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• A strong multidisciplinary organizational structure is necessary to drive consensus in selection and successfully implement point of care glucose meters across a large multi-hospital system. • Beyond the standard analytical laboratory evaluation, meter performance should be evaluated at the point of use, employing consensus error grids and defined acceptability criteria. • Structured end-user evaluation is as an essential element of the meter selection process which commonly includes the evaluation of cost, connectivity, indications for use, and ease of implementation. To select and standardize point-of-care (POC) glucose meters across a multi-hospital system. We formed a multidisciplinary POC glucose standardization working group including key stakeholders from each site. A set of selection criteria: usability, clinical and laboratory performance, indications for use, interface connectivity, ease of implementation and ongoing operational costs were used to develop a scoring schema to facilitate a consensus-driven selection process. Method comparison and consensus error grid evaluation against the clinically validated reference methods demonstrated that the analytical performance for all candidate meters was comparable for both the laboratory and clinical evaluation. However, Meter 1 ranked highest in usability evaluations, implementation and streamlined interface connectivity. The meter selection process and implementation were staggered across sites due to complexity of transitioning to a new manufacturer's meter and limitations in vendor support for training and ongoing troubleshooting of interface connectivity. Standardization of POC glucose meters in a large multi-hospital system is a complex undertaking requiring robust, multidisciplinary organizational structure both system-wide and locally, development of consensus-driven selection tools, usability evaluation by end-users, laboratory and clinical evaluation of the analytical performance, and a strong vendor-laboratory partnership during the implementation process. [ABSTRACT FROM AUTHOR]

• Objectives of IFCC working group on standardization of PCT assays. • Development of a higher-order reference method for PCT by IDMS. • Production of commutable EQA materials to evaluate the variability of PCT results. • Evaluation of the necessity and the feasibility for standardization of PCT assays. • Implementation of standardization of PCT assays if deemed needed and feasible. Procalcitonin (PCT) is an important biomarker for sepsis diagnosis and management. To date, there is no higher-order reference measurement procedure (RMP) and certified reference material to achieve global standardization of results and results traceability to the SI units. Although efforts have been made to harmonize PCT results, a number of comparison studies and external quality assessment (EQA) schemes show conflicting results regarding results comparability and to date, equivalence of PCT results across the assays remains questionable in absence of studies relying on commutable EQA materials. In this context, the IFCC initiated activities to fill these gaps through the creation of the working group on standardization of PCT assays that gathers experts from National Metrology Institutes, calibration laboratories, clinicians, biologists, EQA providers and assay manufacturers. Among the activities, a higher order RMP and commutable reference materials are under development to build a robust reference measurement system (RMS). A commutability study is being organized to identify EQA materials that are fit for purpose to reliably estimate the current comparability of PCT results. This work will make it possible to evaluate the necessity and the feasibility for establishing and maintaining a new RMS for PCT assays, if deemed necessary. [ABSTRACT FROM AUTHOR]

Abstract: Background: We introduce locally-smoothed (LS) median absolute difference (MAD) curves for the evaluation of hospital point-of-care (POC) glucose testing accuracy. Methods: Arterial blood samples (613) were obtained from a university hospital blood gas laboratory. Four hospital glucose meter systems (GMS) were tested against the YSI 2300 glucose analyzer for paired reference observations. We made statistical comparisons using conventional methods (e.g., linear regression, mean absolute differences). Results: Difference plots with superimposed ISO 15197 tolerance bands showed bias, scatter, heteroscedasticity, and erroneous results well. LS MAD curves readily revealed GMS accuracy patterns. Performance in hypoglycemic and hyperglycemic ranges erratically exceeded the recommended LS MAD error tolerance limit (5 mg/dl). Some systems showed acceptable (within LS MAD tolerance) or nearly acceptable performance in and around a tight glycemic control (TGC) interval of 80–110 mg/dl. Performance patterns varied in this interval, creating potential for discrepant therapeutic decisions. Conclusions: Erroneous results demonstrated by ISO 15197-difference plots must be carefully considered. LS MAD curves draw on the unique human ability to recognize patterns quickly and discriminate accuracy visually. Performance standards should incorporate LS MAD curves and the recommended error tolerance limit of 5 mg/dl for hospital bedside glucose testing. Each GMS must be considered individually when assessing overall performance for therapeutic decision making in TGC. [Copyright &y& Elsevier]