Report on patients whose cancer pathway was over 91 days Study 2

Transcription

1 Report on patients whose cancer pathway was over 91 days Study 2 Main authors: Dr Penny Newman, Amanda Dell, Ayo Adebamowo Contributors: Ian Craddock, David Traynier, Orla Thunder, Michelle Fisher, Lorna Dewar, Hether Buckle, Sandra Lyons, Dr Mary McStay, Dr Devy Basu, Dr Jennifer Collins, Denise Gale Executive Sponsor: Dr Sean MacDonnell

2 Final Report for IMT This report was commissioned by Colchester Hospital University NHS Foundation Trust at the request of the multiagency incident management team (IMT). Dr Christine Macleod, on behalf of the Assurance Panel of the IMT, endorses the findings within this report. Signature: Date: 16/12 /2014 Dr Christine Macleod, Medical Director NHS England, Essex Area Signature: Date: 16/12 /2014 Dr Lucy Moore, Chief Executive Colchester Hospital University Foundation Trust. 1

3 Our gratitude goes to the following: Colchester Hospital University NHS Foundation Trust Main authors: Dr Penny Newman (Review Programme Director, Director of Service Integration, GP and Consultant in Public Health), Amanda Dell (Project Management Consultant), Ayo Adebamowo (Lead Cancer Information Analyst) CHUFT Contributors and Review Team members: David Traynier (Audit support/analysts), Lorna Dewar (Oncology Clinical Trials Manager), Orla Thunder (Clinical Trials Data Nurse), Michelle Fisher (Research Nurse), Ian Craddock (Site Matron, Senior Auditor), Heather Buckle, Sandra Lyons (Clinical Auditors), Dr Mary McStay, Dr Devy Basu, Dr Jennifer Collins (Lead Clinicians), Denise Gale (Cancer Programme Director), Valerie Northcroft-Brown (Project Support) Executive sponsor: Dr Sean MacDonnell (Medical Director) Business Informatics team and in particular Michele Figg (Head of Business Informatics) Health Records team and especially Barry Moult (Head of Information Governance & Health Records),Teresa Frost (Health Records Manager) and Phil Frances (Health Records Clerk) The Assurance Panel Dr Christine Macleod (NHS England Essex Area Team Medical Director and Chair of Retrospective Assurance Panel), Dr Shane Gordon (Clinical Chief Officer, NHS North East Essex Clinical Commissioning Group), Karen Hindle (Senior Associate (communications) interim hub manager, North, Midlands and East Communications), Dr Thomas Nutt (Chief Executive Officer, Healthwatch Essex), Paul Pharoah, (Professor of Cancer Epidemiology, Department of Public Health and Primary Care, University of Cambridge and Honorary Consultant in Public Health, Public Health England), Pól Toner (NHS England Essex Area Team Director of Nursing and Quality). Observer: Representatives of the Information Commissioner s Office, Support: Christine Cooper (PA to NHS England Essex Area Team Medical Director) External reviewers The East of England Strategic Clinical Network, particularly Dr Rory Harvey (SCN Cancer Clinical Director) and Kate Patience (Rehabilitation & Quality Improvement Lead for East of England SCN Cancer Team), all the external review Consultants and Karen Harland (Cancer Services Manager, HOPE Clinical Unit, Hinchingbrooke Health care NHS Trust) The Royal Marsden NHS Foundation Trust and particularly Nicky Browne (Director of Performance & Strategy Implementation) 2

4 Contents Abbreviations and Acronyms Used in this Report... 4 Cancer Waiting Times Guidance (V8.0)... 5 Executive Summary... 6 Introduction... 6 Summary of results... 6 Discussion and conclusion Introduction Methods Results Data Accuracy and Length of wait Final assessment by auditors Cause of delay Sample on CWT tool but not on open Exeter Impact on patient outcomes Areas identified for improvement from qualitative analysis Discussion and conclusion Recommendations APPENDICES Appendix 1 Long Waits Study Protocol Appendix 2 Methodology Appendix 3 Glossary and Codes Appendix 4 Final assessments of multidisciplinary clinical panel reviews Aggregate of final assessments of CWT expert reviews

5 Abbreviations and Acronyms Used in this Report 2WW Two Week Wait CCG Clinical Commissioning Group CHUFT Colchester Hospital University Foundation Trust CNS Clinical Nurse Specialist COSD Cancer Outcome and Service Dataset CQC Care Quality Commission CUP Cancer of Unknown Primary CWT Cancer Waiting Times DNA Did Not Attend DTT Decision to Treat ECAD Earliest Clinically Appropriate Date ECRIC Eastern Cancer Registration and Information Centre FDT First Definitive Treatment FT Full Time GDP General Dental Practitioner GI Gastro-Intestinal GMP General Medical Practitioner GP General Practitioner IMAS Interim Management and Support IMT Incident Management Team IT Information Technology MD Medical Director MDT Multi-Disciplinary Team MDTC Multi-Disciplinary Team Coordinator MEHT Mid-Essex Health Trust NAO National Audit Office NE North East NEE North East Essex NHS National Health Service ONS Office for National Statistics OPD Outpatients Department PAS Patient Administration System PH Public Health (England) RMH Royal Marsden Hospital RRT Retrospective Review Team RTT Referral to Treatment SCN Strategic Clinical Network SCR Somerset Cancer Registry TYA Teenagers and Young Adults EUS Endoscopic Ultrasonography SI The definition of a serious incident is: An incident of such seriousness that it causes or threatens to cause serious harm to patients, staff, volunteers, members of the public, contractors or the Trust itself. There are specific criteria used to define SIs and this includes the risk of reputational harm to the NHS. A Never Event is a serious incident which should never happen if known preventive measures had been in place (Series Incident Procedure Trust Policy No 63a, 2014) Please note where an SI is mentioned throughout all reports in the retrospective review this refers to an incident report form (datix) being completed and referral for serious incident investigation. The investigation process can take up to 45 days at which point a final report is submitted to North East Essex CCG for review. Some investigations are still on-going at time of writing this report 4

