2021年1月23日发(作者：粘鼠板)

临床级干细胞实验室建设标准

Rating Scale Definitions
评分标准

Scale
Compliance Rating
，

Execution rating
执行状况评分

符合状况评分

1
No system in place
No data generated
没有任何系统

没有产生任何数据

2
System with major deficiencies
Major deviations
系统有重大缺陷

执行中有重大偏差

3
System with minor deficiencies
Minor deviations
系统有非重大之缺陷

执行有非重大偏差

4
System with out significant deficiencies
Good with out significant deficiencies
系统无明显缺陷

执行好，无明显缺陷

5
System is state of the art
Excellent
系统非常先进

执行优秀


System Rating
对系统的评分

Practice
Compliance
Execution
Comments
Objective
目标

rating
rating
评注

符合情况评
执行情况
分

评分

1
Standard Operating Procedures and
2
2
SOPs need to be translated.
Methods
SOP
需要翻译

标准操作规程和方法

2
Lab Facilities and Environmental
3
3
Facility is of suitable size and layout, however,
Control
it does not allow for proper access/egress. No
monitoring system is in place.
实验室设施和环境控制

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
3
2
The equipment is properly maintained and
Calibration
used, but no records are available.
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4
设备保养及校准

Supplies and Reagents Management
Control
耗材及试剂管理和控制

Sample Transfer
样品转移

Labeling Controls
标签控制

Storage Requirements
存储控制

Receipt and Processing of Tissue
组织样品的接受和处理

3
2
5
3
3
6
7
8
3
NA
无关

3
2
NA
无关

2
设备保养和使用比较恰当，但无记录

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

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

Samples are not appropriately labeled.
样品没有恰当地贴标签


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

No reports available.
没有质量控制报告

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

Records are incomplete or lacking.
记录不完整或根本没有

The proper PPE is available, but is not utilized
to reduce the risk of contamination.
人员防护设备存在，但没有为了减低污染风
险而使用

9
10
Quality Control Program
质量控制程序

Personnel
人员

2
3
1
2
11
12
Records
记录

Personal Protective Equipment
人员防护设备

2
4
2
3

Assessment Objectives
评估目标

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1.

Standard Operating Procedures and Methods
标准化操作规程（
SOP
）和方法

a.

SOP in writing and available to approved personnel.
SOP
正确编写，并且对工作人员来说是切实可用的。

b.

Personnel properly performing SOP as stated.
工作人员能够按照
SOP
正确操作。

c.

Are current SOPs being implemented?
当前使用的
SOP
是有效的？

2.

Lab Facilities and Environmental Control
实验室设施及环境控制

a.

Facility of suitable size and properly maintained.
实验室设备的匹配性及恰当的维护。

b.

Facility divided into separate or defined areas for each operation.
仪器设备分区放置及每项操作有专门的区域。

c.

Does the facility maintain a proper access/egress?
实验室的出入口安排恰当。

d.

Proper environmental control for equipment and facilities.
实验室环境控制安排合理性。

e.

Facility restricted to authorized personnel.
出入实验室人员的权限。

3.

Equipment Maintenance and Calibration
设备维护和校正

a.

Equipment properly maintained.
仪器设备的正确维护。

b.

Equipment of suitable design and use.
仪器设备合理匹配和使用。

c.

Proper SOP established for the cleaning, maintenance, testing, calibration, use, and standardization of the equipment
established.
建立正确的清洁、维护、测试、校准、使用设备的
SOP
。

4.

Supplies and Reagents Management Control
耗材和试剂管理控制

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