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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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
In the December 2011 issue of Point of Care journal, an interesting study was published:
Preanalytical Errors in Point-of-Care Testing: Auditing Error of Patient Identification in the Use of Blood Gas Analyzers, Natalie A Smith, David G Housley, Danielle B. Freedman, Point of Care, Volume 10: Number 4, December 2011.
The study looked at patient identification errors on a blood gas analyzer in various departments in a hospital. Bearing in mind that this is just one type of pre-analytical error, what do you think the rate was? Given around 100,000 tests, what would you guess as the number of defects?
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Posted by Sten Westgard, MS
The news hasn't been getting any better over at Theranos. Since the Wall Street Journal pierced the facade on Theranos' promise of revolutionizing the lab test industry, there have been additional stories that Walgreens is seeking an exit from their partnership, that some of their premier clinical partners, Intermountain Healthcare and Cleveland Clinic, have not even started work on any validation studies with Theranos technologies, and that Capital BlueCross has put a stop to Theranos blood-drawing at the insurer's retail store in Pennsylvania.
But that's nothing compared the release of the full, but redacted, CMS inspection report of Theranos' Newark, California laboratory.
Earlier, we had seen the top sheet of the report, noting five major violations that meant Theranos was putting its patients in "immediate jeopardy."
The full report, more than 121 pages long, is as bad an inspection report as I have ever seen. More explanation of this, after the jump...
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Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
According to a recent CAP Q-Probe, approximately how many glucose tests are being bracketed by QC events?
Is it
- 5,000 tests between QC runs
- 500 tests between QC runs
- 50 tests between QC runs
- 5 tests between QC runs
The answer, after the jump
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Posted by Sten Westgard, MS
Earlier this month (July) I came across a series of revealing posts on a listserv about the quality of glucose meters. For me, it raised the question, just what defect rate is acceptable at the point of care?
- 0.00034%
- 1%
- 5%
- 10%
- 40%
- 75%
- 100%
What level of defect rate do you believe is being seen at the point of care? the answer (after the jump) might astonish you...
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Posted by Sten Westgard, MS
As many of you know, the FDA has issued new draft guidelines about Blood Glucose Monitoring Test Systems for Industry and Manufacturers.
Recently, the AACC held an excellent webinar where an Dr. Courtney Lias, PhD from the FDA discussed the intentions of the new guidances and then fielded a LOT of questions. I don't want to step on what Dr. Lias and the AACC accomplished during their webinar. There was useful information in that presentation and I encourage others to consider getting those materials once they become available on the AACC website.
However, while reading through the guidances and talking to laboratories these past few months, I thought I might share a few observations...
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Posted by Sten Westgard, MS
Last month I was fortunate enough to attend the INTERCAL meeting in Lima, Peru, hosted by SIMED.