Abstract
The management of laboratory data in unsuitable (hemolyzed) samples remains an almost unresolved dilemma. Whether or not laboratory test results obtained by measuring unsuitable specimens should be made available to the clinicians has been the matter of fierce debates over the past decades. Recently, an intriguing alternative to suppressing test results and recollecting the specimen has been put forward, entailing the definition and implementation of specific algorithms that would finally allow reporting a preanalytically altered laboratory value within a specific comment about its uncertainty of measurement. This approach carries some advantages, namely the timely communication of potentially life-threatening laboratory values, but also some drawbacks. These especially include the challenging definition of validated performance specifications for hemolyzed samples, the need to producing reliable data with the lowest possible uncertainty, the short turnaround time for repeating most laboratory tests, the risk that the comments may be overlooked in short-stay and frequently overcrowded units (e.g. the emergency department), as well as the many clinical advantages of a direct communication with the physician in charge of the patient. Despite the debate remains open, we continue supporting the suggestion that suppressing data in unsuitable (hemolyzed) samples and promptly notifying the clinicians about the need to recollect the samples remains the most (clinically and analytically) safe practice.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None.
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.
References
1. Cadamuro J, Mrazek C, Haschke-Becher E, Sandberg S. To report or not to report: a proposal on how to deal with altered test results in haemolytic samples. Clin Chem Lab Med 2017;55:1109–11.10.1515/cclm-2016-1064Search in Google Scholar PubMed
2. Simundic AM, Topic E, Nikolac N, Lippi G. Hemolysis detection and management of hemolysed specimens. Biochem Med 2010;20:154–9.10.11613/BM.2010.018Search in Google Scholar
3. Lippi G, Mattiuzzi C. Critical laboratory values communication: summary recommendations from available guidelines. Ann Transl Med 2016;4:400.10.21037/atm.2016.09.36Search in Google Scholar PubMed PubMed Central
4. Lippi G, Avanzini P, Pavesi F, Bardi M, Ippolito L, Aloe R, et al. Studies on in vitro hemolysis and utility of corrective formulas for reporting results on hemolyzed specimens. Biochem Med (Zagreb) 2011;21:297–305.10.11613/BM.2011.040Search in Google Scholar PubMed
5. Lippi G, Salvagno GL, Guidi GC. Adjustment of serum potassium for age and platelet count. A simple step forward towards personalized medicine. Clin Chem Lab Med 2015;53:e325–7.10.1515/cclm-2015-0324Search in Google Scholar PubMed
6. Lippi G, Salvagno GL, Guidi GC. Mean corpuscular volume and red blood cell distribution width are independent predictors of serum potassium concentration in healthy individuals. Clin Chim Acta 2015;446:117–8.10.1016/j.cca.2015.04.017Search in Google Scholar PubMed
7. Brown PJ, Marquard JL, Amster B, Romoser M, Friderici J, Goff S, et al. What do physicians read (and ignore) in electronic progress notes? Appl Clin Inform 2014;5:430–44.10.4338/ACI-2014-01-RA-0003Search in Google Scholar PubMed PubMed Central
8. Keller H. Help with decisions on the assessment of clinical chemistry results. Z Med Lab Diagn 1989;30:416–24.Search in Google Scholar
9. Horowitz GL. The power of asterisks. Clin Chem 2015;61:1009–11.10.1373/clinchem.2015.243048Search in Google Scholar PubMed
10. Cervellin G, Lippi G. Repeated potassium testing in hemolyzed specimens collected in the emergency department: more pros than cons. J Emerg Med 2017;52:105–6.10.1016/j.jemermed.2016.07.119Search in Google Scholar PubMed
11. Panteghini M, Sandberg S. Defining analytical performance specifications 15 years after the Stockholm conference. Clin Chem Lab Med 2015;53:829–32.10.1515/cclm-2015-0303Search in Google Scholar PubMed
