Nephrology and Transplant Directorate Cardiff Transplant Unit Continuous Improvement Plan In response to Incident Reference

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1 This is a live document and subject to regular and ongoing review and updates. Please refer to version control and date. Recommendation Action Required Individuals Timescale Progress and Barriers Status Responsible -Marginal organs accepted will be discussed with a second senior clinician. A list of cases considered marginal needs to be agreed. All consultants Protocol active from Protocol agreed (appendix 1) Complete 1. The multi-disciplinary Team is a well-developed concept in the care of transplant patients. Marginal decisions, such as those in these tragic cases, are very difficult and shared expertise is valuable. Organs accepted for transplantation should be discussed with a second senior clinician with the appropriate expertise. -With regards to organ offers from donors with brain tumours and other malignancies, the case will be discussed with a second senior, experienced clinician before accepting the organs. All these discussions to be accurately and contemporaneously documented in patients notes. -The current moratorium on accepting organs from meningoencephalitis will continue until a new algorithm is agreed. MS Protocol active from Protocol agreed (appendix 2) Complete -Develop an algorithm for considering organ offers from donors with meningoencephalitis. Version: 07 Page 1 of th October 2014

2 - A formal discussion of performed transplants for the previous month will be scheduled on a monthly basis. MS Commenced 14 th August Attendance at the meeting will be mandatory and needs to be factored into job planning. Progressing as planned - Presentations and documentation to be transferred to the S-Drive MS Commenced 14 th August 2014 Progressing as planned 2. Clinicians considering organ offers should have the ability to access information on the NHSBT Electronic Offering System at any time. - All consultants will access and review the EOS website for cases that are being accepted. - Reliance will not be entirely on the verbal information given by the on call recipient nurse team. All consultants All consultants With immediate effect With immediate effect -All Consultants have access to EOS whilst on call. -Surgeon will sign to state they have seen the information on EOS before implanting Completed Completed 3. If organs are to be allocated outside the national matching run sequence then the Cardiff Unit should draw up, and adhere to, written guidelines for the - Undertake monthly audits of use of EOS for accepted organs -Review and revise the existing protocol to formally include both DCDs and fasttrack offers. CW SG Monthly November Audits will begin in September - Second draft of protocol is being reviewed. First audit on target to take place in September Partially completed Version: 07 Page 2 of th October 2014

3 allocation of offers such as fast track offers and kidneys donated after circulatory death. 4. The Cardiff Kidney Transplant Patient Information Booklet should be made available to all patients on the waiting list for a transplant so they may be aware of the risks inherent in using organs from deceased organ donors. - A copy of the booklet will be sent to all patients on the transplant list including those suspended. To be sent with covering letter. -A copy of the booklet will be sent to the Consultant Nephrologists, SpRs, Staff Grade and other staff who are not familiar with it, informing them of this; the rationale being, pre- and dialysis patients are likely to discuss the booklet with their current Nephrologist. DC AA By 31 st May 2014 Immediately Completed Completed Completed Completed -A copy of the booklet will also be given to the Chronic Kidney Disease Nurse team, for their information. DC Immediately Completed Completed Version: 07 Page 3 of th October 2014

4 5. The consent process should follow the NHSBT / BTS guidelines. In particular: - The reaffirmation of consent on the day of transplant should detail any specific donor risks, such as those associated with donor infection, donor cancer, and donor risk behaviour, as well as organ function. - Consideration should be given to developing a specific consent form for transplants that explicitly states the risks associated with transplantation. - Explanations of any discussion regarding the risks associated with an organ should be clearly documented in the patient s notes, dated and timed. Ideally the next of kin should be party to such discussions and their presence documented. -Review and revise the consent process for patients undergoing kidney transplantation (including the documentation of that consent) in line with the guidelines from NHSBT/BTS - Audit the documentation of consent for each consultant surgeon prior to the SI Initial 5 sets of consent processes to be audited retrospectively 5 sets of consent processes to be audited prospectively Agree the auditing of all Tx surgeons MS September Revised consent pathway has been agreed and is in place (appendix 3) -A new consent to inclusion on the transplant list (appendix 4) has been active since September The new consent form has been converted into Welsh and is being made into the triplicate format (English/Welsh/English) as per the All Wales requirements -A Model Consent form has been devised and is available for reference on the transplant ward and on the S drive Complete SG 25 th July -Completed Completed Version: 07 Page 4 of th October 2014