6 Cancer Waiting Times Guidance (V8.0) Two-Week Wait (2WW) is defined as urgent GP (General Medical Practitioner (GMP) or General Dental Practitioner (GDP)) referral for suspected cancer to first outpatient attendance. Patients referred on this pathway are required to be seen in the Trust within fourteen calendar days from the receipt of their referral. Patients on this pathway are concurrently on both the 62-Day pathway (from receipt of referral) and 31 day 1 st definitive treatment pathway (from Decision to Treat (DTT) 1 ). 31-Day First Definitive Treatment is defined as decision to treat to first definitive treatment. Patients referred under this standard are required to commence first definitive treatment for a new cancer diagnosis within 31 days of the date of decision to treat being made. 62-Day Standard is defined as urgent GP (GMP or GDP) referral for suspected cancer to first definitive treatment. Patients referred with suspected cancer under the two-week wait standard (2WW) are required to commence first definitive treatment, if cancer is diagnosed, within 62 days from the date of receipt of referral for the suspected cancer, and within 31 days of the DTT. The 62-Day Screening is defined as urgent referral from NHS Cancer Screening Programmes (breast, cervical (gynaecological) and bowel (Colorectal) for suspected cancer to first definitive treatment. These patients are required to commence first definitive treatment, if cancer is diagnosed, within 62 days from the date of receipt of referral for the suspected cancer. 31-Day Subsequent Treatment is defined as decision to treat/earliest clinically appropriate date (ECAD) to start of second or subsequent treatment(s) for all cancer patients including those diagnosed with a recurrence where the subsequent treatment is surgery, anti-systemic cancer treatment (drugs), or radiotherapy. These patients are required to commence treatment within 31 days of the date of decision to treat being made or earliest clinically appropriate date. Waiting Time Adjustment (First Seen) records the number of days that patients should be removed from the calculated waiting time for the two week wait period and potentially the 62 day period (if cancer is confirmed). Waiting Time Adjustment (Treatment) records the number of days that should be removed from the calculated waiting time between the date of decision to treat and the treatment start date i.e. the number of days that a clock can be paused for a 31 or 62 day period if a reasonable offer of treatment in admitted care has been declined. Consultant upgrade is defined as 62 days from a consultant s decision to upgrade the urgency of a patient (e.g. following a non- urgent referral) to first treatment for cancer. The non-urgent referral can be upgraded by a consultant (or authorised member of the consultant team as defined by local policy) because cancer is suspected. Downgrade: Two week wait referrals can only be downgraded (taken off suspected cancer pathway) by a GP - if a consultant thinks the two-week wait referral is inappropriate this should be discussed with the GP and the GP asked to withdraw the two-week wait referral status a GP should not be asked to downgrade a patient (or withdraw the referral) simply because they are unavailable to accept an appointment within two weeks. If the patient cannot guarantee attendance for tests or treatment within a certain timescale the patient should not be downgraded. 1 Decision to Treat (DTT) is defined as the date the patient agrees a treatment plan. 5

7 Executive Summary Introduction This retrospective review of cancer care at Colchester Hospital University NHS Foundation Trust (CHUFT) is one of six studies looking at data error, pathways over 91 days ( long waits ), delays in diagnosis, pathway stops in upper gastrointestinal (upper GI) cancer, follow up care in superficial bladder cancer and a review of serious incident investigations (SIs), help line calls and complaints over the period of the Care Quality Commission (CQC) investigation. The aim of this study 2 was to identify all patients who had experienced long waits, the reasons for the delays and take appropriate clinical intervention if required. The audit involved review of 290 records of patients on the cancer waiting times pathway (CWT) between April 1, 2010 and October 31, 2013 whose cancer pathway was over 91 days. This study was a look back exercise considering a specific cohort of patients rather than a random sample and therefore results cannot be generalised to cancer care across the Trust. The background of the retrospective review process including the six stage audit process are described in other studies. Summary of results Between April 2010 and Oct 2013, 4,461 patients were treated for cancer on the 62-day pathway in the 10 tumour sites reviewed of whom 290 (6.5%) waited over 91-days. Urology and lower GI had a disproportionality high number of patients waiting over 91 days. The study looked at how long patients waited after 91 days comparing the CWT tool and notes, given the number of data errors found in other studies. There was a 9% inaccuracy in the overall number of data items measured in this audit (117 of 1,249 verifiable data items) and 71% of patients had errors in at least one data field (165 of 233 cases with complete records), compared to 10% and 55% in the error rate audit respectively. Most (54%) of the dates recorded on CWT tool were before those recorded in the notes, and half were within 5 days (27 of 54 data items). On average, patients in this cohort waited 118 days from referral to treatment using dates from both the CWT tool and case notes. Nine patients in urology waited an extremely long time to be treated (range days). Auditors recorded all potential delay points along each patient s pathway at which a major delay occurred. A total of 687 delay points were identified at four phases in each patient s pathway, the majority occurring in the diagnostic phase i.e. between date first seen and date of decision to treat (71% of delay points, 490 of 687 delay points). The table below lists the main causes for delay, mostly due to problems in booking appointments. Cause Description % delay points Delay in booking appointments An error or hold-up relating specifically to the booking process 27% (185 of 687) National CWT guidance Delay allowed for in the National Cancer Waits Guidance 18% (124 of 687) Delayed/missing Diagnostic procedures that were carried out late or 13% (88 of 687) tests omitted e.g. an ultrasound, tissue biopsy, or endoscopy Patient choice Such as postponing treatment to take a holiday 14% (98 of 687) 6

