医学报告 中英翻译版.pdf

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Laboratory General Checklist 07.28.2015

实验室常规检查表

supervisory review of work, reassignment of duties, or other actions

deemed appropriate by the biorepository director.

工作的监督检查，

分配职责，或采取其他行 动，似乎是生物研究者们最欣赏的

Evidence of Compliance

合规的依据

:

?

Records

of

corrective

action

to

include

evidence

of

retraining and reassessment of competency

?

纠正措 施包括培训和评估能力证据记录，记录关于培训和

评估的胜任的积极行为

Inspector Instructions:

检查员指示：

●

Floor plan and equipment locations

地面计划及设备位置

●

Overview of Building Automation System (BAS), if available

如

果有可能，可 以建筑自动化系统（

BAS

）

●

PHYSICAL FACILITIES

物质设施；

Physical

facility

(adequate

space,

acceptable

temperature/humidity,

areas

clean,

adequate

storage

areas,

adequate

emergency

power)

物理设施（适当的空

间，可以接受的温度

/

湿度，清洁，充足的存储区域，足够

的应 急电源）

●

Perimeter

security

and

access

security

to

specific

specimen

collections

●

确保周边安全性和特定的样本集的访问安全

●

Is the work area sufficient for you to perform your duties safely

and

accurately ?

你的工作是否足够安全、准确地履行你的职

责？

GEN.84000GEN < /p>

GLOBALEUROPEANATMNETWORK

泛欧

ATM

网；

Restricted Access

限制访问

Phase I

段落一

Access to the biorepository is restricted to authorized

individuals.

、

进入生物是被禁止的授权人。

NOTE: This may be accomplished through the use of access codes

(security codes, user codes) that limit individuals' access to those

areas they are authorized to enter or use. Authorization is required

for access to the

注：这 可能是通过使用访问代码（安全代码，用户代码），限制个人

进入这些领域，他们被授权 进入或使用。需要授权为获得：

1.

Biorepository

生物

2.

Specimens,

aliquots

and

any

extracts

thereof

标 本，样品和

任何其提取物

3.

Participant/client and study records

参与者

/

客户和学习记录

Access codes/user codes must be maintained and current (e.g.

inactivated when employment of an authorized individual's

employment ends)

接入码

/

用户代码必须保 持和当前（如授权个人的就业结束时，灭

活）。

SPACE

空间

Deficiencies in space should be recorded so there is incentive to improve.

Deficiencies in space are regarded as minor unless they are so severe as to

interfere with the quality of work or quality control activities and safety, in which

case they become a Phase II deficiency. As biorepository operations expand

over time, Phase I space deficiencies may become Phase II deficiencies by the

time of the next inspection.

在空间上的不足之处应记录，所以 有激励改善。在空间上的不足被认为是次要

的，除非他们是如此严重，以干扰质量的工作 或质量控制控制活动和安全，在这

种情况下，他们成为一个

II

期不足。作为生物行动扩大随着时间的推移，我相空

间不足可能 成为二期不足，

TH

的时间下一次检查

GEN.84100

Adequate Space

充足的空间

Phase II

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Laboratory General Checklist 07.28.2015

The general biorepository has adequate, conveniently

located space so the quality of work, safety of personnel,

and patient care services are not compromised.

一般的生物有足够的空间，方便工作人员的安全，质量，和 病人

护理服务不妥协。

REFERENCESR

工具书类

1)

Mortland

KK,

Reddick

JH.

Laboratory

design

for

today's

technologies and marketplace.

Lab Med.

1997;28:332-336

莫特兰公司，雷迪克

JH< /p>

。实验室设计为今天的技术和市场。

1997

28:332-336

；

Clinical and Laboratory Standards Institute (CLSI). Laboratory Design;

Approved Guideline - Second Edition. CLSI Document QMS04-A2. (ISBN 1-

56238-631-X). Clinical and Laboratory Standards Institute, 940 West Valley

Road, Suite 2500, Wayne, PA 19087-1898, USA, 2007.

临床和实验室标准协会（

CLSI< /p>

）。实验室设计；认可指南

-

第二版。< /p>

qms04-a2

CLSI

文件。（书 号

1-56238-631-x

）。临床和实验室标准研究所，

940

西峪道，

套房

< br>2500

，韦恩，

PA 19087-1898