5 consenting processes 6. The hospital is encouraged to review its procedures for communicating with families in the face of such events as occurred in this case. -Develop a robust system to ensure that everyone involved in the management of these cases is informed of the developments, in order to avoid delivery of correspondence or supplies post death FB Immediately -Timeliness of death notifications to the Directorate Systems are in place, but will be reviewed. -Regarding communication concerns between the UHB and the families, Being Open training will be undertaken by medical and nursing staff. MR To be determined -Correspondence to the specific families of the patients from Nephrology & Transplant and Critical Care is to be reviewed by the Specialist Services Clinical Board Nurse in partnership with Ruth Walker and Graham Shortland before it is communicated. CF Immediately Systems in place -Critical Care to review the bereavement follow up service and communication of this to families GSc Immediately -CC bereavement service suspended subject to review. Letter sent to both families Further review of service to be completed Version: 07 Page 5 of th October 2014

6 -The Nurse Director has instructed the Patient Safety Manager to be the lead contact for both families. Frequency of contact and such like is to be agreed. MR Immediately -Both families aware and contact is being made at their request or when appropriate to keep them updated. In place -A communication strategy with families needs to be identified when any serious incident takes place RW May 2014 Completed -A meeting with both families with the Executive Nurse Director and Executive Medical Director following receipt of the external review report is required RW May RW & GS have attended meetings with both families. Completed -The Being Open policy will be reviewed and key principles regarding patient / family contact will be referenced. Being Open principles and role clarity for lead contacts will also be reflected in associated policies, namely the incident reporting policy. These matters will be consulted via the Assistant Director of Patient Safety and Quality; Assistant Director of Patient Experience MR December 2014 To be progressed via electronic incident reporting upgrade mechanisms. Version: 07 Page 6 of th October 2014

7 and Concerns Manager. The policy will reflect and embed key elements of the Putting Things Right regulations including proportionality with regard to the level of grading of the concern. Nephrology and Transplant Directorate -An investigation toolkit will be launched that will include reference to Being Open principles. CE July 2014 Underway -Opportunities to offer Being Open training will be explored. MR July 2014 Progressing as planned -Principles of Being Open will be included in training undertaken by the Patient Safety Team and Concerns Team where appropriate. CE In place In place 7. The hospital is encouraged to review the procedures for admitting patients who have been asked to re-attend without having to endure a protracted delay through the emergency department processes. -CTU ward nursing staff to be informed that when contacted, to ensure that the Telephone Advice Book is completed whenever patients telephone for advice. This is to ensure patients are admitted directly to the ward when the bed is available and also that the NL Immediate In place Version: 07 Page 7 of th October 2014

8 Transplant Registrar is contacted for further advice. The Ward Sister will bring this up at the Safety Briefing (twice daily). Nephrology and Transplant Directorate -The Directorate will confirm admission protocols to both wards with a focus on ensuring we are appropriately managing the primary medical need for admission in conjunction with colleagues from EU. NL End July -Need to discuss with representatives from the emergency unit re: patient flow from EU Progressing as planned -CTU nurses and Registrars to be informed that patients can be booked into hot transplant clinics Monday-Friday where patients can be seen immediately if admission is not required. NL Immediate Complete -The Telephone Advice Book, in conjunction with the patient clinical record and VitalData to be audited. DC By 31 st May Ongoing audits will ensure this process is continually monitored. 1 st audit completed. Further audits to be arranged. -Telephone log book to be completed on all occasions MS Commenced 6 th August All junior doctors will require UHB addresses Complete 8. Given the paucity of The case will be written for To be determined To be -Needs further discussion Version: 07 Page 8 of th October 2014

9 publications about donor transmitted encephalitis in the literature, the unit should write up these two sad cases such that the transplant community has a chance to learn from the events. publication in due course. Clinical Board in partnership with the Nurse Director to closely communicate with families in relation to publications. CF/RW determined before commencing Version: 07 Page 9 of th October 2014

