Content analysis of 50 clinical negligence claims involving test results management systems in general practice

Background and aims: Laboratory test results management systems are a complex safety issue in primary care settings worldwide. Related failures lead to avoidable patient harm, medicolegal action, patient complaints and additional workload to problem solve identified issues. We aimed to review and learn from 50 clinical negligence cases involving system failures related to the management of test results. Methods: The Medical Protection Society database was searched and a convenience sample of 50 claims identified from a 3-year period covering 2014–2016. A content analysis of documentation was undertaken to quantify and theme data, aided by a Risk Assessment Matrix and the Yorkshire Contributory Factors Framework. Quantitative data were subjected to simple descriptive statistical analysis. Results: 14/50 cases (28%) involved a delay in diagnosis or treatment of a patient with cancer. 15 cases were judged to be ‘never events’ (30%) and 85 distinct system issues were identified. Just under half of cases involved a failure to notify patients of an abnormal test result (n=24, 48%), while 18 cases (36%) involved a test result not being actioned by a doctor. The most frequently occurring contributory factors (n=30, 60%) were related to local working conditions, for example, unclear professional responsibilities with regards to test result review or follow-up or lack of patient care continuity. Conclusion: This small study highlights why test result management systems fail and contribute to future litigation, providing new insights in this area. Most claims involved avoidable harm to patients and preventable organisational risks. The findings point to the inadequate design of practice systems and the need for proactive strategies to improve the management of test results in order to reduce patient harm

Is the “never event” concept a useful safety management strategy in complex primary healthcare systems?

Why is the area important?: A sub-group of rare but serious patient safety incidents, known as ‘never events,’ is judged to be ‘avoidable.’ There is growing interest in this concept in international care settings, including UK primary care. However, issues have been raised regarding the well-intentioned coupling of ‘preventable harm’ with zero tolerance ‘never events,’ especially around the lack of evidence for such harm ever being totally preventable. What is already known and gaps in knowledge?: We consider whether the ideal of reducing preventable harm to ‘never’ is better for patient safety than, for example, the goal of managing risk materializing into harm to ‘as low as reasonably practicable,’ which is well-established in other complex socio-technical systems and is demonstrably achievable. We reflect on the ‘never event’ concept in the primary care context specifically, although the issues and the polarized opinion highlighted are widely applicable. Recent developments to validate primary care ‘never event’ lists are summarized and alternative safety management strategies considered, e.g. Safety-I and Safety-II. Future areas for advancing research and practice: Despite their rarity, if there is to be a policy focus on ‘never events,’ then specialist training for key workforce members is necessary to enable examination of the complex system interactions and design issues, which contribute to such events. The ‘never event’ term is well intentioned but largely aspirational—however, it is important to question prevailing assumptions about how patient safety can be understood and improved by offering alternative ways of thinking about related complexities