Accreditations & Licenses

Licensure/Accreditation

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 licenses. In addition to being AABB accredited, we are ISO 9001:2008 certified by BSI, an internationally recognized, quality assessment organization and have AATB accreditation. Our list of licenses and accreditations make Cryo-Cell one of the recognized quality leaders in the field.

License Information:

Accredited as a Cord Blood Bank Facility by 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. 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.

California
Nature:

Tissue Bank License
License for the Production of Biologics (Cord Blood & Menstrual Blood)

Tissue Bank ID# CNC80819
Blood Bank ID # 9707

llinois
Nature:

Tissue bank registration
Sperm bank registration

Registration #2006

New York State Department of Health
Nature:

Comprehensive Tissue Procurement Service
Tissue Processing Facility

Tissue Type:

Hematopoietic Progenitor Cells From Umbilical Cord Blood

ID# SC 068
Originally Issued: 6/98

New Jersey Department of Health And Senior Services
Nature:

Blood Bank License for:
- Blood Collection & Processing
- Cord Blood Component Preparation

License # 2889
Originally Issued: 9/99

Maryland Department of Health and Mental Hygiene Office of Health Care Quality
Nature:

Tissue Bank Permit for:
- Progenitor Cell Bank: Cord Blood
- Reproductive Tissue Bank: Embryo, Reproductive Tissue, Sperm

License #TB1195