Prevention of Future Deaths reports · 2019

John Mellor

Regulation 28 report to prevent future deaths, reference 2019-0053, written 14 Feb 2019. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report14 Feb 2019
Reference2019-0053
DeceasedJohn Mellor
CoronerNicholas Flanagan
Coroner areaManchester North
CategoryHospital Death (Clinical Procedures and medical management) related deaths
Organisation namedPennine Care NHS Foundation Trust · Pennine Acute Hospitals NHS Trust · Salford Royal NHS Foundation Trust
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 (1)

REGULATION 28 REPORT TO PREVENT FUTURE DEATHS
THIS REPORT IS BEING SENT TO:
1. Dr John Patterson, Chief Clinical Officer - Oldham Care Commissioning Group
2. Sir David Dalton, Chief Executive — Northern Care Alliance NHS Group
3. I st Chad's Medical Practice, Lime Green Parade, Oldham
4, Ms Claire Molloy, Chief Executive - Pennine Care Foundation Trust
CORONER

lam Nicholas Flanagan , Assistant Coroner for the Coroner area of Manchester North

+

CORONER’S LEGAL POWERS

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

INVESTIGATION and INQUEST
On the 12" October 2018 I commenced an investigation into the death of John Andrew Mellor

CIRCUMSTANCES OF DEATH

John Andrew Mellor suffered from diabetes mellitus, chronic kidney disease and deep vein
thrombosis, which had previously caused cerebrovascular accidents and required warfarin therapy.
He was under the care of his GP, as well as specialist teams, particularly the Department of Renal
Medicine at Salford Royal Hospital.

On the 10° August 2018 he attended the Renal Medicine outpatient clinic, where he was
commenced on Erthropoietin (EPO) treatment due to acute anaemia. Salford Royal Hospital sent a
letter to Mr Mellor on the 10 August 2018, with a copy sent to his GP, asking him to arrange Full
Blood Count tests with his practice nurse or district nurse around the 24" August 2018 and every
two weeks thereafter. Mr Mellor made extensive efforts to have his blood tested, however his GP
practice stated they did not have capacity to undertake the tests and the District Nursing Team
indicated that as he was not house bound, they would not perform the tests. Mr Mellor was
eventually able to have his blood taken and tested at the Royal Oldham Hospital on the 24"
August.

On the 31* August 2018, a further letter was sent by Salford Royal Hospital to Mr Mellor, although
this letter was not copied in to his GP. The letter informed him that he was due to have a Full Blood
Count, among other tests and that he should take the letter to his GP or come to the clinic in
Salford if he had an appointment. The letter told Mr Mellor to mark the samples for them to be
returned to the Renal Medicine Department.

Mr Mellor was not due to be seen by the clinic for some time. All attempts made by Mr Mellor or his
representatives to have his blood tested by his GP, the District Nurses or Royal Oldham Hospital
proved unsuccessful, with each agency indicating it was not their responsibility. Mr Mellor was
constantly passed between agencies. There were insurmountable difficulties, for practical, financial
and health reasons, with Mr Mellor attending Salford Royal Hospital from his home address to have
his blood tested fortnightly. Due to the absence of blood tests, Mr Mellor was advised not to
administer the EPO.

Mr Mellor continued to have his INR levels checked throughout August and September 2018,
indicating normal INR levels. On the 27" September, Mr Mellor attended a clinic in Salford, his
blood was tested and results the following day revealed a very low blood count requiring an urgent
transfusion. Mr Mellor was contacted, but he collapsed at home on the morning of the 28"

September and was taken to the Royal Oldham Hospital. Despite extensive treatment, his
condition deteriorated and he died on the 3° October 2018.

The Inquest established the cause of death as:

1a End Stage Renal Failure

1b Diabetic Neuropathy

2 Upper Gastrointestinal Bleed, Anti-Coagulation Therapy, Deep Vein Thrombosis.

The inquest could not establish whether the failure to administer the EPO caused or contributed to
Mr Mellor’s death.

