WESTGARD QC

Are you aware of "becoming aware"? As we hurdle toward the first implementation stage of LDT regulation, reporting becomes paramount. But _when_ are you required to report? Once you "become aware," which has a specific regulatory definition: "(b) Become aware means that an employee of the entity required to report has acquired information that reasonably suggests a reportable adverse event has occurred. "(1) If you are a device user facility, you are considered to have 'become aware' when medical personnel, as defined in this section, who are employed by or otherwise formally affiliated with your facility, obtain information about a reportable event. "(2) If you are a manufacturer, you are considered to have become aware of an event when any of your employees becomes aware of a reportable event that is required to be reported within 30 calendar days or that is required to be reported within 5 work days because we had requested reports in accordance with § 803.53(b). You are also considered to have become aware of an event when any of your employees with management or supervisory responsibilities over persons with regulatory, scientific, or technical responsibilities, or whose duties relate to the collection and reporting of adverse events, becomes aware, from any information, including any trend analysis, that a reportable MDR event or events necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health." Source: https://lnkd.in/g3wSNau2 Remember, labs are now manufacturers of LDT tests, so whenever _anyone_ of your employees becomes aware, you've become aware, too. You may even be aware right now and not know it! So now you're aware of becoming aware. #ldtmadness #ldt #westgardrules

Fun pull quotes from the LDT regulation, #1: "Performing well during proficiency testing does not mean that a test is analytically and clinically valid." When we apply this to existing "traditional" methods (not LDTs), on one hand, I agree that passing PT (where a 20% failure rate is acceptable) does not equal excellent performance. On the other hand, one hopes that the method got examined and vetted and tested earlier than PT. If the method made it all the way to getting included in commercial PT surveys, those analytically and clinically valid steps should have happened far further upstream. [Ah, who am I kidding? Even outside the LDT world, there are analytically invalid methods on the market for many tests. Analytical validity isn't strongly enforced in the normal testing world (see 510ks), much less the LDT world.] https://lnkd.in/ezFPjf66 #LDTmadness

"[P]remarket review is one of FDA's most important tools for protecting and promoting public health. Through premarket review, the Agency evaluates the scientific information supporting the analytical validity, clinical validity, and safety of high- and moderate-risk IVDs, which helps ensure the IVD's safety and effectiveness before it reaches a patient." The key term, analytical validity, is about to have a LOT of impact on US laboratories. Now that labs are manufacturers, they will have to prove analytical validity. Which has an overlap with Method Validation (but not Method Verification), and yet will require still more work by the lab. 2025 is going to be a fun year. https://lnkd.in/ezFPjf66

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Those who don't learn from QC are condemned to repeat it.

AI gets it wrong... again. Ask and you shall be confused. The AI scraper has all the right ingredients, but no ability to understand what is the actual goal. AI has no laboratory knowledge, cannot look at the numbers and make sense of them. But it can regurgitate them and confused you even worse. On this #CLINICAL24 day, I advise you not to let the shiny new tools bedazzle you. If you design something new without skills or insight at the start, there's no magical way to gain it on the way. More likely, you'll find that you've found an answer that is popular... and wrong. #westgardrules

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From the annals of AI errors... When you ask Google what the CLIA goal for T3 uptake, they give you the WRONG answer. It's not 18% OR 3 SD. It's just 18%. 3 SD is the old goal that is being abandoned. If you see the source material that Google's AI scraped, chewed and then regurgitated, you can see why the error was made. https://lnkd.in/e3pcEvMr But because AI is essentially an unthinking idiot, there is really no way to double-check what its spits back out. AI is not generative, its regurgitative. It serves up warmed over vomit. The algorithm's only goal is to make the vomit look real. Despite that, we're all going the way of AI, and we've just decided to accept these errors. Sigh.

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