卫生部--自体免疫细胞(T细胞、NK细胞)治疗技术管理规范.doc

reform results, economy, and political system, and culture system, and social system, and discipline check system, and party of construction system reform solid advance, tax, and financial, and price, and administrative approval, and State-owned enterprises, and ecological civilization, important field and key link reform made major progress, market in resources configuration in the of decisive role significantly enhanced, Unprecedented burst of momentum and vitality of economic and social development. XI General Secretarys speech in this regard include the reform only when there is no complete, the notes on the 18 session of ideas into the partys spirit of the reforms more difficult to move forward, the increasing use of the Socialist system with Chinese characteristics such as the ability to run the country. 4. with regard to promoting sustained and healthy economic development. Face complex changeable of international situation and difficult heavy of domestic reform development stable task, XI General Secretary made China economic development into new normal of science judge, proposed innovation, and coordination, and green, and open, and shared five big development concept, implementation macro policy to stability, and industry policy to associate, and micro policy to live, and reform policy to real, and social policy to backing five big pillar sex policy, vigorously advance supply side structural reform, new concept, achieved has 2013 to 2015 during, Domestic production total annual growth 7.3%, obviously fast Yu earlier world economic 2.3% of annual growth, on world economic growth of contribution over 25%, tertiary industry accounted for domestic production total share over 50%, eventually consumption on economic growth of contribution rate reached 66%, economic structure adjustment made important progress, development of quality and benefits significantly upgrade, China economic show out huge of swing room and broad of development prospects. This aspects XI General Secretary of speech main including economic growth must is real and no water of growth improve open type economic level see missing of hand and see have see of hand are to with good speed up from elements drive, and investment scale drive development mainly to to innovation drive development mainly of change active promoted China energy production and consumption revolution,. 5. with regard to building the rule of law in China. 