North West Kidney Transplant Audit Project

North West Kidney Transplant Audit Project Final Project Report Supra District Audit Funded Apr 02 Oct 04 Audit Leads Dr Phil Dyer Mr Hany Riad Dr Faieza Qasim Hayley Moore Transplant Audit Co-ordinator Transplantation Laboratory Manchester Royal Infirmary Oxford Road Manchester M13 9WL Hayley.moore@cmmc.nhs.uk www.nwkta.org

Contents Page Executive Summary 3 Patient Involvement 4 Why Clinical Audit? 5 Renal and Pancreas Transplantation 6 Transplant Activity / Waiting Lists 7 Database Conversion and Expansion 9 NWKTA Website 10 Patient Pathway for Renal Transplantation 11 Audit against BTS Standards 12 Equity of Access to the transplant waiting list (pilot) 19 Immunosuppression Audit (pilot) 22 One year post transplant follow up audit 24 Cold Ischaemia Time Audit 25 Submitted Works 30 Acknowledgements 31 2

Executive Summary North West Kidney Transplant Audit (NWKTA) is a standards based programme that aims to continuously improve the quality of renal transplant patient care in the North West region through clinical audit. Since the group was established in April 2002 it has developed and expanded existing IT systems to respond to national guidelines and local requirements. During the last year: another year of data has been collected and analysed; new audits have been set up and piloted. North West Kidney Transplant Audit was funded for two years by the Supra- Audit District Group. (02/03 and 03/04). This report covers the work carried out during the 03/04 financial year. The audit has been led by a steering group and managed on a day to day basis by Hayley Moore the Audit Co-ordinator. Since the conclusion of Supra District Project funding a further extension of 5 months has been provided by the MRI Renal Transplant Unit. NWKTA is now working with the newly formed Renal Transplant Clinical Governance group to implement effective change. In the year to come it is proposed that routine data collection and analysis will continue. The piloted audits will be taken forward. With further years of cumulative data this audit process will continue to improve the quality of care across the region by highlighting deficiencies which can be corrected. These audits cover several datasets / audits required by National Institute of Clinical Excellence (NICE), British Transplant Society (BTS) and Renal National Service Framework (NSF). Transplantation costs an amount similar to dialysis in the 1 st post transplant year. However the cost is substantially decreased over subsequent years and quality of life is significantly improved. Hence any grafts whose life span is expanded through improvements in patient care make this audit worthwhile. 3

Patient Involvement It is clear that patient involvement is integral to the planning and provision of renal transplant services. The NSF for Renal Services sets out a vision of, a patient centred service. By involving patients in North West Kidney Transplant Audit we aim to offer a more patient-focused approach to the audit and clinical governance process. Patients offer a valuable insight into their experiences of: Living with renal failure Access to services and perceived / actual inequalities Perceived benefits and harms of treatment / care Their preferences for treatment / care How well or badly treatment and care are delivered Accessibility, efficiency and effectiveness of care delivery across different sectors (e.g. between primary and secondary care; between health and social services) The extent to which outcomes important to patients are achieved (including longer-term outcomes and quality-of-life issues) Patient information and support needs. Patient Representatives North West Kidney Transplant Audit has three patient representatives. Stephen Caddick, Shirley Wallwork and Jack Poulson all of whom have a functioning kidney transplant. North West Regional Kidney Patient s Association (NWRKPA) Hayley Moore (NWKTA Co-ordinator) has been co-opted onto the North West Regional Kidney Patient s Association committee. 4

Why clinical audit? Clinical Audit is a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change. Aspects of the structure, process, and outcomes of care are selected and systematically evaluated against explicit criteria. Where indicated, changes are implemented at an individual, team, or service level and further monitoring is used to confirm improvement in healthcare delivery. NICE 2002 Step 5: Implement Change Re-audit Step 2: Set a standard that illustrates best practice. Step 4: Analyse the data Compare performance against the standard. Step 1: Identify an Issue Step 3: Collect data As part of the modernisation agenda for the National Health Service clinical governance and clinical audit are an integral part of our clinical practice. The British Transplant Society has provided standards documents to illustrate the gold standards for performance in the field of transplantation. www.bts.org.uk 5

