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...
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Posted by Sten Westgard, MS
Heads up. There's a new abbreviation in town: IQCP
Can you guess what IQCP means?
Information Quality Certified Professional
Individualized Quality Control Plan
Intelligent Quality Control Plan
Incoherent Quality Control Plan
Ill-conceived Quality Control Plan
The answer, after the jump...
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Posted by Sten Westgard, MS
Recently, a user submitted a question about the mandatory use of the 10x 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 10x control rule?
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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."
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