8 Patient unfit Patients temporarily too unfit to undergo a procedure 6% (42 of 687) or treatment (distinct from having co-morbidities) i.e. from an infection or injury Clinical decision Decision imposed on the process by the responsible 4% (26 of 687) clinician Inadequate capacity Situations when treatment or diagnostic facilities were 5% (36 of 687) inadequate excluding staffing issues e.g. insufficient free slots on a theatre list Other reasons Unclassified 13% (90 of 687) Based on the evidence available from multiple sources overall clinical auditors considered CHUFT internal processes responsible for 57% of all delays (294 of 688 points of delay). Auditors considered about half of the delays preventable (51%, 352 of 687 delay points). Of all the preventable delays, the clinical auditors reported that 86% of delays (301 of 352 delay points) were the result of issues internal to the Trust, 10% (34 of 352 delay points) were due to other Hospitals and 5% (17 of 352 delay points) were due to patient factors. The majority of all preventable delays were in urology (55%, 94 of 352 delay points) and lower GI (20%, 71 of 352 delay points). Nearly a third of patients (31%, 88 of 283 cases) who had waited over 91 days were on shared pathway involving CHUFT and at least one other hospital. Patients were most often on a shared pathway with skin (64% or 9 of 14 cases), lung (61% or 11 of 18 cases) and breast cancers (55% or 6 of 11 cases). In this cohort patients who were treated on a shared pathway waited on average 10 days longer than those on a single pathway between referral and treatment dates. In some of these cases, patients were referred to and from CHUFT after considerable time, often after they had already breached (68%, 19 of 28 cases). Of all 88 cases that were referred between CHUFT and other Trusts where data was available, at least 26% (23 cases of 88 cases) would have been referred after 42 days. For patients who have already experienced delays at their Trust of origin, referral to another Trust adds additional waiting time. A number of cases as well as breaching the 62-day target, also breached the 2WW and/or 31 day targets (76 of 283 cases). For these patients the average wait from referral to treatment was 127 days, 9 days longer than the average wait length of 118 days for the cohort. This illustrates that once a patient has breached either target, the likelihood of meeting the 62 day target is reduced. Auditors assessment Consultant/clinical panel assessment No impact 66% (187 of 283) 90% (255 of 283) Potential harm (clinical and/or emotional) 12% (33 of 283) 8% (23 of 283) - Potential clinical harm 5% (13 of 283) 3.5% (10 of 283) - Potential emotional harm 1% (2 of 283) 1.4% (4 of 283) - Potential clinical and emotional harm 6% (18 of 283) 3.2% (9 of 283) Other e.g. impact unknown 21% (59 cases of 283) 2% (5 of 283) In the majority of cases (66%, 187 of 283 cases), auditors identified no potential emotional or clinical harm, and that 12% of patients (33 of 283 cases) may have experienced clinical or emotional harm or a combination of both. The clinical panel considered 90% of those reviewed had experienced no harm, and overall 8% (23 of 283) of patients may have experienced clinical and or emotional harm. 7

9 The clinical panel also identified a number of patients who had experienced delayed investigations, diagnosis and treatment. The total number of serious incident investigations was 6% or 17 of 283 cases including those already referred at the time of the CQC investigation. Of these 17 cases, 8 were referred through clinical panel or auditor assessment and nine were pre-existing SI cases. Seven cases were subject to rapid action by the Medical Director after the clinical panel meetings. The assurance panel assessed 12 cases of potential data manipulation. In four, there was some evidence of potential data manipulation although none led to delay or caused harm hence none required referral to the police. The following themes were identified from qualitative analysis: Data recording There were examples of incomplete and poor record-keeping as in other studies. MDT discussions were poorly documented at times, with incomplete records. Coordinating Investigations were not sequentially ordered and acted on responsively leading investigations to delay e.g. echocardiogram, axillary biopsy, MRI, flexible sigmoidoscopy, and assessments staging investigations, delay in endoscopy, Endoscopic Ultrasonography (EUS), Uncoordinated and protracted pathways Shared Care - Inadequate Coordination GP/Trust communication Patient Choice Complex patients Urology Upper GI Lower GI delay in requesting bone scans and acting on pathology results. Pathways were not actively managed and patients tracked through the system. Excessive delays resulted from cancellation of appointments by the Trust and patients, delayed diagnostics and pre-operative assessments. Delays were often cumulative, with lack of co-ordination at the beginning of pathways e.g. between diagnosis and MDT discussion, all adding up to substantial delays overall. There were delays resulting from issues of co-ordination and communication between CHUFT and other providers including Broomfield, Addenbrookes, the Brompton and the London, particularly for upper GI. There was evidence of poor GP/Trust communication including on referral, in ordering and using tests and results, and on safeguarding issues. Some patient presented late despite having symptoms for some time and many delays were attributable to patient choice. Patient choice for a pause could be more actively followed up as these often led to disproportionate delays. Delays were most prevalent where patients had multiple co-morbidities, a rare tumour or multiple tumours that required transfer within the Trust between teams e.g. intra MDT referrals and referral for cardiology and anaesthetic assessments, and between hospitals. Their care provided particular challenges but was not expedited. Patients requiring safeguarding did not always have an advocate to manage their appointments. Delays occurred in cancer pathways due to investigations such as MRI for prostate cancer, and for renal cancer, leading to occasional delays in diagnoses. Delay occurred particularly in relation to referral of complex patients to Broomfield for EUS and oesophageal cancer and to the London and St Bartholomew s Hospitals for hepatocellular carcinoma. Delays occurred in diagnostics, pre-op assessments and follow up of patient who DNA. Consistent implementation of the iron deficiency protocol is required with primary care. 8

