醫(yī)學(xué)報(bào)告中英翻譯版

1、101of121Laboratory General Checklist07.28.2022 試驗(yàn)室常規(guī)檢查表supervisory review of work, reassignment of duties, or other actions deemed appropriate by the biorepository director.工作的監(jiān)視檢查，安排職責(zé)，或?qū)嵭衅渌袆樱盟剖巧餇庌q者們最欣賞的Evidence of Compliance合規(guī)的依據(jù):Recordsofcorrectiveactiontoincludeevidenceofretrainingandreassess

2、mentofcompetency訂正措施包括培訓(xùn)和評估力量證據(jù)記錄，記錄關(guān)于培訓(xùn)和評估的勝任的樂觀行為Inspector Instructions:檢查員指示：PHYSICAL FACILITIES物質(zhì)設(shè)施；Floor plan and equipment locations 地面打算及設(shè)備位置BuildingAutomationSystem(BAS),ifavailable假設(shè)有可能，可以建筑自動化系統(tǒng)BASPhysical facility (adequate space, acceptable temperature/humidity, areas clean, adequate sto

3、rage areas, adequate emergency power)物理設(shè)施適當(dāng)?shù)目臻g，可以承受的溫度/濕度，清潔，充分的存儲區(qū)域，足夠 的應(yīng)急電源Perimeter security and access security to specific specimencollections確保周邊安全性和特定的樣本集的訪問安全I(xiàn)s the work area sufficient for you to perform your duties safelyand accurately?你的工作是否足夠安全、準(zhǔn)確地履行你的職責(zé)？GEN.84000GENGLOBALEUROPEANATMNETW

4、ORKATM網(wǎng)；Restricted Access限制訪問Phase I段落一Access to the biorepository is restricted to authorizedindividuals.、進(jìn)入生物是被制止的授權(quán)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：這可能是通過使用訪問代碼安全代碼，用戶代碼，限制個(gè)人進(jìn)入這些領(lǐng)域，他們被授權(quán)進(jìn)入或使用。需要授權(quán)為獲得：Biorepository 生物Specimens,aliquotsandany extractsthereof 標(biāo)本，樣品和任何其提取物Participant/client and study records/客戶和學(xué)習(xí)記錄Access codes/user codes must be maintained and current (e.g.inactivated when employment of an au

6、thorized individual”s employment ends)/用戶代碼必需保持和當(dāng)前如授權(quán)個(gè)人的就業(yè)完畢時(shí)，滅活。SPACE空間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.在空間上的缺乏之處應(yīng)記錄，所以有鼓勵(lì)改善。在空間上的缺乏被認(rèn)為是次要 的，除非他們是如此嚴(yán)峻，以干擾質(zhì)量的工作或質(zhì)量把握把握活動和安全，在這II 期缺乏。作為生物行動擴(kuò)大隨著時(shí)間的推移，我相空間缺乏可能成為二期缺乏TH的時(shí)間下

8、一次檢查GEN.84100Adequate Space充分的空間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.護(hù)理效勞不妥協(xié)。REFERENCESR 工具書類MortlandKK,ReddickJH.Laboratoryd

9、esignfortoday”stechnologiesandmarketplace.LabMed. 1997;28:332-336莫特蘭公司，雷迪克 JH。試驗(yàn)室設(shè)計(jì)為今日的技術(shù)和市場。 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.臨床和試驗(yàn)室標(biāo)準(zhǔn)協(xié)會CLSI。試驗(yàn)室設(shè)計(jì)；認(rèn)可指南-其次版。qms04-a2 CLSI 文件。1-56238-631-x。臨床和試驗(yàn)室標(biāo)準(zhǔn)爭辯所，940 西峪道，2500，韋恩，PA 19087-1898，美國，2022。GEN.84200Adequate SpacePhase IAll of the following areas have sufficient space and are locatedso there is no hindrance to

11、the work.全部以下的區(qū)域有足夠的空間和位置，所以沒有任何阻礙的工作。Biorepository director生物董事Staff pathologists and researchers病理學(xué)家和爭辯人員Biorepository technician生物技術(shù)人員Clerical staff文書工作人員Chieftechnologist/biorepositorymanager生物經(jīng)理Section supervisors第監(jiān)事Freezer storage area冷庫儲存區(qū)Ambient temperature storage環(huán)境溫度存儲Lavatories廁所Library,c

