标本溶血率能否客观定量监测?
有无客观量化评价标准?
如何从源头上避免标本溶血?
这些让检验与临床纠结的问题,
都有了客观解决推荐方法!
中国医师协会检验医师年会召开期间,在5月9日中国医师协会检验医师分会中医检验医学专委会(简称中医检验专委会)会议暨学术交流会上,中医检验专委会发布了《溶血指数质量指标建立与标本管理专家共识(征求意见稿)》(简称本《共识》)。
本《共识》内容有溶血指数质量指标设置与选用、静脉血标本常见溶血缺陷分析改进等,为医疗机构选择应用特异、敏感溶血指数质量指标、应用溶血指数质量指标监控改进标本溶血缺陷提出了专家建议。
中医检验专委会寿好长主任委员对本《共识》的研制与应用做了说明,强调将溶血指数检测新技术用于标本质量指标的精准监管,不是为了秋后算账,而是为了进一步分析根本原因,采取有针对性的改进措施,做好源头治理,避免标本溶血。
本《共识》是在《临床标本溶血检测与检验结果报告专家共识》发表基础上研究制定的。《临床标本溶血检测与检验结果报告专家共识》对标本溶血检测、结合溶血指数评价验收标本及报告检验结果等提出了专家建议,对于规范实验室科学合理判断溶血程度、减少标本拒收、及时发出溶血标本检验报告有指导意义,部分实验室初步应用后显示,可显著减少溶血标本拒收,减轻了患者痛苦,降低了医疗成本、医疗纠纷风险,获得临床好评。
本《共识》的实施应用,将促进标本质量监控管理,从源头控制标本溶血质量缺陷,避免发生标本溶血,有效降低标本溶血率。
附件:
溶血指数质量指标建立
与标本管理专家共识
(征求意见稿)
标本溶血是临床实验室(简称实验室)最常见的误差来源,是标本拒收的主要原因,因标本溶血发出错误结果报告可能造成误诊误治,重新抽血给患者增加痛苦、延长报告周期,复测造成人力、物力、经济损失,实验室有必要开展溶血率质量指标监控标本溶血缺陷[1-3]。
由于定义、数据采集方法不同等原因,文献报告的溶血率结果变异性大,不利于实验室内部纵向监测和外部横向比较、合理评估及采取针对措施预防溶血缺陷[2,4-8]。
为促进实验室充分利用客观、量化、简便、高效的溶血指数质量指标监控标本质量,从源头控制血标本溶血质量缺陷,降低标本溶血率,在《标本溶血检测与检验结果报告专家共识》发表基础上[9],参考国内外相关文献并结合国内实际情况,编写《溶血指数质量指标建立与标本管理专家共识》,
旨在提出建立生化仪检测溶血指数质量指标及用于标本质量管理要求,促进医疗机构应用溶血指数质量指标监控分析血标本溶血率缺陷、采取有效改进措施,进而进一步保证标本质量。
随着技术发展、认识深化,《溶血指数质量指标建立与标本管理专家共识》将适时修订,以适应检验医学发展和临床应用的需要。
1.溶血指数检测方法建立与质量控制
1.1开展仪器法检测标本溶血指数,通过自动化生化仪测定标本血清或血浆血红蛋白特定波长吸光度值,报告血清或血浆中的血红蛋白浓度,常以溶血指数表示,检测结果较目测法准确、快速[6,10]。
1.2 实验室应开展溶血指数检测的性能验证、校准、室内质控、内部比对,参加室间质评计划或进行实验室间比对[11-14]。
2.溶血指数质量指标设置与选用
2.1 建立客观、量化、易实施的溶血指数质量指标,可用于有效监控生化血液标本采集、送检、标本处理等工作部门、岗位个人工作质量[15-17]。
2.2 实验室应动态监控溶血指数溶血率。参考国内外文献[8,15-25],结合国内实验室实际情况,推荐选择仪器法检测溶血指数≥50(相当于血清/血浆血红蛋白≥0.5g/L)、≥25(相当于血清/血浆血红蛋白≥0.25g/L)、≥15(相当于血清/血浆血红蛋白≥0.15g/L)的溶血指数质量指标及限值,见附表。
2.3 实验室应优先选择应用溶血指数≥50标本溶血率质量指标[26]。溶血指数≥25、溶血指数≥15标本溶血率指标更为敏感,可选择用于检验前过程各环节、部门、岗位的标本溶血潜在缺陷的监控[17-22]。
2.4 应准确采集统计数据,纳入全部符合溶血指数血标本,包括让步检验、拒收的溶血标本,排除质控、复测、尿液等不适用标本。
2.5质量指标初建期间,监控反馈周期宜短,比如每月1次,随着监控结果稳定,可适当延长。
2.6 推荐的限值量化标准主要参考相关研究文献及国内实验室实际情况提出,可用于目前监控检验工作质量参考,将来随着工作进展调整,不属于硬性规定。实验室应用前应验证检测方法性能、检验前工作过程的适用性。尚未达到限值要求的实验室,应结合自身实际分析发生标本溶血原因,通过优化服务流程、操作规程,消除质量缺陷,达到要求,并应不断改进,将标本溶血率降至更低。
3.通过监控溶血指数质量指标改进标本质量缺陷
3.1 标本溶血主要发生在标本采集过程,也可发生在转运、实验室离心处理过程[4,17]。实验室应开展溶血指数质量指标监测、参加溶血指数质量指标室间质评、实验室间比对,及时与相关部门沟通、评估,主动分析查找检验前过程各环节存在的溶血缺陷原因,制定实施改进计划[14,27-29]。
3.2静脉血标本溶血常见缺陷类型分析
3.2.1标本采集[30-35]
采血损伤,如反复进针、血肿部位采血;从静脉留置针、输液管、中心静脉导管等血管通路装置采血;注射器采血;未首选肘前正中静脉、头静脉及贵要静脉;使用细针头;消毒剂未干;止血带使用超过1分钟;未及时混匀、剧烈震荡混匀;采血量不足,未达采血管真空度量刻度;真空采血管、分离胶质量差;使用大容量真空采血管等。
3.2.2标本转运[30-31,36]
气动传输过程中剧烈震荡;转运时间长;转运车温度过高、剧烈震荡等。
3.2.3实验室标本处理[30-31,37]
标本保存时间长;标本保存温度过高;未及时离心;离心前血液未完全凝固;离心温度过高、速度过快;再次离心等。
3.2.4体内溶血[38-40]
自身免疫性溶血性,如血型不合输血;遗传、代谢病,如地中海贫血、肝豆状核变性;用药后药物溶血反应,如静脉注射头孢曲松钠致急性溶血反应;重度感染;弥散性血管内凝血;心脏支架、人工心脏心瓣膜、体外膜肺氧合治疗等。体内溶血造成的标本溶血实验室不应拒收,医师应在申请单上标注说明。
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