Skip to content
Licensed Unlicensed Requires Authentication Published by De Gruyter October 21, 2021

External quality assessment of serum indices: Spanish SEQC-ML program

Rubén Gómez Rioja ORCID logo, Monserrat Ventura, María Antonia Llopis, Josep Miquel Bauça, Andrea Caballero Garralda, Mercedes Ibarz ORCID logo, Debora Martinez, Carolina Gómez, Paloma Salas Gómez-Pablos, Isabel García del Pino, Jose Delgado, Juan Jose Puente and Iciar Marzana

Abstract

Objectives

Serum indices included in clinical chemistry instruments are widely used by laboratories to assess the quality of samples. Instruments that report quantitative results allow an evaluation of their diagnostic performance in a similar way to other biochemical tests. The Spanish Society of Laboratory Medicine (SEQC-ML) launched a monthly External Quality program of serum indices in 2018 using three lyophilized materials of simultaneous annual distribution. We present the results of the first three years of the program.

Methods

The use of four different quality control materials with different concentrations in three alternate months allows an annual evaluation of the participant’s accuracy. Assigned values are established by consensus among homogeneous groups, considering necessary at least 10 participants for a comparison at instrument level. The average percentage difference results per instrument allow the assessment of bias among groups.

Results

The imprecision of the three indices ranges between 3 and 9%, with no major differences among instruments. Significant differences were observed in all indices among instruments with more than 10 participants (Roche Cobas, Abbott Architect, Abbott Alinity and Siemens Advia). The 90th percentile of the distribution of percentage differences was used as the analytical performance specification (APS). An improvement in performance was observed in the first three years of the program, probably due to the learning curve effect. In 2020, APS of 7.8, 12.2 and 9.7% were proposed for hemolytic, icteric and lipemic indices, respectively.

Conclusions

Serum indices have a great impact on the quality and the reliability of laboratory test results. Participation in proficiency testing programs for serum indices is helpful to encourage harmonization among providers and laboratories.


Corresponding author: Rubén Gómez Rioja, Laboratory Medicine, La Paz – Cantoblanco – Carlos III University Hospital, Madrid, Spain, E-mail:

Acknowledgments

The design and maintenance of the Quality Assurance Schemes of the Spanish Society of Laboratory Medicine (SEQC ML) is carried out by the Programs Committee, composed by: Ma Carmen Perich Alsina (President); Beatriz Boned Juliani; Sandra Bullich Marín; Marià Cortés Rius; Pilar Fernández Calle; Rubén Gómez Rioja; Ma Antonia Llopis Díaz; Cecília Martínez Bru; Francisco Ramón Bauzá; Ángel Salas García; Margarida Simon Palmada; Montserrat Ventura Alemany.

  1. Research funding: None declared.

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

  3. Competing interests: Authors state no conflict of interest.

  4. Informed consent: Not applicable.

  5. Ethical approval: Not applicable.

References

1. Glick, MR, Ryder, KW, Vroon, DH, Masters, BE, Sonntag, O. Practical uses of serum indexes to reduce errors from lipemia, icterus, and hemolysis. Clin Chem 1990;36:1008.Search in Google Scholar

2. Simundic, AM, Nikolac, N, Ivankovic, V, Ferenec-Ruzic, D, Magdic, B, Kvaternik, M, et al.. Comparison of visual vs. automated detection of lipemic, icteric and hemolyzed specimens: can we rely on a human eye? Clin Chem Lab Med 2009;47:1361–5. https://doi.org/10.1515/CCLM.2009.306.Search in Google Scholar PubMed

3. Simundic, AM, Baird, G, Cadamuro, J, Costelloe, SJ, Lippi, G. Managing hemolyzed samples in clinical laboratories. Crit Rev Clin Lab Sci 2020;57:1–21. https://doi.org/10.1080/10408363.2019.1664391.Search in Google Scholar PubMed

4. Cadamuro, J, Lippi, G, von Meyer, A, Ibarz, M, van Dongen Lases, E, Cornes, M, et al.. European survey on preanalytical sample handling – part 2: practices of European laboratories on monitoring and processing haemolytic, icteric and lipemic samples. On behalf of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). Biochem Med 2019;29:020075. https://doi.org/10.11613/BM.2019.020705.Search in Google Scholar PubMed PubMed Central

5. Llopis, MA, Bauça, JM, Barba, N, Álvarez, V, Ventura, M, Ibarz, M, et al.. Spanish preanalytical quality monitoring program (SEQC), an overview of 12 years’ experience. Clin Chem Lab Med 2017;55:530–8. https://doi.org/10.1515/cclm-2016-0382.Search in Google Scholar PubMed

6. Sciacovelli, L, Lippi, G, Sumarac, Z, Pino Castro, IG, Ivanov, A, Guire, VD. Preanalytical quality indicators in laboratory medicine: performance of laboratories participating in the IFCC Working Group “Laboratory Errors and Patient Safety” project. Clin Chim Acta 2019;497:35–40. https://doi.org/10.1016/j.cca.2019.07.007.Search in Google Scholar PubMed

