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No matter how well-designed or carefully executed, laboratory testing doesn’t always go perfectly. Whether you’re working in a clinical lab, a quality control (QC) lab, or a research environment, there will be times when an assay result is inconclusive, an instrument hiccups, or something simply doesn’t look right.
When this happens, the lab needs to do more than just acknowledge the issue — it must manage it in a way that protects data integrity, complies with regulations, and keeps the workflow moving efficiently. A sophisticated lab informatics system can play a critical role by providing clear guardrails for what to do when things don’t go as expected, while also offering the flexibility to handle unusual cases that require human judgment.
Different labs have different ways of describing the same basic problem: a test result that can’t be trusted as-is.
In QC and manufacturing labs, a departure from expected procedures or results is generally referred to as a “lab deviation,” which requires documentation and investigation. In clinical labs, however, the same situation is often handled as a “requeue,” meaning the sample or test is sent back through the process, either partially or completely.
Regardless of the terminology, the underlying problem for all labs is how to move forward to achieve a valid result.
Most labs follow one or more of three well-established methods to handle assay results that fall outside what’s expected — also known as out-of-specification (OOS) results. Each approach is designed to isolate and rule out different possible sources of error. For example, is the fault with the sample itself, how it was prepared, or with the instrument that performed the analysis?
A lab informatics system can help your lab manage the different scenarios, whether deviations and requeues are routine or not.
In well-run labs, there are clear, documented procedures for about 95% of these non-happy-path events. Good lab informatics systems can help enforce these protocols by:
However, not every event fits neatly within the parameters of an existing protocol. Approximately 5% of the time, a deviation or requeue doesn’t match the standard playbook. That could be because multiple factors are at play, or the result is borderline but not unquestionably wrong. In these cases, a qualified human expert must make a judgment call.
Depending on the lab, the person making this decision could be the QC Manager, Clinical Lab Director, Quality Assurance Director, or other designated technical supervisor. This person might decide to investigate further, test additional controls, consult with the instrument vendor, or even halt testing altogether until the root cause is found.
When this happens, the lab informatics system’s flexibility is just as important as its guardrails. A good system should make it easy for qualified personnel to:
A specially designed workflow can help labs anticipate and provide a structured way to handle the unexpected.
When it comes to managing deviations and requeues, balance is key. An informatics system that’s too rigid can slow down the lab and lead people to bypass the system altogether, putting data integrity and compliance at risk. On the other hand, a system that’s too flexible can lead to inconsistent decisions, poor documentation, and costly mistakes.
The best lab informatics systems enable labs to handle expected and unexpected results. They provide clear guidance and standard workflows for routine issues, while also supporting human expertise and good scientific judgment when something unusual happens.
Your lab cannot possibly eliminate all surprises. However, with a well-designed informatics system in place, you can be ready for them. You can pivot quickly and automatically to a routine re-analysis, or you can initiate a complex investigation when a human touch is required.
If you’re currently reviewing your lab processes to improve efficiency, ask yourself: Does our lab informatics system help personnel handle assay execution that follows the “happy path,” as well as routine and non-routine exceptions? If the answer is no, it might be time to strengthen both the system’s guardrails and flexibility so the lab can deliver reliable results every time.
Talk to us about how to set up your lab informatics system to handle these complex scenarios.
