Posted by Sten Westgard, MS
As we wait for more details about EP23 and how CMS and CLIA will actually enforce the implementation of Risk QC, the latest morsels to emerge are quite tantalizing.
On the CLSI website, a Q&A has been posted. Here is one interesting bit:
"3. Is there a planned format for documenting the EP23 QCP to present to surveyors?
There is no specific format that is required for the presentation of a QCP. The example in EP23 and those currently being drafted for future education will present some options, but laboratory directors have flexibility in the formatting of their QCPs. There may be some elements, components, or data that the Centers for Medicare & Medicaid Services (CMS) will look for when assessing compliance, but nothing standard."
This is an interesting question and an even more intriguing answer. The new standard will have "nothing standard" about its implementation. Presumably labs that use the workbooks sold by CLSI will be able to fulfill any requirements for proper design of Individual QC Plans.
So why won't there be a standard QC Plan format?
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Posted by Sten Westgard, MS
As many of you know, the FDA has issued new draft guidelines about Blood Glucose Monitoring Test Systems for Industry and Manufacturers.
Recently, the AACC held an excellent webinar where an Dr. Courtney Lias, PhD from the FDA discussed the intentions of the new guidances and then fielded a LOT of questions. I don't want to step on what Dr. Lias and the AACC accomplished during their webinar. There was useful information in that presentation and I encourage others to consider getting those materials once they become available on the AACC website.
However, while reading through the guidances and talking to laboratories these past few months, I thought I might share a few observations...
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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 [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
Posted by Sten Westgard, MS
Laboratories in the US probably already know this: their healthcare institutions are getting hit with fines from CMS due to excessive 30-day readmission rates for three conditions:
- (AMI) Acute myocardial infarction
- (HF) Heart Failure
- Pneumonia patients
CMS is imposing increasing fines for hospitals that have excessive readmissions. Guess how many hospitals have been fined - and how much money they've had to pay back...
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Posted by Sten Westgard, MS
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
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
Dr. Westgard had the pleasure of taking part in the Bio-Rad industry workshop on July 17th, which was focused on Quality Control for the Future - Risk Management EP23 for Laboratories.
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Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
So we all know that Risk Analysis is coming to laboratories in the US. (click here if this is news to you). But Risk Analysis, particularly the FMEA technique (Failure Mode and Effects Analysis), is not new to healthcare. Outside the laboratory, plenty of healthcare practitioners have been performing FMEA.
So what do they think about this technique? Try and guess which one of these responses is from a someone in healthcare:
- "The jury's still out on the FMEA process because... has anybody evaluated FMEA as a tool for analysing risk? And it turns out there isn't... well why are we doing this process?... When all it is doing is bringing a few things to the surface, which is no bad thing, but it's not a validated process."
- "...Forget FMEA. It doesn't really work effectively, I don't think, and the scores are a hindrance rather than anything else, year... We wasted a lot of time on FMEA before we realized, this isn't actually working. Yeah, because I think you can get caught up on just the score, that's the thing."
- "The scoring in the FMEA teams need to be the same people, if you change half way through because of the highly subjective interpretation things change dramatically."
Posted by Sten Westgard, MS
Now that we know EQC will officially be phased out and instead Labs will have to develop QC Plans through Risk Analysis (as explained in CLSI's new guideline EP23A), some of the waiting is over. EQC, which was fatally flawed from the start, is going to go away.
However, the exact regulations about QC Plans and Risk Analysis have yet to be written (or, at least, are not yet known by the general public). What makes this more uncertain is that EP23A is only meant as a guideline, and the Risk Analysis approach discussed in the guideline is only meant as a possible example. Risk Analysis is a long-established technique (outside the medical laboratory) and has many different formats and levels of complexity. Even between EP18 and EP23, there are discrepancies between the Risk Analysis recommendations (EP18 recommends a 4-category ranking of risk, while EP23 recommends a 5-category approach).
So while we're waiting for the other shoe to drop (in the form of detailed regulations and accreditation guidelines governing Risk Analysis), we might as well talk about what questions those rules will have to answer...
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Posted by Sten Westgard, MS