Dear Miss Kearsley Re: Bryan Herbert WHITBY (deceased) Thank you for your letter of 25 March 2015. instructed the clinical team to review the case and have set out the answers to the points noted in the Regulation 28 notification below. The deceased had been unwell for some time ad had a history of Chronic Kidney Disease (CKD) Hethad been referred for & CT scan but the GP Practice were not aware of the date of the scan or that this would take place on 03 May 2014. The Directorate Manager for Radiology has advised that Radiology would not normally inform a GP of scan dates or send the results to them unless they were the referring Clinician: The scan was requested on 29 April 2014 by Surgical Registrar; in the lower gastrointestinal clinic (GI) The GP does need a complete picture of what investigationslprocedures a patient has had as part of their secondary care episode but this would be communicated to the GP in a letter from the Specialist once all investigations were complete_ Blood tests taken on 02 were not escalated by the GP or the Pathology Laboratory, and the on 03 May went ahead while he was still receiving Metformin medication: The scan out the scan did not have accese to his Sbiooacesug fromo62 Mayeadasimply TenRadioleges_ gesuitsrryorg the GP referral some time ago from The Radiology Lead for Trafford Division has advised that their policy at that was to check the most recent blood results within three months. The blood results reviewed were the most recent at the time were checked and had been taken on 24 April 2014, which was nine days prior to the scan: At this time; the eGFR result was 71 and there was no indication in the information the Radiology Department received that there was any concern over Mr Whitby's renal status The Surgeon recorded on the referral form for the CT scan with contrast that Mr Whitby's eGFR was 71 and that he was taking Metformin for his Type Il diabetes. These eGFR results did not cause concern as were well within the Royal College of Radiologists and NICE guidance for giving contrast whichs is 60/ for intravenous contrast and 60 for stopping Metformin: The Radiology Department were unaware of the further blood tests taken at the GP Practice on 02 2014, Whilst these results were available on the same on the Electronic Patient Record RzeivE 36 "K May Stage May the time they they May day

(EPR) the Radiology staff would not have routinely looked for further results at that time unless had been informed that there had been change in Mr Whitby's condition: Given the short time between Radiology booking and scanning Mr Whitby, they did not look again on the system. As a result of this incident; the Radiology Department have reviewed their practice in relation to the and assessment of renal function to intravenous contrast administration. Following this review they have implemented process to check for any later results prior to giving contrast injections for CT scans as a routine protocol for all patients with known CKD_ am sorry but there is no record of who requested further blood tests on 06 May 2014_ On the morning of 06 2014, Mr Whitby's blood tests from 02 May 2014 (eGFR 40 and Creatinine
148), were checked by the GP and the drop eGFR and magnesium_ and the raised Creatinine were noted, The GP contacted the Locum On Call Medical Registrar at Trafford Hospital, and asked advice advised that further bloods needed to be taken that morning and ifno improvement; to reier i0 the Acute Medical Unit (AMU) at Trafford General Hospital: Mr Whitby then had some further blood tests taken at the GP Practice which arrived at the Pathology Laboratory at Trafford Hospital at 14.27 hours on 06 May 2014. At approximately 12.00 hours on 07 2014, Mr Whitby's GP reviewed his blood results and noted his eGFR was 11 and Creatinine 448 which can indicate Stage 5 CKD_ Mr Whitby's GP contacted the Locum Medical On Call Registrar at Trafford Hospital, Iwho accepted Mr Whitby for admission to the Acute Medical Unit (AMU): Icompleted a GP referral proforma and recorded clinical details of Acute Kidney Injury (AKI) or Chronic Kidney Disease (CKD) with drop in eGFR on the GP referral form: The GP Practice contacted North West Ambulance Service (NWAS) at 12.29 hours to arrange for them to collect Mr Whitby and bring him to the AMU. The results of the blood tests on 06 should have resulted in urgent discussion with the Mr Whitby's GP or Mr Whitby himself: There was no escalation of these results by the Biochemistry Laboratory. Mr Whitby's blood results were not escalated by the Chemical Pathology Laboratory on 06 May 2014 as the SOOumolL threshold followed in the Laboratory at that time for Creatinine had not been breached. Chemical Pathology have now lowered the telephoning limit for Creatinine results from 50Oumol/L to 40Oumol/L and these results are telephoned through on the same Consultant Chemical Pathologist, Chief Biomedical Scientist in Chemical Pathology, have confirmed that a review of Ineprocesses' for urgently notifying GPs of abnormal test results has been undertaken: On 09 March 2015, the Biochemistry Department went live with an Acute Kidney Injury (AKI) alert system: In future all Stage 3 alerts will be telephoned as soon as possible on the same day. Stage and 2 alerts will be reviewed on a case by case basis. Despite blood results, Mr Whitby was not admitted to hospital as an emergency and there was a in recognising the seriousness of these results_ Training for junior members of staff on AKI has now been delivered: When Mr Whitby was admitted into hospital, there was a failure by the treating medical staff to recognise his serious medical condition and then a failure to carry out the required medical treatment The high level investigation into the care and treatment of Mr Whitby acknowledges that the severity of his illness was not recognised by the admitting team in the AMU until he became clinically unweli. Due to this; he was not appropriately managed on admission. Following the high level investigation , a detailed action plan was agreed and progress was monitored via the Divisional and Directorate Clinical Effectiveness Committees All actions are now complete. The Trust's AKI guidelines, which support the recognition of severity and the management of AKI in line with NICE guidance August 2013, have been fully implemented and are clearly displayed on the Information Board and in the Doctors' office on the AMU. The guidelines are also now included in the Handbook provided to Locum Doctors_ they prior timing May May May day: land] delay

