Select committee inquiry

Follow-up to PHSO report on clinical investigations

Closed

Public Administration and Constitutional Affairs Committee · Opened 20 January 2016 · Closed 25 October 2017

4 recommendations · 16 conclusions
Inquiry on parliament.uk ↗

What the inquiry looked at

“The Committee's report welcomes the creation of HSIB as a critical step towards improving how the NHS in England investigates patient safety incidents. But for it to succeed the Government must bring forward primary legislation making it fully independent from the NHS and securing a statutory 'safe space' in which medical professionals, patients, their families and carers, can speak candidly about the most serious risks to patient safety, in a 'no blame' environment. HSIB must also take full responsibility for setting national investigations standards and providing appropriate accreditation and training for local investigators.”

The committee's words, from the inquiry page on parliament.uk ↗.

What it found

In the committee's words, from the summary of 1st Report - PHSO review: Quality of NHS complaints investigations ↗

In December 2015 the Parliamentary and Health Service Ombudsman (PHSO) published a Review into the quality of NHS complaints investigations where serious or avoidable harm has been alleged highlighting concerns about the ability of NHS organisations to conduct effective clinical investigations. Following a review of 150 NHS investigations in which avoidable harm or death had been alleged, PHSO found that “NHS Trusts are not always identifying patient safety incidents and are sometimes failing to recognise serious incidents” and that the quality of investigations is “inconsistent, often failing to get to the heart of what has gone wrong and to ensure lessons are learnt.”

The Public Administration and Constitutional Affairs Committee (PACAC)

subsequently conducted a short inquiry into the issues identified in the PHSO report.

This built on the work of PACAC’s predecessor committee, the Public Administration Select Committee (PASC), which recommended in March 2015 that the Government create an independent and transparent national clinical investigations function, modelled on the Air Accidents Investigation Branch, which would create a ‘safe space’

for people directly involved in the most serious patient safety incidents - as patients, clinicians, or family members - to speak honestly and openly in the interests of learning from mistakes. The Government subsequently accepted this recommendation in its July 2015 response Learning not Blaming and set up an Expert Advisory Group to produce more detailed proposals for the new Investigation Branch. The EAG’s final report was published on 12 May 2016.1 During the course of our inquiry both the Department of Health and NHS England responded positively and constructively to the PHSO’s report. Both acknowledged that NHS England currently lacks a broad and deep high quality clinical investigations capability and that it does not deal with complaints effectively. The establishment of a national clinical investigations function, the Healthcare Safety Investigation Branch (HSIB), is a critical step towards improving how NHS organisations handle clinical investigations, although its remit does not include complaints handling.

However, for HSIB to succeed it must be underpinned by primary legislation, providing for its independence and creating the crucial ‘safe space’ in which doctors and patients, as well as their families and carers, can provide full and candid contributions to patient safety investigations, without fear of punitive sanctions. HSIB must also take full responsibility for setting national standards and establishing appropriate accreditation and training for local investigators. This is essential if HSIB is to drive up the quality of clinical investigations at a local level, where, given its own limited capacity, the vast majority of investigations will continue to take place. The Committee’s recommendations on HSIB fit closely with those made by the EAG in its final report. There is a clear consensus that the Government must do more to ensure HSIB’s independence and effectiveness in reducing risks to patient safety, but there is still a long way to go to realise the Secretary of State for Health’s ambition of creating “the world’s largest learning organisation”.

1 Report of the Healthcare Safety Investigation Branch Expert Advisory Group (May 2016).

What the government said

The government responded on 18 October 2016.

Summary written by Accountability Index from the government's response.

The government welcomes the report and states it is "absolutely determined that HSIB will operate independently", but maintains that HSIB should be hosted by NHS Improvement and says it lacks primary legislation to go further.

