Schaller K H, Angerer J, Lehnert G
Institut für Arbeits- und Sozialmedizin und Poliklinik für Berufskrankheiten, Universität Erlangen-Nürnberg, Federal Republic of Germany.
Int Arch Occup Environ Health. 1991;62(8):537-42. doi: 10.1007/BF00381105.
Due to a technical rule for dangerous agents (TRGS 410), issued by the Ministry of Labor in the Federal Republic of Germany in 1979, toxicological analyses in biological materials must be carried out under conditions of "statistical quality control". This quality-control scheme provides internal and external control programmes. For internal quality control, the results of many years of experience with five commercially available control specimens and one "home-made" control have been evaluated. The control samples showed good, comparable results over a long period. Except in a few cases, there was good agreement between our results and the assigned values. Since 1982, the German Society of Occupational Medicine has offered eight intercomparison programmes for external quality. In samples from 80-90 laboratories, 6 metals in blood and around 20 inorganic and organic parameters in urine in 2 concentration adjustments have been analysed. Successful participation was certified if both results obtained for one parameter were within the tolerance range (assigned value +/- 3 SD). The average success rate was around 60%.
根据德意志联邦共和国劳动部1979年发布的危险物质技术规则（TRGS 410），生物材料中的毒理学分析必须在“统计质量控制”条件下进行。该质量控制方案提供内部和外部控制程序。对于内部质量控制，已对多年来使用五种市售对照样本和一种“自制”对照的经验结果进行了评估。对照样本在很长一段时间内显示出良好的、可比的结果。除少数情况外，我们的结果与指定值之间有很好的一致性。自1982年以来，德国职业医学协会提供了八项外部质量比对计划。对来自80 - 90个实验室的样本，分析了血液中的6种金属以及尿液中2种浓度调节下的约20种无机和有机参数。如果一个参数获得的两个结果都在公差范围内（指定值±3标准差），则认证为成功参与。平均成功率约为60%。
