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Books

  1. Assay Development and Evaluation: A Manufacturer’s Perspective. Jan S. Krouwer, AACC Press, Washington DC, 2002.
  2. Managing risk in hospitals using integrated Fault Trees / FMECAs. Jan S. Krouwer, AACC Press, Washington DC, 2004.

Thesis

Jan S. Krouwer: Approaches To the Synthesis of Benzene Bisepoxides, Ph.D. Thesis, M.I.T., Cambridge, MA, 1973.

Peer Reviewed Articles

  1. Jan S. Krouwer and Bernard M. Babior: The Mechanism of Action of Ethanolamine Ammonia-Lyase. Reaction of a Postulated Organocorrin Intermediate with Enzyme, J. Biol. Chem., 252, 5004-5009 (1977).
  2. Jan S. Krouwer, Richard M. Schultz, and Bernard M. Babior: Aminoacetaldehyde, a Substrate Analog for Ethanolamine Ammonia-Lyase, a B12-dependent Enzyme, J. Biol. Chem., 253, 1041-1047 (1978).
  3. Jan S. Krouwer and Joe P. Richmond: The Synthesis and Reactions of Enamine N-oxides, J. Org. Chem., 43, 2464-2466 (1978).
  4. Jan S. Krouwer, Barton Holmquist, Ruby S. Kipnes, and Bernard M. Babior: The Mechanism of Action of Ethanolamine Ammonia-Lyase, an Adenosylcobalamin-dependent Enzyme. Evidence that Carbon-Cobalt Bond Cleavage is Driven in Part by Conformational Alternations of the Corrin Ring, Biochim. Biophys Acta, 612, 153-159 (1980).
  5. Steven W. Graves, Jan S. Krouwer, and Bernard M. Babior: The Mechanism of Ethanolamine Ammonia-Lyase, an AdoCbl-dependent Enzyme. Studies with Isopropanolamine, A Substrate for the Enzyme. J. Biol. Chem., 255, 7444-7448 (1980).
  6. Jan S. Krouwer and Robin Rabinowitz: How to Improve Estimates of Imprecision, Clin. Chem., 30, 290-292 (1984).
  7. Patricia E. Garrett and Jan S. Krouwer: Method Evaluation II: Precision and Sensitivity Considerations: J. of Clinical Immunoassay, 8, 165-168 (1985).
  8. Jan S. Krouwer: Improving the Reporting of Immunoassay Specificity, Clin. Chem., 32, 1980 (1986).
  9. Jan S. Krouwer: Cumulative Distribution Analysis Graphs - An Alternative to ROC Curves, Clin. Chem., 33, 2305-6 (1987).
  10. Jan S. Krouwer, William N. Stewart, and Brian Schlain: A Multi-factor Design for the Evaluation of Random Access Analyzers, Clin. Chem., 34, 1894-6 (1988).
  11. Brian Schlain and Jan S. Krouwer: Multi-factor Designs II. A Design for Identifying Instruments with Sample-to-sample Carryover and Drift. Clin. Chem., 35, 2118-2120 (1989)
  12. Jan S. Krouwer: Multi-Factor Designs IV. How Multi-factor Designs Improve the Estimate of Total Error by Accounting for Protocol Specific Bias. Clin. Chem., 37, 26-29 (1991).
  13. Jan S. Krouwer: Estimating Total Analytical Error and Its Sources: Techniques to Improve Method Evaluation. Arch Pathol Lab Med., 116, 726-731 (1992).
  14. Jan S. Krouwer and Brian Schlain: A Method to Quantify Deviations From Nonlinearity. Clin. Chem., 39, 1689-93, (1993).
  15. Jan S. Krouwer and Katherine L Monti: A Simple Graphical Method to Evaluate Laboratory Assays, Eur. J. Clin. Chem. and Clin. Biochem., 33, 525-527 (1995).
  16. Jan S. Krouwer: Beware the Percent Completion Metric. Research Technology Management, 41, 13-15, (1998).
  17. Jan S. Krouwer: Evaluation of Assay Systems. Clin. Chem. News, 27, 10-14 March 2001
  18. Jan S. Krouwer: Setting Performance Goals and Evaluating Total Analytical Error for Diagnostic Assays. Clin. Chem., 48: 919-927 (2002).
  19. Jan S. Krouwer: Using a Learning Curve Approach to Reduce Laboratory Error, Accred. Qual. Assur., 7: 461-467 (2002).
  20. Jan S. Krouwer: A Critique of the GUM Method of Estimating and Reporting Uncertainty in Diagnostic Assays Clin. Chem., 49:1818 -1821 (2003).
  21. Jan S. Krouwer: ISO 9001 has had no effect on quality in the in-vitro medical diagnostics industry. Accred. Qual. Assur. 2004;9:39-43.
  22. Jan S. Krouwer: An improved FMEA (Failure Mode Effects Analysis) for Hospitals. Arch Pathol Lab Med 2004;128:663-667.
  23. Jan S. Krouwer: Recommendation to treat continuous variable errors like attribute errors. Clin Chem Lab Med 2006;44(7):797–798.
  24. Jan S. Krouwer: FDA's proposed  CLIA waiver application guideline. IVD Technology 2006; 12;24-31.
  25. Jan S. Krouwer: Dynamic rather than static performance measures are needed to improve patient safety. Accred Qual Assur 2006;11:644-646.
  26. Jan S. Krouwer: How clinical laboratories can evaluate false positives and false negatives. Point of Care: The Journal of Near-Patient Testing & Technology, 2008;7:16-18.
  27. Jan S. Krouwer: Ten tips to improve risk assessment IVD Technology 2008; 14;16-23.
  28. Jan S. Krouwer: Six Sigma can be dangerous to your health. Accred Qual Assur 2008; in press.

