Posted by Sten Westgard, MS
It's that time of year again, where the usual and not-so-usual suspects of the laboratory world gather and discuss science - mixed in with a healthy dose of commerce. We have just returned (and are still recovering from) the annual AACC/ASCLS meeting in Atlanta, Georgia.
James O. Westgard at the Westgard QC booth for the 2011 AACC/ASCLS exhibition
More pictures and details of the convention after the jump...
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Posted by Sten Westgard, MS
The second and third days of the Westgard Workshops 2011 focused on Six Sigma Risk Analysis - quantiative, data-driven Risk Management. CLSI will soon be issuing official guidelines on Risk Analysis for QC (the proposed version of EP23 is available, but the final accepted version is not. The CLSI EP23 guideline is expected to be approved by the end of the summer). But there's no need to wait for CLSI to do Risk Analysis. There are many existing resources for laboratories to utilize and start right now.
Tina Krenc, an expert in FMEA (Failure Mode and Effects Analysis), leads a group activity on the use of FMEA for laboratory processes
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Posted by Sten Westgard, MS
There was some very interesting testimony given in front of the US Congress this week. Boeing and other FAA officials discussed their failure to adequately test the lithium-ion batteries found in the 787 Dreamliner. As you probably already know, on two of the Dreamliners, those batteries malfunctioned and caused fires, which then caused the entire fleet to be grounded.
In the New York Times, it was reported "Boeing’s chief engineer on the 787, Mike Sinnett, said the calculation that a battery would fail only once every 10 million flight hours applied to the design of the battery and did not include possible manufacturing flaws."
In fact, two battery failures and serious fires occurred after less than 52,000 flight hours. The risk was actually over 350 times higher than their estimate!
How could they be so wrong? More after the jump...
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Posted by Sten Westgard, MS
The biggest news coming out of the AACC/ASCLS conference in Houston was made by Judy Yost of CMS.
So the new future is IQCP. Remember what that stands for?
- It's Quickly Coming to Pass
- I've Quit Caring about Performance
- It's Quackery, Chaos, and Pablum
- I'm Quietly Compromising my Processes
Posted by Sten Westgard, MS
On August 16th of this year, CMS issued a new memo about IQCPs. If you recall, IQCP stands for Individualized Quality Control Plan, and it's part of the new Risk QC being proposed by CMS as a replacement for EQC. The CLSI guideline EP23, which came out about two years ago, laid out the broad outlines of this new policy, but we have been waiting for the government regulations to spell out the specifics of implementation and interpretation.
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS [with apologies in advance*]
Take the "Low QC" Quiz to see if your laboratory is suffering from this new condition...
- Do you have a decrease in your desire to QC?
- Do you have a general lack of energy at work caused by QC?
- Have you noticed a decrease in your enjoyment of life, possibly due to QC?
- Are you sad and/or grumpy about QC?
- Has there been a recent deterioration in your ability to trouble-shoot QC?
Answers, after the jump...
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Posted by Sten Westgard, MS
As many of you know, EQC is out and IQCP is in. As the expiration date for EQC approaches in 2016, labs need to learn more ab
out Risk QC and IQCPs. CMS has an email address where you can send questions.
We tried out the question and answer line with CMS, see the results after the jump...
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Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
While traveling in the middle east recently, I was asked by a colleague about the new US IQCP regulations, specifically how to implement them in their foreign laboratory.
Frankly, I was a bit shocked. I didn't realize that anyone outside the US was paying attention to the IQCP roll-out.
But it does raise a good question: Is IQCP a global necessity? Or merely a US idiosyncrasy?
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Posted by Sten Westgard, MS
With sincere thanks to Carolyn Maurer, the Director of the CAP 15189 program.
As the new IQCP regulations kick in, it's been interesting to see the international reaction to them.
I admit that I thought the IQCP impact would be contained within the US, that contagion would not spread to the international community. After all, IQCP is only a required option for labs within the US, and then only required for labs that seek to find a replacement to their now-outdated EQC policies. For labs that don't want to reduce their QC frequency below once a day, there's no need to create an IQCP at all.
But the situation appears to be more complicated. CAP, which has a significant international presence, is rolling out IQCP to all of its members, not just its US customers.
In light of that, I asked CAP how it balances the IQCP reduced QC frequency with the ISO 15189 standards. Their answers, after the jump...
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Posted by Sten Westgard, MS