Hamza Alneil, Ahmed-Abakur Eltayib, Abugroun Elsir, Bakhit Siham, Holi Mohamed
Medical Laboratories Administration, Ministry of Health, Khartoum State, Sudan.
Iran J Public Health. 2013 Jun 1;42(6):552-8. eCollection 2013.
The present study was designed in quasi-experiment to assess adoption of the essential clauses of particular clinical laboratory quality management requirements based on international organization for standardization (ISO 15189) in hospital laboratories and to evaluate the cost effectiveness of compliance to ISO 15189.
The quality management intervention based on ISO 15189 was conceded through three phases; pre - intervention phase, Intervention phase and Post-intervention phase.
In pre-intervention phase the compliance to ISO 15189 was 49% for study group vs. 47% for control group with P value 0.48, while the post intervention results displayed 54% vs. 79% for study group and control group respectively in compliance to ISO 15189 and statistically significant difference (P value 0.00) with effect size (Cohen's d) of (0.00) in pre-intervention phase and (0.99) in post - intervention phase. The annual average cost per-test for the study group and control group was 1.80 ± 0.25 vs. 1.97 ± 0.39, respectively with P value 0.39 whereas the post-intervention results showed that the annual average total costs per-test for study group and control group was 1.57 ± 0.23 vs 2.08 ± 0.38, P value 0.019 respectively, with cost-effectiveness ratio of (0.88) in pre -intervention phase and (0.52) in post-intervention phase.
The planned adoption of quality management requirements (QMS) in clinical laboratories had great effect to increase the compliance percent with quality management system requirement, raise the average total cost effectiveness, and improve the analytical process capability of the testing procedure.
本研究采用准实验设计，旨在评估医院实验室对基于国际标准化组织（ISO 15189）的特定临床实验室质量管理要求基本条款的采用情况，并评估符合ISO 15189标准的成本效益。
基于ISO 15189的质量管理干预分三个阶段进行；干预前阶段、干预阶段和干预后阶段。
在干预前阶段，研究组对ISO 15189的合规率为49%，对照组为47%，P值为0.48；而干预后结果显示，研究组和对照组对ISO 15189的合规率分别为54%和79%，差异具有统计学意义（P值为0.00），干预前阶段的效应量（科恩d值）为（0.00），干预后阶段为（0.99）。研究组和对照组每次检测的年平均成本分别为1.80±0.25和1.97±0.39，P值为0.39；而干预后结果显示，研究组和对照组每次检测的年平均总成本分别为1.57±0.23和2.08±0.38，P值分别为0.019，干预前阶段的成本效益比为（0.88），干预后阶段为（0.52）。
临床实验室计划采用质量管理要求（QMS）对提高质量管理体系要求的合规率、提高平均总成本效益以及改善检测程序的分析过程能力有很大作用。
