Abstract
INTRODUCTION: Regulation through statutory reporting is used in healthcare internationally to improve accountability, quality of care and patient safety. Since 2017, within the National Health Service (NHS) in England, NHS Secondary Care Trusts (NSCTs) are legally required to report annually both quantitative and qualitative information related to patient deaths within their care within their publicly available Quality Accounts as part of a countrywide patient safety programme: The Learning from Deaths (LfDs) programme. METHOD: All LfDs reports published between 2017 (programme inception) and 2020 were reviewed and evaluated through a critical realist lens, quantitatively reported using descriptive statistics and qualitatively using reflexive thematic analysis. RESULTS: In 2017/2018, 44% of NSCTs reported all six statutory elements of the LfDs reporting regulations, in 2019/2020 35% of NSCTs were reporting this information. A small number of NSCTs did not report any parts of the LfDs regulatory requirements between 2017 and 2020. Multiple qualitative themes arose from this study suggesting problematic engagement with the LfDs programme, erroneous reporting accuracy and errors in written communication. CONCLUSIONS: The LfDs programme has, to some extent, reduced variation and improved consistency to the way that NSCTs identify, report and investigate deaths. However, 3 years into the LfDs programme, the majority of NSCTs are not reporting as required by law. This makes the validity of National statutory reporting in Quality Accounts within the NHS in England questionable as a regulatory process.