Posted by Sten Westgard, MS
The second and third days of the Westgard Workshops 2011 focused on Six Sigma Risk Analysis - quantiative, data-driven Risk Management. CLSI will soon be issuing official guidelines on Risk Analysis for QC (the proposed version of EP23 is available, but the final accepted version is not. The CLSI EP23 guideline is expected to be approved by the end of the summer). But there's no need to wait for CLSI to do Risk Analysis. There are many existing resources for laboratories to utilize and start right now.
Tina Krenc, an expert in FMEA (Failure Mode and Effects Analysis), leads a group activity on the use of FMEA for laboratory processes
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Posted by Sten Westgard, MS
The Westgard Workshops 2011 were held in Madison, Wisconsin last week, June 1st through 3rd.
Dr. Westgard discusses a question with participants
The topic for the first day was Six Sigma Metrics and Tools. Six Sigma is well known even in healthcare. We did our first Six Sigma workshop about a decade ago. But some of the calculations and implications of Sigma-metrics, particularly for analytical performance, remain less well known. We covered not only the calculations but also the outcomes - how it can improve QC, reduce repeats, increase error detection, and provide better reporting advice to clinicians.
But even beyond these benefits of Sigma-metrics, there's a simple advantage to using the Sigma scale when discussing errors.
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Posted by Sten Westgard, MS
We live in an era of diminished resources, particularly in healthcare, particularly in the laboratory, and particularly for education and training. The training budgets for labs have been shrinking and shrinking over the years, even as the need for skilled technologists has increased.
Educational institutions have not been able to provide enough (high quality, lost cost) training to fill the need. So the manufacturers and vendors have stepped into this gap, supporting the educational needs of their customers.
Westgard Workshops 2011 could not have been mounted without the generous educational help of our gold sponsors, Bio-Rad Laboratories and Abbott Diagnostics. Randox Laboratories also stepped up and provided a premier sponsorship, which helped us immensely.
Dr. James Westgard, pictured here with representatives of the Premier Workshop Sponsor, Randox Laboratories. At Left, Vinay Naik, National Account Manager, who introduced the workshops. Also pictured here is Lynsey Adams, Scientific Writer.
After the break, you can hear the Westgard Workshops Introduction from Randox...
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Posted by Sten Westgard, MS
An interesting question came in through email (we always want to hear from you!):
"1. Can we apply Westgard multirules to hematology control?
2. I read in one paper that the hematology control range is calculated as mean +/- 2.5 SD, is this correct and if not how can I calculate own laboratory hematology control range?"
The answer, after the jump...
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Posted by Sten Westgard, MS
We got an excellent question the other day via email:
I have heard the term "Within QC" and "Across QC"used, but what do these refer to specifically andwhere can I find more information about what ismeant by those terms? I was not able to find thisinformation, but laboratory leadership staff saidthat "Within QC" referred to assessing multi-rules"within QC level and across QC runs", and that"Across Qc" referred to assessing multi-rules"looking at both QC levels, can be within same runor back-to-back runs".A lab has the following multi-rules; "Within QC"1:3s, 1 QC result outside 3sd; 2:2s, 2 consecutiveQC results outside 2sd on the same side of the mean;4s, 2 consecutive Qc results differ by more than4sd; and 1:2s, 1 Qc result outside 2sd and within 3.(1:2s is used as a warning rule, the others asrejection rules). The rules for "Across Qc" are asfollows; 2:2s, 2 consecutive Qc results (1 eachmultiple levels) are outside of 2sd; and 4s, 2 Qcresults (one of each multiple levels) are >4sdapart. These are both rejection rules. Thesemulti-rules are used to assess all tests in achemistry lab; the majority of tests are assessedwith 2 levels of Qc, a few use 3 levels of Qc.The situation arose where QC results on one day fora cancer antigen were the following:Day 1A:Level 1 -Within 2sd, acceptableLevel 2 -1:2s, run was accepted as only the warningrule 1:2s was encountered.The next day the results were as follows:Day 2A:Level 1 -1:2sLevel 2 -Within 2sdLeadership said run should not be accepted,violating the "across" 2:2s rule.However, leadership said the inverse situation wouldhave been acceptable as *consecutive* data pointsdid not violate the "across" 2:2s rule, i.e.
Day 1B:Level 1 1:2sLevel 2 within 2sdDay 2B:Level 1 within 2sdLevel 2 1:2sIn the A group, because Level 2 is outside of 2s,and the very next data point (Level 1 from the nextday) is also out 2s, the run is unacceptable andshould be rejected. In Group B, since consecutivedata points are okay the run is acceptable.Is this a correct approach? Is it correct to rejectgroup A (Day 1A and 2A) and not reject group B (Day1B and 2B)? Do these multi-rules as outlined andimplemented detect some unacceptable variation ingroup A that does not exist in group B? Thank youfor any clarification.
So what's the answer? Are scenarios A and B fundamentally different? More after the jump.
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