Another timely question from our Cut Your QC webinar 9/25/26:
"What model can be used with planning QC based on the clinical risk to the patient, as considered ISO 15189? One of the challenges lies in selecting quality specifications – specifically, how to determine whether the approach is too lax or too strict."
Risk-driven, Risk-focused, Risk-centered thinking is definitely on trend right now. ISO 15189 and ISO 9001 both place risk at the center of efforts. What does analytical quality planning have to do with clinical risk?
The existing Milan Hierarchy recognizes 3 models, 1. Clinical use. 2. Biological variation. 3. State of the art. Note that none of the three explicitly mention risk. But it can be argued that the Model 1 must take into account clinical risk. Model 1 is the most likely approach that aligns with the new risk focus of ISO standards. The unfortunate truth is that most labs do not have goals that adhere to Model 1 principles. It's far more likely that labs are using SOTA goals, because they are readily available and by definition easier to achieve.
So the new new Risk doesn't preclude Cutting your QC. But it may be harder to do so if the Risk-driven goals are tighter than biological variation or state of the art goals.