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Care Quality Commission Third party review of CQC’s regulatory approach Final report
23 January 2013
This final report has been prepared for the Audit, Risk and Assurance Committee at the Care Quality Commission. No party, other than the Care
Quality Commission is entitled to rely on the Final Report for any purpose whatsoever and we accept no responsibility or liability to any other
party in respect of the contents of this Final Report.
© 2013 Deloitte LLP
The Audit, Risk and Assurance Committee Care Quality Commission Finsbury Tower 103 - 105 Bunhill Row London EC1Y 8TG 23 January 2013
Dear Sirs,
Third party review of the Care Quality Commission’s regulatory
approach
In accordance with the terms of the purchase order dated 10 September
2012 (the ‘Contract’), for the third party review of the regulatory approach
at the Care Quality Commission (‘CQC’), we enclose our final report dated
23 January 2012 (the ‘Final Report’).
The Final Report has been prepared for the sole use of the CQC and is
subject to the restrictions on use specified in the Contract. No party, other
than the Care Quality Commission is entitled to rely on the Final Report for
any purpose whatsoever and we accept no responsibility or liability to any
other party in respect of the contents of this Final Report.
The Final Report must not, save as expressly provided for in the Contract
be recited or referred to in any document, or copied or made available (in
whole or in part) to any other person.
The Audit, Risk and Assurance Committee is responsible for determining
whether the scope of our work is sufficient for its purposes and we make
no representation regarding the sufficiency of these procedures for CQCs
purposes. If we were to perform additional procedures, other matters
might come to our attention that would be reported to CQC.
We have assumed that the information provided to us and management's
representations are complete, accurate and reliable; we have not
independently audited, verified or confirmed their accuracy,
completeness or reliability. In particular, no detailed testing regarding the
accuracy of the financial information has been performed.
The matters raised in this report are only those that came to our attention
during the course of our work and are not necessarily a comprehensive
statement of all the strengths or weaknesses that may exist or all
improvements that might be made. Any recommendations for
improvements should be assessed by CQC for their full impact before
they are implemented.
Yours faithfully
Deloitte LLP
Deloitte LLP
2 Hardman Street
Manchester
M3 3HF
Tel: +44 (0) 161 832 3555
www.deloitte.co.uk
Deloitte LLP is a limited liability partnership registered in England and Wales with registered number OC303675 and its registered office at 2 New Street Square, London EC4A 3BZ, United Kingdom. Deloitte LLP is the United Kingdom member firm of Deloitte Touche Tohmatsu Limited (‘DTTL’), a UK private company limited by guarantee, whose member firms are legally separate and independent entities. Please see www.deloitte.co.uk\about for a detailed description of the legal structure of DTT L and its member firms.
© 2013 Deloitte LLP 2 Care Quality Commission Third party review of CQC regulatory approach
3
Contacts and contents
The contacts at Deloitte in
connection with this report are:
Steve Bundred
Lead reviewer
Dr. Jay Bevington
Partner
Nicky Cooke
Director
Page
Introduction and scope 4
Executive Summary 7
Findings and commentary 11
Recommendations 36
Appendix 1: Terms of Reference 40
Appendix 2: Section 48 of the Health & Social Care Act 2008 43
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Introduction and scope
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Introduction and scope
Project scope
This report sets out the findings of our independent review of the
Care Quality Commission’s (‘CQC’) use of its investigation powers as
set out in Section 48 of the Health and Social Care Act 2008 in
relation to NHS Hospital Trusts and Foundation Trusts to provide
assurance to the Audit, Risk and Assurance Committee (‘ARAC’) of:
• the reasonableness and proportionality of CQC’s regulatory
activity using investigatory powers (and the procedures
underpinning those) using the cases noted as studies;
• the adequacy and proportionality of the use of investigation
powers; and
• where appropriate, to make recommendations regarding areas
for improvement.
The detailed terms of reference are included in Appendix 1 and the
scope is in line with the Purchase Order dated 10 September 2012.
Our review focused on three case study acute hospital trusts:
Barking, Havering and Redbridge University Hospitals NHS Trust
(‘BHRT’); University Hospitals Morecambe Bay NHS Foundation
Trust (‘UHMB’) and Basildon and Thurrock University Hospitals NHS
Foundation Trust (‘BTT’). CQC had undertaken an investigation at
both BHRT and UHMB, but although there had been a history of
regulatory concern at BTT the S.48 power had not been used. UHMB
and BTT are NHS Foundation Trusts and hence are also subject to
regulatory powers conferred upon Monitor.
We would like to thank CQC Board members, staff, and external
stakeholders for their engagement during this project.
Our approach
Our approach to delivering the project scope has consisted of:
1. Reviewing documentation which included:
• The results of compliance reviews, inspections and
investigations undertaken between April 2010 to
August 2012 for each Trust;
• CQC Judgement Framework;
• CQC Guidance about Compliance;
• CQC enforcement policy;
• Chronologies for each Trust prepared by CQC; and
• Relevant internal policies and Board and
management team minutes; and
• Other relevant information, including risk summit
minutes.
2. Conducting semi-structured interviews with key CQC
personnel;
3. Conducting semi-structured interviews with representatives
from the 2 of the Trusts;
4. Conducting semi-structured interviews with external
stakeholders including relevant SHAs, other healthcare
regulators including Monitor;
5. Analysing and evaluating the evidence;
6. Undertaking a feedback session with the ARAC on 30
November 2012 and Board on 12 December 2012. The
purpose of these sessions was to provide verbal preliminary
feedback on the results of our work; and
7. Designing and facilitating a 2hr workshop with the key
senior internal stakeholders in the CQC regulatory process
to discuss the key issues identified by our review and to test
and work through sensible, realistic and pragmatic actions in
response to recommendations made. This will take place in
early 2013.
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Introduction │Executive Summary │ Findings │ Recommendations │Appendices
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Introduction (continued)
Introduction │Executive Summary │ Findings │ Recommendations │Appendices
Glossary of terms used throughout this report
CQC = The Care Quality Commission
BHRT = Barking, Havering and Redbridge University
Hospitals NHS Trust
UHMB = University Hospitals Morecambe Bay NHS
Foundation Trust
BTT = Basildon and Thurrock University Hospitals NHS
Foundation Trust
SHA = Strategic Health Authority
NPA = National Professional Advisors
HCC = The Healthcare Commission
S.48 = Section 48 of the Health & Social Care Act 2008
S.52 = Section 52 of the National Health Service Act 2006
SUIs = Serious Untoward Incidents
Structure of the report
Our detailed findings in respect of all these matters are set out below
under the following headings:
• Board oversight of regulatory activity;
• Preliminary decision making;
• Resourcing, methodology and conduct of the investigations;
• Reporting and impact of the investigations;
• Liaison with other stakeholders;
• Other issues.
Our findings comprise a description of what we found in relation to
each area along with an series of recommendations. A summary
statement is provided within the Executive Summary.
The findings have been mapped against the terms of reference in
Appendix 1.
Next steps
We recommend that CQC should create an Action Plan that
incorporates how CQC proposes to implement the various
recommendations detailed in this report, by when and how the Board
will monitor progress.
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Executive Summary
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Executive Summary
CQC was established in October 2008 and became operationally
active on 1 April 2009, when it merged with and replaced the
regulatory functions of the previous three regulators: the Healthcare
Commission; the Commission for Social Care Inspection; and the
Mental Heath Act Commission.
Section 48 of the Health & Social Care Act 2008 gives CQC a useful
and potentially very powerful strategic regulatory tool. CQC has
undertaken four investigations under S.48 of the 2008 Act, since NHS
providers were first registered on 1 April 2010, and has learned
rapidly from its experience. Therefore it has already taken many of the
actions we might otherwise have suggested based on our review of
the two case study investigations. However, there are further
improvements which can be made and CQC has not yet made use of
this tool to its best effect. We set out below our key findings and
recommendations.
Decision to investigate
In both cases where investigations have occurred the decisions to
investigate were properly authorised and can clearly be justified by
reference to criteria set out in the CQC Enforcement Policy applicable
at the time. They are also justified by the current Enforcement Policy
which differs in important respects. The new policy is a significant
improvement on its predecessor, but the criteria set out in both
polices are transparent and appropriate.
However, in neither case was an investigation strictly necessary. The
decision to investigate appears in both cases to have been prompted
more by frustration of the slow pace of improvement at the trust
concerned and the pressure of external events rather than any careful
consideration of what purpose an investigation might serve. As such,
we do not consider these decisions to represent examples of good
regulatory decision making.
We would advise that there should be stronger and clearer oversight
by the CQC Board of strategically significant regulatory decisions of
this kind. This would have the added advantage of ensuring that the
reasons for the decisions are fully documented and the decisions
properly recorded.
In the case of BTT, the decision not to launch an investigation was in
our view correct, and remains so, although an investigation could
nevertheless have been justified on the basis of the criteria applied
to such decisions at several points. BTT is an example of the
importance of allowing maximum flexibility for the exercise of
judgement within a transparent regulatory framework and the CQC
framework provides for this.
