Krouwer Consulting
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Krouwer Consulting
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Welcome to Krouwer Consulting Dr. Jan Krouwer has over 20 years of experience in the medical diagnostics industry and is now an independent consultant. His focus is:
Solutions to quality problems through statistics FMEA risk management for hospitals Training
in the above areas
~~~~~~~~~~ Recent Essays ~~~~~~~~~~ NOTE: Recent entries are now in blog format, here or at Wordpress. New Essay 6/12/07 - A Pedigree of error reduction approaches - This essay discusses the influence of cognitive psychologists on error reduction methods and how these concepts can be used with reliability tools that came from the defense industry. New Essay 5/17/07 - What it takes to get your idea accepted - This essay chronicles 15 years of trying to get the right model accepted for total analytical error for diagnostic assays. New Essay 4/24/07 - Risk management III - How the CLSI document EP18 (under revision) stacks up against ISO standards for the clinical laboratory FMEA FRACAS Fault Trees and Pareto - 1/19/07 - By using an illustration and a short discussion, the relationship among these terms is shown. When to Conduct a FMEA - 1/15/07 - FMEAs are often conducted late in the product development cycle. This essay suggests that FMEAs should be conducted much earlier. This essay also suggests a new feature should be present in FMEAs. The Reverse Pareto - not a good idea - 1/05/07 - Reducing the Risk Priority Number (RPN) after instituting control measures is recommended as a measure to evaluate the quality of a FMEA. This essay suggests why this is not a good idea. Error Reporting Systems - 11/16/2006 - A recent study discusses efforts to reduce specimen identification errors in the clinical laboratory. This paper is well worth reading and is discussed in the context of error reporting systems. Unit use devices, POC, and Quality Control - 11/9/06 - There has been much talk about the uniqueness of unit use devices and difficulty with external QC. This essay shows that unit use devices are not all that different and suggests some alternatives besides external quality control. Risk Management II - 8/22/06 - Beware of the statement - "that problem can be handled by risk management." This essay explains why. Customer Misuse - 7/31/06 - What does customer misuse mean and more importantly how can it be prevented to reduce medical errors. Bland Altman Plots - 7/05/06 - This essay explains why one should plot Y-X vs. X, not (Y+X)/2 when X is a reference method. This is contrary to the advice given by Bland Altman. A simulation program is included. Fault Isolation - 6/19/06 - This essay explains what fault isolation is and why it is important. This is discussed for detection recovery systems for quality control and the CMS proposal to reduce the frequency of quality control. Pay for Performance II - 6/04/06 - Besides the errors that might occur for approving a treatment, one must consider the consequences of denying approval, and how to improve approved treatments. More on GUM - 5/26/06 - The effort to implement GUM for commercial diagnostic assays continues. This essay summarizes my concerns and also contains an eLetter to Clinical Chemistry Frequency of Preventable Medical Errors II - Where's the data - 5/14/06 - Error rates are hard to come by. This essay discusses a rate for wrong site surgery and the Universal Protocol, which is a means to prevent wrong site surgery. Proficiency testing and six sigma - 4/11/06 - A recent paper discusses the analytical quality of laboratory testing based on proficiency testing and using six sigma . This essay describes some problems with the use of proficiency testing in general and this use of six sigma. Solutions are recommended. Uniformity of Claims - 3/30/06 - There was a CLSI document about this but the project was canceled in part because of a new ISO standard. This essay describes what happened and why the ISO standard does not replace the (canceled) CLSI standard. FMEA Validation - 2/21/06 - It's easy to assume that detection and recovery steps always work. This essay considers what happens when this assumption isn't true and what to do about it. Outliers in QC and Proficiency Testing - 2/08/06 - A recent recommendation to analyze QC data among assays, recommends deleting statistical outliers. This essay suggests why this is not a good idea. Discrepant analysis in everyday situations - 2/01/06 - Discrepant analysis involves repeating the analysis of selected samples. This essay explores how this practice affects QC and patient samples. The quality of quality initiatives - 1/04/06 - Some examples illustrate problems with a quality initiative and some suggestions to avoid these problems. Beware the technical administrator - 12/14/05 - At some point, the boss won't have the required technical knowledge to judge the merit of technical proposals. This essay deals with this issue. It's Up To the Lab Director - 11/28/05 - This phrase appears often, especially in standards with respect to assay performance goals. This essay discusses what this phrase usually means and what should happen. Publishing in peer reviewed journals or on the web. - 11/16/05 - Issues are discussed on the merits of each publication type. Risk Management. - 11/15/05 - Everyone's talking about risk management. In practice it can range from almost no activity to an extensive program. Fault tree example as an aid to help complete a FMEA. - 10/18/05 - This example also illustrates fault tree quantification. Comments on the FDA Guidance for Waiver Applications - 9/29/05 - This guidance is a radical departure from previous guidance on evaluating assays and represents a vast improvement. FMEA vs. lab performance goals - there's a big difference - 9/19/05 - Laboratorians are familiar with lab performance goals for precision and bias. They may be surprised by goals for the discrete types of errors such as a patient sample mix-up. Pay for performance - the missing measure - 6/19/05 - Pay for performance has been advocated as a means to improve quality. The number of measures suggested is huge, but as this essay discusses, one measure is missing. FMEA vs. FRACAS vs. RCA - 6/16/05 - What are the differences among these reliability techniques and when should each be used. Equivalent QC II - 6/12/05 - One often hears the quality phrase "Do it right the first time." In a recent article, prevention was favored over detection. This essay shows that both prevention and detection have roles for diagnostic assays. ISO Terminology - globally harmonized or gobbledygook - 6/9/05 - Does the ISO terminology help or hinder with comprehension of statistical and quality concepts? Issues with standards groups - 5/13/05 - This essay addresses conflicting interests in groups such as CLSI (formerly NCCLS) that prepare standards used to evaluate assay quality. Preventable medical errors: Preventability and regulation - 4/16/05 - This essay addresses the meaning of preventability, how it is measured as well as the effect of regulations on reducing the risk of preventable medical error. Should labs run more QC? - 3/31/05 - The essay addresses Westgard's assertion that until methods are improved, labs should run more QC in order to meet quality requirements. Latent Errors 3/12/05 - This essay explains why the term "latent errors" is misleading and recommends an alternative. Equivalent QC 2/26/05 - This essay explores some myths with internal monitoring systems as well as other issues. Go to the AACC expert online access presentation How to write a report that will be read 2/24/05 - This essay explains why there should be a recommendations and conclusions section for all reports based on data. Recovery in FMEA 2/17/05 - Little has been written about 'recovery' as a means to prevent medical errors. This essay explains why recovery is important. Detection in FMEA 2/15/05 - Likelihood of detection is often recommended for inclusion in a Pareto ranking. This essay suggests why that is not a good idea. Near Miss 2/12/05 - The anatomy of a medical error is described through an event -> detection -> recovery sequence. This model allows for the description of sentinel events, near misses, chance and planned detection, and unsafe situations. |
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Hardware
reliability using fault trees, FMECAs,
