Thomas Warren

From Dr Dan Poulter MP
Parliamentary Under Secretary of State for Health

Department
Richmond House
of Health 79 Whitehall
London
SWIA 2NS
Mr A Harris Tel: 020 7210 4850
Senior Coroner
The Coroner’s Court
1 Tennis Street
London
SE1l 1YD
16 OCT 20%4
Dear Mr Harris

Thank you for your letter following the inquest into the death of Thomas
Warren. I was very sorry to read of Thomas’ tragic and avoidable death.

I understand Thomas suffered from cerebral palsy. Your report indicates that on
17 November 2008, Thomas was prescribed a 25mg Fentanyl patch for pain by
a doctor in the A&E department of the Queen Elizabeth Hospital Woolwich.

He developed symptoms of drowsiness, sickness, drinking a lot and feeling hot
and cold. He had a heart attack at home on 19 November 2008 and although
advanced life support was provided by ambulance and hospital staff, he did not
regain consciousness and died later the same day.

You found that the failure of the prescribing doctor to admit Thomas to hospital
and prescribing an opiate drug to a small opiate-naive child, outside the drug’s
licence, amounted to neglect. Opportunities were missed by the pharmacy to
stop the dispensing of the drug and to give Thomas’s parents adequate
information to monitor the effects of the drug.

The prescribing doctor was recruited as a locum Paediatric Registrar the day
before this incident, through a recruitment agency. There appeared to be no
requirement by the Trust for the Agency to make checks on registration or
fitness to practice.

The Trust did not interview the doctor concerned but had checked there were no
restrictions on the doctor’s practice by the GMC. It had obtained a reference
from an employer in Canada. However, the doctor had been employed in New
Zealand in the interim where concerns were raised and an investigation begun.
In addition, the doctor had been referred for NCAS assessment from an NHS
Trust in Wales in 2007. This had not been completed because the doctor left

NHS employment and went to New Zealand in January 2008. The assessment
was subsequently completed in 2009.

At the evidence giving, a former Trust medical director agreed it would be
feasible for a consultant to ask each new locum about previous fitness to
practice concerns or NCAS referrals and that such an initiative would reduce the
risks. He also considered that revalidation would offer more reassurance in
future, although not necessarily for prospective employers of locums from
abroad or with long gaps between UK jobs, as was the case here.

Evidence also suggested that the problem was a complex national one so that
the issues should be considered nationally, not just by the local Trust. I agree
with this assessment. Robust recruitment and quality assurance of locum
doctors working in secondary care is an important issue, and there are several
strands of work aimed at improving the situation.

In December 2012, the General Medical Council (GMC) introduced the system
of medical revalidation. The vast majority of doctors practising in England will
have undergone revalidation during the next three years. All doctors licensed to
practise in the UK are now required to demonstrate every five years that they
are up-to-date and fit to practise. This is achieved through regular participation
in medical appraisal.

In support of medical revalidation, Responsible Officers (ROs) have a statutory
duty to ensure appraisal and clinical governance systems are robust and, once
every five years, to use outputs from appraisals and clinical governance
information to make a revalidation recommendation to the GMC for each
doctor. Thus information about doctors, including locums, should be available
at national level (held by the regulator) and at local level (held by the
employer).

Medical revalidation is still at a very early stage and we need to allow time for
the system to bed down so we can assess how well arrangements are working in
practice. In the meantime, we have asked the GMC to monitor issues relating to
secondary care locums and ensure these issues are reflected in their annual
reports.

