Home Risk analysis of the preanalytical process based on quality indicators data
Article
Licensed
Unlicensed Requires Authentication

Risk analysis of the preanalytical process based on quality indicators data

  • Zlata Flegar-Meštrić EMAIL logo , Sonja Perkov , Andrea Radeljak , Mirjana Marijana Kardum Paro , Ingrid Prkačin and Ana Devčić-Jeras
Published/Copyright: August 31, 2016
Become an author with De Gruyter Brill
Submit Manuscript Author Information
Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 55 Issue 3

Abstract

Background:

Improving quality and patient safety in the medical biochemistry laboratory accredited according to the International Standard Organization (ISO 15189:2012) requires the patient-centered evaluation of errors based on the implementation of quality indicators (QIs) across the total testing process. Our main goal was to achieve quality improvement of the preanalytical process in an emergency laboratory which had the highest error rate using risk management principles.

Methods:

Failure mode and effects analysis (FMEA) was applied to analyze predefined preanalytical QIs and score laboratory failures for the failure demerit value (FDV), probability of failure (PF) and probability of failure remedy (PFR). Based on obtained scores (on a 10-point scale) risk priority numbers (RPNs) were calculated.

Results:

A total of five failure modes were identified in the preanalytic process. The calculated risks were “sample hemolysis” (RPN, 168),“misidentified samples” (RPN, 108),“samples clotted” (RPN, 90),“sample volume error” (RPN, 72) and “samples transported at inappropriate temperature” (RPN, 24). The activation of corrective risk-reducing measures for failure modes with RPN≥30 resulted in quality improvement with the significant decrease in reevaluated RPNs.

Conclusions:

The implementation of a preanalytical quality monitoring system based on observation of evidence-based QIs and patient-centered evaluation of errors through risk analysis with regular tailored education as well as implementing process improvements can effectively reduce preanalytical errors in the emergency laboratory and improve patient safety.

Keywords: failure mode and effects analysis (FMEA); harmonization; preanalytical process; quality indicators; risk analysis

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

  2. Research funding: None declared.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

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

2. 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;46:1170–4.10.1016/j.clinbiochem.2012.11.028Search in Google Scholar PubMed

3. 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

4. Plebani M, Chiozza ML, Sciacovelli L. Towards harmonization of quality indicators in laboratory medicine. Clin Chem Lab Med 2013;51:187–95.10.1515/cclm-2012-0582Search in Google Scholar PubMed

5. 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

6. Plebani M, Sciacovelli L, Aita A, Chiozza ML. Harmonization of pre-analytical quality indicators. Biochem Med 2014;24:105–13.10.11613/BM.2014.012Search in Google Scholar PubMed PubMed Central

7. 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

8. Plebani M, Sciacovelli L, Aita A, Padoan A, Chiozza ML. Quality indicators to detect pre-analytical errors in laboratory testing. Clin Chim Acta 2014;15:44–8.10.1016/j.cca.2013.07.033Search in Google Scholar PubMed

9. Lippi G, Guidi GC. Risk management in the preanalytical phase of laboratory testing. Clin Chem Lab Med 2007;45:720–7.10.1515/CCLM.2007.167Search in Google Scholar PubMed

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

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

12. International Organization for Standardization. ISO/PDTS 22367:2008. Medical laboratories – reduction of error through risk management and continual improvement. Geneva: ISO;2008.Search in Google Scholar

13. Janssens PM. Practical, transparent prospective risk analysis for the clinical laboratory. Ann Clin BiochemBiochem 2014;51:695–704.10.1177/0004563214521160Search in Google Scholar PubMed

14. Flegar-Meštrić Z, Nazor A, Perkov S, Šurina B, Kardum Paro MM, Šiftar Z, et al. Accreditation of Medical Laboratories in Croatia-Experiences of the Institute of Clinical Chemistry, University Hospital Merkur, Zagreb. Coll Antropol 2010;34:181–6.Search in Google Scholar

