Valley Children's Healthcare, Madera, CA, USA Madera, California, United States
Background/Case Studies: Due to the 4-6 hour shelf life to evade potential infectious transmission, the wastage rates for Cryo AHF were consistently exceeding our targets of less than 10% waste per quarter and contributing to increased costs. The FDA has approved Pathogen Reduced Cryoprecipitated Fibrinogen Complex (PRCFC) for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. The local blood center initiated the manufacture of PRCFC from amotosalen/UVA-treated plasma to mitigate transfusion transmission risk with a post thaw shelf life of 5-days. Opportunities for increasing patient safety and decreasing CryoAHF waste were identified.
Study
Design/Methods: Implementation of PRCFC began in November 2021 of the first fiscal quarter of FY2022 (Oct-Dec 2021). Increasing patient safety while decreasing CryoAHF waste was managed as a process improvement project. A retrospective analysis of wastage for CryoAHF vs. PRCFC transfusion was performed for orders placed between 1QFY2021 (October 2020) and 2QFY2023 (March 2023).
Results/Findings: Steps identified in the project plan included product review, acceptance from physician stakeholders, blood utilization committee approval, IT, and procedure updates. The Transfusion Service determines if CryoAHF or PRCFC is used to fill an order based on clinical diagnosis, age, weight, ABO capability, and inventory. The quarterly wastage rate for CryoAHF ranged from 11.3% to 25.8% with an annual average wastage rate of 16.3%. Following the implementation of PRCFC, the annual average wastage rate has decreased to 5.64%. (Table 1) Conclusions: This process improvement project was successful as evidenced by progress and completion reports submitted to change management leadership and positive results on a six-month post implementation survey with physician stakeholders. The ability to store PRCFC thawed for the extended expiration of 5 days for PRCFC compared with 6 hours for CryoAHF has also contributed to a 65% decrease in wastage of this critical blood component. Implementation of a CryoAHF equivalent with an FDA approved level of risk reduction of infectious transmission has allowed our transfusion service to provide a safer source of fibrinogen and other clotting key factors and facilitate a more rapid hemostasis in bleeding patients.
Importance of research: Implementation of a CryoAHF equivalent with an FDA approved level of risk reduction of infectious transmission now allows transfusion services to provide a safer source of fibrinogen and other key clotting factors. The extended expiration of 5 days for pathogen reduced cryoprecipitated fibrinogen complex compared with 6 hours for CryoAHF facilitates a more rapid hemostasis in bleeding patients, decreased wastage of critical blood components, and an overall cost savings.
