![]() Identify all involved or knowledgeable personnel.Near miss example: labeling error identified and corrected by pathologist before test resulted to patient.Adverse event example: laboratory test resulted to incorrect patient.Define the adverse event or undesired outcome.References: Proc (Bayl Univ Med Cent) 2001 14:154, Appl Immunohistochem Mol Morphol 2019 27:329.Collaborators: the lead investigator must gather information from all parties, both inside and outside of the laboratory, who may have been involved in the event which led to the incident.Quality leader: the professional responsible for quality must have specific knowledge about critical aspects of the root cause(s) that are uncovered. ![]() Investigative leader: the lead investigator must have working knowledge of laboratory testing and be able to facilitate the formulation of relevant questions, delegate responsibilities and ensure timely investigation.RCA can be used to supplement risk assessment, quality control plans and quality control tools, in developing individualized quality control plans (IQCP) per CMS and CDC guidelines.Laboratory errors may affect many patients.Undesired outcomes are often a result of simultaneous failures in complex laboratory processes and have multiple root causes.RCA can be performed after an unintended outcome (with harm or potential harm) and include all phases of laboratory testing.Common themes for RCA in pathology and laboratory medicine:.Improves safety by reducing the risk of harm from similar future events.Allows for design and implementation of a quality improvement solution that aims to address the failure at its source.Recognizes that negative outcomes are usually reflective of underlying system and process design flaws, not the actions of an individual or random event.An investigative tool to address a specific event, as opposed to a surveillance tool that monitors baseline activity.Objective / goals of RCA: to study causes of undesired pathology and laboratory outcomes and prevent future occurrences.
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