  • On independence, the government does not commit to primary legislation, saying it "would need primary legislation to further bolster the independence of HSIB which we do not have", and says it has "agreed to review the current arrangements within two years".
  • On 'safe space', the government "agrees that the concept of safe space is critical" and says it will bring forward measures similar to those for the Air Accident Investigation Branch. It envisages that such information would not be disclosable under the Freedom of Information Act, but says this "would have to be balanced with the principle of transparency".
  • On a Just Culture Task Force and historic unresolved cases, the government is "giving further consideration" and will respond "in due course". It anticipates that a large public inquiry into historic cases "is unlikely to meet the aims of the EAG".
  • On a public service ombudsman, the government says it "will publish draft legislation to create a public service ombudsman in due course". On NHS complaints handling, it "will wish to take stock of this programme before committing to any further action".

How the inquiry ran

Each dot is a dated item listed on this page, from the inquiry's opening on 20 January 2016 to its close on 25 October 2017.

  1. Oral evidence 23 Feb 2016
  2. Report 2 Jun 2016
  3. Government response 18 Oct 2016
  4. Correspondence 21 Mar 2016

What it recommended 4 recommendations · 16 conclusions

1During the course of our inquiry, the Department of Health and NHS England both gave...
Concluded (the committee's words)
During the course of our inquiry, the Department of Health and NHS England both gave positive and constructive responses to the PHSO’s report. We commend their honesty in acknowledging that NHS England currently lacks a high quality clinical investigations capability and that it does not deal with complaints effectively. The establishment of HSIB is a critical step towards improving how NHS organisations handle clinical investigations, although its remit does not include complaints handling. However, the Department of Health and NHS England must go further to achieve the transformation “from a blame culture to a learning culture” as quickly as possible. The rest of this Report will assess the proposals that have been made to date and consider what more must be done to deliver the “whole system approach” first called for by PASC in March 2015. In particular we are in agreement with many of the HSIB EAG’s recommendations and believe that there is a consensus across the sector in favour of an independent, transparent and “no blame” Investigation Branch, which Government cannot ignore and must implement in full as a matter of urgency. Despite statements to the contrary, the Secretary of State’s Directions currently fall short of providing this framework.
2The Committee welcomes the creation of the Healthcare Safety Investigation Branch as a national clinical...
Concluded (the committee's words)
The Committee welcomes the creation of the Healthcare Safety Investigation Branch as a national clinical investigations function. It is right that this body should focus on those risks which pose the greatest threat to patient safety. However, following the publication of the Secretary of State’s Directions, there are still serious questions to be answered regarding how principles will be translated into the design and operations of the new Investigation Branch.
3The Department of Health must also be very conscious of the limits of what HSIB...
Concluded (the committee's words)
The Department of Health must also be very conscious of the limits of what HSIB can achieve with a limited budget and a remit to investigate only 30 cases per year. In this respect it is crucial that HSIB is not only an exemplar of high quality clinical investigations but is also focused on setting national standards and ensuring improvements at a local level - where the vast majority of clinical investigations will continue to take place - is not neglected.
4We are pleased that the EAG agrees with the Committee on HSIB’s role and remit.
Concluded (the committee's words)
We are pleased that the EAG agrees with the Committee on HSIB’s role and remit. Government must now take strong action to show that it is serious about turning the new Investigation Branch into a body of real authority and professional capability.
5PASC made clear that HSIB must be independent, and the Secretary of State for Health...
Concluded (the committee's words)
PASC made clear that HSIB must be independent, and the Secretary of State for Health appeared to have accepted this recommendation. Therefore the Government’s decision to locate HSIB within NHS Improvement, instead of making it directly accountable to the Secretary of State, is both disappointing and unacceptable. This appears to be solely to comply with the Government’s general stricture against forming new public bodies, or because Departmental spending is subject to cuts, whilst NHS spending is not.
6HSIB should be part of the Department of Health, rather than part of the NHS,...
Concluded (the committee's words)
HSIB should be part of the Department of Health, rather than part of the NHS, the organisation which it is being created to investigate. It is the Secretary of State who is ultimately accountable to Parliament for the safety of the NHS in England, not NHS Improvement. Furthermore it is the Secretary of State who is responsible for setting up a public inquiry, should this prove necessary. Therefore, like its parallel bodies who conduct aviation, marine and rail accident investigations, HSIB should report directly to the Secretary of State.