10 Discussion and conclusion As in other studies, this study also found data inaccuracies within and between the CWT tool and the notes. Given length of wait was an important measure, and to determine if adjustments had been appropriately applied, all patients were identified where an incorrect adjustment would have meant that patients had waited over 91 days. As a result 25 patients were included in the study who did not meet the study inclusion criteria, identified before (14) and after (11) the audit was completed. These patients were included in the analysis as issues were found by clinical auditors and this study was a look back exercise. In each study a proportion of cases were referred by the clinical auditors to lead doctors, all of whom were then assessed by a multidisciplinary panel. Clinical auditors initial assessments e.g. of harm, were higher than the doctors or clinical panel. This is due to inter-observer differences and the clinical panel assessments are likely to be more robust based on multidisciplinary discussion of often complex patients. The report was of a selected cohort of patients and therefore results cannot be generalised. However it shows about 7% of patients on cancer treatment pathways had delays over 91 days at the Trust (on average 118 days) and a small number considerably more. The introduction to CWTs guidance v8.0 (Page 5, para 3) reads It is not expected that all patients will be seen and treated within these time frames. Some patients will choose to wait longer and others will not be clinically able to be seen/treated within these time frames. To take account of this, operational standards have been set that allow for a proportion of patients to breach these standards due to medical reasons or choice. At the time of this study most patients in this cohort were being treated in urology and lower GI. Urology made up the majority of patients (47%) and the long delays can be mostly explained by the prostate cancer pathway where patients had to wait 6 weeks for MRI post biopsy. This was rectified in December 2013 and MRI is now before biopsy cutting waiting times by 6 weeks. However, the MRI and TRUS pathway did not explain all cases in urology where systems of care require review as part of the Essex urology review. Some delays were not preventable, particularly given patient choice and patients being temporarily unfit for treatment. However, the review also shows that improvements need to be made as the majority of preventable delays were within the control of the hospital including delays in booking appointments and due to pending diagnostic tests and results. Firstly, it appears that more capacity is required in the Trust especially in terms of the diagnostics. Most delays occur in the diagnostic phase of the cancer pathway. Secondly, more pro-active management is required of complex patients who transfer between teams i.e. for pre op assessments, and between hospitals. When a patient breaches the 2 week wait and 31 day target any delay may not be recovered, and patients then go onto breach the 62 day target. These patients who breach and/or require transfer to other hospitals need to be prioritised and their pathways, as others, more actively managed along with improved communication on inter Trust referral. 9

11 This study as in others shows considerable error in entries onto the CWT tool. In the total cohort, 44 patients were included whose first definitive treatment records were not submitted to Open Exeter 2 to ensure no eligible patient had been excluded through incorrect CWT adjustments being applied. This cohort included 19 of the 25 patients that did not meet the study inclusion criteria. However, this subgroup of patients were more likely to be on shared pathways, have higher numbers of data errors, include patients with clinical and CWT pathway concerns and have experienced longer waits indicating data quality were worse in this sub group compared to the cohort as whole. The Trust needs to implement clear processes of data validation that would normally precede any submission to Open Exeter. The assurance panel looked at all cases of potential data manipulation (12), including the cases referred to above, and recognised potential data manipulation in eight cases. It is extremely difficult to establish a causal relationship between patient harm and erroneous recording in the CWT tool which is used for performance purposes. Clearly awareness of CWT guidance and data reporting needs fundamental improvement. Clinicians as well as providing clinical leadership particularly in MDT teams and supporting more proactive patient management of pathways need to be vigilant in ordering and interpreting tests responsively, in accurate diagnosis, and providing the most effective, timely and patient centred treatment including early referral to oncology. Summary against objectives Objectives Outcome Measures/Endpoints Primary Objective To identify patients who have experienced long delays within their cancer pathway Between April 2010 and Oct 2013, 4,461 patients were treated for cancer on the 62-day pathway in the 10 tumour sites reviewed of whom 290 (6.5%) waited over 91-days. Patients with long waiting times over this period had cancers mainly in urology (137 or 47%) and lower GI (63, 22%), Secondary Objectives To identify the reasons for the long delays Of 689 delay points, the biggest causes of delays were delays in booking appointments (27%, 185) and due to patient factors including patient choice (14% or 98) and co-morbidities (6% or 42). Patients who had already experienced delays at their Trust of origin, and/or breached their 2WW or 31 day target, were more likely to go on to experience longer delays as delays are cumulative and not recovered. About half of the delays were preventable (51% or 352 of 687 delay points), of which processes internal to CHUFT were responsible for the majority, mostly in urology and lower GI. To ensure appropriate clinical intervention for any identified missed diagnoses Auditors assessed 12% patients as experiencing harm compared to 8% reviewed by the Trusts clinical review panel. Twelve patents underwent new SI investigations, and fifteen overall. In five patients issues were identified which required immediate follow up by the Medical Director with individual clinicians. 2 Open Exeter is a web-enabled viewer from NHS Connecting for Health which gives opportunity to share information (i.e. cancer waiting times, immunisations, and screening) with other organisations including GP Practices, Hospitals and Laboratories. Note, security is of the highest importance and data protection regulations are observed at all times 10

