1. How quality assurance can help counter fraud in endoscopy Roland Valori Gastroenterologist National Clinical Director for Endoscopy November 2010

2. Plan of presentation Describe: –what we do in endoscopy –what quality colonoscopy looks like –my perspective on fraud –our quality assurance framework Reflect –on what made an impact Speculate –on implications for HICFG –on how we can help each other

3. Today

4. White light NBI Dye application

5. Flat lesions and EMR

6. Colon cancer Screening leads to a 15-18% reduction in death from cancer

7. Colonoscopy prevents cancer: A 50% reduction in incidence is possible

8. Cumulative incidence distal cancer (%) - RCT of flexible sigmoidoscopy screening

9. Smoothed yearly hazard rates for distal cancer (rectum and sigmoid colon) £60 million for a national FS screening programme

10. Flexible sigmoidoscopy screening Reductions in risk CRCCRC death Left sided CRC Right sided CRC ITT 23%31%36%2% Per- protocol 33%43%50%3% all cause mortality reduction of 3%

11. Colonoscopy screening Colonoscopy has no influence on right sided cancer

12. One reason why:

13. Would you be prepared to have a colonoscopy done by a colonoscopist selected at random?

14. Who would you choose? Private colonoscopist selected at random? NHS colonoscopist selected at random?

15. Who would you choose? Because many private endoscopists: –dont monitor their performance –decisions are influenced by reimbursement Private colonoscopist selected at random? NHS colonoscopist selected at random? Why?

16. Colonoscopy activity: Australia/England Australia 2007/8England 2008/9 Totalrate/1000/yrTotalrate/1000/yr Colon - private402,20336.5 Colon - public118,11110.7350,8757.0 Assuming an Australian population of 22 million and 50:50 private:public split

17. Over servicing – the million dollar colonoscopist Endoscopist has just done his tenth colonoscopy of the morning with deep sedation but, yet again, with incomplete mucosal visualisation: –Didnt get to the caecum –Poor prep –Didnt turn the patient –Came out too fast But he found a couple of small polyps –so he is able to schedule another procedure

18. Feedback to the patient The good news for you is no cancer found, the bad news (good for me) is you will need another procedure……. Now the guidelines say you dont need another procedure, or at least not for 5 years, but then the guidelines are influenced by costs and I have seen cancer appear, even in so called low risk categories…. So we better repeat the procedure in a year

19. Guess what? Cancer found at splenic flexure Arent you pleased we paid no attention to those Government- sponsored money-saving guidelines?

20. EU bowel cancer screening quality assurance guidelines - surveillance chapter 9 Recommendations: 9.19 Every screening programme should have a policy on surveillance. The policy may limit surveillance to the highest risk group if sufficient resources are not available to include people with lower risk (VI B) 9.21 Adherence to the guideline should be monitored (VI A) 9.22 Surveillance histories should be documented and the results should be available for quality assurance (VI A)

21. Validation of surveillance procedures Measure 5.9 endoscopy Global Rating Scale: All surveillance procedures are validated clerically and clinically according to the latest guidance at least two months prior to the due date Yes No April 2010 census

22. Colonoscopy: quality and safety ExpertInexpert Completion>95%<90% Adenoma detection>20%<20% Completeness of polyp excisioncompleteoften incomplete Cancer miss rate1%10% Perforation rate<1:5000>1:1000 Serious polypectomy complications<1:500>1:100 Patient experienceusually goodoften bad Appropriateness of repeatsyesoften no

23. Colonoscopy: quality and safety ExpertInexpert Completion>95%<90% Adenoma detection>20%<20% Completeness of polyp excisioncompleteoften incomplete Cancer miss rate1%10% Perforation rate<1:5000>1:1000 Serious polypectomy complications<1:500>1:100 Patient experienceusually goodoften bad Appropriateness of repeatsyesoften no

24. How should colonoscopists be monitored? Key performance indicators: –polyp detection rate –comfort –completion –non technical skills –use of sedation –appropriate surveillance intervals Polypectomy KPIs –removal technique used –completeness of excision –retrieval rate –use of tattoo –complications –rates of cancer in surveillance patients Colonoscopists who monitor and, when necessary, act on these parameters are less likely to be committing fraud

25. Who would you choose? Surgeon colonoscopist selected at random? Physician colonoscopist selected at random? BCSP nurse colonoscopist selected at random? Australia 2010

26. Who would you choose? Surgeon colonoscopist selected at random? Physician colonoscopist selected at random? BCSP nurse colonoscopist selected at random? what would the public think? Australia 2010

27. What is fraud? Cheating the insurer and the insured Knowingly not providing an acceptable standard of care Not providing an acceptable standard of care Supplying faulty goods

28. investment output = net benefit x fraud

29. The patients view of endoscopy 2001 Chaotic Long waits Poor communication Poor environment Poor experience Thanks to Dr Bill Goddard Nottingham University Hospitals

