Harmonization Of Clinical Laboratory Test Results Introduction Background - AACC POSITION:

However, many harmonization includes the concepts standardization of the available reference materials are not suitable for (uniformity of test results based on relation to a use in calibration of routine test procedures primarily reference method) and harmonization (uniformity of due to inadequate commutability with patient samples test results when a reference method is not available). [...] AACC Laboratory Organizations is currently working with its domestic and international • Laboratory organizations should provide education partners to implement this recommendation by creating about the variability in laboratory test results the International Consortium for Harmonization of Clinical and the value of harmonizing these results to Laboratory Results. [...] Improving the harmonization of • As regulatory requirements evolve, agencies should test results is critical to improving the quality and value emphasize and promote harmonized test results. [...] • Although nothing should be done to compromise Electronic Health Records patient safety, worldwide regulatory processesshould be streamlined and harmonized to expedite One of the important healthcare goals of the past decade recalibration of regulated IVD medical devices has been to increase the use of electronic health records to achieve harmonized test results based on (EHRs) by providers. [...] • The specificity characteristics of different measurement procedures for the target measurand should be Considerations sufficient to support the use of uniform interpretivecriteria for test results from different procedures.