Autovalidation and automation of the postanalytical phase of routine hematology and coagulation analyses in a university hospital laboratory
-
Ana Mlinaric
,
Marija Milos
Abstract
Background:
The need to satisfy high-throughput demands for laboratory tests continues to be a challenge. Therefore, we aimed to automate postanalytical phase in hematology and coagulation laboratory by autovalidation of complete blood count (CBC) and routine coagulation test results (prothrombin time [PT], international normalized ratio [PT-INR], activated partial thromboplastin time [APTT], fibrinogen, antithrombin activity [AT] and thrombin time [TT]). Work efficacy and turnaround time (TAT) before and after implementation of automated solutions will be compared.
Methods:
Ordering panels tailored to specific patient populations were implemented. Rerun and reflex testing rules were set in the respective analyzers’ software (Coulter DxH Connectivity 1601, Beckman Coulter, FL, USA; AutoAssistant, Siemens Healthcare Diagnostics, Germany), and sample status information was transferred into the laboratory information system. To evaluate if the automation improved TAT and efficacy, data from manually verified results in September and October of 2015 were compared with the corresponding period in 2016 when autovalidation was implemented.
Results:
Autovalidation rates of 63% for CBC and 65% for routine coagulation test results were achieved. At the TAT of 120 min, the percentage of reported results increased substantially for all analyzed tests, being above 90% for CBC, PT, PT-INR and fibrinogen and 89% for APTT. This output was achieved with three laboratory technicians less compared with the period when the postanalytical phase was not automated.
Conclusions:
Automation allowed optimized laboratory workflow for specific patient populations, thereby ensuring standardized results reporting. Autovalidation of test results proved to be an efficient tool for improvement of laboratory work efficacy and TAT.
Acknowledgments
The authors wish to thank Mr. Kresimir Kules for his valuable contribution to the autovalidation data extraction.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
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. Shih MC, Chang HM, Tien N, Hsiao CT, Peng CT. Building and validating an autovalidation system in the clinical chemistry laboratory. Lab Med 2011;42:668–73.10.1309/LM5AM4IIXC4OIETDSearch in Google Scholar
2. Oosterhuis WP, Ulenkate HJ, Goldschmidt HM. 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
3. Duca DJ. Autovalidation in a laboratory information system. Lab Med 2012;1:21–5.Search in Google Scholar
4. 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 PubMed
5. Martinez-Nieto O, Lozano-Gaitán A, Beltrán-Diaz P, Mojica-Figueroa IL, Morales-Reyes OL, Isaza-Ruget MA. Autovalidation of the automated blood cell counter (CBC) in a reference laboratory in Bogota, Colombia. J Bras Patol Med Lab 2015;51:369–75.10.5935/1676-2444.20150058Search in Google Scholar
6. Croatian Chamber of Medical Biochemists. Recommendation for critical results reporting. Available at: http://www.hkmb.hr/dokumenti/povjerenstva/HKMB%20PPSP%208.pdf. Accessed: 30 May 2017.Search in Google Scholar
7. Barnes PW, McFadden SL, Machin SJ, Simson E. The international consensus group for hematology review. Suggested criteria for action following automated CBC and WBC differential analysis. Lab Hematol 2005;11:83–90.10.1532/LH96.05019Search in Google Scholar PubMed
8. Fraser CG. Reference change values. Clin Chem Lab Med 2011;50:807–12.10.1515/cclm.2011.733Search in Google Scholar PubMed
9. Ricos C, Alvarez V, Cava F, Garcia-Lario JV, Hernandez A, Jimenez CV, et al. Current databases on biologic variation: pros, cons and progress. Scand J Clin Lab Invest 1999;59: 491–500.10.1080/00365519950185229Search in Google Scholar PubMed
10. Buttarello M. Quality specification in hematology: the automated blood cell count. Clin Chim Acta 2004;346: 45–54.10.1016/j.cccn.2004.02.038Search in Google Scholar PubMed
11. Froom P, Barak M. Auto-validation of complete blood counts in an outpatient’s regional laboratory. Clin Chem Lab Med 2015;53:275–9.10.1515/cclm-2014-0572Search in Google Scholar PubMed
12. Froom P, Saffuri-Elias E, Barak M. Autovalidation rates in an outpatient coagulation laboratory. Int J Lab Hem 2015;37:380–5.10.1111/ijlh.12386Search in Google Scholar PubMed
13. Onelöv L, Gustafsson E, Grönlund E, Andersson H, Hellberg G, Järnberg I, et al. Autoverification of routine coagulation assays in a multi-center laboratory. Scand J Clin Lab 2016;76:500–2.10.1080/00365513.2016.1200135Search in Google Scholar PubMed
©2018 Walter de Gruyter GmbH, Berlin/Boston
Articles in the same Issue
- Frontmatter
- Editorial
- Analytical quality: an unfinished journey
- Reviews
- Update in diagnosis and management of primary aldosteronism
- Diagnosis biomarkers in acute intestinal ischemic injury: so close, yet so far
- Opinion Papers
- Irregular analytical errors in diagnostic testing – a novel concept
- A Black Swan in clinical laboratory practice: the analytical error due to interferences in immunoassay methods
- General Clinical Chemistry and Laboratory Medicine
- Reaching consensus on communication of critical laboratory results using a collective intelligence method
- Stability of routine biochemical analytes in whole blood and plasma/serum: focus on potassium stability from lithium heparin
- GFR estimation based on standardized creatinine and cystatin C: a European multicenter analysis in older adults
- Binding of bromocresol green and bromocresol purple to albumin in hemodialysis patients
- Interlaboratory variability of urinary iodine measurements
- The venous thromboembolic risk and the clot wave analysis: a useful relationship?
