Prevention of Future Deaths reports · 2020

Wayne Millett

Regulation 28 report to prevent future deaths, reference 2020-0031, written 18 Feb 2020. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report18 Feb 2020
Reference2020-0031
DeceasedWayne Millett
CoronerChristopher Morris
Coroner areaManchester South
CategoryAlcohol, drug and medication related deaths · Hospital Death (Clinical Procedures and medical management) related deaths · Mental Health related deaths
Sourcejudiciary.uk record · original PDF
Responses published1

The report

Text recovered by OCR from a scanned PDF. OCR is imperfect: check anything you rely on against the source PDF. Reproduced verbatim, including the scan's own layout.

REGULATION 28 REPORT TO PREVENT FUTURE DEATHS
THIS REPORT IS BEING SENT TO: Mr Trevor Torrington, Chief Executive Officer, The Priory Group.

CORONER

| ah Chris Morris, Area Coroner for Greater Manchester South. |

CORONER'S LEGAL POWERS

| make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and
regulations 28 and 29 of the Coroners (Investigations) Regulations 2013.

http://www .legislation.gov.uk/ukpga/2009/25/schedule/5/paragraph/7
http://www.legislation.gov.uk/uksi/2013/1629/part/7/made

INVESTIGATION and INQUEST

On 5" June 2019, | opened an inquest into the death of Wayne Lee Millett, who died at The Priory
Hospital, Cheadle on 13" February 2019, aged 46 years. The investigation concluded at the end of
the inquest, which was heard from 3 to 10" February 2020, before a jury.

A post mortem examination determined Mr Millett died as a consequence of:
1)a) Acute Lung injury

b) Aspiration

c) Pseudo-obstruction of Small bowel most likely due to Clozapine Toxicity.

The jury concluded Mr Millett’s death was drug-related, on the basis that complications of
therapeutic use of the prescribed medication Clozapine set in motion a chain of events leading to his
death.

CIRCUMSTANCES OF THE DEATH

Mr Millett had a long history of mental health problems and was a detained patient at The Priory
Hospital, Cheadle pursuant to a s37 Mental Health Act 1983 hospital order made by the court.

Mr Millett had been diagnosed with paranoid schizophrenia, which proved refractory to treatment.
As such, in conjunction with support and non-medical therapies, the mainstay of Mr Millett’s
treatment was the anti-psychotic medication Clozapine. The court heard evidence that Clozapine is.
reserved for treatment-resistant schizophrenia in the main, as a result of the nature and extent of
side effects which can be associated with its use. In Mr Millett’s case, the administration of
Clozapine was endorsed by an independent second-opinion doctor.

Amongst other things, Clozapine has been associated with a range of gastro-intestinal side effects,
ranging from constipation through to more serious problems leading to paralysis of the gut, bowel
obstruction, and necrosis of part of the bowel.

In 2015 having become acutely unwell, Mr Millett was admitted to an NHS hospital where he was
diagnosed with a paralytic ileus / pseudo-obstruction which was thought may have resulted from
Clozapine use. As a consequence of this, upon his return to the Priory, a care plan was developed to
seek to promote bowel motility, facilitate early identification of serious gastro-intestinal side effects
of Clozapine, and to enable Mr Millett to receive prompt emergency treatment if clinical suspicion of
bowel obstruction arose (“the Care Plan”).

Whilst Mr Millett often complained Oh aidiominal symptoms, there was an escalation in these from
11" February 2019. Notwithstanding this, the Care Plan was not followed, and Mr Millett became
increasingly unwell leading to his collapse and death on 13" February 2019.

CORONER’S CONCERNS

During the course of the inquest the evidence revealed matters giving rise to concern. In my opinion
there is a risk that future deaths will occur unless action is taken. In the circumstances it is my
statutory duty to report to you.

The MATTERS OF CONCERN are as follows. —

1) The Priory’s own investigation into the circumstances of Mr Millett’s death was notably
lacking in meaningful critical analysis of the care and treatment he received, and in
particular was fundamentally flawed in that it failed to consider the care given as against the
Care Plan despite its obvious central relevance to his death.

