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
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
Posted by Sten Westgard, MS
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a required option for labs within the US, and then only required for labs that seek to find a replacement to their now-outdated EQC policies.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
Now that the age of the IQCP is here, laboratories are grappling with the time and effort it takes to build their Individualized Quality Control Plans. How long should it take to build an appropriate IQCP?
- 40+ hours
- 21-40 hours
- 11-20 hours
- 5-10 hours
- Less than 5 hours?
How much time has it taken for you? How much time do you think it should take?
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Posted by Sten Westgard, MS
Another shoe has dropped in the regulatory world. Recently, CDC/CMS issued their "how-to" guide for IQCPs, CAP dropped their checklist for IQCPs, and now the other major deemed accreditor has put out their IQCP guidelines: The Joint Commission.
So what is JCI doing about IQCPs? Join us after the jump
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Posted by Sten Westgard, MS
We knew that the accreditation agencies needed to develop their own policies to handle the new CMS IQCP regulations. CAP gets the prize for being first out of the gate with some practical steps, as well retaining some safeguards for quality.
IQCP, if it's not already burned into your head, stands for Individualized Quality Control Plan, and this is supposed to be the replacement for the EQC policies which have been in place for several years. The EQC policies are being replaced, you may recall, because they are scientifically untenable. It was hoped that IQCP was going to be more scientifically robust. That remains to be seen. CAP is attempting to assure that it will implement the CMS IQCP regulations but also provide a higher level of quality assurance than that low bar.
More after the jump.
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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
Posted by Sten Westgard, MS
Dr. Westgard talks about the new era of QC at the Thermo Fisher workshop.
Posted by Sten Westgard, MS
Earlier this month (July) I came across a series of revealing posts on a listserv about the quality of glucose meters. For me, it raised the question, just what defect rate is acceptable at the point of care?
- 0.00034%
- 1%
- 5%
- 10%
- 40%
- 75%
- 100%
What level of defect rate do you believe is being seen at the point of care? the answer (after the jump) might astonish you...
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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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