The Inquest heard evidence from the Next of Kin and General Practitioner, which detailed the
unsuccessful steps that were taken to obtain a blood sample, as well as contemporaneous notes of
the communication between agencies at the time. The GP has since sent a letter to the local Care
commissioning Group, Dr Patterson, relating to his concerns regarding deficiencies in the care
interface.

The Conclusion of the Inquest was:

Natural causes to which the known side effects of necessary anti-coagulation therapy more
than minimally or trivially contributed.

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:-

That there appears to have been a systematic failure to ensure that blood tests are conducted,
where required, for individuals under specialist, secondary care for renal failure. Individual patients,
who may not be local to the specialist centre, will inevitably fail to have the appropriate
assessments, care and treatment, in the absence of a clear line of responsibility.

The failure to establish a shared care arrangement, or at least to ensure that an organisation was
identified in order to undertake blood sampling for drug monitoring, is insecure and unsafe.

It is also concerning that responses or updates to referrals, as well as requests for tests in the
community, have not been communicated to primary care directly, with the sole reliance on a
patient to pass vital documentation on to his primary healthcare provider.

|

ACTION SHOULD BE TAKEN

In my opinion action should be taken to prevent future deaths and | believe each of you respectively
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 12" April
2019. !, 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 the following Interested Persons namely:-

1. Dr John Patterson, Chief Clinical Officer - Oldham Care Commissioning Group
2. Sir David Dalton, Chief Executive — Northern Care Alliance NHS Group

3. HM st Chad's Medical Practice, Lime Green Parade, Oldham

4. Ms Claire Molloy, Chief Executive - Pennine Care Foundation Trust
iii acting Next of Kin

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 from. 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.

9

Date: 14" February 2019 Signed: N M Flanagan

OG oon

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 S (PDF)
Saving lives, NHS

Improving lives Northern Care Alliance
——-— NHS Group

Salford | Oldham | Bury | Rochdale | North Manchester

Ref: JS/SJB: _ Chief Officer
2" Floor |

Date: 11" April 2019 Mayo Building

Stott Lane

Salford

M6 8HD

Telephone: 0161 206 3178

Dear Sir
Inquest touching the death of John Mellor

| write in relation to the above inquest which was held before you on 13 February 2019.
Following the inquest you issued a Regulation 28 report. Box 1 of this report addresses it to
Sir David Dalton, Chief Executive of the Northern Care Alliance Group (“NCA”) (amongst
others).

Firstly, thank you for bringing the concerns raised in the Regulation 28 report to our
attention. | ‘would like to take this opportunity to provide assurance to both you and the
family that Salford Royal Care Organisation (“SRFT”) takes the concerns raised very
seriously and action has been taken to address these as detailed below.

As you are aware, Pennine Acute Hospitals NHS Trust (“Pennine Acute”) was considered
an Interested Person and witnesses from Pennine Acute gave live evidence.

You also heard evidence from SRFT. by way of a single statement read under Rule 23.
SRFT were not given Interested Person status at the inquest and therefore did not attend.
SRFT would have welcomed the opportunity to give evidence to your inquest to explain the
steps that had already been taken to address the concerns that you have raised. SRFT first
became aware of the Coroner's concern following receipt of the Regulation 28 report.

| would like to take this opportunity to apologise to Mr Mellor’s family that the inquest
process has been extended through the Regulation 28 process.

Discussions have taken place with representatives from Oldham Care Commissioning

Group (“CCG”), St Chad’s Medical Practice and Pennine Care Foundation Trust. Cross-
organisation learning has been shared and we are assured that there is now a robust

OE —

Saving lives, . NHS

Improving lives Northern Care Alliance
nn i aa NHS Group

Salford | Oldham | Bury | Rochdale | North Manchester

tracking “system within SRFT for patients requiring Erythropoietin Stimulating Agents
(“ESA”) treatment and monitoring their bloods. Erythropoietin (“EPO”) is a specific hormone
that falls into the ESA drug group.

Regulation 28 concerns and response:

- Systematic failure to ensure that blood tests are conducted, where required,
for individuals under specialist, secondary care for renal failure. Failure to
establish a shared care arrangements, or at least ensure that an organisation
was identified in order to undertake blood sampling for drug monitoring is
insecure and unsafe.

