Lucy Moffatt

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CareQuality

Commission
: 2 Care Quality Commission
: Zz J AUS 2 Citygate
t Gallowgate
: Newcastle upon Tyne
Christopher Dorries NE1 4PA
HM Senior Coroner South Yorkshire (West) Telephone: 03000 616161
Medico-legal Centre Fax: 03000 616171
Watery Street
Sheffield www.cqc.org.uk
$3 7ES
19 August 2014

BY EMAIL and POST
Re: Inquest into the death of Miss Lucy Moffatt
Dear Mr Dorries

Thank you for your letter dated 10 June 2014 in which you wrote to us under the
provisions of Regulation 28 of the Coroners (Investigations) Regulations 2013 (‘the
Regulations’) in relation to the inquest into the death of Miss Lucy Moffatt.

We are extremely saddened to learn of the death of Miss Moffatt and of the
circumstances leading to her death. We are also very grateful for your report in
requiring us to review what actions should be taken to prevent the occurrence or
continuation of such circumstances in the future.

Please treat this letter as the formal response of the Care Quality Commission
(‘CQC’) to your report dated 10 June 2014.

In your report and pursuant to the requirements of Regulation 29 of the Regulations
you require the CQC to provide details of any action that has been taken or which is
proposed to be taken in response to the concerns highlighted in your report, or an
explanation as to why no action is proposed if appropriate.

{In accordance with the evidence that was given at the inquest neither the registration
assessor nor the compliance inspector in this case were specifically aware of the
Department of Health Alert concerning the strength of window restraints referred to in
Health Technical Memorandum (HTM) 55. The reason for this lies in the regulatory
framework in which health and social care providers are registered to operate, and in
accordance with the current registration and inspection CQC methodology. Under the
current statutory and regulatory framework the primary responsibility for managing
patient safety, and ensuring that such alerts are actioned, lies with the provider of
health and social care providers. As you will be aware that framework is formed
primarily of the Health and Social Care Act 2008 (‘the Act’), as well as the Care
Quality Commission (Registration) Regulations 2009 (‘the Registration Regulations’)

and the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010
(‘the Regulated Activities Regulations’).

Under Regulation 16 of the Regulated Activities Regulations, the registered person,
that is Sheffield Crisis in this case, must make suitable arrangements to protect
service users and others who may be at risk from the use of unsafe equipment by
ensuring that equipment provided for the purposes of carrying out the regulated
activity is properly maintained and suitable for its purpose, and used correctly. How
this regulation is complied with will be taken into account by the CQC at registration
and subsequent reviews of compliance. However, at this stage the CQC does not
mandate exactly what systems or equipment or systems should be in place while the
burden falls on the provider to ensure that they take account of Alerts such as HTM
55 in devising the particular window restrictor or that is used.

The CQC is committed to continuous improvement and takes extremely seriously the
concerns that you raised. We consider that your concerns touch upon the broader
question of the implementation and inspection of Safety Alerts more generally.
Accordingly, in addressing your concerns we set out the steps that the CQC is
undertaking to improve the effective implementation of Safety Alerts.

In seeking to address the concerns raised in your report we structure our response
as follows:

1. Clarification of duties on providers to implement safety alerts;
2. CQC's regulatory role; and

3. Steps taken by the CQC to address the concerns set out in your report.

1. Duties on providers to implement safety alerts

The CQC recognises that Safety alerts as. encompassing a variety of vital
communications produced by the Medicines and Healthcare products Regulatory
Agency (MHRA), the former National Patient Safety Agency (NPSA), NHS England
and the Department of Health, including the following:

. National Patient Safety Agency (NPSA) safety alerts
NHS England safety alerts and guidance

Rapid response alerts.

Emergency alerts.

Drug alerts.

Dear doctor letters.

Medical device alerts.

We recognise that alerts cover a wide range of topics, from vaccines to patient
identification and the types of alerts include Rapid Response Reports and Safer
Practice Notices as well as Patient Safety Alerts.

The CQC also recognises alerts as important mechanisms to help providers learn
lessons from each other and to improve the quality of care they provide. They also

offer providers an opportunity to demonstrate their accountability for the safety of
people who use services.

