Posted by Sten Westgard, MS
Six Methods for HbA1c: are any at Six Sigma?
There have been a lot of studies on HbA1c in the journals this year. A recent study took a look at some of the major instruments for HbA1c: Bio-Rad's Variant II, the Variant II Turbo, Tosoh G8, Capillarys 2, Integra 800, DCA Vantage. The study concludes that many of these methods should run 9 controls a day. Does the Westgard Sigma-metric analysis agree?
Do our HbA1c methods fail the "fit for purpose" test?
Assessing Risk with Six Sigma: Using Sigma-Metrics to build Quality Control Plans (QCPs)
Continuing in our analysis of the HbA1c study above, Dr. Westgard dives into more details about the various approaches of assessing risk, calculating Sigma-metrics, and developing Quality Control Plans. Do we need patient-weighted Sigma-metric averages? Regular averages? Point estimates?
When laboratories make their risk assessments, should they use Sigma-metrics, something more complex, or should they just implement QCFs (quality by crossing your fingers)?
Upcoming Webinars:
For still more information on Risk Analysis and QCPs, tune into these webinars. Learn if QCPs are right for you at the POC, in the core lab, or with your LDTs. Learn whether you're ready for a Total Quality Control Plan or just an Individualized QCP. Learn how Risk Assessment can be performed not just by guesswork, but by good data.
These webinars include not only a lecture but also an extended Q&A session. If you missed previous sessions, you can still access and view them. Capacity [bandwidth] for attendance is limited. Priority is given on a first-requested, first-enrolled basis. Registration is required.
[Please note: this webinar series is sponsored by Thermo Fisher Diagnostics]
You can register for the webinar series here
Revised Rilibak Rules?
Back in 2009, we posted an unofficial English translation of the German RiliBÄK (Richtlinien der Bundesärztekammer). These quality goals were recently updated. So what's been changed? Have the allowable errors been reduced? Are there new analytes?
Here's a summary of the differences.
Here's the fully updated list: the German Goals for Quality
Ready to Prove your Quality?
Debating - or decrying - the quality of laboratory methods has been a perennial concern of the professional journals, conferences, and even the articles on this website. Finally, we've decided to do something about it: a new initiative, the Westgard Sigma Verification of Performance [TM] which gives laboratories the opportunity to prove that they have the right methods, the right staff, the right training, the right QC, and ultimately, the right test results. It's not an easy process, and it's not for everyone, but it will offer labs the chance to benchmark their performance on a global scale.
Explore the Sigma Verification of Performance [TM] program here and see labs that have already succeeded.
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