Abstract
Background: The rate of auto-validation is dependent on the ability of the laboratory information system (LIS) to integrate historical data, on the frequency and methods for identifying analyzer errors, and on the criteria for reflex testing, including the need for peripheral smear review. The rate of auto-validation in outpatient laboratories, however, is unclear.
Methods: We examined 45,925 consecutive complete blood count (CBC) test results (1 January, 2014–31 January, 2014) from patients aged 50±24 years. The LIS auto-validates all samples according to set criteria. Technicians validated test results when previous CBC test results were required to determine: 1) the need for peripheral slide review and/or sample rerun or 2) the need for reflex testing to detect autoimmune hemolytic anemia or β-thalassemia minor.
Results: The auto-validation rates were 97.6% after rejecting results requiring validation to determine the need for a peripheral smear review and/or sample rerun. This decreased to 92.9% after including reflex testing to determine the reasons for normocytic and microcytic anemia. We estimated that auto-validation decreased the workload by 7.7–11.6 h per 3000 test results.
Conclusions: We conclude that very high auto-validation rates are possible in outpatient general laboratories, leading to conformity in the validation process and a considerable estimated savings in technician time. Further studies are needed in other settings.
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©2015 by De Gruyter
Articles in the same Issue
- Frontmatter
- Editorials
- The new and the old of heparin-induced thrombocytopenia
- Biological variation – reliable data is essential
- Biological variation: back to basics
- Review
- Influence of educational, audit and feedback, system based, and incentive and penalty interventions to reduce laboratory test utilization: a systematic review
- Opinion Papers
- Recent guidelines and recommendations for laboratory assessment of the direct oral anticoagulants (DOACs): is there consensus?
- Meeting report: present state of molecular genetics in clinical laboratories. Report on the VII European Symposium on Clinical Laboratory and In Vitro Diagnostic Industry in Barcelona
- Genetics and Molecular Diagnostics
- Non-invasive prenatal diagnosis of monogenic disorders: an optimized protocol using MEMO qPCR with miniSTR as internal control
- A novel biosensor-based microarray assay for the visualized detection of CYP2C19 ∗2, ∗3, ∗4 and ∗5 polymorphisms
- General Clinical Chemistry and Laboratory Medicine
- Preanalytical errors: a preliminary approach to the point of view of primary health care givers
- Comparison of Improvacuter™ tubes with BD Vacutainer™ tubes for various hormones in the aspects of stability and influence of gel separators
- Use of quality indicators to compare point-of-care testing errors in a neonatal unit and errors in a STAT central laboratory
- Serological features of antibodies to protamine inducing thrombocytopenia and thrombosis
- Comparison of three different immunoassays in the diagnosis of heparin-induced thrombocytopenia
- How the direct oral anticoagulant apixaban affects hemostatic parameters. Results of a multicenter multiplatform study
- Auto-validation of complete blood counts in an outpatient’s regional laboratory
- Performance evaluation of the digital cell imaging analyzer DI-60 integrated into the fully automated Sysmex XN hematology analyzer system
- Circulating keratan sulfate as a marker of metabolic changes of cartilage proteoglycan in juvenile idiopathic arthritis; influence of growth factors as well as proteolytic and prooxidative agents on aggrecan alterations
- Reference Values and Biological Variations
- Biological variation database: structure and criteria used for generation and update
- Cardiovascular Diseases
- The tumor necrosis factor-α –238G/A and IL-6 –572G/C gene polymorphisms and the risk of idiopathic dilated cardiomyopathy: a meta-analysis of 25 studies including 9493 cases and 13,971 controls
- Diabetes
- Multicentre evaluation of the Premier Hb9210 HbA1c analyser
- Infectious Diseases
- Determination of quality control limits for serological infectious disease testing using historical data
- Corrigendum
- Enrichment and enumeration of circulating tumor cells by efficient depletion of leukocyte fractions
- Letters to the Editors
- Influence of age and gender on red blood cell distribution width
- Effect of exhaustive running exercise on red blood cell distribution width
- Clinically useful samples and reference change value
- Loss of retinol stability in patient samples
- Evaluation of a new thyroglobulin sensitive assay in patients with differentiated thyroid cancer
- Caution in a case of highly discrepant carbohydrate antigen 19-9 values in an apparently healthy patient taking spirulina: a case report
- Influence of vitamin K antagonist treatment on activated partial thromboplastin time
- Evaluation of the diagnostic characteristics of urinary kidney injury molecule 1 (uKIM-1) and uKIM-1/creatinine ratio in the assessment of incipient diabetic kidney disease
Articles in the same Issue
- Frontmatter
- Editorials
- The new and the old of heparin-induced thrombocytopenia
- Biological variation – reliable data is essential
- Biological variation: back to basics
- Review
- Influence of educational, audit and feedback, system based, and incentive and penalty interventions to reduce laboratory test utilization: a systematic review
- Opinion Papers
- Recent guidelines and recommendations for laboratory assessment of the direct oral anticoagulants (DOACs): is there consensus?
