The impact of audit in embryology laboratory and its outcome - A multicentric study

Abstract Study question Would establishing an audit division in the embryology department of a well-organized multicentric IVF chain improve compliance thereby improving laboratory Key Performing Indicators (KPIs)? Summary answer The internal audits not only helped in increasing compliance but also KPIs like blastocyst rate, good blastocyst rate and β-HCG rate across various centers. What is known already Audit plays an important role in multiple industries worldwide. It has been proven to improve compliance with system, process and productivity of the organization. It helps an organization accomplish its objectives by using a systematic, disciplined approach to evaluate and improve the effectiveness of risk management, control and governance processes. As every organization has its own set of SOPs and KPIs there’s no universally accepted audit process; hence we introduced and implemented an indigenously designed audit system to ensure compliance and optimize laboratory performance as per the organizational Standard Operating Protocol (SOPs) to verify the Quality Management System (QMS) implementation. Study design, size, duration A retrospective cohort study was conducted in 30 centers of Indira IVF across India. Audits were planned in 2021/22 and KPIs were compared with pre and post-audit periods. Study duration was April-2019 to March-2022. Various parameters were used to analyze compliance based on checklist of 120 checkpoints divided into 7 categories like facility & lab management, laboratory process, SOP implementation, etc. Audit covered every critical area with 360-degree approach including people, equipment, facility & processes. Participants/materials, setting, methods The compliance rate was considered as the primary outcome and blastocyst, good blastocyst and β-HCG rate were taken as secondary outcomes. Pre-audit (Group-1) and post-audit (GrouP-2) outcomes were compared by paired T-test. The change in compliance rate was calculated as (Average Compliance after 2nd Audit – Average compliance in 1st Audit)/ Average Compliance after 2nd Audit*100. All p < 0.05 were considered statistically significant. Statistical analyses were performed using Statistical Package for social science (IBM SPSS), V28.0. Main results and the role of chance The average percent increase in compliance rate (74.03 ± 7.49 to 80.0 ± 7.94; p < 0.001) was statistically significant. Considering a team of 100 plus embryologists and 175 plus doctors panned across India, this improvement was substantial. The increase in average total blastocyst rate (48.48 ± 15.01 vs 54.52 ± 12.19; p < 0.001), average good blastocyst rate (29.15 ± 9.85 vs 31.05 ± 8.37; p < 0.02) and average β-HCG success rate (71.73 ± 9.97 vs 75.16 ± 8.28; p < 0.001) in G1 and G2 respectively was statistically significant. With respect to 30 individual centers, a statistically significant increase was found in 15 centers for blastocyst rate, in 16 centers for good blastocyst rate and in 7 centers for β-HCG success rate. Leaving 11 centers with blastocyst rate, 7 centers with good blastocyst rate and 17 centers with β-HCG success rates showed improvement though it was non-significant. All audits were carried out by independent competent and qualified auditors. Considering the above-mentioned data, we observed that audit is playing a very vital role in quality management systems. It helps to establish compliance with systems, processes and SOPs thereby improving immediate laboratory KPIs and overall outcomes for even established organizations. Limitations, reasons for caution Due to the Covid-19 pandemic, data from April 2020 to March 2021 could not be collected for analysis. The study has been conducted till β-HCG outcomes. Further, implantation rate and live pregnancy has not been analyzed. Wider implications of the findings “Audit system” plays a very vital role in the IVF laboratory for even SOP-driven organizations to ensure stringent adherence with regards to implementing and ensuring compliance. It is highly recommended that an audit system should be a part of every organization to improve QMS and overall outcomes. Trial registration number not applicable