12. Plebani M. Harmonization in laboratory medicine: the complete picture. Clin Chem Lab Med 2013;51:741–51.10.1515/cclm-2013-0075Search in Google Scholar PubMed
13. Plebani M. Harmonization in laboratory medicine: requests, samples, measurements and reports. Crit Rev Clin Lab Sci 2016;53:184–96.10.3109/10408363.2015.1116851Search in Google Scholar PubMed
14. Lippi G, Banfi G, Buttarello M, Ceriotti F, Daves M, Dolci A, et al. Recommendations for detection and management of unsuitable samples in clinical laboratories. Clin Chem Lab Med 2007;45:728–36.10.1515/CCLM.2007.174Search in Google Scholar PubMed
15. Lippi G, Banfi G, Church S, Cornes 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;53:357–70.10.1515/cclm-2014-1051Search in Google Scholar PubMed
16. Lippi G, Bowen R, Adcock DM. Re-engineering laboratory diagnostics for preventing preanalytical errors. Clin Biochem 2016;49:1313–4.10.1016/j.clinbiochem.2016.10.010Search in Google Scholar PubMed
17. Lippi G, Plebani M, Di Somma S, Cervellin G. Hemolyzed specimens: a major challenge for emergency departments and clinical laboratories. Crit Rev Clin Lab Sci 2011;48:143–53.10.3109/10408363.2011.600228Search in Google Scholar PubMed
©2017 Walter de Gruyter GmbH, Berlin/Boston
Articles in the same Issue
- Frontmatter
- Editorial
- Biomarkers of acute kidney injury: a step forward
- Reviews
- Biomarkers of acute kidney injury: the pathway from discovery to clinical adoption
- Prognostic value of glycated hemoglobin among patients with ST-segment elevation myocardial infarction: a systematic review and meta-analysis
- Opinion Paper
- Traceability in laboratory medicine: a global driver for accurate results for patient care
- Point
- To report or not to report: a proposal on how to deal with altered test results in hemolytic samples
- Counterpoint
- Reporting altered test results in hemolyzed samples: is the cure worse than the disease?
- Genetics and Molecular Diagnostics
- Early mixed hematopoietic chimerism detection by digital droplet PCR in patients undergoing gender-mismatched hematopoietic stem cell transplantation
- Comparison of Abbott RealTime genotype II, GeneMatrix restriction fragment mass polymorphism and Sysmex HISCL HCV Gr assays for hepatitis C virus genotyping
- General Clinical Chemistry and Laboratory Medicine
- The relationship between vacuum and hemolysis during catheter blood collection: a retrospective analysis of six large cohorts
- Evaluation of the Greiner Bio-One serum separator BCA Fast Clot tube
- Implementation and application of moving average as continuous analytical quality control instrument demonstrated for 24 routine chemistry assays
- Parathormone stability in hemodialyzed patients and healthy subjects: comparison on non-centrifuged EDTA and serum samples with second- and third-generation assays
- Association between plasma proANP and hyperuricemia in Chinese Han women: a cross-sectional study
- Activity of the liver enzyme ornithine carbamoyltransferase (OTC) in blood: LC-MS/MS assay for non-invasive diagnosis of ornithine carbamoyltransferase deficiency
- Detecting paraprotein interference on a direct bilirubin assay by reviewing the photometric reaction data
- Prediction of human iron bioavailability using rapid c-ELISAs for human plasma hepcidin
- Reference Values and Biological Variations
- Determination of glucose-6-phosphate dehydrogenase cut-off values in a Tunisian population
- Plasma levels of endothelin-1 and renal function among young and healthy adults
- Cancer Diagnostics
- A new strategy for calculating the risk of ovarian malignancy algorithm (ROMA)
- Laboratory characterization of leukemic cell procoagulants
- Diabetes
- Preparation, calibration and evaluation of the First International Standard for human C-peptide
- Hb variants in Korea: effect on HbA1c using five routine methods
- Letters to the Editor
- Pseudohyperkalemia in capillary whole-blood samples – an occasional error or a significant problem in a pediatric hospital?