Following discussions with the CCG, it is recognised that this is a Greater Manchester
issue. |

SRFT has looked at both immediate actions and long-term solutions to address the
concerns raised and the lessons that have been learned will be shared with the Renal
Patient Safety Committee which is a joint venture with the British Renal Society. The Renal
Patient Safety Committee works closely with the Medicines and Healthcare products
Regulatory Agency (MHRA) and NHS Improvement and aims to minimise avoidable harm
to patients with kidney disease.

Immediate actions to assure patient safety

The wording of letters to patients has been modified to ensure the options available to them
for arranging blood tests is very clear and a point of contact at SRFT is provided if the
patient is having any difficulty. Patients may attend the renal clinics at Salford, Wigan,
Bolton and Oldham for pre-arranged blood tests.

Prior to commencement of treatment, a letter is now sent to the patient's GP when the
Renal Consultant is considering ESA treatment to make the GP aware of this and to ask if
they are able to monitor the patient’s bloods. A returns slip is included so that this can be
completed and administrated efficiently. When SRFT are aware of the GP’s position in
respect of the patient’s bloods, an appropriate blood monitoring plan is agreed with the
patient at the time of the prescription of ESA. This method enhances the informed consent
process for ESA treatment as the patients will have an understanding of the full implications
of the monitoring required. SRFT’s Electronic Patient Record System (“EPR”) has been
updated with a section confirming when a GP has responded in respect of monitoring. If no
response is obtained from primary care, this is followed up by the renal clerical team.

ODE  ———E—EE

Saving lives, INHS|

Improving lives Northern Care Alliance
nant : NHS Group

Salford | Oldham | Bury | Rochdale | North Manchester

Until SRFT receives a response from the GP, we assume responsibility for taking bloods to
ensure that patients start ESA treatment when clinically necessary.

A Standard Operating Policy has been developed which describes the above process and
the steps taken when a negative response is received, or when a response is outstanding.
A copy of the Standard Operating Policy is attached.

In order to track all patients receiving ESAs, SRFT’s EPR system has been updated to
show when patients’ blood results are due, and those that are missing and require follow
up.

Prescribers have allocated time, in their job plans for ESA monitoring and prescribing. The
new EPR system always shows the most recent haemoglobin results for the patient.

These improvements will provide assurance not only in respect of new patients who start
ESA treatment, but also current patients. All- patients currently receiving ESA treatment will
be written to by the renal admin team by the end of May 2019 to establish whether they
have experienced any difficulties in accessing appropriate monitoring. Patients
experiencing difficulties will be managed in accordance with the agreed SOP.

Long-term plan

Patients under the care of SRFT renal services often do not live locally to the renal unit so if
monitoring is required to be undertaken at SRFT, this is often not the best or most
appropriate solution. Previously, there was no agreement or shared care protocol in place
between SRFT and its CCG catchment primary care providers for the monitoring of bloods.

As above, following discussions with the CCG, it is recognised that this is a Greater
Manchester issue. We are exploring via CCGs and the Greater Manchester Medicines
Management Group the possibility of a Greater Manchester commissioned shared care
protocol for monitoring of ESAs.
- Responses or updates to referrals, as well as requests for tests in the
community have not been communicated to primary care directly.

A Rapid Review has been completed to ensure all lessons to be learned from this incident
have been identified and to ensure the learning can be embedded.

The Rapid Review included a thorough review of the timeline of correspondence ‘sent to Mr

Mellor’s GP. | apologise unreservedly on behalf of SRFT for any perceived shortfalls in ;
respect of SRFT’s communication to Mr Mellor's GP. :

en

Saving lives, NHS

Improving lives Northern Care Alliance
Se NHS Group

Salford | Oldham | Bury | Rochdale | North Manchester

Going forward, GPs will be copied in to all correspondence to the patient, including
correspondence advising the patient that they are due to have their bloods tested.

