Recognizing and Reducing Analytical Errors and Sources of Variation in Clinical Pathology Data in Safety Assessment Studies.
Veterinary clinical pathologists are well positioned via education and training to assist in investigations of unexpected results or increased variation in clinical pathology data. Errors in testing and unexpected variability in clinical pathology data are sometimes referred to as "laboratory errors." These alterations may occur in the preanalytical, analytical, or postanalytical phases of studies. Most of the errors or variability in clinical pathology data occur in the preanalytical or postanalytical phases. True analytical errors occur within the laboratory and are usually the result of operator or instrument error. Analytical errors are often ≤10% of all errors in diagnostic testing, and the frequency of these types of errors has decreased in the last decade. Analytical errors and increased data variability may result from instrument malfunctions, inability to follow proper procedures, undetected failures in quality control, sample misidentification, and/or test interference. This article (1) illustrates several different types of analytical errors and situations within laboratories that may result in increased variability in data, (2) provides recommendations regarding prevention of testing errors and techniques to control variation, and (3) provides a list of references that describe and advise how to deal with increased data variability.
1 Pathology Department, Toxicology Division, Lilly Research Laboratories, Indianapolis, IN, USA.
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Schultze
1 Pathology Department, Toxicology Division, Lilly Research Laboratories, Indianapolis, IN, USA.
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Irizarry
D000818:Animals; D019411:Clinical Laboratory Techniques / Q000592:standards*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis*; D006801:Humans; D019300:Medical Errors / Q000517:prevention & control*; D010338:Pathology, Clinical / Q000592:standards*; D011786:Quality Control
analytical errors; clinical pathology; laboratory testing errors; quality control; unexpected data variation