医学报告中英翻译版pdf

1、101 of 121实验室常readLaboratory Gen eral Checklist规检查表supervisory review of work, reassig nment of duties, or other acti ons 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Evide nee of Complia nee合规的依据：? Records of corrective acti on to in elude evide nee of retrai

2、ning and reassessme nt of compete ncy?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PHY SICAL FACILITIES物质设施；In spector In structi ons: 检查员指示： Floor pla n and equipme nt locati ons 地面计划及设备位置 Overview of Buildi ng Automation System (BAS), if available 如果有 可能，可以建筑自动化系统(BAS)Physical facility (adequate space, acc

3、eptable temperature/humidity, areas clean, adequate storage areas, adequate emerge ncy 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111 Perimeter security and access security to specific specimen collecti ons确保周边安全性和特定的样本集的访问安全11111ASK1111Is the work area sufficie nt for you to perform your duties

4、safely and弋 乡；accurately你的工作是否足够安全、准确地履行你的职责GLOBALEUROPEANATMNETWO泛欧 ATM 网；Restricted Access 限制访问PhaseI 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 indivi

5、duals 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 A

6、ccess codes/user codes must be maintained and current . inactivated when employment of an authorized individuals 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

7、 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

8、，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 121Laboratory Gen eral Checklist gen eral biorepository has adequate, convenien tly located space so the quality of work, safety of pers onn el,

9、and patie nt 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。REFERENCES 书类1) Mortla nd KK, Reddick JH. Laboratory desig n for todays tech no logies 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。199728:332-336；Cli nical and Laboratory Stan dards In stitute (CLSI). Laborato

10、ry Desig n; Approved Guideli ne - Sec ond Editio n. CLSI Docume nt QMS04-A2. (ISBN X). Cli nical a nd Laboratory Sta ndards In stitute, 940 West Valley Road, Suite 2500, Way ne, PA 190871898, USA, 2007.临床和实验室标准协会(CLS)。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

11、美国，2007。Adequate SpacePhaseIAll of the following areas have sufficient space and are located so there is no hin dra nee 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. Ch

12、ief 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. Lbrary, 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 humidi

13、ty 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

14、控制气候 Phase IThe room temperature and humidity are adequately controlled in all seaso ns在所有季节里，房间的温度和湿度都得到了充分的控制。Evide nee of Complia nee遵守的依据? Temperature and humidity reeords, if speeifie 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HVACIHVAC units, if present

15、, are properly servieed and funetioning to maintain appropriate eompressor aetivity.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。Evide nee of Complia nee 遵守的依据? Reeords of maintennee? 保养记录Hallway Obstruetions走廊障碍物Passageways are unobstrueted.通道通畅。Environment MaintenaneePhasePhase IIPhase I环境维护Floors, walls and

16、 ceilings are clean and well-maintained. 地板、墙壁和天花板都很干净，保养得很好。103 of121Laboratory Gen eral ChecklistEn vir onment MaintenancePhase环境维护IBench tops, cupboards, drawers and sinks are clea n and well- mai ntai ned.台面，橱柜，抽屉和水槽的清洁和保养。En vir onment MaintenancePhaseIIThere are oxyge n sen sors or sufficie nt

17、 airflow to preve nt 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Communi cati ons withi n the biorepository should be appropriate for the size and scope of the biorepository. Messages should be tran sferred efficie ntly to all sectio ns在生物通信应适当的生物的大小

18、和范围。信息应该有效地传送到所有 的部分。*REVISED* 07/28/2015Hand-Off Communication 手断通讯PhaseIThe biorepository implements a procedure for effective-off ”“ handcom muni catio n.建立并实施有效的程序“交班”通信。NOTE: The biorepository must have a procedure for com muni cat ing in formatio n about pending processes, quality or operatio

19、nal issues whe n responsibility is“ handed off ” from one person to another, such as at acha nge in shift, or whe n the resp on sibility for a case is tran sferred from one pathologist to ano ther. The procedure should in clude provisi on forask ing and resp onding to questi ons.注：该生物必须有一个程序挂起过程信息沟通

20、，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I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Biospecimen Chain of Custody 生物保管链PhaseIThe biorepository implements a policy and procedure for tracking bi

21、ospecimen 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

22、 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 这个要求的目

23、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 betwee n departme nts 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 s

24、pecimen 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INVENTOR Y AND STORAGE OF SUPPLIES和库存的储存PhaseInventory ControlThere 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。_104 of 121Laboratory Gen eral Checklist An effective inven tory co

25、n trol system minimizes emergency requisitions and shortages of supplies. :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。Evide nee of Complia nee:? A writte n procedure detaili ng releva nt pers onn el, whe n 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 具书类1) Chapma

26、n 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)： 16-18In trabiorepository Storageintrabiorepository 存储PhaseIThe in trabiorepository storage area is sufficie nt and free of clutter. intrabiorepository存储区域是足够的和无杂波。POWER能源*REVISEDREVIS

27、ED* 07/28/2015Emergency Power Load Testing应急电源负载测试 Phase IILoad test ing is performed to en sure that emerge ncy 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。 07/28/2015Emerge ncy Power 紧急备用动力；PhaseIIEmerge ncy power is adequate for the fun cti oning of the biorepo

28、sitory. 应急电源是足够的生物功能。NOTE: Emerge ncy power supply must be adequate for refrigerators, freezers, in cubators, etc., to en sure preservati on of specime n 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。NOTE: Emergency power supply must be adequate for refrigerators, freezers, incubators, etc. to ensure preservati

29、on 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PhaseContingency Plans 应急计划IIContingency 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 gen erator.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:? Wr

30、itten 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 theAuthority Having Juri

31、sdiction . 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。IIIL*DISCOVER105 of 121Laboratory Gen eral Checklist POLICIES, PROCEDURES, AND RECORDS 安全政策，程序和记录In spector In structi ons: 检查员指示： Sampl

32、i ng of safety policies and procedures安全政策和程序抽样 Adequate emerge ncy light ing 充足的应急照明 How are your biorepositorys safe work practices reviewed 你的生 物的安全工作实践的回顾吗I Is there a specific example of an occupational injury or illness that required medical treatment What steps were taken to address the incid

33、ent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 For any occupational injury or illness that required medical treatme nt, further evaluate leaderships resp on ses, corrective actions, follow-up procedures, and additional measures taken to ensure safetyin 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

34、采取确 保安全的补充措施在工作场所Safety Policy and Procedure Approval 安全政策和程序审批PhaseIIThe biorepository director or desig nee reviews and approves all cha nges to the safety policies and procedures before implementation.该生 物主任或指定人员审核和批准的安全所有的变化policies and procedures before impleme ntatio n. 政策和程序实施前。Safety Policy and Procedure AvailabilityPhase安全政策和程序的可