Quality Assurance System Using Statistical Process Control: An Implementation for Image Cytometry

Aims: Optical technologies have shown some promise for improving the care of cervical neoplasia. We are currently evaluating fluorescence and reflectance spectroscopy and quantitative cyto‐histopathology for cervical neoplasia screening and diagnosis. Here we describe the establishment and applicati...

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Main Authors: David Chiu, Martial Guillaud, Dennis Cox, Michele Follen, Calum MacAulay
Format: Article
Language:English
Published: Wiley 2004-01-01
Series:Cellular Oncology
Online Access:http://dx.doi.org/10.1155/2004/794021
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author David Chiu
Martial Guillaud
Dennis Cox
Michele Follen
Calum MacAulay
author_facet David Chiu
Martial Guillaud
Dennis Cox
Michele Follen
Calum MacAulay
author_sort David Chiu
collection DOAJ
description Aims: Optical technologies have shown some promise for improving the care of cervical neoplasia. We are currently evaluating fluorescence and reflectance spectroscopy and quantitative cyto‐histopathology for cervical neoplasia screening and diagnosis. Here we describe the establishment and application of a quality assurance (QA) system for detecting system malfunctions and assessing the comparability of four image cytometers used in a multicenter clinical trial. Methods: Our QA system involves three levels of evaluation based on the periodicity and complexity of the measurements. We implemented our QA system at three image cytometers at the British Columbia Cancer Agency and one at M.D. Anderson Cancer Center. The measurements or tasks were performed daily, monthly, and semi‐annually. The current and voltage of the lamp, the calibration image characteristics, and the room temperature were checked daily. Long‐term stability over time, short‐term variability over time, and spatial response field uniformity were evaluated monthly. Camera linearity was measured semi‐annually. Control charts based on statistical process control techniques were used to detect when the system did not perform optimally. Results: Daily measurements have shown good consistency in room temperature, lamp and calibration behaviour. Monthly measurements have shown small coefficients of variation between and within the four devices. There have been greater differences between sessions than within sessions. Comparability among the four systems is reasonably good. Semi‐annual measurements have shown stable camera linearity. QA events were detected using the QA system. Multiple examples of event detection leading to correction of system malfunction are described in this report. Conclusions: QA programs are critical for ensuring data integrity and therefore for the conduct of multicenter clinical trials.
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spelling doaj-art-c71fc01848c9474fa2476165920c71c92025-02-03T01:00:49ZengWileyCellular Oncology1570-58701875-86062004-01-0126310111710.1155/2004/794021Quality Assurance System Using Statistical Process Control: An Implementation for Image CytometryDavid Chiu0Martial Guillaud1Dennis Cox2Michele Follen3Calum MacAulay4Department of Cancer Imaging, British Columbia Cancer Agency, Vancouver, BC, CanadaDepartment of Cancer Imaging, British Columbia Cancer Agency, Vancouver, BC, CanadaDepartment of Statistics, Rice University, Houston, TX, USADepartment of Gynecology, The University of Texas M.D. Anderson Cancer Center, Houston, TX, USADepartment of Cancer Imaging, British Columbia Cancer Agency, Vancouver, BC, CanadaAims: Optical technologies have shown some promise for improving the care of cervical neoplasia. We are currently evaluating fluorescence and reflectance spectroscopy and quantitative cyto‐histopathology for cervical neoplasia screening and diagnosis. Here we describe the establishment and application of a quality assurance (QA) system for detecting system malfunctions and assessing the comparability of four image cytometers used in a multicenter clinical trial. Methods: Our QA system involves three levels of evaluation based on the periodicity and complexity of the measurements. We implemented our QA system at three image cytometers at the British Columbia Cancer Agency and one at M.D. Anderson Cancer Center. The measurements or tasks were performed daily, monthly, and semi‐annually. The current and voltage of the lamp, the calibration image characteristics, and the room temperature were checked daily. Long‐term stability over time, short‐term variability over time, and spatial response field uniformity were evaluated monthly. Camera linearity was measured semi‐annually. Control charts based on statistical process control techniques were used to detect when the system did not perform optimally. Results: Daily measurements have shown good consistency in room temperature, lamp and calibration behaviour. Monthly measurements have shown small coefficients of variation between and within the four devices. There have been greater differences between sessions than within sessions. Comparability among the four systems is reasonably good. Semi‐annual measurements have shown stable camera linearity. QA events were detected using the QA system. Multiple examples of event detection leading to correction of system malfunction are described in this report. Conclusions: QA programs are critical for ensuring data integrity and therefore for the conduct of multicenter clinical trials.http://dx.doi.org/10.1155/2004/794021
spellingShingle David Chiu
Martial Guillaud
Dennis Cox
Michele Follen
Calum MacAulay
Quality Assurance System Using Statistical Process Control: An Implementation for Image Cytometry
Cellular Oncology
title Quality Assurance System Using Statistical Process Control: An Implementation for Image Cytometry
title_full Quality Assurance System Using Statistical Process Control: An Implementation for Image Cytometry
title_fullStr Quality Assurance System Using Statistical Process Control: An Implementation for Image Cytometry
title_full_unstemmed Quality Assurance System Using Statistical Process Control: An Implementation for Image Cytometry
title_short Quality Assurance System Using Statistical Process Control: An Implementation for Image Cytometry
title_sort quality assurance system using statistical process control an implementation for image cytometry
url http://dx.doi.org/10.1155/2004/794021
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