You will be aware that patient safety alerts and other safety critical guidance are
issued by the Central Alerting. System (‘CAS’) by email: The system is currently
hosted and administered by the Medicines and Healthcare products Regulatory
Agency, while details of specific alerts can be accessed by the CAS website:
(https://www.cas.dh.gov.uk/Home.aspx).

All alerts are issued to each organisation registered with CAS, regardless of whether
or not they might be relevant. The number of alerts relevant to an organisation varies
considerably depending on their size, nature of business and services they provide.
Each alert indicates the type of organisations it is relevant to, but it is up to providers
themselves to consider each alert for relevance and to update CAS accordingly.
Meanwhile, each alert has an issue date, an ‘acknowledged by’ date and a
completion deadline. A single alert may include a number of separate actions, each
with different completion dates.

By way of background the Health and Social Care Act 2008 introduced a single
registration system which applies to both healthcare and adult social services. Once
registered with the CQC, providers such as Sheffield Crisis are required to comply
with conditions placed on their registration, as well as under the Act, and the
Regulated Activities and Registration Regulations. The Regulations set out the
essential standards of quality and safety that service users have a right to expect.
The Act requires the CQC to publish guidance about compliance with the
requirements of the regulations and accordingly. the CQC has published “Guidance
about compliance, Essential standards of Quality and Safety” (‘the Guidance’) which
provides advice to providers about how and what they need to do to comply with the
Regulations in the form of outcomes and prompts.

The requirements on providers to deal with Alerts depends the nature of the provider
and varies according to whether they are NHS Trusts, Primary Care contractors or
other providers such as Crisis House, as follows:

1. NHS Trusts

All NHS trusts must be registered with the system to receive alerts, act on
them and feed-back information on compliance. There are also more specific
requirements for NHS trusts under the essential standards in outcomes 4M
and QJ in relation to National Patient Safety Agency alerts.

¢ Outcome 4M constitutes a specific additional prompt for specific service
types in the context of Outcome 4, which refers to Regulation 9 of the
Regulated Activities Regulations dealing with the care and welfare of
service users. It appears at page 69 of the current Guidance and sets
out that service providers must make sure that people who use services
benefit from a service that “ensures that patient safety alerts, rapid
response reports and patient safety recommendations issued by the
National Patient Safety Agency (NPSA) and which require action are
acted upon within required timescales’.

e Outcome 9J constitutes an additional prompt within the context of
Outcome 9, which refers to Regulation 11 of the Regulated Activities
Regulations dealing with the management of medicines. It appears at
page 109 of the current Guidance and sets out as follows: “Ensure that
patient safety alerts, rapid response reports and patient safety
recommendations disseminated by the National Patient Safety Agency
and which require action are acted upon within required timescales’.

Primary Care Contractors

NHS England has a responsibility to cascade alerts to their primary care
contractors for action where appropriate and to monitor the implementation of
alerts by contractors. This function had historically been managed by previous
commissioning organisations and transferred to NHS England’s Area Teams
from the 1st April 2013.

Draft guidance has been prepared on this responsibility. We understand that
that guidance includes as follows but we respectfully invite you to contact the
NHS England for further details:

e Area Teams will be required to use CAS for issuing and responding to
alerts, confirming that the alert has been received and cascaded onwards
for action as appropriate.

e Implicit in this’is the expectation that Area Teams will monitor the
implementation of alerts, by primary care contractors, given iheir
responsibility to ensure that the services they commission are safe. Each
Area Team will have a designated CAS liaison officer (with appropriate
back up cover) responsible for cascading alerts to primary care contractors
and making responses on CAS.

e In relation to independent providers, Area Teams are only required to
cascade alerts to independent contractors before signing off the alert
‘Complete’. This must be within 5 working days. Feedback from
independent contractors does not need to be included in the response to
CAS but local processes should be in place to monitor their compliance
with alerts to ensure that safe services are being commissioned. While not
currently nationally mandated, these local processes should include
compliance with relevant alerts being considered as part of regular
assurance or contract review processes. The specification of a standard
process for reviewing compliance is currently being considered.