30. Modernisation agency (England) 2001 2002 2003 2004 2005 2006 2007 2008 2009 pilot work National Endoscopy Programme

31. 2001 2002 2003 2004 2005 2006 2007 2008 2009 spread 28 regions 18 weeks BC screening endoscopist training programme pilot work

32. Endoscopy units Professional bodies Community services Private sector Regulatory bodies Key relationships in 2009 JAG Endoscopists DH Training centres policy quality delivery

33. Professional bodies Quality assurance infrastructure 2010 JAG Joint Advisory Group on Gastrointestinal Endoscopy Physicians Surgeons Nurses GPs Radiologists Paediatricians

34. Professional bodies Regulatory bodies Quality assurance infrastructure 2010 JAG Department of Health

35. Quality assurance subgroups Professional bodies Units Regulatory bodies Quality assurance infrastructure 2010 JAG Individuals Department of Health Training HICFG ?

36. Quality assurance of units Endoscopy Global Rating Scale Peer review accreditation

37. What would matter to you if you were having an endoscopy? Endoscopy Global Rating Scale (GRS) 2004

38. Patient-centred standards - endoscopy global rating scale ·Clinical quality appropriateness information/consent safety comfort quality timely results www.grs.nhs.uk Quality of patient experience equality timeliness choice privacy and dignity aftercare ability to provide feedback

39. GRS - Levels for Safety item Level D –Adverse events reviewed Level C –Adverse events are acted upon Level B –Action is monitored for effectiveness Level A –Prospective monitoring of >5 known adverse events www.grs.nhs.uk

40. GRS - Levels for Quality item Level D –Quality and safety indicators are available Level C –Indicators are monitored Level B –Indicators are reviewed and action planned if performance is below the standard Level A –Indicators show that action taken to address performance issues is successful www.grs.nhs.uk

41. D C B A 1 2 3 4 5 6+ Items Each item has five levels A*- D Each level is underpinned with 1-4 measures 1 2 3 Global Rating Scale (GRS) framework The patient experience Domains 1 2 P www.grs.nhs.uk

42. GRS measures – two questions Would I want this in place if I was a patient? Do I have this in place in my service?

43. GRS item 11 – Aftercare – levels C and B LevelsMeasures AftercareAftercare Level C Patients are discharged with procedure- specific aftercare information and knowing whether there is concern about malignancy. Patients have a 24 hour contact number if they experience problems There are procedure specific aftercare patient information sheets for all procedures performed in the department There is a 24 hour contact number for patients who have questions and experience problems All patients are told if they are suspected of having a malignancy on the same day as the procedure If it is considered inappropriate to tell the patient malignancy is suspected, a note is made in the file of the reason Level B Patients are discharged knowing the outcome and future plans. Not all patients leave with an appointment when one is required All patients are discharged with verbal and written information about next steps appropriate for their care All patients are told the outcome of the endoscopic procedure prior to discharge All patients are told if further information from pathological specimens will be available, from whom and when Patients views on aftercare processes are sought at least annually

44. Answer: yes or no Responses define the level: all measures up to and including that level have to be achieved to score that level www.grs.nhs.uk Quality of the patient experience Web-based reporting

45. The GRS is an on-line check list of 149 measures: 12 items in two domains. Each item now has 5 levels InadequateDMinimal achievement BasicCReactive GoodBProactive ExcellentAOutward looking ExemplaryA*Able to support others Level B is the current standard There are two further domains: workforce and (registrar) training

46. % scoring A or B GRS – National results one item - nine censuses over 4.5 years (212 units) this slide is the key for the next two level A or B is the current standard Consent and patient information 2005 2006 2007 2008 2009 Oct Apr Oct Apr

47. % scoring A or B Completion rates of eleven censuses Clinical quality 85%94%100%97% 98% 99% 96% 2005 Apr Oct 2006200720082009 97% Apr Oct 99% Apr 2010 GRS Results : April 2005 – April 2010

48. % scoring A or B Quality of the patient experience GRS Results : April 2005 – April 2010 85%94%100%97% 98% 99% 96% 2005 Apr Oct 2006200720082009 97% Apr Oct 99% 2010 Apr Completion rates of eleven censuses

49. Adopting the GRS first awareness established practice contemplation preparation action maintenance awareness Effective Health Care 1999;5(1) doctorsnurses

50. Clinical response to the GRS XXXX City Hospital When I first saw the GRS I have to be honest and say that I printed it, read it, ripped it up and chucked it in the bin I had no intentions of ever doing anything with it. Slowly I saw what was going on around me and I had another look. I now truly believe that its been the single most important thing that has helped us to improve our service. I feel somewhat embarrassed at my initial reaction. Endoscopy Unit Clinical Lead

51. The GRS in Canada CAG Consensus Conference on Safety and Quality Indicators in Endoscopy, Toronto, June 2010

52. Endoscopy waits Jan 2007 – Dec 2008

53. Median waiting times for endoscopy up to Feb 2010 Median has dropped from 8.7 weeks in April 2006 to 2.1 weeks in February 2010 for colonoscopy; 6.5 weeks to 2 weeks for flexi sigmoidoscopy; 6.3 weeks to 2.2 weeks for cystoscopy; and 6.3 weeks to 2 weeks for gastroscopy

