Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what criteria the Healthcare Safety Investigation Branch is required to meet in order to start an investigation.

The Healthcare Safety Investigation Branch (HSIB) conducts independent investigations of the most serious patient safety concerns in National Health Service funded care across England. Its purpose is to improve safety through effective and independent investigations that do not apportion blame or liability. HSIB has published a set of criteria for its national and maternity investigations.

For national investigations the main areas which HSIB consider when deciding whether to investigate an incident are:

- Outcome impact – the affect on the people involved, including physical and emotional harm; the impact on services and whether the incident has reduced the services ability to delivery safe, reliable care; and whether the public view has resulted in any loss of confidence in that area of healthcare;

- Systemic risk – any wider system risk associated with the safety issue, how common or widespread it may be and whether it spans different locations or areas of healthcare; how long it has taken to be recognised and whether concerns have already been raised; whether the safety issue can worsen or spread to other areas of healthcare; and

- Learning potential – HSIB will always consider the potential to learn from an incident, leading to positive changes and improving patient safety across the healthcare system.

The main areas which HSIB follow for maternity investigations are:

The Royal College of Obstetrics and Gynaecologists’ ‘Each Baby Counts’ criteria, which include all babies who are at least 37 weeks gestation born following labour who have one of the following outcomes:

- Intrapartum stillbirth (where the baby was thought to be alive at the start of labour but was born with no sign of life);

- early neonatal death (where the baby died within the first week of life from any cause);

- severe brain injury diagnoses; and

- maternal deaths (death of a woman whilst pregnant or within 42 days of the end of the pregnancy, from any cause related to or aggravated by the pregnancy or its management, but not from accidental or incidental causes).