Home Medicine Advancing value-based laboratory medicine
Article
Licensed
Unlicensed Requires Authentication

Advancing value-based laboratory medicine

  • Mario Plebani ORCID logo EMAIL logo
Published/Copyright: July 29, 2024
Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 63 Issue 2

Abstract

Following the COVID-19 pandemic, the concepts of value-based medicine (VBM) and value-based laboratory medicine (VBLM) are receiving increasing interest to improve the quality, sustainability and safety of healthcare. Laboratory medicine is well positioned to support the transition to value-based healthcare as it helps to improve clinical outcomes and healthcare sustainability by reducing the time to diagnosis, improving diagnostic accuracy, providing effective guidance for tailored therapies and monitoring, and supporting screening and wellness care. However, the perception of the value of laboratory medicine is still limited, to the extent that it has been defined a “profession without a face”, often lacking visibility to patients and the public. In addition, in recent decades, clinical laboratories have sought to improve the ration between outcomes and costs by increasing efficiency and reducing the cost per test rather than improving clinical outcomes. The aim of this paper is to propose a 10-point manifesto for implementing value-based laboratory medicine in clinical practice.

Keywords: value-based laboratory medicine; outcomes; costs; clinical laboratory; quality; sustainability
Corresponding author: Mario Plebani, Honorary Professor of Clinical Biochemistry and Clinical Molecular Biology, University of Padova, Via Giustiniani 2, 35128 Padova, Italy, E-mail:

  1. Research ethics: Not applicable.

  2. Informed consent: Not applicable.

  3. Author contributions: The author has accepted responsibility for the entire content of this manuscript and approved its submission.

  4. Competing interests: The author states no conflict of interest.

  5. Research funding: None declared.

  6. Data availability: Not applicable.

References

1. Plebani, M. Laboratory medicine in the COVID-19 era: six lessons for the future. Clin Chem Lab Med 2021;59:1035–45. https://doi.org/10.1515/cclm-2021-0367.Search in Google Scholar PubMed

2. Porter, ME. Value-based health care delivery. Ann Surg 2008;248:503–9. https://doi.org/10.1097/sla.0b013e31818a43af.Search in Google Scholar

3. Plebani, M. Quality and future of clinical laboratories: the Vico’s whole cyclical theory of the recurring cycles. Clin Chem Lab Med 2018;56:901–8. https://doi.org/10.1515/cclm-2018-0009.Search in Google Scholar PubMed

4. Porter, ME, Teisberg, EO. Redefining health care: creating value-based competition on results. Boston: Harvard Business School Press; 2006.Search in Google Scholar

5. Porter, ME, Teisberg, EO. How physicians can change the future of health care. JAMA 2007;297:1103–11. https://doi.org/10.1001/jama.297.10.1103.Search in Google Scholar PubMed

6. Porter, ME, Lee, TH. From volume to value in health care: the work begins. JAMA 2016;316:1047–8. https://doi.org/10.1001/jama.2016.11698.Search in Google Scholar PubMed

7. Shenfeld, DK, Navathe, AS, Emanuel, EJ. The promise and challenge of value-based payment. JAMA Intern Med 2024;184:716–17. https://doi.org/10.1001/jamainternmed.2024.1343.Search in Google Scholar PubMed

8. Plebani, M. The future of clinical laboratories: more testing or knowledge service. Clin Chem Lab Med 2005;43:893–6. https://doi.org/10.1515/cclm.2005.152.Search in Google Scholar

9. Plebani, M. Laboratory medicine: value for patients is the goal. Clin Chem 2007;53:1873–4. https://doi.org/10.1373/clinchem.2007.090563.Search in Google Scholar PubMed

10. Plebani, M. The detection and prevention of errors in laboratory medicine. Ann Clin Biochem 2010;47:101–10. https://doi.org/10.1258/acb.2009.009222.Search in Google Scholar PubMed

11. Plebani, M. Towards a new paradigm in laboratory medicine: the five rights. Clin Chem Lab Med 2016;54:1881–91. https://doi.org/10.1515/cclm-2016-0848.Search in Google Scholar PubMed

