IVF Quality Control in the Cloud
Dr. Carol Lynn Curchoe,
10 February 2020
Without question, laboratory quality control and assurance must be performed routinely in an IVF lab. While the embryologist's role in achieving and contributing to quality through safety in the assisted reproduction lab is obvious; appropriate levels of monitoring, what to monitor, and the best ways to monitor it are surprisingly unclear. Until just recently, the anatomy of a liquid nitrogen dewar failure, i.e. how a storage vessel behaves when the vacuum is breached, was unknown. Laboratory staff are driven witless trying to monitor (sometimes multiple times a day), record, and ensure that the laboratory staff, equipment, and environment remains within the parameters of the lab’s QC program. All of this tedium is archived on paper — relegated to long term storage closets and unconnected to patient outcomes; begging the question; are we wasting valuable lab resources, and staff time, while contributing to embryologist burn out too?
Staff competency is a crucial component of the IVF laboratory’s quality management system (LQMS) because it directly impacts clinical outcomes. Embryologists must be competent to make dozens of clinical decisions that can affect cycle outcomes. Certain IVF key performance indicators (KPIs) are used to continuously monitor and assess culture conditions.
Digital and “cloud based” solutions to reveal malfunctioning instruments and environments have been best practice tools for over 20 years in other industries. Why not for staff QA in the IVF lab too?
ART Compass is a new paradigm— digitalizing staff related competency assessments, training documentation, annual procedure evaluations, and real time “in-cycle” embryologist KPI statistics— for 21st century IVF lab QC/QA in “the cloud”.
ART Compass can be used to deploy standardized training and detailed survey protocols to embryology and andrology technicians, evaluate competency, track inter-laboratory and inter-technician variation, and view comparative data at the technician and clinic level.
Our mobile application (and web-based portal) technology allows for rapid data collection, real-time analysis, management and distribution of multi-media files, automated reporting and the ability to utilize device hardware features, such as; the phone’s camera, image editing with finger, and biometric (fingerprint) data to enhance security.
Other emergent digital QC/QA tools for the IVF lab represent points of great potential if integrated with ART Compass and/ or together with each other or existing EMRs. Electronic witnessing systems using RFID tags, QR codes, barcodes or other image capture approaches are being employed more and more, and could be integrated with ART Compass for complete accuracy, to reduce the time that is spent recording “who performed which” procedural step, and to tie those data in with outcome data.
Recently, a web of IOT sensors for real-time monitoring of room temperature, humidity, volatile organic compounds, and door open count among others, showed promise for sensitive detection. These data would be quite intriguing to overlay on embryologist KPIs and clinical outcome data collected via ART Compass (or other methods).
IVFQC’s (a cloud-based application to collect, store, retrieve and analyze instrument quality control) recent publication lends support to the notion of standardization of quality control parameters and hints at the potential to integrate with electronic health records to relate measured parameters to clinical outcomes.
Lastly, new thermal imaging cameras connected to mobile apps allow constant monitoring of external signs of cryostorage failure, like; vapor, frost, and temperature change of the air or storage vessels. Weight based monitoring systems also allow for continuous monitoring and the detection of weight changes to just a few hundred grams. These could provide additional insights into hard to measure variables: How long are tanks open while daily or weekly measurements are taken, during LN2 filling, or when inventory is performed?
Why did I, together with some of the most luminary scientists in IVF QC / QA, create ART Compass? It grew out of frustration. Starting out in clinical embryology, I had no way to compare my clinical decision making to people who had many years in the field. I had no way to easily know if my judgment in grading embryos was correct, or even close, except by sitting with senior embryologists at the microscope. Of course, senior embryologists don’t REALLY have time for this activity, given their many responsibilities and clinical workload. ART Compass started as one single competency assessment module. It has grown beyond our wildest expectations, to include a recently awarded grant from the State of California, and a collaboration with the World Health Organization to deliver andrology image content from the upcoming 6th edition laboratory manual for the examination and processing of human semen. We invite you to join us today!
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