7. Soderberg, J, Jonsson, PA, Wallin, O, Grankvist, K, Hultdin, H. Haemolysis index – an estimate of preanalytical quality in primary health care. Clin Chem Lab Med 2009;47:940–4. https://doi.org/10.1515/CCLM.2009.227.Search in Google Scholar PubMed

8. External quality assurance programme for the pre-analytical phase. Spanish Society of Laboratory Medicine (SEQC ML). Website Spanish Society of Laboratory Medicine (SEQC ML). https://www.contcal.org/qcweb/Documents/90%20Avaluacio%20anual/120%20Programas%202019/03_preanalitica_2019-v4.pdf [Accessed 10 Jun 2021].Search in Google Scholar

9. Gay, S, Badrick, T. Changes in error rates in the Australian key incident monitoring and management system program. Biochem Med 2020;30:020704. https://doi.org/10.11613/BM.2020.020704.Search in Google Scholar PubMed PubMed Central

10. Salinas, M, López-Garrigos, M, Lugo, M, Gutierrez, M, Flors, L, Leiva-Salinas, C. Diagnostic accuracy of icteric index to detect abnormal total bilirubin values. J Clin Pathol 2012;65:928–33. https://doi.org/10.1136/jclinpath-2012-200811.Search in Google Scholar PubMed

11. Lippi, G, Favaloro, E, Franchini, M. Haemolysis index for the screening of intravascular haemolysis: a novel diagnostic opportunity? Blood Transfus 2018;16:433–7. https://doi.org/10.2450/2018.0045-18.Search in Google Scholar PubMed PubMed Central

12. Lippi, G, Cadamuro, J, Von Meyer, A. Simundic AM on behalf of EFLM WG PRE. Local quality assurance of serum or plasma (HIL) indices. Clin Biochem 2018;54:112–8. https://doi.org/10.1016/j.clinbiochem.2018.02.018.Search in Google Scholar PubMed

13. Serum indices control material: Liquichek serum indices. Website BioRad, Hercules, California, USA. https://www.bio-rad.com/es-es/product/liquichek-serum-indices?ID=ODKBM515 [Accessed Jun 2021].Search in Google Scholar

14. Website UK NEQAS. Birmingham quality. Serum indices (HIL) programme. https://birminghamquality.org.uk/eqa-programmes/hil/ [Accessed Jun 2021].Search in Google Scholar

15. Website the Royal College of Pathologist of Australasia. Quality assurance programmes (RPCAQCA). https://rcpaqap.com.au/?s=serum+indices [Accessed Jun 2021].Search in Google Scholar

16. Bush, J, Shepherd, S, Punyalack, W, Andersen, T, Grahan, P. How comparable are serum indices measurements between laboratories? Clin Biochem Rev 2020;41(Suppl):S20.10.1016/j.pathol.2020.01.333Search in Google Scholar

17. Gabaj, N, Miler, M, Vrtaric, A, Hemar, M, Filipi, P, Kocijancic, M, et al.. Precision, accuracy, cross reactivity and comparability of serum indices measurement on Abbott Architect c8000, Beckman Coulter AU5800 and Roche Cobas 6000 c501 clinical chemistry analyzers. Clin Chem Lab Med 2018;56:776–88. https://doi.org/10.1515/cclm-2017-0889.Search in Google Scholar PubMed

18. Farrell, CJ, Carter, AC. Serum indices: managing assay interference. Ann Clin Biochem 2016;53:527–38. https://doi.org/10.1177/0004563216643557.Search in Google Scholar PubMed

19. Von Meyer, A, Cadamuro, J, Lippi, G, Simundic, AM. Call for more transparency on serum indices: on behalf of the Working Group for Preanalytical Phase (WG-PRE) of the European Federation of Laboratory Medicine (EFLM). Clin Chim Acta 2018;484:328–32. https://doi.org/10.1016/j.cca.2018.03.043.Search in Google Scholar PubMed

20. Pasqualetti, S, Szőke, D, Panteghini, M. Suitability of icteric index (II) as front-line test for the identification of blood samples with abnormal total bilirubin (TB) concentrations. Biochim Clin 2015;39:270–4.Search in Google Scholar

21. Arbiol-Roca, A, Navarro-Badal, MR, Allende-Monclus, B. Utility of the icteric index for the management of bilirubin test requesting. Clin Chem Lab Med 2019;57:e318. https://doi.org/10.1515/cclm-2019-0193.Search in Google Scholar PubMed

22. Mondejar, R, Mayor Reyes, M, Melguizo Madrid, E, Cañavate Solano, C, Pérez Ramos, S. Utility of icteric index in clinical laboratories: more than a preanalytical indicator. Biochem Med 2021;31:020703. https://doi.org/10.11613/BM.2021.020703.Search in Google Scholar PubMed PubMed Central

Received: 2021-07-11
Accepted: 2021-09-24
Published Online: 2021-10-21
Published in Print: 2022-01-26

© 2021 Walter de Gruyter GmbH, Berlin/Boston

Scroll Up Arrow