Next steps

| trust that this response provides assurance that lessons have. been learned from this case
and demonstrates the improvements that have been made to systems at SRFT.

| would like to conclude by once again apologising to Mr Mellor’s family for the issues in his
care that have been identified above and that the Inquest process has been extended
through the Regulation 28 process. We would have- much preferred to have had the
opportunity to explain this in person at the Inquest. | would wish to offer my deepest
condolences to Mr Mellor’s family on their loss.

Please do not hesitate to contact me if you require any further information.

Yours sincerely
\

Chief Officer

Salford Royal NHS Foundation Trust

Northern Care Alliance NHS Group

Comprising Salford, Bury and Rochdale,

Oldham and North Manchester Care Organisations

NHS
Oldham
Clinical Commissioning Group

If calling please ask for: John Patterson Ellen House
Direct line: Waddington Street
Email! Oldham

, OL9 6EE

0161 622 6400
w. www.oldhamccg.nhs.uk

11 April 2019

Nicholas Flanagan

Assistant Coroner

Manchester Area

Office of HM Coroner

The Phoenix Centre

L/Cpl Stephen Shaw MC Way (formerly Church Street)
Heywood

OL10 1LR

Dear Mr Flanagan
Re: John Mellor — DOD 3" October 2018

Further to your Regulation 28 report of 14" February 2019 following the inquest into the death of Mr
Mellor on 12" October 2018, | confirm that a full investigation into the matters you raised has been
completed by the care organisations responsible for the care of Mr Mellor. | am now ina position to
respond to the concerns raised into the circumstances surrounding the death of Mr Mellor. The
matters of concern raised and the actions we will take to address these concerns are as follows:

1. That there appears to have been a systematic failure to ensure that blood tests are
concluded, where required, for individuals under specialist secondary care for renal
failure. Individual patients, who may not be local to the specialist centre, will inevitably
fail to have the appropriate assessments, care and treatment in the absence of a clear
line of responsibility.

2. The failure to establish a shared care arrangement, or at least that an organisation was
identified in order to undertake blood sampling for drug monitoring, is insecure and
unsafe.

3. ‘It is also concerning that responses or updates to referrals, as well as requests for
tests in the community have not been communicated to primary care directly, with the
sole reliance on a patient to pass vital documentation on to his primary healthcare
provider.

The investigation has highlighted a number of contributing factors within the care system which
‘oe Mr Mellor accessing the necessary service which is extremely regrettable. There was a

a
Best Care « Best Health « Best Value

lack of systems and processes in place throughout the organisations to ensure follow up, escalation
and effective communication between all agencies involved in Mr Mellor's care. The absence of a
clear line of responsibility within the system was evident within the investigation and demonstrates
the need for a clear shared care pathway with accountability for action to ensure that the patient
receives the appropriate level of care.

In discussion with colleagues across the system it is apparent that there was no one individual
taking responsibility for this gentleman's care, resulting in a level of assumption and an unnecessary
and inappropriate level of responsibility placed on him and his family to be requesting blood tests. In
both the case of the referral to the District Nursing Single Point of Access and the Primary Care
team, it is clear that escalation of the issues to a more senior clinician may have altered the course
of these events and allowed more timely action to be taken. This is something that has been
identified by both the GP Practice and the District Nursing Team and forms part of the learning to
prevent such occurrences in the future.

From a system perspective, there was a missed opportunity for Mr Mellor to have his bloods taken
at the blood lounge at Royal Oldham Hospital whilst he was on the Oldham site for the clinic
appointment. This generates learning about satellite clinics and the awareness of the team as to
what services may be available locally that the clinic can tap into.

The review of the timeline of events with the GP Practice has demonstrated where gaps in
communication have had a significant impact. The failure to copy the GP in to the communication
out to Mr Mellor meant that whilst he was struggling to access a service to take his bloods, the GP
was unaware that this was the case. When this was brought to light, there was an escalation within
the surgery, however this was impacted by existing skills and capability along with annual leave
arrangements. Unfortunately this was not communicated back to the GP themselves and the
investigation clearly recognised this as a missed opportunity.

The CCG instigated a system call to agree actions going forward as a collective, some of which will
be described in greater detail within individual organisational responses.

