Founded in 1947 in Bethesda,Maryland,USA, AABB (American Association of Blood Banks) is an international non-profit association that brings together various operators in the field of transfusion and cellular medicine. Its list of accredited structures is available online and is regularly updated; accredited structures are inspected every two years.
In pursuit of its original goal of establishing quality standards for blood banks, AABB has defined over the years facultative accreditation standards for transfusion centres, laboratories and the different types of blood banks, among which cord blood banks.
The AABB accreditation is a quality benchmark for private cord blood banks in the USA and Canada.
Good Manufacturing Practice (GMP) regulations are defined by control authorities (in Switzerland Swissmedic, in Italy the Agenzia Italiana del Farmaco (Italian Pharmaceutical Agency) and can thus differ from country to country. GMP regulations generally apply to drugs and medical devices and, specifically, they concern the manufacturing processes for drugs and cellular therapy products, which are treated as drugs.
In addition to the pharmaceutical industry, GMP standards apply indeed to the structures processing and manipulating cells, i.e., to the cell factories, laboratories where cells are not only isolated and stored, but manipulated, grown and modified.
Therefore, GMP standards do not concern cord blood banks, because the type of processing entailed to obtain cord blood stem cells is considered minimum manipulation: blood is concentrated, and red blood cells and plasma are depleted.
Yet, for the sake of providing thorough information, it should be underlined that since 2011 the FDA (Food and Drug Administration) requests compliance with GMP standards from heterologous donation public banks (obligation for a FDA BLA license – Biologics License Application). The European directive 2004/23/CE, moreover, requests the laboratory where cord blood is processed to have a GMP class equal to D.
It is a certification released exclusively in the United Kingdom. All the subjects – banks or laboratories – processing cord blood in the United Kingdom must comply with the requirements established by the Human Tissue Authority (HTA), which posts the updated register of authorised and accredited institutes on its website. Only HTA-accredited centres can provide tissue for therapeutic purposes to the hospitals of the British National Health Service.
The standards defined for tissue banks are aligned with European standards, in particular with Directive 2004/23/CE “EU Directive on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells”.
ISO (International Organization for Standardization) is a very broad quality accreditation that can apply to any company or organisation. An ISO accreditation indicates that the organisation has established documented procedures and that it complies with them.
There are no specific ISO standards for cord blood banks, but these can possess ISO certifications limited to some segments of their activity. The ISO certifications most frequently associated with cord blood banks are: ISO 9001:2008 (quality management systems); ISO 13485 (medical devices); ISO 15189 (medical laboratories); ISO 17025 (testing and calibration laboratories).
JACIE (Joint Accreditation Committee) was founded in 1998 by the International Society for Cellular Therapy (ISTC) and the European Group for Blood and Marrow Transplantation (EBMT). It is a specifically European non-profit organization that has as its mission the accreditation of facilities that provide cellular therapies. The accreditation is carried out in association with FACT.
FACT-JACIE standards currently only apply to stem cells derived from blood sources such as bone marrow and peripheral blood. FACT-JACIE refers to haematopoietic stem cells from cord blood only for the administration (infusion) phases to the patient and preparation to infusion (thawing just before transplantation). For everything relating to the collection, manipulation and storage of cord blood stem cells, reference should be made to the FACT-NetCord standard.
JACIE does not accredit, however, umbilical cord blood banks but focuses on transplant centres that treat patients using cord blood (and other blood-derived cells). The accreditation program focuses on both laboratories that manipulate haematopoietic stem cell (from peripheral blood and marrow) and clinical part (nurses and transplant surgeons). All these units form a transplant program.
In 2011, the JACIE accreditation program was recognized as an exemplary project by the European Commission under the Public Health Program environment.