摘要
背景
自1895年11月伦琴发现X射线以来,电离辐射在各行各业中的应用日益广泛,随着医学科学技术和医疗卫生事业的不断发展,医疗行业已成为电离辐射技术应用最广泛的领域。X射线诊断、临床核医学、放射治疗及介入放射学等放射学科已成为现代医学的重要组成部分,为人类防病治病带来了巨大的利益。但风险与利益往往共存,医用辐射的潜在危害及防护也成为关注的重点。据联合国原子辐射效应科学委员会的报告,医疗照射是公众所受电离辐射照射的最大人工来源。如今,医用辐射防护问题因为涉及所有公众成员及其后代的健康安全而成为重要的公共卫生问题。
为加强医用辐射防护,保障从业人员及公众安全,国际国内制定了很多法规标准。但研究结果表明,依靠技术措施只能实现低层次的基本的安全目标,管理和组织措施可以实现较高层次的安全目标,但要从根本保障安全,最终要靠建设辐射安全文化。安全文化是“存在于单位和人员中的种种特性和态度的总和”、是“由一个组织的各层次,各群体中的每一个人所长期保持的,对职工安全和公众安全的价值及优先性的认识”。这清楚的表明,安全文化是独立于法律和制度之外确保辐射安全应用的一种观念或意识形态,它是无形的,但受很多具体因素的影响,又无时无刻不在有形的和具体的事物中表现出来。因此,如何对辐射安全文化进行合理、全面、科学的评价具有重要的意义。
本研究的立论包括以下方面:
(1)医疗现实的迫切要求。近年来,医用辐射技术应用广泛,越来越多的临床医师进入放射工作人员的行列,医院的辐射设备日益先进,很多医院的硬件设施已具赶超发达国家之势,但辐射安全的意识并没有得到相应的提高。伴随着放射诊疗手段的日益普及,医用辐射成为人群群体剂量升高的最大贡献,辐射安全特别是医疗照射安全问题迫切需要关注。
(2)辐射安全文化评价研究的缺乏。安全文化研究和评价在煤炭、航空、核能等领域多见,但针对医疗卫生事业和辐射安全管理领域的研究甚少。目前的现状是辐射安全文化评价体系、评价指标和评价标准的基础研究均缺乏。
(3)政策及管理措施的补充。目前,我国辐射安全管理体系已有其模式,在辐射设备的合理配置、放射诊疗许可准入、职业照射危害控制等方面也颇具成效。但在辐射安全意识的建立、职业道德素质的培育、医疗照射危害的控制等方面呈无力之态。加强辐射安全文化建设是卫生政策体制完善的有益补充,也是卫生事业健康长远发展的根本保障。
研究目的
在辐射安全文化理论研究的基础上,通过剖析辐射安全文化的影响因素,结合医疗机构辐射安全文化现状调查,构建一套切合实际的、具有较高信度和效度的医疗机构辐射安全文化评价指标体系,同时探索建立评价指标、评价标准及评分原则的研究方法,并用研究所得的评价体系和评价方法对各级医疗机构的辐射安全文化和辐射安全管理水平进行实证研究,对其辐射安全管理工作中较为满意和需要改进的方面进行识别,提出相应的建议。此项研究对于我国放射诊疗服务和医疗卫生服务事业的持续健康发展具有重要的意义,同时可为相关政策的制定提供坚实的理论和方法学的基础。
研究方法
本研究通过广泛查阅文献,参考国内外相关研究成果,运用辐射安全文化理论、人因失误理论、综合评价理论等方法,经过“评价体系总体框架构建——指标初步拟定——指标论证与确立——指标权重确定——综合评价初步实践”的步骤,构建了辐射安全文化评价的研究思路,并依据该思路确立了辐射安全文化评价指标和综合评价模型。
研究中采用文献复习法、抽样调查法用于资料的收集和总体思路的建立;利用专家论证法和预实验的方法探讨评价指标的完善和建立;采用专家咨询法确定各级指标的权重方案,并进行组合权重系数的计算;采用相关与回归分析、因子分析法、克朗巴赫α系数计算等数理统计方法进行安全文化影响因素的分析和指标体系的信度、效度计算;最后采用方差分析、信度、效度检验的方法对综合评价模型的实证结果进行分析和验证。
研究结果
通过上述研究活动,本研究取得了如下研究结果:
(1)在理论分析的基础上对可能影响辐射安全文化系统的因素进行归纳和剖析。研究共包括14个影响因素,其中内部影响因素有:安全意识(管理者安全意识、员工安全意识)、安全需要、组织承诺、管理参与、激励约束、员工授权、沟通报告、教育培训、安全作业环境;外部影响因素有社会安全价值观、社会安全需要、经济文化和生产力发展水平、国家法规标准。经回归分析得知员工授权和经济文化和生产力发展水平因素与辐射安全文化系统的相关系数分别为0.42和0.49,其余各影响因素的相关系数均在0.50以上。本研究选取的14个变量对辐射安全文化系统的解释力为92.9%。可以较好的对辐射安全文化系统进行概括和分析。
(2)调查了山东省医疗机构辐射安全文化建设现状,结果显示不同等级医院的辐射安全文化水平有显著性差异。在辐射安全文化知晓情况、安全管理体制建设、安全防护人员配备、领导公开承诺安全职责、安全责任分工、人员资格审查和培训、科室安全防护设备配备等方面三级医院均好于二级和其他等级医院;不同等级医院在健康查体、辐射事故后的改进方面差异不明显;调查发现,个人防护用具,特别是患者防护用品的使用率很低、患者就医时的辐射剂量和辐射危害基本不被关注,这在被调查的各级医院和不同的医务人员间未见明显差异。
(3)基于安全文化及相关理论,提出了针对医院决策层、科室管理层、员工执行层三个评价主体,结合内、外工作环境层作为一级评价指标的医疗机构辐射安全文化评价体系的总体框架;根据辐射安全文化影响因素和现状的调查研究,拟定了具体的二、三级评价指标和相关的评价标准;通过专家多轮次的论证和预实验的方法对评价指标讨论稿进行增减、修订和完善,确定了由包括4个一级指标、14个二级指标和92个三级指标组成的综合评价模型;采用专家咨询法(德尔菲法)进一步对确立的指标体系进行权重分配,并在专家咨询的基础上计算出各级指标的组合权重系数。
(4)为明确辐射安全文化综合评价模型的有效性和实践操作性,对山东省26家医院进行了调查研究,分别就各级医院的总体得分情况、不同等级医院辐射安全文化水平、不同评价主体间辐射安全文化水平等方面进行分析评价。其中得分在55分以下的医院占被调查医院总数的11.54%,说明这些医院尚处于辐射安全文化发展的低级阶段;有13家医院得分在55-75分之间,处于辐射安全文化发展的初级阶段;有34.62%的医院得分在75~95之间,处于辐射安全文化发展的中级阶段;得分大于95分的仅有一家,占被调查医院总数的3.85%。
(5)信度与效度考核:研究中分别对影响因素问卷调查和综合评价模型的实证研究进行了信度与效度统计学检验:(1)内部一致性信度较好,各影响因素变量或评价指标的克朗巴赫a系数达到“较好(0.6-0.8)”或“极好(0.8以上)”以上认定标准;(2)评价指标体系从总体构想、指标的确定、评价标准的建立及指标权重的赋值,均采用了理论借鉴、多轮次专家论证及专家咨询法,并得到专家的认可,保证了该评估指标体系良好的内容效度;(3)结构效度较好,探索性因子分析所提取公因子均可获得较好的专业解释。(4)该评价指标体系能有效区分不同等级医院、不同评价人群,检验结果提示区分效度好。证明评价指标体系合理和可行。
