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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
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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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。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）。实验室设计；认可指南-第二版。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2500，韦恩，PA 19087-1898，美国，2007。
GEN.84200
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 8. Ambient temperature storage环境温度存储 9. Lavatories厕所 10. Library, conference and meeting room图书馆，会议和会议室 11. Personnel 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。
GEN.84300
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
? GEN.84400 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
?
GEN.845Hallway Obstructions
走廊障碍物 00
Passageways are unobstructed.
通道通畅。
GEN.846Environment Maintenance
环境维护 00
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。 保养记录 Phase II Phase I
GEN.84700 Environment Maintenance Phas环境维护 e 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。
GEN.84800
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 GEN.84900
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.
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
案件的责任是从一家转移到另一个。程序应包括询问和回答问题的规定。
Evidence of Compliance:
? Logs or message boards showing communication between shifts or departments显示移动或部门之间的通信的日志或消息板
GEN.85000 Biospecimen Chain of Custody、生物保管链 Phase I The biorepository implements a policy and procedure for
tracking biospecimen chain of custody.建立并实现了一个生物的跟踪监管链的政策和程序
NOTE: Chain of custody is used to maintain the integrity of the biospecimen by providing records of the control, transfer, and analysis of biospecimens.
注：保管链是用来提供控制，转账记录保持生物的完整性，并分析生物检材。
The intent of this requirement is to have a system in place to ensure adequate records of the "life history" of the biospecimen. Chain of custody provides a traceable record that guarantees unbroken control over biospecimens and its containers from initial collection to final disposition. This is achieved with accurate and effective labeling, tracking and reporting.T这个要求的目的是有一个 系统来保证“生活史足够的记录”的生物。保管链提供了一个可追溯的记录，保证不间断的在生物标本，从最初的采集到最终处置的容器控制。这是实现准确和有效的标签，跟踪和报告。
Chain of custody requires that from the moment the
biospecimen is received every transfer between departments be recorded.监管链的要求，从目前的生物是每收到一个部门之间的转移记录。
Evidence of Compliance:
? Logs or message boards showing specimen movement through biorepository AND日志或留言板通过生物标本运动表现
? Work flow diagrams工作流程图
INVENTORY AND STORAGE OF SUPPLIES库存和库存的储存
GEN.85100
Inventory Control
Phase I There is an effective supply inventory control system in
operation.
有一个有效的供应库存控制系统的运作。
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NOTE: An effective inventory control system minimizes emergency requisitions and shortages of supplies.注：一个有效的库存控制系统最大限度地减少物资应急需求和短缺。
Evidence of Compliance:
? A written procedure detailing relevant personnel, when to order supplies and levels of buffer stock required一个写程序，详细介绍了相关人员，在订购时需要和层次的缓冲库存
REFERENCES工具书类
1) Chapman J. Saving money with computerized materials management. Advance/Lab. 1999:8(9):16-18查普曼J.存钱电脑资料管理。提前/实验室1999（9）：16-18
GEN.85200 Intrabiorepository Storage
intrabiorepository存储
Phase I The intrabiorepository storage area is sufficient and free of
clutter. intrabiorepository存储区域是足够的和无杂波。
POWER 能源
**REVISED** 07/28/2015 GEN.85300
Emergency Power紧急备用动力；
Phase II Emergency power is adequate for the functioning of the
biorepository.