The actions being led by the Renal Team at Salford Royal Foundation Trust have been to put in
place a standard operating procedure to communicate directly with GP's and ensure a response to
any request for blood monitoring or any other service carried out locally. This will require a response
from the local GP or provider before the treatment plan is confirmed. The Trust have confirmed that
all correspondence with the patient will be copied to the GP. On a longer term implementation is the
development of a shared care model — this has been described in a business case to Greater
Manchester Medicines Management Group which will then go out to local commissioners.

The Pennine Care Foundation Trust District Nursing single point of access service have
implemented a follow up system to make sure that there is a response from the GP practice
following a referral. As a backup measure, where patients have been referred to another part of the
system they are being told that should they encounter any problems they are to come back to the
District Nursing Team who can then intervene on their behalf.

All staff within the GP practice are currently undergoing significant training in escalation and
administrative processes. Common practice is for GPs to provide a phlebotomy service so that the
patients care is close to home. Additional support has been offered by the CCG to ensure that all
relevant staff are trained, up to date and competent to ensure that they can deliver this service.

Learning will be shared across the Northern Care Alliance (NCA) and communicated to Central

Manchester Foundation Trust to ensure that shared care protocols are reviewed and that others can
learn from the communication errors that occurred for Mr Mellor. Oldham CCG have been working

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Best Care * Best Health » Best Value

with the medicines optimisation team to identify all individuals who may be on (or fit the profile of) a
shared care pathway. There have been 43 individuals identified that are currently receiving Epoetin
or Darbepoetin. We have written to each GP practice to share the learning from this investigation
and to ensure they have reviewed any patient that fits these criteria and that there is a robust
monitoring process in place. NCA have also been asked to identify patients and escalate to CCG if
they have any concerns.

We hope that this demonstrates that the CCG has robustly reviewed all aspects of the concerns
raised within the Regulation 28 notice and provides assurances regarding the lessons learned and
the actions taken to prevent reoccurrence in the future.

Please do not hesitate to contact us should you wish to discuss any further concern.

Yours sincerely

ANIA

MA MRCP MRCGP Claire Smith
linical Officer & Deputy Accountable Officer Executive Nurse
NHS Oldham CCG

Best Care + Best Health * Best Value

9" April 2019

Strictly Private and Confidential
Nicholas Flanagan

INHS'

Pennine Care
NHS Foundation Trust

Service/Department Name
Trust Headquarters

225 Old Street
Ashton-under-Lyne
Lancashire

OL67SR

Telephone: 0161 716 3000

Visit us at www.penninecare.nhs.uk

HM Assistant Coroner

H M Coroner's Office

The Phoenix Centre

L Cpl Stephen Shaw MC Way
Heywood

OL10 1LR

Dear Mr Flanagan
Re: John Mellor —- DOD 3" October 2018

| write following the Inquest of John Mellor. Your concerns after hearing all the evidence
have been brought to my attention and | have subsequently reviewed the Regulation 28
letter issued to Pennine Care.

| am writing to respond to the concerns raised into the circumstances surrounding the tragic
death of Mr Mellor. The matters of concern raised and the actions we will take to address
these concerns are as follows:

e That there appears to have been a systematic failure to ensure that blood tests
are concluded, where required, for individuals under specialist secondary care
for renal failure. Individual patients, who may not be local to the specialist
centre, will inevitably fail to have the appropriate assessments, care and
treatment in the absence of a clear line of responsibility.

e The failure to establish a shared care arrangement, or at least that an
organisation was identified in order to undertake blood sampling for drug
monitoring, is insecure and unsafe.

e It is also concerning that responses or updates to referrals, as well as requests
for tests in the community have not been communicated to primary care
directly, with the sole reliance on a patient to pass vital documentation on to
his primary healthcare provider.

| can confirm that a referral was received on 28/8/18 into the Oldham Single Point of Access
(SPoA) for Adult Community Nursing from the Department of Renal Medicine at Salford
Royal NHS Foundation Trust.

