Suggested Questionnaire

This questionnaire is suggested for interviewing Private Cord Blood Banks. The questions are divided into different sections:

1. Collection of Cord Blood Sample
2. Shipping & Handling
3. Laboratory Testing & Accreditation
4. Processing
5. Storage Facility
6. Company Stability
7. Consumer Rights
8. Price protection

• What instructional tools are provided for the physician and delivery staff?

• What equipment is provided in the collection kit, and are there any spares?

• Will the cord blood company actively contact the labor and delivery staff for you -- or are parents responsible for keeping them informed and coordinated?
   
• Do they recommend collecting cord blood before or after delivery of the placenta? 
  
  Both methods can be used, and the volumes collected are comparable.  Most companies collect before delivery of the placenta.
   
• 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 adequate, but the syringe method yields a higher volume on average.  Both collection methods can be used with bag storage (next question), whereas vial storage requires syringe collection.
   
• What storage container do they use, multiple vials or a blood bag? 
  
  From a scientific perspective, vial and bag storage methods both have a long history of use and have yielded successful transplants.  However, from a regulatory perspective, the accrediting agency AABB is requiring all their accredited cord blood banks to adopt bag storage by 2007. 
   
• Do they provide the option of collecting additional stem cells from the placenta?
  

This is the latest wave in banking of umbilical and placental blood.  Research shows that the placenta also contains multi-potent stem cells which can be harvested after the placenta is delivered.  It is a separate procedure from the cord blood collection.  Only a couple of banks are offering this service to date (Oct 2006).

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• On weekends, are the laboratory staff in-house or on-call?

• Is the cost of shipping included in the contract? 
  

• If the bank provides shipping, do they offer bed-side pick-up?  Otherwise, the parents must designate some one to carry the cord blood to the shipping company.
   
• If the bank uses a courier, do they provide secure chain-of-custody handling? 
  
  "Secure chain-of-custody" means that a human being is physically responsible for the safety of the cord blood at all times. This is a stronger statement than claiming to know where it is on the basis of a computerized tracking system.  
  

The Parent's Guide to Cord Blood Foundation recommends shipping with a medical courier.
There's no point in spending a lot of money to bank your child's stem cells if they die in transport.  To maximize cell survival, umbilical cord blood should be kept at room temperature. It should not get hot in the back of a truck or on a loading dock, and it definitely should not fly in the cargo portion of a plane where it can freeze.  A quick review of the main shipping options:

• FedEx is the most well known shipping company in the USA.  Beware that Fedex can NOT guarantee the temperature stability of cord blood.  Fedex is not in the medical transport business; they only guarantee that it is there on time or its free.
• DHL is the most well known shipping company in other parts of the world.
  

There are two medical couriers in the USA who commonly ship cord blood:

• AirNet Express (NYSE: ANS) is a courier with a medical division that routinely 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) airplanes, and they guarantee the temperature stability of medical shipments. Because they own their planes, the cord blood is always under 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.
   
• QuickSTAT is an autonomous division of Quick International, an international courier whose medical division is 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 note 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).
  
  Some cord blood banks have courier contracts with Quick included in their price.   Parents seeking a direct contract with Quick have to be careful 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.
  

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• Will they notify the parents of the time at which the cord blood arrived, and the time at which it was processed?
   
• What tests are performed on maternal blood?
   
• Do they ever reject samples on the basis of maternal tests?
   
• Do they test the cord blood collection for infectious disease markers?
   
• Do they test the cord blood collection for contamination by bacteria, etc.?
   
• Do they ever reject cord blood collections that are contaminated?
   
• Will they notify parents of the test results, especially the final cell count?
   
• 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 at a bulk price. 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?
   
  
• By which organizations are they accredited?
  
  This website has a separate page explaining cord blood laboratory accreditations. Very briefly, the primary accreditation standard used by private/family 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".
  

Medical Requirements:
The screening criteria which are medically recommended for blood products vary with the product and its intended use:  All blood donors are required to pass a series of medical history questions to prove that they are eligible to donate (FDA guidelines as of 23April2004). The health history for bone marrow donors covers all the criteria for blood donors, plus some extra concerns. The eligibility guidelines for (mothers) donating umbilical cord blood are less restrictive, because the mother and baby do not share the same blood supply, although some transmission of antibodies does occur across the placenta. If the mother donates the cord blood to a public bank, then the baby's blood will be screened for infectious disease markers.

Companies which provide private/family banking of cord blood vary in their adherence to standard blood donor criteria; certain risks might be acceptable in a family setting.  However, those companies which are accredited by AABB or FACT must adhere to specific screening requirements and must reject those collections which fail them.

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, and there was no regulation at all for private/family cord blood banks.  This was a source of much criticism, too plentiful to review.   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  (see the page on laboratory accreditations for more detail).

Accreditation:
The only two standards of accreditation which are specific to cord blood banking are AABB and FACT.  They are explained in a separate web page on cord blood laboratory accreditations.   Several other forms of accreditation or licensure are also described. 

Parents, if your child's cord blood is ever used, the end consumer 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. 

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Some companies 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).  A description of cord blood processing is provided on a separate page.

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

• What processing method do they use?

• How many small testing portions are stored with the blood?  The testing portions can be removed, thawed, and tested if the blood is being considered for transplant.
  

• Is the blood stored as a single unit or in compartments ?
  
  The advantage of storing in compartments is that the collection can be used a portion at a time.  For transplant purposes, it is desirable to have as many stem cells as possible, so the whole unit would be used whether or not it was divided into portions.  However, if future therapies are developed which only require a small number of seed cells, then compartmented storage would be desirable.
   