Reviews

  1. Jan S. Krouwer and Bernard M. Babior: The Mechanism of Cobalamin-Dependent Rearrangements, Molecular and Cellular Biochemistry, 15, 89-108 (1977).
  2. Bernard M. Babior and Jan S. Krouwer: The Mechanism of Action of B12-dependent Enzymes, Critical Reviews in Biochemistry, 6, 35-102 (1979).
  3. Jan S. Krouwer: Use of analytical goals by health care manufacturers, in Frontiers in Laboratory Practice Research. in Proceeding of 1995 Institute on Critical Issues in Health Laboratory Practice: Frontiers in Laboratory Practice Research US Dept. of Health and Human Services 1996.

Abstracts

  1. Jan S. Krouwer and Bernard M. Babior: The Mechanism of Action of Ethanolamine Ammonia-Lyase. Studies with Formylmethylcobalamin, Fed. Proc., 35, 1541 (1976), (Abstract).
  2. Jan S. Krouwer and Luis P. Leon: Routine Assay for Serum Thyroxine Using the Technicon SMAC Biochemical Analyzer, Clin. Chem., 26, 1067 (1980), (Abstract).
  3. Jan S. Krouwer and Brian Schlain: A Statistical Method for Estimation of a Random Interference Component in Method Comparison Studies, Clin. Chem., 27, 1061 (1981), (Abstract).
  4. Douglas K. Chu, Jan S. Krouwer, Mary Ellen McDermott, Neil M. Wolfman, and Shyun L. Yun: An Investigation of the Stability of the IFCC AST and ALT Reagents, Clin. Chem., 28, 1599 (1982), (Abstract).
  5. Chien-Kuo Yeh, Jan S. Krouwer, and Roger Bauer: An Improved Uric Acid Method for Technicon SMAC System, Clin. Chem., 29 1285 (1983), (Abstract).
  6. Jan. S. Krouwer, Patricia E. Garrett, and Sanford R. Kurtz: A Method to Optimize Calibration Frequency, Clin. Chem., 31, 1017 (1985) (Abstract).
  7. Jan. S. Krouwer: Errors in Calculating Minimum Detectable Dose, Clin. Chem., 32, 1187 (1986) (Abstract).
  8. Jan S. Krouwer: A Strategy For Dealing With Values Close to The Medical Decision Point (Abstract) Clin. Chem., 33, 910 (1987).
  9. Jan S. Krouwer: A Multi-factor Design for the Evaluation of Random Access Analyzers, (Abstract) Clin. Chem., 34, 1192-3 (1988).
  10. Jan S. Krouwer and Jean O'Malley: Evaluation Of an Ionized Calcium/pH Analyzer, (Abstract) Clin. Chem., 34, 1234 (1988).
  11. Lisa E. Crosby and Jan S. Krouwer: Diagnostic Efficacy of Magic Lite PTH, (Abstract) Clin. Chem., 35, 1187-88 (1989).
  12. Brian Schlain and Jan S. Krouwer: Multi-Factor Designs III. A Multi-factor Design With Unequal Spacing of Concentration Levels, (Abstract) Clin. Chem., 36, 1177 (1990).
  13. Jan S. Krouwer and Brian Schlain: A Method to Quantify Deviations From Nonlinearity. Clin. Chem., 39, 1227-8 (1993) (Abstract).
  14. Jan S. Krouwer: A Modification of EP10 to Include Interference Screening. Clin. Chem. 40, 1118-9 (1994) (Abstract).
