NHS BLOOD AND TRANSPLANT 30 JANUARY 2013 CLINICAL GOVERNANCE REPORT

Transcription

1 14/14 NHS BLOOD AND TRANSPLANT 30 JANUARY 2013 CLINICAL GOVERNANCE REPORT 1. INTRODUCTION Clinical Risk There are currently 43 risks on the corporate risk register which are listed with clinical as the dominant risk. Of those, nine have a residual risk rating of 15 or more, eight which have been reported previously: IT capacity and functionality at a data centre or major processing location is lost or compromised as a result of failure of infrastructure or service Organs being taken for transplant against the wishes of the donor. The implementation of presumed consent legislation in Wales and other devolved administrations alongside the existing opt in system means that different systems may result in confusion as to which system applies and subsequent errors in determining and implementing the donor s wishes. A failure of the Hematos system making it unavailable for a length of time that causes patient harm (currently thought to be 2 hours). There was a prolonged Hematos outage overnight on 4 Dec Contingency procedures were implemented successfully and there was no harm to patients. An uncontrolled or insufficiently tested change is made to a business process or application with unintended negative consequences. Harm or death of a transplant recipient or transplant recipient disadvantaged by not being offered a suitable donor organ or being offered incompatible/unsuitable donor organ due to complex and manual systems in the Duty Office. Harm or death of a transplant recipient or transplant recipient disadvantaged by not being offered a suitable donor organ or being offered incompatible/unsuitable donor organ due to o Incomplete or inaccurate data entered onto NTxD or EOS o Failure to follow agreed procedures. o Verbal instructions or information misunderstood and or not actioned appropriately. The purchase of PRUK (including the Elstree site where our data centre is located) by Bain Capital may have a negative impact on the service we receive at that site. A failure of the Pulse system making it unavailable for a length of time that causes patient harm (currently thought to be 72 hours) There is one new risk with a residual risk rating of 16. Reduction in timeliness of services provided to hospitals and potential for SNOD and NORS team non-attendance. Page 1 of 10

2 This risk is due to the fixed funding arrangement for ODT whereby funding is by block grant irrespective of levels of activity, which may mean that rising activity levels cannot be sustained. The Board are seeking a high level meeting with the four health administrations to review funding levels and sustainability and ODT staff are reviewing business continuity/emergency plans to identify 'low risk' activities to be discontinued in the event of peak activity. Clinical Audit KPI The clinical audit KPI which tracks the number of overdue clinical audit actions as a percentage of all open actions within a directorate is currently at 0% for all three operating directorates. Clinical Audit Final Reports Two clinical audit final reports were considered and approved by the CARE committee. 1. Re- audit of Transfusion Knowledge and Practice in Therapeutic Apheresis Units This re-audit aimed to provide assurance of improvement the knowledge of transfusion practice of STS staff following implementation of actions following the initial audit. The results continued to identify residual apparent gaps in knowledge, but flaws in the questionnaire design were identified, leading to possible overestimation of the knowledge gaps. Anonymisation of the audit meant that individualised feedback could not be given to participants; the outcome of the audit has been fed back to all staff and update training provided.. Future audits of transfusion knowledge, based on a new questionnaire, will not be completed anonymously and individual feedback will be provided. STS staff are not allowed to take samples, collect or administer blood components until they have been assessed as competent. Competency testing is undertaken for each staff member annually and documented in training records and knowledge is tested every three years.. 2. Audit of Clinical Concessions Logged Against the Sample Labelling Policy in H&I Occasionally the labelling of samples received in the H&I laboratories does not meet the minimum standards required, but any delay in testing may have an adverse effect on the patient. At the discretion of senior H&I staff, an incorrectly labelled sample may still be tested under concession. In 2012 there were 138 clinical concessions reported (clinical concessions are reported as quality incidents). The aims of the audit were to assess if the standards are being applied consistently, including documentation in laboratory records and inclusion in the report to the requester that the test has been completed under concession. In addition, the audit intended to identify whether there are hospital departments that consistently fail to correctly label samples which would warrant specific feedback. Page 2 of 10

