[member column] series of reports on medical laboratory construction (three)

点击上方“CAIVD”关注我们一实验室生物安全考量
Click on the CAIVD to focus on our laboratory biosafety considerations
检验科除了有大量的电气设备、易燃易爆、剧毒危险品外,每天接受各种有潜在传染危险的标本,可能涉及甲、乙、丙、丁、戊型肝炎、艾滋病、麻疹、风疹、流行性乙型脑炎、流行性脑脊髓膜炎、菌痢、梅毒、疟疾、伤寒和副伤寒、霍乱等传染性疾病,这就要求检验科应把安全性放在首位。
In addition to Laboratory Department of electrical equipment, a large number of highly toxic, flammable and explosive dangerous goods every day, accept all kinds of potentially infectious specimens may involve a, B, C, D, E hepatitis, AIDS, measles, rubella and epidemic encephalitis B, epidemic cerebrospinal meningitis, malaria, dysentery, syphilis, typhoid and paratyphoid fever, cholera and other infectious diseases, which requires the laboratory should put safety in the first place.
为了保证安全性,设计时要严格按相关的行业标准及法律法规来装配布局,特别是工作流程、工作区域的分布是否合理将直接影响实验室的安全性。安全通道、消防设施、水电网管、防鼠防蚊、生物安全柜、通风口,排风口、给排水、自动感应设备、消毒感控设备的布局都应详细论证、确保合格。
In order to ensure the safety, the design should be strictly in accordance with the relevant industry standards and laws and regulations to assemble the layout, especially the work flow, the distribution of the work area is reasonable will directly affect the safety of the laboratory. Safe passage, fire facilities, hydropower management and prevention of mouse anti mosquito, biological safety cabinet, vents, exhaust, drainage, automatic equipment, disinfection equipment layout should have a sense of control in detail, to ensure that qualified.

企安殿助力高校开启网络空间安全学科建设新模式

法规篇
Regulations article
(1)卫生部《医务人员艾滋病病毒职业暴露防护工作指导原则》(2004.6.1)
(1) the guiding principles for the occupational exposure protection of medical staff in the Ministry of Health (2004.6.1)
(2)建设部GB 503462004《生物安全实验室建筑技术规范》(2004.9.1)国家标准
(2) the Ministry of construction, GB, the national standard for building technology standards for biosafety laboratories (2004.9.1) ()
(3)国家质量监督检验检疫总局和国家标准化管理委员会GB19489-2008《实验室生物安全通用要求》(2008)强制性国家标准
(3) the State Administration of quality supervision, inspection and quarantine and the National Standardization Management Committee GB19489-2008 General requirements for laboratory biosafety (2008) mandatory national standards
安全活动周企业安全负责人员畅谈办公室及网络信息安全基础
(4)国务院424号令《病原微生物实验室生物安全管理条例》(2004.11.12)
(4) the State Council Decree No. 424 of pathogenic microbiology laboratory bio safety regulations (2004.11.12)
(5)《中华人民共和国传染病防护法》(修订版)(2004.12.1)
(5) the law on the prevention of infectious diseases in People’s Republic of China (Revised Edition) (2004.12.1)
(6)卫生部45号令《可感染人类的高致病性病原微生物菌(毒)种或样本运输管理规定》(2005.5.20)
The Ministry of Health (6) No. 45 human infected highly pathogenic bacteria (virus) or sample transport management regulations (2005.5.20)
(7)《人间传染的病原微生物分类名录》(2006.1.10)
(7) directory of pathogenic microorganisms for human infection (2006.1.10)
(8)卫生部50号令《人间传染的高致病性病原微生物实验室和实验活动生物安全审批管理办法》
The Ministry of Health (8) No. 50 human infection of highly pathogenic microorganism lab and biosafety safety approval procedures

(9)农业部52号令《高致病性动物病原微生物实验室生物安全管理审批办法》(2005.5.20)
The Ministry of agriculture (9) No. 52 highly pathogenic animal pathogenic microorganisms laboratory bio safety management measures for the examination and approval of (2005.5.20)