Renal and Pancreas Transplantation Renal and Pancreas Transplantation Services are provided by Manchester Royal Infirmary for a patient area / population of approx 4.25 million (former North Western Regional Health Authority). The area covered is organised as follows: Manchester East Sector and North Cheshire (Wythenshawe, Trafford, Macclesfield, Stockport and Tameside) Manchester West Sector (Wigan, Leigh, Bolton, Bury, Rochdale and Oldham) Lancashire and Cumbria (Preston, Blackpool, Barrow in Furness, Blackburn) A paediatric service is offered for both the above and Merseyside (Alder Hey) by the MRI Transplant Team at the Royal Manchester Childrens Hospital. Increasingly transplants are being carried out on patients from outside this area (extra contractual referrals). Manchester Royal Infirmary is part of the North of England Renal Transplant Sharing Alliance along with Leeds, Liverpool and Newcastle. The primary purpose of this Alliance of the transplant units is to manage the allocation of cadaveric renal transplants retrieved by these units when they are not allocated via the United Kingdom Transplant rules. Renal transplantation is the most frequent type of solid organ transplantation. Nationally, organs are allocated by UK Transplant to patients with a compatible ABO blood group and the least HLA mismatch. Allocation rules are available at www.uktransplant.org.uk In brief there is a three tier matching system: 1 No HLA -A -B -DR mismatch between donor and recipient. 2 A favourable match one mismatch at HLA A or B but none at DR. 3 All other HLA mismatch grades. A points scoring system is used if there are two or more equally matched recipients with the same priority. Organs are then allocated to the patient with highest number of points. The score for an individual patient is determined by several factors including: the patient's age the age difference between donor and recipient time on the waiting list (patients waiting longest are favoured) "sensitised" patients - whose bodies reject certain tissue types a "balance of exchange" points system which awards points to centres for each kidney they supply and deducts points for each organ received from outside its own area 6

Transplant Activity In the financial years 0203 and 0304 the Manchester Royal Infirmary Transplant Unit undertook the following activity: Transplant Type 02/03 03/04 Living donor 23 27 Deceased donor kidney alone 101 118 Simultaneous pancreas + kidney 6 6 Pancreas alone 4 7 Simultaneous heart + kidney 0 1 Total 134 159 7

Transplant Waiting Lists vs Transplants carried out North West Kidney Transplant Audit 700 600 500 400 300 200 100 0 93-94 94-95 95-96 96-97 97-98 98-99 99-00 00-01 01-02 02-03 03-04 Fig 1 Local Transplant Waiting List vs Local Transplants Fig 2 - National Transplant Waiting List vs National Transplants The number of patients waiting for a renal transplant is steadily increasing at both a local and national level. Nationally cadaveric renal transplants have fallen, the maintenance of overall activity has been possible due to an increase in the number of live donor transplants being carried out. 8

Database conversion and expansion An initial aim of the NWKTA Project was the development of the existing database held in the Transplantation Laboratory at the MRI. At the start of the project this held data on all transplants ever performed at Manchester Royal Infirmary. There was minimal clinical data recorded with the focus of the data recording survival of the transplant and the patient in relation to HLA matching. At this point clinical practice had already been influenced by audits from this database, which had shown that the matching of donors with recipients for HLA types conferred a significant advantage on transplant survival. In the first year of the project all existing records were updated in terms of graft outcome, patient outcome and centre of follow up. To do this links were established between NWKTA and its external dialysis centres (Royal Preston Hospital, Hope Hospital and Royal Manchester Children s Hospital). As a quality exercise we liaised with UK Transplant to carry out a comparison between the data held locally on patients transplanted at Manchester Royal Infirmary and that held nationally. The results and differences highlighted were presented to the North of England Renal Transplant Sharing Alliance meeting in September 2003. At the end of the 02/03 we converted to a newly built Access database. Our data had previously been stored in a statistical package (SPSS). SPSS is still used for the statistical analysis of data. During the last year the database has been radically expanded to accommodate the piloting and carrying out of new audits. Expansion of the dataset was required for: Cold Ischaemia Time Audit Patient Follow Up One Year Post Transplant Immunosuppression Audit (pilot) Equity of Access to the transplant waiting list (pilot) The collection of such data allows us to meet in-house and Alliance audit requirements easily as well as providing a useful resource for monitoring and highlighting any significant clinical trends that impact on patient outcome. 9

