Methodology For Development Of Consensus Guidelines On Root Cause Analysis And Corrective And Preventive Actions For Common Adverse Events In Ophthalmology

Adverse event analysis and preventive actions are the cornerstone of patient safety. To develop a first-of-its-kind structured, consensus-based methodology for Root Cause Analysis (RCA) and corrective and preventive action (CAPA) for common adverse events in ophthalmology. The initiative aimed to formulate a standard guide for institutional processes for identifying, analysing, and preventing adverse events, including near-miss and no-harm incidents, through multidisciplinary and multicentric collaboration using established quality improvement tools.

At times of crisis after adverse events ranging from endophthalmitis to medication errors, a structured guide for RCA and CAPA can be valuable, which we found was not available. Multidisciplinary eye care professionals from Seva Foundation partner hospitals across India, Nepal, and Cambodia came together to discuss quality and patient safety standards. A four-phased review process was carried out as part of these workshops amongst teams who participated between June 2023 and October 2024.

Four structured RCA workshops were conducted in June 2023 (33 participants), January 2024 (12 participants), June 2024 (40 participants), and October 2024 (14 participants). A total of 99 multidisciplinary eye care professionals participated, including ophthalmologists, anesthesiologists, nurses, optometrists, managers, maintenance support staff, and biomedical engineers. Two RCA tools, Ishikawa/ cause-and-effect diagram and 5-Why analysis, were systematically applied to common adverse event scenarios to develop CAPA. Iterative consensus-building was achieved through structured group deliberation, followed by independent subject-matter expert review before finalisation.

The initiative produced a consensus-based practical guide addressing Root Cause Analysis of common ophthalmic adverse events. Recurrent system-level vulnerabilities identified included the absence of standardised operating procedures, variability in staff training, communication failures, and limited monitoring mechanisms. Priority risk domains included cataract surgery, anaesthesia safety, infection prevention, medication management, emergency preparedness, and subspecialty services. The finalised framework provides structured RCA workflows, corrective and preventive action pathways, and standardised reporting processes for adverse, near-miss, and no-harm events to promote institutional learning and safety improvement.

Consensus-based development of an RCA & CAPA guide in ophthalmology is feasible across diverse eyecare settings. Our study can help encourage structured collaborative efforts to develop a similar guide for other regions of the world. This serves as a reproducible model that emphasises system-based preventive actions. Our guide is available for wider adoption of standardised RCA processes and aims at supporting sustained improvements in patient safety and quality in ophthalmic practice.