One of the most common questions I get from my diagnostic laboratory clients concerns validation—when and how to do it. As diagnostic laboratories expand their testing menus or make changes, diagnostic laboratories encounter a lot of uncertainty on how much validation to perform. In this mini-series, I will discuss some of the most common types of validations that CLIA labs perform as the labs change over time. To get us started off, I will walk you through the basic principles to consider before your laboratory implements a change.
Risk Management
Clinical laboratories must be very cautious as the lab changes over time. A time of change within the laboratory can put patient safety and laboratory operations at risk if the changes are not managed properly. For this reason, your laboratory needs to assess and manage risk in advance of implementation of the change. Your experienced laboratory team should assess the potential risk to patient safety and the potential risk to laboratory operations stability for any change planned for the laboratory. The risk management team should include individuals who are skilled with tools pertaining to risk management and understand the technical aspects of your laboratory’s testing menu.
Planning Appropriate Validation Activities
The laboratory should create formal validation plans and protocols to ensure a smooth implementation of the change. The scope of validation activities should reflect the risk to patient safety and the risk to laboratory operations stability. The validation protocols must be designed to ensure strong statistical powering for the study. For example, potentially rare events with severe risks to patient safety should be considered within the validation activities.
All validation protocols must include agreed upon acceptance and rejection criteria in advance of the laboratory performing the study. Many laboratories omit or forget to include acceptance and rejection criteria; however, they are critical to ensure objectivity of when it comes to data evaluation and decision-making.
Performing Objective Validations
Clinical laboratories need to use good laboratory techniques as they perform validations. For example, laboratorians performing the validations must follow established SOPs, document protocol deviations, and blind samples. Further, labs must use good statistical technique to analyze the validation data, including resisting temptations to cherry-pick data or explain away aberrant data points. Clinical laboratories must use a high degree of discipline to perform good validation studies and data analyses.
Monitoring New Processes for Additional Risks
After implementing changes, issues not considered during risk assessment may emerge. For that reason, it is critical that CLIA laboratories monitor the processes impacted by the changes for a period of time to ensure that there are no unanticipated risks to patient safety or laboratory operations stability.
If your laboratory has questions about how to manage changes or needs assistance with performing risks assessments, planning validation activities, reach out to an experienced CAP/CLIA Laboratory Director and CLIA laboratory builder (Contact us).
Comments