Cost Effectiveness of Adopted Quality Requirements in Hospital Laboratories

Background: The present study was designed in quasi-experiment to assess adoption of the essential clauses of par-ticular 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. Methods: The quality management intervention based on ISO 15189 was conceded through three phases; pre –intervention phase, Intervention phase and Post-intervention phase. Results: 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 respec-tively 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. Conclusion: The planned adoption of quality management requirements (QMS) in clinical laboratories had great ef-fect to increase the compliance percent with quality management system requirement, raise the average total cost ef-fectiveness, and improve the analytical process capability of the testing procedure.