应急电源是足够的生物功能。
NOTE: Emergency power supply must be adequate for refrigerators, freezers, incubators, etc., to ensure preservation of specimens.注：应急电源必须有足够的冰箱，冰柜，孵化器，等，确保保存的标本。
**REVISED** 07/28/2015 GEN.85400
Emergency Power Load Testing应急电源负载测试Phase II
Load testing is performed to ensure that emergency power is
adequate for the functioning of the biorepository.负载测试是确保应急电源是足够的生物功能。
NOTE: Emergency power supply must be adequate for refrigerators, freezers, incubators, etc. to ensure preservation of specimens
注：应急电源必须有足够的冰箱，冰柜，孵化器，以确保保存标本
等。
GEN.85500
Contingency Plans应急计划
Phase II Contingency plans are in place in the event that the back-up
generator is not operational and if there is not enough fuel
present to operate the generator.应急计划在发生故障的情况发生
时，备用发电机不能运行，如果没有足够的燃料来操作发电机。 Evidence of Compliance:
? Written contingency plan AND书面应急计划
? Schedule of fuel deliveries ? 燃料交付时间表
SAFETY
安全
Requirements in this section cover the general safety program for the entire biorepository.
在这一部分要求覆盖整个生物一般安全程序。
With respect to fire safety, if a checklist requirement conflicts with regulations of the Authority Having Jurisdiction (i.e. state and local fire codes), the regulations of the Authority Having Jurisdiction take precedence.
关于消防安全，如果清单要求的冲突与有管辖权的机关的规定（即国家和地方消防规范），具有法律规定的权力语言优先。
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Inspector Instructions:
检查员指示： ● Sampling of safety policies and procedures安全政策和程序抽
样
●
●
SAFETY POLICIES, PROCEDURES, AND RECORDS 安全政策，程序和记录 Adequate emergency lighting充足的应急照明
How are your biorepository's safe work practices reviewed?你的生物的安全工作实践的回顾吗？ ● Is there a specific example of an occupational injury or illness that required medical treatment? What steps were taken to address the incident?是否有一个具体的例子，一个职业伤害或疾病，需要医疗？采取了哪些措施来解决这一事件？
●
GEN.856Safety Policy and Procedure Approval Phas
安全政策和程序审批 00 e II
The biorepository director or designee reviews and approves all changes to the safety
policies and procedures before
implementation.该生物主任或指定人员审核和批 For any occupational injury or illness that required medical treatment, further evaluate leadership's responses, corrective actions, follow-up procedures, and additional measures taken to ensure safety in the workplace任何职业伤害或疾病，需要治疗，进一步评价领导的反应，纠正措施，后续程序，并采取确保安全的补充措施在工作场所
准的安全所有的变化
policies and procedures before
implementation.
政策和程序实施前。
**REVISED** 07/28/2015
GEN.857Safety Policy and Procedure Availability Phas
安全政策和程序的可用性 00 e II There are records for the training of all laboratory workers in
safety.所有实验室工作人员安全培训记录
NOTE: A system to ensure that all personnel have read the policies and procedures is required and must form a portion of the
orientation program for new personnel. Posting of specific warnings or hazards as appropriate is urged.
注：系统确保所有人员都已阅读的政策和程序是必需的，必须形成新的人员的方向程序的一部分。在具体的警告或危险RDS是适当的鼓励。
Evidence of Compliance:遵守的证据
Records of personnel review of safety policies and procedures安全
政策和程序的人员审查记录
REFERENCES工具书类
1) Clinical and Laboratory Standards Institute (CLSI). Clinical
Laboratory Safety; Approved Guideline, Third Edition. CLSI
document GP17-A3 [ISBN 1-56238-797-9 (Print); ISBN 1-
56238-798-7 (Electronic)]. Clinical and Laboratory Standards
Institute, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 19087-1898 USA, 2012.
临床和实验室标准协会（CLSI）。临床实验室安全；批准指南，第
三版。CLSI文件gp17-a3 [书号ISBN 1-56238-797-9（打印）；1-
56238-798-7（电子）]。美国临床实验室标准化研究所，940西峪
道，套房1400，韦恩，宾夕法尼亚19087-1898美国，2012。
**REVISED** 07/28/2015 GEN.85800 Safe Work Practices Review工作实践回顾
Phase II There are records of periodic review (at least annually) of safe
work practices to reduce hazards.有定期审查记录（至少每年）
的安全工作实践，以减少危害。