Workshop - Serious Adverse Events and Reactions

1. Workshop - Serious Adverse Events and Reactions 25 March 2009

2. Aims of the workshop • Discuss examples of incidents and determine whether they should be reported to the HTA or not • If reportable, determine whether as a Serious Adverse Event (SAE) or Serious Adverse Reaction (SAR) • Work through a case study of an incident with guiding questions

3. When should an SAE be reported? • An SAE should be reported to the HTA if: • inappropriate tissues/cells have been distributed for clinical use, even if not used • the event has implications for other patients /donors because of shared practices, services, supplies or donors • the event resulted in loss of irreplaceable autologous tissues or cells or any highly matched (i.e. recipient specific) allogeneic tissues or cells • the event resulted in the loss of a significant quantity of unmatched allogeneic tissues or cells

4. When should an SAR be reported? • Triggers for reporting (examples, not exhaustive): • transmitted infections (viral, bacterial, parasitic, fungal, prion), donor to recipient • transmitted infection – contaminated materials • hypersensitivity reactions • malignant disease transferred by tissue / cells • unexpected delayed engraftment / graft failure • immunological reaction due to tissue / cell mismatch • aborted procedure involving unnecessary exposure to risk e.g. wrong tissue supplied, discovered after patient is anaesthetised and the surgical procedure has begun

5. Would you report? If so, SAE or SAR? • Liquid nitrogen container runs out of LN2, 120 heart valves thaw and are discarded • Two corneas discarded in the tissue establishment due to technical error during dissection from the globe • Equipment failure during haematopoietic stem cell collection resulting in abandoning of procedure. The procedure was carried out successfully at a later date • Failure of remote alarm of temperature monitoring system of a fridge containing a large number of tissues and cells. Temperatures were maintained within acceptable range • Cryopreserved skin past its expiry date is distributed and used on a burned patient. Discovered after the procedure • Fracture in an irradiated massive allograft (femur) two months after transplant • A frozen femoral head is held by a courier company for 72 hours in a holding depot rather than being delivered immediately (courier company used by many tissue establishments in the country) • A cornea is swabbed in theatre prior to being transplanted – subsequent culture shows growth of Staphylococcus epidermis (previous cultures at the tissue establishment negative and no evidence of infection in the recipient) • A dry shipper containing allogeneic bone marrow donation being transported for immediate transplant is stolen from the courier

6. Would you report? If so, SAE or SAR? • Liquid nitrogen container runs out of LN2, 120 heart valves thaw and are discarded • Answer - reportable, SAE. The event resulted in the loss of a significant quantity of unmatched allogeneic tissues or cells • Two corneas discarded in the tissue establishment due to technical error during dissection from the globe • Answer - not reportable. Does not meet any of the criteria for reporting • Equipment failure during haematopoietic stem cell collection resulting in abandoning of procedure. The procedure was carried out successfully at a later date • Answer - would be an SAE and reportable only if the equipment failure is something that other haematopoietic stem cell collection centres should be informed about

7. Would you report? If so, SAE or SAR? • Failure of remote alarm of temperature monitoring system of a fridge containing a large number of tissues and cells. Temperatures were maintained within acceptable range • Answer - not reportable. Does not meet criteria for reporting unless the defect in the alarm system is inherent and the system is used by other tissue establishments • Cryopreserved skin past its expiry date is distributed and used on a burned patient. Discovered after the procedure • Reportable, SAE. Inappropriate tissues/cells have been distributed for clinical use, even if not used • Fracture in an irradiated massive allograft (femur) two months after transplant • Answer - reportable as a suspected SAR

8. Would you report? If so, SAE or SAR? • A frozen femoral head is held by a courier company for 72 hours in a holding depot rather than being delivered immediately (courier company used by many tissue establishments in the country) • Answer - reportable, SAE. The event could have implications for other patients or donors because of shared practices, services, supplies or donors • A cornea is swabbed in theatre prior to being transplanted – subsequent culture shows growth of Staphylococcus epidermis (previous cultures at the tissue establishment negative and no evidence of infection in the recipient) • Answer - not reportable. Does not meet any of the criteria for reporting • A dry shipper containing allogeneic bone marrow donation being transported for immediate transplant is stolen from the courier • Answer - reportable, SAE. The event resulted in loss of any irreplaceable autologous tissues or cells or any highly matched (i.e. recipient specific) allogeneic tissues or cells

9. Case study Your tissue bank has supplied a heart valve for immediate surgery in a young child. The hospital calls to inform you that the size of the valve was incorrect on the label and the accompanying documentation and they could not use the valve. The label and documentation showed the size they had requested but the valve was very much larger. They proceeded with the operation as the error was discovered after the patient had been anaesthetised; they used a prosthetic valve instead. The patient will need anticoagulation treatment and re-operation.

10. Questions for discussion • Would this be an SAE or SAR? • Who would report to the HTA? • What information would you provide to the HTA? • When would you provide this information to the HTA? • What follow up information would you provide to the HTA? • What Corrective and Preventative Action would you undertake? • What are the most important actions (up to five) that your Tissue Establishment should undertake following this report?

11. Questions for discussion • Would this be an SAE or SAR? • Covers both. SAE - inappropriate tissues/cells have been distributed for clinical use. SAR - due to the event the patient will need anticoagulation treatment and re-operation • Who would report to the HTA? • Licensed establishments should have an agreement in place with end users to ensure that any SAEARs are reported to the licensed establishment. The tissue establishment would then report this to the HTA • The DI has overall responsibility for notifying the HTA of any real or suspected SAEAR that occur at their licensed premises / premises under a third party agreement or end user establishments • Persons Designated / others may register online for an account

12. Questions for discussion • What information would you provide to the HTA? • Type of tissue/cell involved • Quantity • List of relevant material IDs • Whether the reaction was in the donor or recipient • Type of suspected Serious Adverse Reaction • Consequences of the reaction • Action taken in response to the reaction • When would you provide this information to the HTA? • The information should be provided as soon as it is identified

13. Questions for discussion • What follow up information would you provide to the HTA? • Root cause analysis • What Corrective and Preventative Action has been undertaken at the establishment • Information on the condition of the patient • What Corrective and Preventative Action would you undertake following this reaction? • What are the most important actions (up to five) that your Tissue Establishment should undertake following this report?

14. www.hta.gov.uk