It’s obvious to us as scientists what we mean by data capture, it’s simply the process of gathering and recording data. As developers of Matcher, an IT based system for error prevention and traceability, the thing that continues to stimulate, excite and challenge us every day is how we go about capturing data and how it can deliver a real benefit to making your lives easier better and safer, with as little effort as possible, especially when we consider that effort equals cost.

There’s a phrase that often gets used when we consider data capture and that is “garbage in garbage out” or GiGo.

This is the concept that flawed, biased or poor-quality garbage information or input produces a result of output of similar garbage quality.

And as developers, we have to consider this when we design systems for data capture because what’s the real point of a database? And how does knowledge become power? I’m talking about real power and purpose – not just box ticking to satisfy the regulators for external compliance.

In our view, the real point of data capture is to automatically answer the questions that help enforce smart decisions quickly. Preferably the most important questions that help you to become best in class, help you to attract customers or patients to your fertility centres, help you to become rich and famous and help you to cover your own backside.  Fertility centres are after all safety critical organisations, where a single, seemingly trivial mistake by an individual can have serious long lasting and sometimes catastrophic consequences for the one individual who had the oops moment, the clinic, the whole organisation and certainly the patients involved.

This doesn’t even have to be a mistake, there are many kinds of hazards we are exposed to, lurking, ready to catch us unawares.   It could be something as simple as failing to spot a trend in clinical outcomes for example, or someone misinterpreting one element of an SOP or a result relating to quality. Just running out of a particular consumable product that happens to be mission critical can be catastrophic in certain circumstances and working too slowly or even too quickly can also have dire consequences in your profession.

Let’s work backwards. Identifying exactly what are our most important questions is probably the best place to start.  Some would refer to these as our key performance indicators (KPIs), this is correct, but I think it could be even simpler than that.

It’s questions like:

• How many errors have we made this week or this month or this year?
• What type of errors were made?
• Who made those mistakes?
• In what location?
• As part of what procedure?
• And which patients and staff and embryos and gametes have been affected?
• And probably most importantly, what was the reason for the error?
• How to mitigate the errors or prevent them from happening again?
• How often are we deviating from our prescribed SOPs?
• And who’s deviating?
• And why?
• And do we therefore need to change our process maps or workflow?
• Questions like how many cycles and of what type are we providing on a monthly basis or each year?
• Simple questions like have we finished all of our tasks for the day?
• And what procedures are still outstanding?
• What still needs to be done before we go home this evening?
• How much time are we spending at the workbench?
• Why or how is one embryologist performing tasks faster than another embryologist?
• And how are they comparing against the average times for specific procedures and process?
• How much space do we have left in our cryo vessels?
• And how many gametes or embryos have we frozen this month or this year?
• And where are they?
• Practical questions like do we have any products that we need to reorder?
• Or are any of our products close to their expiry dates?
• And in the event of a product recall – which patients have been in contact with the recalled product lot and in what cycle and as part of what procedure?
• And are there any patients that require renewal of consent for storage?

The list of questions goes on, but it doesn’t have to be exhaustive, it’s just a case of designing the dashboard you need to make informed decisions in relation to the way you work, in real time. Sounds simple?  It is – when you have the right tools.

Having a simple dashboard that tells the right people at the right time that hell is about to break loose is a good place to start. We call these Insights.

And when we know what the questions are we need to answer, and what we want from the data, we then need to decide how best to capture the data in the most efficient way.

Sure, we can implement a system for writing it down. It captures the data, right? It’s what the regulators want, right? It’s the cheapest way of doing it because we don’t need to implement an expensive digital solution, right?

No. Wrong on all three counts.

Writing stuff down on paper in patient records or cryo inventory, or lot tracking and especially handwriting critical information on dishes and tubes and cryopreserved items like gametes or embryos is absurd in a digital world and quite dangerous. We don’t do it at home so why are so many clinics still using manual paper-based systems and records at work. Why are we still using two people to check procedures when we don’t have to? It’s inefficient and it’s definitely not the cheapest way of working – it’s actually by far the most expensive way of working. Especially when you consider how much time and resource it would take to calculate the answers to some of the questions with a piece of paper and a calculator or in an excel spreadsheet.  In many cases, like in the event of a product recall for example, I don’t believe it would even be possible.

