Accredited as a Cord Blood Bank Facility by AABB.
In May 2005, the U.S. Food and Drug Administration (FDA) began regulating family cord blood banks through promulgation of 21 CFR 1271, current Good Tissue Practices. Beyond the federal government, several states (CA, IL, New York, New Jersey and Maryland) have applicable regulations. In addition, several organizations offer accreditation to their standards—AABB is one.
Cryo-Cell is FDA registered
, cGMP-/cGTP-compliant and is licensed in all states requiring licensure. Besides being AABB accredited
, Cryo-Cell is also the first U.S. (for private use only) cord blood bank to receive FACT accreditation
for adhering to the most stringent cord blood quality standards set by any internationally recognized, independent accrediting organization. In addition, Cryo-Cell is ISO 9001:2008 certified
by BSI, an internationally recognized, quality assessment organization. Our list of licenses and accreditations make Cryo-Cell one of the recognized quality leaders in the field.
Accredited as a Cord Blood Bank Facility by FACT.
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. Prospective clients and medical practitioners view AABB accreditation
as one of the most important criteria when choosing or recommending a cord blood bank. By successfully meeting the rigid standards set by the AABB, Cryo-Cell demonstrates its commitment to third party evaluation, total quality management and excellence in our field.
Accreditation follows an intensive on-site assessment by specially trained AABB assessors who evaluate internal policies and procedures and establish that the level of medical, technical and administrative performance within the facility meets or exceeds the standards set by the AABB. The assessment includes cell processing, calibration and validation of processing and storage equipment/instrumentation, cryopreservation records, document control, inspection and testing, training of laboratory technologists, sample identification and traceability, and verification of cord blood units when released from storage.
Since its inception in 1947, the association has grown to represent much more than the "American Association of Blood Banks". The association instituted a name change in 2005 to more accurately reflect its interests and diverse membership, and is now known only by its acronym, AABB. To help people understand who they are and what they do, AABB adopted the tag line: "Advancing Transfusion and Cellular Therapies Worldwide." AABB remains committed to its core objectives to provide high standards of safety for patients, donors and facilities. AABB member institutions displaying the AABB accreditation logo are recognized throughout the world for providing quality products and services.
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.
Cryo-Cell was awarded FACT
(the Foundation for the Accreditation for Cellular Therapy) accreditation, after demonstrating compliance through an extensive inspection and auditing process with the NETCORD-FACT International Standards for Cord Blood Collection, Processing, Testing, Banking, Selection and Release. This accreditation applies to all services and facilities that were inspected by FACT, related to cord blood collection, processing, testing, cord blood banking, selection and cord blood release processes for clinical administration.
In December 1994, the International Society for Cellular Therapy (ISCT) and the American Society for Blood and Marrow Transplantation (ASBMT) merged their Standards into a single document covering all aspects of hematopoietic cell therapy (collection, processing, and transplantation). The two societies established FACT in order to develop a voluntary Inspection and Accreditation Program based on the joint Standards. FACT promotes quality medical and laboratory practice of cellular therapy through its peer-developed standards and voluntary inspection and accreditation program.
In 2000, recognizing the global impact of cord blood banking and transplantation, FACT partnered with NetCord to develop international standards for cord blood collection, processing, testing, banking, selection and release. The NetCord foundation is an international network of non-profit public cord blood banks created to promote the establishment of high quality cord blood banks and improve the quality of cord blood products through study and research.
Tissue Bank ID# CNC80819
Blood Bank ID # 9707
New York State Department of Health
ID# SC 068
Originally Issued: 6/98
New Jersey Department of Health And Senior Services
License # 2889
Originally Issued: 9/99
Maryland Department of Health and Mental Hygiene Office of Health Care Quality