title: Validation rules for blood smear revision after automated hematological testing using Mindray CAL-8000.
abstract: BACKGROUND
  This article was aimed to test the use of validation rules for blood smear review after automated hematological testing using Mindray CAL-8000 (two hematological analyzers and one autoslider).
  
  
  METHODS
  This study was based on 1013 peripheral blood samples (PB) referred for routine hematological testing. Results of testing on CAL-8000 were analyzed using both locally derived and International Consensus Group for Hematology (ICGH) validation rules, and then compared with data obtained by optical microscopy (OM). A workflow analysis was also completed.
  
  
  RESULTS
  The overall agreement with locally derived and ICGH criteria was 91% and 85%, but a higher sensitivity was observed for locally derived criteria (0.97 vs 0.95). The percentage of false negative and false positive samples was 2.1% and 7.1% using ICGH criteria, and was 1.4% and 14% using locally defined rules. The throughput of CAL-8000 system was 208 samples/h, with a percentage of OM analysis comprised between 14% and 17%, and sensitivity of 0.97. As regards personnel activity, we estimated 0.8 full-time equivalent (FTE) of technical staff and 0.7 FTE of personnel for clinical validation of data and blood smear review.
  
  
  CONCLUSIONS
  These results show that customization of validation rules is necessary for enhancing the quality of hematological testing and optimizing workflow.
authors.affiliation: Clinical Chemistry Laboratory, Papa Giovanni XXIII Hospital, Bergamo, Italy.
authors.forename: Sabrina
authors.identifier: http://orcid.org/0000-0001-7637-0727
authors.initials: S
authors.lastname: Buoro
authors.affiliation: Clinical Chemistry Laboratory, Papa Giovanni XXIII Hospital, Bergamo, Italy.
authors.forename: Tommaso
authors.initials: T
authors.lastname: Mecca
authors.affiliation: Clinical Chemistry Laboratory, Papa Giovanni XXIII Hospital, Bergamo, Italy.
authors.forename: Michela
authors.initials: M
authors.lastname: Seghezzi
authors.affiliation: Clinical Chemistry Laboratory, Papa Giovanni XXIII Hospital, Bergamo, Italy.
authors.forename: Barbara
authors.initials: B
authors.lastname: Manenti
authors.affiliation: Clinical Chemistry Laboratory, Papa Giovanni XXIII Hospital, Bergamo, Italy.
authors.forename: Giovanna
authors.initials: G
authors.lastname: Azzarà
authors.affiliation: Synlab Italy, S.R.L., Monza, Italy.
authors.forename: Cosimo
authors.initials: C
authors.lastname: Ottomano
authors.affiliation: Section of Clinical Biochemistry, University of Verona, Verona, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Lippi
mesh_terms: D057205:Automation, Laboratory / Q000592:standards*; D002648:Child; D005260:Female; D006403:Hematologic Tests / Q000592:standards*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
keywords: automated count; hematological testing; optical microscopy; rules