10 Identified staff CF Carys Fox (Clinical Board Nurse) AA Argiris Asderakis (Consultant Transplant Surgeon) RC Rafael Chavez (Consultant Transplant Surgeon) MS Mike Stephens (Consultant Transplant Surgeon) NL Noreen Lewis (Lead Nurse) CW Catherine Wood (Directorate Manager) BH Brendan Healy (Consultant Microbiologist) DC Dawn Chapman (Transplant Specialist Nurse) AI Adel Ilham (Consultant Transplant Surgeon) GSc Gareth Scholey (Consultant Intensivist) GS Graham Shortland (Medical Director) RW Ruth Walker (Nurse Director) AH Angela Hughes (Concerns Manager) MR Maria Roberts (Patient Safety Manager) CE Carol Evans (Assistant Director of Patient Safety) FB Fiona Baldwin (Acting Directorate Manager at the time of incident) SG Sian Griffin (Consultant Transplant Nephrologist) JB Julia Barrell (Mental Capacity Act Manager) NM Nav Masani (Clinical Board Director) CBNs All Clinical Board Nurses Version: 07 Page 10 of th October 2014

11 Appendix 1 PROTOCOL FOR TRANSPLANT ORGAN OFFERS WHERE THERE IS AN INCREASED RISK OF DONOR DISEASE TRANSMISSION Cardiff Transplant Unit Version 1 Author Michael Stephens Agreed Effective Review date Background Donor-derived disease transmission (defined as any disease present in the organ donor that is transmitted to at least one of the recipients) is a possible and not infrequent occurrence in solid organ transplantation. Donors are screened for a finite number of pathogens and for some diseases such as cytomegalovirus (CMV) disease transmission is common, in which case the focus is on prophylaxis and pre-emptive monitoring to minimise the impact of disease transmission. Unexpected disease transmission can also occur, and there are well documented cases of such infections or cancers being transmitted from donor to recipient despite screening strategies, with varying but occasionally very serious consequences to the recipient. There are occasions when organs are offered for transplantation where there are donor characteristics suggesting the risk of disease transmission is increased, and in such cases it is important to balance the risks of accepting the organs against the risks to the recipient of dying without transplantation. These offers form a small but important part of our transplant programme and the overruling principle is of assessing the risk as accurately as possible, balancing that risk against the risk of not accepting the offer, conveying this to the potential recipient in a way they can understand and helping them to decide whether to proceed or decline. Documenting the decision making process is also of great importance. Literature and guidelines It is only in recent years that evidence and guidelines have begun to emerge to help the transplant team and their patients with understanding the risks of donor-derived disease transmission. There have been a number of useful published reviews 1-5 and the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) have issued two sets of guidelines which are relevant 6, 7. Risk of transmission of an infectious disease The unexpected transmission of an infectious disease from donor to recipient is reported in fewer than 1 in 100 donors 5 and the consequences should this occur depends on a number of factors including the type of pathogen, the organ transplanted and the type of immunosuppression used. The SaBTO guidelines on microbiological safety of organs 6 gives specific advice for cases Version: 05 Page 11 of 22 2 nd September 2014

12 of donor meningitis, encephalitis, bacteraemia, abscesses, Malaria, fungal infections, tuberculosis, and Transmissible Spongiform Encephalopathies (TSE). Although all organ donors are screened for hepatitis B/C and HIV, false negative results due to window period infection can rarely occur. The risk of a false negative result increases with certain types of high risk donor behaviour including current or recent intra-venous drug use, commercial sex work, and men who have sex with men. This should be borne in mind when considering organ offers and when obtaining consent from potential transplant recipients (Appendix 1.1). It may be appropriate to accept organs from donors with positive hepatitis serology results depending on a number of factors. In particular organs from donors who have a positive test for hepatitis B core antibody but negative for hepatitis B surface antigen are safe to transplant regardless of the potential recipient s own hepatitis serology (lamivudine prophylaxis should be given for six months post-transplant). Risk of transmission of a cancer There are recent guidelines from SaBTO 7 which are helpful when considering the risk of transmitting a cancer from donor to recipient. Some of the key points from these guidelines include:- Overall the risk of transmitting a cancer from donor to recipient is very low (less than 1 in 2000). Organs from deceased donors with some cancers may be safely used for transplantation. Past or current donor cancers can be divided into contra-indicated, higher and lower risk. Potential recipients must give informed consent and their wishes must be respected Version: 05 Page 12 of 22 2 nd September 2014

