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Inside the Lab Quality assurance and quality control, Regulation and standards

Quality Control and Jell-O

Jell-O was initially patented in 1845 and gained popularity over the next 100 years, leading to major gelatin innovations. Around the 1960s, Jell-O (a registered trademark of Kraft Heinz), arguably met its peak of innovation – a point at which families enjoyed Jell-O molds filled with carrots, lettuce, and even tuna. So, how is this related to quality control (QC)? Because, in my view, QC is currently awaiting its own Jell-O renaissance.

The QC process has been static for decades and has rarely seen major laboratory innovations. After obtaining QC data, laboratory professionals often have different interpretations or don’t know how to use it to decide on next steps. So why even run QC if you can’t use the results? Perhaps you feel the need to satisfy guidelines or meet accreditation requirements – or perhaps it has simply become a habit.

One key area for QC improvement is troubleshooting. I have witnessed laboratories start troubleshooting QC by rerunning it, crossing their fingers for passing results so they can move on with their day – but troubleshooting QC problems is an art and takes time (which means that people often try to avoid it). My concern is that people fall into a “get it done” mentality, forgetting the true purpose of QC. QC is supposed to ensure that patients receive the right results – every time. Running QC material until it passes is neither “quality” nor “control.”

Another focus for improvement is to transition QC from a reactive to a proactive process. By nature, people are reactive to things over which they feel they have no control. To me, it makes no sense to wait for something to go wrong before we take measures to fix it – especially in healthcare. Current health trends include addressing problems, such as lack of access to healthy food, with the ultimate goal of preventing conditions, such as obesity and diabetes. We know that being proactive about health can prevent disease – so why not take the same approach to QC? A proactive approach saves time in the long run but, when labs have limited staff and resources, reactivity becomes the default. Often, either motivation or opportunity is lacking to bring in the innovations that would change this default – and this benefits no one.

We live in an age where our phones are mega-on-demand encyclopedias and our cars drive us – so it’s frustrating to see that many laboratories still manually input QC points into a spreadsheet. We have lakes – even oceans – of QC data on diagnostic devices; billions of QC data points are automatically created each year, but few are tapping into that power.

The future of QC still needs a roadmap – ideally one that would mean we never have to rerun QC. In this information age, we need to take advantage of all available data and think of sophisticated ways to add more sensors to devices so more data can be collected. These intelligent systems will foresee problems before they occur, self-heal, and calibrate without missing a beat. But a sea change like this requires a massive alignment of policies, people, and technology to set the stage. And so we wait for someone to come along and add some hot dogs to this “Jell-O,” changing the game forever. The first attempt may be for better or for worse – but, no matter the outcome, improvement can only begin with a willingness to try.

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About the Author
Daniel Johnson

Assistant Director, Marketing for Informatics and Quality Solutions, Sysmex America, Lincolnshire, Illinois, USA

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