Gary Bradshaw

Stockport INHS|

NHS Foundation Trust

M{ustted hon anne Hall House

Stepping Hill Hospital

Sk2 7J

Our ref. AB/RF/CM/PR-letter to HM Coroner GBradshaw
Your ref. JK//KA/1574-2012

Coroner's Court
Mount Tabor
Mottram Street

Telephone: 0161 483 1010
Fae

Stockport

SK1 3PA :

8" July 2014 Bh

Dear Mr Pollard oot Di

Re: Gary Bradshaw 15/ 03/1965 (Deceased)

Thank you for your letter, of the 15" May 2014 , concerning the inquest of the above named. As always, I
am grateful to you for highlighting your concerns on the Regulation 28 ‘Report to prevent future deaths’

and for providing me with an opportunity to respond.
I shall address each of your concerns in the order in which you raised them:

1. There was a considerable delay in the initial diagnosis that he was suffering with kidney

stones, between May 2011 and March 2012.
The report of the Ultrasound Scan, undertaken on 15" July 2011, stated that there were:

“several echogenic foci in the lower pole of the right kidney. Two of these exhibit shadowing and
are likely to represent renal stones. The right kidney is otherwise normal, There is no

hydronephrosis. There is no scarring.”

As these stones were not causing any obstruction they were deemed to be ‘incidental findings’ and
were not responsible for his groin pain. It was felt important to follow up the stones but by leaving a
period of time between the Ultrasound Scan and follow up, this would assist in determining whether
there was any significant change in the size of the stones which would influence their management.

In order to try and prevent further problems, such as Mr Bradshaw experienced, there is a policy in
place to undertake a calcium and urate blood test as soon as possible following a new diagnosis of
kidney stones. If it has been discovered, whilst the patient is in hospital, that they have stones and
their calcium and urate levels are normal-and the plan has been explained to the patient already, then
they will be seen in the outpatients’ department at 6 months; however, if it was an incidental finding

and the patient does not know th

problems, check their bloods and explain the follow up.

At the consultation in March 2012 both blood and urine tests were ordered but apparently
only the urine tests were done and/or reported, thus his hypercalciuria was seen but not

his hypercaiceamia
At Mr Bradshaw’s clinic attendance‘on 19th March 2012, requested staff to take blood for
serum urate and calcium levels; for an unknown reason {he serum calcium was not requested at the

time the electronic order was made and so after it was printed, a member of staff added ‘+CA’ (plus
calcium) in handwritten format next to ‘clinical information’ on the printed request form. Investigation
of the case subsequently determined that, when the request form was received in the laboratory, the

our Health. Our Priority.

staff there mistook the handwritten addition to mean ‘plus cancer’ (as it was written next to the clinical
information and not in the request column) and so the serum calcium was not determined.

There are some tests that have not been set up on the electronic ordering system due to there being
such a high number of possible tests available. We have the frequently requested tests on the system
and also some infrequently requested ones and continue to add on a regular basis. Technology
advances also increase the variety of tests becoming available; therefore it has been accepted practice
that such tests can be added to electronic requests in handwritten format. However calcium and urate

tests are on the system in their own right and as profiles.

All staff have been reminded that, where the parameter exists for a blood test to be ordered
electronically, it must be ordered in that way. Only in exceptional circumstances should a blood test
request, from within the Trust, be hand written. Exceptional circumstances are those such as an
emergency, when electronic ordering is not readily available, or when the blood test to be requested is
not available to choose in electronic format. If a blood test must be requested in hand written form,
then the test required should be written out in full and not abbreviated. All requests must be made in

the requests box within the form and not in the clinical details section.

patient was prescribed and administered

The above blood tests were ordered but the
(own, something which the expert witness

Bendroflumathiazide before the results were kn

described as contraindicated
accepted at inquest that he should not have prescribed Bendrofluamathiazide without

knowing the serum calcium results and will not do so in the future. He had expected to review the
results within a week and review his decision but unfortunately that did not happen as he expected.

