Andrew P. Norgan, MD, PhD; Kurt E. Simon, MBA, PMP; Barbara A. Feehan, CBAP; Lynn L. Saari, MSN, RN, CPAN; Joseph M. Doppler, MT(ASCP), CLSp(MB); G. Scott Welder, MA; John A. Sedarski, BS; Christopher T. Yoch, MAI; Nneka I. Comfere, MD; John A. Martin, MD; Brian J. Bartholmai, MD; R. Ross Reichard, MD
Context.—Preanalytic errors, including specimen labeling errors and specimen loss, occur frequently during specimen collection, transit, and accessioning. Radio-frequency identification tags can decrease specimen identification and tracking errors through continuous and automated tracking of specimens.
Objective.—To implement a specimen tracking infrastructure to reduce preanalytic errors (specimen mislabeling or loss) between specimen collection and laboratory accessioning. Specific goals were to decrease preanalytic errors by at least 70% and to simultaneously decrease employee effort dedicated to resolving preanalytic errors or investigating lost specimens.
Design.—A radio-frequency identification specimen-tracking system was developed. Major features included integral radio-frequency identification labels (radio-frequency identification tags and traditional bar codes in a single printed label) printed by point-of-care printers in collection suites; dispersed radio-frequency identification readers at major transit points; and systems integration of the electronic health record, laboratory information system, and radio-frequency identification tracking system to allow for computerized physician order entry driven label generation, specimen transit time tracking, interval-based alarms, and automated accessioning.
Results.—In the 6-month postimplementation period, 6 mislabeling events occurred in collection areas using the radio-frequency identification system, compared with 24 events in the 6-month preimplementation period (75%decrease; P ¼ .001). In addition, the system led to the timely recovery of 3 lost specimens. Labeling expenses were decreased substantially in the transition from high-frequency to ultrahigh frequency radio-frequency identification tags.
Conclusions.—Radio-frequency identification specimen tracking prevented several potential specimen-loss events, decreased specimen recovery time, and decreased specimen labeling errors. Increases in labeling/tracking expenses for the system were more than offset by time savings and loss avoidance through error mitigation.
(Arch Pathol Lab Med. 2020;144:189–195; doi: 10.5858/arpa.2019-0011-OA)
A guiding principle of laboratory medicine is to reduce preanalytic, analytic, and postanalytic sources of error to continuously improve patient care. Laboratories that provide high-quality and reliable results address analytic and postanalytic sources of error directly, but preanalytic errors (eg, specimen mislabeling or loss), which are the largest source of risk in laboratory testing, frequently occur outside of the laboratory domain.1–4 Pathologists often have limited oversight of practices in clinical areas collecting specimens, yet elimination of specimen-mislabeling errors remains a Joint Commission National Patient Safety Goals priority for laboratories,5 and, ultimately, quality systems in pathology must address and mitigate all sources of preanalytic error to be effective.
The frequency of specimen loss in anatomic pathology is not known; it is thought to be rare, but estimates in the literature have ranged from 0.002% to 0.1%.1,6 Mislabeling events are far more common and account for most preanalytic errors.1 Root cause analyses of specimen mislabeling and loss events have revealed various sources of error, including mix-ups due to specimen and label batching, failure to label specimens, incorrect (wrong patient) specimen labels, manual data entry errors, and loss during transport from collection site to laboratory.7 Technology has been instrumental in preanalytic error reduction; in particular, computerized provider order entry and specimen barcoding have fostered major decreases in error rates.8,9 Properly implemented computerized provider order entry standardizes ordering processes, eliminates missing order components, and notiﬁes the laboratory to expect a specimen.10 Bar coding of specimens for tracking and identiﬁcation has most likely been the greatest contributor to decreases in preanalytical error and has also enabled the use of automation in specimen accessioning and processing.11 Yet, despite these successes, specimen identiﬁcation and tracking errors still occur, and there remains a need for technologic and process solutions to further reduce such errors in pathology practice.