黔江区开展新招录职工安全知识培训上岗

(10)国家环境保护总局32号令《病原微生物实验室生物安全环境管理办法》(2006.5.1) (11) 常用化学危险品贮存通则(GB 15603-1995)(12)国务院445号令:《易制毒化学品管理条例》(2005.11.1)(13)中国合格评定国家认可委员会CNAS-RL05《生物安全认可准则》(2008.8.1)(14) 中华人民共和国卫生行业标准WS/T 249-2005《临床实验室废物处理原则》二医学实验室质量管理体系的合理建立
(10) the State Environmental Protection Administration Decree No. 32 microbiological laboratory bio safety environmental management measures (2006.5.1) (11) the use of chemical dangerous goods storage general (GB 15603-1995) (12) of the State Council Decree No. 445: precursor chemicals management regulations (2005.11.1) (13) China National Accreditation CNAS-RL05 biological safety accreditation standards (2008.8.1) (14) to establish a reasonable quality management system of People’s Republic of China health industry standard WS\/T 249-2005 clinical laboratory waste treatment of the principle of two medical laboratory
如何建立一套科学、标准、规范化的质量管理体系,让其能正常运行并持续改进,是每一位医学实验室管理工作者非常重视也非常困惑的问题。
How to establish a set of scientific, standard, standardized quality management system, so that it can be normal operation and continuous improvement, is a very important and very confused question of each medical laboratory management workers.
虽然目前有很多医学实验室也搭建了自己的质量管理体系,但大多是流于形式,在过程中出现了很多问题,诸如:实验室管理人员或工作人员对标准不熟悉,编写的文件与标准不相符,质量手册与程序文件脱节,过程中的风险点未形成文件加以控制,作业指导书未细化或未按厂商的要求进行编写,风险发生后未及时纠正并未给出持续改进措施等。那么,我们怎样来规避或杜绝这些问题的发生呢?
Although there are many medical laboratories also set up their own quality management system, but is a mere formality, there are a lot of problems in the process such as: the laboratory management personnel or staff are not familiar with the standard documents and standard compilation does not match between the quality manual and process documents, risks in the process of formation file control, operation instruction is not refined or not according to the manufacturer’s requirements for the preparation, the risk is not timely corrective measures did not give continuous improvement. So, how do we avoid or eliminate these problems?
大多专家建议采用PDCA循环法的原则来贯穿医学实验室的质量管理,其体系的建立大致可分为四个过程:P(lan):质量管理体系的策划与准备;D(o):质量管理体系文件的编写与运行;C(heck):质量管理体系的监督与检查;A(ction):质量管理体系的完善与改进。
Most experts recommend using quality management method of PDCA cycle principle throughout the medical laboratory, to establish its system can be divided into four processes: P (LAN): planning and preparation of the quality management system; D (o): the preparation and operation of the quality management system documentation; C (Heck): Supervision and inspection the quality management system; A (ction): with the improvement of the quality management system.
质量管理体系的策划与准备
Planning and preparation of quality management system
质量管理体系的策划与准备是成功建立质量体系的关键,主要工作包括:

