臨床級干細(xì)胞實(shí)驗(yàn)室建設(shè)標(biāo)準(zhǔn)中英文對照

1、精選優(yōu)質(zhì)文檔-傾情為你奉上 臨床級干細(xì)胞實(shí)驗(yàn)室建設(shè)標(biāo)準(zhǔn)Rating Scale Definitions評分標(biāo)準(zhǔn)ScaleCompliance Rating，符合狀況評分Execution rating 執(zhí)行狀況評分1No system in place 沒有任何系統(tǒng)No data generated 沒有產(chǎn)生任何數(shù)據(jù)2System with major deficiencies 系統(tǒng)有重大缺陷Major deviations執(zhí)行中有重大偏差3System with minor deficiencies系統(tǒng)有非重大之缺陷Minor deviations執(zhí)行有非重大偏差4System with o

2、ut significant deficiencies系統(tǒng)無明顯缺陷Good with out significant deficiencies執(zhí)行好，無明顯缺陷5System is state of the art系統(tǒng)非常先進(jìn)Excellent執(zhí)行優(yōu)秀System Rating 對系統(tǒng)的評分PracticeObjective 目標(biāo)Compliance rating符合情況評分Execution rating執(zhí)行情況評分Comments評注1Standard Operating Procedures and Methods標(biāo)準(zhǔn)操作規(guī)程和方法22SOPs need to be translate

3、d.SOP需要翻譯2Lab Facilities and Environmental Control實(shí)驗(yàn)室設(shè)施和環(huán)境控制33Facility is of suitable size and layout, however, it does not allow for proper access/egress. No monitoring system is in place.設(shè)施的大小及布局基本合適，但不能滿足恰當(dāng)?shù)倪M(jìn) / 出要求。沒有安裝監(jiān)控系統(tǒng)3Equipment Maintenance and Calibration設(shè)備保養(yǎng)及校準(zhǔn)32The equipment is properly m

4、aintained and used, but no records are available.設(shè)備保養(yǎng)和使用比較恰當(dāng)，但無記錄4Supplies and Reagents Management Control耗材及試劑管理和控制32Supplies and reagents are not properly tracked during use. Records are incomplete.耗材和試劑在使用時缺少恰當(dāng)?shù)挠涗?。記錄不完?Sample Transfer樣品轉(zhuǎn)移33Current SOP needs to be updated to reflect procedure.當(dāng)前的

5、SOP需要更新以反映當(dāng)前的程序6Labeling Controls標(biāo)簽控制32Samples are not appropriately labeled.樣品沒有恰當(dāng)?shù)刭N標(biāo)簽7Storage Requirements存儲控制NA無關(guān)NA無關(guān)8Receipt and Processing of Tissue組織樣品的接受和處理32Samples are processed for autologous use, but the cleaning done between patients is inadequate. 樣品處理的目的是自體使用，但病人之間的清潔不恰當(dāng)9Quality Contro

6、l Program質(zhì)量控制程序21No reports available.沒有質(zhì)量控制報(bào)告10Personnel人員32The lab is appropriately staffs, but no records are available of training or job descriptions. 實(shí)驗(yàn)室人員配置合理，但沒有培訓(xùn)記錄和工作責(zé)任描述11Records記錄22Records are incomplete or lacking.記錄不完整或根本沒有12Personal Protective Equipment人員防護(hù)設(shè)備43The proper PPE is availa

7、ble, but is not utilized to reduce the risk of contamination. 人員防護(hù)設(shè)備存在，但沒有為了減低污染風(fēng)險而使用Assessment Objectives評估目標(biāo)1. Standard Operating Procedures and Methods標(biāo)準(zhǔn)化操作規(guī)程（SOP）和方法a. SOP in writing and available to approved personnel. SOP正確編寫，并且對工作人員來說是切實(shí)可用的。b. Personnel properly performing SOP as stated. 工作人員

8、能夠按照SOP正確操作。c. Are current SOPs being implemented? 當(dāng)前使用的SOP是有效的？2. Lab Facilities and Environmental Control實(shí)驗(yàn)室設(shè)施及環(huán)境控制a. Facility of suitable size and properly maintained.實(shí)驗(yàn)室設(shè)備的匹配性及恰當(dāng)?shù)木S護(hù)。b. Facility divided into separate or defined areas for each operation. 儀器設(shè)備分區(qū)放置及每項(xiàng)操作有專門的區(qū)域。c. Does the facility ma

9、intain a proper access/egress?實(shí)驗(yàn)室的出入口安排恰當(dāng)。d. Proper environmental control for equipment and facilities.實(shí)驗(yàn)室環(huán)境控制安排合理性。e. Facility restricted to authorized personnel.出入實(shí)驗(yàn)室人員的權(quán)限。3. Equipment Maintenance and Calibration設(shè)備維護(hù)和校正a. Equipment properly maintained.儀器設(shè)備的正確維護(hù)。b. Equipment of suitable design and

