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-cen...

We got a lot of questions during our Cut Your QC webinar, too many to answer during the session. So here's one that we didn't get to "In the evening I run one level of QC and it fails 1:2s. Do I need to rerun?" This is a curious question. QC results are not different depending on the time of day. A 1:2s in the morning is the same as a 1:2s at night...

As we prepare for our Cutting Your QC webinar, we've gotten nearly two thousand registrations, along with a lot of questions. https://us02web.zoom.us/webinar/register/WN_F5IRlqySRR6eRcrm9Zz9mQ The most common question we're getting is, What does "Cut your QC" mean? I believe this comes from a perspective of many labs, that QC cannot be reduced...

Over the past few months, I've gained a bit of a reputation as a LinkedIn grouch. When I come across posts here that describe the Westgard Rules, analytical Sigma metrics, QC in general, I am quite direct about pointing out errors. In the flood of AI-generated images and flyers, there is currently an overwhelming trend to get things wrong. Over the...

More than 600 of your laboratory peers are already registered for Cut Your QC. https://us02web.zoom.us/webinar/register/WN_F5IRlqySRR6eRcrm9Zz9mQ Now there are some qualifiers, of course. Not every lab nor every instrument is going to be able to reduce QC. A badly engineered instrument. Or a poorly maintained and deteriorating instrument. Or a poor...

An Indonesian study in Diagnostics attempted to make a comparison between Siemens and Roche instrumentation using Peer Group Sigma metrics. Out of 30 assays, Roche won 29 of 30. I can't say I wholeheartedly agree with the methodology of the study: peer group data can obscure what individual laboratories experience. The details can get lost in ...

Like many authors, I keep track of where I'm cited. So I was a bit surprised to see I had been referenced in a paper in the Agricultural Association of Textile Chemical and Critical Reviews Journal: https://doi.org/10.21276/AATCCReview.2026.14.03.22 Not the usual journal I expect. But even more curious, the title of the paper is "An overview of qua...

After premiering this event at ADLM, we are opening it up to everyone through zoom. Please join us September 25th, at 11 am central standard time. At last, a frank look at why we need to do less QC, and how we can make those reductions safely.  If you enjoy being out of control every day, if you get a thrill every time you have to repeat a con...

"I have a question about establishing a Levey-Jennings control chart. laboratories should collect a minimum of 20 measurements over at least 10 days to calculate the mean and SD for the chart. My question is: Is it required that these initial 20 data points must fall within the manufacturer's declared range (or assigned values) for the control...

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...

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...

The term "enshittification" is having a moment right now. It was coined in 2022 by the author/essayist Cory Doctorow, and named the 2023 and 2024 word of the year by the American Dialect Society  and the Macquarie Dictionary, but the publication of the eponymous book is bringing it to the fore. Enshittification is a on...

We're still working through questions that came up in our Global QC Survey results webinar. Question: What's your advice to labs new to Sigma metrics? How to gradually transition? We're at an interesting time in the evolution of analytical Six Sigma metrics. Many of the major control vendors have built analytical Sigma metric calculations righ...