The key decision in respect of BTT rested on the fact that Monitor
has powers CQC does not possess. CQC has argued for additional
powers in its evidence to the Francis Inquiry and we believe these
are needed. However, we also believe that CQC could make more
creative use of the powers it currently has.
Resourcing of the investigations
The investigations were adequately resourced and the teams were
led by competent and experienced inspectors who were able to draw
on expert external and internal advice as required. The inspection
teams were large and in both cases included clinicians and a chief
executive. We regard all of this as good practice. We nevertheless
consider that it would have been better if all members of the team
had been present throughout the whole of the two investigations. It
would also represent better financial management if a budget for the
investigations had been determined in advance.
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Executive Summary (continued)
Methodology and reporting
The teams should have been given more time to allow them to
prepare for the investigations. They should have been more
thoroughly and formally briefed as to the purpose of the investigations
and the distinction between investigations and normal compliance
reviews. Also more thought should have been given to the terms of
reference and methodology adopted with this distinction in mind. As it
was, the investigations were undertaken and reported in a way which
was too similar to normal compliance reviews. In their own terms,
they were well conducted and served a useful purpose, but they
revealed very little about the two trusts that was not already known.
The results were therefore sub-optimal. The perceived benefits also
came at a high cost to the trusts themselves.
In particular, in order to get behind the concerns that are likely to
prompt an investigation and ensure that wider systemic, governance,
leadership and cultural issues are adequately addressed, CQC needs
to go beyond the outcome standards used for compliance reviews in
approaching both the conduct and the reporting of investigations. We
understand that in future investigation reports will be more clearly
referenced to the original Terms of Reference. We applaud this. We
also consider that it would be more helpful if recommendations
contained in investigation reports were fewer in number, more clearly
focused on the key issues and prioritised wherever possible.
9
In order to conduct effective investigations which address wider
systemic issues or worries about leadership, governance and
culture, CQC needs to develop appropriate methodologies which
would provide guidance to staff undertaking investigations of this
kind. In particular, CQC needs to be able to articulate a view about
how to drive improvement in an acute hospital trust where
leadership, governance and cultural issues are at the core of its
concerns.
We believe that CQC needs to understand and articulate at all levels
that S.48 of the 2008 Act confers upon it a very broad and strategic
power. We are not persuaded that the new Framework for
Investigations and the Decision to Investigate guidance fully reflect
this, but both represent a significant advance.
We do not have any concerns about the judgements expressed in
the investigation reports concerning the services provided to
patients, which were accepted as valid by the trusts. We
nevertheless consider that the Quality Assurance arrangements for
reports of this kind could usefully be strengthened.
We consider that CQC could usefully adopt the practice of other
regulators in making known its concerns about a regulated body. In
particular, we believe it should consider engaging more directly with
boards.
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Executive Summary (continued)
Other issues
We have felt it necessary to comment in this report on a small number
of matters that arose during the course of our review which were
beyond our terms of reference. The matters we have felt it appropriate
to include in our report are as follows:
• CQC should give careful thought to how it engages with local
authorities, given their new powers and responsibilities in relation
to health;
• We consider that CQC should question its generic approach to
inspection;
• CQC could benefit from having greater clarity about the role of its
National Professional Advisors; and
• more attention needs to be paid by CQC to downward and
horizontal communication with its staff.
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Findings and commentary
© 2013 Deloitte LLP 11 Care Quality Commission Third party review of CQC regulatory approach
Findings and commentary
Summary of
contents 1. Board oversight of regulatory activity 13
2. Decision to investigate 15
3. Resourcing, methodology and conduct of the investigations 21
4. Reporting and impact of the investigations 27
5. Liaison with other stakeholders 32
6. Other issues 34
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1. Board oversight of regulatory activity
1.1. Strategic versus operational power:
The use of Section 48 powers have been considered an operational matter within CQC, but the powers are strategic
in nature.
The CQC Board delegates all regulatory decisions to the Chief Executive so that it can hold the
Chief Executive and the Executive team to account for delivering CQC’s strategic aims and
objectives. This reflects a proper understanding of the distinction between strategic and operational
roles and of the clear responsibility of the Board for strategic leadership and decision making.
However, we would comment that some regulatory decisions may be strategic as well as
operational; and we consider that a decision to exercise the S.48 powers falls within this category.
There are no widely recognised criteria determining what constitutes a strategic regulatory decision.
It is a matter for judgement, but we would suggest that among the tests to be applied are:
• whether the decision would commit a significant amount of the organisation’s resources and
involve a level of activity not envisaged in the originally approved budget, which might thereby
impact on other planned activity;
• whether the decision would require the exercise of novel or unusual powers and hence involve a
greater than usual risk of poor judgement or decision making;
• whether the decision might lead the regulator into commenting on the actions (or inactions) of
bodies it does not regulate (such as the SHA or commissioners) and hence impose a risk of
damage to relationships with key stakeholders; and
• whether the decision would attract a high level of media and/or political interest, and hence
involve a more than usual degree of risk to reputational damage.
Satisfying any of these tests would in our view make it more likely than not that the decision should
be regarded as strategic and it appears to us that the exercise of the S.48 powers satisfies all of
them.
.
Deloitte commentary:
We note that CQC have delegated
the decision to conduct an
investigation under S.48 to the
Chief Executive on this basis that
this is an operational matter.
We would question this premise as
we consider the decision to
exercise S.48 powers to be a
strategic regulatory decision.
We consider that both the Board
and senior management of CQC
need to exercise stronger oversight
of strategic regulatory decision
making and that there should be
better and fuller recording of
strategic regulatory decisions.
13
* Recommendations are highlighted in bold. In addition, actions agreed at the workshop are included in this section.
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1. Board oversight of regulatory activity
1.1. Strategic versus operational power (continued):
The Board at CQC were informed, but not involved in the decision to exercise S.48 powers in line with the Scheme of
Delegation
We have considered possible arguments which might be advanced in opposition to this conclusion
(although it is worth noting that no such arguments have been put to us by CQC staff). In particular
we are mindful of the importance that regulators rightly attach to the reality and the perception of
their independence, both from the bodies they regulate and from the possibility of political influence.
We have observed that the latter is secured within CQC by substantial delegation of regulatory
powers. In principle, a high level of delegation is good practice, but we would question whether there
is adequate oversight by Board members and senior management of the exercise of delegated
functions. CQC staff do not exercise their powers in a personal capacity. Unlike doctors, police
officers or some other professionals, they are not personally liable for their actions. The regulator of
the quality of health and social care provision is CQC itself, operating through its Board which is
appointed by and accountable to the Secretary of State. All the regulatory functions are therefore
vested in the Board and delegated by it to CQC officers only to the extent that the Board considers
appropriate, which may change over time or vary in relation to particular issues.
Although the CQC Board was informed by the Chief Executive of the decision to initiate
investigations soon after the decisions were taken, there was no prior discussion with the Board
about the likelihood of such actions or their possible implications. There was also no subsequent
detailed discussion by the Board of the investigation reports and the wider lessons to be learned
from them, although such discussion did take place within CQC’s management. As these decisions
were clearly matters for the Chief Executive, under the Scheme of Delegation, there was no breach
of procedure in this respect; however we would observe that within other regulators of which we
have knowledge and experience there would be stronger and clearer oversight by the Board of
decisions of this kind. Indeed, it is unusual that the CQC Board has not reserved to itself a decision
to exercise the powers given to it under S.48 of the 2008 Act.
Deloitte recommendations:
1. The Board should identify
those regulatory matters it
considers to be strategic.
2. Decisions relating to these
powers should be reserved to
the Board.
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2. Decision to investigate
2.1. Evidence and propriety of decision to investigate :
In line with the Scheme of Delegation the Chief Executive, on advice from the Director of Operations, made the
decision to investigate at the two case study trusts. This advice was not documented.
The current CQC Scheme of Delegation, dated March 2012, clearly delegates to the Chief Executive
(Annex 1, page 40, paragraph 45) the decision to order an investigation under S.48 of the Health
and Social Care Act 2008 “after receiving advice from the Director of Operations, Deputy Directors
of Operations or Heads of Regional Compliance”.
We have been advised that its predecessor(s) documents contained identical, or essentially the
same, provisions and we are satisfied that the two investigations we have focused on were properly
authorised by the then Chief Executive in accordance with these arrangements. We have also been
assured that the Chief Executive had at no time prior to our review been advised by the Director of
Operations, or others referred to in the Scheme of Delegation, to initiate an investigation at BTT,
although active thought had on occasion been given to this possibility by the relevant CQC staff.
However, we have been unable to examine the detailed advice that was received by the Chief
Executive at the time the two investigations were decided upon, although we have seen an e-mail in
relation to UHMB, which recommends the Chief Executive authorises an investigation. The detailed
advice, which lays out the reasons for the investigation does not appear to have been given in
writing, or if it was, this cannot now be recalled by those involved and no record of it can now be
traced by the CQC staff who have been supporting us in this review.
In consequence, the reasons for conducting an investigation in the two cases we have looked at,
and in the case of BHRT the issues which the investigation was intended to shed light on, can now
only be inferred from the memory of those involved, the approved terms of reference and the
previous history of compliance activity at the two trusts.
