In the midst of tremendous growth, FACT announced its plan to pursue independent operational status by the end of 2021. FACT has responded to progress and advancements in cellular therapy during its storied 25-year relationship with the University of Nebraska Medical Center, and future opportunities for the organization motivated the FACT Board of Directors to make this change. As an independent non-profit organization, FACT will have greater freedom to operate in a manner that allows it to rapidly and nimbly make changes as needed to pursue its mission to improve the quality of cellular therapy through peer-developed standards, education, and accreditation for the benefit of patients.
In the official news release on April 5, 2021, leaders of FACT and UNMC expressed their excitement for the future of FACT:
“The relationship between UNMC and FACT is an incredible story of a mutually beneficial collaboration between the international field of cellular therapy and the University. Both UNMC and FACT can take pride in its success.” – Dr. Phyllis Warkentin, FACT Chief Medical Officer
“Twenty-five years ago, UNMC led efforts to form FACT to meet the need for professional standards across the field of hematopoietic cell transplantation. In that quarter-century, UNMC and FACT have enjoyed a long and successful partnership, and we are proud of FACT’s many successes and achievements in its respective fields of expertise. As FACT moves forward as an independent entity, UNMC wishes it nothing but the best, and we expect FACT will continue to grow and achieve greatness in the years to come.” – Doug Ewald, UNMC Vice Chancellor for Business, Finance and Business Development
“This transition represents an incredibly timely opportunity to allow FACT to expand our reach in the cellular therapy field nationally and internationally. As President, I am extremely excited to lead FACT at this transformational time.” – Dr. Catherine Bollard, FACT President
FACT’s training and development program’s purpose is to respond to the current needs of inspectors and organizations, providing extensive opportunities for all skill levels in all corners of the world. Recognizing that education is as important as standards and accreditation within FACT’s mission to promote quality in cellular therapy, the office has welcomed Roxanne Alter, M.S., MLS (ASCP)cm as the Director of Education.
Roxanne received her Bachelor’s Degree from the University of Missouri at Kansas City and continued her education in the Medical Technologist Program at Research Medical Center in Kansas City. She worked as a medical technologist in Blood Bank and Hematology for several years. In 1985, she took a position at UNMC working for Dr. James Armitage in the Autologous Bone Marrow Transplantation designing a laboratory to evaluate products for transplant. She received her Masters of Science Degree under the direction of Dr. Dennis Wiesenberger publishing the thesis “In-Vitro Clonogenic Monitoring Peripheral Blood Stem Cell Collections following Interleukin-3 administration.” Ms. Alter was offered a faculty position as an Assistant Professor in the School of Allied health, designing curriculum and evaluating educational outcomes for Medical Laboratory Scientists and other health professionals. After twenty years in education, she became the Nebraska State Biosafety Officer and inspected clinical laboratories across the state. Roxanne Alter has a wealth of experience, which will serve her well in her new role as Director of Education.
FACT-accredited organizations continue to grow by number, geography, and complexity. To maintain and build upon the support provided by FACT since its inception 23 years ago, the office has welcomed three talented individuals to the accreditation office.
Nicole Gallardo joins FACT as an Administrative Associate. Originally from Germany, Nicole completed Vocational Training in Wholesale and Foreign Trade in Bremerhaven, Germany in 1992. Shortly after, Nicole moved to the United States and worked at the Richdale Property Management Group as an auditor. In 2007, Nicole accepted a position at UNMC’s College of Pharmacy as an Office Associate where she worked until joining the FACT team in the summer of 2018. In 2015, Nicole graduated from the University of Nebraska – Omaha (UNO) with a certificate in Public Management, and in May 2019, Nicole will graduate from UNO with a Bachelor’s Degree in Multidisciplinary Studies with a concentration in General Administration, a milestone accomplishment.
Sue Peters joins FACT as an Accreditation Coordinator. Sue is an ASCP certified Medical Laboratory Scientist, with extensive experience at the clinical microbiology laboratory at Nebraska Medicine, where cultures from cellular therapy products are performed, as well as cultures from transplant patients. She has also worked in the Microbiology/Molecular Department at the Nebraska Public Health Laboratory, where she gained experience in identifying strains of influenza, foodborne pathogens, and bioterrorism organisms. There, she also had the unique experience of working in the Biocontainment Unit with Ebola patients. Sue then transitioned to the role as an Infection Preventionist at Nebraska Medicine, and from there as a microbiology supervisor at a biotechnology company before joining the FACT team in October 2018.