We now have systems in place to allow | electronically check all tests done in his name in

the outpatients department.
There was a misunderstanding or misreporting of the results to the GP as to whether the

results related to blood or urine tests
On 14th June 2012 the pre-operative assessment nurse reviewed the bloods that had been ordered by

on 8th June 2012; however she only reviewed those bloods that fell within her remit at that
time. These included Mr Bradshaw's Complete Blood Count, Liver Profile and Urea and Electrolytes; the
nurse then wrote to Mr Bradshaw's GP that same day, enclosing copies of the results, advising him that
Mr Bradshaw had a low platelet count and that some of his liver functions were also deranged.
Although the nurse did not specifically mention the results pertaining to serum calcium in her letter,
these results, titled ‘total serum calcium 3.25 - range 2.20 — 2.60’ were at the very top of the report
that the nurse enclosed with her letter to the GP; it was clear that these results related to blood and

not urine tests.

Action
All consultants have been given clear instruction that it is their responsibility to ensure that they follow

up, or ensure that they have systems in place to follow up, any blood tests or any other investigation
that they order.

Mr Bradshaw was discharged from the hospital on the 27" June rather than being retained
as an inpatient whilst full investigations were carried out; again a practice which the
expert witness felt to be inappropriate.

Mr Bradshaw presented to the ED with renal colic and worsening of his kidney function; therefore the
plan for that emergency admission was to control his pain and rule out urinary tract obstruction
secondary to the known kidney stones as a cause of worsening of his kidney function. Mr Bradshaw
-had an urgent US scan of the urinary tract on the 26/6 and this showed the previously known kidney
stones with no evidence of hydronephrosis. The renal colic was controlled and Mr Bradshaw became
symptomatically better; a management plan for the kidney stones had been made. The serum
creatinine level was slightly elevated but he was known to be diabetic and the US scan did not show
any evidence of obstruction to his kidneys. Mr Bradshaw's blood sugar was elevated on admission;

2

however he was a known diabetic on regular medications and his blood sugar continued to drop

» Fluid balance charts were not kept,

» The hospital laboratory only “flag up”

spontaneously and it was at its lowest level on the day of his discharge.

Mr Bradshaw’s fitness for discharge was assessed by the fact that his pain was controlled, he was not
septic, there was no evidence of urinary tract obstruction necessitating urgent intervention and he had
a management plan in place for his kidney stones; however it has been accepted that this was a

missed opportunity for further diagnosis and treatment.
During the subsequent admission on the 29" June no consideration was given to referring

Mr Bradshaw to an endocrine surgeon,
has reviewed this question and states that all of his actions in the care of Mr Bradshaw were to

prepare him_for Surgery. Our Endocrine/ Parathyroid Surgeon is at Manchester Royal

Hospital. had not discussed urgent surgery with jas he was well aware that Mr
Bradshaw would not be able to have a general anaesthetic until a myocardial infarction had been

definitively excluded (we were awaiting an echocardiogram). had considered Possible treatment
with Cinacalcet which was also mentioned by the external expert, but he had dismissed this option due

to previous experience with a
precipitated by this medication.

t guidance has been changed to indicate that with acute severe

However in light of this case the trus
referral pathway should be completed within 72 hours.

hypercalcaemia, the investigation and
or kept properly on various occasions during the in-

patient stays.
A conversation has been held with the ward manager of A11 with regard to the poor documentation on
the fluid balance charts. The ward manager has reiterated with her staff the importance of
portance of documenting each event as it happens, i.e.

pleted / consumed a drink, IV fluids are completed or changed or a patient
has passed urine.

pliance, fluid balance charts are now reviewed by the staff on a two
rounding event (Intentional rounding is where a nurse will visit every
reach, they have all they need in

front and in reach of them and asks them if there is anything else they require)

To monitor this and ensure com
hourly basis at each intentional

The fluid balance charts are now also checked again just prior to handover from one shift to the next to

ensure they are up to date for the next shift / team of staff.

blood results if the blood calcium levels exceed
3.5mmol/L or more of serum calcium. The expert witness opined that this should occur at
levels of 3.0mmol/L and that this should be a national standard
The escalation of serum calcium levels above 3mmol/L was introduced into Trust processes in March
2014.
The system of escalation of patients from the wards to the ITU did not seem to be in place
or alternatively did not seem to have worked as it should have done when the ward sister

wanted to send the patient to the ITU.
There is a clear process for the escalation of patients from wa
transfer. If a member of staff is concerned regarding a patien

rds who require Intensive Care input /
‘s condition and believes that Intensive

call Intensive Care team who will discuss and review the patien
required. During our investigations we were unable to find an

this process.