10、use.儀器設(shè)備合理匹配和使用。c. Proper SOP established for the cleaning, maintenance, testing, calibration, use, and standardization of the equipment established. 建立正確的清潔、維護(hù)、測試、校準(zhǔn)、使用設(shè)備的SOP。4. Supplies and Reagents Management Control耗材和試劑管理控制a. Are reagents and supplies properly labeled with identity, concentrati

11、on, storage requirements and expiration dates? 試劑和耗材是否正確的標(biāo)記？包括名稱、濃度、儲存條件和有效期。b. Are supplies and reagents being properly stored? 試劑和耗材的保存是否恰當(dāng)？c. Are supplies and reagent being properly distributed and tracked during use?耗材和試劑使用時是否正確的編號和記錄？d. Are deteriorated or outdated reagents being used?是否使用過期的試劑

12、？5. Sample Transfer樣品的傳送a. Are samples appropriately labeled for autologous processing?在治療過程中，樣品是否正確的標(biāo)記？b. Samples appropriately transfer in transport cooler/device?樣品傳送過的方法是否恰當(dāng)？保溫箱等設(shè)施的使用？6. Labeling Controls標(biāo)簽控制a. Autologous samples properly labeled with:病人的樣品需要標(biāo)記下面幾項(xiàng)：i. Patient name or code number

13、.病人姓名或代號。ii. Date of birth.出生日期。iii. Contents and collection date or time.內(nèi)含物和收集時間。iv. Volume of samples.樣品的體積。v. Quality of sample.樣品的質(zhì)量。b. Reagents used in processing appropriately labeled?治療過程中使用的試劑是否正確標(biāo)記？7. Storage Requirements儲存要求a. Cells properly handled for cryopreservation.細(xì)胞按照正確的方法低溫儲存。8. R

14、eceipt and Processing of Tissue組織樣品的接受和處理a. Are samples maintained for autologous processing?樣品在治療過程中是否正確處理？9. Quality Control Program質(zhì)量控制程序a. No deviations from approved protocols or SOPs are made without proper authorization and documentation. 診斷記錄中沒有出現(xiàn)變異情況或在沒有經(jīng)過審定和證實(shí)的情況下制定SOPs。b. Procedure and re

15、ports available upon request. 操作過程和報(bào)告的有效性。10. Personnel人員a. Personnel should have the necessary education, experience, and training to ensure competent performance of assigned functions. 工作人員應(yīng)該有適當(dāng)?shù)慕逃尘啊⒔?jīng)驗(yàn)和培訓(xùn)，保證能夠完成相應(yīng)的工作。b. Personnel should perform only those activities for which they are qualified a

16、nd authorized.工作人員只能去完成他們能夠勝任的工作。c. Sufficient number of personnel to perform the procedures in a timely manner.實(shí)驗(yàn)室工作人員的數(shù)量能夠保證實(shí)驗(yàn)室的工作及時有效地完成。d. Personnel take necessary sanitation and health precautions to avoid contamination of tissue. 實(shí)驗(yàn)室工作人員需具備必要的衛(wèi)生設(shè)備和健康意識，避免生物污染。i. Personnel involved in processin

17、g wearing the appropriate personal protective equipment. 參與實(shí)驗(yàn)室操作過程的工作人員要穿戴好個人防護(hù)裝備。e. Supervisor/ Director assure that personnel, resources, facilities, equipment, materials and methodologies are available as scheduled.管理人/主管要確保工作人員、資源、設(shè)備、儀器、材料和技術(shù)與預(yù)期的安排一致，保證實(shí)驗(yàn)室正常運(yùn)營。f. Director assures that unforeseen

18、 circumstances are noted when they occur and corrective actions is taken and documented. 主管確保當(dāng)一些無法預(yù)料的問題發(fā)生時，應(yīng)該采取的補(bǔ)救措施已經(jīng)安排好。11. Records記錄a. Summaries of training and experience and job description required maintained?人員培訓(xùn)記錄和工作性質(zhì)描述的記錄需要更新。b. Records and report of the maintenance, calibration, inspection and use of equipment and facilities. 保養(yǎng)、校準(zhǔn)、檢驗(yàn)和儀器設(shè)備使用的記錄和報(bào)告。i. Temperature and/or humidity controls, ventilation and air filtration, cleaning and disinfection.溫度和濕度控制，通風(fēng)情況，過濾情況，清潔情況和消毒情況的記錄。c. Records on the supplies and reagents. 耗材和試劑的記錄。d. Docum