Prevention of Future Deaths reports · 2017
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 report | 20 Nov 2017 |
|---|---|
| Reference | 2017-0407 |
| Deceased | Sarah Kiff |
| Coroner | Lisa Hashmi |
| Coroner area | Manchester North |
| Category | Community health care and emergency services related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 1 |
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
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.
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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