Redesigning Transplant Organ Labeling: an Innovative Approach to Improve Patient Safety.

Background: Over 28,000 organ transplants are performed in the US annually and labels used for procurement are still completed by hand. Organ transplantation lacks a systematic approach to evaluate potential vulnerabilities in the labeling and identification process. A comprehensive review of organ procurement safety incidents identified “labeling” as the most common incident. As part of a larger HHS Innovation Initiative, we conducted a three phase project to improve the organ labeling and identification process: (1) Risk assessment to identify and rank failures and underlying causes (2) Development and testing of a tablet application (“app”) to generate and wirelessly print standardized, barcoded labels and Donor ID bands; and (3) Use of laboratory-based simulations to assess organ procurement workflow with new “app.” Methods: A Failure Mode Effects and Criticality Analysis (FMECA) was conducted for the deceased donor abdominal organ procurement process focused on steps related to labeling and organ identification. UNOS representatives, clinicians, and staff from selected Organ Procurement Organizations (OPOs) and the local Transplant Center (TC) contributed to the creation of a comprehensive process map (42 individuals total). Potential failures for each process step were identified, scored, ranked by criticality, and then used to inform the design of the “app.” We conducted laboratory-based simulations to test integration of the “app” and wireless printer into procurement process, facilitated debriefings with participants to optimize workflow redesign, and human factors usability analysis. Results: The FMECA revealed a total of 146 potential failures from 60 identified process steps. Key “high criticality” risks include: Accuracy of donor information on the label; Identification of the laterality of a kidney; and Validation of receipt of the right donor organ for the right recipient. Significant features of the “app” include a double-entry to verify accuracy of donor information, standardized label format, and ability to wirelessly print labels, Donor ID bands, and shipping manifest for each procured organ at “bedside.” Conclusions: The “app” impacts 65% of the top 10 identified high criticality risks and should mitigate labeling errors that lead to additional testing, wrong donor organ-wrong recipient errors, and discarding of organs due to identification errors. Further validation of new technology must be conducted before implementation nationwide.