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

In a recent issue of CCLM, an interesting opinion paper reported on a pilot study of the quality of UK laboratories.

Given 5,812 QC data points on 5 different platforms in 9 different laboratories measured over 6 months, and a quality goal of 7.0%  how many of those laboratories do you think achieved 5-Sigma quality?

• 100%
• 75%
• 50%
• 25%
• less than 25%

The answer, after the jump...

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

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?

Posted by Sten Westgard, MS

Posted by Sten Westgard, MLO

In the November 2012 MLO magazine there is an intriguing article by Roy Midyett, a hematology supervisor, titled "Empty QC"

Here's how Mr. Midyett defines "Empty QC":

"Empty QC is any nominal QC that does not give techs performing the test any more confidence than they would have without the QC, and has by logic or experience, no influence on the reporting of the test."

Is Mr. Midyett correct? Have our QC procedures become meaningless gestures? More after the jump.

Posted by Sten Westgard, MS

So here's a Normalized Method Decision chart for a cholesterol method.

Which method would you choose?

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

I just wanted to share some pictures of a trip taken back in late April.

The Asian Society of Continuing Medical Education was kind enough to invite me to present in a workshop titled "Assuring Quality, Standardization, and Efficiency in the Laboratory 2012"  In Delhi and Mumbai.

Group picture, Mumbai

More pictures, after the jump.

Posted by Sten Westgard, MS

Here's a range of statistics describing the performance of a glucose method. Try to pick: Which one has acceptable performance?

1. method with combined uncertainty 3.69%
2. method with combined uncertainty 6.79%
3. method with expanded uncertainty 7.38%
4. method with expanded uncertainty 13.58%
5. method with 3.78 Sigma

Which method would you pick?

Posted by Sten Westgard, MS

Recently, the journal In Vitro Diagnostics Global News a publication of CGI KK and in association with CAP Today, has begun publishing a series of translations of Westgard articles into Japanese:

The title of the series is Think QC Again, an important message regardless of language or country.

Posted by Sten Westgard, MS

Heads up. There's a new abbreviation in town: IQCP

Can you guess what IQCP means?

1. Information Quality Certified Professional
2. Individualized Quality Control Plan
3. Intelligent Quality Control Plan
4. Incoherent Quality Control Plan
5. Ill-conceived Quality Control Plan

The answer, after the jump...

Posted by Sten Westgard, MS

Recently, a user submitted a question about the mandatory use of the 10_x rule on chemistry analytes as mandated by ISO 15189 through NABL:

"Specific criteria of accreditation of NABL India (for ISO 15189) say that 10x should be considered as a violation for clinical chemistry  and Immunoassay parameters. However we understand that Westgard rules consider it as a warning only. Please advise."

So, the central question is, does ISO 15189 mandate the use of the 10_x control rule?

Posted by Sten Westgard, MS  [first posted on LinkedIn]

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

Thanks to our hosts, our partnets, and our participants in Medellin, Colombia!

(more, after the jump)

Posted by Sten Westgard, MS