We would comment that if the Board were to withhold the decision to investigate as discussed in
section 1, some of the issues we raise above would also be addressed. There would be a paper to
the Board setting out the reasons for the recommendation and a minute of the Board discussion
recording the reasons for its decision. This would then also enable the reasons for the decision to be
clearly matched to the terms of reference of the investigation and to the investigation report.
Deloitte commentary:
We consider it would be preferable
for there to be a clear written record
of the reasons for a
recommendation to investigate and,
if different, the reasons for its
acceptance. While providing better
protection for all those involved in
the decision making process, and
for the reputation of CQC itself, this
would have the added advantage of
ensuring a clear audit trail between
the reasons for the decision, the
approved terms of reference and
the substance of the investigation
report
Recommendation:
3. The decision to carry out an
investigation under S.48,
together with the reasons for the
recommendation should be
made in writing. The final basis
of the decision should be clearly
documented and both should be
retained.
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2. Decision to investigate
2.2. Criteria for an investigation
The Enforcement policy which includes the criteria for an investigation was updated in April 2012. We consider this
version to be an improvement to its predecessor as it more clearly reflects the strategic nature of the S.48 powers.
The terms of reference for the two investigations refer to them as satisfying the criteria for an
investigation set out in Appendix A of the CQC Enforcement Policy. This is the Enforcement Policy
dated October 2010 which was applicable at the time. The current Enforcement Policy, dated April
2012, sets out the criteria for an investigation in Section 5 and Appendix D. Although the provisions
of the two documents are similar in some respects, there are important differences in the wording
and we have therefore tested the decision making not just against the rules that were in force at the
time but also against those that currently apply.
We consider that the later version of the policy is a significant improvement on its predecessor in
that the criteria are expressed with greater clarity and are more in keeping with the apparent intent of
the 2008 Act that investigations should look more widely than routine compliance activity. The
provisions contained within the earlier document nevertheless appear to be appropriate having been
adopted as the criteria used by the predecessor body, the Healthcare Commission.
Both give CQC a wide degree of discretion, recognising that the circumstances will differ in each
case and apparently similar circumstances may nevertheless warrant different judgements about the
value of an investigation. The current Enforcement Policy states that an investigation is appropriate
when “one or more of the following criteria are met:
• Providers have failed to respond to conventional enforcement activity with the required
improvements in a reasonable timescale.
• Further enforcement activity will result in adverse consequences for people using services, for
example as a result of geographical isolation.
• There are indications that there are capacity issues either within the provider itself or across the
local care system, which impede the required improvements.
• We become aware of evidence of a significant problem affecting a whole local care system.
• Local commissioning and performance management authorities are not effectively supporting the
required improvements in terms of leadership, skills and expertise.
• Broader systemic failures which lie outside the remit of our routine inspection and enforcement
powers.”
Deloitte commentary:
We have examined the extent to
which the decisions taken satisfied
the criteria set out in the
Enforcement Policy dated October
2010 and October 2012 and have
concluded that in both the case
study investigations they did or
would have done so.
We have also concluded that a
decision to launch an investigation
at BTT could have been defended
at various points in time by
reference to the approved criteria,
including the currently approved
criteria, although given the
appropriately wide degree of
discretion accorded to CQC, at no
point would an investigation have
been required at any of the three
trusts.
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2. Decision to investigate
2.2. Criteria for an investigation (continued)
The emphasis of these criteria and of the provisions of S.48 itself is that the investigation power is
intended to permit CQC to examine systemic failings, including failings in bodies it does not regulate,
and/or to get behind poor outcomes for patients at an individual provider to look at the governance,
leadership and cultural issues which may be contributing to these poor outcomes. It is a power
which enables CQC to conduct an investigation with a focus which goes beyond the outcome
standards which are at the core of normal compliance reviews. This is reinforced in the new
Framework for Investigations which has a section (pages 5-6) headed “Differences between
regulatory compliance work and an investigation”.
The provisions in Appendix A of the October 2010 Enforcement Policy were less strategic in their
focus. At the time the decisions were taken to launch an investigation into BHRT, and the later
decision to conduct an investigation at UHMB, the policy in force was that:
‘Factors which might trigger us to commence a formal investigation include:
• A higher number than anticipated of unexplained deaths.
• Serious injury or permanent unnecessary harm to people, whether physical, psychological or
emotional
• Events which put at risk public confidence in care provided, or in the NHS, independent sector or
adult social services generally.
• A pattern of adverse outcomes for people or other evidence of high-risk activity.
• A pattern of failures on the part of a service or services; or team or teams, or concerns about
them.
• Allegations of abuse, neglect or discrimination affecting people who use services, particularly
those less able to speak for themselves or defend their rights.’
The absence of documentation recording the reasons for the decisions to investigate has prompted
us to study the chronology of events in an attempt to match the timing of the decision to the
emergence of information satisfying the criteria above. The following section outlines the key
findings from our review in relation to decision to investigate or not at each of the case study trusts.
Deloitte commentary:
Although the two investigations
were properly authorised and
justifiable, the decision to
investigate appears in both cases to
have been prompted more by a
perceived need to be seen to be
taking action in response to
external events rather than any
careful consideration of what
purpose an investigation might
serve. As such, we do not consider
these decisions to represent
examples of good regulatory
decision making.
We consider some of the alternative
actions that CQC could have
considered to achieve the
objectives of the investigations
based on our experience of working
with other regulators in Section 4.2.
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2. Decision to investigate
2.3. Our review of the decision to investigate for each case study
The issues at BHRT met the CQC criteria to investigate at the point the investigation was announced, however the
timing of the decision to investigate appears to have been heavily influenced by external pressures:
In the case of BHRT there had been a long history of concern about the trust dating back to before the creation of CQC. It was
registered in April 2010 with eight conditions. On 24 February 2011, CQC issued four Warning Notices following an inspection at
Queen’s Hospital in January 2011 which was assessing progress against the registration conditions. Further inspections were
undertaken at both Queen’s and King George Hospitals in late March and early April of 2011 to assess compliance with these notices.
The reports of these inspections were published in July 2011. They noted improvement in some areas and deterioration in others, which
resulted in a number of further compliance actions being imposed. But by this time the investigation was in progress.
The failure to detect more rapid improvement since the Warning Notices were issued was clearly a key element of the decision to
investigate. Nevertheless, it was also explained that the increasing level of publicity that BHRT was receiving was a factor in the
decision to commence a formal investigation, as this met one of the criteria in the 2010 Enforcement Policy: an “event which put at risk
public confidence in care provided, or in the NHS … generally”. For example, although not specifically cited by CQC staff, the House of
Commons adjournment debate secured by a prominent local MP, Margaret Hodge, on 22 June 2011, attracted considerable local and
national publicity.
Although the investigation at BHRT was primarily prompted by understandable frustration within CQC at the slow pace of improvement
in relation to the concerns there had been about the trust for several years, the timing of the decision appears to have been heavily
influenced by these external pressures.
This view is reinforced by the fact that as a result of the history of concerns the Strategic Health Authority, NHS London, had
orchestrated the appointment of a new, experienced Chief Executive in February 2011; the same month the Warning Notices were
issued. She took the Warning Notices very seriously, despite concerns among some of her staff that they overstated the problems.
Therefore, at the point the investigation was announced an action plan for improvement had already been devised and was in the
process of being implemented.
We understand that within the SHA there was a feeling that the new Chief Executive should have been given time to make the changes
necessary to effect improvement rather than being distracted by an investigation at such an early point in her tenure. This would have
been a reasonable view for CQC to take also. It is a judgement of the kind that all regulators are commonly called upon to make and it is
a view that CQC has in fact taken at another trust facing similar challenges. But CQC did not feel able to take this view about BHRT in
the circumstances prevailing in June 2011.
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2. Decision to investigate
2.3. Our review of decision to investigate for each case study (continued)
The investigation into UHMB satisfied the criteria set out in the Enforcement Policy applicable at the time and was
justifiable. However, the decision to investigate appears to have been more a reaction to events than part of a
considered strategy to secure improvement for patients; and there may have been an earlier missed opportunity.
UHMB was registered by CQC in April 2010 without conditions and was authorised by Monitor as a Foundation Trust in October 2010.
Although there had been previous concerns about the Trust including 12 Serious Untoward Incidents (‘SUIs’) over two years, five of them
relating to maternity services, it was believed at the time that the underlying issues had been addressed. But during 2011 it became
apparent from several sources, including a coroner’s letter to CQC arising from a child death and the discovery that the Trust had withheld
relevant information from regulators during the registration and FT authorisation processes, that serious problems persisted. This was
confirmed by a compliance review which reported in September and resulted in a Warning Notice being issued to the Trust.