15. Flegar-Meštrić Z, Perkov S, Vučić- Lovrenčić M, Škegro D. Accreditation of medical biochemistry laboratories in Croatia and its role in improving patient safety. Diabetologia Croat 2013;42:94–102.Search in Google Scholar

16. O’Kane M. The reporting, classification and grading of Quality failures in the medical laboratory. Clin Chim Acta 2009;404:28–31.10.1016/j.cca.2009.03.023Search in Google Scholar PubMed

17. Sciacovelli L, Sonntag O, Padoan A, Zambon CF, Carraro P, Plebani M, et al. Monitoring quality indicators in laboratory medicine does not automatically result in quality improvement. Clin Chem Lab Med 2011;50:463–9.10.1515/cclm.2011.809Search in Google Scholar

18. Wagar EA, Ron Phipps R, Del Guidice R, Middleton LP, Bingham J, Prejean C, et al. Inpatient preanalytic process improvements. Arch Pathol Lab Med 2013;137:1753–60.10.5858/arpa.2012-0458-OASearch in Google Scholar PubMed

19. Lippi G, Becan-McBride K, Behulova D, Bowen RA, Church S, Delanghe J, et al. Preanalytical quality improvement: in quality we trust. Clin Chem Lab Med 2013;51:229–41.10.1515/cclm-2012-0597Search in Google Scholar PubMed

20. 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;413:166–9.10.1016/j.cca.2011.09.017Search in Google Scholar PubMed

21. Leniček Krleza J, Dorotic A, Grzunov A, Maradin M. Capillary blood sampling: national recommendations on behalf of the Croatian Society of Medical Biochemistry and Laboratory Medicine. Biochem Med (Zagreb) 2015;25:335–58.10.11613/BM.2015.034Search in Google Scholar PubMed PubMed Central

22. Nikolac N, Supak-Smolcic V, Simundic AM, Celap I. Croatian Society of Medical Biochemistry and Laboratory Medicine: national recommendations for venous blood sampling. Biochem Med 2013;23:242–54.10.11613/BM.2013.031Search in Google Scholar PubMed PubMed Central

23. Clinical Laboratory Standards Institute. Procedures for collection of diagnostic blood specimens by venipuncture; approved guideline, 6th ed. CLSI document H3-A6. Wayne, PA: CLSI, 2007.Search in Google Scholar

24. World Health Organization. WHO guidelines on drawing blood: best practices in phlebotomy. Geneva, Switzerland: WHO, 2010.Search in Google Scholar

25. Clinical Laboratory Standards Institute. Accuracy in patient and sample identification; approved guideline. CLSI document GP33-A. Wayne, PA: CLSI, 2010.Search in Google Scholar

26. Dongen-Lases EC, Cornes MP, Grankvist K, Ibarz M, Kristensen GB, Lippi G, et al. Working Group for Preanalytical Phase (WG-PRE), European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). Patient identification and tube labelling – a call for harmonisation. Clin Chem Lab Med 2016;54:1141–45.10.1515/cclm-2015-1089Search in Google Scholar PubMed

27. Plebani M. The quality indicator paradox. Clin Chem Lab Med 2016; 54:1119–22.10.1515/cclm-2015-1080Search in Google Scholar PubMed

28. 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

29. Chiozza ML, Ponzetti C. FMEA: a model for reducing medical errors. Clin Chim Acta 2009;404:75–8.10.1016/j.cca.2009.03.015Search in Google Scholar PubMed

30. Jiang Y, Jiang H, Ding S, Liu Q. Application of failure mode and effects analysis in a clinical chemistry laboratory. Clin Chim Acta 2015;448:80–5.10.1016/j.cca.2015.06.016Search in Google Scholar PubMed

31. Plebani M. Laboratory-associated and diagnostic errors:a neglected link. Diagnosis 2014;1:89–94.10.1515/dx-2013-0030Search in Google Scholar PubMed

