Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
[Hat-tip to the AACC Point-of-Care listserve, which first posted a notice about this article]
The Pennsylvania Patient Safety Advisory has a regular electronic newsletter highlighting new science and studies about healthcare safety. Their December 2011 issue has a particularly interesting article for laboratory testing:
Point-of-Care Technology: Glucose Meter's Role in Patient Care, Lea Anne Gardner, PhD, RN, Senior Patient Safety Analyst, Pennsylvania Patient Safety Authority.
This review examined more than 1,300 reports of glucose-meter problems from the Pennsyvlania reporting system database from 2004 to 2011. Of those reports, 71 near-miss or adverse event reports occurred. Most intriguing are the report excerpts directly quoted in the study. Of those reports, 72% of the near-miss or adverse events occurred with high-blood glucose results. That is, where the glucose meter had a sudden high value that may or may not have been reflective of the actual patient's clinical state. For example:
"A patient's blood sugar was checked using a [glucose meter]. The lunchtime result was 517. A [blood glucose test] was [immediately] retaken to check for accuracy, and the result was greater than 600. A blood [laboratory] test was conducted per protocol, and the [lab] glucose [result] was 136..."
What do you think happened next?
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Posted by Sten Westgard, MS
Now that we know EQC will officially be phased out and instead Labs will have to develop QC Plans through Risk Analysis (as explained in CLSI's new guideline EP23A), some of the waiting is over. EQC, which was fatally flawed from the start, is going to go away.
However, the exact regulations about QC Plans and Risk Analysis have yet to be written (or, at least, are not yet known by the general public). What makes this more uncertain is that EP23A is only meant as a guideline, and the Risk Analysis approach discussed in the guideline is only meant as a possible example. Risk Analysis is a long-established technique (outside the medical laboratory) and has many different formats and levels of complexity. Even between EP18 and EP23, there are discrepancies between the Risk Analysis recommendations (EP18 recommends a 4-category ranking of risk, while EP23 recommends a 5-category approach).
So while we're waiting for the other shoe to drop (in the form of detailed regulations and accreditation guidelines governing Risk Analysis), we might as well talk about what questions those rules will have to answer...
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Posted by Sten Westgard, MS<
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Here's an eye-opening report from the Office of Inspector General from the Department of Health and Human Services: Adverse Events in Hospitals: National Incidence Among Medicare Beneficiaries
So what's your best guess on the frequency of adverse events?
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Posted by Sten Westgard, MS
A recent Clinical Laboratory Strategies article:Anchoring POC Quality in Clinical Decision-Making and the related study: Novel analysis of clinically relevant diagnostic errors in point-of-care devices, KM Shermock, MB Streiff, BL Pinto, P Kraus, an dPJ Pronovost, (J Thromb Haemost 2011;9:1769-1775) have an interesting observation about the use of the correlation coefficient to accept method performance.
They looked at Hemochron POC devices, analyzing 1518 paired INRs. The correlation between the POC and laboratory measurements ranged between 0.84 and 0.91.
The authors stated, "Traditional, quarterly, quality assurance studies emphasize correlation analysis." So this study has good news, right?
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Posted by Sten Westgard, MS
Why do some numbers and statistics in the laboratory attract more attention than others?
While we consider ourselves scientists who make decisions based on rational cost-benefit analyses, an objective look at some of our priorities often reveals the opposite. Labs often make decisions and set priorities based on the emotions of the moment, rather than a cold analysis of the data.
Let's put it another way. There is an infamous quotation attributed to Stalin: "When one man dies it is a tragedy, when thousands die it's statistics."
Do labs respond more to individual tragedies or their own statistics?
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Laboratory Quality Control Based on Risk Management
Posted by James O. Westgard, Sten A. Westgard
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
One more shot at error rates! At the IFCC Berlin conference, there was an intriguing abstract about the use of Quality Design/Planning tools in the laboratory:
Abstract #1062: Efficiency of Analytical Qualit yControl with Various Quality Planning Tools in Thai Clinical Laboratory. K. Sirisali, S. Manochiopinj, S. Sirisali.
How high do you think out-of-control rates can go?
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Posted by Sten Westgard, MS
Earlier we discussed error rate issues at the Point-of-Care. But we didn't want to leave the "regular" laboratory out of the fun, so here's a study of error rates that came out in 2010:
Evaluation of errors in a clinical laboratory: a one-year experience, Goswami B, Singh B, Chawla R, Mallika V, CCLM 2010;48(1):63-66.
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A new study in Clinical Chemistry investigated the errors rates for Point-of-Care (POC) devices:
Can you guess what the error rates were?
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Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
[This picture is actually from Curitiba, Brazil, the SBAC conference back in late June, at a lecture I gave there on Sigma-metrics. I don't have a picture of my lecture from Atlanta, but there is video.]
I gave a short booth presentation on Best Practices for Sigma-metrics at the Abbott Diagnostics booth during the AACC/ASCLS convention. This is now available online for those interested.
The link, after the jump.
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Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
It's that time of year again, where the usual and not-so-usual suspects of the laboratory world gather and discuss science - mixed in with a healthy dose of commerce. We have just returned (and are still recovering from) the annual AACC/ASCLS meeting in Atlanta, Georgia.
James O. Westgard at the Westgard QC booth for the 2011 AACC/ASCLS exhibition
More pictures and details of the convention after the jump...
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A guest post by Nils Person, PhD, FACB
I recently read the essay "The QC We Really Do" with great interest and found the information very useful. However, there was one topic that I was concerned about. It had to do with re-calibration in response to QC rule failure. The essay indicated that re-calibration is a common response to QC rule failure.... and I am not sure that is a good strategy. .
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