The Empower project – a new way of assessing and monitoring test comparability and stability
Autor: | Katleen Van Uytfanghe, Dietmar Stöckl, Linde A.C. De Grande, Kenneth Goossens, Linda M. Thienpont |
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Rok vydání: | 2015 |
Předmět: |
Quality Control
AMINOTRANSFERASE Percentile bias Quality management Standardization SINGLE-DONATION SERA ACCURACY media_common.quotation_subject Concordance median Clinical Biochemistry Medical laboratory 37-DEGREES-C ALBUMIN Specimen Handling CATALYTIC ACTIVITY CONCENTRATIONS Freezing Medicine and Health Sciences Humans Medicine Quality (business) LONG-TERM STABILITY LABORATORY MEDICINE media_common analytical/population variation drift business.industry Biochemistry (medical) Comparability quality indicators shift General Medicine Clinical Laboratory Services STANDARDIZATION moving median outpatients Test (assessment) Risk analysis (engineering) business ENZYMES Blood Chemical Analysis |
Zdroj: | CLINICAL CHEMISTRY AND LABORATORY MEDICINE |
ISSN: | 1437-4331 1434-6621 |
Popis: | Manufacturers and laboratories might benefit from using a modern integrated tool for quality management/assurance. The tool should not be confounded by commutability issues and focus on the intrinsic analytical quality and comparability of assays as performed in routine laboratories. In addition, it should enable monitoring of long-term stability of performance, with the possibility to quasi “real-time” remedial action. Therefore, we developed the “Empower” project.The project comprises four pillars: (i) master comparisons with panels of frozen single-donation samples, (ii) monitoring of patient percentiles and (iii) internal quality control data, and (iv) conceptual and statistical education about analytical quality. In the pillars described here (i and ii), state-of-the-art as well as biologically derived specifications are used.In the 2014 master comparisons survey, 125 laboratories forming 8 peer groups participated. It showed not only good intrinsic analytical quality of assays but also assay biases/non-comparability. Although laboratory performance was mostly satisfactory, sometimes huge between-laboratory differences were observed. In patient percentile monitoring, currently, 100 laboratories participate with 182 devices. Particularly, laboratories with a high daily throughput and low patient population variation show a stable moving median in time with good between-instrument concordance. Shifts/drifts due to lot changes are sometimes revealed. There is evidence that outpatient medians mirror the calibration set-points shown in the master comparisons.The Empower project gives manufacturers and laboratories a realistic view on assay quality/comparability as well as stability of performance and/or the reasons for increased variation. Therefore, it is a modern tool for quality management/assurance toward improved patient care. |
Databáze: | OpenAIRE |
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