Reproductive biomedicine online · 2026
Systematic standardization improves compliance and performance across a large IVF network through audits and digitally enabled quality management.
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Shah Naval, Dave Vivek, Chandra Vipin, Singh Navneet, Ghodke Babasaheb, Murdia Nitiz, Campbell Alison, Kakadiya Piyush, Ps Jishnu, De Satardu, Aggarwal Ritesh, Talwar Divreena, Mistari Walmik, Chittora Anurag, Murdia Kshitiz
Аннотация
RESEARCH QUESTION: Can systemic standardization via audits and digitally enabled quality management improve compliance and clinical outcomes across a large IVF network?
DESIGN: An ambitious initiative was undertaken to develop a laboratory audit programme involving recruitment, selection and practical IVF laboratory training of personnel to constitute a specialist audit team, aiming to enhance quality, consistency and clinical outcomes across a large IVF network. In total, 149 audit checkpoints were included alongside cloud-based dashboards enabling multilevel live reporting against benchmarks, with scorecards facilitating training and process optimization, while monthly growth charts displaying changes in competency levels supported a continuous quality improvement loop. Effectiveness was assessed by a retrospective, multicentric, cross-sectional analysis of 34,461 treatment cycles involving intracytoplasmic sperm injection over 3 years across 30 centres. Degree of conformity was compared across 149 checkpoints in five categories (laboratory management, process, key performance indicators, laboratory equipment and documentation) post-audit compared with pre-audit.
RESULTS: The primary outcome was compliance rate. Implementation of the audit framework improved the compliance rate significantly from a mean ± SD of 74.4% ± 7.6% pre-audit to 80.1% ± 7.8% post-audit (P = 0.002). Secondary outcomes included blastocyst rate, which increased significantly from a mean ± SD of 51.2% ± 7.6% pre-audit to 56.5% ± 8.2% post-audit (P < 0.001), and biochemical pregnancy rate, which increased significantly from a mean ± SD of 72.3% ± 6.5% pre-audit to 75.7% ± 4.8% post-audit (P = 0.002).
CONCLUSIONS: This investigation demonstrates that systematic audits and laboratory standardization may improve the compliance rate and embryological outcomes. These findings highlight the value of structured auditing, standardized practices, and continuous monitoring in enhancing IVF laboratory performance, and provide a practical framework for quality improvement across IVF clinics.
DESIGN: An ambitious initiative was undertaken to develop a laboratory audit programme involving recruitment, selection and practical IVF laboratory training of personnel to constitute a specialist audit team, aiming to enhance quality, consistency and clinical outcomes across a large IVF network. In total, 149 audit checkpoints were included alongside cloud-based dashboards enabling multilevel live reporting against benchmarks, with scorecards facilitating training and process optimization, while monthly growth charts displaying changes in competency levels supported a continuous quality improvement loop. Effectiveness was assessed by a retrospective, multicentric, cross-sectional analysis of 34,461 treatment cycles involving intracytoplasmic sperm injection over 3 years across 30 centres. Degree of conformity was compared across 149 checkpoints in five categories (laboratory management, process, key performance indicators, laboratory equipment and documentation) post-audit compared with pre-audit.
RESULTS: The primary outcome was compliance rate. Implementation of the audit framework improved the compliance rate significantly from a mean ± SD of 74.4% ± 7.6% pre-audit to 80.1% ± 7.8% post-audit (P = 0.002). Secondary outcomes included blastocyst rate, which increased significantly from a mean ± SD of 51.2% ± 7.6% pre-audit to 56.5% ± 8.2% post-audit (P < 0.001), and biochemical pregnancy rate, which increased significantly from a mean ± SD of 72.3% ± 6.5% pre-audit to 75.7% ± 4.8% post-audit (P = 0.002).
CONCLUSIONS: This investigation demonstrates that systematic audits and laboratory standardization may improve the compliance rate and embryological outcomes. These findings highlight the value of structured auditing, standardized practices, and continuous monitoring in enhancing IVF laboratory performance, and provide a practical framework for quality improvement across IVF clinics.