DHF

1. DHF Presentations 2004 to 2008 +44(0)1423 506 848 +44(0)789 907 4881 Kent House 42 Duchy Rd Harrogate HG1 2ER www.directhealthfirst.com

2. Specialist Registration Non Approved Colleges RCs New Provider Bid UK Graduates GMC NCSC GMC TC FullRegistration EU Graduates Surgery Training with Supervision Approved Colleges

3. Performance Management & KPIs • KPIs • SUIs • Outcome measures DHF

4. CSS v CPS • The CSS contains everything that should help us specify our procurement safely for the NHS • The CPS only contains that which we consider essential to the ITT and which will deliver a VFM bid

5. Input and process specifications • So the sponsor can integrate ISTC care with the rest of the health economy. • e.g. what is expected from the provider may differ between one cholecystectomy package (with a very limited follow up) and another.

6. When things go wrong Difficult to justify protocols which are contrary to UK best practice (without evidence base) which leads to unnecessary conflict with national standards organisations • when (not if) there are unacceptable fatalities • legal consistency across England (Clapham Omnibus)

7. Input and process specifications • Some procedures require specific data for national registers and these have to be specified • e.g. NCEPOD • Cataract National Dataset • e.g. National Joint Registry

8. Outcomes The difficulty with outcome(s) is that the results should be attributable to the treatment

9. Measures • KPIs • 25 ISTCs • NHS TCs • Outcome Measures • NHS TCs • ISTCs

10. Fear of clinical incompatibility

11. KPIs, Clinical Outcomes and JSR process • Commercial KPIs devised by commercial and clinical team working with commercial lawyers • Hence strong clinical element • Consultation with, support of (not approval) • PCLs • RCLs • SHAs • JCC • Cleared in house & sent to be incorporated in contract July 2004

12. Clinical Outcome measures • Indicators invited from • RCs • Other professional bodies • Providers • SHAs • Indicators trawled from literature • Collated set discussed with stakeholders • Final set to stakeholders including JCC • Agreed by board of ISTC programme

13. Quality • Surgeons and accreditation • Moving on to post-operative care • Pathways, continuity and CPS

14. Credentialing • GMC • People • Specialist Register • Training • Buildings, equipment, consumables • Facilities • HCC • Organisation • systems, information, registration

15. Governance • OCT’s & ISTC’s • Local ad hoc schemes

16. Note to Table 1 – the presence of an asterisk in the first column denotes that the relevant Performance Indicator is a Starred Performance Indicator

17. [1] Management plan requirements to be set out in Schedule 3

18. [1] e.g. Anaesthesia Start – Time when a member of the anaesthesia team begins preparing the patient for an aesthetic. Procedure/Surgery Start Time – Time the procedure is begun (e.g., incision for a surgical procedure, insertion of scope for a diagnostic procedure, beginning of examination for an EUA, taking x-ray for radiologica procedure). Procedure/Surgery Finish – Time when all instrument and sponge counts are completed and verified as correct; all post-op radiological studies to be done in the operating theatre are completed; all dressings and drains are secured; and the surgical team have completed all procedure-related activities on the patient. Discharge from Post Anaesthesia Care Unit – Time patient is transported out of PACU (for inpatients). OR Discharge from Same Day Surgery Recovery Unit – Time patient leaves SDSR, either to home or other facility (for day cases).

19. [1] These need to be specified when PCPs completed eg for cataracts, visual acuity is likely to be a relevant clinical outcome.

21. Prostate:International Prostate Symptom Score [IPSS] • pre- and • post-op, • timings to be confirmed [patient administration as good as physician administration (Plante M et al. Urology, 1996;26:326-328)]

22. Cataract: VF-14 Visual acuity • Cataract surgery • pre-op and • 6 weeks post-op Note that ISTC providers are also required to collect and report the Cataract National Dataset

23. Cholecystectomy:Leeds Dyspepsia Questionnaire • @ pre-op • @ OP assessment), and • @ 3 months post-operative Questionnaire[1] • Moayyedi S et al. The Leeds Dyspepsia Questionnaire: a valid tool for measuring the presence and severity of dyspepsia. Aliment Pharmacol Ther, 1998;12:1257-1262

24. Carpal Tunnel:CTS Questionnaire • CTSQ: • @ Pre op • @ Post op assessment • @ 1 year post-op • Pre-op scores provide information about thresholds at which listing decisions are made, (which may be relevant to PIs #5 and #6 conversion and rejection) • Carpel Tunnel Assessment Questionnaire[1] [1] Bessette L et al. Comparative responsiveness of generic versus disease-specific and weighted versus unweighted health status measures in carpal tunnel syndrome. Medical Car,e 1998;36(4):491-502

25. Hip replacement:Oxford Hip Score Clinical outcome to be before/after comparison • OHS: • @ Pre op • @ Post op assessment • @ 1 year post-op Pre-op scores provide information about thresholds at which listing decisions are made, (which may be relevant to PIs #5 and #6 conversion and rejection) • ISTCs also to collect and report data on hip replacements as required by the National Joint Registry

26. National Joint Registry data: (8 February 2004) • Total number of individual patient episodes, submitted electronically: 45,214 records • Contributors since 1 April 2003: • NHS Trusts (England only): 126 • NHS Hospitals (England only): 162

27. TKR: Oxford Knee Score Clinical outcome to be before/after comparison • OKS: • @ Pre op • @ Post op assessment • @ 1 year post-op • Pre-op scores provide information about thresholds at which listing decisions are made, (which may be relevant to PIs #5 and #6 conversion and rejection) • ISTCs also to collect and report data on hip replacements as required by the National Joint Registry

