Design for patient safety: a systems-based risk identification framework.

Current risk identification practices applied to patient safety in healthcare are insufficient. The situation can be improved, however, by studying systems approaches broadly and successfully utilised in other safety-critical industries, such as aviation and chemical industries. To illustrate this, this paper first investigates current risk identification practices in the healthcare field, and then examines the potential of systems approaches. A systems-based approach, called the Risk Identification Framework (RID Framework), is then developed to enhance improvement in risk identification. Demonstrating the strengths of using multiple inputs and methods, the RID Framework helps to facilitate the proactive identification of new risks. In this study, the potential value of the RID Framework is discussed by examining its application and evaluation, as conducted in a real-world healthcare setting. Both the application and evaluation of the RID Framework indicate positive results, as well as the need for further research. Practitioner Summary: The findings in this study provide insights into how to make a better amalgamation of risk identification inputs to the safer design and more proactive risk management of healthcare delivery systems, which have been an increasing research interest amongst human factor professionals and ergonomists.

Trust-level risk identification guidance in the NHS East of England.

BACKGROUND: In healthcare, a range of methods are used to improve patient safety through risk identification within the scope of risk management. However, there is no evidence determining what trust-level guidance exists to support risk identification in healthcare organisations. This study therefore aimed to determine such methods through the content analysis of trust-level risk management documents. METHOD: Through Freedom of Information Act, risk management documents were requested from each acute, mental health and ambulance trust in the East of England region of NHS for content analysis. Received documents were also compared with guidance from other safety-critical industries to capture differences between the documents from those industries, and learning points to the healthcare field. RESULTS: A total of forty-eight documents were received from twenty-one trusts. Incident reporting was found as the main method for risk identification. The documents provided insufficient support for the use of prospective risk identification methods, such as Prospective Hazard Analysis (PHA) methods, while the guidance from other industries extensively promoted such methods. CONCLUSION: The documents provided significant insight into prescribed risk identification practice in the chosen region. Based on the content analysis and guidance from other safety-critical industries, a number of recommendations were made; such as introducing the use of PHA methods in the creation and revision of risk management documents, and providing individual guidance on risk identification to promote patient safety further.

Application of the IHI Global Trigger Tool in measuring the adverse event rate in a Turkish healthcare setting.

BACKGROUND: The goal of this study was to measure an adverse event rate and determine the potential usefulness of the Institute for Healthcare Improvement's Global Trigger Tool (GTT). Besides using the GTT to measure the adverse event rate, a comparison was also made with the internal Voluntary Reporting Notification System (VRNS) to identify and compare the strengths and weaknesses of the two approaches. METHOD: Retrospective data were collected from reported patient safety incidents covering a one-year period at Duzce University Hospital, Turkey. Using a range of selection criteria, a total of 219 patient records were selected and then reviewed by a trained GTT team, to investigate the positive triggers in the content of the patient records. RESULTS: It was determined that adverse events per 1000 patient days totalled 80.72. Adverse events per 100 admissions were 29.39, and the rate of admissions with adverse events was 16.67%. The comparison between the GTT and the VRNS showed that the GTT is 19 times more sensitive than the VRNS in the adverse event evaluation process. CONCLUSION: This is the first published study of the rate of adverse events in a Turkish healthcare setting using the GTT. It was found that the GTT was applicable in this setting, yielding more accurate measurement of the adverse event rate. However, the content of the GTT should be adjusted regarding the standards and documentations used in the Turkish healthcare system to be more useful.

The regulation of mobile medical applications.

The rapidly expanding number of mobile medical applications have the potential to transform the patient-healthcare provider relationship by improving the turnaround time and reducing costs. In September 2013, the U.S. Food and Drug Administration (FDA) issued guidance to regulate these applications and protect consumers by minimising the risks associated with their unintended use. This guidance distinguishes between the subset of mobile medical apps which may be subject to regulation and those that are not. The marketing claims of the application determine the intent. Areas of concern include compliance with regular updates of the operating systems and of the mobile medical apps themselves. In this article, we explain the essence of this FDA guidance by providing examples and evaluating the impact on academia, industry and other key stakeholders, such as patients and clinicians. Our assessment indicates that awareness and incorporation of the guidelines into product development can hasten the commercialisation and market entry process. Furthermore, potential obstacles have been discussed and directions for future development suggested.