As a result, in October 2011, UHMB was declared by Monitor to be in significant breach of its terms of authorisation as an NHS
Foundation Trust. Monitor then commissioned or instructed the Trust to commission: a peer review of maternity services from clinicians at
the Central Manchester University Hospitals NHS Foundation Trust; a review of governance, including clinical governance; and a further
report which related to a significant backlog in outpatient follow-up appointments. These became available to Monitor in December 2011
and confirmed that the problems at the Trust were more deep-seated than the concerns about maternity services that had originally
prompted intervention. When shared with the Trust they caused the resignation of the Chairman. CQC was informed of this on 13
December 2011 and immediately decided to launch an investigation.
On 6 February 2012, the day the investigation began, Monitor intervened at UHMB, using powers granted to it under section 52 of the
National Health Service Act 2006. It removed the Acting Interim Chair of the Board and appointed Sir David Henshaw as Chair to drive the
recovery of the trust; it required the trust to appoint a Turnaround Director and to create a Programme Management Office to support the
director; and appoint a Chief Operating Officer, acceptable to Monitor, to run the day to day activities of the trust across all of its sites. In
the light of this it is not clear to us what the investigation was intended to add, although we are satisfied that the investigation team took
pains not to duplicate the work of the reviews commissioned by Monitor. We also accept that the focus of the CQC investigation was on
outcomes for patients whereas Monitor’s focus was on leadership and governance; however by December 2011 it was already well
known that outcomes for patients at UHMB were poor, which was why Monitor had taken action under its S.52 powers and CQC had
issued a Warning Notice. Indeed, CQC issued a further Warning Notice on 25 January 2012, arising from an inspection conducted at the
Royal Lancaster Hospital on 21 December 2011.
It is worth noting that Monitor also commissioned a review by KPMG of the decision to grant the trust FT status which found that the
issues of concern should have surfaced at the time the FT application was being considered. It is therefore possible that a CQC
investigation at a much earlier stage might have proved useful. Due to the short time period that CQC had been established, there had not
been sufficient compliance activity or associated enforcement action to justify an earlier investigation. CQC was aware of the SUIs in May
2009 and of the fact that UHMB was a statistical outlier in respect of complaints and mortality, so might have felt able to justify an earlier
investigation on these grounds, but this has to be considered in the context of the maturity of the organisation at that time.
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2. Decision to investigate
2.3. Our review of decision to investigate for each case study (continued)
A decision to launch an investigation at BTT could have been defended at various points in time by reference to
the approved criteria, although given the appropriately wide degree of discretion accorded to CQC, at no point
would an investigation have been required.
As part of our review, we have been made aware that there were at least two occasions on which an investigation at BTT might have
been justified by concerns about the quality of its services.
The first was prior to registration and has therefore not been considered here as it is outside our scope, but the second arose in June
2012 when the possibility of an investigation was actively considered by CQC staff and a judgement was made that this should not be
recommended. As a result of the concerns previously identified by the Healthcare Commission (‘HCC’) and a prosecution of the trust by
the Health and Safety Executive following a legionella outbreak, the trust had been registered in March of 2010 with five conditions and
these had been followed up by compliance reviews in May and July of that year which had identified moderate concerns and resulted in
compliance actions being imposed. Arising from concerns about SUIs a fuller reactive review of Basildon Hospital was conducted in
September 2010 which identified major concerns in two areas. Over the course of the next year and a half, during which time a further
seven inspections took place, a pattern then developed of problems emerging in one area which the trust took effective action to
address, only for identical or other problems to emerge elsewhere within the hospital. This had been the subject of several risk summits,
and meetings with the trust at a more senior level than that associated with normal compliance work, but the pattern had not been
broken.
By June of 2012 therefore, when a further inspection took place which resulted in a Warning Notice being issued the following month,
there was a real and well evidenced concern within CQC that improvements that had often been observed within the trust over many
months had not proved to be sustainable and the trust had at no time been fully compliant with all outcome standards. Compliance staff
and some professional advisers therefore considered that an investigation was called for. This advice was taken very seriously by the
Director of Operations but rejected because of the substantial involvement that Monitor already had in addressing the concerns at the
trust and the action it had already taken.
We consider that this judgement was, in all the circumstances, the right one to make, but we would not have been overly critical had it
gone the other way. It was made following a proper review of the position and reflected CQC’s recognition that Monitor was in the best
position to take action and had the most appropriate powers to do so. We have not examined whether the action actually taken by
Monitor was sufficiently swift and effective, but we note that there is now an almost entirely new leadership team, at both executive and
non-executive level, at BTT, in which the respective regulators appear to have a high degree of confidence. Although there are
continuing problems at the trust, sufficient still to satisfy some of the criteria for an investigation, there is a general view that it is now
moving in the right direction.
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3. Resourcing, methodology and conduct of the investigations
3.1. Resourcing the investigations
The investigations were resourced by experienced teams, who could draw on specialist internal and external
resources.
CQC took the decision to disband the national investigations team that existed within one of its
predecessor bodies, the HCC, and with it the methodology for such investigations adopted by HCC,
at an early stage in its life, although it did maintain the criteria to investigate within the 2010
Enforcement Policy. The decision was controversial internally at the time and remains so. We do
not question this decision, not least because we recognise that CQC began life with fewer resources
and more responsibilities than its predecessor bodies and therefore has to use its resources more
sparingly. However, a regional based approach with far fewer investigations than previously
undertaken by HCC had the effect of diluting the inherited experience and expertise. We understand
that HCC undertook fifteen investigations in the four year period from 2005 to 2009, whereas CQC
has undertaken only four in the three years from 2009 to 2012.
The investigation at United Lincolnshire Hospitals NHS Trust was the first within an acute hospital
setting that had been undertaken by the CQC and the investigation at BHRT commenced while the
United Lincolnshire investigation was still in progress. Neither had been envisaged at the time the
CQC budget and operational plans for 2011/12 were set and so prior to the decision to launch an
investigation at BHRT (the first of our two case study investigations) there is no evidence to support
that there had been adequate consideration as to how it should be resourced or conducted.
In consequence, there was no approved budget for either of our two case study investigations, but
equally there was no resource constraint. We understand that CQC has quantified the direct cost of
the investigation at BHRT as being £88,831. We have not audited this figure so cannot verify it, and
we note that it refers only to the direct cost rather than the full cost of the investigation. We consider
that it would represent better financial management if a budget for the investigations had been
determined in advance.
The real constraint was the expectation that the investigation team, at least in the case of BHRT,
would report no later than 16 weeks after the investigation had been announced. This was a tight
timescale but reflected the fact that the CQC approach to investigations was, in our view
appropriately, less intensive than that of HCC. The latter typically took between six and eight months
to complete, although we note that the UHMB investigation report was also published nearly six
months after the investigation began.
Deloitte commentary:
Within their own terms, and set
against the criteria applicable at the
time, the two investigations we
have looked at were well led by
highly competent CQC staff and
were conducted by teams made up
of experienced and suitably
qualified people. In both cases they
included people external to CQC
with clinical or senior administrative
experience in the NHS.
The short timescales imposed on
the investigation teams to
commence the site visit once the
investigation was announced had
consequences for the way in which
the investigations were conducted
both in relation to the resource
available and the methodology
used.
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3. Resourcing, methodology and conduct of the investigations
3.1. Resourcing the investigation (continued)
The tight timescale imposed on the investigation impacted on the resources available. For example,
in the case of BHRT it proved impossible to assemble a sufficiently senior investigation team who
could devote two full weeks (the length of the site visit) to the investigation. This meant that in the
first week there were 15 or 16 team members involved and in the second 8 or 10. There was some
overlap, but several of those engaged during the first week were not involved in the second, and vice
versa. Hence there was no clearly defined team that collectively shared and challenged the
evidence emerging from the investigation and took ownership of the final report. This approach
places an unusually high premium on the internal quality assurance arrangements within CQC and
the wisdom and judgement of the Compliance Manager responsible for leading the investigation
team.
There was also pressure for the team to get on site as quickly as possible at UHMB, but in this case,
although there were some team members who contributed only briefly, there was a core team
present throughout the whole period including expert external advisers. The team at UHMB
comprised 13 or 14 people.
In both cases, there were daily briefings for the team on site each evening on the issues that had
arisen during the day and the report was shared in draft with some of the team members for their
comment, which included the external clinical advisors at BHRT. We consider that these should
broadly be the expected arrangements for any future investigation.
Overall we would conclude that within their own terms, and set against the criteria applicable at the
time, the two investigations we have looked at were well led by competent and experienced CQC
staff and were conducted by teams made up of experienced and suitably qualified people. In both
cases they included people external to CQC with clinical or senior administrative experience in the
NHS. The team leaders also had access to legal advice and communications experts. We comment
below on the impact of the investigations at the trusts concerned but we have heard no major
concerns about the composition of the investigation teams or the validity of the conclusions they
reached, and we have heard very positive comments about specific team members.
Deloitte recommendations:
4. Determine in advance a budget
for the investigation, which
includes both the direct costs of
the investigation, for example
expenses, fees to external
experts and the internal staff
costs.
5. Put in place a dedicated team
for each investigation, who are
involved across all stages of the
investigation. The team should
be involved in reviewing relevant
sections of the draft report.
6. The clinical and non clinical
external advisors should review
and comment on the findings
draft investigation reports.
