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Choosing A Private Cord Blood Bank

By: Greg Roy

Here are some questions to as when you are searching for a private cord blood bank.

1. Collection of the Cord Blood Sample.
Will the company proactively contact the labor and delivery staff on your behalf, or are you responsible for keeping the delivery staff informed and coordinated?

Do they collect the cord blood before or after delivery of the placenta?

Both methods are routinely used, and the volumes collected are approximately the same.
What type of storage container do they use, vials or a bag?

Bags can be used in conjunction with any collection method; vials are used in conjunction with syringe collection. Both methods are routinely used.

What collection method do they use?

The commonly used methods are: letting the blood drip out by gravity versus pulling it out with a syringe. Both collection methods are fine, though the syringe method yields a higher volume on average.

What equipment is provided in the kit for the physician, and are there any spares?
While physicians do have access to all the necessary tools, the easier the cord blood bank makes it for them, the smoother the process will go.

2. Shipping & Handling.

Is the cost of shipping included in the contract?

If the bank uses a courier, do they provide secure chain-of-custody handling?

"Secure chain-of-custody" means that a designated person is physically responsible for the safety of the cord blood at all times. This is a much stronger statement than simply claiming to know where it is on the basis of a computerized tracking system.

Shipping with a medical courier is highly recommended. There's no point in spending a significant amount of money to save your child's stem cells if they die in transport.

Federal Express is the default shipper recommended by many private cord blood banks in the USA. Remember that the parents must designate somebody to promptly transport the cord blood sample from the hospital to Federal Express.

However, Federal Express DOES NOT guarantee the temperature stability of the shipment in transport. Umbilical cord blood should be kept at room temperature. It should not be allowed get hot in the back of a delivery truck. Nor should it fly in the cargo portion of a plane where freezing can happen. Remember, Federal Express is not in the medical transport business; their guarantee is that it is delivered on time or its free. Temperature is not addressed by them. It is your responsibility to inquire if you choose to ship via Federal Express.

A much more desirable method of shipping is through a medical courier, as temperature during shipment will be addressed. There are two medical couriers in the USA who routinely ship cord blood: AirNet Express (NYSE: ANS) is a courier with a medical division that regularly transports blood and tissues for donation or cryogenic storage. Their couriers are available at all times to pick up your cord blood sample from the hospital and hand carry it to the airport. Airnet is the only courier which flies cord blood on its own fleet of over 100 planes, and they guarantee the temperature stability of medical shipments. As such, the cord blood is always within their custody.

Some cord blood banks have courier contracts with AirNet included in their price. Parents seeking a direct contract should contact medical_services@airnet.com or phone 1-888-888-TIME.

The other medical courier is QuickSTAT, an autonomous division of Quick International, an international courier whose medical division was for many years the leading shipper of cord blood and organs for transplant. Their couriers are available at all times to pick up your cord blood sample from the hospital and hand carry it to the nearest major airport. Quick shipments fly on commercial airlines, but they guarantee the temperature stability of medical shipments. Please be aware that, while the cord blood is on the commercial airplane, there is no one individual responsible for holding it (ie: not a secure chain-of-custody).

Parents seeking a direct contract with Quick have to ensure contact the correct division. The company is divided into regional divisions where the people answering the phone frequently are not knowledgeable about cord blood shipment. It is essential to contact the medical division of QuickSTAT, not just the nearest office of Quick International. The North American business center of QuickSTAT is statwebsales@qintl.com or phone 1-800-856-STAT.

3. Laboratory Testing & Accreditation.

Here are some questions to ask regarding the testing of the sample and the accreditation of the lab doing the testing:

What tests are performed on maternal blood?

Do they test the cord blood sample for infectious disease markers?

Do they ever reject samples on the basis of maternal tests?

Are there any other contamination tests performed on the cord blood sample?

How often do they reject samples that are contaminated?

Will they notify parents of the test results?

Do they maintain a separate "quarantine tank" for the long-term storage of blood that has failed one or more tests, or is the blood stored together regardless of testing status?

Do they HLA type the sample?

HLA typing is required to match a patient and donor prior to transplant, but costs about $200. In public cord blood registries, all samples must be HLA typed. In private banking, there is no compelling reason to HLA type a sample until/unless it is needed for transplant.

Some states license cord blood banks (NJ, NY): Do they operate in those states, and do they have the required license?

By which organizations are they accredited?

Very briefly, the primary accreditation standard used by private cord blood banks is AABB. The AABB maintains on-line lists of facilities which have been inspected and accredited as AABB cord blood banks or AABB Hematopoietic Progenitor Cell (HPC) laboratories. Please note that being a "member" of the AABB is not the same as undergoing inspection and being "accredited".

Legal Requirements:

In the early years of cord blood banking (the mid-1990's), the FDA only regulated public cord blood banks, where the blood would be given to an unrelated patient. There was no regulation at all for private/family cord blood banks. As of May 2005, the FDA has implemented a "Tissue Action Plan" which regulates private cord blood banks, and the FDA has started holding surprise inspections of laboratories.
One final comment about accreditation:
Parents, if your child's cord blood is ever used, the end user will be a medical doctor. That doctor will be much more comfortable accepting a cryogenic specimen that was stored in a facility holding medical accreditations. This is especially true if the cord blood is needed for a transplant.

4. Processing.

Some banks freeze the cord blood whole, while others process the sample to remove red cells and/or plasma, leaving behind mononuclear cells (MNC) which include stem cells (only 1-2% of MNC are stem cells).

All the public registries separate MNC for storage. A few years ago the private banks were mixed in this practice; now they are all moving to adopt separation procedures.

Is the blood stored whole or processed to separate mononuclear cells (MNC)?

What is the minimum volume they will accept for storage?

Public banks usually impose a minimum volume requirement, based on the assumption that a single collection has to be enough to supply the recommended dose for a transplant. This assumption is no longer valid, as adults can be transplanted by expanding the cell count in the laboratory or by combining multiple cord blood units. There is no minimum volume requirement developed yet for regenerative medicine applications. Private banks do not impose minimum volume requirements, but some will advise parents if the cell count is low and ask if they wish to save the collection.

Is the blood stored as a single unit or several samples?

There are two important advantages to freezing in portions: 1) It is essential to have a small testing portion called an "aliquot", so that the blood can be tested for potential transplant without defrosting the entire sample. 2) The sample can be used in portions.

Article Source: http://www.thehealthmanual.com

Greg Roy has come to understand the benefits of Cord Blood Banking through personal experience. Medical researchers believe that stem cells have the potential to change the face of human disease. Find out how you can provide a medical safety net for your children at cord-bloodbanking.com.


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