Every so often it's useful to transpose a few practices from outside the laboratory into the laboratory, just to see how we would evaluate them. The new Tech powers are gleefully implementing a system called "surveillance pricing", which they sell as a dynamic way to sell things to customers, except it turns out that they really only want the prici...
The fallout of the IDVR continues. An interesting quote from a recent paper: "Although the EC aimed at bringing safe and effective medical tests to the EU-market, ~9,000 tests out of ~40,000 tests got lost in transition." Nearly a quarter of tests suddenly became unacceptable? That places IVDR at just above 2.2 Sigma. The proposed soluti...
A paper from Surabaya, Indonesia assessed the performance of an anonymous hematology analyzer. The study used the old CLIA 1992 goals. We updated it with an assessment using CLIA 2025 goals. And then it became clear why this instrument was not named. None of this performance would meet CLIA's standards. Is performance so bad in this analyzer, ...
This question recently came in: "We have two specific questions regarding the practical application of the 7T rule: "When applying this rule, is it mandatory to use the 1:2s rule as a starting trigger, or can the laboratory choose to use 7T independently without the 1:2s initiation? (Personally, I believe 1:2s initiation is necessary….) "When a 7T ...
The Westgard Rules, in the classic 1981 multirule paper, require a 1:2s violation before other rejection rules are violated. If you had4 values past 1s, but nothing past 2s, it wouldn't be checked. Under more "modern" Westgard Rules, with the 1:2s warning rule abolished, you don't need to wait until the 2s limit line is violated before interp...
A recent question popped up in one of our recent webinars: "It seems to me that repeating a QC may or may not have value, yes if it provides further troubleshooting data, and not if it is used to override a proper error flag. But to group the two together, without making that distinction seems inappropriate. Perhaps expand the survey ques...
A recent question came to me via social media: "Hello Sir, Good morning, How are you? I wanted to know is still 10x rule is coumpulsary?[stet.] Even [when] we are using lab mean and lab SD. Please share the details.Thanks and Regards, [anonymous]"10:x is not compulsory by any regulation that I am aware of. Many regulations require you to...
[Full disclosure, Westgard QC has a partnership with Beckman Coulter. However, this paper was not prepared by Westgard, but was written completely independently. We are simply calling attention to the study's unique approach and findings.] A new study from Tamil Nadu, India, has gone into unprecedented detail of the analytical performance. Typicall...
A significant new paper just became available online, tackling the difficult challenge of CGM quality: Clinical assessment and acceptance criteria for continuous glucose monitoring (CGM) system performance: A proposed guideline by the IFCC Working Group on CGM, Pleus S, Eichenlaub M, Dabla PK, Diem P, Boija EE, Fokkert M, Hinzmann R, Jendle J, Klon...
Interesting study published recently in the October 2025 issue of Philippine Journal of Pathology: Mark Angelo Ang, Karen Cybelle Sotalbo, Quantifying Total Allowable Error Violations in Serum-Sodium Quality Control: A Computer Simulation Experiment of Two- to Six-Sigma Processes, October 2025, Philippine Journal of Pathology 10(2), DOI: 10.21141/P...