ERRORS IN ART 2

Quality management and reducing the risks of errors in the IVF lab

Published 11 December 2020

A well attended Campus meeting in November heard how quality management systems and a willingness to discuss all mishaps and near-misses reduce the risks of errors in the ART clinic.

Errors in ART will never be eradicated, but those taking part in a November Campus meeting were told that their risk can be reduced through quality management systems (QMS), adherence to international guidelines and a culture of openness among laboratory staff.

Benefits of a QMS include a reporting system for adverse events, ongoing education and a risk matrix, with ISO 9001 the most widely used and internationally recognised. French midwife Valerie Blanchet de Mouzon noted that international standards can help identify the potential cause of risks and check that they’re under control. Using her clinic in France to demonstrate how this works in practice, de Mouzon documented how the lack of an operating theatre for general anaesthesia would score high on a risk matrix given the pain it might create for patients. The procedure to put in place would be for the clinic to discuss increased operating room planning and organisation. Other recommendations she shared included a labelling system for test tubes, SMS text messaging to confirm timing for oocyte trigger injections, and training staff on a simulator to reduce the risk of events such as intro-abdominal bleeding. 

Alessandra Alteri, deputy of the SIG Safety & Quality in ART, proposed other QMS options, namely root-cause analysis and Failure Mode and Effects Analysis (FMEA). For more insights into the core aspects of QMS, she recommended the SIG SQART’s e-learning course. This emphasises that clinics must not only report errors to regulators but also discuss them among colleagues to prevent future errors.

However, Heidi Mertes, Co-ordinator of ESHRE’s SIG Ethics & Law, noted that errors are not always disclosed for reasons including fear of disciplinary action and workplace blame cultures. Nevertheless, she emphasised that under-reporting leads patients to assume that most practitioners are flawless - although gaining the trust of patients is not about being infallible. So the optimal clinic culture is one committed to patient safety, said Mertes, and one where staff feel safe in admitting errors. To back up her argument for transparency, she presented evidence of increased patient satisfaction among patients at a US hospital which is proactive in identifying adverse events, offers patients full disclosure and rapid/fair compensation as well as an apology.(1)   

Following questions from the online audience, there was some debate among presenters whether patients should be informed or not about all errors. Opinion was divided as to whether this would cause unnecessary anxiety or if it is a clinic’s duty. Disclosure isn’t always easy, said one, even if a near miss, but mistrust is even worse.

1 Beaulieu D. Disclosure, apology and offer: A new approach to medical liability. Massachusetts Medical Society Summer 2012; https://www.macrmi.info/files/3413/5523/9411/final_255939CM_VS_reprint_0812_2.pdf.

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