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3. Resourcing, methodology and conduct of the investigations
3.2 Methodology
There was limited guidance available to the investigation teams at the time of the case study investigations. CQC
have subsequently made significant improvements in this area, but there are further improvements that can be
made.
At the time the two case study investigations took place, there was no investigation methodology in
place within CQC. The planning and design of the methodology was mainly left to the two lead
investigators with only limited central support. For example, whilst both had previous experience of
undertaking investigations as part of investigation teams within the predecessor regulators, they
were not provided with specific training in relation to the conduct of an investigation within CQC or
any formal briefing (albeit: they were both provided with some background information in relation to
the trust itself and they both arranged to speak to the relevant compliance teams). Further, the
timetables under which the two case study investigations were conducted provided no opportunity
for detailed consideration of the most appropriate methodology, and we have seen no evidence of
this matter being discussed within any governance forum or among the most senior staff of CQC.
Ultimately, as we were told by a number of different sources, this resulted in the investigation teams
having to develop the methodology themselves, although UHMB did draw upon the approach used
at BHRT. This does not invalidate the conclusions they reached in either case, but it did in practice
limit the scope of the investigations. In particular, it did not permit the investigations to be designed
in such a way as to clearly distinguish them from normal compliance reviews and to enable them to
address the criteria itemised in the Enforcement Policy as laid out in Section 2.2, although we accept
that they satisfied the criteria applicable at the time.
Our observation is that while both of the investigations we looked at served a useful purpose, their
utility would have been strengthened by a clearer initial view of what they were intended to achieve
and more thought being given to how best to identify and evidence the actions needed to address
these issues. For example, we have heard differing views of the extent to which the two
investigations were able to address underlying cultural issues within the relevant trusts, but from our
review of the information already available to CQC at the time each investigation was authorised,
and from our examination of the investigation reports themselves, our impression is that the
investigations did not tell CQC much that it did not already know and were not designed in a way
which would enable them to do so. We consider that more might have been achieved had the
investigations been framed with clearer regard to the issues itemised in the section of the new
Enforcement Framework for Investigations headed ‘Differences between regulatory compliance
work and an investigation’.
Deloitte commentary:
There was no investigation
methodology in place at the time
the two case study investigations
were undertaken.
The timetables that had been set to
be on site quickly once the
investigation was announced,
meant that there was limited
opportunity to develop a more
considered methodology which
would be able to address some of
the wider concerns at the trust. For
example, underlying cultural issues
or wider health economy concerns.
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3. Resourcing, methodology and conduct of the investigations
3.2 Methodology (continued)
For example, we note that the terms of reference of the investigation at BHRT did not require any
consideration of the financial difficulties faced by the trust and the extent to which this was impacting
on concerns about staffing, although there is mention in the report of the scale of the deficit being
part of the context. Further, in both cases the contribution to poor clinical practices played by poor
relations with commissioners was clearly an issue, and was touched upon in the report, but did not
feature strongly in the recommendations. Indeed it is not clear to us how this issue could have been
addressed in any depth without considerable thought being given beforehand to the criteria against
which the relationships would be judged.
Equally, it is apparent from our review that the pressure on maternity services at both BHRT and at
BTT needs to be seen in the context of substantial population growth and a rising birth rate affecting
hospitals throughout East London and Essex, but an investigation of these matters would require a
very different approach to the one adopted.
In respect of a number of the concerns we identified, CQC has already made significant advances
since the investigations were conducted, and has continued to do so since our review was
commissioned. Specifically:
• it has reviewed the criteria for launching an investigation, expressed these criteria in more
strategic terms, to match the apparent intention of the 2008 Act, and published them in a revised
version of its Enforcement Policy;
• it has convened meetings of those involved to consider the lessons learned;
• it has published a detailed handbook for staff titled “A framework for investigations”;
• it has supplemented this with a document for staff titled “Decision to investigate guidance”; and
• during the course of our review it has given close consideration to the possibility of an
investigation at BTT but has, for the time being at least, decided instead to adopt a different
approach which is in our view more likely to drive improvement for patients as quickly as possible
while in no way understating the degree of CQC’s concerns about the trust.
Deloitte commentary:
There has been significant
improvement in the guidance and
policy documents in relation to
investigations, since the 2 case
study investigations were carried
out. For example, CQC has
recently (September 2012) adopted
a new Framework for Investigations
which addresses some of the gaps
in previous arrangements which
have been evident from our review,
especially in relation to the
guidance available to staff.
However, the new guidance does
not contain what we would
recognise as a methodology for
conducting investigations aimed at
systemic or leadership and
governance issues.
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3. Resourcing, methodology and conduct of the investigations
3.2 Methodology (continued)
We have already commented that we regard the new Enforcement Policy as a significant
improvement on its predecessor. We also consider that the Framework for Investigations and the
Decision to Investigate guidance will prove helpful to staff. However, we have a concern about the
degree of consistency between these three documents and we would comment that none of them
contain what we would recognise as a methodology for conducting investigations aimed at systemic
or leadership and governance issues, along the lines of that set out in Part 2 of “Essential standards
of quality and safety”, CQC’s guidance about compliance.
The Decision to Investigate guidance could more usefully reflect the fact that an investigation might
not arise directly from compliance activity at a particular regulated body, but might result from issues
arising at a number of bodies. In the circumstances alluded to above, for example, it would be open
to CQC to investigate pressure on maternity services across the whole of a region or sub-region and
the likelihood of the supply of midwives matching future demand. In our view, both the new
Enforcement Policy and the Framework for Investigations are clearer in their recognition that the
S.48 power is very broad and permits CQC to undertake investigations that are not directly
connected to its enforcement activity. This understanding of the nature of the power needs to be
clearly expressed in all communications to staff.
Deloitte recommendations:
7. Develop a methodology/
toolkit which investigation teams
can draw upon when scoping
and planning an investigation. In
particular these should include
guidance on how to investigate
governance and leadership from
Board to Ward.
8. Further consider how CQC can
use the work from other
regulators and in relation to
Monitor look at the where the two
regulatory frameworks meet and
how the two can be dovetailed to
prevent duplication.
9. Ensure that staff understand
the strategic nature of the
investigation powers and the key
differences to a compliance
review.
10. Ensure all communication to
staff (all 3 policy documents)
clearly express the nature of the
S.48 power.
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3. Resourcing, methodology and conduct of the investigations
3.3 Quality Assurance processes
CQC did have a Quality Assurance process in place for the two investigations and whilst there were
no problems in these particular instances, we nevertheless consider that CQC could benefit from a
more rigorous approach to the quality assurance of reports of this kind.
As part of the internal process, the draft reports were initially reviewed by the Regional Director or in
the case of UHMB, the Head of Regulatory Risk and Quality. There was then a second review
undertaken by senior managers within CQC including the Director of Operations and the Head of
Regulatory Risk and Quality who were able to question the evidence base for some of the
judgements reached and to satisfy themselves that the degree of concern expressed was
proportionate in the context of other CQC interventions. The draft reports were also sent to the Trust
to check for factual accuracy.
All of this proved effective in ensuring that the reports were of generally a good quality, but the large
number of recommendations and their lack of a clear focus does not seem to have been questioned
through this approach.
If CQC is to undertake more complex investigations in the future we consider that there would be
value in adopting the practice of some other bodies with the draft reports being subject also to a
rigorous peer challenge from suitably experienced individuals unconnected with the investigation.
Deloitte recommendations:
11. For each investigation, as
part of the quality assurance
process, ensure the draft report
is reviewed and challenged by a
suitably experienced manager
who is independent of the
investigation.
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4. Reporting and impact of the investigations
4.1. Reporting
The reports grouped the findings by reference to the outcome standards, which limited the opportunity for a more
strategic narrative, which could explain the underlying causes of the issues at each Trust.
Many of our observations set out above on the methodology used for the two investigations arise
directly from our consideration of the way they were conducted and the reports were structured. The
two investigations we have looked at were conducted by reference to the outcome standards used
for compliance reviews and the reports and recommendations were grouped under these same
headings. This has a clear advantage in that the approach is familiar to CQC staff and did not
require any special training or preparation in advance of going on site, which was clearly important
given the tight timetable. However, this benefit is outweighed, in our view, by several disadvantages.
First, as the reports had the look and feel of a more intensive compliance review, there was no
obvious reason why they should be taken any more seriously by the trusts concerned than they
would a normal compliance review report. Indeed there is a good reason why they might have
regarded the investigations as being less significant, since the recommendations contained within
them are not associated with any enforcement powers. At both trusts there were Warning Notices in
force at the time the investigations were authorised and outstanding Compliance Actions from earlier
regulatory activity. These were mandatory for the trusts; the recommendations in the investigation
reports were not.
Second, the outcome standards against which the investigations were conducted and reported apply
only to regulated bodies but, as we have already noted, a specific purpose of the S.48 power is to
allow CQC to examine wider systemic issues which go beyond regulated bodies. It is not clear to us
how this could have been satisfactorily achieved using the approach adopted.