NWKTA Website The Project has its own website www.nwkta.org The website contains useful information including activity, current audits and past presentations. Fig 1: Home page of www.nwkta.org 10

Patient Pathway to Renal Transplantation North West Kidney Transplant Audit GP referral Other specialty referral Unplanned emergency Renal Assessment Pre-dialysis clinic Renal Replacement Therapy Tpx Work Up Failing Pre-emptive Tpx Transplant Transplant Waiting List 11

Audit against BTS Standards Standards taken from the 2003 British Transplant Society document, Standards for solid organ transplantation in the United Kingdom, BTS Standard 2.2.1.1 There must be demonstratable equity of access of donor organs irrespective of gender, race or district of residence. Current Status: Completed Manchester Royal Infirmary is part of all the required sharing schemes laid down both locally, regionally and nationally (UK Transplant). These schemes were designed to ensure equality of access to donor organs once the patient is placed on the waiting list. BTS Standard 2.2.1.7 The transplanting surgeon.. must satisfy himself that he has all the known facts about the donor and that the organ is safe to transplant. Current Status: Completed This proved to be a difficult standard to audit. Currently the transplanting surgeon reviews the notes relating to the donor and checks that the organ is suitable prior to transplant. It was concluded in house that this was not an appropriate standard to audit due to difficulties in collecting appropriate information. BTS Standard 2.3 Every local transplant service should agree criteria with its commissioners for acceptance of patients with particular conditions onto the waiting list. Current Status: Ongoing Manchester Royal Infirmary, Hope Hospital and Royal Preston Hospital have a transplant work up and screening protocol, this aims to minimise the likelihood of peri-operative deaths and ensures all required information is available at the time of surgery. This standard links with the need for an audit of equity of access to the transplant waiting list. We have demonstrated that the transplant unit provides equity of access to donor organs by following the national, sharing alliance and local protocols. However by having separate work up and screening protocols at the individual renal centres there is a risk that there will be variation as to which patients will be considered suitable for transplantation. Recommendations: To carry out an equity of access to transplant waiting list audit. See Proposed Pilot Study of Equity of Access to the Transplant Waiting List on page 20 12

BTS Standard 2.5 All centres must participate in the sharing schemes, which are designed to produce the best possible outcome for every donated organ which is available for transplant. Status: Completed Manchester Royal Infirmary is part of all the required sharing schemes laid down both locally, regionally (northern/eastern/western sharing alliances) and nationally (UK Transplant). These schemes were designed to ensure equality of access to donor organs once the patient is placed on the waiting list. BTS Standard 4.2.1 At least 40% of dialysis patients in most units will be suitable for transplantation. Patients who are placed on the waiting list prior to commencing a maintenance dialysis programme should only receive a well-matched kidney. Cardio-vascular disease, diabetes, previous malignant disease and other co-morbidities should be assessed and recorded. Assessments should be repeated annually while on the waiting list. Not more than 2% of non-sensitised patients should have to wait more than 5 years for a transplant. Status: Ongoing Audit of these standards is incorporated in the Proposed Pilot Study of Equity of Access to the Transplant Waiting List on page 20 BTS Standard 4.2.3 The kidney cold storage time whenever possible be kept below 24 hours. Current Status: Ongoing audit 118 deceased donor kidney alone transplants were carried out in the 0304 financial year. Of these CIT data was collected on all transplants: Frequency Percent < 24 hours 90 76.3 >=24 hours 28 23.7 Total 118 100.0 In 2002 out of all 115 kidney alone transplants carried out (including living and paediatric transplants) 87 transplants met the standard 73.1%, 28 transplants did not 13

