In my last blog post, I provided a framework for how validation fits into the overall change management process within a diagnostic testing laboratory (Read about validation now). In this blog, I will consider some common reasons that clinical diagnostic laboratories need to perform validations in order to support introduction of process changes.
Many laboratories are surprised to learn that changes across each segment of the testing workflow can result in the need to validate processes. As I said previously, the risk of each change should be considered in advance of implementing the change and the validation activities should test for the anticipated risks.
The Pre-Analytic Phase
The pre-analytic phase of diagnostic testing begins with the collection of the primary specimen from the patient and typically ends after the specimen is received, accepted, accessioned, and stored by the diagnostic testing laboratory (Read more about the pre-analytic phase).
The most common types of changes to the pre-analytic phase of diagnostic testing that I see that requires some level of validation include:
Changing the primary specimen type
Changing the transport conditions of the primary specimen type
Changes to the way that diagnostic tests are ordered (e.g. change from paper-based to electronic orders)
Changes to the clinical meta-data on the test requisition form
The Analytic Phase
The analytic phase of diagnostic testing includes the testing steps where the primary specimen (and the associated secondary samples) is manipulated physically or chemically (Read more about the analytic phase).
Most commonly on the analytic side of diagnostic testing, I see changes to:
Changes to the chemical steps of the analytic workflow (e.g. incubation time/temperature, concentrations of reagents, volumes of reagents, etc)
Changes to the storage conditions of intermediate products in the analytic workflow (e.g. storing next-generation sequencing libraries at -20°C instead of -80°C)
Changes to the diagnostic algorithm
Changes to the assay cut-offs
Moving the laboratory and/or laboratory instrumentation
The Post-Analytic Phase
The post-analytic phase of diagnostic testing includes the steps that occur inside the laboratory and outside the laboratory after the test result has been generated. The post-analytic phase includes processes such as quality control evaluation of data, generation of a test result report, and delivery of the test result report (Read more about test result reporting).
For the post-analytic phase of diagnostic testing, laboratories need to validate changes to:
QC processes (e.g. responsibilities, metrics, etc)
The test result report (e.g. content, layout, etc)
Test result report delivery method (e.g. test result report faxing changing to electronic methods)
No matter what the scope of changes looks like for your diagnostic testing laboratory, make sure your laboratory has evaluated the potential risks associated with the change(s), planned and executed appropriate validations, and monitored processes for negative impacts of the changes. Changes that require validation can impact any phase of the diagnostic testing workflow. If your laboratory has questions about how to assess risks to your laboratory or how and when validate changes to your diagnostic laboratory, reach out to an experienced CAP/CLIA Laboratory Director and CLIA laboratory builder (Contact us).
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