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  1. An Article entitled Six Sigma can be dangerous to your health will appear in Accreditation and Quality Assurance. After one year, I can post this article on this web site.

  2. As of 1/1/2008, all IFTF sales will be donated to charity.

  3. Recently, approval was granted for a waiver assay for a client, submitted using the FDA draft guidance for waiver applications.

  4. IFTF FMEA software goes international.  IFTF is available in any foreign language at no additional charge. See this link for details.

  5. Articles recently published.

    1. Letter: A recommended improvement for specifying and estimating serum creatinine performance. Clin Chem 2007;53:1715-1716.

    2. Comments on the editorial "On quality of a measurement result" Accred Qual Assur, 2007;12:263-264.

    3. FDA’s new proposed waiver application guideline – how it differs from previous performance evaluations. IVD Technology 2006; 12;24-31.

    4. Uncertainty Intervals Based on Deleting Data Are Not Useful Clin. Chem., 2006;52:1204-1205.

    5. Recommendation to treat continuous variable errors like attribute errors. Clin Chem Lab Med 2006;44(7):797–798.

    6. Dynamic rather than static performance measures are needed to improve patient safety. Accred Qual Assur 2006;11:644-646.  

    7. More on reporting medical errors. Letter in Clin. Chem. 2006;52:2120.

  6. Krouwer Consulting has developed an Excel add-in (ACT=Assay Comparison Tool) to compare quality among different assays (e.g., chloride, cholesterol), by calculating process capability metrics from quality control data. It is described here.

  7. Krouwer Consulting has developed risk management software (IFTF), which performs integrated Fault Tree / FMECA analysis. It is described here. The software is accompanied by an 85 page guide to FMEAs, published by AACC Press.

  8. Krouwer Consulting presented a workshop on how to reduce lab errors by using FMEAs at the AACC meeting in Orlando in July 2005. This session is also available on request.

  9. Training topics and the schedule of seminars may be viewed here.

  10. A review on FMEAs has been published in the June 2004 issue of Archives of Pathology and Laboratory Medicine.

  11. A Letter to the Editor about Root Cause Analysis (RCA) is in the June issue of the International Journal for Quality in Health Care (Int J Qual Health Care 2004 16: 263) as a response to Don Berwick's editorial in The Washington Post .

  12. A Letter to the Editor appeared in the July 2003 issue of Accreditation and Quality Assurance about 1) the problems for labs to construct uncertainty intervals for diagnostic assays as specified by GUM (Guide for the expression of uncertainty in measurement) and 2) the failure of ISO 9001 to affect quality in the in-vitro medical diagnostics industry. Each of these topics was followed up with a full paper. Read the Letter - the original publication is available at LINK at http://link.springer.de.

The full paper about GUM: "A Critique of the GUM Method of Estimating and Reporting Uncertainty in Diagnostic Assays" has been published in Clinical Chemistry (49:1218-1221 (2003). This was a "point" "counterpoint". Read Jan's response to the counterpoint (also published as an eLetter to Clinical Chemistry).

The full paper about ISO: "ISO 9001 has had no effect on quality in the in-vitro medical diagnostics industry" has been published:  Accred. Qual. Assur., 9: 39-43 (2004).