Current status of verification practices in clinical biochemistry in Spain
-
Rubén Gómez-Rioja
,
Virtudes Álvarez
Abstract
Background: Verification uses logical algorithms to detect potential errors before laboratory results are released to the clinician. Even though verification is one of the main processes in all laboratories, there is a lack of standardization mainly in the algorithms used and the criteria and verification limits applied. A survey in clinical laboratories in Spain was conducted in order to assess the verification process, particularly the use of autoverification.
Methods: Questionnaires were sent to the laboratories involved in the External Quality Assurance Program organized by the Spanish Society of Clinical Biochemistry and Molecular Pathology. Seven common biochemical parameters were included (glucose, cholesterol, triglycerides, creatinine, potassium, calcium, and alanine aminotransferase).
Results: Completed questionnaires were received from 85 laboratories. Nearly all the laboratories reported using the following seven verification criteria: internal quality control, instrument warnings, sample deterioration, reference limits, clinical data, concordance between parameters, and verification of results. The use of all verification criteria varied according to the type of verification (automatic, technical, or medical). Verification limits for these parameters are similar to biological reference ranges. Delta Check was used in 24% of laboratories. Most laboratories (64%) reported using autoverification systems. Autoverification use was related to laboratory size, ownership, and type of laboratory information system, but amount of use (percentage of test autoverified) was not related to laboratory size.
Conclusions: A total of 36% of Spanish laboratories do not use autoverification, despite the general implementation of laboratory information systems, most of them, with autoverification ability. Criteria and rules for seven routine biochemical tests were obtained.
References
1. Plebani M, Lippi G. Improving the post-analytical phase. Clin Chem Lab Med 2010;48:435–6.10.1515/CCLM.2010.113Search in Google Scholar
2. Prinsloo PJ, Gray TA. A survey of laboratory practice in the clinical authorization and reporting of results. Ann Clin Biochem 2003;40:149–55.10.1258/000456303763046076Search in Google Scholar
3. Miller J. Postanalytical data review. In: Ward-Cook K, Lehmann G, Schoeff L, Williams R, editors. Clinical diagnostic technology. The whole testing process, vol. 3: the postanalytical phase. Washington: AACC Press, 2006;37–54.Search in Google Scholar
4. Autoverification of clinical laboratory test results; approved guideline. CLSI document AUTO10-A (ISBN 1-56238-620-4). Wayne, PA: Clinical and Laboratory Standards Institute, 2006.Search in Google Scholar
5. ISO 15189:2007. Medical laboratories – particular requirements for quality and competence. Geneva: ISO, 2007.Search in Google Scholar
6. Torke N, Boral L, Nguyen T, Perri A, Chakrin A. Process improvement and operational efficiency autoverification through test result. Clin Chem 2005;51:2406–8.10.1373/clinchem.2005.054395Search in Google Scholar
7. De Smet D, Nanos N, Martens GA, Smet L, Damiaens S, Van Moer G, et al. Automated validation of clinical laboratory test results: do we get what we expect? Clin Chem Lab Med 2009;47:379–80.10.1515/CCLM.2009.079Search in Google Scholar
8. Guidi GC, Poli G, Bassi A, Giobelli L, Benetollo PP, Lippi G. Development and implementation of an automatic system for verification, validation and delivery of laboratory test results. Clin Chem Lab Med 2009;47:1355–60.10.1515/CCLM.2009.316Search in Google Scholar
9. Oosterhuis WP, Ulenkate HJ, Goldschmidt MH. Evaluation of Lab Respond, a new automated validation system for clinical laboratory test results. Clin Chem 2000; 46:1811–7.10.1093/clinchem/46.11.1811Search in Google Scholar
10. Pearlman ES, Bilello L, Stauffer J, Kamarinos A, Miele R, Wolfert MS. Implications of autoverification for the clinical laboratory. Clin Leadersh Manag Rev 2002;16:237–9.Search in Google Scholar
11. Crolla LJ, Westgard JO. Evaluation of rule-based autoverification protocols. Clin Leadersh Manag Rev 2003;17:268–72.Search in Google Scholar