meet the standard 23.5% and 4 transplants had an unknown cold storage time 3.4%. Hence there is a 3.2% improvement in the number of kidneys meeting this standard. A significant number of our transplants are still not meeting this standard. A cold storage time audit has been carried out prospectively from the start of 2003. This records key time periods and reasons behind delays in the process. See Cold Ischaemia Time Audit on page 26. BTS Standard 4.2.4 Each unit should aim to transplant at least 26 patients per million population per year with cadaver kidneys. Current Status: Completed Manchester Royal Infirmary serves a population of approximately 4.25 million. To achieve the standard for one year 111 people should receive a cadaveric kidney transplant. In the 0304 financial year 125 patients received a cadaveric renal transplant (value includes those receiving a simultaneous pancreas and kidney transplant and those receiving a simultaneous heart and kidney). The Renal Transplant Unit met the standard for the 0304 financial year. BTS Standard 4.2.5 All living donors should be followed up on a long-term basis following transplantation. Current Status: Completed All living donors are followed up on a long term basis. This is a requirement from UK Transplant. A new database system is being created to help facilitate accurate inhouse records. BTS Standard 4.3.1 Renal transplant units should be capable of achieving 75 transplants per annum. Current Status: Completed In the fiscal year 0203 Manchester Royal Infirmary carried out 152 renal transplants. (including simultaneous pancreas and kidney and simultaneous heart and kidney, excluding pancreas after kidney) Conclusion: The transplant unit performed well above this standard. 14

BTS Standard 4.5.1 45% of recipients should receive a favourably matched kidney. Current Status: Completed 100 / 010 / 110 52.5% 0 DR 13.6% 000 17.8% 1 DR 12.7% Fig 3: HLA-mm groups of transplants carried out in 0304 In 0304 70.3% of all recipients receiving a renal alone transplant, had a favourably matched kidney. On the chart above that is those with 000 or 100 / 010 / 110 (shown in green) Conclusion: Manchester Royal Infirmary performs considerably better than that required by the standard. This suggests that as all centres must follow the national allocation procedures that this standard needs to be raised to a higher level. 15

BTS Standard 4.7.2 Patient survivals should exceed 90% at one year, 80% at 5 years and 60% at ten years. Current Status: Completed 100 90 80 70 60 50 1 y 3 y 40 5 y 30 20 10 0 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 BTS Standard 4.7.3 Graft survivals should exceed 80% at one year, 60% at 5 years and 45% at ten years. 100 90 80 70 60 50 1 y 3 y 40 5 y 30 20 10 0 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 16

Standards taken from the British Transplant Society document, UK guidelines for living donor transplantation. Published by BTS in 2000. BTS Standard 5.2 The major peri-operative complication rate for donor nephrectomy is approximately 2% BTS Standard 20.2 Donors should be followed up to facilitate the collection of data on long-term morbidity and mortality. Current Status: Ongoing Currently there is no database system for the follow up of living donors. Paper records are kept and returns are made to UK Transplant. We are currently piloting a new electronic system for the effective monitoring of living donors. This will include all potential donors and any work up and tissue typing that they receive. Once transplanted audit data will be collected at 6 weeks then yearly post transplant. Data collected will include complications and long term morbidity and mortality. BTS Standard 2.1 There is considerable scope for increasing living donor transplant activity and a target in excess of 10pmp pa seems reasonable In 2000 the average in Britain was 4pmp pa. Current Status: Completed In the 0304 financial year 27 living donor transplants were undertaken which is the equivalent of 6.3pmp. This is an increase on the 0203 financial year when 23 transplants were carried out (5.4pmp). Manchester Royal Infirmary has seen a dramatic rise in the number of living transplants carried out over the last three years due to the funding by UK Transplant of a Live Related Transplant Co-ordinator as part of their nationwide initiative to increase living donation rates. BTS Standard 7.5 Evaluation of a living donor should be undertaken according to an agreed protocol. Current Status: Completed Prospective living donors are worked up according to an agreed protocol. 17