12、onferenceandmeetingroom和會議室Personnel lounge and lockers人員休息室、儲物柜ENVIRONMENT環(huán)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.環(huán)境或室內(nèi)溫度和濕度必需把握，以盡量削減試樣和試劑的蒸發(fā)量，以供給適當(dāng)?shù)纳L條件，室溫培育的文化，而不是電子樂器的性能。GEN.84300Climate Control把握氣候Phase IThe room temperature and humidity are adequately controlled inall seasons.。Evidence of Compliance遵守的依據(jù)Temperature and humidity records, if specific ranges are required fo

14、r instrument and/or reagent use 溫度和濕度記錄，假設(shè)特定的范圍是必需的儀器和/或試劑使用GEN.84400HVACe IHVAC units, if present, are properly serviced and functioning to maintain appropriate compressor activity.縮機(jī)活動。Evidence of Compliance:遵守的依據(jù)Records of maintenncePhas保養(yǎng)記錄GEN.845Hallway Obstructions00走廊障礙物Passageways are unobst

15、ructed.通道通暢。Phase IIGEN.846Environment Maintenance00環(huán)境維護(hù)Floors, walls and ceilings are clean and well-maintained.地板、墻壁和天花板都很干凈，保養(yǎng)得很好。Phase I103103 of121Laboratory General07.28.2Checklist015GEN.84700Environment MaintenancePhas環(huán)境維護(hù)e IBench tops, cupboards, drawers and sinks are cleanand well-maintaine

16、d.臺面，櫥柜，抽屜和水槽的清潔和保養(yǎng)。GEN.84800Environment MaintenancePhase IIThere are oxygen sensors or sufficient airflow to preventasphyxiation in areas where liquid nitrogen is used.有氧傳感器或足夠的氣流，防止窒息的地方是用液態(tài)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. 在生物通信應(yīng)適當(dāng)?shù)纳锏拇笮『头秶Ｐ畔?yīng)當(dāng)有效地傳送到全部的局部。*REVISED* 07/28/2022 GEN.84900Hand-Off Communication手?jǐn)嗤ㄓ峆hase IThe biorepository implements a procedure for effective “hand-off”communication.建立并實(shí)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：該生物必需有一個(gè)程序掛起過程信息溝通，質(zhì)量或操作問題時(shí)，責(zé)任是“移交”從一個(gè)人到另一個(gè)，這樣的在移的變化，或者當(dāng)一個(gè)案件的責(zé)任是從一家轉(zhuǎn)移到另一個(gè)。程序應(yīng)包括詢問和答復(fù)以下問題的規(guī)定。Evidence of Compliance:Logs or message boards showing communication between shiftsor departments 顯示移動或部門之間的通信的日志或消息板GEN.85000Biospecimen Chain of Custody

20、、生物保管鏈Phase IThe biorepository implements a policy and procedure fortracking biospecimen chain of custody.跟蹤監(jiān)管鏈的政策和程序NOTE: Chain of custody is used to maintain the integrity of thebiospecimen by providing records of the control, transfer, and analysis of biospecimens.注：保管鏈?zhǔn)怯脕砉┙o把握，轉(zhuǎn)賬記錄保持生物的完整性，并分析生物檢

21、材。The intent of this requirement is to have a system in place to ensure adequate records of the “l(fā)ife 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這個(gè)要求的目的是有一個(gè)系統(tǒng)來保證“生活史足夠的記錄”的生物。保管鏈供給了一個(gè)可追溯的記錄，保證不連續(xù)的在生物標(biāo)本，從最初的采集到最終處置的容器把握。這是實(shí)現(xiàn)準(zhǔn)確和有效的標(biāo)簽，跟蹤和報(bào)告。Chain of custody requires that from the moment the biospecimen is received every transfer between departments berecorded. 監(jiān)管鏈的要求，從目前的生物是每收