18 big yilai, Central tightly around full advance law ruling, put party of led, and people masters, and law ruling organic unified up, insisted law ruling, and law ruling, and law administrative common advance, insisted rule of law national, and rule of law Government, and rule of law social one construction, full advance science legislation, and strictly law enforcement, and just judicial, and universal law-abiding, China features socialist legal system further sound perfect, leaders at all levels cadres using rule of law thinking and rule of law way deepening reform, and附件3自体免疫细胞（T细胞、NK细胞）治疗技术管理规范（征求意见稿）为规范自体免疫细胞（T细胞、NK细胞）治疗技术临床应用，保证医疗质量和医疗安全，制定本规范。本规范为医疗机构及其医师开展自体免疫细胞（T细胞、NK细胞）治疗技术的最低要求。自体免疫细胞治疗技术是指从自体外周血中分离的单个核细胞经过体外激活和扩增后输入患者体内，直接杀伤肿瘤细胞或病毒感染细胞，或调节和增强机体的免疫功能。本管理规范适用于在临床上已完成安全性和有效性认证，并符合伦理要求，只涉及自体T细胞和NK细胞作为治疗手段的医疗技术。一、医疗机构基本要求（一）医疗机构开展自体免疫细胞（T细胞、NK细胞）治疗技术，应当与其功能、任务相适应。（二）三级甲等医院，具有卫生行政部门核准登记的与应用自体免疫细胞（T细胞、NK细胞）治疗技术有关的诊疗科目。（三）具有与自体免疫细胞（T细胞、NK细胞）治疗相关的科室，科室人员组成包括有与开展人体免疫细胞（T细胞、NK细胞）治疗技术相适应的执业医师、执业护士、具有免疫学专业背景的专家和自体免疫细胞（T细胞、NK细胞）制剂制备技术人员；具备开展自体免疫细胞（T细胞、NK细胞）治疗技术的场地、设备和设施；具备从事自体免疫细胞（T细胞、NK细胞）治疗质量控制的专业检验科室和人员。（四）医院设有管理规范、运作正常的由医学、法学、伦理学等方面专家组成的自体免疫细胞（T细胞、NK细胞）治疗技术临床应用与伦理委员会。（五）有至少2名具备自体免疫细胞（T细胞、NK细胞）治疗技术临床应用能力的本院在职医师，有经过自体免疫细胞（T细胞、NK细胞）治疗相关知识和技能培训的、与开展的自体免疫细胞（T细胞、NK细胞）治疗相适应的其他专业技术人员。二、人员基本要求（一）自体免疫细胞（T细胞、NK细胞）治疗医师1.取得医师执业证书，执业范围为开展本技术应用相关专业。2.有10年以上开展本技术临床应用相关专业临床诊疗经验，具有副主任医师及以上专业技术职务任职资格，在本医院连续工作不少于2年。3.经过卫生行政部门认可的自体免疫细胞（T细胞、NK细胞）治疗技术系统培训并考核合格。（二）自体免疫细胞（T细胞、NK细胞）制备实验室人员1.制备自体免疫细胞（T细胞、NK细胞）实验室至少有1名副高级及以上专业技术职务任职资格的总体负责人，从事细胞制备的操作人员应具有相关专业（生物、免疫、检验和医学）大学（专）本科及以上学历，有不少于50例实验性免疫细胞制备经验，经专业技术培训并考试合格。2.从事质量检验的工作人员应具有相关专业大学（专）本科及以上学历，经专业技术培训并考试合格。（三）其他相关卫生专业技术人员经过自体免疫细胞（T细胞、NK细胞）治疗相关专业系统培训并考核合格。三、技术管理基本要求（一）细胞质量控制要求1.提供自体免疫细胞（T细胞、NK细胞）制剂制备的实验室应具备省级以上药品监督管理部门和疾病预防控制中心认证的GMP制备室，有细胞采集、加工、检定、保存和临床应用全过程标准操作程序（SOP）和完整的质量管理记录。制定并遵循cGMP实验室维护标准操作程序（SOP）。2.自体免疫细胞（T细胞、NK细胞）制剂制备要求：体外操作过程的细胞培养成分和添加物（培养液、细胞因子、血清等）以及制备过程所用的耗材，其来源和质量认证，应符合临床使用的质量要求，原则上鼓励采用无血清培养基、自体血清或者自体血浆。不允许使用异种血清或者血浆。3.自体免疫细胞（T细胞、NK细胞）制剂制备质控标准：（1）细胞制品外源因子的检测包括：细菌、真菌、支原体和内毒素。参照现行版中国药典生物制品相关规程进行。（2）细胞质量指标：每批细胞应注明来源并加以标记或确定批号；细胞数量应满足临床最低需求，存活率应不低于80%；纯度和均一性已达到临床应用水平；体外检测细胞具备正常功能和生物学效应，如细胞具有的某种生物学功能，分泌某种产物的能力，表达某种标志的水平等。无菌试验：每批培养的细胞在患者输注前均应进行无菌试验。建议在培养开始后34天起每间隔一定时间取培养液样品，包括患者回输前48小时取样，按现行版中国药典生物制品无菌试验规程进行。在患者使用前，取培养液及/或沉淀物用丫啶橙染色或革兰染色，追加一次污染检测。进行长期培养的细胞，应进行支原体检查。对每一批细胞终制剂应留样检测。如果留样发现阳性结果或发现几次阳性结果后，应及时对生产过程进行检查。如果在细胞制备的早期发现有污染的情况，应终止该批细胞制品的继续制备。4.细胞制备实验室应具有自体免疫细胞（T细胞、NK细胞）制备及检定过程的原始记录和检定报告，并永久保存。（二）自体免疫细胞（T细胞、NK细胞）治疗技术临床应用伦理要求原则为：科学性原则、不伤害原则、知情同意原则、对病人有利原则、尊重原则。治疗前患者及家属应享有充分的知情权，应当向患者和家属告知治疗目的、治疗风险、治疗后注意事项、可能发生的并发症及预防措施等，并签署知情同意书。（三）严格遵守自体免疫细胞（T细胞、NK细胞）治疗技术操作规范和诊疗指南，根据患者病情、可选择的治疗方案、患者经济承受能力等因素综合判断治疗措施，因病施治，合理治疗，严格掌握自体免疫细胞（T细胞、NK细胞）治疗技术临床应用适应证和禁忌证。（四）自体免疫细胞（T细胞、NK细胞）治疗由2名以上具有自体免疫细胞（T细胞、NK细胞）治疗技术临床应用能力的、具有副主任医师以上专业技术职务任职资格的本院在职医师提出，经本院自体免疫细胞（T细胞、NK细胞）治疗技术临床应用与伦理委员会审核通过后实施，并制定合理的治疗与管理方案。（五）自体免疫细胞（T细胞、NK细胞）治疗医师应当在治疗手术结束后的48小时内书面向本单位自体免疫细胞（T细胞、NK细胞）治疗技术临床应用与伦理委员会报告病例相关情况。（六）自体免疫细胞（T细胞、NK细胞）产品必须有cGMP细胞实验室负责人完成质量控制检测并签字后方能用于治疗。