Case Studies
Case studies showcase real-world applications of policies and innovations, offering insights into improving outcomes and efficiency. They enhance problem-solving skills, highlight best practices, and engage through storytelling for education and transparency.
Interest(s): Advanced Practice Professionals, Checklists & Forms, Emerging Technology, Finance, HR & Staffing, Innovation, Job Descriptions / Competencies, Legal and Regulatory, Marginal / Increased Risk Organs, Normothermic Regional Perfusion (NRP), Organ Allocation (Offer and Acceptance), Organ Preservation and Perfusion, Organ Transportation / Logistics, Patient Safety, Transplant Financial Coordinator
Organ(s): Heart, Kidney, Liver, Lung
Patient Group(s): Adult
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P5- Pitfalls in Perfusion Pumping and Preservation Practice- One center’s journey to advancing infrastructure and support for organ machine perfusion and preservation technology
Dan
Miller
, BSN, RN, MHA, CSSGB
, Senior Transplant Quality Outcome Specialist
, Hospital of the University of Pennsylvania
The Challenge
Organ perfusion technologies have been available and practiced for over 50 years. These dynamic systems have been proven beneficial to patient clinical outcomes through allowing graft assessment, organ preservation and repair. While machine perfusion technology has made significant medical and technical advancement, Static Cold Storage (SCS) remains the routine standard in clinical practice.1 Our center has participated in several clinical research trials helping to support more standard use of this advancing technology in organ repair and preservation with specific considerations in the donor and potential recipient. Robust internal and external research teams collaborated to support and investigate machine perfusion combining research and transplant staff.
However, as the transplant program began to consider moving machine perfusion and pumping operations into standard operating procedures for donors with specific clinical use cases, the teams were challenged by limited infrastructure to support full integration into clinical and business operations. The technical complexity of the evolving machinery required specialized perfusion staff to support both machine operations and organ specialty care. Additionally, perfusion support services were hindered by workforce reductions and industry limitations making it difficult to recruit, retain, or hire new staff. While the program was able to intermittently use the technology, current staffing models in clinical practice and operations did not support the full-time use and the expanded volume of cases.
The Approach
“Assessing and developing infrastructure and protocol machine perfusion was challenging and complex to navigate and execute within the existing organizational framework. Ultimately leaders formed a working group called “Organ Perfusion Pumping and Preservation” of key stakeholders across all organ groups and disciplines to discuss step-by-step processes and considerations for various organ perfusion pathways and logistics starting with the time of initial organ offer and decision points, through device selection and setup, and beyond final case disposition including cleaning, maintenance, and storage and restocking of the devices and supplies.
During our bimonthly discussions, we aimed to clearly define all staff roles and responsibilities, which was helpful to understand potential barriers, limitations and gaps in practice. We designed workflow process maps in Microsoft Visio for different liver perfusion models such as “back-to-base,” highlighting procedures and circumstances for when and where the organ would be placed on machine perfusion (at the outside hospital or within our own institution). Initial proposals focused on resource mobilization and case logistics by creating pre-departure and arrival checklists (Appendix 1) to support resource mobilization and case logistics of traveling to the donor hospital with the perfusion equipment.
Additional protocols and guidelines were developed through engagement with multiple departments within our health system, including our Electronic Medical Record, Perioperative services, procurement team, laboratory, blood bank, pharmacy, bed management, and finance. We met with these entities individually, fostering collaboration to ensure regulatory compliance and process alignment. We compiled a comprehensive logistics physical binder with our key documents for all to reference during a case, which included the workflow process maps (Appendix 2), checklists, data collection worksheets and specimen forms for perfusate culture and perfusate requisitions.
Further, we modeled and incorporated closed-loop communication into the existing transplant structure through real-time communication tools. Teams utilized WhatsApp, secure email and other methods to ensure ongoing communication throughout the case to focus on case mobilization and logistics, staffing updates, challenges, or delays. Post-case debriefings were utilized to consider opportunities for improvement. Outside of an active case, we also considered logistics for supply storage, inventory, and data management. We created an inventory management tracking tool in Microsoft Excel and implemented a schedule rotation for staff to check specific machine perfusion inventory (Appendix 3).”
The Results
As a result of the initiatives, an organ pumping and perfusion working group was formed in August of 2023. The multidisciplinary team sought to focus their efforts on the operational transition and incorporation of machine perfusion into clinical practice. Strategies were limited by internal staffing and resources, forcing executive maneuvers to consider alternative options for support and infrastructure. In December 2024, leadership was able to secure external support and contracting through external partnerships with local organ procurement organizations (OPO) and commercial vendors to expand resources and operations. Collaborating with the external agencies, we were able to develop standard workflows, communication, and pathways for care operations.
Overtime, organ pumping activities and results were variable based on available staffing, as of December 31st, 2024, abdominal teams were able to complete 33 using various organ perfusion tactics. During this time, organs were pumped and used from within and outside of our donor service areas. Further, procurement teams also facilitated numerous (43) organ offers where perfusion was unable to be implemented due to delay in donor passing or quality of donor organ.
Despite less than 50% of those organ offers for which the team facilitated placing on machine perfusion, the outcome of those organs and patients were exceptional. There were no patient deaths, and organ function was highly regarded with only 1 graft failure out of the 33 organs using perfusion therapy. Additionally, our Scientific Registry of Transplant Recipients (SRTR) Program Specific outcome Organ Offer acceptance ratio for DCD and hard-to-place organs improved respectively of the past two reporting periods.
Insights & Lessons Learned
The overall adoption and integration of machine perfusion technology is hindered by high costs and operational complexities. Similar centers who have identified strategies for implementing machine perfusion also suggest the need to improve machine efficiency, automation, and portability. These principles also fostered market competition and third-party vendor developments. Despite the challenges our center faced, we were able to integrate machine perfusion into clinical operations based on external partnerships and contracting. Furthermore, our development and refining of communication pathways have supported increasing volume and transparency in outcome monitoring through QAPI integration of machine perfusion.
As our transplant program incorporated machine perfusion into clinical practice, we quickly became self-aware of the limitations of internal infrastructure and support needed to be successful. It is our goal in presenting this information that as transplant programs consider implementing machine perfusion technologies, they consider collaborative support from internal and external subject matter experts through consortiums like The Alliance.
Deep collaboration and sharing of experience, knowledge and insight are important to the industry goals of improving health and wellness. However, in order for the professional community to expand clinical applications of pumping and perfusion technologies to all transplant programs, we will need enhanced infrastructure for industry monitoring and oversight. Standardization and transparency in reporting of patient and machine data and financial schemes will be essential to allow the global use of these innovative strategies to benefit all stakeholders, patients, and communities.