Dr. Kathleen MacLellan:

There are probably a few pieces to this. First, I concur with the Deputy. The first patient safety principle is that if something has happened we secure the safety of the individual patient, then we secure the safety of the patients around that patient and then we secure the safety of the patients across the system. In terms of management at local level, a new incident management framework was launched in January last across the Health Service Executive which provides significant guidance around the management of incidents. We have our national incident management system and all incidents, regardless of level of risk, should be reported to that system. An earlier question from the Deputy was about how close to the site that happens. It happens at the level of each organisation. Just as the Deputy talks about a freedom of information officer there should be a risk management officer, a patient safety and quality officer or a clinical effectiveness officer there.

That all fits very well into what we are proposing within the Patient Safety (Licensing) Bill, which is strong structures and enforcement powers around clinical governance. Clinical governance is the patient safety culture management system across a hospital that allows patient safety incidents, patient safety issues, clinical audit and all those good pieces to happen in a timely way. That requires that every organisation should have a patient safety and quality operating framework. We strongly believe that is part of clinical governance mechanisms. Part of HIQA's role will be to be assured that there are such clinical governance mechanisms in place in a standard way across the country so every organisation has the requirements in place to meet those standards be they, depending on the size of the hospital, level of risk managers, patient safety and quality officers and so forth, so those people are on site training, supporting and ensuring that the reporting of incidents is happening.

I should also say that we commissioned both HIQA and the Mental Health Commission to develop standards for the conduct of reviews. That refers back to some of the previous questions about the time it takes for reviews and the reporting of incidents. They are published and are now being implemented across the system. These are the types of standards that we would like to see monitored by HIQA across the system. It is already monitoring them. There are processes in place.

The other piece is that the quality assurance and verification division is in the process of developing a patient safety alert system across the system. It is very similar to what the Deputy described. An alert can go out very quickly to the system if an incident occurs that requires information to go across the system and should happen very quickly. All those pieces should fit within a strong, structured, legislated for clinical governance framework, which was a key element of the Sláintecare report as well. We would very much support that. With regard to clinical governance, it is not the single issues or actions that make the difference but the combination of all the actions. We see clinical governance as encompassing education, continuing professional development, clinical audit, clinical guidelines, clinical effectiveness, risk management, openness, patient engagement and so forth. All of those would be key components of the mandatory regulations and they would be regulated. There are significant powers and opportunities being proposed and outlined within this Bill. There will then be significant enforcement powers through HIQA's work in providing licences to organisations.