent 2.2 min per hour on tasks related to medication reconciliation. We worry that patient safety related tasks in the EDs receive little attention. Allocating dedicated resources like pharmacists to contribute with medication-related tasks could benefit both physicians and patients.

The National Healthcare Safety Network's digital quality measures: CDC's automated measures for surveillance of patient safety.

OBJECTIVE: This article presents the National Healthcare Safety Network (NHSN)'s approach to automation for public health surveillance using digital quality measures (dQMs) via an open-source tool (NHSNLink) and piloting of this approach using real-world data in a newly established collaborative program (NHSNCoLab). The approach leverages Health Level Seven Fast Healthcare Interoperability Resources (FHIR) application programming interfaces to improve data collection and reporting for public health and patient safety beginning with common, clinically significant, and preventable patient harms, such as medication-related hypoglycemia, healthcare facility-onset Clostridioides difficile infection, and healthcare-associated venous thromboembolism. CONCLUSIONS: The NHSN's FHIR dQMs hold the promise of minimizing the burden of reporting, improving accuracy, quality, and validity of data collected by NHSN, and increasing speed and efficiency of public health surveillance.

Journey of medication reconciliation compliance in a lower middle-income country: a retrospective chart review.

OBJECTIVE: There were three main objectives of the study: to determine the overall compliance of medication reconciliation over 4 years in a tertiary care hospital, to compare the medication reconciliation compliance between paper entry (initial assessment forms) and computerised physician order entry (CPOE), and to identify the discrepancies between the medication history taken by the physician at the time of admission and those collected by the pharmacist within 24 hours of admission. METHODS: This study was conducted at a tertiary care hospital in a lower middle-income country. Data were gathered from two different sources. The first source involved retrospective data obtained from the Quality and Patient Safety Department (QPSD) of the hospital, consisting of records from 8776 patients between 2018 and 2021. The second data source was also retrospective from a quality project initiated by pharmacists at the hospital. Pharmacists collected data from 1105 patients between 2020 and 2021, specifically focusing on medication history and identifying any discrepancies compared with the history documented by physicians. The collected data were then analysed using SPSS V.26. RESULTS: The QPSD noted an improvement in physician-led medication reconciliation, with a rise from 32.7% in 2018 to 69.4% in 2021 in CPOE. However, pharmacist-led medication reconciliation identified a 25.4% (n=281/1105) overall discrepancy in the medication history of patients admitted from 2020 to 2021, mainly due to incomplete medication records in the initial assessment forms and CPOE. Physicians missed critical drugs in 4.9% of records; pharmacists identified and updated them. CONCLUSION: In a lower middle-income nation where hiring pharmacists to conduct medication reconciliation would be an additional cost burden for hospitals, encouraging physicians to record medication history more precisely would be a more workable method. However, in situations where cost is not an issue, it is recommended to adopt evidence-based practices, such as integrating clinical pharmacists to lead medication reconciliation, which is the gold standard worldwide.

Still a long way to go on patient safety.

Sam Foster, Executive Director of Professional Practice, Nursing and Midwifery Council, looks at the findings of a parliamentary review into progress on safety proposals and encourages nurses to be part of the culture change.

Psychosocial working conditions, perceived patient safety and their association in emergency medical services workers in Germany - a cross-sectional study.

BACKGROUND: Emergency medical service (EMS) workers face challenging working conditions that are characterized by high stress and a susceptibility to making errors. The objectives of the present study were (a) to characterize the psychosocial working conditions of EMS workers, (b) to describe the perceived quality of patient care they provide and patient safety, and (c) to investigate for the first time among EMS workers associations of psychosocial working conditions with the quality of patient care and patient safety. METHODS: For this cross-sectional study, we carried out an online survey among 393 EMS workers who were members of a professional organization. Working conditions were measured by the Demand-Control-SupportQuestionnaire (DCSQ) and seven self-devised items covering key stressors. Participants reported how often they perceived work stress to affect the patient care they provided and we inquired to what extent they are concerned to have made a major medical error in the last three months. Additionally, we used parts of the Emergency Medical Services - Safety Inventory (EMS-SI) to assess various specific errors and adverse events. We ran descriptive analyses (objective a and b) and multivariable logistic regression (objective c). RESULTS: The most common stressors identified were communication problems (reported by 76.3%), legal insecurity (69.5%), and switching of colleagues (48.9%) or workplaces (44.5%). Overall, 74.0% reported at least one negative safety outcome based on the EMS-SI. Concerns to have made an important error and the perception that patient care is impaired by work stress and were also frequent (17.8% and 12.7%, respectively). Most psychosocial working conditions were associated with the perception that patient care is impaired due to work stress. CONCLUSIONS: Work stress in EMS staff is pronounced and negative safety outcomes or potential errors are perceived to occur frequently. Poor psychosocial working conditions were only consistently associated with perceived impairment of patient care due to work stress. It seems necessary to reduce communication problems and to optimize working processes especially at interfaces between emergency services and other institutions. Legal insecurity could be reduced by clarifying and defining responsibilities. Communication and familiarity between team colleagues could be fostered by more consistent composition of squads.