To be effective, we must capture digital data in real time at the point of performing a procedure or a task for that data to become useful and truly powerful. This isn’t optional, it’s critical to any total quality management system. For some tasks, even a digital EMR doesn’t do this effectively because you are often still manually entering data into tables on a PC away from the work area retrospectively instead of prospectively in real time.

And this is where barcodes are the king of the data capture jungle.  Barcodes offer the perfect solution and it’s what they are designed for.

And there are several reasons why barcode systems offer the perfect solution for realtime data capture.  Let’s consider some of these.

• Barcodes are ubiquitous. They can be and are already used on almost everything, including all of the consumable products coming into contact with the gametes and embryos, the medicines being prescribed to the patients, even the locations and apparatus can be barcoded.
• They are small, versatile and consumable.
• They’re cryo-proof, as well as waterproof and oil proof.
• Portable, barcodes provide the freedom to capture data anywhere, not just in one location, which is important so there are no gaps in your chain of custody.
• Globally unique not only to the patient but also to the individually numbered gametes, embryos and biopsies which is especially important for verifying correctly numbered gametes and embryos through a process like biopsy and vitrification and also for confirming the fate of specific embryos for transfer, disposal or movement into and out of your cryostores.
• They can be assigned to every patient, product and process in advance, completely eliminating the need for a human decision.
• Barcodes are the link between the real physical world managed by humans, and the virtual digital world managed by computers – like a wormhole in space!

When you are considering the cost benefits of implementing an electronic witnessing system like Matcher, it’s a mistake to just think about the value of error prevention.  Of course, this is important because who wants to make a mistake when you’re moving gametes and embryos around? No-one wants the wrong baby.

But you should also be considering the value of real time data capture and traceability. This is just as important, and in my view probably more important.  Error prevention is just one part of traceability and Matcher is more than just witnessing, because the system provides you with the tools to prove what you did and analyse what you did with physical evidence, literally at the click of a button.

For example, when you witness a barcoded procedure with a benchtop scanner at the work bench or with a Pocket Matcher in the operating room or cryostore, you’re not just checking the ID of the patient. In the 8 seconds it takes you to capture the barcodes, you are actually capturing a massive of amount of immensely significant data, the type of which can be used to answer your most important questions.

This includes:

• Who was the patient?
• What was the procedure?
• Verification it is the right procedure, and if not why not?
• Was it Match confirmed and if not why not?
• When and where was the procedure performed?
• Who was responsible for the procedure?
• Who else was involved in the treatment?
• What are all of the product lots used for that specific procedure including Labware, media, even medicines and surgical equipment?
• Was it the right numbered gamete or embryo and if not why not?
• Who was the donor?
• Verification it was the right donor
• The cryo location
• The product stock levels
• The day of the cycle
• The date and time of the freeze

And it even takes a photograph! And a picture tells a thousand words.  We are aware of cases where photographic evidence has been successfully used to demonstrate that a process was followed correctly, making them worth their weight in gold.

Traceability is not just important, it’s a vital core component of every fertility center’s total quality management system for a whole variety of reasons. A fertility center simply could not function and would not last for very long without adequate traceability systems in place.

And in terms of quality control, you can now categorically prove the 5 R’s. Right Patient and Embryo, Right Time, Right Place, Right Process and of course, Right Product.  This is what we really want to prove.

And this ultimately leads to best practice. For example, it’s important for helping to drive efficiencies which leads to improved outcomes and results.  It’s important for ensuring patient and staff safety, quality control, regulatory compliance, and efficiency of the healthcare system, and probably most importantly, if implemented correctly it can even mitigate the risks of error and prevent mistakes.

And where could it lead us.  Confounding data or confounding variables, the type of data we are referring to, are the cornerstones of root cause analysis and the reasons why outcomes, especially those influenced by biological systems are what they are. They are the reasons why things go well and the reasons why things go wrong.

Imagine a world where database service providers work together to integrate systems. We can potentially become even more powerful because we can then potentially cross reference the data captured from multiple databases for enhanced root cause analysis for instance or even for unlocking the secret formulae to what makes the perfect embryo.

But this isn’t just a suggested ideal for the future – it’s already happening.