A UK scheme for reporting serious adverse events and reactions associated with ocular tissue transplantation

Abstract

Reporting and investigation of serious adverse events and reactions associated with tissue and cell transplantation is a fundamental aspect of ensuring adequate levels of safety and quality and is a requirement of the European Union Directives on tissues and cells. In the UK, a system for the reporting and analysis of events and reactions associated with ocular tissue transplantation is well established. It is operated by a network of individuals and organisations, each with clearly defined roles and responsibilities, following written procedures for reporting and investigation. Analysis of reports indicates that the most important adverse reactions associated with this type of tissue transplantation are endophthalmitis (0.58%) and primary graft failure (0.3%). This system allows the analysis of all types of events and reactions by the professionals involved so that trends can be identified and services improved. Tools to evaluate the severity and imputability of individual events or reactions, such as those developed by the EUSTITE project, can be utilised to facilitate the selection of those cases meeting the criteria for reporting to the Competent Authority. This vigilance model has been shown to be effective and could be applied in other fields of tissue or cell transplantation.

Appendix: OTAG serious adverse events and reactions: standard operating procedure

Reporting of investigation

• 1. On recognition of a serious adverse reaction or event, (see Fig. 1), the clinician reports to the NHSBT Organ Donation and Transplantation (ODT) Duty Office on 0117 975 7580 as soon as possible and within 12 h of being aware of the serious event or reaction.

• 2. The ODT Duty Officer immediately contacts the on-call person at the appropriate Tissue Establishment (Eye Bank) and also informs the Duty Office Manager.

• 3. The clinician completes part A of the OTAG Adverse Reactions and Events reporting form. Forms should be sent by facsimile to the Tissue Establishment and the Duty Office Manager at ODT. The original should be kept within the patient’s medical case notes.

• 4. On receipt of the part A of the form the Duty Officer will telephone the surgeon to confirm receipt of the form.

• 5. The Tissue Establishment will notify the Duty Office of the assigned HTA number and the Duty Office will pass this information to the clinician responsible for the patient.

Note: Should the adverse reaction or event not involve a transplant centre then the reporting mechanism will start at the Tissue Establishment.

Initiation of investigation

• 1. The Designated Individual at the Tissue Establishment will report the serious adverse reaction or event to the Human Tissue Authority (HTA) before any investigation begins.

• 2. The designated individual at the Tissue Establishment will confirm to the Duty Office Manager at ODT that the HTA have been notified of the serious reaction or event.

• 3. Should confirmation not be received by the ODT Duty Office Manager that the HTA have been notified within 7 days of receiving part A of the reporting form, he/she will contact the Tissue Establishment to ensure that this is completed.

• 4. All investigations will be led by the Designated Individual at the Tissue Establishment.

Completion of investigation

• 1. Upon completion of the investigation, the Designated Individual at the Tissue Establishment will contact the ODT Duty Office Manager to advice of completion.

• 2. Part B of the OTAG Adverse Reactions and Events reporting form should then be completed. Two copies should be produced. One copy should be returned to the clinician and one should be sent to the ODT Duty Office Manager. The HTA will be sent the concluding report by the Designated Individual electronically through the HTA reporting system.

Further reporting

• 1. On a 6 monthly basis the ODT Duty Office Manager will produce a report on the number and types of serious adverse events and reactions and the investigations completed in the previous 6 months.

• 2. This report together with the outcome of the investigations will also be considered by the Ocular Tissue Advisory Group (OTAG) Audit & Analysis Sub Group, who will then report to OTAG.

• 3. Pending: The OTAG Audit & Analysis Sub Group will also receive a list of all SAER reported to the HTA from non CTS eye banks

• 4. OTAG will then report to the Clinical Governance Monitoring Group at ODT and through them to the NHSBT Governance and Audit Committee.

• 5. Pending: The OTAG Audit and Analysis Sub Group will also report to the HTA and advise of any recommendations made.