This issue has been discussed with the Ward Sister, who has confirmed that she is aware of the policy

and how to escalate concerns for a patient; she is aware of her error and appropriate action has been
3

in her statement said that: :

'T checked his discharge summary and requested his old hospital notes as I could find nothing on
Aavantis under his case note number of F****z¢ that point.”

The Advantis system has been checked to try to replicate Me. if the search is his F number
Mr Bradshaw's details appear as well as all his records under both the F number and the J number

which is his actual patient number. If the search is for the J number then both the J number records
and the F number records are shown.

Patients appear over the years to have been given two hospital numbers (this is
a historical issue dating back to pre-electronic recording of notes) and the Trust works hard to ensure
that these, when recognised, are linked clearly. The safest way of searching for a Patient via the
system and the way advocated by the Department of Health is however to use the patient’s NHS
Number; if the system is searched using Mr Bradshaw's NHS number (which is on the front of his ED
records) then both the F number files and the J number files are shown.

It is known that some

11.I was told that a new electronic system of note keeping is being introduced at Stockport
and throughout the NHS, I would consider it helpful if the system had a built in flag which
highlighted to a doctor that he or she was Prescribing drugs before the requested
blood/urine test results had been received.

Electronic records have moved on considerably since 2011 for example we now have Advantis ED (The
Emergency Department electronic record), EPMA (Electronic pre
administration) and Advantis Ward (ward electronic records in its pilot stage). It is however not possible
at present to create a flag or a rule for the circumstance as described i.e. across disciplines
(Laboratory/Medication Administration). It is unlikely to be possible in the vast Majority, if not all Trusts

generates an urgent alert to Doctors and other clinicians of unwell and deteriorating patients, This
system has been piloted and evaluated on one ward in the Trust and is due to be rolled out across the

Trust. Phase one of the rollout, which will focus on the input of vital signs only, has commenced and is
being introduced on a ward by ward basis, with the alert functionality activated in phase two, planned

to commence in January 2015,

pe that this response answers your concerns and Provides you with the assurance that the Trust is
mitted to improving the quality of care we give to all our patients.

lease do not hesitate to contact me if you have any further questions regarding this matter,

Yours sincergly

Chief, Executive

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

Department neon
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of Health 79 Whitehall
POCS 863056 swine one
Mr J Pollard Tel: 020 7210 4850
Senior Coroner
Coroner’s Court
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1 Mount Tabor Street 10 JUL 20
Stockport
SK1 3AG

Thank you for your letter following the inquest into the death of Gary Bradshaw. In your
report you conclude that the medical cause of death was myocardial infarction, dystrophic
myocardial calcification and hypercalcaemia due to a tumour of the parathyroid gland and
bronchopneumonia.

I understand that in May 2011 Mr Bradshaw attended Stepping Hill Hospital in Stockport
reporting to the Accident and Emergency Department that he was suffering from right sided
groin pain. By July 2011 an ultrasound scan had revealed that he was suffering from kidney
stones. In April 2012 it was noted that he had high levels of calcium in his urine and in June
2012 he was reviewed by a urological surgeon who ordered serum calcium investigations to

be carried out. This surgeon also prescribed and administered bendroflumethiazide for Mr
Bradshaw before the results of the blood test were known.

At the end of June Mr Bradshaw again presented to the Emergency Department and this time
he collapsed in the waiting area. On 2" July it was assessed that he was suffering from
hyperparathyroidism. He then remained in hospital until his death on the 12" July.

You found that during the time before Mr Bradshaw’s admission to hospital and during his
last hospital admission, a number of opportunities were missed, some of which might have
alleviated his level of suffering and others which might have extended his life expectancy.

