Posted by Sten Westgard, MS

I just wanted to share some pictures of a trip taken back in late April.

The Asian Society of Continuing Medical Education was kind enough to invite me to present in a workshop titled "Assuring Quality, Standardization, and Efficiency in the Laboratory 2012"  In Delhi and Mumbai.

Group picture, Mumbai

More pictures, after the jump.

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

Here's a range of statistics describing the performance of a glucose method. Try to pick: Which one has acceptable performance?

1. method with combined uncertainty 3.69%
2. method with combined uncertainty 6.79%
3. method with expanded uncertainty 7.38%
4. method with expanded uncertainty 13.58%
5. method with 3.78 Sigma

Which method would you pick?

Posted by Sten Westgard, MS

Recently, the journal In Vitro Diagnostics Global News a publication of CGI KK and in association with CAP Today, has begun publishing a series of translations of Westgard articles into Japanese:

The title of the series is Think QC Again, an important message regardless of language or country.

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

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

In the recent issue of Clinical Chemistry, an editorial reviews the current state of Vitamin D testing: "There is common agreement that 25-OHD is a 'difficult' analyte."

25-Hydroxyvitamin D: A Difficult Analyte, Graham D. Carter, Clin Chem 58:3; 486-488 (2012).

At the same time, the editorial notes that marked process is being made:

"Nevertheless, results submitted to the international Vitamin D External Quality Assessment (DEQAS) have shown a gradual reduction in interlaboratory imprecision (CV) in recent years - from >30% in 1995 to 15% in 2011."

The question is, is that reduction in imprecision good enough? Or is the quality required by Vitamin D still too "difficult"?

More after the jump...

Posted by Sten Westgard, MS

Heads up. There's a new abbreviation in town: IQCP

Can you guess what IQCP means?

1. Information Quality Certified Professional
2. Individualized Quality Control Plan
3. Intelligent Quality Control Plan
4. Incoherent Quality Control Plan
5. Ill-conceived Quality Control Plan

The answer, after the jump...

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

Recently, a user submitted a question about the mandatory use of the 10_x rule on chemistry analytes as mandated by ISO 15189 through NABL:

"Specific criteria of accreditation of NABL India (for ISO 15189) say that 10x should be considered as a violation for clinical chemistry  and Immunoassay parameters. However we understand that Westgard rules consider it as a warning only. Please advise."

So, the central question is, does ISO 15189 mandate the use of the 10_x control rule?

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

Posted by Sten Westgard, MS

In the December 2011 issue of Point of Care journal, an interesting study was published:

Preanalytical Errors in Point-of-Care Testing: Auditing Error of Patient Identification in the Use of Blood Gas Analyzers, Natalie A Smith, David G Housley, Danielle B. Freedman, Point of Care, Volume 10: Number 4, December 2011.

The study looked at patient identification errors on a blood gas analyzer in various departments in a hospital. Bearing in mind that this is just one type of pre-analytical error, what do you think the rate was? Given around 100,000 tests, what would you guess as the number of defects?