Patient follow-up

Adverse events

To comply with HTA licence requirements, Oxford Cell and Tissue Biobank (OCTB) needs to know how the patient is progressing after tissue procurement and to report any serious adverse event (SAE) related to tissue procurement to the competent authority in a timely manner.

If any adverse event occurs, OCTB must be informed immediately.

Typical adverse events include but are not limited to:

• complications associated with the surgical procedure such as severe haemorrhage resulting in loss of a gonad, perforation of bowel during laparoscopic procedure
  
• early post-operative complications such as wound infection or wound breakdown
• delay to discharge or start of treatment related to a complication related to tissue procurement
• other adverse events occurring post discharge which is directly related to tissue procurement.

OCTB is required to report any serious adverse event to HTA within 24 hours of being informed.

Adverse Event Reporting Form - Forms and documents

Ongoing follow-up

If a patient wishes to use tissue in the future it will be important to know what treatment was actually administered.

The referral form includes details of planned treatment, so to obtain details of actual treatment OCTB will need a copy of the patient's 'end of treatment summary' letter.

Growth, puberty and fertility are all aspects of aftercare and are very important for ongoing fertility counselling, including appropriate counselling about tissue use.

We would therefore appreciate, as well as having a copy of the 'end of treatment summary', also receiving a copy of the long term follow-up annual review summary and in particular, details of puberty and fertility status, AMH/FSH/LH +/- oestradiol or testosterone test results.

Patient death

If a patient dies it is important that OCTB is informed immediately so that we can update records.

This will prevent inappropriate contact with families of patients who have died, and ensure that we treat any stored tissue in accordance with the wishes of the patient and/or their family.

OCTB must be added to the standard list of agencies to be informed.

Death Notification Form - Forms and documents

Use of tissue

Please visit 'Patients with stored tissue'

Patients who have undergone tissue re-implantation are followed up regularly by the FFPO gynaecology team.

Consent

As part of the tissue procurement and storage consent process, patients and/or their families are aware that we will make direct contact to ask for their comments, suggestions or feedback.

We also need to ensure, where appropriate, that patients who were under 18 years of age at the time of tissue collection are able to re-consent in their own right as an adult.

Data protection

Oxford Cell and Tissue Biobank, in undertaking its core activities, collects, holds and processes information, which is personal and identifiable to living individuals.

Under the provisions of the Data Protection Legislation and in its capacity as a Data Controller, OCTB ensures that all measures possible will be taken to ensure compliance with the provisions of the Act.

Privacy Notice - Oxford University Hospitals

Feedback

As part of our commitment to continuous improvement, if you have any comments, suggestions or feedback, please contact us.