Gladys Sayles

HER MAJESTY’S CORONER
For the West Yorkshire (Western) Coroner Area

The Chief Coroner,

Rule 43 Reports,

Chief Coroner’s Office, Our ref: MDF-HK/2471-2018
11" Floor, Thomas More Building,

Royal Courts of Justice, 27th September 2019

Strand,

LONDON. WC2A 2LL

Dear Sir,

Re: Gladys May Sayles, deceased
Report to Prevent Further Deaths
Paragraph 7, Schedule 5 of the Coroners and Justice Act 2009 and
Regulations 28 and 29 of the Coroners (Investigations) Regulations 2013

Please find enclosed a copy of a response report received from The Leeds Teaching Hospitals NHS
Trust.

Yours faithfully,
M.D. Fleming

Senior Coroner
West Yorkshire - Western

Enc.

City Courts The Tyrls Bradford BD] 1LA
Telephone: 01274 391362

Ref: Enquiry into the death of Gladys May Sayles The Leeds

DOB: 05/08/1928 NHS No: 4748684933 Teaching Hospitals
Date: 5 September 2019 NHS Trust

Private & Confidential Trust Headquarters
Mr M D Fleming, Leeds Teaching Hospitals Trust
Senior Coroner St James's University Hospital
West Yorkshire (Western) Coroner Area Becket birest
City Courts LS9 7TF

The Tyrls

e www.leedsth.nhs.uk
Bradford BD1 1LA f

he

f

i

In the matter of an enquiry into the deathof-Gladys May Saylés:RE: regulation
28 report

Dear Mr Fleming,

Thank you very much for your letter dated 3 September 2019. In your letter you
indicated that you were invited by representatives from Calderdale and Huddersfield
NHS Foundation Trust and the family to ask that Leeds Teaching Hospitals NHS
Trust be incorporated into the Regulation 28 report. This is in respect of the
effectiveness of the existing communications between Leeds General Infirmary
Neurosurgical Unit and Huddersfield Royal Infirmary. The Regulation 28 report also
refers to the fitting of collar and the patient’s general care. In your letter you invite us
to reconsider the current systems of communication between ourselves and referring
hospitals such as Huddersfield Royal Infirmary.

I have now had the opportunity to review the communications between the referring
team and the on call Neurosurgical Team. | note from the detailed records that the
first contact was made a at Huddersfield at 14:54 hours on 21
September 2018. A response was sent at 17.42 on the same day by MEE with
advice that the cervical spine CT showed significant rotation and displacement of a
fractured ‘bone fragment. [J inquired about the patient's neurology and
agreed to discuss this with the on call consultant. At 20.47 J again
contacted Huddersfield Royal Infirmary confirming that the images had now being
reviewed by the on.call consultant and the operative care was not indicated.. The
treating team Huddersfield Royal Infirmary were advised to manage the injury with a
neck brace.

Without further promptingi contacted the clinical team at Huddersfield
again on the following morning at 09.48. This was following a further review of the
case and imaging at the morning handover meeting. The advice remained the same
that conservative and supportive care was indicated and that the patient could be
managed locally in Huddersfield. Further contact was made on the 2 October 2018
at 11:54 when the referring team sought an update on the management plan.
Unfortunately the images were not sent electronically and the team at Leeds
responded at 13:17, including a request for the scans. The images were sent across

Chair Dr Linda Pollard ceeo. Chief Executive Julian Hartley

The Leeds Teaching Hospitals incorporating:

Chapel Allerton Hospital Leeds Dental Institute Seacroft Hospital .

St James's University Hospital The General Infirmary at Leeds Wharfedale Hospital

at 11:35 on the following day 3 October 2018. This was at 11:35 and there followed
further communication between the two teams at 12:34, 15:53 and 17:36 the same
day. It remained clear that Mrs Sayles was not a suitable candidate for operative
intervention and that continued best supportive care at Huddersfield would be
sensible in the circumstances. | was saddened to hear that Mrs Sayles had not
recovered and subsequently died.

Having reviewed the communications between the referring team and the Leeds
Neurosurgical Unit, | have come to the conclusion that the discussions were had in a
timely fashion and that the appropriate advice was given. It is recognised that an
electronic system such as this can be somewhat frustrating for the referring team but
it does allow for robust data capture and to ensure a proper audit trail. | am satisfied
that the current arrangements are appropriate and responsive.

| hope you have found this reassuring but | would be more than happy to provide any
further details if you felt that was necessary.