Patients' perspectives on quality and patient safety failures: lessons learned from an inquiry into transvaginal mesh in Australia.

BACKGROUND: Transvaginal mesh (TVM) surgeries emerged as an innovative treatment for stress urine incontinency and/or pelvic organ prolapse in 1996. Years after rapid adoption of these surgeries into practice, they are a key example of worldwide failure of healthcare quality and patient safety. The prevalence of TVM-associated harms eventually prompted action globally, including an Australian Commonwealth Government Senate Inquiry in 2017. METHOD: We analysed 425 submissions made by women (n = 417) and their advocates (n = 8) to the Australian Senate Inquiry, and documents from 5 public hearings, using deductive and inductive coding, categorisation and thematic analysis informed by three 'linked dilemmas' from healthcare quality and safety theory. We focused on women's accounts of: a) how harms arose from TVM procedures, and b) micro, meso and macro factors that contributed to their experience. Our aim was to explain, from a patient perspective, how these harms persisted in Australian healthcare, and to identify mechanisms at micro, meso and macro levels explaining quality and safety system failure. RESULTS: Our findings suggest three mechanisms explaining quality and safety failure: 1. Individual clinicians could ignore cases of TVM injury or define them as 'non-preventable'; 2. Women could not go beyond their treating clinicians to participate in defining and governing quality and safety; and. 3. Health services set thresholds for concern based on proportion of cases harmed, not absolute number or severity of harms. CONCLUSION: We argue that privileging clinical perspectives over patient perspectives in evaluating TVM outcomes allowed micro-level actors to dismiss women's lived experience, such that women's accounts of harms had insufficient or no weight at meso and macro levels. Establishing system-wide expectations regarding responsiveness to patients, and communication of patient reported outcomes in evaluation of healthcare delivery, may help prevent similar failures.

Grading recommendations for enhanced patient safety in sentinel event analysis: the recommendation improvement matrix.

OBJECTIVES: The goal of sentinel event (SE) analysis is to prevent recurrence. However, the rate of SEs has remained constant over the past years. Research suggests this is in part due to the quality of recommendations. Currently, standards for the selection of recommendations are lacking. Developing a method to grade recommendations could help in both designing and selecting interventions most likely to improve patient safety. The aim of this study was to (1) develop a user-friendly method to grade recommendations and (2) assess its applicability in a large series of Dutch perioperative SE analysis reports. METHODS: Based on two grading methods, we developed the recommendation improvement matrix (RIM). Applicability was assessed by analysing all Dutch perioperative SE reports over a 12-month period. After which interobserver agreement was studied. RESULTS: In the RIM, two elements are crucial: whether the recommendation intervenes before or after an SE and whether it eliminates or controls the hazard. Applicability was evaluated in 115 analysis reports, encompassing 161 recommendations. Recommendation quality varied from the highest, category A, to the lowest, category D, with category A accounting for 44%, category B for 35%, category C for 2% and category D for 19% of recommendations. There was a fair interobserver agreement. CONCLUSION: The RIM can be used to grade recommendations in SE analysis and could possibly help in both designing and selecting interventions. It is relatively simple, user-friendly and has the potential to improve patient safety. The RIM can help formulate effective and sustainable recommendations, a second key objective of the RIM is to foster and facilitate constructive dialogue among those responsible for patient safety.

Paving the Path for Sustainable and Responsible Off-Label Use of Pharmaceutical Products in Europe.

Off-label use of pharmaceuticals involves a wide array of aspects ranging from legal and regulatory ones to clinical to safety considerations. Access to off-label therapies is particularly relevant question for patients in areas of unmet medical need. Simultaneously, off-label use also triggers wider considerations relating to social and economic sustainability of health care systems and access to health. National authorities have adapted different regulatory approaches to off-label use of pharmaceuticals, ranging from (1) "regulatory silence"; to (2) allowing off-label use at the discretion of the treating physician; and to (3) a more stringent approach in which off-label use is subject to third party approval. This article provides a brief overview of these different regulatory approaches from a helicopter perspective, and it discusses benefits and shortcomings these approaches. Finally, it presents ideas for preconditions for sustainable and responsible off-label use of pharmaceutical products to ensure patient safety whilst ensuring their timely access to health.

Taking a reading on NHS patient safety: views from the ombudsman.

John Tingle, Lecturer in Law, Birmingham Law School, University of Birmingham, discusses several reports where the Parliamentary and Health Service Ombudsman addresses some critical NHS patient safety issues.

