Questions Parents Should Ask Family Cord Blood Banks

Topics covered:

1. Company Experience
2. Cord Blood Collection & Shipping
3. Laboratory Standards
4. Storage Facility
5. Therapeutic Applications
6. Tissue Banking
7. Price Plans

These questions are designed to be general so that they can be asked in any country. The Parent’s Guide to Cord Blood has been developing questionnaires for parents since 1998. Over the past 25 years, the procedures at family cord blood banks have become more standardized, so there is less need to ask questions that weed out irresponsible practices. However, parents should not slip into the mistake of treating cord blood banking as a commodity, thinking that everyone offers the same service and only the price varies between providers. There are still quality differences from one bank to another, there are still significant differences in the terms of bank contracts, and these questions will help parents to discriminate between banks.

 
Questions parents should ask about a family cord blood bank’s experience.

• How many years has your service provider been banking cord blood?
• Is your local cord blood bank owned by a parent company? Do they invest in research on cord blood therapies?
• If your bank brags about having a relationship with a famous doctor or scientist, ask if that person actually directs their day-to-day activities.
• How many babies have stored cord blood in the bank? Make sure they are quoting “clients served”, and not “samples banked”, which can be a much bigger number if they count each storage compartment of cord blood and cord tissue.
• How many cord blood collections has your bank released for therapy? Knowing that their laboratory has released therapies is proof that they can take cord blood full circle from collection, through storage, to clinical application.
• Is the cord blood service provider that you are considering a full-fledged bank with a laboratory, or do they ship your cord blood to a laboratory located elsewhere? How far away is the actual laboratory; is the laboratory in a different country? This will determine how long it takes to ship your baby’s cord blood to the laboratory. 

 
Questions parents should ask about a family cord blood bank’s collection & shipping.

• What instructional tools are provided in the collection kit for the person who delivers the baby?
• Is the blood collection bag sterile, both inside and out, so that it can be used in the operating room for a C-section?
• When the cord blood is picked up from the hospital, is it carried by a medical courier that is responsible for the cord blood throughout transit?
• Some regulations require that cord blood be processed within 48 hours of collection. Does your bank guarantee to get the cord blood to the laboratory and processed within a certain time window?
• What type of insulation does your collection kit have to maintain the temperature stability of the cord blood during shipment to the laboratory?
• Does your bank provide a temperature logger to continuously track the temperature inside the kit during shipment? This is very common worldwide but rare in the US, despite the size of the country and the variations in climate zones.

 
Questions parents should ask about a family cord blood bank’s laboratory standards.

• Is the cord blood laboratory licensed with their national authorities? In the US this would be the FDA; in many other countries it is the Ministry of Health.
• Does the cord blood laboratory have accreditation from an international organization that sets standards specifically for cord blood banking and conducts inspections? The two options are AABB or FACT. Our website provides a look up by country of accredited banks.
• Some countries require cord blood banks to follow standards that are similar to the AABB and FACT accreditations. These include Australia’s TGA, Switzerland’s Swissmedic, and the UK’s HTA. In these countries it is not necessary for banks to seek AABB or FACT accreditation because the national regulations cover them.
• If you live in one of the US states that license cord blood banks (CA, IL, MD, NJ, NY) then you can only use a family bank that is licensed to operate in your state.
• Does your bank’s laboratory process cord blood collections 24/7?
• What processing method does your bank use to separate stem cells from the cord blood? It is not advisable to store whole blood. Be wary of claims that one processing method is vastly better than the others.
• What tests does the laboratory perform to measure the cell count of the processed cord blood? Does your contract promise that the bank will inform you if the cell count is low?
• What tests does the laboratory perform for cord blood contamination? Does your contract promise that the bank will inform you if the contamination test is positive? Will you receive a refund if you decide not to continue with storage?
• Does the laboratory maintain a "quarantine tank" for the storage of cord blood stem cells while they are waiting on the results of testing for infectious disease markers and contamination? Cord blood units which test positive can be placed in long term storage, but they should be kept in a separate tank from cord blood units that passed all testing.

 
Questions parents should ask about a family cord blood bank’s storage facility.

• What is the geographic location of the storage facility: How high is the risk for hurricanes, earthquakes, or other natural disasters?
• Cord blood banks should have multiple layers of security to protect their storage tanks. Ask your bank how their laboratory monitors the temperatures in their storage tanks and how swiftly their staff can react to an alarm at night or during a holiday.
• What type of back-up systems does the storage facility have?
• Does your bank reserve the right, in the contract, to change storage facilities? How and when will you be notified?
• Does your bank offer the option to store cord blood in a multi-compartment freezer bag, so that you potentially can use it for therapy more than once?

 
Questions parents should ask about a family cord blood bank’s therapeutic applications.

• Does your bank allow parents to retrieve their cord blood for any purpose? In the US, some banks will not allow parents to retrieve their cord blood unless they are participating in an FDA-approved treatment program.
• Does your bank provide free cord blood banking to help families that have a sibling in need of a stem cell transplant?
• Does your bank have an inventory of public donations or a community pool that can be searched to provide additional sources of cord blood therapy for your child?
• Does your bank have an insurance program to compensate clients, if they need the cord blood for therapy and it is somehow defective?
• In the event that your child needs a stem cell transplant, does your bank provide a payment to help defray the cost of therapy? This is not common in countries with good or universal health insurance, but it is common in countries where the costs of stem cell transplants are not adequately covered by health insurance.

 
Questions parents should ask about a family cord blood bank’s tissue banking.

• Does your bank store little pieces of whole tissue from the umbilical cord and/or placenta, or do they first isolate Mesenchymal Stem/Stromal Cells (MSC) and then freeze the cells? Most cord blood banks only store pieces of tissue. The biggest motivation for not extracting cells from the tissue is because it costs the bank less to skip tissue processing. Moreover, in some countries there are regulatory concerns about getting approval to use isolated cells for therapy.
• If the bank stores little pieces of whole tissue, have they published a validation study proving that they can retrieve cells from these pieces after they are thawed?
• If the bank stores isolated MSC from umbilical cord and/or placenta tissue, do they culture the cells to expand their numbers before storage?
• Is the bank accredited by AABB for the “somatic cell” activity of processing tissue to isolate MSC?

 
Questions parents should ask about a family cord blood bank’s prices.

• Are there any discounts currently available? Most banks are constantly running a "limited time" discount of some form.
• Does your contract include a certain number of years of storage, or will you pay an annual storage fee?
• Does your contract promise that the annual storage fee is fixed, and if so for how long?
• Should the family ever need the cord blood, will the bank charge to ship it to a hospital? If the bank says there is no charge to release the cord blood for an approved therapy, what is included on the list of approved therapies?