3 Samples are referred to the H&I laboratories from both hospitals and GP practices. Samples are referred from patients and donors, either living or deceased. To ensure patient safety, samples referred need to be labelled in accordance with the guidelines detailed in MPD637 Requirements for Sample Labelling and Request Form Completion. The results confirmed that overall most samples are labelled correctly. There are a small number of hospitals that refer about 1% of all samples that do not meet the minimum standard and these are often pre-transfusion samples. All hospitals will be informed of the audit findings and reminded of the correct process for sample labelling. A rapid improvement event is planned to standardise practice across all six H&I sites. The timing of a re-audit or alternative ongoing monitoring will be discussed after the rapid improvement event. CQC Inspection Update Since the last report there have been three CQC inspections. The Liverpool STS Unit was inspected on 13 January 2014 and a formal report is awaited but postinspection feedback indicated that all outcomes inspected were achieved. Oxford is the only remaining STS unit that has not been inspected in this financial year but the CQC have indicated that this inspection is likely to take place in the next few weeks. All four other STS units inspected in have been fully compliant against the standards assessed. There have also been two inspections of blood donation sessions at Leeds (and the associated mobile session at Knuttingly) and Edgware on 2 and 7 January 2014 respectively. A draft report has been reviewed following the Leeds inspection, which confirms that all outcomes inspected were compliant. Feedback from the Edgware inspection also indicated all outcomes were compliant. The CQC have indicated that they will be inspecting blood donation sessions at Bristol Southmead, Oxford, Southampton and Plymouth in the near future. NHS Mandate and Outcomes Framework In November 2013 the Government published an update to the NHS Mandate for 2014/15. This sets out the Government s objectives for NHS England, and together with the associated Outcomes Framework document is the primary accountability mechanism between the Secretary of State for Health and NHS England. There are five domains in the documents Preventing people from dying prematurely Enhancing quality of life for people with long-term conditions Helping people to recover from episodes of ill health or following injury Ensuring that people have a positive experience of care Treating and caring for people in a safe environment and protecting them from avoidable harm Whilst NHSBT is not an NHS England commissioned service and the documents have little impact on NHSBT as a Special Health Authority, many of the principles and indicators set out in the documents will have some relevance and offer an opportunity for an assessment of NHSBT s quality of care. The overriding principle is that patients and donors should expect to be cared for with dignity, compassion and respect. The CARE Committee members have been asked to discuss the NHS Page 3 of 10

4 Mandate at their CARE group meetings to make the senior clinical teams aware of the documents and make sure that the principles are enshrined in their policies and guidance. Hacking Attack In mid-december 2013 NHSBT was subject to a sustained hacking attack from China, India and Germany seeking to break into NHSBT IT systems. The attack focussed on two areas our primary internet connection and the systems used to securely transfer files externally to other organisations. The pattern of the attacks is consistent with those seen on many organisations with an initial attack designed to distract whilst seeking to gain access to secure transfer services. The latter is normally assumed to be carrying sensitive financial data, although in our case it is used for protecting sensitive patient data. No breaches of NHSBT security occurred and a lessons learned event is taking place to ensure we continue to operate a secure set of IT services. This is the first significant incident of its kind and is assumed to have not been targeted directly at NHSBT for any specific reasons other than the presumption that as a government agency we would be an easy target. 2. ORGAN DONATION AND TRANSPLANTATION In December 2013 some NHSBT staff visited the offices of Eurotransplant to discuss and compare governance processes and begin discussion about possible future benchmarking and sharing of best practice. The team from Eurotransplant will visit Stoke Gifford in early February Incidents In November 2013 there was an increase in incident reporting across all subgroups with around incidents reported in the month period and three incidents were reported to the HTA as SAEARs; two serious adverse events in which organs were damaged and not transplanted (one pancreas and one kidney) and one SUI of a donor malignancy that was not recorded on EOS at the time of offer (reported in the November Board SUI Summary report) There have been no new SUIs or PoSHIs reported. Clinical Complaints The complaint received in September 2013 from the recipient of the HLA mismatched heart that was investigated as PoSHI INC218 is ongoing. There has also been a complaint from the family of a deceased kidney recipient and formal notification of a claim is expected. The Procurator Fiscal has contacted ODT expressing concerns that prolonged donor retrieval time for a donated liver may have impacted on the graft outcome. There was primary non-function of the liver in question and the patient underwent a second transplant and subsequeblty died. The NHSBT investigation has concluded that the retrieval did not have any adverse effect on the graft outcome and there is ongoing discussion with the Procurator Fiscal. An interim report has been provided to the Procurator Fiscal and a copy of the final investigation report will be provided in due course. Page 4 of 10

