血站质量管理体系内部质量审核结果回顾性分析

Retrospective analysis of internal monitoring of quality management system of blood center

目的验证贵州省血液中心质量管理体系及其运行情况的符合性和有效性。方法通过回顾性分析2010-2013年内审发现的不合格项在各部门和各要素的分布情况,以及不合格项的性质和纠正措施完成情况,从而评价质量体系的运行情况。结果 2010-2013年内审发现的不合格项分别有42项、20项、18项和32项,不合格项的分布主要集中在供血科、体检采血科、检验科、质量管理科和后勤保障科等科室,主要涉及要素是组织和人员、设备、安全与卫生、记录和献血服务,一般不合格项107项(95.5%),严重不合格项5项(4.5%),不合格项的纠正预防措施基本得到落实。结论排除审核方式因素,不合格项逐年减少,说明贵州省血液中心的质量管理体系及其运行情况是符合和持续有效的。

Objective To assess the conformity and efficiency of the quality management system in Guizhou Province Blood Center. Methods The unqualified cases which were distributed in different branches, the factors for disqualification, their characteristics and corrective measures were analyzed retrospectively in order to assess the quality of the management system in blood center. Results As a result, 42, 20, 18 and 32 unqualified cases were found during 2010 to 2013, which distributed in Blood Distribution Department, Medical Blood Department, Clinical Laboratory, Quality Management Department, Logistics Department and other departments. The main factors included the deficiency or lack of organization, personnel staff, equipment, sgfety and health, recording and blood service. There were 107 average unqualified cases （95.5%） and 5 severe unqualified cases （4.5%）, indicating that the corrective measures were necessary. Conclusion Not taken into consideration of the factors in assessing approaches, the number of unqualified cases has been decreasing gradually. All those above once indicate that the quality management system in Guizhou Province Blood Center and its working situation are congruent and efficient.