Prevention of Future Deaths reports · 2017

Sarah Kiff

Regulation 28 report to prevent future deaths, reference 2017-0407, written 20 Nov 2017. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report20 Nov 2017
Reference2017-0407
DeceasedSarah Kiff
CoronerLisa Hashmi
Coroner areaManchester North
CategoryCommunity health care and emergency services related deaths
Sourcejudiciary.uk record · original PDF
Responses published1

The report

Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.

REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1)
REGULATION 28 REPORTTO PREVENT FUTURE DEATHS
THIS REPORT IS BEING SENT TO:
1. , Senior Partner, Stonefield Street Surgery, Rochdale
I CORONER
I am Ms L Hashmi, Area Coronerfor the Coroner area of Manchester North.
2 CORONER’S LEGAL POWERS
I make this report under paragraph 7, Schedule 5, of the Coroner’s and Justice Act 2009 and Regulations 28
and 29 ofthe Coroners (Investigations) Regulations 2013.
3 INVESTIGATION and INQUEST
On the 2th0 October 2015 I commenced an investigation into the death of Sarah Kiff. This investigation
was concluded by way of inquest on the November 2017.
4 CIRCUMSTANCES OF DEATH
In January 2013 the deceased presented to her General Practice with a vaginal discharge. Antibiotic treatment was instigated. She
re-attended end January 2013 with urinary symptoms aiid was seen by’ a different doctorwho instigated further antibiotictherapy. A
swab wasdirected and aurinesample wassentfortesting.
On the 8th February the deceased re-attended the practice and was seen by a third doctor. On this occasion she presented with a
history ofheavy menstruation for the past 6 months, ongoing lower abdominal pain and vaginal discharge. A full gynaeco!ogical
historywasnottaken, agynaecological examination was notconducted norwerearrangements madeforthe same to becarriedoutat
another time. Such an examination was necessary so as to ensure no obvious abnormalities and in order to visualise the cervix.
Further antibiotics were prescribed and an ultrasound scan requested. The scan ultimately proved negative but would not, in any
event, have shown any disease process within the cervix. The deceased was not referred to a gynaecologist for further testing or
opinion.
On the 22nd Februarythedeceased was seen by a locum GP who furtherprescribed topical antibiotics. Again, afull gynaecological
history was not taken and a gynaecological examination not conducted in order to check for abnormalities. The doctor had been
falsely reassured by’ the ultrasound scan result, the result ofwhich was conveyed to him by the patient ratherthan by way offormal
reportingat thetime.
On the 11th July2013 the deceased presented with ongoingurinary’ symptoms. Antibiotics were prescribed and a swab directed. On
the 18thJuly, shewasseen byanotherdoctorwhomade an urgentreferral to agy’naecologist.
Following colposcopy and biopsy, a diagnosis of squamous cell carcinoma of the cervix (6 cm) was made. Subsequent scans
identified livermetastases. Thiswas an unusual presentationofmetastaticdisease. Itwasnotpossibleto operate uponthedeceased
nor to cure her condition by this stage however treatment was afforded in the form ofchemotherapy and radiotherapy’. Initially the
deceased made good progress however by May 2015 further physiological complicationsarose. Treatment and general declinetook
theirtoll.
Onthe 14th October2015 thedeceasedwasseen bytheoutofhours GP, followingtheresultofa lowbloodcount. Shewasadmitted
to Accident and Emergency. Shortly thereafter, she suffered a cardiac arrest. A cycle ofadvanced life supportlCPR was carried out
beforethe decision was madeto discontinue. Thedeceased died atFairfield General Hospital laterthe same day.
NICE guidance had not been followed and communication asto the GP/s requirement regarding vaginal examination bythePractice
Nursenotspecifically conveyed.
Whilstthe evidence disclosed gross failures to provide basic medical care, on a cumulative basis, causation could not be established
tothe required legal standardofproof.
Though chemotherapy contributed to the deceased’s decline, the direct cause ofher death was the normal progression ofa natural
illnesshaving run itsfull course.
It was not possible to say, on the evidence heard, whether earlier diagnosis and intervention would have materially altered the
outcome.
I reached aconclusion ofnatural causes.
5 CORONER’S CONCERNS
During the course of the inquest the evidence revealed matters giving rise to concern. In my opinion there is
a risk that future deaths will occur unless action is taken. In the circumstances it is my statutory duty to
report to you.
The MATTERS OF CONCERN are as follows:
1. GPs at the Practice did not follow the NICE 2005 cancer referral guidance. This puts patients at
risk.
2. Medical record keeping and communication between the medical and nursing teams was poor.
The doctor/s were not explicit about what they required the nurse to do in terms of P.V.
examination and made assumption that the nurse/s knew what the doctors expected ofthem.
3. There was lack of continuity of care and a failure by doctors to fully appraise themselves of the
clinical history ahead of consultation. The care provided to Ms Kiff was, on occasions, perfunctory.
4. During the course of the evidence it became apparent that male doctors were reluctant to carry
out internal examinations on female patients as they felt it more appropriate for their female
colleagues to do them. Reluctance was not related to patient preference (in this case the patient
was not offered any such examination). Moreover they felt that female doctors were, skill wise,
more able.
5. The processes and procedures in place for reviewing test results and ensuring that they appear
within the patient’s electronic records appears to be inadequate.
6 ACTION SHOULD BE TAKEN
In my opinion action should be taken to prevent future deaths and I believe each of you respectively
have the power to take such action.
7 YOUR RESPONSE
You are under a duty to respond to this report within 56 days of the date of this report, namely by the 1th5
January 2018. I, 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.
8 COPIES and PUBLICATION
I have sent a copy of my reportto the Chief Coroner and to the following Interested Persons namely:
• The deceased’s family
• MDU acting on behalfof Locum GP)
• Rochdale CCG
• CQC
I am 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 ChiefCoroner.
Date: 2th0 November2018

