基于物联网的医用耗材二级库管理

目的探讨基于物联网的医用耗材新型管理模式,以提高医用耗材管理效率,合理控制医院运营成本。方法运用医疗器械唯一标识（UDI）扫码技术,推行医用耗材新型管理模式,形成一套完整的医用耗材管理流程。结果医用耗材实现了从准入到使用的全流程追溯;可收费耗材采购量同比下降28%;患者均次使用耗材金额降低2%;平均领货周期同比下降15%。结论基于物联网的医用耗材二级库新型管理模式有助于提升医院的耗材管理水平。     

我国放射性惰性气体Kr、Xe监测体系的溯源现状

核爆炸试验和核电站的工作过程中都会产生放射性惰性气体,无论是研究核电站排出放射废气对环境的影响,还是监测核禁试或核应急事故,都需要对其产生的放射性惰性气体进行监测。本文分析了我国放射性惰性气体（Kr、Xe）监测现状,并对其计量溯源状况进行了总结,旨在发现其中存在的不足,为完善放射性惰性气体监测体系做出建议。     

Commutability and traceability: their repercussions on analytical bias and inaccuracy

The commutability of calibrators and accuracy control materials affects the traceable link between patient sample results and standards. We sought to identify the repercussions of commutability on various aspects of laboratory practice (calibration, control of bias and accuracy assessment) and to discover the solutions that can reduce the problems produced by non-commutability with presently available resources. Ten serum constituents, ten comparison procedures and 37 analytical procedures were studied. The information concerning accuracy and bias provided from materials found to be commutable in previous works was challenged with native serum results for each routine and reference method compared, using Passing–Bablok regression and decision limits derived from biological variation. We found that: (1) Use of commutable control materials did not assure reliable information on the bias (systematic component of analytical error) of analytical procedures, and (2) Results from native serum and commutable controls were very highly concordant, indicating that these materials provide a good indication of the inaccuracy (total analytical error) of results. We suggest that the performance of individual laboratories would be better evaluated by occasional use of native sera with values assigned by reference methods in EQAS schemes. Moreover, our findings support the idea that manufacturers should assign values to calibrators using reference methods and native sera to reduce matrix effects and promote traceability.     

福建灵芝高效薄层色谱鉴别及其在溯源中的应用

目的 本研究旨在建立福建灵芝高效薄层色谱方法,并对比福建产区与其他产区薄层的异同点,为灵芝药材在薄层溯源中的应用提供实验依据。方法 采用Merk HPTLC Silica gel 60预制板,氯仿-乙腈-甲醇-甲酸(13∶1.5∶0.2∶0.2)为展开剂,3%硫酸乙酸乙酯溶液显色,在紫外366 nm下检视,采用对照品比对鉴别薄层色谱条带。使用斑点条带数字化表征,对不同产区样品进行聚类分析。结果 高效薄层色谱共分离灵芝药材中17个条带,用对照品比对鉴定了其中11个成分,包括灵芝烯酸C(Rf₅=0.31)、灵芝酸C2(Rf₆=0.33)、灵芝酸I(Rf₇=0.35)、灵芝酸G(Rf₈=0.41)、灵芝酸A(Rf₉=0.44)、灵芝酸B(Rf₁₀=0.46)、灵芝内酯B(Rf₁₁=0.53)、3β,7β,15β-三羟基-11,15-二羰基-羊毛甾烷-8-烯-24→20内酯(Rf₁₂=0.56)、灵芝烯酸D(Rf     

临床检验量值溯源与参考系统

医疗卫生工作需要准确可比的检验结果，实现临床检验标准化的有效途径是建立和保证检验结果的计量学溯源性。溯源性通过一系列由不同等级测量程序和校准物实现的比较测量而建立，较低级别程序足够特异和校准物具有互通性是计量学溯源的前提。较高级别的测量程序和校准物称参考系统，参考系统需符合特定计量学要求，为此有关国际组织成立检验医学溯源联合委员会（JCTLM），鉴定现有国际参考测量程序、参考物质和参考实验室。总之，临床检验量值溯源问题已受到广泛重视，发展和应用参考系统将可能成为临床检验领域的重要课题。     