2) The above concern, when taken in conjunction with the facts that:

a) the evidence before the court confirmed the organisation’s Director of Risk
Management, EM bad input into the investigation; and

b) the Peripatetic Director of Clinical Services who gave evidence before the court was
unable to describe any overarching quality assurance process operating within the
organisation in respect of serious incident investigations;

This raises significant concerns as to the Priory Group’s ability to learn from serious clinical
incidents and to take action accordingly, thus creating a risk of future deaths.

3) The court heard differing evidence from staff working at The Priory Hospital, Cheadle and
from the Peripatetic Director of Clinical Services as to what the organisation’s expectations
were in respect of care plans, and specifically the degree of adherence which were required
to them. In the light of this significant divergence of opinion, it is a matter of concern that
the Priory Group has not undertaken any audit of compliance with care plans (either at The
Priory Hospital, Cheadle or more generally within the organisation) as a result of Mr Millett’s
death,

4) It is a matter of concern that, notwithstanding the cause of death identified on Post Mortem
Examination and despite nearly a year having passed since Mr Millett’s death, the
organisation has yet to formally review the care plans of all patients prescribed Clozapine,
with a view to ensuring each relevant patient has in place a clear plan for monitoring of

potential side-effects of the medication, which gives clear and authoritative direction to staff
as to how to act if serious complications are suspected. It is a particular matter of concern
that this step has not been taken, given the evidence heard from the Peripatetic Director of
Clinical Services which suggested this would be a straightforward measure to accomplish,
and one which could be completed within 28 days.

ACTION SHOULD BE TAKEN

In my opinion action should be taken to prevent future deaths and | believe you and your
organisation have the power to take such action.

YOUR RESPONSE

You are under a duty to respond to this report within 56 days of the date of this report, namely by
14" April 2020. |, the coroner, may extend the period.

Your response must contain details of action taken or proposed to be taken, setting out the
timetable for action. Otherwise you must explain why no action is proposed

COPIES and PUBLICATION

| have sent a copy of my report to the Chief Coroner and to Mr Millett's brother, i I

have also sent a copy of my report to a who represented the
Priory Group at the inquest.

| have also sent it to the Care Quality Commission, the Regional Medical Examiner for North West
England, and Salford CCG (as commissioners of Mr Millett’s care)

lam also under a duty to send the Chief Coroner a copy of your response.

The Chief Coroner may publish either or both in a complete or redacted or summary form. He may
send a copy of this report to any person who he believes may find it useful or of interest. You may
make representations to me, the coroner, at the time of your response, about the release or the
publication of your response by the Chief Coroner.

Dated: Ty 2020

Signature:

Tr, Manchester S

Responses

1 response published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.

Response from Priory (PDF)
,. 

Friday 5 June 2020 

Your reference: 12296/MH 

By email: 
coronersmanchestersouth@ukemail.icasework.com 

Hard copy to: 
Mr Christopher Morris 
HM Area Coroner 
Coroner's Court 
1 Mount Tabor Street 
Stockport,  SK1  3AG 

Dear Mr Morris 

Re. Wayne Lee Millett 

P :::,yo  :::,•y  OROUP OF 

"-1. 

COMPANIES 

' 

Trevor Torrington 
CEO, Priory Group 
80 Hammersmith Road 
London, W14 BUD 

'(jlj)~~ 

11•JUN  2020 

HM  CORONER 
MANCHESTER SOUTH 

I am writing in response to the Regulation 28 Report dated 18 February 2020 issued following the Inquest touching 
the death of Mr Wayne Lee Millett. 

Thank you for permitting an extension in respect of providing a reply in light of the very challenging circumstances 
presented by Covid-19.  We have now had time to give due consideration to the concerns raised and our response 
is provided as per the below. 

Our investigation 

We acknowledge that greater emphasis should have been given  to analysing the care plan in place for Mr Millett 
to include the staff's knowledge and understanding of it and that there was a gap between the prescriptive nature 
of the care plan and staff's adherence to it. 

We would ask you to please note that: 

• 

• 

• 

• 

The SUI report and 
a long-term patient who had been at the hospital since November 2013 was of an acceptable standard. 

report convey that overall, the care and treatment provided by staff to Mr Millett, 

The care plans themselves were of an acceptable standard and were regularly reviewed. 

