江苏省血液净化技术管理规范(试行)

the principle of simplified EIA of construction projects in the region. In terms of land, linked to the implementation of urban and rural construction land increase and decrease, replacement indicators for priority areas project. Charges, into the projects of water, electricity, administrative charges and preferential policies. In the area of taxation, and settled in areas of industry and its production company, within 5 years after the completion of fiscal incentives to enterprises. In terms of financing, integration of land, tax, financial and other resources, and construct Government credit + business credit credit system, establishment of marketization, commercialization and modernization of the investment and financing platform; effective Bank-enterprise docking, encourages private capital into the Park, to raise industry development fund. 5, optimize the environment and service industries. To create policy lowlands, Highlands, integrity of service land, development land as the goal, to optimize the area under development environment. All administrative law enforcement departments to appoint a full-time personnel stationed in areas dedicated to coordinating and solving problems associated with businesses in this sector. When there are substantial issues, sector leaders arranged to personally intervene, in-person, in-person push tangible area building a green light, easy line. To further reduce and standardize administrative examination and approval items, simplify examination and approval links, improve efficiency; according to the .Since the educational practice of the mass line of the party, himself seriously in the education, practical control central eight rules and opposing the four winds and practicing three Suns, and check the spirit of Jiao Yulu, ideology, solicit opinions based on outstanding problems checked swing, careful analysis and reflection. Will now check report is as follows: first, adherence to the partys political discipline, eight in the central provision, change the style of the basic situation of 1, in compliance with the partys political disciplines. Conscientiously abide by the partys political discipline, abide by the Constitution and the rules and regulations of the party, in the political, ideological and maintain highly consistent with the CPC Central Committee on the action, there is no violation of the partys political discipline problems. 2, in the implementation of the central authorities of the eight provisions. Improving research, improving research methods, but there are less grass-roots units, primary first-hand an inadequate grasp of the problem, which is to be strengthened in the future. Second, construction, strictly in accordance with the provisions to streamline and improve the quality of meetings of the Conference. Third, streamlining file briefs, culture involves all aspects of propaganda and ideology, sometimes due to the practical needs of invention notifications, this area needs further附件1：江苏省血液净化技术管理规范（试行） 为规范血液净化技术的临床应用，保证医疗质量和医疗安全，特制定本规范。