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.