23、到一個(gè)部門之間的轉(zhuǎn)移記錄。Evidence of Compliance:Logs or message boards showing specimen movement throughbiorepository AND日志或留言板通過生物標(biāo)本運(yùn)動表現(xiàn)Work flow diagrams 工作流程圖INVENTORY AND STORAGE OF SUPPLIES庫存和庫存的儲存GEN.85100Inventory ControlPhase IThere is an effective supply inventory control system inoperation.有一個(gè)有效的供給庫存把

24、握系統(tǒng)的運(yùn)作。104of121Laboratory General Checklist07.28.2022 NOTE: An effective inventory control system minimizes emergency requisitions and shortages of supplies.注：一個(gè)有效的庫存把握系統(tǒng)最大限度地削減物資應(yīng)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 一個(gè)寫程序，具體介紹了相關(guān)人員，在訂購時(shí)需要和層次的緩沖庫存REFERENCES 工具書類Chapman J. Saving money with computerized materialsmanagement. Advance/Lab. 2022:8(9):16-18查普曼J.存錢電腦資料治理。提前/20229：16-18GEN.85200Intrabiorepository Storageintrabiorepository存儲Phase IThe intrabiorepository storage area is sufficient and f

26、ree of clutter. intrabiorepositoryPOWER 能源*REVISED* 07/28/2022 GEN.85300Emergency Power緊急備用動力；Phase IIEmergency power is adequate for the functioning of thebiorepository.應(yīng)急電源是足夠的生物功能。NOTE: Emergency power supply must be adequate for refrigerators, freezers, incubators, etc., to ensure preservation o

27、f specimens.注：應(yīng)急電源必需有足夠的冰箱，冰柜，孵化器，等，確保保存的標(biāo)本。*REVISED* 07/28/2022 GEN.85400Emergency Power Load Testing應(yīng)急電源負(fù)載測試Phase IILoad testing is performed to ensure that emergency power isadequate for the functioning of the biorepository.應(yīng)急電源是足夠的生物功能。NOTE: Emergency power supply must be adequate for refrigerat

28、ors,freezers, incubators, etc. to ensure preservation of specimens注：應(yīng)急電源必需有足夠的冰箱，冰柜，孵化器，以確保保存標(biāo)本等。GEN.85500Contingency Plans應(yīng)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.時(shí)，備用發(fā)電機(jī)不能運(yùn)行，

29、假設(shè)沒有足夠的燃料來操作發(fā)電機(jī)。Evidence of Compliance:Written contingency plan AND 書面應(yīng)急打算Schedule of fuel deliveries燃料交付時(shí)間表SAFETY安全Requirements in this section cover the general safety program for the entirebiorepository.在這一局部要求掩蓋整個(gè)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.關(guān)于消防安全，假設(shè)清單要求的沖突與有管轄權(quán)的機(jī)關(guān)的規(guī)定即國家和地方消防標(biāo)準(zhǔn)，具有法律規(guī)定的權(quán)力語言優(yōu)先。105of121Laboratory General Checklist07.28.2022 SAFETY POLICIES, PROCEDURES, AND RECORDS安全政策，程序和記錄In

31、spector Instructions:檢查員指示：Sampling of safety policies and procedures 安全政策和程序抽樣Adequate emergency lighting充分的應(yīng)急照明How are your biorepository”s safe work practices reviewed? 你的生物的安全工作實(shí)踐的回憶嗎？Is there a specific example of an occupational injury or illness that required medical treatment? What steps wer

32、etaken to address the incident?是否有一個(gè)具體的例子，一個(gè)職業(yè)損害或疾病，需要醫(yī)療？實(shí)行了哪些措施來解決這一大事？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任何職業(yè)損害或疾病，需

33、要治療，進(jìn)一步評價(jià)領(lǐng)導(dǎo)的反響，訂正措施，后續(xù)程序，并實(shí)行確保安全的補(bǔ)充措施在工作場所GEN.856Safety Policy and Procedure ApprovalPhas00安全政策和程序?qū)徟鶷he biorepository director or designee reviews and approves allchanges to the safetypolicies and procedures beforeimplementation.該生物主任或指定人員審核和批e II準(zhǔn)的安全全部的變化policies and procedures beforeimplementation.政策和程序?qū)嵤┣啊?REVISED* 07/28/2022 GEN.857Safety Policy and Procedure AvailabilityPhas00安全政策和