Accreditation of Cord Blood Banks
Unlike other blood banks, that have had specific guidelines and regulations in place for many years, cord blood banks have only recently become regulated. This is because cord blood storage is a fairly new area, therefore the usual authoritative bodies have not been as quick to established the appropriate regulations on the industry. For this reason, many banks have sought out accreditation from the American Association of Blood Banks (AABB).
What is the AABB?
An international association of blood banks, the AABB was founded in 1947 with the purpose of establishing a national standard in all matters related to blood banking. In fact, the AABB is the only organization in America whose only focus is blood banking. As a result, they have become the experts in the field and have set a high standard for organizations to meet. In order to be accredited by the AABB, an organization must be willing to continuously strive to provide the highest quality facilities, operating procedures, and care.
In 1991, the AABB published the Standards for Hematopoietic Progenitor Cells. In addition to outlining the appropriate methods of collecting, processing and transplanting marrow and peripheral blood, this guide also discussed the appropriate methods for handling cord blood progenitor cells. More recently, the AABB has been working to develop the Model Standards for Blood Banking, which would include ISO 9000 standards. As a result, this model could potentially serve as a universal prototype that blood banks around the world could conform to.
Why Don’t All Banks Have AABB Accreditation?
While researching the various cord blood banks, you have likely noticed that some banks clearly display a seal from the AABB on their website while others don’t mention anything about the AABB. This is because accreditation by the AABB is entirely voluntary. It is up to each cord blood bank to decide whether they would like to seek out accreditation or not. This does not necessarily mean that a bank without accreditation is inferior to a bank with accreditation. However, it may be a good idea to inquire about how these unaccredited banks will handle, process and store your stem cells.
How do Banks Get Accredited?
Since AABB accreditation is not mandatory, a cord blood bank will need to contact the AABB themselves and arrange for an AABB inspector to examine their facilities. After studying and scrutinizing a bank’s amenities, equipment and operating procedures, the AABB will make recommendations to bring the cord blood bank up to par with AABB standards. In order to achieve accreditation, a bank must make these changes.
Once a bank has been accredited, it will be necessary for them to maintain the standards set out by the AABB and be subject to routine inspections and upgrades. Not surprisingly, achieving and maintaining accreditation can be an expensive process, which is why many banks avoid it in the first place.
Is Accreditation Really That Important?
To some degree, accreditation is an indicator of the quality of a cord blood bank. Prior to 2005, the United States did not have any formal regulations on the books pertaining to how these types of blood banks should operate. If a bank was accredited, though, then consumers could be reassured that the bank they were dealing with held to high operating standards.
Since 2005, the Food and Drug Administration (FDA) has implemented regulations on the cord blood bank industry. This means that, in order to operate, all cord blood banks in the United States must adhere to these requirements, which ensure the safe handling and storage of cord blood stem cells. If an American cord blood bank also has AABB accreditation as well, then it is just further evidence of that banks commitment to quality.
The FDA
When the cord blood bank industry first began developing, the FDA did not play a large role in the business. Aside from establishing guidelines, which were not compulsory though most cord blood banks voluntarily followed them, the only regulation the FDA imposed was mandatory screening for certain disease, such as HIV.
As more people continued to bank their children’s cord blood stem cells, the FDA began increasing the number of regulations placed on cord blood banks. In January 2004, it became necessary for all cord blood banks, both public and private, to register with the FDA. This was done so the FDA could keep track of the companies and the stem cells more efficiently. Then in May 2004, all cord blood banks were required to screen both mother and baby’s blood for infectious diseases. This was not too big a change as most banks were already practicing this regulation.
A year later, in May 2005, the FDA finally set out a full body of regulations outlining the particular procedural methods that banks and laboratories must follow. These regulations cover the appropriate collection, processing, packaging, labelling and distribution of cord blood cells. Furthermore, it is now necessary for banks to alert the FDA if processed stem cells show an adverse reaction so that the FDA can inspect the stem cells. Though it may seem like cord blood banks are bound in red tape, all these steps and regulations help to ensure that your child’s stem cells are stored properly and will still be viable when you need them.
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