Medical and nursing staff on Acute Medical Unit attended a debriefing session to discuss the care treatment of Mr Whitby and the lessons learned. His case was also presented to medical staff at Medical Grand Round and was presented more widely at the Divisional Audit and Clinical Effectiveness (ACE) day on 17 October 2014 The case was presented by Consultant, who discussed the missed opportunities and the chain of events The preseniation 0f Mr Whitby's case was followed by a presentation by Consultant in Nephrology and Intensive Care Medicine, who explained to staff how Ine Trust Ts lacklng AKI explained how AKI was a safety priority_for the Trust and also explained the role of the Renal team and of the AKI Specialist Nurses_ also discussed the AKI e-alert system which at that time was under development but has since been successfully implemented Trust wide Mr Whitby's case has also formed a important part of lessons learnt teaching for Junior Doctors across the Trust and this was followed by teaching of the recognition and management of AKi: The Inquest also heard evidence that Mr Whitby required transfer to the High Dependency Unit but this could not take place immediately as two Critical Care Nurses were required and one had been sent to Manchester Royal Infirmary as was the practice if there were no patients in the HDU at the start of their shift: Since the date of the incident regarding the transfer of Mr Whitby to the High Dependency Unit; two Critical Care Nurses have been on site at Trafford at all times The Critical Care Service has reviewed the use %f Trafford s High Dependency Unit'and is wedeninga thearecopevifor hne repenty patients who can be nursed there in the future_ This means that not only will the Critical Care Nurses be based on the Trafford site they will be based at all times on the High Dependency Unit hope this letter answers your concerns and gives you and Mr Whitby's family assurance that lessons have been learned.

Dear Joanne Kearsley Mr Bryan Whitby DOB: 10/07/1926 NHS No: Telephone No: Thank you for your letter dated 25h March 2015 with your report regarding investigation into the death of Mr Bryan Herbert Whitby (deceased). First of all we would Iike to clarify the detail regarding Mr Whitby's renal function blood results_ He was diagnosed with chronic kidney disease stage 3 on 31 January 2013 due to deterioration in his kidney function: At that stage his eGFR had dropped to 34mls per minute_ However; this improved over next few weeks up to the mid 50's. On 7th April 2014 it was 60. In general practice it is quite common to see a reasonable amount of variation in the eGFR test and he had had several blood tests done in order to monitor_ this_ Mr Whitby made telephone appointment at the practice and spoke to on 6 who noticed that a blood test taken on 2na May showed a drop in Tis 8GFR rom 60mls per minute_(creatinine 1O5umol/L) to 4Omls per minute (creatinine 148umol/L) He had already had his CT scan at that stage. Our records show Mr mentioned that his diarrhoea had improved and confirmed that he hadn't stopped his metformin, also according to contemporaneous notes documented at the time, Mr Whitby's records also confirm that spoke to the on-call medical registrar at Trafford General Hospital in order {0 opialm aqvice due to her concern about the drop in eGFR_ The medical registrar advised to prescribe oral magnesium supplements for week due to his low magnesium and suggested that he may need intravenous magnesium and if he did not improve the blood test should be repeated When he 130 Broadway, Davynulme, Manchester M4 7WJ Telephone 0844 489 0845/0161 748 5559 Fax 0161 747 1997 Kdalyhulmemedicalcentre co-'k Email: dzkyhulmemedicelcentre@nhshet CENTRE the May Whitby

