北京市49家三级医院医学实验室酶学检验结果测量不确定度的评定与分析

目的用"自上而下(top-down)"方法评定北京市49家三级医院临床实验室肌酸激酶(CK)、乳酸脱氢酶(LDH)、γ-谷氨酰基转移酶(GGT)常规检验结果的测量不确定度,鉴别并分析其主要来源。方法应用"top-down"方法,通过酶学参考测量程序赋值的人血清和实验室室内质控数据评估酶学检验结果的测量不确定度。以常规实验室重复测量赋值血清10次数据评估偏移引入的相对测量不确定度分量[ucrel(bias)];以连续3个月实验室室内质控统计数据评定实验室内复现性引入的相对测量不确定度分量[urel(RW)];再通过ucrel(bias)和urel(RW)计算相对合成标准不确定度(ucrel)和相对扩展不确定度(Urel)。结果 49家实验室测量不确定度的评定结果显示:对于CK、LDH、GGT 3个指标,在合成ucrel(bias)的3个分量中,测量平均值与赋值血清定值的相对偏移量值(brel)是ucrel(bias)的主要来源。3个指标ucrel(bias)引入的不确定度均大于urel(RW)引入的不确定度;ucrel(bias)的离散度亦明显大于urel(RW);并依CK、LDH、GGT次序顺序增大。CK、LDH、GGT指标Urel的中位数和四分位数分别为8.72%(6.08%,12.26%)、9.45%(6.66%,16.68%)、9.90%(6.28%,21.29%);若修正偏移,Urel将会有相当程度的改善,中位数和四分位数分别为4.77%(3.84,7.41%)、5.50%(4.06%,7.35%)、4.68%(3.56%,6.31%)。检测系统分组数据显示:依组成分组,其组间平均brel的差异均无统计学意义(P均0.05);据校准品分组,LDH、GGT指标组间平均brel的差异有统计学意义(P0.05)。结论 brel是实验室主要不确定度来源;使用某厂家校准品或不使用校准品的分析系统是产生偏移的主要因素。统一评估测量不确定度是改善酶学检验结果实验室间可比性的方式。     

药品检验用仪器设备性能验证指导原则和技术标准的探讨

目的 为了规范我国药品检验用仪器设备性能验证工作,加快国内药品检验机构在仪器设备质量控制和管理方面与国际先进实验室接轨,符合世界卫生组织药品预认证的相关要求.方法 概述了仪器设备性能验证的基本概念和内容,验证工作的必要性,国内外性能验证的基本情况以及差距,探讨了国内药品检验机构开展性能验证的思路和方法,借鉴了北京市药品检验所开展高效液相色谱仪性能验证的经验.结果 引进国际先进的4Q模型理论可以帮助国内药品检验机构有效提升仪器设备质量控制和管理水平,开展仪器设备性能验证工作,符合国内外监管机构和权威组织的法规和认证要求.结论 尽快制定国内药品检验领域仪器设备性能验证指导原则和技术标准是促进我国药品检验机构和制药企业参加国际合作和竞争的重要技术保障.     

Standardization in laboratory medicine: Adoption of common reference intervals to the Croatian population

Considering the fact that the results of laboratory tests provide useful information about the state of health of patients, determination of reference value is considered an intrinsic part in the development of laboratory medicine. There are still huge differences in the analytical methods used as well as in the associated reference intervals which could consequently significantly affect the proper assessment of patient health. In a constant effort to increase the quality of patients’ care, there are numerous international initiatives for standardization and/or harmonization of laboratory diagnostics in order to achieve maximum comparability of laboratory test results and improve patient safety. Through the standardization and harmonization processes of analytical methods the ability to create unique reference intervals is achieved. Such reference intervals could be applied globally in all laboratories using methods traceable to the same reference measuring system and analysing the biological samples from the populations with similar socio-demographic and ethnic characteristics. In this review we outlined the results of the harmonization processes in Croatia in the field of population based reference intervals for clinically relevant blood and serum constituents which are in accordance with ongoing activity for worldwide standardization and harmonization based on traceability in laboratory medicine.     

供应室管理系统在消毒供应管理工作中的应用与体会

以医院信息系统(HIS)为支撑平台,依托无线网络、移动终端、条形码识别等先进技术,将供应室管理系统应用于消毒供应管理工作中,通过信息化管理及质量追溯系统,强化流程控制,提高工作效率,建立完善的数据电子档案,实现消毒质量监控与实时追踪,提高了供应室的护理管理水平,使护理技术逐步走向科技化和产业化。     

