Jennifer Garfinkel
AABB
publicrelations@aabb.org

ICMS and AABB Collaborate to Help Improve Safety for Patients Receiving Autologous Adult Cell-Based Therapies

With AABB assistance, ICMS to establish voluntary standards and a global accreditation program for clinics and facilities that collect, process and administer autologous adult cells


Recognizing that procedures involving autologous cellular therapies are increasingly performed outside of the stem cell transplant setting with demand driven by patients and physicians alike, the International Cellular Medicine Society (ICMS) and AABB (formerly the American Association of Blood Banks) today announced that AABB will be assisting ICMS in the development of quality-based, voluntary standards for the collection, processing and administration of autologous adult cells. Upon adoption of the ICMS standards by ICMS, AABB will provide global accreditation services against the ICMS standards to foster responsible innovation within the field and promote patient safety.

"As more and more ground-breaking cellular therapy treatments become available, it is imperative that there are controlled policies and processes in place at the clinics and facilities where the treatment is rendered," said Ricardo Rodriguez, MD, president of the ICMS Board of Directors. "The ICMS standards and global accreditation program are being established to help ensure the safest possible patient outcomes."

The ICMS and AABB will work jointly to develop ICMS voluntary standards for the collection, processing and administration of autologous adult cells. The ICMS Standards for Cell-Based Medicine Facilities will be developed using policies and processes similar to those used to establish AABB's voluntary standards. The process will include a public comment period, review of those comments by the ICMS Standards Committee and final approval by the ICMS Board of Directors.

The ICMS Accreditation Program will be based on requirements contained in the ICMS Standards for Cell-Based Medicine Facilities. AABB will be responsible for administering the accreditation program, which will be modeled after AABB's existing accreditation program. Accreditation will be effective for a two-year cycle following award unless a facility fails to maintain compliance with the ICMS standards.

"AABB is recognized worldwide for its accreditation program and commitment to quality in transfusion medicine and cellular therapies," said Karen L. Shoos, JD, CEO of AABB. "We are enthusiastic about our collaboration and look forward to joining with the ICMS to advance the practice of cellular therapies and optimize patient and donor care and safety."

About the International Cellular Medicine Society
The ICMS is a 501(c)(3) nonprofit professional medical organization that is focused on the development of standards for the evaluation of point-of-care, cell-based treatments worldwide. With over 3,500 members from over 35 countries, the ICMS is a global leader in patient safety through strict evaluation of treatments and rigorous oversight of clinics and facilities providing cell-based medical procedures. The ICMS maintains an independent Institutional Review Board and manages a comprehensive Treatment Registry that tracks patient outcomes. More information can be found at www.cellmedicinesociety.org.

About AABB
AABB is an international, not-for-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies. The association is committed to improving health by developing and delivering standards, accreditation and educational programs that focus on optimizing patient and donor care and safety. AABB membership consists of nearly 2,000 institutions and 8,000 individuals, including physicians, nurses, scientists, researchers, administrators, medical technologists and other health care providers. Members are located in more than 80 countries. For additional information, please visit www.aabb.org.

The AABB Accreditation program promotes the highest standards of care for both patients and donors in all aspects of blood banking; transfusion medicine; relationship testing; and cellular therapies, including hematopoietic progenitor cells, umbilical cord blood and other somatic cells. AABB's Accreditation Program has been accredited by the International Society for Quality in Health Care (ISQua), a designation held by only two accrediting bodies in North America. In June 1995, and most recently in May of 2008, AABB was granted "deemed status" as an accrediting organization under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).