54. Final Wave Pennine Lancashire Berkshire North Staffordshire South Essex Surrey Sussex Bristol & Weston North Essex Bath, Swindon & Wiltshire Bedfordshire Cheshire Calderdale, Kirklees & Wakefield East Kent North & East Devon Harrogate, Leeds & York Peterborough & Huntingdon West Kent & Medway Hereford & Worcester Buckinghamshire Cornwall Shropshire Manchester Lincolnshire Oxford Second Wave Heart of England Coventry and Warwickshire Bradford & Airedale West London Cambridge County Durham & Darlington Leicestershire, Northampton & Rutland South East London North of Tyne South Yorkshire Dorset West Hertfordshire East & North Hertfordshire Nottinghamshire Hampshire Cumbria & Westmorland Sandwell & West Birmingham Somerset First Wave Wolverhampton Norwich South Devon Cheshire & Merseyside St Marks South West London Gloucestershire Bolton Tees South of Tyne Humber & Yorkshire Coast Derbyshire North East London Solent and West Sussex University College London 58 Bowel Cancer Screening Centres

55. Bowel cancer screening programme SC Programme Hub: (FOBT) colonoscopy site persons aged 60-75 screening centre x 58 x5x5 X 100 + +ve test accreditation visit 76,434 colonoscopies done to date

56. process What and who are assessed? Pre-procedure - indications - consent - bowel prep, etc Post-procedure - recovery - patient advice - follow-up, etc Endoscopists performance data staff environment kit GRS

57. Accreditation visits Peer review process –Nurse: decontamination, workforce, environment –Endoscopist: training issues –Endoscopist: service issues Accreditation based on a validated GRS score for service, workforce and training domains: –A for timeliness (< 6 weeks) –B for all other items The process is supported by an on-line accreditation system designed to manage the process of accreditation, to upload evidence and to communicate with sites

58. GRS Measures Evidence required Upload your evidence Communicate with assessors

59. North Tyneside - JAG accreditation visit (provides secondary healthcare for population of 850,000) Ive written to the chair of the JAG separately about the exemplary quality of the process – if only all of the regulatory processes were this good. The really striking (and humbling) thing though was the way yourself and the whole team have grasped the issue, driven massive improvements in a very short space of time and really transformed the service for patients. Jim Mackey Chief Executive

60. Targets for JAG visits All acute hospital sites (209) - visited by April 2011 All private and community facilities (circa 250) - testing of process completed by 31 Dec 2008 - visits completed by 31 December 2012

61. Acute sector accreditation: service and training - peer review visit TotalVisitedPassedDeferredFail 209187 (89%)148372 6 have definite dates between now and December 14 have agreed with the JAG to fix a date for the first half next year 2 are being approached: little coming back

62. JAG accreditation of IS endoscopy Visit costs are currently £5,000 for a single site centre. Charges cover administration, reimbursement of assessors and travel costs. Feedback (acute sites) indicates the cost of a visit is more than offset by the benefits of going through the process Assessment is supportive and educational Accreditation will reassure a provider it is providing high standards of care Its really hardwork getting there but worth every second of it Care UK Its really hardwork getting there but worth every second of it Care UK

63. Traditional private hospitals Require modified GRS Often gold standard patient pathway Often part of theatre Future of endoscopy in some providers is an issue Quality and safety audits a huge challenge Ideally need to see NHS and private data combined

64. Traditional private hospital – facilities and nursing issues Often older facilities Decontamination issues as per NHS Mainly theatre nursing with endoscopy as sub specialty Generic workforce to cover patient journey No emergency care issues Pleasant, relaxed patient experience with one to one consultations

65. What made the difference? 1.Having a clear goal 2.Defining a good patient experience 3.Aligning agendas 4.Clinical engagement 5.Support tools and knowledge 6.Listening and responding to the service 7.Using available levers 8.Intensive support 9.Support for the workforce 10.Peer review accreditation

66. Speculate

67. Potential markers of fraudulent endoscopists High volume privately and low volume in NHS High volume in a session (>6 in four hours) Use of heavy sedation Low completion rates Does not follow guidelines on repeats Short intervals between repeats Resistance to participating in quality assurance Fails to monitor performance Resistance to responding to poor performance

68. Commissioner Family doctor Patient Commissioner Family doctor Patient Acute Hospital unit all providers measured against the same standards Using the market to sustain and improve quality Community hospital unit Private hospital unit Training centre unit GRS + accreditation

69. Quality assurance subgroups Professional bodies Units Regulatory bodies Quality assurance infrastructure 2010 JAG Individuals Department of Health Training HICFG

70. How can we help each other? 1.Having a clear goal 2.Defining a good patient experience 3.Aligning agendas 4.Clinical engagement 5.Support tools and knowledge 6.Listening and responding to the service 7.Using available levers 8.Intensive support 9.Support for the workforce 10.Peer review accreditation