In November 2013, I established a high level Secondary Care Locum Doctor
Working Group. This made a series of recommendations to Government to
strengthen the existing arrangements:

AG From Dr Dan Poulter MP
Parliamentary Under Secretary of State for Health

Department Richmond House
of Health 079 Whitehall
SWiA2NS

‘ . Tel: 020 7210 4850
e to strengthen GMC guidance to doctors on appraisals about the need to

report on any locum work undertaken;

e to strengthen guidance to ROs to ensure they check with doctors that
locum work has been recorded;

e to strengthen the NHS Employers Pre-Employment Standards to include
a seventh standard - covering the need for an employer to be provided
with information about an individual’s RO, dates of revalidation,
appraisal and that the employer should check an individual is both fit for
practice and purpose;

e NHS Employers to publish a standard audit guide for pre-employment
checks, providing greater confidence in audits and checks;

e to strengthen guidance for Trusts, emphasising the desirability of using
framework locum agencies, with a section to include best practice when
using non-framework agencies;

e NHS Employers to issue guidance to Trusts suggesting the development
of a set of core metrics on locum usage, which will give boards visibility
of locum usage and quality assurance processes; and

e to provide guidance to Trusts on best practice with regards to quality
assurance controls, which sets out minimum requirements.

It is the responsibility of both the locum agency and the healthcare provider to
check a doctor is up to date, fit to practise and suitable for a specific post.
Ultimately, the employer is responsible for the staff it employs, but if an agency
is involved, the agency should apply the same checks as the Trust itself would if
employing directly.

The current regulations, (The Health and Social Care Act 2008 (Regulated
Activities) Regulations 2010), state that the provider must operate effective
recruitment procedures to ensure that no person is employed to provide
healthcare unless that person is of good character, has the necessary
qualifications, skills and experience, and is physically and mentally fit for their
role.

Employers must also ensure that for each person they employ, they have
available satisfactory evidence of conduct in previous employment concerned
with health or social care, including children or vulnerable adults. Where a
person was previously employed in a position that involved work with children,

the provider must have satisfactory evidence, as far as is reasonably practical, of
the reason why that employment ended, and a full employment history, with
satisfactory written explanations of any gaps in employment.

These regulations apply to the employer and ultimately, if the Care Quality
Commission (CQC) judges that they have not been met, CQC can take
enforcement action.

In addition, the Medical Profession (Responsible Officers) Regulations 2010
make it a responsibility of ROs to ensure medical practitioners have
qualifications and experience appropriate to the work to be performed and to
ensure appropriate references are obtained and checked. ROs are fully
registered licensed doctors who are responsible for evaluating other doctors’
fitness to practise and ensuring effective systems are in place within
organisations for the medical revalidation of doctors.

NHS Employers subsequently published guidance on the appointment and
employment of locum doctors in 2012 and updated it in August 2013.

http://www.nhsemployers.org/~/media/Employers/Publications/Guidance-on-

the-appointment-and-employment-of-locum-doctors.pdf

Section six of this guidance, concerning ‘NHS Employment Check Standards’
states:

“NHS providers must give evidence of their compliance with these six standards
as part of the Care Quality Commission’s annual regulatory framework. When
employing or engaging locum doctors via an agency, organisations must
provide evidence to the Care Quality Commission that the agency is satisfying
the same level of employment check standard for each individual doctor as an
NHS organisation would apply. Ultimate responsibility for the competence of
locum doctors rests with the employer. If the employment checks are delegated
to an agency, there must be a clear understanding between the two parties so
that no checks are overlooked for any individual doctor.”

The Responsible Officer Regulations and GMC guidance make it clear there is
an obligation to share information about a doctor when required to maintain
patient safety. The NHS Revalidation Support Team developed the Medical
Practice Information Transfer (MPIT) form to support the appropriate transfer
of information about a doctor’s practice to and from the doctor’s RO.

ROP From Dr Dan Poulter MP
Parliamentary Under Secretary of State for Health

Department ——
ichmon liouse

of Health ° 79 Whitehall
London

SW1A 2NS

Tel: 020 7210 4850
The RO system should now ensure that there is a record of any locum work
doctors have done, including any concerns about performance, thus enabling a
better transfer of information between NHS organisations.

