【作者】 于海涛；

【导师】 孙全富；

【作者基本信息】 中国疾病预防控制中心 ， 公共卫生， 2009， 硕士

【摘要】 个人剂量监测工作在放射工作人员职业健康管理中居于中心地位。国际原子能机构等国际组织高度重视,先后出版了大量的的标准、导则和相关文件。个人剂量记录的产生和保持是个人监测不可或缺的部分。国际上一些发达国家或地区,如欧盟、加拿大、日本、韩国等从上世纪七十年代中后期开始,随着计算机和互联网技术的发展,逐步建立了比较完善的基于计算机和互联网的个人监测管理登记系统,系统持续有效的运行为放射防护监管部门评价本国放射工作人员职业照射水平提供了重要基础数据,在改善职业放射防护工作中发挥着越来越大的作用,为评价小剂量电离辐射照射的健康效应流行病学研究提供了重要资料。我国个人监测工作起步于上世纪五十年代。从1985年起开始,我国正式在全国范围内实施放射工作人员个人剂量监测制度,到九十年代末,我国个人监测工作在全国31个省、自治区、直辖市均得到开展。到二十世纪90年代初,我国逐渐完善了包括个人监测数据在内的逐级纸质汇总上报的放射卫生工作统计报告制度。但一直没有建立严格意义上的登记制度,没有统一的国家级剂量记录与信息数据库。2004年IAEA专家团评估认为我国放射工作人员个人监测登记报告系统亟需改进甚至重构。本课题目的在总结以往个人监测系统开发的经验基础上,平衡卫生行政部门放射工作人员职业健康管理工作和个人监测机构的不同需求,构建一个基于计算机及互联网的、以个例为单位的、满足国家相关法律法规和标准规范要求的、与国家新统计报告制度衔接的国家级个人监测信息管理系统,且能够产生UNSCEAR, IAEA等国际组织要求的统计报表。通过整合全国个人监测数据信息,建立统一有效的个人监测中央数据库,统一数据记录格式及信息采集格式。通过对数据的综合统计、分析,为管理决策提供科学依据,并可为放射防护、流行病学等研究提供基础数据。系统开发前期,中国疾控中心辐射安全所对全国8个省市进行了典型调查,多次到工作量较大的个人监测机构进行现场调查,参与开发了中国疾控中心《健康危害因素监测信息系统》中的“放射卫生专业”系统,并对国外有关个人监测登记系统进行了系统调研。在系统需求分析阶段,对德国、加拿大、日本等主要发达国家的国家个人监测登记系统进行了详细的分析,对全国个人监测机构的现状以及既往一些机构开发的个人剂量管理系统的情况进行了系统性分析。需求分析和建模阶段,分析我国个人监测工作4类传递流程,明晰了系统中可能涉及到的5类用户,对用户的业务需求进行了详细的分析。通过引入信息化成熟度分析,评估全国个人监测的信息化水平,明确系统的总体任务和建设目标,从而有计划、有重点的进行开发和完善。在确定系统的体系结构阶段,注重系统实用性并力求满足国内及国际组织的有关标准规范的要求,注意平衡基于Web模式软件与脱机版软件的优缺点,最终确立了脱机版+B／S(网络版)混合式+数据定制上传模块的系统体系结构。系统建模阶段,依据IAEA的建议,综合欧洲七国国家报告中管理系统的内容以及《国家卫生统计调查制度》的有关要求,考虑到我国个人监测工作的实际情况和系统将来的扩展,将系统信息分为8大类11个部分,构建了系统的实体联系模型(ERD)和数据业务处理模型,定义8张数据库表、16部字典,确立了数据库所含字段,设计了系统脱机版和网络版的功能及详细的视图。对于人员识别、系统采用剂量量和职业分类字典的细化调整等关键问题进行了研究。考虑到目前国内现行有效的个人监测规范,系统仍采用Hp(10)、Hp(0.07)、Hp(3)三个实用量；依据有关法规和实际调研情况,调整和细化了职业类别；研究设立了系统指标,引入了与监测周期相关的调查水平,确定了监测周期调查水平的算法；构建了针对三种个人监测数据录入方式的Hp(10)算法；建立了跨年度周期的年剂量算法；确定了以剂量分布区间和人均年有效剂量E、集体剂量S、集体剂量分布比SRE、个人剂量分布比NRE等指标作为系统的主要统计指标,并建立了相关算法；设计了符合计量认证要求的周期报告和年报告以及大剂量核查登记表；系统可以提供符合国家和国际要求的各类统计报告表,可以以各种趋势图直观反映集体剂量、人均剂量、个例放射工作人员周期剂量变化的趋势。系统特别注意了数据传输和用户访问的安全问题。设计自动提醒备份功能和数据库恢复功能,提出了系统安全认证建设三种解决方案,对优缺点进行了比较与分析。系统采取的安全性控制措施主要包括对用户的授权和权限的限制、数据加密传输、用户身份验证、数据库备份和恢复策略。在完成需求分析、建模和实现设计之后,通过委托工作方式,完成了系统的开发。利用事先编制的、从个人监测真实数据提炼出的测试数据及方案对系统进行了测试,并于2008年4月修改完成了β版。之后组织了全国6家监测机构对β版进行试用测试,并根据测试结果,对系统的功能和视图等做了修改。试用中各机构一致反映系统切合监测机构实际需要,操作方便,产出表规范,提高了工作效率。2009年4月1日,通过了由卫生部食品安全综合协调与卫生监督局组织的项目鉴定,专家建议尽快在全国个人剂量监测机构中组织推广。更多还原

