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Licensed Unlicensed Requires Authentication Published by De Gruyter December 10, 2015

Performance criteria and quality indicators for the post-analytical phase

  • Laura Sciacovelli , Ada Aita , Andrea Padoan , Michela Pelloso , Giorgia Antonelli , Elisa Piva , Maria Laura Chiozza and Mario Plebani ORCID logo EMAIL logo

Abstract

Background: Quality indicators (QIs) used as performance measurements are an effective tool in accurately estimating quality, identifying problems that may need to be addressed, and monitoring the processes over time. In Laboratory Medicine, QIs should cover all steps of the testing process, as error studies have confirmed that most errors occur in the pre- and post-analytical phase of testing. Aim of the present study is to provide preliminary results on QIs and related performance criteria in the post-analytical phase.

Methods: This work was conducted according to a previously described study design based on the voluntary participation of clinical laboratories in the project on QIs of the Working Group “Laboratory Errors and Patient Safety” (WG-LEPS) of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).

Results: Overall, data collected highlighted an improvement or stability in performances over time for all reported indicators thus demonstrating that the use of QIs is effective in the quality improvement strategy. Moreover, QIs data are an important source for defining the state-of-the-art concerning the error rate in the total testing process. The definition of performance specifications based on the state-of-the-art, as suggested by consensus documents, is a valuable benchmark point in evaluating the performance of each laboratory.

Conclusions: Laboratory tests play a relevant role in the monitoring and evaluation of the efficacy of patient outcome thus assisting clinicians in decision-making. Laboratory performance evaluation is therefore crucial to providing patients with safe, effective and efficient care.


Corresponding author: Mario Plebani, Department of Laboratory Medicine, University-Hospital of Padua, Via Giustiniani, 2, 35128 Padua, Italy, Phone: +39 0498212792, Fax: +39 049663240, E-mail: .

References

1. Kallner A, McQueen M, Heuck C. The Stockholm Consensus Conference on quality specifications in laboratory medicine, 25–26 April 1999. Scand J Clin Lab Invest 1999;59:475–6.10.1080/00365519950185175Search in Google Scholar PubMed

2. Sandberg S, Fraser CG, Horvath AR, Jansen R, Jones G, Oosterhuis W, et al. Defining analytical performance specifications: Consensus Statement from the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine. Clin Chem Lab Med 2015;53:833–5.10.1515/cclm-2015-0067Search in Google Scholar PubMed

3. 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

4. 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

5. Plebani M, Carraro P. Mistakes in a stat laboratory: types and frequency. Clin Chem 1997;43:1348–513.10.1093/clinchem/43.8.1348Search in Google Scholar

6. 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 PubMed

7. UNI EN ISO 15189:2013. Medical laboratories – Requirements for quality and competence. Geneva, Switzerland: International Organization for Standardization, 2013.Search in Google Scholar

8. Institute of Medicine. To err is human: building a safer health system. Washington, DC: National Academy Press, 2000.Search in Google Scholar

9. 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 PubMed

10. 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

11. Plebani M, Astion ML, Barth JH, Chen W, de Oliveira Galoro CA, Escuer MI, et al. Harmonization of quality indicators in laboratory medicine. A preliminary consensus. Clin Chem Lab Med 2014;52:951–8.10.1515/cclm-2014-0142Search in Google Scholar PubMed

12. Plebani M, Sciacovelli L, Aita A, Pelloso M, Chiozza ML. Performance criteria and quality indicators for the pre-analytical phase. Clin Chem Lab Med 2015;53:943–8.10.1515/cclm-2014-1124Search in Google Scholar PubMed

13. Valestein P. Laboratory turnaround time. Am J Clin Pathol 1196;105:676–88.10.1093/ajcp/105.6.676Search in Google Scholar PubMed

14. Kilgore ML, Steindel SJ, Smith JA. Evaluating stat testing options in an academic health center: therapeutic turnaround time and staff satisfaction. Clin Chem 1998;44:1597–603.10.1093/clinchem/44.8.1597Search in Google Scholar

15. Hawkins RC. Laboratory turnaround time. Clin Biochem Rev 2007;28:179–1949.Search in Google Scholar

16. Piva E, Sciacovelli L, Laposata M, Plebani M. Assessment of critical values policies in Italian institutions: comparison with the US situation. Clin Chem Lab Med 2010;48:461–8.10.1515/CCLM.2010.096Search in Google Scholar PubMed