12 To ensure systems / processes exist to prevent any further long delays See report on actions arising from the review and cancer action plan. 11

13 1. Introduction This retrospective review of cancer care at Colchester Hospital University NHS Foundation Trust (CHUFT) is one of six studies on: 1. Data error 2. Pathways over 91 days ( long waits ) 3. Delays in diagnosis in patients on consecutive cancer pathways 4. Pathway stops in upper gastrointestinal (upper GI) cancer 5. Follow up care in superficial bladder cancer and a 6. Review of serious incident investigations, help line calls and complaints over the period of the Care Quality Commission (CQC) investigation. For details on the background to the retrospective review please see study 1 on data error. The retrospective review looked at two aspects of patient care, and any relationship between them: 1. The cancer waiting times (CWT) data pathway to identify data inaccuracy 2. The clinical pathway to identify any potential clinical harm. This study considered mostly clinical pathways and CWT data was reviewed to validate length of wait. 1.0 Study aims This Study 2 aimed to review all patients who entered a cancer pathway at Colchester Hospital University NHS Foundation Trust (CHUFT) between 1 April 2010 and 31 October 2013 where there was a delay from referral to first treatment of 91 days or more. The study protocol was written by the Incident Management Team (CMT) (appendix 1, Table 1). Objectives Outcome Measures/Endpoints Primary Objective To identify patients who have experienced long delays within their cancer pathway Number / % of patients with long delays Secondary Objectives To identify the reasons for the long delays To ensure appropriate clinical intervention for any identified missed diagnoses To ensure systems / processes exist to prevent any further long delays Categorise reasons Appropriate clinical follow-up - remit of Colchester Cancer Incident Management Team Remit of Colchester Cancer Incident Management Team Methods Review case-notes to identify and record on standard pro-forma: a) reason(s) for delay (may involve more than one provider), b) appropriateness of delay, c) any outstanding clinical action required Y/N. Table 1. Objectives of long wait audit as established by Incident Management Group 12

14 2 Methods The audit involved a review of 290 records of patients on the cancer waiting time s (CWT) pathway between April 1, 2010 and October 31, 2013 whose cancer pathway was over 91 days. 2.1 Audit process The Retrospective Review process included 6 stages: Stage 1. Identifying the cohort Stage 2. Developing the audit tool and piloting Stage 3. Undertaking the case note review Stage 4. Clinical and cancer wait expert advice and/or review if necessary Stage 5. Analysis and report writing Stage 6. External review by Consultants and CWT expert of 10% sample of cases organised by the Strategic Clinical Network. 2.2 Data sampling The detailed process to identify the cohort is described in appendix 2. It was not a random sample but a look back exercise to provide assurance through a review of all patients on the CWT pathway for more than 91 days over the study period and who may require further follow up Inclusion Criteria 1. Patients on 62-Day cancer pathways 2. Patients who received first definitive treatment between Apr 2010 and Oct Patients whose cancer pathway originated from or terminated at CHUFT 4. Patients with pathways where period from date of receipt of referral for suspected cancer to start date of first definitive treatment is equal to or greater than 91 days Exclusion Criteria 1. Patients treated outside of the specified date parameter. 2. Patients receiving second or subsequent treatment in the audit period. 3. Patients receiving first definitive treatment but not eligible for inclusion in national 62-day standard report regardless of whether or not the patient waited for 91 days or more. This includes all breast symptomatic referrals and patients submitted to Open Exeter as breaches in excess of 91 days but incorrectly recorded as 2WW Quality Assurance The review was performed in two stages: 1. The initial sample involved case note review of 246 patients who met the inclusion criteria based on records the Trust had submitted to the national Open Exeter system. 2. To ensure all eligible patients were included a further sub set of 44 patients were identified from the Trust s Cancer Information system (CWT tool) who had not been submitted to 3 Section of CWT Reports GFOCWS Report Specification Part 5 stipulates that the 62-day standard report excludes symptomatic breast cancer cases. 13