  15. Jan S. Krouwer: Using capability indices to evaluate clinical laboratory assays, Clin. Chem. 34 S134 (1996) (Abstract).
  16. Donna S. Orvedahl, Andy Chan, Susan Degnan, Christopher Murphy, Sheryl Fennel, and Jan S. Krouwer: New generation of solid state sensors for electrochemical measurements. Clin. Chem. 34 S281 (1996) (Abstract).
  17. Eduard K.A. Winckers and Jan S. Krouwer: First clinical evaluation of the lactate sensor of the CCD 860. Clin. Chem. 34 S278-79 (1996) (Abstract).
  18. Jan S. Krouwer: Development of NCCLS consensus based EP10 software. Clin. Chem. 44, A61-62. (1998) (Abstract).
  19. Jan S. Krouwer: Adding fault trees to FMEAs to reduce risk in assay error. Clin. Chem. 50, A38. (2004) (Abstract).

Letters

  1. Jan S. Krouwer: Observations on Comparisons of Within-Run and Day-to-Day Precision, Clin. Chem., 27, 202 (1981), Clin. Chem., 27, 629, (1981) Publisher correction.
  2. Jan S. Krouwer and William N. Stewart: Correction of Precision Equations in NCCLS EP5-T, (Letter) Clin. Chem., 33, 1104 (1987).
  3. Jan S. Krouwer: The CV at The Detection Limit, (Letter) Clin. Chem., 35, 901 (1989).
  4. Brian Schlain and Jan S. Krouwer: Reply to Letter to Editor about: A Method to Quantify Deviations From Nonlinearity. Clin. Chem., 39, 1689-93, (1993), Clin. Chem., 40, 1785-6 (1994).
  5. Jan S. Krouwer and Katherine L. Monti: A Modification of EP10 to Include Interference Screening,. Clin. Chem., 41, 325-6 (1995).
  6. Jan S. Krouwer: How to Improve Total Error Modeling by Accounting for Error Sources Beyond Imprecision and Bias, Clin. Chem., 47, 1329-30 (2001).
  7. Jan S. Krouwer: Proposal to add an optional Recommendations section to Clinical Chemistry Abstracts. Clin. Chem., 48, 2292 (2002).
  8. Jan S. Krouwer: Certification is important - modeling and measurement are more important. Accred Qual Assur, 8, 368 (2003).
  9. Jan S. Krouwer: Problems with the NCEP (National Cholesterol Education Program) Recommendations for Cholesterol Analytical Performance. Arch Pathol Lab Med 127, 1249 (2003).
  10. Jan S. Krouwer: There is nothing wrong with the concept of a root cause. Int J Qual Health Care 2004;16:263.
  11. Jan S. Krouwer: Uncertainty Intervals Based on Deleting Data Are Not Useful Clin. Chem., 2006;52:1204-1205.
  12. Jan S. Krouwer: More on Reporting Medical Errors Clin. Chem. 2006;52:2120.
  13. Jan S. Krouwer: Comments on the editorial "On quality of a measurement result" Accred Qual Assur, 2007;12:263-264.
  14. Jan S. Krouwer: A recommended improvement for specifying and estimating serum creatinine performance. Clin Chem 2007;53:1715-1716.
  15. Jan S. Krouwer: Why Bland-Altman plots should use X, not (Y+X)/2 when X is a reference method. Statistics in Medicine, 2008;27:778-780.

