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.
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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
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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