加强临床生化分析前质控 提高检验质量

分析前质量控制是检验结果准确性的重要前提和保证,影响生化分析前质控的因素很多,从临床医生的项目选择到患者的准备、标本采集、送检、标本的预处理等,其中任何一个环节出差都可能影响到检验结果的准确性。检验人员要不断提高自身的综合素质,加强与临床的联系和沟通,不断完善临床生化分析前质量管理体系,强化生化分析前质控每一个环节的管理,努力提高检验质量。     

自制正常值质控血浆应用于凝血项目检查的探讨

许多疾病会引起机体止凝血功能紊乱,故凝血检查广泛应用于临床,尤其在手术前、出凝血性疾病等的诊疗,凝血检查成了必不可少的实验项目.凝血项目检测过程受仪器状态、试剂稳定性及环境温度等因素影响,所以室内质控是日常工作的重要内容之一.     

自制正常值质控血浆应用于凝血项目检查的探讨

许多疾病会引起机体止凝血功能紊乱．故凝血检查广泛应用于临床。尤其在手术前、出凝血性疾病等的诊疗,凝血检查成了必不可少的实验项目。凝血项目检测过程受仪器状态、试剂稳定性及环境温度等因素影响,所以室内质控是日常工作的重要内容之一．     

临床科室对检验质量的影响分析

实验室质量控制是提高检验医学水平,保证检验结果准确性的重要手段,包括分析前、中、后质量控制三个方面。分析中质控主要是检验科的室内质控和室间质评,分析前质控涉及到患者检验前的准备、标本的采集、检测时间的选择及标本保存、运送等,分析后质控涉及到结果解释、与临床表现及其它检查相符性等。临床科室医护人员与分析前和分析后的质量控制关系密切,其操作处理直接影响检验质量。     

凝血试验的室内质量控制

质量控制是提高检验医学水平,保证检验结果准确性的重要手段,包括分析前、分析中和分析后质量控制三个方面,而凝血四项（PT、APTT、TT、Fg）是检测人体血液是否有凝血障碍的几项重要指标。因为检测的是具有酶活性的凝血因子,这些活性的凝血因子影响因素较多,     

凝血试验的室内质量控制

质量控制是提高检验医学水平,保证检验结果准确性的重要手段,包括分析前、分析中和分析后质量控制三个方面,而凝血四项(PT、APTT、TT、Fg)是检测人体血液是否有凝血障碍的几项重要指标。因为检测的是具有酶活性的凝血因子,这些活性的凝血因子影响因素较多,控制不好检测结果将失去参     

两种患者数据均值法用于凝血功能试验室内质控的比较

使用标准质控血浆进行凝血功能试验室内质量控制存在着质控血浆价格昂贵、不稳定、控制物不同于患者标本特征等缺陷，且只能对分析中仪器及试剂的状态进行质控，而对分析前的因素特别是样本因素则不能有效质控。凝血功能试验恰恰更易受到分析前因素的影响。患者数据均值可对分析前及分析中进行质量控制从而弥补了质控血浆对分析前质量控制的不足如样本本身质量的影响。本文对两种患者数据均值法用于凝血功能试验室内质控进行了比较。     

实验室管理与质量控制

应用6σ理论评价临床实验室各阶段性能及设计质控方案,浅谈医学检验分析前质量保证,组合生化检测系统实验结果偏倚评估,分析前质控在止凝血检查中的重要性探讨。     

基层医疗单位如何做好血凝仪的室内质量控制

止凝血检验是临床重要的检测项目之一,但由于凝血检测本身在原理上的特殊,检查过程中的许多环节和因素．都会对检测结果产生不同程度的影响．甚至会造成检验结果与临床不符．我院在做好室内质量控制的基础上,参加省临床检验中心组织的室问质量控制,并取得了优良的成绩．同时感到作为基层医疗单位．血凝标本量较少,试剂每日使用量少．损耗较大,做好室内质控的管理成本较高．并有一定难度,这也是许多兄弟单位会遇到的问题。     

止凝血功能检查的影响因素分析

止凝血检查对于临床各科的疾病诊断具有重大的意义.除了对出血性疾病的筛查与诊断外,还用于对各种血栓性疾病及血栓前状态的检查和预测,弥散性血管内凝血出血疾病的实验诊断以及对各种抗凝治疗患者的用药指导和预后评估等.因此,为保证检测结果的准确,现将影响因素总结如下.     