BTS Standard 21.1 Recipient survival should be >95% at one year and 90% at five years. Graft survival should be >90% at one year and >80% at five years. Recipient Survival 100 90 80 70 60 50 1 y 3 y 40 5 y 30 20 10 0 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 Graft Survival 100 90 80 70 60 50 1 y 3 y 40 5 y 30 20 10 0 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 Survivals are mainly within target since 2000 when the standard was set. It must be noted that due to the very small number of cases in each year (1994-2002 had between 10 and a maximum of 18 cases each year) that one failure or death has a strong impact on the survival rates for that year. 18

Proposed Pilot Study of Equity of Access to the Transplant Waiting List Renal transplantation is the most successful and cost effective treatment for suitable patients with established renal failure (ERF). In the United Kingdom demand for cadaveric kidneys far outweighs their availability. Cadaveric kidneys are a valuable resource that should be used optimally but it is also vital that equity of access to the transplant waiting list is achieved. Not all patients with ERF will be medically suitable for transplantation. However, selection criteria for being placed onto the transplant waiting list, varies widely across the UK. Renal Replacement Therapy (RRT) is limited in North West England particularly for haemodialysis but there is a strong transplant program. There is a direct need for research to ensure we are offering our patients an effective and equitable service for access to the transplant waiting list. This project aims to both review service provision related to equity of access to the transplant waiting list in the former North Western Regional Health Authority. We aim to process map how patients are placed onto the renal transplant waiting list to identify how the existing system works. A cohort study of all new patients entering RRT will be carried out. These patients will be followed to placement on the renal transplant waiting list, transplantation, death or to the end of the study. Patients who are placed onto the waiting list before starting RRT, have a pre-emptive transplant or have missing data will be excluded from the study. We have gained the full support of clinicians at all centres and will set up a working group to ensure that the findings of the study are implemented. We then aim to demonstrate that the changes implemented have made improvements to the service. Hypothesis Access to the North West Regional deceased donor kidney waiting list is inequitable and is influenced by both controllable and uncontrollable factors. Aims We aim to carry out pilot research on a prospective and retrospective basis over six months to review access to the renal transplant waiting list in the former North Western RHA. To identify inequalities and the factors which cause such inequalities. To support clinical colleagues to act to redress inequalities were this is achievable. This research project aims to achieve the following: Review the transplant waiting list, Process map the patient pathway, Predictive Testing, 6 month Pilot Study Review transplant waiting list At the start of 676 patients were on the transplant waiting list in the North West of England. Of these 163 patients were suspended which could either be currently unavailable or medically unfit. We need to ask the following questions: Who is on the waiting list? Who didn t get on the transplant waiting list? How is fitness for transplant defined? Are all centres implementing UK Transplant guidelines? Plan of investigation From clinical databases situated at the Royal Preston Hospital we will identify a cohort of adult patients starting renal replacement therapy between two time periods. 19

This site has been chosen because of the efficient local data collection which is recorded electronically. These patients will be followed to the following censor points: placement on the renal transplant waiting list, transplantation, death, end of the study. Patients who are placed onto the waiting list before starting RRT, have a pre-emptive transplant or have missing data will be excluded from the study. Data will be collected on the following variables: Age Gender Social Deprivation (Carstair's Index) Primary Renal Disease Renal / Renal Transplant Unit Postcode (Geography) Type of Renal Replacement Therapy (RRT) Length of time on RRT Ethnicity ABO Blood Group matchability defined by UK T Co-morbidity This data will be collected in an electronic format at the individual units and stored in an access database. This will be exported into SPSS for analysis. Statistic techniques include 2x2 tables, chi square tests, survival analysis and odds ratio calculations. Univariate and multivariate cox proportional hazards regression analysis will be used to investigate variables associated with the chance of being placed on the renal transplant waiting list and hence undergoing a transplant. This project has been developed in collaboration with Prof Peter Diggle (Medical Statistics) at the University of Lancaster and with Prof Gary McFarlane (Epidemiology) at Manchester University. From them we will have academic advice and guidance on the project. Hayley Moore would carry out the work on a day to day basis under the supervision of Philip Dyer. This issue of equity of access to transplant listing was raised at the NWKTA Project Partners Meeting in January 2004. There was universal support for a novel research project to look at equity of access to the transplant waiting list. Following this we wrote to all the consultants of the three units this concerns: Manchester Royal Infirmary, Hope Hospital and Royal Preston Hospital. All three units have signed up in support of this project going ahead. We will set up a multi-disciplinary working group to facilitate the implementation of change and to create a culture of ownership, responsibility and accountability. Outcomes This work is of high clinical importance. The Renal National Service Framework standard five: transplantation aims to optimise access to and the outcome of a renal transplant for all those who could benefit. By carrying out this research and process mapping the patient pathway we will be able to understand what is happening within the service now. We can compare this with the ideal service we wish to provide. By working as a multi-disciplinary team with patient involvement we will implement 20