- Hematology and Coagulation
- Autovalidation and automation of the postanalytical phase of routine hematology and coagulation analyses in a university hospital laboratory
- Reference Values and Biological Variations
- Indirect method for validating transference of reference intervals
- Differences in levels of albumin, ALT, AST, γ-GT and creatinine in frail, moderately healthy and healthy elderly individuals
- Cancer Diagnostics
- Serum exosomal hnRNPH1 mRNA as a novel marker for hepatocellular carcinoma
- Intragenic hypomethylation of DNMT3A in patients with myelodysplastic syndrome
- Cardiovascular Diseases
- Evaluation of analytical performance of a new high-sensitivity immunoassay for cardiac troponin I
- MEF2C loss-of-function mutation associated with familial dilated cardiomyopathy
- Letter to the Editor
- Hyperuricemia does not seem to be an independent risk factor for coronary heart disease
- Reply to: Hyperuricemia does not seem to be an independent risk factor for coronary heart disease
- Preanalytics of ammonia: stability, transport and temperature of centrifugation
- Influence of delayed separation of plasma from whole blood on Cu, I, Mn, Se, and Zn plasma concentrations
- Copeptin as a diagnostic and prognostic biomarker in patients admitted to Emergency Department with syncope, presyncope and vertiginous syndrome
- Development of an internally controlled quantitative PCR to measure total cell-associated HIV-1 DNA in blood
- Selective changes in cholesterol metabolite levels in plasma of breast cancer patients after tumor removal
- Athletes beware before throwing towels to audiences
Articles in the same Issue
- Frontmatter
- Editorial
- Analytical quality: an unfinished journey
- Reviews
- Update in diagnosis and management of primary aldosteronism
- Diagnosis biomarkers in acute intestinal ischemic injury: so close, yet so far
- Opinion Papers
- Irregular analytical errors in diagnostic testing – a novel concept
- A Black Swan in clinical laboratory practice: the analytical error due to interferences in immunoassay methods
- General Clinical Chemistry and Laboratory Medicine
- Reaching consensus on communication of critical laboratory results using a collective intelligence method
- Stability of routine biochemical analytes in whole blood and plasma/serum: focus on potassium stability from lithium heparin
- GFR estimation based on standardized creatinine and cystatin C: a European multicenter analysis in older adults
- Binding of bromocresol green and bromocresol purple to albumin in hemodialysis patients
- Interlaboratory variability of urinary iodine measurements
- The venous thromboembolic risk and the clot wave analysis: a useful relationship?
- Hematology and Coagulation
- Autovalidation and automation of the postanalytical phase of routine hematology and coagulation analyses in a university hospital laboratory
- Reference Values and Biological Variations
- Indirect method for validating transference of reference intervals
- Differences in levels of albumin, ALT, AST, γ-GT and creatinine in frail, moderately healthy and healthy elderly individuals
- Cancer Diagnostics
- Serum exosomal hnRNPH1 mRNA as a novel marker for hepatocellular carcinoma
- Intragenic hypomethylation of DNMT3A in patients with myelodysplastic syndrome
- Cardiovascular Diseases
- Evaluation of analytical performance of a new high-sensitivity immunoassay for cardiac troponin I
- MEF2C loss-of-function mutation associated with familial dilated cardiomyopathy
- Letter to the Editor
- Hyperuricemia does not seem to be an independent risk factor for coronary heart disease
- Reply to: Hyperuricemia does not seem to be an independent risk factor for coronary heart disease
- Preanalytics of ammonia: stability, transport and temperature of centrifugation
- Influence of delayed separation of plasma from whole blood on Cu, I, Mn, Se, and Zn plasma concentrations
- Copeptin as a diagnostic and prognostic biomarker in patients admitted to Emergency Department with syncope, presyncope and vertiginous syndrome
- Development of an internally controlled quantitative PCR to measure total cell-associated HIV-1 DNA in blood
- Selective changes in cholesterol metabolite levels in plasma of breast cancer patients after tumor removal
- Athletes beware before throwing towels to audiences