The truth about quality: medical usefulness and analytical reliability of laboratory tests

BACKGROUND: In this age of evidence-based medicine, nothing is more important than the quality of laboratory tests. It is commonly thought that laboratory tests provide two-thirds to three-fourths of the information used for making medical decisions. If so, test results had better tell the truth about what is happening with our patients. METHODS: The age-old "truth standard" for the quality of evidence describes three dimensions that are important-a test should tell the truth, the whole truth, and nothing but the truth. This three-dimensional model can be used to characterize the clinical and analytical reliability of laboratory tests and guide the translation of outcome criteria, or quality goals, into practical specifications for method performance. RESULTS: Clinical reliability, or medical usefulness, should assess the correctness of patient classifications based on stated test interpretation guidelines, taking into account the precision and accuracy of the laboratory method, and allowing for the known within-subject biologic variation and the QC needed to detect method instability. Analytical reliability should assess the correctness of a test result based on a stated error limit, taking into account the precision and accuracy of the method and allowing for the QC necessary to detect method instability. These assessments challenge the reliability of current tests for cholesterol, glucose, and glycated hemoglobin in the implementation of U.S. national clinical guidelines. CONCLUSIONS: Evidence-based medicine must employ scientific methodology for translating test interpretation guidelines into practical, bench-level, operating specifications for the imprecision and inaccuracy allowable for a method and the QC necessary to detect method instability.     

腹腔镜卵巢囊肿剔除术中不同止血方式对于卵巢功能的影响

目的探讨腹腔镜卵巢囊肿剔除术中不同止血方式对于卵巢功能的影响。方法本院行腹腔镜卵巢囊肿剔除术的单侧卵巢囊肿患者92例,随机分为3组:单极电凝组31例,双极电凝组30例,镜下缝合止血组31例。比较3组患者术前、术后1个月、术后3个月的月经变化、激素水平、手术时间、出血量、卵巢动脉血流参数、窦卵泡数及术后排卵等指标。结果镜下缝合止血组和双极电凝组的术后性激素水平恢复、排卵情况月经情况显著优于单极电凝组,镜下缝合止血组的术后的围绝经期综合征发生率显著低于电凝组,镜下缝合止血组术后的收缩期峰值流速(PSV)、窦状卵泡数目(AFC)与术前相比差异显著。结论镜下缝合止血方式可以保护卵巢储备功能,提高患者的卵巢功能和术后的生活质量,不良反应少,值得临床推广应用。     

产后大出血：凝血功能调节

产后大出血是世界范围内的一种常见产科急症，是孕产妇死亡的主要原因之一。针对产后大出血导致的凝血功能紊乱进行调节，是其治疗的一个重要环节。尽管近年来有关产后大出血危险因素、病理生理过程及治疗已经取得了一些进展，但仍需要从早期实验室凝血功能监测评估、输注血液制品管理、止血药物、抗纤维蛋白溶解剂应用等方面进行系列优化，以期更好地改善患者预后。     

2005～2009年度血凝项目质控情况总结及分析

目的通过总结、分析血凝项目参加全球项目质控情况,指导和改进室内质控工作及日常工作,从而提高患者检测结果的准确性。方法法国Stago公司每年分2次发放冻干质控物,每次两种批号,每种批号各3瓶质控物,测定时用蒸馏水复溶两种批号各1瓶质控物,与患者标本一同测定,重复3d。结果 2006年批号为STA-QCE 2006-3和2006-4的质控物,有部分结果不可接受;其余年度所有结果都在2个标准差范围内。结论对STA-QCE 2006-3和2006-4失败项目进行分析,测定期间室内质控较满意,患者日常结果均值无明显波动,说明可能由于偶然误差导致室间质控结果不满意。在仪器、试剂、操作等方面做改进后,后续室间质控均取得满意成果。     

Comparative study of various rapid methods of determining fibrinogen transformation products in the diagnosis of intravascular coagulation and fibrinolysis

Rapid methods for determination of fibrin-monomer complexes and fibrinogen/fibrin degradation products were studied and compared in 76 patients with different abnormalities in the hemostatic system (acute thromboses, thromboembolism of the pulmonary artery, disseminated intravascular coagulation, immune thrombovasculitis, etc). The control group consisted of 36 healthy donors. The fibrin-monomer complexes were determined by the paracoagulation tests, the ethanol test (ET) and protamin sulfate tests (PST), whereas fibrinogen/fibrin degradation products (FDP) by the staphylococcus adhesion test (SAT) in which use was made of the Newman D2S strain variety obtained by the authors. It is inferred that the ET, PST and SAT are the most suitable for use in clinical medicine, since they are accessible, simple and quick in performance. However, these tests cannot be regarded as similar or interchangeable, since they are used for studying different products of the coagulation and fibrinolytic transformation of fibrinogen.     

风险质量控制方案在甲状腺功能检测项目的应用

目的　设计风险质量控制方案应用于实验室甲状腺功能项目测定的质量控制（Quality Control, QC）中,并与传统QC方法比较。方法　首先评估实验室甲状腺功能五项的西格玛值(σ)，基于风险质量控制策略设计QC方案。方案中:促甲状腺激素(TSH)和游离三碘甲状原氨酸（FT3）的质控规则采用13s, N2；游离甲状腺素(FT4)采用13s/22s/R4s,N2；三碘甲状原氨酸（T3）采用13s/22s/R4s/41s,N4；甲状腺素(T4) 采用13s/22s/R4s/41s/6x, N6。QC事件频率为每40份样本测定一次质控材料。传统质量控制规则采用13s/22s/R4s/41s/10x,N2作为对照。运行两种质量控制方案一个月并进行比较。结果　通过比较发现，σ值较高的TSH，FT3，FT4项目在质控监测过程中性能稳定，风险质量控制和传统质量控制均无失控点。而σ值较低的T3，T4项目在质控监测中稳定性略差，传统质量控制中虽未出现失控点，但风险质量控制过程中就发现失控点，且σ值越低的项目失控点就越多。结论　通过传统质量控制和风险质量控制的应用比较，风险质量控制更能有效的监测分析过程的稳定性。     

