医学报告中英翻译版

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Laboratory General Checklist

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

PHYSICAL FACILITIES

物质设施；

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 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？

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 .

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

Adequate Space 充足的空间

Phase II

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Laboratory General Checklist 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 Med. 1997;28:332-336

莫特兰公司，雷迪克JH。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 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）。实验室设计；认可指南-第二版。qms04-a2 CLSI文件。（书号x）。临床和实验室标准研究所，940西峪道，套房2500，韦恩，PA 19087-1898，美国，2007。

Adequate Space Phase I

All of the following areas have sufficient space and are

located so there is no hindrance to the work.

所有以下的区域有足够的空间和位置，所以没有任何阻碍的工作。

1.Biorepository director生物董事

2.Staff pathologists and researchers 病理学家和研究人员

3.Biorepository technician生物技术人员

4.Clerical staff文书工作人员

5.Chief technologist/biorepository manager首席技师/生

物经理

6.Section supervisors第监事

7.Freezer storage area冷库储存区