Stephen Coulson

Care Quality

Commission
Care Quality Commission
Citygate
Gallowgate
Newcastle upon Tyne
Dr Rashid Sohal NEL SPA
H.M. Coroner's Office Telephone: 03000 616161
Manchester City Area Fax: 03000616171
PO Box 532
Manchester Town Hall www.cqc.org.uk
Albert Square
M60 2LA

2 February 2018

Care Quality Commission
Health and Social Care Act 2008

8102 34 8 0
| G@SAIZ93Y

Reference number: ENQ1-4529953707

Re: Stephen George Coulson (deceased)

Dear Dr.Sohal

Thank you for the Regulation 28: Report to Prevent Future Deaths dated 14
November 2017 regarding Mr Stephen George Coulson (deceased). Your letter has
been forwarded to me for response as | have regulatory responsibility for acute
health care in the north west of England.

In your report, you raised concerns regarding the care of Mr Stephen George
Coulson at Manchester Royal Infirmary on the 30 and 31 December 2015, prior to his
unfortunate death on 1 January 2016. In particular, you were concerned about:

the system in place for the administration, documentation and audit processes
associated with the use of controlled drugs

the lack of escalation of the need to admit patients for observation and review
should they fulfil the criteria to require continued observation or review prior to
discharge, and

the high level investigation with particular concern that the witness did not
accept that any lessons could be learnt from the investigation surrounding the
death of the deceased

| would like to thank you for bringing these matters to our specific attention.

As you are aware, Manchester Royal Infirmary is part of Manchester University NHS
Foundation Trust Central (formerly Manchester NHS Foundation Trust). This NHS

trust became a new legal entity on 1 October 2017. It is registered with the Care
Quality Commission (“the Commission”) to provide regulated activities in accordance
with the Health and Social Care Act 2008.

Manchester Royal Infirmary was last inspected on 3 to 6 November 2015 and 26
November 2015. The report was published on 13 June 2016. The overall rating for
the hospital was ‘good.’ There were no regulatory breaches identified regarding
medicines management at that time, which was prior to the death of Mr Coulson.

A requirement of registration is that organisations notify the Commission about
certain changes, events and incidents that affect their service or the people who use
it. NHS trusts can send most types of notification through the National Reporting and
Learning System (NRLS). This includes incidents resulting in serious harm or death.
However, the NRLS does not contain person identifiable information and we are not
able to confirm if, and when Mr Coulson’s death was reported to the Commission. We
do monitor trends and mortality data and include these in regular engagement
meetings with the Trust.

| will now respond to each of the concerns raised within the Regulation 28 report and
action the Commission has taken in response to these.

1. Controlled drugs - the system in place for the administration,
documentation and audit of processes associated with the use of
controlled drugs.

As you are aware, the Trust have a controlled drugs policy in place. The pharmacy
team within the Commission has reviewed this policy. The policy is of an acceptable
standard, with some suggestions for improvements, such as making it clear who has
responsibility for investigating medicines incidents, which occur outside of pharmacy.
We will share these with the trust.

The policy was updated in November 2017 to include reference to an opioid patch
monitoring form. The use of the form should minimise the risk of a similar incident
experienced by Mr Coulson being repeated. The trust managers have informed the
Commission that they plan to audit implementation of the form. We will monitor this
through our quarterly engagement meetings and subsequently consider this at the
next inspection, which is likely to take place between October and December 2018.

The trust must also have in place a controlled drug Standard Operating Procedures
(SOPs). We will review these as part of our ongoing engagement with the trust. For
your information, we have recently implemented a system of having a named
pharmacist inspector who has responsibility for the Trust and who meets with the
head pharmacist. They are aware of this Regulation 28 report and will include this as
part of their next meeting.

2. Observation policy — the lack of escalation of the need to admit patients
for observation and review should they fulfil the criteria to require
continued observation / review prior to discharge.

As you are aware, the Trust has an observation policy in place. The most recent
version is dated June 2017. This includes the policy statement that observations
must be recorded on the day of discharge home. There is also an associated early
warning score policy that supports escalation to more senior or medical staff for
review.

During the inspection in 2015, it was noted that staff monitored patients by using an
electronic early warning score system that automatically notified medical staff

and some non-medical staff (such as the surgical lead pharmacist) if there was
deterioration in a patient's medical condition. This process was considered to be fully
embedded across the main site and all the staff we spoke with were positive about
using this system.

That said, we will ensure that the use of the early warning score and escalation is
considered at the next inspection. We will also continue to monitor through our
quarterly engagement with the Trust.

3. High Level Investigation — the witness did not accept that any lessons
could be learnt from the investigation surrounding the death of the
deceased.