As you rightly  point out,  Mr Millett often had bouts of abdominal discomfort and prior to the incident, these 
episodes were managed successfully including through the administration ofMovicol. As such, from a practical 
perspective, staff were managing the risk on a day-to-day basis in accordance with good clinical practice. 

At the time the investigation was carried out and the report completed, the investigators were not aware of the 
cause of death as they had not seen the PME report. 

You will also appreciate that given the nature and timing of an incident investigation and a coronial inquiry, there is 
sometimes a "mis-match" between the findings of a SUI report and an inquest and even experienced investigators 
often consider post-inquest - with the benefit of hindsight - that they could have looked at certain matters in more 
detail or with greater emphasis. 

A  learning organisation 

In relation to your concern  that we are not a learning  organisation,  please note we continue to invest significant 
time and resource in making continuous improvements to the services we provide to some of the most clinically 
challenging mental health patients in the UK. This includes in relation to incident investigations: in March this ye ar, 
we  recruited  a  highly-experienced  serious  incidents  investigation  officer  (SIO)  with  a  clear  mandate  to  make 
improvements to our processes for the benefit of patients and staff including: 

1 

 .. 

• 

Ensuring  that all  SUI  reports are completed within  60 days with  the  full  involvement of all  stakeholders 
including relatives and family members; 

•  Delivering training  to  senior staff who are commissioned  to  complete  investigations and  prepare reports 
to ensure they have the necessary skills to identify key  issues and convey those concisely and clearly in 
their written outputs; 

• 

• 

Strengthening the  review  process so  that all  draft serious incident investigation reports are reviewed  by 
a team of senior staff which in all cases includes the Group Medical Director and the Director of Quality. 

Ensuring that action plans are drawn up  based on the recommendations  in the SUI  report and these are 
monitored regularly by senior staff at site to ensure learnings are being embedded in clinical practice. 

More  generally  in  relation  to  incidents,  we  have  systems  and  processes  in  place  to  ensure  we  learn  from  all 
incidents and near misses as expeditiously as  possible.  In July 2019, we invested in  a new incident reporting  tool 
(Datix)  which  has  assisted  us  to  report  incidents  more quickly and  better analyse them  both  locally  i.e.  at  each 
hospital and across the Healthcare Division as  a whole. 

In the event of a very serious incident, we always undertake a rapid review of the case with the aim of taking swift 
action,  where  it  is deemed  necessary,  to  help  reduce  the  possibility of a re-currence  of such  incidents and  until 
such time as the completion  of the more  detailed  investigation.  We circulate frequent  bulletins  and messages to 
our staff about the lessons learnt from incidents and  near misses with  policies and training courses amended and 
updated  accordingly.  The  implementation  and  embedding  of  any  improvement  actions  is  monitored  by  our 
Healthcare  Division  Quality  Team  who  scrutinise  incidents themes  and  trends  and  where  necessary  undertake 
more individualised reviews of patient care. 

Auditing compliance with patient care plans 

Please  note  there  are  systems  in  place  which  ensure  that  patient  care  plans  are  regularly  audited.  These 
systems  include  Ward  Managers  and  the  Director  of  Compliance  at  each  hospital  having  a  responsibility  for 
undertaking  regular "spot-checks" by way of completing the monthly Quality Walk  Rounds during which  the care 
records  of patients are reviewed  and  evaluated.  Our Healthcare  Division  Quality Team also undertakes a formal 
annual  audit  of care  plans.  The  2020  audit  was  unfortunately  delayed  due  to  the  Covid-19  pandemic  but  was 
completed last month with  the audit results  currently being analysed. 

Patient Clozapine care plans 

As above, we are very much  a learning organisation and we  saw the matters raised at the Inquest concerning  Mr 
Millett as  an  opportunity to  review the way  in  which we  manage  the  prescription  and  management of Clozapine. 
We have  now allocated  a  Clozapine  learning  and  development  module  to  all  doctors  and  qualified  nurses.  We 
have  also  issued  Clozapine  guidelines and  an  associated  care  plan  "template"  which  gives clear details on  the 
potential side-effects of the medication and how best to manage those. 

I trust that the actions outlined above will provide the assurances you seek in  respect of this matter. 

Yours sincerely, 

Trevor Torrington 
Chief Executive Officer 
Priory Group 

2

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