Specimen Labeling Errors: A Q-Probes Analysis of 147 Clinical Laboratories

Archives of Pathology & Laboratory Medicine, Oct 2008 by Wagar, Elizabeth A, Stankovic, Ana K, Raab, Stephen, Nakhleh, Raouf E, Walsh, Molly K

Context.-Accurate specimen identification is critical for quality patient care. Improperly identified specimens can result in delayed diagnosis, additional laboratory testing, treatment of the wrong patient for the wrong disease, and severe transfusion reactions. Specimen identification errors have been reported to occur at rates of 0.1% to 5%.

Objective.-To determine the frequency of labeling errors in a multi-institutional survey.

Design.-Labeling errors were categorized as: (1) mislabeled, (2) unlabeled, (3) partially labeled, (4) incompletely labeled, and (5) illegible label. Blood specimens for routine or stat chemistry, hematology, and coagulation testing were included. Labeling error rates were calculated for each participant and tested for associations with institutional demographic and practice variable information.

Results.-More than 3.3 million specimen labels were reviewed by 147 laboratories. Labeling errors were identified at a rate of 0.92 per 1000 labels. Two variables were statistically associated with lower labeling error rates: (1) laboratories with current, ongoing quality monitors for specimen identification (P = .008) and (2) institutions with 24/7 phlebotomy services for inpatients (P = .02). Most institutions had written policies for specimen labeling at the bedside or in outpatient phlebotomy areas (96% and 98%, respectively). Allowance of relabeling of blood specimens by primary collecting personnel was reported by 42% of institutions.

Conclusions.-Laboratories actively engaged in ongoing specimen labeling quality monitors had fewer specimen labeling errors. Also, 24/7 phlebotomy services were associated with lower specimen error rates. Establishing quality metrics for specimen labeling and deploying 24/7 phlebotomy operations may contribute to improving the accuracy of specimen labeling for the clinical laboratory.

(Arch Pathol Lab Med. 2008;132:1617-1622)

In early surveys, laboratory errors were classified in several ways, including cause, phase of testing, responsible party, and impact on the patient.1 Data from these studies and other sources have shaped our thinking and caused a shift in the approach to laboratory errors. We have now come to recognize that most errors occur outside of the analytic phase and are often beyond the immediate control of the laboratory.2,3

Patient identification and specimen handling are errorprone steps that occur primarily outside the laboratory. In a recent survey of error types associated with invasive procedures, 10 of 17 were related to patient identification failure.4 The College of American Pathologists has surveyed wristband identification errors in a Q-Tracks format and shown that continuous quality monitoring improves patient identification practices.5,6 Both the College of American Pathologists and the Joint Commission have implemented patient identification as a major patient safety goal for 2008.7,8 Specimen labeling errors are a recognized preanalytic source of concern for appropriate patient identification management. In several studies, it has been determined that specimen identification errors occur at a rate ranging from 0.1% to 5%.9-12

The focus of this survey was to determine the frequency of specimen labeling errors from multiple institutions for routine and stat priority chemistry, hematology, and coagulation blood specimens. The goals were to: (1) better define the rate of specimen identification errors by using data from multiple institutions, and (2) identify statistically significant associations with demographics and laboratory practices that may assist individual laboratories in improving their specimen labeling procedures.

MATERIALS AND METHODS

Study Design

This study was conducted from April 1, 2007, through May 31, 2007, with final data submission by June 8, 2007. Participants prospectively reviewed labels from chemistry, hematology, and coagulation specimens until a total of 30 labeling errors were identified or until specimen labels were reviewed for 30 days, whichever came first. Labels were reviewed to determinewhether the required information on them was complete (contained 2 patient identifiers and any additional information required by the laboratory) and corresponded to the specimen requisition. For those labels for which the information was either incomplete or did not correspond to the requisition, the labeling errors were categorized into the following types: (1) mislabeled, (2) unlabeled, (3) partially labeled, (4) incompletely labeled, and (5) illegible label. If more than 1 error type occurred per label, all error types were recorded. The definitions for the error types and terminology used in this study are shown in Table 1.

All blood specimens received for routine or stat chemistry, hematology, and coagulation testing were included in the study. All secondary specimens (whether previously aliquoted at another laboratory or within the laboratory) were excluded. All nonblood specimens, esoteric testing specimens (ie, molecular pathology), and specimens destined for transfusion medicine, microbiology, and anatomic pathology laboratory sections were also excluded.