15 Open Exeter for a variety of reasons and who in some cases had waited over 91 days without an adjustment. 2.3 Audit template and codes (stage 2) The audit tool was made up of seven data fields including referral received date, date first seen, waiting time adjustment (first seen), date of decision to treat (DTT), treatment start date, waiting time adjustment (treatment), and treatment modality. Each case note was reviewed and a set of pre-defined codes applied in order to quantify critical findings, particularly focused on the cause of the delay. A glossary of the codes is given in appendix Case note review (stage 3) Auditors reviewed each case as described in study Assessment of clinical and CWT pathways (stage 4) Patients received a clinical or non-clinical review following auditor assessment and coding where there was concern: Clinical review: All patients coded as potential clinical and/or emotional harm or for clinical opinion were subsequently reviewed by one of three lead specialists (two oncologists and a gastroenterologist) to identify any action required e.g. referral for serious incident (SI) investigation Non clinical review: The Trust s Cancer Programme Director provided clarification of CWTs guidance (v8.0) and reviewed all patients coded as potential data manipulation or for CWT expert opinion Multidisciplinary review: All cases identified for clinical review and also those coded as potential data manipulation were also assessed by a clinical review panel to provide objective assessment and inform the cancer action plan. The panel was made up of the Medical Director, Programme Director, Project Manager, Cancer Programme Director, Nursing Associate Director for Medicine and review lead specialists. Divisional Directors and senior clinicians were invited to attend. Following each panel meeting action was taken to address issues relating to the care of individual patients if required. 2.6 Analysis of cancer pathway (stage 5) Analysis of the data comprised: a) Quantitative analysis of the audit tool including: Descriptive analysis of age, gender, route of referral and other characteristics. Analysis of discrepancies between the case notes and CWT tool to identify accurate waiting times Analysis of cause of delays occurring on the pathway ( points of delay ) b) Qualitative thematic analysis of free text comments: Coded as non-clinical action i.e. actions needed to change administrative, technical, or clerical activity Coded as clinical action and assessed by the review teams lead specialists and Trusts multidisciplinary panel. Recorded on an issues log by auditors as they progressed c) Assessment of harm including review of patients referred for SI investigation and auditor, clinical panel and Assurance Panel assessments. 14

16 The data was analysed using Excel. 2.7 Assurance panel review of potential data manipulation The Assurance Panel, made up of all key stakeholders and chaired by NHS England, reviewed all cases coded as potential data manipulation against four questions to identify cases of data manipulation, if this had led to delay and subsequently harm, and hence required referral to the police. 2.8 Correlation with other studies Twelve patients (4%) were included in other audits cohorts; five in the Error Rate and seven in the Delayed Diagnosis audits 15

17 3. Results 3.1 Unverifiable data Seven key data items were audited for 283 patients resulting in 1,449 data entries/points. In seven cases notes were held at other Trusts and should not have been entered onto the CWT. Except for the purpose of describing the patients demographics and initial referral details, the results are therefore based on the 283 cases audited. When data was available on the CWT tool and also in the notes it is described as verifiable. Data was available on the CWT and/or in the notes In 1,449 data entries. On average 14% of data (200 of 1,449) was available only on the CWT which relates to 95 patients of whom 23 were on a single CHUFT pathway (3%) and 72 were on a shared pathway involving CHUFT and other Trusts (11%)(Table 2). Data Item No. of available No. of data items % unable to data items unable to verify verify Date Referral Received % First Seen Date % Waiting Time Adjustment (First Seen) % Decision to Treat Date % Treatment Start Date % Waiting Time Adjustment (Treatment) % Treatment Modality % Total data items 1, % Table 2: Summary of data entries reviewed 3.2 Rationale for including patients who did not meet inclusion criteria in analysis It was known from previous studies the CWT data included errors. If incorrect adjustments had been made to the CWT pathway this may have made the length of wait under 91 days erroneously. A total number of 18 patients were identified in the cohort who had had an adjustment that would have brought the length of wait to under 91 days. After the audit and analysis 25 patients had been treated in less than 91 days. These cases, although not meeting the inclusion criteria, were included in the analysis as auditors identified issues that needed to be addressed and as this was a look back exercise. Table 3 describes how the cohort fits with the inclusion criteria. Of the 25 cases that did not meet the inclusion criteria, 17 were treated before 91 days (before and after the 62 day target) and eight did not receive the first definitive treatment in that period. 16

18 Total No. of Cases in Cohort 290 Unable to Audit On CWT but not on PAS 7 % of Data Cohort 2% Audited Met Inclusion Criteria Treated after 91 days 258 % Who met inclusion criteria 91% Did not meet Inclusion Criteria Treated in time 10 Table 3: Distribution of cases by inclusion criteria 3.3 Cohort description Tumour site Treated between days 7 Not treated as recorded 8 Total not meeting inclusion 25 criteria % meeting inclusion criteria 9% Between April 2010 and Oct 2013, 4,461 patients were treated for cancer on the 62-day pathway in the 10 tumour sites of whom 290 (6.5%) waited over 91-days. Table 4 shows the total numbers and proportions of all 62-day patients and those who waited 91 days or more for treatment in the same period. It can be seen that urology and lower GI have a disproportionality high number of patients waiting over 91 days compared to all patients treated in that specialty on 62 day pathways over the study period. Figure 1 shows the number of patients waiting 91 days or more compared to the total number of 62 day treatments by tumour site. Tumour Site Total (62-Day Treatments) % of all 62 day treatments No. of 91-Day Long Waits % of 91 days long waits Urology Lower GI Upper GI Head and Neck Haematology Skin Lung Gynaecology Breast Sarcoma TOTAL % % Table 4: Proportion of 91-day waits and total 62-day pathways by tumour site 17