Third, even within the regulated trusts a clear purpose of the power to conduct investigations is to
examine weaknesses in governance, leadership and culture which are impacting on users of
services. We have been advised that this was approached, using the compliance framework,
through examining compliance with outcome 16. This refers to the way in which providers assess
and monitor the quality of service provision. However, in interviews CQC staff have acknowledged
that there is a distinction to be made between clinical governance and corporate governance and
leadership in its wider sense, and that outcome 16 focuses on the former. We note that at no time
have concerns in respect of outcome 16 been expressed through compliance activity at BHRT,
although there were clearly weaknesses in corporate governance which have prompted action to
remedy them.
Deloitte commentary:
The reports were structured in such
a way that gave them the look and
feel of a more comprehensive
compliance review, which was in
part due to the methodology used.
This meant that they did not provide
additional analysis and information
that would go significantly beyond
the remit of a compliance review,
which S.48 powers are designed to
address.
There were a significant number of
recommendations raised within
both of the investigation reports (79
at BHRT and 40 at UHMB), which
were not prioritised. We consider
that it would have been more
helpful and effective for the
attention of the trusts concerned to
be focused on a small number of
issues which had been identified as
underlying causes.
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4. Reporting and impact of the investigations
4.1. Reporting (continued)
Moreover, there have been major concerns expressed in relation to outcome 16 at BTT where no
investigation took place. To address the wider governance and leadership issues directly it would, in
our view, have been necessary to adopt a methodology that had this objective specifically in mind.
We would comment too that in our view the S.48 power exists to enable CQC to report on the things
that really matter and which would not emerge with the same clarity from an intensive compliance
review. However, the BHRT investigation report contained 79 recommendations and the UHMB
report 40. In neither case were they clearly prioritised and we were instead told that any
recommendation in the report was to be regarded as a priority for the trust. We consider that it would
have been more helpful and effective for the attention of the trusts concerned to be focused on a
small number of issues which had been identified as underlying causes.
Similarly, we understand that dissemination of the investigation reports to the two trusts was
identical to that of a normal compliance review in that they were simply emailed and/or posted to the
Chief Executive of the trust concerned. While the investigation team leaders gave verbal feedback to
the Chief Executives and senior staff of the trusts before writing the report, in our experience other
regulators exercising powers of this kind would send an individual copy of the report to every
member of the board of the trust and might insist on presenting it at a specially convened board
meeting. In the event, although the investigation reports were in fact discussed by the boards of the
trusts, CQC staff leading the investigation teams had no further involvement at the trusts once their
report was finalised.
Deloitte recommendations:
12. We note that the new
framework of investigation
reports states that the reports
should be written against the
terms of reference and agree
with this approach. However, in
order for this to lead to a more
strategic approach the
recommendations raised in the
methodology section above
would also need to be
implemented.
13. Reports should focus on a
smaller number of
recommendations that tackle the
underlying causes of the issues
at the trusts.
14. Consider how investigation
reports are fed back to the
Trusts. For example, CQC could
attend a Board meeting at the
trust to present and challenge
the Board members around the
key findings
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4. Reporting and impact of the investigations
4.2. Impact of the investigations
The investigations did have some benefits, however there were also negative consequences on the trusts involved.
In making the observations in Section 4.1 in relation to the reporting of the investigations we are not
suggesting that the investigations lacked impact. However there are mixed views about whether the
impact they undoubtedly had merited the distraction and loss of morale they caused or could not
have been achieved in other ways. The distraction was real and substantial. The investigations
caused a degree of confusion for both CQC and the trusts concerned as compliance actions and
warning notices could not be followed up while the investigations were taking place, and therefore
lapsed. More importantly, they caused disruption to improvement plans at the trusts that had already
been put in place, they caused delay in recruitment to key executive positions, and they placed huge
strain on management capacity at a critical period in the effort to turn round the performance of the
trusts concerned.
Although they were not welcomed for these reasons, the trusts nevertheless tried to make the best
use they could of the investigations once they became inevitable and did so to good effect. They
were seen, both within the trusts and by CQC, as providing new Chief Executives with an
unambiguous mandate for change internally, helping to align key external stakeholders behind the
improvement plans and lending support to those plans more generally. This was useful although it
was also felt that these benefits did not justify the cost to the trusts of the downside referred to above
as they could have been achieved in less disruptive ways.
The investigations were also regarded as having been helpful in bringing all the issues of concern
together in a coherent way. There is, however, very wide agreement that CQC learned very little
from the investigations that it did not already know.
The generally held view within CQC is that the major impact of the investigations was that the
publicity they generated caused action to be taken, especially by the SHA in both cases, which
resulted in improvements taking place. However, we would question the belief within CQC that it
was the investigations which prompted action by others. As we have noted, in the case of UHMB
decisive action had already been initiated by Monitor from the point at which the trust was deemed
to be in significant breach of its terms of authorisation.
Deloitte commentary:
The general consensus from the
interviews and our review of the
evidence provided was that the two
case study investigations did not
result in any significant new
information being uncovered.
The investigations did have some
benefits, in that they brought
together the issues for each trust in
a coherent way and they provided
the new leadership team with a
mandate for change.
However, there were negative
impacts on the trusts involved, in
particular significant disruption and
distraction at a time when the new
leadership teams were trying to
implement improvements.
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4. Reporting and impact of the investigations
4.2. Impact of the investigations (continued)
Also at BHRT, the SHA had already taken action to strengthen the leadership of the trust before the
decision to investigate was taken, including the appointment of a new Chief Executive and new non-
executive directors. Further, although more decisive action was taken by the SHA in September
2011 during the period following the conclusion of the work on site and before the publication of the
investigation report in October, we understand that this was prompted by a CQC decision that month
to restrict maternity services at the trust arising from a compliance review and was not specifically
an outcome of the investigation.
We would add that if galvanising others into action was a prime purpose of the investigations, there
were other actions open to CQC to raise the profile of its concerns, both prior to the decision to
investigate and when presenting the investigation reports.
For example, it is the normal practice at Monitor when there are concerns that a Foundation Trust
may be about to be declared in significant breach of its terms of authorisation, or has not taken
adequate steps to remedy such a breach, to convene an escalation meeting with the Chair and Chief
Executive of the Trust and the Chair and Chief Executive of the regulator. If this does not lead to the
concerns being taken more seriously, Monitor will occasionally insist on a special meeting with the
full board of the trust concerned.
CQC adopts a similar approach but in a lower level way. Chief Executives of trusts causing concern
are occasionally invited in to discuss the concerns, but it is rare for Chairs to be involved in such
meetings and in the past the CQC presence has not normally involved the Chief Executive of CQC
or her deputy. We welcome the fact that the new CQC Chief Executive has chosen to join Monitor
at the next of a series of regular monthly meetings with BTT, which Monitor has been holding with
the trust since declaring it to be in significant breach of its terms of authorisation as a Foundation
Trust.
We are aware that CQC’s express legal powers are limited and differ from those of Monitor, but we
believe that it is unlikely that any Chair of a body providing essential public services would feel able
to decline a request from their quality regulator for a high level meeting.
Deloitte commentary:
We are not fully convinced by the
view of staff within CQC that the
main impact of the investigations
was that it galvanised the local
health economy, particularly the
SHAs into taking action. This is
mainly because in relation to both
Trusts significant action had already
been taken, such as changing the
leadership teams, prior to the
investigations being announced.
From our experience of working
with other regulators, we also
consider that there are other
actions that CQC could take which
would raise the profile of its
concerns. For example, the Chair
and Chief Executive of CQC having
escalation meetings with the Chair
and Chief Executive of the trust or
organisation involved.
30 Care Quality Commission Third party review of CQC regulatory approach
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© 2013 Deloitte LLP
4. Reporting and impact of the investigations
4.2. Impact of the investigations (continued)
There are other practices adopted by Monitor and other regulators which we consider that CQC
could usefully adopt. For example when there are significant concerns about governance, rather
than committing substantial CQC resources to an investigation, it might first suggest to the trust
concerned that it should commission its own review of governance, or call upon other external
support, thereby ensuring that any recommendations are more likely to be owned by the trust.
Suggestions of this kind would carry even more weight if CQC felt able to adopt a more creative use
of its power to impose conditions on registration, including retrospectively. We understand that CQC
is beginning to do so, although it is understandably cautious as it recognises that further steps in this
direction would increase the risk of facing litigation. Ultimately the appetite for risk in this regard is a
matter for the CQC Board to consider and we are not aware that it has yet done so.
We have tested these views in interviews with senior staff at case study trusts and have found that
they would in general favour a more open high level engagement with CQC and would be receptive
to suggestions, drawing on CQC’s experience, as to how best to drive improvement especially
where this requires a change of culture.
In relation to both routine compliance work and investigations, trusts are required to produce an
action plan, which lays out how they will respond to the recommendations within the CQC report.
The action plans are followed up by CQC as part of its compliance work at the trusts after the
timeframe that has been set by the Trust. If CQC regard the action plan to be insufficient, it will ask
the relevant trust to amend its proposed actions or timelines. However, overall CQC provide very
little feedback on the actions plans that trusts produce and the understandable focus of CQC on its
powers and duties under the Act and the Regulations defining the outcome standards means that it
has not been required to develop or articulate a model of how change takes place in organisations
as large and complex as acute hospitals.
