The UK Safety and Quality Regulations 2005 and the EU Blood Safety Directive require that serious adverse incidents and serious adverse reactions related to blood and blood components are reported to the MHRA, the UK Competent Authority for blood safety. This information is vital to the work that the Serious Hazards of Transfusion (SHOT) uses to compile its reports. Further details on reporting can be found at: Appendix 3: Independent Investigation (level 3) Introduction This appendix describes the process for undertaking independent investigations for the purposes of learning to prevent recurrence. It describes the circumstances in which an independent investigation may be required and the process for commissioning and managing these types of investigation. It also outlines the potential scope of independent investigations and the circumstances where it may be necessary to involve the expertise of NHS England Regional investigation teams. It does not describe the regional process that has been established for investigating homicide by those in receipt of mental health care. This process is described in appendix 1. This appendix should be read in conjunction with the main Framework. Scope Investigations carried out under this Framework are conducted for the purposes of learning to prevent recurrence. They are not inquiries into how a person died (where applicable) as this is a matter for Coroners. Neither are they conducted to hold any individual or organisation to account. Other processes exist for that purpose including: criminal or civil proceedings, disciplinary procedures, employment law and systems of service and professional regulation, such as the Care Quality Commission and the Nursing and Midwifery Council, the Health and Care Professions Council, and the General Medical Council. In circumstances where the actions of other agencies are required then those agencies must be appropriately informed and relevant protocols, outside the scope of this Framework, must be followed. An independent investigation is an investigation into an incident is both commissioned and undertaken independently of those directly responsible for and directly involved in the delivery of the elements that the investigation is considering. This guidance considers two of independent investigation: The first is an independent provider-focussed investigation considering the specific care given to a patient or patients by one or more providers. This type of investigation should be commissioned by the commissioner of the care within which the serious incident occurred and undertaken by individuals who are all independent of the provider(s) in question. The second type is a independent investigation of the role of the commissioning system or the configuration of services, which must be
The UK Safety and Quality Regulations 2005 and the EU Blood Safety Directive require that serious adverse incidents and serious adverse reactions related to blood and blood components are reported to the MHRA, the UK Competent Authority for blood safety. This information is vital to the work that the Serious Hazards of Transfusion (SHOT) uses to compile its reports. Further details on reporting can be found at: Appendix 3: Independent Investigation (level 3) Introduction This appendix describes the process for undertaking independent investigations for the purposes of learning to prevent recurrence. It describes the circumstances in which an independent investigation may be required and the process for commissioning and managing these types of investigation. It also outlines the potential scope of independent investigations and the circumstances where it may be necessary to involve the expertise of NHS England Regional investigation teams. It does not describe the regional process that has been established for investigating homicide by those in receipt of mental health care. This process is described in appendix 1. This appendix should be read in conjunction with the main Framework. Scope Investigations carried out under this Framework are conducted for the purposes of learning to prevent recurrence. They are not inquiries into how a person died (where applicable) as this is a matter for Coroners. Neither are they conducted to hold any individual or organisation to account. Other processes exist for that purpose including: criminal or civil proceedings, disciplinary procedures, employment law and systems of service and professional regulation, such as the Care Quality Commission and the Nursing and Midwifery Council, the Health and Care Professions Council, and the General Medical Council. In circumstances where the actions of other agencies are required then those agencies must be appropriately informed and relevant protocols, outside the scope of this Framework, must be followed. An independent investigation is an investigation into an incident is both commissioned and undertaken independently of those directly responsible for and directly involved in the delivery of the elements that the investigation is considering. This guidance considers two of independent investigation: The first is an independent provider-focussed investigation considering the specific care given to a patient or patients by one or more providers. This type of investigation should be commissioned by the commissioner of the care within which the serious incident occurred and undertaken by individuals who are all independent of the provider(s) in question. The second type is a independent investigation of the role of the commissioning system or the configuration of services, which must be
serious-incidnt-framwrk-upd2.docx