Responsibility for the Maternity and Newborn Safety Investigations (MNSI) programme moved to CQC on 1 October 2023. It was previously run by the Healthcare Safety Investigation Branch (HSIB).
This page sets out how MNSI and other parts of CQC share safety concerns. How we do this follows a formal information sharing agreement, which was made when the programme transferred to CQC.
Key principles behind the way we share concerns
CQC is the independent regulator of health and social care. It monitors, inspects, assesses and rates services, and publishes its findings. It also has civil and criminal enforcement powers.
MNSI's investigations focus on learning from maternity and newborn safety incidents. We do this to help improve patient safety in maternity and neonatal services. We do not aim to attribute blame or liability.
Why MNSI and CQC share information
The MNSI team must sometimes share information with others in CQC to support CQC's work as a regulator. It's important to be aware that the principle of 'safe space' does not apply to MNSI. This means the information people give as part of MNSI investigations may be shared with regulatory and enforcement teams within CQC. This includes CQC taking civil or criminal enforcement action.
The MNSI team may sometimes need to provide written or oral evidence for civil or criminal enforcement action taken by CQC.
When information or documents are given to CQC for one purpose, CQC can use them for other purposes as well, as part of their regulatory function. If this involves sharing personal data, this will follow UK data protection regulations.
One of the types of incident MNSI investigates is when a baby has a severe brain injury that occurs within the first 7 days of life. The MNSI team may still investigate if a family or registered provider has concerns about the care provided but the baby is found not to have a severe brain injury. This is to understand concerns relating to safety that did not result in harm, the impact the care has had on the family and to help the service improve. If this happens, the MNSI team must share relevant information from its investigation with CQC's regulatory and enforcement teams to support CQC's work as a regulator.
How and when MNSI shares concerns and information with other parts of CQC
This section sets out the circumstances under which the MNSI team will:
- tell CQC's regulatory and enforcement teams about safety concerns found during investigations
- share information when the regulatory and enforcement teams ask for it to help fulfil CQC's legal duties.
If the MNSI team finds serious safety concerns during an investigation, it will:
- notify CQC's regulatory and enforcement teams of its concerns in writing. It will do this within one working day of the decision being made by the MNSI concerns panel. The team will explain the details of its concerns. The panel will meet within 24 working hours after concerns are escalated. This follows MNSI’s safety concerns escalation procedure. The provider is always informed of safety concerns raised and of any notification to the CQC and other organisations or groups, like professional regulatory bodies or the police.
- give CQC's regulatory and enforcement teams all the relevant information about its concerns. This includes materials from its investigation, when requested, as quickly as possible.
- inform CQC's regulatory and enforcement teams in writing of any changes. For example, this might be a change in the nature or seriousness of the concerns. It will do this as soon as possible.
When the MNSI team does this, it will give CQC’s regulatory and enforcement teams more information as it becomes available. This could include responses from the provider or that the provider has not responded. This will then follow CQC's escalation procedure.
If the MNSI team suspects a regulatory offence by a registered provider or manager, the team will tell CQC's regulatory and enforcement teams. It will do this in writing within one working day of the MNSI concerns panel making a decision. It will include detailed information about the concerns. The MNSI concerns panel will meet within 24 working hours after the concerns are identified.
If similar concerns arise across more than one MNSI investigation, this may trigger CQC's emerging concerns protocol. If this happens, the MNSI team must share all related information with the regulatory and enforcement teams. It must do this within one working day of concerns being the reviewed and understood. This applies whether or not the concerns meet the official serious safety concerns criteria.
If the regulatory and enforcement teams ask the MNSI team for information it has collected, to help CQC to fulfil its legal duties, the MNSI team must promptly share all relevant information. These legal duties include seeing if there is a reason to suspect a criminal offence.
How and when the regulatory and enforcement teams share concerns and information with MNSI
The regulatory and enforcement teams will notify the MNSI team when they do one of the following things:
- issue a Letter of Intent, Warning Notice, Notice of Proposal or Notice of Decision relating to a maternity or neonatal service
- make an application to the Magistrates' Court for urgent cancellation of a maternity or neonatal service
- decide to carry out a formal criminal investigation into the registered provider's maternity or neonatal care
- make a decision to prosecute the registered provider over its maternity or neonatal care.
They will do this promptly in writing or by providing copies of the relevant documents.
If the MNSI team asks for information about a notification they received from the regulatory and enforcement teams as described above, the regulatory and enforcement teams will give the MNSI team the relevant information the team needs from the original notification to perform its functions.