You raise a total of twelve concerns of which the following four (numbers 3, 8, 11 and 12 in
your letter) are for our attention and that of Stockport NHS Trust:

e blood tests were ordered but the patient was prescribed and administered
bendroflumethiazide before the results of the blood tests were known, something
which the expert witness at the inquest described as contraindicated.

e the hospital laboratory only ‘flags-up’ the blood results if the blood- calcium levels
exceed 3.5mmol/l or more of serum calcium. The expert witness thought that this
should occur at levels of 3.0mmol/I, and that this should be the national standard.

e you were told that a new electronic system of note keeping is being introduced at
Stockport and throughout the NHS. You consider it would be helpful if that system
had an in-built ‘flag’ which highlighted to a doctor that he or she was prescribing
drugs before the requested blood/urine test results had been received.

¢ there seemed to have been a very subjective interpretation of the Early Warning
Scores (EWS) at the hospital by using the ‘manual’ assessment method. You were told
that an electronic version is being rolled out and you hope that this could be sooner
rather than later as it would give a better and more objective assessment of the Early
Warning Scores.

We have sought advice from the National Institute of Health and Care Excellence (NICE)
concerning the first two issues above.

On your concern about the prescription of bendroflumethiazide, NICE confirm that the
clinical circumstances outlined in your report are not currently covered in any published
NICE guidance. However, NICE will be developing a guideline on renal stones, which is yet
to be commissioned.

In response to your concerns about the reporting of blood test results, NICE do not stipulate
laboratory reference values or ‘flags’ on when to alert clinicians to blood test results. As this
is not something that falls within NICE’s remit, it is for individual NHS Trusts to review
their own standards.

With regard to the third concern above, I assume you are referring to the Summary Care
Record (SCR). I can confirm that flag system functionality is not within existing
requirements for the SCR system nor are there any current plans for SCRs or SCR systems to
introduce “an in-built ‘flag’ which would highlight to a doctor that he or she was prescribing
drugs before the requested blood/urine test results had been received. This is a matter best
left to the clinical and professional judgement of the doctor involved, with first-hand
knowledge of the patient’s circumstances.

Regarding the last point, it appears that you are referring to errors in calculating the overall
Early Warning Score (EWS) from its individual components such as pulse, blood pressure,
respiration rate, etc. Electronic hand-held devices are one potential solution to avoid error,
as they can automatically alert medical or co-ordinating staff that a patient’s score has
exceeded a threshold. Staff training and better-designed paper charts, that make areas of
concern visually obvious, are also helpful.

Even when the EWS has been correctly calculated, clinical interpretation is still essential. All
other aspects of the patient’s condition need to be taken into account in order to judge what
clinical actions are needed in each individual case.

A range of resources are already available to help all organisations implement reliable use of
EWS. The Royal College of Physicians (RCP) have led the development of a new National
Early Warning Score (NEWS) which sets a clear national standard for the assessment and
response to acute illness:

http://Avww.replondon.ac.uk/sites/default/files/documents/national-early-warning-score-
standardising-assessment-acute-illness-severity-nhs.pdf

The NEWS described in these resources is in line with NICE recommendations on the care
of acutely ill patients in hospital which can be found in their guideline, CG50:

http://www.nice.org.uk/CG50 .

NICE confirm that, whilst physiological examinations should be made and a clear written
monitoring plan developed, there is no recommendation for the use of one model over
another.

Instead the choice of a physiological track and trigger system should involve multiple-
parameter or aggregate weighted scoring systems, which allow a graded response. NICE do
specify that the scoring systems should:

Define the parameters to be measured and the frequency of observations

Include a clear and explicit statement of the parameters, cut-off points or scores that
should trigger a response.

You may be interested to note that NICE also has a number of guidelines in development
relating to various groups of acutely ill people in hospital:

http://www.nice.org.uk/guidance/indevelopment

As part of this work, N ICE is likely to consider whether there is sufficient evidence for
recommending electronic hand held devices over other methods of calculating the EWS.

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

beak rs,

V

DR DAN POULTER