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 Stonefield Street Surgery (PDF)
Stonefield Street Surgery
Stonefield Street, Milnrow, Rochdale, 0L16 4i0
Tel: 01706 646234 Fax: 01706 527946
Ms L Hashmi
Area Coronerfor North Manchester Area
HM Coroner’s Court
The Phoenix Centre
L/Cpl Stephen Shaw MCWay
Heywood
0110 1LR 08January 2018
Dear Ms Hashmi,
Re: Regulation 28 Report to prevent future deaths
Thank you for your regulation 28 letter dated 2l November 2017 which relates to Miss Sarah
Ktff. This lady was well known to the partners and staffat Stonefield Street Surgery followingthe
diagnosis of advanced cervical cancer back in July 2013 and through her subsequent diabetic
and palliative care reviews until she sadly succumbed to the cancer in October 2015. I am
responding on behalf of the practice to the five concerns you raise. I will demonstrate that the
events surrounding both the diagnosis and death of Miss Sarah Kiff, have been discussed
through significant event analysis and as a result, we have developed better pathways and
protocols within the practice. I will demonstrate that we have tried as a practice to learn from
what has happened and we continue to learn from it.
I will discuss the points raised in turn:
1. 61’s at the practice did not follow NICE 2005 cancer referral guidance:
The practice has produced an annual audit report around new cancer diagnoses for
several years, with the records of each patient being reviewed by a clinician looking to
see if there were any lost opportunities to diagnose the condition earlier and to ensure
NICE guidance was correctly followed. These CancerAnalysis Audits are discussed at the
clinical governance meetings and any learning points are shared within the practice
team.
A review of Miss Sarah Kiff’s notes was undertaken on 1th4 October 2013 by Dr Lynn
Hampson. It was recognized during the audit that at diagnosis Miss Kiff had Stage 4
disease with liver metastases. The history showed that she first developed symptoms of
urinary infections and vaginal discharge in early 2013; however no formal pelvic
examination had been undertaken. The doctors had been reassured because of a high
vaginal swab confirming infection and a negative Ultrasound Scan. Unfortunately, there
was then a gap of nearly five months before Miss Kiff represented with urinary
symptoms and discharge and within a week of that presentation she was referred
urgently to see a Gynaecologist.
The cancer analysis was discussed by the clinicians and it was recognized that there had
been no examination by a doctor as per NICE guidance CG27, although a HVS had been
undertaken by an experienced practice nurse. thought that this was
undertaken using a speculum with visualization of the cervix, and nurses agreed it was
standard practice to take a HVS using a speculum to visualize the cervix, but at the time
there was no practice protocol describing these expectations. Male GPs described how
they were feeling less confident in performing pelvic examinations compared to their
female colleagues due to the infrequency with which it was required in a practice that
has three female GPs, a nurse practitioner and three practice nurses. At that time, it was
agreed that any female patient needing assessment who had presented to a male
doctorthat had concerns about theirskills in examination, would be handed overto one
ofthe female GPs. Similarly, where male patientsfelt uncomfortable about having pelvic
examinations performed by a female GP, then the same onward referral protocol would
be followed. This agreement has been in place since October 2013. More recent
discussions have also concentrated on the methodology for taking high vaginal swabs
following your comments, and it has been reconfirmed that these are all done using
cervical speculums, so that the cervix is visualized during the test. Any abnormality
found by the nursing staffwill be highlighted to one ofthe GPs. The practice now has an
agreed protocol for performing HVS.
Following these initial discussions, sent a letter to the scan providers,
Lancaster House, dated 1th4 October 2013, asking that the consultant
review the ultrasound scan from Feb 2013, as the partners were concerned that a 6cm
cervical lesion with metastases, diagnosed in July would probably have been visible in
the February. No response was received. wrote again on 2th7 May 2016,
but no response has been received from the provider to either ofthese letters. This was
raised in a Quality Feedback form to the primary care department of HMR Clinical
Commissioning Group.
In July 2015 new cancer guidance NG12 was produced by NICE. These were discussed