32. Plebani M, Lippi G. Improving diagnosis and reducing diagnostic errors: the next frontier of laboratory medicine. Clin Chem Lab Med 2016;54:1117–18.10.1515/cclm-2016-0217Search in Google Scholar PubMed

Received: 2016-3-21
Accepted: 2016-7-20
Published Online: 2016-8-31
Published in Print: 2017-3-1

©2017 Walter de Gruyter GmbH, Berlin/Boston

Articles in the same Issue

  1. Frontmatter
  2. Editorials
  3. Targeting errors in microbiology: the case of the Gram stain
  4. Time for a holistic approach and standardization education in laboratory medicine
  5. Reviews
  6. Serum uric acid levels and risk of prehypertension: a meta-analysis
  7. Lactic acidosis: an update
  8. Mini Review
  9. Progress and impact of enzyme measurement standardization
  10. Opinion Paper
  11. Critical comments to a recent EFLM recommendation for the review of reference intervals
  12. IFCC Paper
  13. Quality Indicators in Laboratory Medicine: the status of the progress of IFCC Working Group “Laboratory Errors and Patient Safety” project
  14. Genetics and Molecular Diagnostics
  15. Evaluation and comparison of three assays for molecular detection of spinal muscular atrophy
  16. General Clinical Chemistry and Laboratory Medicine
  17. Risk analysis of the preanalytical process based on quality indicators data
  18. Analytical and clinical validation of the new Abbot Architect 25(OH)D assay: fit for purpose?
  19. Looking beyond linear regression and Bland-Altman plots: a comparison of the clinical performance of 25-hydroxyvitamin D tests
  20. Next-generation osmotic gradient ektacytometry for the diagnosis of hereditary spherocytosis: interlaboratory method validation and experience
  21. Diagnosis of sphingolipidoses: a new simultaneous measurement of lysosphingolipids by LC-MS/MS
  22. Monitoring nicotine intake from e-cigarettes: measurement of parent drug and metabolites in oral fluid and plasma
  23. Development of a rapid and quantitative lateral flow assay for the simultaneous measurement of serum κ and λ immunoglobulin free light chains (FLC): inception of a new near-patient FLC screening tool
  24. A real-world evidence-based approach to laboratory reorganization using e-Valuate benchmarking data
  25. Cancer Diagnostics
  26. Utility of proGRP as a tumor marker in the medullary thyroid carcinoma
  27. Cardiovascular Diseases
  28. Can non-cholesterol sterols and lipoprotein subclasses distribution predict different patterns of cholesterol metabolism and statin therapy response?
  29. Infectious Diseases
  30. Improving Gram stain proficiency in hospital and satellite laboratories that do not have microbiology
  31. Diabetes
  32. Volumetric absorptive microsampling at home as an alternative tool for the monitoring of HbA1c in diabetes patients
  33. Corrigendum
  34. EFLM Recommendation
  35. Corrigendum to: Recommendation for the review of biological reference intervals in medical laboratories
  36. Letters to the Editor
  37. Evaluation of the trueness of serum alkaline phosphatase measurement in a group of Italian laboratories
  38. Innovative software for recording preanalytical errors in accord with the IFCC quality indicators
  39. Mixing studies for abnormal coagulation screen – the current trend
  40. Identification of 5-fluorocytosine as a new interfering compound in serum capillary zone electrophoresis
  41. How to define reference intervals to rule in healthy individuals for clinical trials?
  42. Evaluation of the performance of INDEXOR® in the archive unit of a clinical laboratory: a step to Lean laboratory
  43. Evaluation of an automated chemiluminescent immunoassay for salivary cortisol measurement. Utility in the diagnosis of Cushing’s syndrome
  44. Analysis of hemolysis, icterus and lipemia in arterial blood gas specimens
  45. Comparison of three routine insulin immunoassays: implications for assessment of insulin sensitivity and response
https://doi.org/10.1515/cclm-2016-0235
Keywords for this article
failure mode and effects analysis (FMEA); harmonization; preanalytical process; quality indicators; risk analysis

