To ensure the quality of the cord blood collection, each collection site has National Cord Blood Program-trained staff.

Cord blood units for the New York Blood Center's National Cord Blood Program are currently collected at six collaborating hospitals. These hospitals were selected because they have large Obstetric Departments serving ethnically diverse populations. Each hospital site has a team of NCBP-trained cord blood technicians and nurses working with the hospital's Obstetricians, Obstetric service nurses and other staff. The NCBP team is responsible for collecting the cord blood and for obtaining the mother's Informed Consent, a blood sample from the mother, a saliva sample from the baby and the mother's and baby's medical and family histories.

Cord blood can be donated only if the mother and infant are eligible. Cord blood CANNOT be collected when:

1. The mother had an infectious disease during pregnancy that could have been transmitted to the infant before or during birth and might be present in the cord blood, or
2. The infant has one of several genetic or inherited diseases that might affect a patient if the cord blood was given as a transplant, or
3. There is a family history of a "transplantable" genetic disease that might be present in the baby, but for which there are currently no diagnostic tests., or
4. The pregnancy was the result of an egg (ovum) donation, or
5. The family has arranged to store the cord blood with a private cord blood bank.

NCBP-trained technicians collect cord blood from the delivered placenta.

After the baby is born, the umbilical cord is clamped and cut and the placenta is delivered. The Obstetrician or midwife places the placenta in a sterile container and passes it on to an NCBP technician. The technician takes the placenta to an adjacent, specially-equipped laboratory. She cleans the surface of the umbilical cord attached to the placenta. To collect the cord blood remaining in the umbilical vein and placenta, the technician uses a sterile blood collection bag set with attached tubing and needle and punctures the cleaned surface of the cord with the needle to enter the umbilical vein. The cord blood drains through the tubing into the bag by gravity. Because we collect cord blood after the placenta is delivered and outside of the delivery room, collection does not interfere in any way with the care given to the mother and infant. The procedure is risk-free for mother and baby.

Cord blood can be DONATED only if enough cells were collected.

Cord blood transplants are most successful when the patient receives a relatively large number of stem cells. The number of stem cells in cord blood is related to the volume of blood that can be collected and to the concentration of the nucleated blood cells present. To optimize the usefulness of the cord blood units in our inventory, we now require a minimum of 900,000 nucleated cells for a cord blood unit to be donated for transplantation. This is the number of cells found in about 80-100 milliliters (about three ounces) or more of cord blood on average. We can obtain a collection with an adequate number of cells from about 40% of deliveries.

The cord blood unit is given a unique ID number.

When the mother and infant are eligible to donate and the unit has enough cells, a unique identification (ID) number is assigned, using a pre-printed bar-coded label. Data forms and all other specimen tubes get the same ID number, all bar-coded and human-readable. To prevent mix-ups when several babies are delivered at the same time, NCBP staff attempt a new cord blood collection only after the previous collection and all its paperwork and tubes are completely labeled and identified (NCBP's “one-at-a-time” rule). This is one of the reasons why we cannot collect cord blood from all deliveries.

Mother's consent is requested.

As required by the NCBP's FDA IND exemption, the mother is asked to consent to donate the cord blood to the NYBC's National Cord Blood Program for any patient who might need it in the future. If the mother does not want to donate or is not eligible to donate, the cord blood is discarded.

Interview and medical record review.

When the mother consents to donate, NCBP-trained staff obtain information from her own and her baby's medical records. Staff also ask her questions about her past medical history, about this pregnancy, and about her ethnic background and family history of genetic diseases and that of the baby's father. We ask about risks for certain infectious diseases that can be transmitted by blood or from mother to infant. All of this information helps the NCBP characterize the cord blood and assess possible risks of transmission of an infectious or genetic diseases to a patient who might be given the cord blood sometime in the future as part of a clinical research study.

A blood sample is taken from the mother.

A sample of the mother's blood is needed to test for infectious diseases that can be transmitted by blood or across the placenta to the baby. The mother's blood is also tested for her HLA type to make sure no mistake was made in taking the blood sample.

A sample of saliva (for Cytomegalovirus testing) is taken from the baby by wiping a sterile Q-tip around the baby's gums.

About 2/1000 to 2/100 babies in the U.S. will be born with a Cytomegalovirus (CMV) infection. CMV can cause hearing loss and, rarely, causes retardation if the infection occurs early in pregnancy. Fortunately, most babies with CMV are perfectly healthy. A baby that is infected with CMV sheds the virus in urine and saliva, where it can easily be detected. Even though CMV is not very common in newborn babies, we test the baby's saliva because CMV can cause a severe, even fatal, infection in a transplant patient if it is present in the cord blood unit.

The cord blood and mother's blood will be tested for certain infectious diseases.

The mother's blood and cord blood samples are tested for infections with hepatitis type B and C viruses (HBV and HCV), human immune deficiency virus (HIV, the AIDS virus), human lymphotropic virus (HTLV) and syphilis. The same tests are used routinely to screen regular volunteer blood donors. The tests are done free of charge and results are sent to the mother's Obstetrician and the baby's Pediatrician.

The cord blood will be tested for certain genetic diseases.

The cord blood is tested for the common defects in hemoglobin (the oxygen carrying molecule in red blood cells), including sickle cell anemia.

Samples are saved and may have further testing in the future.

Confidentiality.

All cord blood units, the mother's written consent and completed data forms are sent to the NYBC's National Cord Blood Program for processing and data entry. To protect donor confidentiality, consent and data forms are kept in a locked file room, available only to authorized Program staff. Data is also entered into a secure computer with no electronic link outside of the NYBC.

Qualification of Cord Blood Units for the NYBC's National Cord Blood Program Inventory.

A cord blood unit must meet all of the criteria (at a minimum) below to qualify for inclusion in the NCBP Inventory and available for transplantation:

1. The unit contains 900 million or more total nucleated cells (TNC) before processing. Note: units collected in the first few years of the Program may have had fewer TNC;

2. The unit has been typed for HLA-A, -B and -DRB1 (A and B at low resolution and DRB1 at high resolution);

3. The mother's HLA type is compatible with that of the cord blood unit;

4. A sample of cord blood is available in tubing attached to the cord blood unit for confirmatory HLA typing;

5. The infant has no identified genetic disease that might be transmitted in the cord blood;

6. The unit and the mother's blood are negative for infectious disease markers, including HBsAg and antibodies to HCV, HIV and HTLV;

7. There are no significant risks for blood transmissible infectious diseases;

8. The cord blood unit was processed and frozen following the NCBP protocol validated to maintain nucleated cell viability.