Elda Nazario joins FACT as an Accreditation Coordinator. Originally from Sabana Grande, Puerto Rico, Elda attended college at the Interamerican University in Puerto Rico, and graduated with a bachelor’s degree in Biology in 2002. In 2007, Elda graduated from Medical Technology School and worked as a Medical Laboratory Scientist in Puerto Rico for approximately ten years. In 2016, Elda moved to Omaha, Nebraska and worked as a Medical Laboratory Scientist at the Nebraska Medicine Laboratory at the Oakview Medical Building, and in October 2018, Elda accepted a position at FACT. As a fluent Spanish-speaking Accreditation Coordinator, Elda will be integral to FACT’s initiatives in Latin America.
A testament of FACT leadership’s dedication to its accredited organizations and volunteer inspectors is the strong infrastructure provided at the FACT accreditation office in Omaha, Nebraska. FACT staff members provide executive guidance, implementation strategies, committee support, and, most importantly, guidance to organizations and inspectors. All of these activities are directed by and accomplished for volunteer committees of experts, who are deserving of support that matches their contributions.
FACT-accredited organizations continue to grow by number, geography, and complexity. To maintain and build upon the support provided by FACT since its inception 20 years ago, the office has welcomed four talented individuals to the accreditation office.
Suzanne Clabaugh joins FACT as an Accreditation Coordinator. In her previous employment, she managed an academic research laboratory for UNMC and Wright State University focused on T-Cell homeostasis and Interleukin 2. Suzanne has proven to be quite productive, and is responsive to her organizations’ and inspectors’ needs, “I enjoy my work as a coordinator because it gives me the opportunity to interact with many different people in locations around the world, and it challenges me.” She encourages organizations to make good use of their coordinators’ services. “We are here to help in any way we can, and everything runs more smoothly when we have an open and easy, interactive relationship.”
Cassie Kennedy, a recent graduate from the University of Iowa, is a FACT Accreditation Coordinator. While enrolled in the Biomedical Engineering program, she worked with pulmonary clinical research studies. She is helpful by nature, and enjoys guiding the applicant through the accreditation process. “I learn something new and interesting every day,” says Cassie. Her advice to applicants is to use the field on the Compliance Application that is available for entering applicable document names and page numbers as evidence of compliance. “This field is optional, but including relevant SOPs and page numbers is helpful to both the applicant and the inspector.”
Another new FACT Accreditation Coordinator, Dina Becirovic, previously worked at Creighton University’s Department of Preventive Medicine – Hereditary Cancer Research Center and was responsible for maintaining the integrity and viability of over 50,000 biological specimens. Dina is a forward-thinking individual, and what she likes about her current role, and FACT in general, is the interdisciplinary collaborative effort and process improvement to promote patient safety and provide quality patient care. “Additionally, I appreciate the knowledge and fairness of current leadership and the futuristic outlook on reaching more organizations to ensure patient safety.” She suggests applicants and inspectors build and capitalize on working relationships with their FACT Accreditation Coordinators.
Mikaela VanMoorleghem, FACT’s Education and Training Coordinator, is responsible for developing and administering the growing educational program for FACT inspectors and applicants. Her entire career has been dedicated to education, formerly in the secondary and collegiate environments. “The medical education field has proven to be a very welcome challenge for me. I am learning so much and I find that each day is completely different.” Mikaela has risen to the challenge, increasing FACT’s offerings for training and expanding collaborations with other societies. “I also enjoy traveling for FACT and meeting so many talented people throughout the world. I encourage inspectors to take advantage of opportunities to perform inspections and learn from each other, understand different perspectives, and enjoy different cultures around the world.”
A common thread throughout the perspectives of all of FACT’s new employees is the enjoyment they get from working with the FACT community – at applicant programs and with the inspectorate. FACT staff admires everyone who has contributed to the mission of quality cellular therapy and is proud to work with you.