Using these guidelines

These guidelines apply to donations of cord blood for therapeutic use.

Cord blood is taken from the placenta of newborn infants. As placentae are normally treated as a waste product there is no risk to the infant or the mother. To ensure the donated material is safe to use it is important to exclude risk factors in the mother. On occasions, tests may need to be performed on the cord blood but no additional testing of the infant should be required. Unless stated specifically, all guidelines apply to the mother of the infant whose cord blood is collected.

Mothers are selected to ensure that their infant's cord blood stem cells are unlikely to harm any recipient.

The ultimate responsibility for the selection of donors rests with the Medical Director of each Blood Transfusion and Tissue Transplantation Service in the UK.

The immediate responsibility is with the Qualified Healthcare Professional who must ensure that the mother donor fulfills the respective selection criteria. When it is not clear from these guidelines if an individual donor is suitable, no donation should be taken without discussion with a Designated Medical Officer.

The mother must be evaluated for their eligibility to donate their infant's cord blood by a a Qualified Healthcare Professional who has undergone appropriate training to use these guidelines to select or defer a donor. They must verify their assessment by signing the donation record.

Special note must be taken of the content of the Tissues safety entry.

It is the responsibility of the Qualified Healthcare Professional to ensure that the mother clearly understands the nature of the donation process, the health check and other medical information presented to them. Mothers are asked about confidential aspects of their medical history, hence great care must be taken over privacy and confidentiality.

Any medical condition or possible contraindication to donation, elicited at any point during the donation process, must be managed as indicated by its respective guideline entry. A complete list of available entries can be found in the A-Z index of the CB-DSG. Any collected material which, as a result, is unsuitable for clinical use must be clearly labelled as unfit for use.

If late information is provided by the mother, or through any other source, that the donation is medically unfit, this must be recorded and reported to the Designated Medical Officer.

Any new health risks identified during the donor selection process should be notified to the Standing Advisory Committee on Cellular Therapy Products, so that they can be considered for incorporation into future revisions of the CB-DSG.

The following terms may be used for each section of a guideline entry:

Also known as

Alternative names for the entry.

Definition(s)

Clarification of key terms and concepts within the entry.

Includes

Any conditions, treatments or other factors covered by the entry.

Excludes

Any conditions, treatments or other factors not covered by the entry.

Obligatory

Reasons why a mother must not donate.

Discretionary

Reasons why a mother may be permitted to donate.

These statements are conditional and all criteria that must be fulfilled will come before the final statement that they may be accepted.

If the mother fulfils these requirements, as well as all others that apply, then they can be accepted.

See if relevant

Other entries which may need to be consulted, depending upon the information provided by the mother.

Additional information

Further detail as to why any particular action is required.

The following terms may be used within the text of the entry:

Must not donate

The mother must not donate if any of the statements apply to them, unless a discretion clearly applies.

Often the exclusion will depend on time-related factors.

If a donation cannot be taken, the mother must be clearly advised why.

See

The specified entry must be consulted.

Refer to a Designated Medical Officer

When there is a need to seek further advice, the Designated Medical Officer is a suitably trained person authorised to undertake this task by the Medical Director or their nominated deputy.

The following information is provided at the end of each entry:

Reason for change

Provides information about the most recent changes to the entry.

Version details

Provides the Edition and Release number of the current version of the entry and the date of publication.

The underlying illness suffered by a mother, rather than the properties of any drug they are taking, is the usual reason for an ineligiblity to donate.

In general, traces of drugs in donations are harmless to any recipients. However, mothers treated with certain drugs are deferred for periods associated with the pharmacokinetic properties of the drug. Examples are drugs used to treat acne, psoriasis, and some prostate problems. All such drugs have their own entry.

The CB-DSG is under the continuing review of the Standing Advisory Committees on Cellular Therapy Products (SACCTP) and on Transfusion Transmitted Infection (SACTTI) to ensure that they are accurate and up to date.

All changes are the responsibility of the Professional Director of JPAC and have the approval of the Executive Working Group (EWG) and the JPAC Board.

The following document control terminology is used:

Change Notification

This notifies the Medical Director and the Quality Manager of each of the four UK Services to upcoming changes to the guidelines.

The implementation of any changes is the responsibility of the individual Services.

Edition

An extensive revision of the guidelines.

Release

Changes to the current Edition of the guidelines which involve a change to the medical or scientific content.

Issue

Changes to the current Release of the guidelines which do not involve a change to the medical or scientific content or have been made to correct an error or omission.

Each Release of the guidelines will be Issue 01 unless otherwise stated.

Changes to the live versions of the guidelines (this website)

The website will always display the most recent version of each entry.

Any errors should be notified to JPACOffice@nhsbt.nhs.uk.

Changes to the offline versions of the guidelines (Source Files)

The Quality Manager of each Blood Service will be notified of upcoming changes by Change Notification and will effect changes to local offline versions of the guidelines. Source Files for upcoming releases will be posted on this website prior to publication of any changes.

The Quality Manager is responsible for ensuring that there is an effective Version Control and Change Procedure in operation within their Service to ensure that only up-to-date versions are in use and that all authorised copies, electronic and paper, are traceable.

Individual users of the offline versions of the guidelines are responsible for ensuring that they are using the most recently published version.