Every so often reality delivers a vicious refute to the myth of continuous forward progress. While we often assume (and hope) that the arc of the universe bends towards justice, progress, unity, and peace, it is never safe to take for granted that civilizations will always choose to take a step forward. There is always a very real possibility that countries and societies will choose instead to take a step backward.
Are Sigma-metrics immune from manipulation? Of course not. If you're dealing with a manufacturer who is willing to skirt the truth about their instrument performance, it should hardly be surprising that they find ways to "boost" their Sigma-metric performance. A recent white paper provides an example of how manufacturers might mislead you - and therefore alerts us to the safeguards we need to insist upon when we analyze performance data.
The Theranos Scandal is an object lesson for the laboratory industry. It's not only an example of what NOT to do, but also an example of what we risk when we don't demand proof of quality, or what we might suffer if we don't prove the quality we're delivering. We don't want to be Theranosed. And we certainly don't want to be Theranosing others...
In May 2016, the International Journal of Laboratory Hematology published a set of State of the Art performance specifications for hematology parameters. How close is state of the art to the other goals specified by Ricos, CLIA, Rilibak and others? See here.
There are days I worry we are debating how many angels can dance on the head of a performance specification. Or that we're all blind men feeling different parts of a great elephant of error and uncertainty. But the latest "round" in the debate is depressingly familiar.
Innovative Diagnostics has become the first (and fastest) private laboratory in Singapore to achieve the Verification of Performance. (Sigma VP). More than 45 analytes, including chemistry, immunoassay, hormones and tumor markers on multiple instruments.
Winchester Hospital of the Valley Health System has summarized the IQCP information from multiple resources and distilled it down to a short primer. Perhaps these are the plans you're looking for.