12. Plebani, M. Harmonizing the post-analytical phase: focus on the laboratory report. Clin Chem Lab Med 2024;62:1053–62. https://doi.org/10.1515/cclm-2023-1402.Search in Google Scholar PubMed

13. Plebani, M. Clinical laboratory: bigger is not always better. Diagnosis 2018;5:41–6. https://doi.org/10.1515/dx-2018-0019.Search in Google Scholar PubMed

14. Padoan, A, Plebani, M. Flowing through laboratory clinical data: the role of artificial intelligence and big data. Clin Chem Lab Med 2022;60:1875–80. https://doi.org/10.1515/cclm-2022-0653.Search in Google Scholar PubMed

15. Panteghini, M. An improved implementation of metrological traceability concepts is needed to benefit from standardization of laboratory results. Clin Chem Lab Med 2025;63:270–8. https://doi.org/10.1515/cclm-2024-0428.Search in Google Scholar PubMed

16. Zaninotto, M, Graziani, MS, Plebani, M. The harmonization issue in laboratory medicine: the commitment of CCLM. Clin Chem Lab Med 2022;61:721–31. https://doi.org/10.1515/cclm-2022-1111.Search in Google Scholar PubMed

17. ISO 21151:2020. In vitro diagnostic medical devices – requirements for international harmonisation protocols establishing metrological traceability of values. Geneva, Switzerland: International Organization for Standardization (ISO); 2021.Search in Google Scholar

18. ISO 17511:2020. In vitro diagnostic medical devices – requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples. Geneva, Switzerland: International Organization for Standardization (ISO); 2020.Search in Google Scholar

19. Plebani, M. Harmonization in laboratory medicine: more than clinical chemistry? Clin Chem Lab Med 2018;56:1579–86. https://doi.org/10.1515/cclm-2017-0865.Search in Google Scholar PubMed

20. Plebani, M Does POCT reduce the risk of error in laboratory testing? Clin Chim Acta 2009;404:59–64, https://doi.org/10.1016/j.cca.2009.03.014.Search in Google Scholar PubMed

21. Plebani, M, Nichols, JH, Luppa, PB, Greene, D, Sciacovelli, L, Shaw, J, et al.. Point-of-care testing: state-of-the art and perspectives. Clin Chem Lab Med 2024;63:35–51. https://doi.org/10.1515/cclm-2024-0675.Search in Google Scholar PubMed

22. Stavelin, A, Sandberg, S. Analytical performance specifications and quality assurance of point-of-care testing in primary healthcare. Crit Rev Clin Lab Sci 2024;61:164–77. https://doi.org/10.1080/10408363.2023.2262029.Search in Google Scholar PubMed

23. Pecoraro, V, Fasano, T, Aspromonte, N, Barocci, S, Bartolucci, D, Clerico, A, et al.. The role of laboratory medicine in a value-based healthcare system: the example of heart failure patient management in the Italian context. Eur Rev Med Pharmacol Sci 2023;27:10763–72. https://doi.org/10.26355/eurrev_202311_34356.Search in Google Scholar PubMed

24. Byrne, RA, Rossello, X, Coughlan, JJ, Barbato, E, Berry, C, Chieffo, A, ESC Scientific Document Group, et al.. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J 2023;44:3720–826. https://doi.org/10.1093/eurheartj/ehad191.Search in Google Scholar PubMed

25. Gaetani, L, Paolini Paoletti, F, Bellomo, G, Mancini, A, Simoni, S, Di Filippo, M, et al.. CSF and blood biomarkers in neuroinflammatory and neurodegenerative diseases: implications for treatment. Trends Pharmacol Sci 2020;41:1023–37. https://doi.org/10.1016/j.tips.2020.09.011.Search in Google Scholar PubMed

26. Austin, K, Deiss-Yehiely, N, Alexander, JT. Diagnosis and management of celiac disease. JAMA 2024. https://doi.org/10.1001/jama.2024.5883.Search in Google Scholar PubMed

