医学报告中英翻译版

1、101of121Laboratory General Checklist07.28.2022 试验室常规检查表supervisory review of work, reassignment of duties, or other actions deemed appropriate by the biorepository director.工作的监视检查，安排职责，或实行其他行动，好似是生物争辩者们最欣赏的Evidence of Compliance合规的依据:Recordsofcorrectiveactiontoincludeevidenceofretrainingandreassess

2、mentofcompetency订正措施包括培训和评估力量证据记录，记录关于培训和评估的胜任的乐观行为Inspector Instructions:检查员指示：PHYSICAL FACILITIES物质设施；Floor plan and equipment locations 地面打算及设备位置BuildingAutomationSystem(BAS),ifavailable假设有可能，可以建筑自动化系统BASPhysical facility (adequate space, acceptable temperature/humidity, areas clean, adequate sto

3、rage areas, adequate emergency power)物理设施适当的空间，可以承受的温度/湿度，清洁，充分的存储区域，足够 的应急电源Perimeter security and access security to specific specimencollections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 safelyand accurately?你的工作是否足够安全、准确地履行你的职责？GEN.84000GENGLOBALEUROPEANATMNETW

4、ORKATM网；Restricted Access限制访问Phase I段落一Access to the biorepository is restricted to authorizedindividuals.、进入生物是被制止的授权人。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. Author

5、ization 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：Biorepository 生物Specimens,aliquotsandany extractsthereof 标本，样品和任何其提取物Participant/client and study records/客户和学习记录Access codes/user codes must be maintained and current (e.g.inactivated when employment of an au

6、thorized individual”s employment ends)/用户代码必需保持和当前如授权个人的就业完毕时，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,

7、in whichcase they become a Phase II deficiency. As biorepository operations expandover time, Phase I space deficiencies may become Phase II deficiencies by thetime of the next inspection.在空间上的缺乏之处应记录，所以有鼓励改善。在空间上的缺乏被认为是次要 的，除非他们是如此严峻，以干扰质量的工作或质量把握把握活动和安全，在这II 期缺乏。作为生物行动扩大随着时间的推移，我相空间缺乏可能成为二期缺乏TH的时间下

8、一次检查GEN.84100Adequate Space充分的空间Phase II102of121Laboratory General Checklist07.28.2022 The general biorepository has adequate, conveniently located space so the quality of work, safety of personnel,and patient care services are not compromised.护理效劳不妥协。REFERENCESR 工具书类MortlandKK,ReddickJH.Laboratoryd

9、esignfortoday”stechnologiesandmarketplace.LabMed. 1997;28:332-336莫特兰公司，雷迪克 JH。试验室设计为今日的技术和市场。 199728:332-336；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 Ins

10、titute, 940 West Valley Road,Suite2500,Wayne,PA19087-1898,USA,2022.临床和试验室标准协会CLSI。试验室设计；认可指南-其次版。qms04-a2 CLSI 文件。1-56238-631-x。临床和试验室标准争辩所，940 西峪道，2500，韦恩，PA 19087-1898，美国，2022。GEN.84200Adequate SpacePhase IAll of the following areas have sufficient space and are locatedso there is no hindrance to

11、the work.全部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。Biorepository director生物董事Staff pathologists and researchers病理学家和争辩人员Biorepository technician生物技术人员Clerical staff文书工作人员Chieftechnologist/biorepositorymanager生物经理Section supervisors第监事Freezer storage area冷库储存区Ambient temperature storage环境温度存储Lavatories厕所Library,c

12、onferenceandmeetingroom和会议室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 minimizeevaporation of specimens and reagents, to provide proper growth conditionsfor room temperature incubation of cultures, and not to interfere with the per

13、formance of electronic instruments.环境或室内温度和湿度必需把握，以尽量削减试样和试剂的蒸发量，以供给适当的生长条件，室温培育的文化，而不是电子乐器的性能。GEN.84300Climate Control把握气候Phase IThe room temperature and humidity are adequately controlled inall seasons.。Evidence of Compliance遵守的依据Temperature and humidity records, if specific ranges are required fo

14、r instrument and/or reagent use 温度和湿度记录，假设特定的范围是必需的仪器和/或试剂使用GEN.84400HVACe IHVAC units, if present, are properly serviced and functioning to maintain appropriate compressor activity.缩机活动。Evidence of Compliance:遵守的依据Records of maintenncePhas保养记录GEN.845Hallway Obstructions00走廊障碍物Passageways are unobst

15、ructed.通道通畅。Phase IIGEN.846Environment Maintenance00环境维护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。Phase I103103 of121Laboratory General07.28.2Checklist015GEN.84700Environment MaintenancePhas环境维护e IBench tops, cupboards, drawers and sinks are cleanand well-maintaine

16、d.台面，橱柜，抽屉和水槽的清洁和保养。GEN.84800Environment MaintenancePhase IIThere are oxygen sensors or sufficient airflow to preventasphyxiation 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 sizeand scope of the