Development of a scoring system to quantify errors from semantic characteristics in incident reports.

OBJECTIVES: Incident reporting systems are widely used to identify risks and enable organisational learning. Free-text descriptions contain important information about factors associated with incidents. This study aimed to develop error scores by extracting information about the presence of error factors in incidents using an original decision-making model that partly relies on natural language processing techniques. METHODS: We retrospectively analysed free-text data from reports of incidents between January 2012 and December 2022 from Nagoya University Hospital, Japan. The sample data were randomly allocated to equal-sized training and validation datasets. We conducted morphological analysis on free text to segment terms from sentences in the training dataset. We calculated error scores for terms, individual reports and reports from staff groups according to report volume size and compared these with conventional classifications by patient safety experts. We also calculated accuracy, recall, precision and F-score values from the proposed 'report error score'. RESULTS: Overall, 114 013 reports were included. We calculated 36 131 'term error scores' from the 57 006 reports in the training dataset. There was a significant difference in error scores between reports of incidents categorised by experts as arising from errors (p<0.001, d=0.73 (large)) and other incidents. The accuracy, recall, precision and F-score values were 0.8, 0.82, 0.85 and 0.84, respectively. Group error scores were positively associated with expert ratings (correlation coefficient, 0.66; 95% CI 0.54 to 0.75, p<0.001) for all departments. CONCLUSION: Our error scoring system could provide insights to improve patient safety using aggregated incident report data.

[Patient safety training for ward clerks of an Occupational Mutual Insurance Company collaborating with the Social Security, immediate impact and after six months]. / Formación en seguridad del paciente para el personal administrativo de una Mutua Colaboradora con la Seguridad Social, impacto inmediato y a los seis meses.

INTRODUCTION: Ward Clerks are an essential part of the healthcare team, as they provide administrative and organizational support in healthcare institutions. The aim of this study is to determine the training impact of a basic one-hour online course on patient safety for this staff. METHOD: A quasi-experimental before/after study carried out on a population of 170 administrative staff working in the centers of an Occupational Mutual Insurance Company (MC Mutual) who took the patient safety course. A convenience sample of 22 administrative professionals, who agreed to participate, was chosen from this population, which made it possible to reconstruct their knowledge before and after the course, by examination and interview, immediately after the course and at 6 months. RESULTS: Of the 170 professionals participating in the course, 167 (98.2%) completed the initial test and the post-test, with mean scores increasing from 5.7 (P1) to 7.3 (P2) (p<0.05). A total of 22 out of a sample of 42 (52.4%) agreed to participate in the interviews and all three interviews were achieved by 21 (E1), 22 (E2) and 19 (E3) professionals, whose mean scores increased from 5.9 (E1) to 7.2 (E2) and 7.5 (E3) (p<0.05). CONCLUSIONS: The results suggest that the training course was effective. The evaluation by interview 6 months after the course indicates a likely medium to long term effect. The involvement of administrative professionals in the the Company´s patients care is key. Evaluating the impact of an intervention is essential to inform its effectiveness and guide its planning.

Introducción: El personal administrativo es un colectivo esencial. El objetivo de este estudio es analizar el impacto formativo de un curso online básico sobre seguridad del paciente para administrativos.  Método: Estudio cuasi experimental antes/después en una población de 170 administrativos/as que prestaban sus servicios en los centros de la Mutua Colaboradora con la Seguridad Social MC Mutual y que realizaron un curso de seguridad del paciente. Se evaluaron los conocimientos adquiridos mediante una prueba al inicio (P1) y al final del curso (P2). Además, se eligió una muestra de conveniencia de 42 administrativos/as para evaluar sus conocimientos mediante entrevista, previos (E1) y posteriores (E2) al curso, y a los 6 meses (E3). Resultados: De los 170 administrativos/as participantes en el curso, 167 (98,2%) completaron la prueba al inicio y final, con puntuaciones medias que incrementaron de 5,7 (P1) a 7,3 (P2) (p<0,05). Aceptaron participar en las entrevistas 22 administrativos/as de una muestra de 42 (52,4%), y se consiguieron las tres entrevistas de 21 (E1), 22 (E2) y 19 (E3) administrativos/as, cuyas puntuaciones medias incrementaron desde 5,9 (E1) a 7,2 (E2) y 7,5 (E3) (p<0,05).  Conclusiones: Los resultados sugieren que el curso de formación fue efectivo. La evaluación mediante la entrevista a los seis meses del curso indica un probable efecto a medio-largo plazo. La implicación de los/as profesionales administrativos/as en la atención a los usuarios de la Mutua es clave. La evaluación del impacto de una intervención es esencial para informar sobre su efectividad y orientar su planificación.