Was asked foradvice regarding his medication, particularly the furosemide, the registrar advised Ito leave this at the current dose_ Regarding the matters of concern raised in your letter: As a GP practice we are not usually informed of dates that patients are given for their investigations bv the hospital unless the patient happens to mention this during & consultation with the GP. We were therefore not aware of the date of his CT scan:
2. The audit trail of the blood tests confirms that the renal function result was sent to the GP practice automatically on Friday 2nd May at 14.03. However this was not seen by_ to whom it was allocated until Tuesday 6"h at 9.30am due to this being a bank weekend. Mr Whitby's case was discussed at Significant Event meeting at the practice and has been further discussed by the GP's and managers in recent weeks. Attached is bullet point list of the actions that we have and will undertake related to this. In line with normal practice the Primary care sector we have not in the past had a policy of checking result across that it arrives We have felt that there was strong argument to maintain a level of on the day care with results seen by the GP who has ordered them but we have now continuity of reviewed this policy in light of Mr case The practice relies upon the lab to phone through any abnormal results if urgent attention is required. These are then passed onto the on call doctor and are dealt with on the It was not felt practical to be able to guarantee to check all results as come in Neither this nor the subsequent kidney function result was phoned through &8 Cogenuousve We understood from the hospital critical incident report that the lab at Trafford General was of this and would be reviewing this system: It was also felt that in view of previous aware renal function to a lower level of 34 which had subsequently recovered _ most of drop in the GP's felt they would have arranged to repeat the blood test in the first instance. clinical biochemist at Trafford General Hospital has confirmed that the protocol at this time was to telephone practices if a creatinine result is above 50Oumol/L The eGFR is a calculated number derived from the creatinine, an indicator of kidney function: It was also clarified that as practice we are not able to see results put on to the system automatically unless we search for them on named patient basis tee hospital not automatically know about abnormal results in the hospital therefore: In factl who noted the abnormal results did ring the medical registrar to obtain further advice As result of the significant event meeting it was agreed that ali GP's would read the NICE Guidance on acute kidney injury to improve our management and awareness of this condition in the future. The need to tconsider stopping medication potentially toxic to the kidney in high risk patients was highlighted, as was the need to check blood results on daily basis to avoid missing abnormal results_ The GP's are aware of the need to consider a potential diagnosis of acute kidney in risk Patients and {0 discuss with the renal {eamofethey haeany concefegkregerding potehiga acute kidney injury: 130 Broadway; Davyhulme, Manchester M41 7WJ Telephone 0844 499 0845/0161 746 5559 Fax 016i 747 1997 WVW davyhulmemedicalcentre couk Email: davyhulmemedicalcenire@nhahet May holiday every being Whitby's day: they laboratory injury

3. Arepeat blood test result for kidney function requested by arrived at the practice on 7th May 2014 and was assigned to at seven 0 clock in the morning: This was viewed by lat one o'clock in tne aiternoon and he discussed this with the medical registrar at Trafford General Hospital. In view of a further drop in eGFR to 11mls per minute, he arranged for an ambulance to take Mr Whitby to Trafford General Hospital. 4 The patient was admitted as a matter of urgency when who viewed the results, clearly recognised their seriousness. Since this case occurred, in response to an NHS England Patient Safety Alert to tackle acute kidney injury an electronic alert system has been introduced nationally in adult patients which was introduced locally on 9 March 2015. This will help to highlight future sudden reductions in kidney function Yours sincerelv 130 Eroadway , Davyhulme . Manchester M41 7WJ Telephore 0844 490 0845/016i 748 5559 Fzx 016i 747 1897 JWd-whulmenedicekcentre c24k Email: ikvhumemecicslcenice@uhale