The SPoA is a central point of access via telephone or email which provides a gateway to a
range of health services including Adult Community Nursing for patients, carers and

professionals. The service is delivered by nurses who triage and manage the referral
process with the support of administrators.

The referral received did not arrive in the usual format as a recognised referral form and was
more a letter. The letter did not contain all the relevant information required to triage
effectively, for example it was not dated and did not detail if the patient was housebound
which would assist in determining which team the referral would be allocated to. Additionally,
the telephone number that was recorded on our Paris recording system for Mr Mellor was
not in use and there was no patient telephone number documented on the referral therefore
the SPoA requested an up to date contact number from the renal unit for the patient in order
to arrange an appointment.

The Oldham Adult Community Nursing service provides care for patients who are
housebound, either permanently or temporarily, requiring treatment in their own home. There
is also a Treatment Room service based in clinics across the borough for those patients’ not
housebound but requiring District Nursing interventions. The service is commissioned to
deliver a phlebotomy service to housebound patients only.

It was determined from the response received on 29th August 2018 from the Renal Unit at
Salford Royal, confirming Mr Mellor’s contact details that he (Mr Mellor) was not
housebound. It was also identified through the Paris recording system that Mr Mellor was
attending podiatry clinics most weeks therefore the referral was forwarded to the GP practice
for blood pressure monitoring and phlebotomy (full blood count), via email, as is the correct
process for the service. Had Mr Mellor been unable to self-administer his injection he would
have been offered an appointment in Treatment Room clinics for his injection, blood
pressure monitoring and full blood count as is the correct process.

Our records confirm, that the practice manager from Mr Mellor’s GP practice contacted the
West Cluster Integrated Community team (who are aligned to the practice) to ascertain if the
recommendations from SPoA were correct; the duty nurse confirmed this to be the case and
this decision was not questioned or contested.

No further contacts after 31% August 2018 were made to the Adult Community Nursing
service in relation to this referral.

When Mr Mellor was contacted by SPoA on 31* August 2018, previous attempts to contact
him on 29th and 30" August were unsuccessful, he was advised he was being referred back
to his GP practice to undertake the blood pressure monitoring and phlebotomy - full blood
count. An apology was given to Mr Mellor for the misunderstanding. The nurse contacted
the surgery to advise of this conversation with Mr Mellor and confirm to the practice that the
referral was forwarded to them by email on 29% August 2018 when it was identified the
patient was not housebound.

Following the receipt of the Regulation 28 notice a meeting was arranged by the GP
practice. The Cluster Lead and Senior Practitioner from the West Cluster Integrated
Community team attended the meeting that took place on 25" February 2019. GP’s, Practice
Nurse, Practice Manager and an administrator represented the GP practice.

2

Visit us at www.penninecare,nhs.uk

1s,

Both parties reviewed the information and timelines of events in regard to this referral to
determine what collectively we would do differently if similar circumstances arose. It was
determined that based on the information available the SPoA and District Nurses followed
due process and acted accordingly. It was acknowledged at that time the practice did not
have capacity to facilitate the full blood count although they were able to perform the blood
pressure monitoring.

It was acknowledged that there was a lack of understanding from the practice administrator
in relation to the differences between the SPoA and the cluster team; this was addressed in
the meeting. Had the practice staff and cluster team discussed the case a resolution could
have been identified. This could have included Mr Mellor attending Treatment Room for
supervision of this injection alongside blood pressure monitoring and full blood count.
Alternatively, it may have been possible to arrange for Mr Mellor to have his blood taken
whilst he was attending his Podiatry appointments.

It is evident that Mr Mellor’s ability to self-manage part of the treatment plan, (his injection)
resulted in him not receiving the appropriate support to manage his condition safely and
appropriately.

Following this incident and to ensure the learning is communicated, the Cluster Lead is
meeting with SPoA staff to ensure that when referrals are forwarded to another provider that
the patient is informed of the reason for this. Patients will also be advised to contact SPoA
should any issues arise and SPoA staff will then escalate to cluster teams to resolve.

A ‘lessons learned’ poster is being developed to share across community services in support
of this.

