Using Proactive Risk Assessment (HFMEA) to Improve Patient Safety and Quality Associated with Intraocular Lens Selection and Implantation in Cataract Surgery

Background: A proactive risk assessment using the Healthcare Failure Mode and Effect Analysis (HFMEA) process was completed on the intraocular lens (IOL) selection and implantation process to analyze system vulnerabilities that could cause patient harm. The three largest ophthalmology clinics based on patient surgical volume were studied in the analysis. The analysis included in-clinic eye measurements needed for IOL selection through the actual implantation of the lens in the operating room. Methods: The HFMEA process was used for the analysis. A detailed process and subprocess diagram was created through interviews and observations. A multidisciplinary team met 12 times over a 14-week period, evaluating 170 discrete process and subprocess steps and identifying 177 failure modes and 75 failure mode causes for analysis. Results: A high degree of process variability and lack of a robust quality assurance process was found. Areas for improvement included reducing variability between and within clinics, reducing variability in processes used by surgeons, modifying equipment and software to better support the work processes, and implementing a quality assurance program requiring observation of staff performing their routine work as opposed to relying on self-reports of quality metrics. Conclusion: The HFMEA process provided a more complete understanding of all of the processes associated with cataract surgery. This allowed for the identification of a variety of risk factors to patient safety that had not previously been identified by the more traditional reactive analysis methods, which tend to focus only on vulnerabilities identified by a specific event.