Communication difficulties - Cord blood

Essential information

Obligatory
  1. All mothers must:
    1. Fully understand the donation process.
    2. Give their informed consent to the process and to the testing of their blood for diseases that may affect the suitability of their baby's stem cells/tissues for use.

  2. Third party interpreters:
    If they are to be present at any part of the selection procedure where there is an exchange of confidential information between the mother and the qualified healthcare professional, they must:
    1. Understand the importance of providing an accurate and truthful translation of the information provided, to enable the tissue/cell establishment to comply with regulatory requirements
    2. Not be personally known to the mother.
    3. Fully understand their duty of confidentiality and the confidential nature of any information obtained from the donor.

Supporting information

See if relevant
Additional information

The UK Blood and Tissue Services are aware of their duties under Race Relations and Disability Discrimination Legislation and will, whenever and wherever reasonable, try to provide facilities for individuals whose first language is not English, or who have other difficulties in communicating. Potential donors with such difficulties are advised to seek advice from their local Blood and Tissue Service before offering to donate stem cells to see if their needs can be met.

Every mother must:

  1. Be provided with accurate educational materials, which are written in terms which can be understood by members of the general public.
  2. Complete a health and medical history questionnaire and undergo a personal interview performed by a healthcare professional.
  3. Provide written informed consent to proceed with the donation process which must be countersigned by the qualified healthcare professional responsible for obtaining the health history.

A qualified healthcare professional may assist a mother in the completion of the health and medical history questionnaire and in understanding the consent statement and any other information provided by the Tissue Service. To facilitate comprehension, it is permissible to use alternative formats (e.g. a language other than English, audio, computer, Braille) for the information leaflets, the health and medical history questionnaire and consent statements. The mother must be able to clearly demonstrate they have understood this material. At present, there is no standardised way of assessing comprehension so this will be a personal judgement made by the healthcare professional.

Use of third party interpreters:

It is permissible for any third party to act as an enabler by helping to reassure the mother and to assist in establishing effective communication between the mother and the healthcare professional. The third party must not however be present during any exchange of confidential information, unless they are not personally known to the mother and understand the need to accurately and truthfully communicate all the information, including personal and confidential information, provided by the person giving consent. Confidential parts of the process include the evaluation of the health and medical history questionnaire, the medical interview and the obtaining of valid consent. Any third party, with the permission of the mother, may accompany the mother through other parts of the donation process that do not include the exchange of confidential information.

Rationale:

There is concern that the use of third parties during any exchange of confidential information between the mother and the healthcare professional may compromise the confidentiality of the mother and the safety of any donated material. Interpreters are often part of a close community, or a family member, and this may inhibit or embarrass the mother in any confidential exchange of information. This may result in the non-disclosure of sensitive information that could affect the individual's eligibility to donate. If a third party is not fully aware of the need to accurately and truthfully communicate all the information, including personal and confidential information, provided by the person giving consent, this may make the interpretation of information incomplete and potentially put both the mother and the donated material at risk. There is also a requirement to communicate the results of any testing performed by the Tissue Services that may be of relevance to the mother or her baby's health in a way that protects their confidentiality. The continuing availability of an independent interpreter, to maintain confidentiality, should be taken into account when deciding if an individual mother may be accepted.

Reason for change:
1. To clarify that interpreters and translators do not need to understand all the regulatory requirements of the Human Tissue Act, but are aware of the importance of providing a truthful and accurate translation to enable the tissue/cell establishment to comply with regulatory requirements. 2. To clarify that interpreters and translators have a duty of confidentiality.
Version details:

CB-DSG Edition 203 Release 19 (17 March 2015)