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Sicherstellung der Qualität bei der POCT-Diagnostik durch Risikomanagement

  • James H. Nichols

Zusammenfassung

Das Qualitätsmanagement der POCT-Diagnostik muss mit einem Fehlerrisikomanagement einhergehen. Dieses Kapitel erläutert häufige Fehlerquellen bei der POCT-Diagnostik sowie die Rolle der Qualitätskontrolle im Sinne der Kontrolle analytischer Fehler. Darüber betont das Kapitel, dass Risikomanagement zum Gesamtprozess der Qualitätssicherung gehört. Dabei bieten individualisierte Qualitätskontrollpläne (IQCP) die Möglichkeit, in multidisziplinären Teams die Schwächen und Grenzen des diagnostischen Prozesses beim POCT besser zu verstehen. Ein IQCP kann Fehler verhindern, Kosten sparen, die Effizienz der Mitarbeiter erhöhen und die Patientenversorgung mit POCT verbessern.

Literatur

  1. 1.
    Alreja G, Setia N, Nichols J, Pantanowitz L (2011) Reducing patient identification errors related to glucose point- of-care testing. J Pathol Inform 2: 22. www.ncbi.nlm.nih.gov/pmc/articles/PMC3097526/
  2. 2.
    Balogh EP, Miller BT, Ball JR (2015) Improving Diagnosis in Healthcare. Committee on Diagnostic Error in Health Care; Board on Health Care Services; Institute of Medicine; The National Academies of Sciences, Engineering, and Medicine. Washington, DC. http://www.nap.edu/catalog/21794/improving-diagnosis-in-health-care
  3. 3.
    Bonini P, Plebani M, Ceriotti F, Rubboli F (2002) Errors in Laboratory Medicine. Clin Chem 48: 691-698Google Scholar
  4. 4.
    CDC (2015) Ready? Set? Test! Centers for Disease Control and Prevention, Center for Surveillance, Epidemiology, and Laboratory Services, Division of Laboratory Systems. Atlanta, GA. http://wwwn.cdc.gov/clia/Resources/Waived Tests/pdf/15_255581-A_Stang_RST_Booklet_508Final.pdf
  5. 5.
    Clinical and Laboratory Standards Institute (2011) EP23-A: Laboratory Quality Control Based on Risk Management; Approved Guideline. CLSI, Wayne, PAGoogle Scholar
  6. 6.
    CMS (2015) State Operations Manual, Appendix C – Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services. Rev. 147. Centers for Medicare and Medicaid Services. Washington, DC. www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Interpretive_Guidelines_for_Laboratories.html
  7. 7.
    Davis K, Schoenbaum SC, Collins KS, Tenney K, Hughes DL, Audet A-MJ (2002) Room for Improvement: Patients Report on the Quality of Their Health Care. The Commonwealth Fund. http://www.commonwealthfund.org/publications/fund-reports/2002/apr/room-for-improvement--patients-report-on-the-quality-of-their-health-care
  8. 8.
    FDA (2010) Use of Fingerstick Devices on More Than One Person Poses Risk for Transmitting Bloodborne Pathogens. U.S. Food and Drug Administration. Washington, D.C. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm
  9. 9.
    FDA (2015) Useful Tips to Increase Accuracy and Reduce Errors in Test Results from Glucose Meters, U.S. Food and Drug Administration, Washington, D.C. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm109519.htm
  10. 10.
    International Organization for Standardization (2014) ISO/IEC Guide 51. Safety Aspects – Guidelines for their Inclusion in Standards. ISO, Genf, SchweizGoogle Scholar
  11. 11.
    Kohn LT, Corrigan JM, Donaldson MS (1999) To Err is Human: Building a Safer Health System. National Academy Press, Washington, DCGoogle Scholar
  12. 12.
    Leape LL (1994) Error in medicine. JAMA 272:1851–1857Google Scholar
  13. 13.
    Leape LL, Brennan TA, Laird N, Lawthers AG, Localio AR, Barnes BA, Hebert L, Newhouse JP, Weiler PC, Hiatt H (1991) The Nature of Adverse Events in Hospitalized Patients. Results of the Harvard Medical Practice Study II. N Eng J Med 324:377–384Google Scholar
  14. 14.
    O’Kane MJ, McManus P, McGowen N, Lynch PLM (2011) Quality Error Rates in Point-of-Care Testing. Clin Chem 9:1267–1271Google Scholar
  15. 15.
    Quality Interagency Coordination Task For (2000) Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact. A Report of the Quality Interagency Coordination Task Force (QuIC) to the President. Department of Health and Human Services, Agency for Healthcare Research and Quality. Washington DC, August 2000. http://archive.ahrq.gov/quic/report/mederr4.htm
  16. 16.
    Reason J (2000) Human Error: Models and Management. BMJ 320:768–770Google Scholar
  17. 17.
    Rust MJ, Carlson NA, Nichols JH (2012) A thermo-modulating container for transport and storage of glucose meters in a cold weather environment. Point of Care 11(3): 157–160Google Scholar
  18. 18.
    Silverman BC, Humbertson SK, Stem JE, Nichols JH (2000) Operational errors cause inaccurate glucose results. Diabetes Care 23:429–430Google Scholar
  19. 19.
    Silverstein MD (2003) An Approach to Medical Errors and Patient Safety in Laboratory Services. A White Paper Prepared for the Quality Institute Meeting, Making the Laboratory a Partner in Patient safety. Division of Laboratory Systems, Centers for Disease control and Prevention. Atlanta, GA. http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.615.4936&rep=rep1&type=pdf
  20. 20.
    Vanhaeren S, Duport C, Magneney M, Dumé L, Dumenil AS, Doucet-Populaire F, Decousser JW (2011) Bacterial contamination of glucose test strips: Not to be neglected. Am J Infect Control 39:611–613Google Scholar

Copyright information

© Springer-Verlag GmbH Deutschland 2017

Authors and Affiliations

  • James H. Nichols
    • 1
  1. 1.4918D TVC (The Vanderbilt Clinic)Vanderbilt University School of MedicineNashvilleUSA

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