Over the last six decades, the underlying rationale for retaining records has undergone significant changes in response to the development of quality management, technological innovation, and the expansion of biologics, including blood and blood components. While the underlying paradigms that necessitate record management have evolved, the record creation and retention method have remained static until recently. Rapid advances in the development and employment of electronic records have the potential to upend traditional methods of record entry and retention. Outdated modes of media retention (microfiche, microfilm, floppy disks, CD-ROM, etc.) may become irretrievable due to degradation and/or access to the technology is made obsolete. Long-term (sometime indefinite) retention of aging records has increasingly become costly, burdensome, and ultimately non-value added activity for blood centers. The ability to digitize existing media for retention to local or cloud-based drives can curtail the burden of maintaining thousands of physical records, some in perpetuity.This session will review and evaluate a large blood center's perspective and experience in transitioning from a paper-based to an electronic records management system. It will summarize opportunities and obstacles in transitioning away from paper based systems, highlighting its advantages and limitations. Finally, the session will evaluate a blood center's experience in bringing its records management process in house..
Identify the underlying statutory and regulatory requirements pertaining to electronic records management.
Assess current records management systems, evaluating inefficiencies in process while demonstrating opportunities to streamline processes and improve costs.
Produce and recommend a records management approach tailored to the individual blood center's needs.
Calculate the advantages, limitations, and risks associated with transitioning to an electronic records management system or localizing records management processes away from third party vendors.
Vice President, Quality System and Regulatory Services,