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.

Can you guess what Dr. Westgard had to say?

Posted by Sten Westgard, MS

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?

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...

Posted by Sten Westgard, MS

Laboratory Quality Control Based on Risk Management

Posted by James O. Westgard, Sten A. Westgard

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

Westgard QC is proud to announce 2 new public workshops to be held this year:

• Six Sigma Tools and Metrics, June 1st

• Risk Assessment Guidelines and QC Plans, June 2nd-3rd

Both workshops will be held at the DoubleTree Hotel in Madison, Wisconsin.

For more than a decade, the Westgard Workshops have provided in-depth training that can't be found at other conferences. If you want to be more than an anonymous seat in a cavernous hall... If you want to learn whether or not the latest management fad has any real applications in laboratories... If you want honest assessments instead of equivocal statements... If you care more about practical tools than precious theory... You need to attend the Westgard Workshops.

More details on the workshops after the jump...

Posted by Sten Westgard, MS

Earlier, we posted an article on the website with a darkly humorous take on the passing of the CLSI EP22 guideline, which voted itself out of existence in late 2010. Other websites have also noted its passing.

But it's worthwhile to take a moment to discuss, in all seriousness, where we are with Risk Information, Risk Management, "Equivalent QC", and the CLIA Final Rules. How did we get here? What drove us to this state? Where are we going next?

Posted by Sten Westgard, MS

The National Oil Spill Commission released a preliminary chapter of its report today. This is the commission charged with finding out what went wrong with the Deepwater Horizon / Macondo oil rig in the Gulf of Mexico that blew up in 2010 and spilled 4 million barrels of oil and killed 11 workers.

Whenever there are big stories in the media, we like to take a look at them to see if we can learn anything, find any connection between the disaster and our own situation in the medical laboratory community. But from a distance, it's hard to see any similarities between oil rigs and labs, right?

Right?

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

Alan Greenspan gave some instantly notorious testimony to the US Congress recently:

“I was right 70 percent of the time, but I was wrong 30 percent of the time,” 

I'm not sure what was more concerning; the fact that he admitted that almost a third of the time he was wrong, or that he clearly believes that being right only 70% of the time was acceptable. Clearly, for a man once called "The Oracle" and Maestro, he was lowering the bar on the standards for judging him.

Testimony like that raises some instant questions:

• If Alan Greenspan was responsible for setting the direction of the world's greatest economy, is a 30% error rate acceptable?
• If Alan Greenspan was an airline, would you fly him?
• If Alan Greenspan was a core laboratory test, would you buy the instrument?
• If Alan Greenspan was a glucose meter, would you buy the device?

Posted by Sten Westgard, MS

“There is increasing recognition of a need to improve the precision of HbA1c assays, in view of the low biological variability of Hb A1c. The NGSP plans to reduce the
acceptability specification for level 1 laboratories to 0.70% and for manufacturers of all Hb A1c methods to <0.75% in 2010 (http://www.ngsp.org/ ngsp/prog/News/manuf09.html; accessed October 28, 2009). The College of American Pathologists (CAP) also has recognized the need to tighten total error criteria for Hb A1c and is in the process of
revising the criteria used in grading proficiency tests (http://www.
ngsp.org/ngsp/prog/News/manuf09.html; accessed October 28, 2009). In 2007,
the limit specified by the CAP for acceptability on HbA1c proficiency testing was +/- 15% of the target value. This limit was lowered to +/-12% in 2008 and to +/-10% in 2009, and it will be lowered to +/-8% in 2010 and to +/-6% in 2011. “

As these quality requirements tighten, how are we going to respond?

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

My esteemed colleague, good friend, and keen-eyed tracker of all things regulatory. Dr. Sharon Ehrmeyer, alerted me to a HUGE change in US regulations.

In April CMS sent out a memo title "Policy Clarification on Acceptable Control Materials Used when Quality Control (QC) is Performed in Laboratories"

This memo may contain as big a shift in regulatory policy as IQCP was to EQC.  More, after the jump...