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Proceedings Paper

Quality control and assurance for validation of DOS/I measurements
Author(s): Albert Cerussi; Amanda Durkin; Richard Kwong; Timothy Quang; Brian Hill; Bruce J Tromberg; Nick MacKinnon; William W. Mantulin
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Paper Abstract

Ongoing multi-center clinical trials are crucial for Biophotonics to gain acceptance in medical imaging. In these trials, quality control (QC) and assurance (QA) are key to success and provide "data insurance". Quality control and assurance deal with standardization, validation, and compliance of procedures, materials and instrumentation. Specifically, QC/QA involves systematic assessment of testing materials, instrumentation performance, standard operating procedures, data logging, analysis, and reporting. QC and QA are important for FDA accreditation and acceptance by the clinical community. Our Biophotonics research in the Network for Translational Research in Optical Imaging (NTROI) program for breast cancer characterization focuses on QA/QC issues primarily related to the broadband Diffuse Optical Spectroscopy and Imaging (DOS/I) instrumentation, because this is an emerging technology with limited standardized QC/QA in place. In the multi-center trial environment, we implement QA/QC procedures: 1. Standardize and validate calibration standards and procedures. (DOS/I technology requires both frequency domain and spectral calibration procedures using tissue simulating phantoms and reflectance standards, respectively.) 2. Standardize and validate data acquisition, processing and visualization (optimize instrument software-EZDOS; centralize data processing) 3. Monitor, catalog and maintain instrument performance (document performance; modularize maintenance; integrate new technology) 4. Standardize and coordinate trial data entry (from individual sites) into centralized database 5. Monitor, audit and communicate all research procedures (database, teleconferences, training sessions) between participants ensuring "calibration". This manuscript describes our ongoing efforts, successes and challenges implementing these strategies.

Paper Details

Date Published: 24 February 2010
PDF: 8 pages
Proc. SPIE 7567, Design and Performance Validation of Phantoms Used in Conjunction with Optical Measurement of Tissue II, 756703 (24 February 2010); doi: 10.1117/12.842755
Show Author Affiliations
Albert Cerussi, Univ. of California, Irvine (United States)
Amanda Durkin, Univ. of California, Irvine (United States)
Richard Kwong, Univ. of California, Irvine (United States)
Timothy Quang, Univ. of California, Irvine (United States)
Brian Hill, Univ. of California, Irvine (United States)
Bruce J Tromberg, Univ. of California, Irvine (United States)
Nick MacKinnon, OneLight Corp. (Canada)
William W. Mantulin, Univ. of California, Irvine (United States)


Published in SPIE Proceedings Vol. 7567:
Design and Performance Validation of Phantoms Used in Conjunction with Optical Measurement of Tissue II
Robert J. Nordstrom, Editor(s)

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