芝罘区畜产品质量安全溯源行动开启

Quality management system planning and preparation is the key to the successful establishment of quality system, the main work includes:
1、医学实验室的全体成员学习质量管理体系的概念、方法、目的以及有关国际标准,使其能认识到建立先进质量管理体系的重要性。
1, all members of the medical laboratory to study the concept of quality management system, methods, objectives and related international standards, so that it can recognize the importance of the establishment of advanced quality management system.
2、明确医学实验室管理体系的质量方针和目标。医学实验室应制定出与自身特点相符合的质量方针,围绕质量方针确定质量目标,使质量管理规范化,质量活动程序化。
2, clear medical laboratory management system quality policy and objectives. Medical laboratory should develop a quality policy that is in line with its own characteristics, determine the quality objectives around the quality policy, standardize the quality management, and standardize the quality activities.
3、确定医学实验室的组织结构。医学实验室的组织结构应清晰,与外部、内部的隶属关系应明确,各岗位的职责、权限应制定合理,使科室全员能各司其职、相互配合、相互监督。
3, to determine the organizational structure of medical laboratory. The organizational structure of the medical laboratory should be clear, affiliation with external and internal should be clear, the post responsibility, should be established, so that the Department staff can carry out their duties, mutual coordination and mutual supervision.
质量管理体系的运行
The operation of quality management system
质量管理体系在运行过程中的各项活动可能发生偏离,为了保证质量管理体系的有效运行,需从以下几点加以重视:
The quality management system in the operation of the various activities may deviate, in order to ensure the effective operation of the quality management system, from the following points should be taken seriously:
1、文件培训。需制定翔实的培训计划,并按培训计划完成既定的培训内容。培训结束后应进行考核,对于考核不合格人员需重新进行培训及考核,直至满足管理要求。
1, document training. Need to develop a detailed training plan, and according to the training plan to complete the training content. Training should be carried out after the assessment, for the assessment of unqualified personnel need to re training and assessment, to meet the management requirements.
2、文件管理。质量管理体系的文件管理需制定明确的、文件化的管理程序,以对所有质量管理体系文件和信息进行控制。主要包括:文件编写、审核、批准;文件的使用管理;电子文件管理等。
2, document management. Quality management system document management needs to develop a clear, documented procedures for the management of all quality management system documents and information control. Mainly include: document preparation, review, approval, the use of documents management; electronic document management.
3、过程管理。它是医学实验室质量管理体系运行的难点。其内容主要包括:检验前过程、检验中过程以及检验后过程。检验前过程是决定检验结果”真实、准确“的前提,其涉及的人员除了检验人员外,还包括医护人员以及受检病人本身。任何一个环节的问题出现均可以导致检验结果的误差。检验中过程中需做好检验程序的选择、验证和确认,建立符合医学实验室自身的程序性文件,制定有效的质控规则并准确的加以判定,正确判断或评价检验结果的真实性,对未达到预期标准的环节能及时实施纠正措施并采取预防措施。检验后过程的质量管理就是指在完成样本检测后,能为临床及时提供真实、准确、无误的检验报告并能方便其查询的质量控制措施。当这一环节疏漏时,将使前期的过程(检验前、检验中过程)管理前功尽弃。
3, process management. It is the difficulty of the quality management system of medical laboratory. Its contents include: pre inspection process, inspection process and inspection process. Before the inspection process is to determine the results of the test, true, accurate, the premise of its personnel involved in addition to the inspectors, but also including the medical staff and the patients themselves. The problem of any link can lead to the error of the test result. Selection, verification and validation to make inspection procedures for inspection in the course of establishing procedural documents in accordance with the Medical Laboratory of its own, formulate quality control rules effectively and accurately determine the authenticity of judgment or evaluation of the test results, and to take preventive measures did not reach such expected standards of the implementation of corrective measures in a timely manner. The quality control of the inspection process is the quality control measures which can provide the real, accurate and correct inspection report for the clinic in time after the completion of the sample detection. When the omission of this link, will make the process (process inspection and test management) come to naught.
质量管理体系的监督与检查
Supervision and inspection of quality management system
为了保证质量管理体系的适宜性、充分性、有效性以及对患者医疗的支持,完善并改进质量管理体系在建设中的不足,医学实验室应制定内部审核计划,邀请外部机构进行评审,定期进行管理评审。内部审核或外部机构评审主要审核体系文件与认可准则的符合性、体系文件实施的有效性。通过内部审核及时发现体系建设、运行过程中的不符合或潜在不符合项,并进行及时、有效地整改,是质量管理体系得到进一步完善,满足实验室发展需求。
In order to ensure the quality management system suitability, adequacy and effectiveness of patient care and support, improve and improve the shortage of quality management system in the construction of the medical laboratory should establish internal audit plan, inviting external agencies for review, regular management review. Internal audit or external agency review of the main audit system documents and accreditation standards, the effectiveness of the implementation of the system documents. Through the internal audit in system construction, operation process of nonconformity or potential nonconformity, and timely and effectively rectification, quality management system has been further improved to meet the development needs of the laboratory.
