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****医院临床检验中心临床基因扩增实验室管理程序标准操作程序（SOP）起草人：批准人：生效日期：年月日目录临床基因扩增实验室的设置····································································4临床基因扩增实验室内部管理规章·························································12临床基因扩增实验室人员管理、配置及培训··············································16临床基因扩增实验室的设施和环境·························································19临床基因扩增实验室清洁制度规章·························································20临床基因扩增实验室仪器设备管理规章···················································22Roche480II实时荧光定量PCR仪操作规程、维护方法、校准（SOP-1）未修改·27Finnpipette可调式移液器的使用与维护标准操作(SOP-2)······························36Finnpipette可调式移液器校准标准管理程序(SOP-3)····································40温度计及湿温度计的校正标准管理程序(SOP-4)··········································41离心机使用与维护标准操作程序(SOP-5)··················································42超净工作台使用与维护标准操作程序(SOP-6)·············································46恒温水浴箱使用、维护与校正（SOP-7）·················································47旋涡振荡器使用与维护标准操作程序（SOP-8）·········································50冰箱的使用与维护标准操作程序（SOP-9）··············································51可移动紫外灯标准操作程序（SOP-10）···················································53仪器故障时标记、放置标准操作程序（SOP-11）·······································54仪器设备发生故障时的应急处理程序（SOP-12）·······································55临床标本的收集管理标准操作程序（SOP-13）··········································58检验标本的验收和保存标准操作程序（SOP-14）·······································59样本编号的标准操作程序(SOP-15)··························································64PCR标本管理标准操作程序（SOP-16）···················································66标本前处理标准操作程序（SOP-17）······················································68核酸扩增及产物分析检测标准操作程序（SOP-18）····································69乙型肝炎病毒基因扩增检测标准操作程序（SOP-19）·································71基因扩增检测实验结果分析标准操作程序(SOP-20)·····································76实验结果有效性判断标准操作程序（SOP-21）··········································79室内质量控制标准操作程序(SOP-22)·······················································80实验室试剂耗材购买、验收和贮存的标准操作程序（SOP-23）·····················86试剂质检标准操作程序（SOP-24）·························································92实验室耗材质检标准操作程序（SOP-25）················································95手套使用及左右手分开的原则（SOP-26）················································98实验室化学试剂贮存使用、废弃物处理及生物防护（SOP-27）·····················99抱怨的处理程序（SOP-28）·································································102实验室记录管理规章标准操作程序（SOP-29）·········································106检验报告单管理标准操