R12-44 final clinical governance board report may 2012.doc
NHS BLOOD AND TRANSPLANT
24 MAY 2012
CLINICAL GOVERNANCE REPORT
There are currently five risks on the clinical risk register with a residual risk rating over 15. There are three risks reported previously:
1. NHSBT process leads to inappropriate/incorrect treatment (as a result of
transcription errors, failure of irradiation processes, multiplatform information (e.g. fetal blood groups on different platform from routine data).
2. Incomplete or inaccurate data entered onto NTxD or EOS.
3. Organs may be found to be covered by the consumer protection act (CPA) and
therefore organs that are currently considered to be suitable for transplant can no longer be used.
These risk have been reviewed thoroughly by GAC and mitigation plans accepted.
There are two newly added risks from the ODT risk register:
4. Inability to update key systems, implement new systems or correct system
errors. This overarching risk was added after investigation of the Duty Office incident concerning a superurgent liver. A mitigation plan has been devised.
5. Insufficient supply of perfusion fluid for abdominal transplants. This is discussed
below and will be downgraded when the risk register is next reviewed.
A review of the blood donation clinical risks has been completed. There are no risks with a residual risk rating of 15 or over. The risk from delayed faints, which is a known adverse event following blood donation, has a residual risk rating of 12.
The CARE committee approved a paper detailing how the Statistics and Clinical Audit and Quality Assurance audit functions are going to work together to improve risk assurance. This includes topics for joint quality/clinical audits. The 2012/13 Clinical Audit Programme was approved by the committee - the new format now details the distinct links between each clinical audit and risk registers, incidents, regulatory requirements and the strategic plan. Revised processes to ensure that all reports and proposals for clinical audit have timely and appropriate approval were also signed off by CARE.
Care Quality Commission
Based on a status review against CQC outcomes, the main areas for improvement relate to medicines management and safeguarding.
The Medicines Management issue relates to the storage, transportation and audit trail of Lidocaine in Blood Donation. A detailed paper was submitted for BD SMT approval on 10 May 2012 which included the following recommendations to meet the standards
Team bases with authorised personnel access only - install key cabinets
Donor Centres (and premises with public access where Lidocaine is stored)
install Level 1 security medicines cabinets and key cabinets as described
Provide all mobile teams with secure transportation containers. Implement audit trail documentation in all areas where Lidocaine is
stored/administered and maintain records of keyholders
In order to achieve compliance with the new CQC Safeguarding standard a work plan has been produced and a quote for external expertise to complete the work has been formally requested. A steering group which will oversee the work has been established.
The corporate communication plan to increase staff awareness of the CQC and ensure they are well prepared for an inspection is ongoing and being monitored.
A follow-up meeting the CQC has been planned for 12 June 2012.
The minutes and papers of the SaBTO meeting held on 9 March 2012 have been published on the Department of Health website. The meeting scheduled for 29 May 2012 has been cancelled as there are no items requiring decisions at this time. Instead, a briefing pack of documents will be supplied to members for their review and comments. These will include terms of reference of new working groups and the annual report.
As previously reported, SaBTO recommended in March not to extend the use of imported FFP beyond those born since 1 January 1996 and high-usage adult patients. DH have written to NHSBT, the National Blood Transfusion Committee, and the British Committee for Standards in Haematology to advise on this decision. NHSBT will formulate its strategy for frozen components this will be led by the Components Strategy Group, and overseen by the Therapeutic Products Safety Group. This work will include the use of the safety framework to assess the options for sourcing of frozen components. Recommendations will come to ET and Board by the autumn.
The UK Forum Club 96 Working Group has held its first meeting and confirmed its terms of reference and workplan. The primary aim of this group, chaired by Lynda
Hamlyn, is to establish operational plans for supplying patient groups not previously exposed to vCJD with blood components sourced from donors born after 1 January 1996 as soon as possible after they become eligible to donate. SaBTO will advice on the relative safety of this donor group in relation to other risk reduction measures in place.
Following the recommendation to change the MSM deferral period for blood donors, a SaBTO working group on tissue and cell donor selection has been established. Terms of reference have been agreed, and letters of invitation will be going to representatives of stakeholder groups shortly. Lorna Williamson is the chair of this group.
SaBTO is keen to see further work on donor compliance. Activities which have been explored with the HPA/NHSBT epidemiology group include structuring interviews with virus positive donors to explore possible non-compliance (implemented); reviews of any changes in donor demography followng the MSM change (implemented), a new survey of donor compliance (under discussion), and a new study of compliance by MSM.
Hospital customers were sent a letter to draw their attention to the recent SaBTO position statement regarding which patient groups should continue to be provided with CMV negative blood components and which need not. The potential impact of these recommendations is to reduce significantly the demand for CMV negative components, particularly platelets. The letter was accompanied by a report detailing their orders of CMV negative components in 2011/12 and asked for an indication of the hospitals likely future ordering plans. Of 260 hospitals, 89 have so far responded, with 86 expecting to reduce their orders for CMV negative components. Larger hospitals were more likely to reduce their orders significantly. Many hospitals have indicated that it will take several months for them to reach a decision on whether to follow SaBTO guidance.
