Jump to ContentJump to Main Navigation
Show Summary Details
More options …

Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter


IMPACT FACTOR 2018: 3.638

CiteScore 2018: 2.44

SCImago Journal Rank (SJR) 2018: 1.191
Source Normalized Impact per Paper (SNIP) 2018: 1.205

Online
ISSN
1437-4331
See all formats and pricing
More options …
Volume 57, Issue 10

Issues

Continual improvement of the pre-analytical process in a public health laboratory with quality indicators-based risk management

Canan Karadağ / Nafi Nevrez Demirel
Published Online: 2019-05-03 | DOI: https://doi.org/10.1515/cclm-2019-0019

Abstract

Background

Quality indicators (QIs) and risk management are important tools for a quality management system designed to reduce errors in a laboratory. This study aimed to show the effectiveness of QI-based risk management for the continual improvement of pre-analytical processes in the Kayseri Public Health Laboratory (KPHL) which serves family physicians and collects samples from peripheral sampling units.

Methods

QIs of pre-analytical process were used for risk assessment with the failure modes and effects analysis (FMEA) method. Percentages and risk priority numbers (RPNs) of QIs were quantified. QI percentages were compared to the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) performance specifications and RPNs were compared to risk level scale, and corrective actions planned if needed. The effectiveness of risk treatment actions was re-evaluated with the new percentages and with RPNs of predefined QIs.

Results

RPNs related to four QIs required corrective action according to the risk evaluation scale. After risk treatment, the continual improvement was achieved for performance and risk level of “transcription errors”, for risk levels of “misidentified samples” and “not properly stored samples” and for the performance of “hemolyzed samples”. “Not properly stored samples” had the highest risk score because of sample storage and centrifugation problems of peripheral sampling units which are not under the responsibility of the KPHL.

Conclusions

Public health laboratories may have different risk priorities for pre-analytical process. Risk management based on predefined QIs can decrease the risk levels and increase QI performance as evidence-based examples for continual improvement of the pre-analytical process.

Keywords: continual improvement; FMEA; pre-analytical process; public health laboratory; quality indicators; risk management

References

  • 1.

    Plebani M. The detection and prevention of errors in laboratory medicine. Ann Clin Biochem 2010;47:101–10.Web of ScienceCrossrefPubMedGoogle Scholar

  • 2.

    Simundic AM, Lippi G. Preanalytical phase – a continuous challenge for laboratory professionals. Biochem Med (Zagreb) 2012;22:145–9.PubMedGoogle Scholar

  • 3.

    Plebani M, Sciacovelli L, Marinova M, Marcuccitti J, Chiozza ML. Quality indicators in laboratory medicine: a fundamental tool for quality and patient safety. Clin Biochem 2013;46:1170–4.PubMedWeb of ScienceCrossrefGoogle Scholar

  • 4.

    Barth JH. Clinical quality indicators in laboratory medicine. Ann Clin Biochem 2012;49:9–16.Web of ScienceCrossrefPubMedGoogle Scholar

  • 5.

    Lippi G, Guidi GC. Risk management in the preanalytical phase of laboratory testing. Clin Chem Lab Med 2007;45:720–7.PubMedWeb of ScienceGoogle Scholar

  • 6.

    Remona Eliza D, Monodora D. Risk management in laboratory medicine: from theory to practice. Acta Med Marisiensis 2015;61:372–77.CrossrefGoogle Scholar

  • 7.

    Plebani M. Quality in laboratory medicine: 50 years on. Clin Biochem 2017;50:101–4.Web of ScienceCrossrefGoogle Scholar

  • 8.

    ISO 15189:2012. Medical laboratories – requirements for quality and competence. Geneva, Switzerland: International Organization for Standardization, 2012.Google Scholar

  • 9.

    ISO Guide 73:2009. Risk management – Vocabulary. Geneva, Switzerland: International Organization for Standardization, 2009.Google Scholar

  • 10.

    ISO/IEC Guide 51:2014. Safety aspects – guidelines for their inclusion in standards. Geneva, Switzerland: International Organization for Standardization, 2014.Google Scholar

  • 11.

    ISO 31000:2018. Risk management – guidelines. Geneva, Switzerland: International Organization for Standardization, 2018.Google Scholar

  • 12.

    IEC 31010:2009. Risk management – risk assessment techniques. Geneva, Switzerland: International Organization for Standardization, 2009.Google Scholar

  • 13.

    ISO/TS 22367:2008. Medical laboratories – reduction of error through risk management and continual improvement. Geneva, Switzerland: International Organization for Standardization, 2008.Google Scholar

  • 14.

    CLSI document EP23-A. Laboratory quality control based on risk management; approved guideline. Wayne, PA: Clinical and Laboratory Standards Institute, 2012.Google Scholar

  • 15.