change to ensure that we are providing a fair and equitable service to all those who would benefit from it. Hence it will enable effective entry to and management on the deceased donor transplant waiting list. References 1. http://www.uktransplant.org.uk/statistics/yearly_statistics/yearly_kidney_statist ics.htm 2. McMillan MA, Briggs JD Survey of selection for cadaveric renal transplantation in the United Kingdom. Nephrol Dial Transplant 1995;10:855-8 3. Rudge CJ, Fuggle SV, Burbridge KM Geographic disparities in access to organ transplantation in the United Kingdom. Transplantation 2003; Vol 76 No.9: 1395-8 4. Oniscu GC, Schalkwijk AAH, Johnson RJ, Brown H, Forsythe JLR Equity of access to renal transplant waiting list and renal transplantation in Scotland: Cohort Study. BMJ; vol 327:29/11/2003 5. EBPG Expert Group on Renal Transplantation- European Best Practice Guidelines For Renal Transplantation. Nephrol Dial Transplant 2000; Vol 15 Supplement 7. 6. http://www.bts.org.uk/forms/waitinglistcriteria.doc 7. The Renal Association Treatment of adults and children with renal failure, standards and audit measures. 3 rd edition; August 2002 8. British Transplantation Society Standards for solid organ transplantation on the United Kingdom. 2 nd edition; July 2003 21

Audit of Immunosuppression at Manchester Royal Infirmary (Proposed 04/05) Introduction Renal transplantation is the treatment of choice for patients with Established Renal Failure (ERF). The success of transplantation has been made possible with the introduction of immunosuppressive therapy. The number of drugs available has increased steadily over the last forty years. These drugs used either alone or in combination make it possible to prevent rejection. The tailoring of immunosuppression for the individual involves striking a delicate balance between preventing rejection and the potential side effects associated with the drugs. Until recently no guidelines existed that gave specific recommendations on immunosuppressive therapy. Each unit had it s own written protocol. Manchester Royal infirmary is currently a cyclosporin monotherapy centre. The National Institute of Clinical Excellence (NICE) has released its Final Appraisal Determination on Immunosuppressive therapy for renal transplantation (Jan 2004). This provides recommendations for the use of immunosuppression in renal transplantation. This has instigated the need to review Manchester Royal Infirmary s immunosuppressive protocol. This is currently being reworked, once the unit has achieved a change in protocol, this audit will be able to measure that protocol against actual practice. From this we can conclude that there is a need to audit the immunosuppressive regimens here at MRI which is a requirement of the NICE Guidance. The collection of such data would aid in the effective audit of our new protocol and provide an easy and effective way to monitor each patient s treatment. A working group will be created to lead the audit and we invite any interested parties to take part. Initial aims and objectives Initially we propose a three month pilot audit. This will allow us to highlight the resources required and any problem areas. This will incorporate the following: To compile a patient pathway for immunosuppression To agree variables and criteria for effective data collection To set up a suitable database (Access) To collect data on new transplant patients for a three month period To assess the need for a project website Outcome The projected outcome is to lead to a full scale audit of immunosuppressive therapy in patients transplanted by MRI. Clinical Importance Such an audit will enable effective monitoring and management of the immunosuppressive regimens of the individual patient. The data will allow effective audit of the NICE guidelines, BTS and Renal Association Standards. Database Structure and Data Collection 22