Patents

  1. Jan S. Krouwer and Michael Lynch: Interference free transaminase assay. US Patent 4,575,488, June 25, 1982,  http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=/netahtml/search-bool.html&r=4&f=G&l=50&co1=AND&d=ptxt&s1=Krouwer.INZZ.&OS=IN/Krouwer&RS=IN/Krouwer
  2. John Benco, and Jan S. Krouwer: Method of Measuring pH, US Patent 6,355,158  March 12, 2002 http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=/netahtml/search-bool.html&r=1&f=G&l=50&co1=AND&d=ptxt&s1=Krouwer.INZZ.&OS=IN/Krouwer&RS=IN/Krouwer

Book Reviews

  1. Jan S. Krouwer: Book Review of Multivariate Interpretation of Clinical Laboratory Data, Clin. Chem., 34, 2187 (1988).
  2. Jan S. Krouwer: Book Review of Medical Uses of Statistics, Second Edition Clin. Chem., 39, 2214-5, (1993).
  3. Jan S. Krouwer: Book Review of Statistical Methods in Analytical Chemistry, Clin. Chem. 40, 955 (1994).

Book Chapters

  1. H.M.J. Goldschmidt and Jan S. Krouwer: Multi-factor Experimental Designs for Evaluations, in "Evaluation Methods in Laboratory Medicine," R. Haeckel, Ed., VCH, Weinheim, 1993.
  2. Jan S. Krouwer: Product Development for the Clinical Laboratory. in "Encyclopedia of Analytical Chemistry: Instrumentation and Applications", Robert A. Meyers, Ed., J. Wiley, 2000.

Standards

  1. Preliminary Evaluation of Quantitative Clinical Chemistry Laboratory Methods; Approved Guideline NCCLS EP10 A2, NCCLS, 940 West Valley Road Suite 1400 Wayne, PA., 2002.
  2. A Framework for NCCLS Evaluation Protocols; Proposed Guideline NCCLS EP19R, July, 2000, NCCLS, 940 West Valley Road Suite 1400 Wayne, PA., 2002.
  3. Evaluation of the linearity of quantitative analytical methods; Approved Guideline - NCCLS EP6A, NCCLS, 940 West Valley Road Suite 1400 Wayne, PA., 2003.

  4. Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline NCCLS EP21A, NCCLS, 940 West Valley Road Suite 1400 Wayne, PA., 2003.

  5. Jan S. Krouwer Total Error Estimator (Excel Add-in) EP21-A-C NCCLS EP21A, NCCLS, 940 West Valley Road Suite 1400 Wayne, PA., 2003.

  6. Risk Management Techniques to Identify and Control Laboratory Error Sources; Proposed Guideline—Second Edition EP18P2, NCCLS, 771 E. Lancaster Ave. Villanova, PA., 2007.

Presentations

  1. Jan S. Krouwer and Patricia E. Garrett: Evaluating Immunoassays: Where to Start and How to Finish with Confidence in Your Choice. Clinical Ligand Assay Society National Meeting May 1988 Washington, DC.

