临床级干细胞实验室建末设标准中英文对照.docVIP

临床级干细胞实验室建设标准 Rating Scale Definitions 评分标准 Scale Compliance Rating， 符合状况评分 Execution rating 执行状况评分 1 No system in place 没有任何系统 No data generated 没有产生任何数据 2 System with major deficiencies 系统有重大缺陷 Major deviations 执行中有重大偏差 3 System with minor deficiencies 系统有非重大之缺陷 Minor deviations 执行有非重大偏差 4 System with out significant deficiencies 系统无明显缺陷 Good with out significant deficiencies 执行好，无明显缺陷 5 System is state of the art 系统非常先进 Excellent 执行优秀 System Rating 对系统的评分 Practice Objective 目标 Compliance rating 符合情况评分 Execution rating 执行情况评分 Comments 评注 1 Standard Operating Procedures and Methods 标准操作规程和方法 2 2 SOPs need to be translated. SOP需要翻译 2 Lab Facilities and Environmental Control 实验室设施和环境控制 3 3 Facility is of suitable size and layout, however, it does not allow for proper access/egress. No monitoring system is in place. 设施的大小及布局基本合适，但不能满足恰当的进 / 出要求。没有安装监控系统 3 Equipment Maintenance and Calibration 设备保养及校准 3 2 The equipment is properly maintained and used, but no records are available. 设备保养和使用比较恰当，但无记录 4 Supplies and Reagents Management Control 耗材及试剂管理和控制 3 2 Supplies and reagents are not properly tracked during use. Records are incomplete. 耗材和试剂在使用时缺少恰当的记录。记录不完整 5 Sample Transfer 样品转移 3 3 Current SOP needs to be updated to reflect procedure. 当前的SOP需要更新以反映当前的程序 6 Labeling Controls 标签控制 3 2 Samples are not appropriately labeled. 样品没有恰当地贴标签 7 Storage Requirements 存储控制 NA 无关 NA 无关 8 Receipt and Processing of Tissue 组织样品的接受和处理 3 2 Samples are processed for autologous use, but the cleaning done between patients is inadequate. 样品处理的目的是自体使用，但病人之间的清洁不恰当 9 Quality Control Program 质量控制程序 2 1 No reports available. 没有质量控制报告 10 Personnel 人员 3 2 The lab is appropriately staffs, but no records are available of training or job descriptions. 实验室人员配置合理，但没有培训记录和工作责任描述 11 Records 记录 2 2 Records are incomplete or lacking. 记录不完整或根本没有 12 Personal Protective Equipment 人员防护设备 4 3 The proper P