Vitalant San Luis Obispo, California, United States
Background/Case Studies: A platelet aggregate rejection is when platelet to platelet adhesion causes visible “clumps” in a platelet component resulting in discard. Vitalant’ s platelet aggregate rejection rate (rejected prior to distribution) increased by 75% between Q2 2021 and Q4 2021. This increase resulted in unexpected costs associated with collection and processing of products that could not be released and impacted overall product availability.
Study
Design/Methods: A cross-functional team was utilized to understand inputs and contributing factors associated with the platelet aggregates, and to derive sustainable countermeasures for improvement. The team quickly determined the primary driver of the increased rate was in one region, with a second region observing a spike in aggregates in Q4 2021. First, a process flow map was created to identify contributing factors within the process. Root Cause Analysis was performed using the Ishikawa (fishbone) method. Nominal Group Technique was used to narrow the causes to the critical few. The main causes identified were temperature variations, donor related factors, collection parameters, variation in inspection and aggregate resolution methods. The team created an improvement plan specifically targeting these causes. Improvement actions began implementing in Q2 2022.
Results/Findings: Implemented improvements included re-alignment to best practices with automated collections by observing aggregates at critical points in the collection process and increasing anticoagulant ratio. There was new focus on a standardized approach in both collections and production regarding inspection and resting process. Strategic adjustments were made to improve air flow and temperature. A new monitoring report and new standard criteria of acceptability were developed assessing size and number of aggregates. These efforts created heightened awareness and communication about aggregate assessments and the impact on discards across the organization. Though not one single factor was identified as the cause, the combined improvement efforts helped decrease the rate of platelet aggregate rejects significantly (p < 0.05). The August – October 2021 reject rate was 1.01%. The same period in 2022 resulted in a rejection rate of 0.54% (Fig 1). This lower rate is being sustained and monitoring continues. Conclusions: Many factors contribute to the formation of aggregates in platelets. The observed increase in Q2 2021 is still under investigation related to the potential relationship between COVID-19 vaccinations or other factors. Developing the learning and sharing of best practices across regions was important in helping to minimize regional variation. Because of the subjective nature of the visual inspection process, employee turnover can greatly impact the discard rate. Creating a well-established, standardized inspection criteria can be one key action toward sustainment.
Importance of research: Blood banking has faced difficulties in dealing with platelet aggregates formed during collection, processing, or storage. Aggregates vary in size and number, some disappear or persist throughout storage. No specific causes of this phenomenon have been identified, making it challenging to implement prevention and mitigation strategies. The objective of this study is to share the experience of a large US blood center and describe the outcome of implementing various new mitigation measures.