27. Price, CP, John, AS, Christenson, R, Scharnhorst, V, Oellerich, M, Jones, P, et al.. Leveraging the real value of laboratory medicine with the value proposition. Clin Chim Acta 2016;462:183–6. https://doi.org/10.1016/j.cca.2016.09.006.Search in Google Scholar PubMed

28. Wilson, ML, Fleming, KA, Kuti, MA, Looi, LM, Lago, N, Ru, K. Access to pathology and laboratory medicine services: a crucial gap. Lancet 2018;391:1927–38. https://doi.org/10.1016/s0140-6736(18)30458-6.Search in Google Scholar

29. Beauchamp, NJ, Bryan, RN, Bui, MM, Krestin, GP, McGinty, GB, Meltzer, CC, et al.. Integrative diagnostics: the time is now-a report from the International Society for Strategic Studies in Radiology. Insights Imaging 2023;14:54. https://doi.org/10.1186/s13244-023-01379-9.Search in Google Scholar PubMed PubMed Central

30. Lippi, G, Plebani, M. Integrated diagnostics: the future of laboratory medicine? Biochem Med 2020;30:010501. https://doi.org/10.11613/BM.2020.010501.Search in Google Scholar PubMed PubMed Central

31. 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. https://doi.org/10.1016/j.clinbiochem.2012.11.028.Search in Google Scholar PubMed

32. Sciacovelli, L, Padoan, A, Aita, A, Basso, D, Plebani, M. Quality indicators in laboratory medicine: state-of-the-art, quality specifications and future strategies. Clin Chem Lab Med 2023;61:688–95. https://doi.org/10.1515/cclm-2022-1143.Search in Google Scholar PubMed

33. Horvath, AR, Lord, SJ, StJohn, A, Sandberg, S, Cobbaert, CM, Lorenz, S, et al.; For the test evaluation working group of the European Federation of Clinical Chemistry and Laboratory Medicine. From biomarkers to medical tests: the changing landscape of test evaluation. Clin Chim Acta 2014;427:49–57, https://doi.org/10.1016/j.cca.2013.09.018,Search in Google Scholar PubMed

34. Horvath, AR, Bell, KJL, Ceriotti, F, Jones, GRD, Loh, TP, Lord, S, et al.; Task group analytical performance specifications based on outcomes of the European Federation of Clinical Chemistry and Laboratory Medicine. Outcome-based analytical performance specifications: current status and future challenges. Clin Chem Lab Med 2024;62:1474–82. https://doi.org/10.1515/cclm-2024-0125.Search in Google Scholar PubMed

35. Werner, M. Linking analytic performance goals to medical outcome. Clin Chim Acta 1997;260:99–115. https://doi.org/10.1016/s0009-8981(96)06490-x.Search in Google Scholar PubMed

36. Lyon, AW, Kavsak, PA, Lyon, OA, Worster, A, Lyon, ME. Simulation models of misclassification error for single thresholds of high-sensitivity cardiac troponin I due to assay bias and imprecision. Clin Chem 2017;63:585–92. https://doi.org/10.1373/clinchem.2016.265058.Search in Google Scholar PubMed

37. Keutmann, S, Zylla, S, Dahl, M, Friedrich, N, Landgraf, R, Heinemann, L, et al.. Measurement uncertainty impacts diagnosis of diabetes mellitus: reliable minimal difference of plasma glucose results. Diabetes Ther 2020;11:293–303. https://doi.org/10.1007/s13300-019-00740-w.Search in Google Scholar PubMed PubMed Central

38. Pasqualetti, S, Aloisio, E, Panteghini, M. Letter to the Editor: serum albumin in COVID-19: a good example in which analytical and clinical performance of a laboratory test are strictly intertwined. Hepatology 2021;74:2905–7. https://doi.org/10.1002/hep.31791.Search in Google Scholar PubMed PubMed Central

39. Zhydkov, A, Christ-Crain, M, Thomann, R, Hoess, C, Henzen, C, Werner, Z, ProHOSP Study Group, et al.. Utility of procalcitonin, C-reactive protein and white blood cells alone and in combination for the prediction of clinical outcomes in community-acquired pneumonia. Clin Chem Lab Med 2015;53:559–66. https://doi.org/10.1515/cclm-2014-0456.Search in Google Scholar PubMed

