Sections 109-135; Schedules 13, 14 and 15
Summary
Part 4 of the Act puts the Health Services Safety Investigations Body (HSSIB) on a statutory footing. The organisation was previously established as the Healthcare Safety Investigation Branch (HSIB) under ministerial directions as part of the TDA and hosted by NHS Improvement. Schedule 13 describes the constitution of the HSSIB, including the appointment of the chief investigator and funding. Schedule 14 describes the exceptions to prohibition of disclosure of protected material. Schedule 15 contains consequential amendments relating to Part 4.
NHS Providers view and activity
The government introduced a Health Service Safety Investigations Bill to parliament in 2019. It had undergone pre-legislative scrutiny by a joint committee, and the government responded to its report. We contributed extensively to the joint committee's work, giving oral and written evidence. We also published a comprehensive briefing on the Bill, setting out the importance of the HSIB/HSSIB and its contributions to patient safety within the NHS, and our views on a number of key issues, in particular relating to the importance of protecting the integrity of safe space.
When the provisions from that Bill were included as a Part of the Health and Care Bill we were concerned that it would give coroners access to HSSIB protected materials. We raised our concerns each time the Bill was debated and built cross-party support around our proposed amendment which would remove this access. We are very pleased that the government accepted this amendment. We also opposed efforts to extend access to the Parliamentary and Health Service Ombudsman. This will ensure that safe space is sufficiently maintained, allowing those taking part in investigations to share information fully and without fear.
Key sections
Section 109 Establishment of the HSSIB; and Schedule 13
This together with Schedule 13 establishes the HSSIB as a body corporate. Schedule 13 describes the constitution of the HSSIB, including the HSSIB consisting of a chief investigator, executive members, a chair and at least four other (non-executive) members appointed by the secretary of state. The chief investigator is to be appointed by its non-executive members with the consent of the secretary of state. The non-executive must be in the majority and the non-executive members may not appoint more than five other executive members without the consent of the secretary of state. The HSSIB is funded out of money provided by parliament of such amounts as the secretary of state considers appropriate.
Section 110: Investigation of incidents with safety implications
Section 110 sets out that the function of the HSSIB is to investigate incidents occurring in England during the provision of health care that have or may have implications for the safety of patients (known as 'qualifying incidents'). The purpose of the investigations is to identify risks to patient safety and address those risks by facilitating the improvement of systems and practices. This covers incidents in the NHS or other health care services in England. The purpose of the investigations is not to assess or determine blame, civil or criminal liability or whether a regulatory body should take action in respect of an individual.
Section 111: Deciding which incidents to investigate
Under section 111, the HSSIB determines which qualifying incidents it will investigate, but this is subject to the secretary of state's power to direct the HSSIB to carry out an investigation of a particular qualifying incident or qualifying incidents of a particular description. The secretary of state's directions must be in writing, and may be varied or revoked by subsequent directions, and they may provide for a person to exercise discretion in dealing with any matter. Where the HSSIB discontinues an investigation, it must report that it has done so and give its reasons for doing so. Where the HSSIB determines not to investigate a qualifying incident, it may give notice with an explanation of its determination to anyone it considers to have an interest.
Section 112: Criteria, principles and processes
Section 112 requires the HSSIB to set out, following consultation with the secretary of state and others as considered appropriate, its criteria for determining which incidents it investigates, the principles and processes of investigations, the intended time periods for investigations, and the processes for ensuring patients and their families are involved. The HSSIB's criteria, principles and processes must be reviewed initially after three years, and then every five years.
Section 113: Final reports
The final report of an investigation, according to section 113, must state its fact findings and analysis, make recommendations for any person considered appropriate to action, and set out its conclusions. The report must focus on risks to patient safety and recommendations must focus on addressing those risks (rather than on the activities of individuals involved in the incident). It may not include an assessment or determination of blame, civil or criminal liability, or whether regulatory action in respect of an individual needs to be taken. The report may disclose information which is protected material if the benefits to patient safety outweigh any adverse impact on current or future investigations by deterring people from providing information, and any adverse impact on improving healthcare services. The report may not (without consent) name any individual who gave information to the HSSIB as part of the investigation or who was involved in the incident. The report must be sent to the secretary of state. As per section 114, an interim report may also be published.
