Article

Original Article

Ann Lab Med 2022; 42(2): 150-159

Published online March 1, 2022 https://doi.org/10.3343/alm.2022.42.2.150

Copyright © Korean Society for Laboratory Medicine.

Periodic Comparability Verification and Within-Laboratory Harmonization of Clinical Chemistry Laboratory Results at a Large Healthcare Center With Multiple Instruments

Youngwon Nam, M.D.1,2 , Joon Hee Lee, M.D.1,2 , Sung Min Kim, M.T.2 , Sun-Hee Jun, M.T.2 , Sang Hoon Song, M.D., Ph.D.1,3 , Kyunghoon Lee, M.D.1,2 , and Junghan Song, M.D., Ph.D.1,2

1Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul, Korea; 2Department of Laboratory Medicine, Seoul National University Bundang Hospital, Seongnam, Korea; 3Department of Laboratory Medicine, Seoul National University Hospital, Seoul, Korea

Correspondence to: Junghan Song, M.D., Ph.D.
Department of Laboratory Medicine, Seoul National University Bundang Hospital, 82 Gumi-ro 173beon-gil, Bundang-gu, Seongnam 13620, Korea
Tel: +82-31-787-7691
Fax: +82-31-787-4015
E-mail: songjhcp@snu.ac.kr

Kyunghoon Lee, M.D.
Department of Laboratory Medicine, Seoul National University Bundang Hospital, 82 Gumi-ro 173beon-gil, Bundang-gu, Seongnam 13620, Korea
Tel: +82-31-787-7696
Fax: +82-31-787-4015
E-mail: khlee59023@gmail.com

Received: October 20, 2020; Revised: April 21, 2021; Accepted: September 9, 2021

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background: Results from laboratories using multiple instruments should be standardized or harmonized and comparability-verified for consistent quality control. We developed a simple frequent comparability verification methodology applicable to large healthcare centers using multiple clinical chemistry instruments from different manufacturers.
Methods: Comparability of five clinical chemistry instruments (Beckman Coulter AU5800, Abbott Architect Ci16000, two Siemens Vista 1500, and Ortho Vitros 5600) was evaluated from 2015 to 2019 for 12 clinical chemistry measurements. Pooled residual patient samples were used for weekly verifications. Results from any instrument exceeding the allowable verification range versus the results from the comparative instrument (AU5800) were reported to clinicians after being multiplied by conversion factors that were determined via a linear regression equation obtained from simplified comparison.
Results: Over the five-year study period, 432 weekly inter-instrument comparability verification results were obtained. Approximately 58% of results were converted due to non-comparable verification. Expected average absolute percent bias and percentage of non-comparable results for non-converted and converted results after conversion action were much lower than those for data measured before conversion action. The inter-instrument CV for both non-converted and converted results after conversion action was much lower than that for measured data before conversion action for all analytes.
Conclusions: We maintained within-laboratory comparability of clinical chemistry tests from multiple instruments for five years using frequent low-labor periodic comparability verification methods from pooled residual sera. This methodology is applicable to large testing facilities using multiple instruments.

Keywords: Comparability, Clinical chemistry, Instruments, Verification