Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
A recent New York Times Sunday editorial focused on the deplorable state of medical device regulation. We simply can no longer trust FDA clearances, particularly 510ks:
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
At the AACC/ASCLS conference in San Diego, many of the Sigma VP laboratories contributed to a poster on evaluating the applicability of various analytical performance specifications for AST:
Multisite study of AST analytical performance reveals disparities in global performance specifications
The full poster can be downloaded from our westgard.com download section here. (free membership required)
But what was most rewarding was meeting with many of the co-authors who came to the meeting.
Ms Ginny Foo, Mr. Rajkumar Rengaraju, Co-authors from Innovative Diagnostics, Singapore
more pictures 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
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
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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