In addition, an alert notice system also exists whereby an NHS employer can
make other bodies aware that a healthcare professional may pose a threat to
patients or staff. This system is now administered by the National Clinical
Assessment Service (NCAS), having previously been managed by Strategic
Health Authorities. NHS organisations who wish to request the issue of an Alert
Notice must notify NCAS. NCAS has developed an Operational protocol for
issue of Health Professional Alert Notices which can be seen at the following
link:

http://www.ncas.nhs.uk/EasySiteWeb/GatewayLink.aspx?alld=133014

The ROs, introduced to support medical revalidation, should also ensure
appropriate clinical governance systems are in place to record information about
the performance of doctors within their organisation. For short-term locum
appointments, it is particularly important to ensure any concerns about a doctor
are passed on. An exit report should be completed and sent to the doctor, the
locum agency and the Responsible Officer, if the Responsible Officer is not
from the agency that supplied the doctor. This will help ensure appropriate
remediation is put in place. Where there are serious, immediate, concerns about
public safety, the alert notice system would enable an NHS employer to make
other bodies aware that a healthcare professional may pose a threat to patients
or staff.

Your main concerns in this case rightly focus on the employment of locum
doctors and the systems that exist to ensure fitness to practise. However there is
an issue concerning the prescribing of an opiate drug, fentanyl, to a small opiate
naive child. I have therefore provided the following supplementary information
on the use of fentanyl, which you may find of interest.

Officials at NHS England have advised that the risks associated with the unsafe
use of fentanyl patches are known by the Medication Safety Team in NHS
England. In response to a number of patient safety incident reports concerning
fentanyl transdermal patches, the team, working with the CQC, have published

guidance on the risks with fentanyl patches, and additional system safeguards to
minimise the overdose of fentanyl patches to opiate naive patients. This

guidance has been distributed to the Accountable Officers for Controlled Drugs
in the NHS and is published on the CQC website at the following address:

http://www.cqc.org.uk/content/use-controlled-drugs

This guidance recommends that healthcare provider organisations consider the
following safeguards:
Checklist for safer use of fentanyl and buprenorphine CD transdermal

patches
1, CD transdermal fentanyl patches should be restricted to patients that are

already receiving regular doses of opioids

i. Do not use for acute pain.
ii, Do not use in opiate naive patients.

2. Before using a CD transdermal patch, calculate the total daily dose of all the
opioid analgesics that the patient has received previously. This is usually in
morphine equivalence.

Use locally or nationally approved dose conversion charts to do this. There are
dose conversion charts in the ‘Prescribing In Palliative Care’ Section of the
British National Formulary and in CD transdermal manufacturers guidance
(SPO).

3. Determine a new dose of analgesia to be delivered by transdermal CD patch
in morphine equivalents. For changes in analgesia, as a ‘rule of thumb’, the
total daily dose should not be increased in steps greater than 50% of the
previous daily dose.

Use a conversion chart to determine the total daily dose of analgesia by CD
transdermal patch(es) and where necessary divide by 24 to equate with the
micrograms/hour strength of available products.

To deliver the intended dose more than one CD patch may have to be used.
n/b - Formally double check the calculations and where possible have the
patient’s dose independently verified.

AGS From Dr Dan Poulter MP
Parliamentary Under Secretary of State for Health

Department —
of Health ceo Whitehall
London

SWIA 2NS

; , Tel: 020 7210 4850
Following your letter, the Medication Safety Team at NHS England is planning,
once again, to highlight this risk and the recommended safer practice at a future
monthly meeting of the National Medication Safety Network.

I hope that this response is helpful and I am grateful to you for bringing the sad
circumstances of Thomas Warren’s death to my attention.

