APPENDIX 1: DETAILS OF EXTERNAL INSPECTION FINDINGS CPA COLINDALE - MARCH 2012

Transcription

1 APPENDIX 1: DETAILS OF EXTERNAL INSPECTION FINDINGS CPA COLINDALE - MARCH Others: Sample acceptance and rejection states transit time for samples in broth must not exceed 48 hours and for transfusion reaction samples seven days. As the laboratory is not recording transit times, it cannot ensure that it complies Samples should be considered for rejection by a senior member of staff if they have been more than seven days in transit. In reality samples are never rejected but this may compromise the integrity of the result Manufacturer s instructions in use in the laboratory are not under document control The document control procedures do not specify who will be the owner and approver to authorise documents NBL documents The Specification for NHSBT record storage does not specify which records are actually stored by the National Bacteriology Laboratory. The local policy POL 1571 does not cover all records which may be stored in the department prior to transfer to long term storage at Iron Mountain. Records of training, personnel records and stock control are not covered in this SOP Sample transport has not been audited transport arrangements to ensure that health and safety requirements are met and specimens are protected from deterioration NEWCASTLE - FEBRUARY Others: Details in some SOPs and datasheets were weak The approved request to disable the Thermogenesis did not record the reason Change control for Macopharma Blood Packs did not provide predefined acceptance criteria for the reviewer to accept against Bact Alert Laboratory- trigene sprayed when environmental monitoring plates exposed, hand wash soap dispenser empty, hand wash taps not designed to minimise the risk of bacterial contamination Donation number validation was weak Adverse events are not trended by root cause 5 Comments: NHSBT should hold copies of all data input into the Sabre system as does not guarantee to hold this for the period required by BSQR (Note: We do) Hospital Services should consider regular trend analysis of Contronic temperature alarm data NHSBT should seek confirmation of destruction for POD medicinal product supplies sent for incineration NHSBT staff were working on developing a clearer understanding of IR and confirmed / indeterminate positives from bacterial screening. This will be included in an update to Provide evidence that removal of discard holds cannot be done by any member of staff within the Pulse system. If it is allowed please confirm and justify under what circumstances this is acceptable. 1

2 OCTOBER TO DECEMBER 2011 Birmingham EFI Histocompatibility & Immunogenetics December Others 2 Comments HTA Leeds, SCI and STS St James s Hospital - December Others 5 Advice and guidance Birmingham - November Others 1 Comment Southampton Donor Suite - November 2011 No findings to address JACIE Leeds (SpS\Stem Cells) October 2011 No findings to address Sheffield - October Others 1 Comment Liverpool, Underwriters Laboratories, reagent Production - October 2011 No Findings to address British Standards Institute, Business continuity (ISO 25999) October Other JULY TO SEPTEMBER 2011 Tooting - August Others 6 Comments Oxford July Major concerning systems for management of deviations 3 Others 1 Comment 2

3 APRIL TO JUNE 2011 Cambridge June Others 6 Comments Filton June Others 3 Comments Plymouth June Others CPA, Colindale and Tooting May July other non conformances CPA Filton, Histocompatibility & Immunogenetics May July Other CPA Birmingham, Histocompatibility & Immunogenetics May July Others 1 Comment Liverpool IMP Inspection May Others 1 Comment HTA Filton SCI April Other 5 Advice and guidance HTA Oxford SCI - April Other 4 Advice and guidance HTA Birmingham SCI April Other 6 Advice and guidance HTA Sheffield SCI April Other 1 Advice and guidance 3

4 APPENDIX 2: SCHEDULED AND ANTICIPATED EXTERNAL INSPECTIONS 2012/13 April May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Birmingham Brentwood Cambridge Colindale Filton Lancaster JACIE CPA(IBGRL) HTA Leeds Liverpool Manchester JACIE 20th BE & HTA IMP UL Newcastle Oxford EFI Plymouth Sheffield EFI Southampton JACIE 5th Tooting HTA CBC Wolfson 6th 4