    CLSI document EP18-A2. Risk management techniques to identify and control laboratory error sources; approved guideline, 2nd ed. Wayne, PA: Clinical and Laboratory Standards Institute, 2009.Google Scholar

  • 16.

    Lu Y, Teng F, Zhou J, Wen A, Bi Y. Failure mode and effect analysis in blood transfusion: a proactive tool to reduce risks. Transfusion 2013;53:3080–7.PubMedWeb of ScienceCrossrefGoogle Scholar

  • 17.

    Romero A, Gómez-Salgado J, Romero-Arana A, Ruiz-Frutos C. Utilization of a health care failure mode and effects analysis to identify error. Biochem Med (Zagreb) 2018;28:020713.PubMedCrossrefGoogle Scholar

  • 18.

    Joint Commission on Accreditation of Healthcare Organizations. An introduction to FMEA. Using failure mode and effects analysis to meet JCAHO’s proactive risk assessment requirement. Failure Modes and Effect Analysis. Health Devices 2002;31:223–6.PubMedGoogle Scholar

  • 19.

    Ricos C, Biosca C, Ibarz M, Minchinela J, Llopis M, Perich C, et al. Quality indicators and specifications for strategic and support processes in laboratory medicine. Clin Chem Lab Med 2008;46:1189–94.Web of SciencePubMedGoogle Scholar

  • 20.

    Llopis MA, Trujillo G, Llovet MI, Tarrés E, Ibarz M, Biosca C, et al. Quality indicators and specifications for key, analytical-extra analytical process in the clinical laboratory. Five years’ experience using the six sigma concept. Clin Chem Lab Med 2011;49:463–70.PubMedGoogle Scholar

  • 21.

    Shcolnik W, de Oliveira CA, Sá de São José A, de Oliveira Galoro CA, Plebani M, Burnett D. Brazilian laboratory indicators program. Clin Chem Lab Med 2012;50:1923–34.PubMedWeb of ScienceGoogle Scholar

  • 22.

    Meier FA, Souers RJ, Howanitz PJ, Tworek JA, Perrotta PL, Nakhleh RE, et al. Seven Q-Tracks monitors of laboratory quality drive general performance improvement: experience from the College of American Pathologists Q-Tracks Program 1999–2011. Arch Pathol Lab Med 2015;139:762–75.CrossrefWeb of SciencePubMedGoogle Scholar

  • 23.

    Plebani M, Sciacovelli L, Lippi G. Quality indicators for laboratory diagnostics: consensus is needed. Ann Clin Biochem 2011;48:479.CrossrefWeb of SciencePubMedGoogle Scholar

  • 24.

    Sciacovelli L, Plebani M. The IFCC Working Group on laboratory errors and patient safety. Clin Chim Acta 2009;404:79–85.CrossrefWeb of ScienceGoogle Scholar

  • 25.

    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.Google Scholar

  • 26.

    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.PubMedWeb of ScienceGoogle Scholar

  • 27.

    Sciacovelli L, Lippi G, Sumarac Z, West J, Garcia Del Pino Castro I, Furtado Vieira K, et al. Working Group “Laboratory Errors and Patient Safety” of International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). Quality Indicators in Laboratory Medicine: the status of the progress of IFCC Working Group “Laboratory Errors and Patient Safety” project. Clin Chem Lab Med 2017;55:348–57.Google Scholar

  • 28.

    International Federation of Clinical Chemistry and Laboratory Medicine. Working Group “Laboratory Errors and Patient Safety, Model of Quality Indicators. Available at: http://www.ifcc-mqi.com/MqiWeb/resources/doc/Quality_Indicators_Key_Processes.pdf. Accessed: 5 Jan 2019.

  • 29.

    Plebani M, O’Kane M, Vermeersch P, Cadamuro J, Ooostherius H, Sciacovelli L, et al. The use of extra-analytical phase quality indicators by clinical laboratories: the results of an international survey. Clin Chem Lab Med 2016;54:e315–7.Web of SciencePubMedGoogle Scholar

  • 30.

    Flegar Mestric Z, Perkov S, Radeljak A, Paro MM. Risk analysis of the preanalytical process based on quality indicators data. Clin Chem Lab Med 2017;55:368–77.PubMedWeb of ScienceGoogle Scholar

  • 31.

    Badrick T, Gay S, Mackay M, Sikaris K. The key incident monitoring and management system – history and role in quality improvement. Clin Chem Lab Med 2018;56:264–72.PubMedCrossrefWeb of ScienceGoogle Scholar

  • 32.

    Zaninotto M, Tasinato A, Padoan A, Vecchiato G, Pinato A, Sciacovelli L, et al. Effects of sample transportation on commonly requested laboratory tests. Clin Chem Lab Med 2012;50:1755–60.PubMedWeb of ScienceGoogle Scholar

  • 33.