3. ORGAN DONATION AND TRANSPLANTATION
Improved consent procedures for families of deceased organ and tissue
In late 2010, a complaint was received regarding the excessive amount of information given to families during consenting procedures for tissue and organ donation. A working group was therefore convened to work with HTA and donor families to develop new procedures. The group reviewed international practices, and an independent review was also undertaken by a Professor of Discourse and Cultural Studies.
A minimum core dataset was agreed with HTA, and a revised suite of documents (forms and information leaflets) has now been approved. The procedure now prompts the nurse to ask the family how much information they would like to have, by grouping organs and tissues together and then breaking them down if the family wish. The new procedures also make provision for 'generic' research consent rather than giving complex details on individual projects.
The original scope of the work also included review of authorisation practices in Scotland. At the request of the Scottish Government Health Department (SGHD) this work was temporarily halted, but it has been recently agreed that this will recommence in June.
This has been an excellent piece of work. Implementation of the recommendations will improve the experience for donor families on whom we depend, and provide greater organisational assurance that their views have been taken into account in the consent process.
Viaspan organ preservation fluid
In March, MHRA reported that batches of Viaspan, a fluid used in the preservation of abdominal organs during retrieval, storage and transportation, may have been contaminated by Bacillus cereus
This followed detection of B cereus in the production line, although not in the product itself.
All organ retrieval teams and transplant centres were advised of the potential contamination of the product but given the lack of a licenced alternative solution in the UK, it was advised that Viaspan could continue be used until a suitable alternative preservation solution was sourced.
NHSBT took a lead role in co-ordinating actions and communicating with transplant centres. Working with MHRA and DH, NHSBT urgently procured sufficient stocks of alternative fluids. Three alternative suppliers were found and, with due consideration of the risks associated with just one manufacturer providing fluids for the entire National Organ Retrieval Service, the tender was awarded to all three providers. Sufficient stocks have been purchased to cover retrieval activity for six months, and fluid will be shipped from the manufacturers to the retrieval teams as and when requested.
NHSBT continues to liaise with the MHRA and the HPA to ensure their messages and any updates on the contamination issue are transmitted to the transplantation community. A learning exercise was held within NHSBT on 4 May, and a similar multi-agency event is planned. Outputs from these exercises will be reviewed for application across NHSBT eg on supply of critical consumables.
Draft intestinal selection and allocation policies are under review by the ODT CARE group. Selection and allocation policies for hearts and lungs are expected to be completed by the end of the year.
As part of the introduction of a quality management system for ODT, document control of all ODT policies is being undertaken. Once the revised selection and allocation policies are completed these will also be entered into the controlled document library.
Short term outcomes following organ transplantation are monitored using cumulative sum (CUSUM) methodology. CUSUM charts are designed to monitor individual centre performance over time by comparing current outcomes at each
centre with their own past performance. Reports are produced on a regular basis and are sent direct to individual centres to assist in internal auditing and enable prompt detection of any changes in mortality or graft failure rates. Reports are received by the ODT CARE group who monitor any changes known as signals in the data and follow up any issues identified with the individual centres.
There were no new signals reported at the CARE committee meeting.
All actions on the action plan for SUI 393/1010 (measurement for lung transplant) have been completed and the action plan closed.
A root cause analysis has been undertaken for the incident in which a patient registered for a super urgent liver transplant was registered on the National Transplant Database but was not offered the next available suitable liver because of an administrative error (CGMG 954/0312). The root causes identified included:
1. Standard Operating Procedures are not yet formally controlled and issued through the Quality Management System, nor used to generate staff training. . This will be resolved when the QMS is embedded in ODT later this year.
2. Patient-specific criteria are captured and recorded in NTxD but is not used in the creation of a matching run, and centre-specific criteria are not captured or recorded in NTxD. This has contributed to operational work-rounds and over-reliance on ad hoc systems for recording critical information.
3. The increase in transplant activity, leading to multiple cases being handled simultaneously by the Duty Office staff, can generate frequent distractions, particularly by telephone, which may increase the risk of errors and failure to prioritise tasks. This increase in activity highlights the importance of formal handovers between shifts.
An action plan based on the root causes identified has being compiled, and will be monitored by ODT CARE.
Claims and Complaints
4. BLOOD DONATION
West Nile Virus testing
The policy of NAT testing for West Nile Virus for travellers returning from affectd areas came into force on 1 May. The impacts will be monitored and reported to the Board.
The previously described significant reduction in faint rates is being sustained.
The annual review of Serious Adverse Events of Donation of 2011 shows broadly similar statistics to previous years. The biggest exception is for hospital admissions more than 24 hours post donation which have risen to over 20 per year. This mirrors Hospital Episode Statistics, which, in response to a change to national guidance, show an increase in Accident and Emergency departments admitting people who collapse for observation to exclude cardiac and neurological events.
