Using Proactive Risk Assessment (HFMEA) to Improve Patient Safety and Quality Associated with Intraocular Lens Selection and Implantation in Cataract Surgery Joseph M. DeRosier, PE, CSP; Beth K. Hansemann, COT; Michael W. Smith-Wheelock, MD; James P. Bagian, MD, PE Background: A proactive risk assessment using the Healthcare Failure Mode and Effect Analysis (HFMEA) process was com- pleted 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 in- cluded 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 in- terviews 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 equip- ment 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. C ataract surgery is the most common surgical procedure performed in the United States, with more than three million procedures performed per year, 1 and about 50 mil- lion people are projected to have cataracts by 2050. 2 It is also one of the procedures with the highest reported incidence of incorrect surgery, with errors such as implantation of the wrong intraocular lens (IOL), surgery performed on the wrong eye, and surgery performed on the wrong patient. 3,4 Although serious and permanent complications resulting from cataract surgery are rare, 1 incorrect surgery is serious and avoidable, representing an opportunity to improve the quality and safety of patient care. To improve the cataract surgery process and enhance the quality and safety of patient care, Michigan Medicine’s Kel- logg Eye Center (KEC) initiated a proactive risk assessment of the cataract surgery process in December 2017 using the Healthcare Failure Mode and Effect Analysis (HFMEA) model developed by the VA National Center for Patient Safety in 2001. 5 This comprehensive, proactive HFMEA ap- proach was pursued because adverse events and close calls continued to occur despite implementation of corrective ac- tions from prior traditional adverse event investigations. The desire was to not only address the vulnerabilities that were the cause of the previous adverse events but to identify additional potential vulnerabilities that could be mitigated before they resulted in an unintended adverse outcome. Joint Commission Leadership (LD) Standard LD.03.09.01, Ele- ment of Performance 7, also requires that a proactive risk as- sessment be completed at least every 18 months. 6 The HFMEA model requires analyzing and diagramming the care process in terms of primary process steps or tasks and subprocess steps. An example of an abbreviated process flow diagram is provided in Figure 1. Each subprocess is brainstormed by the HFMEA team to identify what could go wrong that would prevent the step from being completed correctly (failure modes [FMs]) and why these FMs would occur (failure mode causes [FMCs]). The severity and prob- ability of each FM and FMC are selected, using the HFMEA severity and probability definitions, to reveal the hazard score, which is used in the HFMEA decision tree. Those FMs and FMCs that require further action are assessed by the team on the HFMEA worksheet (Figure 2) to document any existing effective control measures and need for correc- tive action(s). METHODS This HFMEA was initiated based on patient safety reports submitted on care activities associated with the cataract sur- gery process. The scope of the analysis was focused on 3 of 10 clinic locations at KEC in which patients present for 1553-7250/$-see front matter © 2019 Published by Elsevier Inc. on behalf of The Joint Commission. https://doi.org/10.1016/j.jcjq.2019.06.003 The Joint Commission Journal on Quality and Patient Safety xxxx; xxx:xxx–xxx