Posted by Sten Westgard, MS
In June of this year, Zoe Brooks presented an AACC-sponsored webinar with the title, Laboratory QC: Bridging the Gap Between Theory and Practice. During this webinar, Zoe presented a poll and more than 100 participants responded. The results are very interesting...
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Posted by Sten Westgard, MS and James O. Westgard, PhD
As reported elsewhere on the website, several of the symposiums this year were on standardization and harmonization for various analytes. This year, however, there was an added note of urgency. For many laboratorians, standardization seems like a somewhat esoteric subject, important but not necessarily pressing. But with the expectation of widespread implementation of electronic medical records, the problems with “comparability” of test results (and analytical methods) are about to become stark.
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Posted by Sten Westgard, MS
A recent abstract from the 2009 IFCC/EFCC (Euromedlab) caught my eye:
Quality Indicators for Laboratory Process; assessment in the Trento Department of Laboratory Medicine.
I Caola, C Pellegrini, N Bergamo, E Saurini, P Caciagli.
CCLM 2009
Examining the quality records of five laboratories, they applied a set of Quality Indicators from the IFCC. Errors were tracked and tabulated. The results are quite interesting.
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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
With sincere thanks to Carolyn Maurer, the Director of the CAP 15189 program.
As the new IQCP regulations kick in, it's been interesting to see the international reaction to them.
I admit that I thought the IQCP impact would be contained within the US, that contagion would not spread to the international community. After all, IQCP is only a required option for labs within the US, and then only required for labs that seek to find a replacement to their now-outdated EQC policies. For labs that don't want to reduce their QC frequency below once a day, there's no need to create an IQCP at all.
But the situation appears to be more complicated. CAP, which has a significant international presence, is rolling out IQCP to all of its members, not just its US customers.
In light of that, I asked CAP how it balances the IQCP reduced QC frequency with the ISO 15189 standards. Their answers, after the jump...
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Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
A recent op-ed in the New York Times by Dr. Robert Wachter as well as an interview with Don Berwick in HealthLeaders Media broached a taboo topic: is healthcare measuring too much?
'[T]he measurement fad has spun out of control. There are so many different hospital ratings that more than 1,600 medical centers can now lay claim to being included on a “top 100,” “honor roll,” grade “A” or “best” hospitals list. Burnout rates for doctors top 50 percent, far higher than other professions. A 2013 study found that the electronic health record was a dominant culprit. Another 2013 study found that emergency room doctors clicked a mouse 4,000 times during a 10-hour shift. The computer systems have become the dark force behind quality measures.'
How Measurement Fails Doctors and Teachers, New York Times, January 16, 2016
As the global debate over establishing the best error models and performance specifications rages, laboratories are probably asking themselves the same questions that the doctors are asking: how many metrics are too much?
A possible answer, or at least some more questions, after the jump...
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Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
An interesting abstract was published at the Paris IFCC meeting. It detailed the EQA performance of a set of 12 public laboratories in Catalonia. Can you guess what the failure rate for these labs for biochemistry EQA?
- 14.5%
- 14%
- 3%
- none of the above
The answer, after the jump...
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Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
We knew that the accreditation agencies needed to develop their own policies to handle the new CMS IQCP regulations. CAP gets the prize for being first out of the gate with some practical steps, as well retaining some safeguards for quality.
IQCP, if it's not already burned into your head, stands for Individualized Quality Control Plan, and this is supposed to be the replacement for the EQC policies which have been in place for several years. The EQC policies are being replaced, you may recall, because they are scientifically untenable. It was hoped that IQCP was going to be more scientifically robust. That remains to be seen. CAP is attempting to assure that it will implement the CMS IQCP regulations but also provide a higher level of quality assurance than that low bar.
More after the jump.
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