Using 'failure mode and effects analysis' to design a surgical safety checklist for safer surgery

Aims: To describe the process of designing a new surgical safety checklist for the prevention of wrong patient and wrong site/side surgery using 'failure mode and effects analysis' (FMEA), and to carry out a compliance audit on the use of the new checklist in a surgical department. Methods: Using FMEA as a tool, a multidisciplinary team of medical professionals in the New Territories East Cluster of the Hospital Authority sought to identify key steps at-risk associated with a patient's journey through elective surgery. The whole process was redesigned and incorporated into a new safety checklist with a view to preventing wrong patient and wrong site/side surgery. A compliance audit was carried out after implementation of the checklist. Results: The newly designed safety checklist, known as '123-Surgical Safety-123', involved a longitudinal series of checkpoints from upstream to downstream with repeated/redundant cross-checking at key steps. The checkpoints included consenting process, sending of patient to the theatre, theatre reception, sign-in, time-out, and sign-out. At each step, one designated person (either a doctor or a nurse) was responsible for checking the correctness of those items listed on the checklist. The new checklist was implemented in February 2009. A compliance audit on the use of the checklist was carried out between 13 February and 17 April 2009. A total of 322 patients were operated on during the study period. The overall compliance rate was 95%. Conclusion: By using FMEA as a platform, a new surgical safety checklist for prevention of wrong patient and wrong site/side surgery was designed and successfully implemented in a surgical department. A high compliance rate was achieved. However, whether or not the implementation of this new checklist will improve the outcome of surgical patients still awaits further evaluation.