7However, we agree that Parliament can and should provide additional safeguards and direct oversight so...
Concluded (the committee's words)
However, we agree that Parliament can and should provide additional safeguards and direct oversight so that the Secretary of State is not exposed to any suspicion of untoward ministerial influence. We therefore reiterate the recommendation that there should be primary legislation to provide that HSIB shall be established as a separate body, independent from the rest of the NHS, in order that it can conduct - and be seen to conduct - fully independent investigations. As part of NHS Improvement HSIB will be vulnerable to improper influence and is likely to find itself in the impossible position of having to include the body of which it is a part in its own investigations. We cannot accept the decision to dilute a core principle of the new Investigation Branch, and believe that there is a clear consensus across the sector that the proposed arrangements are an intolerable compromise.
8The Government must commit in its response to this Report to bringing forward the necessary...
Recommended (the committee's words)
The Government must commit in its response to this Report to bringing forward the necessary primary legislation to secure HSIB’s independence as soon as possible. If the Government does not do so then the Committee will call the Secretary of State for Health to give evidence to account for this failure.
9The first Chief Investigator of HSIB will have considerable responsibilities for establishing the new body,...
Concluded (the committee's words)
The first Chief Investigator of HSIB will have considerable responsibilities for establishing the new body, including the developing and publishing of Investigation Principles and creating and sustaining the much discussed ‘safe space’. It is essential that the successful candidate is of the highest calibre and commands public confidence. As the Chief Investigator will play a key role in protecting and safeguarding the public’s rights and interests, it is also vital for the reputation and credibility of HSIB that the post holder is, and is seen to be, independent of Ministers and Government. We are unconvinced by the external commitments that have been made to the Chief Investigator’s independence, and do not believe that the new appointee being made directly accountable to the Secretary of State can be said “to provide an additional foundation for his or her independence.” Therefore we believe that a pre-appointment hearing would strengthen public confidence in the new body.
10We regard the ‘safe space’ principle as being critical to the effective operation of HSIB.
Concluded (the committee's words)
We regard the ‘safe space’ principle as being critical to the effective operation of HSIB. This protection is essential if patients and staff are to have the confidence to speak about the most serious risks to patient safety without fear of punitive reprisals. Its importance is underlined by the work of the Air Accidents Investigation Branch on which HSIB is modelled. In the Committee’s view, the only way to effectively establish this ‘safe space’ is for the Government to bring forward primary legislation that will guarantee its inviolability. The EAG’s final report also agreed that the ‘safe space’ must be given a “legislative base” in order to be effective. We will regard 32 PHSO review: Quality of NHS complaints investigations anything else as a failure to implement PASC’s original recommendation and evidence of a disregard for the consensus position of both healthcare experts and Parliament.
11The Government must also spell out how protocols between HSIB and other regulatory and investigatory...
Recommended (the committee's words)
The Government must also spell out how protocols between HSIB and other regulatory and investigatory bodies will strike the right balance between respecting the ‘safe space’ principle and HSIB’s competing obligation to share information in certain, specified circumstances (such as following a court order). In particular, the ‘safe space’ must be protected from Freedom of Information requests, as are the similar bodies responsible for air, marine and rail accident investigations.
12HSIB should assume unambiguous responsibility for setting the national standards by which all clinical investigations...
Concluded (the committee's words)
HSIB should assume unambiguous responsibility for setting the national standards by which all clinical investigations are conducted. It should remain the responsibility of local NHS providers to deliver on these standards, according to the Serious Incident Framework. The Care Quality Commission should continue to fulfil its role as the regulator in assessing the quality of clinical investigations at a local level. These distinct functions must be clearly explained to patients to ensure that confusion does not persist.
13HSIB, and in particular, the Chief Investigator, should develop a strong relationship with professional regulators...
Concluded (the committee's words)