Radio-frequency identiﬁcation (RFID) tags have been proposed as a potential solution for specimen identiﬁcation and tracking in anatomic and clinical pathology.12–14 Radio-frequency identiﬁcation tags are small integrated circuits with an antenna.15 Tags are available in active (battery-powered) or passive (deriving energy from the radio signal emitted by the reader) varieties and operate within a series of regulated frequency ranges, from low frequency to microwave (Table 1).12,16,17 Passive RFID tags are powered entirely by the radio-frequency signal emitted by the tag reader, with size and range characteristics determined by the frequency of operation and type of coupling that powers the tag.18 Radio-frequency identiﬁcation is widely used in sectors such as manufacturing, agriculture, ﬁnance, retail, and government.15 To date, RFID has seen some limited adoption in health care for applications that include patient identiﬁcation and localization, staff identiﬁcation and localization, pharmaceutical inventory, equipment tracking, and supply chain management.19
Current examples of RFID use in laboratory medicine and pathology include blood product tracking and specimen labeling and tracking; although experiences with RFID tracking in pathology are limited, the reports have been largely positive.16,20,21 In a trial implementation involving a 14-bed bone marrow transplant unit and remote emergency department blood storage unit, the use of RFID technology led to an 83% reduction in process errors and 10% reduction in labor expenses (system payback calculated at 2–5 years) in their transfusion medicine practice.21 Two studies have reported on RFID specimen tracking for anatomic pathology. One study observed signiﬁcant decreases in both minor and clinically signiﬁcant labeling errors after introduction of RFID to an outpatient gastrointestinal endoscopy practice.20 Another pilot study of end-to-end RFID specimen labeling and tracking of 1067 prostate biopsy specimens through preanalytic, postanalytic, and analytic phases reported signiﬁcant workﬂow efﬁciencies but limited overall success (78.3% of specimens) in specimen tracking, largely because of software errors and tag failure.16
In 2007, investigators at our institution launched a pilot study using a high frequency (HF; 13.56 MHz) Library Sciences RFID system (3M) for tracking endoscopy specimens from gastroenterology and colorectal surgery (GI/CRS).20 During the initial 3-month period, HF RFID tracking led to a large decrease in the number of mislabeled or unlabeled specimens, from a baseline of 765 to 47 (93%). Importantly, of those 47 errors, only 2 had the potential for patient harm, and because of the HF RFID system, both were identiﬁed and corrected before patient harm could occur. In the subsequent years, HF RFID tags continued to perform well, leading to consistently lower specimen mislabeling rates when compared with other high-volume specimen collection areas in the institution. A recent annual review showed a 0.12% rate of hard-stop errors (errors or labeling issues that required a process delay for resolution) for RFID GI/CRS specimens, versus 0.87% for non-RFID specimens from other areas.
Despite the clear success of the HF RFID project in reducing errors, the system had limitations. The passive HF tags required manual activation and had to be separately afﬁxed to the specimen container (in addition to the specimen label), which required an estimated 4.5 to 6 hours per week of staff time. Furthermore, the combined cost of the HF RFID tag and traditional bar code label was approximately $1.00, which was a substantial labeling expense for an area collecting more than 40 000 specimens per year. Although passive HF tags have a theoretical range of 1.0 to 1.5 m, in our experience the practical read range was only »0.3 m. This required both staff handling and physical contact between the specimen RFID tag and the RFID reader for tags to be read. In addition, the software supporting the HF RFID tracking infrastructure required user input for each specimen, which prevented batch processing. Although the HF RFID implementation led to marked improvements in quality outcomes, many of the theoretical advantages of the RFID technology over bar coding were not fully realized in the implementation. As a result, and despite the clear effectiveness of the technology, cost and workﬂow complexity limited the expansion of the HF RFID program to other specimen collection areas.
In response to near miss events (temporarily lost but recovered specimens) or actual loss events involving irretrievable and irreplaceable pathology specimens, an institutionally supported specimen tracking and identiﬁca-tion initiative was formed at our academic medical center. The initiative resulted in a multidisciplinary task force to identify and implement a solution to improve the quality of specimen tracking. The group’s work ultimately led to institution-wide implementation of RFID-based specimen tracking for high-volume biopsy collection areas. Here, we report on this experience and the initial results of the project in a 6-month postimplementation period.