within the practice meeting, with each partner being provided with copies of the
Macmillan summary guidance and copies ofthe BMJ flow chart which are laminated and
on the wall of each consulting room. The deputy Practice Manager now ensures that all
new NICE guidance is shared with clinicians monthly via email and the lead clinician in
the relevant area is responsible for ensuring that any new recommendations are shared,
and protocols altered where necessary. This process has now been in place for over 2
years.
2. Medical record keeping and communication between the medical and nursing teams
was poor. The doctors were not explicit about what they required the nurse to do in
terms of PV examination and made assumptions that the nurses knew what was
expected ofthem.
All nurses within the practice receive training in performing swabs and doing vaginal
examinations as part of the competency for gaining certification for the taking of
cervical smears, using vaginal speculums. The current nursing team have described that
they do use speculums to undertake HVS and where possible do visualize the cervix
asking a GP to review if there are any abnormalities seen. However it has not been
standard practice to document this in detail when taking a swab and it has now been
agreed that more detailed records will be written noting if the cervix has been seen as
perthe new protocol. All four ofthe current nursingteam are experienced practitioners
and have been performing such examinations for many years. who
performed the original HVS 5 also likewise experienced and we would have expected
her to raise a concern had she seen any abnormality during the examination. The GP
did assume that having a HVS meant that the cervix had been visualized. Following your
regulation 28 letter, the doctors and nurses have reaffirmed the intention for all HV
swabs to be performed with direct vision ofthe cervix so that it is clear what is expected
when a patient is referred for a swab. Likewise, it has been agreed that instructions for
other diagnostics are also to be written clearly within the records and that patients are
made aware of how these results can be accessed.
Review ofthe medical records for Miss Kiff has highlighted that the record keeping was
not adequate, and this has allowed the clinical staff to review the method for clinical
note recording, ensuring in future that more detailed records are kept. Each clinician has
now reviewed the GMC guidance on record keeping in Good Medical Practice (2013) at
paragraphs 19-21.
3. There was lack of continuity of care and a failure of doctors to fully appraise
themselves ofthe clinical history ahead ofconsultations.
Patients registered with the practice can book with any GP and therefore have the
ability to see the same doctor if they so wish. This is generally encouraged by the
doctors as it improves continuity of care. Miss Kiff chose to see different GPs and
therefore there would have been some loss of continuity with the doctor having to
revisit the clinical history on each occasion. Whilst it is the responsibility of all clinicians
to ensure they are apprised of any relevant clinical history, due to the pressures of
general practice and the limited consultation time it is sometimes difficult to he fully
aware of the finer details of past medical history. Each patient will have a summary of
significant clinical history which is easily visible at the start of a consultation in the
clinical records,
Due to increasing complexity of many patients, the practice has altered consulting
schedules so that blocks between every few patients allow the doctor time to ensure
they are up to date with past and current clinical problems for each patient, The blocks
result in the standard appointment time of 12 minutes instead of 10 minutes. I have
already alluded in sections 1 & 2, to processes now in place to ensure that clinical
records are more accurate and that the relevant examinations are performed.
4. During the course ofthe evidence it became clearthat male doctors were reluctant to
carry out internal examinations on female patients as they felt it more appropriate for
theirfemale colleaguesto dothem.
The practice has already instituted mechanisms to ensure that female patients needing
intimate examinations can, where preferred, be referred to a female colleague for this
to be done. This is described under point 1.
As an additional learning action, the practice has been able to get the support of
a Gynaecology Oncologist at Pennine Acute Trust, who has agreed to
provide a training session for the clinicians at Stonefield Street Surgery in early 2018
around the recognition of Gynaecological malignancies and management of female