结论和建议
基于上述研究结果,本研究得出了以下几点结论:(1)研究中建立的综合评价指标体系合理、全面、有效:(2)评价指标确定和评价体系构建的研究方法是合理可行的;(3)确定指标权重系数的方法和结果是科学和准确的。(4)综合评价模型在实际应用中经证实是可靠的和有效的。
鉴于我国医疗机构辐射安全文化建设水平普遍不高的现状,提出以下几点建议:(1)倡导观念建设,提高思想境界水平;(2)建立制度约束,规范规章制度举措;(3)加强监督管理,健全安全管理机制;(4)有效行为激励,培育健康医疗行为;(5)大力宣传教化,营造良好安全氛围。
创新与不足
本研究着眼于我国医疗机构辐射安全管理的特殊起点,主要对以下几方面的内容进行了有益探索和开创性的研究:
(1)目前对辐射安全文化研究较少,研究者将安全文化的研究理论与辐射技术医疗应用行业相结合,对辐射安全文化的内涵、特性及影响因素做了深入归纳和剖析,完善了辐射安全文化的理论研究。
(2)在山东省内较大范围抽样调查辐射安全文化认知情况、辐射安全管理情况,揭示了目前医疗机构放射诊疗服务与管理中存在的问题和辐射安全文化提升的必要性和途径。
(3)针对辐射安全文化评价体系和评价方法的缺失,结合医疗机构的行业特点,在文献综述、实地调研和专家咨询的基础上,确立了辐射安全文化综合评价的各级指标和指标的权重系数。该评价体系的建立填补了国内对辐射安全文化评价体系研究的空白,缩小了与其它行业的差距。
(4)利用专家咨询法和综合评分法构建医疗机构辐射安全文化综合评价模型经统计学检验具有良好的信度和效度,经实践验证切实可行。研究证明辐射安全文化综合评价模型可以作为医疗机构开展自我评价的有用工具,也可为行政主管部门制订相应政策和措施提供依据,为加强辐射安全管理提供借鉴和参考。
研究的不足:
(1)个别指标的设计还可进一步完善。辐射安全文化评价指标体系建立的最终目的是在实践中得到合理、科学的应用,得以对无形的辐射安全文化系统进行评估。但因为安全文化的特性,某些方面不易被准确度量,这在实证研究中有一定难度。如何全面、准确的反映这些指标,还需做大量的调查研究,有待进一步完善。
(2)进一步扩大实证研究的调研范围。针对不同类别、不同经济类型的医疗机构开展辐射安全文化评估,尽可能获得更多的数据,建立不同医院间的比较,为下一步提高辐射安全文化建设和水平提供数据基础和理论依据。
Background
The ionizing radiation was increasingly applied in various areas since X-rays was discovered by Roentgen in November1895. With advances in medical science and technology, the medical industry has become the area where the radiologic technology is most widely used. X-ray diagnosis, clinical nuclear medicine, radiation therapy and interventional radiology became the important components of the modern medicine, bringing great benefits to the prevention and curation of human disease. However, risks can come with benefits; the protection from potential damage caused by medical radiation has drawn attentions. According to a report by the United Nations Scientific Committee on the Effects of Atomic Radiation, the medical exposure is a public to ionizing radiation suffered the largest artificial origin. Today, medical radiation protection becomes an important problem of public health because it involves all members of the public and their descendants.
To strengthen the medical radiation protection and improve the safety of the working staff in this industry and the public, a lot of international and domestic regulations and standards were developed. But studies show that only low level of safety can be achieved through technological measures. While high level of safety can be achieved through management and organizational measures, it is the setup of safety culture that could bring about safety of fundamental level. Safety culture was "the sum of characteristics and attitudes which exists in the various units and personnel" and "a long-term awareness on the value and priority of security for workers and the general public of all levels of an organization, groups or individuals". It is clear that safety culture is a kind of Ideology or a concept independent of laws and regulations. It is intangible yet affected by many specific factors, and reflected from tangible and specific matters. So, it has great significance to evaluate the radiation safety culture rationally, comprehensively and scientifically.
