Quality management systems in ART are not just about compliance and legislation

Published 15 November 2019

A well attended Campus meeting in October heard that quality standards in an IVF centre - on embryo culture, traceability, risk management and evidence-based practice - depend on multiple factors, from the laboratory environment to the application of guidelines.

ART clinics' compliance with tissue handling directives and regulations will be impossible without the use of a quality management system (QMS) — and this should ideally incorporate the latest key performance indicators (KPIs). This was one message from the broad scope of a Campus meeting on Quality Management in ART held in October.

Other insights covered in this well attended event included the negative impact of 'toxic' environments on clinical outcomes, technical innovations to avoid IVF mismatches (such as facial recognition), tools to help manage risk, and the preview of an as yet unpublished ESHRE guideline on female fertility preservation.

ESHRE, the World Health Organisation and European Commission are among many organisations requiring or recommending clinics to operate a QMS. David Mortimer, president of Vancouver-based Oozoa Biomedical, stated that clinics without a QMS are at risk of paying out financially to correct avoidable problems. Moreover, results from a SWOT analysis presented by Mortimer showed that a QMS can switch a situation from crisis to proactive decision-making, and even lead to strategic success. Such quality management will also depend on measuring output using KPIs, benchmarking and control charts; indeed, Mortimer outlined how he achieved a ‘significant increase’ in the proportion of zygotes to blastocysts in his own lab using KPIs to track systems improvement.

Addressing the question of whether QMS has improved ART treatment, Mortimer presented data from Australia showing how the proportion of IVF multiple births is now at a record low. He attributed this to the increase in elective single embryo transfer (28.4% in 2002 vs 89% in 2017), which was achieved through clinics committing to the safest treatment possible as guided by best practice from the Fertility Society of Australia.

Thus, clinics should not see quality as an add-on, he advised, but instead should take systems apart, identify everything that needs improving and rebuild. Without an organisation-wide quality framework, there will only be short-term benefits for patients. From patient biology to the IVF lab environment, all factors must be taken into account. Even opening an incubator door repeatedly can compromise every dish inside — ‘staff need to think like an embryo,’ said Mortimer.

Conversely, a negative work environment, where staff fear retribution and managers lack leadership skills, will also affect outcomes. Mortimer presented results from a survey that showed nearly half of staff (48%) reduced their work effort intentionally when faced with rude behaviour.(1)

The importance of a positive work culture was echoed by Bryan Woodward, a freelance consultant embryologist who had visited labs ‘where embryologists are scared’. Staff achieve their best for patients and avoid errors when morale and communication are good. His recommendations for being a good manager included self-awareness tests, a personal mission statement, and learning to negotiate.

One clinical challenge for IVF clinics in meeting requirements for traceability is how to link a donor with recipients or offspring born. Ahmet Berkiz Turp, assistant professor at Silifke Mersin State hospital in Turkey, noted that the EURO GTP II project, in which ESHRE has a leading role, provides the practical tools to support good practices in tissues and cells preparation processes.(2) Biometrics could also become a reality in improving traceability in ART, with facial or iris recognition or algorithms of behavioural characteristics. However, Berkiz also noted the importance of ethics in these traceability developments, to ensure that biometric technologies will be compliant with European regulations on data protection. This could involve a registry where men, women and even embryos have biometric barcodes, with the data combined with single European codes.

Failure mode and effects analysis (FEMA) and root cause analysis (RCA) are among other emerging tools which may help minimise risk and ensure regulatory compliance. Created by the aerospace industry, FEMA has been recommended for use in healthcare such as in high-risk IVF processes. Embryologist Alessandra Alteri, from San Raffaele Scientific Institute in Milan, described results from a study in which she and colleagues did indeed find that FEMA could help eradicate human errors.(3) Similarly, data presented by Stephanie Herring, a quality manager from Wales Fertility Institute, Cardiff, also showed that RCA helped her group reduce incidents from 212 (in 2011/12) to 38 (in 2018).

ESHRE guidelines also set high standards for total quality management in ART. As an example presented to this meeting was a forthcoming guideline on female fertility preservation for post pubertal women, outlined by embryologist Daniela Nogueira from Toulouse, France. She admitted that in this case a lack of available good quality data has proved challenging.

With a draft expected by the end of 2019, the guideline aims to assist medical staff and patients evaluate the possibility of preserving fertility and identifying the most appropriate strategy to follow. Among the 24 key questions being explored by the guideline committee are the risk of re-implanting malignancy and how this risk might be overcome (eg, with an artificial ovary). Essentials listed by Nogueria for establishing a fertility preservation programme included written informed patient consent and multidisciplinary staff officially participating in decision-making.

Zdravka Veleva from the University of Helsinki, Finland, reviewed ESHRE's recently published guidelines on ovarian stimulation, a procedure which, she said, still raises controversy on how it should be carried out. The question of gonadotrophin dose in low and high responders remains disputed, although the guidelines do recommend a limit of 300 IU for any predicted low responder. The guidelines have also offered no recommendation for any adjunctive treatments in predicted low response, or for the use of letrozole.

Guidelines on ultrasound-guided oocyte retrieval were presented at this year's Annual Meeting in Vienna. Consultant Arianna D’Angelo from the Wales Fertility Institute in Cardiff was on a working group which finally made recommendations in ten phases of practice, from before oocyte pick-up, through preparation and procedure, and finally to quality assurance.

All ESHRE guidelines are now developed according to rigorous standards, with 'good evidence' that each recommendation is clinically effective. The ovarian stimulation guidelines just published began with almost 40,000 abstracts screened and assessed for the strength of their evidence. All ESHRE guidelines are now developed according to a published (2017) manual which pursues the whole process from topic selection through recommendations to publication and distribution.

However, ESHRE's senior research specialist Nathalie Vermeulen described the Society's guidelines and recommendation as merely a tool, and ‘not a cookbook’. So ESHRE can develop evidence-based guidelines for best practice, but the clinics must also be committed to maintaining a robust QMS - and to ensuring their staff and patients are happy. 

1. Porath C, Pearson C. The price of incivility. Harv Bus Rev 2013; 91: 114-21,146.

2. See https://www.eshre.eu/Europe/European-Union/Projects-regarding-ART/EuroGTP2/About.

3. Intra G, Alteri A, Corti L. Application of failure mode and effect analysis in an assisted reproduction technology laboratory. Reprod Biomed Online 2016; 33: 132-139.