Objective: While internal audits are widely used, insight into the essential components of the internal audit to govern patient safety is limited. The aim of this study is to explore factors that hinder and stimulate internal audits as an effective patient safety governance tool for hospital boards. Methods: A qualitative interview study in six Dutch hospitals. Interviews (n = 43) were held with auditees, quality officers, boards of directors and boards of supervisors. Data were collected and analysed using Grounded Theory. Results: Barriers and facilitators were classified into 14 categories from which four themes emerged: (1) board positioning of audits, (2) organisation and content of audits, (3) competences and composition of audit team, and (4) cultural factors and attitudes towards auditing. Conclusions: We found two themes consisting of factors related to the audit itself (organisation and content of audits, and competences and composition of audit team) and two themes consisting of contextual factors (board positioning of audits, and cultural factors and attitudes towards auditing). These may contribute to support for auditing and to the generation of reliable audit results, which subsequently could result in effective audits for governance of patient safety. Hospital boards and executives can optimise the patient safety auditing system in their hospitals by increasing active leadership engagement, by promoting audits as an opportunity for staff to learn from safety problems (rather than a mandatory examination instrument) and by providing vital resources for a smooth audit process, such as a medical specialist in the audit team.
BackgroundAuditing of patient safety aims at early detection of risks of adverse events and is intended to encourage the continuous improvement of patient safety. The auditing should be an independent, objective assurance and consulting system. Auditing helps an organisation accomplish its objectives by bringing a systematic, disciplined approach to evaluating and improving the effectiveness of risk management, control, and governance. Audits are broadly conducted in hospitals, but little is known about their effects on the behaviour of healthcare professionals and patient safety outcomes. This study was initiated to evaluate the effects of patient safety auditing in hospital care and to explore the processes and mechanisms underlying these effects.Methods and designOur study aims to evaluate an audit system to monitor and improve patient safety in a hospital setting. We are using a mixed-method evaluation with a before-and-after study design in eight departments of one university hospital in the period October 2011–July 2014. We measure several outcomes 3 months before the audit and 15 months after the audit. The primary outcomes are adverse events and complications. The secondary outcomes are experiences of patients, the standardised mortality ratio, prolonged hospital stay, patient safety culture, and team climate. We use medical record reviews, questionnaires, hospital administrative data, and observations to assess the outcomes. A process evaluation will be used to find out which components of internal auditing determine the effects.DiscussionWe report a study protocol of an effect and process evaluation to determine whether auditing improves patient safety in hospital care. Because auditing is a complex intervention targeted on several levels, we are using a combination of methods to collect qualitative and quantitative data about patient safety at the patient, professional, and department levels. This study is relevant for hospitals that want to early detect unsafe care and improve patient safety continuously.Trial registrationNetherlands Trial Register (NTR): NTR3343
ObjectivesHospital boards are legally responsible for safe healthcare. They need tools to assist them in their task of governing patient safety. Almost every Dutch hospital performs internal audits, but the effectiveness of these audits for hospital governance has never been evaluated. The aim of this study is to evaluate the organisation of internal audits and their effectiveness for hospitals boards to govern patient safety.Design and settingA mixed-methods study consisting of a questionnaire regarding the organisation of internal audits among all Dutch hospitals (n=89) and interviews with stakeholders regarding the audit process and experienced effectiveness of audits within six hospitals.ResultsResponse rate of the questionnaire was 76% and 43 interviews were held. In every responding hospital, the internal audits followed the plan–do–check–act cycle. Every hospital used interviews, document analysis and site visits as input for the internal audit. Boards stated that effective aspects of internal audits were their multidisciplinary scope, their structured and in-depth approach, the usability to monitor improvement activities and to change hospital policy and the fact that results were used in meetings with staff and boards of supervisors. The qualitative methods (interviews and site visits) used in internal audits enable the identification of soft signals such as unsafe culture or communication and collaboration problems. Reported disadvantages were the low frequency of internal audits and the absence of soft signals in the actual audit reports.ConclusionThis study shows that internal audits are regarded as effective for patient safety governance, as they help boards to identify patient safety problems, proactively steer patient safety and inform boards of supervisors on the status of patient safety. The description of the Dutch internal audits makes these audits replicable to other healthcare organisations in different settings, enabling hospital boards to complement their systems to govern patient safety.
Objective: To evaluate the effectiveness of internal auditing in hospital care focussed on improving patient safety. Design, Setting and Participants: A before-and-after mixed-method evaluation study was carried out in eight departments of a university medical center in the Netherlands. Intervention(s): Internal auditing and feedback focussed on improving patient safety. Main Outcome Measure(s): The effect of internal auditing was assessed 15 months after the audit, using linear mixed models, on the patient, professional, team and departmental levels. The measurement methods were patient record review on adverse events (AEs), surveys regarding patient experiences, safety culture and team climate, analysis of administrative hospital data (standardized mortality rate, SMR) and safety walk rounds (SWRs) to observe frontline care processes on safety. Results: The AE rate decreased from 36.1% to 31.3% and the preventable AE rate from 5.5% to 3.6%; however, the differences before and after auditing were not statistically significant. The patient-reported experience measures regarding patient safety improved slightly over time (P < 0.001). The SMR, patient safety culture and team climate remained unchanged after the internal audit. The SWRs showed that medication safety and information security were improved (P < 0.05). Conclusions: Internal auditing was associated with improved patient experiences and observed safety on wards. No effects were found on adverse outcomes, safety culture and team climate 15 months after the internal audit.
A well-constructed analysis and feedback of patient safety problems is insufficient to reduce the occurrence of poor patient safety outcomes. Without focus and support in the implementation of audit-based improvement actions, quality improvement by patient safety auditing will remain limited.
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