• 1. Berk J, Berk S. Total quality management. Implementing continuous improvement. New York: Sterling Publishing Co, 1993.

  • 2. Westgard JO, Klee GG. Quality management. In:Burtis CA, Ashwood ER, Bruns DE, eds. Tietz textbook of clinical chemistry and molecular diagnostics. 4th ed. Philadelphia: WB Saunders Co, 2006;485529.

    • Search Google Scholar
    • Export Citation
  • 3. GLP and ISO/IEC 17025. Available at: www.labcompliance.com/tutorial/iso17025/default.aspx?sm=d_f. Accessed Jan 11, 2011.

  • 4. CLIA-88 proficiency testing (PT) criteria for acceptable performance. Fed Reg 1992; 57:70027186.

  • 5. US Department of Health and Human Services. FDA. 21CFR part 820: medical devices. Current good manufacturing practice (CGMP). Fed Reg 1996; 61:5260152662.

    • Search Google Scholar
    • Export Citation
  • 6. Lasky FD, Boser RB. Designing in quality through design control: a manufacturer's perspective. Clin Chem 1997; 43:866872.

  • 7. American Society of Veterinary Clinical Pathologists. Quality assurance guidelines. Available at: www.asvcp.org/pubs/qas/newQas/index.cfm. Accessed Jan 11, 2011.

    • Search Google Scholar
    • Export Citation
  • 8. Flatland B, Freeman KP, Friedrichs KR, et al. ASVCP quality assurance guidelines: control of general analytical factors in veterinary laboratories. Vet Clin Pathol 2010; 39:264277.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 9. Wiegers AL. Laboratory quality considerations for veterinary practitioners. J Am Vet Med Assoc 2004; 225:13861390.

  • 10. Wiegers AL. The age of competence: an update on the international laboratory accreditation scene for veterinary testing laboratories. J Vet Diagn Invest 2002; 14:8996.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 11. Mitzner BT. Guest editorial: it's time for in-house quality assurance. J Am Anim Hosp Assoc 2002; 38:1213.

  • 12. Freeman KP, Evans EW, Lester S. Quality control for in-hospital veterinary laboratory testing. J Am Vet Med Assoc 1999; 215:928929.

    • Search Google Scholar
    • Export Citation
  • 13. Freeman KP, Gruenwaldt J. Quality control validation in veterinary laboratories. Vet Clin Pathol 1999; 28:150155.

  • 14. Farr AJ, Freeman KP. Quality control validation, application of sigma metrics, and performance comparison between two biochemistry analyzers in a commercial veterinary laboratory. J Vet Diagn Invest 2008; 20:536544.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 15. Sacchini F, Freeman KP. Quality documentation challenges for veterinary clinical pathology laboratories. J Vet Diagn Invest 2008; 20:266273.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 16. Farr AJ, Freeman KP. Quality requirements, QC validation and sigma metrics for veterinary laboratories. Available at: www.westgard.com/quality-requirements-for-veterinary-labs.htm. Accessed Jan 25, 2011.

    • Search Google Scholar
    • Export Citation
  • 17. KP Freeman. QC validation in veterinary laboratories. Available at: www.westgard.com/guest13.htm. Accessed Jan 25, 2011.

  • 18. Jensen AL, Kjelgaard-Hansen M. Method comparison in the clinical laboratory. Vet Clin Pathol 2006; 35:276286.

  • 19. Rishniw M, Pion PD, Maher T. The quality of veterinary in-clinic and reference laboratory biochemistry testing. Vet Clin Pathol 2012; 41:92109.

    • Search Google Scholar
    • Export Citation
  • 20. Royal College of Veterinary Surgeons. Practice standards scheme manual. Available at: www.rcvs.org.uk/Shared_ASP_Files/UploadedFiles/rcvs/92E4DD8C-4A8F-4B33-89A6-4D4F-C447111C_pss_manual_final.pdf. Accessed Jan 14, 2011.

    • Search Google Scholar
    • Export Citation
  • 21. College of Veterinarians of Ontario. The College of Veterinarians of Ontario Guideline: ordering, performing and interpreting laboratory tests in veterinary clinical practice. Available at: www.cvo.org/uploadedattachments/Laboratorytestguidelines.pdf. Accessed Sep 1, 2010.

