Perna, Jessica A

Abstract Purpose The objective of this quality improvement process was to identify quality gaps in compliance with regulatory requirements and reduce the loss of revenue resulting from noncompliance with documentation of single-dose vial waste. Methods This quality improvement initiative employed process mapping and quality gap identification to address challenges related to compliance and revenue generation. A fishbone diagram and the 5 whys technique were used to identify and analyze the root causes of missed waste documentation and workflow inconsistencies. These root causes were categorized into key areas: missing documentation, divergent workflows, inconsistencies, insufficient surveillance, and staffing issues. Leveraging these insights, we developed comprehensive educational resources such as quick reference guides and updated on-the-job training materials for the pharmacy department. Additionally, reliable, reproducible reports were created to monitor waste documentation, facilitating timely interventions whereby technicians were contacted to complete missing documentation within the 96-hour charge capture window. Results This study evaluated a total of 5,801 orders placed from October 1, 2022, to March 31, 2023, for the preimplementation period. Of these 5,801 orders, 803 (13.8%) were missing waste documentation, resulting in a total revenue loss of $362,594 when converted to the average sales price (ASP). For the postimplementation period from April 1 to September 30, 2023, a total of 10,464 orders were inspected for missing waste documentation. Only 181 orders (1.7%) were found to have incomplete waste documentation, resulting in a total revenue loss of $44,343 when converted to ASP. The postimplementation period yielded a revenue capture of $318,250, representing significant improvement in compliance with waste documentation. Conclusion This quality improvement initiative significantly reduced revenue loss from noncompliance with waste documentation for compounded sterile products. Comprehensive education and reliable reporting increased adherence to waste documentation workflows and regulatory compliance.