The arguments of this study are as below:
First, it is an urgent requirement of medicine reality. Nowadays, medical radiation technology is widely used, more and more clinicians entered the ranks of radiation workers and more and more sophisticated equipments were used in the hospital almost to exceed the developed countries. But there has not been a corresponding increase in the awareness of radiation safety. With the increasing popularity of radiation treatment which means medical radiation dose increased as the greatest contribution of public ionizing radiation. It is especially urgent to focus on the issues of radiation safety, especially the medical exposure.
Second, there is a lack of researches in the area of radiation safety culture. The research and evaluation of safety culture are prevalent in the areas like coal, aviation, nuclear energy and other fields, but it is much less in the medical industry. There is now serious lack of basic research of evaluation system, evaluation indicators and evaluation criteria.
Thirdly, it is supplement of regulations and management rules. At present, China has its radiation safety management system model, which is effective on the rational allocation of radiation equipment, radiology permit access and occupational exposure hazard control. But it is not as satisfactory in terms of the development of radiation safety awareness and professional ethics, and the medical exposure hazard control. Enhancing radiation safety culture is a good complementary to the current health policy and a fundamental guarantee for healthy service development.
Objective
Based on the research of safety culture theory and the survey of medical radiation safety culture, to develop a comprehensive evaluation model and evaluation methods to assess the different levels of radiation safety culture in Chinese health institutes; meanwhile, to explore the research method to establish evaluation indicators, evaluation criteria and scoring methodology principles, and to conduct empirical survey of the safety culture and safety management in hospitals. This study has great significance on the development of Chinese medical and health industry and will provide a solid theoretical and methodological foundation for the health policies.
Methods
Based on the literature review, with the guidance of safety culture theory and the human error theory, this study developed research approaches on the comprehensive evaluation to radiation safety culture and established an indicator system and evaluation model of radiation safety culture according to the research approaches. The research steps of this study are:build the evaluation framework, establish initial indicators, define indicators, determine the weight of indicators, and empirical practice of the evaluation in hospitals.