12. Deetz C, Nolan D, Scott M. An examination of the usefulness of repeat testing practices in a large hospital clinical chemistry laboratory. J Clin Pathol 2012;137:20–5.10.1309/AJCPWPBF62YGEFORSearch in Google Scholar
13. Risk management techniques to identify and control laboratory error sources; approved guideline – 2nd ed. CLSI document EP18-A2 (ISBN 1-56238-712-X). Wayne, PA: Clinical and Laboratory Standards Institute, 2009.Search in Google Scholar
14. Barron J, Ng C, Aspin L, Robinson LJ, Smith G. Reflex testing to define action limits for community-based requests. Ann Clin Biochem 2012;49:337–40.10.1258/acb.2012.011103Search in Google Scholar
15. Wu AH, Ghani F, Prigent F, Petry C, Armstrong G, Graff L. Reflex testing II: evaluation of an algorithm for use of cardiac markers in the assessment of emergency department patients with chest pain. Clin Chim Acta 1999;288:97–109.10.1016/S0009-8981(99)00142-4Search in Google Scholar
©2013 by Walter de Gruyter Berlin Boston
Articles in the same Issue
- Masthead
- Masthead
- Editorials
- What is a biomarker? It’s time for a renewed definition
- Biomarker research and leading causes of death worldwide: a rather feeble relationship
- Thiosulfate in urine: new hope or new failure of a biomarker for prostate cancer?
- Review
- Acute coronary syndrome – the present and future role of biomarkers1)
- Mini Review
- Advance in molecular diagnostic tools for hepatitis B virus detection
- Opinion Paper
- Standardization and analytical goals for glycated hemoglobin measurement
- Guidelines and Recommendations
- Proposal for the use in emergency departments of cardiac troponins measured with the latest generation methods in patients with suspected acute coronary syndrome without persistent ST-segment elevation
- General Clinical Chemistry and Laboratory Medicine
- Current status of verification practices in clinical biochemistry in Spain
- Two site evaluation of the performance of a new generation point-of-care glucose meter for use in a neonatal intensive care unit
- Trp64Arg (rs4994) polymorphism of β3-adrenergic receptor gene is associated with hyperuricemia in a Chinese male population
- Quantification of vancomycin in human serum by LC-MS/MS
- Automated indirect immunofluorescence antinuclear antibody analysis is a standardized alternative for visual microscope interpretation
- Autocorrelation and cross-correlation between hCGβ and PAPP-A in repeated sampling during first trimester of pregnancy
- Platelet oxidative stress and systemic inflammation in chronic spontaneous urticaria
- Reference Values
- Establishment of reference values for novel urinary biomarkers for renal damage in the healthy population: are age and gender an issue?
- Risks of mortality associated with common laboratory tests: a novel, simple and meaningful way to set decision limits from data available in the Electronic Medical Record
- Cancer Diagnostics
- Cancer antigen 125, human epididymis 4, kallikrein 6, osteopontin and soluble mesothelin-related peptide immunocomplexed with immunoglobulin M in epithelial ovarian cancer diagnosis
- Thiosulfate in urine as a facilitator in the diagnosis of prostate cancer for patients with prostate-specific antigen less or equal 10 ng/mL
- Anemia and iron biomarkers in patients with early breast cancer. Diagnostic value of hepcidin and soluble transferrin receptor quantification1)
- Sensitive detection of EML4-ALK fusion oncoprotein of lung cancer by in situ proximity ligation assay
- Re-evaluation of laboratory predictors of response to current anemia treatment regimens of erythropoiesis stimulating agents in cancer patients
- Cardiovascular Diseases
- Evaluation of four sensitive troponin assays for risk assessment in acute coronary syndromes using a new clinically oriented approach for comparison of assays
- A combined index of cardiac biomarkers as a risk factor for early cardiovascular mortality in hemodialysis patients
- Prognostic utility of biochemical markers of cardiovascular risk: impact of biological variability
- Letters to the Editors
- Exploring the relationship between serum biomarkers, acute intracerebral changes and outcome after severe traumatic brain injury (TBI)
- Laboratory false-positive results: a clinician responsibility or a shared responsibility with requesting clinicians?