Section 115: Draft reports
Section 116: Response to reports
Under section 115, the HSSIB must send a draft report to anyone it reasonably believes could be adversely affected by the report. It may also send a draft to anyone else considered appropriate. Recipients have the opportunity to comment. Section 116 sets out where an interim or final report includes recommendations for any person to action, the HSSIB must share the report with that person and specify a deadline for a written response. In that response, the person must set out the actions they propose to take further to the recommendations. That response may be published by the HSSIB.
Section 117: Admissibility of reports
No draft, interim or final report is admissible in civil or criminal proceedings, any employment tribunal, regulatory proceedings, or in an appeal relating to one of those proceedings. However, the High Court – following an application by a party to the proceedings or someone otherwise entitled to appear in them – may order that an interim or final report is admissible in such proceedings. The HSSIB may make representations to the High Court about any application here. The High Court may make this order only if it determines that the interests of justice served by admitting the report outweigh any adverse impact on current or future investigations by deterring people from providing information, and any adverse impact on improving healthcare services.
Section 118: Powers of entry, inspection and seizure
If considered necessary for an investigation, an investigator may enter and inspect premises (other than private dwellings), inspect and take copies of documents at the premises, inspect any equipment or items at the premises, and remove any document, equipment or other item (unless that would risk patient safety). These powers may be exercised in relation to premises where there is a Crown interest as long as the HSSIB gives reasonable notice. The secretary of state may certify, if in the interests of national security, that powers should not be exercisable in relation to premises with a Crown interest or only in certain circumstances.
Section 119: Powers to require information etc
Section 120: Voluntary provision of information etc
If necessary for the investigation, an investigator may require any person to attend an interview, provide information, and/or – if they are reasonably believed to be able to provide it – provide documents, equipment, or items. However, a person is not required to provide any information, document, equipment, or other item where it would risk patient safety, provision might incriminate the person, or if they would be entitled to refuse to provide that information or document in any court proceedings on the grounds of legal professional privilege. The HSSIB must reimburse the reasonable costs of any person attending to answer questions, and it may record the answers given. A person may also disclose any information, document, equipment, or other item to the HSSIB if they reasonably believe it necessary to enable the HSSIB's investigation function.
Section 121: Offences relating to investigations
It is an offence to intentionally obstruct an investigator or to fail without reasonable excuse to comply with the notice given to attend an interview or to provide information, documents, equipment or other item. It is also an offence to provide information to an HSSIB investigation which is known or suspected to be false or misleading in a material aspect – it is a defence, however, if the person can show they reasonably believed the information would assist the HSSIB, and at the time they informed the HSSIB that they knew or suspected it was false or misleading. An offence here is liable to a fine on summary conviction.
Section 122: Prohibition on disclosure of HSSIB material
This section sets out prohibitions on disclosure of HSSIB material. The HSSIB, or an individual connected with the HSSIB (past or present), must not disclose protected material to any person. 'Protected material' means any information, document, equipment, or other item which is held by the HSSIB or a connected individual for the purposes of the investigation function, and which relates to a qualifying incident, and which has not already been lawfully made public.
Section 123: Exceptions to prohibition on disclosure; and Schedule 14
Section 123 sets out exceptions to the prohibition on disclosure. Prohibitions do not apply to a disclosure which is required or authorised by Schedule 14 (see below), other provisions within Part 4 of the Act, or regulations made by the secretary of state (for example, by reference to the kind of material, the matters to which it relates, the person from whom it was obtained, the purpose for which it was produced or is held, or the purpose for which it is disclosed). Regulations may not require or authorise disclosure of protected materials by reference to the relevant qualifying incident. Regulations may provide for a person to exercise discretion in dealing with any matter.