5 Clinical Microbiology A tissue donor, tested because of travel history, was found positive for T Cruzi and Malaria antibodies. The donor had also donated organs, and the results were provided to the transplant teams. No recipient was harmed but it is understood that after discussions with the World Health Organisation, prophylaxis is planned for one of the recipients but the other will be closely monitored in the first instance. A review of the incident identified a number of areas for improvement, including a review of the potential actions that arise from information included in the form which details donor history (PA1 form). A working group has been convened which will review the action for malaria testing of organ donors based on travel history, and when this group has reported to ODT SMT in February 2014, proposals will be extrapolated for other infections. Recognised Serious Complication Incident A deceased donor died from an unidentified meningo-encephalitis. Organs were offered and both kidneys accepted for two recipients in the same centre, after being fast-tracked. All relevant information was made available through EOS at the time of referral. The surgeon sought expert microbiological advice from a local colleague and, after balancing the risks and benefits of accepting the organs and after discussion with the recipients, transplanted both kidneys. Both recipients developed an illness similar to that seen in the donor and died. The cases were reported to the HTA. NHSBT has worked closely with Public Health England and the local team to identify the cause of the encephalitis and ensure public safety. The cause of the fatal infection was a nematode, a rare cause for encephalitis and exceptionally rare cause of donor transmitted infection. The AMD ODT has liaised closely with the Medical Director of the recipients' hospital and has supported an external review which will be shared with NHSBT. The AMD has also shared this case with transplant clinicians and will be included in the February2014 issue of Cautionary Tales. Pending the findings of the enquiry, our initial view is that all involved followed proper procedures, did a risk assessment, sought advice, consented the recipients and that this is a very sad example of a donor transmitted infection, showing that risk can be mitigated but not abolished. A lessons learnt workshop with NHSBT & Public Health England to be arranged for March BLOOD SUPPLY Transfusion Transmitted Infection (TTI) There have been no bacterial transfusion transmitted infections reported in this financial year. One case of possible post-transfusion viral infection has been closed since the last report with no evidence of transmission and there are three ongoing investigations. Page 5 of 10

6 Incidents Re-bleed and faint rates remain stable. Serious Adverse Events of Donation (SAEDs) There have been nine new serious adverse events of donation since the last report, eight of which have a definite or possible link to donation and one which is unrelated. Five of the incidents relate to needle insertion issues, two hospital admissions (one delayed faint and one diagnosis of silent migraine which is possibly linked to donation), one unrelated acute coronary syndrome and the potential serious complication incident detailed below. One donor who has experienced a painful arm since his last donation wishes to continue to donate but all other donors have been withdrawn. Serious Adverse Blood Reactions and Events (SABRE) There have been four new Serious Adverse Blood Reactions and Events reported in October and November Two incidents relate to a failure to recall components within the required timelines. These two incidents are being managed under a national quality incident, (which is a separate and third SABRE incident), with a full review of the recall process due to present to the BS SMT in January A further incident occurred when 173 units in Colindale were not manufactured in a timely manner and were either discarded or set for reagent use. Recognised Serious Complication Incident INC46815 A 17 year old first time donor gave blood on a blood mobile at a school donation session in November The donor found the venepuncture very painful and was told that the pain would settle down. Towards the end of the donation, the flow rate slowed and when the donor carer removed the tape securing the needle in order to perform a needle adjustment, the needle fell out spontaneously with a blood spill reported by the donor. The donation was discontinued. The standard dressing was applied but no further advice regarding post-donation care of the arm in the event of bruising was given. The donor was admitted to hospital later that day with extreme pain and swelling, and presumed arterial puncture diagnosed. He was subsequently in hospital for two days and scanning revealed a pseudoaneurysm of the artery. The surgeons advised surgery as the pseudoaneurysm initially failed to heal. However, on the day of the planned, surgery some improvement was noticed and eventually the aneurysm began to heal without surgery. The donor is now back at school and the arm is improving but the haematoma and movement are not yet fully back to normal. The clinical support team and Associate Medical Director have kept in close contact with the family throughout and a letter of apology sent. Recognised arterial puncture is a rare complication of donation which staff are trained to recognise (occurring in 1 in 10,000 donations in NHSBT). If there is an arterial puncture blood flow is usually fast and the blood bright red and sometimes frothing. This is treated by 10 minutes of manual pressure and specific written advice is given to the donor.. Data from the American Red Cross estimates that only 1.5% cases of arterial puncture result in a pseudoaneurysm (the last case in Page 6 of 10