Oldham is entering phase 2 of integration having successfully co-located health and social
care community teams around GP clusters to provide a whole system approach to delivering
high quality care in a more joined up way and it is these closer working relationship and links
between providers that will improve communication between members of the MDT.

| hope that the information provided offers assurances in relation to your concerns.

Please do not hesitate to contact me should you require any further information.

Yours sincerely

Clare Parker
Executive Director of Nursing, Healthcare Professionals & Quality Governance

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Mr Nicholas Flanagan
Assistant Coroner (Manchester North)

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Dear Mr Flanagan, ‘e
Re: Inquest concerning Mr John Mellor (deceased)

Thank you for your letter of 14 February 2019 enclosing the Regulation 28 Report for the
Prevention of Future Deaths In light of your Investigation into the death of Mr Mellor. The.report
was also sent tol at Oldham Care Commissioning Group EE at North Care
Alllance NHS Group and Sa at Pennine Care Foundation Trust In addition to St Chads

Medical Practice.

Background

St Chads Medical Practice (“the Practice”) contracts with the Oldham Care Commissioning Group
("the CCG") to provide primary care services to around 3000 registered patients within the
fmmediate surrounding area. The Practice also provides some monitoring of medications
prescribed within secondary care undera series of shared care agreements which are negotiated by

the CCG with Secondary Care,

Prior to early 2018, the majority of the secondary care services provided to patlents registered at
the Practice would be through the Pennine Acute Trust, with some specialist care provided through
Salford Royal NHS Foundation Trust. Renal Services were provided through Salford Roya) NHS
Foundation Trust, which had a satellite clinic at the Royal Oldham Hospital.

At the beginning of 2018 the Pennine Acute Trust and Salford Royal NHS Foundation Trust merged
Into the Northern Care Alliance (“the Trust’).

Separate to this the Pennine Care Foundation Trust provides additional primary care support In the
community, for instance the use of District Nursing.

sags Shas ERNE eRe EASELS Haram ner tester meme tt wn at wantin ese SF

Inorder to compile this response, we have discussed your report and the issues that arose at the
Inquest, not only within the Practice but also with the District Nursing Team and SE at
the CCG. Asa result of those discussions various activities have been arranged by different bodies
and this report seeks to identify those that are relevant to the Practice, rather than those matters
that are concerns for the CCG and the Trust.

The Practice divided the concerns into three areas of urgency,
4. Red: Ensuring that there was no immediate risk to patients within the Practice and alerting

the CCG

LEHICHMLSt

°
Oldham
ags OL8 3HH
Tel: 016 1 620 1611
Medical Practice stchads,medicalpractice@nhs.net

2. Amber; Identifying where action should have been taken at the time
3. Green: Putting In place measures to prevent reoccurrence In the future

We have set out the steps taken by us in this regard below and enclosed a table which sets this out
in more detail.

Ensuring that there was no immediate risk to patients

Ordinarily where Primary Care Services (GP Practices and District Nursing) are asked to arrange for
ongoing monitoring for medication prescribed by secondary care, those medications are amber or
green status drugs under the Greater Manchester Clinical Standards Board for Medicines
(‘GMMMG") Joint Formulary.

EPO (Brythropolesis stimulating medication) is a red status medication under the Greater
Manchester Joint Formulary (GMMMG). Red status medications according to GMMMG are “for
secondary or tertiary care initiation and long-term maintenance of prescribing.”

Amber status medications are described as “drugs which are appropriate to be tnitlated and
stabilised by a spectalist in secondary or tertlary care, once stabilised the drug may be appropriate for
responsibility to be transferred from secondary to primary care with the agreement of a GP anda
formal ‘shared care’ agreement.” The GMMMG publish the approved shared protocols for those
drugs on thefr website which include detalls such as dosage, baseline investigations, ongoing
monitoring, wha Is responsible for the dose adjustments, drugs which must not be prescribed with
the medication, criteria for shared care and the express responsibilities of the Snitlating clinician
and primary care, amongst other criteria.

In addition there are three levels of green status medications which can be prescribed by primary
care without a shared care agreement, they are those that have to be initiated in secondary care but
require little monitoring, those that are prescribed following specialist medication requiring little
monitoring and then drugs which can be instigated, monitored and reviewed within primary care.