13 Protocol Summary 1. Any cases accepted for transplantation where there is an increased risk of donor disease transmission should be discussed with a second senior clinician prior to implantation. This includes all cases of donor meningitis/encephalitis, donors with high risk behaviour, donors with positive hepatitis C or HIV screening tests, and donors with a history of known or suspected cancer. 2. The increased risk of transmission of a donor derived disease should be explained to the potential recipient and they should have the opportunity to decline the organ based on this. 3. For donors with meningitis or encephalitis the SaBTO guidelines 6 should be followed and a consultant microbiologist must be consulted in all cases where the offer is accepted. 4. For organs from donors with high risk behaviour the possibility of a false negative screening test for hepatitis or HIV due to window period infection should be explained to the potential recipient. An estimate of the risk should be given to the potential recipient (see Appendix 1) and documented in the notes. The recipient should be offered postoperative surveillance for hepatitis and HIV. 5. Organs offered from donors with positive hepatitis B or C serology screening results may be appropriate for use in certain recipients. These cases should be discussed with a microbiologist prior to implantation (this discussion may occur during the transplant work-up). Organs from donors who have tested positive for hepatitis B core antibody but negative for hepatitis B surface antigen are safe to transplant without discussion, and recipients of such organs should receive six months of prophylactic lamivudine post-operatively. 6. For organs from donors with a history of known or presumed malignancy the SaBTO guidelines 7 should be used to estimate risk and to guide the decision making process. 7. The case notes must provide a reliable and contemporaneous record of the decision making process, including the discussions between senior clinicians and also between surgeon and recipient. Version: 05 Page 13 of 22 2 nd September 2014

14 References 1. Ellingson et al Estimated Risk of Human Immunodeficiency Virus and Hepatitis C Virus Infection among Potential Organ Donors from 17 Organ Procurement Organizations in the United States. American Journal of Transplantation 11: Kucirka et al Risk of Window Period HIV Infection in High Infectious Risk Donors: Systematic Review and Meta-Analysis. American Journal of Transplantation 10: Kucirka et al Risk of Window Period Hepatitis-C Infection in High Infectious Risk Donors: Systematic Review and Meta-Analysis. American Journal of Transplantation 11: Ison and Nalesnik An Update on Donor-Derived Diseaase Transmission in Organ Transplantation. American Journal of Transplantation 11: Watson et al How Safe Is It to Transplant Organs from Deceased Donors with Primary Intracranial Malignancy? An Analysis of UK Registry Data. American Journal of Transplantation 10: SaBTO Guidance on the Microbiological Safety of Human Organs, Tissues and Cells Used in Transplantation [online]. ata/file/215959/dh_ pdf 7. SaBTO Transplantation of Organs From Deceased Donors With Cancer or a History of Cancer [online]. s_with_cancer_or_a_history_of_cancer.pdf Version: 05 Page 14 of 22 2 nd September 2014

15 Appendix 1.1. Risk of Window period HIV or hepatitis C infection in high infectious risk donors HIV 2 Hepatitis C 3 No high risk behaviour 1 1 in in 5000 IVDU (in the preceding 6 months) 1 in in 100 Commercial sex worker 1 in in 100 Men who have sex with men 1 in in 1000 Version: 05 Page 15 of 22 2 nd September 2014