5 APPENDIX 3: DETAILS OF HTA REPORTABLE EVENTS JANUARY TO MARCH 2012 Filton SCI - patient experienced graft failure approximately five months post transplant. Cord Blood Unit initially engrafted and patient was doing well until an episode of Human Herpes Virus Type Six (HHV-6) infection which resulted in graft failure. NHSBT investigated and the transplant team suggested that as the patient had evidence of HHV6 infection, this might have been acquired from the cord blood unit, reactivated and caused the graft failure. The unit tested positive for HHV6 retrospectively and this supports the diagnosis, assuming that the patient had no evidence of HHV6 infection prior to the transplant. HHV6 infection occurs in approx 1% of cord blood units (the same as CMV) and is more likely to emerge as a cause of clinical problems in recipients of cord blood transplants than other sources of stem cell probably because of reactivation of the patients HHV6. At the present time routine testing of cord blood units for HHV6 is not recommended. There is no planned corrective or preventative action as a result. A new transplant was planned using the father as a donor. OCTOBER TO DECEMBER 2011 Liverpool Tissues - An Aortic Valve was issued for use; the hospital routinely cultures the tissue before use. They isolated Candida from the graft post thawing and prior to implantation. Implantation went ahead. The investigation concluded that NHSBT was not at fault because the root cause was established as the graft being contaminated by instruments used during the operation that were contaminated with an organism present in the patient's blood pre-operatively. Liverpool SCI - The transplant co-ordinator for Blackpool Victoria informed the SCI laboratory that they would be requesting further cells from a stem cell donation as it appeared that the cells transplanted on the 16 November were not engrafting. The remaining three bags were requested. Root cause is still under investigation at the time of writing. Sheffield SCI- A unit of cord blood was sourced from a bank abroad. It was thawed and washed at SCI Sheffield, it demonstrated good viability. It was infused to a paediatric patient with severe aplastic anaemia without incident. Initially there was some sign of neutrophil engraftment, but this died away and the recipient became completely aplastic. The recipient became red cell and platelet dependant, although still well. Examination of plant, people, procedure, premises and product indicated that there were no failures at any point. The product issued was processed using validated equipment, a validated procedure and by trained personnel. The product issued was within specification. No root cause could be identified. 5

6 Filton - SCI - Patient died halfway through an autologous peripheral blood stem cell transplant. The patient received ten bags of cells on 04/10/11 and was scheduled to receive a further 17 bags of cells over the next two days. The patient was transferred to intensive care before commencing the second day of infusion on 05/10/11. During bag four of the eight bags due to be infused that day the patient had a PEA / Asystolic arrest. Patient files were reviewed and the process discussed. SCI staff confirmed that the procedure was adequate and no areas were identified for review or improvement within NHSBT. JULY TO SEPTEMBER 2011 Oxford STS - Patient was undergoing a stem cell harvest when the Cobe Spectra machine alarmed. The engineer was not able to resolve the problem remotely and so the decision was taken to abandon the procedure and restart using a different machine. The patient lost a small volume of red cells as a consequence of this machine failure but was already booked for a red cell transfuion immediately after the procedure (because of a low pre-procedure Hb). The procedure was re-started and was successful with no adverse consequences for the patient. Filton Testing - On a NAT worklist the cord blood donation testing list displayed HIV NAT as an additional test rather than Malaria Ab, and Malaria Ab rather than T. Cruzi Ab. Due to the error in the worklist, discretionary testing for Malaria Ab or T Cruzi Ab had not been performed since the software update on 19 July A software update has been implemented to ensure that in future similar donations will be tested correctly.there was no risk to patients as full testing would have been carried out before release of the material. Oxford STS - A patient attended clinic for a stem cell harvest, the procedure was completed and the product taken to SCI. The sample was sent away for testing due to problems with the flowcytometer. The event was reported as HTA have advised that unnecessary treatment such as GCSF administration should be reported. The patient was advised that a second harvest was not required as more than the target dose had been collected on day one. Liverpool Tissues - An Aortic Heart Valve was issued instead of a Pulmonary Valve. The pulmonary valve is preferred for ease of handling and incidence of calcification is less compared to an aortic valve. In this case the graft was used in a child with Tetralogy of Fallot with branch pulmonary Artery stenosis. The surgeon provided feed back that this has not created any problem during the implantation and that he did not expect that this would create any problems in the future to the patient. Root cause identified as operator error in that the tissue was not checked adequately prior to issue. In the interim the operator was only allowed to issue tissue under supervision, they were then retrained and signed off as competent. 6

7 Liverpool Tissues - A Hospital Services staff member noted whilst validating a fresh frozen femoral head that the top Tissue Services donation number was different from the base donation label applied by the theatre staff. There had been a labelling error which could have caused problems should a recall have been required. No recall was required and there was no clinical risk, but it was reportable to HTA as a Quality Management System failure. Four contributory causes were identified: The operator was distracted during validation. Poor left to right working practice. Lack of understanding of Pulse warning messages and Poor use of reconciliation. Procedures were reviewed and updated and all operators who perform validation of frozen tissue were re-trained. APRIL TO JUNE 2011 No reports made. 7

