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L'intérêt des cartes de contrôle en biologie médicale est de disposer d'un plan de contrôle interne de qualité (CIQ) permettant de s'assurer de la stabilité des méthodes utilisées pour la mesure de paramètres biologiques. Le suivi des résultats de CIQ au quotidien permet de valider la stabilité des méthodes entre deux exercices d'évaluation externe de la qualité (EEQ) qui vali-deront, eux, l'exactitude des résultats rendus. Cet article décrit les principes de deux approches de gestion des résultats de CIQ : l'approche conven-tionnelle classiquement utilisée dans les laboratoires de biologie médicale et l'approche bayésienne nouvellement implémentée. The interest of medical biology control charts is to have an internal quality control plan (IQC) to ensure the stability of methods used for measuring biological parameters. The daily quality control monitoring allows to validate the stability between two external quality assessment exercises (EQA) which will validate the accuracy of the results. This paper describes the principles of two approaches to manage internal quality controls: the conventional approach traditionally used in medical biology laboratories and the newly implemented Bayesian approach. [ABSTRACT FROM AUTHOR]

It is important that a clinical laboratory has implemented appropriate procedures for quality control, which includes both internal quality control (IQC) and external quality assessment (EQA) with the common goal to detect systematic errors and random errors. It is the case for both the Hemohub® Bayesian tools for IQC results interpretation and the ECAT EQA optimised bivariate z-scores analysis. On a concrete case study, we demonstrate both the higher sensitivity and specificity of optimised bivariate z-scores analysis than the univariate approach. The Bayesian IQC results interpretation like the ECAT analysis confirmed the explicit conclusion i.e. an increase of the random error corresponding to the increase of the inter assay coefficient of variation (CV) at the date of EQA samples runs. Improvement of repaired dysfunction could be then daily observed on IQC results and then confirmed on EQA results thanks to the complementarity of the two approaches.

Abstract Background To decentralize point-of-care early infant diagnosis (POC EID), task shifting to cadres such as nurses is important. However, this should not compromise quality of testing through generating high rates of internal quality control (IQC) failures and long result turnaround times. We used data from a POC EID project in Zimbabwe to compare IQC rates and result return to caregivers for samples run on a POC EID technology (Alere q HIV 1/2 Detect) between nurses and laboratory-trained personnel to assess effects of task shifting on quality of testing. Methods This cross-sectional retrospective study used data from all 46 sites (10 hub and 36 spoke sites in Zimbabwe that piloted POC EID for routine clinical use from December 2016 to June 2017). IQC failure rates were downloaded from each POC EID platform and exported to excel to analyze IQC failure rates by type of operator. Turnaround time (TAT) from sample collection to issuing of results to caregiver was extracted from the EID test request form and uploaded into a project specific Excel-based database for analysis. Results A total of 1847 tests were conducted by 45 testers (12 laboratory-trained and 33 non-laboratory-trained personnel), including 165 errors. There were no significant differences in IQC failure rates between non-laboratory testers (137 [9.2%] of 14830 tests) and specialized laboratory-trained (28 [7.7%] of 364 tests; p = 0.354). Over time, IQC failure rates for both non-laboratory (χ 2 = 18.5, p < 0.000) and specialized laboratory-trained testers (χ 2 = 8.7, p < 0.003) decreased significantly. There were similar proportions of clients who were issued with results between samples processed by non-laboratory testers (1283 [98.9%] of 1297 tests) and samples processed by specialized laboratory-trained testers (315 [98.7%] of 319 tests; p = 0.790). The overall median turnaround time from sample collection to receipt of results by caregiver for samples run by laboratory-specialized testers was not statistically different from samples run by non-laboratory-specialized testers (1 day [IQR 0–3] versus 0 days [IQR 0–2]; p = 0.583). Conclusions Similar IQC failure rates and TATs between non-laboratory and specialized laboratory-trained operators suggest that non-specialized laboratory-trained personnel can perform POC EID equally well as specialized laboratory personnel.

Background: To decentralize point-of-care early infant diagnosis (POC EID), task shifting to cadres such as nurses is important. However, this should not compromise quality of testing through generating high rates of internal quality control (IQC) failures and long result turnaround times. We used data from a POC EID project in Zimbabwe to compare IQC rates and result return to caregivers for samples run on a POC EID technology (Alere q HIV 1/2 Detect) between nurses and laboratory-trained personnel to assess effects of task shifting on quality of testing.Methods: This cross-sectional retrospective study used data from all 46 sites (10 hub and 36 spoke sites in Zimbabwe that piloted POC EID for routine clinical use from December 2016 to June 2017). IQC failure rates were downloaded from each POC EID platform and exported to excel to analyze IQC failure rates by type of operator. Turnaround time (TAT) from sample collection to issuing of results to caregiver was extracted from the EID test request form and uploaded into a project specific Excel-based database for analysis.Results: A total of 1847 tests were conducted by 45 testers (12 laboratory-trained and 33 non-laboratory-trained personnel), including 165 errors. There were no significant differences in IQC failure rates between non-laboratory testers (137 [9.2%] of 14830 tests) and specialized laboratory-trained (28 [7.7%] of 364 tests; p = 0.354). Over time, IQC failure rates for both non-laboratory (χ2 = 18.5, p < 0.000) and specialized laboratory-trained testers (χ2 = 8.7, p < 0.003) decreased significantly. There were similar proportions of clients who were issued with results between samples processed by non-laboratory testers (1283 [98.9%] of 1297 tests) and samples processed by specialized laboratory-trained testers (315 [98.7%] of 319 tests; p = 0.790). The overall median turnaround time from sample collection to receipt of results by caregiver for samples run by laboratory-specialized testers was not statistically different from samples run by non-laboratory-specialized testers (1 day [IQR 0-3] versus 0 days [IQR 0-2]; p = 0.583).Conclusions: Similar IQC failure rates and TATs between non-laboratory and specialized laboratory-trained operators suggest that non-specialized laboratory-trained personnel can perform POC EID equally well as specialized laboratory personnel. [ABSTRACT FROM AUTHOR]

Commercial Internal Quality Control (IQC) materials are used regularly nowadays by most laboratories for ensuring that their test results are accurate, and the equipment used for analysis is functioning optimally. IQC may be procured from the company supplying reagents for a closed system or from an unrelated vendor who is not involved in supplying the equipment or reagents (third-party controls). Most IQC for Complete Blood Count have a short shelf life of up to three months and often the company further restricts the usage to 2-3 weeks after opening the pack or for few hours after reconstitution for coagulation-based assays. Some simple methods can go a long way in increasing the shelf life and enable substantial cost cutting, as we have succeeded in our laboratory for hematology and coagulation. [ABSTRACT FROM AUTHOR]

In 2006, the French Food Safety Agency (AFSSA) started the second French Total Diet Study to assess exposure to essential and non-essential elements through dietary intake by analysing 1352 food samples. A total of 21 elements were analysed to date by Inductively Coupled Plasma Mass Spectrometry after closed vessel microwave digestion, in 660 samples corresponding to at half of the study. This work presents and discusses the results of the various internal quality controls (IQC) applied to ensure that the analytical procedure is correctly carried out, from digestion to analysis, and to enable analytical chemists to validate the results obtained. The whole IQC allows to estimate uncertainties according to elements and to select those that should be discarded from the study or only given as indicative values for elements that were not within defined quality limits. [ABSTRACT FROM AUTHOR]