The human endeavor can be predicted to fail but harm from failure can be mitigated by managing associated risks. The term ‘horizon event’ has entered the risk management vocabulary implying that the threat is new and ‘below the horizon’. The risk could be new such as another vCJD, something misjudged as a threat, such as Xenotropic Murine Leukemia Virus-related Virus (XMRV), or something not previously recognised, such as West Nile Virus. In all cases, however, these could have been predicted.
Risks are inherent in the use of MPHO. They may occur in the donation of the ‘product’ or within the manufacturing process, due to external factors or through human error. With basic epidemiological data, however, hazards can be identified early. Recording of information such as the source of an infection, the agent/disease, the risk level as well as a description of the problem can prove to be effective in detecting a potential crisis. An example involved the appearance of unexpected infections in a number of patients who had received bone marrow transplantations. The contamination was ultimately linked to a liquid nitrogen tank where all harvests had been stored.
In assessing an early warning reaction, an analysis of risk/benefit has to be the guiding principle. The risks to be prevented and the down sides of ‘preventive action’ need to be identified. Risk Management is a day-to-day function. For example, aviation can be used as a model since it, like transplantation, is inherently dangerous. For example, one could use the table of aviation accidents/incidents in Australia, which included details of the aircraft, damage etc., reported over a two month period in 2010. With respect to transplantation risk management, aviation provided the following learning points:
Global community ownership is possible
• A NO BLAME culture for reporting can work
• Self-reporting of ‘I learned from that’ also works
• Don’t hide mistakes no matter how uncomfortable
• Everything human is fallible
• Rapid dissemination is essential
• Get the information to where it matters in real time
• Differentiate between doing the right thing from the correct thing
• Don’t let the perfect be the enemy of the good