Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Laboratories in the US probably already know this: their healthcare institutions are getting hit with fines from CMS due to excessive 30-day readmission rates for three conditions:
- (AMI) Acute myocardial infarction
- (HF) Heart Failure
- Pneumonia patients
CMS is imposing increasing fines for hospitals that have excessive readmissions. Guess how many hospitals have been fined - and how much money they've had to pay back...
-----
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
On August 16th of this year, CMS issued a new memo about IQCPs. If you recall, IQCP stands for Individualized Quality Control Plan, and it's part of the new Risk QC being proposed by CMS as a replacement for EQC. The CLSI guideline EP23, which came out about two years ago, laid out the broad outlines of this new policy, but we have been waiting for the government regulations to spell out the specifics of implementation and interpretation.
Posted by Sten Westgard, MS
The biggest news coming out of the AACC/ASCLS conference in Houston was made by Judy Yost of CMS.
So the new future is IQCP. Remember what that stands for?
- It's Quickly Coming to Pass
- I've Quit Caring about Performance
- It's Quackery, Chaos, and Pablum
- I'm Quietly Compromising my Processes
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...
-----
Posted by Sten Westgard, MS
Remember in 2017 when there were predictions that Theranos wouldn't last out the year?
It appears reports of Theranos' death were greatly exaggerated... or maybe not
-----
Posted by Sten Westgard, MS
In Biochemia Medica, a recent article detailed the Minimum requirements for the estimation of measurement uncertainty:Recommendations of the joint Working group for uncertainty of measurement of the CSMBLM and CCMB.
Can you guess how many?
-----
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
After premiering this event at ADLM, we are opening it up to everyone through zoom. Please join us September 25th, at 11 am central standard time. At last, a frank look at why we need to do less QC, and how we can make those reductions safely. If you enjoy being out of control every day, if you get a thrill every time you have to repeat a con...
The fallout of the IDVR continues. An interesting quote from a recent paper: "Although the EC aimed at bringing safe and effective medical tests to the EU-market, ~9,000 tests out of ~40,000 tests got lost in transition." Nearly a quarter of tests suddenly became unacceptable? That places IVDR at just above 2.2 Sigma. The proposed soluti...
A recent question came to me via social media: "Hello Sir, Good morning, How are you? I wanted to know is still 10x rule is coumpulsary?[stet.] Even [when] we are using lab mean and lab SD. Please share the details.Thanks and Regards, [anonymous]"10:x is not compulsory by any regulation that I am aware of. Many regulations require you to...