Deloitte recommendation:
15. CQC needs to develop and
articulate a view about how to
drive improvement in an
organisation where leadership,
governance and cultural issues
are at the core of its concerns.
31 Care Quality Commission Third party review of CQC regulatory approach
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© 2013 Deloitte LLP
5. Liaison with other stakeholders
5.1. Liaison with other stakeholders (continued)
There is regular engagement between CQC and other relevant stakeholders
We have observed during the course of our review that CQC regularly undertakes inspections jointly
with professional bodies such as the Nursing and Midwifery Council or other regulators such as the
Health and Safety Executive. We have noted too that part of the decision making process at all three
of our case study trusts were risk summits convened by CQC and involving a wide range of
stakeholders at which the issues of concern were fully aired and actions to be taken by each of the
relevant authorities were agreed. We have noted that in respect of Foundation Trusts there is
information sharing and joint decision making with Monitor on a weekly or even daily basis as
necessary, and that the information shared includes “soft” intelligence as well as planned regulatory
activity and other more formal matters. We regard all of this as examples of good practice. But the
quality of the liaison with SHAs and with Monitor (in respect of Foundation Trusts) is of such
importance that the relationship with these bodies merits separate and deeper comment.
We are of course aware that SHAs will not be a part of the new landscape of NHS bodies created by
the Health and Social Care Act 2012. But we expect that regional emanations of the NHS National
Commissioning Board will play a similar role, so the NHS reforms do not negate the value of
examining the role of the SHA in promoting improvement at our case study trusts. This is because,
as noted above, it has been reported to us that the SHA was not in favour of an investigation at
either of the two trusts where one took place. We consider that there are arguably good reasons for
this, especially as it is apparent from what we have learned about the risk summit that preceded the
investigation at UHMB that none of the other stakeholders were in favour of it. This does, however
raise questions in our mind about the dual, and possibly conflicting, nature of the role of an SHA,
which is likely to be replicated within the NHS National Commissioning Board and which CQC needs
to remain conscious of.
SHAs have had a vital role in monitoring and managing the performance of NHS trusts and ensuring
the delivery of high quality services, but they have also been a key part of the management
hierarchy of the NHS, with a responsibility to protect its reputation from unwarranted attack. As such,
they have not been in the same position as independent regulators of the NHS, such as CQC and
Monitor, and nor will any successor bodies to them. We therefore believe CQC should consider
engaging more directly with Boards rather than relying on the role of SHAs (or any successor bodies
to them).
Deloitte commentary:
Overall we have seen evidence of
good communication with other
stakeholders and particularly other
regulators.
32 Care Quality Commission Third party review of CQC regulatory approach
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© 2013 Deloitte LLP
5. Liaison with other stakeholders
5.1. Liaison with other stakeholders
We have not detected any similar conflict in the position taken by Monitor. Two of our case study
trusts, UHMB where an investigation occurred and BTT where the S.48 power was not used, are
Foundation Trusts. In both cases there was good and regular liaison with Monitor, a shared view of
the nature of the concerns about performance, and an understanding by both parties of which of the
bodies had the most appropriate powers and evidence base to justify intervention.
The nature of the liaison between CQC and Monitor is especially evident in the case of BTT, which
is discussed in section 2.3.
Finally, in relation to liaison with other stakeholders, we have some observations for CQC to
consider about its engagement with local authorities. We have not interviewed any representatives
of local authorities during the course of our review but the role of local authorities has featured
several times in our interviews, yet we have noted that there was very little comment about them in
the investigation reports we have examined. We are aware too that the role of local government in
the health sector is changing and becoming more important. Local authorities will soon be
responsible for public health, the establishment of the health and wellbeing boards and sponsorship
of local healthcare watchdog groups, which will be supported at a national level by Healthwatch
England, a statutory committee within CQC. Moreover there are already some concerns at a local
level about the integration of the CQC and local authority policies. In particular, we have been told
that the approach to the safeguarding of vulnerable people evidenced by the CQC interventions at
one of the case study trusts is at variance with that adopted by the Council across the county as a
whole. We have not looked into this more deeply as it was not within our terms of reference, but we
consider that CQC would be wise to give careful thought to how it engages with local authorities and
their new powers and responsibilities in the future.
Deloitte recommendations:
16. CQC should review how it
engages with local authorities,
especially in relation to their new
powers and responsibilities in
the future.
33 Care Quality Commission Third party review of CQC regulatory approach
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© 2013 Deloitte LLP
6. Other issues
6.1. Other issues
Other issues have arisen during the course of our review which were outside our terms of reference, those which
have been sufficiently close to our core purpose or of sufficient importance to warrant mention in this report are
included below.
Generic Inspectors:
The teams that conducted the two case study investigations were well led and highly competent.
However questions have arisen in a few of our interviews with external stakeholders about the
quality, consistency and proportionality of some of the judgements made by CQC inspectors during
routine compliance work. In particular, we have been made aware of a concern about the use of
inspectors at NHS trusts who have a background solely in social care and the problems this creates
for their credibility with clinicians. We consider that CQC should question its generic approach to
inspection and take steps to satisfy itself that this generic approach across the whole of health and
social care, with acute hospitals being inspected by people who have never worked in the NHS, is
valid.
National Professional Advisors (‘NPA’):
National Professional Advisers are an important clinical resource for CQC, however until very
recently, they appear to be have been used in a sub-optimal way. Although they were involved in
the investigations, either directly or indirectly by recommending clinical specialist support, their role
in on-going compliance activity is ill-defined and communication between the NPAs and senior CQC
management has not always been good. We were told that this has improved dramatically in recent
months and that there are now regular and constructive meetings with the Chair of the Commission.
We were also told that although the new Chief Executive has been in post for only a short period of
time he appears to attach some importance to his meetings with the NPA and to regard them more
as an opportunity to listen and reflect than to convey information (which was the practice in the
past). This is welcome, but we nevertheless feel that CQC could benefit from having greater clarity
about the role of its NPAs and we believe the advisers would welcome this. We would therefore
suggest that CQC should consider, at an appropriate point, a review of its access to professional
clinical advice and the use that it makes of this advice.
Deloitte recommendations:
17. CQC should question its
generic approach to inspection
and take steps to satisfy itself
that this generic approach
across the whole of health and
social care, with acute hospitals
being inspected by people who
have never worked in the NHS, is
valid.
18. CQC should consider, at an
appropriate point, a review of its
access to professional clinical
advice and the use that it makes
of this advice.
34 Care Quality Commission Third party review of CQC regulatory approach
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© 2013 Deloitte LLP
6. Other issues
Introduction │Executive Summary │ Findings and commentary │Recommendations │Appendices
6.1. Other issues
Internal communication
We also consider that there are issues for the new Chief Executive to address in relation to
communications within CQC itself. We have observed above that many aspects of regulatory
decision making within CQC are highly devolved. The risks associated with this were managed at a
national level during the period we have been primarily concerned with by a Risk and Escalation
Committee, which has subsequently been replaced by a new Regulatory Risk Committee. It is
intended that the new committee should have a more strategic focus than its predecessor, but it has
been in existence for too short a time to know whether this is likely to be the case.
However, regardless of the way in which the new management structures are defined, we believe
they need to address a concern that has repeatedly been reported to us about weaknesses in
feedback to front-line staff about decisions taken at a national level concerning trusts in which they
are directly involved. Staff in day to day contact with the case study trusts were not consulted about
the terms of reference of the investigations that were conducted and the perception of some of them
is that they diligently and regularly reported their concerns about these trusts upwards, but did not
receive feedback the other way. For example often the staff concerned were invited to make
presentations to national level committees, but were not invited to participate in the subsequent
decision-making and on several occasions it was not clear to them where or why key decisions had
been taken.
CQC is very far from being unusual in this respect. It is an everyday problem confronting all national
organisations with a highly dispersed workforce and there is no easy solution to it. It is also a more
difficult problem for public bodies which are likely to attract a high degree of media criticism of
expenditure on actions to bring staff together to share experiences and receive nationally important
messages. However it is precisely because of this that we consider more attention needs to be paid
by CQC to downward and horizontal communication with its staff than we have observed from our
review.
Deloitte recommendations:
19. CQC should review the
communication channels across
the organisation to ensure there
is appropriate two-way
communication between the
senior management team and the
operational teams in the regions.
35 Care Quality Commission Third party review of CQC regulatory approach © 2013 Deloitte LLP
Deloitte UK print A4 (21.00 cm x 29.70 cm)
Recommendations
© 2013 Deloitte LLP 36 Care Quality Commission Third party review of CQC regulatory approach
Recommendations
Ref. Section Recommendation(s) Suggested
owner
Completion
date
1.1 Strategic versus
operational power
1. The Board should identify those regulatory matters it considers to
be strategic.
2. Decisions relating to these powers should be reserved to the
Board.