40. Teisberg, EO, Wallace, S. Creating a high-value delivery system for health care. Semin Thorac Cardiovasc Surg 2009;21:35–42. https://doi.org/10.1053/j.semtcvs.2009.03.003.Search in Google Scholar PubMed

41. Trenti, T, Petrini, AM, Plebani, M. New reimbursement models to promote better patient outcomes and overall value in laboratory medicine and healthcare. Clin Chem Lab Med 2024;62:1795–803. https://doi.org/10.1515/cclm-2024-0168.Search in Google Scholar PubMed

42. Ducatman, BS, Ducatman, AM, Crawford, JM, Laposata, M, Sanfilippo, F. The value proposition for pathologists: a population health approach. Acad Pathol 2020;7:2374289519898857. https://doi.org/10.1177/2374289519898857.Search in Google Scholar PubMed PubMed Central

43. St John, A, O’Kane, M, Christenson, R, Jülicher, P, Oellerich, M, Price, CP. Implementation of medical tests in a Value-Based healthcare environment: a framework for delivering value. Clin Chim Acta 2021;521:90–6. https://doi.org/10.1016/j.cca.2021.07.004.Search in Google Scholar PubMed

44. St John, A, Price, CP, Hopstaken, R, McGinley, P, Melanson, S, O’Kane, M, et al.. Challenges associated with the effective implementation of new laboratory tests-the international experience. Clin Chem 2024;70:693–9. https://doi.org/10.1093/clinchem/hvae036.Search in Google Scholar PubMed

45. Moons, KG, Biesheuvel, CJ, Grobbee, DE. Test research versus diagnostic research. Clin Chem 2004;50:473–6. https://doi.org/10.1373/clinchem.2003.024752.Search in Google Scholar PubMed

46. Ferraro, S, Biganzoli, EM, Castaldi, S, Plebani, M. Health Technology Assessment to assess value of biomarkers in the decision-making process. Clin Chem Lab Med 2022;60:647–54. https://doi.org/10.1515/cclm-2021-1291.Search in Google Scholar PubMed

47. Plebani, M, Laposata, M, Lippi, G. A manifesto for the future of laboratory medicine professionals. Clin Chim Acta 2019;489:49–52. https://doi.org/10.1016/j.cca.2018.11.021.Search in Google Scholar PubMed

48. Dale, JC, Pruett, SK. Phlebotomy – a minimalist approach. Mayo Clin Proc 1993;68:249–55. https://doi.org/10.1016/s0025-6196(12)60044-5.Search in Google Scholar PubMed

49. Levi, M. Twenty-five million liters of blood into the sewer. J Thromb Hemost 2014;12:1592. https://doi.org/10.1111/jth.12656.Search in Google Scholar PubMed

50. Pennestrì, F, Tomaiuolo, R, Banfi, G, Dolci, A. Blood over-testing: impact, ethical issues and mitigating actions. Clin Chem Lab Med 2024;62:1283–7. https://doi.org/10.1515/cclm-2023-1227.Search in Google Scholar PubMed

51. Pennestrì, F, Banfi, G. Value-based healthcare: the role of laboratory medicine. Clin Chem Lab Med 2019;57:798–801. https://doi.org/10.1515/cclm-2018-1245.Search in Google Scholar PubMed

52. Tomaiuolo, R, Banfi, G. From volume to value: a watershed moment for the clinical laboratory. Clin Chem Lab Med 2023;62:593–6. https://doi.org/10.1515/cclm-2023-0870.Search in Google Scholar PubMed

53. Plebani, M. Value-based laboratory medicine: the time is now. Clin Chem Lab Med 2023;62:579–80. https://doi.org/10.1515/cclm-2023-1095.Search in Google Scholar PubMed

Received: 2024-07-18
Accepted: 2024-07-24
Published Online: 2024-07-29
Published in Print: 2025-01-29