Yours sincerely

A Da

— a Director (Risk Management)

Chair Dr Linda Pollard ceeo. Chief Executive Julian Hartley

The Leeds Teaching Hospitals incorporating:

Chapel Allerton Hospital Leeds Dental Institute Seacroft Hospital

St James's University Hospital The General Infirmary at Leeds Wharfedale Hospital

RESPONSE TO REGULATION 28 CORONER’S REPORT TO PREVENT FUTURE
DEATHS

1 ~] THIS RESPONSE IS MADE ON BEHALF OF
Calderdale and Huddersfield NHS Foundation Trust

2 THIS REPORT IS BEING SENT TO:
Calderdale and Huddersfield NHS Foundation Trust
Leeds Teaching Hospitals NHS Trust
Taycare Medical Limited, Unit 2, Royds Close, Leeds

3 CORONER ;
Martin Fleming HM Senior Coroner for West Yorkshire Western |

4 CORONER’S LEGAL POWERS

| make this report under paragraph 7, Schedule 5, of the Coroners and Justice
Act 2009 and regulation 28 and 20 of the Coroners (Investigations)
Regulations 2013

5 INVESTIGATION AND INQUEST

On 15 October 2018 | opened an inquest into the death of Gladys May Sayles
who, at the date of her death was aged 90 years old. The inquest was
resumed and concluded on 9 July 2019.

| found that the cause of death to be: -
1a — Fracture of C2 and C3 vertebrae

| arrived at a conclusion of Accident

6 CIRCUMSTANCES OF DEATH

At approximately 6:10pm on 26 August 2018, Gladys May Sayles was found
collapsed with a head and neck injury after an unwitnessed fall in the kitchen
of her home address TT yo: Yorkshire.
Upon the arrival of the paramedics she was taken to Huddersfield Royal

Infirmary, where a CT scan revealed that she had sustained fractures to her
C2 and C3 vertebra.

Although she was subsequently managed conservatively with a hard collar,
she deteriorated such that she was discharged for palliative treatment on 3
October 2018 to Overgate Hospice, where she succumbed and died on 8
October 2018.

Although | found that the hard collar did not play any part in the sad death
communication and training issues with respect to the use of the hard collar
were identified.

7 CORONER’S CONCERNS

| The MATTER OF CONCERN is as follows: -
‘To review the existing guideline with respect to use of Aspen collars.

e To review training with respect to the application and fixing of the collar
in order to make it bespoke to patient's needs.

e To consider the effectiveness of existing communications between
Leeds General neurological unit, Huddersfield Royal Infirmary and the
suppliers of collar’s with respect to the fitting of the collar and patients
general care.

RESPONSE TO REGULATION 28 CORONER’S REPORT TO PREVENT FUTURE
DEATHS

8 ACTION SHOULD BE TAKEN

In my opinion action should be taken to prevent future deaths and | believe
that Calderdale and Huddersfield NHS Foundation Trust, Leeds Teachings
Hospital NHS Trust and Taycare Medical Ltd, has the power to take such
action. In circumstances it is my statutory duty to report to you.

9 RESPONSE

PREAMBLE TO RESPONSE:

Evidence was heard at the inquest confirming that Leeds Teaching Hospitals
Trust (LTHT) are the Trust responsible for the diagnosis, treatment and care
plan for patients who have suffered a spinal injury. Taycare Medical Ltd (TML)
are the healthcare organisation responsible for providing orthotic care to
patients with a spinal injury. Calderdale & Huddersfield NHS Foundation Trust
(CHFT) are responsible for managing the general care of patient with a spinal
injury, whilst they are admitted to the trust.

CONCERN 1 — GUIDANCE RELATING TO USE OF ASPEN COLLAR:
The use of-an Aspen collar for treatment in a patient with a spinal injury is a
decision that is made by LTHT.

As CHFT do not make decisions on the use of an Aspen Collar for patients
with spinal injuries we would not be in a position to fully address this concern.
When a patient who requires a hard collar is nursed on a ward within the Trust,
written guidance on the application of that collar and care and treatment are
provided by TML.

CONCERN 2 — TRAINING IN THE USE OF ASPEN COLLARS:

Although CHFT staff do not fit the Aspen Collar, this is undertaken by TML,
CHFT staff are responsible for the general care of a patient, who requires an
Aspen Collar; this will involve removing the collar and reapplying it.

CHFT does not offer any formal training for application of Aspen Collars;
however, bespoke training is provided by TML when a patient, who requires an
Aspen Collar, is being cared for under CHFT. TML will also leave written
instructions with the patient in relation to the application of the Aspen Collar,
which CHFT staff will follow.

