Quality & Compliance

Best Practices and Regulatory Compliance. O.N. Diagnostics’ research and clinical services are governed by internal systems that strive for the highest standards in quality and safety. Our research services comply with state and federal regulations for the Protection of Human Subjects (CA-HSC-24170, 45 CFR Part 46) and Institutional Review Boards (21 CFR Part 56), and lead investigators have completed OHRP course work in human subjects research protection. Our clinical services are compliant with the standards of the Health Insurance Portability and Accountability Act (HIPAA) to ensure appropriate protection of electronic protected health information. All our analysts are uniquely trained engineers with expertise in both medical image analysis and finite element analysis, and must pass a rigorous training certification process.

For our research services, our rigorous quality standards conform to international (ICH-E6) and FDA (21 CFR Part 11, 312, 314) Good Clinical Practices. A comprehensive set of standard operating procedures (SOPs) direct clinical research activity and software development within the company, and are subject to annual audits by external auditing firms with specific expertise in medical devices. These systems provide the necessary audit trail to support clients in the event of a review by a regulatory agency or IRB.

As a medical device manufacturer, O.N. Diagnostics has also established extensive quality systems conforming with FDA current Good Manufacturing Practices (21 CFR Part 820). Development and updates to our software products follow strict guidelines for medical devices, including verification and validation testing with multiple levels of redundancy prior to release.

Quality Control Systems. Our quality control systems span from receipt of a CT scan to transmittal of results. For our research studies, our proprietary image-management software parses scan meta-information for acquisition and reconstruction parameters in order to detect such discrepancies as duplicate scans, non-standard reconstructions, and machine/protocol changes during longitudinal studies. We employ analytic quality control protocols and outlier analyses for all completed data sets to ensure data integrity (completeness and accuracy) and to identify any suspect cases for appropriate resolution and, if necessary, re-analysis.

For our clinical services, results for each patient CT scan are peer-reviewed to ensure quality and consistency; any suspect cases are scrutinized and repeated if necessary. Our image-management software tracks all scans from receipt to medical report transmission to ensure timely delivery of all medical reports. An isolated clinical network and automated routing and tracking ensure that all electronic protected health information is secure while at O.N. Diagnostics and appropriately deleted after receipt of the medical report.