Safety Analysis of 13 Suspicious Deaths in Intensive Care: Ergonomics and Forensic Approach Compared.

Objectives: Thirteen suspicious deaths occurred in an intensive care unit of Tuscany, Italy, in 2015. All patients developed sudden unexplained coagulopathy leading to severe bleeding. None of them had been prescribed heparin, but supertherapeutic concentrations of heparin were found. After a nurse was arrested on suspicion of murdering Human Factor and Ergonomics (HF/E) experts received a mandate to identify system failures. According to the judgment of the Court of First Instance on April 2019, the nurse was found guilty (of first degree murder? Manslaughter?) METHODS: The HF/E group used a two-pronged safety analysis: understanding the conditions in which the healthcare practitioners were working in the period when the suspicious deaths emerged and reviewing the clinical records. Results: Fourteen patients admitted to the intensive care unit in 2014 and 2015 were selected on the basis of markedly abnormal coagulation tests (n = 13) or a family member's complaint (n = 1). In 13 cases, a massive, abrupt hemorrhage in the presence of an unexpected abnormality of coagulation tests occurred, whereas the fourteenth patient had the only prolongation of coagulation markers without bleeding. All cases examined classified as adverse events related to a coagulation disorder. Human factor and ergonomics analysis identified a number of latent and active failures that contributed to the event and provided a set of important recommendations for safety improvement. Conclusions: When presented with a manifest, albeit suspected, wrongdoing with lethal consequences for patients, forensic investigators and safety investigators have distinctly different goals and methods. We believe that a memorandum of understanding between HF/E and forensic investigative teams provides an operative framework for allowing co-existence and fosters collaboration. The pursuit of safe care as a new emerging right for patients and balancing the right to legal justice with the right to safer healthcare merit further investigation and discussion.