There have been two new SAEDs since the last report, both delayed faints (one of which resulted in a fracture). Two other events were not thought to have been caused by donation.
One complaint from a donor who complained about a deferral for acupuncture has written to the complaints Ombudsman. The initial response sent to the donor was not the standard clinical response. Additional information has been provided to the Ombudsman and a decision is awaited.
5. PATIENT SERVICES
Therapeutic apheresis services in Manchester.
A letter has been sent from the Chief Executive of NHSBT to the Chief Executive of Central Manchester University Hospitals NHS Foundation Trust regarding the lack of availability of a comprehensive therapeutic apheresis service for patients in Greater Manchester, Lancaster and parts of Cheshire. This has resulted in ad hoc referrals to NHSBT s STS teams in the NW, placing them under undue strain and potentially compromising the service we provide to Trusts with whom we have SLAs. We have offered to meet with hospital management staff to agree a way forward.
As a result of previously reported staff training initiatives and rapid improvement events there has been an ongoing downward trend in the number of reconciliation failures reported nationally.
Safe and Appropriate Use of Blood
A Better Blood Transfusion event Patient Blood Management - The Future of Blood transfusion will be held on 18 June 2012 in London with key note speakers, Sir Bruce Keogh and Lynda Hamlyn.
Transfusion-Related Acute Lung Injury (TRALI)
There have been no new cases of TRALI reported with only one reportable case during the 2011-12 financial year, which is within NHSBT s target range for such events. A Coroner recently recorded a narrative verdict of TRALI in an 87 year old female patient who would be classified as unlikely to be TRALI by haemovigilance
criteria, and would not be reportable as TRALI by NHSBT as the donor did not have antibodies and there were other reasons for the changes in the lung.
Transfusion Transmitted Infection
There have been no confirmed cases of transmission of bacterial infection in blood components in 2011-12 which meets the defined target.
A near miss was reported in which a pack of red cells contaminated by a bacterium, Pseudomonas fluorescens
, was identified as a result of visible discolouration by a hospital transfusion laboratory. The pack was not transfused and therefore there was no patient harm. There was no evidence that a defective pack, NHSBT facilities, staff or the donor were the source of contamination which is consistent with international experience when such an organism is identified.
For the first time since 2005, there has been a virus transmission from blood components. The hepatitis B virus has been transmitted from two components (plasma and red cells) made from one donation to two recipients. The infection was detected by reference tests when NHSBT was notified that the recipient of the FFP had developed Hepatitis B. This recipient has been seen by an NHSBT consultant, and is now recovering, having cleared the virus. The red cell recipient has not been reported as having clinical disease, although tests positive for hepatitis B virus.
A thorough investigation has revealed no failures in the donor health check prior to donation or in testing procedures. Reference testing in Colindale is consistent with the donor having been in the very early window phase of infection, below detection levels of NAT. The donor has been interviewed and no reasons for donor deferral have been identified.
Hepatitis B is a recognised but now rare complication of transfusion. It continues to be included in patient information material. Neverthless, we will consider whether more could be done to reduce this risk further. The safety framework will be used to review options for hepatitis B testing and pathogen inactivation of FFP; international surveys are also being conducted.
Two delayed recalls of platelets which had initial reactive bacterial screening
results have been reported.
There was no harm to patients, and in both cases
confirmatory testing proved negative. There was a specific local training issue
which has been addressed and a training package detailing the responsibilities and
handover methodology has been delivered to all staff involved in the process. An
automated report to simplify reconciliation of all positive screens is being validated
to further simplify and improve the process.
An incident has been reported in which a unit of red cells from a donation that had been repeatedly reactive in a screening test for Hepatitis B was issued in error and promptly successfully recalled. It was subsequently confirmed that the donation was negative by reference testing. An increased rate of void results has been linked to a single batch of reagents and is being investigated further with the manufacturer.
There have been three reported incidents of mislabelling of units in manufacturing departments. There was no patient harm and internal systems detected the errors before the release of products. Having more than one pack in front of the operator when undertaking a process was identified as a significant contributor, as were interruptions. A training package has been re-delivered to all staff undertaking this process highlighting that there must be only one product in front of the operator at a time and the serious potential harm to patients that failure to observe best practice can cause. An additional supervisor has been recruited to cover the area involved in two of the three incidents. The standard operating procedure governing this process (SOP3062) is being amended to incorporate this. Labelling has been identified as a high priority area for internal audit.
The International Blood Group Reference Laboratory has reported a transcription error that led to the issue of an erroneous report of a fetal blood group. This did not lead to patient harm and there was no evidence of a systematic error but an investigation is underway.
Claims and complaints
There have been no new claims or complaints of note.
Assistant Director Clinical Operations and Governance
Safety Programme Coordinator
Approved by: Lorna Williamson
Medical and Research Director
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