CEO SUMMARY: Standardization of bar code labels is a concept whose time has come. After implementing CLSI standard AUTO12-A, first-mover clinical labs report fewer specimen identification errors, a reduction of costs associated with specimen handling errors, and a boost in lab productivity. Moreover, accrediting bodies such as The Joint Commission and the College of American Pathologists are moving to require labs to comply with the bar code label standard in coming years.
ACROSS THE NATION, all clinical labs and pathology groups now have the opportunity to institute a simple change in lab operations that can unlock major improvements in tracking specimens, reducing specimen ID errors, and boosting the productivity of the laboratory.
That simple change is to adopt the universal standard for bar code labels that was developed by advisors from the clinical lab industry and is published by the Clinical and Laboratory Standards Institute (CLSI) in Wayne, Pennsylvania. The standard is “AUTO12-A, Specimen Labels: Content and Location, Fonts, and Label Orientation.”
Implementing the Standard
There are examples of first-mover and early-adopter labs that have implemented this bar code label standard. These clinical lab organizations acknowledge that adoption of the standardized bar code label has unlocked new and continuing opportunities to improve the performance of their labs.
Benefits include a reduction in the number of errors associated with specimen ID and improvements in specimen handling, tracking, and storage. In turn, laboratory costs have been reduced, and the accuracy and quality of lab test services delivered to referring physicians and their patients has improved.
There is a message to the wider clinical lab and anatomic pathology profession from these first-mover labs. The adoption and use of the standardized bar code label requires a small up-front investment, but then becomes the “gift that goes on giving.”
Further, at a time when lab budgets are shrinking even as the pressure increases on labs to continuously reduce errors, the minor cost to adopt the standardized bar code label enables labs to more easily achieve cost savings and a reduction of errors.
It may surprise most clients and readers of THE DARK REPORT to learn that the CLSI effort to standardize bar code labels has been around for a very long time. As early as 2005, CLSI had proposed such a standard.
“The latest approved version of the standard was issued by CLSI in 2011,” stated Charles D. Hawker, Ph.D., MBA, FACB, the Scientific Director, Automation and Special Projects, for ARUP Laboratories in Salt Lake City, Utah. “CLSI has said all labs should comply with the standard by April 29, 2014. If labs don’t act now, they may need to engage in considerable last-minute activity.
“This standard was needed because misidentified or mislabeled specimens happen in laboratories with a greater frequency than what would represent good patient care,” explained Hawker. He chaired the CLSI committee that prepared the standard. “A variety of labels also impedes the ability of labs to standardize and process specimens quickly.”
Considered an expert on total labor tory automation, Hawker has published several peer-reviewed studies demonstrating that use of non-standardized bar code labels on patient specimens contributes to a surprisingly high rate of errors. One study was published by Clinical Chemistry in 2010, titled “Bar Codes May Have Poorer Error Rates Than Commonly Believed.” (CC 56:10—1513–1514, 2010.)
Eliminating Standard Options
“Published references cited in the CLSI standard show mislabeling error rates in the United States range from 0.1% to 5%,” he commented. “Among the published references that were cited, one report revealed an error rate of nearly 1 per 1,000 in 147 participating clinical laboratories. Another report in the cited sources indicated a mislabeled error rate of 1.12% on blood bank specimens. This latter value is astoundingly high!”
In one report published in 2005, the average cost of a misidentified specimen was $712. “This did not include immeasurable costs, such as patient anxiety and discomfort and the delays in diagnosis and treatment,” observed Hawker. “This amount also does not include the consequential costs, such as those for any possible ensuing litigation for actual incurred patient harm.
“A conservative estimate for the total cost of mislabeled specimens was $280,000 per million specimens tested,” he continued. “This amount does not include litigation or settlement expenses. This estimate comes from multiplying the average cost of $712 per mislabel incident times a low published incidence of mislabeled specimens of 0.039%, according to a one report.
“When laboratory employees constantly have to readjust their focus to find patient names in different locations on the labels—or if those names appear in inconsistent fonts and formats—the likelihood of errors rises,” he added. “Therefore, it stands to reason that institutions that implement the bar code label standard will benefit from lower rates of errors resulting from mislabeled specimens.
“If these benefits, ranging from saving costs and reduced errors to improved patient care, are not enough to justify adoption of the standard for bar code labeling, there is another reason for labs to comply with the standard,” declared Hawker. “It will become a requirement for lab licensure and/or accreditation.
“For example, in December 2012, The Joint Commission, which inspects all hospitals in the United States, reported that it intended to list the bar code label standard as a reference in its Prepublication Requirements document,” he noted. “The bar code label standard also will be studied by the College of American Pathologists (CAP) next year (2014) or in 2015 with a goal of including it in the checklist.
Bar Code Label Standard
“The purpose of the standard is to serve as a precise typographical map for specimen labels,” explained Hawker. “The standard specifies the horizontal and vertical rule locations, font types, and font sizes on all specimen labels for certain essential, human-readable elements. These elements include the patient’s name, a unique secondary identifier, the patient’s date of birth, the specimen collection date and time, and the specimen collector’s identification.
“One feature of the standard is a suggested format for doctor’s offices and other providers who handwrite labels for specimens to be submitted to a laboratory,” concluded Hawker. “With this established standard in place, labs now have the opportunity to use it to further reduce errors and improve patient safety.”
Is It Time to Rethink the Lowly Bar Code Label? Opportunity for Labs to Spend a Little, Get a Lot
ATTENTION ALL LEAN AND SIX SIGMA PRACTITIONERS in clinical labs and anatomic pathology groups! It is now time to reconsider the lowly bar code label and its contribution to unnecessary and expensive errors as a way to reduce errors and improve the productivity of laboratory automation systems.
It is a common perception within labs that, by using bar codes, a high level of accuracy results when identifying specimens and tracking them through the laboratory. This is certainly true when compared to manual handling of specimen tubes. But bar code labels have their own failings.
First, there is the quality of the bar code label. The label itself may not take the printing in a way that allows readers to accurately scan that label. The label printer may be using ink that does not transfer well to the label.
Of course, the label printer may be malfunctioning. Deferred maintenance of the label printer can cause it to produce bar code labels that may appear acceptable to the human eye, but that fail or are misread when scanned by mechanical label readers.
The next common source of errors is literally the “Tower of Babel” caused by bar code labels flowing into the lab from multiple sources with different formats.
This fact was described by the committee for the Clinical and Laboratory Standards Institute (CLSI) that designed a standard for bar code labs. “A collection of labels from different laboratories provided by one committee participant showed a variety of formats and fonts,” said Charles D. Hawker, Ph.D., Scientific Director, Automation and Special Projects, for ARUP Laboratories in Salt Lake City, Utah. Hawker chaired the committee for CLSI.
“Some specimen labels had the patient name on the first line, some on the second line, and some on the third or fourth,” he said. “Sometimes, the patient name was left-justified and sometimes it was in the center. Sometimes it was above the bar code and sometimes it was below.
“There were even some specimen labels on which the name was turned 90 degrees to the length of the tube, sometimes toward the top of the tube, and sometimes toward the bottom of the tube,” explained Hawker. “Such variety was not useful and contributes to errors within the laboratory.”
Given this information, it would be timely for all process improvement lead- ers in labs across the country to consider adoption of the CLSI standard AUTO12-A for bar code labels. The cost to implement the software and formatting changes that support the bar code label standard is minimal.
In return, use of the standard bar code label format eliminates one more source of variability in lab automation and work processes. It positions the lab to pursue the goal of Six Sigma quality across each individual work process within the laboratory.