7 NHSBT occurred in 2011). None of the reports from the literature describe pseudoaneurysm occurring after what appears to be a normal venous donation. Root cause analysis has established that there were none of the usual signs of arterial puncture during this donation, other than pain. The arterial puncture is thought to have occurred by the tip of needle exiting through the back of the vein into the artery whilst the blood drained through the needle bevel in the vein; hence the donation took the usual time (11 minutes), was the usual colour and no frothing was observed. Arterial puncture was not considered as a possible cause of the needle dislodging, nor of the pain reported. As a result of this incident, processes have been changed to instruct manual pressure on the arm (i.e. treat as if arterial puncture) if a needle falls out of the arm, as this is a rare event. An action plan is in place which will stop Blood Mobiles being used for school sessions, to allow more nurses to be present where sessions have a higher proportion of young donors. We will survey how often donors give us information that may suggest we have missed an arterial puncture and we will look at what how often unusual events such a needles falling out occur, and examine what this may mean Safeguarding There have been no new safeguarding incidents. Complaints There has been no increase in the number of clinical complaints received. 4. DIAGNOSTIC AND THERAPEUTIC SERVICES Transfusion-Related Acute Lung Injury (TRALI) There have been no new cases of TRALI since the last report leaving the total number in this financial year at three. The previously reported incident in which a Coroner requested a case review because the clinical situation of a patient who died looked like TRALI has been reviewed and has been classified as being unlikely to be TRALI. A formal response has been provided to the Coroner. Incidents No trends in patient adverse events have been identified and there have been no new SUIs or PoSHIs. There has been one incident in which a surgeon ordered a graft for triple fusion of a patient s foot for hrs but which did not arrive in the theatre until hrs which resulted in the surgeon undertaking a procedure that he had not anticipated. The surgeon does not believe that the patient s outcome has been compromised and has been offered an apology. The investigation has been taken up with the courier service which delivered the graft. Page 7 of 10

8 Claims and Complaints No trends in hospital complaints have been identified. The patient who had made a complaint previously about autologous serum eyedrops via their MP has made a further complaint about the change of practice required by the MHRA for a prescription for the provision of eyedrops, which resulted in a delay in provision of the product. A full explanation has been given and the patient did not experience a gap in supply. More positively, the MHRA have confirmed that the allogeneic serum eyedrops service can be provided under the specials regulations for unlicensed medicines and that eyedrops can be issued directly to patients. There has been contact from a solicitor on behalf of a stem cell donor that donated in December 2012 requesting copies of our policies and procedures relating to consent and stem cell donation. There was no incident or complaint related to this donation but at the solicitor s request the clinical records have been disclosed but to date there has been no formal claim against NHSBT and as yet it is not clear what a claim would relate to if it were to be made. The donor s solicitors are also making enquiries with the Trust the carried out the treatment. 5. SAFETY Science and Technology House of Commons Inquiry on blood, tissue and organ screening. Following a one-off session on 27 Nov 2013 at which three papers on vcjd were reviewed, the House of Commons Science and Technology Committee is holding an inquiry into blood, tissue and organ screening, against the following Terms of Reference:- 1. Are UK policies governing who can donate blood and blood products, tissues and organs sufficiently evidence-based? Is NHS Blood and Transplant overly restrictive about who can donate, or should greater precautions be taken to further reduce risk? 2. Is the Government and its scientific advisory structure sufficiently responsive to the threat posed by emerging diseases being transmitted through blood and blood products, tissues and organs? 3. Has the threat of ongoing transmission of vcjd through the blood and blood product supply been adequately mitigated? 4. What are the strengths and weaknesses of NHS Blood and Transplant s strategy, Taking Organ Transplantation to 2020? What further changes could be made to safely increase the supply of blood and blood products, tissues and organs? 5. What lessons could be learnt from the screening and donation practices of other countries? A call for submissions was distributed widely, with a 15 th January deadline. Following internal discussions, including UK Forum, the following papers have been submitted:- 1. A review of Blood Service steps to mitigate vcjd risk, led by Professor Marc Turner, Chair of UK Blood Services Prion Working Group 2. A review of arrangements and actions to ensure the safety and supply of blood, tissues and cells, led by myself and Dr Sheila MacLennan on behalf of JPAC Page 8 of 10

