Tools, Technologies and Training for Healthcare Laboratories

Method Validation Matters: Just Ask Theranos

Posted by Sten Westgard, MS

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Question for You: Do You MU?

Posted by Sten Westgard, MS

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New Publication: Useful measures and models for quality

Posted by Sten Westgard, MS

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New publication: PT/EQA on Sigma Scale

Posted by Sten Westgard, MS

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Basic QC in Chinese!

Posted by Sten Westgard, MS

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Cleveland Clinic ... Cheating Catastrophe?

Posted by Sten Westgard, MS

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Pop Quiz: what's the EQA failure rate of laboratories?

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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Sigma-metrics in Molecular Diagnostics

Posted by Sten Westgard, MS

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Webinar Alert: Simplify your ISO 15189

Posted by Sten Westgard, MS

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CAP rolls out the first practical IQCP guidelines

Posted by Sten Westgard, MSCAP-elligibility-IQCP

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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Pop Quiz: What's the biggest source of errors in a Nigerian QMS?

Posted by Sten Westgard, MS

A recent article about the experience of QMS tracking in a clinical laboratory in Nigeria raised some interesting questions about sources of errors in "developing world" laboratories.

Where would you expect a Nigerian Human Virology laboratory (HVL) to experience the most problems?

  • pre-analytical processes
  • analytical processes
  • post-analytical processes

The answer, after the jump...

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When did the US become irrelevant to Quality Goal Setting?

Posted by Sten Westgard, MS

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Pop Quiz: What's an acceptable POC defect rate?

Posted by Sten Westgard, MS

MissedTarget

Earlier this month (July) I came across a series of revealing posts on a listserv about the quality of  glucose meters. For me, it raised the question, just what defect rate is acceptable at the point of care?

  • 0.00034%
  • 1%
  • 5%
  • 10%
  • 40%
  • 75%
  • 100%

What level of defect rate do you believe is being seen at the point of care? the answer (after the jump) might astonish you...

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New Book: Basic Quality Management Systems

Posted by Sten Westgard, MS

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Upcoming Workshop: Time to Change Your QC?

Posted by Sten Westgard, MS

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HbA1c: Bias is a big deal, and CV is critical

Posted by Sten Westgard, MS

Two interesting abstracts and papers concerning HbA1c came out recently. As laboratories switch from fasting blood glucose to HbA1c to diagnosis diabetes, the importance of the method performance of HbA1c methods is becoming critical.

But what's more important? Bias or CV?

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Upcoming Workshop: Got Sigma?

Posted by Sten Westgard, MS

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Upcoming Workshop: Right QC, Right Method, Right Controls?

Posted by Sten Westgard, MS

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Journal alert: Sigma-metrics in CCLM

Posted by Sten Westgard, MS

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Q&A: How to Plan for IQCP?

PosteQuestionPathsAheadd by Sten Westgard, MS

As many of you know, EQC is out and IQCP is in. As the expiration date for EQC approaches in 2016, labs need to learn more ab
out Risk QC and IQCPs. CMS has an email address where you can send questions.

We tried out the question and answer line with CMS, see the results after the jump...

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