Caroline Dinenage Minister of State for Care Department of Health & 39 Victoria Street London SWIH OEU Social Care 020 7210 4850 Our reference: PFD 1138998 Ms L Hashmi HM Area Coroner; Manchester North Coroner's Service Phoenix Centre LICpl Stephen Shaw MC Heywood OLIO ILL 5 September 2018 Ns haglki Thank you for your letter of 28 June to the Department of Health and Social Care about the death of Mr Stephen Whitehead. I am responding as Minister with portfolio responsibility for hospital care quality and patient safety: I was extremely saddened to read of the circumstances surrounding Mr Whitehead's death: If you have the opportunity, please convey my sympathies to his family. I can appreciate this must be a difficult time for them. Your report was issued to the British Society of Gastroenterology (BSG) and [ understand the Society has provided a response: You will therefore be aware that after careful consideration; the Society is of the opinion that a national stent registry is not required, instead pointing to the existing guidance available and the need for clear communication between medical professionals and with the patient, as well as the clear recording of next steps in management plans. This view is supported by the National Institute for Health and Clinical Excellence (NICE) which out that in this case there appeared to be an intention to remove the stent but this did not happen due to an administrative Way points

error; It is not clear how the establishment of a national stent registry would have avoided the sad outcome in this case where there were apparent shortcomings in the local arrangements for care [am informed that the Pennine Acute Hospitals NHS Trust has since established an ERCP (endoscopic retrograde cholangiopancreatography) biliary stent oversight meeting which has overseen an in-depth review of the current system of following up patients after having an ERCP and stent insertion. Amongst other actions, this learning is shared across the Northern Care Alliance (the Salford and Pennine NHS trusts) to support & review of the management and follow up of all implantables. This is encouraging to see and you will know that the BSG and its Joint Advisory Group are in discussion concerning the addition of a stent planning Or recall database to the performance indicators within the national standards framework; and incorporating it within the Improving Safety and reducing Errors in Endoscopy programme In addition, the BSG is proposing that a plan for a repeat ERCP (in for example, three to four months' time) is set at the time of the ERCP. While this appointment might need to be re-scheduled in light of circumstances, it may act as an important *safety net'_ On your second matter of concern relating to the definition of *short term in clinical guidance, my officials have sought the views of NICE. As you may be aware, NICE issued clinical guideline 188 on Gallstone Disease: Diagnosis and Management'= in October 2014. This includes the following advice: *If the bile duct cannot be cleared with ERCP, use biliary stenting to achieve biliary drainage only aS a temporary measure until definitive endoscopic or surgical clearance' NICE advises that the definition of 'short term is understood in the field and appears to be been understood by the team caring for Mr Whitehead, as had planned to remove the stent after a few weeks NICE therefore considers that the recommendations in NICE guideline 188 remain appropriate. In conclusion, I am satisfied that there is consensus that a national stent registry is not required and that best practice guidance is available: Iam also assured that the BSG has carefully considered the matters raised in your report and will take forward action where it considers it appropriate: https: WWW nice Org uklguidance cg|88 being key - they

Importantly, will know from the BSG 's response that there is a national initiative, Getting it Right, First Time? , that aims to improve the quality of care through the reduction of unwarranted variations in practice. There is gastroenterology workstream led by a clinical lead and the focus will be on disseminating best practice and reduce variations in clinical quality, efficiency and productivity. For completeness, NHS Improvement has brought the concerns in your report to the attention of the GIRFT clinical lead for gastroenterology, Dr Beverly Oates: Thank you for bringing your concerns to our attention: CAROLIE DINENAGE MP http: gettingitnghtfirsttime coukl you

Executive Summary  

Response to Coroners Regulation 28 Report Request: Stephen Whitehead RIP. 

The BSG notes HM Coroner’s request under Regulation 28 and is pleased to file the attached  response on behalf of the Society. 

Expert opinion is provided by the Endoscopy Section of the BSG, taking views from individual  national experts. In response to your questions we note: ‐ 

1) Biliary stenting is common and there are consensus guidelines on good practice  produced by the BSG, NICE and other bodies. 
2) Levels of expertise and local practices vary within guidance (dictated by local expertise  and systems and services) 
3) This case highlights the need for basic adherence to the principle of definitive bile duct  stone clearance which should be the goal in all patients: long‐term stenting is not  appropriate except in circumstances of extreme comorbidity. 
4) There will be variation in the approaches to bile duct clearance and timing of surgery  between Units (expertise dependent) but this should not preclude  a) clear communication between medical and surgical teams (if necessary through a  formal MDT process)  b) clear communication with the patient and patient’s family of the management plan  c) clear recording of the next step of the technical pathway by the ERCPist performing  the stent insertion (backed up by a robust record of stent placement and the interval  and need for patient recall) 
5) In the views of the Society a National Stent Registry would not contribute to the above. 

