#Laboratory song verification#
Weekly comparability verification of various clinical chemistry tests using multiple instruments was prospectively performed at Seoul National University Bundang Hospital from January 2015 to June 2019.
We propose an easy and frequent periodic comparability verification method that is applicable to various clinical chemistry instruments for the harmonization of diverse tests performed at healthcare centers. The CLSI guidelines present only limited examples of various situations and methodologies, for which the solutions involve infrequent and complicated processes that are unsuitable for application in specific routine measurements. The clinical and laboratory standard institute (CLSI) provides guidelines (EP31-A-IR) for comparability verification within a single healthcare system however, it does not suggest universally accepted criteria or specific methodology for each laboratory. Laboratories should establish their own procedures to ensure results comparability within their individual systems.
#Laboratory song how to#
More economic and simpler within-laboratory harmonization or comparability verification methods are required to provide convincing and reliable outputs from large laboratories using multiple instruments.Ĭomparability of results assures that the examination of a measurand is consistent within a laboratory system, even if different methods and instruments are used however, there is currently no consensus on how to demonstrate such comparability. Step-wise protocols for standardization have been developed till date for only a few clinical tests, including cholesterol, creatinine, hormones, and glycohemoglobin. However, global standardization or harmonization of clinical laboratory results is currently limited by cost and labor-effectiveness, as well as various technical and environmental challenges, and Korea is no exception. Therefore, periodic comparability verification is necessary to provide clear and harmonized results from different instruments, regardless of the approaches used. If the instruments for a particular test are not harmonized, different measurement systems may yield biased results for the same sample, resulting in an increased risk of misinterpretation or malpractice. In large healthcare centers with multiple instruments, patient samples may be exposed to various laboratory test settings. Standardization and/or harmonization ensures the comparability and interchangeability of laboratory results and prevents physicians’ confusion and misinterpretation of laboratory results. Harmonization is used for numerous clinical laboratory measurement procedures that do not have a technically reasonable or commutable reference material and can be a practical solution for calibration traceability for various measurands that would otherwise be non-harmonized. As an alternative to standardization, harmonization encompasses the concept of achieving equivalent results without a CRM and/or RMP, which implies that results are comparable irrespective of the time and place. Owing to issues concerning cost, availability, and commutability of RMPs and CRMs, standardization cannot always be achieved in real-world practice. Standardization is the process of obtaining equivalent clinical results from different measurement procedures using a calibration method that is traceable to a reference measurement procedure (RMP) or certified reference materials (CRMs).
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