Practical solution for control of the pre-analytical phase in decentralized clinical laboratories for meeting the requirements of the medical laboratory accreditation standard DIN EN ISO 15189

Uberörtliche Gemeinschaftspraxis für Laboratoriumsmedizin Leverkusen-Köln-Wenrath, Standort Köln, Labor Laser und Kollegen, Cologne, Germany.
Clinical laboratory (Impact Factor: 1.13). 02/2007; 53(3-4):211-5.
Source: PubMed


This report was written in response to the article by Wood published recently in this journal. It describes a practical solution to the problems of controlling the pre-analytical phase in the clinical diagnostic laboratory. As an indicator of quality in the pre-analytical phase of sample processing, a target analyte was chosen which is sensitive to delay in centrifugation and/or analysis. The results of analyses of the samples sent by satellite medical practitioners were compared with those from an on-site hospital laboratory with a controllable optimized pre-analytical phase. The aim of the comparison was: (a) to identify those medical practices whose mean/median sample values significantly deviate from those of the control situation in the hospital laboratory due to the possible problems in the pre-analytical phase; (b) to aid these laboratories in the process of rectifying these problems. A Microsoft Excel-based Pre-Analytical Survey tool (PAS tool) has been developed which addresses the above mentioned problems. It has been tested on serum potassium which is known to be sensitive to delay and/or irregularities in sample treatment. The PAS tool has been shown to be one possibility for improving the quality of the analyses by identifying the sources of problems within the pre-analytical phase, thus allowing them to be rectified. Additionally, the PAS tool has an educational value and can also be adopted for use in other decentralized laboratories.

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    • "It is important to mention, however, that an inverse trend was observed for the relative frequency of preanalytical errors, where the error rate has increased from to 68 to 87% in 10 y (p b 0.001, by χ 2 test) [15], meaning that major efforts should still be placed on those procedures, especially the manually intensive ones, which are performed before the sample reaches the laboratory. 3. Governance of the preanalytical phase: the road to improvement As for any other type of medical errors, implementation of a total quality management system is the most effective road to improvement [8] [16] [17], by encompassing a multifaceted strategy which ultimate target is to decrease the uncertainty inherent to this process. The preanalytical phase begins with the formulation of a reliable clinical suspicion, the request of the most appropriate investigations to make (or exclude) a potential diagnosis, and continues with collection, transportation, treatment, handling and storage of the biological samples. "
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