Using these guidelines

The Cord Blood Donor Selection Guidelines (CB-DSG) apply to donations of cord blood stem cells from placentae for therapeutic use.

The CB-DSG forms a constituent part of Chapter 22 of the Guidelines for the Blood Transfusion and Tissue Transplantation Services in the UK.

JPAC is responsible for these guidelines and receives professional advice from its specialist Standing Advisory Committees and other relevant expert groups. The CB-DSG is primarily reviewed and updated by the Standing Advisory Committee on Cellular Therapy Products (SACCTP). It is reviewed regularly to ensure that donations are of the highest quality and of sufficient quantity to meet the needs of recipients.

Comments about the content of the CB-DSG, including notification of errors, omissions and suggestions for improvements, should be sent to JPACOffice@nhsbt.nhs.uk.

General principles

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 UK Blood and Tissue Service (UKBTS).

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 Clinical Support Officer.

The mother must be evaluated for their eligibility to donate their infant's cord blood by 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.

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Use of the A to Z index

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 to Z index. 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 Clinical Support Officer.

Any new health risks identified during the donor selection process should be notified to SACCTP so that they can be considered for incorporation into future revisions of the CB-DSG.

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Guideline terminology

Please note, not all of the terms given below appear on every guideline entry.

Terms used for each section of an entry

Also known as

Alternative names for the entry.

Definition(s)

Clarification of key terms and concepts within the entry.

Includes

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

Excludes

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

Obligatory

Reasons why a donor must not donate.

Discretionary

Reasons why a donor 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 donor fulfils these requirements, as well as all others that apply, then they can be accepted.

See if relevant

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

Additional information

Further detail as to why any particular action is required.

Terms used within the text of an entry

Must not donate

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

If the deferral depends on time-related factors, the donor must be clearly advised when they will become eligible to donate again.

If the deferral is not time limited (i.e. it is likely to be permanent) the donor must be clearly advised why they cannot donate.

See

The specified guideline entry must be consulted.

Refer to a Designated Clinical Support Officer

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

Information provided at the end of each entry

Reason for change

A brief summary of the most recent changes to the entry.

Version details

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

Document

A link to the relevant Change Notification detailing the most recent update to the entry, if applicable.

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Medication

The underlying illness suffered by a donor, 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 their recipients. However, donors 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.

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Version control

The CB-DSG is under the continuing review of SACCTP and the Standing Advisory Committee 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.

Terms used for version control of the guidelines

Change Notification

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

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

Edition

An extensive revision of the entire set of guideline entries.

Release

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

Issue

Changes to the one or more entries in 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.

The Quality Manager of each UKBTS will be notified of upcoming changes by electronic distribution of a Change Notification.

The Quality Manager is responsible for effecting changes to locally held copies of the guidelines, or to information adapted from the guidelines for use within their respective service. An effective version control and change procedure must be in place to ensure only current versions of the guidelines are in use and that all authorised copies, electronic and paper, are traceable.

Live version of the guidelines (this website)

The website will always display the current version of each guideline entry, as shown in the A to Z index, and each entry will shown the date of its most recent update. Changes will be published on the website on the effective date given in the relevant Change Notification.

Offline version of the guidelines (source files)

A source file is a downloadable copy of the guidelines. A source file containing the current version of the guidelines is always available on the Source files page.

In addition, whenever a Change Notification is distributed to indicate upcoming changes, an updated source file incorporating those changes will be made available. This will supersede the current source file on the effective date of the Change Notification and any previous source files will be removed.

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