17、 biorepository. Messages should be transferred efficientlyto all sections. 在生物通信应适当的生物的大小和范围。信息应当有效地传送到全部的局部。*REVISED* 07/28/2022 GEN.84900Hand-Off Communication手断通讯Phase IThe 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 hav

18、e a procedure for communicatinginformation about pending processes, quality or operational issueswhen responsibility is “handed off” from one person to another, suchas at a change in shift, or when the responsibility for a case is transferred from one pathologist to another. The procedure shouldincl

19、ude provision for asking and responding to questions.注：该生物必需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。程序应包括询问和答复以下问题的规定。Evidence of Compliance:Logs or message boards showing communication between shiftsor departments 显示移动或部门之间的通信的日志或消息板GEN.85000Biospecimen Chain of Custody

20、、生物保管链Phase IThe biorepository implements a policy and procedure fortracking biospecimen chain of custody.跟踪监管链的政策和程序NOTE: Chain of custody is used to maintain the integrity of thebiospecimen by providing records of the control, transfer, and analysis of biospecimens.注：保管链是用来供给把握，转账记录保持生物的完整性，并分析生物检

21、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 initialcollection to final disposition. This is a

22、chieved with accurate andeffective 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。保管链供给了一个可追溯的记录，保证不连续的在生物标本，从最初的采集到最终处置的容器把握。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 berecorded. 监管链的要求，从目前的生物是每收

23、到一个部门之间的转移记录。Evidence of Compliance:Logs or message boards showing specimen movement throughbiorepository 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.85100Inventory ControlPhase IThere is an effective supply inventory control system inoperation.有一个有效的供给库存把

24、握系统的运作。104of121Laboratory General Checklist07.28.2022 NOTE: An effective inventory control system minimizes emergency requisitions and shortages of supplies.注：一个有效的库存把握系统最大限度地削减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 buf

25、fer stock required 一个写程序，具体介绍了相关人员，在订购时需要和层次的缓冲库存REFERENCES 工具书类Chapman J. Saving money with computerized materialsmanagement. Advance/Lab. 2022:8(9):16-18查普曼J.存钱电脑资料治理。提前/20229：16-18GEN.85200Intrabiorepository Storageintrabiorepository存储Phase IThe intrabiorepository storage area is sufficient and f

26、ree of clutter. intrabiorepositoryPOWER 能源*REVISED* 07/28/2022 GEN.85300Emergency Power紧急备用动力；Phase IIEmergency power is adequate for the functioning of thebiorepository.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 o

27、f specimens.注：应急电源必需有足够的冰箱，冰柜，孵化器，等，确保保存的标本。*REVISED* 07/28/2022 GEN.85400Emergency Power Load Testing应急电源负载测试Phase IILoad testing is performed to ensure that emergency power isadequate 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 refrigerat

28、ors,freezers, incubators, etc. to ensure preservation of specimens注：应急电源必需有足够的冰箱，冰柜，孵化器，以确保保存标本等。GEN.85500Contingency Plans应急打算Phase IIContingency plans are in place in the event that the back-upgenerator is not operational and if there is not enough fuelpresent to operate the generator.时，备用发电机不能运行，

29、假设没有足够的燃料来操作发电机。Evidence of Compliance:Written contingency plan AND 书面应急打算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 entirebiorepository.在这一局部要求掩盖整个生物一般安全程序。With respect to fire safety, if a checklist requirement conflicts with reg

30、ulations ofthe 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，假设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标准，具有法律规定的权力语言优先。105of121Laboratory General Checklist07.28.2022 SAFETY POLICIES, PROCEDURES, AND RECORDS安全政策，程序和记录In

31、spector Instructions:检查员指示：Sampling of safety policies and procedures 安全政策和程序抽样Adequate emergency lighting充分的应急照明How are your biorepository”s safe work practices reviewed? 你的生物的安全工作实践的回忆吗？Is there a specific example of an occupational injury or illness that required medical treatment? What steps wer

32、etaken to address the incident?是否有一个具体的例子，一个职业损害或疾病，需要医疗？实行了哪些措施来解决这一大事？For any occupational injury or illness that required medicaltreatment, further evaluate leadership”s responses, corrective actions, follow-up procedures, and additional measures taken to ensure safety in the workplace任何职业损害或疾病，需

33、要治疗，进一步评价领导的反响，订正措施，后续程序，并实行确保安全的补充措施在工作场所GEN.856Safety Policy and Procedure ApprovalPhas00安全政策和程序审批The biorepository director or designee reviews and approves allchanges to the safetypolicies and procedures beforeimplementation.该生物主任或指定人员审核和批e II准的安全全部的变化policies and procedures beforeimplementation.政策和程序实施前。*REVISED* 07/28/2022 GEN.857Safety Policy and Procedure AvailabilityPhas00安全政策和