© 2024 Walter de Gruyter GmbH, Berlin/Boston

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. CD34+ progenitor cells meet metrology
  4. Reviews
  5. Venous blood collection systems using evacuated tubes: a systematic review focusing on safety, efficacy and economic implications of integrated vs. combined systems
  6. The correlation between serum angiopoietin-2 levels and acute kidney injury (AKI): a meta-analysis
  7. Opinion Papers
  8. Advancing value-based laboratory medicine
  9. Clostebol and sport: about controversies involving contamination vs. doping offence
  10. Direct-to-consumer testing as consumer initiated testing: compromises to the testing process and opportunities for quality improvement
  11. Perspectives
  12. An improved implementation of metrological traceability concepts is needed to benefit from standardization of laboratory results
  13. Genetics and Molecular Diagnostics
  14. Comparative analysis of BCR::ABL1 p210 mRNA transcript quantification and ratio to ABL1 control gene converted to the International Scale by chip digital PCR and droplet digital PCR for monitoring patients with chronic myeloid leukemia
  15. General Clinical Chemistry and Laboratory Medicine
  16. IVDCheckR – simplifying documentation for laboratory developed tests according to IVDR requirements by introducing a new digital tool
  17. Analytical performance specifications for trace elements in biological fluids derived from six countries federated external quality assessment schemes over 10 years
  18. The effects of drone transportation on routine laboratory, immunohematology, flow cytometry and molecular analyses
  19. Accurate non-ceruloplasmin bound copper: a new biomarker for the assessment and monitoring of Wilson disease patients using HPLC coupled to ICP-MS/MS
  20. Construction of platelet count-optical method reflex test rules using Micro-RBC#, Macro-RBC%, “PLT clumps?” flag, and “PLT abnormal histogram” flag on the Mindray BC-6800plus hematology analyzer in clinical practice
  21. Evaluation of serum NFL, T-tau, p-tau181, p-tau217, Aβ40 and Aβ42 for the diagnosis of neurodegenerative diseases
  22. An immuno-DOT diagnostic assay for autoimmune nodopathy
  23. Evaluation of biochemical algorithms to screen dysbetalipoproteinemia in ε2ε2 and rare APOE variants carriers
  24. Reference Values and Biological Variations
  25. Allowable total error in CD34 cell analysis by flow cytometry based on state of the art using Spanish EQAS data
  26. Clinical utility of personalized reference intervals for CEA in the early detection of oncologic disease
  27. Agreement of lymphocyte subsets detection permits reference intervals transference between flow cytometry systems: direct validation using established reference intervals
  28. Cancer Diagnostics
  29. Atypical cells in urine sediment: a novel biomarker for early detection of bladder cancer
  30. External quality assessment-based tumor marker harmonization simulation; insights in achievable harmonization for CA 15-3 and CEA
  31. Cardiovascular Diseases
  32. Evaluation of the analytical and clinical performance of a high-sensitivity troponin I point-of-care assay in the Mersey Acute Coronary Syndrome Rule Out Study (MACROS-2)
  33. Analytical verification of the Atellica VTLi point of care high sensitivity troponin I assay
  34. Infectious Diseases
  35. Synovial fluid D-lactate – a pathogen-specific biomarker for septic arthritis: a prospective multicenter study
  36. Targeted MRM-analysis of plasma proteins in frozen whole blood samples from patients with COVID-19: a retrospective study
  37. Letters to the Editor
  38. Generative artificial intelligence (AI) for reporting the performance of laboratory biomarkers: not ready for prime time
  39. Urgent need to adopt age-specific TSH upper reference limit for the elderly – a position statement of the Belgian thyroid club
  40. Sigma metric is more correlated with analytical imprecision than bias
  41. Utility and limitations of monitoring kidney transplants using capillary sampling
  42. Simple flow cytometry method using a myeloma panel that easily reveals clonal proliferation of mature B-cells
  43. Is sweat conductivity still a relevant screening test for cystic fibrosis? Participation over 10 years
  44. Hb D-Iran interference on HbA1c measurement
https://doi.org/10.1515/cclm-2024-0823
Keywords for this article
value-based laboratory medicine; outcomes; costs; clinical laboratory; quality; sustainability