HSIB, and in particular, the Chief Investigator, should develop a strong relationship with professional regulators to ensure that the Investigation Branch’s recommendations are acted upon by providers. In addition, HSIB should be empowered to suggest changes to national regulatory standards where this will result in systemic improvements to patient safety.
14It is undeniably important that NHS Improvement assist Trusts in implementing recommendations made by HSIB...
Concluded (the committee's words)
It is undeniably important that NHS Improvement assist Trusts in implementing recommendations made by HSIB or by the CQC, but this alone cannot deliver the necessary improvements to patient safety across the NHS in England. Given its own limited capacity, HSIB as the national clinical investigations function and exemplar of good practice, must work closely with NHS organisations to build a highly- trained and professionalised cadre of local investigators, who are respected by other healthcare professionals and trusted by the public. These local investigators should be capable of examining those serious patient safety incidents not investigated by HSIB and helping NHS Trusts to learn the right lessons from their reports. If HSIB fails to provide national leadership in improving the quality of clinical investigations then it will not only be failing one of its primary objectives, but it will also be failing the public.
15The Committee welcomes the Minister for Care Quality’s admission that more work must be done...
Recommended (the committee's words)
The Committee welcomes the Minister for Care Quality’s admission that more work must be done to fully implement the statutory Duty of Candour. We urge the Department of Health to press ahead with training staff across all NHS organisations in applying this principle. There must be a greater focus across the system on dealing with patients and their families and carers with compassion and respect when their case is the subject of a clinical investigation. HSIB must embody PHSO review: Quality of NHS complaints investigations 33 this in its own investigations, but responsibility for delivering this change across the whole healthcare system sits with NHS Improvement and NHS England more widely.
16The Government should be commended for adopting the “whole system approach” first recommended by PASC...
Recommended (the committee's words)
The Government should be commended for adopting the “whole system approach” first recommended by PASC in March 2015. The steps that have been taken to date are positive, although the Committee will continue to monitor their implementation and efficacy. However, we still have reservations regarding the Government’s ability to draw the results of these changes together and deliver a co-ordinated programme of improvements to patient safety on the ground. The Department of Health and NHS England must now focus their efforts on developing this feedback mechanism, to ensure that lessons learnt about the most serious patient risks are always acted upon.
17The Committee endorses the creation of a Just Culture Task Force as a positive step...
Concluded (the committee's words)
The Committee endorses the creation of a Just Culture Task Force as a positive step towards delivering “improvement, accountability and justice” across the healthcare system as a whole.
18We also support the EAG’s proposal for the re-opening of historic “unresolved grievances”, but only...
Concluded (the committee's words)
We also support the EAG’s proposal for the re-opening of historic “unresolved grievances”, but only where there is a clear argument that doing so would assist in improving patient safety in the future, or where serious outstanding legitimate grievances persist. This process might take the form of a single public inquiry, to consider which legacy cases to review, to hear the selected cases, and make recommendations arising from them. This should be seen in the context of other wide-reaching inquiries in recent years, such as the public inquiry into historic child sexual abuse, the Hillsborough Independent Panel’s inquiry into the Hillsborough disaster, and the Saville inquiry into the events of Bloody Sunday. The purpose of this single public inquiry would be to provide closure to those affected by patient safety incidents, which cannot otherwise be obtained.
19The Committee acknowledges the concern expressed by some witnesses regarding the specific findings and recommendations...
Concluded (the committee's words)
The Committee acknowledges the concern expressed by some witnesses regarding the specific findings and recommendations for complaints handling in the PHSO report. PASC addressed the question of Ombudsman reform during the last Parliament. PACAC now expects the Government soon to respond further to the PASC recommendations with the necessary legislation to create the Public Service Ombudsman.
20The Committee welcomes the programme of work to improve NHS complaints handling commissioned by the...
Concluded (the committee's words)
The Committee welcomes the programme of work to improve NHS complaints handling commissioned by the Department of Health and NHS England. However, we believe that there is still a long way to go to deliver a credible and uniform NHS complaints process that the public can trust and rely on. We expect the Minister for Care Quality to honour his commitment to finish the job and will not hesitate to call him before the Committee again to explain future policy developments.

Evidence

Oral evidence sessions 1

Correspondence 1 letter