LIMS and Positive Sample ID: Reducing Irreversible Medical Errors

Reducing Irreversible Medical Errors

Errors occur every day in every healthcare facility worldwide, and sometimes these errors prove fatal. Sample and Specimen identification errors are unfortunately more frequent that you would believe, and have been reported as the most common laboratory error. While the introduction of barcoding has greatly improved the quality of patient specimen analysis¹, studies have shown that 31.6% to 75% of laboratory errors take place during the pre-analytical stage².  This has become such a widespread issue that the US Centers for Disease Control have created an initiative on Improving Quality in Laboratory Medicine, named Laboratory Medicine Best Practices (LMBP). The initiative has four primary aims:

1. develop and apply transparent evidence-based methods to review quality improvement practices,
2. conduct reviews of the effectiveness,
3. provide a central source of information on the findings (comparative effectiveness) and
4. facilitate a network for the exchange of information on effectiveness of laboratory medicine (share the data with all of those involved in sample and specimen analysis and Positive ID).³

Positive identification is evidence proving that the sample or specimen is accurately identified and that it is established and recognized in the “system”– a LIMS (Laboratory Information Management System) or a LIS (Laboratory Information System).

In today’s laboratory environment, many assume that sample and specimen tracking is solid, in that all samples and specimens are properly and accurately/correctly identified for rapid analysis, management, and storage. In reality, there is quite a bit of room for improvement. Many laboratories still use hand written labels (with potential transcription errors) or pre-printed labels (with challenges such as numbers not being unique and being recycled).

As laboratories deal with growth in sample/specimen volume, they can no longer keep up with handwriting sample labels and then must turn to automated label generation. This will quickly improve efficiency and accuracy. Automated labels also solve the problem of lost or missing samples, freeing up the laboratory team to focus on the actual laboratory work. Printed barcodes can be quickly and accurately identified (scanned) with hand held scanners for easy management, tracking, and storage of samples.

LIMS’ barcoding feature can prevent serious errors, many of which cannot be undone. Positive ID can positively affect error rates like the estimated 3,400 surgery site errors the US saw in 2020⁴. Here are only a few examples of errors that occurred and their impact:

• Breast milk being mislabeled and a baby was given breast milk from a different mother– a mother infected with Hepatitis C.
• Wrong site surgery, cataract surgery was done on the incorrect eye, also incidences of the wrong patient surgery.
• In another case, a pathology laboratory mixed up the specimens and histological analysis and the incorrect patient had his prostate removed⁴.

These are just a few examples of the importance of Positive ID. In many cases the results are irreversible, underscoring the importance of correct specimen and sample identification. This requires implementation of a Positive ID system, with training, along with Standard Operating Procedures (SOPs) that clearly define the process along with the steps to take if a mistake is found.

LIMS feature electronic barcoding, providing a positive means to establish identification and linkage of laboratory specimens, patients, and laboratory testing results. LIMS also offer audit trails throughout the entire testing process (including test ordering, specimen collection, specimen acceptance and confirmation, analysis and testing, and result reporting).

References

1. Snyder SR, Favoretto A, Derzon J, Christenson C, Kahn S, Shaw C, Baetz RA, Mass D, Fantz CR, Raab SS, Tanasijevic MJ, and Liebow E. Effectiveness of Barcoding for Reducing Patient Specimen and Test Identification Errors: A Laboratory Medicine Best Practices Systematic Review and MetaAnalysis. Clin Chem. 2012; 45(13-14):988-998.
2. Bonini, P.; Plebani, M.; et al. Errors in laboratory medicine. Clin Chem. 2002, 48, 691–8.
3. Laboratory Medicine Best Practices Effective practices for reducing patient specimen and laboratory testing identification errors in diverse hospital settings (abbreviated). https://www.cdc.gov/labbestpractices/pdfs/cdc_barcodingsummary.pdf
4. WRONG SITE, WRONG PERSON SURGERIES AMONG TOP SERIOUS 2020 MEDICAL ERRORS, by Robert Painter, Painter Firm Law April 19th

‍