A system was required to store the extra data that would be generated from this project. It was decided build the data into the new access database system used by the North West Kidney Transplant Audit Project. By doing this each patients immunosuppression details would be automatically linked up to all the other data electronically held about them. Hence other factors such as clinical complications, rejection and delayed graft function can be looked at alongside immunosuppressive therapy. Data will be collected on a series of forms immediately after transplant, 3 months, 6 months and 12 months. The forms are automatically generated when required using a mail merging system, which pre-fills in core patient identifiers to reduce the likelihood of error. Once completed, will be added to the database via a duplicate electronic form. The Pilot Audit The variables to be collected are to be distributed amongst clinicians to gain feedback. After feedback is gained and the variables reviewed data will be collected retrospectively for the period April-August 2004. The full audit will start from September 2004. 23

One year post transplant follow up audit North West Kidney Transplant Audit Data has routinely been collected in the past to follow recipients both in-house and to fulfil alliance requirements in the first year post transplant. This has been achieved through the use of an, audit book. We carried out this audit for the 0304 financial year using the newly developed access database and new data collection forms. The following information was collected: No. of transplants carried out Graft and patient survival in the first year Number of transplant (ie 1 st / 4 th etc) Recipient Age Number of diabetic recipients Initial immunosuppression Rejection Episodes Treatment with ATG Number of biopsies performed Results of biopsies performed Incidence of non-functioning transplants Incidence of Delayed Graft Function Early surgical complications (during 1 st inpatient stay) Early infectious complications (during 1 st inpatient stay) Late infectious complications (during 1 st year) Late medical complications (during 1 st year) The summary of this data for both this centre and the Leeds, Liverpool and Newcastle transplant centres can be found at: http://www.ktnoe.org.uk/activity.htm 24

Cold Ischaemia Time Audit 18 month Review Evidence Base North West Kidney Transplant Audit National National analyses have only recently been carried out by the UK Transplant Kidney and Pancreas Advisory group. This was due to there being incomplete recording of CIT data before 2000. Analysis of 2348 first cadaveric heart beating kidneys carried out between January 2000 and June 2002 showed there to be a highly detrimental effect of long CIT on one year transplant survival. In conclusion highlighting the importance of minimising CIT to improve post-transplant outcome. Manchester Experience All deceased donor kidney alone transplants carried out from 1990 to end 2003 1.0.9.8.7.6 Cum Survival.5.4.3 0 2 4 6 8 10 12 14 CIT > 22 CIT > 22-censored CIT <=22 CIT <=22-censored Dataset and methods This set contains 145 records Deceased heart beating donor Kidney Alone Adult Recipient Jan 2003 June 2004 (18 months) 25

Variable Min Max Missing Present Donor x-clamp 02/01/03 29/06/04 2 143 Time UK T offered 03/01/03 13/04/04 5 140 Surgeon Nephrologist Time Accepted 03/01/03 13/04/04 4 141 Arrival Time 02/01/03 09/06/04 47 98 Xmatch Result 03/01/03 15/06/04 2 143 Anaesthesia Start 03/01/03 29/06/04 10 135 Incision Time 03/01/03 29/06/04 10 135 Surgeon Operating Out of Ice Time 03/01/03 29/06/04 12 133 Reperfusion Time 03/01/03 29/06/04 12 133 DGF 0 145 3 Month Creatinine 13 132 CIT (decimal hs) 0 145 65 cases were 19 hours or less and 80 cases were 19 hours or more. X clamp UK T offer accepted arrived xmatch anaesthetic incision Out ice reperfusion T offer T accept T arrive T xm T theatre T cut T op Tperf Calculated Variable Range (decimal h) Present Toffer 0.00-17.60 138 Taccept 0.00 2.48 140 Tarrive 0.07 8.90 44 Txm 2.50 8.25 46 Ttheatre 0.23 20.43 133 Tcut 0.28 1.58 134 Top 0.17 2.82 131 Tperf 0.00 1.17 133 The data was collected by Dawn Lee a transplant co-ordinator. Some missing data on time of offer and time of acceptance was provided by UK Transplant. The dataset was interrogated using SPSS software. 26

