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Validation of Hemostasis Assays, Analyzers, and Reagents

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Laboratory Hemostasis

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Abstract

A key responsibility of the laboratory director is to assure that information and services provided by the laboratory meet the needs of its users and conform to established regulations and standards even before clinical specimens are tested and results are generated for patient care. The process of providing this assurance is commonly referred to as validation.

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References

  1. Wikipedia. Validation. http://en.wikipedia.org/wiki/Validation. Accessed 31 Mar 2014.

  2. Gawande A. The checklist manifesto: how to get things right. New York: Metropolitan Books; 2010.

    Google Scholar 

  3. Ely JW, Graber ML, Croskerry P. Checklists to reduce diagnostic errors. Acad Med. 2011;86:307–13.

    Article  PubMed  Google Scholar 

  4. Clinical and Laboratory Standards Institute. Laboratory instrument implementation, verification, and maintenance; approved guideline, document GP31-A. Wayne: CLSI; 2009.

    Google Scholar 

  5. College of American Pathologists. Hematology and coagulation checklist. Northfield: CAP; 2013.

    Google Scholar 

  6. Code of Federal Regulations. Standard: calibration and calibration verification procedures. 42 CFR 493.1255; 2013.

    Google Scholar 

  7. Clinical and Laboratory Standards Institute. Statistical quality control for quantitative measurements: principles and definitions; approved guideline. 3rd ed, document C24-A3. Wayne: CLSI; 2006.

    Google Scholar 

  8. Clinical and Laboratory Standards Institute. Defining, establishing, and verifying reference intervals in the clinical laboratory; approved guideline. 3rd ed, document EP28-A3C. Wayne: CLSI; 2008.

    Google Scholar 

  9. Clinical and Laboratory Standards Institute. One-stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; approved guideline. 2nd ed, document H47-A2. Wayne: CLSI; 2008.

    Google Scholar 

  10. Clinical and Laboratory Standards Institute. Laboratory quality control based on risk management; approved guideline, document EP23-A. Wayne: CLSI; 2011.

    Google Scholar 

  11. Person NB. Developing risk-based quality control plans: an overview of CLSI EP23-A. Clin Lab Med. 2013;33:15–26.

    Article  PubMed  Google Scholar 

  12. Bock BJ, Dolan CT, Miller GC, et al. The data warehouse as a foundation for population-based reference intervals. Am J Clin Pathol. 2003;120:662–70.

    Article  PubMed  Google Scholar 

  13. Plapp FV, Essmyer CE, Byrd AB, et al. How to successfully influence laboratory test utilization. Clin Leadersh Manag Rev. 2000;14:253–60.

    PubMed  CAS  Google Scholar 

  14. Panteghini M, Ceriotti F. Obtaining reference intervals traceable to reference measurement systems: is it possible, who is responsible, what is the strategy? Clin Chem Lab Med. 2011;50:813–7.

    PubMed  Google Scholar 

  15. Clinical and Laboratory Standards Institute. Measurement procedure comparison and bias estimation using patient samples; approved guideline. 3rd ed, document EP09-A3. Wayne: CLSI; 2013.

    Google Scholar 

  16. Clinical and Laboratory Standards Institute. Preliminary evaluation of quantitative clinical laboratory measurement procedures; approved guideline. 3rd ed, document EP10-A3. Wayne: CLSI; 2006.

    Google Scholar 

  17. Clinical and Laboratory Standards Institute. User verification of performance for precision and trueness; approved guideline. 2nd ed, document EP15-A2. Wayne: CLSI; 2005.

    Google Scholar 

  18. Clinical and Laboratory Standards Institute. Estimation of total analytical error for clinical laboratory methods; approved guideline, document EP21-A. Wayne: CLSI; 2003.

    Google Scholar 

  19. Clinical and Laboratory Standards Institute. Evaluation of precision performance of quantitative measurement methods; approved guideline. 2nd ed, document EP05-A2. Wayne: CLSI; 2004.

    Google Scholar 

  20. Gardiner C, Kitchen S, Dauer RJ, et al. Recommendations for evaluation of coagulation analyzers. Lab Hematol. 2005;12:32–8.

    Article  Google Scholar 

  21. Passing H, Bablok W. A new biometrical procedure for testing the equality of measurements from two different analytical methods. J Clin Chem Clin Biochem. 1983;21:709–20.

    PubMed  CAS  Google Scholar 

  22. Dewitte K, Fierens C, Stöckl D, et al. Application of the Bland-Altman plot for interpretation of method-comparison studies: a critical investigation of its practice. Clin Chem. 2002;48:799–801.

    PubMed  CAS  Google Scholar 

  23. Critchfield CF, Bennett ST. Calibration verification of the International Normalized Ratio. Am J Clin Pathol. 1996;106:786–94.

    PubMed  CAS  Google Scholar 

  24. Clinical and Laboratory Standards Institute. Procedures for validation of INR and local calibration of PT/INR systems; approved guideline, document H54-A. Wayne: CLSI; 2005.

    Google Scholar 

  25. Cary ER, Fink LM, Stokes SL, et al. Selection and implementation for coagulation instruments/reagents in a multiple hospital/clinic network. Blood Coagul Fibrinolysis. 2000;11:599–608.

    Article  PubMed  CAS  Google Scholar 

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Author information

Authors and Affiliations

  1. Pathology Department, Intermountain Healthcare Urban Central Region, Salt Lake City, UT, USA

    Sterling T. Bennett MD, MS

  2. Pathology Department, University of Utah Health Sciences Center, Salt Lake City, UT, USA

    Sterling T. Bennett MD, MS

  3. Intermountain Healthcare Central Laboratory, Salt Lake City, UT, USA

    Sterling T. Bennett MD, MS

Authors
  1. Sterling T. Bennett MD, MS
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Correspondence to Sterling T. Bennett MD, MS .

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Bennett, S.T. (2015). Validation of Hemostasis Assays, Analyzers, and Reagents. In: Laboratory Hemostasis. Springer, Cham. https://doi.org/10.1007/978-3-319-08924-9_4

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  • DOI: https://doi.org/10.1007/978-3-319-08924-9_4

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-08923-2

  • Online ISBN: 978-3-319-08924-9

  • eBook Packages: MedicineMedicine (R0)

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