16 Appendix 2 - PROTOCOL FOR CONSIDERING POTENTIAL KIDNEY AND PANCREAS DONORS WHO HAVE KNOWN OR PRESUMED MENINGITIS OR MENINGO-ENCEPHALITIS Cardiff Transplant Unit Version 1 Author Continuous Improvement Plan Implementation Group Agreed Effective Review date Background The Advisory Committee on the Safety of Blood Tissue and Organs (SaBTO) have issued guidance on considering organs from donors with meningitis or meningo-encephalitis (version 1, issued 21/2/2011, see Appendix 2.1). These guidelines should be carefully followed and any potential recipients counselled as to the risk of donor derived disease transmission. If organs are accepted from such donors the case must be discussed with the consultant microbiologist on call, and an appropriate antimicrobial prophylaxis regimen agreed (see Appendix 2.2). Meningitis The risk of transmission of infection from a donor with meningitis (and the clinical consequences should this occur) are dependent on the underlying organism. Organs from donors with confirmed cases of bacterial meningitis where the causative pathogen is known are generally considered safe to transplant, in which case the recipient should be given appropriate antibiotic prophylaxis (according to the organism and sensitivities). Donors with presumed bacterial meningitis but in whom an organism has not been identified should not be accepted (as per the SaBTO guidelines). Donors with viral meningitis or those with meningitis of unknown aetiology should not be accepted. Encephalitis Potential donors with encephalitis should be considered with extreme caution. The following cases are usually acceptable as kidney/pancreas donors:- Confirmed cases of bacterial meningo-encephalitis where the causative pathogen is known. Confirmed cases of herpes simplex virus without evidence of systemic infection (the recipient should be given antiviral prophylaxis). Version: 05 Page 16 of 22 2 nd September 2014

17 Donors with any other cause of encephalitis or with encephalitis of unknown aetiology should not be accepted. Consent and Documentation The case notes must provide a reliable and contemporaneous record of the decision making process and document the conversation between surgeon and microbiologist. It is the responsibility of the consultant surgeon to counsel and consent the potential recipient and to make sure the notes (and/or the consent form) record this discussion. Review New information and evidence with respect to meningitis and encephalitis in potential organ donors is appearing in the literature regularly as transplant centres report their experiences with these cases. This protocol will be therefore be reviewed six months from the effective date (or earlier should new important evidence become available in the interim). Version: 05 Page 17 of 22 2 nd September 2014

18 Appendix 2.1. Extract from SaBTO Guidance on the Microbiological Safety of Human Organs, Tissues and Cells used in Transplantation (Version 1, , pp ) Bacterial meningitis 9.42 If bacterial meningitis has been confirmed, but there is no visible damage or local infection in the organ or tissues required at retrieval, the donation of the organs, tissues and cells are acceptable Appropriate antibiotic prophylaxis covering any organism isolated from the donor should be considered for identifiable recipients, especially in the case of organs Material from meningitis cases from whom no organism is cultured should not be used for donation Expert advice should be obtained. Viral meningo-encephalitis 9.46 The aetiology of fatal viral encephalitis is difficult to establish If there is any possibility of acquisition of a neurotropic infection from abroad the donation is contraindicated owing to the risk of rabies, West Nile virus or other exotic neurotropic infections If herpes simplex virus (HSV) or varicella zoster virus (VZV) CNS infection is diagnosed as a manifestation of systemic viral infection (as seen in neonates and the immunosuppressed), donation of organs, tissues and cells is contraindicated as the viruses may be disseminated widely with associated viraemia HSV encephalitis without evidence of systemic infection can be treated with antiviral therapy and the likelihood of disseminated infection in the donor is small, even without antiviral therapy. In this situation antiviral prophylaxis should be considered for the recipient Organs can be considered for donation if local HSV/VZV infection has been treated with adequate antiviral therapy for >7 days; if treated <7 days, the recipient should receive antiviral prophylaxis. Serological status of the recipient may also inform a risk and benefit analysis Eyes must not be donated if the donor has a past history of, or active infection with, either HSV or VZV Material from cases of meningo-encephalitis for which no infection is identified should not be used for donation Expert microbiological advice should be obtained. Version: 05 Page 18 of 22 2 nd September 2014

19 Appendix 2.2. Algorithm for considering deceased donor kidney and pancreas organ offers from donors with meningitis or meningo-encephalitis Transplant Recipient Nurse notified by NHSBT of potential donor Consultant Transplant Surgeon on call informed of potential donor Surgeon evaluates the offer by consulting all of the information available on EOS (and discussing with the SNOD if required) and known information about the intended recipient Surgeon considers offer to be potentially acceptable according to SaBTO guidelines Surgeon considers offer to be unacceptable Consultant Surgeon contacts consultant microbiologists on call After discussion Surgeon and Microbiologist agree risk benefit ratio in unacceptable Decline After discussion Surgeon and Microbiologist agree risk benefit ratio acceptable. Any necessary antimicrobial prophylaxis agreed Decline Potential recipient called in to Cardiff Transplant Unit Consultant Surgeon explains to potential recipient the increased risk of donor disease transmission Potential recipient agrees to accept the organ Consultant surgeon or appropriately trained registrar documents in the notes the discussion with the recipient and ensures consent form appropriately completed Potential recipient declines the organ Decline organ or call another recipient (depending on type of donor etc) Proceed to transplantation Version: 05 Page 19 of 22 2 nd September 2014