Other providers

All other providers have been advised by CQC to register directly with CAS to
receive alerts to ensure they are complying with the regulations. These
providers would. include providers such as Sheffield Crisis. However, the
system's functionality does not allow them to feed-back information on
compliance status to CAS in the same way as NHS providers. CQC has no
role in distributing safety alerts to independent healthcare or adult social care

providers (as communicated by letter), unlike its predecessor, the Healthcare
Commission or Commission for Social Care Inspection.

While independent healthcare and social care providers such as Sheffield
Crisis are not mandated in the same way as NHS providers to implement
alerts issued by CAS, they are required nevertheless to comply with
requirements in the essential standards of quality and safety as set out in the
Guidance. Providers are required to take into account the CQC’s Schedule of
Applicable Publications as detailed at Appendix B where they are required to
do so within the context of relevant regulations. In particular:

1.

Within the context of regulation 9 of the Regulated Activities Regulations
(Outcome 4) dealing with the care and welfare of service users, providers
must take account of relevant evidence based guidance about good
practice and alerts published by expert and public bodies including the
National Patient Safety Agency.

2. Within the context of regulation 15 of the Regulated Activities Regulations

(Outcome 10) dealing with the safety and suitability of premises, providers
must take account of alerts, responses, guidance and directives about all
aspects of healthcare and social care premises published by agencies
including the National Patient Safety Agency, the Department of Health
and the Health and Safety Agency. Accordingly, as with all providers
Sheffield Crisis had responsibility for taking into account the Health
Technical Memorandum (‘HTM’) 55 which had been issued by the
Department of Health. The Health and Safety Executive also first published
August 2012 in Health Sheet Information Sheet No 5 guidance that
incorporated at page 2 the concerns set.in HTM55 as follows:

“Control measures

Suitable controls may include:

e fitting adequate window restrictors;

e ensuring balconies have edge protection that is sufficiently robust,
and of suitable design (including height, and the size of any
openings in it), to prevent accidental falls;

e fitting an adequate screen or barrier to prevent service user access
to a window or balcony edge;

e restricting access to upper floors.

Window restrictors

e Where vulnerable people have access to windows large enough to
allow them to fall out and be harmed, those windows should be
restrained sufficiently to prevent. such falls. Window restrictors
should:

o restrict the window opening to 100 mm or less;
o be suitably robust to withstand foreseeable forces applied by .
an individual determined to open the window further;

o be sufficiently robust to withstand damage (either deliberate
or from general wear);

o be robustly secured using tamper-proof fittings so they
cannot be removed or disengaged using readily accessible
implements (such as cutlery) and require a special tool or key
(see Department of Health Building Note 00-10 Part D
Windows and associated hardware). Please note that ‘safety
restricted hinges’ that limit the initial opening of a window can
be overridden without the use of any tools and are not
suitable in health and social care premises where individuals
are identified as being vulnerable to the risk of falls from
windows.

Care providers should also:

e ensure the window frames to which restrictors are fitted are
sufficiently robust;

e consider any impact on the comfort of service users from reduced
natural ventilation and provide adequate cooling where necessary
(eg high-level and/or restricted aperture ventilation, fans or air
conditioning). The NHS has produced guidance on dealing with
extreme heat and heatwaves.”

3. Regulation 10 of the Regulated Activities Regulations (Outcome 16):
dealing with assessing and monitoring the quality of service provision,
providers must take account of relevant guidance, national reports. and
codes of conduct about risk management, monitoring quality and audit
published by expert and professional bodies, including the National Patient
Safety Agency.

Commissioners of NHS services from non-NHS providers also have a responsibility
to ensure they are commissioning safe services. Accordingly, this would include
ensuring that relevant safety alerts are implemented by any independent providers
they contract with.

2. CQC’s requlatory role

A new system of regulation came into force in April 2010, and providers were
required to demonstrate compliance with the Registration Regulations. Whilst there
were no specific regulations explicitly requiring compliance with safety alerts, this was
included as something to be taken into consideration in the ‘Guidance about
compliance with Essential Standards of Quality and Safety’ for all provider types with
the exception of Shared Living and Extra Care providers.

The CQC tested both initial and ongoing compliance by establishing a dynamic
Quality and Risk Profile (QRP) for each provider organisation. This included data that
provided CQC with an insight into the risks of non-compliance with the regulations.