• 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.  The minimum dose is no longer an absolute requirement, because adults can be transplanted by expanding the cell count in the laboratory or by combining multiple cord blood units (see the page about research on cord blood transplants).  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.
  

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• Do they operate their own storage facility or lease space in one? AND In what type of facility is the bank located?
  
  If the cord blood bank sub-contracts the services of a regular blood bank, you know for sure that all the operating procedures are subjected to the high level of regulation required of blood banks. On the other hand, if the cord blood bank owns their own laboratory, it can mean several things: 
  1) It could mean that they have a high enough volume of business that they can afford to maintain a private medical lab devoted to cord blood. 2) It could mean that they are a successful business in another branch of medicine which can afford to devote a department to cord blood banking. 3) It could mean that their lab is not as regulated as a blood bank.
  
  Typically the questions listed above about the laboratory accreditation will cover any concerns about the storage facility, unless the cord blood is stored in a separate location from where it was processed.
   
• What is the geographic location of the storage facility? 
  
  The collected blood will travel directly to the processing lab. The lab may not be next to the office that takes phone calls. The longer it takes the blood to get to the lab, more cells will die.  If you are choosing between comparable banks, it makes sense to select the one whose storage location is closer to you, so that the blood has a shorter distance to travel.
   
• Are the cord blood samples in a separate freezer or mixed with other medical samples? 
  
  This can determine how often the freezer is opened; it is preferable to store cord blood separately.
   
• What type of freezer do they use? 
  
  Typically cord blood is stored in large "dewars", which are insulated tanks with lids.  The only variation among these freezers is whether they have automated mechanisms to retrieve a unit for removal.
   
• Do they freeze in liquid nitrogen or vapor nitrogen?
  
  The trade-off here is that: liquid nitrogen is less susceptible to temperature fluctuations, but vapor nitrogen ensures no transmission of disease from the surface of one container to another.
   
• What type of records do parents receive after storage?
   
• Does the contract state that the storage fee is fixed, or may it increase later?
   
• Does the bank reserve the right, in the contract, to change storage facilities?

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• Is the family cord blood bank a publicly-held or privately-held company? 
   
• Is the company affiliated with a hospital or research institution? 
   
• Is the company involved in bio-technology research and development?
   
• What other medical services does the company perform?
   
• How long has the company been banking cord blood?  Notice this is not the same as the age of the company.
   
• Who directs the day-to-day business of the company? 
   
  Many cord blood banks have famous doctors on their Board of Directors; but those doctors have nothing to do with the day-to-day operations.
   
• How many privately banked cord blood samples do they hold? 
   
• How many transplants have been performed with their cord blood samples?

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Please READ THE CONTRACT before choosing a company. 

• In the event that the storage company went bankrupt, what would happen to the cord blood samples?
  
  Examples: One of the earliest cord blood banks was Biocyte, founded by the well-known stem cell researcher Hal Broxmeyer, PhD. Unfortunately, they went out of business. Their samples were stored at the Central Blood Bank of Pittsburgh, and that facility agreed to maintain their storage. Since then, Dr. Broxmeyer has served on the Advisory Board of ViaCord. By comparison, when LifeBlood Cryogenics went bankrupt, parents lost their banked cord blood.
  
  In 2001, a company named Bio-Cell opened up in Coral Springs FL. They were actually shipping cord blood to the laboratory of Cryo-Cell in Clearwater FL, but were charging parents twice as much as Cryo-Cell. They went out of business in less than a year, but parents were able to locate their cord blood in the Cryo-Cell storage facility.
  
  In 2002, a company named American Cord Blood Institute opened up in The Woodlands, Texas. They tried to enter the high end of the market, running a very high quality operation; but they could not find enough customers willing to pay their prices and went out of business in less than a year.
  
  In 2003, BirthCells Technology of Eatontown, NJ, closed shop after four years of operations. They were also using the laboratory of Cryo-Cell International in Clearwater, FL. It is possible that they could not maintain a profit margin after Cryo-Cell substantially increased their prices in spring of 2003. Again, storage contracts will be maintained by Cryo-Cell.
   
• If the cord blood is lost or severely delayed during shipping, what liability does the company accept?
   
• If the storage fee is not paid, what happens to the cord blood?
   
• Does the company take ANY portion of the cord blood for proprietary purposes, or does 100% go into storage?
   
• Does the storage company reserve any rights in the contract?
  
  Example: reserves the right to change the storage facility.
   
• Does the contract protect the privacy of the parents' health information, as stipulated by The Health Insurance Portability & Accountability Act (HIPAA regulations)?
  
  This site has a page devoted to privacy issues.

Please note, if you have a serious problem with your cord blood banking experience, which results in the cord blood being lost or severely damaged (for example a long shipping delay would render the stem cells non-viable), then an attorney who specializes in cord blood damage claims is Kenneth Morris (415-453-9433)

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• Is the enrollment fee charged once per family, or for each birth? 
   
• At what week of gestation are late enrollment fees imposed, and how much are they?  
   
• How do they charge for cord blood samples from multiple births?
   
• If the cord blood collection is small or contaminated, are parents offered any refunds? 
   
• Is the storage fee guaranteed fixed?

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For those readers who really thrive on nitty gritty detail, you can download the Cord Blood Bank Standard Operating procedures that are required by the COrd BLood Transplantation study (COBLT). Caveat: Bear in mind that COBLT is an NIH study conducted at medical research centers in which mothers donate their baby's cord blood anonymously. Their guidelines are not binding on private cord blood banks! However, skimming through this material is very educational.