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Licensed Unlicensed Requires Authentication Published by De Gruyter August 12, 2014

Use of quality indicators to compare point-of-care testing errors in a neonatal unit and errors in a STAT central laboratory

  • Miguel Cantero EMAIL logo , Maximino Redondo , Eva Martín , Gonzalo Callejón and María Luisa Hortas

Abstract

Background: Point-of-care testing (POCT), like other laboratory tests, can be affected by errors throughout the total testing process. To evaluate quality error rates, the use of quality indicators (QIs) is recommended; however, little information is available on the quality error rate associated with POCT. The objective of this study was to investigate quality error rates related to POCT and compare them with central laboratory (CL) testing.

Methods: We studied standardized QIs for POCT in comparison to CL testing. We compared error rates related to requests, collection, and handling of samples and results from external quality assessment program (EQAP) and internal quality control (IQC).

Results: The highest difference between POCT and CL testing was observed for QI related to patient identification, 45.3% vs. 0.02% (p<0.001). Regarding specimen collection and handling, the QI related to samples without results was also higher in POCT than in CL testing, 15.8% vs. 3.3% (p<0.001). For the QI related to insufficient sample volume, we obtained 2.9% vs. 0.9% (p=0.27). Unlike QIs for the preanalytical phase, QIs for the analytical phase had better results in POCT than CL testing. We obtained 8.3% vs. 16.6% (p=0.13) for QI related to unacceptable results in EQAP and 0.8% vs. 22.5% (p<0.001) for QI related to unacceptable results in IQC.

Conclusions: Our results show that the preanalytical phase remains the main problem in POCT like in CL testing and that monitoring of quality indicators is a very valuable tool in reducing errors in POCT.


Corresponding author: Miguel Cantero, Clinical Laboratories Area, Agencia Sanitaria Costa del Sol, Autovía A7, km 187, 29603 Marbella, Málaga, Spain, Phone: +34 951976190, E-mail:

Acknowledgments

We thank to M. Lucía Alcalde Lorenzo for providing language help.

Author contributions

All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

Financial support: None declared.

Employment or leadership: None declared.

Honorarium: None declared.

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

References

1. International Organization for Standardization. ISO 22870:2006: point-of-care testing (POCT) – requirements for quality and competence. Geneva, Switzerland: International Organization for Standardization, 2006.Search in Google Scholar

2. Nichols JH. Reducing medical errors at the point of care. Labmedicine 2005;36:275–7.10.1309/NXXWJ31PWFHT7L1QSearch in Google Scholar

3. Jones BA, Meier FA. Patient safety in point-of-care testing. Clin Lab Med 2004;24:997–1022.10.1016/j.cll.2004.06.001Search in Google Scholar

4. Plebani M. Does POCT reduce the risk of error in laboratory testing? Clin Chim Acta 2009;404:59–64.10.1016/j.cca.2009.03.014Search in Google Scholar

5. O’Kane MJ, McManus P, McGowan N, Lynch PL. Quality error rates in point-of-care testing. Clin Chem 2011;57:1267–71.10.1373/clinchem.2011.164517Search in Google Scholar

6. Plebani M, Carraro P. Mistakes in a stat laboratory: types and frequency. Clin Chem 1997;43:1348–51.10.1093/clinchem/43.8.1348Search in Google Scholar

7. Carraro P, Plebani M. Errors in a stat laboratory: types and frequencies 10 years later. Clin Chem 2007;53:1338–42.10.1373/clinchem.2007.088344Search in Google Scholar

8. Briedigkeit L, Müller-Plathe O, Schlebusch H, Ziems J. Recommendations of the German Working Group on medical laboratory testing (AML) on the introduction and quality assurance of procedures for point-of-care testing (POCT) in hospitals. Clin Chem Lab Med 1999;37:919–25.10.1515/CCLM.1999.136Search in Google Scholar

9. Near to patient or point of care testing. The Joint Working Group on Quality Assurance. Clin Lab Haematol 2000;22:185–8.Search in Google Scholar

10. Ehrmeyer SS, Laessing RH. Regulatory requirements CLIA’88, JCAHO, CAP. for decentralized testing. Am J Clin Pathol 1995;4:S40–9.Search in Google Scholar

11. Jacobs E, Hinson KA, Tolnai J, Simson E. Implementation, management and continuous quality improvement of point-of-care testing in an academic health care setting. Clin Chim Acta 2001;307:49–59.10.1016/S0009-8981(01)00432-6Search in Google Scholar

12. Nichols JH, Christenson RH, Clarke W, Gronowski A, Hammett-Stabler CA, Jacobs E, et al. National Academy of Clinical Biochemistry. Executive summary. The National Academy of Clinical Biochemistry Laboratory Medicine Practice Guideline: evidence-based practice for point-of-care testing. Clin Chim Acta 2007;379:14–28.10.1016/j.cca.2006.12.025Search in Google Scholar PubMed

13. Hawkins R. Managing the pre- and post-analytical phases of the total testing process. Ann Lab Med 2012;32:5–16.10.3343/alm.2012.32.1.5Search in Google Scholar PubMed PubMed Central

14. Bonini P, Plebani M, Ceriotti F, Rubboli F. Errors in laboratory medicine. Clin Chem 2002;48:691–8.10.1093/clinchem/48.5.691Search in Google Scholar