本规范为技术审核机构对医疗机构申请临床应用血液净化技术进行技术审核的依据，是医疗机构及其医师和护士开展血液净化技术的基本要求。本规范所称血液净化技术，指通过体外循环、借助各种净化装置清除体内代谢废物、血液中的毒素或毒物，排出体内多余的水分和纠正水、电解质、酸碱平衡的一系列治疗方法，以达到血液净化的目的。血液净化技术，包括血液透析、血液滤过、血液透析滤过、血浆置换、血液灌流、免疫吸附、连续性肾替代治疗、腹膜透析等技术。一、区域规划设置要求开展血液净化技术的医疗机构设置应根据医疗机构服务能力、人口分布等因素综合考虑、合理布局。原则上省辖市城区每20万人口可设立1所开展血液净化技术的医疗机构，县及县级市每30万人口可设立1所开展血液净化技术的医疗机构。新开展血液净化技术的医疗机构，原则上和原有开展血液净化技术医疗机构间的直线距离大于4公里。二、医疗机构基本要求（一）医疗机构开展血液净化技术应当与其功能、任务相适应。（二）二级以上医院，具有卫生行政部门核准登记的肾脏病专业诊疗科目，且核定床位10张，每年出院肾衰竭患者50例。（三）建筑布局要求1.血液透析室应当包括透析治疗区、水处理区、治疗室、候诊区、接诊区、办公区、污洗间、处置间、复用间和库房等基本功能区域。各功能区域应当合理布局，区分清洁区与污染区，清洁区包括透析治疗区、治疗室、水处理区和库房等，污染区主要包括污洗间、处置间和复用间。2.透析治疗区由若干透析单元组成。每个透析单元由一台透析机和一张透析床(椅)组成，每个透析单元面积不少于3.2平方米，床(椅)间距不小于0.8米。3.血液透析室应当设置5个以上透析单元。4.水处理区面积应为水处理机占地面积的1.5倍以上,地面承重应符合设备要求,水处理设备应避免日光直射。5.血液透析室应设置护士站，护士站应便于对患者实施观察及技术操作。6.乙型肝炎患者须设立在独立的透析间。丙型肝炎抗体阳性患者复用透析器的复用机须设立单独的复用间。（四）设备要求1.血液透析室应当配备符合规定的透析机、水处理装置、抢救基本设备、供氧装置、中心负压接口或可移动负压抽吸装置、双路供电系统、电子计算机网络设备和通风设备。2.血液透析室使用的医疗设备、医疗耗材、医疗用品等应当符合国家标准，并按照国家相关规定进行使用和管理。（五）具有较强的肾衰竭治疗工作基础和血液净化相关急、慢性并发症处理条件和能力，具备进行抢救治疗意外必要的急救设备和药品。三、人员基本要求（一）医护人员配置比例有至少2名医师和3名护士方能开展血液净化技术。医师与透析单元数之比为1:10，其中至少有1名主治医师；透析床位（透析机）数15张（台）时，至少有1名副主任医师。护士总数与透析机之比为1:2。当班护士与透析单元数之比为1:5-6。开展连续性肾替代治疗（CRRT）技术的，另配护士。（二）血液净化治疗医师1.取得医师执业证书，执业范围为内科专业；2.经过省卫生厅认定的医护人员血液净化技术培训基地培训，并考核合格。（三）血液净化治疗护士1.取得护士执业证书；2.经过省卫生厅认定的医护人员血液净化技术培训基地培训，并考核合格。（四）其他辅助人员医院应有专人负责血液透析室的设备保养和维修，10台以上透析机的血液透析室应配专职技师一名。四、技术管理基本要求1.建立规范合理的透析诊疗流程，严格遵守血液净化诊疗技术规范、操作规程和诊疗指南，严格掌握血液净化适应证和禁忌证。2.首次血液透析和接受新转来的患者，在开始透析前必须进行乙肝病毒标记物、丙肝抗体、HIV和梅毒抗体检测，阴性者每年至少复查一次。血液透析患者出现无法解释的丙氨酸转氨酶升高时，应立即进行乙肝DNA和丙肝RNA病毒检测。3.血液净化治疗前，应当向患者或家属告知治疗目的、方式选择、风险、可能发生的并发症及预防措施等，并签署知情同意书。4.建立健全血液净化治疗患者病历，并进行评估透析充分性、并发症防治相关检查和记录、随访等。透析病历包括首次病历、透析记录、病程记录、化验记录、用药记录等。5.严格遵守血液净化耗材使用规范，不得重复使用一次性血液净化耗材。6.建立工作人员管理制度、收费管理制度、安全管理制度、设备维修保养制度、感染管理制度和质量控制制度等管理制度。7.建立血液净化治疗的应急预案，如火警、停电、停水、透析器破膜、管理脱离、管道内血液凝管、透析机器故障、医院感染暴发等应急预案。8.定期上报血液净化相关资料。五、感染管理基本要求1.建立并严格执行消毒隔离制度、透析液及透析用水质量检测制度、相关诊疗技术规范和操作规程、设备运行记录与检修制度等制度。2.保持空气清新，光线充足，环境安静，符合医院感染控制的要求。 (1)清洁区应当每日进行有效通风，必要时进行动态空气消毒；(2)每次透析结束应更换床单、被套、枕套等，对透析间内所有的物品表面及地面进行消毒擦拭。3.当出现医院感染聚集性发生，应立即停止收治患者，查明原因，采取有效防范措施，避免造成严重后果。 4.根据设备的要求定期对水处理系统进行冲洗、消毒，定期进行水质检测，确保符合质量要求。每次消毒和冲洗后测定管路中消毒液残留量，确保在安全范围。5.建立透析液和透析用水质量监测制度。(1)透析用水每月进行1次细菌培养，在水路末端进入血液透析机的位置收集标本，细菌数不能超出200cfu/ml；(2)透析液每月进行1次细菌培养，在透析液透析器出口处或透析液进入透析器的位置用一次性注射器抽取标本，细菌数不能超过200cfu /ml；(3)透析液每三个月进行1次内毒素检测，留取标本方法同细菌培养，内毒素不能超过2eu/ml；(4)透析用水的化学污染物情况至少每年测定一次，软水硬度及游离氯检测至少每周进行1次，结果应当符合规定。6.每天透析结束后。应参照透析机制造厂商的推荐方法进行消毒，消毒有化学消毒、热消毒等。如透析中有破膜、漏血，应在每班治疗间对透析机内部进行化学消毒。7.经国家食品药品监督管理局批准的可以重复使用的血液透析器应当遵照卫生部血液透析器复用操作规范使用全自动复用机进行操作。8.医务人员应定期进行常见血源性感染病原学的检查。9.医疗废弃物管理应当按照医疗废物管理条例及有关规定进行登记、分类和处理。六、培训要求（一）拟从事血液净化技术的医师、护士应接受至少6个月以上的系统培训并考核合格。