Session 10 (QC Part 2) - Q&A

Questions for: Dr. David Mortimer

This is why the Vienna Consensus updated the 2nd Alpha consensus on cryo KPIs regarding the new routine use of blastocyst vitrification. But I believe it is too soon to consider updating the Vienna KPIs consensus.

An example of this would be in the late 1990s when the WHO recognized ART for male factor there was a need to change the clinical guidelines for male infertility from what was in their “WHO Manual for the Standardized Investigation and Diagnosis of the Infertile Couple” (CUP, 1991), and hence the “WHO Manual for the Standardized Investigation, Diagnosis and Management of the Infertile Male” (CUP, 2000) was published.

So, regarding “PGT 2.0” there might be justification to hold a consensus meeting on that, but artificial intelligence is still not even here, so in my opinion this would be premature

This is why the Vienna Consensus Group could not reach an agreed value for a BDR KPI. In fully optimized centres one might expect the great majority of blastocysts should be seen on Day 5, with some slow ones appearing on Day 6. We have used 60% (of zygotes reaching the blastocyst stage) for a Day 5 BDR. But different stimulation or trigger criteria or timing could generally slow down blastocyst development and/or cause blastocysts (particularly those created from post-mature oocytes) to have lower developmental potential.

Hence each lab should simply try to optimize their BDR KPI(s)

If it’s the values included in the Vienna Consensus then they were derived from the literature, the Expert Group’s own experiences, and in some cases the values were clarified by large datasets provided by some of the Group members.

If it’s the control mean and warning / control limits then these must be derived from your own historical data since the purpose of the control chart is to monitor whether the process is operating within your own historical performance criteria.

Some ART EMR systems include control charts in their internal reports, e.g. the Lab Performance Indicators report within the IDEAS system (www.mellowoodmedical.com), I’m not sure about other EMRs.

The “SMARTS” system that I showed in the final part of my talk is an analytics platform (currently in beta testing) that, while not actually being part of it, works with the IDEAS ART EMR, and can also integrate other external data sources with it. It is a value proposition add-on to the IDEAS system; at this time it doesn't work with other EMRs

I believe there are also some apps that can do this, but I’ve not used any of them. I think the data need to be entered separately into these apps for analysis.

I do believe that much of the variability in KPIs from period-to-period is caused by a combination of variable human practices and both equipment and environment fluctuations. Hence it is the Lab Director’s job to select and design systems that minimize such possibilities, and to train staff to be consistent in what they do and how they do it (which can be verified by ongoing IQC and PT [proficiency testing]).

Certainly it has been my experience auditing labs around the world that focus on quality in all its aspects does result in not only better overall success, but also lower variability (expressed as higher control means and narrower warning & control ranges in control charts).

Some ART EMR systems include control charts in their internal reports, e.g. the Lab Performance Indicators report within the IDEAS system (www.mellowoodmedical.com), I’m not sure about other EMRs. “SMARTS” is an analytics platform (currently in beta testing) that, while not actually being part of the IDEAS ART EMR, integrates with it, as well as with other related external data sources. It is a value proposition add-on to the IDEAS system and does not work with other EMRs at this time.

I believe there are also some apps that can generate control charts, but I’ve not used any of them. I think the data need to be entered separately into these apps for analysis.

Questions for:Dr. Elizabeth Hammond

GENERAL DISCUSSION: