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Tools, Technologies and Training for Healthcare Laboratories

Q & A: We don't run QC with a time machine
Sten Westgard
Uncategorized
A question came in about running QC and looking at the initial 20 data points used for validation. Full Question: "I want to ask: when running in parallel, the first 20 data points don't have Westgard rules applied, and the data is within the manufacturer's 2SD limit. "However, once the laboratory mean/SD is calculated and the laboratory&...
Q: What if we can't Westgard Sigma Rules?
Sten Westgard
Uncategorized
Another Question from the "Cut Your QC" webinar: "If management is unwilling to adopt the Sigma-metric method, is there a better Westgard Rule than 1:2s to apply across the board to all analytes?" If Westgard Sigma Rules aren't a possibility at your laboratory, there are still better ways to run QC using the 1:2s rule. Remember, with 2 controls, th...
Q: For every method, instrument, reagent lot, a new QC rule?
Sten Westgard
Uncategorized
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...
10 of 27 analytes on a Cobas Pure cannot hit desirable MAU
Sten Westgard
Uncategorized
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...
Where do all the errors happen?
Sten Westgard
Uncategorized
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...
Q: Can POC Cut their QC?
Sten Westgard
Uncategorized
"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...
Q: 1 level is out 3 sd, but the other 2 levels are "in", what do we do?
Sten Westgard
Uncategorized
"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  ]...
Q: Should we change our 2 SD manufacturer range to a 3 SD manufacturer range?
Sten Westgard
Uncategorized
"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...
Q: Will my staff get confused and frustrated by Westgard Sigma Rules?
Sten Westgard
Uncategorized
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 ...
Q: If controls are unstable, can they be trusted?
Sten Westgard
Uncategorized
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...

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