临床级干细胞实验室建设标准（中英文对照）

Rating Scale Definitions

评分标准

System Rating

对系统的评分

Assessment Objectives

评估目标

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

a.Are reagents and supplies properly labeled with identity, concentration, storage requirements and expiration dates?

试剂和耗材是否正确的标记？包括名称、浓度、储存条件和有效期。

b.Are supplies and reagents being properly stored?

试剂和耗材的保存是否恰当？

c.Are supplies and reagent being properly distributed and tracked during use?

耗材和试剂使用时是否正确的编号和记录？

d.Are deteriorated or outdated reagents being used?

是否使用过期的试剂？

5.Sample Transfer

样品的传送

a.Are samples appropriately labeled for autologous processing?

在治疗过程中，样品是否正确的标记？

b.Samples appropriately transfer in transport cooler/device?

样品传送过的方法是否恰当？保温箱等设施的使用？

6.Labeling Controls

标签控制

a.Autologous samples properly labeled with:

病人的样品需要标记下面几项：

i.Patient name or code number.

病人姓名或代号。

ii.Date of birth.

出生日期。

iii.Contents and collection date or time.

内含物和收集时间。

iv.Volume of samples.

样品的体积。

v.Quality of sample.

样品的质量。

b.Reagents used in processing appropriately labeled?

治疗过程中使用的试剂是否正确标记？

7.Storage Requirements

储存要求

a.Cells properly handled for cryopreservation.

细胞按照正确的方法低温储存。

8.Receipt and Processing of Tissue

组织样品的接受和处理

a.Are samples maintained for autologous processing?

样品在治疗过程中是否正确处理？

9.Quality Control Program

质量控制程序

a.No deviations from approved protocols or SOPs are made without proper authorization and documentation.

诊断记录中没有出现变异情况或在没有经过审定和证实的情况下制定SOPs。

b.Procedure and reports available upon request.

操作过程和报告的有效性。

10.Personnel

人员

a.Personnel should have the necessary education, experience, and training to ensure competent performance of assigned functions.

工作人员应该有适当的教育背景、经验和培训，保证能够完成相应的工作。

b.Personnel should perform only those activities for which they are qualified and authorized.

工作人员只能去完成他们能够胜任的工作。

c.Sufficient number of personnel to perform the procedures in a timely manner.

实验室工作人员的数量能够保证实验室的工作及时有效地完成。

d.Personnel take necessary sanitation and health precautions to avoid contamination of tissue.

实验室工作人员需具备必要的卫生设备和健康意识，避免生物污染。

i.Personnel involved in processing wearing the appropriate personal protective equipment.

参与实验室操作过程的工作人员要穿戴好个人防护装备。

e.Supervisor/ Director assure that personnel, resources, facilities, equipment, materials and methodologies are available as scheduled.

管理人/主管要确保工作人员、资源、设备、仪器、材料和技术与预期的安排一致，保证实验室正常运营。

f.Director assures that unforeseen circumstances are noted when they occur and corrective actions is taken and documented.

主管确保当一些无法预料的问题发生时，应该采取的补救措施已经安排好。

11.Records

记录

a.Summaries of training and experience and job description required maintained?

人员培训记录和工作性质描述的记录需要更新。

b.Records and report of the maintenance, calibration, inspection and use of equipment and facilities.

保养、校准、检验和仪器设备使用的记录和报告。

i.Temperature and/or humidity controls, ventilation and air filtration, cleaning and disinfection.

温度和湿度控制，通风情况，过滤情况，清洁情况和消毒情况的记录。

c.Records on the supplies and reagents.

耗材和试剂的记录。

d.Documented training recorded and maintained.

培训的记录和更新。

i.Current summary of training and experience and job description for each individual.

当前每个员工的培训情况和工作性质描述。

e.Original records retained?

原始记录供查？

f.Data generated in the laboratory properly recorded.

实验室记录是否恰当？

g.Cryostorage sample records properly maintained?

冷冻储存记录是否及时的更新？

h.Is there a database established of data.

是否建立数据库？

12.Personal Protective Equipment

个人防护

a.Proper personal protective equipment being utilized.

恰当的个人防护装备正在使用。

b.Is the PPE utilized to reduce the risk of communicable disease transmission and microbial contamination?

是否使用个人防护设备（PPE）来降低传染病传染和微生物污染的风险性？