Quality Management: Institution of Incident Reporting in the Clinical Laboratory

• Published in: American journal of clinical pathology 2019-09, Vol.152 (Supplement_1), p.S125-S126
• Main Authors: Reeves, Melissa, Ullah, Ehsan, Hufnagel, Robert, Tumminia, Santa
• Format: Article
• Language: English
• Subjects: Classification; Clinical decision making; Decision making; Medical laboratories; Personnel; Quality management; Risk assessment
• ISSN: 0002-9173; 1943-7722
• DOI: 10.1093/ajcp/aqz124.005

Abstract Introduction Risk assessment is a critical part of quality management for a clinical laboratory. As a part of risk management, it is important to track any deviances from standard operating procedures (SOPs) and document equipment or assay failures consistently. Methods Our laboratory instituted an incident reporting system for reporting any deviances from protocol or equipment failures to track recurrent issues and determine if changes to protocols were necessitated. A guidance for completing the form was used so that the forms were completed in a standardized manner. Each incident is given a unique ID for tracking and identifies who discovered the incident and a secondary person that the incident was reported to at the time of occurrence. The incident is classified as Process, Instrument, Personnel, or Other and could be grouped into more than one category. The Other category includes incidents such as those involving reagent or equipment malfunctions. Incident reports are reviewed and discussed during the weekly lab meeting to determine the most appropriate category(s) for classification. Further, a fixed decision-making algorithm was applied to intervene specifically if the incident (a) was recurring, (b) required an SOP investigation or additional personnel training, and (c) needed to be reported to the institutional review board (IRB). Incidents are tracked until corrective action has been completed and reviewed periodically by the laboratory director. We reviewed the data after our first year of incident reporting to evaluate trends in incident categories. Results and Conclusion Forty-nine incidents were reported December 2017-2018. The highest classification categories included Other and a dual category, Process and Personnel, with 10 reports in each (40.8% overall). Twelve incidents were considered Recurring, 16 prompted SOP updates, and 1 was reported to the IRB. Through incident reporting, we were able to identify and resolve key risk areas in our procedures, which improved our operations and overall quality.