Separately we should point out that reduction in variation in practice is one of the objectives  of the Get It Right First Time (GiRFT) initiative. The first National Gastroenterology Lead for  this is now in post and will be working closely with the BSG on matters of best practice and  reduction in practice variation. 

Dr Cathryn Edwards MA D.Phil FRCP  BSG President 

Re: Stephen Whitehead DOB 18/04/1960 died 08/02/2018 at The Royal Oldham Hospital 

Whilst the devastating outcome for Mr Whitehead is unusual we recognise that the bile duct  stone disease is the most common indication for the more than 50,000 ERCPs performed in  the UK each year, of which a significant proportion will result in the insertion of a biliary stent.  The use and monitoring of biliary stents is therefore an important issue for patients and  endoscopy  service  provision.    Following  consultation  with  colleagues  within  the  BSG  important we feel that there are a number of issues raised, for which we also have proposals: 

1. Communication.  It  is  not  clear  from  the  details  provided  whether  clear  and  explicit  written information was provided to the patient, GP, and surgical team that a stent had  been  inserted,  the  necessity  of  subsequent  removal,  and  the  timeframe  for  this  to  happen. In writing to endoscopy units/BSG members we will emphasise the importance  of this measure, and the need for a clear directive on every ERCP report which (as is  standard) is given to each patient and their doctor. 

2. Ownership of management. A well recognised issue within ERCP practice is a perception  (and perhaps reality) that the ERCPist is doing the procedure ‘for the surgeons’, with  overall  management  (beyond  the  ERCP  itself  and  immediate  post‐procedure  period)  remaining  the  responsibility  of  others.  This  is  understandable,  given  that  on‐going  decisions  concerning  timing  of  cholecystectomy  or  other  biliary  surgery  will  directly  impact on timing of (or need for) further ERCP. The summary of the case alludes to this  issue, and may certainly have been an issue in the patient being lost to follow up. We  propose that a plan for repeat procedure (e.g. at 3‐4 months) should be set at the time of  ERCP. Whilst this may need to be cancelled/amended, according to the unpredictable  nature of changing patient circumstances (e.g. intervention, comorbidity), it may act as  an important ‘safety net’ 

3. Database of stents. We completely agree that a clear record of when a stent has been  placed, and when this should be removed or changed, is important. We feel this should  be within the ownership of the endoscopy unit that has inserted the stent. This may be a  formal database or a facility within the electronic endoscopy reporting tool, but should  be contemporaneously entered at the time of the ERCP, with a clear plan as to timeframe  for patient review/repeat procedure. Crucially the system should allow easy, rapid and  demonstrable review of all patients who have undergone stenting within an extended  time period.  

After careful consideration, we do not feel that the answer is a national database of biliary  stents.  This  would  be  unwieldy  and  require  significant  additional  manpower  and  infrastructure to police. The vast majority of patients will have their care in one locality  and, as suggested in the report, shortcomings in local arrangements of care, including  communication  between  local  teams,  GP  and  patient,  were  the  fundamental  issues  highlighted  here.  Although  the  National  Endoscopy  Database  (NED)  has  now  been  introduced nationally, it is important to record that this does not allow individual patient  tracking, and could not act as a proxy database of biliary stents. The BSG and JAG are  however in discussion concerning adding the use of a stent planning/recall database to  the  key  performance  indicators  (KPI)  within  its  national  standards  framework,  and  incorporating  it  into  the  ISREE  (Improving  Safety  and  reducing  Errors in  Endoscopy) programme.  This  topic  will  be  formally  discussed  at  the  BSG  Endoscopy  Committee in October. 

4. Overall  management  of  complex  biliary  stone  disease.  Although  not  specifically  addressed in the coroner’s report we would raise a concern that the patient’s disastrous  outcome with respect to cholangitis/retained stent and ‘lost to follow up’ relates in part  to  the  overall  management  of  complex  stone  disease.  It  appears  that  the  patient  underwent a lap chole with a 'large gallstone' still within the bile duct, which would be an  unusual  approach.  It  is  not  clear  from  the  report  that  there  was  an  overall  plan  of  management to address removal of the bile duct stone. Recent BSG and NICE guidelines  on gallstones make it clear that definitive bile duct stone clearance should be the goal in  all patients, and that long‐term stenting is not appropriate except in circumstances of  extreme comorbidity. This is supported by published data. With the increasing availability  of advanced techniques to achieve stone clearance, and all hospitals now sitting within  HPB networks, all patients with complex stone disease should be referred to a centre  experienced in management, if not available locally. 

We would be extremely happy to discuss these issues further, but hope that they address  many of the concerns raised by the coroner.