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What Do Standard Operating Procedures

Have To Do With Your Lab Software?

by

Eban Tomlinson

It might come as a surprise to some laboratory managers, but a lab’s standard operating procedures (SOPs) offer software consultants key insights into the workings of your lab. They also describe how your lab software should behave—assuming they are up to date.

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In this two-part series, we’re going to explore how SOPs relate to your lab software and how a software consultant can use them to reduce errors within your workflows.

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What makes SOPs so important?

SOPs are formalized documents that outline procedures. They include step-by-step instructions that enable staff to perform tasks the same way each time regardless of who is following them.

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Clinical diagnostic laboratories use SOPs to help ensure process compliance and to aid in quality control and quality assurance. It’s up to each laboratory to compose clear and understandable SOPs that adhere to the regulations that apply to its business.

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Because comprehensive SOPs are required for regulated laboratories, they should be followed as written. That means labs have to keep them up to date, so they match exactly how processes should be performed. In our view, they should be living documents, not ignored in a binder on a shelf. When an auditor performs any type of inspection, SOPs are the first thing they look at—they’re a lab’s first line of defense.

Is your LIMS helping or hindering lab analysts following SOPs?

Laboratory Information Management Systems (LIMS) tend to assume users are following a procedure correctly. What if your LIMS or other laboratory software could do better than that? What if it could guide analysts to follow your SOPs?

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At Semaphore, we believe that the user interface (UI) of your lab software should support your analysts and make their jobs easier. An interface that closely matches your SOPs makes it simpler for analysts to follow procedures and reduces the potential for errors. That’s why we always ask to see SOPs when we start working with a new client.

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We consider SOPs to be a form of declarative requirements documentation. As long as your SOPs accurately reflect how your lab analysts should perform a procedure, we can use them to correctly map lab procedures to software functions when we’re building your LIMS. A well-designed user interface should essentially walk analysts through an SOP.

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At the same time, just as an SOP should be a living document, your software needs to be updated as processes change. When you refine your SOPs, it’s critical that the software is updated to match in unison.

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SOPs must be up-to-date and accurate

In a regulated industry like clinical diagnostics, composing SOPs that accurately reflect procedures and then following them is imperative. It ensures compliance in the event of an audit, but, more importantly, it ensures quality and reduces errors, ultimately improving patient safety.

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When it comes to your lab software, usability is key. Lab software should always enable your analysts to do their best work. Dealing with a confusing user interface introduces challenges that could otherwise be avoided.

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Clinical diagnostic lab procedures are complex. Multiple calculations and analyses go into processing a patient sample. Ideally, the software should hide that underlying complexity while comfortably guiding an analyst through a procedure.

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Watch for our second post in this series, which will explore how a software consultant can use SOPs to reduce errors within your workflows.

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What have been some of your biggest struggles with your lab software user interfaces? Contact us and let us know.

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