  2. Jan S. Krouwer and Patricia E. Garrett: Evaluating Immunoassays: Where to Start and How to Finish with Confidence in Your Choice. Clinical Ligand Assay Society National Meeting May 1989 Los Angeles, CA.

  3. Daniel W. Chan, Patricia E. Garrett, Jan S. Krouwer, and Marie Perlstein: Practical Immunoassay. AACC National Meeting, July 1989 New Orleans, LA.

  4. Jan S. Krouwer and Patricia E. Garrett: Evaluating Immunoassays: Where to Start and How to Finish with Confidence in Your Choice. Clinical Ligand Assay Society National Meeting May 1990 Philadelphia, PA.

  5. Jan S. Krouwer: Issues in Immunoassay Evaluation. NECLAS Meeting, January 1991 Boston, MA.

  6. Jan S. Krouwer and Patricia E. Garrett: Evaluating Immunoassays: Where to Start and How to Finish with Confidence in Your Choice. Clinical Ligand Assay Society National Meeting May 1991 Chicago, IL.

  7. Jan S. Krouwer: Total Error and Taguchi: Techniques to Improve Method Evaluation. XXI CAP Conference on Validation of Clinical Laboratory Methods and Instrumentation. October 1991, San Diego, CA.

  8. Jan S. Krouwer: Use of analytical goals by health care manufacturers. Frontiers in Laboratory Practice Research. October 1995, Atlanta, GA.

  9. Jan S. Krouwer Graphical Methods to Evaluate Laboratory Assays, Seminar Kwaliteitscontrole, February, 1996 Zeist, Holland

  10. Jan S. Krouwer and Keith McLain: Predicting and Improving Product Quality, Critical Care Business Leadership Forum, Coalition for Critical Care, September, 1998 Andover, MA.

  11. Jan S. Krouwer: Using Reliability Growth Management to Shorten Product Development Time, Society of Concurrent Engineering, September, 1998 Waltham, MA.

  12. Jan S. Krouwer: Graphical Evaluation of Immunoassays, CLAS, May, 1999, Philadelphia, PA.

  13. Jan S. Krouwer: Using a Learning Curve Approach to Reduce Laboratory Error, Quality Symposium, October, 2001, Antwerp, Belgium.

  14. Jan S. Krouwer: Improving Method Evaluations. NERCE, April, 2003, Boxborough, MA.

  15. Jan S. Krouwer: Reliability growth management in the medical diagnostics industry. IEEE, January, 2004, Chelmsford, MA.

  16. Jan S. Krouwer. Equivalent QC – Some Myths About Internal Monitoring Systems AACC Expert Access online presentation. April, 2005.

  17. Jan S. Krouwer: Managing Risk in Hospitals. NERCE, April, 2005, Boxborough, MA.

  18. Jan S. Krouwer: Reducing Risk of Lab Errors using Failure Mode Effects Analysis, NEAACC, May 2005, Waltham, MA.

  19. Jan S. Krouwer Reducing Risk of Lab Errors using Failure Mode Effects Analysis, AACC Workshop, July 2005 Orlando, FL.

  20. Jan S. Krouwer: Combining Fault Trees with FMEA to Reduce Medical Errors. IEEE November, 2005 Hopkinton, MA.

  21. Jan S. Krouwer: Manufacturers and the FDA - EP6, EP21, and other topics. April, 2007 Baltimore, MD.

  22. Steven R. Rakitin and Jan S. Krouwer Software verification and validation workshop (AAMI). June, 2007. Boston, MA

  23. Steven R. Rakitin and Jan S. Krouwer Software verification and validation workshop (AAMI). October, 2007. San Diego, MA.

  24. Jan S. Krouwer Practical FMEA (Quality in the spotlight) March, 2008. Antwerp, Belgium.

  25. Jan S. Krouwer EP18 and internal QC. Westgard QC Workshop, June 2008. Madison, Wisconsin.