Keywords
quality control
personnel management
assisted reproduction
laboratories
How to Cite
Abstract
Study question: What is the frequency and type of adverse events in an IVF laboratory? Summary answer: Our results provide more information on the origin of nonconformances in IVF laboratories, indicating that they are rare and are mainly associated with human and communication errors. The coincidence of our data with other published reports suggests that our results could be useful for other embryologists and clinicians to anticipate and minimize risks. What is already known: Errors are part of the natural secondary effects of all human activities. The complexity of assisted reproduction (AR) laboratories means that no embryologist, regardless of his or her abilities, experience and qualifications, is exempt from committing them. Study design: Descriptive, retrospective, observational. Materials and Methods: Retrospective analysis of all adverse events in our database between January 2012 and December 2018. The 29,357 procedures performed in this period included oocyte retrieval, fresh and frozen embryo transfers, vitrifications, preimplantation genetic studies and andrology practices. Main results:The 29,357 procedures performed in this period included oocyte extraction, fresh and frozen embryo transfers, vitrifications, preimplantation genetic testing (PGT) and andrology practices. A total of 64 nonconformances were documented during the study period. 99.78% of procedures did not present nonconformances. When we analyzed them according to their impact, 50.00 % (32/64) were minimal errors, 18.75 % (12/64) moderate, 31.25 % (20/64) significant, without major errors having occurred. 43.75 % (28/64) of nonconformances were due to human error, 29.69 % (19/64) to communication problems, 15.63 % (10/64) to equipment or supplies failures, 7.81 % (5/64) to problems or complaints from patients and 3.13 % (2/64) were due to external factors. 53.13 % (34/64) of errors occurred in the embryology laboratory was, while 31.25% (20/64) took place in the cryopreservation unit, 12.50 % (8/64) in the andrology sector, 1.56 % (1/64) in the PGT laboratory and 1.56 % (1/64) were external to the laboratory. Limitations: Analysis of adverse events in a single Center. Wider implications of the findings: Despite the complex procedures typically performed in an assisted reproduction (AR) laboratory and the emphasis placed on quality control measures, reporting and analysis of errors in the AR environment is lacking on literature evidence.
References
ASRM. Guidelines for development of an emergency plan for IVF programs. Fertil Steril 2008; 90:S131.
Mortimer ST, Mortimer D. Quality and Risk Management in the IVF Lab. 2nd ed. Cambridge University Press, 2015.
Sakkas D, Barrett CB, Alper MM. Types and frequency of non-conformances in an IVF laboratory. Hum Reprod 2018; 33:1-9.
HFEA. Code of Practice and Directions 2020; https://www.hfea.gov.uk/aboutus/news-and-press-releases/2019-news-andpress-releases/new-version-of-thecode-ofpractice-has-been-launched/
Schiewe MC, Freeman M, Whitney JB, Vermilyea MD, Jones A, Aguirre M, Leisinger C, Adaniya G, Synder N, Chilton R, Behnke EJ. Comprehensive assessment of cryogenic storage risk and quality management concerns: best practice guidelines for ART labs. J Assist Reprod Genet 2019; 36:5-14.
Tomlinson M. Managing risk associated with cryopreservation. Hum Reprod 2005; 20:1751-6.
Sakkas D, Pool TB, Barrett CB. Analyzing IVF laboratory error rates: highlight or hide? Reprod Biomed Online 2015; 31:447-8.
Gawande A. The Checklist Manifesto. Picador Eds, New York, 2009.
Wiemer K, Kelk D. Before things go wrong: Minimizing Drama in the Embryo Lab. ASRM Interactive Session, 72nd Annual Meeting of the American Society for Reproductive Medicine. Salt Lake City, UT, USA, October 15-19, 2016.
Bender L. To Err is Human: ART Mix-Ups. A Labor-Based, Relational Proposal. Iowa Journal of Race, Gender & Justice 2006; 9(3).
Harper JC, Kennett D, Reisel D. The end of donor anonymity: how genetic testing is likely to drive anonymous gamete donation out of business. Hum Reprod 2016; 31:1135-40.
Elder K, Van der Bergh M, Woodward B. Troubleshooting and Problem-Solving in the IVF Lab. Cambridge University Press, 2015.
Rienzi L, Bariani F, Della Zorza M, Romano S, Scarica C, Maggiulli R, Nanni Costa A, Ubaldi FM. Failure mode and effects analysis of witnessing protocols for ensuring traceability during IVF. Reprod Biomed Online 2015; 31:516-22.
Rienzi L, Bariani F, Dalla Zorza M, Albani E, Benini F, Chamayou S, Minasi MG, Parmegiani L, Restelli L, Vizziello G, Nanni Costa A, and on behalf of the Italian Society of embryology, Reproduction and Research (SIERR), Italy. Comprehensive protocol of traceability during IVF: the result of a multicentre failure mode and effect analysis. Hum Reprod 2017; 32:1612-20.
Chamayou S, Ragolia C, Guglielmino A. Traceability in IVF depends on each of us. Current Trends in Clinical Embryology 2017; 4:1-7.
Cimadomo D, Ubaldi FM, Capalbo A, Maggiulli R, Scarica C, Romano S, Poggiana C, Zuccarello D, Giancani A, Vaiarelli A, Rienzi L. Failure mode and effects analysis of witnessing protocols for ensuring traceability during PGD/PGS cycles. Reprod Biomed Online 2016; 33:360-9.