Q: "You mentioned that there can be variation in performance even with different reagent lots. Are you recommending that we change QC rules based on the performance of each lot on each instrument?" This is another question from our Cut Your QC webinar, now available as an on-demand recording. https://us02web.zoom.us/webinar/register/WN_F5IRlqySRR6e...
I came across a rare but intriguing study of measurement uncertainty recently:Standardized Estimation of Measurement Uncertainty in Clinical Chemistry Using ISO 20914. Mohammad I. Ahmad, Fayha S Ahmed, Deepa Rao, Mohamedi Begum, Sheifa Joan. Clin Lab 2026;72:1-6. https://www.clin-lab-publications.com/article/5788The study looked at 27 general bioch...
I read a recent paper on errors across the Total Testing Process (TTP) recently. It's a unique paper, one that delved into the types of non-conformances. Evaluation of Non Conformances in the Total Testing Process of a NABL-accredited Clinical Biochemistry Laboraotry: An Observational Study. Dharmikkumar Savjibhai Patel, Harshkumar Darj...
"Can this approach [Cut Your QC] be used on QC for Point of Care devices? Are rules built into these devices that can't be modified like standard central lab instruments?"This is another question from our Cut Your QC webinar, now available as an on-demand recording. https://us02web.zoom.us/webinar/register/WN_F5IRlqySRR6eRcrm9Zz9mQThe questioner sa...
"We have a 1:3s rule to reject on one level, but 2 other levels are within 1 SD. Staff is just repeating the 1:3s. Is that the right approach? Also, do you apply rules across materials?" [Another question from the Cut Your QC webinar, now available as an on-demand recording: https://us02web.zoom.us/webinar/register/WN_F5IRlqySRR6eRcrm9Zz9mQ ]...
"What is the solution if the quality control comes with 2 SD, do we need to change the product to a 3 SD control?" Another question from our Cut Your QC webinar, still available on demand at https://us02web.zoom.us/webinar/register/WN_F5IRlqySRR6eRcrm9Zz9mQ I believe this question is referring to the range that comes with the control. The manufactu...
Another question from the Cut Your QC webinar: "Most of my staff are generalists. It can be difficult for them to keep up with all of the details in every department. If we use different QC rules on each assay and instrument, how do we manage their frustration and confusion?" I get it. The prospect of every assay having a different set of QC rules ...
A follow-up question to one of the earlier Q&As: "If multiple laboratories observe a stability-related drift in a control material before the end of the manufacturer's claimed shelf life, shouldn't this trigger a reassessment of both the assigned target values and the validated stability claims by the manufacturer? "From my perspective, if real...
Another question from the Cut Your QC webinar in September: "How do we account for issues with the controls themselves (i.e. real life stability is shorter than manufacturer's recommendation)?" Of course, this is the nightmare of the QC professional: if the controls introduce more variability, the signals from QC are not completely reflective of th...
Another question that came up in our Cut Your QC webinar last month: "If a lab is repeating QC until the QC "passes", must all the out-of-control QC be recorded in the LIS? Should they be marked as accepted or rejected?" If you take an action during troubleshooting, or during any step of your laboratory operations, you should record it. To selectiv...