28. Diagnostic procedures • endoscopy, colonoscopy, arthroscopy etc. • Questions: • whether a diagnosis was made • whether the diagnosis made was correct 10% sample of referring clinicians to be asked for views (post-discharge) as to: whether the diagnosis was made; whether, in the event, it was (or appears to have been) correct; Note that: PI#17 captures timeliness, completeness and accuracy of provider clinician reporting to referring clinician

29. Excision biopsy • All procedures involving excision biopsy • Complete removal of tumour or % incomplete removal of tumour on histology report

30. All surgery: blood loss during surgery • blood loss during surgery • thresholds set by reference to average blood loss in restricted number of procedures

31. Overall achievement of objectives • To what extent did your treatment achieve what you expected from it? • Measured on all patients, at 6 weeks post-surgery • at the same time as EQ5D • incorporated into patient satisfaction survey instrument when eventually agreed • providers be required to record the objectives of treatment agreed with the patient at the time informed consent

32. Problems • To what extent did your treatment cause problems you did not expect? • Measured on all patients, at 6 weeks post-surgery (at the same time as EQ5D and incorporated into patient satisfaction survey instrument when eventually agreed) • Providers be required to record the advice on likely side effects and problems of treatment with the patient at the time informed consent

33. Unexpected need for medical attention • Did you need to contact the ISTC, your GP surgery, or other health facility/professional other than by prior arrangement? • Measured at 6 weeks (as above) • Compared to what you expected, did you have more: • discomfort? • pain? • leakage of fluid from the wound? • bleeding? • limitation of normal activities?

34. EQ5D

35. ISTC ProgrammeTCs Patient Flow Diagram New Provider Assessments (Outpatients) (£A) + - diagnostics Diagnostics (direct access) OP Consultation OP Follow-up D B C A New Provider Surgery (FCEs) (£S) EssentialOP follow- up as required + diagnostics - Discharge to NHS - GP - Intermediate Care - Subsequent necessary care GP Consultation with Patient Pre-opAssessment Surgery& Recovery Acute Inpatient Follow-up ? E NHS OP Consultation (and waiting list)

37. f

38. Joint Service Reviews • actions agreed at previous meetings • routine data, identification of any problem areas, and agreed actions • ad hoc reports and the results of any investigations, identification of problem areas, and agreed actions • figures for the ISTCs concerned, compared with other ISTCs; • all findings from reviews of random case records • presentation by the provider to the sponsor of the results of their clinical audit

39. Triggers for review

40. Consequences of review

41. Perceptions of quality risk • National govt. • Local Govt. • Providers (new territories) • Investors (due diligence) • Professions (mixed interests) • Media • Public

42. What Procedures can be ‘safely’ performed in the setting? not associated w/ excessive blood loss &/or fluid shifts do not require higher specialized operating equipment or intensive post-op care; post-op pain manageable take a “reasonable period of predictable time” the‘ultimate’ determinant: clinician comfort level

43. What Patients? • few standardized guidelines • no multi-centre studies; paucity of large prospective studies • Mayo Clinic Study 1984: ASA III no higher risk in a Surgery Centre • FASA 1987: survey of 87,000 patients, questioned relationship between pre-existing disease and peri-operative complications • There is some empiric evidence of certain “patients at risk”

44. Patients at Risk • “complex morbid obesity/complex sleep apnoea” • potential for airway problems, dysmorphic facial features, severe rheumatoid arthritis, • extreme age (?) • poor physiologic condition: ASA III+/IV • history of problems with anaesthesia (MH history) • Acute substance abuse

45. The goal of any pre-op system “Reduce the morbidity of surgery & return patient to normal functioning as quickly as possible.”

46. Risk Classification The Johns Hopkins Risk Classification System

47. 18,189 elective cataract patients: no significance differences between the no-testing & testing groups in the rates of Intraoperative events. Schein OD, et al. The Value of Routine Preoperative Medical Testing Between Cataract Surgery. NEJM 2000; 342: 168-175 Group of 606 patients, 386 chest x-rays ordered without indication…Among these patients, one with abnormality that ‘may’ have resulted in improved care….the existence of three patients with lung shadows led to three sets of invasive tests, including one thoracotomy, but no discovery of disease Roizen MF, et al. The relative roles of the history and physical examination, and laboratory testing in preoperative evaluation: the “Starling” curve in preoperative testing. Anesthesiol Clin North Am 5:15, 1987. After careful medical history, patients undergoing minimally invasive surgery have little benefit from testing…..30 day morbidity after surgery no different than living 30 days without surgery. Narr BJ, et al. Outcomes of patients with no laboratory assessment before anesthesia and a surgical procedure. Mayo Clin Proc 72:505-509, 1997

48. Pre-Op Testing: a sample matrix for minimally invasive surgery

49. Surgery Centre Pre-Op Testing: On-Site • Electrocardiogram • Haemoglobin • Glucometer • Urine Pregnancy Test

50. The process of the screening process is a crucial first step that allows for the provision of safe, effective, and efficient medical care……The development of preoperative evaluation systems in response to outpatient and same day admission surgery provides the challenge of organizing services into formal systems with guidelines formulated on the basis of mutual agreement and established clinical practice…… it is imperative that the anesthesia staff reach a consensus on significant preoperative evaluation issues and adhere to them in dealing with patients and surgeons and associated organizations. Conspicuous or consistent deviation from these practices will only serve to undermine the confidence of all the parties……… Anesthesiologists, in setting up their systems, are well advised to allow for a measure of flexibility. While adhering to a strong standard of care, reasonable judgement in providing that care is preferable to unyielding policies. Ambulatory Anesthesiology: A problem oriented approach L. Reuven Pasternak, M.D., Chapter 1, Screening Patients: Strategies and Studies.