Beckm an A U 680生化分析仪性能评价及溯源

目的对 Beckman AU680生化分析仪主要性能进行评价,判断其是否能够满足本实验室需求.方法按照实验室管理办法及国家实验室认可的要求,分别采用美国临床和实验室标准协会(CLSI)的 EP5‐A2、EP6‐A 和 EP9‐A2文件评价方法对碱性磷酸酶(ALP)、天门冬氨酸氨基转移酶(AST )、血肌酐(Cr)、血清总胆红素(TBil)的精密度、准确度和线性、携带污染率进行分析.对钾(K +)、钠(Na +)、氯(Cl -)与 Olympus AU2700进行对比分析.结果Beckman AU680生化分析仪 ALP 、AST 、TBil 、Cr 、K +、Na +、Cl -批内精密度变异系数(CV)均小于或等于1/4CLIA′88,总精密度 CV 均小于或等于1/3CLIA′88;在准确度实验中,ALP 、AST 、TBil 、Cr 测定相应质控品,与质控品给定范围比较均在测定范围内;K +、Na +、Cl -与 Olympus AU2700的对比实验中,Beckman AU680检测系统呈明显相关,相关系数 r2>0.92,各检测项目在其医学决定水平上的相对偏倚均小于或等于1/2CLIA′88;Beckman AU680 ALP 、AST 、TBil 、Cr 线性良好(r2>0.95).结论Beckman AU680生化分析仪性能满足本实验室需求.     

临床试验静脉用药调配中心的应用可行性研究

目的:研究临床试验静脉用药调配中心(GCP-PIVAS)的应用可行性。方法:通过举例、回顾性统计分析的方法进行研究。结果:GCP-PIVAS可实现临床试验注射类药品入库、配置、配送记录的电子化溯源,减少配置差错、药物污染,增强职业防护,降低成本,保障药物临床试验数据完整性、规范性及设盲试验的严谨性。结论:GCP-PIVAS保障临床试验注射类药品使用安全,提高机构抗风险能力,对全面提升医院的临床试验管理水平将起到重要作用。     

Cluster analysis of toxins profile pattern as a tool for tracing shellfish contaminated with PSP-toxins

Paralytic shellfish poisoning (PSP) is one of the most lethal biotoxin-induced diseases worldwide, which may pose serious public health threat and potential devastating economic damage on fisheries industry in the affected region(s). To prevent the importation of PSP contaminated shellfish to a community, detailed documentation on the supply chain and routine surveillance systems are, in principle, crucial measures to protect people from this intoxication. However, difficulties have always been encountered on the traceability of the source/origin of contaminated shellfish.In the present study, we reported the potential application of PSP-toxins profiles with similarity analysis that can be used to identify epidemiological linkage between shellfish samples collected from markets and patients during a PSP outbreak. PSP-toxins were identified and quantified by ion-pair chromatographic separation followed by post-column oxidation to fluorescent imino purine derivatives. Samples from a PSP incident and other surveillance samples collected in our past 7-year record were also compared for their similarity in PSP-toxins profiles patterns. Molar distributions (nmol%) of 10 PSP-toxins were analyzed by Unweighted Pair Group Method with Arithmetric averages (UPGMA). Three prominent clusters emerged with similarity levels reaching over 80% for each, suggesting that each group of samples probably originated from a same source/batch. The PSP-toxins profiles and toxicities determined from surveillance samples could provide premonitory clues on the occurrences of PSP incident and outbreak with corresponding toxin profiles in the later time. Due to species-specific characteristics of PSP-toxins composition and profile in shellfish under varieties of environmental and physiological conditions, PSP-toxins profile can be a specific and useful biochemical indicator for tracing PSP contaminated shellfish provided that spatio-temporal occurrence patterns of toxins profiles are available in a databank for inter-laboratory comparison and standardized methodologies such as consentaneous toxins extraction and identification criteria are used for analysis and comparison.     

基于UDI实现医疗器械供应链全程追溯管理

目的 基于医疗器械唯一标识(Unique Device Identification,UDI)及信息化技术对医疗器械产品供应链上的全链条数据通查通识,以加强医疗器械全生命周期管理,实现医疗器械供应链的全程追溯,保证民众用械安全.方法 试点选取覆盖高值耗材、低值耗材、体外诊断试剂、骨科耗材的产品线,应用医疗器械全程追溯信...     

丙氨酸氨基转移酶检测系统溯源性研究

目的建立深圳市龙华人民医院院检验科丙氨酸氨基转移酶(ALT)检测系统的溯源性,提高最终检测结果的准确性。方法依据《GB/T 21415-2008/ISO 17511:2003》中的国际标准溯源链式图自建该医院检验科溯源流程图;购买参考物质IRMM ERM AD 454,通过测定临床新鲜血清标本进行临床比对确保参考物质具有互通性,同时采用SPSS17.0进行统计学分析,以97%的预测区间和检测项目1/4CL IA’88总允许误差为标准,达到量值传递验证要求,进一步确定不确定度,完成量值溯源工作。结果通过该医院自建的溯源流程实验,证明丙氨酸氨基转移酶试剂盒的产品校准品与IRMM ERM AD 454之间存在互通性,按照不确定度计算公式得到产品校准品的不确定度,赋值表示为135±5U/L。结论该医院检验科自建溯源流程成功对产品校准品进行了赋值修正,提高了试剂检测结果的准确性。