2.1 Evidence and
propriety of
decision to
investigate
3. The decision to carry out an investigation under S.48, together
with the reasons for the recommendation should be made in
writing. The final basis of the decision should be clearly
documented and both should be retained.
3.1 Resourcing the
investigation
4. Determine in advance a budget for the investigation, which
includes both the direct costs of the investigation, for example
expenses, fees to external experts and the internal staff costs.
5. Put in place a dedicated team for each investigation, who are
involved across all stages of the investigation. The team should
be involved in reviewing relevant sections of the draft report.
6. The clinical and non clinical external advisors should review and
comment on the findings draft investigation reports.
37 Care Quality Commission Third party review of CQC regulatory approach
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© 2013 Deloitte LLP
Recommendations (continued)
Ref. Section Recommendation(s) Suggested
owner
Completion
date
3.2 Methodology 7. Develop a methodology/ toolkit which investigation teams can
draw upon when scoping and planning an investigation. In
particular these should include guidance on how to investigate
governance and leadership from Board to Ward.
8. Further consider how CQC can use the work from other
regulators and in relation to Monitor look at the where the two
regulatory frameworks meet and how the two can be dovetailed
to prevent duplication.
9. Ensure that staff understand the strategic nature of the
investigation powers and the key differences to a compliance
review.
10. Ensure all communication to staff (all 3 policy documents) clearly
express the nature of the S.48 power.
3.3 Quality assurance
processes
11. For each investigation, as part of the quality assurance process,
ensure the draft report is reviewed and challenged by a suitably
experienced manager who is independent of the investigation.
4.1 Reporting 12. We note that the new framework of investigation reports states
that the reports should be written against the terms of reference
and agree with this approach. However, in order for this to lead
to a more strategic approach the recommendations raised in the
methodology section above would also need to be implemented.
13. Reports should focus on a smaller number of recommendations
that tackle the underlying causes of the issues at the trusts.
14. Consider how investigation reports are fed back to the Trusts.
For example, CQC could attend a Board meeting at the trust to
present and challenge the Board members around the key
findings
38 Care Quality Commission Third party review of CQC regulatory approach
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© 2013 Deloitte LLP
Ref. Section Recommendation(s) Suggested
owner
Completion
date
4.2 Impact of the
investigations
15. CQC needs to develop and articulate a view about how to drive
improvement in an organisation where leadership, governance
and cultural issues are at the core of its concerns.
5.1 Liaison with other
stakeholders
16. CQC should review how it engages with local authorities,
especially in relation to their new powers and responsibilities in
the future.
6.1 Other issues 17. CQC should question its generic approach to inspection and take
steps to satisfy itself that this generic approach across the whole
of health and social care, with acute hospitals being inspected by
people who have never worked in the NHS, is valid.
18. CQC should consider, at an appropriate point, a review of its
access to professional clinical advice and the use that it makes
of this advice.
19. CQC should review the communication channels across the
organisation to ensure there is appropriate two-way
communication between the senior management team and the
operational teams in the regions.
Introduction │ Executive Summary │ Findings and commentary │ Recommendations │ Appendices
39 Care Quality Commission Third party review of CQC regulatory approach
Recommendations (continued)
© 2013 Deloitte LLP
Appendix 1 : Terms of reference
© 2013 Deloitte LLP 40 Care Quality Commission Third party review of CQC regulatory approach
Appendix 1: Terms of references
41 Care Quality Commission Third party review of CQC regulatory approach
Purpose of the review
To review CQC’s use of its investigation powers set out in section 48 of the Health and Social Care Act 2008 in relation to NHS Hospital Trusts
where they have been unable to meet, or meet and then sustain, essential standards of quality and safety.
CQC wishes to review the use of its powers including the production of public information use of investigation as a tool, effectiveness in deciding
when to use investigation and our ability to implement the investigation tool.
The review will include consideration of the effectiveness in deciding when to use these powers and CQC’s ability to use its powers and resources
proportionately and effectively to protect and promote the health, safety and welfare of people who use the services of the bodies being
investigated.
Investigation powers have been used in relation to a number of NHS Trusts and the reports of these investigations have now been published,
making them available as case studies.
Following conclusion and publication of these investigation reports, CQC wish to commission a third party review of its use of different regulatory
powers as part of its ongoing focus upon and commitment to quality assurance and improvement.
Scope
The scope of the review is to consider how regulatory approaches may be improved by examining case studies of completed investigations into
NHS Trusts where they have been unable to meet or sustain essential standards of quality and safety, considering:
Scope Considered within the report in section:
i. Whether the assessment of risk before investigation powers were utilised was broadly correct
– and where the trigger point was for investigation Section 2.1 and 2.3
ii. Whether a reasonable degree of inspection and investigation of the Trusts was specified and
undertaken taking account of the level of assessed risk and resources required Section 3.2
Iii. Whether appropriate and sufficient information was received from the Trusts and appropriate
inspection and investigation was undertaken to achieve the degree of assurance in the
specification
Section 3.2 and 3.3
iv. Whether sufficient and appropriately skilled resources were allocated to collate information
received, observe and draw conclusions Section 3.1
Introduction │ Executive Summary │ Findings and commentary │ Recommendations │ Appendices
© 2013 Deloitte LLP
Appendix 1: Terms of references (continued)
Introduction │ Executive Summary │ Findings and commentary │ Recommendations │ Appendices
42 Care Quality Commission Third party review of CQC regulatory approach
Scope Considered within the report in section:
v. Whether appropriate and proportionate action was required of the Trusts Section 4.2
vi. Whether follow up of the required actions were sufficiently robust, and the management
control over the follow up was appropriate. Section 4.2
vii. Overall, whether the CQC regulation of NHS Trusts is proportionate and reasonable given the
legal, regulatory and geographical context of the Trust; and the organisation context of CQC
during the period April 2009 to July 2012
Section 1.1 and 2.2
(context of this is in relation to
investigations)
viii. What changes, if any, should be made to CQC’s policies and procedures to improve the
handling of similar cases in the future.
Recommendations, Section 4.2, 5.1 and
6.1
List of people interviewed as part of the review:
CQC staff
Director of Operations – Amanda Sherlock
Head of Regulatory Risk & Quality – Louise Dineley
Deputy Chief Executive– Jill Finney
Deputy Director of Operations– Matthew Trainer
Compliance managers – Tony Allen, Rob Assall, Janet Ortega, and
Joanne Wildman
Compliance Inspectors – Beverley Gray, Sue Fraser-Betts and
Marian Whittam
Lead investigators – Adam Brown and Mandy Musgrave
Head of Regional Compliance – Vicky Wells and Ann Ford
Regional Lead - Debbie Westhead
Head of Regulatory Design – Rachel Dodgson
Design Team Leader – Sarah Bell
Board members
Chair – Dame Jo Williams
Chair of ARAC – Prof. Deidre Kelly
Commissioner – Kay Sheldon
List of people interviewed as part of the review:
National Professional Advisors
Ann Farenden
Dr Nick Bishop
External Stakeholders
Chief Operating Officer Monitor - Stephan Hay
Chief Nurse NHS London – Trish Morris-Thompson
BTT interviewees
Chief Executive – Clare Panniker
Medical Director – Dr Stephen Morgan
Director of Nursing – Diane Sarker
BHRT interviewees
Chief Executive – Averil Dongworth
Medical Director – Dr Mike Gill
Director of Nursing – Flo Panel-Coates
© 2013 Deloitte LLP
Appendix 2 : Section 48 of the Health & Social Care Act 2008
© 2013 Deloitte LLP 43 Care Quality Commission Third party review of CQC regulatory approach
Appendix 2: Section 48 of the Health & Social Care Act 2008
Introduction │ Executive Summary │ Findings and commentary │ Recommendations │ Appendices
44 Care Quality Commission Third party review of CQC regulatory approach
Section 48 - Special reviews and investigations
(1) The Commission may conduct any special review or investigation, and must do so if the Secretary of State so requests.
(2) A special review or investigation is a review (other than a periodic review) of or an investigation into:-
a) the provision of NHS care;
b) the provision of adult social services; or
c) the exercise of functions by English Health Authorities.
(3) Such a review or investigation may relate:-
a) to the overall provision of NHS care or adult social services or to the provision of NHS care or adult social services of a particular
description;
b) to the overall exercise of functions or to the exercise of functions of a particular description; or
c) to the provision of care or services or the exercise of functions by bodies or persons generally or by particular bodies or persons.
(4) Where the Commission conducts a review or investigation under this section, it must publish a report.
(5) The Commission must consider whether the report raises anything on which it ougth to give advice to the Secretary of State under section
53(2).
(6) If the review or investigation gives rise to a duty to act under section 50(2) or (3) in respect of an English local authority, subsection (5)
does not apply in relation to so much of the report as relates to that local authority.
(7) The Secretary of State may, after consulting the Commission, by regulations make provision as to the procedure to be followed in respect
of the making of representations to the Commission before the publication of a report under subsection (4).
(8) In this section “English Health Authority” means:-
a) a Strategy Health Authority; or
b) a Special Health Authority performing functions only or mainly in respect of England.
© 2013 Deloitte LLP
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