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ISO 15189 in focus: How well is your laboratory prepared for the pre-analytics requirements?

by | Nov 19, 2024 | Corporate News

Blood sampling is a particularly critical step in pre-analytics. It is not only important to take the blood sample correctly, but also to check patient data carefully and document all relevant information about the sample collection precisely. Errors in this phase can have serious consequences for the sample quality and thus influence the diagnosis or treatment. The most common problems encountered here are incorrectly filled tubes (13 %), incorrect patient data (9 %), unsuitable containers (8 %) and empty (7 %) or missing tubes (3 %).2

“The susceptibility to errors in pre-analytics is particularly high due to the lack of standardized systemic solutions,” summarizes Dr. med. Johannes Kruppenbacher, laboratory owner, Center for Blood Coagulation Disorders and Transfusion Medicine in Bonn. Digital solutions for sample tracking and documentation can help to reduce this error rate by enabling standardized and automated data collection. The use of such systems ensures that every step of the sample collection process is recorded and documented.

Digitization as the key to error reduction: A look at the case study of CBT Bonn

Roche has conducted a case study in cooperation with Smart4Diagnostics (S4DX) and the Center for Blood Coagulation Disorders and Transfusion Medicine (CBT) in Bonn to evaluate the benefits of digital pre-analytics solutions. S4DX develops digital tools for sample collection, identification and documentation. navify® Sample Tracking seamlessly integrates such partner solutions into the laboratory IT and the laboratory information system (LIS). This combination enables end-to-end sample tracking – from the time of collection to transportation and analysis in the laboratory.

Before the introduction of digital solutions, the CBT had a manual process for sample processing. Blood collection was organized using barcodes and handwritten documentation, which was then transferred to the LIS by qualified personnel. This analog approach led to high personnel costs, required a lot of time and was also prone to errors.

After implementing the digital solutions, CBT was able to significantly improve the transparency and efficiency of sample management. The entire process from blood collection to the transfer of samples to the laboratory was digitally mapped. The information recorded included the sample ID, the time of collection, patient data and specific quality characteristics such as fill level and tube suitability. This information was transferred directly into the LIS, minimizing errors and delays that can occur with manual entry.

Future-proof and ISO-compliant: digital solutions optimize pre-analytics

The digital recording and management of pre-analytics processes had a positive effect on laboratory quality in the case study. Improved transparency in sample tracking makes it easier to identify sources of error and develop preventive measures, thereby fulfilling the key requirements of ISO 15189 for accredited laboratories. This reduces the error rate and at the same time makes the process easier for employees. Dr. Philipp Westhofen, Laboratory Manager at CBT, emphasizes the benefits of traceability: “The transparency and tracking of sample pre-analysis improves the quality of laboratory procedures by improving the traceability of the sample path and reducing the number of incidents.”

Further information: https://www.roche.de/diagnostik/produkte-loesungen/digitale-loesungen/navify-sample-tracking/sample-tracking-centrum-fuer-blutgerinnungsstoerungen-und-transfusionsmedizin-bonn-cbt

1GreenS.F. “The cost of poor blood specimen quality and errors in preanalytical processes.” Clin Bio

2 Carraro P, Plebani M. “Errors in a stat laboratory: types and frequencies 10 years later.” Clin


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