参加美国病理家协会常规化学能力验证的不合格原因分析与探讨

The Causes of Unsatisfactory Performance in General Chemistry/Therapeutic Drugs Proficiency Testing with the College of American Pathologists' Programs at Hospital from 2012 to 2017

目的通过对我院医学检验科生化专业组2012~2017年连续6年参加美国病理家协会(College of American Pathologists,CAP)组织的常规化学能力验证计划的成绩进行统计分析,全面评价检测性能,发现存在的问题并对其进行改进,为质量控制提供依据,提高检测结果的准确性。方法评估首都医科大学附属北京世纪坛医院医学检验科生化专业组2012~2017年参加CAP常规化学的PT结果,对失控项目的原因进行统计分析。结果 2013年项次合格率最高,为100%;2014年项次合格率最低,为87. 5%;共有19个检测项目在2012~2017年成绩全部为100分,13个项目出现过成绩不合格;导致项目不合格的所有原因中,PT样本问题最突出,占68. 75%;其次是检测系统问题和分组不恰当,均为9. 38%,随机误差占比6. 25%;技术问题和书写错误占3. 13%。结论 CAP的能力验证活动可以用于对实验室的检测能力进行评估,对2012~2017年参加CAP的常规化学能力验证成绩进行总结,分析探讨不合格原因并采取相应纠正措施,可以进一步提高实验室结果的可靠性、准确性及可比性,以保证实验室对患者的服务质量。

Objective To evaluate the College of American Pathologists′（CAP）General Chemistry/Therapeutic Drugs Proficiency Testing performances for our laboratory with selected analyses and tests,so to identify existing problems for improvement of the laboratory quality management system in laboratory process. Methods We used the data from the Beijing Shijitan Hospital,a Capital Medical University affiliated hospital.The data of the Department of Clinical Laboratory Medicine General Chemistry/Therapeutic Drugs PT program from 2012 to 2017 was used to characterize the quality of testing in the Chemistry specialty.The reasons for all unacceptable results were sorted into 6 groups. Results From 2012 to 2017,a total of 19 of 32 analyses and tests （59.4%）achieved full scores （100%）,whereas 13 analyses and tests failed to reach the standards of satisfactory.Percentage of acceptable results for all analyses in 2013 was the highest （100%）during six- year period.The reasons for unacceptable results were identification errors in PT specimen problem （68.75%）,methodological problems （9.38%）,wrong peer group used （9.38%）,random error （6.25%）,technical problems （3.13%）,and clerical errors （3.13%）. Conclusion These data imply that methods- based Proficiency Testing program of CAP analysis can facilitate the assessing of the PT performance of chemistry section of laboratory services.