problems. Some ofthe male partners are also looking to attend local Gynaecology clinics
to help improve their competency in vaginal examinations.
5. The processes in place for reviewing test results and ensuring they appear within the
patient electronic records appearto be inadequate.
All test results relating to Miss Sarah Kiff are clearly visible within the patient electronic
record. The EMIS computer system records date test requested date received, date of
review and filing as well as any practice notes made by the doctor. The report
comments on the Ultrasound Scan result for Miss Kiff, but the records clearly show that
the report was received on the 2th5 February, seen and noted to be normal and filed in
the patient record, so this was unfortunately not available for her appointment with Dr
Vounison 22’ February 2013. This is all auctitable within the clinical system.
The practice has robust processes in place to ensure all diagnostics are actioned on the
same day of receipt and where there is an abnormal result that these are followed up
with the patient. The GP can readily look in the clinical records to review why the test
was performed. On most occasions the GP who orders the test will be reviewing the
results, but this is not always possible due to patterns of working. In addition, some
providers return results tothe registered GP ratherthan the one requestingthe test.
The practice protocol has been designed to ensure that where a result needs follow up
the patient is made aware. The original protocol dates from December 2015 but this has
recently been updated. Patient follow up is managed either through a practice note
asking the administrative team to arrange a further appointment or the result being
passed on to the relevant clinician. These actions are all auditable within the clinical
records ofthe patient. The practice protocol describes that when tests are taken it isthe
responsibility of each clinician to make the patient aware of the intentions around
actions following the diagnostics. It is a general rule that normal results are not notified
to patients, however patients are asked to phone to learn the results of any tests and
the clinicians receiving these will add a comment and file the report within the patient
record. Where a normal result is received many patients are still seen for follow up.
In this response, I trust that I have provided reassurance that the practice has put into place
robust processes and proceduresto ensure that diagnoses are not delayed.
To summarise, the learning and actionstaken are as follows:
• The practice has put into place mechanismsto ensurethat NICE guidance is followed
• The practice continues to perform monthly CancerAnalysis Audits for all patients newly
diagnosed with cancer and discusses any learning points within practice meetings
• All NICE guidance is reviewed monthly and disseminated to all clinicians
• The practice has a new written policy around methodology for undertaking HVS and the
recording offindings
• A new policy has been created that describes internal referral processes between
clinicians where there is a more appropriate professional to perform either an
examination or procedure
• Record keeping: All Doctors have refreshed their knowledge of paragraphs 19-21 of the
GMC’Sguidance GoodMedicalPractice, which describes good record keeping
• Dr Schaefer is providingtraining to all clinicians on Gynaecological malignancies
• Some male GPs will undertake upskilling in female pelvic examination techniques
Miss Kiff was added to the Gold Standard Framework (palliative care register) in November
2013 and her care was regularly reviewed in the monthly multidisciplinaryteam meetings, with
several members of the extended team providing support during her ongoing therapy with The
Christie Hospital. In addition, the practice performs a review of all patient deaths, and this was
done following the death of Miss Kiff, with learning points being raised through the
multidisciplinary meeting that happened coincidentally on the same day as Mrs Kiff died. The
team members were all saddened that her last moments were not as discussed within her end
of life plan.
I trust also that I have provided you with evidence that the practice has reviewed the care
provided to Miss Sarah Kiff, and that we have learnt from what happened and put into place
procedures to address the issues you raise. We continue to review our protocols and procedures
to ensure the safety of patients, with robust processes in place to identify and learn from
significant events.
Yours sincerely
Senior Partner

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