35 30 25 20 15 10 5 19h and under 0 Local Import Alliance over 19h Figure 1: Bar chart to show number of cases by kidney origin clustered by CIT group 30 20 10 0 37.5 35.0 32.5 30.0 27.5 25.0 22.5 20.0 17.5 15.0 12.5 10.0 Std. Dev = 6.32 Mean = 20.5 N = 145.00 Cold Ischaemia Time Figure 2: Histogram of Total Cold Ischaemia Time with distribution curve 27

20 10 0.0 2.0 4.0 6.0 8.0 10.0 12.0 14.0 16.0 18.0 20.0 Std. Dev = 4.32 Mean = 5.6 0 N = 133.00 Time to Theatre Figure 3: Histogram of time to theatre with distribution curve 30 25 20 130 15 10 Time to Theatre 5 0 98 99 N = 59 19h and under 74 Over 19h Figure 4: Box Plot of Time to Theatre categorised by CIT Pearson Correlation of Time to theatre and CIT Time to theatre had a very wide range of values (0.23 20.43 hours), we looked at the relationship between time to theatre and total Cold Ischaemia Time. 28

30 20 10 Time to theatre 0 0 10 20 30 40 Total Cold Ischaemia Time Figure 6: Scatter plot of CIT versus Time to Theatre The correlation coefficient is +0.53 and its p value is <0.001 hence there is a linear correlation between time to theatre and CIT. Conclusions Total CS No. 3/12 Cr 3/12 graft loss DGF (%) (h) Patients (Mean) (%) <20 85 157 4.5 16.5 a 20-24 22 149 4.5 13.6 b >24 38 158 7.9 23.7 c 145 not sig not sig a+b vs c p =0.28 Data was split into three six month periods to compare and evaluate any effects the audit may have on CS time. There was an increase in the proportion of transplants done within 19 hours over the period of the audit from 21 to 28 transplants (+3%). The only time interval which correlated with prolonged CS was the interval of waiting for access to theatre following reporting of the cross match result (linear association, R=0.6). This audit confirms that prolonged CS increases the incidence of delayed graft function and the incidence of 3 month graft loss. The primary cause of prolonged CS is the interval of waiting for access to theatre following reporting of the cross match result. This is a modifiable factor. The number of kidneys transplanted below the median CS increased during the audit. This audit will continue indefinitely and long term outcome will be monitored to establish the effect of prolonged CS. 29

NWKTA Project Submitted Works and Presentations see www.nwkta.org "A renal transplant & renal related surgery BTS Standards audit project" Poster presented at British Transplant Society Conference April 2002 3000 Transplants at one UK Centre Poster presented at British Transplant Society Conference April 2003 Audit of Transplant Unit 1993 to 2002, Presented at Hope Hospital and Manchester Royal Infirmary (see appendix) 3000 Renal Transplants at Manchester Royal Infirmary, Presented at North of England Renal Transplant Sharing Alliance Meeting March 2003 NWKTA Project Aims and Objectives Presented as invited speakers at NW Kidney Club Meeting 2 nd July 2003 North West Kidney Transplant Audit Project Audit against Standards Poster at Renal Association Conference October 2003 Development of an evidence based research tool from three thousand consecutive renal transplants in the UK s largest single centre Poster at CMMC Research and Development Exhibition September 2003, short listed for trust award. How well does data from local kidney transplant records and the National Transplant Database correspond? Presented at North of England Renal Transplant Sharing Alliance Meeting March 2004 The causes and effects of prolonged kidney cold storage time a single centre prospective audit. Submitted abstract for British Renal Society Conference 2005 and British Transplant Society Conference 2005 ( www.bts2005.org.uk ) 30

Acknowledgements We would like to thank the Supra-District Audit Group of Greater Manchester for providing funding and support to this project. We are grateful to: The Renal Transplant Unit Team at Manchester Royal Infirmary The Referring Dialysis Unit Staff at MRI, RPH, Hope and RMCH who have provided us with details of follow up of our transplant patients. Mr Jack Poulson, Steve Caddick and Shirley Wallwork our patient representatives UK Transplant for providing details from the national database for quality review. Rachel Johnson Principal Statistician at UK Transplant for advice and support 31