For the reasons stated above, compliance data from CAS did not feed into the early
QRPs, but the data was subject to a number of data quality improvements by the

Department of Health and two new indicators were introduced in July 2010 as
follows:

e Proportion of alerts acknowledged within deadline
e Proportion of alerts completed within deadline

You will of course be aware that compliance with safety alerts also had prominence
in both the Francis review into failings that took place in Mid Staffordshire NHS
Foundation Trust and in the subsequent Berwick report ' A promise to learn — a
commitment to act’, as follows:

« Francis Recommendation 41 set out as follows:

“The Care Quality Commission should have a clear responsibility to review
decisions not to comply with patient safety alerts and to oversee the
effectiveness of any action required to implement them. Information-sharing
with the Care Quality Commission regarding patient safety alerts should
continue following the transfer of the National Patient Safety Agency's
functions in June 2012 to the NHS Commissioning Board.”

e The Berwick Report recommended that the CQC should hold Boards
responsible for ensuring that recommendations from patient safety alerts are
implemented promptly while NHS England should complete the re-design and
implementation of a patient safety alerting system for the health care system in
England. Finally, it was recommended that the CQC. should assure that
organisations respond effectively to these alerts except in the rare
circumstances where organisations can demonstrate that implementation of
an alert is not in the interests of specific patient groups.

The CQC responded to both of these recommendations in ‘Hard Truths’, the
Government's response to Francis, as follows:

e¢ The CQC already monitors compliance with patient safety alerts, such as
those issued by the Medicines and Healthcare products Regulatory Agency,
and is able to investigate further where it identifies the need to do so in order
to hold providers to account for failures to act on them.

3. Steps being taken by the CQC to address the concerns set out in your
report.

In response to the recommendations in both the Berwick and Francis reports we are
taking the following actions which also take account of the concerns raise in your
report:

1. The Care Quality Commission ‘is currently exploring how it can give greater
prominence to safety alerts in its revised surveillance and inspection model.
However care is needed to be clear that providers retain accountability for
implementing patient safety alerts. As set out already it is not the currently the

CQC’s role to oversee providers’ individual decisions or actions. Providers
must be able to explain and account for how they act on safety alerts; the
Care Quality Commission's role will be to assess their capability and
performance in terms of whether it results in good quality care.

. In 2013, CQC overhauled its approach to regulation and introduced a new
system of assessment based around the 5 domains of safety, effective, caring,
responsive and well led. This is underpinned by an assessment framework
containing key lines of enquiry and prompts and an Intelligent Monitoring
System of sentinel indicators to help identify risk.

. The CQC also takes account of the work that is being undertaken by NHS
England which has also been working on devising a new system of safety
alerts, with three stages:

o Stage 1: Alert: This alerts organisations to emerging risk. It will be
issued very quickly once a new risk had been identified to allow rapid
dissemination of information.

o Stage 2: Notification: Provision of resources to help mitigate risk
identified in stage 1

o Stage 3: Notification: Directive makes it mandatory for organisations to
have taken actions based on the stage 1 and stage 2 notifications and
implement solutions or actions to mitigate that risk.

The first new alerts under this system were issued in February 2014.

. Compliance with safety alerts (from all sources) features in the assessment
framework and is one of the things CQC inspectors are prompted to consider
when undertaking an inspection. However, the initial version of the Intelligent
Monitoring System did not include an indicator relating to compliance with
safety alerts as the system was largely in abeyance due to the transfer of
safety related responsibilities from the NPSA to NHS England. This has since
been reviewed and from July 2014, a new composite indicator is to be
included in the NHS acute Intelligent Monitoring System pertaining to
compliance with safety alerts. The exact composition is yet to be finalised, but
is likely to include components relating to:

o outstanding alerts of those requiring action in the most recent 12 month
period;

o alerts outstanding for more than 12 months; and

o timeliness of responses to safety alerts in the most recent 12 month
period

. As part of the CQC’s commitment to continuous improvement the registration
process is currently under review to ensure greater robustness of assessment.
The inclusion of specific questions relating to the management of patient
safety alerts is currently being considered as part of this review. Whether or

not registration with a national alerting system should be mandatory across all
health and social care sectors is a topic for wider discussion that is taking
place within the CQC and which would require a change to current legislation.