- Meeting report: present state of molecular genetics in clinical laboratories. Report on the VII European Symposium on Clinical Laboratory and In Vitro Diagnostic Industry in Barcelona
- Genetics and Molecular Diagnostics
- Non-invasive prenatal diagnosis of monogenic disorders: an optimized protocol using MEMO qPCR with miniSTR as internal control
- A novel biosensor-based microarray assay for the visualized detection of CYP2C19 ∗2, ∗3, ∗4 and ∗5 polymorphisms
- General Clinical Chemistry and Laboratory Medicine
- Preanalytical errors: a preliminary approach to the point of view of primary health care givers
- Comparison of Improvacuter™ tubes with BD Vacutainer™ tubes for various hormones in the aspects of stability and influence of gel separators
- Use of quality indicators to compare point-of-care testing errors in a neonatal unit and errors in a STAT central laboratory
- Serological features of antibodies to protamine inducing thrombocytopenia and thrombosis
- Comparison of three different immunoassays in the diagnosis of heparin-induced thrombocytopenia
- How the direct oral anticoagulant apixaban affects hemostatic parameters. Results of a multicenter multiplatform study
- Auto-validation of complete blood counts in an outpatient’s regional laboratory
- Performance evaluation of the digital cell imaging analyzer DI-60 integrated into the fully automated Sysmex XN hematology analyzer system
- Circulating keratan sulfate as a marker of metabolic changes of cartilage proteoglycan in juvenile idiopathic arthritis; influence of growth factors as well as proteolytic and prooxidative agents on aggrecan alterations
- Reference Values and Biological Variations
- Biological variation database: structure and criteria used for generation and update
- Cardiovascular Diseases
- The tumor necrosis factor-α –238G/A and IL-6 –572G/C gene polymorphisms and the risk of idiopathic dilated cardiomyopathy: a meta-analysis of 25 studies including 9493 cases and 13,971 controls
- Diabetes
- Multicentre evaluation of the Premier Hb9210 HbA1c analyser
- Infectious Diseases
- Determination of quality control limits for serological infectious disease testing using historical data
- Corrigendum
- Enrichment and enumeration of circulating tumor cells by efficient depletion of leukocyte fractions
- Letters to the Editors
- Influence of age and gender on red blood cell distribution width
- Effect of exhaustive running exercise on red blood cell distribution width
- Clinically useful samples and reference change value
- Loss of retinol stability in patient samples
- Evaluation of a new thyroglobulin sensitive assay in patients with differentiated thyroid cancer
- Caution in a case of highly discrepant carbohydrate antigen 19-9 values in an apparently healthy patient taking spirulina: a case report
- Influence of vitamin K antagonist treatment on activated partial thromboplastin time
- Evaluation of the diagnostic characteristics of urinary kidney injury molecule 1 (uKIM-1) and uKIM-1/creatinine ratio in the assessment of incipient diabetic kidney disease