Posted by Sten Westgard, MS
A lot of interesting studies coming out this month, unfortunately none of them with encouraging news about the US healthcare system.
The latest, from Sunil Eappen, MD, Atul Gawande, MD et al, Relationship Between Occurence of Surgical Complications and Hospital Finances, JAMA, April 17, 2013, Vol. 309, No. 15 1599-1606
Take a guess: do US hospitals make more money when things go wrong, or less?
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Posted by Sten Westgard, MS
There was some very interesting testimony given in front of the US Congress this week. Boeing and other FAA officials discussed their failure to adequately test the lithium-ion batteries found in the 787 Dreamliner. As you probably already know, on two of the Dreamliners, those batteries malfunctioned and caused fires, which then caused the entire fleet to be grounded.
In the New York Times, it was reported "Boeing’s chief engineer on the 787, Mike Sinnett, said the calculation that a battery would fail only once every 10 million flight hours applied to the design of the battery and did not include possible manufacturing flaws."
In fact, two battery failures and serious fires occurred after less than 52,000 flight hours. The risk was actually over 350 times higher than their estimate!
How could they be so wrong? More after the jump...
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Posted by Sten Westgard, MS
Can you guess which of these categories is the leading source of successful malpractice claims?
- Surgical mishaps
- Obstetrical problems
- Medication errors
- Anesthesia disasters
- Diagnostic errors
- Treatment errors
- Something else entirely?
The answer, after the jump...
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Posted by Sten Westgard, MS
Dr. Westgard had the pleasure of taking part in the Bio-Rad industry workshop on July 17th, which was focused on Quality Control for the Future - Risk Management EP23 for Laboratories.
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Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
As we wait for more details about EP23 and how CMS and CLIA will actually enforce the implementation of Risk QC, the latest morsels to emerge are quite tantalizing.
On the CLSI website, a Q&A has been posted. Here is one interesting bit:
"3. Is there a planned format for documenting the EP23 QCP to present to surveyors?
There is no specific format that is required for the presentation of a QCP. The example in EP23 and those currently being drafted for future education will present some options, but laboratory directors have flexibility in the formatting of their QCPs. There may be some elements, components, or data that the Centers for Medicare & Medicaid Services (CMS) will look for when assessing compliance, but nothing standard."
This is an interesting question and an even more intriguing answer. The new standard will have "nothing standard" about its implementation. Presumably labs that use the workbooks sold by CLSI will be able to fulfill any requirements for proper design of Individual QC Plans.
So why won't there be a standard QC Plan format?
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Posted by Sten Westgard, MS
In the recent issue of Clinical Chemistry, an editorial reviews the current state of Vitamin D testing: "There is common agreement that 25-OHD is a 'difficult' analyte."
25-Hydroxyvitamin D: A Difficult Analyte, Graham D. Carter, Clin Chem 58:3; 486-488 (2012).
At the same time, the editorial notes that marked process is being made:
"Nevertheless, results submitted to the international Vitamin D External Quality Assessment (DEQAS) have shown a gradual reduction in interlaboratory imprecision (CV) in recent years - from >30% in 1995 to 15% in 2011."
The question is, is that reduction in imprecision good enough? Or is the quality required by Vitamin D still too "difficult"?
More after the jump...
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Posted by Sten Westgard, MS
Heads up. There's a new abbreviation in town: IQCP
Can you guess what IQCP means?
- Information Quality Certified Professional
- Individualized Quality Control Plan
- Intelligent Quality Control Plan
- Incoherent Quality Control Plan
- Ill-conceived Quality Control Plan
The answer, after the jump...
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Posted by Sten Westgard, MS
So we all know that Risk Analysis is coming to laboratories in the US. (click here if this is news to you). But Risk Analysis, particularly the FMEA technique (Failure Mode and Effects Analysis), is not new to healthcare. Outside the laboratory, plenty of healthcare practitioners have been performing FMEA.
So what do they think about this technique? Try and guess which one of these responses is from a someone in healthcare:
- "The jury's still out on the FMEA process because... has anybody evaluated FMEA as a tool for analysing risk? And it turns out there isn't... well why are we doing this process?... When all it is doing is bringing a few things to the surface, which is no bad thing, but it's not a validated process."
- "...Forget FMEA. It doesn't really work effectively, I don't think, and the scores are a hindrance rather than anything else, year... We wasted a lot of time on FMEA before we realized, this isn't actually working. Yeah, because I think you can get caught up on just the score, that's the thing."
- "The scoring in the FMEA teams need to be the same people, if you change half way through because of the highly subjective interpretation things change dramatically."
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
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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Laboratory Quality Control Based on Risk Management
Posted by James O. Westgard, Sten A. Westgard
Posted by Sten Westgard, MS