- The one hour lactose tolerance test
- High concentration of IgM-κ paraprotein causes over-estimation of serum total protein by certain biuret method
- Determining calculated free testosterone reference intervals in a normal adult male population
- Alveolar neopterin, procalcitonin, and IL-6 in relation to serum levels and severity of lung injury in ARDS
- Falsely elevated cobalamin concentration in multiple assays in a patient with pernicious anemia: a case study
- Leading Figures in Laboratory Medicine
- Research forever – Klaus Jung
Articles in the same Issue
- Masthead
- Masthead
- Editorials
- What is a biomarker? It’s time for a renewed definition
- Biomarker research and leading causes of death worldwide: a rather feeble relationship
- Thiosulfate in urine: new hope or new failure of a biomarker for prostate cancer?
- Review
- Acute coronary syndrome – the present and future role of biomarkers1)
- Mini Review
- Advance in molecular diagnostic tools for hepatitis B virus detection
- Opinion Paper
- Standardization and analytical goals for glycated hemoglobin measurement
- Guidelines and Recommendations
- Proposal for the use in emergency departments of cardiac troponins measured with the latest generation methods in patients with suspected acute coronary syndrome without persistent ST-segment elevation
- General Clinical Chemistry and Laboratory Medicine
- Current status of verification practices in clinical biochemistry in Spain
- Two site evaluation of the performance of a new generation point-of-care glucose meter for use in a neonatal intensive care unit
- Trp64Arg (rs4994) polymorphism of β3-adrenergic receptor gene is associated with hyperuricemia in a Chinese male population
- Quantification of vancomycin in human serum by LC-MS/MS
- Automated indirect immunofluorescence antinuclear antibody analysis is a standardized alternative for visual microscope interpretation
- Autocorrelation and cross-correlation between hCGβ and PAPP-A in repeated sampling during first trimester of pregnancy
- Platelet oxidative stress and systemic inflammation in chronic spontaneous urticaria
- Reference Values
- Establishment of reference values for novel urinary biomarkers for renal damage in the healthy population: are age and gender an issue?
- Risks of mortality associated with common laboratory tests: a novel, simple and meaningful way to set decision limits from data available in the Electronic Medical Record
- Cancer Diagnostics
- Cancer antigen 125, human epididymis 4, kallikrein 6, osteopontin and soluble mesothelin-related peptide immunocomplexed with immunoglobulin M in epithelial ovarian cancer diagnosis
- Thiosulfate in urine as a facilitator in the diagnosis of prostate cancer for patients with prostate-specific antigen less or equal 10 ng/mL
- Anemia and iron biomarkers in patients with early breast cancer. Diagnostic value of hepcidin and soluble transferrin receptor quantification1)
- Sensitive detection of EML4-ALK fusion oncoprotein of lung cancer by in situ proximity ligation assay
- Re-evaluation of laboratory predictors of response to current anemia treatment regimens of erythropoiesis stimulating agents in cancer patients
- Cardiovascular Diseases
- Evaluation of four sensitive troponin assays for risk assessment in acute coronary syndromes using a new clinically oriented approach for comparison of assays
- A combined index of cardiac biomarkers as a risk factor for early cardiovascular mortality in hemodialysis patients
- Prognostic utility of biochemical markers of cardiovascular risk: impact of biological variability
- Letters to the Editors
- Exploring the relationship between serum biomarkers, acute intracerebral changes and outcome after severe traumatic brain injury (TBI)
- Laboratory false-positive results: a clinician responsibility or a shared responsibility with requesting clinicians?
- The one hour lactose tolerance test
- High concentration of IgM-κ paraprotein causes over-estimation of serum total protein by certain biuret method
- Determining calculated free testosterone reference intervals in a normal adult male population
- Alveolar neopterin, procalcitonin, and IL-6 in relation to serum levels and severity of lung injury in ARDS
- Falsely elevated cobalamin concentration in multiple assays in a patient with pernicious anemia: a case study
- Leading Figures in Laboratory Medicine
- Research forever – Klaus Jung