血清酶测定结果可溯源性研究

目的　通过对酶标准品的测定 ,探讨血清酶测定结果的可溯源性。方法　向参加研究的实验室 (50家 )各发放酶校准品 1支 ,各实验室用常规方法测定校准品 ,记录检验结果 ;计算校准品测定结果总体均值与标示值间的偏倚。结果　丙氨酸氨基转移酶 (ALT)、天门冬氨酸氨基转移酶(AST)、肌酸激酶 (CK)和乳酸脱氢酶 (LD)的测定结果均值与标准品标示值的相对偏差≤± 10 % ,分别为 6 3 % ,5 5% ,-5 9%和 -5 0 % ;碱性磷酸酶 (ALP)的实验室检测结果与标准品标示值间的相对偏倚为 -3 6 6% ,淀粉酶测定结果的实验室间CV为 2 9 2 %。结论　我国临床实验室对血清酶的测定结果有向国际标准溯源的基础     

Monte Carlo modeling provides accurate calibration factors for radionuclide activity meters

Accurate determination of calibration factors for radionuclide activity meters is crucial for quantitative studies and in the optimization step of radiation protection, as these detectors are widespread in radiopharmacy and nuclear medicine facilities. In this work we developed the Monte Carlo model of a widely used activity meter, using the Geant4 simulation toolkit. More precisely the “PENELOPE” EM physics models were employed. The model was validated by means of several certified sources, traceable to primary activity standards, and other sources locally standardized with spectrometry measurements, plus other experimental tests. Great care was taken in order to accurately reproduce the geometrical details of the gas chamber and the activity sources, each of which is different in shape and enclosed in a unique container. Both relative calibration factors and ionization current obtained with simulations were compared against experimental measurements; further tests were carried out, such as the comparison of the relative response of the chamber for a source placed at different positions.The results showed a satisfactory level of accuracy in the energy range of interest, with the discrepancies lower than 4% for all the tested parameters. This shows that an accurate Monte Carlo modeling of this type of detector is feasible using the low-energy physics models embedded in Geant4. The obtained Monte Carlo model establishes a powerful tool for first instance determination of new calibration factors for non-standard radionuclides, for custom containers, when a reference source is not available. Moreover, the model provides an experimental setup for further research and optimization with regards to materials and geometrical details of the measuring setup, such as the ionization chamber itself or the containers configuration.     

条形码在口腔医院高值耗材管理中的作用及意义

针对医用高值耗材传统管理模式存在的弊端,实行条形码管理是新形势下医院对高值耗材规范管理的必经之路。在＂军卫一号＂物资管理平台下开发条形码管理子系统,对高值耗材管理流程进行科学优化,可充分体现条形码管理的特点和优势。不但能够实现高值耗材与患者的一一对应关系,同时可以实现高值耗材出入库、计费和财务部门挂账的一体化管理。条形码中的ID号是高值耗材的唯一身份代码,即维护了患者的切身利益,又确保了医院感染控制的要求,使高值耗材管理步入医院良性＂动态＂管理体系。     

中药质量追溯体系研究现状

中药质量和安全直接影响着整个中医药行业的发展,通过对我国中药质量控制现状进行分析,发现影响中药质量主要包括中药自身因素和人为因素。为解决此问题,建立中药质量追溯体系是一个行之有效的重要手段,通过对中药信息的记录、查询以及产品的溯源,实现中药材"从生产到消费"全过程的追踪和监管。本文从溯源体系概念性进行阐述以及对追溯技术在食品、农业等方面运用的借鉴,结合我国在溯源体系建设中已取得的进展和创新,探讨中药质量溯源体系研究中的问题,并提出解决方案;最后对该体系的研究现状进行总结和展望。     

自建生化检测系统的量值溯源性和可比性研究

目的探讨实现自建生化检测系统量值溯源性和可比性的方法。方法以新鲜患者血清为临时校准品,在目标检测系统上定值后校准自建检测系统,校准验证有效后,在自建检测系统上对日常校准品进行定值,用新的校准值校准自建检测系统,经校准验证后,进行方法比对,评估自建检测系统与目标系统检测结果的偏倚是否在可接受范围内。结果自建检测系统Ⅰ与目标系统不具可比性的6个项目包括总胆红素(TBil)、直接胆红素(DBil)、γ-谷氨酰基转移酶(GGT)、三酰甘油(TG)、总钙(TCa2 )、无机磷(IP),自建检测系统Ⅱ与目标系统不具可比性的5个项目包括白蛋白(Alb)、TBil、DBil、TG、IP,经校准和校准验证后,与目标系统的偏倚均<1/2CLIA′88允许总误差(TEa),临床可以接受。结论校准和校准验证是实现自建检测系统量值溯源性和可比性的有效途径。