On further discussion with staff who were caring for Mrs Sayles, CHFT can
confirm that they were competent and confident in the use of Aspen Collars.
Due to the low number of patients CHFT sees requiring an Aspen Collar, it is
felt that bespoke training is the safest model of training delivery. Bespoke
training when required ensures staff caring for a patient with an Aspen Collar
understand how to remove and apply the Aspen Collar and can follow the
written instructions left with the patient.

CONCERN 3 — COMMUNICATION BETWEEN CHET, LTHT AND TML:
When an Aspen Collar is required a referral is sent to TML to fit the collar.
Should problems arise with the Aspen Collar when the patient admitted onto a
ward at CHFT, CHFT staff will contact TML, via to telephone, regarding the
problem encountered. Following this contact TML will attend the ward to
reassess the patient.

Should problems persistent CHFT staff will contact LTHT for further advice on
the treatment and management for a patient with an Aspen Collar, explaining

RESPONSE TO REGULATION 28 CORONER’S REPORT TO PREVENT FUTURE

DEATHS

the difficulties encountered.. CHFT will follow the advice given by LTHT.

In relation to Mrs Sayles’ case, the orthotists at TML were contacted on seven
occasions between 26 August 2018 (admission) to 5 September 2018
(discharge),

when difficulties arose regarding Mrs Sayles’ hard collar. On each occasion
an orthotist attended the ward to assess Mrs Sayles on the same day they
were contacted. LTHT were contacted on 21 September 2018 regarding the
continuing concerns relating to the Aspen Collar and LTHT advised CHFT to
remove the collar on 22 September 2018.

CHFT have considered the effectiveness of communication between CHFT,
LTHT and TML. From the Trust perspective communication has been timely,
there have been no delays from calling TML to them being on site to offer
recommendations and advice, and communication with LTHT has been clear,
concise and informative. Lo:

THIS RESPONSE HAS BEEN PREPARED BY
, Head of Legal Services and Compiaints
MR Orthopaedic Consultant
enor Ward Sister, Trauma and Orthopaedics

DATE OF RESPONSE
24 September 2019

Units 1-2
Royds Close

= Leeds
LS12 6LL
l a re T: 0113 231 1800

F: 0113 231 1805
reception@TayCare.com
www.TayCare.com

®

Suppliers of Orthotic Products and Services

Our ref: PNT/LET
Your ref: MDF-HK/-2471-2018
19 September 2019

ee ne NETTIE NTE PLO NES

Mr Martin Hleming | ana ’
Senior Coroner # RECEIVED) :
They ~ | 49 Sep 2019

The Tyris

Bradford

BD1 1LA =

Dear Mr Fleming

Re: Gladys May Sayles, deceased
Report to Prevent Future Deaths
Paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and
regulation 28 and 20 of the Coroners (Investigations) Regulations 2013

I write further to your letter dated 26 July 2019 and Regulation 28 Report.

As you will be aware TayCare Medical Ltd was contracted by Calderdale and Huddersfield
NHS Foundation Trust to supply and fit an Aspen Collar for Gladys May Sayles whilst she
was in their care.

Whilst you have found that the hard collar did not play any part in the sad death you have
indicated that communication and training issues with respect to the use of the hard collar
were identified such that TayCare Medica! Ltd has the power to take action to prevent future
deaths.

As we were not present at the inquest, we do not have knowledge of what led to the
Matters of Concern, but we respond to them as follows.

1. To review the existing guideline with respect to use of Aspen collars.

TayCare Medical Ltd follows rather than creates guideline with respect to use of Aspen
collars.

In an NHS setting the decision to use an Aspen collar is taken by treating doctors. Whether
that decision is based on a set of clinical guidelines is outside of TayCare’s knowledge.

TayCare’s role, upon receipt of a referral, is to supply and fit the collar once the decision to
use it has been made,

Company Registration No. 204227
Managing Director: P. Taylor © am,

Director: B. Taylor Rt rrstncssanonnos coven

a
Care

Guidelines in terms of the fitting of the collar are provided by the manufacturer. I enclose
instruction sheets for the Aspen Collar and Aspen Vista Collar. These are the guidelines we
follow.

2. To review training with respect to the application and fixing of the collar in order
to make it bespoke to patient’s needs.

Aspen collars are an off the shelf product. There is no bespoke element to their construction
and TayCare is not involved with their construction.