- Elevation of creatine kinase is linked to disease severity and predicts fatal outcomes in H7N9 infection
- Analytical evaluation of point-of-care procalcitonin (PCT) and clinical performances in an unselected population as compared with central lab PCT assay
- Evaluation of an automated commercial ELISA method for calprotectin determination in pleural fluid
- The unfinished story of interference in thyroid hormones with Roche immunoassays: when prewashing procedures matter
- Effects of apixaban on prothrombin time, activated partial thromboplastin time and anti-Xa assays: a European survey
- Evaluation of a chemiluminescent immunoassay for urinary aldosterone on the DiaSorin LIAISON automated platform against RIA and LC-MS/MS
- Complex considerations when tendering for HbA1c analysers
Articles in the same Issue
- Frontmatter
- Editorial
- Biomarkers of acute kidney injury: a step forward
- Reviews
- Biomarkers of acute kidney injury: the pathway from discovery to clinical adoption
- Prognostic value of glycated hemoglobin among patients with ST-segment elevation myocardial infarction: a systematic review and meta-analysis
- Opinion Paper
- Traceability in laboratory medicine: a global driver for accurate results for patient care
- Point
- To report or not to report: a proposal on how to deal with altered test results in hemolytic samples
- Counterpoint
- Reporting altered test results in hemolyzed samples: is the cure worse than the disease?
- Genetics and Molecular Diagnostics
- Early mixed hematopoietic chimerism detection by digital droplet PCR in patients undergoing gender-mismatched hematopoietic stem cell transplantation
- Comparison of Abbott RealTime genotype II, GeneMatrix restriction fragment mass polymorphism and Sysmex HISCL HCV Gr assays for hepatitis C virus genotyping
- General Clinical Chemistry and Laboratory Medicine
- The relationship between vacuum and hemolysis during catheter blood collection: a retrospective analysis of six large cohorts
- Evaluation of the Greiner Bio-One serum separator BCA Fast Clot tube
- Implementation and application of moving average as continuous analytical quality control instrument demonstrated for 24 routine chemistry assays
- Parathormone stability in hemodialyzed patients and healthy subjects: comparison on non-centrifuged EDTA and serum samples with second- and third-generation assays
- Association between plasma proANP and hyperuricemia in Chinese Han women: a cross-sectional study
- Activity of the liver enzyme ornithine carbamoyltransferase (OTC) in blood: LC-MS/MS assay for non-invasive diagnosis of ornithine carbamoyltransferase deficiency
- Detecting paraprotein interference on a direct bilirubin assay by reviewing the photometric reaction data
- Prediction of human iron bioavailability using rapid c-ELISAs for human plasma hepcidin
- Reference Values and Biological Variations
- Determination of glucose-6-phosphate dehydrogenase cut-off values in a Tunisian population
- Plasma levels of endothelin-1 and renal function among young and healthy adults
- Cancer Diagnostics
- A new strategy for calculating the risk of ovarian malignancy algorithm (ROMA)
- Laboratory characterization of leukemic cell procoagulants
- Diabetes
- Preparation, calibration and evaluation of the First International Standard for human C-peptide
- Hb variants in Korea: effect on HbA1c using five routine methods
- Letters to the Editor
- Pseudohyperkalemia in capillary whole-blood samples – an occasional error or a significant problem in a pediatric hospital?
- Elevation of creatine kinase is linked to disease severity and predicts fatal outcomes in H7N9 infection
- Analytical evaluation of point-of-care procalcitonin (PCT) and clinical performances in an unselected population as compared with central lab PCT assay
- Evaluation of an automated commercial ELISA method for calprotectin determination in pleural fluid
- The unfinished story of interference in thyroid hormones with Roche immunoassays: when prewashing procedures matter
- Effects of apixaban on prothrombin time, activated partial thromboplastin time and anti-Xa assays: a European survey
- Evaluation of a chemiluminescent immunoassay for urinary aldosterone on the DiaSorin LIAISON automated platform against RIA and LC-MS/MS
- Complex considerations when tendering for HbA1c analysers