20 Appendix 3 - NEW CONSENT PATHWAY FOR PATIENTS UNDERGOING RENAL TRANSPLANTS IN CARDIFF TRANSPLANT UNIT Patient receives letter inviting them to meet the Surgeon. Patient information booklet included with the letter, which the patient is advised to read before their appointment with the surgeon. Patient meets the surgeon who makes a transplant assessment in the usual way and explains the risks and benefits specifically for the patient. The patient is offered a copy of the clinic letter. If the decision is to precede with transplantation the patient is invited to another appointment with a transplant nurse specialist who goes through the following points again:- o all aspects of the kidney transplant process and operation o the patient information booklet (including general transplant risks and benefits) o general anaesthesia information and risks o any risks specific to the patient o the fact that they will need to decide whether to accept the donor organ quickly i.e. they will not have days to make the decision o being clear that it is their decision. Family and friends may have their own views, etc but the patient is the one who needs to feel comfortable with the decision o the transplant list consent form The nurse must have good understanding of consent, kidney transplant risks and benefits and anaesthesia. The patient must be aware that they will not be added to the transplant list without engaging with this process. Patient makes decision to go on transplant list and signs consent form. If the patient hasn t been transplanted by 12 months later they will be invited back to see the nurse for a general health review and confirm that they wish to remain on the transplant list When a possible organ becomes available, the patient is asked to attend CTU urgently Where necessary, an interpreter or communication aid is arranged Any specific donor or recipient risks are explained to the patient by the consultant surgeon on call or an appropriately trained registrar, and the details of the discussion recorded in the medical notes and on the consent form. If relatives are party to the discussion their presence should also be documented. The yellow consent form is completed by either the transplant surgical registrar or consultant surgeon and signed by the patient. Version: 05 Page 20 of 22 2 nd September 2014

21 Appendix 4 - CONSENT TO INCLUSION ON KIDNEY TRANSPLANT LIST Patient details label name, dob, address, hospital number, etc If there is anything you do not understand, or if you need any additional information please ask - we are here to help you. You have the right to change your mind at any time, including after you have signed this form. You will be asked to give your consent to a kidney transplant and sign a consent form immediately before the transplant operation. You will be offered a copy of this form. I confirm that - I have been given a copy of the Kidney Transplantation Patient Information Booklet o version.. o dated.. I have attended an appointment with Name.. Role. Date to discuss in detail, all aspects of the kidney transplant process, the general risks and benefits, any risks specific to me and the consequences of not having a transplant (Enter any patient specific risks, areas of concern, etc)... I understand: Version: 05 Page 21 of 22 2 nd September 2014

22 the information that I have been given about kidney transplantation that not all kidneys used in transplantation are of the same quality and that the results after transplantation cannot be guaranteed that I will need to be tested for various viral infections, including Cytomegalovirus (CMV), Hepatitis and HIV, and that these tests will need to be repeated regularly whilst I am on the transplant waiting list that a sample of my blood will be stored in the Tissue Typing laboratory as this may be required in the future for further investigations to benefit me (Excess sample may be used anonymously for quality control purposes, ethics committee approved research, service development or education. Please tell us if you are not willing for excess sample to be used in this way.) that, in the event of a transplant taking place, I will be given general anaesthetic and I understand the risks associated with anaesthesia The following organ characteristics are not acceptable to me... I agree to my inclusion on the Kidney Transplant List (to be completed by the patient) Signed Print Name Date I have explained in detail the kidney transplant process, its risks and benefits, and any alternatives, to this patient (to be completed by the healthcare professional) Signed Print Name Date Designation Version: 05 Page 22 of 22 2 nd September 2014