9 3. A review of organ supply and safety, led by Professor James Neuberger on behalf of NHSBT 4. A review of haemovigilance arrangements, findings and recommendations, led by Dr Paula Bolton-Maggs, Medical Director of SHOT. Separate submissions have been made from DH (on blood and organs), and from SaBTO, which has taken the lead over the last 10 years in formulating policy with regard to vcjd risk mitigation. Following review of the submissions by the committee, it is likely that some or all authors of papers will be called to give oral evidence in the next 3 months, following which a final report will be published. SaBTO A. Prion Sub Group review of the effectiveness and cost-effectiveness of the collection of 80% of platelets by apheresis as a vcjd risk reduction measure. The recommendations to remove the 80% apheresis mandate and implement Platelet Additive Solution have now been noted by ministers in the four health administrations. The report has been published and a project group established within NHSBT to consider the required changes. The sub group also submitted a report on the status of all vcjd risk reduction measures to SaBTO in December This recommended that all other current risk reduction measures should remain in place and unchanged. SaBTO accepted this recommendation and the report has now been published. B. Pathogen Inactivation of Platelets Working Group. The working group, chaired by myself, submitted a final report to SaBTO in December 2013, which was accepted. The report is anticipated to be published in late January C. Hepatitis E Working Group A joint HPE/NHSBT study to assess the prevalence of Hepatitis E virus is completed, and is due to report in the near future. SaBTO will now convene a short life working group, chaired by myself, to review this and other evidence, and consider options regarding screening and other steps to mitigate the risk. The group is expected to report to SaBTO in late Epidemiology Middle East Respiratory Syndrome Coronavirus (MERS-CoV) The numbers of confirmed cases have reduced and MERS-CoV is not currently regarded as a significant threat within the UK. WHO have advised that no special screening measures are required of travellers returning from the Middle East at point of entry to their home country. WHO has advised ongoing vigilance and monitoring. Page 9 of 10

10 Club 96 A. EBV, CMV and Parvovirus B19 Prevalence Study The prevalence study has been initiated, with the relevant samples for analysis identified and the testing processes finalised. Results are anticipated in late summer, and will be considered by SaBTO as part of an overall Club 96 risk assessment. B. Donor Recruitment 33,000 people born after 1 Jan 1996 have registered to be donors to date. Of these 7,860 are currently active donors; a further 6000 have attended but are currently suspended, reflecting high deferral rates in young donors due to low weight or haemoglobin, travel to malarious areas and body piercing. The majority of the remainder have yet to attend. Approximately 11,250 donations have been made so far by Club 96 donors which is marginally less than the 13,788 anticipated through modelling. Donor Compliance Study The donor compliance study has been renamed - PHE UK donor survey. The study went live in England on 4 th November A spot check on day one showed a 10% response rate. Wales, Scotland and N. Ireland are expected to go live in January. Acupuncture Following a meeting with the British Acupuncture Council, a proposal to collect new data to inform a review of acupuncture risk is under consideration by the epidemiology team and BS CARE. Authors: Ruth Adam Assistant Director Governance and Clinical Effectiveness Andrew Broderick Safety Programme Coordinator Approved by: Lorna Williamson Medical and Research Director Page 10 of 10