Yours sincerely,

Dr Daniel Poulter MP

Lewisham and Greenwich NHS)

NHS Trust

University Hospital Lewisham

Lewlshara High Street
Tim Higginson London
Chief Executive SE13 6LH

Tel: P| Tel: 020 8333 3000
Fax: Fax: 020 8333 3333

es Web: www.lewishamandgreenwich.nhs.uk

10" October 2014

Dr Andrew Harris
Assistant Deputy Coroner
London South Inner

The Coroners Court

1 Tennis Street
Southwark

SE1 1YD

Dear Dr Harris
REGULATION 28 REPORT TO PREVENT FUTURE DEATHS
Re Master Thomas Warren

| am writing in response to your report dated 19" August 2014 and referenced above. The report
raised four matters of concerns and my understanding is that the only the first matter raised is for
the Trust to address,

The matter raised {s that:

There does not appear to be clarity as to who or which organisation should enquire into previous
fitness to practice concerns and referrals to NCAS which have not led to restrictions or conditions of
registration by the GMC when locum doctors are being recruited by an Agency af short notice by
prospective NHS Trusts, In this case it appears that neither that Recruitment Agency nor Trust nor
consultant asked the doctor before his employment began.

NHS providers are required to provide evidence of compliance with the NHS Employment Check
Standards as part of the CQC's annual regulatory framework. The CQC’s Essential Standards of
Quality and Safety outline 16 core standards which must be met, including having robust
recruitment practices in place (Outcome 12 Requirements relating to workers, specifically refers).
The Employment Check Standards are also embedded In the Crown Commercial Service (formerly
known as the Government Procurement Service) National Agency Framework Agreement and
annual audit checks of agencies, to assure compliance with the standards Is met in relation to
contracted and sub-contracted staff.

All staff recruitment at the Trust Including engagement of agency medical staff Is completed in fine
with these requirements. The six checks required are:

1. Identity checks

2, Right to work checks

3. Professional registration and qualification checks

4, Employment history and reference checks

One Trust - serving our local communities

5. Criminal record and barring checks
6. Occupational health checks

As part of the professional registration and qualification check, the Trust verifies on line with the
Registered Body , in this case the GMC, whether the candidate:

e is registered to carry out the proposed role

e is subject to any current restrictions

e has investigations against them about their fitness to practise.

As confirmed in your report, the Trust completed these checks with the GMC and did not find any
conditions, restrictions, or information about investigations into fitness to practice. The doctor
himself was not asked about any previous fitness to practice concerns by the Trust, or the
recruitment agency concerned, but there is no specific requirement to do so and given that no
concerns had arisen through other aspects of the checking processes, there would be no apparent
reason to enquire further.

In addition, we have considered the recommendations to undertake action to consider changes to

recruitment policy or practice. Our arrangements for revalidation support this. Under the

requirements of revalidation, the Trust as a designated body, has to review its system and

processes against core standards, return a compliance statement to the NHS England Responsible

Officer and present an annual report to the Trust Board. This requirement includes the need to:

¢ Ensure that appropriate pre-employment background checks (including pre-engagement for
Locums) are carried out to ensure that medical practitioners have qualifications and experience
appropriate to the work performed

This process provides a very useful summary at Board level of any gaps in processes and will
develop further as medical revalidation becomes embedded over time.

We also review both policy and practice in relation to employment checks on a regular basis and as
changes to the national requirements are introduced. Our Internal audit team will be reviewing the
processes for temporary staff, Including medical agency staff, In January 2015, and any
recommendations from this audit will of course will implemented.

Finally, the Trust only uses medical agency staff supplied by agencies that are approved under the
National Agency Framework Agreement, and uses one main agency provider for the vast majority
of bookings. This provides additional assurance in relations to checking processes,

| wish to assure you that my team and | take these concerns very seriously and remain open to any
suggestions about how we could further improve current checking processes. The changes to the
health care professional reporting requirements made in 2013, which have become the
responsibility of NCAS, may help to improve the accessibility of information about such concerns
about an individual in the future,

Should you have any questions in regard to any of the information in this letter or require any
further information please do not hesitate to contact me.

Yours sincerely

Tim Higginson
Chlef Executive

One Trust serving our focal communities