质量管理体系文件的编写
Quality management system documentation
质量管理体系文件的编写是质量体系的一项重要工作。质量管理体系文件可分为:质量手册、质量体系程序、作业指导书(标准操作规程)、记录表格。
Quality management system documentation is an important work of quality system. Quality management system documents can be divided into: quality manual, quality system procedures, work instructions (standard operating procedures), record form.
1、质量手册是根据实验室的实际情况来写的纲领性文件,是质量管理体系文件架构中的核心部分,其内容主要描述质量管理体系、组织结构,明确质量方针和质量目标,确定各支持性程序以及质量管理体系中各岗位的作用和职责。
1, the quality manual is a programmatic document according to the actual conditions in the laboratory to write, is a core part of the quality management system documentation in the architecture, which mainly describe the quality management system, organizational structure, clear quality policy and quality objectives, roles and responsibilities of each position to determine the support program and the quality management system.
2、质量体系程序是质量手册中各要素的展开和具体表达,应具备较强的可操作性,其在体系文件中启承上启下的作用。
2, the quality system program is the elements of the quality manual deployment and specific expression, should have strong operability, the system file and a connecting role.
3、作业指导书(标准操作规程)是质量体系程序的支持性文件和细化,是医学实验室技术人员从事具体检验工作的指导。
3, work instructions (standard operating procedures) is the quality system procedures supporting documents and refinement, medical laboratory technicians engaged in the work of specific inspection guidance.
4、记录表格是记载过程状态和过程结果的文件,它是质量管理的重要基础,是信息管理的重要内容。
4, record form is a record of the process state and process results, it is an important basis for quality management, information management is an important part of.
质量管理体系的完善与改进
Improvement and improvement of quality management system
通过对质量管理体系进行监督、检查,及时发现医学实验室所存在的问题,以此作为下一周期质量管理体系实施的工作重点。对于体系中存在的不符合项应查明原因、评估纠正措施的需求、采取纠正措施并记录纠正措施结果,防止不符合发生。对于体系中潜在的不符合项应确定原因、评估预防措施的需求、采取预防措施并记录预防措施结果,防止不符合发生。实验室还应通过实施管理评审,持续改进质量管理体系的有效性。只有持续改进,才能确保实验室的质量管理体系良好运行。
对技术泄漏案件的调查和起诉会越来越多,防范离职员工带走商业技术机密是不可忽视的挑战,信息安全管理,需从技术、管理和员工的知识产权意识培训上入手。
Through the supervision and inspection of the quality management system, the problems existing in the medical laboratory are found in time, which is the key point of the implementation of the next cycle of quality management system. To identify the cause of the nonconformity in the system, to assess the need for corrective actions, to take corrective actions and to record the results of corrective actions to prevent non conformance. For potential nonconformity in the system, determine the cause, evaluate the needs of preventive measures, take preventive measures, and record the results of preventive measures to prevent the occurrence of nonconformity. The laboratory shall continually improve the effectiveness of the quality management system through the implementation of management reviews. Only continuous improvement, to ensure that the laboratory quality management system is running well.
综上,医学实验室若合理的对质量管理体系进行策划与设计,在质量管理体系的运行中,加以对文件的学习,过程的管理控制,定期的监督检查,风险的纠正预防。这样将会使质量管理体系长期处于一个持续改进、不断完善的状态,大大提高医学实验室的质量和能力。三三级综合医院评审与实验室认可
Therefore, if the reasonable of medical laboratory quality management system planning and design, in the operation of quality management system, to document the learning process management, control, supervision and inspection regularly, the risk of corrective and preventive. This will make the quality management system for a long time in a continuous improvement, continuous improvement of the state, greatly improving the quality and capacity of medical laboratories. 33 level general hospital accreditation and laboratory accreditation
近期,全省很多三甲医院即将迎来新一轮三级综合医院评审,根据《三级综合医院评审标准实施细则》,三甲医院检验科也将接受评审。而另一方面,越来越多的医院检验科也在申请由中国合格评定国家认可委员会(英文简称CNAS)组织的实验室认可,检验科主任可能会有一些困惑,三级综合医院评审与实验室认可有哪些相同点,而它们的差异又体现在什么地方。
Recently, many of the province’s top three hospitals will usher in a new round of three general hospital accreditation, according to the implementation of the general hospital accreditation standards for the implementation of the three, the third hospital laboratory will also be subject to review. On the other hand, more and more hospital laboratory in China application by the National Accreditation Committee (referred to as CNAS English) organization of the laboratory accreditation inspection department director, there may be some confusion, three grade comprehensive hospital accreditation and laboratory accreditation are the same, and the differences also reflected in what place.
一、三级综合医院评审2011年4月22日卫生部颁布《三级综合医院评审标准(2011年版)》(卫医管发〔2011〕33号),《评审标准》制定的政策依据为1994年9月1日颁布实施的《医疗机构管理条例》,其中第41条规定“国家实行医疗机构评审制度,由专家组成的评审委员会按照医疗机构评审办法和评审标准,对医疗机构的执业活动、医疗服务质量等进行综合评价。医疗机构评审办法和评审标准由国务院卫生行政部门制定”。
A grade three general hospital accreditation issued by the Ministry of health in April 22, 2011 three level general hospital accreditation standards (2011 Edition) (Wei Yi tube 2011 No. 33), the evaluation standard policy basis for the September 1, 1994 promulgation of the medical institutions management regulations, the provisions of article forty-first national accreditation system medical institutions, experts from the review committee in accordance with the measures for evaluation of medical institutions and evaluation criteria, comprehensive evaluation of medical practice, the medical service quality. The evaluation methods and evaluation standards of medical institutions shall be formulated by the administrative department of public health under the state council.