【Abstract】 The use of ionizing radiation and radioisotope is widespread since the 20th century. However, the risks associated with radiation exposure has been recognized since early studies on high level of radiation and long term epidemiological studies of populations exposed to radiation.As the essential part of the occupational protection due to external radiation sources, In recent years there has been a tremendous increase in the development and publication of standards, documents of relevance and other guidance for individual monitoring (IM) issuing by extensive list of international units, such as the International Commission on Radiological Protection (ICRP), International Commission on Radiation Units and Measurements (ICRU), International Atomic Energy Agency (IAEA) etc. Dose records keeping is necessary part of the IM process and should be uniquely linked to the individual worker for the purpose of confirmation of good working practice and estimation of the actual exposure of workers. Dose records may be used for a number of others purposes, such as provision of information about exposure trends, development of operating procedures and providing basis data to epidemiological studies of the exposed population.For these purpose, many countries have established their own national dose registry system respectively which is based on the PC and Web technicology and provides extreme valuable information on occupational exposure protection for the authority.China started the IM on radiation exposured workers since 1950s and addressed the national regulations of IM on 1985. By the early 90s, China has developed the statistics collecting regulations on radiation protection information including IM’s. However, China’s national dose registry system should be modified and rearranged and a national dose data base needs to be set up according to the assessment report by the experts in IAEA on 2004.The study aims at the construction of a national IM for occupational external exposure registry system laying down the relevant national legislations, regulations, standards and the national statistics system. The requirements of IAEA and the modern electronic technique should be taken into account carefully during the process. Also the situation of local individual monitoring services should be concerned. The main tasks of the registry system are centralized and safe keeping of individual dose records, improvement of the surveillance and the control of exposed workers, statistical analysis of dose development and dose distribution and support of epidemiological studies.Before the establishment of the system, the NIRP has set up surveys on occupational radiation exposure within 8 provinces and investigations of situation on several large IM services. Furthermore, the NIRP participated in the Health Hazards Surveillance System in China CDC and operated the Radiation Health System. From 2005, NIRP sent staff successively to several countries to accept training and operate science visiting. Subsequently, NIRP associated with Jiangsu CDC to establish the local registry system successfully on the basis of their former experience.The first part of the study, the reliable information on the international IM including current registration systems in each country is collected and the data of some domestic IM management systems is given.During the needs analyzes and modeling stage,4 process in IM was classified and 5 specific type users were validated. Moreover, the need for each user was qualified. For the purpose of confirming the general task and strategy of the system, IMM (informatization maturity model) was introduced to assess the IM information level in China to ensure the process going smoothly and efficiently.A set of basic strategy were used to develop the system architecture such as practicability, complying with the international requirements, on the basis of Web, the integrality and reliability of data. A mixed system architecture which comprised an offline local edition, online B/S edition and a customized data package was determined. The two edition provide different function to the users in order to balance the advantages and disadvantages between offline and online.The content of the data base was classified 8 classification information and 11 specific components. With the defining of 8 data forms and 16 dictionaries, the ERD and the data process module were constructed. Both of The views on offline local edition and online edition were designed respectively and the annual data quantities were assessed. The Dose quantities used in the system were Hp(10)、Hp(0.07)、Hp(3). The Occupation Category was arranged more specific for the purpose of practicability and clarity to meet the current condition of IM services in China. The system index and its relevant mathematics model were constructed. The system record level was determined and investigation level was inducted corresponding to the relevant monitoring interval. According to the 3 different data input mode on the offline local edition, the monitoring interval and calendar year were adopted to construct the mathematics model of annual dose.The system adopted the annual average effective dose E, collective dose S, the collective dose distribution ratio SR and the number of workers distribution ratio NR as the main statistics index, designed the dose distribution range. A standardization format of monitoring results reports were designed to comply with the requirements of the IM services needs. An investigation form due to unexpected dose or high dose was also designed for the IM services and other documents, such as, statistics forms and dose trends diagrams were designed for the IM services to promote practical convenience for their routine work..The security of the system should be taken into account since it is a national data base. The accreditation of users was designated for each type user to limit their access rights to access the database. The certification accreditation of system constructed, the backup and resume were the essential part as the classic database security approach.As the need analyzes and modeling process finished, in February 2008, a contract was signed with a software company to develop the system according to the need analyzes and the modeling designation. As soon as the beta edition was finished on April 2008, a testing program was organized immediately among the IM services from 6 provinces and regions in China by NIRP. It was proved that the system was of high quality and flexible appearance after the testing program ending. On April 2009, the Food Safety Administration and Health Inspection Bureau of MOH set up a verification committee to validate the system and suggested to spread the system to the whole country.Innovation:The system is the first centralized dose data base in China. The frame work of the system was in accordance with the national regulations and standards, national health statistics system and the requirements of the international units. By adopting appropriate dose quantities and record format, the system harmonized dose results reports, the investigation forms and the information collection. Considering its performance and the wide spread vision in the future, the system will continue to improve and strengthen the radiation protection management in China.更多还原