医疗机构应建立完整的自体免疫细胞（T细胞、NK细胞）治疗技术临床应用不良反应（事件）处理预案和紧急上报程序，并严格遵照执行。（七）建立并配备专职人员严格管理自体免疫细胞（T细胞、NK细胞）治疗技术临床应用数据库，完善病人的长期跟踪、随访制度，并按规定进行随访、记录。建立细胞样本存档的标准操作程序，样本和文本数据保存期限为30年。（八）医疗机构和医师按照规定定期接受自体免疫细胞（T细胞、NK细胞）治疗技术临床应用能力评估，包括病例选择、手术成功率、严重并发症，死亡病例，医疗事故发生情况，治疗后病人管理，病人生存质量，随访情况和病历质量等。按规定及时向卫生行政部门上报本技术临床应用情况，上交备份数据及标本。（九）其他管理要求1分离、纯化细胞产品所需试剂和器械均必须经食品药品监督管理部门审批，具有临床应用的许可证。一次性耗材不能重复使用。使用经药品监督管理部门审批的医用物品和耗材，建立登记制度，保证来源可追溯。2严格执行国家物价、财务政策，按照规定收费。避雷带的敷设面为曲面或带有造型面时，应反复多次的比试，避雷带应顺其造型敷设，圆钢避雷带圆钢之间的搭接处的位置应设置均布、合理、美观，且应尽量的减少搭接，搭接处如与引下线焊接处接近应设置焊接到一起，避雷带焊接时应顺直的放置到支架上，各段应受力均匀，不得有翘曲、扭转，promoted development, and The ability to resolve conflicts and constantly improve, our . 6. on the building of Socialist culture in China. A country, a nation strong, always supported by culture flourished, the inheritance and development of civilization, without culture to develop and prosper, there will be no realization of the dream of China. 18 big yilai, XI General Secretary around foster and promote Socialist core values promote China excellent traditional culture firmly master ideology work led right and discourse right, aspects do has series important speech, main including put publicity thought work do have better for achieved China dream condensed powerful moral support improve national culture soft strength foster and promote Socialist core values youth to consciously practice line Socialist core values Childhood actively cultivate and practice the core values of socialism and the partys important speech on the press conference. 7. promote the reform and development of social undertakings and social management. 18 big yilai, Central insisted put guarantees and improved livelihood as ruling acting political of starting point and foothold, Xia big pneumatic solution masses most care most directly most reality of interests problem, 3 years cumulative reduction poverty more than 50 million people, equivalent to a medium national population of total, annual added town employment more than 10 million people, starts construction supportability housing engineering near 4 million sets, built world Shang scale maximum, and cover universal of basic medical guarantees network and pension guarantees network, urban and rural residents income continued growth, The lives of the people of all ethnic groups have more on both material and spiritual thriving. This aspects XI General Secretary of speech main including promoted poverty area poverty, and speed up development let 1.3 billion people enjoys better more fair of education speed up advance housing guarantees and supply system construction always put people life security put in first bit efforts put China construction became network power insisted general national security views, go China features national security