6. The CQC is also testing some pre-inspection methodology to provide
additional intelligence to inspectors as part of inspection pre-planning and
prior to going on site during the course of an inspection. We are currently
piloting some pre-inspection where we will be testing the dissemination of
safety alerts by assessing provider's policies and procedures around alerts,
and the implementation of a sample of alerts selected on the basis of low
compliance rates on the CAS, or intelligence that alerts have not been well
implemented. By way of illustration we enclose the question/prompts that are
being proposed for inspectors to look for in the providers policy and
procedures documentation, as well as the things to look for during inspection.

We greatly value the intelligence provided by your report and have endeavoured to
address the concerns raised within it. The CQC is currently undertaking a detailed
review designed to ensure that the valuable information provided by Regulation 28
reports, as well as from other sources of information, systematically and effectively
feeds into our intelligent monitoring, inspection and registration processes.

Please do not hesitate to contact us with any further questions.

Yours faithfully

Deputy Chief Inspector — Adult Social Care (South Region and Registration)

ii

LU

ao From Rt Hon Norman Lamb MP
RGR Minister of State for Care and Support

Department

Department of Health
of Health Richmond House
79 Whitehall
London SW1A 2NA
Christopher Dorries
HM Coroner South Yorkshire (West) re G2 SEP 2014
The Medico-Legal Centre a
Watery Street ' 93 SEP 20%
Sheffield :
SS3 7ET

Thank you for your letter to Jeremy Hunt about the death of Lucy Moffatt. | am
responding on his behalf.

| am sorry to hear about the tragic circumstances in this case.

Your report advised that Ms Moffatt had been diagnosed with mental health issues
and, while suffering a reoccurrence of her paranoid schizophrenia, she jumped (or
fell) from a second floor window.

The inquest found that there were issues with the restrictors used on the windows at
the facility and you subsequently raised several concerns about the windows at the
Crisis house, which include the following:

. The type of window restraint can appear secure when it is not actually
locked.

° The lock can be ‘defeated’ by a pair of scissors — and this may be the case
with similar windows.

° Care Quality Commission (CQC) inspectors had not been made properly
aware of the DH alert on this issue.

The DH alert noted in your report regarding ‘window restrictors that may be
inadequate in preventing a determined effort to force a window open’ was a Health
Technical Memoranda (HTM). HTMs give up-to-date established best practice
advice and guidance to the NHS about specialised building and engineering
technology used in the delivery of healthcare.

When an issue is brought to light and flagged by the Department of Health in an
HTM, | expect appropriate action to be taken by healthcare providers as soon as
possible. The fixtures and fittings used must be fit for purpose and healthcare
providers must ensure that this is the case in all of their buildings. | note that you

if
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Department

' of Health

have written to the Trust concerned and would be grateful to have sight of the
response received.

| also note your concerns about communication between the Department of Health
and the CQC. Officials at my Department have discussed your report with the COC
and considered how the CQC can ensure that these alerts are reaching the
appropriate teams.

The CQC have confirmed that neither the registration assessor nor the inspector in
this case were specifically aware of the Department of Health alert concerning the
strength of window restraints. However, under the current statutory and regulatory
framework the primary responsibility for managing patient safety and ensuring that
such alerts are actioned lies with the provider.

Regulation 16 of the Regulated Activities Regulations states that the registered
person must make suitable arrangements to protect service users and others who
may be at risk from the use of unsafe equipment by ensuring that equipment
provided for the purposes of carrying out the regulated activity is properly maintained
and suitable for its purpose, and used correctly.

The CQC takes into account how this regulation is met during registration and
subsequent inspection. Currently, however, the CQC does not mandate exactly what
systems or equipment should be in place — the responsibility falls on the provider to
ensure that they take account of alerts, such as deciding on the particular window
restrictor to be used.

The CQC is committed to continuous improvement and takes the concerns raised in
your report extremely seriously. As your concerns touch upon the broader question
of the implementation and inspection of Safety Alerts, the CQC will take steps to
improve the implementation of Safety Alerts, including the Department of Health
Alerts.

| hope that this information is useful and | thank you for bringing the circumstances of
Lucy Moffatt’s death to our attention.

NORMAN LAMB