在评审标准制定中也借鉴了美国JCI、日本、台湾、香港等国家和地区医院评审评价经验。为了为增强评审标准的操作性,指导医院加强日常管理与持续质量改进,为各级卫生行政部门加强行业监管与评审工作提供依据,卫生部组织国内专家撰写了《三级综合医院评审标准实施细则》。细则共设置7章73节378条标准与监测指标。
In the evaluation standards, the United States JCI, Japan, Taiwan, Hongkong and other countries and regions of the hospital accreditation evaluation experience. In order to enhance the operability evaluation standards, strengthen the daily management and continuous quality improvement to guide the hospital, provide the basis for health administrative departments at all levels to strengthen the supervision and evaluation work, organization of the Ministry of health experts wrote the implementation of accreditation standards for grade three general hospital rules. Rules are set up in the 7 chapter of the 73 section of the 378 standards and monitoring indicators.
《实施细则》是针对整个医院的评审,覆盖医院全面管理及医疗服务全过程,其中第四章《医疗质量安全管理与持续改进》中第十六节《临床检验管理与持续改进》是针对医院检验科的评审,该节包括7个大条款29个小条款。
The implementation rules for the entire hospital review, covering the whole process of hospital comprehensive management and medical service, the fourth chapter improved medical quality safety management and continuous in section sixteenth clinical laboratory management and continuous improvement for the hospital review, this section includes 7 big 29 small clause clause.
从《评审标准》出台的历史背景可以看出,三级综合医院评审是由卫生行政主管部门主导,并组织专家对评审医疗机构的医疗服务能力进行的全方位评审,所有三级综合医院都必须接受评审,检验科作为医院的一部分接受评审。
From the evaluation criteria of Introduction to historical background can be seen, the review of grade three general hospital is dominated by the health administrative departments, comprehensive review and organize experts to review medical institutions, medical service ability, all three general hospitals must accept the assessment, inspection department as part of the hospital to accept the review.
三级综合医院评审是国家全面深化医药卫生体制改革,积极稳妥推进公立医院改革,逐步健全我国医院评审评价体系的一种举措,目的是促进医疗机构加强自身建设和管理,不断提高医疗质量,保证医疗安全,改善医疗服务,更好地履行社会职责和义务,提高医疗行业整体服务水平和服务能力。
Review of grade three comprehensive hospital is the national comprehensive deepening reform of the medical and health system, and actively and steadily push forward the reform of public hospitals, and gradually improve a measure evaluation evaluation system of our hospital, the purpose is to promote medical institutions to strengthen its construction and management, improve medical quality, ensure medical safety, improve medical services, to better fulfill their social responsibilities and duty, improve the medical service level and ability of whole industry.
二、实验室认可什么是实验室认可?认可是权威机构对一个组织有能力执行特定工作给出正式承认的过程。权威机构在我国是指中国合格评定国家认可委员会,它由中国认监委依法授权开展实验室认可工作。实验室认可是指认可机构按照相关国际标准或国家标准,对实验室实施评审,证实其满足相关标准要求,进一步证明其具有从事相关检验活动的技术能力和管理能力,并颁发认可证书。
Two, laboratory accreditation of laboratory accreditation? Accreditation is the process by which an organization gives formal recognition of the ability of an organization to perform a specific task. Authoritative institutions in China refers to the China National Accreditation Committee for conformity assessment, which is authorized by the China Accreditation Administration to carry out laboratory accreditation. Laboratory accreditation refers to authorized institutions in accordance with relevant international standards or national standards, the implementation of review of laboratory confirmed that meet the requirements of relevant standards, to further prove its related inspection activities engaged in technical and management ability, and issue a certificate of recognition.
认可所依据的标准为国际标准是由国际上权威专家起草,并经严格程序制定,是先进的技术要求和管理理念,医学实验室按照准则的要求建立质量管理体系,对于医学实验室技术评审所依据的标准为国际标准ISO15189《医学实验室质量和能力的专用要求》等同转化的国家标准CNAS-CL02《医学实验室质量和能力认可准则》(ISO 15189,IDT)及其在临床化学检验、临床血液学检验、临床体液学检验、临床免疫学定性检验、临床微生物学检验、分子诊断及实验室信息系统等8个文件。
According to the recognized standard for the international standard is drafted by international experts, and the strict procedures, technical requirements and advanced management concept, medical laboratory quality management system established in accordance with the guidelines of the requirements for medical laboratory technical review based on the international standard ISO15189 standard for medical laboratory quality and ability of the special the equivalent transformation of the national standard CNAS-CL02 medical laboratory quality and accreditation standards (ISO 15189, IDT) and in clinical chemistry, clinical hematology, clinical osology inspection, clinical immunology, clinical microbiology, qualitative test and molecular diagnostic laboratory information system 8 files.

组织信息安全管理人员应该了解互联网新型应用中的技术风险,如果业务也确实需要它们来推动,如果粗暴禁止使用,可能会导致他们找寻越过安全政策的翻墙方式,这反而让组织处于更危险的境界。

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