Schedule 14 describes the exceptions to prohibition of disclosure of protected material. This includes the HSSIB disclosing protected material if:
- it is reasonably believed necessary for the purposes of the carrying out of the HSSIB's investigation function
- the chief investigator reasonably believes it necessary for the purposes of the prosecution or investigation of an offence relating to investigations or to unlawful disclosure
- the chief investigator reasonably believes it necessary to address a serious and continuing risk to the safety of any patient or to the public
- if it is reasonably believed that the person is in a position to address the risk
- if the disclosure is only to the extent necessary to enable the person to take steps to address the risk.
A person may apply to the High Court for an order that any protected material be disclosed by the HSSIB to the person for the purposes specified in the application (which can include onward disclosure). The HSSIB may make representations to the High Court about any application. The High Court may make an order on an application only if it determines that the interests of justice served by the disclosure outweigh: (a) any adverse impact on current and future investigations by deterring persons from providing information for the purposes of investigations, and (b) any adverse impact on securing the improvement of the safety of health care services provided to patients in England.
Section 124: Offences of unlawful disclosure
A person commits an offence if they knowingly or recklessly breach the prohibition on disclosure and knows or suspects that disclosure is prohibited. Further, a person not connected with the HSSIB to whom protected material is disclosed (in a draft report, in accordance with Schedule 14, or under the section 123 regulations made by the secretary of state) commits an offence if they knowingly or recklessly disclose the protected material to another person without reasonable excuse, and they know or suspect that it is protected material. An offence here is liable to a fine on summary conviction.
Section 125: Restriction of statutory powers requiring disclosure
Powers under any enactment (whenever passed or made) may not be used to require the disclosure of or seize protected material from the HSSIB (or an individual currently or formerly connected with the HSSIB).
Section 126: Co-operation
Where the HSSIB is carrying out an investigation into a qualifying incident and a 'listed person' is also carrying out an investigation into the same or a related incident, they must cooperate regarding practical arrangements to coordinate. Those listed persons are set out and include NHS foundation trusts and trusts, ICBs, NHS England, the CQC, and a number of other statutory bodies. The HSSIB must publish guidance about when a qualifying incident is to be regarded as related to another incident.
Section 127: Assistance of NHS bodies
The HSSIB must comply with any request by a relevant NHS body (such as an NHS foundation trust or trust or an ICB), NHS England or the secretary of state to assist in connection with carrying out an investigation into incidents occurring in the provision of NHS services or at premises providing NHS services. Giving assistance here includes disseminating best practice information, developing standards to be adopted and (unless impracticable) giving advice, guidance, or training. If requested, and as long as it does not interfere with its investigative function, the HSSIB may also give assistance to other bodies (such as independent providers) and charge them for this service.
Section 129: Failure to exercise functions
Section 130: Review
If the secretary of state considers that a significant failure by the HSSIB is occurring or has occurred in the exercise of its functions, the secretary of state may direct the HSSIB to exercise its functions in a specified manner and time period. The secretary of state may not direct the outcome of a particular investigation. If the HSSIB fails to comply, the secretary of state may exercise the functions specified or make arrangements for another person to do so. After four years, the secretary of state must lay before parliament a review into the effectiveness of the HSSIB's investigation function.
Section 131: Offences by bodies corporate
Section 132: Offences by partnerships
Where an offence under this Part is committed by a body corporate and it is proven that an officer of that body has consented or connived in this, or where the officer is negligent, the officer as well as the body corporate commits the offence and is liable. Parallel provisions are made for offences by partnerships.
Section 133: Obligations of confidence etc
Any disclosure of information, document, equipment, or other item which is required or authorised by or under sections 119 or 120 or Schedule 14 do not breach any obligation of confidence owed by the person making the disclosure or any other restriction on disclosure. Nothing within Part 4 of the Bill requires or authorises a disclosure of information which would contravene data protection legislation. When considering whether a disclosure would breach data protection legislation, it should be taken into account that the Bill requires or authorises disclosure.
Section 134 and Schedule 15: Consequential amendments to Part 4
This section introduces consequential amendments through Schedule 15.