Shared care agreements are negotiated between secondary care and the CCG. They are not matters
that are usually negotiated between secondary care and an individual General Practice surgery.
Where the Practice {s individually contacted the appropriate guidance fs “The Interface between
primary and secondary care Key messages for NHS Cliniclans and Managers” (July 2017).

The Practice should have alerted the CCG to the fact that they were being asked to arrange
monitoring of a red status medication so that the CCG could Haise with secondary care and
Medication Management. We wrote to the CCG on 11 February 2019 to notify them of this
significant event and the upcoming Coroner's Inquest. Please find a copy of that letter enclosed with
this response.

Following the Inquest a Practice audit was undertaken on 15 February 2019, which confirmed that
there are no other patients at the Practice under the care of the Renal Team who are currently
prescribed EPO or receiving monitoring. Please find a copy of that Audit enclosed with this
response.

Quiienusoe

e
Oldham
a S OL8 3HH
Tel: 0161 620 16)1
Medical Practice stchads.medicalpractice@nhs.net

During a telephone call with HE at the CCG on 29 March 2019, the Practice was Informed
that we should not agree to the monitoring of red category medications and should notify the CCG
urgently If asked to do so. ‘The CCG are Halsing directly with the Trust and also with Medications
Management regarding this Issue. At the request ye we have not written to the Trust
and the CCG are liaising with them directly in relation to the Issues identified by the Practice and by
the CCG.

Identifying where Improvements were required

The Practice undertook two separate Investigations arising from JM’s case;
4. An investigation into what had happened to the letter from the Renal Administrative Team
at the Royal Salford Hospital to JM, when the Next of kin brought it to reception.
2, A Significant Event Analysts, which took place with input from the District Nursing Team on
25 February 2019.

One of the concerns raised by yourself was the potential for vulnerable patients to fall through the
gaps of care between providers. The Practice has recently been inspected by the CQC (report not
yet available) as part of that process the Practice has recently reviewed staff training In
Safeguarding and the Practice’s Safeguarding procedures and all staff members are up to date. We
therefore did not undertake a further Investigation Into staff training In safeguarding but
consideration of patient vulnerability was dealt with in the SEA and followed up during the clinical
meeting on 18 March 2019.

A copy of the SEA is enclosed with this letter and the table sets out the findings and actions
undertaken as a result of these investigations.

Steps taken by the Practice

The CCG have advised the Practice that if we are asked to accept responsibility for the monitoring of
patients prescribed EPO by secondary care again we should not accept that responsibility. Whilst
this reinforces that It was the right decision not to agree to undertake the ongoing monitoring that
the Renal Team had asked JM to arrange, the Practice were concerned that our systems for
escalating the concern within and outside the Practice were not as robust as they should have been.

The Practice has Identified areas where staff required training, staff needed to be reminded of
Practice Procedures or a Procedure needed to be put In place, This training and need is set out in
the table enclosed with this letter, in the green section.

Training has been delivered through Practice meetings. The Practice holds weekly non-clinical
meetings and fortnightly clinical meetings in addition to monthly Practice meetings for the whole of
the Team. This training has been reinforced with follow up emails to all staff, The Practice has also
scheduled reviews and audits to ensure that the changes have been effective and to Identify any
ongoing patterns of concern. Please see the enclosed table.

The Practice has updated the CCG with the findings from these Investigations and the findings have
been fed back to staff at the Practice. As mentioned above the CCG have requested that the Practice

Oldham

a S OL8 3HH

Tel: 0161 620 1611

Medical Practice stchads.medicalpractice@nhs.net

does not write to the Renal Team as they are going to correspond directly with the Trust regarding
the issues raised in thls case. We will continue to keep this matter under review and review our
processes again once we recelve further feedback from the CCG.

We hope that you find the information set out in the table attached useful and we would be happy

to discuss these issues in more detail, Your office is welcome to contact Dr Gill on
. wre to arrange a convenient time to discuss this matter further.

Yours sincerely,

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