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71.
72.
On September 1, 1992 all testing sites in the United States were required to comply with the Clinical Laboratory Improvement
Amendments of 1988 (CLIA'88). These regulations, based on both total quality management (TQM) and continuous quality improvement
(CQI) principles, reshaped the environment for more than 90% of laboratories. CLIA'88 represented a revolutionary change by
imposing universal, uniform regulations based on test complexity for all sites examining materials derived from the human
body for the purpose of providing information for the diagnosis, prevention, or treatment of disease. CLIA'88 specifies minimum
requirements for personnel, quality control, and proficiency testing (PT). In addition, laboratories are required to follow
manufacturers' directions and comply with other specified good laboratory practices. PT is mandated for most of the frequently
run analyses and quality assurance requirements integrate the principles of CQI as well as TQM into the regulatory process.
Biannual inspection is integral to CLIA'88, however, laboratories can choose other federally approved ("deemed") professional
organizations, such as the Commission on Office Laboratory Accreditation, the College of American Pathologists, or the Joint
Commission on Accreditation of Healthcare Organization, having standards that meet or exceed those of CLIA'88. CLIA'88 has
still not been finalized. This article discusses the impact and changes since CLIA's implementation in 1992.
Received: 5 October 1998 · Accepted: 20 October 1998 相似文献
73.
Günter Block Dieter Hirschfeld Ilse-Marie Lichtenauer Annette Pohl 《Mikrochimica acta》1992,107(3-6):279-282
The aim of the first part of the paper is to give some advice for the faultless metallographic preparation of vacuum plasma sprayed coatings. Several coating/substrate combinations using metals, alloys and ceramics were investigated to derive some general rules. The second part deals with a preparation technique for cross-sections- of physical vapour deposition coatings. This technique was optimized for TiN and Ti(C, N) coatings on hardmetals which were examined in an analytical transmission electron microscope. 相似文献
74.
An electrochemical biosensor for the specific detection of short DNA sequences from the E. coli pathogen is described. This hybridization device relies on the immobilization of a 25-mer oligonucleotide probe, from the E. coli lacZ gene, onto a screen-printed carbon electrode. Chronopotentiometric detection of the Co(bpy)3+3 indicator is used for monitoring the hybridization event. Numerous variables of the assay protocol, including those of the probe immobilization step, the hybridization event, and the indicator association/detection, are characterized and optimized. Hybridization times of 2- and 30-min are sufficient for detecting 300- and 50 ng/mL, respectively, of the E. coli DNA target. Applicability to analysis of untreated environmental water samples is illustrated. Such single-use electrochemical sensors hold great promise for decentralized environmental and food testing for the E. coli pathogen. 相似文献
75.
76.
The complexity of different quality standards can, in principle, be covered by different approaches and strategies. In-depth
process mapping of quality control (QC) work streams was used by the analytical laboratories of Lonza AG to show up the principle
differences in being compliant to different quality systems. The results identified two main drivers for all necessary actions:
process-related activities and infrastructure-related activities. In addition, a clear indication of the economic impact of
these driving forces was gained, which led the laboratories to decide on a process-oriented approach. This approach has the
advantage of being able to reflect the different demands of different quality assurance (QA) regulations within the same QC
organizational structure. Following the process helps avoid unnecessary efforts in analytical work and represents a very economical
approach, at the same time, providing high flexibility to react to different QA or customer demands.
Received: 5 July 2002 Accepted: 12 November 2002
Acknowledgements The process-oriented approach resulted from many, very challenging discussions for which I would like to thank the staff
of my organization (Analytics & QC), especially, the QA staff and the LIMS team.
Presented at Analytica Conference, 23–26 April 2002, Munich, Germany
Correspondence to B. Ciommer 相似文献
77.
Corrado Di Natale Manuela Zude-SasseAntonella Macagnano Roberto PaolesseBernd Herold Arnaldo D’Amico 《Analytica chimica acta》2002,459(1):107-117
Visual aspect and aroma are among the most important features of fruit that determine consumer preferences. Electronic nose and spectroscopic techniques have shown positive results in evaluating some basic analytical parameters of fruit and global features such as the cultivar.In this paper, we illustrate and discuss a study aimed at evaluating the improvement derived by the fusion of visible spectra and electronic nose data. These experiments were performed on a population of yellow peaches belonging to two cultivars. Each sample was measured by visible optical spectroscopy and by electronic nose. In addition, a number of reference parameters were also measured by conventional destructive methodologies.Collected data were analysed individually and then fused together in order to classify the two cultivars and to estimate the reference parameters. Data fusion was performed building the outer product matrix for each measurement. The set of matrices was then successively unfolded and analysed by conventional chemometrics tools.Results were improved using outer products, for instance in classification average percentage errors of 25, 10, and 7 for electronic nose, spectra, and outer product, respectively was achieved. Regression analysis provides the evidence of a substantial orthogonal appearance of the datasets, which offer former hidden information on fruit classification. 相似文献
78.
通过仿真计算分析了激光在光束控制系统通道内传输所产生的热效应及其对远场光束质量的影响。激光传播由近轴波方程描述,用快速傅里叶变换技术求解;激光热效应引起的流场密度变化采用完全Navier-Stokes方程计算。计算给出了不同波长、不同吸收系数条件下的远场光斑情况。计算结果表明,在典型的工作条件和状态下,较高能量激光在光束控制系统通道内产生的热效应影响不容忽视,它会明显降低远场目标处的能量集中度,增大光斑的发散。 相似文献
79.
80.
A method employing ultra‐high performance liquid chromatography–tandem mass spectrometry (UHPLC–MS/MS) for determination of eight components including ferulic acid, senkyunolide A, butylphthalide, ligustilide, butylidenephalide, senkyunolide I, senkyunolide H and levistolide A in Angelica sinensis was established. The separation was carried out using a Waters ACQUITY UHPLC BEH C18 column with gradient elution with 0.1% formic acid aqueous and acetonitrile at a flow rate of 0.4 mL/min. Good linearity was attained with R2 of 0.9983–0.9998 in wide concentration ranges. The method had limit of detection (LOD) and quantitation (LOQ) in the range of 0.42–6.98 ng/mL and 1.39–23.28 ng/mL, respectively. Intra‐ and inter‐day precisions varied with relative standard deviations (RSDs) from 0.33% to 0.88% and 0.37% to 1.04%, respectively. Moreover, the average recoveries were in a satisfactory range of 92.7%–102.1% with RSDs of less than 3.60%. Finally, the method was successfully applied to analyze 19 batches of A. sinensis samples grown in Min County, Gansu province, China, as well as that collected in other regions. The findings indicated that the established method is reliable and may thus be applied as a powerful tool for qualitative and quantitative analysis of components in A. sinensis, which has its implications in quality control of A. sinensis. 相似文献