8 APPENDIX 4: DETAILS OF CRITICAL ADVERSE EVENTS JANUARY TO MARCH 2012 Liverpool - STS Adverse Event Report - Adverse Reaction Death during plasma exchange, but not attributed to the procedure undertaken by NHSBT. Colindale Hospital Services - There was also an ABO labelling error which was originally classified as a Major Quality Incident. The event was further investigated by carrying out an audit which resulted in a Critical audit non conformance being raised as it identified a number of elements of the QMS system that were not under adequate control at the Colindale Blood Centre. The issues identified were, lack of a systematic approach to staff training and process compliance; insufficient staff with the right skill mix; a key change to a critical GMP process and premises was not managed through change control; insufficient space in the validation area to accommodate the process safely. The labelling error was identified by our QMS reconciliation checks and would have also been identified when the unit was presented to PULSE in accordance with the routine procedure prior to product release. A Root Cause Analysis has also been completed, resulting in an extensive corrective action plan which is currently being implemented. OCTOBER TO DECEMBER 2011 Oxford STS - A patient seen at the Oxford Clinical Apheresis Unit on 16th and 17th November for stem cell harvest became unwell and was admitted to hospital. Cultures from the initial stem cell harvest were clear but subsequent cultures from the patient and collected stem cells have grown gram negative rods identified as serratia marcescens. Cause of the infection had not been identified and although more likely to be from his central line or hospital source the possibility of the infection originating from NHSBT equipment, saline or anticoagulant solutions can not be ruled out. Not required to be externally reported. The source of the infection has not been identified by the investigating team but this is not unexpected. The balance of probabilities is that it arose prior to NHSBT involvement. Infections with this organism have occurred in association with multi-use vials of drugs. Re accessing drug vials for multiple patients on multiple occasions is unusual practice in the NHS generally and does not occur in NHSBT, all drugs, fluids and consumables used in stem cell harvesting are sterile and disposed of after single use. None of the other stem cell harvest patients treated with the same batches of consumables over the last month have grown this organism. The drugs were obtained from the hospital pharmacy. No other OUH patient has grown this organism, making contamination of fluids, drugs and consumables used in NHSBT as the source of infection extremely unlikely. 8

9 Filton - SCI - Patient died halfway through an autologous peripheral blood stem cell transplant. The patient received ten bags of cells on 04/10/11 and was scheduled to receive a further 17 bags of cells over the next two days. The patient was transferred to intensive care before commencing the second day of infusion on 05/10/11. During bag four of the eight bags due to be infused that day the patient had a PEA / Asystolic arrest. Reported to HTA. Patient files were reviewed and the process discussed. SCI staff confirmed that the procedure was adequate and no areas need to be reviewed or improved at this time. Oxford - Potential TRALI Event - 46 year old female, had Glanzmann s thrombasthenia and gastric ulceration and under went elective partial gastrectomy for chronic bleeding symptoms. She had intra and post-op bleeding and was transfused resulting in respiratory deterioration. During a further transfusion episode the patient suffered cardiac arrest and died despite treatment. Hospital reported to SHOT/SABRE. The post mortem indicated no features of TRALI; transfusion is unlikely to be related to the cause of death. No further action by NHSBT was required. JULY TO SEPTEMBER 2011 Leeds BD - Serious Adverse Event of Donation (SAED) at Bradford Centre. The donor had given seven previously uneventful whole blood donations but suffered acute coronary syndrome about six hours after his 24th uneventful component donation. There was no risk to the recipient but the donor has required angioplasty following this very rare adverse event. The donor has been withdrawn from the donor panel. Leeds A patient died during the transfusion of a second unit of red cells on the haematology day ward at Hull Royal Infirmary. He complained of breathlessness and chest pain and became agitated. The case was discussed with the coroner and he decided that no post mortem examination was required; it was accepted as death due to myocardial infarction. This event is closed. Leeds STS - A patient died during plasma exchange by NHSBT Special Therapeutic Services staff at St James hospital, Leeds. Death was sudden but was not unexpected by the hospital team and is thought to be unrelated to the treatment carried out by NHSBT. We are still awaiting the final coroners report. Filton - Incorrect information was sent to Princess Anne Hospital suggesting that Neonatal Alloimmune Thrombocytopenia (NAIT) may be a potential outcome of a pregnancy when our diagnostic results indicated that NAIT would be inevitable. As a result the mother underwent an unnecessary amniocentesis procedure. Root cause analysis identified a number of contributory factors which are being addressed via a thorough corrective action plan. 9

10 APRIL TO JUNE 2011 Newcastle - A fatal anaphylactic reaction was recognised as a potentially rare complication of transfusion, however we could not rule out the possibility that death was caused by the patients underlying medical condition. Manchester - The event was initially suspected to be caused by Transfusion Related Acute Lung Injury (TRALI), but this was confirmed not to be the case. Sheffield - A possible Transfusion Transmitted Infection was initially reported, but later excluded due to lack of growth in a sample from the transfused component. 10

11 APPENDIX 5: CURRENT DOCUMENTS OVERDUE REVIEW Owner Directorate Docume nt Count Overd ue review % Overdu e Business Transformation Information Technology (IT) Emergency Planning Service CLINICAL Blood Donation (BD) Human Resources (HR) Patient Services (PS) Specialist Services (SpS) Quality Assurance (QA) Organ Donation & Transplant (ODT) Finance (FIN) Estates & Logistics (DEL) Total