17. Dighe AS, Sodeberg BI, Laposata M. Narrative interpretation for clinical laboratory interpretations. Am J Clin Pathol 2001;116:S123–8.10.1309/M6T4-91H2-2KYB-EEK5Search in Google Scholar PubMed

18. Macmillian DH, Sodeberg BI, Laposata M. Regulations regarding reflexive testing and narrative interpretations in laboratory medicine. Am J Clin Pathol 2001;116:S129–32.10.1309/RG7D-YE9L-3XGT-DKT6Search in Google Scholar PubMed

19. Kratz A, Sodeberg BI. The generation of narrative interpretations in laboratory medicine. Am J Clin Pathol 2001;116:S133–40.10.1309/F9B6-33HK-8B0B-8LNMSearch in Google Scholar PubMed

20. Plebani M. Interpretative commenting: a tool for improving the laboratory-clinical interface. Clin Chim Acta 2009;404:46–51.10.1016/j.cca.2009.03.012Search in Google Scholar PubMed

21. Lim EM, Sikaris KA, Gill J, Calleja J, Hickman PE, Beilby J, et al. Quality assessment of interpretative commenting in clinical chemistry. Clin Chem 2004;50:632–7.10.1373/clinchem.2003.024877Search in Google Scholar PubMed

22. Laposata ME, Laposata M, Van Cott EM, Buchner DS, Kashalo MS, Dighe AS. Physician survey of a laboratory medicine interpretive service and evaluation of the influence of interpretations on laboratory test ordering. Arch Pathol Lab Med 2004;128:1424–7.10.5858/2004-128-1424-PSOALMSearch in Google Scholar PubMed

23. Zarbo RJ, Nakhleh RE, Walsh M. Customer satisfaction in anatomic pathology: a College of American Pathologists Q-Probes study of 30656 physician surveys from 94 laboratories. Arch Pathol Lab Med 2003;127:23–9.10.5858/2003-127-23-CSIASearch in Google Scholar PubMed

24. Westgard JO. Six sigma quality, design and control. Madison, WI: Westgard QC, 2006.Search in Google Scholar

25. Burnett D. A practical guide to ISO 15189 in Laboratory medicine. London: Association for Clinical Biochemistry and Laboratory Medicine, 2013.Search in Google Scholar

26. Fraser CG, Hylton Petersen P, Libeer J-C, Ricos C. Proposal for setting generally applicable quality goals solely based on biology. Ann Clin Biochem 1997;34:1–8.10.1177/000456329703400103Search in Google Scholar PubMed

27. Ricos C, Garcia-Victoria M, de la Fuente B. Quality indicators and specifications for the extra-analytical phases in clinical laboratory management. Clin Chem Lab Med 2004;42:578–82.10.1515/CCLM.2004.100Search in Google Scholar PubMed

28. Novis DA, Walsh MK, Dale JC, Howanitz PJ. Continuous monitoring of stat and routine outlier turnaround times: two College of American Pathologists Q-Track monitors in 2941 hospitals. Arch Pathol Lab Med 2004;128:621–6.10.5858/2004-128-621-CMOSARSearch in Google Scholar PubMed

29. Steindel SJ, Novis DA. Using outlier event to monitor test turnaround time: a College of American Pathologists Q-Probes study in 496 laboratories. Arch Pathol Lab Med 1999;123:607–14.10.5858/1999-123-0607-UOETMTSearch in Google Scholar PubMed

30. Piva E, Pelloso M, Penello L, Plebani M. Laboratory critical values: automated notification supports effective clinical decision making. Clin Biochem 2014;47:1163–8.10.1016/j.clinbiochem.2014.05.056Search in Google Scholar PubMed

31. Piva E, Sciacovelli L, Zaninotto M, Laposata M, Plebani M. Evaluation of effectiveness of a computerized notification system for reporting critical values. Am J Clin Pathol 2009;131:432–41.10.1309/AJCPYS80BUCBXTUHSearch in Google Scholar PubMed

32. Sikaris K. Performance criteria of the post-analytical phase. Clin Chem Lab Med 2015;35:949–58.10.1515/cclm-2015-0016Search in Google Scholar PubMed

Received: 2015-9-14
Accepted: 2015-11-1
Published Online: 2015-12-10
Published in Print: 2016-7-1

©2016 by De Gruyter

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