Thursday, July 24, 2008

Cord Blood Bank Guidelines and Cost

The cord blood bank guidelines and legal issues vary with the country. For the Americans, it is important to know about the AABB and the meaning of the accreditation and the FDA guidelines. At present, there is not much regulation imposed by the FDA in the field of cord-blood preservation, except that of compulsory screening for diseases like HIV.

In the year 2000, the FDA had tried to tighten their regulatory hand over this industry, but it received a severe protest from various groups, particularly the private banks. This was because it required a lot of financial investment by the banks to comply with the regulatory laws.

However, by January 2004, all the banks dealing with storage were mandated to register with the FDA. This allows the FDA to keep a watch over the companies and the blood that is been stored.

From May 2005, all the banks were required to fulfill new federal safety standards set up the FDA. The Cord blood Registry (CBR), which is the country's topmost registries, has been devising these standards since 1997 and it will establish the baseline standard for all the banks. These regulations set up the legal foundation and provide validation to the significance of the storage.

The FDA rules, which were proposed the first time in 1997, call for the banks to implement techniques to ward off contamination during collection, labeling, processing, storage, and distribution part of their service. The present industry oversight, which is the only one of its kind, is provided by the AABB (once the American Association of Blood Banks). The AABB had set up voluntary accreditation guidelines for banks.

The Meaning Of AABB Accreditation

Possessing the AABB accreditation means the bank is recognized for the specialized processing step of hematopoietic stem cells. It means that the lab as well as administrative processes of the bank are monitored and validated, and are found to fulfill the standards set up by AABB. GENERAL ACCREDITATION IS NOT ENOUGH. IF A BANK IS NOT ACCREDITED, REJECT IT.

Another issue is that of "autologous" and "family" use. As per the FDA guidelines, the bank has to carry out certain tests before storing your baby's placenta to allow its use for other family members. If your bank does not carry out this test, then your cord-blood sample is stored "autologously", which means that the sample can be used ONLY for the baby from whom it was collected and NOT for other siblings or family members.

Finally, it is essential that your baby's blood is saved in a bank that boasts of an appreciable history and its samples are used frequently for successful transplant operations. It is important that the bank practices ethics, has a license, complies with all the required regulations, and maintains the certificates of accreditation. Although the FDA has no regulation over private banks, they DO impose regulations over blood banking as a whole.

Banking Costs

There are two kinds of fees related with cord-blood banking. The first kind is the initial fee. It includes enrollment charges, collection, and storage for a minimum of one year. For the second year, you need to pay an annual banking or storage fee. Some banks provide choices for the initial fee combined with preplanned extended time of storage. The fee can be anything between $900 and $1500 depending on how much the time is extended. The annual fee is around $100.

Although you may feel it to be an expensive affair, the cost of processing and storage in medical freezers for many years is really quite significant. Even the public banks have to invest around $1,000 unit. Commonly, the banks offer discounts at prepaid plans and payment plans to ease out the process of initial storage for you.

However, THERE IS NO COST INVOLVED IN CORD-BLOOD DONATION. The donor banks, especially the non-profit ones, take care of the cost factor for saving the cord blood. However, if you wish to store blood for your own family use, then you have to pay a certain fee. Consult your doctor for knowing more about the fees involved.

Overseas Cord blood Unit

If you wish to get an overseas unit of cord blood, the cost may be a whopping $30,000. It may cost you around $700 for collection, processing, and storage in Australia, and about $16,000 to get a suitable sample from the ACBB to be used in transplant. HOWEVER, IT IS RECOMMENDED TO AVOID OBTAINING OVERSEAS UNITS.

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