    • Search Google Scholar
    • Export Citation
  • 22. American Animal Hospital Association website. Standard of accreditation. Available at: www.aahanet.org/accreditation/index.aspx. Accessed Sep 1, 2010.

    • Search Google Scholar
    • Export Citation
  • 23. American Association of Veterinary Laboratory Diagnosticians website. AAVLD accreditation requirements. Available at: data.memberclicks.com/site/aavld/Requirements%20v5%200%2009-16-10.pdf. Accessed Jan 15, 2011.

    • Search Google Scholar
    • Export Citation
  • 24. Kjelgaard-Hansen M, Jensen AL. Subjectivity in defining quality specifications for quality control and test validation. Vet Clin Pathol 2010; 39:134135.

    • Search Google Scholar
    • Export Citation
  • 25. Dhatt GS, Agarwal MM, Bishawi B, et al. Implementing the Stockholm Conference hierarchy of objective quality criteria in a routine laboratory. Clin Chem Lab Med 2007; 45:549552.

    • Search Google Scholar
    • Export Citation
  • 26. Westgard JO. Basic method validation. 3rd ed. Madison, Wis: Westgard QC Inc, 2008;130131.

  • 27. Krouwer JS. Setting performance goals and evaluating total analytical error for diagnostic assays. Clin Chem 2002; 48:919927.

  • 28. Parvin CA. Assessing the impact of the frequency of quality control testing on the quality of reported patient results. Clin Chem 2008; 54:20492054.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 29. Parvin CA, Robbins S III. Evaluation of the performance of randomized versus fixed time schedules for quality control procedures. Clin Chem 2007; 53:575580.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 30. Westgard JO, Barry PL, Hunt MR, et al. A multi-rule Shewhart chart for quality control in clinical chemistry. Clin Chem 1981; 27:493501.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 31. Westgard JO, Groth T, Aronsson T, et al. Performance characteristics of rules for internal quality control: probabilities for false rejection and error detection. Clin Chem 1977; 23:18571867.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 32. Westgard JO. Charts of operational process specifications (“OPSpecs charts”) for assessing the precision, accuracy, and quality control needed to satisfy proficiency testing performance criteria. Clin Chem 1992; 38:12261233, 12451250.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 33. Klee GG. Establishment of outcome-related analytic performance goals. Clin Chem 2010; 56:714722.

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Current quality assurance concepts and considerations for quality control of in-clinic biochemistry testing

Sally LesterPilchuck Veterinary Hospital, 11308 92nd St, Snohomish, WA 98290.

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K. E. HarrUrika LLC, 8712 53rd Pl W, Mukilteo, WA 98275.

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Abstract

Quality assurance is an implied concept inherent in every consumer's purchase of a product or service. In laboratory testing, quality assurance encompasses preanalytic (sampling, transport, and handling prior to testing), analytic (measurement), and postanalytic (reporting and interpretation) factors. Quality-assurance programs require that procedures are in place to detect errors in all 3 components and that the procedures are characterized by both documentation and correction of errors. There are regulatory bodies that provide mandatory standards for and regulation of human medical laboratories. No such regulations exist for veterinary laboratory testing. The American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards Committee was formed in 1996 in response to concerns of ASVCP members about quality assurance and quality control in laboratories performing veterinary testing. Guidelines for veterinary laboratory testing have been developed by the ASVCP. The purpose of this report was to provide an overview of selected quality-assurance concepts and to provide recommendations for quality control for in-clinic biochemistry testing in general veterinary practice.

Abstract

Quality assurance is an implied concept inherent in every consumer's purchase of a product or service. In laboratory testing, quality assurance encompasses preanalytic (sampling, transport, and handling prior to testing), analytic (measurement), and postanalytic (reporting and interpretation) factors. Quality-assurance programs require that procedures are in place to detect errors in all 3 components and that the procedures are characterized by both documentation and correction of errors. There are regulatory bodies that provide mandatory standards for and regulation of human medical laboratories. No such regulations exist for veterinary laboratory testing. The American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards Committee was formed in 1996 in response to concerns of ASVCP members about quality assurance and quality control in laboratories performing veterinary testing. Guidelines for veterinary laboratory testing have been developed by the ASVCP. The purpose of this report was to provide an overview of selected quality-assurance concepts and to provide recommendations for quality control for in-clinic biochemistry testing in general veterinary practice.

Contributor Notes

Address correspondence to Dr. Rishniw (mark@vin.com).