Classifying Laboratory Incident Reports to Identify Problems That Jeopardize Patient Safety

Michael L. Astion, MD, PhD, Kaveh G. Shojania, MD, Tim R. Hamill, MD, Sara Kim, PhD, Valerie L. Ng, MD


Am J Clin Pathol. 2003;120(1) 

In This Article

Abstract and Introduction

We developed a laboratory incident report classification system that can guide reduction of actual and potential adverse events. The system was applied retrospectively to 129 incident reports occurring during a 16-month period. Incidents were classified by type of adverse event (actual or potential), specific and potential patient impact, nature of laboratory involvement, testing phase, and preventability. Of 129 incidents, 95% were potential adverse events. The most common specific impact was delay in receiving test results (85%). The average potential impact was 2.9 (SD, 1.0; median, 3; scale, 1-5). The laboratory alone was responsible for 60% of the incidents; 21% were due solely to problems outside the laboratory's authority. The laboratory function most frequently implicated in incidents was specimen processing (31%). The preanalytic testing phase was involved in 71% of incidents, the analytic in 18%, and the postanalytic in 11%. The most common preanalytic problem was specimen transportation (16%). The average preventability score was 4.0 (range, 1-5; median, 4; scale, 1-5), and 94 incidents (73%) were preventable (score, 3 or more). Of the 94 preventable incidents, 30% involved cognitive errors, defined as incorrect choices caused by insufficient knowledge, and 73% involved noncognitive errors, defined as inadvertent or unconscious lapses in expected automatic behavior.

The Institute of Medicine report, To Err Is Human,[1] generated widespread interest in medical error and adverse events in health care, as well as strategies for reducing them.[2] Existing studies have characterized the epidemiology and impact of actual and potential adverse events in a variety of settings.[3,4,5,6,7,8] However, these studies, including benchmark population studies of adverse events among hospitalized patients,[3,8] do not provide explicit information about adverse and potential adverse events related to clinical laboratory services.

Knowledge about actual and potential adverse events related to laboratory services comes from a small number of studies that have focused on the rate of laboratory errors and the classification of the errors by cause, phase of testing, responsible party, and extent of harm to the patient[9,10,11,12,13,14,15,16,17,18,19] (for review, see Bonini et al[20]). Two studies investigated problems occurring across most hospital laboratory services,[9,10] while other studies focused on problems within specific laboratory areas such as clinical chemistry,[11,12] blood banking,[13,14] stat testing,[15] and genetic testing.[16]

The study of actual and potential adverse events related to laboratory testing would benefit from a commonly used, rigorous classification scheme that identifies preventable problems most likely to lead to patient injury and suggests solutions for those problems.[20] We describe a tool that characterizes the nature of important errors and adverse events involving laboratory services. We evaluated the retrospective application of this tool to 129 incidents identified by internal laboratory incident reports or risk management reports as involving some aspect of the clinical laboratory services at a major academic medical center.


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