作程序（SOP-30）···············································109实验室台面摆放顺序程序（SOP-31）·····················································113实验室常用溶液配置标准操作程序（SOP-32）·········································114****医院临床检验中心SOP文件实验室操作规程文件编号：版本：2013第三版生效日期：2013/01/01临床基因扩增实验室设置标准操作程序第4页共114页****医院临床基因扩增实验室-4-临床基因扩增实验室的设置1目的：依照实验室设置规范实现核酸扩增荧光检测实验室配置合理，以保证实验工作健康有序及实验结果的可靠性2范围：临床基因扩增实验室及相关工作人员，并明确各项规章制度3操作人：****4实验室设置规章：4.1依据：本实验室按《临床基因扩增检验实验室管理暂行办法》（卫医发[2002]10号）中临床基因扩增检验实验室基本设置标准结合本实验室的条件进行设置，并严格按照《临床基因扩增检验实验室工作规范》（卫检字2002第8号）的要求开展临床基因扩增工作(拟开展基因扩增检验项目见附表1)4.2实验室设置:4.2.1实验室主要由试剂储存和准备区（PCR-Ⅰ）、标本制备区（PCR-Ⅱ）、PCR扩增及产物分析区(PCR-Ⅲ）三个工作室组成。这三区各自独立，每个区设有缓冲间。其布局见实验室平面图（见附图1）。4.2.2设立各区的门牌，分别是：“试剂储存和准备区（PCR-Ⅰ）”、“标本制备区（PCR-Ⅱ）”、“PCR扩增及产物分析区(PCR-Ⅲ）”，并在各区门上贴有“非本室工作人员不得进入”标记。4.2.3建立实验室内务管理，并放在进入实验室的明显位置（如置于缓冲区的墙上；内务管理应有进入实验的工作流程、进入实验室的要求、实验前的准备及清洁等）。4.2.4三个工作区各配备专用的设备、仪器、辅助设施、耗材、清洁用品、办公用品、专用工作服，并有明显的区分标识：试剂准备区—蓝色，标本制备区—紫色，PCR扩增及产物分析区—黑色。各区的实验物品不得混用（实验室主要设备一览表见表3）。4.2.5进入各区的工作流程为：试剂储存和准备区→标本制备区→PCR扩增及产物分析区。****医院临床检验中心SOP文件实验室操作规程文件编号：版本：2013第三版生效日期：2013/01/01临床基因扩增实验室设置标准操作程序第5页共114页****医院临床基因扩增实验室-5-4.2.6进入实验室必须更换有本室标识的工作服及清洁鞋套，工作人员离开某一工作区时，该区物品不得带出本区（包括工作服等）。4.3各区实验设备及用品配置：4.3.1试剂储存和准备区：冰箱（2～8℃和-15℃）、可调式移液器（覆盖0.5～1000ul）、紫外消毒车、固定紫外线灯，混匀器，专用工作服，一次性用品（手套、带滤心的吸头、鞋套、吸水纸、耐高压处理的离心管），专用实验记录本及记号笔等。4.3.2标本制备区：冰箱（2～8℃和-15℃）、台式高速离心机、水浴锅、净化工作台、混匀器、可调式移液器（覆盖1～1000ul）、紫外消毒车、固定紫外线灯，专用工作服，一次性用品（手套、带滤心的吸头、鞋套、吸水纸、耐高压处理的离心管），专用实验记录本及记号笔等。4.3.3PCR扩增及产物分析区：Line-Gene全自动荧光定量PCR核酸扩增仪、紫外消毒车、固定紫外线灯，专用工作服，一次性用品（手套、鞋套、吸水纸等），专用实验记录本及记号笔等。4.4实验室人员设置：实验室人员配置：我院PCR实验室配备有3名工作人员，其中1人具检验师职称，2人具主管检验师职称。已全部经过安徽省临床检验中心培训，并取得培训合格证（实验室工作人员一览表见表2）。起草人批准人生效日期年月日****医院临床检验中心SOP文件实验室操作规程文件编号：版本：2013第三版生效日期：2013/01/01临床基因扩增实验室设置标准操作程序第6页共114页****医院临床基因扩增实验室-6-附表1拟开展临床基因扩增检验项目一览表项目方法备注HBVDNAPCR荧光实时扩增Line-Gene扩增仪****医院临床检验中心SOP文件实验室操作规程文件编号：版本：2013第三版生效日期：2013/01/01临床基因扩增实验室设置标准操作程序第7页共114页****医院临床基因扩增实验室-7-表2临床基因扩增检验实验室工作人员一览表序号姓名性别年龄学历职务职称所学专业毕业时间从事本专业时间培训合格证号备注1×××√∥中专∝主管检验82．7422002000**2×××√∥中专∞主管检验81．7442003000**3×××√∥中专∫检验师检验95．7312003000******医院临床检验中心SOP文件实验室操作规程文件编号：版本：2013第三版生效日期：2013/01/01临床基因扩增实验室设置标准操作程序第8页共114页****医院临床基因扩增实验室-8-表3临床基因扩增检验实验室仪器设备一览表序号仪器设备名称生产厂家仪器型号仪器序号接收日期接收状态启用日期放置地点接受人签字备注1紫外线消毒车江阴市光电仪器有限公司ZXCⅠ类B型2003-4-18全新2002-5-9试剂准备区2美菱电冰箱××美菱股份有限公司BCD-109624172003-4-19全新2003-4-19试剂准备区3可调式移液器上海雷勃分析仪器有限公司4500120Y557772003-4-19全新2003-5-9试剂准备区4可调式移液器上海雷勃分析仪器有限公司4500020Y500412003-4-19全新2003-5-9试剂准备区5可调式移液器上海雷勃分析仪器有限公司4500100Y458492003-4-19全新2003-5-9试剂准备区6可调式移液器上海雷勃分析仪器有限公司4500090Y567342003-4-19全新2003-5-9试剂准备区7光学读数分析天平湘仪天平仪器厂TG3282003-5-8调拨200