In light of the Regulation 28 report, the Commission obtained the revised action plan
regarding this tragic incident, which has been submitted directly to you. This does
now identify a number of lessons for the Trust.

As with other significant concerns, we will monitor the action plan through our regular
quarterly engagement meetings with the Trust. We will also take into account the
action plan and the implementation of these actions at the next inspection.

In addition, in light of the Regulation 28 report, we have also considered whether
there is sufficient evidence to take further regulatory action regarding this matter. We
have concluded, based on the information we currently hold, that there is no
evidence there is a systemic issue. However, please be assured we will continue to
monitor the issues you have raised from a regulatory perspective and use the
information to inform future regulatory activity at the Trust.

| hope my response has been helpful in outlining the response of the Commission to
the Regulation 28 report.

If you have any questions about this letter, you can make contact through our
National Contact Centre using the details below:

Telephone: 03000 616161
Email: Enquiries@CQC.org.uk

Write to: Care Quality Commission
Citygate
Gallowgate
Newcastle upon Tyne
NE1 4PA

It is helpful to have the reference number (above) to hand. This will help avoid any
delays in responding to you.

Yours sincerely

=
if

Nicholas Smith
Head of Hospital Inspections (North West)

England

6th floor
Skipton House
80 London Road

Dr Rashid Sohail London
HM Coroner's Office, SE1 6LH
Manchester City Area,

PO Box 532 Business manager email:
Manchester Town Hall, kathyosborn@nhs.net
Albert Square,

M60 2LA 24 January 2018
Dear Dr Sohail,

Re: Regulation 28 Report to Prevent Future Deaths — Stephen Coulson (died 01.01.2016)

Thank you for your Regulation 28 Report dated 27 October 2017 concerning the death of Mr
Coulson on 1" January 2016. Firstly, | would like to express my deep condolences to Mr
Coulson’s family.

Following the inquest you raised concerns to NHS England regarding
- The use, documentation and audit of controlled drugs,
- The Trust's observation policy for patients using controlled drugs and
- The high level investigation itself.

All NHS Trusts must have a Controlled Drug Accountable Officer (CDAO). This person would be
a senior manager within their organisation but who does not routinely supply or handle controlled
drugs themselves. The roles and responsibilities of CDAOs, and the requirement to appoint

them, are governed by the Controlled Drugs (Supervision of Management and Use) Regulations

2013.

As we understand the Trust's initial response did not include engagement with their Controlled
Drug Accountable Officer. We recognise that there was a lack of engagement with the relevant
personnel regarding this incident. We are pleased to learn that the Trust’s revised response
does now include an action plan which is a good indication that lessons have been learnt about
the vital role CDAQs play in reference to controlled drugs.

The Trust has now implemented an extensive action plan, they have:

e Updated the Trust Controlled Drug Policy to include reference to the Opiate Patch
Monitoring Form to ensure that the clinical team are aware of the opiate patches worn
and administration date.

e Update the Opiate Patch Monitoring Form to ensure it is explicit that opiate patches worn
on admission are recorded and that removal of any opiate patch is documented and
signed for by a registered nurse.

e That patient observations are recorded a minimum of 12 hourly in addition to routine
observations. This will be audited to ensure compliance.

High quality care for all, now and for future generations

e Amend Nursing admission documentation within surgery to include the questions to all
patients to check if they are wearing an opiate patch and what dose this is.

e Develop and deliver further education around assessment and treatment of delirium

e Undertaken further education in relation to neurological assessment and completing
physiological observations if a patient has a new confusion

e Implement teaching on new starters induction, mandatory training and 3 yearly acute
illness training regarding when to undertake neurological assessment and escalation of
deterioration

e Implement a new electronic neurological observation chart. The above will ensure any
alteration in patient physiology specifically in any alteration in neurological status.

e Include clinical scenarios involving the prescribing of fentanyl patches and appropriate
dose increases and monitoring requirements in doctors education. Educate regarding the
appropriate dosing of patches as opposed to other routes.

The CDAO at the Trust reports controlled drug incidents into the Greater Manchester Controlled
Drug Incident Reporting system which they investigate and where applicable share the lessons
learnt. This system is being rolled out across England with the prime object to share good
practice and implement lessons learnt. A newsletter will be shared with prescribers and nursing
staff across Greater Manchester to highlight the issues above in the Trust’s action plan.

NHS England will recommend to all Controlled Drug Accountable Officers in each locality to
remind the Controlled Drug Accountable Offices of Designated Bodies to ensure they are
actively involved in providing evidence at the Coroner's Inquest.

Thank you for bringing this important patient safety issue to my attention and please do not
hesitate to contact me should you need any further information.

Yours sincerely, Y C.
L SA

Dr Arvind Madan
Director of Primary Care and Deputy Medica! Director
NHS England

High quality care for all, now and for future generations