By: Steve Ferrell, Chief Compliance Officer
Whether you believe we are the descendants of ancient primates, the children of God or – as I do – the subservient vassals of Gozer the Gozarian, we are all human and we are all imperfect. As with anything our society values, accuracy does not come naturally to us. We may spend years cultivating our attention to detail and our pattern recognition skills, but no matter how careful we think we are, achieving true and consistent accuracy is a challenge we will continue to face until mighty Gozer returns to rain marshmallow Armageddon on our great cities.
As we conclude our ALCOA odyssey at long last, let’s consider the importance of accuracy in the lab. The enterprising realists among us have accepted the fact that even the best humans are just plain bad at it, and we now have all kinds of new and creative technologies to try to take mortal ineptitude out of the equation. Tragically, we haven’t figured out how to make software that operates itself (yet) so for the time being, the key to laboratory accuracy must involve both the right technology and the right people to operate it. As any primate will tell you: a fool with a tool is still a fool.
If you still rely on hand-spun spreadsheets to do your calculations, you are exposing yourself to a massive risk. As a general rule, spreadsheets are uncontrolled, difficult to secure, and their willingness to be copied and pasted means they tend to multiply like bunnies at some sort of bunny festival (if this becomes a trend, RURO is primed and ready to get into the carrot smoothie market).
Accuracy, therefore, is best achieved and best maintained with tools that are secure, configurable, and easy to audit. Further, SOP’s and work instructions that guide any kind of measurement, sample, or calibration have to be thoroughly vetted and consistently maintained to ensure their end product is as accurate as possible.
When we think of a lab tech interacting with a modern instrument we should visualize an equilateral triangle: the lab tech, the instrument, and it’s software all interacting smoothly and cohesively to produce an accurate result. Switchbacks, duplicate information, and outside tinkering only complicate the process, and jeopardize the accuracy of the final product. If the tech is trained, the instrument is calibrated and qualified, and the software is validated, accuracy – though never completely assured – is a much more likely result.
Training should provide the tech with a clear and comprehensive standard operating procedure that accounts for problems that may arise as well as driving efficiency, compliance, and accuracy. Too often, SOP’s are overworked and difficult to understand in an attempt to ensure compliance, and efficiency suffers. Onerous processes don’t always provide accurate results, driving the lab tech to a daily state of frustration is virtually guaranteed to produce errors along the way.
When done properly, validation and qualification essentially confirm a process’s accuracy through careful testing. Unfortunately, the development of these processes can also suffer from over-engineering in an attempt to account for every possible compliance issue, and although this is done with the best intentions, it typically produces more problems than it solves. Accounting for compliance is important, but it should be balanced with a reasonable level of clarity and simplicity to make processes suitable for real-world use.
Finally, the software you choose for you lab has perhaps the most vital role to play in the quest for accuracy. Archaic software with limited capabilities forces the user to come up with manual workarounds, complicating the paths that information must go through in the lab and leading to more opportunities for mistakes, as well as more fatigue and frustration for the lab tech.
Flexible solutions with up-to-date processes – like RURO’s LimitLIS – support better accuracy of lab information with more efficient processes, simpler workflows, and a layout that is intuitive and easy for lab techs to use and navigate.
As with all five of the ALCOA principles, accuracy of lab information is not just a lofty ideal, it’s achievable, even for us mere imperfect humans. With the right tools, the right people, and the right perspective, labs can operate at an extremely high standard of data integrity, and RURO’s software is specifically designed to help labs achieve that standard, which is why we take the ALCOA principles so seriously. For RURO, Data Integrity has never been a side dish; it’s baked into pies.