    Lippi G, Salvagno GL, Montagnana M, Guidi GC. Preparation of a quality sample: effect of centrifugation time on stat clinical chemistry testing. Lab Med 2007;38:172–6.CrossrefGoogle Scholar

  • 34.

    Lippi G, Salvagno GL, Danese E, Lima-Oliveira G, Brocco G, Guidi GC. Inversion of lithium heparin gel tubes after centrifugation is a significant source of bias in clinical chemistry testing. Clin Chim Acta 2014;436:183.Web of SciencePubMedCrossrefGoogle Scholar

  • 35.

    Lippi G, Banfi G, Churcha S, Cornesa M, De Carli G, Grankvist K, et al. Preanalytical quality improvement. In pursuit of harmony, on behalf of European Federation for Clinical Chemistry and Laboratory Medicine (EFLM Working group for Preanalytical Phase (WG-PRE). Clin Chem Lab Med 2015;53:357–70.Web of ScienceGoogle Scholar

  • 36.

    Giménez-Marín A, Rivas-Ruiz F, del Mar Pérez-Hidalgo M, Molina-Mendoza P. Pre-analytical errors management in the clinical laboratory: a five-year study. Biochem Med (Zagreb) 2014;24:248–57.CrossrefPubMedGoogle Scholar

  • 37.

    Bonini P, Plebani M, Ceriotti F, Rubboli F. Errors in laboratory medicine. Clin Chem 2002;48:691–8.PubMedGoogle Scholar

  • 38.

    Lippi G, Blanckaert N, Bonini P, Green S, Kitchen S, Palicka V, et al. Haemolysis: an overview of the leading cause of unsuitable specimens in clinical laboratories. Clin Chem Lab Med 2008;46:764–72.PubMedWeb of ScienceGoogle Scholar

  • 39.

    Romero A, Cobos A, Gómez J, Muñoz M. Role of training activities for the reduction of pre-analytical errors in laboratory samples from primary care. Clin Chim Acta 2012;413: 166–9.PubMedWeb of ScienceCrossrefGoogle Scholar

  • 40.

    Simundic AM, Cornes M, Grankvist K, Lippi G, Nybo M, Kovalevskaya S, et al. Survey of national guidelines, education and training on phlebotomy in 28 European countries: an original report by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for the Preanalytical Phase (WG-PA). Clin Chem Lab 2013;51:1585–93.Web of ScienceGoogle Scholar

  • 41.

    Lippi G, Sciacovelli L, Simundic AM, Plebani M. Innovative software for recording preanalytical errors in accord with the IFCC quality indicators. Clin Chem Lab Med 2017;55:e51–3.Web of SciencePubMedGoogle Scholar

  • 42.

    Aita A, Sciacovelli L, Plebani M. Extra-analytical quality indicators-where to now? Clin Chem Lab Med 2019;57:127–33.Web of ScienceGoogle Scholar

  • 43.

    Potts HW, Anderson JE, Colligan L, Leach P, Davis S, Berman J. Assessing the validity of prospective hazard analysis methods: a comparison of two techniques. BMC Health Serv Res 2014;14:41.Web of ScienceCrossrefPubMedGoogle Scholar

  • 44.

    Shebl NA, Franklin BD, Barber N. Failure mode and effects analysis outputs: are they valid? BMC Health Serv Res 2012;12:150.CrossrefPubMedWeb of ScienceGoogle Scholar

  • 45.

    Janssens PM. Practical, transparent prospective risk analysis for the clinical laboratory. Ann Clin Biochem 2014;51:695–704.CrossrefPubMedWeb of ScienceGoogle Scholar

  • 46.

    Plebani M. Quality in laboratory medicine: an unfinished journey. J Lab Precis Med 2017;2:63.CrossrefGoogle Scholar

  • 47.

    Lippi G, Plebani M. A Six-Sigma approach for comparing diagnostic errors in healthcare – where does laboratory medicine stand? Ann Transl Med 2018;6:180.CrossrefPubMedWeb of ScienceGoogle Scholar

  • 48.

    Aita A, Sciacovelli L, Plebani M. Laboratory-related errors: you cannot manage what you don’t measure. You manage what you know and measure. Diagnosis (Berl) 2017;4:193–5.PubMedCrossrefGoogle Scholar

About the article

Received: 2019-01-06

Accepted: 2019-04-08

Published Online: 2019-05-03

Published in Print: 2019-09-25


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

Research funding: 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.


Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 57, Issue 10, Pages 1530–1538, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2019-0019.

Export Citation

©2019 Walter de Gruyter GmbH, Berlin/Boston.Get Permission

Comments (0)

Please log in or register to comment.
Log in