北京天坛医院单凯博士:全自动化、互联网质控管理是POCT两大发展趋势

2020-12-05 焦艳丽 动脉网

POCT以其便捷、易操作的特点,在危重病、急救患者的快速诊断、动态监测、治疗效果评估等方面得到越来越广泛的认可。但同时POCT也面临着质量管理不规范、不完善的问题亟待解决。

POCT以其便捷、易操作的特点,在危重病、急救患者的快速诊断、动态监测、治疗效果评估等方面得到越来越广泛的认可。但同时POCT也面临着质量管理不规范、不完善的问题亟待解决。

2020年11月13日-14日,由中国医疗器械行业协会现场快速检测(POCT)分会、重庆市江北区人民政府主办的“2020中国POCT年会”在重庆召开。会议以“北斗+5G,筑梦中国 POCT”为口号,以“精准抗疫,全民健康”为主题,论坛内容涵盖现场快速检测应用、纳米酶与 POCT、超声检测、POCT 与基层医疗、POCT与六大中心等话题,设立了主题大会、十三场学术分论坛交流及企业产品展览展示。

14日,在POCT与六大中心分论坛上,首都医科大学附属北京天坛医院急诊科副主任医师单凯以“急诊POCT的质量控制与管理”为题,发表了演讲,动脉网对其精彩观点进行了整编。

单凯:医学博士,首都医科大学附属北京天坛医院急诊科副主任医师;现任中华急诊医学教育学院常务委员、中国医学救援学会急诊分会理事及北京急诊抗感染学会委员等多项社会团体任职;曾主持并参加数项科研课题,在国内外杂志以第一作者身份发表学术论文10余篇,其中SCI收录文章3篇,参编专业书籍5部。

质控是POCT检测的生命线

急症科是一个特殊的科室,儿科、血管等科室以具体学科或是疾病进行命名,急症科则是以时间命名,突出“急”字。因此,对急诊科来说,尽量缩短患者就诊时间,快速、准确出具检验报告是保证患者满意度的关键。

POCT系统完美契合了急诊科的工作需求,是帮助提高急症室效率的重要设备。急诊医学有着多方面的POCT检测需求,包括急性胸痛、急性呼吸困难、急性血糖检测、急诊药物或毒物检测等。

2012年出台了急诊、ICU质量建设标准,明确提出在急诊科和ICU环境中,需要快速获取检验结果。例如,针对一个急性胸痛患者,急诊科需要在3分钟之内获取血气分析结果,10分钟内完成心电图,15分钟内获取cTnI、BNP数值,20分钟内完成病史收集、心电图和POCT相关检测。

但是,目前POCT检测仍旧存在着不少局限性,例如操作者技术水平参差不齐导致检测误差、产品质量控制体系不完善、政策法规和管理尚不明确、检测项目单一、检测量局限等。数据显示,这些局限性导致的假性问题约占检验问题的30%,对急诊科的工作提出了巨大的挑战。

单凯博士认为,在上述提到的众多问题中,质量管理体系不健全是影响POCT检测准确性的重要原因。不准确的检验结果不仅不能够为临床诊断、治疗提供依据,甚至会产生误导。

POCT质量管理体系不健全的因素包括人员(质控观念淡薄、缺乏检测培训、未授权上岗);仪器(仪器多分布广、缺乏维护保养、未做校准);物料(无出入库管理、无质控品);检验报告(无参考区间、格式不规范、无审核);质量(未做比对、未参加EQA、未做IQC);管理(无管理机构、无培训机构)六大方面。

规范POCT质量管理势在必行

POCT 质量管理体系与医疗质量和安全的提升息息相关,质量管理势在必行。

单凯博士总结了POCT质量管理的四大意义:(1)及时发现检验仪器或试剂可能存在的故障或问题,避免错误检验报告;(2)定期监测仪器的系统误差及随机误差,避免严重误差的检验报告;(3)随时掌握仪器的运行状态,有效增强医生和检验人员对已发报告,尤其是异常报告的信任度;(4)检验结果是否准确直接影响对病患的抢救。

国际上已经形成了相对健全的文件体系以指导POCT管理。美国标准化委员会针对POCT制订了CLSI POCT条目文件,从指导如何选择POCT仪器到如何搭建POCT管理体系均有详细要求。在美国由FDA将POCT分为可豁免和不可豁免两类。很多发达国家也从管理与技术两个维度出发制定了相关POCT管理标准,例如澳大利亚RCPA、英国MHRA等均有POCT相关标准。

国内也在不断加强和完善POCT质量管理体系,发布了《手持式现场快速检测(POCT)临床应用与质量管理专家共识》、《即时检测质量和能力的要求》、《医疗机构临床实验室管理方法》、《医疗机构便携式血糖检测仪管理和临床操作规范(试行)》等多个重磅文件。

POCT发展两大趋势:全自动化+互联网质控管理

单凯博士表示,急诊POCT应该尽可能减少操作人员的检测压力和强度,广泛拓展检测项目并实现高通量,打造网络化管理平台实现更专业的信息化质量管理,有效减少人为操作带来的检测误差,保证结果的准确性。

全自动化、互联网质控管理是急诊科POCT两大发展方向。

国外调查显示,19%的POCT操作人员未经培训,25%的POCT操作人员未按照生产商的规定要求操作,32%未按规定要求做质控,6%使用过期的试剂。涉及检测项目多、检测平台多、各厂家定值差异大、半自动仪器导致结果误差大素来是POCT质量管理难点,急需进行标准化、网络化管理。

互联网平台拥有质控管理、多维度权限管理、患者视图、日志管理、内部管理等多功能模块,可全面、个性化满足医院质控管理需求。

首都医科大学附属北京天坛医院在互联网质控管理系统方面做了大量实践,已经依托质量控制管理系统Getein uni-Q实现了多科室互联,全面提升了临床检验的质量管理。

在理想状态下,Getein uni-Q可通过互联网平台式的管理系统,布局整个分级诊疗,最大程度提升各医院相关设备和试剂的标准化质控管理水平。未来,北京天坛医院将陆续实现多医院(区域中心/医联体)互联,以及临检中心-多医院互联。

POCT另一个发展方向是全自动化。自动化可避免人为操作误差,实现自动识别,满足不同批次试剂的质控要求,最大程度提升试剂和仪器性能的标准化管理。

北京天坛医院急诊科已经和信息中心、检验中心,及厂家共同实现了双向LIS流程。北京天坛医院急诊科使用双向LIS流程如下:不用核对样本编号和设置检验项目,样本上架进行检验-仪器自动询问样本检验项目-LIS根据条码号进行自动核收-LIS系统自动回复仪器样本需要检测的项目-检验完成自动获取结果上传。

通过双向LIS一键完成所有检测,极大地减轻了操作者的工作量,大大提升了检测效率和稳定性,有助于POCT质控管理,是医院急诊科的必备之选。

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    2021-07-08 zhs3882
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    2021-10-25 habb
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    2020-12-05 一韦

    急诊和普通门诊,或者是消费型的场景下,POCT最大的区别是什么?急诊要求快速获取结果,临床应用准确是基本要求,质控是通过互联网还是什么物联网,都只是手段,保证准确的基础上,越快越好。消费场景的POCT更多是偏定性,如果是疾病到医院需要进入医疗机构诊断,再定量也 不迟。 #POCT#

    0

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