Gajjar Disha, Agravatt Ashishkumar, Khubchandani Asha, Parchwani Deepak N
BJ Medical College and Civil Hospital, Ahmadabad, Gujarat India.
All India Institute of Medical Sciences, Rajkot, Gujarat India.
Indian J Clin Biochem. 2024 Apr;39(2):264-270. doi: 10.1007/s12291-022-01094-0. Epub 2022 Nov 11.
Implementation of Quality indicators (QIs) plays an imperative role in improving the total testing process, as it provides a quantitative basis for evaluating the laboratory performance. Besides monitoring of analytical quality specifications, several lines of experimental and clinical evidence have alluded a pivotal role of extra-analytical phases in improving the quality of laboratory services and therefore a relevance of pre- and post-analytical steps have been speculated on the overall quality in the total testing process and consequently on clinical decision-making. This was a retrospective study designed to evaluate and review different extra-analytical quality indicators in NABL accredited clinical biochemistry laboratory at BJ Medical College and Civil Hospital, Ahmedabad, Gujarat in an endeavour to ameliorate the performance of the laboratory. All Clinical Chemistry Laboratory test requests with their respective samples from January 2018 to December 2021 were included in the study. A total of 1,439,011samples were processed, and were evaluated for seven QIs [(% of number of suitable samples not received; QI-8), (% of number of samples received in inappropriate container; QI-9), (% of number of samples hemolysed; QI-10), (% of number of samples with inadequate sample volume; QI 12) (% of number of samples received mismatched; QI 15), (% of number of samples reported after turnaround time; QI 21) and (% of number of samples with critical values informed; QI 22)] based on defined criteria of Quality Specification given by International Federation of Clinical Chemistry. Total number of preanalytical errors was 53,669 (3.72%). Among the preanalytical errors, inadequate sample volume (2.37% of total samples; 63.49% of total pre-analytical errors) was the most common anomaly followed by Not received samples (24.18%) hemolysis (8.26%) mismatched (3.91%) and 0.14% samples were received in Inappropriate container; manifesting that the error frequency was unacceptable for QI 21 and QI 8, acceptable for QI 10, minimally acceptable for QI 15 and optimum for QI QI 9. Furthermore, there was year-wise progressive decline in error rate of inadequate sample volume, hemolysed sample received and mismatched samples. Total number of post analytical errors were 19,002 (1.32%). TAT outlier and critical values communicated were the two QIs evaluated for this phase and results of both QI were within acceptable limits. Quality indicators serve as a tool to monitor process performance and consequently derived error rates warrant active intervention to improve the laboratory services and patient health care. Dissemination of certified documents, regular staff training and evaluation needs to be conducted.
质量指标(QIs)的实施在改善整个检测过程中起着至关重要的作用,因为它为评估实验室性能提供了定量依据。除了监测分析质量规范外,多条实验和临床证据表明分析前和分析后阶段在提高实验室服务质量方面具有关键作用,因此推测分析前和分析后步骤与整个检测过程的总体质量相关,进而与临床决策相关。这是一项回顾性研究,旨在评估和审查艾哈迈达巴德市古吉拉特邦BJ医学院和市民医院NABL认可的临床生物化学实验室中不同的分析前质量指标,以努力改善该实验室的性能。2018年1月至2021年12月期间所有临床化学实验室检测申请及其各自的样本都纳入了该研究。总共处理了1,439,011个样本,并根据国际临床化学联合会给出的质量规范定义标准对七个质量指标进行了评估[(未收到的合适样本数量百分比;QI-8),(在不合适容器中收到的样本数量百分比;QI-9),(溶血样本数量百分比;QI-10),(样本量不足的样本数量百分比;QI 12),(收到的不匹配样本数量百分比;QI 15),(周转时间后报告的样本数量百分比;QI 21)以及(报告临界值的样本数量百分比;QI 22)]。分析前错误总数为53,669(3.72%)。在分析前错误中,样本量不足(占总样本的2.37%;占总分析前错误的63.49%)是最常见的异常情况,其次是未收到样本(24.18%)、溶血(8.26%)、不匹配(3.91%),0.14%的样本在不合适的容器中收到;这表明QI 21和QI 8的错误频率不可接受,QI 10可接受,QI 15最低可接受,QI 9最佳。此外,样本量不足、收到溶血样本和不匹配样本的错误率逐年呈下降趋势。分析后错误总数为19,002(1.32%)。周转时间异常值和传达临界值是该阶段评估的两个质量指标,两个质量指标的结果均在可接受范围内。质量指标作为监测过程性能的工具,因此得出的错误率需要积极干预以改善实验室服务和患者医疗保健。需要进行认证文件的传播、定期员工培训和评估。