培训基地由省卫生厅指定，且具备下列条件：1.三级甲等综合医院，肾内科为市级以上重点专科。2.肾内科核定床位30张，透析单元30个，每年出院肾衰竭患者200例。3.有至少4名具有血液净化技术临床应用能力的指导医师，其中至少1名为主任医师。4.具备开展多种血液净化技术（包括血液透析、血液滤过、血液透析滤过、血液灌流、血浆置换、腹膜透析、连续性肾替代治疗等技术）临床应用的能力，有与开展血液净化技术培训工作相适应的人员、技术、设备和设施等条件。5.医院感染管理符合要求。培训基本要求：1.培训教材和培训大纲经省卫生厅认可。2.保证接受培训的医师和护士在规定时间内完成规定的培训。3.培训结束后，对接受培训的医师和护士进行考试、考核，并出具是否合格的结论。4.为每位接受培训的医师和护士建立培训及考试、考核档案。5.根据实际情况和培训能力决定培训医师和护士数量。（二）本规范实施前具备下列条件的医务人员，可以免于培训及考核开展血液净化技术：1.在三级医院连续从事血液净化诊疗临床工作3年以上，具有副高以上专业技术职务任职资格的医师；2. 在三级医院连续从事血液净化诊疗临床工作3年以上，具有中级以上专业技术职务任职资格的护士。（三）本规范实施前已从事血液净化诊疗、护理工作（免考人员除外）的其他人员，须经省卫生厅指定的培训基地进行短期培训并考核合格。发包人指定专人负责协调施工中的有关事宜，并监督施工进度、安全与文明施工。发包人对承包人施工中违规操作有权做好处理决定或经济处罚。streamlining. Four are standard visits, except as required to participate in training, no other activity. Five is to improve news reporting, for propaganda work strictly according to the regulations. Six is strictly your presentation published strictly according to the regulations. Seven is strictly thrift, required the use of vehicles and office space and corporate hospitality. 3, change the style. Propaganda and ideological work of the new situation and new requirements of the new tasks, had done a lot of fruitful work, has made many achievements, but further closer to the grass roots, close to reality, close to the masses and also inadequate innovation must continue to improve. Second, the four winds some outstanding issues 1, oppose formalism. One theory is that he didnt, with less close contact. Theoretical study of consciousness is not high enough, system performance is not strong enough; more passive learning, active learning few generalities and learn more, delving into less. Especially based on rational thinking on major issues, applying theory to guide the work done is not good enough, not really understand and grasp the spirit and essence of the scientific Outlook on development, did not truly achieve mastery, to apply, to a certain extent, affect the development and implementation of ideas and initiatives. Second, work arrangements, and less supervision. Propaganda and ideological work is the objective, which needs to keep the continuity efforts deployed, but stressed in the work time, less supervision. For example, color weekends in the summer theatrical activities, city square performances, urging townships, communities and rural areas shows the implementation is inadequate, insufficient cultural an educational role to play. Third base enough, master grass-less real. Propaganda and ideological work in the new situation of characteristics and regularity of enough, deep enough for grass-roots public opinion Dynamics survey, for grass-roots typically drive less. For example, rural culture team active, . Im not actively take the initiative to take up, the lack of spirit of daring to, resulting in some job had a lot of power, but no tangible