SUGGESTED QUESTIONNAIRE
for interviewing Private Cord Blood Banks in Germany

In the USA, it is possible to download the Cord Blood Bank Standard Operating procedures that are required by the COrd BLood Transplantation study (COBLT) . COBLT is a study funded by the USA National Institute of Health (NIH). The COBLT standards apply to participating medical research centers where mothers donate their baby's cord blood anonymously. Their guidelines are not binding on private cord blood banks! However, skimming through this detailed material is very educational.

In Germany, the German Drug Law (Arzneimittelgesetz) and the Cord Blood Guideline (Richtlinien zur Transplantation von Stammzellen aus Nabelschnurblut) of the Federal Medical Association (Bundesärztekammer) imposes requirements on ALL cord blood banks, BOTH public and private, which process and store samples INSIDE Germany. These regulations require all German cord blood banks to operate under GMP-conditions and with Standard Operating Procedures. Otherwise they will not receive the necessary manufacturing authorization (Herstellungserlaubnis). Similar standards are requested in AUSTRIA.

Will the company proactively contact the delivery hospital for you
(or are parents responsible for keeping them informed and coordinated)?
Do they collect cord blood before or after delivery of the placenta?
Both methods are routinely used, and the volumes collected are comparable.
What collection method o 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, though the syringe method yields a higher volume on average. But there is a higher risk of contamination if the cord must be punctured repeatedly.
What storage container do they use, vials or a bag?
Both methods are routinely used. Bags can be used in conjunction with any collection method; vials are used in conjunction with syringe collection.
What equipment is provided in the kit for the physician?
A disinfection accessories kit eases the disinfection and can improve the quality. Forms that must be completed are necessary for the security and the quality control.
What instruction tools are provided for the physician?

Is shipping included in the price?
If the bank uses a courier, do they provide secure chain-of-custody handling?
"Secure chain-of-custody" means that somebody 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.

In Germany, the cord blood bank normally organizes shipping. Thus, the parent must rely on the bank's choice of courier.
On weekends, are the laboratory staff in-house or on-call?
How long does shipping take and how is the cord blood stored during transport?
The Cord Blood-Guidelines state: "The collected CB (Cord Blood) must be stored and shipped appropriately at room temperature (22 degree C ± 4 degree C). Shipping to the processing facility should be done within 24 hours." These conditions are designed to keep a maximum cell count alive.

Medical Requirements:
All blood donors are required to pass a medical history questionnaire. 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. Moreover, in a public donation setting, any donated blood or blood product is routinely screened for infectious disease markers.

Companies which provide private banking of cord blood vary in their adherence to the standard blood donor criteria; certain risks might be acceptable in a family setting.

Legal Requirements:
In Germany, the Federal Medical Association (Bundesärztekammer) has issued Cord Blood-Guidelines (Richtlinien für die Transplantation von Stammzellen aus dem Nabelschnurblut) that are binding for both public and private banking in Germany. These guidelines regulate which testing must be done in Germany. A company's compliance with the Cord Blood-Guidelines is supervised by the responsible regional councils in collaboration with the Paul-Ehrlich-Institute. These guidelines are NOT binding for private companies that store the cord blood outside Germany. That means, that companies which ship the cord blood out of Germany for storage are NOT suprevised by German inspectors and may not be up to German standards.

Accreditation:
In Germany every cord blood bank needs a manufacturing authorization in accordance with the German Drug Law. The issue of this authorization requires "Standard Operating Procedures" for all steps in cord blood banking, including laboratory testing. That means that their work must be GMP-compliant. The accreditation process is costly and cumbersome, and some banks may choose to forgo it or to set up abroad. However, the manufacturing authorization is the only guarantee a parent can have about the operating procedures at the bank.

Bear in mind that the end consumer of cord blood, if any, will be a transplant physician. That physician is very unlikely to use a sample which is contaminated, regardless of what reassurances the bank issues.

Here you find an overview of all quality tests which are required in Germany by the Cord Blood-Guidelines and the federal authorities. These requirements are binding for all public and private banks that store cord blood in Germany.

Common tests of the cord blood

test	comment
NC-count	nuclear cell count (white blood cells) without erythroblasts (erythrocyte progenitor cells without nucleus).
TNC-count	overall nuclear cell count including erythroblasts
Blood picture	Measuring the count of different blood cells: white blood cells (WBC), red blood cells (RBC), Hemoglobin (Hb), Hematokrit (Hk) and platelets (PLT).
Aerob/anaerob blood culture	Sterile testing. Testing whether germs (bacteria, fungus) got into the cord blood during the collection.

Serological tests of cord blood and maternal blood

test	comment
HBV	Hepatitis-B-Virus
HCV	Hepatitis-C-Virus
CMV	Cytomegalie-Virus
Parvo-Virus B19	ParvoB19-Virus (fifth disease virus)
HIV 1/2	Test on HIV-Virus antibodies
TP-Ak	Test on syphilis antibodies (Treponema-pallidum-Virus)
ALAT	Activity of the hepatic enzyme Alaninaminotransferase (former GPT)

Will they notify the parents of the time at whcih 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 sample for infectious disease markers
What other contamination tests are performed on the cord blood sample?
Do they ever reject samples that are contaminated?
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?
Will they notify parents of the test results?
Do they HLA type the sample?
HLA typing is required to match a patient and donor prior to transplant, but costs about 400-500 Euro. 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.
Has the company obtained a manufacturing authorization in accordance with the German Drug Law (Arzneimittelgesetz?)

The Pros & Cons of processing out mononuclear cells are discussed on a separate page.
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?
It used to be argued that storing smaller samples was useless, because they did not meet the recommended dose for transplant. However, we now have technology to expand the cell count in the laboratory prior to transplant, and this has been used successfully in clinical trials on adults.
Is the blood stored as a single unit or several samples?
There are 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 whole sample.
2. The sample can be used in portions, if by that time the technology for stem cell expansion is mature and routine.

Do they operate their own storage facility or lease space in one?
AND In what type of facility is the bank located?
A private cord blood bank that stores cord blood in Germany needs a manufacturing authorization in accordance with the German Drug Law (Arzneimittelgesetz). That means, the bank must have GMP-compliant facilities. If a bank stores the cord blood abroad you should ask about the the national requirements. Does the bank need GMP-compliant facilities?
You should be sure that you are comfortable with the storage environment, by asking explicit questions and demanding direct answers, even photos of the facility.

What is the geographic location of the storage facility?
The collected blood will travel directly to the processing lab. Usually it is not next to the office that takes phone calls. 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?
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?

Company Stability

Is the company public or private?
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?

Please READ THE CONTRACT before choosing a company.
Some interesting revelations from readers comparing contracts are posted in the "notable comments" section of the feedback page .

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, Ohio, USA, 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, Florida, USA. They were actually shipping cord blood to the lab of Cryo-Cell in Clearwater, Florida, 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, USA. 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.

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?

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Copyright 2000, 2001, 2002, 2003, Frances Verter