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 [first posted on LinkedIn]
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
The third year of Medicare penalties has been meted out. This year hospitals were penalized for avoidable complications such as various types of infections, blood clots, bed sores, falls, and new to the list this year, the prevalence of two types of bacteria resistant to drugs.
Do you want to guess the percentage of injuries that impacted patients in US healthcare?
- 15%
- 11.5%
- 1.15%
- 0.115%
The answer, after the jump...
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Posted by Sten Westgard, MS
Antwerp participants vote on meeting conculsions
As some of you know, the Quality in the Spotlight conference has one dinner that is infamous for its limerick contest. Finlay MacKenzie of the UK presides as the Master of Ceremonies, and all diners are invited to participate in constructing a limerick based on the events of the first day of the conference. Yes, that's right - try to turn statistics into lyrical poetry. A very difficult feat indeed.
And who was 2016's winner, you may ask?
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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