Related literature and industrial research results had been extensively reviewed for the framework study and data collecting, discussion and suggestion from experts and pre-experiment had been considered for the indicators defining, and Delphi method had been adopted for the weights of indexes. Finally, the reliability and validity of the evaluation model were also tested.
Results
1. There was a deep analysis on different influencing factors based on the survey of130radiation workers in42hospitals in Shandong.14factors were considered, which are:safety awareness of medical staff, safety needs, organizational commitment, management participation, incentive systems, authorized employees, communication systems, education and training, safety working environment, social safety values, social safety needs, socio-economic and productivity levels of development, and the national safety laws and regulations. By employing multiple regression and factor analysis, the research draws the following conclusion:the14influencing factors can explanation92.9%of safety culture system of medical radiation. In general, radiation safety culture level is low.
2. A cross-sectional study of radiation safety culture and radiation safety management was investigated, and result shows the obvious difference between different levels of hospitals. Level3hospitals have better situation compared with level2or other hospitals on radiation safety culture awareness and responsibilities, safety management system, safety personnel, leadership commitment to safety duties, personnel qualification and training, and safety protection facility. In general, radiation safety culture level is low, most patients were not under attention of the medical worker during the radiation treatment and the safety protection facility is not used timely and properly.
3. On the ground of the human error theory, the author traces human errors back to their cultural root in the complex socio-technical system, and establishes the assessment system of radiation safety culture in medical institutes, in which3assessment main bodies:decision level of hospital, management level of department, and execution level of general staff were included. The evaluations of the main body are in the context of the working environments. This complete assessment index system consist4first-class indicators,14second-class indicators and92third-class indicators. Every indicator has its weight on the basis of experts' advices.
4. In order to define the effectiveness and operational practice of safety culture system in health institutes, the author conducts safety culture evaluation in26hospitals in Shandong. Through the comparison of overall level of radiation safety culture, evaluation decision level of hospital, management level of department, execution level of general staff and the working environment, the evaluation draws the following conclusions:most hospitals' score is among55to75, which means the safety culture grade is medium and needs improvement; the score of34.62%of hospitals is among75-95, which means their safety grade is relatively high and safety culture still has space to improve;3hospitals' score is below55, which is the lowest grade and safety culture needs much improvement; only1hospital's score is above95, and the radiation safety culture should be maintained.
5. Reliability and validity assessment:①Internal consistency is good, Cronbach's a coefficients of all indicators are higher than0.80or between0.60and0.80, some of them are even higher than0.9;②Content validity is good. The research has obtained various experts'suggestions and is recognized by professionals as well;③Construct validity is good, factor analysis is in line with logic relation, and the common factor extraction has good explanation of radiation safety culture system.
Conclusions and suggestions:
Based on the results of the research, following conclusions were reached. First, it can be certified that the assessment system is reliable, valid and comprehensive. Second, the methodology of the study of indicators and system is reasonable and feasible. Third, the weights of the indicators are scientific and accurate. Fourth, the evaluation model in the empirical research is reliable and effective.
In view of the lower level of radiation safety culture in China, the suggestions were given below. First, advocate concept building to increase ideological cognition. Secondly, establish the institutional control to regulate management activities. Thirdly, strengthen supervision and management to improve security system. Fourthly, set up incentives to encourage proper healthcare behavior. Fifthly, advertise to the public to create good atmosphere of safety.
Innovations and limitations:
The innovations of this research were as follows:
First, there are few studies on radiation safety culture currently. The researcher combine safety culture theory and the practice of the theory in medical institutions, to improve the radiation safety culture theory by deeply summarizing and analysing the connotation, characteristics and influencing factors of the safety culture theory.
Second, it is a large-scale sample survey of the cognition of the radiation safety culture. It reveals the problems in the current radiation protection and medical management and the necessity and ways to upgrade the safety culture level.
Third, this research establishes a comprehensive evaluation of radiation safety culture and allocates accurate weights for different indicators. The establishment of the evaluation system fills the gaps in this area and reduces the distance with other industries.
Fourth, it shows that the evaluation model has relatively good reliability and validity. It can be a good method to self-evaluate for the medical institutes and a good supplement to the administrative policies and measures.
Limitations:
First, several indexes can be improved. The ultimate goal of establishing the evaluation model is to put it into practice, but it is very difficult to measure the indiscernible of the safety culture. It needs a lot of research to make the evaluation system perfect.
Second, there are other methods being used in different areas and industries, it will be a great complement to to the system if these methods were used and comparative study be conducted.
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