19 No. of Long Waits & Treatments per Tumour Site No. of Long Waits No. of Treatments Figure 1 Proportion of 91-day waits to total 62-day pathways Sources of referral Referrals to the 62-day pathway are made via three routes: Two week waits (2WW) (73%) referrals were made by GPs National screening programme - 34 (12%) referrals for Bowel, Breast, Bowel (lower gastrointestinal (GI)) and Cervical (Gynaecology) cancers Consultant upgrades - 7 (2%) referrals Age, mortality and gender of cohort In the cohort 61% (174 of 283) of patients were aged 65 and above, compared to 65% on Trust 62 day pathways overall and 63% nationally (Figure 2) 4 and the average age was 69 years. In May 2014 when the study was undertaken 17% of patients (47 of 283) were deceased. The majority of the patients were male (73%, 213 of 290), compared to 44% of patients treated on 62 day pathways in the same period due to the high proportion of cases in urology in the cohort (47%), who were mostly men (95%). 4 Figures from Cancer Research UK 18

20 25.0% Age Distribution 20.0% 15.0% 10.0% 5.0% 0.0% Figure 2: Age distribution of patients whose cancer pathway was over 91 days 19

21 4. Data Accuracy and Length of wait 4.1 Data accuracy There was a 9% inaccuracy (117 of 1,249 verifiable data items) in the overall number of data items in the cohort of patients waiting over 91 days compared to 10% inaccuracy found in the error rate report (Table 5). The highest number of incorrect entries was in date of decision to treat (32%, 37 of 117 data items) and treatment start date (25%, 29 of 117 data items) (Figure 3), higher than in the error rate study (27% and 15% incorrect entries respectively). One explanation may be erroneous recording of the date of the MDT (multi-disciplinary team) discussion rather than the date treatment was agreed by the patient. However, as a proportion of all data entries per field the highest proportion of errors was in waiting times adjustments 5. Number of data items % of incorrect entries Data Item Total Verified Incorrect data entries cf. the total number of incorrect entries in the cohort cf. number of verified entries in each field Decision to Treat Date % 16% Treatment Start Date % 11% Date Referral Received % 7% First Seen Date % 5% Treatment Modality % 5% Waiting Time % 44% Adjustment (Treatment) Waiting Time % 60% Adjustment (First Seen) Total data items % 9% Table 5: Summary of data entries reviewed for 283 cases 5 Waiting Time Adjustment (First Seen) This records the number of days that patients should be removed from the calculated waiting time for the two week wait period and potentially the 62 day period (if cancer is confirmed). Waiting Time Adjustment (Treatment) This records the number of days that should be removed from the calculated waiting time between the date of decision to treat and the treatment start date i.e. the number of days that a clock can be paused for a 31 or 62 day period if a reasonable offer of treatment in admitted care has been declined. 20

22 35% Proportion of incorrect date entries 30% 25% 20% 15% 10% 5% 0% Date of Decision to Treat Treatment Date Figure 3: Proportion of data inaccuracies on CWT data base by data item in each pathway when compared to data in the notes. 4.2 Accuracy in length of wait Referral Received Date Treatment Modality Date First Seen Waiting Time Adjustment (Treatment) Waiting Time Adjustment (First Seen) Given the number of data errors overall, it was important to determine how long in reality patients waited over 91 days. Auditors could calculate a difference ( variance ) between the dates in the CWT tool compared to the notes in 9% (54 of 631) of data points or episodes in three fields on the cancer waiting time pathway (referral received date, date first seen, and treatment start date). Table 6 gives the variance for each field. A negative number indicates the date recorded in the notes was before, and a positive number indicates that it was after, the date recorded in the CWT tool. Figure 4 shows the distribution of this variance. Figure 5 illustrates waiting times in the notes and the CWT by tumour site. In summary: When comparing dates in the CWT to those recorded in the notes the differences were mostly small: o In 54% of episodes (29 of 54 data points) the date recorded in the notes was before that recorded on the CWT Tool. o In 50% of episodes (27 of 54) the date recorded in the notes was within five days before or after the date recorded CWT Tool. Number with variance Referral received date (7%) 17 episodes of 233 data items Date first seen (5%) 11 episodes of 241 data items Treatment start date (10%) 26 episodes of 253 data items Total (7%) 54 episodes of 727 data items Average +2 days +2.9 days +1 day +2 days Range of variance to +118 (days) Table 6: Difference in time between data recorded on the CWT database and in the notes 21

23 Variance (Days) Variance in Date Items Variance (Days) -250 Case note Number Figure 4: Scatter plot of episodes of variance between dates recorded in notes and on CWT tool in patients on a cancer pathway over 91 days 4.3 Actual length of wait On average, patients waited 118 days wait from referral to treatment was using dates from the CWT tool and case notes. The average lengths of wait based on the CWT and notes were largely similar by tumour site except in skin (CWT average wait is longer than in the notes) and lung (CWT average wait is shorter than in the notes). Using data from the notes, patients waited longest in urology, gynaecology and lung. Nine patients in the urology tumour site waited an unacceptably long time to be treated (range days wait) Average wait length recorded in notes and on CWT (Referral to treatment) Data from Notes Data from CWT Tool Average Target Figure 5: Length of pathway using data from notes and CWT tool by specialty compared to average wait and 62 day target 4.4 Treatment modality Ten treatment modalities were recorded in the data sample and grouped into four treatment groups in line with CWT reporting formats. This indicated patients whose pathway was longer than 91 days were having surgery (52%,146 of 283), drugs treatments (21%, 59 of 283), radiotherapy treatments 22

