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Comparison of traditional statistical quality control using commercially available control materials and two patient‐based quality control procedures for the ADVIA 120 Hematology System
Author(s) -
Vanyo Lourdes C.,
Freeman Kathleen P.,
MeléndezLazo Antonio,
Teles Mariana,
Cuenca Rafaela,
Pastor Josep
Publication year - 2018
Publication title -
veterinary clinical pathology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.537
H-Index - 51
eISSN - 1939-165X
pISSN - 0275-6382
DOI - 10.1111/vcp.12645
Subject(s) - quality assurance , quality (philosophy) , medicine , control (management) , hematology analyzer , hematology , quality control , reliability engineering , external quality assessment , medical physics , statistics , computer science , mathematics , pathology , engineering , artificial intelligence , philosophy , epistemology
Background Quality control procedures are an important part of the overall quality assurance for production of accurate and reliable hematologic results. Objectives This study aimed to validate a quality control material‐based procedure and assess two patient‐based quality control procedures (repeat patient testing [ RPT ] and average of normals [AoN]) with the ADVIA 120 Hematology System. Methods Requirements for quality control procedures were obtained with the computerized statistical and quality program, EZR ules3. The procedures were evaluated comparing the probability of error detection (Ped), probability of false rejection (Pfr), and sigma metrics. Results All three of the quality control procedures could be applied with 1‐3s control rules, achieving the desired quality requirements. Validation of the quality control materials achieved values for Ped and Pfr of ≥90% and 0%, respectively. Patient‐based procedures obtained a ≥85% Ped and a 0% Pfr, except for platelets in the AoN procedure, which achieved a 77% Ped. The RPT achievable total errors were similar to those of the traditional quality control materials and the AoN procedures, except for platelets, which had an achievable total error of 75%. Conclusions Patient‐based procedures are suitable for veterinary laboratories. The RPT approach may benefit laboratories with limited budgets and low hematology caseloads. The AoN procedure may benefit laboratories with higher hematology caseloads.