Articles in the same Issue

  1. Frontmatter
  2. Editorials
  3. Targeting errors in microbiology: the case of the Gram stain
  4. Time for a holistic approach and standardization education in laboratory medicine
  5. Reviews
  6. Serum uric acid levels and risk of prehypertension: a meta-analysis
  7. Lactic acidosis: an update
  8. Mini Review
  9. Progress and impact of enzyme measurement standardization
  10. Opinion Paper
  11. Critical comments to a recent EFLM recommendation for the review of reference intervals
  12. IFCC Paper
  13. Quality Indicators in Laboratory Medicine: the status of the progress of IFCC Working Group “Laboratory Errors and Patient Safety” project
  14. Genetics and Molecular Diagnostics
  15. Evaluation and comparison of three assays for molecular detection of spinal muscular atrophy
  16. General Clinical Chemistry and Laboratory Medicine
  17. Risk analysis of the preanalytical process based on quality indicators data
  18. Analytical and clinical validation of the new Abbot Architect 25(OH)D assay: fit for purpose?
  19. Looking beyond linear regression and Bland-Altman plots: a comparison of the clinical performance of 25-hydroxyvitamin D tests
  20. Next-generation osmotic gradient ektacytometry for the diagnosis of hereditary spherocytosis: interlaboratory method validation and experience
  21. Diagnosis of sphingolipidoses: a new simultaneous measurement of lysosphingolipids by LC-MS/MS
  22. Monitoring nicotine intake from e-cigarettes: measurement of parent drug and metabolites in oral fluid and plasma
  23. Development of a rapid and quantitative lateral flow assay for the simultaneous measurement of serum κ and λ immunoglobulin free light chains (FLC): inception of a new near-patient FLC screening tool
  24. A real-world evidence-based approach to laboratory reorganization using e-Valuate benchmarking data
  25. Cancer Diagnostics
  26. Utility of proGRP as a tumor marker in the medullary thyroid carcinoma
  27. Cardiovascular Diseases
  28. Can non-cholesterol sterols and lipoprotein subclasses distribution predict different patterns of cholesterol metabolism and statin therapy response?
  29. Infectious Diseases
  30. Improving Gram stain proficiency in hospital and satellite laboratories that do not have microbiology
  31. Diabetes
  32. Volumetric absorptive microsampling at home as an alternative tool for the monitoring of HbA1c in diabetes patients
  33. Corrigendum
  34. EFLM Recommendation
  35. Corrigendum to: Recommendation for the review of biological reference intervals in medical laboratories
  36. Letters to the Editor
  37. Evaluation of the trueness of serum alkaline phosphatase measurement in a group of Italian laboratories
  38. Innovative software for recording preanalytical errors in accord with the IFCC quality indicators
  39. Mixing studies for abnormal coagulation screen – the current trend
  40. Identification of 5-fluorocytosine as a new interfering compound in serum capillary zone electrophoresis
  41. How to define reference intervals to rule in healthy individuals for clinical trials?
  42. Evaluation of the performance of INDEXOR® in the archive unit of a clinical laboratory: a step to Lean laboratory
  43. Evaluation of an automated chemiluminescent immunoassay for salivary cortisol measurement. Utility in the diagnosis of Cushing’s syndrome
  44. Analysis of hemolysis, icterus and lipemia in arterial blood gas specimens
  45. Comparison of three routine insulin immunoassays: implications for assessment of insulin sensitivity and response
Sign up now to receive a 20% welcome discount
Institutional Access
How does access work?
Have an idea on how to improve our website?
Please write us.
© 2025 De Gruyter Brill
Downloaded on 9.9.2025 from https://www.degruyterbrill.com/document/doi/10.1515/cclm-2016-0235/html
Scroll to top button