24 (15%, 42 of 283), palliative treatments (11%, 32 of 283) and other treatments (0.4%, 1 of 283) (Figure 6). As in other fields that there was very little difference in dates recorded in the notes and on the CWT data base (Figure 7). 60% Treatment Groups 50% 40% 30% 20% 10% 0% Surgery Drug Treatments Radiotherapy Treatments Palliative Treatments Other Treatments All Treatment Declined Figure 6: Proportion of cases by treatment group with cancer pathways over 91 days 140 Average wait length by treatment group Data from Notes Data from CWT Tool Target Average 20 0 Palliative Treatment Surgery Radiotherapy Drug Treatment Treatment Figure 7: Average wait length by treatment group using data form notes and CWT tool 23

25 5. Final assessment by auditors Data was coded at the end of the audit into categories set by IMT (Table 7). Of 233 patients, 165 (71%) whose CWT Tool records could be audited in full had errors in at least one of their seven data fields, compared to 54% in the error rate audit. Code Definition % found (no. of cases) Primary audit No errors The record is found to be accurate and complete in all 29% (68 of 233) fields. Data with other Data unavailable as a result of treatment occurring at 17% (50 of 290) provider & not audited other hospital. Total data errors Including the categories below: 71% (165 of 233) by case Data entry errors Misinterpretation of the national guidance Operating process issue Potential data manipulation 1 Member of staff working outside the scope of their responsibility When CWT and other sources of information, including patient notes, match although the data has not been updated e.g. on another pathway, appointment brought forward, incorrect treatment entry When an incorrect entry appears to have been made as a result of a misunderstanding of the national CWT guidelines. A substantive error in a process or procedure, as opposed to the recording of that process or procedure. Where there is no valid explanation why CWT has been altered to meet national reporting standards and data does not reflect actual patient experience There is variance; and/or There is no valid reason Other sources give rise for concern e.g. complaints Clock stop on cancer pathway by any non-practicing clinician 16% (38 of 233) 6% (13 of 233) 45% (105 of 233 ) 3% (7 of 233 ) 1% (2 of 233) Table 7: IMT categorisation of data quality issues Note 1. This summary is based on auditor assessment only and therefore numbers are different after the clinical panel assessment where nine cases of potential data manipulation were reviewed. 24

26 6. Cause of delay A delay point is a point along a patient s pathway at which a delay occurred. The following section focuses on time, cause and agent of delay as assessed by the predominantly nurse auditors. There were 688 recorded points of delay, 689 recorded reasons for delay, and 687 points where agent of delay was recorded. Whether the delay was preventable was assessed based on the data available at the time. 6.1 Points of delay A total of 687 delay points occurred at four critical phases in the patients pathways (Table 8), the majority in the diagnostic phase (71% of delay points, 490/688) (Figure 8). Phase Description No % Diagnostic Between date first seen to decision to treat) % Treatment Between decision to treat and commencement of treatment % 1st Out Patient Between receipt of referral and first outpatient appointment 33 5% Tertiary referral Prior to receipt of tertiary referral from another hospital 20 3% Other/Unknown 43 6% Total no. of delay points identified 688 Table 8: Delay points identified in the cancer pathway 80% 70% 60% 50% 40% 30% 20% 10% 0% Major points of delay in cancer pathways Diagnostic Phase Treatment phase Other First OPA Phase Prior to Tertiary Referral being made Figure 8: Points of delay in the cancer pathways 6.2 Cause of delay Table 9 lists the main causes relating to 687 delay points (Figure 9). All causes of delay are listed in appendix 4 Cause Description Delay in booking An error or hold-up relating specifically to the booking 27% (185/687 appointments process National CWT Delay allowed for in the National Cancer Waits Guidance 18% (124/687 guidance Delayed/missing Diagnostic procedures that were carried out late or 13% (88/687 25

27 tests omitted e.g. an ultrasound, tissue biopsy, or endoscopy Patient choice Such as postponing treatment to take a holiday 14% (98/687 Patient unfit Patients temporarily too unfit to undergo a procedure or 6% or 42/687 treatment (distinct from having co-morbidities) i.e. from an infection or injury Clinical decision Decision imposed on the process by the responsible 4% or 26/687 clinician Inadequate capacity Situations when treatment or diagnostic facilities were 5% or 36/687 inadequate excluding staffing issues e.g. insufficient free slots on a theatre list Other reasons Unclassified 13% or 90/687 30% Reasons for Delay 25% 20% 15% 10% 5% 0% Figure 9: Reasons for delay in the cancer pathways measured in delay points 6.3 Auditors assessment of agent of delay Of all delay points recorded processes internal to CHUFT was responsible for more than half of all delay points (57%, 394 of 688). Other agents of delay included patients alone (20%, 135 of 688), other providers alone (14%, 93 of 688), or a combination of CHUFT Hospital, other providers and/or patients (9%, 66 of 688)(Table 10). CHUFT Other provider Patient Other CHUFT 57% (394) - - Other provider 5% (32) 13% (93) - Patient 2% (12) 1% (5) 135 (20%) 2% (17) Table 10. Agent of delay measured in delay points 26