-
101 of 121
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
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
< br>accurately
你的工作是否足够安全、准确地履行你的职责
GLOBALEUROPEANA
TMNETWORK
泛欧
ATM
网；<
/p>
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
102 of 121
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<
/p>
）。实验室设计；认可指南
-
第二版。<
/p>
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，
P
A 19087-1898
，美国，
2007
< br>。
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<
/p>
/
生物经理
6.
Section
supervisors
第监事
7.
Freezer
storage area
冷库储存区
8.
Ambient temperature
storage
环境温度存储
9.
Lavatories
厕所
10.
L
ibrary, conference and
meeting room
图书馆，会议和会议室
11.
P
ersonnel lounge and
lockers
人员休息室、储物柜
ENVIRONMENT
环境
Ambient or room temperature and
humidity must be controlled to minimize
evaporation of specimens and reagents,
to provide proper growth conditions for
room temperature incubation of
cultures, and not to interfere with the
performance
of electronic
instruments.
环境或室内温度和湿度必须控制，
以尽量减少试样和试剂的蒸发量，以提供适当
的生长条件，室温培养的文化，而不是电子
乐器的性能。
Climate
Control
控制气候
Phase
I
The
room temperature and humidity are adequately
controlled in all
seasons.
在所
有季节里，房间的温度和湿度都得到了充分的控制。
Evidence of Compliance
遵守的依据
?
Temperature and
humidity records, if specific ranges are required
for instrument and/or reagent use
温度和湿度记录，如果特定的
范围是必需的仪器和
/
或试剂使用
?
HVAC
Phase
I
HVAC units, if present, are
properly serviced and functioning to
maintain appropriate compressor
activity.
暖通空调机组
，如果存在，正确的维修和运作，以保持适当的压
缩机活动。
Evidence of
Compliance:
遵守的依据
?
Records of
maintennce
?
保养记录
Hallway Obstructions
走廊障碍物
Phase
II
Passageways
are unobstructed.
通道通畅。
Environment
Maintenance
环境维护
Phase I
Floors, walls and ceilings
are clean and well-maintained.
地板、墙壁和天花板都很干净，保养得很好。
Laboratory General
Checklist
Environment Maintenance
Phase
环境维护
I
Bench tops, cupboards, drawers and
sinks are clean and
well-
maintained.
台面，橱柜，抽屉和水槽的清洁和保养。
Environment Maintenance
Phase
II
There are oxygen sensors or
sufficient airflow to prevent
asphyxiation in areas where liquid
nitrogen is used.
有氧传感器或足够的气流，防止窒息的地方是用液态氮。
COMMUNICATIONS
通信
Communications within the biorepository
should be appropriate for the size and
scope of the biorepository. Messages
should be transferred efficiently to all
sections.
在生物通信应适当的生物的大小和范围。信息应该有效地传送到
所有
的部分。
**REVISED** 07/28/2015
Hand-Off
Communication
手断通讯
Phase
I
The biorepository
implements a procedure for effective
“hand
-
off”
communication.
建立并实施有效的程序“交班”通信。
NOTE: The biorepository
must have a procedure for communicating
information about pending processes,
quality or operational issues when
responsibility is “handed off” from one
person to another, such as at a
change
in shift, or when the responsibility for a case is
transferred from
one pathologist to
another. The procedure should include provision
for
asking and responding to
questions.
103 of
121
注：该生物必须有一个程序挂
起过程信息沟通，质量或操作问题时，
责任是“移交”从一个人到另一个，这样的在移的
变化，或者当一个
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