Human Tissue Authority

The regulator for human tissue and organs

Collection, transport and safety

Collection

How is the cord blood collected? 
The umbilical cord is clamped and cut in the same manner as it would be for normal delivery of the baby. Blood is then drawn from the umbilical cord into a cord blood collection bag. By law, anyone collecting cord blood must be appropriately trained and working under the authority of an HTA licence. The premises where the cord blood is collected must be risk assessed by a trained individual as fit for purpose and this assessment must be documented.

How soon after collection should the cord blood be stored?
For optimal viability it is recommend that the cord blood is stored as soon as possible following collection, and certainly within 72 hours. (NetCord-FACT 2013). Minimising time between the birth and cryopreservation (storage) is important to maintaining the quality of the cord blood unit.

Who is legally allowed to collect cord blood?
Since 5 July 2008, any person collecting cord blood must be acting under the authority of an HTA licence. The main responsibility for complying with HTA requirements lies with licensed establishments and organisations acting on their behalf. However, it is also important for parents to be familiar with this legal requirement so that they do not unknowingly allow collection by an unauthorised person. It would be unlawful for an unauthorised midwife or birthing partner to undertake the collection.

What happens to a cord blood unit that is collected unlawfully?
Licensed establishments are required to report all instances of unlawful cord blood collection to the HTA. Using an unauthorised person to collect cord blood may lead to contamination of the cord blood or inadequate collection. The HTA can require the disposal of any unlawfully collected cord blood.

Transport

What are the requirements for the transportation and storage of cord blood?
Cord blood banks should ensure that critical transport conditions such as temperature and time limits are defined, validated and maintained to preserve the quality and safety of tissues and cells, and that only packaging and containers that have been validated as being fit for purpose are used.

Safety

Is the cord blood screened for infectious diseases?
By law, donors of umbilical cord blood (the mother) must be screened and tested for evidence of infection with certain transmissible diseases.

The donor screening process typically involves the mother answering a series of health and lifestyle questions, designed to determine which tests are needed. A sample of the mother’s blood is then taken after the birth. Usually, this is at an appropriate time on the same day as the birth, but if that is not possible then the mother’s blood sample must be taken for testing within seven days after she has given birth.

Certain tests are mandatory for all donors. Diseases that must be tested for include: Human Immunodeficiency Virus (HIV), Hepatitis viruses B and C (HBV, HCV) and Syphilis. In certain circumstances, other tests such as Human T-lymphotropic virus Type I (HTLV-I) testing may be required, depending on the information provided during the donor screening process.