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Testing for transplantation has previously been performed by outside laboratories, with results coming to VUMC in a PDF format that has to be scanned into the medical record. Results from HIL will be fully integrated into the electronic health record system.

“It’s very difficult for physicians and nurses to manage the complex information from transplantation testing in a scanned PDF,� Ramon said. “Having the data electronically available will make it easier for our clinicians to manage the results, do data mining, compare protocols, evaluate transplant survival … and improve the service we provide to the patient.�

Having in-house transplantation testing is anticipated to reduce test turnaround times to approximately 24-48 hours.

In its first phase of operations, HIL will conduct clinical tests for hematopoietic stem cell transplantation and risk for certain autoimmune diseases and adverse drug reactions. After optimizing its processes, HIL will begin solid organ transplantation testing during the second and third phases of its implementation, Ramon said. In the long term, once the lab has expanded to fully support the Vanderbilt Transplant Center, it will open its services to other institutions that need histocompatibility testing for their patients.

Histocompatibility testing determines the “match� between transplant donors and recipients.

It focuses on human leukocyte antigen (HLA) proteins, which are located on the surface of most cells and are used by the immune system to distinguish “self� from “nonself.� HLA matching is critical for minimizing or avoiding transplant rejection and complications like graft-versus-host disease. It is also important in assessing risk for some autoimmune diseases and adverse reactions to certain medications, as specific HLA types are associated with higher risk.

HLA proteins are encoded by a complex of genes with the highest variability (polymorphism) in the human genome. HLA testing involves fully sequencing the HLA genes.

“Today we know that there are more than 40,000 different HLA variants. The polymorphism is massive,� Ramon said.

“HLA testing is about providing clinicians with the information they need to choose the best donor for our patients having stem cell and solid organ transplants,� said Elizabeth Sunderhaus, PhD, associate medical director of HIL and assistant professor of Pathology, Microbiology and Immunology.

Testing by HIL also continues posttransplant to monitor the development of antibodies associated with transplant rejection.

“We’re responsible for being a warning signal that alerts clinicians about changes that may be related to rejection,� Sunderhaus said. “And going forward, having all of the data in house will allow clinicians to data mine and ask questions about which therapies work in certain situations. It will provide research opportunities to improve both the lives of our patients and outcomes in transplantation.�

Efforts to bring HLA testing to VUMC began about eight years ago as part of the expansion project for Vanderbilt Medical Laboratories. Ramon joined VUMC in November 2022 to develop and implement plans for HIL.

Ramon has more than 30 years of experience in HLA testing. He received accreditation as an HLA laboratory director at Northwestern University, then served as a director at the University of Michigan, Stanford University and Mayo Clinic before coming to VUMC.

Ramon said the Vanderbilt Transplant Center’s reputation and volume attracted him, along with the challenge of “bringing a brand-new lab to life from scratch.�

Sunderhaus said she “fell in love with HLA� during her graduate school training at Oregon Health & Science University, where a lab director shadowing experience determined her career path. She later worked in research at ClinImmune Cell & Gene Therapy in Aurora, Colorado, where she obtained patents on HLA gene editing to potentially treat autoimmune diseases, and then completed her training as a clinical laboratory director at the University of Rochester. She joined VUMC last year.

In addition to Ramon and Sunderhaus, HIL team members include a manager, two lead technologists and 12 technologists. HIL received accreditation from the American Society of Histocompatibility and Immunogenetics (ASHI) in May.

The accreditation process started in September 2023 with the development of standard operating procedures and optimization of every reagent and piece of equipment used for testing, Ramon said. ASHI evaluated the laboratory’s procedures and compared its results for hundreds of “blind� samples to results from the same samples tested by other ASHI-accredited labs.

“This has been a massive effort with many, many people…from IT to every component of the pathology department to nurses and physicians in different transplant settings that have all been collaborating with us,� Ramon said.

“As one of the largest transplant centers in the U.S., having our own HLA lab will allow us to provide the extraordinary clinical care for which VUMC is known, but also support research that addresses the needs of transplant patients throughout the world,� said Seth Karp, MD, H. William Scott Jr. Professor of Surgery and chair of the Section of Surgical Sciences. “Establishing this lab at VUMC is the culmination of significant investment from the institution and individual efforts of many members of our community.�

HIL team members include Nebila Abdulwahab, Jennifer Barbuto, Sharlie Brown, Angela Busacco, Mimi Cathers, Jesse Day, Sidnee Freeman, Nevin Ghettas, Danielle Hall, Brenda Issangya, Mary Kelley, Joey Schneider, Christopher Stacy and Brookelynn Tenison.

Provided by Vanderbilt University Medical Center.