Recommendations for the application and the follow-up of quality controls in medical biology laboratories

被引：6

作者：

Giannoli, Jean-Marc ^{[1
]}

Albarede, Stephanie ^{[2
]}

Avellan, Thierry ^{[3
]}

Bouilloux, Jean-Pierre ^{[4
]}

Cartier, Regine ^{[5
]}

Cohen, Richard ^{[6
]}

Colard, Nathalie ^{[7
]}

Essemilaire, Luc ^{[8
]}

Galinier, Jean-Louis ^{[9
]}

Kuentz, Mathieu ^{[10
]}

Paris, Mickael ^{[11
]}

Portugal, Henri ^{[12
]}

Scherrer, Florian ^{[13
]}

Siest, Jean-Pascal ^{[14
]}

Vassault, Anne ^{[15
]}

Vialle, Jean-Michel ^{[16
]}

机构：

[1] LABAC, Dyomedea Neolab, Lyon, France

[2] CTCB, Toulouse, France

[3] LABAC, HIA Lavevan, Marseille, France

[4] LABAC, LxBIO, Rodez, France

[5] HCL, Probioqual, Lyon, France

[6] Probioqual, Lyon, France

[7] LABAC, Lab Colard, Fresnes Sur Escaut, France

[8] LABAC, Montauban, France

[9] CTCB, Lab Clin Pasteur, Toulouse, France

[10] CH Aurillac, SFBC, Aurillac, France

[11] LABAC, Cerballiance Bourgogne, Dijon, France

[12] Univ Aix Marseille, AP HM, LABAC, Marseille, France

[13] LABAC, Synlab Vallee Rhone, Roussillon, France

[14] Biol Prospect, Villers Les Nancy, France

[15] Asqualab, Paris, France

[16] LABAC, Lab Vialle, Bastia, France

来源：

ANNALES DE BIOLOGIE CLINIQUE | 2019年 / 77卷 / 05期

关键词：

risk analysis; internal quality control; external quality assessment; uncertainty; WORKING GROUP RECOMMENDATIONS; AVERAGE; LIMITS; ERROR; RISK;

D O I：

10.1684/abc.2019.1481

中图分类号：

R446 [实验室诊断]; R-33 [实验医学、医学实验];

学科分类号：

1001 ;

摘要：

The recommendations that we formulate in this document come from LABAC, SFBC and FAEEQ. They describe the different steps from the initial application of quality controls, based on risk analysis: the changes of reagent batches or internal quality controls (IQC) batches, the course when IQC are not in accordance with references, the choice of external quality evaluation and the interpretation of its results, the comparability of results obtained in several analysers used in the same laboratory. Lastly, measurement uncertainty, robustness of methods and specificities of near-patient biology and rapid tests are described. Note that these recommendations cannot develop all cases that we could find in laboratories. It remains necessary to carry out an objective strategy, supported with documentary evidences.

引用

页码：577 / 597

页数：21

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