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. CD34+ progenitor cells meet metrology
  4. Reviews
  5. Venous blood collection systems using evacuated tubes: a systematic review focusing on safety, efficacy and economic implications of integrated vs. combined systems
  6. The correlation between serum angiopoietin-2 levels and acute kidney injury (AKI): a meta-analysis
  7. Opinion Papers
  8. Advancing value-based laboratory medicine
  9. Clostebol and sport: about controversies involving contamination vs. doping offence
  10. Direct-to-consumer testing as consumer initiated testing: compromises to the testing process and opportunities for quality improvement
  11. Perspectives
  12. An improved implementation of metrological traceability concepts is needed to benefit from standardization of laboratory results
  13. Genetics and Molecular Diagnostics
  14. Comparative analysis of BCR::ABL1 p210 mRNA transcript quantification and ratio to ABL1 control gene converted to the International Scale by chip digital PCR and droplet digital PCR for monitoring patients with chronic myeloid leukemia
  15. General Clinical Chemistry and Laboratory Medicine
  16. IVDCheckR – simplifying documentation for laboratory developed tests according to IVDR requirements by introducing a new digital tool
  17. Analytical performance specifications for trace elements in biological fluids derived from six countries federated external quality assessment schemes over 10 years
  18. The effects of drone transportation on routine laboratory, immunohematology, flow cytometry and molecular analyses
  19. Accurate non-ceruloplasmin bound copper: a new biomarker for the assessment and monitoring of Wilson disease patients using HPLC coupled to ICP-MS/MS
  20. Construction of platelet count-optical method reflex test rules using Micro-RBC#, Macro-RBC%, “PLT clumps?” flag, and “PLT abnormal histogram” flag on the Mindray BC-6800plus hematology analyzer in clinical practice
  21. Evaluation of serum NFL, T-tau, p-tau181, p-tau217, Aβ40 and Aβ42 for the diagnosis of neurodegenerative diseases
  22. An immuno-DOT diagnostic assay for autoimmune nodopathy
  23. Evaluation of biochemical algorithms to screen dysbetalipoproteinemia in ε2ε2 and rare APOE variants carriers
  24. Reference Values and Biological Variations
  25. Allowable total error in CD34 cell analysis by flow cytometry based on state of the art using Spanish EQAS data
  26. Clinical utility of personalized reference intervals for CEA in the early detection of oncologic disease
  27. Agreement of lymphocyte subsets detection permits reference intervals transference between flow cytometry systems: direct validation using established reference intervals
  28. Cancer Diagnostics
  29. Atypical cells in urine sediment: a novel biomarker for early detection of bladder cancer
  30. External quality assessment-based tumor marker harmonization simulation; insights in achievable harmonization for CA 15-3 and CEA
  31. Cardiovascular Diseases
  32. Evaluation of the analytical and clinical performance of a high-sensitivity troponin I point-of-care assay in the Mersey Acute Coronary Syndrome Rule Out Study (MACROS-2)
  33. Analytical verification of the Atellica VTLi point of care high sensitivity troponin I assay
  34. Infectious Diseases
  35. Synovial fluid D-lactate – a pathogen-specific biomarker for septic arthritis: a prospective multicenter study
  36. Targeted MRM-analysis of plasma proteins in frozen whole blood samples from patients with COVID-19: a retrospective study
  37. Letters to the Editor
  38. Generative artificial intelligence (AI) for reporting the performance of laboratory biomarkers: not ready for prime time
  39. Urgent need to adopt age-specific TSH upper reference limit for the elderly – a position statement of the Belgian thyroid club
  40. Sigma metric is more correlated with analytical imprecision than bias
  41. Utility and limitations of monitoring kidney transplants using capillary sampling
  42. Simple flow cytometry method using a myeloma panel that easily reveals clonal proliferation of mature B-cells
  43. Is sweat conductivity still a relevant screening test for cystic fibrosis? Participation over 10 years
  44. Hb D-Iran interference on HbA1c measurement
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.
© 2026 De Gruyter Brill
Downloaded on 16.1.2026 from https://www.degruyterbrill.com/document/doi/10.1515/cclm-2024-0823/html
Scroll to top button