15. Sciacovelli L, Plebani M. The IFCC Working Group on laboratory errors and patient safety. Clin Chim Acta 2009;404:79–85.10.1016/j.cca.2009.03.025Search in Google Scholar

16. Sciacovelli L, O’Kane M, Skaik YA, Caciagli P, Pellegrini C, Da Rin G, et al. IFCC WG-LEPS. Quality indicators in laboratory medicine: from theory to practice. Preliminary data from the IFCC Working Group Project “Laboratory Errors and Patient Safety”. Clin Chem Lab Med 2011;49:835–44.Search in Google Scholar

17. Hortas ML, Montiel N, Redondo M, Medina A, Contreras E, Cortés C, et al. Quality assurance of point-of-care testing in the Costa del Sol Healthcare Area (Marbella, Spain). Clin Chim Acta 2001;307:113–8.10.1016/S0009-8981(01)00441-7Search in Google Scholar

18. Ehrmeyer SS. Plan for quality to improve patient safety at the point of care. Ann Saudi Med 2011;31:342–6.10.4103/0256-4947.83203Search in Google Scholar PubMed PubMed Central

19. Shephard MD, Mazzachi BC, Watkinson L, Shephard AK, Laurence C, Gialamas A, et al. Evaluation of a training program for device operators in the Australian Government’s Point of Care Testing in General Practice Trial: issues and implications for rural and remote practices. Rural Remote Health 2009;9:1189.10.22605/RRH1189Search in Google Scholar

20. Lewandrowski K, Gregory K, Macmillan D. Assuring quality in point-of-care testing: evolution of technologies, informatics, and program management. Arch Pathol Lab Med 2011;135:1405–14.10.5858/arpa.2011-0157-RASearch in Google Scholar PubMed

21. Recommendation for the use of analytical quality specifications. Revision 02 (2014, March). Available from: http://www.seqc.es/. Accessed on March 17, 2014.Search in Google Scholar

22. Ricós C, Alvarez V, Cava F, Garcia-Lario JV, Hernandez A, Jimenez CV, et al. Current databases on biologic variation: pros, cons and progress. Scand J Clin Lab Invest 1999;59: 491–500.10.1080/00365519950185229Search in Google Scholar PubMed

23. Biological variation database, and quality specifications for imprecision, bias and total error. The 2012 update. Available from: http://www.seqc.es/. Accessed on March 12, 2012.Search in Google Scholar

24. Fraser CG, Hyltoft Petersen P, Libeer JC, Ricos C. Proposals for setting generally applicable quality goals solely based on biology. Ann Clin Biochem 1997;34:8–12.10.1177/000456329703400103Search in Google Scholar PubMed

25. The Joint Commission. National patient safety goals effective January 1, 2013. Available from: http://www.jointcommission.org/assets/1/18/NPSG_Chapter_Jan2013_HAP.pdf. Accessed on March 15, 2013.Search in Google Scholar

26. Snyder SR, Favoretto AM, Derzon JH, Christenson RH, Kahn SE, Shaw CS, et al. Effectiveness of barcoding for reducing patient specimen and laboratory testing identification errors: a Laboratory Medicine Best Practices systematic review and meta-analysis. Clin Biochem 2012, 45:988–98.10.1016/j.clinbiochem.2012.06.019Search in Google Scholar PubMed PubMed Central

27. Plebani M. The detection and prevention of errors in laboratory medicine. Ann Clin Biochem 2010;47:101–10.10.1258/acb.2009.009222Search in Google Scholar PubMed

28. Lippi G, Chance JJ, Church S, Dazzi P, Fontana R, Giavarina D, et al. Preanalytical quality improvement: from dream to reality. Clin Chem Lab Med 2011;49:1113–26.10.1515/CCLM.2011.600Search in Google Scholar PubMed

29. Bhat V, Tiwari M, Chavan P, Kelkar R. Analysis of laboratory sample rejections in the pre-analytical stage at an oncology center. Clin Chim Acta 2012;413:1203–6.10.1016/j.cca.2012.03.024Search in Google Scholar PubMed

30. Guimarães AC, Wolfart M, Brisolara ML, Dani C. Causes of rejection of blood samples handled in the clinical laboratory of a University Hospital in Porto Alegre. Clin Biochem 2012;45:123–6.10.1016/j.clinbiochem.2011.10.009Search in Google Scholar PubMed

31. Clinical and Laboratory Standards Institute. Laboratory quality control based on risk management; approved guideline. CLSI document EP23-A. Wayne, PA: Clinical and Laboratory Standards Institute, 2011.Search in Google Scholar

32. Westgard JO. Perspectives on quality control, risk management, and analytical quality management. Clin Lab Med 2013;33:1–14.10.1016/j.cll.2012.10.003Search in Google Scholar PubMed

33. Person NB. Developing risk-based quality control plans: an overview of CLSI EP23-A. Clin Lab Med 2013;33:15–26.10.1016/j.cll.2012.11.003Search in Google Scholar PubMed

Received: 2013-12-10
Accepted: 2014-7-8
Published Online: 2014-8-12
Published in Print: 2015-2-1

©2015 by De Gruyter

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