Selection of medically useful quality-control procedures for individual tests done in a multitest analytical system

Quality-control (QC) procedures (i.e., decision rules used, numbers of control measurements collected per run) have been selected for individual tests of a multitest analyzer, to see that clinical or "medical usefulness" requirements for quality are met. The approach for designing appropriate QC procedures includes the following steps: (a) defining requirements for quality in the form of the "total allowable analytical error" for each test, (b) determining the imprecision of each measurement procedure, (c) calculating the medically important systematic and random errors for each test, and (d) assessing the probabilities for error detection and false rejection for candidate control procedures. In applying this approach to the Hitachi 737 analyzer, a design objective of 90% (or greater) detection of systematic errors was met for most tests (sodium, potassium, glucose, urea nitrogen, creatinine, phosphorus, uric acid, cholesterol, total protein, total bilirubin, gamma-glutamyltransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase) by use of 3.5s control limits with two control measurements per run (N). For the remaining tests (albumin, chloride, total CO2, calcium), requirements for QC procedures were more stringent, and 2.5s limits (with N = 2) were selected.     

A critical appraisal of point‐of‐care coagulation testing in critically ill patients

Derangement of the coagulation system is a common phenomenon in critically ill patients, who may present with severe bleeding and/or conditions associated with a prothrombotic state. Monitoring of this coagulopathy can be performed with conventional coagulation assays; however, point‐of‐care tests have become increasingly attractive, because not only do they yield a more rapid result than clinical laboratory testing, but they may also provide a more complete picture of the condition of the hemostatic system. There are many potential areas of study and applications of point‐of‐care hemostatic testing in critical care, including patients who present with massive blood loss, patients with a hypercoagulable state (such as in disseminated intravascular coagulation), and monitoring of antiplatelet treatment for acute arterial thrombosis, mostly acute coronary syndromes. However, the limitations of near‐patient hemostatic testing has not been fully appreciated, and are discussed here. The currently available evidence indicates that point‐of‐care tests may be applied to guide appropriate blood product transfusion and the use of hemostatic agents to correct the hemostatic defect or to ameliorate antithrombotic treatment. Disappointingly, however, only in cardiac surgery is there adequate evidence to show that application of near‐patient thromboelastography leads to an improvement in clinically relevant outcomes, such as reductions in bleeding‐related morbidity and mortality, and cost‐effectiveness. More research is required to validate the utility and cost‐effectiveness of near‐patient hemostatic testing in other areas, especially in traumatic bleeding and postpartum hemorrhage.     

经内镜钛夹治疗急性上消化道出血的临床效果

目的探讨经内镜钛夹治疗急性上消化道出血(AUGH)的临床效果。方法选择2018年4月至2019年7月于我院就诊的92例AUGH患者,根据治疗方式的不同将患者分为试验组(n=46,内镜下钛夹止血)与对照组(n=46,内镜下药物注射止血)。比较两组的止血效果、血清炎症因子、应激指标、出血症状评分、Blatchford评分、凝血功能指标及恢复效果。结果试验组的止血总有效率高于对照组(P<0.05)。治疗后,两组的血清CRP、IL-6、TNF-α、Cor、NE水平均降低,且试验组低于对照组(P<0.05)。治疗后,两组的出血症状评分、Blatchford评分均降低,且试验组低于对照组(P<0.05)。治疗后,两组的PT、APTT均缩短,FIB水平均升高,D-D水平均降低,且试验组优于对照组(P<0.05)。试验组的呕血消失时间、OB转阴时间、引流变清时间、肠蠕动恢复时间及住院时间均短于对照组(P<0.05)。结论经内镜钛夹治疗AUGH的止血效果显著,可降低血清炎症因子、应激指标,改善患者的凝血功能,促进临床症状改善。     

Clinical laboratory quality control: a costly process now out of control

We studied laboratory internal quality control (QC) processes using the College of American Pathologists Q-Probes program. Over 500 institutions participated, providing practices based on approximately 710 000 cholesterol, 880 000 calcium, 400 000 digoxin, and 1 180 000 hemoglobin QC results. The costs of QC included participant median control sample rates comprising 9.1, 9.4, 37.0, and 6.8% for the four analytes respectively, repeat patient test rates of 0.36% for hemoglobin to 0.65% for digoxin, and median delays in reporting results when QC exceptions occurred of 15.8 min for calcium to 24.7 min for hemoglobin. Quality control practices were complex and highly variable among participants and frequently differed from internal laboratory protocols and from long-established quality guidelines. We conclude that QC is costly, and laboratorians frequently do not follow established QC practices, in part because they are complex. To improve compliance, we believe QC practices must be simplified.