Following the manufacturer's instructions results in the appropriate fit for each patient. You
will see from the instructions enclosed that appropriate fit is achieved by following, in
particular, the sections on ‘sizing’, ‘Position Front’, ‘Adjustments’ and ‘Proper Fit’ (for the
Aspen Collar) and ‘sizing’, ‘tightening’ and ‘tips’ (for the Aspen Vista).

To be an orthotist you need a recognised qualification from a national body called, The
British Association of Prosthetists and Orthotists (BAPO). To gain this qualification you have
to complete and pass a 3 year specialist course run by one of two universities - Salford and
Strathclyde. During the course of that qualification the orthotist learns how fit hard collars.
The BAPO website (www.bapo.com) gives further details, and confirms that:

"Orthotists are autonomous registered practitioners who provide gait analysis and
engineering solutions to patients with problems of the neuro, muscular and skeletal
systems. They are extensively trained at undergraduate level in mechanics, bio-
mechanics, and material science along with anatomy, physiology and
pathophysiology. Their qualifications make them competent to design and provide
orthoses that modify the structural or functional characteristics of the patients’
neuro-muscular and skeletal systems enabling patients to mobilise, eliminate gait
deviations, reduce falls, reduce pain, prevent and facilitate healing of ulcers. They
are also qualified to modify CE marked Orthoses or componentry taking responsibility
for the impact of any changes. They treat patients with a wide range of conditions
including Diabetes, Arthritis, Cerebral Palsy, Stroke, Spina Bifida,Scoliosis, MSK,
sports injuries and trauma. Whilst they often work as autonomous practitioners they
increasingly often form part of muttidisciplinary teams such as within the diabetic
foot team or neuro-rehabilitation team.”

All of our orthotists are appropriately qualified and trained in this way. Furthermore, all of
our new staff have a probationary period during which they have a mentor to ensure that
they are operating correctly. During this probationary/training period we undertake mock
fittings to assess their competence.

As orthotists, we are regulated by the health care and professions council (www.hcpc-
uk.org) and to maintain the required registration must meet their Continuing Professional
Development requirements.

I am therefore satisfied that all TayCare orthotists are appropriately trained with respect to
the application and fixing of the collar in order to make it bespoke to patient’s needs.

Company Registration No. 204227
Managing Director: P. Taylor
Director: B. Taylor

aN
Care

If it should ever be required, those engaged in fitting a collar will always have the
manufacturers clear instructions with them. Every collar we supply is new and comes
supplied with a copy of the applicable instructions. Those instructions are then left with the
patient after fitting.

TayCare has no power to order, arrange or give training to NHS Staff.

3. To consider the effectiveness of existing communications between Leeds General
neurological unit, Huddersfield Royal Infirmary and the suppliers of collar’s with
respect to the fitting of the collar and patients general care.

The initial communication TayCare Medical Ltd would receive would be the referral from the
NHS Trust for the fitting of an Aspen Collar. This would contain the diagnosis of the patient
and the request for the hard collar. Upon receipt of the referral an orthotist would attend
the patient; this is usually the same day.

When the orthotist presents to the ward where the patient is situated, they would report to
the sister in charge, and explain the reason for their visit. A nursing member of staff would
accompany the orthotist to the patient.

The orthotist wilt explain in detail to the patient what the assessment and fitting involves. In
a patient who does not have capacity, this would be explained to the patient’s next kin, and
in the absence of next of kin and capacity the collar will be fitted in the patient’s best
interest.

Once the orthotist is satisfied that the collar has been fitted correctly, a discussion takes
place with the patient to once again to explain what has happened and the written
instructions for the collar are left with the patient.

Appropriate notes are added directly and electronically to the Calderdale and Huddersfield
NHS Foundation Trust's clinical record by the orthotist.

The collar purchased by the NHS is then NHS property and the patient remains under the
care of the NHS. TayCare has no power to monitor the ongoing use, removal, refitting and
adjustment of the collar thereafter.

Company Registration No. 204227
Managing Director: P. Taylor
Director: B. Taylor

oN
Care

However, we always leave our involvement as ‘open review’ because we are always happy
to return to assist with any issues or concerns that arise. On occasions some patients may
find that a further review is required. It may be that the collar requires replacement liners or
the collar requires re-adjustment after removal and refitting by the care provider for
washing/hygiene reasons. In these circumstances we may receive a referral from the
hospital for a review and we are always happy to attend promptly to address any concerns.

I am satisfied that TayCare Medical Ltd already operate suitably and safely but if I have
misunderstood the intent of your report then I would be happy to discuss the issues with
you in more detail.

Yours sincerely

TayCare Medical Ltd

Company Registration No. 204227
Managing Director: P. Taylor
Director: B. Taylor