Causes, consequences, detection, and prevention of identification errors in laboratory diagnostics

Abstract

Laboratory diagnostics, a pivotal part of clinical decision making, is no safer than other areas of healthcare, with most errors occurring in the manually intensive preanalytical process. Patient misidentification errors are potentially associated with the worst clinical outcome due to the potential for misdiagnosis and inappropriate therapy. While it is misleadingly assumed that identification errors occur at a low frequency in clinical laboratories, misidentification of general laboratory specimens is around 1% and can produce serious harm to patients, when not promptly detected. This article focuses on this challenging issue, providing an overview on the prevalence and leading causes of identification errors, analyzing the potential adverse consequences, and providing tentative guidelines for detection and prevention based on direct-positive identification, the use of information technology for data entry, automated systems for patient identification and specimen labeling, two or more identifiers during sample collection and delta check technology to identify significant variance of results from historical values. Once misidentification is detected, rejection and recollection is the most suitable approach to manage the specimen.

Preanalytical quality improvement. In pursuit of harmony, on behalf of European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working group for Preanalytical Phase (WG-PRE)

“…Misidentification is not easily detectable, and reporting of identification errors may cause blame for the personnel. Improving patient identification is an ongoing challenge in all types of blood collection procedures and also a critical issue in other healthcare areas [83]. Another intolerable risk was the practice of labeling the test tube at a later occasion away from the patient.…”

Preanalytical quality improvement: from dream to reality

“…Although patient identification errors in transfusion medicine tend to occur in 0.05% of specimens, the rate is much higher in clinical chemistry laboratories, up to 1%. Several factors may contribute to generate identification errors, including malpractice, issues related to workflow, materials used in the identification process, or the approach taken by staff to confirm the identity of individual patients (45).…”

Compliance of blood sampling procedures with the CLSI H3-A6 guidelines: An observational study by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group for the preanalytical phase (WG-PRE)

“…It consists of several discrete steps, all of which can be subject to errors [1,2] which potentially impact patient safety. Amongst the errors are patient/sample misidentification so that analytical results are not associated with the correct patient [3]; alteration of the concentration of some analytes by prolonged use of a tourniquet [4,5] or by contamination of the sample with intravenous fluids [6] and contrast media [7]; inadequate patient preparation, i.e., fasting [8][9][10] or increased physical activity [11]; not achieving the specified blood collection volume, which may lead to the incorrect additive to blood ratio and thus affect the test results [12] and many others. In addition to factors that can affect sample quality, some practices can also have an impact on patient or healthcare worker safety [13].…”